cyrilzakka/clinical-trials huggingface dataset:
Outpatient Foley For Starting Induction of Labor at TErm

The investigators are performing a randomized controlled-trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. This is a pilot study to establish the efficacy of this method in decreasing time as in inpatient and evaluate patient satisfaction.

Induction of labor is necessary in one-fourth of women and a large proportion requires cervical ripening. Cervical ripening is necessary to shorten the time to delivery and increases the chances of a vaginal delivery.

Outpatient cervical ripening is an attractive alternative to women and physicians because of the decreased amount of time spent in the hospital and opportunity for patients to be in the comforts of their home.

The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Multiparous
* Singleton gestation
* Gestational age between 39+0 and 42+0
* Vertex presentation
* Cervix ≤ 3 cm. If cervix is between 2 and 3 cm dilated, it must be \<80% effaced
* No prior cesarean section or uterine surgery
* Resides within Jefferson County, Alabama.
* Access to a telephone
* Reliable transportation

Exclusion Criteria:

* Unsuitable for outpatient Foley placement management (IUGR, oligohydramnios, prior cesarean delivery, gestational hypertension, preeclampsia, or uncontrolled chronic hypertension, complex maternal disease, provider discretion). Any patient with pregestational or gestational diabetes on medications will be excluded.
* Latex allergy
* Contraindication to induction of labor
* Evidence of labor
* Fetal anomaly or demise
* Inability to given consent (non-English speaking, inability to read or write)
Nadolol for Proliferating Infantile Hemangiomas

The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of infancy.

The secondary objective is to assess the feasibility of conducting a randomized controlled trial comparing nadolol with corticosteroids and propranolol.

Systemic corticosteroids are currently the most frequent used medication for treatment of problematic infantile hemangiomas (IH's). Since June 2008, systemic propranolol has been an important addition to the therapeutic options for problematic IH, allowing decreased dependence on the systemic corticosteroids. So far, we have found excellent response with propranolol with minimal short-term side effects. Studies, which compared nadolol and propranolol in children with other conditions, suggest that nadolol is safer and more efficacious than propranolol. In addition, it has better dosing schedules and less central nervous system (CNS) penetration, making it suitable even for patients with suspected or proven PHACES syndrome.

Eligibility Criteria:
Inclusion Criteria:

Intervention Group

* Infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement.

Historical Control Group

* Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years

Angiogenesis Marker Control Group

* Infants aged 1 month to 1 year attending dermatology clinic

Exclusion Criteria:

Intervention Group

* Patients with PHACES syndrome (proven) or suspected PHACES (plaque like hemangioma awaiting imaging).
* Children with history of hypersensitivity to beta blockers
* Children with personal history or family history of a first degree relative with asthma
* Children with known renal impairment
* Children with known cardiac conditions which may predispose to heart blocks
* Personal history of hypoglycemia
* Children on medications that may interact with beta blockers

Historical Control Group:

* No digital photography available documenting IHs progression

Angiogenesis Marker Control Group:

* Children with IH
* Children on beta blocker or systemic corticosteroids
Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

Fecal incontinence is common in patients with rectal cancer after surgery. Previous studies showed that pelvic floor muscle and external sphincter muscle training after stoma closure could improve the severity of incontinence and other fecal symptoms, but there is no study about the effects of pelvic floor muscle exercise intervention before stoma closure. We are wondering would the symptom of fecal incontinence recover sooner and better if we give the pelvic floor muscle exercise intervention before the stoma closure. This article aims at comparing the effects of pelvic floor muscle training before stoma closure on fecal incontinence (pre-intervention group) with pelvic floor muscle training after stoma closure (post-intervention group), and we hypothesise that the severity of fecal incontinence will improve sooner and better in pre-intervention group.


Eligibility Criteria:
Inclusion Criteria:

* rectal cancer patients who have received transanal total mesorectal excision(TaTME) surgery; 20\~75 years old

Exclusion Criteria:

* terminal stage of cancer; unable to following orders due to poor cognitive condition; too weak to follow the experimental procedures; central nervous system lesions
Procurement of Follicular B Cell Lymphoma Cells for the Purpose of Possible Use in Future Clinical Trials

In order to learn more about follicular lymphoma and anti-cancer vaccines, we are collecting samples from people with this diagnosis. We then hope to make a vaccine from this tissue to help the immune system destroy cancer cells. We plan on keeping samples in the tissue bank indefinitely.

- The following tests and procedures will be performed: Approximately 50cc of peripheral blood will be drawn and stored in the tissue bank; patients who have follicular lymphoma cells circulating in the blood will have about 40cc's of blood drawn and stored for processing; patients undergoing a lymph node biopsy will have samples of the biopsy stored; patients having fluid drained from the abdomen or from around the lung will have some of their fluid saved to cell collection and processing; patients undergoing a bone marrow biopsy will have some of the sample stored for cell collection and processing.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed, refractory or de novo histologically confirmed follicular B-cell lymphoma with accessible lymph nodes, tumor mass or malignant effusion or peripheral blood
* 35 years of age or older

Exclusion Criteria:

* Uncontrolled active infection
* HIV or viral Hepatitis infection
* Other current malignancies except any in situ cancer or basal or squamous cell carcinoma of the skin
* Autoimmune cytopenias
Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)

Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity.

IBS patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, will be included in the study consecutively. The patients will receive gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Effects of treatment will be measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.

Eligibility Criteria:
Inclusion Criteria:

* IBS diagnosis

Exclusion Criteria:

* Organic GI disease
A Study for the PanCystPro Assay in the Management of Pancreatic Cystic Lesions

The purpose of this research is to learn if the PanCystPro assay can help doctors in making decisions about treatment and monitoring of pancreatic cysts. The PanCystPro test measures glucose, carcinoembryonic antigen (CEA), and gastricsin biomarkers on fluid obtained from a pancreatic cyst. The test reports if the cyst fluid should be considered "Non-mucinous" or "Mucinous". Mucinous pancreatic cysts are more likely to progress to cancer while non-mucinous cysts seldom progress to cancer.

A prospective observational study to assess the impact of PanCystPro in patients with radiographically confirmed pancreatic cysts planned for Endoscopic Ultra Sound (EUS) Fine Needle Aspirate (FNA). Eligible subjects will be enrolled after signing the ICF. One pancreatic cyst sample will be sent to the Amplified lab for PanCystPro testing.

The impact of PanCystPro on clinical management intention will be assessed after the PanCystPro result has been received by the physician. One year after enrollment the actual clinical management the patient received will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Cross sectional imaging studies demonstrating a pancreatic cyst at least 12 mm in size where fluid sampling can aid in patient's management
* Written informed consent.
* The patient will be undergoing EUS with anticipated FNA extraction as part of standard patient care.

Exclusion Criteria:

* Patients diagnosed with pancreatic cancer.
* Pregnant or lactating females.
* Patients with contraindications to moderate or deep procedural sedation (necessary for the conduct of the endoscopic ultrasound) like major cardiorespiratory illness.
* Patients with contraindications to FNA of a pancreatic cyst like being on blood thinners.
Alcohol Pharmacotherapy for HIV+ Prisoners

This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.

INSPIRE is a randomized controlled trial of injectable intramuscular NTX (XR-NTX) versus intramuscular placebo among Human Immunodeficiency (HIV) infected prisoners meeting DSM-IV criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. While the COMBINE trial has demonstrated the effectiveness of oral naltrexone in a group of active alcohol dependent persons in decreasing relapse to alcohol use over placebo, naltrexone has not been studied in people who have a history of current alcohol dependence prior to incarceration, are incarcerated and not actively using alcohol and are likely to return to alcohol use when released. In this study, we conduct a placebo-controlled trial to determine if naltrexone has an effect in this group, which could be important in making the case for having naltrexone available to alcohol dependent or problem drinking HIV+ prisoners prior to release. We will compare their HIV treatment (HIV-1 RNA levels, CD4 count), alcohol treatment (time to relapse to heavy drinking, percent of days drinking, percent of days abstinent and alcohol craving) and HIV risk behavior (sexual and drug-related risks) outcomes. The hypotheses include:

i. XR-NTX will result in improved HIV clinical outcomes, including changes in HIV-1 RNA levels, and higher CD4 counts.

ii. XR-NTX will result in improved alcohol treatment outcomes, including longer time to alcohol relapse, lower percent days drinking, and lower craving for alcohol.

Eligibility Criteria:
Inclusion Criteria:

1. HIV+
2. Inmates returning to New Haven or Hartford
3. Meets criteria for alcohol dependence (using Diagnostic and Statistical Manual IV) or problem drinking (using Alcohol Use Disorder Identification Test-AUDIT)
4. Gives informed consent
5. English or Spanish speaker
6. \> 18 yrs

Exclusion Criteria:

1. On opiate pain medication or expressing need for them
2. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \> 5x the upper limit of normal
3. Evidence of Child's Pugh Class C cirrhosis
4. Pending felony charges
5. Pregnant or unwilling to take contraceptive measures
6. Subject is part of another pharmacological research study
A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)

The purpose of this randomized, multi-center,phase Ⅲ clinical trail is to compare the safety and efficacy of sequencial chemoradiotherapy with or without toripalimab (PD-1 antibody) for newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;
* newly diagnosed stage I/II patients;
* at least one evaluable lesion；
* ECOG PS 0-2;
* 18-75 years; without other malignancy;
* proper functioning of the major organs.

Exclusion Criteria:

* hemophagocytic syndrome or aggressive NK cell leukemia;
* involvement of central nervous system;
* previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant

The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.

After being informed about the study, all patients give writted informed consent. After that they will be randomized in two groups (A with drainage, B without drainage) using a random sequence generator. Then the patient will undergo the implantation of a three-component penile prosthesis following peri antibiotic prophylaxis with cephalosporins and aminoglycosides, the antibiotic prophylaxis will be continued on the first post-operative day surgery with a cephalosporin. In the group A it will be positioned at the scrotal level (using surgical access or using a second incision) an external drainage (10 Ch in aspiration) for 24 hours. The drainage will be removed on the first post-operative day. The degree of the hematoma will be determined using a 5-point Likert scales already approved in previous cases. Subsequently patients will carry out periodic check-ups at 7, 15 and 30 days after the operation to evaluate the appearance of hematomas and surgical site infection. After that, they will carry out check-ups every month for the first 3 months, then every 3 months for the first year and finally annually up to the fifth year after the intervention. During the clinical check-ups, it will also be defined the time of use of the penile prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed voluntarily according to the rules of good clinical practice (Declaration of Helsinki) and national regulations (Appendix B).
* Genetically male patient.
* Age ≥ 18 years.
* Patient suffering from ED of variable and/or multifactorial etiology.
* Patient suffering from ED not responsive to iPDE-5.
* Patient suffering from unresponsive or non-tolerant ED

Exclusion Criteria:

* Absence of signed written informed consent (Appendix B).
* Age \<18 years.
* Genetically female patients.
* Patient with active peno-scrotal infection.
* Patient with active systemic infection.
* Immunosuppressed patient.
* Patient with haematological pathologies that may cause an increased risk of bleeding.
* Patients suffering from Peyronie's Disease who must undergo simultaneous plaque surgery.
* Any condition or situation that, in the opinion of the investigator, places the patient at significant risk, may confound the results of the study, or significantly interfere with the patient's participation in the study.
* The patient declares that it will be impossible for him to participate in follow-up consultations.
Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis

The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting

The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in China. In the mean time ,more and more people accept revascularization. There are no prospective studies for comparison of prevention of restenosis after Drug -eluting stents and Bare-metal stents until now.

The main aim of this study is to observe the following details:

1. Late loss in lumen diameter in follow-up ≥50%
2. Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
3. Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs

Secondary endpoint:

brain, gastrointestinal and urinary system bleeding in 12 months follow-up

Eligibility Criteria:
Inclusion Criteria:

- symptomatic posterior circulation ischemia including monor stroke (mRS ≤2) or TIA result from the stenosis in the vertebral artery ostium.

70% to 99% stenosis of vertebral artery ostium.

Exclusion Criteria:

* etiology of stenotic lesions not atherosclerosis patients had undergone previos interventions on the vertebral artery ostium ipsilateral severe stenotic lesions in subclavian artery involved as well as vertebral artery ostium
The Study of Skeletal Muscle Function in Obstructive Sleep Apnea

The purposes of this study includes (1)to investigate inspiratory muscles and non-inspiratory muscle function in terms of strength, endurance, and fatigability in patients with obstructive sleep apnea (OSA), (2) investigate the metabolic characteristics of peripheral muscles and biochemistry markers in patients with OSA, and (3) to detect the effect of exercise training on the measured parameters in patients with OSA.

It has become increasingly recognized that skeletal muscle abnormalities are common and profound in patients with chronic inflammatory status. Based on the unique character of obstructive sleep apnea (OSA), repeated intermittent apnea and hypopnea caused by the upper airway muscles collapse during inspiration, it is logical to speculate some adaptations in skeletal muscle of patients with OSA. The purpose of the first part is to investigate the inspiratory muscle function in patients with different severity of OSA. Participants firstly underwent polysomnography assessments will be recruited. The measurements includes Epworth sleepiness scale, strength and endurance of inspiratory muscles, and fatigue test during either maximal voluntary efforts or in response to cervical magnetic stimulation (CMS) with simultaneously sEMG recordings. In addition, the exercise capacity with simultaneous sEMG recordings for diaphragm and vastus lateralis during the exercise testing will also be tested. The second part is designed to examine the metabolic characteristics of lower extremity in patients with OSA. Blood samples will be drawn and proton magnetic resonance spectroscopy is used to detect intramyocellular and extramyocellular lipid contents (IMCL and EMCL). The third part will detect the effect of exercise training on the measured parameters described as above in patients with OSA. Participants will be randomized into exercise group, inspiratory muscle training group (IMT), and CPAP group. Exercise protocol includes 30-minute aerobic exercise at the intensity of 70%-85% VO2max, and 20-minute general resistance exercise. IMT group will receive inspiratory muscle strengthening by device.

Eligibility Criteria:
Inclusion Criteria:

* ages from 40-65 years men who first underwent polysomnography at the Sleep Research Center.

Exclusion Criteria:

* Subjects who had active medical or nervous system diseases, abnormal pulmonary function, morbid obesity, diabetes managed with oral hypoglycemic agents, alcoholism (≥ 50 gm per day), or a recent infection.
Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons

Studies have confirmed the association between plantar callosities and severely obese individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for estimating body composition because it is easy to use, noninvasive, relatively inexpensive, and can be performed across a wide range of subjects.

Our hypotheses for this study are: (1)plantar callosities influence the body composition measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates the percentage of body fat compared with air-displacement plethysmography (BodPod).

As the prevalence of obesity continues to increase, many parts of the world are progressively facing a rise in the number of people who fall under WHO obesity class 2 and 3. Since severe obesity is characterized by large alterations in body compartments when compared to overweight or non-obese individuals, there is a need for the evaluation of the body composition of severely obese persons. There is very few published research available on what methods of body composition measurements can be used on this population.

Other studies have also shown the tendency of bioelectrical impedance analysis (BIA) instruments to underestimate percentage of fat mass and overestimate the percentage of fat free nass, compared with gold-standard techniques. We think that plantar callosities might have contributed to the lack of accurate measurements. Thus, the primary aim of this study is to determine whether plantar callosities influence the validity of body composition measurements obtained by BIA, using the InBody 720. The secondary aim is to assess the validity of the body composition measurements obtained by BIA (InBody 720) in severely obese individuals, using air-displacement plethysmography (BodPod) as the gold standard. Additionally, we will explore various sources of error using test-retest reliabilities by measuring body composition with different arm postures. We will examine this further to rule out the possibility of "positions of measurement" as a potential confounder of this study.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18-50 years old)
* class 2 and 3 obesity (BMI \> 35 kg/m2)
* moderate to severe callosities

Exclusion Criteria:

* Intractable plantar keratosis (IPK), which are painful plantar calluses located under the metatarsal heads.
* pregnancy
* menopause
* diseases that cause water retention (edema, renal insufficiency, hypertension, etc.)