louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00093288: Major Depressive Disorder In The Elderly
Official title: A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible Dose Study to Evaluate the Efficacy, Safety and Tolerability of Extended-release Bupropion Hydrochloride (150mg-300mg Once Daily) in Elderly Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: MDD
bupropion
Depression
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-10-07
Enrollment: 364
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Major Depressive Disorder with DSM-IV criteria for their current episode for at least 8 weeks.

Exclusion Criteria:

* Patient has current or past history of seizure disorder or brain injury.
* Patient has a diagnosis of anorexia or bulimia within the past 12 months.
* Patient has a past or current DMS-IV diagnosis of schizophrenia or any other psychotic disorder(s).
* Patient has had a myocardial infarction within 1 year or a history of uncontrolled hypertension or unstable heart disease with 6 months.

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale
Other outcomes:
Locations:
city: Caboolture
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Everton Park
country: Australia
facility: GSK Investigational Site
state: Queensland
city: New Farm
country: Australia
facility: GSK Investigational Site
state: Queensland
city: St. Albans
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Mont-Godinne
country: Belgium
facility: GSK Investigational Site
city: Montignies-sur-Sambre
country: Belgium
facility: GSK Investigational Site
city: Mikkeli
country: Finland
facility: GSK Investigational Site
city: Amersfoort
country: Netherlands
facility: GSK Investigational Site
city: Grubbenvorst
country: Netherlands
facility: GSK Investigational Site
city: Hilversum
country: Netherlands
facility: GSK Investigational Site
city: Hoogvliet
country: Netherlands
facility: GSK Investigational Site
city: Wildervank
country: Netherlands
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00517088: Level of Physical Activities in Patients Before and After Breast Cancer Treatment
Official title: Level of Physical Activities in Patients Before and After Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Physical Activity
Breast Cancer
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2007-08-16
Enrollment: 2007
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Detailed description: Introduction: Breast cancer is the most common malignant neoplasy in women. The risk for breast cancer in a lifetime is high among north-american women, about one out of eight, with 66% of the cases occurring after menopause and 15% when women are under 40 years old. Published cohort studies show clear evidences that women who practice intense physical activities have the risk for breast cancer reduced. The risk reduction for these women is 70%, and 10% for those who practice physical activities at a low level. During adolescence and adult age, moderate to intense physical activities may protect against a future breast cancer development. But some questions still need to be answered: Were women with a breast carcinoma diagnosis already physically active during life? Were there changes in these physical activities after treatment? Why? Objectives: The aim of this study was to identify the level of physical activities in patients before and after breast carcinoma treatment, and to observe if there were changes in the level of these activities. Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Eligibility criteria: Inclusion Criteria:

* Patients whit diagnosis of breast cancer

Primary outcomes:
measure: breast cancer
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Flávio G Pinto
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06012188: Aged 3-6 on Children's Sleeping Habits
Official title: The Effect of Sleeping Companion Toy Given to Earthquake Victims Aged 3-6 on Children's Sleeping Habits
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Habits
Child
Lead sponsor: Kilis 7 Aralik University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: One of the most important points in sleep health is the sleep habits of children. Natural disasters cause sleep problems in children, increase or decrease in sleep duration, change in sleep habits and adversely affect sleep quality. According to Erikson's theory of psychosocial development, children aged 3-6 are entrepreneurs. It is the period when children begin to learn and apply the rules, and independence efforts are developed in the child. Negative sleep behaviors and sleep problems are common during this period, but children can develop positive sleep habits if properly and consistently guided by their parents. Rituals such as fairy tales, lullabies, night lamps, toys can help children relax and calm down and gain sleep habits.

Detailed description: The research design is a randomized controlled experimental type study designed to evaluate the effect of sleeping companion toys given to earthquake survivors aged 3-6 years on children's sleep habits.The Children's Sleep Habits Scale will be used to determine the sleep habits of children in the earthquake area by pre-interviewing the parents of children aged 3-6. Children aged 3-6 with sleep problems will be divided into control and experimental groups according to their scale scores. The part up to this section constitutes the preliminary test of our research.

Children aged 3-6 years in the control group and their parents will not receive any intervention.

Families of the children in the experimental group will be given a sleep companion gift to give to their children. Children's sleep habits scale will be applied as a post-test to determine children's sleep problems 15 days after they receive a gift from their sleep friend. Then, sleep habits scale mean scores will be calculated and a comparison will be made between pretest and posttest mean scores.

Eligibility criteria: Inclusion Criteria:

* Ages ranging from 3 to 6
* Earthquake living
* Parents being literate
* Parents and children who accepted the study and gave voluntary consent

Exclusion Criteria:

* Being a 3-6 year old child who has previously had a sleep disorder finding
* Being visually, hearing or speech impaired
* Children aged 3-6 with mental disorders

Primary outcomes:
measure: Children's Sleep Habits Scale
timeFrame: 15 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: fsaban@atauni.edu.tr
name: FATMA KURUDİREK
role: PRINCIPAL_INVESTIGATOR
affiliation: t.kadiroglu@atauni.edu.tr
name: Türkan KADİROĞLU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06595888: CT 5400 RT System Application Clinical Study
Official title: CT 5400 RT System Application Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Computed Tomography Workflow Assessment
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
Collaborators: name: Philips Healthcare (Suzhou) Co., Ltd.
First posted: 2024-09-19
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the satisfaction of the common functions, the operation convenience, and the whole system stability, and the safety of CT 5400 RT System.


Eligibility criteria: Inclusion Criteria:

* 18≤ Age ≤ 75 years old
* Subjects with Clear consciousness; Subjects can cooperate and act autonomously
* Subjects agree to participate in this clinical study and sign the subject's informed consent
* Women subjects of childbearing age should have a negative pregnancy test and should have no plans to become pregnant in the next 6 months

Exclusion Criteria:

* Subjects who do not have full capacity for civil conduct;
* Women subjects who are pregnant or in lactating phase;
* Subjects who have had a CT scan within one year;
* Subjects with a history of allergies or asthma, severe hepatic and renal insufficiency or hyperthyroidism in which are considered as contraindication for CT contrast-enhanced examination;
* According to the opinion of the investigator: any situation that may affect the evaluation of the results or expose subjects into health risk;
* Subjects with mental disorders who cannot cooperate with the examination

Primary outcomes:
measure: the satisfaction of the common functions
timeFrame: 30 days (anticipated)
measure: the operation convenience assessment
timeFrame: 30 days (anticipated)
measure: the system stability assessment
timeFrame: 30 days (anticipated)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02918188: Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD
Official title: Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host-disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Graft-versus-host Disease
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 21
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.

Detailed description: The investigators will evaluate clinical response rate, time to treatment Failure (TTF), overall survival (OS), and toxicity in cGVHD patients.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Male
* not pregnant female
* patients \<65 years old
* Diagnosis of cGVHD steroid refractory (no response after Prednisone ≥1mg/kg ) or steroid-dependent cGVHD (had an initial response followed by a cGVHD flare upon steroid taper)
* Patient intolerant to steroid therapy

Exclusion Criteria:

* Patients with stable disease, not well controlled by the current treatment
* Pregnancy
* HIV positive
* Severe liver or renal impairment: serum creatinine \>2.5 mg/dl; serum bilirubin\>2.5 mg/dl (without evidence of hepatic cGVHD)
* Uncontrolled malignancies including the persistence of the underlying malignancy before the Allogeneic Transplantation and the relapse of hematopoietic malignancy
* Any other investigational agents administered within last four weeks
* Cardiac insufficiency (\>grade II, New York Heart Association classification)
* Inability to comply with medical therapy or follow-up

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 12 months after date of start of Hydrogen
Secondary outcomes:
measure: Response Rate in each domain (RRD)
timeFrame: 12 months after date of start of Hydrogen
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, M.D.
role: STUDY_CHAIR
References:
citation: Qian L, Liu M, Shen J, Cen J, Zhao D. Hydrogen in Patients With Corticosteroid-Refractory/Dependent Chronic Graft-Versus-Host-Disease: A Single-Arm, Multicenter, Open-Label, Phase 2 Trial. Front Immunol. 2020 Nov 25;11:598359. doi: 10.3389/fimmu.2020.598359. eCollection 2020.
Clinical trial NCT01727388: Informativeness to Digital Rectal Examination
Official title: Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Cancer
Upper Rectum Cancer
Diverticulitis
Rectal Bleeding
Hernia
Keywords: rectal examination
colorectal cancer
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 320
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Digital rectal examination is an act clinically performed daily by physicians and surgeons. It remains the key diagnostic test and directs the therapeutic management of cancer of the lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.

However, no randomized study in colorectal surgery is not interested in evaluating the best position to perform a full rectal exam.


Eligibility criteria: Inclusion Criteria:

* colon or upper rectum cancer operated or not
* recurrent of colon or upper rectum cancer
* rectal bleeding
* hernia

Exclusion Criteria:

* woman
* paraplegic man
* bedridden patient
* current or previous pelvic radiotherapy
* History of prostatectomy
* emergency

Primary outcomes:
measure: realization of a full digital rectal examination
timeFrame: The consult could be done prior to the surgery or one month after the surgery
Secondary outcomes:
measure: assessment of sphincter according to the DRESS score
timeFrame: The consult can be performed prior to the surgery or one month after the surgery
measure: missing information during the rectal examination
timeFrame: The consult can be performed prior to the surgery or one month after the surgery
measure: Conversion rate decided by the examiner
timeFrame: The consult can be performed prior to the surgery or one month after the surgery
measure: Evaluation of the position by the patient
timeFrame: The consult can be performed prior to the surgery or one month after the surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens Universitary Hospital
city: Beauvais
country: France
facility: Beauvais General Hospital
Study officials:
References:
citation: Sabbagh C, Mauvais F, Vecten A, Ainseba N, Cosse C, Diouf M, Regimbeau JM. What is the best position for analyzing the lower and middle rectum and sphincter function in a digital rectal examination? a randomized, controlled study in men. Dig Liver Dis. 2014 Dec;46(12):1082-5. doi: 10.1016/j.dld.2014.08.045. Epub 2014 Sep 22.
Clinical trial NCT06155188: Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia
Official title: A Novel Post-transplant Regimen of PT/FLU+CY for Selectively Promoting Unrelated Cord Blood Engraftment in Haploidentical-cord Transplantation in Childhood Leukemia: a Single-arm, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia
Stem Cell Transplant
Cord Blood
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort

Detailed description: PTCy is a well-established haploidentical transplant regimen strategy. Moreover, unrelated cord blood (UCB) plays a critical role in the effects of GVL. However, the engraftment of grafts is unpredictable in the setting of a haplo-cord subsequent transplant. Therefore, applying a novel post-transplant regimen of PT/CY+FLU may selectively promote UCB engraftment in the setting of haplo-cord transplant.

Eligibility criteria: Inclusion Criteria:

* children acute leukemia

Exclusion Criteria:

* MODS

Primary outcomes:
measure: rate of UCB engraftment
timeFrame: initiate STR detection from day+15 thereafter weekly up to 1 year post-HSCT
measure: rate of leukemia free survival
timeFrame: 3 years post-HSCT
measure: rate of overall survival
timeFrame: 3 years post-HSCT
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Department of Pediatrics, Nanfang Hospital, Southern Medical University
name: Xiaoqin Feng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01345188: Ranolazine in Ischemic Cardiomyopathy
Official title: Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiomyopathy
Chest Pain
Dyspnea
Lead sponsor: Midwest Cardiovascular Research Foundation
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2011-04-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. The purpose of this study is to determine the efficacy of taking Ranexa versus placebo in patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.


Eligibility criteria: Inclusion Criteria:

1. Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an ACEI/ARB.
2. Anginal chest pain or dyspnea
3. Documentation of non treatable or optimally treated coronary artery disease
4. Ejection Fraction of less than or equal to 40%

Exclusion Criteria:

1. Less than 18 years of age
2. Pregnant or breast feeding
3. Patients with non ischemic cardiomyopathy

Primary outcomes:
measure: Anginal Frequency
timeFrame: 12 weeks
measure: Quality of Life Questionnaire
timeFrame: 12 weeks
measure: Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
Study officials:
affiliation: Midwest Cardiovascular Research Foundation
name: Nicolas W Shammas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00843388: A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria
Official title: A Randomized Doubleblind Placebo Controlled Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Nephropathy
Blood Pressure
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.


Eligibility criteria: Inclusion Criteria:

* type 1 diabetes
* age 18-80 years
* microalbuminuria

Exclusion Criteria:

* blood pressure\> 160/100 mmHg
* persistent macroalbuminuria
* pregnancy or in risc of this
* P-Potassium\>5.7 mmol/l
* Eplerone treatment

Primary outcomes:
measure: albuminuria, expected decrease
timeFrame: 60 days
Secondary outcomes:
measure: GFR
timeFrame: 60 days
measure: ambulatory blood pressure
timeFrame: 60 days
measure: plasma renin, angiotensin, aldosteron
timeFrame: 60 days
Other outcomes:
Locations:
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: stine e nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02846688: Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa
Official title: Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gene Expression Profiling
Gastric Intestinal Metaplasia
Duodenum
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University

Brief summary: To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal Mucosa.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for gastroendoscopy examination

Exclusion Criteria:

* Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium

Primary outcomes:
measure: Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: li yanqing, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: