cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)

To investigate the safety, pharmacokinetics and pharmacodynamics of TS-143 when administered 3 times a day for 10 days to healthy Japanese adult males using placebo-controlled, double-blind, dose escalation study design.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a BMI of 18.5 to less than 25.0 at the time of the screening tests
* Subjects judged by the principal investigator or a subinvestigator to be appropriate for participation in the study based on the results of the screening tests and the tests conducted before the investigational drug treatment on Day 1
* Subjects capable of receiving an explanation of this study before participation, understanding the details, and providing written informed consent themselves

Exclusion Criteria:

1. Subjects meeting any of the following criteria in the results of screening tests, tests conducted on the day before the first investigational treatment (Day -1), and tests conducted before the investigational drug treatment on the morning of Day 1:

   * Red blood cell count: ≥535 × 10\^4 /μL
   * Hemoglobin: ≥16.2 g/dL
   * Hematocrit: ≥47.5%
   * Reticulocyte rate: Outside of the reference value range
2. Subjects meeting any of the following criteria in the screening tests:

   * Serum EPO concentration: Outside of the reference value range
   * Ferritin: ≤30 ng/mL or \>upper limit of the reference value
3. Subjects meeting any of the following criteria in the vital signs in the screening tests and the tests conducted before the investigational drug treatment on the morning of Day 1:

   * Blood pressure: Systolic blood pressure ≥140 mmHg, or diastolic blood pressure ≥90 mmHg
   * Pulse rate: \<40 bpm, or ≥100 bpm
   * Body temperature: ≥37.5°C
CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors

To assess the anti-tumor activity of CAP7.1 based on the observed objective response rate and rate of disease stabilization, as defined by the below primary and secondary endpoints, in patients with Non-Small Cell Lung Carcinoma (NSCLC), SCLC or biliary cancer who have progressed despite one or more previous chemotherapy line.

A phase II evaluation will be performed in adult patients in parallel studies in 3 tumor types: NSCLC, SCLC and Biliary Tract Cancer. All patients will have advanced or metastatic disease with primary or secondary resistance to standard therapy. In each tumor type the patients will be randomized to receive either therapy with CAP7.1 or best supportive care according to institution standards. Patient in the Control group who progress may cross over to CAP7.1, however these patients will be analyzed separately from the patients randomized to CAP7.1.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically-confirmed, advanced disease with documented progression (RECIST1.1.) after one or several chemotherapy line
* Patients may also have received molecular targeted therapy and progressed while on therapy or after completion
* Must have recovered from the acute reversible effects of previous anti-cancer chemotherapy, usually 3-4 weeks after myelosuppressive chemotherapy

Exclusion Criteria:

* Serious concurrent medical condition, which could affect compliance with the protocol or interpretation of results.
* Patients with uncontrolled infection and patients known to be infected with the human immunodeficiency virus (HIV) or hepatitis infection are not eligible for the study
* Pregnancy or breast-feeding
The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.

This open-label, randomized, two-arm, phase 2 study has the primary objective of comparing the ORR obtained with Chidamide+Decitabine+Camrelizumab against that obtained with Decitabine+Camrelizumab in patients with Hodgkin Lymphoma who were confirmed resistant to Anti-PD-1 antibody therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
2. 12 to 75 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
6. Subjects must have received Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month.
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies

The primary objective is to evaluate long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.

This study was initiated and the protocol was registered by Ionis Pharmaceuticals, Inc.

In August 2016, Biogen assumed responsibility for this study.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent of parent or guardian and signed informed assent of participant, if indicated per participant's age and institutional guidelines.
* Completion of the index study in accordance with the study protocol or as a result of Sponsor decision (e.g., early termination of the index study) within the preceding 16 weeks

Key Exclusion Criteria:

* Have any condition or worsening condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study
* Clinically significant abnormalities in hematology or clinical chemistry parameters or electrocardiogram (ECG), as assessed by the Site Investigator, at the Screening visit that would render the participant unsuitable for participation in the study
* Participant's parent or legal guardian is not willing or able to meet standard of care guidelines (including vaccinations and respiratory syncytial virus prophylaxis if available), nor provide nutritional and respiratory support throughout the study
* Treatment with another investigational agent, biological agent, or device within one month of Screening, or 5 half-lives of study agent, whichever is longer

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

Primary percutaneous coronary intervention represents the gold standard for the treatment of ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are associated with an increased risk of mortality, re-infarction, and stroke. Although the prognostic value of access site related bleeding complications is still debated, transradial approach is associated with better short-term outcomes and reduced hospital stay as compared to transfemoral approach. The investigators aimed to compare transradial approach with transfemoral approach with systematic achievement of hemostasis by the implantation of a vascular closure device in a national multicentre randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
* Intention to perform primary percutaneous coronary intervention;
* Signed informed consent;
* Patient eligible for transradial and transfemoral primary percutaneous coronary intervention, being pre-requisites: (a) familiarity of the operator with the radial and femoral techniques using vascular closure devices, (b) agreement of the operator to use the access route determined by the randomization process.

Exclusion Criteria:

* Less than 18 years of age;
* Pregnancy;
* Chronic use of vitamin K antagonists or direct thrombin inhibitors, or oral Xa-factor antagonists;
* Hypersensitivity to antiplatelet and/or anticoagulant drugs;
* Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance \< 30 mL/min, platelets count \< 100.000 mm3);
* Uncontrolled systemic hypertension;
* Cardiogenic shock;
* Previous myocardial revascularization surgery with ≥ 1 internal mammary or radial artery graft;
* Documented chronic peripheral arterial disease preventing the use of the femoral technique;
* Severe concomitant disease with life expectancy below 12 months;
* Participation in drug or devices investigative clinical trials in the last 30 days;
* Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.
VerifyNow French Registry

The purpose of this study is to determine the effect of clopidogrel or aspirin reactivity as measured by a point-of-care platelet function assay on thrombotic or bleeding events after percutaneous coronary intervention (PCI) with drug eluting or bare metal stent.

Methods:

Platelet reactivity on clopidogrel and aspirin therapy is measured before PCI with VerifyNow (Accumetrics Inc.,San Diego, CA, USA) P2Y12 or aspirin assay respectively in 1000 consecutive patients from 20 centers in France undergoing coronary angioplasty with stent.

Exclusion criteria are:

Acute myocardial infarction, treatment with vitamin K antagonists and the use of antiGP2b3a before PCI. All patients are pre-treated with clopidogrel and aspirin. Non-response to aspirin or clopidogrel is determined according to the result of the VerifyNow assay (cut off : \< 15 % for P2Y12 and \> 550 ARU for aspirin). The primary end point is the occurrence of definite or probable stent thrombosis (ARC definition) and the secondary end-points include global and cardio-vascular mortality, non fatal myocardial infarction and major bleeding. A clinical evaluation is scheduled at discharge and by telephone contact at one month and one year.


Eligibility Criteria:
Inclusion Criteria:

* Coronary angioplasty with stent

Exclusion Criteria:

* Use of AGP2b3a
* Acute myocardial infarction
* No aspirin and clopidogrel pretreatment
* Use of AVK
* Aspirin or clopidogrel contre-indication
Provocative Tests for HFpEF

Diagnosing heart failure with preserved ejection fraction (HFpEF) in patients complaining exertional breathlessness can be challenging: diagnostic algorithms and scores have low sensitivity, and ageing-associated comorbidities can complicate the interpretation of symptoms. Thus, exercise right heart catheterization (RHC) or invasive cardiopulmonary exercise test (iCPET) have been advocated as gold-standard methods for HFpEF diagnosis. However, exercise RHC and iCPET are still not widely standardized methods, with results mainly coming from US cohorts (that may differ from Italian cohorts), and other provocative tests (e.g. non-invasive CPET, passive leg raising) may offer complementary diagnostic information.


Eligibility Criteria:
Inclusion Criteria:

* dyspnea

Exclusion Criteria:

* known HFpEF
MGB/OAGB and LSG Effects on Lower Esophageal Sphincter (LES) Function

Background While several articles have reported about the effects of laparoscopic sleeve gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is expected to be the first randomized trial exploring and comparing these two interventions.

Setting "Federico II" University Hospital, Naples - ITALY.

Methods Fifty morbid obese patients are going to be studied. All patients presenting with a normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and 24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or MGB/OAGB.

Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss?


Eligibility Criteria:
Inclusion Criteria:

* 80 morbid obese patients are going to be studied. All patients presenting with a normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 40 pts) or MGB (arm 2 - 40 pts).-

Exclusion Criteria:

* Patients lost at follow up. Cancer patients at any stage.
Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Diabetic Neuropathy

This study are to:

* Evaluate effect of magnetic therapy on peripheral neuropathy in diabetic patients.
* Evaluate effect of laser therapy on peripheral neuropathy in diabetic patients.
* Compare effects of magnetic therapy with that of laser therapy on peripheral neuropathy in diabetic patients.

Sixty- five male and female diabetic patients with peripheral neuropathy will be selected to participate in this study. They will be equally divided into two groups Group-I: Twenty five patient with diabetic peripheral neuropathy will be exposed to low intensity pulsed magnetic therapy Group-II: Twenty five patients with diabetic peripheral neuropathy will be exposed for 24 treatment sessions of laser therapy Group-III 15 patient received only medical treatment

Eligibility Criteria:
Inclusion Criteria:

* All diabetic patients with peripheral neuropathy will be selected to participate in this study.
* Their age ranges from 35 to 65 years old.
* All patients under medical control (optimal blood glucose). such as analgesic medications (e.g. opiates, anti-depressants, anticonvulsants and diabetic drugs to control blood glucose).

Exclusion Criteria:

* Patients have DPN due to other causes than diabetes
* Ulcers in either foot
* Lack of blood sugar control
* Other nervous system impairments
* Visual problems
* Unstable medical conditions
* Pregnancy
* Metallic implants
* Alcohol or drug abuse.
Single Rising Oral Doses of BI 207127 NA as Powder in the Bottle in Healthy Male Subjects

The objective of this trial was to investigate the safety, tolerability, pharmacokinetics, and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral dosage form (tablets) without and with food.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
* Age ≥18 and Age ≤50 years
* BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nerve system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts.
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial.
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Inability to refrain from alcohol on trial days
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
* Baseline prolongation of QTc interval \>450 ms
* A history of additional risk factors for TdP (Torsades de points) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Intravenous Access Using Infrared Laser

Peripheral venous access is a prerequisite for anesthesiological for surgical patients.It is often difficult to establish and potentially painful in obese patients (Body mass Index \> 35). AV300 uses near infrared laser light to improve visibility of peripheral veins and could help cannulating them. The aim of this study was to examine if use of Accuvein(®) AV300 vein viewer could facilitate venous cannulation in obese patients (surgical and obstetric).


Eligibility Criteria:
Inclusion Criteria

* \> 18 years
* surgery that need double intravenous perfusion

Exclusion Criteria:

* \< 18 years
* body mass index\< 35
* refusal
* minor surgery that need only one intravenous access
Massachusetts General Hospital Evaluation of DePuy ASR Hip System

DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a higher than expected revision rate reported in the England/Wales and Australian national joint registries. There are two types of ASR hip implants used for total hip replacement surgery:

* ASR XL Hip System
* ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the study sponsor. MGH is conducting this study with the help of funding from DePuy Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects around the world. The countries include the United States of America, Australia, South Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH will analyze the data annually for 6 years.

The purpose of this study is to follow patients who have the ASR hip system for the next 6 years. The findings of this study may help surgeons to make better informed decisions about monitoring and treatment of patients with ASR hip systems.

Description of the Subject Population:

* Adults who have previously undergone a surgery implanting the DePuy ASR XL Acetabular Hip System or ASR Hip Resurfacing System;
* ASR patients who are already being followed-up by their surgeon at least once a year. This routine follow-up care consists of a clinic visit, blood tests, X-rays and possibly an MRI, Ultrasound or CT scan.

Eligibility Criteria:
Inclusion Criteria

1. Any patient with on-label use of the ASR-XL or ASR component system currently implanted.
2. Able to provide informed consent previously approved by institution's Institutional Review board (IRB) or ethics committee (EC).
3. Able to return for follow-up.
4. Able to complete the required patient reported outcome measures.

Exclusion Criteria

1. Any patient with off-label use indications for the ASR-XL or ASR component system.
2. Any patient who received the ASR-XL implant as a result of a hip resurfacing conversion or a revision THA.
3. Subjects with difficulty in comprehending the Informed Consent Form for any reason.
4. The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, or the medical office staff.
A Study of LY2605541 Versus Insulin Glargine on Blood Sugar

LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.


Eligibility Criteria:
Inclusion Criteria:

All Participants

* Are healthy males or participants with T1DM
* Have a screening body mass index (BMI) of 20.0-29.9 kilograms per square meter (kg/m\^2)

Healthy Participants ONLY

* Are overtly healthy, as determined by medical history and physical examination
* Have a fasting blood glucose \<108 milligrams/deciliter (mg/dL) (6.0 millimoles/liter \[mmol/L\]) at screening

Participants with T1DM ONLY

* Have a diagnosis of T1DM for at least 1 year based on medical history
* Have a screening c-peptide \<0.5 nanograms/milliliter (ng/mL)
* Have a hemoglobin A1c (HbA1c) of 6.0 to 9.0% at screening
* Have had no episodes of severe hypoglycemia in the past 6 months

Exclusion Criteria:

All Participants

* Have a hemoglobin level \<12.0 grams/deciliter (g/dL)
* Are currently a smoker, used tobacco products on a regular basis in the 6 months prior to screening, or are intending to smoke during the study

Healthy Participants ONLY

• Regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen).

Participants with T1DM ONLY

* Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
* Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing
* Require a total daily insulin dose exceeding 100 units (U)
* Have fasting triglycerides \>400 mg/dL