Kornimate/medical-research-clean huggingface dataset:
stem cell transplantation for children affected with osteopetrosis

Conditions: Osteopetrosis

Summary: malignant infantile osteopetrosis (miop) is a rare fatal genetic disorder that is characterized by the bone's inability to regulate remodeling. the only curative therapy is hematopoietic stem cell transplantation. stem cells provided from an hla identical matched sibling donor is the standard of care, but not feasible for the majority of patients. in addition, due to the potentially rapid progression of this disease, the time to identify a suitable hla matched unrelated donor is not optimal. therefore this study is designed to test the hypothesis that children with osteopetrosis can properly engraft hematopoietic stem cells that are donated from a partially matched parental donor, or "haploidentical" stem cell donor that are processed on the investigational device, clinimacs selection system.

the primary objective of this trial will be answered strictly by those patients enrolled who receive a haploidentical stem cell donor graft. patients with a matched sibling donor will be offered participation in this clinical trial and will receive a standard myeloablative conditioning regimen followed by the infusion of an unmanipulated bone marrow graft. however, data from these transplant recipients will be reported in a descriptive manner only. secondary objectives in this trial include the following: * to describe the outcome of children with miop who receive hematopoietic stem cells from a matched sibling donor or a haploidentical donor utilizing a uniform approach one year from transplant * to estimate the fraction of children with miop who have a genetic defect correlating to the osteopetrosis phenotype * to assess carrier-state of the genetic mutation in parents with an affected child * to assess carrier-state of the genetic mutation in siblings of affected children * to estimate the effect of age at the time of hematopoietic stem cell transplantation on the overall outcome of children with miop * to describe the kinetics of select cytokine expression before and after transplantation

Eligibility criteria:
inclusion criteria: * clinical diagnosis of malignant osteopetrosis as documented by bone marrow biopsy and radiographic imaging * a suitable hematopoietic stem cell donor is available exclusion criteria: * participant has the carbonic anhydrase ii (caii) deficiency osteopetrosis variant * symptomatic cardiac disease or evidence of significant cardiac dysfunction by echo (shortening fraction \<30%) * creatinine clearance ≤ 40ml/min/1.73m\^2 * bilirubin ≥ 3mg/dl * sgpt ≥ 500 u/l * evidence of current severe infection which would preclude ablative chemotherapy or a successful transplantation * karnofsky or lansky score \< 70 noting expected abnormalities

Keywords: osteopetrosis autosomal recessive bone disease haploidentical stem cell transplantation allogeneic stem cell transplantation t-cell depletion methodology miltenyi biotec clinimacs stem cell selection device
management of participants with low-level persistent viremia (anrs 161 l-vir)

Conditions: HIV-1 Infection; Treatment Resistant Disorders; Viremia

Summary: management of participants with low-level persistent viremia

anrs 161 l-vir is a phase iii prospective, randomized, multicenter, open-label, superiority trial for participants with low-level persistent viremia. participants will be randomized with a 1:1:1 ratio to the following three arms, * reference arm : counseling without antiretroviral treatment modification * switch arm : switch of current pi/r for prezista® (darunavir)/ norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (bid) with counseling. * addition of isentress® (raltégravir) arm : isentress® (raltegravir) 400 mg two times a day (bid) added to current antiretroviral treatment with counseling

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hiv-1 infection * on combined antiretroviral regimen for at least 18 months * participant with a stable antiretroviral regimen for at least 6 months, including 2 reverse-transcriptase inhibitor (inti) + 1 boosted protease inhibitor ip/r , * participant with at least 2 consecutive viral load between 50 and 500 copies/milliliter over the last 9 months (with at least 2 months between the two measurements) quantified with the same commercial kit. * 50 \<or= vl \< 500 copies/milliliter at screening visit quantified with the same commercial kit than previous one. * participant naïve to raltegravir (ral) * failure of amplification or successful realization of genotypic resistance test without evidence for resistance mutations against current treatment (3tc/ftc accepted with m184v mutation) * creatinin \< 3 upper limit normal (uln) * aspartate amino transférase (asat), alanine amino transférase (alat) \< 5 upper limit normal (uln) * hemoglobin \> 8 g/dl * platelets \> 50 000/mm3 * in women, lack of current pregnancy verified by beta human chorionic gonadotropin (βhcg) at week -4 visit and use of a mechanical contraceptive method * informed consent * participants with an active health insurance coverage (article l1121-11 du code de la santé publique) exclusion criteria: * hiv-2 infection, * severe medical condition in the last month (inclusion is possible for a stable condition at screening) * breastfeeding women, current pregnancy or planned pregnancy within 12 months. * participant currently receiving prezista® (darunavir)/ norvir® (ritonavir) (600/100 mg) two times a day (bid) (of note, participants receiving prezista® (darunavir)/ norvir® (ritonavir) one time a day (qd) can be included) * hypersensitivity prezista® (darunavir)/ norvir® (ritonavir) or to any of the excipients of the study treatment * participant under judicial protection (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship * planned absence that could prevent the patient from participating in the trial (travel abroad, moving, pending work transfer ...)

Keywords: hiv-1 antiretroviral treatment viral load
iprep study #2: evaluating enhanced prep packages for young female sex workers in kisumu, kenya

Conditions: HIV

Summary: this is an open-label randomized controlled trial (n=200) in which hiv-negative young female sex workers (fsw) will be randomized to receive oral prep combined with specific behavioral and structural adherence interventions, either: (1) intensive peer support (ps) or (2) reminders and resource transfer (rrt).respondent-driven sampling (rds) will be used to recruit fsw as potential study participants.the study adherence interventions will be delivered over the first 12-month period in conjunction with prep. thereafter, the study-specific adherence interventions will be withdrawn and prep continued for an additional 12 months with standard support as per national guidelines. trial participants will be followed for a total of 24 months and attend 11 study visits over this period.

the overall aim of the proposed study is to compare the effectiveness, feasibility and acceptability of two adherence support interventions, peer support (ps) and reminders plus resource transfer (rrt), in combination with daily oral pre-exposure prophylaxis (prep) to optimize prep adherence among young in kisumu, kenya. pre-exposure prophylaxis (prep) is a promising biomedical hiv prevention intervention. findings from placebo-controlled efficacy trials highlight the need for adherence support to achieve prep efficacy and public health impact.

Eligibility criteria:
inclusion criteria: * report no previous diagnosis of hiv infection * report being a cisgender female or transgender female * report being between 18-24 years of age * report living or working in study area * report intention to stay in study area for 24 months * report exchange sex with men for goods, money, favors or other services in past 3 months * report no previous or recent (within the last 3 months) prep use * able to complete study procedures in english, kiswahili or dholuo * willingness to be randomized and adhere to study interventions according to eligibility, including prep exclusion criteria: * ineligible for prep according to guidelines on use of antiretroviral drugs for treating and preventing hiv infection in kenya - 2018 edition (national aids and sti control program, 2018) * unable to provide informed consent for study procedures * any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the principle investigators, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. * reports plan to leave area in the next 24 months

Keywords: pre-exposure prophylaxis (prep) hiv prevention adherence
non invasive arrhythmia detection in hospital settings

Conditions: Arrhythmias

Summary: this is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.

the system will continuously monitor the patient's cardiac activity which will be compared to standard telemetry system.

Eligibility criteria:
inclusion criteria: * is female or male, 18 years of age or older * undergoing icd implant with ventricular arrhythmia induction or undergoing ep study with ventricular arrhythmia induction exclusion criteria: * is participating in another clinical study that may confound the results of this study
potentiation of procedural motor learning in health and disease

Conditions: Stroke

Summary: the investigators plan to improve the learning of motor skills by pharmacological means (dopamine), and by noninvasive brain stimulation. they will study both healthy subjects and chronic stroke patients. in addition, they want to study the mechanisms of enhanced learning, on the molecular and the systems level.

adaptive behavior requires procedural motor learning, i.e. the acquisition of motor skills. procedural learning is particularly critical in the rehabilitation of chronic motor deficits after stroke. a potent modulator of motor function and learning is found in the endogenous dopaminergic system. the investigator's own work could demonstrate that formation of an elementary motor memory, which constitutes the first step in acquiring more complex motor skills, can be enhanced in both healthy subjects and chronic stroke patients by pre-medication with levodopa. the aim of the present proposal is to: * expand these exciting findings to procedural motor learning; * explore the interaction with age, brain lesions, add-on interventions such as transcranial direct current stimulation (tdcs); and * illuminate the underlying mechanisms. the effect of levodopa +/- tdcs on procedural motor learning and cortical excitability will be studied in healthy volunteers and stroke patients. then the investigator plans to delineate the underlying mechanisms of this effect by exploring n-methyl-d-asparate (nmda) receptor-dependency of levodopa-enhanced learning and changes in activation and connectivity (using functional magnetic resonance imaging) in the respective neural networks resulting from the interaction of learning and dopaminergic neuromodulation.

Eligibility criteria:
inclusion criteria: healthy volunteers: * normal neurological examination * mini mental state examination of \> 27 * right handedness stroke patients: * cortical or subcortical stroke with an initial severe hemiparesis medical research council (mrc) scale \ mrc 4.5, with low spasticity, work in progress on motor learning in stroke patients) * at least 1 year post-stroke * mini mental state examination of \> 27 * right-handedness exclusion criteria: healthy volunteers and stroke patients: * no antipsychotic, antidepressant drugs, and drugs affecting the dopaminergic system.

Keywords: dopamine nmda receptor brain imaging neuroplasticity learning transcranial direct current stimulation rehabilitation aging
safety of escalating doses of intravenous bone marrow-derived mesenchymal stem cells in patients with a new ischemic stroke

Conditions: Ischemic Stroke

Summary: stroke is a major cause of adult disability. currently approved reperfusion therapies are provided to only a small percentage of patients in the u.s. new therapies are needed that improve outcome and that can be accessed by a majority of patients. animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. a large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. the current study aims to assess the safety of this therapy in patients with recent ischemic stroke.


Eligibility criteria:
inclusion criteria: * 1. ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated, radiologically confirmed, and with either diameter \>15 mm or volume \> 4cc. * 2. the index stroke has clinical deficits that are moderate-severe (nihss score 7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring, and was not associated with a concomitant stelevation myocardial infarction. * 3. age 18-80 years, inclusive * 4. reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy. exclusion criteria: * 1. no substantial pre-stroke disability (pre-stroke modified rankin scale score 0-2). * 2. females of child-bearing potential will be excluded unless (1) a negative urine pregnancy test is obtained and (2) the patient has been effectively using contraceptive method with known failure rate \<1 % for at least 90 days. * 3. lactating mothers * 4. if thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion. * 5. known allergy to penicillin or to fetal bovine serum * 6. active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse. * 7. any diagnosis that makes survival to 1-year post-stroke unlikely. * 8. participation in any other experimental therapeutic clinical trial concurrently or in the prior three months. * 9. contraindication to undergoing mri scanning.
ceftobiprole in the treatment of patients with community-acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to compare the clinical cure rate (ratio of clinically cured patients to the total number of patients) of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia.

ceftobiprole medocaril is a cephalosporin antibiotic with anti-mrsa (methicillin-resistant staphylococcus aureus) activity. ceftobiprole medocaril is not yet approved for the treatment of community-acquired pneumonia. this is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with community-acquired pneumonia. the patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. patients who meet specified criteria may be switched to an alternative oral treatment. the primary endpoint is that the clinical cure rate among patients treated with ceftobiprole at the test of cure visit. the patients will receive either ceftobiprole medocaril plus placebo or a comparator.

Eligibility criteria:
inclusion criteria: * patients suffering from community-acquired pneumonia severe enough to require hospitalization * female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study exclusion criteria: * patients with known or suspected hypersensitivity to any related antibiotic medications * treatment with any experimental drug within 30 days before enrollment * prior enrollment in this study or any study with ceftobiprole medocaril

Keywords: community-acquired pneumonia cephalosporins methicillin-resistant staphylococcus aureus
smoking cessation intervention in respiratory inpatients

Conditions: Pulmonary Disease, Chronic Obstructive; Asthma; Community Acquired Pneumonia

Summary: prospective, open-label, parallel-group, 52-week trial comparing varenicline in combination with behavioral support with one session of behavioral support alone. eligible patients were smokers hospitalized due to a) acute exacerbation of chronic obstructive pulmonary disease (copd), or b) bronchial asthma attack, or c) community-acquired pneumonia (cap). the primary outcome was the success rate (%) at week 52. secondary outcomes were quality of life (qol) alterations on the domains of the 36-item short form health survey (sf36) and investigation of possible predictors for smoking abstinence.

patients screened for eligibility were all the smokers who were hospitalized in the first pulmonology clinic of kavala general hospital from may 2012 to may 2014. patients had an initial private consultation session and motivational interview while still in the hospital. following this interview, patients chose the smoking cessation intervention they preferred: either the standard regimen for varenicline and behavioral support or behavioral support without pharmacotherapy. all patients quit smoking while still hospitalized.follow-up phone calls with a minimum duration of 10 minutes were scheduled in weeks 1, 2, 4, and months 3,6 and 9 following smoking cessation. patients in both groups were asked to return to hospital in month 12 (week 52) for a final assessment. at this last visit, the sf36 was again completed and exhaled co was (re) measured.

Eligibility criteria:
inclusion criteria: * adult smokers (\> 100 cigarettes in their lifetime) * patients hospitalized due to either a) acute exacerbation of copd, or b) acute exacerbation of bronchial asthma, or c) community acquired pneumonia. * patients who agreed to participate and provided written informed consent were recruited. exclusion criteria: * inpatients younger than 18 * adult smokers hospitalized for any reason other than acute exacerbation of copd / bronchial asthma or community acquired pneumonia.

Keywords: varenicline copd asthma pneumonia smoking cessation
effect of acetaminophen preemptive analgesia on postoperative cognitive function

Conditions: Cognitive Function

Summary: patients undergoing gastrointestinal tumor surgery are prone to delayed recovery and postoperative cognitive dysfunction due to greater trauma and longer operation time. pre-analgesia can reverse the effects of nociceptive stimulation on recovery from general anesthesia and postoperative cognitive function. intravenous injection of non-steroidal drugs can effectively reduce postoperative pain and the use of opioids. therefore, this study selected acetaminophen mannitol injection for preemptive analgesia to observe the effects on anesthesia recovery time and postoperative cognitive function of patients undergoing gastrointestinal tumor surgery, providing new ideas for reducing cognitive dysfunction in patients undergoing gastrointestinal tumor surgery

by administering acetaminophen to patients with gastrointestinal tumors before surgery, recording the time to recovery from anesthesia, and assessing cognitive function status by cam on the first, third, and seventh day after surgery

Eligibility criteria:
inclusion criteria: * patients undergoing gastrointestinal tumor surgery * american society of anesthesiologists（asa）≤ⅲ exclusion criteria: * history of severe adverse reactions to oral acetaminophen * dysfunction of heart, liver, kidney and other important organs * history of chronic pain * oral non-steroidal or opioid drugs * patients who do not accept clinical trials

Keywords: acetaminophen mannitol cognitive function anesthesia recovery time gastrointestinal tumor surgery
evaluation of the performance of non-molded soft contact lenses

Conditions: Ametropia

Summary: to evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.

to evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.

Eligibility criteria:
inclusion criteria: * male or female, good health, age \>17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood \& signed consent form. exclusion criteria: * has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
intravesical antimicrobial agents v standard oral antibiotics for the treatment of acute uti in women with ruti

Conditions: Urinary Tract Infections

Summary: women have problems with oral antibiotics, including vagina and bowel infections. also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.

each participant once enrolled returns with an active urinary tract infection (uti), confirmed by urine void. participants will complete an uti questionnaire, and if consistent with a simple non-febrile uti will be randomized to one of two arms: oral nitrofurantoin treatment for 7 days, or intravesical gentamicin instillation once a day for three days. patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and with a repeated questionnaire for symptom relief.

Eligibility criteria:
inclusion criteria: * ability to understand study procedures and to comply with them for the entire length of the study. exclusion criteria: * patients who report that they are pregnant. * patients with a positive urine pregnancy test * patients with a history of renal transplantation. * patients with bladder augmentation procedures using bowel. * patients with poorly controlled type ii diabetes, hgb a1c \>6.5% * patients with spinal cord injury, asia impairment scale of c or higher. * patients with pelvic surgery within 6 months. * patients with urologic procedure within 6 months. * patients with a history of reconstructive urologic surgery, such as reflux, congenital abnormality. * immunocompromised patients being treated for malignancy or a history of actively treated malignancy within 5 years. * patients with active systemic autoimmune disease. * patients on systemic immunosuppression. * use of antibiotic prophylaxis within 6 months * use of antibiotics within 10 days of active infection * allergy/sensitivity to gentamicin or nitrofurantoin. * current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * inability or unwillingness of individual to give written informed consent.

Keywords: urinary tract infection recurrent women