cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple subcutaneous injections of HRS9531 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
2. Age 18-55 years on the date of signing informed consent (inclusive);
3. Body weight ≥50 kg, body mass index (BMI) within the range of 19.0-35.0 kg/m2 (inclusive);
4. Subjects with good general health, no clinically significant abnormalities.

Exclusion Criteria:

1. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study;
2. Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;
3. Participants in clinical trials of any drug or medical device in the 3 months prior to screening;
4. Blood donation history or blood loss ≥400 mL within 1 month before screening, or received blood transfusion within 2 months;
5. Allergic constitution includes severe drug allergy or history of drug allergy;
6. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive;
7. Breast-feeding women;
8. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant

The purpose the research is to obtain preliminary data about the change in fitness from admission to discharge in patients undergoing an Autologous Stem Cell Transplant (ASCT) , assessed by the 6 minute walk test as the primary objective and the SF-36 as the secondary objective. All subjects will wear a Fitbit monitor while admitted for the ASCT to record their daily activity.

This study will enroll 20 subjects with a diagnosis of multiple myeloma or lymphoma (10 with each diagnosis) scheduled to undergo ASCT at Cedars-Sinai Medical Center.

After signing the informed consent form, intake data will be collected on all subjects will include age, diagnosis, Karnofsky performance status, and comorbidity index. Subjects will complete an SF-36 questionnaire that assesses their functional and emotional status. Each subject will undergo a 6-minute walk test (6MWT) while wearing a Fitbit monitor to record the number of steps taken. After admission, subjects will be randomly assigned to either the control or intervention group. Subjects in the control arm will receive an activity monitor but the physician, nurse, and patient will not receive any feedback from the device. Patients will be blinded to any data capture from their activity monitor. Participants in the intervention arm will receive an activity monitor and they will receive feedback from the activity tracker and the in-room TV screen. Study participants in this arm will engage with their physicians and nurses around achievement of daily step goals by viewing the in-room TV display of daily step counts on rounds. After discharge, all subjects will again complete the SF-36 questionnaire and perform a 6MWT at a routine clinic visit, within 30 days of the transplant procedure. Descriptive statistics in the form of mean and standard deviation will be used to summarize patient physical activity as measured by 6MWT.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of multiple myeloma or lymphoma with plan to undergo autologous stem cell transplant
* at least 18 years of age
* English or Spanish speaking
* have access to an IOS or Android device
* able to provide informed consent.

Exclusion Criteria:

* pre-existing physical limitations which would preclude achievement of the ambulation goals
* inability to wear the activity monitor
* Jehovah's Witness patients enrolled in the bloodless transplant program are excluded as they require strict bed rest for long periods of time
Calcium Sulfate Spacer in Open Tibia Fractures

Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.


Eligibility Criteria:
Inclusion Criteria:

* Open tibia shaft fracture treated with an IMN

Exclusion Criteria:

* None
Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain

Determine the impact of a laparoscopic-guided transversus abdominis plane (TAP) block timing (at initiation or conclusion of procedure) on the postoperative pain experience in patients following robot assisted laparoscopic radical prostatectomy (RALP).

TAP block involves the use of a local anesthetic agent injected between the internal oblique and transversus abdominis muscles for the goal of pain relief. Often times these are performed under ultrasound guidance by the anesthesiology team preoperatively. The idea behind this is to provide a neurologic block to the sensory nerve fibers supplying the anterior abdominal wall, between the internal oblique and transversus abdominis muscles. More recently, this technique has been investigated in the setting of robot-assisted laparoscopic radical prostatectomy (RALP) with promising results. There is a lack of data comparing the benefits of the timing of TAP block, and whether performing this at the initiation versus conclusion of the case provides superior results

This is a prospective, randomized controlled trial of subjects undergoing early versus late TAP block for the management of postoperative pain following RALP. Subjects will be recruited through physician referral from private Urology offices. Potential subjects (patients scheduled for RALP procedure) will be approached by the study doctor prior to surgery, either in the study doctor's office or in the pre-operative area.

Subjects who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive early or late surgeon performed laparoscopic TAP block. Each patient will only receive one treatment (TAP block) either at the initiation or conclusion of his procedure.

For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone either at the initiation of the procedure (immediately following placement of the robotic / laparoscopic camera port) or at the conclusion of the procedure (immediately proceeding removal of the robotic / laparoscopic camera port). Study doctors will use laparoscopic / robotic camera visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read, understand, and provide written, dated, informed consent prior to screening, complete study form(s) independently, comply with study protocol, and communicate with study personnel about clinically important information.
2. Men ≥ 18 years of age.
3. Pathologically confirmed diagnosis of prostate cancer
4. Scheduled for routine RALP

Exclusion Criteria:

1. Chronic opioid use (daily for \&amp;gt;3 months)
2. Weight \&amp;lt;40 kilograms
3. Any condition that causes a lack of normal sensation to the abdomen or pelvis
4. Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
Statin/Vitamin D & Migraine Study

The investigators are studying if taking simvastatin and vitamin D together will help prevent episodic migraines. Simvastatin is an FDA approved drug that is typically used to treat high cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a vitamin found in certain foods like some types of fish, and in nutritional supplements. This study is 9 months long. Some people who participate will receive simvastatin and vitamin D, and some people will receive a placebo. A placebo is a "sugar pill" that looks like medication but does not have any active ingredients in it.

The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the number of migraines people who have episodic migraine get.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Have had migraines for at least 3 years
* Have between 4 and 15 migraines a month
* Able to speak and read the English language

Exclusion Criteria:

* Women who are pregnant or nursing, or planning on becoming pregnant in the next 10 months
* Individuals who have a had a heart attack, stroke, peripheral artery disease, atherosclerotic aortic disease, carotid artery disease, or diabetes
* individuals at high risk for cardiovascular disease
Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment

The aim of this study is to evaluate the influence of personality profiles in patients with MOH and to evaluate the effect of a custom-made educational programme as an add-on to standard treatment as compared to standard treatment alone in MOH patients using a randomized controlled trial (RCT) design.

Worldwide, two percent of the population suffers from medication-overuse headache (MOH), a paradox condition where the headache is caused by overuse of headache medication. Common treatment is withdrawal, but there is no consensus on what constitutes the best treatment.

The study consists of a RCT with MOH patients randomized to standard treatment versus standard treatment + a 12-week, 6-session educational programme as add-on. The programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups.

Primary endpoint: Headache frequency measured by self-reported headache diary on number of days with headache pre-vious month. Secondary endpoints: NEO-FFI-3 personality test, coping strategies, pain intensity, bothersomeness, patient satis-faction and reported medication intake.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with medication-overuse headache (MOH) by neurologist (The International Classification of headache Disorders).
* Completed withdrawal (hospitalized of 8 days or at home).
* Age 18-65 years
* Understand and speak Danish

Exclusion Criteria:

* Comorbidity (e.g. whiplash, rheumatism which needs analgesic treatment
* Mental health disorders
Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial

Study Objective:

To evaluate the impact of guideline-based CKD comprehensive management medical re-education for community healthcare providers on improving cardio-renal outcomes in CKD patients.

Study Design:

A nationwide, multicenter, prospective, cluster-randomized controlled trial.

Inclusion and Exclusion Criteria:

Inclusion Criteria: Chronic kidney disease (CKD) patients meeting the following criteria:

eGFR \<60 mL/min/1.73 m² or UACR \>30 mg/g on two separate occasions at least 3 months apart.

Exclusion Criteria:

Age \<18 years. End-stage renal disease (ESRD) with eGFR \<15 mL/min/1.73 m², or patients already on regular dialysis or having received a kidney transplant.

Pregnant or breastfeeding women. Patients participating in any other clinical trials. Patients who exhibit characteristics at the screening stage that suggest they are unable to complete the study.

Intervention:

Control Group: Routine community training and management. Intervention Group: Training for community healthcare providers on guideline-based CKD management, including lifestyle management, risk assessment and referral recommendations, risk factor control, pharmacological treatment, and the application of a CKD management checklist incorporating these components.

Efficacy Evaluation Indicators:

Primary Outcome:

A renal composite endpoint, defined as at least a 25% decline in eGFR, progression to ESRD (dialysis, kidney transplantation, or sustained eGFR \<15 mL/min/1.73 m²), or death due to renal or cardiovascular causes.

Secondary Outcomes:

Cardiovascular composite endpoint: cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for heart failure.

Delayed CKD progression, defined as a reduction in the annual eGFR decline rate by 0.5-1 mL/min/1.73 m² or a 30% reduction in UACR per year.

Proportion of patients receiving guideline-recommended pharmacological treatment.

Safety Evaluation Indicators:

Acute deterioration of renal function (serum creatinine increase \>30% within 4 weeks).

New-onset hyperkalemia. Symptomatic hypotension. Recurrent hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

Patients with chronic kidney disease (CKD) (defined as eGFR \<60 ml/min/1.73 m² or UACR \>30 mg/g on two occasions at least 3 months apart).

Exclusion Criteria:

1. Age \<18 years
2. Patients with end-stage renal disease (eGFR \<15 ml/min/1.73 m²) or those already receiving regular dialysis or kidney transplantation
3. Pregnant or breastfeeding women
4. Patients currently participating in any other clinical trial
5. Patients who exhibit characteristics during the screening phase that indicate an inability to complete the study
An Investigation of Different Type Single Limb Exercise Training Effects in Copd

COPD presents not only respiratory symtoms but also vascular or muscle dysfunction. Exercise limitation is observed in COPD. Especially, decreased exercise performance related to vascular and fatique in quadriceps muscle. Exercise training is important for aerobic performance increasing. Generally results show exercise training with both lower limb. Increaed arterial stiffness and fatigue are observed in COPD. One leg exercise training result is not enough to highlight these parameters.

Three types single leg exercise intervantion will be applied. Exercise capacity, muscle strength, lung function, electromyography, lactate and quality of life will be measured.

Three types single leg exercise intervantion will applied to COPD patients that devided three groups. One leg continuous exercise training will be aplied to one group. One leg HIIT exercise training will be aplied to other group. One leg resistance exercise training will be aplied to the last group.

Exercise capacity and muscle strength are assesed. Lung function is measured. Electormyography is recorded. Lactate and quality of life are measured.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients that applied to physiotherapy
* Cooperation for tests
* without severe ortopedical and neurological disease
* without severe cardiovascular disease
* To volunteer for the study.

Exclusion Criteria:

* have an acute exacerbation or having exacerbation at last month
* hypoxemia (PaO2\<55mmHg)
* no cooperated to test without volunteer to study having ortophedical and neurological diesase that affecting of tests severe cardiovascular disease
Clinical and Radiographical Assessment of Patients With Sub-condylar Fracture Using Polyetheretherketone (PEEK) Trapezoidal Plates Versus Titanium Trapezoidal Plates

Some of titanium's drawbacks that is commonly used in maxillofacial surgery included scatter artefacts on regular imaging, implant exposure and inflammation, high thermal conductivity, and high elastic modulus. Very few clinical studies have been published on using a PEEK plate in the mandibular fractures and to the best of the author's knowledge, this is the first study that will be done comparing trapezoidal condylar 3D printed PEEK plates and titanium trapezoidal condylar plate in subcondylar fractures in terms of clinical and radiographical outcomes.

Mandibular subcondylar fractures are common injuries that require treatment to restore function and aesthetic. Titanium plates have long been the gold standard for fixation in these fractures due to their strength, durability, and ability to provide rigid stabilization. However, they are associated with limitations such as a higher elastic modulus than bone, imaging artifacts (e.g., CT or MRI interference), and hardware-related complications. These drawbacks have prompted interest in alternative materials like polyetheretherketone (PEEK).

PEEK is a novel biomaterial with promising properties, including biocompatibility, a modulus of elasticity closer to bone, and reduced imaging artifacts. These characteristics suggest it may mitigate some of the challenges associated with titanium plates. The improved elasticity of PEEK could reduce stress shielding and enhance functional recovery, while its imaging compatibility could simplify postoperative assessments.

Researchers have shown significant interest in the application of PEEK composites in trauma plating systems, total replacement implants, and tissue scaffolds, highlighting its potential as a versatile biomaterial. Despite these advantages, evidence specifically evaluating PEEK trapezoidal plates for subcondylar fractures remains scarce, there are a no clinical studies directly comparing the outcomes of PEEK and titanium trapezoidal plates in terms of clinical outcomes. Conducting a study to evaluate these two materials would provide valuable evidence to guide material selection in mandibular subcondylar fracture management.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older, irrespective of gender
* Recent mandibular subcondylar fractures indicated for open reduction and internal fixation

Exclusion Criteria:

* Medically compromised patients contradicting operation (ASA III, IV \& V).
* Patients receiving radiotherapy or chemotherapy.
* Infection at the fracture line.
* Pathological fractures and old fractures
* comminuted fractures
Chronic Total Occlusion Registry

The aim of this CTO registry is to gather data including patient demographic date, cardiac risk factors, procedural technical data and procedural success/outcome rates. Furthermore, we aim to evaluate the safety and performance of various CTO specific guidewires, devices (such as the CrossBoss/Stingray dissection re-entry device) and other recognised and approved techniques (retrograde wire escalation, retrograde dissection re-entry techniques). The incidence of recognized complications (dissections, perforations, cardiac tamponade, vascular complications, radiation injury, acute kidney injury) will also evaluated. The investigator will assess clinical outcome at 1 year after successful CTO procedures.

This objectives of this single-center CTO registry are to:

1. Gather prospective clinical data on all consecutive patients undergoing complex difficult CTO PCI procedures including patient demographic date, cardiac risk factors, procedural technical data (contrast volume, radiation exposure, procedure time and procedural success/outcome rates.
2. Evaluate the safety and performance of various CTO dedicated guidewires, devices (such as the CrossBoss/Stingray anterior dissection re-entry device) and other recognised and approved techniques (retrograde wire escalation, retrograde dissection re-entry techniques).
3. Evaluate the incidence and severity of recognized complications such as coronary dissections, coronary perforations (+/- need for emergency pericardiocentesis), acute kidney injury, radiation injury, access site vascular complications.
4. Evaluate the medium-term outcome (recurrence of symptoms, major cardiovascular events (cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization) during a routine out-patient consultation (planned as part of normal standard care) at 1 year post successful CTO PCI. After this consultation, the patient may choose to have cardiology follow-up at the UZ Leuven or with his/her referring cardiologist.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients undergoing an elective attempt at percutaneous revascularization of a chronic total occlusion are eligible for inclusion in the CTO registry. A chronic total occlusion is defined as an occluded coronary artery with TIMI 0 flow that has been occluded for 3 months or more. By definition all patients will have been judged to be acceptable candidates for an attempt at revascularization before consenting to be part of the CTO registry.

Exclusion Criteria:

* There are no specific exclusion criteria. If the patient does not wish to consent to having his personal data kept in a registry the patient will not be included in the CTO registry.
Predictive Value of Soluble CD146 in Glioblastoma Patients

Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody bevacizumab in recurrent GBM. However, resistance to this anti-angiogenic reagent is frequent and fails to enhance patients' overall survival. The investigators previously identified one novel mechanism responsible for bevacizumab-resistance in CD146-positive glioblastoma (Joshkon et al. Acta Neuropathol Commun, 2022).

Now, the investigators objective is to prospectively monitor the soluble CD146 value in plasma from patients treated by bevacizumab for recurrent glioblastoma.

The investigators will collect plasma at baseline, before the first bevacizumab administration, before the second administration, at the time of first MRI evaluation and at progression. Plasma CD146 value will be analyzed by ELISA.

The investigators expect to confirm the correlation between soluble CD146 value in plasma and patient response to bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* - Adult patients with recurrent IDHwt glioblastoma
* Relapse after standard first line treatment (radio-chemotherapy)
* Candidate for bevacizumab treatment
* Able to be monitored by MRI
* KPS ≥ 60%
* Written signed consent form

Exclusion Criteria:

* Pregnancy or breast feeding
* Life expectancy less than 3 months
* Bevacizumab in first line treatment
* Other concomitant life-threatening disease
* Under legal protection
Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations

The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.

Objective 1: Evaluate the role of the immune responses in determining the emergence of HCV NS3 resistance mutation during protease inhibitor therapy

Hypothesis 1 (HT 1): Low HLA binding to peptides containing protease inhibitor resistance mutations is associated with the emergence of protease inhibitor mutants during therapy and failure of the treatment.

Hypothesis 2 (HT 2): A hole in T cell repertoire may allow emergence of protease inhibitor mutants during protease inhibitor therapy which leads to loss of the immune responses to these mutants and failure of treatment.

Eligibility Criteria:
Inclusion Criteria: All chronically HCV-infected patients who fail peg-IFN and RBV therapy and are eligible for combined treatment with PI therapy will be enrolled. Briefly, this includes:

1. Male or female
2. Age 18 to 65
3. Chronic HCV infection evidenced by liver biopsy or persistent HCV viremia for \>6 months
4. Treatment experienced and classified as non-responder or relapser to prior interferon-based therapy.

Exclusion criteria:

1. Treatment naïve chronically HCV-infected patients.
2. Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.
3. Pregnancy
4. HIV