louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02248454: Insulin Bolus Required for High Fat Foods in Type 1 Diabetes
Official title: Evaluation of Insulin Bolus for High Fat Meals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2014-09-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.

Subjects will have several admissions during which the investigators will apply an iterative dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The investigators hypothesize that the incremental insulin dose required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (U/kg).

Detailed description: Subjects for this study will be adults with type 1 diabetes who use an insulin pump for diabetes self-management.

Subjects will be admitted to the clinical research center in the morning in the fasting state. Subjects will have several admissions. During the initial two admissions, subjects will receive either pizza-low fat or pizza-high fat, covered with insulin doses calculated from their usual insulin-to-carbohydrate ratio. Study subjects in whom the bolus did not provide adequate insulin coverage for pizza-high fat will then undergo an additional 1-5 admissions during which they will receive the pizza-high fat meal with progressively increasing insulin doses until ≥ 90% of all postprandial glucose values are within the target range 80-180 mg/dL.

Eligibility criteria: Inclusion Criteria:

* Adult patients (aged 18-75 years) with type 1 diabetes \> 3 years, on insulin pump therapy.

Exclusion Criteria:

* History or symptoms suggestive of gastroparesis or gastric dysmotility; History of celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion; Eating disorder; Diet allergies; Special diet restrictions, such as vegan; Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan); High-titre insulin autoantibodies with delayed insulin kinetics; Women who are breast feeding, pregnant, or wanting to become pregnant.

Primary outcomes:
measure: Predictors of fat "sensitivity"
timeFrame: 0-360 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Joslin Diabetes Center
name: Howard Wolpert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bell KJ, Toschi E, Steil GM, Wolpert HA. Optimized Mealtime Insulin Dosing for Fat and Protein in Type 1 Diabetes: Application of a Model-Based Approach to Derive Insulin Doses for Open-Loop Diabetes Management. Diabetes Care. 2016 Sep;39(9):1631-4. doi: 10.2337/dc15-2855. Epub 2016 Jul 7.
Clinical trial NCT00386854: Metabolic Study of Concentric and Eccentric Muscle Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Metabolism
Insulin Resistance
Inflammation
Keywords: exercise
lipid metabolism
lipoproteins
insulin resistance
inflammation
Lead sponsor: Vorarlberg Institute for Vascular Investigation and Treatment
Sponsor class: OTHER
First posted: 2006-10-12
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: The purpose of this study is to evaluate the metabolic and anti-inflammatory effects of eccentric endurance exercise and to compare them with those of concentric exercise in healthy sedentary individuals.

Detailed description: Physical exercise decreases the risk of obesity, diabetes mellitus, and cardiovascular disease. Skeletal muscle can be exercised by two ways: Concentric contraction is defined as active shortening of muscles, e.g. by stepping upwards, whereas eccentric muscle contraction is defined as active resistance to stretching, e.g. by stepping downwards. Although the effects of exercise (i.e. the combination of concentric and eccentric muscle contraction) on metabolic parameters have been extensively investigated, there are no data on the specific metabolic effects of concentric versus those of eccentric muscle work in humans.

Comparison(s): Metabolic and anti-inflammatory effects of eccentric endurance exercise (i.e. stepping upwards), compared to metabolic and anti-inflammatory effects of concentric exercise (i.e. stepping downwards).

Eligibility criteria: Inclusion Criteria:

* healthy men and women
* age over 30 years

Exclusion Criteria:

* previous systematic endurance training (≥3 times per week ≥30 min)
* body mass index \>30 kg/m2
* heavy smoking (\>20 cigarettes per day)
* regular alcohol consumption \>60g per day
* established musculoskeletal disease
* history of cardiovascular disease
* diabetes mellitus
* unwillingness to stay in the area for the whole study period

Primary outcomes:
measure: Metabolic and anti-inflammatory effects induced by eccentric muscle exercise.
Secondary outcomes:
measure: Metabolic and anti-inflammatory effects induced by concentric muscle exercise.
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Vorarlberg Institute of Vascular Investigation and Treatment
state: Vorarlberg
Study officials:
affiliation: Vorarlberg Institut of Vascular Investigation and Treatment, Academic Teaching Hospital, Austria
name: Heinz Drexel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drexel H, Mader A, Saely CH, Tautermann G, Dopheide JF, Vonbank A. Downhill hiking improves low-grade inflammation, triglycerides, body weight and glucose tolerance. Sci Rep. 2021 Jul 15;11(1):14503. doi: 10.1038/s41598-021-93879-1.
Clinical trial NCT06346054: Molecular Assessment for Gastro-Esophageal Cancer
Official title: Molecular Assessment for Gastro-Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Gastric Cancer
Barrett Esophagus
Keywords: Oncometabolites
Early-stage cancer
Diagnostic testing
Screening
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with gastro-esophageal cancer, participants with Barrett's esophagus and Healthy controls will be monitored in parallel to identify oncometabolic biomarkers related to cancer
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer.

The main questions this study aims to answer:

Are oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups.

Participants will provide a breath and blood sample during their routine standard of care visits.


Eligibility criteria: Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any breath or blood analysis
2. \>18 years old
3. Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV
4. Voluntary healthy controls

Exclusion Criteria:

1. \<18 years old
2. Patient has history of:

   1. Active other cancer than gastro-esophageal cancer
   2. Prior cancer treated \<3 years ago
   3. Hepatic dysfunction/liver failure (MELT \>7)
3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study plan.
4. Insufficient/unreliable quality of breath (e.g., breath flow) or plasma sample (e.g., haemolytic sample)
5. Incarcerated individuals

Primary outcomes:
measure: Identification of the concentrations of oncometabolites
timeFrame: year 1-2
Secondary outcomes:
measure: Assessment of incidence of early-stage cancer
timeFrame: year 2-5
measure: Assessment of incidence of therapy response
timeFrame: year 2-5
measure: Assessment of percentage change of therapy response
timeFrame: year 2-5
measure: Assessment of incidence of recurrence
timeFrame: year 2-5
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Stijn Vanstraelen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Philippe Nafteux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04368754: Validity and Reliability the Turkish Version of the Oxford Participation and Activities Questionnaire in Older People
Official title: Validity and Reliability the Turkish Version of the Oxford Participation and Activities Questionnaire (Ox-PAQ) in Older People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Aging
Keywords: Aged
Community Participation
Health
Physical Activity
Questionnaire
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 230
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older people (65 and older years)

Brief summary: To evaluate the validity and reliability of Turkish version of the Oxford Participation and Activities Questionnaire (Ox-PAQ) for Turkish older population. Following the translation protocol of the Ox-PAQ, Short Form-12, Katz Index of Independence in Activities of Daily Living Scale, The Five Times Sit to Stand Test were administered to 230 older people. End of this study, occupational therapists, physiotherapists can use the it to assess activity and participation level of older people living in community


Eligibility criteria: Inclusion Criteria:

* Aged 65 years or older
* Mini Mental State Examination score greater than 24,
* Able to mobilize independently.

Exclusion Criteria:

* Severe vision and hearing loss
* Having an orthopaedic, vestibular, neurological or mental problem
* Failure to cooperation
* Presence of an acute disease during recovery.

Primary outcomes:
measure: Ox-PAQ
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
Study officials:
affiliation: Suleyman Demirel University, Department of Physiotherapy and Rehabilitation
name: MERVE KARAPINAR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karapinar M, Baskurt F, Baskurt Z, Gunal A, Kockar MC. Reliability and Validity of the Turkish Version of the Oxford Participation and Activities Questionnaire in Older People. Ann Geriatr Med Res. 2020 Dec;24(4):282-289. doi: 10.4235/agmr.20.0074. Epub 2020 Dec 24.
Clinical trial NCT05801354: Turmeric Gel as Alternative Non-vital Pulpotomy Medicament in Primary Teeth
Official title: Turmeric Gel as Alternative Non-Vital Pulpotomy Medicament in Primary Teeth-A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Vital Tooth
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
Collaborators: name: Lahore General Hospital
First posted: 2023-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Turmeric gel= interventional drug Formocresol= Control drug (standard drug)
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled clinical trial is to use Turmeric gel as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Turmeric gel compared with Formocresol, when used as non-vital Pulpotomy medicaments.

Detailed description: It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Turmeric gel). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).

Eligibility criteria: Inclusion Criteria:

1. Cooperation of patients and consent of parents.
2. Patients with ASA classification I and II (mild to moderate systemic disease).
3. Non-traumatic extensively carious hence restorable primary molars.
4. No history of antibiotic use for 2 weeks.
5. Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/ redness/ swelling, and/or slight mobility-grade I.

Exclusion Criteria:

1. History of allergy to anesthetics and latex.
2. Radiographic evidence of pulpal floor opening into the furcation area.
3. More than half of the roots resorbed.

Primary outcomes:
measure: Antibacterial effect
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: de' Montmorency College of Dentistry
state: Punjab
Study officials:
affiliation: Associate Professor of Operative Dentistry (Supervisor)
name: Shazia Naz, BDS, MDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06751654: Can Total Mechanical Power Be a Determinant of Weaning Failure in Chronic Obstructive Pulmonary Disease (COPD)?
Official title: Can Total Mechanical Power Be a Determinant of Weaning Failure in Chronic Obstructive Pulmonary Disease (COPD)?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
ARDS (Acute Respiratory Distress Syndrome)
Mechanical Power
Pneumonia
Weaning Failure
Keywords: Mechanical Power
COPD
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Masih Daneshvari Hospital
First posted: 2024-12-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated patients with COPD which has been diagnosed Pneumonia or ARDS and have admission to icu and stayed for more than 5 years.

Brief summary: A Comparison of Ventilator Parameters (TV, DP, Total Mechanical Power, etc.) Between Successfully and unsuccessfully Weaned Patients with COPD Undergoing Mechanical Ventilation Due to Respiratory Failure, and Diagnosed with Pneumonia or ARDS in the Intensive Care Unit."

Detailed description: The objective of this study is to investigate which mechanical ventilation parameters and clinical findings influence weaning success by comparing successful and unsuccessful weaning patient groups among patients diagnosed with COPD who were intubated and monitored for more than five days in the intensive care unit. The findings of this study may contribute to the development of future treatment protocols and criteria for evaluating the weaning process.

This study is planned to be conducted in two centers: Bakırköy Dr. Sadi Konuk Training and Research Hospital in Istanbul and Shahid Beheshti University of Medical Sciences, Masih Daneshvari Hospital in Tehran. This multicenter study aims to facilitate the comparison of data obtained under different geographical and clinical conditions, thereby enabling a broader analysis of factors influencing the weaning process across a larger patient population.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and older
* COPD-diagnosed patients who have been intubated and stayed in the ICU for more than 5 days

Exclusion Criteria:

* Patients without electronic medical records
* Patients under 18 years of age
* Patients diagnosed with pulmonary malignancy
* Patients who stayed in the ICU for less than 5 days
* Patients monitored in the ICU without intubation

Primary outcomes:
measure: Successful Weaning
timeFrame: 48 hours
Secondary outcomes:
measure: Mechanical Ventilator Parameters
timeFrame: 48 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Research and Training Hospital
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: Zafer Cukurova, M.D
role: STUDY_CHAIR
affiliation: Masih Daneshvari Hospital
name: Seyed Mohammadreza Hashemian, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06458751: Electrophysiological Study of Berrettini Anastomosis
Official title: Electrophysiological Study of Berrettini Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electrophysiologic Study
Hand Anastomosis
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The common opinion that sensory supply of digit 5 (D5) and medial half of digit 4 (D4) of the hand is by ulnar nerve, while the lateral half of D4 and the remaining digits is by median nerve is an oversimplification of a complex topic. Indeed, the literature demonstrated that both the median and ulnar nerves display a number of deviations to the traditionally taught branching patterns.

The aim of our study was to investigate the physiological role of median and ulnar nerves in the sensory supply of D4.


Eligibility criteria: Inclusion Criteria:

* age 24-60 years
* male and female
* under informed consent
* no history of previous neuromuscular disease and no abnormalities on neurological examination

Exclusion Criteria:

-

Primary outcomes:
measure: analysis of the sensory potential (UV amplitude in MSEC) recorded on both sides of the IV finger of the hand by stimulation of the median nerve and the ulnar one
timeFrame: immediately after the procedure
measure: analysis of the sensory potential ( latency in MSEC) recorded on both sides of the IV finger of the hand by stimulation of the median nerve and the ulnar one
timeFrame: immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT05227651: AK104 in Neoadjuvant Treatment of Cervical Cancer
Official title: Phase II Study on AK104 in Neoadjuvant Treatment of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II open label study to evaluate the safety and efficacy of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) in neoadjuvant treatment of cervical cancer.


Eligibility criteria: Inclusion Criteria:

1. Age≥18 \& ≤75.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Histologically or cytologically confirmed diagnosis of primary cervical squamous cell carcinoma.
4. According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed in stage IB2-IIA2.
5. Has not received any treatment before.
6. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
7. Has adequate organ function.

Exclusion Criteria:

1. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
2. Active Hepatitis B or Hepatitis C.
3. History of severe bleeding tendency or coagulation disorder.
4. Undergone major surgery within 30 days prior to the first dose of study treatment.
5. Pregnant or lactating female patients.
6. Drug or alcohol abuse.
7. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 6 mouths
measure: Major pathological response (MPR) rate
timeFrame: within 14 working days after operation
Secondary outcomes:
measure: R0 resection rate
timeFrame: within 14 working days after operation
measure: Pathological Complete Response (pCR) rate
timeFrame: within 14 working days after operation
measure: Objective response rates (ORR)
timeFrame: 4-6 weeks after the first cycle of neoadjuvant treatment
Other outcomes:
Locations:
city: Hanzhong
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: