cyrilzakka/clinical-trials huggingface dataset:
A Study of MG-K10 in Subjects With Asthma

This study is a phase Ib/II clinical trial conducted in Chinese adult asthmatic subjects to evaluate the preliminary efficacy and safety of MG-K10 humanized monoclonal antibody injection in the treatment of asthma.

The study was conducted in two phases: the Phase Ib study focused on the safety and tolerability of MG-K10 in adult asthma subjects. Phase II study focused on the preliminary efficacy in adults with moderate to severe asthma.

Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosed according to the 2021 version of the GINA guidelines for at least 1 year;
* 1 second forced expiratory volume (FEV1) before randomization before bronchodilator use The measured value is ≤80% of the normal predicted value;
* Must have experienced at least one severe acute asthma attack within 12 months outbreak event.
* Positive bronchodilator test
* Subjects and partners agree to take effective contraceptive measures from signing the Informed Consent Form (ICF) to 6 months after the end of treatment

Exclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function
* Subjects with malignant tumor within 5 years
* Received biologics with the same therapeutic purpose within 6 months prior to screening,
* Women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeeding during the study period;
Physiotherapy Techniques in Adult Neck Pain

To compare the effectiveness of thoracic manipulation and MET on chronic mechanical neckache

it is a randomized control clinical trail to compare the effectiveness of physical exercises for the management of chronical mechanical neckache .so we employed thoracic manipulation for experimental group and MET (muscle energy technique) for control group

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with mechanical neck pain having age group of 18 to 60 years.
* Mechanical neck pain having activities of daily living
* Mechanical Neck pain affecting sleep

Exclusion Criteria:

Patients with following conditions will be excluded

* Osteoporosis
* Radiculopathy
* Pregnancy
* Systemic inflammatory condition
* Neurological deficit
* Arthritic conditions
* Head injuries
The SWEDEGRAFT Right-Heart-Substudy

BACKGROUND

Right ventricular dysfunction is a common echocardiographic finding after cardiac surgery. Pericardial disruption has been suggested as the most probable cause as the phenomenon occurs within minutes after pericardial incision.

The investigators suspect that validated two-dimensional echocardiographic measures for right ventricular function might not reflect the altered RV contraction pattern including paradoxical interventricular septal motion and reduced long-axis function following open cardiac surgery.

The present study aims to determine the prevalence and scale of right ventricular dysfunction two years after CABG by applying the latest available two- and three-dimensional echocardiographic technology in right ventricular evaluation. In addition, the investigators investigate the impact of right ventricular dysfunction on functional outcome.

METHODS

The Right-Heart-Study is an observational substudy of the SWEDEGRAFT trial at Aarhus University Hospital in Denmark. SWEDEGRAFT is a nordic, multicenter, prospective, randomized, register-based, clinical trial (ClinicalTrials.gov Identifier: NCT03501303; Ragnarsson 2020). Patients for the current Right-Heart-Substudy will be recruited amongst the 269 patients included in the SWEDEGRAFT trial at Aarhus University Hospital from 10 September 2018 to 25 May 2020. Patients are enrolled at the time of SWEDEGRAFT follow-up with cardiac-CT (approximately 30 months after CABG). After written informed consent, we perform additional full 2D and 3D echocardiography with special focus on RV function, collect patient-reported data on functional outcome, and measure brain natriuretic peptide and hemoglobin levels.

Complete study protocol attached

Eligibility Criteria:
Inclusion Criteria:

SWEDEGRAFT inclusion criteria:

* First-time non-emergent CABG patients
* Need for at least one vein graft
* Able to provide informed consent and accepted for isolated primary CABG.

Additional inclusion criteria for the Right-Heart-Substudy:

• Ability to meet for follow-up visit

Exclusion Criteria:

SWEDEGRAFT exclusion criteria:

* No greater saphenous vein grafts available (previous vein stripping or poor vein quality)
* Age \> 80 years at the time of inclusion
* Allergy to contrast dye
* Renal failure with eGFR \<15 ml/min at primary inclusion
* Coagulation disorders
* Excessive risk of wound infection
* Participation in other interventional trial on grafts
* Any condition that seriously increases the risk of non-compliance or loss of follow-up
* Pregnant women or women of child bearing potential without negative pregnancy test

Additional inclusion criteria for the Right-Heart-Substudy:

• Inability to cooperate to transthoracic echocardiography
Study of the Effect of General Anesthesia on Children's Behavior

This topic speculates that there is an interaction between family environment and anesthetic drug exposure on children's behavior. Different family environments have different response to anesthetic drug exposure. Children living in a specific family environment may be more susceptible to the effects of anesthetic drugs. People who are susceptible to exposure to narcotic drugs. In order to clarify this hypothesis and discover specific family environment factors that interact with anesthetic drug exposure, this project intends to establish a retrospective cohort study, through hierarchical analysis and other means, to clarify the behavioral changes of children in different family environments after exposure to anesthetic drugs. Provide theoretical support for the safe application of clinical children's anesthetics.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-5 who underwent surgery at Shanghai Ninth People's Hospital
* Current age is less than 18 years old
* No surgical complications such as acute infectious diseases, systemic diseases

Exclusion Criteria:

* History of neonatal hypoxic ischemic encephalopathy and bilirubin encephalopathy
* There are genetic diseases or chromosomal diseases, neurological diseases (including epilepsy, congenital diseases), or a history of head trauma, a history of central nervous system infectious diseases, high fever convulsions, congenital heart disease, tumor diseases, and Patients with blood diseases
* People who have autism, attention deficit hyperactivity disorder, or have received behavioral related treatments and interventions
* Those who have undergone cardiovascular surgery, neurosurgery, or those with unstable hemodynamics during surgery
* Those who cannot be contacted, refused to join the group, the questionnaire information does not match the medical records, or the complete medical records cannot be obtained
POWER (Pulse Width Optimized Waveform Evaluation Trial)

The objective of this study is to compare the ULV (Upper Limit of Vulnerability)/DFT (Defibrillation Threshold) efficacy between the 2.5, 3.5 and 4.5 ms membrane time constant based biphasic defibrillation waveforms. This comparison will result in identifying the optimal membrane time constant when programming the "tuned" defibrillation waveform.

Sudden cardiac death (SCD) continues to be a significant cause of cardiac mortality with annual deaths ranging from 250,000 to 400,000 in the United States. Accordingly, implantable cardioverter-defibrillators (ICD's) have proven to be an important therapeutic option for patients susceptible to SCD. Successful therapy and generator longevity are greatly dependent on proper defibrillation threshold (DFT) determination.

All modern ICD's utilize a biphasic waveform for defibrillation. It has been clearly shown that biphasic waveforms reduce the energy required for internal defibrillation of the heart. However, there is no consensus on which pulse widths are best for defibrillation.

St. Jude Medical ICD's (implantable cardioverter defibrillators) have programmable pulse widths, which allow the physician multiple options in dealing with ICD patients. By implanting ICD's with programmable pulse widths, this study utilizes the Tissue RC Resistance/Capacitance) model to try to identify the optimal pulse widths.

To determine the efficacy of an optimal membrane time constant estimate for the "tuned" waveform, defibrillation testing must be performed. Upper limit of vulnerability (ULV) has been proposed as an alternative means of predicting the DFT and it has been shown that ULV guided DFT testing can achieve a defibrillation success rate of 95%.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a candidate for ICD/CRT-D implantation.
* Patient has a compatible transvenous defibrillation lead system.
* Patient has had an echocardiogram, MUGA, or cath procedure within 6 months of ICD/CRT-D implant.
* Patient is able to tolerate ULV guided DFT testing.

Exclusion Criteria:

* Patient has a mechanical valve in the tricuspid position.
* Patient has epicardial defibrillation electrodes.
* Patient is pregnant.
* Patient is less than 18 years old.
Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant

TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.

LT has evolved rapidly, becoming the standard therapy for acute and chronic liver failure of a variety of aetiologies, with more than 80,000 procedures performed to date \[13\]. HBV infection is a worldwide public health problem, especially in China. The need for an antiviral treatment with NAs for liver transplant recipients has two objectives: the improvement of liver function and to decrease the risk of HBV recurrence after transplant. TAF, TDF and ETV are currently the first-line therapy in patients with CHB in all CHB treatment guidelines, which have a greater potency and higher barriers to resistance. TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be capable of understanding and signing written informed consent; Before commencing the study procedure, participants must obtain informed consent. If the patient is hepatic Coma, the family member shall sign the written informed consent.
* ≥18 years old.
* Orthotopic liver transplant for HBV-related disease (such as HCC, DCC or liver failure). Patients were all positive for HBsAg for at least 6 months prior to liver transplantation.
* HBV DNA ≤ 2000 IU/mL before orthotopic liver transplant . (Including patients who received or did not receive oral antiviral therapy before liver transplantation)

Exclusion Criteria:

* Post OLT patients received HBIG
* Other solid organs transplant recipients
* HCV, HDV or HIV coinfection
* Other primary end-stage liver diseases (PBC, PSC, etc)
* Patients with underwent liver re-transplantation
* Liver grafts from HBsAg+ donors
* Graft dysfunction of any other causes
* HCC with primary portal vein thrombus
A Study Measuring Substances Potentially Indicating Bone Problems in Adults With Type 1 Gaucher Condition

Substances in the body, so-called biomarkers, can help predict the severity of Gaucher disease (GD)-related bone problems in adults. The main aim of the study is to determine if certain biomarkers found in the body at the time of diagnosing GD can help predict the risk of bone problems after 4-5 years.

There is no treatment involved in this study. The study will review previously collected participants' data using a database. Data from both adults with type 1 Gaucher condition as well as healthy adults will be compared.

This is a non-interventional and retrospective study of participants with GD1 and healthy participants whose data is available in the Aragon Health Systems Biobank (BSSA) from the date of diagnosis to 4-5 years after diagnosis. The main objective of this study is to validate the prognosis value of a set of potential biomarkers related to bone disease in participants with GD1.

The study will enroll approximately 120 participants, and it would be divided into 4 groups as given below:

* Group A: GD1 with Low-Normal Bone Disease
* Group B: GD1 with Mild Bone Disease
* Group C: GD1 with Severe Bone Disease
* Group D: Healthy Participants

This study will have a retrospective data collection from the date of diagnosis of GD1 until 4-5 years from diagnosis by using data available in BSSA.

This single-centre trial will be conducted in Spain. The overall time for data collection in this study will be approximately 9 months.

Eligibility Criteria:
For Participants with GD1:

Inclusion Criteria

* Participants with confirmed diagnosis of GD1.
* Determination of Glucocerebrosidase (GCase) blood activity at diagnosis of GD1.
* DNA analysis result demonstrating pathogenic variants in the Glucocerebrosidase gene (GBA1) gene.
* Available data of clinical state at diagnosis and at 4-5 years from diagnosis, including S-MRI, Dual energy x-ray absorptiometry (DXA), and GD1 severity scoring system (GD1-DS3) indexes (or data to calculate it).

Exclusion Criteria

• Evidence of hepatitis B, hepatitis C infection or other chronic infectious diseases.

For Healthy Volunteers

Exclusion Criteria

* Evidence of hepatitis B, hepatitis C infection or other chronic infectious diseases.
* Evidence of bone disease.
Internal Jugular Vein Distensibility in Assessment of Fluid Responsiveness in Donors of Living Donor Liver Transplantation

Egypt has a very high prevalence of HCV and a high morbidity and mortality from chronic liver disease, cirrhosis, and hepatocellular carcinoma. Approximately 20% of Egyptian blood donors are anti-HCV positive. Egypt has higher rates of HCV than neighboring countries as well as other countries in the world with comparable socioeconomic conditions and hygienic standards for invasive medical, dental, or paramedical procedures.

Donor safety is on the top of our priorities as a team and it is widely recognized intraopertively during hepatectomy, there are several potential risks during the Perioperative period .

to a conclusion that intraoperative fluid management aids to the reduction of the intraoperative bleeding during the procedure, adequate and guided fluid management is considered one of the important strategies to reduce the blood loss besides of the other anesthetic techniques like hemodilution, normovolemia, cell salvage usage , high Stroke volume variation (SVV) method ,and low CVP technique , the last method is considered the most applicable, simpler, and cost effective technique which could be easier to be performed.

Eligibility Criteria:
Inclusion Criteria:

* age of 20 years . candidate for donor right lobe hepatectomy for LDLT . volume assessment diagnosed as hypovolemia intraopertively by the anesthesiologist.

Exclusion Criteria:

* inability to scan IJV secondary to surgical dressing, hematoma formation after trial or placement of CVP catheter on left side.

inability for proper positioning.
Epicardial Ablation in Brugada Syndrome. An Extension Study of 500 BrS.Patients

This study represents an extension of a previous study (NCT02641431) on the acute and long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF inducibility in 500 consecutive BrS patients.

According to previous protocol (NCT02641431), 300 additional consecutive selected patients having an ICD implantation will be enrolled up to a total of 500 BrS patients. Echocardiography with cardiac deformation analysis, three-dimensional color-coded voltage, activation and duration electroanatomical maps before and after ajmaline (1mg/kg in 5 minutes) wiil determine the site and the size of the arrhythmogenic substrate as characterized by abnormally prolonged fragmented ventricular potentials and potential wall motion abnormalities. Primary endpoint will be identification and elimination of this electrophysiological substrate by RF applications leading to ECG pattern normalization and VT/VF non-inducibility before and after ajmaline. Patients will be followed up to 10 years after ablation by sequential 12-lead ECG and Holter recording, Echocardiography, ICD interrogation, VT/VF inducibility patterns before and after ajmaline test.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern.

Exclusion Criteria:

* Age \< 18 years, prior epicardial ablation, pregnancy, co-morbidities.
A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment

This multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time compared to the normal infusion time. Patients will be randomized to 8 mg/kg RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, at least 18 years of age, inclusive
* Diagnosis of rheumatoid arthritis of at least 6 months duration
* Moderate to severe active rheumatoid arthritis (DAS28 \>/=3.2)
* Patients received at least 1 disease-modifying anti-rheumatic drug (DMARD) and/or 1 or more TNFalfa-inhibitors over a period of at least 8 weeks

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
* Rheumatic autoimmune disease other than rheumatoid arthritis
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis
* Functional class IV (ACR criteria)
* History of severe allergic reaction to human, humanized or murine monoclonal antibodies
* Known active current or history of recurrent infection (including tuberculosis)
* Primary or secondary immunodeficiency (history of or currently active)
* Body weight \>150 kg
* Previous treatment with any cell-depleting therapies
* Previous treatment with tocilizumab
Phase III Study of KX-826 With Adult Male Patients With AGA

This is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA).

In this study, around 740 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;
2. Male, ≥ 18 old;
3. Clinically diagnosed as androgenetic alopecia;
4. Rating IIIv, IV and V on Hamilton-Norwood scale;

Exclusion Criteria:

1. Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
2. Have used minoxidil within 6 months prior to screening;
3. Have used finasteride or dutasteride within 12 months prior to screening;
4. Had used topical drugs for alopecia sites within 3 months prior to screening;
5. Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;
6. Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.
Using Real-time fMRI Neurofeedback and Motor Imagery to Enhance Motor Timing and Precision in Cerebellar Ataxia

The aim of the research is to improve motor function in people with cerebellar ataxia by using neuroimaging methods and mental imagery to "exercise" motor networks in the brain. The relevance of this research to public health is that results have the potential to reduce motor deficits associated with cerebellar atrophy, thereby enhancing the quality of life and promoting independence.


Eligibility Criteria:
Inclusion Criteria:

* 18-100 years of age
* At least 8th-grade education
* Right-handedness
* Clinical diagnosis of progressive, degenerative cerebellar ataxia by a movement disorder specialist (cerebellar ataxia of unknown etiology, and spinocerebellar ataxias with and without genetic confirmation)

Exclusion Criteria:

* History of Axis I psychiatric disorders (including alcohol and drug dependence)
* Severe or unstable medical disorder, neurological disorders, such as stroke or epilepsy
* History of head injury that resulted in a loss of consciousness greater than 5 minutes and/or neurological sequelae
* Any condition that is contraindicated for the MRI environment (e.g., metal in the body, pacemaker, claustrophobia)
* Currently pregnant
* Clinical diagnosis of multiple system atrophy (MSA) or Friedrich's ataxia (FA)
* Eligible subjects may be asked to refrain from medications that affect the central nervous system that would also make data difficult to interpret (e.g., sedatives) for an appropriate period of time prior to scanning
* Participants will be excluded if the participants do not have a home computer with internet available to complete the 3-week at-home component of the study protocol