cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF

The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumer devices
* Age 18-80 years
* Willing and capable of providing written consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria:

* Previous surgical or catheter ablation for AF
* Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
* Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field
* Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
* Life expectancy less than 12 months
* Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial
Spectral CT Clinical Trial

The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.

Under the premise of protecting subjects and ensuring the scientific nature of this clinical trial, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers (ages 18 to 75);
* Negative pregnancy tests for women of childbearing age;
* Agree to participate in the clinical trial and sign the subject informed consent form;
* Enhanced scan requires laboratory evidence of normal renal function.

Exclusion Criteria:

* The body cannot comply with CT examination;
* Pregnant and lactating women;
* Claustrophobia;
* People who are not suitable for enhanced scanning with iodine contrast agent (previous severe heart failure and hyperthyroidism, iodine contrast agent allergy and susceptibility);
* Patients deemed unsuitable for participation in this clinical trial by the investigator.
Communication About Sexual Health in Gynecologic Cancer

The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns.

The main questions it aims to answer are:

1. Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone?
2. Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone?

Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone.

Participants will:

1. Fill out a consent form and survey
2. Have their next clinic visit audio recorded
3. Fill out another survey right after their clinic visit
4. Fill out a final survey 6 months after their clinic visit


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Diagnosed with any stage (I-IV) gynecologic cancer
* Receiving treatment for gynecologic cancer or completed active treatment less than 10 years ago
* Attending visits in follow-up care at Fox Chase Cancer Center
* Score of at least 3 on a sexual concerns screener question

Exclusion Criteria:

* Not able to speak English
* Not willing to have clinic visit audio recorded
* Eastern Cooperative Oncology Group (ECOG) score \> 2
* Overt cognitive dysfunction or psychiatric disturbance
Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent

self-expandable metal stents for palliation of malignant biliary strictures

The ComVi biliary stent (Taewoong Medical Inc., Seoul, Korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-PTFE) membrane sandwiched between two wire layers and has a weaker axial force than other stents.

Patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant stenosis at the middle or lower third of the common bile duct inoperable and/or unresectable.
* Patients without liver metastases and 6 months life expectancy
* Patients at the first attempt of endoscopic biliary drainage.
* Negative history for biliary tract surgery.

Exclusion Criteria:

* Patients with ampullary cancer.
* Patients with hilar and/or intra-hepatic ducts malignancy.
* Patients with haemobilia.
* Patients with acute cholangitis at the time of stenting.
* Patients with previous percutaneous, endoscopic or surgical biliary drainage.
A Long-term Observational Study Evaluating Eteplirsen, Golodirsen, or Casimersen in Routine Clinical Practice

This is a phase 4, multicenter, prospective, observational study designed to collect both medical history data and prospective data on Duchenne Muscular Dystrophy (DMD) treatment outcomes in participants receiving eteplirsen, golodirsen, and casimersen in routine clinical practice. Participants in this study will have been prescribed eteplirsen, golodirsen, or casimersen commercially prior to entry into the study.


Eligibility Criteria:
Key Inclusion Criteria:

* Is willing to provide informed assent or consent (if applicable) and has a parent(s) or legal guardian(s) or is a participant ≥18 years of age who is (are) willing to provide informed consent for the participant to participate in the study and comply with study data collection procedures.
* Has an established clinical diagnosis of DMD, as documented prior to screening by a genetic report.
* Receiving, or initiating treatment with, eteplirsen, golodirsen, or casimersen at the time of observational study enrollment. Note: Participants with a prescription for eteplirsen, golodirsen, or casimersen at enrollment must initiate the exon-skipping therapy within 6 months of the date of enrollment or will no longer be eligible for this study. Note: Enrollment of eteplirsen participants has been completed, no additional participants will be enrolled.

Key Exclusion Criteria:

* Is currently participating in any DMD interventional study at the time of this study enrollment.
* Has declined to provide consent for collection of their genetic data.
* Has a medical condition or confounding circumstances that, in the opinion of the Investigator, might compromise:

  1. The participant's ability to comply with the protocol-required procedures
  2. The participant's wellbeing or safety, and/or
  3. The clinical interpretability of the data collected from the participant.

Other inclusion/exclusion criteria may apply.
The Economic Burden of Chronic Obstructive Pulmonary Disease(COPD) in South Korea

The purpose of this study is to estimate a direct/indirect medical cost and to provide evidence establishing efficient strategies to reduce medical costs of COPD in Korea.

This study is a multi-center research on economic burdens of COPD for a year. It is composed of three phases detailed as follow.

Phase 1: Direct Cost Estimation in COPD patients (N = 400) Direct cost determined as amount of money expended to medical institutes for treatment. Estimated costs, based on the information from Health insurance review agency(HIRA) and The National Health and Nutrition Examination Survey (NHANES) data, are collected.

Phase 2: Indirect cost Estimation by Sampling Survey in COPD patient Indirect cost is extra-expanses excluding hospital fees, including cost for transportation, medical instruments, home care services and loss of labor capacity reduction. The information was collected by structured questionnaire for 12 weeks.

Phase 3: Direct/Indirect cost is validated and analyzed based on the collected information from phase 1 and 2 according to severity defined by the GOLD guideline.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old
* COPD patients

Exclusion Criteria:

* Patients who disagree with participating in research
Strategies to Improve Iodine Status in Early Pregnancy

This study aims to investigate the benefit of increased intake of cows' milk during pregnancy on iodine status.

Women of child bearing age, and those who are currently pregnant, have been found to be iodine deficient in the United Kingdom (UK). Dairy products are an essential source of iodine in the UK as iodised salt is not widely available. This study will ask women in the intervention group to drink approximately one pint of milk a day for 12 weeks during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* women at 6-16 weeks pregnant
* women receiving antenatal care within Belfast Health and Social Care Trust

Exclusion Criteria:

* women with known thyroid disease currently taking thyroid medication
* women with type one diabetes
* women under 18 years of age
* those unable to provide informed consent
* women with abnormal thyroid function tests at booking appointment.
Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap

A combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. Reconstruction of these combined injuries is difficult. When the neurocutaneous defect is associated with wound infection, reconstructive alternatives are more limited. From July 2008 to May 2010, a retrospective study was conducted with 9 consecutive postinfection patients who had the neurocutaneous defect of the finger following trauma. The purpose of this retrospective study is to report repair of the complicated infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of this technique.

sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.

Eligibility Criteria:
Inclusion Criteria:

* an infective wound with exposed bone or tendon in the finger;
* soft tissue defect involving proximal half of the middle phalanx, the proximal phalanx, or both;
* associated digital nerve defect 1 to 4 cm in length;
* single or double nerve defects; and
* simultaneous repair of nerve and soft tissue defects.

Exclusion Criteria:

* injury to the course of the pedicle or the donor site;
* nerve defect less than 1 cm or larger than 4 cm in length;
* occurrence of the defect in a region the flap is unable to reach, such as distal interphalangeal joint region, distal portion of the middle phalanx of the middle finger and the thumb;
* no involvement of the digital nerve.
Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al.

As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy within 2 months prior to the date informed consent is obtained.
* 2. Patients who INCAT score between 2-9. (If the INCAT score is 1 in upper limb, the INCAT score of 2 must be exclusively from leg disability to qualify.)
* 3. Patients who need high-dose intravenous immunoglobulin therapy.
* 4. Patients who continued treatment for CIDP without addition or increase at 30 days before informed consent.
* 5. Patients with greater than or equal to twenty years old at informed consent.

Exclusion Criteria:

* 1. Patients with evidence of myelopathy or demyelination of central nerve
* 2. Patients with evidence of stroke, central nerve system trauma, or persistent neurological deficits due to peripheral neuropathy from other causes（diabetic neuropathy, IgM paraproteinaemia, uraemic neuropathy, toxic neuropathy, hereditary neuropathy）
* 3. Patients with evidence of neuropathy or alcoholic neuropathy or vitamin deficiency neuropathy due to myeloma, lymphoma, sarcoidosis, systemic lupus erythematosus, malignancy, vasculitis, Crow-Fukase syndrome, Sjögren syndrome.
* 4. Patients with multifocal motor neuropathy.
* 5. Patients treated with plasmapheresis at 3 months before informed consent.
* 6. Patients treated with rituximab at 6 months before informed consent.
* 7. Patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent.
* 8. Patients treated with intravenous immunoglobulin at 3 weeks before informed consent.
* 9. Patients with history of shock or hypersensitivity for NPB-01.
* 10. Patients with IgA deficiency.
* 11. Patients with malignancy at informed consent.
* 12. Patients with impaired liver function.
* 13. Patients with impaired renal function.
* 14. Patients with cerebro- or cardiovascular disorders.
* 15. Patients with high risk of thromboembolism.
* 16. Patients with hemolytic/hemorrhagic anemia.
* 17. Patients with decreased cardiac function.
* 18. Patients with decreased platelet.
Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy

Hypothesis:

The angiotensin receptor blocker telmisartan is effective at reduction of albumin excretion rate(AER) in patients with type1 diabetes and micro or macroalbuminuria. Dual blockade with the addition of ramipril an angiotensin receptor blocker gives added efficacy for reduction of AER. ARB telmisartan gives a 24 hr BP lowering effect.

Summary:

This is an open label cross over study involving 30 patients who were initially treated with Telmisartan 80 mg for eight weeks followed by addition of Ramipril 10 mg for a further eight weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were studied at the end of each phase.

To evaluate the antialbuminuric efficacy of an angiotensin receptor blocker (ARB) telmisartan and the combination of telmisartan and ramipril in patients with type1 DM and either micro or macroalbuminuria.To evaluate the same drugs for their antihypertensive efficacy and their influence on dipping patterns using ambulatory BP monitoring.

Methods:

Open label cross over study involving 30 patients who were initially treated with telmisartan 80 mg for eight weeks followed by addition of ramipril 10 mg for a further eight weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were studied at the end of each phase Overnight urine samples of nine hours duration were collected . The volume of urine was verified by measurement in a jar with accuracy of 50ml by the study investigator on every occasion. . Albuminuria was estimated by immuno-turbidimetry Hemocue albumin system Angelholm AD, Sweden (inter assay CV 4.3% ). The albumin excretion rate(AER) at baseline evaluation was determined as the mean AER of the positive urine samples. During subsequent evaluations at the end of 8weeks and at the end of 16 weeks the mean albumin excretion rate from two successive overnight urine samples was taken as the mean .Ambulatory BP (ABP) measurement :ABP was measured using Spacelabs device 90207 Spacelabs inc. use of which is described before(14) .A uniform protocol of inflation once in every 30 min was used. Cuff was applied to the nondominant arm. Recordings were started in all patients between seven and ten AM.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus by ADA criteria
* Clinical history of DKA
* HbA1C \< 7.5,urine AER \>/= 20 mcg/min on two overnight urine samples

Exclusion Criteria:

* Pregnancy
* Unwillingness to use contraception during time of study
* Creatinine \>3 mg/dl
* Suspected/proven non diabetic nephropathy
* Active urinary sediment
CORONA in the Saarland

The CORSAAR study is an observational, prospective study to investigate the natural biology of COVID-19

Patients with all forms of COVID-19 are included and followed up. Medical history, measurements and biomarkers are registered and collected at baseline, dung hospitalization and after discharge. In addition, patients with LONG-COVID-19 are recruited.

Eligibility Criteria:
Inclusion Criteria:

all form of COVID-19 including long-COVID-19

Exclusion Criteria:

-
Evaluation of Swallowing Impairment After Tonsillectomy

the investigator will evaluate the swallowing pattern of the patients pre-operative and will follow them up at day 15 after tonsillectomy by using Careful history taking and Fiberoptic endoscopic evaluation of swallowing (FEES).

All patients will be evaluated pre-operative by history taking using the Arabic version of Eating Assessment Tool (EAT-10) questionnaire and will be examined by Fiberoptic endoscopic evaluation of swallowing (FEES). All patients will be operated by the same surgical technique. Patients will be directed to return back on the 15th day post-operative after tonsillectomy and they will be subjected to history taking using the Arabic version of Eating Assessment Tool (EAT-10) questionnaire and they will be examined by Fiberoptic endoscopic evaluation of swallowing (FEES).

1. Careful history taking The history of the patients will be taken using the Arabic version of the Eating Assessment Tool (EAT-10) questionnaire. The patient will rate the problem on a scale of 0 to 4 (0 means no problem; 4 means severe problem). A score of 3 or more on the EAT-10 is considered dysphagia.
2. Fiberoptic endoscopic evaluation of swallowing (FEES). Using flexible endoscopy (the flexible nasopharyngeal video-fiberscope Henke-Sass-Wolf, 4.3mm in diameter connected to Lemke video camera). The patient will be given a colored thin fluid to keep in their mouth and then swallow following the instructions of the examiner, then the examination will be repeated using semisolids (1 teaspoon of yogurt) and using solids (piece of bread). The evaluation of swallowing will involve four items: early spill of food (delayed triggering), aspiration, penetration, and retention (residue). And the results will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing tonsillectomy.
2. Age group (from 7-18 years).
3. Patients of either gender.

Exclusion Criteria:

1. Patients younger than 7 years or older than 18 years.
2. Patients with neurological diseases and genetic syndromes.
3. Patients with history of swallowing disorders prior to tonsillectomy.
Resilient Families

The goal is to develop, refine, and test the feasibility and acceptability of a dyadic, resiliency intervention ("Resilient Families;" R-FAM) that aims to reduce emotional distress and improve relationships among parents in the Neonatal Intensive Care Unit (NICU). To achieve this goal, my aims are three-fold: (1) develop R-FAM using stakeholder input from interviews with parent dyads and focus groups with NICU staff; (2) optimize R-FAM through an open pilot with pre/post assessments and exit interviews; and (3) test R-FAM for feasibility and acceptability through a randomized clinical trial of R-FAM compared with a minimally enhanced usual control (MEUC).


Eligibility Criteria:
Inclusion Criteria:

* Adult parent/legal guardian (and/or their partner) of a baby admitted to the NICU within past week (age ≥ 18)
* Currently in an intimate relationship and will live with baby after NICU discharge
* At least one dyad member is emotionally distressed (HADS \>7 on depression or anxiety subscale)
* English fluency/literacy
* Ability and willingness to participate via live video

Exclusion Criteria:

* Baby is expected to pass away (as determined by medical team)
* Current, untreated psychosis or substance dependence/abuse
* Current self-report of suicidal ideation
rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency

IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors to growth during infancy, childhood, and adolescence.

Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a type of growth hormone insensitivity and an inability to grow normally.

This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will help children with IGFD grow taller more quickly than children treated with rhGH alone. The study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH in children with IGF-1 deficiency (IGFD) is investigational.


Eligibility Criteria:
Inclusion Criteria:

* Parents or legally authorized representatives must give signed informed consent before any trial-related activities
* IGF-1 SDS of ≤ -1 for age and gender
* Short stature, as defined by a height SDS of ≤ -2 for age and gender
* Chronological age ≥ 5 years
* Bone age ≤ 11 years in boys and ≤ 9 years in girls
* GH sufficiency, defined as a maximal stimulated GH response of greater than or equal to 10 ng/mL at Visit 2 (note: upon approval of the Medical Monitor, the result of a prior GH stimulation test may satisfy this requirement).
* Prepubertal status
* Adequate nutrition as evidenced by a body mass index (BMI) greater than or equal to the 5th percentile for age and gender

Exclusion Criteria:

* Severe Primary IGFD (defined as height and IGF-1 SDS ≤ 3, and stimulated GH response greater than or equal to 10 ng/mL)
* Prior or current use of medications with the potential to alter growth patterns including GH, IGF-1, IGFBP-3, gonadotrophin agonists (e.g., Lupron), aromatase inhibitors, androgens and estrogens
* Known or suspected allergy to rhGH, rhIGF-1 or a constituent of their formulations
* Current use of medications for attention deficit disorder
* A chronic health condition that requires anti-inflammatory steroids or daily medication unless approved by the Medical Monitor