Kornimate/medical-research-clean huggingface dataset:
trial to evaluate tibolone in the treatment of osteoporosis (p06468)

Conditions: Osteoporosis

Summary: tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected to be effective in preventing fractures in osteoporotic women. tibolone could be more acceptable for long-term use, in particular since it does not induce a regular withdrawal bleed. the objective of this trial is to compare placebo and tibolone, a steroid with tissue specific activity, in the prevention of spinal fractures in women meeting the who criteria for osteoporosis or who have asymptomatic vertebral fractures.


Eligibility criteria:
inclusion criteria: * voluntary written informed consent, and who were willing and able to make reasonable efforts to observe all clinical trial requirements were to be enrolled * subjects were to be postmenopausal (naturally or surgically) women, from 60 to 85 years of age (inclusive) at entry * screening bmd of the total hip and/or spine had to be equal to or lower than 2.5 sd t-score for subjects without an asymptomatic fracture or equal to or lower than -2.0 sd t-score for subjects with an asymptomatic fracture * subjects were to have a body mass index (bmi) = 34 kg/m\^2. exclusion criteria: subjects with any of the following conditions were not to be enrolled into the trial: * recent acute vertebral fracture (diagnosed within the last year) documented by spinal radiograph requiring medication for osteoporosis treatment, in the judgment of the investigator * more than two prevalent asymptomatic vertebral fractures at baseline * screening bmd of the total hip or spine lower than -4 sd t-score * unsuitable anatomy on spinal radiographs (lumbar and thoracic vertebrae) e.g., excessive scoliosis * not ambulatory * history or presence of any malignancy within the past five years except for nonmelanoma skin cancer. subjects with ever history of ovarian cancer or estrogen dependent tumors particularly breast or endometrial cancer were to be excluded * trans vaginal ultrasound (tvus) endometrial double wall thickness \>4 mm * unexplained abnormal vaginal bleeding in the past year prior to screening * abnormal cervical papanicolaou (pap) smear (including low grade squamous intraepithelial lesion (lsil), high grade squamous intraepithelial lesion (hsil), atypical squamous cells of undetermined significance (ascus), atypical glands of undetermined significance (agcus)) * mammography finding that was suspicious of malignancy * bone disease other than osteoporosis such as paget's disease, osteomalacia, hyperparathyroidism, or bone metastases * treatment with anabolic steroids, calcitonin, raloxifene, tamoxifen, or calcitriol within the last six months prior to screening bmd or spinal x-ray measurements. * treatment with systemic estrogen and/or progestin within the last three months prior to screening bmd or spinal x-ray measurements (occasional use of estriol containing vaginal cream was allowed) * treatment with bisphosphonates for one month or more within the last year * ever use of estrogen and/or progestin containing implants
evaluation of the effectiveness of endoscopic "rendez-vous" technique foresophageal reconstructions for the treatment of a total and extensive disruption of the esophagus

Conditions: Esophageal Disruption; Esophageal Obstruction

Summary: complete esophageal obstructions leads to definitive fasting. the rendez-vous endoscopic approach had already been described for complex stenoses but never for disruption with loss of tissue and ses. patients and methods: this is a retrospective observationnal study about patients referred for complete esophageal disruption and classified in two groups: 1/ long disruption (\> 5cm), after caustic ingestion or due to an esophageal stripping during sems removal; 2/ short disruption (\< 5cm), consecutive to radiation therapy. all the procedures are performed according the anterograde retrograde approach, using co2 and under x-rays guidance. we report the characteristeristics of the procedures, the efficacy, the time before discharge and refeeding, the complications, and the follow-up, especially the number of dilatation sessions for each group. the hypothesis is that anterograde retrograde endoscopic technique is safe and effective for the management of esophageal disruptions in patients for which the surgical treatment confers a high risk of morbidity and mortality.


Eligibility criteria:
inclusion criteria: * esophageal disruption with or without loss of ses exclusion criteria: * esophageal complex stenosis * mediastinitis * severe sepsis * coagulation abnormalities * contra-indications to general anesthesia

Keywords: esophageal disruption anterograde-retrograde endoscopy rendez-vous technique notes recanalization dilatations stenting radiation therapy head and neck carcinoma
effects of sage extracts on cognitive function during aerobic exercise

Conditions: Healthy

Summary: extracts of sage have been reported to interact with central nervous system (cns) mechanisms relevant to cognitive performance but, to date, no trial has clearly demonstrated the possible effects in healthy individuals in fatiguing conditions. the current study investigates the effects of this supplementation in healthy males and females versus placebo on cognition, heart rate and perceived exertion, during a fatiguing cycling exercise.

healthy males and females will be tested in fresh and fatiguing conditions to mimic individuals at the beginning or during a competition where cognitive function are important for decision making for example. tests will be conducted during the warm-up (fresh), during fatiguing situations (during two consecutive 10-minutes pedaling exercises) and during recovery. tests will include a reverse digit memory test (from 3 to 7 digits), a stroop test, a simple reaction time test. moreover, heart rate and rating of perceived exertion will be quantified.

Eligibility criteria:
inclusion criteria: * body mass index lower than 27 and waist size lower than 94 cm * physical activity higher than 3 hours a week * written informed consent exclusion criteria: * more than 12 hours training a week * asthmatic, smokers or under medicinal drugs * dietary supplement, sports drink, special dietary food or functional food, of any kind, liable or presented as liable to enhance physical performances

Keywords: cycling cognition sage memory fatigue
rickets device - feasibility study

Conditions: Rickets

Summary: on a daily basis many (prematurely born) newborn are subjected to different urine collecting techniques to study biochemical abnormalities. neonatology nurses and pediatricians are looking for a better and less invasive manner to collect urine in these vulnerable patients. we hypothesise that the urine collecting device as presented in this protocol is less invasive and has good functional abilities to collect urine in these newborns objective of the study: clinical feasibility of the urine collection device, indicated by staff and parents. study design: the study will be an open label, clinical feasibility study, of the urine collection device. during a period of 6 months, 30 feasibility tests will be performed. study population: prematurely born newborns, admitted to the neonatology unit of the department of pediatrics at rijnstate hospital arnhem.


Eligibility criteria:
inclusion criteria: * neonates admitted to the neonatology unit of the paediatrics department of rijnstate hospital medical indication for urine testing for calcium, phosphate and creatinine levels informed consent from parents exclusion criteria: * no informed consent * defective skin in genital region * three previous tests in the same subject

Keywords: prematurely born newborns urine collecting device
ultrasound wave therapy for post-stenotic microvascular remodeling

Conditions: Renal Artery Stenosis

Summary: researchers are evaluating a noninvasive treatment with ultrasound waves for atherosclerotic renal artery stenosis (aras).

investigators will study 30 patients with aras randomized to swt or sham (n=15 each) twice a week over 3 weeks. we will measure before and again 3 months after a 3-wk regimen renal cortical and medullary perfusion and function (multi-detector computed tomography \[mdct\]), oxygenation, and fibrosis (magnetic resonance imaging \[mri\]), urinary and plasma levels of renal injury markers, systemic endothelial function, and heart rate variability, an index of sympathetic activation.

Eligibility criteria:
inclusion criteria * patients are between ages 40 and 80 years old. * patients with hypertension (systolic bp\> 155 mm hg) and/or requirement for two or more antihypertensive medications for more than 4 weeks, no restrictions on antihypertensive agents, although loop diuretics may be changed to diluting site agents (e.g. hydrochlorothiazide, indapamide, metolazone) for two weeks prior to study. * patients have serum creatinine ≤2.2 mg/dl. * patients have no contraindications to angiography: severe contrast allergy. * patients have no contraindications to no-contrast mr evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia. * patients have the ability to comply with protocol * patients are competent and able to provide written informed consent exclusion criteria * patient have serum creatinine \>2.2 mg/dl * aras in a solitary kidney * patients have clinically significant medical conditions within the six months before swt treatment: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient. * uncontrolled hypertension (systolic bp \>180 mmhg despite therapy). * pacemaker, implantable defibrillator or other contraindication to mri * inability to comply with breath-hold for 20 seconds * any active malignancy and undergoing therapy * patients are pregnant. * kidney or ureteric stone that may affect the effect of swt. * another known acute or chronic kidney disease * local inflammation or infection over treatment areas. * bleeding disorders. * federal medical center inmates. * latex allergy
dietary control of type 2 diabetes: low-carbohydrate mediterranean diet versus low-fat diet

Conditions: Type 2 Diabetes Mellitus

Summary: the major environmental factors that increase the risk of type 2 diabetes, presumably in the setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent overweight and obesity. the high rate of weight regain has limited the role of lifestyle interventions as an effective means of controlling glycemia long term. the aims of the present study were: 1) to compare the effectiveness and safety of two nutritional protocols - namely low-carbohydrate mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive overweight patients with type 2 diabetes mellitus. the primary aim of the study was the effect on hemoglobin a1c levels; secondary aims were time to introduction of the first hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ada goals for risk factors (hba1c, blood pressure, ldl-cholesterol, percentage of patients with hba1c \< 7%.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (ada criteria) * bmi (body mass index) \> 25 kg/m2 * hemoglobin a1c (hba1c) \< 11%; blood pressure \< 160 (systolic) and 100 (diastolic) mm hg * triglyceride levels \< 500 mg/dl. exclusion criteria: * pregnancy or breast-feeding * previous use of insulin or oral antidiabetic drugs * investigational drug within the previous 3 months * use of agents affecting glycemic control (systemic steroids and weight loss drugs) * patients with history of alcohol or illicit drug abuse * patients with liver enzymes higher than three times the upper limit of normal * serum creatinine \> 1.4 mg/dl.
mass spectral fingerprinting in lung cancer

Conditions: Lung Cancer

Summary: to answer the question whether a disease specific profile of breath in patients with lung cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility criteria:
inclusion criteria: * confirmed lung cancer based on cytological or histological analysis. * group a: any type of lung cancer eligible for surgical resection (up to tnm stage iiia). * group b: any type of lung cancer (small-cell carcinoma, non-small-cell carcinoma) not amenable for surgical resection. * group c: matched controls. * age between 18 and 85 years at study entry exclusion criteria: * another 'active' secondary malignant disease (e.g. breast cancer, colon carcinoma) in group a and b, presence of any active malignant disease in group c (based on personal information). * acute inflammatory disease (e.g. common cold) within the last 4 weeks. * any other acute lung disease which affects breath measurements * acute or chronic hepatic disease. * renal failure or renal replacement therapy.

Keywords: exhaled breath mass spectrometry fingerprinting
gallium-68 psma-11 pet in patients with biochemical recurrence

Conditions: Prostate Cancer

Summary: the investigators are imaging patients with prostate cancer using a new pet imaging agent (ga-68-psma-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

imaging and staging of prostate cancer is critical for surgical and treatment planning. patients with suspected metastatic prostate cancer will be imaged using gallium-68 labeled psma-11 in order to demonstrate its utility. the investigators plan to utilize this data to obtain further approvals of the ga-68-psma-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. in the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (ppv) on a per-patient and per-region-basis of 68ga-psma-11 pet for detection of tumor location confirmed by histopathology/biopsy.

Eligibility criteria:
inclusion criteria: * histopathological proven prostate adenocarcinoma. * rising prostate-specific antigen (psa) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). * post radical prostatectomy (rp) - american urological association (aua) recommendation * psa greater than 0.2 ng/ml measured more than 6 weeks after rp and, * confirmatory persistent psa greater than 0.2 ng/ml * post-radiation therapy -astro-phoenix consensus definition * nadir + greater than or equal to 2 ng/ml rise in psa * karnofsky performance status of greater than 50 (or eastern cooperative oncology group (ecog) /world health organization (who) equivalent). * age \> 18. * ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: * investigational therapy for prostate cancer. * unable to lie flat, still or tolerate a pet scan. * prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer. * contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (note: this exclusion criteria can be removed if furosemide is omitted as part of the pet imaging protocol if a second-generation scatter correction is available for the used pet device).
study of hpv specific immunotherapy in participants with hpv associated head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Cancer

Summary: this is a phase i/iia, open-label study to evaluate the safety, tolerability, and immunogenicity of ino-3112 dna vaccine delivered by electroporation (ep) to participants with human papilloma virus (hpv) associated head and neck squamous cell cancer (hnscc).

this is a phase i/iia, open-label, study to evaluate the safety, tolerability, and immunogenicity of ino-3112 \[6 mg of vgx-3100 (2 separate dna plasmids respectively encoding e6 and e7 proteins of hpv 16 and hpv 18) and 1 mg of ino-9012 (dna plasmid encoding human interleukin 12)\] delivered by electroporation (ep) in up to 25 (twenty-five) participants with hpv positive head and neck cancer. the immunotherapy was studied in the following two groups of participants: 1. participants who received immunotherapy before and after definitive surgery (cohort i) 2. participants who received immunotherapy at least 2 months after chemoradiation therapy (cohort ii).

Eligibility criteria:
inclusion criteria: 1. signed and dated written ethics committee approved informed consent. 2. age ≥18 years. 3. histologically confirmed hpv-positive (as assessed by p16 ihc or oncogenic hpv ish or pcr) mucosal squamous cell head and neck cancer: * for pre-surgical participants, p16 positivity must be confirmed prior to the first dose. * for participants post-chemoradiation, hpv 16 and hpv 18 positivity must be confirmed prior to the first dose. 4. adequate bone marrow, hepatic, and renal function. anc (absolute neutrophil count) ≥ 1.5x109 cell/ml, platelets ≥75,000 cells/mm3, hemoglobin ≥9.0 g/dl, concentrations of total serum bilirubin within 1.5 x upper limit of normal (uln), (aspartate aminotransferase) ast, (alanine aminotransferase) alt within 2.5x institutional uln, (creatine phosphokinase) cpk within 2.5 x uln. 5. ecog (eastern cooperative oncology group) performance status of 0-1. exclusion criteria: 1. anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids). 2. any concurrent condition requiring the continued use of systemic steroids (\>10 mg prednisone or equivalent per day) or the use of immunosuppressive agents. all other corticosteroids must be discontinued at least 4 weeks prior to day 0 of treatment. 3. administration of any vaccine within 6 weeks of enrollment.

Keywords: head and neck squamous cell cancer papillomavirus
a phase 1 study of bpi-371153 in subjects with advanced solid tumors or relapsed/refractory lymphoma

Conditions: Advanced Solid Tumor; Lymphoma; NSCLC; HCC

Summary: a first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (mtd) and establish the recommended phase 2 dose (rp2d) of bpi-371153, a pd-l1 inhibitor, in patients with advanced solid tumors or relapsed/refractory lymphoma.


Eligibility criteria:
inclusion criteria: * dose escalation phase: age ≥18 and ≤65 years, male and female patients; dose expansion phase: age ≥18, male and female patients; * eastern cooperative oncology group (ecog) performance status (ps) 0-1; * dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding hcc patients) or relapsed/refractory lymphoma, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists; * dose expansion phase: histologically or cytologically confirmed locally advanced or relapsed/metastatic non-driver mutation nsclc, relapsed/refractory lymphoma, hcc with child-pugh a or b(≤ 7 points), or other diagnosed solid tumor patients who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists; * evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per recist v1.1( for other diagnosed solid tumos excluding hcc), mrecist(for hcc) or lugano 2014(for lymphoma); * adequate organ function; exclusion criteria: * dose escalation phase: prior immune checkpoint inhibition with anti-programmed cell death-1 (pd1)/programmed death ligand-1(pd-l1) or programmed death ligand-2(pd-l2) therapy; * dose expansion phase: prior immune checkpoint inhibition with anti-programmed cell death-1 (pd1)/programmed death ligand-1(pd-l1) or programmed death ligand-2(pd-l2) therapy within 28 days prior to treatment. subjects with a history of a grade 3 or higher immune-related ae from prior immunotherapies; * prior other specific t cell targeting agents; * use of systemic or absorbable topical corticosteroids therapy(≥ 10 mg/day prednisone or equivalent) two weeks prior to start of treatment. * inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong cyp3a inhibitor or inducer, and vaccine; * patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic cns metastasis, other malignant tumors, autoimmune disease, ild, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc; * pregnancy or lactation; * other conditions considered not appropriate to participate in this trial by the investigators.
quality of life comparison in patients with different types of alopecia

Conditions: Alopecia; Quality of Life

Summary: hair loss is a frequent cause of patient consultation in dermatology. it is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences. numerous studies have assessed the impact of some types of alopecia on patients' quality of life. one study compared the quality of life in patients with scarring alopecia with patients of non-scarring alopecia. no studies have compared quality of life between the different types of scarring alopecia nor different types of non-scarring alopecia. however, none have assessed the impact on the patient partner quality of life. in addition, few treatments for alopecia are covered by national health insurance in france. the main objective is to compare the impact on the quality of life in different types of alopecia. by using the average scores of the questionnaire dermatology life quality index (dlqi) for each type of alopecia.


Eligibility criteria:
inclusion criteria: * patients affiliated to social security * patients able to understand and fill out a questionnaire * patients over 18 years old * patient consulting in the dermatology department of amiens university hospital for a primary alopecia exclusion criteria: * minors * patients under guardianship, deprived of liberty * scalp affections other than alopecia * secondary alopecia

Keywords: alopecia quality of life partner