louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04542434: Niclosamide in COVID-19
Official title: A Phase 2 Randomized Double Blind, Placebo-controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Covid19
Lead sponsor: Entero Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 0
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: This is a two-part, Phase 2, multicentre, randomized, double blind, 2-arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms


Eligibility criteria: Inclusion Criteria:

* Part 1 only: Patients hospitalized with a primary diagnosis of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.

Part 2 only: Patients with a primary diagnosis of COVID-19 with or without pneumonia who are not planned to be hospitalized.

* Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least solid-formed 3 stools per week and no more than 3 solid-formed stools per day.
* SARS-CoV-2 RNA presence in rectal swab (or stool test) ≤2 days before randomization by local or central lab.
* Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment

Exclusion Criteria:

* At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
* Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.

Primary outcomes:
measure: Mortality
timeFrame: From Day 1 to 6 weeks
measure: TEAE
timeFrame: From Day 1 to 6 weeks
measure: SAEs
timeFrame: From Day 1 to end of study
measure: Safety laboratory
timeFrame: From Day 1 to 6 weeks
measure: Blood pressure
timeFrame: From Day 1 to 6 weeks
measure: fecal RNA virus clearance
timeFrame: From Day 1 to 6 weeks
measure: Body temperature
timeFrame: From Day 1 to 6 weeks
measure: Heart rate
timeFrame: From Day 1 to 6 weeks
measure: SaO2
timeFrame: From Day 1 to 6 weeks
measure: ECG
timeFrame: From Day 1 to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02003534: A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 376
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* Used Alphagan® in previous 3 months

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
timeFrame: Baseline, Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02133534: The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease
Official title: The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Kidney Disease
High Cholesterol
Keywords: Chronic kidney disease
High cholesterol
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if patients with chronic kidney disease have endothelial cells that don't function properly, which is thought to be a marker for cardiovascular risk. Endothelial cells line the heart and blood vessels. The investigators will treat your high cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine if this cholesterol lowering drug improves subjects' cholesterol as well as the function of endothelial cells.


Eligibility criteria: Inclusion Criteria:

* Stage 3, 4 and 5 chronic kidney disease (not on dialysis)
* Hyperlipidemia requiring cholesterol lowering therapy
* Aged 18 to 80 years old
* Ability to provide informed consent

Exclusion Criteria:

* Patients requiring multiple cholesterol reducing agents
* Patients with neovascularization present, such as neoplasm, active wounds, or significant retinopathy
* Patients with contraindications or allergy to statins

Primary outcomes:
measure: Improved Counts of Endothelial Progenitor Cells
timeFrame: baseline, 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Lynda Szczech, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06268834: Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome
Official title: Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome: A Cross-Sectional Case-Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proton Pump Inhibitor Adverse Reaction
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

Brief summary: Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels.

Detailed description: The study included a total of 75 participants, with 45 individuals classified as long-term PPI users and 30 as non-PPI users. The PPI user group was defined as those who had been consistently using PPIs (specifically omeprazole, lansoprazole, pantoprazole, esomeprazole, or rabeprazole) on a daily basis for a minimum of 6 months or at least twice a week for a minimum of 2 years. The control group comprised individuals who had never used PPIs. Venous blood samples were taken from all participants to measure serum zonulin levels.

Eligibility criteria: Inclusion Criteria:

The patient group was patients taking long-term PPIs (omeprazole, lansoprazole, pantoprazole, esomeprazole and rabeprazole) every day for at least 6 months or at least twice a week for at least 2 years.

A control group was formed from individuals who had never used PPI.

Exclusion Criteria:

Those with inflammatory bowel disease, celiac disease, type 1 diabetes, active gastroenteritis, acute kidney failure, chronic kidney failure, and those who had used antibiotics for any reason in the last 3 months, as well as those receiving probiotic drug support, were not included in the study

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Primary outcomes:
measure: Zonulin levels in long-term proton pump inhibitor users
timeFrame: Blood was drawn and collected during the examination and studied collectively after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Study officials:
References:
citation: Fasano A, Shea-Donohue T. Mechanisms of disease: the role of intestinal barrier function in the pathogenesis of gastrointestinal autoimmune diseases. Nat Clin Pract Gastroenterol Hepatol. 2005 Sep;2(9):416-22. doi: 10.1038/ncpgasthep0259.
citation: El Asmar R, Panigrahi P, Bamford P, Berti I, Not T, Coppa GV, Catassi C, Fasano A. Host-dependent zonulin secretion causes the impairment of the small intestine barrier function after bacterial exposure. Gastroenterology. 2002 Nov;123(5):1607-15. doi: 10.1053/gast.2002.36578.
citation: Haastrup PF, Thompson W, Sondergaard J, Jarbol DE. Side Effects of Long-Term Proton Pump Inhibitor Use: A Review. Basic Clin Pharmacol Toxicol. 2018 Aug;123(2):114-121. doi: 10.1111/bcpt.13023. Epub 2018 May 24.
Clinical trial NCT01406834: Treatment for the Mental Health Impact of Killing in War
Official title: Treatment for the Mental Health Impact of Killing in War: Augmentation of Existing Evidence-Based Mental Health Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: PTSD
Veterans
Killing
Military
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2011-08-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Combat veterans

Brief summary: The goal of this project is to test the feasibility, acceptability, and efficacy of a treatment module addressing the mental health and functional impact of killing in the war zone.

The investigators will enroll between 12-20 Veterans who have killed in war and have been diagnosed with post-traumatic stress disorder (PTSD) for a pilot study assessing the efficacy of the six-session treatment. Veterans will be randomized either to the treatment or to the waitlist control group.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PTSD
* Veteran will need to endorse having taken another life in a war zone context
* Have received some prior evidence-based treatment for PTSD

Exclusion Criteria:

* Meet current or lifetime criteria for a psychotic disorder
* Participants in current PTSD treatment will not be excluded;however,if receiving medications they will need to be stabilized on current medications for at least one month.
* If receiving Prolonged Exposure Therapy or Cognitive Behavioral Therapy, individuals will need to wait two weeks after they have completed the treatment to enroll in the study.

Primary outcomes:
measure: Change in psychological symptoms as measured by the Symptom Checklist-90 (SCL-90-R)
timeFrame: Measured at baseline and study completion (week 7)
Secondary outcomes:
measure: Change in killing-related maladaptive cognitions as measured by the Killing Cognitions Scale (KCS)
timeFrame: Measured at baseline and study completion (week 7)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California San Francisco/ San Francisco VA Medical Center
name: Shira Maguen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03765034: Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury
Official title: Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Brachial Plexus Palsy
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care occupational therapy in children with perinatal brachial plexus injury. Participants are randomized to receive either the intervention (CIMT) or control first, then cross over to receive the other one.

Detailed description: Children with perinatal brachial plexus injury routinely receive occupational therapy intervention to improve strength and function in their weak or paralyzed arm.

Constraint-induced movement therapy (CIMT) is known to increase upper extremity function in children with weakness or disuse as a result of cerebral palsy. However, it is unknown if this therapy is effective for treating arm weakness or disuse as a result of perinatal brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care is evaluated in this trial.

Eligibility criteria: Inclusion Criteria:

* Participant has perinatal brachial plexus injury
* Participant walking at time of study inception
* Ability to cooperate with interventions and assessment
* Participant currently receiving occupational therapy 1+ hour per week and planning to continue for duration of study

Exclusion Criteria:

* Co-morbid diagnosis not related to perinatal brachial plexus injury
* Flaccidity of the involved upper extremity or no observable hand function
* Planned surgery or drug intervention during the study period
* Allergy or intolerance to constraint intervention materials

Primary outcomes:
measure: Assisting Hand Assessment 5.0
timeFrame: change from baseline at 8 weeks and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02249234: Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain
Official title: Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scrotal Pain
Keywords: Scrotal pain
Botox
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 64
Sex: MALE
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: There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published.

We proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using local anaesthetic drug.

The encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo.

We hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal pain.


Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Have nociceptive scrotal pain,
* Have no identifiable, reversible causes for the scrotal pain
* Have failed standard medical therapy
* Have responded temporarily to cord blocks

Exclusion Criteria:

* Are interested in trying to conceive with their partners in the next 6 months,
* Have any local infection near the site of the injections,
* Have had an allergic reaction to Botox in the past,
* Are unable to provide informed consent
* Have a history of motor neuron disease or neurogenic bladder
* Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto (rivaroxaban) or other blood thinners

Primary outcomes:
measure: Reduction in the visual analog scales for pain
timeFrame: 6 months after entering in trial
Secondary outcomes:
measure: Reduction in scrotal pain
timeFrame: 6 months after entering in trial
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Keith Jarvi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02840734: Effects of Kinesio Taping on Performance
Official title: Kinesio Taping and Muscular Function in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Kinesio taping
Obese adults
Muscular function
Fatigue
Lead sponsor: Texas A&M University San Antonio
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study investigated the immediate effects of Kinesio taping on muscular power, strength, endurance, and lower limb fatigue when taping is applied to rectus femoris and around the patella of obese adults based on Kinesio taping techniques.

Detailed description: This is a randomized, double-blind, crossover, and clinical trial. Ethical approval was obtained from the University's Institutional Review Board (#2015-51). Participants were recruited by flyers posted on the University campus. Informed consent was completed by all participants prior to the study procedures. The subjects were obese college students. A total of 13 subjects, four males and nine females (mean age of 24.38 ± 3.01 years, mean percent body fat of 39.10 ± 6.91 % \[male: 41.93 ± 7.47 %, female: 38.16 ± 6.91 %\]), were enrolled this study. All subjects underwent three different trials which include no taping (NT), placebo taping (PT), and Kinesio taping (KT). All individuals were assessed for peak and mean power, muscular strength, endurance, and muscle fatigue after each condition.

Eligibility criteria: Inclusion Criteria:

* percent body fat of 25 % in males, 30 % in females or more

Exclusion Criteria:

* lower limb surgery within previous 6 months
* presence of any other lower limb joint diseases such as degenerative arthritis, rheumatoid arthritis.

Primary outcomes:
measure: Physique characteristic
timeFrame: 1 week (Each subject was measured their anthropometrics variables in an Initial visit the LAB for trial)
Secondary outcomes:
measure: muscular power
timeFrame: 4 weeks (30 minutes after applied each trial)
measure: muscular strength
timeFrame: 4 weeks (30 minutes after applied each trial)
measure: muscle fatigue
timeFrame: 4 weeks (immediately after be completed each trial)
Other outcomes:
Locations:
Study officials:
affiliation: Texas A&M University San Antonio
name: Sukho Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02916134: Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
Official title: Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare antibiotic treatment versus surgery for patients with uncomplicated appendicitis.

Detailed description: The study will include patients aged 16 and over, with a first admission with right iliac fossa pain and a raised white cell count or C-reactive protein. Patients will be randomised electronically in a 1:1 ratio either to undergo emergency appendectomy or to receive intravenous antibiotics as an inpatient, until clinical and biochemical improvement is observed, followed by outpatient oral antibiotics. Those who have surgery will have 3 post-operative doses of intravenous antibiotics, unless perforation was identified at the time of surgery, in which case, microbiology will be contacted to advise regarding antibiotic choice and duration. Follow-up by telephone interview will be at 1 week, 1, 3 and 12-month intervals.

Eligibility criteria: Inclusion Criteria:

* Right iliac fossa pain
* 1st episode in the past 1 year
* Raised WCC or CRP
* Fluent in English

Exclusion Criteria:

* History of inflammatory bowel disease or appendectomy
* B-HCG positive
* Significant co-morbidities
* Complicated appendicitis as proven by ultrasound, CT or MRI
* Anaphylaxis to penicillin

Primary outcomes:
measure: Successful treatment of appendicitis
timeFrame: 1 year post enrollment
Secondary outcomes:
measure: Recurrence of appendicitis
timeFrame: 1 year post enrollment
measure: Clostridium difficile infection
timeFrame: 1 year post enrollment
measure: Need for re-admission or repeat imaging
timeFrame: 1 year post enrollment
measure: Quality of life Questionnaire taken over the year after recruitment
timeFrame: 1 year post enrollment
measure: Complication of treatment
timeFrame: 1 year post enrollment
measure: Cost evaluation
timeFrame: 1 year post enrollment
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Beaumont Hospital
name: Arnold K Hill
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522534: Randomized Double Blind Controlled Trial Comparing a Blind Sciatic Nerve Block in the Popliteal Fossa to Intravenous Morphine for Traumatic Severe Acute Pain in the Prehospital Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Injuries
Pain
Emergencies
Keywords: injuries
pain
Block, Nerve
morphine
Prehospital Emergency Care
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 26
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 purpose of the study is to determine the efficacity of a simple blind technic of loco regional anaesthesia of the sciatic nerve compared to the gold standard in emergency medecine : the intravenous morphine for treated the severe pain of leg, ankle or foot trauma in the prehospital setting and mountain rescue.

Detailed description: Severe pain due to leg, ankle or foot trauma do not beneficiated of a simple loco regional anaesthesia technic. Loco regional anesthesia is superior to intravenous morphine for treating severe pain and specially during transportation and mobilization of the patient. The purpose of the study is to assessed a new technic of blind sciatic nerve block in the popliteal fossa in the pre hospital setting compared to the intravenous morphine. The blind technic is a modified technic of the classic sciatic nerve block with nerve stimulation.

Eligibility criteria: Inclusion Criteria:

* Severe pain (VAS \> or = 60mm); injuries of the leg, ankle or foot

Exclusion Criteria:

* Hypersensitivity to student agents
* Local infection
* Nerve or vascular pathology in the affected limb, coagulation pathology,
* Chronic use of opoids, use of opoids within 6 hours
* Drug addiction
* Pregnancy
* Systolic blood pressure less than 90 mmHg
* Respiratory rate less than 16 per minute
* Glasgow coma scale \< 14.

Primary outcomes:
measure: Visual analog scale pain score
timeFrame: 30 minutes
Secondary outcomes:
measure: Total dose of morphine
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Albertville
country: France
facility: Centre Hospitalier d'Albertville moutiers
city: Annecy
country: France
facility: Centre Hospitalier de la Region d'Annecy
city: Chambery
country: France
facility: Centre Hospitalier de Chambéry
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de GRENOBLE
city: Morzine
country: France
facility: Centre medical d'Avoriaz
city: Sallanches
country: France
facility: Centre Hospitalier Sallanches Chamonix
Study officials:
affiliation: Centre Hospitalier Annecy Genevois
name: Francois Xavier AGERON, MD
role: PRINCIPAL_INVESTIGATOR
References: