Kornimate/medical-research-clean huggingface dataset:
microbiome derived metabolism and pharmacokinetics

Conditions: Microbial Colonization

Summary: the investigators will perform single-dose pharmacokinetic (pk) studies in humans following administration of drugs with known microbiome derived metabolism (mdm) in parallel with preclinical studies. by directly comparing laboratory measurements to clinical results, the investigators will be able to confirm the relevance of mdm in vivo, create microbiome-dependent pk profiles of the mdm positive drugs, and establish methodology to capture the contribution of mdm to inter-individual variability in clinical drug pk profiles.

the human gut microbiome has been shown to play an important role in the observed inter-individual variability in therapeutic response, including both efficacy and toxicity. one of the mechanisms by which the gut microbiome exerts these effects is through the direct biochemical transformation of orally administered drugs into more or less active or toxic metabolites, termed herein microbiome-derived drug metabolism (mdm). recent systematic studies have revealed an enormous and largely unexplored biochemical capacity of human gut bacteria - cultured in ex vivo microbial communities or as single isolates - to metabolize dozens of orally administered drugs but the clinical relevance of the observed mdm remains unmapped. this gap in knowledge is a result of overt disconnect between preclinical and clinical studies: mdm studies performed in the laboratory are removed from direct clinical comparisons, and human studies performed during drug development and therapeutic interventions almost completely ignore microbiome contribution. moreover, there is currently a lack standardized experimental methods and mathematical models to start incorporating mdm into clinical decisions. our pk studies are aimed at developing such strategies into clinical practice.

Eligibility criteria:
inclusion criteria: * 18 to 65 years of age * body mass index between 18.5 - 29.9 kg/m2 exclusion criteria * estimated creatinine clearance \< 50 ml/min * liver impairment (liver enzymes \> 2 times upper limit) * antibiotics in the past 3 months * history of gastrointestinal disease * history of autoimmune disorder * chronic viral infection * smoker * alcohol intake (defined as having up to 1 drink per day for women and up to 2 drinks per day for men) * use of immune modulating medications * diabetes mellitus * any history or contraindication to the study medications * additional exclusion criteria will be based on the fda approved prescribing information for selected drugs (i.e., contraindications)
heterosexual hiv transmission study (hats). prospective cohort study

Conditions: HIV Infections

Summary: primary: to identify factors associated with risk of hiv infection through heterosexual activity among urban, inner-city women. secondary: to identify correlates of high-risk behaviors in order to provide a basis for future intervention studies.

at baseline and at 6-month intervals, participants are interviewed about their sexual behavior, drug and alcohol-related behaviors, and recent medical history, and are given a psychosocial assessment. they also undergo a physical exam, including pelvic exam and colposcopy, and have blood and urine specimens collected for hiv testing, drug screening, and std evaluation. additionally, participants are given pre- and post-test counseling and education, including information about social services. they are provided with basic gynecological care and either treatment or referral for medical problems.

Eligibility criteria:
participants must meet the following criteria: * hiv-negative, sexually active women living in social and sexual proximity to men at high risk for acquiring hiv infection. * able to speak english, spanish, or creole. * living in the geographic area surrounding kings county hospital in brooklyn, new york. (hospital-based and community-based recruitment sites will be utilized.) personal history of parenteral drug use by self-report or urine test. heterosexual contact with men at high risk for hiv infection.

Keywords: sex behavior
a study to evaluate camrelizumab plus rivoceranib (apatinib) versus camrelizumab as adjuvant therapy in patients with hepatocellular carcinoma (hcc) at high risk of recurrence after curative resection or ablation

Conditions: Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

Summary: a trial to evaluate the efficacy and safety of camrelizumab plus rivoceranib (apatinib) versus camrelizumab as adjuvant therapy in patients with hepatocellular carcinoma (hcc) at high risk of recurrence after curative resection or ablation.


Eligibility criteria:
inclusion criteria: 1. subjects with a histopathological diagnosis of hcc. 2. subjects who have undergone a curative resection or ablation (radiofrequency ablation \[rfa\] or microwave ablation \[mva\] only). 3. no previous systematic treatment and locoregional therapy for hcc prior to randomization. 4. absence of major macrovascular invasion. 5. no extrahepatic spread. 6. full recovery from curative resection or ablation within 4 weeks prior to randomization. 7. high risk for hcc recurrence after resection or ablation. 8. for patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization. 9. child-pugh class: grade a. 10. ecog-ps score: 0 or 1. 11. subjects with hcv- rna (+) must receive antiviral therapy. 12. adequate organ function. exclusion criteria: 1. known hepatocholangiocarcinoma, sarcomatoid hcc, mixed cell carcinoma and fibrolamellar hcc; other active malignant tumor except hcc within 5 years or simultaneously. 2. evidence of residual lesion, recurrence, and metastasis at randomization. 3. moderate-to-severe ascites with clinical symptoms. 4. history of hepatic encephalopathy. 5. history of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage. 6. active or history of autoimmune disease. 7. interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity. 8. cardiac clinical symptom or cardiovascular disease that is not well controlled. 9. severe infection within 4 weeks prior to the start of study treatment. 10. subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy. 11. thrombosis or thromboembolic event within 6 months prior to the start of study treatment. 12. known genetic or acquired hemorrhage or thrombotic tendency. 13. previous or current presence of metastasis to central nervous system.
the effect of adalimumab (humira) on vascular abnormalities in rheumatoid arthritis. a pilot study.

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine whether anti-inflammatory treatment with adalimumab (humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. markers of endothelial activation are assessed in muscle tissue before treatment and after 3 months, and related to other biomarkers and clinical outcomes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rheumatoid arthritis * fulfillment of the american college of rheumatology 1987 criteria for rheumatoid arthritis * active disease despite treatment with at least one disease modifying anti-rheumatic drug * treatment with adalimumab indicated according to the the patient's rheumatologist * at least six swollen joints in 28-joint index * crp \> 8 mg / l within the last three months exclusion criteria: * treatment with anti-tnf drugs in the last three months * treatment with intravenous corticosteroids within fourteen days * ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion * severe bleeding disorder * extensive or refractory leg ulcers * severe peripheral vascular disease

Keywords: rheumatoid arthritis, cardiovascular disease, adalimumab
duloxetine in the treatment of stress urinary incontinence.

Conditions: Urinary Incontinence, Stress

Summary: the purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.


Eligibility criteria:
inclusion criteria: * women with predominant stress urinary incontinence. * 7 or more incontinence episodes per week. exclusion criteria: * use of monoamine inhibitors.
safety and efficacy of ciclesonide in pediatric patients (6 to 11 years of age) with seasonal allergic rhinitis (by9010/m1-417)

Conditions: Hay Fever; Seasonal Allergic Rhinitis

Summary: the aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. ciclesonide will be administered intranasally at two dose levels once daily. the study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).


Eligibility criteria:
main inclusion criteria: * written informed consent * general good health other than seasonal allergic rhinitis * positive standard skin prick test main exclusion criteria: * pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization * participation in any investigational drug trial within the 30 days preceding the screening visit * a known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation * plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period * plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days or more than 3 days total during the treatment period * use of any prohibited concomitant medications * non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the screening visit * use of antiepileptic drugs for epilepsy within 30 days of the screening visit * study participation by more than one patient from the same household

Keywords: hay fever seasonal allergic rhinitis nasal spray ciclesonide allergic rhinitis
observation of recovery of foveal cone microstructures after macular hole surgery

Conditions: Macular Holes

Summary: the objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (mh) closure is correlated with the best-corrected visual acuity (bcva) is determined.

macular hole patients were evaluated by spectral domain optical coherence tomography (sd-oct) to determine the integrity of the microstructures of the foveal photoreceptors. the inner segment/outer segment (is/os) junction, the external limiting membrane (elm), and the cone outer segment tips (cost) line were determined preoperatively, and at 1, 3, 6, 9, and 12 months after the mh surgery. the correlation between the integrity of the foveal photoreceptor microstructures and the best-corrected visual acuity (bcva) was determined.

Eligibility criteria:
inclusion criteria: * the patients had undergone surgery from march 2008 to august 2009 at kyorin eye center * idiopathic macular hole patients with either a stage 2, 3, or 4 according to the gass classification exclusion criteria: * the presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy * high myopia with an axial length \> 27.0 mm or refractive error \> -8.0 diopters * the patients followed for less than 6 months postoperatively

Keywords: macular hole
prevention of endotracheal tube migration by cuff palpation during robotic surgical procedure

Conditions: Robotic Surgical Procedures

Summary: after intubation, the endotracheal tube was finally fixed after palpating endotracheal cuff at three sites (just below the cricoid cartilage, at suprasternal level and just below suprasternal notch). fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. this distance will be measured repeatedly, after pneumoperitoneum, after trendelenburg position and after making the patient supine at the end of surgery. change in the distance will be noted.

the endotracheal tube (ett) will be placed according to the black mark on the tube, post-intubation, the tube will be finally fixed after palpating endotracheal cuff at three sites (below cricoid cartilage, at suprasternal level and just below suprasternal notch). ett cuff position will be scanned by sonography of airway to confirm the position of the proximal end of the ett cuff. fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. this distance will be measured repeatedly 5 minutes after pneumoperitoneum, 10 minutes after trendelenburg position and 10 minutes after making the patient supine at the end of surgery. change in the distance will be noted to confirm the migration of ett.

Eligibility criteria:
inclusion criteria: * robotic uro-oncological surgical procedures of perineum * robotic gynae-oncological surgical procedures of perineum exclusion criteria: * upper airway fibrosis or tracheal stenosis * large neck swelling distorting or deviating the trachea. * head and neck surgeries * laryngeal and tracheal tumour * tracheal surgery * previous tracheostomy * previous radiation treatment of neck

Keywords: endotracheal intubation pneumoperitoneum trendelenburg position robotic surgery
the study observes afatinib as first-line treatment in patients with epidermal growth factor receptor (egfr) mutation-positive advanced non-small cell lung cancer

Conditions: Non-squamous, Non-Small Cell Lung Cancer

Summary: this study aims to observe the sequential strategy with afatinib as first-line treatment and to find the optimal treatment strategy for long-term chemotherapy-free regimens in chinese patients with egfr-mutated advanced nsclc. furthermore, this study can also assess the effectiveness and safety of afatinib as first-line treatment.


Eligibility criteria:
inclusion criteria: * patients who are diagnosed with locally advanced or metastatic nsclc with egfr sensitive mutation positive * patients who will initiate afatinib as first-line treatment for egfr mutation-positive nsclc * male and female patients with age ≥18 years * written informed consent per local regulatory requirement exclusion criteria: * patients who have received previous systemic therapy (previous adjuvant or neoadjuvant therapies are permitted) * patients with symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication) at the start of afatinib treatment * patients with concurrent participation in an interventional oncology clinical trial during the first-line treatment phase or within the last 30 days prior to the first-line treatment phase. if patients join another interventional study during the period of second-line treatment or later-line treatment, this patient should not be excluded from this study
b/f/taf ease of swallowability trial

Conditions: HIV Infections

Summary: the trial will assess the tolerability and swallowability of a str placebo of b/f/taf as compared to dtg/abc/3tc placebo str in healthy individuals and hiv antiretroviral naïve patients. the study team will evaluate the ease of swallow and patient's tolerance of the medication formulation, an important, yet often overlooked aspect of art adherence, with the potential for significant impact on patient's outcomes.

the study will plan to recruit 50 volunteers who will be randomized to receive placebo a (b/f/taf) or placebo b (dtg/abc/3tc). randomization will ensure that the patients will have equal opportunity to try either placebo tablet first to avoid bias. randomization will be done by an investigator not evaluating or providing the questionnaires to the patient. participants will complete a questionnaire regarding what medications they take and what factors they consider affect their ease to swallow pills or tablets. the participants will be administered one of the placebo tablet with the research investigator present and will complete a questionnaire immediately following the first placebo dose. a study timeout for 15-30 minutes will be done following completion of the questionnaires. after which, participants will take the second placebo tablet and complete the final questionnaires. the primary comparison will be between the placebo tablets a and b for tolerability, ease of swallow and participant preference. the investigators estimate that the sample size needed to detect a difference of at least 1 point in a 5 point likert scale will be 50 patients with a standard deviation of 2 points, with \>90% power.

Eligibility criteria:
inclusion criteria: 1. hiv seronegative or seropositive treatment naïve adult over 18 years of age, currently in stable condition, ambulatory and able to swallow tablets or pills. 2. patients able to provide informed consent and remain in clinic for at least 2 hours. 3. study participants able to complete the study questionnaires. 4. no known history of allergies to any of the placebo components. exclusion criteria: 1. patients with known dysphagia or motility disorders leading to difficulty swallowing liquids, food or medications. 2. patients allergic to any component of the placebo tablets. 3. children under the age of 18 years. 4. adults unable to provide informed consent. 5. female patients known to be pregnant. 6. hiv seropositive patients on antiretroviral therapy or with prior history of antiretroviral therapy.

Keywords: hiv adherence tolerability
botulinum toxin a to treat flexion contracture after total knee arthroplasty

Conditions: Flexion Contracture Following Total Knee Replacement

Summary: the goal of this research project is to evaluate injections of botulinum toxin a (botox) as the treatment for knee flexion contracture after total knee arthroplasty (tka). the current treatment for patients who do not achieve full extension of the knee (flexion contracture) after tka consists of an aggressive physical therapy program, home stretching program, and the use of an extension orthosis (brace). many patients do not tolerate wearing these braces. this initial project is designed to use injections of botox as an adjunct to the standard current treatment and evaluate its efficacy. it is our hypothesis that a single injection into the hamstrings in addition to routine postoperative rehabilitation will result in improved knee extension and this improvement in function should endure without further treatment.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age * subject had a total knee replacement or total knee replacement revision surgery performed at main line hospitals such as bryn mawr hospital, lankenau hospital, and riddle hospital * subject is measured to have at least 10 degree flexion contracture of the operative knee four to six weeks following surgery * subject has the willingness to complete scheduled follow up evaluations as described in the informed consent exclusion criteria: * subject is currently involved in another study or has received investigational product or treatment within the last 30 days * subject is a prisoner * subject is anticipated to be non-compliant * subject is known to be pregnant * subject is mentally incompetent or unable to understand what participation in the study entails * the subject has a known sensitivity or allergic reaction to botulinum toxin a and albumin * the subject is unwilling or unable to give consent or to comply with the follow up program
clinical study with lyrica in patients suffering from epilepsy

Conditions: Neuralgia; Epilepsy

Summary: clinical study with lyrica (pregabalin) in patients suffering from epilepsy. this drug is used as adjunctive therapy with one or more antiepileptics. lyrica has potential to reduce seizure frequency.

- included all adult patients with partial seizures and without contraindications according to summary of product characteristics (smpc).

Eligibility criteria:
inclusion criteria: * adult patients with partial seizures. exclusion criteria: * contraindications according to summary of product characteristics (smpc).

Keywords: lyrica pregabalin epilepsy partial seizures
an observational study of dutasteride and alpha-blocker combination therapy in men with symptomatic benign prostatic hyperplasia and psa level over 4 ng/ml

Conditions: Benign Prostatic Hyperplasia

Summary: to analyze the change in international prostate symptom score (ipss) and serum prostate-specific antigen (psa) level from baseline.

this is a non-interventional, observational and multicenter study. when subjects will be allowed the dutasteride and α-blocker orally once daily for two years by investigator's prescription. they will be invited to this observational study. all eligible subjects can be allowed the prior alpha blockers therapy. details of acute urinary retention (aur) and bph-related prostatic surgery episodes will be recorded at every visit. subjects will return to the clinic for assessment every 3 months until week 96. the efficacy and safety of combining the 5α-reductase inhibitor (5ari), dutasteride, and the α-blocker will be assessed.

Eligibility criteria:
inclusion criteria: * males, age ≧ 50 years * clinical diagnosis of bph by medical history and physical examination, including a digital rectal examination (dre) * ipss score ≧ 8 points and prostate volume ≧ 30 ml * total serum psa ≧ 4.0 ng/ml and ≦ 20 ng/ml at screening * previous trus-guided biopsy have been done with benign findings and with prostate cancer (cap) not detected within the past 6 months. * dutasteride combination therapy will be allowed by investigator's prescription * ability to understand and willingly provide written informed consent exclusion criteria: * history or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (hgpin) * with symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study * use of finasteride within 6 months of screening visit * use of dutasteride within 12 months of screening visit

Keywords: benign prostatic hyperplasia