louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02368613: A Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-23
Enrollment: 64
Sex: ALL
Minimum age (years): 19
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 evaluate adequate-dose of DW-3102 in the treatment of hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each groups are composed by 16, will be participated in this trial.


Eligibility criteria: Inclusion Criteria:

* More than 19 years old
* Those who meet the fasting serum lipid levels along table
* Those who are under 350 mg/dL of TG level when fasting

Exclusion Criteria:

* The patient of acute arterial disease
* The patient of severe heart failure(NYHA class III or IV)
* Within the last 6 months clinically meaningful treatment that requires that arrhythmias or cardiac conduction disorders
* Uncontrolled hypertension ( systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg or more later)
* Endocrine or metabolic disease patients known to affect serum lipids or lipoproteins
* Fibromyalgia, myopathy, rhabdomyolysis, or sudden muscle pain or have in the past, such as statin (HMG CoA reductase inhibitors) in patients with muscle -related adverse drug experience of the system
* Drug malabsorption by gastrointestinal surgery experience (but simple appendectomy and hernia surgery is excluded) or gastrointestinal disorders ( Crohn's disease , ulcers , acute or chronic pancreatitis , etc. )
* Patients with history of malignancies including leukemia and lymphoma within the past five years
* If severe renal impairment or in patients with impaired liver and hematological findings following the same
* Patients who have participated in another clinical trial within the previous 30 days or Prior to the administration of at least five times the half-life of the active ingredient is not elapsed patient IND
* Those having a known hypersensitivity to hyperlipidemia treatment
* Patients with hypersensitivity or allergy to cruciferous plants
* Patients with a history of drug or alcohol abuse within the last 12 months
* Female patients of childbearing age
* In the case of male test subjects , if the spouse does not agree with the use of childbearing age when women work , recognized contraception exclusion criteria presented in Section 15
* Patient who are inappropriate by investigator's decision

Primary outcomes:
measure: The change of LDL-C%
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02746913: Ambulatory Pessary Trial
Official title: Ambulatory Pessary Trial as a Preoperative Method for Diagnosing Occult Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: Pelvic, Urodynamic, Vaginal Wall
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two methods for assessing patients with pelvic organ prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely accepted and well-studied method for diagnosing occult stress urinary incontinence preoperatively, but an ambulatory pessary trial is a less expensive option that is available to a wider group of practitioners and evaluates patient while they are engaged in their daily activities.


Eligibility criteria: Inclusion Criteria:

* Female
* Patients planning to undergo pelvic organ prolapse surgery and preoperative urodynamic testing within 6 months of recruitment.
* Stage 2 or greater pelvic organ prolapse on pre op POP-Q exam
* Negative stress test on clinical exam
* Cognitive capacity to complete questionnaires and voiding diary

Exclusion Criteria:

* Stress incontinence during provocative stress test on pre-operative exam.
* Occult stress urinary incontinence demonstrated on pre-operative physical exam
* Known ability to retain a pessary for the 3 day trial
* \< age 18
* History of bladder augmentation or artificial sphincter
* Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.)
* Non ambulatory patients
* Active infections of the vagina or pelvis (Pelvic inflammatory disease, infectious vaginitis, etc.)
* Occult stress urinary incontinence demonstrated on pre-operative physical exam
* Known ability to retain a pessary for the 3 day trial
* \< age 18
* History of bladder augmentation or artificial sphincter
* Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.)
* Non ambulatory patients
* Active infr

Primary outcomes:
measure: Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire
timeFrame: 3 Days
measure: Overactive bladder quality of life (QAB-Q)- short term questionnaire
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Benjamin Brucker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03566836: Atrial Fibrillation Detection Using Garmin Wearable Technology
Official title: Atrial Fibrillation Detection Using Garmin Wearable Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Smart Watch
Garmin
Wearable
Cardioversion
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Garmin International
First posted: 2018-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are receiving care from the University of Kansas Health System.

Brief summary: The purpose of this study is to evaluate the feasibility of detecting atrial fibrillation (AF) in patients with AF using a wearable wrist device/smart watch.

Detailed description: Even though AF is common and associated with increased risk of stroke, quite often it goes undetected until late in the course of the condition. If AF can be detected with simpler tools like a smart watch, it would enable providers to identify patients with AF much earlier in the course of the condition (even before being seen by a physician) and hopefully be able to prevent stroke. This study is being done to identify a technology that can likely identify AF using a smart watch.

Eligibility criteria: Inclusion Criteria:

* All patients with AF scheduled to undergo electrical cardioversion at the University of Kansas Health System

Exclusion Criteria:

* Patients with no detectable PPG
* Hemodynamically unstable patients
* Patients who cannot give informed consent
* Patients with tattoos on the wrists

Primary outcomes:
measure: Sensitivity and specificity of Garmin wearable device in detecting AF
timeFrame: Visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Yeruva Madhu Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03139136: Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
Official title: A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Modern Biosciences Ltd
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 121
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: Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage.The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate.

Detailed description: Rheumatoid Arthritis is a chronic autoimmune disease characterised by synovial inflammation and cartilage and bone degradation, leading to joint destruction and progressive disability.

The aim of the study is to evaluate the safety and tolerability of MBS2320 in patients with RA following chronic administration. In addition, the study aims to evaluate the effects of MBS2320 on measures of disease activity.

Eligibility criteria: Inclusion Criteria:

* Male or female patients of childbearing or non-childbearing potential with with active RA, receiving stable once-weekly methotrexate
* between 18 and 75 years of age, inclusive.

Exclusion Criteria:

* Patients who are currently pregnant or breastfeeding.
* Patients who are being treated with biological or non-biological disease-modifying anti-rheumatic drug therapy.
* Patients with a history of any other inflammatory or arthritic disease in addition to RA that may interfere with the study.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (safety and tolerability)
timeFrame: 12 weeks
Secondary outcomes:
measure: Disease Activity Score 28 (DAS28)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Arensia
city: Chisinau
country: Moldova, Republic of
facility: Arensia
city: Bucharest
country: Romania
facility: Arensia
Study officials:
affiliation: Arensia Exploratory Medicine
name: Inga Bodrug, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03002636: Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under Different Anesthesia Ways
Official title: Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under General Anesthesia or Intraspinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Obesity
Anesthesia Complications
Body Mass Index (BMI)
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: International Peace Maternity and Child Health Hospital
First posted: 2016-12-26
Enrollment: 900
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) \>40 kg/m2 , severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with BMI\<30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women met inclusion criteria and 900 women received allocated intervention. All patients were divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and non-Obesity group(n=300) according to body mass index (BMI) \>40 kg/m2, 30 kg/m2≤BMI ≤40 kg/m2 and BMI\<30 kg/m2.900 patients completed the protocol and related data were analysed.

Detailed description: 900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were divided into 3 groups

Eligibility criteria: Inclusion Criteria:

* patients with ASA Physical Status gradeΙΙ～ΙΙΙ.

Exclusion Criteria:

* scoliosis, congenital heart disease, lung, liver, kidney diseases or increased intracranial pressure (ICP)

Primary outcomes:
measure: Patients numbers of obese parturient complications
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Yongtao Gao, MD
role: STUDY_DIRECTOR
References:
citation: An X, Zhao Y, Zhang Y, Yang Q, Wang Y, Cheng W, Yang Z. Risk assessment of morbidly obese parturient in cesarean section delivery: A prospective, cohort, single-center study. Medicine (Baltimore). 2017 Oct;96(42):e8265. doi: 10.1097/MD.0000000000008265.
Clinical trial NCT00812136: Parent Mentor Asthma Study
Official title: Using Parent Mentors to Improve Asthma Care for Urban Minority Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Using Parent Mentors to Improve Asthma Care for Urban Minority Children
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2008-12-22
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: Asthma disproportionately affects minorities, but few studies have evaluated interventions to improve asthma outcomes in minority children.The purpose of the study is to determine whether Parent Mentors (PMs) are more effective than traditional asthma care in reducing minority children's asthma morbidity, costs, and use of services, while increasing families' quality of life and parental self-efficacy.


Eligibility criteria: Inclusion Criteria:

* The child was 2-18 years old
* African-American or Latino race/ethnicity for the child (by parental identification)
* Primary residence in a Milwaukee zip code
* ED or inpatient ward admission with a primary diagnosis of asthma.

Exclusion Criteria:

* Significant co-morbidity, including other pulmonary conditions, cardiac pathology, renal abnormalities, diabetes mellitus, epilepsy, and other co-morbidities that might lead to ED visits or hospitalizations, and current enrollment in a case management, intervention, or outreach program for childhood asthma management.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UT Southwestern Medical Center
name: Rebecca Gruchalla, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flores G, Bridon C, Torres S, Perez R, Walter T, Brotanek J, Lin H, Tomany-Korman S. Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors. Pediatrics. 2009 Dec;124(6):1522-32. doi: 10.1542/peds.2009-0230.
Clinical trial NCT05919836: Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics
Official title: Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Inguinal Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 69
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison between multiple approaches of laparoscopic hernia ( percutaneous assisted laparoscopic hernia, purse string closure of hernial sac, total dissection of hernial sac).

Detailed description: In pediatric age, indirect inguinal hernia represents more than 95% of the hernial disease. It is a congenital type, in contrast with adulthood in which acquired forms are more frequently found.

Inguinal hernia repair is one of the most frequently performed surgical procedure in infants and young children. Laparoscopic hernia repair in infancy and childhood is still debatable. There are many techniques available for laparoscopic hernia repair in pediatrics.

Laparoscopic hernial repair is increasingly adopted even for neonates and has achieved a high success rate with low recurrence rate with long-term follow-up. The main advantages of laparoscopy are no incision of the fascia, exploration of the other side in case of bilateral hernia, and visualization and safeguarding of the vas deferens and the spermatic vessels. Moreover, it is advantageous over open technique in case of recurrent hernia. Different modalities of techniques have been used for repair such as needlescopic disconnection of hernia sac, flip flap technique, muscular arch repair, and ring closure.

Eligibility criteria: Inclusion Criteria:

* patients in the age limit with congenital inguinal hernia

Exclusion Criteria:

* recurrent hernias
* cases inwhich laparoscopic surgery is contraindicated
* cases with collagen defect diseases

Primary outcomes:
measure: Operative time
timeFrame: 4 months
measure: Early recurrence
timeFrame: 4 months
measure: Post operative pain duration
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02681536: Miniflare Versus Long Protocol in Poor Responders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study is performed to compare the outcomes of two stimulation protocols, the minidose long protocol versus the microdose flare protocol in poor responders undergoing IVF/ICSI.


Eligibility criteria: Inclusion Criteria:

* poor responder women who fulfilled the criteria defined by the ESHRE consensus in 2011\[4\]; Poor responder females are those who possess two out of these three criteria: i) Female age ≥40 years; ii) Females who have at least one previous cancelled IVF cycle; iii) POR according to AFC ≤5 or low AMH value.

Exclusion Criteria:

* females with FSH more than 20 IU/L
* females with previous ovarian surgery
* females suffering from causes of infertility other than poor ovarian response, cases with polycystic ovaries syndrome
* females refusing to be enrolled in the study, females with any endocrine disorder such as: diabetes, thyroid
* patients with male factor of infertility.

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina MR Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04981236: Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty
Official title: Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Postoperative Pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 66
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: Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block provides sufficient analgesia but it is still the potential for quadriceps weakness that might delay ambulation. Periarticular injection has attached attention as an effective analgesic modality with a low prevalence of adverse effects. The investigators will compare ultrasound-guided PENG block with periarticular injection in patients undergoing total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Aged 19 years old or older
2. American Society of Anesthesiologists Physical Status 1-3
3. Scheduled for elective unilateral total hip arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study
2. Hepatic or renal insufficiency
3. Opioid dependency
4. Coagulopathy
5. Pre-existing neurologic or anatomic deficits in the lower extremities
6. Severe psychiatric illness

Primary outcomes:
measure: Numeric rating scale pain score
timeFrame: at 24 hours postoperatively
Secondary outcomes:
measure: Numeric rating scale pain score
timeFrame: at 6 hours postoperatively and 48h postoperatively
measure: Quadriceps muscle strength
timeFrame: at 24 hours postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
name: Yong Seon Choi
role: PRINCIPAL_INVESTIGATOR
References: