louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00969007: Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects
Official title: Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Obesity
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: The Lawson Foundation
First posted: 2009-08-31
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to identify baseline and early predictors of favorable and unfavorable response to lifestyle intervention. As a secondary objective, the investigators would like to validate our questionnaire or other identified predictors as clinical tools to guide us in selection of the most suitable candidates for lifestyle intervention programs. Assuming the same capacity of our questionnaire to predict an absence of weight loss (≥5%) or a loss to follow-up (likelihood ratio for a positive test, LR+ = 9.9), 70 subjects need to be included in this study in order to find a lower limit of the 95% confidence interval above 2.0 for this LR+, which is the limit of an acceptable test. The investigators will enroll participants with pre-diabetes and BMI 27-40 in our program and administer to them at baseline and at 3 months the designed questionnaire, as well as other already well validated questionnaires assessing state of change and readiness to implement diet or exercise modifications.


Eligibility criteria: Inclusion Criteria:

* BMI between 27-40 kg/m2
* impaired glucose tolerance, confirmed by an oral glucose tolerance test (OGTT = fasting glucose lower than 7.0 mmol/l and glucose 2 hours post 75g of glucose between 7.8-11.0 mmol/l), or impaired fasting glucose (6.1-6.9 mmol/L)
* 18 years old or more
* Being able to read and give an informed consent

Exclusion Criteria:

* Conditions that affects weight or glucose metabolism

Primary outcomes:
measure: 5% weight loss
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Marie-France Langlois
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Jean-Patrice Baillargeon, MD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05626907: Does What You Eat Affect Your Brain
Official title: Assessing the Effect of Diet on Hypothalamic Gliosis in Humans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gliosis
Obesity
Eating
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-11-25
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to use magnetic resonance imaging (MRI) to evaluate the human hypothalamus for signs of inflammation in response to specific diets. This research may lead to a better understanding of how poor nutritional quality may lead to obesity through effects on regions of the brain known to regulate body weight.


Eligibility criteria: Inclusion Criteria:

* Age 20-40 years
* Overweight: BMI 25-29.9 kg/m2
* Willing to undergo randomly assigned 14-day diet modification

Exclusion Criteria:

* History of bariatric surgery or active participation in weight-loss program
* Major medical or neurological disorder (e.g., diabetes, multiple sclerosis)
* Anemia or impaired kidney or liver function
* Known gallbladder disease or gallstones
* Hypertriglyceridemia (\>350 mg/dl)
* Current use of orlistat or other weight-loss medications or other medications known to alter appetite (e.g., atypical anti-psychotics)
* More than moderate level of physical activity (\>1000 met-min/wk)
* Pregnancy, menopause, or breastfeeding
* MRI contraindication (e.g., implanted metal, claustrophobia)
* Lifetime eating disorder
* Current smoking or heavy alcohol use (≥ 2 drinks per day for females and ≥ 3 drinks per day for males)
* Weight \> 350 pounds (MRI limit)
* Dietary restrictions (e.g., vegan) incompatible with controlled diets

Primary outcomes:
measure: Hypothalamic Gliosis
timeFrame: 7 days of diet intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ellen A Schur, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01734707: Atherosclerosis Monitoring and Atherogenicity Reduction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carotid Atherosclerosis
Keywords: atherosclerosis
regression
Allicor
garlic
intima-media thickness
Lead sponsor: Institute for Atherosclerosis Research, Russia
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 300
Sex: MALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to estimate the effect of two-year treatment with time-released garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial.


Eligibility criteria: Inclusion Criteria:

* Men aged 40 to 74 years
* Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 mcm)
* Arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm Hg, diastolic blood pressure \<90 mm Hg)
* Absence of chronic diseases demanding permanent drug administration (more than 2 month per year)

Exclusion Criteria:

* Personal history or diagnostic of following diseases:

  1. Transient ischemic attacks
  2. Presence of chronic diseases demanding permanent drug administration (more than 2 month per year)
  3. Condition of patients moderate to severe
* Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system.
* Individual intolerance of Allicor or appearance of side effects

Primary outcomes:
measure: high-resolution B-mode ultrasonography of common carotid arteries
timeFrame: up to 2 years
Secondary outcomes:
measure: Measure of serum atherogenicity
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Atherosclerosis Research
Study officials:
References:
citation: Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.
Clinical trial NCT05676307: Vestibular Rehabilitaion in Bilateral Vestibular Hypofunction
Official title: ETIOLOGICAL FACTORS AND EFFECT OF VESTIBULAR REHABILITATION ON BILATERAL VESTIBULAR HYPOFUNCTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Vestibular Loss
Vestibular Rehabilitation
Lead sponsor: Istanbul Gedik University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 is to determine the etiological factors that constitute bilateral vestibular hypofunction and to investigate the effect of vestibular rehabilitation in these patients.

The Caloric test and Video Head Impulse test were applied to evaluate the vestibular hypofunction picture of the patients who applied to Clinic with complaints of vertigo, dizziness and imbalance. Among these patients with BVH, those with vestibular symptoms, imbalance complaints and limited daily living activities were included in rehabilitation. In order to investigate the effectiveness of rehabilitation, oculomotor functions were evaluated using Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System, balance assessment was done with timed balance tests and quality of life assessment was performed with Dizziness Handicap Inventory.


Eligibility criteria: Inclusion Criteria:

* Patients between 18-70 years of age with bilateral vestibular hypofunction and peripheral vestibulopathy

Exclusion Criteria:

* Patients with unilateral vestibular hypofunction, cerebellar lesion, and cognitive problems were excluded from the study.

Primary outcomes:
measure: Evaluation of Oculomotor Activity (Saccade Frequency Level)
timeFrame: 8 week
measure: Quality of Life Assesment
timeFrame: 8 weeks
measure: Static Balance Tests
timeFrame: 8 weeks
measure: Evaluation of Oculomotor Activity (Pursuit Frequency Level)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli̇
country: Turkey
facility: Gönül Ertunç Gülçelik
Study officials:
References:
Clinical trial NCT03275207: Dexmedetomidine for Prevention of Chronic Postoperative Pain
Official title: a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Postoperative Pain
Keywords: Chronic pain
CPSP
Dexmedetomidine
Surgery
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: paitents undergoing breast or thoracic surgery
Primary purpose: PREVENTION

Brief summary: Chronic postoperative pain (CPSP) is common symptom in patients after surgery, seriously affected the quality of life. Accumulating evidences have demonstrated dexmedetomidine can improve chronic pain. However, the prevention of dexmedetomidine on CPSP remain uncertain.

Detailed description: Chronic postoperative pain (CPSP) is defined as pain persisting at least 3 months after surgery. It is most common in patients who undergoing breast or thoracic surgery. Dexmedetomidine, a adrenergic α2 agonists, can alleviate the postoperative pain 24 h after surgery. In our study, patients were randomly assigned to one of the two group to receive 0.5mg/kg/h infusion dexmedetomidine (Group D, n=57) or normal saline (Group C, n=57). The pain scales were evaluated day 1, day 2, day 3, month 3, month 6 after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery.

Exclusion Criteria:

* Patients with limitations of self-expression or visual dysfunction or having emergency surgery, a severe psychiatric illness, or chronic pain problems in the chest area for longer than 2 months before the surgery,or patients who could not provide informed consent were excluded.
* Pregnant women and prisoners were also excluded.

Primary outcomes:
measure: the pain intensity measure
timeFrame: 12 months
Secondary outcomes:
measure: anxiety
timeFrame: 12 months
measure: depression
timeFrame: 12 months
measure: sleep disturbance
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Yang Jian-jun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00720707: Coronally Advanced Flap in Combination With Acellular Dermal Matrix and Enamel Matrix Derivatives for Root Coverage
Official title: Coronally Advanced Flap in Combination With Acellular Dermal Matrix With or Without Enamel Matrix Derivatives for Root Coverage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingival Recession
Keywords: Coronally advanced flap
gingival recession
enamel matrix protein
acellular dermal matrix
root coverage
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical outcomes of root coverage procedures, using coronally advanced flap in combination with acellular dermal matrix with or without enamel matrix derivatives .

Detailed description: coverage of gingival recession defects has been considered as a matter of interest for dental practitioners.subjects with a paired gingival recession defect will be selected from the patients who sought dental treatment at our department.Random allocation of the treatment sites to test (CAF+ EMD+ADM) and control (CAF + ADM) groups will be performed by a person who is external to the study and using a computerized selection of random numbers for allocation of the study groups.The parameters of the study are as following items: probing depth( PD), clinical attachment level (CAL), width of keratinized tissue (WKT), recession depth from cemento- enamel junction (RD), recession width (RW), distance between mucogingival junction and the stent (MGJ), Plaque (PI) and gingival (GI) indices and root coverage percentage (RC) and the patients will be followed up for 6 months.

Eligibility criteria: Inclusion Criteria:

* Having no systemic disease affecting the periodontium,
* No contraindication for elective surgery,
* Adequate oral hygiene ,
* No previous surgical attempts for root coverage at the studying sites,
* Vital teeth and signing a witness letter.

Exclusion Criteria:

* Smoking, presence of a restorations on tooth surface for test and control teeth,
* Pregnancy,
* Being under treatment with steroids,
* Peri-apical infection,
* Indication for antibiotic prophylaxis prior to dental treatments

Primary outcomes:
measure: the percentage of root coverage
timeFrame: at baseline, 2 and 6 months after treatment.
Secondary outcomes:
measure: clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Faculty of Dentistry- Tabriz University of Medical Sciences
state: East Azerbaijan
Study officials:
affiliation: Tabriz University (Medical Sciences)
name: Reza Pourabbas, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04364607: IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia
Official title: Intramuscular Neostigmine for Accelerating Bladder Emptying After Cesarean Section by Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section Complications
Keywords: Cesarean Section
Spinal anesthesia
Postoperative urine retention (POUR)
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the efficacy of IM neostigmine (0.5 mg) for acceleration of bladder evacuation and prevention of postoperative urine retention following cesarean delivery carried out under spinal anesthesia

Detailed description: Following cesarean delivery, women will receive either 0.5 mg IM neostigmine (study group) or IM NaCl 0.9% (control group). Bladder ultrasonography will be done every hour until spontaneous voiding occurs. If postoperative urine retention occurred (void inability with bladder volume \> 600 ml by ultrasound), urinary catheterization will be done.

Eligibility criteria: Inclusion Criteria:

* Pregnant women undergoing elective cesarean deliver under spinal anesthesia.

Exclusion Criteria:

* The age of the patient is more than 35 years of less than 20 years.
* The body mass index of the patient is more than 35 kg/m2 or her height is more than 180 cm or less than 150 cm.
* Multiple gestation.
* The patient is in active labor.
* Vaginal bleeding, placenta previa or abruption of the placenta.
* Presence of fetal distress.
* Urinary symptoms.
* Medical disorders co-existing with or complicating pregnancy.
* Contraindications for or history of adverse reaction of Neostigmine.
* Contraindication for spinal anesthesia.
* Refusal of the patient to receive spinal anesthesia.
* Intraoperative significant hemorrhage.
* Duration of the operation is more than one hour.
* Occurrence of postoperative complications as eclampsia.

Primary outcomes:
measure: Time to first voiding after treatment
timeFrame: Until 12 hours postoperatively
measure: Time to first voiding after catheter removal
timeFrame: Until 12 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Aml M Aljaml
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed A Elnegery, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Nermeen M Shams-Eldien, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Khalid Samir, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01901107: Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
Official title: Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphataemia Receiving Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis
Keywords: Hemodialysis
CKD (chronic kidney disease)
ASP1585
Hyperphosphatemia
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-07-17
Enrollment: 1078
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic renal failure patients with hyperphosphataemia receiving hemodialysis

Brief summary: The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Detailed description: Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.

Eligibility criteria: Chronic renal failure patients with hyperphosphataemia receiving hemodialysis

Primary outcomes:
measure: Safety assessed by the incidence of adverse events, physical exam and lab-tests
timeFrame: for one year
Secondary outcomes:
measure: Serum phosphate level
timeFrame: Baseline and 1, 2, 3, 6, 12 months after administration
measure: Serum calcium level
timeFrame: Baseline and 1, 2, 3, 6, 12 months after administration
measure: Intact PTH (parathyroid hormone) level
timeFrame: Baseline and 1, 2, 3, 6, 12 months after administration
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kantou
country: Japan
city: Kinki
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT05541107: Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
Official title: Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cryptococcal Meningitis
Lead sponsor: Matinas BioPharma Nanotechnologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Minnesota
First posted: 2022-09-15
Enrollment: 270
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 pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).

Detailed description: Pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy. Randomization will by 1:1:1 to one of two experimental arms or standard of care.

Eligibility criteria: Inclusion Criteria:

* CSF cryptococcal antigen (CrAg) positive meningitis
* Ability and willingness to provide informed consent
* Willing to receive protocol-specified lumbar punctures

Exclusion Criteria:

* Glasgow Coma Scale \< 15 at time of consent
* Received \>= 3 doses of amphotericin B within prior 30 days
* Inability to take enteral (oral or nasogastric) medicine
* Cannot or unlikely to attend regular clinic visits
* Receiving chemotherapy or corticosteroids
* Suspected paradoxical immune reconstitution inflammatory syndrome (IRIS)
* Pregnancy or breastfeeding
* Previous administration of MAT2203
* Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments

Primary outcomes:
measure: Survival
timeFrame: 2 weeks
Secondary outcomes:
measure: Meningitis-free survival
timeFrame: 10 weeks
measure: Evidence of fungicidal activity
timeFrame: 2 weeks
measure: CSF culture sterility
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: David R Boulware, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Diseases Institute
name: David B Meya, MBChB
role: PRINCIPAL_INVESTIGATOR
References: