louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01103752: Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up
Official title: Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2010-04-15
Enrollment: 225
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing fast-track knee or hip replacement surgery at one of the hospitals participating (Hidovre, Holstebro, Hørsholm, Århus)

Brief summary: The aim of this study is to quantify the incidence of postoperative cognitive dysfunction in the elderly patient (\>60y) after total hip or knee replacement surgery. The hypothesis is that the fast-track methodology with a mean hospital stay less than 3 days will help to minimize this reduction in memory and concentration.


Eligibility criteria: Inclusion Criteria:

* 60 years of age or above
* ASA classification 1-4
* undergoing fast-track hip or knee replacement

Exclusion Criteria:

* anaesthesia within the past 90 days
* daily consumption of sleep or anxiety medication
* more than 35 units of alcohol per week
* lack of proper verbal and reading skills, Danish
* Serious hearing or visual impairment
* Mini mental status evaluation (MMSE) \< 24
* Parkinsons Disease or other neurological disease causing functional impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Lundbeck Centre for fast-track hip/knee surgery
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene Krenk, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00538200: Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial
Official title: A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Outcomes in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Nutrition
COPD
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: University Hospital Southampton NHS Foundation Trust
First posted: 2007-10-02
Enrollment: 85
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine the best form of dietary intervention to undernourished individuals with COPD.

The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age \>18 years
* At risk of malnutrition
* Competent to provide written informed consent and able to answer questions
* Able to eat and drink
* Willingness to take part in the trial and to follow the trial protocol
* FEV1 \<80% predicted and FEV1/FVC \<0.7

Exclusion Criteria:

* Requirement for tube or parenteral nutrition
* Galactosemia
* Receiving current oral nutritional supplementation
* Palliative care
* Chronic renal disease requiring dialysis
* Liver failure
* Malignancy
* Participation in other studies
* Bronchiectasis
* Those already under the care of a dietitian

Primary outcomes:
measure: The primary outcome measure is Quality of Life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals NHS Trust
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Marinos Elia, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01974700: Seizure Prophylaxis in Aneurysm Repair
Official title: Seizure Prophylaxis in Aneurysm Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Intracranial Aneurysms
Seizures
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 17
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: Seizures are a potential complication of surgical repair of intracranial aneurysms. In order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative period, however, such practice is not supported by clinical data. Retrospective review found the incidence of postoperative seizures was higher in those who received anti-epileptics versus those who did not. The goal is to examine the utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical repair of unruptured intracranial aneurysms.


Eligibility criteria: Inclusion Criteria:

1. Adult (≥18 years)
2. Presence of intracranial aneurysm (without rupture)
3. Treating surgeon has recommended surgical repair of the aneurysm.

Exclusion Criteria:

1. History of seizures within last 10 years
2. History of epilepsy
3. History of prior stroke
4. Currently prescribed medication with anti-epileptic activity (keppra,dilantin, tegretol, lamictal, topamax, etc.)
5. Brain tumor
6. Pregnant or nursing woman
7. Known levetiracetam allergy

Primary outcomes:
measure: Incidence of Seizure
timeFrame: 6 mo - 1 Year from Operative Procedure
Secondary outcomes:
measure: Number of Participants Who Returned to Daily Activities.
timeFrame: 6 months - 12 months
measure: Number of Participants Who Returned to Work
timeFrame: 6 months - 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT04919200: Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease
Official title: Measurement of the Total Lung Volume Using Optimized Single-breath Helium Dilution Method in Patients With Obstructive Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Lung Disease
Keywords: obstructive lung disease
total lung capacity
the single-breath helium dilution
Whole-body plethysmography
correction equation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 628
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 628 patients with obstructive lung disease simultaneously subjected to the single-breath helium dilution method and Whole-body plethysmography tests in Second Affiliated Hospital of Zhejiang University School of Medicine were continuously enrolled from January 2018 to December 2020

Brief summary: Whole-body plethysmography (WBP) is the gold standard for measuring lung volume, but its clinical application is limited because it requires expensive equipment and is complicated to use. Studies have shown that the single-breath helium dilution (SBHD) method, which is commonly used in clinical practice, significantly underestimates lung volume in patients with obstructive lung disease (OLD). Therefore, by comparing the differences in lung volume measured by the SBHD method and WBP in patients with different severities of obstructive lung disease, we aim to establish a correction equation for the SBHD method to determine the total lung volume in obstructive lung disease patients.


Eligibility criteria: Inclusion Criteria:

(1) age 18-80 years and (2) in line with the ATS/ERS definition of obstructive lung disease.

Exclusion Criteria:

(1) contraindications for spirometry, pulmonary diffusion function test, and WBP and (2) history of lung surgery and recent history of chest trauma.

Primary outcomes:
measure: Establishment of the TLC-SBHD correction equation
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT05939700: Mavacamten Pregnancy Surveillance Program
Official title: Mavacamten Pregnancy Surveillance Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breastfeeding
Hypertrophic Cardiomyopathy
Pregnancy Related
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-07-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals 15 years of age or older who are exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding.

Brief summary: The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.


Eligibility criteria: Inclusion Criteria:

* Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first)
* At least 15 years of age or older at the time of enrollment
* Informed consent or institutional review board/ethics committee-approved waiver of informed consent

Exclusion Criteria:

- None

Primary outcomes:
measure: Pregnancy outcomes
timeFrame: Up to 10 months
measure: Fetal/neonatal/infant outcomes
timeFrame: Up to 12 months post pregnancy outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: The Mavacamten Pregnancy Surveillance Program, PPD Inc
state: North Carolina
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02395900: The Effects of Flaxseed Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease
Official title: The Effects of Flaxseed Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of Flaxseed supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive placebos or 30 grams Flaxseed powder for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40
* Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

* Diabetes
* Taking any kind of antibiotics two weeks before recruitment
* History of alcohol consumption
* pregnancy or lactation
* Professional athletes
* Other liver disease (viral/etc)
* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
* Following program to lose weight in recent 3 mo
* A history of hypothyroidism or Cushing's syndrome

Primary outcomes:
measure: Alaninaminotransferase (ALT)
timeFrame: 12 weeks
measure: Liver fibrosis
timeFrame: 12 weeks
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04290000: Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies
Official title: Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies in Montpellier University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma and Acute Lymphoblastic Leukemia
Keywords: CAR T-Cell
lymphoma
Acute Lymphoblastic Leukemia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital

Brief summary: Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukemia leaded to 2 authorized medication: Yescarta and Kymriah. Despite impressive outcomes in 3 phase II studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.This can be explained by a low expansion, functional alteration or short persistence of infused cells. Determination of reasons for treatment failure is the first step for optimization of this therapeutics. This project aims to bank blood samples from a cohort of patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital. Clinical data related to samples will be collected. This samples will be used to determine factors influencing efficacy of CAR-T cells treatments.

Detailed description: Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukema leaded to 2 authorized medication: Yescarta and Kymriah. Despite impressive outcomes in 3 phase II studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.This can be explained by a low expansion, functional alteration or short persistance of infused cells. Determination of reasons for treatment failure is the first step for optimization of this therapeutics. This project aims to bank blood samples from a cohort of patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital. Clinical data related to samples will be collected. This samples will be used to determine factors influencing efficacy of CAR-T cells treatments.

Eligibility criteria: Inclusion Criteria:

* patient treated by CAR-T cell at the University Hospital of Montpellier

Exclusion Criteria:

* refusal to sign consent form
* pregnant woman
* major protected

Primary outcomes:
measure: Constitution of biological samples from patient treated with CAR T cells
timeFrame: up to 15 years
Secondary outcomes:
measure: patient survival
timeFrame: up to 15 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Département d'hématologie clinique
Study officials:
References:
Clinical trial NCT03326700: Effects of Hernia Repair on Men's Sexual Functions
Official title: Effects of Laparoscopic Totally Extraperitoneal and Lichtenstein Hernia Repair on Men's Sexual Functions and Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Men
Sexual Dysfunction
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 176
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 176 men with unilateral inguinal hernia were randomized in two groups. Group T(n=88) were operated TEP and Group L(n:88) were operated by LH repair. Patients demografigs, perioperative findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF 36 and IIEF were filled up.
Primary purpose: TREATMENT

Brief summary: In the literature, there are several studies that compare Laparoscopic totally extraperitoneal hernia repair (TEP) with Lichtenstein hernia (LH) repair. There are no studies that compare sexual functions on men's health and quality of life. Our aim was to study the sexual functions of men, who underwent TEP or LH repair according to Health Survey Scoring Demonstration (SF36) and The International Index of Erectile Function (IIEF).

Detailed description: 176 men with unilateral inguinal hernia were randomized into two groups. Group T (n=88) underwent TEP and Group L(n:88) underwent LH repair. Patients demografigs, perioperative findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF 36 and IIEF were filled up.

Eligibility criteria: Inclusion Criteria:

* having male gender
* patients diagnosed on unilateral inguinal hernia
* patients aged between 18 and 65 years
* ASA I and II patients

Exclusion Criteria:

* having female gender
* patients diagnosed on bilateral or recurrence inguinal hernia,
* patients suffering erectile dysfunction

Primary outcomes:
measure: IIEF Scale
timeFrame: 7 to 90 days
Secondary outcomes:
measure: SF36
timeFrame: 7 to 90 days
Other outcomes:
Locations:
Study officials:
References:
citation: Kushwaha JK, Enny LE, Anand A, Sonkar AA, Kumar A, Pahwa HS. A Prospective Randomized Controlled Trial Comparing Quality of Life Following Endoscopic Totally Extraperitoneal (TEP) Versus Open Stoppa Inguinal Hernioplasty. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):257-261. doi: 10.1097/SLE.0000000000000450.
Clinical trial NCT04395352: Effectiveness of Endocuff Vision in Improving ADR
Official title: Effectiveness of EndoCuff Vision in Improving Adenoma Detection Rate in a Large Screening-Related Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 15816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing screening-related colonoscopy.

Brief summary: The goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. ECV has been shown to be efficacious in improving ADR within the context of randomized trials. However, no 'real-world' studies have been published assessing the effectiveness of ECV in non-trial settings. The primary objective of this study is to assess the effect of ECV use on ADR in a routine screening-related population.


Eligibility criteria: Inclusion Criteria:

adult patients undergoing colonoscopy.

Exclusion Criteria:

* single balloon- or double balloon-assisted colonoscopy;
* planned advanced polypectomy or endoscopic mucosal resection (EMR);
* planned endoscopic post-polypectomy or post-EMR surveillance;
* known active diverticulitis;
* known colonic stricture.

Primary outcomes:
measure: Adenoma detection rate (ADR)
timeFrame: Intra-procedural
Secondary outcomes:
measure: Adenoma detection rate among patients with positive fecal immunochemical tests
timeFrame: Intra-procedural
measure: SSADR (sessile serrated adenoma detection rate)
timeFrame: Intra-procedural
measure: CIR (cecal intubation rate)
timeFrame: Intra-procedural
measure: Procedure time
timeFrame: Intra-procedural
measure: Nurse-assessed patient comfort scores (NAPCOMs)
timeFrame: Intra-procedural
measure: Number of patients with immediate adverse events
timeFrame: Day 1
measure: Number of patients with delayed adverse events
timeFrame: Within 30 days of index procedure
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Forzani and MacPhail Colon Cancer Screening Centre (CCSC)
state: Alberta
Study officials:
References:
Clinical trial NCT02332252: Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.
Official title: Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Surgical Wound Infection
Electrocautery
Scalpel
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel.


Eligibility criteria: Inclusion Criteria:

* Elective Cesarean section, regardless of gestational age.

Exclusion Criteria:

* Skin infection in the cesarean section area.
* Emergency cesarean section.
* Presence of a maternal pathology that increases the risk of infection (immunocompromised state).

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 8 days
Secondary outcomes:
measure: Post operative pain
timeFrame: 8 days
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References: