Kornimate/medical-research-clean huggingface dataset:
performance evaluation of contact lenses among a population of adapted contact lens wearers

Conditions: Vision Disorders

Summary: this study is being conducted to evaluate bausch \& lomb purevision multi-focal contact lenses compared to the bausch \& lomb soflens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.


Eligibility criteria:
inclusion criteria: * subjects must have clear central corneas and be free of any anterior segment disorders. * subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks. * subjects must wear a lens in each eye and each lens must be of the same manufacture and brand. exclusion criteria: * subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation. * subjects with any systemic disease affecting ocular health * subjects with an active ocular disease or using any ocular medication. * subjects who have had any corneal surgery (eg, refractive surgery).
safety and feasibility study of mesenchymal trophic factor (mtf) for treatment of osteoarthritis

Conditions: Osteoarthritis of the Knee

Summary: allogeneic mesenchymal trophic factors (mtf) from human umbilical cord tissue-derived mesenchymal stem cells (uc-msc) injected into the knee joints of 20 patients (group 1) or injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for inducing joint function improvements in osteoarthritis (oa) patients with grade 2, 3, or 4 radiographic oa severity.

the proposed study will assess primary safety and secondary efficacy endpoints of allogeneic uc-msc-derived mtf administered to two arms osteoarthritis patients with grade 2, 3, or 4 radiographic oa severity (20 per arm). the first arm will receive an intra-articular injection of mtf into the knee joint under fluoroscopy. the second arm will receive 12 subcutaneous mtf injections, once per week. for both arms, the primary objective of safety will be defined as freedom from treatment associated adverse events for the period of one year. the secondary objective of efficacy will include evaluation at baseline and at months 3 and 12 of efficacy endpoints of joint function improvement as assessed by western ontario and mcmaster universities osteoarthritis index (womac).

Eligibility criteria:
inclusion criteria: * age \>18 years and ability to understand the planned treatment. * subjects 18 years of age or older with idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified kellgren-lawrence classification exclusion criteria: * pregnant women or cognitively impaired adults. * presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging. * inflammatory or post infectious arthritis. * more than 5 degrees of varus or valgus deformity. * kellgren lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age. * intra-articular corticosteroid injection within the previous 3 months. * a major neurologic deficit. * serious medical illness with a life expectancy of less than 1 year. * prior admission for substance abuse * body mass index (bmi) of 40 kg/m2 or greater * patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent * in the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy

Keywords: osteoarthritis umbilical cord mesenchymal stem cells trophic factors
response of arteriovenous fistula puncture-related pain to cryotherapy application in haemodialysis patients

Conditions: Hemodialysis Complication

Summary: kidney disease occurs when kidney reduces its normal function, less than 30% of normal activity is related to a long-term condition. therefore, people need to participate in a haemodialysis (hd) programme. in hd, blood is filtered by an external machine, done about three times a week and the access is gained through intermittent vascular cannulation. the patients experience considerable pain due to the frequent insertion of avf catheters. hemodialysis patients experience anxiety before needle insertion due to repeated punctures, and over 90% of patients experience acute pain during the process. puncture-related pain during arteriovenous fistula (avf) cannulation in particular is a crucial influential factor in quality of life. cryotherapy is one of the interventions used in several studies to alleviate the arteriovenous fistula puncture-related pain. it can be conduct by using ice packs and the results of the previous studies have also shown its positive effects on the relief of the fistula puncture-related pain in these patients.

ninety male and female patients with end stage renal disease randomly assigned into three equal groups (n=30) their ages ranged between 30-50: 1. group a (30 patients) receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. 2. group b (30 patients) receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. 3. group c (30 patients) it is a control group this group not received ice pack.

Eligibility criteria:
inclusion criteria: * the study includes patients with ages from 30 to 50 years. * patients able to report pain adequately. * patients with end-stage kidney failure undergoing regular hemodialysis who have been treated for more than 3 months, at least twice per week, with arteriovenous fistula in use for more than 1 month are included in the study. exclusion criteria: patients with conditions such as * advanced age, * advanced diabetes, * cardiovascular insufficiency, * cold allergy, * reynaud's phenomenon, * nerve and tissue damage, * fractures, * heart failure, * uncooperative patients, * cognitive impairment preventing a proper assessment of pain.
effect of platelet-rich plasma (prp) injection on knee osteoarthritis

Conditions: Platelets-rich Plasma; Osteoarthritis Knees Both; Meniscus Disorder; Cartilage Injury

Summary: to evaluate the safety and effectiveness of prp injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury.


Eligibility criteria:
inclusion criteria: * the age range of the participants was 20 to 60 years old. through a comprehensive clinical and imaging examination, it was conclusively determined that the individuals had knee osteoarthritis or experienced injuries to the cart, and meniscus surrounding the knee joint. * the preoperative routine tests and examinations revealed no contraindications. * revised sentence: "informed consent of the patient exclusion criteria: * the platelet count or function exhibits significant abnormalities、systemic infection transmitted through the bloodstream. * prolonged usage of anti-inflammatory drugs and systemic corticoid administration. * in injection site or damage to the skin. * patients with tumors or undergoing radiotherapy and chemotherapy. * pregnant or breastfeeding women. * individuals with mental illnesses who are unable to cooperate with follow-up procedures. * contraindications for mri、patients or their families do consent to participate in the study. * other circumstances that render participation in the study unsuitable.

Keywords: platelets-rich plasma osteoarthritis cartilage injury meniscus injury
efficacy and safety of probiotic treatment as a supportive therapy in eradication of h. pylori

Conditions: Helicobacter Pylori Infection

Summary: the aim of the study is to establish efficacy and safety of normia® probiotic, used as an add-on therapy in treatment of h. pylori infection with the standard triple therapy approach. the primary objective in the study is determination of efficacy of normia® probiotic as a supportive therapy in achieving a higher percentage of eradication of h. pylori. the secondary objectives are to assess: * safety profile of normia® probiotic in everyday use, e.g. reduction in number of side-effects and better compliance to the eradication therapy * safety and efficacy of normia® probiotic in different demographic subgroups

gastroenterologists and general practitioners have increasingly more possibilities of prescribing probiotic preparations as the only or (more often) adjuvant therapy in certain indications. a significant step forward was made in the current report of the european helicobacter study group ,which states that "certain probiotics and prebiotics show promising results as an adjuvant treatment in reducing side effects". at this stage,probiotics are classified as grade d recommendation. that is precisely why the investigators believe that clinical studies are necessary in order for such effects to be objectively proven in a clinical setting. the investigators decided to conduct a clinical trial based on a clearly defined and sufficiently frequent indication,with a preparation of known probiotic composition that is easily available on the market, and in a real setting where such approach is bound to show both advantages and disadvantages.

Eligibility criteria:
inclusion criteria: * confirmed h. pylori infection. * otherwise healthy subjects taking h. pylori eradication therapy. * age above 16 years. * male and female subjects. * subject who provided written informed consent prior to undergoing any study procedure. exclusion criteria: * pregnancy or lactation. * severe diseases such as malignant diseases, severe renal/liver impairment, hiv infection etc. * chronic diseases such as diabetes mellitus, hypertension, epilepsy or atherosclerosis which are under treatment and well regulated are not an exclusion criterion. * subject who is not mentally capable of adhering to the protocol. * drug addiction or alcoholism. * any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications. * subjects participating in any other clinical trial.

Keywords: gastritis helicobacter pylori
safety and effectiveness of transdermal buprenorphine in cancer pain

Conditions: Cancer

Summary: buprenorphine transdermal patch is newly available in taiwan in june 2017, the trade name is transtec, and the available dosages are 35 μg/h and 52.5 μg/h. taiwan is the first asia country which launched transtec for cancer pain treatment. although the efficacy of transdermal buprenorphine has been demonstrated in some randomized, placebo-controlled studies and also conducted a large scale post-marketing surveillance study in germany, therefore the local scientific data is required for asia experience. due to above rationale, this observational study will be initiated in taiwan, to build up the first real-world scientific data in asia. the objective of this study is to collect the safety and effectiveness of transdermal buprenorphine in routine clinical practice, in particular, to collect data in population with controlled cancer pain and stable titration from previous opioid analgesics in taiwan.

the objective of this observational study is to collect effectiveness and safety data on the labelled use of buprenorphine transdermal patches (transtec 35 μg/h and 52.5 μg/h) under regular and routine clinical conditions in taiwan for cancer patients with moderate to severe cancer pain (nrs score\>=4) and strong opioids are needed for their pain treatment.

Eligibility criteria:
inclusion criteria: 1. cancer patients aged 20 years old and over 2. ecog \<3 3. moderate or severe pain intensity with stable titration from previous opioid analgesics, 7 days at least prior to enrolment and with the dose equivalent to oral morphine ranging from 60 to 120 mg/day in previous treatment 4. cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic 5. patients who are going to start transtec treatment per clinical judgment, according to the locally approved labeling, are eligible. 6. patients who are able to communicate and fill out the questionnaire forms 7. patient provided signed informed consent exclusion criteria: 1. patients diagnosed with non-cancer pain or unexplained pain 2. patients who have constipation (ctcae grade 3 and above) 3. patients with uncontrolled or unstable cardiac disease 4. abnormal lab results, with obvious clinical significance, such as alt or ast\>= 3 fold of upper limit of normal value or liver function of child c grade prior to study 5. alt or ast \>= 5 fold of upper limit of normal value for patients with liver metastasis or primary liver cancer 6. pregnant or nursing (lactating) women 7. patients who are drug or alcohol abuse 8. patients who have hypersensitivity to buprenorphine 9. patients who are clinically unstable or have a life expectancy of less than 8 weeks making completion of the trial unlikely 10. with any contraindications or using prohibited medication per locally approved

Keywords: transdermal buprenorphine, cancer pain, qol, nrs, narcotics
paclitaxel, carboplatin, and oral etoposide followed by weekly paclitaxel in high grade neuroendocrine carcinoma

Conditions: Neuroendocrine Carcinoma

Summary: carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients with poorly differentiated neuroendocrine carcinomas. we hope to identify a "standard treatment" for this unusual group of patients who are not usually eligible for clinical trials.

upon determination of eligibility, patients will be receive: * paclitaxel + carboplatin + etoposide

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * metastatic poorly differentiated neuroendocrine carcinoma * unknown primary site * able to perform activities of daily living with minimal assistance * measurable or evaluable disease * adequate bone marrow, liver functions and kidney function * no previous treatment with chemotherapy * understand the nature of this study and give written informed consent. exclusion criteria: you cannot participate in this study if any of the following apply to you: * age \< 18 years * previous malignancy within five years * women pregnant or lactating * recent history of cardiovascular disease * meningeal metastases please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
effect of ketogenic diet on peri-operative complications of right laparoscopic adrenalectomy in obese patients

Conditions: Adrenalectomy; Status; Obesity, Morbid

Summary: ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. the study aim to investigate the possible effects of ketogenic diet on intra- and peri-operative complications of right laparoscopic adrenalectomy in obese patients; researchers will analyze intra- and peri-operative outcomes among obese patients who underwent laparoscopic right adrenalectomy, comparing the two arms with and without ketogenic diet.

ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. due to a standard trans abdominal laparoscopic right adrenalectomy is performed with the patient in left lateral position, it is necessary to retract liver in order to expose the right adrenal gland and the cava vein. it is therefore evident how a reduced size liver may allow a faster, easier and safer surgery. finding a normal size liver is uncommon in patients presenting with a body mass index above 30 kg/m2. according to this, patients scheduled to right laparoscopic adrenalectomy and belonging to the case arm, will be administered a standard 21 days ketogenic diet before surgery. conversely this will not be prescribed to patients belonging to control group. ketogenic diet is based on a standard diet plus a ketogenic product to be taken once daily for 21 days. in both groups patients will undergo abdominal ultrasound before surgery.

Eligibility criteria:
inclusion criteria: * bmi \> 30 kg/m2 * planned for laparoscopic right adrenalectomy * age \> 18y.o. * no contraindications for ketogenic diet exclusion criteria: * diabetes * patients requiring conversion to open surgery * bmi \< 30 kg/m2 * age \< 18 y.o.
expanded access protocol of viaskin® peanut (dbv712) in peanut-allergic children

Conditions: Peanut Allergy

Summary: this is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with dbv712 250 mcg.

this study is an open-label expanded access protocol to provide continued treatment with dbv712 for individuals completing a dbv clinical study. participation is by invitation according to the inclusion criteria. for individuals who have received dbv712 for longer than one year prior to entry into this protocol, where treatment allocation is unblinded, safety assessment and resupply of dbv712 will occur at 6-month intervals. there will be no other scheduled study visits. for individuals who have been on blinded treatment, a safety assessment will be conducted at months 1 and 3. visits for safety assessment and resupply of dbv712 will occur at 3-month intervals during the first 12 months. after a year, visits will occur at 6-month intervals. dbv712 will be supplied to participants at study visits to suffice until the next visit. for individuals who have been on blinded treatment, or off dbv712 treatment for more than 14 days prior to entry into this protocol, dosing consists of approximately 6 hours for the first week, 12 hours for the second week, then once daily, at approximately the same time of day. treatment with dbv712 will continue until, in the clinical judgement of the treating physician, the participant is no longer benefiting from continuation of the treatment, dbv712 is approved and available by prescription, or the study is terminated.

Eligibility criteria:
inclusion criteria: * participation is by invitation, limited to individuals completing clinical study v712-303 (people), previous expanded access program or a dbv clinical study initiated after 31-jan-2022 * male and females; ages ≥ 2 years old at visit 1 or current or prior studies. * negative urine pregnancy test for female participants of childbearing potential. exclusion criteria: * early withdrawal from a dbv712 clinical study. * history of non-compliance during the primary clinical study or unable to follow the protocol requirements. * generalized dermatologic disease extending widely on the skin. * history of intolerance or who developed hypersensitivity to excipients of the dbv712 patches.

Keywords: epit epicutaneous immunotherapy viaskin
phase ii study of anlotinib versus sunitinib in patients with advanced renal cell carcinoma（rcc）

Conditions: Anlotinib; RCC

Summary: anlotibib (al3818) is a kind of innovative medicines approved by state food and drug administration（sfda:2011l00661） which was researched by jiangsu chia-tai tianqing pharmaceutical co., ltd. anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for vegfr2、vegfr3、pdgfrβ and c-kit. it has the obvious resistance to new angiogenesis. the trial is to compare the efficacy and safety profile between anlotinib and sunitinib in patients with advanced renal cell carcinoma(rcc).


Eligibility criteria:
inclusion criteria: * 1.patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery * 2.without drug treatment for rcc or chemotherapy/cytokine therapy failure or resistant patients) * 3.with measurable disease (using recist1.1) * 4.18-75years,ecog ps:0-1,life expectancy of more than 3 months * 5.other cytotoxic drugs,radiation therapy,or surgery≥4 weeks * 6.main organs function is normal * 7.signed and dated informed consent exclusion criteria: * 1.previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, sorafenib) * 2.patients has many influence factors toward oral medications * 3.known brain metastases * 4.patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade i myocardial infarction, arrhythmias and class i heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (fbg)\>10mmol/l);urine protein≥++,etc. * 5.patients failed to heal wounds or fractures for long-term * 6.patients occurred venous thromboembolic events within 6 months * 7.patients has hiv-positive or organ transplantation

Keywords: anlotinib sunitinib renal cell carcinoma（rcc）
prospective study of the natural history of patients with type 2 and 3 spinal muscular atrophy

Conditions: Type 2 Spinal Muscular Atrophy; Type 3 Spinal Muscular Atrophy

Summary: nathis-sma is a prospective, longitudinal and interventional study of the natural history of patients with type 2 and 3 spinal muscular atrophy (sma). the purpose of this study is to characterize the disease course over 2 years and identify prognostic variables of the disease and biomarkers of sma progression, as well as determine the best outcome measures for further therapeutics approaches.


Eligibility criteria:
inclusion criteria * type 2 or 3 spinal muscular atrophy genetically confirmed * age superior or equal to 2 years old up to 30 years of age included * for patients older than 6 years old, willing and able to comply with all protocol requirements and procedures. * for non-ambulant patients, able to sit upright in a wheelchair for at least three hours * patients over 18 years of age and parent(s)/legal guardian(s) of patients \< 18 years of age must provide written informed consent prior to participating in the study and informed assent will be obtained from minors at least 7 years of age when required by regulation. * in france only: affiliated to or a beneficiary of a social security category exclusion criteria * previously treated with an investigational drug within 6 months prior the recruitment in this study. * other condition which may significantly interfere with the assessment of the sma and is clearly not related to the disease * current or anticipated participation in any therapeutic investigational clinical studies. * patients with specific contraindication to mri (i.e. metallic foreign body, claustrophobia, and others deemed to be prohibitive by the investigators) will be allowed to participate, but mri will not be performed. * for women : pregnancy or current breastfeeding

Keywords: sma spinal muscular atrophy neuromuscular disease
collecting tissue samples for future research from women undergoing surgery for breast cancer

Conditions: Breast Cancer

Summary: rationale: collecting and storing samples of tumor tissue from patients with breast cancer to study in the laboratory may help doctors learn more about cancer. purpose: this phase i study is collecting tissue samples for future research from women undergoing surgery for breast cancer.

objectives: primary * collect breast tissue for future research from women undergoing surgery for breast cancer. secondary * create microarrays by tumor type for internal use by specialized program of research excellence. outline: tumor tissue is collected and analyzed to create microarrays by tumor type for future research studies. projected accrual: a total of 1,250 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * undergoing surgery for breast cancer

Keywords: breast cancer