Kornimate/medical-research-clean huggingface dataset:
evaluation of curcumin's effect on inflammation in hemodialysis patients

Conditions: Hemodialysis Complication; Hemodialysis-Induced Symptom

Summary: programmed ingestion of turmeric has no adverse effects and reduces plasma level of hs-crp, il-6 and tnf-α accompanying with increases albumin levels in hemodialysis patients. turmeric can be considered as an effective anti-inflammatory supplement in hemodialysis patients.

hemodialysis patients over 18 years were recruited after fulfilling the inclusion criteria.seventy-one hemodialysis patients were randomized into two groups: the trial group (n =35 ) and the controls (n =36 ); a randomization numeric table was used for allocation sequence . trial group received turmeric and control group received placebo for 12 weeks. biochemical determinations included levels of serum albumin (alb), potassium (k) ,blood urea nitrogen (bun), serum creatinine (cr), il-6 level, tnf- α , and liver function tests and hs-crp at the start and end of the study were measured.

Eligibility criteria:
inclusion criteria:• males or females undergoing maintenance hemodyalisis, * age ≥18 year * clinically stable and receiving adequate hemodialysis defined by a single pool kt/v≥1.20 or no less than 3 dialysis sessions per week with a total dialysis time ≥12 hour per week for at least 3 month before enrollment, * diabetic patients must be willing to commence insulin therapy if deemed necessary for plasma glucose control. exclusion criteria: * active malignant disease (defined as less than 5 year since receiving a diagnosis of being malignancy-free) * critical illness as defined by the need for respiratory or circulatory support (in an intensive care unit) * active vasculitis * severe congestive heart failure (new york heart association class iv) * severe chronic systemic infectious or inflammatory disease * liver disease (defined as serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of normal) * known or suspected allergy to trial product(s) or related products * treatment with immunosuppressive agents or receipt of any investigational drug within one month preceding screening * recent or current use of anti-inflammatory corticosteroids agents * a scheduled renal transplantation within the trial period
an extension study of gdc-0853 in participants with moderate to severe active systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: this phase ii, multicenter, open-label extension (ole) study will evaluate the long-term safety and efficacy of gdc-0853 in participants with systemic lupus erythematosus (sle) who have completed study ga30044 (nct02908100) up to 48 weeks.


Eligibility criteria:
inclusion criteria: * able to comply with the study protocol, in the investigator's judgment * completion of study ga30044 up to 48 weeks * acceptable safety and tolerability during study ga30044 as determined by the investigator exclusion criteria: * met protocol-defined treatment-stopping criteria during study ga30044 * an adverse event in study ga30044 that required permanent discontinuation of study drug * in the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to sle or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective * any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the medical monitor
a study of nasopharyngeal carcinoma from guangdong

Conditions: Nasopharyngeal Cancer

Summary: this prospective cohort study aims to establish prognostic models, to discover toxicity associated predictors and to validate randomized trials in clinical practice.


Eligibility criteria:
inclusion criteria: * histological confirmed nasopharyngeal carcinoma; * scanned by magnetic resonance imaging from calvaria vertex to clavicles before treatment; * pretreatment epstein-barr virus deoxyribonucleic acid copy number is available; * irradiated with intensity-modulated radiotherapy; exclusion criteria: * finishing anticancer therapy in two or more hospitals; * pregnancy or lactation; * diagnosed with other sort of cancer before or during the treatment.
breast cancer survivors who experience aromatase inhibitor associated musculoskeletal symptoms (aimss)

Conditions: Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Hormone Receptor-Positive Breast Carcinoma

Summary: this study evaluates the effectiveness of a cognitive behavioral multicomponent treatment program in improving pain, mood, and functioning while reducing medication non-adherence in breast cancer patients with aromatase inhibitor associated musculoskeletal symptoms (aimss).

primary objectives: i. to evaluate the effectiveness of a multidisciplinary pain program for aimss, specifically determine the impact of the program on level of pain, functional status, and adherence to prescribed medication. ii. to identify predictors of improvement in pain, functional status, and mood following participation in the program. outline: this is an observational study. patients attend a 2-day treatment program and complete questionnaires on study. patients also have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * patients are 18 years old or more. * a breast cancer survivor ecog =\< 2, stage 0-iii hr+ who is experiencing musculoskeletal symptoms associated with aromatase inhibitors intake * patients must be at least 6 months on aromatase inhibitors and for no more than 7 years exclusion criteria: * breast cancer survivor patients that are not in aromatase inhibitor treatment or have less than 6 months of treatment or more than 7 years of treatment. * asymptomatic patients * patients less than 18 years old * patient that are not being followed as a mayo clinic patient * patients with stage iv breast carcinoma * patients that are hr - * patients that are ecog 3 or more
integrative analysis of tumor microenvironment and optimization of immunotherapy duration in nscl cancer patients

Conditions: Non Small Cell Lung Cancer

Summary: non-comparative multicentric randomized study to assess long-term benefit of pd-1 inhibition in nsclc patients who experienced a response between 6 and 12 months after initiation of ici (immune checkpoint inhibitor pd1/pdl-1 blockade therapy)

two-arm, non-comparative, prospective, multicentric, randomized study for early discontinuation of immune checkpoint inhibitor pd1/pdl-1 blockade therapy in non-small cell lung cancer patients who achieved objective response between 6 and 12 months after treatment onset.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed non-small cell lung carcinoma (squamous or non squamous). 2. locally advanced/unresectable or metastatic disease. 3. for non-squamous histology, tumor with no oncogenic addiction: no activating egfr mutation, no alk or ros1 rearrangement, 4. treatment with ici (immune checkpoint inhibitor pd1/pdl-1 blockade therapy): 1. in first or second-line treatment as per market authorization. for patients in first line, ici alone or ici + chemotherapy, 2. start of ici treatment 6 to 12 months (+/- 2 weeks) before registration. 5. at least one measurable lesion according to the recist v1.1 criteria before ici treatment onset and confirmed by centralized review (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to recist v1.1). at least one site of disease must be uni-dimensionally ≥ 10 mm. 6. patient with objective response according to recist v1.1 criteria at 6 months or more and less than 12 months after ici treatment onset. response must be confirmed by centralized review 7. at least one lesion that can be biopsied for research purpose. 8. age ≥ 18. 9. performance status \< 2. 10. women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. 11. patient with a social security in compliance with the french law (loi jardé). 12. patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 13. voluntarily signed and dated written informed consent prior to any study specific procedure. exclusion criteria: 1. female who is pregnant or breast-feeding. 2. concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. 3. hypersensitivity to one of the active substances or to one of the excipients 4. any contraindication to pursue ici treatment as per investigator judgement. 5. previous enrolment in the present study. 6. individual deprived of liberty or placed under legal guardianship.

Keywords: immune checkpoint inhibition non-small cell lung cancer treatment duration long-term benefit
a bioavailability and safety study of probuphine versus sublingual buprenorphine in patients with opioid dependence

Conditions: Opioid Dependence

Summary: this study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 probuphine (buprenorphine implants).

this is an open-label study intended to evaluate the relative bioavailability of 4 probuphine implants versus 16mg qd sublingual buprenorphine, as determined by plasma bpn auc(0-24), during 24 hours at steady state. this study will also provide open-label safety and tolerability data in patients treated with probuphine.

Eligibility criteria:
inclusion criteria: * voluntarily provide written informed consent prior to the conduct of any study related procedures * male or female, 18-75 years of age * meet the dsm-iv criteria for current opioid dependence * females of childbearing potential and fertile males must use a reliable means of contraception exclusion criteria: * current diagnosis of acquired immune deficiency syndrome (aids) * received treatment for opioid dependence (e.g., methadone, bpn) within the previous 90 days * current diagnosis of chronic pain requiring opioids for treatment * candidates for only short term opioid treatment or opioid detoxification therapy * pregnant or lactating females * previous hypersensitivity or allergy to bpn or eva-containing substances or naloxone * current use of agents metabolized through cytochrome p450 3a4 (cyp 3a4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir) * current history of coagulopathy, and/or anti-coagulant therapy (such as warfarin) * meet the dsm-iv criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives) * current use of benzodiazepines other than physician prescribed use * significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the investigators would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent * concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in study * participated in a clinical study within the previous 8 weeks * previous participation in a probuphine clinical trial * presence of aspartate aminotransferase (ast) levels greater than or equal to 3 x upper limit of normal and/or alanine aminotransferase (alt) levels greater than or equal to 3 x upper limit of normal and/or total bilirubin greater than or equal to 1.5 x upper limit of normal and/or creatinine greater than or equal to 1.5 x upper limit of normal * clinically significant low platelet count with current history of coagulopathy

Keywords: opioid dependence opioid addiction buprenorphine methadone heroin implant opioid withdrawal opioid pain medication suboxone
a phase iiib study evaluating the effect on serum lipids following a switch to atazanavir in hiv infected subjects evidencing virologic suppression on their first pi-based antiretroviral therapy

Conditions: HIV Infections

Summary: the purpose of this clinical research study is to learn if atazanavir is associated with serum ldl cholesterol in hiv-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.


Eligibility criteria:
key inclusion criteria: * must be on current hiv treatment regimen at least 3 to 6 months prior to study (this must be one protease inhibitor, or ritonavir-boosted protease inhibitor, and two nucleoside reverse transcriptase inhibitors) must be subject's first pi ever received * plasma hiv-1 rna level \< 50 c/ml within 3 to 6 months prior to study start * fasting ldl cholesterol \> 130 mg/dl key exclusion criteria: * wocbp who do not use effective barrier contraception for any reason * women who are pregnant or breast feeding * a life expectancy \< 12 months * presence of a newly diagnosed hiv-related oi or any medical condition requiring acute therapy at the time of enrollment * cushing's syndrome * uncontrolled diabetes mellitus, history of diabetic ketoacidosis or hyperosmolar syndrome * untreated hypothyroidism or hyperthyroidism * nephrotic syndrome or significant proteinuria * obstructive liver disease * active alcohol or substance abuse * proven or suspected acute hepatitis in the 30 days prior to study entry * intractable diarrhea (greater than or equal to 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study start * history of acute or chronic pancreatitis * inability to swallow capsules * presence of cardiomyopathy * known history of prolonged qtc interval * any of the following: 1. clinical symptoms potentially related to heart block 2. heart rate \< 40 bpm 3. any of the following ekg abnormalities: i) pause length \> 3 seconds ii) second or third degree av heart block iii) qtc interval \> 450 msec for males iv) qtc interval \> 470 msec for females * fasting serum triglyceride level \> 750 mg/dl * any of the following lab values within 2 weeks of starting study drug: 1. serum creatinine greater to or equal to 1.5 times the upper limit of normal 2. total serum lipase greater than or equal to 1.4 times the upper limit of normal 3. liver transaminases greater than or equal to 3 times the upper limit of normal 4. total serum bilirubin greater than or equal to 1.5 times the upper limit of normal * hypersensitivity to any component of the formulation of study drug * use of any lipid-lowering agent within 4 weeks prior or during study * use of a pi-containing arv regimen prior to entry which is comprised of more than one pi * inclusion of an nnrti in the pi-containing regimen * prisoners or subjects involuntary incarcerated for treatment of psychiatric or physical illness

Keywords: hiv treatment experienced
induction modified tpf followed by concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma

Summary: the purpose of the study is to evaluate the efficacy and safety of induction mtpf chemotherapy followed by concurrent chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck cancer

the prognosis of patients with locally advanced squamous cell carcinoma of the head and neck (lascchn) is poor, therefore continuous research effort is being made in order to improve treatment efficacy. standard treatment consists of concurrent chemoradiotherapy (ccrt) with cisplatin. in spite of many clinical trials and meta-analyses, the improvement of patient outcomes with the use of induction chemotherapy (ic) hasn´t been clearly demonstrated, partially due to the high toxicity of the standard tpf (docetaxel+cisplatin+fluorouracil) regimen used most frequently in this setting. therefore, the aim of this study is to evaluate the outcomes of patients with lascchn treated with a less toxic induction mtpf regimen followed by ccrt. the study will include patients with lascchn who - by the decision of the multidisciplinary team - have been assigned treatment with ic followed by ccrt. after being informed about the study objectives and potential risks, all patients giving written informed consent and meeting all the eligibility criteria will start the treatment. according to the study protocol, participants will receive 4 cycles of induction mtpf regimen repeated every 2 weeks followed by computed tomography (ct) response evaluation. 3-6 weeks after having completed the last cycle of mtpf, patients without disease progression will start ccrt with 2 cycles of cisplatin every 3 weeks. twelve weeks after radiotherapy termination, a pet-ct scan will be performed in order to evaluate the treatment outcome.

Eligibility criteria:
inclusion criteria: * patients with locally advanced squamous cell carcinoma of the head and neck (lascchn): oral cavity, oropharynx, larynx, hypopharynx, and unknown primary * stage ct4 and/or cn2-n3, with no distant metastases (m0). * eastern cooperative oncology group performance status (ecog ps) 0-2 * initial clinical staging evaluated in: 1. ct scan or mri of the neck and ct scan of the chest or 2. fdg18 pet tc exclusion criteria: * patients with p16 positive oropharyngeal carcinoma ct0-t3 n2 m0 (stage ii), unless extranodal tumor extension * contraindications for cisplatin administration: renal insufficiency (egfr \< 55ml/min), hearing loss, peripheral neuropathy * dysphagia g\>2 with no percutaneous gastrostomy * the presence of distant metastasis (m1)

Keywords: head and neck cancer induction chemotherapy modified tpf concurrent chemoradiotherapy
effect of an investigational lozenge (biofresh® 4plus) versus placebo control on oral malodor (intra-oral halitosis)

Conditions: Halitosis

Summary: this study is designed to evaluate the effect of an investigational lozenge with the enzyme polyphenol oxidase and green coffee extract in reducing and controlling intra-oral halitosis following immediate use and daily use of the lozenge over a one-week period.

this randomized, placebo controlled, double-blind, crossover study will use gas chromatography (gc) and oral microbial measurements to evaluate the reduction and control of intra-oral halitosis by an investigational lozenge containing the enzyme polyphenol oxidase and green coffee extract compared to a placebo control lozenge. a one-week washout period will precede the first crossover period and a one-week washout period will be implemented between periods 1 and 2. the study will consist of five study visits: screening visit, period 1 baseline visit, crossover period 1 day 8 visit, period 2 baseline visit, crossover period 2 day 8 visit.

Eligibility criteria:
to be eligible for study participation, subjects must meet the following criteria: inclusion criteria: 1. generally healthy males and females ≥18 years of age. 2. able to read, sign and receive a copy of the signed informed consent form. 3. have an average oralchroma™ reading ≥ 125 ppb hydrogen sulfide (h2s gas), volatile sulfur compound (vsc), based on 2 vsc measurements at screening (visit 1) and baseline (visit each 2 and 4), at least 12 hours after eating or drinking or oral hygiene. 4. difference of the hydrogen sulfide gas readings is ≤ 500 ppb following the two mouth air samples for each vsc measurement for screening (visit 1) and baseline (visits 2 and 4). 5. intra-oral cause of bad breath (non-systemic origin) as determined by health history or exam. 6. have at least 18 natural teeth. 7. agree to abstain from eating, drinking, breath mints, chewing gum, and any oral hygiene for at least 12 hours prior to evaluation of oral malodor at screening, baseline and day 8 visits. 8. agree to avoid drinking alcohol beverages and eating spicy foods, garlic and onions, cabbage, spices, cauliflower, and radishes (sulfur compounds) 48 hours prior to each study visit. 9. agree to refrain from tongue brushing/cleaning for the duration of the study. 10. adequate oral hygiene and no signs of oral neglect. exclusion criteria: subjects presenting with any of the following will not be included in the study: 1. history of allergy or significant adverse effects following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients. 2. history of allergies to ingredients in the test product. 3. self-reported as pregnant or nursing. 4. self-reported serious medical conditions. 5. based on history and clinical exam: advanced and/or untreated periodontitis, frank caries, and mucosal diseases. 6. antibiotic or anti-inflammatory medication within 30 days of screening visit.
follow up of severely malnourished children (fusam)

Conditions: Severe Acute Malnutrition

Summary: the overall objective of the research is to assess the long-term and cost-effectiveness of a combined nutrition psychosocial intervention to a stand-alone nutritional treatment of children with severe acute malnutrition (sam) aged 6 to 24 months in the saptari district of nepal.

in nepal, the majority of sam children are treated with therapeutic food in community/home-based care, and little is known about the long-term sustainability of the nutritional and health benefits of treatment after rehabilitation. the two treatments will be compared in terms of costs of treatment and convened health benefits (child nutritional status and development, cured rate and relapse, maternal mental health, and family care practices) at both short and long-term periods after admission. the proposed complementary psychosocial intervention focuses directly on the key underlying determinants of acute malnutrition within children's early years, such as child care practices and stimulation, parent-child relationships and maternal mental health. it includes the mother/caregiver as patient of psychosocial support, but also empowers her as the key ally in the treatment of the undernourished child. adding a brief psychosocial component to the standard medico-nutritional treatment is expected to pay off in terms of sustainable recovery, health, and development outcomes of children.

Eligibility criteria:
inclusion criteria: * age: 6-23 months * 2 sexes * diagnosis: uncomplicated severe acute malnutrition requiring follow-up outpatient therapeutic feeding unit (otps), supported by action contre la faim in saptari district * weight-for-height (wh) \<-3 standard deviation compared to the who reference and/or muac \<115 mm * and / or nutritional oedema moderate (+ or + +) * and successful test of appetite * and no medical complications * new cases * presence of mother / father or legal guardian aged \> 18 years. * understanding of the consent and information letter * follow-up possible exclusion criteria: * age \ 24 months * moderate acute malnutrition * severe acute malnutrition complicated * weight for height \<-3 standard deviation compared to the who reference and / or muac \<115mm but failure to test appetite or medical complications or severe oedema + + + or kwashiorkor, marasmus (malnutrition with the same criteria, with oedema mild or severe). * relapse or if already registered in the past two months; * any child with developmental anomalies, known chronic illnesses like epilepsy, twins and multiple births, parents not consenting,

Keywords: severe acute malnutrition psychosocial intervention child stimulation cmam nepal