cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers

This Phase I, single-dose, randomized, parallel-group, open-label study will evaluate the safety, tolerability, and pharmacokinetics of MABT5102A following subcutaneous (SC) and intravenous (IV) administration in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria

* Male subjects aged 18-50 years and female subjects aged 18-50 years who are not of childbearing potential and who are in good general health at the screening visit
* Body weight between 50 and 100 kg
* For male subjects of reproductive potential, a reliable means of contraception must be used (e.g., abstinence or a condom) for the duration of the study

Exclusion Criteria

* Female subjects with reproductive potential.
* Subjects with evidence of clinically significant neurologic, psychiatric, hepatic, renal, hematologic, pulmonary, respiratory, immunologic system abnormalities, acute infection, or other unstable medical disease
* Subjects with any malignancy (with the exception of completely excised basal cell or squamous cell carcinoma of the skin)
* History of alcohol, drug, or substance abuse within 6 months prior to randomization that, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study
* Past history of seizures, with the exception of childhood febrile seizures
* Clinically significant laboratory or ECG abnormalities
* Hospitalization during the 4 weeks prior to screening
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

The study will capture post-marketing safety data on patients treated with eculizumab or ravulizumab. Additionally, the study will collect information on the progression of disease in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of any age, including minors, who have been diagnosed with aHUS
* Patients with or without an identified complement pathogenic variant or anti-complement factor antibody
* Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent \[if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)\].
* ADAMTS13 \> 5%, if performed.

Exclusion Criteria:

* Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC).
* Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees \[IRB/IEC\]).
Elective Neurectomy During Inguinal Hernia Repair

Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair.

It may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain.

This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms after Lichtenstein hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* Uni- or bilateral inguinal hernia
* Karnofsky-index ≥70
* Informed consent

Exclusion Criteria:

* Recurrent inguinal hernia
* Previous inguinal operation
* Emergent operation
* Severe comorbidities
Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.

Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate cancer
* Clinical Tumor Category T1b, T1c, T2a and PSA greater than (\>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity \> 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or \> 3+4=7 with 50% or more cores positive
* Negative bone scan
* Lymph node assessment by CT or MR
* Adequate hematologic function (Blood Counts)
* Adequate liver functions (blood tests)
* ECOG performance Status 0 or 1
* Peripheral neuropathy must be =\< grade 1
* PSA obtained within 3 months of entry

Exclusion Criteria:

* Prior history of malignancy that are \< 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management.
* Prior pelvic radiation therapy
* Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)
* Individuals unable to tolerate lying still 5 - 10 minutes
* Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.
The Impact of the Glycaemic Index (GI) on Daily Blood Glucose Profiles and Food Intake in Young Chinese Adult Males

This study is carried out to find out the inclusion of high and low glycaemic Index (GI) foods to daily meals impact on 24 hour blood glucose fluctuations and food intake.

The GI is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as they have a lower impact on blood glucose concentrations and also reduce total food intake. There is very little information on how eating high and low GI foods affect daily blood glucose concentrations in Asians. Therefore, the objective of this study is to observe the effect of eating high and low GI breakfasts and snacks on 24 hour blood glucose concentrations and food consumption in Asian males. Healthy, normal-weight, Chinese males will be recruited. There will be two sessions (consisting of four days for each session) where they will consume either a high or low GI breakfast or snack, and a standardized ad libitum lunch buffet. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period. The proposed research for the first time demonstrates how the consumption of high and low GI breakfasts and snacks affect subsequent energy intake and 24 hour blood glucose profiles in Asians. These findings will have significant public health benefits for optimum weight and dietary control.

Eligibility Criteria:
Inclusion Criteria:

* Chinese, male
* Age between 21-40 years
* Body mass index between 17 to 24 kg/m2
* Normal blood pressure (120/80 Hgmm)
* Fasting blood glucose \< 6 mmol/L

Exclusion Criteria:

* Having any metabolic diseases (such as diabetes, hypertension etc)
* One prescription medication
* Partaking in sports at the competitive and/or endurance levels
* Allergic/intolerant to any of the test foods
* Intentionally restricting food intake
* Smoking
Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain

This study evaluates cognitive dysfunction status and related factors in patients with chronic low back pain over the age of 60.

The study was designed as prospective, cross-sectional and hospital-based. 55 consecutive patients over the age of 60, diagnosed with CBP, who have been suffering from low back pain for at least 6 months, and a similar number of healthy volunteers (control) in terms of age and gender, who applied to the Physical Medicine and Rehabilitation outpatient clinic of Konya Beyhekim Training and Research Hospital, will be included in the study. Patients will be included in this cross-sectional, survey-type research after their compliance with the inclusion criteria is meticulously determined as a result of anamnesis and physical examination.

Detailed histories of all participants will be taken and detailed physical examinations will be performed. Sociodemographic and clinical characteristics of the participants, such as age, gender, height, weight, educational status, marriage status, duration of illness, and employment status, will be recorded.

Patients will be asked some survey-type questions in a decent environment. Patients' pain and fatigue levels were measured by the visual pain scale (VAS), their emotional states by the Beck depression scale (BDI) and Pain catastrophizing scale, their functional disability level by the Roland Morris Disability Questionnaire, and their sleep quality by the single Likert type question in the Pittsburgh questionnaire. Quality of life will be evaluated with Short Form-36 (SF-36), and their cognitive status will be evaluated with Standard Mini mental test (SMMT) and Montreal cognitive assessment scale (MOCA).MOCA, mini mental test and mood tests are administered by a professional psychologist experienced in the application of these scales.

Eligibility Criteria:
Inclusion Criteria:

Being over 60 years old Having a history of low back pain lasting more than 6 months and being diagnosed with CBP Having pain of at least 3 intensity according to VAS

Exclusion Criteria:

Those under 60 years of age

* Those with neurological deficits
* Those with inflammatory low back pain
* Those with rheumatic diseases such as fibromyalgia, polymyalgia rheumatica, ankylosing spondylitis, rheumatoid arthritis
* Having undergone surgery in the lumbar region within the last 6 months
* Those with widespread pain, those with significant pain in another anatomical location (e.g. gonarthrosis)
* Those who use drugs or substances (alcohol, drugs, etc.) that may cause cognitive impairment
* Those with known neurological diseases such as cerebrovascular disease, MS, Parkinson's, dementia
* Those with major psychiatric illness
* Those with communication problems
* Those who have started psychiatric medical treatment within the last three months
* Those with significant hearing or vision problems
* Those with a history of uncontrolled systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological, endocrine, etc.)
Impact of Predictive Genetic Testing

Analysing Impact of preemptive genetic testing on quality of life, physical activity and eating behavior at baseline and 3 months after testing.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* informed consent for genetic testing
* informed consent for study participation

Exclusion Criteria:

* Age \<18 years
* renal replacement dependency
* pregnancy
* active cancer disease
* no informed consent for genetic testing or study participation
Personalized Health Planning in Shared Medical Appointments for Individuals With Type II Diabetes Pilot Study

The primary aim of this study is to examine the feasibility of implementing an evidence based patient engagement strategy, known as personalized health planning (PHP), in the context of a a shared medical appointment (SMA) for individuals with type II diabetes in a primary care setting.

All data for the prospective portion of this study was done being collected in September 2016. The retrospective chart review will collect data up until March of 2017 (six months after the last subject completed the prospective phase by attending their last SMA session).

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Type 2 diabetes within the last year
* A current patient at Duke Family Medicine.
* An A1C score greater than 7 and less than 14.

Exclusion Criteria:

* A diagnosis of Pre-diabetes
* A diagnosis of Type I diabetes
* Individuals with amputations as a result of their diabetes are excluded form this study.
* Individuals with renal dialysis will not be included in this study.
Discharge Counseling and Medication Therapy Management (MTM) Services After Discharge for Heart Failure Patients

Readmission to a hospital shortly after discharge is a common and costly problem. In the United States patients with a diagnosis of heart failure currently experience an elevated 30 day readmission rate of approximately 20%. By providing patients with medication related counseling at discharge by a pharmacist, home medications at discharge, and seeing the patient again in a pharmacist-run Medication Therapy Management (MTM) clinic 7 days after discharge, the study anticipates achieving its primary goal of showing a reduction in the readmission rate. Secondary goals are: 1) to determine patients understanding of the medication they are taking, 2) to evaluate satisfaction with the comprehensive discharge counseling service, and 3) determine the number of interventions made and benefit of the MTM clinic.

The active arm of this study (medication related hospital discharge counseling by a pharmacist, home medications, and 7 day follow-up visit at a pharmacist run MTM clinic) is available to all subjects. To study the primary goal of reducing the 30 day readmission rate the data obtained from the active arm subjects will be compared to a match group of hospitalized patients that were previously discharged with a diagnosis of heart failure. The data for all secondary study goals will be obtained directly from the active arm subjects.

Eligibility Criteria:
Inclusion Criteria:

* Heart Failure with high risk for readmission.
* Enroll in study prior to hospital discharge.

Exclusion Criteria:

-
Study of the Effect of Exercise Training on Patients in Atrial Fibrillation

PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (AF). The investigators studied the effect of physical exercise on cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of physical exercise training three times weekly for twelve weeks.

HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF.

METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and muscular strength was performed before and after 12 weeks.

Resting echocardiography was done at baseline. CO was measured using impedance cardiography at rest and during maximal exercise testing on an ergometer bicycle. Body composition, muscular strength and six minutes walking capacity were measured before and after the training period. Qol was evaluated by the use of the standardized validated questionnaires Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).

Training consisted of aerobic exercise at 70 percent of max. capacity estimated by Borg-scale.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study.

Exclusion Criteria:

* Subjects with severe refractory hypertension
* previous heart valve surgery, moderate to severe COPD
* restrictive lung disease, moderate to severe asthma
* pregnant or lactating subjects
* patients with a very low life expectancy
* patients who were unable to exercise or comply with the study protocol
A Randomized Clinical Trial of the Effect of Pimecrolimus Cream 1% Compared With Topical Corticosteroid in Treatment of Erosive Oral Lichen Planus

The purpose of this study is to compare the effect of topical Pimecrolimus with adcortyl on erosive-atrophic 0ral lichen planus in a randomized clinical trial study.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed oral lichen planus in combination with a compatible clinical appearance was used for diagnosis.

Exclusion Criteria:

* Unable to undergo oral biopsy for diagnosis
* Systemic diseases or malignancy
* Pregnancy
* Lesion/lesions with dysplasia/ history of allergic reaction to corticosteroids or immunomodulatory drugs.
* Lesions adjacent to amalgam filling were also excluded from this study.
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.

The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment
* Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization
* Adequate organ function
* Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)

Exclusion Criteria:

* Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer \> 5 years prior to initial diagnosis of GEA
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy for unresectable locally advanced, recurrent or metastatic GEA
* Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are completely off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)
* Known history of or ongoing leptomeningeal disease (LMD)
* Known additional malignancy that is not considered cured or that has required treatment within the past 3 years
* Known active hepatitis
* Any history of human immunodeficiency virus (HIV) infection
* Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligible
* QTc Fridericia (QTcF) \> 470 ms
* Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF)
Digital Health Navigation for Latino Patients With Type II Diabetes

The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge.

Latinos have the second-highest age-adjusted prevalence and among the highest incidence of diabetes. Latinos also experience worse glycemic control and diabetes-related complications, including diabetic retinopathy and chronic renal disease. These findings are concerning since Latinos are the largest minority group in the U.S and will account for 25% of the population by 2045.

Digital tools, like patient portals and telemedicine, offer an opportunity to address some of the challenges that lead to these disparities, especially during care transitions. However, Latinos, especially those who are Spanish-speaking are less likely to use digital health tools. Findings from previous health information technology work have highlighted barriers, including 1) digital access and literacy, 2) interface usability, 3) privacy, and 4) patient preference. One promising intervention to address digital literacy gaps is the use digital navigators.

This study aims are to assess a digital health navigation intervention focused on increasing patient portal use after discharge among Latino patients with type II diabetes admitted to the general medicine inpatient floor.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified Latino adult patients with type II diabetes
* Admitted to general medicine floors at Brigham and Women's Hospital
* Preferred language: English or Spanish

Exclusion Criteria:

* Critical illness
* dementia, delirium, or other condition that limits ability to participate in education and consent process
Neurotomy of Optic Nerve in Non-Arthritic Anterior Ischemic Optic Neuropathy

Non-arthritic anterior ischemic optic neuropathy is the most common cause of sudden visual loss due to optic nerve involvement in patients above 50 years old. As this problem can be considered as a sclera out let syndrome an there is no effective and successful treatment for it, we decided to do a neurotomy procedure and relax the involved optic nerve in order to achieve acceptable treating outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-arthritic anterior ischemic optic nerve

Exclusion Criteria:

* Visual acuity more than 20/200
* Other intra occular operations
* Passing more than 4 weeks of the problem
* Arthritic anterior ischemic optic nerve
* Age under 50 years
* Consumption of previous pharmaceutical treatment
Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway

Respiratory failure is the most frequent organ failure and cause for admission in the Intensive Care Unit (ICU) . It is a severe complication with an ICU mortality ranged from 31% to 33%. Symptomatic treatment of hypoxemic respiratory failure is a controversial topic with different options: 1) standard oxygen therapy, 2) high flow nasal cannula oxygen therapy (HFNC) and 3) non-invasive ventilation (NIV).

The aim of the study is to compare HFNC versus NIV ventilation using CT scan. The hypothesis of this study is that in hypoxemic critically ill patients, the increase of lung volumes with NIV would be significantly higher than the increase of lung volumes with HFNC.


Eligibility Criteria:
Inclusion Criteria:

* Patient with hypoxemia at any time of ICU stay defined as follow: standard oxygen therapy flow ≥ 3L/min to maintain a pulsed oxygen saturation ≥ 95%
* Adult (age ≥ 18 years)
* (2) A CT scan prescribed by the physician in charge of the patient as part of the exploration of the patient's pathology and not as part of a "dedicated" prescription for the study.

Exclusion Criteria:

* NIV contraindication (need for immediate endotracheal intubation and mechanical ventilation; hemodynamic instability defined by systolic blood pressure \< 90 mmHg or mean blood pressure \< 65 mmHg, use of vasopressors; Glasgow Coma Scale score of 12 points or less)
* History of recent facial trauma not compatible with the use of nasal cannulas
* Pregnancy
* Refusal of study participation
* protected person
* Patient not affiliated to the social security system or not benefiting from such a system
* Lack of signed informed consent