cyrilzakka/clinical-trials huggingface dataset:
Suprascapular Nerve Block Efficacy for Shoulder Surgery

This study evaluates the analgesia induced by suprascapular nerve block in comparison to interscalene nerve block in arthroscopic rotator cuff repairs. The experimental and the control group will receive the suprascapular nerve block and interscalene nerve block, respectively.

Peripheral nerve blocks are widely used for postsurgical analgesia. Interscalene nerve block provides a total brachial plexus motor and sensitive blockade while the suprascapular nerve block produces only a specific peripheral blockade.

The interscalene nerve block is the most frequently used anesthesia technique and requires a longer learning curve. Complications related to this technique may be more severe and frequent in comparison to other regional anesthesia techniques.

The suprascapular nerve block yields less adverse effects, discomfort and rebound effect as this technique does not completely block the upper limb motor function.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old
* Confirmed rotator cuff tear by magnetic resonance imaging

Exclusion Criteria:

* Irreparable cuff tears (retracted lesions to the glenoid rim and/or fourth grade fatty infiltration)
* Partial repair of cuff tears (immobile lesions)
* Rheumatic diseases
* Neck-related shoulder pain
* Glenohumeral instability or osteoarthritis
Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans

Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation.

Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation. Patients are recruited from the waiting list for islet transplantation within The Nordic Network for Clinical Islet Transplantation. Patients included in the study will undergo apheresis while on the waiting list. T regulatory cells will be sorted out and frozen. Autologous, non modified T regs will then be infused simultaneously intraportally with the islet graft at transplantation. Patients will be followed for safety and efficacy regarding the islet transplantation over three months

Eligibility Criteria:
Inclusion Criteria:

* Patient must be registered on the waiting list within The Nordic Network for Clinical Islet Transplantation
* Type 1 diabetes with diagnosed \<40years of age and with\>5 years of exogenous insulin use
* C peptide \< 0.1 nmol/L at MMTT if no previous islet transplant
* Adequate previous treatment by an experienced diabetologist
* Patient must understand and be able to sign an informed consent

Exclusion Criteria:

* Patient with a previous transplant other than islets
* Patient with an BMI\>30
* Patient with an need of more than 1U/kg of insulin per 24h
* Repeated abnormal liver function tests
* non stable retinopathy
* known abnormalities in coagulation
* known malignancies
* non stable heart conditions
* active infections
* serological proof of hepatitis B or C or HIV
* signs of portal hypertension
* patients that are pregnant, breast feeding or aim to become pregnant during the study period
* patients with a PRA \> 20%, positive cross match or known DSA
* patients with conditions that the investigator would consider unsafe to combine with islet transplantation
Open Label Immunotherapy Trial for Ovarian Cancer

This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumors of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.

Ovarian cancer (OC) - a malignant disease affecting the ovarian tissue - is the sixth most diagnosed cancer among women and causes more deaths than any other cancer of the female reproductive system. For treatment of OC, surgical intervention, chemotherapy, as well as radiation methods are used. Despite treatment, about 70% of patients have a relapse. Many different types of immunotherapy (especially checkpoint inhibitors) of OC being tested, but so far the successes have been insignificant, and serious side effects are frequent and unpredictable. This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

Confirmed diagnosis of ovarian cancer Positive for CA125 tumor marker at above normal threshold level -

Exclusion Criteria:

Metastases to other sites

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Myocardial Blood Volume Measurement by Real-Time Myocardial Perfusion Echocardiography Correlates to Myocardial Compressibility by Cardiac Magnetic Resonance Imaging in Healthy Subjects

This study is being done to find out the normal amount of blood within the heart muscle and the variations in this blood flow between a cardiac MRI and TTE.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Available for testing performed in Rochester, MN.
* Willing to undergo both an echocardiogram with RTMPE and CMR.
* Study subject providing consent.

Exclusion Criteria:

* Adults \< 18 years.
* BMI \<30 kg/m\^2.
* Hypertension.
* Diabetes Mellitus.
* Stroke.
* Cardiomyopathy or structural heart disease.
* Known coronary artery disease or history of myocardial infarction.
* Contraindication to echo enhancement agent or gadolinium administration such as an allergy.
* Renal GFR \< 50 mL/mL.
* Females who are pregnant.
* Subject unwilling to consent.
Plasma Triglyceride Lipolysis in Multifactorial Chylomicronemia

Purpose: The mechanism of most of the multifactorial chylomicronemia (MCM) remains elusive. In order to decipher the mechanisms involved in the occurrence of this disease, plasma TG lipolysis characteristics will be monitored for 60 minutes after heparin injection instead of the 10 minutes gold standard, in a large group of genotyped MCM patients.

Purpose: The mechanism of most of the multifactorial chylomicronemia (MCM) remains elusive. In order to decipher the mechanisms involved in the occurrence of this disease, plasma TG lipolysis characteristics will be monitored for 60 minutes after heparin injection instead of the 10 minutes gold standard, in a large group of genotyped MCM patients.

Method: LPL, APOC2, APOA5, GPIHB1and APOE genotypes will be determined for each patient. Basal lipid profiles including Apo B, CII, CIII, and lipoprotein lipase (LPL) concentration will be measured in 62 MCM patients, in addition to LPL activity (PHLA) T0, T10 T30 T60 minutes, Assessment of TG chylomicron decrease Study of lipoprotein remodelling by agarose gel electrophoresis.

Hypothesis To confirm the preliminary finding of high LPL activity in multifactorial chylomicronemia To explore the interest of a longer assessment of LPL activity following heparin injection. To establish if specific phenotypes could be identified among MCM patient supporting the hypothesis of different mechanisms involved (ie overproduction or defect in hepatic clearance)

Eligibility Criteria:
Inclusion Criteria:

* patient with a documented history of MCM (Plasma TG concentration (TG) \> 15 mmol/l or familial history of hypertriglyceridemia with TG \>10 mmol/l)
* no contraindication for a single heparin injection for ex vivo LPL activity assessment

Exclusion Criteria:

* patients carriers of homozygous or compound heterozygous mutations on LPL, GPIHBP1, APOA5, APOC2 or APOE genes
Comparative Study Between Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children

PURPOSE: The study aims to compare study between Botulinum toxin-A injection and shock waves therapy on hypertrophic scars in hand-burned children.

BACKGROUND: Burn injuries can cause significant physical and psychological distress, especially when they result in hypertrophic scarring. In children, who are particularly vulnerable to these injuries, it is important to accurately assess the severity of these scars and their impact on functionality.

HYPOTHESES: There is no significant difference between the combined effect of the traditional physical therapy program with botulinum toxin-A injection and the traditional physical therapy program with shock waves therapy on improving wrist extension, ulnar deviation, radial deviation, hand grip strength, and severity of the scar on hypertrophic scars in hand-burned children.


Eligibility Criteria:
Inclusion Criteria:

* Age will range from 6-18 years
* Diagnosed with hypertrophic scars resulting from hand burns.
* Has burn injuries caused by flame, scald or chemical agents.
* With a total body surface area (TBSA) varied from 10 to 30%
* A resistant partial or complete loss of wrist flexion attributable to wrist flexor contracture
* After wound and skin graft healing (\~ 90 days post-surgery),

Exclusion criteria:

* Children with underlying medical conditions that could interfere with scar healing or treatment outcomes
* Skin flap surgery, malignancies, cardiac arrhythmias, pacemaker implantation, coagulopathies, fractures about the treatment area, articular adhesions, and psychiatric co-morbidities
A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant

The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.

This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.

Eligibility Criteria:
Inclusion Criteria:

* Subject is skeletally mature
* Subject has one or more of the following diagnoses:

  1. Degenerative Disc Disease (DDD) at one level or two contiguous levels from L2 to S1

     a. DDD may include up to Grade 1 spondylolisthesis at the involved level(s)
  2. Degenerative Scoliosis for which the interbody fusion device will be used as an adjunct to fusion
* Subject has received 6 months of non-operative therapy
* Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent
* Subject agrees to comply with visit schedule and study assessments
* Provision of signed and dated informed consent form
* Subject stated willingness to comply with all study procedures and availability for the duration of the study
* Subject is in good general health as evidenced by medical history

Exclusion Criteria:

* Subject is obese (BMI \> 40)
* Subject is sensitive to titanium materials
* Subject has an active infection at the operative site
* Subject has marked local inflammation
* Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, tumors involving the spine, active infection at the site, or certain metabolic disorders affecting osteogenesis
* Subject has any mental, trauma, or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care
* Subject has any open wounds
* Subject is pregnant or plans to become pregnant during the course of the study
* Subject has inadequate tissue coverage over the operative site.
* Subject has an neuromuscular deficit which places an unsafe load on the device during the healing period
* Subject has any condition of senility, mental illness, or substance abuse
* Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count.
* Subject has prior fusion at the levels to be treated
* Subject is incarcerated
Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment in Ethiopia

Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is. This study will provide evidence to help clinicians make the best choice regarding treatment for complicated cutaneous leishmaniasis (CL) cases. Due to diversity in host-pathogen interactions across the different CL forms, early immunological correlates associated with treatment responsiveness and unresponsiveness could help treatment recommendation and provide us with the basis to develop new diagnostic and treatment strategies.

This study aims to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using SSG and Allopurinol combination within a routine care setting located in a highly endemic area in Ethiopia.

Cutaneous Leishmaniasis (CL) in Ethiopia causes severe dermatological mutilations. Forms that require systemic treatment are complicated localized cutaneous leishmaniasis (cLCL), mucocutaneous leishmaniasis (MCL), and diffuse cutaneous leishmaniasis (DCL). The clinical presentation of CL depends on various factors including parasite species, infection history and differences in the immune response. National guidelines recommend equally all drugs that are also used for visceral leishmaniasis treatment. Sodium stibogluconate (SSG) is one of these recommended medications. However, dermatologists in Ethiopia also use a combination of SSG and Allopurinol for treatment of complicated cutaneous leishmaniasis.

Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is. This study will provide evidence to help clinicians make the best choice regarding treatment for complicated CL cases. Due to diversity in host-pathogen interactions across the different CL forms, early immunological correlates associated with treatment responsiveness and unresponsiveness could help treatment recommendation and provide us with the basis to develop new diagnostic and treatment strategies.

This study aims to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using SSG and Allopurinol combination within a routine care setting located in a highly endemic area in Ethiopia.

Eligibility Criteria:
Inclusion Criteria:

* Clinically or microscopically confirmed diagnosis of MCL, DCL or complicated LCL
* Clinical routine care decision to initiate systemic CL treatment using SSG with allopurinol
* Willing and able to provide informed consent

Exclusion Criteria:

* Medical emergencies, underlying chronic conditions or other circumstances that make participation in this study medically or otherwise inadvisable

Study sample collection only for Age 18 and above
Natural Killer (NK) Cell Therapy for B-Cell Malignancies

This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma.

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL. Up to 22-36 patients will be enrolled.

This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma.

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 24-36 patients will be enrolled.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of B-cell lymphoma or B-ALL as described below:

B-cell Lymphoma:

* Histologically documented lymphomas expected to express CD19 and CD20
* Relapsed/refractory disease following at least two prior systemic treatment regimens, or relapsed after the autologous hematopoietic stem cell transplantation (HSCT)

B-ALL:

* Diagnosis of B-ALL that expected to express CD19
* Relapsed/refractory disease following prior systemic treatment regimens

ALL SUBJECTS:

* Provision of signed and dated informed consent form (ICF)
* Age ≥ 18 years old
* Stated willingness to comply with study procedures and duration
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate organ function as defined in the protocol
* Donor specific antibody (DSA) to QN-019a: MFI \<= 2000
* At least 3 weeks after the last systemic immunochemotherapy treatment
* The estimated survival days are expected to be over 3 months

Key Exclusion Criteria:

ALL SUBJECTS:

* Females who are pregnant or lactating
* Evidence of insufficient organ function as defined in the protocol
* ECOG Performance Status ≥2
* Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T/CAR-NK within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
* Currently receiving or likely to require systemic immunosuppressive therapy
* Known active central nervous system (CNS) involvement by malignancy. Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease
* Clinically significant cardiovascular disease as defined in the protocol
* Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* Donor specific antibody (DSA) to QN-019a: MFI \> 2000
* Other comorbid conditions and concomitant medications prohibited as per study protocol
* Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients

This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who is older than 18.
2. Patient who is HBsAg positive for the previous 6 months and with HBV DNA ≥ 1 x 10\^5 copies/mL
3. Patient who is HBeAg negative.
4. Patient with ALT≥1×ULN.
5. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Patient is treated with interferon for the previous 6 months.
3. Patient has been treated previously with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient has evidence of ascites, variceal hemorrhage and/or hepatic encephalopathy.
6. Patient has evidence of decompensated Liver cirrhosis and/or hepatocellular carcinoma.
7. Patient has a history of organ transplantation.
8. Patient has the treatment of nephrotoxicity drugs, competitive drugs for kidney to excrete, and/or hepatotoxicity drugs for the previous 2 months from screening.
9. Patient is pregnant or breast-feeding.
10. Patient has a clinically relevant history of abuse of alcohol or drugs.
11. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
12. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Effects of Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of ASCVD

Despite older adults being exposed to an increased risk of atherosclerotic cardiovascular disease (ASCVD), they are generally underrepresented in cardiovascular prevention programmes. The aim of this study is to assess the feasibility of implementing an integrated exercise and cardiovascular health education programme (HE programme) on older adults at risk of ASCVD.

The study is a two-arm pilot randomized controlled trial. (1) The control group will receive a basic lifestyle modification talk and governmental education leaflets. (2) The experimental group will receive an integrated exercise and health education programme (HE programme) based on self-efficacy theory. Physical activity level, exercise self-efficacy and ASCVD risk profile including blood pressure, cardiac endurance, and anthropometric outcomes will be investigated via physiological assessments, medical history-taking or questionnaires at baseline, Week 6, and Week 12. Meanwhile, study feasibility will be primarily evaluated in terms of programme acceptability, intervention integrity, recruitment rate and retention rate throughout the process and at Week 12.

Eligibility Criteria:
Inclusion Criteria:

* Chinese adults ≧60 years old
* Having at least one ASCVD risk factor
* Pass the cardiovascular fitness evaluation
* Able to write and read Chinese, and communicate in Cantonese;
* Possess a mobile phone and able to make use of the phone in reading SMS

Exclusion Criteria:

* Visually impaired, hearing impaired, or suffer from cognitive, psychiatric, or muscular disorder
* Having a history of attending similar cardiovascular prevention program
* Having a previous history of coronary heart disease or stroke