louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00264680: Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
Official title: Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: quality of life
qolie-10
epilepsy
lamotrigine
Validation of questionnaire
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-13
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic patients treated with lamotrigine or valproic acid. Determination and assessment of the comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image perception in women treated with lamotrigine or valproic acid.


Eligibility criteria: Inclusion criteria:

* Diagnosis of epilepsy and normal neurological examination.
* Patients receiving lamotrigine or valproic acid at stable doses in monotherapy initiated 2 -4 months before.

Exclusion criteria:

* Pregnant or lactating women.
* Previous treatment with lamotrigine or valproic acid.
* Secondary epilepsy.

Primary outcomes:
measure: 1. Validity, feasibility and reliability of qolie-10 (test-retest, internal consistency) 2. Qolie-10 scores between groups 3. Body image scores between groups
Secondary outcomes:
measure: Adverse Events: nature and number between groups
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00680680: Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker
Official title: Phase 4 Study of Dual Five Alpha Reductase Inhibition Combined With Alpha Blockade in Men With Refractory Urinary Retention Secondary to BPH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Benign Prostatic Hyperplasia
Keywords: Urinary retention secondary to benign prostatic hyperplasia
Lead sponsor: Franklin D. Gaylis, MD Inc.
Sponsor class: OTHER
First posted: 2008-05-20
Enrollment: 20
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will alleviate urinary retention secondary to BPH in who have failed a voiding trial without a catheter. Following treatment with an Alpha Blocker alone.


Eligibility criteria: Inclusion Criteria:

1. Males betewen the ages of 50 and 90 years of age.Written informed consent.
2. Men with acute urinary retention attributed to bladder outlet obstruction caused by BPH, who have failed atleast 1 week trial of alpha blocker treatment.
3. PSA level equal to or greater than 1.5ng/ml and equal to or less than 15 ng/ml.

Exclusion Criteria:

1. Urinary retention attributed to a neurogenic or myogenic bladder dysfunction.
2. Use of psychotrophic medications.
3. Use of antichollinergic medications.
4. Prostate cancer.
5. Allery to five alpha reductase inhibitors.
6. Prior prostate surgery.
7. Urethral stricture.
8. Bladder calculi.
9. Invasive bladder cancer.
10. Inability to understand or agree with the requirements of the study.
11. Any investigational drug received within 30 days prior of study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director/Sponsor
name: Franklin D Gaylis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449280: Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignancies
Official title: A Drug Interaction Study of Sorafenib (BAY 43-9006 Tosylate) and Rapamycin in Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: metastatic
advanced disease
phase I
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2007-03-20
Enrollment: 34
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 goal of this study is to determine whether a significant pharmacokinetic interaction exists between rapamycin and sorafenib.

This study will also look at the toxicity of the combination of rapamycin and sorafenib and the antitumor activity of the combination in subjects with advanced cancers.


Eligibility criteria: Inclusion Criteria:

* Solid cancer for which curative measures have failed or for which there is no known superior treatment
* ECOG performance status 0-2
* Measurable or non-measurable disease
* Life expectancy of greater than 12 weeks and no anticipated need for other antineoplastic therapy in the next 4 weeks
* Age 18 years or older
* Patients must have adequate organ and marrow function as defined below:

  * ALT and AST less than or equal to 2.5 x the ULN (\< 5 x ULN for patients with liver involvement).
  * hemoglobin greater than or equal to 9 g/dL
  * absolute neutrophil count greater than or equal to 1,500/μL
  * platelets greater than or equal to 100,000/μL (greater than or equal to 35,000/μL without transfusion for patients with CLL/SLL or follicular lymphoma)
  * total bilirubin less than or equal to 1.5 x ULN
  * creatinine less than or equal to 1.5 x ULN
* Women of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
* Ability to understand and the willingness to sign a written informed consent document
* Must not have any evidence of bleeding diathesis.

Exclusion Criteria:

* Patients who have had chemotherapy or immunotherapy within 3 weeks or radiotherapy within 14 days prior to entering the study
* Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy
* Patients with uncontrolled brain metastases.
* Concurrent illness or medication exclusions
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib or rapamycin.

Primary outcomes:
measure: Pharmacokinetic interactions
timeFrame: 4 weeks
Secondary outcomes:
measure: Response Rate
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Ezra Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756180: An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
Official title: A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Parallel Group Study to Investigate the Efficacy and Safety of Omega-3-acid Ethyl Ester Over 12 Weeks in Chinese Subjects With Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertriglyceridemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 248
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: The primary objective was to investigate the effect of 12-week treatment of Omacor on fasting serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia (HTG). The secondary objectives were to investigate the safety and tolerability and effect of Omacor on lipid parameters after 12 weeks treatment.

Detailed description: This was a multicenter, randomized, double-blind, parallel-group study of twice daily treatment of Omacor or matching placebo in subjects with moderate or severe HTG.

Eligibility criteria: Inclusion Criteria:

* Baseline fasting serum TG level \> 200mg/dL and \<1000mg/dL, in subjects treated for HTG.
* If on previous statin therapy, the treatment should have been kept stable in the last 3 months before entering the study.
* Able and willing to give written informed consent.

Exclusion Criteria:

* Subjects taking fish oil capsules 8 weeks prior to inclusion in this study.
* Known allergy to the active ingredient, or fish, soya, corn or olive oild (placebos).
* Pregnant of lactating females.
* Known increased risk of hemorrhage such as recent surgery, gastrointestinal hemorrhagic disease.
* Significant hepatic disease.
* Significantly reduced renal function.
* Alcohol consumption \>30g for male and 20g for female daily.
* Concomitant use of other investigational drugs.
* Subject related to the investigator.
* Subject expected to be not compliant.

Primary outcomes:
measure: Percent change in fasting serum TG
timeFrame: Baseline to end of treatment at treatment week 12
Secondary outcomes:
measure: Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio
timeFrame: Between baseline and end of treatment week 12
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Pooi Lee Chin
role: STUDY_DIRECTOR
References:
Clinical trial NCT06226480: Machine Learning Algorithm for Predicting Postoperative Delirium in Elderly Patients After Thoracic Surgery
Official title: Development and Validation of a Prediction Model for Postoperative Delirium in Elderly Patients After Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Keywords: postoperative delirium
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 3967
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients undergoing thoracic surgeries.

Brief summary: Postoperative delirium (POD) is a common and severe complication in patients undergoing major surgery, especially in the elderly. POD has been proven to be associated with increased morbidity and mortality, institutionalization, and high healthcare costs. This retrospective cohort study aimed to use machine learning methods to develop clinically meaningful models to support clinical decision making.

Detailed description: The primary outcome was the incidence of POD within 3 days postoperatively. The patients will be randomly split into two datasets with split ratios of 80% and 20%.

Subsequently, 80% of the patients will be used for training, and 20% of the patients will be used for testing. Multiple machine learning algorithms will be used to develop POD risk prediction models. The discrimination ability of the prediction models will be assessed by calculating the area under the receiver operating characteristic curve (AUC). The calibration of the model will be evaluated using the Hosmer-Lemeshow goodness of fit test. Decision curve analysis (DCA) will be used to evaluate the net benefits for each threshold probability. The best model will be selected by comparing the performance between the models. Then the SHapley Additive exPlanations (SHAP) will be used to explain the best one.

Eligibility criteria: Inclusion Criteria:

* aged ≥ 65 years
* elective segmentectomy, lobectomy, or esophagectomy surgeries
* general anesthesia

Exclusion Criteria:

* surgery length less than 1 hour
* preoperative cognitive dysfunction
* admission to the intensive care unit
* second operation within 24 hours
* missing data for any variables

Primary outcomes:
measure: Number of participants with postoperative delirium
timeFrame: The first three postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01866280: Sleep Timing and Energy Balance
Official title: Effect of Sleep Timing, Independent of Duration, on Food Intake and Metabolic Control of Energy Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Meals
Keywords: Sleep
Sleep duration
Meals
Food intake
Obesity
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults.

This study will be a 4-phase, randomized controlled study of 5 days each in which participants will undergo 2 phases of late sleep times that differ in meal timing (normal or late) and 2 phases of normal sleep times that differ in meal timing (normal or late).

The Aims and Hypotheses of this study are:

Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response to altered sleep and meal timing.

* Hypothesis 1: There will be an interaction between sleep and meal time on glucose, insulin, and glucose and insulin area under the curve after the glucose tolerance test such that the late sleep/late meal will result in the worst metabolic profile, normal sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal will result in the best metabolic profile.
* Hypothesis 2: There will be an interaction between sleep and meal time on leptin and ghrelin concentrations such that the late sleep/late meal timing phase will result in low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal timing will result in high leptin/low ghrelin.

Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal timing.

• Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase compared to normal sleep timing.


Eligibility criteria: Inclusion Criteria:

* Body mass index 22-25
* Normal scores on sleep questionnaires (PSQI, ESS, Berlin, SDIQ)
* Normal score on Beck Depression Inventory
* Intermediate chronotype on Composite Scale of Morningness/Eveningness

Exclusion Criteria:

* Neurological, medical, or psychiatric disorders
* Eating disorders
* Diabetes
* Sleep disorders
* Travel across time zones
* History of drug/alcohol abuse
* Caffeine intake \>300 mg/d
* Excessive daytime sleepiness
* Pregnancy or within 1 y post-partum

Primary outcomes:
measure: Food intake
timeFrame: Single day
measure: Oral Glucose Tolerance
timeFrame: 2 hours
measure: Meal tolerance test
timeFrame: 3 hours
Secondary outcomes:
measure: Hormonal profile
timeFrame: 24 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's/Roosevelt Hospital
state: New York
Study officials:
References:
Clinical trial NCT06138080: Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
Official title: Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: VUR - Vesicoureteric Reflux
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine the applicability of contrast enhanced voiding ultrasonography in diagnosing vesicoureteral reflux (VUR) in pediatric patients compared to direct isotope cystography. The aim of the study is to find a modality allowing the accurate diagnosis of VUR and the classification of the degree of VUR with the least possible harm from the examinations.

The investigators recruit 100 under 6 years old patients who have had at least 2 culture positive urinary tract infections. Exluding criteria are abnormal bladder function and posterior uretral valves. The investigators perform direct isotope cystography and contrast enhanced voiding urosonography during the same day to diagnose and grade VUR. The investigators use standardized volume and speed of bladder filling. The examinations are done by a radiologist and an isotope specialist and they are blinded to the result of the other examination.


Eligibility criteria: Inclusion Criteria:

* under 6 years old patients who have had at least 2 culture positive urinary tract infections

Exclusion Criteria:

* abnormal bladder function
* posterior uretral valves

Primary outcomes:
measure: Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux
timeFrame: 1 day
Secondary outcomes:
measure: Incidence and severity of adverse effects associated with CEVUS
timeFrame: 1 year
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University hospital
Study officials:
References:
Clinical trial NCT03708380: Diabetes Prevention for Black Men
Official title: Using a Geographically Targeted and Mixed Methods Approach to Improve Glycemic Control Among Black Men Identified as Having Previously Undiagnosed Diabetes and Prediabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Geographic analyses of diabetes burden have found that poor glycemic control, high rates of diabetes-related hospital utilization, and a high prevalence of microvascular diabetic complications all cluster in the same neighborhoods.This proposed study seeks to identify Black barbers with undiagnosed diabetes or prediabetes using point-of-care HbA1c testing, perform qualitative interviews to identify health behaviors that may explain poor sugar control, and develop a workplace-based food intervention to promote primary prevention and test its effect on sugar control in these individuals.


Eligibility criteria: Inclusion Criteria:

* Black or African American men who work as barbers at Black-owned barbershops
* Barbershop clients.
* Workplace in neighborhood geographically identified as having higher diabetes burden
* No prior history of clinical diagnosis of diabetes
* Identified on initial and second point-of-care testing to have an HbA1c of 5.7 or greater

Exclusion Criteria:

* Individuals with a history of blood loss or blood disorder that would lead to incorrect results on point-of care HbA1c testing
* Individuals with a history of food allergies that requires specific dietary restrictions
* Individuals who are not English speaking
* Individuals who have a significant cognitive impairment that will be a barrier to communication, valid consent and participation

Primary outcomes:
measure: Adherence to the intervention during the initial 60-day period when lunches are provided at no cost
timeFrame: 60 days
measure: Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own
timeFrame: Until the end of the two year study period
Secondary outcomes:
measure: Photographic food and beverage diaries
timeFrame: Baseline
measure: First Point-of-care Hemoglobin A1c (HbA1c) test
timeFrame: Baseline
measure: Second Point-of-care HbA1C test
timeFrame: Baseline (3-6 months after first test)
measure: Third Point-of-care HbA1C test
timeFrame: Post treatment (3 months after the intervention)
measure: Fourth Point-of-Care HbA1c Test
timeFrame: Post-Treatment (6 to 12 months after the intervention)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02011880: Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer
Official title: Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Breast Cancer
Bone Metastasis
Keywords: breast cancer
bone metastasis
traditional Chinese medicine(TCM)
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-12-13
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this clinical research study is to learn if the clinical effects of combined Chinese herbal medicine with endocrine therapy is better than endocrine therapy alone in improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

Detailed description: OBJECTIVES:

* Evaluate the effect of the Chinese herbal medicine on relieving the bone pain for patients with breast cancer bone metastasis.
* Evaluate the effect of the Chinese herbal medicine on improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

OUTLINE: This is a randomized,multicentric, placebo-controlled, double-blind study. Patients are dynamic randomized to one of two treatment arms.

* Arm I:Patients receive traditional Chinese medicine(trial drugs) and endocrine therapy for 3 months.
* Arm II:Patients receive placebo and endocrine therapy for 3 months. All patients will be followed up for another 3 months with the trial drugs and endocrine therapy.

According to the sample size estimate:There are 296 patients (148 per treatment arm)will be collected in this trial.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed breast cancer and hormone receptor positive.
* Bone metastasis and have a measurable foci.
* TCM syndrome type is deficiency of both vital energy and Yin ;maladjustment of ChongRen with deficiency Yang syndrome.
* The Karnofsky score ≥60.
* VAS score ≥3.
* Expected survival at least 6 months or greater.
* Age between 20 to 70(include 20 and 70).
* The function of cardiovascular,hepar,renal and hematopoieses is relatively normal.

Exclusion Criteria:

* Women during the pregnancy or breast feeding.
* With a cardiovascular,hepar,renal,hematopoieses or other serious complications.
* Be allergic to the trial drugs.
* Participating in other trials.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: