louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00259571: Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.
Official title: Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte ("Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Keywords: remission
mesalazin
non-inferiority study
relapse
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Dietmar Hopp Stiftung
First posted: 2005-11-29
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis.

The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.


Eligibility criteria: Inclusion Criteria:

* diagnosis of ulcerative colitis in remission (CAI 3 or less)
* signed letter of content
* no steroids or immunosupressants in the last 6 weeks
* at least 5 relapses in the last 3 years
* last relapse was 8 months ago or less
* complete colonoscopy at entry

Exclusion Criteria:

* pregnancy or breast feeding
* steroids or immunosuppressants
* acute episode of UC
* condition after complete or partial colektomy
* known intolerance to mesalazin
* severe medical disease other than colitis

Primary outcomes:
measure: rate of relapses
measure: relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days
Secondary outcomes:
measure: time to the first relapse
measure: amount of relapses per year
measure: endoscopic index
measure: histolgical score
measure: life quality
measure: side effects
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Medical Hospital - University of Heidelberg
Study officials:
affiliation: Heidelberg University
name: Wolfgang Stremmel, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R. Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Gut. 2005 Jul;54(7):966-71. doi: 10.1136/gut.2004.052316.
Clinical trial NCT02591888: Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling
Official title: The Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling for Stress Urinary Incontinence: A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Liposomal bupivacaine or placebo will be administered at the end of a transobturator midurethral sling to determine if there is a difference in a patient's perceived postoperative pain.

Detailed description: The investigators aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain from placement of transobturator slings for the treatment of stress urinary incontinence.

Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years of age
* Planning for outpatient surgical treatment of SUI with placement of a transobturator suburethral sling under general anesthesia

Exclusion Criteria:

* Pregnant or nursing
* Allergy to bupivacaine
* History of drug/alcohol abuse
* Severe cardiovascular, hepatic, renal disease, or neurological impairment°
* Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
* Contraindication to:
* acetaminophen
* oxycodone
* non-steroidal anti-inflammatory drugs (NSAID)
* Administration of an investigational drug within 30 days before study
* Chronic pain syndromes
* Daily NSAID/opioid use
* Patients having concomitant procedures or not undergoing general anesthesia
* Patients who require a concomitant anterior repair or urethrocele repair will not be excluded as this requires the same dissection in the anterior vaginal wall.

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 4 hours after being discharged home
Secondary outcomes:
measure: Likert scale to rate their level of satisfaction with their postoperative pain control.
timeFrame: At 1 and 2 weeks postoperatively
Other outcomes:
measure: VAS to rate their level of satisfaction with their postoperative pain control.
timeFrame: At 1 & 2 weeks postoperatively
Locations:
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Catrina C Crisp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03175588: Comparison of Effects of Interactive Video Games in the Elderly
Official title: Comparison of Effects of Interactive Video Games and Activity Based Approaches on Mobility and General Well Being in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Rehabilitation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be three groups in this study. Two intervention and one control gruop to be compared after the intervention.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the effectiveness of interactive video-games on mobility and wellbeing and to compare them with activity-based approaches in geriatric population.

100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Persons will be placed in the study groups in consideration of their interests. One group will be included in Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation, and video-games will run for 30 minutes two days a week for 8 weeks. The other group will participate a program consisting of various physical activities for the same duration; The results of both groups will be compared with a control group.

Detailed description: 100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Persons will be placed in the study groups in consideration of their interests. One group will be included in Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation, and video-games will run for 30 minutes two days a week for 8 weeks. The other group will participate a program consisting of various physical activities for the same duration; The results of both groups will be compared with a control group.

Eligibility criteria: Inclusion Criteria:

* mini mental test score abowe 21 age between 65 and 85

Exclusion Criteria:

neurological disorders orthopedical problems

-

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 5 minute
Secondary outcomes:
measure: 10-meter walking test
timeFrame: 3 minute
measure: WHQOL-Bref
timeFrame: 15 minute
measure: Hamilton Depression Scale
timeFrame: 15 minute
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahcelievler Community dwelling
Study officials:
affiliation: Istanbul University
name: Arzu Razak Ozdincler, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04411888: Pulmonary Embolism Prognosis Model
Official title: Observation Study of Clinical Manifestation and Outcome in Chinese Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients diagnosed as pulmonary embolism who meet the inclusion criteria above.

Brief summary: The purpose of this study is to analyze the clinical manifestations, imaging features, and prognosis-related factors of pulmonary embolism, and to explore the prognosis risk assessment model for Chinese patients

Detailed description: Patients with pulmonary embolism and aged 18 years or older were enrolled in this study.Patient demographic characteristics((age, sex, department, diagnosis, ), basic vital signs, symptoms at their admissions (hemoptysis, dyspnea, chest pain, syncope), laboratory examinations (blood lab routines, blood gas, liver and kidney function, myocardial marker), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT, CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were collected by reviewing the cases. The prognostic information was collected by telephone follow-up. The follow-up end point was June 2024.

Eligibility criteria: Inclusion Criteria:

Aged 18 years or older. Discharged with the diagnosis of PE from Peking Union Medical College Hospital.

Exclusion Criteria:

Diagnosed PE by other health care facility or transferred from other health care facility .

Without important follow-up data.

Primary outcomes:
measure: Patient survival time
timeFrame: Through study completion, an average of 4 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Juhong Shi, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT02168088: Molecular Autopsy Study
Official title: Molecular Autopsy for Sudden Cardiovascular Death
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sudden Unexplained Death
Keywords: Sudden unexplained death
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 100
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is limited to cases of sudden unexplained death in San Diego County and their living, biologically-related family members.

Brief summary: This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death.

Detailed description: This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death, initially in San Diego County with plans to expand nationally and internationally as funding allows. Genetic testing of the index subjects and their parents (or other biological family members if parents are not available) will be assessed for potential heritable causes of sudden death. By combining the wide catchment base of the San Diego Medical Examiner's Office, sequencing expertise of SD-based collaborators, computing power of the San Diego Supercomputer Center and in-house and external genomic analytics, the Scripps Translational Science Institute aims to provide a more complete characterization and understanding of the genetic causes of sudden death. Ultimately, findings from this study will be utilized to identify previously unrecognized mechanism of sudden death allowing for the development of preventative screening programs and potentially life-saving interventions.

Eligibility criteria: Inclusion Criteria:

* Index case age between birth - 45 years
* Clinical presentation of sudden / unexplained death (believed to be cardiac in nature OR secondary to a massive unprovoked pulmonary embolism with no prior diagnosis of prothrombotic disease)

Exclusion Criteria:

* Premature death secondary to murder, suicide or external causal event
* Premature death thought secondary to known chronic comorbid medical condition
* Premature death thought secondary to end-organ failure (kidney, liver, lung) other than heart
* Previously diagnosed with hypertrophic cardiomyopathy (HCM)
* Prior myocardial infarction (regardless of stenting or bypass)
* Prior cerebrovascular accident (stroke or TIA)
* History of open heart surgery (for any reason)
* History of severe, untreated hypertensive heart disease
* History of illicit drug use
* History of heavy alcohol abuse
* History of severe pulmonary disease
* History of morbid obesity

Primary outcomes:
measure: Heritable causes of sudden death
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Translational Science Institute
state: California
Study officials:
References:
Clinical trial NCT00328588: LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Cancer of Lung
Cancer of the Lung
Non-Small Cell Lung Carcinoma
Carcinoma, Non-Small Cell Lung
Keywords: Treatment Efficacy
Treatment Effectiveness
Disease Management
Treatment
Safety
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-05-22
Enrollment: 37
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: A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer.
* Prior chemotherapy regimen(s) for lung cancer

Exclusion Criteria:

* History of other malignancy in the last 5 years
* Major surgery within the past 21 days

Primary outcomes:
measure: Tumor response rate (CR+PR)
timeFrame: In first 6 cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Chomutov
country: Czech Republic
city: Novi Jicin
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Grosshansdorf
country: Germany
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04709588: Hydrolyzed Collagen Combined With Djulis and Green Caviar Improve Skin Condition
Official title: Hydrolyzed Collagen Combined With Djulis and Green Caviar Improve Skin Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Collagen combined with djulis and green caviar improve skin condition

Detailed description: Using collagen drinks combined fish collagen with djulis, and green caviar to improve skin condition.

Eligibility criteria: Inclusion Criteria:

1. Dry skin
2. Rough skin
3. Large pores
4. Dark yellow complexion
5. Sagging skin

Exclusion Criteria:

1. Skin disorders
2. Liver diseases
3. Kidney diseases
4. Allergy to cosmetics, drugs, or foods
5. Pregnant and lactating women
6. People who had any cosmetic procedures before 4 weeks of the study
7. Area of facial spot over 3 cm2
8. Vegan
9. People who took collagen supplements in the past 3 months.

Primary outcomes:
measure: skin moisture
timeFrame: subjects drank 50 ml every night for 28 days
measure: skin elasticity
timeFrame: subjects drank 50 ml every night for 28 days
measure: skin gloss
timeFrame: subjects drank 50 ml every night for 28 days
measure: skin spot
timeFrame: subjects drank 50 ml every night for 28 days
measure: skin wrinkle
timeFrame: subjects drank 50 ml every night for 28 days
measure: skin roughness
timeFrame: subjects drank 50 ml every night for 28 days
measure: skin smoothness
timeFrame: subjects drank 50 ml every night for 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Research & Design Center, TCI CO., Ltd
Study officials:
affiliation: Research & Design Center, TCI CO., Ltd
name: Chi Fu Chiang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002088: Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial
Official title: Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhea
HIV Infections
Keywords: Diarrhea
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Saccharomyces
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of Saccharomyces boulardii (a nonpathogenic yeast) in producing a significant reduction in diarrheal symptoms in HIV-infected patients with chronic diarrhea.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiviral medication for HIV infection.

Patients must have:

* Documented HIV infection.
* Chronic diarrhea (for at least 1 month) that is either a manifestation or complication of documented HIV infection.
* Had a stool culture (Salmonella, Shigella, Campylobacter, and Clostridium difficile) and stool analysis for ova and parasite (O/P X 3) within the past 2 months.
* Failed antimicrobial treatment for diarrhea OR received no prior antimicrobials for stool pathogens because stool cultures were negative.

Patients who are on antiviral medications for HIV infection must have received such medication for at least 2 weeks and must remain on stable dose for weeks 1 and 2 of study.

Prior Medication:

Allowed:

* Prior antiviral medication for HIV infection (if on such medication, must have received it for at least 2 weeks).
* Standard antimicrobial therapy for a documented positive gastrointestinal pathogen.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Gastrointestinal medications that cause diarrhea (e.g., magnesium-containing antacids, lactulose).
* Maintenance antifungal medication for life-threatening fungal infections (other than fluconazole \<= 100 mg/day).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Madison Clinic
state: Washington
Study officials:
name: Surawicz CM
role: STUDY_CHAIR
References:
citation: McFarland LV, Surawicz CM, Greenberg RN, Fekety R, Elmer GW, Moyer KA, Melcher SA, Bowen KE, Cox JL, Noorani Z, et al. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. JAMA. 1994 Jun 22-29;271(24):1913-8.
Clinical trial NCT04639388: Understanding of Psychotic Disorders in Children With 22q11.2DS
Official title: Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 22q11.2 Deletion Syndrome
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric study with two parallel groups
Primary purpose: BASIC_SCIENCE

Brief summary: The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome

Detailed description: 22q11.2DS is one of the most common microdeletion syndromes (1 / 2000-1 / 4000 births) and one of the most robust genetic risk factors for schizophrenia (1 to 2% of cases). Reciprocally, approximately 30% of patients with 22q11.2DS will develop psychotic symptoms in adolescence or early adulthood. It is now well established that children and adults with 22q11.2DS have lower social skills than developing youth. These social dysfunctions could be partly underpinned by alterations in social cognitive processes, and could also be linked to the emergence of psychotic signs or even schizophrenia. However, to our knowledge, no study has investigated the existence of behavioral prodromal signs during the onset of psychotic signs in children with 22q11.2DS. In addition, the origin of social cognitive processes remains to this day little explored.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of 22q11.2 deletion syndrome or no developmental disease
* Aged from 4 to 13 years old
* French language

Exclusion Criteria:

* Diagnosis of intellectual deficiency according to DSM 5 criteria
* Drug prescribed for somatic condition that could influence cerebral functioning

Primary outcomes:
measure: The Screen for child Anxiety Related Emotional Disorders (SCARED)
timeFrame: Day 1
measure: facial expression recognition task
timeFrame: Day 1
Secondary outcomes:
measure: Sustained hearing attention test (Tea-Ch battery)
timeFrame: Day 1
measure: Rey's Tangled Lines Test
timeFrame: Day 1
measure: NEPSY II battery
timeFrame: Day 1
measure: Mean reaction time
timeFrame: Day 1
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Vinatier
state: Rhone Alpes
Study officials:
affiliation: CH LE VINATIER
name: Marie-Noëlle BABINET
role: PRINCIPAL_INVESTIGATOR
References: