Kornimate/medical-research-clean huggingface dataset:
effectiveness of team treatment of depression in primary care

Conditions: Depression; Primary Health Care

Summary: most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. a collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.

background: most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. a collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings. objectives: this effectiveness study adapted collaborative care to the va primary care setting ("collaborative care") and compared it with consult-liaison care ("cl care"). methods: patients within a va primary care clinic were randomly assigned by firm to the two interventions. in collaborative care, existing staff resources were reorganized to form a multidisciplinary mental health specialist team. the team developed a treatment plan based on an initial assessment and suggested the plan to the primary care provider. primary care providers' treatment efforts were then supported by brief social work telephone calls designed to support adherence and monitor symptomatology. treatment results were systematically reviewed and suggestions for treatment modification were fed back to the primary providers. in cl care, the primary care providers were informed of the diagnosis and study clinicians facilitated referrals to psychiatry residents in-clinic as requested. mailed and in-clinic surveys and provider referral were used to recruit 168 collaborative care and 186 cl care patients who met criteria for major depression and/or dysthymia based on structured interview. patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, or had primary alcohol abuse. outcome data on the scl-20 depression symptomatology measure, veterans sf-36, and sheehan disability scale were collected at baseline, 3 and 9 months. va utilization and costs of care were analyzed. status: complete. final report submitted june 30, 2001.

Eligibility criteria:
inclusion criteria: several screening methods including mailed and in-clinic surveys and provider referral were used to recruit 168 team and 188 cl study patients who met criteria for major depression and/or dysthymia based on structured interview. patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, had primary alcohol abuse, or were too impaired to participate in the screening interview. outcome data on the scl-20 depression symptomatology measure, sf-36v, and sheehan functional impairment measure were collected at baseline, 3 and 9 months. exclusion criteria:
safety, tolerability and efficacy of the transdermal system in elderly subjects with major depression

Conditions: Major Depression

Summary: objective of this 16-week, open-label study is to assess the safety and tolerability of once daily application of three doses of sts during continuous dosing in the treatment of elderly subjects with major depression. subjects will have study visits (clinic visits) at beginning of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.


Eligibility criteria:
* men/women in good health 65 years or older * ability to read, understand and sign study informed consent * major depression- mild to severe based on rating scale

Keywords: depression
study with two coenzyme q10 products

Conditions: Coenzyme Q Deficiency

Summary: the randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme q10 products

the randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme q10 products will include 35 subjects who will test two different coenzyme q10 products. plasma concentration of coenzyme q10 will be measured.

Eligibility criteria:
inclusion criteria: * subject informed consent form * aged between 50 and 65 years old * body mass for women 70± 5 kg and for men 85± 5 kg * non-smoking * healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases * absence of any prescribed medication during the study * willing to avoid a consumption of any food supplements at least 2 weeks before and during the study exclusion criteria: * cardio-vascular diseases, diabetes, neurodegenerative diseases, gastrointestinal disorders, pregnancy, breast-feeding * intake of any food supplements within two week of the beginning of the study * drug or alcohol abuse

Keywords: single dose bioavailability coenzyme q10
uk ibrance patient program (ipp) study

Conditions: HR+/HER2- Locally Advanced, Metastatic Breast Cancer

Summary: what are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in united kingdom patients with hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast cancer treated as part of the ipp?

hormone receptor positive (hr+) breast cancer (bc) represents the largest therapeutic subtype of the disease, accounting for 60 to 65% of all malignant neoplasms of the breast. palbociclib (ibrance®) is a small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (cdk4/6) which in clinical trial settings has been shown to increase progression-free survival (pfs) for patients with hr+, human epidermal growth factor 2-negative (her2-) metastatic breast cancer (mbc). palbociclib first received a european union (eu) marketing authorisation in september 2016, to be commercialised as ibrance® by pfizer. palbociclib was recommended for use with an aromatase inhibitor in patients with hr+/her2- locally advanced and mbc in the national health service (nhs) in england by the national institute for health and care excellence (nice) in november 2017 and by the scottish medicines consortium (smc) in december 2017. in order to provide access to palbociclib in the united kingdom (uk) during the nice/smc appraisal period, the ibrance® patient program (ipp) was initiated and run by pfizer between april 2017 until a positive nice/smc appraisal in november 2017 (for england and wales) or december 2017 (for scotland). pfizer are interested in the opportunity to collect data from patients who received palbociclib as part of the uk ipp, to better understand patients' characteristics in a routine care setting, treatment persistence and dose management, clinical outcomes, and healthcare resource utilisation. this study will provide real-world evidence on patients' clinical progression and experience of treatment with palbociclib in routine clinical settings in a uk context. research question: what are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in united kingdom patients with hr+/her2- mbc treated as part of the ipp?

Eligibility criteria:
inclusion criteria: all patients meeting the following eligibility criteria will be included in the study: * patients enrolled into the ipp at one of the selected hospitals (see annex 1 for ipp enrolment letter). * patients who received ≥1 dose of palbociclib as part of the ipp at one of the selected sites. * for sites where data collection is performed by ph associates, written informed consent will be required from living patients to access their medical records. * patient aged ≥18 years old at enrollment into the ipp
submacular hemorrhage associated with retinal arterial macro aneurysm

Conditions: Submacular Hemorrhage; Ruptured Retinal Arterial Macro Aneurysms

Summary: evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.


Eligibility criteria:
inclusion criteria: * the patients with sub macular hemorrhage associated with ruptured retinal arterial macro aneurysms exclusion criteria: * the eyes with preretinal or intraretinal hemorrhage at the fovea * the patients with follow-up less than 3 months

Keywords: submacular hemorrhage vitrectomy tissue- plasminogen activator
thoracic epidural anesthesia reduces mortality and rehospitalization for patients with heart failure with reduced ejection fraction

Conditions: Heart Failure With Reduced Ejection Fraction; Thoracic Epidural Anesthesia

Summary: despite significant scientific breakthrough in management, patients with heart failure with reduced ejection fraction (hfref) remain high morbidity and mortality, with a 5-year survival rate of 25% after hospitalization for hfref. the autonomic nervous system (ans), particularly the sympathetic nervous system (sns), plays a critical compensatory role in maintaining cardiovascular homeostasis in the failing heart. this is critical given the huge unmet need for novel treatment strategies for hfref. thoracic epidural anesthesia (tea), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the t1 to t4 levels in thoracic and abdominal surgical procedures. since 1995, professor liu fengqi has pioneered the use of tea to treat end-stage hfref and achieved surprising results. tea could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. currently, thousands of hfref patients have received tea procedure. however, it is unclear whether tea could positively impact the clinical outcomes of patients with hfref.


Eligibility criteria:
inclusion criteria: * the present study was a retrospective, observational, matched case-control study of 1,840 consecutive inpatients, in new york heart association functional class ii-iv with a left ventricular ejection fraction (lvef) ≤40%, who were hospitalized from july 2013 to august 2019. exclusion criteria: * patients were excluded because of insufficient patient information, refusal to participate, or loss to follow-up by telephone. in patients with multiple hospitalizations during the time period, the first hospitalization was utilized in the analysis.
"effectiveness of school-based substance abuse prevention programme among adolescents .

Conditions: Substance Abuse

Summary: the objectives of the study is to 1. "to explore the perception of teachers, parents \& students in the prevention of substance abuse among adolescents". 2. "to develop and determine the effectiveness of a school-based substance abuse prevention programme (sspp) on awareness, attitude, peer pressure, and life skills towards prevention of substance abuse". in this study, sspp refers to a bilingual multicomponent training programme which includes psychoeducation and video-assisted teaching to enhance awareness of substance abuse, role-play to develop a positive attitude towards prevention of substance abuse, case based scenario to increase resistance to peer pressure and storytelling and demonstration to increase life skills towards prevention of substance abuse among adolescents of selected schools of pokhara, nepal.

detailed methodology phase i: * research design: qualitative * research setting: selected public schools of pokhara, nepal * population: teachers, parents, and students of pokhara, nepal * samples: selected teachers, parents \& students * sample size: 38 (the sample will be collected till data saturation) * data collection technique: focus group discussion * data collection tool: focus group lead questions * data analysis: thematic analysis (atlas.ti) phase ii research design: cluster randomized trial randomization method: cluster randomization research setting: selected public schools of pokhara, nepal population: adolescent students of pokhara, nepal sample: selected adolescents, who are in the age group 13-15 years old and studying in 8th \& 9th grades variables * independent variables: school-based substance abuse prevention programme (sspp) * dependent variables: awareness, attitudes, peer pressure, and life skills related to prevention of substance abuse. * demographic variables: age in years, gender, religion, education/grade, family type, residence, number of siblings, education of parents, occupation of parents, sources of information, history of substance abuse in the family. sample size: 210 the expected outcomes of the study is to enhance awareness towards prevention of substance abuse,develop a positive attitude towards the prevention of substance abuse,develop drug refusal skills among adolescents,improve life skills and helps in th reduction of drug abuse behaviour adolescents

Eligibility criteria:
inclusion criteria: * adolescents of 13-15 years age group. * those who are studying in selected public schools of pokhara, nepal. exclusion criteria: * o adolescents who are not willing to provide informed consent (assent) and parental consent. * adolescents who do not belong to nepal. * adolescents who are absent during data collection
safety and efficacy of oral agn 203818 for the relief of irritable bowel syndrome pain

Conditions: Irritable Bowel Syndrome

Summary: this study will explore the safety and effectiveness of different doses of agn 203818 in relieving irritable bowel syndrome pain. the study is being conducted in 2 parts. part a enrolled 213 pts dosed with either 3, 20, 60 mg agn 203818 or placebo over 4 week treatment duration. part b will enroll 320 pts and dose with either 60, 100, 160 mg bid agn 203818 or placebo over 12 week treatment duration.


Eligibility criteria:
inclusion criteria: * diagnosis of irritable bowel syndrome * moderate or severe ibs pain exclusion criteria: * any other uncontrolled disease * pregnant or nursing females
controlled study of ono-5046na in patients with acute respiratory failure associated with community-acquired pneumonia

Conditions: Community-acquired Pneumonia

Summary: the purpose of this study is to determine the safety and efficacy of ono-5046na in patients with acute respiratory failure associated with community-acquired pneumonia


Eligibility criteria:
inclusion criteria: * patients with community-acquired pneumonia * patients with acute respiratory failure exclusion criteria: * patients with nosocomial pneumonia * patients on mechanical ventilation

Keywords: ono-5046na acute respiratory failure community-acquired pneumonia
observational study of specificity of mycobacterium tuberculosis screening and diagnostics in hiv-infected individuals

Conditions: HIV Infections; Tuberculosis

Summary: an estimated 3 million hiv-infected individuals will enter programs for antiretroviral (arv) treatment in the coming year, with projected rates of requirement for arv therapy extending to more than 10 million in sub-saharan africa, southeastern asia, and latin america in the coming decade. in these settings, tuberculosis (tb) is an endemic infection in the population, and an estimated 30-60% of adults have been infected with tb, the leading opportunistic infection associated with hiv infection. the purpose of this study is to construct a standardized diagnostic evaluation (sde) for tb that provides an increase in identification of participants with active pulmonary tb, without sacrificing specificity.

well developed tb diagnostic testing, contact tracing, and treatment programs are key parts of the public health and health care infrastructure in many countries where hiv infection has resulted in a 3- to 10-fold increase in clinical tb, accompanied by increasing hiv prevalence. the primary purpose of this study is to construct a standardized diagnostic evaluation (sde) for tb that provides an increase in identification of participants with active pulmonary tb, without sacrificing specificity. this observational study will include participants who are hiv-infected and tb-uninfected and not receiving arv therapy. the duration of this trial will last between 1 and 14 days. screening and study entry may occur at the same visit. all evaluations must be performed within 14 days after the participant is registered. medical and medication history, physical exam, oral examination and swab, chest x-ray, sputum and blood collection, and documentation of ppd/tst (if available) will occur within this 14-day period.

Eligibility criteria:
inclusion criteria: * hiv-infected exclusion criteria: * receipt of art within 90 days prior to study entry * diagnosis of active tb (pulmonary or extrapulmonary) within 90 days prior to study entry * receipt of 7 or more cumulative days of certain medications within 90 days prior to study entry. more information on this criterion can be found in the protocol.

Keywords: pulmonary tuberculosis myobacterium infections
whey protein supplementation in cancer patients

Conditions: Solid Tumors

Summary: nutritional derangements are very common in cancer patients and negatively affect survival, morbidity and quality of life. intervention trials have demonstrated that nutritional counseling can improve energy balance, nutritional status and quality of life in patients undergoing chemo-radiotherapy. oxidative stress plays a role in the tumor-cytotoxic effect of cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse events such as an impairment of nutritional status and quality of life. the nutritional properties of whey protein have recently raised attention. in view of the high content in cysteine these proteins can positively stimulate the synthesis of glutathione which, in turn, could contribute to the modulation of whole-body and cellular redox state. however, evidence on the role of this dietary intervention in cancer patients is limited.


Eligibility criteria:
inclusion criteria: * cancer patients (lung, gastric, pancreatic, breast, colon, esophageal) * eastern cooperative oncology group performance status ≤ 2 * weight loss \>= 10% in the last 6 months * chemotherapy * written informed consent exclusion criteria: * age \< 18 years * ongoing artificial nutrition (enteral or parenteral) * unavailability to planned measurements
glycemic response to road cycling in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to assess the glycemic response to cycling road races (using continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic controls. the investigators will also assess the relationship between power/work during cycling (using a power meter) and the subject's glucose profile.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * a1c ≤8.0% if diagnosed with type 1 dm exclusion criteria: * if diagnosed with type 1 diabetes, has had recurrent severe hypoglycemia (greater than 2 episodes in previous 6 months requiring assistance by a third party) * has any medical condition or medical history that may affect successful completion of the study and/or personal well-being (as assessed by the pi)

Keywords: type 1 diabetes exercise continuous glucose monitoring
chemotherapy in treating patients with advanced sarcoma

Conditions: Ovarian Cancer; Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy consisting of ifosfamide and doxorubicin in patients with advanced sarcoma.

objectives: i. determine the response rate, time to treatment failure, and survival in patients with advanced soft tissue or gynecological sarcoma treated with high-dose ifosfamide and doxorubicin. outline: patients receive ifosfamide iv continuously on days 1-5 and doxorubicin iv on days 1-3. filgrastim (g-csf) is administered subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing through day 16 (or until day 20 if blood counts have not recovered by day 16). courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. patients are followed at treatment failure and then annually thereafter. projected accrual: a total of 16-46 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven advanced soft tissue or gynecologic sarcoma measurable disease no brain metastases (ct scan required if metastases are clinically suspected) patient characteristics: age: 18 to 70 performance status: who 0-2 hematopoietic: wbc at least 3,500/mm3 platelet count at least 100,000/mm3 hepatic: liver function tests no greater than 2 times normal albumin 4.0-6.0 g/dl renal: creatinine clearance at least 60 ml/min cardiovascular: cardiac function normal by muga scan or echocardiogram other: no other prior or concurrent malignancy except radically removed nonmelanomatous skin cancer prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy to the bladder no prior radiotherapy to indicator lesion surgery: not specified

Keywords: stage iii adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage iii uterine sarcoma stage iv uterine sarcoma recurrent uterine sarcoma ovarian sarcoma stage iv adult soft tissue sarcoma
cerebral oxygenation in cardiac arrest and hypothermia

Conditions: Cardiac Arrest

Summary: data indicate that neurological prognostication is difficult after cardiac arrest if mild therapeutic hypothermia is part of the post resuscitation care. cerebral oxygenation detected by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome assessment after cardiac arrest. the investigators hypothesize that cardiac arrest survivors with a continuously low cerebral oxygenation index have a poor prognosis.

the measurement of cerebral oxygen saturation by a non-invasive near-infrared monitor, invos® (in-vivo optical spectroscopy; covidien) can detect changes in oxygen levels reflecting regional blood oxygen saturation of the brain tissue beneath the sensor. if this monitoring can add further information towards reliable prognostication after cardiac arrest is unknown so far.

Eligibility criteria:
inclusion criteria: * over 18 years exclusion criteria: * under 18 years

Keywords: resuscitation hypothermia outcome