louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00568087: N-acetylcysteine in Alcohol Dependence
Official title: N-acetylcysteine in Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alcoholism
Keywords: N-acetylcysteine
Alcoholism
Treatment
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Minnesota Veterans Medical Research and Education Foundation
First posted: 2007-12-05
Enrollment: 46
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: The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.

Detailed description: The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.

Eligibility criteria: Inclusion Criteria:

* age 18 - 65
* alcohol dependence by DSM-IV
* heavy drinking at least 4 times in the past month
* able to provide informed consent

Exclusion Criteria:

* current drug abuse or dependence by DSM-IV criteria (except nicotine or cannabis)
* current psychotic disorders, bipolar disorders, or cognitive disorders
* current suicidal or homicidal ideation
* positive illicit drug screen (except cannabis)
* Clinical Institute Withdrawal Assessment for Alcohol, Revised \>15
* initiation of individual therapy or counseling in the past 3 months
* changes in doses of psychiatric medications in the past 3 months
* clinically unstable cardiac, hepatic, renal, neurologic, or pulmonary disease
* current use of naltrexone, disulfiram or acamprosate
* pregnant or nursing women, or inadequate birth control methods in women of childbearing potential

Primary outcomes:
measure: Alcohol Consumption (Percentage of Heavy Drinking Days)
timeFrame: The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.
Secondary outcomes:
measure: The Penn Alcohol Craving Scale
timeFrame: The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.
measure: The Obsessive Compulsive Drinking Scale
timeFrame: The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.
measure: Liver Function Tests
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Gihyun Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00934687: Botulinum Toxin for the Treatment of Depression
Official title: Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: depression
depressive
botulinum
botox
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
First posted: 2009-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Depression is frequently accompanied by a specific sad facial expression. This expression is in part mediated by the same muscle activity that produces frown lines. Based on the assumption that there is a positive feedback between depressed mood and the correspondent facial muscle activity (facial feedback) the investigators will conduct a randomized controlled pilot study in which the investigators will apply a classical cosmetic treatment of frown lines with injections of botulinum toxin to depressed patients who did not sufficiently respond to antidepressant medication. The investigators hypothesize that this treatment will contribute to the amelioration of depressive symptoms in these patients. This hypothesis is supported by a previous open case series in which remission of depression was reported after such treatment (Finzi and Wasserman, 2006).


Eligibility criteria: Inclusion Criteria:

* Mild to moderate depression (Ham-D \>=15)
* Therapy with one antidepressant for at least four weeks
* at least moderate frown line

Exclusion Criteria:

* Bipolar depression
* Psychiatric comorbidity
* Severe somatic comorbidity
* Pregnancy
* Peculiarities at the injection site
* Psychiatric medication other than one antidepressant
* Specific psychotherapy
* Previous application of botulinum toxin
* Medication interfering with botulinum toxin

Primary outcomes:
measure: Response rate (reduction in Ham-D score by >30% compared to baseline)
timeFrame: six weeks
Secondary outcomes:
measure: Remission rate (number of patients with HAM-D score < 8)
timeFrame: six weeks
measure: Time to response (20% reduction of HAM-D score compared to baseline)
timeFrame: two, four, or six weeks
measure: response by self rating (BDI)
timeFrame: six weeks
measure: need for additional treatment
timeFrame: eight weeks, twelve weeks, or sixteen weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy
city: Basel
country: Switzerland
facility: Psychiatry Hospital of the University of Basel, Basel, Switzerland
state: Basel Town
Study officials:
affiliation: Asklepios Klinik Nord - Ochsenzoll, Hamburg/D
name: Marc A Wollmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical School HannoverPsychiatry, Social Psychiatry and Psychotherapy, Hannover, Germany
name: Tillmann HC Krüger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02926287: Ambulatory Surgery for Urogenital Prolapse : a Pilot Study
Official title: Ambulatory Surgery for Urogenital Prolapse : a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse
Keywords: prolapse surgery
ambulatory surgery
Lead sponsor: Clinique Beau Soleil
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study.

Secondary objectives are AS rate in the overall population and reasons for ineligibility or failure of ambulatory surgery.

This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS.

A randomized control study will follow PCAP study.

Detailed description: The prolapse surgery will be performed in 13% of women. Improved surgical and anesthetic techniques available makes this surgery to ambulatory care, while the latter is only slightly conducted in France.

Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study.

Secondary objectives are AS rate in the overall population and reasons for ineligibility or failure of ambulatory surgery.

This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS.

A randomized control study will follow PCAP study.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Planned POP surgery
* Valid social insurance
* French spoken and written
* Informed consent signed
* No exclusion criteria

Exclusion Criteria:

* Refuse participation to study
* Pregnant or lactating woman
* Vulnerable people (Article L 1121-6 of the french code of public health)
* Major subject to legal protection or unable to consent (Article 1121-8 of the french code of public health )
* Participation in another protocol for less than 3 months
* Patient not presenting all the inclusion criteria.

Primary outcomes:
measure: Success rate of ambulatory surgery in patient operated for urogenital prolapse
timeFrame: After the 2 years of recruitment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinique Beau Soleil
name: Christophe Courtieu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02334787: A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects
Official title: A Single-center, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Assess the Safety and Pharmacokinetics of OPA-15406 Ointment in Healthy Adult Male Subjects (Phase 1 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-08
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or 3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* BMI = Body weight (kg) / \[Height (m)\]2: at least 18.5 and less than 25.0
* Judged by the investigator or subinvestigator to be healthy based on test results at screening and prior to administration on Day 1 of the treatment period

Exclusion Criteria:

* Findings (sunburn, abrasions, tattoos, etc) on the back that affect the evaluation of the safety of the skin
* Judged by the investigator or subinvestigator as inappropriate to participate in this trial for any other reasons

Primary outcomes:
measure: Cmax of OPA-15406 in a Single Administration Period
timeFrame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr
measure: Cmax of OPA-15406 in the Multiple Administration Period
timeFrame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14
Secondary outcomes:
measure: AUC12h of OPA-15406 in a Single Administration Period
timeFrame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs
measure: AUC12h of OPA-15406 in the Multiple Administration Period
timeFrame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14
Other outcomes:
Locations:
city: Kanto Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Hiroaki Ono, Mr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01812733: Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives
Official title: An Observational Study of Quality of Life, Resource Use and Costs Associated With Treatment of Severe Pain - a Comparison of a Combination of Oxycodone and Naloxone (Targiniq) Versus Oxycodone and Laxatives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Opioid Induced Constipation
Lead sponsor: Mundipharma AB
Sponsor class: INDUSTRY
First posted: 2013-03-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients have severe pain treated with opioids and will be enrolled at different clinics in Sweden

Brief summary: The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with Targiniq.


Eligibility criteria: Inclusion criteria:

* Male or non-pregnant female ≥18 years of age
* Malignant or non-malignant opioid sensitive pain
* Must sign an informed consent form (ICF)
* Must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts)
* Use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect
* BFI ≥30 and state a discomfort caused by the constipation at screening
* Ability to answer the patient questionnaires and have an estimated overall life expectancy of at least six (6) months

Exclusion criteria:

* History of, or on-going, abuse of alcohol and/or drugs
* Inability to read and understand written instructions, ICF or questionnaires
* Constipation not related to opioid use
* Unsuitable patient for other reason(s) in the opinion of the investigator
* Inpatients, if admission and/or discharge is expected during study period

Primary outcomes:
measure: Quality of Life
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Rehabiliteringsmedicinska kliniken
Study officials:
References:
Clinical trial NCT02111733: Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?
Official title: Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 43
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Evaluation of High sensibility troponin levels modification by hemodialysis in terminal renal failure patient at Sherbrooke University Hospital Center as determined by serial measurements. Verification of potential effects of these levels and their variation as predictors of cardiovascular outcomes and events at 6 and 12 months.

Detailed description: Recruiting of hemodialysis patients of the nephrology renal supplementation clinics at Sherbrooke University Hospital Center to measure three blood level of high-sensibility troponins before and after standard dialysis. Verification on the variation of these levels after dialysis. Follow-up at 6 and 12 months of the patient for Cardiovascular events and death and verification of a possible predictive value of troponin blood levels for these events.

Eligibility criteria: Inclusion Criteria:

* over 50 years, no symptoms, over 1 months of hemodialysis

Exclusion Criteria:

* 1 or more in the last month; Acute coronary syndrome, Heart failure decompensated, Myo or Pericarditis, Pulmonary embolism, Sepsis/shock, Stroke or transient ischemic attack, Malignant high blood pressure, Arrythmia, electrical cardio-version, major trauma, significant burnings (\>25%), Chemotherapy, Cardiovascular surgery, percutaneous angio-intervention,
* Chronic systemic disease (sarcoidosis, amyloidosis, LED, Etc.)

Primary outcomes:
measure: High sensibility troponins T blood level variation
timeFrame: 1 week
Secondary outcomes:
measure: Prognostic value of high sensibility troponins T blood level variation
timeFrame: at 6 and 12 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Sherbrooke
country: Canada
facility: University of Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Michel Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01847833: Advanced MRI Applications Development
Official title: Advanced MRI Applications Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Tumors
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-05-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with brain tumors or tumors affecting the brain.

Brief summary: The goals of this study are to:

1. To improve upon and develop new innovative magnetic resonance imaging techniques that refine image quality and enhance performance. Improvements in these areas will have positive implications for medical diagnosis and treatment.
2. To correlate MRI images with underlying disease pathophysiology in order to ensure that imaging accurately reflects the disease process.


Eligibility criteria: Inclusion Criteria:

* Brain Tumor

Exclusion Criteria:

* Unable to undergo MRI

Primary outcomes:
measure: patients alive and progression free at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
References:
Clinical trial NCT00663533: VAS-2 Vasectomy With the Vax-X
Official title: Vasectomy With the Vas-X, a Simple, Minimally Invasive Device for Male Sterilization: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Vasectomy
Contraception
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 10
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to study an experimental vasectomy device called the Vas-X. This is an experimental study of this new approach to vasectomy.

Detailed description: The Vas-X works by stripping the lining of the vas deferens, the tube that sperm pass through during ejaculation. It is used in a way very similar to routine vasectomy, however, in a routine vasectomy, the vas is burned with an electrical device. With the Vas-X, there is no burning. The investigators are testing the Vas-X to determine whether it will offer a better way of performing a vasectomy.

The investigators will conduct this study at the University of Washington Medical Center, Seattle.

Eligibility criteria: Inclusion Criteria:

* healthy male with normal physical findings
* normal testicular volume (15-30mL)
* detectable sperm in ejaculates

Exclusion Criteria:

* Men with past history of

  * hypertension
  * significant cardiovascular
  * thromboembolic disorders
  * renal (including undiagnosed urinary tract bleeding)
  * hepatic, prostatic and testicular disease
  * prior vasectomy or scrotal surgery
  * infertility
* Men with a past history of drug abuse will also be excluded.

Primary outcomes:
measure: absence of sperm in ejaculated semen 6 months after vasectomy
timeFrame: 6-months
Secondary outcomes:
measure: any side effects as well as degree of occlusion of the resected segment of vas deferens
timeFrame: 6-months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: John Amory
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amory JK, Jessen JW, Muller C, Berger RE. Vasectomy by epithelial curettage without suture or cautery: a pilot study in humans. Asian J Androl. 2010 May;12(3):315-21. doi: 10.1038/aja.2009.94. Epub 2010 Feb 15.
Clinical trial NCT03901833: LIFT: Telemedicine Breastfeeding Support
Official title: Telemedicine Breastfeeding Support Following Late Preterm Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-04-03
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The central hypothesis guiding this project is that tailored breastfeeding support, that leverages easily accessible telemedicine technologies, can improve breastfeeding outcomes among late preterm dyads. The long-term goals of this project are to improve maternal and child health and reduce health disparities by designing and implementing evidence-based interventions to improve breastfeeding outcomes for this challenging patient population. This study seeks to identify lactation support practices that improve breastfeeding duration and to test the effect of telemedicine breastfeeding support on breastfeeding duration, among the nearly one in ten mothers who deliver late preterm (34-37 6/7 weeks), as this subpopulation of mothers faces the highest rates of premature breastfeeding cessation


Eligibility criteria: Inclusion Criteria:

* maternal age 18-49 years
* late preterm delivery (34-37 6/7 weeks)
* enrollment up to 1 week postpartum
* breastfeeding initiated
* access to a smartphone, tablet, or laptop computer in their home

Exclusion Criteria:

* incarceration
* inability to communicate in English
* infant with medical condition compromising breastfeeding (e.g. cleft lip and/or palate).

Primary outcomes:
measure: Experience
timeFrame: One month post-enrollment
Secondary outcomes:
measure: Time to cessation
timeFrame: Monthly up to 12 months
measure: Exclusive breastfeeding cessation
timeFrame: Monthly up to 12 months
measure: Breastfeeding at 3 months
timeFrame: 3 months
measure: Exclusive breastfeeding
timeFrame: 3 months
measure: Individual satisfaction questions
timeFrame: 1 month post enrollment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Laura Kair, MD
role: PRINCIPAL_INVESTIGATOR
References: