cyrilzakka/clinical-trials huggingface dataset:
Identification of a Responsive Subpopulation to Hydroxychloroquine in COVID-19 Patients Using Machine Learning

The purpose of this study was to assess the performance of a machine learning algorithm which identifies patients for whom hydroxychloroquine treatment is associated with predicted survival.

In a multi-center pragmatic clinical trial, COVID-19 positive patients admitted to 6 United States medical centers were enrolled between March 10 and June 4, 2020. A machine learning algorithm was used to determine which patients were suitable for treatment with hydroxychloroquine.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to covered ward and tested positive for COVID-19
* Patient had COViage applied to electronic health record data within four hours of COVID-19 test

Exclusion Criteria:

* Patient not admitted to covered ward or tested negative for COVID-19
* Patient had COViage applied to electronic health record data greater than four hours after COVID-19 test
Activity Monitoring in Pulmonary Hypertension

This is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12 weeks.

A prospective, longitudinal, observational study of free-living activity tracking and patient-reported outcomes in patients with pulmonary hypertension. Participants will undergo activity monitoring for 12 weeks once a year for 4 years. Patient-reported outcomes will be collected including quality of life (emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys), medication changes, hospitalization, and death. This study aims to enroll 500 participants. The objectives of this study are to establish the clinical utility of daily activity tracking in patients with pulmonary hypertension and to identify clinical factors associated with reduced daily activity.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in L-PVDOMICS or
* Any patient in the United States with pulmonary hypertension confirmed by hemodynamics and expert clinical diagnosis

Exclusion Criteria:

* Pregnancy
* Hospitalization within the prior 3 months
* Orthopedic limitations that preclude 6MWD testing
Nerve Stimulator Versus Ultrasound-guided Interscalene Block for Shoulder Surgery

The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided interscalene block after shoulder surgery.

Ultrasound (US)-guided peripheral nerve block has increased in popularity. It has many advantages such as improved success rate, faster onset time, fewer needle passes, shorter performance time, and reduced procedural pain and vascular puncture. However, there is no information about postoperative analgesia.

Therefore, the investigators tested whether nerve stimulator (NS) - guided interscalene block was inferior to ultrasound-guided block in terms of duration of postoperative analgesia for shoulder surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class I - III patients scheduled to undergo shoulder surgery

Exclusion Criteria:

* coagulopathy, severe pulmonary disease, neuropathy, contralateral diaphragmatic paresis, allergy to study medications
The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics

The study will examine role of transvenous pacing on coronary microcirculation.

To study the role of transvenous pacing on the coronary microcirculation. This will be accomplished by gathering data from invasive Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) with and without ventricular pacing.

Eligibility Criteria:
Inclusion Criteria:

All patients 19 years of age or older with clinical evidence of coronary ischemia undergoing coronary angiogram, and who have a pacemaker.

Exclusion Criteria:

* Acute ST segment myocardial infarction
* Known sensitivity or contraindication to the agents planned for administration during coronary angiography
* Pacemaker dependent patients
* Pregnancy
* Hypotension (a systolic blood pressure lower than 90mmHg) that would preclude the administration of adenosine
* Severe renal dysfunction, defined as a estimated glomerular filtration (eGFR) less than 30ml/min, confirmed by recent testing
* Study subject has any underlying disorder that, in the opinion of the investigator, precludes them from giving informed consent at the time of enrollment
Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study)

To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus
* adults aged ≥ 20 and aged ≤ 70 years old
* Patients who had not taken anti diabetes drug for 8 weeks prior to screening visit with HbA1c ≥ 7.5%
* All patients give written informed consent
* Patients applicable to any one of following 3 categories

  1. Patients with surgically induced infertility
  2. Post-menopause woman ≥45 years of age with over 2 years from the last menstruation
  3. Fertile pre-menopause woman or male patients who has consented for use of two or more contraceptive methods at least up to 14 days after final administration of the investigational product to avoid getting pregnant

Exclusion Criteria:

* Patients with Type 1 Diabetes, Patients with Diabetic Ketoacidosis or Diabetic Coma as well as Pre-coma
* Patients with Gestational Diabetes Mellitus or with Secondary Diabetes
* Patients with NYHA Class III, IV Congestive Heart Failure or with Treatment-requiring Arrhythmia
* Patients with Thyroid Dysfunction whose TSH is out of normal range, requiring medication therapy
* Patients with pituitary insufficiency or hypoadrenalism
* Patients whose BMI is less than 20 Kg/m2 or exceeds 40 Kg/m2
* Patients whose Total Bilirubin level is 1.5 times higher than the upper limit of normal range and ALT/AST are \> 2.5 times higher than the upper limit of normal range
* Patients currently taking strong CYP3A4 inducers
* Patients currently taking Warfarin, Dicoumar or Digoxin
* Patients currently taking any medication from within 4 weeks before Visit 1 (screening) likely to have significant effects on glycemic control or who require to take such medication
* Patients who had taken anti-obesity drugs within 12 weeks in prior to Visit 1 (screening)
* Subject who had been treated with Insulin or GLP-1 analogue within 6 months before Visit 1 (screening)
* Patients who had participated in other clinical study in the past 3 months before Visit 1 (screening)
* Any other patients whom the investigator considers as inadequate for this study
Follow-up of Adult Phenylketonuria (PKU) Patients

Adult patients with phenylketonuria (PKU) at the age around 40 years belong to the first patients generation with early treatment of the disease. PKU is caused by an inborn error of the amino acid metabolism and the so far best suitable therapy is an early and strict diet, which is low in phenylalanine.

Besides an early and continuously treatment in childhood, the nutritional and medical support during adolescence and adulthood have been suggested to influence the long-term physical health of adult PKU patients. As many adult PKU patients tend to neglect the necessarily strict diet, they do not get a balanced diet. For PKU patients some nutrients, which may be rare in an unbalanced diet, might help to improve health status, physical and neurological performance and quality of life.

Information about the longitudinal development of the patients status and the influence of the type of their medical care is not available. In this 5 year follow-up the investigators aim to study the quality of life and the medical, nutritional and psychological status of adult PKU patients, in whom corresponding information has already been collected previously.


Eligibility Criteria:
Inclusion Criteria:

* assured clinical diagnose of PKU or proof of mutation in the phenylalanine hydroxylase gene (for PKU patients only)
* both groups need to hand in a signed consent to participate in the study
* controls: have to be omnivores and should not be on drugs, which influence the lipid metabolism, during the last 3 months
* attendance of the last study trial

Exclusion Criteria:

* not fulfill the inclusion criteria
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia

The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age between 18 and 70 years
* diagnosis of breast cancer patients who need to receive multi-cycle chemotherapy
* grade III/IV neutropenia after chemotherapy
* KPS score≥70
* life expectancy of at least 3 months
* Written informed consent are acquired

Exclusion Criteria:

* Have accepted any other drug related clinical trial within 4 weeks before anticipated
* uncontrolled infection
* pregnancy
* Other situations that investigators consider as contra-indication for this study
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions

To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Comparative Effect of Cylindrical Lenses Verses Spherical Equilient on Contrast Sensitivity

the concept of spherical equivalent plays a pivotal role in simplifying the prescription and enhancing communication between eye care professionals and patients. The spherical equivalent is a calculated value that condenses the spherical and cylindrical components into a single power.

Mathematically, it is determined by adding half of the cylindrical power to the spherical power (SE = Sphere + (Cylinder/2)). This calculated value serves as a convenient representation of the overall refractive error, aiding in a more straightforward understanding of the prescription. Understanding their individual and collective impact on contrast sensitivity opens up new avenues for refining corrective interventions and enhancing the overall quality of vision. This article aims to demystify the intricate relationship between spherical equivalent and cylindrical correction, and their collective impact on contrast sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Patients within 18 to 35 years will be included.
* Both genders will be included.
* Patients having astigmatism will be included.
* Patients having 6/6 corrected vision will be included.
* Eyes having no other ocular pathology will be included.
* Patients having no history of ocular surgery or corneal scar will be included.

Exclusion Criteria:

* i. Eyes having any ocular pathology will be excluded.
* Patients with corneal suture will be excluded.
* Those using contact lenses instead of spectacles for vision correction will be excluded.
* Participants with a history of eye surgery within the past year will be excluded.
Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection

This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii on HIV-1 reservoir.

Two arms will be enrolled in this study, 18 naive-treatment Chinese patients in acute HIV-1 infection phase would be allocated to two arms, and treated with the antiretroviral drugs (Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir). Six months later, 12 patients will be treated with Triplitode, in order to observe the impact of of Triptolide wilfordii on HIV-1 reservoir of patients in acute infection phase. All patients should be explored for 18 months in terms of the clinical features, drugs side-effects, and immunological and viral response, and the HIV-1 reservoir. We hypothesis that Triptolide wilfordii might further reduce the HIV-1 reservoir. The result would provide proofs for further practical antiviral therapy for patients in acute infection phase in China or other resource limited countries.

Eligibility Criteria:
Inclusion Criteria:

* • age between 18-65 years

  * HIV seropositive and confirmed by western blot, confirmed as acute HIV-1 infection
  * good adherence and follow up in the same place
  * Inform Consent signed
  * ART-naïve

Exclusion Criteria:

* Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;

  * hemoglobin (HGB) \< 9 g/dl 、 white blood cell (WBC) \< 2000/ul 、 granulin (GRN) \< 1000 /ul 、 platelet (PLT) \< 75000 /ul 、 Cr \>1.5x ULN 、 ALT or AST or alkaline phosphatase (ALP) \>3x upper limit of normal (ULN) 、 total bilirubin (TBIL) \>2x ULN 、 creatine kinase (CK) \> 2x ULN;
  * Pregnant or breastfeeding woman or woman with pregnancy plan;
  * Active drug-user;Severe neurological defects;
  * Active alcohol abuse;
  * Severe gastrointestinal ulcer .
  * End-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc
  * Those who are undertaking steroids, immunomodulator, anti-inflammatory agents
Postural Correction Exercises Effect on Forward Head Posture

To determine the effect of postural correction exercise in universities students regarding cervical sagittal posture, head flexion angle in forward head posture.

Informed consent will be taken from the participants, then we move further toward their demographics which will lead to initial readings after completion of authenticated questionnaire, then application of performing technique/exercise protocol by therapist and note the measurements again then interpret and analyze the data through data analyzing software which will lead to conclude the process.

Eligibility Criteria:
Inclusion Criteria:

* University students of age between 18 to 30 years.
* Smart devices addictions for one or more than one year and 2 h per day.
* CVA of less than 54°.
* Smartphone Addicted scale - short version SAS-SV

Exclusion Criteria:

* History of neurological symptoms and surgery to the neck and/or upper limbs.
* Smart devices usage less than one year.
* Unable to perform the exercises
Comparison of Preoperative Frailty Assessment Tools

Frailty is a significant risk factor for postoperative complications and functional decline. Preoperative assessment of frailty is therefore recommended in all older adults. However, despite the availability of many frailty tools, few have been tested in the preoperative setting and there is little comparison of their predictive value in identifying patients at risk. The aim of this study is to investigate which of the following instruments for determining frailty has the highest predictive power with regard to the occurrence of postoperative complications: Risk Analysis Index, Clinical Frailty Scale, the Groningen Frailty Indicator, the Edmonton Frail Scale and the LUCAS-FI. The aim of this research project is to identify a suitable frailty instrument for preoperative risk stratification of older patients during the premedication visit.


Eligibility Criteria:
Inclusion Criteria:

* 70 years and older
* scheduled surgery
* estimated time of surgery 120 Minutes or more

Exclusion Criteria:

* insufficient German language skills (for cognitive testing)
* mental retardation
* relevant psychiatric disorder (not allowing for cognitive testing)
To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions

To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Soft Coagulation for the Prevention of Adenoma Recurrence

Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) \>= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.


Eligibility Criteria:
Inclusion Criteria:

* Referred for removal of a colonic polyp \>= 20mm in size
* Able to give informed consent to involvement in trial

Exclusion Criteria:

* Younger than 18 years of age
* Highly dependant on medical care
* Women who are pregnant or may be pregnant.
* Taken clopidogrel within 7 days
* Taken warfarin within 5 days
* Had full therapeutic dose unfractionated heparin within 6 hours
* Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
* Known clotting disorder
* Previous attempt at EMR of the polyp referred for resection
* Polyp located at the ileo-caecal valve, appendiceal orifice
* Fully circumferential polyp
* Incomplete snare resection of the polyp
Effects of Aromatase Inhibitor Therapy on Muscle Function

This is a pilot study designed to examine changes in muscle function after Aromatase Inhibitor (AI) therapy, at both the molecular and clinical level.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Post-menopausal
3. Diagnosis of ductal carcinoma in situ (DCIS) or stage I, II, or III ER positive breast cancer
4. Plan to initiate an AI per treating physician.
5. Completion of all primary therapy for breast cancer, including surgery, radiation, and chemotherapy (should be completed 14 days or more prior to obtaining the baseline muscle biopsy). Ongoing HER2 targeted therapy with trastuzumab and/or pertuzumab is allowed. Ongoing neratinib therapy is not allowed.
6. Body weight less than 350 lbs., as dictated by the weight limit for DXA (dual energy x-ray absorptiometry) scanner
7. Must be willing to undergo muscle biopsy at baseline and after 24 weeks of AI therapy
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of study enrollment
9. Informed consent and authorization of the release of health information must be obtained according to institutional guidelines

Exclusion Criteria:

1. Unwilling to co-enroll into the FIT core study
2. Diagnosis of severe osteopenia or osteoporosis, defined as a bone mineral density of ≥ 2.0 standard deviations below the young adult female reference mean (T score)
3. Diagnosis of other disorder affecting bone function or turnover, such as Paget's disease, renal osteodystrophy, parathyroid disorders, or vitamin D deficiency/osteomalacia
4. Prior history of non-traumatic, fragility bone fracture
5. Any muscle or neuromuscular disorder affecting muscle function, such as muscular dystrophy, myositis, or amyotrophic lateral sclerosis
6. Any condition precluding power protocol participation (i.e. exertion on a stationary bicycle), including: New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled angina, myocardial infarction in the prior 12 months, orthopedic surgery in the previous 6 months or plans for orthopedic surgery during the study period, chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms \> 2 days/week) or dyspnea requiring oxygen, symptomatic peripheral vascular disease, or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator
7. Need for daily anticoagulation use
8. Allergy to local anesthetic
9. Locally recurrent or metastatic breast cancer a. History of prior treated malignancies, other than breast cancer, that are now stable, are in remission, and do not require active therapy, are acceptable.
Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer

CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.

This is a randomized phase II study, open-label and multicentric. After initial intervention (debulking surgery or diagnostic surgery) patient will randomized in the study according to Completeness of cytoreduction (CC) score (CC0 or CC\>1).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced (FIGO stage III or IV) invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer. Pleural cytology has to be performed in patients with pleural effusion.
* Initial intervention : debulking surgery or diagnostic surgery in the 3 weeks before inclusion
* Age ≥18 and \< 75 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 before surgery (ECOG ≤ 1 and Lee score \< 6 in patients \> 70 years old).
* Adequate blood count (test realized in the past 14 days before inclusion) : neutrophils \> 1500/mm3, platelets \> 150 000/mm3.
* Creatinine clearance MDRD ≥ 60 mL/min
* Registration in a national health care system (CMU included).
* Signed and dated informed consent.

Exclusion Criteria:

* FIGO stage IV extra-abdominal disease, with the exception of lymph nodes and pleural invasion.
* Patient having received previous chemotherapy for ovarian cancer.
* Left ventricular ejection fraction \< 50% before chemotherapy initiation
* Other invasive cancer in the past 5 years (baso- and spinocellular cutaneous carcinoma with complete resection are accepted)
* Concomitant administration of prophylactic phenytoin or live attenuated viral vaccines such as yellow fever vaccine,
* Patients with known hypersensitivity to any component of study drug
* Patients without motivation or capacity to respect study requirements and constraints
* Pregnancy or breast feeding women
Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy

The purpose of this study was to compare the clinical outcomes of teeth deep cleaning or scaling and root planing (SRP) using a periodontal endoscope (Perioscopy®) versus traditional SRP using magnifying loupes for up to twelve months, utilizing a split mouth design.

Twenty-five (25) patients were recruited for the study that exhibited mild to moderate periodontitis. SRP or deep cleaning was rendered by the same experienced hygienist, following random assignment of the left or right half of the mouth to either recieve deep cleaning by using a periodontal endoscope (Perioscopy®) or traditional deep cleaning using magnifying loupes. All the periodontal evaluations were done by the same periodontal resident at baseline, one month, three months, six months, and twelve months after deep cleaning.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* in good general health
* given a diagnosis of mild-moderate generalized chronic periodontitis per the 1999 world workshop classification of periodontal diseases and conditions
* required whole mouth SRP
* teeth had a maximum of 6mm probing pocket depth at any site
* at least one molar present in each arch, excluding third molars.

Exclusion Criteria:

* any requirement for antibiotic premedication prior to dental treatment
* uncontrolled hypertension
* uncontrolled diabetes
* subject unwilling to sign the informed consent
* subject needed any antibiotic intervention for unrelated conditions