Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effect of nandrolone decanoate in women with hiv-associated weight loss

Conditions: HIV Infections; HIV Wasting Syndrome

Summary: the purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in hiv-positive women who have hiv-associated weight loss (wasting). wasting has become an aids-defining condition. in the past, most studies that examined wasting treatments were limited to men. however, it appears that wasting in hiv-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). this study has been designed for women only, in order to best treat wasting in hiv-positive women.

body wasting is an increasingly frequent aids-defining condition and it is becoming evident that women are not exempt from this complication of hiv. although multicenter trials of megestrol acetate, dronabinol and growth hormone have not specifically excluded women, women have generally been underrepresented in these trials. this study hopes to generate data that will be substantial enough to perform an analysis that might determine whether there are gender-based differences in anabolic potential. patients will be randomized to receive either nandrolone decanoate or placebo every 2 weeks for 12 weeks of the study. all patients who complete the first 12 weeks of the study will be eligible to receive open-label nandrolone for the subsequent 12 weeks.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are an hiv-positive woman over 13 years old (need consent if under 18). * have lost weight over the past 12 months. * are able to eat almost enough to maintain your current weight. * agree to practice abstinence or use effective methods of birth control. * are on a stable anti-hiv drug regimen or have not been on any anti-hiv drug regimen for the past 30 days. exclusion criteria you will not be eligible for this study if you: * are allergic to nandrolone. * have a history of cervical cancer, diabetes, cardiomyopathy or congestive heart failure, or are taking certain medications. * have an active opportunistic (hiv-associated) infection or another major illness within 30 days of study entry. * have an abnormal pap smear. * have difficulty eating (are on tube-feeding, for example). * have severe nausea, vomiting, or diarrhea. * have kaposi's sarcoma (unless stable) or are receiving chemotherapy or radiation for any type of cancer. * are pregnant or breast-feeding.

Keywords: placebos acquired immunodeficiency syndrome aids-related complex anabolic steroids hiv wasting syndrome nandrolone decanoate
dose ranging study for indacaterol in japanese asthma patients

Conditions: Asthma

Summary: this study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies.


Eligibility criteria:
inclusion criteria: * male and female japanese asthmatic patients aged 18 to 75 years old. exclusion criteria: * patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to the first day of screening or during the screening period. * patients who have used tobacco products within 6 months prior to the first day of screening or have a smoking history of greater than 10 pack years. * patients with a history of malignancy with the exception of localized basal cell carcinoma of the skin. * pregnant or nursing (lactating) women. * patients who have had treatment with disallowed medications including investigational drug. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: asthma qab149 indacaterol long acting β2-agonist bronchodilator
usability of the smart hallway system in clinical setting

Conditions: Amputation; Gait Disorders, Neurologic

Summary: the aim of the study is to examine suitability of data and processed reports acquired from the smart hallway system for clinical settings in terms of user acceptability and accuracy for use in clinical practice.

the goal of the study is to use off-the-shelves markerless and contactless technologies and automatically digitise the person's movements as they walk through an institutional hallway. multi-camera-based technologies can merge 2d-video into 3d-information. with an appropriate software, one can acquire data, perform the kinematic calculations and generate a report, all with minimal or no human intervention. the specific research question are whether pathological gait or walking disorders of the patients can be identified and classified based on the system's output, whether signs of depression can be classified from the the system's output, and whether the results of the 6-minute walk test can be predicted from the the system's output.

Eligibility criteria:
inclusion criteria: * ability to walk at least 10 metres without help of a person, * no severe cognitive problems (able to answer questionnaires), * native slovenian speakers, * wiling to participate (signed informed consent) exclusion criteria: * severe cognitive impairment, * not being able to walk with or without a prosthesis or orthosis.

Keywords: gait analysis computerised assessment rehabilitation lower limb loss prosthetics and orthotics
adverse events in pharmaceutical bioequivalence study of two formulations of metformine hydrochloride 500 mg

Conditions: Nutritional and Metabolic Diseases

Summary: the objective is evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.

objective: to evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events. material and methods: the study was approved by research ethics committee and all twenty-eight volunteers signed the selected ic. an open, randomized, crossover study with two periods of confinement and an interval of seven days between them was performed. twenty (20) blood collections were performed between 30 minutes and 36 hours after drug administration. plasma samples were analyzed by liquid chromatography mass spectrometry (lc-ms/ms). statistical analysis was conducted based on pharmacokinetic parameters: maximum concentration (cmax) and area under the curve (auc 0-te auc 0-inf). analysis of variance (anova) model appropriate was employed for the two periods cross under the logarithmically transformed data.

Eligibility criteria:
inclusion criteria: * within 10% of their ideal body weight * age between 18 and 50 years * healthy conditions * ability to understand the written informed consent exclusion criteria: * pregnancy * smokers * alcohol and drugs

Keywords: metformine adverse events bioequivalence
detection of pulmonary embolism with cect

Conditions: Pulmonary Embolism

Summary: to compare the vascular enhancement of the two contrast agents in pulmonary multi-detector cta


Eligibility criteria:
inclusion criteria: * patients 18 yrs or older * with suspected pe * referred for mdcta of pulmonary arteries * signed informed consent exclusion criteria: * pregnant and lactating females * history of hypersensitivity to iodinated contrast agents * hyperthyroidism or pheochromocytoma * severe chf * renal impairment * weight greater than 300 lbs * pacemaker * swan ganz catheter * defibrillator or other intrathoracic metallic vascular device * received an investigational compound within 30 days of being in the study
observational study of the value of using obstructive sleep apnea-hypopnea syndrome (cpap) ventilation on the occurrence of respiratory and cardiovascular complications in patients at high risk of obstructive apnea syndrome during postoperative sleep surgery of a major abdominal surgery.

Conditions: Major Abdominal Surgery

Summary: the presence of an obstructive sleep apnea-hypopnea syndrome (osahs) is a perfectly identified cardiovascular and metabolic risk factor responsible for excess mortality in patients with severe osahs, while life expectancy, when the sahos is treated by continuous positive airway pressure (cpap) is close to that of the general population. it also represents a factor of excess mortality, little known and poorly explored, in relation to morbidity and mortality occurring during the perioperative period accompanying any general anesthesia.


Eligibility criteria:
inclusion criteria: * patients over 18 years old and naive to any treatment with obstructive sleep apnea-hypopnea syndrome, * patients at high risk of obstructive sleep apnea-hypopnea syndrome (stop bang ≥ 3), * patients scheduled for major abdominal surgery (all intraperitoneal surgeries excluding vesicles, eventrations and hernias, all aortic surgeries excluding endovascular surgeries) within a minimum of 10 days, * it is possible to integrate the explanations concerning the realization of the apnealink ™ air in autonomy and to ensure its restitution under 24-48h, exclusion criteria: * patients with obstructive sleep apnea-hypopnea syndrome diagnosed before surgery, * patients with heart failure (nyha\> ii), * patients with moderate to severe copd * patients participating in a clinical trial,
a study of nvl-330 in patients with advanced or metastatic her2-altered nsclc (heroex-1)

Conditions: Locally Advanced Solid Tumor; Metastatic Solid Tumor

Summary: phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of nvl-330, determine the recommended phase 2 dose (rp2d), and evaluate the antitumor activity in patients with advanced or metastatic her2-altered nsclc. phase 1a dose escalation is designed to assess the safety and tolerability of nvl-330 and to select the candidate rp2d(s) and, if applicable, the mtd. phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate rp2d(s) of nvl-330 and to determine the rp2d of nvl 330 in patients with advanced or metastatic her2 mutant nsclc.

the planned phase 1a/1b first-in-human study is designed as a two-part clinical trial to investigate nvl-330 in pre-treated patients with advanced or metastatic her2-altered nsclc. the dose escalation phase of the trial is designed to enroll a set number of patients per cohort at protocol defined dose levels. after the initial patients are treated at a given dose level and monitored for at least 28 days, available data will be reviewed, and initiation of the next dosing group will proceed with consideration given to the overall safety profile. the expansion phase of the trial is designed to further evaluate safety and activity and to confirm the rp2d(s).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. histologically or cytologically confirmed locally advanced or metastatic nsclc 3. documented her2 status as follows: 1. phase 1a: documented oncogenic her2 mutation such as her2 exon20 insertion mutations or single nucleotide variants or her2 amplification. 2. phase 1b: documented oncogenic her2 mutation. 4. identification of lesions as follows: 1. phase 1a: must have evaluable disease (target or nontarget) according to recist 1.1. 2. phase 1b: must have measurable disease, defined as ≥ 1 radiologically measurable target lesion according to recist 1.1. 5. adequate organ function and bone marrow reserve exclusion criteria: 1. patient's cancer has known oncogenic driver alteration other than her2 2. known allergy/hypersensitivity to excipients of nvl-330 3. major surgery within 4 weeks of the first dose of study drug 4. ongoing or recent anticancer therapy 5. actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study
simulation efficacy in neurosurgical education

Conditions: Educational; Simulation; Hydrocephalus; Intraventricular Hemorrhage

Summary: this study aims to investigate the efficacy of simulation in neurosurgical training.

this study aims to investigate the efficacy of simulation in neurosurgical training. this will be assessed using accuracy and speed tests in the placement of external ventricle drain catheters (evds). evd placement is a relatively simple neurosurgical procedure aimed at inexperienced young trainees. this study has two arms. the recruits are inexperienced trainees and/or interns and students who have never performed evd placements before. the recruits are randomly assigned (using computer-based randomisation) to either arm a or arm b. recruits to arm a undergo simulation training (computer simulation of the procedure, followed by simulation on a dead animal model), after which the recruits will attempt to perform an evd procedure on their own, on a 3d-printed skull model that we designed. recruits to arm b will witness an evd placement as performed by an experienced surgeon, after the recruits will attempt to perform an evd procedure on their own, using the aforementioned 3d-printed skull model. this mimics the ''see one, do one'' paradigm prevalent in surgical training. the efficacy of the simulation training will be assessed using the following criteria: i. accuracy test: the accuracy of the catheter placement is assessed in both arms and compared to investigate whether there is a difference in the accuracy of the catheter placement in both arms. ii. speed test: the speed of catheter placement is assessed in both arms and compared to investigate whether there is a difference in the speed of the catheter placement in both arms. iii. subjective surveys the researchers will gauge the extent of the trainees' confidence in their surgical skills and their satisfaction with their training before and after completion of the simulation training using a questionnaire to be designed for this purpose. the trainees will assess their own familiarity with and confidence in the procedure using a scale from 0 ("not familiar with the procedure", "i have no confidence in being able to perform this procedure independently") to 10 ("i am an expert at this procedure", "i am able to perform this procedure independently with complete confidence"). this data will be collected and input into a statistical software (statistical lab v. 3, cedis) to analyse the difference (if any) in the trainees' familiarity with the procedures and their confidence in being able to perform them in both arms.

Eligibility criteria:
inclusion criteria: * never performed evd placements before exclusion criteria: * any surgical experience with evd placement

Keywords: medical education simulation neurosurgical education simulation laboratory ventricular drain
gbt021601-022: a study of gbt021601 in participants with sickle cell disease (scd)

Conditions: Sickle Cell Disease

Summary: an open-label extension study of gbt021601 in participants with sickle cell disease

an open-label extension study to evaluate the long-term safety and efficacy of gbt021601 administered to participants with sickle cell disease who have participated in a gbt021601 clinical trial

Eligibility criteria:
inclusion criteria: 1. male or female aged 6 months or older with scd who participated and received study drug or placebo in a previous osivelotor clinical study and completed the end of treatment visit. note: participants who discontinued study drug in the originating study due to an teae, but who remained on study, may be eligible for treatment in this study provided the teae does not pose a risk for treatment with osivelotor. 2. females of childbearing potential are required to have a negative urine pregnancy test prior to dosing on day 1. note: females who become of childbearing potential during the study must be willing to have negative urine pregnancy tests to remain in the study. 3. if sexually active, females of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 120 days after the last dose of study drug. if sexually active, male participants must use barrier methods of contraception until 84 days after the last dose of study drug. male participants are eligible to participate if they agree to the following requirements during the study intervention period and for 84 days after the last dose of study intervention: * refrain from donating sperm plus either * be abstinent from heterosexual intercourse as their preferred and usual lifestyle or * must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person 4. participant has provided written informed consent/assent. for underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirements. exclusion criteria: * participant withdrew consent or was noncompliant from the originating osivelotor clinical study * current or recent use of voxelotor. recent use is defined as within 10 days prior to day 1 * current or recent use of crizanlizumab. recent use is defined as within 90 days prior to day 1 * participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent * has received an investigational drug (including investigational vaccines) within 5 times the elimination half-life (if known) or within 30 days (if the elimination half-life- is unknown) prior to study drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study
abdominal aortic aneurysm sac healing and prevention of endoleaks

Conditions: Abdominal Aortic Aneurysm

Summary: to determine the safety and efficacy of impede-fx embolization plug and/or impede-fx rapid fill to fill an abdominal aortic aneurysm (aaa) sac outside of an endovascular aneurysm repair (evar) stent graft.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * a candidate for elective evar of an infrarenal aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women exclusion criteria: * an inability to provide informed consent * enrolled in another clinical study * concomitant iliac artery ectasia or aneurysm (common iliac artery diameter \>24 mm) * patent aaa sac feeding vessels (within the sac) \>4 mm in diameter * volume of aaa sac to be filled after stent graft placement \ 135 ml, based on pre-procedure cta (i.e. aortic flow volume exclusive of stent graft volume) * use of aortic stent grafts other than the gore excluder aaa endoprosthesis, cook zenith flex aaa endovascular graft, medtronic endurant ii stent graft, or endologix ovation alto abdominal stent graft system to treat the aaa * planned use of the chosen stent graft outside its instructions for use (ifu) * planned use of fenestrated or chimney stent grafts * study participants in which stent graft placement is abandoned for any reason, and/or in which the investigator decides, during the course of the stent graft placement, that the study procedure may not be appropriate * planned use of embolic devices other than the investigational product to embolize the aaa sac * vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the aaa sac * ruptured, leaking, or mycotic (infected) aneurysm * aneurysmal disease of the descending thoracic aorta * coagulopathy or uncontrolled bleeding disorder * long-term (\>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin k antagonist anticoagulant use * serum creatinine level \>2.5 mg/dl; * cerebrovascular accident within 3 months prior to the procedure * myocardial infarction and/or major heart surgery within 3 months prior to the procedure * atrial fibrillation that is not well rate controlled * unable or unwilling to comply with study follow-up requirements * life expectancy of \<2 years post-procedure * known hypersensitivity or contraindication to platinum, iridium, or polyurethane * a condition that inhibits radiographic visualization during the implantation procedure * history of allergy to contrast medium that cannot be managed medically * uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study * pregnant or a lactating female. for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study * prisoner or member of other vulnerable population.
phase 1b malaria clinical trial using argemone mexicana in healthy adults in mali

Conditions: Malaria

Summary: the main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of the decoction of the aerial parts of argemone mexicana (am), administered in healthy volunteers.

this is an open non comparative safety and pharmacokinetic (pk) study clinical trial. healthy volunteers aged from 18 to 50 years old will be recruited and followed 42 days after treatment initiation as in the current world health organization malaria drug protocol efficacy assessment protocol. each volunteer will be take oral argemone mexicana in decoction formulation. for the pk assessment purposes, 3 groups have been constituted: (i) a group will receive a unique dose of with blood withdrawal scheduled at 0 hour, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hour , 8 hours and 12 hours. (ii) a group will receive two doses (morning and evening) of argemone mexicana for 14 days with blood withdrawal scheduled at 0 hours, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 3 days, 7 days and 14 days. (iii) a group will receive two doses (morning and evening) of argemone mexicana for 14 days with blood withdrawal scheduled at 0 hour, 12 hours, 14 hours, 16 hours, 18 hours, 20 hours, 22 hours, 24 hours, 3 days, 7 days, 14 days and 21 days safety will be assessed clinically (clinical exam and electrocardiography) and biologically (hematology and biochemistry parameters will be measured) throughout the 42 days of thefollow-up.

Eligibility criteria:
inclusion criteria: * age of 18-50 years old; * be in good general health; * be available for the duration of the study; * agreement to participate in the study * be a resident of the village known study; * acceptance of the conservation laboratory specimens for future research. exclusion criteria: * plasmodium falciparum infection with clinical manifestations; * presence of severe or complicated malaria; * acute medical condition; * any other medical condition that requires medical attention inconsistent with the study or interfere with the study; * severe medical conditions; * allergy to the product of the study, * pregnant women or nursing * taking a derivative product of the study or other known antimalarial within 14 days before enrollment. * refusal to participate

Keywords: healthy volunteers pharmacokinetics malaria argemone mexicana
olanzapine versus placebo for moderately emetogenic chemotherapy

Conditions: Chemotherapy Induced Nausea and Vomiting

Summary: a study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy

a randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy

Eligibility criteria:
inclusion criteria: * histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin * age of \>18 years old exclusion criteria: * pregnancy or breast feeding * has emetic episode within 24 hours * gut obstruction * uncontrolled brain metastasis * allergy to or current use of olanzapine * concomittant moderate or high emetogenic chemotherapy on day 2-5 * total bilirubin \> 2 mg/dl or creatinine clearance \< 30 ml/min * unable to swallow drug

Keywords: olanzapine moderately emetogenic chemotherapy carboplatin irinotecan oxaliplatin