Kornimate/medical-research-clean huggingface dataset:
the study of the bx velocity stent in patients with de novo coronary artery lesions.

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to assess the safety and effectiveness of the sirolimus-coated bx velocity™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated bx velocity balloon-expandable stent. both stents are mounted on the raptor® rapid exchange stent delivery system.

this is a multicenter (up to 35 centers), prospective, randomized double blind study. this study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated bx velocity stent to the uncoated bx velocity stent, both mounted on the raptor rapid exchange stent delivery system. a total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. patients will be either randomized to the sirolimus coated or uncoated bx-velocity stent. patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. medical resource use during the 5 years follow-up period will be collected and analyzed.

Eligibility criteria:
inclusion criteria: 1. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b\&c, i-ii) or patients with documented silent ischemia; 2. treatment of a single de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment; 3. target vessel diameter at the lesion site is \>=2.50mm and \<=3.0mm in diameter (visual estimate); 4. target lesion is \>=15mm and \<=32mm in length (visual estimate); 5. target lesion stenosis is \>50% and \<100% (visual estimate); exclusion criteria: 1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck \>2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remains above normal at the time of treatment; 2. has unstable angina classified as braunwald iii b or c and a i-ii-iii, or is having a peri infarction; 3. unprotected left main coronary disease with \>=50% stenosis; 4. significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; 5. have an ostial target lesion; 6. angiographic evidence of thrombus within target lesion; 7. heavily calcified lesion and/or calcified lesion which cannot be successfully predilated; 8. documented left ventricular ejection fraction \<=25%;
sleep improvement therapy affects pregnancy outcomes in chinese singletons and twins by improving sleep quality

Conditions: Gestational Diabetes; Hypertension in Pregnancy; Preterm Labor; NICU Infants

Summary: during pregnancy, the physical and psychological changes of pregnant women, hyperemesis gravidarum, uterine compression, frequent urination, hip or pelvic pain, back pain, leg cramps, gastroesophageal reflux, changes in mental state, and even changes in lifestyle, habits and tastes may affect the sleep of pregnant women. due to the coexistence of physiological, psychological, social and other complex factors during pregnancy, the incidence of sleep disorders in pregnant women is relatively high, up to 50%, and shows an increasing trend with the increase of gestational week. not only seriously affect the quality of life of pregnant women, but also may lead to a variety of pregnancy complications, and even lead to adverse pregnancy outcomes. therefore, early identification, timely diagnosis and treatment of sleep disorders during pregnancy are important measures to improve or even reverse adverse pregnancy outcomes. although sleep disorders are more common and seriously harmful during pregnancy, people lack of understanding and attention to such diseases, and often regard them as normal clinical manifestations of pregnancy and neglect diagnosis and treatment. studies have shown that maternal sleep disorders are associated with hypertensive disorders during pregnancy, preterm birth, and gestational diabetes. current research objects mainly focus on single pregnancy, twin related research is less. the purpose of this study is to explore the perinatal sleep health of pregnant women with twin pregnancies, reduce the complications of pregnant women with twin pregnancies and improve the pregnancy outcomes of mothers and infants by improving sleep quality.


Eligibility criteria:
inclusion criteria: (1) pregnant women aged 18-45 years. (2) diagnosed with single or twin pregnancy within 12 weeks of pregnancy, report sleep quality problems, agree to participate in the study and sign the informed consent - exclusion criteria:have a prior serious underlying medical condition (e.g., diabetes, heart disease), mental illness, or other serious sleep disorder -
rescue therapy for helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with helicobacter pylori first-line treatment. however, no study has examined its efficacy for h. pylori rescue treatment. rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for h. pylori. the purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory helicobacter pylori.


Eligibility criteria:
inclusion criteria: * ability and willingness to participate in the study and to sign and give informed consent * confirmed h. pylori infection and with previous treatment experience exclusion criteria: * subjects naive to h. pylori treatment, * under 18 or over 80 years old * history of gastrectomy * pregnant or lactating women * previous history of tuberculosis * allergy to any of the study drugs * severe systemic diseases or malignancy * administration of antibiotics, bismuth, antisecretory drugs, or chinese herb medicine in the preceding 8 weeks

Keywords: helicobacter pylori rescue therapy
prescriptive mobilization versus a pragmatic mobilization

Conditions: Mechanical Low Back Pain

Summary: this study is designed to compare the outcomes of two types of manual therapy techniques on patients with low back pain. both immediate- and long-term outcomes will be examined. the investigators hypothesize there will be no differences between the two applied treatment techniques in immediate and longer-term assessments.

this randomized clinical trial is designed to compare the outcomes of a prescriptively applied non-thrust manipulation to a pragmatically applied non-thrust manipulation on subjects with mechanical low back pain. the study has two primary aims. specific aim 1 examines immediate effect differences between a pragmatically applied localized non-thrust manipulation versus a prescriptively applied, non-localized non-thrust manipulation in subjects with mechanical low back pain. specific aim 2 examines longer-term differences between a pragmatically applied localized non-thrust manipulation versus a prescriptively applied, non-localized non-thrust manipulation in subjects with mechanical low back pain. the investigators hypothesize there will be no differences between the two applied treatment techniques in immediate and longer-term assessments.

Eligibility criteria:
inclusion criteria: * patients will need to be 18 years of age or older with mechanically producible lbp. they will require a minimum modified oswestry disability index score of 20% and a baseline pain score of \>2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination. exclusion criteria: * the presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. lastly, if patients are enrolled in the study but do not receive a second outcome measure (follow up visit) they will be excluded from the final analyses.

Keywords: low back pain non-specific low back pain
sh t00186 in the treatment of primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the investigational drug sh t00186d is an oral contraceptive. the investigational drug used in this study contains the estrogen ethinylestradiol (ee) and the progestogen drospirenone (drsp). the aim of the present study is to evaluate efficacy and safety of the investigational drug in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during menstruation). two different regimens of intake of the same investigational product will be compared. patients have to undergo 2 -3 baseline cycles (depending on whether the patient was an oc user before), during which menstrual pain, bleeding events, and pain killer intake have to be documented. during this observation period, the intake of hormonal contraceptives is not allowed. other contraceptive methods (condoms with spermicide, pessary with spermicide) have to be used. if the patient is eligible for the study, she will be randomly assigned to one of the two treatment groups. treatment group a will take the medication according to an extended flexible regimen, i.e., tablet intake will be triggered by bleeding events. treatment group b will take the study medication in the 24 + 4 days regimen. that means, tablets to be taken on cycle days 1 - 24 contain the hormone combination, whereas tablets 25 - 28 do not contain any active ingredients, i.e., these are so called placebo tablets. treatment will last at least 140 days, but can be prolonged in treatment group a depending of occurrence of menstrual bleeding. the overall study duration will be 10 months for each patient. during the whole study period, 5 visits are planned. at screening and final examination, a thorough physical examination and a gynecological examination (including breath palpation and cervical smear ) will be performed. blood samples will be taken for safety laboratory parameters. additional examinations can be performed any time, if this becomes necessary for medical reasons. patients will be provided with a patient diary to document the intake of study medication, any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic (menstrual) pain and its intensity and its interference with daily activity, and intake of pain medication. the pain medication (ibuprofen) will be provided.


Eligibility criteria:
inclusion criteria: * otherwise healthy female patients with moderate to severe primary dysmenorrhea * prospective self-rated sum pain score of \>/= 8 during the 2 baseline cycles * age between 18 and 40 years (inclusive) with smoking habits as follows: * between 18 and 30 years of age. daily cigarette consumption not above 10 * above 30 years of age, no smoking exclusion criteria: * current signs of history of any forms of secondary dysmenorrhea * any concomitant disease of condition that requires any intake of analgesic medication * occurrence of less than six menstrual cycles before visit 1 following delivery, abortion, or lactation * clinically significant depression

Keywords: primary dysmenorrhea menstrual pain oral contraception
an open-label extension safety study of melas patients who completed tis6463-203 (prizm)

Conditions: Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)

Summary: the goal of this clinical trial is to evaluate the long-term safety and tolerability of zagociguat in patients with melas who completed the lead-in study tis6463-203. tis6463-204 is evaluating zagociguat in an open-label extension study at the daily dose of 15mg. the study medication is a once daily oral table and will be provided at the clinic and/or shipped to the participant's home. study assessments will be conducted during clinic visits which will occur at three months and then at six months. thereafter, clinic visits will occur every six months.

on screening visit day -1 (which corresponds to period 2 week 12 visit from lead-in study tis6463-203), participants will sign the informed consent form, be confirmed eligible for this open-label extension study and undergo screening visit assessments. eligible participants will begin dosing the next day on day 1 (there is no day 0) at home. participants will have a 3-month visit and 6-month study visit at the clinic and thereafter will have a clinic visit every 6 months. participants should have a follow-up visit 4 (+1) weeks after zagociguat discontinuation.

Eligibility criteria:
inclusion criteria: 1. signed an institutional review board (irb)/independent ethics committee (iec)-approved informed consent form (icf). 2. completed tis6463-203 treatment through the period 2 week 12 visit. 3. agrees to follow lifestyle restrictions. 4. other criteria per the protocol. exclusion criteria: 1. any medical condition or clinical finding that, per investigator judgement, would preclude safe study participation and/or completion of all trial requirements.

Keywords: melas
intracervical anasthesia in outpatient hystroscopy, can procedure be completed diagnostic and therapeutic with no need to general anaesthesia

Conditions: Infertility, Female

Summary: single blind randomized controlled study in which 80 patients coming for hystroscopy due to multiple indication as infertility, aub and missed iud were assigned for our study. both sample size and randomization were done by a computer program. patients were classified into 2 groups, group 1 study group was subjected to intracervical injection of 5 mi of mepivacaine hydrochloride at position 3 and 9 of the vaginal portion of the cervix, and at least 5 minutes post injection before procedure done. the control group received nsai injection 15 minutes before procedure and 5 ml of saline was injected in each side of cervix at 3 9 positions. hystroscopy was done if an abnormality is detected an intervention was done. a descriptive scale of pain was done into mild, moderate or severe (that lead to interruption of the procedures).

procedures: all patients were subjected to: 1. history taking 2. verbal consent to participate in our study 3. patient put in lithotomy position 4. casco speculum was applied exposing the cervix 5. betadine sterilization of the cervix then properly washed with saline as heavy metals of disinfectant may cause irritation with injection 6. multiple toothed volselum was used just to fix cervix 7. 3 cartridges of mepivacaine hydrochloride was filled in 10 mi syringe 8. do aspiration to exclude and avoid intravascular injection then infilterate slowly intracervical at both 3 and 9 positions 9. instruments are removed and at least 5 minutes later procedure started. 10. hystroscopy (rigid , 2.9 mm sheath) was introduced gently throw vaginoscopy exploring vagina , cervix and uterine cavity 11. patient was monitored for pain all through the procedure by descriptive scale, mild, moderate and severe. ( moderate who needed to take rest then continue , severe that necessitated interruption of the procedure 12. all patients were monitored for signs of vaso vagal attack as sings (low blood pressure and bradycardia) before and if needed during. occurrence of symptoms as pallor , sweet and fainting 13. all patients were monitored post procedure for persistence of colicky pain

Eligibility criteria:
inclusion criteria: 1. must be under 40 years 2. must be no history of renal or hepatic disease 3. must be no known hypersensitivity to local anaesthetic agents 4. must be no significant vaginal or cervical infection. exclusion criteria: * all patients with history of sever vasovagal attack during any gynecological procedures.

Keywords: intracervical anasthesia , outpatient hystroscopy ,
influence of percutaneous electrolysis on endogenous pain modulation

Conditions: Pain

Summary: percutaneous electrolysis is a minimally invasive approach that consists in the application of a galvanic current through an acupuncture needle. although several mechanisms and effects are attributed to percutaneous electrolysis, currently there are only a few publications that delve into this topic. the aim of this study is to investigate the influence of percutaneous electrolysis on the endogenous pain modulation. four groups of intervention will be involved: no-intervention, isolated needling procedure, low intensity percutaneous electrolysis and high intensity percutaneous electrolysis. the effects on the pain modulation system will be evaluated before and immediately after the intervention, through pressure pain thresholds, conditioned pain modulation and temporal summation.


Eligibility criteria:
inclusion criteria: * healthy asymptomatic subjects * aged 18 to 40 years * both genders exclusion criteria: * belonephobia or fear of needles * neurological, cardiovascular or metabolic diseases * any pathology or process that causes pain * cutaneous alterations * pregnancy * cognitive and sensitivity disorders * fibromyalgia * frequent or recent (24 hours before) intake of alcohol and other drugs * have received pharmacological, physiotherapeutic or other treatment in the last week * intake of caffeine in the two hours prior to measurement * vigorous physical activity on the day of testing

Keywords: electric stimulation therapy randomized clinical trial interventional ultrasonography percutaneous electrolysis endogenous pain modulation pain conditioned pain modulation sensory thresholds
the efficacy of intrathecal morphine versus intrathecal morphine-dexamethasone combination in cesarean delivery

Conditions: Caesarean Section

Summary: the efficacy of intrathecal morphine versus intrathecal morphine+dexamethasone combination added to bupivacaine in elective cesarean section under spinal anesthesia

the study will be designed as a double-blind, randomized clinical trial and will be conducted following approval by the local ethics committee. a total of 120 patients, aged 18-40 years, with an asa physical status of ii and scheduled for elective cesarean section, will be included. all patients will undergo standard preparation for spinal anesthesia. two large-bore intravenous lines will be inserted in each patient upon arrival in the operating room. participants will be randomly assigned to one of two groups (n = 60 per group) using sealed opaque envelopes. group i (morphine group) will receive spinal anesthesia consisting of 2 ml (10 mg) bupivacaine, 0.1 ml (100 mcg) morphine, and 0.5 ml saline. group ii (morphine+dexamethasone group) will receive a mixture of 2 ml (10 mg) bupivacaine, 0.1 ml (100 mcg) morphine, and 0.5 ml (2 mg) dexamethasone. intraoperative hemodynamic parameters (including age, height, and weight), asa scores, postoperative complications (such as nausea, vomiting, and pruritus), and postoperative pain levels will be recorded and analyzed.

Eligibility criteria:
inclusion criteria: * patients scheduled for caesarean sections * between 18-40 years * asa ii group * those who will undergo spinal anesthesia * those between 35-40 weeks of pregnancy * 1st and 2nd caesarean sections exclusion criteria: * those who prefer general anesthesia * those who are outside the age range of 18-40 * those who are asa iii and above * those with ht, dm, cardiac and respiratory diseases * preeclampsia, eclampsia, hellp * those with a history of drug use that affects the cardiovascular system * placenta previa, placenta acreta, placenta acreta those with a history of antiemetic or antidepressant drug use

Keywords: caesarean section morphine dexamethasone nausea-vomiting postoperative complications
safety and efficacy of primaquine for p. vivax

Conditions: Malaria

Summary: the melanesian states of the western pacific (papua new guinea, solomon islands and vanuatu) represent a unique and especially prescient challenge to malaria control and elimination. while the use of bed nets and other vector control and case management measures have achieved major advances in overall malaria control, the p. vivax and p. ovale species account for an ever-increasing burden of clinical disease. the lack of effective treatment of the hypnozoite stages of infection with these species result in ongoing relapses and a continuing reservoir of infection. the only known drug effective for treatment of the hypnozoite stage is primaquine; however the safe and effective dose of this drug in malaria treatment is still unclear. a recent study evaluated the safety and efficacy of two primaquine dosing regimens (0.25mg/kg and 0.5mg/kg) in a population in new ireland province, png. this study aims to replicate this methodology in vanuatu and solomon islands, to provide a more complete picture of primaquine efficacy and safety in each of the three countries of this region.

study aims primary to define and compare the efficacy of standard (0.25mg/kg/day for 14 days) and high-dose (0.5mg/kg/day for 14 days) primaquine in preventing early relapses from p. vivax in solomon islands and vanuatu. secondary to measure safety and toxicity of primaquine when administered as a standard or high-dose regimen in melanesian adults and children in solomon islands and vanuatu.

Eligibility criteria:
inclusion criteria: 1. age 12 months to 60 years 2. melanesian background and living in local area 3. microscopically (based on field microscopy) or rdt confirmed p.vivax regardless of parasite density. mixed infections (p.falciparum-p.vivax and p.malariae-p.vivax) can be included. exclusion criteria: 1. any signs of severe malaria (see who definitions) including: impaired consciousness, respiratory distress, severe anaemia (hb\<5), multiple seizures, frequent vomiting/ inability to swallow tablets, prostration, jaundice, hypotension, abnormal bleeding or hypoglycaemia. 2. clinical evidence of non-malarial illness (such as pneumonia or otitis media) 3. severe malnutrition (weight-for-age nutritional z score \[waz\] \<60th percentile) 4. permanent disability, which prevents or impedes study participation. 5. treatment with primaquine in the previous 14 days 6. residence or planned travel outside the study area during the follow-up period (precluding supervised treatment and follow-up procedures) 7. known or suspected pregnancy 8. currently breastfeeding 9. a positive rapid test for g6pd deficiency (binax or carestart rdt) following later pcr-based confirmation of malaria speciation, there may be some post-hoc exclusion of subjects in whom it is thought the initial field-based microscopic diagnosis may have been incorrect.