Kornimate/medical-research-clean huggingface dataset:
prenatal pilates assisted childbirth preparation training and incontinence

Conditions: Incontinence, Urinary; Training Group, Sensitivity

Summary: a randomized controlled trial was made to determine the effectiveness of prenatal pilates-supported childbirth preparation training on birth outcomes, incontinence during pregnancy, and the postpartum period.

one of the risk factors for the development of stress incontinence in women is pregnancy and childbirth. this problem increases as pregnancy progresses and continues in the postpartum period. it was tested the hypothesis, there is no difference in the development of urinary incontinence in the prenatal and postpartum periods among women who receive pilates-assisted childbirth preparation training and women who were into the usual care.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-35, * being in the 28th-30th week of pregnancy * having a singleton pregnancy * being nulliparous exclusion criteria: * having chronic constipation * having a chronic cough * having a history of any psychiatric condition, multiple sclerosis, spinal cord injury, congenital or acquired anatomical abnormalities of the urogenital tract, bladder malignancy * being overweight and obese * giving birth outside of 37-42 weeks

Keywords: pregnancy pilates urinary incontinence childbirth training
a study of an anti-kir antibody lirilumab in combination with an anti-pd1 antibody nivolumab and nivolumab plus an anti-ctla-4 ipilimumab antibody in patients with advanced solid tumors

Conditions: CANCER,NOS

Summary: to assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (bms-986015) given in combination with nivolumab (bms-936558) and to identify dose limiting toxicities (dlts) and the maximally tolerated dose (mtd) of the combination. in addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (bms-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * during dose escalation, subjects with advanced solid tumors (except for primary cns metastases) that have progressed following at least one standard regimen * during cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens * subjects must have measurable disease * subject must consent to provide previously collected tumor tissue * women and men ≥18 years of age with performance status of 0 or 1 * at least 4 weeks since any previous treatment for cancer exclusion criteria: * active or chronic autoimmune diseases * uncontrolled or significant cardiovascular disease * chronic hepatitis (except for subjects with hepatocellular carcinoma) * active infection * active central nervous system (cns) metastases * human immunodeficiency virus/acquired immunodeficiency syndrome((hiv/aids) * positive test for hepatitis b virus surface antigen or hepatitis c antibody (except for subjects with hepatocellular carcinoma) other protocol defined inclusion/exclusion criteria could apply
management of acute appendicitis at district general hospital

Conditions: Appendicitis Acute; Covid19

Summary: the investigators aim to assess; 1. whether the changes in managing patients during covid has reduced the negative appendicectomy rate? 2. compare the difference in outcomes of conservatively and surgically managed acute appendicitis? 3. whether there uniformity in prescribing postoperative antibiotics with resultant outcomes? 4. whether the incidence of complicated appendicitis has increased?

as acute appendicitis is the most commonly managed emergency presentation for surgeons, the investigators aim to assess whether the changes in managing patients during covid has reduced the negative appendicectomy rate, to compare the difference in outcomes of conservatively and surgically managed acute appendicitis? to assess whether there uniformity in prescribing postoperative antibiotics with resultant outcomes? to assess whether the incidence of complicated appendicitis has increased? this will be a single centre retrospective observational study. all the patients presenting in a\&e department with a diagnosis of acute appendicitis to be included. the only exclusion criteria are the age of participants for less than 5 years. the data will be analysed and calculated using spss version 23.

Eligibility criteria:
inclusion criteria: * all participants reporting in accident and emergency with a diagnosis of acute appendicitis irrespective of age above 5 years, gender and morbidities (this group for conservative management) exclusion criteria: * none

Keywords: acute appendicitis covid-19 pandemic management
zirconia vs titanium implants in deficient ridges

Conditions: Alveolar Bone Loss; Periodontitis

Summary: the aim of this study is to evaluate clinically and radiographically soft tissue around single-implant crowns and peri-implant bone resorption respectively by using zirconia implants or titanium implants in horizontally deficient partially edentulous ridges.

experimental: main treatment group zirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group. active comparator: control group titanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group.

Eligibility criteria:
inclusion criteria: based on the classification of alveolar ridge width given by tolstunov, subjects with * partially edentulous (2/3 teeth missing) * systemically healthy subjects within the age group of 25-44 years * class iii ridges characterized by moderate i.e., 4-6mm of alveolar ridge width will be included. exclusion criteria: * medically compromised patients -. subjects who underwent radiotherapy or chemotherapy and with * habit of smoking, tobacco and alcohol abuse * subjects with active periodontal disease to residual dentition and lack of oral hygiene will be excluded from this study.
palliation: the effect of education on pain

Conditions: Bone Metastases

Summary: rationale: although radiotherapy is an effective palliative treatment for patients with painful bone metastases with over 70% responders, pain intensity is not always sufficiently controlled. recent analyses from the randomized dutch bone metastasis study on 1157 patients show that during weekly follow up, 35% of the patients remain above a pain intensity level of 4 on a numeric rating scale (range 0-10) despite pain medication. according to the who criteria, a pain intensity of 5 or higher prompts treatment. as advised in the cbo guideline 'pijn bij kanker' educating patients can improve patient empowerment and thereby pain control. however, the effect of a nurse-led education of patients undergoing palliative radiotherapy for painful bone metastases has not been investigated yet. objective: this project investigates whether nurse-led pain education in addition to standard care results in better control of pain in patients referred for palliative radiotherapy. study design: a national multicenter phase 3 study (n=450). study population: patients with painful bone metastases referred for short schedule radiotherapy. intervention: patients will be randomized between standard care or standard care with the pain education program, a nurse-led pain education. the pain education program will be provided on the same day the radiotherapeutic treatment will start. the nurse will first assess the knowledge of a patient based on a structured interview. thereafter, lacunas will be taught using the 'pijninstructie programma' (pain education program). in addition, nurses will telephone patients at regular intervals during follow-up to monitor their needs. main study parameters/endpoints: the primary outcome of this randomized multicenter study is a decrement of the number of patients whose worst pain intensity remains above 4 at any time during the 12 weeks of follow up with regard to the control group. the secondary outcome is improvement of quality of life. nature and extent of the burden and risks associated with participation, benefit and group relatedness: all patients will fill out the brief pain inventory, the eortc qlq-c15-pal and the eortc qlq-bm22 at baseline and, thereafter, weekly for 12 weeks after randomization.


Eligibility criteria:
inclusion criteria: * 18 years or older * uncomplicated painful bone metastases * primary malignancy is a solid tumour * pain intensity on a numeric rating scale of 5 or higher * indication for short-term radiotherapy * able to fill out dutch questionnaires * able to follow instructions * informed consent provided exclusion criteria: * hematological malignancy * long-term schedule radiotherapy * life expectancy shorter than three months * karnofsky performance score of 40 or less

Keywords: palliation pain education
metabonomics fingerprinting of multiple trauma

Conditions: Trauma

Summary: the aim of this study is to establish plasma metabonomics fingerprinting atlas for severe multiple trauma patient using 1h nuclear magnetic resonance (nmr) based metabonomics methodology and advanced mathematics tools.

metabonomics is a set of measurements of the dynamic metabolic responses of living systems to stimuli or modifications. this field of study developed from the application of nuclear magnetic resonance (nmr) spectroscopy and mass spectrometry as tools for the study of complex biofluids. metabonomics is one of the emerging fields of systemic biology researches concerned with the high-throughput identification, quantification and characterization of small molecule metabolites. a metabonomics fingerprinting can be defined as the complete complement of all small molecule (\<1500 da) metabolites found in a specific cell, body fluid, organ or organism. severe poly trauma involves complex injuries that consist of multiple pathological mechanisms involving cytotoxic, oxidation stress and immune-endocrine. the complexity of the pathological physiology and biochemistry process are determined not only by the initial mechanical assault, but also by secondary processes including abnormality of inflammation regulation, ischemia, anoxia, free-radical formation, and immune dysfunction that occur over hours and days following the injury. for the clinical perspective, one of the key difficulties is to identify the most at-risk patients who could develop multiple organ failures and consequently death. this study aims to establish the dynamics of nmr-based metabonomics fingerprinting of severe multi-trauma patients in order to provide a possible multiple organs failure (mof) or death event prediction.

Eligibility criteria:
inclusion criteria: * age:18-50 years * poly trauma * injury severity score (iss)\>16 and acute physiology and chronic health evaluation(apache)ii\>10 exclusion criteria: * with comorbidity (diabetes,hyperthyroidism or primary organ dysfunction ) * pregnancy

Keywords: poly trauma metabonomics nmr mof
an efficacy, safety and tolerability study of tmc435 in genotype 1 hepatitis c-infected patients who relapsed after previous therapy

Conditions: Hepatitis C

Summary: the purpose of this study is to investigate the effectiveness and safety of tmc435 compared with placebo in patients who are infected with genotype 1 hepatitis c virus who relapsed after previous interferon-based therapy. patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

this is a randomized, double-blind (neither physician nor patients knows the name of the assigned drug), placebo-controlled study of tmc435 in patients who are infected with genotype 1 hepatitis c virus who relapsed after previous interferon-based therapy. patients in this study will also receive two other drugs for their infection called peginterferon alfa-2a and ribavirin. the purpose of the study is to investigate if tmc435 is superior to placebo in reducing hepatitis c virus to an undetectable level 24 weeks after the end of treatment. for the first 12 weeks, patients will take tmc435 or placebo, plus peginterferon alfa-2a and ribavirin. for the next 12 weeks, patients will take peginterferon alfa-2a and ribavirin only. after that, some patients will continue to take peginterferon alfa-2a and ribavirin for up to 24 additional weeks. other patients will stop taking peginterferon alfa-2a and ribavirin. the study doctor will inform each patient about how to take their study medication and when they should stop taking it. after a patient stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study. the total duration of the study is 78 weeks (including screening). patients will be monitored for safety throughout the study. study assessments at each study visit may include but are not limited to: blood and urine collection for testing, ecg assessments (a measurement of the electrical activity of your heart), patient questionnaires, and physical examinations tmc435 will be taken as an oral capsule of 150 mg once per day. peginterferon (pegasys ®) will be given as an injection of 180 µg once each week. ribavirin (copegus ®) will be taken as a tablet twice each day and the dose will depend on your body weight.

Eligibility criteria:
inclusion criteria: * genotype 1 hepatitis c infection (confirmed at screening) * have previously received peginterferon-based therapy for at least 24 weeks with documented hcv rna at last measurement and relapsed within 1 year of last taking medication * liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis c infection * must agree to use 2 forms of effective contraception throughout study (both males and females) exclusion criteria: * infection with hiv or non-genotype 1 hepatitis c * liver disease not related to hepatitic c infection * hepatic decompensation * significant laboratory abnormalities or other active diseases * pregnant or planning to become pregnant

Keywords: hepatitis c tmc435 hcv hep c genotype 1
digital accessible remote olfactory mediated health assessments for preclinical ad

Conditions: Subjective Cognitive Concerns; Mild Cognitive Impairment; Mild Behavioral Impairment; Healthy Aging

Summary: the goal of this study is to objectively test one's sense of smell, called olfaction, in participants with subjective cognitive concerns (scc), mild cognitive impairment, mild behavioral impairment (mbi), and age-matched controls. the main question it aims to answer is whether the aromha brain health test could serve as a predictive biomarker of neurodegenerative disorders. this understanding will aid in the development of a noninvasive, cost-effective diagnostic tool that reliably and specifically distinguishes disease and normal aging populations. participants will take the approximately 45-minute aromha brain health smell test where they will peel and sniff labels on the physical smell cards and answer questions on the web-based app relating to what they smelled. participants will undergo tests for odor intensity, odor identification, odor discrimination, and episodic olfactory memory, but will not be provided the results of these tests.


Eligibility criteria:
inclusion criteria: * a clinical or research consensus diagnosis of the patient's condition or control status. * individuals that are at least 18 years of age at the time of enrollment. * individuals that are no older than 100 years of age at the time of enrollment. exclusion criteria: * primary pulmonary disease such as severe emphysema or asthma not under good medical control. * current sinusitis, common cold, upper respiratory infection, or nasal polyps. * current or recent (past 6 months) alcohol or substance dependence. a prior history of alcohol or substance abuse will not be grounds for exclusion. * pregnancy. * severe cognitive dysfunction that would preclude completion of the olfactory testing. * an adverse reaction to fragrances (ie. they trigger a severe asthmatic attack or nausea).

Keywords: alzheimer's disease olfactory neurodegeneration mild cognitive impairment mild behavioral impairment subjective cognitive concerns olfactory dysfunction biomarker cognitive assessment
the transparent safety study of the 5 in 1 (dtwp-rhepb-hib) combination vaccine produced by the indian serine institute in children of viet nam healthy from 6 to 12 weeks of age in a 3-dose regimen, the interval between doses is 4 weeks

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B

Summary: the objective of this study is to evaluate safety and tolerability of diphtheria, tetanus, pertussis, hepatitis b and haemophilus influenzae type b conjugate vaccine adsorbed in vietnamese infants aged 6-12 weeks. this is an open label, single group, bridging study.

this will be an open label, single group, bridging study. study subjects will be vaccinated with 3 (three) vaccine doses. the first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval. this study was performed in strict accordance with good clinical practice.

Eligibility criteria:
inclusion criteria: * healthy infants, both sexes, between 6 and 12 weeks of age on the day of screening and enrollment * subject born at full term of pregnancy (greater or equal to 37 weeks) and birth weight ≥2500 grams * weight ≥ 3,300 grams at the time of screeningsubject with good health as determined by the medical history, physical examination and clinical judgment of the investigator * parent / legal representative can understand and be able to comply with the requirements of the protocol * subjects born to mothers who are seronegative to hiv, hbv and hcv through a blood test or maternity record. * parent / legal representative is willing to voluntarily sign the consent form for the participant exclusion criteria: * history of diphtheria, tetanus, pertussis, hepatitis b, or hib infections (confirmed either clinically, serologically or microbiologically) * fever (temperature ≥37.50c) or hypothermia (≤35.50c) or acute illness / infection that requires treatment. * previous vaccination against diphtheria, tetanus, pertussis and haemophilus influenzae type b diseases. * known allergy to any component of the vaccine; * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination. * being treated with anticoagulants or at high risk of bleeding. * a family history of sids (sudden infant death syndrome) * have received any blood products, corticosteroids, cytotoxic drugs, immunosuppressive therapy, radiation therapy in the last 4 weeks. * have participated in another clinical trial within 30 days prior to the study vaccination or may participate in the course of the study. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects. * history of any neurological disorders or seizures
theracurmin vs curcumin bioavailability study

Conditions: Bioavailability

Summary: a randomized, open-label, cross-over, single administration study to compare bioavailability of curcumin in health adults

* randomization, open-label, 3-period, 6-sequence, crossover, single * drug-free inverval : more than 7 days * sampling time : 0,0.5,1,1.5,2,3,4,6,8,12h

Eligibility criteria:
inclusion criteria: 1. healthy adult 19 to 60 years 2. bmi 18.0\~30.0kg/m2 at screening 3. subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements. exclusion criteria 1. a person with clinically significant disease corresponding to cardiovascular, respiratory, liver, kidney, digestive system, blood/tumor system, endocrine system, immune system, neuropsychiatry or who has a history within the last 6 months. 2. a person with a history of gastrointestinal disease or surgery (except for simple cecal surgery or hernia surgery) that may affect the absorption of food for clinical research. 3. persons who have an irritable reaction to foods containing turmeric or other drugs and food. 4. those who took medicines within 7 days before the first intake of food for clinical research. 5. food for clinical research if you have consumed foods containing turmeric (eg, radishes, curry) within 7 days before the first intake of food, or you can't consume until the day of intake of food for the last clinical study. 6. those who have participated in other clinical studies within 90 days prior to the first intake of food for clinical research. 7. women who are pregnant or lactating during screening, or who plan to become pregnant during clinical research. a person who is deemed unsuitable for participating in this clinical study because of other reasons.
bfr after bicep tenodesis

Conditions: Shoulder Pain; Bone Mineral Density; Muscle Strength

Summary: a randomized controlled pilot study evaluating the effect of occlusion training on bone density and function of the upper extremity following a biceps tenodesis.

blood flow restriction training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle strength at low resistance and minimal stress on the nearby joint. early research further indicates that it improves systemic bone mineral density with change in bone turnover markers. this novel resistance training has the potential to improve muscle strength and bone density in individuals who are medically unable to perform high resistance exercises typically required to improve these attributes. our study will examine the effect of occlusion training on bone density and function of the upper extremity following a bicep tenodesis. the primary objective of the intervention is to achieve improved bone density and accelerated recovery of upper extremity function as assessed using measures such as validated questionnaires, functional outcome testing, strength testing, and dual energy x-ray absorptiometry.

Eligibility criteria:
inclusion criteria: * selected to undergo a unilateral bicep tenodesis * males and females age 18-65 * dod beneficiaries * must be able to read and write in english in order to consent exclusion criteria: * contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10. * rehabilitation protocol with prohibited muscle strengthening greater than 6 weeks post-operation. * current metallic implants that contraindicate or significantly affect the sensitivity of dexa scan * current implanted defibrillator or pacemaker * pregnancy - per patient self-report. due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, these patients will not be included in this study. * recent history of deep vein thrombosis within the 12 months or on active treatment with anticoagulants * currently taking medications that are known to affect bone density to include heparin, warfarin, glucocorticoids, medroxyprogesterone acetate, cancer treatment medications, bisphosphonates or other osteoporosis treatment medications, and thyroid hormone. * history of hyperparathyroidism * history of upper quadrant lymph node dissection * patient endorsement of easy bruising * history of an upper extremity amputation * active infection in the operative extremity * cancer (current diagnosis per medical record)

Keywords: bicep tenodesis