cyrilzakka/clinical-trials huggingface dataset:
Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Thalamic Ventral Intermediate as adjunctive therapy for alleviating symptoms in refractory familial cortical myoclonus with epilepsy.

This project aims to include 5 participants, and evaluate the effectiveness and safety of Thalamic Ventral Intermediate electrical stimulation in patients with refractory familial cortical myoclonus with epilepsy through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with refractory familial cortical myoclonus with epilepsy with alternative treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Aged 30-70, meeting the diagnostic criteria for Refractory Familial Cortical Myoclonus with Epilepsy (FCMTE), meaning that tremors and/or seizures have not significantly improved despite long-term, stable use of current treatment medications, regardless of gender.
* Tremors and seizures severely impact the patients\&#39; work and quality of life.
* Experiencing drug resistance or intolerable adverse reactions to medication.
* After being adequately informed about the nature and risks of the study, willing to provide written informed consent before participating in any study-related procedures.
* Willing to adhere to the relevant trial protocol and regulations, including attending follow-up visits and undergoing related examinations within the specified timeframe.

Exclusion Criteria:

* Patients with FCMTE whose symptoms are essentially controlled after standardized medication and other treatments.
* Presence of structural abnormalities in the VIM (ventral intermediate nucleus).
* Presence of an implanted electrical stimulator (e.g., pacemaker, spinal cord stimulator, repetitive nerve stimulator) or metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagus nerve stimulation (with stable parameters for at least 3 months) is not an exclusion criterion.
* IQ \&amp;lt; 55, severe cognitive impairment that prevents participation in the study.
* Pregnant individuals or those planning to conceive within 2 years.
* Presence of progressive neurological diseases such as brain tumors, arteriovenous malformations, or cavernous hemangiomas.
* Presence of other serious neuropsychiatric disorders such as dementia, severe depression (hospitalized in a psychiatric facility within the past 5 years or any suicidal or self-harming tendencies), schizophrenia, or neurodegenerative diseases. Resolved postictal psychiatric or behavioral abnormalities are not an exclusion criterion.
* Conditions that may increase the risk of seizures during or after surgery (e.g., coagulation disorders) or require long-term oral anticoagulants or antiplatelet drugs.
* Other severe physical illnesses, psychiatric disorders, internal diseases, or severe liver or kidney dysfunction; participation in other clinical trials within the past three months.
Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.

Tenalisib is a highly specific and orally available dual PI3K δ/γ inhibitor. Pre-clinical experiments demonstrated that Tenalisib is highly effective in killing primary CLL cells in vitro. A Phase II study is planned to evaluate the efficacy and safety of Tenalisib in patients with relapsed/refractory CLL.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnosis of B-cell CLL
2. Disease status defined as refractory to or relapsed after at least one prior therapy.
3. Presence of measurable lymphadenopathy presence of \> 1 nodal lesion
4. ECOG performance status ≤ 2.
5. Adequate bone marrow, liver, and renal function

Exclusion Criteria:

1. Richter's (large cell) transformation, or PLL transformation.
2. Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
3. Prior exposure to drug that inhibits PI3K
4. Patient with ASCT/Allo-SCT receiving treatment for active GVHD.
5. Ongoing severe systemic bacterial, fungal or viral infection.
6. Central nervous system (CNS) involvement of leukemia or lymphoma.
7. Ongoing immunosuppressive therapy including systemic corticosteroids.
8. Known history of severe liver injury as judge by investigator.
9. Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
10. Women who are pregnant or lactating.
11. Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV) infection iv. active CMV infection

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Efficacy of Higher Dose Enteral Vitamin D Supplementation in Preterm 28 - 34 Weeks of Gestational Age

The goal of this clinical trial is to learn about the effective dosage of enteral vitamin D supplementation in preterm infants with gestational age fom 28 to 34 weeks. The main questions it aims to answer is:

- Does higher dose of enteral vitamin D supplementation (800IU/day) increase vitamin D level better than standard recommended dose (400IU/day) to achieve sufficient level of vitamin D?

Participants will:

* Take the enteral vitamin D supplementation every fay for 28 days
* Have their blood level of vitamin D examined before and after supplementation for 28 days

The study conducted in 2 hospitals in Jakarta region, RSCM and RSUD Koja. Preterm with 28 to 34 weeks of gestational age and fulfill the inclusion criteria will be enrolled in the study after parents signed the informed consent.

Blood sample will be collected to get the baseline of vitamin D serum. The study subject will be given enteral vitamin D supplementation for 28 days (4 weeks). The dosage of vitamin D is randomized with block randomized in sealed envelope.

Subjects then will be followed up to 28 days of supplementation. After 28 days of supplementation, the subjects' blood will be collected to get the vitamin D serum level. Data taken will be analyzed using IBM Statistical Product and Service Solutions (SPSS).

Eligibility Criteria:
Inclusion Criteria:

* neonates with gestational age 28-34 weeks
* tolerated enteral feedings more than 30ml/kg

Exclusion Criteria:

* infants with major congenital anomaly
* infants with gastrointestinal obstruction
* infants with congenital renal failure
* infants with cholestassis
Effect of Kinesio-taping Technique on Oral Feeding in Late Preterm Infants

Difficulty in feeding among late preterm infants is one of the most significant factors contributing to prolonged hospitalization and re-admissions. By providing support to the sucking and swallowing muscles early in their development, the maturation process can be expedited, allowing for the safe early discharge of preterm infants.

This study aims to investigate the effects of the Kinesio taping technique on feeding muscles and assess feeding and swallowing function in late preterm infants using acoustic analysis of swallowing sounds.

Problems such as poor nutrition, weak sucking, lack of suck-swallow-respiration coordination, low weight gain are among the factors increasing the risk of morbidity in late preterm infants. Early support of sucking and swallowing muscles for the development of suck-swallow coordination can shorten the maturation process and provide early discharge of late preterm infants. The aim of this study is to document kinesiotape technique to support sucking and swallowing muscles for treating nutritional problems and for reducing nutrition risks and accelerating maturation. According to power of analysis of this study, 74 infants planned to assign to kinesiotaping group or control group randomly. In kinesiotaping group, infants feeding performance will be evaluated by measuring the amount of milk invested, maximum heart rate, oxygen saturation, speed of milk intake and counting the number of swallow during feeding. Kinesiotape will be applied to masseter and hyoid muscles 24 hours later after the birth of the infant. Infants will be evaluated before kinesiotape application, 3 hour later and 24 hour later after the application.

Eligibility Criteria:
Inclusion Criteria:

* Infants born in Baskent University Ankara Hospital,
* age between 34-36.6 weeks

Exclusion Criteria:

* Infants with multiple kongenital anomaly,
* hypoxic ischemic encephalopathy,
* intraventricular and intracranial hemorrhage,
* necrotizing enterocolitis,
* tracheoesophageal fistula,
* diaphragmatic hernia,
* hydrocephalus,
* respiratory distress.
Cardiovascular Registry of Atrial Fibrillation

Follow a representative sample of Latin American patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death

Patients will be followed 6 months and 1 year after the baseline visit and will be collected data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic therapy and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years-old that signed informed consent;
* Atrial Fibrillation or Atrial Flutter at the time of inclusion documented in source document;
* If the patient is not in atrial fibrillation or Atrial Flutter rhythm, s/he should have 2 electrographic records, at least 15 days apart between them, with one of them being performed within the last 6 months before enrollment (AF may be documented by 12-lead ECG, Holter monitor-24h);

Exclusion Criteria:

* Patients who did not agree to participate.
* Patients without possibility of monitoring for one year.
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole

To undertake a prospective randomized clinical study for treating retinal detachment due to myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular hole.

Retinal detachment caused by macular hole predominantly happened in high myopic eyes. This is a common type of retinal detachment in Asia and often seen in the old people aged around 50 \~ 60, mainly in female. Treatment of retinal detachment due to macular holes has changed over the years, and several methods have been described. Some surgeons have used transscleral diathermy or cryotherapy or laser photocoagulation and drainage subretinal fluid without sclera buckling, other surgeons have used radial silicone explants beneath the macular combined with cryo, diathermy or laser. This method entails the difficulty of placing sclera sutures far posterior, especially hazardous if there is a posterior staphyloma with very thin sclera. Besides the technically difficult, the extensive macular scarring caused by different coagulations limited the functional result to peripheral vision only. Because of this, it is not generally used in the initial treatment.

In 1982, Gonvers and Machemer4 proposed a new treatment technique that combined pars plana vitrectomy (PPV), partial air-fluid exchange, and face down positioning for 24 hours. Since then vitrectomy with gas tamponade become the most common procedure for retinal detachment with macular hole.

In 1984, Miyake performed a simple gas injection into the vitreous followed by a face-down position. The effective of this simplified method was then reported by many observers.But these studies may have insufficiency because of small sample, nonrandomized, no defined eligibility criteria for patients selection.

Intraocular gas tamponade with or without pars plana vitrectomy (PPV) has commonly been performed nowadays. We conducted a multicenter randomized controlled clinical trial to compare their anatomic results and visual outcomes of both surgical techniques, to estimate the efficiency of both surgical methods in the treatment of retinal detachment with myopic macular hole.

Eligibility Criteria:
Inclusion Criteria:

* retinal detachment due to myopic macular hole.
* The ability to give informed consent and to return for follow-up visit for 12 months

Exclusion Criteria:

* retinal detachment with macular hole and peripheral hole/tear
* retinal detachment with severe proliferative vitreoretinopathy
* retinal detachment with choroidal detachment or rupture
* traction retinal detachment due to retinal vascular disease
* had vitrectomy in the past
* macular hole without retinal detachment
* foveal schiesis without retinal detachment
* secondary macular hole with retinal detachment
Supraclavicular Lymph Node Dissection for Ipsilateral Supraclavicular Lymph Node Metastatic Breast Cancer

The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis.

In this study, patients with ipsilateral supraclavicular lymph node positive breast cancer were selected as research subjects. Randomized controlled method was used to study the effects of surgical dissection of supraclavicular lymph node combined with radiotherapy and radiotherapy alone on progression-free survival and overall survival of breast cancer. This RCT aims to explore the best treatment method for ipsilateral supraclavicular lymph node metastasis and to provide the basis for guiding the precise treatment of supraclavicular lymph node chain.

Eligibility Criteria:
Inclusion Criteria:

1. Previously untreated primary breast cancer with supraclavicular lymph node metastasis or supraclavicular lymph node metastasis without other metastasis within 5 years after combined therapy; The diagnostic criteria refer to the diagnostic criteria for "primary breast cancer" and "Stage pN3c" in the AJCC Guidelines published on November 8, 2018;
2. Supraclavicular lymph node metastasis was confirmed by pathology;
3. Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue;
4. Patients with primary breast cancer have no history of malignant tumors and have not received chemotherapy, radiotherapy or endocrine therapy;
5. Have at least one measurable target lesion according to RECIST criteria;
6. ECOG score ≦ 1;
7. The level of organ function must meet the following requirements: adequate bone marrow reserve: absolute counts of neutrophils (lobed and band neutrophils) ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 9 g/dL. Liver: Bilirubin \<1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3.0 times the upper limit of normal. Renal: Creatinine clearance ≥ 45 mL/min;
8. No distant metastases were found in preoperative imaging examination of whole abdominal color ultrasound, chest CT or MRI, bone scan, or PET/CT;
9. normal mind, can cooperate to complete the treatment;
10. Expected survival ≥36 months
11. In accordance with the requirements of the Ethics Committee, there is an informed consent signed by the patient or her legal representative, or an informed consent signed by the patient and her family.

Exclusion Criteria:

1. The range of metastasis exceeds the neck IV and VB region;
2. En-bloc resection cannot be achieved;
3. Patients with heart, lung, vascular and other diseases cannot receive antitumor therapy;
4. Preoperative examination found distant metastasis;
5. Pregnant, lactating or inflammatory breast cancer patients;
6. Diseases associated with immune, endocrine or cardiovascular systems;
7. Previous history of other tumors or combined with other tumors;
8. Refusing to comply with the study protocol and refusing to sign the informed consent
Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer

To evaluate the efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine, and immune maintenance therapy in patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy, with a view to providing an effective treatment regimen for these patients.

Patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy are enrolled to receive concurrent chemoradiotherapy with oral vinorelbine, and immune-maintenance therapy. The primary endpoint is objective response rate, and secondary endpoints include disease control rate, progression-free survival, compliance and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥40 years old.
2. Patients must have histologically or cytologically confirmed non-small cell lung cancer.
3. ECOG PS was 0 or 1.
4. Adequate organ and bone marrow function is present. Absolute neutrophil counts, platelet counts, and hemoglobin criteria must not be met after blood transfusion or growth factor support within 14 days prior to randomization.

Exclusion Criteria:

1. History of allogeneic organ transplantation.
2. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease \[Colitis or Crohn's disease\], diverticulitis \[other than diverticulitis\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \[granulomatous vasculitis, Graves' disease, rheumatoid arthritis, pituitaritis, uveitis\]).
3. There is uncontrolled serious underlying diseases, including active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal disease.
4. History of another primary malignancy.
5. History of active primary immunodeficiency.
6. Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
7. For any unmitigated toxicity during pre-study chemoradiotherapy. Patients who develop irreversible toxicity and are reasonably expected not to worsen after study treatment (such as hearing loss) may enter the study after consultation with the study physician.
8. Patients who developed ≥ grade 3 pneumonia during study chemoradiotherapy.
9. Received any other concurrent chemotherapy, immunotherapy, biotherapy, or hormonal therapy for cancer other than the therapy evaluated in this study.
Developing Oral LT3 Therapy for Heart Failure - HFrEF

Investigation of the safety, feasibility, and preliminary efficacy of thyroid hormone therapy with Liothyronine (LT3) in individuals with heart failure with reduced ejection fraction (HFrEF) and low triiodothyronine (T3) syndrome by conducting a randomized, double-blind, placebo-controlled cross-over study with a two-week washout period between treatments.

The overall goal is to determine the safety, feasibility, and preliminary efficacy of administering oral LT3 therapy in the study population of participants with Heart Failure with reduced ejection fraction (HFrEF). The study will consist of two treatment periods - each treatment period will be approximately 8 weeks in duration, with weekly titration of study drug for 4 weeks, followed by a maintenance dose for 4 weeks, then 2-week washout before crossing over to the other arm (placebo or drug). LT3 will be titrated to T3 levels.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged ≥18 years
2. NYHA Class I, II or III heart failure
3. EF≤40 percent within the past year
4. An implantable cardioverter-defibrillator (ICD)
5. Stable doses of neurohormonal blockade for 30 days
6. TSH and free T4 level within the laboratory reference range and total T3 level \<94 ng/dL

Exclusion Criteria:

1. Hypertrophic or restrictive cardiomyopathy
2. Uncorrected severe primary valvular disease
3. Arrhythmia that results in irregular heart rate
4. Inability to perform VO2max exercise testing
5. Severe lung disease, including treatment with oral steroids within past 6 months for exacerbation of obstructive lung disease or use of daytime supplemental oxygen
6. Serum creatinine \> 3.0 mg/dL
7. History of cirrhosis
8. LVAD use
9. Heart failure hospitalization within past month
10. Acute coronary syndrome, coronary intervention or ablation therapy within past 2 months or cardiac surgery, percutaneous repair of a valve or septal defect repair within the past 6 months
11. Taking thyroid extract, LT4, LT3, amiodarone, or medication that affects the absorption or metabolism of thyroid hormone; gastrointestinal conditions that affect the absorption of thyroid hormone
12. If female, current or planned pregnancy within the timeframe of study participation
13. Any medical condition that in the opinion of the investigator, will interfere with the safe completion of the study.
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Healthy Postmenopausal Women

Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed for treatment of menopause. The purpose of this trial is to compare a new manufacturing process for making BZA/CE to the current process by assessing the way it is absorbed into the blood.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 35 to 70 years
* Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg
* Healthy as determined by the investigator on the basis of medical history, physical examination, breast and gynecologic examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* Any clinically important active condition of gynecologic, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
* History of any clinically important drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs).