cyrilzakka/clinical-trials huggingface dataset:
Cartilage Biomarkers and HEAD-US Score in Severe Hemophilia A Patients Receiving FVIII Prophylaxis

Patients with severe hemophilia A often develop joint complication requiring careful monitoring. This study aimed to compare the effectiveness of standard low dose weight-based FVIII concentrates (CFCs) prophylaxis with pharmacokinetic-guided extended half-life FVIII concentrates (eHLFVIII) using cartilage biomarkers and HEAD-US score.


Eligibility Criteria:
Inclusion Criteria:

* patients with severe hemophilia A
* previously receiving standard low dose FVIII prophylaxis 1-3 times per week for at least 6 months prior to enrollment in the project
* no history of FVIII inhibitor (\<0.6 Bethesda unit/ml)
* obtained consent from both patients and their parents

Exclusion Criteria:

* patients with underlying condition affecting the joints such as osteoarthritis, metabolic bone disease, etc.
3D Kinematic Assessment of the Human Knee During Physical and Daily Life Activities

Problem : Precise and personalized 3D knee kinematic assessment during physical and daily life activities is a challenge; therefore, it was never performed on an important number of individuals. However, a better understanding of 3D knee kinematics during such activities would allow a better understanding of this often injured joint.

Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation device that can be used under local anesthesiaallows for precise and reproducible assessment of 3D knee kinematics during physical and daily life activities.

Objectives :

* To study human knee 3D kinematics during dynamic activities using a novel minimally invasive measuring system
* Investigate the correlations between standard clinical knee laxity tests and measured 3D knee kinematics during dynamic activities


Eligibility Criteria:
Inclusion Criteria:

* Patients awaiting knee arthroscopy under local anesthesia for a medial meniscal tear

Exclusion Criteria:

* Active infection
* Severe swelling of the knee
* Knee flexion contracture
* Knee flexion less than 120 degrees
* Gross limping
* Inability to perform the various motor tasks required by the study protocol
YF476 and Type II Gastric Carcinoids

This study will evaluate whether treatment with YF476 is safe and effective in reducing the size of type II gastric carcinoid tumours, or limiting the abnormal growth of gastric ECL cells, in patients with Zollinger-Ellison syndrome.


Eligibility Criteria:
Inclusion criteria:

1. Men; post-menopausal women; pre-menopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophorectomy; or pre-menopausal women using one of the allowed methods of contraception: condom and spermicide or intra-uterine device.
2. Patients with serum gastrin \>250 pg/mL.
3. Hepatic function: AST and ALT ≤2.0 x ULN; total bilirubin ≤1.0 x ULN.
4. Renal function: serum creatinine \<1.0 x ULN.
5. Haematologic function: Hb ≥10.0 g/dL; WBC ≥3.5 x 10e9 /L; ANC ≥1.5 x 10e9 /L; platelets ≥100 x 10e9 /L.
6. Coagulation parameters: INR or PT ≤1.0 x ULN; PTT ≤1.0 x ULN.
7. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
8. Willingness to give fully-informed, written consent.

Exclusion criteria:

1. Patients under 18 years.
2. Women who are pregnant, lactating or using a steroid contraceptive.
3. Prior gastric resection or bypass.
4. Planned gastrinoma resection during the study period.
5. Patients on somatostatin analogues, except for those on therapy for \>6 months with stable or worsening carcinoids.
6. Inability to tolerate endoscopy, or refusal of endoscopy.
7. Physical findings, ECG (especially prolonged QTc interval \>450 msec), or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the subject.
8. Certain medicines and herbal remedies taken during the 7 days before visit 2.
9. Participation in a trial of an IMP within the previous 28 days.
10. Presence of drug or alcohol abuse.
11. History or baseline findings of:

    * type 1 diabetes mellitus;
    * pancreatitis (baseline amylase and/or \>2.0 x ULN);
    * hepatitis B, hepatitis C or HIV;
    * malabsorption syndrome or inability to swallow or retain oral medicine;
    * major surgery \<28 days prior to enrolment;
    * ECOG performance status \>2; or
    * another cancer within 3 years except for basal carcinoma of the skin or cervical carcinoma in-situ.
    * Also, any clinically significant and uncontrolled major morbidity including but not limited to; serious cardiac disease (unstable angina, s/p myocardial infarction \<1 month); respiratory disease (advanced COPD or pulmonary fibrosis); uncontrolled hypertension; or active systemic infection.
Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks

The primary objective is to assess if the utilization of a decision-aid increases the likelihood of low-risk nulliparous women undergoing elective induction of labor at 39.0-39.6 weeks


Eligibility Criteria:
Inclusion Criteria:

* Low-risk nulliparous women- no previous pregnancy \> 23 weeks
* 18-50 years of age
* Singleton gestation
* Between 34.0 and 36.6 weeks at the time of screening. Randomization must occur between 37.0-37.6 weeks inclusive.

Exclusion Criteria:

* 1. First sonographic examination after 20 weeks 2. Women with any of the following comorbidities (at the time of randomization):

  1. Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma)
  2. Cerclage in the index pregnancy
  3. Diabetes mellitus-gestational or pre-gestational
  4. Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia)
  5. Hypertension (chronic or pregnancy induced) before enrollment
  6. HIV (human immunodeficiency virus)
  7. Institutionalized individuals (prisoners)
  8. Prior obstetric history of: 1) intrauterine growth restriction, 2) preterm birth before 34 weeks, 3) severe preeclampsia, eclampsia, HELLP syndrome, and 4) stillbirth after 24 weeks or neonatal death
  9. Preterm labor or ruptured membranes before enrollment
  10. Psychiatric disorder (bipolar, depression) on medication
  11. Placenta previa / 3rd trimester bleeding
  12. Renal insufficiency (serum creatinine \> 1.5 mg/dL)
  13. Restrictive lung disease
  14. Fetal red blood cell isoimmunization
  15. Seizure disorder on medication
  16. Thyroid disease on medication
  17. Body Mass Index (BMI) above 40 kg/m 3. Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects 4. Unable to understand consent in English or Spanish
Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies

Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.

At the time of enrollment in the Registry, participant records will be queried for retrospective information about the participant's medical history and AQP4+ NMOSD treatment history for the time period beginning 1 year prior to ALXN-C5IT initiation through Registry enrollment. The duration of data collection for the Registry will be approximately 5 years from the day the last participant is enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Participant is ≥ 18 years of age at the time of enrollment in the Registry.
* Participant must have a confirmed diagnosis of AQP4+ NMOSD.
* At the time of enrollment in the Registry, participants must be receiving treatment with ALXN-C5IT for the purpose of chronic relapse prevention in a manner consistent with the local label. Specifically, they should have received at least 1 dose of eculizumab within 4 weeks prior to enrollment or at least 1 dose of ravulizumab within 12 weeks prior to enrollment.
* Participants must have both the following historical data available to be enrolled in the Registry: ALXN-C5IT dosing information since initiation and number and types of relapses from 1 year prior to ALXN-C5IT initiation through Registry enrollment.

Exclusion Criteria:

* Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.
Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)

The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.


Eligibility Criteria:
Inclusion Criteria:

* A subject must be 6 to \<18 years of age, of either sex, and of any race.
* A subject must have a diagnosis of bilateral nasal polyps.
* A subject must have a minimum nasal congestion/obstruction
* An asthmatic subject may be included.
* A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor.
* The subject and parent/guardian must be willing to give written informed consent, and the subject must be able to adhere to dose and visit schedules.
* A female subject of child-bearing potential who is sexually active must have been using a medically accepted method of contraception prior to Screening and must continue using it while receiving protocol-specified medication. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit

Exclusion Criteria:

* A subject with antrochoanal polyps.
* A subject with cystic fibrosis.
* A subject with acute sinusitis, concurrent upper respiratory tract infection, or who had an upper respiratory tract infection within 2 weeks prior to the Screening Visit.
* A subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
* A subject who is immunocompromised.
* A subject with ongoing rhinitis medicamentosa.
* A subject with Churg Strauss syndrome.
* A subject with dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immotile cilia).
* A subject with any clinically significant pretreatment laboratory, vital sign, or ECG abnormality.
* A subject with allergy/sensitivity to aspirin, corticosteroids, or study drug or its excipients.
* A subject who has not observed the medication washout times outlined in the protocol prior to the Screening Visit.
* A female subject who is breast-feeding, pregnant, or intends to become pregnant.
* A subject who has used any investigational drug within 30 days of Screening.
* A subject who is part of the staff personnel directly involved with this study.
TNF Alpha in Refractory Asthma

The purpose of this study was to investigate whether the administration of etanercept to patients with severe asthma improved their asthma related quality of life and a measure of the degree of reactivity of the airways

Although steroid dependent asthma represents a small population of patients with asthma, they consume a disproportionately large amount of the health resource burden attributed to asthma. Treatment options in this group are extremely limited; the development of effective treatments for this group of patients should be a priority, not only for increasing individual patient quality of life but for long term reduction of health spending.

This randomised, double blind, placebo controlled, cross over trial will investigate the efficacy of a soluble TNF receptor, etanercept, in severe, steroid dependant asthma.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic asthma Methacholine PC20\<8mg/ml

Exclusion Criteria:

* History of poor treatment concordance History of tuberculosis Radiographic evidence of previous tuberculosis Recent tuberculosis contact Respiratory tract infection within 3 months Current Smoker or Ex-smoker with more than 5 pack years Symptomatic co-morbid condition Contra-indication to etanercept Pregancy Breast feeding
Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg

Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years of age or older
* Hypertension defined by MSDBP \> 90 and or MSSBP \> 140 mmHg, MSDBP \> 80 mmHg, or/and MSSBP \> 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
* Written informed consent to participate in the study prior to any study procedures

Exclusion Criteria:

* Severe hypertension (grade 3 WHO classification MSDBP \> 110 mmHg and/or MSSBP \> 180 mmHg)
* Evidence of a secondary form of hypertension
* Type 1 diabetes mellitus
* History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.


Eligibility Criteria:
Inclusion Criteria:

* Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit
* Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential

Exclusion Criteria:

* Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
* Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
* Increased risk of infection
* Pregnancy or lactation
Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4

A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of MRX-4 given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable intravenous dose of MRX-4 to determine bioavailability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder
Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)

The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and up to 12 weeks Run-in Phase (all subjects will have patiromer initiated and RAASi medications, including mineralocorticoid receptor antagonist (MRA) optimized) and a randomized withdrawal Blinded Treatment Phase.

The study population includes subjects with heart failure (HF) with reduced ejection fraction (HFrEF) who are hyperkalemic (serum potassium \[K+\] \> 5.0 mEq/L) while receiving treatment with renin angiotensin aldosterone system inhibitor (RAASi) medications or who are normokalemic (serum K+ 4.0 - 5.0 mEq/L) but have a history of hyperkalemia prior to screening with subsequent reduction or discontinuation of a RAASi medication.

Each subject's participation includes a Run-in Phase (maximum 12 weeks) followed by the Treatment Phase (variable per subject). Study duration for individual subjects will vary, depending on their individual enrollment date. Subjects who prematurely discontinue patiromer/placebo will remain in the study for the collection of clinical events data and will receive usual care.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years or greater
* Symptomatic low ejection fraction heart failure (weak heart muscle)
* Receiving any dose of a beta blocker for the treatment of HF (unless not able to tolerate)
* Kidney function not more than mild or moderately impaired
* High blood potassium (\>5.0 mEq/L) currently while receiving medications for heart failure OR normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications
* Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening.

Exclusion Criteria:

* Current acute decompensated HF, within 4 weeks before screening. Subjects with a discharge from a hospitalization for acute decompensation of HF longer than 4 weeks before screening may be included
* Significant primary aortic or mitral valvular heart disease (except secondary mitral regurgitation due to left ventricular dilatation)
* Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting list) during the study period
Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer

In this trial, the effect of intrapleural docetaxel administration using medical pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.

This study is designed to be pilot, single-center, open-label, single-arm, prospective, phase II trial of patient with NSCLC with pleurla effusion. Approximately 40 patients will be enrolled into the trial, and study will be performed to 31Dec2018 from IRB and Korea: MFDS approval date.

Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. Response evaluation will be done until confiramtion of disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20, and NSCLC patients with malignant pleural effusion and related symptoms
* ECOG ≤ 2
* Blood test ANC≥ 1500/mm3, Hb ≥ 8.0g/dl, platelet count ≥ 100000/mm3 Serum creatinine ≤ 1.8mg/dl, Total bilirubin within normal limits, Transaminases ≤ 1.5 x UNL, Alkaline phosphatase ≤ 2.5 X UNL BUN ≤ 25mg/dl, Creatinine clearance ≥ 50ml/min
* Negative serum or urine pregnancy test for women for childbearing age
* Patients who provide written informed consent for the study

Exclusion Criteria:

* Age \< 20
* Patients who were previously perfomed pleurodesis
* Patients who were previously treated with thoracic radiosurgery
* Patinet with bilateral pleural effusion
* Age ≥ 80yrs
* Patients with histories of hypersensitivity to Docetaxel
* Patients with cardiovascular, respiratory, hepatic, renal, gastrointestinal, neunological disease, asthma, MI, stroke, arrhythmia, uncontrolled hypertionsion, etc. that would effect absorption, distribution, and metabolism of IP or be risk factors during IP administrion.
* Patients who could not understand the study procedure
Feasibility Study of a Systematic Approach for Deprescribing of Statins and PPI's.

Deprescribing, the process of safely reducing or discontinuing unnecessary or harmful medication, has the potential to decrease polypharmacy and improve health outcomes. In this study a structured implicit algorithm, focusing on both extrinsic medication factors (eg change in disease) and intrinsic patient factors (eg. pill burden) will be used.


Eligibility Criteria:
Inclusion Criteria:

* Participant uses a statin and/or a proton pump inhibitor.
* Participant signs informed consent.
* Participant is a nursing home resident.

Exclusion Criteria:

* Participant is there for short term nursing home admission (\<3 months)
* Participant is there for hospice admission.
Product Preference With Systane Compared to Artificial Tears on Frequency of Drop Use

The objective of this study was to evaluate the effect of Systane® compared to marketed artificial tears on the frequency of drop use.


Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 (minimum); reported history of dry eye syndrome in both eyes; TFBUT ≤ 7 seconds in at least 1 eye at Visit 1; ≥ 1+ fluorescein staining score in any region in at least 1 eye at Visit 1; desire to use an artificial tear substitute for dry eye symptoms at least 4 times per day at Visit 1 and Visit 2.

Exclusion Criteria:

* Age less than 18 years
Melatonin Levels on COVID-19 Positive Pregnant Women

This study aimed to investigate the prognostic value of serum melatonin as a biomarker for the determination of severe COVID-19 infection in pregnant women.

Four study groups were formed, including pregnant women with a positive COVID-19 PCR test, severe symptoms, and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints, but had a PCR test due to the surveillance program and negative test results were included in the control group.

Methods and Main Outcome measure: Laboratory values of the cases at the time of diagnosis parameters were collected.

Melatonin levels decrease in pregnant women with COVID-19 symptoms, the severity of symptoms increases. In addition, patients with low melatonin levels have an increase in infection parameters and an increase in the hospital stay.

A total of 228 pregnant women included in this prospective controlled study between June 20021 and June 2022 at Gynecology and Obstetrics Department of Health Sciences University Samsun Training and Research Hospital.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with a positive COVID-19 PCR test and severe symptoms and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints but had a PCR test due to the surveillance program and negative test results were included in the control group. Pregnant women who had contact with people with COVID-19 infection and had a PCR test due to the surveillance program and had positive results, but no complaints were included in the other study group. The PCR test of pregnant women who had complaints and needed inpatient treatment during the COVID-19 infection was confirmed, and the COVID-19 infection was graded according to WHO's criteria. Pregnant women with viral infection with symptoms compatible with infection and virus isolation in any culture samples collected at admission were included in the patient group with PCR positive mild-moderate and severe COVID-19 infection.