cyrilzakka/clinical-trials huggingface dataset:
LIFT Home Study of Non-Invasive ARC Therapy for Spinal Cord Injury

The LIFT Home Study is an observational, single-arm study designed to assess the safety of non-invasive electrical spinal stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity functional deficits in people with chronic tetraplegia.

The primary goal of this study is to report on the safety of the study device when used at home. In addition, the study will report on observed changes in upper extremity function and strength after a period of home use.

The LIFT Home Study will enroll subjects who have recently completed participation in the Up-LIFT Study. The study includes a set of baseline assessments to be completed in the clinic, a four-week home use treatment program prescribed by the investigator, and a final set of clinic-based assessments at the end of the study.

At the baseline visit, the subject and caregiver will be trained on the use of the device and prescribed a specific training regime for its use at home. The subject will be issued a device that is uniquely programmed to operate within a limited set of parameters as specified by the investigator.

Throughout the study, subjects will be prompted to report all adverse events (AE) regardless of relatedness to the device.

At baseline and the final clinic visit, UE strength and function will be measured with stimulation off using a comprehensive set of assessment tools including CUE-T, GRASSP, Pinch and Grasp Force, as well as patient and caregiver global impression of change questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. At least 22 years old and no older than 75 years old at the time of enrollment
2. Non-progressive cervical spinal cord injury from C2-C8 inclusive
3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D
4. Indicated for upper extremity training procedures by subject's treating physician, occupational therapist or physical therapist
5. Minimum 12 months post-injury
6. Capable of providing informed consent
7. Completed the Up-LIFT Study within the prior 12 months

Exclusion Criteria:

1. Has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the Investigator
2. Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations like severe neuropathic pain, depression, mood disorders or other cognitive disorders
3. Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled
4. Requires ventilator support
5. Has an autoimmune etiology of spinal cord dysfunction/injury
6. Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
7. Breakdown in skin area that will come into contact with electrodes
8. Has any active implanted medical device
9. Pregnant, planning to become pregnant or currently breastfeeding
10. Concurrent participation in another drug or device trial that may interfere with this study
11. In the opinion of the investigators, the study is not safe or appropriate for the participant
Impact of Deep Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function

Monocenter randomized controlled trial to compare the effect of deep neuromuscular blockade (NMB) versus moderate NMB during total hip replacement surgery on postoperative quality of recovery and innate immune function.

Rationale: Neuromuscular blockade agents (NMB) may enable surgeons to optimize exposure during hip surgery. With an increasing depth of NMB, manipulation of muscles and adjunctive tissues may be easier, therefore reducing damage to muscles and adjunct tissues. Accumulating evidence exists that the use of deep NMB in laparoscopic surgery is associated with a better quality of recovery and lower pain scores. However, whether this accounts for open surgery is still unknown.

In addition, surgery is associated with postoperative immune suppression. Surgical stress and damage cause the release of Danger Associated Molecular Patterns (DAMPs). After trauma and sepsis, the release of DAMPs is associated with immune paralysis and a higher susceptibility to infectious complications. Previous research indicates that DAMPS are the origin of postoperative immune suppression. The use of deep NMB in hip surgery may reduce surgical damage and thereby lead to a better quality of recovery and secondarily a better preservation of immune cell function.

Primary objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) versus moderate NMB and the quality of recovery after total hip replacement surgery (THR) Secondary objective: To establish the relationship between the use of deep NMB versus moderate NMB and innate immune function after THR surgery

Study design: A monocenter, blinded, randomized controlled clinical trial

Study population: adults who are scheduled for primary or secondary hip replacement surgery under general anaesthesia.

Intervention: Patients will be randomized between a deep NMB (post tetanic count (PTC) 1-2) and moderate NMB (Train-of-four (TOF) 1-2)

Primary endpoint: Quality of Recovery score (QoR-40) at postoperative day 1.

Secondary endpoints: postoperative innate immune function, QoR-40 at postoperative day 30, 30-day postoperative (infectious) complications, postoperative pain scores and opioid consumption

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Scheduled for total hip replacement surgery under general anaesthesia
* Informed consent obtained

Exclusion Criteria:

* Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
* Known or suspected hypersensitivity to rocuronium or sugammadex
* Deficiency of vitamin K dependent clotting factors or coagulopathy
* Severe renal disease (creatinine clearance \<30 ml/min), including patients on dialysis
* Severe liver disease (Child-Pugh Classification C)
* Known or suspected neuromuscular disorders impairing neuromuscular function
* Women who are or may be pregnant or currently breastfeeding
* Chronic use of psychotropic drugs
* Use of immunomodulatory medication
Thailand HDV Cohort

There is very limited data of HDV in Thailand. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. Therefore, this study plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. Findinds from this study will provide the scientific community to understand how important HDV is among HBV patients, this could be used to develop strategies for HDV screening and treatment

The prevalence of HDV remains ill-defined, mainly for lack of appropriate testing and screening. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. This data will inform the guideline whether HDV screening among HBV/HIV is required. This study has plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. This Nationwide survey of HDV is collaboration between Thai liver society, Thai AIDS society, Thai Red Cross AIDS research centre, Faculty of Medicine Chulalongkorn University, and AIDS TB and STI Control Division, Department of Disease control, MOPH Thailand. All findings will be shared and discussed to develop the National guideline for screening, treatment and care.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 18 years and older
2. Chronically-infected with HBV, as defined by:

   Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result
3. Provide signed and dated informed consent form.

Exclusion Criteria:

Non chronic HBV
Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

The aim of the work is to asses the positive effect of stenotic sinus segment stenting on idiopathic intracranial hypertension with headache and papilloedema.

Participants The study will include group of patients with an established diagnosis of idiopathic intracranial hypertenton meeting our inclusion criteria and will admitted to Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria) after informed consent from them. The recruitment will take place after approval from the Ethics Committee and the University Council.

* They are selected according to The modified Dandy Criteria to Diagnose IIH:

  1. Grade II paplledema .
  2. normal neurological examination except for six nerve palsy.
  3. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI.
  4. normal CSF composition.
  5. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults (7).
* Exclusion criteria included:

  1. Age less than orequal to 18 years.
  2. creatinine .1.5 mg/dL.
  3. severe allergic reaction to iodine contrast.
  4. contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome.
  5. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.
  6. pregnancy.
  7. Blood pressure must be measured to exclude malignant hypertension, as defined as a diastolic blood pressure greater than or equal to 120 mm Hg or systolic blood pressure greater than or equal to 180 mm Hg(17).

Eligibility Criteria:
Inclusion Criteria:

* 1. Grade II paplledema . 2. normal neurological examination except for six nerve palsy. 3. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI. 4. normal CSF composition. 5. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults

Exclusion Criteria:

* 1. Age less than to 18 years. 2. creatinine .1.5 mg/dL. 3. severe allergic reaction to iodine contrast. 4.contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome. 5. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow. 6. pregnancy.
the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma

evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* unresectable;
* the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
* sign up consent

Exclusion Criteria:

* cannot tolerate TAI or surgery;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy
Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing

Specific Aim 1 Healthy male and female subjects and growth hormone (GH) deficient subjects display sexually dimorphic GH responses to GHRH administration

Specific Aim 2 GH responses to GHRH in both healthy controls and in GH deficient patients correlate with expression and activity of the stimulatory G proteins, G alpha q and G alpha S. G protein levels correlate with gonadal steroid levels.

Specific Aim 3 Sexually dimorphic GH responses to GHRH are enhanced in Tanner Stage V compared to Tanner Stage 1 individuals

Growth hormone deficiency affects disproportionately more males than females. Although ascertainment bias plays a role in this sexual dimorphism, no plausible mechanism to fully explain this difference has been proposed.

This investigator initiated study will provide currently unavailable data on sexual/age differences in response to GH stimulation testing. Data obtained from the study may provide a basis for developing appropriate normal ranges for adult GH testing, may provide a plausible mechanism for the enhanced hormone responsiveness observed in females, and may provide data on when the sexual differences to GH stimulation may develop.

The objectives of this study are to:

1. Confirm the sexual dimorphism in growth hormone responses for adult growth hormone testing in healthy male and female subjects
2. Correlate peak Growth Hormone Releasing Hormone (GHRH)/arginine induced growth hormone responses with G protein levels in healthy subjects and in patients with a history of childhood GH deficiency
3. Determine whether sexual dimorphism is acquired during puberty

Eligibility Criteria:
Inclusion Criteria:

Healthy subjects

* Males and females, Tanner stage V aged 15-40 years of age with no known endocrine problems
* Males and females, Tanner stage I, aged 5-8 years with no known endocrine problems

GH subjects - Males and females, Tanner stage V, aged 15-21 years with a history of childhood growth hormone deficiency

Exclusion Criteria:

Healthy subjects

* History of GH deficiency or treatment or other known endocrine disorder
* Current height or adult height \<5th %
* Female subjects using hormonal methods of birth control
* Female subjects with irregular menstrual cycles

GH subjects

- Subjects with GH deficiency who have not discontinued GH treatment for at least 2 months
Acute Tendon and Nerve Responses to Exercise

The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit training on the upper extremity of persons with spinal cord injury and able-bodied controls.

Background: Manual wheelchair propulsion is a primary source of mobility for many individuals with spinal cord injury (SCI). Propelling a manual wheelchair over an extended period often leads to arm pain and, subsequently, to secondary disability. Over 50% of manual wheelchair users with SCI experience arm pain that limits their activities of daily living. The prevalence of shoulder pain and carpal tunnel syndrome among manual wheelchair users is between 31% and 73%, and 49% and 73% respectively. A circuit training protocol has been developed to strengthen and protect the muscles of people with SCI, and has been shown to improve muscle strength and endurance, and reduce HDLcholesterol levels.

Purpose: The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit training on the upper extremity of persons with SCI and able-bodied controls.

Hypotheses: All subjects will show an increase in nerve cross-sectional area after participation in the circuit training protocol. Nerves and tendons will become less echogenic after participation in the circuit training protocol. These changes will be more pronounced in persons with SCI.

Methods: Data collected will include history of pain, a physical exam, and ultrasound images of the nondominant upper extremity before and after a bout of circuit training, which includes exercises lifting weights and using an arm cycle. Before circuit training, ultrasound images will be collected once. After the circuit training, ultrasound images will be collected every 10 minutes over an hour. These images and will be used to measure the health and properties (such as size) of nerves, muscles, and tendons in the arm. Changes in these properties after a bout of circuit training will be related to history and physical exam information.

Eligibility Criteria:
Inclusion Criteria:

Spinal Cord Injury Cohort:

* any cause or severity of spinal cord injury
* at least 1 year post-injury

Able-Bodied Control Cohort:

* self-reported good health

Exclusion Criteria:

* history of non-dominant traumatic upper extremity injury to both wrist and shoulder
* history of cardiopulmonary or other disease for which intense activity carries any risk of harm
* a progressive or degenerative disability
The Effectiveness of Kinesio Taping in Violin Players

This study aimed to investigate the effectiveness of Kinesio taping (KT) on playing-related pain, upper extremity and hand function, grip and pinch strength in violin players. One hundred seventeen participants who were professional violinists for at least two years were randomized to receive either therapeutic tape application (KT group), a sham tape application (placebo group) or no application (control group) for one week. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) in one week. The secondary outcomes were the Visual Analogue Scale (VAS), the Purdue Pegboard Test, grip and pinch strength. Outcome measures were performed at baseline, immediately after the intervention, and one week later (follow-up). Participants were asked to play the "Violin Concerto No.2, Op.35", and pre-and post-performance pain and grip and pinch strength were assessed.

Kinesio tape (KT), an alternative taping technique, is a method consisting of a tape with elastic properties and stretching capabilities used to treat pain or prevent injuries in conjunction with exercise.It has been concluded that KT intervention might not be helpful to reduce dystonic patterns or improve playing ability in musicians with focal hand dystonia. However, there is no enough study to conclude the effectiveness of KT application in Playing-related musculoskeletal disorders. Therefore, this study aimed to investigate the effect of KT on playing-related pain, upper extremity and hand function, grip and pinch strength in violin players compared to placebo KT application and control. As a secondary outcome, the investigators explored whether the pre-and post-performance effect of the KT on playing-related pain and grip and pinch strength.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 18 and 35 years;
2. professionally playing violin at least for two years;
3. having playing-related musculoskeletal pain at neck and upper extremity \[Visual Analogue Scale (VAS) ≥3\]
4. ability to read and write in Turkish; and
5. able to follow simple instructions.

Exclusion Criteria:

1. having significant musculoskeletal, neurologic, or cardiovascular disorders;
2. a history of surgery on the upper limbs in the previous six months;
3. the initiation of any analgesic intervention for musculoskeletal pain within the previous six weeks;
4. known allergies to tape; and
5. participation in physiotherapy and rehabilitation program in the last six months.
The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia

The aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia.

Percent change Homa insulin resistance, cholesterol and triglycerol.

Eligibility Criteria:
Inclusion Criteria:

* Age 20--69 years old
* Type 2 diabetes for \> one year
* TG \>= 150 mg/dl or LDL \>= 100 mg/dl

Exclusion Criteria:

* GPT \> 80 mg/dl
* Creatinine \> 1.8 mg/dl
* Pregnancy
* AMI
* Stroke
* Operational or any not suitable patients diagnosis physician in charge
Study of ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors

A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors


Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
2. Patients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor treatment;
3. At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
4. Organ functions meet the clinical criteria

Exclusion Criteria:

1. Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.
2. Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.
3. Patient with recent anti-tumor and other treatment as stated in the protocol.
4. Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
5. Other conditions considered unsuitable for participation in this trial at the discretion of the investigator
DApagliflozin Cardiovascular Effects on Patients at End-stage REnal Disease

Treatment with sodium glucose co-transporter type 2 inhibitors (Sglt2i) reduced the incidence of cardiovascular death and hospitalization for heart failure by 29% in individuals with moderate chronic kidney disease. Recent observations found that beyond its effect on natriuresis, Sglt2i directly interacts with cardiomyocytes inducing improvement of myocardial function. This effect is not mitigated as glomerular filtration rate declines. Therefore, plausibly treatment with Sglt2i may attenuate heart failure in individuals end-stage kidney disease (ESKD) requiring dialysis, in whom cardiovascular disease remains the leading cause of death.

In this context, this project was designed to estimate the effect of dapagliflozin on myocardial function of dialysis subjects. Individuals with diagnosed ESKD on dialysis for at least 3 months, from both sexes, aged more than 18 years of age are eligible. Exclusion criteria are pregnant woman, hepatic failure, and known allergy to study medications. Eligible patients will be recruited from the Nephrology Division of the Clinics Hospital of the University of Campinas (Unicamp). The study was designed as a prospective, randomized, open-label, phase 4 clinical trial. Patients will be randomized, 1:1, for a 6-months treatment with either dapagliflozin 10mg/day (n=40) add to standard treatment or standard treatment alone (n=40). At the randomization visit, all patients will undergo a detailed interview and medical examination by the physician-researcher, echocardiogram and blood samples will be collected for further biochemical analysis and follow up visits will be scheduled every month for endpoints disclosure and medications dispensation until the end of study participation at the 6th month visit when echocardiogram and blood sample collection will be repeated.

Primary goal will be the difference between groups in mean change of NTproBNP levels during treatment. Secondary endpoints encompass the mean change in ejection fraction, e/e' ratio, global longitudinal and radial strain and indexed left ventricle mass. Changes in bone metabolsm and structure, assessed by serum levels of FGF-23 and α-Klotho, and changes in bone mineral density will be compared between groups as an exploratory analysis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* On regular dialysis regimen for at least 3 months

Exclusion Criteria:

* Known allergy to any of the investigational drug components
* Current use of sodium-glucose co-transporter 2 inhibitors
* Pregnant woman
* Myocardial infarction or myocardial revascularization in the past 3 months