louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04781452: Evaluating the Treatment in the MZEB Aachen
Official title: Evaluating the Treatment in the the Center for Disabled People in Aachen (MZEB Aachen) - a Registry on Patients With Severe Disabilities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intellectual Disability
Disability Physical
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mixed Population of People with intellectual and severe multiple disability who need this care in this center

Brief summary: Evaluation of patient characteristics, involved physicians and therapists as well as therapies in a German University Center for the Treatment of patients with intellectual disabilities and severe multiple disability (MZEB Aachen)

Detailed description: In the MZEB Aachen, since 11/2018 patients with intellectual disabilities and/or severe multiple disabilities are diagnosed, treated and accompanied for many years in a multidisciplinary setting with physicians, nurses, physiotherapists, ergo therapists, speech therapists and Support by social workers. MZEBs are considered to have a pilot function in the health care system, cooperating with therapists and physicians in the surroundings. This concept is established as a new concept in Germany in order to optimise health care for patients with disabilities. Thus we want to investigate patient characteristics, diagnoses, involved physicians and therapists as well as proposed therapies and disease progress in this center.

Eligibility criteria: Inclusion Criteria:

* intellectual disability and/or severe multiple disability (disability degree GdB at least 70 and at least one noticeable sign
* willing to participate

Exclusion Criteria:

* housed in an Institution and/or prison

Primary outcomes:
measure: change in number of therapy sessions
timeFrame: baseline and after one year treatment
measure: Change in diagnoses
timeFrame: baseline and after one year treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University
state: Nordrhein Westfalen
Study officials:
affiliation: RWTH Aachen University
name: Jörg B Schulz, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00219752: Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
Official title: Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myeloid Leukemia
Keywords: CML - ederly patients - Imatinib mesylate
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.

Detailed description: Patients will received Imatinib at a dose of 400mg daily. Tolerability and quality of life will be assessed Secondary objectives are : to evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.

Duration of responses and failure to respond will be evaluated.

Eligibility criteria: Inclusion Criteria:

* CML Ph+ (assessed by cytogenetic or FISH)
* Chronic phase with less than 5% bone marrow blasts
* Diagnosis within 12 months
* Age ≥ 70 year at inclusion
* PS grade 0 to 2 (ECOG)
* Mini mental status more than 25
* Hydroxyurea optional before Imatinib
* Adequate end organ function, defined as the following: total bilirubin \<1.5x uln, sgpt \<3x uln, creatinine \<1.5x uln.

Exclusion Criteria:

* patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
* Mini mental status ≤ 25
* patients who are not able to adequately take the study drug
* Age less than 70 y
* accelerated or blastic phase
* previous therapy with imatinib or interferon
* HIV positivity

Primary outcomes:
measure: Tolerability
measure: Quality of life
Secondary outcomes:
measure: . the survival without progression
measure: . the survival without event
measure: . the overall survival
measure: . the hematologic cytogenetic and molecular responses at various check points.
measure: . duration of responses and failure to respond
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital
Study officials:
affiliation: Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
name: François GUILHOT, MD
role: STUDY_CHAIR
affiliation: Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)
name: Philippe ROUSSELOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02350452: Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Endometriomas
Official title: The Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Inner Lining of Ovarian Endometriomas After Laparoscopic Cystectomy: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Endometrioma
Keywords: laparoscopic surgery
diode laser
AMH
AFC
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: University of Foggia
First posted: 2015-01-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endometriosis is a benign chronic gynaecological disease that affects 10% of women of reproductive age and takes 40% of them to assisted reproduction techniques.

The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular count (AFC) , with the most common serological markers of ovarian reserve. The investigators intend to confirm their clinical utility in the assessment of ovarian function, and to promote their use in predicting decreased ovarian reserve.

The work therefore moreover arises the objective to validate the bibliographic data about using the laser for haemostasis after stripping endometriomas, to amplify knowledge available in the literature on the surgical treatment of ovarian endometriomas and on the diode laser application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the possible surgical implications on fertility .


Eligibility criteria: Inclusion Criteria:

* regular menstrual cycles
* unilateral endometrioma greater than 35 mm
* no gynecological surgery 3-6 months before surgery
* no hormonal therapy 1 month before surgery

Exclusion Criteria:

* previous surgery for endometriosis
* hormone therapy in the month before the current surgery
* coagulation disorders
* ongoing pregnancy
* pelvic inflammatory disease
* malignant disorders
* cysts otherwise
* Gonadotropin-releasing hormone analogues or contraceptive therapy during the follow-up
* BMI≥ 30 kg/m2
* endocrinological disorders
* unable or unwilling to give written consent

Primary outcomes:
measure: Anti-Müllerian hormone (AMH) serum levels
timeFrame: Change from AMH serum levels at 3 months after surgery
Secondary outcomes:
measure: Antral follicular count (AFC)
timeFrame: Change from AFC at 3 months after surgery, during early follicular phase
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: University of Cagliari,Obstetrics and Gynecological Department,
state: Cagliari
Study officials:
References:
Clinical trial NCT03237052: Validating and Optimizing Model of Antipsychotics Selection
Official title: A Randomized Controlled Multi-center Clinical Study Focusing on Validating and Optimizing Model of Antipsychotics Selection in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics treatment in Chinese Patients with Schizophrenia by comparing model-decision with real-world psychiatrist-decision. The three atypical antipsychotics are olanzapine (5-20 milligram per day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). The main purpose of this study is to explore the potential difference between modal-aided-decision with clinician-decision in order to validate and optimize the selection model that has been established in advance.

The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. Visits occurs at 0, 4, 8, 13, 26, 52 weeks.


Eligibility criteria: Inclusion Criteria:

* An in-patient or out-patient (male or female) and aged ≥18 years
* A diagnosis of schizophrenia, DSM-5 (Diagnostic and Statistical Manual Diploma in Social Medicine-5)
* Subjects must have the ability to effectively communicate with investigator, complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures.
* Patients are taking or will take atypical antipsychotics which include olanzapine, risperidone, aripiprazole.
* Baseline PANSS Total Score ≥70

Exclusion Criteria:

* Participation in other clinical studies.
* Known intolerance or lack of efficacy to olanzapine, risperidone or aripiprazole.
* Use of clozapine within 28 days prior to randomization.
* Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.

Primary outcomes:
measure: Change of PSP from Baseline
timeFrame: 52 weeks
Secondary outcomes:
measure: Change of PANSS from Baseline
timeFrame: 52 weeks
measure: Change of CDSS from Baseline
timeFrame: 52 weeks
measure: Change of CGI from Baseline
timeFrame: 52 weeks
measure: Change of liver function from Baseline
timeFrame: 52 weeks
measure: Change of PRL from Baseline
timeFrame: 52 weeks
measure: Number of Participants with EPS
timeFrame: 52 weeks
measure: Number of Participants with abnormal ECG
timeFrame: 52 weeks
measure: Number of Participants with abnormal sexual function
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: GCP Office
name: Yifeng SHEN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960152: Periodontal Impact of Eating Disorders (the PERIOED Study)
Official title: Periodontal Impact of Eating Disorders (the PERIOED Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Diseases
Eating Disorder
Anorexia Nervosa
Bulimia Nervosa
Keywords: periodontitis
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2016-11-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients suffering from eating disorders referred to the Psychiatric and Addiction department at the Paul Brousse Hospital (Villejuif, France)

Brief summary: This study evaluated the periodontal status of patients suffering from eating disorders (anorexia nervosa and bulimia nervosa). The work hypothesis is that eating disorder patients have a higher risk for periodontal diseases than non-eating disorder subjects.

Detailed description: Eating disorders have been associated with poor oral health. However, the relationship between eating disorders and periodontal diseases is less-established. Participants will be periodontally assessed using a full-mouth clinical evaluation.

Eligibility criteria: Inclusion Criteria:

* In and out eating disorder patients
* Subject with a diagnosis of anorexia nervosa or bulimia nervosa for at least 5 years
* Subject affiliated to the French social insurance

Exclusion Criteria:

* Subject who do not speak French
* Subject who is not able to read and/or understand the information form
* Subject who take anti-inflammatory medications or antibiotics at dental examination
* Subject who has received any dental treatment that could interfere with the periodontal status 3 month before the clinical examination (scaling and root planning, orthodontic treatment ongoing)
* Subject who has less than 10 teeth

Primary outcomes:
measure: Clinical Attachment Loss (CAL)
timeFrame: at examination day
Secondary outcomes:
measure: gingival inflammation
timeFrame: at examination day
Other outcomes:
Locations:
city: Paris
country: France
facility: Rothschild Hospital
city: Villejuif
country: France
facility: Paul Brousse Hospital
Study officials:
affiliation: Paris Diderot University
name: Philippe Bouchard, DDS, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05122832: Prevalence of NCD Risk Factors in Kazakhstan
Official title: Preventive and Personalized Medicine (2021-2023)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Communicable Chronic Diseases
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 20400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All ethnic groups in Kazakhstan

Brief summary: This is a cross-sectional study that aims to study the prevalence of risk factors of noncommunicable diseases in people aged 18 to 69 years using the standardized and adopted STEPS questionnaire in the Republic of Kazakhstan.

Detailed description: The WHO STEPwise Approach to NCD Risk Factor Surveillance (STEPS) is a simple, standardized method for collecting, analysing and disseminating data on key NCD risk factors in countries. The survey instrument covers key behavioral risk factors: tobacco use, alcohol consumption, physical activity, unhealthy diet, as well as key biological risk factors: overweight and obesity, raised blood pressure, raised blood glucose, and abnormal blood lipids.

Eligibility criteria: Inclusion Criteria:

* Age Limits 18-69 years

Primary outcomes:
measure: tobacco use
timeFrame: 1 year
measure: alcohol consumption
timeFrame: 1 year
measure: physical activity
timeFrame: 1 year
measure: unhealthy diet
timeFrame: 1 year
measure: BMI
timeFrame: 1 year
measure: raised blood pressure
timeFrame: 1 year
measure: raised blood glucose
timeFrame: 1 year
measure: abnormal blood lipids
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakhstan
Study officials:
affiliation: S.D. Asfendiyarov Kazakh National Medical University
name: Timur M Saliev
role: PRINCIPAL_INVESTIGATOR
affiliation: S.D. Asfendiyarov Kazakh National Medical University
name: Ildar Fakhradiyev, PhD
role: STUDY_CHAIR
affiliation: S.D. Asfendiyarov Kazakh National Medical University
name: Mukhtar B Kulimbet, MD/MSc
role: STUDY_DIRECTOR
affiliation: Joint Stock Company - South Kazakhstan Medical Academy
name: Zhumaly A Kauyzbay, PhD, AP
role: PRINCIPAL_INVESTIGATOR
affiliation: West Kazakhstan Marat Ospanov Medical University
name: Samat S Saparbayev, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NCJSC Semey Medical University
name: Alma U Nurtazina, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NCJSC Astana Medical University
name: Bayan A Ainabekova, MD/DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: NCJSC Karaganda Medical University
name: Anar A Turmukhambetova, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Kazakhstan's Medical University "KSPH"
name: Maksut K Kulzhanov, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00686452: Airway Dysfunction and Remodelling in Athletes Following Swimming Training in Chlorinated Pools
Official title: Airway Dysfunction and Remodelling in Athletes Following Swimming Training in Chlorinated Pools
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Airway Hyperresponsiveness
Keywords: Asthma
Airway hyperresponsiveness
Swimmers
Airway inflammation
Airway remodelling
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2008-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Swimmers from Quebec swimming school and universities Control from université Laval or secondary School

Brief summary: Swimmers show the highest prevalence of asthma among elite athletes, certainly due to chlorine exposure. The consequences of a chronic exposure to chlorine compounds by swimmers and the mechanisms of asthme in this population are still poorly documented. Specific diagnostic criteria have been proposed by the International Olympic Committee - Medical Council (IOC-MC) and World anti-doping agency (WADA) to determine the presence of asthma in athletes. Using the more specific bronchial provocation tests, our aims are

1. to compare the prevalence of asthma in swimmers and control subjects
2. to analyze the Influence of chlorine exposure on bronchial inflammatory processes in swimmers versus control subjects
3. to study the time-course of changes in airway symptoms, responsiveness, inflammation and remodeling after cessation of training


Eligibility criteria: Inclusion Criteria:

* 14 to 35 years old
* To swim at least 10h per week
* For control subjects, non-competitive healthy subjects

Exclusion Criteria:

* any disease that may interfere with the tests for the controls
* Triathletes are excluded
* Smokers
* Obese or with a BMI more than 29
* Former athletes (control group)

Primary outcomes:
measure: Asthma and airway hyperreactivity prevalence in swimmers
timeFrame: 3 measurements in the year
Secondary outcomes:
measure: Airway inflammation and remodeling in swimmers
timeFrame: 3 measurements in the year and a bronchial biopsy
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de recherche en pneumologie et en cardiologie de l'hôpital Laval
state: Quebec
Study officials:
References:
citation: Bougault V, Odashiro P, Turmel J, Orain M, Laviolette M, Joubert P, Boulet LP. Changes in airway inflammation and remodelling in swimmers after quitting sport competition. Clin Exp Allergy. 2018 Dec;48(12):1748-1751. doi: 10.1111/cea.13257. Epub 2018 Sep 14. No abstract available.
citation: Bougault V, Turmel J, Boulet LP. Bronchial challenges and respiratory symptoms in elite swimmers and winter sport athletes: Airway hyperresponsiveness in asthma: its measurement and clinical significance. Chest. 2010 Aug;138(2 Suppl):31S-37S. doi: 10.1378/chest.09-1689. Epub 2010 Apr 2.
Clinical trial NCT01486732: FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy
Official title: FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Umbilical Cord Blood
FLT-PET
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.

Detailed description: FLT(3'-Deoxy-3'-\[F-18\]Fluorothymidine) has been developed as a cell-proliferation tracer. In animal study, FLT-PET was used as a tool that enables imaging and measuring of proliferation in the brain, thus it detects activity of endogenous neural stem cells noninvasively. This study aims to assess cell proliferation activity changes in the brain after Umbilical Cord Blood (UCB)Therapy for Cerebral Palsy patients using FLT-PET.

Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy
* Abnormal muscle tone
* Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
* Willing to comply with all study procedure

Exclusion Criteria:

* Medical instability including pneumonia or renal function at enrollment
* Presence of known genetic disease
* Presence of drug hypersensitivity which is related to this study remedy
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome

Primary outcomes:
measure: Comparison of FLT-PET Activity Change
timeFrame: Baseline - 2 weeks
Secondary outcomes:
measure: Changes in Neurodevelopmental Outcome
timeFrame: Baseline - 2 weeks - 3 months
measure: Changes in Standardized Gross Motor Function
timeFrame: Baseline - 2 weeks - 3 months
measure: Changes in Quality of Movement
timeFrame: Baseline - 2 weeks - 3 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: Minyoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: