Kornimate/medical-research-clean huggingface dataset:
a study of the safety and efficacy of fabrazyme in patients with fabry disease

Conditions: Fabry Disease

Summary: people with fabry disease have an alteration in their genetic material (dna) which causes a deficiency of the a-galactosidase a enzyme. fabrazyme is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." these glycolipids are normally present within the body in most cells. in fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase a is not present, or is present in small quantities. the build up of glycolipid ("globatriaosylceramide" or "gl-3") levels in these tissues in particular is thought to cause the clinical symptoms that are common to fabry disease. this study will test the safety and efficacy of fabrazyme in the treatment of patients with fabry disease.


Eligibility criteria:
inclusion criteria: * patients must have successfully completed the previous double-blind study (agal-1-002-98) * patients must provide written informed consent prior to study participation * female patients must have a negative pregnancy test prior to each dosing and use a medically accepted method of contraception throughout the study exclusion criteria: * patient has undergone kidney transplant or is currently on dialysis * patient is pregnant or lactating * patient is unwilling to comply with the requirements of the protocol * patient has a clinically significant organic disease (with the exception of symptoms related to fabry disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would preclude participation in the study

Keywords: a-galactosidase a agal r-hagal fabry gl-3 fabrazyme
muscle mass and function in chinese adults

Conditions: Sarcopenia

Summary: to describe the normal range of muscle mass and function in chinese adults.

the study objective is to setup a normal range of muscle mass and function in chinese adults.

Eligibility criteria:
inclusion criteria: 1. young adult ages between 25 and 34 years, inclusively. 2. adult is judged to be in good health as determined from his/her medical history as his/her self-report to the enrolling center personnel and as confirmed through a clinical examination by a physician. 3. adult with bmi between 18.5 to 26.9. 4. male or non-pregnant non-lactating female. non-pregnant should be confirmed by urine pregnant test. and non-lactating is defined as postpartum more than 18 months. 5. subject has voluntarily signed and dated an informed consent form, approved by an independent ethics committee/institutional review board (iec/irb) prior to any participation in the study. exclusion criteria: 1. subject who is heavy manual labor. 2. subject who is professional or semi-professional athlete or game player. 3. subject who is physical disabilities, such as loss of hand or foot or limbs or any physical disability which may affect the physical activities and affect the distribution of muscle mass by the opinion of the study physician. 4. subject has known chronic diseases such as endocrine system diseases (including type 1 or type 2 diabetes mellitus, or hyperthyroidism or hypothyroidism), cardiovascular diseases, liver diseases, and renal diseases as self-report. 5. subject who has active infection of tb, hiv and hepatitis as self-report. 6. subject who currently experiencing diarrhea or anorexia within 7days prior to the enrollment. 7. subject who has or plans for intensive physical activities 3 days prior to the scheduled bia measurement. 8. subject who is thyroid malfunction (as serum ft4 level and/or serum tsh level out of the reference range of the lab) 9. subject has implanted electronic device, orthopedic metal implantations, such as pacemaker, cardiac defibrillator, or metal hip, metal knee joint, metal fracture internal fixation, etc. 10. subject is drug addiction or alcohol addiction. 11. subject is anemia (as blood hemoglobin level less than 120 g/l in males and 110 g/l in females). 12. subject is malnourished by study physician's opinion 13. subject has active cancers as self-report 14. subject has lost or gained more than 5% of body weight in the past 3 months 15. subject attends other clinical trials and is not approved by an
assessing cognitive decline at home

Conditions: Mild Cognitive Impairment; Mild Dementia; Dementia Alzheimers; Dementia; Memory Impairment; NPS

Summary: neuropsychiatric symptoms (nps) refer to a range of mental and emotional issues that can be observed through how patients move, perform daily tasks, and express feelings on their faces. in this study, the investigators want to find ways to accurately and unobtrusively track these symptoms in people's homes over time. our goals are to note when these symptoms happen, predict potential problems, and gather clear data to help doctors make accurate diagnoses. to do this, the investigators will first collect information from participants who have in-home sensors. the investigators will then use special computer programs that can recognize everyday activities and identify features that connect to scores from the mild behavioral impairment checklist (mbi-c). these scores will be compared to a questionnaire (npiq) filled out by caregivers or family members, along with any relevant information from doctors about the patients' symptoms. the investigators aim to see how these features can help differentiate between types of nps, such as mood changes and agitation. finally, the investigators will create a dashboard for doctors that summarizes the patterns of these symptoms in patients, making it easier to monitor and manage their mental health.

what the investigators would need from participants: * collect the participants' own data of daily activities from a room in participants home such as the participant's living room via a small camera the investigators provide for no less than 7 days and up to 30 days. the participant will have full control over the camera to turn on and off. * the participant and a loved one will regularly answer short surveys asking about the participant's mood and daily functioning. * at the end of agreed observation period, return the memory card of the participant's collected data from the camera in person or pre-paid fedex envelope.

Eligibility criteria:
inclusion criteria: * age 65+ years old * any age and ethnicity. * with or without, or at risk of mild to moderate dementia and healthy controls. * availability of a study partner (informant) who has contact with the patient at least once a week (this can also be the surrogate/lar but does not necessarily have to be) exclusion criteria: * those with severe mobility impairments * participants in non-home settings (skilled nursing facilities, etc.).
propofol versus midazolam with fentanyl for egd endomicroscopy

Conditions: Gastritis; Functional Dyspepsia

Summary: this trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.


Eligibility criteria:
inclusion criteria: * outpatients attending endomicroscopy * able to give written informed consent exclusion criteria: * gi tract malignancy * coagulopathy * acute upper digestive tract bleeding * pregnancy or breast feeding * allergy to fluorescein sodium * impaired renal function

Keywords: normal
effects of combined aerobic and resistance training in patients with intermittent claudication

Conditions: Peripheral Arterial Disease; Endothelial Dysfunction

Summary: exercise training improves walking capacity and regional perfusion in patients with intermittent claudication (ic). endothelial progenitor cells (epcs) and endothelial microparticles (emps) could play an important role in this process, promoting the healing of the diseased endothelium. the investigators are going to measure epcs and emps in a group of patients with ic and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. subsequently, a group of ic patients will be randomly assigned to perform a 12-week home-based exercise training program. the investigators expect a significant increase of emps and epcs after acute and chronic physical activity. we expect also a correlation between the increase of emps and epcs and the improvement in walking capacity. aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of emps and epcs in patients with ic and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with ic.


Eligibility criteria:
inclusion criteria: * history of stable intermittent claudication (pad, stage ii fontaine) * resting ankle-brachial index (abi) \<0,9 and the presence of occlusion or significant stenosis at the color-doppler duplex ultrasound scanning exclusion criteria: * lower-limb ischemic rest pain or gangrene (fontaine stages iii and iv) * inability to obtain the abi value or to perform a walking test * exercise tolerance limited by factors other than claudication (i.e., arrhythmias, cardiac symptoms or exaggerated blood pressure rise, severe obesity) * end-stage liver or renal failure * acute or chronic inflammatory conditions * history of recent (\<6 months) acute coronary syndrome, cerebrovascular event or inducible myocardial ischemia * treatment with drugs known to affect walking capacity, including calcium-channel blockers, β-blockers and angiotensin-converting enzyme inhibitors.
effect of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer

Conditions: Prostate Cancer

Summary: the objective of this study is to assess the effect of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer


Eligibility criteria:
inclusion criteria * prostate cancer * radical prostatectomy or external beam irradiation therapy within 6 months before study entry. * no bone metastases according to bone scan exclusion criteria * metastatic prostate cancer * hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy * treatment with bisphosphonates or other drugs known to affect the skeleton within the past year. other protocol-defined inclusion / exclusion criteria may apply.

Keywords: prostate cancer molecular staging antitumor potential
comparing rates of glaucoma in professional wind versus non-wind instrument players

Conditions: Glaucoma; Intraocular Pressure; Optic Neuropathy

Summary: the purpose of the present study is to compare rates of glaucomatous optic neuropathy in professional wind versus non-wind instrument players in the philadelphia orchestra. a secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind instrument players under variable playing conditions.

participants of this study will be any current or retired member of the philadelphia orchestra. approximately 100 participants will be divided into 2 groups: 1) wind instrument players and 2) non-wind instrument players. a wind instrument is defined as any instrument that contains a resonator, in which a column of air is set into resonation by the player blowing into a mouthpiece at one end of the resonator. a non-wind instrument is defined as any instrument that does not meet the wind instrument criteria. on the day of the eye examinations, the investigator will provide a brief overview to explain the purpose and goals of the study to all potential participants. the examination team will be set up in an adjoining room. members of the orchestra will be able to visit the examination team at any time during their practice session. a trained technician will perform the following for both eyes for all participants:visual acuity,undilated fundus color photography and intra-ocular pressure measurement. the investigators will record the examination findings using a standard form. demographic information, including ocular, medical, social, and family history, will be documented for all participants.

Eligibility criteria:
inclusion criteria: * play wind or non-wind instrument for average of 1 hour per day for minimum of 5 years. * normal general health. exclusion criteria: * incisional eye surgery \<1 month prior to visit 1.
an extension long-term safety and tolerability trial of degarelix in chinese patients with prostate cancer

Conditions: Prostate Cancer

Summary: this trial is an open-label, multi-centre, single arm extension for the 000006 trial in chinese patients with prostate cancer. eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/ml) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit in this extension trial. patients, who received goserelin treatment in the main trial, will get a degarelix starting dose (240 mg; 40 mg/ml) at the first visit and continue on degarelix treatment. the purpose of this 2-year extension trial is to collect long-term safety and tolerability data for the one-month dosing regimen.


Eligibility criteria:
inclusion criteria: * has given written informed consent before any trial-related activity is performed. a trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient * has completed the 000006 trial exclusion criteria: * has been withdrawn/discontinued from the 000006 trial.
routine nasobiliary insertion during ercp in high risk patients.

Conditions: Gallstones Complicated by CBD Stones

Summary: 110 patients with common bile duct (cbd) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy admitted to departement of surgery of minia university hospital for ercp then laparoscopic cholecystectomy (lc). the patient divided into 2 equal group. in group 1, nasobiliary (nb) catheter was inserted during ercp after cbd clearance. in group 2, only cbd clearance was done. in all patients lc was done within the same week of ercp. tans-nasobiliary intraoperative cholangiography was done and methylene blue injected at the end of the procedure to detected any leak in nb group

110 patients with common bile duct (cbd) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy as , age \> 65 , male sex, obesity, acute cholecystitis, previous upper abdominal surgery, and certain ultrasonographic findings i.e. distended gall bladder (gb), thickened gb wall, pericholecystic fluid collection and impacted stone etc. these patients admitted to department of surgery of minia university hospital for ercp followed with laparoscopic cholecystectomy (lc). the patient divided into 2 equal group. in group 1, nasobiliary (nb) catheter was inserted during ercp to settle high up in the intrahepatic biliary tree after complete cbd clearance. in group 2, only cbd clearance was done. in all patients lc was done within the same week of ercp. sequential, multiple, step after step, tans-nasobiliary intraoperative cholangiography was done during every step in cholecystectomy especially during dissection of calot's triangle and just before clipping of supposed cystic duct (cd) to make sure that the structure supposed to be cd was not the cbd. after the end of procedure methylene blue is injected from the the nb to detected any leak and if present

Eligibility criteria:
inclusion criteria: * patients with gb stone complicated with cbd stones * accept to share in the study * the presence of one or more preoperative predictors for high risk for difficult cholecystectomy * patient fit for lc exclusion criteria: * patients\ 80 * unfit for surgery * didn't accept to share in the study
safety and efficacy of grt6005 in pain due to diabetic polyneuropathy

Conditions: Pain; Diabetic Neuropathies

Summary: the purpose of this trial is to investigate the efficacy and safety of grt6005 in patients with painful diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * men and women, 18 to 75 years old. * type 1 or type 2 diabetes. * painful dpn symptoms and signs for at least 3 months. * blood glucose controlled with medication. * glycosylated hemoglobin not greater than 9.5 or 11%, country dependent. * prior analgesic medication. * average score of 4 or greater on the 11 point nrs during the last 3 days prior to randomization. exclusion criteria: * impaired liver, cardiac or renal function. * breastfeeding and pregnancy. * history of substance abuse, alcohol or medication. * chronic gastrointestinal disease. * history of seizures and or epilepsy. * history or presence of malignancy. * presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis. * allergies to opioids, acetaminophen or excipients of the medications.

Keywords: analgesia analgesics pain chronic pain neuropathic pain
a study to evaluate the efficacy and safety of micafungin against invasive candidiasis or candidemia

Conditions: Candidemia; Candidiasis

Summary: to evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by candida sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in china.


Eligibility criteria:
inclusion criteria: * the diagnosis criteria of probable candida infection: risk factors + clinical manifestations + positive findings including microbiologic test * the diagnosis criteria of proven candida infection: risk factors + clinical manifestation + positive findings including microbiologic test + tissue culture or pathological examination results * the following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia: 1. risk factor (s) of infection 2. clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections 3. two or more positive sputum culture for candida exclusion criteria: * patient received any other antifungal drug within 1 month prior to enrollment. * hiv positive patient * patients with organ transplant * patients with agranulocytosis

Keywords: micafungin candidiasis candidemia open-label design
early sleep apnea termination using sound stimulation

Conditions: Sleep Apnea

Summary: current evidence suggest that sleep apnea-associated oxygen desaturations may induce cardiovascular morbidities in the long term, whereas arousals associated with sleep apneas seem to induce mainly transient nocturnal hypertension. reducing the occurrence and the magnitude of sleep apnea-associated oxygen desaturations could therefore have a beneficial effect on sleep apnea-associated comobidities. since sleep apneas usually end with an arousal allowing pharyngeal muscles reactivation, a treatment option could consist of generating an early short awakening to anticipate apnea termination and decrease the risk of oxygen desaturation. the aim of this study is thus to determine if an early sleep apnea termination through the emission of a sound can achieve lower oxygen desaturations compared with "untreated" sleep apneas.

the aim of the study is to determine the effect of short sound stimulations on sleep apnea associated desaturations 20 osa subjects will be recruited and studied with polysomnography and a head band allowing to emit short sound stimulations during sleep. the study will take nplace at the center for investigation and research in sleep (cirs) the magnitude of oxygen desaturations following apnea with and without sound stimulations will be compared. the effects of different types of sound stimulations on the magnitude of cortical and autonomic reactions will also be studied as well as the patients' subjective perception of the sounds.

Eligibility criteria:
inclusion criteria: * age \> 18 years * able to give informed consent as documented by signature * apnea / hypopnea index \> 30 / h (severe) * obstructive apnea index \> 15 / h * mean amplitude of desaturations (during diagnostic night) ≥ 5% exclusion criteria: * perception deafness * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc., * professional drivers
dna methylation in brugada syndrome and risk of sudden cardiac death

Conditions: Brugada Syndrome; Sudden Cardiac Death Due to Cardiac Arrhythmia

Summary: the goal of this observational study is to evaluate if there are differences in dna methylation of peripheral blood in patients with brugada syndrome and healthy subjects. the main question it aims to answer is: does dna methylation changes distinguish brugada patients from healthy controls? does dna methylation changes distinguish brugada patients with high versus low risk of sudden cardiac death?

the investigators will enroll 10 patients with brugada syndrome and 10 age and sex matched healthy controls. we will collect 5 ml of peripheral blood and will analyze genome-wide dna methylation via epic array platform. bioinformatic algorithms and network analysis will be applied to identify possible diagnostic and predictive biomarkers.

Eligibility criteria:
inclusion criteria: * brugada syndrome was confirmed when the 12-lead ecg showed st-segment elevation with a type-1 morphology of ≥2 mm in ≥1 right precordial lead either spontaneously or after a provocative drug test (intravenous administration of a class i antiarrhythmic) in the absence of any structural heart disease. * \>18 years * unrelated patients exclusion criteria: * related patients * not type 1 br patter

Keywords: dna methylation liquid biopsy sudden cardiac death brugada syndrome