cyrilzakka/clinical-trials huggingface dataset:
Neuroprotective Effects of iTBS in PD

Intermittent theta burst stimulation (iTBS) is an emerging non-invasive neuron regulation technique, which is widely used in neuropsychiatry for a variety of diseases and is widely accepted by patients due to its non-invasive, operable and relatively precise localization. Combining the results of previous studies and our group's previous research, sixty qualified PD patients would be enrolled to conduct a prospective single-center randomized double-blind sham controlled clinical trial to verify the long-term curative effects of iTBS treatment protocol and explore the neuron-protection of iTBS on neuronal loss of PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Meet the revised clinical diagnostic criteria for Parkinson's disease of the Movement Disorder Society (MDS) International (2015 version).
* aged \>20 years and \<80 years, regardless of gender.
* 2 ≤ Hoehn-Yahr stage≤ 4.
* Maintain medication stability during the study period.
* Good compliance, written informed consent, and consent for long-term interventional treatment with iTBS.

Exclusion Criteria:

* Patients with severe neuropsychiatric disorders or previous history of severe neurological disorders (e.g., epilepsy, cerebrovascular accidents, etc.) or history of traumatic brain injury or brain surgery.
* Patients with significant cognitive impairment (MMSE \< 24) or inability to complete questionnaires independently.
* Prior treatment with TMS, DBS or SCS.
* Severe physical illness and any physical illness that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory disease.
* Have human implantable materials such as intracranial stents, pacemakers, coronary stents, cochlear implants, etc.
* Are currently taking other investigational drugs.
* Any other condition that the investigator deems unsuitable for participation in this study.
Radioablation With or Without Androgen DeprIvation Therapy in Metachronous Prostate Cancer OligometaStAsis

A randomized phase II clinical trial (RADIOSA trial: Radioablation with or without Androgen DeprIvation therapy in metachronous prostate cancer OligometaStAsis).

The aim is to compare time to progression between the two study arms: SBRT only or SBRT and hormonotherapy (ADT). The primary objective is to compare the progression-free survival (PFS) defined as the absence of new metastatic lesions (local, regional or distant) between the two arms. The secondary endpoints include the comparison of overall survival (OS), biochemical progression-free survival (BPFS), ADT-free survival, local control, treatment-induced acute and late toxicity, time to castration-resistant disease and QoL between the two arms; the development of a dedicated biobanking (collection of plasma and serum) for further biological investigation of predictive/diagnostic factors for personalized treatment; the preliminary evaluation of prognostic biomarkers; the correlation between imaging-derived parameters and treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven initial diagnosis of adenocarcinoma of the prostate;
* Biochemical relapse of PCa following radical local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant/salvage radiotherapy) +/- ADT according to the European Association of Urology (EAU) guidelines 2016 \[18\] or after any salvage therapy if biochemical progression is diagnosed in the context of castration sensitive PCa;
* Nodal relapse in the pelvis, extra-regional nodal relapse (M1a), bone metastases (M1b) on Ch-PET/CT or WBMRI with a maximum of 3 lesions;
* Serum testosterone level \>50 ng/dl at the time of randomization (castration sensitive PCa)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* Age ≥18 years;
* Written informed consent signed

Exclusion criteria

* Serious concomitant comorbidities or contraindication to SBRT and/or ADT;
* Previous invasive cancer (within 3 years before the prostate cancer diagnosis) apart from non-melanoma skin malignancies;
* No ability to complete questionnaires about QoL;
* Presence of mental diseases that cannot ensure valid informed consent;
Cardiovascular Comorbidity in Children With Chronic Kidney Disease

This 3-year study will systematically evaluate the prevalence, clinical symptoms, and progression of CV and kidney disease and assess the impact of potential genetic, pharmacological, behavior, and environmental risk factors in a prospective cohort with a sample size of 125 aged 3-18 years children with stage G1-G4 chronic kidney disease (CKD). Measurements of morphological (e.g., LVMI \& cIMT) and functional characteristics (e.g., FMD \& PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA \& urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.

Taiwan has the highest incidence and prevalence rates of end-stage renal disease all over the world. Chronic kidney disease (CKD) becomes a global public health burden, which can begin in earliest childhood. CKD in childhood differs from that in adults. Congenital anomalies of the kidney and urinary tract (CAKUT) is the leading cause of childhood CKD. Children with CKD due to CAKUT have the highest risk of having a genomic imbalance. Thus, early identification of genotype-phenotype correlations to develop novel therapeutic approaches might reduce the heavy burden of CKD for the future of Taiwan.

Study design:

1. A 3-year prospective cohort study.
2. Sample size: 125 children and adolescents with stage G1-G4 CKD, age 3 to 18 yr, and 30 controls.

4. Measurement: Measurements of morphological (e.g., LVMI \& cIMT) and functional characteristics (e.g., FMD \& PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA \& urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents with stage G1-G4 CKD

Exclusion Criteria:

* current pregnancy
* inability to complete major data collection
* kidney transplant
* cancer
An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer

This observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants with newly diagnosed mCRC who have started first-line capecitabine-based chemotherapy in accordance with the current Hungarian label

Exclusion Criteria:

* History of serious or unexpected reaction to fluoropyrimidine therapy
* Hypersensitivity to the active ingredient of Xeloda or to any of the excipients of the product, or to fluorouracil
* Known dihydropyrimidine dehydrogenase deficiency
* Pregnancy or lactation
* Inadequate bone marrow, hepatic or renal function
* Treatment with sorivudine or its chemical analogues (for example, brivudine)
* If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used
Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome

This randomized controlled trial aims to evaluate the effects of Mobilization with Movement (MWM) on pain, function, and quality of life in patients with Thoracic Outlet Syndrome (TOS) compared to conventional physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-65 years, diagnosed with TOS by a specialist, and experiencing symptoms for at least 3 months

Exclusion Criteria:

* Previous surgery for TOS
* contraindications to manual therapy
* other comorbidities significantly affecting upper limb function
Clinical Analysis of Juvenile Dermatomyositis Patients

This study aimed to investigate the clinical effectivity of intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil in the treatment of newly diagnosed juvenile dermatomyositis.

Reviewed the clinical data of 12 juvenile dermatomyositis patients, from January 2014 to January 2017, hospitalized and treated with intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil

Eligibility Criteria:
Inclusion Criteria:

1. patients with age of JDM onset \<16 years
2. newly treated cases
3. no contraindications to corticosteroids
4. provide signed informed consent form
5. regular follow-up for more than 30 months.

Exclusion Criteria:

1. patients with serious complications of heart, liver and kidney
2. patients with a history of contraindications and/or allergies to GC
3. patients who underwent treatment before admission
4. patients who failed to regularly follow-up
5. patients with positive anti-melanoma differentiation-associated gene 5 (MDA5) antibodies
Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot Study

The ELECTRA pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet inhibition in stable patients who recently underwent acute myocardial infarction and were treated with percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* provision of informed consent prior to any study specific procedures
* diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction according to the Third Universal Definition of Myocardial Infarction
* index event treatment with percutaneous coronary intervention
* male or non-pregnant female, aged 18-80 years old

Exclusion Criteria:

* contraindications for ticagrelor
* further coronary revascularization planned during the first 45 days after myocardial infarction
* indications for chronic treatment with oral anticoagulant or low-molecular-weight heparin
* active bleeding
* history of intracranial hemorrhage
* recent gastrointestinal bleeding (within 30 days)
* history of coagulation disorders
* history of moderate or severe hepatic impairment
* history of major surgery or severe trauma (within 3 months)
* active neoplastic disease
* patient requiring dialysis
* chronic inflammatory disease
* current therapy with strong CYP3A inhibitors or strong CYP3A inducers
Fox BioNet Project: ECV-003

The goal of this study is to optimize pre-analytical cerebrospinal fluid (CSF) extracellular vesicle isolation protocols for increasing the detection of LRRK2 activity in human CSF

Specific aims to accomplish this objective are:

PRIMARY OBJECTIVES:

* To evaluate a series of extracellular vesicle isolation methods for their ability to enrich for LRRK2 and increase the detection of LRRK2 in CSF samples.
* To compare the measurements of LRRK2, p1292 LRRK2, Rabs and pRabs from the ECVs isolated using each method.
* To assess the inter-lab reliability of each method

SECONDARY OBJECTIVES

* To assess the ability of the network of sites to efficiently conduct a study involving biosample collection for PD research. Efficiency will be assessed using measures of the time taken to meet specific milestones within the study
* To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon protocols.
* To gauge the willingness of participants to participate in subsequent Fox BioNet studies

Eligibility Criteria:
Inclusion Criteria:

Parkinson's Disease Patients:

* A diagnosis of Parkinson's disease in the opinion of the enrolling investigator
* Disease duration: any
* Male or female age 18 years or older at time of PD diagnosis.

Healthy Controls:

•Male or female age 18 years or older at Screening.

Exclusion Criteria:

Parkinson's Disease Patients:

* Inability to provide informed consent
* Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
* Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.

Healthy Controls:

* Inability to provide informed consent
* Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
* Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.
* Currently pregnant (female participants)
Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain

The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.


Eligibility Criteria:
Inclusion Criteria:

* Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain.
* Leg pain score ≥ 6 cm (Visual Analog Scale \[VAS\]).
* Back pain score ≥ 6 cm (VAS).
* Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits.
* Subject is not pregnant and not \<18 years of age.

Exclusion Criteria:

* N/A
The Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function

To determine the effect of (1) increased sodium intake and (2) increased potassium intake on blood pressure, vascular function and renal function in untreated (pre)hypertensive subjects.

This is a randomized, double-blind, placebo controlled cross-over feeding study.

Eligibility Criteria:
Inclusion Criteria:

* (Pre)hypertension, defined as office SBP: 130-159 mmHg;
* No use of antihypertensive, lipid-lowering, anticoagulant or other cardiovascular medication;
* Age at start of the ≥ 40 years;
* Apparently healthy:

  * No reported current or previous metabolic diseases
  * No history of cardiovascular diseases
  * No history of renal, liver or thyroid diseases
  * No history of gastrointestinal diseases
  * No diabetes mellitus
  * Fasting laboratory parameters within normal range: renal function (serum creatinine, ureum), liver function (ALAT, ASAT, ɣ-GT) and serum glucose.

Exclusion Criteria:

* Body mass index \> 40 kg/m²;
* Smoking
* Secondary hypertension;
* Weight loss or weight gain of 5 kg or more during the last 2 months;
* Usage of non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, naproxen) and not able or willing to stop taking them from at least 4 weeks prior to the study.
* Medical treatment that may affect blood pressure and not able (or willing) to stop taking them;
* Women taking oral contraceptives or estrogen replacement therapy
* Taking nutritional supplements and unwilling to discontinue;
* Women lactating, pregnant or intend to become pregnant during study;
* Reported dietary habits: medically prescribed diet, slimming diet;
* Reported alcohol consumption \> 21 units/w (female subjects) or \>28 units/w (male subjects);
* Unable or unwilling to consume one meal every workday at the university, or to consume the prescribed study diet for 13 weeks;
* Problems with consuming the supplements or following the study guidelines;
* Unwilling to undergo home or office blood pressure measurements;
* Recent blood donation i.e. 1 month (male subjects) or 2 months (female subjects) prior to the study and planned donation during the study period;
* Reported intense sporting activities \> 10 h/w;
* Not agreeing to be informed about unexpected and medically relevant personal test-results
* Participation in another biomedical trial less than 2 months before the start of the study or at the same time;
* No informed consent signed.
Distal Radius Fracture Prospective Database 50-80 Years Old

The Problem Distal radius fractures (DRF) are common and result in a variable amount of disability. The investigators have completed considerable work in developing tools that measure impairment and disability after DRF . The investigators initial studies indicate that the associated disablement process is multifactorial and variable with only 25% of the resultant disability predicted by baseline patient and injury characteristics. The investigators see DRF as a signal event where some people are at-risk of transitioning from an active lifestyle to inactivity and subsequent health risks. The investigators recent data confirms variable participation following a DRF. The traditional focus in orthopedic/rehabilitative approaches to DRF fracture management has been localized to the wrist, largely ignoring this potential transition and its health impacts. The investigators will initiate a line of investigation that will profile the at-risk older adult who presents with a DRF with the ultimate goal of accurate identification and prevention of adverse activity transitions (active to inactive). In this study the investigators will identify the extent of the problem by quantifying changes in activity/participation and its short-term health impacts. The investigators will also identify the risk factors present at time of injury that predict a loss of mobility/activity/participation. This work has the potential to identify tools and/or clinical prediction rules that identify at-risk individuals at a critical time where early intervention might most easily prevent adverse outcomes associated with inactivity.


Eligibility Criteria:
Inclusion Criteria:

individuals 50-80 years old

* one month of fracture resulting from a fall from standing height or less will be recruited through our orthopedic surgeon
* wrist fracture

Exclusion Criteria:

previous history of humeral, hip or vertebral fracture

• Testing will not be performed on patients with evident postural instability, severe chronic conditions (Parkinson's disease) or other vestibulo-ocular abnormalities.
Comparison of Different Inspiratory to Expiratory Ratios on Respiratory Mechanics and Oxygenation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult male patients (20-90 years of age) scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia

Exclusion Criteria:

* Patients with an abnormal airway anatomy, reactive airway diseases, chronic respiratory diseases, a history of coronary artery diseases, or heart failure
* BMI \> 30 kg/m 2
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.

Abuse Liability Study

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects.
* Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year before Screening Visit, and at least once in 8 weeks before the Screening Visit.

Exclusion Criteria:

* Diagnosis of substance and/or alcohol dependence.
* Subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder.
* History of sleep apnea.
* Positive urine drug screen (UDS) for other that marijuana.
* Positive for Hepatitis B or C and HIV on Screening.
Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women


Eligibility Criteria:
Inclusion Criteria:

* Lactating females, ≥ 18.0 years of age, at the time of enrollment
* Willingness to limit the baby's exposure to hydroxyurea through breastmilk, such as healthy volunteers using the "pump and dump" technique or avoiding direct breastfeeding or collection of pumped milk for at least 8 hours after taking the hydroxyurea dose. This applies only to healthy controls or women with sickle cell who are not already taking hydroxyurea. Women with sickle cell already taking hydroxyurea may continue to breastfeed their infants.

Exclusion Criteria:

* Persons with known allergies to hydroxyurea
* Failure to sign informed consent, or inability to undergo informed consent process
* Persons for whom it is not feasible or medically advisable to obtain the specimens necessary for this study
The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy

The Whipple operation is a complex surgical procedure involving the removal of the head of the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for patients who have cancer or some other condition affecting this region of the body. The Whipple operation is associated with a significant complication rate. Previous studies have shown that in a broad range of surgical procedures, using a reduced amount of intravenous fluids along with a special type of fluid called hypertonic saline during and after the procedure can lower complication rates associated with the heart and lungs during recovery from surgery. The purpose of this study is to determine if using a reduced amount of intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous fluids) during the Whipple operation and in the immediate period after surgery can reduce complications.


Eligibility Criteria:
Inclusion Criteria:

* Physiologic suitability for major abdominal surgery
* Aged 18 years and older
* Written informed consent
* Ability to understand and comply with study guidelines
* Ability to obtain a central venous line

Exclusion Criteria:

* Metabolic acidosis
* Active Sepsis or Bacteremia
* Chronic renal insufficiency
* Hyponatremia (serum sodium \<130)
* Hypernatremia (serum sodium \>150)
* Pregnancy
* Sickle cell anemia
* Pediatric patients
* BMI\>40