Kornimate/medical-research-clean huggingface dataset:
a renal impairment study for pf-04965842

Conditions: Renal Impairment

Summary: this study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of pf 04965842 in subjects with severe renal impairment and subjects without renal impairment (part 1) and in subjects with moderate renal impairment (part 2).

this is a phase 1 non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of pf-04965842 after a single 200 mg oral dose. subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. part 1: a total of approximately16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. after statistical evaluation of results from part 1, part 2 may be conducted and approximately 8 subjects with moderate renal impairment will be enrolled. the total duration of participation from the screening visit to day 4 will be a maximum of 31 days and from the screening visit to follow-up contact/visit will be a maximum of 67 days.

Eligibility criteria:
inclusion criteria: * breath alcohol test at screening and day -1 must be negative. * body mass index (bmi) of ≥ 17.5 to ≤ 40.0 kg/m2; and a total body weight \>50 kg (110 lb). additional inclusion criteria for subjects with renal impairment: * meet the following egfr criteria during the screening period based on the mdrd equation: * severe renal impairment: egfr \<30 ml/min, but not requiring hemodialysis. * moderate renal impairment (part 2 only): egfr ≥30 ml/min and \<60 ml/min. * any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included). * stable concomitant drug regimen. exclusion criteria: * renal transplant recipients. * urinary incontinence without catheterization. * subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the investigator), evidence of any infection (including influenza) within the past 7 days prior to baseline, history of disseminated herpes simplex infection or recurrent or disseminated herpes zoster. * subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. * history of or current positive results for human immunodeficiency virus, hepatitis b, hepatitis c. additional exclusion criteria for subjects with renal impairment: * subjects requiring hemodialysis and peritoneal dialysis. * screening bp ≥ 180 mm hg (systolic) or ≥ 110 mm hg (diastolic). * screening supine 12-lead ecg demonstrating qtcf \>470 msec or a qrs interval \>120 msec.
evaluate safety of adipose derived mesenchymal stem cell transplantation for type 1 diabetes treatment

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to evaluate the safety of intravenously (iv) administered adipose-derived mesenchymal stem cell (ad-msc) in patients with type 1 diabetes mellitus (t1d)

adipose derived mesenchymal stem cells (ad-mscs) has many advantages, i.e. the greater ease of access and harvesting by means such as subcutaneous lipoaspiration, a much less painful procedure than harvesting bone marrow stem cells, and a much less ethical concern because they are harvested from autologous fat. the purpose of this study is to evaluate the safety of intravenously (iv) administered adipose-derived mesenchymal stem cell (ad-msc) in treatment 10 patients with type 1 diabetes mellitus (t1d) at vinmec international hospital, hanoi, vietnam.

Eligibility criteria:
inclusion criteria: * patient diagnosed t1d (according to the instructions of the ministry of health no: 5481/qd-byt dated december 30, 2020) * aged from 5 years and over. * the time from the diagnosis of type 1 diabetes to enrollment ≤ 12 months. * blood testing conducted at the time of diagnosis: * fasting blood glucose ≥ 7 mmol / l, * hba1c ≥ 6.5%. * have at least one antibodies associated with t1d such as ica; gad; znt8 or iaa. * at the time of screening at vinmec for study enrollment, patients are actively managing their blood glucose levels with insulin. * the patient does not have other serious acute illness requiring treatment * the patient agrees to use stem cell transplant for treatment * the patient's parent (parent or legal guardian) can read, write, understand the icf form and agree to sign a consent to participate in the study. exclusion criteria: * having evidence related to renal dysfunction: creatinine \> 1.5 mg/dl or (\>133 mmol/l) for boys, creatinine \> 1.4 mg/dl or (\>124 mmol/l) for girls * in case of kidney failure. proteinuria within the range of nephrotic syndrome (\>3.5 g/day or ratio of protein/creatinine in urine \>2.7) * in case of kidney failure * having severe infection or infected with hepatitis b virus, hepatitis c virus, hiv virus, or tuberculosis * cardiovascular disease, respiratory disease (pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer or neurological disease * blood clotting disorders (inr\> 1,5, ptt\> 40, pt\> 15). * taking any anticoagulant * taking systemic steroids * participate in another clinical study involving experimenting drugs and/or medical equipment * history of allergic reaction to anesthetic agents and/or antibiotics

Keywords: diabetes adipose-derived mesenchymal stem cell
role of lung ultrasound imaging for intraoperative monitoring of atelectasis during laparoscopic surgery

Conditions: Atelectasis

Summary: general anesthesia results in the development of atelectasis in the dependent areas of the lungs exposing patients to an increased risk of hypoxemia. during laparoscopic procedures, pneumoperitoneum increases already present atelectasis. several methods have been suggested to reduce the impact of atelectasis during surgery. however, few intraoperative modalities for the diagnosis and monitoring of atelectasis are available. lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting. this observational study will aim to clarify the role of lung ultrasound imaging during laparoscopic surgery for the diagnostic and monitoring of atelectasis. this study is designed to: * demonstrate a link between the lung ultrasound aeration score, the partial pressure of oxygen in arterial blood (pao2) / fraction of inspired oxygen (fio2) ratio and the oxygenation index. * in the event of intraoperative desaturation, study the impact of positive end-expiratory pressure (peep) and/or increase of fio2 on the aeration score. * study the impact of pain on diaphragmatic function and the aeration score. our hypothesis is that lung ultrasound imaging allows detection of lung aeration changes associated with induction of general anesthesia, pneumoperitoneum, emergence from anesthesia and changes occurring during the stay in the recovery room.

on arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination. the anesthetic technique and monitoring will be standardized. the radial artery will be cannulated after induction of anesthesia for blood gas monitoring. lung ultrasound examinations will be performed 5 minutes following induction of general anesthesia and 5 minutes after insufflation of the abdomen with carbon dioxide. in the event of a desaturation needing an intervention (increase of fio2 or peep), ultrasound imaging will be repeated before and after the intervention. presence of a pneumothorax or endobronchial intubation will be assessed during each examination. fifteen minutes after arrival and immediately before discharge from the recovery room, lung ultrasound examinations will also be performed. fio2 and vital signs will be recorded at each ultrasound examination. arterial blood samples will be collected simultaneously. pain rating using the visual analog scale and diaphragmatic function will be assessed during the preoperative ultrasound examination and before discharge from the recovery room.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older * scheduled for laparoscopic surgery * physical status 1-3 exclusion criteria: * previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy) * contraindication to the placement of an arterial line * very severe chronic obstructive pulmonary disease

Keywords: atelectasis pneumoperitoneum hypoxemia
virtual reality experience in first trimester d&c

Conditions: First Trimester Abortion; Virtual Reality

Summary: virtual reality (vr) has been used in health care settings to decrease anxiety and pain. this project is a feasibility study to evaluate whether virtual reality can be used in the setting of a first trimester pregnancy termination by d\&c and whether the use of virtual reality (vr) headsets can help decrease anxiety for patients during this procedure.

the investigators will assess the practicality and qualitative experience of women using vr during first trimester surgical abortion under local anesthesia. semi-structured interviews will be conducted to understand the patient's experience of using vr. surveys evaluating anxiety will be administered to women before and after surgical abortion. investigators plan to enroll 30 patients in order to obtain an effect size for future studies. a group of control patients will be enrolled; these patients will receive standard care and will be compared to the anxiety scores of the group receiving vr. the mean and standard deviation of anxiety scores for each group will be used to calculate power for future studies.

Eligibility criteria:
inclusion criteria: * age 18 or over * elective surgical abortion under local anesthesia * english speaker exclusion criteria: * no psychiatric history * no history of motion sickness or vertigo * no history of seizures or epilepsy * no recent eye surgery or visual impairment * no claustrophobia. * no current nausea or vomiting * not on seizure-threshold lowering medications

Keywords: virtual reality anxiety
transcranial direct current stimulation in patients with disorders of consciousness

Conditions: Disorder of Consciousness

Summary: to date, several studies have focused on the use of transcranial direct current stimulation(tdcs) in patients with impaired consciousness.however,its therapeutic effects have been variously documented.so,in this study ,investigators explore the effects of tdcs.

background:tdcs was supposed as an experimental approach to disorders of consciousness treatment. its therapeutic effects have been variously documented. objective: the study aimed to investigate the reactivity of electroencephalography (eeg) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of highfrequency tdcs in doc. method:in this double-blind, randomized controlled trial,real or sham tdcs were applied to the left dorsolateral prefrontal (dlpf) cortex of participants with disorders of consciousness for two weeeks. evaluations were blindly performed at baseline, immediately after the end of the 14-days treatment and 1 week later with the jfk coma recovery scale-revised (crs-r) scale and eeg.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of doc 2. ages 14 to 65 years old 3. no centrally acting drugs 4. no neuromuscular function blockers and no sedation within the prior 24 hours; exclusion criteria: 1. history with nervous or spirit disorders, or some other serious diseases 2. a contraindication for tdcs

Keywords: tdcs eeg
treatment resistant depression and obstructive sleep apnea, effect of continuous positive airway pressure (cpap)

Conditions: Depression; Sleep Apnea, Obstructive

Summary: the purpose of the study is to determine the effect on mood and anxiety symptoms of adding cpap to the psychiatric treatment of patients with trd (treatment resistant depression) and associated osa (obstructive sleep apnea).

primary objective: what is the effect on mood and anxiety symptoms of adding cpap to the psychiatric treatment of patients with trd and associated osa? secondary objectives: 1. how common is co-morbid osa in patients with treatment resistant unipolar depression referred to a tertiary mood disorders clinic? 2. is there a difference in daytime functioning (severity of depressive and anxiety symptoms, cognitive function, daytime sleepiness) and sleep quality between patients with trd diagnosed with osa compared with patients with trd who have no osa? 3. what is the association between sleep fragmentation and hypoxemia and the severity of depression in patients with trd?

Eligibility criteria:
inclusion criteria: * patients with trd. * males and females between the ages of 18 and 65 years who agree to take part and sign the informed consent will be invited to participate in the study. * patients with co-morbid dysthymic disorder, generalized anxiety disorder or social anxiety disorder may be included in the study. exclusion criteria: * patients with uncontrolled medical illnesses will not be permitted to participate. * patients with a history of current or bipolar disorder, schizophrenia, panic disorder, obsessive-compulsive disorder or anorexia nervosa. * head injury patients resulting in loss of consciousness for more than 10 minutes. * patients with epilepsy or severe personality disorders who, at the judgment of the investigators, are not appropriate candidates for the study, will be excluded. * patients who do not have the mental or physical capacity to apply the cpap interface and to plug in and switch on an auto cpap unit at home will be excluded. * blind and/or deaf patients will be excluded. * patients who initially decline an offer of cpap treatment for osa, and those who prefer conservative treatment options (weight loss, avoidance of alcohol and sedatives) will be excluded. * patients with severe claustrophobia, who cannot tolerate any cpap interface, will be excluded.

Keywords: depression cpap obstructive sleep apnea
pharmacokinetic (pk) study of oxynorm injections in chinese patient

Conditions: Pain

Summary: this is a single center, open label, randomized, parallel group single dose intravenous (i.v.) administration study. the subjects will be randomized to receive a single dose of oxynorm® 2.5, 5, and 10mg.

after up to 7 days screening period, eligible patients will be randomized to 1 of 3 groups, and begin treatment with single dose of oxynorm® 2.5,5, and 10mg.

Eligibility criteria:
inclusion criteria: * patients with tumor pain / postoperative pain, or subjects with pain caused by other diseases; * patients aged \>30 to ≤ 60 years; * body weight ≥ 45kg, and bmi range ≥19, \<24; * karnofsky score ≥ 70; * expected survival is above 3 months; * the results of liver function and kidney tests must meet the following criteria:alt、ast is within the upper limit of normal value ranges by a factor 2, and tb、bun、cr is within the upper limit of normal value ranges by a factor 1.25; * the electrocardiogram examination results are normal; * patients must have given a written informed consent prior to this trial, and have the capability to complete every required test. exclusion criteria: * have hypersensitivity history to any opioids; * have known hypersensitivity to any of compositions of the study drugs; * patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region； * patients with respiratory depression, cor pulmonary, or chronic bronchial asthma; * patient unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal; * patients with hypercarbia; * patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency; * patients with alcoholism or drug abuse history; * positive ant-hiv or syphilis antibody test result; * urine screening before study is positive for the opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids; * donated 400 ml or more of blood or blood products within 3 months prior to the start of the study, or donated 200 ml or more of blood or blood products within one month prior to the start of the study. * subjects who participated in a clinical research study within two months of study entry. * patients who are currently taking opioids.
effects of treatments for anemia and iron deficiency on the electrolyte balance in lung transplant recipients: a special focus on hypophosphatemia

Conditions: Hypophosphatemia

Summary: the aim of this study is to generate evidence regarding hypophosphatemia after iron infusion in lung transplant recipients in context of anemia and/or iron deficiency.


Eligibility criteria:
inclusion criteria: * lung transplant recipient * treated at the university hospital zurich between 2015 until 2022 exclusion criteria: * denied general consent
home fortification of complementary foods in bihar india

Conditions: Anemia; Malnutrition

Summary: this study evaluates the program effectiveness of home fortification along with infant and young child feeding (iycf) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the integrated family health initiative being implemented by care india (a non-profit organization) in partnership with the government of bihar. the study also seeks to assess the field level worker experience with counseling and dissemination of home fortification products.

this study evaluates the program effectiveness of home fortification along with infant and young child feeding (iycf) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the integrated family health initiative being implemented by care india (a non-profit organization) in partnership with the government of bihar.the key objectives of this study are to examine acceptability and utilization by target population, assess impact on infant and young child feeding (iycf) practices, evaluate impact on child growth, evaluate impact on hemoglobin concentration, and assess front line worker experience and motivation to disseminate enhanced counseling and home fortification products.

Eligibility criteria:
inclusion criteria: * randomly selected children living within health-sub centers (hsc) in west champaran bihar exclusion criteria: * children less than six months of age * children greater than eighteen months of age

Keywords: vitamins public health nutrition
plasma gabapentin concentration during and following cardiac bypass

Conditions: Cardiopulmonary Bypass

Summary: this open label investigation is to determine whether cardiopulmonary bypass affects plasma gabapentin concentration after preoperative administration in the setting of cardiac bypass surgery. following signed informed consent, 16 patients scheduled for cardiac bypass surgery will be given gabapentin (600mg, oral) 1 hour prior to surgery, 1 hour following extubation and then every 8 hours for a total of 4 doses. plasma gabapentin levels will be measured prior to induction, prior to bypass, 10 min into the bypass procedure, 10 minutes before separation from bypass, 30 minutes following bypass and then before and 2 hours following each of the next 3 doses of gabapentin. pain scores, sedation scores, side effects and morphine equivalents will be documented for one day following surgery.


Eligibility criteria:
inclusion criteria: * scheduled for cardiac bypass surgery involving median sternotomy and cpb * signed informed consent exclusion criteria: * history of chronic pain * regular opioid consumption * regular anticonvulsant consumption * regular gabapentin or pregabalin use * recent congestive heart failure * ejection fraction \<35% * chronic pulmonary disease * liver disease * renal insufficiency (preoperative creatinine \> 140umol/l * history of adverse reaction to acetaminophen

Keywords: gabapentin pharmacokinetics visual analogue pain scale cardiopulmonary bypass
singing for people with aphasia

Conditions: Aphasia

Summary: to undertake a pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive rct of spa (which would assess the clinical and cost effectiveness of spa for people with aphasia)

beyond language function, people with aphasia (pwa) report a range of health problems which negatively affect wellbeing, including reduced confidence and social isolation. these psychosocial outcomes of aphasia are not sufficiently met by healthcare services: improvements in language function do not appear to lead to improvements in wellbeing. national clinical guidelines for stroke reflect this observation and highlight the need for community integration and participation of people with aphasia. this research is about singing groups for people with aphasia (spa) and is intended to address this need by focusing on the wellbeing and social participation needs of people with aphasia after stroke. the investigators engagement activities and early development project provided strong impetus for the proposed study: people with aphasia repeatedly told the investigators that singing in groups may help the participants to reconnect with society, and that this will improve wellbeing. the investigators have planned a pilot study that will allow an assessment of the extent to which the study processes and the singing groups themselves are feasible to run and are acceptable to participants. the information from this work will help the investigators to decide whether to conduct a larger randomised controlled trial (rct) which would be a fair test of whether spa can improve the lives of individuals with post stroke aphasia.

Eligibility criteria:
inclusion criteria: * diagnosis of aphasia after stroke * willingness to be randomised to either control or spa (and able to attend the singing venue) * conversational english speaker pre-morbidly * capacity to consent (assessed by recruiting team using standard tools) exclusion criteria: * \<18 years old * currently engaged in a speech or language therapy programme * intention to relocate outside the geographical region during the study * current participation in another study involving a lifestyle intervention * currently attending a singing/music group