louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03814174: Comparison of Physical Fitness and Activities of the Children With Epilepsy and Their Healthy Peers
Official title: Comparison of Physical Fitness and Activities of the Children With Epilepsy and Their Healthy Peers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Physical Activity
Keywords: Childhood Epilepsy
Physical Fitness
Physical Activity
Use of Pedometer
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of children with epilepsy and their healthy peers.

Brief summary: To investigate physical fitness and activity levels in children with epilepsy and compare the results with healthy peers.

Detailed description: Many individuals with epilepsy are physically inactive due to the fear of seizures triggered by physical activity/ exercise, and the advices given by the family members and the health care professionals to avoid intense activity . In two studies performed about this subject, this is the probable reason why adult patients with epilepsy have a weaker physical fitness than healthy individuals in the control group. However; in a study of Drawskowski et al., the avoidance of activity and exercise in individuals with epilepsy was investigated, and it was reported that the injuries and seizure problems were rare even during very intense physical activity.

Eligibility criteria: Inclusion Criteria:

* children who were diagnosed with epilepsy
* children who can independently continue formal education,
* children who do not need special education
* children who have no additional neurological and neuromuscular disease (epilepsy only)
* children who have a normal or higher cognitive level according to the WISC-R intelligence test
* children who were volunteers to participate in the study
* children whose parents volunteers to participate in the study

Exclusion Criteria:

* The disappearance of volunteerism

Primary outcomes:
measure: Number of steps on pedometer
timeFrame: seven days
measure: Exercise performance using 6-minute walk test
timeFrame: 1st day (before using device)
measure: Health-Related Physical Fitness Test for body compozition
timeFrame: 1st day (before using device)
measure: Health-Related Physical Fitness Test for strenght
timeFrame: 1st day (before using device)
measure: Health-Related Physical Fitness Test for balance
timeFrame: 1st day (before using device)
measure: Health-Related Physical Fitness Test for flexibility
timeFrame: 1st day (before using device)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT00998374: Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
Official title: Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoglycemia
Obesity
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients \>18 years of age BMI greater than or equal to 35

Brief summary: This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.

Detailed description: Clinical Trial Objective:

The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate.

Clinical Trial Design:

This is a prospective, non-randomized, clinical trial.

Eligibility criteria: Inclusion Criteria:

* The patient is greater than 18 years old;
* The patient has a BMI \> 35;
* Patient meets standards for bariatric surgery;

Exclusion Criteria:

* The patient has an incurable malignant or debilitating disease;
* The patient has been diagnosed with a severe eating disorder;
* The patient is currently pregnant (pregnancy test required for confirmation for those of child bearing years);
* The patient is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent

Primary outcomes:
measure: Mean Serum Glucose Levels
timeFrame: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively
measure: Reactive Hypoglycemia Status
timeFrame: 6 months, 9 months, 12 months post-op
Secondary outcomes:
measure: Insulin Resistance
timeFrame: 6, 9, and 12 months post-operatively
measure: Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing
timeFrame: 6, 9, and 12 months post-op
Other outcomes:
Locations:
city: New York City
country: United States
facility: Lenox Hill Hospital 186 E76th Street, 1st Floor
state: New York
Study officials:
affiliation: Lenox Hill Hospital
name: Mitchell Roslin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03625674: Impact of Stigma on Compliance to Medication in Functional Dyspepsia
Official title: Impact of Stigma on Compliance to Medication in Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Adherence, Patient
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, no study exists that evaluates whether functional dyspepsia patients experience stigma and how stigma may influence adherence. Thus, the investigators aim to evaluate the relationship between functional dyspepsia and stigma, and explore possible ways to improve treatment adherence.

Detailed description: Due to the functional but refractory nature of functional gastrointestinal diseases (FGIDs), large number of patients who suffer from FGIDs may not be able to fully understand their diagnosis, especially when they were told that they had no organic disease and their symptoms had a psychosomatic origin rather than a gastrointestinal one. Moreover, subjects with FGIDs have concerns and negative perceptions about medications, particularly in the presence of psychiatric comorbidity. Fearing of being labeled as insane or incapability, many patients with psychosomatic symptoms choose to conceal their illness to family, colleagues and doctors. These factors may affect willingness to initiate neuromodulator regimens and treatment adherence.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old;
* met the ROME IV criteria for FD;
* absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months;
* absence of H. pylori infection;
* Generalized Anxiety Disorder Scale (GAD-7) ≥ 1 or Patient Health Questionnaire Depression Scale (PHQ-9) ≥ 5

Exclusion Criteria:

* any evidence of organic digestive diseases;
* other FGIDs such as IBS;
* severe psychological symptoms with GAD-7 ≥ 11 or PHQ-9 ≥15;
* pregnancy or breastfeeding; recent myocardial infarction or cardiac arrhythmias;
* previous gastric surgery;
* use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months

Primary outcomes:
measure: compliance of psychoactive medicine
timeFrame: week8
Secondary outcomes:
measure: stigma scale
timeFrame: week 0
measure: dyspepsia symptom score
timeFrame: week 2, week 4, week 6, week8
measure: anxiety symptom scores
timeFrame: week 2, week 4, week 6, week8
measure: depression symptom scores
timeFrame: week 2, week 4, week 6, week8
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJiH
Study officials:
References:
citation: Yan XJ, Luo QQ, Qiu HY, Ji CF, Chen SL. The impact of stigma on medication adherence in patients with functional dyspepsia. Neurogastroenterol Motil. 2021 Feb;33(2):e13956. doi: 10.1111/nmo.13956. Epub 2020 Jul 27.
Clinical trial NCT03156374: Timing Frozen Embryo Transfer by Following Two Different Methods
Official title: Proof of Concept Study To Assess Women's Likability and Stress in Timing Frozen Embryo Transfer by Following Two Different Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Disorders
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2017-05-17
Enrollment: 46
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Parallel use of ovulation test and standard hospital monitoring, for agreement of methods
Primary purpose: DIAGNOSTIC

Brief summary: This proof of concept study is designed to determine the practicality of using home ovulation tests to enable optimum timing for transfer of frozen embryos in a natural menstrual cycle in comparison to the standard ultrasound and serum monitoring currently conducted by many IVF clinics.

Detailed description: The study will evaluate the ability of home ovulation tests to accurately time Frozen Embryo Transfer (FET) directly compared to standard clinical procedures. In addition, women's likability and stress associated with timing a FET cycle using both methods will be evaluated by collecting qualitative data using standardised questionnaires.

The impact of psychological stress on FET outcome such as implantation rates and viability at first scan will be considered in order to gather information for the design of a larger clinical study and basic financial data will also be collected, in order to pilot a cost-effectiveness evaluation of the two FET timing methods.

A subset of volunteers will collect daily urine samples from day after embryo transfer until confirmation of pregnancy.

Eligibility criteria: Inclusion Criteria:

* Women aged 24 to 45 years of age
* Undergoing no more than 5frozen embryo transfer
* Average cycle length between 26 and 35 days
* Willing to provide written informed consent to participate in the study and comply with all study procedures

Exclusion Criteria:

* More than five IVF frozen embryo cycle
* Undergoing FET following cancer treatment
* Self-reported drug or alcohol dependency
* Self-reported history of depression, anxiety and panic attacks

Primary outcomes:
measure: Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit
timeFrame: 9 months
Secondary outcomes:
measure: Measurement of women's psychological distress
timeFrame: 9 months
measure: Positive and negative experience in using ovulation tests in FET
timeFrame: 9 months
measure: FET success
timeFrame: 9 months
Other outcomes:
Locations:
city: Bondi Junction
country: Australia
facility: IVFAustralia - Bondi Junction
state: New South Wales
Study officials:
References:
Clinical trial NCT02835274: Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation
Official title: Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: parkinson disease
deep brain stimulation
directional stimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-07-18
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
* UPDRS III score of \>25 in the meds OFF condition
* Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score

Key Exclusion Criteria:

* Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
* Any current drug or alcohol abuse as determined by the investigator
* Any history of recurrent or unprovoked seizures
* Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months

Primary outcomes:
measure: Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
timeFrame: Up to 12 months post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble - Hopital Michallon
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References:
Clinical trial NCT00913874: To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions
Official title: A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Bipolar Disorder
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Xueya (Eric) Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730574: Examining B12 Deficiency Associated With C677T Mutation on MTHFR Gene in Terms of Commonness and Endothelial Function
Official title: Examining the Commonness of the C677T Mutation in the MTHFR Gene in Subjects With B12 Deficiency and the Influence of the B12 Deficiency Combined With the C677T Mutation on the MTHFR Gene on Endothelial Function.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: B12 Deficiency Combined With C677T Mutation on MTHFR Gene
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine the commonness of the C677T mutation in the MTHFR gene in subjects with B12 deficiency. Also, we'd like to investigate the effect of B12 deficiency combined with the C677T mutation on endothelial function.

Detailed description: we showed that patiebts with B12 deficiency have higher than expected frequency of MTHFR mutation and patients with both abnormalities havean abnormal endothelial function

Eligibility criteria: Inclusion Criteria:

1. adult males and females of the broad population aged 20-60
2. with no symptomatic heart disease/condition
3. with Vitamin B12 levels of 150 pmol or less
4. which have not received Vitamin B12 supplement treatment before

Exclusion Criteria:

1. Adults suffering from a known heart disease/condition
2. any disease the investigator might find as interfering with the process of the experiment
3. tumor-oriented diseases

Primary outcomes:
measure: The primary measure to determine the effect of the treatment will be reduced levels of Homocysteine in subjects with B12 deficiency combined with C677T mutation in the MTHFR gene.
timeFrame: The key measure would be measured upon enrollment and 6 weeks afterwards, upon completion of treatment based on 1mg Vitamin B12 sublinual and 5 mg Folic Acid per day.
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center, Haifa, Israel
name: Moshe Y Flugelman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01636674: 18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon Cancer
Official title: Value of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography and Molecular Tumor Characterisation in Preoperative Staging og Postoperative Control of Colon Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: positron emission tomography
computed tomography
fluordeoxyglucose
colon cancer
cancer
staging
imaging
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Rigshospitalet, Denmark
name: Region Zealand
First posted: 2012-07-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators are investigating the usefulness of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography (18F-FDG PET/CT) for staging and follow-up of colon cancer. Furthermore, the investigators combine 18F-FDG PET findings with clinical and histopathological features, circulating tumor cell (CTC) analyses, tumor gene expression and measurements of circulating cancer biomarkers sUPAR, TIMP-1 and CEA in order to predict tumor recurrence.

The investigators hypothesis: The combination of functional imaging by 18F-FDG PET/CT and pre-existing and evolving molecular biomarkers will optimize tumor characterization, staging of disease and early detection of recurrence.


Eligibility criteria: Inclusion Criteria:

* clinical or histological diagnosis of malignant clonic neoplasm (distance of more than 15 cm from anal ring)
* 18 years of age or older
* written informed consent

Exclusion Criteria:

* diabetes
* known malignant disease other than colon cancer
* known metastatic disease
* impairment of renal function
* allergy to CT contrast agents
* body weight of more than 150 kg
* claustrophobia

Primary outcomes:
measure: time to recurrence
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Naestved Hospital
name: Bodil E Engelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01650974: High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy
Official title: High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy: A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Keywords: high flow nasal oxygen therapy
diagnostic bronchoscopy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 136
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.

Detailed description: Hypoxemia is frequently seen during diagnostic bronchoscopy. Nasal prong or other existing oxygen supply methods are often difficult to maintain adequate oxygenation during bronchoscopy. In particular, bronchoscopy to patients already showing hypoxemia can be dangerous even though applying conventional oxygen therapy. Thus, we want to elucidate the usefulness of nasal high flow oxygen therapy to hypoxemic patients undergoing diagnostic bronchoscopy.

Eligibility criteria: Inclusion Criteria: 1 or 2

1. PaO2 \< 60 mmHg on ABGA or SpO2 \< 90 % in room air AND SpO2 ≥ 95% or PaO2 ≥ 75mmHg in low flow oxygen therapy
2. Planning to diagnostic bronchoscopic procedure (e.g. bronchial washing, BAL, bronchoscopic biopsy, EBUS-TBNA etc.)

Exclusion Criteria:

1. patients who did not agree to provide information
2. patients requiring for emergent intubation
3. patients can not wear or be already applied high flow nasal oxygen therapy
4. patients with unstable vital sign(e.g. severe hypotension, uncontrolled arrhythmia, etc.)
5. patients with multiple organ failures
6. patients with plan to therapeutic bronchoscopic procedure(e.g. intervention)

Primary outcomes:
measure: Success rate of bronchoscopy
timeFrame: 1 day
measure: Total duration of hypoxia
timeFrame: 1 day
Secondary outcomes:
measure: frequency of hypoxia
timeFrame: 1 day
measure: switch to oxygen therapy method
timeFrame: 1 day
measure: change of respiratory symptoms
timeFrame: 1 day
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Young-Jae Cho, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: