cyrilzakka/clinical-trials huggingface dataset:
A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).


Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy
* Has previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status
* The ability to swallow and retain oral medication

Exclusion Criteria:

* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
* Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy
* History of severe bleeding disorders
* Not adequately recovered from major surgery or has ongoing surgical complications
Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

Several recent studies have examined the feasibility and benefits of nonoperative treatment of perforated appendicitis in children. One such study showed a trend toward longer operative times for patients randomized to immediate appendectomy, but no overall advantage. In another larger study, the costs of delayed appendectomy for perforated appendicitis were higher - in part related to readmissions in the interval (6-8 weeks). Nevertheless, these and other studies have demonstrated the safety of delaying appendectomy for perforated appendicitis.

Emergency appendectomy is a well-established approach, and postoperative recovery in children is fast. Nevertheless, from the onset of symptoms through the hospital stay and the postoperative recovery, appendicitis causes a disruption of a family's normal routine (absence from school and work) of up to 1-2 weeks. Because this is an unplanned operation, patients have to wait until an operating room becomes available, or elective operations have to be placed on hold to accommodate the emergency operation. Each year, more than 250 children undergo an appendectomy at HCH. This represents 250 episodes of emergency surgery, or about one emergency add-on operation per working day. If an initial trial of antibiotics is safe for the treatment of appendicitis, converting an emergency operation into an elective, scheduled outpatient procedure may reduce stress and disruption of routine for patients and their families - and may allow better operating room planning for health care professionals and hospitals.

The investigators hypothesize that initial antibiotic treatment of acute (non-perforated) appendicitis, followed by scheduled outpatient appendectomy, reduces the overall cost of treating the disease and results in greater patient and family satisfaction.

This pilot study aims to establish the safety and feasibility of treating acute appendicitis with intravenous antibiotics, followed by outpatient oral antibiotics. Patients and their families will be offered the possibility of initial nonoperative treatment and subsequent outpatient elective appendectomy in a nonrandomized, single arm study.


Eligibility Criteria:
Inclusion Criteria:

* Maximum 48-hour-history of abdominal pain
* Diagnosis of acute appendicitis based on clinical, laboratory and/or radiologic criteria

Exclusion Criteria:

* Duration of symptoms \> 48 hours
* Presence of an appendiceal abscess on imaging
* Clinical or laboratory suspicion of advanced appendicitis, peritonitis or perforation
* Significant comorbidities
* Inability or unwillingness to complete a 1-week course of oral antibiotics
* Allergy to penicillin
Safety Study of HBV-002 West Nile Vaccine in Healthy Adults

The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in healthy adults.

West Nile virus is an emerging infectious disease in the U.S. and worldwide and has been identified by the CDC as a significant public health risk. Since the introduction of West Nile virus into the U.S. in 1999, annual outbreaks have caused severe and fatal encephalitis in humans and equines and death in a variety of species of feral birds throughout the U.S. and parts of Canada. In addition, more recent findings show evidence of West Nile virus human and equine infection in several countries of tropical America. The virus has now been found in bird populations in all 48 states of the continental U.S, and human cases of West Nile disease have been documented in 45 states and the District of Columbia. To date, there is no approved commercial vaccine available for prevention of West Nile virus disease in humans.

Eligibility Criteria:
Inclusion Criteria:

* Satisfactory medical assessment with no clinically significant and relevant abnormalities (medical history, physical examination, vital signs, ECG, clinical laboratory evaluation \[hematology, biochemistry, urinalysis\])
* Body weight must not be more than 10% below of 20% above the ideal weight for height and frame size according to the 1999 Metropolitan Life table

Exclusion Criteria:

* Current active infection process including URI or influenza
* Positive serum test for HIV, Hepatitis B surface antigens and/or Hepatitis C antibodies
* History of infection with, or serologic evidence in screening test, of prior flavivirus infection (to include viruses: West Nile, 4 dengue serotypes, yellow fever (YF), and Japanese encephalitis (JE)
* Subject has resided in flavivirus (West Nile, 4 dengue serotypes, YF, and JE) endemic areas or has a history of receipt of Yellow Fever or Japanese encephalitis virus vaccines
* History of alcohol or other substance abuse within 1 year of screening
* Use of corticosteroids or immunosuppressive drugs within 30 days of screening (Use of topical or nasal corticosteroids are not excluded.)
* Any confirmed or suspected immunosuppressive or immunodeficient condition
* Administration of immunoglobulins within three months of the first vaccination or planned during the study period
* Receipt of any vaccines or investigational or non-registered product other than HBV-002 within 30 days prior to screening or planned receipt throughout the study.
* Receipt of another study vaccines within 30 days prior to screening
* Receipt of blood products within 6 months of screening
Automated Inferior Vena Cava Collapsibility Index Fluid Responsiveness in Ventilated Patients After Cardiac Surgery.

Echocardiographic measurement of inferior vena cava (IVC) collapsibility index (CI) with automated software analyses has been introduced. This study aims to assess the accuracy of IVC-CI (caval index) measurements as well as the ability to track fluid responsiveness (FRes) over time comparing the automated echocardiographic method with the pulse pressure variation (PPV) technique and the manual echocardiographic method in cardiac surgery patients.

It is expected to have insights about the concordance rate. The automated echocardiographic method of measuring CI method may or may not meet the criteria for interchangeability with the thermodilution technique or the manual echocardiographic method.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age more than18 years old. 2. Cardiac surgical patients including (coronary artery bypass graft surgery, valvular surgeries, and aortic dissection surgeries) 3. Need for decision to administer IV fluids (hypotension that require assessment and possible fluid boluses defined as a systolic blood pressure less than 90mmHg. Normotensive patients who require fluid therapy with any other manifestation of low perfusion including tachycardia, low urine output, increased core-peripheral temperature gradient, serial increase in serum lactate, and serial increase in base deficit, and normotensive). The endpoint of fluid resuscitation is return normal blood pressure

Exclusion Criteria:

-1. Contraindication for fluid administration including acute pulmonary edema. 2. Moderate or more tricuspid valve lesion or pulmonary hypertension (more 50 mmHg) where high central venous pressure is expected 3. Patients on hemodialysis. 4. Patient on intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) 5. Irregular cardiac rhythm: patients with atrial fibrillation or frequent ectopics are excluded.

6. Patients with chest open 7. Poor echocardiography window (The images will be stored and analyzed by senior physician within the ICU certified in echocardiography)
CKD-828(80/2.5mg) Pharmacokinetic Study_2nd

The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.


Eligibility Criteria:
Inclusion Criteria:

* A healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.
* Have not any congenital or chronic diseases and medical symptom.
* Appropriate for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening).
* Able to participate in the entire trial.
* Signed the informed consent form prior to the study participation.

Exclusion Criteria:

* Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administraion.
* Take oriental medicine inside St John's Wort or metabolism of CYP3A4 enzyme or inhibite the CYP enzyme or increase the making drugs(itraconazole, ketoconazole, erythromycine, clarithromycine, telithromycin, HIV protease inhibitor)
* Disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
* Relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
* Hypersensitivity Telmisartan or Amlodipine.
* SBP\<90mmHg, 150mmHg\<SBP or DBP\<50mmHg, 100mmHg\<DBP.
* Abnormal laboratory result(s): AST or ALT \> 1.25 times of upper limit / Total bilirubin \> 1.5 times of upper limit.
* Creatinine Clearance\<80mL/min
* Clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, nervous system or hyperpotassemia (Past history or present)
* History of drug abuse(sleeping tablet, nucleus action painkiller, an opiate or psychotrope etc the central nervous system drug)or showed a positive for the urine screening exam.
* any abnormal diet which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. drinking grapefruit juice(more than 1L per a day) during 7 weeks prior to the first IP administration.)
* A heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
* Previously donate whole blood within 60 days or component blood within 30 days prior to the first IP administraion.
* Medication within 7 days in the first IP administraion professional medical, medicine, OTC taking
* Participated in the other clinical trials within 60days prior to the first IP administraion.
* An impossible one who participates in clinical trial by investigator's decision
Rescue Carotid Stenting in Tandem Occlusions: 4-year Experience From a Comprehensive Stroke Centre

The rescue carotid stenting has recently been an additional treatment followed by mechanical thrombectomy in tandem occlusions of the anterior circulation. Nevertheless, there were few data to date that support this beneficial treatment in Asia. The investigators hypothesized that this treatment related to improvement of clinical outcomes after procedure.

The anterior circulation made commonly up 70-80% of all ischemic strokes. The mechanical thrombectomy is the gold treatment standard in acute ischemic stroke due to large vessel occlusion of anterior circulation. Tandem occlusions are one of the acute lesions relating to the high poor clinical outcome rate. Besides, tandem characteristic is a challenge to perform endovascular therapy and save procedural time in the restoration blood flow to the cerebral artery territory infarction. Many studies demonstrated the roles of rescue carotid stenting with either proximal-to-distal or distal-to-proximal approach in the successful recanalization of tandem occlusions. However, few studies analyzed in detail this beneficial treatment in Asia. Therefore, the investigators conducted this study to assess whether rescue carotid stenting in the tandem occlusions to improve clinical outcomes at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Onset to treatment time \< 24 hours
* NIHSS \> 5
* DWI-ASPECTS ≥ 5

Exclusion Criteria:

* Premorbid mRS \> 2
* Loss to follow-up after discharge
Non-interventional Study With Azacitidin (Vidaza®)

The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are not eligible for haematopoietic stem cell transplantation, who are at least 18 years old (no age limit to top) and who have one of the following diseases:

  * myelodysplastic syndrome (MDS) with intermediate risk 2 or high risk according to the International Prognostic Scoring System (IPSS)
  * chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder
  * acute myeloid leukemia (AML) with 20-30% blasts and multilineage dysplasia according to classification of the World Health Organisation (WHO).

Exclusion Criteria:

* Contraindication according to the summary of product characteristics of Vidaza®
* Signed patient informed consent form is not available
* Patients with advanced malignant hepatic tumors
* Pregnant or nursing women, men and women (of childbearing age) who are unwilling to apply a reliable method of contraception during and up to three months after treatment with Azacitidine
* Necessary or planned treatment with other systemic cytostatics
* Known medical history of severe decompensatoric cardiac insufficiency
* Medical history of clinically unstable cardiac or pulmonary disease
* Known or suspected hypersensitivity to azacitidine or mannitol
Effect of Blood Flow Restriction on Football-Related Performance Parameters

The blood flow restriction method can have similar or superior effects to high-intensity exercises even in a short duration, which can positively affect some performance parameters, can be applied with low-intensity load and cause hypertrophy in the muscle by providing high metabolic stress, facilitating muscle growth without significantly changing the total training dose. The aim of this study is to investigate whether adding the blood flow restriction method to the classical training program can be more effective than the classical training applied alone in the development of football-related performance parameters.


Eligibility Criteria:
Inclusion Criteria:

* Being a male between the ages of 18-30 years
* Volunteer to participate in the study
* Playing football in one of the clubs in Istanbul for at least 1 year
* Being in the pre-season of the club
* Absence of any ongoing musculoskeletal problems that limit exercising

Exclusion Criteria:

* Having at least one of the contraindications preventing the application of blood flow restriction (Smoking, previous venous thromboembolism, risk of peripheral vascular disease (ankle-brachial index \<0.9), coronary heart disease, hypertension, hemophilia, etc.).
* History of sports injury in the last 6 months
* Orthopedic lower extremity surgery in the last 1 year
* Body mass index ≥ 30 kg/m2
Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma

The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible for autologous transplantation.

This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of R-GEMOX in refractory/relapsed patients aged from 18 to 75 years with CD20-positive large B-cell lymphoma non eligible for autologous transplantation.

It is anticipated that 50 subjects will be enrolled over 4 years (from April 2003/January 2007), but inclusion could stop earlier according to the analysis performed every 5 patients (based on triangular test).

The duration of the treatment period is approximately 16 weeks and patients are followed until death.

The total duration of the study is expected to be 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with histologically or cytologically proven, CD 20+, diffuse large B-cell lymphoma,
* Relapse after first or second CR, PR or less than PR to first-line treatment for the rituximab-naïve patients, OR relapse after first or second CR with a minimum delay of 12 months between the last rituximab infusion and the inclusion for the rituximab-experienced patients
* Aged 18 - 75 years
* Not eligible for autologous transplantation
* Previously treated with chemotherapy containing anthracycline, with or without rituximab
* ECOG performance status 0 to 2
* With a minimum life expectancy of 3 months
* Having signed informed consent form prior to enrollment

Exclusion Criteria:

* Burkitt's, mantle cell, T-cell lymphomas
* CD 20-negative lymphoma
* HIV or HBV related disease
* Central nervous system or meningeal involvement by the lymphoma
* Not previously treated with anthracycline-containing regimens
* Contraindication to any drug contained in the R-GEMOX chemotherapy regimen
* Any serious active disease or co-morbid medical condition (according to the investigator's decision),
* Poor renal function (creatinine level \> 150micromol/l), poor hepatic function (total bilirubin level \> 30mmol/l, transaminases \> 2.5 maximum normal level) unless these abnormalities are related to the lymphoma
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l, unless related to bone marrow infiltration
* Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
* Any radiotherapy during the four weeks before inclusion
* Pregnant or lactating woman
* Adult patient unable to give informed consent because of intellectual impairment.
Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment

This study is to assess the effect of Renuva® on fat pad regeneration in patients with Fat pad Impingement

The fat pad of the knee works to stabilize the patella and releases cytokines, growth factors, and stem cells. These cytokines, growth factors, and stem cells exhibit anti-inflammatory, anabolic effects that can be recruited to heal the articular tissues of the knee and ameliorate their catabolic effects during osteoarthritis (OA).

The majority of the current treatments for fat pad impingement (FPI) and its sequelae are primarily symptom-modifying, and structure-modifying therapies both at the joint and peri-articular structures levels cannot be overemphasized.

Renuva® (MTF Biologics) is a Food and Drug Administration approved, off-the-shelf, injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue. Once injected, native cell populations infiltrate the AAM, and over time, the AAM remodels into native tissue and stimulates both adipogenesis and angiogenesis within the tissue.

Our specific aim is to assess the effect of Renuva® on fat pad regeneration in patients with FPI. The investigators hypothesize that injection of Renuva® into a diseased fat pad of the knee increase the volume of the fat pad and reduce any hemorrhage, edema or fibrosis present, when pre-to post-treatment images are compared.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years of age
* Fat pad impingement
* Knee MRI taken before study enrollment
* Working knowledge of English language (to be able to complete all outcome scores)
* Ability to attend all follow-up appointments.
* Able to undergo MRI

Exclusion Criteria:

* Medical condition that may impact outcomes of procedure including:

  * Systemic inflammatory disorders that impact the joints like rheumatoid arthritis, lupus, etc
  * Undergoing current cancer treatment (other than non-melanoma skin malignancies)
* Gout, Pseudogout (including radiographic evidence of chondrocalcinosis)
* History of infection or current infection at the affected joint
* Smoking (Former smokers\< 1 year from quit date)
* Significant allergies manifested by a history of anaphylaxis or severe allergen sensitivity
Diagnosis of PD and PD Progression Using DWI

This project will evaluate the utility of diffusion tensor imaging (DTI) as an adjunctive method to improve early diagnosis of Parkinson's disease (PD). Two populations will be evaluated in this study: 1) Individuals with uncertain PD diagnosis who receive a DaTscan, and 2) individuals with well characterized PD and healthy controls, drawn from the fully enrolled Parkinson's Progression Markers Initiative (PPMI) PD and control cohorts.

Specific Aim 1a: Compare the outcome of a DTI based prediction with a contemporaneous clinical DAT scan in 100 subjects with suspected parkinsonism, and determine rate of concordance between the two diagnostic techniques.

Specific Aim 1b: Compare predictive accuracy of a baseline DTI with a "gold standard" expert diagnosis after 36 months of follow up in 100 subjects receiving DaTscan for suspected parkinsonism.

Specific Aim 2a: Use TBM to evaluate volume and cross-sectional caliber (based on point-wise fiber track direction) of the fimbria, pallidonigral tracts, and subthalamic-nigral tracts in PD and healthy controls. Ascertain if changes in white matter volume and caliber can be used to predict presence of PD from the PPMI study. Secondarily, using a model free approach, determine what white matter features based on TBM predict presence of disease.

Specific Aim 2b: Use TBM to determine if an increased rate of change in volume and cross-sectional caliber of the fimbria, and hypertrophic pallidonigral, and subthalamic-nigral tracts identified in aim 2a, are associated with a more rapid rate of disease progression in PD. Secondarily, using a model free approach, determine what white matter features based on TBM predict a faster rate of disease progression over the 5 year course of the PPMI study.

Specific Aim 3a: Compare DTI FA in TD-PD and PIGD-PD in the thalamus and lobule IX of the cerebellum , studying subjects from the PPMI study. Predict signal in these regions will predict phenotypic expression of disease. Using TBM and bootstrapping, determine the relationship between phenotypic expression of disease and white matter input/output pathways from the thalamus, and from lobule IX of the cerebellum.

Eligibility Criteria:
Inclusion Criteria:

* Patients 19 and older
* Referred for clinical DaTscan for possible PD
* Controls from the PPMI dataset.

Exclusion Criteria:

* Pregnant women
* Participants that cannot participate in MRI (metallic artifact or other contraindication(s) to MRI at 3T)