Kornimate/medical-research-clean huggingface dataset:
preovulatory uterine flushing with saline as a treatment for unexplained infertility

Conditions: Unexplained Infertility; Infertility

Summary: the purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.

in vitro fertilisation is the only current reasonable treatment for unexplained infertility. uterine flushing, associated with a five-fold increase in pregnancy when performed preovulatory, has been proposed as a new alternative. this treatment could flush out debris or alter inflammatory factors preventing fertilisation and implantation. the objective of this study is to assess the efficacy of pre-ovulatory uterine flushing with physiological saline for the treatment of unexplained infertility. this study is a randomised controlled trial based on consecutive women aged between 18 and 37 years consulting for unexplained infertility for at least one year. the day of their luteinizing hormone surge, 192 participants will be randomised in two equal groups to either receive 20 millilitres of physiological saline by an intra-uterine catheter or 10 millilitres of saline intravaginally. investigators will assess relative risk of live birth (primary outcome), as well as pregnancy over one cycle of treatment. side effects, complications, and acceptability of the intervention will be reported.

Eligibility criteria:
inclusion criteria: * primary or secondary infertility ≥12 months. * diagnosis of unexplained infertility ≤24 months: * anti-mullerian hormone ≥0.4 ng/ml and/or follicle-stimulating hormone ≤13 iu/l in early follicular phase; * regular cycle of 21-35 days, * positive ovulation tests, and/or * luteal phase serum progesterone ≥25mmol/l in a natural cycle; * semen analysis with total motile sperm count ≥ 5 million; * normal uterine cavity; * patent tubes. * negative genitourinary test for gonorrhoea and chlamydia ≤12 months. exclusion criteria: * body mass index ≥35 kg/m2. * ongoing pregnancy.

Keywords: unexplained infertility infertility tubal flushing uterine flushing live birth pregnancy randomized controlled trial saline physiological saline
the efficacy nad safety of dwp16001 compared to active drug in the treatment of type 2 diabetes mellitus

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: the purpose of this study is to determine the efficacy and safety of dwp16001 compared to active drug in the treatment of type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: 1. adults aged 19 to 80 years 2. subjects with 7% ≤ hba1c ≤ 11% at screening 3. subjects with bmi of 20-45 kg/m2 exclusion criteria: 1. different type of diabetes mellitus which is not t2dm (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria) 2. symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention 3. severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy) 4. egfr \< 60 ml/min/1.73 m2 5. severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc. 6. uncontrolled hypertension (sbp \>180 mmhg or dbp \> 110 mmhg)
effect of diaphragmatic myofascial release on thoracic angle and pulmonary functions in hyperkyphotic adolescents

Conditions: Adolescent Kyphosis

Summary: adolescent kyphotic girls will participate in this study. they will be divided into two groups. group a: the control group will receive a therapeutic exercise program. group b: the study group will receive the same intervention as group a in addition to diaphragmatic myofascial release. they will be assessed at baseline and after three successive months of interventions for the following outcomes: cobb angle by x-ray and pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer

adolescent kyphotic girls with an age range of 12-15 years old will participate in this study. they will be divided into two groups. group a: the control group will receive a therapeutic exercise program. group b: the study group will receive the same intervention as group a in addition to diaphragmatic myofascial release. both groupss will receive intervention for three three successive months. they will be be assessed at baseline and after three three successive months of interventions for the following outcomes: primary outcome: cobb angle by x-ray secondary outcome: pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer

Eligibility criteria:
inclusion criteria: * adolescents girls with thoracic kyphosis with cobb angle ranged from 45 to 55 degree. * age ranged from 12 to 15 years old. * selected from preparatory and secondary schools. exclusion criteria: * free from any associated deformities other than the thoracic kyphotic deformity.
a study of lasmiditan in participants with migraine

Conditions: Migraine Disorders

Summary: the purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it during an acute migraine attack and also during the time between acute migraine attacks. information about any side effects that may occur will also be collected. this study includes two study periods. each study period requires an overnight stay in the clinical research unit (cru) for at least one night (and up to three nights), followed by up to two outpatient appointments. this study will last approximately 5-6 weeks (not including screening). follow-up is required four to seven days after last dose of investigational drug. screening is required within 28 days prior to the start of the study. this study is for research purposes only and is not intended to treat any medical condition.


Eligibility criteria:
inclusion criteria: * males or females with history of migraine with or without aura, as defined by international headache society (ihs) international classification of headache disorders (ichd)-3 beta guidelines (1.1 and 1.2) (ichd-3 beta, cephalalgia 2013), for at least 1 year, based on medical history * have a body mass index (bmi) of 18.0 to 40.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening exclusion criteria: * have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan * have participated, within the last 30 days, in a clinical study involving an investigational product. if the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed * have an abnormal blood pressure, defined as systolic blood pressure less than or equal to (≤) 90 or greater than (\>) 155 millimeters of mercury (mmhg) or diastolic blood pressure ≤ to 50 or \>95 mmhg * have clinically significant electrocardiogram (ecg) findings, including a qt interval corrected for heart rate using qt interval corrected for heart rate using fridericia's formula (qtcf) value \>450 milliseconds (ms) (males) or \>470 ms (females), clinically significant bradycardia, cardiac block, or bradyarrhythmias * have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, major depressive disorder) * have a history of gastrointestinal surgery, or a history of or current irritable bowel syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders. appendectomy, splenectomy, and cholecystectomy are considered as acceptable * have used or intend to use any migraine prevention treatments (including, but not limited to, propranolol or topiramate) within 30 days prior to dosing and until the follow-up visit
a long-term safety and tolerability extension study of bapineuzumab in alzheimer disease patients

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with alzheimer disease who participated in study 3133k1-3001(nct00676143). over 250 sites will participate in over 26 countries. subjects will receive bapineuzumab. each subject's participation will last approximately 4 years.


Eligibility criteria:
inclusion criteria: * subject has completed study 3133k1-3001 (week 78) and brain magnetic resonance imaging (mri) scan consistent with the diagnosis of alzheimer disease * mini-mental status examination (mmse) \>=10 at screening * caregiver able to attend all clinic visits with subject exclusion criteria: * any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response. * any significant brain mri abnormality. * use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening

Keywords: antibody immunotherapy
feasibility study of exercise in patients with leg blood clots

Conditions: Deep Vein Thrombosis

Summary: the purpose of this pilot study is to assess the feasibility of determining the effects of a structured exercise program started two to four weeks after diagnosis of a first episode lower-extremity deep vein thrombosis (dvt) for a period of 12 weeks in reducing the incidence of post-thrombotic syndrome (pts).

deep vein thrombosis (dvt) affects nearly 300,000 people in the u.s. each year. dvt of the leg results in pts in up to 65% of patients,despite receiving appropriate medical management with anticoagulant therapy. pts, caused by persistent venous outflow obstruction and venous valvular dysfunction, may result in symptoms of leg pain, swelling, heaviness and cramping especially with prolonged standing. all eligible patients with documented first-episode dvt interested in participating will undergo medical screening and a screening treadmill test prior to enrollment between two and four weeks post dvt diagnosis. all patients will be provided and asked to wear class ii (30 to 40mmhg) knee length compression hose daily during the entire trial. the formal exercise training includes both a supervised walking program and a home-based walking program for 12 weeks with follow-up at 26 weeks. blood tests will be taken to measure levels of indicators of inflammation at baseline, week 4, week 12, and week 26. the primary outcomes will be the feasibility of the exercise program and the incidence of post-thrombotic syndrome at 26 weeks.

Eligibility criteria:
inclusion criteria: * first episode lower extremity dvt (proximal or distal) documented by ultrasound, ct angiogram or venogram within last 4 weeks. * treatment with lmwh, or unfractionated heparin (ufh) followed by warfarin adjusted to keep inr 2 to 3 for at least 3 months, or lmwh given in therapeutic doses as sole therapy. * age 21 to 75 years old. exclusion criteria: * recurrent dvt. * treatment of dvt with systemic or catheter-directed thrombolysis contraindications to exercise training according to the american college of sports medicine (e.g., acute myocardial infarction, unstable angina, etc.,). * life expectancy \< 1 year. * pregnancy. * geographic inaccessibility. * screening (pre-randomization) exercise stress test demonstrating contraindication to exercise training (see exclusion #2). * cognitive dysfunction assessed by mini-mental status exam (score \< 24). * inability to walk.

Keywords: lower extremity dvt clot leg clot deep vein thrombosis thrombosis warfarin
efficacy and safety of tegoprazan and minocycline dual therapy for helicobacter pylori initial treatment

Conditions: Helicobacter Pylori Infection Chronic Gastrit

Summary: the purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for helicobacter pylori initial treatment. it is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.patients diagnosed with h. pylori infection will be randomly divided into one of the above treatments. at week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.


Eligibility criteria:
inclusion criteria: 1. age between 18\~70,both gender. 2. patients with documented h.pylori infection who did not receive helicobacter pylori eradication treatment; 3. patients are willing to receive eradication treatment. 4. women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after th exclusion criteria: 1. patients with contraindications or allergies to the study drug. 2. severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases. 3. constant use of anti-ulcer drugs ( including taking proton- pump.inhibitors(ppi) within 2 weeks before the \[13c\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening). 4. pregnant or lactating women. 5. underwent upper gastrointestinal surgery. 6. patients with moderate to severe dysplasia or high degree of intraepithelial neopla 7. patients have symptom of dysphagia. 8. evidence of bleeding or iron efficiency anemia. 9. a history of malignancy. 10. drug or alcohol abuse history in the past 1 year. 11. systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 12. patients who has psychological problem or poor compliance. 13. enrolled in other clinical trials in the past 3 months. 14. refuse to sign informed conse
comparison between the lingually based and the buccally based triangular flap design in the surgical removal of impacted mandibular third molars

Conditions: Tooth, Impacted

Summary: the primary objective of this study was to compare between the lingually based triangular flap with the buccally based triangular flap in the surgical removal of impacted mandibular third molars.

many flap designs used for impacted third molar surgery do not place the mucoperosteal incision on sound bone, as they involve incisions that are placed on the extraction socket resulting in higher incidence of mucosal dehiscence, followed by secondary wound healing this study involved 20 patient with bilaterally mesially angulated impacted third molar (class ii position b). one side was surgically removed using the lingually based triangular flap and the other side was surgically removed using the bucally based triangular flap

Eligibility criteria:
inclusion criteria: presence of impacted third molar that is misally angulated and retained in bone (class ii position b). exclusion criteria: * patients with a history of systemic disease (diabetes, renal failure, immunocompromised patients, cardiac patients and patients taking radiotherapy or chemotherapy ) * compromised dental and periodontal status * heavy smoking. * pregnancy or lactation
efficacy of pegintron (peginterferon alfa-2b) and rebetol (ribavirin) in treatment-naïve subjects with chronic hepatitis c in clinical practice in greece (study p05209)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: the objective of the study is to evaluate the rates of hepatitis c virus (hcv) eradication and relapse in participants treated with pegintron and rebetol in clinical practice in greece. participants will not be treated as part of the study. data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in greece.


Eligibility criteria:
inclusion criteria: * participants who have already begun summary of product characteristics (smpc)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date. * participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment. * participants who have achieved negative hcv rna at the end of treatment, defined according to genotype (24 weeks for hcv genotypes 2/3 and 48 weeks for genotypes 1/4). * participants with diagnosed chronic hepatitis c (chc) and hcv genotype 1, 2, 3 or 4. * participants older than 18 years, regardless of gender or race. exclusion criteria: * the participant has received treatment for chc in the past (not treatment-naive). * the participant has received treatment in the context of a clinical trial in the participating site. * the participant has been diagnosed with a concomitant infection e.g. with hepatitis b or hiv * the participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia. * the participant has positive hcv rna at the end of treatment. * pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the smpc of rebetol. * the participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the smpc. * the participant has interrupted treatment for any reason.
web-based respiratory education about tobacco and health phase ii

Conditions: Intervention (Training) Condition; Control (Delayed Training) Condition

Summary: the primary aim of this study was to develop an interactive internet-based program (webreathe: web-based respiratory education about tobacco and health) to train pediatric respiratory therapists and nurses to provide brief, hospital-based tobacco cessation interventions to parents of pediatric patients. the webreathe program was based on a phase i prototype which was evaluated with 50 pediatric respiratory therapists and nurses. in phase ii, the investigators redesigned and expanded the program with input from 50 educators, nurses and respiratory therapists from cincinnati children's hospital medical center. then the investigators evaluated the phase ii program in a randomized trial in which 215 respiratory therapists and nurses from two large, urban children's hospitals were randomly assigned within hospital to either the intervention (training) condition, or to a delayed treatment (training) control condition. participants' demographic and tobacco use history were measured at baseline, and tobacco cessation intervention behaviors, attitudes, knowledge, perceived barriers, and self-efficacy regarding delivery of a tobacco cessation intervention were measured at baseline, 1 week post-training, and at 3 months post-training. user satisfaction measures were also collected at 1 week post-training from intervention condition participants. the investigators hypothesized that participants in the intervention condition would have increased tobacco cessation behaviors, positive attitudes and self-efficacy, and decreased perceived barriers than participants i the delayed-treatment control condition. following evaluation, the investigators developed a final version of the interactive training program and created the administrative infrastructure for a marketable product.


Eligibility criteria:
inclusion criteria: * must be a respiratory therapist, nurse or nurse practitioner at the 2 pediatric hospitals participating in the study. * must be at least 18 years of age. exclusion criteria: * under 18 years of age.

Keywords: tobacco cessation continuing education pediatric respiratory therapist nurse
comparative effectiveness of empagliflozin in the us

Conditions: Diabetes Mellitus, Type 2

Summary: empagliflozin, a sodium glucose co-transporter 2 (sglt-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (t2dm) in the u.s. in august 2014. in contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the empa-reg outcome trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality. however, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. this study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.


Eligibility criteria:
inclusion criteria: * patients \>= 18 years old for marketscan and optum, and \>=65 years old for medicare only * patients initiating empagliflozin or a dpp-4 inhibitor within the study period. initiation was defined as no use of sglt-2 inhibitors (canagliflozin, dapagliflozin, ertugliflozin) or dpp-4 inhibitors in the previous 12 months. * restriction to patients with a diagnosis of t2dm (icd-9 dx code of 250.x0 or 250.x2; icd-10 dx code of e11.x) in the 12 months prior to drug initiation. exclusion criteria: * patients with missing or ambiguous age or sex information. * all patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a dpp-4 inhibitor will be excluded. * patients with type 1 diabetes mellitus (t1dm) defined as at least 1 inpatient or outpatient codes in the 12 months prior to drug initiation. * secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation * history of cancer in the 5 years prior to drug initiation * end-stage renal disease (esrd) in the 12 months prior to drug initiation * hiv diagnosis or treatment in the 12 months prior to drug initiation * organ transplant in the 12 months prior to drug initiation * patients that were in nursing homes in the 12 months prior to drug initiation * patients with concomitant sglt-2 inhibitor and dpp-4 inhibitor initiation will also be excluded. * patients initiating more than one dpp-4i on cohort entry date will additionally be excluded additional exclusion criteria apply.
a study of ketorolac for the treatment of inflammation and pain associated with cataract surgery

Conditions: Cataract Extraction; Pain; Inflammation

Summary: this is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing cataract surgery exclusion criteria: * uncontrolled ocular disease in cataract surgery eye