Kornimate/medical-research-clean huggingface dataset:
peprostat haemostat study in subjects undergoing liver surgery

Conditions: Hemorrhage

Summary: the purpose of this first in man study is to evaluate the safety and tolerability, as well as to explore efficacy of peprostat, a new peptide based coagulant (haemostat), when used in patients undergoing open liver resection surgery.


Eligibility criteria:
inclusion criteria: * are able and willing to provide written informed consent to participate in this study, confirmed by signing the informed consent documents * adult males and females ≥18 years of age * female subjects must be post-menopausal. post-menopausal status is defined as any of the following: natural menopause with menses \>1 year ago; radiation induced oophorectomy with last menses \>1 year ago; chemotherapy induced menopause with 1 year interval since last menses * willing and able to comply with all protocol requirements including follow-up * subject must have a haemoglobin ≥ 9.0 g/dl at screening * subject must have a platelet count ≥ 100,000/mm3 at screening * subject is undergoing a planned open liver resection * male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow-up visit * during the surgery, the subject presents an identified target bleeding site (tbs) with oozing, mild or moderate bleeding, which conventional surgical techniques are insufficient to control and would otherwise be a candidate for standard haemostats * during the surgery, subject presents no intraoperative complications, other than bleeding, that may interfere with study assessments as judged by the investigator exclusion criteria: * subject is undergoing emergency surgical procedure * recipient of a liver transplant * females of child-bearing potential * active infection at the time of the liver resection * international normalized ratio (inr) \> 2.0 or aptt ratio \> 2.0 at screening * fibrinogen level \< 1.5g/l at screening * history of thromboembolic disease and/or thrombophilia * any other disease or condition that may affect normal blood clotting, for example thrombocytopenia, as judged by the investigator * a known history of anaphylaxis or allergic reaction to human albumin, pegylated proteins, yeast or moulds, porcine products or other components in the imp * participation in another investigational drug or device research study within 30 days before and after enrolment in the current study * current known or suspected alcohol and/or drug abuse or dependence at the time of screening * any concurrent medical, surgical, or psychiatric condition that may, in the investigator's opinion, affect the subject's willingness or ability to meet all study requirements during the study duration * during the surgery, subject presents severe bleeding where use of a topical haemostat would be inappropriate * subject is taking any prohibited medications * bmi at screening of ≥35

Keywords: haemostat liver surgery primary liver cancer metastatic liver cancer benign liver disease such as adenoma hepatitis-related or alcoholic-related liver cirrhosis living donation for liver transplant
trigeminal nerve stimulation for attention deficit hyperactivity disorder (adhd)

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: this proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (tns) as a treatment for attention-deficit/hyperactivity disorder (adhd). if successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.


Eligibility criteria:
inclusion criteria: * male and female youth age 9 to 14 years with diagnostic and statistical manuel -iv (dsm-iv) adhd, combined subtype as determined by kiddie schedule for affective disorders and schizophrenia (ksads) and clinical interview * minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline adhd-rating scale (adhd-rs)s * clinical global impression- severity (cgi-s) score at baseline * no current medications with central nervous system (cns) affects * parents able and willing to monitor proper use of the stimulation device and complete all required rating scales. exclusion criteria: * impaired functioning to a degree that requires immediate initiation of adhd medication in the opinion of the parents and/or investigator; 2) current diagnosis of pervasive developmental disorder or major depression. * history of lifetime psychosis or mania * current suicidality * history of seizure disorder, tic disorder, or head injury with loss of consciousness.
postpartum weight loss and sleep amongst obese women

Conditions: Obesity; Sleep Disordered Breathing; Weight Loss; Postpartum; Insomnia

Summary: this study will be a randomized controlled trial involving obese women obtaining prenatal care at an obstetric care clinic. study subjects will undergo prenatal care in a group setting or prenatal care with a behavioral intervention to improve sleep. anthropometric measurements, blood draws, questionnaires and at home sleep studies will be completed at three specified times (two antepartum and one postpartum). primary outcome will be a comparison of postpartum weight loss amongst the intervention and control groups.


Eligibility criteria:
inclusion criteria: * • pregnant female patients * currently receiving obstetrical care at the tgh health park genesis clinic * between in the second trimester at entry into the study * overweight or obese defined as a pre-pregnancy body mass index greater than or equal to 25.0 kg/msquared * over 18 years of age * able to speak and understand as well as give informed consent in english * have access to internet services * have reported nightly sleep duration of \<6.5 hours exclusion criteria: * • under 18 years of age * pre-existing type 1 or 2 diabetes mellitus * pre-existing obstructive sleep apnea * current use of sleep medication * serious physical or mental illness or condition that would substantially interfere with participation in, or completion of, the entire intervention
dry needling versus intramuscular stimulation in the management of the myofascial trigger points

Conditions: Trigger Point Pain, Myofascial; Muscle Pain; Myofascial Pain Syndrome

Summary: hypothesis the application of intramuscular electrostimulation will be more effectiveness than the dry needling in myofascial trigger points treatment. objetives: to determine the effectiveness of intramuscular electrostimulation in the treatment of trigger points of the levator scapula muscle for the improvement of pain in mechanical cervicalgia. participants: subjects with diagnosed of myofascial pain syndrome in cervical region and active trigger points in levator scapulae muscle, randomly assigned to experimental or control group. intervention: control group: one session of dry needling in active trigger points; experimental group: one session of intramuscular stimulation in active trigger points. main outcomes measures: pain, pressure pain threshold (ppt), active cervical range of motion and strength muscle . the measures will be taken before, after and one week after the interventions.

the muscle pain is one of the most common forms of musculoskeletal pain. within muscular pain, the presence of myofascial trigger points (pg) in the musculature is a important and prevalent problem. currently one the techniques most used in the treatment of pg is dry needling. dry needling has been shown effective in the treatment of neck pain associated with pgs. to our knowledge, there are no studies that they have compared the effectiveness of dry needling and intramuscular stimulation by applying an electric current. this study is a randomized clinical trial that aims to demonstrate that the application of an electric current associated with dry needling in the treatment of pg. in this study we will treat subjects with cervical pain who they have active pgs in the levator scapulae muscle.

Eligibility criteria:
inclusion criteria: * cervical pain. * active trigger points in levator scapulae muscle exclusion criteria: * pain irradiation toward upper limb * psychological disorders * whiplash. * neuropathic symptoms * cervical and / or shoulder spine surgery
constitution of ex vivo ovarian tumor models for the validation of the interest of innovative therapies and the search for tumor or circulating biomarkers predictive of treatment response

Conditions: Ovarian Cancer

Summary: development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.


Eligibility criteria:
inclusion criteria: * patient over 18 years old. * patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. all figo stages are accepted for the study. * patient to be managed by surgery (laparoscopy and / or laparotomy). exclusion criteria: * pregnant woman * persons deprived of liberty or guardianship (including curatorship) * history of any other clinically active malignancy in the last 5 years prior to inclusion

Keywords: ex vivo predictive tests tumor models
transplantation of nicord®, umbilical cord blood-derived ex vivo expanded cells, in patients with hm

Conditions: Hematological Malignancies; Acute Lymphoblastic Leukemia (ALL); Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS)

Summary: a study evaluating the safety and efficacy of transplantation of a single cord blood unit (cbu) of nicord®, umbilical cord blood-derived ex vivo expanded stem and progenitor cells in patients with hematological malignancies.

umbilical cord blood (ucb) is an alternative stem cell source for hematopoietic stem cell transplantations (hsct) and can be used for the treatment of various life-threatening diseases, such as hematological malignancies or genetic blood disorders, in such cases where a matched related stem cell donor is not available. however, the major drawback of using this valuable stem cells source is the limited cell dose in a single cord blood unit (cbu), which was shown to be associated with inadequate hematopoietic reconstitution and high risk of transplant-related mortality. to improve outcomes and extend applicability of ucb transplantation, one potential solution is ex vivo expansion of ucb-derived stem and progenitor cells. nicord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic ucb cells. nicord® is based on a novel technology for the ex vivo cell expansion of cord blood derived hematopoietic progenitor cells. by increasing the number of the short and long-term reconstitution progenitor cells transplanted, nicord® has the potential to enable the broader application of ucb transplantation, and improve the clinical outcomes of ucb transplantation. the study is designed as a multi center, single arm study, evaluating the safety and efficacy of the transplantation of nicord® to patients with hematological malignancies following myeloablative therapy. total study duration is approximately 400 days from the signing of informed consent to the last visit one year following transplantation the overall study objective is to evaluate the safety and efficacy of nicord®: single ex-vivo expanded cord blood unit transplantation in patients with hematological malignancies following myeloablative therapy as follows: the main study objectives are to assess the cumulative incidence of patients with nicord®-derived neutrophil engraftment at 42 days following transplantation and to assess the incidence of secondary graft failure at 180 days following transplantation of nicord® ten evaluable patients recruited for the study should be 12-65 years of age, up to a maximum of 15 treated patients.

Eligibility criteria:
inclusion criteria: * applicable disease and eligible for myeloablative sct * patients must have two partially hla-matched cbus * back-up stem cell source * adequate karnofsky performance score or lansky play-performance scale * sufficient physiological reserves * signed written informed consent exclusion criteria: * hla-matched donor able to donate * prior allogeneic hsct * other active malignancy * active or uncontrolled infection * active/symptoms of central nervous system (cns) disease * pregnancy or lactation
comparsion of king vision® standard blade and king vision® channeled blade in patients scheduled for tracheal intubation

Conditions: Hypoxemia

Summary: comparison of intubation time from the time to fix the trachealtube to the first end-tidal co2 ventilation by means of the curve on the ventilator at kv standard blade and kv channeled blade

in the proposed clinical trial the time measured until the first manual ventilation at 44 study participants with elective anesthesia by using the kv standard blade and kv channeled blade. bedside the time for tracheal intubation, we documented the view on the monitor which is connected to the instrument, the c\& l classification and pogo scale.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years no concurrent participation in another study * capacity to consent * present written informed consent of the research participant * elective surgery under general anesthesia exclusion criteria: * age \<18 years * existing pregnancy * lack of consent * inability to consent * emergency patients * emergency situations in the context of a difficult airway management * asa classification\> 3 * situations where the possibility of accumulated gastric contents * participation in another study

Keywords: airway videolaryngoscope
antineoplaston therapy in treating patients with primary liver cancer

Conditions: Primary Liver Cancer

Summary: current therapies for primary liver cancer provide very limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of primary liver cancer. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with advanced head and neck cancer.

primary liver cancer patients receive gradually escalating doses of intravenous antineoplaston therapy (atengenal + astugenal) until the maximum tolerated dose is reached. treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. objectives: * to determine the efficacy of antineoplaston therapy in patients with advanced primary liver cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * to determine the safety and tolerance of antineoplaston therapy in patients with advanced primary liver cancer. * to determine objective response, tumor size is measured utilizing mri scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed primary liver cancer that is unlikely to respond to existing therapy and for which no curative therapy exists * measurable disease by ct scan or mri * tumor must be at least 2 cm patient characteristics: age: * 14 and over performance status: * karnofsky 60-100% life expectancy: * at least 2 months hematopoietic: * wbc at least 2,000/mm3 * platelet count at least 50,000/mm3 hepatic: * bilirubin less than 3 mg/dl * sgot/sgpt no greater than 10 times upper limit of normal * no hepatic failure renal: * creatinine no greater than 2.5 mg/dl * no history of renal conditions that contraindicate high doses of sodium cardiovascular: * no uncontrolled hypertension * no known chronic heart failure * no history of congestive heart failure * no history of other cardiovascular conditions that contraindicate high doses of sodium pulmonary: * no serious lung disease (e.g., chronic obstructive pulmonary disease) other: * not pregnant or nursing * fertile patients must use effective contraception for 4 weeks before study, during study, and for 4 weeks after study * no serious medical or psychiatric disease * no active infection prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy and recovered * no concurrent immunomodulating agents chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * no concurrent antineoplastic agents endocrine therapy: * concurrent steroids allowed radiotherapy: * at least 8 weeks since prior radiotherapy and recovered surgery: * recovered from prior surgery other: * no prior antineoplaston therapy * prior cytodifferentiating agents allowed

Keywords: childhood primary liver cancer adult primary liver cancer
effects of toa versus pnf techniques on trunk control in children with hemiplegic cerebral palsy

Conditions: Hemiplegic Cerebral Palsy

Summary: cerebral palsy occurs in 2-2.5 per 1000 live births, seems to be the most common cause of lifelong physical disability, and has an impact on the child, caregivers, and society. the incidence of cerebral palsy continues to rise owing to the large numbers of premature and high-risk infants who survive. task-oriented arm approaches promote intensive, meaningful, and goal-oriented training in subjects, and the voluntary functional activities of these subjects possibly reduce their motor disabilities.

the study will be randomized clinical trial used to evaluate the effectiveness of toa and pnf on trunk control in children with hemiplegic cerebral palsy. subjects with hemiplegic cerebral palsy meeting the inclusion and exclusion criteria will be divided into two groups using non- probability sampling techniques. assessment will be done using trunk control measuring scale and pediatric reach test . group a will receive toa and conventional therapy and group b will receive pnf and conventional therapy.

Eligibility criteria:
inclusion criteria: * the level of gross motor function between i and iii in accordance with the gross motor function classification system (gmfcs) * the degree of spasticity in the affected lower extremity between grade 1 and 1+ in accordance with the modified ashworth scale * 6-12 years of age * ability to understand and follow verbal instructions exclusion criteria: * surgical procedures within the past 6 months * botox injection within 6 months * unstable seizures * other comorbidity condition (multiple disabilities)

Keywords: cp hemiplegia rhythmic initiation rhythmic stabilization toa
using the drug thalidomide to stimulate t cells in hiv-infected people

Conditions: HIV Infections

Summary: despite treatment with anti-hiv drugs, people infected with hiv continue to have problems with their immune systems. this study will evaluate whether the drug thalidomide, which stimulates the immune system's t cells, can improve immune system function in people with hiv.

in patients with chronic hiv infection, hiv replication and abnormalities in immune function persist following treatment with highly active antiretroviral therapy (haart). specifically, costimulatory t cell interactions are impaired. the immune modulatory drug thalidomide was recently found to costimulate t cells. pharmacologic t cell costimulation may compensate for the t cell deficiencies in people with hiv disease and improve immune function. this study will test whether thalidomide treatment enhances hiv and cytomegalovirus (cmv)-specific immunity in patients with hiv and cmv, and will evaluate the effect of thalidomide on hiv replication. in this study, 40 hiv and cmv infected patients on haart and 40 hiv uninfected cmv seropositive controls will be randomly assigned to low dose thalidomide or placebo treatment for 28 days. t cell responses and hiv replication and genetic diversification will be assessed.

Eligibility criteria:
inclusion criteria * hiv-infected for at least 5 years prior to study entry * cd4 count of 300/mm3 or above * pre-haart nadir cd4 count of 300/mm3 or less * cmv infection * haart for 12 months prior to study entry * same effective haart regimen for 3 months prior to study entry * hiv viral load less than 200 copies/ml * clinically stable exclusion criteria * active opportunistic infection * females of childbearing potential

Keywords: immune modulation thalidomide immune reconstitution treatment experienced
cosmetic outcome of leishmaniasis scar after wr279396 application

Conditions: Cutaneous Leishmaniasis; Scar

Summary: primary objectives: assess whether cl (caused by leishmaniasis major) lesions treated with wr279396 improved the cosmetic outcome compared with no treatment (natural healing)

secondary objectives 1. evaluate the cosmetic outcome of cl lesions treated with "vehicle" compared with no treatment (natural healing) 2. evaluate the cosmetic outcome of cl lesions treated with "vehicle" compared with wr279396 * to determine whether cl lesions treated with vehicle improves the cosmetic outcome (compared with natural healing) * to determine whether cl lesions treated with vehicle alone provides a cosmetic outcome similar to wr279396

Eligibility criteria:
inclusion criteria: * included are volunteers who participated in wrair 813 (hsrrb log # 9768.1) and those who participated in another cl study in/around the wrair 813 study site who had been assigned to a "no-treatment" (natural healing) arm. all volunteers will have had documented cl in the past that were treated with wr279396, vehicle, or no treatment (natural history), have signed informed consent, and are willing to comply with study assessments; age range: 5 to 75 years old. * for study subjects who were enrolled in wrair 813 in 2004 (wr279396 or vehicle treated): * written informed consent obtained from the subject or guardian * willing to meet the requirements of the single clinic visit * prior data in the clinical site data base documenting a diagnosis of cl * each lesion for inclusion in this study conforms to wrair 813: ³ 1 cm in diameter and was primarily ulcerative (i.e., not verrucous or nodular) * the index lesion and others to be scored were proven parasitologically by giemsa slide smear * cl scars documented to be \> 360 days old (clock starts at time of diagnosis) * no treatment of the lesions other than that received in the previous protocol * study subjects from the earlier studies to serve as "no treatment" controls: * written informed consent obtained from the subject or guardian * willing to meet the requirements of the single clinic visit * same age range as wrair 813: 5-75 years old at time of diagnosis * prior data in the clinical site data base documenting a diagnosis of cl, and that the volunteer was assigned to the "no treatment" group * each lesion for inclusion in this study will conform to wrair 813: at the time of diagnosis, ≥1 cm in diameter and described as primarily ulcerative (i.e., not verrucous or nodular) * at least 1 lesion that was proven parasitologically by giemsa slide smear for inclusion in the earlier study. * cl scars documented to be \> 360 days old (clock starts at time of diagnosis) * never received any treatment of the lesions (natural healing) or applied any medication, such as herbal medication * lesions present on the trunk or extremities, to match the wrair 813 study volunteers (no facial lesions were treated in the 2004 study) exclusion criteria: * potential volunteers without a prior documented diagnosis of cl

Keywords: paromomycin gentamicin