cyrilzakka/clinical-trials huggingface dataset:
MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer

The purpose of this study is to establish a prospective database of anal canal and perianal cancer patients treated with IMRT and chemotherapy with curative intent at PMH for the purposes of investigating MRI-derived primary tumor parameters. Patients who decide to participate in this study will be treated according to standard treatment policies and radiation therapy planning protocols at Princess Margaret Hospital (PMH) with radiation therapy +/- chemotherapy. IMRT for all treatment phases of radiotherapy has been implemented as standard treatment. Surgery is reserved for salvage treatment.

Anal cancer is an uncommon cancer, accounting for 2% of gastrointestinal cancers. Prognostic factors include tumor differentiation and staging, along with patient gender, race, and socioeconomic status. The standard of care is radical chemoradiation with 5-fluorouracil and mitomycin C, with surgery reserved for salvage. Intensity modulated radiation therapy (IMRT) is a specialized radiotherapy technique that may be used for anal cancer. IMRT allows the radiation dose to conform to the three-dimensional shape of the target volume more than conventional two-dimensional techniques, and it may reduce treatment toxicities without compromising tumor control. At the Princess Margaret Hospital (PMH) since July 2007, IMRT for all treatment phases of radiotherapy has been implemented as standard treatment for patients with anal canal and perianal cancer.

Eligibility Criteria:
Inclusion Criteria:

* histological confirmation of invasive primary squamous cell carcinoma or adenocarcinoma of the anal canal or perianal region
* treatment with curative intent
* patients who are not eligible for chemotherapy and receive IMRT alone are eligible for evaluation
* primary anal or perianal cancer evaluable on cross-sectional imaging (CT or MRI) scan
* ECOG performance status of 0, 1, or 2
* age \> 18 years
* able to provide informed consent

Exclusion Criteria:

* evidence of distant metastasis (M1)
* prior radiation therapy to the pelvis or contraindication to radiotherapy
* contraindication to MRI imaging
* known allergy to intravenous Gadolinium
* renal insufficiency (serum creatinine greater than 150)
* serious claustrophobia
* cardiac pacemaker
* hip prosthesis
* major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of imaging study
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
* At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
* Good general health
* Normal or clinically insignificant cervical smear
* An endometrial biopsy performed during the screening period, without significant histological disorder
* Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Hypersensitivity to any ingredient of the study drug
* Any condition requiring immediate blood transfusion
* Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Abuse of alcohol, drugs, or medicines (eg, laxatives)
* Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
* Undiagnosed abnormal genital bleeding
Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia

The objective of the INCORPORATE trial is to evaluate whether an intentional invasive strategy with ischemia targeted, reasonably complete coronary revascularization and optimal medical therapy is superior as compared to a primary conservative approach and optimal medical therapy alone in terms of spontaneous myocardial infarct-free and overall survival in patients with severe peripheral artery disease, underwent peripheral artery revascularization due to critical limb ischemia.

The INCORPORATE trial is designed to be non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients, undergoing successful peripheral revascularization (percutaneous or surgical) due to critical limb ischemia will be screened, and enrolled if informed consent form is signed and none of the following exclusion criteria is met.

Exclusion Criteria:

* contraindication for double antiplatelet therapy for at least one month;
* contraindication for guideline-conform longterm antiplatelet/anticoagulation regime after PCI;
* heart failure with ejection fraction below 35%;
* significant valvular heart disease with indication for surgical or percutaneous repair;
* any concomitant disease with a life expectancy less than 2 years;
* severe renal dysfunction with glomerular filtration rate below 30 mL/min/1.73m2;
* ongoing sepsis.

Patients, who cannot be enrolled for any reasons will enter a prospective registry.
A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese UC patients undergoing colectomy with eventual IPAA.


Eligibility Criteria:
Inclusion Criteria:

* BMI 30-50 kg/m2 for at least 6 months prior to ESG
* Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA)
* Willing to adhere to the diet and behavior modifications required for ESG
* Able to follow the visit schedule
* Able to provide informed consent
* If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline

Exclusion Criteria:

* Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG
* Current or recent (last six months) gastric or duodenal ulceration
* Esophageal or gastric varices
* Significant motility disorder of the esophagus or stomach
* Large hiatal hernia measuring \>5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux
* Severe coagulopathy, hepatic insufficiency, or cirrhosis
* Gastric mass
* Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and/or history of severe hepatic, cardiac, or pulmonary disease
* Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits
* Unwilling to participate in an established diet and behavior modification program, with routine follow-up
* Ongoing corticosteroid use at a dose of \>5 mg daily
* Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision
* Alcohol or drug addiction
* Females who are pregnant, nursing, or planning pregnancy within the next year
* Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations
* Has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study
Shape Up! Kids Study

Identify the unique associations of body shape to body composition and bone density indices in a pediatric population that represents the variance of sex, age, BMI-Z, and ethnicity found in the US population.

Describe the precision and accuracy of optical scans to monitor change in body composition, bone density and metabolic health interventions.

Estimate the level of association of optical to common health indicators including metabolic risk factors (glucose, triglycerides, HDL-cholesterol, blood pressure, VAT, WC and strength) by gender, race, age, and BMI-Z.

Investigate holistic, high-resolution descriptors of 3D body shape as direct predictors of body composition and metabolic risk using statistical shape models and Latent Class Analysis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants will be included in the study if they have a self-reported ability to:

  * walk one-quarter of a mile and climb 10 steps without difficulty,
  * perform activities of daily living (ADLs) without difficulty, and
  * have no life-threatening conditions or diseases that would alter body composition from what is typical for age, sex, ethnicity, and BMI.

Exclusion Criteria:

* any internal metal artifact (e.g. pacemakers, internal fixation, arthroplasty), amputation, physical impairment or previous fracture that would alter body composition assessment
* Pregnant or breastfeeding. (All premenopausal females will be asked for a spot urine sample for pregnancy test prior to participation. Those unwilling to comply with this will not be included.
Association Between Postoperative Administration of L-Arginine and CSA-AKI

To investigate the association between the the early administration of L-Arginine after CPB-assisted cardiac surgery and the incidence of CS-AKI in adult patients. To test if it can reduce the incidence of post-operative AKI.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (over 18 years)
* underwent CPB assisted cardiac surgery
* admitted to ICU

Exclusion Criteria:

* congenital heart disease
* underwent deep hypothermic circulatory arrest (DHCA)
* with glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia

This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).


Eligibility Criteria:
Inclusion Criteria:

* Chronic renal anemia;
* Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
* Hb concentration between 10 and 12 g/dL;
* Adequate iron status.

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months;
* Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
* Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
* Active malignant disease.
Vaginal Progesterone for the Prevention of Preterm Birth in Twins

This trial is a randomised, multi-centre, 2 x 2 factorial designed pilot trial with two factors of 200mg vs. 400mg progesterone self-administered daily from 11-14 weeks' gestation vs. 20-24 weeks' gestation, to compare the median gestational age (in days) at delivery between the comparison groups.

Randomised studies in singleton pregnancies suggest that the risk of preterm birth can be decreased by using of progesterone. However, in twin pregnancies, no significant reduction in preterm birth has been demonstrated in any trial.

One explanation for the lack of benefit of progesterone in previous twin studies may result from a suboptimal dosage. The investigators therefore hypothesize that progesterone dosages that are sufficient for singleton pregnancies are insufficient for twins and this is likely to be one of the reasons why prophylactic progesterone has failed to reduce preterm birth in twins.

Another possible explanation for the negative findings in previous twin studies may result from administration beginning too late in the second-trimester. It is thought that the mechanism of preterm birth in twin pregnancies is more strongly related to exaggerated uterine distension, which may override any benefit of progesterone on the cervix after a threshold has been reached. It is also plausible that cervical shortening occurs earlier in twin pregnancies than with singletons, and that treatment is required before a threshold of shortening is reached or before any inflammation-mediated component to the initiation of preterm birth has been established as the biological mechanisms by which preterm birth occurs differ from those in singleton pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Dichorionic diamniotic (DCDA) pregnancies
* Live fetuses at 11-13 weeks of gestation,
* Informed and written consent

Exclusion Criteria:

* High-risk for aneuploidies,
* Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks or 20-24 weeks assessment,
* Hypersensitivity to progesterone,
* Women taking progesterone regularly or at any time within the previous 7 days,
* Concurrent participation in another drug trial or at any time within the previous 28 days,
* Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness,
* Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma

The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.


Eligibility Criteria:
Inclusion Criteria:

-Participants and Target Disease Characteristics- -

* Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab
* Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be submitted for embedded tissue block or tumor tissue.

Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection.

WOCBP need to use contraception throughout the study and for 5 months post treatment.

Exclusion Criteria autoimmune disease statement

* Active central nervous system metastases
* Participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll.
* Any major surgery 28 days before 1st treatment Concomitant Therapy
* participants that have received a live vaccine within 30 days of treatment.
* use of investigational agent or device with in 28 days before first dosage study treatment.

Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and Reproduction
The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement

Total hip replacement is a major surgical procedure usually associated with significant pain in the early postoperative period. In our hospital, total hip replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus opioid in the form of preservative free morphine. The use of 'local infiltration analgesia' as an alternative postoperative analgesic technique has been investigated.In this technique the surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a catheter under direct vision which remains in situ and is used to administer local anaesthetic in the postoperative period until such time as it is removed (when no longer deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48 hours). We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for unilateral total hip replacement
* Consent to spinal anaesthesia
* ASA Grade I to III

Exclusion Criteria:

* Patient refusal
* Mini-Mental Score \< 25
* Allergy to bupivacaine, morphine, paracetamol, diclofenac
* Skin lesions/infection at site of injection
* Uncorrected renal dysfunction
* Coagulation disorders
* chronic pain condition other than hip pain
Penile Length Restoration in Men With Diabetes Mellitus, Type II

The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes.

Men with diabetes mellitus experience sexual dysfunctions at an earlier age and higher rate compared to men without diabetes. One of these sexual dysfunctions includes diminished penile length. It is currently unknown if the decreased length is due to earlier erectile dysfunction or secondary to diabetes itself. Penile traction therapy is one of several treatments which have been used historically to treat decreased penile length, however, to date, no studies have evaluated the role of traction therapy in men with diabetes. To accomplish the study, a population of men from Mayo Clinic with a diagnosis of diabetes, type II will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at the 3 and 6 month time points, and the results are to be used with the intent to publish in a scientific journal.

Eligibility Criteria:
Inclusion Criteria:

- Men with Diabetes Mellitus, Type II

Exclusion Criteria:

* Any evidence of end-organ failure attributed to DM (assessed based on medical history / patient history alone)
* Loss of fingers / toes.
* CKD Stage IV or greater.
* Retinopathy
* Myocardial infarction.
* Cerebrovascular accident.
* Indwelling penile prosthesis or prior history of penile prosthesis.
* Peyronie's disease at baseline.
Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

Mechanism-based acne treatment for transgender patients receiving testosterone currently does not exist and is an unmet medical need. This study explores clascoterone to treat testosterone induced acne. Many treatments we use to treat acne in females cannot be used in transgender males because they interfere with hormone therapy. Androgens have been associated with the development of acne vulgaris. Recently, a topical androgen receptor inhibitor cream (clascoterone) has been FDA-approved for the treatment of acne. However, clinical trials of clascoterone have excluded participants on exogenous hormones. Clascoterone has been hypothesized to be effective in the treatment of acne in transgender male participants on masculinizing hormone therapy, but it has never been studied or reported in the literature.


Eligibility Criteria:
Inclusion Criteria:

* transgender male or gender diverse patient on MHT
* on a stable dose of MHT for at least 3 months prior to the study
* anticipate being on the same dose of MHT for the duration of the study
* have steroid-related acne vulgaris as determined by the investigator with onset or worsening after initiation of MHT
* have at least 20 papules or pustules on the face
* consistent skin care regimen (topical and systemic medications) for at least 4 weeks prior to enrollment and continue it for the duration of the study (however, note exclusion below that topical steroids on face not allowed for 4 weeks prior to enrollment and during study)\*;
* age 16 years old or older
* potential participants who have ovaries and are or planning to be sexually active with partners that produce sperm will need to use a medically reliable form of birth control (including but not limited to condoms, intrauterine device, oral contraceptives) before enrollment and during the study

  * Note inhaled steroids are allowed as long as regimen is stable one month prior to enrollment and during the study

Exclusion Criteria:

* changes in topical or systemic anti-acne medications or procedures within four weeks of study enrollment
* use of topical steroids on the face within 4 weeks prior to enrollment and during study
* pregnant or breast-feeding patients
* unable to provide informed consent, follow the protocol, attend study visits, or any other circumstance or condition which the investigator deems may obscure interpretation of results or affect safety of the potential participant.
Endoscopic Gastric Reduction of Gastric Mucosa in Obesity

In the stomach, the ghrelin-containing cells are more abundant in the fundus than in the pylorus originally termed X/A-like cells. These X/A-like cells account for approximately 20 % of the endocrine cell population in adult oxyntic glands.

Ghrelin enhances the secretion of growth hormone, the stimulation of appetite and food intake, the modulation of gastric acid secretion \& motility and the endocrine and exocrine pancreatic secretions.

Ghrelin is 28 amino acid peptide hormone, approximately 70 % of circulating ghrelin is secreted by the stomach, with most of the remainder originating in duodenum, jejunum, and ileum. Lower amount of secretion outside the gut, including hypothalamus (arcuate nucleus and paraventricular nucleus), pituitary, lung, adrenal cortex, kidney, bone, testis, placenta and pancreatic islet cells Ghrelin enhances the secretion of growth hormone, the stimulation of appetite and food intake, the modulation of gastric acid secretion \& motility and the endocrine and exocrine pancreatic secretions. Synthetic ghrelin imitative was shown to increase fat deposition and appetite through an action at the level of the hypothalamus arcuate nucleus mainly the orexigenic neuropeptide Y (NPY) neurons.

Alterations of ghrelin play an important role in appetite fluctuation following meals. The secretion of ghrelin by the stomach depends largely on the nutritional state. Ghrelin levels show pre-prandial increases and postprandial decreases.

Low systemic ghrelin levels have been reported in untreated hyperthyroidism, in male hypogonadism, in the polycystic ovary syndrome, or after total gastrectomy \[5, 6\].

Eligibility Criteria:
Inclusion Criteria:

* body mass index more than 25
* diagnosis of diabetes mellitus.
* diagnosis of cardio-metabolic syndrome.
* fatty liver disease diagnosed by abdominal ultrasound.

Exclusion Criteria:

* use of drugs which induce insulin resistance, diabetes and hepatic steatosis.
* excess alcohol consumption.
* chronic gastritis, active peptic ulcer.
* malignancy.
* depression and severe psychological disorders
* inability to give informed consent.
* coagulopathy (INR more than 1.5, platelets less than 50000 per cmm).
* severe cardiopulmonary comorbidity.