Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study of stsp-0601 in adult patients with hemophilia a or b with inhibitor

Conditions: Hemophilia

Summary: this study will assess the safety and efficacy of multiple-dose of stsp-0601 for the treatment of bleeding episodes in hemophilia a or b patients with inhibitors.


Eligibility criteria:
inclusion criteria: * 18 years old ≤age≤65 years of age,male. * hemophilia a or b patients with inhibitors. * received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (only for phase 2. minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe). * peak historical inhibitor titer ≥ 5 bu and a positive inhibitor test when enrolled. * establish proper venous access. * agree to use adequate contraception to avoid pregnancy. * provide signed informed consent. exclusion criteria: * have any coagulation disorder other than hemophilia a or b. * treat with prophylactic treatment of coagulation factor. * treat with anticoagulant within 7d of the time of study drug administration. * have a history of arterial and/or venous thromboembolic events. * have platelet \<100,000/ml,hemoglobin\<90g/l. * severe liver or kidney disease. * bleeding in the central nervous system or throat before screening. * accept major operation or blood transfusion within 1 month of the time of screening. * hiv positive with current cd4+ count of less than 200/μl. * have a known allergy to blood product. * participate in other clinical research within 1 month of the time of study drug administration. * treat with coagulant within 7d of the time of study drug administration.
a cognitive bias modification rct for aggression

Conditions: Intermittent Explosive Disorder

Summary: this randomized controlled trial will test a computerized cognitive bias modification program (cbm) to treat attention and interpretive biases in patients with primary aggression.

the objective of the proposed study is to test a computerized cognitive bias modification program (cbm) to treat attention and interpretive biases in patients with intermittent explosive disorder, a disorder characterized by habitual engagement in aggressive behavior. efficacy of the cbm program will be assessed via a small randomized controlled trial comparing cbm to a computerized control condition. this training program would consist of a four-week regimen of twice-weekly 30-minute sessions (8 sessions total) during which individuals would learn to: (a) focus attention away from threatening words toward neutral words \[attention bias\], and (b) to disambiguate ambiguous interpersonal scenarios using more benign, rather than threatening, interpretations \[interpretive bias\]. participants will be asked to complete behavioral measures of attention bias and interpretive bias, as well as self-report measures of anger / aggression, interpretive bias, emotion regulation and life satisfaction at baseline (pre-training), post-training, and 1-month follow-up.

Eligibility criteria:
inclusion criteria: * meet dsm-5 criteria for current ied, as assessed via phone screen and confirmed during an in-person diagnostic interview conducted during visit one of the study * are able and willing to cooperate with study protocol; i.e. keep appointments, read and understand consent form, etc. * have written and verbal english proficiency for understanding consent and study materials exclusion criteria: * have a lifetime history of psychosis * have current moderate to severe substance use disorder * have a history of bipolar disorder * have current major depressive disorder * are younger than 18 or older than 55 years old * are currently (past month) receiving treatment for anger or aggression * recently (past month) started or changed psychotropic medications
management of pain post hepatectomy : infiltration of local anesthetics versus continuous spinal analgesia .

Conditions: Pain, Postoperative

Summary: analgesia in liver surgery is a challenge, postoperative coagulopathy risk raises fears an epidural haematoma formation following the epidural analgesia, "gold standard" in major abdominal surgery. the spinal analgesia and/or continuous wound infiltration of local anesthetics constitute so an alternative. the study will compare the continuous infiltration of local anesthetics and rachianalgesia in terms of decreased postoperative morphine consumption and incidences of chronic postoperative pain at 3 and 6 months after hepatic surgery compared to the control group.


Eligibility criteria:
inclusion criteria: * surgery of hepatic resection by first under costal. * patient classified asa 1 to 3. * information, signed and informed consent exclusion criteria: * patients classified asa 4 or 5. * allergy or intolerance to any of the products used in the protocol. * emergency surgery, palliative surgery, surgical recovery. * history of chronic pain requiring the regular use of analgesics, especially opioids. * history of drug misuse. * inability to understand and / or use the patient's self-controlled morphine pump. * known history of psychiatric disorders or current psychotropic treatment (excluding benzodiazepine monotherapy) * additive behavior with respect to alcohol or non-weaned psychodysleptic substances * pregnant woman or breastfeeding

Keywords: intrathecal morphine, continuous wound infiltration
bioclean mps (multi-purpose solution) vii in combination with biofinity lens: a two week crossover study

Conditions: Myopia

Summary: two week, open label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

to determine if patients are unreactive to the lens care solution / biofinity combination. it is expected that there will be a total of three visits: v1 (initial), v2 (1 week), \& v3 (2 weeks).

Eligibility criteria:
inclusion criteria: * is over 18 years of age (inclusive) * has had a self-reported visual exam in the last two years * has a cl (contact lens) spherical prescription between -0.25d (diopters) and -12.00d (inclusive) * has less than 1.00 d spectacle cylinder in each eye * is correctable to a visual acuity of 20/20 or better in both eyes * has clear corneas and no active ocular disease * has read, understood and signed the informed consent letter * is willing to comply with the wear schedule (at least 40hrs per week) * is willing to comply with the visit schedule exclusion criteria: * has never worn contact lenses before * currently wears rigid gas permeable contact lens * has a history of not achieving comfortable cl (contact lens) wear (5 days per week; \> 8 hours per day) * has a cl prescription outside the range of -0.25d to -12.00d * has a spectacle cylinder greater than -0.75d of cylinder in either eye * has best corrected spectacle distant vision worse than 20/20 in ether eye * has any systemic disease affecting ocular health * is using any systemic or topical medications that will affect ocular health * has any ocular pathology or sever insufficiency of lacrimal secretion * has persistent, clinically significant corneal or conjunctival staining * has active neovascularization or any central corneal scars * is aphakic * is pregnant or lactating
xylitol syrup for the prevention of acute otitis media in otitis-prone children

Conditions: Acute Otitis Media

Summary: the primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear infection) in children with a history of recurrent acute otitis media.


Eligibility criteria:
inclusion criteria: * six months to five years of age * general good health * history of at least three episodes of aom in previous 12 months, at least one of which occurred within the previous six months * english or spanish speaking exclusion criteria: * history of tympanostomy tubes * intestinal malabsorption or chronic diarrhea * diabetes mellitus * any inborn error of metabolism * parent/guardian unreachable by telephone * known allergy to any of the study solution components (xylitol, sorbitol, sodium carboxymethylcellulose, potato starch, glycerin, potassium sorbate, natural berry flavoring).

Keywords: otitis media ear infection
a randomized controlled study of postoperative adjuvant chemotherapy of uracil- tegafur (uft) compared with surgery alone (nsas-cc)

Conditions: Colorectal Cancer

Summary: this is a controlled study designed to compare relapse-free survival and overall survival in patients receiving uft with those in patients receiving surgery alone. patients will be randomly assigned to surgery alone or surgery followed by uft within 6 weeks after curative resection. to assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. to evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.evaluations will be separately done for colon cancer and rectal cancer.


Eligibility criteria:
inclusion criteria: * age 20 to 75 * performance status 0 , 1, or 2 (ecog) * hematopoietic wbc ≥ 4,000/mm\^3 platelet ≥ 100,000/mm\^3 * hepatic ast and alt ≤ 2 times upper limit of normal(uln) total bilirubin ≤ 1.2mg/dl * renal bun ≤ 25mg/dl creatinine ≤ 1.5mg/dl exclusion criteria: * prior anticancer treatment

Keywords: colorectal cancer
immune response after stem cell transplant in hiv-positive patients with hematologic cancer

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; HIV Infection

Summary: this phase ii trial studies the immune response after stem cell transplant in human immunodeficiency virus (hiv)-positive patients with hematologic cancer (blood cancer). studying samples of blood from hiv-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant.

primary objectives: i. examine the development of donor-derived hiv-1-specific immune response following hematopoietic cell transplant (hct) for treatment of hematologic malignancy in hiv+ patients. ii. examine the affect of hct on the pool of latently infected cluster of differentiation (cd)4+ t cells in hiv+ patients given hct for treatment of hematologic malignancy. outline: patients undergo leukapheresis for analysis of hiv-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible.

Eligibility criteria:
inclusion criteria: * hiv positive * treatment with highly active antiretroviral therapy (haart) for at least 1 month * viral load has decreased by \>= 1.5 logs or viral load \< 5000 copies/ml plasma on haart therapy * hematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicated * approval for allogenic regimen given at patient care conference * donor: autologous or allogeneic gene modified cells allowed exclusion criteria: * a medical history of noncompliance with haart or medical therapy * inability to provide informed consent * donor: allogeneic donors must not have hiv infection
effectiveness of therapeutic exercise and education on patients with massive rotator cuff tears

Conditions: Rotator Cuff Injuries

Summary: the aim of this multicenter non-controlled study will be to evaluate the effectiveness of a physical therapy treatment based on resistance exercise and education for patients with massive rotator cuff tears.


Eligibility criteria:
inclusion criteria: * massive rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging. the definition of massive will be the rears including 2 or more tneonds, or the ones with an extension equal or greater to 5cm in the short or long axis. * to have a degree of disability equal or greater to 15% in the oxford shoulder score. * adequate comprehension of written and spoken spanish exclusion criteria: * loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side. * suspected neck-related shoulder pain. * suspected visceral-related shoulder pain. * humerus and/or scapular fractures within the last year. * previous rotator cuff repair surgery within the last year. * presence of cancer, fibromyalgia, neurological and/or other systemic diseases. * cognitive impairment that makes it impossible to perform therapeutic exercise.

Keywords: physical therapy massive rotator cuff tear therapeutic resistance exercise multicenter
new orleans pulmonary hypertension biobank

Conditions: Pulmonary Hypertension; Systemic Sclerosis; Mixed Connective Tissue Disease; Heart Failure With Normal Ejection Fraction; Healthy

Summary: pulmonary hypertension (ph) is a serious condition characterized by a mean pulmonary artery pressure \>=25mmhg on right heart catheterization (rhc). despite advances in ph care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can guide clinical care. the investigators are establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary hypertension, patients at high risk for pulmonary hypertension, healthy controls, and patients undergoing right heart catheterization. specimens will be stored for future investigations.


Eligibility criteria:
inclusion criteria: * diagnosis of pulmonary hypertension and followed at the comprehensive pulmonary hypertension center or * diagnosis of systemic sclerosis and followed at the comprehensive pulmonary hypertension center or * diagnosis of mixed connective tissue disease and followed at the comprehensive pulmonary hypertension center or * undergoing outpatient right heart catheterization exclusion criteria: * age\<18 * pregnant * unable to understand english * currently incarcerated * unwilling or unable to sign informed consent
bioequivalence of two formulations of biphasic insulin aspart 50 in healthy japanese subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (nn-x14mix50) in healthy japanese subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history and physical examination, as judged by the investigator or sub-investigator. * body mass index (bmi) between 19-29 kg/m\^2 (inclusive) * fasting plasma glucose between 3.8-6.0 mmol/l (both inclusive) exclusion criteria: * clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the investigator or sub-investigator * any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the investigator or sub-investigator * any inter-current illness that might affect blood glucose, as judged by the investigator or sub-investigator * hepatitis b or c, or hiv (human immunodeficiency virus) positive * subjects with a first degree relative with diabetes mellitus * history of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder * subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse * subjects who smoked more than 5 cigarettes per day * subjects who had taken part in strenuous exercise within 7 days prior to the screening
pregnancy intervention revolving around goal-focused education (girafe)

Conditions: Pregnancy

Summary: the purpose of study is to learn if consuming ≥30 grams or more of fiber per day can help pregnant women gain an appropriate amount of weight during their pregnancy.


Eligibility criteria:
inclusion criteria: * women between 9 to 15 weeks pregnant * bmi between 22.0 - 40.0 kg/m2 and between the * ages of 18-45 years * able to be recruited from the university of kansas medical center (kumc). exclusion criteria: * no internet access * consuming more than 20 grams per day of fiber * and/or with the following medical conditions during pregnancy: * pre-gestational diabetes * diagnosed with diabetes * pre-eclampsia * hypertension * other metabolic abnormalities * asthma * heart disease * smoking * drug abuse * pregnancies of multiples

Keywords: dietary fiber gestational weight gain
exenteration: quality of life study and rehabilitation rate according to the reconstruction technique (etre)

Conditions: Cancer

Summary: prospective monocentric quality of life study. including all patients who have been exentered at the institut curie paris, from january 2004 to december 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone. the sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in french, in the context of ent surgery: the fact-g and fact-mbis questionnaires.

it is now obvious to all surgeons involved in the follow-up of these patients that not all orbital reconstruction techniques are equal. thus, through this study, the investigators wish to objectively highlight the gain in quality of life and prosthetic equipment in exentered patients, depending on the reconstruction method used. this prospective study, including all patients who have been exentered at the institut curie paris, from january 2004 to december 2019, proposes to compare the reported quality of life of patients according to the reconstruction technique patients have undergone. the investigators will evaluate the quality of life of our patients by means of two validated questionnaires, in french, in the context of ent surgery: the fact-g and fact-mbis questionnaires. the investigators will submit them, after express telephone agreement, by post to all the patients included in our study. the aim of such a study will therefore be to provide assistance to both surgeons and patients in the choice of an orbital reconstruction technique, by objectively demonstrating the superiority of one technique over the others in terms of quality of life and prosthetic equipment rate. the patients included in this study will have to answer two questionnaires, submitted by post. this study therefore falls within the framework of minimal or moderate risk studies. the patients will be informed by telephone interview about the method of writing the questionnaires and their content. the investigators will pay particular attention to the quality of life of the patients who have benefited from a free ante-brachial flap reconstruction in comparison with other reconstruction techniques; this will constitute the main criterion of our study. in addition, the collection of pseudo-anonymised computerised data from all the patient files will give rise to a comparison of post-operative healing times, the rate of prosthetic fitting, and the time taken to fit the prosthesis according to the reconstruction techniques. these three factors, already identified in the literature as indicators of good rehabilitationn , will constitute our secondary judgment criteria.

Eligibility criteria:
inclusion criteria: all patients, living or lost, exentered at the institut curie paris between january 2014 and december 2019, exclusion criteria: * persons under court protection. * persons not in a condition to give their consent.

Keywords: exenteration surgery quality of life
correlation between changes in lung function and changes in cough and dyspnoea in nintedanib-treated connective tissue disease interstitial lung disease (ctd-ild) patients

Conditions: Lung Diseases, Interstitial

Summary: the aim of this study is to identify correlations between change from the baseline at month 24 in forced vital capacity (fvc) (% predicted and ml) and change from the baseline at month 24 in cough or dyspnoea scores \[points\] as measured in the living with pulmonary fibrosis questionnaire (l-pf) over 24 months of nintedanib treatment in patients with connective tissues disease-associated progressive fibrosing interstitial lung disease (ctd associated pf-ild) under routine clinical practice conditions in greece.


Eligibility criteria:
inclusion criteria: * age ≥18 years with a confirmed physician diagnosis of connective tissue disease (ctd) associated progressive fibrosing interstitial lung disease (pf-ild) * have been prescribed nintedanib according to the local summary of product characteristics (smpc) and clinical judgment. therapy with nintedanib must have been started for clinical reasons independently from the intended patient enrolment into the study at a maximum of 15 days before enrolment into the trial. exclusion criteria: * patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nintedanib * patients at baseline with a known condition or reason that will result in withdrawal from the study before the 24-month time point * pregnancy or lactation
autologous stem cell transplant for multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis is an autoimmune disease. we are studying whether high dose chemotherapy and autologous stem cell transplant can replace the autoreactive immune system and if this reduces clinical inflammatory disease in the central nervous system (cns). a second goal is to examine whether there is long-term stabilization or improvement in disability scores if the inflammatory disease is controlled.


Eligibility criteria:
inclusion criteria: * age between 18 and 50 years * the diagnosis of active multiple sclerosis with relapses or progression and sustained accumulated impairment, made by a neurologist expert in the field * patient considered at high risk of progression * edss cerebellar functional score greater than or equal to 3 or edss pyramidal functional score greater than or equal to 3 * edss between greater than or equal to 3 and less than or equal to 6 * evidence of current disease activity * evidence of progression or continued relapses or worsening mri after at least one year of therapy with interferon-b1, glatiramer acetate, mitoxantrone, or other conventional dose immunosuppressive drug therapy * if a patient has previously received a cytotoxic agent (mitoxantrone, cyclophosphamide etc.) they must have normal bone marrow morphology and cytogenetics before being considered eligible for this study * mri brain scan that satisfies the mri criteria of paty or fazekas for the diagnosis of multiple sclerosis * no evidence of hepatic inflammation or fibrosis exclusion criteria: * patients with primary progressive multiple sclerosis * patients with cardiac, renal, pulmonary, hepatic or other organ impairment that would limit their ability to receive dose intensive immunosuppressive therapy including high dose chemotherapy and asct * patient with any active or chronic infection * patients who are seropositive for hiv1, hiv2, hepatitis b surface antigen, and hepatitis c * patients with a previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year * patients whose life expectancy is severely limited by another co-morbid illness * patients with evidence of myelodysplasia or other non-autoimmune cytopenia * patients having received a cytotoxic agent within one month of enrolling in this study * pregnancy or risk of pregnancy. this includes patients that are unwilling to practice active contraception during the time of chemotherapy * patients with hypersensitivity to rabbit proteins * patients unable to give written informed consent in accordance with research ethics board guidelines * patients having previous exposure to natalizumab or alemtuzumab.

Keywords: immunoablation stem cell transplantation