cyrilzakka/clinical-trials huggingface dataset:
Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease

Study the therapeutic effect and potential neural mechanisms of cerebellar iTBS mode transcranial magnetic stimulation on Alzheimer's disease patients through MRI and EEG.

This study intends to apply intermittent therapy for the first time θ The Outbreak Stimulation (iTBS) mode was used for rTMS treatment in the cerebellum of Alzheimer's disease (AD). This was a randomized, double-blind, parallel, and sham stimulation controlled clinical trial, which included 28 AD patients. All patients were randomly divided into the iTBS group and the sham stimulation group. Collect clinical information, scales, magnetic resonance imaging, TMS synchronous electroencephalography, polysomnography monitoring, etc., and then perform TMS/false stimulation treatment on subjects for 4 weeks (a total of 20 times); After treatment and one month follow-up, relevant scales, magnetic resonance imaging, TMS synchronous electroencephalogram and other data were collected again, and appropriate statistical methods were used to analyze the therapeutic effect.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 45-80 years old;
2. Meets the NIA-AA standards established by the National Institute on Aging in the United States; Cerebrospinal fluid presents as A β decrease and increase tau protein.

3 The MMSE score ranges from 18 to 26, and the Clinical Dementia Rating (CDR) score is 0.5 to 1 4 At least one adult caregiver 5 patients have received treatment with acetylcholinesterase inhibitors (AChEI) or memantine, such as donepezil, galantamine, or gabalin

* Medication for at least 3 months
* The current dosing regimen remains stable for 8 weeks
* The medication plan remains stable throughout the entire process 6. At least 8 years of educational experience 7 Patients and their families voluntarily sign informed consent forms

Exclusion Criteria:

1. Central nervous system degenerative diseases other than Alzheimer's disease
2. Previous history of epilepsy (excluding febrile seizures in childhood)
3. According to the Diagnostic and Statistical Manual of Mental Disorders, the Fourth Edition - Text Revised Edition (DSM IV-TR) standard meets any of the following:

   * Depression (currently)
   * Schizophrenia
   * Other psychiatric disorders, bipolar disorder, or substance dependence (including alcohol) (within the past 5 years)
4. Cerebrovascular disease (excluding lacunar infarction), severe infection, malignant tumor, accompanied by severe dysfunction of organs such as heart, liver, and kidney
5. There are contraindications for transcranial magnetic stimulation and MRI, or there are metal or implanted devices in the body, such as pacemakers, deep brain stimulators, etc; 6 Use any of the following medications for treatment within the past 3 months:

   * Typical and atypical antipsychotic drugs (such as clozapine, olanzapine)
   * Antiepileptic drugs (such as carbamazepine, topiramate, sodium valproate) 7 has received TMS treatment in the past 8 Participate in clinical trials of any drug within 6 months prior to study registration
The Community United to Challenge Asthma

This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education in high-risk Puerto Rican children in elementary school. The primary outcomes are asthma medication adherence and trigger reduction.


Eligibility Criteria:
Inclusion Criteria:

* Puerto Rican
* In elementary school
* Diagnosed with asthma

Exclusion Criteria:

* Not in school
* Mild intermittent asthma
* Well controlled asthma
Peripheral Blood Biomarkers Associated With CIPN

The investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy.

The investigators are asking for a blood sample, information about patients symptoms during chemotherapy, and past medical history from people who have taken or will take certain types of chemotherapy. The investigators hope to examine blood for proteins that could help us learn which patients get neurological symptoms while getting chemotherapy. The investigators' main research goal is to improve the treatment of patients getting chemotherapy to help their quality of life and/or help to increase the chance of their cancer being cured.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a tumor for which Platinums, Vinca Alkaloids, Bortezomib or Taxanes are indicated
* No prior history of diabetic, anatomical or regional neuropathies (except pre-existing CIPN)
* Age ≥ 18 years
* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.

Exclusion Criteria:

* Inability to give consent
* Inability to tolerate venipuncture for any reason
* Age \< 18 years
* Any known medical, surgical or psychiatric condition that may interfere with the conduct of the study or be detrimental to the donor in the opinion of the PI or caring physician
* Consent Refusal by patient
Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device Insertion(IUD).

The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.

Various studies evaluating the use of local anesthetics or misoprostol prior to IUD insertion have mixed results.We think that the combination of diclofenac and lidocaine gel could be more successful in relieving pain during IUD insertion than single therapy.The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.

Eligibility Criteria:
Inclusion Criteria:

* Patients of reproductive age requesting IUD for contraception

Exclusion Criteria:

* Patients with contraindications to IUD insertion ( less than 6 weeks postpartum, less than 2 weeks after abortion, uterine anomalies, fibroid distorting uterine cavity, pregnancy, pelvic inflammatory disease, cervicitis, uterine depth less than 6 cm or more than 9 cm) , previous IUD insertion, allergy to diclofenac or lidocaine, peptic ulcer , asthma, bleeding disorders, cardiac, liver or kidney diseases.
Effects of a Multi-intervention Programme for the Elderly

1. To develop a multiactivity training programme. 2. To explore the effect of this programme on sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease. 3. To compare the effects of the experimental and control treatments on the muscle strength, body composition, physical function performance and quality of life of the elderly.


Eligibility Criteria:
Inclusion Criteria:

(1) over 60 years old, (2) able to Communicate and follow instructions; (3) Stable condition with sufficient physical strength: able to maintain a seated position in a wheelchair or on the edge of a bed for at least one hour. (4) sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease.

Exclusion Criteria:

(1) difficulty in standing or walking and obvious musculoskeletal disease, (2) unsuitable for diagnosis by a physician those engaged in sports activities, (3) serious diseases/unstable states, such as severe heart, lung, liver and kidney diseases, severe malignant tumors, severe nutrition poor, severe dementia, (4) more than 180 minutes of exercise per week in the past month, (5) no willingness to participate.
Study on Allopregnanolone and Depression in Women Across the Menopause Transition

This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.

Midlife women are burdened with depression risk that is at least partly attributed to changing reproductive steroid dynamics across a prolonged reproductive transition. We hypothesize that declining endogenous allopregnanolone (ALLO) levels across the menopause transition underlies perimenopausal depression. This mechanistic trial aims to amplify the contrast between lower endogenous ALLO levels in perimenopausal women and higher levels induced by pregnenolone. This will be achieved by using the over-the-counter dietary supplement, pregnenolone, in a randomized, double-blind, parallel-arm, placebo-controlled trial. By manipulating ALLO levels together with key measurement of depression domains, this study harnesses the endocrine biology of perimenopause to explicate behavioral and neurobiological mechanisms underlying depression in women across the menopause transition.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women ages 40 to 60 years in the menopause transition
* Depressive symptoms
* Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
* Able to read Arabic numerals and perform simple arithmetic
* Able to provide written informed consent

Exclusion Criteria:

* Systemic hormone therapy
* Contraindicated medications with pregnenolone
* Systemic corticosteroid
* Other psychiatric illnesses that are considered to be primary
* Current suicidal ideation
* Active substance use disorders
* Unstable medical conditions
* Obstructive sleep apnea or other primary sleep disorders
* Abnormal hepatic and renal function
* Known allergy to progesterone, exogenous allopregnanolone, or pregnenolone
* History of head injury resulting in loss of consciousness \> 20 min
* Inability to comply with barrier contraceptive methods
* Known intellectual disability
* Investigator judgement that study participation constitutes substantial risk given medical or psychiatric condition
* Current or recent participation in clinical trial expected to interfere with risk of or interpretation of study data
* Inability to comply with study procedures
A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)

This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject has been a nonsmoker for at least 6 months
* Subject is willing to avoid strenuous activity from the screening visit until the end of the study
* Subject agrees not to consume grapefruit products during the study and to avoid all fruit juices 24 hours before and after study drug administration

Exclusion Criteria:

* Any history of stroke or neurological disorder
* Subject has a history of cardiovascular, blood, endocrine or liver diseases
* Subject has a history of cancer
Coagulation System In STereotactic Radiotherapy Of NSCLC

The risk of thromboembolism is elevated in lung cancer patients. The present project investigates whether stereotactic body radiation therapy (SBRT) further increases the risk of thromboembolic disease in lung cancer patients.

If coagulation is activated by SBRT, this study could form the basis of new clinical trials investigating whether lung cancer patients may benefit from thromboprophylaxis during and after stereotactic body radiation therapy.

In this study, the patients will have blood samples drawn three times (prior to start of stereotactic body radiation therapy, immediately after stereotactic body radiation therapy completion, four to six weeks after completing stereotactic body radiation therapy). The blood sample at the completion of stereotactic body radiation therapy is an extra compared to normal gathering of blood samples of patients with NSCLC treated with stereotactic body radiation therapy. Also extra glasses with blood will be gathered at each blood sample for storage in a biobank in order to be able to make future analysis on this material.

There is a minimal risk of developing infection or hematoma in connection with blood sampling but we consider this risk to be negligible. The total volume of 120 ml blood drawn over a period of 6 weeks is an inconsiderable risk for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Planned stereotactic body radiation therapy of lung cancer

Exclusion Criteria:

* Inability to provide informed consent
* Venous thrombosis within the last three months
* Active cancer within the previous year except for lung cancer
The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis

To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis

This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.

Eligibility Criteria:
Inclusion criteria

1. Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3)
2. Without heart, liver, kidney, endocrine and other major organic diseases (patient return)

Exclusion criteria

1. With heart, liver (GOT and GPT values are 3-fold higher than the standard maximum), kidney (estimated creatinine clearance less than 25 mL/min), endocrine and other major organic diseases (patient return)
2. People with mental illness
A PK Study GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers

Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers

GL2702 GLARS-NF1 tablet is controlled released formulation which is invented by GL Pharm Tech Corp.

Eligibility Criteria:
Inclusion Criteria:

* 20\~45 years old, Healthy Adult Male Subject
* Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

* ALT or AST \> 1.25 times (Upper Normal Range)
* Total Bilirubin \> 1.5 times (Upper Normal Range)
* CPK \> 2 times (Upper Normal Range)
* BUN or Creatinine \> Normal Range
* Systolic BP \> 160mmHg or \< 80mmHg, Diastolic BP \> 100mmHg or \< 50mmHg
Evaluation of A-1 Cool Cream Efficacy for Treatment Atopic Dermatitis

Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 20% of all babies and children around the world. Diagnosis of atopic dermatitis is clinical and depends on the existence of at least two out of the four following criteria: itching, a chronic disease course with exacerbations and remission ,rash with characteristic distribution and shape , atopia of the patient or family by history.

Initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and allergens. The research product A-1 COOL is a skin cream approved by the Israeli Ministry of Health for cooling down of skin irritation. A-1 COOL is rich in herbal medicine ingredients and does not contain steroids.A-1 COOL can be beneficial in Atopic Dermatitis patients due to its following action mechanisms: sealing of the inflamed skin and retention of water, prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the herbal ingredients.

Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 20% of all babies and children around the world. In 90% of the cases the disease first appears before the age of five and in 65% of the cases it is already apparent at infancy but it may occur at any age.

Diagnosis of atopic dermatitis is clinical and depends on the existence of at least two out of the four following criteria: itching, a chronic disease course with exacerbations and remission ,rash with characteristic distribution and shape , atopia of the patient or family by history.

Initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and allergens. Topical ointments which grease the skin have shown and reduction of skin inflammation. These products can include active substances such as steroids and anti-inflammatory compounds.

Systemic treatments for atopic dermatitis mainly include steroids and cyclosporine.

The research product A-1 COOL is a skin cream approved by the Israeli Ministry of Health for cooling down of skin irritation. A-1 COOL is rich in herbal medicine ingredients and does not contain steroids.A-1 COOL can be beneficial in Atopic Dermatitis patients due to its following action mechanisms: sealing of the inflamed skin and retention of water, prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the herbal ingredients.

Eligibility Criteria:
Inclusion Criteria:

* patient with atopic dermatitis,
* Hebrew-speaking men and women,
* over 18 years old.

Exclusion Criteria:

* hospital where the diagnosis of atopic dermatitis is not sure,
* patients under the age of 18, pregnant women, no - helpless, soldiers and prisoners,
* patients with atopic dermatitis treated with systemic preparations such as cyclosporine, steroids, antibiotics, methotrexate, biological preparations.
EndoPredict® Extended Endocrine Trial (EXET)

The purpose of this study is to evaluate the impact of using EndoPredict® clinically to inform treatment decisions for extended endocrine therapy, and the subsequent impact on patient outcomes.

The EndoPredict® molecular test is validated to predict late distant recurrence after 5 years of endocrine therapy in women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early stage breast cancer, with or without treatment with adjuvant chemotherapy. The test provides an individualized EPclin score based on the tumor gene expression, tumor size and nodal status, and categorizes patients as High or Low risk of distant recurrence.

The primary objective of this study is to evaluate the distant recurrence-free survival (DRFS) at 5-10 years in patients with ER+/HER2- early stage breast cancer with EPclin Low scores that did not extend endocrine therapy.

Data collection is prospective and patient enrollment is expected to occur over 24 months. The study will enroll patients who are near the 5-year post-diagnosis time point when decisions on extending endocrine therapy are being made. Patient breast cancer tumors, stored from surgical collection after initial diagnosis, will be tested with EndoPredict and a report generated. The provider will convey the report results to the patient and establish a treatment plan to continue or forgo endocrine therapy. Patients will then be followed for 6 years with data collection every year, and outcomes (distant and local disease recurrence, second primary breast cancer, etc.) recorded.

The associations between outcomes and treatment, EPclin score and risk category, EP molecular score, and clinicopathologic features will be investigated in all patients and in subpopulations (node negative, node positive, treated with or without chemotherapy, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Female
* At least 18 years of age at time of enrollment
* Able to provide informed consent
* ER+, HER2- breast tumor
* Stage T1-T3
* Currently receiving endocrine therapy
* Are between 4 and 6.5 years post-invasive breast cancer diagnosis
* Have all available information to produce an EPclin score, including treatment-naïve tumor stage, nodal status, and sufficient amount of remaining tissue from biopsy or resection to perform genomic testing (section 9)
* Patient and physician are willing to consider a change in endocrine therapy

Exclusion Criteria:

* Metastatic disease or currently active additional cancer diagnosis (except non- melanoma skin cancer) or any second primary breast cancer (includes ductal and/or lobular carcinoma in situ)
* Patient received systemic chemotherapy within 1 year of enrollment
* Currently enrolled in an interventional clinical trial or other clinical trial that precludes freely making decisions regarding extended endocrine therapy
* More than 3 positive nodes
* Received neo-adjuvant treatment (new-adjuvant chemotherapy or neo-adjuvant endocrine therapy)
* Are beyond 7 years post-breast cancer diagnosis
Clinical Research of ROBO1 Specific CAR-NK Cells on Patients With Solid Tumors

Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. We have developed anti-ROBO1 CAR-NK cells that can target tumor cells highly expressing ROBO1. The purpose of this study is to evaluate the safety and effectiveness of cell therapy using ROBO1 CAR-NK cells to treat solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 \~ 75 years old, male or female
2. Life expectancy ≥ 6 months
3. ECOG score: 0 - 3
4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
5. Advanced solid tumor was diagnosed by pathological or clinical physicians
6. Laboratory examination: white blood cell ≥ 3 x 10\*9/L, blood platelet count ≥ 60 x 10\*/L, hemoglobin ≥ 85g/L; lymphocyte count ≥ 15%, total bilirubin ≤ 100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level
7. Signed informed consent
8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion

Exclusion Criteria:

1. Expected overall survival \< 6 months
2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months
3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%
4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements
IBI397 or Combination Therapies in Patients With Advanced Malignancies

The primary objective of this phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or its Combination Therapies in Patients with Advanced Malignancies


Eligibility Criteria:
Inclusion criteria:

* Have failed the standard treatment for locally advanced, recurrent or metastatic solid tumor or have failed at least the second line standard treatment (including autologous stem cell transplantation) or have failed the first line standard treatment and are not eligible for autologous stem cell transplantation
* Willing to and able to provide written informed consent for the trial and able to comply with protocol-specified visits and related procedures
* ≥ 18 and ≤ 75 years of age on the day of signing the informed consent
* Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS)
* Subjects with solid tumor: Have at least one measurable or assessable lesion as defined by RECIST v1.1; Subjects with lymphoma: Have at least one measurable or assessable lesion as defined by Lugano2014 criteria

Exclusion Criteria:

* Has been previously exposed to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein or other inhibitors that target the same pathway
* Is currently participating in another interventional study, except for observational (non-interventional) study or in the survival follow-up phase of an interventional study
* Requires long-term systemic hormone or any other immunosuppressive drug therapy, excluding inhaled hormone therapy
* Has acute or chronic active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] and/or hepatitis B core antibody positive \[HBcAb\] and hepatitis B virus \[HBV\] DNA copy number ≥ 1 × 104 copies/ml or ≥ 2000 IU/ml or higher than the lower limit of detection) or acute or chronic active hepatitis C virus (HCV) antibody positive; HCV antibody positive but RNA negative subjects are allowed
* Has a known history of severe allergic reaction to other monoclonal antibodies, or is allergic to any component of the IBI397 formulation.
* Is pregnant or breastfeeding