Kornimate/medical-research-clean huggingface dataset:
fall recovery training for individuals with chronic stroke

Conditions: Stroke

Summary: the purpose of this study is to quantify how fall-recovery training improves the fall-recovery response of individuals with chronic stroke. up to 20 participants with chronic stroke will be recruited from the community. over six laboratory visits, participants will undergo sessions of fall-recovery training. each session is comprised of simulated trips and slips as participants stand on a computer-controlled treadmill. trip-recovery training consists of treadmill-delivered disturbances that induce a forward fall. slip-recovery training consists of a treadmill-delivered disturbances that induce a backward fall. separate progressions focus on initial steps with the left and right limbs. the training intensity, as determined by the disturbance magnitude, is progressive and dependent on participant performance. step length and maximum trunk angle will be calculated. the hypothesis is that, with practice, participants will recover from larger perturbations, and they will increase step length and reduce trunk rotation during fall recoveries.


Eligibility criteria:
inclusion criteria: * participants must be 18 years or older * participants must have had a single stroke of non-cerebellar origin exclusion criteria: * more than one stroke * unable to walk one block without stopping or using a walking aid, such as a cane * acute illness at the time of functional assessment or training * body mass greater than 136 kg (300 lbs) * lower extremity joint replacement or shoulder joint replacement within a year prior to participation * dementia * parkinson's disease * a history of back surgery * a history of neck surgery * more than one occurrence of back or neck pain in the month prior to participation * current back or neck pain at the time of participant enrollment * bulging vertebral discs * spine, hip, or lower extremity fracture within a year prior to participation * open lesions on the lower extremity * insulin-dependent diabetes * use of a pacemaker * use of an ostomy pouch * pregnancy * osteoporosis * doctor recommendation to avoid moderate physical activity or exercise * any neural, muscular, or skeletal condition or injury that precludes safe participation in the training or introduces a confounding factor on the study, at the discretion of the clinician or study staff
preterm delivery after septum resection

Conditions: Septum; Uterus; Infertility, Female; Preterm Birth

Summary: uterine septum is the most common congenital uterine malformation. it accounts for approximately 35% of all uterine malformations, while the frequency of uterine malformations in the general fertile population is estimated to be between 1% and 4%. the presence of a uterine septum is associated with subfertility and a high incidence of obstetric complications, such as spontaneous abortion, 3-fold increase in preterm premature rupture of the membranes (prom), 6-fold increase in preterm delivery, malpresentation at delivery, caesarean section, and increased perinatal morbidity and mortality. some studies have found that surgical resection of the uterine septum improves pregnancy outcomes and significantly reduces the risk of preterm delivery. therefore, the risk for a short-term adverse outcome and long-term sequelae due to preterm delivery such as intraventricular hemorrhage, necrotizing enterocolitis, sepsis, patent ductus arteriosus, retinopathy, deafness, chronic lung disease, cerebral palsy, perinatal death, and impaired mental development in women with uterine septum could be lowered by performing a relatively simple and safe hysteroscopic septum resection (hsr). however, there are two major concerns regarding hsr: cervical incompetence due to excessive dilatation during hysteroscopy and the rare yet serious complication of uterine rupture in subsequent pregnancy or delivery. considering these elements, the aim of this study will be to evaluate the rate of preterm delivery in singleton pregnancy comparing primary infertile women who underwent hsr and who did not undergo the same procedure, with our without in vitro fertilization.


Eligibility criteria:
inclusion criteria: * female primary infertility * singleton pregnancies exclusion criteria: * female secondary infertility * multiple pregnancies

Keywords: hysteroscopy metroplasty primary infertility preterm delivery
sodium lactate versus hypertonic saline solution in the treatment of intracranial hypertensive episodes in severe brain injured patients

Conditions: Intra Cerebral Hypertension; Lactate Sodium Solution

Summary: brain oedema is a major complication of brain injury (tbi). it increases the risk of intracranial hypertension (ich) and brain hypoxia, leading to an increase in mortality and poor neurologic outcome. increased water content in the injured brain can be related to a vasogenic or cellular pathway. osmotherapy, by using mannitol or hypertonic saline (hss), is recommended and currently administered for the treatment of ich in this setting. beside these two usual treatments, sodium lactate (sl), a metabolic and neuroprotective solution, has recently been described as having similar effects on lowering intracranial pressure (icp). in a previous study, conducted in patients with severe tbi, (1) ichai et al. reported that a bolus of half-molar sl was as effective than equimolar doses of mannitol to reduce elevated icp (less refractory ich and higher and longer reduction of ich). objective(s): the purpose of the study is to analyze the effect on ich of sl compared to a hypertonic saline solution (hss). outcome(s): the primary endpoint is the efficacy in lowering ich after 4 h. secondary endpoints were percentage of successfully treated episodes of intracranial hypertension and neurological status at discharge from icu.


Eligibility criteria:
inclusion criteria: * patient with an acute, isolated, severe brain injury (sah, tbi, ich) * glasgow coma score \<8 * monitored using icp device * presenting an episode of intracranial hypertension requiring osmotherapy. ( defined as increase in icp 25 mmhg which persisted for more than 5 min in the absence of noxious stimulations) * informed consent as documented by signature exclusion criteria * pregnant woman * bilateral fixed dilatated pupils * initial hypernatremia (\>155 mmol/l) * penetrating head injury * active participation to another trial (clin b, c)

Keywords: intracerebral hypertension lactate sodium
combination of ultrasound treatment and neck liposuction for skin tightening

Conditions: Skin Laxity

Summary: the purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.


Eligibility criteria:
inclusion criteria: * women 35-60 years old * exhibit mild to moderate neck skin laxity on clinical examination * no other serious health problems, including psychiatric illness. exclusion criteria: * prior neck surgery or face lift. * bleeding disorders or coagulopathy. * botulinum toxin or filler injections to neck area within past 6 months. * severe neck skin laxity or sagging * other serious medical conditions that in the opinion of the surgeon could compromise safety
accuracy& orbital volume using patient specific titanium implant vs zirconia for orbital floor reconstruction

Conditions: Blow-Out Fractures; Orbital Fractures; Orbital Floor Fracture; Orbital Trauma

Summary: comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures .

patients of both groups will be subjected to: 1. case history including personal data, medical, surgical history and family history. 2. a full examination of the cranial and maxillofacial skeleton and soft tissue . 3. evaluation of visual functions 4. ophthalmologic consultation and clearance 5. radiographic examination: ct scan 6. all dicom data will be imported to the surgical planning software. virtual planning: 1. a midsagittal plane will be constructed then the normal orbit will be mirrored to the affected side. 2. the mirrored orbital floor will be meshed with 1.6 mm holes then its peripheries will be extended downwards by 3 mm and meshed also in order to accommodate the fixation. 3. the designed part will be subtracted then exported in stereolithography (stl) format to be fabricated . the surgery will be done under general anesthesia and undertaken within 14 days to prevent fibrosis. can be delayed 24-72 hours to allow the edema to subside before undertaking surgery. intervention group: - • the stl file will be milled from zirconium and then will be ready for sterilization and intraoperative fixation - a transconjunctival incision will be done to allow for good exposure that optimizes visualization of the orbital floor during the repair and insertion and fixation of the patient specific zirconia implant. control group: - • the stl file be milled from grade 4 titanium and then will be ready for sterilization and intraoperative fixation with the same surgical steps. follow up: all patients will be examined clinically and radiographically, during postoperative 1st and 2nd week . only one postoperative ct scan will be done after 2 weeks.

Eligibility criteria:
inclusion criteria: * patients with blow out fracture isolated and / or combined with other fracture. * age group: from 18 to 60 years old * no sex predilection * patients with no contraindications to surgical intervention. * patients willing for the surgical procedure and follow-up, with an informed consent. exclusion criteria : * medically compromised patients. * patients with history of previous orbital reconstruction surgery. * uncooperative patients. * patients with systemic contraindication to general anesthesia.
a study of the efficacy and safety of ziprasidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms

the study was prematurely discontinued due to the difficulty of subject recruitment on march 24, 2005. there were no safety concerns that led to the decision to terminate.

Eligibility criteria:
inclusion criteria: * patients not currently being treated with antipsychotic medication and neuroleptic naive patients * diagnosis of schizophrenia or schizoaffective disorder * antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years exclusion criteria: * patients at immediate risk of committing harm to self or others * treatment with clozapine within 3 months prior to baseline * history of neuroleptic treatment * current antipsychotic treatment
immune profiles evolution under immunotherapy for melanoma

Conditions: Melanoma

Summary: the primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort a) or in metastatic setting(cohort b); and to study the association of these immune profiles with relapse- or progression-free survival.

this study will analyse the association of biomarkers with relapse- or progression-free survival of stage iii or iv melanoma patients, divided in 3 sub-cohorts: * patients treated in the adjuvant setting (cohort a): new user of immune checkpoint blockers. * patients treated in the metastatic setting (cohort b): - b1: new users of immune checkpoint blockers; - b2: prevalent users of immune checkpoint blockers treated with complementary radiotherapy. for patients of cohort a and b1, immune profiles characteristics will be evaluated before initiation of treatment (=baseline), and at each radiological evaluation of the tumour response, up to maximum 12 months as duration. the maximal duration of treatment will be 12 months for patients treated in the adjuvant setting. for metastatic patients, the duration of treatment will be decided by physician according to different factors (responses, progression, toxicities, ...). for patients in cohort b2, the characteristics of the immune profiles will be evaluated before radiotherapy initiation,, within 6 weeks after the end of radiotherapy, then at the 2 following radiological evaluations of the tumour response

Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years; * totally resected stage iii or iv melanoma totally resected, treated with a immune therapy (pembrolizumab or nivolumab ou other immune checkpoint inhibitors) as adjuvant treatment; * unresectable stage iiic/d or iv metastatic melanoma, treated with immune therapy (pembrolizumab or nivolumab or immune checkpoint inhibitors) which should be associated by a radiotherapy ; * patient has been informed about the study and signed the consent; * affiliated to the french social security scheme. exclusion criteria: * pregnant or breastfeeding woman; * patient refusal; * patient receiving a immunosuppressor; * undergo a general corticotherapy of \> 10 mg/kg/day since more than 7 days; * patient who participate to another blind interventional study receiving blinded treatment; * patient without any social protection by organization.

Keywords: melanoma immunotherapy immune profiles
cardiac electrophysiological study

Conditions: Atrial Flutter

Summary: the purpose of the study is to measure the effects of azd1305 on cardiac electrophysiological properties and intracardiac pressures


Eligibility criteria:
inclusion criteria: * patients with atrial flutter (with a ventricular rate of \<100 beats/minute at enrolment), scheduled for curative catheter ablation * sinus rhythm at randomisation exclusion criteria: * qtc (fridericia, qtcf ) \>450 ms measured in sinus rhythm at randomisation, * serum potassium below 3.8 or above 5.0 mmol/l or plasma potassium below 3.6 or above 5.0 mmol/l * qrs duration \>120 ms at randomisation
reccord (recording courses of vascular diseases) registry

Conditions: Vascular Diseases; Peripheral Artery Disease; Claudication; Critical Limb Ischemia; Diabetic Foot

Summary: the recording courses of vascular diseases registry (reccord registry) is an observational, prospective, multicentre, all-comers registry platform. in the initial phase, patients referred for endovascular revascularization of peripheral artery disease (pad) of the lower limbs will be prospectively included and followed up for at least one year. at baseline, data on patients' demographic characteristics, comorbidities, previous peripheral interventions, medication, and clinical stage of pad (rutherford category), haemodynamic parameters, and procedural data including complications will be assessed. major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and at any unplanned visits. for details see nm malyar et al., rationale and design of the recording courses of vascular diseases registry (reccord registry). vasa. https://doi.org/10.1024/0301-1526/a000631

for details see nm malyar et al., rationale and design of the recording courses of vascular diseases registry (reccord registry). vasa. https://doi.org/10.1024/0301-1526/a000631

Eligibility criteria:
inclusion criteria: * any type of endovascular interventions for symptomatic pad * endovascular intervention for pad of lower extremities, i.e. below the aorto-iliac bifurcation exclusion criteria: * patients undergoing hybrid-(surgical and endovascular) and/or surgical interventions for symptomatic pad * patients with a life expectancy of \<6 months * endovascular intervention for reasons other than symptomatic pad

Keywords: vascular diseases peripheral artery disease revascularisation outcome quality management registry endovascular intervention limb amputation
simplified antibiotic therapy for sepsis in young infants

Conditions: Neonatal Sepsis; Sepsis; Infection

Summary: this trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban karachi where hospital referral is frequently refused by families.

primary objective to evaluate if out-patient (clinic-based) therapy of young infants with possible serious bacterial infection with 7 days of intramuscular procaine penicillin and gentamicin (reference therapy) is equivalent to: * (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; * (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and hypothesis the proportion of babies who fail therapy at (or before 7) days will be 10% in each group. a 5% or less difference in failure rates will be considered equivalent. study design this will be a randomized, three arm, open-label equivalence trial among young infants, 0-59 days of age who are diagnosed as having possible serious bacterial infection in one of the karachi field clinics, and whose families refuse facilitated hospital referral, and the infants meet other specified inclusion criteria. eligible young infants will be recruited from among those referred to the clinics by trained community health workers as having clinical signs predictive of possible serious illness during regular home visits in the surveillance area, or those presenting directly to the clinics from the areas under pregnancy and newborn surveillance. a diagnosis of possible sepsis will be made by clinicians if specified clinical criteria are met.

Eligibility criteria:
inclusion criteria: * inclusion criteria * infants 0-59 days old who are residents of catchment population of the study hospitals or clinics * one or more of the following five signs: severe chest in-drawing, axillary temperature \>38.0c or \<35.50 c, movement only when stimulated, and history of feeding problems (confirmed by poor suck on feeding assessment) * family refuses recommended hospitalization or hospitalization otherwise not feasible * informed consent by a legal guardian. * exclusion criteria: very severe infection/disease characterized by presence of any of the following signs (unconscious, convulsions, unable to feed, apnea, unable to cry, cyanosis, bulging fontanel, prolonged capillary refill, major congenital malformations, major bleeding, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour) * very low birth weight: weight \<1500 * hospitalization for illness in the last two weeks * previous inclusion in the study

Keywords: infant newborn sepsis infection community
rbt-1 phase 1b clinical trial in healthy volunteers and subjects with ckd

Conditions: Acute Kidney Injury

Summary: a phase 1b study to evaluate the safety, tolerability and pharmacodynamic effect of rbt-1 in healthy volunteers and subjects with stage 3b-4 ckd.

this is a phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, and pharmacodynamic effect of rbt-1 in healthy volunteers and in subjects with stage 3b-4 ckd. the following biomarkers will be used as surrogate measures of protective activity: haptoglobin, ferritin, bilirubin, hemopexin, il-10, and heme oxygenase-1. additionally, the p21 biomarker will be monitored at various points of the study.

Eligibility criteria:
inclusion criteria: 1. male and female subjects age 18 to 80 years (inclusive, at time of icf). 2. body weight \<125 kg. 3. able and willing to comply with all study procedures. 4. female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until 28 days after study drug administration. male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 28 days after study drug administration. all fertile men with female partners of childbearing potential should be instructed to contact the investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation. 5. ckd as determined by estimated glomerular filtration rate (gfr) between 15-45 ml/min as estimated using the ckd-epi equation (ckd class 3b-4). - exclusion criteria: 1. history of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers. 2. use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer. 3. serum ferritin \> 500 ng/ml or who have received iv iron within 28 days of screening, or currently being treated with oral iron. 4. women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 5. regular use of drugs of abuse and/or positive findings on urinary drug screening. 6. current tobacco use and/or positive findings on urinary cotinine screening. 7. subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol. 8. presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated. 9. known hypersensitivity or previous anaphylaxis to rbt-1 or to components thereof. -