cyrilzakka/clinical-trials huggingface dataset:
Hypomethylating Agents and Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy

This is a retrospective, observational, monocentric study to evaluate the efficacy and safety of the combination of an hypomethylating agent with venetoclax newly diagnosed patients with acute myeloid leukemia ineligible for intensive chemotherapy

The prognosis of acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy is poor (Kantarjian et al). Hypomethylating agents, azacitidine and decitabine, are effective and less toxic regimens, and treatment with these agents has improved the prognosis of these patients (Fenaux et al).

Venetoclax, a Bcl-2 inhibitor, in combination with azacitidine has shown efficacy in AML patients with complete remission rate of 73% and overall survival at 2 years of 40-50% (Di Nardo et al).

On these grounds, the aim of this study is to collect the real-life experience with this combination in previously untreated AML patients.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* newly diagnosed acute myeloid leukemia not eligible for intensive chemotherapy

Exclusion Criteria:

* promyelocytic acute myeloid leukemia
* patients who have already received one or more prior lines of therapy
Clinical Phenotypes of COPD Patients Between in Plateau and Plain

We aimed to collect clinical and radiological data of patients with stable COPD in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.

The purpose of this study was to investigate the clinical phenotypic characteristics and imaging features of patients with stable chronic obstructive pulmonary disease (COPD) in plateau and plain. We conducted a cross-sectional study, collecting clinical data of stable patients in plateau and plain, and comparing the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and had definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC)\<0.7.

Exclusion Criteria:

* age \<40 years;
* subjects with airway diseases other than COPD;
* acute exacerbation of COPD in the past 3 months;
* active tuberculosis;
* cardiovascular or cerebrovascular events in the past 3 months;
* cognitive dysfunction such as vascular dementia or Alzheimer's disease;
* refusal to participate in this study.
FS120 Phase 1/1b Study in Patients With Advanced Malignancies

This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies


Eligibility Criteria:
Inclusion Criteria:

* Measurable disease
* Eastern Cooperative Oncology Group Performance Status 0-1.
* Highly effective contraception if risk of conception exists
* A female subject is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception
* Subjects with HIV who are healthy and how a low risk of acquired immunodeficiency syndrome related outcomes
* For combination part: Subjects must have histologically confirmed locally advanced, unresectable or metastatic solid tumours where there is regulatory approval for use of pembrolizumab as a monotherapy agent

Exclusion Criteria:

* Prior systemic anticancer therapy within 28 days or 5- half-lives, whichever is shorter, before the first dose of study drug.
* Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or CD27 targeting therapy (single agent or combination).
* Prior radiotherapy within 2 weeks of start of study treatment.
* HIV infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
* Uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis, primary CNS tumours, or solid tumours with CNS metastases as the only measurable disease.
* Prior history of any grade ≥3 immune-related AE (irAE) that has not improved to grade ≤1; any grade ≥3 irAE that resulted in discontinuation of treatment, significant (grade ≥3 NCI CTCAE Version 5.0) treatment-related cytokine release syndrome.
* Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade ≥1 NCI CTCAE Version 5 toxicity related to prior therapy or any condition that would significantly impair and/or prohibit the participant's participation in the study, as per the investigator's judgement.
* Vaccination with a live vaccine within 30 days before first dose of study drug.
* Participants with a known additional malignancy that is progressing or has required active treatment in the past 3 years.
* Participants with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
A Study of IBI362 in Participants With Type 2 Diabetes

This trial is conducted in China. The aim of the trial is to evaluate efficacy and Safety of IBI362 Versus dulaglutide as add-on to Metformin and/or SGLT2 inhibitor or TZD in Subjects With Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. T2D was diagnosed according to WHO standards in 1999 for
2. Age ≥ 18 when signing the informed consent form
3. After used stable-dose metformin (≥1500 mg/day) or stable-dose metformin (≥1500 mg/day) combined with SGLT2 inhibitors (empagliflozin 10 mg/day, dapagliflozin 10 mg/day, canagliflozin 100 mg/day, Henagliflozin 5 mg/day) for 2 months before screening, or stable-dose metformin (≥1500 mg/day) combined with daily fixed-dose sulfonylureas (half the maximum dose on the drug label), the blood sugar was still poorly controlled, the local laboratory test at the time of screening was 7.5%≤HbA1c≤11.0%.
4. BMI≥23 kg/m2 at screening.
5. Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol

Exclusion Criteria:

1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
2. Weight change\>5% within 12 weeks before screening (chief complaint)
3. Oral hypoglycemic drugs other than background therapy drugs have been used within 2 months before screening.
4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes
5. There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery)
6. Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study
7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
8. The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study
Brain Awake Surgery Using Virtual Reality Headset

Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral tumor or any type of brain lesion localized at the vicinity of eloquent area

Exclusion Criteria:

* Emergency
* Any contra-indication to awake brain surgery
An Interactive Program to Improve Care for Children With CF

The purpose of this study is to evaluate the impact of an internet based program for children and families (CF.DOC) with Cystic Fibrosis on health outcomes. The program provides for virtual visits, a personal health record, messaging with clinicians and several tools for monitoring self-care behaviors. We anticipate that this intervention will provide for more intensive monitoring and feedback of self-care behaviors and will lead to improved health status and in particular nutritional status

Subjects will be drawn from the pool of children who receive their care at the LPCH/Stanford Cystic Fibrosis Center. A letter will be sent to all eligible patients inviting them to participate in the study. This letter will also be available in the CF clinic. All subjects who agree to participate in the study will have the study described to them by a research assistant either in person or over the phone. Informed consent will be obtained all on subjects. Subject who elect to participate will be randomized into either an intervention group or a control group . Subjects in the intervention group will be given Internet Access to the program CF.DOC. They will also be given training in how to use the program for communication with their clinicians, participating in a virtual visit and using online forms and surveys. Subjects in the control group will be advised that they will receive usual care and will have access to CF.DOC at the completion of the study. At the beginning of the study and at 3 month intervals subjects will be asked to complete a cystic fibrosis Quality of life survey. At the beginning and end of the study all subjects will complete a patient experience questionnaire (CAPHS 2.0 CCC supplement ) and an CF.DOC evaluation survey. As part of their regular care all subjects will also have their nutritional status measured and pulmonary function assessed. subjects in the intervention group will asked to define treatment goals that are important to them (e.g. attending camp or participating in sports) and to define health measures that will help monitor progress in meeting these goals e.g. weekly weights or pulmonary function. Subjects in the intervention group will be asked to log onto CF.DOC at least one time per month.

Eligibility Criteria:
Inclusion Criteria: Patients with Cystic Fibrosis diagnosed by a sweat chloride analysis and/or testing for the CF gene between the ages of 1 month and 21 years of age. Patients must also be English speaking -

Exclusion Criteria: Non-English speaking patients

-
Amlodipine Plus Botulinum Toxin for Focal Dystonia

Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.

Study Population: 20 patients with cervical dystonia

Design: Double-bind, placebo-controlled clinical trail.

Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale, NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers: Amplitude of EDB MEP.

Objective: To determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.

Study Population: 20 patients with cervical dystonia

Design: Double-bind, placebo-controlled clinical trail.

Outcome measures: dystonia rating scales (TWISTRS)

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients enrolled in Protocol 85-N-0195, Efficacy and Pathophysiology of Botulinum Toxin for Treatment of Involuntary Movement Disorders are eligible for enrollment if they meet the following inclusion and exclusion criteria.

Good general health

Focal hand dystonia or cervical dystonia

Stable response to botulinum toxin demonstrated through a series of at least 3 injections over a period of at least a year

Benefit from the 3 immediately prior btx injections rated as 75% or less or a duration of benefit lasting less than or equal to 2 months

No other medications for dystonia

EXCLUSION CRITERIA:

Cervical dystonia accompanied by dysphagia or dyspnea, either before or with botulinum toxin injection

Present or past cardiac disease, hypertension, arrhythmia or congestive heart failure

Anterocollis or other neck dystonia requiring bilateral anterior neck muscle injections

Use of concomitant medications affecting calcium channels or those metabolized by the cytochrome p450 3A4 system including grapefruit juice, St. John's wort, HIV protease inhibitors, cimetidine, antibiotics (macrolides, fluoroquinones, antifungal, rifampin), antidepressants (fluvoxamine, norfluoxetine), barbiturates, anticonvulsants (carbamazepine, phenytoin), oral diabetes agents (pioglitazone, troglitazone), and glucocorticoids

Allergy to amlodipine or related compounds

Pregnany/ nursing

Age less than 18 years of age

Abnormal EKG

Abnormal coagulation profile or liver function tests

Use of anticoagulants
A Long-term Trial of EB-1020 in Adult Patients With ADHD

The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan


Eligibility Criteria:
Inclusion Criteria:

* Participants who completed the treatment period andfollow-up period in the preceding double-blind parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product (IMP).
* Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.

Exclusion Criteria:

* Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.
* Participants who started prohibited concomitant medications/therapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed beneficial.
* Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence:

  * Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 on the section of suicidal ideation on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blind parent trial or
  * Reported suicidal behavior
* Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.
* Participants who test positive for drugs or alcohol in a urine test on baseline visit.
Myopia-control Efficacy by Peripheral Defocus Lens (PDL)

The proposed study below aims to assess the effect of customized Bestivue PDL lenses on retinal image quality and myopia control. A total of 160 subjected would be enrolled in and randomized to allcoate into four groups. Visual acuity and image blur at various gaze directions and eccentricities on children fitted with +2 to 4 D power and single vision lenses would be measured to assess the short term effect of PDL lens. Axial length and cycloplegic objective refractive error would be measured to assess the Myopia-control Efficacy.

The proposed study below aims to assess the short-term and long-term effect of customized Bestivue PDL lenses on retinal image quality and myopia control. To these ends, two stages of testing are planned. First, objective testing will be utilized to assess the effect of Bestivue PDL lenses on visual acuity and image blur at various gaze directions and eccentricities on 4- to 13-year-old children fitted with +2 to 4 D power and single vision lenses.In the second stage, the same children participants will wear either single or Bestvue PDL lenses with one of the four plus power designs for 2 years. Their corrected visual acuity, objective refractive error with dilation and axial length will be assessed for each eye every six months for two years. Outcomes of these studies should inform whether Bestivue PDL lenses are effective in myopia control while affording adequate visual comfort and performance.

Eligibility Criteria:
Inclusion Criteria:

* The subjects had spherical RE of -1.00 to -6.00 D
* Astigmatism ≤ 4.00 D
* Anisometropia ≤ 1.50 D\\
* Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.

Exclusion Criteria:

* Strabismus
* Ocular limitations
* Systemic abnormalities affecting vision and ocular motility.
DIM as a Treatment for Thyroid Disease

Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables (such as cabbage, cauliflower, broccoli, \& Brussels sprouts) has been studied extensively in recent years for its anti-cancer effects. DIM has been shown to exert control over cancer cell growth in breast, uterine, cervical, ovarian, and colon cancer.

To date no human study has been published regarding the bioavailability of DIM in thyroid tissue or its effects in proliferative thyroid disease. Our previous study attempted to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease and ascertain its uptake in thyroid tissue. DIM has been shown to concentrate in the thyroid gland. Furthermore, thyroid volumes have been seen to decrease subjectively.

This study would continue our attempt to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults diagnosed with abnormalities of the thyroid gland suspicious for benign adenoma, or goiterous changes.

Exclusion Criteria:

* Patients who are pregnant, attempting to conceive, or lactating will be excluded due to possible deleterious effects of treatment on fetus/infant. Patients taking oral contraceptives, estrogen therapy, tamoxifin or those with a history of breast cancer will be excluded. Patients with liver disease and those taking statins for hypercholesterolemia will also be excluded to decrease the potential for possible liver toxicity. Any patient with elevated liver enzymes on pretreatment blood screening will be excluded from study participation. Patients with serious systemic diseases such as renal failure, diabetes, blood dyscrasia, coagulopathy, and non-optimized cardiopulmonary disease will be excluded due to the possibility of confounding blood tests screening for toxicity.
The SIM-SOF Trial for Hepatitis C

Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.

Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.

Must have Child's Class A cirrhosis/compensated and no history of decompensation

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis c,
* cirrhosis biopsy-proven, or via fibrotest,
* CPT score less than 7,
* genotype 1a,
* INR 2.3 or less,
* serum albumin greater than 2.7 gm/dL,
* total bilirubin less than 3 gm/dL,
* platelet count 50,000 per cubic milliliter or more
* GFR \>50 ml/min

Exclusion Criteria:

* non genotype 1a,
* history of CPT class B or C or decompensation or history of same,
* HIV or HBV coinfection,
* prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,
* uncontrolled psychiatric or cardiopulmonary disorders,
* planning pregnancy or unwilling/unable to practice contraception
The Vesalio NeVa Stent Retriever Registry Study for Treatment of Large Vessel Occlusion Strokes

A prospective, open label, 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

This is a prospective, open label, multi-center registry designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 400 subjects at up 20 sites will participate in the study.

Eligibility Criteria:
Inclusion Criteria: Only subjects already treated with the NeVa devices can be considered for enrollment.

1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:

   1.1. Subject has failed IV t-PA therapy

   1.2. Subject is contraindicated for IV t-PA administration
2. Age ≥18
3. NIHSS score ≥ 6
4. Pre-stroke mRS score of ≤ 1
5. Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA.
6. Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well \[TLKW\])
7. Imaging Inclusion Criteria:

   7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 if treatment started 0-6 hours from TLKW ASPECTS 8-10 if treatment started 6-24 hours from TLKW

   7.2. CT Perfusion core ≤50 cc

   7.3. MRI DWI core ≤50 cc
8. Subject or legal representative is able and willing to give informed consent within 48 hours after the intervention.

Exclusion Criteria:

1. Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
2. Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre- treatment pulmonary aspiration.
3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
4. Cerebral vasculitis
5. History of severe allergy to contrast medium.
6. Known allergy to NeVa materials (nitinol, stainless steel)
7. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
8. Systemic infection
9. Significant mass effect with midline shift
10. Evidence of intracranial tumor (except small meningioma)
11. Inability to deploy NeVA device for at least one pass for any other reason
12. Life expectancy less than 6 months
13. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.