Kornimate/medical-research-clean huggingface dataset:
mr-guided focused ultrasound plus gcase

Conditions: Parkinsons Disease

Summary: the goal of this study is to establish safety and feasibility of intracerebral delivery of gcase via mrgfus. this technique may offer potential benefits given the exposure of the putamen to gcase in animal models has been shown to be efficacious in improving parkinson's disease pathology and phenotype.

this is a two-arm, open-label, intervention only phase i/ii clinical study. one arm of the study will enroll seven (7) gba pd patients and the other arm seven (7) idiopathic pd patients. during the intervention phase, the first four subjects of each arm will receive three transcranial bilateral putamenal gcase at 30 iu/kg iv every two weeks, followed by 60 iu/kg in the next three subjects. following three treatments in this study, the subjects will be followed for twelve months.

Eligibility criteria:
inclusion criteria: * men or women between age 35 and 80 years, inclusive. * able and willing to give informed consent. * diagnosis of pd satisfying mds clinical diagnostic criteria for pd * at least 2 years from initial diagnosis * hoehn and yahr stage 1-3 on pd medication * dopaminergic deficit by a positive dat spect scan * on stable regimen of pd medications for at least 90 days prior to the study * american society of anesthesiologists (asa) score 1-3 * harbor at least one gba mutation if enrolled in the gba pd arm or two wild-type gba alleles if enrolled in the idiopathic pd arm exclusion criteria: * positive pregnancy test (for pre-menopausal women). * contraindication to definity ultrasound contrast agent or perflutren (e.g. hypersensitivity, known left or bidirectional cardiac shunt) * contraindication to mri or gadolinium-dtpa (e.g. incompatible device, hypersensitivity) * insulin-dependent diabetes mellitus that is not well-controlled or that in the investigator's opinion precludes participation in the study. * severely impaired renal function with estimated glomerular filtration rate \<30 ml/min/1.73m2 and/or on dialysis. * currently participating in another clinical therapeutic trial * patient receiving bevacizumab (avastin) therapy * subjects with evidence of cranial or systemic infection. * cerebral or systemic vasculopathy. * documented cerebral infarction within the past 12 months or tia in the past 1 month. * contraindication to gcase enzyme therapy, specifically previous hypersensitivity reaction to gcase enzyme therapy * parkinsonism plus symptoms, secondary parkinsonism * previous neurosurgical procedure for pd

Keywords: parkinson's disease glucocerebrosidase gcase
diabetes nutrition algorithm - prediabetes

Conditions: Prediabetes; Diabetes Mellitus Type 2; Obesity; NAFLD; Dyslipoproteinemia

Summary: prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). the investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.

prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). the investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement. the main comparison will assess differences in metabolic outcome due to low-carb or low-fat dietary intervention in short- and long-term design. additionally, the role of pufa will be assessed during long-term intervention to achieve better maintenance of metabolic improvements from the first study phase.

Eligibility criteria:
inclusion criteria: * impaired fasting glucose (ifg) fasting blood glucose 100-126 mg/dl and/or * impaired glucose tolerance (igt) 75 g ogtt 120 minutes: 140-200 mg/dl exclusion criteria: * current pregnancy or breastfeeding * bmi \> 45 kg/m² * diabetes mellitus typ 1 or 2 * serious disease e.g symptomatic coronary heart disease * serious symptomatic malignant disease (weight loss \> 10% within the last 6 month) * severe liver or kidney disease ( an increase in transaminases \> 3 times than the upper limit of the standardized range, gfr \< 50 ml/min/1,73m²) * systemic infection (crp \> 1 mg/dl) * severe mental illness * drug abuse * treatment with steroids * potentially incompliant subjects * exclusion criteria for magnetic resonance tomography * any kind of metal in or on the body: cardiac pacemakers prosthetic heart valves metal prosthesis magnetic implanted metallic parts contraceptive coil metal fragments/ grenade shrapnel fixed braces acupuncture needles insulin pump intraport etc. field strength \> 3 tesla further tattoos, permanent make-up * persons with limited thermosensory or heightened sensitivity to heating * persons where cardiovascular disease cannot be ruled out by examination * persons with heightened sensitivity to loud noise or diseases of the ear * used closed whole body scanner: claustrophobia

Keywords: prediabetes diabetes mellitus type 2 obesity nafld dyslipoproteinemia
effects of acute carbohydrate intake intra-training in crosstraining

Conditions: Recovery

Summary: this study aims to investigate the effect of acute carbohydrate intake during a crosstraining session on exercise-induced muscle damage and the recovery of crosstraining athletes.

carbohydrate intake during exercise could decrease the subjective perceived exertion and promote recovery during high-intensity and intermittent exercises such as crosstraining. nevertheless, despite extensive research on carbohydrate ingestion during exercise across different sports disciplines, its effects have not been investigated in crosstraining sessions. 23 male trained crosstraining athletes will ingest carbohydrates (60g of maltodextrin + fructose, 2:1 ratio) or placebo during a one-and-a-half-hour crosstraining session. the session will consist of a warm-up, a weightlifting part, a strength part, a wod, and an amrap. the rating of perceived exertion (rpe) will be assessed using the validated borg scale at the beginning of the session, after each part of the training, and at the end of the session. doms will be assessed using a visual analog scale at 24 and 48 hours after the crosstraining session.

Eligibility criteria:
inclusion criteria: * age: 18-35 years. * body mass index: 18.5-30 kg/m2. * ability to understand the instructions, objectives, and study protocol. * minimum of 3 years of experience in crosstraining, with at least 6 hours of weekly training over the past 3 months. * resident on the island of tenerife. exclusion criteria: * history of a significant adverse cardiovascular event, renal insufficiency, cirrhosis, eating disorder, weight control surgical intervention, or type 2 diabetes mellitus. * any chronic condition in which the intake of nutritional supplements is not advisable. * any condition that, in the investigator's judgment, would impair the ability to participate in the study or represent a personal risk to the participant. * use of medications that may affect the study results. * unstable body weight for 3 months prior to the start of the study (\> 4 kg loss or gain in - weight). * active tobacco abuse or illicit drug use, or history of treatment for alcohol abuse. * on a special diet or prescribed for other reasons (e.g., celiac disease).

Keywords: sports drink performance concurrent exercise nutrition recovery
renal considerations in the heat stress recommendations (aim2)

Conditions: Hot Weather; Adverse Effect; Kidney Dysfunction; Kidney Injury; Hyperthermia; Dehydration

Summary: an epidemic of chronic kidney disease is occurring in laborers who undertake physical work outdoors in hot conditions. the reason for this is largely unknown, but may be related to kidney dysfunction caused by increases in body temperature and dehydration that elicit oxidative stress and inflammation in the renal tubules. the purpose of this study is to determine whether hydration status modifies the development of renal oxidative stress and inflammation.


Eligibility criteria:
inclusion criteria: * men and women * 18-44 y old * body mass index ≤35.0 kg/m2 * self-reported to be healthy exclusion criteria: * not within defined age range * estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73m2 * body mass index \>35.0 kg/m2 * current or history of any renal disease, heart disease, stroke, immune or autoimmune disease, and/or gastrointestinal disease/surgery * hypertension during screening (systolic blood pressure \>139 or diastolic blood pressure \>89) * using medications that blunt the physiological response to exercise (e.g., beta blockers) * prescription medication with a known side effect of impaired temperature regulation or fluid balance (e.g., diuretics) * positive pregnancy test at any time during the study or breast feeding * current tobacco or electronic cigarette use or consistent use within the last 2 years * answered "yes" to any question on page 1 of the par-q+.
camrelizumab in combination with apatinib and temozolomide as first-line treatment in advanced acral melanoma

Conditions: Acral Melanoma

Summary: it is a rct aimed to evaluate the progression free survival of camrelizumab combined with apatinib and temozolomide as first line therapy in advanced acral melanoma.


Eligibility criteria:
inclusion criteria: * age:≥18 years, male or female. * histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage iii/iv). * has not received any systematic anti-tumor drug treatment. * measurable disease based on response evaluation criteria in solid tumors (recist) 1.1. * ecog 0-1. * adequate organ function. * life expectancy of greater than 12 weeks. * patient has given written informed consent. exclusion criteria: * patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. * known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation. * subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ); * subjects with any active autoimmune disease or history of autoimmune disease uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> nyha ii congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; * received a live vaccine within 4 weeks before the first dose of study medication. * pregnancy or breast feeding. * decision of unsuitableness by principal investigator or physician-in charge.
imaging of tumour microenvironment in patients with oropharyngeal head and neck squamous cell carcinoma using rgd pet/ct imaging

Conditions: Oropharyngeal Squamous Cell Carcinoma

Summary: known risk factors inducing squamous cell carcinomas of the head and neck are tabacco and alcohol intake. however, the incidence of human papillomavirus (hpv) related oropharyngeal carcinomas is increasing. it is known that hpv+ and hpv- tumors have a different reaction to (chemo)radiotherapy. the exact mechanisms underlying these differences is not yet known but might be caused by changes in vascularity. therefore the vasculature is imaged with the help of a study specific gallium-68-dota-(rgd)2 pet/ct scan and a ct perfusion scan.

the incidence of human papilloma virus positive (hpv+) oropharyngeal head and neck squamous cell carcinoma (hnscc) is rising and it has become evident that this type of cancer represents a subgroup of hnscc that is characterized by a more favourable prognosis, mediated by a distinct tumour microenvironment, compared to patients with hpv negative (hpv-) tumours. however, the exact mechanisms underlying this improved treatment outcome and the potential role of the tumour microenvironment are not fully understood yet. imaging of αvβ3 integrin expression will obtain more insight in the differences in tumour microenvironment between hpv+ and hpv- oropharyngeal hnscc. ct perfusion provides additional characterisation of this tumour microenvironment. therefore, these techniques may have the potential to predict response to treatment and might possibly steer treatment decisions in future clinical trials.

Eligibility criteria:
inclusion criteria: * proven squamous cell carcinoma of the oropharynx * p-16 immunohistochemistry analysis * tumour lesion of at least 1.0 cm in diameter * planned chemoradiotherapy as primary treatment * ability to provide written informed consent exclusion criteria: * contra-indications for pet * contra-indications for administration of iodine-containing contrast agents * other serious illness that can affect the scans

Keywords: tumour microenvironment chemoradiotherapy oropharyngeal squamous cell carcinoma human papilloma virus positron emission tomography
safety and efficacy of canaloplasty and non-penetrating deep sclerectomy with phacoemulsification to treat glaucoma and cataract

Conditions: Open Angle Glaucoma; Cataract

Summary: it is a comparative study of safety and efficacy of canaloplasty and non-penetrating deep sclerectomy combined with phacoemulsification to treat glaucoma and cataract. it is a randomised, prospective study.


Eligibility criteria:
inclusion criteria: * co-existing glaucoma and cataract * glaucoma types ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma) * eye with characteristic glaucoma changes (biomicroscopic,visual field) with iop \>16mmhg on medication or without, or iop\<16mmhg on 2 or more medications. * uncontrolled iop * patients not tolerating antiglaucoma medications, * patients with poor compliance * progression in visual field exclusion criteria: * previous surgical glaucoma procedure * previous cataract surgery * visual function under 0,004 * closed angle glaucoma * poorly controlled diabetes mellitus * advanced amd * active inflammatory disease * pregnancy * mental disease or emotional instability, that could

Keywords: canaloplasty non-penetrating deep sclerectomy glaucoma cataract ophthalmology glaucoma surgery
a study to evaluate the safety and pharmacokinetics of two formulations of c1-esterase inhibitor

Conditions: Hereditary Angioedema Types I and II

Summary: a new formulation of berinert (csl830) is being investigated for the management of hereditary angioedema (hae). the main aim of the study is to assess the safety of a single 1500 iu dose of the new formulation of berinert. this study will also look at the pharmacokinetics of csl830 relative to berinert currently on the market.


Eligibility criteria:
inclusion criteria: * healthy subjects without clinically significant medical conditions or laboratory abnormalities * male or female subjects aged 18 to 45 years inclusive, at the time of informed consent * non-smokers * body mass index of 18.0 to 29.0 kg/m2 inclusive exclusion criteria: * previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit. * known or suspected hypersensitivity to the investigational medicinal product (imp), or to any excipients of the imp. * female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit. * alcohol, drug, or medication abuse within one year before the study. * female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile. * participation in another clinical study (or use of another imp) within 30 days (or 5 times the half-life, whichever is longer) before, or during, the study.
a comparative study of sparc's sdp-133 once daily and lumigan in subjects with open angle glaucoma or ocular hypertension

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: to evaluate the efficacy of once daily dosing with sparc's novel ophthalmic formulation of bimatoprost compared with lumigan 0.01% in subjects with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: 1. be male or female, of 18 years of age or older 2. provide signed and dated informed consent in accordance with good clinical practice (gcp) and local legislation prior to any study procedure. 3. have open-angle glaucoma, (with or without pseudo exfoliation, pigment dispersion component) or ocular hypertension in both eyes and likely to be controlled on monotherapy. 4. females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method \[such as condom plus diaphragm with spermicide\], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. a sterile sexual partner is not considered an adequate form of birth control. subjects on hormonal contraceptives must have been on the same hormonal contraceptive for at least one month before the screening and continue throughout the duration of the study. a female is considered of childbearing potential if she has had her first menses and she is either 1. not postmenopausal for at least 12 consecutive months prior to enrollment;(visit 1) or 2. not surgically sterilized by bilateral tubal ligation, or bilateral oophorectomy, or hysterectomy 5. male subjects with partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (eg. condom) if not surgically sterile (ie, vasectomy). 6. be able and willing to follow study instructions and complete all required visits. exclusion criteria: 1. in the opinion of the investigator have uncontrolled or unstable systemic disease (eg, diabetes) which might interfere with the study. subjects with a history of cancer or requiring cancer treatment within the past 5 years. basal cell and its treatment are allowed. 2. current or history of subjects with depression, cerebral or active coronary insufficiency or orthostatic hypotension. 3. (if female of childbearing potential) be pregnant, nursing, or planning a pregnancy from study entry and through the duration of the study. 4. in the opinion of the investigator the subject has clinically relevant, abnormally low or high blood pressure or pulse rate. 5. have any known allergy or sensitivity to the study medications or their components. 6. have any contraindications to bimatoprost therapy. 7. be enrolled in an investigational drug or device study or have participated in such a study within 30 days prior to visit 1. 8. subject who may be involved in any aspect of the trial conduct, may not be an investigator, sub-investigator, or other site staff , or related to any site staff.
insertion of an intrauterine device (iud) after medical abortion

Conditions: Intrauterine Device Expulsion; Medical Abortion; Induced Abortion

Summary: the purpose of this study is to determine the expulsion and continuation rate of an intruterine device (iud) placed immediately after medical abortion. our hypothesis is that immediate-placement of an iud after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6 weeks after pregnancy).

women who seek abortion care often desire more effective or longer- lasting contraception. intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the woman's part to protect her from pregnancy, and are underutilized in the us. we are interested in determining whether placement of an intreatuereine device (iud) at the time of confirming the completion of a medical abortion may have similar expulsion and continuation rates as iuds placed after pregnancy (usually a 4-6 week time period). if this is the case, women may save the time and effort of yet another clinic visit, as well as have immediate protection against pregnancy after their abortion. fda labeling does not specify or restrict time of insertion and therefore this study is in compliance with fda labeling.

Eligibility criteria:
inclusion criteria: * women who completed a medical abortion in the last 14 days * at least 18 years old. * desiring long-term contraception with an iud. * able and willing to give consent for participation in research. * gonorrhea and chlamydia screen negative within 60 days of entry to study. * willing to comply with the study requirements. * accessible by telephone. exclusion criteria: * had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days. * allergy to copper, or wilson's disease (for paragard; may have mirena) * intracavitary of symptomatic uterine fibroids. * ovarian, cervical or endometrial cancer. * severe anemia (defined as hgb \< 8).

Keywords: intrauterine device induced abortion medical abortion