Kornimate/medical-research-clean huggingface dataset:
guided self-help for depression in parkinson's disease

Conditions: Depression; Parkinson's Disease

Summary: the purpose of this project is to develop and pilot-test a guided cognitive-behavioral self-help program for mild-to-moderate depression in parkinson's disease (dpd). we will pilot-test the guided self-help treatment on 20 people with pd and their caregivers. the manual will be revised based on participant feedback. several feasibility measures regarding the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness, adherence) will also be assessed. moreover, preliminary estimates of effect size for this guided self-help program will be calculated and used in future research. we hypothesize that people with pd will report decreases in depression, anxiety, and negative thoughts and improvements in quality life and sleep and that caregivers will report decreases in burden after participating in the guided self-help program

to our knowledge, cognitive-behavioral self-help interventions remain unexplored for depression in pd to date. the results of this study will be used to support future treatment development efforts for depression and other psychiatric complications in pd that may improve the access to and quality of mental health care in this medical population.

Eligibility criteria:
inclusion criteria: 1. previous diagnosis of parkinson's disease by a general neurologist or movement disorders specialist 2. clinically significant depression as determined by study staff 3. 35-85 years old 4. stable medication regimen ≥ 6 weeks 5. no change in mental health treatment in past 2 months _ exclusion criteria: 1. severe depressive symptoms 2. suicidal plans or intent 3. significant cognitive impairment 4. significant motor fluctuations (i.e., ≥ 50% of the day) 5. unstable medical conditions 6. receiving cbt elsewhere

Keywords: depression parkinson's disease cognitive-behavioral treatment
validation of novel predictive score for patients with spinal metastases

Conditions: Spinal Metastases

Summary: the investigators are prospectively validating a prognostic clinical tool that uses a patient's modified bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine.

recently, the investigators proposed a clinical prediction score that used a patient's modified bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. this prognostic utility was developed using one-year mortality as the sole outcome measure. while the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. to further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum 3. able to consent for themselves at the time of the intake evaluation 4. speaks english exclusion criteria: 5. primary bone tumors or leukemia 6. metastases to other visceral or skeletal locations, without involvement of the spine or sacrum 7. history of prior spine surgery for metastatic disease
growth and safety clinical trial on a new infant formula

Conditions: Weight Gain

Summary: the aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. in this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. a reference group of human milk-fed infants will also be enrolled. this study is designed in accordance with good clinical practice guidelines and the requirements of the code of federal regulations, 21cfr106.96. this study allows caregivers to participate completely from the comfort of their own home.


Eligibility criteria:
inclusion criteria: * normal term infant (37-42 weeks gestation at birth) * infant \<15 (+3) days of age at first study feeding, birth constitutes day 0 * infant birth weight of ≥2500 g (5.5 lbs.) * healthy infant * caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding) * caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of aes) * caregiver willing and able to sign informed consent exclusion criteria: * infant born in multiple birth (i.e., twins, triplets, etc.) * infant born with medical complications (e.g., neurological, cerebral palsy, etc.) * infant with family history (parents or siblings) of confirmed milk or soy allergies * infant with failure to thrive, fever, any gi tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth * caregiver intent to feed non-study formula or solid food during the study

Keywords: infant formula in-home
prophylaxis of venous thromboembolism after bariatric surgery

Conditions: Morbid Obesity; Thromboembolism; Bypass Complications

Summary: this study is a prospective evaluation of the relationship between lean body weight and anti-xa activity and 5700 international units (iu) nadroparin 4 hours after subcutaneous administration in morbidly obese patients after bariatric surgery.

there is no guideline for postoperative thromboembolic prevention in morbidly obese patients. the investigators goal is to examine which dose of nadroparin is effective.

Eligibility criteria:
inclusion criteria: * approval for roux-en-y gastric bypass * total body weight \> 140 kg exclusion criteria: * renal impairment (gfr \ 150 micromol/ml) * coagulation disorders * use of vitamin k antagonists (such as acenocoumarol) pregnancy

Keywords: nadroparin anti-xa activity
radioaerosol pulmonary deposition during asthma exacerbation through noninvasive ventilation

Conditions: Asthma

Summary: despite the physiologic and clinical effects provided by coupling nebulization with noninvasive ventilation in asthma exacerbation, there are few and controversial studies reported in the literature.

reduced work of breathing, increased oxygenation and increased in expiratory peak flow (epf) and forced expiratory volume in the first second (fev1) are benefits of noninvasive ventilation (nv) in the treatment of asthma. despite these clinical improvements attributed to nv during asthma exacerbations and the well-established effects of nebulization, there are few studies in the literature coupling both therapeutic resources. in addition to this, no studies on scintigraphic analysis of radioaerosol deposition coupled with nv in asthmatics have published. a previous study was published by our group, but involved healthy subjects.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of moderate to severe asthma (fev1 \< 60 % of predicted values) * breathing rate \> 25 bpm * history of asthma for at least 1 year * duration of current asthma attack of \< 7 days * reversibility of fev1 of at least ≤ 10% after the administration of bronchodilator drugs exclusion criteria: * current smoker * presence of cardiopulmonary disease (copd, pneumonia, heart failure, myocardial infarction, pneumothorax) * hyperthermia * indication of intubation and invasive mechanical ventilation; * hemodynamic instability (heart rate \> 150 bpm and systolic blood pressure \< 90 mmhg) * cardiac arrhythmia * changes in consciousness * pregnancy * contraindications to use nv

Keywords: asthma status asthmatics
study of bioavailability, pharmacodynamics and safety of shr-1209 administered by single subcutaneous injection at different sites in healthy volunteers

Conditions: Hypercholesterolemia and Hyperlipidemia

Summary: in order to meet the preferences and needs of different patients for injection sites and improve the medication compliance of patients, it is planned to compare the bioavailability, pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection sites for administration.


Eligibility criteria:
inclusion criteria: 1. understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent; 2. the age on the date of signing the informed consent must be ≥18 years old and ≤55 years old; 3. body mass index (bmi) at screening period must be ≥18.5 kg/m2 and \<30.0 kg/m2, weight of male must≥ 50.0 kg and \<90.0 kg, and female≥ 45.0 kg and \<90.0 kg; 4. the subjects and their female partners are willing to have no reproductive plan from 2 weeks before screening to 6 months after the administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum. exclusion criteria: 1. history of the following diseases or treatments: diseases that affect drug absorption, distribution, metabolism, and excretion determined by the investigator; serious infection within 3 months before screening; history of drug allergy or atopic allergic disease (asthma, urticaria). 2. any one of the following tests at screening period or baseline period: human immunodeficiency virus antibody (hiv-ab), syphilis serological examination, hepatitis b virus surface antigen (hbsag), hepatitis c virus antibody (hcv-ab) positive; positive blood pregnancy test. 3. general situation: have a history of drug use or drug abuse; women who are pregnant or breastfeeding. 4. subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
stereotactic radiotherapy for renal cancers

Conditions: Renal Cancer

Summary: stereotactic radiotherapy is a technique that allows the delivery of a high dose of radiation over few fractions (3-6) with great precision. it thus allows "tumor ablation" and optimal preservation of healthy tissues. initially developed in small-sized (\<5 cm) lung cancers this technique it gives results very close and or even equivalent to those of surgery. stereotactic radiotherapy of brain metastases of renal cancers has shown that high doses of radiation allows local control in 90 to 98% of cases. a study conducted in sweden (wersall et al.) underline the interest to develop stereotactic radiotherapy in primary renal tumors. in cleveland (usa) two phase i studies are already underway. the investigators propose to develop a phase i study for tumors of less than 4 cm. as found in lung cancers, stereotactic radiotherapy can provide a non-invasive, painless and rapid (4 to 5 fractions) method for the treatment of renal cancers with a high rate of local control. the primary objective is to define the maximal tolerated dose for one fraction in stereotactic mode of renal tumors ≤ 4 cm in length using an a four-step dose increase: * step 1: 4 x 8 gy. * step 2: 5 x 8 gy. * step 3: 4 x 10 gy. * step 4: 4 x 12 gy. the patients will be followed during treatment with evaluation of acute toxicities before each session, then at 15 days, 6 weeks, 3 months, 9 months, 12 months, and then every 6 months for a total duration of 5 years after treatment.


Eligibility criteria:
inclusion criteria: * patient aged over 75 years with an operable renal tumor or patient with inoperable renal tumor irrespective of age, or patient with metastatic renal tumor and indication for nephrectomy. * histologically-confirmed renal carcinoma less than or equal to 4 cm * tumor that is visible and measureable on abdominal scanner and/or mri (magnetic resonance imaging) * karnofsky performance status ≥ 60% exclusion criteria: * patient with only one kidney and renal cancer * patient not able to cooperate during treatment * previous history of abdominal radiation therapy * tumor having infiltrated the renal pelvis * polycystic kidney disease * previous history of intestinal inflammatory disease such as ulcerative colitis or crohn's disease * renal insufficiency (creatinine clearance \<30 ml/mm evaluated by dtpa (diethylenetriamine pentaacetic acid ) scintigraphy) * uncontrolled hypertension (sbp(systolic blood pressure) above 160 mmhg dbp(diastolic blood pressure) above 100 mmhg with antihypertensive treatment) * non primary lesions (benign lesions such as angiomyolipoma, renal metastases,...) * antineoplastic and/or antiangiogenic treatment in the month preceding radiotherapy * progressive cancer other than renal cancer at time of inclusion with the exception of in situ cervical carcinomas, basal cell carcinoma of the skin, and non-metastatic prostate cancer controlled without hormone therapy * participation in another ongoing study that may interfere with the present study

Keywords: renal cancer stereotactic radiotherapy
theory-based obesity intervention program for women

Conditions: Obesity

Summary: the aim of this study is to examine the effect of education and counseling given to women according to the theory of planned behavior on weight management. this study will be conducted as a single-blind randomized controlled study consisting of intervention and control groups. a total of 78 overweight and obese women included in the study. the participants assigned to either of the groups by the block randomization method. a training program consisting of a total of five sessions applied to the intervention group, and counseling will be provided for 6 months. the data will be analyzed with statistical package for social sciences (spss) 22.0 package program.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * being a woman in the age group of 18-49 years * having a body mass index (bmi) of 25.0-30.0 kg/m2 (overweight) or \>30.0 kg/m2 (obese) * not going through menopause * not having diabetes * not having thyroid disease * not using hormonal contraceptive pills * not having polycystic ovarian disease * not having a metabolic disease * not having cushing's syndrome * not having a disease that prevents physical activity * not having hypertension * not being pregnant or breastfeeding * owning and using a smart phone * having a mail account in google and being able to use it exclusion criteria: * women who do not meet the inclusion criteria * not volunteering to participate in the study * women with communication problems * women who did not give consent at any stage of the study and who quit the study

Keywords: obesity women health behaviors theory of planned behavior
a comparative study of kso-0400 in bph patients with luts

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: the objective of this study is to evaluate the efficacy and safety of kso-0400 compared to placebo for the treatment of luts caused by bph.


Eligibility criteria:
inclusion criteria: * bph patients with luts exclusion criteria: * patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia * patients with prostate cancer or suspected prostate cancer * patients who have any clinically relevant cardiovascular, hepatic or renal disorder

Keywords: benign prostatic hyperplasia i-pss α1a-ar antagonist
systolic hypertension in europe placebo-controlled trial

Conditions: Isolated Systolic Hypertension

Summary: the syst-eur trial is a concerted action of the european community's medical and health research programme. the trial is carried out in consultation with the world health organization, the international society of hypertension, the european society of hypertension and the world hypertension league. syst-eur is a multicentre trial designed by the european working party on high blood pressure in the elderly (ewphe), to test the hypothesis that antihypertensive treatment of elderly patients with isolated systolic hypertension results in a significant change in stroke morbidity and mortality. secondary endpoints include cardiovascular events, such as myocardial infarction and congestive heart failure. to be eligible patients must be at least 60 years old and have a systolic blood pressure averaging 160-219 mmhg with a diastolic pressure less than 95 mmhg. patients must give their informed consent and be free of major cardiovascular and non-cardiovascular diseases at entry. the patients are randomized to active treatment or placebo. active treatment consists of nitrendipine (10-40 mg/day), combined with enalapril (5-20 mg/day) and hydrochlorothiazide (12.5-25 mg/day), as necessary. the patients of the control group receive matching placebos. the drugs (or matching placebos) are stepwise titrated and combined in order to reduce systolic blood pressure by 20 mmhg at least to a level below 150 mmhg. morbidity and mortality are monitored to enable an intention-to-treat and per-protocol comparison of the outcome in the 2 treatment groups.


Eligibility criteria:
inclusion criteria: * at least 60 years old. * sitting systolic blood pressure on masked placebo, during run-in phase of 160 to 219 mmhg, with a sitting diastolic blood pressure below 95 mmhg and a standing systolic blood pressure of at least 140 mmhg * informed consent must be obtained exclusion criteria: * systolic hypertension is secondary to a disorder that needed specific medical or surgical treatment. * retinal haemorrhage or papilloedema; * congestive heart failure * dissecting aortic aneurysm * serum creatinine concentration at presentation of 180µmol/l or more. * history of severe nose bleeds. * stroke or myocardial infarction in the year before the study. * dementia. * substance abuse. * any disorder prohibiting a sitting or standing position. * any severe concomitant cardiovascular or non-cardiovascular disease.

Keywords: cardiovascular complications clinical trial elderly isolated systolic hypertension stroke
artificial intelligence-based prediction of radio-cephalic arteriovenous fistula maturation using preoperative duplex examination

Conditions: Renal Insufficiency, Chronic; Arteriovenous Fistula; Artificial Intelligence (AI); Machine Learning

Summary: the goal of this observational study is to assess the efficacy of ai-driven models in analyzing comprehensive ultrasonographic variables across multiple forearm locations to predict successful avf maturation. the main question it aims to answer is: can ai-driven models analyzing comprehensive ultrasonographic variables accurately predict the successful maturation of arteriovenous fistulas (avfs)? participants who underwent radiocephalic arteriovenous fistula (avf) creation had their preoperative ultrasonographic data analyzed using ai-driven models to predict successful avf maturation over a four-year retrospective period.


Eligibility criteria:
inclusion criteria: * patients who underwent rcavf due to advanced chronic kidney disease from 2018 to 2022 exclusion criteria: * patients who did not have follow-up data available

Keywords: preoperative ultrasound mapping radiocephalic arteriovenous fistula renal dialysis artificial intelligence machine learning chronic kidney disease
temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma

Conditions: Glioblastoma Multiforme/Anaplastic Astrocytoma

Summary: rationale: drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. radiation therapy uses high-energy x-rays to kill tumor cells. specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. giving chemotherapy together with radiation therapy may kill more tumor cells. purpose: this phase i trial is studying the side effects and best dose of temozolomide when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.

objectives: primary * to determine the maximum tolerated dose of temozolomide when given in combination with hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma. secondary * to determine the time to neuroradiological evidence of tumor recurrence or progression in patients treated with this regimen. * to determine the survival time of patients treated with this regimen. * to determine the time spent in a karnofsky performance status of 60-100%. outline: this is a dose-escalation study of temozolomide. beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once daily for 5 weeks. beginning 1 week after starting temozolomide, patients also undergo hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a week for 3 weeks. after completion of study treatment, patients are followed at 1 month, 2 months, and 3 months, and then every 3 months thereafter.

Eligibility criteria:
inclusion criteria: * patients who have de novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma of the brain, not involving the brain stem or optics chiasm, diagnosed following biopsy or tumor removal. * age \> 18 years * given written consent * adequate bone marrow reserve(hemoglobin \> 10 grams, absolute neutrophil count \> 1500 / mm3, platelets \> 100,000/ mm3) * normal renal function(bun \< 24 mg/dl, creatinine \< 1.3 mg/dl) * normal liver function(total bilirubin \< 1.5 mg/dl, sgpt/alt \< 60 u/l) exclusion criteria: * have a karnofsky score of \< 60 \[appendix b\] or age \< 18 years. * prior chemotherapy and/or radiotherapy of their glioblastomamultiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma. * tumors located in the brainstem or optic chiasm. * prior radiation therapy to the brain * prior chemotherapy within the past 6 weeks.

Keywords: adult giant cell glioblastoma adult gliosarcoma adult anaplastic astrocytoma adult glioblastoma gbm/aa