Kornimate/medical-research-clean huggingface dataset:
examining the ability of herpes simplex virus type 2 (hsv2) therapy to reduce hiv target cell numbers in the cervix

Conditions: Herpes Simplex Type Two Infection; HIV Infections

Summary: herpes simplex virus type 2 (hsv2), the most common cause of genital herpes, increases a woman's risk of hiv acquisition from 3-6 fold, perhaps because hsv2-infected women have increased numbers of hiv "target cells" (cd4 t cells and dendritic cells) in the cervical mucosa. however, recent clinical trials showed no impact of hsv2 suppression on hiv acquisition rates. the reasons for this negative result are unclear. the investigators propose to examine the effect of valacyclovir (a widely used herpes medication) treatment on cervical immunology and hiv target cells in the cervix. the study will take the form of a randomized, double-blind, placebo-controlled crossover trial. primary endpoints will be (1) the number of cd4 t cells on a cervical cytobrush and (2) the number of immature dendritic cells per cervical cytobrush.


Eligibility criteria:
inclusion criteria: * female * hsv2 infected exclusion criteria: * hiv infected * pregnant * taking hsv2 therapy * current/recent (past 3 months) genital infection

Keywords: herpes simplex virus type 2 hiv genital immunology cd4+ t cell valacyclovir hiv seronegativity
preoperative exercise in patients undergoing total hip or knee replacement

Conditions: Osteoarthritis

Summary: this study is conducted in the community hospital in svendborg (ouh svendborg sygehus) in collaboration with university of southern denmark and odense university hospital. the overall purpose of this study is to evaluate the effects of preoperatively delivered neuromuscular exercise on self perceived physical function, pain and quality of life in patients undergoing total hip or knee replacement. secondary area of interest is physical performance, muscle function, and level of physical activity. the project will be conducted in two phases: * a pilot project focusing on the logistics of the upcoming randomized controlled trial (rct) and determination of test-retest reliability of specific muscle strength variables for the patients of interest * a randomized and controlled trial where the intervention is preoperative neuromuscular exercise and the controls receive standard instructions.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective primary, unilateral total hip or knee replacement in svendborg community hospital, odense university hospital, denmark. * patients with osteoarthritis * age over 18 exclusion criteria: * not being able to read and understand danish. * patients with co-morbidity diseases where a moderate level of physical exercise is contraindicated, e.g. severe heart disease and neurological deficits. * patients unable to attend intervention. * rheumatoid arthritis (ra). a history of or ongoing use of medication for ra or other inflammatory arthritis such as gold, methotrexate, plaquenil etc. * lack of wish to participate or unwillingness to sign an informed consent. * specific for hip patients: a history of severe sequelae due to congenital hip-dysplasia requiring specialized postoperative training. a history of femoral neck and trochanteric fracture. * patients planned to have bilateral joint replacement within same procedure.

Keywords: preoperative exercise joint replacement hip knee
action observation and motor imagery therapy in parkinson's disease

Conditions: Parkinson's Disease

Summary: in recent years, motor imagery (mi) and action observation (ao) therapy strategies have been used in rehabilitation programs to increase motor learning in parkinson's disease (pd). visuomotor training strategies such as ao and mi therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind. the aim of this clinical trial is to test whether the application of ao and mi treatment in pd in addition to conventional rehabilitation programs has an additional effect on balance, functional status and quality of life.

parkinson's disease (pd) is a neurodegenerative disease with a chronic and progressive course. freezing phenomena, gait disorders, and balance problems are common in pd. gait and balance disorders and motor freezing attacks that occur as a result of pd increase the risk of falling, leading to a decrease in functional independence and quality of life. the main goal of parkinson's rehabilitation is to ensure the maximum functional status and independence in daily living activities and to increase their quality of life. in recent years, motor imagery (mi) and action observation (ao) therapy strategies have been used in rehabilitation programs to increase motor learning in pd. visuomotor training strategies such as ao and mi therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind. the aim of this clinical trial is to test whether the application of ao and mi treatment in pd in addition to conventional rehabilitation programs has an additional effect on balance, functional status and quality of life.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of parkinson's disease * hoehn and yahr stage 1-3 exclusion criteria: * patients with cognitive dysfunction (those who cannot follow simple verbal instructions) * patients with severe hearing problems * patients with severe vision problems * patients with additional musculoskeletal system pathology that will affect physical performance (such as amputation, severe joint mobility limitation, peripheral nerve damage) * patients with uncontrolled hypertension and diabetes mellitus * patients with a history of symptomatic lung disease (such as asthma, chronic obstructive pulmonary disease, emphysema) * patients with a history of symptomatic cardiac disease (such as coronary artery disease, arrhythmia, heart failure)
intravenous cardioversion of atrial fibrillation (af) with azd1305

Conditions: Atrial Fibrillation

Summary: this study is being carried out to see which dose of azd1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.


Eligibility criteria:
inclusion criteria: * clinical indication for cardioversion of atrial fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm * current episode of atrial fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation * adequate anticoagulation according to international guidelines (acc/aha/esc, 2006) or national guidelines exclusion criteria: * potassium level below 3.8 mmol/l measured in serum or plasma * qtcf interval \>440 ms

Keywords: azd1305 intravenous cardioversion of atrial fibrillation
the babygrow longitudinal study of nutrition and growth in preterm infants

Conditions: Premature Birth of Newborn; Malnutrition; Intrauterine or Fetal, Small-for-dates

Summary: this is a longitudinal, observational study on nutrition, growth and body composition in preterm infants. aims to determine the adequacy of actual nutrient intake during the preterm period by investigating associations between macronutrient supply, growth, and body composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.

infants between 23 and 24 weeks gestation and with a birth weight of 500 to 1500 g are recruited to a longitudinal, observational study of nutrition, growth and body composition in cork university maternity hospital, ireland.

Eligibility criteria:
inclusion criteria: * babies with a birth weight ≤1.5kg and gestational age ≤34 weeks were considered eligible. exclusion criteria: * presence of congenital abnormalities or conditions that interfere with growth or body composition (congenital diseases, chromosomal abnormalities, chronic lung disease, cardiac or gastrointestinal diseases).

Keywords: preterm birth parenteral and enteral nutrition body composition in preterm infants
an open trial of metacognitive therapy for anxiety and depression in cancer

Conditions: Anxiety; Depression; Cancer

Summary: survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the united kingdom, projected to increase to 4 million by 2030. around 25% of these survivors require treatment for clinical levels of emotional distress. the investigators will conduct a phase i open trial to test the potential efficacy of mct in cancer survivors.

survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the united kingdom, projected to increase to 4 million by 2030. around 25% of these survivors require treatment for clinical levels of emotional distress. there is scope for improvements in the efficacy of current pharmacological and psychological interventions. reflecting this limited efficacy in the face of the need for psychological treatment, the national cancer survivorship research initiative highlighted development and evaluation of practically feasible interventions for depression and anxiety in cancer survivors as an urgent research priority. it is recognised that current influential psychotherapeutic approaches need to be modified to meet the specific needs associated with cancer. however modifications have been pragmatic rather than theory-driven and have not improved efficacy. this study addresses the stages of 'development' and 'piloting and feasibility' in intervention development, albeit with a relatively well-defined starting point given existing evidence for efficacy of mct in other settings and promising preliminary evidence of applicability in cancer. the investigators will conduct a phase i open trial to test the potential efficacy of mct in cancer survivors.

Eligibility criteria:
inclusion criteria: * cancer diagnosis at least 6 months previously * scoring \>15 on the hospital anxiety and depression scale total * stable on, or free from, psychotropic medication exclusion criteria: * history of psychotic disorder, learning disability, or organic mental disorder * risk of self-harm or suicide warranting immediate intervention * in palliative phase of treatment * being considered for risk-reducing or reconstructive surgery within 1 year * concurrent psychological treatment * cognitive impairment precluding informed consent or participation
pilot randomized controlled study of the impact of medrhythms' mr-010 in acute stroke

Conditions: Stroke, Acute

Summary: the purpose of this clinical pilot study is to evaluate the effects of the mr-010 on tolerability, biomechanics and walking speed in the acute stroke care setting in addition to its impact on length of stay.


Eligibility criteria:
inclusion criteria: * must be 18 years of age or older. * must be able to read and speak english fluently. * be within 24 hours from admission for confirmed stroke event. * currently able to walk at a speed greater or equal to 0.4m/s, but less than 1.0m/s, as determined by a 10-meter walk test for comfortable walking speed (the average of three trials). * demonstrates some level of asymmetry in gait. * is expected to be discharged from the acute care setting requiring physical therapy per standard of care and participant has verbally committed to receiving at least one therapy session. * able and willing to consent with proposed study schema (verbal commitment), including consent to participate in communication with the treating clinician (as needed) during the study period. * score ≤1 on question 1b and a 0 on question 1c on the nih stroke scale. * able to safely participate in protocol-defined walking therapy sessions of 30-minute duration as determined by the investigator. exclusion criteria: * participant unable or unwilling to provide informed consent. * has a known history of neurologic (excluding stroke) injury. * has severe aphasia and/or a speech/language disorder, limiting ability to express needs and comprehend instructions. * has an external lower limb prosthetic ("artificial limb"). * has a hearing impairment. * had orthopedic surgery in the last year. * has co-morbidities that prevent participation in exercise (for example: musculoskeletal, cardiovascular, pulmonary and neurological - other than stroke). * vulnerable populations as deemed inappropriate for study by site principal investigator.

Keywords: rehabilitation
a post market clinical follow-up study on biomet microfixation htr pekk (midface), facial & mandibular plates.

Conditions: Tumor; Facial Fracture; Mandibular Fractures; Fibrous Dysplasia; Osteoma of Mandibular Condyle; Neuroma; Cleft Face; Hemifacial Microsomia; Treacher Collins Syndrome; Miller Syndrome; Nager Syndrome

Summary: this study will address medical devices manufactured by biomet microfixation (d.b.a. zimmer biomet) designed for fixation and stabilization of the facial and mandibular skeleton.

the subject devices are: * plates, screws, and primary instruments from the biomet microfixation facial plating system, including plates to be specifically used in orthognathic procedures * plates, screws and primary instruments for the mandibular plating system, including and a device intended to temporarily restore the functionality of the temporomandibular joint for patients whose natural condyle has to be resected, subsequent to a tumor ablation ("add-on condyle") additionally, a third device intended for the replacement of bony voids in the facial skeleton will be evaluated in this trial (htr-pekk- facial application).

Eligibility criteria:
inclusion criteria: 1. males or females 2. a patient who underwent one or more of the following surgical procedures completed between january 1, 2015 and december 31, 2019, with plates, screws, and or meshes from the biomet microfixation facial plating system: * repair of a facial fracture * repair of a facial osteotomy * reconstructive procedures of the facial skeleton * revision procedures where other treatments or devices have failed 3. available follow-up data at least at 30 days' post-operative exclusion criteria: 1. active or latent infection at the time of implantation 2. documented foreign body sensitivity 3. patients with limited blood supply, insufficient quantity or quality of bone (e.g., osteomalacia or a bone resorption condition such as paget's disease, osteoporosis, bone metastasis) 4. patients with documented mental or neurologic conditions who were unwilling or incapable of following postoperative care instructions

Keywords: facial plates mandibular reconstruction facial reconstruction condylar tumor orofacial cleft
camrelizumab in patients with unresectable hepatocellular carcinoma

Conditions: Unresectable Hepatocellular Carcinoma

Summary: primary liver cancer is the second most common cause of cancer death in china, and hepatocellular carcinoma (hcc) represents more than 80% of liver cancer cases. the majority of hcc cases present at an advanced stage, and are thus not amenable to surgery. immunotherapies, including pd-1 and pd-l1 inhibitors, alone or combined with other regimens, have shown encouraging clinical activity in unresectable hcc. camrelizumab, a humanised monoclonal antibody against pd-1, has been shown to block the binding of pd-1 to pd-l1 and consequently inhibit the immune escape of tumour cells， which has been approved for the second-line treatment of advanced hcc. this observational study aims to evaluate the safety and efficacy of camrelizumab in chinese unresectable hcc in the real world.

primary liver cancer is the second most common cause of cancer death in china, and hepatocellular carcinoma (hcc) represents more than 80% of liver cancer cases. the majority of hcc cases present at an advanced stage, and are thus not amenable to surgery. immunotherapies, including pd-1 and pd-l1 inhibitors, alone or combined with other regimens, have shown encouraging clinical activity in unresectable hcc. camrelizumab, a humanised monoclonal antibody against pd-1, has been shown to block the binding of pd-1 to pd-l1 and consequently inhibit the immune escape of tumour cells，which has been approved for the second-line treatment of advanced hcc. this multi-center, open-label, observational study aims to evaluate the safety and efficacy of camrelizumab in chinese unresectable hcc in the real world. this study also aims to evaluate the treatment of camrelizumab in subgroups, to provide information of treatment regimens and efficacy in clinical practice. the anticipated sample size is 1000, and the camrelizumab-based treatment will be determined by the investigator.

Eligibility criteria:
inclusion criteria: * 1. volunteer to participate in this study and sign an informed consent form; 2. age ≥ 18 years; 3. hepatocellular carcinoma confirmed/clinically confirmed by histopathology, cytology or imaging exclusion criteria: * 1. documented pregnant or breastfeeding women; * 2. patients who are participating in any interventional trials beyond clinical practice.
quality improvement precivityad clinician survey (quip i)

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia; Cognitive Decline

Summary: there is an important unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (mci) and early dementia. mci impacts 12-18% of people in the united states over age 60 and is often an initial clinical sign of alzheimer's disease (ad) (alzheimer's association, 2022). the precivityad test is an analytically and clinically validated blood test that aids healthcare providers in the diagnosis of ad in patients with mci and early-stage dementia. c2n has created a quality improvement (qi) survey to gather insight from clinicians as to the clinical effectiveness of the commercially available precivityad™ test, which identifies whether a patient with signs and symptoms of cognitive decline is likely to have amyloid plaques in the brain, a pathological hallmark of alzheimer's disease.

by gathering feedback from healthcare providers on patient selection, intended use, and anticipated outcomes and continued or revised care plans as a result of the test report, c2n can better understand the impact of the test results on diagnosis and patient management.

Eligibility criteria:
inclusion criteria: 1. memory specialist actively practicing in the united states. 2. practice includes individuals with mild cognitive impairment age \> 60 years 3. average patient volume \> 50 visits per week (all patients seen across practice) exclusion criteria: 1. other clinicians with a specialty outside of the field of memory specialists 2. principal investigator reserves the right to not include a clinician in the survey
transcultural validation of the oxford shoulder score for the french-speaking population

Conditions: Shoulder Pain

Summary: degenerative lesions of the shoulder occur very frequently and their incidence increases with age. the constant-murley score is currently considered the gold standard in europe to assess the shoulder and is widely used by the orthopaedic community to follow up on shoulder pathologies. however, healthcare professionals are taking an increasing interest in self-administered patient-reported out-come measures. several self-administered questionnaires are available to assess the shoulder. among these questionnaires, the oss (oxford shoulder score) is considered to be quick, simple, and reliable for the english-speaking population. this score was initially developed at the university of oxford in 1996. it is a self-administered questionnaire designed to evaluate pain and shoulder function through 12 questions. this score has since been adapted in different languages but not in french.

the aim was to develop a translation and a transcultural adaptation of the oss and to assess its validity in native french-speaker patients with shoulder pain.

Eligibility criteria:
inclusion criteria: * patients receiving chemotherapy for solid tumors in ambulatory medicine unit of the reims university hospital (france) between may 14, 2012 and july 31, 2013 * native french speakers exclusion criteria: * patients who presented shoulder's instability problems
diabeloop wp7 : crossover evaluation of the safety and the efficacy of artificial pancreas diabeloop (wp7)

Conditions: Closed Loop; Diabetes Mellitus, Type 1

Summary: the study will be conducted in crossover trial, with two 12-weeks periods separated by a wash-out period of at least one month. according to randomization ,patients will be provided with either diabeloop system or the usual system. patients will be trained for the use of blood glucose meter, of external insulin pump and diabeloop system. in both treatment periods, the same blood glucose meter will be used throughout the duration of the study. in two centers (centre hospitalier sud-francilien and grenoble), a pre-study will be performed during four weeks to improve the efficacy of diabeloop system with data collection, to test the manual settings by health care providers and patients and to check the good-working of the follow-up platform.


Eligibility criteria:
inclusion criteria: * type 1 diabetic patient for at least two years * patient treated by external insulin pump for at least 6 months * patient with hba1c ≤ 10%; dosage of less than 4 months done in analysis laboratory medical or equivalent. * patient requiring a daily dose of insulin ≤ 50 units * patient domiciled in an area with global system for mobile communication (gsm) * not isolated patient, not living alone, or having a person "resource" living nearby and having a phone and the key of its place of residence * patient not envisaging a journey outside france during the "closed-loop" period * patient aged over 18 years * patient affiliated to social security * patient who agreed to participate in the study and who signed an informed consent exclusion criteria: * patient with any serious illness that may impair study participation * patient having a treatment known to have a significant interference on the glycemia. * patient enjoying a measure of legal protection * pregnant woman or likely to be