louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05525741: Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients
Official title: Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients as Compared to Controls
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin and Connective Tissue Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with non segmental vitiligo compared to healthy volunteers (1st degree family of vitiligo patients) atopic dermatitis, psoriasis and alopecia areata patients
Primary purpose: OTHER

Brief summary: To compare the level of circulating functional mitochondria in the serum of vitiligo patients as compared to controls


Eligibility criteria: Inclusion Criteria:

* Patients with non segmental vitiligo,
* atopic dermatitis, psoriais, alopecia areata,
* 1st degree relative of vitiligo patients.

Exclusion Criteria:

* segmental or mixed vitiligo,
* personnal history of other autoimmune disorders,
* oral use of antioxidant,
* pregant women

Primary outcomes:
measure: Total number of circulating functionnal mitochondria (CFM) in the plasma
timeFrame: at baseline
Secondary outcomes:
measure: measuring the functionality of circulating mitochondria
timeFrame: At baseline
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet
state: Alpes-maritimes
Study officials:
affiliation: CHU de Nice, Service de Dermatologie
name: passeron thierry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238041: GlucoClear ICU Study
Official title: An ICU Study of Safety and Accuracy Using the GlucoClear CGM System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intensive Care Unit Blood Glucose Monitoring
Keywords: Glucose monitoring
Intensive care unit
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with an anticipated surgical lCU or surgical lCU plus intermediate care unit stay of at least 24 hours.

Brief summary: The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.

Detailed description: Design: Non-randomized, non-treatment, prospective, open label Study.

The GlucoClear System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study subjects or the Study site clinical personnel. There will be no treatment of any subject based on the output of the System.

After providing written informed consent, subjects meeting inclusion/exclusion criteria will be monitored by the System for a maximum of 72 hours.

Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose measurements on blood glucose analyzers over the 72 hour period.

After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14 days later, and any subsequent adverse events will be documented.

Eligibility criteria: Inclusion Criteria:

* 18 years Surgical ICU or surgical ICU plus intermediate care unit stay ≥ 24 hours Signed consent

Exclusion Criteria:

Transplant patient End stage medical conditions or diseases Restricted venous access History of HIT or heparin allergy Contraindication for anti-coagulation Positive pregnancy test In another study

Primary outcomes:
measure: 15/20% Accuracy
timeFrame: During 72 hours of anticipated Sensor dwell time.
Secondary outcomes:
measure: 12/15% Trend Accuracy
timeFrame: During 72 hours of anticipated Sensor dwell time.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01160341: Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism
Official title: Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism
Keywords: Metabolic syndrome
Hypogonadism
Testosterone
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2010-07-12
Enrollment: 312
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study is designed to answer the following questions:

1. Is hypogonadism a cause for the metabolic syndrome ?
2. What is the effect of testosterone replacement on the metabolic parameters ?

Detailed description: This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2002-2009.

Eligibility criteria: Inclusion Criteria:

* Men
* Congenital hypogonadism
* Treatment Naive

Exclusion Criteria:

* Previous history of androgen replacement
* Hypertension
* Diabetes mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine
Study officials:
References:
citation: Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul;60(7):762-9. doi: 10.1111/j.1742-1241.2006.00992.x.
citation: Araujo AB, O'Donnell AB, Brambilla DJ, Simpson WB, Longcope C, Matsumoto AM, McKinlay JB. Prevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 2004 Dec;89(12):5920-6. doi: 10.1210/jc.2003-031719.
citation: Saad F, Gooren LJ, Haider A, Yassin A. A dose-response study of testosterone on sexual dysfunction and features of the metabolic syndrome using testosterone gel and parenteral testosterone undecanoate. J Androl. 2008 Jan-Feb;29(1):102-5. doi: 10.2164/jandrol.107.002774. Epub 2007 Oct 3.
citation: Koesling D, Schultz G, Bohme E. Sequence homologies between guanylyl cyclases and structural analogies to other signal-transducing proteins. FEBS Lett. 1991 Mar 25;280(2):301-6. doi: 10.1016/0014-5793(91)80317-v.
Clinical trial NCT02221141: Screening of Fabry Disease in Patients With Left Ventricular Hypertrophy Detected in Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Hypertrophy
Lead sponsor: Centre Hospitalier Universitaire UCLouvain Namur
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with left ventricular hypertrophy

Brief summary: The purpose of this study is to determine the prevalence in Belgium of Fabry disease in patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to determine in Fabry patients which was the most frequently initial symptom.

Actually the early diagnosis is important because a treatment exists that can prevent future complications.


Eligibility criteria: Inclusion Criteria:

* unexplained left ventricular hypertrophy

Exclusion Criteria:

* isolated septal hypertrophy

Primary outcomes:
measure: Percentage of patients with left ventricular hypertrophy who have Fabry Disease mutation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU Dinant-Godinne
Study officials:
References:
Clinical trial NCT05982041: Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
Official title: A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammatory Myopathy
Cardiac Disease
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had a confirmed or suspected myositis

Brief summary: Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. The collection of data and biological material will mirror usual clinical practice as far as possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be collected for research purposes to measure a number of biomarkers for the assessment of diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy will be performed at baseline, and a further biopsy offered at 6 months to assess treatment response. A magnetic resonance (MR) muscle protocol will also be performed as per usual clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be repeated at 6-12 months. An existing electronic database entry system will be used for data entry and capture on an anonymised basis.


Eligibility criteria: Inclusion Criteria:

* All patients who had a confirmed (muscular biopsy, electromyogram, magnetic resonance imaging) or suspected clinically myositis
* Age over 18 years old
* Signature of the informed consent form for the study

Exclusion Criteria:

* Patients with disease duration \>2 years
* Patients \< 18 years
* Confirmed non-inflammatory myopathies
* Myositis secondary to alcohol or drug abuse
* Patients unwilling or unable to give consent
* Patients with poor or no venous access

Primary outcomes:
measure: The emergence of late gadolinium enhancement (LGE) positive in the different myositis subgroups based on radiological evaluations
timeFrame: 20 years
measure: The emergence of extra-cellular volume (ECV) > 30% in the different myositis subgroups based on radiological evaluations
timeFrame: 20 years
Secondary outcomes:
measure: Number of participants with a significant change levels of diagnostic biomarkers
timeFrame: 20 years
measure: Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls
timeFrame: 20 years
measure: Incidence of major cardio-vascular events
timeFrame: 20 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01802541: Effect of Diacylglycerol Oil on Risk Factors of Type 2 Diabetes and Complicating Disease, and Mechanism
Official title: Effect of Diacylglycerol Oil on Risk Factors of Type 2 Diabetes and Complicating Disease, and Mechanism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Type 2 Diabetes
Cardiovascular Disease
Keywords: diacylglycerol oil
insulin sensitivity
type 2 diabetes
cardiovascular disease
risk factors
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 127
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Diacylglycerol oil has been shown to lower postprandial and fasting serum triacylglycerol levels and reduce body fat. The investigators hypothesize that replacing dietary fat with diacylglycerol oil reduces excess body fat in type 2 diabetic patients and that diacylglycerol oil has a beneficial effect on cardiovascular risk factors in Chinese type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetic patients, blood sugar levels were stabilized between 7.0-10.0 mmol/L
2. Male, aged 40 - 70 years old, Female, aged post-menopausal - 70 years old.
3. Overweight/obese patients (BMI 25 - 40 kg/m2)
4. Currently under diet therapy for diabetes mellitus
5. Understands the procedures and willing to participate in the study

Exclusion Criteria:

1. Patients who unwilling to give informed consent
2. Type 1 diabetic patients
3. Familial hyperlipemia patients or blood triacylglycerol concentration \> 400 mg/dl
4. Patients with a history of cardiovascular disease and/or arteriosclerotic disease
5. Patients with a history of cerebrovascular disease
6. Patients with serious hepatic disease and/or renal disease
7. Patients with malignancy
8. Participation in another clinical study within 30 days prior to screening period.
9. Has a condition the doctor in charge believes would interfere with evaluation of the subject, or may put subject at undue risk

Primary outcomes:
measure: insulin resistance
timeFrame: 120 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Duo Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00432341: Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Spasmodic Torticollis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-02-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
* Successfully treated previously with botulinum toxin type A

Exclusion Criteria:

* Breast feeding, pregnant, or could become pregnant
* Surgery or spinal cord stimulation for cervical dystonia
* Previous injections of phenol, alcohol for cervical dystonia

Primary outcomes:
measure: Duration of Treatment Benefit
timeFrame: 20 Weeks
Secondary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4
timeFrame: Week 4
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
timeFrame: Baseline, Week 4
measure: Global Assessment of Benefit by Patient at Week 4
timeFrame: Week 4
measure: Global Assessment of Benefit by Physician at Week 4
timeFrame: Week 4
measure: Physician Assessment of Cervical Dystonia Severity at Week 4
timeFrame: Baseline, Week 4
measure: Physician Comparison of Benefit to Previous Injections at Week 20
timeFrame: Week 20
measure: Patient Comparison of Benefit to Previous Injections at Week 20
timeFrame: Week 20
measure: Patient Visual Analog Assessment of Pain at Week 4
timeFrame: Baseline, Week 4
measure: Patient Assessment of Need for Retreatment at Week 4
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Parkville
country: Australia
state: Victoria
city: New Delhi
country: India
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02616341: Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder
Official title: Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-11-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of this study is to determine modifications to Exposure and Response Prevention (ERP) therapy that are needed in order to effectively deliver treatment for Obsessive Compulsive Disorder (OCD) in a community mental health center. This study is the final study in a series of three projects executed to adapt and pilot-test a team ERP (T-ERP) intervention that will optimize therapist time by utilizing paraprofessionals to assist with group-ERP treatment plans. The intervention will be tailored to meet the unique needs of low-SES individuals with OCD and be implemented in a community mental health center (CMHC).


Eligibility criteria: Inclusion Criteria:

1. 18 Years to 65 Years
2. English speaking
3. Primary DSM-IV OCD (identified by the patient and therapist as the most problematic disorder over the past year)
4. At least moderate severity OCD (YBOCS \> 16)
5. Not currently on psychotropic medications or on the same psychotropic medications for at least 4 weeks prior to screening
6. Have never received 10 or more sessions of ERP
7. Not currently attending psychotherapy for OCD
8. Low-income based on the U.S. Housing and Urban Development (HUDs) threshold for RI (less than $41,000 per year for individuals).

Exclusion Criteria:

1. Significant cognitive impairment (MMSE \< 25)
2. Prominent suicidal ideation
3. Current psychosis, mania, alcohol or drug dependence as assessed by the SCID-P.
4. Prominent Hoarding

Primary outcomes:
measure: Changes in OCD symptom severity as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Baseline, 6th week of treatment, 12th week of treatment, 3 months post-treatment, 6 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Butler Hospital, Providence RI 02906
name: Maria Mancebo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02639741: Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia
Official title: Comparison Of The Effects Of Preoperative Melatonin Or Vitamin C Administration On Postoperative Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Melatonin
Vitamin C
Morphine consumption
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2015-12-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery.

Detailed description: The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery. One hundred-sixty five ASA I-II adult patients between 18-65 years of age, undergoing elective major abdominal surgery with general anesthesia will be included in this double blinded, randomised, controlled study. Patients will randomly divided into equal (n=55) three groups. Preoperatively, one hour before surgery, patients will receive melatonin (6 mg) in group M, vitamin C (2 gr) in group C or placebo tablet in group P orally. A standard anesthetic protocol will be administered to all patients. At the end of surgery, postoperative pain control will be provided via a patient controlled analgesia (PCA) device including morphine in all groups. Hemodynamic parameters, pain, sedation, patient satisfaction, total morphine consumption, supplement analgesic requirement, incidence of nausea and vomiting and other side effects will be recorded at 5, 10, 30 min and 1, 2, 4, 6, 8, 12, 24 hr after surgery.

Eligibility criteria: Inclusion Criteria:

Patients undergoing elective major abdominal surgery with general anesthesia

Exclusion Criteria:

A history of psychiatric disorders, chronic pain syndromes, obstructive sleep apnea, severe asthma, chronic obstructive pulmonary disease, congestive heart failure, hepatic or renal failure, patients with pregnancy or in lactation period or a history of allergic reaction to any drugs

Primary outcomes:
measure: morphine consumption at 24 hours after surgery.)
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Hakkı Ünlügenç
Study officials:
affiliation: Cukurova University
name: Hakkı Ünlügenç, Prof Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04533841: Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor in Primigravidas
Official title: Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor In Primigravidas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2020-09-01
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial
Primary purpose: TREATMENT

Brief summary: To compare propranolol and misoprostol versus misoprostol alone for induction of labour in primigravidas

Detailed description: Candidates will be randomized into 2 groups according to a computer generated sequence. Each candidate will be assigned an opaque sealed envelope containing a paper with her group on it. Both the patient and doctor on duty will be blinded to which group the patient was assigned to.

- Study procedure:

1. Written informed consent will be obtained from all participants prior to the study.
2. Full history taking.
3. General examination.

Patients will be subjected to the following:

* Patients attending labour room for induction of labour will be divided into two groups.
* Both groups, women are induced with Tab misoprostol 25μg applied to posterior vaginal fornix under aseptic precaution and every 6 hours for a maximum of 4 doses.
* In group 1, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral Propanolol 20mg
* In group 2, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral placebo in the form of sugary tablets.
* After induction, women will be monitored for fetal and maternal wellbeing and progress of labour.

Eligibility criteria: Inclusion Criteria:

* • Primigravidas.

  * Full term patients with ultrasound confirmed dates.
  * Singleton.
  * Cephalic presentation.
  * Fetal heart rate between 120 to 160 beats per minute.

Exclusion Criteria:

* • Any history of previous surgery on the uterus.

  * Patients in active labour, with ruptured membranes.
  * Fetal distress.
  * Macrosomia or polyhydramnios
  * Hypersensitivity to prostaglandins.
  * Asthmatic patient .
  * liver or kidney impairment .
  * known cardiac patient with abnormal ECG.

Primary outcomes:
measure: Induction delivery interval
timeFrame: procedure delivery
Secondary outcomes:
measure: Mode of delivery
timeFrame: delivery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Ahmed mohamed fathy ismail
state: El Sharquia
Study officials:
affiliation: Ain Shams University
name: Ahmed S Abd El hamid, A.professor
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Hazem A Hassan elzeneiny, Professor
role: STUDY_DIRECTOR
References: