Kornimate/medical-research-clean huggingface dataset:
gabapentin as an adjunct to paracervical block for perioperative pain management

Conditions: Pain

Summary: this is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. the researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.

project summary justification for the project one half of all pregnancies among american women are unintended, with nearly 4 in 10 ending in pregnancy termination by abortion. elective abortions are among the most common outpatient surgical procedure, with an estimated 46 million performed worldwide annually. the management of pain is critical to patient care throughout the abortion experience since the vast majority of women will experience pain with the procedure. patients are most affected by pain during paracervical block, cervical dilation, suction aspiration, and post operatively with uterine cramping. innovation in pain control and reduction of anxiety, nausea and vomiting using a low cost, well-tolerated intervention could impact thousands of women each year. proposed research this is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. the researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication. new features gabapentin as an adjunct o pain management has proven beneficial in gynecological surgery. its use in similar surgical settings as an adjunct to pain management regiments has proven to be beneficial. it is generally well tolerated, inexpensive, has minimal side effects, and few contraindications. problems anticipated the high volume at the study clinic will benefit recruitment efforts, however, as the coordination of this study may potentially disrupt clinic flow there will be limits on daily recruitment. postoperative follow-up may be challenging, thus to reduce the impact of loss to follow-up, most of the outcomes are measured on the same day as the procedure. further, multiple contact approaches will be employed and a second incentive offered after completion of the postoperative assessment.

Eligibility criteria:
inclusion criteria: * women \>=18 years-old * presenting for a surgical abortion * fluency in english and able to provide informed consent * has a driver to take them home following the procedure exclusion criteria: * allergy, sensitivity or contraindication to gabapentin * severe renal disease * currently using gabapentin or pregabalin * contraindication to outpatient abortion under local anesthesia

Keywords: perioperative pain outpatient surgery obstetrics/gynecology pain management
immune response post pry vaccination of 2 formulations of dtpw-hbv vaccine given with rotavirus vaccine to infants

Conditions: Hepatitis B

Summary: to compare the two formulations of gsk biologicals' dtpw-hbv vaccine to concomitant administration of csl's dtpw vaccine and gsk biologicals' hbv with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.

randomized study with five groups to receive one of the following vaccination regimens: one of the two formulations of gsk biologicals' dtpw-hbv + gsk biologicals' hrv one of the two formulations of gsk biologicals' dtpw-hbv + placebo csl's dtpw + gsk biologicals' hbv

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol. * administration of one dose of hepatitis b vaccine at birth. * a male or female between, and including, 11 and 17 weeks of age at the time of the first dtpw vaccination. * free of obvious health problems as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required) * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Keywords: diphtheria pertussis prophylaxis hepatitis b diseases tetanus
adjunctive use of hyaluronic acid in multiple coronally advanced flap

Conditions: Gingival Recession, Generalized

Summary: the primary aim of this study is to evaluate whether the effect of ha in combination with xcm for the treatment of magrs with a multiple coronally advanced flap technique (mcaf) achieves better results than the xcm with mcaf alone in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (ktw) changes, probing pocket depth (ppd) changes, volumetric gain (vg), etc.), also with a digital approach, the patient-reported outcome measures (proms e.g. pain, swelling, bleeding) and lastly the expression of molecular mediators of tissue healing/regeneration. the hypothesis of this study is that at 6 months and 1 year follow-up the mcaf with xcm+ha is superior to the mcaf with only xcm in terms of recessions reduction and secondary clinical variables, including proms.


Eligibility criteria:
inclusion criteria: * at least 18 years old and able to sign informed consent * at least 2 adjacent teeth with rt1 and/or rt2 gingival recessions without interproximal exposure of the cej (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment * a minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest * available to attend study related procedures (including follow-up visits) exclusion criteria: * systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus); * current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers; * pregnant or nursing women; * history of previous periodontal surgery (mucogingival or other) on the teeth to be included; * furcation involvement in the teeth to be included; * presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated; * presence of fixed or removable prosthesis in the area to be treated
cap-assisted endoscopic sclerotherapy for internal hemorrhoids and rectal prolapse

Conditions: Internal Hemorrhoid; Rectal Prolapse

Summary: this clinical trial aims to evaluate the efficacy and safety of long needle and short needle in the treatment of internal hemorrhoids and rectal prolapse through caes (cap-assisted endoscopic sclerotherapy).

traditional endoscopic sclerotherapy for internal hemorrhoids require retroflection of the endoscope. retroflection of the endoscope has blind areas and affects the precise operation. and, short-needle injection can easily lead to artificial ulcer and secondary bleeding. caes is a new, minimally invasive endoscopic technique for the treatment of internal hemorrhoids and rectal prolapse. caes was performed based on the requirement of the cap, endoscope, disposable endoscopic long injection needle, enough insufflated air and sclerosing agent. it can accurately control the injection angle, direction and depth under direct vision, and avoid iatrogenic injury caused by ectopic injection to the greatest possible extent. to investigate the effect of long needle and short needle on the outcome of caes, participants with internal hemorrhoids and rectal prolapse were randomly assigned to a long needle group and a short needle group using a prospective, randomized, controlled study at multiple centers in china. the efficacy, adverse events and satisfaction of the two groups were observed.

Eligibility criteria:
inclusion criteria: 1. patients with internal hemorrhoids and rectal prolapse, combined with external hemorrhoids or without external hemorrhoids. 2. patients with bowel preparation. exclusion criteria: 1. history of anoscopic/endoscopic sclerotherapy. 2. patients with acute thrombotic external hemorrhoids. 3. patients with serious internal hemorrhoids of grade iv. 4. patients with anal stenosis, anal fissure, fistula, fecal incontinence, ulcerative colitis, crohn's disease. 5. patients with acute diarrhea in the past 24 hours. 6. hypertensive patients with uncontrolled blood pressure, patients with cerebrovascular accident and obvious bleeding tendency, pregnant women, mental disorders and decompensated cirrhosis.

Keywords: cap-assisted endoscopic sclerotherapy internal hemorrhoid rectal prolapse
epidemiological study on anemia and iron deficiency in pregnancy in medical institutions in some areas of china

Conditions: Prevalence

Summary: the purpose of this study is to describe the prevalence of anemia and iron deficiency in pregnancy through a multi-center, prospective follow-up study . to explore the influence factors of anemia and iron deficiency in pregnancy; to explore the influence of anemia and iron deficiency in pregnancy on maternal and fetal outcomes.

1. to understand the epidemiological characteristics of anemia and iron deficiency in pregnancy and describe the epidemiological situation of anemia and iron deficiency. 2. to explore the influence factors of anemia and iron deficiency in pregnancy. 3. to explore the influence of anemia and iron deficiency during pregnancy on the pregnancy outcome of mothers and infants.

Eligibility criteria:
inclusion criteria: * regular prenatal check-ups were conducted in the hospitals participating in the study, and pregnant women who planned to give birth in hospital were established a maternity health manual * 18 years and older * patients have to agree to participate by signing a consent exclusion criteria: * have severe chronic diseases with pre-pregnancy * suffer from severe mental illness

Keywords: iron deficiency anemia during pregnancy
computer-assisted total knee replacement kinematics: depuy sigma posterior cruciate substituting knee and the depuy sigma rp rotating platform knee

Conditions: Osteoarthritis, Knee

Summary: primary research questions: 1. do patients with knee osteoarthritis (oa) who undergo total knee replacement with a sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e. quality of life, function, range of motion) than similar patients who undergo total knee arthroplasty (tka) using the sigma fixed bearing knee? 2. do patients with knee oa who undergo tka with a sigma rotating platform have different knee kinetics and kinematics as measured by gait analysis than similar patients who undergo tka using the sigma fixed bearing knee? 3. do patients with knee oa who undergo tka with or without computer assistance have better clinical outcomes at two years following surgery (quality of life, function, range of motion)? 4. do patients with knee oa who undergo tka with or without computer assistance have different knee kinematics and kinetics as measured by gait analysis?


Eligibility criteria:
inclusion criteria: * age 45-75 years * undergoing primary total knee arthroplasty * clinically significant osteoarthritic degeneration exclusion criteria: * active articular infections * bilateral knee replacement (simultaneous) * previous joint infections * significant concurrent ipsilateral hip osteoarthritis * chronic pain syndrome requiring medications for control * history of chemical addiction * significant spinal stenosis, significant symptomatic sciatica * patients who are unlikely to comply with, participate in, or return for follow-up visits as described in the protocol * osteomyelitis, septicemia or other infections that may spread to other areas of the body * highly communicable diseases, immuno-compromising conditions and/or conditions that may limit follow-up (eg. aids, active tuberculosis, venereal disease, active hepatitis, neoplastic disease) * decreased mental comprehension and literacy * prior high tibial osteotomy * prior patellectomy * rheumatoid arthritis * pregnancy

Keywords: arthroplasty knee computer-assist gait total knee arthroplasty knee prostheses
benson relaxation technique combined with music therapy for fatigue, anxiety, and depression in hemodialysis patients

Conditions: Hemodialysis Complication; Fatigue; Anxiety Depression

Summary: this study carried out in the hd unit of a large-scale training and research hospital, and at a dialysis center associated with this hospital located in ankara, turkey. participants will be randomized to one of two study arms. arm 1: intervention group arm 2: control group hypothesis 1. the hd patients in the 8-week intervention of brt combined with music therapy will report lower fatigue scores than those in the control group. hypothesis 2. the hd patients in the 8-week intervention of brt combined with music therapy will perceive lower anxiety and depression than those in the control group.

patients undergoing hemodialysis treatment are susceptible to many complications. the inadequate stress-coping strategies render them vulnerable to high symptom burden and impaired quality of life. patients are given conventional treatments to stop or slow down the progress of nephron destruction and prevent complications associated with uremia. however, previous studies observed that these therapies may be limited in alleviating fatigue, anxiety, and symptoms of depression, and may pose severe side effects. therefore, in recent years patients have shown enhanced tendency to use complementary and integrative approaches including aromatherapy, acupuncture, massage, music, and relaxation to provide better control on their health and treatment process, feeling better physically, and emotionally, and as well as improve quality of life. the present study investigates the effects of benson relaxation technique combined with music therapy in two-centered, 2-arm, assessor blinded randomized, controlled study of 61 hemodialysis patients. arm 1: benson relaxation technique combined with music therapy ; arm 2: control. the investigators hypothesize that benson relaxation technique combined with music therapy will decrease severity of fatigue, anxiety, and depression.

Eligibility criteria:
inclusion criteria: * patients who were 18 years and older, * capable of communicating in turkish, * had received hd in last three months, * undergone hd at least two times in a week, * showed a willingness to participate in this study. exclusion criteria: * patients with aggravated conditions who would not be able to continue with the study, * other accompanying diseases that significantly affect the fatigue like copd, advanced, * heart failure, asthma, and malignant tumors, * diagnosed with major depression, * could not communicate in turkish, * used another complementary and integrative approach within the study period.

Keywords: anxiety depression fatigue hemodialysis music therapy relaxation
omni in open-angle glaucoma treatment

Conditions: Open Angle Glaucoma; Cataract; Eye Diseases; Glaucoma

Summary: this single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures. medication usage, iop and secondary surgical procedures necessary for iop control will be analyzed during the follow-up period.


Eligibility criteria:
inclusion criteria: * diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma * 0-3 topical ocular hypotensive medications at preoperative baseline. fixed combinations counted as number of components * open angles (shaffer grade ≥3) * early or moderate glaucoma (based on visual field) * subjects with a combined procedure should have had uncomplicated cataract surgery (i.e. intact and centered capsulorrhexis, intact posterior capsular bag, no evidence of zonular dehiscence or rupture, well centered iol) exclusion criteria: * any of the following prior treatments for glaucoma: * suprachoroidal stent * laser trabeculoplasty ≤6 months prior to omni procedure * trabecular bypass implanted ≤6 months prior to omni procedure * trabeculectomy or other bleb forming procedure including xen, express, glaucoma draining device/valve * prior canaloplasty, goniotomy, or trabeculotomy * forms of glaucoma other than oag including: acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma * under treatment with oral carbonic anhydrase inhibitor at the preoperative visit * clinically significant ocular pathology, other than age-related cataract and glaucoma. (e.g. wet amd, uveitis, corneal edema, proliferative diabetic retinopathy, optic neuritis in medical history)

Keywords: glaucoma open-angle glaucoma cataract glaucoma surgery ophthalmology omni
consistency lots vaccine study (v260-009)

Conditions: Rotavirus Infections

Summary: this study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational rotavirus vaccine.


Eligibility criteria:
inclusion criteria: * healthy infants exclusion criteria: * history of abdominal disorders from a birth defect, intussusception, or abdominal surgery * known or suspected problems with the immune system * fever at time of immunization * prior administration of a rotavirus vaccine * history of known prior rotavirus disease, chronic diarrhea, or failure to thrive.
efficacy of vildagliptin as an add-on therapy to metformin compared to metformin up-titration in chinese patients with type 2 diabetes.(vision)

Conditions: Type 2 Diabetes

Summary: this is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.


Eligibility criteria:
inclusion criteria: * chinese t2d patients who are inadequate controlled (6.5 %\< hba1c ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks), exclusion criteria: * type 1 diabetes and secondary diabetes * acute metabolic diabetic complications within the past 3 months. * acute infections which may influence glucose level. * evidence of significant chronic diabetic complications, * clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis, * fpg \> 270 mg/dl (15 mmol/l) * any of the following disease within the past 6 months: myocardial infarction (mi); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; congestive heart failure (chf) other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes; vildagliptin; metformin;
a phase 1 study to evaluate the safety and tolerability of different doses of pf-03526299 in healthy adult volunteers

Conditions: Healthy

Summary: the purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of pf-03526299 concentration in the blood following dosing by dry powder inhaler.


Eligibility criteria:
inclusion criteria: * healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years. * body mass index (bmi) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). * subjects who had a normal chest x-ray in the previous 6 months prior to screening exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * a positive urine drug screen. * history of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.
mortality surveillance of mrfit screenees

Conditions: Cardiovascular Diseases; Heart Diseases; Cerebrovascular Accident; Coronary Disease; Hypertension; Cardiomyopathy, Congestive

Summary: to ascertain the sixteen year mortality status of the 361,662 middle-aged men screened in 1973-1975 for the multiple risk factor intervention trial (mrfit).

background: the multiple risk factor intervention trial was a randomized primary prevention trial to test the effect of a multifactor intervention program on mortality from coronary heart disease in 12,866 high-risk men aged 35 to 57. the primary screening for mrfit began in november 1973 and continued through november 1, 1975. the primary screening was conducted at clinical center sites, central neighborhood locations, and places of employment. information was collected on smoking history, blood pressure, serum cholesterol, birthdate, race, and social security number as well as previous hospitalization for a heart attack and use of medication for diabetes. systolic and diastolic blood pressures were measured and blood drawn for serum cholesterol determinations. the results of the screening examination were transmitted to the coordinating center. design narrative: using data supplied by the social security administration, the vital status of the mrfit screenees was determined. a screenee was identified as deceased if the social security number and first two letters of the last name, as recorded on the mrfit screening form, matched a record on the social security administration master death file. the state health department was contacted to obtain the death certificate which was then coded for the underlying cause of death according to the international classification of diseases, 9th revision. because the social security adminstration master death file was not completely accurate, the national death index was also used. studies were conducted on the relationships of isolated systolic hypertension to stroke and coronary heart disease mortality, and on seasonal and regional variations in cardiovascular mortality. using data from the census bureau (education and income levels by zip code), the socio-economic status of participants was indirectly estimated and the coronary heart disease and cancer death rate differences between white and black men were evaluated by social class. studies were also conducted on the associations of cause- specific cancer mortality and serum cholesterol concentration, and on the association of serum cholesterol, diastolic blood pressure, and cigarettes smoked per day with mortality from coronary heart disease and cerebrovascular disease for black and white men.

Eligibility criteria:
no eligibility criteria