Kornimate/medical-research-clean huggingface dataset:
a study investigating ways to make local anaesthetic hand surgery less painful - reducing tourniquet associated pain

Conditions: Hand Injuries/Disease Requiring Surgery to the Hand

Summary: hand surgery requires a reduced blood flow to the hand during the operation, which is achieved using a tourniquet (tightly inflated circumferential cuff) around the upper arm. however this tourniquet is painful. this study investigates whether breathing oxygen can reduce the pain associated with the tourniquet to both improve patient experience and potentially to allow longer operations to be completed under a local anaesthetic (rather than a general anaesthetic, where the patient is put to sleep, which is more costly, time consuming and risky for the patient).

* this study is a randomised controlled trial of healthy volunteers (for example medical students, nurses and doctors). * each volunteer is randomised to receive either oxygen or normal air through a mask whilst wearing an inflated upper arm tourniquet and rating their pain on a scale. the equipment set-up is identical for each volunteer, with the tourniquet inflated to a pressure of 250mmhg in every person. * within each arm of the study, volunteers are again randomised to wear the tourniquet on either their dominant or non-dominant arm. * the study is double-blind (the volunteer and the investigator running the test are unaware of whether oxygen or air is being received) to avoid bias. * the volunteer can ask for the tourniquet to be removed at any time and will wear the tourniquet for a maximum of 30 minutes. * the pain ratings and also heart rate and blood pressure are then analysed to identify whether the volunteers receiving oxygen experienced less pain or were able to tolerate the tourniquet for longer than those receiving air.

Eligibility criteria:
inclusion criteria: * healthy * more than 18 years of age exclusion criteria: * diabetes * vascular disease * previous operations to arms * raynaud's disease * analgesia taken in last 24 hours * chronic pain * hypertension * allergy to any substance used in the study * unable to give valid consent to participate * obesity

Keywords: hand surgery tourniquet pain oxygen
sequent please drug coated balloons versus primary stent application in long sfa lesions

Conditions: Stenosis; Occlusion; Restenosis

Summary: patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.

patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the sfa or arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. vessel patency will be evaluated by quantitative angiography after 12 months. clinical follow-ups will be done until 36 months post-intervention.

Eligibility criteria:
inclusion criteria: * paod and rutherford classes 2 - 4 (pain-free walking distance \<500 m) * eligible for peripheral revascularization by means of pta * peripheral lesions in the superficial femoral artery (sfa) and / or the pi-segment of the popliteal artery (a.pop.) * minimum diameter stenosis of ≥70% * treatment length at least 15 cm (lesion length at least 13 cm) * maximum of lesions to be treated should be 2 (all treated lesions should be treated within the randomization to the study group, i.e. either coated balloon catheters or coated stents or bare nitinol stents); in case of two lesions matching the eligibility criteria, the one presenting the worst attributes (length and stenosis degree) should be chosen as target lesion * long diffuse stenosis with or without occlusions may only be divided in separate lesions if non-stenotic (i.e. \ 2 cm, otherwise vessel segments will be treated as a single extended lesion * eligible for an operative vascular intervention in case of complications during the pta exclusion criteria: * rutherford class 1,5 or 6 * more than two stenotic lesions in the target vessel requiring treatment * inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion * in-stent restenosis of the study lesion * strongly calcified lesions with circumferential presence of calcifications and a lesion calcification length of \>4 cm * reference vessel diameter \ 6 mm * guide wire could not be successfully advanced across the lesion * lesions below the knee requiring treatment * target lesion is located in the pii-segment of the popliteal artery (a.pop.) or within a bypass graft * acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion * potential loss of leg due to critical or acute ischemia * no patent distal run-off vessel * medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumarine or conditions which prevent the intake of the double anti-platelet therapy for two months * female patient who is pregnant or lactating * under 18 years of age * patients under administrative or judicial custody (§20 act on medical devices, germany) * expected life span of less than 24 months

Keywords: paod drug coated balloon drug coated stent percutaneous transluminal angioplasty (pta)
the effect of "quantum-touch" on pain, fear, and anxiety of the children

Conditions: Pain, Acute; Child Behavior; Anxiety and Fear; Venipuncture Site Reaction; Quantum

Summary: this research is a randomized controlled experimental study designed to determine the effect of the quantum-touch method applied during the vascular access procedure in children aged 7-12 years, on the level of pain, fear and anxiety in children.

quantum-touch was first described by richard gordon and bob rasmusson in 1978; it activates life force energy by combining various hand positions, various breathing techniques and body awareness exercises. it is applied by directing the formed high energy field to an area of pain, stress or illness through therapeutic touch. tully found that quantum touch in reducing acute and chronic pain; walton reported that quantum-touch application is effective in chronic musculoskeletal pain. it is important to conduct studies with a high level of evidence investigating the effect of quantum touch, which is a non-pharmacological method, on pain, fear and anxiety for children of different age groups, which is easily applied during invasive procedures. based on this information, in this study, which was planned in a randomized controlled and experimental design, it was aimed to determine the effect of the quantum-touch method applied during the vascular access procedure in children between the ages of 7-12 on the level of pain, fear and anxiety in children.

Eligibility criteria:
inclusion criteria: * the child and family agree to participate in the research, * the child's being literate, * the child is between the ages of 7-12 * the child does not have a chronic and mental health problem. * no history of sedative, analgesic or narcotic substance use within 24 hours before admission * not having a febrile illness at the time of application * previous vascular access exclusion criteria: * the child and family do not agree to participate in the research, * the child's illiteracy, * having a visual and auditory problem, * the child is less than 7 years old or older than 12 years old * the child has a chronic and mental health problem * failure to open vascular access in a single attempt * having a phobia of pain
study of single and multiple doses of als-008176 in healthy volunteers

Conditions: Respiratory Syncytial Virus Infections

Summary: this study will assess the safety, tolerability, and pharmacokinetics (pk) of orally administered als-008176 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * male or female subjects, 18-55 years of age, in good health with screening laboratory values within limits specified by the protocol * body mass index 18-30 kg/m2 * female subjects must be of non-childbearing potential; male subjects must be surgically sterile or practicing birth control exclusion criteria: * clinically significant or uncontrolled medical illness * use, or anticipated use during conduct of the study, of concomitant medications

Keywords: rsv
a focused registry to document the use of the short- or long-stemmed radial head prosthesis (rhp)

Conditions: Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis; Post-traumatic Deformity or Arthroses; Failed Open Reduction Internal Fixation (ORIF) of a Radial Head Fracture; Failed Conservative Radial Head Fracture Treatment

Summary: the purpose of this focused registry is to evaluate the clinical implications of the rhp position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the rhp with a straight and curved stem.


Eligibility criteria:
inclusion criteria: * age 18 years or older * use of a short-or long-stemmed depuy synthes radial head prosthesis due to any of the following indications: * fresh fracture of the radial head which is not amendable to an adequate -steosynthesis * post-traumatic deformity or arthroses * failed open reduction internal fixation (orif) * failed conservative radial head fracture treatment * informed consent obtained, i.e.: * ability to understand the content of the patient information / informed consent form * willingness and ability to participate in the clinical investigation according to the clinical investigation plan (cip) * signed and dated ethics committee (ec) / institutional review board (irb) approved written informed consent exclusion criteria: * active infection at the affected elbow * any not medically managed severe systemic disease * pregnancy * prisoner * recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
prevention of early postoperative decline

Conditions: Delirium; Postoperative Cognitive Dysfunction

Summary: the purpose of this trial is to determine whether using a brain training program in the time leading up to as well as after heart surgery will reduce confusion and cognitive loss that can occur after surgery.

randomized, controlled pilot study with a convenience sample of 45 adult cardiac surgical patients. the main intervention to be studied will be the use of a neurocognitive training program (lumosity) for 10 days preoperatively, and then for four weeks postoperatively. the prescribed regimen of training will focus on the areas of cognitive function most commonly affected in the postoperative period, including working memory, attention, and processing speed. patients in the control arm will undergo current standard cardiac surgical postoperative care and will be asked to refrain from obtaining a lumosity account.

Eligibility criteria:
inclusion criteria: * adult patients undergoing cardiac surgery age 60-90 * cardiac surgery scheduled at least 10 days from enrollment * high school education level or equivalent exclusion criteria: * preexisting psychiatric illness * history of cerebrovascular event or seizure * non english speakers * baseline severe cognitive dysfunction including alzheimer's, parkinson's, or other severe forms of dementia * significant visual impairment * enrollment in another study involving cognition

Keywords: cardiac surgery delirium postoperative cognitive dysfunction
apremilast for chronic plaque psoriasis (cpp) patients who have failed one course of biologic therapy

Conditions: Chronic Plaque Psoriasis

Summary: this is a phase ii, open label, investigator-initiated study to be done at duke university medical center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed biologic therapy with apremilast 30 mg bid for 24 weeks. at the time of enrollment, the patient must have received biologic therapy without achieving a response of "almost clear" or "clear" according to pga or has not responded with a 75% reduction of pasi score. once deemed eligible, subjects will return for a baseline visit and receive apremilast therapy and instructions. subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects will be evaluated 28 days after last dose of apremilast for safety and efficacy.

data analysis data will be analyzed and reported after all subjects have completed follow-up phase of study. all subsequent data collected will be analyzed and reported in a follow-up clinical report. data \& safety monitoring dr. murray will be following all laboratory values and adverse events during this trial. in addition, celgene will provide a study monitor to, at regular intervals, review all data. all data will be reported to celgene.

Eligibility criteria:
inclusion criteria: * subjects 18-80 yrs diagnosed with moderate-to-severe chronic plaque psoriasis with a pga of 3 or greater and require systemic therapy * must have received a biologic therapy for cpp and did not achieve a pga of 'almost clear' or 'clear' * must meet lab criteria per pg 20-21 of protocol * all subjects must follow contraceptive measures as described in protocol, pg 21. exclusion criteria: * abnormal chest x-ray * significant abnormality of ecg * positive hiv ab, hepatitis b \& c * subjects with erythrodermic, pustular or guttate psoriasis are ineligible * serious local infection or systemic infection, or tuberculosis within 3 mos of first dose of apremilast
the prognosis effect of indocyanine green (icg) fluorescence guided surgery on disease-free survival (dfs) of stage iii colorectal cancer

Conditions: Colorectal Cancer Stage III

Summary: previous studies of indocyanine green (icg) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. however, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. the present study assessed the prognosis of stage iii colorectal cancer patients following icg fluorescence-guided surgery as compared to conventional surgery without the use of icg fluorescence imaging


Eligibility criteria:
inclusion criteria: * age \&gt; 18 years, * confirmed diagnosis of primary crc, * preoperative tumor stage of ct1 to ct4, n+, m0 as determined by contrast-enhanced computed tomography (ct), * no distant metastasis, and * american society of anesthesiologists(asa)physical status classification score of 1, 2, or 3 exclusion criteria: * history of previous colorectal surgery, emergent surgery, or palliative resection; * pregnancy or breastfeeding; * allergy or history of an adverse reaction to icg * severe mental disorder.

Keywords: colorectal cancer indocyanine green prognosis
fe in anterior teeth

Conditions: Pain, Postoperative; Apical Periodontitis

Summary: the purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with apical periodontitis.

foraminal enlargement (fe) is an intentional procedure that enlarges the cement canal. however, some rcts indicate that enlarging the fe causes postoperative pain, flare-up, and destroy the apical constriction, whilst some rcts pointed out there is no difference in terms of pain when a fe has been performed in maxillary anterior teeth with apical periodontitis. we will assess the risk of postoperative pain as risk ratio (rr). the binary (dichotomous) data: 0-44 mm: mild or no pain; 45-100 mm: moderate to severe pain.

Eligibility criteria:
inclusion criteria: mature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis. exclusion criteria: systemic disorders, diabetes, pregnancy, less than 18 years of age, immunocompromised, patients who had taken antibiotics in the past 1 month, patients who had a positive history of analgesic use within the past 3 days, previously accessed teeth.

Keywords: apical patency endodontics
effects of ramadan fasting on sleeping and quality of life

Conditions: Fasting; Quality of Life; Sleep Disorder

Summary: include participants who intend to practice ramadan fasting and accept to complete the three part of the study .

all volunteers and stable patients that intend to fast ramadan. each participant is examined during three separate visits. the week before ramadan (pre-r). the last week of ramadan (r). the last week of the month following ramadan (post-r). participants that miss one appointement or more are exluded from the study. patient recrutement is conducted in primary care centers of the state of monastir, out-patients clinic (cardiology, endocrinology) at the emergency department of fattouma bourguiba university hospital after a clarified written consent. all patients benifit of a routine examen and evaluation of the quality of life by short form 36 (sf36) test and sleeping by pittsburg sleep quality index (pqsi) score .

Eligibility criteria:
inclusion criteria: * adult patient intending to fast ramadan. exclusion criteria: * age \< 18 years old * hemodynamic instability. * myocardial infarction requiring urgent revascularization. * parkinsonism: tremor problem. * refusal, communication problem.

Keywords: ramadan fasting sf-36 score sleeping score
a study of ly3502970 in healthy overweight and obese participants

Conditions: Healthy; Obese

Summary: the main purpose of this study is to evaluate the safety and tolerability of ly3502970 in healthy overweight and obese participants. the blood tests will be conducted to measure how much ly3502970 is in the bloodstream and how the body handles and eliminates ly3502970 in these participants. the study will last up to 42 days excluding the screening period.


Eligibility criteria:
inclusion criteria: * participants with stable body weight for at least one month prior to randomization. * participants with body mass index (bmi) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²) * male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential exclusion criteria: * have known allergies to ly3502970 or other glucagon-like peptide-1 receptor agonists (glp-1 ra) analogs * significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders * have any type of diabetes with hemoglobin a1c (hba1c) ≥6.5 %

Keywords: pharmacokinetics safety and tolerability ly3502970
trueness of full arch scans and generated digital implant models

Conditions: Denture; Complete Edentulism

Summary: the goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible.

the main issues to evaluate are: * the trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies. * the trueness of the generated 3d-printed dims. participants will provide two types of impressions to compare after osteointegration; the first will be conventional open tray impression used as a gold standard comparator, the second will be digital scans with additional geometric scanning aids coupled with the scan bodies. accordingly generated 3d-printed dims will be printed and compared to the digital image to evaluate its accuracy.

Eligibility criteria:
inclusion criteria: * patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant hybrid dentures. * patients having a substantial bone height and width at prospective implant sites to install four standard-size inter-foraminal implants. * sufficient crown height space according to criteria of all-on-4. * good oral hygiene and motivation exclusion criteria: * patients with bad oral hygiene. * patients with limited mouth opening. * vulnerable groups. * uncooperative patients. * patients receiving or undergoing radiotherapy or chemotherapy. * patients with systemic diseases affecting bone metabolism. * smokers

Keywords: intraoral scanning digital implant models edentulous mandible screw retained prosthesis geometric scanning aids
addition of bismuth to the standard triple therapy for helicobacter pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: h pylori is an important cause of chronic gastritis and other complications. there is a decline in eradication rate for h pylori owing to multiple factors including drug resistance. we compare the effect of the addition of bismuth to the standard triple therapy in a randomized control trial. subjects were randomized into two arms. arm a received triple therapy including amoxicillin, clarithromycin, and omeprazole and arm b received quadruple therapy adding colloidal bismuth subcitrate. both arms received treatment for two weeks.

the study is a 2-arm, prospective, randomized, non-inferiority, unblinded, parallel design trial. the primary end point is post-treatment result after triple or quadruple therapy. secondary endpoints included the nature and frequency of side effects compared between the two arms. the study protocol was approved by the ethical review committee of the university. patients with dyspeptic symptoms who had h pylori infection, diagnosed through positive stool for h pylori antigen or presence of h. pylori organism in the histopathology of gastric mucosal biopsy, attending outpatient department of two campuses of the university hospital were included in this study.. group a received standard triple therapy for h. pylori eradication for a total 14 days and group b received bismuth-based quadruple therapy for h pylori eradication for the same period. the triple regimen was defined as a combination of amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose. quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily, in addition. h. pylori status was checked routinely after 6 weeks by stool sampling for h, pylori antigen. subjects were counseled to stop taking ppi or any antibiotic 2 weeks before stool h. pylori antigen testing. eradication of h pylori was defined as lack of detection of h pylori antigen in the stool via elisa method after triple or quadruple therapy.

Eligibility criteria:
inclusion criteria: patients with dyspeptic symptoms who had h pylori infection, diagnosed through positive stool for h pylori antigen or presence of h. pylori organism in the histopathology of gastric mucosal biopsy, attending outpatient department of two campuses of the university hospital were included in this study exclusion criteria: exclusion criteria were patients with age less than 12 years, age more than 80 years, recent antibiotic use, and treatment-experienced patients, where h. pylori couldn't eradicate after treatment, chronic illnesses with multiple comorbid for example, chronic liver disease, chronic kidney disease or terminal illness etc, pregnancy and allergy to any of the regimen components.

Keywords: h pylori; eradication; amoxicillin; clarithromycin; esomeprazole; colloidal bismuth subcitrate
ono-7436 phase ii study in japan

Conditions: Malignant Tumor

Summary: the purpose of this study is to examine the efficacy and safety of ono-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor


Eligibility criteria:
inclusion criteria: 1. patients age 20 years or older 2. patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours 3. patients whose performance status is 0 to 2 4. other inclusion criteria as specified in the study protocol exclusion criteria: 1. in case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin 2. patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on day 1 of the study 3. pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception 4. other exclusion criteria as specified in the study protocol

Keywords: ono-7436, aprepitant, vomiting, nausea