louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04940377: Effect of the Genotype on Postoperative DVT
Official title: Postoperative Venous Thromboembolism Risk in 140,831 Surgical Patients - a Genetic Association Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 502505
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers followed by the UK biobank consortium

Brief summary: Postoperative Venous Thromboembolism Events (VTE) constitute a major source of morbidity and mortality after surgery. The aim of this study was to investigate whether commonly occurring Single Nucleotide Polymorphisms (SNPs) are associated with VTE in the surgical setting.

Detailed description: Data extracted from the participants in the UK Biobank collaborative study. Two cohorts will be examined:

1. Surgical cohort, consisting of all patients with a registered surgical procedure in the UK biobank repository
2. Validation cohort, consisting of all non-surgical patients in the UK biobank repository.

A GWAS approach will be used to associated commonly occurring single nucleotide polymorphisms (SNPs) with a postoperative venous thromboembolic event (VTE) within 30 days of a surgical procedure in the surgical cohort.

Findings from the surgical GWAS step will be replicated in the Validation cohort in order to assess whether the same SNPs drive both surgical and non-surgical VTE risk.

A final GWAS model will be fielded, correction for confounders including sex, age, smoking, obesity and open/minimal invasive surgery (surgical discovery GWAS only).

Eligibility criteria: Inclusion Criteria:

- All patients included in the UK biobank repository

Exclusion criteria:

- None

Primary outcomes:
measure: Postoperative VTE event
timeFrame: 30 days of a surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT02244177: Relationship of Essential Hypertension and Its Treatments on the Postoperative Pain Management: a Prospective, Observational, Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those patients enrolled will be divided into three groups as follows As the treatment and choice of drugs for hypertension is complex but internation guideline-oriented. We would like to enroll enough sample size in the hypertensive groups and subgroups.

1. Normaltension group (control group)
2. Hypertension without treatment
3. Hypertension with treatment as follows (according to subject's daily routine Tx, the PI not involved into the choice and further manitence of drugs) I. Hypertension with treatment with ACEI II. Hypertension with treatment with β blocker III. Hypertension with treatment with Ca channel blocker IV. Hypertension with treatment with diuretics

Brief summary: Numbers of postoperative PCA related side effects among three groups will be determined by comparing and analyzing frequency distributions. To determine whether the patients with hypertension require less post operative opiate analgesics than others, multivariate analysis with repeated measures will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. The major aim of the study is to test the hypothesis that the morphine comsumpted by the hypertension group is less than those of the normotension group. The minor aims for the study are the difference related to pain intensity, or the incidence of side effects among groups.


Eligibility criteria: Inclusion Criteria:

* 300 eligible subjects
* No contraindication for inhalation anesthesia
* Elective surgery
* Age between 20-75 y/o
* No contraindication for postoperative morphine pain control
* Female or male
* Essential hypertension stage I and II (140\<=SBP\<=180; 90\<=DBP\<=110)

Exclusion Criteria:

* Liver disease
* Renal disease
* Those who is presumed to go to ICU after surgery
* The patients with dementia or conscious disturbance
* Pregnancy or breast feeding
* Secondary hypertension
* events in recent 6 months myocardial infarction cardiac bypass surgery unstable angina cerebrovascular events congestive heart failure significant arrhythmia thoracic surgery

Primary outcomes:
measure: Pain
timeFrame: Post-operation Day1 to Day4
Secondary outcomes:
measure: Morphine consumption
timeFrame: Post-operation Day1 to Day4
Other outcomes:
measure: side effects
timeFrame: Post-operation Day1 to Day4
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
References:
Clinical trial NCT01293877: Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy
Official title: Laparoscopic Gastric Plication for Treatment of Morbid Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Keywords: Laparoscopy
obesity
gastric
restrictive
Lead sponsor: Bikkur Holim Hospital
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study must be performed in 100 patients suffering from morbid obesity, the procedure will be performed under general anesthesia doing two or three layers of suture to achieves gastric imbrication until transform the stomach to a sleeve. The patients will be followed during the time for 6 month, 1 year, two years and 5 years.

Detailed description: The patients will be selected with BMI more than 40, the operation will be primary between 18 to 60 years old. The patients will be informed about the procedure and different options. The patients will be in admission board for two or three days and any event will be recorded. the follow up will be recorded by the nurse, the surgeon and the dietitian, laboratory parameter includes CBC, T4,T3, TSH, ferrum, transferrin, ferritin, vit. B12, SMA, lipids, The end point will be the EBW achieved and events occurred.

Eligibility criteria: Inclusion Criteria:

* BMI 40 or more
* Age between 18-60 years old
* ASA score 1-2

Exclusion Criteria:

* BMI less than 40
* Severe illness
* Psychiatric disorders

Primary outcomes:
measure: Body Mass index loss
timeFrame: 6mont.
Secondary outcomes:
measure: Complications Quality of life
timeFrame: 6 month
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Bikur Holim Hospital
Study officials:
name: Sergio g Susmallian, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03523377: Overnight Fasting After Completion of Therapy: The OnFACT Study
Official title: Overnight Fasting After Completion of Therapy: The OnFACT Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer Survivors
Keywords: Fasting
18-199
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Rockefeller University
First posted: 2018-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The OnFACT study is a pilot randomized controlled trial of prolonged overnight fasting among adult survivors of childhood cancer.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test whether regularly not eating for at least 14 hours overnight ("intermittent fasting") is feasible and can improve blood sugar.


Eligibility criteria: Inclusion Criteria:

* Body mass index is ≥ 18.5 kg/m\^2
* History of treatment for cancer or related illness diagnosed at ≤ 25 years old
* Off cytotoxic therapy for primary cancer ≥ 2 years
* Not receiving cytotoxic therapy (chemotherapy, external beam radiation therapy) at the time of study enrollment
* History of radiation to the chest, abdomen or total body
* Current age ≥18 years
* English-speaking
* Personal phone with SMS text messaging capability
* Willingness to wear an mHealth device, such as a FitBit, for two 7-day periods
* Able to perform all study requirements

Exclusion Criteria:

* Use of any antidiabetic, weight loss, or appetite control medication
* Use of any other medication that could impact dietary intake, such as prednisone
* Currently fasts 12 hours or more by self-report
* Unable to fast due to medical reason such as pregnancy

Primary outcomes:
measure: Participation completion
timeFrame: 6 months
Secondary outcomes:
measure: measure of glucose metabolism
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Danielle Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01510977: Second Bowel Preparation for Colonoscopy Failure
Official title: The Outcome of a Second Preparation for Colonoscopy After Preparation Failure in the First Procedure: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Colonoscopy Failure
Poor Bowel Preparation
Keywords: colonoscopy
bowel preparation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due to bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second colonoscopy can be performed with either adding a colon cleansing solution immediately, or it can be performed after a few days with colon cleansing agent together with prokinetics. These different kinds of bowel preparations after first colonoscopy failure have not been compared.


Eligibility criteria: Inclusion Criteria:

* First colonoscopy failure due to inadequate bowel preparation

Exclusion Criteria:

* younger than 18 years old
* presence of inflammatory bowel disease
* pregnant
* lactating
* refusal

Primary outcomes:
measure: second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group)
timeFrame: one week
measure: second colonoscopy failure due to inadequate bowel preparation (PEG group)
timeFrame: within the same day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jeong-Sik Byeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05585177: Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve
Official title: A Randomized Controlled Trial of Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a prospective randomized controlled trial. Patients aged \<35 years with decreased clinical reserve function (AFC\<5, Follicle stimulating hormone \> 10miu/ml, Anti-mullerian hormone \< 1.1μg/L) and receiving IVF/ICSI assisted ovulation induction in our hospital were included in this study. After randomization using Excel(Microsoft Corporation, Albuquerque, USA), these patients were divided into two groups. Group A was the experimental group, which was treated with growth hormone for 3 months (2 units per day) before IVF/ICSI. Group B was the control group, which was directly assisted by IVF/ICSI.


Eligibility criteria: Inclusion Criteria:

1. Age \< 35 years;
2. AFC≤5
3. Follicle stimulating hormone \> 10miu/ml;
4. Anti-mullerian hormone \< 1.1μg/L

(2 out of 2-4 items can be met)

Exclusion Criteria:

1. Severe male factors: spermatozoa collected by testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA) was used for intracytoplasmic sperm injection (ICSI) cycle of single spermatozoa;
2. Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
3. Diabetes mellitus, insulin resistance;
4. chromosomal karyotype abnormality in either spouse;
5. Any pregnancy or contraindications of assisted reproductive technology;

Primary outcomes:
measure: Number of embryos
timeFrame: 4 months
Secondary outcomes:
measure: The number of oocytes retrieved
timeFrame: 4 months
measure: Clinical pregnancy rate
timeFrame: 5-8months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The affiliated Drum Towel Hospital of Nanjing University Medical School
name: Haixiang Sun, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00243477: MOTIV Study- Effect of Antidepressive Treatment by Escitalopram in Patients Undergoing Coronary Artery Bypass Grafting
Official title: MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Bypass
Surgery
Lead sponsor: Hopital Jean Minjoz
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2005-10-24
Enrollment: 368
Sex: ALL
Minimum age (years): 30
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 determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting

Detailed description: Depression is known to have an adverse effect on post-operative mortality and morbidity after coronary artery bypass grafting. Cardiac surgery is known to cause transient depression in patients. The purpose of this double-blind, randomized study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting. Treatment is given from 21 to 15 days pre-operatively until the 6th post-operative month. Morbidity as defined by the STS database as well as mortality is checked during 1 year.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective coronary artery bypass surgery
* \> 30 years old

Exclusion Criteria:

* Contra-indication to antidepressive treatment
* Already treated by antidepressive treatment
* Concomitant cardiac surgery as valve replacement etc.
* Patients having anticoagulation therapy
* Pregnant women
* Hepatic insufficiency

Primary outcomes:
measure: Postoperative morbi-mortality
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: Quality of life measured by SF-36
timeFrame: preoperatively and 1,3,6, and 12 months post-operatively
measure: Beck depression index (BDI) and Center for Epidemiologic Studies Depression (CES-D) Scale
timeFrame: preoperatively, and 1,3,6, and 12 months post-operatively.
Other outcomes:
Locations:
city: Besançon
country: France
facility: Sidney Chocron
state: Doubs
Study officials:
affiliation: Department of Cardiac Surgery - Besancon - France
name: Sidney Chocron, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT00984477: Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects
Official title: A Phase I, Exploratory Study to Assess the Pharmacokinetics of Single Oral Doses and a Single Intravenous Radiolabelled Microtracer Dose of AZD5122 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
healthy subjects
AZD5122
single oral dose
phase 1
Healthy volunteer phase 1 study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 100
Sex: MALE
Minimum age (years): 18
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 purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent.
* Normal physical examination, laboratory values, blood pressure and pulse
* Healthy male caucasian subjects

Exclusion Criteria:

* Subjects must not have any history of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body.
* Subjects must not have abnormal blood or urine tests for hsCRP, circulating neutrophils, haematocrit, haemoglobin or renal function
* Subjects must not have crystals or more than a trace of blood in their urine

Primary outcomes:
measure: Pharmacokinetic profile: concentration of AZD5122 in blood
timeFrame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Secondary outcomes:
measure: Pharmacokinetic profile: concentration of AZD5122 in urine
timeFrame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
measure: Measurement of the effect of AZD5122 on circulating neutrophils
timeFrame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
measure: Pharmacodynamic profile: assessment of various pharmacodynamic measures
timeFrame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.
Other outcomes:
Locations:
city: Nottinghamshire
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH
name: Andrew Sparrow, BSc, BMedSci, BM,BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01039077: Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding
Official title: Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 32
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: Gastric banding has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. We have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.


Eligibility criteria: Inclusion Criteria:

* BMI \> 40
* ASA Class I or II

Exclusion Criteria:

* Comorbid cardiac, pulmonary, renal, hepatic disease
* Bleeding disorder
* Previous gastric/esophageal surgery

Primary outcomes:
measure: weight loss
timeFrame: 1 month and 1 year post-operative
Secondary outcomes:
measure: quality of life
timeFrame: 1 week and 3 months post-operative
measure: perioperative complication rate
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Julio Teixeira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06681077: A Community Health Education Intervention for Increasing Community-driven Actions to Reduce the Cancer Burden in Western New York
Official title: I Can Join the Fight Against Cancer: An Intervention to Programmatically Build Grassroots Actions to Reduce the Cancer Burden
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This clinical trial evaluates a community health education intervention (I CAN) for increasing community-driven actions to reduce the cancer burden in Western New York. Engaging community members is a critical component of designing impactful programs to reduce the cancer burden. Leaders at the national, state, and local levels have all called for more community partnerships and engagement in design of health intervention and policies. The I CAN intervention is a workshop that includes a presentation outlining key concepts related to social network processes and the cancer burden in Western New York, a structured skill-building activity, and then empowering and motivating activities meant to cultivate momentum and excitement for action. This community health education intervention may be able to provide a formalized process for empowering and facilitating community members to take steps to reduce the community cancer burden.

Detailed description: PRIMARY OBJECTIVES:

I. Examine the feasibility of the I CAN intervention. II. Examine the acceptability of the I CAN intervention. III. Examine topic areas selected for action within participants' I CAN plans for action.

OUTLINE:

Participants attend an I CAN intervention workshop over 2 hours.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Able to participate in English

Exclusion Criteria:

* Unwilling or unable to follow protocol requirements

Primary outcomes:
measure: Demand
timeFrame: Up to 2 years
measure: Practicality
timeFrame: Up to 2 years
measure: Acceptability
timeFrame: UP to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Elizabeth Bouchard
role: PRINCIPAL_INVESTIGATOR
References: