cyrilzakka/clinical-trials huggingface dataset:
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Pharmacokinetics parameters were regarded as exploratory parameters. Adverse event data will be covered in Adverse events section.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite optimized heart failure therapy

Exclusion Criteria:

* Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

The purpose of this study is to determine whether Valacyclovir treatment, administered during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection.

A randomized, double-blind, placebo-controlled study.

Participants: Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester

Intervention: After informed consent and randomization, participants in the treatment group will receive Valacyclovir at a dose of 8 g/d. Participants in the control group will receive the same amount of daily pills containing placebo. Treatment will continue until amniocentesis, which will determine if the fetus was infected.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester of pregnancy or periconceptionally

Exclusion Criteria:

* Patients with preexisting liver disease, renal dysfunction, bone marrow suppression or sensitivity to Acyclovir will be excluded from the study - as will patients receiving any antiviral therapy prior to the study.
Clinical Use of Prilocaine Chlorhydrate Among a General Surgical Population

Observation of the effects of an administration of prilocaine chlorhydrate hyperbare in rachianesthesia among a general surgical population.


Eligibility Criteria:
Inclusion Criteria:

* 500 consecutive patients with a spinal anesthesia

Exclusion Criteria:

* Patient's refusal
* Age \< 18 years
RADAR Clinical Trial

This prospective, multicenter, observational study will examine the ability of real time electrogram processing mapping to identify driver domains to target for ablation in persistent AF patients.

ABSTRACT: Recent clinical trials have shown that targeting rotors and focal impulses (FIs) during atrial fibrillation (AF) ablation improves outcomes. This study evaluated whether a novel computational mapping algorithm (CMA) could identify FIs and rotors, and characterize rotors when incidental ablation resulted in rhythm changes. Three-dimensional (3D) left atrial electroanatomic maps were created from signals recorded from multipolar circular mapping catheters in 61 patients undergoing persistent AF ablation. Forty of 61acquired patient datasets were of adequate quality for analysis CMA, employing an AF pattern recognition algorithm, creating 3D panoramic AF maps identifying drivers of AF (FI and rotors) post procedure. Rotors were further classified as substrate (SBR) or non-substrate based (NSBR) on the basis of rotor stability, proximity to voltage transition zones and complex fractionated atrial electrograms (CFAEs). Incidentally ablated identified AF drivers, including SBRs and NSBRs, were evaluated for rhythm changes. A total of 172 drivers were identified in 40 patients (2.2 drivers/patient). Seventy percent were rotors (120/172) and 30% were FIs (52/172). Sixty-seven percent of rotors were classified as SBR vs 33% as NSBR. Incidental ablation of SBRs resulted in rhythm change 91% of the time versus only 24% of the time for NSBR (p\<0.0001).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* Patients are considered eligible if they have symptomatic or drug-refractory AF and are planned to undergo a catheter ablation procedure for persistent AF (ether a first procedure or a redo procedure)
* Ability to understand the requirements of the study and sign the informed consent form.
* Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
* Projected lifespan greater than 1 year.

Exclusion Criteria:

* They have long-standing persistent AF prior to the first procedure (defined as AF greater than one year's duration).
* Rheumatic heart disease
* Current intra-cardiac thrombus
* History of MI or Coronary Artery Bypass Grafting (CABG) within 6 weeks
* Unstable angina
* CVA or TIA within 3 months
* Contraindication to anticoagulation
* Class IV HF
* Unable to sign consent
* Projected lifespan of \< 1 year
* Women known to be pregnant or to have positive beta-HCG (Human Chorionic Gonadotropin).
* Participation in another study that would interfere with this study.
Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients

Colorectal cancer (CRC) in Egypt is advanced tumors at diagnosis. Although, the dramatic increase in efficacy, reduction of mortality, and improvements in survival by the use of standard doses of chemotherapy, some CRC patients suffer from severe toxicities besides disease progression. Use of chemotherapy less than the maximum tolerated dose, with no prolonged drug free breaks incapacitates the cells to engage in progression mechanisms, suggesting that it could be a better alternative to standard dose therapy with better toxicity profile

This is a randomized phase II prospective study that included 70 (35 in each arm) metastatic Egyptian CRC cancer patients diagnosed at the National Cancer Institute, Cairo University between January 2016 and June 2018). Patients were randomly treated with either classic XELOX (arm A) or with capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg/m2 weekly X 8 weeks) then 2 weeks rest (arm B). Toxicities and the survival analysis after two years for both regimens were recorded. Blood samples are taken from both groups to assess pharmacokinetics of capecitabine and its relation to dosing.

Eligibility Criteria:
Inclusion Criteria:

* Patient age 18-70 years of both sexes.
* PS 0-2 and histologically proven mCRC with unresectable metastases (rectal cancer is included to left side cancers).
* They should have measurable lesions (that can be accurately measured in at least one dimension using calipers or ruler and measurement must be at least 20 mm using conventional techniques or 10 mm using spiral CT scan).
* No previous treatment for metastatic disease and had ended adjuvant treatment \> 6 months.
* peripheral neuritis less than grade 2.
* Normal organ functions:(Creatinine ≤1.2, Bilirubin ≤1.2, SGOT/SGPT\< 2N, HB \>9gm/dl, WBC\>3.5/dl with ANC \>1.5/dl, Plat ≥100/dl).
* For patients with liver metastases, Bilirubin should not be \>2.5N and transaminases not \>5N. (All patients were screened for HCV and HBS Ag by PCR).
* Adequate cardiac functions (EF\>55%)

Exclusion Criteria:

* patients with only ascites or bone metastasis
Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary objective is to evaluate any adverse events found during the clinical study.

Following data analysis will be conducted for tonometer and pachymeter readings. One of eyes of one patient becomes an object of the analysis. Regarding the intraocular pressure, higher IOP readings of either right or left eye are used for analysis. Regarding CCT, the readings of either right or left eye are randomly assigned to analysis in the order of registration.

Eligibility Criteria:
Inclusion Criteria:

1. IOP Measurement 1. 20 years or older who voluntarily agree to participate in this study after receiving adequate explanation 2. Possible to participate in the study regardless of existence of glaucoma
2. CCT Measurement 1. 20 years or older who voluntarily agree to participate in this study after receiving adequate explanation 2. Possible to participate in the study regardless of existence of glaucoma 3. Possible to participate in the study regardless of existence of corneal diseases (such as Keratoconus, post-LASIK, and corneal scars)

Exclusion Criteria:

1. IOP Measurement 1. Those with only one functional eye 2. Those with one eye having poor or eccentric fixation 3. Those with corneal scarring or who have had corneal surgery such as laser surgery 4. Microphthalmus 5. Buphthalmos 6. Contact lens wearers 7. Dry eyes 8. Blepharospasm 9. Nystagmus 10. Keratoconus 11. Those who have been diagnosed as having corneal conjunctivitis or other infectious disease 12. Those with central corneal thickness greater than 600 μm or less than 500 μm 13. A subject judged to be ineligible for participating in the study by the physicians in charge
2. CCT Measurement 1. Those with only one functional eye 2. Those with one eye having poor or eccentric fixation 3. Blepharospasm 4. Nystagmus 5. Those who have been diagnosed as having corneal conjunctivitis or other infectious disease 6. A subject judged to be ineligible for participating in the study by the physicians in charge
Spinal Versus General Anesthesia for Ambulatory Anesthesia

The purpose of this study is to describe, in real-life conditions, the factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) in outpatient surgery.

This is a cross-sectional, observational, prospective, multicentre study, conduct in France among a representative sample of anesthesiologists.

The factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) will be assessed in patients undergoing an outpatient surgery. Data will be collected by the physician during the inclusion visit (peripostoperative consultation). Additional data regarding the patient's perception (pain and satisfaction) will be collected using a self-questionnaire 7 days after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing an ambulatory surgery
* Patients for whom either a spinal anesthesia or a short general anesthesia is planned
* Patients accepting and able to complete a self-administered questionnaire in French language
* Informed patients who accept the computer processing of their medical data and their right of access and correction

Exclusion Criteria:

* Patients with contra-indications to elective ambulatory surgery
* Emergency surgeries
* Patient for which both spinal anesthesia and short general anesthesia coexist
* Patients with contra-indications to spinal anesthesia (due to surgical procedure site, comorbidities or patient's treatment)
* Patients participating or having participated in the previous month in a clinical trial in anaesthesiology
Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation.
* Measurable disease based on RECIST 1.1.
* Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥ 50% of tumor cells (tumor proportion score \[TPS\] ≥ 50%) as assessed by immunohistochemistry at a central laboratory.
* Life expectancy of at least 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

* Known untreated central nervous system metastases and/or carcinomatous meningitis.
* History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
* Symptomatic ascites or pleural effusion.
* Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Has had an allogeneic tissue/solid organ transplant.
* Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
* Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
* History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
* Use of protocol-defined prior/concomitant therapy.
Supine Sleeping After Total Hip Replacement

Aim of the current study is to test the non-inferiority hypothesis of differences in early hip dislocation between a group of patients who will be restricted to sleep in supine position and a group without restricted sleeping position during the first eight weeks after a total hip replacement following a posterolateral surgical approach

stratified block randomized controlled trial

Eligibility Criteria:
Inclusion Criteria:

* Placement of a primary total hip replacement via the posterolateral approach by a high volume orthopaedic surgeon
* Patients with a ASA-classification of I or II

Exclusion Criteria:

* Blindness
* Replacement of 2nd total hip within six months after the1st total hip replacement surgery
* Insufficient knowledge of the Dutch language
* Collum fracture
* Infection of total hip replacement
* Cognitive dysfunction
* Wheelchair dependability
* Hypermobility
* Alcohol abuse
* Neurological disorders such as Parkinson and stroke
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

1. 19 ≤ age ≤ 45
2. Health Volunteers
3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion Criteria:

1. Subject who cannot participate in a clinical trial based on the PI's judgment
Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)

This is a clinical trial with a cross over design investigating the effect of the proton pump inhibitor omeprazole on fat malabsorption in subjects with cystic fibrosis and pancreatic insufficiency. Participants will be randomized to receive either omeprazole or placebo for 28 days, then cross over and receive omeprazole or placebo for another 28 days. Markers of fat absorption will be measured after each treatment course.

Fat malabsorption contributes to poor nutritional status in people with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). Prescribing gastric acid-reducing agents such as proton pump inhibitors (PPIs) and histamine receptor antagonists (H2RAs) as an adjunct to pancreatic enzyme replacement therapy (PERT) to improve PERT efficacy and dietary fat absorption has become accepted clinical practice in CF, despite limited evidence to support the practice. Establishing the efficacy and true health benefit of acid suppression for nutritional status and outcomes in CF is particularly important in light of potential health risks and cost associated with long-term or even lifetime use of these medications.

This study aims to characterize changes in fat malabsorption using the coefficient of fat absorption (CFA) as the primary endpoint in subjects who are on and off acid suppression with a PPI in addition to PERT. Additionally, the SmartPill® will be used to evaluate duodenal power of hydrogen (pH) while on and off acid suppression, and the malabsorption blood test (MBT) will be used to characterize changes in fat absorption. Associations will be explored between changes in nutritional status (weight, height, BMI), clinical GI symptoms, and quality of life in subjects treated with PPI vs. placebo.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis and pancreatic insufficiency (Fecal elastase \<200 ug/g stool)
* Age ≥12 years
* In usual state of good health
* Willing to participate in a four-month study with three visits

Exclusion Criteria:

* Forced expiratory vital capacity at one second (FEV1) \<40% predicted
* Pregnancy or breast feeding
* Other illness affecting growth or nutritional status
* Unwillingness to continue their clinically established PERT dose for the duration of the study
* Use of other medication that affects dietary fat absorption
* Allergy to soy products
* Allergy to safflower products
* For subjects ≥18 years, celiac disease or allergy to gluten
A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC

The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib


Eligibility Criteria:
Inclusion Criteria:

* ECOG PS of 0 or 1
* Histologically confirmed NSCLC
* Adequate amount of tumor (archived or fresh) for biomarker evaluation
* Received one to two regimens of chemotherapy (with at least one platinum-containing)
* Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min
* Stable control of blood pressure on agents other than calcium channel blockers
* Women of child-bearing potential must avoid pregnancy or maintain adequate contraception
* Must be able to swallow pills and take the medications at the same time every day on an empty stomach

Exclusion Criteria:

* ECOG PS 2 or greater
* Women unwilling to avoid pregnancy or use adequate contraception
* Symptomatic brain metastases
* Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)
* History of hemoptysis greater than 10 mL/day
* Significant cardiovascular disease
* Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease
* History of use of other TKIs
* Uncontrolled hypertension
* HIV+
Avelox in Complicated Skin and Skin Structure Infections

This international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life treatment conditions. Specifically investigated are the improvement of clinical symptoms and the duration until infection improvement and cure.Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) treated with Avelox can be documented. The observation period for each subject covers the treatment period with Avelox. For each patient, the physician documents data at an initial visit and one or two follow-up visit(s) in line with routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) and for whom the decision was made by the attending physician to start treatment with Avelox before inclusion into and independent of the study.

Exclusion Criteria:

* Exclusion criteria are those specified in the local product information.
Nemaline Myopathy Clinical Research Network (NM-CTRN)

The goal of this study is to establish a research network to help define the natural disease history and clinical outcome measures for Nemaline Myopathy (NM).

The long-term aim of this study is to incorporate these outcome measures into clinical trials for NM therapies. Outcome measures to be assessed will be dependent on the participant's age and functional status. Follow-up visits will be conducted either every 3 or 6 months, dependent on age, for a total of 3 years.

Eligibility Criteria:
Inclusion Criteria:

* 0-18 years of age at recruitment
* Confirmation of Nemaline Myopathy (pathogenic or likely pathogenic mutations in ACTA1 (AD) or NEB (AR)
* Patient and/or parent or legal guardian must be willing and able to provide informed consent

Exclusion Criteria:

* Clinically significant medical finding on the physical examination, other than NM, that the Investigator deems unsuitable for participation in and/or completion of the study procedures
* Any confirmed chronic or acute condition or disease affecting any system(s), which could interfere with the results of the study and/or the compliance with the study procedures. This will be subject to the clinical judgement of the Principal Investigator (PI)
* Participants of ongoing (interventional) clinical trials that assess the efficacy of potential treatments will be excluded
* Safety concerns
Effects of Angiotensin Receptor Antagonist on Prohibiting Cardiovascular Events on Hemodialysis Patients

Cardiovascular disease is a leading cause of mortality in patients on hemodialysis therapy (HD), accounting for 30 to 50% of all death. Although angiotensin receptor blockers (ARBs) are effective for patients with diabetes and chronic kidney disease in reducing or preventing cardiovascular diseases, there has been no decisive study that demonstrated treatment with ARBs is effective in patients on HD.


Eligibility Criteria:
Inclusion Criteria:

* 30 to 80 years of age
* Receiving hemodialysis at least 12 months and less than 5 years
* Pre-dialysis systolic blood pressure was more than 160 mmHg, or more than 150 mmHg if the patients received antihypertensive agents.

Exclusion Criteria:

* Use of angiotensin receptor blocker or angiotensin converting enzyme inhibitor
Long-term Follow-up Study of Patients Receiving Onasemnogene Abeparvovec-xioi

This is a long-term follow-up safety and efficacy study of participants in clinical trials for spinal muscular atrophy (SMA) who were treated with onasemnogene abeparvovec-xioi. Participants will roll over from their respective previous (parent) study into this long-term study for continuous monitoring of safety as well as monitoring of continued efficacy and durability of response to onasemnogene abeparvovec-xioi treatment.


Eligibility Criteria:
Inclusion Criteria:

* Any participant with SMA who received onasemnogene abeparvovec-xioi gene replacement therapy in a Novartis Gene Therapies-sponsored clinical study
* Participant/parent/legal guardian willing and able to complete the informed consent process and comply with study procedures and visit schedule

Exclusion Criteria:

* Parent/legal guardian unable or unwilling to participate in the long-term follow-up safety study
The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction

The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

* presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
* ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage

Exclusion Criteria:

* hemodynamic instability
* history of MI
* old age \> 80years
* Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)