cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Trial of Biofeedback Therapy for Dyssynergic Defecation

Constipation is a common disorder and current treatments are unsatisfactory. Biofeedback may help patients with constipation and dyssynergic defecation, but its efficacy is unproven and whether this is due to behavioral modification or excessive attention is unknown. Methods: In a prospective randomized trial, the investigators investigated the efficacy of Biofeedback (manometric- assisted anal relaxation, muscle coordination and simulated defecation training), with either sham feedback therapy (Sham) or standard therapy (diet, exercise, laxatives; Standard) in 77 subjects (69 women) with dyssynergic defecation. Primary outcome measures included presence of dyssynergia, balloon expulsion time, number of complete spontaneous bowel movements (CSBM), and global bowel satisfaction. Data analyzed per protocol.


Eligibility Criteria:
Inclusion Criteria:Patients were included if they fulfilled Rome II criteria for functional constipation, and during attempted defecation demonstrated a dyssynergic pattern of defecation, and either had prolonged difficulty with expelling a simulated stool (\> 1 minute) or prolonged delay (\> 20% marker retention) in colonic transit.

Exclusion Criteria: They were required to have no evidence of structural or metabolic diseases that could cause constipation, as assessed by colonoscopy/barium enema and routine hematological, biochemical and thyroid function tests. Patients taking drugs known to be constipating, for example opioids were either excluded or were asked to discontinue the drug prior to enrollment. Other exclusion criteria included: severe cardiac or renal disease, previous gastrointestinal, spinal or pelvic surgery except cholecystectomy, hysterectomy or appendectomy, neurologic diseases such as multiple sclerosis, stroke or spinal injury, impaired cognizance (mini-mental score \< 15), legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating constipation and diarrhea.
Comparing OTC Acne Treatment to Prescription Regimen

This research is being done to find out the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne.

There are many products on the market to treat facial acne. The medication that this study will be evaluating, Benzaclin and Retin-A have been approved by the FDA and is available by prescription, Effaclar is an over the counter product. This study will hopefully recognize a treatment combination that is effective in reducing acne vulgaris in adults 18-50.

Eligibility Criteria:
Inclusion Criteria:males and females ages 18-50, mild to moderate acne vulgaris with \> or equal to 15 inflammatory lesions, \> or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study

Exclusion Criteria:Participants who have another skin condition that will interfere with lesion counting or assessments
SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF

Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. While hysteroscopy is regarded as the gold standard for diagnosis of intra-uterine pathology, it is not often used as an initial screening tool because of provider concerns about in-office tolerability, operating room costs, and use of anesthesia. The investigators aim to compare SIS and office hysteroscopy with respect to patient and provider satisfaction. Additionally, the investigators aim to assess the capability of office-based hysteroscopy to manage intra-uterine pathology at the time of diagnosis and reduce delays and supernumerary procedures.

Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. SIS is often performed as a screening tool in the office for uterine evaluation since it is straight-forward to perform, well-tolerated has low overhead cost. If uterine pathology is suspected on SIS, subsequent hysteroscopy is typically performed in the operating room. Hysteroscopy remains the gold standard for diagnosis of intra-uterine pathology and offers the opportunity for intervention at time of diagnosis, but often is not used as the initial screening tool because of provider concerns about in-office tolerability, equipment cost and maintenance. Technology advancements, however, has introduced an affordable, disposable, small caliber hysteroscopes with an operative channel to make it possible for this type of assessment to be performed in the office setting with the addition of a 'see and treat' modality. If used to perform initial uterine cavity evaluation, hysteroscopy may offer expedited diagnosis, treatment, and avoidance of general anesthesia. If superior specificity is demonstrated, it may also lower the false positive rate, preventing unnecessary delays to a patient's projected treatment plan, and unnecessary exposure to anesthesia risks. To date, no randomized control trials have compared the satisfaction of patients and providers to saline infusion sonography versus office hysteroscopy without anesthesia in initial cavity evaluation with the ability to immediately address intra-uterine pathology.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 - 50
* Patients undergoing routine cavity evaluation for planned in vitro-fertilization cycles

Exclusion Criteria:

* Clinical or radiologic suspicion of intrauterine pathology including myomas, severe intrauterine adhesions or retained products of conception
* Those with medical criteria not suitable office hysteroscopy due to requirement of advanced tools or preparation not available in the office such as history of bleeding disorder or medical co-morbidity
Infra Red Vein Visualization: Efficacy vs. Standard Technique

The objective of the study is to assess the efficacy of the vein visualization device AccuVein (AccuVein, Inc., Huntington, NY) in comparison to a standard technique for establishing intravenous (iv) access in the infant and toddler population (\<2years)

The objective of this project is to compare the iv success rate using the FDA approved Accuvein device for vein illumination versus not using the device, for infants/toddlers undergoing surgery at Penn State Children's Hospital with an ASA physical status 1, 2, or 3. After obtaining informed consent, the infant will be randomized to the vein illuminatin or standard group based on a computer generated number.

Eligibility Criteria:
Inclusion Criteria:

1. Children(\<2year) undergoing anesthesia procedures at Penn State Health, Hershey Medical Center and Penn State Children's Hospital
2. ASA physical status 1,2 or 3

Exclusion Criteria:

1. Emergency procedures requiring anesthesia
2. ASA physical status 4
3. Patients with pre existing iv access
Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts

This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) procedures.

Mucinous pancreatic cysts are considered pre-cancerous. The standard evaluation of pancreatic cysts usually includes endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). The cyst fluid sample from EUS-FNA is routinely sent for lab analysis (carcinoembryonic antigen-CEA) and cytology assessment. The diagnosis of a mucinous cyst is usually based on those results.

For study participants undergoing EUS-FNA, a small portion of the cyst fluid will be analyzed for glucose levels using a bedside glucometer in addition to the routine analyses. A low cyst fluid glucose level may correlate with a diagnosis of a mucinous cyst. The primary aim of this study will be to determine if a low cyst fluid glucose level correlates with standard laboratory cyst fluid analysis (CEA) in establishing a diagnosis of a mucinous pancreatic cyst.

Secondary aims of this study will be: (1) comparing the accuracy of cyst fluid glucose to CEA level among subjects with a proven diagnosis of a mucinous cyst (based on surgery or cytopathology findings), and (2) determining the optimal cyst fluid glucose level that correlates to a proven diagnosis of a mucinous cyst (based on subjects who undergo surgery or have a diagnosis based on cytopathology).

Eligibility Criteria:
Inclusion Criteria:

* All adults undergoing standard-of-care EUS-FNA procedures for the evaluation of pancreatic cysts are eligible to participate
* Minimum of 1mL of cyst fluid must be aspirated in order to be enrolled in the study

Exclusion Criteria:

* Inability to perform pancreatic cyst fluid sampling
* \<1mL of cyst fluid is aspirated during EUS-FNA
A Study of QLS31905 in Patients With Advanced Solid Tumors

This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. ≥18 years.
3. Female or male.
4. ECOG performance status score 0 or 1.
5. Histologically or cytologically confirmed diagnosis of advanced solid tumors.
6. Adequate haematological, hepatic and renal function.

Exclusion Criteria:

1. Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment.
2. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
3. Patients with a history of monoclonal antibody allergic reaction.
4. Known human immunodeficiency virus infection or known symptomatic hepatitis.
Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

The purpose of this study is to assess the adherence to an enhanced recovery after surgery (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in patients undergoing pancreaticoduodenectomy (PD).

A specific enhanced recovery after surgery (ERAS) protocol has been applied since October 2010 in consecutive patients undergoing pancreaticoduodenectomy (PD) in a high volume Institution. Patient compliance for each item has been assessed. Each ERAS patient was matched with a patient who received standard perioperative care. Match criteria were age, gender, malignant / benign disease, and PD prognostic score.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective pancreaticoduodenectomy

Exclusion Criteria:

* Intraoperative detection of metastatic disease (non-operability)
Children With Diabetes at Risk for Heart Disease.

Patients with type 1 diabetes type 1 (DM1) have increased risk of death due to heart disease and stroke. These cardiovascular conditions (CVD) are the leading cause of death in patients with DM1 younger than 40 years of age and up to 35% of all persons with DM1 will die before age 55 from CVD. Strategies are needed to help identify adolescents with DM1 at risk for CVD so that interventions to prevent heart disease and stroke can be undertaken.

Patients with type 1 diabetes and healthy controls will have evaluation of their lipid profile. Arterial stiffness, heart rate variability and adiposity measurements will be done in patients with type 1 diabetes and healthy controls. Blood pressure and heart rate will be recorded. 50 ml of urine will be collected from patients and controls.

All studies will be performed as a single outpatient visit at Georgetown University.

Eligibility Criteria:
Inclusion Criteria:

Diabetes type 1 or Healthy

Exclusion Criteria:

Taking medications that lower cholesterol Duration of type 1 diabetes \< 1 year.
'Wristband Device for the Measurement of Intermittent Blood Pressure and Other Physiological Signals

A wristband device intended for use as a standalone device, designed for the measurement of intermittent blood pressure, as well as other physiological signals. The device is intended to be worn in day to day life by individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.

The device is intended to be worn on the wrist for intermittent measurements of vital signs such as HR, blood pressure, Skin temperature and activity.

The use does not require any special action from the user apart form wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The waistband is watertight and can be worn as any type of bracelet all the time of most of the time.

The study will focus on patients in intensive care or any other cardiology unit who are under continuous oversight of existing Invasive (A-line Gold Standard monitors

Eligibility Criteria:
Inclusion Criteria:

1. Signed written Institution approved Informed Consent Form (ICF)
2. Male and Females over the age of 18 years
3. Patients in intensive care or cardiology units who are under continuous oversight of existing Invasive (A-Line) Gold Standard monitors.
4. Only subjects who are fitted with an invasive Arterial Line (A LINE)
5. To the extent possible, individuals who have not been using medication 5 (five) hours prior to the test shall be classified as non-medicated subjects.

Exclusion Criteria:

1. Subject who are unable to provide consent
2. Where it would be impractical or inconvenient or otherwise unfeasible to place to place a wristband and generate a signal.
3. Subjects who are not fitted with, or not planned to be fitted with an A-Line during their stay in the hospital.
Synchronous Video (Telemedicine) Consulation in the Prehospital Setting

The study team aims to test connectivity metrics and follow patient outcomes using a new, innovative synchronous video technology in the prehospital setting in three distinct areas:

1. - 911 Calls
2. - Pediatric Critical Care Transport

Currently, paramedics and pediatric transport teams seek advice from physicians using a telephone. This project replaces the phone with video consultation where the physicians can directly interact with patients, paramedics and transport teams when care advice is needed.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac Arrest
* Hemodynamically unstable trauma patients requiring resuscitation and airway management
* Trauma patients with altered mentation requiring airway management
* Acute stroke patients
* Medical patients that refuse transport for medical evaluation Pediatric Intensive Care Telemedicine Program
* Complex clinical situations where paramedic teams need immediate management guidance
* Critically ill pediatric patients requiring evaluation/stabilization for interfacility transport
* Pediatric patients requiring intervention for respiratory failure
* Pediatric patients with ongoing seizures and/or neurological abnormalities
* Hemodynamically unstable patients
* Complex clinical situations requiring medical control guidance

Exclusion Criteria:

• All other patients not list above
Anti-Reflux Mucosal Ablation(ARMA) and Anti-Reflux Mucosectomy(ARMS) in Gastroesophageal Reflux Disease

According to the current published data and treatment mechanism, ARMS may led to more stenosis while ARMA may be less effective in long term follow-up. The changes of patient's life quality , UGI tract microbiota before and after different endoscopic treatment are also limited. So we want to conduct a exploratory prospective randomized controlled study in evaluating the mucosal healing, demand of PPI, life quality, emotion status, sleep quality, esophageal motility/ acid exposure and saliva microbiota between chronic GERD patients receiving ARMS and ARMA treatment.

In this study, we will enroll 150 patients with chronic GERD. Estimated 40% of patients will be excluded from the inclusion and exclusion criteria. Of 90 patients eligible for the study, estimating 20% may drop out before receiving ARMS or ARMA. Estimated 72 patients will be randomized to receive ARMS or ARMA for GERD treatment. After ARMA, all patients will receive 4 weeks of PPI treatment. Endoscopy and questionnaire follow-up will be performed on week 2, 2 months, 6 months and 12 months after treatment while HRM and 24 hours pH impedance study will be performed 6 months after treatment.

The study will be carried out in 4 years. In the 1st to 3rd year of study, estimating 60,60,30 patients will be evaluated and entered the study in the 1st, 2nd and fisr half of 3rd year. Then all the patients will be followed until the first half of 4th year. At the second half of the 4th year, the saliva sample will be processed, data will be analyzed, and the result will be written.

1. st year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up
2. nd year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up
3. rd year study:30 patients enrollment, evluation and receiving endoscopy treatment with follow-up
4. th year study: complete all patients follow-up, sample processing, data analysis and report writing

Eligibility Criteria:
Inclusion Criteria:

* 20-75 years of age,
* History of GERD over 1 year

Exclusion Criteria:

* body mass index (BMI) \> 35
* Hiatal hernia \> 2cm
* Esophageal ulcer
* Esophageal stricture
* Barrett's esophagus (Prague criteria: C\>1cm, M\>=2cm)
* Major esophageal motility disorders
* Gastroparesis
* Pregnancy or plans for pregnancy in the next 12 months
* Immunosuppressive therapy
* Cirrhosis
* Portal hypertension and/or varices
* Previous gastric or esophageal surgery
* Esophageal diverticulum
* Scleroderma or dermatomyositis
* Coagulation disorders
* Anti-platelet or anticoagulants use
Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo

Vitiligo is a common acquired, depigmenting skin disease that affect the patient's psychological state and quality of life.

Vitiligo is a common acquired, depigmenting skin disease that affect the patient's psychological state and quality of life.

Regarding treatment of vitiligo, several modalities are available but none are completely satisfactory. Recently, fractional carbon dioxide (CO2) laser has been introduced as an add-on treatment for vitiligo.

Fractional CO2 laser acts by stimulating the release of cytokines and growth factors that act as mitogens for melanogenesis. Also, microscopic ablative zones produced by it promote the trans-epidermal penetration of topical agents, providing additional benefits for re-pigmentation.

Recently topical methotrexate 1% gel was used in a case report of vitiligo and was applied to a single patch twice daily for 12 weeks with significant improvement in pigmentation without local or systemic side effects during the course of therapy. Thus, it may prove to be an important steroid sparing agent in treatment of vitiligo.

As methotrexate is a large, hydrophilic molecule that does not penetrate intact skin, several drug delivery systems are being developed e.g. nano-vehicle preparations and laser-assisted delivery. One study has evaluated fractional Erbium laser-assisted delivery of topical methotrexate in porcine skin and found that methotrexate distribution and concentration in the mid-dermis was facilitated by ablative fractional laser, suggesting that ablative fractional laser-assisted topical methotrexate-delivery may be an appropriate alternative to systemic methotrexate for some skin disorders.

Ablative fractional laser-assisted delivery of topical 5-fluorouracil has been used in vitiligo in several studies with good results.

Serum interleukin-23 levels were significantly higher in vitiligo patients as compared with controls.

Eligibility Criteria:
Inclusion Criteria:

The patients will be enrolled in the study if they have:

* Non-segmental vitiligo
* Stable disease (a patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the past 1 year)

Exclusion Criteria:

1. History of skin cancers, keloid, hypertrophic scars or photosensitivity.
2. Use of any topical medications, phototherapy, or laser for vitiligo within 1 month prior to enrollment.
3. Renal, hepatic, hematological or debilitating chronic diseases.
4. Active inflammation or infection at site of treatment.
5. Pregnant and lactating females.
6. Age under 18 years old.
7. Segmental vitiligo, active or extensive disease.
8. Unrealistic expectation.
Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

Patients with cancer who develop stroke are at high risk for future strokes or other clotting events. These patients are routinely treated with medicines that thin their blood, including enoxaparin or aspirin. However, it is unclear which medicine is best and whether these medicines can be adequately studied in a clinical trial.

The purpose of this Phase I/II study is to determine if a clinical trial of different blood thinners in patients with cancer and stroke is possible. In addition, the study aims to compare the effects, good and/or bad, of enoxaparin with those of aspirin on patients with cancer and recent stroke.


Eligibility Criteria:
Any adult patient with active systemic cancer diagnosed with acute ischemic stroke at the main MSKCC campus or at any of MSKCC's New York City outpatient center WCMC, NYPH/CUMC within the prior four weeks would be eligible.

Inclusion Criteria:

* 18 to 85 years of age.
* Active cancer, defined as a pathologic diagnosis of or treatment for any cancer, other than basal-cell or squamous-cell carcinoma of the skin, within the past six months; or patients with known recurrent or metastatic disease within the past six months.
* A pathology report issued at the enrolling site confirming the diagnosis of cancer is required for enrollment.
* Acute ischemic stroke within the prior four weeks, defined as a new neurologic deficit(s) with MRI evidence of acute ischemia in a referable location, and no clinical or radiologic indication of a non-cerebrovascular mimic, such as a brain metastasis, as the etiology of the deficit(s).

Exclusion Criteria:

* Inability to get brain MRI
* Known malignant primary brain tumor.
* Diagnosis of intracranial hemorrhage within the past 3 months, including intratumoral hemorrhage into brain metastases from a systemic cancer.
* Active or serious bleeding within two weeks of enrollment.
* Patient condition associated with a high risk of bleeding such as recent surgery or peptic ulcer disease.
* Clear indication for anticoagulation (e.g., atrial fibrillation) anticipated during the study period.
* Clear indication for antiplatelet agents (e.g., cardiac stents); a patient receiving aspirin for primary prevention prior to index stroke may be enrolled as long as study investigators believe it would be safe for the patient to stop aspirin if the patient was randomized to the enoxaparin arm.
* Active bleeding diathesis.
* Platelet count of ≤ 70,000/mm3, an international normalized ratio (INR) \> 1.6, or a partial thromboplastin time (PTT) \> 40 seconds.
* Known allergy to heparin or aspirin or a history of heparin induced thrombocytopenia.
* Serum creatinine \> 2 mg/dl.
* AST or ALT \> 200 U/L.
* Hemoglobin \< 8 gm/dl
* Symptomatic carotid stenosis.
* Active pregnancy.
* Life expectancy \< 1 month or current hospice care
* Unavailability for follow-up.
Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoperative Diagnosis of Renal Oncocytoma

The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT imaging for the diagnosis of renal oncocytomas.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a solid enhancing cT1 renal mass detected on cross-sectional imaging
* Scheduled to undergo surgery with either partial or radical nephrectomy
* Age ≥18 years

Exclusion Criteria:

* Pregnancy
* Evidence of nodal or distant metastases
* History of other malignancy with concern for renal metastasis
* Known allergy to technetium or sestamibi