cyrilzakka/clinical-trials huggingface dataset:
Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.

In a randomized, four-phase cross-over study the effect of simulated microgravity (13 days of bed rest), energetic restriction (-25%, fat reduced), and their combination on endothelium-dependent and -independent vasodilation will be compared with ambulatory control conditions. Using venous occlusion plethysmography cumulative intraarterial dose-response curves to endothelium-dependent (acetylcholine) and -independent (sodium nitroprusside) vasodilators will be constructed in 10 healthy male volunteers before and on day 13 of each of the four intervention periods.

Eligibility Criteria:
Inclusion Criteria:´

* Healthy, male volunteers, age: 18-40
* Able and willing to give written informed consent

Exclusion Criteria:

* Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, hyperhomocysteinaemia)
* Regular medication and/or treatment with drugs within the last 4-6 weeks (exclusion has to be decided in each case)
* Acute or chronic illness
* Participation in clinical trial/blood donation within 2 month before the study
* Nicotine during 1 year before the study; drug and/or alcohol abuse.
Personalized Translational Platform for Biomarker Discovery in Brain Tumors

The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue) biomarkers will better predict early brain tumor response to treatments and will be more reliable prognostic markers in patients with malignant brain tumors.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or suspected high grade glioma ≥ 1cm in diameter on postoperative anatomic imaging (contrast MRI), prior to initiation of chemoXRT
* Anticipated survival ≥6 months
* Able to give informed consent
* Capable of undergoing MRI and PET scans without the need for sedation or general anesthesia
* Male or Female

Exclusion Criteria:

* Prior radiation therapy and chemotherapy to the brain
* Active intracranial infection or nonglial brain mass.
* Recent large intracranial hemorrhage (\<1 month)
* Expected survival \<6 months
* Pregnant or nursing
* Renal failure
* Lives far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.
Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
Patient-centered Information on Permanent Contraception

The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives.

Participants will:

* Complete a baseline survey
* Receive access to web-based educational resources
* Complete a brief follow up survey immediately after exploring these web-based resources
* Complete a follow-up survey 3 months after enrolling

The investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization.

This study evaluates the potential benefits of web-based resources to prepare patients considering tubal sterilization to effectively communicate their personal values and priorities to their clinicians, informed by recent patient centered outcomes research (PCOR) comparing interval tubal sterilization to long-acting reversible contraceptives. The investigators hypothesize that patients provided with information on the comparative safety and effectiveness of all available long acting contraceptives will be more likely to obtain contraceptive care that aligns with their personal preferences. The short-term goal of this work is to support patient-centered contraceptive care by increasing knowledge of and perceived access to all available long acting contraceptives among those who wish to avoid future pregnancy. The long-term goal of this work is to increase the proportion of women who are using a method of contraception that aligns with their personal preferences, reduce the proportion of women who regret having undergone a permanent contraceptive procedure, and reduce racial disparities in surgical sterilization.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported fertility
* Have a strong desire to avoid future pregnancy
* Speak English or Spanish

Exclusion Criteria:

* Current pregnancy
* The inability to speak English or Spanish
* Prior tubal sterilization or "Essure" procedure
* Menopause
* Infertility
* Hysterectomy
Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot

The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure. Secondary objectives include evaluating the acceleration of wound closure, facilitation of surgical closure, incidence of foot salvage, and incidence of wound complications.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of a diabetic foot amputation wound up to the transmetatarsal region of the foot
2. Evidence of adequate perfusion by one of the following on the affected extremity, (within the past 60 days):

   * Dorsum transcutaneous oxygen test (TcPO2) with results of ≥30 mmHg, or
   * Ankle brachial index (ABIs) with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmHg, or
   * Doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg.
3. Age ≥ 18 years of age
4. HbA1c ≤ 12% (collected within the last 90 days.)
5. Evidence of adequate nutrition by one of the following:

   * Lab results reflecting Pre-Albumin ≥16 mg/dl and Albumin level is ≥3 g/dl (during the seven days prior to the study period), or
   * A nutritional consult will be done and with appropriate supplementation started. Proper documentation on (case report forms)CRFs is needed.

Exclusion Criteria:

1. Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group
2. Wounds resulting from electrical, chemical, or radiation burns, or venous insufficiency
3. Untreated infection or cellulitis at site of target wound
4. Presence of untreated osteomyelitis
5. Collagen vascular disease
6. Malignancy in the wound
7. Presence of necrotic tissue in the wound
8. Uncontrolled hyperglycemia
9. Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
10. Prior V.A.C.® therapy within 30 days.
11. Current or prior normothermic (Warm-UP®) or hyperbaric oxygen (HBO) therapy within 30 days.
12. Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren)
13. Current or prior treatment with skin or dermal substitutes and dressings (Examples: Apligraf, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.
Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)

This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.

The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars plana vitrectomy for macular edema due to preretinal membranes. Specifically, we will examine its effect on macular edema (measured by OCT), and visual recovery (measured by visual acuity). We will examine its use in patients who underwent pars plana vitrectomy for macular edema with associated taut membrane. This will be a prospective pilot study with patients to receive an Ozurdex implant at the time of vitrectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are undergoing pars plana vitrectomy for:

   * Epiretinal membrane/vitreomacular traction or
   * Diabetic macular edema
2. Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness)
3. Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.
4. Age between 18-85 years old

Exclusion Criteria:

1. Age \< 18 years or \> 85 years
2. History of macular edema due to diseases other than those in the inclusion criteria in the study eye

   * History of active inflammatory eye disease (uveitis) (within 3 months)
   * History of ocular malignancy and/or ocular/orbital irradiation
   * History of recent retinal vein occlusion (within 6 months)
   * History of neovascular age-related macular degeneration or choroidal neovascular membrane \[
   * History of juxtafoveal telangiectasia
   * History of Coat's disease
   * History central serous choroidoretinopathy
   * History of previous infectious retinitis (toxoplasmosis, acute retinal necrosis, tuberculosis, etc)
3. Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis)
4. Patients who are cognitively impaired or those who are unable to provide informed written consent
5. Patients with a history of glaucoma in the study eye (defined as increased cup to disc ratio with associated nerve damage. Patients with ocular hypertension controlled by topical glaucoma drops (maximum 3) will not be excluded).
6. Patient with recent intravitreal injections of steroids or anti-VEGF medications in the study eye (within past 4 weeks).
7. Patients with recent periocular steroid injection (within past 4 weeks) in the study eye
8. Patients on topical NSAIDS drops (patient will be eligible if they discontinue use of topical NSAIDs at time of study enrollment) in the study eye
Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

The purpose of this study is to learn more about why some people are at greater risk for oral emergency contraceptive failure while others are not. The investigators want to learn if genetic differences impact the risk of emergency contraception failure.

Each of us can respond differently to a drug or medication based on our genetics. An emergency contraceptive, ulipristal acetate or UPA, normally works by stopping or delaying the ovary from releasing an egg (ovulation). Our bodies break down UPA in order to use it through a system call the cytochrome P450 pathway but this pathway can be faster or slower depending on our genetics. The investigators want to learn more about how our individual genetic differences in this pathway change how the ovary responds to UPA. The overall goal of this research is to improve the effectiveness of emergency contraception for all people.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy women
* Aged 18-40
* regular menses (every 21-35 days) experiencing ovulatory cycles proven by a single progesterone level of 3 ng/mL or greater during the luteal phase of the screening cycle.

Exclusion Criteria:

* Pregnant, seeking pregnancy, or breastfeeding
* Known allergy to study medication
* Recent use of hormonal contraception
* Irregular periods (\<21 days or \>35 day cycles)
* Routine use of nonsteroidal anti-inflammatory drugs
* Metabolic disorders
* Smoking
* Any condition that would preclude the provision of informed consent
* Using drugs (within 2 weeks of study enrollment) known to interfere with the metabolism of UPA as well as drugs known to be CYP3A4 inducers, inhibitors, or CYP3A drug substrates
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-negative Adults.

Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Booster vaccination will be given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control.

The safety and immunogenicity of 2 antigen doses in PPD-negative adults will be evaluated. In addition, 2 active comparator groups of volunteers will receive the vaccine alone without an immunostimulant and 1 control group will receive the adjuvant (AS02) alone to assess the true effect of the candidate tuberculosis vaccine (Mtb72F/AS02).

Eligibility Criteria:
INCLUSION CRITERIA:

* Written informed consent
* Healthy PPD-negative volunteers aged 18 to 45 years
* No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.
* Seronegative for HIV 1 and 2, HBsAg, and HCV
* Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
* Females : Non pregnant, must use adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

EXCLUSION CRITERIA:

* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
* History of prior Bacillus Calmette-Guérin (BCG) vaccination.
* History of documented exposure to Mycobacterium tuberculosis
* History of prior vaccination with experimental Mycobacterium Tuberculosis vaccines or experimental products containing MPL or QS21.
* Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
* History of hypersensitivity to vaccines or vaccine components
* History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine
Patient Controlled Oral Analgesia for Postoperative Pain Management After Total Knee Replacement

Patient Centered Care (PCC) is "an approach that consciously adopts the patient's perspective...about what matters" (Gerteis, Edgeman, Levitan, Walker, Stokes, Cleary, Delbanco, 1993). Experiencing pain is the most common concern of patients before surgery - even ahead of whether the surgery would improve their condition (Apfelbaum, 2003). Current standard of practice for post-operative pain management in most acute care hospitals today is intravenous patient controlled analgesia (IV PCA). However, despite the fact that patients prefer IV PCA because it affords them greater control and provides them with better pain relief (Ballantyne, Carr, deFerranti, Suarez, Lau, Chalmers, Angelillo, Mosteller, 1998 ; Rawal, 2001), hospitals routinely take control of pain medications away from patients once they are switched to pain tablets. Patients must then wait, in pain, for their nurse to bring them pain tablets.

Patient controlled oral analgesia (PCOA) has been utilitzed in several centers in the US and Germany. Preliminary evidence from the literature seems to indicate that the benefits of PCOA are similar to IV PCA including increased patient satisfaction and better pain control (Striebel, Romer, Kopf, Schwagmeier ,1996; Striebel, Scheitza, Philippi, Behrens, Toussaint, 1998). At the Toronto Western Hospital, University Health Network, we have successfully implemented a PCOA program on two surgical units (Orthopedics/Rheumatology and Spinal). The purpose of this study is to compare usual nurse administered oral analgesia to PCOA with respect to pain, patient satisfaction, and passive range of knee motion in postoperative total knee replacement patients.


Eligibility Criteria:
Inclusion Criteria:

* able to read and write English
* post elective total knee replacement surgery (primary or revision)
* already on IV PCA
* age 18-80
* able to tolerate oral medication
* able to physically open a childproof vial independently (including the absence of any significant problems with manual power, dexterity or visual acuity)
* able and willing to complete Oral PCA flowsheet

Exclusion Criteria:

* history of substance abuse
* history of sleep apnea
* episode(s) of confusion, disorientation during this admission
* episode(s) of respiratory depression during this admission
* history of major psychiatric disorder pregnancy
Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women

Aging is characterized by a progressive loss of multiple physical and cognitive abilities. From these changes, the most important one is the loss of muscle mass, which has been called "sarcopenia". Resistance exercise is a therapeutic approach for sarcopenia, nevertheless there is no universal consensus. Therefore, this research is interested in determining the effect of a resistance exercise program on physical performance and/or functional status in sarcopenic older women. The main study hypothesis is that a program of resistance exercise will improve physical performance and functional status in sarcopenic older women compared against general recommendations.

This is a single-blind, controlled clinical trial, including women\> 70 years, living in the community with sarcopenia. Those who agree to participate, will be randomly assigned to one of the following groups:

1. Resistance Exercise Group
2. General Recommendations Group (control) The study will last 24 weeks, with 4 measurements performed at baseline, week 6, 12 and 24. Multilevel models (random effects) will be constructed for the comparison between the two groups. Tests will be conducted with a P=0.05 and confidence intervals at 95%. This protocol has been approved by the local ethics committee.

Study withdrawn.

Eligibility Criteria:
Inclusion Criteria:

* Body mass composition by BIA with skeletal muscle mass \<6.76kg/m2
* Speed gait of \<0.8m/sec
* Handgrip strength (adjusted for BMI) less than 20kg

Exclusion Criteria:

* Current diagnosis of malnutrition (BMI \<19kg/m2)
* Decompensated heart failure (NYHA III or IV)
* Hemiplegia or hemiparesis due to cerebral vascular disease
* Exacerbation of chronic obstructive pulmonary disease
* Dementia (any type, moderate or severe stage)
* Uncontrolled diabetes mellitus (glycosylated hemoglobin \>8%)
* Severe pain in hips, knees or ankles
* Fracture of lower limb in the last 6 months
* Myocardial infarction within the past 6 months
* Severe hypertension (SBP \> 180mmHg or DBP \> 110 mmHg)
* Orthostatic hypotension
Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination

The purpose of this study is to explore whether combining the first post-hospital newborn provider visit and lactation consultation into a single appointment can enhance rates of successful breastfeeding initiation and continuation at predefined intervals (e.g., one week, one month, two months, three months, four months, six months, and 12 months postpartum).

This interventional, comparative effectiveness study investigates the impact of integrating the first newborn outpatient provider and lactation consultant visits, potentially reducing appointments for new mothers while ensuring early lactation support. The outcomes, including breastfeeding continuation rates and maternal satisfaction, will be measured against the conventional separate visit model. The ultimate goal is to prolong breastfeeding duration, enhance care quality, improve efficiency, and enrich patient experience.

Eligibility Criteria:
Inclusion Criteria:

* Mothers aged greater than or equal to 18 years.
* Mothers who are able to provide informed consent for participation in this study.
* Mothers registered as patients at Mayo Clinic Health System Northwest Wisconsin.
* Mothers who have given birth within the past four days prior to enrollment into this study.
* Mothers who intend to breastfeed their newborns.
* Mothers who are willing and able to participate in this study.
* Mothers who are able to communicate in English.
* Mothers with the ability to connect to the internet and complete electronic data collection.

Exclusion Criteria:

* Mothers who are unable or unwilling to provide informed consent for participation in this study.
* Mothers less than 18 years of age.
* Mothers unable to complete study procedures or follow-up visits.
* Mothers with medical complications that could interfere with breastfeeding (e.g., breast reduction).
* Mothers who have no intention to breastfeed their newborns.
* Mothers who are unwilling to follow up with lactation.
* Infants who have already had their first postpartum outpatient provider visit.
* Pre-term infants (less than 37 weeks).
* Special care admission greater than two days.
* Length of stay or anticipated LOS greater than four days.
* Transfer to an outside facility.
* Inability to communicate in English.
* When slots are no longer available.