louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01344603: Epidural and Cardiac Surgery
Official title: Epidural Analgesia in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: cardiac surgery
cardiac anesthesia
epidural
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2011-04-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing cardiac surgery

Brief summary: In the present study the investigators test the hypothesis that the epidural anesthesia added on the general anesthesia is able to improve patient's outcome.


Eligibility criteria: Inclusion Criteria:

* patients undergoing cardiac surgery
* adult (\>18y)
* sternotomy

Exclusion Criteria:

* abnormal coagulation profile
* antiplatelet medications (other than aspirin)
* ongoing anticoagulation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Università Vita-Salute San Raffaele
state: MI
Study officials:
References:
Clinical trial NCT04138303: Exercise and Nutrition on Obese Microbiome
Official title: The Effects of a Calorie-Restrictive Low-Carbohydrate Diet Versus an Unrestrictive Ancestral Diet on Microbiota and Cardiometabolic Disease Markers of Obese Individuals Performing an Intense Exercise Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the effects nine weeks of intense exercise training will have on weight, inflammation, and intestinal bacteria composition of overweight and obese adults.


Eligibility criteria: Inclusion criteria:

1. Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30).
2. Individuals who volunteer for the 54-day exercise program.
3. Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease.
4. Individuals who are not taking antibiotics and have not taken antibiotics within 3 months.
5. Individuals who are not taking probiotics.
6. Individuals who are not taking Metformin.
7. Individuals who are cleared by their physician to perform strenuous exercise.
8. Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed.
9. Individuals who are between 18 and 60.

Exclusion criteria:

1. Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.

Primary outcomes:
measure: Change in fecal microbiota diversity
timeFrame: Baseline, 9 weeks
measure: Change in Bacteriodetes/Firmicutes ratio
timeFrame: Baseline, 9 weeks
measure: Percent change in fecal microbiota composition
timeFrame: Baseline, 9 weeks
measure: Change in inflammatory markers
timeFrame: Baseline, 9 weeks
measure: Change in leptin/adiponectin ratio
timeFrame: Baseline, 9 weeks
measure: Correlation of serum triglycerides with leptin levels
timeFrame: Baseline, 9 weeks
measure: Change in body weight
timeFrame: Baseline, 9 weeks
measure: Change in resting metabolic rate
timeFrame: Baseline, 9 weeks
measure: Change in body composition
timeFrame: Baseline, 9 weeks
measure: Change in waist circumference
timeFrame: Baseline, 9 weeks
measure: Change in blood pressure
timeFrame: Baseline, 9 weeks
measure: Change in visceral fat
timeFrame: Baseline, 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Wesley Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02531503: Predicting Factors for Asthma Remission in Children
Official title: Predicting Factors for Asthma Remission in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma remission
Predicting factors
Children
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-08-24
Enrollment: 200
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The children who were diagnosed as having asthma at pediatric allergy clinic were recruited.

Brief summary: The purpose of this study is to determine the predicting factors for asthma remission in children.

Detailed description: Children who were diagnosed as having asthma during the period of 2004-2007 and reevaluated in 2015.

Eligibility criteria: Inclusion Criteria:

* Children who were diagnosed as having asthma during the period of 2004-2007.

Exclusion Criteria:

* Patients who had underlying disease with chronic respiratory disease (ex. tuberculosis, bronchiectasis), primary immunodeficiency, other seriously interfering diseases
* Medical records have been lost.

Primary outcomes:
measure: Number of factors associated with asthma remission
timeFrame: 18 months
Secondary outcomes:
measure: Asthma remission rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Division of Allergy and Immunology, Department of Pediatrics,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00887003: Epidural Study of Patients With Chronic Lower Back Pain
Official title: Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: epidural
volume
dose
pain relief
steroid
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine 4 different epidural dosing regimes of local anaesthetic solution in a series of 3 epidural injections over a period of 12 months to determine the optimum dose of anaesthetic solution for pain relief and to determine the nature of any adverse events by measuring anxiety and depression, functionality and any side effects of the medication.

Detailed description: To determine the optimum dose of local anesthetic and the optimum volume of injected solution when used in an epidural steroid injection being given for pain relief to patients with chronic lower back pain, using pain scores as an assessment tool.

Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* lower back pains \> 6 months
* no lumbar epidural in past 6 months
* no previous back surgery
* written informed consent to participate in study

Exclusion Criteria:

* acute lower back pain
* pregnancy
* significant psychiatric disease
* local or systemic infection
* coagulopathy/anticoagulant therapy
* bleeding diathesis
* presently enrolled in another study

Primary outcomes:
measure: The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief.
timeFrame: Pain scores will be measured at 6 time intervals throughout the study period, prior to 1st injection, 30 minutes post 1st injection, prior to 2nd injection and 3rd injections and at 3 and 6 month post the three month injection.
Secondary outcomes:
measure: Secondary outcomes will be scores on the Oswestry low back pain disability scale and the Hospital anxiety and depression scale correlated with treatment outcomes and adverse events.
timeFrame: Oswestry scores and HADS scores will be calculated at 5 time periods throughout the study period, prior to 1st, 2nd, and 3rd injections and at 3 and 6 month post the three month injection.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Julian Mulcaster, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06027203: Transperineal Versus Transrectal Prostate Biopsy
Official title: Freehand Transperineal Prostate Biopsies Without Antibiotic Prophylaxis - the New Gold Standard?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate biopsy
prostate cancer
transperineal
transrectal
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 923
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All men who underwent a transrectal prostate biopsy between January 2017 and December 2018, and/or a transperineal prostate biopsy between January 2021 and December 2022 in the Urology department of MUMC+

Brief summary: Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal prostate biopsies (TR-PB) are commonly performed, however disadvantages include the requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal prostate biopsies (TP-PB). Guidelines still recommend the use of AP for TP-PB due to the limited evidence regarding complication rates after their omission. However, the rising rates of antibiotic resistance is of concern. The aim of this study was to compare the complication and detection rates of freehand TP-PB without AP versus TR-PB with AP.

Methods: This single center retrospective study was performed in an academic hospital. TP-PB were introduced in 2019 and implemented as the main technique by late 2020. To compare the two techniques, data was collected for freehand TR-PB with AP between 2017-2018 and freehand TP-PB without AP between 2021-2022. The data from 2019 and 2020 were excluded to rule out the effects of the initial learning curve during the transition period. Primary outcome measure was post-biopsy complications occurring within 2 weeks, focusing on infectious complications. Secondary outcome measures were detection rates and upgrading/reclassification in the repeat biopsy in active surveillance (AS). Statistical analysis was performed using a Fisher exact or Chi-Squared test.


Eligibility criteria: Inclusion Criteria:

* men who underwent prostate biopsy between 2017-2018 (transrectal)
* men who underwent prostate biopsy between 2012-2022 (transperineal)

Exclusion Criteria:

* positive urine culture before biopsy
* patients in the transrectal biopsy group who did not take the prescribed course of antibiotic prophylaxis
* incomplete medical dossier where the occurrence of a complication could not be assessed

Primary outcomes:
measure: Complications
timeFrame: 2 weeks
Secondary outcomes:
measure: Detection rate
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
References:
Clinical trial NCT02083003: Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
Official title: Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Surgery
Keywords: Pain
Polyamine
Cholecystectomy
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine) potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has shown antinociceptive properties. This research aims at evaluating analgesic properties of polyamine-low diet after laparoscopic cholecystectomy performed in an ambulatory setting.


Eligibility criteria: Inclusion Criteria:

* laparoscopic cholecystectomy
* ambulatory surgery
* agreeing to follow a polyamine-low diet with Polydol plus

Exclusion Criteria:

* Pregnancy
* Contra-indication to a non-steroidal anti-inflammatory, to tramadol
* Intolerance to cow proteins
* Diabetic patients
* Poor understanding of the French language.

Primary outcomes:
measure: Pain intensity for the 7 days
timeFrame: 7 days
Secondary outcomes:
measure: Pain scores measured on the day of surgery,
timeFrame: 12 hours
measure: frequency of impeded hospital discharge the day of surgery
timeFrame: 24 hours
measure: Each day pain
timeFrame: 7 days
measure: Quality of life
timeFrame: 7 days
measure: Residual pain
timeFrame: 30 days
measure: Blood levels of polyamine
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital de la Croix Saint-Simon
state: Hauts de Seine
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04887103: The Effect of Hot Water Application in Pregnant Women With Restless Legs Syndrome: A Randomised Controlled Study
Official title: The Effect of Hot Water Application in Pregnant Women With Restless Legs Syndrome: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Pregnancy Related
Keywords: Restless legs syndrome
pregnancy
hot water application
nursing
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 29
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: pretest-posttest randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Backgraund and Purpose: The prevalance of restless legs syndrome (RLS) in pregnants varies between 15.4-26.0 percent. As well as pharmacological methods, there are studies reporting that non-pharmacological methods reduce RLS symptoms but the number of studies conducted with pregnants is limited. This study was conducted to determine the effect of hot water application to the legs of pregnants with RLS on their complaints.

Materials and methods: The study is a pretest-posttest randomised controlled. Among the pregnants whose IRLS score was more than 11, 13 people to the intervention group and 16 people to the control group were randomised. The data were collected using Personal Information Form, International RLS Study Group Diagnostic Criteria, and the International RLS Rating Scale (IRLS). Hot water application was made of intervention group. The application was made for 20 minutes before bedtime for seven days. No application was made in the control group other than routine care and follow-up. Chi-square test, descriptive statistics and dependent/independent samples t tests were used to assess the data. The value of p\<0.05 was accepted as significant.


Eligibility criteria: Inclusion Criteria:

* in the gestation age of 28-32 weeks,
* literate,
* according to RLS Diagnostic Criteria and had 11 and higher severity according to International RLS Rating Scale (IRLS)

Exclusion Criteria:

* risky pregnancies,
* communication problems,
* any chronic and psychiatric disease
* were using antipsychotic, antidepressant, antihistaminic, and antiemetic drugs,
* had history of deep vein thrombosis

Primary outcomes:
measure: RLS Severity Rating Scale
timeFrame: change from baseline score at the end of one week
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Talas
Study officials:
References:
Clinical trial NCT03533803: Indomethacin Prior to Difficult Embryo Transfer is it a Solution?
Official title: Indomethacin Prior to Difficult Embryo Transfer is it a Solution?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Difficult Embryo Transfer
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Nile Ivf Center, Cairo, Egypt
First posted: 2018-05-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: IVF/ICSI patients who had difficult mock embryo transfer on the day of ovum pick up. Will be randomly assigned into two groups; group A will receive 100mg indomethacin rectal suppository 1-2 hours before ET and group B will not receive indomethacin


Eligibility criteria: Inclusion Criteria:

* Infertile patients undergoing IVF cycle with difficult mock embryo transfer
* Early follicular FSH level ≤10 IU/L.
* Tubal, male infertility and unexplained causes of fertility will be recruited.
* Fresh ET.

Exclusion Criteria:

* Repeated IVF failure.
* Past history of allergy to NSAID, bronchial asthma , peptic ulcer or inflammatory bowel disease.

  * Easy mock embryo transfer.

Primary outcomes:
measure: Implantation rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 weeks
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Nile IVF center
Study officials:
affiliation: Cairo University
name: Sarwat Ahawany, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03046303: Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial
Official title: Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrostomy Complications
Keywords: ERAS,gastric cancer
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 400
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: This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.


Eligibility criteria: Inclusion Criteria:

* (1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score \< III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy.

Exclusion Criteria:

* patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 mL);and patients opting out of the study.

Primary outcomes:
measure: clinical parameters
timeFrame: One week after operation
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT00845403: Antigen-specific Immune Response to Hepatitis B Virus in Utero
Official title: Antigen-specific Immune Response to Hepatitis B Virus and Influenza A (H1N1 Strain) in Utero
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Keywords: Hepatitis B carrier
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HBsAg+ mothers are the source of possible in utero infection.Thus, the cord blood collected from these mothers after delivery would provide information about the cause of HBV chronicity in Asian patients and about the management of baby born from HBsAg+ mothers.

Brief summary: This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers.

Detailed description: Despite the development of an effective preventive HBV vaccine, the spread of HBV virus continue, particularly in Asia, where the majority of HBV infection is acquired at birth by vertical transmission from mother to baby. HBV vertical transmission has been hypothesized to cause immune tolerance to HBV and thus promoting the subsequent HBV chronicity. Such hypothesis has never been tested and nothing is known about HBV-specific adaptive immune response occurring before birth in baby born form HBV chronically infected mothers. This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers. The characterization of the HBV immune response in utero will provide informations about the cause of HBV chronicity in Asian patients in the management of baby born from HBsAg+ mothers.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with HBsAg+

Exclusion Criteria:

* Pregnant women without HBsAg+

Primary outcomes:
measure: Anti - viral immune response in cord blood of newborn infants born to HBV+ mothers
timeFrame: At birth (baseline)
Secondary outcomes:
measure: Expression of immune genes from immune cells
timeFrame: At birth (baseline)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Yap Seng Chong, MBBS
role: PRINCIPAL_INVESTIGATOR
References: