cyrilzakka/clinical-trials huggingface dataset:
Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence

The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for Stress Urinary Incontinence (SUI). Safety information and patient outcomes will be collected for three (3) years and evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Female ≥ 18 years of age
2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study (subject or legal representative)
3. Diagnosed with predominant SUI confirmed by positive cough stress test during the protocol required bladder fill procedure (see manual of operations)
4. Confirmed SUI is greater than urge incontinence with the Medical Epidemiologic Social Aspect (MESA) questionnaire
5. Cystometric capacity ≥ 300 cc
6. Post-void residual (PVR) of ≤ 150 cc
7. Medically approved for general, regional or monitored anesthesia

Exclusion Criteria:

1. Subjects who are pregnant, lactating, or planning future pregnancies
2. Subjects with a chief complaint of overactive bladder
3. Subjects with a pattern of recurrent urinary tract infections, defined as ≥ 2 culture-proven urinary tract infections during a 6-month period prior to surgery or ≥ 3 in a 12-month period
4. Subjects with previous surgical procedures for SUI including bulking, urethral sling, bone anchor, Burch procedure, pubo-vaginal sling, and Marshall-Marchetti-Krantz (MMK) procedure. Excluding Kelly plication, Botox, anterior repair, or Inter-Stim
5. Subjects with prior pelvic organ prolapse surgery who experienced mesh complications
6. Subjects with previous radiation therapy to the pelvis
7. Subjects with known or suspected hypersensitivity to polypropylene mesh
8. Subjects with any of the following confounding conditions:

   1. Neurogenic bladder
   2. Urethral stricture and bladder neck contracture
   3. Bladder stones or tumors
   4. Urinary tract fistula or diverticula
   5. Pathology which would compromise implant placement including subjects currently taking anticoagulation therapy
   6. Pathology that would limit blood supply or infections that would compromise healing including chemotherapy, systemic steroids and systemic immunosuppressants
9. Subjects with diabetes and an A1c ≥ 7%
10. Non-English speaking subjects
11. Subjects who have participated in an investigational study (medical device or drug) within 30 days of study entry that may impact analysis of this device or have previously participated in the current study
Renal Venous Flow and Cardiac Surgery-associated Acute Kidney Injury

The prospective single-center study investigates the association between changes in Doppler-derived renal venous flow and cardiac surgery-associated acute kidney injury (CSA-AKI).

CSA-AKI is a common postoperative complication in patients undergoing open heart surgery, and is associated with increased mortality and morbidity. Venous congestion has been identified as the principal cause of cardiorenal decompensation in patients with heart failure but the relative contribution of congestion-driven renal function decline in CSA-AKI is not well studied.

The prospective single-center study investigates whether serial Doppler-derived renal venous flow assessments could help identify subset of patients with cardiorenal syndrome and subclinical renal congestion at high risk of CSA-AKI.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

1. Subjects older than 18 years
2. Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
3. Subjects who signed informed consent forms

Exclusion Criteria:

1. Patients requiring mechanical ventilation
2. Patients with mechanical circulatory assist devices or extracorporeal membrane oxygenation
3. Patients with stage 3 AKI with renal replacement therapy (RRT) or life- threatening volume overload treated with RRT
4. Stage ≥4 chronic kidney disease (CKD) stage
5. CKD requiring extracorporeal or peritoneal ultrafiltration for diuretic-resistant volume overload, 6) 6) Prediagnosed glomerulonephritis
6. Autosomal dominant polycystic kidney disease, postrenal obstruction, or solid organ transplantation
7. Anticipated life expectancy of \<12 months
8. Likelihood of receiving advanced therapy (mechanical circulatory assist device/cardiac transplant)
9. Pregnancy or possibility of pregnancy in the next 3 months
10. Rhabdomyolysis
Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans

The purpose of this study is to determine if bread containing fenugreek reduces blood sugar and insulin compared to identical bread without fenugreek.

Trigonella foenum-graecum (fenugreek) has been used in traditional medicine for the treatment of diabetes. Fenugreek has been demonstrated to lower blood glucose in response to a glucose load while leaving the levels of serum insulin unaffected in rodents. This effect of lowering blood sugar without changing insulin levels demonstrates improved insulin action. Fenugreek has also been shown to decrease glucose absorption by inhibiting intestinal disaccharidases. Fenugreek decreases glycohemoglobin in diabetic rodents. An amino acid extracted from fenugreek seeds, 4-hydroxyisoleucine, decreases glucose and insulin in diabetic rodents, improves glucose tolerance and stimulates insulin secretion from isolated pancreatic rodent islets.

Fenugreek imparts a bitter taste to products into which it is placed, and this property has limited its use in treating diabetes. Dr. Losso and his associates developed a process that allows incorporation of fenugreek into bread and other bakery goods without imparting a bitter taste, and the success of this process was confirmed in taste testing. This study is designed to evaluate the effect of fenugreek bread made by Dr. Losso's proprietary process on glucose and insulin.

Eligibility Criteria:
Inclusion criteria:

* Healthy male or female with diet controlled diabetes mellitus.
* Between 18 and 70 years of age.

Exclusion criteria:

* Pregnant or nursing.
* Taking medication for diabetes or a medication like oral cortisone that is known to affect blood sugar or blood insulin.
* Taking any chronic medication that has not had a stable dose for 1 month or longer. Oral contraceptives are accepted.
Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained before any trial related procedures
* Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
* ECOG score to be equal to or above 2
* Testosterone level within age-specific normal range
* PSA value equal to or above 2 ng/ml
* Life expectancy of at least 6 months

Exclusion Criteria:

* Previous or current hormonal treatment of prostate cancer
* Recent or current treatment with any drugs modifying the testosterone level
* Candidate for curative treatment such as prostatectomy or radiotherapy
* History of severe asthma, anaphylactic reactions or Quincke's Oedema
* Hypersensitivity towards any component of FE200486
* Cancer disease within the last ten years except for prostate cancer and some skin cancers
* Signs of liver impairment shown as elevated serum ALT or serum bilirubin
* Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
* Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
* Mental incapacity or language barrier
* Having received an investigational product within the last 12 weeks preceding the trial
* Previous participation in this trial
An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer

Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.

Those involved in the treatment of patients with breast cancer have pioneered the field of personalized cancer therapy through the use of targeted therapies and their associated biomarkers. Assays to quantify tumor acidosis and hypoxia are hypothesized to potentially represent such biomarkers. However there is currently no gold standard for measuring either.

This trial will evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe), to a clinical MRI scanner in women with early stage breast cancer. This trial will generate preliminary data regarding the feasibility of this imaging technique. If successful, in future studies CEST MRI may serve as an imaging biomarker for acidosis and hypoxia.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed infiltrating ductal carcinoma (IDC) of the breast
* \>= 1.0 cm primary tumor
* Calculated creatinine clearance \>= 50 mL/min
* Willing and able to provide informed consent
* Age ≥ 18 years
* ECOG performance status 0-2
* Informed of the investigational nature of this study

Exclusion Criteria:

* Allergy to iodinated contrast agent
* Use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of NSAIDs
* Diabetes mellitus
* History of severe claustrophobia
* Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI
* Use of \> 1 antihypertensive drug
* Pregnancy or breastfeeding
* Paraproteinemia syndromes or multiple myeloma
* Collagen vascular disease
* Active hyperthyroidism
* Active pharmaceutical treatments for cancer
The Lived Experiences Measured Using Rings Pilot Study

The transition to college is a period of elevated risk for a range of mental health conditions. For students with pre-existing mental health diagnoses, the added pressures can exacerbate challenges. Although colleges and universities strive to provide mental health support to their students, the high demand for these services makes it difficult to provide scalable cost-effective solutions. To address these issues, the present study aims to compare the efficacy of three different treatments using a large cohort of 600 students transitioning to college. Interventions were selected based on their potential for generalizability and cost-effectiveness on college campuses. The randomized controlled trial will assign 150 participants to one of four arms: 1) group-based therapy, 2) physical activity program, 3) nature experiences group, or 4) self-monitoring condition as the control group. In addition, biometric data will be collected from all participants using a wearable device to develop algorithmic predictions of mental and physical health functioning. Once recruitment is complete, modeling strategies will be used to evaluate the outcomes and effectiveness of each intervention. The findings of this study will provide evidence as to the benefits of implementing scalable and proactive interventions using technology with the goal of improving well-being and success of new college students.


Eligibility Criteria:
Inclusion Criteria:

* Current undergraduate student in their first year of school
* own a mobile device

Exclusion Criteria:

* None
Randomized Evaluation of Ten Allergy Skin Prick Test Devices

The goal of this study is to compare ten current and readily available FDA approved allergy skin prick devices to determine the most sensitive and specific product and methods used for the diagnosis of allergic disease. The primary outcome will be to determine the analytical sensitivity and specificity of all ten skin prick devices by measuring wheal and flare response to histamine and control diluent in 1mm increments. Secondary outcomes include comparison of skin prick technique, optimum histamine concentration, patient comfort, reproducibility, and the comparability of high-resolution digital images.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-65 with or without allergic disease

Exclusion Criteria:

* severe concurrent illness
* uncontrolled asthma
* extensive eczema
* urticaria
* dermatographism
* pregnancy
* those taking antihistamines within the previous 10 days
* topical steroids
* immunomodulatory drugs
* long term use of oral steroids
"Pi" and Hot Flushes

Hot flushes are common symptoms in women after menopause, and are important causes of discomfort and lead to high number of medical consultations. Hormone replacement therapy is an effective treatment, however it can bring undesirable consequences and may be contraindicated for some women. Options are inhibitors of serotonin or serotonin-norepinephrine reuptake, gabapentin, herbal medicines and homeopathy. None of these therapies is widely accepted of effective. Therefore, the search for new therapeutic options is highly desirable. Ingestion of malagueta pepper fruits (Capsicum frutescens L. var. malagueta) causes sensations similar to those experienced by menopausal women during hot flushes. By the principle of homeopathy, "the like cures the like", the objectives of this study are: (a) to determinate whether pathogenesis of a homeopathic medicine made from C. frutescens fruits include symptoms like hot flushes, and (b) whether this medicine is effective on hot flushes relief in women after menopause. There will be 2 distinct phases. Phase 1 is the determination of the medicine's pathogenesis in healthy volunteers, in a randomized placebo-controlled, double-blind design. Phase 2 is the investigation of the medicine's effects on hot flushes of women after menopause, in a randomized placebo-controlled, double-blind design. The investigators expect a significant reduction on symptoms perception, assessed by internationally validated tools. The study is expected to last for 18 months, with 36 patients included in each phase.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1: healthy volunteers
* Phase 2: menopaused women with hot flushes

Exclusion Criteria:

* Illiteracy;
* Have been enrolled in another clinical trial within the last 6 months;
* Use of pharmacological therapies for hot flushes;
* Have any degree of vulnerability;
* Allergy or hypersensitivity to Capsicum species;
Effects of Brief Training on Craving Regulation

The investigators propose that brief training in regulation of craving may increase the efficacy of smoking cessation, but that training in cognitive vs. mindfulness-based strategies may operate via different psychological and neural mechanisms.

The investigators propose to test the efficacy of such training by randomizing 126 cigarette smokers to the following conditions: 1) brief training in cognitive regulation of craving 2) mindfulness-based training, and 3) control or no training. Training will be delivered in 6x1 hour computerized sessions over four weeks. Control subjects simply fill out assessments during their visits. Participants who were randomized into the cognitive or mindfulness training complete Regulation of Craving (ROC) training sessions of approximately 60-90 minutes. If randomized into the cognitive regulation training, subjects will be trained to use a cognitive strategy that instructs them to think of all the negative outcomes associated with continued cigarette smoking. If randomized into the MBT-based regulation training, subjects will be trained to use a mindfulness strategy that instructs them to notice and accept their feelings of craving without judgment or intent to act upon them. After all training sessions are completed, there is a 4 week and 12 week follow-up. The investigators will evaluate the effects of training on craving and regulation of craving measured by self-report and functional magnetic resonance imaging during the Regulation of Craving(ROC) task administered pre- and post- treatment, as well as smoking.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 60
2. Smoking 10 or more cigarettes per day,
3. Score \>4 on the Fagerstrom Test For Nicotine Dependence (FTND)
4. Treatment seeking (motivated to quit or reduce smoking; \>6 on a 10 point likert scale)
5. Fluent English speaker
6. Can commit to the full length of the protocol (\~8 weeks) and
7. Are willing to be randomized to treatment condition.

Exclusion Criteria:

1. Current or past comorbid Axis I disorders (assessed via the Mini Psychiatric Interview Diagnosis; MINI)
2. Current use of any psychoactive medications that have not been at a stable dose for the past 6 months, are used as mood stabilizers, or are used as smoking cessation treatments (e.g. varenicline).
3. Serious or unstable medical condition within past 6 months
4. Use of an investigational drug currently or within past 30 days
5. Use of psychoactive medications or those that affect blood flow
6. Other conditions contra-indicated for MRI (e.g., claustrophobia, presence of ferromagnetic metal in the body, prior head trauma with loss of consciousness, color blindness, hypertension, pregnancy).
7. For females only: pregnancy.
The Efficacy and Safety of PEGylated GH for the Treatment of Short Stature in Chinese Children-GLOBE Reg

In order to further observe the long-term safety and effectiveness of real-world polyethylene glycol-recombinant human growth hormone(PEG-rhGH) treatment of GHD, idiopathic short stature, and SGA in children, explore and analyze the factors affecting the efficacy of PEG-rhGH and the height prediction model after treatment, etc., collect and analyze more scientifically and rationally, and understand the situation of real-world PEG-GH treatment. A database registration study was developed.

A database registration study was developed to retrospectively analyze the efficacy and safety of polyethylene glycol recombinant human growth hormone injection in the treatment of slow growth in children caused by endogenous growth hormone deficiency, idiopathic short stature, Turner syndrome, etc., and to further prospectively follow up and monitor. In order to participate in the global real-world use of long-acting growth hormone, all data from this study were uploaded to the Global Registry of New Therapies for Rare Endocrine Diseases and Bone Disorders (GloBE-Reg) platform.

Eligibility Criteria:
Inclusion Criteria:

Patients with endogenous growth hormone deficiency, Turner Syndrome, SGA, idiopathic short stature, etc. treated with polyethylene glycol recombinant human growth hormone injection

Exclusion Criteria:

Patients with serious heart and lung, blood system, malignant tumors and other diseases or systemic infections, immune function is low and Persons with mental illness;
Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass

RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has ovarian cancer.

PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass.

OBJECTIVES:

Primary

* Generate and validate a serum proteomic profile that can predict the presence of invasive ovarian epithelial cancer using preoperative serum specimens obtained from patients undergoing surgical evaluation for an abnormal pelvic mass.

Secondary

* Generate a proteomic profile that can distinguish early- from late-stage invasive ovarian epithelial cancer using preoperative serum specimens from patients who are subsequently diagnosed with invasive ovarian epithelial cancer.

Tertiary

* Determine whether serum proteomic profiling can predict the presence of postoperative residual disease in these patients.
* Determine whether serum proteomic profiling can predict prognosis in these patients.

OUTLINE: This is a pilot, two-part, multicenter study.

* Part A: Within 3 weeks prior to surgical evaluation, patients undergo collection of serum specimen for proteomic profiling using surface-enhanced or matrix-associated laser desorption ionization spectrometry-time of flight detection (SELDI/MALDI-TOF). Patients then undergo surgical evaluation (i.e., biopsy and/or resection) of the pelvic mass. Patients who are diagnosed with invasive ovarian epithelial adenocarcinoma or papillary serous fallopian tube carcinoma (no low malignant potential tumors) AND are without postoperative infection proceed to part B of the study.
* Part B: Patients undergo collection of postoperative serum specimen for proteomic profiling using SELDI/MALDI-TOF within 3-8 weeks after surgery, before starting chemotherapy, and at end of chemotherapy.

After completion of study procedures, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Abnormal pelvic mass by physical examination or imaging test

  * Undiagnosed
* Planning to undergo surgical evaluation within the next 3 weeks

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Surgery

* See Disease Characteristics