Kornimate/medical-research-clean huggingface dataset:
botulinum toxin for erectile dysfunction

Conditions: Sexual Dysfunction; Erectile Dysfunction

Summary: to evaluate the safety and efficacy of intra-cavernosal botulinum toxin injection as an alternative line of treatment in patients with erectile dysfunction - not responding to oral pde5i - through cavernosal smooth muscle relaxation.

the initial phase 1 study demonstrated safety and efficacy of botulinum toxin type a in the treatment of erectile dysfunction in a small randomized controlled trial of 24 men. the investigators conduct a phase 2 trial to confirm the initial results in a larger group of men.70 males will be included in the study. the participants will be subjected for full history taking, general and genital examination. penile duplex will be performed to assess a vascular etiology before the treatment and 2 weeks later. the patients will be randomized into a treatment group (35 patients) and a control group (35 patients). all patients will sign an informed consent. the treatment group will be injected ic with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color doppler assessment, followed, next day by 50 units of btx-a. the control group will be injected with the trimix solution during penile color doppler assessment followed next day with a normal saline injection. the erection hardness score (ehs) will be assessed during the doppler exam. procedure: at least 1 day after the penile color doppler test, the patient is placed in the supine position flaccid and stretched penile length and girth would be measured from tip of the penis to the pubic bone will be done. a rubber band will be applied to the base of the penis. the skin will be prepped with alcohol swabs followed by the ic injection of 100 units of btx-a. direct pressure will be applied for 2 minutes. the rubber band will be removed after 15 minutes. patients and controls will fill the sexual health inventory for men (shim) questionnaire and answer the the sexual encounter profile questions 1 and 2 (sep 2 \& sep 3), and the global assessment question (gaq) before and 4 weeks after treatment.

Eligibility criteria:
inclusion criteria: * 70 males will be included in the study recruited from andrology, sexology \& std's outpatient clinic, kasr el aini hospitals, cairo university, complaining of ed. * unable to develop erections sufficient for intercourse. * failing to respond to first line and second line treatments for erectile dysfunction with surgery as the only remaining treatment option. * age between 18 to 80 years. exclusion criteria: - significant cardiovascular disease interfering with sexual activity

Keywords: erectile dysfunction botulinum toxin a botox
study of durvalumab alone or chemotherapy for patients with advanced non small-cell lung cancer (pearl)

Conditions: Non Small Cell Lung Carcinoma NSCLC

Summary: this is a randomized, open-label, multi-center phase iii study to determine the efficacy and safety of durvalumab versus platinum-based soc chemotherapy in the first-line treatment of advanced nsclc in patients who are epidermal growth factor receptor (egfr) and anaplastic lymphoma kinase (alk) wild-type and with pd-l1 high expression (pearl)

patients with stage iv nsclc will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or soc therapy). the dual primary objectives of this study are to assess the efficacy of durvalumab versus soc in terms of os (overall survival) in all randomized patients and in patients who are at low risk of em (early mortality)

Eligibility criteria:
inclusion criteria * aged at least 18 years * documented evidence of stage iv nsclc * no sensitizing egfr mutation and alk rearrangement * pd-l1 high expression * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * prior chemotherapy or any other systemic therapy for advanced nsclc * prior exposure to immune-mediated therapy, including, but not limited to, other anti-cytotoxic t-lymphocyte-associated antigen 4 (ctla-4), anti-programmed cell death1 (pd-1), anti-programmed cell death ligand 1 (pd-l1), or anti pd-l2 antibodies, excluding therapeutic anticancer vaccines * brain metastases or spinal cord compression unless the patient is stable and off steroids for at least 14 days prior to start of study treatment * mixed small-cell lung cancer and nsclc histology, sarcomatoid variant * active or prior documented autoimmune or inflammatory disorders (e.g., colitis or crohn's disease\]

Keywords: nsclc pd-l1 durvalumab (medi4736) os
usage of spacers and the relationship with symptoms severity in copd elderly patients

Conditions: Pulmonary Disease; Chronic Obstructive

Summary: the goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics were recruited in this study. research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.

the goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. a convenience sample was used to recruit patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics from a teaching hospital in taiwan. research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.

Eligibility criteria:
inclusion criteria: * individuals aged 65 or above diagnosed with copd by a pulmonologist. * clear consciousness and communication abilities in mandarin or taiwanese. * consent to participate in this study and sign the informed consent form. exclusion criteria: * patients who are blind, deaf, unable to express themselves, and unable to understand the study explanation.

Keywords: chronic obstructive pulmonary disease spacer symptom severity
twenty-four month extension study of ba058-05-003 (abaloparatide) in participants with osteoporosis

Conditions: Postmenopausal Osteoporosis

Summary: the purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in study ba058-05-003 (nct02653417).

to assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (sc) versus placebo in the prevention of bone fracture after cessation of treatment. participants who completed the 18-month double-blind ba058-05-003 (active) study (nct02653417), after receiving abaloparatide-sc or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. complete details for study ba058-05-003 are reported in the clinicaltrials.gov study record nct02653417.

Eligibility criteria:
inclusion criteria: 1. the participant was enrolled, randomized to either the abaloparatide-sc (ba058) or placebo arm, and successfully completed study ba058-05-003 (nct02653417). 2. the participant was no more than 40 days from end-of-treatment (month 18) in study ba058-05-003 (nct02653417). exclusion criteria: 1. participants who were withdrawn from study ba058-05-003 (nct02653417) for any reason. 2. participants who experienced a treatment-related serious adverse event (sae) during study ba058-05-003 (nct02653417).

Keywords: ba058 abaloparatide-sc abaloparatide activextend osteoporosis fracture bone loss
prepare: a randomized trial of a pre-pregnancy weight loss intervention

Conditions: Overweight; Obese

Summary: the us obesity epidemic is being transmitted to the next generation. growing evidence suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during pregnancy, are associated with increased risk of pregnancy-related complications such as gestational diabetes and pre-eclampsia, and an increased risk that her child will become obese and face obesity-related health issues in later life. currently, over one-third of reproductive-aged women in the u.s. are obese \[body mass index (bmi) ≥ 30\]. our research team has shown that we can improve birth weight outcomes in babies of obese women who start a weight-management intervention program at 14 to 15 weeks of their pregnancy (soon after their first prenatal visit). however, organogenesis and metabolic programming begin early in the first trimester, well before the first prenatal visit. therefore, waiting to address mothers' weight, physical activity, and diet quality until the first prenatal visit is not optimal. given the need to reach overweight and obese women prior to pregnancy, and the institute of medicine's (iom's) recent recommendation, based on observational studies, that women should reach a healthy weight before conceiving, this randomized clinical trial will evaluate a comprehensive preconception weight loss program.

the goals are to help overweight and obese women (bmi ≥ 27) who are considering pregnancy to adopt improved dietary and physical activity habits and lose weight prior to becoming pregnant, and then help them maintain those habits and prevent excessive weight gain during their pregnancy. we model this intervention after successful, frequent-contact interventions designed by ourselves and other investigators. we start with face-to-face counseling followed by frequent telephone counseling contacts. the expected outcomes for mothers include reduced pregnancy-related weight gain (primary) and lower weight at the start of pregnancy (secondary) and for babies, decreased risk of exceeding national norms for weight at birth (secondary).

Eligibility criteria:
inclusion criteria: * current kaiser permanente northwest (kpnw) member * expects to be kpnw member for at least 2 more years * body mass index (bmi) ≥ 27 * not currently pregnant * access to computer with internet * completion of screening diet assessment * english speaking exclusion criteria: * taking medication (insulin or pills) for treatment of diabetes * gastrointestinal disease requiring special diet or medications (for example, ulcerative colitis, celiac sprue, phenylketonuria) * currently receiving treatment for cancer * renal disease (kidney disease requiring special diet or medication) * history of bariatric surgery * use of prescription weight loss medications in the last three months * another household member already participating in the prepare study

Keywords: pre-pregnancy weight management
endocytoscopy of upper gastrointestinal tract in acute graft-versus-host disease: a pilot study

Conditions: Endocytoscopy

Summary: the goal of this clinical trial is to test the assess the diagnostic effectiveness of endocytoscopy in patients with underlying ugi agvhd. the main question it aims to answer is: the effectiveness of ecs for diagnosing ugi agvhd. participants will undergo endoscopy, endocytoscopic evaluation and biopsy simultaneously. if there is a comparison group: researchers will compare endoscopic, endocytoscopic and pathologic findings of these patients.


Eligibility criteria:
inclusion criteria: * aged ≥ 14 years * developed ugi symptoms within first three months after engraftment or during the tapering of immunosuppressive agents exclusion criteria: * \< 14 year * with underlying gastrointestinal disease before allo-hsct * incomplete medical information

Keywords: endocytoscopy acute graft-versus-host disease
addition of muscle relaxants in a multimodal analgesic regimen for analgesia after primary total knee arthroplasty

Conditions: Pain, Postoperative

Summary: this is a prospective, cluster-randomized, two-arm, comparative study aimed at determining whether addition of tizanidine ( an oral muscle relaxant) to a multimodal pain regimen following primary tka reduces opioid consumption.


Eligibility criteria:
inclusion criteria: * - patients undergoing unilateral primary tka with underlying diagnosis of osteoarthritis. * asa i - iii * spinal anesthesia * all patients will have a total knee arthroplasty utilizing a medial parapatellar approach with cruciate sacrificing implants and patellar resurfacing. a tourniquet will be used in all cases. * men and women between 18 and 80 years who are willing and able to provide informed consent exclusion criteria: * opioid use greater than 10 mg/day morphine equivalents continuously for one month within 3 months preoperatively * inability to take/allergy to the protocol medications * contraindication to regional anesthesia * non-english speaking * asa iv or greater * psychiatric or cognitive disorders * allergy/contraindications to protocol medications. * renal insufficiency with cr \> 2.0 or hepatic failure * sensory/motor disorder involving the operative limb * pcs score \>20 * patients with severe cardiac or neurological conditions precluding the use of study medications * patients using anticoagulation other than aspirin for the 14-day period after discharge
role of arma in selective subset of refractory gerd patients.

Conditions: GERD; Reflux; Reflux Esophagitis

Summary: to study the role of a novel endoscopic treatment technique (arma) in gerd patients who doesn't respond to ppi therapy (proton pump inhibitor).

patients coming with symptoms of gastroesophageal reflux disease (gerd) - a digestive disease in which stomach acid or bile irritates the food pipe lining, will be screened for eligibility and informed written consent will be taken. at initial screening, score based on clinical symptoms i.e. gastroesophageal reflux disease- quality of life score (gerd hrql) \& frequency scale for the symptoms of gastroesophageal reflux disease questionnaire (fssg) score will be completed. all patients will undergo esophagogastroscopy (procedure to diagnose and treat problems in your upper gi (gastrointestinal) tract). to look for reflux (the backward flow of stomach acid into the tube that connects your throat to your stomach (esophagus)) related changes in the esophagus. esophageal high-resolution manometry (procedure to diagnose and treat problems in your upper gi (gastrointestinal) tract) will be done to measure the various parameters which help doctor understand your disease. 24-hr ph impedance (procedure to diagnose and treat problems in your upper gi (gastrointestinal) tract) will be done after stopping anti-secretory medicines (medicines for the long-term treatment of gerd) for atleast three days to assess for esophageal parameters. all patients will be divided randomly into two arms, arma and sham. those in the arma arm will receive arma procedure, while patients in the sham arm will receive only upper gastrointestinal endoscopy.

Eligibility criteria:
inclusion criteria: * normal upper gastrointestinal endoscopy and * 24 hour ph impedance: aet \< 6%, more than 80 refluxes * patients who are willing to give consent for the procedure exclusion criteria: * large hiatal hernia \>3cm * lower esophageal sphincter (les) pressure \>15 mm hg * paraesophageal hernia * ge flap valve grade iv (hill's classification) * barretts esophagus * esophageal dysmotility * asa physical status \>ii * previous esophageal or gastric surgery * pregnancy
a pharmacokinetic and metabolism study of 14c-labeled ro5185426 on patients with metastatic melanoma

Conditions: Malignant Melanoma

Summary: this open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of ro5185426 (rg7204; plexxikon; plx4032) in previously treated or untreated patients with metastatic melanoma. patients will receive continuous twice daily oral treatment with ro5185426. on day 15, a 14c-labeled dose will be administered. anticipated time on study treatment is until disease progression occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically confirmed metastatic melanoma, surgically incurable and unresectable stage iiic or iv (ajcc) * prior treatment for metastatic melanoma allowed; \>/= 28 days must be elapsed since previous systemic treatment prior to first administration of study drug * positive braf v600e mutation result (by roche codx test) * ecog performance status 0-1 * adequate hematologic, renal and liver function * body mass index (bmi) 18 to 32 kg/m2 inclusive exclusion criteria: * active cns lesions * history of or known spinal cord compression, or carcinomatous meningitis * anticipated or ongoing administration of any anticancer therapies other than those administered in this study * refractory nausea or vomiting, or other medical conditions that are capable of altering the absorption, metabolism or elimination of the study drug * known clinically significant active infection * known hiv positivity or aids-related illness, active hbv, or active hcv * previous malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin, melanoma in situ, and carcinoma in situ of the cervix * clinically significant cardiovascular disease or incident within the 6 months prior to study drug administration * patients who have had at least one dose of study drug (ro5185426 or comparator) in a clinical trial that includes ro5185426
ketogenic diet therapy in patients with acromegaly

Conditions: Acromegaly Due to Pituitary Adenoma; Ketogenic Diet; Mediterranean Diet

Summary: acromegaly is caused by a tumour located at the base of the brain in the pituitary gland that produces too much growth hormone (gh). symptoms caused by the excess of gh, and consequently increased insulin like growth factor 1 (igf-1), are disproportionate growth of body parts, fluid retention, snoring and excessive perspiration. the various metabolic changes that occur due to acromegaly increase the risk for insulin resistance, diabetes mellitus, arterial hypertension, sleep apnoea and thus an increased risk of cardiovascular disease if left untreated. the result is signs and symptoms, increased mortality, morbidity, and greatly reduced quality of life (qol). normalisation of gh and igf-1 gives a normalisation of mortality, however morbidity and qol do not (completely) normalise. after surgery, a somatostatin analogue is the primary medical treatment, however, normalisation occurs in only 40% of patients. recently, in a proof-of-principle study, the researchers showed that a 2-week ketogenic diet (low in carbohydrates) in patients with somatostatin analogues could significantly reduce igf-1 values. patients felt better and sometimes even needed less somatostatin analogues. this proof of concept led to the new hypothesis that acromegaly patients with somatostatin analogues should possibly be treated with a eucaloric low-carbohydrate ketogenic diet for a longer period of time to improve their biochemistry, symptoms and qol. additionally, this diet can make a significant contribution in the treatment of insulin resistance and glucose intolerance that often occur in this patient group.


Eligibility criteria:
inclusion criteria: * male or female, 18 years or older * diagnosis of acromegaly based on elevated gh and/or igf-i levels due to a pituitary tumor * igf-i levels above 80% upper limit of the normal range (xuln)) on a stable medication dose for at least 4 months * written informed consent exclusion criteria: * pregnancy or breastfeeding * pegvisomant treatment * has undergone pituitary surgery or radiotherapy within 6 months prior to s study entry; * it is anticipated that the patient will receive pituitary surgery or radiotherapy during the study; * history or presence of epilepsy; * participation in a trail of an experimental drug or device within 30 days prior to screening; * has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study * screening hba1c \> 6,5%; * use of antidiabetic medication other than metformin
chronic neuropathy following chemotherapy

Conditions: Peripheral Nervous System Diseases; Chronic Pain

Summary: this is a clinical study which is a follow-up of a previous prospective questionnaire study. all patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination.

this is a clinical study which is a follow-up of a previous prospective questionnaire study. all patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination. this is a collaboration and part of the data will be combined with other data in this collaboration

Eligibility criteria:
inclusion criteria: * all patients who have participated in a prospective questionnaire study exclusion criteria: * not able to visit in person.

Keywords: chemotherapy
ocular signs and symptoms in glaucoma patients switched from latanoprost 0.005% to preservative free tafluprost eye drops

Conditions: Ocular Hypertension; Open-Angle Glaucoma

Summary: the purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (xalatan) to preservative free tafluprost eye drops.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication. - evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.
feasibility of a water-soluble contrast application into dysphagia evaluation

Conditions: Dysphagia; Swallowing Disorder

Summary: in traditional video-fluoroscopic-swallowing study, a lipid-soluble contrast (barium sulfate) has been used more than 30 years. however, it can cause chemical pneumonitis and subsequently impair reliability of video-fluoroscopic-swallowing study if aspirated. the authors reviewed the safety and usefulness of an water soluble agent-based swallowing test.

parallel-group, case-controlled trial was conducted from september 2015 to november 2017. all the patients who referred for video-fluoroscopic-swallowing study were screened. based on the pre-emptive evaluation, high-risky patients were allocated to iohexol (omnipaque)-used video-fluoroscopic-swallowing study and others were allocated to barium sulfate-used video-fluoroscopic-swallowing study. statistical package for the social sciences 24 was used to perform statistical analysis for the data. quantitative data were presented as mean ± standard errors.

Eligibility criteria:
inclusion criteria: * all the patients who referred for video-fluoroscopic-swallowing study exclusion criteria: * none