Kornimate/medical-research-clean huggingface dataset:
study to evaluate suprachoroidally administered cls-ax in the treatment of neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered cls-ax 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vascular endothelial growth factor (vegf) standard of care therapy. only one eye will be chosen as the study eye.

phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered cls-ax 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vegf standard of care therapy. active-control will be 2 mg intravitreal injections of aflibercept dosed per the eylea prescribing information. only one eye will be chosen as the study eye.

Eligibility criteria:
key inclusion criteria: * diagnosis of neovascular age-related macular degeneration (namd) in the study eye within 36 months of visit 1. * subfoveal choroidal neovascularization (cnv) secondary to namd of any lesion type in the study eye that shows total lesion area ≤30 mm2, cnv component area of ≥50% of the total lesion area, and and cnv must not be associated with subfoveal hemorrhage, subfoveal fibrosis, or subfoveal atrophy. * previous treatment in the study eye with between 2 and 4 anti-vegf intravitreal injections for namd (faricimab, ranibizumab, bevacizumab, brolucizumab, or aflibercept) per standard of care within 6 months of visit 1. * history of response to prior intravitreal anti-vegf treatment in the study eye. * etdrs bcva of between 20 and 80 letters (inclusive) in the study eye. key exclusion criteria: * etdrs bcva \<20 letters in the study eye. * central subfield thickness \> 400 μm or retinal pigment epithelium detachment thickness \>400 μm on sd-oct in the study eye. * subretinal hemorrhage, fibrosis or atrophy of \>50% of the total lesion area and/or that involves the fovea on fundus fluorescein angiography and/or color fundus photography in the study eye. * cnv due to causes other than amd, such are ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis, in the study eye. * any history of macular pathology unrelated to amd affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye.

Keywords: amd wet amd suprachoroidal tyrosine kinase inhibitor microinjector suprachoroidal space (scs)
18f-l-fluoro-dopa pet/ct scan localization of focal pancreatic lesions in subjects with hyperinsulinemic hypoglycemia

Conditions: Congenital Hyperinsulinism (CHI); Beckwith-Wiedemann Syndrome; Insulinoma

Summary: this purpose of this study is to determine the ability of an 18f-fluoro-l-dihydroxyphenylalanine (18f-dopa) pet (positron emission tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, beckwith wiedemann syndrome and suspected insulinoma. safety data will be collected.

patients with hyperinsulinemic hypoglycemia are at risk for neurological damage due to hypoglycemia. early surgical intervention can be preventative. f-dopa pet may be able to detect of a focal lesion prior to surgical intervention and be used during surgical planning to guide the surgical procedure.

Eligibility criteria:
inclusion criteria: * subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation. * subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery exclusion criteria: * pregnant or lactating females * any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study * subjects who are not a candidate for pancreatic surgery

Keywords: hypoglycemia hyperinsulinism (hi) f-dopa pet 18-f dopa 18f-l-fluoro-dopa 18f-fluoro-l-dihydroxyphenylalanine focal pancreatic lesions congenital hyperinsulinism beckwith wiedemann syndrome insulinoma hyperinsulinemic hypoglycemia f-dopa pet chi (congenital hyperinsulinism)
optimization and multi-site feasibility of yoga for chronic pain in people in yogamat-ii - phase i

Conditions: Opioid Use; Chronic Pain

Summary: phase 1 - most preparation phase: 1. to conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20. 2. establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial. 3. demonstrate our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer components; d) run classes; and e) collect follow-up assessments.

in phase 1, we will enroll 10 participants at each recruitment site (n=20). the purpose of phase 1 (most preparation phase) is to allow us to establish and refine procedures at these new sites and document aspects of feasibility, including our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer these components; d) run classes; and e) collect follow-up assessments. enrollment period for this phase will last approximately 4 months.

Eligibility criteria:
inclusion criteria: * enrolled in methadone maintenance (mmt) or buprenorphine/naloxone (bup) treatment for \> 3 months * plan to continue treatment for next 6 months * chronic pain, defined as pain for at least half the days over the previous three months, a mean score of 4 or higher on the brief pain interference scale (bpi; with reference to chronic pain), and pain severity of 4 or higher on a visual analog scale (0-10) indicating "worst pain in the last week." pain severity score will also refer to the areas of their body in which they have chronic pain. * aged \> 18 * proficiency in english sufficient to engage in informed consent in english, understand classes taught in english, and read short sentences * available at least one of the times study classes are offered. exclusion criteria: * currently taking yoga classes or practicing yoga at home once per week or more often. * medical conditions that would make participation in yoga unsafe or not possible, including active malignancy treatment, fracture, recent joint surgery, use of assistive ambulatory devices other than a cane. . (in cases where this is unclear, site pi will make final determination based on available evidence.) * severe or progressive neurologic deficits. (in cases where this is unclear, site pi will make final determination based on available evidence.) * other severe disabling chronic medical and/or psychiatric comorbidities deemed by the site pi on a case-by-case basis to prevent safe or adequate participation in the study (e.g., cognitive impairment that prevents a participant from understanding assessments; history of disruptive behavior in medical settings; severe disabling heart failure or lung disease) * surgery requiring overnight hospitalization planned in the next 3 months * pregnancy * plan to move out of the area within 6 months. * homeless, defined as any time in the past month sleeping in a shelter or on the street.
transoral gastric volume reduction as an intervention for weight management

Conditions: Obesity

Summary: the purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of tgvr performed using the bard restore suturing system


Eligibility criteria:
inclusion criteria: * male, female; ages \>18yrs - £ 60 yrs * bmi 30-45 kg/m2 * history of obesity for 5 yrs; attempts at weight control ineffective * weight stable * willing to comply with study requirements * agrees to not have any additional weight loss surgery, reconstructive surgery or liposuction for one year following procedure * sign informed consent form exclusion criteria: * women of childbearing age not practicing effective birth control method or pregnant or lactating * mallampati score = 4 * uncontrolled hypothyroidism * previous interventional/surgical treatment of obesity; any prior gastric surgery * history of diabetes for \> 10 yrs or difficult to control diabetes * presence of hiatal hernia * congenital or acquired anomalies of the gi tract * severe cardiovascular, cerebrovascular, or cardiopulmonary disease * chronic or acute upper gastrointestinal bleeding conditions * helicobacter pylori positive * immunocompromised * subjects with eating disorders * acute or chronic infection * significant movement limitations * not a candidate for conscious or general anesthesia * active substance abuse * life expectancy \< 2 years * enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study

Keywords: weight loss transoral suturing experimental
endostar combined with mfolfox6 for first-line treatment of metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this study is to assess the efficacy and safety of endostar combined with mfolfox6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma) * at least one measurable lesion (recist criteria) * life expectancy ≥ 3 months * ecog performance status 0-2 * adequate hematologic function: anc ≥ 1.5×109 /l，hb ≥ 90 g/l，plt ≥ 100×109 /l * adequate renal function: cr ≤ 1.25×uln or creatinine clearance ≥ 60 ml/min * adequate hepatic function: bil ≤ 1.5×uln, alt/ast ≤ 2.5×uln, alkaline phosphatase ≤ 5×uln * patients have not previously received palliative chemotherapy, immunological/ biological treatment * no adjuvant chemotherapy in last six months * target lesion has not received local radiotherapy * written informed consent exclusion criteria: * diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma * evidence of serious or uncontrolled infection * serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) * pregnant or lactating women * women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy * allergic to any of the study drug * intestinal obstruction, intestinal perforation, or stroke within 3 months * participation in other clinical studies
efficacy and safety evaluation of a treatment consisting of peg interferon alfa + ribavirin + daclatasvir in hcv genotype 1 and 4 treatment naïve patients

Conditions: Hepatitis C

Summary: the purpose of this study is to determine whether 24 week treatment with the daclatasvir (dcv) in combination with pegylated-interferon alfa 2a (pegifnα-2a) and ribavirin (rbv) is safe and demonstrates rate of sustained virologic response at follow up week 24 (svr24) (defined as undetectable hcv rna at post-treatment week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegifnα-2a/rbv in a majority of study subjects


Eligibility criteria:
inclusion criteria: * patients chronically infected with hepatitis c virus (hcv) gt 1 or 4 * hcv rna viral load ≥ 10,000 iu/ml * naïve to prior treatment with any interferon formulation, ribavirin (rbv) or hcv direct antiviral agent * patients with compensated cirrhosis are permitted exclusion criteria: * infected with hcv other than gt 1 or 4 * evidence of decompensated liver disease * documented or suspected hepatocellular carcinoma (hcc) as evidenced by previously obtained imaging studies or liver biopsy * evidence of a medical condition contributing to chronic liver disease other than hcv * history of chronic hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment * laboratory values: 1. hemoglobin \< 12 g/dl (females) or \< 13 g/dl (males) 2. platelets \< 90 x 1000000000 cells/l 3. absolute neutrophil count (anc) \< 1.5 × 1000000000 cells/l 4. total bilirubin ≥ 34 µmol/l (unless due to gilbert's disease)
topical compounded pain creams and pain perception (topcapp)

Conditions: Pain

Summary: to evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.

this is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.

Eligibility criteria:
inclusion criteria: * participants must be diagnosed with an icd9 code indicative of chronic pain. * participants must be starting a new regimen of topical therapy with multiple compounded agents. * participants must be expecting to receive therapy for at least 12 weeks. * participants must be between 18 and 65 years of age. * participants must be able to provide sound written and verbal informed consent. exclusion criteria: * participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription. * participants must not be pregnant or breastfeeding women. * participants must not have a diagnosis of cancer within the past 5 years.

Keywords: topical compounded pain creams and pain perception
efficacy and safety study of maintenance treatment with rhtpo in thrombocytopenic subjects with itp

Conditions: Thrombocytopenia; Immune Thrombocytopenia; Idiopathic Thrombocytopenic Purpura

Summary: the purpose of this study is to evaluate the efficacy and safety of rhtpo in the maintenance treatment of itp, to explore the appropriate dosing interval of the maintenance treatment of rhtpo .

the eligible subjects with itp firstly will receive a pre-treatment of rhtpo 300 iu/kg once daily up to 14 days. the subjects with two consecutive platelet counts above 50×10\^9/l in the pre-treatment period will begin to receive maintenance treatment of rhtpo 300 iu/kg for 12 weeks. in the period of maintenance treatment, starting dosing interval of rhtpo is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10\^9/l～100 ×10\^9/l. subsequently, subjects will stop treatment of rhtpo and be followed up for 4 weeks after maintenance treatment. platelet count, bleeding and other symptoms will be evaluated before and after treatment. platelet transfusion will be administered to subjects with active bleeding symptoms. toxicity will be monitored continuously during the entire study. safety will be assessed by adverse events and laboratory tests.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura). * subject with resistance to or relapse after glucocorticoid in the treatment of itp, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy. * two consecutive platelet counts (not in the same day) \< 30×10\^9/l. * subject is willing and able to provide written informed consent. exclusion criteria: * pregnancy or breast feeding. * having a medical history of thrombosis. * significant abnormal cardio-pulmonary function. * abnormal liver and kidney function: * a serum creatinine concentration≥ 176.8µmol/l (1.5mg/dl); * a serum aminotransferase concentration: more than 2.0 times the upper limit of the normal range. * a serum bilirubin concentration: more than 2.0 times the upper limit of the normal range. * synchronous tumor. * cannot adopt adequate contraceptive precautions during the course of the study. * any other treatment drugs for itp are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ). * any other situation that is not suitable for participating in the trial according to the judgment of the investigator .

Keywords: itp rhtpo
kinetics of serum β-d-glucan during peritonitis with candida in resuscitation

Conditions: Peritonitis Infectious; Candida Infection

Summary: intraabdominal fungal infections with candida are constantly increasing. their diagnosis and treatment is difficult. morbidity and mortality are high. β-d-glucan has been proposed as a marker of systemic fungal infection in candidemia. moreover, its kinetics is associated with therapeutic success. on the other hand, there are no data on intraabdominal infections that are much more frequent. the objective of the study is to evaluate the initial levels of β-d-glucan and its daily kinetics during the treatment of fungal peritonitis in resuscitation compared to a control group with a yeast-free peritonitis.


Eligibility criteria:
inclusion criteria: * major patient (age ≥ 18 years) * community or associated peritonitis, operated and hospitalized in resuscitation * affiliation to a social security scheme exclusion criteria: * allergy known to echinocandins * dying patient * limitation of care * predictable duration of follow-up ≤ 10 days * transfusion within 3 months * patient minor, patient under guardianship or curatorship
pd2i analysis of heart rate variability in competitive sports

Conditions: Autonomic Dysfunction

Summary: this is a double blind observational analysis of changes in heart rate variability using pd2i analyser in competitive athletes during strenuous exercise and competition.


Eligibility criteria:
inclusion criteria: * age \>18 years, as determined by birth date given on participation form. * actively involved in competitive athletics * able to give informed consent exclusion criteria: * any known prior autonomic dysfunction * history of seizures or taking anti-seizure medication * known learning disability or attention deficit disorder * chronic heart conditions such as arrhythmias or valvular disease * history of diabetes mellitus * taking any prescription stimulants such as ritalin, focalin, etc. * use of any performance-enhancing drugs * any deviation from normal found on the pre-participation physical exam such as the presence of a murmur or hypertension.

Keywords: heart rate variability autonomic dysfunction exercise sports competition athletes
clinical prediction rule for clinical lumbar instability

Conditions: Low Back Pain

Summary: the aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises. question: what clinical characteristics are associated with patients that respond positively to a program of core stabilization exercises? hypothesis: clinical characteristics that show a decrease in trunk motor control will be associated with a positive response to stabilization exercises.

clinical identification of individuals with mechanical low back pain who would benefit from a program of stabilization exercises has been a struggle for the physical therapy profession. while changes in trunk muscle recruitment and motor control have been linked to patients with chronic low back pain and hypothesized to be adaptations for spinal instability, this has not been systematically established. however, a connection between spinal instability, poor trunk motor control, and low back pain is plausible. the real problem lies with the clinical identification of the subgroup of patients in either the acute or chronic phases of low back dysfunction who would most benefit from this approach to intervention. in creating their preliminary clinical prediction rule, hicks et al (2005), looked at many variables including patient demographics and characteristics, hip and trunk motion, special tests for instability, and functional measures of muscle performance. however, measures of the performance of core stabilizing muscles and assessment of trunk dynamic control/ coordination were not included as potential variables. the aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises.

Eligibility criteria:
inclusion criteria: 1. duration of the current episode of low back pain less than 3 months, 2. average pain intensity over past 3 days at least 4 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale, 3. no medical intervention for low back pain in last 6 months, 4. oswestry score greater than 25% exclusion criteria: 1. permanent structural spinal deformity (e.g., scoliosis) 2. history of spinal fracture or diagnosis of osteoporosis 3. diagnosis of inflammatory joint disease 4. signs of systemic illness or suspected non-mechanical lbp (i.e. spinal tumor or infection) 5. previous spinal surgery 6. frank neurological loss, i.e., weakness and sensory loss 7. history of neurologic disease that required hospitalization, 8. active treatment of another medical illness that would preclude participation in any aspect of the study or any lower extremity injury that would potentially alter trunk movement in standing 9. leg length discrepancy of greater than 2.5 cm. 10. pregnancy 11. vestibular dysfunction

Keywords: low back pain core stabilization physical therapy
multi-center study of iron overload: survey study (mcsio)

Conditions: Sickle Cell Disease; Thalassemia; Diamond-Blackfan Anemia

Summary: the purpose of this study is to demonstrate that a sufficient number of iron-overloaded thalassemia (thal), sickle cell disease (scd)and diamond blackfan anemia (dba) populations with similar duration of chronic transfusion, and age at start of transfusions would be available for a confirmatory study. the study will examine the hypothesis that a chronic inflammatory state in scd leads to hepcidin- and cytokine-mediated iron withholding within the res (reticuloendothelial system), lower plasma ntbi (non-transferrin bound iron) levels, less distribution of iron to the heart in scd.

a detailed iron burden, transfusion and chelation history will be obtained from chart review or from participant recall. iron burden data will include: 1) documentation of liver iron, and 2) average annual ferritin values. transfusion data will include: (1) age at onset of regular transfusions, (2) years of chronic transfusion therapy, and (3) pre-transfusion hb calculated as average of all assessments for each year.

Eligibility criteria:
inclusion criteria: * 10-20 years of transfusion (defined as 0.2-0.6mg fe/kg/day exposure with annual ferritin levels greater than 2500 in at least 60% of years of chronic transfusion); * 0 to 9 years old at the initiation of chronic transfusions; no exchange transfusions in the previous 6 months * iron overload documented by either liver biopsy, mri or squid with estimated lic of greater than 7 mg/g dry wt in the previous 6 months or ferritin level greater than 1500mg/dl. exclusion criteria: * patients with hbsc, hbs/β thalassemia * pacemaker (active or inactive) or other implanted magnetic devices, severe claustrophobia, or other contraindications to mri; unable to remove ferro-magnetic objects from the body in regions to be imaged (e.g., jewelry or piercing) * presence of any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment; * any chronic inflammatory illness other than the scd, thal or dba; * any acute illness within a 14 day period prior to blood sampling; * patients receiving intensive chelation in the 6 months prior to enrollment including deferoxamine 24 hours per day, 7 days per week or combination treatment with 2 chelators * pregnancy