Kornimate/medical-research-clean huggingface dataset:
analysis and valuation of the expertise of use of the close friends of people victims of traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the close friends of people victims of traumatic brain injury.

collection of the expertise of use of the close friends of people victims of traumatic brain injury. the objective of the work is to collect, to describe, to analyze the corpus of knowledge of the close friends and to transcribe it in two registers, theoretical and practical..

Eligibility criteria:
inclusion criteria: * victim of a grave or moderate traumatic brain injury. * living at home or in institution * seen in consultation in the uh of angers in neurology and/or in the center of rehabilitation specialized the capuins and/or followed by arch anjou and/or sent by the associations of families. * 18 - 65 years at the time of the inclusion * moderate or grave traumatic brain injury, defined by the score of initial glasgow 13 and/or a hospitalization of at least 48 hours in intensive care. * existence of at least a referent close friend(relation) : parent(relative), child, spouse, professionnal or other. * obtaining of the informed consent of the cranial traumatized, the close friend and the guardian if necessary. exclusion criteria: * lack of consent to participate in the study

Keywords: traumatic brain injury
telaprevir, peg-ifn-alfa-2a, and rbv in treatment-experienced black/african american and non-black/african american subjects with genotype 1 chronic hepatitis c

Conditions: Hepatitis C

Summary: the purpose of this study is to evaluate the efficacy and safety of telaprevir in combination with pegylated interferon alfa 2a (peg-ifn-alfa-2a) and ribavirin (rbv) in treatment-experienced black/african american and non-black/african american participants with genotype 1 chronic hepatitis c (chc), who have not achieved a sustained viral response with a prior course of interferon-based therapy.

this is a single-arm, open-label, multicenter study of treatment-experienced participants with genotype 1 chc, who self-identified as black/african american (group a) or who did not self-identify as black/african american (group b). participants did not achieve a sustained virologic response 24 weeks after at least 1 prior course of peg-ifn-alfa-2a/rbv therapy of standard duration, and have 1 of the following viral responses: * prior relapse: participant had a documented undetectable hepatitis c virus ribonucleic acid (hcv rna) level at the planned end of treatment of at least 42 weeks duration (hcv rna evaluated anytime between 3 weeks before and 6 weeks after the last dose of peg ifn-alfa-2a or rbv). * prior null response: participant had a \<2-log10 decrease in hcv rna at 12 weeks, during prior peg ifn-alfa-2a/rbv treatment, but never achieved undetectable hcv rna while on treatment. * prior partial response: participant had a \>=2-log10 decrease in hcv rna at 12 weeks, during prior peg ifn-alfa-2a/rbv treatment, but never achieved undetectable hcv rna while on treatment.

Eligibility criteria:
inclusion criteria: * participants self-identify as black/african american (group a) or did not self-identify as black/african american (group b) * participants have genotype 1 chc and laboratory evidence of hepatitis c virus (hcv) infection for at least 6 months * participants did not achieve sustained viral response 24 weeks after last dose of study drug (svr24), after at least 1 prior course of peg-ifn-alfa-2a/rbv therapy of standard duration exclusion criteria: * participants have received previous treatment with telaprevir or any other protease inhibitor(s) for chc * participants who have evidence of hepatic decompensation * participants have diagnosed or suspected hepatocellular carcinoma * participants have any other cause of significant liver disease in addition to hcv * participants are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit * participants who participated in any investigational drug study within 90 days before dosing

Keywords: vx-950, incivek
regenecare® wound gel in treating rash in patients receiving cetuximab or other epidermal growth factor receptor inhibitor therapy for cancer

Conditions: Dermatologic Complications; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer. purpose: this clinical trial is studying how well regenecare® wound gel works in treating rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor therapy for cancer.

objectives: primary * determine the efficacy of regenecare® wound gel in alleviating pain and itching in patients who develop an acneiform rash while undergoing treatment with cetuximab or other egfr inhibitor therapy for cancer. secondary * determine the efficacy of this drug in reducing the severity of rash in these patients. * determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients. * determine the tolerability of this drug in these patients. outline: this is a prospective study. * observation: patients undergo evaluation by full-face photography prior to development of skin rash (baseline). while undergoing concurrent cancer therapy, patients self-monitor for the appearance of an acneiform rash. upon initial onset of rash, patients proceed to treatment. * treatment: patients apply topical regenecare® wound gel to the face ≥ 4 times daily. treatment continues for 4 weeks in the absence of unacceptable toxicity. patients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires.

Eligibility criteria:
disease characteristics: * diagnosis of cancer * starting treatment with cetuximab or other egfr inhibitor (e.g., erlotinib hydrochloride) on another clinical trial patient characteristics: * not pregnant or nursing * no known history of hypersensitivity to amine-type local anesthetics or to other components of mpm regenecare® wound gel * no other concurrent, serious skin disorders (i.e., scleroderma or psoriasis) that would interfere with assessment of egfr inhibitor-induced rash prior concurrent therapy: * see disease characteristics * no other concurrent topical facial creams or lotions

Keywords: dermatologic complications unspecified adult solid tumor, protocol specific
a study to compare efficacy and safety of ct-p17 with humira in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a phase iii study to compare efficacy and safety of ct-p17 with humira in patients with active rheumatoid arthritis

ct-p17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to humira. the purpose of this study is to demonstrate similar efficacy and safety of ct-p17 and humira in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Eligibility criteria:
inclusion criteria: * patient is male or female aged 18 to 75 years old, both inclusive. * patient has had a diagnosis of rheumatoid arthritis according to the 2010 american college of rheumatology(acr)/eular classification criteria for at least 24 weeks prior to the first administration of the study drug . exclusion criteria: * patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (tnf) α inhibitor for any purposes. * patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
evaluating the use of a silastic spring-loaded silo for infants with gastroschisis

Conditions: Gastroschisis

Summary: this study seeks to evaluate whether the routine, primary use of the spring-loaded silo (sls) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.

standard treatment of the infant with gastroschisis consists of , the bowel being reduced into the abdomen, when possible,and the abdominal wall defect being closed in the operating room. when complete reduction of the eviscerated contents is not possible, a silastic " silo" is sewn on the abdominal wall and its contents are gradually reduced into the abdomen over several days. once reduction is obtained, the silo is removed and the abdominal defect is closed. current methods of treatment are associated with significant morbidity, prolonged hospitalization, and high costs. gastroschisis closure continues to be accompanied by a number of complications ranging from ileus, sepsis, tpn-related liver damage, necrotizing enterocolitis, respiratory insufficiency, and death. the optimal timing and method of closure, including primary versus secondary closure, continues to be debated. no prospective randomized studies to date have examined the routine use of the spring-loaded silo.

Eligibility criteria:
inclusion criteria: * diagnosis of gastroschisis * birth weight ≥ 1500 grams * gestational age ≥ 34 weeks exclusion criteria: * birth weight \< 1500 grams * gestational age \< 34 weeks * presence of bowel ischemia or necrosis * abdominal wall defect too small * major associated anomalies or medical condition * presence of intracranial hemorrhage (grade iv) * parent refusal for randomization

Keywords: pediatrics gastroschisis silastic spring-loaded silo
conditional cash transfer intervention to improve t2dm

Conditions: Type 2 Diabetes

Summary: this study will test the preliminary efficacy of diabetes-tailored cct (dm-cct), which will be conditional on participating in biweekly (every two weeks), nurse-led, virtual diabetes education/skills training and stress/coping intervention compared to uct (with no requirement for participation) on clinical outcomes, self-care behaviors, and psychological health in 100 inner city aas with poorly controlled t2dm using an rct design. the aims of the proposed study include: aim 1: test the preliminary efficacy of the dm-cct intervention on glycemic control and quality of life for inner-city aas with t2dm. aim 2: test the preliminary efficacy of the dm-cct intervention on self-care behaviors and psychological health for inner-city aas with t2dm. aim 3: estimate the cost of delivery of the dm-cct and uct interventions in preparation for future cost effectiveness analysis.

the overarching aim of this proposal is to test the preliminary efficacy of diabetes-tailored cct (dm-cct conditional on participating in biweekly, nurse-led, virtual diabetes education/skills training and stress/coping intervention) compared to uct (with no requirement for participation) on clinical outcomes, self-care behaviors, and psychological health in inner city african americans with poorly controlled t2dm. one hundred (100) individuals will be randomized to either the dm-cct intervention or the uct intervention and followed for 6-months, with study visits at baseline, 3-months, and 6-months. the primary outcomes will be glycemic control (hba1c) and quality of life (sf-12) at 6-months post randomization. the secondary outcomes will be self-care behaviors (diet, exercise, medication adherence) and psychological health (stress, coping) measured at 6-months post randomization. in preparation for future cost effectiveness studies, the final aim will estimate the cost of delivery of the dm-cct and uct interventions.

Eligibility criteria:
inclusion criteria: * age ≥18 years * self-report as african american * clinical diagnosis of t2dm and hba1c ≥8% at the screening visit * residence in inner city zip codes * income greater or equal to133% of federal poverty level or medicaid eligible * able to communicate in english. exclusion criteria: * mental confusion on interview suggesting significant dementia * alcohol or drug abuse/dependency * active psychosis or acute mental disorder * participation in other diabetes clinical trials * life expectancy \<6 months
study evaluating safety, tolerability and efficacy of ym150 in subjects with acute coronary syndromes

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to evaluate the safety and efficacy of various doses of ym150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes.


Eligibility criteria:
inclusion criteria: * has a diagnosis of ste-acs, nste-acs as index event according to accepted guidelines such as the esc or aha guidelines * has elevated cardiac biomarkers exclusion criteria: * is planned for myocardial revascularization (e.g., coronary artery bypass graft (cabg) or elective or staged pci) or any other invasive procedure with increased risk for bleeding (i.e. elective surgical procedures) within 60 days after randomization * has had recent stroke or tia ≤ 12 months prior to index event * has persistent bp of 160 mmhg systolic or higher and/or 100 mmhg diastolic or higher at baseline with or without medication * has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study * has participated in any ym150 clinical trials * requires ongoing parenteral or oral anticoagulant therapy * has active bleeding or is in the opinion of the investigator at high risk of bleeding during the study

Keywords: factor xa anticoagulant ym150 acute coronary syndrome
the feasibility of a novel intervention for at risk mental state

Conditions: At Risk Mental State; Attenuated Psychotic Symptoms

Summary: young people with at risk mental state (arms) may have changes in their thoughts and the way they see or hear things, which they might find odd and distressing. they may be feeling tense, worried and low in mood and may not feel like socialising. they may also experience difficulties with eating and sleeping. for many people these symptoms might not last for very long, but for a small number of people, they might last longer and could become worse (health professionals call this psychosis). psychological therapy, which involves talking to a therapist, can help to stop these symptoms from getting worse, stopping psychosis. it can also help to make the symptoms better. cognitive behavioural therapy (cbt) is the treatment that is most recommended to help young people with arms. but, this is not always available, can take a long time and is quite expensive. some research has shown that brief therapy with a therapist who is warm and understanding and helps the young person to make sense of their symptoms, may be as helpful as cbt, and is quicker and cheaper. this study hopes to develop a treatment like this and to offer it to 12 young people, aged between 16 and 25, who are experiencing the symptoms outlined. participants will be given four treatment sessions, and will be asked to complete some questionnaires. the study aims to see how they find it and whether it seems to help them. it will also ask professionals who work with these young people what they think about the new therapy. this is a feasibility study so the findings will help us to decide whether more research should be done on this treatment and whether it could be offered in the nhs in the future.


Eligibility criteria:
for service user participants (those receiving the intervention) inclusion criteria: * 16 - 25 years old * meeting criteria for attenuated psychosis on the comprehensive assessment of at risk mental state (caarms; yung et al., 2005) * has an allocated lead care professional within the central norfolk youth team * identified by their care-coordinator as having capacity and being appropriate for therapy (including not being deemed at a high risk of being a danger to themselves or others). exclusion criteria: * meeting criteria for psychosis on the caarms and/or a previous open referral to an early intervention in psychosis team * change of psychiatric medication within the previous three months * currently receiving psychological therapy * previously had cognitive behavioural therapy for at risk mental state
piroxicam versus diclofenac for post caesarean section analgesia

Conditions: Analgesia; Post Caserean

Summary: multimodal analgesic combination of pentazocine-diclofenac has been found to be superior to pentazocine-piroxicam and was associated with a higher level of maternal satisfaction. our study aims to determine the efficacy of piroxicam when compared with diclofenac as pain relief post caesarean section.

abstract background: postoperative pain is unavoidable after caesarean section. it constitutes a big challenge to patient's recovery and maternal-infant bonding. the importance of adequate pain control cannot be over emphasized but there is no gold standard for post caesarean section analgesia. a multimodal approach to post caesarean section pain control has been shown to enhance analgesia and reduce side effects but the right combination of analgesics is yet to be determined. objective: to compare the efficacy of pentazocine and piroxicam versus pentazocine and diclofenac for post caesarean section analgesia within first 24 hours. method: eligible participants undergoingelective caesarean section atalex ekwueme federal university teaching hospital abakaliki (aefutha) and st patrick's mile 4 hospital abakaliki were randomized into two groups, a and b, of 54 participants each using computer generated list of random numbers. group a receiveda single dose of intramuscular piroxicam 20mg, while group b received two doses of intramuscular diclofenac 75mg given 12 hours apart. participants in both groups also received intramuscular pentazocine 30mg 6 hourly for 24 hours. the first dose of the drugs was administered immediately after skin closure. the primary outcome measure was control of postoperative painwithin the first 24 hours after caesarean section assessed using visual analogue scale, while the secondary outcome measures were the maternal drug side effects (epigastric pain, nausea etc) and participants' satisfaction. data obtained was entered into a predesigned sheet and analyzed using statistical package for social science (ibm spss) software (version 24, chicago ii, usa). a difference with a p-value \<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * pregnant women carrying live singleton fetusesat 37-42 weeks' gestational age. * consentingparturients who had elective caesarean section, under spinal anaesthesia. * american society of anaesthesiologists (asa) i-ii physical status. exclusion criteria * caesarean sections under general or epidural anesthesia * known allergy to pentazocine, diclofenacand or piroxicam * patients with uncontrolled hypertension/ pre-eclampsia or eclampsia * multiple gestation * history of peptic ulcer disease,asthma * patients with chronic pain or on long term opioids * women with dead fetuses or fetuses with congenital abnormalities * patients who are unable to rate the pain due to psychiatric illness or illiteracy. * parturients with severe obstetric haemorrhage, and sickle cell haemoglobinopathy * those that declined consent to participate in the study despite adequate counselling.

Keywords: pentazocine piroxicam diclofenac post caesarean analgesia
a pivotal study of apg-2575 (lisaftoclax) combined with azacitidine in the treatment of acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: a global, multicenter, randomized, double-blind, placebo-controlled, phase iii pivotal registration study, to evaluate the efficacy of apg-2575 (lisaftoclax) combined with azacitidine (aza) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.

the newly diagnosed acute myeloid leukemia, who are not eligible for standard induction chemotherapy, will be randomized to the investigational group (lisaftoclax+ aza) or the control group (placebo+ aza).

Eligibility criteria:
inclusion criteria: 1. patients must have newly diagnosed aml that meets the criteria for acute myeloid leukemia (aml) and be ineligible for standard chemotherapy. 2. life expectancy of ≥3 months. 3. be able to accept oral administration. 4. patients aged ≥70 years with ecog score of 0-2, or those aged≥18 years and \<70 years with ecog score of 0-3. 5. adequate kidney function. 6. white blood cell ≤ 30×10\^9/l. 7. adequate liver function. 8. men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective. 9. be able to understand and voluntarily sign written informed consent. 10. patients must be willing and able to complete study procedures and follow-up examinations. exclusion criteria: 1. the patient was diagnosed with acute promyelocytic leukemia or aml (bcr-abl1 positive. 2. active leukemic infiltration of the central nervous system. 3. active infection that requires systemic treatment. 4. use of a moderate or strong inducer and/or inhibitor of cyp3a4 within 7 days prior to first dose of the study drug. 5. previous treatment for hematologic disorders. 6. patients who has a cardiovascular disability status of new york heart association class \> 2. 7. patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption. 8. patients had a history of other malignancies prior to study initiation. 9. any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate the study.

Keywords: apg -2575 lisaftoclax