Kornimate/medical-research-clean huggingface dataset:
increased monitoring of physical activity and calories with technology

Conditions: Weight Change, Body; Behavior, Health; Obesity, Childhood; Parent-Child Relations

Summary: since severe obesity in youth has been steadily increasing. specialized pediatric obesity clinics provide programs to aid in reducing obesity. since the home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during behavioral weight loss interventions, a family-based treatment approach is best. this strategy has been moderately successful in our existing, evidence-based pediatric weight management program, brenner families in training (brenner fit). however, since programs such as brenner families in training rely on face-to-face interactions and delivery, they are sometimes by the time constraints experienced by families. therefore, the purpose of this study is to develop and pilot a tailored, mobile health component to potentially increase the benefits seen by brenner fit standard program components and similar pediatric weight management programs.

for this project, we will randomize 80 youth with obesity (13 - 18yrs) and a caregiver (dyads) to the brenner families in training (fit) group or the brenner families in training mobile (mfit) group. all youth participants will receive a commercially available activity monitor. caregivers will receive podcasts with a story about a caregiver supporting weight loss in a child by providing healthy foods/activities for his/her family, including healthy eating and physical activity information. children will receive animated videos that contain healthy eating and physical activity messaging, with an engaging story of a child losing weight. all participants will have access to a website and mobile apps where they will track weight, diet, and physical activity for themselves (youth) or their child (parents). based on their reports of weight, eating, and physical activity, the messaging received from clinical staff by the families will be individually tailored to promote healthy behaviors and overcome perceived barriers. the proposed research is innovative in that it explicitly incorporates theory into the intervention and evaluation components of the project and builds upon an existing literature on mobile health interventions that use mobile technology.

Eligibility criteria:
inclusion criteria: youth with obesity, 13 - 18yrs, who are enrolled or eligible to enroll in brenner families in training (fit). caregivers must live in the home with their youth participants. obesity is defined a bmi (35.9 +/- 8.6). participants must also have access to a smartphone or tablet exclusion criteria: adolescents under the age of 13 will be excluded. if participants do not have access to a smartphone or tablet, they will not be able to participate.

Keywords: weight management pediatric weight management mhealth mobile technology parent/child relations dyad
efficacy and safety of lithium carbonate in the treatment of chronic spinal cord injuries

Conditions: Spinal Cord Injury

Summary: this is a randomized, placebo-controlled, double-blinded trial. forty patients will be randomized into two groups. the subjects in the treatment group will be administered with lithium carbonate, while the control group will receive placebo. each subject will receive oral lithium carbonate or placebo for six weeks. in the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment. the outcomes will be assessed 6 weeks and 6 months after the onset of the medication. the outcomes will be compared with baseline pre-treatment data to obtain "neurological change scores." the efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.


Eligibility criteria:
inclusion criteria: * subjects of either gender and 18-60 years of age; * subjects with chromic spinal cord injury (defined as a history of spinal cord injury for 12 months or longer); * subjects with asia - classification of a, b, or c for at least 6 months unchanged; * spinal cord injury vertebral level should be between c4 and t10; * subjects must be able to read, understand, and complete the vas; * subjects who have voluntarily signed and dated an informed consent form, approved by an irb/iec, prior to any study specific procedures. exclusion criteria: * a history of hypersensitivity or other adverse reaction to lithium; * significant renal, cardiovascular, hepatic and psychiatric disease; * significant medical diseases or infection; * addison's disease; * debilitation or dehydration; * recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, nsaids and tetracyclines; * a history of alcohol abuse or drug abuse; * pregnant or lactating women; * female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study; * subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study; * subjects who have taken lithium for manic depression or other psychiatric conditions,and finally; * any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

Keywords: spinal cord injury
the long term effects of alfuzosin(xatral xl) in lower urinary tract symptoms(luts)/bph patients

Conditions: BPH

Summary: benign prostatic hyperplasia (bph) is a common condition among older men. the efficacy of α1-blockers for treating bph has been well documented and they are recommended for the treatment of bph by clinical guidelines. it is not well known if a stratification based on the grade of boo and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. in our study, we investigated possible differences in treatment outcome between patients with and without boo, and with or without proper contractility who are treated with alfuzosin. so we will compare the quantified improvements 12 months after alfuzosin medication in luts/bph patients by the grade of boo and/or bladder contractility.

1. primary objective to evaluate efficacy on voiding and storage symptoms in luts/bph patients after 12 months of treatment with xatral xl® by the grade of bladder outlet obstruction and/or bladder contractility 2. secondary objectives to evaluate efficacy on voiding and storage symptoms in luts/bph patients after 3 months and 6 months of treatment with xatral xl® by the grade of bladder outlet obstruction and/or bladder contractility to evaluate efficacy on maximal flow rate (mfr) and post-voided residual urine (pvr) to evaluate on voiding frequency, urgency severity \& frequency, and nocturia to evaluate patient tolerability to the medication to evaluate global impression of improvement (gii)

Eligibility criteria:
inclusion criteria: * ambulatory males (≥50 years) suffering from luts suggestive of bph * patients satisfying all of the following: * moderate to severe luts : * international prostate symptom score (ipss)≥ 8 * an enlarged prostate (≥25 ml) * decreased peak flow rate : qmax ≤15 ml/s (volume voided ≥ 120 ml) exclusion criteria: * post voided residual urine ≥ 200 ml * patients performing catheterization * urinary tract infection patients * patients taking 5 alpha reductase inhibitor * known hypersensitivity to alfuzosin * history of postural hypotension or syncope * hypertension patients treated with other alpha1-blockers * patients newly taking anticholinergic medication within 1 month * hepatic insufficiency (aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range) * renal insufficiency (s-cr ≥ 2mg/dl) * unstable angina pectoris * uninvestigated hematuria * serum prostate specific antigen ≥ 4 ng/ml (biopsy proven no cancer patients can be included) * interstitial cystitis patients * severe concomitant condition threatening life. * patient who is unable to make voiding diary * bladder or prostate cancer patients * patients receiving prostate or bladder surgery

Keywords: luts bph bladder outlet obstruction bladder contractility
families moving forward (fmf) connect pro for mental health providers

Conditions: Fetal Alcohol Spectrum Disorders

Summary: the goal of this clinical trial is to test a new provider-assisted version of the caregiver families moving forward (fmf) connect app ("fmf connect pro") with mental health providers in the united states. in fmf connect pro, mental health providers learn to do routine screening for prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (fasd), and support families in using the fmf connect caregiver app. two different training methods will be compared with a waitlist group in this study. the first training method involves 13-sessions of tele-mentoring using an extension of community healthcare outcomes (echo) approach. the second training method involves a self-directed approach in which providers will access similar content in any asynchronous format on a website. the main questions this study aims to answer are: * what is the proportion of agencies and providers who accept and participate in the clinical trial (reach)? * do study groups differ on provider outcome measures of effectiveness (clients screened/diagnosed), adoption (provider change in knowledge, self-efficacy), implementation (practice change, fmf connect pro dashboard usage), and maintenance of fasd-informed care practice change? all mental health providers in the study will complete online assessments at study entry, 6 months, and 12 months.


Eligibility criteria:
inclusion criteria: * licensed mental health provider or supervised trainee * employed by a community mental agency or in private practice * provides mental health services to children ages 3 to 12 or their families * provides services in the united states * fluency in english * access to the internet exclusion criteria: * provides services outside of the united states * does not provide mental health services to children ages 3 to 12
evaluation of topical citrullus colocynthis fruit oil efficacy in treatment of painful peripheral diabetic neuropathy

Conditions: Diabetic Neuropathies

Summary: this study is designed to evaluate the topical citrullus colocynthis fruit oil efficacy in treatment of painful peripheral diabetic neuropathy (pdn) in a randomized double blind placebo-controlled clinical trial design. this study includes 60 patients from sums endocrinology and diabetes clinic. patients with painful conditions other than pdn such as radiculopathies will be excluded. after giving the informed consent the patients will be underwent ncs (nerve conduction study) for confirming the diagnosis before recruitment. they will be followed for 12 weeks and after 12 weeks the outcome measures including neuropathic pain scale (nps), whoqol-bref (world health organisation quality of life brief) questionnaire and electrodiagnostic criteria will be evaluated.


Eligibility criteria:
inclusion criteria: * controlled type 1 or 2 diabetes mellitus * painful peripheral diabetic neuropathy for more than 3 months * age more than 18 years old * patients consent on enrolling study and admitting study protocol exclusion criteria: * other causes of pain in lower extremities like lumbar disk herniation * ulcerative lesions in lower extremities * dermatitis * pregnancy * lactation * citrullus colocynthis allergy * unstable cardiac, neurological or renal disease * diagnosed other types of neuropathy

Keywords: diabetes mellitus diabetes complications pain
efficacy and safety of raltitrexed-based transarterial chemoembolisation(tace)for colorectal cancer liver metastases

Conditions: Colorectal Cancer Metastatic

Summary: to evaluate the efficacy and safety of raltitrexed for advanced colorectal cancer

evaluate the efficacy and safety of raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed colorectal adenocarcinoma 2. disease limited to the liver unresectable disease by surgery or other local therapies 3. age \>18 years 4. ecog performance status 0-2,child pugh a or b 5. expected survival ≥ 3 months 6. adequate hematological, hepatic, and renal function exclusion criteria: 1. pregnant or lactating women 2. patients with severe organ dysfunction or failure 3. with severe cardiovascular disease, or mental 4. extraliver metastases

Keywords: advanced colorectal cancer of liver metastatic
zinc for infection prevention in sickle cell anemia-2 (zips-2)

Conditions: Sickle Cell Disease

Summary: a randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in ugandan children with sickle cell anemia (sca)

the study will be a randomized, placebo-controlled, double blind clinical trial in which 100 ugandan children 1.00-4.99 years of age with sca will receive zinc (20 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 6 months. the primary study outcome will be incidence of infection (all causes).

Eligibility criteria:
inclusion criteria: * documented sickle cell anemia (hbss supported by hemoglobin electrophoresis) * age range of 1.00-4.99 years, inclusive, at the time of enrollment * weight at least 5.0 kg at the time of enrollment * willingness to comply with all study-related treatments, evaluations, and follow-up * children whose parents or guardians give full written informed consent exclusion criteria: * known other chronic medical condition (e.g., hiv, malignancy, active clinical tuberculosis) * severe malnutrition determined by impaired growth parameters as defined by who (weight for length/height or height for age z-score \<-3, using who growth standards) * absolute neutropenia (absolute neutrophil count \<500)

Keywords: zinc all-cause infections
comparison of tolerability between two allergy drops

Conditions: Allergic Conjunctivitis

Summary: comfort is compared between two allergy drops


Eligibility criteria:
inclusion criteria: * between the ages of 18 and over inclusive. * males or females * patient is in generally good \& stable overall health. * patient likely to comply with study guidelines \& study visits. * informed consent signed. * history of allergic conjunctivitis * current symptoms of allergic conjunctivitis assessed by the investigator exclusion criteria: * corneal refractive surgery or contact lens wear within 6 months of this study. * current use of restasis * intra-ocular surgery within 6 months or ocular laser surgery within 6 months. * pregnant or lactating women. * ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Keywords: allergic conjunctivitis
development and evaluation of sm-art intervention (sm-art)

Conditions: Perinatal Depression; Resilience; Anxiety; Marital Conflict

Summary: the approach of this intended research is to help pregnant women practice constructive coping and proactive skills that focus on positive adaptation for safe motherhood through our developed intervention. the objective of this two phases randomized control trial is to develop contextually based "sm-art" intervention \[safe motherhood art: accessible resilience training\] and evaluate the effectiveness of "sm-art" intervention in a sample of pregnant women living in low socioeconomic urban areas of karachi, pakistan. it is hypothesized that the sm-art intervention will enhance resilience and marital harmony and decrease symptoms of depression, anxiety in pregnant women.

the prevalence of perinatal depression and anxiety in south asia are among the highest in the world. in pakistan, approximately 18% to 60% of women experienced depressive symptoms at some point during their pregnancy. early intervention for the management of mental illness in pregnancy is imperative as the effects of perinatal mental ill-health is not only limited to mothers but also can negatively impact child health outcomes. in a public health context, positive psychological interventions should be promoted as it reduces the burden of treatment, and enhance cost effective approaches in resource poor countries such as pakistan. as in pakistan, no program has been planned and tested to enhance the positive psychological wellbeing among pregnant women that is based on individual strengths, that can be learnt, sustained and low cost as well. hence, this study aims to facilitate pregnant women in practicing constructive coping and proactive skills which will help them to focus more on the positive approach of life rather than looking for the negative situations that is carried out in their daily lives. the study will carried out in two phases: phase i: the objective of phase one is study is to develop "sm-art" intervention \[safe motherhood art: accessible resilience training\] phase ii: the objective of phase two is to test the effectiveness of "sm-art" intervention \[safe motherhood art: accessible resilience training\] to improve resilience, marital harmony and decrease depression and pregnancy related anxiety in a sample of pregnant women presenting to koohi goth hospital of karachi, pakistan

Eligibility criteria:
inclusion criteria: 1. all participants should provide written consent, be 18+ years of age 2. all participants should be currently married at a gestational age of 12 to 30 weeks: by 12th week, pregnancy is confirmed, they do visit health clinic and upper bar is set to 30 weeks so there should be adequate time to provide the intervention and observe the effectiveness. 3. participants should speak and understand urdu, as all our assessments and intervention will be in local language. exclusion criteria: participants with a history of mental illness and/or physical illness will be excluded as will those taking antianxiety, antidepressant, anti psychotic medication.

Keywords: resilience perinatal mental health depression
intravenous tedisamil in the rapid conversion of atrial fibrillation or flutter to normal sinus rhythm in male subjects

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: the purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (nsr) in male patients.


Eligibility criteria:
inclusion criteria: * willing to sign informed consent before screening examinations are performed and before the study drug is administered * males \> 18 years of age * subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration \> 3 hours and \< 45 days) at the time of randomization * subjects who are in no distress and hemodynamically stable (supine systolic blood pressure \> 90 mmhg and diastolic blood pressure \< 105 mmhg) exclusion criteria: * acute myocardial infarction and cerebrovascular accidents * coronary and heart failure symptoms * life-threatening ventricular arrhythmias and electrocardiogram (ecg) abnormalities * electrolyte abnormalities * concurrent antiarrhythmic treatments

Keywords: atrial fibrillation atrial flutter anti-arrhythmic agents conversion to normal sinus rhythm
validation of brain function assessment algorithm for mtbi/concussion in college athletes

Conditions: Brain Injuries, Traumatic; Concussion, Mild; Concussion, Brain; Concussion, Severe; Concussion, Intermediate

Summary: this study is part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. this data will be combined with that collected under nct03671083 (part 2 with subject age range 13-25 years) for the final analyses of validation of the algorithms.

eeg, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined return to play (rtp) and 45 days after rtp, for the purpose of independently validating the performance of the algorithms developed in prior studies (nct02477943, nct02661633 and nctxxxxxx). data collected under this study will be combined with that collected under nct03671083 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. subjects will come from the sports and other populations of concussed individuals. they will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. an additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point.

Eligibility criteria:
inclusion criteria (for injured subjects): 1. time of injury within 72 hours of brainscope battery 2. no evidence of abnormality visible on computerized tomography (ct) of the head related to the traumatic event (note: neuroimaging is not required for enrollment) 3. no hospital admission due to either head injury or collateral injuries for \>24 hours 4. gcs between 13-15 exclusion criteria: 1. previously enrolled as an injured or matched control subject in the brainscope algorithm development study 2. current cns active prescription medications taken daily, with the exception of medications being taken for the treatment of attention deficit disorder (add) or attention deficit hyperactivity disorder (adhd) 3. forehead, scalp or skull abnormalities that prevents headset application or eeg data collection 4. history of brain surgery or neurological disease 5. pregnant women 6. do not speak or read english 7. loss of consciousness ≥ 20 minutes related to the concussion injury - for injured subjects only 8. prior history of concussion in the last year - for matched control subjects only

Keywords: concussion mild traumatic brain injury sport related concussion
culturally-tailored hiv risk reduction for african-american msm

Conditions: HIV Infections

Summary: the purpose of this study to conduct a small randomized control trial to compare the relative effectiveness of a single-session of hiv testing and counseling risk reduction intervention (hct-only) to an enhanced intervention that includes the standard hct intervention plus a theory-based and culturally-tailored group-level intervention designed to reduce or eliminate hiv and sti risk behaviors (hct-plus) among african-american men who have sex with men (aa-msm).

the hct-plus intervention will consist of the hct-only intervention, as well as 8 small group intervention sessions focused on hiv risk reduction. small groups will consist of 10 men who will meet once-a-week for 8 consecutive weeks. each meeting will last approximately 2 hours. in each small group session, staff will work with men to reassess their hiv risk behavior, re-prioritize their goals as appropriate, and provide motivational support for their risk reduction accomplishments. participants will be asked to discuss ways they have successfully avoided hiv risk behavior since the previous session, as well as to discuss situations in which they found it difficult to avoid risk. staff will reinforce successful risk avoidance, and problem-solve with men to overcome barriers to risk reduction.

Eligibility criteria:
inclusion criteria: * reside in milwaukee county; * are at least 18 years of age; * self-identify as male; * self-identify as black or african-american; * can provide informed consent; * report unprotected anal sex with a man in the past 3 months; * report at least two sexual partners with whom they have had unprotected anal or vaginal sex in the past 3 months; * are willing to be tested for hiv using rapid oral fluid procedures or willing to provide evidence of hiv seropositivity exclusion criteria: * under 18 years of age, * involvement in a hiv prevention study currently or in the past 6 months, * participation in the pilot phase

Keywords: hiv prevention african american black gay men who have sex men hiv seronegativity