Kornimate/medical-research-clean huggingface dataset:
impact of the covid-19 pandemic and hrqol in cancer patients and survivors

Conditions: COVID-19 Infection; Malignant Solid Neoplasm

Summary: this study uses questionnaires to gain an understanding of how experiences during the covid-19 pandemic, regardless of covid-19 status, may have impacted health-related quality of life (hrqol) and other areas such as covid-19-specific psychological distress, disruptions to health care, finances and social interactions in cancer patients. the coronavirus disease 2019 (covid-19) is an infectious disease that is caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2). the information learned from this study will guide the development of psychosocial programs to improve patient care and outcomes in cancer patients and survivors in the context of facing a global pandemic.

primary objectives: i. assess experiences during the coronavirus disease-2019 (covid-19) pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends); covid-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and social disruptions; perceived benefits and social support; and hrqol and other psychosocial and behavioral factors in cancer survivors who participated in one of three prior clinical trials. ii. evaluate the extent to which covid-19 experiences are associated with covid-19 specific psychological distress, health, financial and social disruptions, perceived benefits and social support, and hrqol. iii. evaluate the extent to which resiliency factors such as social support and perceived benefits assessed concurrently and other psychosocial measures assessed in the prior trials moderate the effects of covid-19 experiences on covid-19-specific psychological distress and hrqol. iv. examine group differences in the outcomes assessed in the protocol relative to prior group assignment in the behavioral clinical trials. outline: participants complete a survey online over 35-45 minutes about their experiences regarding the covid-19 pandemic.

Eligibility criteria:
inclusion criteria: * prior patients who participated in one of the following protocols: 2012-0112, 2009-0976, or 2005-0035 * has an active email address or can be contacted via mychart or personal email exclusion criteria: * no evidence of consent from prior clinical trials
mva to improve the pregnancy outcome in aged infertility women with assisted reproductive technology

Conditions: Infertility, Female; IVF; Reproductive Disorder; Oocyte

Summary: the goal of this clinical trial is to test mva on improving pregnancy outcome in elderly infertile patients undergoing invitro fertilization (ivf). the main question it aims to answer is whether mva could improve embryo haploid rate. participants requested ivf are asked to randomly culture equal numbers of oocyte and embryo with or without mva. therefore, sibling oocytes were randomly divided into test group and control group.

after being informed about the study and potential risks, all participants will write the informed contents. this study is a randomized controlled study co compare different treatment methods on the embryo development. sibling eggs were randomly divided into test group and control group. specific method of randomization: all the eggs of each subject were distributed into two dishes (dish 1 and dish 2). if the oocyte number is odd, put the extra oocyte into dish 1. using statistical software, the two dishes were randomly treated as test group and control group. thus, a random allocation table was generated and a separate random envelope was made for each subject. the random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher. each selected subject must open the random envelope. the subjects were subjected to routine ovulation promotion, and then the acquired oocytes and cumulus cell complexes (cocs) were obtained and fertilized in vitro. the test group oocytes were cultured with mva, while the control oocytes were cultured without mva. thus, half of the eggs from each elderly infertile patient were treated with mva.

Eligibility criteria:
inclusion criteria: 1. 38 years ≤ age ≤ 42 years; 2. number of ivf/icsi cycles ≤ 2 exclusion criteria: 1. egg donor cycle 2. chromosome abnormality; 3. adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases; 4. patients with repeated implantation failure
long-term follow-up study following treatment with fate therapeutics' engineered cellular immunotherapy

Conditions: Hematological Malignancy

Summary: the purpose of the study is to assess long-term side effects from subjects who receive a fate therapeutics genetically modified nk cell product. subjects who previously took part in a fate therapeutics study and received genetically changed nk cells will take part in this long-term follow-up study. subjects will join this study once they complete the parent interventional study. no additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. for a period of 15 years starting from the last administration of fate therapeutics genetically modified nk cell product, subjects will be assessed for long-term safety and survival through questionnaires and blood tests.

this is a non-therapeutic, multi-center, long-term follow-up (ltfu) study of subjects who received a fate therapeutics nk cell product that has been modified by lentivirus-mediated genetically engineering. the period of follow-up is 15 years after the administration of the nk cell product. the study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in fate therapeutics clinical studies. upon withdrawal or completion of the parent interventional study, the study site will contact the subject/healthcare provider/legal guardian annually.

Eligibility criteria:
inclusion criteria: * received engineered cellular immunotherapy in a fate therapeutics interventional study exclusion criteria: • not applicable
the evaluation of a nasal mask for the treatment of obstructive sleep apnea (osa): comfort & performance trial

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Summary: this investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the saturn mask amongst osa participants. an important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). a total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. a subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (cia-103). participants from previous nz trials may be recruited into this trial with their consent. all the participants will be recruited by wellsleep, wellington. participants will use the trial mask in home for a period of 7 ± 3 days. baseline data will be collected from the participant during the first visit, the prior 7 days of cpap usage data will be downloaded and stored for our analysis. the participant will use the trial device on their usual cpap/apap setting and device for the duration of the trial. this study will be conducted in accordance with ich/gcp guidelines. no deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. in such case, the deviation will be reported to the sponsor as soon as possible.


Eligibility criteria:
inclusion criteria: * adult (18+ years of age) * able to give consent * ahi ≥ 5 on diagnostic night * prescribed a cpap device after successful osa diagnosis * existing nasal or nasal pillow mask user exclusion criteria: * inability to give consent * participants who are in a coma or a decreased level of consciousness. * anatomical or physiological conditions making apap therapy inappropriate (e.g. unconsolidated facial structure) * commercial drivers who are investigated by new zealand transport agency (nzta) * current diagnosis of co2 retention * pregnant or may think they are pregnant.
troponin elevation after major noncardiac surgery 2

Conditions: Perioperative Myocardial Infarction; Disability; Perioperative/Postoperative Complications

Summary: major adverse cardiac events (mace) are a leading cause of mortality in patients undergoing noncardiac surgery. patients with perioperative myocardial injury (pmi), defined as either myocardial infarction and lower elevations in cardiac troponin, are also at substantially increased risk of additional cardiac and noncardiac complications. accordingly, it is plausible to assume that pmi negatively affects quality of life in terms of disability. the aim of this study is to investigate and compare the independent prognostic effects of the different pmi phenotypes (myocardial infarction and non-infarct troponin elevations) and noncardiac complications on disability in patients undergoing elective noncardiac surgery.


Eligibility criteria:
inclusion criteria: * ≥ 60 years old; * major noncardiac surgery defined as all noncardiac surgical procedures requiring an expected hospital stay of at least 24 hours; * elective surgery, defined as surgery that that has been preceded by a preoperative consultation at the anesthesia preoperative screening outpatient clinic. exclusion criteria: * patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in dutch or english). * patients with an american society of anesthesiologists (asa) physical status 5
a 3-year clinical evaluation of endocrown restorations with two different materials

Conditions: Endodontically Treated Teeth

Summary: the clinical performance of two different materials in endodontically treated teeth produced with cad/cam system will be evaluated and compared. after obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. all endocrown restorations will be produced using the same cad/cam system. 52 restorations will be fabricated using lava ultimate (lu, 3m espe, seefeld, germany) blocks and 38 restorations will be fabricated using celtra duo (cd, dentsply sirona, york, pa, usa) blocks. all restorative procedures will be conducted according to manufacturers' instructions. restorations will be scored using modified united states public health service (usphs) criteria after baseline, 6,12,36, 48, 60 months. descriptive statistics will be performed using chi-square and fisher exact test.


Eligibility criteria:
inclusion criteria: * good general health * patients older than 18 * teeth must receive endodontic therapy before restoration * the periodontal condition had to be stabilized before restoration * no subject complained of discomfort in teeth * radiograph revealing alveolar bone resorption of less than a third and no shadow around the periapical tissues * participants who provided writen informed consent were recruited in collaboration exclusion criteria: * any teeth with microcracks or fracture lines * affected teeth without completed root canal treatment * the defect was less than ¼ of crown or more than ¾ of the crown and the margin of the residual crown was more than 1 mm below the gingival level * poor oral hygiene and periodontal status which persisted or worsened after periodontal therapy and education * bruxism or clenching patients * poor general health or pregnancy * patients who have read the informed consent form and refused to be included in the study

Keywords: cad/cam endocrown resin nanoceramic zirconia-reinforced lithium silicate
a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ro7446603 administered alone or in combination with aflibercept or faricimab in participants with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study aims to evaluate the ocular and systemic safety, tolerability and efficacy of ro7446603 in participants with diabetic macular edema (dme). the study consists of 2 segments: phase i (parts 1-4) and phase ii (part 5). phase i investigated the safety of ro7446603 following a single and multiple intravitreal (ivt) doses as monotherapy or co-administered with ivt aflibercept or ivt faricimab (in separate injections). phase ii will investigate the safety, tolerability, pharmacokinetics (pk) and efficacy of two dose levels of ro7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single ivt injection, compared to faricimab alone. the first participant was enrolled in the phase i segment on june 22, 2022. phase i has been completed.


Eligibility criteria:
inclusion criteria: * documented diagnosis of diabetes mellitus (dm) (type 1 or type 2) with glycated hemoglobin (hba1c) \< 12% * macular thickening secondary to dme involving the center of the fovea \> 325 microns * decreased va attributable primarily to dme between 25 and 73 etdrs letters exclusion criteria: * currently untreated dm or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to day 1 * uncontrolled blood pressure (bp) * pregnancy or breastfeeding, or intention to become pregnant during the study * for parts 1-4: ivt anti-vegf treatment within 90 days prior to day 1; for part 5: ivt anti-vegf treatment within 120 days prior to day 1 or ivt anti-vegf treatment prior to day 1 for treatment naïve participants * treatment with susvimotm (ranibizumab injection) prior to day 1 * any ivt or periocular (sub-tenons) corticosteroid treatment within 6 months prior to day 1 * any current or history of ocular disease other than dme that may confound assessment of the macula or affect central vision * proliferative diabetic retinopathy (pdr) in the study eye * active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye other protocol-specified inclusion/exclusion criteria may apply
sport, rehabilitation and nutrition in multiple sclerosis: the linus project

Conditions: Multiple Sclerosis

Summary: only a limited percentage of persons with ms (pwms) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. the investigators reasoned that pwms should be more effectively prepared to increase their adherence. this study propose the implementation of an innovative collaborative approach, called "brief high-impact preparatory experience" (b-hipe), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwms. the aim of the study is the evaluation of its feasibility. for this pilot study the investigator chose a single-group design with repeated measurements at baseline and post intervention.


Eligibility criteria:
inclusion criteria: * aged 18 to 70 years * edss ranging from 1 to 7.5. * pwms with who are on a western diet * stabilized medical therapy and clinical conditions * pwms with a motor control of upper limbs sufficient to maneuver a tiller exclusion criteria: * heavy smoking, alcohol and drugs abuse * severe cognitive impairment * dysphagia and/or comorbidities requiring protected environments and specific medical assistance * blindness and severe visual disturbances (included severe nystagmus)

Keywords: lifestyle multiple sclerosis nutrition rehabilitation motivation adherence
identification and treatment of cervical abnormalities in perú through integration of pocket colposcopy and telemedicine

Conditions: Cervical Cancer; HPV Infection; HIV Infections

Summary: the pocket colposcope has 510k fda clearance and has been successfully used in almost 1500 unique patients globally in duke and non-duke protocols to date. the objective is to provide colposcopy capability to rural communities in peru potentially using telehealth. approximately 10,000 women will receive self hpv test kit for community health workers. of these participants, approximately 1,000 hpv+ participants will be invited to participate in this pocket colposcopy study. approximately 500 of these participants may require treatment using thermocoagulation.

the goal is to demonstrate that the combination of self-sampling, the pocket colposcope and the thermocoagulator will yield a high proportion of hpv positive women who complete treatment and follow-up care. the bulk of this trial will occur over a two-year period in peru. duke will provide the pocket colposcope and the calla application to run the device only. dr. garcia will recruit and train community women for the distribution of self-collection hpv test kits, identify and partner with 10 to 12 health centers in the andean region of peru, conduct baseline data collection in each health center, procure necessary equipment and technology, and conduct training for hpv testing, pocket colposcopy, and thermocoagulation. within 18 months trained community women will distribute 10,000 hpv tests to women within the region. the investigators anticipate that 10% of the women screened will be hpv positive and they will be recruited for our trial. as part of the study the participants will be followed to determine if the participants attend a health center, receive pocket colposcopy, and if needed whether the participants are treated with the thermocoagulator device. all women will be appointed to return to the health center for a follow-up evaluation six months post-treatment.

Eligibility criteria:
inclusion criteria: * hpv+ pap smear * women must between the ages of 30-49yo exclusion criteria: * hpv (-) pap smear * people without a cervix

Keywords: cervical cancer screening pap smear colposcopy
ct-based changes in bone and marrow among patients on oral steroids

Conditions: Asthma; Bone Density, Low; Oral Steroid-Dependent Asthma (Disorder)

Summary: the goal of this study is to assess the feasibility of emerging ct-based tools to measure changes in central and peripheral bone density, micro-structure, and marrow adipose tissue (mat) among patients treated with oral steroids.

this study aims to prove that emerging ct-based tools are suitable to measure changes in central and peripheral bone density, geometry, micro-structure, and marrow adipose tissue (mat) among patients treated with oral steroids. to do this, investigators will recruit 10 non-smokers (defined as \< 10 pack-year smoking history) age 25-45 years with a diagnosis of severe, persistent asthma who either chronically use oral steroids or do not use any oral steroids. participants will undergo dual-energy x-ray absorptiometry (dxa), dual-energy mid-tibia ct, high-resolution single-energy ankle ct, and low-radiation hip ct scans at baseline and 6-month follow-up visits. the images obtained will be used to analyze cross-sectional differences in central and peripheral bone density, geometry, micro-structure, and mat between patients using oral steroids versus those who do not use any oral steroids. differences in imaging at baseline and six-month follow visits will be used to analyze longitudinal bone changes among patients with oral steroid treatment.

Eligibility criteria:
inclusion criteria: * inclusion (all subjects): * diagnosis of severe, persistent asthma (defined as using both a long-acting beta-agonist and a high-dose inhaled steroid) * age 25-45 * inclusion (oral steroid group): * chronic treatment with oral steroids for at least 45 days but less than 1 year exclusion criteria: * exclusion (all subjects): * pregnant or breastfeeding * history of any cancer, excluding non-melanoma skin cancer * currently receiving dialysis * history of any lower extremity fracture * hip or knee replacement * non-ambulatory * greater than 10 pack-year smoking history * bmi \> 50 * age \ 45 * current or past use of fda-approved medication for osteoporosis: bisphosphonates (alendronate/fosamax, ibandronate/boniva, risedronate/actonel/atelvia, zoledronic acid/reclast) calcitonin (fortical, miacalcin) selective estrogen receptor modulator (raloxifene/evista) parathyroid hormone analogue (teriparatide/forteo) monoclonal antibody (denosumab/prolia)

Keywords: glucocorticoid corticosteroid
combination of telmisartan 40 mg plus hydrochlorothiazide (hctz) 12.5 mg vs. telmisartan 40 mg alone in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy

Conditions: Hypertension

Summary: the objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg and hctz 12.5 mg is superior to the monocomponent of telmisartan (micardis, gliosartan, kinzal, kinzalmono, predxal, pritor, samertan, telmisartan) 40 mg in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy.

this is a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel-group study in patients with essential hypertension who fail to respond adequately to telmisartan (micardis) 40 mg monotherapy. after a screening and a 2-week washout period (screening period), the patients will enter 4-week open-label run-in period with telmisartan (micardis) 40 mg monotherapy to assess eligibility. the study will be terminated for those who have responded to telmisartan (micardis) 40 mg monotherapy at the end of 4-week open-label run-in period with telmisartan (micardis) 40 mg monotherapy (mean seated dbp \< 90 mmhg). about 200 patients not responding adequately to telmisartan (micardis) 40 mg monotherapy will be randomised and treated for 8 weeks with once-daily administration of either telmisartan (micardis) 40 mg or a fixed dose combination of telmisartan 40 mg and hctz 12.5 mg (double-blind treatment period). study hypothesis: the hypothesis is that the fixed dose combination of telmisartan 40 mg and hctz 12.5 mg is superior to the monocomponent of telmisartan (micardis) 40 mg in pat ient with essential hypertension who fail to respond adequately to telmisartan monotherapy. comparison(s): for the primary comparison the change from baseline in mean stated trough dbp at the end of the 8-week double-blind treatment will be expressed.

Eligibility criteria:
inclusion criteria: * essential hypertensive patients who meet all the criteria as follows: * mean seated dbp must be \>= 95 and \<= 114 mmhg at visit 2 * mean seated sbp must be \>= 140 and \<= 200 mmhg at visit 2 * mean seated dbp must be \>= 90 and \<= 114 mmhg at visit 3 * mean seated sbp must be \<= 200 mmhg at visit 3 exclusion criteria: * patients taking 4 or more anti-hypertensive medications at visit 1 * patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.)