Kornimate/medical-research-clean huggingface dataset:
bmd alterations and bone and muscle parameters during menstrual cessation with gnrh

Conditions: Endometriosis; Bone Density; Muscle; Bone Metabolism

Summary: the investigators aim to investigate the effect of menstrual cessation in women with endometriosis treated with gnrh analogs for 6 months on bone mineral density and bone and muscle metabolism parameters and subsequently the effects of menstrual restoration after gnrh analogs discontinuation on the above measured parameters

prospective, open-label, controlled 12month observational study premenopausal women with surgically verified endometriosis will receive goserelin 1 injection per month for 6 months. subsequently goserelin will be discontinued and patients will be monitored for another 6 months after menstrual restoration. age- and bmi-matched premenopausal, health women will serve as controls. controls will receive no treatment.

Eligibility criteria:
inclusion criteria: premenopausal women with surgically verified endometriosis exclusion criteria: 1. secondary osteoporosis 2. diseases or conditions that could affect bone and/or muscle metabolism 3. any medications that could affect bone and/or muscle metabolism

Keywords: endometriosis bone mineral density myokines sclerotin periostin
a window of opportunity trial of intratumoral injection of copaxone® in patients with percutaneously accessible tumors

Conditions: Cutaneous Squamous Cell Carcinoma; Squamous Cell Carcinoma; Basal Cell Carcinoma

Summary: the investigator believes that injecting copaxone into tumors will help participants immune system fight cancer. this has been studied in mice and has shown encouraging results. copaxone is a safe medication currently used to treat multiple sclerosis (ms) and has very few side effects. to be considered for this trial a tumor must be easy to be injected and must be at least the size of a pea. participants will be closely monitored for any side effects. tissue from before surgery will be compared to tissue after the treatment and surgery to be checked for immune response and anti-tumor effects.


Eligibility criteria:
inclusion criteria: * ability of participant or legally authorized representative (lar) to understand this study, and participant or lar willingness to sign a written informed consent. * have confirmed diagnosis of squamous cell cancer or cutaneous squamous cell cancer or basal cell carcinoma. * have one or more tumors measuring at least 5 mm in diameter. * no prior therapy for this malignancy. * women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal and barrier method of birth control) prior to study entry, for the duration of study participation until the end of study treatment. if a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately. * men of child-bearing potential must not father a child or donate sperm while on this study until the end of study treatment. * physician feels the patient is medically fit for the trial. exclusion criteria: * current or anticipated use of other investigational agents while participating in this study. * pregnant or breast feeding. there is a potential for congenital abnormalities and for this regimen to harm breast feeding infants (if applicable) planned treatment with chemotherapy and/or radiation therapy prior to standard of care surgery. concurrent treatment with anti-cancer therapy is not allowed. * hypersensitivity to copaxone® or glatiramer acetate, mannitol, or any component of the formulation. * a known condition that leads to immunosuppression such as acquired immunodeficiency syndrome (aids) or concurrent use of immunosuppressive therapy.

Keywords: copaxone window of opportunity trial
sentinel node in colon cancer

Conditions: Colon Cancer

Summary: more than 20% of patients operated on for colon cancer without node metastasis will develop visceral metastases. the purpose of the study is to determine sentinel lymph nodes with two methods: blue injection and isotopic detection. sentinel nodes will then be analyzed by immunohistochemy to detect micrometastases. no adjuvant therapy will be proposed to the patient if there are only node's micrometastases and survival will be analyzed in regard to the presence of these micrometastasis.


Eligibility criteria:
inclusion criteria: * adult * colon cancer * open surgery exclusion criteria: * emergency surgery * metastases

Keywords: sentinel node isosulphan blue isotopic detection survival
phase 3 efficacy and safety study of cd07805/47 topical gel in subjects with persistent facial erythema

Conditions: Erythema

Summary: the purpose of this study is to compare the efficacy and assess the safety of cd07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema


Eligibility criteria:
inclusion criteria: * male or female, who is at least 18 years of age or older at screening visit. * presence of chronic persistent vascular facial erythema for ≥ 3 months by history. * a clinician's erythema assessment (cea) score of ≥3 at screening and at pre-dose (t0) on baseline/day 1. * a patient self assessment (psa) score of ≥3 at screening and at pre-dose (t0) on baseline/day 1. exclusion criteria: * more than 2 facial inflammatory lesions (papules, pustules, and nodules). * presence of areas of significant scaling or crusting on the face. * presence of psoriatic lesions on the face. * presence of any other dermatological condition of the face that, in the opinion of the investigator, may significantly interfere with the interpretation of the clinical trial results.
effect of massage therapy in cortisol level

Conditions: Asymptomatic State

Summary: this study evaluates the effect of a single session of massage therapy in salivary cortisol level. all participants were assessed on three conditions: massage session, rest in supine position listening music, and under normal working conditions. the hypothesis of the investigators is that the effect of the massage action in reduction of cortisol is superior to only rest.

several studies have postulated that one of the physiological markers of the effect of massage therapy is to reduce the level of cortisol, the "stress hormone". however it is not clear whether the effect is due to the manual action on the skin, or only by the relaxation induced rest. therefore the variation of salivary cortisol in both conditions, and also in everyday working conditions was compared. cortisol has a circadian cycle, with a maximum value upon awakening, which decreases during the morning; therefore a sample of saliva (in salivette tube) it was collected in the three experimental conditions at the same hour time in the morning: 8:45(after intervention), and 9:30 and 10.30 (both, before).

Eligibility criteria:
inclusion criteria: * office/administrative workers of faculty of medicine, university of chile. exclusion criteria: * musculoskeletal disease or injury in spine. * body mass index over 35. * smoking (over three cigars at day) * depression. * pregnancy * corticosteroid treatment. * skin wound or disease. * intolerance to the prone position.

Keywords: massage stress salivary cortisol
safety and feasibility of exonet

Conditions: Stroke; Cerebral Vascular Accident

Summary: the purpose of this study is to evaluate the safety, feasibility, and preliminary efficacy of the exonet passive robotic device. it will provide upper-extremity gravity compensation for therapeutic movement retraining in the chronic post stroke patient population.

the exonet, a passive robotic solution that provides a soft, biomimetic, and elastic alternative to robotics that embodies intelligence within the mechanical design. several groups have been exploring performance enhancement using springs with custom-tuned parameters via optimization. here, it is possible to have a simple reconfigurable system that can not only assist performance, but can also make training easier, faster, and more complete. this contribution has the potential to be clinically significant for rehabilitating neurologically impaired individuals because this proposal will investigate how motor learning can be facilitated through novel assistive technology. the primary objective of this study is to evaluate the safety, feasibility and efficacy using the exonet. specifically, investigators want to see if the exonet tuned to gravity support will lead to a reduction in bicep muscle activity and an increase in range of motion. to accomplish this aim, we plan to have participants perform reaching, arm elevation and flexion task exercises wearing the exonet. to achieve these goals, we will use a wearable activity tracker (migo), to detect the number of activities performed, a wearable surface emg system (delsys) on the bicep muscles and a markerless system called the kinect (version 2) to collect distribution of motion. investigators hypothesize that individuals with post-stroke arm movement deficits treated with exonet gravity compensation will improve their arat measures more than controls receiving a sham treatment. secondarily, treated subjects will improve in other clinical metrics and will make more movements than controls.

Eligibility criteria:
inclusion criteria: 1. ischemic or hemorrhagic stroke (8 months post stroke) 2. available medical records and radiographic information about lesion locations 3. hemiparesis 4. some degree of both shoulder and elbow movement capability 5. a "moderate" impairment (fugl-meyer score between 15-50) exclusion criteria: 1. individuals under the age of 18 2. bilateral paresis 3. shoulder pain and/or articular rigidity on the upper limb joint 4. spasticity (modified ashworth scale of 2) 5. botox injection to the affected upper extremity within the previous 4 months 6. aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment

Keywords: upper extremity rehabilitation stroke
evaluation of mesh integration and mesh contraction after open preperitoneal inguinal hernia repair using a memory ring containing device

Conditions: Unilateral Inguinal Hernia

Summary: the aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (rebound hrd™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (belgian) prospective trial. patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a ct scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.


Eligibility criteria:
inclusion criteria: * elective repair for a primary unilateral inguinal hernia or * elective repair for a recurrent unilateral inguinal hernia after non-mesh repair exclusion criteria:

Keywords: inguinal hernia
a study evaluating the value of 68ga-pentixafor pet imaging in the staging of hematological tumor, and comparing it with 18f-fdg pet/ct imaging

Conditions: Hematological Malignancies

Summary: this is a prospective, open-label, single-center clinical study targeting hematological malignancies. 120 patients with a confirmed by pathology of non-hodgkin's lymphoma or myeloma were included. qualified subjects will undergo 18f-fdg pet/ct and 68ga-pentixafor pet/ct examination. the aim is to to investigate whether 68ga-pentixafor pet imaging can be used as a reliable complement to 18f-fdg pet imaging for clinical staging, treatment response evaluation, and re-staging of patients with hematological malignancies.


Eligibility criteria:
inclusion criteria: ages 18 to 75 years old confirmed by pathology with nhls or myeloma willing and able to follow the study protocol. exclusion criteria: children, pregnant or lactating women severely impaired liver and kidney function (alanine aminotransferase \> 8-10 times the upper limit of normal, serum creatinine 186-442 umol/l) with a history of allergy to contrast media or other drugs

Keywords: 68ga-pentixafor hematological malignancies 18f-fdg staging
meals on wheels, the effect of a home food-delivery service for cancer patients

Conditions: Lung Cancer; Ambulant; Malnourished

Summary: the overall objective of the study is to investigate the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished patients suffering from cancer on various endpoints.

despite the fact that nutritional deterioration has been associated with patients' functional impairment, the effect of individualized nutritional support or counselling to outpatients, focussing on ordinary food, have not yet been thoroughly explored (ravasco p. et al. 2007). a few studies have investigated the effect of nutritional counselling on quality of life (qol) in cancer patients after discharge (ovesen et al. 1993, persson et al. 2002, isenring et al. 2004, ravasco et al. 2005a, ravasco et al. 2005b). however, there is to our knowledge not conducted any studies examining the effect of home delivered meals on qol and other endpoints in outpatients suffering from cancer. the overall objective of the study is to measure the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished outpatients diagnosed with lung cancer. the intervention diet will consist of optional protein- and energy-dense main and in-between-meals. there will be 22 different main meals and 13 in-between meals to choose between. the meals are prepared by the nordic kitchen of copenhagen university hospital herlev. the offered main meals will consist of a selection of warm dishes taken from the ordinary menu. the in-between meals are a collection of the delights of herlev (dishes previously shown to increase dietary intake among in-patients). the food will be delivered to the participants' home 3 times per week, and participants can order one warm dish and ad libitum in-between meals for each day.

Eligibility criteria:
inclusion criteria: * have a nutritional risk score ≥ 3 according to nrs-2002 (kondrup j. et al. 2003) * be diagnosed with lung cancer * have a life expectancy \> 12 weeks * not plan to loose weight or go on a diet * not plan to go on vacation for \> 2 weeks during the study period * live at their own home * live ≤ 25 km from the hospital * be able to read, write and understand danish exclusion criteria: * receives food from a food-delivery service * have food allergies or intolerance * exclusively receives enteral or parenteral nutrition * suffers from cognitive impairment e.g. dementia * is terminal

Keywords: cancer food-delivery nutritional intervention quality of life outpatients
clinicopathological characteristics of colon cancer in young age

Conditions: Colo-rectal Cancer; Molecular Pathway Deregulation

Summary: a study on the characteristics of colorectal cancer by age and sex.

the investigators aimed to investigate the prognosis according to sex and age by analyzing the clinical, pathophysiological, and molecular characteristics of colorectal cancer (crc), and to find the factors influencing the prognosis of crc.

Eligibility criteria:
inclusion criteria: * patients treated after being diagnosed with colorectal cancer exclusion criteria: * patients under age of 18 years, or patients who cannot choose whether to participate or not * patients who refuse to participate in the study

Keywords: colorectal cancer prognosis sex difference
aids and cancer specimen bank (acsb)

Conditions: Kaposi's Sarcoma AIDS Related; Kaposi's Sarcoma Classical; Non-Hodgkin's Lymphoma; HEMATOPOIETIC SYSTEM; Cancer; AIDS

Summary: the purpose of this study is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with aids and non-aids associated malignancies. the national cancer institute has set up a bank for tissues and biological fluids from hivpositive and hiv-negative individuals in order to have specimens available for scientists studying malignancies associated with hiv disease.

the overall goal of the aids and cancer specimen bank is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with aids and non- aids associated malignancies. these specimens will be banked and linked to a clinical data set so that experimental results obtained by analysis of specific specimens can be linked to relevant clinical data. contents of the acsb will be made available to researchers through an application to the national cancer institute. strict patient confidentiality protection guidelines are in place for all specimens in the acsb. the objective of this protocol is to obtain clinical specimens from potential participants in clinical trials conducted by the aids malignancies consortium, and from other patients with and without hiv infection, who have aids-associated malignancies.

Eligibility criteria:
inclusion criteria: * patient \> 18 years of age * suspected or confirmed aids-associated malignancy with or without hiv infection * will obtain fresh tissue and/or biological fluids * patient signed the correct version of the informed consent exclusion criteria: * n/a

Keywords: kaposi's sarcoma aids related kaposi's sarcoma classical non-hodgkin's lymphoma hematopoietic system cancer aids
ivus controlled stenting

Conditions: Coronary Angioplasty and Stenting; Single de Novo Coronary Artery Stenoses

Summary: stent placement is now widely accepted to improve the results of angioplasty (an operation to widen the blood vessel) and decreasing the need for further surgery. despite their worldwide acceptance, stent usage is still limited by renarrowing which occurs within the stent (restenosis) in some patients within the first six months. in addition there still exists a small risk of heart attacks soon after the stent is placed. the purpose of this study is to test the safety and tolerability of trying to place the stents using a different strategy of using low pressure oversized balloon inflations as opposed to the usual high pressure balloon inflations. this may reduce injury to the artery and reduce the chance of renarrowing of the stent. in order to ensure this is a safe and effective way of performing the procedure the investigators intend to use an intravascular ultrasound (ivus) catheter to look from inside the artery at the stents. ivus has proven to be the best way of ensuring optimal stent placement. primary hypothesis: stents will be equally well expanded and apposed using a strategy of oversized stenting at normal inflation pressures ( \< 10 atmospheres ) as compared to high pressure inflation (≥14 atmospheres) as guided by intravascular ultrasound imaging. secondary hypothesis: there will be no difference in acute clinical endpoints (death, myocardial infarction, urgent revascularisation or stent thrombosis) using a strategy of oversized stenting at normal inflation pressure as compared to high pressure inflation. tertiary hypothesis: if the above is shown to be true the investigators would hope to expand the study in order to reveal a decrease in stent restenosis using a strategy of lower pressure balloon inflations. the investigators will assess the deployment characteristics of drug eluting versus bare metal stents


Eligibility criteria:
inclusion criteria: * patients who are scheduled for a coronary angioplasty and stenting * single de novo artery stenosis are eligible for this study * target lesion needs to be less than 30mm long and located in a vessel more than 2.5 mm in diameter exclusion criteria: * contraindication to antiplatelet therapy; * ostial lesion; * excessive vessel tortuosity; * lesion at a significant bifurcation (subbranch ≥ 2mm in diameter); * suspected intracoronary thrombus.

Keywords: patients scheduled to undergo coronary angioplasty and stenting because of symptoms related to a single de novo coronary artery stenoses
trial of benefit finding in caregivers: the building resources in caregivers (bric) study

Conditions: Quality of Life; Psychological Distress

Summary: a randomised controlled trial that will compare the effects of a brief benefit -finding writing intervention with an active control condition on quality of life and psychological health among informal caregivers.

a double-blind, randomized controlled parallel group study design with an equal 1:1 allocation ratio will be employed. this study will compare the effect of a brief benefit finding writing intervention with a control condition among caregivers. caregivers currently caring for people with mental and physical disabilities will be randomised into a two-week, a) a benefit writing group or b) a control writing group. caregivers will complete self-report measures relating to their care-recipient and themselves (e.g., illness type, and sociodemographics) and psychometric measures of benefit finding (primary outcome), psychological distress and quality of life(secondary outcomes). these will be assessed via online software at baseline, immediate post-test and at 3 month follow-up. additionally, expectations and fidelity indices will be assessed and qualitative commentary on participation experiences gathered.

Eligibility criteria:
inclusion criteria: * must be over the age of 18 * must identify as caring for a family member, friend or relative * must be living in ireland exclusion criteria: * if the person cared for is living in institutional care

Keywords: caregiving benefit finding writing intervention
clinical performance of two commercial, daily disposable contact lenses

Conditions: Refractive Errors; Ametropia; Myopia

Summary: the purpose of this study is to compare the clinical performance of dailies total1 ( dt1) contact lenses with infuse contact lenses.

subjects will wear two products and be expected to attend 3 office visits. the individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

Eligibility criteria:
key inclusion criteria: * habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day; * at least 3 months of contact lens wearing experience; * less than or equal to 0.75 diopter (d) astigmatism in each eye; * best corrected visual acuity (bcva) better than or equal to 20/25 in each eye. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * current/previous dailies total1 and/or infuse habitual lens wearer; * monovision and/or multifocal lens wearer; * routinely sleeps in habitual contact lenses. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses