Kornimate/medical-research-clean huggingface dataset:
effect of postoperative single dose of ketamine on pain after mastectomy

Conditions: Postoperative Pain

Summary: this is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy. the objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.


Eligibility criteria:
inclusion criteria: 1. adult women, aged 18 to 80 years old, who will undergo mastectomy. 2. willing to comply with all study procedures and be available for the duration of the study. 3. will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction 4. no distant metastases. 5. subject is american society of anesthesiologists (asa) physical status 1, 2, or 3. 6. subject is medically stable. exclusion criteria: 1. cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety. 2. past ketamine or phencyclidine misuse or abuse. 3. schizophrenia or history of psychosis. 4. known sensitivity or allergy to ketamine. 5. liver or renal insufficiency. 6. history of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated 7. pregnancy or nursing women 8. bmi\>35. 9. currently participating in another pain interventional trial. 10. unwillingness to give informed consent. 11. non-english speaking patients as qor-15 and bcpq have not been validated in all other languages

Keywords: mastectomy
a study evaluating safety and pharmacokinetics of vx-440 in combination with tezacaftor/ivacaftor in healthy adult subjects

Conditions: Cystic Fibrosis

Summary: this study evaluated the safety and pharmacokinetics of multiple ascending doses of vx-440 in combination with tezacaftor/ivacaftor (tez/iva) (triple combination \[tc\]) administered for 13 days to healthy male and female subjects


Eligibility criteria:
inclusion criteria: * female subjects of non-childbearing potential only. * body mass index (bmi) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg. * normal pulmonary function measurements, defined as forced expiratory volume in 1 second (fev1) and forced vital capacity (fvc) both ≥80% of their predicted value at screening. exclusion criteria: * for female subjects: pregnant or nursing subjects. * glucose-6-phosphate dehydrogenase (g6pd) deficiency. * history of hemolysis. * total bilirubin level \>2 × uln at screening. other protocol defined inclusion/exclusion criteria applied.
vascular markers during ogtt in diabetics and first-degree relatives

Conditions: Diabetes Mellitus

Summary: arterial stiffness is associated with increased risk for cardiovascular disease. moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. the association between damage of endothelial glycocalyx, impaired arterial elastic properties, and cfr in diabetics and first degree relatives has not been explored. the purpose of this study is to explore the association between damage of endothelial glycocalyx, impaired arterial elastic properties, and cfr in diabetics and first-degree relatives before and after during oral glucose tolerance test (ogtt).

the investigators plan to examine 90 subjects without known diabetes a standard 75-gr oral glucose tolerance test (ogtt) will be performed. \[30 first degree relatives of diabetics with normal ogtt (relatives), 30 with normal ogtt and no family history of diabetes (normals), and 30 with abnormal ogtt (diabetics) matched for age and sex\]. plasma glucose and serum insulin levels will be measured in venous blood collected at 0, 30, 60, 90 and 120min after glucose loading. at the same time intervals, the investigators will measure: 1. the carotid to femoral pulse wave velocity (pwvc) using the complior apparatus 2. the aortic pulse wave velocity (pwva), central systolic blood pressure (csbp) and augmentation index (ai) using an oscillometric method (arteriograph,tensiomed) as markers of arterial stiffness and wave reflections 3. the coronary flow reserve (cfr) at baseline and after adenosine infusion (140 μg × kg-1 × min-1) for 3 minutes to assess coronary vasomotor function 4. the perfusion boundary region (pbr- micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using sideview darkfield imaging (microscan, glycocheck). increased pbr is considered an accurate non invasive index of reduced endothelial glycocalyx thickness. in addition, the investigators will measure free fatty acids, triglycerides, glycerol, c reactive protein (crp), transforming growth factor-b (tgf-b), lipoprotein-associated phospholipase a2, (lp-lpa2), tumor necrosis factor (tnf-a), interleukin 6 (il6) and interleukin 10 (il10) propeptide of type i procollagen, (pip), propeptide of procollagen type iii (piiinp), matrix metallopeptidases 9 and 2 (mmp 9 and 2), macrophage-colony stimulating factor ( mcsf). the investigators will measure insulin resistance a) after fasting, using homeostatic model assessment (homa) and hepatic insulin sensitivity (his) b) during oral glucose tolerance test (ogtt) using matsuda index and insulin sensitivity index (isi). the investigators will categorize patients in those with normal (\ 200mg/dl at 120min).

Eligibility criteria:
inclusion criteria: * subjects without known diabetes * first degree relatives of diabetics exclusion criteria: * coronary or valvular heart disease * congestive heart failure * peripheral vascular disease * liver or kidney failure * history of alcohol or drug abuse

Keywords: arterial stiffness endothelial glycocalyx coronary flow reserve
web-based lifestyle trial among men with prostate cancer: prostate 8

Conditions: Prostate Cancer

Summary: a randomized controlled trial of a technology-based lifestyle intervention vs. usual care among men with low-risk prostate cancer to determine the feasibility and acceptability of the intervention and the effect of the intervention on behavior change related to exercise, diet, and not smoking.

this is a pi-initiated, randomized, unblinded, clinical trial of a technology-based 3 month lifestyle intervention vs. usual care among men with low risk prostate cancer. we will recruit and consent 76 men with prostate cancer at ucsf. the subjects will be asked to complete questionnaires, 7 days accelerometer measurement, body measurements (weight, waist, hip, pulse, blood pressure) and collection of blood specimen at baseline and 3 months. subjects will be randomized into two arms (intervention group and control group). the intervention group (n=38) will have access to the lifestyle website and an activity monitor (e.g., fitbit), receive text messages, and be provided with individualized lifestyle recommendations. the control group (n=38) will have standard of care and be asked to continue with their usual lifestyle habits. they will receive access to the lifestyle website and be provided with individualized lifestyle recommendations at 3 months.

Eligibility criteria:
inclusion criteria: 1. clinical stage ≤t3a nonmetastatic prostate cancer within 5 years 2. completion of treatment ≥3 months prior to enrollment, if not on active surveillance 3. ability to walk unassisted 4. be able to speak and read english 5. ability to navigate websites and email, and have internet access 6. able to travel to ucsf for pre- and post-study blood collection exclusion criteria: 1. any contraindications to moderate or vigorous aerobic exercise 2. psychiatric condition preventing the patient from giving informed consent or adhering to the study protocol 3. reporting adherence to more than 4 of the 8 targeted lifestyle behaviors via questionnaires at screening
psychological intervention for distress during hsct

Conditions: Psychological Distress; Haematopoietic Stem Cell Transplantation; Bone Marrow Transplantation

Summary: this phase ii trial aims to evaluate a new psychological intervention to alleviate distress during haematopoietic stem cell transplantation (hsct) together with examining feasibility. hsct is a complex procedure aimed at a range of haematological and autoimmune illnesses. over 3,000 individuals undergo the procedure every year in the uk with substantial benefits. however, it is very costly, intensive, and has a range of debilitating side effects. consequently, patients often experience considerable distress, which can impede recovery. a 90-minute, group-based intervention has been developed to address this need based on psychological theory of adjustment to illness-related difficulties. it is delivered by the transplant team and involves provision of information to foster more helpful perceptions about hsct and facilitating more helpful coping with its difficulties. to evaluate the effectiveness of the intervention in alleviating distress, 60 patients about to undergo hsct at two sites (sheffield \& nottingham) will be randomly allocated into two groups. patients in the intervention group will receive the new intervention prior to transplantation together with treatment as usual (tau) while patients in the control group will receive tau alone. participants and the researcher collecting the data will be blind to the allocation. demographic and relevant clinical information will be recorded at the end of participation to ensure effectiveness of randomisation. for both groups, resilience, distress, coping, and procedure-related perceptions will be measured at four time points: (i) prior to the intervention/transplantation, (ii) day of transplant, (iii) two weeks following the transplant, and (iv) four weeks following the transplant. it is hypothesised that patients in the intervention group will experience higher resilience and lower distress compared to controls and that this difference will be mediated by procedure-related perceptions and coping. a subgroup of participants of those randomised to the group intervention will be invited to participate in a feedback interview at the end.


Eligibility criteria:
inclusion criteria: * patients referred for hsct as treatment for haematological malignancy * age of 18 years or older * sufficient command of the english language or access to suitable support to comprehend materials and participate in the group and data collection over the telephone * informed consent * permission will also be sought by the patient's consultant haematologist once clients have consented exclusion criteria: * consent withdrawn * consultant haematologist raises concern regarding participation

Keywords: distress depression anxiety stress coping illness perceptions stem cell transplantation bone marrow transplantation
autoimmune cytopenias as a sign of primary immunodeficiency.

Conditions: Cytopenia

Summary: autoimmune cytopenias resistant to treatment are among the most common clinical manifestations observed in patients with congenital alterations of the immune system, such as primary immunodeficiencies (pi). the exact contribution of immune system alterations to the pathogenesis of autoimmune cytopenias has not yet been fully elucidated. moreover, conventionally employed therapeutic strategies often fail, leading to increased healthcare costs, high morbidity, and even mortality. therefore, there is a need to establish clinical guidelines for diagnosis and to identify early biomarkers capable of identifying individuals responsive to therapy. thus, a systematic approach to the study of such pathologies will allow for the identification of early biomarkers and facilitate the development of targeted therapeutic strategies


Eligibility criteria:
inclusion criteria: * clinical and hematological diagnosis of autoimmune cytopenia additional inclusion criteria for classification into responder vs. non-responder: * for immune thrombocytopenic purpura: platelet count increase \>30,000 with at least a twofold increase from pre-treatment value * for autoimmune hemolytic anemia: hb ≥10 g/dl with an increase of at least 2 g/dl compared to baseline exclusion criteria: * transient cytopenia without confirmation of autoimmunity where frontline treatment is not necessary
a study of avastin (bevacizumab) in combination with chemotherapy in patients with endocrine tumors of the gastrointestinal tract.

Conditions: Neoplasms

Summary: this 2 arm study will assess the efficacy and safety of two systemic treatments including avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. patients with duodeno-pancreatic tumors (arm 1) will be treated with 5fu/streptozotocin iv (5fu 400mg/m2/d d1 to d5;streptozotocin 500mg/m2/d/iv d1 to d5;d1=d42) every 6 weeks, plus avastin 7.5mg/kg iv every 3 weeks. patients with gastrointestinal tract tumors (arm 2) will be treated with xeloda 1000mg/m2 po bid d1 to d14 plus avastin 7.5mg/kg iv d1=d21 every 3 weeks. the patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. the anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic endocrine tumors; * no previous anti-cancer therapy, other than surgery; * progressive metastatic disease; * \>=1 measurable lesion. exclusion criteria: * abnormal cardiac function, with history of ischemic heart disease in past 6 months and/or abnormal 12 lead ecg; * patients with known bleeding disorders; * unstable systemic disease; * chronic daily treatment with high-dose aspirin, nsaids or corticosteroids; * previous history of malignancy (other than successfully treated basal and squamous cell cancer of the skin, and/or in situ cancer of the cervix).
orphenadrine versus baclofen in treatment of muscle cramps in cirrhotic patients

Conditions: Cirrhosis

Summary: muscle cramps are commonly affects patients with cirrhosis. it adversely influences the quality of life of cirrhotic patients. treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.the effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.


Eligibility criteria:
inclusion criteria: 1. age 18-70 years 2. cirrhotic patients complaining of frequent muscle cramps (\>3 per week) for at least a month exclusion criteria: 1. patients with allergy to study drugs 2. renal impairment 3. peripheral vascular disease 4. peripheral neuropathy 5. glaucoma 6. prostatic enlargement 7. pregnancy and lactation 8. patients taking calcium channel blockers, and conjugated estrogens 9. patients taking vitamin e, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study 10. patients with alcoholic cirrhosis
caervest® - a novel endothermic hypothermic device for core body cooling. safety and efficacy testing.

Conditions: Hypothermia.

Summary: cooling the whole body to 32-34 degrees centigrade from the normal of around 37 degrees centigrade for 24 hours has been shown to be an effective way of reducing damage to brain function after return of spontaneous circulation when someone has been resuscitated from cardiac arrest. cardiac arrest is a form of heart attack where the heart stops pumping. the device is a prototype cooling vest. the investigators anticipate that this will be useful in ambulances, helicopters and emergency departments where there is a need for a portable, safe, easy-to-use, inexpensive, external, effective, readily-controlled and single-patient use device able to reduce body temperature by at least 1 degree centigrade an hour to initiate cooling. what the investigators are doing in these trials is to demonstrate that the investigators can cool people and to get the best design possible for patient use. that means some of the initial prototypes will not resemble what we expect the eventual device to look like. the investigators will be undertaking the initial trials on 30 normal volunteers.


Eligibility criteria:
inclusion criteria: human volunteers aged over 18. the upper age limit, as is standard for risk mitigation in such studies, is 35. the volunteer must have capacity to understand the trial and give informed consent to participate. if the volunteer's first language is not english we will make use of sussex interpreting services, a professional interpreting service. exclusion criteria: pregnancy. any disclosed medical condition. any medical condition detected on examination. core temperature outside stated parameters. we will ask the volunteer to confirm that they are otherwise healthy, taking no regular medication (except the oral contraceptive pill), are not using recreational drugs and have no significant past medical history, in particular cardiovascular disease of any sort, thyroid disease, diabetes mellitus or other metabolic disease.

Keywords: hypothermia, induced rewarming therapeutic heart arrest asystole frostbite
topical scalp psoriasis study evaluating topicort topical spray

Conditions: Psoriasis

Summary: a single center, study of 20 subjects to assess 4 weeks of therapy with topicort® twice daily bid and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis

all patients will receive topicort® twcie daily (bid) for 4 weeks. after week 4 patients will receive topicort® twice weekly (on consecutive days) for 12 weeks, patients will treat other body areas affected by plaque psoriasis with topicort® during the study period (excludes face, groin, axilla)

Eligibility criteria:
inclusion criteria: 1. male or female adults ≥ 18 years of age. 2. diagnosis of chronic plaque-type scalp psoriasis. 3. iga of mild or greater (scalp only) determined at screening 4. scalp surface area of 30% or greater determined at screening 5. able to give written informed consent prior to performance of any study related procedures. 6. females of childbearing potential (fcbp) must have a negative pregnancy test at screening and baseline. fcbp who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (iud); tubal ligation; or partner's vasectomy; male or female condom, diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. 7. subject must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination. exclusion criteria: 1. \<30% scalp surface area 2. scalp investigator global assessment (iga) clear or almost clear at time of screening 3. any condition, which would place the subject at unacceptable risk if he/she were to participate in the study. 4. pregnant or breast feeding, or considering becoming pregnant during the study. 5. use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer). 6. use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine). 7. use of ustekinumab and/or anti-il-17 (interleukin 17) biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first ip dose. 8. patient used other topical therapies to treat within 2 weeks of the baseline visit (not including permitted topical therapy for face, groin and axilla). 9. patient received ultraviolet b, uvb phototherapy within 2 weeks of baseline. 10. patient received psoralen and ultraviolet a, puva phototherapy within 4 weeks of baseline. 11. patient has a known hypersensitivity to the excipients of topicort spray® as stated in the label.
autologous endothelial progenitor cell therapy for reversal of liver cirrhosis

Conditions: End Stage Liver Disease

Summary: this proposal translates a hypothesis driven basic research into clinical setting to determine the potential of using autologous cd133+ cells to reverse fibrosis and improve clinical outcome for patients with end stage cirrhosis. this has significant impact on the management of cirrhosis.

this is a 2 arm randomised study patients with decompensated liver cirrhosis involving minimum of 23 and maximum of 33 patients in each arm. the investigators propose that transplantation of mobilized autologous cd133+ cells harvested from the bone marrow directly into the liver has the ability to replace and regenerate the damaged sinusoidal endothelium as well as normalize macrophage and natural killer (nk) cell function. the niche provided by the refenestrated endothelium can polarize the macrophage to antifibrotic phenotype as well as directly inactivate the activated myofibroblast, resulting in reversal of liver fibrosis and improvement in liver function. transplantation of cells will be via intraportal route delivered by percutaneous cannulation of the portal vein system.

Eligibility criteria:
inclusion criteria: * liver cirrhosis of any aetiology but where active disease is controlled * childs a/b/c with child-pugh score \>= 5 and either one of the following: 1. meld score 10-27 2. clinically significant portal hypertension as evidenced by gastroesophageal varices or ascites exclusion criteria: * meld score \>27 * inr\>2.5 * hiv * history of hematological or hepatic malignancy within 5 years from consent * other underlying malignancy with \<1 year survival * presence of systemic diseases that may impact survival within 1 year. * listed for liver transplant