Kornimate/medical-research-clean huggingface dataset:
multidisciplinary treatment of obesity prior to in vitro fertilization: impact on global reproductive outcomes (pro-fiv study)

Conditions: Obesity; Infertility

Summary: the aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to ivf on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors. this is a randomized controlled trial in obese infertile women before starting an ivf cycle. the intervention is based on a structured multidisciplinary program in support groups, which includes diet, physical activity and psychological therapy. ivf will be started immediately after this therapy. patients included in the control group will start an ivf cycle immediately after the randomization. the results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.

the aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to ivf on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors. this is a randomized controlled trial in obese infertile women (body mass index ≥30 kg/m2) before starting an ivf cycle. in the intervention group, the aim is a weight loss of at least 10% in a 16-week period of treatment based on a multidisciplinary approach and support groups, which includes diet, physical activity and psychological therapy. ivf will be started immediately after this period. patients included in the control group will start an ivf cycle immediately after the randomization. the results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.

Eligibility criteria:
inclusion criteria: * obese infertile patients (body mass index ≥ 30 kg/m2) prior to an in vitro fertilization cycle exclusion criteria: * pathological conditions: diabetes type i, cushing syndrome, premature ovarian failure, uncontrolled thyroidal dysfunction, hepatic and/or renal dysfunction, antiphospholipid syndrome, medical condition that contraindicate ovarian stimulation and/or pregnancy * simultaneous practice of another strategy to lose weight * physical conditions limiting exercise training * patients unable to understand spanish language or to give informed consent

Keywords: obesity infertility in vitro fertilization
covid-19 convalescent plasma treatment in sars-cov-2 infected patients

Conditions: Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia; Pneumonia, Viral

Summary: due to the limitations of covid-19 treatment and in the absence of licensed antiviral for covid-19, the historical choice of therapeutic convalescent plasma (cp) is considered especially against rna viruses .it was known that convalescent plasma does not only neutralize the pathogens but provide passive immunomodulatory properties that allows the recipient to control the exaggerated inflammatory cascade. however, still there is a lack of understanding of the mechanism of action of ccp therapeutic components. reports from open label trials and case series show that ccp is safe and might be effective in severe cases with covid-19 . therefore, the world health organisation (who) and food and drug administration (fda) issued guidelines for the ccp usage and standardised the donor selection , which was further supported by emergency use authorisation (eua) . therefore, the aim in the current study is to assess the effect of ccp on time to clinical improvement, hospital mortality and to evaluate the changes on oxygen saturation and laboratory markers (lymphocyte counts and c-reactive protein) compared with standard treatment alone in patients with moderate or severe covid-19 disease.

this is a prospective multicenter interventional observational study will be conducted in 4 major tertiary hospitals (al-sabah, farwaniya , mubarak al-kabeer and jahra) in kuwait .

Eligibility criteria:
inclusion criteria: 1. patients aged ≥18 years old ( those who are younger are involved after case based discussion) 2. confirmed laboratory diagnosis with sars-cov-2 ,and admission diagnosis of sars-cov-2. 3. patients with moderate or severe covid-19 (moderate covid-19 disease defined as the presence of any signs of pneumonia (fever, cough, dyspnoea fast breathing) including spo2 \>90 on room air , but no signs of severe pneumonia (severe pneumonia have the above plus one of the following: respiratory rates \>30 breaths/minutes or spo2\<90% on room air), or admission to intensive care unit (icu) for respiratory support (i.e.high flow nasal cannula, non-invasive mechanical ventilation and intubation). exclusion criteria: 1. -contraindication to transfusion (volume overload, history of anaphylaxis to blood products). 2. - patients presenting with acute severe multiorgan failure, hemodynamic instability. 3- severe disseminated coagulopathy (dic), septic shock and those with expected survival of less than 48 hours.

Keywords: convalescent plasma respiratory infection covid-19 sars-cov-2 pneumonia
a phase 1b/2a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of medi8897, a monoclonal antibody with an extended half-life against respiratory syncytial virus, in healthy preterm infants

Conditions: Respiratory Syncytial Virus

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (rsv) monoclonal antibody compared to placebo when administered to healthy preterm infants.

this phase 1b/2a study will be a dose-escalation design to begin data collection on pk and safety in children. the population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive rsv prophylaxis based on the american academy of pediatrics (aap) or other local guidelines. these subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of rsv medically attended lower respiratory illness (ma-lri) and efficacy. enrollment is planned at approximately 20 sites in the usa, chile, and south africa.

Eligibility criteria:
key inclusion criteria: * healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age * infants who are entering their first rsv season at the time of screening key exclusion criteria: * gestational age \ 34 weeks 6 days * meets aap or other local criteria to receive commercial palivizumab * any fever (≥ 100.4°f \[≥ 38.0°c\], regardless of route) or lower respiratory illness within 7 days prior to randomization * acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization * active rsv infection (a child with signs/symptoms of respiratory infection must have negative rsv testing) or known prior history of rsv infection * receipt of palivizumab or any rsv vaccine, including maternal rsv vaccination

Keywords: respiratory syncytial virus, rsv
combining pembrolizumab and metformin in metastatic head and neck cancer patients

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to determine anti-tumor activity by measuring overall response rate in recurrent and/or metastatic hnscc patients receiving the combination of metformin and pembrolizumab.

recurrent and/or metastatic hnscc patients will be treated with combination of metformin and pembrolizumab. patients will be randomized into arms 1 and 2, to either receive metformin prior to pembrolizumab or to begin metformin after pembrolizumab treatment begins. the patients are randomized for the exploratory endpoints in order to better understand the difference of effects of metformin versus pembrolizumab on the immune system although efficacy is based on combination.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed recurrent or metastatic non-cutaneous hnscc for which there are no surgical or radiation curative options. * patients may have received up to 3 prior lines of therapy for metastatic or recurrent disease. * ecog performance status ≤2 exclusion criteria: * patients with nasopharyngeal hnscc will be excluded * patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study. * patients who have not recovered from adverse events due to prior anti-cancer therapy * patients who have previously received pd-1 or pd-l1 inhibitors for metastatic/recurrent disease * patients currently receiving metformin or who have received metformin in the last 6 months
metabolic sodium mri to assess early response of breast cancer to neoadjuvant chemotherapy

Conditions: Breast Cancer; Triple Negative Breast Cancer

Summary: neoadjuvant chemotherapy (nact) is administered to treat invasive breast cancer before surgery. it offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. investigators propose to develop a sodium breast mri technique that will allow to assess the early metabolic response of breast cancer to nact, occurring before late structural changes can be detected with standard mri. this study will scan 12 patients using 1h/23na mri at 7 t and dce mri with triple-negative breast cancer undergoing ac-t therapy (2 months of adriamycin + cyclophosphamide, then 3 months of taxol): at baseline (pre-nact); after the first ac cycle (2 weeks); after ac treatment (2 months); after complete nact (5 months, pre-surgery).


Eligibility criteria:
inclusion criteria: * women with no sign of breast cancer as controls * non-pregnant and non-lactating * ability to understand and willingness to sign a written consent exclusion criteria: * contra-indications to mri (i.e., ferromagnetic prostheses, metallic surgical implants that are not compatible with an mri machine, claustrophobia etc.) * medical condition such as uncontrolled infection (including hiv), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. * pregnant or lactating women, women using hormonal treatment in the 6 months prior to the study. * women with history of breast disease, previous breast surgery, or breast implants. * patients with a currently active second malignancy other than non-melanoma skin cancers. patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for 3 years. * psychiatric illness or other conditions and circumstances which could prevent the patient from being compliant with the protocol.
peep during induction of anesthesia in small children

Conditions: Pediatric Anesthesia

Summary: positive end-expiratory pressure (peep) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. peep also prevents atelectasis formation in pediatric patients. because pediatric patients arterial desaturation during induction of anesthesia develops rapidly, we studied the clinical benefit of peep applied during anesthesia induction.


Eligibility criteria:
inclusion criteria: * pediatric patients undergoing general anesthesia using endotracheal intubation exclusion criteria: * previous history of lung disease * anticipated difficulty in airway management
somatropin effect on linear growth and final height in subjects with noonan syndrome

Conditions: Genetic Disorder; Noonan Syndrome

Summary: this trial is conducted in europe. the aim of this trial is to evaluate the effect of somatropin (norditropin®) on final height in children with noonan syndrome having being treated for up to 10 years with somatropin (norditropin®) for the attainment of an optimal final height in the original trial s/ghd/004/noo.


Eligibility criteria:
inclusion criteria: * participation in the original s/ghd/004/noo trial or following the protocol for s/ghd/004/noo without being randomised in the trial
the combination of aripiprazole and antidepressants in psychotic major depression

Conditions: Psychotic Depression

Summary: the purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (abilify) and selective serotonin reuptake inhibitors (ssris) in subjects with psychotic major depression.


Eligibility criteria:
inclusion criteria: 1. men and women aged 18-80 years, inclusive. 2. drug-free outpatients or inpatients meeting dsm-iv criteria for major depression with psychotic features. 3. inpatients who undergo a 5-7 day washout period of their medication while concurrently beginning one of the approved ssri's and abilify. 4. ham-d-24 score \> 16. exclusion criteria: 1. pregnant women and women of child bearing potential not using a medically accepted means of contraception (oral contraceptives are allowed). 2. women who are breast-feeding. 3. patients meeting dsm-iv criteria for major depression without psychotic features, or psychosis without major depression at the screen visit. 4. patients with serious suicidal risk. 5. patients with a history of seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function. 6. patients meeting criteria for the following dsm-iv diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; bipolar disorder; schizoaffective disorder; or antisocial personality disorder. 7. patients who are currently taking an antidepressant, antipsychotic, or mood stabilizing drug and who are responding to one or all of these medications. if patients are not responding to these medications, they may go through a washout period of at least one week under the supervision of a study doctor before entering into this study. 8. patients who are not able to read and understand the consent form, or who are not capable of understanding or giving informed consent to the procedures of the study
effect of an educational program for staff in nursing homes concerning patients fecal incontinence

Conditions: Fecal Incontinence

Summary: fecal incontinence (fi) has an increasing prevalence in the geriatric population which cannot be explained by co-morbidity or anatomical and psychological changes of aging alone. in the nursing home population previous studies suggest a prevalence between 10 and 69%, but is most often reported to be between 40 and 55%. fi leads to a high direct and indirect economic burden to the health-care system, and is an important cause og institutionalization of the elderly patients. in addition, fi is associated with shame, social isolation and reduced quality of life. the importance of identifying treatable causes of fi in the frail elderly, rather than just managing passively, is strongly emphasized. it is indicated that the level of awareness among health personnel regarding appropriate assessment and treatment options is limited, and that fi is considered a normal part of aging. this study is based on the assumption that fi among nursing home patients can be prevented, cured or ameliorated by offering nursing home staff knowledge of best practise. the primary objective of the study is to test the hypothesis that a multifaceted educational program for staff on assessment and treatment of fi, is associated with a reduction in patients' frequency of fi. the design of the study is a two armed cluster randomized trail (c-rct) with a repeated cross-sectional approach.the results will be analysed according to multilevel and longitudinal modelling, and the study will use mixed effect models with the cluster treated as a random effect.


Eligibility criteria:
inclusion criteria: nursing homes with similar: * patients characteristcs * care staff/patients ratio * general practitioner consultancy patients: - all patients on long term care residency (residency \>month) registered nurses/authorized social educators: - all working half time or more exclusion criteria: nursing homes: - with some kind of speciality (eks rehabilitation, dementia) patients: - short term care residency registered nurses/authorized social educator: * working less than half time * working only night shifts

Keywords: education nurses nursing homes fecal incontinence cluster-randomized controlled trial
robotic evaluations of motor learning during stroke neurorehabilitation

Conditions: Stroke

Summary: the relearn trial is a a prospective longitudinal cohort study sampled by convenience. stroke survivors and healthy control individuals will be recruited to analyze motor learning in the upper extremity and its neural basis in early stroke recovery.

in stroke rehabilitation, clinicians guide the relearning of motor skills to promote recovery and improve function. a common assumption is that motor learning interacts with processes that are involved in tissue repair and helps to engage neuroplastic mechanisms that promote recovery. one of the biggest roadblocks for advancing the treatment of motor deficits is that we do not understand how motor learning changes after stroke, and critically, if poor recovery is due to a loss in an individual's ability to adapt or learn. existing clinical tests do not directly assess motor learning. this means that therapists can profile stroke impairments (motor, sensory, cognitive, etc.) but cannot directly measure a patient's ability to learn, which is likely an important factor in recovery. the relearn trial will pair robotics, an objective tool to assess post-stroke arm impairment, with neuroimaging to link motor learning deficits with possible influencing factors (sensory, motor, cognitive function) and damage in specific brain areas. participants with stroke will undergo clinical and robotic evaluations at baseline (within 1-13 days post-stroke), at 6 weeks, at 12 weeks, and again at 26 weeks. an mri assessment will occur during week 6. stroke participants will complete a 24hr retention assessment after baseline visit and week 26 visit. control participants will undergo a single robotic evaluation and a 24hr retention assessment.

Eligibility criteria:
inclusion criteria for stroke participants: * first time, unilateral ischemic stroke in middle cerebral artery territory, motor and/or sensory tracts and confirmed by clinical examination (including neuroimaging) * 7±6 days post-stroke * upper limb impairment * \>18 years old * fugl-meyer upper extremity score between 30 and 57 * vision better than 20/50 (corrected) * able to follow 3-step task commands inclusion criteria for control participants: * \>18 years old * good health exclusion criteria for stroke participants: * history of: 1. past undiagnosed stroke (evident on neuroimaging), 2. neglect (screened with behavioral inattention test), 3. apraxia, or 4. upper extremity orthopedic or muscular issues * secondary neurologic injury or disease (e.g., parkinson's) * contraindication to mri * medical or neuropsychiatric conditions that would interfere with study outcomes, or where participation presents a risk to the subject * enrollment in an interventional trial that supplements standard therapy exclusion criteria for control participants: • significant upper limb neurologic or orthopedic conditions

Keywords: rehabilitation neuroimaging motor learning early stroke recovery neuroplasticity limb dominance
closing the loop in adults with type 1 diabetes in the home setting

Conditions: Type 1 Diabetes Mellitus

Summary: the main study objective is to compare real-time continuous subcutaneous glucose monitoring (cgm) combined with overnight automated closed-loop glucose control, and real-time cgm alone in the home setting.

achievement of tight glycaemic control in type 1 diabetes mellitus (t1d) using intensive insulin regimens, which has been shown to be important for the prevention of long term diabetes-related complications, is limited by a significantly increased risk of hypoglycaemia. the average patient with t1d suffers two symptomatic episodes of hypoglycaemia per week, and one episode of severe hypoglycaemia, defined as an event requiring assistance of another person to administer rescue treatment in the form of carbohydrate and/or glucagon, per year.despite the rapid advancements in insulin pump technology and the ongoing development of more physiological insulin preparations, the currently available therapeutic regimens are still unable to achieve optimal glycaemic control.the emergence of continuous glucose monitoring (cgm) over the last decade, which enables users to view in real-time estimates of plasma glucose and receive alarms for impending hypo- or hyperglycaemia, thus facilitating appropriate changes in insulin therapy, is a major step towards improved diabetes monitoring. the desirable goal is the development of an insulin delivery that is glucose responsive and the development of effective real time glucose monitoring should allow this. glucose responsive insulin delivery should allow achievement of ideal glucose targets with less risk of hypoglycaemia. closed-loop systems may provide a realistic treatment option for people with t1d. the research we are conducting at the university of cambridge has been focused on developing a closed-loop system for overnight glucose control in patients with t1d. the studies that have been performed so far employ model predictive control (mpc) - this algorithm estimates patient-specific parameters from cgm measurements taken every 1 to 15 minutes and makes predictions of glucose excursions, which are then used to calculate basal insulin infusion rates. we hypothesize that overnight automated closed-loop glucose control in the home setting will be efficacious and safe compared to cgm alone, in t1d subjects on insulin pump treatment.

Eligibility criteria:
inclusion criteria: * type 1 diabetes, as defined by who for at least 6 months or confirmed c-peptide negative. * on insulin pump therapy for at least 3 months exclusion criteria: * non-type 1 diabetes mellitus * any physical/psychological disease likely to interfere with the study * taking medication likely to interfere with interpretation of the results * known/suspected allergy against insulin * patients with clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator * ongoing severe recurrent hypoglycaemia as judged by the investigator.