cyrilzakka/clinical-trials huggingface dataset:
Effects of Gastric Bypass on Blood Levels of Duloxetine

This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between the ages of 18 and 60 years.
* Subjects must be of good general health by history and physical exam.
* Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y procedure), no BMI requirement.
* Ten normal control subjects who have met the inclusion criteria and have not received bariatric surgery and who are matched to the surgery subjects according to body mass index, age and sex.
* Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
* No contraindications to receiving a single capsule of 60 mg of duloxetine

Exclusion Criteria:

* Allergy to duloxetine or any of its constituents.
* Candidates who are pregnant or nursing
* Candidates currently receiving any antidepressant.
* Candidates that are determined to be poor metabolizers for CYP2D6
* Subjects who smoke or use any nicotine products
* Candidates currently receiving a medication that interacts with duloxetine.
* Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.
* Candidates experiencing or with a history of vomiting or diarrhea associated with bariatric surgery
* Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder.
* Candidates who have participated in an investigational drug study in past 30 days.
* Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD/MAD)

To evaluate the safety,tolerability and pharmacokinetics of single-multiple intravenous doses of FL058 in healthy Chinese subjects.

This study is divided into two parts: A and B.Part A discusses the safety and tolerability of IV FL058 single ascending dose (SAD) in two cohorts. Part B discusses the safety and tolerability of intravenous injection of FL058 in multiple dose (MAD) in three cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged between 18 and 45 years (inclusive).
2. Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.
3. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
4. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.

Exclusion Criteria:

1. Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.
2. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.
3. History of clinically significant food or drug allergy.
4. A QT interval corrected using Fridericia's formula \>450 msec.
5. eGFR\<90mL/min/1.73m2.
Multi-center Study on Surgical or Non-surgical Treatment for Children Type 1 Humeral Condyle Fracture

The study evaluates the effectiveness of surgical or non-surgical treatment for children type 1 humeral condyle fracture.Half of the participants receive surgical treatment and the other half receive non-surgical treatment


Eligibility Criteria:
Inclusion Criteria:

Children Type 1 humeral Condyle Fracture，Fracture displacement less than 2mm

Exclusion Criteria:

Other type humeral Condyle Fracture
Dynamic EchoCardiographic Optimisation REsponse Study

The aim of this study is to evaluate the effects of heart rate optimization and guided A-V and V-V delay from color Doppler echocardiography, in subjects affected by heart failure with reduced ejection fraction and CRT-D device wearers who did not respond to device implantation in clinical, electrophysiological, and other terms.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be 18 to 85 years of age inclusive, at the time of signing the informed consent form;
2. Heart failure with ventricular ejection fraction left \<45%;
3. Presence of CRT-D devices in a non-responder patient for cardiac resynchronization
4. NYHA \>II;
5. Resting heart rate \<65 beats per minute;
6. Biventricular pacing \>97%.

Exclusion Criteria:

1. Age \<18 and \>85 years;
2. Insufficient functional capacity to complete the tests required by the research protocol;
3. Permanent Atrial Fibrillation
Safety and Effect of Elbasvir/Grazoprevir Combination Therapy in Hemodialysis Patients With Chronic Hepatitis C

The number of hemodialysis patients with chronic renal failure in Japan exceeds 0.3 million and is showing an increasing trend. The rate of infection with hepatitis C virus (HCV) is high in hemodialysis patients, and it has been revealed that the prognosis is poorer in HCV-infected hemodialysis patients compared to uninfected patients; therefore, aggressive therapeutic intervention is required.Investigator previously reported the efficacy and safety of a NS5A inhibitor; daclatasvir and a HCV protease inhibitor; asunaprevir combination therapy for Japanese dialysis patients with genotype 1 HCV infection. However, the duration of the treatment is 24 week, which is quite longer than current standard 12 week therapy .

elbasvir/grazoprevir combination therapy is oral anti-HCV 12 week therapy without the use of IFN/ribavirin, and a good therapeutic effect has been reported in Japanese phase II studies . Of note is that these drugs are metabolized mainly in the liver and thus they can be used in patients with chronic renal failure. Recently, David Roth et al reported that the efficacy and safety of elbasvir/grazoprevir combination therapy for patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease. In this report, they revealed that elbasvir/grazoprevir combination therapy could achieve SVR rate of 99% in the modified full analysis set.

However, no adequate clinical investigation has been performed in Japan, thus far concerning the therapeutic effect and safety of elbasvir/grazoprevir combination therapy in Japanese hemodialysis patients.


Eligibility Criteria:
Inclusion criteria

* Patients aged 20 years or older at the time of consent
* Patients who received an adequate explanation prior to the study and provided written consent for participation in the study
* Hemodialysis patients complicated by chronic hepatitis C who have HCV Genotype 1b infection and do not meet the exclusion criteria listed in the following section

Exclusion criteria

* Patients with a past history of hypersensitivity to HCV protease inhibitors and NS5A inhibitors
* Patients with serious liver dysfunction (Child-Pugh Class B or C)
* Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia)
* Patients who have malignant tumors, including hepatoma, at the start of treatment
* Patients on treatment with drugs listed in the contraindications for coadministration in the package insert (e.g., some antifungals, some antiepileptics, and human immunodeficiency virus (HIV) protease inhibitors)
* Patients with albumin \<3.0 g/dL and platelets \<75,000 /μL
* Other patients judged to be inappropriate to participate in the study by the primary physician
* Other patients judged to be inappropriate as study subjects by the study manager
Pragmatic Investigation of optimaL Oxygen Targets Trial

Mechanical ventilation of ICU patients universally involves titration of the fraction of inspired oxygen (FiO2) to maintain arterial oxygen saturation (SpO2). Despite decades of ICU practice, however, the optimal SpO2 target remains unknown. Current guidelines offer divergent recommendations as to the optimal SpO2 target. Therefore, we propose a 2,250-patient cluster-randomized cluster-crossover trial comparing a lower SpO2 target (90%; range 88-92%), an intermediate SpO2 target (94%; range 92-96%), and a higher SpO2 target (98%; range 96-100%) with regard to the outcome of days alive and free of invasive mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Receiving mechanical ventilation through an endotracheal tube or tracheostomy
3. Admitted to the study ICU or admission to the study ICU from the emergency department is planned

Exclusion Criteria:

1. Known pregnancy or beta hCG level greater than the laboratory upper limit of normal in a patient capable of becoming pregnant
2. Known to be a prisoner
H2O VR for Burns 2015

This study is designed to find additional methods to reduce pain during wound care. In this study the investigators use virtual reality (a form of distraction) in addition to pain medication during a burn wound care.

This study will employ a randomized within-subjects design. There are three different conditions in this study. By randomization, the participants will experience at least two of the conditions and likely all three, depending on the number of their wound care sessions. All subjects will always receive all their usual pain medications for all treatment conditions. The three conditions are: High Tech Virtual Reality (VRD), Low Tech Virtual Reality (Nature Slides), and standard wound care (no VR). The subjects will be randomly assigned to receive some portions of their wound care sessions during High Tech Virtual Reality (VRD), some portions during Low Tech Virtual Reality (Nature Slides), and some portions with standard wound care, no virtual reality. The treatment orders will be randomized. After each treatment condition the investigators will ask subjects one pain question about their pain intensity during the most recent treatment condition.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Compliant and able to complete questionnaires
* No history of psychiatric disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* English-speaking

Exclusion Criteria:

* Age less than 18 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Evidence of traumatic brain injury
* History of psychiatric disorder
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
* Unable to communicate orally
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history
A Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders

Objective: The study of medication adherence in depression (MAPDep study) aims to evaluate the effectiveness and cost-effectiveness of a multi-component strategy to enhance patient-centered care to improve adherence toward medications in patients with depression, formed by an educational intervention to psychiatrists and/or a collaborative care intervention group to patients and relatives plus a reminder system through the use of a mobile APP.

Methods: The objective will be assessed under an open multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care (control arm). In group 1 only patients and family members receive intervention, in group 2 only psychiatrists receive intervention, and group 3 is a combined intervention for patients and psychiatrists. The main measure will be the change in medication adherence rate. Secondary endpoints are depression, emotional distress, health-related quality of life, physical functioning, patients' knowledge about their medications, provider beliefs regarding patient-centeredness, and healthcare resource utilization.


Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * Patients with diagnosis of depressive disorder (major depressive disorder MDD and/or dysthymia) under pharmacological treatment
  * Regular users of mobile phones
  * Patients who have consulted their psychiatrist about their depression at least once in the previous 6 months
* Health professionals:

Psychiatrists have no intention of moving from their practice during the study period.

Exclusion criteria:

• Patient:

* Patients with history of current bipolar disorder and/or any psychotic disorder
* Insufficient language skills
* Pregnancy
Compaction Total Hip Arthroplasty (THA) Bilateral

This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side.

Hypothesis: Compaction results in significantly less stem migration \[evaluated by radiostereometric analysis (RSA)\], less peri-prosthetic bone mineral density (BMD) loss \[evaluated by dual energy x-ray absorptiometry (DEXA)\], and a higher Harris hip score after two years.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary arthritis in the hip
* Patients with sufficient bone density to allow uncemented implantation of a femoral component
* Informed patient consent in writing

Exclusion Criteria:

* Patients with neuromuscular or vascular disease in the affected leg
* Patients found upon operation to be unsuited for uncemented acetabulum component
* Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
* Patients with fracture sequelae
* Female patients of childbearing capacity
* Hip joint dysplasia
* Sequelae to previous hip joint disorder in childhood.
Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.

Cell mediated immunity is severely compromised after an allogeneic stem cell transplantation. This results in an increased risk of zoster with its associated morbidity and mortality. Patients typically receive prophylactic antivirals for 1 year after AlloSCT which reduces the incidence of zoster during this period. Unfortunately, after completing prophylaxis, patients continue to be at a significantly increased risk of zoster with an incidence rate of up to 29% at 3-years post transplant. The recombinant zoster vaccine provides immunogenicity and has shown clinical efficacy in preventing zoster in patients who have received an autologous transplant.

Furthermore, it has been shown to be safe in patients who had received an allogeneic transplant in a retrospective study although immunogenicity seemed to be decreased in this cohort. Due to the paucity of data in allogeneic recipients, we propose a prospective, non-randomized study to evaluate the immunogenicity and clinical efficacy of the recombinant zoster vaccine in recipients of allogeneic stem cell transplantation. As a secondary endpoint, we will compare our results to historical data of immunogenicity and clinical effectiveness of the vaccine in autologous transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* ≥ 12 months and ≤ 36 months post-AlloSCT
* Donor sources: matched related, matched unrelated, cord blood
* Any malignant hematological disease including acute leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and myeloproliferative disorders.
* Any conditioning regimen
* Any planned immunosuppressive prophylactic regimen
* Patients with chronic graft-versus-host disease on stable immunosuppression
* Ability to understand and the willingness to sign a written informed consent.
* Negative pregnancy test in female patients of childbearing potential

Exclusion Criteria:

* Patients who had zoster after an allogeneic transplant and prior to enrollment
* Patients who are currently pregnant
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the recombinant zoster vaccine, Shingrix, or other agents used in study.
* Patients who have had a relapse of their primary hematological disease
* Previous allogeneic stem cell transplantation
* Acute disease at the time of vaccination
* Thrombocytopenia that in the judgment of the investigator would make intramuscular injection unsafe.
Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds

Carbon dioxide infusion is a non surgical procedure applied via percutaneous, transdermal and subcutaneous. Increase in the concentration of carbon dioxide decreases pH activating local nitric oxide that stimulates collateral vessels formation, vascular endothelial growth factor and basic fibroblast growth factor. Carbon dioxide infusion restores the blood flow in chronic wounds of the lower limbs.

Ten patients with chronic wounds caused by venous insufficiency at both lower limbs were distributed into groups. Group I was composed by wounds in the right lower limb that received carbon dioxide and group II by wounds in the left lower limb that not received carbon dioxide, both related to the same patient. Carbon dioxide infusion was performed with the needle pointed toward the granulation tissue, 5cm distant from each one at intervals of 4 days. Biopsies were collected from the wounds before carbon dioxide infusion and after the 3rd, 5th and 10th application. Statistical analysis of the data was performed using Wilcoxon's test and Friedman's variance analysis and multiple comparisons test.

Eligibility Criteria:
Inclusion Criteria:

* chronic wounds caused by venous insufficiency

Exclusion Criteria:

* other diseases of the lower limbs
Optimising Protection for Pregnant Women and Infants With Maternal Vaccination

This study has been designed to investigate if:

1. BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy.
2. If pertussis vaccine co-administered with influenza vaccine impacts on the immunogenicity of the influenza vaccine.
3. If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.

A clinical observation study to determine whether obesity during pregnancy is associated with altered immunogenicity of influenza and pertussis vaccines during pregnancy. The study will also assess vaccine specific antibody concentrations in cord blood collected from vaccinated women at the time of delivery to estimate any effect of obesity on transplacental transfer of antibodies and will measure and compare cytokine profiles between obese and non-obese participants to determine any correlation with immune responses. This study will enrol 150 pregnant women (50 obese and 100 non-obese) during 2017-2019 to receive a recommended, licensed influenza vaccine (FluQuadri) as well as pertussis vaccination (Adacel) for women enrolled in their third trimester, as part of routine antenatal care. Local and systemic adverse events will be captured using a 7 day diary card and unexpected or serious adverse events will be recorded for the duration of the study. Blood samples will be collected to measure antigen specific vaccine antibody responses. The proportion of influenza vaccine recipients achieving seroprotective antibody titres at 4 weeks post vaccination and persisting at 6 months post vaccination be compared between obese and non-obese recipients.

Eligibility Criteria:
Inclusion Criteria:

* Participants who, in the opinion of the study staff, can and will comply with the requirements of the protocol (eg. return for follow-up visits, blood collection etc).
* Pregnant women aged 18 years and over at the time of vaccination.
* Able to understand the information sheet and provide a written informed consent.

Exclusion Criteria:

* Any major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study, or interfere with the evaluation of the study objectives.
* History of serious medical conditions (eg cardiac, respiratory, renal, hepatic disorders, diabetes requiring treatment with insulin).
* History of seasonal influenza or dTpa vaccination within the last 6 months prior to enrolment.
* History of any immunosuppressive condition or currently on immunosuppressive medication.
* Any contraindication to influenza or dTpa immunisation.
* Anaphylaxis following a previous dose of any influenza or pertussis containing vaccine.
* History of anaphylaxis to egg.
* Past history of Guillain Barre Syndrome.
* Bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw.
* Receipt of immunoglobulins, blood or blood products within the past 6 months.
Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study

This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.


Eligibility Criteria:
Inclusion Criteria:

* one-time ischemic stroke in the left hemisphere
* greater than 6-months post-stroke onset
* between 25 and 75 years of age
* aphasia diagnosis (as determined by pre-treatment language-based testing)
* right-handed (before the stroke)
* native speaker of English
* ability to provide informed written or verbal consent

Exclusion Criteria:

* clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
* factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
* prior history of epileptic or unprovoked seizures occurring during the previous 12 months.
* Presence of Metal implants of claustrophobia (not able to undergo MRI)
* Pregnancy
* Presence of any other neurological disease than stroke
* Childhood history of speech, language, hearing, or intellectual impairment