cyrilzakka/clinical-trials huggingface dataset:
Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)

The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).


Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed malignancy of the gynecologic tract
* Involved pelvic or para-aortic lymph nodes
* Treatment plan to include delivery of concurrent chemoradiotherapy.
* Good performance status
* Negative pregnancy test in women of child-bearing potential
* Signed study-specific informed consent
* Lab results within study specific limits

Exclusion Criteria:

* Prior radiation to the abdomen or pelvis
* A history of Scleroderma or Inflammatory bowel disease
* Contraindication to chemotherapy or radiation
Adhesive Capsulitis and Dynamic Splinting

The purpose of this study is to examine the efficacy of dynamic splinting in reducing contracture following diagnosis of adhesive capsulitis.

This randomized controlled trial will explore the efficacy of dynamic splinting in conjunction with the current standard of care as compared to standard of care alone.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 25% reduction in maximal external rotation plus greater than 25% reduction in at least one other plane of motion (elevation or abduction), as compared to the asymptomatic shoulder, measure supine with humerus abducted to 90º
* Duration from onset less than 12 months.
* Pain that is worsened by moving the arm in that direction

Exclusion Criteria:

* Any previous shoulder surgery.
* Brachial plexus injuries
* Neurologically mediated pain and fibromatosis-like contracture
* Concomitant neurologic complaints or abnormalities
* Glenohumeral impingement or mechanical blockage
* Oncological process affecting the shoulder
* Previous total mastectomy
* Glenohumeral arthritis
Group-based Chronic Kidney Disease Care

A two-group randomized clinical trial testing whether group-based care is feasible and will help improve blood pressure control in adult and adolescent patients with chronic kidney disease and hypertension.

This two-group RCT will enroll 100 subjects, adolescents over or equal to 12 years of age, and men and women over age of 21, with stage 3-4 and 5 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology. The primary aim will be to assess feasibility of the intervention.

Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.

Blood and 24 hr urine test will be collected to assess for sodium, phosphorus, and serum creatinine. These tests will be used for experimental purposes only and will be collected at enrollment and 6 months visit.

There will be two arms, an arm randomized to Group-based care attending monthly outpatient clinic visits as part of a group and the other to usual care who will see their provider once a month for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent Age ≥12 years old
* Sufficient hearing, vision, and proficiency in English or Spanish to comprehend low- literacy printed educational materials and participate in group sessions (assessed by provider)
* Adult: (¬\>21 years): Systolic blood pressure \>140 at two clinic visits in the past year or \>160 at one visit and Adolescent: (12-21 years) systolic blood pressure \>95 percentile (based on sex and age) at 2 clinic visits in the past year
* For adults: Stage 3-5 CKD (eGFR\<60 ml/min/1.73m2)
* For adolescents: evidence of kidney damage (albuminuria, congenital anomalies of the kidney or urinary tract) and hypertension
* Prescription for anti-hypertensive medication (in adults)
* Unwillingness to accept random assignment
* Unwillingness to provide informed consent

Exclusion Criteria:

* Transplanted organ
* Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
* Plans to relocate out of New York City in the next 6 months
Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients

Investigators developed a test to assess the bronchodilator effects in mechanically ventilated chronic obstructive pulmonary disease patients by comparing the change of airway resistance. No matter whether patients respond to bronchodilator or not, they are randomized assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then investigators could objectively decide whether individual patients need or benefit from bronchodilator administration.

Bronchodilator is commonly used in mechanical ventilated chronic obstructive pulmonary disease patients. It is assumed that patient's response to bronchodilator is the same during acute exacerbation or when stable whether on mechanical ventilation or not. Decision to treat is often independent of response and the patient's response to the medicine is not precisely evaluated. Investigators developed a test to assess the bronchodilator effects in mechanically ventilated chronic obstructive pulmonary disease patients by comparing the change of airway resistance. No matter whether patients respond to bronchodilator or not, they are randomized assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then investigators could objectively decide whether individual patients need or benefit from bronchodilator administration.

Eligibility Criteria:
Inclusion Criteria:

should meet all the criteria:

1. Acute exacerbated chronic obstructive pulmonary disease
2. Invasive mechanical ventilation with intubation outside ICU no more than 48 hours

Exclusion Criteria:

Meet any of the criteria:

1. Asthma
2. Tracheotomy
3. Prolonged Mechanical Ventilation (Have been mechanical ventilated for more than 21 days)
4. Unstable hemodynamic status
5. Severe pneumonia
6. Contraindication for bronchodilator
7. Contraindication for sedation
8. Refusal to participate in study
9. Re-intubation in 48 hours
10. Mental disorder, could not understand and accomplish pulmonary function test
A Multislice Computed Tomographic Study of the Sphenoid Sinus

•Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures .Detailed, meticulous preoperative radiological study of sphenoid sinus is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons

Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures such as the optic nerve, optic chiasm, cavernous sinus, pituitary gland, and internal carotid artery. Detailed, meticulous preoperative radiological study of sphenoid sinus variations as in Onodi cells (Sphenoethmoidal air cell) is an anatomical variant of the paranasal sinuses, important due to its close proximity to the optic nerve and internal carotid artery. , Pnumatization pattern as the extent of pneumatization is highly variable and potentially jeopardizing to surrounding vital structures , Septation pattern , Intercarotid distance (in millimeters), Bony covering of carotid artery, Bony covering of optic nerve.is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons

Eligibility Criteria:
Inclusion Criteria:

* patients with free sphenoid sinus

Exclusion Criteria:

* pathology in the sphenoid sinus
* refusal of patients for inclusion in the study
Abscopal Effect of Radiotherapy in Combination With rhGM-CSF for Advanced Thymic Epithelial Tumours

The purpose of this study is to determine whether radiotherapy (RT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of patients with advanced thymic epithelial tumours.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Histologically proven thymic epithelial tumours；
3. Stage IV according to UICC stage system(version 8,2017), at least with two evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）;
4. Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);
5. ECOG performance status: 0-1;
6. Life expectancy ≥ 3 months.
7. Adequate baseline organ and marrow function: absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
8. Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;
9. Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;
10. Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.

Exclusion Criteria:

1. Having received immunotherapy within 4 weeks prior to inclusion;
2. Allergic to GM-CSF, INF-α2b or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one;
3. Receiving treatment of other trials;
4. Any unstable systemic disease, including active infection, symptomatic congestive heart failure,myocardial infarction onset six months before included into the group, unstable angina, and severe arrhythmia, uncontrolled chronic lung disease;
5. Unwilling to sign consent;
6. Women in pregnancy or lactation;
Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD

Use of beta-blockers has proven beneficial in patients with hypertension, heart failure, and in people who have suffered a heart attack. The use in patients who have Chronic Obstructive Pulmonary Disease (COPD) and reactive airway disease, however, has been limited due to possible side effects such as worsening of lung function or increasing airway spasms and asthma attacks. The purpose of this study is to find out if patients with COPD can tolerate being on a beta-blocker at doses recommended for the treatment of heart disease conditions. This study also seeks to find out if a selective beta-1 receptor beta-blocker is better than a non-selective beta-blocker in patients with mild to moderate COPD.


Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or older
* Mild to moderate COPD as defined by the American Thoracic Society
* Current treatment with a beta-blocker for either hypertension, myocardial infarction, or congestive heart failure.

Exclusion Criteria:

* Recent (within 30 days) COPD exacerbation or requirement for oral steroid therapy within the last 6 months
* Any history of ventilator support requirement for COPD
* Patients with asthma or reactive airway disease (RAD) defined as obstructive lung disease with a \>15% improvement in FEV1 with beta-agonist therapy
* Relative or absolute contraindication to beta-blocker therapy
* Exposure to any investigational drugs within the previous 30 days
* Patients with any concurrent disease or condition, which in the judgment of the investigator would make the patient inappropriate for participation in the study were excluded from this study
A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity

This is a multicenter, randomized, placebo-controlled, double-blind, Phase 2 study. Patients will be treated for a total of 12 weeks. There will be a 6 week follow-up period after the treatment period ends. Patients will be randomly assigned to low dose CJC 1295, high dose CJC 1295 or placebo.

The objective is to assess and compare the efficacy, pharmacokinetics, safety, and tolerability of CJC 1295 in patients with human immunodeficiency virus (HIV) associated visceral obesity.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 on stable antiviral regimen
* Documented HIV infection
* HIV associated visceral obesity
* Body mass index (BMI) \> 24 and \< 30 kg/m2

Exclusion Criteria:

* Diabetes
* Use of growth hormone (GH) or other GH secretagogues
* Use of systemic glucocorticoids,
* Use of megestrol acetate or other appetite stimulants,
* Use of general anorexigenic or weight-reducing agents, or
* Use of androgens, other than testosterone replacement therapy for male hypogonadism at physiological doses and on a stable regimen for at least 6 months prior to randomization.
Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery

This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery


Eligibility Criteria:
Inclusion Criteria:

* Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters

Exclusion Criteria:

* Dry eye signs and symptoms
* Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
* Pregnancy or planning pregnancy
* Uncontrolled systemic disease
* Use of systemic medications affecting dry eye
Perioperative Lung Ultrasonography for Fast-track Cardiac Surgery

The investigators evaluate the usefulness of lung ultrasonography in the perioperative period for postoperative outcomes in children undergoing fast track cardiac surgery.

Some appropriate intervention such as recruitment maneuver, chest tube insertion, or diuretics will be applied depending on lung ultrasound findings.

Eligibility Criteria:
Inclusion Criteria:

* Children receiving fast track cardiac surgery protocol
* = or \< 5 years old
* Children with acyanotic heart disease

Exclusion Criteria:

* Previous history of lung resection surgery
* Preoperative chest x-ray abnormalities
* Postoperative cyanosis
Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age

The goal of the investigators research is to explore energy production of the ovarian follicle in older reproductive age women at the time of oocyte retrieval.


Eligibility Criteria:
Inclusion Criteria:

* Age 38-43 years at the time of enrollment
* Diagnosis of primary infertility

Exclusion Criteria:

* Body mass index (BMI) \> 30 kg/m2
* Early follicular phase (day 2-4) serum FSH level \> 20 mIU/ml.
* Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
* Any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment.
* Any contraindication to being pregnant and carrying a pregnancy to term.
* Contraindication for the use of CoQ10, or fertility medications.
* Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.
* Absence of one or two ovaries
* Clinically relevant systemic disease (e.g., Insulin-dependent diabetes, adrenal dysfunction, organic intracranial lesion, polycystic ovarian syndrome, hyperprolactinemia, or hypothalamic tumor) or serious illness (Neoplasia).
* History (within past 12 months) or current abuse of alcohol or drugs.
* Administration of any investigational drugs within three months prior to study enrollment.
* Any medical condition that may interfere with the absorption, distribution, metabolism or excretion of the study drugs, gastrointestinal diseases, mal absorption syndromes and liver dysfunction
* Unexplained gynecological bleeding.
* Ejaculated sperm is not sufficient for ICSI
* Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
* Abnormal COH screening blood done for both partners, including: prolactin, thyroid stimulating hormone, HIV serology, Hepatitis B and C serology, Rubella, group and screen and syphilis serology prior to participation in study.
* Unwillingness to give written informed consent. Previous entry into this study or simultaneous participation in another clinical trial.
* The concurrent use of any of the following drugs:
* Daunorubicin, Doxorubicin, Blood Pressure Medications, Warfarin, Timolol, atorvastatin, cerivastatin, lovastatin, pravastatin, simvastatin gemfibrozil, tricyclic antidepressant medications (including amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine) multivitamins or any vitamin supplementation except Folic acid.
FFA Hypertension and Inflammation in Lean and Obese Subjects

Although a large number of obese patients develop high blood pressure, the cause is unknown. The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the development of high blood pressure in obese people.

Recent studies indicate that increased levels of a circulating fat (free fatty acids or FFAs) increases blood pressure, impairs endothelial (vascular) function, and increases inflammatory markers in subjects with and without diabetes. The effects of FFA on blood pressure and vasculature have not been fully investigated. A group of 12 obese nondiabetic, normotensive subjects will be admitted to the Grady Clinical Research Center (GCRC) on separate 4 occasions. Research subjects will receive, in random order, a 8-hour intravenous (IV) infusion of Intralipid 20% at 40 mL/h (a fat solution), 8-hour IV infusion of normal saline at 40 mL/h, 8-hour IV infusion of dextrose (sugar) 10% at 40 mL/h, and a 8-hour intravenous (IV) infusion combination of Intralipid 20% and dextrose 10% at 40mL/h.

Eligibility Criteria:
Inclusion Criteria:

* Males or females
* Obese subjects (body mass index (BMI) ≥ 30 kg/m\^2)
* 18 and 65 years
* Blood pressure reading \< 140/80 mm Hg and no prior history of hypertension

Exclusion Criteria:

* History of diabetes mellitus
* History of hypertension
* Fasting triglyceride levels \> 250 mg/dL
* Liver disease (ALT 2.5x \> upper limit of normal)
* Serum creatinine ≥1.5 mg/dL
* Smokers, drug or alcohol abuse
* Mental condition rendering the subject unable to understand the scope and possible consequences of the study
* Female subjects who are pregnant or breast feeding
Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction

Anterior cruciate ligament (ACL) injuries account for up to 25% of knee injuries, it is estimated that 32,000-400,000 new cases of ACL tears occur in the USA every year.

The Standard care is twofold; a) ACL reconstruction surgery and b) prolonged rehabilitation period (usually no less than 9 months). However, a large amount of patients do not return to their pre-injury activity level, and up to 30% reinjure their ACL in the following two years.

The wearable system consists of two non-invasive bands, above and below the knee that vibrate during the weight bearing phase while walking.

The objective of this study is to investigate the effect of treatment for ACL reconstruction, including vibrational stimulation and pressure, on locomotion tasks (i.e. walking, stair ascending and descending), muscle function, and pain/function.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Males and females
* Aged 18-50
* Scheduled for an ACL reconstruction in Rambam hospital.
* Hebrew language at mother tongue level

Exclusion Criteria:

* Inability to understand the study protocol.
* Known neuropathies, active cancer, previous fractures in the lower limbs, inflammatory arthritis, implanted electronic devices of any kind.
* Allergies to silver or adhesives.
An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Positive ELISA test confirmed by Western blot analysis.
* Asymptomatic.
* Willing to sign an informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
* Oral hairy leukoplakia at any time prior to entry.
* Temperature \> 37.8 C.
* Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
* Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
* Unwilling to sign an informed consent.
* Zidovudine induced hematological toxicity.

Prior Medication:

Excluded:

* Therapy with antiretroviral drugs or immunomodulators within seven days before entry.
* Therapy with any investigational drug during the preceding 30 days.

Patients may not have:

* Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
* Oral hairy leukoplakia at any time prior to entry.
* Temperature \> 37.8 C.
* Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
* Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
* Unwilling to sign an informed consent.
* Zidovudine induced hematological toxicity.
Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

The primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive extended reality (XR) headset to engage in behavioral activation (BA) for individuals diagnosed with major depressive disorder (MDD). The secondary aim of this study is to explore the efficacy of using XR to enhance BA therapy in a clinical MDD population.

This is a treatment development trial. Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation. All groups will follow a brief-BA protocol developed for primary care settings over a four-session, three-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Patient must meet DSM V criteria for MDD
* Patient must be at least 18 years of age
* Patient must be English speaking

Exclusion Criteria:

* Substance Use Disorders in past year
* Any psychosis or bipolar disorder
* Any seizure in the last 6 months or untreated epilepsy
* Current nonsuicidal self-injury or parasuicidal behavior
* Current suicidal urges and intent
* Changing psychotherapy treatment within four months of study entry
* Changing psychotropic medication(s) within two months of study entry