Kornimate/medical-research-clean huggingface dataset:
ingest i pilot study

Conditions: Esophageal Stricture

Summary: ingest i pilot study is a feasibility study for evaluating the safety and efficacy of dcbs.

the study is designed to determine the safety and effectiveness of drug coated balloon (dcb) treatments on esophageal stricture. up to 30 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of us. subjects will be followed up post-treatment to one year and then annually for up to 5 years. the annual follow up after the first year is optional.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 80 years. 2. benign esophageal stricture with diameter less than 10 mm (barium esophagram). 3. dysphagia score of 2 to 4 (ogilvie dysphagia score). 4. recurrent stricture after at least 2 previous balloon/bougie dilation or stricturotomy sessions. 5. stricture total length ≤ 7 cm. tandem or adjacent strictures are allowed if the strictures are caused by the same underlining disease. 6. ability to undergo periodic endoscopic follow-up. 7. voluntary participation and provided written informed consent. exclusion criteria: 1. pregnancy or breastfeeding or plan to get pregnant in next 12 months. 2. contraindication to endoscopy, anesthesia or deep sedation. 3. benign esophageal stricture due to extrinsic esophageal compression. 4. currently required chest radiation therapy. 5. malignant esophageal stricture. 6. stricture total length \> 7 cm or esophageal strictures at multiple locations where the total stricture length exceeds 7 cm 7. dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (iem), hypertensive lower esophageal sphincter, etc. 8. active erosive esophagitis. 9. present esophageal ulceration, perforation, leak, fistula, or varices. 10. concurrent gastric and/or duodenal obstruction. 11. active systemic infection. 12. allergy to paclitaxel or any components of the delivery system. 13. severe coagulation disorders or current use of anticoagulant for comorbidities. 14. chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use. 15. received steroid injections into target stricture in the last 4 weeks 16. intolerant to proton pump inhibitors. 17. life expectancy of less than 12 months. 18. unwilling or unable to comply with the follow-up study requirements. 19. lacking capacity to provide informed consent. 20. concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, recent laparotomy, pharyngeal or cervical deformity, etc. 21. currently participation in another pre-market drug or medical device clinical study.
a study to collect information about hiv-positive pregnant women and their babies

Conditions: HIV Infections; Pregnancy

Summary: the purpose of this study is to collect medical information about hiv-positive pregnant women and their babies who have been (or are being) seen at study sites. this information will be used to help design future research studies for these patients. the population of hiv-positive pregnant women and their babies who are seen at study sites has not been officially examined. in order to design future studies to research the best care for these patients, this study will examine important characteristics and the general number of women in these trials.

the population served at affiliated actg sites has not been officially described. anecdotal evidence, however, has surfaced regarding the characteristics of hiv-infected pregnant women and the current standard of care during pregnancy. this chart abstraction study is designed to define, more accurately, the pertinent characteristics and general numbers of women in these trials. in this medical chart abstraction study, pertinent information is collected on all hiv-infected pregnant women and their infants who receive primary or consultative care at pactg 367 study sites. part a profiles all hiv-infected women who received care or consultation at study sites and who had a pregnancy outcome between january 1, 1998 through july 1, 1998. \[as per amendment 04/12/02: part a is closed to enrollment.\] part b profiles hiv-infected pregnant women who receive primary or consultative care and a pregnancy outcome following july 1, 1998.

Eligibility criteria:
inclusion criteria a patient may be eligible for this study if she: * is an hiv-positive woman. * is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available. * had a baby on or after january 1, 1998.

Keywords: pregnancy anti-hiv agents
raltegravir-based antiretroviral therapy for resistant hiv-1 infection

Conditions: AIDS/HIV PROBLEM

Summary: this study is to evaluate the safety and efficacy of ral-based regimen in treatment-experienced patients with resistant hiv infection

in our study, both efficacy and safety of raltegravir(ral)-based therapy will be assessed. 300 treatment-experienced patients with drug-resistant hiv will be randomized to two arms (2:1). group a (n=200) will be assigned with ral-based regimen (ral+tdf+lpv/r).group b (n=100) will be assigned with current second-line regimen in china (3tc+tdf+lpv/r). both virological and immunological profiles and responses at baseline and at week 4, 8, 12, 24, 36, and 48 will be evaluated. this study will be the first large-scale, multicenter, randomized, prospective ral-based therapy study in china for hiv/aids patients. the result will provide proves for further practical antiviral therapy for china or other resource-limiting countries.

Eligibility criteria:
inclusion criteria: 1. age between 18-65 years 2. hiv seropositive and confirmed by western blot 3. have taken first line antiretroviral therapy for over one year and have any one of the criteria listed below (viral load of all the patients meeting these criteria should be confirmed at pumch laboratory) 1. viral load more than 400 copies/ml 2. viral rebound (confirmed by hiv rna more than 400 copies/ml after virologic suppression) 3. when viral load cannot be monitored, patients experience immunologic failure who meet at least one of the criteria listed below will be enrolled: * cd4 count equal to or lower than baseline level with first-line therapy,on two occasions over three months apart * cd4 count with 50 percentage fall from the on-treatment peak value * persistent cd4 count levels less than 100 cells/μl after over one-year antiretroviral therapy exclusion criteria: * previous use of protease inhibitors * previous use of integrase inhibitors * pregnancy and breastfeeding * poor compliance and drug interaction, * opportunistic infections or malignancy at recruitment; or opportunistic infections within three months but still unstable within 14 days prior to recruitment * hbsag positive * patients with the any of the following test results during screening for inclusion: wbc count\ 1.5 uln, transaminases or alkaline phosphatase \>3 uln, total bilirubin\>2 uln, serum creatinine kinase\>2 uln * ccr\<60 ml/min * current intravenous drug use * severe neuropathy or mental disorder * history of alcohol abuse and unable to withdrawal * severe peptic ulcer
open label extension (ole) study of the safety and clinical utility of ipx203 in parkinson's disease (pd) participants with motor fluctuations

Conditions: Parkinson Disease

Summary: the purpose of this study is to evaluate the long-term safety and clinical utility of ipx203 in the treatment of participants with advanced parkinson's disease (pd) who have motor fluctuations.

this is a 9-month, multicenter open-label safety extension study. participants who have successfully completed study nct03670953 \[a randomized controlled study to compare the safety and efficacy of ipx203 with immediate-release (ir) carbidopa-levodopa (cd-ld) in parkinson's disease patients with motor fluctuations\] may have the opportunity to enroll in this open-label study.

Eligibility criteria:
inclusion criteria: * successfully completed study ipx203-b16-02 * able to provide written informed consent prior to the conduct of any study-specific procedures. * female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit (visit 1). * agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study. exclusion criteria: * intends to use any doses of rytary® or duopa™ during this study. * plans to use an investigational treatment other than ipx203 during the course of this study. * neurosurgical ablation treatment for pd is planned or anticipated during the study period. implantation of a deep brain stimulator (dbs) for the treatment of pd is permitted during this study. * participants who, in the opinion of the clinical investigator, should not participate in the study.

Keywords: motor fluctuations ipx203
virtual reality-based and face-to-face relaxation programs in pregnant women with preeclampsia

Conditions: Pre-Eclampsia; Maternal Health; Relaxation; Virtual Reality; Fetal Monitoring

Summary: preeclampsia, affecting 2-8% of pregnancies globally, is a leading hypertensive disorder in pregnancy. it is clinically characterized by elevated blood pressure (≥140/90 mmhg) after the 20th gestational week, often accompanied by proteinuria and systemic complications such as thrombocytopenia, liver dysfunction, and cerebral symptoms. this condition poses significant risks for both maternal and fetal health, increasing the likelihood of organ damage, preterm birth, and long-term cardiovascular and neurodevelopmental complications. non-pharmacological interventions, including relaxation techniques, have been explored for symptom management. progressive muscle relaxation (pmr) has shown efficacy in reducing stress, anxiety, and blood pressure. recently, virtual reality (vr)-based relaxation techniques have gained attention for enhancing stress relief and improving health outcomes. this study aims to compare the effects of vr-based pmr with in-person pmr on maternal and fetal outcomes in preeclamptic pregnancies.


Eligibility criteria:
inclusion criteria: * hospitalized with a diagnosis of preeclampsia. * gestational age ≥26 weeks. * 18 years or older. * singleton and viable pregnancy. * willing to participate in the study voluntarily. exclusion criteria: * multiple pregnancy. * pregnancy achieved through assisted reproductive technologies. * hearing or vision impairment in the pregnant individual. * fetal distress requiring emergency intervention. * hellp syndrome or eclampsia. * history of vertigo. withdrawal criteria: * cases where live birth does not occur. * participants who voluntarily withdraw from the study. * participants whose general health condition deteriorates during the intervention. * participants experiencing side effects from virtual reality headset use (e.g., dizziness, nausea, headache). * participants who do not practice progressive muscle relaxation at least once a week after the intervention.
ir-guided ablation (irga) combined with stereotactic ablative radiation (sabr) for large lung tumors

Conditions: Recurrent Non-small Cell Lung Cancer

Summary: this phase i trial studies the side effects and best dose of stereotactic body radiation therapy when given together with ablation therapy in treating patients with non-small cell lung cancer or lung metastases. ablation therapy, such as radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. ablation therapy, such as microwave ablation kills tumor cells by heating them to several degrees above normal body temperature. stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. giving ablation therapy together with stereotactic body radiation therapy may kill more tumor cells.

this is a dose-escalation study of stereotactic body radiation therapy. patients undergo stereotactic body radiation therapy once daily (qd) for a total of 5 fractions and then undergo irga (either radiofrequency ablation or microwave ablation) 1 week later. after completion of study treatment, patients are followed up at 4 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Eligibility criteria:
inclusion criteria: * pathological (histologically or cytologically) diagnosis of non-small cell lung cancer (nsclc); or if lung tumor is considered to be metastases (even from primary nsclc), then clinical diagnosis is sufficient * for nsclc: staging workup at initial diagnosis demonstrates t2-t4n0m0, or t2-t4,n1-3,m1; node-positive patients will be allowed on study only if they have m1 disease; clinical diagnosis of m1 disease is sufficient * patient is deemed (a) to be medically inoperable after evaluation by thoracic surgeon based on, but not limited to the following: baseline forced expiratory volume in one second (fev1) \< 40% predicted, post-operative fev1 \< 30% predicted, severely reduced diffusion capacity, baseline hypoxemia/hypercapnia, coronary artery disease, end-organ damage, or (b): patient has refused surgery after thoracic surgery consultation * eastern cooperative oncology group (ecog) performance status 0-2 * nsclc only: pleural effusion, if present, will undergo routine assessment for malignancy; inability to obtain fluid or non-diagnostic cytology will not preclude eligibility * negative serum or urine pregnancy test within 4 weeks prior to registration in women with childbearing potential * able to provide written, informed consent * minimum of 4 weeks from last dose of chemotherapy to start of treatment exclusion criteria: * for nsclc only: prior invasive malignancy (except non-melanoma skin cancer) unless disease-free for a minimum of 2 years, including previous history of lung cancer * prior radiation to the region of current cancer that would result in \> 50% overlap of the old treatment field on the new treatment area based on radiation oncologist evaluation * international normalization ratio (inr) of \> 1.5 * platelets of \< 50,000 /ul * inability to meet maximum point dose constraints

Keywords: metastatic lung cancer nsclc
the influence of fish-oil lipid emulsions on neonatal morbidities

Conditions: Retinopathy of Prematurity; Neonatal Cholestasis

Summary: docosahexaenoic acid (dha) has been shown to be particularly important for fetal and neonatal development. infants born prematurely are at special risk for dha insufficiency. the source of dha after birth for preterm babies who are not fed full enterally, are mostly fat emulsions as the component of total parenteral nutrition solutions which usually do not contain dha. the aim of this study is to investigate if the fish oil emulsion-administered from the first day of life and during parenteral nutrition-prevents infants from cholestasis and retinopathy of prematurity.

during the study period, preterm infants admitted to nicu were included. infants who weighed \<1500 gr and delivered prematurely before the 32nd week of gestation were eligible for the study. infants with major congenital anomalies, congenital infections and inborn metabolic errors were excluded from the study. group 1: fish-oil emulsion (20% smoflipid: soybean oil 60 g/dl, mct 60 g/dl, olive oil 50 g/dl, fish oil 30 g/dl, egg phospholipids 12 g/dl, glycerol 25 g/dl, vitamin e 200 mg α-te/l) group 2: soybean oil emulsion (20% intralipid: soybean oil 200 g/dl, egg phospholipids 12 g/dl, glycerol 22,5 g/dl, vitamin e 57 mg α-te/l).

Eligibility criteria:
inclusion criteria: * infants below 32 gestational age and requiring parenteral nutrition exclusion criteria: * infants with congenital anomalies, infants above 32 gestational age
internet-based stress recovery program forest+ for healthcare workers

Conditions: Stress, Psychological

Summary: the study aims to assess the efficacy of an internet-based stress recovery intervention for healthcare workers receiving therapist support with or without an intervention plan.

the intervention will be delivered as an internet-based stress recovery program for healthcare workers, comprising of six modules: introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. these modules have been chosen after considering themes that could be most useful for healthcare workers under high stress. each module consists of a psychoeducational and an exercise component. an intervention plan will be drawn up with the therapist prior to the start of the program, setting the intensity of engagement and the frequency of reminders. during the program, a therapist provides individual feedback on the completed exercises and can also be available on request. the effect of the intervention will be compared with a control group that will use the program without an intervention plan. the intervention will be delivered in lithuanian.

Eligibility criteria:
inclusion criteria: * licensed healthcare professionals currently working under license; * at least 18 years old; * comprehending lithuanian language; * access to internet. exclusion criteria: * acute psychiatric crisis; * high suicide risk; * interpersonal violence.
melanole, a dietary supplement, for the treatment of gastroesophageal reflux disease

Conditions: GERD

Summary: melanole, a nigella sativa (black seed) extract , is studied for the treatment of gerd. participants, who meet the inclusion criteria, will be divided into two arms. arm 1: subjects who meet criteria for gerd will undergo 24 hour ph monitoring. arm 2: subjects who meet criteria for gerd and who undergo only symptomatic monitoring of gerd on treatment. all participants will be evaluated before and after the administration of the study product.

volunteers were recruited in lebanese american university campuses. those who fit the inclusion criteria were allowed to choose between two arms: invasive or non-invasive procedures. volunteers who chose to enroll in the non-invasive arm were given the study product directly after completing the gerd q questionnaire. a follow-up by phone was done on day 0, 3 , 6 and 11. gerd q questionnaire was repeated on days 11 and 28 along with a satisfaction rating. adverse events were reported on a log sheet. concerning the invasive arm, volunteers were given an appointment at lebanese american university medical center rizk hospital to place the 24h ph-metry, after study product was administered. after 7-10 days, the 24h ph monitoring was done again.

Eligibility criteria:
inclusion criteria: * adult patients with age (18-60) with gerdq score ≥3 exclusion criteria: * patients younger than 18 year or older than 60years * dysphagia, odynophagia, weight loss, palpable mass * nonsteroidal antiinflammatory drug intake (including aspirin) * history of hyperparathyroidism * coronary artery disease or congestive heart failure * history of liver disease * history of renal disease * pregnancy * history of active cancer or chemotherapy * history of intake of any drug known to affect reflux (phenothiazine, anticholinergic, nitrates, calcium channel blockers and proton pump inhibitors) within 14 days of inclusion to the study * prior esophageal or gastric surgeries of any type * allergy to black seeds or lidocaine * any important nasal anatomical anomaly * any use of chronic medications for chronic medical conditions
systemic cross-talk between brain, gut, and peripheral tissues in glucose homeostasis: effects of exercise training

Conditions: Obesity; Insulin Resistance; Type2 Diabetes; Exercise Training

Summary: obesity and insulin resistance are worldwide epidemic and taking a major public health toll. obesity also increases the risk for cognitive impairment which is also an increasing medical, societal, and economic challenge. the ultimate goal of this proposal is to develop a statistical model to assess systemic cross-talk between brain, peripheral tissues, gut microbiota and glucose metabolism. integrated with exercise training intervention the results will be utilized to provide disease risk profiling and personalized predictions of exercise training as a drug free treatment for insulin resistance and type 2 diabetes.


Eligibility criteria:
inclusion criteria: * monozygotic twins * body mass index (bmi) difference ≥ 2 kg/m2 and/or type 2 diabetes * at least one co-twin is overweight (bmi \> 25 kg/m2) exclusion criteria: * bmi \> 60 kg/m2 * body weight \> 170 kg * waist circumference \> 150 cm * mental disorder or poor compliance * eating disorder or excessive use of alcohol * active ulcus disease * diabetes requiring insulin treatment or fasting glucose \> 10 mmol/l * pregnancy * past dose of radiation * claustrophobia * presence of ferromagnetic objects that would make mri contraindicated
effectiveness of photobiomodulation and manual therapy alone or combined in tmd patients

Conditions: Temporomandibular Disorder

Summary: the aim of the present study was to investigate the effect of photobiomodulation (pbm) and manual therapy (mt) isolated or combined in the reduce of pain, the improve of mandibular movements, the psychosocial aspects and the anxiety symptoms of patients with tmd.

temporomandibular disorders (tmd) is a complex and multifactorial disease. therapeutic modalities, as pbm and mt, expected to relief of symptoms, improve of function and reduce the impact of the disease in patient's life. fifty-one tmd patients were randomly allocated to three groups: pbm group (n=18) using 808 nm, 100 milliwatt (mw), 13.3 j ∕cm2, 4 j per point), mt group (n=16) with 21 minutes sessions of mt of the masticatory muscles and tmj and combined therapy group (ct) (n=17) applying the 2 protocol described above. all treatments were done three times a week for four consecutive weeks. evaluations were performed at baseline, during the treatment (days 7, 14, 21, and 28) and follow up (day 60 and day 90). visual analogue scale (vas), research diagnostic criteria (rdc/tmd) axis i and ii, beck anxiety inventory (bai) were used in different moments of evaluation time.

Eligibility criteria:
inclusion criteria: * tmd myogenic and arthrogenic diagnosis based in rdc/tmd axis i analysis * pain in temporomandibular joint (tmj) * limitation in mouth opening. exclusion criteria: * current dental or physical treatment * polyarthritis and other rheumatic diseases * use of anti-inflammatory and muscle relaxant

Keywords: temporomandibular diseases photobiomodulation low level laser treatment manual therapy