Kornimate/medical-research-clean huggingface dataset:
culturally adapted suicide prevention intervention for older adults

Conditions: Suicidal Ideation

Summary: determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults (e-cmap) with suicidal ideation

suicide is a serious public health concern. each year more than 800,000 people worldwide die due to suicide. most of these (79%) are in the low and middle-income countries (lmic), with an increased risk of suicide in ageing. primary objective: to assess the effectiveness of e-cmap compared to treatment as usual (tau) as measured by reduction in suicidal ideation third month post-randomization with beck scale for suicidal ideation (bsi) (beck \& steer, 1991) secondary outcomes: the two groups will be compared on hopelessness, depression, quality of life, coping skills, participant satisfaction, health/social care usage, and episodes of self-harm. all variables known to be related to suicide risk. the study will be carried out in two stages. first stage will be cultural adaptation and refinement of the intervention and second stage will be feasibility randomised control trial (rct). stage 1: in the first stage, the adaptation of the intervention for suicidal ideation in older adults will be carried out by a group of experts including a master trainer, a bilingual health expert, mental health professional potential user (i.e., older adults with suicidal ideation), and a senior therapist through discussion groups. stage 2: feasibility randomized controlled trial (rct) after adaptation, the intervention will be tested in a multicenter rct to determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults/elderly (e-cmap) with suicidal ideation.

Eligibility criteria:
inclusion criteria: in the context of this study, suicidal ideation is defined as; "passive thoughts about wanting to be dead or active thoughts about killing oneself, these thoughts may include plan but not accompanied by preparatory behavior" (griffin et al., 2020) * 50 years and above * has recent history of experiencing suicidal ideation * participants living within the catchment area of the participating practices and hospitals. * capacity to give informed consent. exclusion criteria: * unable to provide consent due to severe mental or physical illness. * unlikely to be available for outcome assessments (temporary residence)

Keywords: suicidal ideation, self-harm older adult elderly ecmap pakistan lmic
study of cs3006 in subjects with locally advanced or metastatic solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors

Summary: this is a multicenter, open label, sequential-cohort, dose escalation \& expansion phase i study to evaluate the clinical safety, tolerability, pk, and preliminary efficacy of cs3006 and to establish the maximum tolerated dose (mtd）, if any, recommended phase ii doses (rp2ds) and regimen of cs3006. the study is composed of two parts: part 1 for dose escalation and part 2 for dose expansion.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent for the trial. 2. subjects must have a histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable. 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. life expectancy ≥ 12 weeks. 5. able to swallow and retain oral medication. 6. subject must have adequate organ function. 7. use of effective contraception. exclusion criteria: 1. subjects receiving cancer therapy at the time of enrollment. 2. has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days of the first dose of investigational product administration or who has not recovered from adverse events due to a previously administered agent. 3. previous treatment with a mek inhibitor. 4. use of any investigational anti-cancer drug within 28 days before the first investigational product administration. 5. current use of a prohibited medication. 6. presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs. 7. known brain metastasis or other cns metastasis that is either symptomatic or untreated. 8. primary malignancy of the central nervous system. 9. evidence of severe or uncontrolled systemic diseases. 10. subjects with clinically significant cardiovascular disease. 11. human immunodeficiency virus (hiv) infection. 12. subjects with active hepatitis b or c infection. 13. known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients. 14. concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol. 15. unwillingness or inability to follow the procedures outlined in the protocol. for more information regarding trial participation, please contact at cstonera@cstonepharma.com
improving insulin sensitivity by non-invasive brain stimulation

Conditions: Insulin Resistance; Transcranial Direct Current Stimulation; Obesity; Diabetes; Magnetic Resonance Imaging

Summary: efforts in curing and preventing obesity and type 2 diabetes (t2d) have been elusive thus far. one reason for that is the lack of understanding of the role of the brain in the development and treatment of the disease. in recent studies, the hypothalamus was identified as part of a brain network including higher cognitive regions that is particularly vulnerable to insulin resistance. furthermore, the central insulin response in this network predicted food craving and hunger. in this project, transcranial direct current stimulation (tdcs) is implemented as a tool to stimulate brain networks. the investigators hypothesize that stimulating the hypothalamus-cognitive network will enhance insulin sensitivity and reduce food intake, food craving and hunger. furthermore, the project will provide the unique opportunity to investigate novel mechanisms of insulin resistance in participants who have been extensively metabolically characterized.

objectives the overarching aim of the study is to stimulate the hypothalamus-cognitive brain network to improve insulin sensitivity and eating behavior. specific objectives 1. implement tdcs stimulation compared to sham stimulation in overweight and obese adults to assess the impact on eating behavior, cognition and metabolism. 2. evaluate whether 3-day non-invasive brain stimulation of the hypothalamus-cognitive network has a causal effect on metabolism. 3. evaluate whether 3-day non-invasive brain stimulation has a significant effect on brain functional connectivity and diffusion parameters.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 25.5 and 39.5 kg/m2 * age between 20 to 66 years of age * waist circumference ≥ 80 cm for women, ≥ 94 cm for men exclusion criteria: * insufficient knowledge of the german language * persons who cannot legally give consent * pregnancy or lactation * history of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures) * taking psychotropic drugs * previous bariatric surgery * acute infection within the last 4 weeks * hemoglobin values less than 12g/dl for women, less than 14 g/dl for men * current participation in a lifestyle intervention study or a pharmaceutical study * contradictions to a mri measurement (e.g. metal implants)
evaluation of the humoral and tumoral molecular alteration profile of brain metastases

Conditions: Brain Metastases

Summary: the purpose of the study is to determine in brain metastases and according to feasibility in liquid biopsies: * molecular alterations including in particular mutations, amplifications, copy number gene variants and fusion transcripts identified by high-throughput sequencing; * the rate of variation either in gain or in loss of expression of the different messenger ribonucleic acids by analysis of the transcriptome; * epigenetic alterations by methylation of deoxyribonucleic acid clusters by methylome chips.

this is a single-center, prospective, interventional, exploratory study aimed at comparing the molecular alteration profile of liquid biopsies (blood and lumbar puncture) to that of brain metastases. the population eligible for the study will consist of any patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision. the study consists of comparing, between brain metastases and liquid biopsies (blood and lumbar puncture), the profiles of genomic, post-genomic and epigenetic alterations as well as the mutational load. to do this, the study only requires a lumbar puncture and a blood test.

Eligibility criteria:
inclusion criteria: * patient aged 18 or over; * patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision (contrast enhancement of at least 1 cm); * patient able to understand the information related to the study and to read the information leaflet; * patient having signed a written informed consent to participate in the study. exclusion criteria: * patient with a medical contraindication to surgery and anesthesia; * patient whose anatomical location of the cerebral metastasis contraindicates wide resection; * patient with a contraindication to performing a lumbar puncture; * pregnant, parturient or breastfeeding women; * patient participating in another clinical trial, or in a period of exclusion from another clinical trial; * patient under guardianship or curatorship, or under a regime of deprivation of liberty; * patient not benefiting from a social security scheme.
effects of obesity surgery on renal function

Conditions: Impaired Renal Function

Summary: increasing risk of impaired renal function as a result of obesity is well known. early data has postulated that weight loss might improve kidney function, but the evidence is rather limited due to the difficulties in measuring glomerular filtration rate(gfr) after weight loss. cystatin c, gfr measurement using cockcroft-gault (ccg) and modification of diet in renal disease (mdrd) equations, have all yield conflicting results after weight loss surgery. the study aim to assess: 1. use of 51cr-edta clearance as the methodological gold standard in evaluating changes in renal function before and after weight loss surgery. 2. the reliability of using mdrd, ccg and cystatin c in measuring gfr after weight loss surgery 3. the differences in alterations in renal function dependent on the surgical procedures( gastric bypass, gastric band, sleeve gastrectomy). 4. the use of urine albumin/creatinine ratio in detecting alterations in microalbuminuria.

this is a prospective study on obese human subjects undergoing bariatric surgery. forty-five patients due to undergo gastric bypass (n=15), gastric banding (n=15), and gastric sleeve surgery (n=15) will be recruited. subjects will be screened prior to entry into the study with full history, examination, routine bloods (fbc, u+e, liver function tests, and glucose). 1. blood samples and 24h urine specimens are taken at four time points: preoperatively as well 6 weeks, 6 and 12 months postoperatively. 2. the following methods of gfr assessment will be executed the same time point: measurement of serum creatinine concentration, calculation of the abbreviated and extended mdrd formulae, ccg, creatinine clearance, serum cystatin c concentration and the 51chromium-edta clearance. inclusion criteria 1. patients with a bmi of \>35kg/m2 approved for obesity surgery based on the nice criteria. 2. patients with a gfr \<60 ml/min/1.73 exclusion criteria 1. allergy to chromium

Eligibility criteria:
inclusion criteria: * patients with a bmi of \>35kg/m2 approved for obesity surgery based on the nice criteria. * patients with a gfr \<60 ml/min/1.73 m2 exclusion criteria: * allergy to chromium

Keywords: obesity related glmerulopathy 51 cr-edta clearance impaired renal function gastric band gfr measurement gastric bypass sleeve gastrectomy
aflibercept in polypoidal choroidal vasculopathy

Conditions: Neovascular Macular Degeneration

Summary: to collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration


Eligibility criteria:
inclusion criteria: * signed informed consent * men and women ≥50 years of age * diagnosis of symptomatic macular polypoidal choroidal vasculopathy (pcv) in the study eye established by indocyanine green angiography(icga) at the study center * greatest linear dimension of the lesion of \< 5400 mm (approximately, 9 macular photocoagulation study disk areas), assessed by icga. * an early treatment diabetic retinopathy study (etdrs) bcva of 73 to 24 letters in the study eye. exclusion criteria: * prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3 months prior to study entry * any prior use of intraocular anti vascular endothelial growth factor (anti-vegf)agents in the study eye, or systemic use of anti vegf products within 3 months prior to study entry * prior macular laser treatment in the study eye including photodynamic therapy (pdt) * history of allergy to fluorescein used in fluorescein angiography, iodine and/or indocyanine green. * history of allergy to aflibercept, verteporfin, or their excipients.

Keywords: pcv
ischemic preconditioning as an intervention to improve stroke rehabilitation - froedtert

Conditions: Stroke Rehabilitation; Ischemic Preconditioning; Physical and Rehabilitation Medicine

Summary: this study will be the first study to use ischemic preconditioning (ipc) as an intervention to improve stroke rehabilitation. ipc is a well studied, well tolerated intervention which has been shown to improve regional blood flow, motor neuron excitability and muscle function in multiple patient groups and in young, healthy subjects. because ipc targets three physiological systems which are all affected by stroke, we hypothesize that repeated bouts of ipc during the first days to months following stroke (when the majority of recovery occurs) will make traditional rehabilitation strategies more effective.


Eligibility criteria:
inclusion criteria: 1. be between the ages of 40-80 2. able to give informed consent. 3. be \< 6 months post diagnosis of unilateral cortical stroke and 4. have residual leg paresis. exclusion criteria: 1. chronic low back or hip pain 2. substance abuse 3. head trauma with loss of conciousness in last 6 months 4. neurodegenerative disorder 5. participant taking any medication or supplement that adversely interacts with nitroglycerin (exclusion from nitro administration only, applies to outpatients only) 6. participant has a known allergy to nitroglycerin (exclusion from nitro administration only, applies to outpatients only) 7. resting systolic blood pressure \< 90mmhg (exclusion from nitro administration only, applies to outpatients only) 8. any condition where knee extension contractions are contraindicated 9. people who are unable to follow multi step commands. 10. pregnancy (dxa scan exclusion only) 11. history of major psychiatric disorder 12. participant has had a myocardial infarction in the last year 13. participant has stage ii hypertension (bp\>160/100) 14. participant is unable to contract knee muscles 15. participant is unable to sit upright for 2 hours 16. participant has a resting heart rate \>100 beats per minute 17. history of multiple strokes
assessment of the lipid lowering effect of rosuvastatin compared to atorvastatin in subjects with coronary heart disease

Conditions: Coronary Heart Disease

Summary: the purpose of this study is to compare the efficacy between two lipid lowering treatments, rosuvastatin (10-40 mg) and atorvastatin (20-80 mg) in reducing low-density lipoprotein cholesterol (ldl-c) levels after 16 weeks of treatment in patients with coronary heart disease


Eligibility criteria:
inclusion criteria: * 18 years or older, established coronary heart disease with a previously performed pci, previous treatment with clopidogrel, ongoing statin treatment, ldl-c\>2.9 mmol/l, signed informed consent. exclusion criteria: * ongoing treatment with clopidogrel for more than 12 weeks after randomisation, hypersensitivity to any of the study drugs, active liver disease, moderate or severe renal impairment, hereditary for or known muscular or neuromuscular disease and/or increased serum ck, pregnancy or lactation or of childbearing potential not practising an adequate method of contraception, use of concomitant medication with possible interaction with

Keywords: coronary heart disease percutaeous coronary intervention (pci)
clinical evaluation of a paediatric sleep diagnosis technology

Conditions: Sleep Apnea

Summary: the objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population. the study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.

the objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population. the study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography. patients who are referred to the clinic will spend one night's sleep in the clinic. they will wear a polysomnography system (current goldstandard) and the novel device. at the end of the trial, we will compare the diagnosis results from both systems.

Eligibility criteria:
inclusion criteria: * children older than one year old * children who have been referred to a sleep clinic due to suspicion of sleep apnoea. exclusion criteria: * patients whose parents/legal guardians/carers are not fluent in english, or who have special communication needs. * known allergy to the adhesive dressing. * patients with physical or mental impairments who would be too distressed with additional sensors on themselves. * patients with not enough space on the neck area to fit the sensor. * clinical problem in the area in which the device will be attached, eg skin condition
efficacy and safety evaluation of pegamotecan (peg-camptothecin) in advanced or metastatic soft tissue sarcoma

Conditions: Sarcoma, Soft Tissue

Summary: the purpose of this study is to evaluate the safety and efficacy of pegamotecan (peg-camptothecin) in patients with advanced or metastatic soft tissue sarcoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease. * target tumors outside prior radiation field(s). * eastern cooperative oncology group (ecog) performance status of 0-2. * adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count. * adequate renal function * adequate liver function * no history of hemorrhagic cystitis or evidence of microscopic hematuria * capable of understanding the protocol requirements and risks and providing written informed consent. * either 0 or 1 prior chemotherapy regimens exclusion criteria: * subject has a diagnosis of gastrointestinal stromal tumors. * concurrent serious medical illness unrelated to tumor within the past 6 months. * known chronic infectious disease, such as aids or hepatitis. * positive screening pregnancy test or is breast-feeding. * a female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this study. * receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide field radiation within the previous 4 weeks. * history of another active malignancy (except non-melanoma skin cancer and carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for the last 2 years. * known or clinically suspected brain metastases. * received more than one prior treatment regimen (excluding adjuvant or neoadjuvant therapy) for soft tissue sarcoma. * received any investigational drug within the last 30 days. * not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy or radiation therapy. * received a prior camptothecin analog (e.g., topotecan, irinotecan).

Keywords: soft sarcoma metastatic
modifications to radical prostatectomy: feasibility study

Conditions: Prostate Cancer

Summary: this study aims to determine whether surgeons at memorial sloan-kettering cancer center are able to randomize patients to test modifications of surgery to remove the prostate. surgery to remove the prostate is known as a "radical prostatectomy". surgeons know many things about the best way to do a radical prostatectomy. however, there is disagreement about some aspects of surgery. two modifications of surgery to remove the prostate (radical prostatectomy) identified for this study include irrigation, and fascial suturing. two aspects of the operation may vary, fascial suturing and urethral irrigation. for each aspect, surgeons will use their clinical judgment as to the best interests of the patient. in other words, if there are clear reasons to use or avoid a fascial suturing approach, the surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid irrigating the urethra, the surgeon can make the appropriate clinical decision. if the surgeon is unsure as to which approach to take, then the randomization scheme will be followed. all of the surgeons who are taking part in this study have used these techniques at different times. however, they are unsure as to the best approach. sometimes, they use different treatments with different patients. irrigation. cancer cells can spill during surgery and this can cause cancer to return ("recur"). some surgeons believe that "irrigating" could help stop spilling of cancer cells. "irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. as a result, surgeons vary as to how they irrigate. in this study, we will examine irrigation of the urethra. this is the part of the body that carries urine from the bladder to the penis. fascial suturing. surgeons believe that what happens to the urethra can affect the risk of incontinence. this is when a patient cannot control urine, and drips or leaks urine. one idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure.


Eligibility criteria:
inclusion criteria: * patients scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at mskcc. exclusion criteria: * prior treatment for prostate cancer: radiation, hormonal therapy, chemotherapy or focal therapy.

Keywords: prostate radical prostatectomy urethral irrigation fascial suturing 09-051