louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03122171: Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
Official title: Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Prosthesis User
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 6
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in improving the upper extremity function of children with cerebral palsy who have limited use of their hands. Twelve children, aged 4-17 years, who have cerebral palsy and limitations in their ability to use their hands, will be enrolled. All participants will be fitted with a 3D printed arm/hand prosthesis and receive 8 occupational therapy sessions. Each subject will be evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up. The evaluation will include assessment of (1)passive and active arm/hand movement and (2)functional hand skills using several standardized tests. The results from the pre-treatment and the two post-treatment evaluations will be compared.


Eligibility criteria: Inclusion Criteria:

* Diagnosis: cerebral palsy
* 4-17 years old
* MACS levels III - V
* Active movement of wrist or elbow

Exclusion Criteria:

* MACS levels I, II
* Botox or orthopedic surgery in past 6 months
* Severe contractures
* Lack of voluntary arm motion

Primary outcomes:
measure: Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score
timeFrame: Week 8
measure: Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment
timeFrame: 8 weeks
measure: Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores
timeFrame: Week 8
Secondary outcomes:
measure: Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Alice Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605471: A Study to Learn More About the Safety of Ultravist in Children and in the Elderly
Official title: Safety Profile of Ultravist in Children and Elderly (UV Age)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersensitivity
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-10-28
Enrollment: 132850
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients who received a contrast enhanced X-ray based examination with Ultravist for various clinical reasons

Brief summary: Ultravist is an iodine-based contrast agent that helps to make medical imaging scans clearer. It is also called iopromide, and it is available for doctors to give patients before they have scans. Even after a treatment or substance has been approved for use, researchers continue to study it to learn more about its safety.

Researchers have done studies on the safety of Ultravist, but they want to learn more about specific medical problems called hypersensitivity reactions (HSRs). These are undesirable immune system reactions to the study drug. In this study, the researchers will compare the risk of HSRs in children and in the elderly to the risk of HSRs in middle aged adults.

The researchers will look at information about medical problems that happened in people in 4 other studies. These studies are called PMS I, IMAGE, TRUST, and Ultravist in CT. A total of about 139,000 people will be included in this study.

All of the people in the earlier 4 studies received Ultravist as an injection into the vein or artery before having a scan. In this study, the researchers will compare the number of children, middle aged adults, and elderly patients who had HSRs after receiving Ultravist.


Eligibility criteria: Inclusion Criteria:

* We included patients of all age groups which were referred to a iodine-based contrast-enhanced procedure of any body part.

Exclusion Criteria:

* Patients with missing age, sex or who did not receive Ultravist 300 or 370 were excluded.

Primary outcomes:
measure: Number of participants with hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adults
timeFrame: Analysis will be done in 2 months
Secondary outcomes:
measure: Profile of HSRs (hypersensitivity reactions) in the three age groups
timeFrame: Analysis will be done in 2 months
measure: General reported ADR (adverse drug reactions) profile in the three age groups
timeFrame: Analysis will be done in 2 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Four company sponsored non-interventional studies with iopromide
Study officials:
References:
citation: Endrikat J, Chernova J, Gerlinger C, Pracz M, Lengsfeld P, Bhatti A, Michel A. Risk of Hypersensitivity Reactions to Iopromide in Children and Elderly: An Analysis of 132,850 Patients From 4 Observational Studies and Pharmacovigilance Covering >288 Million Administrations. Invest Radiol. 2022 May 1;57(5):318-326. doi: 10.1097/RLI.0000000000000840.
Clinical trial NCT03463278: The Number of Blastocysts Formed in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate
Official title: The Impact of Blastulation Rate in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy, Ovarian
Keywords: blastocyst
Freeze-all
IVF
Cumulative results
cumulative delivery rate
Lead sponsor: Assisting Nature
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 20-39 years old following blastocyst culture after ICSI cycle in Freeze all Strategy

Brief summary: A prospective study of the blastulation rate in the outcome of the Freeze all strategy

Detailed description: A prospective study of the blastulation rate in women under the age of 40 years following Freeze all strategy, according to AMH levels and sperm parameters.

Study group 1: number of vitrified blastocysts 0-4 Study group 2: number of vitrified blastocysts 5-7 Study group 3: number of vitrified blastocysts \>7

Eligibility criteria: Inclusion Criteria:

* primary infertility
* age 20-39 years;
* body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35days,
* presumed to be ovulatory;
* \>1mil/ml spermatozoa;
* short antagonist protocol

Exclusion Criteria:

* poor responders;
* age ≥40;
* TESE sperm;
* PGS cycles;
* donor oocytes;
* donor sperm

Primary outcomes:
measure: Cumulative Live Birth rate according to blastulation rate
timeFrame: 5 days of embryo culture
Secondary outcomes:
measure: Cumulative Pregnancy rate according to blastulation rate
timeFrame: 5 days of embryo culture
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Assisting Nature
Study officials:
affiliation: Assisting Nature
name: Evangelos Papanikolaou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02065778: Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke
Official title: A Clinical Study of Autologous Bone Marrow Mononuclear Cells Intrathecal Transplantation in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cerebrovascular Accident
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to study the safety and effect of stem cell therapy on the functional recovery in patients with chronic stroke.


Eligibility criteria: Inclusion Criteria:

* males and females
* above 18 years of age
* diagnosed as stroke by clinical and MRI findings

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever
* hemoglobin less than 8
* bleeding tendency
* bone marrow disorder
* left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding

Primary outcomes:
measure: Functional Independence Measure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
affiliation: Neurogen Brain and Spine Institute
name: Alok K Sharma, M.S., M.Ch
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borlongan CV. Bone marrow stem cell mobilization in stroke: a 'bonehead' may be good after all! Leukemia. 2011 Nov;25(11):1674-86. doi: 10.1038/leu.2011.167. Epub 2011 Jul 5.
citation: Sharma A, Sane H, Gokulchandran N, Khopkar D, Paranjape A, Sundaram J, Gandhi S, Badhe P. Autologous bone marrow mononuclear cells intrathecal transplantation in chronic stroke. Stroke Res Treat. 2014;2014:234095. doi: 10.1155/2014/234095. Epub 2014 Jul 8.
Clinical trial NCT04162678: Fluid Biopsy for the Diagnosis of Lung Cancer
Official title: Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a biopsy or CT screening for lung cancer

Brief summary: This trial collects and studies blood samples via fluid biopsy for the diagnosis of lung cancer. Studying blood samples in the laboratory may help doctors develop a blood test for lung cancer in the future and provide a better way to screen patients for lung cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma.

SECONDARY OBJECTIVES:

I. To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer.

II. To determine the relative contribution of cell based high definition circulating tumor cell assay (HD-CTC) and imaging mass cytometry (IMC) and plasma based circulating tumor deoxyribonucleic acid (ctDNA) assays in determination of diagnosis and histologic subtype.

OUTLINE:

Patients undergo collection of blood samples on day 1 for analysis via high definition (HD)-single cell analysis (SCA) fluid biopsy. Medical charts of patients are reviewed at 3 months post-biopsy or computed tomography (CT) screening.

After completion of study, patients are followed for up to 1 year.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo a diagnostic biopsy for possible lung cancer or
* Completed a diagnostic lung cancer biopsy in the prior 2 weeks and has not yet undergone treatment or
* Planning or completed in the last 2 weeks a CT lung cancer screen
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
* Known other solid tumor malignancy other than lung cancer requiring ongoing active treatment

Primary outcomes:
measure: Clinical diagnosis of lung cancer
timeFrame: Within 90 days of tissue biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Jorge J Nieva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00663078: Group Cognitive Behavioral Therapy (CBT) Intervention for Women With Mild to Moderate Depression
Official title: A Pilot Study to Develop a Brief Group Intervention for Women With Mild and Moderate Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Depression
Anxiety
Keywords: Cognitive Behavioral Therapy
expert patient programme
deprived population
women
Lead sponsor: University of Bristol
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 75
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop a structured CBT group intervention for women with depression of mild or moderate severity and to pilot a randomized controlled trial to compare this intervention with usual care in socially deprived areas in Bristol, incorporating qualitative methods to assess acceptability.


Eligibility criteria: Inclusion Criteria:

* mild to moderate depression
* antidepressant use is also OK

Exclusion Criteria:

* able to speak english
* abusing drugs or alcohol
* using secondary mental health services

Primary outcomes:
measure: PHQ-9 Score
timeFrame: 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Merrywood GP Practice Knowle West,
city: Bristol
country: United Kingdom
facility: Wellspring Healthy Living Centre
Study officials:
References:
citation: Cramer H, Salisbury C, Conrad J, Eldred J, Araya R. Group cognitive behavioural therapy for women with depression: pilot and feasibility study for a randomised controlled trial using mixed methods. BMC Psychiatry. 2011 May 13;11:82. doi: 10.1186/1471-244X-11-82.
Clinical trial NCT00549978: Safety and Pharmacokinetics of Probucol and Cilostazol
Official title: Phase IV, Safety and Pharmacokinetics of Probucol and Cilostazol When Coadministered in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Safety and Pharmacokinetics in healthy subjects
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2007-10-26
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: to investigate the safety and pharmacokinetics, in healthy adult male subjects

Detailed description: Safety and Pharmacokinetics of Probucol and Cilostazol when co-administered in Health Subjects

Eligibility criteria: Inclusion Criteria:

* Korean
* Gender: Male
* Age: Over 20 and Under 40years, at time of informed consent
* body weight: BMI over 19.0 and Under 25.0
* Subjects who meet the following criteria at the time of the screening examination
* Subjects who have given their written informed consent prior to participation in the study
* Subjects who are reliable and willing to make themselves available for the duration of the study and follow the study protocol

Exclusion Criteria:

* History or clinical evidence of significant respiratory, cardiovascular, renal, gastrointestinal, hepatic, endocrine, hematologic, neurologic, psychiatric, or other chronic disease, alcoholism, or drug abuse
* Present or previous significant drug allergy to any prescription or over the counter medication
* Blood collection exceeding 200ml within 4 weeks, 400ml within 12 weeks, or 1200ml within one year prior to scheduled study drug administration
* Body weight: under 50Kg

Primary outcomes:
measure: Pharmacokinetic parameters, Number of adverse events
timeFrame: during study follow-up period
Secondary outcomes:
measure: Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters
timeFrame: During study follow-up period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KP, Kim BH, Lim KS, Kim TE, Shin SG, Jang IJ, Yu KS. Potential interactions between cilostazol and probucol: a two-part, single-dose, open-label study in healthy Korean male volunteers. Clin Ther. 2009 Oct;31(10):2098-106. doi: 10.1016/j.clinthera.2009.10.005.
Clinical trial NCT00860678: Physical Activity in Patients After Aortic Valve Replacement (Valve-ex)
Official title: Influence of Regular Physical Activity on Exercise Capacity, Cardiac Remodeling and Endothelial Function in Patients After Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Valvular Aortic Stenosis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2009-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A structured and supervised, 3-month physical activity intervention in patients after aortic valve replacement due to severe stenosis, accompanied by examination of cardiac size and function, exercise capacity and endothelial function before, three and six months after operation; comparison with a non-intervention control group.


Eligibility criteria: Inclusion Criteria:

* Patients with severe valvular aortic stenosis and indication for valve replacement

Exclusion Criteria:

* Coronary heart disease with indication for additional bypass surgery Leading insufficiency of the valve
* Age \< 65 or \> 75
* Diseases or conditions leading to additional risks during physical activity (e.g. diabetes, arthrosis, obstructive pulmonary disease)

Primary outcomes:
measure: Maximum oxygen uptake
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Department of Prevention and Sports Medicine Technische Universität München
state: Bavaria
Study officials:
References:
citation: Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
Clinical trial NCT00812578: Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes
Official title: Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Vitamin D Insufficiency
Keywords: Type 2 diabetes
Vitamin D insufficiency
Insulin secretion
Insulin sensitivity
Pulsatility
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regionshospitalet Silkeborg
First posted: 2008-12-22
Enrollment: 16
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: BASIC_SCIENCE

Brief summary: The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D insufficiency.

Detailed description: There is increasing evidence that vitamin D affects the risk of diabetes. The role of vitamin D in type 2 diabetes is suggested by cross sectional studies, where an inverse association between vitamin D status and the development of type 2 diabetes has been found. Moreover supplementation with calcium and vitamin D may attenuate increases in glycemia and insulin resistance in healthy older adults with IFG. However further research is needed to confirm these findings and to determine possible mechanisms of the preventive effect from vitamin D against diabetes. The aim of this study is to examine the effect on metabolic parameters such as glycemic control, lipid status, inflammatory markers, insulin resistance and insulin secretion in patients with type 2 diabetes and vitamin D insufficiency before and after a 12-week period of treatment with high doses of vitamin D.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Type 2 diabetes
* Patients of Danish extraction
* Vitamin D insufficiency (1,25OHvitD \< 50 nmol/l)

Exclusion Criteria:

* Nephropathy (Urea \> 12 mmol/l)
* S-calcium \> 2,52 mmol/L
* Primary hyperparathyroidism
* Serious disease
* Malabsorption
* Sarcoidosis
* Pregnancy

Primary outcomes:
measure: Insulin secretion and insulin resistance
timeFrame: 6 hours
Secondary outcomes:
measure: Glycemic control, lipid status, inflammatory markers, BMD
timeFrame: 2 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical Research Unit, Medical Department M, Aarhus University Hospital
Study officials:
affiliation: Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
name: Lotte Oeskov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kampmann U, Mosekilde L, Juhl C, Moller N, Christensen B, Rejnmark L, Wamberg L, Orskov L. Effects of 12 weeks high dose vitamin D3 treatment on insulin sensitivity, beta cell function, and metabolic markers in patients with type 2 diabetes and vitamin D insufficiency - a double-blind, randomized, placebo-controlled trial. Metabolism. 2014 Sep;63(9):1115-24. doi: 10.1016/j.metabol.2014.06.008. Epub 2014 Jun 19.