louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04365322: Study of Specific Viral Immune Responses Induced by SARS-CoV-2 (COVID-19)
Official title: Étude Des réponses Immunitaires Lymphocytaires spécifiques Chez Des Patients infectés Par le Virus SARS-CoV-2 : Caractéristiques Des Réponses Effectrices et Mémoires
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2 Infection
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COVID-19 or convalescent.

Brief summary: SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19. The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specific immune responses. COV-CREM is a French prospective monocentric study that will evaluate viral-specific cell responses in positive patients for SARS-CoV-2 on the basis of (RT-PCR) assay performed in respiratory tract sample tested by our local Center for Disease Control.


Eligibility criteria: Inclusion Criteria:

* COVID-19 PCR positive,
* Hospitalized patients with illness of any duration, and/or SpO2 ≤ 92% on room air.
* Cohorte C : patients with cancer (hematological malignancies and solid tumors).

Exclusion Criteria:

* Refusal to participate,
* Any immunosuppressive therapy (i.e. corticosteroids \>10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study,
* Active or chronic hepatitis B or C and/or HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus,
* Active autoimmune disease that required a systemic treatment, with the following exceptions:

  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,
  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,
* Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
* Patients currently exposed to chemotherapy, anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy or biotherapy (except for patients in cohort C),
* Previous prescribing of biotherapy or treatment for the management of COVID-19 is not an exclusion criterion,
* Patient under guardianship, curatorship or under the protection of justice.

Primary outcomes:
measure: Specific immune responses
timeFrame: During COVID-19 infection or one month after COVID-19 infection
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Jean Minjoz
Study officials:
References:
Clinical trial NCT05853822: FirmTech User Research Trial
Official title: FirmTech User Research Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Function
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
Collaborators: name: FirmTech, Inc.
First posted: 2023-05-11
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample from social media recruitment

Brief summary: The objective of this study is to see whether a home-use penile constriction device, Firmtech Tech Ring, can be determined to be superior to the Giddy device through evaluation of Leikert scale scores to assess ease of use and participant comfort and satisfaction with erectile quality with these devices. The primary outcome will be the satisfaction with use of the device as assessed through the Leikert scores. The other outcomes will be secondary.


Eligibility criteria: Inclusion Criteria:

* All English-speaking participants \> 18 years old recruited through social media.
* Physically and emotionally capable of engaging in sexual activity with at least one attempt per week of masturbation or sexual intercourse

Exclusion Criteria:

* Men who cannot understand English.
* Men with a prior or current penile implant.
* Transgender or non-binary individuals
* Men diagnosed with a hidden or buried penis.
* Investigator's impression of expected poor participant compliance or anatomic inadequacy (penile size/girth)
* Any psychiatric disorder, which, in the opinion of the investigator, would prohibit participation.
* Coagulopathy or other blood disorder which the investigator determines would affect the participant's participation in the trial.
* Any tumor in the pelvic or penile region within the last 3 years
* Men with an active caregiver who are unable to live independently.
* Men who the provider is concerned would be at high risk for non-healing wounds of the penis.
* Participants with sensory disorders like sensory processing disorder, sensory integration dysfunction disorder, neuropathies, etc.

Primary outcomes:
measure: Device satisfaction via Leikert scores
timeFrame: 2 weeks after receiving device
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: IVI RMA New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT03338322: Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive
Official title: Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive In Instrumentation Of Necrotic Mandibular Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
reciproc
twisted file adaptive
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: assess the effect of using reciprocating motion with reciproc files versus adaptive motion using twisted file adaptive on postoperative pain after instrumentation of necrotic mandibular molars.

Detailed description: In root canal treatment of mandibular molar teeth in patients having necrotic pulp with symptomatic or asymptomatic apical periodontitis, Is there difference in postoperative pain after instrumentation between two different kinematics; adaptive motion using Twisted File Adaptive and reciprocation motion using Reciproc

Eligibility criteria: Inclusion Criteria:

1. Patients who are medically free from any systemic disease that may contraindicate our interventions.
2. Patient's age between 18-60 years old.
3. Mandibular molars having necrotic pulps with symptomatic or asymptomatic apical periodontitis because this group of patients may have more postoperative pain than vital teeth22.
4. Positive patient's acceptance for participation in the study.

Exclusion Criteria:

1. Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain after instrumentation.
2. Teeth with vital pulps or Symptomatic irreversible pulpitis.
3. Pregnant patients or lactating because of radiographic hazards and use of analgesics27.
4. Any known sensitivity or adverse reactions to ibuprofen.

Primary outcomes:
measure: Post instrumentation pain
timeFrame: up to 7 days
Secondary outcomes:
measure: analgesic intake
timeFrame: up to 7 days
measure: Colony forming units
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05827822: Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") in China
Official title: Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") Among Hazardous and Problematic Drinkers in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol Abuse
Keywords: hazardous drinking
alcohol use disorders, AUDs
WeChat-based digital intervention
randomized controlled trial
mixed methods approach
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore whether "Sober Time ACT", a digital intervention tool for alcohol use developed based on wechat mini program, is effective in improving risky alcohol use among Chinese local drinkers.


Eligibility criteria: Inclusion Criteria:

* Above the age of 18
* The total score in line with the AUDIT scale ≧8
* Provide at least one backup contact information
* Non-illiterate, able to use smart phones without barriers
* Wechat version support small program function (6.5.3 and above)
* Understand the nature of this study and sign the informed consent

Exclusion Criteria:

* Other interventions and treatments to reduce alcohol use were given during the trial
* Severe primary or secondary cognitive dysfunction, unable to complete the screening scale and baseline questionnaire

Primary outcomes:
measure: Average number of risky drinking days per month
timeFrame: one month
Secondary outcomes:
measure: Average weekly alcohol consumption
timeFrame: one month
measure: craving level
timeFrame: two weeks
measure: Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) score
timeFrame: three months
measure: willingness and confidence to abstain
timeFrame: one month
measure: stages of motivation for abstinence change
timeFrame: one month
measure: Depression, PHQ-9
timeFrame: one month
measure: Anxiety, GAD-7
timeFrame: one month
measure: Sleep status, ISI
timeFrame: one month
measure: Stress perception, PSS-10
timeFrame: one month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
Clinical trial NCT03759522: Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
Official title: Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Fibromyalgia
Chronic Fatigue Syndrome
Multiple Sclerosis
Healthy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical \[F-18\]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer \[F-18\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with \[F-18\]DPA-714-PET/MRI.


Eligibility criteria: Inclusion Criteria:

1. 18 to 65 years of age
2. Healthy volunteer OR Clinical diagnosis of Multiple Sclerosis (MS) OR Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome

Exclusion Criteria:

1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
5. Chronic infectious disease (e.g. HIV, HCV)
6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
7. Diagnosis of cancer, including leukemia
8. Blood or blood clotting disorder
9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
10. Positive urine β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of \[18F\]DPA-714
11. Currently enrolled in a clinical trial utilizing experimental therapies

Primary outcomes:
measure: Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Medical Center
state: Alabama
Study officials:
References:
Clinical trial NCT05635422: Isokinetic Fatigue Index in a Population of Triathletes
Official title: Pilot Study to Evaluate an Isokinetic Fatigue Index for Prevention Purposes in a Population of Triathletes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Diseases
Lead sponsor: Boulogne sur Mer Hospital Center
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the relevance of carrying out a measure of muscular fatigability by isokinetism, in the search for factors favouring micro-traumatic lesions of the lower limbs in a population of triathletes.

This is a prospective monocentric pilot study of the before/after type in which the patient is his or her own control, in high-level triathletes practising an endurance sport, who have had more than 7 consecutive days off running due to a musculoskeletal injury during the previous sporting year.


Eligibility criteria: Inclusion Criteria:

* Having had a practical running break of more than 7 consecutive days due to a musculoskeletal injury of a lower limb during the previous sport year
* Willing to comply with all study procedures
* Having given written consent
* Socially insured

Exclusion Criteria:

* Pain that does not allow an isokinetic test to be performed
* Knee joint amplitude less than 100° of flexion or flessum greater than 5°.
* History of rupture or ligamentoplasty of the anterior cruciate ligament less than 2 years ago
* History of knee surgery less than 2 years

Primary outcomes:
measure: fatigue index between the injured leg and the healthy leg
timeFrame: the day of inclusion
Secondary outcomes:
measure: difference of the fatigue index to the difference of the Croisier ratio between the injured leg and the healthy leg
timeFrame: the day of inclusion
Other outcomes:
Locations:
city: Boulogne-sur-Mer
country: France
facility: Boulogne sur mer Hospital Center
Study officials:
References:
Clinical trial NCT04871022: Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean
Official title: Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Scar Defect
Keywords: niche
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard.

This study compares two techniques of uterine closure on myometrium thickness:

1. Double layer unlocked suture;
2. Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium.

The primary outcome is the mean residual myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.


Eligibility criteria: Inclusion Criteria:

* Planned cesarean
* Primary cesarean
* ≥ 38 gestational weeks

Exclusion Criteria:

* Previous cesarean
* Women \< 18 years old
* Multiple gestation
* Mullerian anomalies
* Active labor
* Diabetes
* BMI \>35 kg/m2
* Placenta praevia
* Chronic systemic disease
* Covid-19 infection

Primary outcomes:
measure: Residual myometrium thickness
timeFrame: 6 months after intervention
Secondary outcomes:
measure: Operative time
timeFrame: Same day of intervention: day 1
measure: Estimated blood loss
timeFrame: Same day of intervention: day 1
measure: Mean number of haemostatic sutures
timeFrame: Same day of intervention: day 1
measure: scar width
timeFrame: Same day of intervention: day 1
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: University hospital Mongi Slim la Marsa
state: La Marsa
Study officials:
References:
Clinical trial NCT00448422: Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
Official title: A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bacterial Gastroenteritis
Keywords: Traveler's
Diarrhea
Lead sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2007-03-16
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of patients with acute bacterial gastroenteritis (traveler's diarrhea.

Detailed description: This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe other gastrointestinal-related symptoms, or tenesmus of \<72 hours duration.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute bacterial gastroenteritis
* Traveler from an industrialized country
* Capable of giving Informed Consent

Exclusion Criteria:

* Fever (\>100.3 degrees)
* Pregnant or Breast Feeding or Not using adequate birth control
* Known or Suspected (co-)Infection with non-bacterial pathogen
* Symptoms of acute gastroenteritis of \>72 hours duration
* Bloody Diarrhea
* Concomitant antibacterial with activity against enteric bacterial pathogens
* History of IBD
* Unable/Unwilling to comply with study protocol
* Greater than two doses of an antidiarrheal medication within 24 hours
* \> 2 doses of anti-diarrheal medication within 24 hours
* Antimicrobial treatment within 30 days

Primary outcomes:
measure: Time to Last Unformed Stool (TLUS)
timeFrame: End of Therapy
Secondary outcomes:
measure: Microbiologic eradication rates
timeFrame: End of therapy/study
measure: Clinical cure based on relief of signs and symptoms
timeFrame: End of therapy/study
Other outcomes:
Locations:
city: Bambolim
country: India
facility: Goa Medical College
state: Goa
Study officials:
affiliation: University of Zurich
name: Robert Steffen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02709122: Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax
Official title: Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax: A Randomized, Crossover Manikin Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tension Pneumothorax
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to determine the level of knowledge and skills to recognize and decompression of tension pneumothorax


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy

Primary outcomes:
measure: physiological parameter
timeFrame: intraoperative
Secondary outcomes:
measure: Procedure of Pneumothorax decompression
timeFrame: intraoperative
measure: duration of the procedure
timeFrame: intraoperative
measure: Ease-of-use assessed on a visual analog scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Emergency Medicine
state: Masovia
Study officials:
References:
Clinical trial NCT01111422: Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients
Official title: A Randomized Prospective Trial of N-acetyl Cystein in Patients With Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: End-Stage Kidney Disease
Peritoneal Dialysis
Keywords: Antioxidant
Epithelial to Mesenchymal Transition
peritoneal fibrosis
Peritoneal Dialysis, Continuous Ambulatory
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2010-04-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of reactive oxygen species may be responsible for progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the researchers investigated the hypothesis that NAC protect peritoneal membrane damage.

Detailed description: N-Acetylcysteine (NAC) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 1200 mg per day. Patients will be randomly assigned to NAC and control group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.

Eligibility criteria: Inclusion Criteria:

* Maintenance peritoneal dialysis at least 3 months
* Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information

Exclusion Criteria:

* Episode of peritonitis at least 3 months
* Episodes of admission due to other disease at lease 3 months
* Liver disease
* Allergic history with N-acetylcysteine

Primary outcomes:
measure: Peritoneal membrane function
timeFrame: 6 months
Secondary outcomes:
measure: Oxydative stress status
timeFrame: 6 months
measure: Mesothelial cell transformation (Epithelial to Mesenchymal Transition)
timeFrame: 6 month
measure: Residual renal function
timeFrame: 6 month
measure: Peritoneal membrane function
timeFrame: 2 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Ewha Womans University
name: Duk-Hee Kang, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: