louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01482208: Clinical Evaluation of Ultrasonic Hydration Monitor for Infants
Official title: Study of Ultrasonic Hydration Monitor for Neonatology and Pediatric Children and Infants and/or Children up to Age 3 Years Old With Diarrhea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhea
Dehydration
Keywords: Dehydration
Hydration
Muscle composition
Diarrhea
Pediatrics
Neonatology
Ultrasound
Lead sponsor: Artann Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2011-11-30
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns from 1 to 7 days Small children from 1 month to 3 years old

Brief summary: Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration status in newborns and infants by means of ultrasound velocity measurements through muscle tissues. Changes of tissue hydration will be followed during first days of life in newborns and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical dehydration symptoms will be used as controls.


Eligibility criteria: Inclusion Criteria:

* Newborns from 1 to 7 days old,
* Health infants from 1 month to 3 years old,
* Any ethnicity,
* Male or female,
* Infants with diarrhea,
* Acute gastroenteritis,
* Diarrhea and/or vomiting,
* Suspected dehydration

Exclusion Criteria:

* Congenital heart disease,
* Renal failure,
* Chronic liver disease,
* Chronic lung disease,
* Inflammatory bowel disease,
* Immune deficiency,
* Severe malnutrition,
* Any external damage to skin of leg,
* Infants and Children whose parents refuse permission to be included

Primary outcomes:
measure: Assess the ability of IHM to measure changes of hydration status ni newborn and infants
timeFrame: 1 week to several months
Secondary outcomes:
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)
Study officials:
affiliation: Head of Pediatrics, CCUH RSU
name: Dace Gardovska, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00689208: Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity
Official title: Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity - a Concept Study in Mani
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Insulin Resistance
Keywords: Clamp
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The present study on pharmacological intervention in autonomic nervous dysregulation(parasympathetic dysfunction,) regarding insulin resistance, is a concept testing in humans tohelp identify potential new pharmacological target sites in the central nervous system.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* BMI of lean and abdominally obese men and women
* weight stable

Exclusion Criteria:

* Ongoing clinically significant diseases
* History of repeated syncope
* resting pulse\<50 or systolic blood pressure \<100

Primary outcomes:
measure: Study the effect of anticholinergic drugs on insulin sensitivity by assessment of glucose infusion rate during hyperinsulinemic euglycemic clamp.
timeFrame: After Insulin bolus, following will be measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
Secondary outcomes:
measure: Study the effect of cholinergic stimulation on insulin sensitivity by assessment ofglucose infusion rate during hyperinsulinemic euglycemic clamp.
timeFrame: measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
measure: Study the possible difference in effect of cholinergic (physostigmine) andanticholinergic (atropine) drugs on insulin sensitivity in a lean and abdominal obese subgroup of subjects.
timeFrame: measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: Lundberg Laboratory for diabetic research, Sahlgrenska Universitetssjukhuset Göteborg, Sweden
name: Per-Anders Jansson, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Cardiovascular gastrointestinal departmentAstraZeneca R&D Mölnda Swedenl
name: Jan Eriksson, MSD
role: STUDY_CHAIR
References:
Clinical trial NCT05565508: Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery
Official title: a Prospective Randomized Controlled Trial Evaluating Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-10-04
Enrollment: 172
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: the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery

Detailed description: the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery and comparing the new technique group (A) patients to already known technique called (Hasson's technique) group (B) patients

Eligibility criteria: Inclusion Criteria:

* Patients more than 18 year-old with history of previous abdominal and/or pelvic surgery.
* underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to july, 2022.

Exclusion Criteria:

* Patients with distended abdomen due to bowel obstruction.
* Patients with uncorrected coagulopathy.

Primary outcomes:
measure: time needed to access the peritoneal cavity
timeFrame: the first 15 minutes of operation
measure: numbers of trials till the good peritoneal access achieved
timeFrame: the first 15 minutes of operation
Secondary outcomes:
measure: rate of complications
timeFrame: the first 15 minutes of operation
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
References:
Clinical trial NCT05408208: Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis
Official title: Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Localized Psoriasis
Keywords: Intralesional Injection ,Methotrexate, localized Psoriasis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the efficacy of intralesional injection of methotrexate in comparison with Intralesional Injection of Triamcinolone Acetonid in localized psoriasis (body surface area \< 10%) .

Detailed description: study enrolling 30 patients of localized psoriasis. 15 patients received intralesional methotrexate :

* Taking aseptic condition ,One psoriatic plaque will treated with Intralesional injection of methotrexate (25mg /ml) at dosage of 0.1 ml /cm2.
* Another plaque will treated with intralesional ingection of distilled water as controlled plaque.
* patient will receive oral folic acid 5mg tablet every day except the day of injection.

Other 15 patients received intralesional trimethinolone acetonide:

* Taking aseptic condition , One plaque will treated with Intralesional injection of trimethinolone acetonide (10mg/ml) at dosage of 0.1 ml/ cm2 .
* another plaque will treated with Intralesional injection of distilled water as controed plaque.
* Patients will take 6 sessions every 2 weeks for 3 months and will followed up at 2 month and 3 months after treatment .

Eligibility criteria: Inclusion Criteria:

* patients with localized Psoriasis (body surface area\<10%)

Exclusion Criteria:

* Patient refusal. Generalized psoriasis. Pregnancy. Lactation. Immunocompromised patients . Patients with history of hypersensitivity to methotrexate. Patients with other inflammatory skin disorders. Patients with chronic hepatic, renal , pulmonary ,or haematological disorders. patients on treatment for psoriasis .

Primary outcomes:
measure: Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis
timeFrame: 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Gehad Hamdy Abd El-Gaber
name: Gehad Hamdy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01991808: Suitability of DCE-MRI for Detection of Vascular Changes After VBT
Official title: A Pilot Study to Assess the Suitability of DCE-MRI for Detection of Vascular Changes After Vaginal Brachytherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age.
* Must have histologically confirmed carcinoma of the cervix, carcinoma or carcinosarcoma of the uterus.
* Subjects are receiving intracavitary brachytherapy.
* ECOG performance status of 0-2.
* Creatinine clearance 30.

Exclusion Criteria:

* Subjects with an inability to tolerate MR imaging (i.e. claustrphobia)
* Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants.
* Patients who do not speak or read English.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02501408: Comparing New Prothesis PROPRIO-FOOT® Versus Usual Prothesis Tasks Tibial Amputees
Official title: Comparaison du Pied Bionique Proprio-Foot® Versus le Pied Habituel Chez Les amputés Tibiaux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Limb Amputation at Ankle (Injury)
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluate a new porosthetic device in lower limb amputees.

Detailed description: Randomisation between usual and new prosthesis Cross over study of walking performance and VO2 on treadmill with the two devices after 1 month adaptation to each system.

Eligibility criteria: Inclusion Criteria:

* Tibial amputation
* Ability top walk on treadmill
* Stable prosthesis for at least 3 months

Exclusion Criteria:

* Bilateral amputation
* Cancer
* Absence of consent

Primary outcomes:
measure: oxygen consumption
timeFrame: 1 mois after adpatation of the selected device
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: University Hospital, Angers
name: Pierre Abraham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05653908: REThinkAcademy: Helping Universities to Effectively Care for the Mental Health of College Students in the Digital Age
Official title: REThinkAcademy: Helping Universities to Effectively Care for the Mental Health of College Students in the Digital Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2022-12-16
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The project aims at monitoring mental health and its mechanism in the student population using a longitudinal design and ecological momentary assessment procedure throughout the first semester of college.


Eligibility criteria: Inclusion Criteria:

* student in Babes-Bolyai University in the first year

Exclusion Criteria:

* incapacity of accessing the mobile app

Primary outcomes:
measure: Rational and irrational beliefs
timeFrame: baseline, pre-intervention
measure: Changes in rational and irrational beliefs
timeFrame: immediately after the intervention
measure: Fluctuation in rational and irrational beliefs
timeFrame: during the intervention
measure: Mental Health
timeFrame: baseline, pre-intervention
measure: Changes in Mental Health
timeFrame: immediately after the intervention
measure: Fluctuation in Mental Health
timeFrame: during the intervention
measure: Mood disorders
timeFrame: baseline, pre-intervention
measure: Changes in mood disorders
timeFrame: Post-intervention (one week after the intervention)
measure: Fluctuation in mood disorders
timeFrame: during the intervention
measure: Fluctuation in academic stress
timeFrame: during the intervention
measure: Fluctuation in life experiences
timeFrame: during the intervention
measure: Fluctuations in emotion regulation
timeFrame: during the intervention
measure: Fluctuations in college student stress
timeFrame: during the intervention
measure: Fluctuations in stress coping styles
timeFrame: during the intervention
measure: Student adaptation to college
timeFrame: during the intervention
Secondary outcomes:
measure: Trauma
timeFrame: baseline, pre-intervention
measure: Loneliness
timeFrame: baseline, pre-intervention
measure: Fluctuation in loneliness
timeFrame: during the intervention
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
References:
Clinical trial NCT01235208: The Effect of the Treatment Program "Dr. Fedon Lindbergs Vektcoach" on Body Weight and Composition and Hormonal Profile
Official title: The Effect of a Low Carbohydrate Low Energy Ketogenic Diet Followed by Progressively Increased Intake of Low Glycemic Foods Over 7 Months on Weight and Body Composition and Hormonal Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Metabolic Syndrome
Keywords: Overweight
Obesity
Metabolic syndrome
Diet
Carbohydrate
Low glycemic index
Eurodiet
Lead sponsor: Eurodiet Scandinavia AS
Sponsor class: INDUSTRY
First posted: 2010-11-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The background for the trial is a number of previous studies indicating that it is especially important to restrict the intake of carbohydrates when treating overweight and metabolic diseases in general.

The purpose of the study is to obtain research data on the effects of an established treatment of overweight/obesity and its related metabolic disorders. The treatment, "Dr. Fedon Lindbergs Vektcoach", is a combination treatment where patients use low carbohydrate and low energy "Eurodiet" products in the initial phases. After the initial phases are completed, low glycemic normal foods are added to the diet until a sustainable and healthy diet is achieved. The treatment is of 7 month duration.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI)\>35
* BMI\>27 + one risk factor for cardiovascular disease or metabolic syndrome
* \>18 years

Exclusion Criteria:

* Medicinal treatment of thyroid disease
* Pregnancy or planned pregnancy
* Taking of diet pills like Xenical or Sibutramine

Primary outcomes:
measure: Body weight/composition
timeFrame: 7 months
Secondary outcomes:
measure: Hormonal profile
timeFrame: 7 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dr. Fedon Lindbergs Klinikk
Study officials:
name: Pål T Jåbekk, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Unaffiliated/ Study supervisor
name: Arne T Høstmark, Ph.D/Dr.Med
role: STUDY_DIRECTOR
References:
Clinical trial NCT05062408: Impact of the Sustained Viral Response of Chronic Hepatitis c After Treatment With Direct Action Antivirals
Official title: Impact of the Sustained Viral Response on the Natural History Chronic Hepatitis c After Treatment With Direct Action Antivirals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 321
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population are patients with chronic hepatitis C who have been treated with direct-acting antivirals between 2014 and 2017. Also patients with fibrosis and liver cirrhosis.

Brief summary: The purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved SVR after treatment with direct-acting antivirals.

Detailed description: This open study includes patients with chronic hepatitis C who received treatment with the new direct-acting antivirals between November 1, 2014 and December 31, 2017, who achieved a sustained viral response at week 12.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic liver disease caused by virus C.
* Have received treatment with the new DAAs between November 1, 2014 and December 1, 2017.
* Patients diagnosed with advanced fibrosis and liver cirrhosis. Advanced fibrosis was defined as a Fibroscan\> 10 kPa, an APRI index\> 1.5 and / or a FIB-4 index\> 3.25. For its part, cirrhosis was defined such as a Fibroscan\> 12.5 kPa and / or presence of esophagogastric varices in the endoscopic study and / or data portal hypertension ultrasound.

Exclusion Criteria:

* Coinfection by virus B or HIV.
* Development of HCC before or during treatment.
* Abuse of alcohol intake or addiction to parenteral drugs.
* Liver disease of non-viral etiology (autoimmune, toxic, metabolic).

Primary outcomes:
measure: Number of patients with a progression of liver injury.
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Identify patients who develop liver-related events (liver decompensation, hepatocellular carcinoma, and death) after achieving sustained viral response.
timeFrame: Up to 4 weeks.
measure: Rate of risk factors presented by patients.
timeFrame: Up to 4 weeks.
measure: Absence of improvement in non-invasive fibrosis parameters vs the development of liver complications.
timeFrame: Up to 4 weeks.
measure: Clinical and fibrosis data.
timeFrame: Up to 4 weeks.
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Paula Fernández Álvarez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02870608: Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat
Official title: Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Obstetric Labor, Premature
Keywords: Elastography
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study was to evaluated the feasibility and reproducibility of the measurement of lung elasticity report / fetal liver according to gestational age in a group of patients with a normal course of pregnancy and in a group of Patients at risk of preterm delivery.


Eligibility criteria: Inclusion Criteria for control group :

* major pregnant women
* singleton pregnancy

Inclusion Criteria for control group :

* major pregnant women
* singleton pregnancy
* hospitalized for threatened premature birth between 24 and 34 WA
* Indication of a cure corticosteroid betamethasone

Exclusion Criteria:

* maternal conditions of pregnancy: diabetes gestational, pregnancy-induced hypertension, preeclampsia
* fetal lung diseases

Primary outcomes:
measure: Evolution over 48 hours of the fetal lung elasticity coefficient measure in kilopascals (kPa) (compared to the fetal liver)
timeFrame: For pretern larbor group: day of hospitalization for preterm labor, then 2 days later. For control group, both measurements at 2-day intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
citation: Mottet N, Aubry S, Vidal C, Boiteux G, Metz JP, Riethmuller D, Pazart L, Ramanah R. Feasibility of 2-D ultrasound shear wave elastography of fetal lungs in case of threatened preterm labour: a study protocol. BMJ Open. 2017 Dec 26;7(12):e018130. doi: 10.1136/bmjopen-2017-018130.