Kornimate/medical-research-clean huggingface dataset:
my healthy brain: preserving and promoting brain health through evidence-based practices

Conditions: Aging; Mild Cognitive Impairment; Dementia; Old Age; Dementia; Cognitive Decline

Summary: the objective of this trial is to demonstrate early proof-of-concept for my healthy brain, an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of cognitive decline. the investigators will explore the feasibility, acceptability, and effect sizes of improvement in primary lifestyle outcomes as well as secondary outcomes of self-determination and subjective well-being.


Eligibility criteria:
inclusion criteria: * age ≥ 60 years * english fluency/literacy * ≥1 modifiable brain disease risk factor (outlined by jama) * bluetooth 4.0 enabled smartphone exclusion criteria: * diagnosis of dementia; montreal cognitive assessment \< 18 * serious medical illness expected to worsen in next 6 months * current suicidal ideation * substance abuse * untreated serious mental health conditions * current use of digital monitoring device (eg. fitbit) * mindfulness practice (\> 45 minutes/week) in the last three months

Keywords: health behavioral medicine clinical psychology
trauma-informed intervention to reduce substance use and to support community transition

Conditions: Substance Use Disorder (SUD)

Summary: the overall aim of this study is to reduce overdose risk for criminal legal system (cls) involved women during community re-entry through the adaptation and testing of an innovative, trauma-informed, relational intervention approach (trust-based relational intervention or tbri).

r61 phase (intervention adaptation): the tbri intervention will be strategically adapted for cls-involved women during the r61 to achieve 2 specific aims: 1) adapt tbri by focusing on adapting two intervention components - prison group sessions and re-entry recovery support - using focus groups with key stakeholders (n=30) including administrators, practitioners, and women with "lived experience," and target alignment with the unique treatment needs of the women and establish intervention approach feasibility; and 2) pilot test the adapted intervention components in one group of women (n=8) at the kciw facility. final adaptations will be made to the trust manual for the r33 implementation. r33 phase (intervention testing): the r33 will test the effectiveness of the adapted tbri-wra to reduce overdose risk in the community following prison release, while also collecting data on key constructs hypothesized to influence successful intervention implementation. the primary aim of the r33 is to examine effectiveness of the adapted tbri women's re-entry approach (tbri-wra) in reducing overdose risk among women (n=264) in four sites following release from prison-based sud treatment. study conditions include (1) treatment as usual (tau, standard in-prison sud treatment, n=88), (2) in-prison tbri (tau + tbri prison-based sessions only; n=88), and (3) tbri + re-entry recovery support (tau + prison-based tbri sessions + re-entry recovery support; n=88). the r33 will also examine implementation factors associated with study preparation, launch, sustainability, and scalability.

Eligibility criteria:
inclusion criteria: * participating in prison-based sud treatment program * have a release date within 3 months * self-identified history of violent victimization * have no indication of current suicidal risk, * able to identify one "safe support person" (ssp) in the community who can be trusted to support recovery and is willing to be contacted about participation exclusion criteria: * release date greater than 3 months * no self-identified history of violent victimization * indication of current suicidal risk * unable to identify one "safe support person" (ssp) in the community who can be trusted to support recovery and is willing to be contacted about participation

Keywords: overdose criminal legal system trust-based relational intervention (tbri)
thrice-weekly versus thrice-daily oral ferrous fumarate treatment in adult patients with iron deficiency anemia

Conditions: Iron Deficiency Anemia

Summary: iron deficiency anemia is a global health problem and the most common cause of anemia worldwide. patients with iron deficiency and iron deficiency anemia can present with a multitude of symptoms including fatigue, dyspnea on exertion, dysphagia, pallor, palpitations, headaches, tinnitus, taste disturbance and pica. oral iron supplementation is associated with increasing hemoglobin in multiple studies in women, pregnant women and elderly patients. however, the optimal dose and frequency of oral iron supplementation for treatment remains unclear. the current proposed study attempts to address this gap in the literature.


Eligibility criteria:
inclusion criteria: * age \>18 years * patients with iron deficiency anemia defined as hemoglobin less than 12 g/dl in women or 13 g/dl in men; and ferritin less than 30 ng/ml exclusion criteria: * allergy to iron * currently pregnancy * currently breastfeeding * known history of inflammatory bowel disease, celiac disease, inherited bleeding disorder, solid cancer, hematologic cancer or thalassemia * renal impairment or glomerular filtration rate less than 30 ml/min/1.73m2 * hepatic impairment or child pugh score more than 7 * active bleeding define hemoglobin decrease more than 2 g/dl * multivitamin and mineral supplement (35 mg or more of elemental iron per day) in 2 weeks prior to randomization * non-literate subject withdrawal criteria: * intolerance to drugs * active bleeding define hemoglobin decrease more than 2 g/dl * major surgery * blood transfusion * loss follow-up more than 2 weeks

Keywords: ferrous fumarate oral iron treatment thrice-weekly thrice-daily iron deficiency anemia
comparing outcomes of non-surgical versus surgical treatment of shoulder fractures with different shoulder replacements

Conditions: Proximal Humeral Fracture; Humeral Head Fracture

Summary: the optimal treatment of complex shoulder fracture is controversial. in general, non-surgical treatment is recommended for older patients, but results are often unsatisfying. therefore different surgical approaches have been tried to improve outcomes for this group of patients. reverse shoulder arthroplasty has shown promising results for these types of fractures and changes in the design of the implant might improve outcomes further. the aim of this study is to compare the outcomes of complex shoulder fractures after non-surgical versus surgical treatment and compare two different types of implants.

the optimal treatment of proximal humeral fracture (phf) neer type iii and iv ao b1.1,1.2 and c1.1,3.1 is controversial. national guidelines for denmark have been published in 2015 and updated 2019. they recommend conservative treatment to all kinds of phf for patients aged above 60 years. exceptions are fracture-dislocations, headsplits or surgical conditions, where intervention is mandatory like open fractures and impaired nerve- and circulation. recently reverse shoulder arthroplasty (rsa) has gained expanding popularity in treating phf . compared with osteosynthesis (orif) or hemiarthroplasty (ha) outcomes were superior , . the importance of tuberosity healing for good functional outcomes has lead to development of different implants and fixation techniques. the original rsa design by grammont with 155 degree inclination of the humeral stem was made for cuff-arthropathy. this design moves the center of rotation in a medial direction, and increase the tension on the tuberosities. in contrast "anatomical" designed humeral implants with 135 degree enables more anatomical refixation of the tuberosities with less tension and might reduce the risk of resorption or displacement of the fragments. to implant a 155 degree rsa the surgeon has to remove parts of the rotator cuff, to enable the sliding rotation. on the other hand with a 135 degree inclination humeral component, a cuff sparing technique is possible. the aim of this study is to compare outcomes of two different designed rsa stems versus conservative treatment of phf neer type iii or iv / ao b\&c.

Eligibility criteria:
inclusion criteria: displaced proximal humeral fractures (phf) neer type iii or iv / ao b\&c. radiological confirmed exclusion criteria: other types of phf, head splits, gleno-humeral dislocations, pathological fractures. refuse to participate in the study. non-compliant, drug/alcohol abuse or institutionalized, (low-cooperative),

Keywords: proximal humerus fracture reverse shoulder arthroplasty
diagnostic accuracy by providers study

Conditions: Vaginitis

Summary: the validation study is intended to provide comparative data on the diagnosis of vaginal infections as performed in primary care settings versus the diagnosis provided through standard diagnostic testing performed in a reference laboratory. the clinician and lab diagnoses will be compared to those obtained using the bd max vaginal panel on the bd max system.

the primary goals of this study are to: 1. compare the level of agreement of clinician diagnosed bacterial vaginosis (bv) to vaginal swab samples evaluated for bv using nugent's criteria and the bd max vaginal panel 2. compare the level of agreement of clinician diagnosed trichomonas vaginalis (tv) to the laboratory diagnosis of tv identified by quantitative pcr using the genexpert system by cepheid and the bd max vaginal panel. 3. compare the level of agreement of clinician diagnosed yeast vaginitis to laboratory diagnosis of yeast identified with culture and the bd max vaginal panel. the secondary goals of this study include: 1. being able to describe the patterns of testing among clinicians in community practices providing routine care for women presenting with symptoms of vaginitis. 2. describe the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory-confirmed diagnoses.

Eligibility criteria:
inclusion criteria: 1. female, age 18-40 2. presenting with symptoms of vaginitis; vaginal discharge, vaginal odor, vulvar or vaginal itch, vulvar or vaginal discomfort (i.e. irritation, burning pain or vulvar edema). 3. able and willing to provide verbal consent. 4. willingness to undergo all study-related assessments and procedures, including the collection of multiple vaginal swabs, answer questions related to demographic and health information and follow all other study-related procedures. exclusion: women who meet any of the following criteria by participant report will be excluded from the study: 1.) any condition that, in the opinion of the investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
peri-transfusion qol assessments (ptqa): a new paradigm of transfusion decision support for patients with mds

Conditions: Myelodysplastic Syndromes

Summary: this research study is evaluating how to best tailor blood transfusion decisions to match the quality of life changes experienced by individual patients with mds.

each patient with mds reacts differently to blood transfusions; some will feel better after transfusion, while others may not. the main purpose of this survey study is to determine whether it is possible to use quality of life changes - as measured by a validated questionnaire - experienced by individual patients to help physicians and patients with mds make decisions regarding future blood transfusions. this research is being done because the investigators hope to help doctors better understand the impact of blood transfusions on the quality of life of each patient. the study uses a standardized mds-specific quality of life questionnaire that participants will fill out before and after an upcoming transfusion. the investigators will compare the scores of these questionnaires and notify both the participant and provider if the participant has experienced any changes (positive or negative) in his/her quality of life before and after transfusion. the investigators' hope is that doctor-patient teams will use this quality of life information to determine whether the participant should continue receiving transfusions, decrease the frequency of transfusions, or stop receiving transfusions altogether if not needed.

Eligibility criteria:
inclusion criteria: * age \> 18 years of age * patients with mds * patients approaching an hb of 8.5 g/dl during enrollment period or * patients with \>1 transfusion scheduled during an 8-week period * ability to read and understand english exclusion criteria: * age \<18 years * cr \> 2 * known chf * unstable angina * hb level below 7.5 g/dl or above 8.5 g/dl * no plan for future transfusion. * patient enrollment will happen after patient has consented and scheduled their first/next transfusion. * patient will not be enrolled if no future transfusions are scheduled.

Keywords: mds myelodysplastic syndromes quality of life tranfusion-dependent
study to determine results of vibratory stimulus on subject's neck

Conditions: Sleep Apnea; Snoring

Summary: this study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

this study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement, and provide information regarding the optimum location and variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck, or jaw movement. the study will also provide information whether the subject experienced or did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's neck. the data gathered from this study will be used for future studies in analyzing whether such vibratory stimulus can serve as a potential treatment for sleep disorders, such as snoring and obstructive sleep apnea.

Eligibility criteria:
inclusion criteria: * male or female, ages 18 to 80 years old * able to provide written informed consent for themselves and comply with study procedures. exclusion criteria: * known hyposensitivity or hypersensitivity to vibrations on neck. * neurological disorder such as seizure disorder or narcolepsy. * psychiatric disorders currently not under control. * insomniacs. * pregnant women.

Keywords: apnea sleep apnea snoring hypoglossal nerve stimulation laynx stimulation
preoxygenation in the intensive care unit using a nose-mouth mask versus high-flow nasal cannula oxygen.

Conditions: Respiratory Failure

Summary: preoxygenation is routinely performed before endotracheal intubation. in the intensive care unit, preoxygenation is often accomplished using a nose-mouth mask. it seems probable that high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of hypoxemia during intubation. in this prospective randomized study preoxygenation using high flow nasal cannula oxygen is compared with preoxygenation via nose-mouth mask in patients with hypoxemic respiratory failure.


Eligibility criteria:
inclusion criteria: * patients treated in an intensive care unit * indication for intubation * presence of hypoxemic (sao2/fraction of inspired oxygen(fio2): 300 or less) respiratory failure * informed consent exclusion criteria: * blocked nasopharynx * contraindications for nose-mouth mask or high flow nasal cannula oxygen * expected difficult airway
innovative public-private partnership to target subsidized antimalarials in the retail sector (aim 2)

Conditions: Fever; Malaria

Summary: the overall objective of this study is to evaluate the public health impact of targeted antimalarials subsidies through scale-up by determining the community-wide effects of targeting an antimalarial subsidy through a partnership between community health volunteers (chvs) and the private retail sector. the primary hypothesis to be tested is that offering a fixed-price voucher that reduces the cost for artemisinin combination therapy (act) purchase in the retail sector conditional on a positive malaria test (targeted subsidy) can improve uptake of testing for malaria and will increase the proportion of fevers tested for malaria before treatment. the study will be carried out in two sub-counties in kenya with similar malaria burden but different access to health services; the investigators will use a cluster-randomized design to assign community units (cus) in each sub-county to either an intervention or control arm. chvs will be trained to use malaria rapid diagnostic tests (rdts) to diagnose malaria in household members with documented or reported fever; households in intervention cus will be informed of the intervention and encouraged to contact the chv for any febrile illness in the home. there are minimal risks associated with receiving an rdt. households with a positive rdt will be given a serialized voucher that will entitle the holder to purchase a quality assured act in the retail sector at a reduced, fixed price. the primary and secondary outcome measures will be compared at baseline and 12 months post-baseline through population-based surveying. the primary aim is to determine whether there is significant difference between the 2 study arms in the proportion of clients with fever who are tested prior to any treatment after adjusting for relevant covariates.


Eligibility criteria:
inclusion criteria intervention participation criteria: * client is older than 1 year * client has fever or history of fever or feeling unwell with a malaria-like illness within the last 2 days * client or their parent/legal guardian (if under 18) consents to participate cross sectional survey participation criteria: * household representative in the intervention or control arm * at least one member in the respondent's household with a history of fever or feeling unwell with a malaria like illness within the last four weeks * respondent is older than 18 years exclusion criteria intervention exclusion criteria: * client has signs of severe disease or other problem requiring immediate referral to a health facility * client has already visited a health facility, taken or purchased antimalarials for the current illness. cross sectional survey exclusion criteria: • households not in the intervention or control arms

Keywords: malaria antimalarial subsidy malaria rapid diagnostic test (rdt) public-private partnership community health workers
the press fit condylar (p.f.c.) sigma metal-backed versus all-poly

Conditions: Knee Osteoarthritis

Summary: the primary objective of this investigation was to evaluate \& compare the performance of the p.f.c. sigma knee cruciate-retaining all-polyethylene and metal-backed tibia components using rsa. the secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the p.f.c. sigma knee cruciate-retaining all-polyethylene and metal-backed tibia components.

using rsa, is it possible to evaluate the performance of both the all polyethylene and metal backed tibia components to determine whether there are differences in migration, if present, across the tibial components. the original protocol intended to perform clinical assessment using the nottingham knee score and the knee society clinical rating system pre-and post-operatively, at six months, 1 year, and annually thereafter. per protocol amendment 01 (effective june 18, 1999) clinical data would also be collected via the sf-12 questionnaire. radiological evaluation would also use the knee society scoring system at the same time points. however, data collected included only the sf-12 and oxford knee scores, comparing change from baseline at 6, 12, and 24 months after surgery.

Eligibility criteria:
inclusion criteria: * subjects requiring a primary knee replacement. * subjects aged 65 years or more. * subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. * subjects with a primary diagnosis of osteoarthritis or rheumatoid arthritis. exclusion criteria: * subjects who have had a previous surgery of the operative knee except menisectomy and arthroscopy. * subjects who have had a renal transplant. * subjects with a metabolic bone disorder. * subjects who, in the opinion of the clinical investigator, have an existing condition, e.g. paget's disease etc. that would compromise their participation and follow-up in this clinical investigation. * subjects whose contralateral knee is already included in this study. * subjects who have a history of active joint sepsis. * subjects who have a recent history of high dose systemic corticosteroids. * subjects with psycho-social disorders or physical disabilities that would limit rehabilitation. * subjects requiring a bone graft.

Keywords: arthroplasty, replacement, knee, p.f.c. sigma all-polyethylene
ulcer prevention ii

Conditions: NSAID Associated Gastric Ulcers

Summary: nonsteroidal anti-inflammatory drugs (nsaids) are often associated with gastric ulcers. this study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.


Eligibility criteria:
inclusion criteria: 1. no active/current gastric or duodenal ulcer on baseline endoscopy. 2. a clinical diagnosis of a chronic condition that requires daily nsaid treatment for at least 6 months. 3. other inclusion criteria, as defined in the protocol. exclusion criteria: 1. history of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer. * 2. history of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. * 3. other criteria, as defined in the protocol.

Keywords: nsaid, nexium, esomeprazole, gastric ulcers