cyrilzakka/clinical-trials huggingface dataset:
Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤75 years.
* Diagnosis of CML-CP.
* ECOG performance of 0-2.
* Adequate end organ function defined as the following: total bilirubin \<1.5xULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
* Resistance and/or intolerance of at least two second-generation TKIs.
* Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

* Known to be allergic to study drug ingredients or their analogues.
* History of undergone major surgery within 4 weeks.
* Patients unwilling or unable to comply with the protocol.
* Pregnant or breast-feeding patients.
* patients with other malignant tumor.
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).


Eligibility Criteria:
Key Inclusion Criteria:

* Meets the following conditions:

  * A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
  * Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
  * Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kilopascal (kPa) OR
  * A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
  * No documented weight loss \> 5% between the date of the liver biopsy and screening.
* Platelet count ≥ 150,000/mm\^3
* Albumin ≥ 3.3 g/dL
* Serum creatinine ≤ upper limit of normal (ULN)

Key Exclusion Criteria:

* Pregnant or lactating females
* Alanine aminotransferase (ALT) \> 5x upper limit of the normal range (ULN)
* Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
* Cirrhosis of the liver

  * Prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding
* Body mass index (BMI) \< 18 kg/m\^2
* Uncontrolled diabetes mellitus (hemoglobin A1c \> 9% at screening)
* International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
* Total bilirubin \> 1 x ULN, except with diagnosis of Gilbert's syndrome

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after tonsillectomy is one of the risks of this surgery and can be more dangerous in children since they have less blood volume than adults. In order to improve recovery after tonsillectomy, steroids (medication that is a strong anti-inflammatory) are often given during the surgery. Recently, a study showed steroids given at the time of tonsillectomy increase the risk of bleeding significantly over children who did not receive steroids. This finding has raised concerns in the Ear, Nose, and Throat (ENT) community since most ENT's use steroids during tonsillectomy in children. The investigators look to explore this question further.

To answer the question of whether perioperative steroid administration significantly affects the rate of post-tonsillectomy bleeding, the investigators propose to test the following hypotheses in a prospective, randomized, blinded placebo-controlled trial: dexamethasone does not cause an increase in post-operative bleeding rate in tonsillectomy.

Detailed description is entered above

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 3 to 18 undergoing tonsillectomy or adenotonsillectomy by electrocautery alone for the indication of sleep disordered breathing or infectious tonsillitis.
* Patients with complex medical conditions or craniofacial abnormalities will be included.
* Informed consent and child assent are required for enrollment.
* Eligibility will be determined by the principal investigator, associate investigator or research nurse.

Exclusion Criteria:

* Subjects with a known personal or family history of any bleeding disorder will be excluded.
* Subjects currently on oral corticosteroids for other medical conditions or have recently taken any oral corticosteroid within two weeks of surgery.
* Patients with tonsillectomy performed using a cold knife technique, microdebrider, coblation or plasma knife due to surgeon or parent preference.
* Where appropriate subjects who do not have informed consent or child assent signed will be excluded
* Children less than three years old will be excluded due to the fact the majority of these children at the collaborating centers have an adenotonsillectomy using the microdebrider for pain control purposes.
Leveraging Exercise Stress Echocardiography for Heart Failure With Preserved Ejection Fraction

The purpose of this study is to find out if additional images taken during a stress echocardiogram study and risk score calculation will help the doctor determine if shortness of breath or chest pain are caused by stiff heart (heart failure with preserved ejection fraction or HFpEF).


Eligibility Criteria:
Inclusion Criteria:

* Clinically indicated exercise stress echo for the evaluation of exertional dyspnea or chest pain
* Age ≥50 years

Exclusion Criteria:

* Known history of HFpEF
* LVEF \<50% on baseline echo study
* History of hypertrophic cardiomyopathy, amyloidosis, or pulmonary arterial hypertension, severe right ventricular dysfunction and severe valvular disease based on chart review or baseline echo study
* History of organ transplant (heart, kidney, liver, lungs)
* Severe pulmonary disease requiring ambulatory oxygen therapy
* End-stage renal disease requiring long-term renal replacement therapy
* Decompensated liver disease
* Conditions that prevent accurate assessment of E/e' ratio (mitral prosthetic valve, severe mitral annular calcification)
* Plan to use echo contrast agent during stress study (i.e. contrast agent needed for baseline study)
* Patients from outside Duke health system with no plan for long-term care at Duke
Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis

This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis.

Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.


Eligibility Criteria:
Inclusion Criteria:

* Patient has signed and dated the informed consent.
* Patient has 1- 2 documented stenotic or occluded atherosclerotic lesions (up to 18 cm long) of the above-the-knee femoropopliteal artery, that meet all of the inclusion criteria and none of the exclusion criteria.
* Reference vessel (the above-the-knee femoropopliteal artery) diameter of 4 mm to 9 mm.
* Taget lesion(s) should be accessible for stenting, as imaged with angiography (digital subtraction, MRI or CTI), i.e. proximal cm of SFA must be open
* Patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion.
* Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 (moderate claudication) or 3 (severe claudication) lasting for at least 3 months. (Positive Claudication Questionnaire)
* Exercise therapy, smoking cessation advise and best medical therapy must have been implemented at least 3 months ago and without significant clinical effect.
* Patient has a resting ABI \<0.9 or an abnormal exercise ABI (decrease of more than 0.15) if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a TBI \<0.8.
* Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 weeks, 6 months, 12 months, and at 24 months.

Exclusion Criteria:

* Patient is pregnant, breast-feeding or under 18 years of age.
* Patient unable to understand and sign informed consent forms
* Patient is simultaneously participating in another investigational drug or device study.
* Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
* Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
* Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol.
* Patient 2-3 patent crural vessel runoff with \<50% stenosis throughout its course.
* Activity limited by co-morbid condition other than claudication, for example: severe coronary artery disease; angina pectoris; chronic lung disease; neurological disorder such as hemiparesis; arthritis, or other musculoskeletal conditions including amputation and BMI \> 40
* Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anaemia, active substance abuse, or known history of dementia
Effectiveness of Using the Speedometer During Colonoscopy

PURPOSE OF PROTOCOL

Objective:

To evaluate if the speedometer based on the real-time image analysis can help endoscopists increase their withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, during colonoscopy.

Hypothesis:

The trial hypothesis is that use of the speedometer during colonoscopy will increase the average withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, by 1.6 minutes, possibly increasing the performance of the participating endoscopists. Our objective is to clarify the clinical benefits of this digital tool in colonoscopy.

Endpoint: Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).


Eligibility Criteria:
Inclusion Criteria:

* Both women and men aged 18 years or older undergoing colonoscopy for any indication at Beth Israel Deaconess Medical Center (BIDMC), Boston, USA.

Exclusion Criteria:

* Known colorectal cancer, hereditary colorectal polyposis, inflammatory bowel disease, or past history of colectomy.
A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy

Many persons with epilepsy have seizures which remain uncontrolled by anti-epilepsy medications and are unsuitable for or unwilling to undergo surgical treatments for their epilepsy, or have undergone such treatments and continue to have seizures. Dietary treatments for epilepsy have been shown to be effective in children, and are probably effective in adults, but compliance with the classic ketogenic diet (KD) and to some degree also the modified Atkins diet (MAD) seems difficult for many adults.

The LGI diet may be easier and in children appears to be of comparable efficacy to other dietary treatments (KD and MAD), but has been little studied in adults.

This is a randomised study of immediate versus deferred LGI diet in adults with seizures incompletely controlled by anti-epilepsy medications. 12 weeks of dietary treatment in those randomised to LGI will be followed by the opportunity for the control group to undertake 12 weeks of the LGI diet.


Eligibility Criteria:
Inclusion Criteria:

* adults (\>18 years)
* epilepsy refractory to at least two appropriate first line anti-epileptic drugs in adequate dose, unsuitable for or unwilling to undergo surgery for epilepsy.
* At least 1 seizure per week.
* BMI \>18

Exclusion Criteria:

* unable to give informed consent
* unable to comply with diet
* surgery for epilepsy or VNS within the last 12 months
* non-epileptic seizures
* pregnant or planning pregnancy
* significant renal impairment
* history of renal stones
G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients

This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed primary gynecologic cancer
* Good performance status
* Aged 18 years or older
* Signed an approved informed consents
* No immunosuppressive disease

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Plating of Humeral Shaft Fractures in Multiple Trauma Patients.

The purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. We will report our clinical and radiographic results, complication rate and final range of motion. A standardized outcome measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be evaluated by a standard protocol, accomplished with the assistance of a licensed physical therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal fractures via an antero-lateral approach with the use of small fragment fixation is a safe and efficacious way to treat multiple trauma patients with these injuries.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF)
* patients for whom the above fracture has healed
* patients willing and able to provide informed consent and able to participate in study procedures

Exclusion Criteria:

* patients with known pathological fractures
* patients with metabolic bone disease
* patients with humeral head or inter-articular surface fractures, or other upper extremity fractures
* patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.)
* patients with neurologic injury to upper extremities
Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express

Follow-up strategy for patients implanted with a pacemaker.

This study seeks to verify that a follow-up strategy for patients implanted with a mono- or double-chamber pacemaker, stimuli-dependent or not, for 2 years, by means of data transmissions of the devices by Carelink Express during the usual consultations with the treating cardiologist significantly reduces the number of unnecessary consultations in the implant centers (without any change in treatment or pacemaker programming) compared to the usual follow-up mode recommended for this type of device.

Eligibility Criteria:
Inclusion Criteria:

* Any patient implanted with a Medtronic brand AAI (R), VVI (R) and DDD (R) cardiac pacemaker, allowing transmission via Carelink Express (Medtronic)
* and accepting inclusion in the study.
* The patient should be followed by a city cardiologist participating in the study.

Exclusion Criteria:

* Age \<18 years
* Pregnant or likely to become pregnant during the study
* Patient with an unstable medical condition, NYHA Class IV Heart Failure
* Presence of psychiatric illness, depression, anxiety disorder
* Presence of diseases, other than heart disease, responsible for a reduction in life expectancy for the duration of the study.
* Patient unable to follow protocol (respond to questionnaires)
* Change of residence planned during the study
* Participation in an interventional and therapeutic clinical study; Patient participation in an observational study is permitted.
* Patient not signed consent form
* Patient under legal protection
Detection of Latent Tuberculosis in Hemodialysis Patients

This study aims to compare the performance of the tuberculin skin test, used for more than 50 years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have recently become commercially available (Interferon-gamma release assays) in a population of immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis

This prospective study includes all adults aged over 18 years of age who accept to be included in the study and provided written informed consent. All patients are under long term hemodialysis for chronic renal failure. They are subjected to a questionnaire including history of contacts with tuberculosis (TB), prior treatment for TB, history of prior tuberculin skin testing, history of BCG vaccination, country of origin, trips or prolonged stays in high incidence areas, smoking history, and medications. All patients will have a chest X-ray, and simultaneous testing with the tuberculin skin test according to the Mantoux technique, and with the T-SPOT. TB and QuantiFERON Gold in tube Interferon-gamma release assays. The study analysis agreement between tests, detection of prior TB and presumptive latent tuberculosis infection, based on these items.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged over 18
* Under hemodialysis for \> 3 months
* End stage renal failure

Exclusion Criteria:

* Refusal to participate
* Prior tuberculin skin test \> 15 mm or any adverse reaction to tuberculin skin test
Assessing and Reducing Risk of Violent Re-Injury Among Victims of Urban Violence

The purpose of the study is to develop a program to help people to lower their chances of being violently injured again.


Eligibility Criteria:
Inclusion Criteria:

* age between 18-65 years
* intentionally injured in community violence.
* admitted to a Level 1 trauma center
* able to provide voluntary informed consent

Exclusion Criteria:

* under the age of 18 or over the age of 55.
* not fluent in the English language
* patients with suspected mental retardation or active psychosis as determined by brief clinical screen.
* patients currently in legal detention status
Multicenter International Trial Ring AnnulopLasty

This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patient requiring a mitral valve repair due to mitral degenerative or functional disease (Note: Patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study);
* Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements;
* Patients are at least 18 years old.

Exclusion Criteria:

* Patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve;
* Patient is pregnant or nursing;
* Patient has active endocarditis;
* Patient is actively participating in another study of an investigational drug or device;
* Patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...);
* Patients who are intravenous drug abusers, alcohol abusers, prison inmates or unable to give informed consent;
* Patients with a major non-cardiac evolving disease;
* Patients with a life expectancy less than 1 year;
* Patients are known to be noncompliant or are unlikely to complete the study;
* Any case in which mitral annuloplasty rings are not indicated;
Pilot Study to Evaluate the Safety and Efficacy of Treatment With ORA102 Combined With Avastin (Bevacizumab) Versus Avastin Alone, in Patients With Neovascular Age Related Macular Degeneration (AMD)

This is s randomized, multi-center, double blind, 3 arm, phase I/II pilot study to evaluate the safety and efficacy of treatment with ORA102 combined with Avastin (Bevacizumab) versus Avastin alone, in patients with neo-vascular age related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have provided informed consent, including signing of the informed consent form
* Subject who are able and willing to comply with the study protocol
* Subject must have best corrected visual acuity ETDRS between 20/40 to 20/320 in the study eye
* Subjects whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy
* Women must be post-menopausal 1 year or surgically sterilized. If not, negative serum pregnancy test required within 14 days of randomization

Exclusion Criteria:

* Pregnant or lactating women
* Patients with severe myocardial disease or coronary occlusion
* Patients with severe personality disorder, suicidal risk or psychosis
* Patients with previous history of CVA
* Evidence for liver dysfunction - bilirubin level more than twice than upper limit of the normal value OR ALT/AST\>1.5x upper limit of normal value
* Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of the investigational drugs or puts the patients in high risk for treatment related complications
Effects of Mental Practice and Therapeutic Exercise in Mild Smokers

The goal of this clinical trial is to learn about the effects who would add mental practice based on action observation to a therapeutic exercise program in young mild smokers.

The main question it aims to answer is whether the observation of actions prior to the implementation of a therapeutic exercise program improves the response to it on respiratory, strength and muscle function variables.

Participants will be assigned to one of 2 study groups:

G1) Therapeutic exercise plus action observation training (n=20) G2) Therapeutic exercise plus sham action observation training (n=20)


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Had a pack per year index of \<5 (mild smoking index).

Exclusion Criteria:

Those who presented:

* a respiratory pathology,
* cardiac, systematic, or metabolic disease,
* history of recent surgery,
* vertebral fracture,
* or osteoarticular disorders of the spine area.