louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03296969: Rectus Muscle Re-approximation at Cesarean Delivery
Official title: The Value of Rectus Muscle Re-approximation at Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Cesarean Section Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We include in our study 200 pregnant women, primigravidas, at term who underwent elective lower segment Cesarean section for the first time among the age group of 20 - 35 years.

The patients are divided randomly into two groups as follows:

* Group (A): undergoing rectus muscle re-approximation
* Group (B): not undergoing rectus muscle re-approximation

Detailed description: We include in our study 200 pregnant women, primigravidas, at term who underwent elective lower segment Cesarean section for the first time among the age group of 20 - 35 years.

The patients are divided randomly into two groups as follows:

* Group (A): undergoing rectus muscle re-approximation
* Group (B): not undergoing rectus muscle re-approximation
* Examination for diastasis recti abdominis is done for all included patients before delivery, at 6 weeks, and 6 months postpartum. The women are tested in a standardized supine position with arms crossed over the chest. They are instructed to perform an abdominal crunch till the shoulder blades are off the bench. Then we measure the inter-recti distance. If there is no separation or separation ˂ 2 finger breadths so, there is no diastasis recti abdominis. But if the separation is more than 2 finger breadths or more than 4.5 cm so, this is considered diastasis recti abdominis.

The same surgical techniques are used for both groups. All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide.

Eligibility criteria: Inclusion Criteria:

* primigravida
* undergoing elective Cesarean section

Exclusion Criteria:

* Patients with history of any pelvic or abdominal surgery those having any medical disorder with pregnancy patients with BMI ≥ 40 chronic analgesia use multiple pregnancies

Primary outcomes:
measure: Post-operative pain
timeFrame: 4 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05692869: A Study of Continuous Blood Pressure Monitoring in Healthy Participants
Official title: A Study to Investigate Continuous Blood Pressure Monitoring Using Traditional Device (ABPM) Versus Novel Devices (Biobeat and Aktiia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study in healthy participants is to find out whether the traditional ambulatory blood pressure monitor (ABPM) and newer wearable devices (EmbracePlus smartwatch device, Biobeat chest patch device, and Aktiia wrist device) will accurately pick up changes in blood pressure caused by 2 different medications (propranolol and pseudoephedrine). The study will last about 29 days excluding the screening period of 28 days.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females
* Have a body mass index (BMI) of 18.0 to 35 kilograms/square meter (kg/m2), inclusive at screening
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion Criteria:

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have history of sensitive skin or chronic skin conditions, like eczema
* Regular use of known drugs of abuse
* Are women who are pregnant or lactating
* Have known allergies to medications used in the study

Primary outcomes:
measure: The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device
timeFrame: Baseline through 48 hours
Secondary outcomes:
measure: The Mean Change in SBP Using Wrist Device
timeFrame: Baseline through 48 hours
measure: The Mean Change in Diastolic Blood Pressure (DBP) Using Chest Patch Device and Wrist Device
timeFrame: Baseline through 48 hours
measure: The Mean Change in SBP Using Chest Patch Device and Wrist Device
timeFrame: Baseline through 120 hours
measure: The Mean Change in DBP Using Chest Patch Device and Wrist Device
timeFrame: Baseline through 120 hours
measure: The Mean Change in SBP Using Chest Patch Device, Wrist Device and ambulatory blood pressure monitor (ABPM)
timeFrame: Baseline through 48 hours
measure: The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM
timeFrame: Baseline through 48 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01577069: Predictive Factors of the Treatment Failure in Hepatitis C Virus (HCV) Infected Patients Treated With Telaprevir
Official title: Predictive Factors of the Treatment Failure in HCV Mono-infected Patients Treated With Pegylated-interferon/Ribavirin/Telaprevir.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C
Direct Antiviral agent (DAA)
Ultra-deep pyrosequencing
Single polynucleotide polymorphisms
Treatment-resistant mutants
Hepatitis C Virus Protease Inhibitor
Lead sponsor: Association HGE CHU Bordeaux Sud
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
First posted: 2012-04-13
Enrollment: 73
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: HCV mono-infected patients treated in the Hepatology Unit of Pr Victor de Lédinghen (Hôpital du Haut-Lévêque, Pessac)

Brief summary: The purpose of the study is to

1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment.


Eligibility criteria: Inclusion Criteria:

* HCV mono-infected subjects
* Age \> 18 years

Exclusion Criteria:

* HBV co-infection

Primary outcomes:
measure: virological resitance
timeFrame: 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital du haut-Lévêque
Study officials:
affiliation: University Hospital, Bordeaux
name: Victor de lédinghen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00699569: Hyperimmune Colostrum and Oral Mucositis
Official title: The Effect of Hyperimmune Colostrum on Radiation-Induce Oral Mucositis of Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: hyperimmune colostrum
mucositis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of oral mucositis in patients with head and neck cancer undergoing high-dose radiation.


Eligibility criteria: Inclusion Criteria:

* Patients with: naso-pharynx, oral cavity, oro-pharynx and advanced localized laryngeal cancer.

Exclusion Criteria:

* Other tumors
* Non-epithelial tumors
* Pregnancy
* Poor functional status

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Nachum Vaisman, Prof'
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02455869: Comparison of Alendronate With Atorvastatin in Chronic Periodontitis
Official title: Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 104
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Detailed description: Background: Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.

Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth \[PD\], and clinical attachment level \[CAL\]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

* Patients with a known systemic disease;
* known or suspected allergy to the ALN/bisphosphonate group and ATV/statin group;
* on systemic ALN/bisphosphonate and therapy ATV/statin group;
* with aggressive periodontitis;
* who used tobacco in any form;
* alcoholics;
* immunocompromised patients;
* and pregnant or lactating females were excluded from the study

Primary outcomes:
measure: Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
timeFrame: Baseline to 6 months and Baseline to 9 months
Secondary outcomes:
measure: Plaque index
timeFrame: 3,6 and 9 months
measure: Modified sulcus bleeding index
timeFrame: 3,6 and 9 months]
measure: Probing pocket depth
timeFrame: 3,6 and 9 months]
measure: Clinical attachment level
timeFrame: 3,6 and 9 months]
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00959569: Esmolol in Cardiac Surgery
Official title: Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Keywords: esmolol
cardiac surgery
cardiac anesthesia
mortality
beta blockers
beta-blockers
cardiac protection
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 200
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 large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.


Eligibility criteria: Inclusion Criteria:

* end diastolic diameter \>60 mm and/or an ejection fraction \<50%
* written informed consent
* age \>18 years

Exclusion Criteria:

* previous unusual response to esmolol
* inclusion in other randomized studies
* esmolol administration in the previous 30 days
* emergency operation

Primary outcomes:
measure: Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.
timeFrame: Hospital stay (approximately 2 weeks)
Secondary outcomes:
measure: Number of patients with ventricular fibrillation after cardiopulmonary bypass
timeFrame: 30 days and 1 year
measure: Number of patients with low cardiac output syndrome
timeFrame: 30 days and 1 year
measure: Number of patients requiring post-operative inotropic support
timeFrame: 30 days and 1 year
measure: peak postoperative cardiac troponin level
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Vita-Salute University
Study officials:
References:
citation: Zangrillo A, Turi S, Crescenzi G, Oriani A, Distaso F, Monaco F, Bignami E, Landoni G. Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):625-32. doi: 10.1053/j.jvca.2009.01.003. Epub 2009 Mar 18.
citation: Crescenzi G, Rosica C, Marino G, Serini SM, Covello RD, Landoni G, Zangrillo A. The use of esmolol to treat systolic anterior motion of the mitral valve after mitral valve repair. Eur J Anaesthesiol. 2008 Apr;25(4):342-3. doi: 10.1017/S0265021507002876. No abstract available.
citation: Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.
citation: Crescenzi G, Landoni G, Zangrillo A, Guarracino F, Rosica C, La Canna G, Alfieri O. Management and decision-making strategy for systolic anterior motion after mitral valve repair. J Thorac Cardiovasc Surg. 2009 Feb;137(2):320-5. doi: 10.1016/j.jtcvs.2008.08.018.
Clinical trial NCT05578469: Surgical Treatment of Marfan Syndrome With Subluxation Lens
Official title: Effect of Different Surgical Treatment of Marfan Syndrome With Subluxation Lens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Marfan Syndrome
Lens Subluxation or Dislocation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lens dislocation of Marfan syndrome who accepted different surgical treatments

Brief summary: To analyze the postoperative visual effects, and to compare the safety and efficacy of different surgical treatment with of Marfan Syndrome with subluxation lens.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with MFS according to the revised Ghent etiology.
2. refractive errors difficult to correct.
3. pupillary block glaucoma caused by severe dislocation of the lens

Exclusion Criteria:

Keratoconus, late glaucoma, uveitis, history of traumatic lens dislocation, and preoperative retinal rupture with or without retinal detachment (RD)

Primary outcomes:
measure: Uncorrected distance visual acuity
timeFrame: 1 month postoperatively
measure: Uncorrected distance visual acuity
timeFrame: 3 month postoperatively
measure: Corrected distance visual acuity
timeFrame: 1 month postoperatively
measure: Corrected distance visual acuity
timeFrame: 3 month postoperatively
measure: intraocular pressure
timeFrame: 1 month postoperatively
measure: intraocular pressure
timeFrame: 3 month postoperatively
measure: postoperative complication
timeFrame: Early and late stages
Secondary outcomes:
measure: Postoperative astigmatism and astigmatism axial of cornea
timeFrame: 1 month postoperatively
measure: Postoperative astigmatism and astigmatism axial of cornea
timeFrame: 3 month postoperatively
measure: endothelial cell count
timeFrame: 1 month postoperatively
measure: endothelial cell count
timeFrame: 3 month postoperatively
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
Study officials:
References:
Clinical trial NCT02757469: Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure
Official title: Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Ovarian Insufficiency
Menopause, Premature
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Premature ovarian insufficiency (POI) is a life-changing condition that affects women in their reproductive age. There is a lack of reports which focus on how to improve the reproductive outcome of these women who wish to conceive spontaneously or use assisted conception with their own oocytes. However, one could surmise that it is important to lower gonadotropin levels into the physiological range before embarking on any treatment, even if natural conception is the only choice for the woman/couple.


Eligibility criteria: Inclusion Criteria:

* premature ovarian failure
* normal anatomy
* normal secondary sexual characteristics
* essential or idiopathic

Exclusion Criteria:

* chromosomal disorder
* iatrogenic injury
* autoimmune diseases
* infection
* genetic diseases

Primary outcomes:
measure: live birth
timeFrame: 3 years
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 3 years
measure: multiple pregnancy
timeFrame: 3 years
measure: miscarriage
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Wei Shang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alper MM, Jolly EE, Garner PR. Pregnancies after premature ovarian failure. Obstet Gynecol. 1986 Mar;67(3 Suppl):59S-62S. doi: 10.1097/00006250-198603001-00018.
citation: Ben-Nagi J, Panay N. Premature ovarian insufficiency: how to improve reproductive outcome? Climacteric. 2014 Jun;17(3):242-6. doi: 10.3109/13697137.2013.860115. Epub 2013 Dec 16.
Clinical trial NCT05439369: Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease
Official title: Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Valvular Heart Disease Stenosis and Regurgitation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: the study will include consecutive eligible patients recruited in assiut university hospital

Brief summary: NPs can be used To detect subset of asymptomatic with subtle LV dysfunction for further evaluation and earlier referral for intervention and its correlation with echocardiographic finding.

Detailed description: Each patient included in the study will undergo:

1. History taking:

   Analysis of patient symptoms and signs (dyspnea , orthopnea , Paroxysmal nocturnal dyspnea, lower limb edema , tachypalpitations,...etc )
2. Clinical examination:

   * Detecion of each patient body weight , height , calculation of BMI.
   * General examination for detection of signs of Heart failure (raised JVP , lower limb edema, ..etc)
   * Examination to respiratory system
   * Auscultation of the heart for detection of valvular affection before echocardiography

Invesigations:

Laboratory investigations:

Urea and creatinine . b) ECG : for exclusion of atrial fibrillation and other arrythmias. 2D Transthorathic Echocardiography (TTE) Evaluation of valve morphology and thickness , gradients and valve area , regurgitant lesions and its severity.

Evaluation of internal cardiac dimensions and function. 5- Natriuretic peptides: as a useful screening tool to differentiate symptomatic and asymptomatic patients.

Eligibility criteria: Inclusion Criteria:

* All patients echocardiographically diagnosed with significant valve lesions. Rheumatic Heart disease with significant but asymptomatic valvular Heart Disease especially (Mitral valve disease )(MS and MR) Gender: male \& female

Exclusion Criteria:

* Cases with increased level of BNP as in :

Renal impairment Advanced age and obesity Atrial fibrillation and acute coronary syndromes Prior lung diseases and acute illness

Primary outcomes:
measure: early detection of subclinical LV dysfunction.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University ,faculty of medicine
Study officials:
affiliation: Assiut University
name: Mohamed Aly Abdelhafez, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: