Kornimate/medical-research-clean huggingface dataset:
gtx-024 as a treatment for stress urinary incontinence in women

Conditions: Stress Urinary Incontinence

Summary: the purpose of this study is to determine whether gtx-024 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.


Eligibility criteria:
inclusion criteria: * give voluntary, written and signed, informed consent * female * age18 to 80 years old be clinically confirmed as postmenopausal. subjects must have undergone the onset of spontaneous, medically induced or surgical menopause prior to the start of this study. spontaneous menopause is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum fsh levels \> 40 miu/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy * sui symptoms for at least 6 months duration * predominant sui (mesa questionnaire) * 24 hour pad weight \>3 gms at baseline * a minimum of 1 sui episode per day, in the 3 day diary * 3-15 sui episodes per day, averaged over 3 days, in the 3 day diary * serum ast and alt within normal limits * total bilirubin within normal limits * positive bladder stress test during screening * subject agrees to not start any new treatment (medication or otherwise) that is known to affect lower urinary tract function throughout the treatment and follow up periods * subject agrees to maintain on a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, or alpha-adrenergic blockers, throughout the treatment and follow-up period exclusion criteria: * pelvic floor physical therapy in a clinical setting within 30 days prior to screening * history of pelvic radiation treatment * history of urethral diverticula * history of urethral sling, anterior prolapse repair, ureteral bulking agents and/or other sui procedure or surgery * known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant urological findings, including pelvic floor abnormalities which, in the judgement of the investigator, could impact treatment * urinary incontinence of neurogenic etilogy * patient is morbidly obese (defined as 100 pounds over their ideal body weight, or body mass index 40 or greater) * chronic hepatitis * hepatic cirrhosis * hiv and/or hepatitis a, b, or c * subjects taking systemic hormone products * subjects with a history of breast or endometrial cancer * myocardial infarction or arterial thromboembolic events within 6 months prior to baseline, severe or unstable angina, new york heart association (nyha) class iii or iv disease, serious uncontrolled cardiac arrhythmia grade ii or higher according to nyha, uncontrolled hypertension (systolic \> 150 and/or diastolic \> 100 mm hg) * subjects with an entry measurement of \> 5 mm endometrial stripe thickness * clinically confirmed urinary tract infection * any other condition which per investigators' judgment may increase subject risk
gs 5885 administered concomitantly with gs-9451, tegobuvir and ribavirin (rbv) in chronic genotype 1 hepatitis c virus (hcv) infection

Conditions: Hepatitis C, Chronic

Summary: the purpose of this phase 2 study is to determine whether 30 mg or 90 mg of gs-5885 when given with gs-9451, tegobuvir and ribavirin (rbv) for 12 or 24 weeks is effective, safe and tolerable in the treatment of chronic genotype 1 hcv infection.


Eligibility criteria:
inclusion criteria: * adult subjects 18 to 70 years of age * chronic hcv infection for at least 6 months prior to baseline (day 1) * liver biopsy results (performed no more than 2 years prior to screening) indicating the absence of cirrhosis * monoinfection with hcv genotype 1a or 1b * hcv treatment-naïve * body mass index (bmi) between 18 and 36 kg/m2 * creatinine clearance ≥ 50 ml/min * subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male. * screening laboratory values within defined thresholds exclusion criteria: * autoimmune disease * decompensated liver disease or cirrhosis * poorly controlled diabetes mellitus * severe psychiatric illness * severe chronic obstructive pulmonary disease (copd) * serological evidence of co-infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or another hcv genotype * suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers) * history of hemoglobinopathy * known retinal disease * subjects who are immunosuppressed * subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse * subjects must have no history of clinically significant cardiac disease, including a family history of long qt syndrome, and no relevant electrocardiogram (ecg) abnormalities at screening

Keywords: hepatitis c hcv rapid virologic response sustained virologic response direct acting antiviral combination therapy hcv rna polymerase inhibitor protease inhibitor treatment naïve gs-5885 gs-9451 tegobuvir
effect of endovascular inferior mesenteric artery embolization on colonic perfusion prior to rectal surgery for rectal tumor or sigmoid colon surgery

Conditions: Cancer, Sigmoid; Cancer, Rectum

Summary: the investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion.


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * the patient is at least 18 years old and less than 80 years old * patient has rectal cancer or sigmoid colon cancer requiring surgical treatment exclusion criteria: * the subject is participating in another study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient has a history of abdominal surgery * patient suffers from a hemostasis disorder (hemophilia, von willebrand disease, thrombocytopenia) and is on anticoagulant therapy. * patient whose general condition appears too precarious or is taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk. * renal insufficiency with clearance \<45ml / min * known allergy to contrast media * patient who had treatment of the abdominal aorta or its branches reported pregnancy (the existence of effective contraception will be verified for women of childbearing age). * anatomical variant at risk or absence of marginal artery highlighted at the time of arteriography. * abnormality of the superior mesenteric artery * historic occlusion of the inferior mesenteric artery
win: a feasibility study of a weight-neutral health intervention

Conditions: Obesity

Summary: the win intervention aims to improve the mental, social and physical health as well as quality of life of participants with bmi≥30 without focusing on their weight, and with no aim of weight loss. the win 6 months intervention is based on the principles and methods of the weight neutral movement health at every size (haes). the content is developed in a co-design process that involved danish participants who have lived or professional experiences with such approaches. the intervention uses the method of intuitive eating to align eating behaviours with internal cues of hunger and fullness rather than rules, restrictions and external cues. the intervention also draws on components from acceptance and commitment therapy (act) to manage body image concerns and weight stigma.

the win group intervention comprises bi-weekly two-hour sessions with 11-12 participants and two win-therapists. session 1 is an individual session and sessions 2-12 are group sessions. the programmes include psychoeducation, group discussions and homework about topics within the weight neutral approach such as intuitive eating, weight stigma, enjoyable movement and self-compassion. overview of sessions 1-12: 1. individual session with a win therapist to explore the participant's expectations and needs in relation to commencing intuitive eating and body acceptance. 2. introduction to weight-neutral health 3. your body, your rules 4. intuitive eating i 5. intuitive eating ii 6. body respect and weight stigmatization 7. self-compassion and confronting your inner critical voice 8. body awareness, rest and movement - yoga and your strong body 9. body awareness, rest and movement, intimacy and sexuality 10. follow-up on intuitive eating 11. follow-up on challenges 12. strategies for resilience optional win elements include two support network events, up to 24 2-hour sessions of win-physical activity (rest and movement (12 sessions) and competent body training (12 sessions)), and three individual online sessions.

Eligibility criteria:
inclusion criteria: * age ≥18 years old at screening. * bmi ≥30 kg/m2. * residence in the capital region of denmark. * able to understand and communicate in danish. * informed consent. exclusion criteria: * intends to become pregnant during the intervention or is currently pregnant. * has used weight loss medications or glp-1 agonist treatment within the past 6 months or intends to use weight loss medications or begin any other intensive weight loss treatment during the win intervention. * has severe psychiatric or physical conditions that may interfere with participation or may present a safety concern. * cannot transport themselves to the group sessions. * is deemed unable to complete a two-hour group session, as assessed by the investigator at the clinical screening interview. * takes part in other research involving weight loss treatment that would compromise participation in this study.
combined q-switched nd:yag laser and platelet rich plasma versus q- switched nd:yag laser alone in melasma

Conditions: Hyperpigmentation; Melasma; PRP; Lasers

Summary: melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. melasma is considered a disappointing challenge when treatment options are addressed. diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels, microdermabrasion, and lasers have been tried for the treatment of melasma. there is no universally proven therapy that induces and maintains remission of the condition. q-switched: nd yag laser toning and platelet rich plasma (prp) are promising treatments for melasma.the aim of this work is evaluate the efficacy and safety of combined prp and q-switched: ndyag laser in the treatment of melasma using clinical assessment, in addition to assessment of melanin index and erythema index.


Eligibility criteria:
inclusion criteria: * patients with bilateral nearly symmetric melasma on the face. exclusion criteria: * patients receiving systemic or topical or laser treatment relevant to melasma within three months before enrollment into the study. * use of oral or injectable contraceptives or hormone replacement therapy during treatment or 12 months before * patients active skin infections and active hsv * history of hypertrophic scars or keloids. * patients with hypercoagulable state or bleeding diatheses * pregnant and lactating females. * history of liver diseases * intake of systemic chemotherapy, corticosteroids, antiplatelets or anticoagulants

Keywords: laser toning hemi-masi colorimeter erythema index melanin index
brentuximab vedotin or b-cap in the treatment of older patients with newly diagnosed classical hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the purpose of this trial is to determine 1. objective response rate (orr), defined as the proportion of patients having cr, crr or pr in the centrally reviewed restaging after six cycles of chemotherapy 2. progression-free survival (pfs) 3 years after registration


Eligibility criteria:
inclusion criteria (b-cap): * classical hodgkin lymphoma * age 60 years or older * ecog performance status ≤ 2 or ≤ 3 if due to hl * cirs-g score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and throat) * advanced stages: stage iib with large mediastinal mass and/or extranodal lesions, stage iii or iv disease * written informed consent exclusion criteria (b-cap): * composite lymphoma or nodular lymphocyte- predominant hodgkin lymphoma (nlphl) * prior chemotherapy or radiation for hl except prephase * peripheral neuropathy greater than ctc grade 1 inclusion criteria (bv only): * classical hodgkin lymphoma * age 60 years or older * stage ia to ivb * cirs-g score of ≥ 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat) * patients not eligible to curative poly-chemotherapy at the investigators judgment * written informed consent exclusion criteria (bv only): * composite lymphoma or nodular lymphocyte- predominant hodgkin lymphoma (nlphl) * prior chemotherapy or radiation for hl except prephase as outlined in the protocol * peripheral neuropathy greater than ctc grade 1
the use of airway clearance devices in als

Conditions: Amyotrophic Lateral Sclerosis

Summary: the investigator is examining the use of one airway clearance medical device compared to the use of two airway clearance medical devices together in patients with amyotrophic lateral sclerosis (als). more specifically, the investigator wants to know how effective the use of either a mechanical high frequency chest compression (hfcc) device is on its own or the use of both a mechanical high frequency chest compression (hfcc) device and cough assist together to maintain a healthy airway and clear secretions. the first device is a passive form of mechanical high frequency chest compression (hfcc), which was designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area. the second device, called a cough assist, aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing. this study will enroll up to 20 people in total at csmc.

this 180 day (25.7 weeks) pilot study is designed to evaluate the effectiveness of airway clearance devices in adults with als. subjects will be randomized in a 1:1 ratio to one of two treatment groups: treatment with a mechanical hcff device alone or treatment with both a mechanical hfcc device and a cough assist device. this outpatient study includes a screening/baseline visit followed by a 180 day (25.7 weeks) treatment period with three scheduled clinic visits (day 30, day 90, day 180). pulmonary assessments and als outcome measures will be collected at each visit in addition to quality of life assessments and device usage diaries.

Eligibility criteria:
inclusion criteria: 1. suspected, possible, probable, probable (lab-supported), or definite als according to el escorial criteria 2. males and females age 18 and above 3. novel to airway clearance device use 4. forced vital capacity ≤ 75% of predicted exclusion criteria: 1. any contraindication for pulmonary ventilation scan including allergy to radioisotopes 2. any contraindication for use of a pulmonary clearance device * susceptibility to pneumothorax * recent (within 30 days) barotrauma * unstable head or neck injury * active hemorrhage with hemodynamic instability

Keywords: airway clearance devices high frequency chest compression devices cough assist
comparing of a 22g eus procore fine needle biopsy device and a 20g eus procore fine needle biopsy device

Conditions: Pancreas Neoplasms

Summary: the purpose of this study is to compare the diagnosis accuracy of 22g eus procore fine needle biopsy （fnb）device and 20g eus procore fine needle biopsy device for solid pancreatic lesions.

this is a single-blind, randomized, controlled trial. one thousand two hundred and twenty four patients with solid pancreatic lesions referred for eus guided fine needle biopsy will be randomly assigned to 4 arms. for arm a1 which will be used with 22g eus procore fine needle biopsy device, the pass sequence is slow pull(sp)-modified wet suction technique(mwst)-slow pull(sp)-modified wet suction technique(mwst). for arm a2 with 22g eus procore fine needle biopsy device, the pass sequence is mwst-sp-mwst-sp. for arm b1 with 20g eus procore fine needle biopsy device, the pass sequence is sp-mwst-sp-mwst. for arm b2 with 20g eus procore fine needle biopsy device, the pass sequence is mwst-sp-mwst-sp. all procedures will be performed by experienced echoendoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. the primary outcome measure is the diagnosis yield. secondary outcome measures are specimen quality.

Eligibility criteria:
inclusion criteria: 1. age \>18 years old,\<85 years old; 2. gender: male or female; 3. presence solid occupying pancreatic lesions (the diameter\>1cm); 4. must be able to receive examinations in the research center; 5. must be able to sign the informed consent. exclusion criteria: 1. hemoglobin≤8.0 g/dl; 2. pregnant women; 3. coagulation disorders; 4. took anticoagulants such as aspirin, warfarin in the latest week; 5. acute pancreatitis in the past two weeks; 6. cardiopulmonary dysfunction; 7. cannot sign the informed consent

Keywords: eus-fnb slow pull modified wet suction technique
study to evaluate the safety and antiviral activity of remdesivir (gs-5734™) in participants with moderate coronavirus disease (covid-19) compared to standard of care treatment

Conditions: COVID-19

Summary: the primary objective of this study was to evaluate the efficacy of 2 remdesivir (rdv) regimens compared to standard of care (soc), with respect to clinical status assessed by a 7-point ordinal scale on day 11.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent prior to performing study procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and \< 18 years of age) prior to performing study procedures. for participants ≥ 12 and \< 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures * severe acute respiratory syndrome coronavirus (sars-cov)-2 infection confirmed by polymerase chain reaction (pcr) test ≤ 4 days before randomization * currently hospitalized and requiring medical care for covid-19 * peripheral capillary oxygen saturation (spo2) \> 94% on room air at screening * radiographic evidence of pulmonary infiltrates key exclusion criteria: * participation in any other clinical trial of an experimental treatment for covid-19 * concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against sars-cov-2 * requiring mechanical ventilation at screening * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 x upper limit of normal (uln) * creatinine clearance \< 50 ml/min using the cockcroft-gault formula for participants ≥ 18 years of age {cockcroft 1976} and schwartz formula for participants \< 18 years of age note: other protocol defined inclusion/exclusion criteria may apply.
blood indices of systemic inflammation in critically ill patients with abdominal sepsis

Conditions: Abdominal Sepsis; Critically Ill

Summary: this study aims to clarify the role of blood indices of systemic inflammation in icu-admitted patients with abdominal sepsis to assess their diagnostic significance as well as their prognostic value.

sepsis is a complex, multifactorial syndrome which can evolve into conditions of varying severity. if left untreated, it may lead to the functional impairment of one or more vital organs or systems. severity of illness and the inherent mortality risk escalate from sepsis, through severe sepsis (defined as sepsis associated with at least one acute organ dysfunction, hypoperfusion, or hypotension) and septic shock up multi-organ failure. previous studies have demonstrated that mortality rates increase dramatically in the event of severe sepsis and septic shock. abdominal infection is a common indication for admission to the intensive care unit (icu) and the abdomen is the second most common site of invasive infection among critically ill patients in epidemiological and therapeutic studies. abdominal infections are more often associated with septic shock and acute kidney injury than are infections in other sites. the spectrum of disease and severity is broad and management of these infections is challenging. the inflammatory response in patients with sepsis depends on the causative pathogen and the host (genetic characteristics and coexisting illnesses), with differential responses at local, regional, and systemic levels. on the systemic level, several indices have been used as a mirror to outcome in patients with various pathologies, of which are the blood indices of systemic inflammation. as these blood indices are easy and available investigation that may be promising predictors in sepsis, we aim in this study to evaluate their role in abdominal sepsis.

Eligibility criteria:
inclusion criteria: 1. patients above the age of 18 years old. 2. patients fulfilling the systemic inflammatory response syndrome (sirs) criteria. 3. patients with an established diagnosis of abdominal sepsis, clinically and by investigations. exclusion criteria: 1. patients below the age of 18 years. 2. patients with haematological disorders. 3. patients with concomitant severe morbidity affecting the prognosis other than sepsis e.g. hypovolemic shock, brainstem infarction, pulmonary embolism, etc.

Keywords: blood indices of systemic inflammation
remote ischemic preconditioning in type 2 diabetic patients undergoing cabg

Conditions: Diabetes Mellitus; Coronary Artery Bypass; Remote Ischaemic Conditioning

Summary: this randomized, double-blind, prospective clinical trial aims to investigate the effect of remote ischemic preconditioning (ripc) on myocardial protection in patients with type 2 diabetes mellitus undergoing elective coronary artery bypass graft (cabg) surgery. perioperative myocardial injury remains a significant concern during cabg, particularly in high-risk patients such as those with diabetes. ripc is a low-cost, non-invasive intervention that may reduce myocardial damage by enhancing ischemic tolerance through intermittent limb ischemia. sixty patients aged 40-85 years with type 2 diabetes scheduled for isolated cabg will be randomized to either receive ripc or standard care. ripc will be applied through five cycles of upper limb cuff inflation and deflation prior to sternotomy. high-sensitivity troponin t levels will be measured at 24, 48, and 72 hours postoperatively to assess myocardial injury. secondary outcomes include acute kidney injury (kdigo classification), maximum vasoactive-inotropic score (vis) during the first 72 postoperative hours, icu and hospital length of stay. this study will provide insight into the cardioprotective role of ripc in diabetic patients undergoing cardiac surgery.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus and receiving medical treatment * scheduled for isolated elective coronary artery bypass graft (cabg) surgery * american society of anesthesiologists (asa) physical status class iii or iv * age between 40 and 85 years exclusion criteria: emergency cabg surgery reoperation (revision surgery) left ventricular ejection fraction (lvef) \ 20 μmol/l or inr \> 2.0) renal failure (egfr \< 20 ml/min/1.73 m²) ongoing treatment with glibenclamide or nicorandil (agents known to interfere with ischemic preconditioning mechanisms) asthma

Keywords: high sensitive troponin t diabetes mellitus type 2 coronary artery bypass myocardial ischemia remote ischemic conditioning acute kidney injury cardioprotection