louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00631605: Studies of Neuroendocrine and Energy Metabolism in Patients With Eating Disorders
Official title: Studies of Neuroendocrine and Energy Metabolism in Patients With Eating Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Bulimia Nervosa
Keywords: eating disorders
ghrelin
leptin
BIA
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-03-10
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with eating disorders and normal controls

Brief summary: This study aims to investigate neuroendocrine, autonomic functioning, and energy metabolism in patients with eating disorder and their relationships with psychopathology of eating disorders (eating patterns, depression, and personality) in these patients.

Detailed description: The study subjects include female patients with DSM-IV diagnosis of AN (n = 30), BN (n = 60) and age-controled normal subjects (n = 30). They will receive a clinical interview and are asked to complete several self-administered questionnaires which included eating-related questionnaires, general psychological functioning scales and personality scales. After overnight fast, each subject undergoes a blood sample collection for neuroendocrine examination, body composition examination using BIA method, basal metabolic rate measurement by indirect calorimetry, and ECG in the morning between 0800 and 0900. Clinical patients would be asked to repeat filling the self-rating scales, weight and body fat measurement, as well as blood drawing again 2 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Subjects who fulfilled DSM-IV diagnosis of anorexia nervosa or bulimia nervosa
* Normal controls

Exclusion Criteria:

* Any major psychiatric disorders
* Use of psychoactive medications
* Drug and alcohol abuse
* Medical problems (cardiovascular condition and endocrine disorders)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Mei-Chih Tseng, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00535405: A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
Official title: A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: High Cholesterol
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Merck Shering-Plough JV Study
First posted: 2007-09-26
Enrollment: 1289
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.


Eligibility criteria: Inclusion Criteria:

* Patient has a cholesterol level of 130 mg/dL or greater
* Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
* Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Exclusion Criteria:

* Patient weighs less than 100 lbs
* Patient has an allergy to ezetimibe, simvastatin or atorvastatin

Primary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12
timeFrame: 12 weeks
measure: Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
timeFrame: 12 Weeks
measure: Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12
timeFrame: 12 Weeks
measure: Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12
timeFrame: 12 Weeks
measure: Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
timeFrame: 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051.
Clinical trial NCT04404205: The Effect of Cochlear Implant on Postural Control
Official title: The Effect of Cochlear Implant on Postural Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Implant
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had cochlear implantation in our hospital will be invited to join the study.

Brief summary: Some patients are having balance problems after cochlear implant surgery. There are contradictory reports about the effect of the implant on postural control. While the cochlear implant is working, an electrical current is continuously stimulating the cochlear nerve which is in close proximity with vestibular ganglion and nerve. This stimulation may contribute to vestibular signals to the central system. The aim of the study is to investigate if this stimulation has any effect on postural control.

Detailed description: Adult patients who had unilateral cochlear implantation will be included. Postural stability measurements will be done by the Biodex Balance System. Three preprogrammed main tests and their 9 subtests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).

Eligibility criteria: Inclusion Criteria:

* Patients who had cochlear implant surgery before

Exclusion Criteria:

* Bilateral Cochlear implants
* Neurologic disease
* Communication problem
* Additional disability

Primary outcomes:
measure: Deviation of center of gravity(angle)
timeFrame: 3-6 months
measure: postural sway velocity(angle/sec)
timeFrame: 3-6 months
measure: Sensory Integration Test(the mean absolute deviation of the patient's average position during a test)
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fazıl N Ardıç, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01116505: Treatment of Screen-detected Celiac Disease
Official title: Treatment of Screen-detected Celiac Disease in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: Celiac disease
Endomysial antibodies
Gluten-free diet
Screen-detected
Asymptomatic
Bone mineral density
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.

Detailed description: Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.

Eligibility criteria: Inclusion Criteria:

* Positive endomysial antibodies
* Adults

Exclusion Criteria:

* Previous celiac disease diagnosis
* Significant clinical symptoms
* Suspicion of any serious celiac disease-associated complication
* Suspected or diagnosed severe illness other than celiac disease
* Consuming oral corticosteroids or immune suppressants
* Marked laboratory abnormalities

Primary outcomes:
measure: Small-bowel mucosal morphology and inflammation
timeFrame: One year
Secondary outcomes:
measure: Endomysial antibodies
timeFrame: one year
measure: Tissue transglutaminase antibodies
timeFrame: one year
measure: Antibodies to deamidated gliadin
timeFrame: one year
measure: Intestinal tissue transglutaminase-specific IgA deposits
timeFrame: one year
measure: Bone mineral density
timeFrame: one year
measure: Body composition
timeFrame: one year
measure: Health-related quality of life
timeFrame: one year
measure: Laboratory parameters
timeFrame: one year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Pediatric Research Centre, Tampere University Hospital and University of Tampere
state: Pirkanmaa
Study officials:
affiliation: University of Tampere, Tampere University hospital
name: Katri Kaukinen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurppa K, Paavola A, Collin P, Sievanen H, Laurila K, Huhtala H, Saavalainen P, Maki M, Kaukinen K. Benefits of a gluten-free diet for asymptomatic patients with serologic markers of celiac disease. Gastroenterology. 2014 Sep;147(3):610-617.e1. doi: 10.1053/j.gastro.2014.05.003. Epub 2014 May 13.
Clinical trial NCT02207205: Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture
Official title: A Study to Determine Variability in the Measurement of Whole Blood Clotting Time (WBCT) Between Blood Drawn From Indwelling Catheters and Direct Venipuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
First posted: 2014-08-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 1. Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture
2. Determine the intra-subject variability in both procedures

Detailed description: No investigational products were administered to any subjects.

Eligibility criteria: Inclusion Criteria:

1. Signed and dated, written informed consent (Institutional Review Board \[IRB\]-approved informed consent form \[ICF\]).
2. Healthy (as determined by medical history) male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture.

Exclusion Criteria:

1. Healthy subjects who do not conform to the above inclusion criteria.
2. Healthy subjects who cannot communicate reliably with the Investigator.
3. History of major bleeding or major trauma within the past 6 months
4. Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
5. Significant infection or known inflammatory process within 2 weeks of screening.
6. Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
7. Received non-steroidal anti-inflammatory drug (NSAID) or medications (including aspirin) with a direct effect on hemostasis within 7 days of testing
8. Unwillingness or inability to comply with procedures required in this protocol.
9. Subjects who are concurrently enrolled in any other clinical study.

Primary outcomes:
measure: Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture
timeFrame: single day sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Unit
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Unit
name: Robert Noveck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00766805: Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis
Official title: Endoscopic Variceal Ligation Plus Propranolol And Isosorbide Mononitrate Versus Endoscopic Variceal Ligation Alone For Secondary Prophylaxis Of Variceal Bleeding: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portal Hypertension
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2008-10-06
Enrollment: 177
Sex: ALL
Minimum age (years): 8
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background: Both endoscopic variceal ligation (EVL) and propranolol are valuable methods for secondary prophylaxis of variceal bleeding. Addition of ISMN to propranolol improves the efficacy of drug therapy. It is hypothesized that a combination of EVL and portal pressure reducing drugs should significantly be better than EVL alone.

Patients and Methods: Patients with history of variceal bleed were randomized to EVL plus drugs (propranolol and ISMN) or EVL alone. EVL was repeated every 3-4 weeks until variceal eradication. Propranolol dose was adjusted to reduce the resting heart rate to 55 bpm. Dose of ISMN was 40 mg/d. Primary end points were rebleed or death. Secondary end points included complications of portal hypertension and the development of serious adverse effects to therapy.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to G B Pant Hospital, New Delhi, with history of hematemesis and/or melena and proven to have esophageal varices as the bleeding source on upper GI endoscopy were included in the study.

Exclusion Criteria:

* A history of undergoing endoscopic sclerotherapy (EST), EVL, or cyanoacrylate injection;
* A history of surgery for portal hypertension;
* Coexisting malignancy;
* Severe cardiopulmonary or renal disease;
* A history of severe side-effects or contraindications to beta-blockers like bronchial asthma, uncontrolled diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, arterial hypotension (systolic blood pressure \< 100 mm Hg), bradycardia (basal heart rate \<55 beats per minute), or complete heart block; and
* Refusal to give consent to participate in the trial.

Primary outcomes:
measure: Primary end points of the study were bleeding and death.
timeFrame: During the study period
Secondary outcomes:
measure: Complications, UGI bleeding due to causes not related to PHT, and adverse effects that required the discontinuation of therapy.
timeFrame: During the study period
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Gastroenterology, G B Pant Hospital
state: Delhi
Study officials:
References:
Clinical trial NCT05033405: Neuro Linguistic Programming Pain Levels After Cesarean Delivery
Official title: The Effect of Neuro Linguistic Programming on Pain Levels After Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Pain, Postoperative
Keywords: NLP, cesarean section, postpartum, pain
Lead sponsor: Munzur University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 76
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study was conducted by using a prospective randomized single-blind clinical trial model.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to determine the effect of Neuro-Linguistic Programming (NLP) application on post-cesarean section pain levels.

Detailed description: The study was carried out between March 1 and June 1, 2021 with mothers who gave birth through cesarean section in the postpartum service of a maternity and children's hospital in the most populated city of Turkey, which is located in the west. The study data consists of a total of 76 individuals, including 38 in the experimental group and 38 in the control group. In the study, the effect size was calculated as 2.22. Accordingly, the power of the study, which was completed with 38 individuals in the control group and 38 in experimental group, had an effect size of 2.22, and used a significance level of 0.05, was calculated as 99.9%. The power analysis was conducted on the G\*Power software package.

Eligibility criteria: Inclusion Criteria:

* The study included individuals who

  * had a cesarean section,
  * were at the 6th to 24th hour postpartum,
  * agreed to participate in the study,
  * had a cesarean section for the first time,
  * did not use patient-controlled analgesia (PCA),
  * did not have an additional health problem that may cause pain in the postpartum period, other than cesarean incision pain, and
  * could speak and understand Turkish.

Exclusion Criteria:

* Mothers who wanted to quit on their own will at any stage after being included in the study, had verbal communication problems, had hearing or vision problems, or had previously been diagnosed with a psychiatric illness were excluded from the sample.

Primary outcomes:
measure: Examination of inter-and intra-group differences regarding VAS Scores
timeFrame: Immediately after the completion of the NLP application
Secondary outcomes:
measure: Distribution of participant characteristics by groups
timeFrame: 20 minutes after the first administration of the VAS
Other outcomes:
Locations:
city: Tunceli
country: Turkey
facility: Nursel Alp Dal
Study officials:
References:
Clinical trial NCT00291005: PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
Official title: A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: Prostate cancer
HRPC
AIPC
Hormone refractory
Androgen independent
Docetaxel
Taxotere
prednisolone
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 42
Sex: MALE
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
* To evaluate PSA (tumor marker) response rate
* To evaluate safety


Eligibility criteria: Inclusion Criteria:

* Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.

Exclusion Criteria:

* 1.Body temperature \> 38 degree centigrade.
* 2.Prior radiotherapy to \> 25% of bone marrow.
* 3.Prior isotope therapy and/or brachytherapy
* 4.Prior gene therapy.
* 5.Active double cancer.
* 6.Known brain or leptomeningeal involvement.
* 7.History of hypersensitivity reaction to drug
* 8.Other serious illness or medical condition
* 9.Subjects whom the investigators consider inappropriate from social or medical aspects.

Primary outcomes:
measure: Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
Secondary outcomes:
measure: Overall response rate by modified WHO criteria, PSA response rate, safety
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: CSD, PL / TA-Oncology
name: Atsushi NAKAMURA
role: STUDY_CHAIR
References:
Clinical trial NCT01381705: Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma
Official title: Validating the Predictive Value (of Response to Rituximab Induction and Maintenance) of the FCGR3A 158V/F Polymorphism Using Complimentary Genotyping Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-27
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled in E4402 from whom samples were submitted for research

Brief summary: RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in predicting response to rituximab treatment in samples from patients with indolent follicular lymphoma.

Detailed description: OBJECTIVES:

Primary

* Genotype the full cohort of samples available from the RESORT clinical trial (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results.
* Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to rituximab resistance.

Secondary

* Quantify copy number variation in FCGR3A in this cohort.

OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms using different complementary genotyping methods. Assay results are reviewed and compared with patients' outcome data.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosed with indolent follicular lymphoma
* Treated on RESORT trial (ECOG-E4402) comprising rituximab monotherapy and then randomized to rituximab maintenance therapy or retreatment with rituximab upon disease relapse

  * Blood and tissue samples from patients available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Correlation of FCGR3A 158V/F polymorphisms with response, duration of response, and time to rituximab resistance
timeFrame: 1 year
Secondary outcomes:
measure: Copy number variation in FCGR3A cohort
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Brad S. Kahl, MD
role: PRINCIPAL_INVESTIGATOR
References: