cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Body Weight and Glycohemoglobin

Control of body weight (BW) is important to prevent and manage type 2 diabetes. Regardless of the close association, little is understood about the precise relationship between BW and glycemic control, which might be of benefit for patients with type 2 diabetes. The researchers investigated the correlation between changes in BW and glycemic control in patients with type 2 diabetes treated with a diet therapy or pioglitazone.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes under reasonable glycemic control (HbA1c; less than around 7%)
* type 2 diabetic patients treated with the diet therapy

Exclusion Criteria:

* type 2 diabetic patients with edema, severe liver dysfunction, renal dysfunction, moderate to severe anemia or congestive heart failure
* type 2 diabetic patients treated with insulin therapy
Efficacy of Vitamin D3 for the Treatment of Psoriatic Patients With Vitamin D Deficiency and Insufficiency

The purpose of this research is to study whether vitamin D supplement can improve clinical outcome (PASI score) in psoriasis vulgaris with vitamin D insufficiency and deficiency.

While psoriasis is not a lethal disease, the disease itself can impact patients' quality of life. Nowadays there are several researches on vitamin D functions. Recently review article of vitamin D deficiency by Holick MF., stated that vitamin D can play a role in decreasing the risk of osteoporosis and other chronic diseases such as malignancy, autoimmune disease, infectious disease, cardiovascular disease, and psoriasis. Moreover, vitamin D effects on keratinocyte by decreasing abnormal cell proliferation, differentiation, apoptosis and controlling immunological process via the suppression of T-cell activation, regulation of cytokine secretion patterns, induction of regulatory T-cell, modulation of T-cell proliferation and interference with T-cell apoptosis.

Thus, our objective is to look for other alternative treatment, which may have less side effects and acceptable clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderately severe (PASI ≤ 10), chronic plaque type psoriasis vulgaris patient, who is a new case or has at least treatment-free period as following: 4 weeks for topical calcipotriol, topical corticosteroid or 8 weeks for systemic therapy (i.e. cyclosporine, acitretin, methotrexate) or 12 weeks for Psoralen Ultraviolet A (PUVA), phototherapy or biological treatment.
* Age 18-year-old to 70-year-old.
* Psoriasis vulgaris patient with vitamin D insufficiency or deficiency.

Exclusion Criteria:

* Pregnancy or Lactating mother.
* Subject with history of major gastrointestinal surgery or gastric bypass surgery.
* Subject with history of pustular psoriasis.
* Subject with active psoriatic arthritis.
* Subject with prior phototherapy within the past 3 months.
* Subject with history of hypocholesterolemia (serum cholesterol \< 120 mg/dl) or primary hyperparathyroidism.
* Subject who regularly takes vitamin D supplement exceed 3,000 iu/day and high vitamin D diet, for example cod liver oil.
* Subject with liver disease, cystic fibrosis, Crohn's disease, celiac sprue, renal disease, pancreatic disease, and inflammatory bowel disease.
* Subject taking following medication: corticosteroid, orlistat, rifampicin, isoniazid, ketoconazole, statin, and cholestyramine.
The Plenaxis® Experience Study

Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated population of patients receiving Plenaxis®. The purpose of the study is to estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis® and to determine whether the hazard rate changes over time.

This is a postmarketing patient safety study in the FDA indicated population of patients receiving Plenaxis®. On a quarterly basis, patients enrolled in the Plenaxis® Experience Study will have their charts audited to record the number of immediate-onset systemic allergic reactions that may occur while receiving Plenaxis®. The study will close when 2,000 patients have been enrolled. If immediate onset allergic reactions occur, patients may be eligible to enroll in a second protocol (skin testing in patients who experience an immediate onset allergic reaction). Collection of all immediate-onset systemic allergic reactions will continue for each patient enrolled in the study until the patient discontinues Plenaxis® for any reason, the patient withdraws consent to continue in the study or the patient is lost to follow-up.

Eligibility Criteria:
Inclusion Criteria:

A subject is eligible to participate in the study if he meets the following criteria:

* Male ≥ 18 years old with advanced symptomatic prostate cancer for whom LHRH agonist therapy is not appropriate and who refuses surgical castration
* Has at least one of the following:

  1. Risk of neurological compromise due to metastases,
  2. Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or
  3. Severe bone pain from skeletal metastases persisting on narcotic analgesia
* Patients or their legal representatives must be able to read, understand and sign an informed consent form to participate in the trial.

Exclusion Criteria:

* Female Patients,
* Pediatric patients,
* Patients with known hypersensitivity to any of the components in the abarelix injectable suspension
Research Tissue Bank

This study that will allow for the preservation and/or storage of a small portion one or more of the following tissues:

* Peripheral blood
* Bone marrow
* Bone marrow biopsy
* A phlebotomized unit of blood
* Spleen cells
* Toenail clippings

This material will be used for the study of Myeloproliferative Disorders (MPD) by researchers. The goals of this research study are to understand the causes of MPDs, how to diagnose them more easily and how to treat them better. MPD is a disease affecting hematopoietic stem cells. Hematopoietic stem cells are cells that make blood cells. These stem cells grow in the center portion of the bones called bone marrow. Under some conditions, these cells are also found in blood. There are several diseases, which are classified as MPD. These include polycythemia vera (too many red blood cells), essential thrombocythemia (too many platelets), and idiopathic myelofibrosis (abnormal blood cells and fibers build up in the bone marrow). These syndromes carry a high risk of developing leukemia. It is important to continue to learn more about these blood cancers and to learn more about the effectiveness and potential side effects of various treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Philadelphia chromosome negative myeloproliferative disorders (MPD) polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) are eligible.
* Newly diagnose MPD patients as well as previously treated for a MPD are eligible.
* Signed informed consent is required from each patient at the time of enrollment.

Exclusion Criteria:

* Patients currently participating in experimental treatment arms of MPD-RC protocols, or other experimental treatment protocols are not eligible during the period they are on study.
Development of Gourmet Medical Cooking Workshop for Lifestyle Changing and Its Affect on Perimenopausal Women

Subjects that participate in the practical workshop will improve their metabolic indexes, decrease their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions

Participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop. The workshop will consist of 9 lessons with the following lessons: introduction, fats, phytoestrogens, carbohydrates and fibers, calcium and low calorie diet, party's recipes, shopping and farewell dinner. All the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours "hands on" session under supervision of a medical chef. The study population will include healthy women attending the menopause clinic. 72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only. During 2008 the control group will commence the workshop and will add to the study group.

Eligibility Criteria:
Inclusion Criteria:

* Age of 45-60
* Perimenopause
* Healthy
* BMI over 17
Build a Research Clinic for Somatoform Patients

To investigate the effects of the two following interventions on somatoform patients:1. case management model2. psychotherapy, based on cognitive-behavioral therapy and biofeedback therapy

Patients with presentations of somatic symptoms and associated psychological features are named as "somatoform disorders" in psychiatric field. Because the patients' concerns are somatic distress, they often seek help in non-psychiatric clinics. However, the symptoms are usually medically unexplained. This group of diagnoses can be managed from the psychiatric perspective, including medications and psychotherapies. However, many patients do not receive psychiatric management in current medical practice. The goal of this project is to establish an association named "psychosomatic center" for providing comprehensive evaluations and treatments to the somatoform patients. Besides the psychiatrist, a case manager, a clinical psychologist, and a research assistant will be included in this association for the purposes of connection, performing psychotherapy and examinations. After entering the psychosomatic clinic, the investigators will routinely perform diagnostic interview, measure psychological and physiological features, and arrange individualized treatment program. The investigators will follow the important psychological and biological indexes every 3-6 months for building a cohort. At the same time, the case manager will connect with non-psychiatric clinics for ensuring the patients physical problems to be managed. The investigators expect this project to enhance the quality of treatment on the patients, to reduce the excessive examinations for the frequent attenders, and to improve the emotional burden of medical staffs.

Eligibility Criteria:
Inclusion Criteria:

* 1. Between 15 and 80 years old
* 2. Meet the diagnosis of DSM-5 somatic symptom disorder

Exclusion Criteria:

* 1. With psychotic symptoms (such as schizophrenia, bipolar disorder with psychotic symptoms) or cognitive impairment
* 2. Having potentially lethal physical diseases (such as cancer, coronary artery diseases, cerebrovascular diseases; because under this condition, high health anxiety is quite rational. Patients with common physical diseases can still enter this trial)
* 3. Unable to read or understand the questionnaires
Contingency Management Using Smartphone App in Patients With SUD

The purpose of this research study is to test the acceptance and efficacy of a smartphone app (DynamiCare Rewards) for patients with substance use disorder (SUD) who are in active treatment and recovery at BrightView.

The purpose of this research study was to test the acceptance and efficacy of a smartphone app (DynamiCare Rewards) for patients with substance use disorder (SUD) who are in active treatment and recovery at BrightView (www.brightviewhealth.com). Patients performed self-tracking of their recovery behavior (e.g., counseling attendance, abstinence from drugs and alcohol) addiction recovery behavior using the DynamiCare app, which follows Contingency Management (CM) model of incentivizing positive behavior.

CM is shown as a highly effective, evidence-based methodology for improving substance use disorder (SUD) outcomes. It does so by activating the brain's reward and inhibitory systems through both positive and negative reinforcement using immediate, concrete incentives in a progressive reinforcement schedule. CM involves setting frequent (\>1/week), objective goals (usually abstinence or participation in treatment), which patients can achieve to earn tangible rewards (such as cash or vouchers). The DynamiCare smart phone app (iOS/Android) uses CM to incentivize patients to attend scheduled appointments and to submit negative alcohol and drug tests as they are rewarded for these behaviors. The intentions of this project were to assess whether use of the smartphone app as an add-on to treatment as usual could increase treatment retention, increase the percentage of appointments that were kept, and if substance use could be reduced for patients using the app.

Patients were enrolled in the study on a rolling basis from Jan 25, 2019 to March 29, 2019 until the desired cohort group # was reached (n=108). The intervention period (period of time when patients actually used the DynamiCare app) lasted four months from the date of their enrollment.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Substance use disorder (SUD) as a primary diagnosis
* Have and use an Android or iOS smartphone with acceptable capability
* Are willing to participate in home testing and use of the smartphone
* Speak and read the English language adequately to understand smartphone commands and responses
* Are willing to be randomly assigned to receive treatment with or without the smartphone app as an added feature.

Exclusion Criteria:

• N/A
ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic

Since December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19.

Individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death.

Because of the potential interaction between RAS blockers and SARS-CoV-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with COVID-19.

It is crucial to determine whether RAS blockers should be discontinued or not in patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Chronically treated with RAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month).
* Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample with any detection method.
* Patients hospitalized in a non-intensive care unit.
* Pregnancy test at inclusion visit for women of childbearing potential.
* Women of childbearing potential must agree to use adequate contraception according to recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG).

Exclusion Criteria:

* Shock requiring vasoactive agents.
* Acute respiratory distress syndrome requiring invasive mechanical ventilation.
* Circulatory assistance.
* History of malignant hypertension according to the definition of the 2018 ESC/ESH guidelines on hypertension.
* Uncontrolled blood pressure despite the use of five antihypertensive drugs.
* History of nephrotic syndrome.
* History of hospitalization for hemorrhagic stroke in the past 3 months.
* RAS blockers therapy previously stopped \> 48h.
* No affiliation to the French Health Care System "Sécurité Sociale".
* Inability to obtain informed consent.
Cardiovascular Risk in Toledo Population

This epidemiological and observational study is aimed to assess cardiovascular risk (CVR) by investigating the prevalence of CVR factors (CVRF), target organ damage (TOD) and cardiovascular disease (CVD) in general population of the sanitary area of Toledo.

Epidemiological and observational study that is analyzing a sample from the general population aged 18 years or older, randomly selected from a database of sanitary cards stratified by age and gender.

Clinical history, physical examination and complementary tests are being performed.

Total blood and serum samples are being frozen (-85ºC) for future genetic studies. The biobank is currently being registered at the "Virgen de la Salud" hospital of Toledo.

CVR is assessed by SCORE scale calibrated for Spanish population and the Framingham Heart Study scale.

Patients will be periodically visited, with a minimum follow-up of 5 years. Standard statistical analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 years or older, randomly selected from a database of health cards stratified by age and gender

Exclusion Criteria:

* Individulas aged under 18 years.
* Subjects who do not sign the informed consent.
* Subjects that due to different conditions (physical, mental or social) is expected that do not complete the expected follow-up.
Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults

Aging is associated with a decline in muscle mass, strength, and physical function, leading to muscle mass loss and weakness. These concerns can impact an individual's functional independence and quality of life (QOL). Dietary protein stimulates muscle protein growth. Current studies suggest that optimal protein intake for older adults is greater than the Recommended Dietary Allowance. Barriers to consuming protein-rich foods in older adults include reductions in taste and smell, dentition, dexterity, and changes in living situation. Therefore, nutritional interventions are needed to effectively improve eating behaviors, diet quality, and stimulate muscle growth and strength. These interventions will help prevent, manage, and promote muscle mass loss recovery. Older adults may not be aware of their changing nutrient needs and therefore may lack the skills to prepare nutritionally adequate foods properly. Cooking demonstrations, or culinary medicine (CM), can help teach healthy cooking to reduce potential red meat consumption barriers and improve community-dwelling older adults' dietary habits. Thus, CM can be a novel strategy to improve diet quality in older adults and promote and augment at-home cooking. CM is an evidenced-base field that combines skills of preparing, cooking, and presenting food with the science of medicine. This field can help to accomplish potential eating behaviors and health outcome improvements. A tailored CM program can be an effective strategy that could reduce barriers in protein intake that will enable older adults to age well and productively.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* physically active
* able to cook for oneself
* willing to complete two blood draws

Exclusion Criteria:

* \<65 years old
* sedentary lifestyle
* bleeding disorder
* heart pacemaker
* type 1 diabetics and type 2 diabetics taking insulin
* current smokers
* amputees
Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™

In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™.

Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks.
* Born to a mother proven seronegative for HBsAg.

Exclusion Criteria:

* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine, with the exception of oral polio vaccine (OPV).
* Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and/or Hib.
* History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Hib disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or history.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Brain Imaging: Cocaine Effects & Medication Development - 5

The purpose of this study is to define temporal profile of brain activation (rCBF) using Xenon-SPECT and O 15-PET.


Eligibility Criteria:
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