cyrilzakka/clinical-trials huggingface dataset:
MK-3795 (PT2385) for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma (MK-3795-003)

The primary objective of this study is to assess the overall response rate (ORR) of von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC) tumors in VHL participants treated with MK-3795.

This open-label Phase 2 study will evaluate the efficacy, safety, PK, and PD of MK-3795 in participants with VHL disease who have at least 1 measurable VHL disease-associated ccRCC tumor (as defined by RECIST 1.1). MK-3795 will be administered orally and treatment will be continuous. Changes in VHL disease-associated non-ccRCC tumors will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Has at least 1 measurable ccRCC tumor and no solid ccRCC tumor greater than 3.0 cm, based on radiologic diagnosis (histologic diagnosis not required); may have VHL disease-associated lesions in other organ systems
* Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration

Exclusion Criteria:

* Has had prior radiotherapy or systemic anti cancer therapy for ccRCC (includes anti-vascular endothelial growth factor (VEGF) therapy or any systemic investigational anti cancer agent)
* Has a prior or concomitant non-VHL disease-associated invasive malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the participant has remained disease free for more than 2 years
* Has any history of metastatic disease
* Has had radiotherapy to any non-ccRCC site within 4 weeks prior to entering the study or has not recovered from adverse events (AE)
* Has had any surgical procedure for VHL disease or any major surgical procedure completed within 4 weeks prior to entering the study or has any surgical lesions from recent major surgical procedures that are not well healed
Effect of Segmental Control Program on Hamstring Peak Torque in Patients With Non-specific Low Back Pain

The purpose of this study is to investigate the effect of segmental control exercises program on hamstring peak torque, pain, function, and ROM in patients with non-specific low back pain.

Low back pain (LBP) is a significant health problem internationally characterized by various biophysical, psychological, and social dimensions affecting functioning, societal participation, and personal financial prosperity.The reported prevalence of LBP was high, especially for chronic non-specific low back pain, approximately 15.4%. of which chronic low back pain was about 2.5 times more prevalent in the working population compared to the non-working group. Recently, there has been a focus on lumbar stabilization exercises that prove to be effective and may be superior to general exercises for LBP management. The approach is aimed at improving the neuromuscular control, strength, and endurance of the active subsystem stabilizing the spine. Several groups of muscles are particularly targeted namely, the transverses abdominis and the multifidus muscles that are central to maintain spinal and trunk stability. But also other core muscles are involved. so this study will be conducted to investigate the effect of segmental stabilization exercise on low back pain. forty-five patients will be allocated to three groups. first experimental will receive segmental stabilization phase 1 and phase 2, second experimental will receive segmental stabilization phase 1 and 3, the third one is the control group and receives traditional treatment

Eligibility Criteria:
Inclusion Criteria:

1. The patients had NS LBP Patients with age from 20 to 40 years for both genders.
2. The lumbar region of back pain lasts for 4 weeks \& more has not been diagnose as a specific disease or spinal abnormality.
3. Mild to moderate disability according to the Oswestry Disability Index (ODI) (up to 40%).
4. Shortening of hamstring.
5. The study populations must be willing to participate in the study.

Exclusion Criteria:

1. Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor, cardiovascular disease.
2. Psychiatric/mental deficit
3. Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS

This is a research study to understand and determine the effectiveness of electronic cigarettes versus nicotine replacement therapy in adults who smoke and also live with HIV/AIDS in effort to reduce cigarette smoking.

People living with HIV/AIDS (PLWHA) are known to have exceptionally higher rate of cigarette smoking and very low quit rates compared to the general population. Although a primary rationale for conducting this study is reducing health disparities among PLWHA, there is a potential benefit of the proposed work from a prevention perspective given that combustible cigarette smoking is an independent risk factor for non-adherence to ART and may decrease the effectiveness of HAART. Smoking-related illnesses are leading causes of non-HIV/AIDS-related deaths among People Living with HIV/AIDS (PLWHA). Electronic cigarettes (E-cigarettes) could help people reduce the harm of combustible cigarette (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely by addressing both nicotine and behavioral dependence. Unlike CC, EC are not associated with coronary heart disease or myocardial infarction. The purpose is to identify barriers and facilitators, as well as assess preliminary effectiveness of e-cigarettes as a harm reduction strategy among PLWHA.

Eligibility Criteria:
Inclusion Criteria:

* Current Combustible Cigarette (CC) smokers (more than 5 packs in a lifetime; smokes 4 or more days/week),
* Smokes at least 10 cigarettes per day on days they smoke CC.
* Motivated to quit smoking (at least a 5 on a 10-point Likert scale).
* Must be able to provide consent
* Agree to be randomized and followed-up with,
* Reside in New York City
* Be willing to use an e-cigarette or NRT for 12 weeks.

Exclusion Criteria:

* Are pregnant (as determined by urine test) or breastfeeding (self-reported),
* State diagnosis of any medical condition (angina/heart disease) precluding use of nicotine patch or gum, or by self-report in screening questionnaire
* Reporting using NRTs or e-cigarettes or within the last 30 days
* Have untreated/are undergoing current treatment for psychiatric illness or cognitive impairment at time of initial screening as determined by the subjects' primary care doctor or a licensed study team member in screening
* Report a history of severe or untreated cardiopulmonary disease such as asthma or emphysema.
Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies

The purpose of this study is to assess the feasibility of a 60 minute rapid infusion rituximab protocol in the institution's outpatient infusion center.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-89
* Diagnosis of indolent or intermediate grade B-cell malignancy
* Patients receiving rituximab-based therapy at a dose of 375mg/m2, regardless of weight
* First dose given within 3 months of the second dose
* Infusion scheduled for outpatient administration at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Exclusion Criteria:

* Diagnosis of aggressive lymphoma
* Absolute lymphocyte count \> 10 x 103 cells/µL
* New York Heart Association (NYHA) classification Grade II or greater congestive heart failure
* Enrolled on another clinical trial
* Allergy to murine-containing medications
* Grade III or IV hypersensitivity reaction during the initial infusion of rituximab
* Prisoners
* Pregnant women
* Mentally or physically unable to give consent
A Trail of a Novel Tracheal Radioactive Stent for the Malignant Airway Obstruction

The aim of this study was to evaluate the safety and effectiveness of an radioactive airway stent loaded with 125I seeds compared to a conventional airway stent in patients with malignant airway obstruction caused by both primary and metastatic malignant tumors.

Malignant tumors of the lung, esophagus, thyroid, or other mediastinal structures often involve the trachea by direct tumor growth compression and (or) invasion. In addition, extrathoracic cancers metastasize to these lymph nodes as well. However, surgical resection and airway reconstruction are the gold-standard treatment for MAO, many patients with airway involvement are poor surgical candidates based on physiologic or oncologic criteria.There are three main types of malignant airway obstruction: endobronchial obstruction, extrinsic compression, and a mixed pattern. For endobronchial obstruction, ablative techniques that destroy tissue are indicated, including lasers, electrocautery, argon plasma coagulation (APC), photodynamic therapy, microdebriders, and cryotherapy, but primary tracheal cancers are less common than other types of lung cancer. If the obstruction is exclusively or mainly due to compression from outside the airway wall, the only option consists of placement of a stent or endoprosthesis. However, follow-up data has demonstrated that postoperative restenosis of stenting occurs in 5-45% of cases as a result of neoplastic infiltration through the mesh into the lumen or tumor overgrowth above and below the mesh stents. Encouraged by the success of 125I esophageal and biliary stent in esophageal carcinoma , a tracheal stent loaded with 125I radioactive seeds was developed in investigators'institute. After successful in vitro and in vivo evaluations of the delivery system, investigator will prospectively compare responses to treatment with this irradiation tracheal stent versus the conventional self-expandable stent in patients with MAO.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 18 and 80 years
2. MAO caused by any adenocarcinoma with histologically or cytologically confirmation by biopsy or previous surgical procedures
3. symptoms such as dyspnea related to biliary obstruction
4. unresectability or refusal to be surgically treated
5. willing and able to comply with the study procedures and provide written informed consent to participate

Exclusion Criteria:

1. patients with suspected benign airway obstruction
2. airway obstruction that could not be dilated enough to pass the delivery system
3. perforation of any ducts within the tracheal tree
4. presence of metallic tracheal stent or airway surgery
5. acute or chronic inflammation in the airway
6. uncooperative or could not provide authorization and signature.
The Genetic Basis of Inherited Neurologic Deficits in People With Schizophrenia

This is a study of the genetic basis of brain dysfunction in people with schizophrenia.

Schizophrenia is a disabling disorder that is associated with specific inheritable neurobiologic deficits. These deficits can cause problems with memory, visual attention, information processing, and other aspects of daily living. Understanding the genetic components of these deficits in people with schizophrenia and their unaffected family members may help uncover the neurobiological basis, risk factors, and heritability of the disease. In addition, the information may serve to create more effective treatments and possibly a cure for the disease. This study will serve to provide information about the genetic basis of known inherited neurobiological deficits in people with schizophrenia. In turn, this may guide further studies on the genetics of schizophrenia.

Participants will attend 2 study visits, each of which will last approximately 4 hours. The first will include blood tests and diagnostic interviews of participating families to evaluate the presence of schizophrenic symptoms. The second study visit will entail four neurocognitive and neurophysiological tests. Participants will first have a pre-pulse inhibition test, which uses electrodes to measure eye blinking. Electrodes will also be placed on participants' head, ears, and around their eyes to measure brain waves. Next, participants will undergo an oculomotor test, during which they will wear glasses fitted with sensors that record eye movement. Participants will then be asked to repeat a list of words, letters, and numbers read by a researcher. Last, participants will undergo a computerized performance test requiring them to watch the computer screen and click a mouse whenever they see a number between 0 and 9. Each study visit will take approximately 4 hours.

Eligibility Criteria:
Inclusion Criteria for Participating Families:

* Families with at least one member who has schizophrenia

Exclusion Criteria:

* N/A
Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia

This study aims to evaluate the effectiveness of single buccal local infiltration when compared to buccal local infiltration with intrapapillary infiltration and inferior alveolar nerve block anesthesia in primary mandibular molar extractions.

Effective pain control is essential in providing children with successful dental treatment. Without it, negative experiences may result in anxiety and fear-related behaviors towards subsequent dental treatment. Local anesthesia is the cornerstone of pain control in dentistry. Choosing the right local anesthetic technique is of special significance .

The inferior alveolar nerve block (IANB) is a common practice for anesthetizing mandibular molars and/or premolars on one side of the jaw. It is achieved by depositing local anesthetic solution at the entrance to the mandibular canal, which inhibits the transmission of action potentials along the inferior alveolar nerve.

Administering an IANB can be technique sensitive and failure rates are reported to be up to 20%, due to anatomical variations in the position of the mandibular foramen and accessory innervations. This effect may be compounded for those who are not used to anesthetizing children .

However, Supraperiosteal infiltration has the advantages of easier administration when compared to block anesthesia, shorter anesthetic duration, and generally does not anesthetize the lips .

An ideal local anesthetic should provide maximum efficacy, through a minimal number of injections, using techniques that provide the least discomfort, causing negligible adverse effects .

Eligibility Criteria:
Inclusion Criteria:

* Badly decayed primary mandibular molars indicated for extraction with not less than half of the root length present.
* Children ranging in age from 5-8 years

Exclusion Criteria:

.Allergies to local anesthetics.

* History of significant medical conditions.
* Children under any medications.
* Presence of abscess, sinus opening.
* Uncooperative children without access to or with difficulty accessing dental care.
Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area

The investigators' previous studies in 2014 and 2015 have demonstrated that among community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia indices can be improved and bone mineral density (BMD) maintained with different exercise programs. In 2016, the investigators aim to determine the effects of 2 exercise interventions on posture corrections and further improvement of sarcopenic indices

The current study enrolled subjects who already participated in the 2015 study (n=109) at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB). Subjects will be maintained in their original integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50) when possible. If target sample size is not reached, clinic patients are screened for high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX for enrollments. New participants are randomized into the ICG and MTG groups. Other than assessments provided in 2015, digital photography on posture and low back pain assessments are done in 2016. All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with more focus on central muscle groups. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistance training on major muscle groups. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power, Chinese version of Oswestry Disability Index v 2.1 score (for low back pain), and spine curve angle (by photography) at baseline and after 12-weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

1. older than 50 years of age
2. high risk as defined from one of the following criteria: score≥1 on one minute osteoporosis risk questionnaire; 10 year predicted fracture risk≥20% for major osteoporotic fracture or ≥3% for hip fracture from FRAX; fall≥2 times in pass 1 year
3. having a bone mineral density test within one year period
4. having the capability to understand the study and complete the study interventions
5. willing to participate for the intervention and study follow ups

Exclusion Criteria:

1. People younger than 50 years of age
2. Could not communicate because of hearing, visual, or cognitive problems
3. Unable to stand and walk unaided (walking aids are acceptable)
Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease.

This observational study explores the impact of cognitive impairment and frailty in older adults with advanced chronic kidney disease \].

The main question\[s\] it aims to answer are:

* What determines the time to initiate dialysis? Cognitive impairment or frailty?
* What does predict the time to death? Presence of frailty or cognitive impairment?
* What does correlate strongly with time-low health-related quality of life? frailty or cognitive impairment?


Eligibility Criteria:
Inclusion Criteria:

* Patients age 65 years or older.
* CKD stage 4 and 5 who were identified by two consecutive measurements of estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 separated by more than 3 months.

Exclusion Criteria:

* Patients younger than 65 years old.
* Chronic kidney disease stages 1,2, and 3.
* Dialysis dependence
* History of kidney transplantation.
* Initial visit with the health care provider.
* Recent acute kidney injury.
* Patients who had been hospitalized for more than 2 months before the visit (because long hospitalization might affect the degree of frailty)
* Patients with myocardial infarction and cerebrovascular accident 3 months before the assessment
* Patients who are blind or with limb amputation.
* Patients who refuse to participate.
Timing of Estrogen Support During the Luteal Phase of in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycle

To test the hypothesis that adding estradiol (E2) to progesterone supplementation later in the luteal phase of in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles, rather than earlier in the luteal phase, improves clinical pregnancy rates (PRs).

Several studies reported that elevated E2 may have a detrimental effect on endometrial receptivity and embryo. This conflict was the starting point of our study. The investigators thought that this luteal decrease in E2 level could be prevented by adding estradiol just before the receptivity window is open, instead of adding earlier in the luteal phase which could result in defective embryo implantation.

Eligibility Criteria:
Inclusion Criteria:

* All patients on long GnRH agonist protocol with controlled ovarian hyperstimulation who were seen in our IVF clinic between February and November 2008, and who have E2 levels on the day of hCG administration \>2500 pg/dl

Exclusion Criteria:

* Presence of azoospermia requiring testicular sperm extraction procedure
* endometriosis greater than stage II
* unilateral oophorectomy, polycystic ovarian syndrome (PCOS)
* secondary infertility
* age greater than 40 yrs and a basal follicle stimulating hormone (FSH) level higher than 12 mIU/ml were exclusion criteria
A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
* Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease (SD), partial response (PR), or complete response (CR).
* At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to randomization
* Child-Pugh class A within 7 days prior to randomization
* Adequate hematologic and end-organ function

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
* History of leptomeningeal disease
* History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Dynamic Heart Failure Prediction With Real-time Functional Status Data in the Ambulatory Setting

Heart failure is the number one cause of hospital readmission in those over 65 years of age and the current standard-of-care of weight self-monitoring is inadequate to predict exacerbation. This project aims to improve the monitoring of heart failure disease progression through the use of real-time, up-to-date data obtained both from a smart phone-based tool and from the electronic health record. The goal is to develop a low-risk, clinically validated method to estimate dynamic heart failure risk to enable the provision of earlier, more effective outpatient interventions that decrease hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for decompensated heart failure
* Age \>=18 years
* Owns a smart phone
* Willing to measure self assess 6 minute walk test weekly

Exclusion Criteria:

* None