Kornimate/medical-research-clean huggingface dataset:
effect of feeding with nutrient dense formula in malnourished infants and children with congenital heart defects

Conditions: Congenital Heart Disease

Summary: infants with congenital heart disease (chd) are usually born with a normal weight but develop malnutrition over time, and about 20-50% of these children are usually malnourished. malnutrition in these patients is multifactorial. to compensate for the increased need for infants and children with chd, an increase in their caloric intake has been suggested. however, these patients may not be able to receive enough to meet the increased needs and catch-up growth. one of the suggested solutions in these patients to compensate for inadequate food intake is to increase the caloric density of milk or formula. for this purpose, the use of special formulas with higher calorie density or enrichment of normal formula or breast milk using special enrichment formula could be suggested. in the present study, the effect of increasing calorie intake by increasing the concentration of normal formula in comparison with formula with standard concentration on weight gain and other anthropometric indices of chd patients with malnutrition will be compared.


Eligibility criteria:
inclusion criteria: * infant and children 6 to 24 months with chd undergoing repair surgery * malnutrition (weight for age z score ≤ -1) exclusion criteria: * allergy to cow's milk protein * preterm infant or infant weighing less than 2500 grams at birth * children with chromosomal disease (down, turner)
a pilot randomized trial of video-based family therapy for depressed home visited mothers

Conditions: Perinatal Depression; Postpartum Depression; Family Conflict

Summary: depressed mothers (pregnant and post-delivery) make up a significant portion of maternal, infant, and early childhood home visiting (miechv) clients. home visited mothers often experience family conflict that precipitates or worsens their depressive symptoms. this study uses an effectiveness-implementation hybrid type 1 design with a pilot randomized trial to test the feasibility, acceptability, tolerability, safety, and preliminary effectiveness of an innovative family therapy intervention that uses technology to bypass barriers to increase access to treatment for this vulnerable population.


Eligibility criteria:
inclusion criteria: * mothers in any trimester of pregnancy through 18 months postpartum who are enrolled in home visiting at a participating agency; * fluent in english; * mother and her family member have at least an 8th grade education; * mothers with beck depression inventory-second edition scores of at least 20; * perceived hostility survey-adult raw scores of at least 16 for the adult mother and her adult family member; perceived hostility survey-child raw scores of at least 14 for the adolescent mother and her adolescent intimate partner; and * consistent internet access on their cell phones, tablets, or computer equipped with a microphone and camera. exclusion criteria: * suicidal ideation in the mother and/or her family member; * mothers with bipolar disorder symptoms; * psychotic symptoms in the mother and/or her family member; * mother is currently receiving individual therapy; * family is currently receiving family therapy; * mothers who have been taking an antidepressant for less than 2 months; and * families with domestic violence.
novel measure of social deficits in children

Conditions: Autism Spectrum Disorders; ADHD

Summary: autism spectrum disorders (asd) feature impairments in social interaction and communication. drug and behavioral treatments for asd are undergoing rapid development, yet our diagnostic tools are not suitable for efficacy assessment. the autism-diagnosis observational schedule (ados) is a clinical interview with the child and the gold standard for diagnosis. however, this test is subjective, course grained and costly, precluding repeated tests of the same child to assess treatment efficacy and large-scale control assessments of typically developing (td) children. for these reasons, the ados can impede imaging and genetic research. in light of these concerns, the oregon animation test for social reciprocity (oats) will be developed to evaluate distinct autistic behavioral phenotypes, including joint attention, empathy, imitation, and lack of narrative coherence. the main idea of oats is that animated characters and social scenarios are presented on a computer screen while the responses of the child are recorded by video camera, microphone, and eye-tracking equipment. animations are used to test each behavioral phenotype of autism. the long-term vision for oats is to evaluate behavioral and physiological responses of autistic children, including heart rate variability, pupil dilation, and eeg. our first objective is to use existing animations to build an oats "prototype" that discriminates autistic from normal children (aim 1). from these results, and use of a defined library of still frame posed images, we will design our own animation platform to assess differences between autistic and normal children (aim 2).

please see the brief summary above.

Eligibility criteria:
inclusion criteria: * 6-11 years of age with autism, * adhd, or typical exclusion criteria: * iq below 70.

Keywords: autism adhd attention deficit hyperactivity disorder behavioral assessment behavior
resolving psychological stress

Conditions: Post-Traumatic Stress Disorder; Alcohol Use Disorder

Summary: the investigators have developed a mobile app called resolving psychological stress (reps) to help alleviate symptoms of ptsd. the app will administer threat-related attention bias modification to individuals who have both a diagnostic and statistical manual of mental disorders v (dsm-v) diagnosis of ptsd (and meet at least one dsm-v criteria for threat sensitivity) and a dsm-v diagnosis of alcohol use disorder. the aims of the study are to explore both the feasibility and acceptability of the app with it's users, and to explore the efficacy of the app at alleviating ptsd severity.

posttraumatic stress disorder (ptsd) is a highly disabling disorder that affects approximately 30 million people in the united states. new low-cost and accessible treatments for ptsd are desperately needed. threat-related attention biases represent an important potential treatment target for ptsd. such attention biases predict risk for ptsd following trauma exposure, and are thought to maintain symptoms of ptsd and other anxiety disorders. research indicates that specific forms of computerized attention bias modification (abm) are effective in reducing attention bias for threat as well as anxiety in patients with diverse anxiety disorders. the investigators have developed a mobile "app" called reps (resolving psychological stress) to administer threat-related abm to patients with ptsd and alcohol use disorder and have tested it in a laboratory-based pilot study of 19 people with ptsd. preliminary data indicate that the app is highly acceptable to patients and that use of the app reduces attention bias for threat and ptsd symptom severity. the study aims are to examine the feasibility, acceptability and usability of app-based abm; and determine the efficacy of app-based abm in reducing attention bias and ptsd severity.

Eligibility criteria:
inclusion criteria: 1. must have current ptsd symptoms. 2. must drink alcohol. exclusion criteria: 1. very recent or current trauma or trauma exposure. 2. recent moderate or severe non-alcohol substance use disorder. 3. active suicidality. 4. lifetime history of schizophrenia or bipolar disorder i. 5. medical conditions including seizure disorders, neurological disorders, moderate or severe head injury, systemic illness affecting nervous system function, heart defect, or medically unstable injuries. 6. recent or planned change in psychotherapeutic treatment for ptsd or other psychiatric symptoms

Keywords: attention bias modification ptsd digital health alcohol use disorder
home-based physical trainings for reducing cardiovascular risk

Conditions: Metabolic Syndrome

Summary: prospective intervention study among metabolic syndrome patients, investigating the effects of 12 weeks home-based physical training programme with telemonitoring on the anthropometric parameters, the exercise tolerance and other cardio-metabolic risk factors of the metabolic syndrome.

prospective intervention study among metabolic syndrome patients, investigating the effects of 12 weeks home-based physical training programme with telemonitoring on the anthropometric and laboratory parameters, the exercise tolerance and other cardio-metabolic and other psycho-social (anxiety, depression, vital exhaustion , sleep disturbances) risk factors of the metabolic syndrome.

Eligibility criteria:
inclusion criteria: * voluntary patients aged between 25 and 70 years * low level of regular physical activity, less than 30 min./ week * basic it skills * 3 risk factors present out of the 5 metabolic risk factors from the followings: 1. waist circumference (wc) above 102 cm in men and above 88 cm in women 2. proved type 2 diabetes mellitus (t2dm) or fasting plasma glucose level above 5,6 mmol/l 3. treated hypertension or spontaneous blood pressure higher or equivalent than 130/ 85 mmhg 4. treated hypertriglyceridaemia or serum triglyceride level above 1,7 mmol/l 5. serum hdl cholesterol level under 1,03 mmol/l in men or 1,3 mmol/l in women exclusion criteria: * any upcoming planned invasive cardiological intervention * uncontrolled hypertension * type one diabetes mellitus (t1dm) * t2dm which needed more than 1 dose insulin per day * chronic heart failure * chronic renal failure * serious cognitive disfunction * lack of cooperation * any of known disease or condition that seriously affect the mental and legal capacity * any other conditions inhibiting regular physical trainings
a study to assess the safety and efficacy of levodopa-carbidopa intestinal gel (lcig) for the treatment of non-motor symptoms in patients with advanced parkinson's disease

Conditions: Advanced Parkinson's Disease

Summary: the primary objective of this study is to evaluate change in non-motor symptoms from baseline to week 12 as measured by the non-motor symptom scale total score.


Eligibility criteria:
inclusion criteria: * subject must have a diagnosis of idiopathic parkinson's disease (pd) according to the united kingdom parkinson's disease society (ukpds) brain bank criteria * demonstrate persistent motor fluctuations in spite of individually optimized treatment * subject must experience a minimum of 3 hours "off" time exclusion criteria: * subject's pd diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g., multiple system atrophy, progressive supranuclear palsy, diffuse lewy body disease, corticobasilar degeneration), or other neurodegenerative disease that might mimic the symptoms of pd. * subject has undergone neurosurgery for the treatment of parkinson's disease * subject for whom the placement of a peg-j tube for lcig treatment is contraindicated or is considered a high risk for the peg-j procedure according to the gastroenterology evaluation (e.g., pathological changes of the gastric wall, inability to bring the gastric wall and abdominal wall together, blood coagulation disorders, peritonitis, acute pancreatitis, paralytic ileus).

Keywords: safety and efficacy advanced parkinson's disease levodopa-carbidopa intestinal gel, carbidopa levodopa non-motor symptom scale
investigation of v520 in an hiv vaccine proof-of-concept study (v520-023)

Conditions: AIDS; HIV Infections

Summary: this study will test the safety and efficacy of an investigational human immunodeficiency virus (hiv) vaccine. efficacy will be measured by either prevention of hiv infection or control of hiv viral load in subjects who become hiv infected. on september 18, 2007 the protocol v520-023 dsmb (data \& safety monitoring board) reviewed data from a planned interim analysis. these data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted. participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.

no further treatment was given in v520-023, however participants were followed. v520-023 protocol ended earlier than originally planned per protocol and participants (hiv infected and uninfected) had the option of participating in an observational long term follow up protocol called v520-030/hvtn 504, which served as an extension of v520-023 and would continue through the end of 2009.

Eligibility criteria:
inclusion criteria: * healthy, hiv seronegative adults at high risk of acquiring hiv infection * cannot have previously received an investigational vaccine exclusion criteria: * in a monogamous relationship with an hiv-1 seronegative partner for \> 1 year * history of anaphylaxis and/or allergy to vaccine components, including tris buffer, mgcl2, and polysorbate 80 (tween) * received an immune globulin or blood derived products 3 months before injection with the first dose of vaccine/placebo or scheduled within 14 days after injection * previously vaccinated with a live virus vaccine within 30 days before injection with the first dose of vaccine or scheduled within 14 days after injection * previously vaccinated with an inactivated vaccine within 5 days before injection with the first dose of vaccine or scheduled within 14 days after injection * known history of immunodeficiency * history of malignancy (with some exceptions) * contraindication to intramuscular (im) injection such as anticoagulant therapy or thrombocytopenia * female subject who is pregnant or breast feeding, or expecting to conceive or donate eggs through week 30 of the study * male subject who is planning to impregnate or provide sperm donation through week 30 of the study * previously received an investigational hiv vaccine * has active drug or alcohol abuse or dependence that would interfere with adherence to study requirements, or endanger the subject's health while on the study * has a condition that might endanger the subject's health or interfere with the evaluation of the study objectives
comparative effects of wurn technique and mercier therapy in women with endometriosis

Conditions: Endometriosis

Summary: this project was a randomized controlled trial conducted to check the comparative effects of wurn technique and mercier therapy on dyspareunia, dysmenorrhea, and quality of life in women with endometriosis. the duration was 6 months, convenient sampling was done, subjects following eligibility criteria from dhq hospital narowal and thq hospital shakargarh were randomly assigned, a baseline assessment was done, group a participants were given baseline treatment along with wurn technique 2 sessions per week for 6 weeks, group b participants were given baseline treatment along with mercier therapy 1 session per week for 6 weeks, the post-intervention assessment was done, via the marinoff scale, mankoski pain scale and endometriosis health profile questionnaire (ehp 30). data was analyzed by using spss version 26. detailed description: endometriosis

endometriosis is the condition involving the presence of glands or stroma of the endometrial lining outside the uterus cavity. its characteristics include unpleasant pain in the pelvic region, impaired fertility, pain during or after sex, and heavy bleeding during periods. endometriosis occurs as a result of genetic, angiogenic, immunological, and inflammatory factors. in endometriosis, adhesions may be formed due to local inflammation. it can also occur as the blood-filled implants start bleeding in their surroundings. as a result of this bleeding healing occurs which causes scar formation. pharmacologically, nsaids are used for instant pain relief. the most common surgical approach is laparoscopy. physiotherapy in its various forms can be an excellent complement to the gynecological treatment of endometriosis. as previous studies also reported the effect of pelvic massage, pelvic manipulation, kinesiotherapy, and hydrotherapy. according to researcher knowledge, there is limited evidence on wurn technique and mercier therapy and how these techniques improve dyspareunia, dysmenorrhea, and quality of life in women with endometriosis. this study aims to see the comparative effects of wurn technique and mercier therapy on dyspareunia, dysmenorrhea, and quality of life in women with endometriosis.

Eligibility criteria:
inclusion criteria: * age ranging from 25-43(17) * diagnosed patients with endometriosis * bmi (18.5-29.9),(normal and overweight) * multigravida * mode of delivery: vaginal delivery or c section both * females having grade 1 or 2 grade on the dyspareunia scale * females having moderate scores on ehp -30 exclusion criteria: * malignancy * pregnancy * fibroids * pelvic congestion syndrome * pelvic inflammatory disease * females having iud (inter uterine device) * recent abdominal or pelvic surgery * ovarian abscess

Keywords: dyspareunia dysmenorrhea endometriosis
effect of dairy fat on plasma phytanic acid in human

Conditions: Coronary Heart Disease

Summary: the aim of the study is to investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human.


Eligibility criteria:
inclusion criteria: * sign written consent * age: 20-42 * bmi: 20-30 * increased risk of developing ms * refrain from dietary supplements and blood donations prior to, and during the study exclusion criteria: * poor compliance * if they suffering from any chronic or long lasting illness * abuse of alcohol or medicine
pharmacodynamic bioequivalence study of albuterol sulfate inhalation aerosol, 0.09 mg albuterol base/ inhalation

Conditions: Bronchial Asthma

Summary: pharmacodynamic bioequivalence study of albuterol sulfate inhalation aerosol 0.09 mg

to assess the pharmacodynamic bioequivalence of albuterol sulfate inhalation aerosol 0.09 mg base/ inh \[aurobindo pharma, usa, inc\] compared to authorized generic drug albuterol sulfate hfa inhalation aerosol 0.09 mg per actuation \[teva pharmaceuticals usa, inc\] in stable mild asthma patients, under methacholine induced bronchoprovocation.

Eligibility criteria:
inclusion criteria: 1. male and non-pregnant female subjects (18-65 years of age). 2. stable mild asthmatics based on national asthma education and prevention program (naepp) guidelines. 3. fev1 ≥ 80% of predicted. 4. airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) pc20 ≤ 8 mg/ml or equivalent pd20. 5. nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years). 6. written informed consent. exclusion criteria: 1. evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study. 2. history of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season. 3. history of cystic fibrosis, bronchiectasis or other respiratory diseases. 4. history of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ecg with evidence of ischemic heart disease. 5. treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months. 6. known intolerance or hypersensitivity to any component of the albuterol mdi
to assess the level of adherence of subjects receiving saizen® via easypod™ in columbia

Conditions: Growth Disorders

Summary: this is a columbian, multicentre, observational study to evaluate adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational study. parents/subjects will provide their informed consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected both retrospectively and prospectively. this will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: • to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to identify adherence subject profiling * to assess the impact of adherence on insulin-like growth factor 1 (igf1) (i.e. above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to summary of product characteristic (smpc) * over the age of \>2 years * under \<18 years of age, or over 18 without fusion of growth plates * parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the smpc * use of an investigational drug or participation in another interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
non-myeloablative allogeneic transplant for myelodysplastic syndromes and myeloproliferative disorders

Conditions: Myelodysplastic Syndromes; Myeloproliferative Disorders; Blood and Marrow Transplant (BMT); Myelodysplastic Syndromes (MDS); Myeloproliferative Disorders (MPD)

Summary: to improve survival outcomes for patients with mds and mpd with a nonmyeloablative allogeneic hematopoietic cell transplant.

non-myeloablative allogeneic hematopoietic cell transplantation for treatment of myelodysplastic syndromes and myeloproliferative disorders (except cml)

Eligibility criteria:
inclusion criteria:- myelodysplastic syndromes * myeloproliferative disorders * hla matched donor available exclusion criteria:- organ dysfunction * hiv positive
alzheimer's disease prevention trial

Conditions: Alzheimer Disease; Memory Disorders

Summary: this is a three-year study to determine if estrogens can prevent memory loss and alzheimer's disease in women with a family history of alzheimer's disease.

preventing postmenopausal memory loss and alzheimer's with replacement estrogens (prepare) is a double-blind-placebo controlled trial to determine whether estrogen (or estrogen and progesterone) can delay the onset of memory loss or alzheimer's disease in elderly women with a family history of the disease.

Eligibility criteria:
inclusion criteria: * healthy women 65 or older with a family history of memory problems not currently on estrogen. exclusion criteria: * significant neurological impairment * current estrogen use * history of breast cancer

Keywords: alzheimer's disease memory loss estrogen