Kornimate/medical-research-clean huggingface dataset:
compare outcomes of smg and cpap in osa

Conditions: Quality of Life; Sleep Apnea Syndromes

Summary: the objectives of this study is to compare short-term outcomes of cpap and adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. study design is a randomized cross-over trial during 6-week period of each treatment in 50 patients. primary outcomes are quality of life, degree of sleepiness, and severity of osa determined by fosq ess, and ahi or rdi, respectively.

the objectives of this study is to compare short-term outcomes of cpap and adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. study design is a randomized cross-over trial during 6-week period of each treatment in 50 patients. primary outcomes are quality of life, degree of sleepiness, and severity of osa determined by fosq ess, and ahi or rdi, respectively. wash-in period 2 weeks and wash-out periods 2 weeks are required before start each treatment.

Eligibility criteria:
inclusion criteria: 1. osa patients aged over 18 yo at siriraj hospital 2. ahi 5 - 30 events/ h or ahi \> 30 events/h but lowest o2 saturation \> 70% 3. positive consented form exclusion criteria: 1. patients with severe temporomandibular joint diseases or limited mandible advancement (\< 5 mm) 2. patients with severe periodontal diseases or inadequate teeth (\< 3 teeth in each quadrant) 3. patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, copd, cancers, cerebrovascular diseases, epilepsy, dementia, etc. 4. patients who could not tolerate the side effects of cpap or smg 5. patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.
the relationship between lower limb functionality, knee joint position sense, balance and falls in haemiplegic patients

Conditions: Haemiplegic Patients; Balance; Knee Joint Position Sensation; Lower Limb Functionality

Summary: stroke is defined as a neurological disorder attributed to acute focal damage of the central nervous system from a vascular cause, including cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. the world health organisation defines stroke as a focal and sometimes global impairment of cerebral function that lasts longer than 24 hours or ends in death, develops rapidly, has no demonstrable cause other than a vascular cause. evaluation of muscle strength and balance ability of affected patients is critical for the recovery of lower extremity motor functions. proprioception encompasses various sensory perception modalities such as force, effort, movement and limb position. impairment of sensory function in patients with haemiplegia can hinder the ability of muscles to recover during walking. accurate and effective assessment of gait and balance functions and their subsequent improvement is one of the primary goals of stroke rehabilitation programmes. studies comparing the effects of lower extremity functionality and knee joint position sense on balance and falls are available in various versions in the literature. however, there is no study in which 'restorative therapies rt300 leg/arm/cor' device was used to measure functionality, 'humac norm isokinetic machine' was used to measure knee joint position sense, and 'tecno body prokin isokinetic balance system' was used to measure balance in a single simultaneous study. therefore, the aim of this study was to investigate the relationship between lower limb functionality and knee joint position sense with balance and fall parameters in patients with hemiplegia using various devices.


Eligibility criteria:
inclusion criteria: * individuals over 18 years of age * volunteering to participate in the study exclusion criteria: * hip and knee prosthesis * being diagnosed with vertigo * having a history of serious neurological diseases such as parkinson's disease, multiple sclerosis except hemiplegia * having a previous operation for the lower limb * poor co-operation

Keywords: proprioception joint position sense hemiplegia lower limb functionality balance fall
tuberculosis in a multiethnic inner city population

Conditions: Acquired Immunodeficiency Syndrome; HIV Infections; Lung Diseases; Tuberculosis; Mycobacterium Tuberculosis

Summary: to determine the incidence of tuberculosis in an inner city population, identify risk factors for tb, describe the natural history in adults and children, evaluate the effect of mycobacterium tuberculosis (mtb) co-infection on the progression of human immunodeficiency virus disease, and determine factors that contribute to compliance and non-compliance with prophylaxis and treatment.

background: the research provided urgently needed information regarding incidence, risk factors, natural history, molecular epidemiology, treatment, and prevention of tuberculosis in an especially vulnerable multi-ethnic inner-city population with a high hiv seropositivity rate. the study was part of a collaborative project on minority health, the epidemiology, drug resistance, and therapy of tuberculosis in a multi-ethnic inner city population with a high hiv seropositivity rate. the 1993 report of the committee on appropriations, house of representatives, encouraged the nhlbi to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. the concept for the initiative was developed by the nhlbi staff and approved by the september 1992 national heart, lung, and blood advisory council. the request for applications was released in october 1992. design narrative: the study was conducted prospectively and retrospectively in three groups of patients: intravenous drug users and their sexual contacts in an already-recruited cohort; children who received their primary care at bellevue hospital medical center; and bellevue hospital center inpatients with tb and outpatients who underwent prophylactic treatment. in addition to environmental risk factors (e.g., hopelessness, cohabitation with tuberculosis patients and injected drug use), host factors were investigated, including: hiv infection; immune status among hiv- seropositive persons, as indicated by quantitative p24 antibodies; cd4, cd8, and gammadelta t cell counts; and race, age, and nutritional status. incidence and risk-factors in the cohort were assessed by interview, blood draw, ppd screening, medical record review, and anergy panel. natural history and impact on hiv disease in adult and pediatric populations were assessed by interviews, clinical screening and laboratory measures. drug sensitivity testing and rflp typing of specimens from the two populations were conducted, respectively, at the bellevue mycobacteriology lab and the public health research institute. factors affecting treatment compliance were assessed by self-administered questionnaire.

Eligibility criteria:
no eligibility criteria
a study of hs-20110 in participants with advanced solid tumors

Conditions: Solid Tumors

Summary: this is an open-label, multicenter study to evaluate the safety and tolerability of hs-20110 in participants with advanced solid malignant tumors


Eligibility criteria:
inclusion criteria: 1. males or females, aged ≥ 18 years. 2. participants with pathologically (histologically or cytologically) confirmed advanced solid tumors. 3. participants have at least 1 target lesion other than cns lesions according to recist 1.1. exclusion criteria: 1. participants have received or are receiving the following treatment: 1. drug therapy targeting cdh17 (such as small molecule targeted drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, or chimeric antigen receptor t cells). 2. anti-tumor drugs within 14 days prior to the first dose of study treatment; any other imps or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment. 3. local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment. 4. major surgery within 4 weeks prior to the first dose of study treatment. 5. participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome p450 (cyp) 3a4, strong inhibitors or strong inducers of cyp2d6, p-glycoprotein (p-gp), breast cancer resistance protein (bcrp) or drugs with a narrow therapeutic range that are sensitive substrates of p-gp or bcrp within 7 days prior to the first dose of the imp. participants who need to receive these drugs during the study period should also be excluded. 6. current use of drugs known to prolong the qt interval or that may cause torsade de pointes. participants who need to receive these drugs during the study period should also be excluded. 7. live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose. 2. participants who have any grade ≥ 2 residual toxicity according to common terminology criteria for adverse events (ctcae, version 5.0) from prior therapies (except alopecia and residual neurotoxicity). 3. inadequate bone marrow reserve or hepatic and renal functions. 4. participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins. 5. participants who are allergic to any component of hs-20110.
a study of anal cancer development in hiv infected people

Conditions: HIV Infections; Anus Neoplasms

Summary: the purpose of this study is to compare the development of abnormal cell growth or cancer in the anal region of individuals who are receiving one of two different anti-hiv treatment strategies.

human papillomavirus (hpv) is a common viral infection among men and women. individuals with hpv are at risk for anal dysplasia, a condition that may lead to anal cancer. it has been observed that hiv progresses more rapidly in individuals coinfected with hpv and hiv, compared to people with either disease alone. studies that have investigated the effect of highly active antiretroviral therapy (haart) on the progression of anal dysplasia have been contradictory and inconclusive. the role of cd4 count and hiv suppression and their contributions to the progression of anal disease needs to be determined. this trial is a substudy of a study of management of antiretroviral therapy (smart). in the smart study, patients will participate in one of two strategies: a drug conservation (dc) strategy and a viral suppression (vs) strategy. participants in the dc group will stop or defer haart, then receive episodic haart treatment for the minimum time needed to maintain a cd4 cell count of at least 250 cells/mm3. participants in the vs group will receive haart to maintain a viral load as low as possible, regardless of cd4 count. this study will compare the times to development of high-grade anal dysplasia or anal cancer in participants who are currently enrolled in the smart study. patients will participate in this substudy and the main smart study at the same time. at the baseline visit, participants will undergo an anal swab; some female participants will have a cervical swab as well. participants will provide a detailed sexual history including sexually transmitted infections, a history of anal-related conditions, and a history of alcohol and recreational drug use. these procedures will be repeated at each annual follow-up visit. some participants may undergo additional anal cytology and high-resolution anoscopy with biopsy. participants will be followed until they develop high-grade anal dysplasia or anal cancer or when the smart study closes, whichever comes first.

Eligibility criteria:
inclusion criteria: * coenrollment in the smart study * normal anal cytology result. if baseline anal cytology is abnormal, high-resolution anoscopy must be performed and specimens must be obtained. * parent or guardian willing to provide informed consent, if applicable exclusion criteria: * current or prior history of anal or cervical cancer * permanent or irreversible bleeding disorder that would interfere with biopsy of the anal canal

Keywords: treatment experienced hiv hpv antiretroviral therapy, highly active papillomavirus, human
radiofrequency treatment of chronic pelvic pain management in interstitial cystitis

Conditions: Interstitial Cystitis, Chronic

Summary: interstitial cystitis/painful bladder syndrome is a collection of symptoms that includes urinary urgency, urge incontinence, nocturia, and painful urination. various treatment modalities are utilized in the management of the disease. superior hypogastric plexus block, which is used in the treatment of chronic pelvic pain, is one of these treatment methods. additionally, tibial nerve stimulation is used in the treatment of urinary symptoms. this study aims to compare the effectiveness of superior hypogastric plexus pulsed radiofrequency and adjunctive transcutaneous tibial nerve stimulation in the treatment of patients with interstitial cystitis


Eligibility criteria:
inclusion criteria: * patients aged 18-65 years * diagnosed with interstitial cystitis and experiencing symptoms for at least 3 months exclusion criteria: * pregnancy or breastfeeding * patients with renal, hepatic, cardiovascular, or psychiatric diseases * additional interventional treatments within the first 3 months after the procedure * a history of previous surgery or trauma
the safety of ovarian preservation in stage ia endometrial carcinoma

Conditions: Endometrial Neoplasms

Summary: this randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (bso) for patients with stage ia endometrial carcinoma.


Eligibility criteria:
inclusion criteria: * figo stage: ⅰa, endometrial carcinoma; * female, chinese women; * premenopausal women； * ≤ 50 years old; * pathological diagnosis by curettage/hysteroscopy : g1 * no prior treatment; * provide written informed consent. exclusion criteria: * the suspicious metastasis of ovarian; * family history of ovarian cancer; * suffering from other malignancies; * concurrently participating in other clinical trials; * unable or unwilling to sign informed consents; * unable or unwilling to abide by protocol.
a study to compare the safety and drug levels in blood when using various forms of gsk189075 given to healthy subjects

Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Summary: the purpose of this research study is to look at concentrations of gsk189075 in blood when different long and short acting forms of the drug are taken by mouth. the results will help to decide whether a long-acting form of gsk189075 can be made. the effects of the drug on the body and safety will also be studied.


Eligibility criteria:
inclusion criteria: * are a healthy, non-smoking adult, 18 to 55 years old. * are not overly thin or overly heavy for your height. * are a female who is unable to have children, or is willing to use birth control throughout the study. * are willing and able to follow all study-related instructions provided by the site staff. - are willing to provide signed consent. exclusion criteria: * are a pregnant or a nursing female. * have a past or current disease such as heart, liver, kidney, blood, brain, or other disease. * have had certain infections within 4 weeks before the expected the first dose of study drug. * have hiv or hepatitis, or have alcohol in your system at the screening visit. * have a history of alcohol abuse. * have been in another research study in the last month or have taken certain medications in the 2 weeks before study drug would be taken. * have laboratory tests that are outside the normal range.

Keywords: pharmacokinetics, healthy male and females, pharmacodynamics
cell-free dna from junction of hepatitis b virus integration in hcc patients for monitoring post-resection recurrence

Conditions: Hepatocellular Carcinoma

Summary: hbv dna integration has been found in the chromosomes of about 90% of hbv-related hcc and the integration site is unique to individual hcc. the virus-host chimera dna (vh-dna) from hbv integration sites in hcc a reliable evidence even in the patient with a tiny tumor which is not large enough to be detected by the image scan. the goal of this observational study is to compare the prediction ability of vh-dna with the other biomarkers for monitoring the recurrent of hbv-related hcc. the main questions that aim to answer are the sensitivity and specificity of vh-dna/afp/alp-l3/pivka-ii/tertc2280 when the gold standard is the guideline of hcc diagnosis. the surgical tissues and plasma samples from the participants would be collected undergoing the hcc recession surgery when joining the study at the beginning, in order to identify the hbv integration in tumor by capture ngs and quantify the specific vh-dna in plasma by ddpcr as personalized biomarkers for minimal residual disease (mrd) monitoring. moreover, the consistency of vh-dna from tumor will be validated by pre-operative plasma. then the participants will be asked to performed the visit at 2, 5, 8, 11, 14 months after the hcc recession surgery. the plasma sample for vh-dna/afp/ afp-l3/ pivka-ii/ tertp c228t testing and the image data from ultrasound, ct or mri would also be collected at these visits. when the vh-dna testing result is positive and there is no recurrence at 14 months after the hcc recession surgery, some participants will be asked to followed at 17, 20 months. researcher will compare the sensitivity, specificity and predict day of vh-dna with afp/ afp-l3/ pivka-ii/ tertp c228t as a biomarker for hcc surveillance. the true value of this novel hbv chimera vh-dna will be revealed. the results will also support to use for monitoring post-operative recurrence. in addition, the investigators will explore the performance of tertp c228t mutation from non-hbv hcc patients. as a different target of ctdna for hcc, tertp c228t will be identified using surgical tissues from hcc patients, and plasma samples from the same patient before/after operation will be tested by ddpcr . it will be evaluated that tertp c228t is predictive or not for recurrence monitoring of hcc.


Eligibility criteria:
inclusion criteria: 1. ≥20 years old. 2. subject who is diagnosed with hcc 3. subject who is scheduled to undergo hepatic resection or liver transplant. exclusion criteria: 1. subject who should not treat with the contrast media (for imaging) 2. active malignancy (still under intensive cancer treatment or considered in progression) or disease free interval less than one year before entering the study.

Keywords: hepatocellular carcinoma hepatitis b virus biomarker cell-free dna cfdna circulating tumor dna ctdna virus-host chimera dna chimera dna
feasibility of self-treatment of painful diabetic neuropathy using electrical vasomotor nerve stimulation

Conditions: Painful Diabetic Neuropathy

Summary: electrical stimulation with evns (electrical vasomotor neuro stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in painful diabetic neuropathy (pdn). however, due to the impaired mobility from diabetic neuropathy, a part of subjects did not finish the 10 days treatment in the outpatient clinic. another part of the target group decided not to participate at all for the same reason. the current study investigates the feasibility, safety and performance of a newly developed evns device, called releaf™, optimised for home treatment,


Eligibility criteria:
inclusion criteria: * painful diabetic neuropathy (dn4 positive) and insufficiently treated with any combination of 2 of the following drugs: duloxetine (cymbalta), venlafaxine (efexor), ami- or nortriptyline, gabapentine, pregabaline (lyrica) or the use of carbamazepine or capsaïcine (qutenza). * both feet are present * able and willing to complete the treatments in 10 days in a row and completion of questionnaires. * being in a mental and physical state to perform home self-treatment with releaf™ for 10 consecutive days, if necessary with adequate assistance of caregiver. * being in a mental and physical state to understand and complete the informed consent form as well as the research questionnaires. exclusion criteria: * in case of other evident causes for painful neuropathy, * currently participating in another interventional investigational study * significant peripheral arterial disease, * active foot ulceration or other skin conditions that prevent the application of electrodes on the skin * current alcohol or other substance abuse (use of alcohol over the recommended limits of less than 21 units of alcohol per week in men and 14 units in women, trimbos intitute), * epilepsy, * pregnancy, * presence of a medical device based on electrical stimulation, cardiac pacemaker and/or implantable cardioverter defibrillator or any other active implant * allergy to electrode contact area or to the adhesive substance of the electrode.
quadruple immunotherapy for neuroblastoma

Conditions: Neuroblastoma Recurrent

Summary: this is a single-arm clinical trial to evaluate the efficacy and safety of quadruple immunotherapy with natural killer (nk) cells, anti-gd2 antibody, cytokines (interleukin-2 (il-2) and granulocyte-macrophage colony stimulating factor (gm-csf)) and retinoid x receptor gamma (rxrg) agonist spironolactone for paediatric patients with relapsed or refractory neuroblastoma.

included patients will receive intravenous infusion of donor nk cells on day 0, and anti-gd2 antibody (dinutuximab) on day -6 to day -2. il-2 will be given subcutaneously on day -1, day +1, day +3, day +5, day +7, and day +9. subcutaneous injection of gm-csf will be started on day 0, given daily till neutrophil count \>1000/mm3. spironolactone will be started orally on day -1, given three times daily till cessation of gm-csf. alternative anti-gd2 antibody (naxitamab) can be used instead of dinutuximab, to be given on day -5, day -3, day +1 and day +3.

Eligibility criteria:
inclusion criteria: * relapsed or refractory neuroblastoma * adequate organ function: creatinine clearance ≥40 ml/min/1.73m2, total bilirubin ≤3 times upper limit of normal and alt ≤500 iu/l, left ventricular shortening fraction ≥25%, and oxygen saturation ≥92% in room air * karnofsky or lansky performance status score ≥50 * has an appropriate hla-haploidentical nk-cell donor available exclusion criteria: * pregnant or lactating woman * hiv infection * patients for whom conventional treatment is deemed more appropriate * patients who are unlikely to benefit, e.g., terminal malignancy with life expectancy \<1 month
multidisciplinary collaboration care in pulmonary arterial hypertension (pah)

Conditions: Hypertension, Pulmonary

Summary: pulmonary arterial hypertension (pah) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. however, adherence to treatment has not been assessed in such patients. the investigators developed a collaborative care model involving clinical pharmacists in pah. the objective of this work is to evaluate the impact of such model of care on medication errors and adverse events, quality of life and clinical criteria. this randomized multicentre controlled study will include approximately 100 pah patients (nyha ii to iv). after inclusion, patients will receive either collaborative care including consultations with specialized pharmacist and nurse, or classic follow-up. each patient will be followed during 18 months from the date of inclusion. the investigators hope to show the positive impact of a collaborative care model in pah. more specifically, the investigators aim to show the interest of long-term patient education to improve patient safety related to drugs, but also their quality of life, and have preliminary data about usual clinical criteria.


Eligibility criteria:
inclusion criteria: * age over 18; * pulmonary arterial hypertension (nyha ii to iv); * any specific pah treatment or oral anticoagulant. exclusion criteria: * patients under 18 or protected by law; * patients who do not speak/understand french; * pregnancy; * patients enrolled in other clinical trials.

Keywords: patient education drug toxicity