cyrilzakka/clinical-trials huggingface dataset:
High Flow Nasal Cannula Versus High Velocity Nasal Insufflation in Covid-19

To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure as regard need for mechanical ventilation, changes of arterial blood gases (ABG) parameters, duration of ventilatory support and delay between admission and intubation

novel clinical syndrome caused by a previously unknown coronavirus, SARS-Cov-2, was first identified in Wuhan (China) in December 2019. Despite massive efforts to contain viral transmission, a worldwide epidemic has developed from this virus. This disease is presently known as COVID-19 COVID-19 pandemic reached over 45 million confirmed infections and claimed the lives of more than 1.2 million people worldwide. The clinical features of COVID-19 are diverse and range from asymptomatic to critical illness and death. Severe and critical cases represented 14% and 5% of laboratory-confirmed COVID-19 patients and need ICU admission Several non-invasive options exist to support COVID-19 patients with mild or moderate respiratory distress and may reduce the numbers of patients requiring intubation, mechanical ventilation in some severely ill patients such as High flow nasal oxygen (HFNO) High flow nasal oxygen (HFNO) includes high flow nasal cannula and high velocity nasal insufflation. High flow oxygen systems provide oxygen-rich heated humidified gas to the patient's nose at flow levels sufficient to deliver a constant, precisely set high FiO2. Exhalation is to the open air. HFNO reduces dead space, provides low levels of PEEP, and decreases breathing frequency and work of breathing HFNC flow rates reach up to 60 L/min, whereas HVNI delivers flow rates up to 40 L/min due to differing mechanisms of delivery (4).

High velocity nasal insufflation (HVNI) utilizes a small-bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive by RT-PCR
* Age≥ 18 years
* Both gender
* Classical radiological lesions of COVID-19 on HRCT chest.
* Respiratory rate \> 30/ min and not responding to non-rebreather masks.
* COVID-related pneumonia requiring non-invasive ventilatory support (high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP)

Exclusion Criteria:

* Age \< 18 years
* Patients who refuse to participate in the study
* Severe respiratory failure requiring invasive ventilatory support
* Indication of immediate tracheal intubation
* Significant acute progressive circulatory insufficiency
* Impaired conscious level
* Nasal blockade
Trochanteric Bursal Repair After a Total Hip Replacement - Are There Benefits During the First 90 Days

During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is generally recommended for removal as it facilitates the surgical approach. However, recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may protect against infections. The aim of this study is to evaluate the differences in infection rates, wound complications, deep gluteal syndrome presence, pain, and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not, and to provide recommendations regarding bursal repair.

During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is typically recommended for removal as it facilitates the surgical approach. However, recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may provide protection against infections. The aim of this study is to evaluate the differences in infection rates, wound complications, deep gluteal syndrome presence, pain, and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not, and to provide recommendations regarding bursal repair.

This research will be a prospective randomized controlled trial with patients subjected to sequential randomization. One group of patients will undergo the routine excision of the bursa during surgery, referred to as Group 1. In the other group, the trochanteric bursa will be carefully retracted and subsequently repaired in its anatomical location beneath the fascia after the surgical procedure. Wound closure will be performed routinely, with subcutaneous and skin closure. All patients will have a Hemovac drain placed, and they will follow the same rehabilitation protocol.

Patients will be evaluated on postoperative days15, 30, and 90 using Visual Analog Scale scores, and on days 30 and 90 using the Harris Hip Score. Additionally, patients will be assessed for tenderness on palpation, the presence of hip snapping (a sensation of the hip catching), hemoglobin drop, 90-day infection rates, and the presence of deep gluteal syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 to 90 years of age
* With a diagnosis of primary hip osteoarthritis
* Willing to be included in the study

Exclusion Criteria:

* Patients who had a known history of trochanteric bursitis, deep gluteal syndrome, sciatica, vertebral fracture, hip fracture, hip arthroscopy, and core decompression surgery
* Patients who had a history of bursal injection within 6 months
* Patients undergoing hip arthroplasty with a shortening osteotomy
Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis

The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.

The purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. Eligible patients will be randomized 1:1 and the treatments will be administered for 24 weeks. Clinical efficacy at the end of treatment will be evaluated. Safety will be evaluated through adverse events recoding during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Patient \>= 45 years .
* Primary OA of the knee according to ACR criteria.
* OA radiological grade II-III according to Kellgren and Lawrence.
* Patients with moderate-severe pain.

Exclusion Criteria:

* Patients with clinical significant trauma or surgery in the target knee.
* Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease or fibromyalgia.
* Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
* Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections.
* Clinical diagnosis established of uncontrolled diabetes mellitus.
* Patients with asthma.
* History of hypersensitivity to the active drugs or any excipients of the formulations.
PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5

Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate burden among gay, bisexual, and other MSM in major centers such as Toronto. Pre-exposure prophylaxis (PrEP) with oral, daily tenofovir/emtricitabine (TDF/FTC, Truvada®) is a novel biomedical approach to HIV prevention shown in the iPrEx trial to be safe and efficacious in reducing HIV acquisition by 44% among MSM, when provided in a comprehensive package of HIV prevention interventions including counseling, testing/treatment of sexually transmitted infections (STIs), and condoms. There is now widespread mobilization to assess the feasibility of PrEP roll-out worldwide, with urgent calls for 'demonstration projects' addressing real-world PrEP implementation issues.

PREPARATORY-5 is Canada's first PrEP demonstration project, and will examine real-world PrEP implementation issues including acceptability, effectiveness, impact on sexually transmitted infections, and strategies for supporting adherence outside the clinical trial setting. The investigators have also established a comprehensive community-based research program investigating the role of community-based organizations in PrEP implementation and delivery.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified man who has sex with men
* Age 18 years or older
* Able to communicate in both written and oral english
* HIRI-MSM score greater than or equal to 10
* At least one self-reported unprotected receptive anal sex act over the preceding 6 months
* Creatinine clearance greater than or equal to 60mL/min by Modified Diet in Renal Disease (MDRD) formula
* HIV un-infected at screening using standard ELISA and Western Blot testing

Exclusion Criteria:

* Clinical signs or symptoms suggestive of an HIV seroconversion illness within the last 3 months in the opinion of the investigator
* Use of pre- or post-exposure prophylaxis within the last 3 months
* Use of concomitant nephrotoxic drugs
* Use of concomitant immune modulatory drugs
* Hepatitis B surface antigen positivity
* Any condition or concomitant medication portending an increased risk of osteoporosis
* Enrollment in any other HIV prevention program or trial
Using the Objective Physiological Parameters to Test TCM Syndrome in Sub-health Subjects

Background: Suboptimal health status (SHS) is a dynamic state potential clinical stage or prior psychosomatic disease stage during which people have not been diagnosed with a disease, but they have risk factors for illness and have tendency to develop diseases. The term refers to an existing condition of ill health that could lead to a pathologic condition but could also be eliminated, enabling the individual in question to return to a state of good health. Traditional Chinese medicine (TCM) emphasizes the importance of health care and the idea that preventive treatment for diseases is superior to curative treatment. Therefore, early TCM-based intervention can improve the health status of people with SHS. People with SHS often experience such nonspecific symptoms as fatigue; such symptoms are typical of SHS from the perspective of TCM. The present study investigated people with SHS and fatigue as their primary symptom. All enrolled participants completed a physical questionnaire, after which their physiological parameters were monitored using a cloud physiological signal monitoring system to investigate correlations with TCM patterns. Methods: The participants first completed a body constitution questionnaire, the WHO Quality of Life questionnaire, the SHSQ-25 questionnaire, the Epworth Sleepiness Scale, and the Pittsburgh Sleep Quality Index, and subsequently underwent sphygmography to determine their pulse patterns. Analyses of pulse waves were presented in relation to the spectral energy ratio (SER), and SER10 scores represented subtle changes in internal organ blood flow; 13-50-Hz spectrum analysis for pulse delineated any flow energy deviation in organs.


Eligibility Criteria:
Inclusion Criteria:

* Fatigue combined with one or more of the following symptoms of insomnia and higher dreaming frequency, irritability and short temperedness, forgetfulness, chest tightness, lack of concentration, or loss of memory (assessed using the Suboptimal Health Status Questionnaire-25 \[SHSQ-25\]).
* Body mass index (BMI) between 25 and 30 kg/m2.
* Resting blood pressure measured as 130-139/80-89 mmHg on more than three occasions in 1 week.
* SHSQ-25 score of ≧35

Exclusion Criteria:

* Individuals diagnosed as having a chronic condition by Western medicine, including hypertension, diabetes, chronic hepatitis, chronic kidney disease, chronic hyperlipidemia, and coronary heart disease.
* Individuals diagnosed as having a mental illness by Western medicine.
* Individuals diagnosed with cancer.
A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
* Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:

  * either diet/exercise alone or
  * up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Exclusion Criteria:

* Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
* Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
* Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
* Have had a history of chronic or acute pancreatitis.
Impacts of a Physician-targeted Price Transparency Tool on Medication Out-of-pocket Costs

The goal of this study is to evaluate whether presenting patient out-of-pocket cost information to the provider at the time of prescribing leads to orders for medications with lower out-of-pocket costs. The Real-Time Prescription Benefits (RTPB) tool has been implemented to randomly selected providers across NYU Langone Health's outpatient physician practices. The RTPB tool provides physicians with information about patient out-of-pocket (OOP) cost for medications at the point of outpatient prescribing. OOP is inclusive of any copay, coinsurance, and deductible that the patient owes given their prescription drug benefit plan. If the physician is submitting a prescription order and a clinically-appropriate alternative with a lower OOP cost is available, an alert with OOP cost information for the drug being initially ordered as well as up to three lower-cost alternatives will be displayed. Implementation of this tool will be analyzed to see if it will lead to reduced out-of-pocket costs on ordered medications when alternatives were available. Because effects could vary along many dimensions (e.g., specialty, drug class, insurance type), secondary analyses will be conducted and stratified along such dimensions. Analyses will be conducted at the prescription order level.


Eligibility Criteria:
Inclusion Criteria:

* Medication orders for which this match and query was successful and outcomes data was available.

Exclusion Criteria:

* No patient-level exclusion criteria will be imposed
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules

A prospective, two-center, single arm phase II clinical study to evaluate safety and effectiveness of ablation therapy in the treatment of lung cancer presenting as ground-glass nodules


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 85 years;
2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
3. The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
4. For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm
5. The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest
6. The patient is able to understand and comply with the study and has provided written informed consent

Exclusion Criteria:

1. Patients who participated in any drug and / or medical device clinical trials within one month before the trial
2. had severe disease conditions
3. allergy to narcotic drugs
4. had other autoimmune disease
5. dementia or cognitive impairment can't cooperate with researchers
6. any local treatment other than ablation was received within 4 weeks before the study
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma

This study will assess the safety, tolerability, pharmacokinetics (PK) and the therapeutic potential of HDP-101 in patients with plasma cell disorders including multiple myeloma.

The study will consists of two parts: a Part 1 dose escalation phase and a Part 2a expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study will enroll subjects with relapsed/refractory MM or other plasma cell disorders expressing BCMA. An adaptive 2-parameter Bayesian logistic regression model (BLRM) for dose-escalation with overdose control will be used in the dose-escalation phase for determination of the MTD or the RP2D. Dose-expansion phase of the study aims to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as a monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 years.
* Life expectancy \>12 weeks.
* Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.
* A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
* Must have undergone SCT or is considered transplant ineligible.
* Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator.
* Measurable disease as per IMWG criteria.
* Adequate organ system function as defined in protocol.

Exclusion Criteria:

* For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.
* Known central nervous system involvement.
* Plasma cell leukemia.
* History of congestive heart failure.
* Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.
* Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.
* Radiotherapy within 21 days prior to the first study treatment infusion.
* History of any other malignancy known to be active.
* Known human immunodeficiency virus infection.
* Patients with active infection requiring systemic anti-infective.
* Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen.
* Patients with positive test results for hepatitis C virus (HCV) infection.
* Current active liver or biliary disease.
Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes

AF lactate level could help in predicting the duration from ROM till delivery


Eligibility Criteria:
Inclusion Criteria:

1. women with PPROM
2. GA between 24 to 34 weeks

Exclusion Criteria:

1. chorioamnionitis
2. previous Preterm labor
3. abruptio placentae
4. UTI ,pyelonephritis
Comparison of Intravitreal Ranibizumab and Macular Grid-pattern Laser for Treatment of Diabetic Macular Edema

This study investigates the hypothesis that ranibizumab injection given into the eye is an efficacious and safe treatment option applied for swelling of the macula (site of sharp vision) in diabetes.

This is a randomized, controlled, three-center trial to assess the efficacy and safety of intravitreal ranibizumab injections in diabetic macular edema. Comparator arm consists of patients receiving macular grid-pattern laser therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female type I or II diabetic patients over 18 years of age
* Diagnosis of DME secondary to diabetic retinopathy and decrease in vision is due to DME and not due to other causes in the opinion of the investigator
* Patients who have a BCVA score between 78 and 39 letters in the study eye using ETDRS-like visual acuity charts at a testing distance of 4 meters
* Expectation by the investigator that patient will potentially benefit from laser treatment or ranibizumab treatment
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Active intraocular inflammation, any active infection or history of uveitis
* Uncontrolled glaucoma or neovascularization of the iris in the study eye
* Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
* Concurrent disease in the study eye that could compromise visual acuity or prevent the improvement of visual acuity (including diabetic proliferative retinopathy) or require medical or surgical intervention during the study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause
* Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
* Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) or intravitreal corticosteroids in the study eye within 3 months prior to randomization
* Any intraocular surgery in the study eye within 3 months prior to randomization
* History of vitrectomy in the study eye
* Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids
* Pregnancy and lactation