Kornimate/medical-research-clean huggingface dataset:
an open label trial of tmc114/rtv in hiv-1 infected, treatment-experienced subjects.

Conditions: HIV Infection

Summary: the primary objective of the tmc114-c215 study is to evaluate the safety and tolerability of tmc114/rtv over time. the secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

the study will continue for 144 weeks after study medication has begun. for patients failing treatment, they must have participated in the tmc114-c213 or tmc114-c202 for at least 12 weeks and meet specific virologic failure criteria. it is estimated that approximately 150 patients may meet these criteria. major inclusion and exclusion criteria are listed below. for new patients, they must have been on prior antiretroviral therapy, including more than one nucleoside reverse transcriptase inhibitor (nrti), one non-nucleoside reverse transcriptase inhibitor (nnrti) and a protease inhibitor (pi). at least one primary pi mutation must be present at screening. many of the same centers that are participating in the tmc114-c213 and tmc-114 -c202 studies are also participating in the tmc114-c215 study. all sites have the chance to recruit rollover patients into the tmc114-c215 study and some sites listed had approval to recruit new patients into the study. the recruitment of new patients for the tmc114-c215 trial has been fully enrolled. the tmc114-c202 and tmc114-c213 have completed so no more patients are enrolled in this study. two 300mg/100mg darunavir/ritonavir tablets twice daily for 144 weeks.

Eligibility criteria:
inclusion criteria: * previous participation in the tmc114-c202 or tmc114-c213 trials * significant virologic failure during participation in the above trials * study participation in the treatment phase of the original trial for a total of at least 12 weeks before tmc114-c215 screening * patient agrees to take tmc114/rtv with at least 2 other antiretrovirals (nrtis), with or without t-20, from baseline onwards * patient has given informed consent exclusion criteria: * use of disallowed concomitant therapy * patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels * any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety * patient with laboratory abnormalities at screening as defined by actg grading scheme as listed in the protocol * patient withdrawing consent from tmc114-c202 or tmc114-c213

Keywords: tmc114-c215 ritonavir hiv infections tmc114-c202 tmc114-c213
compare the effect of aliskiren plus valsartan versus angiotensin-converting enzyme inhibitor (acei) plus angiotensin receptor blocker (arb) [ramipril plus telmisartan] on the renin-angiotensin-aldosterone system (raas) in hypertensive patients

Conditions: Hypertension

Summary: this study is designed as a mechanistic study to compare the effect of two different combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and ramipril) on the renin-angiotensin-aldosterone system (raas) in patients with moderate hypertension.


Eligibility criteria:
inclusion criteria: * males or females of non-childbearing potential, 18 to 65 years of age with moderate hypertension * patients who are eligible and able to participate in the study exclusion criteria: * severe hypertension or secondary form of hypertension. * serum potassium \> 5.1 meq/l (mmol/l) * heart failure * any history of hypertensive encephalopathy or cerebrovascular accident; any history of tia, myocardial infarction, coronary bypass surgery or percutaneous coronary intervention * uncontrolled or life-threatening arrythmia other protocol-defined inclusion/exclusion criteria may apply

Keywords: aliskiren, hypertension, renin-angiotensin-aldosterone system
long-term voclosporin treatment in adolescent and pediatric subjects with lupus nephritis

Conditions: Adolescent Lupus Nephritis; Pediatric Lupus Nephritis

Summary: the purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the aur-vcs-2020-03 study (vocal) in adolescent and pediatric subjects with lupus nephritis.

this is a 12 month, prospective, multi-center, long-term, open-label extension study of voclosporin in addition to background standard of care with mycophenolate mofetil (mmf) and oral steroids. subjects completing participation and treatment with study drug (voclosporin/placebo) of the vocal study (aur-vcs-2020-03 ; nct05288855) and meeting all eligibility criteria will receive open-label treatment with voclosporin for approximately 12 months giving a total study treatment duration of 18 months from the start of vocal. all subjects will continue to receive background therapy of mmf and oral corticosteroids starting at the same dose as at completion of the vocal study. when clinically indicated, subjects are permitted to be titrated off oral corticosteroids.

Eligibility criteria:
inclusion criteria: * written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations. * age-appropriate assent or informed consent from subject before any study-specific procedures are performed. * subjects who have completed 24 weeks of treatment with study drug (voclosporin/placebo) in the vocal study. subjects who had a temporary interruption and were able to successfully re-start study drug will be allowed to enroll after medical monitor approval. * in the opinion of the investigator subject requires continued immunosuppressive therapy. * subject is willing to continue to take oral mmf for the duration of the study. exclusion criteria: * currently taking or known need for any of the following medications during the study: * cholestyramine or other drugs that may interfere with enterohepatic recirculation of mmf * calcineurin inhibitors (cnis) (e.g., cyclosporin and tacrolimus) * strong cyp3a4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin) * currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. * a planned kidney transplant within study treatment period. * subjects with any medical condition which in the investigator's judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes

Keywords: voclosporin lupus nephritis calcineurin inhibitors adolescents pediatrics
differential diagnosis and clinical treatment strategies of thyroid nodules.

Conditions: Thyroid Cancer

Summary: to investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.

in previous studies, we have found highly prevalent tert promoter mutations in aggressive thyroid cancers. so we plan to perform further research to investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.

Eligibility criteria:
inclusion criteria: * patient with thyroid nodule exclusion criteria: * coagulant function abnormality * pregnant
extension study for participants of maci00206 study of maci® for the treatment of symptomatic articular cartilage defects of the knee

Conditions: Articular Cartilage Defects

Summary: to examine the 5-year efficacy and safety of maci implant, compared with arthroscopic microfracture, in participants who received study treatment in the summit study for treatment of symptomatic articular cartilage defects of the knee.

this study was an open-label, multicenter extension to the summit study designed to examine the 5-year efficacy and safety of maci compared to arthroscopic microfracture in the treatment of articular cartilage defects of the knee in participants who received study treatment in the summit study. follow-up to 2 years post-study treatment was completed as part of the summit study. follow-up from 3 to 5 years post-study treatment in summit was completed in this extension study. all 144 participants who received study treatment in the summit study were eligible for enrollment into this extension study. participants had until the end of the visit window for the last visit of this extension study (ie, week 260 + 6 weeks) to consent to enter this extension study. efficacy and safety assessments were performed at scheduled visits 3, 4, and 5 years following treatment in summit (ie, at weeks 156, 208, and 260 postarthrotomy for patients treated with maci implant or at weeks 156, 208, and 260 postarthroscopy for patients treated with microfracture).

Eligibility criteria:
randomized and received study treatment (maci or microfracture) in the summit study.

Keywords: cartilage legions symptomatic focal cartilage defects microfracture maci autologous chondrocyte
testing adaptive interventions to improve posttraumatic stress disorder treatment outcomes in federally qualified health centers

Conditions: PTSD

Summary: this trial is being completed to develop a stepped-care talk therapy model for patients with ptsd. specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working. the central hypothesis is that beginning with a low- or medium-intensity ptsd intervention and then titrating intensity based on early indications of response will result in clinically significant ptsd symptom reduction with parsimony of resources.


Eligibility criteria:
inclusion criteria: * receive care at a participating federally qualified health center (fqhc) * have a posttraumatic stress disorder checklist (pcl-5) score greater or equal (≥) to 33 * own a mobile device that can be used for the ptsd coach app * have had psychotropic medication stability for at least 4 weeks exclusion criteria: * severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment) * high risk of suicide (defined as meeting criteria for action step 3 on the participant suicide risk screening form * severe alcohol or substance use disorder (moderate-severe alcohol use disorder on alcohol use disorders identification test (audit) (scores ≥ 15) or high risk on national institute on drug abuse quick screen (scores ≥ 27)) * active psychosis or unmanaged bipolar disorder * unstable housing * current engagement in a trauma-focused behavioral treatment (such as prolonged exposure or cognitive processing therapy). * patients who do not speak english will be excluded for logistical reasons.

Keywords: prolonged exposure for primary care mobile device clinician supported ptsd coach app ptsd symptoms prolonged exposure/pe
glucose response to a formula for patients at risk of hypoglycaemia

Conditions: Postprandial Hypoglycemia

Summary: this study assesses the glycemic responses to several nutritional products.

during a study visit fasted subjects will consume one serving of the reference product or of the test products. venous blood samples will be taken at baseline and at several time-points over a 6-hr period.

Eligibility criteria:
inclusion criteria: 1. healthy individuals, 18 up to and including 50 years of age. 2. willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. 3. willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity 24h prior to each study visit. 4. willing to come to the study visit in the morning after an overnight fast of minimum 10 hours and maximum 14 hours (with water only). exclusion criteria: 1. blood glucose levels ≥ 7.8 mmol/l at screening (not fasted) 2. known history of gastrointestinal disease (e.g., diverticulitis, crohn's disease, coeliac disease etc.), bariatric surgery, aids, hepatitis, a history or presence of clinically important endocrine (including type 1 or type 2 diabetes mellitus), or any condition which might, in the opinion of the principal investigator either: 1) make participation dangerous to the subject (e.g. anaemia) or to others, or 2) affect the results. 3. use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the principal investigator either: 1) make participation dangerous to the subject or to others, or 2) affect the results. 4. use of medications known to influence gastric emptying (including but not limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking drugs, antacids and metoclopramide). 5. use of anti-clotting medications. 6. current tobacco smokers or smokers that quite smoking \< 1 month prior to screening (except for occasional (≤ 3) cigarettes/cigars/pipes per week on average over the past month). 7. self-reported pregnancy or breastfeeding

Keywords: nutritional product glucose response carbohydrate metabolism
single balloon enterosocpy obscure gastrointestinal bleeding bleed

Conditions: Obscure Gastrointestinal Bleeding

Summary: the goal of the present study is to investigate the clinical outcomes of patients with gastrointestinal bleeding originating from the small intestine following diagnostic investigation with single balloon enteroscopy. we hypothesize that single balloon enteroscopy can arrive at a diagnosis and provide therapeutics in a majority of patients with gastrointestinal bleeding originating in the small intestine.

the small intestine has been, until recent years, a black box to gastroenterologists because it is difficult to see and reach. radiological imaging provides little details of small intestinal mucosa. capsule endoscopy, introduced in 2001, enables gastroenterologists to visualize the entire small intestine from within for the first time, but it is only a diagnostic tool. single-balloon enteroscopy (sbe) is a new enteroscopy methods that use an overtube with one balloon or a spiral to help pleat bowel onto the endoscope and allow examination of the distal small bowel. this methods allow for biopsy, hemostasis, and other therapeutic interventions to be performed in the small bowel. early reports have been promising; with 50-70% diagnostic yield for small bowel pathology reported in the literature. however, despite these promising results the impact sbe findings on patient outcomes is not clear.

Eligibility criteria:
inclusion criteria: * patients with obscure gastrointestinal bleeding undergoing sbe at barnes jewish hospital exclusion criteria: * less than 3 months of follow up after sbe * the endoscope could not be advanced into the duodenum will be excluded.

Keywords: push-and-pull enteroscopy single-balloon-enteroscopy
dignity therapy in mcrc to increase peaceful awareness & impact goals of care decision-making

Conditions: Stage IV Colorectal Cancer

Summary: the purpose of this study is to try and improve the way that patients with colon cancer understand and cope with their illness and give them tools for talking with their loved ones and family about their illness.

dignity therapy is a well tolerated structured interview that helps patients reflect on who they are, what is most important to them and what lessons they have learned through life. for patients not receiving chemotherapy, dignity therapy gave patients more hope, more meaning in their life, and helped their families. researchers at northwestern university would like to see if it has the same effect in patients getting chemotherapy. we will also see if the dignity therapy changes patient's understanding of their disease and their medical preferences. all study procedures will take place when participants come for a scheduled doctor's visit or to receive chemotherapy. at the first visit participants will answer a questionnaire taking approximately 15-30 minutes. participants will then have a dignity therapy session approximately 1-2 weeks later. a second dignity therapy session will be scheduled again in another 1-2 weeks. each study dignity therapy session will take approximately an hour. one to two weeks later a repeat questionnaire will be filled out. finally, a third and final questionnaire will be complete 4 weeks later.

Eligibility criteria:
* participants must be currently receiving treatment for stage iv colorectal cancer. * participants must have experience disease progression after their first course of treatment and are being considered for second course of treatment or have already started their second course of treatment. * participants must be 18 years old or older. * all participants must have given signed, informed consent prior to registration on study. * participants must speak english.

Keywords: stage iv colorectal cancer
timing of operation in children with a prenatal diagnosis of choledochal cyst

Conditions: Choledochal Cyst

Summary: in this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.

a choledochal cyst (cdc) is a congenital anomaly of the biliary system, which is more common in the asian population. if a cdc is not diagnosed and treated promptly, it often leads to a series of serious complications, including cholangitis, cyst rupture, cholestatic cirrhosis, and even cholangiocarcinoma. infants with a postnatal diagnosis of cdc often present with symptoms, and to avoid the occurrence of serious complications, operative correction should be performed as soon as possible when their clinical conditions allow. however, in the current era with the improvement of prenatal screening technology, an increasing number of choledochal cysts are diagnosed prenatally in the fetus. in developed countries, as many as 15% of choledochal cysts are found before birth. some of these children receive intervention when they are asymptomatic at an early stage, while some have progressed to cdc-related symptoms before operative correction. the timing of operation for children with a prenatal diagnosis of cdc remains controversial. the investigators previous study showed that it is more advantageous to receive surgical treatment in the asymptomatic period for patients with prenatally diagnosed cdc. in addition, the age at operation (months) appears to be unrelated to intraoperative and postoperative complications, which is distinct from previous studies. more interestingly, the investigators found that a specific cyst size (length \> 5.2 cm and width \> 4.1 cm) suggested that clinical symptoms might appear and that the surgery should be performed as soon as clinically safe to proceed. therefore, in this study, the investigators tried to select the operation time according to the cyst size and evaluate the treatment effect.

Eligibility criteria:
inclusion criteria: 1. infants with a prenatal and postnatal diagnosis with cdc 2. prenatal and postnatal hepatobiliary ultrasound data were complete 3. age of visit \< 3 months exclusion criteria: unable to tolerate surgery after birth
a study of gene polymorphisms associated with specific presentations of sexual addiction

Conditions: Sexual Addiction

Summary: the study is intended to identify gene polymorphisms significantly associated with specific behavioral- and preoccupation-typologies of sexual addiction, and to identify additional potential genetic markers of sexual addiction. research subjects with sexual addiction will be identified from the out-patient and in-patient populations of the investigative sites. research subjects in the control group will be identified from the general population and from the student body of selected colleges. approximately 1100 subjects will be enrolled in the study. anticipating 10% drop-out, this is intended to generate a population of approximately 500 men and women clinically diagnosed with sexual addiction, and approximately 500 healthy men and women who do not meet diagnostic criteria for sexual addiction nor have psychopathology who will serve as the control population.


Eligibility criteria:
inclusion criteria: * sexual addict group age \>= 18 years participating in sexual addiction treatment program sexual addiction screening test--revised (sast-r) score \>= 11 meets at least 3 diagnostic criteria for sexual addiction * control group age \>= 18 years sast-r score \< 6 exclusion criteria: * sexual addiction group serious mental illness significant cognitive impairment * control group history of addiction current or previous diagnostic and statistical manual (dsm-5) diagnosis serious mental illness significant cognitive impairment

Keywords: sexual addiction genomics personality polymorphism
anti reflux mucosal ablation therapy in ppi dependent gerd

Conditions: Gastroesophageal Reflux

Summary: this is a prospective, randomized, single-blinded, interventional, controlled trial to evaluate the efficacy and safety of endoscopic anti reflux mucosal ablation (arma) in ppi dependent gastroesophageal reflux disease (gerd) in comparison to controls with a sham procedure.

patients who fulfill the inclusion criteria and, after informed consent, are willing to participate in this study will be prepared for arma. after sedation the patients will be randomized equally into an intervention and control group. the patients are blinded to the procedure. the patients in the intervention group receive arma using argon plasma coagulation (apc) at the gastroesophageal junction (egj) in two semicircular patterns while the control group receives a sham procedure. the approximate duration of the procedure is 30min. after the procedure the patients receive follow up controls at 2, 4, 6 and 12 months. during the first follow up, 2 months after the procedure symptoms are evaluated by questionnaires (gerd- hrql, fssg, vag). subsequently the ppi- medication is stopped in all patients until the end of the study or worsening of symptoms. during the second follow up 4 months after the initial procedure the symptoms are reevaluated by questionnaires. the patients are then unblinded and are told if they received arma or sham procedure. those patients who received arma are examined by esophagogastroduodenoscopy, esophageal manometry and ph metry. further assessments is performed by questionnaires 6 and 12 months after the initial procedure. those patients in the control group are allowed to take part in a crossover to receive the arma procedure as well. if they receive arma, symptoms are reevaluated 2 months after the procedure by questionnaires, esophagogastroduodenoscopy, esophageal manometry and ph metry. further controls are performed after 4, 6 and 12 months by questionnaires.

Eligibility criteria:
inclusion criteria: * ppi dependent gerd for at least 6 months * pathological esophageal acid exposure, defined by demeester score \>14.7 or acid exposure time (aet) \>4.2% in ph metry while off ppi * exclusion of primary esophageal motility disorders by manometry * upper endoscopy with biopsy (exclusion of eosinophilic esophagitis) exclusion criteria: * sliding hiatal hernia \>3cm * los angeles grade c/d esophagitis * primary esophageal motility disorders * grade iv hill´s flap valve * pregnancy or planed pregnancy in the next 12 months * eosinophilic esophagitis * paraesophageal hernia * previous esophageal or gastric surgery * barretts esophagus * liver cirrhosis * varices * lack of consent * asa physical status \>iii

Keywords: anti reflux mucosal ablation arma