louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04796480: Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea
Official title: Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Diarrhea
Keywords: LACTOSE FREE FORMULA MILK
YOGURT
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2021-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were divided in 2 groups.
Primary purpose: TREATMENT

Brief summary: This study was aimed to look at the effect of lactose free formula milk in comparison with home-made plain yogurt in children with acute watery diarrhea.

Detailed description: A randomized controlled trial using non probability consecutive sampling was carried out on 60 children (30 in each group) in Department of Paediatrics Unit I, Services Hospital Lahore. An informed written consent was taken from parents of the children. Ethical issues considered and maintained throughout the study. Then all children were randomly divided in two groups by using lottery method. In group 1; children were given yogurt while in group 2, children were given lactose free formula milk. In both groups, feed was given 5-8 times per day. Patients were followed-up till resolution of symptoms and discharge from hospital.

Eligibility criteria: Inclusion Criteria:

* Children of age 4-24 months presenting with acute diarrhea
* Both gender

Exclusion Criteria:

* Children on antibiotic therapy within 48 hours prior to presentation
* Malnourished children (-2SD as per WHO criteria)
* Children with severe dehydration requiring IV fluids
* Children \< 4 months of age (as weaning not started yet)

Primary outcomes:
measure: Effect of home-made yogurt versus lactose-free milk on mean duration of diarrhea in children with acute diarrhea
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital Lahore
state: Punjab
Study officials:
References:
citation: Kosek M, Bern C, Guerrant RL. The global burden of diarrhoeal disease, as estimated from studies published between 1992 and 2000. Bull World Health Organ. 2003;81(3):197-204. Epub 2003 May 16.
citation: Chu C, Rotondo-Trivette S, Michail S. Chronic diarrhea. Curr Probl Pediatr Adolesc Health Care. 2020 Aug;50(8):100841. doi: 10.1016/j.cppeds.2020.100841. Epub 2020 Aug 27.
citation: Forster CS, Hsieh MH, Cabana MD. Perspectives from the Society for Pediatric Research: Probiotic use in urinary tract infections, atopic dermatitis, and antibiotic-associated diarrhea: an overview. Pediatr Res. 2021 Aug;90(2):315-327. doi: 10.1038/s41390-020-01298-1. Epub 2020 Dec 7.
Clinical trial NCT04597762: Effect of Ciclosporin Eyedrops on Sjögren Syndrome
Official title: Effect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients.

Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of severe keratoconjunctivitis sicca defined by:
* Staining of the cornea ≥ grade III according to the Oxford scale
* OSDI value ≥ 12
* Age between 18 and 90 years
* Primary or secondary Sjogren's syndrome (defined according to the American-European Consensus Group criteria) with a stable course and unchanged treatment for 6 months

Exclusion criteria:

* Pregnancy (excluded with a pregnancy test in patients of childbearing potential)
* Children and young people up to the age of 18
* Eye surgery in the past 6 months
* Simultaneous participation in another study
* Regular use of eye drops, with the exception of tear substitutes
* Use of eye drops containing ciclosporin or glucocorticoids in the last 6 months

Primary outcomes:
measure: tearfilm breakup time
timeFrame: 6 months
measure: corneal fluorescein staining
timeFrame: 6 months
measure: corneal optical aberrations
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Augenabteilung - Klinik Hietzing
Study officials:
References:
Clinical trial NCT03967262: Secondary Prevention and Recidivism Reduction in Trauma Patients
Official title: Secondary Prevention and Recidivism Reduction in Trauma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma
Alcohol Use, Unspecified
Drug Use
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The consumption of alcohol and other drugs is one of the main risk factors for traumatism. In addition, patients who have suffered an accident in relation to the consumption of these substances present a high risk of recidivism. In the case of alcohol, its relationship with traumatisms has been known for many years now and is still one of the main risk factors.

Secondary prevention is an important area of action and improvement in the treatment of this type of patient by considering actions, such as a brief motivational intervention, in order to avoid recidivism. The objective of motivational intervention is to make the patient aware of the relationship between the consumption of these substances and the accident, and induce them to carry out a change in habits.

The objective of the present investigation project is to determine the efficacy of secondary prevention in reducing recurrence of traumatisms. In order to this, a multicenter randomised controlled trial has been designed in which the intervention group with patients admitted for sever traumatism with positive screening for alcohol or other drugs, will be submitted to a brief motivational intervention. The main outcome will be trauma recurrence within a three year follow-up.


Eligibility criteria: Inclusion Criteria:

* Sever trauma patients defined as the need of assistance in a critical unit.
* Positive screening for alcohol o other drugs (cannabis, cocaine, methamphetamine).

Exclusion Criteria:

* Patients in treatment for abuse of alcohol and other drugs.
* Death during hospitalization.
* Non Catalonia residents.
* Not Spanish or Catalan spoken.

Primary outcomes:
measure: Recurrence of traumatisms
timeFrame: Follow-up of 3 years
Secondary outcomes:
measure: Alcohol prevalence
timeFrame: Trough study completion, an average of 2 years
measure: Other drugs prevalence (cannabis, cocaine, methamphetamine)
timeFrame: Trough study completion, an average of 2 years
measure: Time to a recurrence
timeFrame: Trough study completion, an average of 2 years
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Parc Taulí
state: Barcelona
Study officials:
affiliation: Corporacion Sanitaria Parc Tauli
name: Salvador Navarro-Soto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporacion Sanitaria Parc Tauli
name: Salvador Navarro-Soto, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00169962: Study of Pulmozyme to Treat Severe Asthma Episodes
Official title: Use of Aerosolized rhDNase (Pulmozyme®) in Emergency Department Adults With Refractory Acute Asthma: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: acute disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2005-09-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Even with current standard ED treatments 20-25% of patients presenting to the ED with an acute asthma episode will still require hospitalization. For patients unresponsive to beta-agonists the admit rates will be higher. Of those well enough to be discharged from the ED nearly 30% will relapse within one month. More than 5,000 patients with asthma still die each year in the USA. For patients who do not respond to beta-agonists, there are relatively few treatment options for rapid improvement of symptoms and pulmonary function. Presumably, mucous secretion and plugging play an important role in the pathogenesis of severe asthma unresponsive to beta-agonists. The use of agents to promote clearance of intra-luminal secretions and mucous plugs may represent an important advance in the management of acutely ill asthmatics, both to hasten recovery and prevent deterioration in the acute care setting and to prevent relapse after discharge from the ED.

OBJECTIVES

2.1 Study Hypothesis: rhDNAse can be safely used in patients presenting to the Emergency Department with acute moderate-severe asthma who do not have adequate responses to beta-agonists

Project Specific Aim: This is a pilot study to determine the safety of three different doses of pulmozyme® (2.5mg, 5.0mg and 7.5mg) in patients presenting to the ED with acute asthma. In addition to safety trends for improvement in pulmonary function and clinical outcomes will be monitored and data analyzed. Based on the safety profile and observable responses to treatment, this information may be used to develop larger trials to determine the efficacy and dosing strategy for treating acutely ill asthmatics with rhDNAse.


Eligibility criteria: Inclusion Criteria:

acute asthma FEV1\<60% post-standard care age 18-55 years -

Exclusion Criteria:

other chronic lung illness pregnancy -

Primary outcomes:
measure: FEV1
Secondary outcomes:
measure: Hospitalization
Other outcomes:
Locations:
city: Queens
country: United States
facility: LIJMC
state: New York
Study officials:
affiliation: LIJMC
name: Robert A Silverman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silverman RA, Foley F, Dalipi R, Kline M, Lesser M. The use of rhDNAse in severely ill, non-intubated adult asthmatics refractory to bronchodilators: a pilot study. Respir Med. 2012 Aug;106(8):1096-102. doi: 10.1016/j.rmed.2012.04.002. Epub 2012 May 12.
Clinical trial NCT03824262: The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position
Official title: The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temperature Change, Body
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period.

Detailed description: The patients will be randomized into two groups. All patients will receive prewarming with forced-air warming device for 30 minutes. All patients will receive warmed fluids during intraoperative period. One group will receive warming with only forced-air warming device and the other group will receive warming with both forced-air warming device and water mattress. Timpanic, esophageal and peripheral temperature monitoring will be performed.

Eligibility criteria: Inclusion Criteria:

* Major abdominal surgery in litotomy position
* ASA I-II
* Anticipated operation time over 1 hour

Exclusion Criteria:

* Sepsis
* Hypothermia
* Hyperthermia
* Malignant Hyperthermia
* Tyroid dysfunction

Primary outcomes:
measure: Body temperature-esophageal probe
timeFrame: Perioperative period-every 15 minutes
Secondary outcomes:
measure: Body temperature-tympanic thermometer
timeFrame: Perioperative period-every 15 minutes
measure: Body temperature-skin thermometer
timeFrame: Perioperative period-every 15 minutes
measure: Duration of operation
timeFrame: Perioperative period
measure: Blood loss
timeFrame: Perioperative period
measure: Shivering after the operation
timeFrame: Postoperative 1st hour every 10 minutes
measure: Time to extubation
timeFrame: The end of the operation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine Hospital
Study officials:
affiliation: Hacettepe University
name: Meral Kanbak, Prof
role: STUDY_CHAIR
affiliation: Hacettepe University
name: FİLİZ UZUMCUGIL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01736462: Corneal Endothelial Cell Density Changes, When Mapracorat Ophthalmic Suspension 3%, is Administered for 14 Days
Official title: An Open-Label Study to Evaluate 3 Month Corneal Endothelial Cell Density Changes in Healthy Subjects When Mapracorat Ophthalmic Suspension, 3%, is Administered 4 Times Daily for 14 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Corneal Endothelial Cell Changes
Keywords: Cornea
Endothelial cell density
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study is to evaluate the effect on corneal endothelial cell density (cells/mm²) changes at 3 months when mapracorat ophthalmic suspension, 3% is administered QID (four times daily), for 14 days in healthy subjects with a normal ophthalmic history.


Eligibility criteria: Inclusion Criteria:

* Must have a Pinhole visual acuity (VA) equal to or better than 20/40 in both eyes.
* Must be in good ocular health

Exclusion Criteria:

* Subjects who have known hypersensitivity or contraindication to the study drug or its components.
* Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
* Any topical ophthalmic medication, including tear substitutes that cannot be discontinued during the study.
* Subjects who are monocular (fellow eye is absent or fellow eye's Pinhole VA is worse than 20/200).
* Subjects with a history of ocular surgery, or who anticipate ocular surgery in either eye within the study period.
* Presence of significant ocular or systemic disease that the Investigator determines could interfere with the study.

Primary outcomes:
measure: Endothelial Cell Density
timeFrame: 3 months (Visit 4)
Secondary outcomes:
measure: Area under the plasma concentration-time curve
timeFrame: Day 1 (Visit 2)
measure: Area under the plasma concentration-time curve
timeFrame: Day 15 (Visit 3)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Inc
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Quintus Ngumah, OD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03718962: The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
Official title: The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brief Description of Focus of Study Instead
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitiligo is a relatively common acquired disorder of pigmentation characterized by the development of well-defined white macules on the skin. Biopsies of lesional skin reveal a loss of epidermal melanocytes. Lesions may occur in a localized or generalized distribution and may coalesce into large, depigmented areas. Given the contrast between the white areas and normal skin, the disease is most disfiguring in darker skin types and has a profound impact on the quality of life of both children and adults . Patients with vitiligo often experience stigmatization, social isolation, and low self-esteem. The therapys include topical steroids, topical immunosuppresant, systemic steroids, phototherapy, and surgery.

The aim of this study is to investigate the effect of phototherpy and accupuncture combined therapy for vitiligo patients.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Vitiligo

Exclusion Criteria:

* pregnancy
* immune disorder
* infection
* other dermatosis in treating areas

Primary outcomes:
measure: repigmentation
timeFrame: 12weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: ShinKongHospital
Study officials:
References:
Clinical trial NCT00120562: Studies of Biological Changes Related to Weight Loss After Gastric Bypass Surgery
Official title: A Gene Expression and Metabolic Profile of Weight Loss: Studies of Patients Following Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Morbid Obesity
Weight Loss
Keywords: weight loss surgery
gastric bypass surgery
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: New York Obesity and Nutrition Research Center
First posted: 2005-07-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* 18 - 65 years old
* Subjects approved for gastric bypass surgery

Brief summary: Weight loss achieved by dieting induces multiple changes. These changes include a decrease in metabolic rate (the rate in which the body burns its calories), an increase in appetite and other physiological and hormonal changes that may be the cause of failure in dieting. Many of these parameters that have never been evaluated when weight is lost after gastric bypass surgery will be tested in this study.

Detailed description: While gastric bypass surgery (GBS) is known to be highly effective in achieving significant weight loss, it is also associated with other biologic changes that occur in the body when weight is lost. In this study, subjects undergoing gastric bypass surgery will be followed throughout the weight loss period. They will undergo four detailed medical evaluations to assess changes in several biological systems that occur in the body when weight is lost.

The initial assessment will be performed before the surgery (testing period 1). After surgery is completed, subjects will attend clinic visits at the Rockefeller University outpatient clinic. During these visits, weight and leptin levels will be monitored. Two additional assessments will be performed during weight loss, when subjects lose 10% and 20% of their initial weight (testing periods 2 and 3 respectively). A final evaluation will be performed after weight is stabilized, about 18 months after the surgery is completed (testing period 4). Each testing period will be performed over a 2 week period in an inpatient setting at the Rockefeller University Hospital. During testing periods subjects will undergo a series of metabolic, behavioral, hormonal, immune and molecular tests to evaluate changes that occur in the body after weight loss. Subjects will receive monetary compensation for participating in the study.

Eligibility criteria: Inclusion Criteria:

* 18 - 65 years old
* Subjects approved for gastric bypass surgery

Exclusion Criteria:

* Subjects not approved for gastric bypass surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's Obesity Research Center, NY NY 10023 and New York Hospital
state: New York
Study officials:
affiliation: Rockefeller University
name: Jeffrey M. Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06608862: The Impact of Hormonal Contraceptive Use and Lifestyle Factors on Fracture Risk and Bone Quality in Young Female Adults
Official title: The Impact of Hormonal Contraceptive Use, Body Composition, Muscular Strength and Iron Status on Fracture Risk and Bone Quality in Adult Females from 18-35 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis
Osteopenia
Fracture Reduction
Body Composition
Nutrition
Hemoglobin
Muscle Strength
Bone Density
Contraception Behavior
Physical Activity
Menstrual Irregularities
Keywords: impact of lifestyle factors on bone quality
impact of hormonal contraceptive use on bone quality
impact of body composition on bone quality
impact of nutrition and energy balance on bone quality
impact of amenorrhea on bone quality
impact of physical activity on bone quality
impact of the occupation soldier on bone quality
impact of muscle strength on bone quality
Lead sponsor: Bundeswehr University Munich
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female soldiers between 18-35 years.

Brief summary: The study on hand is based on a cross-sectional design and aims to acquire 1) descriptive data on the physical state and health condition of female soldiers in the German armed forces. 2) a possible influence of different contraceptive methods as well as physical activity, body composition, strength, nutrition, and hemoglobin levels on bone health should be investigated.


Eligibility criteria: Inclusion Criteria:

* 18 - 35 years
* female
* willing to participate under a pseudonym
* occupational soldiers
* free from chronic or acute musculoskeletal injury

Exclusion Criteria:

* for the bioelectrical impedance: electronic implants like defibrillator, pregnancy

Primary outcomes:
measure: T-Score
timeFrame: Measured at baseline and at 12 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University of the Bundeswehr Munich
state: Bayern
Study officials:
References: