cyrilzakka/clinical-trials huggingface dataset:
Impact Of Physiotherapy And Botox In Improving Functional Outcomes Among Post Stroke Focal Dystonia Patients

This study was conducted to assess the combine role of Physiotherapy by providing task specific trainings and Botulinum Toxin Type A in improving the functional outcomes of upper limb in post stroke patients with focal hand dystonia.

Post-stroke hemiparesis, with dystonia, is a major cause of disability. Dystonia can hinder the functional activities making patient dependent on others for performance of daily living activities. Dystonia not only limits the physical activity of the patient but also affects their quality of life significantly. Various treatment protocols have been used in the literature for treatment of focal hand dystonia in the past including deep brain stimulation, kinesio taping, sensory oriented training, splinting, extracorporeal shock wave therapy and botox. Out of these Botox has gained much importance but it results only in improving the passive range of motion and has no consensus in improving the active range of motion and functional independence of the patient. The current study was planned to determine the effects of botulinum toxin type A combined with task-specific therapy, for post-stroke focal dystonia of upper limb.

Eligibility Criteria:
Inclusion Criteria:

* Patients having first episode of unilateral stroke
* At least 6 months of post stroke duration presenting with post stroke focal dystonia of the upper limb.
* No previous exposure of the affected hand of Botox.
* Reduced upper limb functions
* Both genders will be included equally.

Exclusion Criteria:

* Significant speech or cognitive impairment which impedes the ability to perform the assessment.
* Other significant upper limb impairment e.g. fracture or frozen shoulder within 6 months.
* Severe arthritis, amputation, evidence of fixed contracture, pregnancy or lactating womens.
* Other diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. blind, malignancy,
* Other conditions which may contribute to upper limb spasticity, e.g. multiple sclerosis, cerebral palsy.
* Use of botulinum toxin to the upper limb in the previous 4 months.
* Contraindications to intramuscular injection.
* Contraindications /allergy to botulinum toxin type A, which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides.
Oxygen Level and Safe Emergence From Anesthesia

Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the postoperative area of atelectasis without desaturations becoming more common.


Eligibility Criteria:
Inclusion Criteria:

* No sign of difficult airway or intubation
* Day case surgery in total intravenous anesthesia with laryngeal mask airway without adding regional anesthesia of plexus brachialis or muscle relaxant.
* Body mass index less than 35.
* American Society of Anesthesiologists physical status (ASA) class I-III

Exclusion Criteria:

* Body mass index 35 or higher
* Increased risk of aspiration
* Obstructive sleep apnea syndrome
* Procedures during surgery making a former easy airway a difficult airway
* Need for opioids after extubation
* Hypothermia
Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

This is a biomedical, single-center, and prospective study of a consecutive patients cohort in acute ischemic stroke with carotid plaque.

The main objective of this study is to evaluate the prevalence of the contrast taking carotid plaques in these acute ischemic strokes.

The secondary objectives are:

* to determine the clinical, sonographic, CT scanner and MRI characteristics of patients in constituted acute cerebral ischemia with carotid atherosclerotic plaque taking contrast to the doppler ultrasound.
* to explore of the plaque contrast enhancement at 6 months (new injection).

Eligibility Criteria:
Inclusion Criteria:

* All patients aged at least 18 years hospitalized with ischemic stroke signs in the carotid territory, objectified on brain MRI with positive DWI.
* Carotid plaque \> 2.5 mm thickness in the ipsilateral carotid territory to the AIC, low echogenicity (Type 1, 2, 3, and 4a of the classification Geroulakos) measured by the assessment "GSM" (median gray level).
* Free and informed consent patient or his representative for contrast injection microbubble.
* Affiliated to health insurance.

Exclusion Criteria:

* Severe cerebral infarction with NIHSS\> 25
* No-indications to the contrast medium injection
* Recent myocardial infarction, unstable angina.
* Heart failure stage III / IV New York Heart Association.
* Cardiac shunt left-right, respiratory distress.
* Allergy to albumin or contrast agents.
* Carotid plaques and hyperechoic calcified (however these plaques will be counted to determine their prevalence in acute AIC).
* Carotid dissection
Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT

A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies

A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies.

Duration of study: 60 weeks

Eligibility Criteria:
Inclusion criteria for patients:

1. Patients with a diagnosis of rheumatic or immune-mediated diseases eg. SLE, RA, PSA, SpA, inflammatory myopathies, ANCA-related and large vessel vasculitides
2. Age ≥18 years
3. Stable or reducing doses of any the following immunosuppressive regimens within 4 weeks of study entry:

   1. Prednisolone ≥20mg/kg/day ± mycophenolate mofetil, azathioprine or the calcineurin inhibitors
   2. Cyclophosphamide (intravenous pulses or daily oral)
   3. B-cell depleting biological agents and their biosimilars eg. belimumab, anti-CD20 agents (next scheduled dose should be arranged to at least 12 weeks after study entry for rituximab or obinutuzumab)
   4. Anti-TNFα biological agents and their biosimilars eg. infliximab, etanercept, adalimumab, golimumab, certolizumab
   5. Anti-interleukin-6 biological agents eg. tocilizumab, sarilumab
   6. Other biological agents eg. abatacept, ustekinumab, secukinumab, ixekizumab
   7. The JAK inhibitors eg. tofacitinib, baricitinib, upadacitinib
4. Female patients with reproductive potential are allowed to participate in this study provided that they are willing to practice contraception for until at least 12 months after vaccination
5. Willing to comply with all study procedures

Exclusion criteria for patients:

1. Active infection, including upper respiratory tract infection
2. Active HZ infection
3. Active untreated tuberculosis
4. HIV infection
5. History of HZ or varicella vaccination in the past
6. History of allergy to any vaccines
7. Patients who are pregnant or plan to become pregnancy within one year of study entry
8. Lactating women
9. Patients who cannot give a written consent (mentally incapable or illiterate)
Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.

Various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2. Routine treatment of the patients will be continued as per the Institute protocol. These patients will be assessed for the liver transplant free survival at 28 days and complications \[PHT related bleed, AKI, infections, HE\] within 90 days; transplant-free survival rate at 90 days; evolution of the AARC score for 2 wk.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of ACLF (APASL criteria) - jaundice (serum bilirubin ≥ 5 mg/dL and coagulopathy (INR ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis,
2. Age 18-70 yrs
3. Baseline HVPG ≥ 12 mmHg.

Exclusion Criteria:

1. Contraindications to NSBB (heart rate \< 65 /min, BP \< 110/65 mm Hg, asthma, heart failure),
2. Portal Vein Thrombosis,
3. Hepatocellular carcinoma,
4. HVOTO,
5. HE grades 2-4,
6. NSBB therapy within 5 days,
7. Pregnancy,
8. Lactation,
9. Planned for LT in the next 12 weeks
10. No consent.
Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit

Critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (ICU)-acquired weakness, which are associated with mortality and other poor outcomes. Early physical rehabilitation has shown benefit in ICU settings, but has not been studied in ICU patients with acute and chronic liver failure. Cycle ergometry, or stationary cycling in passive and active modes, may be especially beneficial to such patients due to their high prevalence of severe physical deconditioning and variable mentation. The aim of this study is to examine the feasibility, safety, and benefit of cycle ergometry over standard physical and occupational therapy (PT/OT) in critically-ill patients who have acute or chronic liver disease.

A single-blinded randomized controlled trial will be conducted in a transplant intensive care unit (TICU). Eligible adult patients will be enrolled within 72 hrs after TICU admission and randomly allocated to either (1) standard PT/OT care, or (2) PT/OT care and cycle ergometry sessions with trained PT/OT therapists or technicians. The outcome measures, tests of strength and function, will be assessed at baseline, every 14 days, and upon TICU discharge by a blinded PT/OT therapist.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 ≥ years with acute or chronic liver disease admitted to Transplant Intensive Care Unit (TICU), or admitted to TICU following a liver or liver-kidney transplant
* Expected to remain in ICU for ≥ 5 days
* Spoken English fluency

Exclusion Criteria:

* Known primary systemic neuromuscular disease or intracranial process causing increased intracranial pressure
* Lower extremity amputation
* Anticipated death or palliative withdrawal of life support within 5 days
* Cycle ergometer weight limit (135 kg or 297.6 lbs per manufacturer)
FIRST - Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy

The purpose of the study is to assess the impact of first and subsequent cycle pegfilgrastim on neutropenia events (such as hospitalizations, dose reductions and delays) in patients receiving myelosuppressive chemotherapy.


Eligibility Criteria:
Inclusion Criteria: - Pathologically confirmed diagnosis of the following malignancies: breast, non-Hodgkin's lymphoma (NHL), Hodgkin's disease, ovarian, colorectal, lung or other - Planned administration of a new myelosuppressive every 14 (q14), q21, or q28 day chemotherapy - Written informed consent for participation in the study before any study-specific procedures are performed, including screening and registration Exclusion Criteria: - Planned concomitant therapeutic radiation - Diagnosis of acute or chronic leukemia or myelodysplastic syndrome - Prior stem-cell transplantation (includes bone-marrow transplantation) - Medical diagnosis of chronic neutropenia of any cause not related to cancer - Current cytotoxic, biologic, or immunologic therapy for unrelated conditions - Subject has active infection requiring treatment - Known HIV-positive subjects - Subject of child-bearing potential is evidently pregnant (e.g., positive HCG test) or is breast feeding - Subject of child-bearing potential is not using adequate contraceptive precautions - Known sensitivity to E. coli derived drug products (e.g., filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® growth hormone, INTRON A®) - Any psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with study protocol procedures - Subject is currently enrolled in, or has not yet completed at least 30 days since ending another device or drug trial(s) or is receiving, or plans to receive, other investigational agent(s) not approved by the Food and Drug Administration (FDA)
First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.

Phase 1 clinical trial

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 50 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Willing and able to comply with the requirement for using the recommended highly effective contraceptive methods throughout the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* History of febrile illness within 5 days prior to the first dose.
* A positive urine drug screen
Development and Application of Molecular Evaluation Instrument for Lung Cancer Diagnosis and Treatment

The precise diagnosis and treatment of lung cancer is not only a major national strategic need but also an urgent demand from the general public. The "three stages" of precise diagnosis and treatment of lung cancer include early diagnosis, effective treatment, and precise evaluation. Currently, invasive methods are mainly used in these three stages of clinical practice. The non-invasive molecular diagnosis of early-stage lung cancer and the molecular evaluation of treatment efficacy are critical core issues in lung cancer clinical diagnosis and treatment. In response to this problem, this project aims to use exhaled breath as a sample to develop a scientific instrument with independent intellectual property rights, which integrates early-stage diagnosis of lung cancer and evaluation of treatment efficacy. We will also conduct related application research to meet the needs of the public and contribute to the health of the entire population.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in the clinical study; fully understand and be informed about this study, and sign the informed consent form (ICF); willing to comply with and have the ability to complete all trial procedures.
2. Male or female participants aged 18-75 (inclusive) at the time of signing the ICF.
3. The case group included patients diagnosed with lung cancer, including early-stage and advanced-stage patients; the control group consisted of healthy individuals without a history of lung cancer or related respiratory diseases.
4. At least one measurable target lesion evaluated according to RECIST 1.1 criteria by the Institutional Review and Research Committee (IRRC).
5. Patients provide eligible tumor tissue for histopathological testing as required.
6. Relevant laboratory tests indicate tolerance to chemotherapy and immunotherapy.

Exclusion Criteria:

1. Patients with unclear diagnosis of lung cancer.
2. Patients with contraindications to chemotherapy or immunotherapy.
3. Patients with contraindications to lung tissue examination.
4. Patients with other respiratory diseases within the year or concurrent respiratory system diseases (such as chronic obstructive pulmonary disease, bronchial asthma, etc.).
5. Patients with other active malignant tumors within the year or concurrently.
6. Patients with severe heart disease and patients with other severe diseases (such as liver dysfunction, renal dysfunction, etc.).
7. Patients known to have a history of psychiatric drug abuse or drug addiction; patients with a history of alcohol abuse.
8. Based on the investigator's judgment, patients have other factors that may lead to premature termination of this study.
Medical Mistrust Among Hispanic/Latino Gay, Bisexual and Other Men Who Have Sex With Men (HLMSM)

There is an urgent need to address HIV inequities and disparities in the US, particularly within vulnerable communities such as Hispanic/Latino gay, bisexual, and other men who have sex with men (HLMSM).

Medical mistrust is associated with HIV disparities among HLMSM because mistrust may result in delayed or reduced use of needed HIV prevention (e.g., HIV testing and Pre-exposure prophylaxis (PrEP) uptake) and care (e.g., AntiretroViral Therapy \[ART\]) services.

While advances have been made to increase the use of HIV prevention and care services, profound disparities persist, and a need remains for increased understanding of the multilevel drivers of medical mistrust and for effective interventions to address these drivers among HLMSM in the US.

This research proposes a mixed-method study that includes rigorous qualitative and quantitative methods to better understand the drivers of medical mistrust among Spanish-speaking, English-speaking, and bilingual (including Spanish and English, or an indigenous language and Spanish and/or English) HLMSM. This study also proposes to refine and test a multilevel intervention designed to address medical mistrust and increase the use of needed HIV prevention and care services among diverse HLMSM in Mecklenburg County, NC, a jurisdiction prioritized by the Ending the HIV Epidemic in the US (EHE) initiative.

Eligibility Criteria:
Inclusion Criteria:

* reside in Mecklenburg County, NC
* identify as Hispanic/Latino
* be ≥18 years of age
* speak English and Spanish
* report identifying as male and having had sex with at least 1 man in the past 6 months
* provide informed consent

Exclusion Criteria:

* less than 18 years of age
* female
Tiotropium / Respimat One-Year Study

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.


Eligibility Criteria:
Criteria

* Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study. Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.
Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome

The study aims to compare the differences of ocular surface features in controls and patients with diabetes and dry eye syndrome, to thoroughly evaluate the ocular surface health of diabetics, and to find out the relationship between dry eye syndrome and diabetes

In this study, we perform a completely comparison of ocular surface characteristic including the Ocular Surface Disease Index (OSDI) questionnaire,tearfilm break up time(BUT),corneal fluorescein scores(CFS),Shirmer test,corneal sensitivity)among diabetic patients with DE, diabetic patients without DE, non-diabetic patients with DE and normal subjects and analysis of EGF, IL-17A, IL-1β, IL-8 and TNF-α in tears and their clinical correlations are also performed to investigate potential biomarkers for diagnosis of diabetic with DE.

Eligibility Criteria:
Inclusion Criteria:

1. dry eye diagnosis according to Expert's Consensus About Clinical Diagnosis and Treatment（Corneal Disease Group of Ophthalmological Society, Chinese Medical Association）: ①OSDI≥13，②positive dry eye soigns(ST≤10mm/5min；BUT≤10s；CFS\>0)
2. type 2 diabetes diagnosis according to American Diabetes Association：Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)
3. Willing to sign the consent form.

Exclusion Criteria:

1. Having known Eye infection, allergy, malformation, abnormal eye movement
2. Exclusion of eye injury, any kind of eye surgery
3. Exclusion of other disease may cause neuropathy or influence tear producing
4. Using systematic or local antibiotics that may influence tear producing

Elimianation Criteria

1. poor compliance
2. voluntary withdrawal
3. any other kind of situation that researchers consider not suitable for further study.
Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy

To investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with rising PSA following radical prostatectomy, to produce a sustained biochemical response during the first 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* who are 18 years of age or older.
* who have undergone radical prostatectomy within 2 years prior to PSA progression .
* exhibiting two consecutive rises in PSA levels relative to a previous reference value, separated by 14 days.

The first measurement must occur 14 days after the reference value und must be at least 20% above the reference value. The reference value must be at least 0.4 ng/ml. The second confirmatory measurement taken 14 days after the first measurement must be greater than the first measurement.

* with a Karnofsky Performance Score (KPS) greater than or equal to 90 (Appendix 5).
* with the following hematologic lab values: ANC greater than or equal to 1500/mm3, Hgb greater than or equal to 10g/dL, PLT greater than or equal to 100x109/L.
* with the following biochemistry lab values: total bilirubin \< 1.5 ULN, SGOT, SGPT less than or equal to 2.5 ULN, serum creatinine less than or equal to 1.5 ULN.
* willing to employ an effective barrier method of contraception during the study duration and for 3 months following discontinuation of study drug (for patients of reproductive potential).
* with a life expectancy of \> 6 months.
* who have provided written informed consent pursuant to local regulatory requirements prior to initiation of any study procedure.

with a Gleason Score \> 6 in the prostatectomy specimen

Exclusion Criteria:

* with a history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer, unless written approval is obtained by the sponsor.
* with prior hormonal therapy
* who require therapy with warfarin or analgesics of the morphine class or higher (see Section 3.4.4).
* with a known diagnosis of HIV, hepatitis B, or hepatitis C infection.
* who have had a major surgery within 2 weeks prior to study entry.
* with severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including severe cardiac insufficiency (NYHA III or IV, see Appendix 2), uncontrolled diabetes, chronic hepatic or renal disease, and active uncontrolled infection.
* with a history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.

Other protocol-defined inclusion/exclusion criteria may apply