louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03413670: Neural Mechanism Underlying Social Cognition in Depressive Patients
Official title: Neural Mechanism Underlying Social Cognition in Depressive Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
Collaborators: name: Huilongguan Hospital
First posted: 2018-01-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals diagnosed with depression and healthy control

Brief summary: In the project, investigators plan to test difference of social cognition between depressive patients and healthy individuals and the brain activation underlying the difference to further understand the neural mechanism of depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Age range between 18 and 60
* Education experience above high school
* Score for Hamilton's Depression Scale \>=17
* Diagnosis of depression through Scid

Exclusion Criteria:

* Undergoing electric shock treatment in 3 months
* Excluding those who with bipolar disorder
* Excluding those who with postpartum depression
* Excluding those who with hysteria

Primary outcomes:
measure: emotion recognition
timeFrame: Baseline
measure: resting state
timeFrame: Baseline
measure: self-reflection
timeFrame: Baseline
measure: response to negative stimuli
timeFrame: Baseline
measure: structure
timeFrame: Baseline
measure: white matter
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Huilongguan Hospital
Study officials:
References:
Clinical trial NCT02658370: An Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis
Official title: A Prospective Pilot Study to Evaluate an Animated Home-based Physical Exercise Program as a Treatment Option for Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: physical exercises
physical therapy
Wii game console
patients perspective
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to investigate feasibility and patients´ assessment using an animated home-based exercise program (Software Wii-fit of the Nintendo Wii game console) for patients with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Patients fulfilling the 1987 and 2010 American College of Rheumatology (ACR) criteria for rheumatoid Arthritis
* Disease activity (patients' global assessment, PtGA) \< 30 mm under therapy with a biological DMARD according to label

Exclusion Criteria:

* Epilepsy
* Flare of RA
* A previous use of a Wii console for more than 5 hours

Primary outcomes:
measure: feasibility of the animated home-based physical exercise program
timeFrame: 12 weeks
Secondary outcomes:
measure: muscle strenght measurement
timeFrame: 12 weeks
measure: 6-minute walk test
timeFrame: 12 weeks
measure: respiratory function test
timeFrame: 12 weeks
measure: Health Assessment Questionnaire Disability Indes (HAQ-DI)
timeFrame: 12 weeks
measure: patient's visual analogue scale for pain
timeFrame: 12 weeks
measure: patient's visual analogue scale for disease activity
timeFrame: 12 weeks
measure: short form 36 questionnaire (SF36)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Charité Berlin, Department of rheumatology and clinical immunology
name: Eugen Feist, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zernicke J, Kedor C, Muller A, Burmester GR, Reisshauer A, Feist E. A prospective pilot study to evaluate an animated home-based physical exercise program as a treatment option for patients with rheumatoid arthritis. BMC Musculoskelet Disord. 2016 Aug 18;17(1):351. doi: 10.1186/s12891-016-1208-3.
Clinical trial NCT05333770: Repetitive Transcranial Magnetic Stimulation to Promote Regeneration in Persons With SCI
Official title: Repetitive Transcranial Magnetic Stimulation as a Means to Promote CST Axon Regeneration in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a research study to evaluate the safety, efficacy and feasibility of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) in patients with subacute spinal cord injury.

Detailed description: This research study is investigating whether repetitive high-frequency transcranial magnetic stimulation (HF-rTMS) in patients with subacute spinal cord injury is safe, efficacious, and feasible. The study will take approximately 7-8 months to complete, during which 15 training sessions with HF-rTMS will be completed. Followed by 30 minutes each session of arm and hand training without HF-rTMS. The participants will complete testing after the 15 training sessions as well as 6 months following completion.

Eligibility criteria: Inclusion Criteria:

* Be less than 8 weeks post injury
* Must have an incomplete spinal cord injury at a neurological level of injury between the C2-C6 level and an impairment grade A, B, C, or D, according to the American Spinal Injury association (ASIA) Impairment Scale
* If an outpatient, will be at least 6 months post injury

Exclusion Criteria:

* Have a pacemaker
* Have metal in the skull
* Have a history of seizures, or a brain injury
* Being pregnant
* Have skin issues or open wounds
* Have severe contractures and/or spasms in my elbow/wrists as determined by study staff examination at screening
* Study staff will review medications to determine if taking any drugs that would increase risk of having a seizure while undergoing TMS. If taking such medications, will not be enrolled

Primary outcomes:
measure: Neuro Recovery Scale (NRS).
timeFrame: 6 months
measure: GRASSP
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT01375270: Glucolipotoxicity and Type 2 Diabetes
Official title: The Effects of Experimental Elevation of Plasma Glucose and Lipid on Pancreatic Beta-cell Function in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
incretin
beta-cell function
glucolipotoxicity
glucagon-like peptide 1
glucose-dependent insulinotropic polypeptide
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Elevations of blood glucose and lipid are thought to be deleterious to the insulin secretory function of the pancreas. This is known as glucolipotoxicity. However, few studies have examined this in detail. This investigation will examine pancreatic insulin secretory function in physiological models of glucolipotoxicity such as obese and type 2 diabetic individuals. Furthermore, healthy subjects will undergo 24 hour infusion of glucose or Intralipid to induce experimental models of glucolipotoxicity. Insulin secretion in response to intravenous infusions of glucose, GLP-1, GIP, and arginine and in response to meal ingestion, will be examined. the investigators hypothesize that experimental glucolipotoxicity will impairs pancreatic insulin secretory function to levels akin to that seen in type 2 diabetics.


Eligibility criteria: Inclusion Criteria:

* normal glucose tolerance based on screening OGTT or
* diagnosed type 2 diabetic (confirmed with OGTT)

Exclusion Criteria:

* insulin dependent diabetes
* age \<18 or \>65 years
* BMI \<20 or \> 35 kg/m2
* evidence of hematological, pulmonary, hepatic, renal, or cardiovascular disease
* actively undergoing weight-loss (\>2kg change in last 6 months)
* bariatric surgery (gastric by-pass or banding)
* pregnancy
* smoking

Primary outcomes:
measure: Insulin Secretion
timeFrame: 24 hours
Secondary outcomes:
measure: Insulin Sensitivity
timeFrame: 24 hours
measure: Plasma Cytokines (IL-6, TNF, IL-1beta, IL-1ra)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Centre of Inflammation and Metabolism, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Thomas P Solomon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02512770: Hemodynamic and Respiratory Effects of Esophageal Dilation in Children
Official title: Esaphageal Balloon Dilatation in Children: Hemodynamic , Ventilatory Changes and Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstruction of Esophagus
Respiratory Complication
Hemodynamic Instability
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Ayse Cigdem Tutuncu
name: Senol Emre
name: Fatis Altindas
name: Kaya, Guner, M.D.
First posted: 2015-07-31
Enrollment: 60
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control.

Detailed description: Esophageal strictures in children may develop as a secondary to a surgically repaired esophageal atresia (anastomatic strictures) or as a result of chemical injury after caustic ingestion. Emerging strictures are dilated with balloon catheter at regular intervals.

The possibility of various complications depending on the level of the stenosis during the dilation of esophagus. During Esophageal dilation may be pressed into airways and/or vascular structure.

Eligibility criteria: Inclusion Criteria:

* endoscopy for esaphageal dilatation and control
* ASA I-III
* 0-16 year old

Exclusion Criteria:

* ASA IV
* endoscopy for removing foreing body

Primary outcomes:
measure: peak inspiratory pressure
timeFrame: at time of endoscopy(0-40minute)
Secondary outcomes:
measure: complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)
timeFrame: at time of endoscopy and after the endoscopy within 2 hours
measure: Sp02
timeFrame: at time of endoscopy and after the endoscopy within 2 hours
measure: pressure levels for target tidal volume
timeFrame: at time of endoscopy(0-40minute)
measure: mean arterial pressure-mmHg
timeFrame: at time of endoscopy(0-40minute)
measure: heart rate-per/min
timeFrame: at time of endoscopy(0-40minute)
Other outcomes:
Locations:
Study officials:
affiliation: Deapartment of Anesthesiology and Intensive Care, Cerrahpasa Medical Faculty,Istanbul University
name: Guner Kaya, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03979170: Patient-derived Organoids of Lung Cancer to Test Drug Response
Official title: Patient-derived Organoids of Lung Cancer to Test Drug Response
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Organoid
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 50
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: All patients (estimated 50 patients) with histologically proven lung cancer undergoing surgery related to this cancer at the University Hospitals of Geneva.

Brief summary: This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 3 years. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) Model of lung cancer to predict the clinical efficacy of anti-cancer drugs, in order to predict the best chemotherapy regimen for each given patient.

Detailed description: The aim of the project is to use a combination of patient-derived organoid models:

* To amplify tumour tissue to obtain enough material for genomic and histological analysis
* to characterize the lung cancer sub-type
* To predict treatment (non)response.

The following points will be addressed:

1. First, the investigators plan to establish and characterize formation of organoids from biopsies of patients with lung cancer: in spheroids, in the 3D cellular model OncoCilAirTM (OncoTheis), and on the chick chorioallantoic membrane (CAM). Patient-derived organoids from tumoural tissue (PDO) will be characterized and compared to the original tumour.
2. Second, the investigators will test the chemoresponse (chemosensitivity and chemoresistance) of organoids to anti-cancer treatment.

Eligibility criteria: Inclusion Criteria:

* Histologically proven lung cancer
* Age ≥ 18
* Written informed and signed consent
* Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour

Exclusion Criteria:

* Less than 18 years of age
* Not able to give informed consent (language, intellectual capacities, etc.)
* Not accessible to biopsy and/or surgery sample
* Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.

Primary outcomes:
measure: Patient-derived organoid establishment
timeFrame: 3 years
measure: Patient-derived organoid validation
timeFrame: 5 years
Secondary outcomes:
measure: Drug sensitivity
timeFrame: 2019 - 2023
measure: Prediction of the response to treatment by the patient-derived organoids
timeFrame: 2020 - 2025
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References:
citation: Mueggler A, Pilotto E, Perriraz-Mayer N, Jiang S, Addeo A, Bedat B, Karenovics W, Triponez F, Serre-Beinier V. An Optimized Method to Culture Human Primary Lung Tumor Cell Spheroids. Cancers (Basel). 2023 Nov 25;15(23):5576. doi: 10.3390/cancers15235576.
Clinical trial NCT02892370: Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects
Official title: An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male
* BMI:19-24 kg/m2, weight \> 50 kg.
* Age:18-45

Exclusion Criteria:

* History of clinically significant laboratory results or disease.
* History of alcohol or drug abuse.

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SHR0302
timeFrame: up to 72 hrs postdose
measure: The area under the plasma concentration-time curve (AUC) of SHR0302
timeFrame: up to 72 hrs postdose
measure: The accumulative excretion rate of SHR0302 and its metabolites in urine and feces
timeFrame: up to 96 hrs postdose
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety
timeFrame: up to Day 21
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Xuhui Central Hospital
name: Chen Yu, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01761370: Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
Official title: Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Alcoholic Steatohepatitis
Keywords: Non alcoholic Steatohepatitis
Intra-gastric balloon
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).

Detailed description: The Bio-enteric Intra-gastric balloon (BIB) has been shown to be an effective treatment for weight reduction in obese patients. This study will determine the feasibility of using BIB in the treatment of patients with Non alcoholic Steatohepatitis (NASH). It will evaluate the efficacy of the BIB in improving histology of NASH in obese patients.

Eligibility criteria: Inclusion Criteria:

* Patients between 21-65 years of age,
* Had histological evidence of NASH,
* Had a BMI of greater than 27kg/m2, and
* Had failed at least 6 month trial of medical therapy for weight reduction.

Exclusion Criteria:

* Patients with any organic disease of the upper GI tract,
* Were receiving anti-inflammatory drugs,
* Anticoagulants or steroids, or
* Had a history of alcoholism or drug addiction. A hiatus hernia of \> 5 cm, an active gastric or duodenal ulcer, and prior or intestinal surgery were considered contraindications to the placement of BIB.

Primary outcomes:
measure: Change in liver histology
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Yin Mei Lee, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511770: Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions
Official title: Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Fluconazole Tablets 200 mg and PFIZER (DIFLUCAN) 200 MG in Healthy Males Under Fasting Condition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Fluconazole
Crossover
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fasting conditions.

Detailed description: Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 18 healthy adult male volunteers. A total of 17 subjects completed the clinical phase of the study. In each period, subjects were housed from the morning dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 days.

Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

History or presence of significant:

• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.

Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.

Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.

Subjects who, through completion of the study, would have donated in excess of:

* 500 mL of blood in 14 days, or
* 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
* 1000 mL of blood in 90 days,
* 1250 mL of blood in 120 days,
* 1500 mL of blood in 180 days,
* 2000 mL of blood in 270 days,
* 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: pre dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,4, 6, 9, 12, 24, 48 and 72 hours post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Cohen street, saint-laurent, montreal (quebec)
country: Canada
facility: MDS Pharma Services
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00220870: Shared Decision Making for Schizophrenia
Official title: Shared Decision Making in the Therapy of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
shared decision making
compliance
maintenance therapy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2005-09-22
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: PREVENTION

Brief summary: The impact of a decision aid for inpatients with schizophrenia on perceived involvement and compliance is studied in comparison with routine care.

Detailed description: to follow

Eligibility criteria: Inclusion Criteria:

* schizophrenia (ICD10)
* age 18 - 65 years
* inpatients

Exclusion Criteria:

* mental retardation
* no informed consent

Primary outcomes:
measure: Patients' compliance
Secondary outcomes:
measure: perceived involvement in medical decisions
measure: rehospitalizations
measure: QoL
Other outcomes:
Locations:
city: München
country: Germany
facility: Psychiatric Department, TU München
Study officials:
affiliation: TU München, Psychiatric Department
name: Werner Kissling, MD
role: STUDY_CHAIR
References: