Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of 1550nm fractional laser treatment for acne scars in fitzpatrick type iv-vi skin

Conditions: Acne Scarring

Summary: fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. this study aims to test the efficacy and safety in darker skin types. patients are randomized to either the 10mj 40mj dosages and receive a total of five treatments at 17% one month apart. improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. side effects such as pigmentary abnormalities and pain are also evaluated.

background: ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. fractional lasers have less severe side effects but more moderate efficacy than ablative devices. studies were performed in individuals with fitzpatrick skin type i to vi. objective: to determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in fitzpatrick skin types iv to vi. methods: we conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type iv to vi, with a 1,550-nm erbium fractionated laser. patients were divided into two groups; one was treated with 10 mj and the other with 40 mj. five monthly laser sessions were performed. a patient questionnaire was distributed.

Eligibility criteria:
inclusion criteria: * male or female voluntary patients between the ages of 18 and 59 with fitzpatrick skin type iv-vi as verified by one of the investigators * patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring * patients able to follow instructions * if patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex * written informed consent from the patients (appendix ii) exclusion criteria: * children (less than 18 years old) * pregnant or lactating women * personal history of keloids or hypertrophic scarring * active acne requiring topical or oral therapy * accutane or other oral retinoid in past year * patients with a known allergy to lidocaine * allergy to valacyclovir in a patient that needs prophylaxis * patients with an unstable or non controlled underlying medical problem * patients who are not able to follow instructions * patients who have participated in a study within the 3 months prior to study entry * patients who refuse to give written informed consent * patients with a history of a pigmentary abnormality

Keywords: acne scarring post inflammatory hyperpigmentation
carbon ion radiotherapy for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: treatment options for patients with advanced hepatocellular carcinoma (hcc) are often limited. in most cases, they are not amenable to local therapies including surgery or radiofrequency ablation. the multi-kinase inhibitor sorafenib has shown to increase overall survival in this patient group for about 3 months. radiation therapy is a treatment alternative, however, high local doses are required for long-term local control. however, due to the relatively low radiation tolerance of liver normal tissue, even using stereotactic techniques, delivery of sufficient doses for successful local tumor control has not be achieved to date. carbon ions offer physical and biological characteristics. due to their inverted dose profile and the high local dose deposition within the bragg peak precise dose application and sparing of normal tissue is possible. moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (rbe), which can be calculated between 2 and 3 depending on the hcc cell line as well as the endpoint analyzed. japanese data on the evaluation of carbon ion radiation therapy showed promising results for patients with hcc. in the current phase i-prometheus-01-study, carbon ion radiotherapy will be evaluated for patients with advanced hcc. the study will be performed as a dose-escalation study evaluating the optimal carbon ion dose with respect to toxicity and tumor control. primary endpoint is toxicity, secondary endpoint is progression-free survival and response.


Eligibility criteria:
inclusion criteria: * histologically confirmed hcc or diagnosis of hcc according to aasld-guidelines * macroscopic tumor * liver-confined disease without extrahepatic disease as diagnosed by ct, mrt, ultrasound and bone scan * minimal distance of tumor edge to the intestines of 1cm * age ≥ 18 years of age * karnofsky performance score ³60 * for women with childbearing potential, (and men) adequate contraception. * ability of subject to understand character and individual consequences of the clinical trial * written informed consent (must be available before enrolment in the trial) exclusion criteria: * refusal of the patients to take part in the study * previous radiotherapy of the hepatobiliary system * margin of \< 1cm between tumor edge and intestines * patients who have not yet recovered from acute toxicities of prior therapies * known carcinoma \< 2 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy * pregnant or lactating women * participation in another clinical study or observation period of competing trials, respectively

Keywords: hcc
overcoming learned non-use in chronic aphasia

Conditions: Stroke-induced Aphasia

Summary: in this study the investigators are examining the effectiveness of intensive speech therapy in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses "constrained" or unconstrained to speech. both treatments involve massed practice communicating, using intensive language action therapy 3 hours/day, 5 days/week for two weeks, followed by six months of a home practice program. one treatment stresses spoken responses as the preferred expressive modality during intensive therapy. before and after treatment, and following the home practice program and a period of no practice, the investigators will administer several tests and discourse samples to examine changes associated with the treatments. participants will also undergo structural and functional mri testing at these time points. the investigators will also attempt to quantify the degree to which improvements following intensive language therapy and home practice correlate with changes in quality of life measures as perceived by both participants with aphasia and their significant others. it is hypothesized that, whereas both treatments will lead to improvements in naming practiced words and communicating, outcomes will be enhanced for the group randomly assigned to the "constraint" condition. moreover, performance will be enhanced on words practiced during the home practice program, including those that were not practiced during intensive therapy. improved naming will correlate with modulation of 'signature' language and attentional networks, whose variability will depend on remaining viable brain structures. initial severity and site/extent of lesion should predict patients' ability to transfer gains in naming to improvements in discourse.


Eligibility criteria:
inclusion criteria: * unilateral left hemisphere stroke at least 6 months earlier * aphasia with moderate-to-severe word retrieval impairments * at least 21 years of age * premorbidly right handed * native speaker of english exclusion criteria: * history of developmental learning difficulties * history of prior neurological illnesses * chronic medical illnesses that restrict participation in intensive therapy * recent alcohol or drug dependence * severe uncorrected impairments of vision or hearing * any contraindication to a 3t mri procedure (e.g., claustrophobia, metal implants or fragments in body, pregnancy)

Keywords: aphasia anomia speech therapy rehabilitation neuroplasticity fmri quality of life
safety, tolerability, and efficacy of monotherapy and combination regimens in participants with nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis

Summary: the primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (nash).


Eligibility criteria:
key inclusion criteria: * historical liver biopsy consistent with nash with stage 2-3 fibrosis according to nash clinical research network (crn) classification or clinical diagnosis of nonalcoholic fatty liver disease and screening fibrotest, magnetic resonance imaging - proton density fat fraction (mri-pdff), and fibroscan * screening laboratory parameters, as determined by central laboratory: * alanine aminotransferase (alt) ≤ 5 x upper limit of the normal range (uln) * estimated glomerular filtration rate (egfr) ≥ 30 milliliter/minute (ml/min), as calculated by the modification of diet in renal disease (mdrd) study equation * hba1c ≤ 9.5% * international normalized ratio (inr) ≤ 1.2, unless due to therapeutic anti-coagulation therapy * platelet count ≥ 100,000/μl * total bilirubin \< 1.3 x uln unless alternate etiology such as gilbert's syndrome present * calcitonin ≤ 100 ng/l * body mass index (bmi) \> 23 kg/m\^2 and body weight of \> 60 kg key exclusion criteria: * any historical liver biopsy consistent with cirrhosis * any history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding * other causes of liver disease, including but not limited to: alcoholic liver disease, hepatitis b, hepatitis c, autoimmune disorders (eg, primary biliary cholangitis (pbc), primary sclerosing cholangitis (psc), autoimmune hepatitis), drug-induced hepatotoxicity, wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment * history of liver transplantation * history of hepatocellular carcinoma * history of pancreatitis (acute or chronic) * personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * treatment with glucagon-like peptide-1 receptor agonists (glp-1 ra) in the period from 90 days prior to the date of the screening visit * individuals on antidiabetic medications must be on a stable dose for at least 90 days prior to the date of the screening visit and in the period between the date of the screening visit and enrollment (day -14) note: other protocol defined inclusion/exclusion criteria may apply.
efficacy of systane balance to stabilize the tear film in dry eye subjects

Conditions: Dry Eye

Summary: evaluation of the optical effects of systane ultra


Eligibility criteria:
inclusion criteria: 1. age 18 years or more. 2. subjects must have tear break up time (tbut) \< 5 seconds 3. subjects must have a maximum blink interval (mbi) \< 10 seconds 4. subjects must be willing to comply with all study requirements. 5. subjects must understand, sign and be given a copy of the written informed consent form. exclusion criteria: 1. subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria 2. subjects who are pregnant, lactating or planning to be pregnant during the course of the study 3. subjects with known sensitivity to planned study concomitant medications 4. subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation. 5. use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Keywords: dry eye tear film stability
hemolysis in patients with hereditary spherocytosis (hs)

Conditions: Hereditary; Hemolysis

Summary: in the present study the investigators are going to explore the oxidative status of hs-rbc and its contribution to hemolysis

the oxidative status of cells, which is determined by the balance between pro-oxidants, such as the reactive oxygen species (ros), and antioxidants, is a major regulator of cellular functions. impaired balance between pro- and antioxidants causes oxidative stress which may result in oxidation of proteins, lipids and dna with the final outcome of premature cell aging and apoptosis \[1,2\]. oxidatively stressed red blood cell (rbc) have been observed in various congenital and acquired hemolytic anemias, including thalassemia, sickle cell anemia, congenital dyserythropoietic anemia, g6pd deficiency and paroxysmal nocturnal hemoglobinuria (pnh) as well as in myelodysplastic syndrome (mds). although the primary etiology is different in these anemias, oxidative stress mediates several of their pathologies, mainly hemolysis \[3\]. hereditary spherocytosis (hs) is a genetic disorder of the rbc skeleton with primary deficiency in spectrin, ankyrin-1, band 3 or protein 4.2 associated with chronic hemolytic anemia \[4\]. secondary protein deficiencies resulting from oxidative stress are often observed and may be involved in the clinical manifestations of the disease \[5\].

Eligibility criteria:
inclusion criteria: * patients \> 5 years * with documented family history of hs * patients should have clinical and laboratory findings, consistent with mild to severe hs, diagnosed on the basis of spherocyte morphology, elevated mchc (33-38 g/dl), with a mean value of (35.47 g/dl), increased osmotic fragility , splenomegaly and non-immune mediated hemolysis. exclusion criteria: * non

Keywords: hemolysis in patients with hereditary spherocytosis with documented family history of hs. spherocyte morphology, splenomegaly and non-immune mediated hemolysis.
efficacy, tolerability and pharmacokinetics of subcutaneous exendin (9-39) in patients with post bariatric hypoglycemia

Conditions: Post Bariatric Hypoglycemia

Summary: this study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous exendin (9-39) in subjects with post-bariatric hypoglycemia. development of this subcutaneous formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare disease with unmet clinical need.

post-bariatric hypoglycemia (pbh) is a rare, but increasingly reported disease occurring after bariatric surgery, characterized by severe hypoglycemic episodes accompanied by symptoms of hypoglycemia. at the moment, no medical therapies have been developed for this disorder, but the clinical need is great. the major contributory factor is thought to be an exaggerated secretion of glucagon-like peptide-1 (glp-1) due to altered nutrient transit after bariatric surgery. glp-1 is an incretin hormone secreted primarily by the distal ileum that contributes to postprandial glucose regulation. exendin (9-39) is a specific glp-1 receptor antagonist, that when given via continuous iv infusion, has been shown to effectively prevent postprandial hypoglycemia and reduce symptoms of hypoglycemia in patients with pbh. this study is designed to assess the efficacy, safety and pharmacokinetic profile of a novel subcutaneous formulation of exendin (9-39).

Eligibility criteria:
inclusion criteria: * post-bariatric surgery more than 6 months prior to signing the informed consent * reported history of whipple's triad: the occurrence of hypoglycemic symptoms associated with a capillary blood glucose of ≤55 mg/dl, and resolution with glucose or carbohydrate administration. * symptomatic hypoglycemia during the baseline/screening oral glucose tolerance test (ogtt), as defined by the presence of plasma glucose ≤55 mg/dl with concomitant autonomic and/or neuroglycopenic symptoms. exclusion criteria: * patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug. * participation in any clinical investigation within 4 weeks prior to dosing * history of or current insulinoma * active infection or significant acute illness within 2 weeks prior to dosing * female patients who are pregnant or lactating * women of childbearing potential and not utilizing effective contraceptive methods * inadequate end organ function

Keywords: bariatric surgery complications glucose metabolism disorders exendin (9-39) glp-1
resuscitation with plasma in surgical and trauma patients with septic shock

Conditions: Septic Shock

Summary: there is a knowledge gap regarding the optimal initial fluid to achieve effective resuscitation and improved outcomes in septic shock. the purpose of this study is to compare initial resuscitation with plasma to initial resuscitation with balanced crystalloids.


Eligibility criteria:
inclusion criteria: * patients meeting the following criteria will be enrolled: have a sepsis screening score (sss) ≥ 4 with a suspected source of infection (table 1); and written informed consent obtained * patients meeting any of the following criteria will be randomized: hypotension with map \ 4 mmol/l; altered mental status; and decreased urine output of \< 0.5 ml/kg in the past hour. exclusion criteria: * pregnancy * prisoners * traumatic brain injury * evidence of ongoing hemorrhage, history of congenital bleeding disorders, therapeutic anticoagulation * history of myocardial infarction or congestive heart failure * history of acute cerebral vascular event * major burns (\>20% total body surface area) * history of adverse reactions to blood product transfusion * contraindications to blood transfusions (eg. jehovah's witness) * contraindications to central venous line and arterial line placement * on intermittent hemodialysis * do-not-resuscitate or comfort care status * participation in another interventional study * pending transfer to another unit within the hospital that is not sticu or simu
arachidonic acid supplementation in very preterm infants

Conditions: Impaired Psychomotor Development

Summary: long-chain polyunsaturated fatty acids (lcpufas), arachidonic acid (aa omega-6; 20:4ω-6), and docosahexaenoic acid (dha omega-3; 22:6ω-3), are required for the formation of non-myelinated cell membranes in the central nervous system, including in the retina, hence the great importance of them for appropriate visual and cognitive development. in this study, the investigators assessed anthropometric, visual, auditory, and psychomotor development in very preterm infants who had diets supplemented with different lcpufa amount of aa to support the importance of sufficient aa values in formula.

the investigators carried out a prospective randomized controlled double blinded trial in order to study nutritional supplements for preterm infants \<1500 grams and/or \<32 weeks gestational age (ga) who were born in clinical university hospital of santiago de compostela (chus). they were enrolled for a period of 14 months (from july 2011 to august 2012) and followed up from birth until 2 years of age. milk formulas were provided either as adjunct to insufficient amount of breast milk, or as full formula feeding. breastfeeding was actively encouraged. patients were randomized into one of the two formula groups, depending on the type of formula they were to receive. group a's formula was supplemented with dha (0.3% of all fatty acids) and aa (0.6%) with an ω-6/ω-3 ratio of 2/1. group b's formula was supplemented with dha (0.3%) and aa (0.3%) with an ω-6/ω-3 ratio of 1/1. primary outcome: assessment of psychomotor development with the brunet lézine scale at 2 years of age (early care unit chus) secondary outcomes: physical examination and anthropometric measurements (weight, length, and head circumference) at birth and at 3, 6, 9, 12, 18, and 24 months of age (neonatology unit chus) blood levels of fatty acids in the first week of life and at 3 months, 6 months, and 12 months. (metabolic unit. hospital de cruces, bilbao) visual- and auditory-evoked potentials at 6 and 12 months of age (neurophysiology unit chus)

Eligibility criteria:
inclusion criteria: * living infants who were less than 1500 grams and/or less than 32 weeks gestational age, and whose parents accepted and subscribed the informed consent exclusion criteria: * preterm infants with any severe malformation. * extremely preterm infants with a gestational age of less than 25 weeks. * infants whose parents could not complete the follow-up process in our study center. * preterm infants with severe intraventricular hemorrhage or periventricular leukomalacia (more than grade 2). * neonates who did not need supplementary milk nutrition, i.e. breastfed-only children.

Keywords: arachidonic acid omega-6/omega-3 ratio preterm infants nutrition
study of the tolerability and pharmacokinetics of oral doses of sar442168 with a food effect investigation in healthy adult participants

Conditions: Multiple Sclerosis

Summary: this is a randomized, placebo-controlled, four-part, phase i, first in human (fih) study to assess the tolerability and pharmacokinetics (pk) of ascending single and 14-day repeated oral doses of sar442168 with a food effect investigation in healthy adult participants. * in part 1a: the tolerability and safety of sar442168 and the pharmacokinetic parameters of sar442168 and metabolite(s)after ascending single oral doses in fasted and fed conditions * in part 1b: the relationship of pk of sar442168 and metabolite(s) in cerebrospinal fluid (csf) to that in plasma after single oral doses given in fed conditions (moderate-fat meal) * in part 1c: the effect of a high-fat meal on the pharmacokinetics of sar442168 and metabolite(s) (high-fat) * in part 1d: the effect of a high-fat meal on the pharmacokinetics of sar442168 and metabolite(s) (standardized high-fat meal) * in part 2: the tolerability and safety of sar442168 and the pharmacokinetic parameters of sar442168 and metabolite(s) after 14-day ascending repeated oral doses of sar442168 given in fed conditions (moderate-fat meal).


Eligibility criteria:
inclusion criteria: * having given written informed consent prior to undertaking any study-related procedure. exclusion criteria: * any subject who, in the judgment of the investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
share study 4: financial incentives for weight loss

Conditions: Obesity

Summary: the purpose of this study is to examine different types of monetary incentive paradigms for weight loss.


Eligibility criteria:
inclusion criteria: * bmi \>=25kg/m2 * english speaking * age 18-70 exclusion criteria: * health problems that make weight loss or unsupervised exercise unsafe * current pregnancy or plan to become pregnant int he next 12 months * planned relocation * current participation in weight loss research study
a preoperative cognitive behavioural therapy program based on self-determination theory for bariatric surgery candidates

Conditions: Bariatric Surgery Candidate; Obesity

Summary: the objective of this study is to evaluate the impact of a pre-surgical intervention program based on cognitive and behavioural emotional therapies, on the degree of dietary restriction of patients who are candidates for bariatric surgery in order to increase the long-term effectiveness of this kind of surgery


Eligibility criteria:
inclusion criteria: * patient starting a preparation for bariatric surgery in the endocrinology department at st philibert hospital * 18 ≤age≤60 years * patient meeting the criteria of the high authority of health (has) for the agreement of a bariatric treatment * patient affiliated to the social security * patient giving informed consent exclusion criteria: * low level of comprehension of french * pregnant women * patient under guardianship or curatorship.

Keywords: bariatric surgery candidate cognitive and behavioural emotional therapies obesity