Kornimate/medical-research-clean huggingface dataset:
prevalence of iodine deficiency in remote communities of haiti

Conditions: Iodine Deficiency

Summary: haiti is one of the few remaining countries that is at risk of iodine deficiency disorders. in the 2018 survey, iodized salt was found in \<20% of households and iodine excretion from non-pregnant and pregnant women suggested inadequate intakes, with those in remote inland settings most at risk. the haiti salt program (hsp) was established in 2006 at the university of notre dame, us (und). using a self-sustaining business model that protects the livelihoods of all who work within it, the hsp has a goal of supplying fortified salt to combat idd and lymphatic filariasis. hsp purchases salt from local small producers for processing in a local factory equipped with robust, standardized and controlled facilities that iodizes the salt under correct conditions, ready for fair resale to the consumer. the salt is currently distributed in the west department, though a country-wide roll-out is envisaged. this initiative has the potential to accelerate optimization of population iodine intake across haiti and through idd prevention, positively contributing to the development of the country. data on iodine status and intake of native iodine-rich foods, iodized salt and other iodine-fortified foods e.g., bouillon cubes in haiti, are sparse, particularly from rural and remote locations. an update on the situation in such remote areas in haiti is trequired, to inform and leverage the development and implementation of iodized salt policy in the region. the specific objective of this study is to assess the iodine status of two representative population subgroups, namely school-age children and women of reproductive age, in a remote region of the central plateau of haiti. we hypothesize that the muic will indicate population iodine insufficiency in both of these population groups.


Eligibility criteria:
we will recruit school age children (male and female, aged 9-13 years) and women of reproductive age (aged 18-44 years). the inclusion criteria for all subjects will be: 1. residence within the study area for ≥12 months; 2. general good health as assessed by no reported treatment for chronic disease; 3. no known history of goiter or other thyroid disease; 4. no exposure to iodine containing contrast agent or medication within the last year; 5. women of reproductive age should not currently be pregnant or be breastfeeding, assessed by asking the women.
the impact of lifestyle on mental health among young men in the gilgel gibe field research center, ethiopia: pilot study

Conditions: Common Mental Disorders (CMD); Psychotic Symptoms

Summary: researchers of the three collaborating universities implement a pilot observational study in "gilgel gibe field research center", a health and demographic surveillance system run by the jimma university, ethiopia. in this setting, the investigators plan to study risk factors in young men for the development of common mental disorders and psychotic symptoms and the stability of distinct symptoms of mental disorders in the community. the investigators will explore in particular the impact of lifestyle on mental health in young men, including the traditional habit of chewing khat leaves, which contain amphetamine-like cathinone. furthermore, the investigators want to demonstrate the reliability and validity of assessments performed by trained local interviewers.


Eligibility criteria:
inclusion criteria: * male, age 18 - 30, permanent residents in gilgel gibe exclusion criteria: * prior existing severe mental health problems
pain map dk: a prospective cohort study of pain treatment in 500 hip arthroplasty patients at different danish hospitals

Conditions: Postoperative Pain

Summary: this is a prospective observational cohorte study. the aim is to investigate actual pain treatment and outcomes in a large population of total hip arthroplasty patients at 5 different hospitals in denmark.


Eligibility criteria:
inclusion criteria: * primary planned total hip arthroplasty, able to understand and speak english or danish. exclusion criteria: * patients not able to cooperate, patients with alcohol or drug abuse

Keywords: postoperative pain treatment
automated detection of brain metastases on mri

Conditions: Brain Metastases

Summary: this reader study aims at assessing whether the radiologist aided with ai software has at least a non-inferior performance than without ai assistance in detecting brain metastases. 200 retrospective mri images will be included in the study with 100 positive and 100 negative exams. assessment will be completed by 12 readers with varying level of experience. this is a retrospective multiple-reader multiple-case (mrmc) randomised study.


Eligibility criteria:
inclusion criteria: * subjects older than 18 years with a known or possible primary extracranial cancer who undergo mri for diagnosis, treatment planning or follow-up of brain metastases. exclusion criteria: * subjects with primary intracranial tumor(s), with more than 10 brain metastases, with meningeal metastases, with radiation necrosis, or post brain surgery
a cross sectional disease/condition focused observational study on chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to establish the prevalence of comorbidities in italian patients with chronic bronchitis with at least 2 exacerbations per year, and to document the appropriateness of instrumental diagnostic tests, such as spirometry of these patients.

this is an observational study so participants will only take medication that is presently prescribed by their regular healthcare provider. no additional study medication will be administered. this study will enroll patients who have been previously diagnosed with copd. this study will look at the medical history and other diseases that have been diagnosed in people who also have copd. the study will enroll approximately 3000 patients. this multi-centre trial will be conducted in italy. the overall time to participate in this study is at a single, regularly scheduled visit at the pulmonologists office. there will not be any follow up assessments.

Eligibility criteria:
inclusion criteria: 1. age 45-85, of either gender. 2. signed informed consent. 3. known copd documented by spirometric exams showing fixed non reversible respiratory obstruction. 4. forced expired volume measured after 1 second expiration (fev-1) \< 50% in a previous test (no time limits). 5. symptoms of chronic bronchitis : chronic productive cough for 3 months at least in each of the 2 years prior to the index visits. 6. on treatment of bronchodilators (no restrictions) for the last 12 months at least. 7. history of at least 2 exacerbations (moderate/severe) in the last 12 months prior to index visit. exclusion criteria: * none

Keywords: drug therapy
a single group study to evaluate the effects of a myo-inositol and d-chiro inositol supplement on symptoms associated with polycystic ovary syndrome and hormone imbalance

Conditions: Polycystic Ovary Syndrome; Hormone Imbalance

Summary: this is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the optify myo inositol and d-chiro inositol plus folate and vitamin d supplement per day. questionnaires will be completed at baseline, week 4, week 8 and week 12. participants will also provide a waist circumference measurement at baseline and week 12.


Eligibility criteria:
inclusion criteria: * women aged between 18 - 55 * bmi less than 35 * self-reported symptoms of pcos like irregular periods, excessive hair growth, weight gain, oily skin, or acne * self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy * self-reported concerns with hormonal skin issues * has access to a tape measure for waist measurement * generally healthy - don't live with any uncontrolled chronic disease exclusion criteria: * anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * anyone with known severe allergic reactions * anyone who is pregnant or breastfeeding * unwilling to follow the study protocol
epicardial stimulation of the cardiac autonomic nervous system

Conditions: Cardiac Insufficiency

Summary: the objective of the epicans study is to evaluate the technique of stimulation of the cardiac autonomic nervous system (snac) directly at the epicardial level in humans during heart surgery. proof of concept study

isolated stimulation of the parasympathetic system induces a protective effect on long-term cardiac remodeling, but at the cost of inhibiting the sympathetic system. the role of the sympathetic system is to increase cardiac output in cases of acute heart failure. electrical stimulation of the cardiac plexus directly at the level of the heart allows simultaneous stimulation of the sympathetic and parasympathetic systems, whose complementary and not automatically antagonistic role is now recognized. thus, direct stimulation of the plexus would optimize cardiac function in the short and long term by instantly improving cardiac output and decreasing pulmonary resistance as described in dogs by kobayashi et al. the objective of the epicans study is to evaluate this technique in humans during cardiac surgery.

Eligibility criteria:
inclusion criteria: * scheduled for elective cardiac surgery for valvular or coronary surgery * having received written and oral information about the protocol and having signed a written informed consent * affiliated or beneficiary of a social security plan exclusion criteria: * patient with an indication for cardiac surgery: * urgent or semi-urgent * aortic surgery * heart transplantation * mechanical circulatory assistance * patients who have already undergone cardiac surgery * adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors, persons unable to express their consent, persons hospitalized for a different reason

Keywords: cardiac plexus electrical stimulation
the dutch strider (sildenafil therapy in dismal prognosis early-onset fetal growth restriction)

Conditions: Fetal Growth Restriction

Summary: rationale: severe, early-onset fetal growth restriction (fgr) due to placental insufficiency is associated with a high risk of perinatal morbidity with long-lasting sequelae and mortality. placental insufficiency is the result of abnormal formation and function of the placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental) arteries. there is currently no therapy available with demonstrated effectiveness. evidence suggests sildenafil citrate improves uteroplacental blood flow, growth, and meaningful outcomes. objective: to evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival. study design: multicenter nationwide randomized placebo-controlled clinical trial. study population: women with a singleton pregnancy between 20 and 30 weeks with severe fetal growth restriction of likely placental origin, and with estimated significant likelihood of perinatal death. intervention: sildenafil 25mg or placebo tablet orally three times daily. main study parameters/endpoints: perinatal healthy survival, i.e. survival without severe neonatal morbidity at term age. nature and extent of the burden and risks associated with participation, benefit and group relatedness: taking tablets three times daily. no additional ultrasounds, other than standard clinical protocol, one extra blood sample at inclusion. no risks anticipated, unexpected medication-associated risks can't be excluded on beforehand.


Eligibility criteria:
inclusion criteria: inclusion criteria ((i or ii) and iii): * at 20+0-27+6 weeks: an ultrasound measurement of the fetal abdominal circumference (ac) \<3rd percentile for gestational age or an ultrasound estimate of fetal weight (efw) \<5th percentile or * at 28+0-29+6 weeks: an ultrasound estimate of fetal weight (efw) \<700 grams using hadlock c formula and * likely placental origin defined by (a and/or b and/or c and/or d) * the presence of uterine artery notching * abnormal flow velocity patterns of the umbilical artery or middle cerebral artery * maternal hypertensive disorders * low plgf in point-of-care assessment exclusion criteria: * plan to terminate pregnancy for maternal or fetal indication within days * known multiple pregnancy * identified congenital anomalies or congenital infection * maternal age at eligibility \<18 years * cocaine use * current use of sildenafil * current use of cyp3a5 inhibitors: amiodaron, azitromycine, ciclosporine, claritromycine, diltiazem, erytromycine, fluconazol, itraconazol, ketoconazol, verapamil, voriconazol. * recent myocardial infarction or stroke

Keywords: fetal growth restriction sildenafil
the effects of medical clowning on blood pressure and pulse rate of patients undergoing cataract surgery under local anesthesia

Conditions: Blood Pressure; Heart Rate

Summary: cataract surgery is the most prevalent surgical procedure. since most candidates are elderly patients, hypertension is common among these patients. preoperative anxiety and tension may cause elevation of patient's heart rate and blood pressure and thus expose them to serious potential complications such as stroke and myocardial infarction. medical clowns are known to reduce preoperative anxiety of both children and their parents. it is possible therefore that medical clown may have such a beneficial effect also on patients scheduled for cataract surgery under local anesthesia.


Eligibility criteria:
inclusion criteria: * patients undergoing an elective, ambulatory cataract surgery (phacoemulsification technique) * surgery planned to be performed under local anesthesia * age \> 40 years * patients signed an informed consent exclusion criteria: * hypertensive patients who did not take their prescribed medications on the day of surgery * uncontrolled hypertension during the month preceding the surgery * patients with systolic and diastolic bp values of \>190 and 100 mmhg respectively, measured 1hr prior to surgery * patients not suitable for surgery under local anesthesia * patients in whom the planned phacoemulsification technique was converted to either the ecce or icce technique * patients in whom an anterior vitrectomy had to be performed during surgery * patients treated regularly by anti-anxiety or analgetic treatment

Keywords: medical clowns cataract surgery blood pressure heart rate
outcomes of early laparoscopic cholecystectomy in cases of acute cholecystitis

Conditions: Acute Calculous Cholecystitis

Summary: laparoscopic cholecystectomy is the most common laparoscopic surgery performed in the world. the initial treatment of acute calculus cholecystitis includes git rest, intravenous fluid, correction of electrolyte imbalance from repeated vomiting, good analgesia, and intravenous antibiotics. following this treatment, patients with uncomplicated disease are managed on outpatient basis and are called for elective laparoscopic cholecystectomy after a period of 6-8 weeks. elective laparoscopic cholecystectomy has become the gold standard for treatment of symptomatic gallstones. however, in the early days, acute cholecystitis was a contraindication of laparoscopic cholecystectomy, and patients with acute cholecystitis were managed conservatively and discharged for re-admission in order to have elective surgery performed for the definitive treatment. early laparoscopic cholecystectomy, within 72 hours of presentation,has been advocated because of shorter hospital stay, decreased financial costs and reduced readmission rates. previously cited reasons against early laparoscopic cholecystectomy include the increased technical difficulties, increased risk of conversion to an open procedure (6-35 % in some studies) and increased risks of biliary complications such as bile leaks and common bile duct (cbd) injuries when operating on an inflamed gallbladder with edematous planes and distorted anatomy.


Eligibility criteria:
inclusion criteria: * any patient presented by acute cholecystitis fit for lap cholecystectomy . exclusion criteria: * patients unfit for laparoscopic surgery such as patients with significant medical illness (asagrade more 3), pancreatitis and common bile duct stones
a single-dose study in normal volunteers to assess the safety, tolerability and pharmacokinetics of stx107

Conditions: Fragile X Syndrome

Summary: the objectives of this study are to determine the safety and tolerability of single oral doses of stx107 and to determine basic pharmacokinetic (pk) parameters following single oral doses of stx107 when administered via an oral suspension


Eligibility criteria:
inclusion criteria: * normal, healthy males 18-50 years old, inclusive. * able to comprehend and willing to sign an informed consent form (icf). exclusion criteria: significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator).
cost-effectiveness of family based pediatric obesity treatment

Conditions: Weight Change; Quality of Life

Summary: to determine the cost effectiveness of treating the child alone and parent alone to traditional family-based method of obesity treatment. it is hypothesized that a family-based approach will be more cost effective, and will support the savings and effectiveness of treating multiple family members together.

research has shown that family-based treatment programs produce significant short and long-term decreases in weight relative to height. reductions in relative weight are observed for both parents and their children, with a significant relationship between parent and child relative weight changes. usual care for families with obesity is for the parent and child to be treated separately by their individual physicians, often with different types of treatment plans. this may be less efficacious for the parent and child than a family-based intervention in which the parent and child are treated together. the separate treatments may also be more expensive than concurrent treatment following the same treatment plan. there are many reasons to hypothesize that a family-based treatment will be more efficacious and more cost effective than other formats for treating families with multiple generations of obesity. if family members are treated together, they have the same treatment goals. they can learn to support each other, model positive behaviors, work together to change behaviors and modify the shared family environment. the simultaneous treatment of parents and children in a group format, which is how family-based treatments are administered, reduces the time therapists provide treatment in comparison to the usual format in which each parent and child would be seen individually. an important challenge for obesity treatment is to develop efficacious and cost-effective interventions to treat pediatric obesity. the goal of this study is to evaluate the efficacy and cost effectiveness over 12 month follow-up for 50 families with overweight parents and children randomized to family-based behavioral treatment in comparison to the treatment of the parents and children separately, by different therapists, which represent usual care for families with obese parents and children.

Eligibility criteria:
inclusion criteria: * overweight child and parent in each family exclusion criteria: * the parent and child must have no dietary or activity limitations that would preclude making the requested behavior changes; no current psychiatric problems and no history of eating disorders, including anorexia nervosa, bulimia nervosa or binge eating disorder. families with a first degree relative with any of the mentioned eating disorders will also be excluded. the participating child must be able to read at a 3rd grade level and demonstrate the ability to maintain diet and activity records in a simulated recording interview. both parent and child must be able to read the english language well enough to understand the consent and assent forms.

Keywords: weight cost effectiveness obesity family based behavioral treatment
a study to evaluate the persistence and immune response to a booster dose of menacwy

Conditions: Meningococcal Disease; Meningococcal Meningitis

Summary: the primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study v59p6 in which they received either novartis meningococcal (menacwy) conjugate vaccine or licensed polysaccharide men acwy vaccine (menomune®). the study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

persistence of antibody response at 5 years after one dose of menacwy or menomune

Eligibility criteria:
inclusion criteria: * healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination. * female subjects were to be negative for pregnancy exclusion criteria: * history of meningococcal disease * receipt of any meningococcal vaccine outside of parent study (v59p6) * serious, acute, or chronic illnesses including hiv infection/disease and any malignancy * receipt of any vaccine 14 days prior to the study, or expected through the duration of the study * any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study

Keywords: meningococcal acwy conjugate vaccine meningitis adolescents persistence