Kornimate/medical-research-clean huggingface dataset:
acupuncture study on rheumatoid arthritis, monitoring microbiome and blood

Conditions: Rheumatoid Arthritis

Summary: acupuncture is used and recommended by the who for the treatment of rheumatoid arthritis. the molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional treatment with the ones treated with conventional treatment only. the investigators observe the variations in blood and in the gut microbiome.


Eligibility criteria:
inclusion criteria: * the patient should be diagnosed as the first or second stage of rheumatoid arthritis (ra) and checked with x ray for additional diagnose. * diagnosed for ra according to acr(1987) * the patient should be in the active stage of the disease, defined as： 1. swollen joints \>3 2. tender joints \> 5 3. any one of the following： (c1.) morning stiffness lasting more than 45 minutes (c2.) erythrocyte sedimentation rate (esr) \>= 28mm/h (c3.) c-reactive protein (crp)\>= 12mg/l * should not be resistant to mtx nor leflunomide * blood test should satisfy: 1. hemoglobin (hb)\>=85g/l 2. white cell \>=3.5 10+9/l 3. platelets \>= 100 10+9/l 4. liver function: serum alanine aminotransaminase (alt), aspartate transaminase (ast) and total bilirubin (tbil) should be less than 1.5 times the upper limit of normal (uln) 5. kidney function: serum creatinine (cr) level should be less than uln. 6. pregnancy test should be negative * should be positive for anti-cyclic citrullinated protein antibodies (anti-ccp). * should agree to sign the informed consent exclusion criteria: * serious diseases affecting liver, kidney, heart and lung, or diseases related to hematologic，endocrine and nervous systems. . * be treated by mtx or leflunomide in the last 3 months. * be treated with cortical hormone （could be intramuscular injection, intravenous injection or injection to articular cavity） in the last 4 weeks. * be treated with biological agents, such as antagonist of tnf-alpha,il-6, and cd20 mono antibody in the last 3 months. * be treated by chronic medicine, such as immunosuppressive agent, penicillamine, chloroquine and gold based disease-modifying antirheumatic drugs (dmards) in the last 3 months. * pregnant and breast-feeding woman * having history of serious drug allergy * in the acute or chronic phase of infection (such as lung diseases) * easy bleeding patients or patients with local skin infection (only for acupuncture) * the patients cannot accept acupuncture (only for acupuncture) * be treated with acupuncture in the past 3 months（only for acupuncture）. * no pregnant and breast-feeding woman. * no history of serious drug allergy.

Keywords: rheumatoid arthritis blood gut intestinal microbiome
clinical evaluation of the xpert® hiv-1 vl

Conditions: Human Immunodeficiency Virus

Summary: compare the clinical performance of the xpert® hiv-1 vl to another fda approved hiv-1 rna quantitative assay using frozen and fresh specimens from known hiv-1 positive individuals.


Eligibility criteria:
inclusion criteria: * hiv-1 seropositive adults using an fda approved method * at least 18 years of age or older * informed consent, if applicable exclusion criteria: * subject is less than 18 years of age * previously enrolled in this study * samples not collected according to the procedure

Keywords: hiv-1
experience from the italian s-icd registry

Conditions: Sudden Cardiac Death; Cardiac Arrest; Ventricular Arrythmia; Implantable Cardiac Defibrillator

Summary: the purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of subcutaneous implantable cardioverter defibrillator (s-icd) therapies in order to better understand how to improve the clinical care of patients and effectiveness of s-icd therapies.

isir is an observational, multicentric registry designed to collect implant and follow-up data of consecutive patients implanted with subcutaneous implantable cardioverter defibrillator (s-icd). a number of about 10 enrolling centers is estimated with an overall number of 400 patients. a minimal follow-up of 6 months is required before analyzing clinical outcomes. the data analysis will focus on implant outcomes and early, mid and long-term effectiveness of s-icd therapies and safety.

Eligibility criteria:
inclusion criteria: * age \>/= 18 years * patients successfully implanted with s-icd * patients able to provide written informed consent or have informed consent as provided by a legal representative
safety and efficacy of pletal (cilostazol) for the treatment of juvenile primary and secondary raynaud's phenomenon

Conditions: Raynaud's Disease

Summary: juvenile secondary raynaud's (ray-knows) phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. children with secondary raynaud's phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed connective tissue disease. when children with secondary raynaud's are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. the investigational drug, pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. it has been used in a variety of other conditions in which blood flow is decreased. this study will test the safety and effectiveness pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of secondary raynaud's episodes in juvenile patients.


Eligibility criteria:
inclusion criteria * 5 to 16 years old * fulfill diagnostic criteria for primary or secondary raynaud's

Keywords: secondary raynaud's circulatory vascular scleroderma lupus mixed connective tissue disease
single lipiflow treatment to reduce pharmacologic burden in ded

Conditions: MGD-Meibomian Gland Dysfunction

Summary: purpose: to evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.

prospective, non-randomized, interventional study. subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. all subjects underwent a vectored thermal pulsation treatment (lipiflow). patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment. data collected included tear osmolarity, tear break up time (tbut), tear meniscus height (tmh), meibomian gland function and patient-reported symptoms using the ocular surface disease index (osdi) questionnaire. following the 3-month visit, patients were given the option to resume topical immunomodulator therapy.

Eligibility criteria:
inclusion criteria: * no prior history of meibomian gland treatment procedures lipiflow, tearcare, or i-lux * lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years * meibograpy documneted retention of at least 50% of meibomian glands. exclusion criteria: * evidence of meibomian gland dropout exceeding 50% * ocular rosacea, * ocular surgery within the preceding three months * prior in-office thermal meibomian gland treatment * ocular trauma within preceding three months * ocular herpetic infection * chronic or recurrent inflammation * eyelid abnormalities affecting lid function ocular surface abnormalities compromising corneal integrity (eg, epithelial basement membrane dystrophy, corneal burn) * pregnant
the novel addiction assessment study in synthetic drugs addiction

Conditions: Amphetamine Addiction

Summary: the purpose of this research is to develop an objective assessment based on the virtual reality techniques which is used for evaluate addiction severity.

in order to evaluate the addiction severity and the effect of rehabilitation objectively, this study develops a virtual environment model based on the virtual reality technique, making the subjects in a drug related or neutral scene , at the same time recording the physical signs and eye movements index. reliability and validity of this system will also be tested in this study. and we will construct the norm of addiction assessment system in shanghai .the evaluating system will be very beneficial to develop novel and practical assessment for synthetic durg related disorder, and provide a reference for other drug dependence diagnosis.

Eligibility criteria:
criteria for synthetic drug abusers: inclusion criteria: * in accordance with the diagnostic and statistical manual of mental disorders-5 (dsm-4) for methamphetamine (ma) use disorders; * education level equal or more than 9 years; * have normal or corrected-to-normal vision; * have normal or corrected-to-normal hearing; * less than 3 months before last drug use; exclusion criteria: * current substance use (except nicotine or caffeine) ; * history of disease which influence cognition，such as seizure disorder、cerebrovascular disease、 head injury or other severe medication conditions; * intelligence quotient less than 70. criteria for healthy control: inclusion criteria: * without schizophrenia family history; * without history of drug abuse; * education level equal or more than 9 years; * have normal or corrected-to-normal vision; * have normal or corrected-to-normal hearing. exclusion criteria: * history of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions; * intelligence quotient less than 70.

Keywords: synthetic drugs virtual reality addiction evaluation physiological data eye movement index
a phase 3 study in patients with chronic kidney disease and hyperphosphatemia on peritoneal dialysis

Conditions: Chronic Kidney Disease; Renal Dialysis; Renal Insufficiency

Summary: this is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of asp1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.


Eligibility criteria:
inclusion criteria: * chronic kidney disease patients on peritoneal dialysis * hyperphosphatemia * patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not changed within 28 days. * written informed consent exclusion criteria: * patients with gastrointestinal surgery or enterectomy * patients with severe cardiac diseases * patients with severe constipation or diarrhea * patients with a history or complication of malignant tumors * patients with uncontrolled hypertension * patients treated with parathyroid intervention

Keywords: hyperphosphatemia peritoneal dialysis ckd asp1585
rescue immunotolerance study in induction of immune tolerance (iti)-experienced patients (res.i.s.t. experienced)

Conditions: Severe Hemophilia A

Summary: the purpose of this study is to evaluate whether a concentrate containing both fviii and von willebrand factor (vwf) given at a high dose will induce immune tolerance in subjects who have already experienced and failed iti with vwf-free fviii concentrates. the treatment on this study is expected to last up to 33 months.

the presence of factor viii (fviii) inhibitor prevents fviii infusions from working properly and makes treatment of bleeding episodes very difficult. having an inhibitor is a serious and life-threatening complication in patients with hemophilia. the usual treatment of patients with fviii inhibitors involves what is called "immune tolerance induction" (iti). immune tolerance means that the body can accept infused fviii and that fviii is again effective in controlling bleeds. iti involves giving high doses of fviii regularly until the inhibitor disappears. this treatment is not always effective. the inhibitor persists in about 1 in 5 patients who undergo iti. there are 2 types of fviii concentrates: fviii concentrates derived from human plasma, which contain vwf, and concentrates of fviii without vwf. both types of concentrates are commonly used to induce immune tolerance in patients with hemophilia a. retrospective studies on subjects who were treated with vwf containing factor viii concentrates after failing iti with pure factor viii concentrates, have shown that tolerance can be achieved in a large percentage of patients. this study will access prospectively whether treatment with a fviii concentrate containing vwf given at a high dose (200 units per kilogram) daily for up to 33 months is able to induce immune tolerance after previous attempts with concentrates containing only fviii have failed.

Eligibility criteria:
inclusion criteria: 1. severe hemophilia a (fviii\ 5 bu) 2. male, any age; 3. any inhibitor level at study enrollment; 4. ability and willingness to participate to the study; 5. previous iti course of at least 9 months with a vwf-free fviii concentrate at any dosage, such as recombinant fviii and/or monoclonally purified fviii. exclusion criteria: 1. concomitant systemic treatment with immunosuppressive drugs; 2. concomitant experimental treatment; 3. previous history of myocardial infarction and/or cerebral stroke

Keywords: iti haemophilia a inhibitors failed iti vwf/fviii concentrates
a qualitative study on the pain and quality of life of patients with fabry disease

Conditions: Fabry Disease

Summary: background it is necessary to find out the difficulties experienced by patients with fabry disease and their families, and to seek solutions for them. for this purpose, qualitative research with a patient-centered approach is useful. objectives the objective of this study is to understand the various difficulties of patients with fabry disease and to help them establish a comprehensive support system, medical, health, and welfare service system, and develop the direction and components of social and educational programs. methods the subjects of this study are patients who have been diagnosed with fabry disease, and among them, are selected considering the selection and exclusion criteria, confirm consent for participation in the study after sufficient explanation, and then enroll. the target number of subjects is 10 people. subjects who consented to the study had an in-depth interview centered on the in-depth interview questionnaire through the ha research institute, a specialized institution. * the principle of saturation is observed by conducting 3 interviews per research subject. * the duration of each interview per research subject is 50 to 60 minutes. * all dictations of the research subjects were recorded with prior consent and then transcribed into a written copy. * for 3 interviews, the number of interviews can be reduced to 1 or 2 by extending the interview time according to the research subject's request. * as for the place of interview, the research counseling room at severance cardiovascular hospital or the in-depth interview room in the ha research institute can be used, and the interview can be conducted at other places desired by the research subject at the request of the research subject.


Eligibility criteria:
inclusion criteria: 1. subjects who have delayed diagnosis of fabry disease or have experienced treatment refusal. 2. subjects who have been diagnosed with fabry name for more than 3 years or who have been treated for more than 1 year 3. adults between the ages of 19 and 70 who have the ability to consent to participate in the research (excluding those subject to adult guardianship) and have the cognitive ability to dictate their experiences 4. subjects who have experienced disadvantages and support in health-related quality of life, academic, job, family, social, and heterosexual relationships due to fabry disease 5. subjects who voluntarily gave written consent after hearing the explanation of the purpose and method of this clinical study exclusion criteria: 1. subjects who, in the opinion of the researcher, are unlikely to complete the study
outcomes of triaged family care in advanced cancer

Conditions: Advanced Cancer

Summary: the purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.

the purpose of this study is to: 1. determine if family dyads randomly assigned to either a brief or extensive family-based program of care have better proximal and distal outcomes from both a clinical and economic perspective than dyads randomly assigned to usual care 2. determine if the brief or extensive program of care has a differential effect on patient and caregiver outcomes depending on the patient's baseline risk for distress status (high versus low). a longitudinal, randomized clinical trial is being used for patients with advanced lung, colorectal, prostate, and breast cancer and their caregivers.

Eligibility criteria:
inclusion criteria: * patients with stage 3 or 4 breast, prostate, colorectal and lung cancers. * patients must be 21 years old or older, physically and mentally able to participate, speak and understand english, have a minimum life expectancy of six months, live within 75 miles of one of the participating sites and have a family caregiver who is willing to participate in the study. * for this study "family caregiver" is defined as the person who provides the patient with physical and/or emotional support during cancer treatment. * family caregivers must be 18 years old or older, physically and mentally able to participate, and speak and understand english. exclusion criteria: * patients will be excluded if they have multiple primary cancer sites. * family caregivers will be excluded if they, themselves, have been diagnosed with cancer during the previous year and/or are in active treatment for cancer.

Keywords: quality of life randomized clinical trial advanced cancer breast cancer colorectal cancer lung cancer prostate cancer family caregiver cancer survivorship coping communication uncertainty support depression self-efficacy benefits of illness caregivers
a study of topical danazol for the treatment of pain associated with fibrocystic breast disease

Conditions: Fibrocystic Disease of Breast

Summary: the purpose of this study is to determine the safety of three doses of topically applied danazol compared to placebo in subjects with pain associated with fibrocystic breast disease and to determine the appropriate clinical dose for future studies.


Eligibility criteria:
inclusion criteria: * menstruating females at least 18 years of age * has moderate to severe breast pain associated with cyclical fibrocystic breast disease * is in good general health exclusion criteria: * pregnant within the past 6 months or lactating * history of malignancy or currently being treated for cancer of the breast or genital organs * has taken within the past 3 months or is currently taking hormonal contraception * has any condition for which an androgen or steroid is contraindicated * has had breast implants or breast reduction surgery

Keywords: fibrocystic breast disease fibrocystic disease of breast breast pain mastalgia cyclic mastalgia cystic breast disease
optimal postoperative chest tube and pain management in patients surgically treated for primary spontaneous pneumothorax (pneumotrial)

Conditions: Pneumothorax, Primary Spontaneous; VATS; Pain, Postoperative; Locoregional Anaesthesia; Thoracic Epidural; Chest Tube Drainage

Summary: guidelines lack high quality evidence on optimal postoperative chest tube and pain management after surgery for primary spontaneous pneumothorax (psp). this results in great variability in postoperative care and length of hospital stay (los). chest tube and pain management are prominent factors regarding enhanced recovery after thoracic surgery, and in standardised care they are crucial to improve quality of recovery and decrease los. historically, postoperative chest tubes are left in place for at least a fixed number of 3-5 days, irrespective of absence of air leakage. this period was deemed necessary for adequate pleurodesis and prevention of recurrence. however, it is suggested that removal on the same day of surgery is safe and associated with a reduced los. regarding postoperative pain management, thoracic epidural analgesia (tea) is the gold standard for postoperative pain management following video-assisted thoracic surgery (vats). although the analgesic effect of tea is clear, it is associated with hypotension and urinary retention. therefore, unilateral regional techniques, such as paravertebral blockade (pvb), are developed. the investigators hypothesize that early chest tube removal accompanied by a single-shot paravertebral blockade (pvb) for analgesia is safe regarding pneumothorax recurrence and non-inferior regarding pain, but superior regarding los when compared to standard conservative treatment.


Eligibility criteria:
inclusion criteria: * all patients operated for psp * age ≥ 16 years * able to read and understand the dutch language * mentally able to provide informed consent * patients should have a preoperative chest ct scan in order to exclude evident secondary pneumothorax. previously made ct scans, within a time range of maximum 5 years, are accepted. the identification of blebs or bullae on ct scan is not defined as secondary pneumothorax. exclusion criteria: * previous ipsilateral thoracic surgery (except diagnostic thoracoscopy only) or ipsilateral thoracic radiotherapy * underlying lung disease that provoked the pneumothorax (secondary pneumothorax): genetically proven birt-hogg-dubé syndrome, periodic pneumothorax in female patients in reproductive age with known endometriosis (or known catamenial pneumothorax), pulmonary cystic fibrosis, active pneumonia, lung fibrosis, chronic obstructive pulmonary disease (copd), pulmonary ipsilateral malignancy * contra-indications for tea (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, sepsis and mechanical spine obstruction) * patients chronically (\>3 months) using opioids will be excluded since postoperative baseline opioid requirement will be higher and tea remains the preferred technique for these patients * allergic reactions to analgesics used in the study
safety and effectiveness study of the solysafe septal occluder in patients with atrial septum defect and patent foramen ovale

Conditions: Atrial Septal Defect; Patent Foramen Ovale

Summary: this is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (asd) and patent foramen ovale (pfo).


Eligibility criteria:
inclusion criteria: * asd * pfo with a medical history of cryptogenic stroke due to presumed paradoxical embolism caused by a pfo exclusion criteria: * criteria that exclude catheterization (e.g. size too small, disseminated intravascular coagulopathy (dic), high risk of bleeding such as coagulation or clotting disorders)