louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05943548: Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
Official title: Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: Traditional Healer
Community Health
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Mbarara University of Science and Technology
First posted: 2023-07-13
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel arm cluster randomized trial will be used to compare the effectiveness of the intervention to the control.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to test a new approach to support people living with Human Immunodeficiency Virus (HIV) in Uganda. Traditional healers (TH) will be trained to provide counselling and testing for HIV, help patients start antiretroviral therapy quickly, and offer guidance on taking medications and staying in HIV care. This support will be given in addition to the regular care provided at clinics. The main goal of the study is to see if this new approach can help more people in rural areas achieve viral suppression.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years old
* reactive point-of-care (POC) oral swab rapid HIV self-test (ex. OraQuick© HIV1/2 antibody testing) at the TH location or previously diagnosed with HIV (verified by the HIV clinic), and CASE adherence index score ≤10
* baseline viral load measurement of \>200 copies/mL
* primary residence in Mbarara or Rwampara district
* agrees to study procedures, including that PLWH will go to one of the five pre-determined HIV clinics if they choose to receive HIV care, and in-person visits at baseline, 12- and 24-months with study nurse

Exclusion Criteria:

* Unwilling or unable to participate in study procedures or provide written informed consent

Primary outcomes:
measure: Viral Load Suppression in People Living with HIV (PLWH) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Linkage to HIV Care
timeFrame: 7 Days
measure: Antiretroviral Therapy (ART) Initiation
timeFrame: 7 days
measure: Antiretroviral Therapy (ART) Adherence
timeFrame: 12 months
measure: Retention in Care
timeFrame: 12 months
measure: Medical Outcomes Study-HIV Health Survey (MOS-HIV) Score at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: Weill Medical College of Cornell University
name: Radhika Sundararajan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02030548: Bleeding in Patients Undergoing CABG (Coronary Artery Bypass Graft) During Dual Antiplatelet Therapy
Official title: Bleeding in Patients Undergoing Urgent CABG During Dual Antiplatelet Therapy Including the New P2Y12 Receptor Inhibitors Prasugrel and Ticagrelor
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Coronary Syndrome
Keywords: CABG
dual antiplatelet therapy
aspirin
clopidogrel
prasugrel
ticagrelor
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients undergoing acute CABG with or without valve during dual antiplatelet therapy

Brief summary: The aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel, Ticagrelor)


Eligibility criteria: Inclusion Criteria:

consecutive patients undergoing acute CABG with or without valve replacement within 7 days after last intake of dual antiplatelet therapy

Exclusion Criteria:

concomitant oral anticoagulants dialysis surgery employing hypothermic cardiac arrest

Primary outcomes:
measure: calculated blood loss
timeFrame: until postoperative day 5
Secondary outcomes:
measure: mortality
timeFrame: from index surgery until one year after index surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Dept. of Anesthesiology and Intensive Care Medicine
state: Styria
Study officials:
affiliation: Dept. of Anesthesiology and Intensive Care Medicine, MUG
name: Elisabeth Mahla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348348: A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
Official title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the Treatment of Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bacterial Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 1161
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

Exclusion Criteria:

* Pregnant or nursing females.
* Use of any antibiotic within 72 hours of enrollment.
* Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
* Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.

Primary outcomes:
measure: Clinical Resolution
timeFrame: Day 5(+/- 1 day)
measure: Microbial Eradication
timeFrame: Day 5 (+/- 1 day)
Secondary outcomes:
measure: Clinical Resolution
timeFrame: Day 8 or Day 9
measure: Microbial Eradication
timeFrame: Day 8 or Day 9
Other outcomes:
Locations:
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Timothy Comstock, OD
role: STUDY_DIRECTOR
References:
citation: DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.
citation: Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.
Clinical trial NCT00194948: Treatment Choices for Improving Adherence and Outcome
Official title: Patient Preference in Primary Care Depression Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effectiveness of offering primary care patients their preferred treatment versus one that is less desirable in improving treatment adherence and outcome.

Detailed description: This study investigates whether offering primary care patients treatment that is congruent with their preferred first choice improves adherence and outcomes, in comparison to offering treatment that is not congruent with their preferred first choice. All subjects are offered a treatment with demonstrated efficacy, namely either the antidepressant medication escitalopram or Interpersonal Psychotherapy for 5 months. We hypothesize that patients who receive congruent treatment will be more likely to initiate treatment, adhere to treatment, and achieve depression remission.

Eligibility criteria: Inclusion Criteria:

* age 21-99
* English-speaking
* DSM-IV criteria for major depression

Exclusion Criteria:

* unable to give informed consent
* MMSE\<24
* DSM-IV diagnosis of bipolar disorder, psychotic disorder, current alcohol or substance abuse
* active suicide ideation
* aphasia
* acute or severe medical illness
* currently receiving either antidepressant medication or psychotherapy

Primary outcomes:
measure: treatment initiation
measure: treatment adherence
Secondary outcomes:
measure: depressive symptomatology
Other outcomes:
Locations:
city: New York
country: United States
facility: Cornell Internal Medicine Associates
state: New York
city: White Plains
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Patrick J Raue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06303648: A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
Official title: A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Transcend Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1.
Primary purpose: TREATMENT

Brief summary: This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.


Eligibility criteria: Key Inclusion Criteria:

* Healthy adult male or female aged 25 to 55 inclusive
* Normal resting ECG
* Normal hematologic and hepatic function
* Normal renal function

Key Exclusion Criteria:

* Vital sign abnormalities
* Positive urine drug screen at screening and / or Day -1
* Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders

Primary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration for methylone
timeFrame: 48 hours following the dose
measure: AUC: Area under the plasma concentration-time curve for methylone
timeFrame: 48 hours following the dose
Secondary outcomes:
measure: Incidence and frequency of adverse events
timeFrame: 10 days after the dose
measure: Change overtime in Visual Analog Scales
timeFrame: 12 hours after the dose
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
References:
Clinical trial NCT02674048: Metvix Daylight PDT in Actinic Keratosis
Official title: Observational Study to Evaluate Clinical Practice and Satisfaction With Metvix® Daylight Photodynamic Therapy (PDT) in the Treatment of Mild and/or Moderate Actinic Keratosis of the Face and/or the Scalp
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratosis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2016-02-04
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with mild to moderate Actinic Keratosis on the face or scalpe

Brief summary: Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate actinic keratosis of the face/scalp and to assess physician and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patients to whom Metvix® Daylight-PDT has already been prescribed by their physician, according to the local label;

Primary outcomes:
measure: Percentage of physician satisfaction assessed on a 4-point scale from very satisfied to not satisfied with the question "Overall are you satisfied with Metvix DL-PDT?"
timeFrame: 3 months
measure: Percentage of patient satisfisfaction assessed on a 4-point scale from very satisfied to not satisfied with the question "Overall, how satisfied are you with this treatment?".
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: See Jo-Ann
state: New South Wales
city: Pontoise
country: France
facility: France
city: L'Aquila
country: Italy
facility: Italy
city: Alkmaar
country: Netherlands
facility: Alkmaar
city: Madrid
country: Spain
facility: Madrid
city: Bern
country: Switzerland
facility: Bern
city: Manchester
country: United Kingdom
facility: Manchester
Study officials:
References:
citation: See JA, Gebauer K, Wu JK, Manoharan S, Kerrouche N, Sullivan J. High Patient Satisfaction with Daylight-Activated Methyl Aminolevulinate Cream in the Treatment of Multiple Actinic Keratoses: Results of an Observational Study in Australia. Dermatol Ther (Heidelb). 2017 Dec;7(4):525-533. doi: 10.1007/s13555-017-0199-9. Epub 2017 Sep 13.
Clinical trial NCT03504748: Deep rTMS in Parkinson Disease Pain Syndromes
Official title: Deep rTMS in Parkinson Disease Pain Syndromes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Parkinson Disease
Keywords: deep repetitive transcranial magnetic stimulation
chronic pain
parkinson
treatment
non-motor symptom
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain is the most prevalent non-motor symptom in Parkinson disease, and the motor improvement not always is related to the pain improvement with the medication treatment. By this, we are testing a non-invasive method called transcranial magnetic stimulation as an alternative to treat pain related to Parkinson disease. This technique can lead to either inhibitory or excitatory effects in brain circuits depending on stimulation parameters, and is known to provide analgesic effects.


Eligibility criteria: Inclusion Criteria:

* Parkinson disease
* Signed term of informed consent
* Parkinsson disease related pain

Exclusion Criteria:

* Trauma of Skull, epilepsy don't treated
* Use of medications decrease the seizure threshold
* Patients in use of drugs, how cocaine and alcohol
* neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
* Pregnant or lacting women
* Moderate or severe cognitive impairment

Primary outcomes:
measure: Change in baseline of Pain
timeFrame: base line (moment of inclusion), day 15th, day 45th and in the last day of the sessions of rTMS (4X in two months)
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
state: SP
Study officials:
References:
Clinical trial NCT00323648: Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis
Official title: Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncomplicated Acute Cholecystitis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Each patient is preoperatively treated once profylactic with intraveneous antibiotics. Postoperatively, one group will be treated with intraveneous antibiotics during 5 days. The other group will receive no antibiotics.


Eligibility criteria: Inclusion Criteria:

* Uncomplicated acute cholecystitis \< 5 days(confirmed by echography and blood sample)
* \> 18 years old

Exclusion Criteria:

-

Primary outcomes:
measure: Postoperative complications (abces, infection of the wound)
timeFrame: day 2, day of discharge and dag 21
Secondary outcomes:
measure: Duration of hospitalisation
timeFrame: Day O to day of discharge
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05760248: Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity
Official title: A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Subcutaneous Fat Disorder
Keywords: Right and Left Flank Fat
Lead sponsor: 10xBio, LLC
Sponsor class: INDUSTRY
Collaborators: name: Therapeutics, Inc.
First posted: 2023-03-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active drug 6% vs Placebo
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity.

The main question it aims to answer is:

•How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo?

Participants will be:

* Be given injections every month for 5 months over the right and left flanks.
* Be asked to be seen in the clinic for 13 visits and 3 phone call visits during a duration of 1 year.

Detailed description: Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.

Eligibility criteria: Inclusion Criteria:

* Subject is a male or non-pregnant female 18 to 55 years old.
* Subject has provided written informed consent.
* Subject has qualifying fat evaluation and skin laxity scores on each right and left flanks.
* Subject has had a stable body weight for the past 6 months prior to starting study.
* Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.

Exclusion Criteria:

* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject has loose skin in the right and left flank areas, unrepaired abdominal injury or defect, scars, tattoos, or other features that may interfere with evaluation of localized fat, in the opinion of the investigator.
* Subject has any medical condition or taking medications that affects clotting and/or platelet function
* Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.

Primary outcomes:
measure: Volumetric measurements
timeFrame: 24 weeks after final injection treatment
measure: Flank Skin Laxity Scale (FSLS)
timeFrame: 24 weeks after final injection treatment
measure: Clinician Global Impression of Change (CGIC)
timeFrame: 24 weeks after final injection treatment
measure: Patient Global Impression of Change (PGIC)
timeFrame: 24 weeks after final injection treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rolling Meadows
country: United States
facility: Site #01
state: Illinois
city: New Brighton
country: United States
facility: Site #02
state: Minnesota
Study officials:
affiliation: 10xBio, LLC
name: John Dobak, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06386848: Strategy to Adapt Botulinum Toxin Doses in Dystonia
Official title: Strategy to Adapt Botulinum Toxin Doses in Dystonia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dystonia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years diagnosed with dystonia

Brief summary: The study is designed to observ and collect the doses of botulinum toxin injected in dystonia in different centres to compare the initial dose and the dose recommended.

We we ll study the increase of the dose injected over the time, the side effects...

The hypothesis is that we inject smaller doses than we could regarding the recommandations


Eligibility criteria: Inclusion Criteria:

* patients over 18 years old followed for dystonia and treated with botulinum toxin

Exclusion Criteria:

* first dose of botulinum toxin not available

Primary outcomes:
measure: First dose of botulinum toxin injected, U
timeFrame: 30 years
Secondary outcomes:
measure: Effective dose of botulinum toxin
timeFrame: 30 years
measure: Side effects
timeFrame: 30 years
Other outcomes:
Locations:
Study officials:
References: