cyrilzakka/clinical-trials huggingface dataset:
Rapamycin With Grapefruit Juice for Advanced Malignancies

The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Patients with hematologic malignancies (lymphoma, multiple myeloma and chronic lymphocytic leukemia (CLL) only) are eligible to participate in the phase IB portion of the trial only.
* At least 4 weeks since prior chemotherapy or radiation therapy
* Aged 18 years or older
* ECOG performance status 0-2
* Life expectancy of greater than 3 months.
* Normal organ and marrow function:

  * No transfusions of packed red blood cells within 1 week of starting treatment
  * Leukocytes greater or equal to 3,000/μL

    \*\* White blood cell (WBC) greater or equal to 1,500/μL for patients with hematologic malignancies
  * Absolute neutrophil count (ANC) greater or equal to 1,500/μL

    \*\* ANC greater or equal to 1,000/μL for patients with hematologic malignancies
  * Platelets (PLT) greater or equal to 100,000/μL

    \*\* PLT greater or equal to 50,000/μL for patients with hematologic malignancies
  * Total bilirubin within normal institutional limits
  * AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times institutional upper limit of normal
  * Serum triglycerides less than or equal to 500 mg/dl
  * Creatinine within normal institutional limits OR creatinine clearance greater or equal to 60 mL/min for patients with creatinine levels above institutional normal
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* May not be receiving any other investigational agents.
* Uncontrolled brain metastases or malignancy. Cannot be receiving enzyme-inducing anticonvulsants.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin
* Gastrointestinal malabsorption syndromes, partial small bowel obstruction, or any illness that would interfere with the ability to absorb oral medications.
* Uncontrolled intercurrent illness
* Severe immunodeficient states (as judged by the treating physician)
* Pregnant women are excluded from this study; breastfeeding should be discontinued.
* HIV-positive patients receiving combination antiretroviral therapy are excluded.
* Concurrent use of ketoconazole, cyclosporine, tacrolimus, diltiazem, and rifampin with rapamycin is not permissible. The concurrent use of calcium channel blockers, terfenadine, astemizole, cisapride, propafenone, cyclosporine, midazolam, triazolam, quinidine, or theophylline with grapefruit juice is not permissible.
Efficacy and Safety Study of Meloxicam Versus Mefenamic Acid in Patients With Dysmenorrhea

To access the efficacy and safety of Meloxicam 7.5 mg and 15 mg once daily compared with Mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea


Eligibility Criteria:
Inclusion Criteria:

* Female patients between 18 to 40 years
* Patients experiencing primary (functional) dysmenorrhea during the last 3 consecutive menstrual periods. Diagnosis will be based on symptoms and clinical signs: abdominopelvic pain, may radiate to the back and along the thighs; systemic symptoms including nausea, vomit, diarrhoea, headache, fatigue, nervousness, dizziness; the symptomatology should be usually some hours to one day before commencement of visible vaginal bleeding
* Evaluation of lumbar and/or abdominopelvic pain due to dysmenorrhea \> 35 mm through a 100 mm visual analogue scale (VAS)
* Outpatients
* Patients granting their written informed consent
* Therapy with a NSAID (nonsteroidal antiinflammatory drug) is required or recommended

Exclusion Criteria:

* Known or suspected hypersensitivity to trial drugs or their excipients, analgesics, antipyretics or NASIDs
* Analgesic concomitant treatment (between each cycle paracetamol administration will be allowed)
* To initiate hormonal contraception or intrauterine devices after inclusion to this trial or during the last 3 months
* Abdominal surgery or pelvic procedure scheduled during the study
* Patients with organic dysmenorrhea (endometriosis, salpingitis, adnexitis, uterine retroversion, tubal cysts, ovarian cysts, pathological vaginal secretion, painful pelvic exploration, etc.)
* Patients with neoplastic disorders
* History of recent abdominal or pelvic trauma requiring surgery
* Peptic ulcer within the past 6 months
* Pregnancy or breast feeding
* Asthma, nasal polyps, angioneurotic edema or rash following aspirin or NSAIDs administration
* Concomitant treatment with anti-coagulants, including heparin and aspirin, lithium or methotrexate
* Concomitant administration of other NSAIDs (including aspirin \> 150 mg daily) or analgesics
* Confinement to bed rest
* Administration of any NSAID during two days (three for oxicams) before the first administration of the trial drug
* Present treatment or treatment within the last two months with corticosteroids
* Impaired renal function (serum urea \> 125 % of the upper limit of normal range; serum creatinine \> 150 % of the upper limit of normal range)
* Sever liver injury (alanine amino transferase ALAT \> 2 x the upper normal range limit or aspartate amino transferase ASAT \> 2 x the upper normal range limit)
* Hematological disorder (platelet count \< 100,000/mm\*\*3, leucocyte count \< 3,000/mm\*\*3)
* Participation in another clinical trial during this study or the previous month
* Previous participation in this trial
* Patient unable to comply with protocol
* Bleeding disorders
CPAP Improves the Walking Capacity in Patients With COPD and OSA

We have reported that CPAP treatment improved the walking capacity of overlap syndrome patients.

However, the previous study was not randomized, double blinded study. Therefore, we design a prospective, randomized, double blinded, controlled, cross-over trial to confirm this finding.

inclusion criteria :

* COPD : FEV1/FVC \< 70%, no response to bronchodilator (FEV1 change \<12% and \<200ml)
* OSA : AHI \> 15/h, obstructive type predominant

exclusion criteria :

* any malignancy
* pregnancy
* claustrophobia
* age\<18

primary outcome : exercise capacity (walking distance (meter), measured by incremental shuttle walking test)

Method : For those fit in criteria. CPAP titration will be performed to determine the optimal pressure Baseline measurement : incremental shuttle walking test, urine catecholamine, heart rate variability, muscle power and other baseline characteristics Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement

Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC \< 70%, no response to bronchodilator (FEV1 change \<12% and \<200ml)
* OSA : AHI \> 15/h, obstructive type predominant

Exclusion Criteria:

* any malignancy
* pregnancy
* claustrophobia
* age\<18
Peer to Peer Delivery of Behavioral Activation

The goal of this study is to test the feasibility, acceptability and preliminary impact of peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally Occurring Retirement Communities (NORC) residents or senior center participants.

This project focuses on helping to solve a growing problem in health care today. Through increased screening in the older adult population, detection of depression has increased which has established a growing need for mental health resources. Unfortunately, there are limited resources to keep up with the steady increase of individuals in need. Training peers to work with older depressed adults in techniques such as behavioral activation provides an alternative model to help moderate the increased need and provide a unique intervention of care. Developing an innovative peer facilitated program has the potential to enhance the delivery of quality health care.

The specific aims of the study are 1) to train peer coaches and implement Peer to Peer in the community 2) to examine depression ratings over time.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 and older
* Member of Lenox Hill Senior Center, St. Peter's Senior Center, or Beth Abe
* Score of 10+ on Patient Health Questionnaire (PHQ-9)

Exclusion Criteria:

* Presence of alcohol abuse, substance abuse, psychotic disorder, or bipolar disorder as observed on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID)
* Inability to speak English
* Dementia: Mini Mental State Examination (MMSE) score below 24
* High suicide risk, i.e. intent or plan to attempt suicide
Study in Healthy Adult Female Subjects

An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of \[14C\] D-0502 Following Single Oral Dose Administration


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult female volunteers not of child-bearing potential between the ages of 18 and 65. Other inclusion criteria will be reviewed by the Principal Investigator.

Exclusion Criteria:

* History or presence of any condition or prior surgery that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives
* Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG, or laboratory tests
* Other exclusion criteria will be reviewed by the Principal Investigator.
Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance

The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.


Eligibility Criteria:
Inclusion Criteria:

* The subject has signed consent
* The subject must be a member or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* The subject has a cancer of the larynx:
* classified T1 or T2 in the TNM
* glottic localization and / or supraglottic regardless of node status
* with or without a history of head and neck cancer
* The subject does not have distant metastasis (M0)
* A decision for endoscopic robot-assisted surgery is retained in multidisciplinary meeting

Exclusion Criteria:

-
Exercise Trial in Chronic Kidney Disease

Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated with impairment in cognition and physical function. The purpose of this study is to test the effects of 12 months of aerobic and resistance exercise training compared to health education on cognitive and physical performance in 120 older adults with CKD not requiring dialysis. The results of this study will be essential for demonstrating the effectiveness of exercise in improving function and ultimately preventing disability in this high-risk population of older adults.

This is a parallel-group randomized controlled trial comparing 12 months of aerobic and resistance exercise training vs. health education (attention control) on neurocognitive and physical performance among community-dwelling older adults (age \>55) and CKD stage 3b and 4. Co-primary outcomes are change in physical performance (including aerobic capacity and submaximal walking) and neurocogntive performance (including executive functions).

Outcome measures will be assessed at baseline and after 6- and 12 months. Exercise training will occur thrice weekly at a dedicated research exercise center and will be supervised by exercise specialists.

Eligibility Criteria:
Inclusion Criteria:

* Stage 3-4 Chronic kidney disease (estimated Glomerular Filtration Rate 15-45)
* Age 60 to 85
* English Speaking

Exclusion Criteria:

* Dementia or cognitive impairment
* Renal transplant
* New York Heart Association class 3-4 heart failure
* Severe Chronic Lung Disease
* Unstable angina or coronary revascularization within the last 3 months
* Orthopedic problems that would preclude aerobic exercise training
* Known, untreated infection
* Disabling arthritis
* Uncontrolled arrhythmia
* More than 14 alcoholic drinks per week
Increase Surveillance for Wellness Decisions, Also to Determine Targeted Risk-reducing and Preventative Strategies

Healthcare Decisions Post-Testing On Risk Reducing, and Preventative Strategies Utilizing Wellness Lab Tests

The general design of this study is collecting data and reviewing the Principal Investigators' Standard Operating Procedures on wellness testing and changes made to their specific SOP.

Eligibility Criteria:
Inclusion Criteria:

* Must be a Medical Practitioner

  * Medical Doctor (MD)
  * Doctor of Osteopathic (DO)
  * Physician Assistant (PA)
  * Advanced Practice Registered Nurse (APRN)
  * Nurse Practitioner (NP)
* Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history.

Exclusion Criteria:

* Government-funded insurance data cannot be included in the study.
Comparison of Two Periarticular Injection Medications for Adjunctive Pain Management Following Total Knee Arthroplasty (TKA)

The Investigators aim to study the efficacy of Exparel as compared to Marcaine, taking into account pain control, narcotic consumption, narcotic-related side effects, outcomes measures, and patient satisfaction. Moreover, the Investigators plan to perform cost-benefit analysis to evaluate whether use of Exparel decreases analgesic consumption, duration of hospital stay and the need for physical therapy postoperatively, therefore, offsetting its higher price in comparison with Marcaine.


Eligibility Criteria:
Inclusion Criteria:

All patients at least 18 years old who have primary unilateral TKA for osteoarthritis performed at Thomas Jefferson University Hospital.

Exclusion Criteria:

* American Society of Anesthesiologist (ASA) score of 4 or higher
* Hepatic disease (contraindication for acetaminophen)
* Renal disease (contraindication for NSAIDs)
* Any contraindication for oxycodone, ketorolac, epinephrine, pregabalin, gabapentin, hydromorphone, Tramadol, morphine or other narcotics that are considered as part of routine postoperative pain control protocol
* Fibromyalgia
* Any contraindication for intrathecal opioid injection
* History of substance abuse during the last 2 years
* History of allergy to amide compounds
* Current consumption of monoaminoxidase (MAO) inhibitors and tricyclic antidepressant (TCA) medications
* Allergy to metabisulfite compounds
* Chronic use of opioid medications in the month prior to surgery (leads to opioid tolerance and/or opioid-induced hyperalgesia)
* Body weight\<50 Kg, BMI\>40 Kg/m2
* History of hypotension
* Patients with any surgery related complication in the first 4-6 weeks following TKA, such as infection or mechanical failure
Vitamin K2 Supplementation in Adult Episodic Migraine

Migraine is a debilitating illness and a major cause of disability in the world. It is highly prevalent, especially among women. Vitamin supplementation is a potential therapeutic option for migraines that remains largely under-explored. Several studies have shown that people with migraine tend to have higher arterial stiffness than people without migraine. Vitamin K2 deficiency is an important mediator of arterial stiffness and calcification due to decreased carboxylation of matrix Gla protein (MGP). Supplementation reverses these changes and improves vascular health in patients with end stage renal disease according to previous studies. Therefore, vitamin K2 supplementation could serve a potential role in migraine patients. The purpose of the study is to test the effect of vitamin K2 on decreasing the frequency of migraine attacks and decreasing arterial stiffness. The population will be recruited from the neurology clinic at LAU Medical Center-Rizk Hospital and will constitute of adult patients. They will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months. Laboratory tests and arterial stiffness measurements will be done at the beginning, middle, and at the end of the study for comparison.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or above
* History of episodic migraine with or without aura since \> 12 months according to the ICHD-3 criteria.
* Migraine frequency from 4-14 days per month over the 3 months prior to screening.
* Migraine frequency from 4-14 days per month during the baseline period of assessment.
* Successful completion of the migraine diary during the baseline evaluation period.

Exclusion Criteria:

* Migraine patients with superimposed tension type or other forms of primary headaches
* Patients who are currently on any of the migraine prophylactic treatments (Sodium valproate, Topiramate, Beta-blockers, Tricyclic antidepressants, SRNI, Flunarizine, Verapamil, Lisinopril, Candesartan)
* Patients who have been on any of the previously listed medications within 3 months of screening
* Patient who takes the following medications:

  * Ergotamine or Triptans \> 10 days per month
  * NSAIDs or paracetamol \> 15 days per month
  * Opioids more than 4 days per month
  * Patients on anticoagulants
* Other active chronic pain syndromes (i.e. fibromyalgia, painful peripheral neuropathy, post-herpetic neuralgia...)
* History of hypersensitivity to the vitamin K2
* History of soy protein, cheese, eggs and meat allergy
* History of thrombotic events
* Diagnosed coagulopathy or any condition related to coagulation
* Cardiovascular event in the past month
* Current or planned pregnancy
* Lactation
* Inability to tolerate oral medications
* Known intestinal malabsorption or hypomotility syndromes
* Atrial fibrillation
* Active malignancy
* Any acute illness in the past month
Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.

The aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using Osseodensification burs versus electrical mallet.

Extraction of posterior teeth in the maxilla for long time without rehabilitation of the area increases the incidence of maxillary sinus pneumatization that makes maxillary sinus enlarges in volume over the residual bone of alveolar ridge.

Decreasing the height of sub_ antral bone affects adversely on the bone density which is crucial for implant primary stability causing placement of dental implant quite challenging requiring sinus lifting procedure and bone condensation of residual ridge in addition to bone grafting

Summers technique considered the gold standard for closed sinus floor elevation using osteotome and a hand mallet to condense alveolar bone and elevate schneiderian membrane. One of drawbacks of this technique is benign paroxysmal positional vertigo due to force applied by hand mallet is not controlled.

Electrical mallet was introduced to overcome (BPPV) as it applies controlled force (daN) in short fraction of seconds(µs) with hand piece secured totally by the surgeon and have a wide variety of instruments placed on the hand piece e.g. osteotomes used in sinus floor elevation .

Controlled force of magnetic mallet decrees the risk of schneiderian membrane perforation

Osseodensification burs now show great outcomes in closed sinus lifting procedure.

Densah burs increase the density of alveolar bone which increase the primary stability of dental implants .

Aim of this study is to compare Electrical mallet with Osseodensification burs in closed sinus lifting.

Eligibility Criteria:
Inclusion Criteria:

* patients with partially edentulous posterior maxilla
* Residual bone height ≥ 5mm
* Oral hygiene : fair oral hygiene

Exclusion Criteria:

* Smoking
* Systematic disease that affects bone remodeling (e.g. uncontrolled Diabetes mellitus or osteoporosis)
* Radiotherapy to head and neck or chemotherapy
* Chronic disease of maxillary sinus
Comparing the Effects of Water Temperature and Actives in Glucose Solution on Pregnant Women

To assess the effect of water temperature and additives on pregnant women's taste and side effect during the oral glucose tolerance test (OGTT) evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Gestational age between 24 and 28 weeks

Exclusion Criteria:

* Clinical diagnosis of overt type 2 diabetes
* Clinical diagnosis of facial palsy
* Clinical diagnosis of oral cavity and throat
* Clinical diagnosis of hypothyroidism
* Clinical diagnosis of chronic hepatitis
* Clinical diagnosis of kidney disease .Clinical diagnosis of Sicca syndrome.
Study to Develop a Group-Based E-Health Intervention for YA Cancer Survivors

Investigators will test an evidence-based behavioral intervention that is responsive to Young Adults (YA's) expressed needs and priorities


Eligibility Criteria:
Inclusion Criteria:

* 18-39 years old
* Diagnosed with cancer between 18-39 years old
* Cancer diagnosis was non-metastatic
* Completed cancer treatment between 1 month and 5 years prior to enrollment, with the exception of ongoing hormone therapy
* No documented or observable psychiatric or neurological disorders that could interfere with participation (e.g., active psychosis, active substance abuse), as identified by the referring medical team, chart review, or screening
* Able to speak and read English
* Able to provide informed consent

Exclusion Criteria:

* Metastatic disease
* Continued cancer treatment
* Psychiatric or neurological disorders that could interfere with study participation
* Vulnerable populations will not be included