Kornimate/medical-research-clean huggingface dataset:
gdf-8 levels in icsi cycles

Conditions: Infertility

Summary: the aim of this study is to investigate the role of gdf-8 in regulating progesterone levels during controlled ovarian stimulation in patients undergoing icsi-et and to evaluate its effects on pregnancy rates. the main questions are * does serum gdf-8 correlate with serum progesterone levels during ovarian stimulation? * does serum gdf-8 serum level at different time-points during ovarian stimulation correlate with pregnancy rate? participants will undergo icsi-et cycle using the long gnrh-agonist protocol and serum levels of gdf-8 and progesterone will be measured at three time-points during the trial: on day of hcg trigger administration, on day of oocyte pickup, and 14 days after embryo transfer


Eligibility criteria:
inclusion criteria: * the study population included women who underwent their first icsi-et cycles due to male and/or tubal factors or unexplained infertility, aged 20-35 years, whose bmi ranged from 19-29.9 kg/m2, with regular menstrual cycles exclusion criteria: * women with pcos, couples with azoospermic husbands, women with poor ovarian reserve testing (amh \< 1.2 ng/dl and/or afc \< 5), women diagnosed with endometriosis, and women with medical comorbidities such as thyroid disorders, dm, hyperprolactinemia, etc.
a study to evaluate the long-term safety and efficacy of gdc-0853 in participants with moderate to severe rheumatoid arthritis enrolled in study ga29350

Conditions: Rheumatoid Arthritis

Summary: a study to evaluate the long-term safety and efficacy of gdc-0853 in participants with moderate to severe active rheumatoid arthritis (ra) who have completed 12 weeks of study treatment in study ga29350. eligible participants from study ga29350 who elect to participate will receive treatment with gdc-0853 twice daily (bid) in an open-label fashion for 52 weeks, followed by a safety follow-up period of 8 weeks.


Eligibility criteria:
inclusion criteria: * completion of treatment as specified in study ga29350, including completion of the day 84 study visit assessments * acceptable safety and tolerability during study ga29350 as determined by the investigator or medical monitor * have not received any prohibited medications in study ga29350 * while taking methotrexate, must be willing to receive oral folic acid (at least 5 milligrams per week \[mg/week\]) * if receiving oral corticosteroids (less than or equal to \[\</=\] 10 milligrams per day \[mg/day\] prednisone or equivalent) and/or non-steroidal anti-inflammatory drugs, doses have remained stable for the duration of study ga29350 exclusion criteria: * met protocol defined treatment stopping criteria during study ga29350 * treatment with any investigational agent (i.e., other than study drug) or live/attenuated vaccine or any other prohibited medication during study ga29350 or since the last administration of study drug in study ga29350 * in the opinion of the investigator, any new (since initially enrolling in the phase ii study ga29350), significant, uncontrolled comorbidity that would increase the risk to the participant in study ga30067 * pregnant or lactating, or intending to become pregnant during the study * participants who experienced a de novo or reactivated serious viral infection such as hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv) during the phase ii study ga29350 * any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during the phase ii study ga29350 * participants who developed a malignancy during the phase ii study ga29350 * 12-lead electrocardiogram (ecg) on day 84 in study ga29350 that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results * current treatment with medications that are well known to prolong the qt interval
clinical study to evaluate cryoballoon™ ablation system in patients undergoing esophagectomy

Conditions: Esophageal Cancer

Summary: to evaluate the safety and treatment effect of the cryoballoon™ full ablation system for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

the primary outcomes for the study are the safety and treatment effect of the cryoballoon™ ablation system. an esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed to determine the treatment effect.

Eligibility criteria:
inclusion criteria: * up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation * older than 18 years of age at the time of consent * requires a clinically-necessary esophagectomy for esophageal cancer * patient has provided written informed consent using the informed consent form approved by the institution's reviewing medical ethics committee (mec) exclusion criteria: * patient refuses or is unable to provide written informed consent * patient has esophageal narrowing limiting access to the intended site of ablation
rosuvastatin pretreatment to reduce myocardial periprocedural necrosis:comparison with atorvastatin reloading

Conditions: Assess the Periprocedural Myocardial Necrosis

Summary: an increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after otherwise successful percutaneous coronary interventions (pcis)(1) apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after pci might be distal embolization of atherogenic materials from plaque disruption,(2 )causing obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )recent studies have suggested that pretreatment with atorvastatin may be associated with a reduction in infarct size after elective pci. (5-7 ). actually the standard pretreatment in patients undergoing elective coronary-pci and already treated with aspirin is clopidogrel loading dose administration before procedure.(8,9)the investigators compared a high (80mg) re-loading dose of atorvastatin with a high loading dose of rosuvastatin (40 mg) both administered within 24h before the procedure in reducing the rate of periprocedural mi. therefore, the investigators will conduct a single center, prospective randomized study to assess whether a single, high (80mg) loading (within 24h)dose of atorvastatin compared with a single loading dose of rosuvastatin (20 mg) is effective in preventing elevation of biomarkers of mi after elective coronary stent implantation. we evaluate the incidence of macce(occurring of cardiac death, myocardial infarction (including periprocedural myonecrosis) and stroke at 30 days 6 and 12 month follow-up.


Eligibility criteria:
inclusion criteria: patients with stable angina exclusion criteria: baseline myocardial enzyme rise

Keywords: myonecrosis percutaneous angioplasty myocardial infarction
a study to evaluate the efficacy and safety of hbm9161 on moderate to severe thyroid eye disease

Conditions: Thyroid Ophthalmopathy

Summary: primary objective: to preliminarily evaluate the efficacy of the treatment regimen of hbm9161 680 mg administered subcutaneously weekly and sequentially every other week for 12 weeks in chinese patients with active moderate to severe ted.

this is a multicenter, randomized, double-blind and placebo-controlled study. the investigational drug is hbm9161 injection, with the indication of ted. subjects will be randomized to treatment group i, treatment group ii, or placebo group. subjects in treatment group 1 will receive hbm9161 680 mg subcutaneously once weekly (qw) for 12 doses; subjects in treatment group 2 will receive hbm9161 680 mg subcutaneously once weekly (qw) for 6 doses, followed by hbm9161 680 mg subcutaneously once every two weeks (q2w) for 3 doses; subjects in placebo group will receive placebo subcutaneously once weekly (qw) for 12 doses. after the 12-week dosing period, there will be a 5-week follow-up period.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent form. 2. male or female between the ages of 18 and 70 (including boundary values). 3. active ted associated with a clinical diagnosis of graves' disease or hashimoto's thyroiditis with cas ≥ 3 at the screening visit and baseline (both on a 7-item scale) in the eye with the most severe proptosis. 4. the active period of ted starts within 9 months prior to screening visit 5. positive anti-tshr antibody at screening visit. 6. subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol. exclusion criteria: 1. other uncontrolled concurrent diseases 2. serious ted requiring surgery or radiotherapy 3. suffer from autoimmune diseases or ophthalmic conditions other than ted that, in the opinion of the investigator, would impact the assessment of the study drug 4. no significant laboratory abnormalities

Keywords: ted
duration of chest tube suction in traumatic pneumothorax

Conditions: Traumatic Pneumothorax

Summary: the purpose of this pilot study is to determine whether chest tube suction duration, 24 hours vs 48 hours, prior to water seal affects outcome and length of stay after placement for traumatic pneumothorax.


Eligibility criteria:
inclusion criteria: * trauma service consult/patient * traumatic pneumothorax with chest tube placed within 0-24 hours of presentation and confirmation of adequate position * age \>18 * blunt or penetrating mechanism * chest tubes sizes 14 to 32fr * chest tubes placed by residents on the trauma surgery service supervised by attending trauma surgeons or placed by the attending surgeon themselves * presence of single chest tube in one or both pleural cavities (single unilateral or bilateral tubes) * subjects with decision making capacity (dmc) who are able to provide written consent. dmc will be determined by the consenting physician through a teach back mechanism. subjects must demonstrate understanding of the situation, appreciation of the consequences of their decision, reasoning of their thought process, and be able to communicate their wishes. exclusion criteria: * age \<18 * pregnant patients * prisoners * mechanically ventilated in icu for more than 24 hours while chest tube in place * chest tubes placed as part of, or present during, a thoracic operation * history of surgery involving pleural cavity ipsilateral to chest tube * subjects with more than one chest tube on the ipsilateral side at any time prior to study chest tube removal * subjects with chylothorax or empyema * subjects with chest tubes that are withdrawn or removed unintentionally * subjects with known or suspected bronchial injury * subjects with bullous emphysema.
three model care pathways for postnatal depression

Conditions: Postnatal Depression

Summary: the study evaluates three best-practice care pathways for postnatal depression (pnd) by comparing sole general practitioner (gp) management to gp management in combination with cbt-based counselling from either a psychologist or a maternal and child health nurse (mchn).


Eligibility criteria:
inclusion criteria: * english-speaking women at 3-months postpartum exclusion criteria: * psychosis

Keywords: postnatal depression cbt-counselling primary care
evaluation of deltamaxx® microcoil system in intracranial aneurysms

Conditions: Intracranial Aneurysms

Summary: the primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the deltamaxx microcoil system.


Eligibility criteria:
inclusion criteria: * subject age ≥18 and ≤80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure * investigator intends to use deltamaxx microcoil system during coiling procedure * investigator intends to use only codman neuro microcoils during coiling procedure * aneurysm size \[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen\] ≥6 mm * if ruptured aneurysm: hunt and hess 1, 2, or 3 * if unruptured aneurysm: subject grade modified rankin scale 0 - 2 * the subject or his/her legally authorized representative must voluntarily provide informed consent for participation in this study and agree to return for all study visits. exclusion criteria: * prior treatment (surgical or endovascular) of the target aneurysm * subjects with more than one aneurysm (\>2 mm) that have been treated with endovascular or clipping techniques in the past 30 days. * subject with social, medical or psychological conditions that interfere with treatment and follow-up evaluation * women who are pregnant or plan to become pregnant during the study * life expectancy less than 12 months. * presence of arteriovenous malformation * fusiform, mycotic, traumatic, or tumoral aneurysms * planned aneurysm treatment by parent vessel occlusion * subject enrolled in any concurrent study
bioimpedance analysis for follow-up of dieters

Conditions: Obesity

Summary: prospective, single arm, dietary intervention study.

this prospective study was conducted during the period from december 2011 through june 2013 in the department of endocrinology and metabolism of başkent university. we enrolled 185 participants who were admitted to hospital for weight loss therapy. after initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. at the end of the follow up, 103 participants attended to the research. anthropometric, bioimpedance and laboratory measurements performed at baseline and second visit. we calculated the difference in anthropometric, bioimpedance and laboratory measurements between the first and second evaluations. correlation analysis, multivariate linear regression analysis and receiver operating characteristic analysis performed to assess associations of laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis (bia) measures, after diet and/or exercise therapy. the secondary aim was to determine whether abdominal bia was better than simple anthropometric measurements and conventional bia for assessing changes in metabolic variables.

Eligibility criteria:
inclusion criteria: * participants aged 18 to 70 years without chronic disease, cancer, a pacemaker, cardiac valve replacement, malabsorption syndrome, previous history of gastrointestinal surgery, thyroid disease, pregnancy, or a history of surgery during the previous 3 months. exclusion criteria: * participants receiving oral antidiabetic drugs, insulin, any treatment for obesity, steroids or hormonal drugs, over-the-counter drugs for weight loss, any kind of phytodrug, or any drug that could affect glucose metabolism. we also excluded patients who used any of these drugs after the initial evaluation. * participants who, at the second visit, reported that they failed to adhere to the diet.

Keywords: diet abdominal bioelectrical impedance analysis anthropometry insulin resistance
a two-week study assessing the onset of effect questionnaire (oeq) administered daily versus weekly in adult subjects

Conditions: Asthma

Summary: the purpose of this study is to demonstrate whether subjects respond similarly to the onset of effect questionnaire (oeq) using a 1 week recall period versus a 1 day recall period.


Eligibility criteria:
inclusion criteria: * male or female, \> 18 years of age * mild to moderate asthma requiring treatment with an inhaled corticosteroid * diagnosis of asthma for at least 6 months exclusion criteria: * subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular) * subjects with severe asthma, as judged by investigator * any significant disease or disorder that may jeopardize a subject's safety

Keywords: mild asthma moderate asthma
efficacy of gabapentin in the treatment of chest pain and paresthesia in patients with sternotomy

Conditions: Chest Pain; Paresthesia

Summary: in this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of pcpp to neuropathic pain syndromes.

because the primary objective of this study is to evaluate the effect of different drugs on chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end point design for this study. according to this design, both patients and physicians making first assessment are aware of the treatment but the investigators making second and third assessment are blinded to treatment. therefore, two separate cardiovascular surgeons wil select and randomize the patients and a cardiologist blinded to treatment assignments will evaluate the patients at second interview at thirty day and 3 months later. the study was approved by the local ethics committee and informed consent was obtained from each patient. the study was conducted in usak state hospital with collaboration the department of cardiology of ataturk education and training hospital.

Eligibility criteria:
inclusion criteria: * poststernotomy chest pain and/or paresthesia exclusion criteria: * osteoporosis, renal function impairment (creatinine value \>1.5 mg / dl.) * hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases * over production of scar tissue, thoracic surgery other than sternotomy - * redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass

Keywords: sternotomy pain paresthesia poststernotomy chest pain poststernotomy chest paresthesia
safety and efficacy of oms302 in subjects undergoing unilateral cataract extraction with lens replacement (celr)

Conditions: Cataract

Summary: the purpose of this study is to determine whether the use of oms302 (the study drug) in individuals undergoing cataract extraction with lens replacement (celr) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).


Eligibility criteria:
inclusion criteria: * competent and willing to voluntarily provide informed consent * 18 years of age or older * in good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia * other inclusion criteria to be evaluated by the investigator exclusion criteria: * no allergies to the medications and/or the active ingredients of any of the study medications * no medications with the same activities as the of the active ingredients in oms302 for defined time intervals prior to and after surgery * no other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication * other exclusion criteria to be evaluated by the investigator
pain inhibitory effects of other pain induced by mechanical pressure compared to electrical stimulation and cold water.

Conditions: Healthy

Summary: the objective is to estimate the effects on pain thresholds of a painful mechanical stimulus on the upper trapezius compared to a painful electrical stimulus and a diffuse noxious stimulus using the cold water hand immersion test.

the mechanical stimulus produced in manual therapy (mt) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. almost all types of mt elicit a neurophysiological response that is associated with the descending pain modulation circuit. but it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism induced by painful mechanical stimulation that is carried out with manual therapy techniques.

Eligibility criteria:
inclusion criteria: * healthy male or female between 18 and 65 years * free of pain and with no history of chronic pain exclusion criteria: * pregnant or having given birth within the last year

Keywords: conditioned pain modulation manual therapy physiotherapy physical therapy
development and validation of the observatory battery of common eye disorders for adults with intellectual disability

Conditions: Intellectual Disability

Summary: background: around 15% of the global population has some form of disability. rights to obtain proper health care is an emphasis in the united nationals convention on the right of people with disability. due to the importance of improving vision health for people with disabilities, studies on how to identify vision problems becomes extremely important in policy formulation for all countries. among all types of disabilities, people with intellectual disability (id) are among the ones where vision problems are the hardest to detect. currently, no caregiver assessable scales are available, as a result, adults with id are at high risk of delayed diagnose for common ocular conditions. objectives: this is a one-year project. the objective of this study is two folds: 1. to develop an item bank of ocular conditions of adults with id; 2. to develop a scale for caregivers to detect ocular conditions for adults with id, and to validate the reliability, construct validity and responsiveness of the scale.


Eligibility criteria:
inclusion criteria: 1. age 20 and above 2. primary caregivers for at least one adult with id (have disability identification or (and) certification). exclusion criteria: 1. unable to communicate in mandarin or taiwanese.(primarycaregivers) 2. unable to cooperate with eye examination.(id)

Keywords: intellectual disability, adults, visual scale, caregiver
hemiplegia arrhythmia retrospective trial

Conditions: Alternating Hemiplegia of Childhood

Summary: alternating hemiplegia of childhood (ahc) is a rare and severe disease that is in need of effective, and hopefully even curative, therapies. afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, frequently severe developmental and psychiatric/psychological disabilities and other comorbidities, such as cardiac disturbances. recent data indicate that ahc genotype is in relation to cardiac repolarization troubles and to cardiac arrhythmias. the primary hypothesis to explore is that there is an association between genotype and cardiac phenotype in ahc.


Eligibility criteria:
inclusion criteria: * patients that meet the clinical diagnostic criteria (aicardi et al, 1995) for typical alternating hemiplegia with or without identified mutations in atp1a3. * at least one ecg study is required. * patients ages yearand more exclusion criteria: * informed consent or assent not obtainable * atp1a3 testing not performed * no ecg studies are available

Keywords: qtc cardiac repolarization and arrhythmia ecg alternating hemiplegia