louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00682942: How to Predict Lung Recruitment at the Bedside in Patients Affected by Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)
Official title: How to Predict Lung Recruitment at the Bedside in Patients Affected by Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients affected by acute lung injury/acute respiratory distress syndrome who are mechanically ventilated

Brief summary: The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis.

Detailed description: The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis:

* stress index technique
* peep test
* recruitment technique used in the EXPRESS study
* recruitment technique used in the LOV study

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome
* Mechanical ventilation

Exclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease
* Clinical diagnosis of pneumothorax
* Haemodynamic instability

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital
name: Davide Chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03363542: The Effects of Increased Fiber Diet Consumption on Outcomes of Subjects With Visceral Obesity
Official title: The Effects of Increased Fruits and Vegetables and/or Whole Grain Food Consumption on Cardio Metabolic Risk Factors of Subjects With Visceral Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Visceral Obesity
Lead sponsor: United Arab Emirates University
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: diet rich in fruits, vegetables and/or whole-grain fiber
Primary purpose: OTHER

Brief summary: The investigators propose to undertake a controlled dietary intervention study in UAE subjects with visceral obesity to examine the feasibility of a diet rich in fruits, vegetables and/or whole-grain fiber in the UAE population. The research will also investigate the longer-term influence of increased fruits, vegetables and fiber consumption on health and its capacity to sustain lifestyle change.

Detailed description: The United Arab Emirates (UAE) has one of the highest prevalence of obesity related diabetes mellitus in the World \[3\]. Visceral (abdominal) obesity is particularly common and more closely related to morbidity in the UAE. The investigators propose to undertake a controlled dietary intervention study in UAE subjects with visceral obesity, the aims of which are: (i) To examine the feasibility of a diet rich in fruits, vegetables and/or whole-grain fiber in the UAE population (ii) To examine the effects of increased fruits, vegetables and/or whole-grain fiber consumption on cardio metabolic risk factors (iii) To investigate the longer-term influence of increased fruits, vegetables and fiber consumption on health and its capacity to sustain lifestyle change. The proposed study will provide the scientific rationale and the methodology for improving the diet and promote healthy eating in the UAE population.

Eligibility criteria: Inclusion Criteria:

* Individuals with visceral obesity (WC=\>88 cm for women and =\>92 cm for men).

Exclusion Criteria:

* Individuals with severe chronic clinical or psychiatric disease, 2) Participating in other intervention trials, have a special diet or taking supplements. Consent All volunteers will be required to provide informed written consent

Primary outcomes:
measure: Waist circumference in cm
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ain
country: United Arab Emirates
facility: United Arab Emirates University
state: Abu Dhabi
Study officials:
affiliation: United Arab Emirates University
name: Salah Gariballa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01182142: Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients
Official title: Phase II Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Renal Cell Carcinoma
Lead sponsor: Kidney Cancer Research Bureau
Sponsor class: OTHER
First posted: 2010-08-16
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed non-clear cell renal cell carcinoma
* confirmed metastatic sites
* no chemotherapy in history

Exclusion Criteria:

* metastases in CNS
* previous targeted therapy
* other tumor

Primary outcomes:
measure: Overall response rate
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival Progression-free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Natalia Petenko
Study officials:
affiliation: N.N. Blokhin Russian Cancer Research Center
name: Lev Demidov, MD, D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsimafeyeu I, Demidov L, Kharkevich G, Petenko N, Galchenko V, Sinelnikov I, Naidzionak U. Phase II, multicenter, uncontrolled trial of single-agent capecitabine in patients with non-clear cell metastatic renal cell carcinoma. Am J Clin Oncol. 2012 Jun;35(3):251-4. doi: 10.1097/COC.0b013e31820dbc17.
Clinical trial NCT06037642: All Children in Focus (ABC) 0-2 Years: A Pilot Study
Official title: All Children in Focus (ABC) 0-2 Years: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Parenting
Keywords: Parenting support
Lead sponsor: Ersta Sköndal University College
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare parents tools to handle challenges and strengths as parents. The main questions it aims to answer are:

* Do participating parents feel more confident than non partipating parents?
* Does the program have positive effects on parenting practices, parents´ well-being, and social support?
* Is the programme more effective for some groups of parents ( e.g., gender, socioeconomis status)

Participating parents will attend four 1-hour, manual based sessions followed by a 30-minutes optional coffe break. In addition parents will be asked to do homework assignments between the sessions.

Researchers will compare the intervention group with an equally sized control group that will receive the program later the same year.


Eligibility criteria: Inclusion Criteria:

Parents to children aged 0-2 years

Exclusion Criteria:

Non fluent in Swedish language

Primary outcomes:
measure: Parents´self efficacy
timeFrame: Four weeks
measure: Parenting practices and parent child relationship
timeFrame: Four weeks
measure: Parents´involvement and warmth
timeFrame: Four weeks
measure: Parents´ well-being
timeFrame: Four weeks
measure: Parents´ social network
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: PLUS
Study officials:
affiliation: Ersta Sköndal University College
name: Maria Eriksson, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT00731042: A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
Official title: A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Skin health
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2008-08-08
Enrollment: 33
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Female age 25 - 55
* Subject agrees not to use any hand wash products on their hands other than what has been provided in the study.
* Subject agrees not to use any moisturizers or any skin products on their hands during the study
* Subject agrees to use gloves to protect hands from activities such as dish washing
* Subject is willing to sign the Informed Consent and HIPAA
* Subject agrees to comply with the study requirement

Exclusion Criteria:

* Subject has a history of psoriasis, active dermatitis, skin reactions, cracked, irritated, broken skin, skin infection on their hands
* Subject has scaly skin on hands based on Visual Scoring Scale at Day 1
* Subject has a sensitivity or history of skin reactions to any study materials (eg, alcohol, chlorhexidine gluconate or zinc pyrithone or latex in the gloves)
* Subject has been using moisturizing products or any products on their arms and hands within 5 days prior to participation in the study
* Subject is pregnant
* Study coordinator believes the subject is unsuitable for inclusion in the study

Primary outcomes:
measure: Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days
timeFrame: Baseline and 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: cyberDERM Clinical Research
name: Gary L Grove, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06661642: Clinical Prediction of Post-surgical Pain
Official title: Clinical Prediction of Post-surgical Pain: External Validation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Postoperative Pain
Chronic Post Operative Pain
Keywords: Acute postoperative pain
Chronic postoperative pain
Prediction
Risk tool
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: University Hospital Bispebjerg and Frederiksberg
First posted: 2024-10-28
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective or sub-acute surgery meeting inclusion and exclusion criteria, including thoracic, cardiac, abdominal, vascular, plastic, neurosurgery and orthopaedic surgery.

Brief summary: This study aims to externally validate two clinical prediction models for moderate-to-severe acute post-surgical pain and chronic post-surgical pain. This multi-centre, prospective cohort study will be conducted in Denmark and will include adult patients undergoing various types of elective or sub-acute surgical procedures.

Detailed description: Based on sample size calculations for prediction model validation, a total of 482 patients are required validation of the acute post-surgical pain model and 748 (575 + 30% for loss to follow-up) patients are required for validation of the chronic post-surgical pain model. Therefore, we will aim to recruit 748 patients in total.

Eligibility criteria: Inclusion Criteria:

All patients ≥ 18 years undergoing elective or sub-acute surgery

Exclusion Criteria:

Cognitive impairment not allowing for informed consent

Primary outcomes:
measure: Moderate-to-severe acute post-surgical pain
timeFrame: First 3 postoperative hours or until discharge from the PACU
measure: Chronic post-surgical pain
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: Severe acute post-surgical pain
timeFrame: First 3 postoperative hours or until discharge from the PACU
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Lone Nikolajsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01248442: Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans
Official title: Placebo Controlled Study to Assess the Effects of Vitamin D Supplementation on Parameters of the Immune, Endocrine and Metabolic System in Healthy Women and Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Humans
Keywords: Vitamin D Deficiency
Autoimmune disease
Diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this placebo controlled study the investigators aim to investigate the effect of a 3 month vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of certain immune cells, which regulate immunotolerance, the investigators therefore try to confirm these results with a placebo group. Furthermore the investigators assess the effect of vitamin D on the glucose metabolism and hormone levels.

Detailed description: This is a randomized double-blind placebo controlled trial, with the aim to investigate the effect of a Vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy humans without diabetes and obesity.

The primary aim is to assess the effect of vitamin D supplementation of the number and function of peripheral regulatory T-cells (Tregs). The investigators will measure the Tregs at baseline and monthly for 3 months. Furthermore the investigators assess additional immune cells from the adaptive immunosystem.

Furthermore the investigators will perform a standard mixed meal tolerance test at baseline and 3 months following the supplementation in order to assess the insulin secretion in vivo.

Eligibility criteria: Inclusion Criteria:

* Age \>= 10 years
* healthy subjects without chronic disease

Exclusion Criteria:

* Hypercalcemia \>2,65 mmol/L
* pregnancy and lactation period
* acute infections
* chronic disease requiring treatment

Primary outcomes:
measure: Increase and function of peripheral regulatory T-cells
timeFrame: 3 months
Secondary outcomes:
measure: immunophenotyping
timeFrame: 3 months
measure: Renin and aldosterone concentrations
timeFrame: 3 months
measure: Insulin secretion
timeFrame: 3 months
measure: calcium levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
Study officials:
affiliation: Medical University of Graz
name: Thomas R Pieber, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prietl B, Treiber G, Mader JK, Hoeller E, Wolf M, Pilz S, Graninger WB, Obermayer-Pietsch BM, Pieber TR. High-dose cholecalciferol supplementation significantly increases peripheral CD4(+) Tregs in healthy adults without negatively affecting the frequency of other immune cells. Eur J Nutr. 2014 Apr;53(3):751-9. doi: 10.1007/s00394-013-0579-6. Epub 2013 Sep 3.
Clinical trial NCT03269942: Study of Complex Intracranial Aneurysm Treatment
Official title: Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: Intracranial Aneurysm
Flow Diverter
Cerebral Revascularization
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2017-09-01
Enrollment: 110
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator expects that endovascular flow-diversion is superior over revascularization by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.

Detailed description: Open, prospective, controlled randomized superiority trial is conducted. The hypothesis is that endovascular flow-diversion is better than revascularization in treatment of complex intracranial aneurysms by postoperative modified Rankin Scale (mRS). Sample size was measured by Fisher exact test. Depending on a type of the procedure, the patients are divided into two groups: Endovascular Flow Diversion Procedure (include 55 patients) and Revascularization Procedure (include 55 patients). Randomization is performed by random number generation.The study was approved by Institutional Review Board

Eligibility criteria: Inclusion Criteria:

* anterior circulation complex intracranial aneurysm
* neck is more than 4 mm wide
* dome/neck ratio of aneurysm equals or less than 2:1
* age less than 75 years
* ability to give informed consent (subject or legally authorized representative)
* aneurysm is suitable for treatment to both procedures

Exclusion Criteria:

* subarachnoid hemorrhage less than 30 days ago
* contraindications to endovascular treatment
* atypical aneurysms (mycotic, flow-related in patients with AVM, traumatic, false)
* informed consent refusal

Primary outcomes:
measure: mRS
timeFrame: 6, 12 months after procedure
Secondary outcomes:
measure: Complete aneurysm occlusion
timeFrame: 6, 12 months after procedure
measure: Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
timeFrame: 6, 12 months after procedure
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institution of Circulation Pathology
Study officials:
References:
Clinical trial NCT01221142: Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypothermia
Primary Intracerebral Hemorrhage
Signs and Symptoms
Keywords: Hypothermia, ICH
Lead sponsor: University of Rijeka
Sponsor class: OTHER
Collaborators: name: PharmamedMado d.o.o., Zagreb, Croatia
First posted: 2010-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage.

Detailed description: The purpose of this pilot trial is to determine whether hypothermia improves neurological outcome (measured as 3 and 6 months after the onset of symptoms using mRS, GOS and BI) in patients who has suffered a primary intracerebral hemorrhage. The patients with primary intracerebral hemorrhage presented with coma (GCS ≤ 8) and ICH score 2-4 will be included. Induction of hypothermia will be initiated within 6 hours of symptoms onset. Patients will be cooled to core temperature of 34°C during 24 hours using non-invasive temperature management (Cincinnati Sub-Zero). The temperature will be measured continuously by esophageal system. After 24 hours of successful cooling, the target temperature will be gradually raised to achieve slow re-warming of 0.5°C / 2 h until the core temperature reaches 36,5°C.

During hypothermia ECG, blood pressure, oxygen saturation and intracranial pressure will be measured continuously and registered every 30 min. The first CT scan of the brain, after initial, will be done early after normothermia is reached.

Eligibility criteria: Inclusion Criteria:

* GCS ≤ 8
* ICH score 2-4
* symptom onset within 6 hours
* ages 18 - 80

Exclusion Criteria:

* pregnancy
* hemodynamical unstability
* recent myocardial infarction
* systolic blood pressure \< 90 mm Hg

Primary outcomes:
measure: Neurological outcome
timeFrame: 3 months after the onset
measure: Neurological outcome
timeFrame: 6 months after the onset
Secondary outcomes:
measure: Mortality
timeFrame: 1 week
measure: Mortality
timeFrame: 1 month
measure: Mortality
timeFrame: 6 months
measure: The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes
timeFrame: 3 days
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Intensive Care Unit, Department of Neurology, University Hospital Rijeka
Study officials:
affiliation: Intensive Care Unit, Departmen of Neurology, University Hospital Rijeka, Croatis
name: Igor Antoncic, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001142: Effect of Exercise on Metabolic Health
Official title: Effect of Exercise on Novel Insulin Signaling Events in Human Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Insulin Sensitivity
Exercise
Metabolism
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2013-12-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: One of the main objectives of this study will be to assess potential differences in important risk factors associated with Metabolic Syndrome in overweight adults who do not participate in a regular exercise program compared with overweight individuals who do exercise regularly. In addition, we will determine the effects of a single, modest session of exercise on the body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults vs. obese adults who live a physically active lifestyle. Our study focuses on identifying mechanisms responsible for improved insulin action related to regular exercise and to provide novel targets for preventing and treating type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index \[BMI\] = 30-45 kg/m2, fasting blood glucose concentration must be \< or = to125 mg/dl, Hematocrit \> or = to 34%, all women must be pre-menopausal

Exclusion Criteria:

* pregnancy or actively breastfeeding, weight instability (\> or = to ± 5 lbs in the past month) evidence of cardiovascular or metabolic diseases, taking medications know to affect lipid and/or glucose metabolism.

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 2-3 hours
Secondary outcomes:
measure: Resting Metabolic Rate
timeFrame: 20-30 min
measure: Meal Tolerance Test
timeFrame: 3 hours
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Clincal Research Unit
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey F Horowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: