cyrilzakka/clinical-trials huggingface dataset:
Clinical Impact of COVID-19 by P.1 SARS-CoV-2 Lineage

Since the first report of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concern (VOC) P.1 in Manaus, Brazil, a rapid spread of this lineage across the country has been observed. Recent studies indicate that this variant is associated with higher transmissibility; it is not known whether it is associated with clinical severity and higher mortality rates.

This is a retrospective cohort study carried out at Hospital de Clínicas de Porto Alegre. Adult patients aged 18 years or more and 65 years or less who were admitted to the hospital due to symptomatic COVID-19 from June 2020 to May 2021 and had a reverse transcriptase-polymerase chain reaction (RT-PCR) cycle threshold value for either SARS-CoV-2 N1 or N2 target ≤ 25 were eligible to the study. Samples from 86 patients (43 from June 2020 to November 2020 and 43 from February 2021 to May 2021) were sequenced for further evaluation. These dates were defined since the emergence of P.1 lineage in late January.

Clinical data regarding ventilatory support, date of onset of symptoms, laboratory findings and mortality were collected from each patient. This retrospective cohort aims to assess whether the number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms differs among patients infected with the P.1 SARS-CoV-2 variant and those infected with other variants.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 65 years
* Hospital admission due to symptomatic COVID-19
* RT-PCR was collected from June to November 2020 or from February to May 2021

Exclusion Criteria:

* Patients admitted for reasons other than COVID-19
* Asymptomatic patients with positive routine screening with RT-PCR
* Patients transferred from other institutions
Imaging to Improve Brain Stimulation

This study investigates how brains change as a result of a treatment for depression called repetitive transcranial magnetic stimulation (rTMS). People who receive rTMS will have pictures of their brains and brain activity taken by a magnetic resonance imaging (MRI) scanner before and after their treatment, as well as up to three times during the six-week treatment course. These images will be examined to see if the rTMS is placed correctly to help treat their symptoms, and what changes in brain activity are happening during the rTMS treatment

Veteran patients can be referred to receive a Neuromodulation Clinic consult at the Providence VA Medical Center (PVAMC). Following this consultation, patients who are to begin rTMS therapy for the treatment of major depressive disorder (MDD) will be recruited to participate in this study. About 1 week prior to the scheduled beginning of rTMS therapy, research participants who provide informed consent will complete baseline neuropsychological measures. Within a few days of completing these measures, and before beginning rTMS therapy, participants will receive an MRI scan, including structural and functional imaging. Participants will have a similar set of MRI scans up to three times during the course of rTMS therapy, and complete neuropsychological measures at these scanning sessions. A final MRI scan will be conducted within a week of completing the rTMS therapy course, and neuropsychological measures will be completed at this session.

Eligibility Criteria:
Inclusion Criteria:

* Veteran beginning TMS therapy for the treatment of MDD at the Providence VAMC Neuromodulation Clinic
* Age between 18 and 80 years
* Able to read, verbalize, understand, and voluntarily sign the informed consent form
* Structured Clinical Interview for DSM-5 (SCID-5) confirmed diagnosis of MDD

Exclusion Criteria:

* Contraindications to MRI (e.g. implanted metal or electronic devices)
* Montreal Cognitive Assessment (MoCA) score \< 26
* Pregnant
Arthralgia of the Temporomandibular Joint. Pain Relief Following One Intra-articular Injection of Methylprednisolone

The hypothesis is that a single dose intra-articular injection of corticosteroids are effective in relieving temporomandibular arthralgia pain.

The purpose of the study is therefore to evaluate the effect of a single dose intra-articular methylprednisolone vs. placebo in a month perspective on subjects with unilateral arthralgia of the TMJ.

This is a randomized blinded multicenter controlled study on 64 subjects (18 years or older) with the diagnosis of unilateral arthralgia of the TMJ.

The subject visit the clinic at three occasions; one enrollment visit, one baseline treatment visit and one evaluation visit one month after baseline.

One week after baseline a follow-up telephone call is made with the purpose to track adverse events.

Pain questionaries are completed morning, lunch and dinnertime during three days before treatment, five days after treatment and three days proceeding the evaluation visit.

The study ís planned to commence 10th December 2013 and last patient out 15th January 2015.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or above
* the diagnosis arthralgia in one TMJ
* understands Swedish both verbally and in written
* signed informed concent

Exclusion Criteria:

* TMJ sounds in terms of clicking (crepitation allowed))
* polyarthritis/connective tissue disease
* bilateral TMJ arthralgia
* fibromyalgia or other generalized pain
* ongoing infection
* ongoing dental treatment
* intra-articular corticosteroid injection of a TMJ the past 6 months
* previous surgery of the affected TMJ
* complex psychiatric/psychologic status
* institutionalized living including prisoners
* staff at the investigational clinic
* hypersensitive to local anesthetics
* hypersensitive to methylprednisolone
* hemophilia
* methemoglobinemia
* nursing
* compromized health status according to the judgment of the investigator
* concommitant use of the drugs cyclosporine, erythromycin, pentobarbital, itraconazole, ketoconazole, Rifampicin, Acetylsalicylic acid, Oral anticoagulant
* mentally retarded
A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Myelofibrosis Through Chart Review

Myelofibrosis (MF) is a rare blood cancer, characterized by extensive fibrosis (scarring) of the bone marrow. It is one of a group of cancers known as myeloproliferative neoplasms (MPNs) in which bone marrow cells that produce blood cells develop and function abnormally. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with Myelofibrosis.

Data from approximately 1000 participants will be collected. No participants will be enrolled in this study.

Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 156 weeks.

There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 156 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Treated for myelofibrosis (MF) \[primary myelofibrosis (PMF) and secondary myelofibrosis (SMF)\].
* Must have initiated their first treatment on or after the first date when ruxolitinib was approved in their country of residence and no later than 31 December 2021.

Exclusion Criteria:

- Having received MF treatment in a clinical trial setting.
Effect of CRP and SAA Point-of-care Testing on Antibiotic Prescribing for Acute Respiratory-tract Infections

The study was a practical, cluster-randomized controlled trial to evaluate the impact of CRP and SAA point-of-care testing (CRP\&SAA POCT) on antibiotic prescribing in patients with acute respiratory-tract infections (ARI) at primary care facilities in rural China.

The study was a practical, cluster-randomized controlled trial to evaluate the impact of CRP and SAA point-of-care testing (CRP\&SAA POCT) on antibiotic prescribing in patients with acute respiratory-tract infections (ARI) at primary care facilities in rural China. The study includes two arms, in which CRP\&SAA POCT will be provided in 20 village clinics in the intervention arm. Additional physician training on the use of CRP\&SAA POCT (including centralized training, distribution of physician training manuals, and desk reminders) and patient education sheets (to help patients understand the help of CRP\&SAA POCT in guiding their care) will also be provided；The control arm will not receive any intervention and will serve as the control (usual care). The primary outcome is the proportion of patients who are diagnosed with ARIs and prescribed antibiotics during their initial visit (defined as no prescription record at the current institution within the preceding 14 days) in both study arms.

Eligibility Criteria:
Eligibility criteria for clusters Village clinics with an annual outpatient volume exceeding 2000, an average of 10 or more patients per week presenting with ARIs, and licensed prescribers are considered eligible for selection for the intervention. Annual outpatient prescriptions and average weekly visits for ARIs will be verified by obtaining prescription data from all village clinics for the previous year, as documented in the information section of the local health board.

Eligibility criteria for participants The target population of this study included (1) patients of all ages diagnosed by a village doctor with ARIs (including upper and lower respiratory infections); and (2) patients who present with ≥1 acute respiratory symptoms (including cough, rhinitis (sneezing, nasal congestion or runny nose), sore throat, shortness of breath, wheezing or abnormal auscultation). Patients with non-respiratory diseases or those with severe clinical symptoms requiring referral to a higher-level institution are excluded from the target population.
Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is ≥18 years of age;
2. Participant has been diagnosed with hidradenitis suppurativa as determined by the investigator and has a history of signs and symptoms of hidradenitis suppurativa dating back at least 6 months prior to the Screening Visit;
3. Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5;
4. Participant has hidradenitis suppurativa lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (i.e., be Hurley Stage II or III);
5. Participant had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion;
6. Participant must be, in the opinion of the investigator, at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information.

Exclusion Criteria:

1. Participants with known hypersensitivity to sonelokimab or any of its excipients;
2. Participants with known hypersensitivity to adalimumab or any of its excipients;
3. Participant has a draining fistula count of ≥20 at the Screening Visit;
4. Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa;
5. Prior exposure to more than 2 biologic response modifiers;
6. Participant has a diagnosis of ulcerative colitis or Crohn's disease.
A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19)

The purpose of the study is to determine if Convalescent anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Methylene Blue Treated (MBT) plasma plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the intensive care unit (ICU) through Day 29.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are being treated in the intensive care unit (ICU) for COVID-19 for not longer than 48 hours or for whom a decision has been made that COVID-19 disease severity warrants ICU admission.
* Subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides informed consent (ICF) prior to initiation of any study procedures.
* Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase \[RT\]-PCR), or other commercial or public health assay in any specimen during the current hospital admission prior to randomization.
* Illness (symptoms) of any duration, and the following:

  1. Radiographic infiltrates by imaging (chest x-ray, computerized tomography \[CT\] scan, etc.), and
  2. Requiring mechanical ventilation and/or supplemental oxygen
* Subjects with no limitation of therapeutic effort (decision on the status and future of the subject).
* Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline Visit.

Exclusion Criteria:

* Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
* The subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product or methylene blue.
* A medical condition in which the infusion of additional fluid is contraindicated.
* Shock unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed.
THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study

A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.

The purpose of this study is to measure the long term effectiveness，clinical benefit, and safety outcomes of catheter ablation with STSF and AI for paroxysmal atrial fibrillation (PAF) subjects up to 12-month follow-up.

Subject:Up to 150 PAF subjects will be included in the study data, representing all consecutive subjects having catheter ablation with AI guiding STSF and for the treatment of PAF at the site.

Primary endpoint: The primary endpoint is freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.

Secondary endpoint : Acute success at 0.5hour CPVI (i.e. entrance block achieved in all veins, verified via an isoproterenol intravenous challenge)

* Numbers of reconnected pulmonary veins (PV), with number and location of any gaps
* Procedural efficiency measures（e.g. mapping time, ablation time, total procedure time, and fluid volume delivered via catheter.
* AI values
* Inter-Tag distances
* Adverse events (Complications related to device or procedure)
* Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year Clinical Study Sites: Shanghai General Hospital Study Duration: 18-month enrollment period, with follow-up at 3, 6 and 12 months after ablation, with a blanking period defined as the period within 90 days after the ablation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment
3. Able and willing to comply with all pre-, post- and follow-up testing and requirements
4. Able to sign EC-approved informed consent form

Exclusion Criteria:

1. AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause
2. Patient has AF episodes lasting longer than 7 days
3. History of heart surgery, or any previous ablation for AF
4. Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
5. Documented left atrial thrombus on imaging
6. New York Heart Association (NYHA) class III or IV heart failure
7. Hypertrophic obstructive cardiomyopathy
8. Presence of implantable cardioverter defibrillator (ICD)
9. Contraindication to isoproterenol
10. Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
11. Women who are pregnant and/or breast feeding
12. Enrollment in an investigational study evaluating another device, biologic, or drug
Liraglutide for HIV-associated Neurocognitive Disorder

This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.

HIV, insulin resistance and type 2 diabetes mellitus (DM) are independently associated with cognitive impairment. Considering the synergistic effects of HIV and DM on cognition, these subjects are at increased risk of cognitive impairment. glucagon-like peptide 1 (GLP-1) receptors have wide tissue distribution including the central nervous system. The study hypothesis is that GLP-1 could potentially ameliorate the impairments in cognition in this population. This study will assess the impact of liraglutide on neurocognitive performance and peripheral inflammatory markers. It will also evaluate the effects of liraglutide on glycemic control and metabolic risk factors in HIV infected subjects with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* HIV controlled on therapy for at least 12 weeks
* Viral load \< 200 copies
* BMI \>27 to 45
* Diagnosis of DM type 2 with A1-C \>7 to 15
* Participants must be willing to comply with all study related procedures

Exclusion Criteria:

* Personal or family history of pancreatitis
* Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
* Gastroparesis
* Allergy to liraglutide or any of the active ingredients in liraglutide or other GLP-1 analogue
* Weight loss drugs other than metformin
* Type 1 diabetes mellitus or diabetic ketoacidosis
* Known major cognitive deficit dementia, history of head trauma with loss of consciousness \>30 min, history of stroke, current central nervous system (CNS) disorder such as seizures or opportunistic CNS infection
* Renal insufficiency defined as creatinine clearance \< 60 mL/min
* Active opportunistic infections
* Pregnancy or breastfeeding
* Unstable cardiovascular disease with hospitalization within 1 year for acute coronary syndrome
* Decompensated heart failure
* Substance abuse
* Active alcohol or opioid substitution therapy
* Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation
Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy

Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy


Eligibility Criteria:
Inclusion Criteria:

* paroxysmal atrial fibrillation, symptomatic

Exclusion Criteria:

* atrial fibrillation other than PAF, asymptomatic, previous AF ablation
Intraoperative Indocyanine Green Laser Angiography; Postoperative Outcomes for Autologous Tissue Flaps

The purpose of this study is to identify and compare complication rates between autologous breast reconstruction techniques with and without the inclusion on intraoperative indocyanine green (ICG) angiography.

ICG-angiography is a real-time visualization of tissue perfusion using intravenous fluorescence. It allows the surgeon a tool for intraoperatively assessment of tissue perfusion of the autologous flap, providing a basis for trimming of hypo perfused areas. The study evaluates the effect of inclusion of this technique by examine postoperative outcomes retrospectively. This is done by differentiation between major and minor complications to evaluate the greatest gains of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients over the age of 18 years
* Deemed suitable for breast reconstruction with the latissimus dorsi (LD) myocutaneous flap, muscle sparring LD flap or transverse rectus abdominal muscle (TRAM) flap

Exclusion Criteria:

* Patients with recurrence of breast cancer
* Smoking 4 weeks prior of operation
* Not able to read and understand Danish
Attain Performa(TM) Quadripolar Lead Study

The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.


Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for implant of a CRT-D device and left-heart lead per local indications (In US only this is based on Class I and II indications for CRT-D implant per HRS/ACC/AHA guidelines)
* Patient (or legally authorized representative) has signed and dated the study-specific Consent Form
* Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
* Patient is expected to remain available for follow-up visits
* Patient understands the study and agrees to comply with study protocol

Exclusion Criteria:

* Patient has a previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt
* Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
* Patient has had a heart transplant (Note: Patients waiting for heart transplants are allowed in the study)
* Patient is contraindicated for \< 1 mg dexamethasone acetate
* Patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (Note: Co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from Medtronic's study manager)
* Patient has a life expectancy less than 180 days
* Patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)

  * In US, women of childbearing potential must have a negative pregnancy test 7 days prior to implant to be included
* Patient is unable to tolerate an urgent thoracotomy