Kornimate/medical-research-clean huggingface dataset:
a phase 1 study of abc008 in ascending (single ascending dose/multiple ascending dose) study in patients with (ibm)

Conditions: Inclusion Body Myositis

Summary: an open-label, ascending dose study for adult patients with inclusion body myositis (ibm).

participants who successfully complete the sad eot visit, and have no emerging safety issues, will be eligible to enroll in part 2 (mad). eligible participants for the mad part will have inclusion and exclusion criteria (same as those for part 1) reviewed prior to dosing on mad day 1. participants who successfully complete the mad eot visit, and have no emerging safety issues, will be eligible to enrol in part 3, mad extension. after the final mad visit (w48), participants will have the option to continue on to part 3 mad extension. for part 3 (mad extension), participant dosing will be at 8-week intervals starting at day 1. duration of dosing in part 3 will be up to approximately 80 weeks (18 months), or until a new long-term extension study has been initiated. the smc will review all participant safety data approximately every 6 months while the part 3 dosing continues.

Eligibility criteria:
key inclusion criteria: * diagnosis of either clinico-pathologically defined ibm, clinically defined ibm, or probable ibm according to the european neuromuscular center (enmc) ibm 2011 * able to arise from a chair (with or without armrests) without support from another person or device * able to ambulate at least 20 feet / 6 meters with or without assistive device exclusion criteria: * taking \> 7.5 mg prednisolone (or equivalent) or on intravenous immunoglobulin (ivig) or other immunosuppressants within the last 3 months. topical, nasal, and ocular corticosteroids are allowed unless they are being widely applied or the severity of the underlying condition makes them unsuitable in the investigator's opinion. local steroid injections are allowed

Keywords: inclusion body myositis ibm
the capillary index score trial

Conditions: Acute Stroke; Brain Ischemia; Ischemic Stroke

Summary: this study seeks to investigate the capillary index score (cis) to further improve patient selection of endovascular treatment (evt) in acute ischemic stroke (ais). the hypothesis or idea being tested: patients with favorable cis who are successfully revascularized with evt can have successful outcomes with an extended time window for treatment.

this study is trying to look at how the well-being of the patient following treatment is influenced by peripheral blood supply (collateral flow) to the area lacking primary blood flow due to the clot. treatment of ais includes evt and medical treatment. evt is typically not offered to patients after 6 hours of the onset of symptoms. the current study is based on the belief that patients can be successfully treated with the evt up to 8 hours, as long as they have good peripheral blood flow (collateral flow) to the area of tissue blocked of the primary blood supply. the study will evaluate the ability of the capillar index score (cis) to identify patients who can be successfully treated with evt. the cis quantifies blood supply to the ischemic area from peripheral vessels (collateral flow) based on diagnostic cerebral angiogram. patients are graded on a scale from 0-3, with 0 and 1 considered a poor cis (pcis) and 2 and 3 considered a favorable cis (fcis). all patients will be treated with evt and medical treatment consistent with national guidelines. the primary endpoint is the clinical outcome at 90 days between fcis group versus pcis group. the secondary endpoint is the influence of successful revascularization on outcomes for patients with fcis or pcis.

Eligibility criteria:
inclusion criteria: 1. anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (m1) 2. within 24 hours of onset of symptoms 3. nihss score is 8 or greater exclusion criteria: 1. contra-indication for iat found on initial ct 2. intracranial hemorrhage 3. stroke mimics (tumor, herpetic encephalitis, etc.) 4. more than 1/3 hypodensity on non-enhanced head ct prior to intervention 5. aspect score less than 6 6. pre-existing disability defined as modified rankin scale (mrs) score more than 2 7. pregnant women

Keywords: capillary index score acute ischemic stroke collateral circulation cerebral ischemia diagnostic imaging
benefix drug use results survey [all-case surveillance]

Conditions: Hemophilia B

Summary: the survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch. 1. occurrence status of adverse events 2. factors that may influence the safety 3. efficacy in addition, the following occurrence statuses will be investigated as priority items of the survey: incidence rate of inhibitor, reduction in drug, efficacy, allergic reaction, and thrombosis.

patients with hemophilia b (congenital blood coagulation factor ix deficiency) who are administered this drug. patients with hemophilia b are either patients for whom treatment was already started with a blood coagulation factor ix product ("previously treated patients": hereinafter, "ptps") or patients who have no history of treatment with a blood coagulation factor ix product in the past and for whom treatment will be started with this drug for the first time ("previously untreated patients": hereinafter, "pups"). the definition of pups in this survey is "patients in whom the total number of days of administration of a blood coagulation factor ix product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "eds") or less."

Eligibility criteria:
inclusion criteria: * all patients with hemophilia b scheduled to receive treatment with benefix will be eligible for the surveillance. * no patient will be excluded because of prior inhibitor history; however, complete patient history and demographics will be collected. exclusion criteria: * patients not administered benefix.

Keywords: benefix regulatory post marketing commitment plan
bioequivalence of empagliflozin and metformin given as a fixed dose combination compared to single tablets

Conditions: Healthy

Summary: the primary objective of this trial is to establish bioequivalence of two fixed dose combination (fdc) tablets (containing medium dose empagliflozin/500 mg metformin \[test 1\] and low dose empagliflozin/500 mg metformin \[test 2\]) and of the single tablets (medium dose empagliflozin tablets + glucophage® 500 mg tablet \[reference 1\] and low dose empagliflozin tablet + glucophage® 500 mg tablet \[reference 2\]) when administered together after a high fat, high caloric meal. the assessment of safety and tolerability will be an additional objective of this trial.


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects 2. subjects must be able to understand and comply with study requirements 3. age 18 to 50 years 4. body mass index (bmi) 18.5 to 29.9 kg/m2 exclusion criteria: 1. any relevant deviation from healthy conditions
mypeeps lite trial

Conditions: HIV/AIDS

Summary: this study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (n=2,500), diverse national sample of high-risk young men who have sex with men (ymsm) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy of the mypeeps mobile intervention on reduced incident hiv infections in comparison to a standard of care condition and to examine the degree to which reduced incident hiv infections occurs in the context of potential multilevel moderators and conceptual mediators. this is key to advancing hiv prevention among hiv-negative us persons at extremely high-risk for hiv seroconversion.

in direct response to rfa-ai-21-018, limited interaction targeted epidemiology (lite-2): to advance hiv prevention (ug3/uh3 clinical trial optional), we proposed to harness innovative electronic methods to conduct a large, rigorous national study collecting and contextualizing epidemiological hiv incidence data in young men who have sex with men (ymsm) and testing the efficacy of mypeeps mobile, an evidence-based, digitally delivered mhealth sexual risk reduction intervention on hiv incidence. we proposed to establish a large national cohort of 2,500 racially and ethnically diverse ymsm 16-29 years old, the age ymsm are most susceptible to hiv acquisition to identify theoretically-driven correlates of hiv seroconversion among a key population experiencing a disproportionate number of new hiv diagnoses. randomized controlled trials (rcts) are considered the gold standard for estimating treatment efficacy because randomization mitigates risk of bias by balancing measured and unmeasured confounders across treatment groups. however, rcts are costly, time-consuming, and can be challenging to conduct in certain context. we are therefore integrating the robust epidemiological data that we collected during the ug3 phase into the clinical trial design. that integration is a potentially appealing way to generate an external comparator cohort to increase the power of our rct to estimate the effect of mypeeps mobile on hiv incidence.

Eligibility criteria:
inclusion criteria: * be between 16-29 years of age; * sex assigned at birth is male and identify gender as male or non-binary; * understand and read english; * live within us and its territories; * own or have access to a smartphone; * self-report anal sex with someone who has a penis in the last 12 months; and * be hiv-negative or status unknown exclusion criteria: * individuals who identify as transgender
influence of intracranial lesions on bispectral index

Conditions: Supratentorial Brain Tumor

Summary: the purpose of this study is to assess whether bis values at return of consciousness are different in patients with or without brain tumors.


Eligibility criteria:
inclusion criteria: * patients undergoing elective craniotomy for removal of frontal or frontotemporal brain tumors. * control group: neurosurgical patients without intracranial pathology. exclusion criteria: * patient refusal * significantly increased intracranial pressure * uncontrolled arterial hypertension * significant coronary artery disease * anticipated difficult airway * decreased level of consciousness * existing motor weakness dominant arm/hand * impaired hearing * nausea, vomiting

Keywords: bispectral index lesions consciousness
bli1100 for the treatment of moderate to severe acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to compare the safety and efficacy of formulation bli1100 to its vehicle in the treatment of moderate-severe acne vulgaris.


Eligibility criteria:
inclusion criteria: * qualifying investigator's global assessment severity score * qualifying number of non-inflammatory lesions * qualifying number of inflammatory lesions exclusion criteria: * facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade * using medications that are reported to exacerbate acne * any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin * have a known hypersensitivity or previous allergic reaction to any of the components * patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days * patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures

Keywords: moderate to severe facial acne vulgaris
pulmonary hypertension registry switzerland

Conditions: Pulmonary Hypertension

Summary: registry data from ph-patients in switzerland, who have given consent to records for research purposes.


Eligibility criteria:
inclusion criteria: * patients with ph exclusion criteria: -
clinical trial testing buzzy bee vs vapocoolant during iv placement

Conditions: Intravenous Administration

Summary: the purpose of this study is to compare the anxiety and pain levels of patients when using buzzy with ice, vapocoolant, and placebo when inserting iv's line for iv fluids and/or phlebotomy in pediatric patients in the pediatric emergency department.


Eligibility criteria:
inclusion criteria: * need iv's line placement for iv fluids and/or phlebotomy exclusion criteria: * patients sensitive to cold i.e. raynaud's * critically ill patients * mentally challenged patients * gcs\< 15 * patient with altered sensation * patients needing more than one attempt at iv placement

Keywords: analgesic anxiolytic buzzy bee shot-blocker
hd12 for advanced stages

Conditions: Hodgkin´s Lymphoma

Summary: this study is designed to test (1) whether the beacopp dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.


Eligibility criteria:
inclusion criteria: * hodgkin´s lymphoma (histologically proven) * cs(ps) iib with one or both of the risk factors: 1. bulky mediastinal mass (\> 1/3 of maximum transverse thorax diameter) 2. extranodal involvement * cs(ps) iii, iv * written informaed consent exclusion criteria: * leukocytes \<3000/microl * platelets \<100000/microl * hodgkin´s disease as "composite lymphoma" * activity index (who) \< grade 2

Keywords: hodgkin´s lymphoma advanced stages
pulse-width modulation

Conditions: Spinal Fusion; Spinal Stenosis

Summary: the overarching aim of this project is to modulate the pulse-width during stimulation of pedicle screws and record the response thresholds associated with each pwm setting. during this initial phase of the investigation, no further data will be collected.

in vivo electrical stimulation of pedicle screws is a well-documented modality for evaluating potential breach of the pedicle wall. however, previous research has focused primarily on the stimulation threshold intensity required to elicit a neurophysiological response. other stimulation parameters, such as pulse-width, remain uninvestigated. the goal is to obtain data on the pulse-width vs. cmap relationship.

Eligibility criteria:
inclusion criteria: * a patient will be eligible for study participation once they have been booked for a surgery involving pedicle screw placement and intraoperative neuromonitoring. exclusion criteria: * the study excludes neonates, minors, pregnant women, prisoners and cognitively impaired patients.
a study of adding linagliptin to control glycemic variability and hba1c in peritoneal dialysis patients with type 2 diabetes(pdpd) with premixed insulin therapy

Conditions: Type 2 Diabetes Mellitus; Peritoneal Dialysis

Summary: in china, there are the most population of type 2 diabetes mellitus (dm) among the world and dm becomes currently the second cause for end-stage renal disease (esrd). nearly 50% of insulin-treated pd patients in clinical practice are treated with premixed insulin. glycemic control in them is very difficult to be achieved mainly due to the uremic status of these patients and glucose exposure from peritoneal dialysate, a higher glycemic variability and higher risk of hypoglycemia. linagliptin, unlike other dpp-4 inhibitors, has a primarily non-renal elimination route, and does not require dose adjustment for any level of impaired renal function. the aim of this study is to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy. this will be a randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy.which will be conducted in 8 diabetes centres and/or nephropathy departments in china. after a 4-week run- in period, 232 participants are randomized (1:1) to either premixed insulin combined with linagliptin (5mg/d) group (also named combined group) or premixed insulin alone group (also named insulin group) for 12 weeks. finally, the primary endpoint is glucose variability indicated by mage, secondary endpoints include hba1c, fpg, ppg, lage, sdbg, pt10.0, pt3.9, 1h fasting mbg, 3h postprandial mbg, insulin dosage, hypoglycemia and body weight.


Eligibility criteria:
inclusion criteria: 1. type 2 diabetic patients who were treated with insulin regimen; 2. ages eligible for study:18 years to 80 years; 3. the patients with end-stage kidney disease receiving a regular peritoneal dialysis for at least 3 months; 4. hba1c ranging from 6.5%-10.5% when screening and randomizing ; 5. body mass index ranging from 21 to 35 kg/m2. exclusion criteria: 1. having any severe acute or chronic diabetic complications 2. blood aminotransferase level rising up more than 2 times of the upper normal limit 3. any severe cardiac disease, severe systemic diseases or malignant tumour 4. female patients incline to be pregnant 5. being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs 6. poor compliance

Keywords: linagliptin premixedinsulin therapy peritoneal dialysis glycemic variability
clinical case study evaluating the efficacy and tolerability of a topical facial treatment on healthy females with fitzpatrick skin types v and vi

Conditions: Skin Smoothness; Radiance; Overall Appearance

Summary: this single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with fitzpatrick skin types v and vi and mild to moderate global facial radiance, skin smoothness, and overall appearance. the treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. eleven (11) healthy female subjects completed the clinical study.

this single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with fitzpatrick skin types v and vi and mild to moderate global facial radiance, skin smoothness, and overall appearance. the treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. the efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial radiance, skin smoothness, and overall appearance was evaluated by investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

Eligibility criteria:
inclusion criteria: * individuals with fitzpatrick skin type v and vi * individuals with mild to moderate global facial radiance, skin smoothness, and overall appearance (score 2 - 6 on a 10-point modified griffiths scale). * individuals willing to undergo a washout period of 3 days. exclusion criteria: * individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study. * individuals currently having or having a history of cold sores (herpes simplex) on the face.

Keywords: anti-aging fitzpatrick skin types v and vi skin rejuvenation
18f-fluorocholine positron emission tomography (pet) for the detection of parathyroid adenomas

Conditions: Hyperparathyroidism, Primary

Summary: this is a prospective single arm single center phase iii study evaluating the ability of 18f-fluorocholine to detect the location of parathyroid adenomas.

primary objective: i. to investigate the performance (accuracy) of 18f-fluorocholine pet in the detection of hyperfunctioning parathyroid glands in surgical patients with biochemically proven primary hyperparathyroidism. outline: participants will receive a single dose of 18f-fluorocholine at the time the participant undergoes a single imaging study using 18f-fluorocholine. study related procedures will end after the study visit. participants who undergo subsequent parathyroidectomy, will have the results reviewed and compared to the results from the imaging study

Eligibility criteria:
inclusion criteria: * age \>= 13 years. * biochemically proven hyperparathyroidism and an indication for surgery. * ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: * current pregnancy. * patients unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
effects of immunosuppression on hcv recurrence after living donor liver transplantation - comparative study between tacrolimus + mmf and tacrolimus + steroid

Conditions: Hepatitis C; Liver Cirrhosis

Summary: the aim of this study is to compare immunosuppression protocol of tacrolimus + mmf with that of tacrolimus + steroid for preventing recurrence of hepatitis c after living donor liver transplantation.


Eligibility criteria:
inclusion criteria: * recipient of living donor liver transplantation for hcv-related cirrhosis exclusion criteria: * abo blood type incompatible transplant case * renal dysfunction (serum creatinine \>2.0 mg/dl) * wbc \< 1,000/mm3 * hemoglobin \< 8 g/dl * platelet \<30,000 /mm3

Keywords: liver transplantation, hcv recurrence, immunosuppression
obelix study: a study of avastin (bevacizumab) in combination with xelox in patients with metastatic cancer of the colon or rectum.

Conditions: Colorectal Cancer

Summary: this single arm study will evaluate the efficacy and safety of a first-line regimen of avastin and xelox (oxaliplatin + xeloda) in patients with metastatic cancer of the colon or rectum. patients will receive 21-day cycles of treatment, comprising avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. patients with stable disease or complete or partial response may continue on avastin therapy. the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * locally advanced or metastatic colorectal cancer; * no previous treatment with chemotherapy for metastatic disease; * at least one measurable lesion. exclusion criteria: * radiotherapy to any site within 4 weeks before study; * untreated brain metastases or primary brain tumors; * clinically significant cardiovascular disease; * chronic daily treatment with high dose aspirin (\>325 mg/day); * other co-existing malignancies or malignancies diagnosed within last 5 years.