cyrilzakka/clinical-trials huggingface dataset:
POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units

The purpose of the study is to determine the safety of pooled red blood cells (RBCs) compared to standard leukoreduced RBC products stored in additive solution. The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.

This research study is enrolling subjects who are receiving RBC (red blood cell) blood transfusions as part of their treatment. In this study, we are testing a new way of preparing RBC units (pooled RBC units) for transfusion compared to the standard RBC units. We are testing this because blood transfusions may be associated with side effects that may be harmful. We have developed a new way to process RBC for transfusion to try and reduce some of those side effects.

The pooled RBC units will be made by sterilely pooling five (5) single RBC units into one container where the blood will be mixed together, and then separated into five individual RBC units, ready to be used for transfusion. The purpose of the study is to determine the safety of the blood prepared in this new way compared to standard RBC products.

The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.

Eligibility Criteria:
Inclusion Criteria:

* Age\>= 18 years
* Hematology/ oncology or other chronic transfusion dependent patients
* Patients who are in need of transfusion due to low hemoglobin level (\<8 gm/dl)
* Patients who only require one or two transfusion episode of 1-2 RBC units each during 60 day period
* Currently not planning to be pregnant during the study period

Exclusion Criteria:

* Previously identified alloantibodies (other than to D, C, E and K)
* Positive direct antiglobulin test, currently or within the last year
* Emergency transfusion
* Patients \< 18 years old
* Need for specialized products, such as washed
* Patients involved in other RBC transfusion clinical trial
* Currently or planning to be pregnant within the proposed study period
A Relative Bioavailability Study of LY3454738 in Healthy Participants

The main purpose of this study is to look at the amount of the study drug, LY3454738 that gets into the blood stream and how long it takes the body to get rid of it when given under the skin comparing a test formulation versus a reference formulation in healthy participants. The study will also evaluate the safety and tolerability of LY3454738 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 17 weeks, including screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical history and physical examination.
* Have body mass index (BMI) between 18.0 and 28.0 kilograms per meter squared (kg/m²), inclusive, at screening.

Exclusion Criteria:

* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data.
* Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening or intend to during the study.
* Show evidence of active or latent TB.
* Have one of the following infections: hepatitis B virus or human immunodeficiency virus (HIV).
* Participants must not be currently participating in or completed a clinical trial within the last 30 days
Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate

The primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. This study will also gather data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam.

* Radiation therapy to the pelvis and prostate will be given once a day, 5 days a week (Monday-Friday), for 8 weeks. Each treatment takes about 10-20 minutes.
* Participants will be seen once a week for the entire 8 weeks by their study doctor to monitor and record any side effects. At the end of radiation therapy, participants will have a history and physical examination. Follow-up visits with the study doctor will be done at weeks 13 and 26 and then every 6 months for 3 years, then annually to year five.

Eligibility Criteria:
Inclusion Criteria:

* Patients with previously treated adenocarcinoma of the stages T1c-T2b and Gleason of equal to or greater than 5.
* PSA values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy.
* Zubrod status 0-1.
* No evidence of distant metastasis.
* No evidence of other cancer. Prior malignancy does not exclude the patient if disease free for greater than five years.

Exclusion Criteria:

* Clinical stages T2c or above.
* PSA greater than 15.
* Any patient with T1c disease, a PSA less than or equal to 4 and Gleason sum less than 6.
* Evidence of lymph node involvement if lymph node sampling performed.
* Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and cryosurgery.
* Previous prostate radiation.
* Prior hormonal therapy.
* History of inflammatory bowel disease even if currently inactive or controlled on medication.
* Prior systemic chemotherapy.
* History of proximal urethral stricture requiring dilatation.
* Current and continuing anticoagulation with Coumadin or equivalent.
* Major medical or psychiatric illness
Normal and Small Size Mesh in Open Inguinal Herni Repair

Recent years, lots of treatment teqnique have development. We aimed that comparising the normal and small size meshes in the inguinal hernia patients.

Data Collection Method: The research will be a multicentric, prospective and randomized clinical study to be conducted between 01.11.2018 and 28.02.2019 by the general surgery clinics of Mogadishu-Somalia Recep Tayyip Erdogan Training and Research Hospital and Health Sciences University Konya Training and Research Hospital.

Male patients with inguinal hernia repair will be included in the study. Patients will be randomized into two groups. While the normal size of 15 x 7 cm (105 cm2) mesh was used in the first group, In the second group, a small size 11 x 5 cm (55 cm2) mesh will be used.

Dismissal criteria are; Female patients, relapse hernias, bilateral inguinal hernia, laparoscopic hernia repair, diabetic patients using insulin, patients with COPD, peripheral vascular disease, emergency inguinal hernia repair, patients with high ASA score, patients with serious cardiological problems, heavy smokers, transfusions during the perioperative period.

Patients will be given clear and understandable information about the study. Patients who agree to participate in the study will receive a consent form explaining that they have participated in the study voluntarily.

Randomization is done by the secretary with a computer program. A note stating which group the patient is in is placed in a closed envelope and an envelope is opened at the preoperative surgery table.

The method of operation will be open inguinal hernia repair (Lichtenstein hernia repair). The patient will be repaired with mesh suitable for the randomization group. Operations will be performed under the supervision of an experienced surgeon or experienced surgeon.

Surgical Method: Patients will receive open inguinal hernia repair, known as Lichtenstein hernia repair. According to the Gilbert classification, the hernia type is recorded in the patient file.

Evaluation of patient characteristics and pain: the researcher will not know in which group the patients are. Demographic features, duration of surgery, hernia type, early postoperative complications, return to work will be recorded in the study forms. If there is a suspicion of recurrence in the physical examination, a recurrence assessment will be performed by ultrasonography and magnetic resonance examination if necessary. Recurrences will be detected at 1, 6, 12, and 24 and recorded on the study form.

Values will be recorded in the form by using the Sheffield Scale in the assessment of chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* ages must be upper 18

Exclusion Criteria:

* Morbit obesity (BMI\>40)
A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness

The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety: There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus and both will be well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* are male or female, 18-55 years of age
* are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation
* have a history of experiencing muscle soreness after moderately strenuous exercise
* are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen
* are able to read, comprehend, and sign the informed consent form
* develop muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the NRS (numerical rating scale) and at least "moderate" on the categorical scale

Exclusion Criteria:

* regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months
* works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)
* allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen
* the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study'
* any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female
* current habituation or history of chronic use of analgesic or drugs or severe chronic pain problems that do not respond to OTC medication and/or requires a prescription analgesic
* currently on chronic NSAID therapy for any reason
* current or recent history of drug or alcohol abuse
* has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment
* has donated blood within the past 30 days
* is unable to swallow whole or large tablets or capsules
* is unable/unwilling to remain at the study center for the 6 hour inpatient observation period.
* participation in an investigational study within the past 30 days of screening
* prior participation in this trial
* site employee or close relative of a site employee directly involved in the conduct or the study or is an employee or close relative of the study doctor.
A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer

This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* female patients, \>=18 years of age;
* HER2-positive breast cancer;
* al least one metastatic site amenable for core biopsy;
* left ventricular ejection fraction \>50%.

Exclusion Criteria:

* prior adjuvant/neoadjuvant Herceptin within past 6 months;
* prior adjuvant taxane therapy within past 12 months;
* use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;
* known bleeding diatheses.
Treatment With Indinavir and Chemotherapy for Advanced Classical Kaposi's Sarcoma

The purpose of this study is to determine the clinical response to daily Indinavir oral administration in association with a conventional chemotherapy based on cycles of systemic Vinblastine +/- Bleomycin in patients affected by advanced classical (non HIV-associated) Kaposi's sarcoma

It has been recently demonstrated that HIV protease inhibitors (HIV-PI) exert direct anti-angiogenic and anti-tumor actions by blocking endothelial and tumor cell invasion and matrix metalloprotease (MMP) activity. Based on this data, we have started a phase II trial for the treatment of HIV-negative patients with CKS with the HIV-PI Indinavir. Indinavir was well tolerated and induced KS regression/improvement in early-stage disease, and prolonged stabilization in late-stage KS. Response required high plasma drug concentrations indicating a "therapeutic" drug threshold, and was associated with a decrease of circulating endothelial cells (CEC), basic fibroblast growth factor and MMP2 plasma levels. However, large, confluent tumor masses were generally not responsive (Monini et al, AIDS 2009). Thus, advanced KS may benefit at best by treatment with IND upon tumor debulking by conventional chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of KS
* Negative HIV ELISA test
* Being classified as stage III or IV
* Age ≥18 years
* Having interrupted any other anti-KS therapy since at least 2 weeks
* Being informed about the nature of the study and having signed the informed consent

Exclusion Criteria:

* Inability to give informed consent
* Presence of other concomitant diseases, neoplasia (excluding cutaneous tumors with limited extension and without diagnosis of melanoma) or any other life-threatening clinical condition that would compromise its compliance to the protocol
* Concomitant treatments (within 2 weeks prior to the study) with systemic immunomodulatory agents (i.e. glucocorticoids used as immunosuppressive agents, interferons) or chemotherapy
* Pregnancy
* Monolateral nephropathy or history of nephrolithiasis during the last 5 years
* Any clinically relevant and persistent alteration of laboratory values observed during screening
Rehabilitation Exercise Using Digital Healthcare System in Patients With Anterior Cruciate Ligament Reconstruction

The study aims to examine the effect of short-term rehabilitation exercise support using digital healthcare system (Uincare homeplus) in the patients with anterior cruciate ligament reconstruction. The study is a two-arm prospective randomized controlled study comparing the effect of rehabilitation exercise digital healthcare system at home with conventional brochure-based home exercise. Limb Symmetry Index (LSI), Pain (using Numerical rating scale), knee joint range of motion (ROM), lower extremities motor power (using Manual muscle test), International Knee Documentation Committee (IKDC) and quality of life using EQ-5D-5L will be evaluation on enrollment, 2-weeks, 6-weeks, 12-weeks and 24-weeks after enrollment.

Anterior cruciate ligament(ACL) is a vital structure in the knee maintaining the stability and due to increased population engaging in sports activities, the ACL injury is becoming more prevalent among young adults. Rehabilitation after ACL reconstruction is essential to restore knee function and many factors including age, degree of sports activities engagement, weight bearing should be considered when organizing rehabilitation programs. Knee joint stiffness and weakness of knee flexor/extensor muscles are common problems following the surgery which are related to improper rehabilitation after ACL reconstructions.

Current method of post-operative rehabilitation is home-based self rehabilitation using brochure, combined with one or two times of education at the hospital before discharge. Patients often find difficulty in doing rehabilitation by themselves at home without supervision which resulted in decreased compliance.

With development of technologies using multi-motion sensor and AR(augmented-reality) system, the investigators have developed a digital healthcare system(Uincare Homeplus) which can supplement patients' rehabilitation at home by giving them proper instructions as well as feedback. In this prospective randomized controlled study, the investigators aim to compare the efficacy of the newlydeveloped digital healthcare system with conventional rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Patient who had anterior cruciate ligament reconstruction surgery
* Patient who is discharged to home after surgery

Exclusion Criteria:

* Patient who had previous history of anterior cruciate ligament reconstruction surgery in the past 6 months.
* Patient who had undergone bilateral anterior cruciate ligament reconstruction surgery.
* Patient who has knee joint disorders (rheumatoid arthritis, osteoarthritis) other than anterior cruciate ligament injury.
* Patient who has neurological deficit or infection in the affected knee joint.
* Patient who has severe comorbidity that inhibits exercise.
* Patient who cannot participate in post surgery rehabilitation
Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

This study aims to validate a possible diagnostic test for bile acid diarrhoea prospectively compared to the SeHCAT scintigraphy. Fasting participants are given a standard meal and 1,250 mg chenodeoxycholic acid. The investigators measure fasting FGF19, bile acids species including 7-alpha-CHO and serial blood samples after the stimulation.


Eligibility Criteria:
Inclusion Criteria:

- Consecutive patients referred for SeHCAT

Exclusion Criteria:

* Treatment with sequestrants within one week before the SeHCAT.
* Treatment with any constipants/laxatives one day before the SeHCAT, with the exception of opioids, if the dosis has been stable in the prior 2 weeks.
* Pregnancy, screening by pregnancy test before inclusion.
* Breastfeeding women.
* Small bowel resection, including right sided hemicolectomy.
* Any ongoing treatment for inflammatory bowel disease with systemic steroids (i.e. budesonide or prednisone) or treatment in the prior 4 weeks.
* Allergies to constituents of Xenbilox: (chenodeoxycholic acid, cornflour, magnesium stearate, highly dispersed silica, gelatine, sodium dodecylsulphate, titanium dioxide (E171), quinolone yellow (E104), erythrosine (E127)
* Chronic or acute cholecystitis.
* Liver cirrhosis,
* Obstructed bile flow causing jaundice or elevated p-bilirubin (\> 1,5 UNL).
* Known disability in gall bladder contractility.
* Bile duct atresia.
* Frequent gallstone attacks (\>2/month).
Levo Phencynonate Hydrochloride for the Prevention of Seasickness

A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.

The trial is composed by 3 parts: 1) On-boat screening period for seasickness and safety tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the impact of voyage experience. 3) On-boat drug testing period. The subjects will be administered the drug before voyage. The seasickness symptoms will be evaluated during voyage. The safety test will be conducted before and after one day of on-boat testing.

Eligibility Criteria:
Inclusion Criteria:

* Subjects fulfilling the diagnostic criteria for motion sickness
* Have medical history for motion sickness
* During screening, the severity of sea sickness is assessed as moderate or above according to sea sickness severity scale.
* Adults for 18-55 years, male or female.
* Agree to participate the study and can sign the ICF independently.

Exclusion Criteria:

* Be allergic to the study drug or be allergic constitution
* ALT, AST≥ 1.5 times of ULN, Scr\>ULN, or other clinical significant lab values.
* Abnormal ECG which is clinical significant judged by investigators, including: QTc\>normal range
* Have medical history for urination disorder
* Have headache, vertigo, dizziness or nsomnia caused by other diseases than motion sickness.
* Have active gastrointestinal diseases or overweight (BMI≥24kg/m2 )
* Have internal ear disease which may disturb the evaluation of motion sickness.
* Have glaucoma or posterior circulation ischemia
* Have anxiety, depression or other mental disease that investigator considering inadaptable to participate the study.
* Participated in other studies within the past 3 months.