louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01803360: Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
Official title: A Randomized, Double-blind, Placebo Controlled Trial to Assess the Efficacy of Neridronate 100 mg -4 i.v. Infusions- in Patients With Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 60
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: The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of knee Osteoarthritis (ACR criteria)
* Radiographic diagnosis of knee Osteoarthritis (Kellgren/Lawrence scale \>=2)
* \>4 weeks but \<3 months pain, reported as \>30 mm on a 100 mm VAS scale
* bone marrow oedema of the affected knee on magnetic resonance

Exclusion Criteria:

* inflammatory arthritis
* aseptic osteonecrosis of the knee
* previous or current treatment with Bisphosphonates
* serum calcium or creatinine abnormalities

Primary outcomes:
measure: knee pain reduction
timeFrame: 60 days
Secondary outcomes:
measure: Bone marrow lesions reduction
timeFrame: 60 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Ortopedico Gaetano Pini
state: MI
Study officials:
References:
citation: Varenna M, Zucchi F, Failoni S, Becciolini A, Berruto M. Intravenous neridronate in the treatment of acute painful knee osteoarthritis: a randomized controlled study. Rheumatology (Oxford). 2015 Oct;54(10):1826-32. doi: 10.1093/rheumatology/kev123. Epub 2015 May 20.
Clinical trial NCT00789360: Staccato Loxapine Pulmonary Safety in Healthy Volunteers
Official title: Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Detailed description: The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* nonsmoker subjects in good general health with normal spirometry at screening AND baseline

Exclusion Criteria:

* history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use

Primary outcomes:
measure: The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry
timeFrame: 17 post-treatment time points (15 min to 32 hr)
Secondary outcomes:
measure: The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry
timeFrame: 17 post-treatment time points (15 min to 32 hr)
Other outcomes:
Locations:
city: North Dartmouth
country: United States
facility: Northeast Medical Research
state: Massachusetts
Study officials:
affiliation: Northeast Medical Research, North Dartmouth, MA
name: David S. Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06040060: Ketamine Effects as Preemptive Analgesia
Official title: Effects of Ketamine 0.5 Mg/Kgbw Administration as Preemptive Analgesia on Analgesia Duration and the Need for Fentanyl Following Hysterectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain, Postoperative
Keywords: Ketamine
Preemptive Analgesia
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized controlled trial is to compare the effect of preemptive ketamine administration to placebo administration in patients underwent hysterectomy surgery. The main questions it aims to answer are:

1. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the duration of analgesia after hysterectomy surgery
2. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the need for fentanyl after hysterectomy surgery


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-50 years.
2. ASA I and II physical status (American Society of Anesthesiologists).

Exclusion Criteria:

1. The patient is not willing to be included as a research subject
2. The patient takes anti-pain medication before surgery
3. History of allergies to the drugs to be used
4. History of chronic pain

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: 24 hours post operative
measure: Total need for post-operative analgesic rescue
timeFrame: 24 hours post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Universitas Padjadjaran
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Iwan Fuadi, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Ardi Zulfariansyah, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Jacklin E Mokoginta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00079560: Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS
Official title: THC and Marijuana--Effects in Individuals With HIV/AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: HIV
Marijuana
Marinol
Oral THC
Appetite
Complementary Therapies
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are used to increase appetite, food intake, and weight in patients with HIV who experience unintended weight loss. This study will compare the effects of MJ and Marinol use in marijuana smokers who are HIV infected.

Detailed description: Little is known about the efficacy and tolerability of oral THC versus smoked MJ in a clinically relevant population. Additionally, it is not clear how THC's effects vary as a function of the duration of treatment or the patient's current patterns of smoked MJ use. This study directly compares 3 doses of smoked marijuana and 3 doses of Marinol across a range of behavioral measures in HIV infected marijuana smokers.

Outcome measures will include analysis of food intake, body composition, mood, physical symptoms (e.g., nausea, stomach pain), psychomotor task performance, and sleep.

Eligibility criteria: Inclusion Criteria

* HIV infected
* Smoke marijuana
* Taking HIV medications

Exclusion criteria

* Naive marijuana smokers
* People with history of respiratory/pulmonary disease

Primary outcomes:
measure: daily caloric intake
timeFrame: daily measure of colories
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Margaret Haney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03447860: Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)
Official title: Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC): A Randomized Controlled Trial on the Effectiveness of a Mindfulness Based Caregiver Multicomponent Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Salem Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: VA Boston Healthcare System
name: Virginia Polytechnic Institute and State University
name: United States Department of Defense
First posted: 2018-02-27
Enrollment: 142
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Primary objective of the study is to evaluate the effectiveness of mindfulness based caregiver intervention, Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC) compared to an established cognitive behavior therapy based dementia caregiver intervention, Resources for Enhancing Alzheimer's Caregiver Health (REACH) in improving caregiver burden and quality of life of care recipient.

Detailed description: The study is a randomized controlled trial comparing a mindfulness-enhanced evidence-based caregiver skill-building intervention (PAACC) to REACH-VA to reduce caregiver burden and increase quality of life of the care recipient. For this, caregivers of persons with ADRD or TBI-AD who have moderate to severe burden will be randomly assigned to either receive PAACC or receive REACH-VA. Both the interventions will include 4 biweekly sessions delivered by trained interventionists, followed by an outcome testing session after the intervention. Outcomes of caregiver stress, health and well being will be assessed at baseline and at the end of the intervention.

Eligibility criteria: Inclusion Criteria:

* Caregivers will include family members living with the individual diagnosed with Alzheimer's Disease( AD) or Alzheimer's disease related dementia(ADRD) or Traumatic Brain Injury -AD(TBI-AD) with moderate to severe caregiver burden .
* Care recipients with diagnosis of Diagnosis of AD or ADRD or TBI-related AD .

Exclusion Criteria:

* Care givers: Determined to be an imminent risk to self or others,the Care recipient currently resides in a nursing home or assisted living facilities, unable to provide their own consent to participate in the study , and active substance use disorder in the last 1yr.
* Care recipient: Determined to be an imminent risk to self or others, Caregiver is not interested in the study, unable to obtain informed consent from the Care recipient

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brockton
country: United States
facility: VA Boston Health Care system
state: Massachusetts
city: Salem
country: United States
facility: Salem VAMC
state: Virginia
Study officials:
affiliation: Salem VAMC
name: Mamta Sapra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02766660: Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy
Official title: Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Associated Ophthalmopathy
Keywords: Thyroid ophthalmopathy
optical coherence tomography
Lead sponsor: Neon Hospital
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2016-05-10
Enrollment: 102
Sex: ALL
Minimum age (years): 12
Maximum age (years): 73
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL), macula and optical disc parameters obtained by optical coherence tomography (OCT), and intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO) and healthy controls.

Detailed description: One hundred and thirty two eyes of 66 patients with TAO and 72 eyes of 36 healthy controls were included in the study. Proptosis level was determined by Hertel exophthalmometer. Optic disc, peripapillary retinal nerve fiber layer and macula parameters were measured by OCT. All measurements were compared between the patients and age and sex-matched healthy controls.

Eligibility criteria: Inclusion Criteria: Patient group consists the consecutive patients with thyroid associated ophthalmopathy consulted by endocrinology department.

The control group was chosen among healthy volunteers who have

* no eye pathology,
* 20/20 vision (corrected or uncorrected),
* age and sex-matched with the patient group.

Exclusion Criteria:

For both groups, those who had

* significant sight impairment,
* high myopia ( \< -5Diopters ),
* high hyperopia ( \> +3Diopters ),
* optic disc anomaly,
* vitreoretinal interface disease,
* vascular and degenerative retinal diseases,
* cornea or lens opacity, ocular surgery history,
* glaucoma,
* neurological diseases that can affect the visual field,
* history of trauma, amblyopia,
* diplopia,
* keratitis,
* history of topical or systemic steroid

Primary outcomes:
measure: Macular thickness
timeFrame: one year (between Jan 2012 and Jan 2013)
measure: Retinal nerve fiber layer thickness
timeFrame: one year (between Jan 2012 and Jan 2013)
Secondary outcomes:
measure: Optic disc parameters
timeFrame: one year (between Jan 2012 and Jan 2013)
Other outcomes:
Locations:
Study officials:
affiliation: Ondokuz Mayıs University
name: Nurşen ARITÜRK, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sayin O, Yeter V, Ariturk N. Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid-Associated Ophthalmopathy. J Ophthalmol. 2016;2016:9452687. doi: 10.1155/2016/9452687. Epub 2016 Jul 17.
Clinical trial NCT03390660: Trends in Breastfeeding Disparity in U.S. Infants by WIC Eligibility and Participation
Official title: Trends in Breastfeeding Disparity in U.S. Infants by WIC Eligibility and Participation: Evidence From NHANES 1999-2014
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Feeding
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 13771
Sex: ALL
Minimum age (years): 1
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A nationally representative sample surveyed in NHANES 1999-2014

Brief summary: This is a secondary data analysis study that uses nationally representative data to examine the trends in breastfeeding disparities between Women, Infants, and Children (WIC) program eligible children vs. non-eligible children and eligible participants vs. eligible non-participants.


Eligibility criteria: Inclusion Criteria:

* infants or children surveyed in NHANES 1999-2014 aged younger than 72 months

Exclusion Criteria:

* infants or children with missing information in breastfeeding, WIC participation, or other major socio-demographics, such as income

Primary outcomes:
measure: Everbreastfeeding
timeFrame: till age 5
measure: Breastfeeding at 6 months
timeFrame: till age 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06271694: Activity and Participation in Vestibular Disorders
Official title: Impairments and Personal Factors Associated with Activity and Participation in Vestibular Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Disorder
Keywords: Vestibular Rehabilitation
Activity and Participation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-02-22
Enrollment: 50
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
Primary purpose: OTHER

Brief summary: This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation.

Detailed description: Adults aged 18-years and older with symptomatic complaints of dizziness and/or imbalance and a medical diagnosis of unilateral vestibular hypofunction will be recruited at the time of their entry into vestibular rehabilitation. The investigators will analyze what factors (impairments and personal factors) are related to activity and participation in people with vestibular disorders and see if change in activity and participation is related to recovery from vestibulopathy.

Eligibility criteria: Inclusion Criteria:

- 18-years and older with symptomatic complaints of dizziness and/or imbalance and a medical diagnosis of unilateral vestibular hypofunction

Exclusion Criteria:

* 1. Cognition \<18 on Montreal Cognitive Assessment (MoCA)
* 2. Visual acuity worse than 20/40 with corrected lenses
* 3. Loss of protective distal sensation (defined as the inability to feel a 4.31 size monofilament on the plantar surface of the foot)
* 4. Inability to engage in community mobility

Primary outcomes:
measure: Late-life Function and Disability Instrument
timeFrame: 8-weeks
measure: Dizziness Handicap Inventory
timeFrame: 8-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC-Rehab Institute
state: Pennsylvania
Study officials:
affiliation: Assistant Professor
name: Brooke Klatt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03340194: Evaluation of Calcinosis in Systemic Sclerosis
Official title: Evaluation of Calcinosis Prevalence in Systemic Sclerosis : a Cross Sectional Study Evaluating Calcinosis Cutis Prevalence by Hand and Feet Radiographic Assessment in Systemic Sclerosis Patients and Study Their Correlation With Organ Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Keywords: Systemic sclerosis
Calcinosis cutis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Systemic sclerosis patient in the national reference center for scleroderma (Lille, France)

Brief summary: Systemic sclerosis is a rare pathology characterized by fibrosis and vascular lesion with skin, pulmonary, digestive and cardiac localisation. Calcinosis cutis is commonly described, but its prevalence and appear few documented in literature. Moreover, this studies used clinical observation to determine presence or absence of calcification, and rarely radiography, in particular for feet localisation. In the same way, skin calcification and organ injury association appear unclear. The aim of the study is firstly to determine prevalence of calcinosis cutis, with hand and feet radiography realisation in a cohort of systemic sclerosis patient. Secondly, will be determine the correlation between calcinosis and organ injury.


Eligibility criteria: Inclusion Criteria:

* Systemic sclerosis presenting ACR-EULAR 2013 criteria
* Given their consent
* Titulary of health insurance

Exclusion Criteria:

* Dermatomyositis overlap
* Pregnant or breastfeeding women
* Imprisoned person
* Refuse of consent

Primary outcomes:
measure: Calcinosis cutis prevalence by radiographic assessment
timeFrame: at inclusion ( baseline)
Secondary outcomes:
measure: Demographic data
timeFrame: at inclusion ( baseline)
measure: Rodnan score
timeFrame: at inclusion ( baseline)
measure: Visceral localisation evaluation (cardiac, pulmonary, digestive)
timeFrame: at inclusion ( baseline)
measure: EUSTAR score
timeFrame: at inclusion ( baseline)
measure: Medsger score
timeFrame: at inclusion ( baseline)
measure: Quality of life evaluation (HAQ modified questionary)
timeFrame: at inclusion ( baseline)
measure: Biologic vascular markers : VEGF, endothelin 1, endostatin and P/GF, (ELISA method)
timeFrame: at inclusion ( baseline)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Vincent SOBANSKI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01020994: Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema
Official title: Explorative, Double-blind, Randomized, Controlled Multi-center Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41003 Once Daily Versus LAS189962 and LAS189961 in the Treatment of Superficial Infected Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eczema
Keywords: Superficial infected eczema
Superinfected eczema
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2009-11-26
Enrollment: 150
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: The aim of the study is to determine the efficacy and safety of topical application of LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed super-infected or impetiginized eczema

Exclusion Criteria:

* Patients who have general signs of systemic infections like fever, malaise, lymphangitis or swollen lymph nodes and / or need systemic antibiotic treatment
* Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication
* Diagnose of the following disease:

  * Known active tuberculosis or any history of past tuberculosis of skin
  * Suspected or proven parasitic infection of the treatment site (e.g. scabies)
  * Psoriasis
  * Suspected or proven viral infection of skin (e.g. Herpes)
* Localization of the superficial infected eczema:

  * Palms of the hands
  * Sole of a foot
  * Face
* Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP

Primary outcomes:
measure: Combination of clinical and microbial treatment success
timeFrame: Day 14
Secondary outcomes:
measure: Safety:Physical examination at EoT, AEs/SAEs during the entire study
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Investigational Site
Study officials:
affiliation: Almirall Hermal GmbH
name: Christoph Willers, MD, MBA
role: STUDY_DIRECTOR
References: