louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01456754: Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
Official title: Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Keywords: Insulin Metabolism
Glucose Metabolism
Substrate Partitioning
Muscle Biopsies
Feeding Frequency
Insulin
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Nederlandse Zuivel Organisatie
First posted: 2011-10-21
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.


Eligibility criteria: Inclusion Criteria:

* BMI: 20-35 kg/m2
* Gender: Male
* Age: subjects has to be older than 18 and younger than 70 years old
* Impaired Glucose Tolerant (IGT) = plasma glucose, two hours after consuming 75g glucose, appears to be superior to 7.8mmol/l (normal level) but remains inferior to 11.1mmol/l (diabetes level) and fasting plasma glucose is less than 7.0mmol/l.
* Caucasian

Exclusion Criteria:

1. Lactose intolerant
2. Diabetes Mellitus
3. Cardiovascular diseases
4. Stomach and intestinal diseases
5. Normal glucose levels after 2 hours
6. Anticoagulants
7. Medication that has a effect on energy and glucose homeostasis and absorption of foods
8. Conditions or situations when subjects can't lose 500 ml blood

Primary outcomes:
measure: Glucose metabolism
timeFrame: 24 hour profile
measure: Insulin metabolism
timeFrame: 24 hour profile
Secondary outcomes:
measure: Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets
timeFrame: 24 hour profiles
measure: Metabolic markers (FFA and TG metabolism)
timeFrame: 24 hour profile
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University of Maastricht
Study officials:
affiliation: Maastricht University
name: Wim Saris, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06082154: A Prognostic Model Based on POCUS at ICU Admission in Critically Ill Patients With Sepsis
Official title: A Prognostic Model Based on POCUS at ICU Admission in Critically Ill Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 175
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who are diagnosed as having sepsis as per Sepsis 3 definition

Brief summary: Sepsis is responsible for one in three patient deaths. Understanding the severity of the disease, directing medications, prognosticating, and communicating with family members depend on the ability to predict outcomes in a patient presenting with sepsis in the ICU. The outcome of mortality reflects the caliber of ICU treatment. This is a prospective observational study that will include all patients diagnosed with sepsis for point-of-care ultrasonography within 24 hours of admission to the ICU from April 26, 2023, to March 30, 2024, and create a model that will predict 28 day outcome in these patients.


Eligibility criteria: Inclusion Criteria:

* Age \>=16 yrs within 24 hour of ICU admission diagnosed as Sepsis as per Sepsis 3

Exclusion Criteria:

* USG cannot be done within 24 hour of admission to icu If USG cannot be done for 2 parameters Who do not give consent Withdrawal of active life support Do not intubate(DNI) or do not resuscitate(DNR) order at admission

Primary outcomes:
measure: 28 day status alive or dead
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Ashmita Paudel
state: Bagmati
Study officials:
References:
Clinical trial NCT04765254: COVID-19 Infection in Diabetic Patients
Official title: Clinical Features of Diabetic Patients With COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Diabete Type 2
Non Diabetic Patients
Chest CT Scan
Keywords: COVID-19
prognosis
mortality rate
Diabetes Mellitus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients infected with COVID-19 either diabetic or have no comorbidities, inpatients

Brief summary: It was observed during the last period of COVID-19 pandemic that diabetic patients had a worse prognosis and more deteriorated clinical features than other patients

Detailed description: Diabetic patients infected with SAR-COV-19 were reported to have worse prognosis and faster deterioration in addition to higher rate for ICU admission when compared to other infected patients. In this study authors aim to investigate the certain cause for their case deterioration to be modified for better prognosis

Eligibility criteria: Inclusion Criteria:

Patients infected with COVID-19 male or female 30 years old or more inpatients

Exclusion Criteria:

* have othe comorbidities other than type 2 diabetes mellitus pregnant women below 30 years old

Primary outcomes:
measure: Investigation of bad prognosis cause for covid-19 diabetic patients
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University teaching hospitals
state: Kasr Al Ainy
Study officials:
References:
Clinical trial NCT02706054: Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam
Official title: Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam: a Randomized, Double Blind, Placebo Controlled Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo control, cross-over study tested the hypothesis that periradicular injections of Meloxicam would reduce recent onset low back pain and improve physical activity compared to saline injection at 3 months follow-up evaluation

Detailed description: In the present study we use a well-known non steroidal anti-inflammatory drug, meloxicam, in a novel way, an IM administration near a nerve root.

Eligibility criteria: Inclusion Criteria:

* low back pain from 6 months or less
* older than 18 years

Exclusion Criteria:

* not able to understand and sign the written informed consent

Primary outcomes:
measure: Change from baseline NRS pain scale score at different consecutive follow up assessments
timeFrame: 5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days
Secondary outcomes:
measure: Change from baseline level of physical activities and life quality at different consecutive follow up yes/no questionnaire
timeFrame: 5 minutes, 1, 6,12 and 24 hours, 1, 5, 15, 30 and 90 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: battista borghi, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borghi B, Aurini L, White PF, Mordenti A, Lolli F, Borghi R, Martignani M, Greggi T. Long-lasting beneficial effects of periradicular injection of meloxicam for treating chronic low back pain and sciatica. Minerva Anestesiol. 2013 Apr;79(4):370-8. Epub 2013 Jan 10.
citation: Aurini L, Borghi B, White PF, TOGNu A, Rossi B, Fini G, Fusco P, Mosca M, Borghi R. Treatment of chronic cervicobrachial pain with periradicular injection of meloxicam. Minerva Anestesiol. 2016 Apr;82(4):411-8. Epub 2015 Sep 3.
Clinical trial NCT02457754: Physical Fitness and Bone Structure Evaluation in Preschool Children
Official title: Physical Fitness and Bone Structure Evaluation in Preschool Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child, Preschool
Bone Structure
Physical Fitness
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 225
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy 3 to 5 year-old children

Brief summary: Several studies have shown a high association between physical fitness and present and future health. Two of the main epidemics of the industrialized world are obesity and osteoporosis, diseases that could be prevented with early interventions from childhood. Both, physical activity and physical fitness have shown an association with these diseases, but tools for assessing them in early ages are still in development. Moreover, there is a lack of physical fitness reference values in preschool children and the relation of pathologies with physical fitness in these ages is still to be demonstrated. Therefore, through a simple and precise methodology displayed in the school and adapted for the younger we intend to: Provide a combination of safe and precise field tests to evaluate health related physical fitness in preschool children. Analyze body composition, risk of overweight, obesity and low mineral density and their relation with physical activity. The evaluation of these health-related physical fitness variables in early ages is of great interest to clinic and public health.


Eligibility criteria: Inclusion Criteria:

* Healthy
* 3 to 5 years old

Exclusion Criteria:

* Unhealthy
* Taking drugs affecting bone

Primary outcomes:
measure: Assessment of physical fitness in preschool children
timeFrame: 4 months evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad de Zaragoza
Study officials:
affiliation: Universidad de Zaragoza
name: German Vicente-Rodríguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01620554: Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
Official title: Minimum Effective Dose-Finding Study of BF2.649, in Patients With Moderate to Severe OSA, Experiencing EDS Despite Regular Use of nCPAP, and Patients Having Refused This Therapy - Randomized, Double Blind Study With BF2.649 or Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnoea
Excessive Daytime Sleepiness
Keywords: Sleep disorder
Obstructive Sleep Apnoea
Excessive Daytime Sleepiness
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).

Detailed description: Obstructive sleep apnea (OSA) is a relatively common condition and is estimated to affect 2 to 4% of middle-aged adults

The study medication BF2.649 tested here is a novel, highly potent, selective, orally active inverse agonist at the histamine H3 receptor, therefore strengthens histaminergic transmission in the brain and increases wakefulness EDS is characterized by daytime somnolence and sudden sleep episodes. This problem has several consequences, e.g., an impairment of quality of life, an interference with activities of daily living and other handicaps in the management of social and family affairs.

The primary endpoint of this study will be measured by the change in the well-validated Epworth sleepiness scale (ESS). The ESS is a simple self-administered 8-item questionnaire. The outcome is to get an impression about the level of the daytime sleepiness in several real-life situations.

In this study, each patient will be treated during 2 weeks, and randomly assigned to one the 5 arms (BF2.649 at one of the 4 possible dosages or placebo).

The patient will then attend a end-of-treatment visit, in order to assess the particularly the ESS score.

Eligibility criteria: Main inclusion Criteria:

* Patient with OSA (treated or not with nCPAP) and still complaining of EDS
* Epworth Sleepiness Scale score \> or = to 11

Main exclusion Criteria:

* Patient suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders, but without OSA

Primary outcomes:
measure: Change in Epworth Sleepiness Scale scores (ESS)
timeFrame: change of ESS at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
Study officials:
affiliation: Bioprojet
name: Evelyne De Paillette, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02482454: Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
Official title: Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Cholangiocarcinoma
Keywords: radiofrequency ablation
cytokine-induced killer cells
cholangiocarcinoma
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cholangiocarcinoma.

Detailed description: The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed cholangiocarcinoma
* Primary lesions (cholangiocarcinoma) are not resected
* Serum bilirubin level of 2.0 mg/dl or less.
* Performance status of 0 or 1.
* Expected survival of 1 year or more.
* Informed consent from the patient.

Exclusion Criteria:

* With extrahepatic metastases
* With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
Study officials:
affiliation: The First People's Hospital of Changzhou
name: Changping Wu, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01837654: Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity
Official title: Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Detrusor
Keywords: Detrusor Overactivity
Plantarflexion
Urgency
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-04-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether plantarflexion has an effect on the degree of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in patients with detrusor overactivity (DO).

Detailed description: Patients with urodynamic DO will be included in this study. During urodynamics, the mean peak detrusor pressures of each contraction will be documented and compared. At the beginning of the 2nd or 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. Following each wave, patients will be asked to grade the severity of the urgency by a visual analogue scale

Eligibility criteria: Inclusion Criteria:

All patients with urodynamic detrusor overactivity

Exclusion Criteria:

Inability to perform plantarflexion due to mental or physical disability

Primary outcomes:
measure: Mean Peak Detrusor Pressures
timeFrame: through test completion, an average of 10 minutes
Secondary outcomes:
measure: Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).
timeFrame: through test completion, an average of 10 minutes
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Assaf Harofe Medical Center
name: Kobi Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06828354: A Study of SHR-A1811 in Subjects With Ovarian Cancer
Official title: An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 300
Sex: FEMALE
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 is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.


Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily joined the study and signed the Informed consent forms (ICF).
2. Measurable disease, as defined by RECIST v1.1.
3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.

Exclusion Criteria:

1. Symptomatic, untreated or active central nervous system metastases.
2. Have uncontrolled or severe cardiovascular disease.
3. With any active autoimmune disease or history of autoimmune disease.
4. Patients with active hepatitis B or hepatitis C.
5. Severe infections prior to initiation of study treatment.
6. Patients with active tuberculosis.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: From day 1 to 10 months.
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: From day 1 to 12 months.
measure: Disease control rate (DCR)
timeFrame: From day 1 to 12 months.
measure: Duration of response (DOR)
timeFrame: From day 1 to 12 months.
measure: Overall survival (OS)
timeFrame: From day 1 to 12 months.
measure: Response rate (RR)
timeFrame: From day 1 to 12 months.
measure: Adverse events (AEs)
timeFrame: From day 1 to 40 days after the last dose.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT06119477: Three Techniques in Bioceramic Apexification for Necrotic Immature Incisors
Official title: Comparison of Three Techniques in Bioceramic Apexification Procedure for Necrotic Immature Incisors: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immature Teeth
Periapical Lesion
Keywords: post-operative pain
periapical lesion healing
bioceramic apexification
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial is to find the most effective Bioceramic-based apexification procedures in children with immature necrotic maxillary incisors. The main questions they aims to answer are:

* What is the best Bioceramic apexification technique regarding the post-operative pain and the periapical healing ?
* What is the best Bioceramic apexification technique regarding the bioceramics extrusion and the required time ? Participants will under gone Bioceramic apexification procedures which root canal preparing, disinfecting, filling, and restoring. Then, the patient will asked to come to follow-up appointments for clinical and radiological evaluations If there is a comparison group: Researchers will compare Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer, and Combination of Bioceramic putty and sealer technique to find the best effective technique.


Eligibility criteria: Inclusion Criteria:

* Patients with one or more maxillary incisors with an open apex root (defined as root which root canal size equal or larger than #80 K-file) and presented with pulp necrosis and radiographic evidence of chronic apical periodontitis and periapical radiolucency greater than 3 mm.

Exclusion Criteria:

* Children with systemic diseases that compromised their general immune status.
* Uncooperative (definitely negative on the Frankl's behavioral scale).
* unrestorable incisors.

Primary outcomes:
measure: Clinical evaluation
timeFrame: 12 months
measure: Radiographical assessment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: Damascus University
name: Osama Aljabban, Proffesor
role: STUDY_DIRECTOR
References:
citation: Tolibah YA, Kouchaji C, Lazkani T, Ahmad IA, Baghdadi ZD. Comparison of MTA versus Biodentine in Apexification Procedure for Nonvital Immature First Permanent Molars: A Randomized Clinical Trial. Children (Basel). 2022 Mar 14;9(3):410. doi: 10.3390/children9030410.