louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04871087: Green Light Effects on Anxiety
Official title: Narrow Band Green Light (NBGL) Effects on the Treatment of Anxiety During Psychotherapy Sessions: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Lead sponsor: The Green Light Study Center
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm assesment
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improves outcome of psychotherapy sessions for the treatment of anxiety.

This is a within-subject study design that examines NBGL effects (as compared to white light) on anxiety level and treatment success, as evaluated by the treating psychotherapist and the patient. For each participant, the study will consist of 8 therapy sessions, each lasting 60 minutes, in which light conditions will be presented in the following order

Session 1: White light, Session 2: white light, Session 3: NBGL (i.e., green light), Session 4: NBGL, Session 5: NBGL, Session 6: NBGL, Session 7: White light, Session 8: White light

Effects of lights (white vs.NBGL) on anxiety level will be evaluated at the beginning and end of each therapy session by the patient, using a validated questionnaire. At the end of each session, the treating psychotherapist will fill another evaluation form that summarizes her/his impression of the treatment success or lack of.

Detailed description: Each patient is treated once a week and thus, study participation time is expected to last 8 weeks. Patients will self evaluate their anxiety level at the beginning and end of each of the 8 therapy sessions by completing the 20-questions State-Trait Anxiety Inventory (STAI Form Y-1).

Therapists will fill the following form after each of the 8 sessions:

Did you feel any difference while working with the patient in the green light as compared to regular room light?

Check all that apply:

* I was more focused
* I was more relaxed
* The patient was more relaxed
* The patient was more engaged
* The patient seemed more open
* The therapy progressed further

Eligibility criteria: Inclusion Criteria:

* Diagnosis of anxiety
* Being a patient at the Delray Center
* Older than 18 and younger than 95
* Being able to communicate in English
* Willingness to sign informed consent

Exclusion Criteria:

* Co-morbid psychiatric conditions

Primary outcomes:
measure: Anxiety
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Delray Beach
country: United States
facility: Delray Center for Healing
state: Florida
Study officials:
References:
Clinical trial NCT00265187: The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis.
Official title: The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis in Northern Israel.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infection
Children
Keywords: child, bronchiolitis,
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2005-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 0-24 months hospitalized with acute bronchiolitis

Brief summary: Sputum specimens will be obtained from children \< 2 years of age and processed by different mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical and epidemiological data will also be obtained.

Detailed description: The purpose of the study is to asses the various pathogens of bronchiolitis in children and its' clinical manifestations. Prospective study in 3 Medical centers in Northern Israel. Included will be about 200 infants and children \< 2 years hospitalized with bronchiolitis. From each child sputum specimen will be obtained and processed for HUMP - PCR, Pertussis - PCR, RSV - ELISA, DFA, PCR, Influenza A, B, Parainfluenza 1,2,3 - DFA, PCR, Adenovirus - DFA. Epidemiological data will be obtained for every child by structured questioner. Clinical data will be daily obtained by scoring system.

Eligibility criteria: Inclusion Criteria:Age 0-24 months, hospitalized children, -

Exclusion Criteria:Previous hospitalization, previous RSV immunization, immunocompromised patient, previous inclusion in this study, inclusion in another study.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric department A, HaEmek Medical Center
city: Haifa
country: Israel
facility: Maier Hospital
city: Haifa
country: Israel
facility: Pediatric Depart ment , Bnai Zion Hospital
Study officials:
affiliation: HaEmek Medicak Center, Afula, Israel
name: Dan Miron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00201487: Choline Quantification in Breast Cancer by MRS
Official title: Choline Quantification in Breast Cancer by MRS
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Neoplasms
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Norwegian Women´s Public Health Association
First posted: 2005-09-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: breast cancer

Brief summary: Choline has been found in increased concentration in breast cancer patients. Hypothesis: The choline signal as observed by MRS is sensitive to treatment, and a positive response to treatment will give a reduction in choline concentration.

The purpose of this study is to establish methods for quantification of choline in breast cancer by MRS

Detailed description: 1. Establishment of new MRS sequence for choline quantification of choline. This sequence is choline-selective, and signals from water and lipids are suppressed simultaneously.
2. Compare to different methods for choline quantification. The first method is quantification through an external phantom standard, containing a known concentration of choline. The other method is based on the utilisation of internal water signal as a reference.

Both calculations can be performed from the same MR exam. Ten patients will be included in the study.

Eligibility criteria: Inclusion Criteria:

* breast cancer

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NTNU, Faculty of medicine,
name: Tone Bathen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04586387: The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
Official title: The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: transcranial magnetic stimulation
non-invasive brain stimulation
magnetic resonance imaging
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 12
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: BASIC_SCIENCE

Brief summary: The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. It has been studied by researchers for 20 plus years. This brain stimulation device and technique used in this study is an investigational device that has not been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device brochure can be found at: https://www.magstim.com/product/rapid-family/


Eligibility criteria: Inclusion Criteria:

* nonimpaired individuals
* free of contraindications for MRI and TMS

Exclusion Criteria:

* musculoskeletal injury of the arm
* neurologic deficit affecting motor or sensory function
* concurrent severe medical illness
* diagnosis of SARS-CoV2, or symptoms consistent with COVID-19, or close contact with someone with SARS-CoV2 in the past 3 weeks

Primary outcomes:
measure: Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle
timeFrame: approximately 7 days
measure: Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle
timeFrame: approximately 7 days
measure: Change in Corticomotor Excitability With Active Stimulation on Finger Muscle
timeFrame: approximately 7 days
measure: Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle
timeFrame: approximately 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Carrie Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205487: PrEP Readiness Interventions for Supporting Motivation
Official title: PrEP Readiness Interventions for Supporting Motivation in Stimulant-Using Sexual Minority Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Pre-exposure Prophylaxis
Substance Use Disorders
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: City University of New York
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-12-19
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Multiple Assignment Randomized Trial (SMART)
Primary purpose: PREVENTION

Brief summary: The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men (MSM) into the pre-exposure prophylaxis (PrEP) care continuum.

Detailed description: In Stage 1, participants will be randomized to receive either: 1) three months of CM; or 2) two sessions of MI. All participants will be assessed at three months post-randomization for non-response. In Stage 2, a second randomization where non-responders (i.e., those who have not filled a PrEP prescription) are assigned to: 1) Switch to sequentially receive the other intervention (i.e., CM+MI or MI+CM); or 2) Continue with assessments only (i.e., CM-Only or MI-Only). All participants will complete a final assessment at 6 months.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Sexually active cisgender sexual minority man
* Reports using stimulants in the past three months
* HIV-negative serostatus
* Meets Centers for Disease Control and Prevention (CDC) criteria for PrEP eligibility

Exclusion Criteria:

* Currently prescribed PrEP
* Unable to provide informed consent
* Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to participate

Primary outcomes:
measure: Filling a prescription for PrEP
timeFrame: 6 Months
Secondary outcomes:
measure: Self-reported PrEP clinical evaluation by a medical provider
timeFrame: 6 Months
measure: Self-reported stimulant use severity
timeFrame: 6 months
measure: Self-reported condomless receptive anal sex (Receptive CAS)
timeFrame: 6 months
measure: Self-reported condomless insertive anal sex (Insertive CAS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Adam W Carrico, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04826887: SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia
Official title: SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BPH
Benign Prostatic Hyperplasia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 15
Sex: MALE
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: Patients will present to clinic for treatment of BPH assessment and evaluation per routine clinical care. Patients will be identified by clinical care team as an eligible candidate for study participation.

Brief summary: To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate.

Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations

Detailed description: Thulium laser is continuous wave laser which offers numerous potential benefits compared to alternative lasers and surgical procedures used for BPH. The SOLTIVE Laser system is a compact system which is significantly smaller than Holmium laser systems. The laser fiber is also smaller in diameter allowing for improved maneuverability with decreased fiber degradation and endoscope damage. The continuous wave pattern produces fast, hemostatic cuts during the removal and furthermore the associated hemostasis improves the visual field. Additionally, based on the 1940nm wavelength is absorbed nearly five times more in water. For all the stated reasons, the SOLTIVE Thulium Laser should improve the enucleation efficiency and warrants further investigation.

Eligibility criteria: Inclusion Criteria:

1. Patients must be 18 years of age or older
2. Patients must be diagnosed with benign prostatic hyperplasia
3. Patients must opt for surgical management of their BPH with laser enucleation

Exclusion Criteria:

1. Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
2. Patients with prostate glands greater or equal to 200 grams
3. Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.

Primary outcomes:
measure: Comparing the SOLTIVE Thulium Fiber to the Holmium Laser for HoLEP
timeFrame: up to 1 year
Secondary outcomes:
measure: Compare intraoperative components between the two surgical approaches
timeFrame: up to 1 year
measure: Compare post-operative outcomes of the two surgical approaches
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medcial Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Donald Neff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05513287: With Continuity of Covid-19 Pandemic, Have Our Anethetic Choices for Caesrean Section Changed ?
Official title: Retrospective Analytic Study Will be Performed to Investigate if There Was a Change in the Choice of Anethetic Technique for Casrean Section With Continuation of Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pandemic
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Number of regional and general anethesia used in covid waves

Brief summary: This retrospective analytic study will be petformed to investigate if there was a change in the choice of anaethetic technique for caesarean sections with continuation of the COVID-19 pandemic .

Detailed description: The number of regional and general anethesia techniques used with detailed number ofspinals epidurals as well as combined spinal epidurals that were provided .

Eligibility criteria: Inclusion criteria:

* pregnant women
* suspected or infected with covid-19
* women undergo cesarean section .

Exclusion criteria:

* normal delivery
* abortion

Primary outcomes:
measure: Type of anethesia
timeFrame: 2020,2021
measure: Out come of mother
timeFrame: 2 years 2020,2021
Secondary outcomes:
measure: Income of mother
timeFrame: 2020,2021
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university
Study officials:
References:
Clinical trial NCT01240187: A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
Official title: A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 6 x2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Partial Onset Epilepsy
Keywords: epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.

Detailed description: A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects aged between 18-55 years.
* BMI of 18-32 kg/m \^2.
* Willing and able to provide written informed consent.

Exclusion criteria:

* Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
* Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
* Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
* Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
* Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
* Subjects who consume more than five caffeinated beverages per day.
* Subjects who smoke more than 5 cigarettes per day.
* Subjects with a history of drug abuse or who have a positive urine drug screening test.
* Women who do not agree to use two methods of contraception.

Primary outcomes:
measure: To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Quotient Clinical
name: Dr Joanne Collier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01195987: Immune Dysregulation in Hepatitis C Patients With or Without Arthritis
Official title: Immune Dysregulation in Hepatitis C Patients With or Without Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C Patients
Keywords: Hepatitis C
Arthritis
Lead sponsor: The Center for Rheumatic Disease, Allergy, & Immunology
Sponsor class: OTHER
Collaborators: name: St. Luke's Hospital
First posted: 2010-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis positive patients with and without osteoarthritis, with a group of Hepatitis C negative and no osteoarthritis to serve as controls.

Brief summary: The purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C.

Detailed description: Patients will provide one blood sample after qualifying for the study, and signing consent. The patients will have a skin test TB, Candida, and Trichophyton placed and will read the results themselves and mail back the card with the measurements to be recorded. Labs will test for ESR, CBC, CRP, antiCCP, Cryoglobulins, RF, CH50, C3, C4, Flow cytometry, and would have already been tested for HIV and Hepatitis C.

Eligibility criteria: Inclusion Criteria:

* All adults 18 or older, 20 will have hep C positive with a viral load withen 6 mo. of enrollment.
* Either interferon or antiviral naive or those who failed interferon or antiviral therapy more than 6 mo. prior to enrollment.
* 10 normal healthy controls- Hep C neg and without osteoarthritis (OA).

Exclusion Criteria:

* HIV patients
* Those with concomitant alcoholic liver disease
* Patients with Rheumatoid Arthritis (RA) or other autoimmune disorders.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Center for Rheumatic Disease, Allergy & Immunology
state: Missouri
Study officials:
affiliation: Center for Rheumatic Disease, Allergy & Immunology
name: Nabih I Abdou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02971787: Salt Intake and Lactobacillus Abundance
Official title: Influence of Increased Salt Intake on Lactobacillus Abundance in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Probiotics
Sodium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative abundance of gut lactobillus species in healthy men


Eligibility criteria: Inclusion Criteria:

* Healthy men
* 18 - 50 years
* Body mass index 18,5 - 29,9 kg/m2

Exclusion Criteria:

* Clinically relevant heart, lung, liver, and kidney disease
* Current or chronic infections
* Habitual intake of probiotics or dietary supplements

Primary outcomes:
measure: Decrease of relative abundance of four lactobacillus species
timeFrame: 14 days
Secondary outcomes:
measure: Increase of systolic blood pressure
timeFrame: 14 days
measure: Increase of pulse wave velocity
timeFrame: 14 days
measure: Increase of lymphocytic pro-inflammatory mediators
timeFrame: 14 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental and Clinical Research Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Anja Maehler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahler A, Wilck N, Rauch G, Dechend R, Muller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020 Dec 29;21(1):1032. doi: 10.1186/s13063-020-04973-0.