cyrilzakka/clinical-trials huggingface dataset:
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life

The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.

Systemic sclerosis (SSc) is a multisystem autoimmune disease that is characterized by progressive vasculopathy, excessive fibrosis, and immune system activation. Fatigue in SSc is common and greatly impacts quality of life: The prevalence of fatigue in SSc patients is significantly higher than the general population. Raynaud phenomenon (RP) in SSc is not only the most common SSc manifestation, affecting nearly all but is often the earliest SSc symptom. SSc-RP is the highest ranked SSc-related symptom affecting quality of life, and is a major cause of SSc-related morbidity. There are currently no approved medications to treat RP, SSc-associated RP phenomenon or fatigue in SSc. Thus, a non-pharmacologic intervention has the potential to provide SSc patients with a new treatment modality without common limiting side effects, and access. The Apollo wearable provides transcutaneous vibratory stimulation, and can be worn on the wrist or ankle.

Goal: To recruit 160 SSc patient participants into this randomized, sham-device controlled clinical trial. Patients will be randomized 1:1 to receive the Apollo vs. sham wearable, which they will wear daily for 6 weeks.

Outcome measures focus on quality-of-life.

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Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Ability to provide written informed consent,
3. Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
4. Baseline score ≥55 on the FACIT-Fatigue scale,
5. Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
6. Steady daily doses and any immunosuppressive medication, vasodilators or other medications used to treat pulmonary hypertension, antidepressants and anxiolytic use for 4 weeks prior to baseline
7. Currently owns and operates an iOS or Android smart phone regularly
8. Ability to comply with the clinical visits schedule and the study-related procedures.

Exclusion Criteria:

1. History of sympathectomy or stellate ganglion block
2. History of Botox injections to the digits within the last 3 months
3. Diabetes mellitus
4. Major surgery within 8 weeks
5. Hospitalization for any reason within four weeks of the study baseline visit
6. Active malignancy
7. Pregnant or breastfeeding women,
8. End-stage renal disease (estimated glomerular filtration rate \< 15 mL/min/1.73m2) or on dialysis,
9. Hepatic insufficiency as defined by function worse than Child-Pugh Class B
10. Medication exclusions:

    1. actively prescribed standing doses of beta-blockers,
    2. actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.
Intraoperative Spillage of Bile and Gallstones During Laparoscopic Cholecysetectomy

1. determine the most important factors which is responsible for the outcome post bile and gallstones spillage during laparoscopic cholecystectomy
2. the management of complications of bile and gallstones spillage

Laparoscopic cholecystectomy is preferred surgical treatment for symptomatic gallstones .laparscopic procedure is superior to open procedue .the incidence of gallbladder perforation and spillage of bile and gallstones has been found as high as 40% .complications and management of gall bladder perforation and spillage of gallstones and bile

Eligibility Criteria:
Inclusion Criteria:

* all age groups
* only laparoscopic cholecystectomy
* all types ,numbers and sizes os gall stones

Exclusion Criteria:

* open cholecystectomh
* patient refuse to enrol this study
Reappraisal of Atrial Fibrillation: RACE-V - Work Package 5

In the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of atrial fibrillation (AF). Also the contribution of the individual genetic background will be investigated. Furthermore, the investigators aim to identify clinical parameters and biomarkers informing on the main mechanisms of AF progression in atrial tissue.

For this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.

An estimated 380 patients will be included

Four patient categories will be included enabling to study patients with different stages of AF progression;

1. Patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group),
2. Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring,
3. Patients with self-terminating atrial fibrillation at inclusion, and
4. Patients with non-self-terminating atrial fibrillation at inclusion. At baseline in-depth phenotyping and genotyping will be performed. Continuous rhythm monitoring will also be performed in all patients. The combination of extensive phenotyping, genotyping and atrial fibrillation burden follow-up offers the unique opportunity to study the atrial tissue alterations and atrial gene expression changes in different stages of atrial fibrillation progression and to correlate these data to the phenotype of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Undergoing first elective open chest cardiac surgery or surgical ablation for atrial fibrillation;
* Able and willing to sign informed consent for the registry;
* Able and willing to undergo implantation of implantable loop recorder (unless the patients has a pacemaker or implantable cardioverter-defibrillator (ICD) with atrial leads)

Exclusion Criteria:

* • Deemed unsuitable or not willing to undergo implantation of implantable loop recorder or attend follow-up visits.

  * Pregnancy.
  * Life expectancy of less than 2.5 years.
  * History of prior cardiac surgery or ablation for atrial fibrillation.
Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis.

To evaluate the efficacy and tolerability of Auris-Sedina in the symptomatic control of otalgy in patients with and without acute external otitis compared with use of Otosynalar®.

Phase III open Study, multicenter, prospective, randomized entrance of a total of 188 patients, 94 patients will receive medication test and 94 patients will receive Otosynalar®.

Patients will be assessed until the clinical condition has been resolved or a maximum of 3 days.

188 patients of either gender or race, who have at least two of the following symptoms: pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo. And with a clinical or non-acute external otitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with otalgy or not, with acute external otitis ;
* Patients with at least two symptoms of otalgy (pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo) with the Visual Analogic Scale score between 4 and 8 (mild to moderate);
* The patient must present otalgia in one ear;
* Children above 6 years of age;
* Adults over 18 years of age;
* Patients who consent to participate in the study;
* Patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test.

Exclusion Criteria:

* Patients with sensitivity to any component of the formula;
* Patients pregnant or lactating;
* Non visualization of the tympanic membrane of obstruction by cerumen;
* Patients with evidence of any wound or scratch on the ear (ulcerative lesion);
* Patients who are making use of any other medication that might interfere with the evaluation of effectiveness of study (such as antibiotics, antiinflammatory, solutions ear);
* Patients who have severe classification in the Visual Analogic Scale score 9 or 10 in any of the symptoms listed in the questionnaire;
* Patients with otalgy not otological origin;
* Patients with otitis, except acute external otitis ;
* Patients who have epiglottitis;
* The patient with infection;
* Patients who can not follow the procedures clarified in this protocol.
HbA1c in Intracytoplasmic Sperm Injection

ICSI has increased nowadays for treating cases of longstanding infertility . HbA1c has an important value in evaluating glucose level in blood

- The level of HbA1c in blood denotesnthe glycemic control over the past 3 months . Its regulation is very important in human reproductive life

Eligibility Criteria:
Inclusion Criteria:

* females with infertility from 20 to 42 years old

Exclusion Criteria:

* females with age below 20 or above 42 years
Magnetic Resonance Elastography (MRE) as a Predictor of HCC Recurrence After Radiofrequency Ablation (RFA)

The purpose of this study is to determine:

* The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA treatment
* The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis

To evaluate whether MRE score reflecting hepatic fibrosis can predict the recurrence of HCC within 2 years after RFA treatment

* Local recurrence/intrahepatic distant recurrence
* Multivariable analysis including several related factors to find whether MRE score is an independent predictor of HCC recurrence even after adjusting other factors (etiology of liver disease, size of HCC, vessel invasion, HBsAg titer, etc.)

To find the efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as single hypervascular hepatocellular carcinoma initially
* AJCC stage I HCC
* Child-Pugh class A
* Planning radiofrequency ablation for HCC
* Voluntary agreement for this study

Exclusion Criteria:

* Decreased kidney function (GFR \< 70 mL/min/kg)
* Contraindication to MRI (pacemaker, defibrillator)
* Contrast media hypersensitivity
* Other primary malignancy
* Acute viral hepatitis
* Prior history of liver transplantation
* Thrombosis in splenic vein or portal vein
* Patients who were enrolled to other clinical trials within 4 weeks
* Other severe chronic disease or psychiatric disease
* Pregnant or milk-feeding women
* Patients with coagulopathy, high risk of bleeding for the liver biopsy
* Patients who disagree to participate in this study
A Study to Compare Two Anti-HIV Drug Combinations

The purpose of this study is to compare 2 anti-HIV drug combinations.

Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3.
* Are at least 18.
* Are able to complete the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have taken any anti-HIV medications for more than 2 weeks.
* Are pregnant or breast-feeding.
TandemHeart Experiences and MEthods (THEME Registry)

This study is intended to be a multicenter, prospective observation registry. By collecting prospective descriptive data, provide insight into disease defining characteristics resulting in the clinical decision to use TandemHeart® or LifeSPARC™ System for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal/exit strategies.

The TandemHeart or LifeSPARC percutaneous extracorporeal life support system is used to support circulation. The percutaneous cannulas facilitate access to the venous and arterial circulatory vessels. When connected to the TandemHeart or LifeSPARC centrifugal pump, mechanical support is provided with sufficient cardiac power to perfuse the organs of the body.

It is anticipated that THEME Registry™ analysis will provide insight into disease defining characteristics resulting in the clinical decision to use the TandemHeart or LifeSPARC System for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal. The progression of the illness prior to, during and following support will be collected. The THEME Registry will collect descriptive data regarding patient selection criteria and the clinical management of the patient including strategies used to wean and remove the device. Specifically the objectives of the THEME Registry are:

* Summarize the characteristics of the patients who receive the System for temporary percutaneous mechanical support with or without an oxygenator, including demographics, pre-implant medical history, details of present illness, exit strategy.
* Evaluate the timing of initiation of System support in relation to the progression of the presenting illness and the association of this with clinical outcomes.
* Collect descriptive data related to clinical management of the patient while on mechanical support, including procedural details, duration of support, anticoagulation, hemodynamics and biochemical parameters to define trends in clinical care and the association of this decision-making with clinical outcomes.
* Collect hospital discharge information including Intensive Care Unit (ICU) and Hospital length of stay (LOS).
* Collect survival and exit strategy status at 30 and 180 days post-initial System insertion.
* Collect serious adverse events from the time of Pump insertion through removal of the System (or Pump).
* Provide data regarding patient characteristics and outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has had the TandemHeart or LifeSPARC System inserted percutaneously (e.g. in the cath lab or peri-operatively)
2. Age \>= 18
3. Patient (or legally authorized representative \[LAR\]) has signed informed consent

Exclusion Criteria:

1. Patient is incarcerated (prisoner)
2. Participation in a clinical trial of an investigational drug or device
PROSPECTIVE OPEN LABEL CLINICAL TRIAL TO ADMINISTER A BOOSTER DOSE OF PFIZER/BIONTECH OR MODERNA COVID-19 VACCINE IN HIGH-RISK INDIVIDUALS

The recent rise in infections with the Omicron variant of the SARS-CoV-2 is alarming. Equally disconcerting is the fact that individuals who were previously vaccinated (\< 6 months) and have co-morbidities that are considered high risk, are getting re-infected...a process referred to as "breakthrough". There is some evidence that in these high risk individuals, the gradual decrease in immunity against the virus as depicted by a drop in anti-SARS-CoV-2 antibodies, is responsible (partially or wholly) for this reinfection. In this study, we intend to give a booster does Pfizer/BioNTech and/or Moderna and ascertain the levels of antibodies at various times pre and post vaccination. The incidence of infection with SARS-CoV-2 after booster vaccination will also be obtained.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and over that have been fully vaccinated (2 doses) with the Pfizer/BioNTech COVID-19 vaccine (BNT162b2) and with the 1st booster at least 90 days prior to the 2nd booster
* Healthcare workers employed by and/or affiliated with DHR Health, Renaissance Medical Foundation, DHR Partners, Starr County Memorial Hospital
* Any adult with any of the following risk factors for severe COVID-19 disease progression (as outlined by the CDC)

Exclusion Criteria:

* Previous history of allergic reaction to vaccination
* less than or equal to 3 months from last booster dose of vaccine
* active SARS-COV-2 infection
* less than or equal to 21 days of full recovery from SARS-CoV-2 infection
* less than or equal to 14 days of any vaccination
* vaccinated with any other available COVID-19 vaccine other than Pfizer/BioNTech or Moderna
* Healthcare workers not employed by and/or affiliated with DHR Health, Renaissance Medical Foundation, Star County Memorial Hospital or non DHR Partners
Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

This is an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。


Eligibility Criteria:
Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II)
* All genders，range from 18～65 years old
* Karnofsky performance status(KPS) ≥ 80
* Clinical stage III\~IVb(UICC 7th)
* Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
* Without significant cardiac，respiratory，kidney or liver disease
* Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
* white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
* alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 1.5×upper limit of normal(ULN), bilirubin \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
* Inform consent form

Exclusion Criteria:

* Distance metastases
* Second malignancy within 5 years
* Drug or alcohol addition
* Do not have full capacity for civil acts
* Active systemic infections
* Chronic consumptions
* Mental disorder
* Pregnancy or lactation
* Concurrent immunotherapy or hormone therapy for other diseases
* Severe complication, eg, uncontrolled hypertension
Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma

The investigators aim to pilot the role of school based intervention consisting of enhanced integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.

By piloting this school based intervention, the investigators hope to learn from this study the best way to design and implement more cost and time efficient large-based school-based environmental interventions that may potentially help a community of children with asthma, allergic diseases, and its associated morbidity.

Eligibility Criteria:
Inclusion Criteria:

* grades K-8 with asthma attending sampling/intervention schools

Exclusion Criteria:

* moving schools
A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient, \>/= 18 years of age
* Chronic Hepatitis C of \>/= 6 months duration at screening
* HCV genotype 1 and quantifiable HCV RNA at screening (Roche COBAS TaqMan HCV test)
* Naïve for treatment with interferon (pegylated or non-pegylated)
* Body Mass Index (BMI) 18-35 inclusive, minimum weight 45 kg
* Females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception

Exclusion Criteria:

* Pregnant or lactating women and males with female partners who are pregnant or lactating
* Decompensated liver disease or impaired liver function
* Cirrhosis or incomplete/transition to cirrhosis
* Non-hepatitis C chronic liver disease
* Hepatitis B or HIV infection
* History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
* History of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
* History of drug or alcohol abuse within the last year or alcohol consumption of \> 2 units per day; cannabinoid use is excepted
Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial

This is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. The objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age, of either sex and any race
* diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines research
* Subjects should be regularly scheduled for bilateral functional endonasal endoscopic sinus surgery
* Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
* Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
* Nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control.

Exclusion Criteria:

* Women must not be pregnant, breast feeding, or premenarcheal.
* Subjects who have required oral corticosteroids within the previous four weeks prior to surgery.
* Subjects who have required nasal corticosteroids within the previous one week prior to surgery.
* Subjects with known allergic reaction on tetracyclines, diabetes (type 1 and 2), renal insufficiency, severe liver disease, systemic diseases affecting the nose (e.g. M. Wegener), prior surgeries of the paranasal sinuses.
* Patients with the following diseases should be excluded :

  1. Cystic fibrosis based on positive sweat test or DNA alleles
  2. Gross immunodeficiency (congenital or acquired)
  3. congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD)
  4. Non-invasive fungal balls and invasive fungal disease
  5. systemic vasculitis and granulomatous diseases
  6. Cocaine abuse
  7. Neoplasia