cyrilzakka/clinical-trials huggingface dataset:
Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation

The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how effective it is in preventing graft versus host disease (GVHD)in patients that have received non-myeloablative peripheral blood stem cell transplantation.

* After the screening procedures confirm that the patient is eligible to participate in the research study, they will be admitted to the hospital to receive chemotherapy and stem cell transplantation (SCT). The duration of the hospitalization for the procedure is approximately 8 days.
* Patients will receive fludarabine once daily over 30 minutes intravenously for 4 days and busulfex once daily over 3 hours intravenously each day for the same 4 days.
* Just prior to the transplant and following the transplant the patient will receive sirolimus and tacrolimus to help prevent Graft versus Host Disease (GvHD). Both medications are taken orally.
* Patients will also take medications to help prevent possible infections (e.g. acyclovir). Filgrastim, a white blood cell growth factor, will be given daily in an injection under the skin, starting the day after the stem cell transplant and until the patients blood counts have recovered.
* After the stem cell infusion, the patient will be examined and have blood tests weekly for 1 month. At about the 1-month visit, a bone marrow biopsy and/or blood tests will be performed to determine the percentage of donor's cells in the blood or bone marrow. These tests will be repeated at 3-4 months after transplant.
* At 3-4 months after the transplant, patients will also have tests to reassess the response of your disease to transplant. This may involve a bone marrow biopsy, blood tests, and/or radiology studies depending upon the type of cancer.
* Follow-up will continue for the remainder of the patients life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation
* Availability of a related donor who is identical at 6 HLA loci
* Greater than 18 years of age
* Performance status 0-2
* Life expectancy of \> 100 days

Exclusion Criteria:

* Pregnancy
* Evidence of HIV infection
* Heart failure uncontrolled medication
* Total bilirubin \> 2.0mg/dl that is due to hepatocellular dysfunction
* AST \>90
* Serum Creatinine \>2.0
* Cholesterol \> 300mg/dl while adequately treated
A Biologic Joint Replacement Strategy for Knee Trauma and Post-Traumatic Osteoarthritis

Participants will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation.

With IRB approval, patients will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation. Demographic and operative data will be collected. Outcome assessments will include VAS pain, IKDC, SANE, Tegner and PROMIS Mobility for knee at 6 months and yearly after surgery. In addition, serial limb alignment measurements, ultrasonographic assessments of meniscal location and integrity, quantitative MRIs for cartilage composition, and serum and urine biomarkers for treatment monitoring will be performed. All complications and re-operations will be recorded. OCA survival will be determined based on maintenance of acceptable levels of pain and function and/or need for revision surgery or total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint (unicompartmental) or unicompartmental and other femoral condyle, tibial plateau, trochlea and/or patella.
* Between the age of 18-55

Exclusion Criteria:

* Acute injury to any other part of the affected lower extremity
* Inability to comply with protocol
* BMI greater than 40
* The subject is either pregnant or a prisoner
* Currently involved in worker's compensation case at the time of enrollment
Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care

Women generally report discomfort and a delay in GI motility after CS. The Paula method, circular exercises of ring muscles has been shown to increase GI motility. This method had not been studied in women post CS. The current study is comparing the resumption of bowel sounds after CS in women utilizing the Paula exercises to standard care (no exercises).


Eligibility Criteria:
Inclusion Criteria:

* Elective, singleton, term CS, with spinal or epidural anesthesia

Exclusion Criteria:

* GI/ absorption disorders (Chron's, IBS)
* general anesthesia
* urgent CS
Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-Based Formula

A retrospective chart review to assess feeding tolerance in adults who had been switched from an intact protein formula to a peptide-based formula due to feeding intolerance in a complex continuing care facility.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age on admission to facility
* Prescribed enteral nutrition with the goal to provide at least 90% of estimated daily calorie and protein requirements for ≥ 2 weeks prior to switch
* Received enteral nutrition with an intact protein formula for a minimum of three days prior to a switch to a peptide-based formula
* Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a peptide-based formula
* Receiving a peptide-based formula formula for ≥ 2 weeks
* Have documentation of an assessment of feeding tolerance following the switch
* Formulas received must be indicated for use in adults.

Exclusion Criteria:

* Abdominal surgery (within past 30 days prior to switch)
* Having any infection, including upper respiratory, viral, gastroenteritis,wound infections, c difficile, at time of switch
* Having documented cow's milk protein allergy at time of switch
* Medical records lacking information on rationale for switch to a peptide-based formula and/or response to change (positive, neutral or negative).
the Influence of Prophylactic and Empirical Anti-fungal Treatment in Severe Sepsis Patients With Perforations

This prospective intended to observe the influence of prophylactic and empirical anti-fungal treatment on Severe Sepsis patients with perforations. With the consent of patients' legal guardian for prophylactic use of antifungal agents, patients were divided into two groups: prophylactic group and Empirical group.

Intra-abdominal perforation is the high risk of fungal infection. The flora in digestive tract would colonize and go to the blood to develop severe bacteria and fungal infection in intra-abdominal perforation and about one-third of patients with gastrointestinal perforations or anastomotic leakages in ICU develop intra-abdominal fungal infection. In particular, the severe sepsis arisen from these infections could further increase the mortality. However, empiric/preemptive treatment in most studies failed to improve the prognosis and few of the studies that addressed the influence of prophylactic anti-fungal treatment in patients with GI Perforation.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥16 years
2. the time between gastrointestinal perforations or anastopmotic leakage(s) after abdominal surgery and entering ICU within 6 hours
3. ICU stay of at least 5 days
4. APACHE Ⅱ score within 24 hours of randomization of 16 or more
5. severe sepsis
6. written informed consent -

Exclusion Criteria:

1. documented fungus before gastrointestinal perforations/anastopmotic leakage(s) ongoing antifungal treatment before the study;
2. fluconazole/caspofungin allergy;
3. pregnant of lactating woman;
4. life expectancy of 48 hours or less. -
Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)

Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatment for fungal infection includes not only antifungal medications but also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper treatment of fungal infections would be difficult if not impossible. The investigators believe that giving prophylactic antifungal medication to all children on ECMO may prevent fungal infections from developing in the first place.

Fluconazole is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the potential to significantly alter the drug levels of medications so the investigators do not know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data and modeling from other studies, the investigators think 25mg per kilogram given once weekly will achieve proper drug levels to prevent fungal infections. The investigators have obtained FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the study. Blood samples will be collected at specific times around the first and second fluconazole doses to describe the PK and drug extraction by the ECMO circuit.


Eligibility Criteria:
Inclusion Criteria:

1. \<= 17.5 years at the time of enrollment.
2. Sufficient venous access to permit administration of study medication.
3. Supported with either venoarterial (VA) or venovenous (VV) ECMO.
4. Availability and willingness of the parent/legal guardian to provide written informed consent.

Exclusion Criteria:

1. Subject with a history of anaphylaxis attributed to an azole.
2. Any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
3. Previous participation in this study.
4. Subjects who are receiving or who have received cyclosporine, tacrolimus, or azithromycin in the 72 hours prior to first dose of study product require protocol chair notification prior to enrollment.
5. Pregnancy
A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD

Bone marrow transplant (BMT) patients can develop graft-versus-host disease (GVHD), a serious and potentially fatal complication. The researchers have developed a blood test to identify patients most at risk for developing severe GVHD. Patients who consent to this study will have their blood tested up to two times after BMT to determine if they are at high risk for severe GVHD. The tests will be performed one week and two weeks after BMT. Patients who are high risk will be treated with a drug called alpha-1-antitrypsin (AAT) to see if it prevents the development of severe GVHD. Patients will receive 16 doses of AAT through a catheter placed into a blood vessel over eight weeks. AAT will be given either in the hospital or the outpatient clinic two times per week. Patients will be followed for the development of severe GVHD for up to four months from the BMT and will continue to be followed at routine clinic visits for up to one year after BMT.


Eligibility Criteria:
Inclusion Criteria:

* High risk prediction score as determined by the Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm at either day 7 or day 14 post Hematopoietic cell transplant (HCT).
* Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood).
* Donor and recipient match each other for at least 7/8 HLA-loci (HLA-A, B, C, and DR)
* Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.
* GVHD prophylaxis must include a calcineurin inhibitor combined with methotrexate or mycophenolate.
* The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted
* Direct bilirubin must be \<2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
* ALT/SGPT and AST/SGOT must be \<5 x the upper limit of the normal range within 3 days prior to enrollment.
* Signed and dated written informed consent obtained from patient or legal representative.

Exclusion Criteria:

* Patients who develop acute GVHD prior to start of study drug
* Patients at very high risk for relapse post HCT as defined by very high disease risk index
* Patients participating in a clinical trial where prevention of GVHD is the primary endpoint
* Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
* Patients who are pregnant
* Patients on dialysis within 7 days of enrollment
* Patients requiring ventilator support or oxygen supplementation exceeding 40% FiO2 within 14 days of enrollment.
* Patients receiving investigational agent within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of alpha-1-antitrypsin.
* History of allergic reaction to alpha-1-antitrypsin
Clinical Trial to Evaluate the Effectiveness and Safety of a Remote Automated Ultrasound Diagnostic System for Automated Ultrasound Examinations: a Prospective, Multicenter Study

The purpose of this clinical trial is to verify the safety and effectiveness of the remote automatic ultrasound diagnosis system produced by Wuhan Cooper Technology Co., Ltd. for automatic ultrasound examination. It aims to answer the main questions:

Can the robot complete automatic ultrasound scanning of multiple systems and organs such as liver, gallbladder, spleen, pancreas, kidney, thyroid, carotid artery, etc.? Will there be medical safety issues during the robot\&#39;s scanning process?


Eligibility Criteria:
Inclusion Criteria:

* 1) Aged ≥ 18 years old, regardless of gender; 2) Those who need to undergo ultrasound examination; 3) Those who voluntarily participate in this trial and sign the informed consent form.

Exclusion Criteria:

* 1) Those who are allergic to ultrasound coupling agents; 2) Those who are unable to undergo long-term ultrasound examinations due to physical or mental reasons (such as intellectual disability, mental illness, etc.); 3) Those who have suffered severe trauma or burns within the past month; 4) Pregnant or breastfeeding women; 5) Those who have participated in other clinical trials within the past month; 6) Other subjects deemed by the researchers to be unsuitable for participating in the trial.
Pulmonary Hypertension Institutional Registry

The purpose of this study is to create a registry of patients with Pulmonary Hypertension who received medical care in the Hospital Italiano of Buenos Aires.

The Institutional Registry of Pulmonary Hypertension includes patients prospectively with incident pulmonary hypertension, and excludes type II Pulmonary Hypertension. It also includes prevalent cases from our HMO who had diagnosis prior the beginning of the registry.

Eligibility Criteria:
Inclusion Criteria:

* More 17
* Pulmonary Hypertension
* Systolic Pulmonary Pressure \>40 mmhg measured in a doppler echocardiogram,
* Systolic artery pressure \<25 in a pulmonary angiography

Exclusion Criteria:

* Non accept to participate
* Pulmonary Hypertension type II (Left cardiac disease)
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With FOLFOX4 in Subjects With Advanced HCC Who Have Never Received Prior Systemic Treatment.

The study is being conducted to evaluate the efficacy and safety of SHR-1210 plus FOLFOX4 in subjects with advanced HCC who have never received prior systemic treatment compared to placebo plus FOLFOX4.

The primary study hyposis is that Camrelizumab combined with FOLFOX4 treatment can improve Overall Survival when compared with placebo in combination with FOLFOX4 Regimen.


Eligibility Criteria:
Inclusion Criteria:

Has not received prior systemic treatment for their advanced/metastatic HCC. Has measurable disease according to RECIST v1.1. ECOG Performance Status of 0 or 1. Child-Pugh Class A or B with 7 points. Life Expectancy of at least 12 weeks. HBV DNA\<500 IU/ml. Adequate organ function： Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.

Exclusion Criteria:

Known fibrolamellar HCC, Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.

Known or occurrence of central nervous system (CNS) metastases. Ascites with clinical symptoms. Known or evidence of GI hemorrhage within the past 6 months. Known or occurrence of hemorrhage/ thrombus. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.

Grade III\~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%.

Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 150mmHg, diastolic blood pressure \> 90 mmHg).

History of hepatic encephalopathy. Known history of human immunodeficiency virus (HIV) infection. Active infection or an unexplained fever \> 38.5°C during screening visits. Prior or planning to organ transplantation including liver transplantation. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.

Proteinuria≥ 2+ and 24 hours total urine protein \> 1.0 g. Active known, or suspected autoimmune disease. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.

Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study.

Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs.

Pregnant or breast-feeding women. According to the investigator, other conditions that may lead to stop the research.
Study of 0.1% Uracil Topical Cream (UTC) for the Prevention of Hand-Foot Syndrome

The purpose of this research study is to see if combining uracil cream (UTC) with capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects UTC and capecitabine may have in patients with metastatic breast cancer.

Capecitabine is used in the treatment of human breast cancer among other human cancers. Following absorption, capecitabine is converted enzymatically to 5-fluorouracil (5-FU). The administration of capecitabine or 5-FU can cause a cutaneous toxicity known as hand-foot syndrome (HFS) or palmar-plantar erythrodysesthesia (PPE). HFS is progressive with dose and duration of exposure to 5-FU or capecitabine. HFS is characterized by progressive redness and cracking of hands and feet. Currently, there are no approved therapies for HFS.

Eligibility Criteria:
Inclusion Criteria:

* Females, at least 18 years old
* Histologically or cytologically confirmed metastatic breast cancer
* You also cannot have any ulcerations or open wounds on palms of hands or soles of feet

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C)prior to entering the study or if you have not recovered to Grade 1 or better (except for alopecia)from adverse events due to agents administered more than 2 weeks earlier.
* Use vitamin 6, chronic use of Cox-2 inhibitors, use full-dose anti- coagulants or use nicotine patches.

The above is not a complete list of eligibility criteria. Please see your study doctor for more information.
Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial

The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family.

In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.

Gastroesophageal reflux disease (GERD) and its troublesome complications constitute serious diagnostic and management challenges to the development of safe feeding and airway protection strategies among infants convalescing in the neonatal intensive care units; thus contributing to prolonged lengths of stay, recurrent hospitalizations, and death. GERD is frequently diagnosed by inadequate criteria, and the relative risks, benefits and indications of GERD therapies are unclear. Significant gaps in knowledge exist in understanding the complex causal or adaptive aerodigestive protective reflex mechanisms implicated in GERD in infants. The long-term goal is to improve digestive health, nutrition, and infant development through the design of simplified personalized treatment paradigms by better understanding the pathophysiology of aerodigestive reflexes.

The current objective is to conduct a prospective single center randomized blinded controlled trial comparing the short term effects of the investigators innovative feeding strategy bundle (study approach) versus standard feeding approach (conventional approach).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized infants with aerodigestive or GERD symptoms
* Gestational age ≤42 weeks
* Premature infants are eligible at 34 weeks postmenstrual age (PMA)
* Enteral or Oral Fed
* Average daily total feeding volume ≥ 150ml/kg/day
* Room air or supplemental oxygen of ≤1 liter/minute (LPM) and/or ≤ 35% by nasal cannula

Exclusion Criteria:

* Known genetic, metabolic or syndromic disease
* Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH) and perinatal asphyxia
* Gastrointestinal malformations and surgical gastrointestinal conditions