Kornimate/medical-research-clean huggingface dataset:
healthy lifestyle program: a novel group-based training

Conditions: Obesity

Summary: the healthy lifestyle program involves twelve, 2-hour seminars during which participants will learn how to build healthy behaviors through a combination of individual and group exercises. participants will use lessons from the seminars to pursue health goals and learn the basics of physical fitness, nutrition, sleep \& recovery, stress management, and weight management for optimal health. throughout the program, participants will be supported by a behavior coach along with dedicated fitness training, dietary strategy, and stress management support. as part of this next installment of the program, we are conducting a study of the healthy lifestyle program to capture outcome data, including weight/bmi, blood pressure, hemoglobin a1c, and lipid profile.


Eligibility criteria:
inclusion criteria: * preferential access to the hlp is provided folks who live in the neighborhoods of roxbury, dorchester, and mattapan. however, this is certainly not exclusive and we continue to have participants from all around the greater boston area, especially now that the program is being delivered virtually. exclusion criteria: * there are no groups of people who are excluded from participating in the program, except for the specified by the age cut offs.
lifestyle intervention on patients with overweight or obesity

Conditions: Obesity; Physical Activity; Eating Behavior; Therapeutic Alliance

Summary: this study aims to analyze the effects of a 3-month self-applied online program, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with obesity. participants will be recruited by 8 doctors from 6 public health centers. these patients will be randomized allocated into two interventional groups: the experimental group will receive audiovisual instructions from their specialist doctor, and the control group from a doctor outside the patient. assessment will include sociodemographic variables, body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the mediterranean diet, therapeutic alliance, and health-related quality of life. the randomization process will be stratified according to bmi, therapeutic alliance, age, and sex.

obesity or being overweight, even other associated comorbidities, involve a worrying public health problem. the evidence shows that healthy eating and regular physical exercise, monitored by different means (internet, face to face, exercise diaries), play an important prevention role to maintain health while ageing. in this way, information and communication technologies (icts) have been demonstrated as a useful tool to promote health, working on barriers at the same time, such as low motivation and difficulties maintaining regular exercise and/or healthy eating habits. icts also allows to reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions. therefore, this study aims to analyze the effects of a 3-month self-applied online program, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with obesity. participants will be recruited by 8 doctors from 6 public health centers. these patients will be randomized allocated into two interventional groups: the experimental group will receive audiovisual instructions from their specialist doctor, and the control group from a doctor outside the patient. assessment will include sociodemographic variables, body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the mediterranean diet, therapeutic alliance, and health-related quality of life. the randomization process will be stratified according to bmi, therapeutic alliance, age, and sex.

Eligibility criteria:
inclusion criteria: * overweight or grade i obesity (bmi \> 25 and \< 35). exclusion criteria: * no access to the internet or a smartphone. * not having visited their doctor at least once in the last 2 years. * meeting dsm-iv-tr criteria for an eating disorder. * having a diagnosed serious psychological disorder (psychosis, bipolar disorder, major depressive disorder, substance abuse disorder, etc.). * having any disability that prevents or hinders exercise and physical activity. * receiving any weight loss treatment at another center.
evaluation of a nutraceutical for endometriosis pain relief

Conditions: Endometriosis

Summary: based on the ehp-30 questionnaire, the pain score and general well-being of all patients will be assessed with and without taking a specialized nutraceutical. these patients will be taking continuous oral contraception, for 3 months before inclusion till at least end of the study or not taking any oral contraception at all during the study due to contraindication(s).


Eligibility criteria:
inclusion criteria: * confirmed endometriosis and/or positive nmr * 18-49y * mean pain score \>6 on the assessment of pelvic pain (visual analogue scale) * not eligible for surgery in the coming 3 months or had surgery \>3 months before inclusion in the study * \>3 months intake of continue oral contraception (oestrogen/progesterone) before inclusion or no intake of oral contraception due to contraindication * has given voluntary, written, informed consent to participate in the study. exclusion criteria: * planned surgery during study * \<3 month intake of continue oral contraception (oestrogen/progesterone) before inclusion * chronic inflammatory disease (chron's disease, rheumatism,..) * pregnancy * bariatric surgery * malabsorption issues * allergy or hypersensitivity to the study product: * fish and products thereof: fish oil * soybeans and products thereof * alcohol or substance abuse * start of gonadorelin analogue (ex. busereline, gosereline, triptoreline) therapy in the past 6 months * intake of other food supplements, including omega 3 and omega 6 * any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
emapalumab efficacy in children with primary hemophagocytic lymphohistiocytosis

Conditions: Primary Hemophagocytic Lymphohistiocytosis

Summary: the goal of this retrospective study is to assess efficacy and safety of emapalumab prescribed for the treatment in children with refractory from of phlh.

primary hemophagocytic lymphohistiocytosis (phlh) encompasses a group of genetically determined disorders, characterized by severe, often fulminant systemic inflammation, cytopenia and multiple organ involvement. the disease manifests predominantly in the early childhood, has high mortality rate and in most cases requires hematopoietic stem cell transplantation (hsct) as the only currently available curative option. yet, hsct outcomes are dependent on the state of remission of the underlying systemic inflammation and infections complications, as well as organ damage due to the side effects of the chemotherapeutic drugs received prior to it. for years the gold standard of hlh treatment has been the dexamethasone and etoposide-based hlh-2004 protocol, yet it failed to uniformly control the disease. an alternative regiment combining antithymocyte globulin and corticosteroids demonstrated good results but barely improved survival. also, no universally accepted treatment exists for relapsed or refractory hemophagocytic lymphohistiocytosis. advances in availability of biologic treatments open up new possibilities of hlh therapy, with several targets proposed in recent years. interleukin 6 inhibitor tocilizumab, interleukin 1 inhibitor anakinra, janus-kinase inhibitor (jakinib) ruxolititnib have been used for hlh treatment, with variable results. mounting evidence provides support for the pivotal pathogenic role of interferon-γ (ifng) in hemophagocytic lymphohistiocytosis. emapalumab is a fully human igg1 anti-interferon-γ monoclonal antibody that binds free and receptor-bound interferon-γ and inhibits its biologic activity. the data accumulated from the phase ii/iii clinical trial and reports of the small groups of patients demonstrate its efficacy in phll. the study will collect and analyze information of the effectiveness and safety of emapalumab treatment that was previously prescribed in a cohort of seven pediatric patients with phlh. criteria for inclusion in the study were: 1. age from 0 to 18 y. 2. the diagnosis of phlh ( established according to the histiocytic society criteria). 3. treatment with empalumab for at least 2 weeks 4. signed informed consent for participation in the study exclusion criteria - not applicable.

Eligibility criteria:
inclusion criteria: criteria for inclusion in the study were: 1. age from 0 to 18 y. 2. the diagnosis of phlh ( established according to the histiocytic society criteria). 3. treatment with empalumab for at least 2 weeks 4. signed informed consent for participation in the study exclusion criteria: not applicable. signed informed consent for participation in the study

Keywords: primary hemophagocytic lymphohistiocytosis children treatment emapalumab
haufen diagnostic biomarkers of bk renal disease

Conditions: Polyoma Virus Nephropathy

Summary: to prospectively test whether the detection of three-dimensional, cast-like polyomavirus aggregates, termed haufen, in voided urine samples can serve as an accurate biomarker of intra-renal disease, i.e. polyoma-bk-virus nephropathy (pvn). we want to correlate the detection of 'haufen' with histologic findings made in renal biopsies as well as signs of polyomavirus activation, i.e. viremia and viruria. the prospective study is designed to further validate our retrospective findings (manuscript in press, j am soc nephrology) and more specifically to correlate 'haufen' shedding with the histologically confirmed course of pvn.


Eligibility criteria:
inclusion criteria: * age 18 or older * recipient of renal transplant * positive for polyoma virus * haufen cells present in urine * positive for polyoma virus nephropathy exclusion criteria: * anyone who does not meet the inclusion criteria
memory flexibility training for depression

Conditions: Major Depressive Disorder

Summary: our collection of memories for personal experiences plays an important role in shaping our sense of who we are as people. these memories, termed autobiographical memories, can also be helpful in social situations, for sharing the details of our experiences with other people, reminiscing about pleasant times and solving problems by remembering what has and hasn't worked in the past. different types of autobiographical memory are helpful to us depending on the particular situation the investigators are in at the time. recent research has shown that experiencing depressed mood can affect how we relate to our autobiographical memories, so that instead of providing a rich source of personal information in a helpful and flexible way, the types of memories that come to mind are more narrowly focused on difficult or negative experiences. this can cause low mood to persist over time. the purpose of this study is to test a newly-developed therapeutic training package for depressed mood (memflex), designed to encourage helpful and flexible ways of relating to autobiographical memories. the memflex programme consists of a one-to-one orientation session with the researcher to introduce the training package, followed by a workbook that is completed at home.


Eligibility criteria:
inclusion criteria: * currently experiencing major depressive episode, indexed on the structured clinical interview for the dsm-iv (scid; first et al., 1996). * score of 13 or above on the beck depression inventory (beck et al., 1996) exclusion criteria: * scid assessment indicates they are experiencing another mood disorder, psychosis, current alcohol or substance dependence/abuse. * diagnosed axis ii disorder or brain injury (assessed by participant report)

Keywords: memory flexibility
bioequivalency study of ramipril 10 mg capsules under fasting conditions

Conditions: Hypertension

Summary: the objective of this study was to prove the bioequivalence of ramipril 10 mg capsules under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. treatment with known enzyme altering drugs. history of allergic or adverse response to ramipril or any comparable or similar product.
predicting factors for mortality in congenital heart disease patients after shunt procedure in developing country.

Conditions: Cyanotic Congenital Heart Disease

Summary: blalock taussig (bt) is a palliative procedure that preserves blood circulation to the lungs and alleviates cyanosis in patients with congenital heart diseases and reduced pulmonary blood flow. bt shunt remains a routinely performed procedure in developing countries before definitive surgery. however, evidence on predictors factors of mortality after this procedure is still scarce in indonesia.


Eligibility criteria:
inclusion criteria: * all chd pediatric patients with a previous history of bt shunt procedure. exclusion criteria: * pediatric patients with incomplete medical records
ankle exosuit training in the clinic to community community

Conditions: Stroke

Summary: this study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. the exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. we will determine the effect of training parameters of intensity, repetition, and gait quality which are all key parameters associated with experience-dependent neuroplasticity. the other objective is to determine the effect of this intervention on community walking activity, walking speed, walking distance, and locomotor mechanics and energetics.


Eligibility criteria:
inclusion criteria: * age 18 - 80 years old * stroke event occurred at least 6 months ago * observable gait deficits * able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support) * passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot) * resting heart rate between 40 - 100 bpm, inclusive * resting blood pressure between 90/60 and 170/90 mmhg, inclusive * medical clearance by a physician exclusion criteria: * score of \>1 on question 1b and \>0 on question 1c on the nih stroke scale * inability to communicate with investigators * neglect or hemianopia * unexplained dizziness in the last 6 months * pressure ulcers or skin wounds located at human-device interface sites * history of significant peripheral artery disease (pad) * unresolved deep vein thrombosis (dvt) * uncontrolled or untreated hypertension * significant paretic ankle contractures (plantarflexion \> 5°) * psychiatric or cognitive impairments that may interfere with proper operation of the device

Keywords: exoskeleton ambulation robotics stroke walking
efficacy and safety of paroxetine daily doses of 15 mg and 20 mg in the treatment of premature ejaculation

Conditions: Premature Ejaculation

Summary: as study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg for the treatment of premature ejaculation

randomized, double blind, placebo controlled, prospective and parallel trial. men with premature ejaculation using the diagnostic and statistical manual of mental disorders, fourth edition, text revision criteria for at least 6 months, with an intravaginal ejaculatory latency time (ielt) ≤ 3 minutes. three treatments are to be compared: placebo, 15 mg or 20 mg paroxetine for 12 weeks.

Eligibility criteria:
inclusion criteria: * men between 20 and 70 years of age * with a stable relationship with a female partner * with the intention to continue with the same partner for the duration of the study * with diagnosis of premature ejaculation according to the criteria established in the diagnostic and statistical manual of mental disorders iv edition, revised text for at least 6 months before inclusion * with an intravaginal ejaculatory latency time (ielt) ≤ 3 minutes in at least 75 % of a minimum of three sexual encounters, elapsing between them at least 18 hours during the selection phase of the study * with agreement to avoid pregnancy or planned surgery during the study, * female participants should not be pregnant at the inclusion * both male and female partners had to agree to participate and to sign the informed consent form exclusion criteria: * any medical or surgical condition that could be associated with the initiation of premature ejaculation for secondary pe * history of myocardial infarction or stroke in the last 6 months * hemorrhagic disorder, hepatitis b or c, hiv infection, penile implant surgery at any time * alcohol or drug abuse in the last 2 years * any medical or psychiatric condition that could interfere with study procedures and evaluations * uncontrolled diabetes * hypotension (defined as systolic/diastolic blood pressure \< 90/50 mm hg) * uncontrolled hypertension * diagnosis of erectile dysfunction or a score ≤ 21 in the erectile function domain of the international index of erectile function (iief) at inclusion * treatment with any investigational drug in the last month or 5 times the half life of the drug * use of medications that could enhance the effect of paroxetine, * known intolerance to selective serotonin recapture inhibitors * hypoactive sexual desire not caused by pe * sexual dysfunction in the female partner that could interfere with participation * any other significant clinical conditions that could interfere with study procedures * employees of research sites and relatives of researchers

Keywords: premature ejaculation paroxetine daily treatment
stem cell transplant w/laronidase for hurler

Conditions: Mucopolysaccharidosis I; Hurler Syndrome

Summary: the investigators hypothesize that weekly infusions of laronidase ert for 10-12 weeks prior to transplant and 8 weeks following transplant will result in a reduction of glycosaminoglycans (gag) burden that is associated with decreased complications following transplant.

subjects will receive laronidase once a week intravenously for 10-12 weeks prior to transplant and for approximately 8 weeks after transplant. laronidase will be given by intravenous infusion (iv) through a catheter and from there to your child's body's cells and organs to break down the glycosaminoglycans (gag) buildup. prior to starting ert, subjects will have a complete physical examination, which includes a complete assessment of your child's airway and lungs. in addition to standard treatment evaluations and tests, which are done prior to hematopoietic stem cell transplant (hsct), subjects will have the following tests: an additional teaspoon of blood for a baseline test for serum antibodies against laronidase, before and after the fourth dose of laronidase, the investigators will collect 2 teaspoons of blood for an alpha-l-iduronidase enzyme level; to watch for side effects to laronidase and the development of antibodies to laronidase, approximately 2 teaspoons of blood will be collected every 3 weeks while the subject is receiving laronidase ert.

Eligibility criteria:
inclusion criteria: * patients with the diagnosis of mucopolysaccharidosis type ih (mps i, hurler syndrome) who are candidates for first hematopoietic stem cell transplant (hsct) according to a university of minnesota myeloablative hsct protocol. exclusion criteria: * not being considered for university of minnesota myeloablative hsct protocol. * previous administration of laronidase enzyme * second or subsequent hsct.

Keywords: laronidase ert stem cell transplant storage disease inborn errors of metabolism hurler syndrome glycosaminoglycans enzyme replacement
detection of coronary artery disease with micro electro-mechanical sensors

Conditions: Coronary Artery Disease

Summary: this study aims to validate the sensor data of gyroscope and accelerometer in detection of hemodynamically significant cad.

heart diseases are the most common cause of morbidity and mortality in the western world. coronary artery disease (cad) alone is estimated to affect 110 million people globally and resulted in 8.9 million deaths in 2015. a hallmark phenomenon in the development of cad is the formation of arterial stenoses eventually limiting the arterial circulation. myocardial ischemia caused by the stenoses may present symptoms considered typical, i.e, angina pectoris chest pain, but the symptoms may vary up to an asymptomatic state. estimating the pre-test likelihood of angiographically significant cad (≥50% diameter stenotic cad) is a fundamental component in the initial evaluation of symptomatic patients presenting with suspected cad. this determination directly influences subsequent decisions for noninvasive diagnostic testing and treatment. however, studies have shown a relatively low prevalence of either ischemia or obstructive cad on noninvasive imaging and invasive angiography (ia) in this population. therefore, additional methods are needed to improve patient selection for such testing. mechanocardiography (mcg) assesses the condition of the heart by measuring the mechanical activity (cardiac muscle motion) of the heart from the surface of thorax. mcg can be measured with accelerometer and gyroscope which react to recoil and vibration caused my cardiac contraction. this study aims to validate how the gyroscope and accelerometer derived parameters can identify patients with hemodynamically significant cad in combined contrast computed tomography (ct) coronary angiography and positron emission tomography (pet) perfusion imaging in combination of high-sensitive troponin testing. the performance of different mcg algorithms will be tested offline as a head-to-head comparison with medical history, cardiovascular events, high-sensitive troponin values, coronary computed tomography angiography (ccta) and pet scan results.

Eligibility criteria:
inclusion criteria: * age \> 18 years * patients visiting hospital for suspected cad and undergoing ccta * signed informed consent as an acceptance to participate to the trial exclusion criteria: * informed consent not signed
safety, pharmacokinetics and pharmacodynamics of bps804 in osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: this is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of bps804 in adults with osteogenesis imperfecta (oi). pharmacodynamic effect will be determined by serological biomarkers and radiologic assessments. in addition, tolerability and pharmacokinetics (pk) will be evaluated.

this study was previously posted by mereo biopharma and was transferred to ultragenyx in february 2021.

Eligibility criteria:
inclusion criteria: * osteogenesis imperfecta * two or more previous fractures * bone mineral density z-score of ≤ -1.0 and \> -4.0 exclusion criteria: * open epiphyses * fracture within last 2 weeks * treatment with bisphosphonates/teriparatide (last 6 months) * surgery within last year other protocol-defined inclusion/exclusion criteria may apply

Keywords: brittle bone disease inherited connective tissue disorder fracture