louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03009903: Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage
Official title: Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acne
Lead sponsor: MBcure Ltd
Sponsor class: INDUSTRY
First posted: 2017-01-04
Enrollment: 400
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be male or female, ages 14-50. Healthy subjects and acne diagnosed subjects.

Brief summary: This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects.

Detailed description: This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects. An additional P. acnes visual detection method (VISIOPOR ® PP34N) will be used in this study as per PI decision to explore whether there is a correlation between P. acnes bacterial presence and fluorescent signal.

Eligibility criteria: Inclusion Criteria:

1. Adults between 14 to 50 years of age inclusive at the time of signing the informed consent
2. Able to provide written informed consent
3. Subjects who are willing to undergo pore strip treatment using the cosmetically acceptable pore strip product
4. Subjects who are willing to provide comprehensive demographic data using questionnaires

Exclusion Criteria:

1. Unwilling or unable to follow the procedures outlined in the protocol
2. Subjects treated with isotretinoin or tretinion during the 6 months prior to visit 1
3. Subjects treated with immunosuppressant agents
4. Pregnant subjects

Primary outcomes:
measure: Detection and analysis of facial P. acnes presence
timeFrame: Day 0 and week 8 (optional)
Secondary outcomes:
measure: Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.
timeFrame: Day 0 and week 8 (optional
Other outcomes:
Locations:
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Jonathan Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199303: Efficacy of Pre- and Post-Operative Oral Dextromethorphan
Official title: Efficacy of Pre- and Post-Operative Oral Dextromethorphan for Reduction of Intra- and 24-Hr Post-Operative Morphine Consumption for Transabdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy of Dextromethorphan
Morphine Consumption
Pain
Keywords: NMDAreceptor antagonist, dextromethorphan
pain, post-operative
opioid consumption, morphine
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We studied the effect of dextromethorphan (DEX), an N-methyl-d-aspartate antagonist, on analgesic consumption and pain scoring after abdominal hysterectomy. Our aim was to compare the analgesic effectiveness and incidence of adverse side effects of oral DEX with placebo (P)

Detailed description: One hundred patients were randomized to two groups. Group DEX was given 30 mg tablets of oral dextromethorphan with their pre-medication and three more times in the first 24 hours after surgery. Group P received the placebo following the same schedule. Post-operative analgesic requirements were assessed using a patient-controlled analgesia system.

Pain was assessed at rest using a visual analog scale in the post anesthetic care unit(PACU), 6 and 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* women aged between 30 and 60, with an ASA physical status of I or II, undergoing elective total abdominal hysterectomy under general anesthesia.

Exclusion Criteria:

* Women with a history of significant renal or hepatic impairment, allergy to any of the study medications, antitussive or NSAID use (48 hours or 1 week, respectively) before surgery, chronic pain and regular analgesic use, were excluded. Patients taking medications that could interact with dextromethorphan, including quinidine, flecainide, mexiletine, fluoxetine, amitriptyline, nortriptyline, and propafenone

Primary outcomes:
measure: Mean morphine consumption
measure: Mean pain score
Secondary outcomes:
Other outcomes:
Locations:
city: KhonKaen
country: Thailand
facility: Waraporn Chau-in
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand
name: waraporn chau-in, Asso Prof.
role: STUDY_CHAIR
affiliation: Department of Anesthesiology
name: BUSABONG SUKMOUEN, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology
name: KRIANGSAK NGAMSANGSIRISAPT, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology
name: WINITA JIRARAREUNGSAK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04010903: Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
Official title: Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: INSULIN RESISTANCE
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier
First posted: 2019-07-08
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort of subjects with/without overweight and with/without insulin resistance
Primary purpose: DIAGNOSTIC

Brief summary: The study aims at the identification and the quantification of urinary branched-chain amino acids (BCAAs) by mass spectometry in healthy subjects and patients with insulin resistance and correlating urinary BCAAs with HOMA index.

Blood and urine levels of BCAAs will be correlated with HOMA index to assess and quantify insulin resistance.

Identification and quantification of urine BCAAs by an innovative method based on synthetic biology will also be performed.

Correlations between mass spectometry and the innovative detection method of BCAAs will be searched.

Detailed description: Blood and urine samples will be collected in 330 persons to assess BCAAs levels and correlate them with HOMA index.

Persons included will be:

110 persons with BMI\>27 and HOMA \>4 with no diabetes 110 persons with BMI\>27 and HOMA \< 4 with no diabetes 110 persons with BMI \< 27 and HOMA \<4 with no diabetes, including at least 50 men and 50 women, 30 aged 18-35, 30 aged 36-55, 30 aged 56-75.

Urine BCAAs will be measured by both mass spectrometry and the innovative method based on synthetic biology.

Eligibility criteria: Inclusion Criteria:

* no diabetes
* according to studied subpopulations: BMI\<27 and HOMA \<4, BMI\>27 and HOMA\>4, BMI\>27 and HOMA\<4

Exclusion Criteria:

* pregnancy or lactation
* active or suspected chronic infection
* treatment affecting insulin sensitivity

Primary outcomes:
measure: Correlation between urinary levels of BCAAs and HOMA index
timeFrame: through study completion, an average of two years and a half
Secondary outcomes:
measure: Correlation between blood and urine BCAAs levels
timeFrame: through study completion, an average of two years and a half
measure: Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and classic method
timeFrame: through study completion, an average of two years and a half
measure: Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and HOMA index
timeFrame: through study completion, an average of two years and a half
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: UH Montpellier
name: EMILIE BARDE
role: STUDY_DIRECTOR
References:
Clinical trial NCT01061203: Grazax Asthma Prevention
Official title: Grazax Asthma Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Keywords: Rhinitis
allergic
Seasonal
grass
Asthma
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 812
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy

Detailed description: Investigation of the effect of Grazax (ALK produced grass tablet) on asthma prevention in children with grass pollen allergy.

Children in the age of 6-12 years will be randomised to either placebo or Grazax treatment. Grazax has been approved for treatment of grass pollen allergy in adults and children, diagnosed with a positive skin prick test and/or specific immunoglobulin (IgE) test to grass pollen and with clinically relevant symptoms. This study will explore prevention of asthma in children with grass pollen induced allergy.

Eligibility criteria: Inclusion Criteria:

* A history of grass pollen allergy
* Positive Skin prick test to grass
* Positive specific IgE to grass

Exclusion Criteria:

* Asthma

Primary outcomes:
measure: Evaluation of allergy and asthma symptoms
timeFrame: 5 years
Secondary outcomes:
measure: Quality of life and adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Terveystalo Turku
Study officials:
affiliation: Terveystalo Turku, Finland
name: Erkka Valovirta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06583603: Identifying Barriers to Implementing Sensory Strategies in the Classroom Setting
Official title: Identifying Barriers to Implementing Sensory Strategies in the Classroom Setting: a Teacher&#39;s Perspective
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sensory Disorder
Keywords: sensory processing
classroom setting
sensory strategies or sensory treatment
maladaptive behaviors or challenging behaviors
Lead sponsor: Bay Path University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teachers and paraprofessionals who are 18 years and older and are actively working in the classroom setting

Brief summary: The goal of this clinical trial is to determine barriers to implementing sensory strategies in the classroom setting as well as potential supports needed in teachers and paraprofessionals 18 years and older who are actively working in the classroom setting. The main questions it aims to answer are:

1. What are common themes that limit classroom staff from implementing sensory strategies within the classroom setting?
2. What support do classroom staff need from an occupational therapist to feel confident in implementing sensory strategies within their classroom?

Participants will be asked to participate in a 17-item electronic survey via Google Forms. They will be asked to provide informed consent prior to participating.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Active teacher or paraprofessional working in the classroom

Exclusion Criteria:

* Younger than 18 years old
* Teachers or paraprofessionals no longer actively working in the classroom setting

Primary outcomes:
measure: Barriers to implementing sensory strategies in the classroom setting
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bay Path University
name: Allison Niemiec
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06427603: Sit Less and Move More: Feasibility Study
Official title: Sit Less and Move More: A Feasibility Study on Physical Active Break Intervention and Improving Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Intervention aiming to improve cardiometabolic health by reducing prolonged sitting


Eligibility criteria: Inclusion Criteria:

1. are community-dwelling older adults aged 65 years or above,
2. are smartphone users,
3. sit for \>= 6 hours per day
4. are overweight

Exclusion Criteria:

1. are unable to walk independently with/without walking aids due to a physical disability;
2. have health conditions that hinder the adherence to intervention

Primary outcomes:
measure: Intervention feasibility
timeFrame: T2: post-intervention (week 12)
Secondary outcomes:
measure: Sedentary behavior
timeFrame: T1: baseline (before the study begins)
measure: Sedentary behavior
timeFrame: T2: post-intervention (week 12)
measure: Sarcopenia score ranged from 0 to 20
timeFrame: T1: baseline (before the study begins)
measure: Sarcopenia score ranged from 0 to 20
timeFrame: T2: post-intervention (week 12)
measure: Blood glucose
timeFrame: T1: baseline (before the study begins)
measure: Blood glucose
timeFrame: T2: post-intervention (week 12)
measure: Blood pressure
timeFrame: T1: baseline (before the study begins)
measure: Blood pressure
timeFrame: T2: post-intervention (week 12)
measure: Muscle strength (handgrip strength)
timeFrame: T1: baseline (before the study begins)
measure: Muscle strength (handgrip strength)
timeFrame: T2: post-intervention (week 12)
measure: Physical performance
timeFrame: T1: baseline (before the study begins)
measure: Physical performance
timeFrame: T2: post-intervention (week 12)
Other outcomes:
Locations:
city: Ho Man Tin
country: Hong Kong
facility: School of Nursing and Health Studies, Hong Kong Metropolitan University
Study officials:
References:
Clinical trial NCT06820203: Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section
Official title: Comparison Between Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premixed
Sequential
Manually Mixed
Intrathecal
Fentanyl
Bupivacaine
Cesarean Section
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section.

Detailed description: Cesarean section (CS) is a lifesaving procedure when there is both maternal and fetal problems. The rate of CS increases dramatically from time to time. Regional anesthesia techniques are highly preferred for CS compared to general anesthesia.

Coadministration of intrathecal opioids and local anesthetics (LAs) have been found to produce a potent intra and postoperative analgesic synergism without further depression of efferent sympathetic activity, hence results in less adverse hemodynamic effects, even with sub-therapeutic doses of LAs.

Fentanyl has been considered the intrathecal LAs adjuvant of choice owing to its potency, fast onset and short duration of action, and lower incidence of respiratory depression.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 40 years.
* Height between 150 to175 cm.
* Body mass index (BMI) between 18.5 and 30 kg/m2.
* American Society of Anesthesiology (ASA) physical status II.
* Scheduled for cesarean section under spinal anesthesia.

Exclusion Criteria:

* Pre-operation hypotension and bradycardia.
* Preeclampsia.
* Multiple pregnancy and macrosomia.
* Complete or partial failed spinal.
* Patients with skin infections at the site of injection.
* Patients with coagulation disorders.
* Patients with spinal deformities.
* Patients having regional nerve block other than spinal anesthesia.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total analgesic consumption
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Onset of motor block
timeFrame: Intraoperatively
measure: Duration of motor block
timeFrame: Intraoperatively
measure: Onset of sensory block
timeFrame: Intraoperatively
measure: Duration of sensory block
timeFrame: Intraoperatively
measure: Incidence of complications
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT05808803: Aberrant Myeloid Lineage Differentiation in HIV/AIDS Patients
Official title: A Single-center, Retrospective Cohort Study of Aberrant Myeloid Lineage Differentiation in HIV/AIDS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Leukemia
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 782
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association. There were 647 male patients and 135 female patients, aged 14-78 years, with an average age of 43 years.

Brief summary: The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association.


Eligibility criteria: Inclusion Criteria:

* HIV-infection

Exclusion Criteria:

-

Primary outcomes:
measure: The proportion of granulocytes and granulocyte/macrophage progenitors in myelogram of HIV/AIDS patients
timeFrame: 2020
Secondary outcomes:
measure: Neutrophil counts in peripheral blood of HIV/AIDS patients
timeFrame: 2020
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01144403: A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
Official title: A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-06-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m\^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.


Eligibility criteria: Inclusion Criteria:

* adult participants, \>/=18 years of age
* untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
* known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* adequate hematological, renal and hepatic function

Exclusion Criteria:

* known hypersensitivity to murine proteins or chemotherapy regimen
* previous first-line therapy
* history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
* active infection
* clinically significant cardiac disease
* regular corticosteroid treatment in the 4 weeks prior to first dose of study drug

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 50 months (approximately)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the time of enrollment until death due to any cause (up to 50 months [approximately])
measure: Progression-free Survival (PFS)
timeFrame: From the time of enrollment until death due to any cause (up to 50 months [approximately])
measure: Number of Participant With Adverse Event (AE)
timeFrame: Up to 50 months (approximately)
Other outcomes:
Locations:
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Iasi
country: Romania
city: Targu-mures
country: Romania
city: Timisoara
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00018603: Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)
Official title: Guanfacine for the Treatment of PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, placebo-controlled, randomized study lasting 8 weeks. Purpose of the study is two-fold: first, to use a pharmacological agent to treat symptoms of PTSD, and second, to explore neurobiological mechanisms of action of guanfacine.

Detailed description: Subject population is comprised of 100 persons with PTSD. 50 patients will receive guanfacine and 50 patients will receive a placebo. Guanfacine is prescribed at 1 mg/day and may be increased to 2 mg/day. Samples of plasma MHPG will be collected weekly. Clinical ratings of PTSD anxiety and depression, as well as vital signs, will be assessed weekly. Repeated measures analysis of variance will assess significance of main effect of drug, time, and drug by time.

Eligibility criteria: * Males and females, age 18-65
* Diagnosis of PTSD from combat or civilian trauma
* No major medical problems such as diabetes, cardiovascular disease
* Taking no psychiatric medication, or taking only one SSRI antidepressant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
References: