Kornimate/medical-research-clean huggingface dataset:
social connectedness group intervention in depression

Conditions: Depression

Summary: this study evaluates the feasibility of the groups for health (g4h) intervention for adults accessing support for depression in the uk. g4h targets improvements in adults' interpersonal functioning in order to reduce feelings of loneliness. the study will adapt the g4h intervention for delivery to adults seeking treatment for depression in the uk and estimate trial parameters (recruitment, retention, missing data and acceptability) of the adapted intervention, prior to a definitive trial. a mixed methods design of interviews and a single group, pre-post study will be employed.

background: loneliness is frequently reported amongst adults with depression. interventions to reduce loneliness in different populations have shown mixed results. the groups for health (g4h) programme has been developed according to the social identity approach within social psychology and has demonstrated preliminary efficacy for reducing loneliness in a proof-of-concept study conducted with australian student sample. the present study will examine whether g4h can be adapted to suit the needs of a clinical population in the context of uk secondary care services. objective: phase 1 - to adapt the g4h intervention for delivery to adults seeking treatment for depression in the uk. phase 2: to estimate trial parameters (recruitment, retention, missing data and acceptability) of the adapted intervention, prior to a definitive trial; to optimise the adapted intervention for delivery to adults accessing treatment for depression in the uk; to optimise evaluation procedures (candidate outcome measures) trial configuration: sequential exploratory mixed methods design. phase 1: one-to-one interviews. phase 2: activity 1 (intervention), single group, pre-post study. activity 2 (interviews): one-to-one interviews. condition: depression interventions: group-based behavioural programme

Eligibility criteria:
inclusion criteria: phase 1 service user participants: * aged 18-65 * accessing treatment for depression * loneliness: score 6 or above on the university of california loneliness scale (ucla-3) (hughes et al., 2004) * able to speak/read english * ability to give informed consent staff participants: - clinical practitioner with at least 6 months experience of working with people with depression phase 2 activity 1: intervention * aged 18-65 * accessing treatment for depression * loneliness: score 6 or above on the university of california loneliness scale (ucla-3) (hughes et al., 2004) * able to speak/read english * ability to give informed consent activity 2: interviews - attended or agreed to attend phase 2, activity 1 exclusion criteria: * none
a study in patients with irritable bowel syndrome to measure hormone response after dosing with gw876008 and gsk561679

Conditions: Irritable Bowel Syndrome

Summary: to better understand the way that gw876008 and gsk561679 work on hormone responses in patients with irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * has ibs as defined by the rome ii criteria. * clinical laboratory tests at screening showing no clinically significant abnormalities in the opinion of the principal investigator. * non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study). exclusion criteria: * as a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study. * subject has any of the following exclusionary psychiatric conditions (note: current diagnoses are to be based on the m.i.n.i administered at screening). * 1. a current dsm-iv axis i disorder such as dysthymia, phobia, major depression, obsessive compulsive disorder, body dysmorphic disorder, or panic disorder as a primary diagnosis currently or within 6 months prior to the screening visit. * 2. a current dsm-iv-tr diagnosis of antisocial or borderline personality disorder, dementia, or another current dsm-iv-tr axis ii diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol; or * 3. a current (within six months prior to screening visit) diagnosis of anorexia nervosa or bulimia; or * 4. a history of schizophrenia, schizoaffective disorder, or a bipolar disorder; or * 5. is currently being treated by medication for any of the above psychiatric disorders. psychiatric medications would include, but not limited to, antidepressants (e.g. ssris, snris, tcas) anxiolytics, antipsychotics * subjects who, in the investigator's judgement, pose a current, serious or suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal. * subjects who have taken any medication for the treatment of ibs within 1 month prior to screening except for anti-diarrhoeal medications or laxatives for control of bowel habit which is allowed if at a stable dose for 2 weeks prior to randomisation. * subjects who are taking nsaids including aspirin on a regular basis or within 48 hours of a study day. * subjects with a history of pud \<10 years ago. * the subject has a history of, or active eating disorder.

Keywords: cortisol, stress, response, irritable bowel syndrome, cytokine.
anti-mullerian hormone in acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: acute lymphoblastic leukemia (all) is the most common childhood malignancy, with current survival rates exceeding 90%. as cure rates improve, increasing attention is focused on survivor quality of life, including fertility. it is generally accepted that cancer treatments in childhood may interfere with gonadal function, reducing the pool of primordial follicles and consequently causing premature menopause in women. anti-mullerian hormone (amh) levels is a valuable quantitative indicator of ovarian reserve, being directly related to the number of antral follicles. the evaluation of this hormone makes it possible to identify women at risk of early menopause and to propose them interventions for monitoring and preservation of oocytes, allowing girls to be able to have children once they reach adulthood. the objective of this study is to determine ovarian reserve in girls with all before and after treatment by means of the evaluation of the amh assay.


Eligibility criteria:
inclusion criteria: * female less than 18 years of age * diagnosis of acute lymphoblastic leukemia * enrollment within the first month after diagnosis exclusion criteria: * previous treatments with cytostatics drugs * all as a second malignancy * syndromic patient or primary hypogonadism

Keywords: acute lymphoblastic leukemia fertility preservation anti-mullerian hormone
drug delivery via pressurized metered-dose inhaler and valved holding chamber in asthmatic children: determination of delivered dose following coordinated and uncoordinated use

Conditions: Asthma

Summary: the primary objective of this study is to determine ex vivo the amount of fluticasone deposited onto a filter (delivered dose) interposed between the optichamber diamond valved holding chamber (vhc) mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation maneuver.


Eligibility criteria:
inclusion criteria: * • asthmatic children between the ages of 5 and 8 followed at arkansas children's hospital. * the subjects must be available to complete the study. * the subject's parent(s) and/or the subject's legal guardian must provide written informed consent to participate in the study. * the subject must provide assent when older than 7 years old. * the subjects should have used a pmdi vhc previously and be able to use a vhc with mouthpiece. * the subjects should have been prescribed fluticasone or another inhaled corticosteroid delivered via a pmdi vhc combination. * clinically stable asthma. * cooperative, i.e., subject should be able to follow and understand instructions. * the subject must satisfy the study investigator about his/her fitness to participate in the study. exclusion criteria: * clinically significant respiratory disease in the previous 4 weeks. * participation in any other clinical trial in the previous 4 weeks. * lack of cooperation, subject cannot follow and understand instructions.

Keywords: pediatric asthma metered dose inhaler valved holding chamber pmdi vhc
characterisation of italian severe uncontrolled asthmatic patients key features when receiving benralizumab

Conditions: Severe Asthma

Summary: this is an observational, italian multi-center, retrospective cohort study with enrollment visit on patients suffering from severe eosinophilic asthma who started benralizumab in the sampling program or as per normal clinical practice in italy.

a retrospective cohort study design involving secondary data collection was chosen to appropriately address the primary objective in a relatively short period of time after enrollment phase initiation: in fact, since the italian sampling program on benralizumab was active since july 2018, clinical data on patients exposed to benralizumab are already available. no treatments will be administered per protocol requirement, but instead according to normal clinical practice; since benralizumab first administration occurs before inclusion in the study (as per chosen study design), the decision to include the patient in the study is clearly separated from the prescription of benralizumab, in accordance with the observational nature of the study. in order to be eligible for the study, for each patient, the index date shall be at least 3 months prior to enrollment.

Eligibility criteria:
inclusion criteria: 1. adult patients (age ≥18 years) at the start of benralizumab treatment within the sampling program or per clinical practice ("index date"). 2. patients with severe eosinophilic asthma requiring a stable treatment of high doses of inhaled corticosteroids and a long acting β2 agonist ± additional asthma controller (according to clinician's judgment). 3. patients who started benralizumab and received at least one injection at least 3 months before enrollment, either within the sampling program or as per routine clinical practice. 4. patients who signed the informed consent and privacy form at enrollment visit. 5. patients with available hospital medical chart since the start of benralizumab treatment within the sampling program or per clinical practice ("index date"). exclusion criteria: 1. patients who, during the observation period, received benralizumab in a clinical experimental trial. 2. patients who, during the observation period, participated in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.
study of clinical types and surgical out come of pediatric exotropia

Conditions: Exotropia

Summary: study aiming to evaluate all children presented to strabismus clinic in ophthalmology department at sohag university hospital with divergent squint (exotropia) and to record surgical outcome of those who underwent strabismus surgery in our hospital

a hospital-based, prospective, interventional study include infants and children up to the age of 15 years with primary concomitant divergent squint (1ry concomitant exotropia),candidate for surgical correction of squint. each patient will be subjected to detailed history and full preoperative ophthalmic \& orthoptic evaluation including: visual acuity , ocular motility in the 6 cardinal directions, hirschberg test \& angle of deviation. ,cover test \& prism cover test for distant \& near fixation,cycloplegic refraction , anterior segment examination, fundus examination. _ post operative follow-up regimen: 1. children will be examined after surgery on: 1st postoperative day, 1st week, 1st month, 3rd month, and 6 months postoperatively. 2. the following will be recorded for each patient: visual acuity, cover test, ocular motility testing, cover test and prism cover test, the degree of postoperative eye position, presence of over-correction or under-correction, and presence of any other complications.

Eligibility criteria:
inclusion criteria: 1. infants and children up to the age of 15 years. 2. primary concomitant divergent squint (1ry concomitant exotropia) 3. candidate for surgical correction of squint exclusion criteria: 1. children with: 1. paralytic squint 2. consecutive exotropia 3. any neurological disorder 4. history of previous squint surgery 5. history of previous other ocular surgery (e.g. congenital cataract \& glaucoma) 2. children who missed follow up.
local, open-label, extension trial of the efficacy and safety of fesoterodine in elderly patients with overactive bladder

Conditions: Urinary Bladder, Overactive

Summary: this is an open-label extension study intended for subjects who have previously completed study a0221045 (fesoterodine in elderly oab patients) and who have been recommended by the investigator as being suitable for the extended use of fesoterodine. data from this study will extend the evaluation of efficacy, tolerability and safety of fesoterodine in older subjects from portugal.


Eligibility criteria:
inclusion criteria: * subjects must have previously completed fesoterodine study a0221045 \[in portugal\] * subjects must be recommended for inclusion by the investigator exclusion criteria: * conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine * predominant stress incontinence as determined by the investigator

Keywords: overactive bladder idiopathic elderly fesoterodine sofia portugal extension study
social cognitive training for psychosis: treatment development

Conditions: Schizophrenia; Psychosis

Summary: the primary aim of this proposal is to develop, refine, manualize and assess the feasibility and preliminary efficacy of a brief, narrowly-focused social cognitive intervention for individuals with psychosis. the intervention will focus on helping individuals interpret social situations, specifically the intentions and feelings of others. study methods include preliminary treatment and manual development based on series of uncontrolled cases, manual refinement, and a small feasibility/efficacy trial of the newly developed intervention.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or other psychotic disorder * age between 18 and 55 * psychiatrically stable * clinician agrees to individual's participation in study * english as primary language exclusion criteria: * current (past 30 days) symptoms of alcohol abuse/dependence * developmental disability * severe auditory/visual impairment or known neurological disorder * participant has a legal conservator

Keywords: schizophrenia treatment social cognition
tsh suppression during radiotherapy on thyroid site to prevent iatrogenic hypothyroidism in pediatric cancer patients

Conditions: Hypothyroidism; Irradiation

Summary: to offer the possibility of a treatment that could achieve a meaningful reduction in the incidence of post-radiation therapy hypothyroidism. thyroid dysfunction may develop from a few months to several years after patients have completed their radiation treatment. in children with chronic diseases, or given lengthy anti-neoplastic treatments, recurrent or persistent endocrine disorders may have a negative effect on growth and development into adulthood.

patients will undergo basal thyroid ultrasound and ft3, ft4, tsh assay. simulations with computed tomography, and computer assisted three-dimensional treatment planning with a dose volume histogram will be used to identify thyroid volumes and corresponding rt isodose distributions. the enrolled patients will be randomly assigned (1:1) to tsh suppression group (experimental group) or non-tsh suppression group (control group). random allocation will be managed centrally by clinical epidemiology and trial organization of the fondazione irccs istituto nazionale dei tumori. the randomization list will be generated by sas software. investigators and patients will not be masked to treatment allocation. from 14 days beforehand and throughout their rt, patients in the experimental arm will receive l-thyroxine in the morning on an empty stomach (half an hour before breakfast), starting with 1-2 μg/kg, and adjusting the dose every 3 days to ensure tsh \< 0.3 μiu/ml before rt beginning. the 0.3 μiu/ml threshold is just below normal range not causing hyperthyroidism, and is defined as "mild" tsh suppression. based on hormone status, l-thyroxine doses will be gradually increased to patients' individual minimum tsh-suppressive dose before starting rt, maintained throughout the treatment, then rapidly tapered off (half dose the next day after rt, 25% the following day and stop).

Eligibility criteria:
inclusion criteria: 1. any patient with medulloblastoma, hodgkin/non-hodgkin lymphoma before radiotherapy (rt) planning including thyroid parenchyma without previous primary or secondary hypothyroidism; 2. written informed consent prior to any study-specific analysis and/or data collection. exclusion criteria: 1. any patient with medulloblastoma, hodgkin/non-hodgkin lymphoma after radiotherapy including thyroid parenchyma; 2. not signed consent.
a study of tirzepatide (ly3298176) in participants with obesity or overweight

Conditions: Overweight; Obesity

Summary: this is a study of tirzepatide in participants with overweight and obesity. the main purpose is to learn more about how tirzepatide affects body weight. the study has two phases: a main phase and an extension phase. the main phase of the study will last 72 weeks. participants with prediabetes will continue in the extension for another 2 years.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * history of at least one unsuccessful dietary effort to lose body weight exclusion criteria: * diabetes mellitus * change in body weight greater than 5 kg within 3 months prior to starting study * obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity * history of pancreatitis * family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men-2) * history of significant active or unstable major depressive disorder (mdd) or other severe psychiatric disorder within the last 2 years * any lifetime history of a suicide attempt

Keywords: metabolism and nutrition disorder prediabetes
safety and tolerability of the ketogenic diet in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (als) patients who are fed through a gastrostomy tube. this is not a study to see if ketogenic diets are effective in the treatment of als.


Eligibility criteria:
inclusion criteria: 1. familial or sporadic als diagnosed as probable, laboratory-supported probable or definite according to the world federation of neurology el escorial criteria 2. age 18 or older 3. capable of providing informed consent and complying with trial procedures 4. gastrostomy tube in place for the prior month 5. appel als score less than 100 6. able to stand on a scale with assistance 7. for patients with appel als scores greater than 80, availability of caregiver who is willing and able to: * prepare, administer and log tube feeds * check and log gastric residuals * assist with weighing subject at home if necessary 8. willing to chart food intake during the six-month study 9. patients either not taking riluzole (rilutek) or minocycline or on a stable dose of these for 30 days 10. not taking coenzyme q10 or on a stable dose and brand for 30 days 11. absence of exclusion criteria exclusion criteria: 1. forced vital capacity \<50% of predicted 2. dependence on mechanical ventilation for more than 12 hours per day 3. exposure to any experimental agent within 30 days of onset of this protocol 4. women who are pregnant or planning to become pregnant 5. women of childbearing potential not practicing contraception 6. enrollment in another research study within 30 days of or during this trial 7. mini-mental state exam (mmse) score \<20 8. patients with symptomatic cardiac disease or hypercholesterolemia 9. patients with myocardial infarction within 6 months of this trial 10. renal dysfunction defined as bun and creatinine \>2xuln 11. known mitochondrial disease 12. bmi\<18.5 13. prior use of a 4:1 ketogenic diet or atkins diet within 1 month of this trial 14. impaired liver function, defined as ast or alt of 3 x uln 15. patients who have a pacemaker or other internal electronic medical device

Keywords: als ketogenic diet
a study of ly900014 in participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare ly900014 with insulin lispro (humalog) in participants with type 2 diabetes mellitus. the study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes ly900014 and the effect of ly900014 on blood sugar levels compared to insulin lispro (humalog). screening is required within 28 days prior to the start of the study. for each participant, the total duration of the clinical trial will be between 3 and 8 weeks.


Eligibility criteria:
inclusion criteria: * are male or female participants with type 2 diabetes mellitus (t2dm) for at least 1 year * have a body mass index (bmi) of 18.5 to 35.0 kilogram per meter square (kg/m²) * have a glycated hemoglobin (hba1c) less than (\<)9.0 percent (%) * have had no episodes of severe hypoglycaemia in the last 6 months exclusion criteria: * have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from t2dm), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data * have a history of renal impairment * have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives * have proliferative retinopathy or maculopathy and/or severe neuropathy
cervical cancer screening strategies

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia; Human Papillomavirus Infection; Cervical Cytology; Cancer Screening

Summary: this study is to investigate retrospectively the results of cervical cytology and high-risk human papillomavirus in the past 20 years recorded in peking union medical college hospital. the histological findings after cervical cancer screening were reviewed. the diagnostic values of different screening strategies were compared based on the results of cervical histology. the primary endpoint is the diagnosis of grade 2 cervical intraepithelial neoplasia (cin2) or more severe lesions (cin2+). the secondary endpoints include following objectives: (1) the invasive procedures needed according to the screening results; (2) the diagnosis of vaginal and/or vulval intraepithelial neoplasia; (3) the persistence and recurrence of human papillomavirus infection; and (4) the cost-effectiveness of screening strategies for cin2+.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * with definite cervical histology after cervical cancer screening, ore with at least one screening test after first testing exclusion criteria: - not meeting all of the inclusion criteria