Kornimate/medical-research-clean huggingface dataset:
a phase 3, long-term safety and tolerability study of alks 3831 in adults with schizophrenia

Conditions: Schizophrenia

Summary: the primary objective of this study is to evaluate the long-term safety and tolerability of alks 3831 in subjects with schizophrenia.


Eligibility criteria:
inclusion criteria: * agrees to use an acceptable method of contraception for the duration of the study * subject has completed the 24-week treatment period in the antecedent study, alk3831-a303, within 7 days * additional criteria may apply exclusion criteria: * subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine * subject has a positive test for drugs of abuse at study entry * subject is pregnant, planning to become pregnant, or breastfeeding during the study * additional criteria may apply

Keywords: alkermes alks 3831 samidorphan schizophrenia safety
skeletonised versus pedicled internal thoracic artery

Conditions: Heart Diseases

Summary: it is to date unknown whether thunderbeat has a place in harvesting the left internal mammary artery (lima) and whether skeletonisation is superior to pedicle harvested lima. though, some studies have shown improved flow-rates in the skeletonised graft while others shows compromised blood flow to the thoracic wall after pedicle harvested lima. the purpose of this study is to improve the quality of life for patients undergoing coronary artery bypass graft (cabg) operations. the aim of this study is to compare three groups of lima harvesting techniques: pedicled, surgical skeletonised and skeletonised with thunderbeat to determine the best way to harvest lima during cabg operations. the study design is an experimental randomized controlled trial in a single centre. study population: adult patients enlisted for elective stand-alone cabg surgery at the department of cardiothoracic surgery, odense university hospital. study unit: test-days within subject and subject the study will address two main hypotheses in cabg patients: 1. that both the surgical skeletonised and thunderbeat skeletonised harvesting techniques of lima are superior to pedicled harvesting in regards to flowrates and pulsatility index (pi). 2. skeletonized harvesting of lima graft compared to pedicled harvesting improves patient quality of life three days, 30 days, and six months postoperatively.


Eligibility criteria:
inclusion criteria: * stand-alone cabg (surgical removal of the left atrial appendage (laax) is accepted, since it doesn't affect the graft area) * on-pump with cardioplegia (otherwise one cannot be sure of the pressure and perfusion during surgery of the graft) * patients aged \>18 * elective surgery (there is a known higher risk of postoperative complications with urgent surgery) exclusion criteria: * cabg combined with other heart surgery, except from laax * previous heart surgery * lvef \< 40% (there is a known higher risk of postoperative complications with low lvef) * known cancers (there is a known higher risk of postoperative complication) * thoracic radiation therapy (there is a known higher risk of postoperative complication) * severe chronic obstructive pulmonary disease (copd) (there is a known higher risk of postoperative complication) * patients not able to understand written consent * urgent and emergent surgery (there is a known higher risk of postoperative complication)

Keywords: coronary artery diseases left internal mammary artery lima harvesting flow quality of life
a single-arm exploratory study of neoadjuvant therapy

Conditions: Lung Adenocarcinoma

Summary: neoadjuvant egfr tki therapy targeting egfr mutation has some problems failure to fulfill clinical requirements such as low mpr rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.this study hypothesized that tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage ii-iiia non-squamous nsclc with egfr-mutant pd-l1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.in this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage ii-iiia non-squamous non-small cell lung cancer with egfr mutation and expression of pd-l1.


Eligibility criteria:
inclusion criteria: 1. volunteer to participate in clinical research;fully understand and be informed of the study and sign the informed consent form (icf);willing to follow and able to complete all test procedures; 2. age 18-75 (boundary value included), no gender limitation; 3. histologically proven stage ii-iiib lung adenocarcinoma (as defined by the american joint commission on cancer, 8th edition); 4. egfr gene mutation positive (can be tested by tissue or blood samples); 5. pd-l1 ≥ 1% 6. ecog ps score 0-1 (including boundary value); 7. cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed; 8. meet the conditions for receiving platinum containing two-drug chemotherapy; 9. the expected survival time is ≥3 months, and feasible surgery is planned; exclusion criteria: 1. any previous treatment for current lung cancer, including systemic therapy or radiotherapy; 2. there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage iv). 3. a history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.patients with any severe and/or uncontrolled disease or symptom

Keywords: resectable ii-iiib egfr mutation and pd-l1≥1% nsclc neoadjuvant immunotherapy
novel markers of disease progression in interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: study design: a prospective cohort study with a longitudinal design, with several parameters measured serially at baseline and at pre-specified time points during three to five years of clinical observation. primary objective: to validate quantitative analysis of lung sounds as a marker of disease progression in a cohort of patients with interstitial lung disease (ild) via correlation with the extent of fibrosis on hrct, measured both via visual scoring and quantitative ct assessment, and other validated parameters of disease progression such as fvc, tolerance to exercise and patient-related outcomes (symptoms and quality of life). secondary objectives: to determine the prognostic value of quantitative analysis of lung sounds and a series of novel putative biological markers, obtained from peripheral blood and bronchoalveolar lavage, toward poor outcomes (death, categorical decline of % predicted fvc \>10%, acute exacerbation or respiratory-related hospitalisations) as compared to more conventional clinical, physiology and radiologic measurements.


Eligibility criteria:
inclusion criteria: * diagnosis of ild, made according to international guidelines where available * age between 40 and 90 years exclusion criteria: * significant comorbidities or physical impairment that could affect participation
safety and effectiveness of the opira aiol in comparison to commercial iols in patients undergoing cataract surgery

Conditions: Cataract

Summary: this is a clinical trial comparing an investigative accommodative iol and two commercial iols in patients with cataracts undergoing primary cataract surgery.

this is a prospective, multicenter clinical study comparing the safety and performance of the opira accommodative iol, a commercial monofocal iol, and a commercial multifocal iol. eligible patients with bilateral cataracts will undergo cataract surgery implanting one of three study lenses, and will be followed postoperatively for 24 months

Eligibility criteria:
inclusion criteria: * male and female subjects aged 50-75 with bilateral cataracts, good potential vision, and clear intraocular media other than lens opacity exclusion criteria: * comorbidities affecting visual acuity, iop \> 22mmhg, congential cataract
gastrointestinal transit time in patients with guillain-barré syndrome

Conditions: Guillain-Barre Syndrome; Constipation

Summary: constipation is a common condition among patients with guillain-barré syndrome. it is believed, that the constipation is caused by autonomic neuropathy. however, the severity of the constipation, and its relation to autonomic function have not previously been studied.


Eligibility criteria:
inclusion criteria: * guillain-barré syndrome * ability to swallow the capsules used to assess gitt * ability to give meaningful informed consent to participate in the study exclusion criteria: * major abdominal disorders * severe acute comorbidity * known cancer * pregnancy * other known neurological disorder * use of laxatives one week before inclusion. (patients will be excluded if medication with laxatives is started during the one week gitt measurement)
cognitive adaptations to reduce emotional stress associated with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to evaluate a new intervention (cares: cognitive adaptations to reduce emotional stress associated with type 1 diabetes) designed to reduce caregiver depressive symptoms in families of children with t1d. this is a pilot in which all enrolled parents/caregivers will be placed in the intervention group to assess initial pre- to post-treatment impact of the intervention on parent/caregiver depression, distress, and diabetes-related outcomes (e.g., glycemic control).


Eligibility criteria:
inclusion criteria: * parent/primary caregiver of a child diagnosed with t1d between 5-12 years old * parent/caregiver elevated depression symptoms on the cesd-r (score ≥ 16 at time of screening) * child with t1d receiving intensive insulin regimen by multiple dose injections (mdi) or continuous subcutaneous insulin infusion (pump) exclusion criteria: * child with t1d currently in foster care or not living with legal guardian * child with evidence of type 2 diabetes or monogenic diabetes * child with a co-morbid chronic illness (e.g., renal disease) that requires ongoing care beyond t1d * children who are chronically using medications that may impact glycemic control (i.e., systemic steroids) * parents/caregivers who do not speak english (currently there is no way to recruit non-english speaking families because the study questionnaires are only available in english)
evaluate the safety, tolerability, and antiviral activity of gls4 with ritonavir in patients with chronic hbv infection

Conditions: Chronic HBV Infection

Summary: the experiment is divided into two parts: part 1 and part 2.part 1 was the initial treatment patient and part 2 was the treated patient.

about 125 subjects were planned to be included and assigned to the experimental group and the control group according to 4:1.at the same time, a liver biopsy group was set up in each part of the population to receive liver biopsy during the screening period and 48 weeks after completion of drug administration, which was used to detect hbv dna, cccdna, hbsag, and evaluate the degree of liver inflammation and fibrosis.

Eligibility criteria:
inclusion criteria: * chronic hbv infection population * hbeag positive * hbsag≥250 iu/ml * no cirrhosis exclusion criteria: * ast\>5×uln * platelet count less than 90e+09/l * tbil\>1.5×uln * albumin\<35 g/l * inr\>1.5 * afp\>50 ng/ml

Keywords: chronic hbeag positive hbv infection
a prospective,observational follow-up study of nucleoside treated patients with chronic hepatitis b (ocean study)

Conditions: Hepatitis B, Chronic

Summary: this is a prospective, multicentre observational follow-up study of pegifn treatment unstained response in nucleoside experienced patients with chronic hepatitis b.patients will join this study after finished following clinical trail about a study of combination or sequential treatment with pegasys (peginterferon alfa-2a) and entecavir in patients with hbeag positive chronic hepatitis b(osst trail),a real-world study of pegylated interferon in nucleoside-treated patients with chronic hepatitis b (cost study), combination therapy with interferon plus interleukin 2 and hepatitis b vaccine in chronic hepatitis b patients(endeavor study),a prospective clinical trial in chronic hepatitis b patients nucleotide analogues experienced (anchor a study),sequential/combination therapy in nucleoside or nucleotide analogue (na)-suppressed chronic hepatitis b patients (npgv study).we plan to compare the hbsag negative rate and maintenance rate,the occurrence of liver cirrhosis and the occurrence rate of hepatocellular carcinoma(hcc) related to hepatitis b virus(hbv) within five years between interferon group (including interferon alone or interferon combined with other drugs) and nucleoside analogues.patients were divided into two groups based on whether they received interferon or not.

patients who treated with nucleoside analogs, and previously took part in the osst,cost,endeavor, anchor npgv studies, were included in the observational study after they finished. the patients entered the following two observation groups based on previous studies: group a: formerly interferon group (including interferon alone or interferon combined with other drugs); group b: formerly nucleoside analogue treatment group. each group was followed for five years.all patients were followed up for physical examination (vital signs, whole body examination) and laboratory assessment (hbsag quantification, hbeag quantification, hbv dna, hbv immunology marker, blood routine, blood biochemistry, alpha fetoprotein, fibroscan, liver doppler) in every six month.

Eligibility criteria:
inclusion criteria: 1. male and female patients from 18 to 65 years of age; 2. have finished the osst,cost,endeavor, anchor,npgv studies; 3. agree to participate in the study and sign the patient informed consent. exclusion criteria: 1. patients have not participated in the osst,cost,endeavor,anchor or npgv study ; 2. unable or unwilling to provide informed consent or follow the research requirements
efficacy, safety and tolerability of cx157 in treatment resistant depression

Conditions: Treatment Resistant Depression

Summary: the purpose of this study is to determine if cx157 is effective and safe in patients with treatment of treatment resistant depression over six weeks of treatment.

the primary objective of this study is to examine the efficacy of cx157 modified release tablet, 125 mg administered twice per day (bid) as compared to placebo in subjects with treatment resistant depression (trd). secondary objectives are to evaluate the safety and tolerability of cx157 modified release tablet, 125 mg bid in trd subjects and characterize steady-state pharmacokinetic profile and explore pharmacodynamic relationships.

Eligibility criteria:
inclusion criteria: 1. male or female, 20 to 65 years of age 2. able to read, understand and converse in english and provide written, dated informed consent 3. diagnosed with major depressive disorder (mdd)and treatment resistant depression(trd) 4. females on acceptable method of contraception exclusion criteria: 1. major depressive episode greater than five years 2. a history of a substance use disorder with the exception of nicotine dependence in the past 12 months 3. obsessive-compulsive disorder (ocd), panic disorder, post-traumatic stress disorder (ptsd 4. a history of schizophrenia or schizoaffective disorders 5. a history of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within the past five years 6. a history of antisocial personality disorder or borderline personality disorder 7. recent suicidal behavior and is at risk of such behavior during the course of the study 8. electroconvulsive therapy (ect) within the past five years 9. transcranial magnetic stimulation (tms) for the treatment of the current episode of depression 10. vagus nerve stimulation (vns) at any time 11. any psychoactive drugs within one to four weeks prior to the randomization visit depending on the type of drug 12. significant abnormality on the screening physical examination 13. significant cardiac abnormalities such as uncontrolled hypertension, recent myocardial infarction, congestive heart failure (chf), angina pectoris 14. a history within the past two years of significant head trauma, surgical procedure involving the brain,degenerative central nervous system disorder (e.g., alzheimer's or parkinson's disease), epilepsy, mental retardation 15. a history of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months 16. a history of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening 17. participation in an investigational study in the past one month 18. a positive screening urine test for drugs of abuse 19. female subject who is pregnant or lactating

Keywords: trd
uganda prep and harm reduction evaluation

Conditions: HIV-1-infection

Summary: this is an evaluation of programs to integrate prep into existing services for pwud. prep will be delivered according to uganda national guidelines and data from national monitoring and evaluation forms will be leveraged to address key outcomes. additionally, research components will be implemented to support greater understanding of prep use and experiences of participants engaged with the prep programs.

the first facility-based medication-assisted treatment (mat) program (with methadone) in kampala launched in 2020, providing opportunity to integrate pre-exposure prophylaxis(prep) as part of a comprehensive hiv prevention package. additionally, a community-based needle and syringe exchange program (nsp) provides opportunity to integrate prep and meet priorities of pwid while building rapport between providers and end-users. with two different service models - integrating prep into facility-based mat and community-based nsp - there is a great opportunity to optimize the integration of prep and other hiv prevention services for pwud. by integrating prep into two existing programs (mat and nsp), this study will determine uptake and persistence of prep use and leverage these programs to conduct costing research and budget impact analysis.

Eligibility criteria:
inclusion criteria: * accessing services from any of the programs implementing the integrated prep program described in this protocol * able and willing to provide informed consent * age ≥15 years exclusion criteria: * any clinical or chronic medical condition that in the opinion of the investigator would make the participant unsuitable for the study or unable to independently provide informed consent.

Keywords: pre-exposure prophylaxis substance use disorders
phase 3 placebo controlled study of nolasiban to improve pregnancy rates in women undergoing ivf/icsi

Conditions: Infertility

Summary: the primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (et) day.

the study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo transfer following in vitro fertilisation (ivf) or intra-cytoplasmic sperm injection (icsi).

Eligibility criteria:
key inclusion criteria: * indicated for ivf/icsi in the context of assisted reproductive technology (art) * follow a gonadotropin releasing hormone (gnrh) antagonist protocol, single injection of human chorionic gonadotropin (hcg) for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone. * single, fresh d3 or d5 embryo transfer key exclusion criteria: * frozen-thawed embryo transfer * more than 20 oocytes in the current controlled ovarian hyperstimulation (coh) cycle * serum p4 greater than 1.5 ng/ml on the day of hcg administration

Keywords: ivf icsi
rapid administration of insulin in sepsis

Conditions: Septic Shock

Summary: the purpose of this study is to determine if a glucose-insulin-potassium (gik) solution can be safely administered to patients with septic shock. gik has been used in thousands of critically ill patients in research studies with very few safety concerns. however, there is a lack of data in regards to patients with septic shock. there are many reasons to believe that gik would be beneficial in sepsis, including improving heart function and decreasing inflammation. this study will administer intravenous gik for 12 hours continuously and monitor 10 subjects for 24 hours. a control arm will be used and 10 patients will receive the same monitoring but will not receive gik.


Eligibility criteria:
inclusion criteria: 1. suspected or confirmed infection; 2. any two of four criteria of systemic inflammatory response: * temperature \> 100.4° or \< 96.8° f * heart rate \> 90 beats/minute * respiratory rate \> 20 breaths/min. or paco2 \< 32 mm hg * wbc \>12,000 or \ 10% bands 3. initiation of quantitative resuscitation protocol in the ed; 4. requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock exclusion criteria: 1. age \<18 years; 2. pregnancy; 3. any primary diagnosis other than sepsis; 4. established do not resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable; 5. known hyperkalemia (serum potassium \>5.5); 6. dialysis-dependent renal failure; 7. anticipated requirement for immediate surgery (within 24 hours); 8. active participation in another interventional study; 9. transferred from another hospital setting with sepsis therapy initiated; 10. inability to obtain informed consent; 11. cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment; 12. active malignancy currently under treatment (chemo- or radiation therapy); 13. known systemic allergy to insulin; 14. history of periodic paralysis associated with carbohydrate loading; 15. receiving continuous intravenous inotropic support (including dobutamine, milrinone, amrinone, and levosimendan).

Keywords: gik, septic shock, sepsis
consequences of covid-19 infection for child health and wellbeing: protocol for a prospective, observational, longitudinal study in children

Conditions: Long COVID

Summary: prospective follow-up of children with sars-cov-2


Eligibility criteria:
inclusion criteria: * children aged 0-18 years * the child sought/needed primary or secondary medical care for covid-19 * laboratory (rt-pcr,) \[18\] * 28 days - 3 months from the onset of covid-19 symptoms * parent's/carer's/guardian's consent to participate exclusion criteria: * adults