Kornimate/medical-research-clean huggingface dataset:
endoscopic treatment of biliary strictures after ltx: balloon dilatation versus stent placement

Conditions: Biliary Obstruction; Biliary Stenosis; Biliary Stricture

Summary: background and study aims: biliary strictures are a major cause of morbidity following liver transplantation with an overall incidence between 10 and 30 %. up to now biliary strictures were dilated subsequently one to three plastic stents with a diameter of eight to ten f were inserted. in general, stents were exchanged in two to three months intervals over one year. in the present prospective controlled study, efficacy and complication rates of balloon dilation have been compared with dilation plus stenting. patients and methods: xy patients with high-grade biliary strictures (anastomotic and non-anastomotic) were enrolled in this prospective study in random order. x patients were treated by endoscopic balloon dilatation and y by balloon dilatation plus plastic stent placement in six to eight weeks intervals. the primary end point was permanent opening of the biliary obstruction of 12 months. number of endoscopic interventions and complications of the procedures were monitored.

endoscopic treatment was performed by experienced endoscopists who had each performed more than 1000 ercp procedures. the procedure was performed with the patient under general anesthesia with propofol. a stenosis was considered to be present if the cholangiogram showed strictures with a narrowing of the anastomosis or the proximal donor duct site of the anastomosis and incomplete distal runoff of the contrast agent. the patients were divided into two groups: 1) balloon dilatation of the stricture, 2) balloon dilatation plus plastic stent placement. in both groups, endoscopic treatment of the patients comprised sphincterotomy, consecutive dilation of stenosis up to 10 f, removement of occluding material from choledochus duct using a balloon catheter if necessary, and repetitive balloon dilatation of the anastomosis stricture or of the non-anastomotic proximal donor duct stricture to 18 f at the first intervention and to 24 f in the following interventions. the second group of the patients were additionally treated by large-diameter (10 f) plastic stent placement after balloon dilatation. this procedure was repeated in 6 - 8 weeks intervals in both groups.

Eligibility criteria:
inclusion criteria: * liver transplanted patients with diagnosis of biliary obstruction based on endoscopic cholangiopancreaticography older than 18 years male and female exclusion criteria: * patients with multiple organ transplantation

Keywords: liver transplantation biliary strictures ercp
weekly topotecan in the first-line treatment of elderly patients with small cell lung cancer

Conditions: Lung Cancer

Summary: in this phase ii trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens

upon determination of eligibility, all patients will be receive: * topotecan

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * biopsy-proven small cell lung cancer, extensive stage disease * age \> 65 years * no previous chemotherapy or radiation therapy. * measurable or evaluable disease. * adequate bone marrow, liver and kidney function. * must be \> 4 weeks from previous major surgery * must give written informed consent prior to study entry. exclusion criteria: you cannot participate in this study if any of the following apply to you: * meningeal involvement * serious active infections * serious underlying medical conditions * other active neoplasms 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.
a safety, tolerability, and pharmacokinetic study of nd0612 delivered as a continuous subcutaneous in parkinson's disease patients

Conditions: Parkinson's Disease

Summary: an open-label randomized study to evaluate the safety, tolerability, and pk of low and high single doses of nd0612 (i.e. ld/cd ratio 60/7.5 mg/ml and 60/14 mg/ml), as well as the combination with oral entacapone (concomitant catechol-o-methyl transferase \[comt\] inhibitor) in pd subjects with well-defined morning "off" and a good response to ld. exploratory efficacy parameters were collected (early evidence of effectiveness as part of phase 1).

pd subjects were randomized in low or high ld dose study group in 1:1 ratio. each patient received singe doses nd0612 over 3 days: day 1. ld/cd 60/7.5 mg/ml, day 2. ld/cd 60/14 mg, and day 3. ld/cd 60/14 mg/ml with entacapone.

Eligibility criteria:
inclusion criteria: 1. male and female pd patients of any race aged 30 to 80 years 2. pd diagnosis consistent with the uk pd society brain bank criteria. 3. stable doses of anti pd drugs for at least 30 days 4. pd patients with well-defined morning "off" and a good response to ld 5. mmse score \> 26 6. no clinically significant medical, psychiatric or laboratory abnormalities exclusion criteria: 1. atypical or secondary parkinsonism. 2. acute psychosis or hallucinations. 3. subjects treated with neuroleptics 4. history of melanoma or significant skin disorders. 5. prior neurosurgical procedure for pd. 6. patients with a history of drug abuse or alcoholism 7. clinically significant ecg abnormalities. 8. renal or liver dysfunction 9. subjects who have participated in another clinical study within 30 days

Keywords: motor fluctuations levodopa pharmacokinetics levodopa and carbidopa solution continuous subcutaneous delivery
prospective observational study assessing treatment and outcomes of patients with prediabetes

Conditions: Prediabetes

Summary: the purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices.


Eligibility criteria:
inclusion criteria: * age 18 years or older * diagnosis of prediabetes based on hemoglobin a1c and/or fasting plasma glucose * established patient of principal investigator's clinical practice * bmi greater than or equal to 25 kg/m2 * physically able to participate in a diabetes prevention program exclusion criteria: * has prior diagnosis of diabetes * is pregnant or is planning to become pregnant in the next 6 months * is currently taking a medication prescribed for diabetes prevention * is currently enrolled in a formal diabetes prevention or weight loss program

Keywords: prediabetes diabetes prevention
efficacy and safety trial of transcranial laser therapy within 24 hours from stroke onset (nest-3)

Conditions: Acute Ischemic Stroke

Summary: the purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (tlt) with the neurothera® laser system in the treatment of subjects diagnosed with acute ischemic stroke. the initiation of the tlt procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of acute ischemic stroke 2. subject is not a candidate for treatment with neurothrombectomy 3. initiation of the tlt procedure begins between 4.5 and 24 hours 4. baseline nihss score range: 7-17 5. full functional independence just prior to the present stroke episode 6. negative pregnancy test in females of childbearing potential 7. subject informed consent obtained prior to enrollment into this study exclusion criteria: 1. evidence of an intracranial, subdural, or subarachnoid hemorrhage 2. acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes 3. seizure at stroke onset or within the 7 days prior to stroke onset 4. sustained blood glucose \>300 or \<60 mg/dl 5. sustained hypertension (sbp \>220 mmhg or dbp \>140 mmhg) 6. sustained hypotension (sbp \<80 mmhg or dbp \<50 mmhg) 7. a presumed and/or confirmed septic embolus 8. history of cns vascular disease (e.g. aneurysm, avm) or history of cns disease or damage (e.g. neoplasm or dementia) which may influence the subject's outcome assessment. 9. head implant of any kind 10. significant skin condition of the scalp (eg. psoriasis) 11. use of any intravenous or intra-arterial thrombolytic medication 12. use of any diagnostic or therapeutic interventional neurovascular procedure 13. female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.

Keywords: stroke
the role of hydrosalpinx in recurrent miscarriage

Conditions: Abortion, Spontaneous; Miscarriage, Recurrent; Hydrosalpinx

Summary: miscarriage affects one in five pregnancies and little progress has been made in understanding and treating this distressing condition. c. trachomatis is the most common sexually transmitted infection in the uk. c. trachomatis infection can have serious health consequences, including fallopian tube damage. untreated c. trachomatis infection and tubal damage have been associated with miscarriage and adverse pregnancy outcomes such as preterm birth, low birth weight and stillbirth. a cohort study is needed to establish the prevalence of tubal disease in women with recurrent miscarriages. hycosy will be performed to identify tubal disease and establish the magnitude of the problem in the recurrent miscarriage population. the prognosis of tubal disease on miscarriage and other obstetric outcomes, and the role of medical interventions such as tubal surgery (to treat hydrosalpinx) on reducing miscarriage and adverse obstetric outcomes will also be studied. objectives 1. establish the prevalence of hydrosalpinx in the recurrent miscarriage population. 2. establish the prognosis of women diagnosed with recurrent miscarriage with concurrent hydrosalpinx. 3. explore the role of tubal surgery for improving reproductive outcomes in women with recurrent miscarriage population and hydrosalpinx.


Eligibility criteria:
inclusion criteria: * age 18-45 * women diagnosed with recurrent miscarriage i.e. 2 or more miscarriages * ability to give informed consent exclusion criteria: * allergy to contrast media used for hysterosalpingo-contrast-sonogram * allergy to sonographic gel used for ultrasound scanning * anatomical anomaly meaning transvaginal ultrasound scan not possible * stenosed/occluded cervix meaning contrast media unable to be introduced via cervix * inability to give informed consent * pregnant at the time of recruitment * declined recruitment
effective lens position after cataract surgery

Conditions: Age-related Cataract

Summary: cataract patients were implanted with different types of intraocular lenses for grouping. ssoct scanning was used to measure elp and optometry.

cataract patients were implanted with different types of intraocular lenses for grouping. perform ssoct scan that was used to measure effective lens position and optometry at different postoperative follow-up time .

Eligibility criteria:
inclusion criteria: * a.diagnosed as cataract; * b.implanted intraocular lens: sn6cws, aspira-aa, mi60; * c.cataract phacoemulsification and intraocular lens implantation. exclusion criteria: * a.combined with corneal opacity, glaucoma, uveitis, retinal detachment and other eye diseases; * b.a history of intraocular surgery or trauma other than cataract surgery; * c.intraoperative complications such as tearing of the capsule and iol failure to implant; * d.endophthalmitis, corneal endothelial decompensation and other postoperative complications; * e.those with incomplete data collected during the follow-up period of postoperative patients.
the effect of adipose-derived stem cells for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups: 1. partial fat pad harvest with adipose-derived stem cell (adsc) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy. 2. standard arthroscopic treatment (above) without cell transplant.

adipose-derived stem cells (adsc) may be beneficial to patients with oa because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties. early studies show promising clinical results using adscs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment. the investigators aim to determine whether adsc transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.

Eligibility criteria:
inclusion criteria: * age between 35 and 70 years-old * patient is scheduled to undergo one or a combination of the following procedures: * meniscal debridement or partial menisectomy * meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy * removal of loose bodies * chondroplasty * synovectomy * soft tissue releases for flexion or extension contracture. * diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (kellgren-lawrence grade 2 or 3) * \< 6 months of knee pain or \< 6 months of a significant exacerbation of existing knee pain * physical examination findings consistent with the proposed surgical procedure. * failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections exclusion criteria: * age \ 70 years old * radiographs demonstrating either no, little or severe osteoarthritis (kellgren-lawrence grade 0, 1 or 4) * previous injury or surgery to the infrapatellar fat pad (assessed by mri) * patient scheduled to undergo any concomitant surgical procedures with the exception of: * meniscal debridement or partial menisectomy * meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy * removal of loose bodies * chondroplasty * synovectomy * soft tissue releases for flexion or extension contracture * prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, autologous chondrocyte implantation, etc) or meniscal transplant/implant * previous arthroscopy within 1 year * subchondral edema

Keywords: stem cell knee pain osteoarthritis arthritis adsc fat stem cell
a study of neorecormon (epoetin beta) in patients with end stage renal disease.

Conditions: Anemia

Summary: this single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of neorecormon. patients on dialysis receiving neorecormon, and with a hemoglobin level \<105g/l, will be treated with subcutaneous neorecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/l. heart function and quality of life will be measured before and after anemia correction. the anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * end-stage renal disease; * on renal dialysis \>= 3 months; * receiving neorecormon treatment \>= 3 months; * hb stable and \ 160g/m2. exclusion criteria: * unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months; * use of any esa other than neorecormon; * acute infection; * use of iv neorecormon.
study of intravenous administration of allogeneic adipose stem cells for covid-19

Conditions: Covid19

Summary: this study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with covid-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. this data will be used for fda ind filings and pursuit of a bla.

this study is single arm, non-randomized phase 1 study of the safety and preliminary efficacy of psc-04, an adipose-derived allogeneic mesenchymal stem cell. the outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. study objectives: primary: to evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with covid-19 disease and respiratory distress. secondary: to evaluate a set of secondary safety and efficacy outcome variables to give guidance in assessing the risk/benefit ratio in patients with covid-19 respiratory distress.

Eligibility criteria:
inclusion criteria: * admitted to hospital as in-patient (ward or icu) * respiratory distress - respiratory rate ≥ 30/minute (or pao2:fio2 \<300) * bilateral lung infiltrates (ct or frontal x-ray) * supplemental oxygen started but not intubated or ventilated * covid-19 (sars-cov-2) antigen test positive (fda-approved test); * cdc confirmation not necessary * time from enrollment to treatment must be less than 24 hours * age: 18-80 years * gender: any * suitability for cellular therapy: in the opinion of the investigator or the sponsor the patient is suitable for cellular therapy * cognitive function: able to understand and willing to sign informed consent form or legally authorized representative or surrogate exclusion criteria: * intubation / ventilation * current therapy is working, and patient is clinically improving * disease conditions: heart failure severe (ny heart association classification iv); clinical evidence of left heart failure or volume overload as a primary explanation for the bilateral pulmonary infiltrates; any disease or condition other than current respiratory covid-19 disease for which 6-month mortality is estimated to be greater than 50%; moderate to severe liver failure; severe chronic respiratory disease or the use of home oxygen use prior to this current illness; currently receiving extracorporeal life support (ecls/ecmo) * past disease conditions: any history of malignancy within the last 2 years (except for patients in remission or cured of the malignancy); lung transplant patient or lobectomy; deep venous thrombosis or pulmonary embolism within past 3 months; history of splenectomy * other experimental conditions: currently enrolled or treated in last 60 days in another clinical study * consent issues: do not resuscitate (dnr) order in place; not willing to follow lung protective ventilation strategy, if needed * concurrent disease or circumstances that investigator or sponsor judges to be an unacceptable risk to patient health or a confounding variable to assessment or problem in completion of trial.

Keywords: adipose stem cell covid19 covid-19 pneumonia
risk factor involved in knee osteoarthritis (koa)

Conditions: Knee Osteoarthritis

Summary: clinical study regarding the incidence and severity of knee osteoarthritis (koa) in a certain area from south-eastern europe. aim of the clinical study: to determine the koa grade through x-ray studies, to perform nuclear magnetic resonance (nmr) analysis to assess the koa severity and to determine the level of significant parameters in the synovial liquid extracted from the patients presenting koa.

clinical study regarding the incidence and severity of koa in a certain area from south-eastern europe. clinical study on 85 patients out 373 participants that were screened, chosen based on inclusion/exclusion criteria. aim of the clinical study: to determine the koa grade through x-ray studies, to perform nuclear magnetic resonance (nrm) analysis to assess the koa severity. data corroboration of the koa degree with the results of the blood samples analysis, looking for the influence of the metabolic syndrome (mets) parameters - high-density lipoprotein (hdl), low-density lipoprotein (ldl), total cholesterol, triglycerides, glycemia, and then the body mass index (bmi). in the meantime, there is intended to associate the environment of origin of the patients from the trial group with the koa incidence and severity. to determine the level of significant parameters in the synovial liquid extracted from the patients presenting koa, analysis of the degradation products present in the synovial fluid of patients with koa, such as free radicals, like reactive oxygen species (ros) and reactive nitrogen species (rns) and their influence on the severity of the pathology.

Eligibility criteria:
inclusion criteria: * male and female with knee pain (complaints); presented symptoms and clinical signs corresponding to koa and had knee x-rays in the anteroposterior view and nuclear magnetic resonance (nmr) performed for setting the diagnosis with unilateral or bilateral knee pain; patients with clinically determined and recorded values of total cholesterol, low-density lipoprotein (ldl), high-density lipoprotein (hdl), triglycerides and the glycemia in the clinical observation sheet. exclusion criteria: * patients presenting lower limb arthroplasties; history of lower limb or pelvis fractures and previous knee surgery: ligamentoplasty, meniscectomy; inflammatory rheumatic diseases such as rheumatoid polyarthritis; other major conditions like malignant illness.