cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Diagnostic to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Brazil

Th objectives of this study are:

* To determine the performance of G6PD tests in detecting G6PD activity and hemoglobin (Hb) compared to a reference assay
* To assess the comprehension of the G6PD test packaging and labelling among intended users
* To assess the usability of G6PD test result outputs among intended users

This is a cross-sectional diagnostic accuracy study that includes both participants and health worker participants.

The participant population will be recruited at clinics and through a household survey using an enriched sample of a population with known G6PD status, established through previous epidemiological studies. Clinic staff will take capillary blood samples and conduct two point of care (POC) tests: 1) HemoCue® hemoglobin test, and 2) the investigational Standard Diagnostics (SD) Biosensor STANDARD POC test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. Venous blood will be collected and transferred to a laboratory where reference assays will be performed on venous samples using the Pointe Scientific G6PD Analyzer and hemoglobin tests.

The health worker participants will include trained intended users of the G6PD tests. Trained health workers will be surveyed to assess product usability through a questionnaire to assess label and packing comprehension as well as results interpretation.

Eligibility Criteria:
1. Participants with unknown G6PD status

   Inclusion criteria:
   * Febrile patients seeking care at the Manaus or Porto Velho clinics
   * 2 years age or older
   * Willing to provide informed consent

   Exclusion criteria
   * Younger than 2 years of age
   * Participants who received a blood transfusion in the last 3 months, self report
   * Unwilling to provide informed consent
2. Participants with known G6PD status

   Inclusion criteria:
   * Included in previous G6PD surveys and provided consent to be contacted again
   * 2 years of age or older
   * Willing to provide informed consent or assent

   Exclusion criteria:
   * Younger than 2 years of age
   * Participants who received a blood transfusion in the last 3 months, self report
   * Unwilling to provide informed consent or assent or unavailable during study visit
3. Health workers

Inclusion Criteria:

* Provides malaria case management at study facility or study site
* Considered an intended user of quantitative POC G6PD tests
* Trained and proficient in the use of the POC G6PD test
* Willing to provide informed consent

Exclusion Criteria:

* Does not provide malaria case management at study facility or study site
* Not considered an intended user of quantitative POC G6PD tests
* Not trained or not proficient in the use of the POC G6PD test
* Unwilling to provide informed consent
Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Canada

The purpose of the study is to collect images data sets from clinical cases and periodic user feedback on the Next Generation Venue ultrasound system under clinical conditions. This is a medical device study designed as a clinical, open label, unblinded, non-randomized, prospective, feasibility research study.

Adult patients (aged \>18 years) will be enrolled as they present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), cardiac care unit (CCU), and/or other departments. Subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. Eligible subjects will undergo an ultrasound exam using the investigational ultrasound device. The exam type will be based on the subject's clinical condition. Users performing the scans will periodically be asked to provide feedback on User Survey forms prepared by the Sponsor. Image data sets from investigational exam will be stored electronically and de-identified data will be disclosed to the Sponsor.Results are for use in development and optimization of a next generation ultrasound system being developed by study Sponsor, GE Healthcare (GEHC) prior to future commercial release.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (aged 18 years of age or older) at the time of consent;
2. Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning); AND
3. Able and willing to provide written informed consent for participation.

Exclusion Criteria:

1. Are pregnant subjects;
2. Require procedures that cannot be readily completed using available investigational devices; OR
3. Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.
Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lower abdominal surgery.

Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol 1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam group). Additionally pain was treated postoperatively using morphine patient-controlled analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* lower abdominal surgery

Exclusion Criteria:

* body weight more than 150% of their ideal body weight
* history of significant cardiac, pulmonary, renal, hepatic or hematological disease; chronic drug or alcohol abuse; hypersensitivity to any of the studied drugs; bronchial asthma; gastritis or peptic ulcer; and pregnancy
* patients who received any analgesic drug a day before surgery
Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly

This study will compare the effects of cooked, ground beef to those of beef protein isolate on blood and muscle proteins.

STUDY OBJECTIVES Primary: To compare the effects of consumption of a 3-ounce serving of beef to that of a 20g serving of BPI on skeletal muscle synthetic and breakdown rate in healthy elderly subjects.

Secondary: To investigate the effect the study products on plasma levels of amino acids, insulin, and glucose in healthy elderly subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female.
* Age 60 years or older.

Exclusion Criteria:

* Any (history of) gastrointestinal disease that interferes with GI function
* Diagnosed and active treatment of Diabetes Mellitus type I or II
* History of congestive heart failure
* Recent (6 months) hospitalization for heart disease treatment or management (e.g. PTCA, stent, surgery)
* Myocardial infarction in the past year
* Infection or fever in the 7 days prior to enrollment
* Current use of corticosteroids, growth hormone, or testosterone
* Adherence to a weight loss diet
* Use of protein-containing or amino acid-containing nutritional supplements within one week of enrollment
* Current alcohol (\>7 ETOH per week) or drug abuse
* Platelet count (PLT) \< 100,000
* History of hypo- or hyper-coagulation disorders including use of a coumadin derivative
* Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical indication)
* Allergy to local anesthetic
* Blood hemoglobin \< 9.0 g/dL
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Cardiac Health, Mood, & Neuroimmune Activation

The study is designed to find out more about how mood and the nervous system affect the body's immune system. The investigators plan to study this in people who have been identified by their physician as being at-risk for the development of heart failure. There will be approximately 525 individuals participating in this study at UCSD and at the VASDHS. Individuals who will be asked to take part in this study will have a functional or structural heart problem apparent on an echocardiogram, or a previous heart attack, but no symptoms of heart failure. Some individuals will only complete one assessment (consisting of psychological questionnaires and interview, walk test, blood draw, and body measurements), whereas others deemed "high-risk" on the basis of a laboratory test, will be asked to complete that same assessment every 6 months for the duration of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Age range 18 years or older
2. ACC/AHA classification Stage B HF patients
3. Receiving optimal treatment according to their cardiologist and/or internists
4. An echocardiogram within the past 12 months
5. Ejection fraction: as described below in Initial Screening and Identification of Stage B Patients
6. Men and women of all ethnicities and races
7. Ability and physician clearance to perform mild exercise
8. With and without depressive symptoms and DSM-IV MDD
9. Ability to fully understand all elements of and sign the written informed consent before initiation of the study

Exclusion Criteria:

1. History of recent myocardial infarction (3 months)
2. Significant aortic or mitral stenosis, angina not adequately managed with nitrates
3. Coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 2 months
4. Hypertension \>180/110 mm Hg
5. Recent stroke or significant cerebral neurological impairment
6. Severe COPD, patients who require mechanical ventilation, with cardiogenic shock, volume depletion
7. Subjects with high suicide risk
8. Immune-related disorders including infectious diseases and autoimmune and inflammatory disorders
9. Morbid Obesity: BMI \> 40 due to likelihood of inability to perform exercise
10. Women who are pregnant or nursing
11. Major mental illness as determined by referring provider
Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine

The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Main outcomes will be glucose levels during OGTT, insulin secretion and pancreatic beta cell function measured by the disposition index derived from the OGTT.

Randomization and masking. Patients will be randomly assigned in a 1:1 ratio to receive linagliptin/metformin 2.5/850mg every 12 h + lifestyle modification program, or metformin 850mg every 12 h + lifestyle modification program during 6 months. Randomization will be performed using an electronic random numbers table by a Nutritionist not involved in the study. Participants and investigators involved in the patients follow-up and outcome measurements will be masked to treatment allocation during the entire study.

Patients will have a follow-up visit every month. Every appointment is about 30-45 minutes; medications tolerance and side effects will be recorded in every patients´ visit. Nutritional and physical activity assessment according to the patient´s weight will be performed by a Nutritionist every month. Monthly adherence to medications will be evaluated by pill counting; nutritional adherence and energy intake will be evaluated at 6 months by a food frequency questionnaire, and physical activity at 0 and 6 months. At basal and at 6 months patients will have an OGTT. Primary objective is to evaluate at 6 months glucose profile during OGTT, insulin secretion and pancreatic β-cell function by the OGTT DI, and regression to normoglycemia; T2D will be diagnosed and confirmed by at least two consecutive measurements of the same criteria: glycated haemoglobin ≥ 6.5 %, fasting glucose ≥ 126mg/dl, or 2 h glucose ≥ 200 mg/dl.

Eligibility Criteria:
Inclusion Criteria:

* Patients with impaired glucose tolerance (2 h glucose between 140 - 199 mg / dL) that after 1 year of treatment with metformin at a dose of 1700 mg daily + lifestyle modifications don't achieve normoglycemia.
* Patients who accept to participate in the study and sign informed consent.

Exclusion Criteria:

* Patients with type 2 Diabetes diagnosted previuosly or detected during the OGTT
* Serum creatinine \> 1.6 mg/dL
* Hypertriglyceridemia very high (\>500 mg/dL)
* Pregnancy
* Systolic blood pressure \> 180 mmHg or Diastolic blood pressure \>105 mmHg (patients could be re-screened after blood pressure control)
* Excessive alcohol intake, acute or chronic
* Medications or medical conditions that affect glucose homeostasis (thiazides, beta blockers, glucocorticoids for systemic use, weight-reducing drugs or anorexigenics, Cushing's syndrom, Thyrotoxicosis.
The Application Value of Deep Learning-Based Nomograms in Benign-Malignant Discrimination of TI-RADS Category 4 Thyroid Nodules

This retrospective study focuses on benign and malignant classification of thyroid nodules using deep learning techniques and evaluates the value of deep learning based nomograms in the classification of TI-RADS category 4 thyroid nodules to improve the accuracy of benign and malignant identification of TI-RADS category 4 thyroid nodules.

Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.


Eligibility Criteria:
Inclusion Criteria:

1. Ultrasound-confirmed diagnosis of thyroid nodules that are classified as TI-RADS category 4.
2. Availability of pathological results.

Exclusion Criteria:

1. Lack of pathological diagnosis.
2. History of thyroid surgery or other treatments.
3. Poor quality of ultrasound images of thyroid nodules.
4. Incomplete clinical and imaging data of the patient.
Golimumab Plus UVB-311nm in Psoriasis

Golimumab, a TNF-alpha antibody, has been approved in the EC and USA for the treatment of psoriatic arthritis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic skin lesions in golimumab-treated patients.

Psoriatic skin lesions of patients with psoriatic arthritis who receive standard treatment with golimumab (50 mg or 100 mg s.c. once a month depending on total body weight whether below or above 100 kg, respectively) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to \< 3). A patient qualifies if A) golimumab was started within a week or B) after 3 months of golimumab treatment the PASI reduction is smaller than 90%. PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. The primary hypothesis is that phototherapy increases the PASI reduction on the exposed body site by more than 20%. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fisher exact test is applied to determine differences in complete remission, PASI reduction \> 90%, \> 75% and/or 50% between body sites.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients with psoriatic arthritis who receive treatment with golimumab
* Patient wish for treatment of psoriatic skin lesions

Exclusion Criteria:

* Pregnancy or lactation
* Presence and/or history of malignant melanoma
* Presence and/or history of invasive squamous cell carcinoma of the skin
* Presence and/or history of more than 3 basal cell carcinomas
* Dysplastic nevus syndrome
* Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
* Autoimmune disorders such as lupus erythematosus or dermatomyositis
* Abnormal photosensitivity and photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
* General poor health status
Effect of Dental Waterjet on Oral Hygiene for Patients With Braces

The aim of this study is to assess the efficacy of dental water jet in plaque removal and gingival health during orthodontic treatment with fixed appliances.

Subjects will be randomized into two groups. The first group will receive a dental water jet and the second group will receive dental floss. Plaque accumulation using plaque index and gingival health using gingival index will be measured at baseline and after four weeks for each group and then, results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Subjects having orthodontic fixed appliance.
* Subjects aged 12 years old and above who own mobile phones and no mental or physical disabilities.
* Subjects willing to comply with given oral hygiene instructions.
Orthotics and Achilles Load in Runners

Compare Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet.

This was a controlled laboratorial, within subject, repeated measures study. The aim of this study was to compare two clinically applied treatment options: Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet. It implicated to provide a better understanding of the types of foot orthoses for flatfeet runners and additional biomechanical evidence for the clinical field to guide orthotic prescription as well as selection for Achilles tendinopathy management.

Eligibility Criteria:
Inclusion:

* Foot Posture Index (FPI) was used as evaluating pronated foot posture. Subjects with FPI scores of 6-12 were recruited in the current study.
* All participants should be free of Achilles tendinopathy and triceps surae injury for 6 months.
* no previous surgery.
* not previously attempted any foot orthoses intervention before this study.

Exclusion:

* leg-length discrepancy
* rigid forefoot varus deformity
* gastrocnemius equinus
* structural hallux limitus, or rigidus
* Any musculoskeletal or neurological disorders
Video-based Consensus Opinion for Hand and Upper Extremity Problems

The investigators would like to determine if there is a difference in patient satisfaction among patients who have puzzling pain conditions and receive one evaluation from their treating physician, and those that receive an evaluation from their treating physician and from a group of consulting physicians by video. The investigators expect to enroll 128 patients at Massachusetts General Hospital.

Before visiting a specialist, patients have assumptions regarding diagnosis, etiology, prognosis, and preferred treatment for their condition. Naturally, some of these assumptions may be inaccurate or incomplete or there may be room for debate and disagreement even among specialists. We are looking for ways to make unexpected and indeterminate aspects of an illness less unsettling for patients. When the hand surgeon's advice doesn't ring true, the patient may lose confidence in that provider. Sometimes the interaction can feel disrespectful and even adversarial. We are curious whether patient's satisfaction with diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from many surgeons at once. One feasible way to do that would be to show an edited and anonymized video to a set of hand surgeons for their opinions on diagnosis and treatment.

Primary study question:

1. Among patients with initially puzzling pains, there is no difference in satisfaction with diagnosis between patients that receive a video based consensus opinion and those that receive routine care from a single hand surgeon controlling for psychological factors, demographics, and initial and final diagnosis.

   Secondary study questions:
2. Among patients with initially puzzling pains, there is no difference in pain intensity and disability one month after the initial visit between patient that receive a consensus diagnosis and those that receive routine care from a single surgeon.
3. There is no variation in diagnosis between observers (Observers are hand surgeons viewing the visit video and consulting on the diagnosis).

Eligibility Criteria:
Inclusion Criteria:

* All patients (\>18 years) presenting to Dr. David Ring with painful conditions that are puzzling (A puzzling pain condition is defined as Dr. Ring being puzzled about what is causing the pain. Subject eligibility based on this criterion will be determined by Dr. Ring).
* English fluency and literacy
* Able to provide informed consent

Exclusion Criteria:

* Pregnant Women
Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

An averaged magnetization inversion recovery acquisitions (AMIRA) sequence was proposed for SC MRI. This MR-sequence delivers excellent contrast between the SC gray and white matter as well as between the SC and cerebrospinal fluid (CSF) in clinically feasible-acquisition times. Moreover, the high quality and in-plane resolution of AMIRA images allows for segmentation of the SC gray and white matter with high accuracy and reproducibility. This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis according to established international criteria
* Steroid free period: \> 4 weeks
* Participation in the Swiss MS Cohort (SMSC) study

Exclusion Criteria:

* . History of severe (other) neurological, internal or psychiatric disease with SC affection
* MRI-related exclusion criteria (questionnaire):

  1. Paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the SC)
  2. Pacemaker
  3. Claustrophobia
  4. Pregnancy, lactation
  5. Known hypersensitivity to gadolinium-based contrast media
Evaluation of Different Continuous Positive Airway Pressure (CPAP) Systems in Patients With Acute Respiratory Failure

The aim of this study is to evaluate the performance, the tolerability and the efficacy on gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems.

Three CPAP systems are studied for each patient at the same level of PEEP: 1) continuous high-flow CPAP with fixed value PEEP valve; 2) continuous high-flow CPAP with Boussignac PEEP valve; 3) demand flow CPAP, supplied by a ventilator.

Eligibility Criteria:
Inclusion Criteria:

* Intubated-tracheostomized subjects receiving CPAP during the weaning from invasive mechanical ventilation

Exclusion Criteria:

* Hemodynamic instability
* Barotrauma
* Severe myopathy