Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of pentaxim as 3 doses primary vaccination followed by a booster dose at 18 months

Conditions: Diphtheria; Tetanus; Haemophilus Influenzae Type b; Pertussis; Poliomyelitis

Summary: as per request by the heath authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's dtacp-ipv// prp\~t combined vaccine (pentaxim™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available dtacp, hib conjugate (act-hib™) and ipv (imovax polio™) monovalent vaccines in order to meet the requirements for registration of the product in people's republic of china.


Eligibility criteria:
inclusion criteria : * aged 2 months (60 to 74 days) inclusive on the day of inclusion * born at full term pregnancy (³36 weeks) with a birth weight ≥ 2.5 kg * informed consent form signed by the parent(s) or other legal representative * able to attend all scheduled visits and to comply with all trial procedures exclusion criteria : * participation in another clinical trial in the 4 weeks preceding the trial inclusion * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion * blood or blood-derived products received in the past * any vaccination performed or planned in the 4 weeks preceding the first trial visit (except bcg and hepatitis b, which can not be given within 8 days before the first study visit) * vaccination planned in the 4 weeks following any trial vaccination (except bcg and hepatitis b, which can not be given within 8 days before or after the study vaccine(s) administration) * history of diphtheria, tetanus, pertussis, poliomyelitis, haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically) * clinical or serological evidence of systemic illness including hepatitis b, hepatitis c and/or hiv infection * previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or haemophilus influenzae type b infection with the trial vaccine or another vaccine * thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of/current seizures * febrile illness (axillary temperature ≥ 37.1°c) or acute illness on the day of inclusion

Keywords: diphteria tetanus haemophilus influenzae type b poliomyelitis pertussis
counteracting learned non-use through augmented visuomotor feedback in virtual reality (rgs)

Conditions: Hemiparesis

Summary: the purpose of this study is to determine if reinforcement-induced movement therapy (rimt), a novel rehabilitation method that augments visuomotor feedback of movements of the patient in virtual reality, is effective in treating hemiparesis resp. learned non-use.


Eligibility criteria:
inclusion criteria: * mild-to-moderate upper-limbs hemiparesis (proximal medical research council scale \> 2) due to ischemic or hemorrhagic stroke * spasticity in the affected limb (modified ashworth scale \<3) * first-ever ischemic or hemorrhagic stroke (\>4 weeks post-stroke) * sufficient cognitive capacity for following the instruction of the intervention (mini-mental state evaluation \>24) exclusion criteria: * cognitive impairment that impede the correct execution or understanding of the intervention * severe impairments in vision or visual perception abilities (such as vision loss or spatial neglect), in spasticity, in communication abilities (such as aphasia or apraxia), severe pain as well as other neuromuscular or orthopedic changes that impede the correct execution of the intervention training * mental dysfunctioning during the acute or subacute phase after the stroke.

Keywords: stroke learned non-use virtual reality hemiparesis
characterization of cleft lip and palate conditions in guatemala

Conditions: Cleft Lip; Cleft Palate; Cleft Lip and Palate

Summary: the purpose of this study is to compare types of and risk factors for cleft lip and palate in a guatemalan population to a united states population.

demographic, surgical, and cleft type data from us patients were gathered via chart review of the electronic medical record. data from guatemalan patients was gathered orally from patient caregivers in their native language. consent was also given orally in the caregivers native language. all data was de-identified prior to analysis.

Eligibility criteria:
inclusion criteria: * diagnosis of isolated cleft lip and/or palate * scheduled for cleft-related surgery at either the children's hospital of philadelphia or smiles for guatemala during the previously described time frames exclusion criteria: * diagnosis of a recognized medical syndrome * medically complex defined as having major medical problems in three or more organ systems * diagnosis of isolated midline cleft lip * diagnosis of tessier facial cleft * greater than 18 years of age
clinical utility of neurophysiological measurements of ecap-controlled closed-loop scs to guide treatment of chronic pain

Conditions: Chronic Pain

Summary: the purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ecap-controlled closed-loop scs (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.


Eligibility criteria:
inclusion criteria: * subject is planning to have a temporary trial with the evoke system to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain. * leg pain score ≥ 6 cm (visual analog scale \[vas\]). * back pain score ≥ 6 cm (vas). * subject is able to speak, read, and/or understand english, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits. * subject is not pregnant and not \<18 years of age. exclusion criteria: * n/a
pelvic floor dysfunctions and female athletes

Conditions: Pelvic Floor Disorders

Summary: pelvic floor dysfunctions (pfd) are especially prevalent among females athletes due to the efforts from sports practice. as conservational management, increasing the athletes' information regard important research lines. however, embarrassment of female athletes limits educational or health demands and facilitate an invisible condition, potentially influenced by gender stereotypes. new technologies could facilitate engaging virtual educational approaches. this study will evaluate the effects of an educational online session about pfd in the knowledge about it, and practices related with it, existing gender stereotypes and pfd diagnosis of female athletes. to this end, all female athletes who practice track and field in spain will be invited to attend an educational online session with theoretical-practical content about pf. as eligibility criteria, participants should train and compete in any of the track and field modalities, and have federative license from regional or national track and field federation at the moment of the start of the study. participants should have at least 18 years old. the investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational online session. before the educational online session, all female athletes will reply an anonymous questionnaire to inform about their knowledge of pfd, daily practices related to pfd, influencing gender stereotypes and pfd auto-reported diagnosis. one month later, this questionnaire will be sent to female athletes (both athletes who attended the educational session or not) to describe changes after attending the online educational session and compared to those athletes who did not attend it. the main outcomes will be the level of knowledge about pf, the number of detrimental practices potentially related to pfd, the number of healthy practices to care pf and existence of influencing gender stereotypes. as an additional outcome, it will be considered the pfd auto-reported diagnosis.

the educational online session will last 90 minutes, as follows: 10 minutes of contextualization, 40 minutes of practical content about pelvic floor consciousness and 40 of theoretical content (anatomy and practices related to pfd). also, a 3d realistic virtual model of pelvic floor structures will be used.

Eligibility criteria:
inclusion criteria: * to train and compete in any of the track and field modalities * to have federative license from regional or national track and field federation in the season when study starts. exclusion criteria: * non-applicable

Keywords: female athlete track and field education
implantation of gold beads to relieve discomfort from knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to determine whether implanting gold beads extraarticularly in five acupuncture-points around a knee improves pain, stiffness and function in patients with knee osteoarthritis.

osteoarthritis (oa) is one of the most common diagnoses made in general practice and among the most common causes of disability in older people. acupuncture is a well-founded supplement or alternative to pharmacological and surgical treatment methods. the improvement is, however, often brief, so to preserve the initial effect the acupuncture has to be repeated at regular intervals. in veterinarian medicine implantation of gold-beads in acupuncture-points around a joint has been used mostly in dogs for at least 30 years in the treatment of oa. the effect measured on eating pattern, physical activity and signs of pain last for several years. it may be hypothesized that implanting gold in acupuncture points acts as a continuous acupuncture stimulation. the purpose of this one year randomised, controlled trial of middle-aged and elderly patients is to examine the effect of implanting gold beads extraarticularly in five acupuncture-points around a knee with oa.

Eligibility criteria:
inclusion criteria: * age 18-80 years * clinically diagnosed and radiologically verified knee osteoarthritis (oa) * pain and stiffness derived from oa lasting for more than one year exclusion criteria: * previous knee trauma (oa following previous meniscectomy is included) * other rheumatologic conditions like rheumatoid arthritis or fibromyalgia * pronounced hip oa * severe somatic or mental illnesses * dementia * alcohol or drug abuse * pregnancy * anticoagulant treatment * corticosteroid treatment during the last 3 months * allergy to chlorhexidine or local anaesthetics

Keywords: acupuncture gold implantation osteoarthritis knee osteoarthritis double-blind, randomized controlled trial intervention family practice
a phase iii trial comparing uft+psk to uft+lv in stage iib, iii colorectal cancer

Conditions: Colorectal Cancer

Summary: to compare the efficacy of tegafur/uracil (uft) plus folinate calcium (leucovorin: lv) administered orally and uft plus krestin (psk) administered orally enrolling patients with ptnm stage iib or iii colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

to compare the efficacy of tegafur/uracil (uft) plus folinate calcium (leucovorin: lv) administered orally and uft plus krestin (psk) administered orally enrolling patients with ptnm stage iib or iii (uicc sixth version) colorectal cancer/histological curability a (japanese classification of colorectal carcinoma, sixth version) as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

Eligibility criteria:
inclusion criteria: * patients with ptnm stage iib or iii (uicc sixth version) primary colon cancer/rectal cancer who have undergone surgery of histological curability a (including laparoscopic surgery) (the curability is judged after surgery) * patients with primary tumor that directly invades other organs or structures and/or perforates into the visceral peritoneum (t4) or with histologically positive lymph node metastasis (n+) (to be judged after surgery) * patients who is between 20 and 80 years old at the time of obtaining informed consent * patients with performance status of 0 - 2 * patients without receiving any cancer treatment such as radiation, chemotherapy, and immunotherapy before surgical operation * patients without severe dysfunction of renal, hepatic, or bone marrow function * patients without serious complications such as bone marrow suppression, diarrhea, and infections diseases * patients who have given consent to participate in this clinical study by himself/herself or his/her family exclusion criteria: * patients in whom the bottom of tumor reaches the peritoneal reflection * patients with lower rectal cancer (rb), anal canal (p), or circumanal skin (e) * patients who has active multiple cancers or whose disease-free survival is less than 5 years even though the cancers are metachronous (except carcinoma in situ and skin cancers) * women who are currently pregnant or wish to be pregnant during this clinical study * patients who are judged to be inappropriate to participate in this clinical study by the investigator or subinvestigator
naloxone, hypoglycemia and exercise

Conditions: Diabetes Mellitus, Type 1

Summary: the overall objective of this project is to determine if the intranasal administration of naloxone during exercise will be a novel approach to preserve the counterregulatory response to hypoglycemia experienced the next day in patients with type 1 diabetes. exercise induced autonomic failure contributes to the development of impaired awareness of hypoglycemia. treatments that blunt the consequences of exercise induced autonomic failure, such as preserving the post-exercise counterregulatory response to hypoglycemia, may improve awareness of hypoglycemia. naloxone, an opioid antagonist, is an extremely promising agent. in healthy volunteers, intravenous administration of naloxone during exercise preserved the counterregulatory response to hypoglycemia the following day (1). in this study, investigators will extend the clinical applicability by administering intranasal naloxone to individuals with type 1 diabetes. specifically, the investigators will use a randomized, placebo controlled, crossover design to administer drug or placebo to patients with type 1 diabetes during acute exercise and assess the counterregulatory response to hypoglycemia the following day. the use of intranasal naloxone is a highly innovative aspect of this proposal. intranasal naloxone translates readily to clinical use and, as demonstrated by the investigators preliminary data, achieves similar plasma drug concentrations as after iv administration.


Eligibility criteria:
inclusion criteria: * type 1 diabetes diagnosed on clinical grounds (history of dka, use of insulin within 6 months of diagnosis) * diabetes duration \ 2 years (to ensure that they have lost hypoglycemia induced glucagon secretion as is typical in patients who develop impaired awareness of hypoglycemia) * age 18 - 65 years * baseline hemoglobin a1c 6.8 - 9.0% (range selected to reduce the risk of hypoglycemia and uncontrolled diabetes in the weeks before the study, both of which may affect the responses to hypoglycemia) * awareness of hypoglycemia as verified by cox questionnaire exclusion criteria: * history of stroke, seizures (other than those related to hypoglycemia), arrhythmias, active cardiac disease * history of hypertension or blood pressure \> 140/95 mm hg at screening visit * pregnancy or plan to become pregnant during the study period * health related limitations in exercise (including but not limited to: angina, uncontrolled asthma, peripheral arterial disease) * unwillingness to avoid exercise during the 7 days before each part of the study * concomitant medical problems that may prevent the participant from successfully completing the protocol * smoking as defined by 2 or more tobacco cigarettes a week * daily use of opioids or an opioid antagonist or use in the past two weeks * unwillingness to wear a continuous glucose monitor for one week before and one week after each part of the study
benefits of mpact in locally advanced head and neck cancer patients undergoing chemoradiotherapy

Conditions: Head and Neck Neoplasms

Summary: the goal of this study is to test, in a randomized controlled trial among head and neck cancer patients, the short and longer term effects of the mpact (maintaining physical activity during cancer treatment) program (infused with motivational interviewing and self-determination theory-based strategies) initiated at the time of concurrent chemotherapy with radiation (ccrt), on key outcomes such as functional mobility and quality of life, and ultimately physical activity. the central hypotheses is that in head and neck cancer patients undergoing ccrt, the mpact program, as compared to usual care controls, will result in less acute decline, faster recovery, and better maintenance of these key outcomes.


Eligibility criteria:
inclusion criteria: * patients greater than or equal to 40 years old with ajcc (american joint committee on cancer) stage ii-iv head and neck squamous cell carcinoma who are beginning first-line non-surgical treatment with concurrent chemoradiotherapy (ccrt) and who are capable of understanding and adhering to the protocol requirements * patients must be willing to comply with the study procedures and visits. exclusion criteria: * active or symptomatic cardiopulmonary disease * substantial dementia * acute medical conditions, such as acute flare-up of joint condition or infection * participants must not be actively receiving physical therapy in a relevant area, at the time of enrollment, or participating in intensive (30 min per day) aerobic program three times per week. * patients are actively being treated for another cancer at the time of enrollment * active or unstable metabolic conditions such as brittle diabetes or severe anemia * alcohol intake less than 3 ounces per day * hemiplegia or lower limb amputation * significant orthopedic or musculoskeletal condition that does not allow weight bearing * unable to maintain safe stance and walk, either with or without an assistive device
establishing malnutrition diagnosis system by using artificial-intelligence technology

Conditions: Disease-related Malnutrition

Summary: the prevalence of malnutrition is estimated at 30-50% of hospitalized patients in china. disease-related malnutrition increases the risk of infection, mortality, length of hospitalization as well as the economic burden. national nutrition plan proposed to reduce malnutrition, but a clear, effective roadmap and protocol has not existed yet. several factors impede to resolve the above challenges. they include :1) the low efficiency of current malnutrition diagnosis methods; 2) the lack of dynamic, standard method that can evaluate nutritional status in quantitative way. to this end, the investigators aim to establish an artificial-intelligence malnutrition diagnosis system to improve the application of malnutrition clinical pathway. firstly, the investigators will establish a multidimensional malnutrition large data set, based on our previously built national hospital nutrition screening data set. it will contain deep 3d facial images, semi-structured and structured electronic medical record. then, the investigators will use ensemble learning algorithm to establish a fully automatic, artificial-intelligence malnutrition diagnosis model that includes both etiological and phenotypic diagnosis.


Eligibility criteria:
inclusion criteria: * adults (≥18 years old); * within 48 hours of admission; * inpatients at high risk of malnutrition, such as malignant tumors, chronic obstructive pulmonary disease, etc; * han nationality; * able to given informed consent. exclusion criteria: * patients with artificial facial changes (such as plastic surgery , head and neck radiotherapy , head and neck trauma); * diseases with special facial changes (such as acromegaly); * high dose glucocorticoid users; * patients with facial edema; * emergency admission with an expected length of stay of less than 3 days; * other conditions researchers thought could not be included
prevention of delirium with light in the intensive care unit

Conditions: Delirium

Summary: the purpose of this multicenter randomised controlled trial is to investigate if circadian light at the patients bedside (using philips healwell system, ce marked)significantly reduces prevalence of delirium in mechanically ventilated intensive care unit patients.

patients, who are randomly assigned to the "lightening arm" will have the circadian light for the whole icu stay. light levels at the patients bedside will be measured continuously: embedded light sensors provide irradiance and luminous lux recordings in red, green, and blue color bands and a white light measurement in lux

Eligibility criteria:
inclusion criteria: * male and female patients with age 18 years and above * intensive care unit stay ≥ 48 hours * invasive mechanical ventilation or not invasive mechanical ventilation (with positive ventilation pressure \>6hours/day and highflow \>30 litres) on the day of intensive care unit admission exclusion criteria: * patients with a history intensive care unit stay during the actual hospital stay * patients with delirium on the day of intensive care unit admission * patients with psychiatric diseases * patients with a history of stroke and known cognitive dysfunctions * participation in other clinical studies 10 days before study inclusion and during the study period * psychiatric disease * history of stroke with known residual cognitive deficits * history of asystolia or pulseless electric activity with cardiopulmonary resuscitation during entire hospital stay * analphabetism * unability of german language use * anacusis or hypoacusis with hearing aid device, amaurosis * allergies to any ingredient of the electrode fixing material * lacking willingness to save and hand out data within the study * accommodation in an institution due to an official or judicial order * the informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time * patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial

Keywords: delirium, light, icu, sleep