louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00207168: To Assess Compliance With a Once-daily Regimen of Lamivudine, Efavirenz and Didanosine
Official title: A Randomized, Multi-center, Open Label Study in Well Controlled Treatment-experienced HIV- Infected Patients to Assess Compliance With a Once-daily Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: AIDS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
name: Dohme Australia
First posted: 2005-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess compliance of once daily dosing to assess their benefits in terms of potency and safety as well as their impact on adherence and quality of life.


Eligibility criteria: Inclusion Criteria:

* 18 or older, required lab results, currently taking no more than two of the proposed once daily arm medications with medications administered twice daily and women of child bearing potential.

Exclusion Criteria:

* virological failure, serious medical condition, known toxicities to any of the once daily arm medications, lab abnormalities, women who are pregnant/breastfeeding

Primary outcomes:
measure: To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomized to receive either a once daily 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing.
Secondary outcomes:
measure: To demonstrate that once daily therapy is not-inferioir to continued multiple dosing in terms of proportion of patients with treatment failure.
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01330368: Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
Official title: Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
SLE
Lupus
children with SLE
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 control patients (124 controls participated in unique protocol ID: 2007-10-5528 data will be used for this study, we will be trying to recruit about 76 control patients for this study) and 30 study patients with SLE

Brief summary: The purpose of this study is to compare healthy children to children who have systemic lupus erythematosus (SLE). SLE is a childhood disease that has high risk for low bone mass and vertebral compression fractures.

Detailed description: The purpose of this research study is to measure bone mass in children with SLE using different measurement techniques. Children with chronic illnesses are at risk of bone fragility. This is important because bone fragility can result in childhood fractures especially children with SLE. Therefore better diagnosis technique can lead to better management of bone health.

Eligibility criteria: Inclusion Criteria:

* For SLE subjects: Subjects age 5-21 drawn from rheumatology clinic at Children's Hospital of Philadelphia diagnosed with SLE for at least 1 month. Also subjects with no known vertebral compression fracture of L2.
* For Control subjects: Subjects age 5-21. Controls will be a 50% male/female.

Exclusion Criteria:

* For SLE subjects: Subjects with SLE will be excluded if they have conditions or drug exposure unrelated to SLE and known to impact growth or bone health.
* For Control subjects: Chronic disease or syndrome known to affect growth or bone health, prematurity (\<37 weeks gestation), or use of any medication known to affect growth.

Primary outcomes:
measure: Age and sex specific z-scores for lumbar spine (L2) volumetric bone mineral density (BMD) (trabecular and total) and vertebral volume.
timeFrame: 2 years
Secondary outcomes:
measure: Mean lumbar spine stiffness and strength in children with SLE and healthy controls correlation between standard and low dose lumbar spine.
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jon Burnham, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02106468: The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus
Official title: The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus and Improvement of Quality of Life: A Randomized, Double Blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Lichen Planus
Keywords: Oral Lichen Planus
Corticosteroid
Omega -3
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of OLP (Presence of painful and atrophic-erosive oral Lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines).
2. Age between 30-60 years
3. Ability to complete the present clinical trial.

Exclusion Criteria:

1. Pregnant or breast feeding women (pregnancy test for women of child bearing age).
2. Lichenoid reactions caused by certain drugs or dental amalgam.
3. Therapy for oral lichen planus (OLP) in the 6 months prior to the study.
4. Patient doesn't have hepatitis C \[after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2
5. Presence of candidiasis before treatment.
6. Patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dL before initiating steroid therapy were excluded.
7. Hypertensive patients
8. Contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations).

Primary outcomes:
measure: Improve quality of the life (Oral Health Impact Profile)
timeFrame: 6 months
Secondary outcomes:
measure: Size and types (atrophic/erosive) of the lesions
timeFrame: 6 months
measure: Pain score (Visual analogue scale (VAS)),
timeFrame: 6 months
measure: Recurrence of disease
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October 6 University
Study officials:
affiliation: October 6 University
name: Enas Elgendy, ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06960668: Nature for Body Image
Official title: Look at the Bright (Nature) Side: Improving Body Image and Associated Protective Factors and Reducing Body Image Threats With the Nature for Body Image (NBI) Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Image
Eating Behaviors
Self-Compassion
Interoception
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nature exposure has been found to be particularly beneficial for body image, as recent studies have identified a positive association between time spent in nature and positive body image. Positive body image, defined as the ability to accept and respect one's body, has been linked to greater life satisfaction and engagement in healthy behaviors. Conversely, negative body image is recognized as a public health concern due to its detrimental effects on both physical and mental health. It has been associated with symptoms of Body Image Disorders (BIDs), including Eating Disorders (EDs) and Body Dysmorphic Disorder (BDD).

The Nature for Body Image (NBI) project aimed to examine the impact of a structured nature exposure intervention on improving body image among young women aged 18-35 years.


Eligibility criteria: Inclusion Criteria:

* Females
* Age 18-35 years old

Exclusion Criteria:

* Full-blown body image disorder

Primary outcomes:
measure: Negative Body Image
timeFrame: 5 weeks
measure: Body Appreciation
timeFrame: 5 weeks
measure: Functionality appreciation
timeFrame: 5 weeks
Secondary outcomes:
measure: Dysfunctional Eating Behaviours and Risk of Developing Eating Disorders
timeFrame: 5 weeks
measure: Functional Eating Behaviors
timeFrame: 5 weeks
measure: Embodiment
timeFrame: 5 weeks
measure: Interoceptive Awareness
timeFrame: 5 weeks
measure: Self-compassion
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Department of General Psychology, University of Padova
Study officials:
References:
Clinical trial NCT06343168: Prevalence of Frailty and Associated Factors in Coronary Artery Bypass Patients
Official title: Prevalence of Frailty and Associated Factors in Coronary Artery Bypass Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: coronary artery bypass grafting patients

Brief summary: This study aimed to determine the prevalence of and factors affecting frailty in patients with coronary artery bypass graft.

The main question it aims to answer are:

What are the prevalence of and factors affecting frailty in patients with coronary artery bypass graft Type of study: descriptive cross-sectional study Participant population: coronary artery bypass grafting patients


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* planned CABG surgery
* volunteer to participate in the study

Exclusion Criteria:

* limb amputations
* stroke-related sequela
* hearing problems
* clinically unstable

Primary outcomes:
measure: Prevalence of frailty
timeFrame: Preoperative
Secondary outcomes:
measure: Activities of Daily Living
timeFrame: Preoperative
measure: Nutritional Assessment
timeFrame: Preoperative
measure: Comorbidity
timeFrame: Preoperative
measure: Cognitive Assessment
timeFrame: Preoperative
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University
state: Center
Study officials:
References:
Clinical trial NCT03342768: An RCT of a Smartphone-based TID Programme
Official title: A Smartphone Messaging Programme for Tobacco Industry Denormalisation - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Industry Denormalisation Beliefs
Tobacco-related Communications
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 163
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims to test the effect a smartphone-based intervention on primary school students and their parents' attitudes towards tobacco industry and their tobacco-related communications.


Eligibility criteria: Inclusion Criteria:

* Parents and children should all understand Chinese.
* Parents should have a smartphone and use WhatsApp (a smartphone-based app)

Exclusion Criteria:

* n/a

Primary outcomes:
measure: TID beliefs in parents
timeFrame: 1 month
measure: TID beliefs in children
timeFrame: 1 month
Secondary outcomes:
measure: Tobacco related communication reported by parents
timeFrame: 1 month
measure: Sugar sweetened beverage (SSB) related communication reported by parents
timeFrame: 1 month
measure: Tobacco related communication reported by children
timeFrame: 1 month
measure: SSB related communication reported by children
timeFrame: 1 month
measure: Intention to smoke in children
timeFrame: 1 month
measure: Home exposure to secondhand smoke in children reported by children
timeFrame: 1 month
measure: Home exposure to secondhand smoke in children reported by parents
timeFrame: 1 month
measure: Parents' support for tobacco control
timeFrame: 1 month
measure: Negative attitude towards smoking in parents
timeFrame: 1 month
measure: Negative attitude towards smoking in children
timeFrame: 1 month
measure: Past 7-day consumption of SSB and water in children reported by children
timeFrame: 1 month
measure: Past 7-day consumption of SSB and water in children reported by parents
timeFrame: 1 month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Local primary schools
Study officials:
affiliation: The University of Hong Kong
name: Sai Yin Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02768168: The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation
Official title: The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect
Keywords: Dezocine
Dexamethasone 21-phosphate
Pain
Pruritus
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 80
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 purpose of this study is to investigate the efficacy of dezocine pretreatment on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

Detailed description: Dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. The major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. Some patients undergo spontaneous remission, while others develop into severe pain or pruritus. Dezocine, a new synthetic opiate agonist-antagonist, has been used for the treatment of pain and pruritus, but its role in relieving dexamethasone induced perineal irritation has not been studied yet. The aim of this study was to investigate the efficacy of dezocine pretreatment on dexamethasone induced perineal irritation.

Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years
* ASA physical status I-II
* BMI 18-24.5 kg/m2

Exclusion Criteria:

* On regular use of analgesic
* Contraindication or allergy to steroid or dezocine
* Drug or alcohol abuse
* Diagnosed with paresthesia or mental diseases
* Communication disorders
* Pregnancy or nursing

Primary outcomes:
measure: The occurrence of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)
timeFrame: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate
Secondary outcomes:
measure: The severity of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)
timeFrame: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate
Other outcomes:
measure: The duration of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)
timeFrame: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Junwei Zheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00742768: Comparison of Absorption of Vitamin K2
Official title: Comparison of Absorption of Vitamin K2 Human Study Gelpell
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: absorption
encapsulation
menaquinone
Bio-availability
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: VitaK
First posted: 2008-08-28
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.

This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women between 20 and 30 years old
* Subjects of normal body weight and height according to BMI \< 30
* Subjects of Caucasian race
* Subject has given written consent to take part in the study

Exclusion Criteria:

* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects presenting chronic degenerative and/or inflammatory disease
* Subjects receiving corticoϊd treatment
* Subjects using oral anticoagulants
* Subject with (a history of) soy allergy
* Subjects using vitamin K containing multivitamins or vitamin K supplements
* Subjects with anaemia or subjects who recently donate blood.

Primary outcomes:
measure: The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure.
timeFrame: 4 weeks
Secondary outcomes:
measure: The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: VitaK BV / Maastricht University
Study officials:
affiliation: Maastricht University, VitaK BV
name: Cees Vermeer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00729768: A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation
Official title: A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen in De Novo Renal Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Kidney Transplantation
Keywords: Renal transplant
Raptiva
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.


Eligibility criteria: Key Inclusion Criteria:

* Have signed the informed consent form and the HIPAA patient information form (United States only)
* Are ≥ 18 years of age
* Are a transplant recipient of at least one HLA-mismatch kidney
* For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method

Key Exclusion Criteria:

* Have a history of previous renal transplant
* Have had a PRA \> 25% at any time
* Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ
* Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum
* Have had previous treatment with efalizumab
* Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer
* Have a known contraindication to efalizumab
* Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies
* Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab
* Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate

Primary outcomes:
measure: Subject and renal allograft survival
timeFrame: 52 weeks
Secondary outcomes:
measure: Glomerular filtration rate
timeFrame: 12 and 52 weeks
measure: Change in glomerular filtration rate
timeFrame: 12 weeks to 52 weeks
measure: Transplant renal biopsies
timeFrame: 52 weeks
measure: Change in metabolic/cardiovascular risk factors
timeFrame: 24 weeks and 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: