cyrilzakka/clinical-trials huggingface dataset:
Parameters Related to Physical Activity Level in SCI

Spinal cord injury (SCI) is a devastating health condition associated with permanent disability and reduced life expectancy. It is stated that its annual incidence worldwide varies between 12.1 and 57.8 per million, and its prevalence varies between 236 and 1009 per million.

SCI negatively affects the physical, psychological, and social well-being of individuals by causing sensory, motor, and autonomic dysfunction. The level of disability associated with SCI is different for each injury and varies depending on the level and type of injury. However, physical activity (PA), cardiovascular fitness, and respiratory system are commonly observed to be affected in most individuals with SCI.

Due to inadequate control of somatic and autonomic systems, a decrease in the cardiovascular response to PA and exercise occurs. A decrease in PA level and systemic disorders after injury promote sedentary behavior and negatively affect cardiovascular fitness in individuals with SCI. Cervical and thoracic spinal cord injuries compromise the function of the respiratory muscles and significantly impair both inspiratory and expiratory function. It also interrupts the sympathetic innervation of the lungs and creates restrictive changes in the physiological and mechanical properties of the lungs. The broad effects of SCI on lung capacity may have implications for cardiovascular fitness. Adequate ventilation is critical to provide adequate oxygen to working muscles during prolonged physical activities. During moderate and high-intensity physical activities, ventilation increases in proportion to oxygen consumption to maintain arterial oxygen concentration and allow continuous PA.

Knowing the relationship between PA, cardiovascular fitness, and respiratory parameters after SCI is essential in guiding the course of rehabilitation after SCI. Battikha et al. They reported that respiratory capacity plays an important role in limiting exercise capacity in individuals with SCI. However, the relationship between PA and cardiovascular fitness and respiratory parameters has not been fully examined in individuals with SCI.

In this study, the investigators hypothesize the relationship between PA, cardiovascular fitness and respiratory parameters. Accordingly, this study aims to determine the relationship between PA, cardiovascular fitness and respiratory parameters in individuals with SCI.


Eligibility Criteria:
Inclusion Criteria:

* Classified as group A, B, C or D (diagnosed with spinal cord injury) according to the American Spinal Injury Association (ASIA),
* Fully or partially wheelchair dependent
* Having the upper extremity muscle strength required to use a wheelchair
* Those who are over 18 years old
* Patients without cognitive impairment

Exclusion Criteria:

* Those with any progressive disease
* Bedridden,
* Patients with severe cognitive impairment
Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice

The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysterosalpingography diagnostic practice.


Eligibility Criteria:
Inclusion Criteria:

* patients that must perform a hysterosalpingography
* acceptance to participate in the study signed informed consent

Exclusion Criteria:

* hypersensitivity or allergy to anesthetics
* refusal of the patient
* patients under age 18 years old and pregnant
* unbearable pain that involves other analgesic measures
Vaccine Responses in Patient with Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment

This study evaluates immune responses after CAR-T therapy to find out if CAR-T therapy reduces the effectiveness of the vaccines (vaccine immunity) against diseases such as measles, mumps and rubella, among others in patients with multiple myeloma and non-Hodgkin lymphoma.

PRIMARY OBJECTIVES:

I. To assess positive VPD antibody (Ab) titers prior to and at 6 months after CAR-T therapy to evaluate the impact of CAR-T on immune responses in patients undergoing CAR-T therapy.

II. To assess the change in Ab titer to S. pneumoniae and tetanus at 6 months and 1 year post-vaccination and evaluate if titer increases are correlated to post-vaccination CD4+ count and IgG level.

OUTLINE: This is an observational study.

Patients may receive up to 3 doses of pneumococcal and/or tetanus vaccine per institutional policy of revaccination. Patients undergo blood sample collection and have medical records reviewed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* \* Willingness to provide written informed consent before any study-specific procedures or activities are performed

  * Age ≥ 18 years of age, at the time of consent
  * Documented, histologically or cytologically confirmed diagnosis of multiple myeloma (MM), diffuse large B cell lymphoma (DLBCL),follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), or primary mediastinal B cell lymphoma (PMBL). All number of prior lines of therapy are allowed
  * History of prior vaccination against common VPD
  * Approved by managing physician for CAR-T therapy, with preparative conditioning planned within the next 90 days
  * Approved by managing physician for revaccination against Streptococcus pneumoniae or tetanus

Exclusion Criteria:

* \* Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints

  * Uncontrolled, intercurrent illness including, but not limited to, systemic infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or make the study procedures unadvisable
Use of TENS Unit in the Management of Endometriosis Pain

The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.

The investigators propose to conduct a cross-over clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-month "baseline" period (no TENS unit use for endometriosis flares) and then cross-over to a 3-month "treatment" period (TENS unit use for endometriosis flares).

Potential subjects will be pre-screened in the Penn State Minimally Invasive GYN (MIGS) Surgery Clinic for pathologically diagnosed endometriosis and from the Penn State MIGS endometriosis database. Potential subjects will then be called to evaluate the remainder of the inclusion and exclusion criteria. If fulfilled, potential subjects will follow up at the enrollment visit (Visit 1) where consent is reviewed and signed. The baseline QOL and FSFI REDCap surveys will be completed at this visit. Subjects will be set up to receive automated links to complete diary entries and surveys directly in REDCap.

Prior to initiating TENS unit use for endometriosis flare-related pain, subjects will record daily entries into RedCap during episodes of endometriosis flares for 3 months. Each entry will record their VAS pain score as well as medication intake and bleeding profile.

Subjects will then be mailed the TENS unit at the 3 months mark into the study. Subjects will then complete entries with TENS use at their discretion for the following 3 months and record TENS unit use duration, frequency, and side effects in addition to the documentation of pain, medication and bleeding. At the end of the study, subjects will complete a QOL and FSFI survey.

Eligibility Criteria:
Inclusion Criteria:

1. Females ages 18-45 years at time of enrollment
2. A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
3. Average monthly endometriosis pain flare
4. Naïve TENS user

Exclusion Criteria:

1. TENS device exclusion:

   1. Implantable devices (pacemaker, Interstim, etc.)
   2. Cardiac arrhythmia
   3. Open skin sores over areas of placement
2. Pregnancy
3. Nursing or trying to conceive at this time
4. Post-operative \<12 weeks from abdominal or pelvic surgery
5. Planned surgery or hormonal medication changes for duration of study if applicable
6. Non-English speaking or inability to read and understand English
7. Prisoners
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.

OBJECTIVES:

Primary

* To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer.

Secondary

* To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens.
* To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.

OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
* Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires

Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.

After completion of study treatment, patients are followed for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer
* T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
* Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
* Age \>= 18

Exclusion Criteria:

* Prior thoracic radiation therapy
* T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
* Node positive or metastatic disease
* Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
* No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
* Pregnant or unwilling to use adequate contraception
An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin

This is a single center, prospective, randomized, placebo -controlled, parallel design and double blind study to evaluate oxidative stress, inflammation and hypertension markers and mediators before and after treatment with dapagliflozin.

Two groups of 26 patients each (total 52 patients) with type 2 diabetes on oral agents will be included in the study. One group will be randomized to dapagliflozin (a dose of 5 mg daily will be titrated to 10 mg daily during the first week) while the other will be placebo. The patients will be treated for 12 weeks. Only half the patients (equal numbers in both groups) will be tested for the secondary endpoints related to postprandial and single dose induced changes. The primary endpoint of the study is to detect a significant difference in the percent change in fasting Nuclear factor-k B (NFκB) activation (DNA binding activity) in mononuclear cells (MNC) before and after dapagliflozin use (0 week vs. 12 weeks) as compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80 years inclusive.
* Type 2 diabetes
* BMI ≥30 kg/m2
* Subjects on statins, ACE inhibitors, ARBs, thiazolidinediones and -antioxidants will be allowed as long as they are on stable doses of these -compounds and the dosage in not changed during the course of study. -Patients will be evenly distributed between the 2 groups based on statins, -ARBs, TZDs and ACE inhibitors use.
* HbA1c ≤ 8.0%

Exclusion Criteria:

* Use of GLP-1 agonists or DPP-IV or SGLT-2 inhibitors therapy in the last 3 -months.
* Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and -hypertriglyceridemia.
* Coronary event or procedure (myocardial infarction, unstable angina, coronary -artery bypass, surgery or coronary angioplasty) in the previous 3 months.
* Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver -function defined as:
* aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or -alanine aminotransferase (ALT) \>3x ULN
* Total bilirubin \>2.0 mg/dL (34.2 µmol/L)
* Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
* (liver function tests more than 3 times the upper limit of normal)
* Renal impairment (serum eGFR \<60 ml/min)
* Any other life-threatening, non-cardiac disease
* Uncontrolled hypertension (BP \> 160/100 mm of Hg)
* Congestive Heart Failure class III or IV.
* Use of an investigational agent or therapeutic regimen within 30 days of study
* Participation in any other concurrent clinical trial
* pregnant or breastfeeding patients
* Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics
Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors

The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years
* Ovarian cancer patients with at least five tumor samples does not affect the diagnosis, based on other tumor masses
* Surgery of any initial chemotherapy naive
* Patient information and signed informed consent

Exclusion Criteria:

* A person deprived of liberty or under guardianship
* Insufficient tumor samples of ovarian cancer.
Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia

Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital. This type of anesthesia reduces the average arterial pressure. Benefits include reduced bleeding and lower risk of blood clots.

The purpose of this study is to determine the effect of intravenous fluids administered with hypotensive anesthesia on your blood volume. With this parameter we will be able to understand how much of your blood is lost because of bleeding and how much of the drop is related to dilution.

Study hypothesis: Hemodilution associated with intravenous fluid substitution during hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels

Recent technology allows the measurement of patients' total blood volume with 98% accuracy within 90 minutes or less. This is key to understanding the effect of hypotensive anesthesia on patients undergoing total hip arthroplasty. The drop in blood pressure enhances the dilutional effect of intravenous fluid given during the procedure. Increases in TBV could result in decreases of postoperative hemoglobin. Understanding the effect of hypotensive anesthesia on postoperative hemoglobin levels and TBV will enhance our understanding of postoperative blood management and transfusion triggers.

Eligibility Criteria:
Inclusion Criteria:

* Non- inflammatory degenerative joint disease of the hip
* Patients scheduled for unilateral primary total hip arthroplasty
* Age between 50 and 75 years
* Hypotensive Spinal-epidural anesthesia with systolic BP \< 95 and diastolic BP \< 65.
* Adequate intraoperative fluid loading: a minimum of 3 L within 6 hours of surgery

Exclusion Criteria:

* Pregnant women or nursing mothers.
* Women of childbearing potential not using adequate birth control methods
* Known hypersensitivity to I-131 albumin or any other component of the Volumex injection kit
* Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
* Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
* Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
* Congestive Heart Failure (at least one medication to treat congestive heart failure)
* Coronary artery disease (s/p bypass, stent or AMI)
* Kidney insufficiency (creatinine \> 1.5)
* Aortic or mitral valve disease
* Pulmonary hypertension
* Revision Hip Surgery
* Inadequate intravenous fluid substitution within the first 6 hrs (\<3 liters)
* Inadequate hypotensive anesthesia (mean arterial pressure above 65 for more than 33% of the surgical time
Effect of Premedication Type on Preoperative Anxiety in Children

Compare the effects of pharmacological and nonpharmacological premedications on preoperative anxiety and mask acceptance after adenotonsillectomy

Compare the effects of 0.5 mg/kg oral midazolam, watching film 'Suko is being operated' animation film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU , playing smartphone game ( subway surfers, snail Bob or angry birds) on preoperative anxiety by m-YPAS in the holding area, in the operating room and while induction of anesthesia.

Investigators also evaluated mask acceptance by Mask Acceptance Scale Investigators also evaluated post operative delirium by PAED (postanesthetic emergency delirium) scale at PACU at arrive and every 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* Elective surgery

Exclusion Criteria:

* Chronic diseases
* Development disability
* Prematurity
* Neurological diseases
* Psychoactive medication use
* Hearing/visual impairment
* History of surgery
Effect of Samples on Acne Treatment With Epiduo® Gel

The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel in patients with mild to moderate acne who receive a medication sample and instructions on proper application with their stock size medication tube versus patients who receive only the stock size medication tube.

Adapalene Topical Gel is a Vitamin A type product in a water-based gel that is applied to the skin. It is approved by the United States Food and Drug Administration (FDA) for the treatment of acne. Benzoyl Peroxide is a medication applied to the skin that is also approved by the FDA for the treatment of acne and has anti-bacterial properties.

The purpose of this study is to evaluate the safety and effectiveness of a drug called Epiduo® Gel 0.1%/2.5% for the treatment of acne vulgaris.Epiduo® is a combination of adapalene and benzoyl peroxide. This combination drug is approved by the FDA for sale in the United States for use in individuals with acne who are over the age of 12.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject with mild to moderate acne, aged 12 and older, who agrees to participate and provides written consent.
* Have an Acne Global Assessment (AGA) of mild to moderate acne (an AGA score of 2 or 3)

Exclusion Criteria:

* Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
* Subjects with known allergy or sensitivity to Epiduo® Gel (or Benzoyl Peroxide Gel) or components therein, including adapalene or benzoyl peroxide
* Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), Depo-Provera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer

The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer.

This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.

Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Untreated, stage IIIB with pleural effusion
* Untreated, Stage IV, non-small cell lung cancer
* Recurrent after surgery if no previous radiation therapy or chemotherapy were administered as part of their primary treatment, except for palliative radiotherapy
* 18 years of age or older
* ECOG PS 0, 1 or 2
* At Least one target lesion according to the RECIST Criteria
* Adequate organ and marrow function

Exclusion Criteria:

* Previous cancer history unless they have had curative treatment completed at least 5 years prior to entry.
* No previous radiotherapy, chemotherapy or immunotherapy for NSCLC, except for radiation therapy to the brain to control metastasis, bone to control pain, or lung to relieve bronchial obstruction.
* No radiation therapy for any previous cancer to more than 25% of bone marrow.
* Uncontrolled, intercurrent illness
* Non-study corticosteroids
* Pregnant women
* Peripheral neuropathy greater than grade 1
* Uncontrolled seizures, central nervous system disorders
* Major surgery within 4 weeks of the start of study treatment
* Lack of complete recovery from major surgery.
* Glaucoma
* Lack of physical integrity of upper gastrointestinal tract, inability to swallow tablets
* Severe acquired or hereditary immunodeficiency
* Patients with brain metastases must receive definitive treatment (radiation, surgery or both) and be clinically and radiologically stable for 4 weeks \& off corticosteroids for at least 2 weeks prior to randomization.