Kornimate/medical-research-clean huggingface dataset:
culturally adapted intervention to prevent self-harm in young people with autism

Conditions: Autism Spectrum Disorder; Self Harm

Summary: the goal of this feasibility randomized controlled trial is to assess the feasibility and acceptability of youth culturally adapted manually assisted brief psychological intervention (ycmap) in young people with autism in pakistan. in a rater-blind, 2-arm, multi-site, feasibility randomized controlled trial (rct), participants will be randomized either to 1) ycmap added to the treatment as usual (tau) or 2) tau alone. participants in the y-cmap arm will receive 8-10 sessions delivered individually over 3 months (weekly for 1 month then fortnightly), lasting for 60 minutes. assessments will be conducted at baseline and at 3 months.


Eligibility criteria:
inclusion criteria: * aged 18-24 years * history of self-harm and/or possible suicidal behavior * able to engage in assessment and intervention * ability to provide informed consent exclusion criteria: * young people with autism with limited receptive and expressive language skills that would prevent engagement * with any chronic medical disorder or physical condition (including communicable diseases such as tuberculosis) that would prevent participation in assessments and or intervention. * not willing to participate.

Keywords: autism self harm youth suicidality
consolidation treatment with y90-ibritumomab tiuxetan after r-chop induction in high risk patients according to follicular lymphoma international prognostic index (flipi) with follicular lymphoma

Conditions: Follicular Lymphoma

Summary: to evaluate the complete clinical response rate according to the international working group criteria with a consolidation treatment with 90y-ibritumomab tiuxetan (zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to r-chop induction chemotherapy


Eligibility criteria:
inclusion criteria: * signature of the written informed consent by the subject or his/her legal representative before initiation of any trial specific procedure. * patients older than 18. * histologic diagnosis of cd20+, grade 1-3a follicular lymphoma as per the who classification. * high-risk patients according to flipi before initiation of induction chemotherapy. * stage ii-iv prior to initiation of induction treatment, or any stage in patients with grade 3 follicular lymphoma. * complete or partial response to the induction scheme. * ecog scale performance status 0 - 2. * life expectancy greater than 3 months. * in women of childbearing age, use of a reliable contraceptive method. * a suitable bone marrow reserve: * lower than 25% bone marrow infiltration by lymphoma. * hb 10 g/dl. pmn leukocytes 1,500 cel/mm3, platelets 100,000/mm3 * suitable hepatic, renal and cardiac function: * creatinine \<2,5 x unl (upper normality limit). * bilirubin or alt/ast \< 2,5 x unl exclusion criteria: * patients with no objective clinical response to induction chemotherapy. * \> 25% bone marrow infiltration following induction chemotherapy. * platelets \< 100,000 before radioimmunotherapy. * severe and/or uncontrolled concomitant disease: * hepatic, renal, cardiovascular, neurological or metabolic disease. * cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of myocardial infarction or angor, or major ventricular arrhythmia. * positive regarding hbv, hcv, hiv. * active acute or chronic infection. * social, psychic or geographic disability to satisfy any of the treatment schemes. * pregnant and/or breastfeeding women, or adult patients of childbearing age who are not using a safe birth control device throughout the study treatment and at least 12 months thereafter. * known or suspected hypersensitivity, or confirmed or suspected adverse reaction to the study drugs and other related compounds (rituximab, ibritumomab tiuxetan, a history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other anthracyclines, cytarabine).

Keywords: follicular lymphoma high-risk flipi r-chop gotel partial complete response induction chemotherapy
pain relief after corneal collagen cross-linking

Conditions: Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXL

Summary: keratoconus is a progressive corneal ectasia that can lead to significant visual impairment and decreased quality of life. the introduction of corneal cross-linking (cxl) with riboflavin and ultraviolet-a (uva) light has revolutionized the treatment of keratoconus by increasing corneal rigidity and arresting disease progression. the epithelium-off protocol, which induces heightened post-surgical discomfort, is the prevailing approach. despite the success of cxl, postoperative pain is a common side effect that can negatively impact patients' quality of life and impede recovery. pain management after cxl is essential for optimizing patient outcomes and satisfaction. systemic painkillers, though not researched enough, may potentially aid in healing and recovery, minimizing complications and discomfort for the patient. in this study we will provide evidence-based recommendations for clinicians to optimize pain control after cxl in collaboration with pain specialists.


Eligibility criteria:
inclusion criteria: * patients above the age of 15 years * patients who are undergoing cxl treatment exclusion criteria: * renal and/or hepatic failure * patients under the age of 15
diagnostic cervical conization for persistent infection or integration of hpv

Conditions: Human Papilloma Virus Infection; Human Papilloma Virus Integration; Cervical Intraepithelial Neoplasia; Cervical Cancer; Cervical Conization

Summary: for the patients with cervical persistent infection or integration of hpv, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of hpv infection and related cervical intraepithelial neoplasia/cancer.

for the patients with cervical persistent infection or integration of human papillomavirus, the incidence of suffering cervical cancer or percancerous lesions increases. as the biopsy guided by colposcopy might miss some lesions, the cervical conization plays a role for the patients with high risk factors to diagnose the related cervical diseases. in this study, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of hpv infection and related cervical intraepithelial neoplasia/cancer.

Eligibility criteria:
inclusion criteria: 1. the patients are referred to colposcopy and biopsy examinations due to abnormal cervical screening results with no precancerous lesions discovered by pathology. 2. the cervical precancerous lesions are highly suspected by clinicians with one or more following risk factors: * the course of hpv type 16/18 persistent infection is more than two years. * the integration reads of hpv is more than 15. * the impression of colposcopy indicates precancerous lesions. * the cervical tct indicates asc-h/hsil/scc/agc-fn/ais/ac. exclusion criteria: 1. pregnant women. 2. vaginal intraepithelial neoplasia is highly suspected by colposcopy and pathological examinations. 3. the patients are suffering malignant tumors of other system and have not been cured. 4. there is acute inflammation of the lower genital or anal tract. 5. the patients' health will be severely harmed by the colposcopy and cervical conization due to some circumstances such as severe insufficiency of liver and kidney function, blood diseases and acute inflammation of other systems.

Keywords: hpv persistent infection hpv integration diagnostic cervical conization
phase 2 trial to evaluate belzupacap sarotalocan (au-011) via suprachoroidal administration in subjects with primary indeterminate lesions and small choroidal melanoma

Conditions: Uveal Melanoma; Ocular Melanoma; Choroidal Melanoma

Summary: the primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (il/cm).

this is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (il/cm) * have no evidence of metastatic disease confirmed by imaging * be treatment naïve for il/cm exclusion criteria: * have known contraindications or sensitivities to the study drug or laser * active ocular disease

Keywords: uveal melanoma eye cancer ocular melanoma choroidal melanoma
vitamin d supplementation for extremely preterm infants

Conditions: Vitamin D Deficiency; Preterm Infants; Bronchopulmonary Dysplasia

Summary: the study hypothesis states that giving early enteral vitamin d supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.

after informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. clinicians, researcher, and primary caregivers will be masked. subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control. early vitamin d supplementation/placebo will be initiated within the first 7 days after birth. premature infants will be randomized to receive one of the 3 fixed doses of vitamin d: either placebo (zero dose), 200 iu/day, or 800 iu/day. the supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. after this period of supplementation, routine supplementation will be conducted in all groups. remnant cord blood samples will be analyzed for vitamin d levels (serum hydroxyvitamin d \[25(oh)d\]. two circulating vitamin d concentrations (25(oh)d concentrations) will be measured on postnatal days 14 and 28. urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found. supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (oh)d concentrations \>60ng/ml (\>150nmol/l; potentially toxic) are detected or, if infant npo for greater than 24 hours. if infant made briefly npo (\<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant pda, or respiratory difficulties, enteral vitamin d will not be discontinued. all infants will be followed to discharge for primary, secondary outcomes as well as adverse events.

Eligibility criteria:
inclusion criteria: * infants admitted to the regional newborn icu of the university of alabama with gestational age between 23-27 completed weeks exclusion criteria: * major congenital/chromosomal anomalies * moribund infant with low likelihood of survival, in opinion of the clinical team

Keywords: vitamin d newborn preterm supplementation respiratory
laparoscopic narrow band imaging for detection of occult cancer metastases

Conditions: Gastrointestinal and Gynecologic Malignancies

Summary: adult patients evaluated at lahey clinic with known or suspected gastrointestinal or gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered participation in the study. the proposed study is a randomized, controlled feasibility trial with crossover design. the study's aim is to evaluate the effectiveness of laparoscopic narrow band imaging (nbi) compared to standard white-light laparoscopy for detection of peritoneal cancer metastases. study patients will undergo laparoscopic evaluation of the peritoneal cavity using a routine white-light videolaparoscope with the capability of nbi. the order of white-light and nbi laparoscopy will be randomized for each patient (crossover design). frozen-section histopathology biopsies will be retrieved of all suspicious-appearing abnormalities using best clinical practices. the number of detected peritoneal metastases will be compared between each diagnostic laparoscopy technique. to gauge the rate of potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year follow-up.


Eligibility criteria:
inclusion criteria: * adult patients * diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract exclusion criteria: * clinical contraindication to diagnostic laparoscopy
dietary flaxseed in nsclc

Conditions: Lung Cancer

Summary: this single arm phase ii trial will investigate the feasibility of dietary flaxseed (fs) supplementation in subjects receiving definitive chemoradiotherapy for non-small cell lung cancer (nsclc). subjects will ingest fs for a period of approximately 8 to 9 weeks during the course of radiation treatment. study participation and surveillance will last approximately 6 months. subject specimen collection will include: blood, urine, and buccal swabs at 5 time points.


Eligibility criteria:
inclusion criteria: * male or female, ages 18 and older * current diagnosis of non-small cell lung cancer (nsclc) including patients who have metastatic disease requiring definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy. * able to provide written informed consent and comply with all study procedures * total planned radiation dose to gross disease 60-70 gy. exclusion criteria: * current diagnosis of disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrostomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) * known hypersensitivity to flaxseed or any of its metabolites, or wheat products * taking or has taken an investigational drug within 14 days. * taking or has taken amifostine or mucomyst (n-acetylcysteine) within 14 days * current or prior use of flaxseed, flax-containing products, soybeans, or soy-containing products * current or prior use (limited to prior 14 days) of dietary supplements such as herbals or botanicals * prior thoracic and/or mediastinal radiation therapy
cervical restorations placed under two isolation methods

Conditions: Non-carious Cervical Lesions

Summary: during restorative procedures, different isolation methods of the operative field can be used to promote moisture control and retraction of the gingival tissues. the aim of the present clinical trial is to evaluate the effects of two isolation techniques on the clinical performance of class v restorations, as well on the periodontal conditions of restored sites. patients presenting at least two noncarious cervical lesions (ncls) will be enrolled in this study. the ncls will be randomized into the following groups: (1) isolation performed with rubber dam and gingival retraction clamp and (2) isolation provided with cotton rolls and gingival retraction cord. both techniques will be used with a saliva suction device. all restorative procedures were performed using a self-etching adhesive system and a nanofilled composite resin according to the manufacturer's instructions. the clinical performance of restorations will be recorded in terms of fracture and retention of restoration, marginal adaptation, marginal staining, postoperative hypersensitivity, and preservation of tooth vitality at 1 week, 6 months, 12, 24 and 72 months after placement. the periodontal condition of restored sites will be evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.


Eligibility criteria:
inclusion criteria: * more than one cervical lesion * lesions whose apical limit located above the gingival margin * lesions with at least 1 mm of depth * vital permanent incisors, canines, or premolars exclusion criteria: * smoking habits * severe systemic diseases * active orthodontic treatment * malocclusion (angle class ii or class iii) * less than 20 natural teeth in mouth * absent of antagonist tooth * wear facets over more than 50% of the incisal/occlusion surface as a result of tooth attrition * or restorations in the area to be treated * full-mouth visible plaque index (vpi) or full-mouth gingival bleeding index (gbi) more than 20% * probing depth (pd) and clinical attachment loss (cal) values exceeding 4 mm with bleeding on probing (bop) * unwillingness to return for follow-ups or refuse to participate

Keywords: adhesives. composites. noncarious cervical lesions. clinical performance. treatment
dental study in cancer patients with central venous catheters

Conditions: Cancer

Summary: patients who are preparing to receive chemotherapy are asked to have their teeth cleaned before starting treatment as standard of care. this research study is being done to see if having dental cleaning increases the chances of bacteria from the mouth getting into the blood stream. it is also being done to see if these bacteria can cause blood stream infections in people who have a central venous catheter (cvc),often called a "port" or a "picc", placed for giving chemotherapy. it is a well-established fact that we introduce bacteria from the mouth into the bloodstream with activities of daily life including chewing, flossing and brushing teeth. this introduction of bacteria into the blood stream may cause bacteria to stick to the central venous catheter and serve as a source of infection when the immune system is weakened by cancer. the purpose of this research study is to see if we can find bacteria from mouth in blood that is drawn through the cvc, during, and after a dental cleaning procedure. this way, we will be able to assess whether or not this is a potential health risk to cancer patients.


Eligibility criteria:
inclusion criteria * patients willing and able to provide written informed consent for the study. * patients diagnosed with cancer and being treated at the university of connecticut health center. * patients scheduled to receive or who have received a central venous catheter * patients who have at least one tooth. exclusion criteria * patients under the age of 18 * patients who have received any antibacterial in the time period starting 48 hours before the dental cleaning. this includes systemic antibacterials and topical antibacterials in the oral cavity or at/through the cvc site. (topical antibacterials at other sites are allowed; antifungal and antiviral agents in any form are allowed). * patients who plan to use antibacterials within the 24 hours after the procedure (until the final blood sample is obtained). * patients with a documented blood stream infection within 1 month prior to proposed dental cleaning. * patients with a clinically significant coagulation disorder or patients on warfarin. * patients who require antibiotic prophylaxis as per american college of cardiology/american heart association (acc/aha) 2007 guidelines, namely; * patients who have had a cardiac transplantation, * incomplete cardiac valve repair, * complete cardiac valve repair in last 6 months, * prior history of infective endocarditis , * patients with a prosthetic cardiac valve. * patients with any other condition which might preclude participation in the opinion of the patient's physician(s) or the study pi's.

Keywords: cancer blood stream infections bacteremia dental procedure central venous catheters mediport picc line
observational evaluation of infective risk in myelodysplastic syndrome patients

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to observe the number of new cases of infections per population in a given time period and their characteristics in a pathology (myelodysplastic syndrome, mds)that involves ineffective production (or dysplasia) of a class of blood cells.

the scarcity and the inadequacy of data make impossible the writing of evidence-based recommendations for prevention and management of infections in myelodysplastic syndrome. the aim of this study is to evaluate the incidence and the spectrum of the infections of mds patients. will be also evaluated potential risk factors. this study could help the definition of the optimal management of mds patients in terms of prophylaxis of the infective complications and in terms of the correct administration of growth factors.

Eligibility criteria:
inclusion criteria: * all adult patients (\>18 years) with newly diagnosed myelodysplastic syndrome or patients who have undergone a bone marrow reevaluation; * signed written informed consent; exclusion criteria: * psychiatric patients; * patients with life expectancy less than three months.

Keywords: adult patients infective events antibiotic antifungal myelodysplastic syndrome
immersive care - virtual reality(vr) 360 pediatric surgery preparation.

Conditions: Surgery

Summary: context: this study is part of the larger immersive care project which (in short) seeks the connection between technology and care by conducting feasibility studies with promising technological interventions tailored to care. this is one of the case studies from the larger project titled: 360 ° video vr surgery preparation: feasibility, acceptability, tolerability and initial effectiveness of virtual reality for children in a flemish hospital. domain: this scientific study will take place in 1 hospital on the pediatric ward. the target group consists of children between 6 and 12 years of age who will undergo an operation, the parents and the care providers involved. target: 1. assess the acceptability, feasibility and tolerability of the 360 ° video vr surgery preparation. 2. assess the effectiveness of the 360 ° video vr surgery preparation on preoperative procedural anxiety in children, comparing the intervention with care as usual (cau \*). * cau in this study is a picture book which is a kind of animated video with text to explain what will happen on the day of the operation.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained * inpatient or outpatient in the study site (heilig hart hospital lier): each paediatric patient who will undergo surgery during the study period (01-12-2020 and 30-09- 2021). * age range of ≥ 6 and ≤ 12 * normal or corrected-to-normal vision * normal or corrected-to-normal hearing exclusion criteria: * patient has a history of seizure disorders (e.g. epilepsy) * physical impairment that preclude vr intervention (e.g. facial burns or wounds, contagious infectious disease, need for intensive care) * non-dutch/english/french speaker: both the paediatric patient and his/her caregiver must be able to provide informed consent and assent * previous enrolment in this study (during a previous hospital stay)

Keywords: pediatrics preparation virtual reality 360 video anxiety