Kornimate/medical-research-clean huggingface dataset:
open-label phase iii long-term safety trial of liprotamase

Conditions: Cystic Fibrosis; Exocrine Pancreatic Insufficiency

Summary: this is an open-label, single-arm clinical study investigating the long-term safety of altu-135 treatment in patients with cystic fibrosis (cf)-related exocrine pancreatic insufficiency (pi).


Eligibility criteria:
inclusion criteria * females of childbearing potential must be willing to use birth control * diagnosis of cf based upon the following criteria: * two clinical features consistent with cf; and either * a genotype with two identifiable mutations consistent with cf, or * sweat chloride \> 60 milliequivalents per liter (meq/l) by quantitative pilocarpine iontophoresis. * clinically stable with no evidence of acute upper or lower respiratory tract infection * exocrine pancreatic insufficiency (pi) determined by fecal elastase \< 100 micrograms per gram (µg/g) measured at screening * able to take pancreatic enzyme supplementation in the form of capsules * able to perform the testing and procedures required for this study, as judged by the investigator exclusion criteria: * age \<7 years * pregnancy, breastfeeding or of childbearing potential and not willing to use birth control * participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening * history of fibrosing colonopathy * history of liver transplant, lung transplant or significant surgical resection of the bowel * any chronic diarrheal illness unrelated to pi * abnormal liver function (except for patients with gilbert syndrome) * signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to cf * unable to discontinue enteral tube feedings during the study * any condition that the investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient * baseline coefficient of fat absorption (cfa) ≥ 93% from the phase iii efficacy study * patient is unlikely to complete the study, as determined by the investigator

Keywords: cystic fibrosis-related exocrine pancreatic insufficiency
3d imaging assessment of scoliosis: back height difference vs. trunk rotation angle

Conditions: Adolescent Idiopathic Scoliosis

Summary: this study focuses on adolescents with idiopathic scoliosis, employing 3d imaging technology with depth cameras to measure back height difference (bhd) and angle of trunk rotation (atr) before and after conventional treatments such as massage, exercise therapy, and bracing. statistical analyses are conducted to verify the correlation between bhd and atr and to assess the sensitivity of bhd in evaluating short-term treatment effectiveness.


Eligibility criteria:
inclusion criteria: (1) adolescents aged 10-18 years, diagnosed with adolescent idiopathic scoliosis (ais) with a cobb angle ≥10°; (2) no history of spinal surgery or other corrective treatments; (3) able to undergo short-term inpatient treatment (5 days) and comply with study procedures. exclusion criteria: (1) patients with congenital, neuromuscular, or other secondary scoliosis; (2) presence of major comorbidities affecting spinal structure or muscle tone (e.g., spinal cord injury, muscular dystrophy); (3) patients unable to complete standardized assessment procedures.
chronic alcohol, stress inflammatory response and relapse risk

Conditions: Alcohol Dependence; Depressive Symptomatology

Summary: the purpose of this study is to examine potential stress and immune systems adaptations underlying craving and relapse vulnerability in alcohol dependent (ad) individuals and social drinkers (sds) with and without high levels of depressive symptomatology (+dep / - dep). using the investigators experimentally validated guided imagery procedure, the investigators propose to examine the response of brain stress and immune systems to personalized guided stressful imagery using subjective, physiological and neurobiological assessments in 60 healthy controls and 60 alcoholic dependent individuals with and without depressive symptomatology.


Eligibility criteria:
inclusion criteria: * ads: male and females, aged 18-50 years, meeting current dsm-iv criteria for alcohol dependence consuming more than 25 drinks / week. * sds: male and females, aged 18-50 years. must not meet either current or lifetime dsm-iv criteria for alcohol/drug abuse. they must have demonstrated weekly alcohol use over the past year but no more than 25 drinks / month with no occasion of binge drinking (5 or more drinks-men; 4 or more -women). * ads and sds must self-report depression ratings at levels to match one of the two following groups: a) a score of 20 or above in the center for epidemiologic studies - depression scale (ces-d), or b) a score between 3 -20 on the ces-d * weekly alcohol use as documented by positive urine toxicology screens (ad only). * good health as verified by screening examinations and medical and screening * able to read english and complete study evaluations. * all participants must voluntarily provide informed consent and sign the informed consent document. exclusion criteria: * meeting current criteria for dependence on another psychoactive substance, excluding nicotine. * having any current axis i psychiatric disorders and requiring treatment/medication for these conditions. * having significant underlying medical conditions requiring medication. * women who are pregnant or nursing.

Keywords: alcohol dependence stress cytokines depressive symptomatology
nsaids in coronary artery disease patients

Conditions: CAD

Summary: introduction: different groups already showed in retrospective subgroup analyses, that there is an increased risk for cardiovascular events in patients on a simultaneous asa/nsaid treatment. methods: light-transmission aggregometry hypothesis: simultaneous administration of different nsaids and asa impair the platelet inhibiting effect of asa.


Eligibility criteria:
inclusion criteria: * patients on a simultaneous asa, nsaid treatment * \> 18 years exclusion criteria: * unconsciousness, not able to consent * reanimation, cardiac shock
a dose escalation study to assess pk, safety and tolerability of inc280 when taken with food in cmet dysregulated advanced solid tumors.

Conditions: cMET Dysegulation Advanced Solid Tumors

Summary: dose escalation study to assess pk, safety and tolerability of inc280 when taken with food in patients with cmet dysregulated advanced solid tumors.


Eligibility criteria:
inclusion criteria: * cmet dysregulated advanced solid tumor * at least one measurable lesion as defined by recist 1.1 * recovered from all toxicities related to prior anti-cancer therapies to grade ≤ 1 * adequate organ function * ecog performance status (ps) ≤ 1 exclusion criteria: * prior treatment with crizotinib or any other cmet or hgf inhibitor * known hypersensitivity to any of the excipients of inc280 * symptomatic central nervous system (cns) metastases who are neurologically unstable * presence or history of a malignant disease other than the study related cancer * clinically significant, uncontrolled heart diseases * thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting inc280 or patients who have not recovered from radiotherapy-related toxicities * major surgery within 4 weeks prior to starting inc280 * impairment of gi function * patients receiving unstable or increasing doses of corticosteroids * patients receiving treatment with any enzyme-inducing anticonvulsant * pregnant or nursing (lactating) women other protocol-related inclusion/exclusion criteria may apply

Keywords: cmet, inc280, food,
external comparison of ibalizumab in trials vs. other regimens in opera

Conditions: HIV-1-infection

Summary: among heavily treatment experienced people living with hiv, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the opera cohort.

the us department of health and human services (dhhs) hiv treatment guideline suggest that ibalizumab may be considered in the context of multidrug resistance without fully active art options. however, clinical trials assessing ibalizumab efficacy did not include an active comparison arm in which participants did not receive ibalizumab. the use of external controls can provide valuable information and context to interpret the results of clinical trials when randomization to a control arm cannot be performed. the opera (observational pharmaco-epidemiology research \& analysis) cohort, a large us electronic health record database, is well suited for this as the opera and trials populations arose from the same geographic location (i.e., us). an external comparison of ibalizumab + optimized background regimen from trials vs. non-ibalizumab containing regimens in routine clinical care in the opera cohort may confirm results from prior studies suggesting viral control benefits of ibalizumab.

Eligibility criteria:
inclusion criteria (trial iba+obr group): * participant in tmb-202 or tmb-301/311 * received 800 mg iba every 2 weeks, with or without a loading dose inclusion criteria (opera non-iba obr group): * hiv-1 infection * 18 years or older * heavily treatment experienced (i.e., ever on a regimen containing either dtg bid or drv bid) * documented resistance to ≥1 arv from each of three arv classes * genotype information available for all the relevant gene regions (see table 2) * viral load \> 200 copies/ml at index regimen initiation * not pregnant at index * no new aids defining event within 3 months before/on index (except cutaneous kaposi's sarcoma or hivaw) * no new cancer diagnosis within 12 weeks before/on index * no iba prescribed prior to/with the index regimen * index regimen does not include cabotegravir, fostemsavir, investigational drugs * viral sensitivity/susceptibility to at least one arv in the index regimen * baseline vl available (within 6 months before/at index) * baseline cd4 available (within 6 months before/at index) * ≥1 vl measurement at any time after index

Keywords: heavily treatment experienced external comparison ibalizumab virologic effectiveness
biological collection of kidney cells

Conditions: Pseudoxanthoma Elasticum

Summary: our objective is to obtain human induced pluripotent stem cells from urine samples of pxe patients for further proteomic and metabolomic studies and treatment screening.

pseudoxanthoma elasticum (pxe) is a genetic multysystem disorder with cutaneous, ophtalmological and cardiovascular involvement. pxe is associated with mutations of abcc6 gene coding for the membrane transporter abcc6 protein. this transporter is normally expressed in hepatocytes and epithelial cells of renal proximal convoluted tubules. thus, pxe could be regarded as a metabolic disease of hepatic and renal origin, with clinical and biological involvement/consequences for remote organs. the substance transported by abcc6 protein being still unknown, ethiological pxe treatment does not exist yet. however, abcc6 deficiency is associated with low level of blood ppi (pyrophosphate), which is natural inhibitor of calcium-phosphate deposition. the aim of the project is to obtain the renal cells derived from pxe patients for their further usage in proteomic and metabolomic studies, as well as for screening of treatment modalities aimed to correct abcc6 functional deficiency.

Eligibility criteria:
inclusion criteria: * patient with pxe diagnosed on clinical and histological criteria, according to current guidelines * patient aged over 18 * patient informed, having understood the purpose and means of the study and signed the consent of participation * patient affiliated to the french social welfare system exclusion criteria: * pregnant or nursing pxe woman * patient under guardianship, deprived of liberty by court or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research

Keywords: pxe renal cells urine calcification omics drug screening
a study of onartuzumab (metmab) versus placebo in combination with paclitaxel plus platinum in patients with squamous non-small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (metmab) in combination with paclitaxel plus platinum in patients with incurable stage iiib or stage iv squamous non-small cell lung cancer (nsclc). patients will be randomized to receive either onartuzumab (metmab) 15 mg/kg iv or placebo on day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on day 1 of each 21-day cycle. patients who have not progressed after 4 cycles will continue with either onartuzumab (metmab) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically or cytologically confirmed stage iii b or stage iv squamous non-small cell lung cancer (nsclc) * eastern cooperative oncology group (ecog) performance status 0 or 1 * no prior chemotherapy for squamous nsclc * adequate tissue for central ihc assay of met receptor, and egfr testing if egfr status is unknown * radiographic evidence of disease exclusion criteria: * prior systemic treatment for stage iiib or iv squamous nsclc * nsclc with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or nsclc not otherwise specified (nos) * prior exposure to experimental treatment targeting either the hgf or met pathway * patients with tumors confirmed to have egfr-activating mutations who are suitable for anti-egfr therapy (e.g. gefitinib or erlotinib), as determined by the investigator * uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to day 1 of cycle 1 * history of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer * pregnant or lactating women * uncontrolled diabetes * impaired bone marrow, liver or renal function as defined by protocol * significant history of cardiovascular disease * positive for hiv infection
changes in amino acid absorption after adding a probiotic to an acute protein feeding

Conditions: Amino Acid Absorption; Probiotic

Summary: the purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic.

the study will be conducted using a randomized, double-blind, crossover study design. thirty healthy men and women between 18 - 35 years of age will be recruited to participate in this study. two supplementation protocols that each span three weeks will be completed and separated with a washout period of three weeks. participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a powder milk protein and placebo or a single daily 25-gram dose of a powder milk protein plus a single strain probiotic. upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. on the day of experimental testing, subjects will arrive to the laboratory in a fasted state. subjects will rest semi-supine for multiple blood sampling. following baseline sampling, participants will ingest their respective supplement plus a standard bolus of milk protein (powder form, mixed with 12 fl oz of cold water). thereafter, blood samples will be taken at 30, 60, 90, 120, 180, and 240 minutes post-ingestion. study participants will be provided an additional three-week supply of the alternative treatment to begin after observing a three-week washout. after three weeks of supplementation, study participants will return to the laboratory for their remaining testing visit.

Eligibility criteria:
inclusion criteria: * participants will be male or female between the ages of 18-35 years; * participants have not been consuming any nutritional supplements for the preceding 6-week period; * participants have not been consuming any ergogenic aids for the preceding 6-week period; * participant has provided written and dated informed consent to participate in the study; * participant is willing and able to comply with the protocol; * participant is apparently healthy and free from disease, as determined by a health history questionnaire; exclusion criteria: * participant is allergic to any ingredient in the nutritional supplement or placebo; * participant is not pregnant or trying to become pregnant, nor breast feeding; * participant reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study; * participant currently ingests nicotine or has quit within the last 6 months;
radiation therapy after surgery in treating women with phyllodes tumor of the breast

Conditions: Breast Cancer

Summary: purpose: this phase ii trial studied how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast. rationale: radiation therapy uses high-energy x-rays to damage tumor cells. radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.

objectives: * determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy. * determine the survival rate in patients treated with this regimen. methods: within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. patients were then followed every 6 months for 10 years.

Eligibility criteria:
disease characteristics: 1. histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following: 1. borderline, defined as 5-9 mitoses/10 high power fields (hpf), pushing or infiltrating margins, 2+ atypia 2. malignant, defined as 10 or more mitoses/10 hpf, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia 2. must have been excised with breast-conserving resection and no positive margins 3. local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision 4. no prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast 5. hormone receptor status: not specified patient characteristics: 1. age: 18 and over 2. sex: female 3. menopausal status: not specified 4. performance status: not specified 5. life expectancy: not specified 6. hematopoietic: not specified 7. hepatic: not specified 8. renal: not specified 9. other: 1. not pregnant 2. negative pregnancy test 3. fertile patients must use effective contraception prior concurrent therapy: 1. biologic therapy: not specified 2. chemotherapy: not specified 3. endocrine therapy: not specified 4. radiotherapy: no prior radiotherapy to the ipsilateral breast 5. surgery: see disease characteristics

Keywords: recurrent breast cancer phyllodes tumor
effects of benson relaxation exercise on anxiety level and sleep quality in adolescents

Conditions: Relaxation Program; Anxiety; Sleep Quality; Psychiatric Hospitalization

Summary: purpose: the purpose of this study is to examine the effects of benson relaxation exercise applied to children and adolescents receiving inpatient treatment in a psychiatric clinic on anxiety levels and sleep quality. design: the study is a randomized controlled trial with a pretest-posttest control group. method: the study will be conducted in a private psychiatric hospital in turkey between october 2024 and june 2025. when hospital records were examined, it was determined that 100 patients received inpatient treatment in the last year. therefore, the universe of the study consisted of 100 patients. the effect of some instructions in the benson relaxation exercise on delusions and hallucinations is unknown. therefore, psychosis and schizophrenia patients with delusions and hallucinations will be excluded from the scope of the study. patients who meet the inclusion criteria will be randomly assigned to the intervention and control groups. the study will be terminated when a total of 60 patients are reached, 30 in the intervention and 30 in the control group. benson relaxation exercise will be applied to the patients in the intervention group. no application will be made to the patients in the control group. research data will be collected with the "state-trait anxiety scale" and "pittsburgh sleep quality index". hypotheses: h1: the anxiety level of patients who applied benson relaxation exercise is lower than the patients who did not. h2: the sleep quality of patients who applied benson relaxation exercise is better than the patients who did not.


Eligibility criteria:
inclusion criteria: * being treated in the child and adolescent clinic at the hospital where the study was conducted * being between the ages of 14-18 * not diagnosed with psychotic disorder or schizophrenia * scoring between 20 and 59 on the stai i-ii scale * scoring 5 and above on the psqi scale * being willing to participate in the study * parents giving verbal consent for participation in the study and signing the written voluntary consent form exclusion criteria: * not receiving treatment in the child-adolescent clinic at the hospital where the study was conducted * not being between the ages of 14-18 * being diagnosed with psychotic disorder and schizophrenia * not receiving a score between 20-59 on the stai i-ii scale * receiving a score below 5 on the psqi scale * not being willing to participate in the study * the parent not giving verbal consent for participation in the study and not signing the written voluntary consent form