cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Connecting the Residual Ear to the Cartilage Scaffold in First- vs. Second-Stage Surgery

Eligible patients will be admitted from the outpatient clinic to complete the relevant examinations after admission（Preoperative routine examination and chest CT）. The baseline parameters will be registered when admitted to hospital, including case number, diagnosis, sex, age, height, weight, and underlying medical conditions. Patients have at least 12 hours to consider participation in the study and will be given the opportunity to ask questions about the study. Written informed consent will be obtained by the surgical resident or the surgeon after admission to the hospital.

Randomization will be done by relevant member . After inclusion, patients will be allocated to one of the two study groups (First-stage Connection or Second-stage Connection) using an online randomization program. The perioperative care will be the same for all included patients.Surgery will be performed by experienced surgeons, with non-expanded ear reconstruction using autologous rib cartilage. The surgery normally comprises two stages. After each surgery, details and duration of the surgery will be documented. For each stage of surgery, patients are scheduled for visits about 3-6 months. In addition, after the total surgery, patients are to fill out 'Glasgow Benefit Inventory' and 'Patient and Observer Scar Assessment Scale'.


Eligibility Criteria:
Inclusion Criteria:

All consecutive patients between 6 and 30 years with a congenital concha-microtia8, admitted to our hospital are potentially eligible, and enrollment in the study will be based on the following criteria.

1. Patients were fully informed about the purpose, modalities and risks associated with this study, signed an informed consent form and were willing to be followed up.
2. Contrast-enhanced computed tomography (CT) scan shows he or she has 3.Patients can tolerate general anesthesia without severe chronic organic or mental illness.

Exclusion Criteria:

1. Patients combined with other ear diseases such as ear fistula, titis media, etc.
2. Patients receive other unrelated ear surgeries during the study
3. Skin in the surgical area with infection, ulceration, and scarring.
Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry

This study will assess the rates of serious adverse events and death in adult rheumatoid arthritis patients treated with etanercept over the long-term in real-life clinical practice. It will also assess whether there is any difference in the rate of serious adverse events in patients trated with etanercept in comparision to patients treated with conventional disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition quantify the efficacy of etanercept in this population by assessing the rates of important clinical outcomes such as changes in disease activity and disability/functioning.

patients recruited sequentially as seen in clinical practice

Eligibility Criteria:
Inclusion Criteria:

* adult
* rheumatoid arthritis
* group 1: initiating etanercept as first biologic therapy
* group 2: DAS28\<4.2, biologic naive and treated with non-biologic DMARDs

Exclusion Criteria:

* diagnosis of other inflammatory arthritis
Survival and 30-days Hospital Outcome in COVID-19 Patients in Upper Egypt

Through history, there have been plenty of pandemics however; the social response to corona virus disease (COVID-19) is unparalleled. It is assessed that almost four billion individuals are living in social segregation during this mother of all pandemics.

Initially described in China in December 2019, severe acute respiratory syndrome caused by corona virus 2 (SARS-CoV-2) has spread all over the world and by 18th July 2020- there was an emergent figure of 13,824,739 confirmed cases and 591.666 losses reported to the WHO. To date, Egypt reported slightly over 82,000 confirmed COVID-19 cases with 3858 deaths. The new pandemic is injuring not only health organizations of several countries but also the financial prudence universal.

Defining the clinical features and associated outcomes of patients diagnosed with coronavirus disease (COVID-19) is fundamental to improving our understanding and adequate management of this illness. Several articles have recently been published, describing the clinical features and outcomes of retrospective individuals with COVID-19


Eligibility Criteria:
Inclusion Criteria:

* This study included 1064 patients consecutively admitted to isolation hospitals in Upper Egypt during the period from 22 March to 23 June 2020

Exclusion Criteria:

* only hospitalized confirmed cases of COVID-19 were included.
REVADE : Right Ventricular Function and Exercise in Left Ventricular Assist Device Patients : Echocardiographic Study

Heart failure is a public health problem, responsible for 150.000 admissions, 32.000 deaths, 1% of public health expenditure each year in France. Heart transplantation remains the standard of care in patients for which medical therapy is not sufficient. But heart transplantation is a limited resource, as a result of donor shortages. It is therefore possible to consider mechanical circulatory support for patients awaiting heart transplantation or for those who are not suitable for transplantation. Left Ventricular Assist Devices (LVAD) are portable pumps which help the left side of the heart to provide appropriate "cardiac" output. in this type of device, right heart is not assisted and must work on its own, LVADs are thus implanted in patients whose right ventricular function is normal.

The aim of the REVADE study is to assess right ventricular echocardiographic parameters in this population, especially on physical exercise, for a better understanding of right ventricular adaptation to this long-term modified pressure pattern.

This is a non-randomized, single-center, prospective investigation on exercise capacities of LVAD recipients.

LVAD patients already have in our unit the following regular monitoring:

* clinical examination
* Minnesota Living with Heart Failure Questionnaire (MLHFQ)
* SF-36 Health Survey
* Six-Minute Walk Test
* resting echocardiography
* routine blood tests.

The REVADE pilot study consists in adding 2 cardiopulmonary exercise testings to their existing follow-up : peak oxygen consumption (VO2 max) and stress echocardiography.

We plan to do 1 stress echocardiography on a supine bicycle over the follow-up, and 1 peak oxygen consumption recorded while breathing through a gas analyzer.

Total study length of time will be 1 year. Expected number of enrolled patients is 18.

Eligibility Criteria:
Inclusion Criteria:

* left ventricular assist device (LVAD) recipients
* age \> 18 years
* able to give consent

Exclusion Criteria:

* adults legally protected (under judicial protection, guardianship, or supervision) or deprived of liberty
* patients unable to provide sufficient effort for exercise testing
* poor echogenicity
Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults

The primary objective of this study is to evaluate the efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen consisting of abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in HIV-1 infected participants.


Eligibility Criteria:
Key Inclusion Criteria:

HIV-infected adult participants who meet the following criteria will be given the option to participate in the study:

* Currently receiving ABC/3TC plus a third antiretroviral (ARV) agent for ≥ 6 consecutive months preceding the screening visit. For subjects with 3 or more ART regimens, a regimen history must be provided to the Sponsor for approval. Allowed third antiretroviral agents include LPV/r, ATV+RTV, ATV+COBI (or ATV/COBI FDC), DRV+RTV, DRV + COBI (or DRV/COBI FDC) FPV + RTV, SQV + RTV, ATV (no booster), EFV, RPV, NVP, ETR, RAL or DTG
* Documented plasma HIV-1 RNA levels \< 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay). In the preceding 6 months prior to screening, one episode of "blip" (HIV-1 RNA \> 50 and \< 400 copies/mL) is acceptable, only if HIV-1 RNA is \< 50 copies/mL immediately before and after the "blip".
* Plasma HIV-1 RNA \< 50 copies/mL at screening visit
* Individuals will have no evidence of previous virologic failure on a PI+RTV or integrase strand transfer inhibitor-based regimen (with or without resistance to either class of ARV).
* All documented historical plasma genotype(s) must not show resistance to tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC), including, but not limited to the presence of reverse transcriptase resistance mutants K65R, K70E, M184V/I, or thymidine analog associated mutations (TAMs) (TAMs are: M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R). If a historical genotype is not available or subject has 3 or more ART regimens, subject will have proviral genotype analysis prior to Day 1 to confirm absence of archived resistance to TDF or FTC.
* Adequate renal function defined as having an estimated glomerular filtration rate of ≥ 30 mL/min as calculated by Cockcroft-Gault (eGFR-CG)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer

The primary objectives of this study are the following:

Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC)


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of the prostate
* Radiographic evidence of metastatic disease
* Progressive disease meeting at least one of the following criteria:

  1. a sequence of at least 2 rising PSA values measured at a minimum of 1 week apart with a 2 ng/mL minimum starting value, or
  2. progression according to RECIST criteria for measurable lesions, or
  3. appearance of 2 or more new lesions on bone scan.
* History of prior taxane-based chemotherapy for metastatic prostate cancer
* For patients without a history of surgical castration, continued GnRH analog administration is required
* ECOG Performance status of 0 or 1
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Treatment with external beam radiotherapy ≤ 14 days before enrollment or radiopharmaceutical ≤8 weeks
* ≤ 4 weeks since receipt of most recent prior chemotherapy, non-GnRH analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and \<6 weeks since receipt of prior bevacizumab.
* Known CNS metastases (epidural disease is allowed if it has been treated and there is no progression in the treated area).
* Significant cardiovascular disease
* LVEF \< 50% by MUGA or ECHO
* Treatment of infection with systemic anti-infectives within 7 days before enrollment (with the exception of uncomplicated urinary tract infection)
* Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except that use of low dose coumarin-type anticoagulants or heparins for prophylaxis against central venous catheter thrombosis is allowed
* Major surgical procedure ≤30 days before enrollment or not yet recovered from prior major surgery
* Presence of peripheral edema \> Grade 2
* Known positive test for HIV, hepatitis C, chronic or active hepatitis B
* Serious or non-healing wound
* Unable to begin protocol specified treatment within 7 days after enrollment
* Other investigational procedures are excluded.
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients

To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China.

To track the patients'situations during one year after surgery and to collect the relevant clinical data.


Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with Perimount 6900PTFX after 2012-11-19 or with Perimount 2800TFX after 2013-8-20
* Patients sign the Inform Consent Form (ICF) and agree to join the study

Exclusion Criteria:

* Don't have any specific exclusion criteria.
Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial

A postoperative autologous blood patch (ABP) intervention trial for patients who underwent lung resection for cancer to examine its effectiveness in preventing a prolonged air leak.

AIM 1: To determine the safety and efficacy of autologous blood patch (ABP) as a means to reduce the rate of prolonged air leak (PAL) after lung cancer resection

AIM 2: To prospectively examine variation in morbidity and quality of life between patients with and without a PAL

The plan for this trial is to establish the safety and efficacy of ABP as a means of reducing PAL following lung cancer resection. Patients with an air leak on the morning of postoperative day 3 after elective lung resection for cancer will be randomized to ABP on postoperative day 3 and day 4 (if an air leak remains present), or standard care (n=60 per arm). This will be a multi-institutional randomized, controlled trial open for enrollment at centers in the United States and Canada. The study methods and design are compliant with the Consolidated Standards of Reporting Trials (CONSORT).

Subjects will be consented on postoperative day 3, with autologous blood patch intervention occurring on day 3 or day 4. If subjects are randomized to the ABP arm of the trial, they will receive 60-100 ml of autologous blood sterilely drawn from a peripheral vein and immediately instilled into the chest tube.

Subjects will then follow up either in clinic or via telephone to answer the questionnaire. If the subject is being seen in person, they will be handed a questionnaire form to complete. This form will be kept and stored as source documentation. If the patient is answering the questionnaire via telephone, the study team personnel will record their answers on the questionnaire form, indicating it was completed by the subject but recorded by study team personnel. A telephone encounter note will be recorded and stored as source with the completed questionnaire. Follow up occurs at 30 days (+/-5 days) postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent elective wedge resection, segmentectomy, lobectomy, or bilobectomy for suspected non-small cell lung cancer
* Patients that have reviewed and signed the Informed Consent Form, had an opportunity to ask questions, and consent to have their de-identified data included in the study
* Patients who have an air leak on the morning of postoperative Day 3
* Age ≥18 years old

Exclusion Criteria:

* Patients who undergo pneumonectomy, sleeve lobectomy, chest wall or diaphragm resection, or bilateral procedures.
* Age \< 18 years old
* Women who are pregnant
Factors Associated With Decisions to Withhold or Withdraw Intensive Care

Medical and socioeconomic data are extracted from the Swedish Intensive Care Registry (SIR), the Swedish National Patient Registry and Statistics Sweden for all adult patients admitted to in Swedish intensive care units between 2014-01-01 and 2020-12-31 with a diagnosis of sepsis and/or acute respiratory distress syndrome (ARDS) and/or coronavirus 19 (COVID-19) infection, and registered in SIR. The impact of demographic and socioeconomic factors on decisions to withhold or withdraw intensive care, and on mortality, are studied and statistically adjusted for level of chronic comorbidity and severity of acute illness.

Patient identification and data acquisition With permission from the ethical board of Sweden, all registered intensive care episodes with a diagnosis of sepsis, acute respiratory distress syndrome (ARDS) or coronavirus 19 (COVID-19) and admission between 2014-01-01 and 2020-12-31 are identified in the Swedish Intensive Care Registry (SIR). Basic demographic data (age, sex) and intensive care data from SIR are combined with comorbidity data from the National Patient Registry of the Board of Health and Welfare (Socialstyrelsen), and data on country of birth, household size, education and economy from Statistics Sweden (SCB) to produce a pseudonymized study data set. For patients with multiple intensive care episodes, the first one is used.

Analysis Descriptive data on the frequency of decisions to withhold or withdraw intensive care, and on demographic and socioeconomic factors, morbidity and mortality in patients with or without such decisions, are produced. Logistic regression is used to assess the association between demographic and socioeconomic factors and limitations in intensive care, adjusting for acute and chronic morbidity and accounting for multicenter data. Secondarily, association between the same factors and mortality is studied.

Eligibility Criteria:
Inclusion Criteria:

* Registered intensive care episode with relevant diagnosis

Exclusion Criteria:

* None, if inclusion criteria fulfilled
Follow Up Study for Treatment of Parkinson's Disease With Subthalamic Deep Brain Stimulation

This study aims to evaluate the long term effect of deep brain stimulation in the the subthalamic nucleus (STN) in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* Disease duration longer than 15 years
* Had STN deep brain stimulation implant more than 10 years
* Available and willing to be followed-up according to study protocol

Exclusion Criteria:

* Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
* Epilepsy
* Pregnant female
* History of severe neuropsychiatric disease
* Patients are taking part in other clinical trials in recent several months
Current Intensity for the Obturator Nerve Block

The purpose of the present study was to find out the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during the obturator nerve block procedure for TURP.

During the transurethral resection of bladder tumors (TURBT) procedure under spinal anesthesia, the obturator nerve block is required to prevent the accidental movement of adductor longus muscles by electrical stimulation. However, during general anesthesia, the contraction of the adductor longus muscle would be lost due to deep neuromuscular blockade. However, some reports showed that the contraction of the adductor longus muscle occurs even in the deep neuromuscular blockade.

The current intensity for the nerve stimulation during nerve block is 0.3--0.5 mA when the needle tip is near the nerve. However, it is still unknown what current intensity is required to show the contraction of the adductor longus muscle when the patient is in a deep neuromuscular blockade.

Therefore, in this study, investigators aimed to determine the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during obturator nerve block for TURP. In addition, investigators aimed to determine that the obturator nerve block is required during the TURP procedure in patients with deep neuromuscular blockade during general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing TURP procedure

Exclusion Criteria:

* Patients with anatomical or functional anomaly in the upper airways
* Patients with neuromuscular disease
* Patients with hip joint disorders
* BMI of \< 18.5 or \> 30.0 kg/m2
Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status

The objective of this research is to test the efficacy of Zn biofortified wheat in increasing Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy

Exclusion Criteria:

* unhealthy
Comparative Study Between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for Post Operative Analgesia in Children Undergoing Infraumblical Surgeries

Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia

Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia in children undergoing infraumblical surgeries

Eligibility Criteria:
Inclusion Criteria:

- 120 children, aged between 4 and 7 years undergoing infraumblical surgeries as ( hypospadias , inguinal hernia and orchopexy ).patients will be selected according to ASA physical status class I to II from both genders who be able to swallow tablets.

Exclusion Criteria:

* parents' refusal.
* urgent cases.
* other contraindications of regional anesthesia (e.g. infection at injection site, coagulopathy and allergy to bupivacaine)
* Insulin dependent diabetes
* Thyroid disease
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

The minimum dataset collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The data collected include information on:

* Demographics of mother and infant
* Mother's health, labor and delivery
* Infant's health, medical interventions, and clinical outcomes

These data are used to: provide participating hospitals with reporting for use in quality improvement; evaluate associations between baseline characteristics, treatments, and outcomes; and track trends in disease and therapy.

Eligibility Criteria:
Inclusion Criteria:

* All local births with gestational ages of 22 weeks 0 days - 23 weeks 6 days, regardless of pregnancy outcome or neonatal intensive care (NICU) admission; AND
* All outborn NICU admissions with gestational age at birth of 22 weeks 0 days - 23 weeks 6 days
* Optional: Centers who desire to include data for NICU admissions of infants born \<22 weeks' gestation may also submit these data.