louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03736187: Antibiotics for Prevention of SSI in Obese Women Undergoing CS
Official title: Combination Vs Single Antibiotics for Prevention of SSI in Obese Women Undergoing CS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 280
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 Groups of obese women under elective cesarean section
Primary purpose: PREVENTION

Brief summary: Effect of cephalexin plus metronidazole on SSI better than cephalexin alone in obese women undergoing CS

Detailed description: Comparison between efficacy of cephalexin alone and cephalexin plus metronidazole on surgical site infection in obese women undergoing CS and follow up of any signs of wound infection

Eligibility criteria: Inclusion Criteria:

* obese women under elective CS

Exclusion Criteria:

* immunodeficient women

Primary outcomes:
measure: Wound infection
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06116487: MRI as Alternative to CBCT for the Assessment of Furcation Involvement in Molars
Official title: Evaluation of Magnetic Resonance Imaging as Alternative to Cone Beam Computed Tomography for the Assessment of Furcation Involvement in Molars
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Periodontitis
Periodontal Diseases
Furcation Defects
Keywords: CBCT
MRI
Furcation involvement
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical detected furcation involvement at the first or second molars

Brief summary: Aim of this prospective study is to compare magnetic resonance imaging (MRI) and cone beam computed tomography (CBCT) to diagnose furcation involvement (FI) in molars in patients with periodontitis. The focus is on the differentiation of grad II and III according to Hamp et al. 1975. 140 molars (70 upper and 70 lower) will be investigated with CBCT and MRI. Due to the absence of ionic radiation MRI might be a radiation free diagnostic tool to assess FI in the future without harmful radiation for the patient. Patients of the Dental Clinic, Medical University of Vienna, who need a CBCT and have a clinically diagnosed FI can be a participant of this clinical trial and do in addition to their CBCT a MRI. The accuracy of MRI will be compared to the diagnostic gold standard CBCT. If patients need additional periodontal treatment, e.g., periodontal surgery, a subgroup will also be analysed with intraoperative measurements.


Eligibility criteria: Inclusion Criteria:

* Patients with FI grade II or III, patients who need a CBCT, not pregnant

Exclusion Criteria:

* Patients with contraindications to perform a MRI

Primary outcomes:
measure: horizontal furcation defects according to Hamp 1975
timeFrame: day 1
Secondary outcomes:
measure: horizontal bone loss
timeFrame: day 1
measure: vertical bone loss
timeFrame: day 1
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Clinic of Dentistry
Study officials:
References:
Clinical trial NCT01446887: Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
Official title: Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Deep Vein Thrombosis
Keywords: Deep Vein Thrombosis
total hip arthroplasty
prophylactic anticoagulation
randomized study
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2011-10-05
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A randomized double-blind study was conducted to determine whether prophylactic anticoagulation was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator also used logistic regression analysis with variable selection for obtaining the prediction model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical compression, duration of surgery). THA with short duration of surgery did not require prophylactic anticoagulation.


Eligibility criteria: Inclusion Criteria:

* Primary total hip arthroplasty

Exclusion Criteria:

* Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded.
* Coagulation related disease and cancer were excluded either.

Primary outcomes:
measure: all cause DVT
timeFrame: 7 days
Secondary outcomes:
measure: Major DVT
timeFrame: 7 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Center of Diagnosis and Treatment for Joint Disease, Drum Tower Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT02809287: A Novel Laparoscopic Hepatectomy Posture, Left Lateral Position Plus Jackknife Position
Official title: A Novel Laparoscopic Hepatectomy Posture, Left Lateral Position Plus Jackknife
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were diagnosed with hepatocellular carcinoma (HCC) based on the criteria established by the European Association for the Study of the Liver

Brief summary: Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H. Reith in 1991, the laparoscope has been widely used in liver disease. Based on its advantages in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been well recognized globally. Generally speaking, for lesions located in the left, front or lower part of the liver, corresponding to Couinaud segments II, III, IVb, V and VI, an LH surgery is recommended; however, for lesions located in segments VII and VIII, the surgery is high technically difficult due to poor exposure. Therefore,the investigators employ the left lateral position plus jackknife position to better expose lesions in these segments, hoping to reduce surgical time and bleeding in LH.


Eligibility criteria: Inclusion Criteria:

1. Patients were diagnosed with hepatocellular carcinoma (HCC) based on the criteria established by the European Association for the Study of the Liver
2. Tumor located in segment VI, VII, or VIII.

Exclusion Criteria:

1. Major vessel or bile duct tumor invasion,
2. Recurrent HCC
3. Tumor close to secondary vessels and bile ducts
4. Patients with extrahepatic metastasis
5. Grade C liver function,
6. Significant surgical contraindications

Primary outcomes:
measure: Operation time
timeFrame: intraoperative
measure: Blood loss
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chen JC, Zhang RX, Chen MS, Xu L, Chen JB, Yang KL, Zhang YJ, Zhou ZG. Left jackknife position: a novel position for laparoscopic hepatectomy. Chin J Cancer. 2017 Mar 20;36(1):31. doi: 10.1186/s40880-017-0190-y.
Clinical trial NCT00661687: Comparative Performance of PureVision Lens Designs
Official title: A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 206
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: The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis


Eligibility criteria: Inclusion Criteria:

* subject is myopic
* VA correctable to 0.3 logMAR or better (driving vision)
* Clear central cornea

Exclusion Criteria:

* Systemic disease affecting ocular health
* using systemic or topical medications
* wear monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings

Primary outcomes:
measure: Subjective Responses to Symptoms/Complaints
timeFrame: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits
Secondary outcomes:
measure: LogMAR Visual Acuity
timeFrame: Mean over all visits - 1 day, 1 week, 1 month
measure: Lens Characteristics
timeFrame: Over all scheduled visits day 1 - 1 month
Other outcomes:
Locations:
city: Johor Bahru
country: Malaysia
facility: Laser Focus Sdn Bhd, Vision Correction Centre
city: Makati City
country: Philippines
facility: Asian Eye Institute
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Gerard Cairns, MCOptom, PhD
role: STUDY_DIRECTOR
affiliation: Laser Focus Sdn Bhd, Vision Correction Centre
name: Benny Chian, MCOptom
role: PRINCIPAL_INVESTIGATOR
affiliation: Asian Eye Institute
name: Harvey Siy Uy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00179387: Mind-Body Program for Cancer Patients
Official title: Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Keywords: Neoplasms
Needs Assessment
Adaptation Psychological
Minority Groups
Psychotherapy, Group
Program Evaluation
Spirituality
Spiritual Therapies
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2005-09-16
Enrollment: 166
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: The purpose of this study is to find out if Mind-Body groups can help improve the physical and emotional well-being of people facing cancer or its treatment.

Detailed description: Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, relationship strains, existential distress and role losses are all potential "side-effects" of living with cancer and its treatment. Behavioral interventions have shown some success in mitigating distress and QOL impairment among cancer patients. The purpose of this randomized-controlled study is to compare the effects of Mind-body group interventions on the quality of life of patients with advanced cancer. Patients are randomized to one of two psychotherapy groups, which occur weekly for eight weeks. Quality of life assessments are conducted at baseline and two and four-month intervals.

Eligibility criteria: Inclusion Criteria:

* On Active Treatment for:

Breast Cancer Stage IV, Colorectal Cancer Stage IV, Lung Cancer Stages III \& IV, or All Other Cancers (ANY stage on treatment)

* Language is English or Spanish

Exclusion Criteria:

* Patient is currently attending other support/psychotherapy group
* Significant Cognitive Impairment
* ECOG performance status = 3 or 4
* Current major untreated psychiatric disorder
* Unable to attend intervention in following 8 weeks due to medical or practical restrictions

Primary outcomes:
measure: Functional Assessment of Cancer Therapy
timeFrame: baseline to 2 months and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Alyson Moadel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein EM, Kolidas E, Moadel A. Do spiritual patients want spiritual interventions?: A qualitative exploration of underserved cancer patients' perspectives on religion and spirituality. Palliat Support Care. 2015 Feb;13(1):19-25. doi: 10.1017/S1478951513000217. Epub 2013 Aug 6.
Clinical trial NCT04517487: Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
Official title: Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Vaginoses
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Weizmann Institute of Science
First posted: 2020-08-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV. Recently, we completed a preliminary study in which we treated patients with recurrent and antibiotics-non-responsive, intractable BV, with VMT from healthy donors \[Lev-Sagie, Nature Medicine 2019\]. Four VMT recipients in this preliminary study featured a significant improvement of both clinical symptoms and dysbiotic vaginal microbiome composition and function, which persisted over a long follow-up period, while one recipient featured a partial remission.

The proposed study is designed as a placebo, randomized controlled trial, and is aimed to further assess whether VMT may serve as a viable option in symptomatic, intractable BV. In the suggested study, we plan to compare transplantation of: 1) vaginal fluid from healthy donors, and 2) autologous transplantation, of the patient's own vaginal fluid.


Eligibility criteria: Inclusion Criteria:

* Ages 18-50
* Recurrent BV, defined as ≥4 symptomatic episodes of BV during the last year, who require maintenance antibiotic treatment (twice weekly) in order to remain symptom-free, or if they experienced recurrence of BV in ≤ 2 months following antibiotic treatment, with a documented history of recurrent BV in the last year.
* Patients are otherwise healthy.
* Contraception use

Exclusion Criteria:

* Pregnancy or a planned pregnancy in the upcoming year
* Infection with HIV.
* Immunodeficiency status.

Primary outcomes:
measure: Clinical parameters- patient's complains
timeFrame: 12 months
measure: Laboratory parameters- Amsel criteria
timeFrame: 12 months
measure: Vaginal fluid microscopy
timeFrame: 12 months
measure: Microbiome composition
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Ahinoam Lev-Sagie
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lev-Sagie A, Goldman-Wohl D, Cohen Y, Dori-Bachash M, Leshem A, Mor U, Strahilevitz J, Moses AE, Shapiro H, Yagel S, Elinav E. Vaginal microbiome transplantation in women with intractable bacterial vaginosis. Nat Med. 2019 Oct;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6. Epub 2019 Oct 7.
Clinical trial NCT00046787: Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung Cancer
Official title: Phase II Study to Determine the Efficacy of OSI-211 (Liposomal Lurtotecan) Given on Days 1, 2 & 3 Every 3 Weeks in Patients With Recurrent Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SCLC
Carcinoma, Small Cell
Keywords: Small Cell Lung Cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: OSI Pharmaceuticals
First posted: 2002-10-04
Enrollment: 47
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 purpose of this study is to determine whether OSI-211 (Liposomal Lurtotecan) is an effective and safe treatment for patients with recurrent small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed recurrent small cell lung cancer.
* One prior treatment of chemotherapy.
* At least three weeks since last chemotherapy treatment and recovery from any related side effects.
* At least three weeks since last chest radiotherapy and at least 10 days since head irradiation and recovery from acute side effects.
* At least one target tumor less than or equal to 20 mm (or less than or equal to 10 mm on spiral CT-scan).
* If a patient has had previous documented Central Nervous System (CNS) involvement, only controlled disease is acceptable.

Exclusion Criteria:

* Superior vena cava syndrome.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Knoxville
country: United States
facility: Baptist Hospital Regional Cancer Ctr.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Clinical Trials Office
state: Tennessee
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
state: Nottinghamshire
city: Bebington
country: United Kingdom
facility: Clatterbridge Centre for Oncology
state: Wirral
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: London
country: United Kingdom
facility: Guys Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Northern Centre for Cancer Research, Newcastle General Hospital
Study officials:
References:
Clinical trial NCT03563287: Effects of LRYGB on Pharmacokinetics of Nine CYP Probe Drugs
Official title: Altered Metabolism of Nutrients and Drugs in Obesity and After Obesity Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Diabetes Research Foundation, Finland
name: Finnish Cultural Foundation
name: Kuopio University Hospital
name: Academy of Finland
First posted: 2018-06-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Due to anatomical and physiological changes caused by the Roux-en-Y gastric bypass (RYGB) bariatric surgery, drug bioavailability after the surgery can be altered. Therefore, post-operative dose adjustment in these patients can be required.

The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery on drug pharmacokinetics and cytochrome P450 (CYP) mediated metabolism using a cocktail of nine CYP probe drugs.

The cocktail covers nine main CYP enzymes: melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19/CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1), midazolam (CYP3A4).

The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity of CYPs are evaluated before and one year after LRYGB. In the study, the patients administering drug cocktail before surgery and 1 year after LRYGB are served as their own controls.


Eligibility criteria: Inclusion Criteria:

* BMI \> 40 kg/m2 or BMI 35-40 kg/m2 and a comorbidity or its risk factor, such as type 2 diabetes, hypertension, sleep apnea, osteoarthritis of weight bearing joints or polycystic ovarian syndrome;
* previous conservative treatment for obesity had been proven to be ineffective;
* patients were assigned to undergo LRYGB surgery
* patients are able to give a written inform consent.

Exclusion Criteria:

* smokers
* consuming alcohol more than 20 g per day were included in the study
* taking drugs which alter CYPs activity
* history of hypersensitivity to the drugs used in the cocktail

Primary outcomes:
measure: Probe cocktail drugs concentration-time profile in plasma and urine before LRYGB
timeFrame: baseline, 1 hour, 2 hour, 4 hour and 6 hour
measure: Probe cocktail drugs concentration-time profile in plasma and urine 1 year after LRYGB
timeFrame: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Secondary outcomes:
measure: Metabolic ratios of parent compounds and corresponding metabolites before LRYGB
timeFrame: baseline, 1 hour, 2 hour, 4 hour and 6 hour
measure: Metabolic ratios of parent compounds and corresponding metabolites 1 year after LRYGB
timeFrame: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
References: