cyrilzakka/clinical-trials huggingface dataset:
Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518)

This is an observational prospective follow-up study to assess the utilization of boceprevir and the management of pre-specified health outcomes of interest (HOIs) under conditions of routine clinical care in participants with chronic hepatitis C (CHC) genotype 1.

As an observational prospective study, this study is not intended to change the participant/physician relationship, nor influence the physician's drug prescription or therapeutic management of the participant. No individual administration of any therapeutic or prophylactic agent is assigned in this protocol, and there are no procedures required as part of this protocol. Physician choice of the drug used to treat the participant is based on clinical judgment alone.


Eligibility Criteria:
Inclusion Criteria:

* Documented chronic hepatitis C (CHC) genotype-1 infection
* Untreated or failed previous therapy
* Initiated a new treatment regimen after the study implementation date at their site
* Agrees to participate in the study by giving written informed consent

Exclusion Criteria:

* Taking part in a clinical trial or in any study where a participant is receiving care outside of normal clinical practice for Hepatitis C Virus (HCV)
Motor Training and White Matter in Multiple Sclerosis (MS)

In the current study the researchers will firstly investigate whether a bimanual coordination training protocol (20 min/day, for 8 consecutive weeks) correlates with changes in white matter architecture and improved upper-limb functionality in patients with multiple sclerosis. Secondly, the researchers predict that motor learning is more efficient when it is combined with anodal transcranial direct current (tDCS) stimulation on the left primary motor cortex.


Eligibility Criteria:
Inclusion Criteria:

* Expanded Disability Status Scale (EDSS) scores between 2 and 6.5
* Stable MS (no relapse during the last 3 months before study onset)
* age: between 18 and 68 years

Exclusion Criteria:

* Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication.
* Standard TMS/tDCS and MRI exclusion criteria (safety questionnaires)
Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

Main purpose of the study is to evaluate the effect of sevoflurane on intra cranial pressure (ICP) after traumatic brain injury. Patients admitted for traumatic brain injury equipped with ICP measurement will be sedated with sevoflurane via the Anaconda device during 12 hours. Sedation will be controlled with BIS.

Sedation is most of the time required for ICP management after traumatic brain injury. Sevoflurane, an inhaled anaesthetic drug is commonly used in operatory room. Thanks to a new device, the Anaconda, it now can be applied to intensive care patients. His advantages a rapid elimination after administration stops, which can allow an early neurologic evaluation, very important for traumatic brain injury patients.We will study the effect of sevoflurane administration on ICP of TBI patients. Patients admitted for severe TBI (Glasgow come scale \< 8), equipped with ICP sensor, elder than 18 years old will be include. A sedation with sevoflurane will be administrated during 12 hours instead of classical intra venous sedation with midazolam, depending on BIS score. ICP evolution will be characterised in success if \< 30 mmHg or failure if ≥ 30 mmHg.6 patients will be included for the first phase. The study will be stopped if the failures are ≥ 2. Otherwise, 27 patients will be included. Study will be stopped if failures number ≥ 5 before the end if the inclusion period.

Eligibility Criteria:
Inclusion Criteria:

* severe traumatic brain injury (glasgow \< 8)
* age \> 18
* no surgery scheduled
* sedation with midazolam and sufentanil
* ICP sensor

Exclusion Criteria:

* external ventricular derivation
* pregnancy
* antecedent of malign hyperthermia
* haemodynamic instability
Deep Learning of Retinal Photographs and Atherosclerotic Cardiovascular Disease

The research team has developed a deep learning algorithm that predicts anthropometric factors from fundus photographs and an algorithm that predicts cardiovascular disease risk. Fundus photographs are taken for various cardiovascular diseases (myocardial infarction, heart failure, hypertension with target organ damage, high-risk dyslipidemia, diabetic patients, and low-risk hypertension patients), and a deep learning algorithm for predicting developed anthropometric factors will be validated. Fundus photographs will also be taken twice in the first year, and additional fundus photographs will be taken two years later. Major cardiovascular events will be followed up for 5 years to verify the deep learning algorithm predicting cardiovascular disease risk prospectively.


Eligibility Criteria:
Inclusion Criteria:

1. Myocardial infarction (Patients diagnosed with myocardial infarction within 5 years and confirmed significant coronary artery stenosis by cardiovascular angiography)
2. Heart failure with reduced EF (\<40% of LVEF on echocardiography or magnetic resonance imaging)
3. Heart failure with preserved EF (≥40% of LVEF on echocardiography and NT-proBNP ≥200 pg/mL and LAVI ≥ 34 ml/m2 or LVMI ≥115 g/m2 (men) or LVMI ≥95 g/m2 (women))
4. High risk subclinical atherosclerosis (no symptom and ≥50% stenosis of coronary artery on coronary angio CT or asymptomatic PAOD or cerebral aneurysm or ≥50% stenosis of cerebral artery or ABI \<0.9 or ≥2mm of atherosclerotic plaque or hypoechogenic plaque on carotid ultrasound)
5. Hypertension with target organ damage (proteinuria \[urine albumin/creatinine ratio ≥ 30 mg/g or protein/creatinine ratio ≥ 150 mg/g or 24 hour urine albumin ≥30mg/day or 24 hour urine protein ≥ 150mg/day\] or LV hypertrophy \[on EKG or echocardiography\] or cfPWV \> 10 m/sec or baPWV \> 1800 cm/sec or eGFR \< 60 ml/min/1.72 m2 or atherosclerotic cardiovascular disease or white matter hyperintensity on brain MRI)
6. High risk dyslipidemia (LDL-cholesterol \>190 mg/dL or \> 160 mg/dL inspire of use of moderate or high intensity statin)
7. Diabetes (Type 2 diabetes with more than 5 years of diagnosis or type 1 diabetes with more than 10 years of diagnosis)
8. Low risk (Hypertension that does not meet the above criteria and is controlled by 3 drugs or less 2) Dyslipidemia that does not meet the above criteria and is controlled below the target LDL)

Exclusion Criteria:

1. Serious eye diseases that make it impossible to take adequate quality fundus photography
2. If the subject cannot read and sign the consent form in person
Intensive Management for Gestational Diabetes

This is a randomized clinical pilot trial designed to assess the feasibility of randomizing obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration will also be compared between groups.

The investigators will randomize 60 obese pregnant women with a new diagnosis of gestational diabetes using the Carpenter-Coustan criteria in a 1:1 fashion to either standard care or intensive therapy. Subjects will be randomized to either standard care or intensive therapy at the first study visit, which will occur between 12-32 weeks of gestation after they have completed their gestational diabetes testing. Neither patients nor their providers will be blinded to patient study group. All women will receive standard nutritional counseling at the time of diagnosis, and they will also be treated with either glyburide or insulin as dictated by standard care. Women will return for a second study visit between 32-36 weeks of gestation to assess the impact of their glycemic target groups on overall glycemic control. The investigators will also collect information on the type and dose of each medication required to maintain glycemic control in women randomized to either standard care or intensive therapy.

In addition to standard glucose monitoring 4x/day (fasting and one-hour post breakfast, lunch, and dinner), the investigators will utilize blinded continuous glucose monitors (iPro, Medtronic) at each study visit. Because women with GDM are receiving active management of their blood sugars and dietary counseling, the investigators will assess CGM for 5 consecutive days both at study enrollment and again between 32-36 weeks. Study participants will complete food diaries during their CGM monitoring to correlate food intake with glycemic variation. The investigators will also compare maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration between groups.

Eligibility Criteria:
Inclusion Criteria:

* maternal age between 18-45 years
* singleton birth
* planned delivery at OU Medical Center
* GDM diagnosed between 12-32 weeks' gestation by either a 50 gram
* one hour GCT \>200 mg/dL or two or more abnormal values on a 100 gram OGTT using the Carpenter-Coustan criteria
* pre-pregnancy BMI ≥26 kg/m2.

Exclusion Criteria:

* maternal tobacco use
* planned delivery prior to 34 weeks of gestation
* significant fetal anomalies
* chronic hypertension requiring medication
* other vascular disease
* known renal disease with a baseline serum creatinine \>1.5 mg/dL
* maternal rheumatologic disorders requiring medication
* maternal human immunodeficiency virus (HIV) or hepatitis
* as the specimen storage facility is not accredited to handle such samples
* steroid use within 7 days.
Effect of S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine

The purpose of this study is to investigate whether S-adenosylmethionine (SAMe), a natural substance available as a nutritional supplement, can influence blood levels of homocysteine (Hcy). More specifically, we will determine if chronic oral SAMe administration affects homocysteine metabolism in patients with vascular disease who have mild to moderate hyperhomocysteinemia.

The purpose of this study is to investigate whether S-adenosylmethionine (SAMe), a natural substance available as a nutritional supplement, can influence blood levels of homocysteine (Hcy). More specifically, we will determine if chronic oral SAMe administration effects homocysteine metabolism in patients with vascular disease who have mild to moderate hyperhomocysteinemia through the following specific aims:

Specific Aim 1 - To determine the effect of oral SAMe (1200 mg/day) on plasma total homocysteine levels in subjects with mild to moderate hyperhomocysteinemia.

Specific Aim 2 - To determine the effect of oral SAMe (1200 mg/day) with and without supplementation of folate, vitamin B12 and B6, on plasma homocysteine levels in patients with mild to moderate hyperhomocysteinemia.

Specific Aim 3 - To determine the effect of oral SAMe (1200 mg/day) on plasma levels pf asymmetric dimethylarginine (ADMA) in subjects with mild to moderate hyperhomocysteinemia.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Must have a serum homocysteine value greater than or equal to 14 μmol/L
* Stable weight 3 months prior to study participation

Exclusion Criteria:

* Subjects with a BMI greater than 35 or less than 18
* Currently taking B 100 or other high-dose B vitamin supplements within the past 12 months
* Taken methionine or SAMe supplements within the past 3 months
Study in Patients with Relapsed/refractory Primary Mediastinal Lymphoma Treated with Pembrolizumab or Nivolumab in Combination with Brentuximab Vedotin in a Real-life Context

Observational, Non-Interventional, Retrospective, Multicenter Study Focusing on the Efficacy and Safety of Pembrolizumab Monotherapy and Nivolumab in Combination With Brentuximab Vedotin in Clinical Practice Patients With Primary Mediastinal B Cell Lymphoma Relapsed/Refractory

Observational, non-interventional, retrospective, multicentre study focusing on the efficacy and safety of pembrolizumab as monotherapy and nivolumab in combination with brentuximab vedotin in daily clinical practice in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory. The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, sum of complete response rate \[CR\] and partial response rate \[PR\]) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/RefractoryL treated in a real-life setting from November 2020 until November 2021.

Secondary objectives

* To assess efficacy, in terms of:
* Duration of response (DoR)
* Progression-free survival (PFS)
* Overall survival (OS)
* Disease-free survival (DFS)
* Best response rate (achieved at any time during treatment)
* To evaluate the safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin The study will include patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life setting from November 2020 until November 2021.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021
2. Age ≥ 18 years at enrollment
3. Signature of written informed consent (where applicable)

Exclusion Criteria:

1. Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a clinical trial context.
Prevention and Rehabilitation of Stroke in Uganda

Stroke is increasing in low-income countries in Africa, and knowledge is lacking on risk factors and how to prevent stroke as well as how to best use the resources for rehabilitation after stroke which are very limited. Knowledge generation within this area is therefore urgently needed. This collaboration between the research group HELD (Health and Everyday Life among people with neurological Disorders), Karolinska Institutet (KI) and the research surveillant site Africa Medical and Behavioral Sciences Organization (AMBSO) population health surveillance (PHS), will create substantial research opportunities to develop and improve prevention and rehabilitation for stroke, which is in line with the sustainable development goals to reduce the prevalence and mortality rates due to NCDs. AMBSO is collecting data from 17 000 households on many potential risk factors for stroke. Questions about stroke primary and secondary prevention of stroke and impact of stroke or need of rehabilitation could be added to the existing questionnaires such as the validated Ugandan version of the Stroke Impact Scale. This is intended to fulfill the aim of the network which is to increase the knowledge of occurrence and consequences of NCDs with a specific focus on stroke, which will be valuable for the development of preventive healthcare policy documents and guidelines for appropriate prevention strategies and rehabilitation interventions.

Research questions in relation to NCDs with focus on stroke prevention and rehabilitation:

* How many cases (prevalence) are reported in the targeted study sites and what is the mortality rate (incidence) that can specifically relate to stroke?
* How does stroke and other NCDs affect and impact the quality of life for persons living in Uganda?
* Which factors impact the recovery process after stroke?
* What sort of rehabilitation is needed in the study areas for persons affected by stroke? In addition, risk factors of stroke such as diabetes and hypertension will be mapped.


Eligibility Criteria:
Inclusion Criteria:

* Stroke
* Risk factors for stroke: hypertension, diabetes, HIV, malaria, physical inactivity, obesity

Exclusion Criteria:

* Not having had stroke and/or having no risk factor for stroke
Preoperative Pain and POCD in Elderly Patients

The purpose of this study is to investigate whether preoperative pain is the risk factor of POCD in elder patients.

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. The mechanism of POCD is not clear yet and no effective therapy method. In the present study, we conducted a single-center observational prospective cohort trial in elder patients who undergoing hip joint replacement surgery with general anesthesia to test our hypothesis that preoperative chronic pain is one of the risk factors of POCD after major joint replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Elder than 65 years old
2. Speak Chinese Mandarin
3. Those who will undergo major low limb surgery like hemiarthroplasty or total hip arthroplasty with general anesthesia.
4. Signed the inform consent
5. American Society of Anesthesiologists classification I to II

Exclusion Criteria:

1. Existing cerebral disease, or have a history of neurological and psychiatric disease including Alzheimer Disease, stroke, epilepsy and psychosis
2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
3. Severe hearing or visual impairment
4. Unwillingness to comply with the protocol or procedures
5. Cannot communicate with Chinese Mandarin
6. Serious pulmonary, heart , liver or renal insufficiency patients
7. Had anesthesia or surgery within the past 30 days
The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients

The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.
Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients at least 12 years of age
* Male and female; female subjects of childbearing potential must be willing to use birth control
* Pre-bronchodilator FEV1 of 40-90% predicted normal
* Reversibility FEV1 of at least 12% and 200mL
* Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit

Exclusion Criteria:

* History of life-threatening asthma during last 10 years
* Respiratory infection or oral candidiasis
* Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment
* Uncontrolled disease or clinical abnormality
* Allergies to study drugs or the excipients
* Taking another investigational medication or prohibited medication
* Night shift workers
* Current smokers or subjects with a smoking history of at least 10 pack years
e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English

This research is being done to learn more about whether or not Korean American women will improve the screening practices for breast and cervical cancer if subjects receive education and follow-up from community health workers. The education materials may be given via online or in-person. Primary Hypothesis: e-CHEC-uP will be as efficacious as the original CHEC-uP in promoting mammogram and Pap test screening among Korean immigrant women (KIW) at 6 months.

Objectives: (1) To develop a web-based platform of the health literacy education component of the original CHEC-uP intervention; (2) To evaluate the acceptability and usability of the web version of the health literacy education in a user testing sample of 10 KIW; and (3) To conduct a pilot study to test the preliminary efficacy of the web version of CHEC-uP (e-CHEC-uP) in 40 KIW.

e-CHEC-uP stands for e-Community based breast and cervical cancer control education program.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-65 years
* Self-identified as a Korean American woman
* Overdue for a mammogram (40-65 years of age only) or a Pap test\*\*
* Able to read and write Korean or English
* Willing to provide written consent to allow the researchers to audit medical records for mammography and Pap test use

Exclusion Criteria:

* A cancer diagnosis
* Being pregnant
* An acute and/or terminal condition (e.g., life expectancy of less than 6 months or last cancer treatment within the last 5 years)
* Psychiatric diagnosis (e.g., schizophrenia or cognitive impairment) or other conditions that preclude participation in the study activities
* Had undergone a hysterectomy