louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00138047: Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: zinc
HIV
children
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: University of KwaZulu
name: Grey's Hospital
First posted: 2005-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the study is to rule out a harmful effect of zinc supplementation in HIV-1-infected children. The null hypothesis is that zinc supplementation will increase plasma HIV RNA levels.

Detailed description: A randomized, double-blind, placebo-controlled equivalence trial of zinc supplementation was conducted at Grey's Hospital in Pietermaritzburg, South Africa. Ninety-six HIV-1-infected children were randomly assigned to receive 10 mg of elemental zinc as sulfate or placebo daily for 6 months. Baseline measurements of plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were established at two study visits prior to randomization, and measurements were repeated 3, 6 and 9 months after starting supplementation. Plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were compared before and after supplementation.

Eligibility criteria: Inclusion Criteria:

* HIV-infection
* 6 to 60 months of age
* Not receiving antiretroviral therapy
* Cared for as outpatients at Grey's Hospital

Exclusion Criteria:

* Receiving antiretroviral therapy

Primary outcomes:
measure: mean difference in log10 HIV-1 viral load at each visit
Secondary outcomes:
measure: mean difference in percentage of CD4+ T-cells at each visit
measure: number of illness visits
Other outcomes:
Locations:
city: Pietermaritzburg
country: South Africa
facility: Grey's Hospital
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: William J Moss, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Robert E Black, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Nelson R Mandela School of Medicine, University of KwaZulu-Natal
name: Raziya Bobat, MBChB, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Doris Duke Medical Research Institute, University of KwaZulu-Natal
name: Hoosen Coovadia, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06517147: Cooling Via Cryogenx Body Cooling Device
Official title: Efficacy of Post Exercise Heat Stress Cooling Via Cyrogenx Body Cooling Device
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Body Temperature Changes
Lead sponsor: Brunel University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this project is to test the rate of cooling following exercise in the heat utilising the CRYOGENX Cryosuit device i) against passive cooling, and ii) to quantify the rate of cooling and compare this rate with established cooling intervention thresholds i.e. -0.11 to 0.15°C.min-1. As this project is to determine the efficacy of the intervention in populations equivalent to sporting and military personnel, these aims will be tested in young (18-40 year old) healthy male and female participants whom participate in regular physical activity. As a commercially funded project, the experimental design implemented will closely replicate that of the independent investigation into the efficacy of the CAERvest® device.


Eligibility criteria: The inclusion criteria are:

Aged 18 - 40 years Free from known injury, illness and disease and regular use of medications other than oral contraceptives Undertake exercise training \>3 times per week for \~30 minutes per session

The exclusion criteria are:

Pregnant Previous history of neuromuscular fatigue Previous history of heat intolerance

Primary outcomes:
measure: Core (rectal) temperature
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04866147: Prediction of Chronic Postsurgical Pain in Adults
Official title: Prediction Model Development for Chronic Postsurgical Pain in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Postsurgical Pain
Acute Post Operative Pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 1522
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: Adult patients who undergo surgery meeting inclusion and exclusion criteria

Brief summary: This research will be a prospective single-centre observational cohort study in Denmark spanning approximately one year. The objective of this study is to develop a clinically applicable and generalizable prediction model for postsurgical pain in adults.


Eligibility criteria: Inclusion Criteria:

* Consenting Danish-speaking adults aged 18 years and older
* Patients who undergo common inpatient or outpatient surgical procedures

Exclusion Criteria:

* Patients with cognitive impairment
* Patients who refuse or unable to provide informed consent
* Patients who undergo re-operation within 3 months of their initial surgery

Primary outcomes:
measure: Chronic post surgical pain
timeFrame: 3 months post surgery
Secondary outcomes:
measure: Acute post surgical pain
timeFrame: First 3 hours after surgery
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Lone Nikolajsen, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02610647: Functional Significance of Complexity Measures in the Sensory-motor Behavior
Official title: Functional Significance of Complexity Measures in the Sensory-motor Behavior: Are There Potential Clinical Applications?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this study is to compare between groups the level of complexity of the estimated sensorimotor performance through multi-fractal (minmaxMF-DFA) exponents.

Detailed description: The secondary objectives of this study are to compare the level of complexity of the estimated sensorimotor performance using the(A) mono-fractal exhibitors (the αDFA values) and the (B) coefficient of variation (CV) between groups.

Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The subject does not practice music intensively (\<1h / day on average)

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or under guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The subject regularly practices music
* The subject is suffering from a neurodegenerative disease of the central or peripheral nervous system which may affect the sensorimotor control of rhythmic movements of the upper limb
* The subject has had a recent trauma of the upper limb
* The subject is suffering from uncorrected visual and hearing impairment

Primary outcomes:
measure: minmaxMF-DFA value during the tapping test
timeFrame: Day 0
Secondary outcomes:
measure: Coefficient of variation
timeFrame: Day 0
measure: αDFA value during the tapping test
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Laboratoire Movement to Health (M2H), Euromov, Université Montpellier 1
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Kjerstin Torre, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04690647: The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
Official title: The Efficacy of Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block for Acute Paint Control After Elective Total Hip Replacement Using Postero-lateral Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Analgesia
Arthropathy of Hip
Lead sponsor: Saint Lucas Hospital, Poland
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Total hip replacement surgery is one of the most common orthopedic interventions. Proper anaesthesia and adequate analgesia is one of the key interests of attending anaesthetist. Recent studies show that ultrasound guided suprainguinal fascia iliaca compartment block may play a significant role in proper management of pain after these procedures. The aim of this study was to assess the clinical usefulness and compare different methods of anaesthesia for total hip replacement surgery via posterolateral approach.


Eligibility criteria: Inclusion Criteria:

* age 18-75 years old
* informed consent to participate in the study
* ASA score I-III
* BMI -19-30kg/m2
* qualified for total hip replacement
* no contraindication to used anesthesia and drugs

Exclusion Criteria:

* contraindications to spinal anesthesia and regional blocks
* previously coexisting chronic pain
* previously opioids intake
* BMI\>30kg/m2
* allergy to drugs using during study
* mental status preventing the usage of patient controlled analgesia pump

Primary outcomes:
measure: Opioid consumption [mg]
timeFrame: 48 hours
measure: Opioid related adverse effects
timeFrame: 48 hours
measure: Hospital stay [days]
timeFrame: 31 days
Secondary outcomes:
measure: Likert scale
timeFrame: 31 days
Other outcomes:
Locations:
city: Konskie
country: Poland
facility: Saint Lucas Hospital
state: Swietokrzyskie
Study officials:
affiliation: Head of the Department of Anesthesia and Intensive Care Unit, Saint Lucas Hospital, Konskie, Poland
name: Wojciech Gola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gola W, Bialka S, Owczarek AJ, Misiolek H. Effectiveness of Fascia Iliaca Compartment Block after Elective Total Hip Replacement: A Prospective, Randomized, Controlled Study. Int J Environ Res Public Health. 2021 May 4;18(9):4891. doi: 10.3390/ijerph18094891.
Clinical trial NCT00295347: Mineralocorticoid Receptor in the Treatment of Severe Depression
Official title: Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2006-02-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed research aims to compare the onset of action and the efficacy of fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in 65 inpatients with severe depression. The study will also explore the utility of the hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo during three years.


Eligibility criteria: Inclusion Criteria:

* Depressed male and female inpatients according to DSM-IV
* Age between 18 and 70 years
* Minimum of 17-items Hamilton Depression Score of 18
* Informed consent signed

Exclusion Criteria:

* Relevant medical or neurological disorders
* Pregnancy or unsure contraception
* Relevant psychiatric comorbidity
* Active alcohol or other substance abuse/dependance
* Contraindications to SSRI, fludrocortisone, or spironolactone
* Steroid medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Christian Otte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03440047: Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim
Official title: Minimal Risk Registry of Endoscopic Image and Pathology Correlation Using Fujifilm 7000 Blue Light Imaging System With 4 Light-emitting Diode (LED) Multi Light Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Intestinal Disorder
Keywords: endoscopic image
Fujifilm
Blue light imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Fujifilm Medical Systems USA, Inc.
First posted: 2018-02-20
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Registry of endoscopic image and pathology correlation of different pathological condition such as: inflammatory bowel disease, colon polyps
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if advanced endoscopic imaging may be helpful to accurately distinguish pathological tissue from normal tissue and guide therapy of endoscopically identified pathology.

Detailed description: In this registry, the Fujifilm 4-LED system, which is considered non significant risk, will be used for routine endoscopic procedures at Mayo Clinic Florida and Rochester. Where indicated and based on clinical standards of care, a biopsy or tissue removal will be performed. Immediately prior to tissue removal, a standard set of electronic images will be captured including white light, BLI, BLI-bright, LCI. Each image will be stored in high resolution lossless format and later correlated with the final clinical and histological diagnosis.

Eligibility criteria: Inclusion Criteria:

1. All patients age 18-100 undergoing planned upper or lower endoscopy at Mayo Clinic Rochester
2. Informed Consent

Exclusion Criteria:

1. Patient unwilling to provide informed consent

Primary outcomes:
measure: Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis
timeFrame: Approximately one year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nayantara Coelho-Prabhu, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00542347: Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole
Official title: Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastric Acid
Keywords: gastric acid
proton pump inhibitors
omeprazole
esomeprazole
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2007-10-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Proton pump inhibitors (PPI) are used to decrease stomach acid secretion. A generic form of omeprazole, one of the PPIs, is on the market. With cheaper than brand name PPIs, it is unclear whether generic omeprazole is as effective clinically. This study compares generic omeprazole with half-dose esomeprazole, the strongest brand name PPI. The half-dose esomeprazole is in fact cheaper than generic omeprazole. Healthy volunteers will take each medication in turn for 7 days and their stomach acid will be measured while taking each medication. We hypothesize that half-dose esomeprazole is better at suppressing stomach acid than generic omeprazole.


Eligibility criteria: Inclusion Criteria:

* healthy, non-smoking volunteers older than 18 years of age

Exclusion Criteria:

* history of gastrointestinal disease
* known infection
* previous eradication of Helicobacter pylori
* any prescription or over the counter antacid medication
* pregnant and lactating women

Primary outcomes:
measure: Median intragastric pH and percentage of time that intragastric pH is above 4
timeFrame: 24 hours
Secondary outcomes:
measure: Nocturnal acid breakthrough, defined as at least 60 continuous minutes of intragastric pH below 4 occurring between 10pm and 6 am and adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University, Hotel Dieu Hospital
name: William G Paterson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu Hospital
name: Adriana Lazarescu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02803047: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment - Darkening Dose (MPPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00416247: Effect of Hypnosis on Motor Cortex Excitability
Official title: Effect of Hypnosis on Motor Cortex Excitability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Hypnosis
TMS
Cortical excitability
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is intended to investigate neurophysiological mechanisms of hypnosis using transcranial magnetic stimulation (TMS) and assessment of motor cortex excitability in healthy volunteers under hypnosis.


Eligibility criteria: Inclusion Criteria: .

1. Healthy volunteers aged 20 to 45 years.
2. Hypnotisability above 14 as measured by the Tellegan absorption scale.

Exclusion Criteria:

1. Psychiatric diagnosis in axis I or axis II;
2. Documented history of head injury or seizure disorder;
3. Evidence of a disorder which could affect peripheral and central conduction such as multiple sclerosis, motor neuron disease, carpal tunnel syndrome, cervical spondylosis, diabetic neuropathy.
4. Any other contraindication to TMS as specified in the safety guidelines for rTMS (Wassermann, 1998) such as cardiac pacemakers or metallic deep brain electrodes.
5. Chronic pharmacological treatment.

Primary outcomes:
measure: Cortical Excitability
timeFrame: Before and after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Ehud Klein, MD
role: PRINCIPAL_INVESTIGATOR
References: