Kornimate/medical-research-clean huggingface dataset:
a phase 1 dose escalation and expansion study of shr-1916 in subjects with locally advanced or metastatic solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: this is a first in human, open-label, dose escalation and expansion phase 1 study of shr-1916 in adult patients with locally advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: 1. ability to understand and the willingness to sign a written informed consent document； 2. aged between 18-75 years old; 3. histologically or cytologically confirmed advanced or metastatic malignant tumor; 4. presence of at least of one measurable lesion in agreement to recist criteria; 5. eastern cooperative oncology group (ecog) performance status 0 to 1; 6. life expectancy \>12 weeks; 7. adequate organ performance based on laboratory blood tests; 8. women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. exclusion criteria: 1. patients who have received cytokines (il-2, ifn-α)as anti-tumor therapy within 6 months before the first dose; 2. previous systemic therapy within 28 days before the first dose; 3. previous therapeutic surgery within 28 days, and diagnostic surgery within 14 days prior to the first dose; 4. received live attenuated vaccine within 28 days before the first dose, or expected to receive live attenuated vaccine during the study treatment period; 5. patients who received systemic immunosuppressive therapy within 14 days before the first dose; 6. patients with known or suspected brain metastasis； 7. subjects with interstitial pneumonia or interstitial lung disease, with a history of interstitial pneumonia or interstitial lung disease limiting self care adl or with life-threatening respiratory compromise, with a history of pulmonary fibrosis, lasting pneumonia, drug- or radiation-induced pneumonia, and congenital pneumonia that may otherwise interfere with the judgement of immune-related pulmonary toxicity, or with any evidence of active pneumonia as shown on chest ct scans; 8. patients with history of autoimmune diseases; 9. history of immunodeficiency (including hiv infection) or organ transplantation; 10. known active hepatitis b or c infection; 11. other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
phase i study for autologous dermal substitutes and dermo-epidermal skin substitutes for treatment of skin defects

Conditions: Burn Injury; Soft Tissue Injury; Skin Necrosis; Scars; Congenital Giant Nevus; Skin Tumors

Summary: the purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoderm" (first arm) and dermo-epidermal skin substitutes "denovoskin" (second arm) transplanted onto the wound bed in children and adults.


Eligibility criteria:
inclusion criteria: * deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to: 1. acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans 2. reconstructive cases (elective surgery): scar formation after burn injuries, congenital giant nevus, skin tumours * informed consent by patients/parents or other legal representatives exclusion criteria: * infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs * patients tested positive for hbv, hcv, syphilis or hiv * patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes) * coagulation disorders as defined by inr outside its normal value, ptt \>uln and fibrinogen \<lln and / or at the investigator's discretion * previous enrolment of the patient into the current study * participation of the patient in another study within 30 days preceding and during the present study * patients or parents/other legal representatives expected not to comply with the study protocol * suspicion of child abuse * pregnant or breast feeding females * contamination derived from biopsy which could interfere with patients health * due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently * skin substitute has not been released due to production specific deviations * patients allergic to amphotericin b and gentamicin

Keywords: skin tissue-engineering autologous dermis epidermis
effect of therapeutic massage on sleep quality and stress levels in women with breast cancer

Conditions: Sleep Disturbance; Anxiety

Summary: this is a randomized control trial to test the effectiveness of therapeutic massage on the sleep quality and the stress levels in women that have completed their treatment for breast cancer.

the period following the completion of treatment for breast cancer (but also for any other type of cancer as well) is once that is accompanied by an increased uncertainty. this can often trigger increased anxiety levels and sleep disturbances. this trial tests the effectiveness of therapeutic massage as a non pharmaceutical intervention that can increase the management of stress and sleep disturbances during this period of time.

Eligibility criteria:
inclusion criteria: * women that completed their treatment * women experiencing insomnia * women experiencing anxiety * women that speak and understand greek exclusion criteria: * allergy to essential oils * use of anticoagulants * presence of edema * presence of varicose veins
study to evaluate the safety and efficacy of naldemedine (s-297995) for the treatment of opioid-induced bowel dysfunction in subjects with chronic pain

Conditions: Opioid Induced Bowel Dysfunction

Summary: the primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.

a single dose of naldemedine or matching placebo will be administered orally to each cohort of 12 participants (9 treatments, 3 placebos) in the morning of day 15 under fasted conditions. the first cohort will receive a 0.1 mg dose. cohorts will continue to be enrolled at the next higher dose level until the highest dose level (3 mg) has been achieved or until the study is discontinued due to adverse events or clinical opioid withdrawal score of \>8. a 0.03 mg dose will also be tested. a 0.01 mg dose will be tested if 4 or more subjects experience 1 or more bowel movements within the 24 hour period post dose in the 0.03 mg dosing cohort.

Eligibility criteria:
inclusion criteria: * understand and sign an informed consent form * males will agree to use an approved double-barrier method of contraception from day 1 until 1 month after study completion * subject tests negative on urine drug test unless the subject has a prescription for the drug(s) that test positive exclusion criteria: * subjects under opioid therapy for cancer-related pain or for the management of drug addiction * fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea, intermittent loose stools, or constipation * subjects who have participated in any other investigational drug study within 30 days prior to day 1 * prior exposure to s-297995

Keywords: chronic pain opioid physical dependence
towards individualized surgery in non-focal congenital hyperinsulinism

Conditions: Non-focal Congenital Hyperinsulinism

Summary: observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation

in non-focal congenital hyperinsulinism (chi) the current doctrine warrants subtotal pancreatic resection in all children who do not respond to medication. however, the rate of diabetes after these extensive resections is very high. in this study investigators show that a less aggressive approach may suffice to wean many children from all medication or to get them manageable medically.

Eligibility criteria:
inclusion criteria: * patients with non-focal congenital hyperinsulinism exclusion criteria: * patients with focal congenital hyperinsulinism
treximet (sumatriptan/naproxen sodium), formerly known as trexima, in the acute treatment of multiple migraine attacks

Conditions: Migraine Disorders; Migraine

Summary: the purpose of this study is to determine the consistency of response for treximet (sumatriptan/naproxen sodium), formerly known as trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.


Eligibility criteria:
inclusion criteria: * at least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month. * typically experiences moderate to severe migraine pain preceded by a mild pain phase. * differentiate between mild migraine pain and other headache types. * women of childbearing potential must be on adequate contraception. exclusion criteria: * pregnant and/or nursing mother. * history of cardiovascular disease. * uncontrolled hypertension. * basilar or hemiplegic migraine. * history of stroke or transient ischemic attacks (tia). * history of epilepsy or treated with anti-epileptics within past 5 years. * impaired hepatic or renal function. * history of gastrointestinal bleeding or ulceration. * allergy or hypersensitivity to aspirin or any other nsaid. * allergy or hypersensitivity to triptans. * participated in an investigational drug trial in the previous 4 weeks.

Keywords: acute migraine consistency of response satisfaction migraine early intervention
a study to investigate the safety, tolerability, and efficacy of azd0120 in adults with refractory sle

Conditions: Lupus Erythematosus, Systemic

Summary: this is a phase 1b/2, single-arm, open-label, multi-center, clinical study of azd0120, a cd19/bcma dual car t cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory systemic lupus erythematosus.

the study will enrol adult participants with refractory systemic lupus erythematosus (sle) the study will be run in 2 parts; first part is phase 1b during which the study aims to assess safety and tolerability of azd0120 in patients in refractory sle cohorts second part is phase 2, during which the study aims to assess safety, tolerability and efficacy of the selected dose, following phase 1b completion, in patients with refractory sle

Eligibility criteria:
inclusion: 1. males or females aged 18 through 70 years inclusive at the time of consent. 2. written informed consent in accordance with federal, local, and institutional guidelines. 3. must be able and willing to adhere to the study visit schedule and other protocol requirements 4. adequate hepatic, renal, pulmonary, and cardiac function 5. have a clinical diagnosis of sle according to the eular/ american college of rheumatology (acr) 2019 criteria with a positive ana ≥1:80 and a score ≥10. 6. have used at least two standard immunosuppressants (including one biological agent). 7. sledai-2k score ≥6 at screening. 8. must include a significant sle related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal. 9. for lupus nephritis: diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period class iii, iv or v ln according to the who 2003 isn/rps classification. exclusion: 1. have received prior treatment with car t therapy directed at any target. 2. have received any therapy that is targeted to cd19 and/or bcma 3. received allogenic stem cell transplant or autologous stem cell transplant. 4. an active malignancy that is progressing or requires active treatment. 5. primary immunodeficiency 6. active viral or bacterial infection

Keywords: azd0120 sle systemic lupus erythematosus lupus lupus nephritis
hypercapnia during shoulder arthroscopy

Conditions: Cerebral Ischemia

Summary: the purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.

the patients are randomly allocated to receive normocapnia or hypercapnia . after the 70º sitting position, record the mean arterial pressure (map), heart rate, and regional oxygen saturation (rso2).

Eligibility criteria:
inclusion criteria: * patients undergoing elective shoulder arthroscopic surgery exclusion criteria: * a history of age \> 65 years, morbidly obesity (bmi \> 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.
dry needling versus stretching for muscle extensibility

Conditions: Osteoarthritis, Hip

Summary: hip osteoarthritis (oa) is one of the most prevalent chronic disease in the world. currently several authors have shown the presence of active myofascial trigger points (mtrp) in the muscles surrounding the hip joint that reproduce the symptoms of the patients with hip oa. despite of the beneficial effects that have shown may conservative non-pharmacological treatments, there is a lack of studies evaluating the effects of the conservative treatments on muscle extensibility. according to the new paradigm about the presence of mtrps, the investigators decided to conduct a randomized clinical trial to compare the effects of dn intervention and stretching protocol on muscle extensibility in patients with hip oa.


Eligibility criteria:
inclusion criteria: * unilateral hip oa diagnosed medically with a x-ray tess and following the american college of rheumatology criteria exclusion criteria: * secondary osteoarthritis by a traumatism, paget disease, inflammatory or metabolic disease, congenital diseases etc. * vascular or neurological disease. * musculoskeletal pathologies in lumbar spine, pelvis or lower limbs * dn contraindications or fear of needles

Keywords: physiotherapy stretching dry needling
changes in power and cylinder axis of toric soft contact lenses (lkl)

Conditions: Visual Acuity Reduced Transiently

Summary: astigmatism is a common refractive error resulting from a toric-surfaced cornea which using a toric soft contact lens could be one of the therapy options. due to the numerous possible combinations between sphere powers, cylinder powers, and cylinder axes, manufacturers of disposable soft toric contact lenses limit their toric lens range, while still aiming to cater to the majority of astigmatic patients. due to that reason, the possibility of astigmatism patients getting a different combination of power and axis with toric soft contact lenses sold on the market will be high due to sku limitations. this research aims to ascertain the impact of altering cylinder power and axis on visual quality and convenience in astigmatism participants using toric soft contact lens. the study was conducted at kirana ciptomangunkusumo hospital, jakarta, starting in april 2020. the study is a prospective, randomized, participant-masked, crossover clinical trial where the participants were tested for the following conditions on different days using full spherocylinder correction and under-correction by 0.25, 0.50, and 0.75 dc while maintaining spherical equivalence. axis was also misaligned between -30° and +30°, in 10° steps. for each visit, the patient was examined visual acuity, contrast visual acuity using the pelli-robson, and assessed patient comfort using the vas method.


Eligibility criteria:
inclusion criteria: 1. patients aged 20 - 35 years 2. patients who do not have a spherical size (plano) to mild-moderate myopia (-1.00 d to -6.00 d) with age over 18 years 3. minimum astigmatism component ≥0.75 d and maximum ≤ 3 d in one eye 4. the best visual acuity after corrected by lkl torik is better or equal to 6/15 exclusion criteria: 1. history of previous intraocular surgery. 2. history of contact lens use in the last 6 months. 3. history of dry eyes, uveitis, glaucoma and corneal and conjunctival disorders 4. posterior segment abnormalities that reduce the quality of vision 5. patients with contraindications to wearing contact lenses 6. there are no toric lkls with exactly the strength and axes required by the patient

Keywords: toric soft contact lens
treatment of coronavirus covid-19 pneumonia (pathogen sars-cov-2) with cryopreserved allogeneic p_mmscs and uc-mmscs

Conditions: COVID-19 Pneumonia

Summary: assessment of the clinical effects of infusions of cryopreserved allogeneic multipotent mesenchymal stem cells of the placenta and umbilical cord for covid-19 patients with acute respiratory distress syndrome.

currently, cell-based therapy and especially stem cell therapy has become a promising therapeutic field, in which many see opportunities to cure incurable diseases. severe respiratory consequences of the covid-19, the disease caused by the novel sars-cov-2 coronavirus, have prompted urgent need for novel therapies. cell-based approaches, primarily using mesenchymal stem cells (mscs), have demonstrated safety and efficacy in patients with the acute respiratory distress syndrome (ards) - common manifestation of cytokine storms, and the cause of death in many covid-19 patients. mesenchymal stem cells are a powerful immunomodulator, they secrete many anti-inflammatory biologically active substances (cytokines) that reduce the inflammatory process in the lungs. also mesenchymal stem cells secrete numerous growth factors that contribute to the recovery of not only the affected lung tissue but also other organs.

Eligibility criteria:
inclusion criteria: * male or female, aged at 18 years (including) - 75 years old. * laboratory confirmation of sars-cov-2 infection by reverse-transcription polymerase chain reaction (rt-pcr) from any diagnostic sampling source. * pneumonia that is judged by x-ray imaging. in accordance with any one of the following: * dyspnea (rr ≥ 30 times / min); * finger oxygen saturation ≤ 93% in resting state; * arterial oxygen partial pressure (pao2) / oxygen absorption concentration (fio2) ≤ 300mmhg (if possible); * invasive ventilation\< 48 h. exclusion criteria: * male or female, aged at \ 75 years old. * pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures. * patients with malignant tumor, other serious systemic diseases and psychosis. * patients who are participating in other clinical trials. * inability to provide informed consent or to comply with test requirements. * co-infection of hiv, syphilis. * invasive ventilation \> 48 h. * combined with other organ failure (need organ support).

Keywords: placenta-derived mmscs i/v infusions
coparenting intervention to prevent postpartum depression

Conditions: Postpartum Depression; Anxiety

Summary: the goal of this pilot randomized controlled trial was to examine the feasibility and acceptability of an ehealth antenatal coparenting intervention (eacop) in primiparous pakistani women. the secondary purpose of the study was to see the effectives of the intervention in prevention postpartum depression in women. two hundred and twelve primiparous couples were randomized into an intervention or a control group from the aga khan university hospital. couples were randomized using consecutively numbered sealed envelopes. couples in the intervention group received the eacop intervention during pregnancy, consist of eight online videos in addition to the standard care provided at the center. both the intervention group and control group received standard care.


Eligibility criteria:
inclusion criteria: * primiparous * both women and their partners willing to participate and indicated by signed consent * up to 24 weeks of gestation (first and second trimester of pregnancy) * singleton pregnancy * able to speak, read, and understand english or urdu * have access to internet exclusion criteria: * did not have access to internet * had an epds score of \>12.

Keywords: online postpartum depression coparenting relationship
hearing preservation using dexamethasone and hyaluronic acid for cochlear implantation

Conditions: Hearing Loss

Summary: the objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation

many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection. in this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.

Eligibility criteria:
inclusion criteria: * adults (greater than 18 years old) with severe/profound, bilateral sensorineural hearing loss with indication of cochlear implantation. * hearing thresholds better than 80 db in 125 hz, 90 db in 250hz and 100 db in 500, 1000, 2000, 3000 and 4000 hz in at least 3 of these frequencies exclusion criteria: * malformation or cochlear ossification * developmental disabilities

Keywords: cochlear implantation dexamethasone acid, hyaluronic
non-cardiac chest pain: effect of cognitive therapy administered as guided self-help

Conditions: Chest Pain

Summary: this study aims to test an easily implementable web-based cognitive behaviour therapy (cbt) self-help intervention designed for non-cardiac chest pain patients, and compare effectiveness and cost-effectiveness to treatment as usual in an randomized controlled trial (rct).

most patients with chest pain referred to hospital do not have a cardiac illness. non-cardiac chest pain (nccp) is often followed by persistent distress and reduced quality of life, and societal costs are nearly equal to those of cardiac patients. research suggests that face-to-face cbt is effective, but this has not been implemented as standard treatment. we plan to test an easily implementable web-based guided self-help intervention for nccp patients. patients will be recruited at the chest pain unit at sørlandet hospital, kristiansand, and will be recruited after they have finished their cardiac examination. the intervention group will receive six web-based sessions, comprising information, exposure to physical activity, how worry can excess pain, physical reactions to pain and worry, consequences of avoidance, and specific panic treatment.

Eligibility criteria:
inclusion criteria: * non-cardiac chest pain exclusion criteria: * language difficulties * unable to perform at least moderate physical activity due to physical constraints * obvious cognitive impairment (e.g mentally retarded, psychotic, dementia or intoxicated) * no regular access to a computer/tablet computer with internet connection

Keywords: non-cardiac chest pain anxiety