louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02314598: Therapy Coil Electrogram Collection Study
Official title: Therapy Coil Electrogram Collection Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lead Insulation Failure
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 46
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: Patients with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device followed-up at community hospitals

Brief summary: This is a prospective, non-randomized, multicenter, post market release study which will collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the high voltage portion of the defibrillator lead and will evaluate the electrogram signals.


Eligibility criteria: Inclusion Criteria:

* Subject is willing to sign and date the study Informed Consent form
* Subject is at least 18 years of age (or older, if required by local law)
* Subject is willing and able to wear a Holter monitor for up to 24 hours
* Subject has been implanted with a Medtronic ICD or CRT-D device
* Subject has an increased risk of lead insulation breach

Exclusion Criteria:

* Subject has medical conditions that would limit study participation
* Subject is enrolled in one or more concurrent studies that would confound the results of this study

Primary outcomes:
measure: Number of Patients With Abnormal Electrograms During a Lead Issue
timeFrame: 24 hours
Secondary outcomes:
measure: Proportion of Patients With Abnormal Electrograms and Lead Failure
timeFrame: 1 month
measure: Additional Abnormal Electrogram Characteristics
timeFrame: 1 month
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
facility: SUSCCH
city: Bratislava
country: Slovakia
facility: NUSCH
Study officials:
References:
Clinical trial NCT01726998: Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparetic Patients After Subacute Stroke
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted locomotor training on motor recovery of lower extremities and walking ability compared with the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.

72 first-ever stroke patients who could not walk independently (FAC \< 2), and suffered within 6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk independently before stroke attack were excluded.

Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment (NDT) basically. The robotic assisted locomotor training group received additional robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3), Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA), Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles were assessed before, during (2weeks) and after training. And the independent walking ability were followed until 3 months.


Eligibility criteria: Inclusion Criteria:

1. Hemiparesis as result of 1st stroke
2. No other neurologic or orthopedic disorder
3. Independent ambulation before the stroke
4. No severe medical illnesses
5. Hemiparesis: lower extremity strength graded ≤ 3 in more than 2 muscle groups
6. Functional ambulation classification (FAC) ≤ 1 : indicating a need for personal assistance in ambulation
7. The interval between stroke and start of the treatment
8. Time since stroke onset \< 6 months
9. age: 20-80yrs old

Exclusion Criteria:

1. Unstable fractures
2. Severe osteoporosis
3. Severe skin problems
4. Severe joint problems
5. Major difference in leg length,
6. Body weight over 130 kg,
7. Orthostatic circulatory problem
8. Severe cognitive impairment

Primary outcomes:
measure: change of functional ambulation category point
timeFrame: baseline, during training (2weeks), post training (4weeks) & followed for 2months after training
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT06639698: Treatment of Women with PCOS of Phenotype D
Official title: Treatment of Menstrual Cycle Alterations in Women with PCOS of Phenotype D Using Dietary Supplementation That Combines Diosgenin, Vitamin D and Alpha-lactalbumin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PCOS (Polycystic Ovary Syndrome)
Keywords: PCOS phenotype D
Diosgenin
Dioscorea
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, female patients diagnosed with PCOS of phenotype D will be enrolled. They generally display the following characteristics: menstrual cycle alterations; polycystic ovary morphology at ultrasound; normal blood levels of androgen, particularly testosterone; no signs of clinical hyperandrogenism.

Current treatments for this condition include insulin sensitizers (such as metformin) and hormonal contraceptives. However, this specific phenotype of PCOS do not feature metabolic or hormonal alterations, and the efficacy of these treatments has lately been questioned.

In the present clinical trial, patients will be given a dietary supplement containing Dioscorea extract (source of Diosgenin, a natural analog of progesterone), vitamin D and alpha-lactalbumin for six month. Restoration of regular menstrual cycle and physiological ultrasound appearance of the ovaries will be the primary goal of the intervention.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PCOS of phenotype D, according to the Rotterdam Criteria and the EGOI-PCOS Criteria

Exclusion Criteria:

* Diagnosis of PCOS of phenotype A, B or C, according to the Rotterdam Criteria and the EGOI-PCOS Criteria
* Hormonal treatments;
* Treatments with inositol or other insulin sensitizers (such as metformin);
* Insulin resistance or pre-diabetes condition
* BMI \> 30
* Endocrinological alterations
* Chronic pharmacological therapies
* Major pathological conditions (e.g. tumors or autoimmune diseases)

Primary outcomes:
measure: Restoration of regular menstrual cycle
timeFrame: From enrollment (T0) to the completion of the study at 6 months (T6M)
Secondary outcomes:
measure: Restoration of physiological appearance of the ovaries at ultrasound
timeFrame: From enrollment (T0) to the completion of the study at 6 months (T6M)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Alma Res Fertility Center
state: ITA
Study officials:
References:
Clinical trial NCT04788498: Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy
Official title: Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Presumed Benign Ovarian Cystectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Cyst Benign
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work is to evaluate the postoperative consequences of laparoendoscopic single site surgery relative to conventional laparoscopy in presumed benign ovarian cyst.

The hypothesis is that single incision technique might offer advantages over the standard multi-port laparoscopy as potentially leading to less postoperative pain and improved cosmoses from a relatively hidden umbilical scar, as well as risk reduction of postoperative wound infection, hernia formation and elimination of multiple trocar site closure


Eligibility criteria: Inclusion Criteria:

* The patients are aged 18 to 45 years with BMI \< 35 kg/m2 and that they exhibit a surgical indication for a presumed benign ovarian pathology (PBOP) according to RCOG Guideline no. 62. 2011:

  * simple ovarian cysts \>7cm and \<15cm.
  * Persistent simple cyst for more than 3 months.
  * Symptomatic patients with complicated cyst (e.g. hemorrhagic cyst, torsion, etc)

Exclusion Criteria:

* • Previous midline laparotomies as suspected massive adhesions affecting intraoperative maneuvers and time.

  * Chronic pelvic pain, endometriosis or pelvic inflammatory diseases will be excluded to avoid pelvic adhesions and bias in the quantification of postoperative pain.
  * Do not possess a native umbilicus giving difficult access to single port.
  * The 'risk of malignancy index' (RMI) should be used to exclude those women at greater risk of malignancy. Using an RMI cut-off of 200, a sensitivity of 70% and specificity of 90% can be achieved. if features suggestive of malignancy are encountered, a gynecological oncologist should be consulted regarding further evaluation and staging.
  * Benign teratomas for the difficulty of extraction after removal that affects the intraoperative maneuvers and time.
  * Contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
  * Contraindication to general anesthesia as all laparoscopic procedures are done under GA.
  * Contraindication to non-steroidal anti-inflammatories, paracetamol, or tramadol.

Primary outcomes:
measure: Postoperative pain
timeFrame: at 24 hours ± 2 hour after the intervention
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative
measure: the need for conversion to laparotomy
timeFrame: intraoperative
measure: the need to add an additional trocar
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05208398: Apixaban in Patients With Left Ventricular Thrombus
Official title: Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Left Ventricular Thrombus
Lead sponsor: Saud Al Babtain Cardiac Center
Sponsor class: OTHER_GOV
First posted: 2022-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.
Primary purpose: TREATMENT

Brief summary: Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).


Eligibility criteria: Inclusion Criteria:

All the following criteria must be fulfilled:

* Ages between 18 and 80 years,
* History of anterior wall MI, either acute (within a week) or recent (within a month)
* Evident left ventricular thrombus (LVT) by transthoracic echocardiography,
* Naïve to oral anticoagulants (OAC)
* stable to start OAC

Exclusion Criteria:

* Other indications for OAC,
* Patients with contraindications for OAC,
* Right ventricular thrombus or atrial thrombus,
* History of confirmed stroke or other systemic embolization within the previous six months,
* High bleeding risk,
* Severe renal impairment,
* Patients with expected difficulties to follow the INR strictly.

Primary outcomes:
measure: Resolution of left ventricular thrombus
timeFrame: 3 months
Secondary outcomes:
measure: Resolution of left ventricular thrombus
timeFrame: 6 months
measure: Safety outcome
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Saud AlBabtain Cardiac Center
Study officials:
References:
Clinical trial NCT01888497: Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, CROSS-OVER, PLACEBO-CONTROLLED, SINGLE DOSE, CLINICAL TRIAL TO ASSESS THE NEXT-DAY RESIDUAL EFFECTS OF GABAPENTIN, DIPHENHYDRAMINE AND TRIAZOLAM ON SIMULATED DRIVING PERFORMANCE IN NORMAL VOLUNTEERS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Sleeplessness
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 59
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal volunteer subjects. It will also examine other measures of next-day performance and next-day sleepiness.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females of non-childbearing potential, 25-55 years of age
* Valid driver's license

Exclusion Criteria:

* Psychiatric disorder
* Recent history of clinically significant neurological disorder, such as seizures, stroke, multiple sclerosis, or head trauma
* Recent histroy or current treatment for sleep disorder

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP)
timeFrame: 7.25 hours post-dose
Secondary outcomes:
measure: Speed Deviation
timeFrame: 7.25 hours post dose
measure: Lane Exceedance
timeFrame: 7.25 hours post-dose
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Baptist Sleep Centers, LLP
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Sleep Lab
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002297: A Study of Isoprinosine in Patients With Lymph Node Disease
Official title: A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphatic Disease
HIV Infections
Keywords: Inosine Pranobex
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include:

Signs and symptoms:

* Lymphadenopathy.
* Fever.
* Weight loss.
* Occurrence of opportunistic infections.

Cell-mediated immune system parameters:

* T-helper cell (OKT4) numbers and proportions.
* T-suppressor cell (OKT8) numbers and proportions.
* Natural killer (NK) cell activity.
* Lymphocyte blastogenic response to phytohemagglutinin (PHA).
* Lymphocyte blastogenic response to pokeweed mitogen (PWM).
* Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.
* Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora.

Safety parameters:

* Blood chemistry including serum uric acid (PurposeA-12).
* Complete blood count (CBC).
* Platelet count.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.

Concurrent Medication:

Excluded:

* Systemic corticosteroids.
* Cytotoxic immunosuppressive agents.
* Radiotherapy.

Critically ill patients or those with CDC-defined AIDS are excluded.

Prior Medication:

Excluded within 1 month of study entry:

* Immunotherapy.

Patients with persistent generalized lymphadenopathy (PGL).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Newport Pharmaceuticals International Inc
state: California
Study officials:
References:
Clinical trial NCT00999297: Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate
Official title: Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate: A Double-blind Randomized Parallel Arm Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight
Keywords: thermogenesis
respiratory quotient
fat oxidation
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Ajinomoto USA, INC.
First posted: 2009-10-21
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A 4 week intake of drug to find a natural substance that may modify energy balance and may enhance health in combination with lifestyle changes with possible decrease in body weight.

Detailed description: This study is a double-blind, placebo-controlled, single center, randomized, parallel arm clinical trial to test the impact of Dihydrocapsiate (placebo, 3 and 9 mg/d) ingested for 4 weeks on resting metabolic rate and fat oxidation measured by indirect calorimetry.

Eligibility criteria: Inclusion Criteria:

* Men between 20-60 years old
* Healthy as assessed by medical history and standard medical exam
* Weight-stable
* Body mass index of 25 to 34.9 kg/m2
* Non-smoker
* Sedentary lifestyle: not being physically active grater than 3 days/week for 20 min each time for the previous 6 months, and not participating in regular resistance exercise.

Exclusion Criteria:

* Subjects enrolled in a diet to increase or decrease body weight
* Special diet or food aversiions to common foods
* Has allergy to chilli pepper
* Eating chilli peppers on a daily basis
* Usually consuming more than 2 cups of tea or coffee/day
* Usually consuming more than 4 cans of caffeinated soft drinks a day
* Usually consuming more than 3 standard alcohol drinks/day
* Regular use of medications (weight loss drugs, drugs affecting energy metabolism, drugs for depression)
* Usual intake of illicit substances
* Claustrophobia
* Participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Primary outcomes:
measure: The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Eric Ravussin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galgani JE, Ryan DH, Ravussin E. Effect of capsinoids on energy metabolism in human subjects. Br J Nutr. 2010 Jan;103(1):38-42. doi: 10.1017/S0007114509991358. Epub 2009 Aug 12.
citation: Galgani JE, Ravussin E. Effect of dihydrocapsiate on resting metabolic rate in humans. Am J Clin Nutr. 2010 Nov;92(5):1089-93. doi: 10.3945/ajcn.2010.30036. Epub 2010 Sep 8.
Clinical trial NCT05285397: Effect of Liraglutide on Weight Loss in Patients Who Have Undergone Revisional Bariatric Surgeries.
Official title: Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Keywords: Liraglutide
Morbid obesity
secondary bariatric surgery
revisional bariatric surgery
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2022-03-17
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our primary objective is to assess the effect of Liraglutide on weight loss in patients who have undergone secondary bariatric surgeries. We set out to assess if Liraglutide is a viable option to augment weight loss in said category.


Eligibility criteria: Inclusion Criteria:

* Undergone primary bariatric surgery
* Need secondary bariatric surgery due to either weight regain (regained weight to have BMI \> 35) or medical associated diseases

Exclusion Criteria:

* Prior use of GLP-1 agonist
* Past history of pancreatitis
* Personal or family history of medullary thyroid cancer
* Pregnancy or lactation
* Acute coronary syndrome
* Hepatic or renal dysfunction
* Active malignancy

Primary outcomes:
measure: Percentage Total weight loss
timeFrame: 6 months
measure: Percentage Excess body weight loss
timeFrame: 6 months
Secondary outcomes:
measure: Comorbidities
timeFrame: 6 months
measure: Weight
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: HbA1C
timeFrame: 6 months
measure: Fasting Blood Glucose (FBG)
timeFrame: 6 months
measure: HOMA-IR
timeFrame: 6 months
measure: Resolution of type 2 Diabetes Mellitus
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Lipid profile
timeFrame: 6 months
measure: Sleep apnea
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Madina Women's Hospital
Study officials:
References:
citation: Thakur U, Bhansali A, Gupta R, Rastogi A. Liraglutide Augments Weight Loss After Laparoscopic Sleeve Gastrectomy: a Randomised, Double-Blind, Placebo-Control Study. Obes Surg. 2021 Jan;31(1):84-92. doi: 10.1007/s11695-020-04850-4. Epub 2020 Jul 12.