Kornimate/medical-research-clean huggingface dataset:
effect of pasireotide long acting release (lar) on gonadotroph adenomas

Conditions: Gonadotroph Adenomas

Summary: the purpose of this study is to determine if administration of pasireotide lar for one year to three patients with gonadotroph adenomas and elevated serum fsh concentrations will reduce the serum follicle-stimulating hormone (fsh) to normal and reduce the adenoma size.

gonadotroph adenomas are the most common pituitary macroadenomas. currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. the reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas express these receptors. for this study, three subjects who have gonadotroph adenomas, as judged by a macroadenoma of the pituitary and elevated serum fsh concentration, will be treated with a long-acting form of pasireotide once a month for one year. the effect of pasireotide on the size of the adenoma will be determined by mri, and fsh secretion will be judged by the serum concentration.

Eligibility criteria:
inclusion criteria: * gonadotroph adenoma exclusion criteria: * visual impairment attributable to the adenoma * radiation therapy * active gallbladder disease * uncontrolled diabetes

Keywords: pituitary tumor endocrine
opioid versus non-opioid anesthesia for ambulatory surgery in children

Conditions: Effect of Anesthesia in Postoperative Pain; Effect of Anesthesia in Extubation Time; Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit; Effect of Anesthesia in Postoperative Adverse Events; Effect of Anesthesia in Discharge Time From the Hospital

Summary: the investigators intend to study the safety and effectiveness of opioid free anesthesia compared to opioid anesthesia in ambulatory surgery in children, regarding postoperative pain, hemodynamic stability, agitation and discharge times. quality of postanesthetic care was estimated in a 24h follow up.


Eligibility criteria:
inclusion criteria: * children, * american society anesthesia i, ii, * ambulatory surgery exclusion criteria: * allergy to anesthetic and analgesic drugs, * history of neuromuscular, * renal, neurological, hepatic disease, * craniofacial anomalies, * obstructive sleep apnea, * obesity, * cardiopulmonary diseases
black raspberry confection in preventing oral cancer in healthy volunteers

Conditions: Healthy Volunteers

Summary: this clinical trial studies black raspberry confection in preventing oral cancer in healthy volunteers. black raspberry contains ingredients that may prevent or slow the growth of certain cancers.

primary objectives: i. to select an optimal black raspberry confection based on altered gene expression and chemical profiles in healthy individuals exposed to 3 black raspberry-based amorphous functional confections with modulated bioactive release rate at two doses (4 g and 8 g). outline: participants are randomized to 1 of 6 arms after 2 weeks. arm i: participants receive black raspberry (brb) confection 1 fast release orally (po) 4-6 hours apart thrice daily (tid) for 2 weeks. arm ii: participants receive brb confection 2 fast release po 4-6 hours apart tid for 2 weeks. arm iii: participants receive brb confection 1 intermediate release po 4-6 hours apart tid for 2 weeks. arm iv: participants receive brb confection 2 intermediate release po 4-6 hours apart tid for 2 weeks. arm v: participants receive brb confection 1 prolonged release po 4-6 hours apart tid for 2 weeks. arm vi: participants receive brb confection 2 prolonged release po 4-6 hours apart tid for 2 weeks.

Eligibility criteria:
inclusion criteria: * be healthy, free-living adults * be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years) * agree to consume a standardized vitamin/mineral supplement and avoid other nutrition and alternative supplements for the duration of the study * agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study * agree to abstain from mouthwashes exclusion criteria: * have an active metabolic or digestive illness including malabsorptive disorders, renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome * have an active or a recent history of any condition that causes altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias * have a known allergy or food intolerance to ingredients in study products (black raspberries),other berries, wheat, or soy * are strict vegans (no consumption of animal, fish or egg products) * are planning to conceive, or are currently pregnant or lactating * are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/day) * have a history of oral cancer or currently undergoing treatment of oral cancer * in the last month have had any active oral lesions or maladies or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening * have strong gag reflex or problems swallowing that prohibit buccal brushing of the oral cavity * have been on an antibiotic regime lasting for one week in the last 6 months

Keywords: black raspberry chemoprevention oral delivery
the effect of esketamine on patients undergoing tumor surgery

Conditions: Tumor Surgery

Summary: although the acute and chronic postoperative pain of surgical patients has gradually been paid attention to, it has not yet been better resolved.and, the incidence of anxiety and depression in cancer patients is constantly increasing，the new analgesic anesthetic esketamine hydrochloride was launched in china last year，however, in the domestic and foreign literature, there are still few reports of esketamine hydrochloride in postoperative analgesia, and most of them are retrospective and small samples.this study aims to investigate whether esketamine has advantages over traditional opioids in terms of postoperative analgesia, anxiety and depression in cancer patients.


Eligibility criteria:
inclusion criteria: * age ≥18 years old; * patients undergoing elective tumor surgery * use intravenous analgesia pump (pcia) after operation exclusion criteria: * patients with severe infection or respiratory system diseases; * severe arrhythmia, unstable angina or myocardial infarction, heart failure; * patients with severe diseases of liver, kidney, endocrine or immune system; ·patients with fever before operation; * one month before operation patients receiving chemotherapy, radiotherapy or immunotherapy; * drug or alcohol dependence; * mental illness, disturbance of consciousness and communication difficulties or inability to understand the questionnaire or refusal to complete; * long-term use of antidepressant and anxiety drugs; * high intracranial pressure high intraocular pressure
hyperopia detection gck with glow fixation

Conditions: Amblyopia Bilateral; Hyperopia of Both Eyes; Astigmatism Bilateral; Accommodation Disorder

Summary: "gocheck kids" has added to its iphone 7+ smart phone with flash concentrator a non-accommodating glow box fixation target. in pediatric eye patients, the "gck" with glow box is compared to cycloplegic refraction as well as school bus accommodation-relaxing skiascopy, "2win" photoscreener and "retinomax."

patients undergoing comprehensive pediatric eye exam were screened with "gocheck kids" iphone 7+ flash concentrated photoscreener with new, non-accommodating glow fixation target are well as "adaptica 2win" photoscreener and "retinomax" auto refraction all without drops before cycloplegia examination. reason for examination, visual acuity, ocular alignment and degree of amblyopia were specifically noted. refractive amblyopia risk factors utilizing "aapos 2003" and "aapos 2013" uniform guidelines were used to validate each screening method. patients for whom cycloplegia exam yielded at least 0.5 diopters hyperopia were compared to determine the ability of each screening tool to detect hyperopia.

Eligibility criteria:
inclusion criteria: * patients having comprehensive pediatric eye examination exclusion criteria: * patients with only one eye
de-escalation of neoadjuvant chemotherapy regimens with targeted therapy among her2 positive patients

Conditions: HER2-positive Breast Cancer

Summary: neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (her2) positive and triple negative breast cancer, which meets the requirements of tumor ≥ 2cm and/or lymph node positive, and the guidelines recommend neoadjuvant therapy as the first choice. chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for her2 positive breast cancer patients. taxane plus carboplatin (tcb) is the first choice of chemotherapy recommended by major guidelines; as an alternative, single drug taxane (t) is also listed as class i recommendation in the latest csco guidelines, but the level of evidence is slightly insufficient. considering the defects such as large side effects of combined chemotherapy, whether single drug chemotherapy can be used as the first choice for some people under the support of targeted drugs remains to be studied. this project plans to a cohort study, based on the large sample breast disease cohort database established by the breast center of peking university people's hospital, and retrospectively include the patients with clinical stage t2 and above and/or lymph node positive breast cancer who received neoadjuvant therapy (tcbhp or thp) from january 1, 2015 to december 31, 2024. patients of the same type were prospectively included from january 1, 2025 to december 31, 2028. the effectiveness and safety of tcbhp and thp as a neoadjuvant therapy were compared.


Eligibility criteria:
inclusion criteria: * 1) patients with her2 positive breast cancer diagnosed by biopsy in peking university people's hospital; * 2) the clinical stage was stage ii or stage iii (i.e. t2 and above, and/or lymph node positive, without distant organ metastasis); * 3) received treatment in our hospital and had hospitalization records; * 4) has signed and agreed to participate in the pkuph breast disease cohort study. exclusion criteria: * 1) lack of clinical and pathological data (such as imaging data and pathological data); * 2) patients with metastatic breast cancer or bilateral breast cancer; * 3) at the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy; * 4) receiving other regimens besides the established neoadjuvant regimens

Keywords: neoadjuvant chemotherapy de-escalation
tourette discrimination (td) stigma scale

Conditions: Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence; Tic Disorder, Childhood; Tics

Summary: the goal of this qualitative study is to understand the challenges of stigmatization and discrimination in children and young adults with chronic tic disorders (ctd), including tourette syndrome. measuring and understanding how stigma affects those with ctd will help inform future work.

this study will utilize a phased approach, where (1) narrative and thematic content data will be obtained through in-depth qualitative interviews of ctd stakeholders. (2) based on these results, a novel scale will be developed through the delphi method with ctd stakeholders. (3) preliminary analyses of the scale's psychometric properties.

Eligibility criteria:
inclusion criteria: ctd cohort 1. physician-confirmed diagnosis of ctd based on the diagnostic and statistical manual for mental disorders-fifth edition (dsm-v) criteria 2. 8-30 years old. parent/caregivers, supporters, medical providers, advocate cohort (s) 1. involved in the care of a child, youth or young adult with ctd 2. the known person with ctd has had tics for more than a year at the time of screening exclusion criteria: ctd cohort exclusion criteria: 1. non-english speaking 2. diagnosis of intellectual disability 3. diagnosis of psychosis 4. any other condition that, in the principle investigator's opinion, would limit the participant's (or parent's) ability to understand study measures. parent/caregivers, supporters, medical providers, advocate cohort (s) 1) the known person with ctd has an intellectual disability or diagnosis of psychosis

Keywords: stigma
a trial to assess the efficacy and safety of spm 927 in subjects with painful distal diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: this phase 2b trial is being conducted at approximately 60 sites in the us to investigate whether lacosamide (spm 927) at different doses reduces pain in subjects with diabetic neuropathy. approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. to qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point likert scale (0-10 scale) during the 7 day period prior to start of treatment. to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. in addition, safety and tolerability of the different doses of lacosamide will be investigated.


Eligibility criteria:
inclusion criteria: * painful distal diabetic neuropathy exclusion criteria: * must have an average pain intensity of ≥ 4 on an 11-point likert scale

Keywords: painful distal diabetic neuropathy
efficacy of octreotide treatment in patients with primary inoperable thymoma

Conditions: Thymoma

Summary: this study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged \>18 years 2. inoperability of thymic tumor. inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that r0 resection cannot be expected. 3. positive result in sms-szintigraphy, 4. thymomas of all who based histological subtypes (rosai, 1999; travis 2004) at masaoka stage iii based on histological examination of core biopsies or resection specimens. 5. patients with and without thymoma associated paraneoplastic syndrome 6. demonstrated tolerance to a test dose of s.c. octreotide injection at visit 1. exclusion criteria: 1. performance status 0,1, or 2 (ecog) 2. symptomatic cholelithiasis, 3. pretreatment with octreotide (longn acting release) within the 3 months 4. patient has received any other investigational agents within 28 days of first day of study drug dosing 5. patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. existence of any other malignant disease is not allowed 6. grade iii/iv cardiac problems as defined by the new york heart association criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) other protocol-defined inclusion/exclusion criteria apply

Keywords: open label phase ii disease clinical trial octreotide thymoma cancer tumor
clinical characteristics, management patterns and outcomes of type a aortic dissection: a sino-us comparative cohort analysis

Conditions: Aortic Dissection

Summary: this study constructed a retrospective cohort study by retrospectively analyzing the data of all patients with aortic dissection from january 1, 2012 to december 31, 2021 from the cardiovascular disease registration system of jiangsu province in china and the data of similar diseases in recent years from national inpatient sample database in the united states


Eligibility criteria:
inclusion criteria: 1.clinical diagnosis of type a aortic dissection exclusion criteria: 1. age\<18, age unknown, 2. diagnosis of aortic aneurysm, transfer out within 1 day, 3. unknown vital status at discharge; 4. unknown treatment type: cardioplegia, valve or cardiac repair only without aortic repair or two types of treatments on different days

Keywords: aortic dissection china the united states
a study of mdx-1106 to treat patients with hepatitis c infection

Conditions: Hepatitis C

Summary: this study examines the safety, tolerability, and immunogenicity of a single dose of mdx-1106 in patients with active hepatitis c genotype 1 or mixed hepatitis c genotype infection.


Eligibility criteria:
inclusion criteria: * infection with hepatitis c genotype 1 or mixed hepatitis c genotype; * asymptomatic or nearly asymptomatic from hepatitis c; * previous therapy with interferon and ribavirin or peginterferon and ribavirin without an svr or relapsed following an svr;or interferon naive subjects * chronically infected (at least 6 months since diagnosis) hcv-positive subjects; * no evidence of bridging necrosis or cirrhosis; * liver biopsy within the last 2 years exclusion criteria: * acute hepatitis c infection * history of prior malignancy, acquired or inherited immunodeficiency or autoimmune disease either documented or anecdotal;

Keywords: hep c
ibp-9414 for the prevention of necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis

Summary: two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.


Eligibility criteria:
inclusion criteria: 1. gestational age ≤32 weeks 2. birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g. 3. \< 48 hours of age. 4. written informed consent from the patient's legally authorized representative(s). exclusion criteria: 1. participation in an additional interventional clinical trial in which an investigational drug will be administered. 2. infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care). 3. congenital or acquired gastrointestinal pathology. 4. other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
metabolomics of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this is an r01 funded project that focuses on the utility of metabolomics as a biomarker for osa. aims 1 and 3 leverages banked samples previously collected from subjects with and without osa at the university of pennsylvania and university of iceland. aim 2 is a prospective study that will collect serum samples from osa subjects at the university of pennsylvania and the university of iceland.

the primary objective of aim 2 is to conduct a prospective observational study to evaluate the metabolomic changes in response to six months of positive airway pressure (pap) treatment among osa patients. newly diagnosed osa patients (ahi\>5) will undergo additional measurements including: accelerometer x one week (to inform the metabolomics), type 2 home sleep test (to assist with osa subtyping), next morning blood draw, 24-hour diet recall (to inform the metabolomics), questionnaires and pvt.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 30-75 years old 4. in good general health as evidenced by medical history and diagnosed with obstructive sleep apnea (defined as ahi\>5) 5. ability to use accelerometer, perform type 2 sleep test at home and agree to use pap treatment. 6. for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. exclusion criteria: 1. current use of pap treatment or mandibular advancement device or inspire device 2. presence of active cancer treatment or heart failure (ejection fraction \<40%) 3. pregnancy or lactation 4. known allergic reactions to components of the plastic (used in pap mask) 5. febrile illness within 2 weeks of signing consent 6. current drug or alcohol abuse 7. known diagnosis and treatment of diabetes because this will independently alter metabolomic results. 8. previously drawn laboratory hemoglobin a1c above normal range (indicative of diabetes).

Keywords: metabolomics biomarker pap osa subtype personalized medicine
"outcome of varicocelectomy on normal semen in patients complaining of orchialgia

Conditions: Varicocele; Pain; Fertility Issues

Summary: varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. the effect of varicocelectomy on semen analysis is controversial. many articles report favorable outcomes and others do not. most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those studies dont report on postoperative semen. this study will focus on the effect of operation on the semen postoperatively .


Eligibility criteria:
inclusion criteria: 1. primary varicocele 2. patient's age more than 19 years 3. normal semen analysis (according to the who 5th guide to semen parameters where sperm concentration equal 15 million per ml , total sperm number 40 million per ejaculate ,normal morphology 4 % and motility a =25% or a+b = 32% is considered normal. 4. scrotal pain after exclusion of other causes. exclusion criteria: * 1- recurrent varicocele