cyrilzakka/clinical-trials huggingface dataset:
Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force

PHAGEFORCE is a prospective, observational registry study. The University Hospitals Leuven has approved the application of phage therapy as standard-of-care only in patients for whom no curative treatment alternatives (antibiotic and/or surgical) are available ('last-resort cases'). A multidisciplinary phage task force, referred to as the Coordination group for Bacteriophage therapy Leuven (CBL) was set up. The CBL screens patients with difficult-to-treat infections, evaluates who could benefit from phage therapy and sets up the treatment protocol. With this study, the CBL aims to gain insight in the safety and efficacy of phage therapy by integrating and optimizing phage therapy in five distinct medical disciplines (with distinct routes of administration), facilitating long-term follow-up of patients. Furthermore, this study will gain insight in the biodistribution and exact mechanisms of action of phage therapy and thus be able to provide standardized guidelines for each patient population and route of administration.

Patients with difficult-to-treat musculoskeletal infections, chronic rhinosinusitis, sepsis, pulmonary infections associated with cystic fibrosis or bronchiectasis, or hidradenitis suppurativa, for whom no standard (curative) treatment options are available, are eligible for phage therapy. Patient eligibility is evaluated by the Coordination group for Bacteriophage therapy Leuven. If phages are available against the isolated bacterial species and the patient is found eligible for phage therapy, a phagogram is performed. Solely based on the results of the phagogram, the patient is either included in the phage treated or control group (standard (non-curative) treatment). In both cases, data is collected using REDCap.

Eligibility Criteria:
Inclusion Criteria:

All patients:

* Diagnosed with a musculoskeletal infection or chronic rhinosinusitis or sepsis or lung infection (CF/Bx) or hidradenitis suppurativa, and
* For whom all previous treatments (surgical and antibiotic) have failed or for whom no other treatment options are available (i.e., last resort cases, based on the assessment of the CBL), for example in case of bacterial resistance. And
* Of whom the pathogen causative for the infection is one for which phages are available in the phage bank, and
* Who have given informed consent to have their data collected in a patient registry

Exclusion Criteria:

All patients:

* With an infectious disease other than those mentioned above, and/or
* For whom standard treatment alternatives are still available. And/or
* Of whom the pathogen causative for the infection is not one for which phages are available in the phage bank. And/or
* Who refused to give their informed consent
Satiety Response of White and Brown Rice Compared to Glucose Control

The investigators hypothesize that consumption of either white or brown rice will be more satiating than glucose control.

This study is an acute, randomized, repeated measures design with 20 subjects. Subjects will consume 3 test breakfasts, white rice, brown rice, or glucose control, each containing 400 calories. Treatments will be one week apart. After consumption of the controlled breakfast, subjects will complete visual analogue scales (VAS) for satiety response. Additionally, they will consume a pizza lunch and record food intake for the next 24 hours. Breath gas samples will be collected to estimate fermentation of fiber in the large intestine. Also, subjective data on gastrointestinal tolerance will be collected.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* inability to consume rice for breakfast
Use of Bemiparine as a Prophylactic Antithrombotic Agent, in Patients Undergoing Microsurgery for Head and Neck Reconstruction

A comparative study to reveal if the use of Bemiparine (Hibor) versus Enoxaparin (Clexane) as an antithrombotic agent, shows an advantage on the rate of thrombotic and haemorrhagic events in microsurgicals free flaps during head and neck reconstruction.

This is an observational post-authorization study on a group of patients undergoing microsurgery on the Oral and Maxillofacial Surgery and Plastic and Reconstructive Surgery Service at Ramon y Cajal Hospital, Madrid for processes that require reconstruction with a flap microvascular. A group of 67 patients treated according protocol postoperative prevention of deep vein thrombosis with Bemiparina will be compared with data collected retrospectively from a group of 134 patients treated previously with an earlier protocol with enoxaparin as main antithrombotic agent.

Eligibility Criteria:
Inclusion Criteria:

* Patients that will undergo reconstructive surgery for defects in any part of the body, especially in head and neck, after cancer, traumatic or infectious pathology, which will require the use of techniques of microsurgery.
* Patients who have given their informed consent
* Patients in which it has been decided to use thromboprophylaxis with bemiparina before proposing them to participate in the study.

Exclusion Criteria:

* Patients not eligible for repair through the use of free flaps, and therefore the use of Microsurgical techniques for vascular anastomosis
* Patients with an underlying pathology that may interfere to a clinically significant or contraindicated the use of Bemiparina, such as: serious hepatic or renal insufficiency, uncontrolled arterial hypertension, history of gastroduodenal, thrombocytopenia, nephrolithiasis or uretrolitiasis and vascular disease ulcer of choroid and retina.
* Refusal of the patient or their family members to participate in the study.
* Pregnancy and breastfeeding
* Known hypersensitivity to study drugs or any of its components
Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD).

Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance. Eligible subjects will be randomised to treatment after a one-week run-in period. The duration of the treatment period is 24 weeks. An estimated 1000 subjects will be screened to reach the target enrolment of approximately 600 randomised subjects.


Eligibility Criteria:
Inclusion Criteria:

* clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
* FEV1/FVC ratio of ≤0.70
* FEV1 ≤ 80% of predicted normal
* 6MWD \< 350m
* male or female outpatients aged ≥40 years of age
* current or prior history of ≥10 pack-years of cigarette smoking
* aspartate transaminase (AST) or alanine transaminase (ALT) \<2x Upper Limit Normal (ULN)
* alkaline phosphatase (alk phos), and bilirubin \<1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
* QTc \<450 msec\* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be \<480msec\* on baseline ECG.

Exclusion Criteria:

* current diagnosis of asthma
* pregnant or lactating
* α1-antitrypsin deficiency
* lung resection
* chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
* exacerbation of COPD within previous 12 weeks
* treatment with roflumilast within previous 2 weeks and throughout the treatment period
* lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
* long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
* participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
* carcinoma that has not been in complete remission for at least 5 years
* current or chronic history of liver disease
* positive Hepatitis B surface antigen or positive Hepatitis C antibody
* Body Mass Index (BMI) \> 35
* known or suspected history of alcohol or drug abuse within the last 2 years
Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia

The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune Thrombocytopenic Purpura (RITP) and explore the further mechanism.

Rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and autoimmune diseases. Many studies have shown that the drug contributes to the expansion of regulatory T cells and preserves the highly suppressive function of autoreactive T cells. Patients with RITP often display a decreased proportion of regulatory T cells by flow cytometer, therefore, the investigators will examine the efficacy of rapamycin in RITP patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnoses of idiopathic thrombocytopenic purpura
* Hormone and immune suppression, splenectomy is invalid

Exclusion Criteria:

* patients had a bad tolerance to rapamycin
* platelet counts \< 10\*10E9/L during the treatment of rapamycin
Treatment and Complications of Musculoskeletal Tumors

Patients being treated for musculoskeletal tumors were included in the study. Their records were reviewed retrospectively and data was gathered regarding types of surgeries and post-operative complications including recurrence or development of secondary tumors if any.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing treatment for musculoskeletal tumors

Exclusion Criteria:

* Patients who did not undergo any surgical intervention
Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma

The aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients subjected to resection of primary duodenal adenocarcinoma

Exclusion Criteria:

* None.
Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy

Both ciprofol and remimazolam have been found to be potential alternatives to propofol (a commonly used anesthesia) during fiberoptic bronchoscopy, while the efficacy and safety between ciprofol and remimazolam have not been reported. This study aims to compare the efficacy and safety between ciprofol and remimazolam in patients undergoing fiberoptic bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. male or female patients with age ≥ 18 years old;
2. scheduled to undergo bronchoscopy under laryngeal mask airway;
3. with American Society of Anesthesiologists (ASA) physical status classes II to Ⅲ; and
4. volunteering to participate in this study and signing an informed consent form.

Exclusion Criteria:

1. with contraindications to deep sedation/general anesthesia or with a history of sedation/anesthesia accidents;
2. allergic to eggs, bean products, or experimental drugs (ciprofol, sufentanil, or remimazolam);
3. difficult airway;
4. with bradycardia or other serious cardiovascular diseases;
5. with severe damages or diseases in important organs such as the lungs, brain, liver, or kidneys;
6. using sedatives or antidepressants for a long time;
7. pregnant or lactating women; and (8) unable to communicate or cooperate.
Tele-yoga and Dystonia

The purpose of this study is to investigate the effect of yoga delivered remotely on adults with dystonia. This work will have implications related to physical interventions symptom management and quality of life as well as implications related to the role of tele-therapy.

This is a single group intervention study of adults (18-80 years-old) with dystonia symptoms undergoing a 6-week intervention of 30 minute yoga classes delivered remotely through videoconferencing 2-3 times a week. Subjects with cervical dystonia will complete yoga classes delivered at-home with videoconferencing, receiving one-on-one yoga instruction including breathing, postures, and meditation/relaxation for two to three times a week. Data collection will occur remotely via videoconferencing at 0-weeks (baseline), 6-weeks (after the intervention), and 12-weeks (follow-up). Data collection will include demographics, mental health questionnaires, motor assessments, enjoyment, usability, and follow-up yoga status. Each yoga session will be video recorded to aide in recording adherence, adverse events, and challenges.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of cervical dystonia
2. 18-80 years old
3. Ability to communicate verbally and follow directions
4. English-Speaking
5. Subject has access to WiFi and applicable technological device (computer, laptop, tablet, smartphone etc)
6. Subject is willing to be video recorded during the yoga session
7. Subject is willing to open Zoom on their technological device
8. Subject feels comfortable using a technological device for the intervention (ie demonstrates self-reported technological literacy)

8) if they are a U.S. resident, they must be a New Jersey resident and will participate in a majority of the intervention sessions from New Jersey. International enrollment will be considered on a case-by-case basis based on the Physical Therapy Licensure regulations of the appropriate Physical Therapy board.

Exclusion Criteria:

1. Diagnosis of major depressive disorder,
2. Injury or condition that could prevent the ability to engage in yoga poses based on self-report
3. Cognitive impairment or condition that would prevent the subject from understanding the tasks or communicating with the research team
4. Past yoga experience exceeding 5 or more times within the last 2 months
5. pregnant women
6. No access to a technological device (such as a smartphone, computer, laptop, or tablet) or access to WiFi that can be used to access the teleconferencing medium
7. If the subject does not want to be recorded during the yoga sessions
Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

Sleeve gastrectomy (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Recently SG is viewed as a multi-purpose bariatric procedure that restricts the stomach size to induce satiety and resects fundal ghrelin-producing cells to decrease appetite. However, the risk of staple line leak and bleeding remains one of its challenging complications. Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is to date, no consensus on which technique is best for reducing the risk of stapler line bleeding and leak. Hence, this study aims to compare staple line suturing reinforcement methods in sleeve gastrectomy using plication and over-sewing techniques.


Eligibility Criteria:
Inclusion Criteria:

- Patients at our Bariatric Clinic fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic sleeve gastrectomy as primary bariatric procedure will be evaluated for possible inclusion

Exclusion Criteria:

1. Age \< 18 or \> 65
2. BMI \< 35 and \> 60 kg/m2
3. American Society of Anesthesiologists (ASA) score \> 3
4. Concurrent surgical procedure including:

   1. ventral hernia repair
   2. cholecystectomy
   3. hiatal hernia repair with posterior cruroplasty
   4. extensive lysis of adhesions
   5. other procedures that mandate addition of 'trocar(s)' or 'feeding tube'
Biochemical Markers and 2 and 3D Ultrasound to ID Maternal & Fetal Complications

Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies and predict maternal and fetal complications?

Pts will be consented upon presenting to the department for a comprehensive ultrasound.The 3D picture is the only part of the study that is not part of standard obstetrical care.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at approximately 20 weeks
* ages 18-50
* singleton pregnancy
* plans to deliver at North Shore University Hosp
* completed step-wise sequential screening

Exclusion Criteria:

* multifetal gestation
* minors
* patients who have undergone diagnostic genetic testing
* incarcerated patients
* intention to deliver at a hospital other than North Shore University hosp
Clinical Trial in China for Aortic Valve Stenosis

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.

This study is a prospective, multicenter, single-arm, clinical study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65;
2. Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II;
3. Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team \[defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50);
4. Aortic valve anatomy is suitable for TAVR evaluated by the investigators;
5. Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria:

1. Active endocarditis;
2. Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure;
3. Cerebrovascular accident (CVA) occurred within 30 days before procedure;
4. The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium;
5. Hypertrophic obstructive cardiomyopathy;
6. Other valve diseases that need interventions;
7. Previous aortic valve implantation (mechanical or biological);
8. Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products;
9. Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR;
10. In presence one of the following (from selection to the day of procedure index): a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion;
11. Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%;
12. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
13. Hepatic encephalopathy or acute active hepatitis;
14. Receiving hemodialysis;
15. Bleeding tendency or history of coagulopathy or refuse to receive transfusion;
16. Active gastrointestinal (GI) ulcer or bleeding;
17. Severe dementia;
18. Patients who need emergency surgery for any reason;
19. Patients are participating in other drugs or medical devices clinical trial;
20. Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study);
21. Other inappropriate occasions according to the investigators.
Refractive Accuracy of "2WIN" and Portable Autorefractors

Youth and some adults have photoscreening refractions and hand-held auto refraction before cycloplegia refraction during new and follow up eye examinations. Vector math is applied to each refraction to determine how closely the hand-held "dry" devices match actual refraction.

A closeness-of-fit algorithm utilizing vector transformations of astigmatism is designed and applied to 50-years of clinical international refractive experience.

As a part of new and follow up comprehensive eye examinations, patients and parents consented to confirm the cycloplegic refraction to other portable refractive tools.

The ability of photoscreeners "2WIN" ("Adaptica," Padova italy), "PlusoptiX A12" (Nuremberg, Germany) and "Retinomax" (Righton, Tokyo, Japan) to match actual refraction is assessed utilizing the new algorithm.

This algorithm could then be applied to batches of donated spectacles distend by charitable organizations worldwide if portable auto refracting devices are employed.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing new or follow examination at pediatric eye and adult strabismus clinic Willing to undergo screening refractive device developmental delays included

Exclusion Criteria:

* Intraocular lens in place
Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer

This study wants to find out how safe and effective the use of Folfirinox combined with Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.

The study will be a prospective, non-randomized, single center, trial to assess the effects of FOLIRINOX chemotherapy with SBRT on locally advanced, non-resectable pancreatic cancer. Patients will either undergo a biopsy to confirm the diagnosis or have strong clinical suspicion of a new cancer or recurrence based on the recommendations of a multi-disciplinary GI oncology team. FOLFIRINOX with be delivered prior to SBRT for 4 cycles. Restaging imaging will occur prior to SBRT delivery. SBRT will be delivered using standard stereotactic techniques to a dose of 3200cGy at 650cGy per fraction delivered over 2 weeks. Additional adjuvant chemotherapy with be delivered at the physician's discretion. Patients will be reassessed both clinically and radiographically at 3 months, 6 months, 9 months and 12 months post-treatment. Quality of life analysis will occur at 3 month intervals after treatment. Blood will be drawn for exploratory biomarker analysis at strategic timepoints during treatment and followup. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* ECOG performance status 0-1
* Pathologic or clinical diagnosis of a new pancreatic adenocarcinoma. A reasonable attempt should be made to make a pathologic diagnosis of malignancy.
* Imaging as follows:

  * CT scan of the chest, abdomen and pelvis with IV and oral contrast within 8 weeks of registration
  * Whole body PET scan within 8 weeks of registration
* Evaluation by a surgical oncologist to determine non-resectability
* Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
* CBC/differential obtained within 14 days prior to registration with adequate bone marrow function as follows:

  * ANC \> 1,500 cell/mm3
  * Platelets \> 100,000 cells/mm3
  * Hemoglobin \> 8.0 g/dl (transfusion to obtain this value is permissible)
* Additional labs within 14 days prior to registration

  * CA 19-9
  * Creatinine \<2mg/dl
  * Bilirubin \<2mg/dl
  * AST and ALT \< 2.5 x ULN
* Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

* Metastatic disease as defined by the multi-disciplinary team
* Prior anti-cancer therapy for a pancreatic tumor
* Prior malignancy within the last 3 years.
* Pregnant women or lactating women
* Acquired Immune Deficiency Syndrome (AIDS) based on CDC criteria. However HIV testing is not manditory for this protocol
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects