Kornimate/medical-research-clean huggingface dataset:
an objective double-blind evaluation of bupropion and citalopram in an individual with friedreich ataxia

Conditions: Friedreich Ataxia

Summary: the purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with friedreich ataxia.

this is a double blind study with a single subject to objectively document the clinical effects of bupropion and citalopram in a single patient with friedreich ataxia (fa), whose disorder symptoms have improved with the use of these medications.

Eligibility criteria:
inclusion criteria: * friedreich ataxia exclusion criteria: * unable to provide informed consent
administration of growth hormone to increase cd4+ count in patients taking anti-hiv drugs

Conditions: HIV Infections

Summary: this study is designed to evaluate the ability of growth hormone (gh, also known as somatropin) to increase cd4+ cell counts in patients taking anti-hiv drugs. the study is targeted toward patients with low levels of hiv who continue to have low cd4+ cell counts.

after initiation of haart, many hiv infected patients have significant improvement in cd4+ levels. however, some patients continue to have low cd4+ counts (\< 350 cells/mm3) despite adequate viral suppression. the purpose of this study is to determine whether administration of gh will increase naïve cd4+ production. further, the study will assess whether an increase in naïve cd4+ production will lead to increases in antigen-specific cd4+ and cd8+ t cells. patients enrolled in this study will be randomized to one of two groups. patients in both groups will continue their present haart regimen for the duration of the study. group a patients will receive daily subcutaneous injections of gh for 48 weeks. group b participants will receive no additional therapy for 24 weeks, and will then receive daily subcutaneous gh injections during weeks 24-28 of the study. both groups will receive immunocyanin (keyhole-limpet hemocyanin) injections at weeks 16 and 20 and hepatitis a vaccination at weeks 40 and 44. at the conclusion of week 48, all patients will discontinue gh therapy while maintaining their haart regimen. patients will then be followed for an additional 24 weeks. patients may be asked to participate in a substudy to measure the size of the thymus in people taking gh. patients in the substudy will have a noncontrast ct scan of the chest before beginning gh therapy and again after 24 weeks of gh therapy.

Eligibility criteria:
inclusion criteria * hiv positive * minimum of 1 year of treatment with haart * cd4+ cell count \<350 cells/mm3 * hiv-1 rna \<400 copies/ml for 6 months prior to study entry * acceptable methods of contraception exclusion criteria * serious medical illness requiring hospitalization within 14 days prior to study entry * pregnant or breast-feeding * taking certain medications * allergy to r-hgh, hepatitis a vaccine, klh, or their formulations, including allergies to shellfish * active drug or alcohol dependence * diabetes or uncontrolled hyperglycemia * uncontrolled hypertension * history of carpal tunnel syndrome * active neoplasm requiring treatment

Keywords: hiv infections cd4 lymphocyte count antiretroviral therapy, highly active growth hormone cell division cd4-positive t-lymphocytes treatment experienced
positron emission tomography and computed tomography in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery. icorg 06-35

Conditions: Lung Cancer; Metastatic Cancer

Summary: rationale: diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy. purpose: this phase ii trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery. this is a clinical study, as the patient will be treated using the pet-ct-gtv: - the pilot study is investigating the technological feasibility - the phase ii study will be a 2-stage phase ii study

pilot study- primary objectives: * prospective evaluation of the technical feasibility of integrating pet-ct fusion in st luke's hospital * rate of pet-ct scan based treatment delivery pilot study- secondary objectives: -comparison of gtv, ptv and oar dvhs between conventional 3-dcrt plan and pet-ct based 3-dcrt plan. phase ii study- primary objective: -the safety of pet-ct scan based radiotherapy, with regard to loco-regional disease control. phase ii study- secondary objectives: -comparison of gtv, ptv and oar dvhs between conventional 3-dcrt plan and pet-ct based 3-dcrt plan.

Eligibility criteria:
inclusion criteria: * histologically proven (biopsy or cytology) nsclc (scc, adenocarcinoma, large cell) * tnm clinical non-operable stage i/ii and non-resectable stage iiia/b without pleural effusion * measurable disease * no other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous * patient suitable for radical 3-dcrt * ecog-performance status ≤ 2 / kps \> or equal to 60 * weight loss \<10% within the 3 months prior to diagnosis * no prior radiotherapy to the thorax * patient is suitable for lung-board immobilisation * no chemotherapy received prior to planning pet-ct scan * age 18 and over * provision of written informed consent exclusion criteria: * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol. * fev1 \< 1

Keywords: adenocarcinoma of the lung large cell lung cancer squamous cell lung cancer malignant pleural effusion stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage ia non-small cell lung cancer stage ib non-small cell lung cancer stage iia non-small cell lung cancer stage iib non-small cell lung cancer
s0000d: effect of vitamin e and/or selenium on colorectal polyps in men enrolled on select trial swog-s0000

Conditions: Colorectal Cancer; Precancerous Condition

Summary: rationale: studying tissue samples in the laboratory from participants receiving treatment on the selenium and vitamin e cancer prevention trial (select) swog-s0000 may help doctors predict a participant's response to treatment and help plan the best treatment. purpose: this phase iii trial is studying the effect of vitamin e and/or selenium on colorectal polyps in men enrolled on select trial swog-s0000.

objectives: primary * to assess the effect of selenium on colorectal adenoma (cra) occurrence. * to assess the effect of selenium on number, location, size, histologic type, and degree of dysplasia of cra. * to assess the effect of selenium on colorectal cancer (crc) incidence. secondary * to assess the effect of vitamin e on cra occurrence. * to assess the effect of vitamin e on crc incidence. tertiary * to explore the effect modification of selenium and vitamin e by aspirin on cra occurrence. * to explore the effect modification of selenium and vitamin e by body mass index. outline: this is a multicenter study. endoscopically obtained tissue samples are reviewed by study pathologists to confirm the presence (or absence) of a colorectal adenoma (cra). if a cra is present, the number, location, size, histology, and degree of dysplasia are documented. the cra is also reviewed to exclude a diagnosis of colorectal cancer. additional data, including aspirin use, height and weight, date of birth, and other demographic and baseline characteristics, is also obtained. participants' medical records are reviewed periodically. participants are followed annually.

Eligibility criteria:
disease characteristics: * enrolled on the selenium and vitamin e cancer prevention trial (select) swog-s0000 * screened by lower endoscopy (i.e., sigmoidoscopy and/or colonoscopy) after randomization on select trial patient characteristics: * willing to sign an applicable medical records release form * willing to allow the release of tissue for central pathology review of resected polyps and endoscopic biopsies prior concurrent therapy: * see disease characteristics

Keywords: colon cancer rectal cancer adenomatous polyp
dissection of the molecular and immunological interaction in patients with hcc of viral and non-viral etiologies

Conditions: Hepatocellular Carcinoma

Summary: this project will clarify the potential interaction between hbv infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.

this study will start with a "training cohort" of the ntuh and ntu cancer center patients, consisting of 4 sub-groups: hbv (+) steatosis (+), hbv (-) steatosis (+), hbv (+) steatosis (-) and hbv (-) steatosis (-). hbv (+) is defined as either: (a) hbsag (+) or (b) hbsag (-) anti-hbc (+) and hbv dna detectable in blood or tumor tissue. steatosis is defined by histology. we will enroll 400 patients who had sufficient tissue for testing in the training cohort. the following studies will be performed: (1) ngs of targeted genes panel using the national health research institutes precision medicine platform; (2) transcriptomic analysis of immune microenvironment using rna-seq and multiplex immunofluorescence staining; (3) lipotoxic genotyping for snps; (4) clinical outcomes of mafld vs. non-mafld. the genetic and immunological features will be further tested by a "validation cohort", from collaborative hospitals. this project will clarify the potential interaction between hbv infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.

Eligibility criteria:
inclusion criteria: 1. adult female or male patients aged ≥20 years. 2. hcc has been histologically confirmed with resection specimen. 3. the surgery should be performed with curative intent after 2015 in the study hospital. 4. availability of serum hbsag and anti-hbc data in the electronic medical record. 5. availability of imaging data performed within 3 months before the surgery in the electronic medical record. (at least one of the following: computed tomography, magnetic resonance imaging, abdominal sonography). 6. informed consent is obtained. willingness to provide the residual operative slides and medical records. exclusion criteria: 1. fibrolamellar hcc, sarcomatoid hcc, or a mixture of cholangiocarcinoma and hcc 2. exclusion of hcv patients (anti-hcv positive) 3. inability to cooperate by providing a complete medical history.

Keywords: hepatocellular carcinoma next-generation sequencing precision medicine
men1611 with cetuximab in metastatic colorectal cancer (c-precise-01)

Conditions: Metastatic Colorectal Cancer

Summary: open-label, dose-confirmation and cohort expansion, multicenter, phase ib/ii study to assess the anti-tumor activity and safety of men1611 in combination with cetuximab for the treatment of participants with phosphatidylinositol 3-kinase, catalytic, alpha polypeptide gene (pik3ca)-mutated metastatic colorectal cancer.

this phase ib/ii study investigated the anti-tumor activity and safety of daily oral doses men1611 in combination with cetuximab in female and male participants affected by pik3ca-mutated, neuroblastoma-kristen-rat sarcoma virus (n-k-ras) wild-type, and braf wild-type metastatic colorectal cancer. men1611 is a potent, selective class i phosphoinositide 3-kinase (pi3k) inhibitor. the maximum tolerated dose of men1611 given as single agent was assessed in a phase i trial in participants with advanced solid tumors. this phase ib/ii started with a dose confirmation part (step 1) to identify the recommended phase 2 dose of men1611 given in combination with cetuximab. the study continued with a cohort expansion (step 2) to explore the anti-tumor activity of the selected men1611 dose level combined with cetuximab with further assessment of safety and tolerability.

Eligibility criteria:
main inclusion criteria: * histological documentation of adenocarcinoma of the colon or rectum. * progression or recurrence following prior irinotecan, oxaliplatin, 5-fluorouracil (5-fu) and anti-epidermal growth factor receptor (egfr) containing regimens for metastatic disease. * best response according to response evaluation criteria in solid tumours (recist) criteria to the last anti-egfr containing regimen of partial response or stable disease for at least 4 months. * measurable disease according to recist criteria. * n-k-ras (exons 2, 3 and 4) and braf wild-type and pik3ca mutated. * eastern cooperative oncology group performance status of 0 or 1. main exclusion criteria: * previous treatment with pi3k inhibitor. * brain metastases, unless treated \>4 weeks before screening visit and only if clinically stable and not receiving corticosteroids. * national cancer institute common terminology criteria for adverse events v5.0 grade ≥2 diarrhea. * history of significant, uncontrolled or active cardiovascular disease. * known active or uncontrolled pulmonary dysfunction. * uncontrolled diabetes mellitus (glycated hemoglobin \>7%) and fasting plasma glucose \>126 milligrams/deciliter. * known history of human immunodeficiency virus infection or active infection with hepatitis c virus or hepatitis b virus. * concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents.

Keywords: metastatic colorectal cancer pi3k inhibitor pik3ca mutated men1611 cetuximab anti-egfr mcrc
study to evaluate the efficacy and safety of hip2101 in patients with acute or chronic gastritis

Conditions: Gastritis

Summary: the purpose of this study is to investigate the safety and clinical efficacy of hip2101 in patients with acute or chronic gastritis.


Eligibility criteria:
inclusion criteria: * 19≤ age ≤ 75 * have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment. * patients understood the consents and purpose of this trial and signed consent form exclusion criteria: * patients who cannot perform endoscopy * active gastric or duodenal ulcer * reflux esophagitis, barrett's esophagus, gastric or esophageal varix * zollinger-ellison syndrome, pyloric obstruction, and esophageal stricture, inflammatory bowel diease, acute pancreatitis * history of gastrointestinal surgery * history of malignancy tumor, especially in the upper gastrointestinal tract * severe liver disorder(at screening day, ast or alt level exceeds 3 times more than normal upper range) * severe renal disorder(at screening day, mdrd egfp ≤ 30 ml/min/1.73m2) or chronic renal disease * bleeding disorder * patients who have taken drugs containing following list within 2 weeks before endoscopy : h2-receptor antagonists, proton pump inhibitors, p-cabs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics * patients who have taken anticoagulants within a week before endoscopy * patients who have taken drugs containing following list after endoscopy : gi tract regulators, salicylates, steroids, , nsaids, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines * history of allergic reaction to the medications used in this study * use of other investigational drugs within 30 days prior to the study * history of alcohol or drug abuse * positive to pregnancy test, nursing mother, intention on pregnancy * considered by investigator as not appropriate to participate in the clinical study with other reason
a phase i, double blind, placebo controlled, first in human, single and multiple ascending oral dose, safety, tolerability and pharmacokinetic study in healthy male and female subjects

Conditions: Parkinson's Disease

Summary: the principal aim of this study is to obtain safety and tolerability data when pxt002331 is administered orally as single and multiple doses to healthy subjects.


Eligibility criteria:
inclusion criteria: 1. subjects will be; 1.1. males or females of non childbearing potential 1.2. for females, non childbearing potential is defined as follows: * permanently sterile following hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or confirmed tubal occlusion (not tubal ligation) * postmenopausal, defined as at least 1 year post cessation of menses (without an alternative medical cause) 1.3. of any ethnic origin 1.4. between 18 and 60 years of age, inclusive 2. subjects will have a 2.1. body mass index (bmi) between 18.0 kg/m2 and 32.0 kg/m2, inclusive 2.2. body weight between 50 kg and 100 kg, inclusive 3. subjects will be in good health, as determined by; 3.1. medical history 3.2. physical examination 3.3. vital signs assessment 3.4. 12 lead ecg and 24 hour holter monitoring 3.5. clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is not acceptable) 4. subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
comparative effectiveness of low extra-corporeal shock wave versus acetylcholine iontophoresis on type2 diabetic neuropathy

Conditions: Diabetic Nephropathy

Summary: in our thesis, we will compare the effectiveness of low-intensity shock wave versus acetylcholine iontophoresis as a possible new therapy for microcirculation changes in type 2 diabetic neuropathy

methods: a group of 80 patients (male and female) diagnosed with type 2 diabetes mellitus, was included in the study. their age ranged from 40-60 years. patients randomly will be divided into two groups: study groups (a) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. and study group (b) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. they were selected from south valley university hospitals. group a received low-intensity extracorporeal shock wave therapy li-eswt (3 hz, 0.09 mj/mm2, 300 pulses), for two sessions per week for six weeks. study group (b) received iontophoresis by acetylcholine current intensity of 3 to 5 ma. check skin every 3-5 minutes for signs of skin irritation with (15) min for three sessions per week for four weeks. nitric oxide level and the electrophysiology (emg) of peripheral nerves and muscles were measured pre and post-treatment.

Eligibility criteria:
inclusion criteria: * patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy. * optimized pharmacological treatment that will be remained unchanged throughout the study. exclusion criteria: * implanted cardiac pacemakers. * patients with known skin allergies. * presence of skin inflammations. * peripheral vascular disease. * patients with unstable angina pectoris. * progressive ventricular dysrhythmia. * intermittent claudication.

Keywords: acetylcholine iontophoresis, shockwave
the compliance and prognosis of nsbb secondary prevention of cirrhosis with gastroesophageal varices bleeding

Conditions: Esophageal Varices Bleeding

Summary: non-selective beta blockers are commonly used drugs for primary prevention and secondary prevention in patients with cirrhotic decompensated esophageal varices bleeding，the basic heart rate, blood pressure and condition of different patients have individual differences.this paper mainly discusses the compliance of patients taking nsbb under different follow-up methods and analyze the factors affecting patient compliance.

esophagogastric variceal hemorrhage is a common complication of decompensated liver cirrhosis and the rate of rebleeding after hemostasis is high.effective secondary prevention reduces the risk of rebleeding.non-selective beta blockers are commonly used drugs for secondary prevention.clinically, there is a great difference in the compliance of patients taking non-selective beta receptor blockers.in this study, the enrolled patients were divided into three groups: the traditional follow-up group (face-to-face interview);non-traditional follow-up (wechat, telephone, etc.);traditional and non-traditional methods of follow-up were combined in the group.the investigators collected the basic data before the patients were enrolled, adjusted the medication dosage according to the patients' condition during the follow-up period, and recorded the treatment during the follow-up period, and analyzed the factors influencing the patients' compliance.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. all cases met the diagnostic criteria for cirrhosis 3. all patients were confirmed to be combined with esophageal and gastric varices through endoscopy or portal vein cta or abdominal ct, and had at least one history of esophageal and gastric varices rupture and bleeding. child-pugh was graded as a/b. 4. all patients had basal heart rate greater than 60 beats/min and systolic pressure greater than 90mmhg. exclusion criteria: 1. patients with liver cancer or other gastrointestinal tumors 2. patients with splenomegaly due to extrahepatic portal hypertension and noncirrhosis 3. patients with basal heart rate less than 55 beats/min or systolic pressure less than 90mmhg 4. there are patients with nsbb contraindications such as severe cardiac insufficiency, cardiogenic shock, sinus bradycardia and morbid sinus syndrome, severe ventricular conduction block, bronchial asthma, etc. 5. patients with other diseases other than liver cirrhosis should take beta blockers (such as coronary heart disease, arrhythmia, etc.). 6. patient data is incomplete, data cannot be collected and counted 7. patients who do not agree with secondary prevention after informing them about the adverse reactions associated with medication

Keywords: esophagogastric variceal hemorrhage cirrhosis secondary prevention non-selective beta blocker compliance
sleep positional trainer for positional sleep apnea after mandibular advancement device (mad) therapy

Conditions: Positional Sleep Apnea; Mandibular Advancement Device

Summary: the investigators will perform a clinical trial comparing mandibular advancement device (mad) therapy with sleep positional trainer (spt) and the combination of mad and spt in patients with positional sleep apnea using mad. patients are invited for 2 consecutive polysomnographies (psgs) in randomized order: one psg with spt, one psg with spt and mad. psgs are performed at the antwerp university hospital.


Eligibility criteria:
inclusion criteria: * patients with supine dependent obstructive sleep apnea (osa) after mandibular advancement device (mad) therapy: apnea hypopnea index (ahi) supine ≥ 2x ahi non supine * 5 \< ahi \< 50/h sleep on polysomnography (psg) with mad in situ * ≥ 20% supine position during psg with the mad in situ * ahi non-supine \< 10/h en ahi supine ≥ 10/h on psg with mad in situ * unchanged body mass index (bmi)(bmi ± 1 kg/m²) at moment of inclusion compared to bmi at baseline psg exclusion criteria: * age \< 18 years