cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea

The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.

Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.

Eligibility Criteria:
Inclusion

* Age\>19
* Premenopausal
* Moderate or severe dysmenorrhea, mainly in low abdomen area

Exclusion

* Pregnant
* Surgery history on lower abdomen
* Recent history of cancer
* TENS device use is contraindicated
* Ibuprofen use is contraindicated
Intranasal Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the PED

This will be a descriptive cohort study of intranasal ketamine as the initial analgesic for children with sickle cell disease who present to the pediatric emergency department with vaso-occlusive crisis and are awaiting intravenous line placement.

This will be a prospective observational cohort involving patients 3 to 25 years of age who present to the Pediatric Emergency Department (PED) at Jacobi Medical Center with vaso-occlusive episode (VOE) in moderate-severe pain (FACES or numeric rating scale ≥5) as determined at triage. Currently, the standard of treatment for VOE at our institution is intravenous (IV) line placement and IV opioid analgesia. The patient will receive intranasal (IN) Ketamine as the first parental analgesic, so as to provide more immediate pain relief while they wait for IV placement and IV analgesia, for opioid pain control, which is currently the standard of care at our institution. The primary objective of this study is to describe the analgesic effect of IN ketamine in treating moderate-to-severe pain due to VOE in the pediatric ED as measured by a pain scale rating at various time intervals following administration. Secondary objectives are to describe the effect of IN ketamine on the need for additional doses of opioid medications, patient satisfaction and disposition.

Eligibility Criteria:
Inclusion Criteria:

* History of Hemoglobin SS or SC disease
* Age 3 years old to 25 years old presenting to the PED with vaso-occlusive with moderate-severe pain determined at triage as pain score (FACES or numeric rating scale) ≥ 5
* Parent or patient willing to provide consent/assent
* English speaking

Exclusion Criteria:

* Patient with concern for more severe complications including acute chest, splenic sequestration, sepsis, stroke, non-VOC pain, asthma exacerbation
* Allergy to ketamine
* GCS\<15
* Obstructive nasal anatomy as per parent history
* History of a psychiatric disorder
* Pregnant patients will be excluded. Female patients \> 12 years old are routinely tested for pregnancy in our PED. Patients found to be pregnant will not be enrolled in study.
Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging

This work seeks to develop, evaluate and use new MRI methods for non-invasive quantitative assessment of myocardial perfusion and perfusion reserve (MPR), and to compare with quantitative PET imaging.

This project aims to determine the validity of quantitative MRI perfusion methods by comparison with quantitative PET imaging. First pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson. After custom reconstruction and post-processing the data will be fit to a compartment model and quantitative perfusion and MPR values obtained.

On another day, the subjects will have quantitative PET imaging with O-15 labeled radioactive water. This will be done at rest and hyperemia caused by either adenosine or regadenoson. A low dose CT scan will be acquired to perform attenuation correction of the PET images. The images will be reconstructed and processed as reported in the literature to provide reference standard perfusion and MPR values. These values will be compared with those obtained by MRI.

Eligibility Criteria:
* Inclusion Criteria:

  * All participants will be over the age of 18 and able to provide consent
  * Both healthy and subjects with cardiac disease (including atrial fibrillation but not required) will be recruited.
* Exclusion Criteria:

  * Critically ill patients, patients on ventilators, patients with unstable angina or with hypotension, asthmatics, and other patients whose medical care or safety may be at risk from undergoing an MRI examination will be excluded.
  * Patients with claustrophobia will also be excluded from the study if this cannot be controlled with standard methods (valium or benadryl).
  * Patients with contraindication to MRI (pacemaker, metal implants, or certain types of heart valves),
  * pregnant patients, minors, mentally disabled patients and prisoners will be excluded from this study. (All criteria apply to patients and normal volunteers).
  * Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidney function (GFR\<30) excluded from the study due to the (very small) risk associated with gadolinium contrast agents. This threshold may be modified, depending on practices determined by the Radiology Department and the IRB.
  * Patients with a known allergy or contraindication to Adenosine and/or Regadenoson will be excluded from stress (hyperemia) cohorts.
  * All participants that will receive a stress agent will refrain from consuming caffeine for at least 12 hours prior to each study
Relations Between Residual Renal Function and Oxidative and Carbonyl Stress in Peritoneal Dialysis Patients

Residual renal function is reported to contribute to the survival and cardiovascular disease of peritoneal dialysis patients. Oxidative and carbonyl stress are increased in peritoneal dialysis patients and are associated with cardiovascular risk. The aim of this study was to determine the relations between residual renal function and oxidative and carbonyl stress in peritoneal dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* chronic renal failure on peritoneal dialysis

Exclusion Criteria:

* malignancy, peritonitis
Placental Transfusion Effect on Hemodynamics of Premature Newborns

The objective of this study is to perform ultrasound Doppler measurements to evaluate the hemodynamic changes associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life.

This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Premature neonates ≤ 32 weeks gestational age regardless birth weight who will be admitted to neonatal intensive care unit in the first day of life.

Exclusion Criteria:

* Preterm babies \>32 weeks
* Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).
* Evidence of head trauma causing major intracranial hemorrhage.
* Monochorionic multiples.
* Concern for abruptions, placenta previa or retroplacental hematoma.
* Cord accident, or avulsion at the time of delivery.
* Refusal to perform the intervention by the obstetrician
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease

This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is designed to determine the effects of BLI-1300 ointment on perianal pain associated with active Perianal Crohn's Disease (PCD).


Eligibility Criteria:
Inclusion Criteria:

* All subjects must give written informed consent.
* Male or female subjects, 18 years of age.
* Confirmed diagnosis of Crohn's Disease.
* Subject must have a 3 month documented history of perianal Crohn's Disease (PCD) and with clinical evidence of active PCD.
* Subject must have a Crohn's Disease Activity Index (CDAI) total score of ≤ 350 at Visit 2.
* Subjects must have a qualifying perianal pain score at Visits 1 and 2.

Exclusion Criteria:

* Women of childbearing potential who are not using adequate contraception.
* Women who are pregnant or breastfeeding.
* Subjects on unstable regimens of Crohn's therapy (e.g. tumor necrosis factor (TNF) inhibitors, immunosuppressants, steroids).
* Subjects taking strong analgesics that could interfere with pain measurements. Subjects with a perianal abscess requiring incision and drainage.
* Subjects with anal stenosis.
* Subjects with fistulae outside the immediate perianal area.
* Subjects who have had abdominal surgery for Crohn's disease within the past 12 weeks.
* Subjects who have had significant anorectal surgery for Crohns disease within the past 8 weeks.
5 Years Follow-up With Adjuvant Therapy for Women With Breast Invasive Carcinoma

Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population.


Eligibility Criteria:
Inclusion Criteria:

* Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy
* Women with breast invasive carcinoma positive-RH and indication of adjuvant hormonal therapy
* Adult patients
* Being capable and agree to follow the study procedure
* Patients informed and non-opposed
* Covered by social security

Exclusion Criteria:

* History of other cancer except basal cell carcinoma
* Patients with breast invasive carcinoma negative-RH
* Synchronous metastases
* Relapsed
* Previous adjuvant hormonal therapy
* Men
* Patients with guardianship
Esophageal Atresia: Metaplasia, Barrett

The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux disease. Because gastroesophageal reflux disease plays a major role in the development of BE by causing repeated mucosal damage, development of BE is a concern even in children and young adults in this specific population. The aim of this study is to assess the prevalence of BE (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had been treated for EA in early infancy. All eligible patients received upper gastrointestinal endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological suspicion of metaplasia was confirmed centrally.


Eligibility Criteria:
Inclusion Criteria:

* Medical history of esophageal atresia (all types, Ladd's classification)

Exclusion Criteria:

* No medical history of esophageal atresia
* Non acceptance to participate from the patient and/or his parents
* esophageal atresia treated with esophageal replacement (e.g., coloplasty, gastric transposition)
A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)

The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.

This trial will include two separate stages (Ia+Ib and II).

Stage Ia will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recFSH provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Stage Ib will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose hCG provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Stage II is open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose FSH (n=20) or hCG (n=20) provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Oligomenorrhea (average cycle length ≥35 days and \<6 months)
* Amenorrhea (average cycle length ≥6 months)
* Body Mass Index ≥18 and ≤30 kg/m\^2
* Normal serum FSH levels and normal estradiol levels at screening
* Progestagen induced withdrawal bleeding
* Age ≥18 years and ≤39 years at the time of signing informed consent
* Willing and able to sign informed consent

Exclusion Criteria:

* History of or current ovarian cysts or enlarged ovaries not related to polycystic ovarian syndrome (PCOS)
* History of or current tumors of the ovary, breast, uterus, pituitary or

hypothalamus

* Less than 2 ovaries
* Undiagnosed vaginal bleeding
* Any ovarian and/or abdominal abnormality interfering with ultrasound

examination

* Malformations of the sexual organs incompatible with pregnancy
* Pregnancy or lactation
* Abnormal serum endocrinology levels based on screening sample
* Any clinically relevant abnormal laboratory value based on screening sample
* Alcohol or drug abuse within the 12 months preceding signing of informed consent
* Hypersensitivity to any of the substances in corifollitropin alfa
* Hypersensitivity to hCG/ Puregon® or any of its components
* Previous use of corifollitropin alfa
* Use of any investigational drug during 90 days before screening
miRNAs in High Grade Serous Ovarian Cancer

High grade serous ovarian cancer represents the gynecological malignancy with the highest incidence of mortality. Decision-making tools are currently limited to the use of standard imaging modalities and analysis of serum biomarkers, such as CA 125, which often have low specificity and sensitivity. Recently, a growing research interest has been aimed at so-called circulating microRNAs (miRNAs). Indeed, it has been observed that miRNAs are abundantly present in all biological fluids and play the key role of messengers in intercellular communication. Cancer cells have a rapid turnover which results in a continuous release of nucleic acids and vesicles derived from the tumor itself, such as the tumor cells themselves that separate from the tumor mass to enter the bloodstream. Given their important role as modulators of gene expression, in order to preserve their integrity, miRNAs are encapsulated in specific vesicles, in order to prevent their degradation by the enzymes present in biological fluids. In this context, the chance of monitoring the expression levels of specific miRNAs represents a very interesting option both for an early diagnosis and for monitoring the clinical response to pharmacological treatment. Currently, there are no non-invasive approaches to monitor the clinical outcome in real time, while the identification of circulating biomarkers would allow prompt intervention, possibly modifying the pharmacological management in case of progression.


Eligibility Criteria:
Inclusion Criteria:

* age\>18
* Histological diagnosis of epithelial ovarian cancer
* Patients eligible for surgery
* Patients followed in the clinical care pathway c / o oncological gynecology (surgery and follow up)
* informed consent

Exclusion Criteria:

* Patients with HCV, HBV and HIV
* Patients with other malignancies diagnosed less than 5 years prior to the diagnosis of ovarian malignancy
* Ovarian metastases of primary neoplasms of other organs
* Presence of ascites for non-neoplastic causes
Potential Benefits of Radiotherapy in Prone Position for Breast Cancer Patients: a Planning Study

This study has the purpose to investigate the benefit of treating breast cancer patients in prone position. This treatment is compared to the standard technique in our center (supine position with or without respiratory gating). The investigators want to compare the doses on the organs at risk (heart and lungs) in the different techniques.


Eligibility Criteria:
Inclusion Criteria:

* indication for radiotherapy of the breast and /or lymph nodes

Exclusion Criteria:

* none ( planning study)
Medical Data Collection of Patients with Head and Neck Cancer Treated with Proton Therapy

This trial collects medical information from patients with head and neck cancer that have received or are scheduled to receive proton therapy. Collecting and analyzing medical information from patients may provide information on the outcomes and treatment related side effects of proton therapy for head and neck cancer and help doctors improve therapy for future patients with head and neck cancer.

PRIMARY OBJECTIVE:

I. To evaluate the outcomes in patients who have received treatment for their head and neck malignancy with proton radiation therapy.

OUTLINE:

Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Patients documented to have head and neck cancer treated with proton therapy at MDACC from January 1, 2008 through April 30, 2012 and patients who receive treatment from May 1, 2012 through December 31, 2018
Serum and Urine Ghrelin in Adult Epileptic Patients

Several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. There is a potential relation between its level and antiepileptic drugs (AED) response.

Several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. There is a potential relation between its level and antiepileptic drugs (AED) response. Objective: to evaluate ghrelin effect in adult epileptic patients and in response to AED. Methods: This case control study included 40 adult epileptic patients and 40 healthy controls. Participants were subjected to history taking of seizure semiology, full general and neurological examination, electroencephalography and cranial CT or MRI. Fasting serum acylated ghrelin (AG) and unacylated ghrelin (UAG) and urine AG levels were estimated to all participants by enzyme - linked immunosorbent assay (ELIZA).

Eligibility Criteria:
Inclusion Criteria:

* All participants were included if their age more than or equal to 18 years. Body mass index \< 30 kg/m2, total cholesterol \< 200mg/dl, serum triglycerides \< 200 mg/dl and random blood glucose level \< 126 mg/dl.

Exclusion Criteria:

* Participants had acute or chronic metabolic disorders (liver, kidney, thyroid, endocrine or gastrointestinal disorders).
* Females with irregular menstrual cycle or on estrogen therapy (7).
* Participants with organic cerebral lesion that was detected on cranial computed tomography (CT) or cranial magnetic resonance imaging (MRI).
Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis

The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional treatment can have adverse effects and does not guarantee effectiveness in some patients requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a beneficial effect in different disease, and have an anti-inflammatory effect in UC patients. Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a period of three months, in the degree of inflammation in patients with mild UC based on Mayo scale and quantification of IL-6 in the colonic mucosa.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis by histopathology of Ulcerative Colitis with mild activity level clinical, Endoscopic and histological.
* Extent of disease: pancolitis, ulcerative proctitis and left.
* Being treated with 5 - aminosalicylates (5-ASA).
* Belonging to the National Institute of Medical Sciences and Nutrition "Salvador Zubirán".
* Signed informed consent.

Exclusion Criteria:

* Autoimmune diseases (lupus, HIV, cancer and any hepatitis).
* Another type of colitis (indeterminate, infectious drug and Crohn's Disease.
* Previous total colectomy.
* Body mass index less than 19.9 kg/m2 or greater than 40 kg/m2.
* Patients in remission histology, clinical and endoscopic.
* Under treatment with steroids, azathioprine, diuretics and anticoagulants.
* Use Aloe Vera or some natural therapy.
Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

This is a one-arm, fixed-sequence study to compare the pharmacokinetic profiles of SHR6390 in absence and presence of prior administration of proton pump inhibitor Omeprazole. The increased gastric pH achieved by the treatment with multiple doses of Omeprazole might affect the absorption process of SHR6390.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Subjects shall ake effective contraceptive measures voluntarily within 7 months from the date of signing the informed consent form to the date of the last medication. Serum HCG test of fertile women before the study must be negative;
5. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
6. Healthy subjects identified by a detailed medical history;
7. Full physical examinations, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory test, are normal or abnormal but have no clinical significance.

Exclusion Criteria:

1. Blood donation or loss≥400 mL within 3 months prior to screening, or blood donation or loss≥200 mL, or blood transfusion within 1 months before screening;
2. Participating in any clinical trial or taking drugs that might damage organs within 3 months before screening;
3. Surgeries in the previous 6 months before screening;
4. Use of vaccines or biologicals within 2 weeks prior to screening;
5. Allergic constitution;
6. History of drug abuse or alcoholism, or positive for nicotine, alcohol and drug tests;
7. History of myocarditis, coronary heart disease, arrhythmia, stroke and so on, or 12 lead ECG demonstrating a corrected QT by Fridericia (QTcF) interval ≥450 msec;
8. With dysphagia or history of gut disease or surgery (gastrectomy, enterectomy, sleeve gastrectomy, etc) possibly affecting drug absorption;
9. Uncontrolled gut disease, such as peptic ulcer, colitis, pancreatitis, etc;
10. History of chronic kidney disease, renal insufficiency, anemia of renal failure, or creatinine clearance rate (CLCr) \< 80 mL/min, or serum creatinine ≥ ULN.
A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects

The purpose of this study is to examine the safety, tolerability, and PK of various increasing single and multiple doses of VBP15 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
* For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

* For the MAD Study: Women of childbearing potential.
* Clinically significant abnormal laboratory parameters