cyrilzakka/clinical-trials huggingface dataset:
Pragmatic Clinical Trials in Scleroderma

Systemic Sclerosis (SSc) is an autoimmune connective tissue disease characterized by autoantibodies, fibrosis and microvascular injury and endothelial cell activation that results in vascular damage. Vascular injury induces both innate and acquired immune responses resulting in fibroblast activation and organ fibrosis. SSc may target multiple organs, including: skin, lungs, heart, vascularization, kidneys, the gastrointestinal tract and musculoskeletal structures. Mortality among scleroderma patients is significant, with a 3.5 standardized mortality ratio (SMR) in studies of prevalent cases. This mortality may be increased in the early years of the disease, reaching a SMR of 4 in a multinational inception cohort. In general, treatment strategies target involved organs as early as possible to avoid damage. Many treatment options are available for each manifestation, but evidence with respect to the order of treatment is scarce. Financial costs, the lack of proper outcome measures, difficulty to recruit patients as a rare disease, all prevent the development of new big clinical trials, oppositely to other common diseases such as stroke or cancer. The heterogeneous features of SSc may make trials challenging. The current guidelines available are the British guidelines (2017) , and the updated European League Against Rheumatism (EULAR) guidelines, published in 2017. Management guidelines have some gaps regarding second-line treatment, combinations and there are no proposed algorithms.

With the pragmatic trials, the investigators intend to fill the gap between the complicated randomized clinical trials and the observational studies. Using the treatments that have already been proved useful in SSc, in an open-label randomized way and based on some refined expert-made algorithms, will allow the investigators to establish the order in how to use them.

Patients will be offered to participate with the collection of their clinical data and, if they give their consent, they will be randomized according to the algorithms. There will be an optional part of the study consisting in the collection of blood samples and skin samples for future research.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with an age \>18 years meeting the 2013 SSc classification criteria managed at the Rheumatology division, St. Joseph's Healthcare London.
* Patients who refuse to be randomized for treatments but wish to provide their data for the registry will also be included, after signing the informed consent form.

Exclusion Criteria:

* Refusal to participate or to sign an informed consent form.
Care EcoSystem: Ochsner Health System

1. To determine the feasibility and acceptability of the Care Ecosystem program in the Ochsner clinical setting.
2. To assess the effect of the Care Ecosystem program on health care cost and quality care quality as measured by primary outcome variables.

   * Adapted from the Care Ecosystem, memory.ucsf.edu/Care-Ecosystem


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥55 years of age at baseline
* Probable dementia diagnosis as evidenced by one or more of the following criteria:

  * Dementia listed on medical record problem list as of January 1, 2015 or later, or, in the opinion of the referring provider has dementia
  * Prescribed with any of the following: donepezil, memantine, galantamine HBR, rivastigmine, or tartrate; or, in the opinion of the referring provider, could take such medication
* Lives in community

Exclusion Criteria:

* Documented history of Multiple Sclerosis, ALS, Traumatic Brain Injury, Huntington's Disease, Schizophrenia, Bipolar Disorder, or current Substance Abuse Disorder
* Lives in a nursing home or assisted living facility
* Unable to complete monthly telehealth or phone visits
Labial Bone Thickness Around Immediate Implants in the Esthetic Zone Following a Novel Socket Evaluation System

The anterior maxilla is a particularly challenging area for immediate implant placement due to its thin buccal bone walls. These walls are more susceptible to resorption after tooth extraction, which can lead to significant bone loss and inadequate support for an implant. However, Different socket dimension may affect the amount of bone formed labial to the implant, regardless of the garfting procedure.

Bone formation labial to the immediate implant is not related to the initial thick- ness of the labial plate of bone, rather than the initial labio-palatal socket dimension. this study aims to evaluate the bone formed labial to the implant following a Novel Socket Evaluation System.

Eligibility Criteria:
Inclusion Criteria:

* Immedaite implants in anterior maxilla
* thick gingival phenotype
* intact but thin labial plate of bone (≤1mm)
* sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)

Exclusion Criteria:

* smokers
* pregnant women
* patients with systemic disease
* patients with parafunctional habits such as bruxism or clenching,
* infected socket
* periapical pathosis
* history of radiotherapy or chemotherapy within the past 2 years.
Community-Engaged Options to Facilitate Opioid Reduction

This study investigates how adults prescribed opioids for chronic noncancer pain respond to invitations to try non-opioid options of massage therapy, yoga therapy, chiropractic and physical therapies. Due to the COVID-19 pandemic, these options will be available via telehealth consultation visits using a computer or smartphone with internet connection. The investigators will measure effects on pain, pain-related symptoms, and opioid use over time using a single-group design.

Participants will be recruited from local primary care practices and asked to complete a baseline survey. They will then meet with a registered nurse via teleconference for a complete pain assessment. At the end of the session, participants will be asked to choose two of four available modalities for telehealth consultation. Participants will be scheduled for six telehealth sessions, once per week x six weeks with three consultations per each chosen therapy. Measurements of pain, mood, sleep, medicine use will be captured at baseline, three weeks and six weeks and examined for changes over time.

Eligibility Criteria:
Inclusion Criteria:

* enrollment in treatment at the CHAS Perry St or partnering clinic;
* age greater than 18 years;
* ability to read, speak, and write English;
* diagnosed with a chronic, non-cancer-based painful medical condition;
* ability to provide informed consent.

Exclusion Criteria:

* pregnancy;
* diagnosis of a cancer-based painful medical condition;
* any other medical or psychiatric condition that the PI or Co-PI physician of record determine might compromise safe study participation (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)
A Prospective, Post-market, Multi-center Feasibility Study of the BioDuct® Meniscal Repair Device

To demonstrate repair of the meniscus at 6 months, as evaluated by MRI, will be observed; and clinical qualitative assessments will improve from preoperative to postoperative time points with the BioDuct® Meniscal Repair Device.

To demonstrate repair of the meniscus 6 months postimplantation of the BioDuct® Meniscal Repair Device, utilizing MRI.

To evaluate clinical success by comparing the following qualitative criteria at 2 years postoperative to preoperative findings: effusion, swelling, pain, catching, locking, focal joint line pain and mechanical symptoms, if present preoperative. Clinical success is defined as no worsening for any of these criteria and improvement in at least one of these criteria.

Eligibility Criteria:
Inclusion Criteria:

* A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
* B. Patient is a male or non-pregnant female age 45 years or younger at time of study device implantation.
* C. Patient is a candidate for repair of one longitudinal vertical tear (bucket handle) fully located in the red-white (vascular-avascular) zone of the meniscus (3-5 mm from the synovial-meniscus junction) or repair of one longitudinal vertical tear (bucket handle) primarily located in the red-white zone of the meniscus, but partially (\< 30% of total length) extending into the red zone (\< 3 mm from the synovial-meniscus junction) and/or into the white zone (\> 5 mm from the synovial-meniscus junction).
* D. Patient does not require more than three BioDuct® Meniscal Repair Devices for the meniscal tear.
* E. Patient requires suture only for fixation at the site where the study device will be used.
* F. Patient is willing and able to comply with postoperative scheduled MRI and clinical evaluations and rehabilitation.

Exclusion Criteria:

* G. Patient has a Body Mass Index (BMI) \> 35.
* H. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
* I. Patient has horizontal, transverse, degenerative complex tears.
* J. Patient has ACL and/or PCL deficiencies within the operative knee and is not undergoing concomitant repair of these deficiencies.
* K. Patient requires bilateral meniscal repair.
* L. Patient requires meniscectomy.
* M. Patient presents with abnormal degenerative osteoarthritis of the joint \[e.g. International Cartilage Repair Society (ICRS) Grade III or higher and/or Modified Outerbridge Grade III or higher\].
* N. Patient has undergone previous meniscal repair to the operative knee.
* O. Patient has a knee joint with greater than 5º anatomic axis misalignment.
* P. Patient has active synovitis.
* Q. Patient is a prisoner.
Assessment the Cancer Risk of Indeterminate Thyroid Nodules Through Integration of Clinical, Ultrasonographic and Multiomic Features

Indeterminate thyroid nodules have a mild risk of malignancy (15-30%). The aim of our study is to individuate new biomarkers of thyroid carcinoma through multiomic analyses of blood samples and of specimen samples of patients with indeterminate thyroid nodules.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda Classification of thyroid nodules)

Exclusion Criteria:

* Patients with concomitant thyroid nodules of Bethesda Class V or Class VI
* Patients with preoperative diagnosis of lymph node metastases of central or lateral neck compartment
* Patients with distant metastases
CHOICES: Understanding Clinical Trials as a Treatment Option

The goal of this study is to determine whether having a telephone discussion with a nurse educator about making treatment decisions and participating in a clinical trial increases trial participation.

The investigators hypothesize that the participants in the intervention group will be more likely to take part in a clinical trial than those in the usual care group.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are potentially eligible for one of the designated clinical trials on the basis of automated data from pathology reports and other databases

Exclusion Criteria:

* Patients who meet specific exclusion criteria for designated clinical trials
COVID 19 Viral Clearance Among the Infected Healthcare Workers In Assiut University Hospitals

This work was aimed to determine the time of COVID 19 viral clearance in healthcare workers, assessment of clinical presentation and severity of COVID 19 infection among healthcare workers and discover relation between the time of COVID 19 viral clearance resolution of symptoms

COVID-19 has been spreading rapidly globally, with a considerable impact on global morbidity, mortality and healthcare utilization. This viral disease is caused by the Coronaviruses (CoV) which belong to the genus'coronavirus' of the Coronaviridae family.

Coronaviruses are enveloped positive strand RNA viruses with the largest known RNA genomes-30-32 kb-with a 50 -cap structure and 30 -poly-A tail (Lei et al.2018). The transcription works through the replication-transcription complex (RCT) organized in double-membrane vesicles and via the synthesis of subgenomic RNAs (sgRNAs) sequences. Of note, transcription termination occurs at transcription regulatory sequences, located between the so-called open reading frames (ORFs). In the atypical CoV genome, at least six ORF scan could be present (Woo et al., 2020) .

Health workers are at the front line of the COVID-19 outbreak response and as such are exposed to hazards that put them at risk of infection (Li e al.,2020). thus keeping the implementation of infection prevention and control (IPC) and its knowledge and practice are of great importance in healthcare settings to protect them from infections (Wang et al., 2020).

Eligibility Criteria:
Inclusion Criteria:

* Covid 19 infected healthcare workers.

Exclusion Criteria:

* Risky healthcare workers (diabetic hypertensive and more than 50 years)
Influence of Iyengar Yoga on the Bio-functional Age of Postmenopausal Women

The purpose of this Study is to find out if Iyengar-Yoga has a rejuvenating effect on women after menopause. The biofunctional status of the study participants will be assessed before and after a 12-week yoga program.

Postmenopausal women qualifying as participants for the study are patients at the Universitätsklinik für Frauenheilkunde in Bern or are recruited through public advertisement. After giving informed consent the patients will be screened for inclusion and exclusion criteria and their biofunctional Status will be assessed. The participants of the study will then be randomly assigned to the intervention group (12 week yoga program) or to the control group. In addition to the 90 minutes yoga sessions instructed by a professional yoga teacher, the participants of the intervention group are asked to perform two yoga sessions lasting 45 minutes per week at home and document these in a diary.

After the 12 weeks the biofunctional Status of all participants of the study will be reassessed.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Women after Menopause (defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40mlU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy)
* Age over 18 years
* At least 4 hot flushes per day (examined through the Menopause rating scale MRS-II)
* No regular yoga practice for two years
* German as native language
* Willing to participate in 12 yoga classes as well as two 45 self practice sessions per week
* Willing to assess biofunctional Status and give blood samples

Exclusion Criteria:

* Acute and/or serious disease in the past two years (e.g. Cancer, major surgery)
* Autoimmune or chronic inflammatory disease (e.g. rheumatism, thyroid dysfunction)
* Mental illness (e.g. Depression or anxiety disorder (HADS \>8))
* Acute or chronic back pain or herniated vertebral disc
* Compulsion to participate in the trial
* Attendance of less than 10 yoga lessons out of 12.
* Hormone replacement therapy (HRT)
* Smoking \> 20 Cigarettes per day or over 20 packyears
* Consumption of \>30g alcohol per day (\>1 liter of beer or \>0.3 dl of wine)
* Previous periodic participation in yoga classes within the last two years
* Inability or contraindications to undergo the investigated intervention
* Participants incapable of judgement or participants under tutelage Diabetes mellitus
L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC)

The aim of this study was to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning.

The study was carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospitals, Tanta and Mansoura Universities) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent was taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data was maintained by making code numbers for each patient. The investigators planned to conduct a randomized clinical trial to evaluate efficacy and safety of LC as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients was randomized to LC or a non LC in a 1:1 ratio (25 patients in each group). LC was given IV, as a dose of 1 g/8 hours. Patients was monitored and a detailed documentation of any adverse effect due to LC therapy was recorded.

This intervention represented an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which was determined by the attending physician who maintained clinical responsibility for all patients. It consisted of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal \[1 g/Kg, orally\] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. All the patients was followed up until discharge or death. All patients was subjected to:

I. History. II. Clinical examination. III. Laboratory investigations: At admission and repeated before discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female, aged 12 years or older) with symptomatic acute phosphide poisoning (deliberate or accidental), with diagnosis made on the basis of:

The typical clinical manifestations due to and following shortly after a single exposure to phosphide.

Reliable identification of the compound based on the container brought by patient attendants or a subsequent confirmation by silver nitrate test for phosphine detection in stomach contents.

Exclusion Criteria:

* Patients less than 12 years of age Pregnant and lactating women Patients with ingestion or exposure to other substances in addition to phosphide.

Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).

Patients presenting more than 6 hours of having consumed the phosphide compound (late presenters).

Patients treated for acute phosphide poisoning in any medical center before admission
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System

The objective of this investigation is to evaluate whether pulmonary vein isolation using the VytronUS ablation system is safe and effective acutely and at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years old.
* Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.

Exclusion Criteria:

* Prior pulmonary vein isolation
* Presence of intracardiac thrombus
* Indication of inaccessible pulmonary or cardiac anatomy
* Myocardial infarction, PCI, or cardiac surgery in prior three months
* Moderate to severe valvular disease or prior valve replacement
* NYHA Class IV
* LVEF \< 40%
* Previous stroke or TIA
* Serum creatinine \> 2.5mg/dL or allergy to intravenous contrast agents
* Existing bleeding diathesis or history of complications with anticoagulation therapy
* Women who are nursing, pregnant, or trying to become pregnant
* Subjects unwilling or unable to provide consent
* Participation in a drug or device trial that would prevent completion of required study procedures
* Active implantable devices
* Major organ system disease
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.

A dose escalation trial to determine the pharmacokinetics, safety and tolerance of udenafil in male and female adolescent subjects with single ventricle physiology that that have undergone the Fontan surgical procedure. Pharmacodynamic data will also be collected to evaluate the effect of udenafil on acute exercise performance, peripheral vascular function and indices of myocardial performance. Five udenafil cohorts will be evaluated in additional to one drug free cohort

Eligibility Criteria:
Inclusion Criteria:

1. Males and females with Fontan physiology who are 14-18 years of age.
2. Willingness to return to center to complete blood draws and exercise tests as described in the study protocol.
3. Patients must agree to abstain from alcohol, caffeinated beverages, and grapefruit juice for the duration of the trial.
4. Informed assent from subject informed consent from parent/legal guardian as appropriate.

Exclusion Criteria:

1. Non-cardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
2. Height \<132 cm (minimum height requirement for exercise stress testing).
3. Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of \>4 mmHg between the regions proximal and distal to the obstruction.
4. Single lung physiology.
5. Severe ventricular dysfunction or valvular regurgitation (systemic atrioventricular or semilunar valve) determined from review of the echocardiogram performed in closest proximity to study enrollment.
6. Significant renal (serum creatinine \> 2.0), hepatic (serum aspartate aminotransferase (AST) and/or alanine aminotransferase ( ALT) \> 3 times upper limit of normal), gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications, based on laboratory assessment at the time of screening visit.
7. Hospitalization for acute decompensated heart failure within the 12 months preceding study enrollment.
8. A diagnosis of active protein losing enteropathy or plastic bronchitis.
9. Active evaluation or listing for heart transplant.
10. History of use of a phosphodiesterase type 5 inhibitor within three months of study enrollment.
11. Concurrent illness that, in the opinion of the investigator, precludes participation.
12. Current therapy with alpha-blockers or nitrates.
13. Pregnancy at the time of enrollment.
14. Latex allergy
Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the United States. In the emergent setting, patients with obstructive hydrocephalus are routinely treated with placement of an external ventricular drain. This study will compare the effect of external ventricular drainage plus intraventricular thrombolysis versus external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients with hydrocephalus from intraventricular hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Radiographic evidence of intraventricular hemorrhage with hydrocephalus
* Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2)
* Placement of an external ventricular drain with an opening pressure \>20 mm Hg

Exclusion Criteria:

* Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous malformation, or tumor
* Coagulopathy (Platelet count \<100,000, International normalized ratio \>1.5. Reversal of warfarin is permitted.)
* Age \<18 or \>75
* Pregnancy (positive pregnancy test)
* Clotting disorders
* Medical contraindications to administration of general anesthesia as determined by the attending anesthesiologist
* Medical contraindications to surgery as determined by the attending neurosurgeon
* Contraindication to recombinant tissue plasminogen activator administration:

  * Evidence of enlargening intracranial hemorrhage as evidenced by an increase in intracranial hemorrhage volume (\>5 ml) on CT obtained after EVD placement
  * Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
  * Superficial or surface bleeding, observed at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention
* Evidence of cerebrospinal infection by Gram stain or culture
* Advanced directive indicating Do Not Resuscitate or Do Not Intubate status