louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02962011: Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
Official title: Randomized Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cesarean Section
Keywords: Cesarean, incision, suture,
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2016-11-11
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Knotless barbed suture vs conventional suture of uterine incision
Primary purpose: TREATMENT

Brief summary: This was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Also measured were blood loss during incision closure and the use of additional hemostatic sutures. Informed consent was obtained


Eligibility criteria: Inclusion Criteria:

* elective cesarean
* elective repeat cesarean

Exclusion Criteria:

* emergent or urgent cesarean
* PROM
* chorioamninitis
* placental abruption
* placenta previa or accreta
* known uterine fibroids
* women with known medical problems such as coagulopathy

Primary outcomes:
measure: Uterine incision closure time
timeFrame: 5 months
Secondary outcomes:
measure: uterine incision blood loss
timeFrame: 5 months
measure: hemostatic suture use
timeFrame: 5 months
Other outcomes:
Locations:
city: Zefat
country: Israel
facility: Ziv Medical Center
Study officials:
affiliation: Ziv Medical Center
name: David Peleg
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peleg D, Ahmad RS, Warsof SL, Marcus-Braun N, Sciaky-Tamir Y, Ben Shachar I. A randomized clinical trial of knotless barbed suture vs conventional suture for closure of the uterine incision at cesarean delivery. Am J Obstet Gynecol. 2018 Mar;218(3):343.e1-343.e7. doi: 10.1016/j.ajog.2018.01.043. Epub 2018 Feb 5.
Clinical trial NCT00134511: Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder
Official title: Phase 3 Multi-Center, Open Label, Forced Titration Study To Evaluate The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Combination Administered Orally, Once Daily (Qd) In Patients With Homozygous Familial Hypercholesterolaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia, Familial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol

Detailed description: For additional information please call: 1-800-718-1021

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Homozygous Familial Hypercholesterolemia

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study

Primary outcomes:
measure: Change in LDL-C and HDL-C
Secondary outcomes:
measure: Other lipid variables
Other outcomes:
Locations:
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
state: Johannesburg
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04840511: The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping
Official title: The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping in the Patients Undergoing the Robot-assisted Prostatectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urologic Cancer
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be done to investigate perioperative lidocaine infusion on neutrophil extracellular trapping in the patients undergoing the robot-assisted prostatectomy.

Detailed description: Neutrophil extracellular trapping by analyzing the meyloperoxidase, neutrophil elastase, citrullinated histone3

Eligibility criteria: Inclusion Criteria:

* patients scheduled robot-assisted prostatectomy

Exclusion Criteria:

* lidocaine allergy Hx
* hemodynamic unstable patients
* weight \< 40kg
* arrhythmia or bradycardia

Primary outcomes:
measure: Concentration of citrullinated histone3
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Concentration of meyloperoxidase
timeFrame: 24 hours after surgery
measure: Concentration of neutrophil elastase
timeFrame: 24 hours after surgery
Other outcomes:
measure: the severity of postoperative pain using NRS
timeFrame: during postoperative 24 hours
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Young Eun Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03943511: Discharged with Indwelling Chest Tube and Valve
Official title: A Randomized Study Evaluating Patients Discharged with Indwelling Chest Tube and Valve
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Prolonged Air Leak
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.

Detailed description: This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be screened prior to discharging from the hospital and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained the subject will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped. The subject will be followed until they have their chest tube removed.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Male and Female
* Consultation with a thoracic surgeon
* Discharge from the hospital with a chest tube and valve in place
* Subject is able to understand the study procedures and provide informed consent.

Exclusion Criteria:

* Pregnancy
* Allergy to Keflex and Clindamycin
* Special consideration should be taken in enrolling subjects with preexisting conditions that can be exacerbated by antibiotic use but are allowed at the discretion of the treating physician.

Primary outcomes:
measure: Change in empyema in patient's discharging with an indwelling chest tube and valve.
timeFrame: 30 days post discharge
Secondary outcomes:
measure: Change of 30-day readmission in patient's discharging with an indwelling chest tube and valve.
timeFrame: 30 days post discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: K. Robert Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01158911: Uric Acid and Long-term Outcomes in Chronic Kidney Disease
Official title: Does Uric Acid Promote Progression of Kidney Disease and Development of Cardiovascular Disease in Patients With Chronic Kidney Disease?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: kidney disease
uric acid
outcomes
cardiovascular
mortality
kidney failure
Uric Acid levels in patients with Chronic Kidney Disease
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2010-07-08
Enrollment: 838
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 838 participants of the randomized arm of the Modification of Diet in Renal Disaese (MDRD) Study conducted between 1989-1993

Brief summary: Patients in the earlier stages of Chronic kidney disease (CKD) are at risk both for the development of end-stage renal disease (ESRD) (define by the requirement for dialysis or kidney transplantation) and development of cardiovascular disease (CVD). Although controversial, there is literature to suggest that uric acid may play a role in the progression of kidney disease and development of cardiovascular disease (CVD). The Modification of Diet in Renal Disease (MDRD) Study was a randomized controlled trial in patients with CKD, which examined the effects of dietary protein restriction and strict blood pressure control on progression of non-diabetic CKD. Extensive data on risk factors for progression of kidney disease and development of CVD are available, as is long term follow up. 838 of the 840 patients who were randomized have uric acid levels measured at baseline. The aims of the present study are to examine the determinants of uric acid in cross sectional analysis at baseline, to determine the association between uric acid and development of ESRD, and the association of uric acid with all-cause and CVD mortality.

Level of kidney function will be a major determinant of uric acid levels independent of other risk factors.

Level of uric acid will be associated with development of ESRD independent of level of kidney function and other risk factors.

Uric Acid levels will be associated with both all-cause and CVD mortality independent of kidney function and other risk factors.


Eligibility criteria: Inclusion Criteria:

* between 18 and 70 years of age
* with serum creatinine of 1.2 to 7 mg/dl in women and 1.4 to 7 mg/dl in men

Exclusion Criteria:

* pregnancy
* Type I diabetes
* insulin dependent type II diabetes
* renal artery stenosis
* proteinuria greater than 10mg/day
* mean arterial pressure greater than 125 mmHg
* prior kidney transplant

Primary outcomes:
measure: Kidney Failure
Secondary outcomes:
measure: CVD and All-Cause Mortality
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT03873311: Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy
Official title: The Efficacy and Safety of Azacytidine Combined With HAG Regimen Versus Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia
Keywords: Azacytidine; HAG regimen
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 114
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to explore the efficacy and safety of azacytidine and HAG regimen versus azacytidine for elderly patients with Newly Diagnosed MDS/AML/CMML in China. This is a post-marketing, interventional, multi-center, double-arm, prospective, open-label, randomized controlled study in elderly patients with MDS/AML/CMML in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given azacytidine + HAG regimen or azacytidine under the conditions of informed consent and frequent monitoring according to the clinical guideline.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 60;
* Patients with newly diagnoised diseases including MDS/AML/CMML;
* The ECOG behavior status score is less than 3 points;
* Agree to sign informed consent

Exclusion Criteria:

* Patients with a history of sever heart disease;
* Patients with severe organ dysfunction;
* Patients with other malignancies
* Patients who are allergic to the treatment of drug ingredients

Primary outcomes:
measure: Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT01093911: Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Diseases
Autoimmune Diseases
Lupus Erythematosus, Systemic
Skin and Connective Tissue Diseases
Connective Tissue Disease
Keywords: Lupus
SLE
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers and subjects with SLE

Exclusion Criteria:

* Severe neuropsychiatric or severe renal SLE
* History of chronic, recurrent, or recent severe infection
* Significant hematologic abnormalities
* History of cancer, heart failure, renal disease, liver disease or other serious illness

Primary outcomes:
measure: Assessment of safety of CDP7657 as per Adverse Event (AE) reporting
timeFrame: Day 0 to 119
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Day 0 to 119
measure: Time corresponding to Cmax (Tmax)
timeFrame: Day 0 to 119
measure: Terminal elimination half-life (t 1/2)
timeFrame: Day 0 to 119
measure: Plasma levels of anti-CDP7657 antibodies
timeFrame: Day 0 to 119
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: 6
city: Sofia
country: Bulgaria
facility: 9
city: Berlin
country: Germany
facility: 1
city: Erlangen
country: Germany
facility: 2
city: Frankfurt
country: Germany
facility: 3
city: Hannover
country: Germany
facility: 4
city: Kiel
country: Germany
facility: 8
city: Münster
country: Germany
facility: 7
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Tocoian A, Buchan P, Kirby H, Soranson J, Zamacona M, Walley R, Mitchell N, Esfandiari E, Wagner F, Oliver R. First-in-human trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus erythematosus. Lupus. 2015 Sep;24(10):1045-56. doi: 10.1177/0961203315574558. Epub 2015 Mar 16.
Clinical trial NCT02222311: Influence of Vitamin D Deficiency on the Development of Autism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-08-21
Enrollment: 300
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: Children with autism who have presented to the Child Development Institute at the Hillel Yaffe Medical Center and from pediatric neurology community clinics. The control groups include healthy age-matched children and children with Attention Deficit Disorder (ADD) who have presented to the Child Development Institute at the Hillel Yaffe Medical Center and from pediatric neurology community clinics.

Brief summary: The investigators wish to study the effect of Vitamin D on the development of autism in children. The investigators will also investigate the environmental and genetic influences on the level of Vitamin D in children with autism.


Eligibility criteria: Inclusion Criteria:

* Autistic children
* Healthy children
* Children with ADD

Exclusion Criteria:

* All others

Primary outcomes:
measure: Level of Vitamin D
timeFrame: One day
Secondary outcomes:
measure: Effect of environment on Vitamin D level
timeFrame: One week
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05354011: Effects of Kinesiotaping With and Without Active Release Technique in Patients With Carpal Tunnel Syndrome
Official title: Effects of Kinesiotaping With and Without Active Release Technique on Pain, Grip Strength, Functional Disability and Range of Motion in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: CTS
Wrist pain
Disability
Kinesiotaping
Active Release Technique
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the effects of Kinesiotaping and Active Release Technique in patients with CTS to see which method is better for improving Pain, Grip Strength, Range of Motion and functional disability.

Detailed description: Carpal tunnel syndrome (CTS) is a common nerve entrapment condition that causes pain, numbness, tingling and weakness in the hand and wrist. People suffering from CTS complain of pain, decreased ROM, loss of grip strength and in severe cases, disability. This happens when there is an increased pressure within the wrist on a nerve called "Median Nerve". This nerve provides sensations to the thumb, index, middle and half of the ring finger. People who are most susceptible to CTS are computer/keyboard workers. High force, extreme wrist motions, vibrations are causes. Other factors like genetics and pregnancy can also cause CTS. There are a lot of treatment options for CTS such as use of orthotics, steroidal injections, surgery and physical therapy. The aim of this study will be to determine the effects of kinesiotaping with and without active release technique on pain, grip strength, functional disability and range of motion in patients with carpal tunnel syndrome.

Eligibility criteria: Inclusion Criteria:

* Patients having symptoms for less than 1 year.

  * Age above 18 years.
  * Patients having positive Tinel and Phalen test.
  * Pain in the median nerve distribution with minimum score of 3 on NPRS. Ability to read and understand the study instructions and written consent form

Exclusion Criteria:

* Having any secondary entrapment neuropathy like diabetes, inflammatory arthritis, and hypothyroidism.

  * Pregnancy Skin infection on the forearm, cervical radiculopathy or polyneuropathy.
  * Previous history of Carpal Tunnel Decompression Surgery.
  * Corticosteroid injection into the Carpal Tunnel.

Primary outcomes:
measure: NPRS
timeFrame: 3 months
measure: hand dynamometer
timeFrame: 3 months
measure: Boston CTS Questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ittefaq Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Nosheen Manzoor, MS
role: PRINCIPAL_INVESTIGATOR
References: