Kornimate/medical-research-clean huggingface dataset:
incb000928 administered as a monotherapy or in combination with ruxolitinib in participants with anemia due to myeloproliferative disorders

Conditions: Anemia; Post-essential Thrombocythemia Myelofibrosis; Post-polycythemia Vera Myelofibrosis

Summary: this phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, pk, pd, and efficacy of incb000928 administered as monotherapy or in combination with ruxolitinib in participants with mf who are transfusion-dependent or presenting with symptomatic anemia. this study will consist of 2 parts: dose escalation and expansion.


Eligibility criteria:
inclusion criteria: * participants with mf who are transfusion-dependent or present with symptomatic anemia, defined as follows: 1. anemia: an hgb value \< 10 g/dl demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements (note: rbc transfusion must be at least 2 weeks before the hgb measurement during screening). 2. transfusion-dependent: participant has received at least 4 units of rbc transfusions during the 28 days immediately preceding cycle 1 day 1 or has received an average of at least 4 units of rbc transfusions in the 8 weeks immediately preceding cycle 1 day 1, for an hgb level of \< 8.5 g/dl, in the absence of bleeding or treatment-induced anemia. in addition, the most recent transfusion episode must have occurred in the 28 days before cycle 1 day 1. * ecog performance status score of the following: 1. 0 or 1 for the dose-escalation stages. 2. 0, 1, or 2 for the dose-expansion stage. * life expectancy is greater than 6 months * agreement to avoid pregnancy or fathering children. * ineligible to receive or have not responded to available therapies for anemia such as esas. * for tga: * participants previously treated with jak inhibitors for at least 12 weeks. * participants with intermediate-2 or high dipss mf according to iwg-mrt criteria. * for tgb: * participants must have been on a therapeutic and stable regimen of ruxolitinib for at least 12 consecutive weeks immediately preceding the first dose of study treatment. * participants with intermediate-1, intermediate-2, or high dipss mf according to iwg-mrt criteria. * for tgc: * participants must be jak inhibitor treatment naive (no prior treatment with any jak inhibitor) and have an indication for initiation of ruxolitinib treatment. * participants with intermediate-1, intermediate-2, or high dipss mf according to iwg-mrt criteria. exclusion criteria: * undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation. * any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib for tgb only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. * laboratory values outside of protocol defined range at screening.

Keywords: anemia
evaluation of left ventricular function by speckle tracking echocardiography in patient hospitalised in intensive care unit for vaso-occlusive crisis

Conditions: Sickle Cell Disease

Summary: vaso-occlusive crisis in sickle cell disease might alter myocardial function through micro vascular obstruction. evaluation of strain alteration using speckle tracking echocardiography is a non invasive technique that may allow us to observe such myocardial dysfunction. no such study has yet been conducted in patient hospitalised in intensive care unit. our hypothesis is that strain alteration during vaso-occlusive crisis, if they do exist, can be correlated with other markers of myocardial injury such as troponin level or thoracic pain.


Eligibility criteria:
inclusion criteria: * hospitalisation in an intensive care unit for vaso-occlusive crisis exclusion criteria: * pregnancy * individuals under guardianship * unsufficient echogenicity * thoracic pain prohibiting echocardiography assessment

Keywords: icu intensive care units transthoracic echocardiography left ventricular function
surgical specification and efficacy evaluation of total laparoscopic left liver resection

Conditions: Laparoscopic Hepatectomy; Hepatocellular Carcinoma

Summary: recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. currently it is only carried out in a few large medical centers with slow development. the related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .this project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.


Eligibility criteria:
inclusion criteria: * child-pugh a-b * primary hepatocellular carcinoma of the left liver lobe * tumor size ≤5cm in diameter * kps≥60 exclusion criteria: * significant abnormal liver function * significant abnormal heart function * significant abnormal lung function * significant abnormal kidney function
laparoscopic colorectal resection in elderly

Conditions: Colorectal Cancer

Summary: this is a nested cohort study of oambp-01. patients over 70 years old were enrolled into the data-analysis. the purpose of this study was to examine the feasibility and safety of laparoscopic colorectal resection in elderly patients from a single center, and to explore if there are advantages in laparoscopic surgery.

surgical resection remains the primary treatment for crc. despite advancements in surgical techniques, treating elderly cancer patients remains challenging for surgeons. perioperative risk increases as elderly patients are susceptible to cardiovascular and respiratory diseases. in addition, it has been demonstrated that elderly individuals come with more locally advanced tumor and are more likely to have obstructive or disseminated disease at the time of presentation. in addition, aging diminishes a person's physiological capacity to withstand a major operation. therefore, surgeons preferred to choose laparotomic colorectal resection to reduce surgical duration and morbidity.. the benefits of laparoscopic colorectal resections over laparotomic surgery have been clearly demonstrated in the general population. however, previous clinical trials comparing surgical approach between laparoscopy and laparotomy restricted the patient's age \<75 years, we have limited information on short- and long-term safety and efficacy of elderly patients underwent laparoscopic colorectal resection. the purpose of this study was to examine the feasibility and safety of laparoscopic colorectal resection in elderly patients from a single center, and to explore if there are advantages in laparoscopic surgery. this is a nested cohort study of oambp-01. patients over 70 years old were enrolled into the data-analysis.

Eligibility criteria:
inclusion criteria: * 1. patient underwent elective laparoscopic or laparotomic colorectal resection for cancer treatment; 2. patient baseline characteristics and surgical information were available; 3. patients with complete follow-up data. exclusion criteria: * 1. emergency surgery for causes including bowel obstruction, bleeding, or perforation; 2. multiple primary malignancies; 3. failure to follow-up.

Keywords: laparoscopy laparotomy elderly
frailty prevention in elders from reunion island

Conditions: Geriatric Assessment; Frail Elderly Syndrome; Prevention; Fall Patients

Summary: in reunion island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty. the study evaluates tools, supported by the latest scientific advances in "machine learning" to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions.

the 5p research program is a 6-years program that started in 2016. its objective is to set up tools, supported by the latest scientific advances in "machine learning" to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions. the diversity and transversal nature of the research disciplines in this program make it original. this allows it, through common protocols, to explore the concept of frailty and the care pathway of the elderly through different prisms of complementary observations. this program is deployed in three stages: proof of principle, proof of concept (called 5p-pilot) and "the scaling up" (called 5p-echelle). it combines an evaluation of the acceptability of technological detection tools, a measurement of the impact of prevention workshops on the loss of autonomy among independent frail elderly people and an evaluation of tools to help detect frailty. the ageing of the population poses a real societal challenge. the loss of autonomy, which is the result of multiple individual or environmental factors for the ageing person, has a costly impact in terms of recourse to care and on the people around them. it is therefore urgent to act on the levers of frailty by acting as early as possible to prevent its irreversibility. the "5p echelle" project aims to develop a semi-automatic and non-medical method for detecting weak signals of frailty in older people, by combining standardized clinical indicators for assessing their state of robustness with large-scale intelligent detection devices that allow for longitudinal monitoring, while integrating the necessary participatory dimension of the subject.

Eligibility criteria:
inclusion criteria: * persons over 65 years of age * retired persons * person affiliated to or benefiting from a social security scheme. * free and informed consent given exclusion criteria: * persons referred to in articles l1121-5 to l1121-8 of the french public health code (corresponding to all protected persons), pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure * difficulty in understanding the french language
phase i study of sorafinib with folfox4 as first-line treatment in advanced/metastatic gastric cancer

Conditions: Gastric Cancer.

Summary: * to determine the maximum-tolerated dose (mtd) and dose-limiting toxicity (dlt) of sorafenib in combination with folfox4 (oxaliplatin/leucovorin/5-fluorouracil) as first-line treatment for advanced gastric cancer * the design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the sorafenib dosage to the next level

-twice-daily dosing of sorafenib 200 mg in combination with folfox4 proved effective and safe for the treatment of advanced gastric cancer.

Eligibility criteria:
inclusion criteria: * age \>18 years. * documented gastric adenocarcinoma via histological or cytological examinations; * newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer; * no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; - * an eastern cooperative oncology group (ecog) performance status score of 0 or 1; * an expected survival time of at least 3 months; * and provision of informed consent by patients prior to commencement of the study. exclusion criteria: * a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix; * surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction; * severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy * a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation; * women of childbearing potential unwilling to use adequate contraception; a past medical history of heart disease such as greater than grade 2 new york heart association (nyha) congestive heart failure, unstable coronary heart disease (patients having episodes of myocardial infarction earlier than 12 months prior to the study were allowed to enrol), arrhythmia requiring antiarrhythmic therapy (patients on β-blockers or digoxin were allowed to enrol), or uncontrolled hypertension; severe active infection * epileptic patients requiring medical treatment (such as corticosteroids or antiepileptic drugs); * patients who had received immunotherapy within 4 weeks prior to or throughout the study or had received mitomycin c or nitrourea drugs within 4 weeks previously; * allergies or possible allergies to the study medications or other drugs administered during the study; * any patient safety or compliance issues that might jeopardize their participation in the study; * an inability to swallow oral drugs.

Keywords: sorafenib, gastric cancer, folfox4
pinhole versus tunnel for soft tissue recession

Conditions: Gingival Recession

Summary: this is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (pst) and tunnel technique.

each patient will undergo both surgeries on either quadrant; the pst and tunnel technique. the site will be randomized to receive either type of surgeries. both types of surgeries are considered minimally invasive procedures to obtain root coverage for gingival recession. both surgeries are clinically utilized in clinical practice and yield comparable results according to the literature, however, no prospective studies are published to compare between the outcomes of both techniques. patients will receive intra oral scan before the surgery and 6 months after the surgery to compare change in root coverage and gingival thickness outcomes between the two techniques. post operative pain as well as patient satisfaction will be measured by visual analog scale and compared between the two techniques. patients will be monitored at different time points to asses healing.

Eligibility criteria:
inclusion criteria: * between 18-75 years old * have at least one non-mobile tooth with cairo class i gingival recession of 2 to 6 mm. * american society of anesthesiology class i and ii * full mouth plaque score (fmps) and full mouth bleeding score (fmbs) below 20% exclusion criteria: * sites of gingival recession around teeth that are non-salvageable * presence of any exudate, infection or local inflammation around the area to be grafted * pregnant or breastfeeding females
computer-based cognitive training and sleep quality in older adult insomniacs

Conditions: Insomnia

Summary: the purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.

participants in the cognitive training group train in a computer-based cognitive training program over a period of 12 weeks. an active control group train in a program involving tasks that do not engage high-level cognitive functioning over the same period.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic insomnia * able to use a home personal computer * have healthy dominant hand functioning * hebrew speakers exclusion criteria: * have any significant visual or hearing impairment * have any significant medical, neurological or psychiatric illness that might bring about cognitive change * have sleep disorders other than insomnia * have any significant medical disease (including cancer, diabetes, liver, kidney, heart or lung disease) * alcoholism or other drug abuse * taking any medication known to affect central nervous system functioning other than sleeping pills * historical evidence suggesting significant psychiatric conditions such as depression, psychosis or neurologic disease

Keywords: cognitive training insomnia
the effects of hmo on the faecal microbiota and on gastrointestinal symptoms in healthy volunteers

Conditions: Gut Microbiota; Gastrointestinal Symptoms

Summary: the study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study with healthy volunteers. a total of 100 male and female volunteers will be included. the volunteers will be randomized into one of 10 groups, each of 10 participants, consuming either active product in various mixes and doses (9 groups) or placebo product (1 group) for 2 weeks. the 9 groups receiving active product will receive either one of two human milk oligosaccharides (hmos) alone or in combination at different doses. the primary purpose of the study is establishing the effects of various compositions and doses of hmos on the faecal flora and on gastrointestinal symptoms in health adults.


Eligibility criteria:
inclusion criteria: * signed written informed consent * ability and willingness to understand and comply to the study procedures exclusion criteria: * participation in a clinical study one month prior to screening visit and throughout the study. * abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator. * any gastrointestinal symptom scored \>3 on the gsrs during the screening period * a mean score on the total gsrs \>2 (i.e. above the population norm value) during the screening period * any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator. * other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator. * severe psychiatric disease, as judged by the investigator. * use of highly dosed probiotic supplements (yoghurt allowed) 3 months prior to the study and throughout the study. * consumption of antibiotic drugs 3 months prior to screening and throughout the study. * consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) 2 weeks prior to screening and throughout the study. * pregnant or lactating or wish to become pregnant during the period of the study. * lack of suitability for participation in the study for any reason as judged by the investigator.

Keywords: human milk oligosaccharides microbiota prebiotics
study of the human anti-tnf monoclonal antibody adalimumab for the induction of clinical remission in subjects with crohn's disease

Conditions: Crohn's Disease

Summary: the goal of this study is to test whether adalimumab can induce clinical remission in subjects with active crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.


Eligibility criteria:
inclusion criteria: * males and females between the ages of 18 and 75 who are diagnosed with mild to moderate crohn's disease (defined by a cdai \[crohn's disease activity index\] score of 220 and 450) * normal lab parameters * are willing to give informed consent * have previously used and either were intolerant to or lost response to infliximab exclusion criteria: * history of certain types of cancer * diagnosis of ulcerative colitis * pregnant female or breast feeding subjects * known obstructive strictures * surgical bowel resection in the past 6 months * history of listeria, human immunodeficiency virus (hiv), central nervous system demyelinating disease or untreated tb (tuberculosis) * history of poorly controlled medical conditions * specific doses and durations of crohn's medications * subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab
the presence of sarcopenia in patients with knee osteoarthritis

Conditions: Sarcopenia; Osteoarthritis

Summary: osteoarthritis (oa) is one of the most common joint disorders worldwide . the knee is the most common symptomatic joint in osteoarthritis. in this study, we evaluated the presence of sarcopenia multidimensionally in patients with knee osteoarthritis (oa) using clinical, ultrasonographic and biochemical parameters, and in this respect, it was aimed to investigate the relation between oa and sarcopenia and to identify the most practical, easily accessible and inexpensive method for investigating sarcopenia.

102 patients with clinical and radiological diagnosis of knee osteoarthritis and 33 healthy control subjects were included in the study. a total of 135 subjects were evaluated using the european working group on sarcopenia in older people (ewgsop) diagnostic criteria of sarcopenia. the first group consists of (oa) patients with sarcopenia, the second group consist of oa patients without sarcopenia and the third group is controls subjects. the detailed musculoskeletal system examination of the patients included in the study was carried out by a single physician, and complete blood count, renal function tests, electrolytes, total protein, albumin, 25 (oh) vitamin d, serum leptin, serum adiponectin, pth, tsh and vitamin b12 values were recorded using the venous blood samples taken from the study group.dual-x-ray absorptiometry (dexa) is used to measure body composition parameters and muscle mass measurements, isometric muscle strength evaluations, handgrip strength and gait speeds for diagnosis of sarcopenia. short-form -36 (sf-36) the nutritional assessment-short form (mna), the western ontario and mcmaster universities osteoarthritis index (womac), the international physical assessment questionnaire short form (ipaq-sf) and the center for epidemiologic studies depression scale (ces-d scale) were administered to every patient as outcome measures.

Eligibility criteria:
inclusion criteria: * patients between the ages of 50-70 * patients who have been followed up with the diagnosis of knee ostheoarthritis * patients who have been followed up with the diagnosis of knee ostheoarthritis and sarcopenia exclusion criteria: * previous history of any trauma/surgical history of the lower extremities (other than amputation) * rheumatic diseases contracture of the knee and the ankle of the intact limb * malignant disease * hyperthyroidism/ hypothyroidism * chronic inflammatory disease * diabetes mellitus, and uncontrollable heart and kidney diseases * pregnant women

Keywords: dual-x-ray absorptiometry sarcopenia knee osteoarthritis ultrasonography