louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03952442: Nutrition Education Program for Postoperative Patients With Gastric Cancer
Official title: The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Postoperative Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Nutrition Disorders
Keywords: gastric cancer
nutrition
health education
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 200
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: Using randomized control study, explore the effect of standardized nutrition education program on the nutrition status and life quality of patients with gastric cancer after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients are diagnosed with gastric cancer and receive operation.
* Patients need nutrition support treatment
* Informed consent.

Exclusion Criteria:

* Critical patients or stage IV
* Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke.
* Unconscious or psychiatric patients
* Patients with communication problems

Primary outcomes:
measure: risk of malnutrition
timeFrame: Week 0
measure: risk of malnutrition
timeFrame: Week 12
measure: BMI
timeFrame: Week 0
measure: BMI
timeFrame: Week 12
measure: albumin
timeFrame: Week 0
measure: albumin
timeFrame: Week 12
measure: Quality of Life (QOL)
timeFrame: Week 0
measure: Quality of Life (QOL)
timeFrame: Week 12
Secondary outcomes:
measure: physical function status
timeFrame: Week 0
measure: physical function status
timeFrame: Week 12
measure: Knowledge-Attitude-Practice
timeFrame: Week 12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT06324942: Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section.
Official title: Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Pain, Postoperative
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital.

Detailed description: Randomized clinical trial of Transversus Abdominis Plane Block (TAP block) at Cesarean Section.

Eligibility criteria: Inclusion Criteria:

* ASA status II to III
* All patients undergoing elective CS under regional anesthesia at any gestational age.

Exclusion Criteria:

* - Known drug allergy to local anesthetics
* Planned general anesthetic
* NSAID use contraindicated post partum
* Chronic pain disorder or chronic narcotic use/dependence
* Planned vertical abdominal incision
* Planned Cesarean Hysterectomy.
* Placenta Previa or suspected Placenta Accreta

Primary outcomes:
measure: Post operative Pain
timeFrame: 12 hours post op
Secondary outcomes:
measure: Time to first request for rescue analgesia in hours
timeFrame: 48 hours post op
measure: Post operative Opioid use
timeFrame: up to 48 hours post op.
measure: Time from surgery to discharge from hospital
timeFrame: Up to discharge from hospital, usually 1-3 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Stephen Wood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00785642: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Safety.
Official title: Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility criteria: Inclusion criteria:

* Integral skin test in the region;
* Use of cosmetic product of the same category;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;
* Atopic antecedent or allergic to cosmetic product;
* Active cutaneous disease in the evaluation area;
* Diseases which cause immunology decrease, such as diabetes and HIV;
* Endocrinal pathologies;
* Intense solar exposure 15 days before the evaluation;
* Treatment until four months before the selection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
timeFrame: From the treatment start to the end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT04399642: Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty
Official title: Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty: a Prospective, Randomized Clinical Survey
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infection
Keywords: vancomycine
hip arthroplasty
knee arthroplasty
hip revision arthroplasty
knee revision arthroplasty
Lead sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 1832
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 purpose of this study is to compare infection rates when patients, elected for primary or aseptic revision THA / TKA, have a single intravenous antibiotic dose versus one single intravenous antibiotic dose in combination with intra-articular antibiotics. This is a prospective, randomized clinical survey on selected outcome measurements on 1834 subjects who will be recruited in a period of about 2 years.

Detailed description: Group A: patients receiving single dose of IV cefazolin 10-60 minutes before incision.

Group B: patients receiving a single dose of IV cefazolin 10-60 minutes before incision + a single dose of intra-articular vancomycin powder before articulation (hip or knee) closure.

Eligibility criteria: Inclusion Criteria:

* Standard criteria for the implantation of primary total hip or knee replacement
* Revision of an aseptic THA or TKA.
* Adults \>18 years of age
* Diagnosis of Osteoarthrosis (OA), Osteonecrosis (ON), Arthritis; or aseptic loosening of THA/TKA.
* Subject is willing to consent to participate in the study
* Subject is available for follow-up through at least 2 years
* Subject has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk.
* Subject who are fluent in English and / or French and able to understand their role in the study

Exclusion Criteria:

* Active, local infection or systemic infection.
* Participation in any other pharmaceutical, biologic or medical device clinical investigation
* Subjects with known allergy to vancomycin
* Subjects unable to consent
* Patient with skin pathology

Primary outcomes:
measure: Acute Infection rate
timeFrame: 3 months
Secondary outcomes:
measure: Long-term infection rate
timeFrame: 2 years
measure: Risk factor
timeFrame: 2 years
measure: Primary vs revision
timeFrame: 2 years
measure: Surgery time
timeFrame: 2 years
Other outcomes:
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: baseline, 1 year
measure: EQ-5D-5L
timeFrame: baseline, 1 year
Locations:
city: Montréal
country: Canada
facility: Hopital Sacré-Coeur de Montreal
state: Quebec
Study officials:
affiliation: CIUSSS du Nord de l'Île de Montreal
name: Benoit Benoit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04378842: COVID-19 and ICU-acquired MDR Bacteria
Official title: Impact of SARS-CoV-2 Infection on the Incidence of ICU Acquired Colonization Related to Multidrug-resistant Bacteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Critical Illness
Keywords: Covid-19
Critically ill patients
multidrug-resistant bacteria
infection
colonization
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 368
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 admitted to intensive care

Brief summary: This multicenter before-after study aimed to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired multidrug resistant (MDR) bacteria.

Detailed description: Multicenter observational before-after study, aiming to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired colonization and infection related to MDR bacteria.

Eligibility criteria: Inclusion Criteria:

* Expected ICU stay \> 48 hours
* Rectal and nasal BMR screening performed \< 48 hours after admission to ICU

Exclusion Criteria:

* Patients aged \< 18 years Refusal to take part in the study ICU-stay \< 48 hours At least a second rectal and nasal BMR screening was not performed prior to ICU discharge (a posteriori exclusion criterion).

Primary outcomes:
measure: Cumulative incidence of ICU-acquired colonization related multidrug resistant bacteria
timeFrame: from D3 until day 28 after ICU admission
Secondary outcomes:
measure: Cumulative incidence of ICU-acquired infection related to multidrug resistant bacteria
timeFrame: from D3 until day 28 after ICU admission
measure: Mechanical ventilation duration
timeFrame: from D1 until day 28 after ICU admission
measure: mortality
timeFrame: from D1 until day 28 after ICU admission
measure: length of stay in intensive care unit
timeFrame: from D1 until day 28 after ICU admission
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Béthune
country: France
facility: Ch Bethune
city: Jossigny
country: France
facility: Grand Hopital de L'Est Francilien
city: Lens
country: France
facility: CH LENS
city: Lille
country: France
facility: Hôpital Roger Salengro, ICU, CHU Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: University Hospital, Lille
name: Saad Nseir, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00563342: Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients
Official title: Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: End Stage Renal Failure, Hemodialysis
Keywords: Ethanol, lock solution, infection
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2007-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis.

The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial or complete occlusion or infection associated with dialysis catheter.

As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total ultrafiltration)


Eligibility criteria: Inclusion Criteria:

* Patients of both genders, over 18 years,
* Chronic hemodialysis 3 times a week, with two tunnel silicone catheters since at least 15 days,
* Written informed consent
* Social security

Exclusion Criteria:

* Antibiotic therapy during selection phase,
* Partial or complete catheter occlusion during selection phase,
* Venous pressure at dialysis connection \> 300 mmHg,
* Known allergy to ethanol,
* Patient involved in any other clinical trial or in the exclusion period
* Severe co-morbidity
* Acute or chronic infectious disease
* Evolutive neoplasia,
* HIV, HCV positive serology at inclusion,
* Scheduled surgery

Primary outcomes:
measure: The catheters dysfunction rate
timeFrame: as partial or complete occlusion or infection associated with dialysis catheter
Secondary outcomes:
measure: The dialysis quality is also examined (urea reduction rate, total ultrafiltration)
timeFrame: as partial or complete occlusion or infection associated with dialysis catheter
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Lacarin
Study officials:
name: Bertrand Souweine, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coupez E, Timsit JF, Ruckly S, Schwebel C, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Darmon M, Boyer A, Azoulay E, Bouadma L, Lautrette A, Souweine B. Guidewire exchange vs new site placement for temporary dialysis catheter insertion in ICU patients: is there a greater risk of colonization or dysfunction? Crit Care. 2016 Jul 30;20(1):230. doi: 10.1186/s13054-016-1402-6.
Clinical trial NCT05840042: Epidemiology and Risk Factors of Uterine Fibroids in China
Official title: Epidemiology and Risk Factors of Uterine Fibroids in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Uterine Fibroid
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Women's Hospital School Of Medicine Zhejiang University
name: Tongji Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: West China Hospital
name: Fourth Hospital of Shijiazhuang City
First posted: 2023-05-03
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study population is women aged more than 18yrs with or without uterine fibroids from five regions of China. The study time period will conduct from May 1, 2023 - November 30, 2025 to allow for 6 months pre-index for evaluating baseline demographic and clinical characteristics and 24 months post-index, ensuring a minimum of one years follow-up.

Brief summary: Uterine fibroids are the most common form of benign uterine tumors in the uterine muscle layer, which had a certain rate of malignancy, but it is rare. The prevalence of uterine fibroids estimates range from 4.5% to 68.6% depending on study population and diagnostic methodology. The prevalence of fibroids has been historically underestimated by epidemiologic studies which focused mainly on symptomatic women, leaving behind a large population of asymptomatic women and women who underreport their symptoms. What investigators don't know was which women who have fibroids will develop clinical symptoms and which women who have an operation of myomectomy will relapse. The purpose of this study is to investigate the prevalence, incidence and risk factors for the development of uterine fibroids in Chinese women.


Eligibility criteria: Inclusion Criteria:

* Current place of residence≥ 6 months;
* No serious mental illness or mental abnormality;
* Those who agree to participate in this survey and cooperate in completing the questionnaire.

Exclusion Criteria:

-

Primary outcomes:
measure: Prevalence of uterine fibroids in China
timeFrame: Baseline
Secondary outcomes:
measure: Incidence of uterine fibroids in China
timeFrame: Two follow-ups over a three-year period
measure: Risk factors of development of uterine fibroids in China
timeFrame: Two follow-ups over a three-year period
Other outcomes:
Locations:
Study officials:
affiliation: Huazhong University of Science and Technology
name: SHIXUAN WANG, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03236142: DS vs SIPS-Bariatric Surgery Comparasion
Official title: The Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) Results in Less Nutritional Deficiencies Than the Standard Duodenal Switch (DS) Operation: A Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: bariatric
duodenal switch
DS
weight loss surgery
SIPS
Single Anastomosis
Lead sponsor: Reading Health System
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to answer the question of whether the single anastomosis, 300 cm loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less nutritional and surgical risks than the standard duodenal switch (DS) operation. Please note, this study does not provide a stipend or coverage for surgery.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of 40 to 65
* Agree to not use weight loss medications for the length of the study
* Compliance with standards of surgical program

Exclusion Criteria:

* Patients with a history of previous bariatric surgery except for patients who have had a previous gastric sleeve
* Previous complex abdominal surgery
* Poorly controlled medical or psychiatric disease

Primary outcomes:
measure: Vitamin A Deficiency
timeFrame: 36 months post surgery
Secondary outcomes:
measure: Vitamin D, zinc, copper, and albumin
timeFrame: 36 months post surgery
measure: Frequency of stools
timeFrame: 36 months post surgery
measure: Length of Operation
timeFrame: Date of operation
measure: Percentage of excess weight lost
timeFrame: 36 months post surgery
measure: Body Mass Index (BMI)
timeFrame: 36 months post surgery
Other outcomes:
Locations:
city: West Reading
country: United States
facility: Reading Health Physician Network Weight Management Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01940042: the Effect of Simple Clinical Maneuver on Shoulder and Abdominal Pain a Laparascopic Gynecological Surgery:a Prospective Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of CO2 Was Removed by Means Trandelenburg Position at Laparascopic Surgery
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2013-09-11
Enrollment: 110
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The investigators think that a simple maneuver at laparascopic surgery to reduce the postoperative pain.


Eligibility criteria: Inclusion Criteria:

1. females aged 15-65 years,
2. American Society of Anesthesiologists (ASA) physical status classification I-III
3. no previous laparotomy(major abdominal surgery).
4. need a laparascopic surgery

Exclusion Criteria:

1. required hospitalization after the laparoscopic surgery,
2. the procedure required conversion to laparotomy
3. if a 48-hour follow-up was not feasible

Primary outcomes:
measure: postoperative 12. hour VAS pain score
timeFrame: 12 hour
Secondary outcomes:
measure: postoperative analgesic requırements
timeFrame: 48 hours
Other outcomes:
measure: postoperative shoulder pain score
timeFrame: 7 days
Locations:
city: Izmir
country: Turkey
facility: Tepecik Education and Research Hospital
Study officials:
affiliation: tepecik education and research hospital
name: isa aykut özdemir, m.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esin S, Culha ZK, Kara OF, Yildirim H. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 Aug;112(2 Pt 1):380; author reply 380. doi: 10.1097/AOG.0b013e318182cb6e. No abstract available.
citation: Gungorduk K, Asicioglu O, Ozdemir IA. Effect of the pulmonary recruitment maneuver on pain after laparoscopic gynecological oncologic surgery: a prospective randomized trial. J Gynecol Oncol. 2018 Nov;29(6):e92. doi: 10.3802/jgo.2018.29.e92.
Clinical trial NCT02912442: Thyroid Autoimmunity and Reproductive Failure in Danish Women
Official title: Thyroid Autoimmunity and Reproductive Failure - a Study of Autoimmunity in Association With Treatment Outcome in Infertile Danish Women With Infertility or Recurrent Miscarriages.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid
Infertility
Autoantibodies
Autoimmunity
Pregnancy Loss
Keywords: thyroid
infertility
autoimmunity
pregnancy loss
autoantibodies
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 1200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred to the infertility clinic

Brief summary: The present Ph.D.-study investigates the mechanisms behind the association between thyroid autoimmunity and reproductive failure.


Eligibility criteria: Inclusion Criteria:

* Women followed in the Fertility Clinic

Exclusion Criteria:

* Pregnancy at time of blood sampling. Immune-suppressive ⁄modulatory treatments. Women referred for oocyt donation, genetic testing, and hepatitis and HIV-positivity

Primary outcomes:
measure: Live birth
timeFrame: 2011-2015
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: