Kornimate/medical-research-clean huggingface dataset:
the efficacy of wet cupping on blood pressure among hypertension patients

Conditions: Hypertension

Summary: this research proposal is submitted to fulfill the requirement of the phd degree of community medicine saudi board at the joint program of family and community medicine in jeddah, saudi arabia. background: cupping is an ancient treatment remedy that has been used for many centuries in many parts of the world. in the middle east, wet cupping "hijama" is still a popular treatment because of its religious background. despite of that, it still has little scientific evidence that proves its efficacy. many hijama healers claim that they have observed dramatic improvement in blood pressure control of hypertension patients. not many studies support that. this study should help to prove or disprove this hypothesis. objectives: * to determine the efficacy of wet cupping on blood pressure among high blood pressure patients. * to assess the incidence of wet cupping side effects in the intervention group. methods: the study design is a randomised controlled trial. there will be an intervention group of high blood pressure patients who will perform hijama in addition to their usual management, and a control group of high blood pressure patients who will receive their usual anti-hypertension management only. there will be 8 weeks follow up period. after that, data entry, analysis and interpretation will take place. hypothesis: wet cupping has an effect on blood pressure in adult hypertension patients


Eligibility criteria:
inclusion criteria: * high bp at the time of the study (sbp 140 mmhg or more and/or dbp 90mmhg or more). for patients with dm, high bp is defined as sbp 130 mmhg or more and/or dbp 85mmhg or more. * age between 19 and 65 years old. * males and females exclusion criteria: * grade iii hypertension (sbp 180 mmhg or more and/or dbp 110 bp or more). * patients with very high added risk,according to the saudi hypertension management guidelines. by excluding the patient who have associated clinical conditions which are: cerebrovascular disease, heart disease, renal disease, peripheral vascular disease and advanced retinopathy. * patients with secondary hypertension. * pregnant women. * if the patient performed dry cupping, wet cupping or acupuncture during the past 6 months.
clinical and economic impact of interventions by a clinical pharmacist on antibiotic use on surgical wards

Conditions: Bacterial Infections

Summary: the purpose of this study is to establish the impact of a pharmacist's recommendations regarding choice, dosing and duration of antibiotic therapy on quality and cost of antibiotic treatment on surgical wards.

inappropriate or incorrect use of antibacterials exerts selection pressure on pathogens potentiating emergence of resistance, puts patients at risk for unnecessary adverse drug reactions and potentially prolongs the length of stay in hospital thus increasing healthcare costs. in an effort to improve the quality of antibiotic drug therapy on surgical wards of a large university hospital, specific consulting by a clinical pharmacist was established. the objective of this study is to assess the impact of pharmaceutical consulting on the quality and costs of antibiotic use in surgical wards. comparison: within a control period the current pattern of antibiotic use is monitored. during the intervention period, the impact of the interventions made by the clinical pharmacist on antibiotic use is examined. one ward serves as a parallel control group; no intervention is being made on this ward throughout this study.

Eligibility criteria:
inclusion criteria: * female and male patients receiving antibiotics for a proven or suspected infection on designated surgical wards exclusion criteria: * patients under 18 * patients unable or unwilling to consent to their data being evaluated * patients receiving antibiotics perioperatively as prophylaxis * patients receiving antibiotics for less than 48hrs

Keywords: antibacterial agents surgery pharmacist economics, pharmaceutical
prospective study of mothers' and infants' social and epidemiologic determinants of health

Conditions: Infertility, Female

Summary: the goal of the promise study is to determine how pre-conception lifestyle factors (e.g., sleep, nutrition, physical activity) affect short- and long-term reproductive outcomes.

the overall goal of the promise study is to identify strategies to improve health outcomes for women and their children. the proposed study is important and novel as it aims to capture women before they are pregnant. current research on maternal and child health often focuses on women who are already pregnant. this time period is likely too late to make a meaningful clinical impact on long term maternal and child health outcomes influenced by social and epidemiologic determinants of health as important epigenetic changes are or have already taken place. examples of tools that will be used to capture social and epidemiologic data include validated surveys for nutrition, physical activity, sleep, and stress. the importance of these tools is that many of the data points captured are modifiable, and therefore if associations are noted between these data points and health outcomes, actionable interventions may be developed and implemented for women who are preconceptional.

Eligibility criteria:
inclusion criteria: * women ages 18-44 seeking pregnancy at northwestern fertility and reproductive medicine (frm) who agree to 1. be followed for a period for up to 25 years 2. share information regarding their child's health * no prior ivf cycles exclusion criteria: * women using donor oocytes or gestational carriers * inability or unwillingness to provide informed consent for any aspects of the study
a clinical study to evaluate safety, tolerability and pharmacokinetics of sv001 in chinese healthy adult volunteers.

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of this study is to evaluate safety, tolerability, pk and immunogenicity of sv001 compare to placebo in chinese healthy adult volunteers.


Eligibility criteria:
inclusion criteria: 1. subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the informed consent form; 2. subjects must have a body mass index in the range of 19\~26 kg/m2, with males weighted not less than 50 kg, and females weighted not less than 45 kg; 3. subjects must be in good health as judged by the investigator. 4. reliable contraception must be assured during and for some time after the trial. exclusion criteria: 1. subjects with a history of drug or other substance anaphylaxis; 2. subjects with respiratory symptoms or abnormal respiratory tract; 3. subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices; 4. subjects with other diseases or factors with abnormal clinical manifestations; 5. subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period; 6. subjects who smoked more than 5 cigarettes a day in the period before screening; 7. subjects who consumed more than 14 units of alcohol per week in the period prior to screening, or who is positive in breath alcohol test at baseline period; 8. subjects who have suffered a clinically significant severe disease or undergone major surgical operations within a certain period of time prior to receiving the investigational drug, or who are expected to require major operations during the clinical trial; 9. subjects who used other drugs within a certain period of time before receiving the investigational drug; 10. screening period: fev1≤80% predicted value or fvc≤80% predicted value; 11. subjects who have antibody positive for human immunodeficiency virus, hepatitis b surface antigen, hepatitis c or treponema pallidum. 12. subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia; 13. female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period; 14. subjects who have participated in other drug clinical trials and used other drugs in clinical trials within a certain period of time before receiving the investigational drug; 15. subjects who have a history of blood donation or blood loss of more than 400 ml in the period prior to screening; 16. any other status in which the investigator deems inappropriate to participate in the present study.
a study of sintilimab plus ramucirumab as first-line treatment for g/egj adenocarcinoma (orient-106)

Conditions: Gastric Adenocarcinoma

Summary: the main purpose of this study is to evaluate the efficacy and safety of sintilimab plus ramucirumab compared to stand of care first-line chemotherapy in participants with advanced gastric or esophagogastric adenocarcinoma.

this is a randomized, multicenter, phase 3 study to evaluate the efficacy and safety of sintilimab combined with ramucirumab as compared to stand of care chemotherapy for the first-line treatment of pd-l1 positive, unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. the primary endpoint of this study is os of the itt population.

Eligibility criteria:
inclusion criteria * have a histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma * with her2 negative and pd-l1 positive tumor tissue * have fresh or archival tumor tissue samples within 6 months for pd-l1 expression test. * age ≥18 and ≤75 years * diagnosed as unresectable locally advanced or metastatic stage exclusion criteria * have received any prior palliative systemic treatment for advanced gastric or gastroesophageal junction adenocarcinoma. * known to have central nervous system metastases, cancerous meningitis, or bone metastases with a risk of paraplegia * known bone metastasis with a risk of paraplegia. * have any ascites that requires intervention. * with bilateral medium pleural effusion or unilateral large pleural effusion leading to respiratory symptoms
phototoxicity test of dapsone gel in healthy volunteers

Conditions: Healthy Volunteers

Summary: this study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic reaction following irradiation of the skin under controlled conditions.


Eligibility criteria:
inclusion criteria: -healthy adults. exclusion criteria: * skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application * sensitivity to adhesive bandages or tape.
treatment of sudden deafness with prednisone+hyperbaric oxygen and prednisone+somatosensory stimulation

Conditions: Hearing Loss, Sudden; Prednisone Acetate; Hyperbaric Oxygen; Somatic Stimulus

Summary: to study the effective treatment of sudden deafness by giving prednisone, hyperbaric oxygen and somatosensory stimulation to sudden deafness patients.

60 cases of sudden deafness within 2 months of 14-80 years old were randomly divided into two groups. they underwent hearing tests, magnetic resonance imaging of the head, and routine hospital admissions. one group was given prednisone for 1 mg / kg body weight × 7 days + somatosensory stimulation × 30 days, the other group was given prednisone for 1 mg / kg body weight × 7 days + hyperbaric oxygen × 15 days, and repeated electrical audiometry every week. one month and three months after the experiment, repeated audiometry.

Eligibility criteria:
inclusion criteria: * sudden deafness * history within 2 months * age 14-80 exclusion criteria: * neurological diseases (such as brain tumors) * patients with mental / mental illness undergoing treatment * pregnant women and patients with other untreatable diseases * finding the cause of sensorineural deafness * patients not suitable for hyperbaric oxygen * a patient with dermatosis

Keywords: hearing loss, sudden prednisone acetate hyperbaric oxygen somatic stimulus
long-term assessment of rhône réppop care for overweight and obese children.

Conditions: Overweight, Childhood; Pediatric Obesity

Summary: childhood obesity is a major public health issue since it is a risk factor of adulthood obesity, cardiovascular disease, psychological disorders, and other chronic conditions. réppop is a two year personalized pathway for multidisciplinary care for overweight and obese children, close to patients' homes. short and medium-term assessments of rhône réppop care for overweight and obese children show encouraging results. long-term assessment is needed to confirm these results. the present study aims to assess the long-term efficiency of rhône réppop care for overweight and obese children by comparing bmi z-scores at the start and the end of réppop care to the current bmi. this data will be collected through a telephonic questionnaire by the scientific manager. the study's secondary objectives are to evaluate patients and their families' lifestyle changes and to improve réppop practices.


Eligibility criteria:
inclusion criteria: - all overweight and obese children included in réppop care programs from 01/01/07 to 31/12/10 exclusion criteria: * refusal to respond to the telephonic questionnaire * subjects who withdraw their consent to participate in the study * subjects aged under 12 years

Keywords: pediatric obesity overweight, childhood
clinical pharmacokinetics of tkis in chinese patients of hepatitis b (hbv)

Conditions: Non Small Cell Lung Cancer; Hepatitis B

Summary: the study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in chinese patients of non-small-cell lung cancer and hepatitis b. the study is self-controlled. the plasma concentration of tyrosine kinase inhibitors will be analyzed before and after system treatment of hbv.

tyrosine kinase inhibitors (tkis) are first line treatment for non-small-cell lung cancer patients with mutations in targeted genes. tkis are metabolized in liver into inactive metabolites before eliminating from body. liver function might plays a significant role in inter-individual differences of pharmacokinetics of tkis. hepatitis b is a disease of high prevalence in south china. the liver function will be compromised if the infection of hepatitis b virus has not been controlled. this study aims to compare the pharmacokinetics of tkis before and after controlling hbv with standard treatment in chinese patients of non-small-cell lung cancer.

Eligibility criteria:
inclusion criteria: * pathological confirmed non-small-cell lung cancer * with epidermal growth factor receptor (egfr) or anaplastic lymphoma kinase (alk) genetic mutation required by different tkis * liver function, alt and/or ast \<= 2\*upper limit of normal (uln) * diagnosed of chronic hepatitis b * hepatitis b negative as controlled group * receiving one type of tkis * age between 18-70 exclusion criteria: * diagnosed of acute/ active hepatitis b * diagnosed of aids * unable to make decision because of metastasis to central nervous system

Keywords: tyrosine kinase inhibitors pharmacokinetics hepatitis b
non invasive detection of cardiac allograft rejection by circulating micrornas

Conditions: Cardiac Transplantation

Summary: the purpose of this study is to evaluate the level of expression of 4 circulating micrornas in the serum using rt-pcr. a pilote study with cardiac transplant patients has shown that expression of these micrornas could discriminate patients with a histologically proven rejection from patient displaying a normal endomyocardial biopsy. the signature must be confirmed in unselected patients and its stability evaluated according to clinical, biological and immunological parameters of included patients.

heart transplantation is the only available long-term treatment option for patients with terminal heart failure. despite considerable progress in immunosuppressive regimens, allograft rejection remains a major cause of graft loss. majority of cardiac allograft rejection are asymptomatic. only severe rejection goes along with cardiac dysfunction. this clinical latency makes the cardiac rejection diagnostic difficult and has ruled modalities of detection of cardiac rejection. the cornerstone of rejection diagnosis and post-transplant follow-up relies on endomyocardial biopsy (emb) and classical histopathology assessment. echocardiography and mri are neither sensitive nor specific enough to replace emb. majority of transplant centers thus evaluate rejection using iterative protocol biopsies. these cardiac allograft monitoring protocols are heavy, with 15 to 20 emb in the first year of transplantation and 1 to 2 emb each year after the first year. emb are invasive procedure with a low but not zero risk of severe adverse events. repetition of emb is associated with tricuspid regurgitation due to valvular complications. moreover incidence of cardiac rejection explains the cost-effectiveness of embs: 50 to 70% of biopsies are normal. the goal is thus to detect rejection in the blood by measuring expression levels of 4 circulating micrornas in patients' sera by rt-pcr. the seric expression levels of these 4 circulating micrornas will be compared to the histopathological diagnosis made on concomitant endomyocardial biopsy.

Eligibility criteria:
inclusion criteria: * patients with a cardiac transplant at the time of inclusion * patients transplanted for less than 10 years and having an annual follow-up * patients with a biopsy evaluation during their follow-up, at month 1, 3, 6, 12 (newly transplanted) and annually (newly and already transplanted patients) and concomitant routine blood work * patients not opposed to the study * patients with assessment of anti-donor specific antibodies during the study period exclusion criteria: * patients with a multi-organ transplantation
functional assessment screening tablets - patient reported measures

Conditions: Smoking

Summary: the team's ultimate goal is to improve health care quality and effectiveness and support patient-centered care. in this project, we, the investigators, will test whether providing patients with guideline based-recommendations regarding tobacco use, physical activity and mental and physical health-related quality of life (patient reported measures: prms) using health information technology increases doctor-patient discussions regarding these topics and results in improvements in prms. we will randomize physicians in a single general internal medicine practice. patients seeing intervention physicians will receive guideline-based recommendations regarding prms, those seeing control physicians will not. we will compare differences in doctor-patient discussions regarding prms between the intervention and control groups. the successful completion of this project will provide evidence the effectiveness of involving patients in their care through the use guideline-based feedback.


Eligibility criteria:
inclusion criteria: * physicians who see patients in the university of pittsburgh general internal medicine practice. * patients of physician's who have consented to participate. exclusion criteria: * age less than 18.

Keywords: health-related quality of life physical activity
a proof of concept and dose-finding study of xxb750 in patients with heart failure

Conditions: Heart Failure

Summary: this is a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of xxb750 in participants with hfref/hfmref.

eligible participants will be randomized to receive either subcutaneous (s.c.) xxb750 or placebo; or sacubitril/valsartan for 16 weeks, and then followed-up for 8 weeks

Eligibility criteria:
inclusion criteria: * current symptom(s) of hf nyha class ii-iii and lvef \< 50% * elevated nt-probnp levels at screening. * receiving standard of care background hf therapy. exclusion criteria: * current acute decompensated hf or hospitalization for hf within 3 months prior to screening. * current symptomatic hypotension (for example dizziness/presyncope). * k+ \> 5.4 mmol/l at screening * egfr \< 30 ml/min/1.73m2 at screening other protocol-specific criteria may apply.

Keywords: heart failure randomized double-blind dose finding xxb750
dehydration cognition

Conditions: Dehydration

Summary: the investigators want to understand the impact of the body losing and gaining water on brain function. participants will restrict fluids consumed and exercise to lose 5% of body mass. participants will then be provided fluid equal to the volume lost to consume over 2 hours (recovery). a series of brain function tests will be performed at baseline, following weight loss, and following recovery.

a baseline series of brain function tests will be performed. following this, participants will complete a 24 hour fluid and water rich food restriction on the day proceeding testing. participants will then complete moderate to high intensity exercise in a hot/humid room to achieve 5% body mass loss. once baseline core body temperature returns to baseline levels, the series of brain function tests will be performed. participants will then consume a sports drink equal to the volume of sweat lost over the course of a 2 hour recover period. following this, he series of brain function tests will be performed.

Eligibility criteria:
inclusion criteria: * healthy * recreationally active * 18-26 years old exclusion criteria: * history of cardiovascular, metabolic, respiratory, neural, or renal disease * hypertensive (systolic blood pressure ≥ 140 mmhg, diastolic blood pressure ≥ 90 mmhg) or tachycardic (resting heart rate ≥ 100 bpm) during the screening visit * taking medication or supplements with a known side effect of affecting physiological responses to exercise (e.g., aspirin, acetaminophen, beta blockers, statins, stimulants, depressants, ssris) * tobacco or nicotine use in the past six months * current or past musculoskeletal injury impacting physical activity * study physician discretion based on any other medical condition or medication
a study of gw685698x for the treatment of perennial allergic rhinitis in pediatrics

Conditions: Rhinitis, Allergic, Perennial

Summary: the purpose of this study is to assess the effect of an aqueous nasal spray investigational compound gw685698x compared to placebo on the hypothalamic pituitary adrenocortical (hpa) axis system in children 2 to 11 years of age with perennial allergic rhinitis.


Eligibility criteria:
inclusion criteria: * diagnosis and history of perennial allergic rhinitis. * must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours. * must comply with all study procedures and be literate. exclusion criteria: * significant concurrent medical conditions. * certain medications such as corticosteroids and allergy medications.

Keywords: gw685698x perennial allergic rhinitis pediatric intranasal corticosteroid hpa axis function