louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02105064: Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Obsessive-Compulsive Symptoms
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-04-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Schizophrenia (DSM-IV-TR)
* YBOCS ≥ 16

Exclusion Criteria:

* Mental Retardation
* Substance abuse
* Any contraindication to rTMS

Primary outcomes:
measure: Change of Obsessive Compulsive symptoms (using Yale-Brown Obsessive Compulsive Scale - Y-BOCS)
timeFrame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Secondary outcomes:
measure: Change of Psychotic Symptoms (using Brief Psychiatric Rating Scale - BPRS)
timeFrame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
measure: Change of Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: Baseline, after 20 rTMS sessions (an expected average of 4 weeks), and 4 weeks after end of treatment
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT02803164: Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds
Official title: A Pilot Study to Evaluate the Efficacy of Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Chest Wounds
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds (OCW) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management.


Eligibility criteria: Inclusion Criteria:

* Subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection.

Exclusion Criteria:

* Patent bronchopleural fistulas. Severe respiratory failure requiring mechanical ventilation at the time of first consultation.
* Proven or suspected malignancy in the wound. Coagulopathy due to medical or pharmacologic reasons. Dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time.

Allergy to acrylic products.

Primary outcomes:
measure: Duration of Negative Pressure Wound Therapy (NWPT)
timeFrame: 12 month follow up
Secondary outcomes:
measure: Wound Closure
timeFrame: 12 months
measure: Length of Hospital Stay
timeFrame: 12 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mauricia Buchanan
state: Florida
Study officials:
References:
Clinical trial NCT01830764: Open-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers
Official title: An Open-label Safety and Tolerability Study of LTS 0.3% With Red Light Applied to the Backs of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers.

Detailed description: This is an open-label, safety study in healthy volunteers. Two cohorts, of 6 subjects each, will be enrolled (total subjects = 12). Each subject will have test areas identified on the back and receive a single LTS, vehicle solution and red light (PDT) applied to the test areas on the back. Subjects will be followed for safety at study visits occurring on Day 1 (baseline and treatment), Day 2, and Day 7.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults 18 years of age or older
2. Fitzpatrick skin types I-IV

Exclusion Criteria:

1. Current pregnancy or lactation.
2. Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne.
3. Poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition
4. Subjects who have used any agents known to produce significant photosensitivity reactions (tetracyclines, phenothiazines, trimethoprim, etc.) within 2 weeks of Day 1 or 5 half-lives, whichever is longer.
5. Subjects who have used any medicated topical therapy on the back within 3 days of Day 1.
6. Chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (NSAID), or an anticoagulant regimen such as warfarin (Coumadin).
7. Abnormal findings on screening ECG deemed clinically significant by the Investigator.
8. Active participation in an experimental therapy study or experimental therapy within 30 days of Day 1.
9. Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
10. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.

Primary outcomes:
measure: Adverse Events
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research Inc (Research Clinics Division)
state: New Jersey
Study officials:
affiliation: TKL Research Inc (Research Clinics Division)
name: Jonathan S Dosik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00797264: Ketamine Associated With Morphine PCA After Total Hip Arthroplasty
Official title: Impact of the Route of Administration of Ketamine Associated With Morphine PCA on Analgesia After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: Ketamine
Morphine
PCA
Hyperalgesia
Nor-ketamine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 18
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: Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine administrated separately via a continuous infusion, could induced a better analgesic effect.

We will perform a randomised double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion.

Detailed description: Double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion

Eligibility criteria: Inclusion Criteria:

* total hip arthroplasty

Exclusion Criteria:

* pre operative opioid administration

Primary outcomes:
measure: Morphine consumption in PACU and in hospitalisation room
timeFrame: at 24 and 48 hours
Secondary outcomes:
measure: Postoperative Visual Analogic Score of pain
timeFrame: in Recovery Room, at 24 and 48 hours, in the ward
measure: Postoperative Measure of mechanical hyperalgesia by Von Frey filament device
timeFrame: 24 and 48 hours in the ward
measure: Postoperative measure Ketamine and Nor-Ketamine blood levels
timeFrame: at 24 and 48 hours in the ward
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: Service d'anesthesie-reanimation - Hôpital Bicêtre
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre
name: Philippe SITBON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05564364: The Effect of Bike Exercise on Joint and Muscles
Official title: The Effect of Two Different Bikes Exercises on Healthy Knee Joint Cartilage and Lower
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Joint
Exercise
Ultrasound
Bicycle
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The design of our study is a prospective. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the effects of two different bike exercises on knee joint and lower extremity muscles by ultrasonographic method.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-35
* Not exercising regularly
* BMI between 18.9-24.9 kg/m2
* Volunteering to participate in the study
* Absence of chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program.
* Those who do not have a history of pregnancy, malignant hematological and oncological diseases
* Not smoking
* No musculoskeletal problems of the lower extremity in the last 6 months
* No previous history of lower extremity surgery in the last 1 year

Exclusion Criteria:

* Being outside the age range of 18-35
* Exercising regularly
* Being outside of the BMI 18.9-24.9 kg/m2 range
* Having chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program
* Those with a history of pregnancy, malignant hematological and oncological diseases
* Individuals who smoke
* Any musculoskeletal problem of the lower extremity in the last 6 months
* Having a history of lower extremity surgery in the last 1 year

Primary outcomes:
measure: Baseline knee joint cartilage thickness and muscles thicknesses
timeFrame: Just before first exercises session
measure: Knee cartilage thickness and muscles thicknesses after 6 weeks training program
timeFrame: After 6 weeks training program
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Mersin University Medical School
name: Orhan Güvener, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University Medical School
name: Figen Dağ, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05959564: A Chatbot Intervention for Reducing HPV Vaccine Hesitancy
Official title: A Chatbot Intervention for Reducing HPV Vaccine Hesitancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Anal Cancer
Penile Cancer
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this project is to test the efficacy of a chatbot intervention for reducing HPV vaccine hesitancy among African American parents. An online experiment will be conducted to test the effectiveness of the chatbot intervention with African American parents. Results of this project will inform future communication interventions for reducing vaccine hesitancy among African American parents.

Detailed description: The goal of this project is to test the efficacy of a chatbot intervention for reducing HPV vaccine hesitancy among African American parents. An online survey-experiment will be conducted. In the survey-experiment, participants will first answer questions related to their attitudes toward childhood vaccines and see a brief CDC message about HPV vaccine. Then they will be directed to interact with a chatbot designed to deliver personalized HPV vaccine messages (tailored to the participant's personality) or a similar chatbot with non-personalized messages. There will also be a control condition where participants will see the brief CDC message about HPV vaccine but will not interact with any chatbot. All participants will answer questions related to their attitudes toward HPV vaccination, intentions to vaccinate their children, as well as other message response measures.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Self-identify as Black or African American
* Parents of children under 18 years old
* Access to computer/laptop/mobile device and the Internet

Exclusion Criteria:

* Under 18 years
* Does not self-identify as Black or African American
* Not a parent of at least a child under 18 years old
* No access to computer/laptop/mobile device or the Internet

Primary outcomes:
measure: Attitudes Toward HPV Vaccination
timeFrame: baseline posttest (test took approximately 5 minutes to complete)
measure: Intentions Toward HPV Vaccination
timeFrame: baseline posttest (test took approximately 5 minutes to complete)
Secondary outcomes:
measure: Ratings of the Chatbot
timeFrame: baseline posttest (test took approximately 5 minutes to complete)
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland, College Park (Online Survey-Experiment)
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Xiaoli Nan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01445964: Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean
Official title: An Open-label, Single-dose, Three-treatment, Three-period Study to Investigate the Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: SLCO2B1 genotype
effect of apple juice
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-10-04
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-label, single-dose, three-treatment, three-period study to investigate the effect of SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in healthy male Korean.


Eligibility criteria: Inclusion Criteria:

* Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures

Exclusion Criteria:

* A subject with history of allergies including study drug (atenolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies

Primary outcomes:
measure: AUC of atenolol according to the SLCO2B1 genotypes
timeFrame: 0-48 hr after drug administration
Secondary outcomes:
measure: Blood pressure of the subjects who administered atenolol according to the SLCO2B1 genotypes
timeFrame: 0-48 hr after drug admnistration
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 0-48 hr after drug admnistration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03549364: Pilot Study of Myocardial Effects Following an Endurance Race
Official title: A Pilot Study of the Myocardial Effects of an Endurance Race as Evaluated by Computer Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Blood Flow
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Ten healthy subjects perform a baseline computer tomography (CT) of the heart and routine laboratory blood tests for myocardial injury and inflammation.

The same data are collected \<24 hours after an endurance race corresponding to a maraton run (i.e. about 40 km of running and/or about 2.5 hours hard training or more). A third collection of lab tests and CT is done a couple of weeks after the race. Magnetic resonance imaging is also performed in parallell to the CT on occasions 2 and 3 in most subjects, serving as a reference for determination of myocardial blood flow.

Detailed description: Ten healthy subjects perform a baseline computer tomography (CT) of the heart and routine laboratory blood tests (troponin T, hs-CRP, CK-mb etc) for myocardial injury and inflammation.

The same data are collected \<24 hours after an endurance race corresponding to a maraton run (i.e. about 40 km of running and/or about 2.5 hours hard training or more). A third collection of lab tests and CT is done a couple of weeks after the race. Magnetic resonance imaging (MRI) is also performed in parallell to the CT on occasions 2 and 3 in most subjects, serving as a reference for determination of myocardial blood flow. The CT of the heart includes contrast injection and blood flow will be determined by a recently developed based on very powerful computers using "machine learning".

Eligibility criteria: Inclusion Criteria:

Healthy subjects, experienced in long distance running

Exclusion Criteria:

Significant renal, kidney, heart, liver or musculoskeletal disease.

Primary outcomes:
measure: Change in myocardial blood flow by the race?
timeFrame: All investigations are performed < 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: University Hospital of Linkoping
Study officials:
References:
Clinical trial NCT06111664: Anergia-anhedonia by Lithium-induced Phosphorus Diabetes
Official title: Anergia-anhedonia by Lithium-induced Phosphorus Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mood Disorders
Keywords: Diabetes, Phosphate
Anergia-anhedonia
Lithium (Li+)
Mood Disorders
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥ 18 years old) balanced on Li+ (\> 6 months, regardless of the underlying pathology).

Brief summary: Lithium (Li+) is prescribed to 1‰ of the French population (\~ 60,000 patients). More than half of patients describe subjective symptoms linked to Li+ (SSL) similar to those of chronic fatigue syndrome: muscle weakness, fatigability, cognitive disorders, emotional blunting. SSL are the 2nd cause of stopping Li+ (28%), just behind kidney problems (30%).

In animals, the administration of lithium (Li+) increases the urinary excretion of phosphate (Pi) by 6, inducing phosphate diabetes (DPi). However, idiopathic forms of DPi explain up to 10-15% of chronic fatigue syndromes and these disappear when supplementing with Pi (± vitamin D).

In humans, the introduction of Li+ leads to a reduction in serum phosphate but we have not found any publication on the possible induction of DPi or on a possible link between DPi and SSL.

However, the dosages necessary to detect a DPi are carried out during the annual follow-up assessment of patients on Li+. All you have to do is calculate the standardized maximum reabsorption rate of Pi (TmPi) to make the diagnosis! Finally, if the patients presenting with DPi turn out to be the same as those who complain of SSL, we can imagine that correcting the first by simple supplementation with Pi (± vitamin D) could provide relief.

Detailed description: The aim of the study is to determine the prevalence of hypophosphatemia, DPi and SSL in a population of ambulatory patients controlled on Li+ (\> 6 months).

Eligibility criteria: Inclusion Criteria:

* Major subject (≥ 18 years old)
* Man or woman
* Subject balanced on Li+ (\> 6 months, regardless of the underlying pathology).
* Outpatient monitoring by one of the members of CEDRA (Alsace expert center for resistant depression).
* Subject not opposing, after information, the reuse of their data for the purposes of this research

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Subject under judicial protection
* Subject under guardianship or curatorship

Primary outcomes:
measure: Prevalence of hypophosphatemia, DPi and SSL at the population level.
timeFrame: from 6 months after lithium treatment (Li+)
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France
Study officials:
References: