cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment

The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Proven gastroesophageal reflux (pH \< 4 for \> 4.3% time while off PPIs for 7-14 days)
* On daily PPIs for \> 1 year
* Recurrence of GERD symptoms (GERD-HRQL score difference of \> 10 between on and off PPIs)
* Normal or hypotonic LES resting pressure (5-40 mmHg)
* Patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol
* Signed informed consent

Exclusion Criteria:

* BMI \> 35
* Hiatal hernia \> 2 cm
* Esophagitis grade D
* Barrett's esophagus
* Esophageal stricture
* Esophageal ulcer
* Esophageal motility disorder
* Gastric motility disorder
* Prior splenectomy
* Gastric paralysis
* Pregnancy (in females)
* Immunosuppression
* ASA \> 2
* Portal hypertension
* Coagulation disorders
* Previous antireflux procedure
* Any other health condition, which the investigator believes would prevent the patient from completing the study
* Lack of fluency in English
Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue

The purpose of this research is to examine the effect of a broccoli sprout preparation on specific factors in breast tissue that are related to breast cancer risk and to assess whether sulforaphane a key component of broccoli sprouts increases the levels of protective enzymes in breast tissue. In addition, the investigators will also examine how acceptable the broccoli sprouts preparation is to the study participants.

A double-blind randomized Phase II chemoprevention trial of BSE versus placebo will be conducted in up to 35 women diagnosed with DCIS on core biopsy prior to their definitive surgery (study diagram below). The primary study endpoint will be a decrease in the mean proliferative rate measured by Ki67%.

Women diagnosed with DCIS on core or incisional/excisional biopsy scheduled for definitive surgery at Johns Hopkins Hospital will be recruited for this study. Participants will be placed on a cruciferous free diet for the 14 days prior to their surgical date and drink a randomized intervention beverage (mango juice with or without broccoli sprout extract). Additionally participants will provide 2 blood and 2 urine sample collections, report medication use and adverse events using prepared forms and complete a daily diet check list during the 14 day intervention. On the day of definitive breast surgery, 1-2 grams of breast tissue (including normal adjacent breast tissue) will be collected during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female 18 + years of age
* Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery
* Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening
* Agree to avoid cruciferous vegetable/condiment intake for 14 days
* Agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes

Exclusion Criteria:

* Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ
* Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening
* Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)
* Smoked within the past 12 months prior to eligibility screening;
* Active infection or inflammation of the breast at time of eligibility screening
* Has baseline comprehensive metabolic panel (CMP) \[Glucose, Calcium, Albumin, Serum total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST), Aspartate amino transferase (SGOT), and Bilirubin\], prothrombin time (PT) and , complete blood count (CBC) values that are 1.5 times in either direction the reported normal range
A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.

Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.

Protocol Objectives include:

* Determine the proportion of patients with HCC in whom the treatment plan can be completed
* Evaluate the response to therapy
* Evaluate toxicities and adverse experiences associated with TheraSphere treatment
* Evaluate survival time

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age of any sex, race
* Histological proof of HCC
* Able to give Informed Consent
* ECOG performance equal or less than 2
* Life expectancy equal to or greater than 3 months
* Non- pregnant with acceptable contraception in premenopausal women
* Greater than 4 weeks since prior radiation therapy or surgery
* 1 month post chemotherapy
* Serum Bilirubin \< 2.0
* Acceptable white blood count

Exclusion Criteria:

* Co-morbid disease that would place patient at undue risk.
* Pre-existing diarrhea/illness
* Pregnant
* Fail preliminary MAA testing
Replication of the Heads Up Atopic Dermatitis Trial With Registry Data

The goal is the replication of the primary outcome (EASI 75 at week 16) of the Heads Up trial (Blauvelt, A, Teixeira, H, Simpson, E et al (2021) doi:10.1001/jamadermatol.2021.3023) and the evaluation of the patient reported outcomes (POEM, DLQI and RECAP) in a head-to-head comparison of upadacitinib versus dupilumab treatment in moderate-to-severe atopic dermatitis (AD).

Atopic dermatitis (AD) is an inflammatory, multifactorial skin disease characterized by eczematous skin lesions, severe itching, and negative consequences on quality of life. The goal of this study is the replication of the primary outcome (Eczema Area and Severity Index (EASI) 75 at week 16) of the Heads Up trial and the evaluation of the patient reported outcomes (Patient-oriented Eczema Measure (POEM), Dermatologic Quality of Life Index (DLQI) and Recap of Atopic Eczema (RECAP)) that were not assessed in the Heads Up trial but are part of the recommendations by the Harmonising Outcome Measures for Eczema (HOME) initiative (Williams, HC, Schmitt, J, Thomas, KS et al (2022) doi:10.1016\\j.jaci.2022.03.017) regarding core outcome sets in atopic dermatitis clinical trials. The core outcome set as defined by HOME encompasses the following domains (core outcome instruments): clinical signs (EASI), patient-reported symptoms (POEM and Peak Itch), long term control (RECAP) and quality of life (DLQI). The data basis is the TREATgermany registry (https://treatgermany.org/). TREATgermany is a national clinical registry for patients with moderate to severe AD. The physician and patient-reported outcomes are collected in about 60 clinics and private practices during routine care. Data of more than 2,400 patients is currently documented.

Eligibility Criteria:
Inclusion Criteria:

* Chronic AD with onset of symptoms at least 3 years prior to baseline
* Meets UK working party criteria
* EASI score ≥ 16
* ≥ 10% body surface area (BSA) of AD involvement at baseline ("therapy start") visit

Exclusion Criteria:

* contraindications according to upadacitinib or dupilumab labeling
Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia

This study will detect the effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia.

The current study will be directed to investigate effect of virtual reality on gross motor and balance as the weakness of the trunk muscles and lower limb muscles along with spasticity potentially predispose balance and walking issues of children with bilateral spastic CP .

The balance deficits in children with CP are multifactorial. According to the system's model proposed by Woollacott and Shumway-Cook, multiple systems contribute to postural dysfunction in children with CP. Muscle weakness and stiffness of lower limb muscles account for biomechanical constraints and postural malalignment during standing and functional balancing.

Virtual reality is one of the novel technology-based approaches to treat balance and motor function in children with CP. It utilizes the interactive simulations created in computer hardware and software, in which the children find opportunities to engage in environments appearing real to them .

After reviewing the available previous published studies, it was found that there is no previous study directly compared between the effects of virtual reality and physical therapy in spider cage on gross motor performance and balance with diplegic children CP children. Both therapeutic modalities were found to induce good clinical outcomes when studied separately, so this study will be conducted to examine the effectiveness of virtual reality.

The greater demand for physical therapy for Paediatrics' signifies the need for more effective, safer and evident therapeutic modalities. The findings of this study will help both; the therapists and the children to save time, effort and reach the best results in concise times.

Eligibility Criteria:
Inclusion Criteria:

* Children will be included in the study if they fulfil the following criteria:

  1. A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists.
  2. Children with spasticity grades ranged from 1 to 2+ according to Modified Ashworth scale (MAS).
  3. Their age range from 6 to 12 years.
  4. Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques.

Exclusion Criteria:

* Children with a permanent spastic diplegia, who might have one or more of the following, will be excluded:

  1. They had a permanent deformity (bony or soft tissue contractures).
  2. Children having visual or auditory defects.
  3. Current hospitalization for urgent medical reasons.
  4. Severe mental retardation.
  5. Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey.
  6. Children with history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.
Trial of Montelukast in Eosinophilic Esophagitis

Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE.

Also evaluate tolerance and safety of oral montelukast in treatment of EE.

We will randomize in a double blind manner 60 consecutive consenting patients being evaluated at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or placebo daily for six months? time. Patients will be in remission after treatment with topical fluticasone therapy before enrollment. Patients will fill out a validated dysphagia and side effect questionnaire before, during, and at the end of therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* \> 14 eosinophils / hpf on biopsies from mid esophagus within the 6 months.
* Abnormal dysphagia questionnaire (Question 1a yes, question 1c \>/= mild and question 2 \>/= less than once a week) prior to topical steroid treatment. This questionnaire has recently been validated.
* Normal dysphagia questionnaire after topical steroid treatment (Having an answer of no to question 1a: Have you had trouble swallowing, not associated with other cold symptoms? over the past two weeks since having completed the swallowed steroid treatment).
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules

The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* No allergies to indomethacin or related drugs
Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)

The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical outcomes.

Subscapularis management is an area of controversy in the literature for total shoulder arthroplasty (TSA). Regeneten has been suggested as a bioinductive implant to aid in rotator cuff healing. We hypothesize that applying this technology could aid in obtaining higher rates of subscapularis healing for TSA when utilizing SP or ST, which in turn could lead to improved outcomes.The 50 randomized subjects will be randomized at a 1:1 ratio into the standard subscapularis repair group or the standard repair with Regeneten augmentation group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent surgical procedure, the blinded assignment will be revealed to the subject. Subjects will be assessed pre-operatively and return post-operatively at Week 2, Weeks 6, Month 3, Month 6, and Year 1. The primary outcome will evaluate subscapularis repair integrity and healing at one year post-op.

Eligibility Criteria:
Inclusion Criteria:

1. Patients healthy enough to undergo primary anatomic TSA
2. Being treated with subscapularis tenotomy or subscapularis peel.
3. Age 50 or above
4. Intact rotator cuff including subscapularis as determined by preoperative examination and imaging (typically preoperative CT, MRI if indicated or available).

Exclusion Criteria:

1. Revision arthroplasty
2. Reverse arthroplasty
3. Requiring a lesser tuberosity osteotomy
4. Intraoperative identification of rotator cuff tear requiring repair
5. Object to using cow derived material
6. Prior index shoulder surgery requiring treatment to the subscapularis
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions

The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female patients 18 years of age
2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
3. Treatment of a single de novo target lesion in a major native coronary artery;
4. Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
5. Target lesion is 30mm in length (visual estimate);
6. Target lesion stenosis is \> 50% and \< 100% (visual estimate);

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \> 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
2. Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
3. Significant (\> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
4. Documented Left ventricular ejection fraction 25%;
5. Totally occluded vessel (TIMI 0 level);
6. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
FemPulse Therapy First-in-Human Experience

The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Eligibility Criteria:
Inclusion Criteria:

* Females ≥21 yrs with Overactive Bladder

Exclusion Criteria:

* Is or was recently pregnant
* Has a metal pelvic implant or any electrically active implanted medical device
* Has a urinary tract or vaginal infection
* Had a previous hysterectomy, pelvic radiation or pelvic cancer
* Has significant pelvic organ prolapse
* Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
* Has a significant heart condition or a history of vasovagal reaction or low blood pressure
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.

Preliminary data suggest intralesional rituximab is able to revert resistance to systemic rituximab in patients with CD20+ indolent lymphoma of the conjunctiva, and the addition of autologous serum seems to exhibit a synergistic effect on tumor regression. These two main aspects will be assessed in this trial.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of CD20+ B cell lymphoma subtypes: marginal zone lymphoma, grade 1-2 follicular lymphoma, plasmocytic lymphoma, small lymphocyte lymphoma
* conjunctival localization alone (1EA stage; mono- or bilateral)
* at least one measurable lesion
* age \>/= 18 years
* ECOG-PS \</=3
* HIV 1-2 negativity
* at least one previous treatment (antibiotic or rituximab)

Exclusion Criteria:

* concomitant conventional (chemo-, radiation, immuno-), experimental (antibiotic) or corticosteroid anticancer therapy
* known allergy to rituximab
* systemic symptoms
* concurrent diagnosis of pemphigus
* postsurgical conjunctival scars
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy

This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.

To date,hypoxic ischemic encephalopathy is refractory, including after carbon monoxide poisoning, cardiopulmonary resuscitation,hemorrhagic shock and cerebral infarction etc. We used Mesenchymal Stem Cells via portal vein infusion method to treat hypoxic ischemic encephalopathy. With different durations of follow-up, we cleared therapeutic effect, the quality of life and prognostic implications of the cord blood stem cell infusion on hypoxic ischemic encephalopathy, and evaluated the adverse reactions, through the neurological function score (NIHSS，Barthel Index), cognitive score (MoCA, MMSE),and the international uniform Parkinson Rating Scale score (UPDRS). Here, we seek new means for the treatment of hypoxic ischemic encephalopathy, and provide the basis for clinical for further application of umbilical cord blood derived Mesenchymal stem cells.

On the basis of conventional therapy, at the same time, selected patients were given by intravenous infusion of umbilical cord blood stem cells 100-800 million. All patients before treatment, after treatment for 15days, 90days and 180 days were evaluated respectively the curative effect. The neurological function score (NIHSS score, Barthel Index) was observed in patients with the ability to live independently and prognosis; MoCA, MMSE were used in the evaluation of cognitive function ；UPDRS was used in the evaluation of extrapyramidal tract function.

Eligibility Criteria:
Inclusion Criteria:

Patients are screened foe enrollment in the study if both clinal signs and laboratory tests meet the diagnosis standards recommended by International Classification of Diseases-10 about hypoxic ischemic encephalopathy.

Exclusion Criteria:

Exclusion Criteria are any clinically significant diseases in liver,kidney,and heart. additional exclusion criteria are no pregnancy,no immunosuppressive medication, no tumor, no viral diseases or diseases associated with immunodeficiency.
Feeding Intolerance Risk Prediction Model in Patients With Enteral Nutrition Through Nasogastric Tube

To explore the risk factors of enteral feeding intolerance in critically ill patients, build a risk prediction model and verify it, in order to provide reference for early identification and screening of high-risk groups

Based on the previous literature study, the risk factors of enteral feeding intolerance in critically ill patients were obtained, and the general demographic, disease and treatment information of patients were collected. Four machine learning algorithms, namely traditional logistic regression, random forest, support vector machine and naive Bayes, were used to construct risk prediction models, and the optimal model was selected and verified by comparing the model performance

Eligibility Criteria:
Inclusion Criteria:

* The nutritional status of the patient is assessed by the doctor and the need for enteral nutrition is determined;Patients with first nasogastric tube insertion and successful enteral feeding;There was no gastrointestinal discomfort before enteral nutrition;Patients (or family members) authorized to participate in this study and signed informed consent

Exclusion Criteria:

* Previous gastrointestinal disease or gastrointestinal surgery;enteral nutrition through gastrostomy tube or jejunostomy tube;discontinuation or suspension of enteral nutrition for special reasons other than feeding intolerance;Patients with serious lack of clinical data
Effect of Gabapentin on Pain of the Second Cataract Surgery

Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial, bilateral cataract surgery.

Hyperalgesia occurring at the second operation in bilateral eye surgery is well known, and mechanism of central sensitization might be involved. Gabapentin is known to lower the effect of central sensitization, and its effect on acute postoperative pain has been reported. Therefore, pretreatment of gabapentin after first operation may reduce the pain at second operation.

Eligibility Criteria:
Inclusion Criteria:

* Patient of ASA(American Cociety of Anesthesiology) class I, II, III between age 20 to 80, scheduled for serial bilateral cataract surgery(1 weel interval)

Exclusion Criteria:

* refuse to participate
* BMI\<16 or BMI \>30
* severe cardiovascular, pulmonary, renal disease
* alcohol or drug abuse
* currently taking CNS(central nervous system) inhibitory drugs
* taking antiacids
* depressive disorder pregnancy