cyrilzakka/clinical-trials huggingface dataset:
Enhancing Support for Women at Risk for Heart Disease

To test a practical, theory-based intervention to achieve long-term behavior change for postmenopausal women with Type 2 diabetes at high risk for developing coronary heart disease (CHD).

BACKGROUND:

The overall goal of this study was to test a practical, theory-based intervention to achieve long-term behavior change for women with Type 2 diabetes at high risk for developing coronary heart disease (CHD). Epidemiological and clinical studies suggest that diabetes is associated with increased risk for CHD that is greater in women than in men. CHD is a major cause of death and functional limitations in women, but the vast majority of CHD studies have primarily involved middle-aged men. There is convincing research evidence that healthy lifestyle behaviors, including low-fat diet, physical activity, stress management, smoking cessation, and social support, can reduce CHD risk

The study was initiated in response to a Request for Applications released in October 1997 by the National Institutes of Health Office of the Director on "Innovative Approaches to Disease Prevention Through Behavior Change."

DESIGN NARRATIVE:

The study was a randomized trial to compare short-term (6-month) outcomes in women receiving usual care compared to a modified Ornish-type comprehensive lifestyle management (CLM) intervention. Participants (N = 279) were randomized to usual care (UC) or Mediterranean Lifestyle Program, a lifestyle change intervention aimed at the behavioral risk factors (eating patterns, physical activity, stress management, and social support) affecting risk for CHD in postmenopausal women with type 2 diabetes. After 6 months, women in the CLM condition were randomized to one of two approaches for providing support either lay-led group support or personalized computer-based support - to evaluate these strategies in enhancing longer-term maintenance of effects. Outcomes included multiple CHD lifestyle behaviors (e.g., dietary intake, exercise levels, stress management, smoking cessation), physiological risk factors associated with CHD (e.g., serum lipids, hypertension, weight, vascular reactivity), HbA1c (glycated hemoglobin, a measure of diabetes), and quality of life (e.g., depression, functioning).

Eligibility Criteria:
No eligibility criteria
Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor

Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Histologically or cytologically confirmed malignant lymphoma or solid tumor
* After the failure of standard treatment
* KPS \>70 or ECOG PS 0-2
* Adequate bone marrow, renal, and liver functions
* Expected survival at least 3 months
* Informed consent

Exclusion Criteria:

* Pregnancy or lactating woman
* HIV patients
* Prior exposure to cell-based therapy
* Hypersensitivity to interleukin-2
* Patients with autoimmune disease
Feasibility and Usability of LaparoGuard

LaparoGuard is intended as an adjunctive safety system for laparoscopic surgery. The system allows surgeons to virtually annotate a safe anatomical volume inside the body cavity of the patient during a laparoscopic surgery. The surgeon then receives notification throughout the procedure whenever a tracked rigid instrument has exited that volume. This open label, prospective, feasibility, single site, multi-investigator trial will evaluate the feasibility and usability of the LaparoGuard system during laparoscopic surgical procedures.

PHASE 1) LaparoGuard will be used as an adjunctive tool for maintaining safety during procedures performed by expert surgeons. The pre-operative instructions for use will be evaluated along with ease of procedural setup, as reported by pre-operative nurses. The intraoperative instructions for use will be evaluated along with system usability, as reported by the expert surgeons. The perceived clinical utility will be judged by expert surgeons. Postoperatively, the system data will be reviewed. This phase will include 4-6 subjects.

PHASE 2) Novice surgeons will conduct procedures alongside expert surgeons. Expert surgeons will establish the safe zone. LaparoGuard will record all deviations, speed and smoothness of tip movements. The training utility of LaparoGuard will be assessed by both the expert and novice surgeons. This phase will include 4-6 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing routine laparoscopic procedures. Examples include (non-exhaustive): operative laparoscopy, appendectomy, cholecystectomy, colon resection, inguinal or diaphragmatic hernia repairs.
* Ability to read and understand English
* Consent to use of the LaparoGuard system in their procedure (18 yrs or older)

Exclusion Criteria:

* Unwilling to sign informed consent
* Simple diagnostic laparoscopy (can be included if conversion to operative laparoscopy)
* Surgeries which require conversion to laparotomy for patient safety reasons
Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education

To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses. The purpose of this local study, in cardiac surgery department, is to evaluate the therapeutic impact of two methods of comprehensive education, one conventional and performed by nurses service, less elaborate, relying solely on the book Information from The National Security Agency of Medicines and Health Products, the other based on more detailed documents created by a multidisciplinary group. Various studies show that the effect of therapeutic education is observed only during the first six months and then disappears.

This study is the first French study evaluating the impact of a comprehensive education to oral anticoagulation according to the latest recommendations of the National Security Agency of Medicines and Health Products and the French National Health Authority.

To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses. The purpose of this local study, in cardiac surgery department, is to evaluate the therapeutic impact of two methods of comprehensive education, one conventional and performed by nurses service, less elaborate, relying solely on the book Information from The National Security Agency of Medicines and Health Products, the other based on more detailed documents created by a multidisciplinary group. Various studies show that the effect of therapeutic education is observed only during the first six months and then disappears.

This study is the first French study evaluating the impact of a comprehensive education to oral anticoagulation according to the latest recommendations of the National Security Agency of Medicines and Health Products and the French National Health Authority.

Eligibility Criteria:
Inclusion Criteria:

* Adults, male or female, over 18 years
* After cardiac surgery
* Requiring an oral anticoagulant in the long term (\> 12 months)
* Accepting the principle of extended follow-up
* Voluntary Consent, written and signed by patients
Diet and Muscle Function In Older Adults

This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adults.

This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adult

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older

Exclusion Criteria:

* Diabetic
* Acute symptoms of cardiovascular disease or congestive heart failure
* uncontrolled hypertension
* supplemental oxygen consumption at rest or during exercise
* lactose intolerance
* inability to ride a stationary cycle
Lenalidomide Adherence in Older Adults

To describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65
* Receiving lenalidomide for treatment of multiple myeloma.
* Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
* Able to read and understand English.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Estimated life expectancy \<6 months.
* Anticipated duration of lenalidomide therapy \<3 months.
* Residing in a nursing facility where their medications are administered to them OR patient reports they do not self-administer their own medications.
Family Peer Navigator for Early Psychosis for Black Families

Building upon formative research, this mixed methods study will be conducted in three phases to develop, refine, and pilot-test a multi-component Family Peer Navigator model designed to increase access to and initial engagement in coordinated specialty care for early psychosis among Black/African American families.

The overall goal of this mixed methods study will be conducted in three phases to develop, refine, and pilot-test a multi-component Family Peer Navigator model designed to increase access to and engagement in coordinated specialty care programs among Black/African American families. Phase II will recruit 10 family member participants to complete a four-month open trial to refine the Family Peer Navigator model. During Phase III, a total of 40 Black/African American families will be recruited to participate in a randomized pilot trial of the Family Peer Navigator model against a low-intensive care coordination in two coordinated specialty care programs to assess acceptability, feasibility, and preliminary impact.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Identifies as Black/African American
3. Loved one who meets criteria for risk of psychosis with a total score of ≥ 3 on the Prodromal Questionnaire- Brief Version

Exclusion Criteria:

1. Family members who cannot understand the consent process
2. Non-English speaking adults
3. Black/African American families referred to coordinated specialty care and who have already been determined eligible for services by providers.
Thiamine as a Metabolic Resuscitator After Cardiac Arrest

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA). .

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA). Patients who have sustained return of spontaneous circulation (ROSC) after OHCA and have a lactate of 3 or greater will be eligible for the study. Enrolled patients will be randomized to intravenous thiamine 500mg twice daily for 5 doses or matching placebo (100cc normal saline). Blood will be drawn at several time points and patients will be connected to a noninvasive monitor for continuous measurement of global oxygen consumption. The primary endpoint is change in lactate level. Secondary endpoints include change in pyruvate dehydrogenase activity, change in cellular and global oxygen consumption, change in NSE and S100 (biomarkers of neurologic injury) and CPC-E score (a score that assesses neurologic and functional impairment) at hospital discharge, 30 and 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age ≥ 18 years)
* Cardiac arrest occurring with sustained (\> 20 minutes) return of spontaneous circulation (ROSC)
* Within 4.5 hours of cardiac arrest event
* Lactate \>/=3

Exclusion Criteria:

* Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
* Traumatic etiology of arrest
* Comfort measures only or anticipated withdrawal of support within 24 hours
* Protected populations (pregnant women, prisoners)
* Known allergy to thiamine
The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk (FLAVASCULAR Study)

Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease (CVD). The protective effect may be ascribed to compounds contained within these foods, called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine. There is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to determine the acute and chronic effects of apple derived flavanols on some risk markers for CVD.

This study is a single arm randomized, 4-phase crossover design.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 50 years of age
* Systolic blood pressure 130 - 159 mmHg

Exclusion Criteria:

* History of cardiovascular events such as stroke, myocardial infarction trans- ischaemic attacks or peripheral vascular disease
* Kidney or liver disease/problems
* Diabetes
* Asthmatics (unless no medication taken for 1 year - occasional use will be assessed on an individual basis)
* Prescribed anti-hypertensive medication
* HRT (unless the participant has used the therapy for ≥ 6 months)
* Lipid lowering therapies e.g. statins
* Other medications that may affect any of the study outcome measures e.g. vasodilators (this will be assessed on a case by case basis)
* Current smoker (or stopped for less than 3 months)
* Throat surgery or neck injury
* Allergy to apples
* Consumption of fish oil supplements unless willing to discontinue them up for 4 weeks preceding the start of the study and for the duration of the study. (All other supplements will be assessed on a case by case basis)
* Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
* Parallel participation in another research project which involves dietary intervention
* Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 ml.
* Has donated or intends to donate blood within 16 weeks prior to or during the study period.
* Depressed or elevated blood pressure measurements (\<90/50 or 95/55 if symptomatic or \>160/100 (mmHg)) during the course of the trial.
An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naive Cross-Reacting Immunologic Material (CRIM[-]) Patients With Infantile-Onset Pompe Disease

The purpose of this study was to evaluate the efficacy, clinical benefits and safety of a prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa (Myozyme®) in patients with infantile-onset Pompe disease.

The objectives were to assess the efficacy of a prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa, as assessed by anti-recombinant human acid alpha-glucosidase (anti-rhGAA) antibody titers, and antibodies that inhibit the activity and/or uptake of alglucosidase alfa; to evaluate the clinical benefit as measured by overall survival, ventilator-free survival, left ventricular mass index (LVMI), gross motor function and development, disability index and the incidence of adverse events (AEs), serious adverse events (SAEs), and clinical laboratory abnormalities.


Eligibility Criteria:
Inclusion Criteria:

* The patient's legal guardian(s) must have provided written informed consent prior to any study-related procedures being performed
* The patient must have had a clinical diagnosis of Pompe disease as defined by documented acid alpha-glucosidase (GAA) deficiency (deficient endogenous GAA activity) in skin fibroblasts, muscle, or blood, or 2 GAA mutations. Consent was also sought from the biological parent(s) for parental GAA mutational analysis, but was not a requirement for study eligibility
* The patient must have not received Myozyme® or any rhGAA therapies prior to enrollment in the study
* The patient must be CRIM negative via Western Blot analysis performed on skin fibroblasts or via 2 known CRIM negative mutations (in which case CRIM status was to be confirmed by Western Blot analysis after enrollment)
* The patient's legal guardian(s) must have the ability to comply with the clinical protocol

Exclusion Criteria:

* The patient had any medical condition that, in the opinion of the Investigator, could be exacerbated/precipitated by or interfere with the study regimen or assessments; such conditions may include but were not limited to human immunodeficiency virus, cancer, Hepatitis B, Hepatitis C, Cytomegalovirus, Herpes Simplex, John Cunningham (JC) virus, Parvovirus, or Epstein Barr virus or tuberculosis
* The patient had used any investigational product within 30 days prior to study enrollment
* The patient had or was required to have any live vaccination within 1 month prior to enrollment
Efficacy and Safety Study of FID 119515A

The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.

Subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.

Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent.
* Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
* At least a 3 month documented history of dry eye in both eyes.
* TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Any evidence of ocular infection or inflammation within 30 days prior to Screening.
* Any ocular surgery.
* Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
* Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy.
* Use of topical ocular prescription or non-prescription medications within 30 days of Screening.
* Participation in any other clinical trial within 30 days prior to Screening.
* Other protocol-defined exclusion criteria may apply.
Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and will be hold in place by a secondary dressing for maintaining the moist wound environment. The study is aimed to demonstrate superiority over a standard wound treatment for chronic venous leg ulcers. The primary efficacy variable is time to healing.


Eligibility Criteria:
Inclusion Criteria:

* At least one chronic venous leg ulcer fulfilling all of the following criteria:

  * Size: \>/= 5 cm2 and \</= 40 cm2 (measured by Visitrak Wound Measurement System)
  * Duration: \>/= 3 month \< 5 years
  * Location: Between and including knee and ankle
  * Depth: Involving dermis, with no exposed muscle, tendon or bone. Characterized by a viable wound bed with granulation tissue
  * The etiology of the ulcer as "venous" is proven by Duplex or Doppler sonography and with ankle/brachial arterial Doppler pressure index \> 0.8 (exclusion criterion for peripheral arterial disease) and \< 1.3 (exclusion criterion for medial sclerosis), or with a laser Doppler value \> 40
* Treatment with active wound care agents paused for 14 days before start of study treatment

Exclusion Criteria:

* Only ulcers of other than venous etiology, e.g., diabetic ulcers or ulcers resulting from electrical, chemical, or radiation insult, after contact eczema, etc.
* History of radiotherapy to the target ulcer site
* Signs of infection as defined by rubor, dolor, calor, tumor, functio laesa. Fever (38°C sublingual, rectal, or ear), rigors, or leukocytosis will be considered as signs of infection in the context of the general appearance of the wound
* Target ulcer lacking any sign of granulation tissue (bradytrophic wound bed)
* Presence of necrotic tissue
* Presence of fistula
* History of connective tissue disease, e.g., systemic lupus erythematodes, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
* Uncontrolled congestive heart failure
* Malnutrition (albumin \< 2.5 g/dl; to be measured if clinical signs of malnutrition are being observed)
* Uncontrolled diabetes (HbA1c \> 8 %)
* Previous organ transplantation
* Active malignant disease
* Severe rheumatoid arthritis
* Undergoing haemodialysis
* Active sickle cell disease
* Patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
* Pregnant or nursing women
* Woman of childbearing potential who are not practicing acceptable methods of birth control during the investigation period
* Known allergy to any of the devices' constituents
Automated Video-Assisted Smoking Treatment for People Living With HIV

This study will evaluate if Automated Treatment performs better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.


Eligibility Criteria:
Inclusion Criteria:

* smoked \>/=100 cigarettes in lifetime
* English or Spanish speaking
* Currently smoke \> 5 cigarettes/day
* Willing to make a quit attempt within 1 week of enrollment
* HIV positive
* Process a smartphone compatible with the project app
* Have a valid email address

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Current use of smoking cessation medications
* Enrolled in a smoking cessation study
* Household member enrolled in the study
* Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone