louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00554879: Acupuncture Treatment of Dry Eye
Official title: Acupuncture Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconjunctivitis Sicca
Xeropthalmia
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
Collaborators: name: Malcolm Grow Medical Clinics and Surgery Center
First posted: 2007-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of acupuncture in the treatment of moderate to severe dry eye by replicating the study design of the previous protocol and to see the study through to its completion.


Eligibility criteria: Inclusion Criteria:

* Military healthcare beneficiary
* Male and female patients, at least 18 years of age
* Diagnosis of keratoconjunctivitis sicca or xerophthalmia (dry eyes) in one or both eyes
* Persistent signs and symptoms despite conventional therapy for at least three months

Exclusion Criteria:

* Contact lens wear
* Intraocular surgery or laser in the study eye within 90 days prior to enrolling in the study
* History of any medical condition or circumstance that would preclude scheduled visits or completion of the study
* Known history of adverse reaction to acupuncture
* Pregnancy or breast feeding

Primary outcomes:
measure: To answer the question of whether there are objective beneficial effects of an acupuncture treatment versus sham acupuncture on dry eye, as measured by some of the most widely-used clinical indicators in the literature.
timeFrame: 6 months after acupuncture or sham acupuncture treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: Michael J Mines, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792579: Early Versus Late Stoma Closure After Traumatic Colorectal Injuries
Official title: Early Versus Late Stoma Closure After Traumatic Colorectal Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stoma Colostomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim is to study feasibility,advantages and disadvantages of early closure of stoma versus late closure of stoma

Detailed description: Most traumatic colon injuries can be repaired primarily, but a stoma may still be required for severe colonic or rectal injury. The current trend is to reverse the stoma early, rather than to wait the traditional 3 months before closure)1-3) Trauma patients, however, are usually young and otherwise healthy individuals, with an excellent potential for optimal healing once they have overcome the initial insult. It is these patients who could benefit from early closure of the stoma(4-6). Once the temporary stoma has been constructed, various reasons have been cited for the development of colon-related complications after closure. The timing of the operation, the age of the patient, the type of colostomy, and the use of primary or delayed skin closure have all been implicated(7-8). Of all these, the timing of the operation is the most controversial. The early closure of a temporary stoma has many attractions. It can reduce hospitalization time and cost, eliminates the need for stoma care by the patient, and abolishes the psychologic, social, and financial burdens of a stoma in an otherwise healthy person(9-11)

Eligibility criteria: Inclusion Criteria:

* age between (10-50)

Exclusion Criteria:

* pathological causes
* deep, open perineal tear
* Severe co-morbid conditions (uncontrolled diabetes, Hypertension)

Primary outcomes:
measure: Early versus late stoma closure after traumatic colorectal injuries
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Taheri PA, Ferrara JJ, Johnson CE, Lamberson KA, Flint LM. A convincing case for primary repair of penetrating colon injuries. Am J Surg. 1993 Jul;166(1):39-44. doi: 10.1016/s0002-9610(05)80579-3.
citation: Todd GJ, Kutcher LM, Markowitz AM. Factors influencing the complications of colostomy closure. Am J Surg. 1979 Jun;137(6):749-51. doi: 10.1016/0002-9610(79)90086-2.
Clinical trial NCT00661479: An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Retinitis Pigmentosa
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.


Eligibility criteria: Inclusion Criteria:

* Retinitis Pigmentosa in both eyes
* Visual acuity between 20/40 to count fingers

Exclusion Criteria:

* Growth of new blood vessels in the eye
* Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
* Any ocular disease that can interfere with diagnosis and or assessment of disease progression
* Significant near-sightedness
* HIV
* Female patients who are pregnant, nursing, or planning pregnancy

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline in Contrast Sensitivity in the Study Eye
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Arlington
country: United States
state: Texas
city: Paris
country: France
city: Tubingen
country: Germany
city: Coimbra
country: Portugal
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03997279: Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii
Official title: Double-blind, Placebo-controlled, Randomized Study for Assesment of the Efficiency and Safety Quadruple Therapy for Helicobacter Pylori Infection With or Without the Addition of Saccharomyces Boulardi Probiotic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori
Saccharomyces boulardi
Eradication therapy
Lead sponsor: Clinical Centre of Serbia
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.

Detailed description: Standard triple therapy for H. pylori infection proved to be insufficiently effective, primarily due to antibiotics resistance.Therefore, the latest Maastricht consensus suggests using bismuth-quadruple or non-bismuth-quadruple therapy, in regions with high clarithromycin resistance. The addition of probiotics with eradication therapy has never become a standard treatment. However, the Maastricht consensus suggest that the addition of probiotics could increase the effectiveness of quadruple therapy.

The study was designed as a prospective, double-blind, randomized, case-control intervention study.

Eligibility criteria: Inclusion Criteria:

* Dyspepsia
* Patients not treated for H. Pylori
* Age of 18-50 years
* Positive urea breath test

Exclusion Criteria:

* Alarm symptoms (anemia, persistent vomiting, hematemesis, dysphagia, significant weight loss, palpable mass in abdomen)
* Gastric cancer
* Immunosuppressive therapy
* Use of acetylsalicylic acid
* Severe renal failure
* Severe liver failure
* Immunodeficiency
* Proven malignant disease
* Penicillin allergy
* Allergy to any component of dietary supplement (Saccharomyces boulardii and Vitamin D)
* Chronic alcoholism
* Pregnancy
* Lactation

Primary outcomes:
measure: Result of urea breath test (Eradication of H.pylori)
timeFrame: baseline to 8 weeks after the introduction of the therapy
Secondary outcomes:
measure: Side effects of eradication therapy
timeFrame: baseline to 8 weeks after the introduction of the therapy
measure: Compliance of eradication therapy
timeFrame: baseline to 8 weeks after the introduction of the therapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00238979: A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
Official title: A 6-month, 1-arm, Open-label Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Renal transplantation, Enteric-coated mycophenolate sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.


Eligibility criteria: Inclusion criteria:

* Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant.
* Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months.
* In a stable condition in terms of graft function.

Exclusion criteria:

* Patients who had taken an investigational drug within four weeks prior to study entry
* History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
* Thrombocytopenia (\<75,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (\<2,500/mm3), and/or hemoglobin \<6.0 g/dL prior to enrollment
* Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen.
Secondary outcomes:
measure: Safety based on renal function within 6 months after medication switch.
measure: Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3
measure: Influence of enteric-coated mycophenolate sodium on the activity of an enzyme at baseline, week 2, month 3
measure: Incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
measure: Graft survival and patient survival 6 months post medication switch.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT05908279: Gait Control in Parkinson Disease
Official title: Flexible Control of Gait in Parkinson Disease: Effect of Task Instruction on the Exploitation of Redundancy in Speed Control.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One group of volunteers with previous diagnosis of Parkinson disease and one group of age and sex matched healthy volunteers.

Brief summary: Previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in Parkinson disease (PD). On the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards maintaining a constant speed. Here the investigators want to better understand why it is altered in PD by measuring the transitions between gait instructed by a metronome, and gait without metronome. The experimental conditions will allow the comparisons between these transitions across PD and healthy groups of volunteers, and assess differences based on statistical and computational modelling. The link with potential freezing episodes will also be studied to assess whether the statistical determinants of gait control in this population can be used as a proxy or predictor of the occurence of freezing episodes.


Eligibility criteria: Inclusion Criteria:

* Patients and volunteers able to walk for 20mins and without other neurological disorders.

Exclusion Criteria:

* Patients or volunteers unable to walk for 20mins and with other neurological disorders.

Primary outcomes:
measure: Stride cadence
timeFrame: Measured during the entire experiment (an average of 4.5 years)
measure: Stride amplitude
timeFrame: Measured during the entire experiment (an average of 4.5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: Université catholique de Louvain
Study officials:
affiliation: Université Catholique de Louvain
name: Frederic Crevecoeur
role: STUDY_DIRECTOR
References:
Clinical trial NCT00482079: A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)
Official title: A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled Dose-Range Finding Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type II
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 743
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.


Eligibility criteria: Inclusion Criteria:

* Age 21 to 70, You are a man or non-pregnant woman

Exclusion Criteria:

* Have a history of type I diabetes
* You are on a weight loss program with ongoing weight loss or taking weight loss medications
* You have a history of minor surgery
* You have received investigational drugs within 8 weeks of study start
* You have hepatitis B or C

Primary outcomes:
measure: To asses the effectiveness of MK0431 compared to placebo
timeFrame: over 12 weeks
Secondary outcomes:
measure: To test the safety and tolerability of MK0431 in patients with type 2 diabetes
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Scott R, Wu M, Sanchez M, Stein P. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 2007 Jan;61(1):171-80. doi: 10.1111/j.1742-1241.2006.01246.x. Epub 2006 Dec 5.
citation: Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.
Clinical trial NCT00249379: Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees
Official title: The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alcohol Dependence
Keywords: Alcohol dependence
Acamprosate(drug)
Drug Court
Probation
Parole
Criminal justice
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-11-07
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 this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).

Detailed description: Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. These programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. However, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole.

Comparison: Alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.

Eligibility criteria: Inclusion Criteria:

* History of alcohol dependence in the year before entering criminal justice supervision
* Currently under criminal justice supervision (drug court, probation, or parole) in central Virginia

Exclusion Criteria:

* Pregnant or nursing a baby
* Known sensitivity to acamprosate
* Elevated serum creatinine level or other evidence of kidney problems
* Symptoms of severe depression or suicidal ideation
* Non-English speaking such that they cannot provide informed consent
* Cognitive impairment such that they cannot provide informed consent

Primary outcomes:
measure: Drinking and Other Drug Use
timeFrame: 12 weeks
measure: Level of Acceptance
timeFrame: 12 weeks
Secondary outcomes:
measure: Retention in Drug Court
timeFrame: 12 weeks
measure: Recidivism Rates
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Medical Center
name: Michael F. Weaver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02715479: A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176
Official title: A Two-way Drug Interaction Study to Evaluate the Effect of BMS-955176 on the Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2016-03-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent
2. Target population: Healthy males and females.
3. Women of child bearing potential (WOCBP) with negative serum pregnancy test
4. Women must not be breastfeeding
5. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

1. History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia
2. History of frequent headaches or acute diarrhoea.
3. Any major surgery within 4 weeks of study drug administration
4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
5. History of allergy to HIV maturation and integrase inhibitors,or related compounds
6. History of smoking

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) for DTG
timeFrame: Days 1 to 5 and days 15 to 21
measure: Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG
timeFrame: Days 1 to 5 and days 15 to 21
measure: Maximum observed plasma concentration (Cmax) for BMS-955176
timeFrame: Days 8-21
measure: Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176
timeFrame: Days 8-21
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: Days 1-21; for SAEs up to 30 days post discontinuation of dosing
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: