cyrilzakka/clinical-trials huggingface dataset:
Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer

This study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of HER2-positive early breast cancer


Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥18 years and ≤75 years who are newly treated for breast cancer;
2. Pathological examination confirmed HER2 positive (immunohistochemical staining ICH+++ or ICH++ and FISH positive);
3. Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
4. ECOG score 0-1;
5. Plan to undergo the final surgical removal of breast cancer, i.e. breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);
6. If the major organs function normally, the following criteria are met:

(1) The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: TBIL≤ upper limit of normal value (ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized, they should consent to abstinence or use an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment.

8. Volunteer to join the study and sign the informed consent.

Exclusion Criteria:

1. Known allergic history of the drug components of this protocol;
2. Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
3. Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
4. Stage IV (metastatic) breast cancer patients;
5. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
6. Serious heart disease or discomfort that cannot be treated;
7. Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
8. Pregnant or lactating women;
9. Patients with severe liver and kidney function diseases and blood system diseases;
10. Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Poor compliance and refusal to cooperate with treatment
The Feasibility of Telehealth HEP for CP (HEP: Home Exercise Program), (CP: Cerebral Palsy)

This study will provide exercise videos and live consultation sessions for adolescents with spastic cerebral palsy. We will recruit 20 participants with 10-18 years old and will be randomized into an experimental or control group. The experimental group will receive exercises videos 2 times a week and one time live consultation session for 8 weeks.

The Control group will receive exercise videos 3 times a week for 8 weeks. Both groups will use HIPAA compliant telehealth provider (Physitrack website/ app).


Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with spastic CP diagnosis, Gross Motor Functional Classification System (GMFCS) levels I-III) which will be confirmed by GMFCS-Extended Revised.
* Between the ages of 11 and 18 years old.
* Having a stable health status for 6 weeks prior to screening.
* Having the cognitive ability to follow an exercise instruction in either written or electronic format, with or without support from their parents.
* With an approval from parents/guardians for participating in this study.
* Having access to the internet at home and access to the exercise's website/app via Personal computer (PC), laptop, or mobile app.
* Being able to understand and follow verbal commands in English. The intervention and the questionnaires are available in English only.

Exclusion Criteria:

Subjects will be excluded if they have:

* unstable medical condition during past 6 weeks,
* had other neurological disorders that may cause further decline in balance and walking abilities (head injury, vestibular dysfunction, or Spinal cord injury),
* or any musculoskeletal condition that would interfere with the safe performance of the exercise intervention or testing protocol,
* scheduled surgical operations or castings during study period,
* scheduled for intensive rehabilitation during 8 weeks of intervention.
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

Eligibility Criteria:
Inclusion Criteria:

* COVID 19 positive patients

Exclusion Criteria:

* COVID-19 patients with critical manifestations.
* Sepsis.
* Acute respiratory distress syndrome (ARDS).
* Decompensated liver disease (Child-Pugh class B or C disease).
* Chronic renal impairment.
* Patients with blood diseases (severe anemia, thalassemia, ITP, leukemia ....).
* Ischemic heart disease within the last 6 months.
* Chronic pulmonary disease.
* Malignancy.
* Pregnancy or breastfeeding.
* Hypersensitivity to sofosbuvir or ribavirin.
* Patients with organ transplant.
* Unwilling to participate in our study
LCH in Adults: a Collaborative, Prospective-retrospective, Observational Study

This is a multicenter, retrospective and prospective, observational, no profit study including adult patients with LCH, diagnosed starting from January 2001 to two years after the first enrolled patient. Each patient will be followed up to one year after the last enrolled patient. Each patient will be followed up to one year after the last enrolled patient.This study plans to collect clinical information at the time of diagnosis and at various follow-ups to evaluate the efficacy of first-line therapies. Diagnostic and therapeutic data will be collected from routine clinical evaluations and laboratory and instrumental investigations carried out during clinical practice

This is a multicenter, retrospective and prospective, observational, no profit study including adult patients with LCH, diagnosed starting from January 2001 to two years after the first enrolled patient. Data from patients, diagnosed from January 2001 to the date of patient enrolment, is considered retrospective, while data collected after patient enrolment, and up to two years after the first enrolled patient, is considered prospective. At least one year of follow-up is expected for each patient. Each patient will be followed up to one year after the last enrolled patient. This study plans to collect clinical information at the time of diagnosis and at various follow-ups to evaluate the efficacy of first-line therapies. Diagnostic and therapeutic data will be collected from routine clinical evaluations and laboratory and instrumental investigations carried out during clinical practice. A sub-cohort of patients with available biological data on somatic mutations of the RAF-MEK-ERK genes will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed histological and immunohistochemical diagnosis of LCH (CD1a+, S-100+, CD207+), from January 2001 up to two years after the first enrolled patient. Patients with isolated vertebra plana, not related to a malignancy, and without a soft tissue component, are included without a histological and immunohistochemical diagnosis;
* Age ≥18 years at the time of definitive diagnosis;
* Signed, written informed consent, according to ICH/EU/GCP, and national, local laws.

Exclusion Criteria:

* Age ≥18 years and presumptive diagnosis of LCH, or definitive diagnosis of non-Langerhans Histiocytosis (Juvenile xantogranuloma, Rosai-Dorfman disease, Erdheim-Chester disease, etc.).
Diabetes Visual Function Supplement Study

This study will evaluate the effects of a novel multi-component dietary supplement on the visual function and retinal structure of patients with diabetes with both no diabetic retinopathy and mild to moderate diabetic retinopathy. This is a placebo-controlled trial and neither subjects nor examiners will know if any given subject is taking active supplement or placebo.

The hypothesis is that the supplement will improve visual function and retinal structure in subjects on active supplement

Adult patients with either type 1 or type 2 diabetes will be enrolled with baseline measurement of visual acuity, contrast sensitivity, color vision, threshold macular perimetry, macular pigment optical density, optical coherence tomography, glycosylated hemoglobin, blood lipids and serum vitamin D status. A multi-component dietary supplement containing ingredients currently available over the counter in the US will be taken for six months and repeat measurements of the above parameters obtained.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus diagnosed at least 5 years
* age greater than or equal to 18 years
* English speaker

Exclusion Criteria:

* proliferative diabetic retinopathy or severe non-proliferative retinopathy
* clinically significant macular edema
* corrected visual acuity less than 20/30 in either eye
* diagnosis of other serious eye disease (glaucoma, age-related maculopathy)
* less than 18 years old
* non-English speaker
* no known allergy or sensitivity to any supplement ingredients
Pharmacokinetics, Pharmacodynamics, and Impact of Inorganic Nitrate on Exercise in HFpEF

This study will be performed to determine the safety, tolerability, and dose-response to inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study:

1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely given to subjects with HFpEF.
2. Determine if there is a dose-response effect of nitrate supplementation on exercise capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations to exercise.

This study randomized subjects to either placebo (n=3) or KNO3 (n=9) given a sequential dosing regimen: 6 mmol twice daily for 1 week followed by dose escalation to 6 mmol thrice daily for 1 week). Although a primary goal of the study was to assess the safety of KNO3 and within-group changes in various end points in KNO3-treated subjects, a small number of placebo-treated (PB, n=3) subjects were included only to assess for any potential training effect on repeated exercise and Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements. Potassium chloride, given in equivalent doses, was used as the PB to account for differences in blood pressure or flow that could be attributed to potassium.

The study was initially designed to be single-blinded to allow the principal investigator to be aware of arm allocation because of potential concerns for methemoglobinemia with drug administration. One investigator, who was the primary investigator responsible for supervising all visits and measurements during the study, remained blinded to treatment allocation throughout the entirety of the study. All physiological and imaging data were analyzed in a double-blind manner.

Eligibility Criteria:
Inclusion Criteria:

1. NYHA Class II-III symptoms.
2. LV EF \> 50%.
3. Stable medical therapy for at least 1 month.
4. Evidence of significant diastolic dysfunction, meeting the European Society of Echocardiography criteria for HFpEF.

Exclusion Criteria

1. Any rhythm other than sinus with native conduction.
2. Inability to exercise.
3. Moderate or greater valvular disease.
4. Hypertrophic, infiltrative, or inflammatory cardiomyopathy.
5. Pericardial disease.
6. Current angina.
7. Acute coronary syndrome or coronary intervention within the past 2 months.
8. Primary pulmonary arteriopathy.
9. Clinically significant lung disease.
10. Ischemia on stress testing without subsequent revascularization.
11. Treatment with phosphodiesterase inhibitors that cannot be withheld.
12. Treatment with organic nitrates or allopurinol.
13. Significant liver disease impacting synthetic function or volume control.
14. Poor echocardiographic windows.
15. eGFR \< 30 mL/min/m2 or Cr \>2.5.
16. Current smoking.
17. Alcohol dependency.
18. History of Barret's esophagus.
19. G6PD deficiency
20. Methemoglobinemia - baseline methemoglobin level \>3% prior to any study medication.
Comparison Between the Effect of Ultrasound Debridement and Conventional Treatment in Diabetic Foot Ulcers (DFU).

The investigators aimed to elucidate the effects of ultrasound debridement on the area and healing of diabetic foot ulcers compared to their conventional treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥18 years old.
* Type 1 or type 2 diabetes mellitus with HbA1c ≤ 10%.
* DFU grades IA, IIA, IB, IIB, IC, IIC, ID, IID, according to the University of Texas Classification.
* DFU grades PEDIS 1-Absence of Infection, PEDIS 2-Mild infection and PEDIS 3-Moderate infection, according to the PEDIS-IDSA Classification.
* Wound size between 1 cm² and 30 cm².
* Evolution time DFU between 1 and 24 months.
* Ankle-brachial index (ABI) ≤0.9 and ankle systolic blood pressure (ASBP) ≥70mmHg, or toe systolic blood pressure (TSBP) ≥50mmHg, ABI\>0.9, TSBP ≥50mmHg and toe-brachial index (TBI) ≤0.7

Exclusion Criteria:

* Critical limb ischemia patients with ABI≤0.5 and ASBP\<70mmHg or TSBP\<50mmHg.
* Clinical suspicion of osteomyelitis.
* Pregnant or lactating women or women of childbearing potential who are not using effective contraception.
* Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)
Long-term Safety and Tolerability of BHV-7000

A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303.
* (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit

Key Exclusion Criteria:

* Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
* Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained.
2. Subject randomized within 24 hr of completion of transplant surgery.
3. Recipient of a kidney with a cold ischemia time \< 30 hours.
4. Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.

Exclusion Criteria:

1. Subject unable to tolerate oral medication at time of randomization.
2. Use of other investigational drugs at the time of enrollment.
3. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
4. Multi-organ transplant recipient.
5. Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
6. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA.
7. Subject who is HIV-positive.
8. HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels ≥ 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable.
9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).
10. Subject with a BMI greater than 35.
11. Subject with severe systemic infections, current or within the two weeks prior to randomization.
12. Subject requiring systemic anticoagulation.
13. History of malignancy of any organ system.
14. Subject with severe restrictive or obstructive pulmonary disorders.
15. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
16. Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3.
17. Pregnant or nursing (lactating) women.
18. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Effectiveness Intraarticular Corticosteroid

The purpose of this study is to compare the small and large dose of corticosteroid used in intraarticular injection of wrist.

Background / Objectives: The optimal dose of corticosteroid to be used in intraarticular injection is not well established. The objective of this study is to compare the effectiveness and tolerance in the medium-term between small and large dose of triamcinolone hexacetonide (TH) used in intraarticular injection (IAI) of medium size joint of patients with rheumatoid arthritis (RA). Materials/Methods: A controlled, randomized, prospective, double-blind study will be realized in patients with RA. It will be evaluated 60 wrists joints (representing medium size joints) from the outpatient clinics at the Rheumatology Division UNIFESP, Brazil. Inclusion criteria were: patients with established RA, age between 18 and 65 years, disease modifying anti-rheumatic drugs (DMARDs) stable for at least 3 months, synovitis in wrist with pain visual analogic scale (VAS) between 4 and 8cm. Patients with overlap syndromes, polyarticular synovitis, diabetes mellitus or uncontrolled hypertension and those with suspected local or systemic infection were excluded. Patients will be randomized (Clapboard randomization) in two groups of 30 patients each: group 1 (high dose) is injected with 40mg (2ml) of TH and group 2 (small dose) was injected 20mg (1ml). Only one joint is injected by patient (IAI blindly). Evaluation will be conducted by a blinded observer at five times: baseline (T0), one week (T1), four (T4), eight (T8) and twelve (T12) weeks and the following assessment instruments were used: visual analogue scale for pain and swollen (VAS 0-10cm); wrist goniometry; chronic disease activity index (CDAI). Side effects and related events were reported in a medical questionnaire. The level of statistical significance was 5%.

Eligibility Criteria:
Inclusion Criteria:

* patients with established RA
* age between 18 and 65 years
* disease modifying anti-rheumatic drugs (DMARDs) stable for at least 3 months
* synovitis in wrist with pain visual analogic scale (VAS) between 4 and 8cm

Exclusion Criteria:

* patients with overlap syndromes
* polyarticular synovitis
* diabetes mellitus or uncontrolled hypertension and those with suspected local or systemic infection
Sleep Apnea: Age Effects On Prevalence and Natural History

To identify the prevalence of sleep apnea in men and its relationship to age, assess the natural history of the disorder, and predict those men at risk.

BACKGROUND:

Sleep apnea is potentially a life-threatening disorder commonly associated with the aging process. Often sleep apnea is accompanied by considerable morbidity for both physical and mental health; the associated excessive daytime sleepiness, cardiovascular abnormalities, and cognitive impairment impact greatly on daytime functioning. In 1990, the prevalence of sleep apnea in the general population was undetermined, and there was much speculation regarding its natural history.

DESIGN NARRATIVE:

For the prevalence study, 4,364 randomly-sampled men selected from the general population and stratified by age were evaluated for risk factors for sleep apnea. A total of 741 men found to be at risk were evaluated in the sleep laboratory to determine the degree, if any, of sleep apnea or sleep disordered breathing. Prior to recording subjects in the sleep laboratory, a thorough history was obtained from each subject and a physical examination completed. All men entering into the first four years of the prevalence portion of the study who were found to have sleep apnea or sleep disordered breathing were reevaluated yearly over a five year period in the natural history part of the study. The natural history portion also included 150 men previously studied in the sleep laboratory for apnea but who were not part of the random sample of 4,000 and who were not part of the prevalence study.

Eligibility Criteria:
stratified random sample based on risk severity for sleep disordered breathing based on phone interview
Sautour PHRC IR 2008

Fusarium are microscopic filamentous fungi that live as saprobiontics in outside environments. They are found in the soil, the air, in water and on numerous plants. The frequency of fusariosis is currently increasing and Fusarium-related mycoses are the 3rd most frequent invasive mycoses. Most cases have been reported in the United States, in France, in Italy and in Brazil. A few epidemiological studies have shown the role of water in the appearance of mycoses in highly immunodepressed patients. Few studies have focused on the role of water in the transmission of mycoses in hospitals. The aim of this prospective study is to describe, in time and pace, the contamination by Fusarium sp. in the water of two different hospitals (Dijon, Nancy), by taking into account factors such as seasons and major works (reconstruction of a hospital). In each hospital, one reconstruction site will be compared with a site not under reconstruction (control).

Water samples will be taken from the rooms of hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

all patients with new-onset fusariosis in the Adult Haematology, Internal Medicinie, Digestive Surgery and Rheumatology Departments

Exclusion Criteria:

none