Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ion904

Conditions: Healthy Volunteers

Summary: the purpose of this study is to assess the safety and tolerability of ion904.

this is a phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study of ion904 in up to 72 participants. following a screening period of up to 28 days, eligible healthy participants will be randomized to treatment and receive a single, subcutaneous (sc) dose of the assigned study drug. participants will be followed for up to 13 weeks after dosing.

Eligibility criteria:
inclusion criteria: 1. must be healthy males, or females of non-childbearing potential, aged 18 to 65 at the time of informed consent 2. females must be either surgically sterile or post-menopausal; males must be abstinent, surgically sterile, or if engaged in sexual relations with a woman of childbearing potential, a highly effective contraceptive method must be used from the time of signing the informed consent form until at least 13 weeks after the last dose of study drug or the healthy participant must be abstinent through this time period 3. willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) for at least 24 hours prior to study visits 4. body mass index (bmi) requirements between 18 and 35 kg/m\^2 exclusion criteria: 1. clinically significant abnormalities in medical history or physical examination 2. uncontrolled arterial hypertension 3. active infection with human immunodeficiency virus (hiv), hepatitis c or hepatitis b or prior treatment for hepatitis c 4. treatment with another investigational drug, biological agent, or device within 1 month of screening 5. history of bleeding diathesis or coagulopathy 6. regular use of alcohol within 6 months prior to screening, or use of soft drugs within 3 months prior to screening, or hard drugs within 1 year prior to screening, or positive urine drug screen at screening 7. history of any severe (e.g., anaphylaxis) drug allergies 8. history of hypersensitivity to other antisense oligonucleotides (asos) 9. concomitant medication restrictions: over-the-counter or prescription medications within 14 days, prior to dosing on day 1. accepted exceptions are: * acetaminophen (paracetamol) up to 2 grams per day (g/d) or ibuprofen up to 2.4 g/day taken sporadically for analgesia * thyroid hormone replacement therapy provided participant is stable on replacement therapy (and participant is euthyroid) * other possible exceptions must be reviewed and acknowledged by the investigator in consultation with sponsor's medical monitor 10. blood donation of 50 to 499 ml within 30 days of screening or of \> 499 ml within 60 days of screening

Keywords: healthy participants hypertension
laser cataract surgery with the femtosecond laser technology

Conditions: Cataracts

Summary: the purpose of this study is to prove the efficacy and safety of the femtosecond laser to create a clear corneal incision during cataract surgery.


Eligibility criteria:
inclusion criteria: * study participants must have a cataract for which phacoemulsification extraction and posterior iol implantation has been planned in at least one eye. * study participants should be capable of achieving better than 20/30 snellen best corrected distance vision after cataract extraction and iol implantation. * the surgeon may use the mento potential acuity meter (pam)laser interferometer, mcintyre pinhole, or his/her judgement to estimate the patient's potential acuity. exclusion criteria: * concurrent participation or participation in the last 30 days in other clinical trials. * known steroid iop responder. * taking medications that may affect vision, iop, or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.). * acute or chronic disease or illness that would increase risk or confound study results(e.g. uncontrolled diabetes mellitus, immunocompromised, etc.). * uncontrolled systemic or ocular disease. * corneal abnormalities (e.g. stromal, epithelial, or endothelial dystrophies) * pseudoexfoliation. * ocular hypertension (\>or =20hg) or glaucomatous changes in the optic nerve.
cbt-i for psychosis: guidelines, preliminary efficacy, and functional outcomes

Conditions: Insomnia; Psychosis

Summary: the goal of this project is to develop guidelines for the clinical tailoring of cognitive behavioral therapy for insomnia (cbt-i) for veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of cbt-i for improving sleep-related functional outcomes in this population.

the goal of this project is to develop guidelines for the clinical tailoring of cognitive behavioral therapy for insomnia (cbt-i) for veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of cbt-i for improving sleep-related functional outcomes in this population. specific aim 1: develop empirically-derived guidelines for the clinical tailoring of cbt-i materials and procedures for veterans with psychotic disorders through an iterative process with input from veteran clients, cbt-i experts and providers, as well as those with expertise in psychotic disorders. specific aim 2: establish the acceptability of cbt-i for veterans with psychotic disorders and insomnia when delivered using guidelines developed in specific aim 1 in order to make further refinements to the guidelines in a preliminary trial with 6 veterans with psychosis and insomnia. specific aim 3: conduct a randomized controlled trial (n=60) to test the feasibility and preliminary efficacy of cbt-i in producing positive changes at post-treatment and 3-month follow-up on the outcomes of insomnia symptoms, sleep quality, and functioning.

Eligibility criteria:
inclusion criteria: 1. diagnostic and statistical manual of disorders, 5th edition (dsm 5) diagnosis of schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), or major depression with psychotic features (296.24, 296.34). 2. self-reported symptoms of insomnia via an insomnia severity index (isi) score of 15 or greater. 3. age between 18 and 80 as determined by medical record review. 4. participation in outpatient mental health services at a designated study site. 5. sufficient clinical stability to participate as deemed by a treatment provider. 6. capacity to sign informed consent. exclusion criteria: 1. current problematic drug or alcohol use that impacts functioning and study engagement, as deemed by a treatment provider. 2. currently in cbt-i treatment, determined by medical records. 3. positive screen for sleep apnea via a portable sleep apnea screening device or a prior diagnosis of sleep apnea in medical records.

Keywords: schizophrenia and disorders with psychotic feature mental disorders insomnia disorder
a phase 1/2 trial of sp-101 for the treatment of cystic fibrosis (cf)

Conditions: Cystic Fibrosis

Summary: this is a phase 1/2 multicenter, open-label, single dose trial of sp-101 investigational gene therapy in adults with cf who are ineligible for or intolerant to cftr modulator therapy.

this multi-center study is a first-in-human, single ascending dose, phase 1/2 trial to evaluate the safety, pharmacokinetics, and pharmacodynamics of various dose levels in people with cf who are ineligible or intolerant to cftr modulator therapy.

Eligibility criteria:
inclusion criteria: 1. males or females, age 18 to 65 years at screening visit, inclusive 2. diagnosis of cf 3. ppfev1 value between 50-100% (inclusive) 4. resting oxygen saturation ≥94% on room air by pulse oximetry 5 . clinically stable cf disease as assessed by the investigator and not requiring any new class of interventional treatment within the last 3 months prior to screening exclusion criteria: 1. any change in established pulmonary treatment (including antibiotics) within 28 days prior to screening visit. however, inhaled beta-agonists can be included within 2 weeks prior to screening visit. 2. clinically significant episode of hemoptysis (\>50 ml or ¼ cup or 10 teaspoons per day) within 12 weeks prior to dosing with study drug on day 1 3. lung infection with mycobacterium abscessus associated with a more rapid decline in pulmonary status 4. currently receiving treatment for active lung infection with burkholderia cenocepacia or burkholderia dolosa 5. history of solid organ or hematological transplantation 6. history of clinically significant cirrhosis with or without portal hypertension 7. history of pulmonary hypertension 8. history of cardiotoxicity, a history of known coronary artery disease, and/or existing cardiomyopathy 9. current active fungal infection (not just a positive culture), acute blood, lung, or bladder infection, clinically significant hepatic or renal dysfunction, and/or viral infection (including human immunodeficiency virus or hepatitis virus b or c) requiring the initiation of new therapy within 30 days prior to screening 10. history of allergic bronchopulmonary aspergillosis (abpa) 11. uncontrolled diabetes mellitus, as evidenced by hemoglobin a1c \>9% at screening 12. clinically significant laboratory abnormalities at screening 13. subjects with any medical condition or abnormal laboratory result that, in the opinion of the investigator, will interfere with the safe completion of the study 14. subjects who received any investigational products within 30 days (or 5 therapeutic half-lives, whichever is longer) prior to screening 15. subjects who have previously received any gene therapy agent 16. subjects with known sensitivity to sp-101, doxorubicin or its excipients

Keywords: gene therapy sp-101 aav doxorubicin inhaled augmenter
knee alignment contributions to anterior cruciate ligament (acl) injury

Conditions: Knee Injuries

Summary: this study evaluates the the anatomic factors of the knee that may predispose to acl injury.

despite intense study of anterior cruciate ligament injury during the past three decades, the mechanisms of this injury have not been clearly defined. a recent study by the principle investigator identified differences in leg alignment when a single leg landing during a sports activity resulted in a torn acl and when it did not (provocative versus control alignment, respectively). the purpose of the study is to quantify the tibiofemoral alignment in the lateral compartment of the knee in the provocative landing position and the control landing position. in order to elucidate possible mechanisms of acl injury material and methods: 25 normal controls will be recruited from the greater washington dc population. magnetic resonance images in the sagittal plane will be acquired for a single leg of each subject. these images will cover the lateral compartment of the knee and will be acquired with the leg in three positions, one that emulates the injury position, one that exagerrates the injury position, and one that emulates the control landing position. statistical analysis of the measurements between the provocative, exagerrated provocative, and control positions will then be performed. these insights could then be applied to improving training focused on reducing the incidences of acl rupture; improving bracing designs to help athletes most at risk of acl rupture or those recovering from acl injury/surgery; and improving acl replacement surgeries.

Eligibility criteria:
inclusion criteria: * healthy controls * ages 18-45 years old exclusion criteria: * previous knee injury or surgery * metal implants in body

Keywords: anterior cruciate ligament knee joint
treatment of ulcerative colitis with rectal instillation of qinghua quyu prescription(qhqyp)

Conditions: Ulcerative Colitis

Summary: this study will enroll 60 patients with mild to moderate active ulcerative colitis as subjects. they will be randomly divided into two groups: the tcm group received qhqyp rectal instillation, while the control group received mesalazine enema. the treatment period for both groups was 8 weeks. the modified mayo activity index will be used as the main evaluation index. secondary evaluation indices will include the underwater endoscopic severity index (uceis) score, endoscopic baron score, mucosal histological score (geboes index), chinese medicine syndrome efficacy evaluation, quality of life score, physicochemical indicators reflecting disease activity or remission, intestinal microbiota indicators, and changes in inflammation and immune-related indicators in colonoscopy biopsy tissues. safety indicators were also monitored.


Eligibility criteria:
inclusion criteria: 1. meets the diagnostic criteria for active ulcerative colitis, with clinical severity being mild or moderate and the lesion range being limited to the rectum or left colon and not extending beyond the splenic flexure. 2. traditional chinese medicine diagnosis indicates the presence of damp-heat syndrome in the large intestine. 3. between the ages of 18 and 65, regardless of gender. 4. informed consent and voluntary participation are required. the process of obtaining informed consent should comply with gcp regulations. exclusion criteria: 1. patients with severe disease condition. 2. patients with infectious colonic diseases such as chronic schistosomiasis, bacterial dysentery, amoebic dysentery, intestinal tuberculosis, as well as non-infectious colonic diseases such as crohn's disease, ischemic bowel disease, and radiation enteritis. 3. patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic megacolon, colon cancer, rectal cancer, and anal diseases. 4. pregnant or lactating women. 5. patients with severe primary heart, liver, lung, kidney, blood or other severe diseases that affect their survival. 6. patients with disabilities as defined by law (blind, deaf, mute, intellectually disabled, mentally ill, physically disabled). 7. patients with suspected or confirmed history of alcohol or drug abuse. 8. other conditions that may reduce the likelihood of enrollment or complicate enrollment, as determined by the researcher, such as frequent changes in work environment that may lead to loss of follow-up. 9. patients with allergies to two or more drugs or foods, or with a history of allergy to the components of this medication. 10. patients currently participating in other clinical trials of medications.
a study of pyrotinib in combination with trastuzumab and docetaxel in patients with her2 metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have her2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.


Eligibility criteria:
inclusion criteria: 1. her2 positive recurrent or metastasis breast cancer. 2. patients with measurable disease are eligible. 3. eastern cooperative oncology group(ecog) performance status 0 or 1. 4. adequate organ function. 5. signed, written inform consent obtained prior to any study procedure. exclusion criteria: 1. history of anti-cancer therapy for mbc（with the exception of one prior hormonal regimen for mbc）. 2. history of her tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting. 3. assessed by the investigator to be unable receive systemic chemotherapy. 4. history of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. 5. pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
a safety, tolerability and efficacy study of ace-011 in patients with osteolytic lesions of multiple myeloma

Conditions: Multiple Myeloma

Summary: multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ace-011 in patients with osteolytic lesions of multiple myeloma.


Eligibility criteria:
key inclusion criteria: * patient at least 18 years of age with stage ii or iii multiple myeloma * one or more lytic bone lesions * if currently receiving bisphosphonate therapy, have been on a stable dose for ≥ 2 months before dosing day 1 or must not have received bisphosphonates within 2 months of dosing day 1 * if patient has undergone previous autologous or allogenic hematopoietic stem cell transplantation (hsct), they must be stable (in the opinion of the investigator) and be a minimum of 6 months since hsct * has planned hsct for the duration of the study * has moles or lesions that are currently undiagnosed, but are suspect for malignancy * has an underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions, such as a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, paget's disease of the bone, or osteomalacia; patients with a diagnosis of osteoporosis prior to multiple myeloma diagnosis are eligible to participate. key exclusion criteria: * known underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions * history of polyneuropathy ≥ grade 3 * patients with plasma cell leukemia * planned stem cell transplant (hsct) or radiation for the duration of the study * skeletal related event within 2 weeks of study enrollment * has received erythropoiesis-stimulating agents (esas) within the last 21 days or is planned to receive esas during the course of the study * has received anti-myeloma therapy within the last 21 days * is scheduled to receive local radiation to bone during the course of the study * has taken estrogen, androgen, anabolic steroids, calcitonin or other bone-active drugs within 4 months of study enrollment * woman of childbearing potential (not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
photobiomodulation for prevention of chemotherapy-induced peripheral neuropathy in women with breast cancer

Conditions: Peripheral Nervous System Diseases AND Breast Neoplasms

Summary: double-blind superiority randomized controlled clinical trial. objective of the study: to evaluate the effectiveness of photobiomodulation using the led board in the prevention of peripheral neuropathy in the lower limbs in women with breast cancer undergoing chemotherapy at the cancer hospital iii of the national cancer institute (hciii/inca).

materials and methods: this is a single-blind superiority randomized controlled clinical trial. women aged over 18 years, with breast cancer in stages i to iiic and who have an indication for curative treatment with neoadjuvant or adjuvant chemotherapy at hciii/inca will be eligible. patients with a previous diagnosis of another primary cancer will be excluded; patients undergoing surgery and/or chemotherapy at another institution; patients who previously had altered sensitivity in the feet; patients who are unable to answer the questionnaires and patients unable to receive photobiomodulation due to acute infections in the lower limbs. after recruitment, the women will be allocated into three groups: two intervention groups (use of the iv and v led board; and iv, v and violet) and a control group (use of the led board without light emission). peripheral neuropathy, pain, global muscle strength, body balance, sensitivity, health-related quality of life and related independent variables will be evaluated, such as the characteristics of the patient, the tumor and the oncological treatment performed. data analysis: statistical analysis will be conducted following intention-to-treat principles. data normality will be tested using the kolmogorov smirnov test, considering as normal distribution those with p \> 0.05.

Eligibility criteria:
inclusion criteria: * women aged over 18 years, with breast cancer in stages i to iiic and who have an indication for curative treatment with neoadjuvant or adjuvant chemotherapy in hciii/inca. exclusion criteria: * patients with a previous diagnosis of another primary cancer * patients undergoing surgery and/or chemotherapy at another institution * patients who previously had altered sensitivity in the feet * patients who are unable to respond to questionnaires * patients unable to receive photobiomodulation due to acute lower limb infections

Keywords: breast cancer peripheral neuropathy chemotherapy photobiomodulation
use of vibration anesthesia device in intratympanic injections

Conditions: Intratympanic Injections; Sudden Hearing Loss

Summary: summary intratympanic injections commonly cause pain in the patients. intratympanic steroid injection (its) application can be performed by direct injection without anesthesia or with local anesthesia induced by lidocaine spray, lidocaine injection, topical phenol, pantocaine, emla cream (lidocaine+prilocaine) or vibration anesthesia device (vad). the advantage of vad application over other anesthetic agents was that it eliminated the need to use local anesthetics that may disrupt wound healing. in addition, inducing anesthesia with vad can be considered as an alternative method in patients allergic to drugs.

abstract in this study, we aimed to compare the efficacy of four methods including topical lidocaine spray, local anesthetic cream, vibration anesthesia device (vad), and saline drops (control group) in the reduction of pain after intratympanic steroid injections (its's) and to demonstrate the effectiveness of vad use. the prospective study included 40 patients aged 18-70 years with idiopathic sudden sensorineural hearing loss. prior to each its, all the four methods including local anesthetic cream (emla® cream, astrazeneca plc), lidocaine spray (vemcain® spray), vad (blaine®, blaine labs, santa fe, usa), and saline drops (control) were administered in each patient. after each its, pain assessment was performed using visual analogue scale (vas), numerical rating scales (nrs), and verbal rating scales (vrs).

Eligibility criteria:
inclusion criteria: * aged 18-70 years with idiopathic sudden sensorineural hearing loss exclusion criteria: * history of otologic surgery, * recent ototoxic drug use, * congenital inner ear malformation, * history of chemoradiotherapy due to malignant neoplasia, * presence of acute or chronic otitis media, * age under 18 years, over 70 years * history of local anesthesia allergy, * coagulation abnormality, * pregnant and lactating women, * hearing cases with other neurootological diseases

Keywords: sensorineural hearing loss vad intratympanic steroid pain sudden hearing loss