Kornimate/medical-research-clean huggingface dataset:
a drug-drug interaction study of ctl0801 and ctl0802 compared to coadministration in healthy adult volunteers

Conditions: Health, Subjective

Summary: this is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of ctl0801 and ctl0802 at steady state when administered alone or in combination with repeated oral doses in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * a subject who weighs 50 kg or more (45 kg or more for women) * a subject who does not have clinically significant congenital or chronic diseases * a subject who is judged to be eligible to participate by the results of diagnostic tests by the principal investigator * a subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 7 days after the last dose of the investigational drug * a subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, the characteristics of the investigational drugs, and expected adverse reactions exclusion criteria: * a subject who has a known digestive system, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and genitourinary system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmic system or has any past history of them * a subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases * a subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month of the first administration or has taken drugs that may affect the study within 10 days of the first administration (however, participation can be possible considering pharmacokinetic·pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs etc) * a subject who has participated and administered other investigational drugs in other clinical trials or bioequivalence studies within 6 months of the first administration * a subject who is judged ineligible for participation in this study by the principal investigator * a female volunteer who is pregnant or lactating
a phase 3 study of vx-445 combination therapy in subjects with cystic fibrosis heterozygous for the f508del mutation and a minimal function mutation (f/mf)

Conditions: Cystic Fibrosis

Summary: this study will evaluate the efficacy of vx-445 in triple combination (tc) with tezacaftor (tez) and ivacaftor (iva) in subjects with cystic fibrosis (cf) who are heterozygous for f508del and a minimal function mutation (f/mf subjects).


Eligibility criteria:
key inclusion criteria: * heterozygous for the f508del mutation (f/mf) * forced expiratory volume in 1 second (fev1) value ≥40% and ≤90% of predicted mean for age, sex, and height key exclusion criteria: * clinically significant cirrhosis with or without portal hypertension * lung infection with organisms associated with a more rapid decline in pulmonary status * solid organ or hematological transplantation other protocol defined inclusion/exclusion criteria may apply
capravirine (ag1549) in combination with viracept and two nrtis in hiv infected patients who failed an initial nnrti containing regimen

Conditions: Human Immunodeficiency Virus

Summary: this is a 48 week study that is intended for hiv infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (nnrti) and who are now failing that regimen. they must be currently on their failing regimen to be eligible.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years old * hiv rna level \>1000 copies/ml at screening * cd4 \>50 cells/ul at screening * patient is currently taking a regimen that includes an nnrti plus 2 nrtis for at least 28 days and is currently failing this regimen * patient has adequate hematology tests (absolute neutrophil count \>1000/ul, platelets\>75,000ul, hemoglobin 9g/l) * patient has adequate renal function (serum creatinine of \<1.5 upper limit of normal) * patient has adequate liver function (ast, alt, and bilirubin \< 2.5 upper limit of normal) exclusion criteria: * previous use of protease inhibitors (except if patient has short duration of pi and was switched for tolerability reasons when viral load was \<50 copies) this exception does not include viracept * women who are pregnant or lactating

Keywords: hiv nnrti failure hiv infections
attain model 4196 left ventricular (lv) lead

Conditions: Heart Failure

Summary: heart failure is a progressive disease that decreases the pumping action of the heart. this may cause a backup of fluid in the heart and may result in heart beat changes. when there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. in certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (crt) may be prescribed. crt is similar to a pacemaker. it is placed (implanted) under the skin of the upper chest. crt is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (flexible insulated wires) that are inserted through the veins to the heart. the purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).


Eligibility criteria:
inclusion criteria: * qrs greater than or equal to 120 milliseconds (the qrs interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. a wide qrs (more than 120) suggests that there is a conduction problem, or block, in the ventricles.) * left ventricular ejection fraction (ef) less than or equal to 35 percent (ejection fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. the higher the ef the more blood the ventricle is pumping.) * subject has moderate to severe heart failure despite medications exclusion criteria: * subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt * subjects with chest pain or who have had a heart attack within the past month before enrollment in the study * subjects that have had certain surgeries on their heart within the past three months * subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)

Keywords: heart failure cardiac pacing left ventricular lead cardiac resynchronization therapy
safety and preliminary efficacy study of pds-1.0 in patients with neovascular amd

Conditions: Age-Related Macular Degeneration

Summary: this study will evaluate the safety and preliminary effectiveness of pds 1.0 in patients with neovascular amd.


Eligibility criteria:
key inclusion criteria: * diagnosis of cnv secondary to amd confirmed by fluorescein angiography, not previously treated * retinal thickness due to edema of at least 300um in the study eye * best corrected visual acuity of 20/80 or worse in the study eye * best corrected visual acuity of 20/40 or better in the fellow eye exclusion criteria: * evidence of scarring cnv (e.g. geographic atrophy) in the study eye * fibrosis \>75% of lesion area in the study eye
low back pain and motor control dysfunction after pregnancy- the possible role of abdominal rectus muscle diastasis

Conditions: Diastasis Recti

Summary: the aim of this study was to compare participants with increased symptoms after index pregnancy with those reporting no change in back pain or subjective movement control and analyzed their inter rectus distance (ird). this study is a case-control study of a cohort of women who had delivered a year earlier. we recruited participants with increased symptoms (n=14) after index pregnancy and controls (n=41) and recorded their inter rectus distance with ultrasound. a questionnaire was filled, and an ultrasound was performed two times for the study groups.

a case control study was conducted in helsinki university hospital during 1.1.2018-31.3.2021. participants were enrolled in pregnancy screening unit. exclusion criteria was pregnancy during the second questionnaire and body mass index over 28kg/m2. the first questionnaire was filled and the baseline width of linea alba was measured by abdominal ultrasound (us) in connection of the first early pregnancy screening during 1.1.2018-8.3.2019. the second electronic questionnaire was sent a year after the expected delivery timing. two screening questions were used to grade the participants. altogether 36 individuals scored at least five points reflecting to substantial increase in symptoms in screening questions in the second questionnaire after pregnancy out of which fourteen participants were randomly recruited. another 94 individuals scored the lowest possible two points implicating no change in ones bodily experience. three controls per case were recruited, altogether 42 controls and with one dropout the total number of controls was 41. all participants had at least 12 months from the last delivery. two physiotherapists conducted motor control tests and the width of linea alba was measured with a high-end ultrasound. the physiotherapists were blinded with group allocation and the previous ird measurement. participants did not know their own exposure status or their ird when answering the questionnaires.

Eligibility criteria:
inclusion criteria: * age over 18 years exclusion criteria: * body mass index (bmi) over 28 kg/m2 ( weight and height combined to report bmi in kg/m\^2 * ongoing pregnancy during the second questionnaire, a year after the index pregnancy
study of efficacy and safety in polycythemia vera subjects who are resistant to or intolerant of hydroxyurea: jak inhibitor inc424 (incb018424) tablets versus best available care: (the response trial)

Conditions: Polycythemia Vera

Summary: this pivotal phase iii trial (cinc424b2301) is designed to compare the efficacy and safety of ruxolitinib (inc424) to best available therapy (bat) in participants with polycythemia vera (pv) who are resistant to or intolerant of hydroxyurea (hu).


Eligibility criteria:
inclusion criteria: * participants diagnosed with pv for at least 24 weeks prior to screening according to the 2008 world health organization criteria * participants resistant to or intolerant of hydroxyurea * participants with a phlebotomy requirement * participants with splenomegaly (palpable or non-palpable) and a spleen volume, as measured by mri (or ct in applicable participants ), of greater than or equal to 450 cubic centimeters * participants with an eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 exclusion criteria: * women who are pregnant or nursing * participants with inadequate liver or renal function * participants with significant bacterial, fungal, parasitic, or viral infection requiring treatment * participants with an active malignancy within the past 5 years, excluding specific skin cancers * participants with known active hepatitis or hiv positivity * participants who have previously received treatment with a jak inhibitor * participants being treated with any investigational agent

Keywords: incb018424
efficacy of corticosteroid and local anesthetic injections patients with concomitant pes anserine bursitis

Conditions: Osteoarthritis Knees Both

Summary: to evaluate the efficiencies of local corticosteroid injections and local anesthetics in patients with concomitant pes anserine bursitis and osteoarthritis.

several treatment options have been tried with varying success rates, including nonsteroidal anti-inflammatory drugs, physiotherapy modalities, cold application with ice-packs, and injection of local anesthetics and/or corticosteroids. despite a relatively high frequency of this painful condition, surprisingly, few studies have evaluated treatment strategies in randomized controlled study design. to the best of our knowledge, no study in the literature made a comparison of the efficacy of local anesthetic and corticosteroid injections in addition to physiotherapy in the treatment of pes anserine bursitis yet. thus, we aimed to compare the treatment efficacies of physiotherapy alone, physiotherapy + local anesthetic injection, and physiotherapy + local corticosteroid injection in a randomized controlled study design in patients with concomitant osteoarthritis and pes anserine bursitis.

Eligibility criteria:
inclusion criteria: * patients having stage ii-iv knee osteoarthritis along with pes anserine bursitis * symptom onset for more than three months exclusion criteria: * patients who underwent knee operations * had an inflammatory rheumatic disease * had a history of knee trauma * had a meniscus tear * valgus/varus deformity * received injection treatment to pes anserine bursa during the preceding year

Keywords: pain knee rehabilitation
evaluation of acetabular perfusion after ganz osteotomy by positron emission tomography

Conditions: Osteoarthritis

Summary: the purpose of this study is to examine the blood flow in acetabulum after periacetabular osteotomy by positron emission tomography (pet).

as a consequence of periacetabular osteotomy the blood flow in acetabulum is decreased. after periacetabular osteotomy has been performed there is fine contact between the osteotomised acetabulum and the rest of the pelvis and the potential for healing is good. however, it has not been investigated how much the blood flow in acetabulum is changed after surgery. the blood flow is considered to be vital for how the pelvis heals after surgery. most likely, the blood flow is important in relation to which degree osteoarthritis can be prevented after periacetabular osteotomy. it is possible to estimate the blood flow by positron emission tomography of the dysplastic hip joint pre- and postoperatively. in this study the blood flow and fluoride uptake is quantified by positron emission tomography based on measurements of o-15 water and f-18 fluoride.

Eligibility criteria:
inclusion criteria: * patients with radiologically diagnosed hip dysplasia (ce-angle \< 25°). * patients with osteoarthritis graded 0, 1 or 2 defined according to tönnis' classification. patients with pain from hip * age \> 18 years. * minimum 110° flexion in hip joint and closed growth zones in the pelvic. * informed consent. exclusion criteria: * patients with neurological diseases * patients with calvé-legg-perthes syndrome. * patients where an femoral intertrochanteric osteotomy is necessary. * patients with medical sequelae after earlier hip surgery. * females who are pregnant. * patients with metal implants.

Keywords: pet periacetabular osteotomy
descriptive study of a cohort of orbital solitary fibrous tumors

Conditions: Orbital Tumor

Summary: orbital solitary fibrous tumors are rare tumors with an intermediate potential of malignancy. orbital solitary fibrous tumors' prognostic criteria are still poorly understood. some patients with orbital solitary fibrous tumors have been treated at the adolphe de rothschild foundation hospital. this cohort will be studied to describe the recurrence rate and to identify predictive factors of recurrence or metastasis.


Eligibility criteria:
inclusion criteria: * patients treated at the adolphe de rothschild foundation hospital for an orbital solitary fibrous tumor between 01/01/2014 and 09/30/2020 exclusion criteria: * opposition of the patient (or of the relative if the patient is deceased) * patients benefiting from a legal protection measure * pregnant or breastfeeding woman
the effect of pulmonary rehabilitation on bronchoscopic volume reduction process success

Conditions: Emphysema; Pulmonary Rehabilitation; Bronchoscopic Lung Volume Reduction

Summary: the data of patients undergoing bronchoscopic volume reduction procedure will be analyzed retrospectively. patients will be divided into two groups as patients with and without pulmonary rehabilitation before the procedure, and changes in functional levels of patients will be compared.

the data of patients who underwent bronchoscopic volume reduction between january 2013 and march 2019 will be examined. patients will be divided into two groups as pulmonary rehabilitation applied (pr group) and not applied (control group) before the procedure. changes in the parameters of initial and rehabilitation follow-up will be examined.

Eligibility criteria:
inclusion criteria: * between the ages of 18-75 * patients with a diagnosis of emphysema and bronchoscopic procedures exclusion criteria: • patients who develop complications related to the procedure after bronchoscopic procedure.
bladder capacity as objective measure of intravesical treatment of newly diagnosed ic

Conditions: Interstitial Cystitis; Painful Bladder Syndrome

Summary: a comparative study of subjective outcomes following intravesical treatment of interstitial cystitis (ic) is lacking in the literature. furthermore, an objective measure to determine the efficacy of intravesical treatment for interstitial cystitis has yet to be defined. change in bladder capacity following therapy has been investigated; however, a formal statistical analysis of its utility in determining efficacy has yet to be performed. the primary objective of this prospective, randomized study is to determine whether there is a significant difference in subjective improvement in ic symptoms in women with newly diagnosed ic when treated with either dimethyl sulfoxide (dmso) or bupivacaine, triamcinolone, and heparin (bth) instillations. the secondary objective is to determine whether change in bladder capacity can be used as an objective measure of response to intravesical therapy for newly diagnosed interstitial cystitis. our long-term goals are to improve the scientific understanding of therapy for interstitial cystitis, to improve patient counseling prior to initiation of treatment, and to better identify patients likely to receive inadequate relief of symptoms following intravesical treatment so that an alternative treatment can be pursued.


Eligibility criteria:
inclusion criteria: * newly diagnosed interstitial cystitis/painful bladder syndrome exclusion criteria: * history of pelvic radiation, a history of bladder cancer, or a history of bladder resection

Keywords: dimethyl sulfoxide (dmso) intravesical instillations bupivacaine, triamcinolone, and heparin (bth) bladder instillations
a phase iii, randomised study of adjuvant dato-dxd in combination with rilvegostomig or rilvegostomig monotherapy versus standard of care, following complete tumour resection, in participants with stage i adenocarcinoma nsclc who are ctdna-positive or have high-risk pathological features

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase iii, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant dato-dxd in combination with rilvegostomig compared with soc, after complete surgical resection (r0) in participants with stage i adenocarcinoma nsclc who are ctdna-positive, as determined by the sponsor-designated ctdna assay, or have at least one high-risk pathological feature.

the primary objective of the study is to assess the efficacy and safety of adjuvant dato-dxd in combination with rilvegostomig relative to soc, after complete surgical resection (r0) in participants with stage i adenocarcinoma nsclc who are ctdna-positive, as determined by the sponsor-designated ctdna assay, or have at least one high-risk pathological feature.

Eligibility criteria:
inclusion criteria: 1. histologically documented treatment-naive stage i (t \< 4 cm, ajcc 8th ed) adenocarcinoma nsclc 2. complete surgical resection (r0) of the primary nsclc 3. unequivocal no evidence of disease at post-surgical 4. pre-surgical ctdna-positive result (stage ia or ib) or presence of at least one high-risk pathological feature (visceral pleural invasion (vpi), lymphovascular invasion (lvi), high-grade histology) (stage ib only) 5. ecog of 0 or 1, life expectancy of \> 6 months and complete recovery after surgery 6. adequate bone marrow reserve and organ function exclusion criteria: 1. sensitizing egfr mutation and/or alk alteration 2. history of non-infectious ild/pneumonitis that required steroids, has current ild/pneumonitis, or has suspected ild/pneumonitis that cannot be ruled out by imaging at screening 3. significant pulmonary function compromise 4. history of another primary malignancy within 3 years (with exceptions) 5. any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease 6. active or prior documented autoimmune or inflammatory disorders (with exceptions) 7. active infection with tuberculosis, hepatitis b or c virus, hepatitis a, or known hiv infection that is not well controlled 8. history of active primary immunodeficiency 9. clinically significant corneal disease

Keywords: non-small cell lung cancer nsclc adenocarcinoma stage i datopotamab deruxtecan dato-dxd adjuvant treatment rilvegostomig standard of care pemetrexed carboplatin cisplatin vinorelbine etoposide uft ctdna-positive high-risk pathological features
effects of preoperative using of eye patches on prevention of emergence agitation after cataract surgery

Conditions: Agitation; Child; Anesthesia

Summary: this study is a single-center, prospective, randomized, controlled trial. to investigate if preoperative using of eye patch will decrease emergence agitation, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists.

this study is a single-center, prospective, randomized, controlled trial. to investigate whether preoperative using of eye patches will decrease emergence agitation or not, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists. the investigators will recruit 180 children undergoing elective cataract surgery, divided into 2 groups by random method. experimental group will cover the effected eye for 3 hours before the operation, while the control group will not. then the investigators will observe and mesure the incidence of emergence aditation in each group, to assess whether preoperative patch shading can reduce the incidence of postoperative agitation.

Eligibility criteria:
inclusion criteria: 1. preschool patients undergo elective cataract surgery, whose age are 3 to 7 years. 2. patients' parents agree to participate in the trial, and sigh the informed consent. exclusion criteria: 1. patient who can not communicate with medical workers preoperatively. 2. both of patient's eyes are covered postoperatively. 3. patient's parents refuse to sign informed consent. 4. the investigators do not think such patient is suitable for our research 5. the patient has serious arrhythmia, abnormal cardiac defect. 6. the patient has suffered from pneumonia, asthma symptoms, bronchitis, or upper respiratory tract infection recent two weeks. 7. the patient has serious disease of the nervous system. 8. the patient has the allergic history of any drug involved in this clinical trial.

Keywords: emergence agitation eye patch preschool children