louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00439491: Role of Adipose Tissue in Pathogenesis of Insulin Resistance
Official title: Role of Adipose Tissue in Pathogenesis of Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: Obesity
Insulin resistance
Hypocaloric diet
Adipose tissue
adipocytokine
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2007-02-23
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. In addition, body composition and insulin resistance are measured before and during the diet.

Detailed description: The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet without any medication and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. Adipose tissue samples are obtained using needle biopsy. In addition, before and during the diet,body composition is measured using multifrequency bioimpedance and insulin resistance is evaluated using either hyperinsulinemic clamp or glucose/insulin - derived indices.

Eligibility criteria: Inclusion Criteria:

* Obesity

Exclusion Criteria:

* Diabetes
* Coronary heart disease
* Eating disorders
* Medication of beta blockers
* Medication of antiobesity drugs

Primary outcomes:
measure: Body weight
measure: Body fat
Secondary outcomes:
measure: Insulin resistance
measure: Adipocytokine plasma levels
measure: Adipocytokine adipose tissue expression
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Third Faculty of Medicine, Charles University in Prague
Study officials:
affiliation: Third Faculty of Medicine, Charles Uniersity in Prague
name: Vladimir Stich, Ass Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00637091: Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
Official title: A Phase II Trial of Cetuximab Plus Irinotecan as a 2nd-line Treatment in Patients With Metastatic Colorectal Cancer After Failure to Irinotecan That Express Wild-type KRAS With and Without Detectable EGFR Expression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Colorectal Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2008-03-17
Enrollment: 40
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 investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.

Detailed description: Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.

Eligibility criteria: Inclusion Criteria:

* Colorectal adenocarcinoma, Wild KRAS, 18-75 yr
* Estimated life expectancy of more than 3 months
* ECOG performance status of 0 to 1 at study entry
* Adequate bone marrow function
* Adequate liver function
* Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
* Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
* Informed Consent

Exclusion Criteria:

* Central nervous system (CNS) metastases or prior radiation for CNS metastases.
* Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
* Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
* Evidence of gastrointestinal bleeding
* Exposure to Cetuximab
* Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
* KRAS mutant Status
* Patients with serious toxicity to previous irinotecan-based chemotherapy
* Other serious illness or medical conditions

Primary outcomes:
measure: Response rate
timeFrame: 8 week
Secondary outcomes:
measure: Progression free survival, overall survival
timeFrame: every 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Kang MJ, Hong YS, Kim KP, Kim SY, Baek JY, Ryu MH, Lee JL, Chang HM, Kim MJ, Chang HJ, Kang YK, Kim TW. Biweekly cetuximab plus irinotecan as second-line chemotherapy for patients with irinotecan-refractory and KRAS wild-type metastatic colorectal cancer according to epidermal growth factor receptor expression status. Invest New Drugs. 2012 Aug;30(4):1607-13. doi: 10.1007/s10637-011-9703-8. Epub 2011 Jun 25.
Clinical trial NCT06806891: Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis
Official title: Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemolysis
Restless Legs Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the restless leg syndrome is a common complaint in person who undergo hemodialysis. Buddhist walking meditation efficacy was not investigated in those population

Detailed description: the total participants will be 40. all patients will be on hemodialyis. they complain restless leg syndrome. the participants will be divided to group I which received Buddhist walking meditation. this program of meditation will be 30 minutes thrice weekly. before and after buddhist meditation walking, there will be 5 minutes stretching exercises working as warm up or cooling down respectively. the other group will serve as control one .. the number of patient in every group will be 20. the total duration of Buddhist walking meditation will be 12 weeks.

Eligibility criteria: Inclusion Criteria:

* hemodialysis patient (40)
* complain of restless leg syndrome
* non obese patients

Exclusion Criteria:

* cardiac patients
* chest diseases
* mental diseases
* hepatic diseases
* lower limb orthopedic hurting

Primary outcomes:
measure: international RLS Study Group Rating
timeFrame: it will be measured after 12 weeks
Secondary outcomes:
measure: Pittsburg sleep quality index
timeFrame: it will be measured after 12 weeks
measure: fatigue severity scale
timeFrame: it will be measured after 12 weeks
measure: sit to stand test
timeFrame: it will be measured after 12 weeks
measure: physical component of short form 12
timeFrame: it will be measured after 12 weeks
measure: mental component of short form 12
timeFrame: it will be measured after 12 weeks
measure: beck depression inventory
timeFrame: It will be measured after 12 weeks
measure: Trait Anxiety Inventory
timeFrame: it will be measured after 12 weeks
measure: diatolic blood pressure
timeFrame: it will be measured after 12 weeks
measure: systolic blood pressure
timeFrame: it will be measured after 12 weeks
measure: cortisol
timeFrame: It will be measured after 12 weeks
measure: C reactive protein
timeFrame: It will be measured after 12 weeks
measure: nitric oxide
timeFrame: It will be measured after 12 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: faculty of physical therapy Cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Ali MA Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01131091: A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
Official title: A Phase 1, Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)

Detailed description: This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each) as follows:

Group A: Subjects with ESRD who are receiving hemodialysis treatment

Group B: Subjects with severe renal impairment

Group C: Subjects with moderate renal impairment

Group D: Subjects with mild renal impairment

Group E: Healthy subjects

Eligibility criteria: Inclusion Criteria:

* Subject is an adult male or female aged 18 to 79 years, inclusive.
* All female subjects (that are not 2 years postmenopausal with a documented serum follicle stimulating hormone level \>35 mIU/mL) must have a negative serum pregnancy test at Screening and upon Check in to the study clinic.
* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

* Subject has a BMI \>37 kg/m2.
* Subject has taken any prescribed systemic or topical medication
* Subject has donated more than 450 mL of blood within 30 days before the start of dosing.
* Subject has received an investigational drug within 30 days before dosing.
* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption.
* Subject has had a clinically significant illness

Primary outcomes:
measure: The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403.
timeFrame: 72 Hours
Secondary outcomes:
measure: The secondary objective is to determine the safety and tolerability of a single 400 mg dose of SK 0403 in subjects with renal insufficiency.
timeFrame: 72 Hours
Other outcomes:
Locations:
city: Orlando
country: United States
state: Florida
city: Minneapolis
country: United States
state: Minnesota
Study officials:
References:
Clinical trial NCT06279091: Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction
Official title: Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Anxiety
Keywords: Dental anxiety
Parental anxiety
Breathing Exercises
Bubble Blower Breathing
Diaphragmatic Breathing
Relaxation
Distruction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Selected children will be divided randomly into 3 groups:

Control group (Group I). Diaphragmatic Breathing group (Group II). Bubble Blower Breathing group (Group III).
Primary purpose: OTHER

Brief summary: The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction.

Detailed description: This study evaluated The Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction

Eligibility criteria: Inclusion Criteria:

* Children aged 5_8 years old.
* Moderate or severe dental anxiety based on the (CDAS).
* Good general health, free from any systemic diseases or psychological disorders.
* Teeth indicated for restoration treatment under local anesthesia.
* No allergy to anesthetic drugs

Exclusion Criteria:

* Use of analgesics before treatment.
* Presenting with acute pain and requiring emergency dental treatment.

Primary outcomes:
measure: scale of dental anxiety by Corah Dental Anxiety Scale (CDAS)
timeFrame: up to 12 Weeks
measure: scale of dental anxiety by Facial Image Scale (FIS)
timeFrame: up to 12 Weeks
measure: scale of dental anxiety by Venham Clinical Anxiety Scale (VCAS)
timeFrame: up to 12 Weeks
measure: scale of dental anxiety by Pulse Oximeter
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansura University
state: Dakahlia
Study officials:
affiliation: Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University
name: Alaa M Albakr, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
name: Salwa M Awad, Prof
role: STUDY_DIRECTOR
affiliation: Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University
name: Rizk A Elagamy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04326491: The Utility of Breath Biopsy as a Screening Tool for HCC
Official title: The Utility of Breath Biopsy as a Screening Tool for HCC: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Cirrhosis, Liver
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is open for participants with liver Cirrhosis (without HCC allocated to an arm) and (with HCC allocated to the other arm). There is no gender restriction.

Brief summary: The aim of this pilot study is to examine whether there is a discriminating ability of the breath sample analysis to capture biomarkers specific to the HCC in the breath of affected individuals. If positive, our research could open up a new horizon for cost-effective and feasible screening tools.

Detailed description: 20 Participants will be included in the study. Ten Cirrhotic patients with HCC and 10 Cirrhotic patients without HCC.

The first group is patients with HCC secondary to cirrhosis. The second group will be patients with cirrhosis who are currently on the standard surveillance program with no HCC. Confirmation of the absence of HCC would have been ensured via a recent advanced imaging modality (dynamic CT scan or MRI) in the ongoing surveillance programme.

Participants will breathe into either a mouthpiece or collection tube then Breath samples will be analyzed via an analyzer to detect the volatile organic compounds (VOC) and quantitatively compare them

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients with HC.
* Cirrhotic patients without HCC

Exclusion Criteria:

* Patients with more than one primary cancer (HCC in addition to other cancer)
* Patients who are not aware of the diagnosis
* Patients in whom the diagnosis of HCC is not clear and only suspected
* Patients with severe chronic obstructive pulmonary disease (COPD) or severe asthma.

Primary outcomes:
measure: Volatile organic compounds specific to HCC
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Ashis Mukhopadhya
Study officials:
affiliation: NHS Grampian
name: Mohamed Bekheit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01858844: Chest Compression Technique in Infants
Official title: EVALUATION OF THE EFFECTS OF MANUAL CHEST COMPRESSION TECHNIQUE IN INFANTS WITH PULMONARY ATELECTASIS- Clinical CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 38
Sex: ALL
Minimum age (years): 29
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of chest manual compression technique (CCT) in the variables of oxygenation, hemodynamic and respiratory work in infants with respiratory diseases that are associated with atelectasis.


Eligibility criteria: Inclusion Criteria:

Group A

* Infants (29 days to 24 months of age).
* After the legal representatives of the patients have read agreed and signed an informed consent
* Infants diagnosed with atelectasis by medical staff, with chest x-ray with opacification directors
* Respiratory disease

Group B (control group)

* Infants whose inpatient diagnosis has not been respiratory ailments that did not show any pain at the time of the evaluation.

For the control group followed the same evaluation criteria of group A.

Exclusion Criteria:

* Infants with respiratory disorders that don't have with atelectasis
* Infants who showed signs of irritability or intense crying at the time of evaluation

Primary outcomes:
measure: Changes in clinical signs
timeFrame: baseline, within one minute after and 10 min after CCT
Secondary outcomes:
measure: Changes in signs of respiratory distress
timeFrame: baseline, within one minute after and 10 min after CCT
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Mandaqui
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Evelim Leal de Freitas D Gomes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884844: Vitamin D Supplementation for Bipolar Depression
Official title: Randomized Double-Blind Placebo-Controlled Pilot Study of Vitamin D Supplementation for the Treatment of Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Bipolar Depression
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 33
Sex: ALL
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: The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression.


Eligibility criteria: Inclusion Criteria:

* Adults \>18years old
* Bipolar disorder (I,II or NOS),
* MADRS Score\>7 (mild),
* 25(OH)D level \<30ng/ml (insufficient).
* able to take the prescribed vitamin D by mouth

Exclusion Criteria:

Systemic diseases such as:

* liver and kidney diseases,
* known parathyroid disorder,
* disorders of vitamin D metabolism,
* taking vitamin D replacement therapy,
* fat digestion disorder,
* diabetes mellitus,
* gi surgery
* If the serum calcium in the range 2.50-2.55 mmol L, inclusion required a serum PTH below 5.0 pmol L-acute psychiatric urgency:
* active suicidality,
* acute psychosis,
* active substance use\<6mo or
* pregnant or nursing females

Primary outcomes:
measure: Change in Montgomery-Åsberg Depression Rating Scale
timeFrame: baseline and at 12 week completion
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusettes
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts School of Medicine
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Wendy Marsh, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01171144: Trends Over Time (1990-2010) of Diarrhoea-related Incidence, Hospitalizations and Deaths in Children of Panama
Official title: Time Trend Analysis of Diarrhoea-related Incidence, Hospitalizations, and Deaths in Children < 5 Years of Age in Panama by Monitoring Secondary Data Sources From 1990-2010
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-28
Enrollment: 1
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children \<5 years of age reported with gastroenteritis, gastroenteritis related hospital discharges and gastroenteritis related deaths in Panama, between 1990 and 2010.

Brief summary: This study aims at collecting data from secondary sources to obtain baseline incidence and monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis related hospital discharges and gastroenteritis related deaths in children \< 5 years of age in Panama before and after implementation of Rotarix™ universal mass vaccination.

Detailed description: Data will be collected from systematic review of the databases of epidemiologic surveillance system, hospital discharges and deaths for all cause gastroenteritis related outcomes.

Eligibility criteria: Inclusion Criteria:

* Diarrhea cases, diarrhea associated hospital discharges, and diarrhea related deaths occurring in children \<5 years of age during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, in the mortality database of the Contraloría General de la República and in the hospital discharge records of the selected hospitals, will be collected for the study.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Occurrence of all cause reported gastroenteritis
timeFrame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
measure: Occurrence of all cause gastroenteritis related hospital discharges
timeFrame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)
measure: Occurrence of all cause gastroenteritis related deaths.
timeFrame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
Secondary outcomes:
measure: Occurrence of all cause gastroenteritis-related cases by year, age groups and region
timeFrame: From 1990 to 2010
measure: Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting
timeFrame: From 2000 to 2010
measure: Occurrence of all cause gastroenteritis related deaths by year, age groups and region
timeFrame: From 1990 to 2010
Other outcomes:
Locations:
city: Panama
country: Panama
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: