Kornimate/medical-research-clean huggingface dataset:
effect of muscle strengthening training in adults with fontan circulation

Conditions: Congenital Heart Disease; Univentricular Heart

Summary: aim: to evaluate the effect of muscle strengthening exercise training in adults with fontan circulation compared to healthy controls. hypothesis: adults with fontan circulation have a relatively lower effect of muscle strengthening exercise training compared to healthy controls.

10 adults with fontan circulation will be recruited from the clinic specialised in adults with congenital heart disease at norrlands universitetssjukhus. in addition, 10 age- and sex matched controls will be recruited. the sample size is estimated according to a previous study with the same primary outcome. we estimate that 7 patients and 7 controls are needed in the study and plan to enrol 10 patients and 10 controls in case of any drop outs. muscle tests will be performed at baseline. based on the results from the muscle tests, an individualised muscle training exercise protocol will be designed and the participants will be working out at a gym during 10 weeks. after 10 weeks the same tests will be performed to evaluate the effect of the muscle training exercise. in addition to the muscle tests, muscle mass and aerobic exercise capacity will be evaluated with peripheral quantitative computed tomography and cardiopulmonary exercise test respectively. physical activity will be mapped with a validated questionnaire (ipaq) and an accelerometer attached to the participants thigh. any impact on fatigue will be evaluated with a validated questionnaire (mfi-20). all tests and questionnaires will be performed at baseline and at follow-up.

Eligibility criteria:
inclusion criteria: * age minimum 18 years * patients: congenital heart disease (fontan circulation, univentricle heart) * controls: no known congenital heart disease. exclusion criteria: * muscle strenghtening exercise training at regular basis (2 times/week or more) * active disease or other condition that affect exercise training (e.g. rheumatoid arthritis) * cognitive or psychological affection * other conditions that affect independent decision-making competence
pcr based ceus in bi rads 4a nodules

Conditions: PCA; Breast Cancer

Summary: the aim of this study was to investigate the added value of principal component regression (pcr) based contrast-enhanced ultrasound (ceus) for differentiating low risk patients with breast nodules categorized as 4a using the breast imaging reporting and data system (bi-rads).

the aim of this study was to investigate the added value of principal component regression (pcr) based contrast-enhanced ultrasound (ceus) for differentiating low risk patients with breast nodules categorized as 4a using the breast imaging reporting and data system (bi-rads). the study included patients with 4a nodules confirmed by core biopsy and/or surgery. the ceus parameters were assessed and pcr scores were calculated to evaluated the added value in bi-rads 4a nodules.

Eligibility criteria:
inclusion criteria: patients with bi-rads 4a breast lesion exclusion criteria: (i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.
agility training for older adults to improve fall risk factors

Conditions: Age-Related Loss of Skeletal Muscle Mass; Aging; Sarcopenia; Cognitive Decline

Summary: in this randomized controlled trial the effect of 4 months of multi-component (strength, balance, cognition, endurance) exercise training intervention on measures of neuromuscular performance, cognition, and endurance as well as neural adaptations on a central and peripheral level is investigated. 40 subjects are recruited that are generally health and between 60 and 80 years of age. the interventions is based around exercises, where different tasks have to be solved simultaneously rather than serially, as has previously been done.


Eligibility criteria:
inclusion criteria: * willing to be randomized to either arm * ability to travel to the sports facility twice a week * understanding the german language exclusion criteria: * smoking, obesity * history of cardiovascular, pulmonary or chronic inflammatory disease * vision impairments * orthopaedic problems preventing them from participating in an exercise program * history of osteoporosis or recent low trauma fracture * less than two weeks during the intervention period * not have taken part in a structured exercise program more than once a week in the past three months
a phase 1 study evaluating the safety, pharmacokinetics, and pharmacodynamics, of vx-993

Conditions: Pain

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of vx-993 at different doses in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight of more than (\>) 50 kg * nonsmoker or ex-smoker for at least 3 months before the first study drug dose key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption, distribution, metabolism, or excretion other protocol defined inclusion/exclusion criteria may apply.
walking speeds in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a growing body of evidence suggests that in individuals with chronic lung disease their walk speed is related to their daily function and quality of life. it is possible to assess their usual (routine) and fast walking speeds by getting them to walk in a flat hallway. in individuals with chronic lung disease, we anticipate that their usual walk speed will be helpful in exercise prescription and use in multidimensional scoring systems. however, it is important to first determine the measurement properties of these two walk speeds.


Eligibility criteria:
inclusion criteria: * clinical and spirometric diagnosis of copd * able to provide written informed consent exclusion criteria: * unstable cardiovascular disease * acute respiratory exacerbation within 4 weeks * neurologic or orthopedic limitation to walking * inability to comprehend instructions in english

Keywords: exercise testing functional status pulmonary rehabilitation
safety and efficacy study of the simultaneous treatment of upper facial lines (horizontal forehead lines, glabellar frown lines and crows feet) in subjects with moderate to severe upper facial lines

Conditions: Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)

Summary: the purpose of this study is to investigate the safety and efficacy of nt 201 (active ingredient: botulinum (neuro)toxin type a, free from complexing proteins) in the combined treatment of wrinkles in the upper face (upper facial lines \[ufl\]): horizontal forehead lines \[hfl\], glabellar frown lines \[gfl\], and lateral canthal lines \[lcl\]). it is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (mp) followed by an open-label extension (olex) period.


Eligibility criteria:
inclusion criteria: * outpatients (male or female) 18 years of age or older. * horizontal forehead lines (hfl), glabellar frown lines (gfl), and symmetrical lateral canthal lines (lcl) of moderate to severe intensity at maximum contraction as assessed by the investigator and subject according to merz aesthetics scales (mas). exclusion criteria: * previous treatment with botulinum neurotoxin (bont) of any serotype in the face within the last 12 months before injection. * any facial cosmetic procedure within the last 12 months before baseline injection. * previous treatment with any biodegradable filler in the face within the last 12 months before injection. * any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study). * any medical condition that may put the subject at increased risk with exposure to nt201.
effect of abdominal massage on gastrointestinal outcomes among critically ill patients

Conditions: Abdominal Massage

Summary: this study aims to investigate the effect of abdominal massage on gastrointestinal outcomes among critically ill patients receiving enteral feeding.

enteral feeding has a vital role in the care of critically ill patients. it is considered a routine patients care in intensive care units. enteral feeding is also a medical treatment as well as a part of nursing care. it is the preferred route of nutritional support in patients who are incapable of volitional intake. additionally, it helps to stimulate peristaltic movements of the digestive system, improves blood supply, strengthens the immune system, improves recovery, and reduces physiological stress. there are many complications associated with enteral feeding that can lead to an interruption of the feeding process, including gastrointestinal disorders, mechanical problems, fluid-electrolyte imbalance, and metabolic complications. feeding intolerance is the most main digestive complication including nausea, vomiting, diarrhea, excess gastric residual volume, abdominal distention, and constipation. aspiration is also a significant side effect of delayed gastric emptying and increased grv among cips. the society of critical care medicine and the american society for parenteral and enteral nutrition has recognized aspiration as one of the mutual complications of enteral feeding that should be evaluated before and during the feeding process. consequently, prolonged icu stays, and increased duration of mechanical ventilation, and mortality rate are side effects of feeding intolerance and aspiration. additionally, abdominal massage is one of the complementary and alternative medicine which is significantly grown in recent years. furthermore, it is an inexpensive, non-invasive intervention, and free from harmful side effects. besides, it can increase the number of intestinal movements and lead to easier food movement along the gastrointestinal tract. in addition, it allows contraction of the diaphragm more fully, increases the capacity of the lung, and strengthens breathing.

Eligibility criteria:
inclusion criteria: * all patients who are full outline of unresponsiveness (four) score is from 0-14 admitted to the previous icus who have nasogastric tube and within the first 24 hours from beginning enteral feeding will be included in the study. * age: adult cips ≥ 18 years. * gender: males and females. * negative gastric ph and glucose strip. exclusion criteria: * gastric intolerance (delayed gastric empty). * patients who suffered from spinal cord injury, could not be properly positioned for massage due to severe trauma. * patients receiving prokinetic medications (to avoid interfering with the massage effects). * patients who have contraindications to abdominal massage such as ascites, abdominal aortic aneurysm, ileus, diarrhea, recent abdominal surgery, bleeding of gi, abdominal tumor, and undergoing radiotherapy.
mindful after cancer: a mindfulness-based therapy intervention for sexual health after cancer

Conditions: Breast Cancer; Gynecologic Cancer

Summary: the objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (mindful after cancer, mac) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.

the specific aims are: 1) assess the feasibility of the mac program when delivered via videoconference and 2) assess preliminary effects of the the program.

Eligibility criteria:
inclusion criteria: * diagnosis of breast or gynecologic cancer at least one year prior to enrollment * english speaking * have access to a computer, smart phone, or tablet with internet access * ability to spend 15-30 minutes per day on program activities exclusion criteria: - stage 0 (carcinoma in situ)
study to evaluate gsk256066 in subjects with mild bronchial asthma

Conditions: Asthma; Mild Asthma

Summary: this study will evaluate the efficacy and safety of gsk256066 in the treatment of subjects with mild bronchial asthma, using a number of clinical and biological markers of efficacy.


Eligibility criteria:
inclusion criteria * documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation. * pre-bronchodilator fev1 \>75% of predicted at screening. * non-smoker * demonstration of a positive reaction to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair on skin prick testing at screening, or within 12 months of study start. * have asthmatic response * able and willing to give written informed consent to take part in the study. * available to complete all study measurements. exclusion criteria: * history of cardiovascular disease * clinically significant abnormalities in safety laboratory analysis at screening including any subject who has greater than "trace urine protein levels" following urinalysis at screening. * history of hayfever * the subject has tested positive for hepatitis c antibody or hepatitis b surface antigen. * the subject has tested positive for hiv antibodies. * the subject has positive drugs of abuse test. * subjects weighing less than 50kg are to be excluded from participating in the study. * the subject has participated in a study with a new molecular entity during the previous 3 months. * history of being unable to tolerate or complete methacholine, and/or allergen challenge tests. * there is a risk of non-compliance with study medication or study procedures. * history of blood donation (450 ml) within 2 months of starting the clinical study. * the subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. one unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.

Keywords: allergen methacholine gsk256066 mild asthmatics repeat dose challenge late asthmatic response
functional outcome after anastomotic leak after oesophagectomies

Conditions: Anastomotic Leak Esophagus; Swallowing Disorder

Summary: the main surgical treatment for oesophageal cancer is a curative resection, mostly performed according to ivor lewis. however, despite careful work and refined surgical techniques, anastomotic leakage (al) occurs in more than 1/10 of the patients. this severe complication normally requires immediate intervention, while over the last 10 years, endoscopic vacuum therapy (evt) has become the crucial therapy for broken-down anastomosis. the hypothesis is that despite suffering a severe complication, the subjective swallow function is not impaired in patients treated by evt after an anastomotic leak, compared to patients without al.

the investigators will select patients after oesophagectomy and perform a structured interview regarding their quality of life and subjective swallow function. results will be compared according to defined subgroups, especially patients with and without anastomotic leak.

Eligibility criteria:
inclusion criteria: * patients who received an ivor lewis oesophagectomy with reconstruction due to any reason * patients older than 18 years exclusion criteria: * patients with achalasia * inability to understand study procedure or to provide informed consent
transgender men, non-binary persons and testosterone treatment body identity clinic

Conditions: Transgenderism

Summary: the aim of this study is to investigate transgender men and non-binary persons before and during testosterone treatment. the study will focus on: * cardiovascular status * muscle strenght and power * aggression and quality of life * cardiac and respiratory function

introduction: the number of individuals with gender dysphoria seeking gender-affirming treatment is increasing. the short- and long-term effects of masculinizing treatment with testosterone are debated as serum testosterone increase up to 20-fold compared to cisgender women. we hypothesize that, testosterone treatment is associated with non-calcified coronary plaque (ncp) development in transgender men. methods and analyses: prospective, single-center, observational cohort study at the body identity clinic (bic), odense university hospital, denmark, where all investigations are performed at inclusion and after 1, 3, 5 and 10 years of testosterone therapy. ethics and dissemination: the regional committees on health research ethics for southern denmark (s-20190108) and the danish data protection agency approved the study (19/27572). signed informed consent will be obtained from all participants. all findings will be published in peer-reviewed journals or at scientific conferences.

Eligibility criteria:
inclusion criteria: transgender men exclusion criteria: none
long-term follow-up study

Conditions: Lymphoma, Non-Hodgkin; Relapsed Non-Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Non-Hodgkin Lymphoma; Lymphoma; B Cell Lymphoma; B-Cell Non-Hodgkin's Lymphoma; Hematologic Malignancy; Relapsed/Refractory Multiple Myeloma; Relapsed/Refractory Acute Myeloid Leukemia

Summary: this is an observational, non-interventional, ltfs of investigational caribou therapies in patients who have participated in a parent study: a prior caribou-sponsored clinical study, special access program, or an iit. the objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received ips in a caribou-sponsored clinical study, special access program or iit.

this is an observational, non-interventional, ltfs of investigational caribou therapies in patients who have participated in a parent study: a prior caribou-sponsored clinical study, special access program, or an iit. the objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received ips in a caribou-sponsored clinical study, special access program or iit.

Eligibility criteria:
inclusion criteria: * written informed consent (by patient or legal representative) obtained prior to study-specific activities/enrollment * completed a caribou-sponsored study or was administered caribou ip under a special access program or as part of an iit * use of an effective method of birth control by women of childbearing potential and their partners and men with partners of childbearing potential (partners must also use an effective birth control method) through 12 months post ip infusion. exclusion criteria: * none

Keywords: allogeneic car-t cb-010 cb-011 cb-012
the impact of liver cirrhosis on outcomes in trauma patients

Conditions: Cirrhosis

Summary: given that there are only a few studies on the effects of cirrhosis on trauma patients and none have addressed the impact cirrhosis has on the incidence of infections, it is important that we study this to determine the mortality in cirrhotic trauma patients and ascertain the incidence of infectious complications in these patients. we hypothesize that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.

there have been a select few studies addressing the effects of cirrhosis on trauma patients. these studies show an increase in morbidity and mortality. however, there is limitation in the depth and breadth of analysis. the primary aim of this study is to determine the mortality rates in cirrhotic trauma patients with a secondary end-point being the determination of the incidence of infections associated with these patients. given that there are only a few studies on the effects of cirrhosis on trauma patients and none have addressed the impact cirrhosis has on the incidence of infections, it is important that we study this to determine the mortality in cirrhotic trauma patients and ascertain the incidence of infectious complications in these patients. pi hypothesizes that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.

Eligibility criteria:
inclusion criteria: * cirrhotic trauma patients in the united states within 2010-2018 * patients ≥ 18 years old exclusion criteria: * patients less than 18 years old

Keywords: cirrhotic trauma
fertility preservation in case of endometriosis

Conditions: Endometriosis

Summary: fertility preservation is now considered as crucial for the well-being of women battling cancer. however, others indications have more recently emerged. women with endometriosis may represent a suitable group since they are at risk for compromise ovarian reserve. data on fp in endometriosis patients are rare: only small retrospective study, case-reports and opinion publications .nowadays, there is no available data concerning real indications for pf on endometriosis patients (endometriomas, risk of surgery, deep endometriosis?), criteria for eligibility (ovarian reserve parameters, age), quality of oocytes and number of oocytes necessary to give at least one live birth. we propose a monocentric observational cohort study, evaluating the efficacy of oocytes cryopreservation as fertility preservation procedure, in young adult female subjects with endometriosis, to finally define the criteria of eligibility for pf procedures in case of endometriosis.

monocentric observational cohort study, enrolling young patients with endometriosis, without birth project for the moment, and asking for fertility preservation, in order to preserve mature oocytes. protocol of this study : * information and signatures of consent file ; * ovarian stimulation, oocytes retrieval and mature oocytes cryopreservation (one or more procedures) * questionnaires every year, describing quality of life in this context of endometriosis and evolution (treatment, surgery, art, pregnancies) * data about number and rate of thawed oocytes after preservation, pregnancy rate and live birth rate with these oocytes.

Eligibility criteria:
inclusion criteria: * women from 18 to 36 years old * endometriosis disease proved by sonography, mri and/or surgery * consenting to participate to the study exclusion criteria: * any contraindication for ovarian stimulation. * any contraindication for pregnancy .- impossible follow-up.

Keywords: fertility preservation endometriosis endometriomas ovarian stimulation oocyte vitrification