Kornimate/medical-research-clean huggingface dataset:
depression prevention initiative - a study of interpersonal psychotherapy-adolescent skills training (ipt-ast) in school settings

Conditions: Depression

Summary: this study is a randomized controlled trial comparing interpersonal psychotherapy-adolescent skills training (ipt-ast) to group counseling (gc) for the prevention of depression in adolescents. the project will: (1) identify adolescents with elevated depressive symptoms but who do not meet criteria for a current mood disorder diagnosis; (2) randomize eligible adolescents to either ipt-ast (n = 100) or gc (n = 100); (3) assess depressive symptoms, depressive disorders, global functioning, interpersonal functioning, comorbid conditions and school related indices at baseline, mid-intervention, post-intervention, and at 6-, 12-, 18-, and 24-month follow-up; (4) examine the effects of ipt-ast on depression and various domains of functioning at each time point; and (5) conduct analyses to examine potential mediators and moderators of the association between ipt-ast and depression outcomes. this study will yield data on the efficacy of ipt-ast relative to gc for the prevention of depressive symptoms and depressive disorders. it will also provide information about the mechanisms of action of ipt-ast and determine for whom ipt-ast is most effective.


Eligibility criteria:
inclusion criteria: * in 7th-10th grades at intake * center for epidemiologic studies depression scale(ces-d) score \> 16 * at least 2 symptoms on the k-sads depression section (score of 2 or 3), one of which is either depressed mood, irritability, or anhedonia * adolescent must be english-speaking * parent speaks english or spanish exclusion criteria: * ces-d score \< 15 * fewer than 2 depression symptoms on the k-sads (score of 2 or 3) or 2 or more symptoms on the k-sads with no report of depressed mood, irritability, or anhedonia * suicide attempt or self-mutilation in the past year, current active suicidal ideation, and/or history of a clinically significant suicidal behavior (i.e., with intent to die and high medical lethality) or repeated patterns of self-injurious behavior * presence of current major depressive disorder, dysthymia, substance abuse, schizophrenia, bipolar disorder, conduct disorder, or psychosis

Keywords: depression prevention adolescents
efficacy and safety study of als-l1023 in patients with abdominal obesity of metabolic syndrome

Conditions: Abdominal Obesity Metabolic Syndrome

Summary: the main objective of this study is to evaluate efficacy and safety of als-l1023 tablet in patients with abdominal obesity of metabolic syndrome.


Eligibility criteria:
inclusion criteria: * aged between 20 and 64 years(both genders) * more than 2 among components of the metabolic syndrome * triglyceride \>= 150mg/dl * hdl-d: women \< 50mg/dl or men \< 40mg/dl * hypertension: systolic blood pressure \>= 130mmhg or diastolic blood pressure \>= 85mmhg * hyperglycemia: fasting plasma glucose \>= 100 mg/dl * informed consent awarding exclusion criteria: * alcohol or any drug abuse * any investigational medication during the preceding 3 months
68ga-nym096/177lu-nym096 in metastatic ccrcc

Conditions: Clear Cell Renal Cell Carcinoma

Summary: this is a single-center, phase i study. patients with metastatic clear cell renal cell carcinoma will be recruited in this study to (phase a) evaluate using 68ga-nym096 pet/ct and to (phase b) treat with 177lu-nym096. the study will be conducted in two phases. the purpose is phase a: to evaluate the safety, tolerability, and imaging characteristics of 68ga-nym096 phase b: to evaluate the safety, tolerability, and recommended phase 2 dose of 177lu-nym096


Eligibility criteria:
inclusion criteria: 1. age≥18y 2. histologically or cytologically confirmed metastatic clear cell renal cell carcinoma 3. progression after or cannot undergo standard therapy with tyrosine kinase inhibitor (tki) treatment or tki combined with immune checkpoint inhibitor treatment. 4. presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography / magnetic resonance imaging (ct/mri)) documented within 4 weeks prior to the 68ga-nym096 administration which should be measurable per response evaluation criteria in solid tumors (recist) v1.1. 5. ecog= 0 or 1 6. written informed consent. 7. for phase b: 68ga-nym096 should meet the imaging inclusion criteria exclusion criteria: 1. any major surgery within 12 weeks before enrollment 2. inability to stay in the scanner bed and keep still for the duration of the scan 3. participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to grade ≤1 4. egfr no higher than 30ml/min\*1.73m2 5. inflammatory bowel disease 6. phase a: tki treatment within one week before 68ga-nym096 administration 7. phase b: participants who received any systemic antineoplastic therapy for the underlying disease and/or other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter). 8. any previous ca ix-targeting treatment 9. prior external beam radiation therapy (ebrt) to more than 25% of the bone marrow 10. pregnant or breastfeeding
study of jnj-39758979 in symptomatic adult patients with uncontrolled asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of jnj-39758979 compared with placebo in patients with uncontrolled asthma despite current treatment with inhaled corticosteroids and/or long-acting beta 2-agonist (laba) and/or montelukast for at least 4 weeks.

this is a two-part study; each part of the study (part 1 and part 2) will be approximately 34 weeks in duration including a 4-week screening phase, a 24-week placebo-controlled treatment phase and a six-week follow-up phase. in part 1, patients will be randomly assigned to receive placebo or jnj-39758979 300 mg once daily through week 24. in part 2, patients will be randomly assigned to 1 of 4 treatment groups to receive treatment with placebo, 30 mg, 100 mg, or 300 mg of jnj-39758979 once daily through week 24. safety assessments and evaluations to determine the efficacy of jnj-39758979 to reduce the signs and symptoms of asthma will be performed both on a daily basis via electronic diary and at study visits.

Eligibility criteria:
inclusion criteria: * has a diagnosis of asthma for at least 6 months before screening. -has been receiving inhaled corticosteroids (≤ 1000 µg fluticasone or its equivalent) alone or in conjunction with long-acting beta 2-agonist (salmeterol, formoterol, etc.) and/or montelukast. * have an acq score ≥ 1.5 at screening. - must be healthy and medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ecg) performed at screening * must be post-menopausal or if pre-menopausal, must use an acceptable method of birth control. exclusion criteria: * has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit admission due to asthma. -has a history of any other chronic respiratory condition including chronic obstructive pulmonary disease, bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea or pulmonary hypertension.-has initiated or discontinued allergen immunotherapy within 12 weeks of screening. -has smoked within 3 years of screening or has a history of smoking ≥ 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) or equivalent, or a positive urine cotinine test at screening. -has any known malignancy or has a history of malignancy with the exceptions of basal cell carcinoma or squamous cell carcinoma. -has chronic or recurrent infectious disease, including, but not limited to: active tuberculosis.-has a clinically significant, acute respiratory infection within 4 weeks of screening. -has had a substance abuse (drug or alcohol) problem within the previous 3 years.

Keywords: uncontrolled persistent asthma, dyspnea, wheezing
characterization of reverse triggering and other asynchronies in covid-19 patients under invasive mechanical ventilation

Conditions: Mechanical Ventilation Complication

Summary: prospective observational trial in patients admitted to icu diagnosed with covid-19 requiring invasive mechanical ventilation. characterization of reverse triggering asynchrony during the first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation with different outcomes.


Eligibility criteria:
inclusion criteria: * patients under invasive mechanical ventilation more than 24 hours and with a minimum of 48 hours of respiratory signals registered from the ventilator * diagnosis of covid-19 exclusion criteria: * less than 48 hours of data, * age \< 18 years * admitted from other centers under invasive mechanical ventilation.
integration of mental health in hiv clinic to increase the success of arv treatment in plwha in hospitals

Conditions: HIV/AIDS; Depression

Summary: integration of mental health in hiv clinics is needed in order to accelerate fast track 90-90-90 for controlling hiv. symptoms of depression are sometimes difficult to recognize. in people living with hiv (plwha), depression that fails to be recognized and uncontrolled increases the risk of unsuccessful antiretroviral treatment and mortality. the main purpose of this study is to estimate the proportion of depressive disorders in people living with hiv. the study included adult hiv patients aged ≥18 years, both men and women, who had received arv treatment for at least six months, with no history of being diagnosed with depression.

this study was a cross-sectional, non-intervention and multicenter in adults with hiv-aids (plwha) who were treated at a hospital who had received arv treatment for at least six months, without a history of being diagnosed with depression. patients from hiv outpatient clinics in each research hospital were briefed on the study and offered to participate. furthermore, based on the assessment of inclusion and exclusion criteria, plwha who meet the requirements were recruited and data were collected. sociodemographic data, hiv risk factors, risk behaviors, clinical characteristics such as duration of hiv, family history of mental illness, aids-related illnesses, other serious non-aids-related illnesses, treatment (antiretroviral (arv) and non-arv) and history arv treatment response (hiv and cd4 viral load) were collected from each participant. in addition, a rapid screening for depressive disorders was carried out using the patient health questionnaire-9 (phq-9) which was translated and validated in indonesian. the phq-9 questionnaire was filled in by the patient with the assistance of health personnel. the total phq-9 questionnaire score were added up and the severity of depression associated with the score was reported to the patient's physician for further management.

Eligibility criteria:
inclusion criteria: 1. adults aged ≥18 years. 2. hiv positive based on diagnosis standards of care in research hospitals. 3. have received arv treatment for at least six months. 4. without a history of being diagnosed with a depressive disorder beforehand. 5. has been given an explanation before the research and give approval after the explanation. exclusion criteria: 1. being pregnant / nursing. 2. currently undergoing a period of detention. 3. being seriously ill (according to the doctor's justification at the hospital).
clinical course of disease in participants with fa-cm

Conditions: Friedreich Ataxia; Cardiomyopathy

Summary: characteristics and clinical course of disease in participants with cardiomyopathy associated with friedreich ataxia (clarity-fa)

study lx2006-02 is a prospective, longitudinal, low-intervention, multicenter, global study aimed at characterizing the nature and rate of cardiac disease progression in participants with genetically confirmed fa-cm.

Eligibility criteria:
inclusion criteria: * male or female, ages ≥6 years at the time of signing the informed consent (and assent, if applicable). * diagnosis of fa, based on clinical phenotype and genotype (gaa expansion on both alleles), with onset of fa occurring at ≤25 years of age * confirmed left ventricular hypertrophy (lvh) * left ventricular ejection fraction ≥40% exclusion criteria: * presence of other form(s) of cm contributing to heart failure (hf), clinically significant cardiac anatomic abnormality or congenital cardiac malformation, clinically significant coronary artery, uncorrected, hemodynamically significant primary structural valvular disease not due to cm * currently receiving intermittent or continuous intravenous (iv) inotrope infusion, presence of a ventricular assist device, or history of prior heart transplantation * contraindication to cmri * prior organ transplantation * initiation of cardiac resynchronization therapy (crt) within 6 months prior to screening. * history of prior gene transfer or cell therapy. * poorly controlled diabetes (hemoglobin a1c ≥8%) * active hematologic or solid organ malignancy

Keywords: friedreich ataxia fa-cm cardiomyopathy fa cardiac disease
a based on peeg and pet study of anxiolytic treatment to improve cognitive function in patients with alzheimer disease

Conditions: Alzheimer Disease; Cognitive Function

Summary: objective: evaluation the improvement of the cognitive function of tandospirone add-on treatment on patients with ad comorbid anxiety. number of patients: 30 methodology: randomized, open-label, parallel-group assigned interventions: experimental: tandospirone, 30-60 mg/d + donepezil, 10 mg/d; control group: donepezil, 10 mg/d. effect evaluation: primary outcome: change from baseline in adas-cog total score at week 12; npi scale total score at week 12;


Eligibility criteria:
inclusion criteria: * 55-80 years old (including 55 and 80), male or female, sufficient vision, hearing and general health to complete the follow-up and assessment; * patients who were diagnosed with ad according to the dsm-iv; * mmse score \> 10 and ≤ 24; * hama score \> 8; * hamd score ≤ 7; * brain ct or mri supports the diagnosis of ad; * provide written informed consent by the patient himself and his family member or guardian. exclusion criteria: * dementia from any other cause; * brain mri showed that the diameter of hyperintense lesions in t2-flair sequences were larger than 5mm; * patients with significant cardiac, pulmonary, hepatic, renal, or hematologic disease; * any primary neurologic or psychiatric disease other than ad; * mental disorders due to substance abuse; * participation in other clinical studies within the last 30 days; * history of alcohol or substance abuse or dependence within the past year; * pregnant or breastfeeding, or of child-bearing potential during the study.

Keywords: alzheimer disease cognitive function tandospirone
study of regn3767 (anti-lag-3) with or without regn2810 (anti-pd1) in advanced cancers

Conditions: Malignancies

Summary: the primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (pk) in order to determine the selected dose level(s) for expansion of regn3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma. the primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of regn3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (orr).


Eligibility criteria:
key inclusion criteria: * dose escalation cohorts: patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit and who have not been previously treated with a pd-1/pd-l1 inhibitor. these patients do not require measurable disease * dose expansion cohorts: patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per recist 1.1 or lugano criteria. some patients may have been previously treated with a pd-1 or pd-l1 inhibitor * eastern cooperative oncology group performance status of 0 or 1 * adequate organ and bone marrow function key exclusion criteria: * prior treatment with any lag-3 targeting biologic or small molecule * radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any ae due to radiation * untreated or active central nervous system metastases - ongoing or recent (within 5 years) evidence of significant autoimmune disease * corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug * myocardial infarction within 6 months note: other protocol defined inclusion / exclusion criteria apply
safety and efficacy of eswl for geriatric patients with chronic pancreatitis

Conditions: Chronic Pancreatitis; Geriatric; Extracorporeal Shock Wave Lithotripsy

Summary: pancreatic extracorporeal shock wave lithotripsy (p-eswl) is recommended as the first-line treatment for pancreatic stones. however, how well p-eswl performs in geriatric patients remains unclear. the investigators aimed to evaluate the safety and efficacy of p-eswl for geriatric patients with chronic pancreatitis.

this prospective observational study was conducted in patients with painful chronic pancreatitis who underwent p-eswl. patients aged over 65 years were included in the geriatric group; patients aged under 65 years who underwent p-eswl in the same period were assigned to the control group. for investigation of long-term follow-up, the geriatric group were matched with patients from the control group in a 1:1 ratio. the primary outcomes were p-eswl complications and pain relief. the secondary outcomes included: stone clearance, physical and mental health, quality of life score, and body weight.

Eligibility criteria:
inclusion criteria: * patients with painful chronic pancreatitis and radiopaque stones of ≥5mm. exclusion criteria: * patients with a suspected or established malignant mass or pancreatic ascites, and pregnant patients.
a prospective evaluation of the peri-operative hypoxia in breast cancer

Conditions: Breast Cancer Female

Summary: to understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. to study this, clinical samples (tumor biopsies) will be obtained during the surgery after partial devascularisation (sample b) and stored for future genomic and proteonomic evaluations.

three tumor samples will be obtained after the patient is under anaesthesia, 1. prior to starting surgery (sample a) 2. the middle intra-operative sample, which will be collected when half the tumour has been devascularized (i.e., somewhere midway during the surgery). (sample b) 3. a third post excision (anoxic sample c). these tumour tissue samples will be stored as snap frozen, in rna later and as paraffin sections. to understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. to study this, clinical samples (tumor biopsies) will be obtained during and stored for future genomic and proteonomic evaluations.

Eligibility criteria:
inclusion criteria: 1. clinically diagnosis of breast cancer (by fnac or biopsy) 2. not received any chemotherapy or surgical intervention except core biopsy. 3. planed for breast cancer surgery 4. willing to give consent for the study exclusion criteria: 1. clinically diagnosis of metastatic breast cancer 2. received any anticancer therapy
acam2000® myopericarditis registry

Conditions: Myocarditis; Pericarditis

Summary: the purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions. primary objective: - to document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following acam2000® vaccination. other pre-defined objective: - to look for potential predictive factors for the prognosis of myopericarditis following acam2000® vaccination.

all participants will have received previous vaccination with acam2000 but will not receive any vaccination as part of the registry. all participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).

Eligibility criteria:
inclusion criteria: * individuals who are current or former members of the active duty, reserve, or national guard, from any branch of service * documented vaccination with acam2000® vaccine * meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis. exclusion criteria: * individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the registry.

Keywords: myocarditis pericarditis vaccinia virus acam2000® smallpox vaccine
the impact of granulocyte colony stimulating factor on premature ovarian insufficiency

Conditions: Primary Ovarian Insufficiency; Premature Ovarian Failure

Summary: the goal of this pilot study is to improve ovarian reserve markers in patients with premature ovarian insufficiency. the main question it aims to answer is: - will treatment with g-csf allow improvement in markers of ovarian reserve?

the research team hypothesize that treatment of premature ovarian insufficiency patients with g-csf to mobilize bone marrow hematopoietic stem cells will allow for improved ovarian reserve markers including antral follicle count, anti-mullerian hormone (amh) levels and gonadotropin (fsh) levels. the research team anticipate these outcomes: * primary outcome: decreased serum fsh and increased amh levels and u/s measurement of increased antral follicle count (afc) * secondary outcome: improved ovarian response in ivf cycles if bafs develop, and spontaneous or ivf pregnancy.

Eligibility criteria:
inclusion criteria: * women ages 25-40 * woman who meet criteria for poi defined as afc \ 30 iu/l. there may also be associated symptoms of the menopause such as hot flushes, night sweats, insomnia and vaginal dryness. * women who are not taking any other medical or fertility treatments except natural estrogen to stop hot flushes. * those who are provided with informed consent. exclusion criteria: * women with age \> 40 * women with history of autoimmune disorders * women with a history of hematopoietic cell malignancies * women with sickle cell disease * women with any other comorbidities that would preclude infertility treatment and pregnancy such as hiv/aids, hepatitis b or c, breast cancer or body mass index (bmi) \>40.

Keywords: filgrastim granulocyte colony stimulating factor premature ovarian insufficiency neupogen
safety and efficacy of bimatoprost ophthalmic solution in increasing eyelash prominence

Conditions: Eyelash Hypotrichosis

Summary: this study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence


Eligibility criteria:
inclusion criteria: * female caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes * eyelash prominence assessment of minimal or moderate exclusion criteria: * any eye disease or abnormality * any permanent eyeliner or eyelash implants of any kind * any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry * any use of prescription eyelash growth products * any use of over the counter eyelash growth products during the 6 months prior to baseline * any use of treatments that may affect hair growth during the 6 months prior to baseline