cyrilzakka/clinical-trials huggingface dataset:
Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC

The Tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.


Eligibility Criteria:
Inclusion criteria

* ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery.
* Age above 18 years \& less than 65 years.

Exclusion criteria:

* Thrombophilia or any bleeding disorder.
* Previous or active thromboembolic disease.
* Family history of thromboembolism.
* Known Allergy to TA.
* Liver dysfunction.
* Preexisting renal dysfunction (serum creatinine \>1.2 mg/dL).
* Coronary stent insertion within a year prior to operation.
* Cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure),
* Lifelong warfarin therapy for thromboembolism prophylaxis.
SynchroMed II Post-Approval Study

This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers. Subjects are selected from those evaluated and planning to receive a SynchroMed II drug infusion system for treatment of severe spasticity or chronic pain. Subjects must return for refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically necessary refills. Information is collected on all refills and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Have chronic intractable severe spasticity or chronic pain requiring intrathecal delivery of medication
* Have undergone a pre-implant assessment and determined to be an appropriate candidate for implantation of an infusion system
* Be geographically stable and willing to return to the study center for follow-up visits
* Subject, or subject's legal representative, has signed informed consent form prior to any study-related procedures
* Age is at least 18 years of age at time of enrollment

Exclusion Criteria:

* Have a condition in which the pump cannot be implanted 2.5 cm or less from the surface of the skin
* Have an ongoing infection prior to implant
* Have insufficient body mass to accept the pump bulk and weight
* Are unable or unwilling to adhere to the study protocol
* Have an estimated life expectancy of less than twelve months
Improving the Quality of Life of Stroke Patients Using the Armeo Spring Device

The main goal will be to evaluate the effect of improving the quality of movement of the upper limb (using an evaluation exercise in the software of the Armeo Spring device) on the development of the quality of life after stroke using a standardized generic and specific questionnaire.

The secondary outcome will be to evaluate changes in self-sufficiency using a test of daily activities modified by the Frenchay test of daily activities.

The research follows on from a pilot study that took place at the Department of Rehabilitation and Sports Medicine, University Hospital Ostrava from 4/2022 to 9/2022. It has a prospective monocentric randomized trial design. Patients will be randomized into parallel groups - intervention and control groups.

A prospective monocentric randomized study lasting 8 months at the Department of Rehabilitation and Sports Medicine, University Hospital Ostrava. The study design is parallel with a test and control arm. Patients will be divided into an intervention (tested) group A with therapy on Armeo Spring and a control group B with conventional therapy, using a random number generator, where odd numbers represent arm A and even numbers represent arm B. A randomization table randomly allocates patients to therapy according to their order of entry into the study.

Eligibility Criteria:
Inclusion Criteria:

* history of stroke
* age over 18 years
* Modified Rankin Scale (mRS) of 2-3
* moderate paresis of the upper extremity (individuals with shoulder/elbow muscle test values in the range of 3-1)
* cardiovascular stability

Exclusion Criteria:

* age under 18 years
* severe cognitive or sensory deficit and non-cooperation
* severe osteoporosis
* impaired skin integrity in the trunk and upper limbs
* cardiovascular instability
* unstable fractures
* acute inflammatory diseases
Telerehabilitation for Hip and Knee Osteoarthritis

Digital health utilization in the form of telerehabilitation is a popular technology that is very little researched for musculoskeletal disorders particularly hip and knee osteoarthritis (OA). The progression of OA will lead to total hip or knee replacement surgery. As a consequence, the advancing aging population leads to an increased burden on the healthcare system due to rising osteoarthritis. That's why, we will conduct a randomized controlled trial to explore the effectiveness of telerehabilitation in hip and knee osteoarthritis. This study will recruit OA patients into control and experimental groups. The control group will receive a patient education while the experimental group will undergo remote exercise sessions. Both groups will receive one supervised session a week for 5 weeks. The pre- and post-outcome measures will be recorded for functional status of hip and knee, muscle strength, and range of motions of the lower extremity. This innovative study will evaluate the effectiveness of a telemedicine intervention applied to a clinical population in Taiwan. The use of telerehabilitation interventions aims to reduce treatment and transportation costs, as well as save time for patients with OA. This digital health approach also helps to alleviate the workload of physiotherapists and rehabilitation doctors in clinics. The findings from this study could broaden the scope for using remote digital technology to assist clinical patients in diverse settings, especially those with limited or no hospital access.

Purpose: To conduct a randomized controlled trial to explore the efficacy of telerehabilitation intervention for 5 weeks in a clinical population with hip and knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with hip or knee osteoarthritis within last one year
2. having sub-acute or chronic symptoms of pain and functional disability
3. living in an area served by high-speed Internet services (at least 512 kb/s in upload)
4. living within an hour driving distance from the treating hospital
5. physically fit to provide a written consent to participate in this study

Exclusion Criteria:

1. taking sedatives, autoimmune, or other medication that can interfere with their exercise program
2. any health issues that could affect the tests or the rehabilitation program, including surgery over the recent six months
3. having diagnosed with cognitive disorders
4. having recent surgery or major postoperative complications
Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers

The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.

In this open-label study, volunteers are given an intramuscular injection of GENEVAX-HIV vaccine using the Biojector 2000. Safety measures and immune response are assessed accordingly.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are 18 - 60 years old.
* Are HIV-negative and in good health.
* Are able to understand how infections such as HIV are spread.
* Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have hepatitis B or C.
* Have any condition that may prevent you from completing the study.
* Are allergic to bupivacaine, vaccines, or certain local anesthetics.
* Have taken certain medications or have received certain therapies that may affect your immune system.
* Have an immune system disorder or have received therapy for an immune system disorder.
* Have been exposed to HIV within 6 months prior to study entry.
* Have received an experimental HIV vaccine or any other experimental treatment within 30 days prior to study entry.
* Have received blood transfusions within 6 months prior to study entry.
* Abuse alcohol or drugs or have an uncontrolled psychiatric disorder.
* Are pregnant or breast-feeding.
Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients

The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and vomiting and is also approved for post-operative nausea and vomiting. The investigators' evaluation of it in morbidly obese patients will demonstrate its ability to control nausea and vomiting post-operatively in this subset of patients.

The purpose of this study is to evaluate the effectiveness of Aprepitant, also known as Emend, in reducing post-operative nausea and vomiting in morbidly obese patients. Post-operative nausea and vomiting that occurs in morbidly obese patients can greatly increase the chances of complications during the post-operative period. By treating morbidly obese patients with Aprepitant, the goal is to reduce the risk of such complications that may be induced by nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

Subjects included in this study must be:

* Female
* At least 18 years of age
* Non-smoking
* At high risk for PONV
* Obese with a BMI of at least 45 kg/m2
* Undergoing upper gastrointestinal surgery requiring postoperative opioid analgesia

Exclusion Criteria:

Subjects will be excluded if:

* They have a known allergy to Aprepitant or Ondansetron
* They are currently taking Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole), or Propulsid (cisapride)
* They are pregnant
* They are breastfeeding
* They plan on getting pregnant in the 2 months following surgery
* They are not able to receive patient controlled analgesia (PCA) following surgery
* They have a known drug or alcohol abuse problem
* They have chronic nausea and vomiting
Disease Modification in Toxaemia of Pregnancy

Short description of the primary purpose of the protocol intended for the lay public. Include brief statement of study hypothesis

Pre-eclampsia (toxemia of pregnancy) is the most cause of death among pregnant women in North America. It also causes many complications for fetuses (unborn children) and neonates (newborn children). Pre-eclampsia is defined by high blood pressure (hypertension), the loss of protein into the urine (proteinuria), and disorders of many body systems, including the blood clotting (coagulation) and inflammation. What is needed is a compound that will safely prolong pregnancies, to give babies more time to grow inside their mothers, and will help the recovery in those mothers after delivery.

We are going to investigate a compound (recombinant human activated protein C (rhAPC)) that has the potential to modify disease activity in pre-eclampsia by reducing coagulation and inflammation disorders. rhAPC is effective in patients suffering from septic shock. We will test rhAPC in women who develop severe pre-eclampsia in two ways. First, in women with severe pre-eclampsia remote from term who are carrying small babies (intent: safely prolong their pregnancies). Second, in women who have had severe pre-eclampsia before their baby delivered (including women in the first group), or whose disease develops/worsens after delivery (intent: switch off the disease so dangerous complications do not arise).

This study is a preliminary one to look for possible risks and benefits for these women. Only 40 women will be studied to provide initial evidence on which to base a larger international trial which is planned. We will study their pregnancy outcomes as well as markers of disease activity, to gain a better understanding of the mechanisms by which these women become unwell.


Eligibility Criteria:
Inclusion Criteria:

* Scenario 1 is severe early-onset pre-eclampsia, where the fetal prognosis is dismal (\<50% chance of intact survival \[disease onset \<27+0 weeks gestation and/or estimated fetal weight \<600g\].
* Scenario 2 is postpartum pre-eclampsia, where there is either severe antenatal disease, deteriorating postpartum disease, or de novo postpartum disease.

Exclusion Criteria:

-
Budesonide for Maintenance Treatment of Collagenous Colitis

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Eligibility Criteria:
Inclusion Criteria:

* collagenous colitis
* diarrhea
* written informed consent

Exclusion Criteria:

* infectious causes for diarrhea
* other inflammatory bowel diseases
* history of colonic surgery
* celiac disease
* malignancies
* severe concomitant diseases
* use of budesonide, steroids, mesalazine within the previous 2 weeks
* known intolerance to budesonide
* history of lack of response to budesonide
* pregnancy,lactation
* drug and/or alcohol abuse
* lack of compliance
A Call Center During HAE Attacks (SOS HAE)

This clinical trial aims to compare morbidity and cost associated with acute attacks of hereditary angioedema in patients with an intervention based on a support after a phone call to the call center (SOS HAE) from a group of patients does not change their practice.

Investigators propose a study to determine whether a call center for an acute attack of HAE associated with intervention recommendations based on systematic early treatment (self-administration at home or by a caregiver) would reduce the morbidity and the socioeconomic impact.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an hereditary angioedema followed in a reference center for bradykinin angioedema (CRéAk)
* Patient's age ≥ 18 years
* Consent to the participation in the study
* Affiliated to social security

Exclusion Criteria:

* pregnant woman
* recent history of myocardial infarction
* recent history of stroke
* allergy to icatibant or C1 inhibitor concentrate
AM-101 in the Treatment of Post-Acute Tinnitus 2

The purpose of this research study is to test the safety and local tolerance of repeated treatment with AM-101.

This open-label extension study is assessing the safety and local tolerance of repeated treatment with AM-101 in subjects previously treated in the scope of the TACTT3 study.

Eligibility Criteria:
Inclusion Criteria:

* Completion of TACTT3 study;
* Negative pregnancy test (woman of childbearing potential);
* Willing and able to attend the study visits.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Adverse event leading to treatment discontinuation in TACTT3;
* Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
* Ongoing drug-based therapy for otitis media or otitis externa;
* Drug-based therapy known as potentially tinnitus-inducing;
* Other treatment of tinnitus;
* Drug abuse or alcoholism;
* Subjects with psychiatric diseases requiring drug treatment;
* Use of antidepressant or anti-anxiety medication;
* Any clinically relevant disorder or abnormality in physical examination;
* Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
* Women of childbearing potential who are unwilling or unable to practice contraception.

Other protocol-defined exclusion criteria may apply.
Reinterventions of Thoracic Endovascular Aortic Repair: a Retrospective Multicenter Cohort Study

We aimed to investigate the incidence of reinterventions in patients who underwent thoracic endovascular aortic repair (TEVAR) in multiple centers across Taiwan

This study analyzed the multicenter data set for TEVAR procedures performed between 2012 and 2017. Each patient's survival was verified with a query to the national data set. Student's t-test and χ2 analysis were used to compare continuous and categorical variables between the groups that required reintervention and those that did not, respectively. Kaplan-Meier methods were applied to analyze freedom from reintervention and survival rates.We aimed to investigate the incidence of reinterventions in patients who underwent thoracic endovascular aortic repair (TEVAR) in multiple centers across Taiwan

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent thoracic endovascular aortic repair (TEVAR)

Exclusion Criteria:

* No thoracic endovascular aortic repair (TEVAR)
Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials

Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in bile duct cancer clinical trials, as well as the reasons for withdrawal or discontinuation.

The insights gained from this study will ultimately benefit those with bile duct cancer who may be invited to participate in medical research in the years to come.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed written informed consent
* Patient has been diagnosed with bile duct cancer

Exclusion Criteria:

* Woman pregnant or susceptible to the being
* Inability to perform regular electronic reporting
* Inclusion in another investigational clinical trial
Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function

To study the effects of MDMA, compared to a prototypical stimulant, on social motivation, social ability, and neural indices of social function in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* BMI between 19 and 30 (no one under 130 lbs)
* Smokers smoking less than 25 cigarettes per week
* Have used ecstasy no more than 40 times with no adverse responses.

Exclusion Criteria:

* High blood pressure
* Any medical condition requiring regular medication
* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
* Individuals with a history of dependence on stimulant drugs.
* Women who are pregnant or trying to become pregnant
Study Correlation Between Blood, Tissue Gene Expression, Donor Derived Cell Free DNA and Histopathology in Kidney Transplant Recipients

This study will compare the performance of Gene Expression Profile (GEP)/ Donor derived cell free deoxyribonucleic acid (dd-cfDNA) tests, to the following tests: Molecular Microscope (MMDx) and histopathology (study of changes in tissues caused by disease) in their ability to diagnose (exactly identify) various types of injury within the transplanted kidney.

This study will evaluate the performance of the blood-based assays like gene expression panel (GEP), and donor derived cell free DNA (dd-cfDNA) against tissue-based assays like molecular microscope (MMDX) and histopathology in their ability to more accurately detect presence of rejection among kidney transplant recipients deemed at higher than usual risk for immunologic injury i.e., rejection.

Furthermore, the study should shed light on the ability of the different blood- based assays to accurately discern between the different types of rejection (early cellular versus humoral) against such confirmed by histopathology and molecular microscope.

The study will also shed light on the ability of these noninvasive biomarkers to be utilized as a tool of immunomodulation in addition to studying their ability to accurately confirm presence of adequately treated rejection among the recipients of kidney transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a for cause biopsy due to ongoing or suspected "injury" of the allograft.
* Patients will be between 3 months and 7 years post-transplant episode.
* Recipients of both cadaveric and living donor renal transplant are considered eligible.

Exclusion Criteria:

* No multi organ transplant recipients will be included.
* Pregnancy
* HIV positive recipients
* Recipients of kidney transplant from an identical sibling
* Patients with active and biopsy proven BK nephropathy
Evaluation of the PK of NRL972 Following Pre- and co-Administration of Ursodeoxycholic Acid and Cloxacillin

A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
2. Caucasian
3. Age: 21 - 40 years
4. BW 50 - 100 kg
5. BMI 20 - 26 kg.m-2
6. healthy based on the pre-study examination
7. willing and able to provide informed consent

Exclusion Criteria:

General - all subjects

1. Previous participation in the trial
2. Participant in any other trial during the last 90 days
3. Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
4. History of any clinically relevant allergy (including hypersensitivity to the trial medications)
5. Presence of acute or chronic infection
6. Presence or history of any relevant co-morbidity
7. Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
8. Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
9. Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
10. Positive serology for HBsAg, anti HBc and anti HCV
11. Positive HIV test
12. Positive alcohol or urine drug test on recruitment (and upon admission)
13. History of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol
14. Smoking more than 15 cigarettes/day or equivalent of other tobacco products
15. Use of prohibited medication
16. Suspicion or evidence that the subject is not trustworthy and reliable
17. Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard

    General - all females
18. Positive pregnancy test
19. Lactating
20. Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods \[condom, diaphragm with spermicidal gel\] should be us