Kornimate/medical-research-clean huggingface dataset:
premanifest huntington's disease extension study ii: creatine safety & tolerability

Conditions: Huntington's Disease

Summary: the purpose of this clinical trial is to extend the pre-crest-x study to further assess the long-term safety and tolerability of up to 30 grams daily creatine in individuals at-risk for huntington's disease (hd) and to assess whether biomarkers responsive to creatine in symptomatic individuals are informative in premanifest individuals over a longer duration.

extensive evidence exists that neurodegeneration begins many years before hd can be diagnosed clinically. therefore, it is most desirable to begin a neuroprotective therapy before or during this premanifest period with the aim of delaying onset, as well as slowing functional decline. cellular energy depletion is present early in hd and can be ameliorated by creatine, which helps regenerate cellular atp. preclinical evidence for creatine's potential neuroprotective effects in animal models of hd has been well-documented. before the clinical efficacy of creatine can be tested in premanifest hd, its long-term safety and tolerability must be assessed in these individuals and its ability to favorably modify biomarkers of hd should also be confirmed. this extension trial will continue to follow eligible individuals who completed the pre-crest-x extension study on open-label creatine (up to 30 grams daily) for long term safety and tolerability for an additional 24 months. other biological and imaging biomarkers of disease progression and potential response to treatment will also be assessed.

Eligibility criteria:
inclusion criteria: * individuals who have completed the pre-crest study. * individuals capable of providing independent informed consent and complying with trial procedures. exclusion criteria: -clinical evidence of unstable medical or psychiatric illness in the investigator's judgment. additional eligibility criteria apply.

Keywords: premanifest at-risk huntington's disease hd
a study of pregnancy and pregnancy outcomes in women with breast cancer treated with trastuzumab, pertuzumab in combination with trastuzumab, or ado-trastuzumab emtansine

Conditions: Breast Cancer; Pregnancy

Summary: the mother pregnancy registry is a united states (u.s.)-based, prospective, observational cohort study in women with breast cancer who have been or are being treated with a trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or ado-trastuzumab emtansine (kadcyla) during pregnancy or within 7 months prior to conception (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab emtansine exposure).


Eligibility criteria:
inclusion criteria: * pregnant; women identified at any trimester of pregnancy may enroll in this study as long as enrollment occurs prior to experiencing pregnancy outcome (that is \[i.e.\], live birth, stillbirth, or abortion) * exposure to at least one dose of trastuzumab (as adjuvant or metastatic treatment), pertuzumab plus trastuzumab combination treatment, or ado-trastuzumab emtansine during pregnancy or within 7 months prior to conception * united states resident exclusion criteria: * prior knowledge of pregnancy outcome (i.e., live birth, stillbirth, or abortion) at time of enrollment
alimta (pemetrexed) in patients with locally advanced or metastatic cancer

Conditions: Metastases; Cancer

Summary: this is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of alimta when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of metastatic or locally advanced cancer * prior chemotherapy is allowed * adequate bone marrow, liver and kidney function exclusion criteria: * prior treatment with alimta * brain metastasis * pregnancy or breast feeding

Keywords: metastatic cancer chemotherapy
sibutramine versus continuous positive airway pressure (cpap)in obstructive sleep apnea (osa) patients

Conditions: Obstructive Sleep Apnea; Obesity; Hypertension

Summary: the primary objective of this study is to observe if sibutramine is effective in improving the symptoms and signs of sleep apnea in obese patients. the secondary objectives are to document the effects of sibutramine on heart rate variability and 24-h arterial pressure values. we hypothesized that sibutramine will improve sleep disordered breathing, cardiac autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea (osa).


Eligibility criteria:
inclusion criteria: * eligible participants with non-treated osa syndrome were aged between 18 to 65 years, with a body-mass index (bmi) ≥ 30 kg/m2 or ≥ 27 kg/m2 in the presence of other risk factors such as controlled systemic hypertension, type 2 diabetes, dyslipidemia and/or visceral obesity (as defined by a waist circumference ≥ 102 cm in men and ≥ 88 cm in women). exclusion criteria: * exclusion criteria were uncontrolled systemic hypertension defined as blood pressure \> 145/90 mm hg, previous pharmacological or surgical treatment for weight loss, had already used cpap or had severe diurnal hyper somnolence requiring immediate treatment.
c scope visualization system prospective study

Conditions: Knee Injuries and Disorders; Shoulder Disease; Shoulder Injuries

Summary: evaluation of the performance and safety of the c scope visualization system

the c scope visualization system prospective study is a post-market, single-arm, prospective, multicenter study conducted in the united states. the purpose of the study is to evaluate the performance and safety of the c scope visualization system in the illumination and visualization of joints from diagnostic procedure through 1-week and 1-month follow-up.

Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older * subject can fluently speak and read english * subject is able to provide informed consent * subject agrees to all protocol-required follow-ups * subject meets the c scope indications for use according to approved labeling exclusion criteria: * history of open surgery to the index joint resulting in scarring that might inhibit evaluation with the c scope visualization system * suspected fracture of joint structures * subject has any contraindications listed in the approved labeling including active infection * in the opinion of the investigator, it is not in the subject's best interest to participate in the study

Keywords: visualization illumination arthroscopic procedures
ascertainment of peripheral blood or saliva samples for genetic epidemiology studies of familial cancers

Conditions: Breast Neoplasms; Ovarian Neoplasms; Colonic Neoplasms; Prostatic Neoplasms; Uterine Cervical Neoplasms; Leukemia; Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to better understand the genetic causes of cancer and the inherited tendency to develop cancer. to accomplish this, blood specimens and/or saliva samples and/or tumor and normal tissue blocks from patients and families of patients with cancer will be collected. blood specimens will be frozen and stored for analysis at a later date. tumor tissue and normal tissue will be stored for analysis at a later date. in order to perform this study, patients and members of their families will be asked to provide blood samples and/or saliva samples. individuals will be asked to provide a history of cancer in their relatives at the time the blood sample is given. no relatives will be contacted before they have been asked by a family member if they wish to participate in this study. if they do wish to participate, the relatives should indicate this by returning the "family member consent for contact form" after we receive this form, arrangements may be made for the family member to send in a blood and/or saliva sample or to come in person to provide the sample to us. except for family history, no medical information provided by one member of a family will be discussed with other family members. at the end of this form, we will also ask for your permission to be contacted in the future to discuss information about your health, additional research with your samples and/or certain research findings possibly related to your sample.

patients can provide either a blood or saliva sample for the protocol. for blood samples, two tubes of blood (approximately 20 cc) will be drawn from the patient, utilizing a sterile technique. the tubes will be rocked so as to mix the blood with the additive (edta) in the tubes. for saliva samples, approximately 2-4 ml of saliva will be collected in specialized oragene dna self-collection kit tubes. the sample(s) may also be used to detect new genes or changes in genes that may tell us who is at risk for certain types of cancer and/or other diseases.

Eligibility criteria:
inclusion criteria: * patients accepted for referral to the cancer family clinic of the department of medicine at memorial sloan-kettering cancer center are eligible for participation in this study. such patients should have a history of cancers of the breast, ovary, colon, prostate, uterus, non-hodgkin's lymphoma, leukemia, soft tissue sarcoma, endocrine neoplasms, or other malignancies presenting in first degree relatives or in successive generations as part of a suspected cancer family syndrome. * family members of probands including parents, sisters, brothers, half-brothers and sisters, sons, daughters, grandparents, as well as aunts and uncles are also eligible. * this study involves research which presents no greater than minimal risk to children. the assent of any minor should be obtained before the patient is entered into this study.

Keywords: blood salvia tissue
adjuvant effect of dexmedetomidine in ultrasound (usg) guided transvers abdominis plane block

Conditions: Postoperative Nausea and Vomiting

Summary: a total of 60 adult patients american society of anesthesiologists physical status i,ii, iii were randomized to group b (n = 30) receiving tap block with 0.25% bupivacaine and group d (n = 30) with 0.5 mcg/kg dexmedetomidine added to 0.25 % bupicavaine followed by general anaesthesia. total local anaesthetic volume was standardised with 20 ml each sides of the abdomen. hemodynamic responses to surgical incision and intraoperative fentanyl consumption were noted. visual analog scale (vas) scores were assessed on the emergence, at 1, 2, 3, 4, 5, 6 and 24 h. time to first rescue analgesic (when vas ≥4 cm or on demand), duration of postoperative analgesia, incidence of postoperative nausea-vomiting were also noted.

transversus abdominis plane (tap) block has been shown to provide postoperative pain relief following various abdominal and inguinal surgeries. the aim of this randomised controlled trial was to assess the effect of transversus abdominis plane (tap) blocks on opioid requirements and median hospitai stay, postoperative nause and vomitting in patients undergoing laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: * the patients undergoing laparascopic cholecystectomy exclusion criteria: * story of allergy to bupivacaine and dexmedetomidine * the surgery preceeded to laparatomy * recent abdominal operation history

Keywords: dexmedetomidine
a randomized, double-blind, placebo controlled phase iii study to investigate efficacy and safety of hlx10 + chemotherapy (carboplatin- etoposide) in patients with extensive stage small cell lung cancer (es-sclc)

Conditions: Extensive Stage Small Cell Lung Cancer

Summary: this is a randomized, double-blind, multicenter, phase iii clinical study to compare the clinical efficacy and safety of hlx10+ chemotherapy vs placebo+chemotherapy in previously untreated patients with extensive stage small cell lung cancer. eligible subjects in this study will be randomized to arm a or arm b at 2:1 ratio as follows: arm a (hlx10 arm): hlx10 + chemotherapy (carboplatin-etoposide) ; arm b (placebo arm): placebo + chemotherapy (carboplatin-etoposide); the three stratification factors for randomization include: pd-l1 expression level (negative, positive, not available), brain metastasis (yes versus no), age (≥ 65 years versus \< 65 years)


Eligibility criteria:
inclusion criteria: * histologically or cytologically diagnosed with es-sclc (according to the veterans administration lung study group staging system). * no prior systemic therapy for es-sclc * major organs are functioning well * participant must keep contraception exclusion criteria: * histologically or cytologically confirmed mixed sclc. * known history of severe allergy to any monoclonal antibody. * known hypersensitivity to carboplatin or etoposide. * pregnant or breastfeeding females. * patients with a known history of psychotropic drug abuse or drug addiction. * patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

Keywords: extensive stage small cell lung cancer anti-pd-1 monoclonal antibody
interviews and video capture in patients with gm1 gangliosidosis

Conditions: GM1 Gangliosidosis

Summary: gm1 gangliosidosis is a rare disease for which there is a limited understanding of disease progression and meaningful outcome measures. in addition, parents report that clinic-based assessments are not always well-suited to capture all the disease features and other metrics that have an impact on the patient and family. to address the methodological challenges of this small, heterogeneous population, this study will collect patient-specific home-based video data and qualitative interviews with caregivers.

this is a natural history study, for up to 2 years, during which parents or guardians of a child with gm1 gangliosidosis collect video data of patients doing specific daily life activities at baseline and follow-up timepoints throughout the study (3, 6, 12, 18, and 24 months) and/or submit videos taken in the past through a secure smart phone mobile application. the video assessments focus on several hallmarks of gm1 gangliosidosis progression. caregivers participate in qualitative interviews to provide context for the videos and discuss any changes they observe during the study. activity videos will be evaluated by expert clinicians using both clinical global impression of severity (cgi-s) and clinical global impression of change (cgi-c) scales. the caregiver interviews and clinician-rated activities will inform the patient-specific disease trajectories for each hallmark. there is no treatment or intervention associated with this study.

Eligibility criteria:
inclusion criteria: be or have been the parent, legal guardian, or caretaker of a patient with gm1 gangliosidosis with: 1. early infantile gm1 gangliosidosis 2. late infantile gm1 gangliosidosis 3. juvenile gm1 gangliosidosis who can walk with assistance or possesses past videos of when child could walk with assistance 4. early or late infantile gm1 gangliosidosis who has passed away, but is in possession of videos documenting the onset and evolution of disease hallmarks of gm1 gangliosidosis exclusion criteria: gm1 gangliosidosis patient that the caregiver cares for is being treated with any experimental medication in a clinical trial setting.

Keywords: gm1 gangliosidosis landing disease lysosomal storage disease
multicenter prospective trial on hemorrhoids

Conditions: Hemorrhoids

Summary: this study will compare ferguson hemorrhoidectomy and thd in terms of one-year recurrence in a large population (n=492). recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.

this is a multicenter, parallel arm, non-randomized prospective data collection trial comparing ferguson hemorrhoidectomy and thd in terms of recurrence rates at one-year. all subjects will already be scheduled for either ferguson or thd hemorrhoidectomy, the surgery is not part of the research. although a randomized study would control for variation among surgeons, this study design provides the best patient safety since the surgeons will perform the technique they do most frequently. variability in the patient population will be managed with a conservative sample size, which allows for a multivariate analysis of the sample populations if any confounding variables are noted during initial data analyses. in addition, the variability will be minimized with stringent and detailed inclusion/exclusion criteria in terms of hemorrhoidal disease. patients will be enrolled and followed for one year. participating surgeons will be credentialed and each participating surgeon will enroll up to ten consecutive patients. the primary endpoint of this study is to compare ferguson hemorrhoidectomy and thd in terms of recurrence rates at one-year. recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.

Eligibility criteria:
inclusion criteria: patient must be: * at least 18 years-old * able to sign informed consent * presenting with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns at physical examination and scheduled for either ferguson or thd hemorrhoidectomy. exclusion criteria: * any prior anorectal surgery except for conventional office-based interventions (rubber band ligation, sclerotherapy, and infrared coagulation) * prior pelvic radiotherapy * inflammatory bowel diseases * pre-existing fecal incontinence (wexner score5 ≥8) * pre-existing chronic anal diseases * grades iii and iv gynecological and obstetrical trauma per medical history and/or physical examination * connective tissue disorders * subject is pregnant * subject is under incarceration
a virtual heart failure optimization program for guideline directed medical therapy and cardiac rehabilitation

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the goal of this study is to test the impact of a virtual heart failure optimization program on uptake of guideline directed medical therapy, participation in cardiac rehabilitation \& impact on echocardiographic parameters.

this is a single center, prospective pre-post cohort study testing a virtual, multi-disciplinary heart failure optimization program for up-titration of guideline directed medical therapy. this nurse and kinesiologist-led program will start and up-titrate patients on gdmt and offer virtual cardiac rehabilitation over a 3-month period. the investigators hypothesize that this program could safely achieve higher rates of maximally tolerated arni, beta-blocker, mra and sglt2i rates, as well as participation in cardiac rehabilitation among hfref patient participants. the investigators hypothesize that participation will lead to improved left ventricular ejection fraction on echocardiogram.

Eligibility criteria:
inclusion criteria: * hfref (ejection fraction less than 40%) with new york heart association (nyha) class ii or iii symptoms * adults (\>18 years of age), capable of providing informed consent, english-proficient and with access to a telephone exclusion criteria: * patients who are pregnant * patients who who are incarcerated * cardiac transplant patients * patients with left ventricular assist devices
a study of valsartan administered once daily versus twice daily, in patients with stable, chronic heart failure

Conditions: Chronic Heart Failure

Summary: this study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (nyha class ll-lll). the 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. in each of the treatment arms (qd and bid), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. patients remain on their prior chf standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.


Eligibility criteria:
inclusion criteria * males or females aged 18 years or older * diagnosis of chronic heart failure (chf), in nyha class ll-lll beginning at least 3 months prior to visit 1 * patients must remain on their prior standard care chf therapy exclusion criteria * diagnosis of severe hypertension (sbp\>180 and dbp\>110 mm hg) * right heart failure due to pulmonary disease * presence of rapidly deteriorating heart failure * mi or cardiac surgery, including ptca within 3 months of visit 1 * unstable angina or coronary artery disease likely to require cabg or ptca * other protocol-defined exclusion criteria may apply.

Keywords: valsartan, chronic heart failure,
a comparison of survey methodologies to elicit sensitive information from adolescents in urban india

Conditions: Unmarried Male and Female Adolescents in the Age Group 15-19 Years in Pre-Identified Slums in Delhi, India

Summary: the goal of this study is to use three different survey methodologies to evaluate whether adolescents report on their knowledge, attitudes and behaviors on sexual and reproductive health issues differently based on the manner in which questions are asked.

specific aims and research questions aim 1: to compare adolescents' levels of reporting of their own reproductive health knowledge, attitudes and behaviors using three survey methodologies: (1) face-to-face interview (2) audio-casi (computer assisted self interview) and (3) a culturally appropriate interactive methodology. the following hypothesis will be tested: • overall, adolescents will be more likely to divulge their own reproductive knowledge, attitudes and behaviors with audio-casi and the interactive method as compared to face-to-face interviews. levels of knowledge, attitudes and behaviors will vary by education, age and gender. aim 2: to compare respondents' levels of comfort, accuracy and honesty with the survey methodologies (i.e. face to face, audio-casi and interactive methodology) to their reporting of knowledge, attitudes and behaviors related to sexual and reproductive health.

Eligibility criteria:
inclusion criteria: unmarried male and female adolescents in the age group 15-19 in pre-identified slums in delhi, india exclusion criteria: -
registry for patients undergoing penile prosthesis implantation for male erectile dysfunction

Conditions: Erectile Dysfunction

Summary: prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using penile prosthesis implants (ppis).

this will be a prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using penile prosthesis implants (ppis). the data collection will be undertaken from multiple centres in europe. the participation will be by open invitation from the european association of urology (eau) section of genitourinary reconstructive surgeons (esgurs) to all its members, along with other urologists undertaking these procedures. there will be no restriction on the number of patients enrolled per centre as long as they are consecutive. the aim is to have a long term collection of the dataset from as many centres as possible. an initial assessment for the robustness of the data collection and first clinical evaluation of the data collected will be performed 1 and 2 years after recruitment of the first patient by a nominated steering committee. thereafter, the evaluations will be performed every 2 years until the end of registry (10 years after the first patient was enrolled).

Eligibility criteria:
inclusion criteria: * male patient undergoing a surgical penile prosthesis implant for treatment of erectile dysfunction. * participant is willing and able to give informed consent for participation in the registry and is able to complete the questionnaires. exclusion criteria: * participating center is unable to contribute consecutive patients.

Keywords: penile prosthesis implant