cyrilzakka/clinical-trials huggingface dataset:
Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN)

The study will assess the atrial fibrillation burden recorded By implantable loop recorder at 12 and 24 months compared to baseline. The patients with clinical indication fo catheter ablation of paroxysmal atrial fibrillation will be randomized to three techniques: manual radiofrequency ablation, radiofrequency ablation using remote magnet monitoring, and cryoablation.

A total of 300 patients will be randomized to three different catheter ablation techniques (100 patients/group); radiofrequency ablation using remote magnet navigation, radiofrequency ablation using manual method, and cryoablation. A loop recorder (REVEAL) is implanted one month before the catheter ablation of paroxysmal atrial fibrillation and the effects of atrial fibrillation burden will be compared between the three methods at 12 and 24 months after ablation excluding the first three months´ blanking period.

The primary endpoints are:

1. the proportion of patients remaining free from atrial fibrillation, atrial flutter or atrial tachycardia (\> 2 minutes) recorded by the implantable cardiac monitor (Medtronic) at 24 months follow-up and
2. total atrial fibrillation burden recorded by the loop recorder.

Other endpoints:

1. Atrial fibrillation burden in 7 days Holter recording at 12 and 24 months compared to baseline,
2. the time to first documented symptomatic and asymptomatic recurrence of atrial fibrillation
3. prescription of antiarrhythmic drugs after the 3 months blanking period following the ablation
4. re-ablation after the index ablation procedure,
5. total procedural duration;
6. total time of fluoroscopy and radiation dose;
7. number and duration of cardiovascular hospitalization;
8. quality of life questionnaires at 12 months and 24 month compared with baseline,
9. cognitive function at 12 and 24 month compared with baseline,
10. cost-efficacy of the different ablation techniques.

Eligibility Criteria:
Inclusion criteria:

* Patients with symptomatic paroxysmal atrial fibrillation fulfilling the contemporary guideline criteria for AF ablation

Exclusion Criteria:

- Any contraindication to catheter ablation
Single Dose PG102 in Patients With Active Psoriatic Arthritis

The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.


Eligibility Criteria:
Inclusion Criteria:

* Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria
* Plaque psoriasis for at least 6 months prior to study enrollment

Exclusion Criteria:

* Clinically significant psoriasis flare
* Unstable doses of pain relief medication
* Treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or equivalent
* Treatment with any biologic therapy
* Treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate
* Treatment with lithium, any anti-malarial, chlorambucil, cyclophosphamide or therapies for psoriasis other than low potency topical corticosteroids on intertriginous and groin areas, tar or salicylate preparations on the scalp, and emollients and moisturisers
* Family history of multiple thrombotic events or a personal history of any venous or arterial thrombotic event
* Clinically significant result for anti-cardiolipin, Activated protein C resistance test, Protein C, Free Protein S, Antithrombin III, Factor V Leiden, Prothrombin variant, Homocysteine, Lupus anticoagulant, Prothrombin time, Activated partial thromboplastin time, Fibrinogen, Thrombin time, Factors IX and XI
* Currently smoking ≥ 10 cigarettes per day or equivalent
* Active tuberculosis or other infection
* Current or previous malignancies
* Clinically significant abnormality on physical examination, laboratory testing, vital signs or 12-lead electrocardiogram
Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma

This clinical trial studies genetic biomarkers from saliva samples in patients with Ewing sarcoma. Studying samples of saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. To determine the association between the length of Ewing sarcoma breakpoint region 1-Friend leukemia virus integration 1 (EWS-FLI1) fusion protein binding sites (microsatellites) and risk of Ewing's sarcoma (ES).

II. To determine the frequency and commonality of Caucasian ancestral markers in cases of ES self-identified as non-Caucasian (African-American, Asian, Hispanic).

III. To determine the association between genomic variants in ES-related genes and hernia development (i.e. the integrin signaling pathway) and risk of ES.

OUTLINE:

Genomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes.

Eligibility Criteria:
Inclusion Criteria:

* The patient is enrolled on ACCRN07
* The patient has a diagnosis of Ewing Sarcoma (International Classification of Diseases \[ICD\] code morphology 9260; topography C40.0-C41.9, C76.0-C76.8, C80.9) and is registered with Children's Oncology Group (COG) by a North American member institution
* The patient must be diagnosed with Ewing sarcoma between December 24, 2007 and December 31, 2015
* The patient must have at least one biological parent alive and willing to participate
* All questionnaire respondents must understand English or Spanish
* Concomitant treatment on a therapeutic trial is not required
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])

This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).

Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.

From the date of successful completion of Study ALK21-006 (base study \[NCT01218997\])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study.

Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy. If the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.

Eligibility Criteria:
Primary Inclusion Criteria:

* Adults with a diagnosis of alcohol and/or opioid dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) who had satisfactorily completed Alkermes' Study ALK21-006 or other qualifying Medisorb naltrexone study
* Willing and able to return for scheduled clinic visits and study assessments
* Had a stable address
* Agreed to use a contraception for the duration of the study and for 1 month following the last dose if of childbearing potential
* Written informed consent

Primary Exclusion Criteria:

* Pregnancy or lactation
* Terminated early from study drug in a previous Medisorb naltrexone clinical trial
* Any finding that, in the view of the investigator, would compromise the ability to fulfill the protocol visit schedule and/or visit requirements
Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia

The purpose of the study is to learn if a blood test is helpful to the doctors in deciding whether you need antibiotic therapy for possible pneumonia. The blood test is called a Procalcitonin level and sometimes the test reflects infection with certain bacteria (germs). When the doctors learn the results of these blood tests, they may be able to stop some of the antibiotic medications that they may have given to the patients. The study is designed, so that on a randomized basis (50/50 chance) the results from measuring Procalcitonin will be given to the patients' doctor. When the doctor receives these results, he/she may use this information, along with other information, to decide whether to continue antibiotic therapy.

To evaluate the usefulness of serum Procalcitonin level measured to guide the antibiotic treatment of patients with radiographic lung infiltrates.The subjects involved in the study will be divided in two arms ,study arm where the caregivers will know the result of Procalcitonin level and they can change /withheld the antibiotic for the subjects.In other arm only investigators will know the Procalcitonin level. We expect to enroll 100 patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* New radiographic findings consistent with the presence of infiltrates
* Antibiotic therapy

Exclusion Criteria:

* Critically ill patients on admission
The Study of Abatacept in Combination With Etanercept

The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.


Eligibility Criteria:
Inclusion Criteria:

* All subjects who had completed the short term portion of IM101-101.
Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)

This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related donor. An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-60 years of age
* Candidate for a living-donor renal allograft from an HLA mismatched donor
* First or second transplant with either a living donor or cadaveric transplant as the first transplant.
* Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation.
* Ability to understand and provide informed consent.
* Serologic evidence of prior exposure to EBV.

Exclusion Criteria:

* ABO blood group-incompatible renal allograft.
* Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by routine methodology (AHG and/or ELISA)
* Leukopenia or thrombocytopenia.
* Positive for HIV-1, hepatitis B core antigen, or hepatitis C virus; or positivity for hepatitis B surface antigen.
* Cardiac ejection fraction \< 40% or clinical evidence of insufficiency.
* Forced expiratory volume FEV1 \< 50% of predicted.
* Lactation or pregnancy.
* History of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
* Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type I or II membranoprolifertive glomerulonephritis).
* Prior dose-limiting radiation therapy.
* Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen.
* Enrollment in other investigational drug studies within 30 days prior to enrollment.
* Abnormal (\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
* Allergy or sensitivity to any component of belatacept, ATG, tacrolimus, or rituximab.
* Maintenance immunosuppression within 3 months prior to conditioning other than physiological doses of steroids, defined as ≤ 50 mg of hydrocortisone or dose equivalent.
* The presence of any medical condition that the investigator deems incompatible with participation in the trial.
Gestational Diabetes in Central Asia: Prevalence and Management

Evaluate prevalence and management of gestational diabetes in Tajikistan in two different settings (one rural and one urban).


Eligibility Criteria:
Inclusion Criteria:

* pregnancy

Exclusion Criteria:

* known diabetes mellitus
A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food

Single Rising Dose (SRD) part:

The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral administration of single rising doses.

Food Effect (FE) part:

The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
* Age of 18 to 45 years (inclusive).
* Body mass index (BMI)of 18.5 to 29.9 kg/m2 (inclusive).
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm).
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular liver enzymes (AST/ALT) above upper limit of normal and creatinine exceeding 1.2 mg/dl as confirmed by repeat measurements.
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair).
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
* History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply.
Sleep Disorders in Idiopathic Pulmonary Fibrosis

This diagnostic observational study was conducted to (1) investigate the prevalence of sleep-related breathing disorders and other sleep disorders in idiopathic pulmonary fibrosis in comparison to COPD, (2) identify characteristics of symptomatic and prognostic significance in idiopathic pulmonary fibrosis with/without sleep disorders, and (3) evaluate different tools for their ability to assess the risk of co-existing sleep disorders in idiopathic pulmonary fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* written informed consent
* IPF cohort: Documented history of IPF with definite or possible UIP pattern and signs of emphysema below 10% by HRCT (IPF diagnosis according to 2011 ATS/ERS IPF guidelines)
* COPD cohort: Documented history of COPD Stage II Group A or B, Stage III or IV, Group C or D (GOLD 2014)

Exclusion Criteria:

* Long-term oxygen therapy
* Heart failure NYHA stages III and IV
* Left ventricular ejection fraction ≤ 45%
* Pregnancy and/or lactation
* Acute and/or life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, malignant tumor requiring treatment)
* Current drug or alcohol abuse
* Any medical, psychological or other condition impairing the patient's ability to provide informed consent
* IPF cohort: Acute exacerbation of IPF
* IPF cohort: Concomitant lung/airway diseases other than IPF (signs of emphysema \>10% by HRCT)
* COPD cohort: Acute exacerbation of COPD
* COPD cohort: Concomitant lung/airway diseases other than COPD (e.g. Asthma bronchiale)
* Healthy cohort: Documented history of structural airway or lung disease
Effect of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin

Abnormal uterine bleeding is characterized by excessive menstrual blood loss affecting over 50% of women of reproductive age. It can be debilitating and significantly affect a woman's quality of life. Tranexamic acid (TXA) prevents the breakdown of clots and fibrinolysis by binding to the lysine receptor on plasminogen while Calcium dobesilate improves microcirculation and vascular health by increasing nitric oxide synthesis leading to endothelium relaxation, so inhibits endothelial shedding. Calcium dobesilate and tranexamic acid have roles in managing bleeding disorders, but their use and efficacy can vary. Tranexamic acid is more established and widely used for abnormal bleeding, while calcium dobesilate role is less defined and more variable. Tranexamic acid reduces menstrual blood loss, but it has no affect on endothelium while calcium dobesilate reduces the oxidative stress , so improving endothelial health and provide the endothelial protection. Side effects include GI upset , hypersensitivity reactions and agranulocytosis. The side effects of both drugs are comparable.

This Randomized control trial was conducted at Obstetrics \& Gynaecology unit Sahiwal Teaching Hospital from to for the period of two years after taking the approval from Institutional review board (IRB). Sample size of one hundred patients (Fifty in each group) was calculated. These patients were randomly allocated into two equal groups, fifty patients in each group. Written informed consent was obtained from each subject by explaining the risks and benefits associated with the drugs. Group A women were given 500mg tranexamic acid thrice a day for 5 days during menstrual cycle and in group B women were given 500 mg capsule Calcium dobesilate thrice a day for 5 days during menstruation for consecutive time period of three months. Women were also evaluated for adverse effects. The information was entered into specially designed proformas. The data was analyzed by SPSS version 21.0. Frequencies and percentages of categorical variables including marital status, parity and adverse effects were calculated and compared between two groups by applying chi square tests. t-Test was used for the calculation of mean and standard deviations of numerical variables like age, BMI, duration of symptoms, blood loss before and after intervention and reduction in blood loss and was compared between two groups. In all statistical analysis only p value less than 0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Women of 18-40 years
* Abnormal uterine bleeding

Exclusion Criteria:

* Patients with pregnancy
* Miscarriage
* Hypersensitivity to pharmacological agents to be used in trial
* Patients having moderate to severe anemia (Hb:\<8gm/dl)
* Patients with thyroid abnormalities (TSH \> 5mIU)
* Benign uterine conditions e.g. fibroid uterus, endometrial/cervical polyp
* Uterine malignancy
* Coagulation disorders (PT : \>15sec).
Uptake to Colorectal Cancer Screening in Familial-risk Population

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients diagnosed of CRC.

The recruitment process will be programmed through the index case, that will be interviewed to obtain their CRC family history. FDR will be contacted in order to make an appointment in the High-risk CRC Clinic of the participant centers. Randomization will be performed before signing the informed consent to avoid selection bias. A researcher will be responsible to provide detailed information about the study and getting the informed consent. In case of willingness to participate in the study, the FDR will be randomized to one of the following arms: A) One-time colonoscopy; B) annual FIT for two screening rounds and a colonoscopy in case of a positive FIT (cut-off = 10 μg Hemoglobin/g feces). Screening uptake will be defined as the percentage of FDR who participate at least in one of the two FIT screening round in the FIT group or who undergo colonoscopy in the other group. Screening uptake will be calculated under the assumption of intention to screen analysis.

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.

Eligibility Criteria:
Inclusion Criteria:

1. FDR with a case index meeting the following conditions: at least one case index \< 60 years at diagnosis of the CCR;
2. having ≥ 2 FDRs with CRC regardless the age of the case index at diagnosis;
3. having a sibling with CRC;
4. age \<75 years.

Exclusion Criteria:

1. past CRC screening;
2. inflammatory bowel disease or past history of colorectal neoplasia;
3. Family history of hereditary CRC;
4. Abdominal symptoms;
5. Colectomy;
6. Severe comorbidity leading to a poor prognosis (life expectancy \< 5 years);
7. Refusal to participate in the study.
Lateral Position MRI in Preterm Infants, an Observational Study

The goal of this observational study is to evaluate safety of sedation in lateral position in premature babies undergone MRI. The main question it aims to answer are:

* number of apneas during sedation
* Maintenance of eupnea during deep sedation

Premature babies will be sedated in lateral position during Magnetic Resonance Imaging. During procedure we provide a close control about eupnea maintenance (SaO2 and EtCO2) in order to verify the safety of laying.

Eligibility Criteria:
Inclusion Criteria:

* \< 40 weeks Post Conceptional Age (PCA)

Exclusion Criteria:

* \> 50 weeks PCA
* previous treatment with hypothermia for neonatal asphyxia
* patients who received invasive positive pressure ventilation within the previous 48 h
* preexisting cardiac arrhythmias
* presence or suspicion of oncological pathology
* neuromuscular or metabolic diseases
* previous brain or abdominal surgery
* presence of epicranial venous accesses
* upper respiratory tract infections
* refusal of informed consent by parents or inability to express it