Kornimate/medical-research-clean huggingface dataset:
ambulatory cpap titration in moderate obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: the aim of this trial is to compare two different ways of cpap titration: cap titration with fixed pressure vs. auto-titrating cpap.

continuous positive airway pressure (cpap) for the treatment of moderate obstructive sleep apnea (osa) is only reimbursed in belgium after in-laboratory overnight titration. nevertheless, in a recent clinical practice guideline of the aasm, it is recommended that pap therapy can be initiated using either in-laboratory titration or auto-titrating cpap (apap) at home in osa patients without significant comorbidities. indeed, several studies evaluated the impact of titration with apap at home in these patients and showed that the outcome is comparable with in-hospital titration. up to now, evidence for home titration with fixed cpap (and follow-up via telemonitoring) is very limited. the use of sleep laboratory space is costly and limits access for diagnostic studies. this study aims to evaluate whether cpap titration at home with fixed cpap produces outcomes equal to those following apap titration.

Eligibility criteria:
inclusion criteria: * moderate osa (obstructive ahi 15-30/u on initial psg) exclusion criteria: * presence of hypoventilation * presence of central sleep apnea (central ahi ≥ 15)
screening for alcohol-related cognitive impairments in cirrhotic patients

Conditions: Alcohol Dependence; Dependence; Cognitive Impairments; Cirrhosis; Liver Diseases

Summary: 80% of patients with alcohol use disorders (aud) present cognitive impairments, such as memory and executive functions. these disorders may have repercussions in addiction treatment by altering the patient's adherence to care. the level of impairment is dependent on the onset of addiction, and also the duration of abstinence. a complete neuropsychological evaluation is necessary to highlight cognitive impairments. in practice, the evaluation of these disorders by practitioners, is done with the help of tools of screening like the moca (montreal cognitive assesment) and the bearni (brief evaluation of alcohol related neuropsychological impairment). however, none of these tools have been evaluated in patients with alcoholic cirrhosis. indeed, some studies have suggested that liver disorders including cirrhosis may be a factor aggravating cognitive disorders. the purpose of this study is to evaluate the ability of the bearni tool to detect alcohol-related cognitive problems in patients with alcohol-related cirrhosis.


Eligibility criteria:
inclusion criteria: * patient with cirrhosis * patients with cirrhosis diagnosed by clinical examination * patients with cirrhosis diagnosed by biological and / or morphological and / or noninvasive tests and / or liver biopsy * child a, b or c exclusion criteria: * hepatitis encephalopathy less than 6 months old * complicated cirrhosis with hepatocellular carcinoma * acute alcoholic hepatitis * viral cirrhosis

Keywords: alcohol dependence dependence cognitive impairments cirrhosis liver diseases
intraoperative clonidine for postoperative pain management in patients undergoing surgical treatment for endometriosis

Conditions: Endometriosis; Postoperative Pain; Pain, Acute; Pain, Acute Postoperative

Summary: the role of a single dose of intraoperative clonidine on postoperative opioid requirements, pain intensity and opioid-related side effects in patients undergoing surgical treatment for endometriosis remains scarcely explored. a prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative clonidine in patients undergoing surgical treatment for endometriosis is therefore conducted.

background with aim: acute postoperative pain is a major and common concern for the large number of patients who undergo surgery each year. despite advances in pain management strategies, many patients continue to suffer from moderate-to-severe pain during the early postoperative period. this is concerning as unrelieved pain can result in decreased patient satisfaction, increased morbidity, prolonged hospital length-of-stay and increased risk of persistent pain. effective treatment of acute postoperative pain should therefore be prioritized. opioid analgesics remain the mainstay treatment for postoperative pain. the potential benefits of opioid therapy for acute pain are short-term pain control. however, there are several potential harms associated with opioid use which may outweigh the benefits including sedation, nausea, vomiting, constipation and risk of long-term use. in this respect, a single dose of clonidine could provide stable analgesia and potentially reduce the need for shorter-acting opioids. therefore, the investigators decided to carry out the present study with the aim to examine the analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption, pain intensity and opioid-related side effects. method: 120 patients undergoing surgical treatment for endometriosis will be included in this prospective, randomized, double-blind, controlled trial with two arms: an intervention arm (clonidine 150 microgram) and a control arm (isotonic saline). the study will be gcp-monitored, and is approved by the danish medicines agency (2022064017) and the national committee on health research ethics (2209269). hypothesis: the investigators hypothesize that a single dose of intraoperatively administered intravenous clonidine will be effective in reducing postoperative opioid requirements, pain intensity and opioid-related side effects.

Eligibility criteria:
inclusion criteria: • patients scheduled for surgical laparoscopic treatment of endometriosis at aarhus university hospital exclusion criteria: * age \< 18 years * american society of anesthesiologists (asa) physical status iv or v * allergy to clonidine * inability to provide informed consent * known severe renal insufficiency * known severe bradyarrhythmia * pregnancy, lactation: * daily opioid consumption the last 7 days before surgery * pain intensity \>5 on more than half of the days during the last month
intensive insulin treatment and ischemic foot ulcer

Conditions: Ischemic Foot Ulcer

Summary: we aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ict) compared to standard insulin treatment (st).

the stockholm diabetes intervention study (sdis) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomiz (october 1982 to march 1984) to intensified conventional treatment (ict; n=48) or standard treatment (st; n=54). the randomized sdis study lasted for 7.5 years, whereas 96 patients were fully evaluated. thereafter patients were assigned to their regular clinical visits. in the present study, 96 patients from the sdis study were asked to participate in current study and to investigate their skin microcirculation, in which 72 patients agreed (ict; n=35 vs. st; n=37). also, nineteen healthy subjects participated as controls for the method of iontophoresis, with no intention to be followed-up. exclusions criteria were; any history or ongoing ischemic foot ulcer or peripheral artery disease or osteoartropathy. the iontophoresis investigation took place 5.5 years ± 2 months, after the primary randomization ceased (7.5 years). all participants (except the control subjects) were then followed-up until first time hospitalization for ischemic foot ulcer or until 31 december 2011.

Eligibility criteria:
inclusion criteria: born 1930 or later, type 1 diabetes appearing at age 30 or earlier and with insulin dependency within 1 year from diagnosis, no known abuse of alcohol or drugs, non-prolipherative retinopathy of any degree present, no previous photocoagulation, normal serum creatinine, unsatsifactory blood glucose control according to the physician in charge of the patients. exclusion criteria: any history or ongoing ischemic foot ulcer,or peripheral artery disease,or osteoartropathy.

Keywords: hba1c iontophoresis intensified insulin treatment ischemic foot ulcer type 1 diabetes
computerized intervention of parental involvement in diabetes care of their child

Conditions: Diabetes

Summary: the purpose of this study is to develop an intervention to increase parental motivation for supervision and monitoring youth diabetes care behavior. the intervention will be tested in three brief session in conjunction with regularly scheduled diabetes clinic visits and delivered through a computer program based in the principles of motivational interviewing.

the study includes a development phase (phase 1: development of the intervention followed by feasibility testing with 10 youth and 10 parents) and a pilot validation phase \[phase 2: pilot randomized clinical trial (rct)\] using a sample of 90 african american youth transitioning to independent diabetes care and their parents. in this phase, families will be randomly assigned to one of three study arms: parent motivation for monitoring and youth motivation for diabetes care (arm 1), parent motivation for monitoring and youth information (arm 2) or parent and youth information (arm 3). in phase 1 (development), youth and their caregivers will complete a one-time research visit where they use the program and provide feedback via a semi-structured interview regarding the usefulness of the content, its user-friendliness and make suggestions for changes to enhance acceptability. in phase 2 ( rct), families will complete three intervention plus data collection visits and one additional data collection only visit. research visits will be scheduled to coincide with appointments in the diabetes clinic to maximize convenience for families.

Eligibility criteria:
inclusion criteria: * african american race/ethnicity * age: 10 years 0 months - 12 years, 11 months * type 1 diabetes mellitus * diagnosed at least 6 months * patient of children's hospital of michigan diabetes clinics * english fluency, both verbal and written exclusion criteria: * psychiatry/psychological diagnoses including cognitive impairment that would prevent the participant from understanding the data collection measures, (i.e. moderate or severe mental retardation) or the following psychiatric diagnoses: autism and schizophrenia. youth with current suicidal intent are not enrolled until psychiatrically stable. * medical diagnoses that would result in atypical diabetes management i.e. cystic fibrosis. other medical conditions that would not affect diabetes management, such as asthma, do not exclude the participant from study participation.

Keywords: parenting parental monitoring diabetes care
car-t therapy in relapsed or refractory haematopoietic and lymphoid malignancies

Conditions: Leukemia; Lymphoma

Summary: this is an open, single-arm, phase i clinical study to evaluate efficacy and safety of chimeric antigen receptor t cell immunotherapy (car-t) in the treatment of hematopoietic and lymphoid malignancies. a total of 30 patients are planned to be enrolled over a period of 2 years.

chimeric antigen receptor (car)-modified t cells targeted against cd19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. besides cd19, many other molecules such as cd22, cd30, cd7, bcma, cd123, etc. may be potential in developing the corresponding car-t cells to treat patients whose tumors expressing those markers. investigators have developed a high efficient platform for constructing different cars and preclinical studies have demonstrated effective killing of corresponding target cells. in this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. the primary goal is safety assessment including cytokine storm response and any other adverse effects. in addition, tumor targeting and disease status after treatment will also be evaluated.

Eligibility criteria:
inclusion criteria: 1.the treat history meeting the following criteria: 1. recurrence of lymphoma patients with imaging (ct/mri/pet-ct) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the mrd recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; 2. can't get complete remission (including mrd positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; 3. one or twice chemotherapy cannot get remission again (including mrd positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients. 2. there is a measurable lesions before treatment at least; 3. ecog score≤2; 4. to be aged 1 to 70 years; 5. more than a month lifetime from the consent signing date exclusion criteria: 1. serious cardiac insufficiency, left ventricular ejection fraction\<50; 2. has a history of severe pulmonary function damaging; 3. merging other malignant tumor; 4. merging uncontrolled infection; 5. merging the metabolic diseases (except diabetes); 6. merging severe autoimmune diseases or immunodeficiency disease; 7. patients with active hepatitis b or hepatitis c; 8. patients with hiv infection; 9. has a history of serious allergies on biological products (including antibiotics); 10. happened in 3 \~ 4 acute gvhd after allogeneic hematopoietic stem cell transplantation on recurring patients 11. pregnancy or lactation women; 12. any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
analysis of hematoma following breast surgery

Conditions: Hematoma; Postoperative Bleeding

Summary: a retrospective review of patients who developed hematoma following breast surgery from 2003 to 2018 in a single institution was performed. the study investigated the value of closed-suction drains regarding the quantity and quality of fluid secretion for the prediction of subcutaneous hematoma in patients undergoing breast surgery procedures.


Eligibility criteria:
inclusion criteria: * patients who developed hematoma requiring revision following bilateral breast surgery including augmentation mammoplasty, subcutaneous mastectomy and breast reduction. exclusion criteria: * patients who developed hematoma requiring revision following unilateral breast surgery. * breast surgery in absence of hematoma. * patients with known coagulation disorders.

Keywords: breast surgery closed-suction drains
efficacy and safety of brimonidine tartrate ophthalmic solution in adult and geriatric participants with ocular redness

Conditions: Hyperemia

Summary: to compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.


Eligibility criteria:
inclusion criteria: * at least 18 years of age. * have a history of redness relief drops use or expressed a desire to use drops for redness relief, within the last 6 months. * have ocular health within normal limits including a calculated best-corrected visual acuity of 0.3 logarithm of the minimum angle of resolution (logmar) or better in each eye, as measured using an early treatment diabetic retinopathy study (etdrs) chart. exclusion criteria: * any ocular/systemic health problems. * use of any disallowed medications.

Keywords: ocular redness
deanxit and rivotril in tinnitus patients

Conditions: Tinnitus

Summary: the purpose of this study is to investigate whether increased tinnitus reduction can be obtained with deanxit in patients already receiving rivotril.


Eligibility criteria:
inclusion criteria: * pure tone, narrow band noise or polyphonic tinnitus * unilateral or bilateral tinnitus * vas ≥ 4 * cochleair origin tinnitus * tinnitus present 3 months or more * age 18y or more * intake rivotril 1mg/d * patient 'able to cooperate' * patient able to fill in tq en vas * no pontine angle pathology on mri exclusion criteria: * pulsatile tinnitus * pregnancy or breast feeding * contra-indications deanxit * recovery myocard infarct * conduction disorder his * untreated glaucoma * mao inhibitors: 15d stop * otosclerosis * middle ear pathologies * ménière * somatic tinnitus

Keywords: tinnitus
intravitreal ranibizumab for the prevention of radiation maculopathy following plaque radiotherapy

Conditions: Uveal Melanoma; Radiation Retinopathy; Radiation Maculopathy

Summary: uveal melanoma is the most common primary intraocular malignancy in adulthood. eye preserving treatments can deliver equivalent life prognosis in the management of small and medium sized uveal melanomas, as compared to enucleation. plaque radiotherapy has emerged as the most common eye-preserving treatment in the current management of uveal melanoma, but is complicated by visual loss in approximately 70% of patients at 10 years follow-up. strategies for the prevention and early treatment of radiation retinopathy/maculopathy need to be developed to improve visual outcomes following plaque treatment. ranibizumab (lucentis) is the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits the activity of vascular endothelial growth factor a, a mediator in the development of choroidal neovascularization. lucentis is commonly used in the eye for eye conditions such as age related macular degeneration. this study will investigate the possible benefit of anti-vegf therapy (lucentis) in reducing the incidence of radiation complications following plaque radiation for uveal melanoma.


Eligibility criteria:
inclusion criteria: * age \>18 years * new diagnosis of choroidal melanoma * scheduled for plaque radiotherapy at wills eye health system exclusion criteria: * pre-existing retinal disorders (i.e. age-related macular degeneration, diabetic maculopathy, retinal vascular occlusion, macular hole, surface wrinkling retinopathy) * prior retinal detachment * media opacities precluding accurate oct imaging * history of glaucoma * pregnancy * age \<18 years.
a study to investigate the immunogenicity and safety of mrna-1345 vaccine targeting respiratory syncytial virus (rsv) in high-risk adults

Conditions: Respiratory Syncytial Virus

Summary: the study is divided into 2 parts (part a and part b). part a of the study will evaluate the safety and immune response to mrna-1345 in high-risk adults aged ≥18 to \<60 years. part b of the study will evaluate the safety and immune response to mrna-1345 in adults who received solid organ transplant (sot).


Eligibility criteria:
key inclusion criteria: part a: * adults ≥18 to \<60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living. * documented confirmation by a physician of the diagnosis of at least one of the following conditions: 1. coronary artery disease and/or congestive heart failure. 2. chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma). 3. stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to day 1. part b: * adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living. * recipient of an sot (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection. parts a and b: - able to comply with study requirements. key exclusion criteria: part a: * participation in an another clinical research trial where the participant has received an investigational product 180 days prior to day 1. participation in an rsv trial at any time prior to day 1 is exclusionary. * history of a diagnosis or condition, that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. * reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mrna-1345 injection or any components of the mrna-1345 injection. * chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 180 days prior to day 1. * history of myocarditis, pericarditis, or myopericarditis. part b: * previous treatment with alemtuzumab or rituximab within 2 years prior to day 1. * previous treatment with plasmapheresis within 30 days prior to day 1. * a history of complications of immunosuppression. * a history of biopsy proven or clinically diagnosed rejection within 90 days prior to day 1 or suspected active chronic rejection according to the investigator's judgment. note: other protocol-defined inclusion/exclusion criteria apply

Keywords: viral diseases messenger rna moderna mrna-1345 respiratory syncytial virus safety vaccines immunocompromised organ transplant
gynaecological care for transgender people in france in 2024.

Conditions: Transgender Management Care

Summary: to date, the transgender population, still poorly characterized, tends to increase. the impact of gender-affirming hormone therapy (gaht) in this population remains poorly understood, and few data are published on the gynecological repercussions of such therapy. a recent literature review by a french team suggests gynecological follow-up procedures for transgender people.

the hypothesis of this study is that transgender population in france does not have appropriate gynecological care, and the study would like to find out, directly from the people concerned, the current state of gynecological care for transgender people in france. to do this, ths study plan to send out a questionnaire to transgender people (via healthcare networks and also transgender associations) to ask them about their actual gynecological care and their knowledge of recommended gynecological care. the aim is to set up a descriptive, declarative study based on a questionnaire created specifically for this work. this project will use a questionnaire for transwomen people and another one for transmen people. transgender people will be approached via trans associations and healthcare networks. an online link to the questionnaire will be sent to trans associations and healthcare networks for distribution to the target population thanks to a flyer.

Eligibility criteria:
inclusion criteria: * french-speaking transgender person (transgender women or transgender men) * age ≥18 years exclusion criteria: * age \<18 years

Keywords: gynaecology gender-affirming hormonal therapy breast cancer transgender contraception