louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02945735: Gaze Contingent Feedback in Major Depressive Disorder (MDD)
Official title: Gaze Contingent Feedback in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Unipolar
Depressive Disorder
Depressive Disorder, Major
Keywords: depression
cognitive bias modification
MDD
major depressive disorder
attention bias modification treatment
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of Major Depressive Disorder (MDD)

Detailed description: The study examines giving depressive participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.

Eligibility criteria: Inclusion Criteria:

* A signed consent form
* Men and women between the ages of 18 and 65.
* Meeting a current diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV
* MDD as the primary diagnosis: In cases of co-morbidity, MDD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
* Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.

Exclusion Criteria:

* Psychotic episode in the past or the present time.
* Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
* Another psychotherapeutic treatment during the study.
* Usage of neuroleptic medication.
* Change in medication status during the study.
* Substantial usage of drugs or alcohol in the present time.
* Poor judgment capacity (i.e., children under 18 and special populations).
* High Risk of Suicide.

Primary outcomes:
measure: Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA)
timeFrame: post treatment (1 week after treatment completion) and 3-month follow up
Secondary outcomes:
measure: Change from baseline - BDI-II - Beck Depression Inventory
timeFrame: post treatment (1 week after treatment completion) and 3-month follow up
Other outcomes:
measure: changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis
timeFrame: approximately 20 min
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01553435: Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients
Official title: Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Opioid Tolerance
Analgesia Tolerance
Keywords: Dextromethorphan
Morphine
Fentanyl
Opioid
analgesia
Efficacy
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients


Eligibility criteria: Inclusion:

* Patients above 2 years, admitted in PICU
* On Morphine or Fentanyl infusions for more than 48 hours

Exclusion Criteria:

* Patients under 2 years of age
* Patients with anticipated PICU length of stay less than 3 days.
* Patients shall be excluded if Morphine or Fentanyl infusions not continued for the minimum duration of 72 hours after enrollment
* Patients develops hemodynamic instability
* Patients with Hepatic failure
* Withdrawal request by parent(s)/guardian/family

Primary outcomes:
measure: Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
timeFrame: Two years
Secondary outcomes:
measure: Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
timeFrame: two years
measure: Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
timeFrame: Two years
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdul Aziz Medical City
state: Central
Study officials:
References:
citation: Naeem M, Al Alem H, Al Shehri A, Al-Jeraisy M. Effect of N-Methyl-D-Aspartate Receptor Antagonist Dextromethorphan on Opioid Analgesia in Pediatric Intensive Care Unit. Pain Res Manag. 2016;2016:1658172. doi: 10.1155/2016/1658172. Epub 2016 Oct 27.
Clinical trial NCT04822935: Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery
Official title: Evaluation of Surgical Methods in Terms of Postoperative Pain in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis; Adolescence
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 31
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Scoliosis is a 3-dimensional, structural deformity of the spine. Idiopathic scoliosis is the most common type and it constitutes 75-80% of all scoliosis. Surgical methods are the most effective way to correct the deformity in patients who cannot achieve adequate improvement with supportive therapy. Adolescent idiopathic scoliosis surgeries are among the most invasive surgeries performed on children and adolescents. Large surgical incision and massive tissue damage cause severe postoperative pain. In this study, we aim to compare posterior instrumentation (PE) and vertebral body tethering (VBT) surgeries performed in adolescent idiopathic scoliosis patients in terms of anesthetic management and postoperative pain.


Eligibility criteria: Inclusion Criteria:

* ASA score 1-3 patients
* Adolescent idiopathic scoliosis patients
* Patients who accepted to be included in the study and received written parental consent

Exclusion Criteria:

* Patients with vertebral anomaly due to a secondary reason
* Patients with a diagnosed syndrome
* Patients with a Cobb angle below 40.
* Patients who undergoing reoperation

Primary outcomes:
measure: Comparison in terms of postoperative pain
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
Study officials:
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Irem Basaran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canbolat N, Basaran I, Altun D, Akgul T, Buget MI. Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery: A Randomized Controlled Trial. Pain Physician. 2022 Jul;25(4):E589-E596.
Clinical trial NCT04551235: Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells
Official title: Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematologic Diseases
Artificial Intelligence
Acute Leukemia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Tai-Chen Cell Therapy Center, Biomdcare Corporation
First posted: 2020-09-16
Enrollment: 900
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have suspected or confirmed hematological diseases and receive bone marrow or peripheral blood cell morphological examination in National Taiwan University Cancer Center

Brief summary: Counting and classification of blood cells in a bone marrow smear and peripheral blood smear are essential to clinical hematology. To this date, this procedure has been carried out in a manual manner in the great majority of clinical settings. There is often inconsistency in the counting result between different operators largely due to its manual nature. There has not been an effective and standard method for blood smear preparation and automatic counting and classification. The recent advent of deep neural network for medical image processing introduced new opportunities for an effective solution of this long-standing problem. Numerous results have been published on the effectiveness of convolutional neural network in clinical image recognition task.


Eligibility criteria: Inclusion Criteria:

* Patients who have suspected or confirmed hematological diseases and receive bone
* marrow or peripheral blood cell morphological examination in National Taiwan University Cancer Center
* Patients who are aged more than 20 y/o

Exclusion Criteria:

•Patients who are not willing to sign informed consents

Primary outcomes:
measure: Evaluate the accuracy of cell counting and classifying between automatic method and manual method through digital microscopic photos of bone marrow smear and peripheral blood smear using deep convolutional neural networks
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Tai-Chen Cell Therapy Center
Study officials:
References:
Clinical trial NCT02677935: Impact of Peer Education Program on Headache Disorders
Official title: Impact of Peer Education Program on Headache Disorders in Rural Communities, India: a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache Disorder
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Kaithal Hospital
First posted: 2016-02-09
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Worldwide, headache disorders are among the most common medical conditions. Many people with headache need not experience further pain if the diagnosis and treatment are correct. Most patients do not have correct diagnosis and treatment. This study tested a model for treatment of people with headache disorders at primary health-care level in rural areas of Haryana, India.


Eligibility criteria: Inclusion Criteria:

* All residents of the Region Kaithal (haryana) may apply for recruitment
* Primary headache disorders including tension type headache, migraine

Exclusion Criteria:

* Planning to move the area
* Refused to consent

Primary outcomes:
measure: Reduction in number of days per month with headache after 12 months
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Reduction in number of days per month of over the counter drugs after 12 months
timeFrame: From Baseline to 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: NMP Medical Research Institute
name: Deepa Rani
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaithal Hospital
name: Neeraj Kumar
role: PRINCIPAL_INVESTIGATOR
affiliation: NMP Medical Research Institute
name: Ram Sharma
role: STUDY_DIRECTOR
References:
Clinical trial NCT00668135: Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia
Official title: Randomised, Double Blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Study to Evaluate the Efficacy and Tolerability of Vardenafil (BAY 38-9456) in Treatment of Male Erectile Dysfunction in Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 348
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)


Eligibility criteria: Inclusion Criteria:

* Age: 20 years and older- Males with erectile dysfunction
* Stable heterosexual relationship Exclusion Criteria:
* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use
* Other exclusion criteria apply according to the Summary of Product Characteristics

Primary outcomes:
measure: International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)
timeFrame: 12 weeks
Secondary outcomes:
measure: Global Assessment Question
timeFrame: 12 weeks
measure: Other diary responses
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
city: Jakarta
country: Indonesia
city: Petlaing Jaya
country: Malaysia
state: Salangor
city: Kuching
country: Malaysia
state: Sarawak
city: Kuala Lumpur
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Manila
country: Philippines
city: Manila
country: Philippines
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02490735: CIK in Treating Patients With Esophageal Cancer
Official title: A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy is the main treatment method for patients with Esophageal Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Esophageal Cancer.

Detailed description: About 2000 patients with staging I-III of Esophageal Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 weeks). Patients in group B will have no anti-tumor therapy.

Eligibility criteria: Inclusion Criteria:

* Patients histologically confirmed esophageal carcinoma;
* Patients with staging I-III of esophageal carcinoma;
* Patients who had completed chemotherapy;
* Patients who have a life expectancy of at least 12 weeks;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
* The bone marrow functioned normally (WBC\>4.0×10\^9/L, Hb\>120 g/L, Platelet(PLT)\>100×10\^9/L);
* The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

* Patients who had distant metastases by imaging studies;
* Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
* Patients who were lactating;
* ECOG perform status ≥ 2;
* Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
* Patients who are pregnant or nursing;
* Patients with active tuberculosis (highly positive skin tests allowed if no active disease);
* Patients with disease that would preclude general anesthesia;
* Patients with active intractable or uncontrollable infection.

Primary outcomes:
measure: progression-free survival(PFS)
timeFrame: 1 month
Secondary outcomes:
measure: overall survival(OS)
timeFrame: 1 month
Other outcomes:
measure: Stage at diagnosis
timeFrame: 1 month
Locations:
Study officials:
References:
Clinical trial NCT06818435: Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry
Official title: Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Valve Stenosis
TAVI(Transcatheter Aortic Valve Implantation)
Keywords: MyPORTuVal
TAVI
Portuguese TAVI Registry
Lead sponsor: Portuguese Association of Interventional Cardiology
Sponsor class: OTHER
Collaborators: name: Meril Life Sciences Pvt. Ltd.
First posted: 2025-02-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptomatic severe native aortic valve stenosis who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.

Brief summary: A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.


Eligibility criteria: Inclusion Criteria:

1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS) who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.
2. Patient has provided written informed consent as approved by the Ethics Committee (EC)
3. Patient is willing to undergo all registry procedures and follow-up requirements

Exclusion Criteria:

1. Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
2. Ongoing infective endocarditis or any similar infection.
3. Pregnant or lactating females.
4. Liver failure (Child-Pugh Class B or C)
5. Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.
6. Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.

Primary outcomes:
measure: Safety of Myval valve and TAVI procedure
timeFrame: 30 days
Secondary outcomes:
measure: Safety and Performance of Myval valve and TAVI procedure
timeFrame: 30 days and 12 Months
Other outcomes:
Locations:
city: Carnaxide
country: Portugal
facility: Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz
city: Coimbra
country: Portugal
facility: Unidade Local de Saúde de Coimbra
city: Lisbon
country: Portugal
facility: Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta
city: Lisbon
country: Portugal
facility: Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Unidade Local de São João E.P.E.
city: Évora
country: Portugal
facility: Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo
Study officials:
affiliation: Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz
name: Rui Campante Teles, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03704935: Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program
Official title: Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program in Patients With a Chronic Respiratory Disease: Time Course and Determinants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Respiratory Disease
Keywords: Pulmonary rehabilitation
Maintenance program
Cohort
Microenvironment
Long-term benefits
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 1000
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a chronic respiratory disease (COPD, Asthma, bronchiectasis , Fibrosis, Sleep Apnea, ...) undergoing pulmonary rehabilitation (maintenance or inpatient)

Brief summary: Chronic respiratory diseases are characterized by a progressive and long term deline. Pulmonary rehabilitation (exercise training and therapeutic education) can improve several disease outcomes like dyspnea, exercise tolerance and health-related quality of life. After an inpatient PR program, maintenance program can stabilize the disease outcomes. However, maintenance program are heterogeneous and long term benefits (\>36 month) have been observed in only one study, which is not feasible in France. A realistic maintenance program as proposed by the French Air+R network (http://airplusr.com/wordpress/) has only demonstrated benefits after 12 month. In addition, the time course of patients may be heterogeneous, with differens clusters that could be influenced by the clinical, functional and systemic determinants. In particular, the cellular muscle microenvironment could be deleterious for the muscle function in patients, caused by a "spill-over" of inflammatory pulmonary molecules in the systemic milieu.


Eligibility criteria: Inclusion criteria:

Patients with a chronic respiratory disease (COPD, Asthma, bronchiectasis , Fibrosis, Sleep Apnea, ...) undergoing pulmonary rehabilitation (maintenance or inpatient)

Exclusion criteria:

Contraindication to exercise training

Primary outcomes:
measure: 6 minutes walking distance
timeFrame: 10 years
Secondary outcomes:
measure: health-related quality of life
timeFrame: 10 years
measure: Forced expiratory volume in 1 seconde
timeFrame: 10 years
measure: BODE index
timeFrame: 10 years
measure: death
timeFrame: 10 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of clinical Physiology - University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Farés Gouzi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: