Kornimate/medical-research-clean huggingface dataset:
randomized control trial copper intrauterine device and depo-medroxyprogesterone acetate (dmpa) of hiv+ women in malawi

Conditions: HIV

Summary: the iud is an extremely effective method of contraception yet few women use it worldwide. considered safe to use in hiv+ women, few studies have evaluated its use among those using antiretroviral therapy. the only prior randomized trial looking at the iud compared to hormonal contraception noted a high rate of iud discontinuations. understanding iud acceptability and continuation is critical to improve utilization. * objective 1: determine who medical eligibility and the willingness for iud placement * objective 2: compare method-related side effects and adverse events * objective 3: assess the 1-year acceptability and continuation rates methods: to address our objectives the investigators have designed a two phase study: * a cross-sectional screening to evaluate contraceptive medical eligibility and desirability * a randomized controlled trial that will compare acceptability and adherence to dmpa compared to the copper iud: enrolling 200 women stable on antiretroviral therapy to follow for 1 year


Eligibility criteria:
inclusion criteria: * can provide informed consent * women ages 18-45 * known hiv + status on antiretroviral therapy for at least 6 months * not currently pregnant * willing to initiate either dmpa or cut380a-iud. women currently using dmpa or cut380a-iud will be excluded * do not desire to become pregnant within next 12 months * intend to stay in lilongwe region for the duration of the study * no known uterine anomalies based upon history * greater than or equal to 4 weeks post partum * no known or suspected genital tract cancer * no evidence of current pelvic inflammatory disease or cervicitis. women with cervicitis at the time of examination will be treated with antibiotics and eligibility will be reassessed at a follow-up visit at least 7 days after treatment * no pelvic inflammatory disease within prior 3 months * no contraindications to dmpa or the cut380a-iud per the who medical eligibility criteria or malawi national reproductive health service delivery guidelines, 2007 * based on clinical assessment, no condition that would preclude start of study intervention exclusion criteria: * women ages younger than18 or older than 45 * known hiv + status on antiretroviral therapy less than 6 months or not on antiretroviral therapy * pregnant * uterine anomaly * less than 4 weeks post partum * suspected genital tract cancer inclusion criteria: •current sti or pid

Keywords: acceptability and adherence to methods
lung ultrasound changes in covid 19 patients discharged from hospital

Conditions: Covid19; Coronavirus; Coronavirus Infection; SARS-CoV Infection

Summary: lung ultrasound has been used to help diagnose covid-19 as an alternative to ct scanning and chest x-ray. ct scanning is onerous and there are difficulties taking critically unwell patients there as well as decontamination issues. chest x-ray misses up to 40% of covid diagnoses. although lung ultrasound can diagnose, the investigators do not know how long these lung ultrasound changes last. the investigators would like to follow up patients to characterise the pattern of changes and how long they last. this is particularly important given a potential second surge of covid-19 is looming and the investigators would like to know if lung ultrasound changes are new or old in patients presenting during this second wave and in the future.

ultrasound has been invaluable during this pandemic to diagnose covid-19. the investigators have used it alongside ct scanning to rationalise the number of ct scans especially when patients are unstable. the investigators do not know how long these changes last on lung ultrasound after discharge and the investigators wish to study this. this is because patients will start presenting shortly who have a history of covid-19 with acute medical problems and if the investigators are to use lung ultrasound again the investigators would like to know whether the changes the investigators see are new or old. this is vitally important before a second surge and especially so before winter. this may also facilitate triage of patients from the front door in the emergency department to different areas (such as covid-19 zones or clean areas).

Eligibility criteria:
inclusion criteria: * 18 years old or older * confirmed covid-19 positive with changes on cxr or ct scan * having had an initial lung ultrasound in the emergency department when they were first admitted into the hospital. exclusion criteria: * pre-existing lung disease * heart failure * under 18 years old.

Keywords: coronavirus covid-19 lung ultrasound respiratory
adding amantadine to pregabalin on occurrence of post-thoracotomy pain syndrome

Conditions: Amantadine; Pregabalin; Post-thoracotomy Pain Syndrome

Summary: this study aims to evaluate the additive effect of amantadine to pregabaline in the development of post-thoracotomy pain syndrome.

lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the primary therapeutic option. hence, the number of thoracotomy procedures is progressively increasing, as well as the development of post-thoracotomy pain syndrome (ptps). pregabalin is one of the drugs that can reduce the excitability of the dorsal horn neurons. it is a γ-aminobutyric acid analogue that binds to α2-δ subunits of the voltage-gated calcium channels in the central nervous system. amantadine (1-aminoadamantane) is nmda receptor antagonists. nmda receptors were found to have role in the development of central sensitization, acute opioid tolerance, and opioid induced hyperalgesia.

Eligibility criteria:
inclusion criteria: * age (18-65) years. * both sexes. * american society of anesthesiologists (asa) physical status ii, iii. * body mass index (bmi): (20-40) kg/m2. * cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or other lung resection procedures. exclusion criteria: * patients with known sensitivity or contraindication to drug used in the study. * history of psychological disorders and/or chronic pain and drug abuse patients. * previous administration of antidepressants, anticonvulsants, or opioids before surgery. * patient refusal. * severe respiratory or cardiac disorders. * advanced liver or kidney disease.
a study in healthy men and women to test which effects memantine and bi 425809 have on each other

Conditions: Healthy

Summary: investigate the effect of steady state exposures of memantine on the steady-state pharmacokinetics of bi 425809 and vice versa in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (bp, pr), 12-lead ecg, and clinical laboratory tests * age of 18 to 50 years (inclusive) * bmi of 18.5 to 29.9 kg/m2 (inclusive) * signed and dated written informed consent prior to admission to the study, in accordance with gcp and local legislation * male subjects, or female subjects who meet any of the following criteria from the first administration of trial medication until 30 days after trial completion: * use of adequate contraception that does not contain hormones, i.e. nonhormonal intrauterine device plus condom * sexually abstinent * a vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) * surgically sterilised (including hysterectomy) * postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of fsh above 40 u/l and estradiol below 30 ng/l is confirmatory) exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 50 to 90 bpm * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * further exclusion criteria apply
transcranial direct current stimulation for post-stroke fatigue

Conditions: Fatigue; Stroke Rehabilitaion

Summary: the investigators hypothesize that delivery of anodal tdcs to the left frontal head region will reduce fatigue severity following stroke.

the purpose of this study is to investigate transcranial direct current stimulation (tdcs) as a home-based non-pharmacologic intervention for post-stroke fatigue (psf). investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. after a baseline assessment, the tdcs device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (dlpfc), for a total of two weeks. follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). neuroimaging will be completed at baseline and post-treatment.

Eligibility criteria:
inclusion criteria: * male or female patients aged \>18 years * greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (ct or mri). * fatigue severity score average \>4 (severe fatigue) * willingness to remain stable on pharmacologic therapy through the duration of the study. * availability of a caregiver, family member, or friend to be present during the administration of the tdcs intervention. exclusion criteria: * metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, dbs stimulator) * history of seizure * history of moderate to severe traumatic brain injury * a score of 10 or more on the phq-9 or gad-7 scale, suggestive of moderate to severe depression/anxiety. * a score of less than 21 on the moca suggesting major neurocognitive disorder. * signs of skin rash, infection, or laceration in the supraorbital region where the tdcs will be applied. * inability to provide informed consent * other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.
safety and performance of the steroid-releasing s8 sinus implant

Conditions: Chronic Sinusitis

Summary: the purpose of this study was to assess the safety and performance of the steroid-releasing s8 sinus implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.

the s8 pk study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. the s8 pk study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (mf) by measuring plasma mf and cortisol concentrations through 30 days post-procedure.

Eligibility criteria:
key inclusion criteria: * 18 years of age or older * diagnosis of chronic sinusitis * prior bilateral total ethmoidectomy * recurrent sinus obstruction due to polyps grade 2 or higher key exclusion criteria: * required use of mometasone furoate within 2 weeks prior to implant procedure * significant scarring or adhesions of the sinus
utility of restrata with split-thickness skin graft to reconstruct the forearm donor site

Conditions: Head and Neck Cancer

Summary: adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the restrata graft in combination with split-thickness skin graft for reconstruction. photos will document whether the restata graft aids in the healing.


Eligibility criteria:
inclusion criteria: * all patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap. * photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient. exclusion criteria: * active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications or medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc). * diabetes mellitus with most recent hemoglobin a1c ≥10.0 within 30 days prior to surgery. * morbid obesity (bmi \>40). * inability to maintain wrist immobilization for full planned period. * severe malnutrition (prealbumin levels \<10 mg per dl within 30 days prior to surgery or bmi \<15 (very severely underweight). * other conditions felt to significantly impair wound healing per surgeon discretion
non-invasive tools for psvd diagnosis

Conditions: Non-Cirrhotic Portal Hypertension; Porto-Sinusoidal Vascular Diseases

Summary: patients treated with platinum-based chemotherapy drugs have the probability of developing psvd. the diagnosis of psvd depends on liver biopsy. in addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of psvd. many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. the purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of psvd and to search for effective biomarkers for the diagnosis of psvd through a single-center, prospective, observational study.

psvd is a supplement to non-cirrhotic portal hypertension and is defined as a class of diseases with characteristic pathological changes based on portal vein or hepatic sinuses abnormalities without cirrhosis. some patients treated with platinum-based chemotherapy drugs will develop psvd, which is clinically manifested as portal hypertension related complications. the diagnosis of psvd depends on liver biopsy. in addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of psvd. however, liver biopsy and pressure measurement are invasive methods. many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. the purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of psvd and to search for effective biomarkers for the diagnosis of psvd through a single-center, prospective, observational study.

Eligibility criteria:
inclusion criteria: 1. received platinum chemotherapy for organ tumors; 2. ages 18-80; 3. sign the informed consent voluntarily. exclusion criteria: 1. liver pathology suggested cirrhosis; 2. underwent liver transplantation; 3. combined with hepatocellular carcinoma exceeding milan criteria; 4. complicated with severe heart, kidney, or lung failure; 5. pregnant or lactating women; 6. data is seriously missing; 7. patients were judged not suitable for participation in this study by the researchers.
topotecan pharmacokinetic characterization study

Conditions: Cancer

Summary: a multi-center, open label, single dose phase i pharmacokinetic (pk) characterization of weekly iv (intravenous) topotecan given at 4mg/m2. 15 patients will be evaluated.


Eligibility criteria:
inclusion criteria: * written informed consent * performance status of 0, 1, or 2 on the eastern co-operative oncology group (ecog) scale * predicted life expectancy of at least 3 months * subjects with histologically or cytologically confirmed advanced solid tumors who have failed conventional therapy for their tumor type or have a tumor type for which no standard effective therapy exists; or patients for whom single-agent topotecan therapy is suitable * at least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery * must be free of post-treatment side effects (with the exception of alopecia) * no concurrent chemotherapy, biologic therapy or radiotherapy is allowed * hemoglobin = 9.0 g/dl * wbc = 3,500/mm3 \[= 3.5 x 109/l\] * neutrophils = 1,500/mm3 \[= 1.5 x 109/l\] * platelets = 100,000/mm3 \[= 100.0 x 109/l\] * calculated creatinine clearance=60 ml/min using the cockcroft-gault formula * serum bilirubin \< 2.0 mg/dl (34 µmol/l) ast, sgpt/alt and alkaline phosphatase \< 2 times the upper limit of normal if liver metastases cannot be visualized by abdominal computed tomography (ct) or magnetic resonance imaging (mri scan) * if liver metastases are present, subjects with \< 5 times the upper limit of normal are eligible to participate exclusion criteria: * women who are pregnant or lactating * women subjects of childbearing potential who refuse to abstain from sexual intercourse or practice adequate contraception. childbearing potential is defined as women who are not surgically sterilized (i.e. have not had a hysterectomy, bilateral oophorectomy \[ovariectomy\], or bilateral tubal ligation) or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study). * men unwilling to abstain from sex or use effective contraception during the study and for 3 months following completion of topotecan treatment * subjects with uncontrolled emesis, regardless of etiology * active infection * concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk * treatment with another investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer) * history of allergic reactions to compounds chemically related to topotecan.

Keywords: chemotherapy recurrent refractory research cancer pharmacokinetics
prevalence and clinical course of chronic hep b infection in ibd and rheumatologic disease

Conditions: Inflammatory Bowel Disease; Crohn Disease; Ulcerative Colitis; Rheumatic Diseases; Hepatitis B, Chronic

Summary: this study aims to determine the prevalence of hbv infection in patients with ibd and rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load and clinical course of ibd patients.

the incidence of inflammatory bowel disease (ibd) has been increasing in hong kong. the management of inflammatory bowel disease involved the use of immunosuppressant, however, the use of immunosuppressant in patients with hepatitis b infection has been associated with hepatitis b reactivation. it is estimated that around 7% of the hong kong population is infected with hbv. the information on the prevalence of hepatitis b in ibd patients in hong kong is lacking. moreover, limited information is available on the effect of different immunosuppressive regimens given for longer periods of time in lower doses in patients with chronic hbv infection and ibd. there is therefore a need to determine the incidence and predictive factors for hbv reactivation in these patients. rheumatologic diseases, including systemic lupus erythematous, rheumatoid arthritis, psoriasis and anklyosing spondylitis are inflammatory conditions which commonly affect the locomotors system as well as other organs. epidemiological data from china have suggested that patients with ankylosing spondylitis have a higher risk of hepatitis b infection; while the rates of hepatitis b for those with rheumatoid arthritis, and other spondyloathropathies are similar to that of the general population. however, there are no such local data in hong kong aspect. this study aims to determine the prevalence of hbv infection in patients with ibd and rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load and clinical course of ibd patients.

Eligibility criteria:
inclusion criteria: * all ibd and rheumatologic patients aged 18 years or older exclusion criteria: * lack of consent * patients with evidence of other chronic liver disease,metabolic syndrome, men consuming more than 30 g of alcohol per day and women consuming more than 20 g of alcohol per day, patients with liver decompensation, hcc, previous liver surgery or liver transplantation
a single hyajoint plus combined with a single ppr versus a single prp for knee oa

Conditions: Knee OA

Summary: intraarticular hyaluronan or platelet-rich plasma (prp) is each effective in the treatment for knee osteoarthritis (oa). the efficacy of combined hyaluronan with prp for knee oa remained unclear. this study aimed to investigate the efficacy of a single intraarticular hyaluronan (hyajoint plus) combined with a single prp versus a single intraarticular prp in patients with knee oa.

intraarticular ha or prp has been used for knee oa for years. combined ha and prp has not been widely used for oa because of lack of clinical evidence. based on in vitro and animal studies, combining ha and prp may benefit from their dissimilar biological mechanisms for tissue repair and have potentials to synergistically promote cartilage regeneration, inhibit oa inflammation, modulate the disease process, and improve joint homeostasis in oa. combination of ha and prp has much potential for the treatment of oa, but the clinical evidence of this combination remains unclear. the purpose of this study was to investigate the efficacy and safety of combined a single crosslinked ha (hyajoint plus) with a single prp versus a single prp alone in patients with knee oa.

Eligibility criteria:
inclusion criteria: * aged 20-75 years;symptomatic knee oa \> 6 months despite conservative treatment such as oral analgesics, nsaids and/or physical therapy;kellgren-lawrence grades 2 knee oa on radiographs taken within the previous 6 months;average pain at walking \> 30 mm on a 100-mm visual analog scale (vas);radiological evidence of bilateral knee oa was accepted if global pain vas in the contralateral knee\< 30 mm. exclusion criteria: * previous orthopedic surgery on the spine or lower limbs disabling oa of either hip or foot knee instability, apparent joint effusion or marked valgus/varus deformity known allergy to hyaluronan products women ascertained or suspected pregnancy or lactating intraarticular injections into the knee in the past 6 months any specific medical conditions (rheumatoid arthritis, active infections, severe cardiovascular diseases, autoimmune diseases, hemiparesis, neoplasm, etc.) that would interfere with the assessments

Keywords: hyaluronan knee osteoarthritis platelet-rich plasma