louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000336: Selegiline in Outpatient Treatment for Cocaine Dependence - 1
Official title: Safety and Efficacy of Selegiline in Outpatient Treatment for Cocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and clinical safety of selegiline in the treatment of cocaine dependence and to assess neurotoxicity (Magnetic Resonance Imaging, MRI) post-hoc as a possible variable for future stratification in clinical trials.


Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Meets DSM-IV criteria for cocaine. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Primary outcomes:
measure: Urine toxicology for cocaine
measure: Self reports of cocaine and other drug use and craving
measure: Evidence of change in neurotoxicity based on choreoathetoid movement assessments
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01514136: An Investigation of Ostomy Devices
Official title: CP216: An Exploratory Investigation of Convex Ostomy Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Coloplast A/S has developed a new ostomy device in 8 versions.

The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.

The secondary objective is to investigate several performance and safety parameters of the various devices.

The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.

Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.

The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.

Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old
* Have signed the declaration of informed consent
* Have an ileostomy in a concave area
* Have had an ileostomy for at least three months
* Have used convex plates (for convex users) or flat plates (for flat plate users) for the last month
* Be users of 1-piece or 2-piece open ostomy devices
* Have an ileostomy with a diameter of less than 33 mm

Exclusion Criteria:

* Are pregnant or breast-feeding
* Have a double-loop ileostomy
* Have known hypersensitivity or allergy to the devices' component ingredients
* Are receiving/have received radiation treatment and/or chemotherapy within the last 3 months.
* Are receiving/have received local peristomal or systemic steroid treatment within the last month
* Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Primary outcomes:
measure: Degree of Leakage
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02303236: Biological Markers Predicting Exercise Capacity in CF-LVAD Patients.
Official title: Biological Markers Predicting Exercise Capacity in Heart Failure Patients Supported With a Continuous-flow Left Ventricular Assist Device.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Exercise
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable CF-LVAD patients.

Brief summary: Establishing the association between biological markers and exercise capacity in continuous-flow left ventricular assist device patients.

Detailed description: The aim of this study is to investigate if specific biological markers can predict exercise capacity in advanced heart failure patients supported with continuous-flow left ventricular assist device patients.

Eligibility criteria: Inclusion Criteria:

* Stable CF-LVAD patients.

Exclusion Criteria:

* Unstable CF-LVAD patients.

Primary outcomes:
measure: Biological markers
timeFrame: Blood sampling on study day and samples are subsequently stored frozen.
Secondary outcomes:
measure: Exercise capacity
timeFrame: Examination on study day. Patients will only be followed on the day of the study. Exercise testing is performed as the last intervention on the study day.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital Rigshospitalet.
state: Kbh Oe
Study officials:
affiliation: Rigshospitalet, Denmark
name: Finn Gustafsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02160236: Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam
Official title: Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: dexketoprofen trometamol
tenoxicam
postoperative pain
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 90
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: In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.

Detailed description: Lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. Dexketoprofen has been reported to be one of the NSAİDs that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. Tenoxicam is a thienothiazine derivative of the oxicam class of NSAİDs. There are some studies in which NSAİDs have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects

Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* between 18-65 age
* elective lumbar disc surgery

Exclusion Criteria:

* history of gastrointestinal bleeding
* peptic ulcer disease
* bleeding disorders
* history of allergic reactions to NSAİDs
* chronic pain syndrome

Primary outcomes:
measure: analgesic consumption
timeFrame: postoperative 1 day
Secondary outcomes:
measure: visual analog scale
timeFrame: postoperative 1 day
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes Universty Hospital
Study officials:
affiliation: TC Erciyes University
name: nazife küçük, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02750436: A Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks
Official title: A Prospective Randomized Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lead sponsor: Montreal General Hospital
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 40
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: Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. Outcomes examined will include performance times and success rates.


Eligibility criteria: Inclusion Criteria:

* Any consenting patient over 18 years of age, undergoing a diagnostic sacral lateral branch block for suspected sacroiliac joint related pain.

Exclusion Criteria:

* Inability to consent, iodine or lidocaine allergy, pregnancy, coagulopathy (as defined by an international normalized ratio over 1.4, platelets under 100,000, or a documented bleeding disorder) and inability to visualize the target areas necessary for sensory testing (posterior superior iliac spine, dorsal aspect of SIJ) under ultrasound guidance.

Primary outcomes:
measure: Performance time
timeFrame: Duration of procedure (less than 20 minutes)
Secondary outcomes:
measure: Change in pain numerical rating score from baseline
timeFrame: Baseline and 20 minutes after procedure
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Roderick J Finlayson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03510936: Gut Microbiome Associated Study of Shanghai Infants With Jaundice
Official title: Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Microbiome
Keywords: Probiotics
Gut Microbiome
Infants
Jaundice
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.

Detailed description: This study aims to examin the impact of probiotics administration during the process of infants jaundice treatment and recovery phase.the recovery phase.Birth,7 days,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants with jaundice.

Eligibility criteria: Inclusion Criteria:

* Newborns with jaundice treated with blue light phototherapy

Exclusion Criteria:

* Gestational weeks \<37 Birth weight \<2500g or ≥4000g History of asphyxia anoxia at birth With infectious diseases treated with antibiotic With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases

Primary outcomes:
measure: change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA
timeFrame: 42 days
Secondary outcomes:
measure: change from birth on gut microbiome at 7 days by 16S rRNA
timeFrame: 7 days
measure: change from birth and 7 days on gut microbiome at 14 days by 16S rRNA
timeFrame: 14 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Huanlong Qin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02210936: SCOSI-M: Preventing Prescription Drug Problems
Official title: Preventing Prescription Drug Problems: A Pilot Military Opioid Safety Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prescription Drug Problems
Lead sponsor: Brandeis University
Sponsor class: OTHER
Collaborators: name: University of South Carolina
name: Medical University of South Carolina
name: Moncrief Army Community Hospital
name: William Jennings Bryan Dorn VA Medical Center
First posted: 2014-08-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Brandeis University and University of South Carolina (USC) have joined together to develop the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic detailing (medical education) intervention for physicians and evaluate its effectiveness in a pilot study. The goal of the intervention is to increase the use of safe prescribing and prescription monitoring practices among primary care physicians. The research team will design and pilot an educational intervention for physicians who treat military personnel, veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to prevent the onset or progression of prescription drug problems among Iraq and Afghanistan veterans, military members, and their families who are at high risk for developing problems if their treatment involves long-term use of an opioid.


Eligibility criteria: Inclusion Criteria:

1. a physician within one of the 3 practice environments;
2. typically prescribes Schedule II opioids to 10 or more non-cancer pain patients each month;
3. if community office-based, a substantial number of patients must have TRICARE (e.g., 20%); and d) willing to provide written consent for data collection and release of own SCRIPTS data.

Exclusion Criteria:

1. non-physician providers who report data to the SCRIPTS (dentist, veterinarians, nurses),
2. surgeons, pediatricians, or physicians predominately treating pain in cancer or surgical patients, and,
3. not eligible to register as authorized SCRIPTS user.

Primary outcomes:
measure: Use of SCRIPTS
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Brandeis University
state: Massachusetts
Study officials:
References:
citation: Larson MJ, Browne C, Nikitin RV, Wooten NR, Ball S, Adams RS, Barth K. Physicians report adopting safer opioid prescribing behaviors after academic detailing intervention. Subst Abus. 2018;39(2):218-224. doi: 10.1080/08897077.2018.1449175. Epub 2018 May 4.
Clinical trial NCT04618536: Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmer
Official title: Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sunscreen Persistence
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prolonged sunlight exposure in swimming athletes can cause various changes in the skin; among them is sunburn. The use of sunscreen can reduce sunburn effectively. However, various types of physical activity that can trigger sweating, friction, washing with water, or sun exposure after sunscreen use can interfere with its effectiveness in the form of a decreased SPF level. The purpose of this study is to determine and compare the persistence of organic and inorganic sun protection factor 30 (SPF 30) sunscreens after 1.5 hours of swimming.


Eligibility criteria: Inclusion Criteria:

* Female or male swimming athletes aged 18-40 years.
* Practice swimming at least 3 times a week with a duration of 1.5-2 hours per practice in the morning or afternoon.
* Willing to be the subject of research by signing the consent.
* Do not have skin diseases.
* Do not have a history of allergies to sunscreens.

Exclusion Criteria:

* Existence of skin lesion in the test area.
* In the treatment of phototherapy.
* Using drugs with photosensitivity side effects.
* History of skin malignancy, history of photosensitivity reactions or history of disease affected by UV rays.
* Exposure to direct sunlight to the test area 24 hours before the study and during the study period.
* Absence of erythema response 24 hours after the radiation test.
* Erythema occurs in the entire test area box 24 hours after the radiation test.

Primary outcomes:
measure: SPF change after swimming for 1.5 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Inorganic sunscreen SPF
timeFrame: 24 hours
measure: Organic sunscreen SPF
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Karin Rachmani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Shannaz N Yusharyahya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Adhimukti T Sampurna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Respati W Ranakusuma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Sandra Widaty, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831036: The Impact of Physical Exercise on Navigation Performance in Soldier
Official title: The Impact of Physical Exercise on Navigation Performance in Soldier
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spatial Learning
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Bar-Ilan University, Israel
First posted: 2016-07-13
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 20 healthy man, 10 in trial group and 10 in control group (randomly divided) will participate in the experiment on order to evaluate if improvement in physical fitness influences spatial learning in humans.

Detailed description: subjects in both groups will perform 4 sets of VO2max test and spatial orientation test with a month between them (total 3 month).

in addition, subjects in trial group will follow a training program throughout the trial (running on treadmill 3 times a week), suited according to their result in the first VO2max test.

in each set VO2max test will be perform before spatial orientation test , in order to evaluated the subject's aerobic fitness. the spatial orientation test is composed of 5 following days in which the subject has 3 attempts to arrive to a destination in xbox one controller using a virtual glasses (Oculus Rift DK2). each attempt duration is 2 min.

Eligibility criteria: Inclusion Criteria:

* civilian healthy man, aged 18-30
* without any neurological or psychiatric disorder
* not wearing eyeglasses

Exclusion Criteria:

* athletes or trained man (for both groups)

Primary outcomes:
measure: spatial learning (composite)
timeFrame: 20 experimental days for each participant
Secondary outcomes:
measure: maximal aerobic capacity
timeFrame: 4 experimental days for each participant
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Haggai Schermann, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01506336: Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
Official title: A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastro Intestinal Stromal Tumor
Keywords: GIST
resistant
imatinib
gastro intestinal stromal tumor resistant to imatinib
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.


Eligibility criteria: Inclusion Criteria:

1. Histological proven, metastatic, or locally advanced and non-operable GIST
2. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
3. C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
4. Patients resistant to imatinib at dose of 400 mg/day

Exclusion Criteria:

1. Patient treated for a cancer other than GIST cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
2. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

Primary outcomes:
measure: overall progression free survival
timeFrame: up to 36 weeks
Secondary outcomes:
measure: overall survival
timeFrame: up to 36 weeks
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institute Gustave Roussy (IGR)
Study officials:
affiliation: Institut Gustave Roussy, Villejuif, France
name: Axel Le Cesne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adenis A, Blay JY, Bui-Nguyen B, Bouche O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blesius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial. Ann Oncol. 2014 Sep;25(9):1762-1769. doi: 10.1093/annonc/mdu237. Epub 2014 Jul 25.