cyrilzakka/clinical-trials huggingface dataset:
Migraine Headache Mitigation Utilizing Avulux

This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients

Participants:

This study will include a total of 40 participants aged 18 and over who have been screened for migraine headache history. Patients who attended the SBC Headache class with a diagnosis of Migraine from the last 12 months will be selected and assigned a number. Random number set will be used to select the 40 patients. Additional 40 patients will be selected to meet the total initial enrollment of 40 patients in the end. These 40 patients will be randomly assigned to Avulux or Control groups. Each patient will be assigned a unique identifier, and the rest of the correspondents will not use patient demographics.

Design:

The study will be a randomized, double blind, crossover interventional trial. Participants will be randomly assigned to one of 2 groups of 20. 1. Experimental Group: Participants in this group will wear Avulux lenses during the testing sessions. 2. Control Group: Participants in this group will wear placebo lenses that resemble Avulux lenses but do not have the same optical properties.

Procedure:

Participants will complete a baseline assessment and self-report migraine frequency using the Redcap migraine diary application. Participants will complete testing sessions with both Avulux and placebo lenses for the duration of 3 months and then switch lenses for the remaining 3 months for comparison and a total study period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient population: Individuals must have an existing diagnosis code of G43.1 (migraine w aura) or G43. 10 (migraine w aura, not intractable).
* Only Kaiser Permanente members receiving care at the Fontana Medical Service Areas will be in consideration.
* Patients that are \>18
* There will no restrictions based on biological sex.
* Participants will be referred to optical by provider (Neurologists/Optometrist/Primary Care physician).
* Participants must agree to not initiate any new medical management during the trial or be willing to voluntarily withdrawal from participating in the trial

Exclusion Criteria:

* Patients who do not have a migraine diagnosis code in their medical record.
* Patients that have started a new migraine medication within last 30 days
* Non-Members of Kaiser Permanente
Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Stable, active plaque psoriasis
* Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate

Exclusion Criteria:

* Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
* Systemic psoriasis therapy within 28 days prior
Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized periodontitis treatment.

Thirty patients with chronic periodontitis and a minimum of seven pockets (\>5

mm) in non-molars teeth that bled on probing will be selected. Patients will be randomly

assigned to ultrasonic periodontal debridement followed by local application of doxycycline

by PLGA microspheres (DB+DOX) and periodontal debridement followed by administration

of void PLGA microspheres (DB). Plaque, bleeding on probe, clinical attachment level

(CAL), and probing depth (PD) will be recorded at baseline, 3 and 6 months. Subgingival

biofilm samples will be collected from initially moderate (5 to 6 mm) and deep (≥7 mm)

pockets at baseline, 1, 3 and 6 months. Polimerase chain reaction (PCR) analysis will be

used to detect the frequency of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf),

Treponema denticola (Td), Aggregatibacter actinomycetemcomitans (Aa), and Prevotella

intermedia (Pi).

Eligibility Criteria:
Inclusion Criteria:

* Chronic generalized periodontitis (AAP,1999);
* At least 7 sites with probing depths \>5mm, and 2 sites with probing depth \>7mm;
* At least 20 teeth present;
* Systemically healthy.

Exclusion Criteria:

* Had received periodontal care 6 months prior to the study;
* Had taken medications known to interfere with periodontal health and healing 6 months prior to the study;
* Pregnants or lactants;
* Smokers;
* Sensitive to doxycycline.
BK329 and Body Fat Reduction

This clinical trial aims to determine whether BK329 reduces body fat in adults with overweight or obesity and to assess its safety.

The main questions are:

* Does BK329 reduce body fat in participants?
* What side effects occur when participants take BK329?

Researchers will compare BK329 to a placebo to evaluate its effectiveness in reducing body fat.

Participants will:

* Take BK329 or a placebo daily for 12 weeks.
* Visit the clinic every six weeks for checkups and tests.

Eligibility Criteria:
Inclusion Criteria:

* individuals with a Body Mass Index (BMI) between 23 and 30 kg/m2.
* Individuals who have provided written consent on the consent form.

Exclusion Criteria:

* Subjects with severe cerebrovascular disease (e.g., stroke, cerebral hemorrhage), heart disease (e.g., angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumors within the last 6 months. (However, subjects with a history of these diseases who are clinically stable may participate at the investigator's discretion.)
* Uncontrolled hypertensive patients (blood pressure ≥160/100mmHg, measured after 10 minutes of rest).
* Diabetic patients with poor blood glucose control (fasting glucose ≥160mg/dL).
* Subjects undergoing treatment for hypothyroidism or hyperthyroidism.
* Subjects with creatinine levels ≥ 2 times the upper limit of the research institution's normal range.
* Subjects with aspartate transaminase or alanine transaminase levels ≥ 3 times the upper limit of the research institution's normal range.
* Subjects experiencing severe gastrointestinal symptoms such as heartburn or indigestion (lactose intolerance).
* Subjects who have taken weight-altering drugs (absorption inhibitors, appetite suppressants, obesity-related supplements, psychiatric drugs, beta-blockers, diuretics, contraceptives, steroids, or female hormones) within the last month.
* Subjects who have participated in commercial weight loss programs within the last 3 months.
* Subjects who have participated in or plan to participate in another clinical trial within the last month.
* Alcohol abusers.
* Subjects who quit smoking within the last 3 months.
* Pregnant or breastfeeding women or those planning pregnancy during the trial period.
* Subjects with allergies to any components of the study foods.
* Subjects deemed inappropriate for the study by the investigator for other reasons.
RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil

The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with a/m non-squamous NSCLC with or without AGA and received at least 1 line of systemic treatment after failing PTC between January 2017 and December 2022.

The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with advanced/metastaic non-squamous NSCLC with or without AGA and who have failed platinum-based chemotherapy and immunotherapy (for patients without AGA) or platinum-based chemotherapy and at least 1 line of targeted therapy (for patients with AGA). The study will be conducted on one cohort of patients regardless their AGA status. The study index date will be defined as first dose of any agent after PTC, with specific treatments received for AGA and non-AGA patients in the preindex period. We will also conduct a subgroup analysis on NSCLC pre-defined subtypes (sample size permitting): EGFR mutant, ALK translocation, ROS1 translocation, MET1 mutant, HER-2 mutant, BRAF mutant, pan-wild-type PD-L1 \>50%.

Eligibility Criteria:
Inclusion Criteria

* Confirmed diagnosis of patients with non-squamous NSCLC stage IIIB/IIIC not eligible for curative-intent therapies or stage IV/M1 (a/m NSCLC) with or without actionable genomic mutations (i.e., EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, RET, HER-2)
* Aged at least 18 years at first diagnosis of a/m NSCLC
* For the AGA subgroup, having received platinum-based chemotherapy, having received at least one target approved therapy.
* For the non_AGA subgroup,should have received either sequential or concurrent use of ICI and PTC)
* Patient must have received at least line of therapy of an active agent after failing PTC.

Exclusion Criteria

* Patients with evidence of other primary malignancies (apart from basal cell carcinoma and melanoma) within 1 year prior to the index date will be excluded from both the study cohorts.
* Patients who participated in an investigational clinical trial for the treatment of any cancer, including NSCLC, or any early access program from 2018 onward.
Ultrasonographic Assessment of Carpal Tunnel Syndrome

Mucopolysaccharidosis are lysosomal storage disorders such as Hunter, Hurler, and Sanfilippo syndromes. These patients have a genetic enzyme deficiency that results in the inability to degrade glycosaminoglycans. The glycosaminoglycans accumulate in lysosomes causing cell enlargement and subsequent dysfunction. The accumulation occurs in all tissues including cartilage, joint capsule, and tendons and can lead to carpal tunnel syndrome, trigger digits, and various other orthopaedic manifestations \[Van Heest, White\]. These children often suffer from severe cognitive impairment and are often unable to communicate pain or numbness. Carpal tunnel syndrome is almost always present, but may not become apparent until symptoms are severe and loss of function has occurred. The current gold standard for diagnosis consists of electromyographic (EMG) and nerve conduction velocity (NCV) studies under sedation or general anesthetic \[Khanna\].

Primary Objective: The investigators plan to correlate EMG findings and median nerve cross-sectional area in children with mucopolysaccharidosis. The investigators hypothesis is that ultrasonography of the carpal tunnel in patients with mucopolysaccharidosis will prove to be an effective, reliable, and safe method to evaluate the median nerve, thus avoiding the need for EMG studies and anesthesia.

Secondary Objective: The investigators want to determine the cross-sectional area of the median nerve using ultrasonography in a cohort of healthy children, ages 3-12. The investigators plan to evaluate a cohort of healthy children to determine a normal cross-sectional area of the median nerve.


Eligibility Criteria:
Inclusion Criteria:

For the first arm of the study (25 participants):

* Children with mucopolysaccharidosis presenting to the senior author's clinic with signs or symptoms of carpal tunnel syndrome will be enrolled to receive both an EMG and carpal tunnel ultrasound of the upper extremities.

For the second arm of the study (100 participants):

* Healthy children ages 3-12 with no acute upper extremity trauma or history of mucopolysaccharidosis.
* 25 additional participants requested in case of inconclusive ultrasound results, patient removal, or other unusable results.

Exclusion Criteria:

First arm:

* Children with mucopolysaccharidosis who have undergone previous treatment for carpal tunnel syndrome.

Second arm:

* Acute (\<3month) wrist or hand surgery/injuries.
* Unable to obtain parental consent or patient assent.
* History of mucopolysaccharidosis.
* Non-english speaking.
* Cognitive impairment.
Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome

Phase III randomized controlled trial on men and women with Metabolic syndrome (MetS) to test the hypothesis that comprehensive life-style changes and/or metformin treatment prevent age-related chronic non-communicable diseases (ArCD).

The aim of the present study is to evaluate the effect of a comprehensive life-style intervention (including moderate physical activity and Mediterranean/macrobiotic diet with moderate calorie and protein restriction), and of treatment with Metformin (a calorie restriction mimetic drug) for the prevention of ArCD.

Phase III randomized controlled trial on men and women with MetS to test the hypothesis that comprehensive life-style changes and/or metformin treatment prevent ArCD.

Design:

2x2 factorial: 2,000 volunteers will be randomized in four equal groups of 500 each, and allocated to the following treatments: METFORMIN (1700MG/DAY) + ACTIVE LIFESTYLE INTERVENTION PLACEBO + ACTIVE LIFESTYLE INTERVENTION METFORMIN (1700 mg/day) alone PLACEBO alone The metformin /placebo component of the study will be double blind.

Eligibility Criteria:
Inclusion Criteria:

* Age 55-74, waist circumference equal or greater than 85 cm for women and 100 cm for men, plus at least two other factors among those defining the MetS

Exclusion Criteria:

* Diagnosed diabetes (or baseline fasting glycemia above 7mmol/L at baseline examination)
* Cancer (except skin carcinoma) diagnosed in the last 5 years, or under treatment
* Excessive frailty: in absence of agreed-upon measurements parameters and cutoff points, the investigator will exclude subjects under the lower 5th percentile of the muscular mass distribution estimated by impedance in previous studies
* Conditions that contraindicate the use of MET because might favour lactic acidosis:

  * Renal, cardiac, hepatic, or respiratory insufficiency
  * Serum creatinine \<124μmol/L, or proteinuria at baseline examination
  * Current treatment with K-sparing diuretics, or with proton pump inhibitors
  * Excessive alcohol consumption
* Distressing side effects of MET treatment. Nausea and diarrhoea typically occur in about one third of patients receiving MET for the first time at full dose. To avoid dropouts for gastrointestinal discomfort we will treat all volunteers with half the planned dose for one month in order to exclude intolerant subjects before randomization. Participants randomized in the intervention group will continue to take half a dose for one month and then shift to the full dose.
The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes

Youth with evidence of virologic failure defined as an HIV VL\>400 copies/mL on two consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression.

Title The Peer Support Intervention - supporting HIV positive adolescents in Zimbabwe to improve HIV care continuum outcomes

Short Title The Peer Support Intervention

Study Design Prospective randomized study

Study Duration 2 years

Study Population 250 Youth (ages 10-24 years) with virologic failure

Study Outcomes Primary Outcomes

1. Virologic suppression rate in the The Peer Support Intervention group compared with the standard of care group following 48 weeks in the Peer Support Intervention.

Secondary Outcomes

1. Frequency of acquired drug resistance mutations among youth failing ART.
2. Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy
3. Prevalence of psychological distress (measured using PHQ-A and SSQ) after 48 weeks of enrolment in the Peer Support Intervention compared with the standard of care
4. Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations).
5. Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques.

Description of Intervention Youth with evidence of virologic failure defined as an HIV VL\>400 copies/mL on two consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression.

Study Sites Parirenyatwa Hospital Family Care Centre

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV positive
* Age \> 10 years and ≤ 24 years
* Two consecutive HIV VL\>400 copies/mL, at least one month apart
* Residence within 50 km of Harare
* Able to provide written informed consent (age 18 or older) or assent (age \<18 years)

Exclusion Criteria:

* Inability to provide informed consent or assent
* Past or current involvement in the Zvandiri Intervention Program
Targeting Large-scale Networks in Depression With Real-time fMRI (Functional Magnetic Resonance Imaging) Neurofeedback

The purpose of this study is to develop a technique called real time fMRI neurofeedback.

This technique uses a functional MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. The researchers think that this may be helpful in managing psychiatric symptoms.

This study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial.

Therefore, this registration will include phase 2 at this time.

During the second phase of the project healthy participants (approximately 12) will have three study visits (two fMRIs) over 2-4 weeks.

Note: As the study is a feasibility/development study, alterations of the task design for the primary outcome measures will be done to achieve objectives of developing at task that recruits from the target region (salience network). In phase 1 of the study, changes to the task are ongoing, and the same may occur for phase 2 in order to develop a viable neurofeedback paradigm. Therefore, detailed descriptions of the outcome measures are not entered at this time, as we don't know exactly what those are. When we do, the entry will be updated.

Note: As of 7/26/2024, the study is rolling back from 'Completed' to 'Recruiting' status in order to include more healthy controls and temporarily resume active development of the task design.

Eligibility Criteria:
Inclusion Criteria (phase 2 participants):

* Ability and willingness to give informed consent to participate
* Not taking any medication, prescription or non-prescription, with psychotropic effects (birth control medications allowed)
* If a woman of child-bearing age, not pregnant or trying to become pregnant
* No history of serious neurological illness (including, but not limited to, seizures/epilepsy) or current medical condition that could compromise brain function, such as liver failure
* No history of closed head injury (see protocol for more details)
* Ability to tolerate small, enclosed spaces without anxiety
* No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition
* Size compatible with scanner gantry

Exclusion Criteria (phase 2 participants):

- History of past or current mental illness (except for simple phobias), but prior history of substance dependence ok if in remission for greater than 5 years
Stavanger University Hospital Inflammatory Bowel Disease Trial

The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined.

Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.

none considered needed

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed IBD

Exclusion Criteria:

* previous IBD with specific treatment within 10 year
* inability to consent
* inability to adhere to treatment protocol
Intrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI

Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.

This is a single blinded randomized trial comparing the effect of of platlet rich plasma versus hormonal therapy on endometrial thickness and consequently endometrial receptivity. The primary endpoint of this trial is clinical pregnancy rate.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing ICSI
* endometrial thickness less than 7 mm on early follicular phase

Exclusion Criteria:

-
Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System

The purpose of this study is to assess the feasibility and the reliability of a telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease.

The feasibility is assessed using the patient's satisfaction and it ease of use.

The reliability of the remote telemonitoring system is assessed comparing the local data (extracted from the monitoring device itself) and the data transmitted through the telemonitoring platform.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years ;
* Chronicle obstructive pulmonary disease stage II/III/IV (FEV1 \< 80%) ;
* Referred for pulmonary rehabilitation.

Exclusion Criteria:

* Pregnant woman or likely to be ;
* Patient under guardianship ;
* Neuropathic disorder ;
* Contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation ;
* Progressive cancer.
13-cis Retinoic Acid (Isotretinoin) and Sperm Production

This study aims to evaluate the effectiveness of weekly administration of isotretinoin (40 mg) in increasing sperm production in men with oligozoospermia, a condition characterized by a low sperm count. Participants will be randomized into two groups: one receiving isotretinoin and the other a placebo. The primary outcome will be the change in sperm production over 20 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be infertile men (no pregnancy with partner with normal cycles and normal hysterosalpingogram despite \>1 year of unprotected intercourse).
* Abnormal sperm analyses with a total, motile sperm count of less than 10 million sperm as assessed by semen analysis on two occasions separated by one week.
* Male patients aged 21-55 years
* Affiliation with a social security system
* Ability to provide informed consent

Exclusion Criteria:

* -Men participating in another clinical trial
* Clinically significant abnormal findings at screening
* Known genetic infertility (e.g. Klinefelter syndrome or Y-chromosome microdeletions),
* Hypogonadotropic hypogonadism (that might respond to gonadotropin injections),
* Severe mental health problems requiring medications
* Current therapy with retinoic acid (e.g. Accutane) or vitamin A.
* History of psychiatric disorders (e.g., depression, suicidal tendencies).
* Abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction.
* Men currently receiving tetracycline containing medications
* Men who have used isotretinoin within eight weeks of the start of dosing
* Men with elevated serum triglycerides