cyrilzakka/clinical-trials huggingface dataset:
rTMS for Neuroenhancement

The purpose of this pilot study is to evaluate the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Sleep Quality, Mood and Memory.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 22 to 70 years of age
* Freely provides written informed consent
* In good general health, as ascertained by medical history
* If female, not breastfeeding, no known or suspected pregnancy, a status of non- childbearing potential or use of an acceptable form of birth control
* If subject is in menopausal transition, the subject must be stabilized on hormonal treatment.
* Subject scored a 2 or higher on PHQ-9 sleep related question (#3), OR subject scored 2 or more on at least 2 QIDS-SR sleep related questions (#'s 1-4)
* If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.

Exclusion Criteria:

* Subject satisfies any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
* History of head trauma associated with loss of consciousness or diagnosed as concussion.
* History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
* Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
* Has an implanted stimulator device (including device leads) in or near the head.

  (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
* Has medication infusion device.
* Subjects with any prior TMS or MRI complications which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation,
* Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence.
* Current diagnosis or known history of neurologic or neuropsychiatric disease (e.g., epilepsy, convulsion, seizure)
* Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
* Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.
Detection of COVID-19 Using Breath Analysis - Validation Study.

Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.

A diagnostic prospective single-site study, with no anticipated risks or constraints.

Primary objective- To validate the value of a set of breath VOC biomarkers that enable the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison to the gold-standard testing methodology.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years at the time of consent
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Was not treated with Anti-viral drugs

Exclusion Criteria:

* Age under 18 years old
* Under guardianship or deprived of liberty
* Pregnant or lactating woman
Artificial Intelligence (AI) Cytopathology Trial

Purpose The primary objective of the study is to compare interpretation of EUS FNA/FNB samples for adequacy between ROSE and AI at bedside. To compare accuracy of preliminary diagnosis results between ROSE and AI at bedside versus final pathology report.

Research design This is a prospective single center study to compare performance characteristics in the interpretation of EUS FNA/FNB samples between AI and ROSE.

Procedures to be used Eligible patients will undergo EUS guided FNA/FNA of PSLs using standard of care. Sample slides are prepared by a cytopathologist at bedside and observed under a microscope. At the same time, the slides are scanned using a slide scanner and those images are saved for interpretation by AI at a later time.


Eligibility Criteria:
Inclusion Criteria:

* Have EUS finding of a PSL;
* Do not have contraindications for FNA/FNB.

Exclusion Criteria:

* Inability to provide informed consent for the procedure;
* Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.
Examining Two Print-based Exercise Interventions for Women

Print-based interventions, specifically interventions that are theoretically-based have been shown to be effective for individuals. These types of interventions are of particular importance for those individuals who, due to transportation, work, family, social, or financial demands have difficulty participating in face-to-face programs. Therefore, we decided to test 2 such print based programs for women.

We conducted a randomized controlled trial in which participants were randomly assigned to one of three groups: (1) Choose to Move (CTM), a gender-targeted intervention (2) Jumpstart, a motivationally-tailored print-based intervention, or (3) Wellness contact control group. Objective and self-report measures of physical activity and psychosocial mediators of change were assessed at 3 months to evaluate the efficacy of the programs and maintenance of these programs will be conducted by examining a 9 month follow-up phase. This design allows a direct comparison between two print-based physical activity self-help programs. The use of non face-to-face interventions is critical to reach the large numbers of women in United States who are not physically active. Tailored print materials (i.e., Jumpstart) will enable participants to have information that is matched to their level of motivation, and thus might be expected to be more efficacious than a standard self-help intervention.

Eligibility Criteria:
Inclusion Criteria:

* healthy women
* sedentary

Exclusion Criteria:

* participating in \> 90 minutes of purposeful physical activity (e.g., walking, cycling).
* medical problems that could potentially impede or exacerbated by physical activity
* history of coronary heart disease
* myocardial infraction
* symptoms of angina
* stroke
* diabetes
* osteoporosis
* osteoarthritis
* severe orthopedic problems.
* a planned move from the area within the next year
* current or planned pregnancy
* hospitalization for a psychiatric disorder within the last 3 years
* current suicidal or psychotic episodes
* currently using certain prescription medication such as beta blockers for hypertension
Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

This study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is SODA score, secondary endpoint is endoscopic classification (Sydney).


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* being literate
* diagnosis of dyspepsia
* initial SODA score \> or = 25

Exclusion Criteria:

* pregnancy
* lactation
* allergy to Maytenus species
* fail to use the drug for 3 uninterrupted weeks
* new onset serious adverse events, attributable to the drug
* patient's request
Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants

The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight \< 1250 g and have ureaplasma urealyticum colonization.


Eligibility Criteria:
Inclusion Criteria:

* The babies under 1250 gram
* The babies must be appropriate for gestational age

Exclusion Criteria:

* Multiple congenital anomalies or known syndromes
* Intrauterine growth retardation with birthweight less than 10 percentile for gestational age
Rescue Stenting and Intravenous Thrombolysis in Patients with Large Vessel Ischemic Stroke

Intravenous thrombolysis (IVT) and mechanical thrombectomy (MT) are the standard of care for treating selected patients with acute large-vessel occlusion stroke (LVOS). Successful revascularization is strongly correlated with favorable outcomes. Nevertheless, recanalization failure with stent retrieval and contact aspiration has been observed in up to 29% of patients. If primary thrombectomy fails to achieve recanalization, rescue stenting (RS) has proven to be a feasible rescue therapy. Currently, approved evidence-based alternatives for LVOS patients who have failed MT are lacking, but permanent stenting is suggested as a rescue treatment in expert consensus statements.

Dual antiplatelet therapy (DAPT), typically consisting of clopidogrel and aspirin, is recommended after stent implantation to reduce the risk of stent thrombosis; however, these medications are not suitable in the acute setting, and optimal platelet inhibition strategies remain unclear. Glycoprotein (GP) IIb/IIIa receptor inhibitors have intravenous administration, a rapid onset of action, and their effects subside within a few hours after discontinuation. For these reasons, an increasing number of studies have investigated their use in conjunction with primary stenting for acute stroke. Currently, there is no evidence supporting the superiority of any particular antithrombotic strategy, so decisions are guided by clinical judgment.

An additional challenge for clinicians arises when IVT is combined with stenting. Stroke guidelines recommend starting antiplatelets 24 hours after IVT and the risk associated with antithrombotic therapy within the first 24 hours after IVT remains uncertain.

This is multicenter, prospective, observational study of patients with LVOS undergoing mechanical thrombectomy and rescue stenting. The aim of this study is to evaluate real-world antithrombotic strategies in emergency stenting, particularly in patients treated with IVT, and to assess the safety of emergent stenting following intravenous thrombolysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with large vessel occlusion strokes undergoing thrombectomy and rescue stenting within 24 hours of stroke onset
* Patients ≥ 18 years of age

Exclusion Criteria:

* Patients \< 18 years
* Refusal to give informed consent
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse

This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males or females (18-70 years of age; \< 104 kg)
* Capable of giving informed consent
* Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
* Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
* Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.

Exclusion Criteria:

* Certain specified co-morbidities (including pregnancy)
* Taking certain proscribed medications
* A medical regimen that has changed in the month prior to screening
* Inability to undergo requisite MRI evaluations
* Drug or alcohol abuse
* Any other reason for which, in the opinion of the Investigator, the subject should not participate in the study.
A Default Option to Enhance Dietary Quality in Participants With Food Insecurity

Food insecurity is associated with an increased risk of overweight/obesity and weight-related chronic illnesses. The availability of a default option (i.e., option a consumer selects if no active choice is made) has been shown to effectively nudge consumer behavior. An online default option (i.e., prefilled grocery shopping cart) was previously shown to positively impact food selection in an online grocery shopping task.The present study provides preliminary evidence for the efficacy of an online default option in enhancing the nutritional quality of online grocery purchases in individuals with food insecurity.

Food insecurity is associated with an increased risk of overweight/obesity and weight-related chronic illnesses. The present study provides preliminary evidence for the efficacy of an online default option in enhancing the nutritional quality of online grocery purchases in individuals with food insecurity.

In behavioral economics, the default option refers to the option a consumer selects if no active choice is made. This study aims to determine whether the use of a default prefilled online grocery shopping cart results in the purchase of healthier food items in individuals with food insecurity, compared to nutrition education. The default approach, a non-monetary intervention that manipulates choice architecture, improves food choice behaviors in individuals facing significant financial constraints. The intervention is potentially broadly scalable via online platforms.

It was hypothesized that the default option effectively increases the nutritional quality of foods purchased online, compared to nutrition education.

Fifty participants recruited from food pantries in New York in 2018 were randomized to: (1) review nutrition information before selecting groceries for a week using a local grocery store's online shopping and delivery service (n = 23) or (2) modify a default prefilled online shopping cart containing groceries that meet nutritional guidelines according to their personal preferences (n = 27).

Primary outcome measures capture the nutritional quality of groceries purchased. Our primary nutritional outcomes include servings of whole grains fruits and vegetables, fiber, daily calories, fat, saturated fat, sodium and cholesterol content.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 or older
2. single person household
3. fluent in written and spoken English
4. able to provide informed consent
5. food-insecure (verbal agreement that they consider themselves to be of that category) but not currently receiving SNAP benefits (as they would otherwise have access to twice the amount of benefits typically allocated; please note that all participants will be provided with information about enrollment in SNAP following study participation)
6. current residence in a zip code served by Price Chopper's delivery program

Exclusion Criteria:

1. None of the following dietary restrictions: vegetarian/vegan, gluten-free/celiacs disease, and lactose intolerant
2. current residence outside of a zip code served by Price Chopper's delivery program
Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria

The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Provided informed consent
2. Age 18 years or older
3. Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
4. Urinary oxalate ≥ 50 mg/24 hr
5. Has at least 1 documented kidney stone within 2 years

Exclusion Criteria:

1. Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30 mL/minute/1.73 m2
2. Has a known genetic, congenital, or other cause of kidney stones
3. Unable or unwilling to discontinue Vitamin C supplementation \>200mg daily
4. Cannot establish baseline kidney stone burden
Evaluation of the Efficacy of Radiofrequency in the Treatment of Renal Tumors

Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and retrospectively in all centers to obtain the required number of patient followed during 5 years.

Radiofrequency ablation (RFA) of renal cell carcinoma (RCC) is actually used in elderly patients with small renal tumors (diameter ≤ 4 cm) and presenting a high risk of surgery (due to co-morbidity) and/or reduced renal function. RFA is a minimally invasive technique, considered as an alternative to surgery to limit morbidity and to preserve kidney function. The technique is well known and has proven his efficacy for the treatment of small tumors.

An enlargement of the indications of RFA to patient without contra-indication to surgery will depend on the efficacy of the technique.

The main objective of the study is to evaluate the local efficacy of the ablation based on the technical success, and on the evaluation of local cancer recurrence over 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with percutaneous RFA
* Patient with diagnosis of renal masses with a maximum of 3 masses treated during the ablation
* The diameter of the tumor must be ≤ 40 mm, characterized by CT-scan or MRI
* The histology of the tumor must be biopsy-proven or the patient must have previous surgical ablation of renal tumor (ipsi or contralateral)

Exclusion Criteria:

* Patient treated by surgery or laparoscopy
* Benign tumors
* No histological diagnosis (no biopsy or no previous treated renal carcinoma)
* Patient having secondary malignant sites, ganglions or visceral metastatic cells or endo-venous extend at the time of RFA
* Patient having a diagnosis of primary or secondary extra-renal tumor location and not into remission
* Patients treated with antiangiogenic drugs during the 6 months prior RFA.
Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis

Leukotrienes play critical roles in the inflammatory process in allergic rhinitis and bronchial asthma, therefore, anti-leukotriene therapy is part of treatment for asthma. However, not all allergic rhinitis accompanied with or without asthma treated with anti-leukotriene were effective. So it is critical to develop a method to identify the response subgroup. In this study, it is assumed that nasal physiological responsiveness to leukotriene nasal provocation test (NPT) is able to gain evidence on the effect of leukotriene on the development of allergic rhinitis and asthma, and is helpful to the use of anti-leukotriene agent. The purpose of the study is to establish the methodology and diagnostic value of leukotriene D4 (LTD4) nasal provocation.

Nasal provocation test induced by LTD4 will be conducted by measuring nasal airway resistance and airway symptoms in a stepwise concentration of LTD4 by nasal spray. Inflammation biomarkers, such as eosinophilic granulocyte in sputum and nasal lavage, fractional exhaled nitric oxide(FeNO), and lung function before and after nasal provocation will be studied to explore the impact of LTD4 nasal provocation test on airway inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with allergic rhinitis accompanied with or without asthma
* positive skin prick test (SPT)
* had no acute upper or lower airway infection 2 weeks prior to study
* no oral or nasal anti-histamines
* no leukotriene receptor antagonists for 1 week
* no oral or nasal and inhaled corticosteroids for 2 weeks

Exclusion Criteria:

* smokers
* a past confirmed history of chronic respiratory disease other than asthma
* other severe systemic diseases (myocardial infarction, malignant tumor, etc.)
* under immunotherapy
* unable to complete the test or had limited understanding
* pregnancy
Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation

The purpose of this project is to examine the impact of increases in brain insulin on sympathetic nervous system activity, as well as peripheral and cerebral blood flow in humans.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult men and women;
* 18-45 years of age;
* BMI \>18 kg/m2;
* non-pregnant/non-breastfeeding;
* non-nicotine users;

Exclusion Criteria:

* taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic

Self-reported history of:

* hepatic, renal, pulmonary, cardiovascular, or neurological disease;
* stroke or neurovascular disease;
* bleeding/clotting disorders;
* sleep apnea or other sleep disorders;
* diabetes;
* smoking;
* history of alcoholism or substance abuse;
* hypertension;
* respiratory disease;
* active cancer;
* autoimmune disease.
Assess the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo

The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.

This study is a phase II/Ⅲ seamless adaptive clinical trial to evaluate the efficacy and safety of SHR0302 ointment in adult patients with non-segmental vitiligo.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who voluntarily signed an informed consent form.
2. Ages at ≥18 and ≤ 65 years
3. Clinical diagnosis of non-segmental vitiligo.
4. All women and men who are likely to give birth must be willing to use at least one efficient method of contraception from the signing of the informed consent form to 1 month after the last dose of IP.
5. Subjects who agree to discontinue all vitiligo-related treatments and camouflage cosmetics with therapeutic effect between screening visit and the last follow-up visit.
6. Subjects who are willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedures.

Exclusion Criteria:

1. Subjects who were diagnosed with segmental vitiligo, mixed vitiligo or unclassified vitiligo.
2. Subjects with historical or current evidence of clinically significant disease or lab test abnormalities or with disease that require the administration of prohibited drugs in this study.
3. Subjects with a malignant tumor or a history of malignant tumor (except for fully treated or resected skin non-metastatic basal cell carcinoma or squamous cell carcinoma).
4. Pregnant or lactating female subjects;
5. Subjects who have previously received JAK inhibitors therapy, systemic or oral
6. Subjects who had used any biologics within12 weeks before the baseline or 5 half-lives (whichever is longer).
7. Subjects who participated in other interventional clinical studies within 4 weeks before the baseline visit, or who were still within 5 half-lives of the last dose of the intervention clinical study drug at baseline.
8. Subjects who received a live or live-attenuated vaccination within 8 weeks before the baseline visit.
9. Any other condition that causes the subject to be unfit for the study as per discretion of the investigator.