Kornimate/medical-research-clean huggingface dataset:
effects of diet manipulation on women in the curves program

Conditions: Diet, Carbohydrate-Restricted

Summary: the purpose of this study is to look at the effects of a carbohydrate restricted, high protein, high fat diet on weight loss and health outcomes in women participating in the curves fitness and weight loss program.

the purpose of this study is to determine if a carbohydrate restricted, high protein, high fat diet (20% carbohydrate, 45% protein, 35% fat; cc-ii) promotes more favorable changes in weight loss and health outcomes compared to a traditional high carbohydrate, low protein, low fat diet (55% carbohydrate, 15% protein, 30% fat; aha) and the curves moderate carbohydrate restricted, high protein, and low fat diet (30% carbohydrate, 45% protein, 25% fat; cc-i).

Eligibility criteria:
inclusion criteria: * the participant is an apparently healthy female * the participant is between the ages of 18 and 60 exclusion criteria: * the participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months * the participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease * the participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications * the participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, hmb), anabolic/catabolic hormone levels (androstenedione, dhea, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months * the participant is willing to participate in a regular moderate exercise program
optimization of blood levels of 25(oh)-vitamin d in african americans

Conditions: Vitamin D Deficiency

Summary: two-thirds of the us population, particularly african americans (aa), is at risk for inadequate or deficient 25-hydroxy-vitamin d (25(oh)vd). epidemiological studies demonstrate an association between better health outcomes and higher blood levels of 25(oh)vd . randomized controlled clinical trials have shown that, while supraphysiological high doses of vd are needed to achieve adequate blood levels of 25(oh)vd, not all subjects respond to them. recent studies have also questioned the therapeutic effects of high-dose vd supplementation. severe vd deficiency has been associated independently with the future risk of mild cognitive impairment (mci) and dementia. a reduction in gsh and an increase in the oxidative stress levels of serum, erythrocytes, and circulating lymphocytes has been observed in mci and alzheimer disease, findings similar to those in vd deficient persons. scholarly reviews conclude that excess oxidative stress is one of the major risk factors for ad and support a potential therapeutic role for l-cysteine (lc, a gsh precursor) and vitamin d (vd) supplementation in the treatment of alzheimer disease symptoms. this application presents the investigators' design for a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that supplementation with vd in combination with l-cysteine (lc) is more successful at optimizing the statuses of 25(oh)vd \[biological signatures\] and simultaneously decreasing tnf-α, ir \[functional or clinical outcomes\], and oxidative stress, suggesting a better therapeutic approach compared with supplementation with vd alone in aa subjects.


Eligibility criteria:
inclusion criteria: * african american volunteers only * participants between the ages of 18 and 65 * must be in good general health * women with negative pregnancy tests exclusion criteria: * subjects with diabetes, heart disease, sickle cell disease, or epilepsy * subjects with serum positive pregnancy test or breastfeeding

Keywords: african american; vitamin d; insulin resistance alzheimer's disease
haptoglobin and iron in parkinson's disease

Conditions: Parkinson's Disease

Summary: this is a case/control epidemiology study to identify what are the iron-metabolism abnormalities in parkinson's disease (pd) patients, and risk factors relevant to pd predisposition.

a total of 342 participants, 100 pd patients and 242 age- and gender matched controls, were included in the study. all study participants were seen for one study visit in the morning at one of two bastyr university clinics in the seattle area. study participants were fasting at the time of the visit. during the study visit, participants donated a blood sample for the blood tests and complete an epidemiology questionnaire. a subset of 51 of the study participant who were seen for the visit at bastyr university, underwent brain scan and magnetic resonance imaging (mri), at the university of washington department of radiology. the mri part of the study aims at estimating brain iron levels.

Eligibility criteria:
inclusion criteria for the controls, for the blood draw and epidemiology visit: * volunteers should be of age between 52 and 82 years of age, males of females. exclusion criteria for the controls: * presence of a neurodegenerative disease, * presence of active cancer under treatment, * hiv sero-positivity, hepatitis b, c, of a sero-positivity * rheumatoid arthritis * recent blood donation (less than three months before the visit). * fever at the time of the visit inclusion criteria for the parkinson's disease patients: diagnosis of parkinson's disease (ukbb clinical criteria). exclusion criteria for the parkinson's disease patients, for the blood draw and epidemiology visit: * presence of other neurodegenerative diseases, apart for parkinson's disease * two or more family members with parkinson's disease * presence of active cancer under treatment * hiv sero-positivity, hepatitis b, c, of a sero-positivity * rheumatoid arthritis * recent blood donation (less than three months before the visit). * fever at the time of the visit exclusion criteria for the magnetic resonance imaging: * presence in the body of a ferro-magnetic metallic foreign object such as, but not limited to: * a cardiac pacemaker * aneurism clip * neuro-stimulator * surgical clip * artificial limb or joint * orthopedic items, such as screws, nails, pins, rods, * any metallic foreign body from a previous injury, bullets, shrapnels, metal slivers. * exclusion criteria for mri is also the presence of claustrophobia

Keywords: iron metabolism mri risk factors haptoglobin phenotype
evaluation of a new cardiac pacemaker

Conditions: Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block; Normal Sinus Rhythm With 2 or 3° AV or BBB Block; Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings

Summary: an evaluation of a safety and performance of a new cardiac pacemaker


Eligibility criteria:
inclusion criteria: * subject must have one of the following clinical indications: 1. chronic atrial fibrillation with 2 or 3° av or bifascicular bundle branch block (bbb block) ; or 2. normal sinus rhythm with 2 or 3° av or bbb block and a low level of physical activity or short expected lifespan (but at least one year); or 3. sinus bradycardia with infrequent pauses or unexplained syncope with ep findings; and * subject ≥18 years of age; * subject has life expectancy of at least one year; * subject is not enrolled in another clinical investigation; * subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; * subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the ec; * if female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal. exclusion criteria: * pacemaker dependent; * known pacemaker syndrome, have retrograde va conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; * hypersensitivity to \< 1 mg of dexamethasone sodium phosphate; * mechanical tricuspid valve prosthesis; * pre-existing pulmonary arterial (pa) hypertension or significant physiologically-impairing lung disease; * pre-existing pacing or defibrillation leads; * current implantation of an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy (crt); * presence of implanted vena cava filter; * presence of implanted leadless cardiac pacemaker; * pregnant or breastfeeding.
the study of cctm and common diseases

Conditions: Hypertension; Diabetes Mellitus; Chronic Obstructive Pulmonary Disease Moderate; Coronary Artery Disease; Obesity

Summary: this study aimed to explore the associations between constitutions of traditional chinese medicine (tcm) and common disease (cd). a large-scale, community-based, cross-sectional study was performed to investigate the associations. a total of 3748 participants were available for analysis in this study. the assessment of constitution of tcm was based on recommendations of association chinese medicine in china. in this study, the diagnosis of cd was based on self-reported medical history. the associations were analyzed using univariate and multivariable logistic regression (mlr).

this study aimed to explore the associations between constitutions of traditional chinese medicine (tcm) and common disease (cd). a large-scale, community-based, cross-sectional study was performed to investigate the associations. a total of 3748 participants were available for analysis in this study. the assessment of constitution of tcm was based on recommendations of association chinese medicine in china. in this study, the diagnosis of cd was based on self-reported medical history. the associations were analyzed using univariate and multivariable logistic regression (mlr).

Eligibility criteria:
inclusion criteria: * participants aged 30-90 years were recruited from rural and urban communities in shanghai. exclusion criteria: * severity renal and liver function abnormal and pregnant woman
radiation therapy in preventing brain metastases in patients with small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. it is not yet known which regimen of radiation therapy may be more effective in preventing brain metastases. purpose: randomized phase iii trial to study the effectiveness of radiation therapy in preventing brain metastases in patients who have small cell lung cancer that has been diagnosed within the past year.

objectives: i. compare the efficacy of low dose versus high dose prophylactic cranial irradiation in preventing brain metastases in patients with small cell carcinoma of the lung. ii. determine the neuropsychiatric status of these patients before and after treatment. outline: this is a randomized, multicenter study. the right or left hemisphere of each patient's brain are randomized to one of two treatment arms. all patients receive whole brain radiotherapy 5 days a week over 2.5 weeks for a total of 12 fractions. arm i: patients receive radiotherapy to the left cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy. arm ii: patients receive radiotherapy to the right cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy. patients with extensive disease may also receive thoracic radiotherapy, if not administered previously. patients are followed at 1, 3, 6, 9, and 12 months, and then every 6 months thereafter. projected accrual: approximately 16-40 patients will be accrued for this study within 1-4 years.

Eligibility criteria:
disease characteristics: histologically confirmed small cell carcinoma of the lung diagnosed within the past year limited stage must have completed prior chemotherapy with thoracic irradiation extensive stage must have completed prior chemotherapy with or without thoracic irradiation no more than 24 gy of prior prophylactic cranial irradiation to the whole brain no brain metastases patient characteristics: age: not specified performance status: karnofsky 50-100% life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: no other prior malignancy within the past 3 years except the following: adequately treated basal cell or squamous cell skin cancer carcinoma in situ of the cervix not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics endocrine therapy: not specified radiotherapy: see disease characteristics surgery: not specified

Keywords: limited stage small cell lung cancer extensive stage small cell lung cancer
to determine the feasibility of a fidaxomicin study in neonates and to assess c. difficile (clostridium difficile) involvement in the pathogenesis

Conditions: Clostridium Difficile

Summary: the objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. the incidence and clinical aspects of clostridium difficile infection (cdi) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.


Eligibility criteria:
inclusion criteria: * subject is suffering from diarrhea or other signs or symptoms consistent with cdad (as described in section 5.2.3) * presence of either toxin a or b (or both) of c. difficile in the stool within 24 hours prior to enrollment using the c. difficile quik chek complete® diagnostic test, provided by the sponsor exclusion criteria: subject will be excluded from participation if any of the following apply: * preterm neonates * negative c. difficile toxin test

Keywords: cdad neonates clostridium difficile
lanadelumab in bradykinin angioedema

Conditions: Angioedema

Summary: a multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema

the bradykinin-angioedema (ae-bk) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening. the clinical symptoms depend on accumulation of bradykinin (bk), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. bk formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (hk). lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing bk production; it represents an attractive therapeutic strategy for bk-ae prophylaxis. the aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved hk and the immunogenicity of the lanadelumab.

Eligibility criteria:
inclusion criteria: * male/female \>18 years old * patient with hereditary or acquired angioedema * patient treated by lanadelumab * patient whose the biological explorations have been carried out or will be carried out at laboratory of immunology of chuga * informed consent is obtained from the participant exclusion criteria: * absence of biological material at t0 and m3 (stored for routine analysis) * person under guardianship or curatorship * female who is pregnant, nursing

Keywords: kallikrein, kininogen, bradykinin, lanadelumab
addition of dydrogesterone to the luteal phase support after fresh embryo transfer

Conditions: Infertility; IVF

Summary: randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.

in the context of ivf treatment, it's a standard of care to use progesterone for endometrial synchronization and for luteal phase support after embryos transfer and until week 9-12 of pregnancy. in israel, as in most european countries, vaginal insert of micronised vaginal progesterone (mvp) is mostly prescribed. dydrogesterone is a potent active progesterone receptor agonist that is well tolerated, orally administered and is considered to be sufficiently safe during pregnancy. based on recent publications, single oral dydrogesterone treatment seems to be a good option in clinical practice for luteal phase support in ivf cycles with fresh embryos transfer. but, until now, there is no publication evaluating the effectiveness of an addition of dydrogesterone to the standard of care. the aim of the study is to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer. the trial is a randomized controlled study, open label. participants will receive either standard treatment with an addition of oral 10mg dydrogesterone (duphaston) 2 times daily or the standard treatment without dydrogesterone, starting on the day of fresh embryos transfer until 10 weeks of gestation or until pregnancy test is negative. study participation will be proposed to every woman going through fresh embryos transfer in laniado ivf unit, who meets the inclusion/exclusion criteria. the investigators aim to include 150 patients in each arm of the study, during 2 years.

Eligibility criteria:
inclusion criteria: * patients with a documented history of infertility who underwent ivf with or without icsi, going through embryos transfer (having in the past up to 2 previous embryos transfer) and who gave written informed consent. * body mass index ≥18 to ≤35 kg/m2 * lh, prolactin (prl), testosterone and thyroid-stimulating hormone (tsh) within normal clinical limits or not considered clinically significant within 1 year prior to or at screening * normal transvaginal ultrasound at screening (or within 14 days prior to screening) * planning a transfer of 1 or 2 fresh embryos. exclusion criteria: * previous participation in this trial * subjects with \>2 unsuccessful ivf attempts * evidence of head, ear, eye, nose, throat, cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine or neurologic/psychiatric disorders; * recent major surgery (within 3 months); * current or recent substance abuse, including that of alcohol and tobacco; * history of chemotherapy; * history of recurrent pregnancy loss (≥3 previous miscarriages)
partnerships to improve lifestyle interventions (pili) 'ohana dissemination project partners in care

Conditions: Type 2 Diabetes

Summary: the 3-month face-to-face partners in care intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. the intervention involves 12 weekly, group lessons with each lesson lasting about 1 and 1/2 hours. individuals with a hemoglobin a1c (hba1c; average blood sugar levels) greater than or equal to 7% will be recruited for the study because they represent the most at-risk for diabetes-related complications. over a 3-year accrual period, the community partners will recruit and enroll 150 eligible nhs and pps, as well as deliver and evaluate the intervention in their respective community settings. the primary outcomes of our study are hemoglobin a1c and self-reported diabetes specific quality of life. secondary outcomes are cholesterol levels (including hdl, ldl, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.


Eligibility criteria:
inclusion criteria: 1. adults age \>18 years of age, 2. english-speaking, 3. physician-diagnosed type 2 diabetes, and 4. baseline hemoglobin a1c \>7%. exclusion criteria: 1. survival less than 6 months, 2. planning to move out of the community during the intervention study period, 3. pregnancy, 4. any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).
early fast-track versus standard care for persons with hiv initiating tld

Conditions: HIV-1-infection

Summary: this study will evaluate the clinical efficacy of using earlier fast-track services compared to the standard of care in a clinical setting to improve retention in care and virologic suppression for patients who are initiating a dolutegravir-based antiretroviral therapy regimen.

with current approaches to hiv care, patients generally do not qualify for expedited services until they have been in care for 6 to 12 months. once they have achieved an undetectable viral load and/or high adherence, patients qualify for expedited services with fewer clinic visits. the problem with this approach is that it's time-intensive early in art care, when attrition rates are highest. a potential solution to this problem is to provide earlier fast-track care for patients on dolutegravir-based regimens with viral suppression. this strategy is feasible due to the high potency and rapid declines in viral load with dolutegravir-based regimens. we will compare a strategy of early fast-track care (8 to 12 weeks, for patients with viral suppression) versus standard initiation of fast-track care (after 6 months in care, with viral suppression). all participants will receive the same art regimen, the combination regimen of tenofovir disoproxil fumarate-lamivudine-dolutegravir.

Eligibility criteria:
inclusion criteria: * documentation of positive hiv status (test conducted at gheskio) * age ≥18 years of age * eligible for tld regimen, according to haitian ministry of health guidelines * initiate art within 3 days prior to enrollment * lives in port-au-prince metropolitan area * ability and willingness to give written informed consent * use of reliable contraception (for women of childbearing potential); * physician-confirmed who stage 1 or 2 disease exclusion criteria: * not art-naïve (history of art for any duration in the past) * world health organization stage 3 or 4 disease; * pregnancy or breastfeeding at the screening visit; * planning to become pregnant during the study period; * active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician; * creatinine clearance (crcl) \<50 within 1 month prior to study entry; * alt and/or ast\> 5x upper limit of normal (uln) within 1 month prior to study entry; * planning to transfer care to another clinic during the study period

Keywords: hiv antiretroviral therapy differentiated care expedited services