Kornimate/medical-research-clean huggingface dataset:
pd p 506 a-pdt versus placebo-pdt and cryosurgery for the treatment of ak

Conditions: Actinic Keratosis

Summary: the aim of this study is to investigate how the efficacy and tolerability of pd p 506 a-pdt relate to the commonly used cryosurgery in the treatment of mild to moderate ak lesions located on the head. to be able to quantify the effect the patient will be allocated to one of three treatments: pd p 506 a-pdt, cryosurgery or placebo-pdt.

actinic keratosis (ak) is a pre-cancerous skin abnormality usually caused by sun exposure. actinic keratoses occur most commonly in fair skin, especially in the elderly. they mainly occur in sun-exposed skin areas like head and hands. it is standard of care to remove ak when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (pdt). in europe, cryosurgery is the method primarily used and will therefore serve as comparator therapy for pd p 506 a-pdt. a placebo control will be necessary to validate the test system. while the comparison of pd p 506 a-pdt and cryosurgery is an open comparison, placebo-pdt and pd p 506 a-pdt will be allocated in a double-blind manner.

Eligibility criteria:
inclusion criteria: * written informed consent * caucasians * age \> 18 years * diagnosis of actinic keratosis (ak) with at least four locally separated lesions located on head and/or face (hairless areas) * selected ak study lesions have clearly defined margins and are mild to moderate (grades i or ii) * the distance between the study lesion borders is \> 1.0 cm * maximum diameter of each study lesion is 1.8 cm * skin sun sensitivity type i to iv according to fitzpatrick exclusion criteria: * pdt non-responder * pre-treatment of the ak lesions eligible for study procedures with pharmaceuticals approved for the treatment of ak during the 4 weeks preceding study treatment * pre-treatment of the ak lesions eligible for study procedures during the 2 weeks preceding study treatment with keratolytic agents e.g. tca, urea or salicylic acid containing formulations * pre-treatment with hypericin during the 2 weeks preceding study therapy * treatment with systemic retinoids during the 3 months preceding study therapy * treatment with cytostatics or radiation during the 3 months preceding study therapy * female patients of childbearing potential * patients with clinically relevant suppression of the immune system * diagnosis of porphyria * skin diseases that might interfere with response evaluation of study treatment * skin sun sensitivity type v or vi according to fitzpatrick * known intolerance to one or more of the ingredients of the study medication * known adverse reactions to cryosurgery (including cold urticaria and cold intolerance) * dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent * simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion * suspected lack of compliance

Keywords: pdt ak cryosurgery
tissue perfusion and blood flow monitoring technology

Conditions: Wounds and Injuries

Summary: the purpose of this study is to investigate the safety and efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. the hypothesis is that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.


Eligibility criteria:
inclusion criteria * subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements: * neuropathic diabetic foot ulcer * soft tissue radiation necrosis * crush injury * compromised/failed skin grafts and flaps * subjects must have signed the informed consent forms. exclusion criteria * subjects who are not candidates for hbo therapy for any reason, including but not limited to: untreated pneumothorax, uncontrolled congestive heart failure, seizure disorder, neoplastic tumors, claustrophobia (for those in the hbo group). * female subjects who are pregnant or nursing. * anyone who is unable to give written informed consent. * subjects with end-stage renal disease or who require peritoneal or hemodialysis. * subjects with current malignancies.

Keywords: diabetic wounds hyperbaric oxygen laser speckle imaging hyperbaric oxygenation
efficacy of diclofenac bcg irrigations

Conditions: Bladder Cancer

Summary: this study is designed to test the effectiveness of diclofenac suppositories in the prophylaxis of side effects caused by bcg bladder irrigations in bladder cancer patients.

this study is designed as a double blind placebo controlled randomized study to evaluate the effectiveness of diclofenac suppositories in the prevention of side effects of bcg bladder irrigation in bladder cancer patients. after signing an informed consent, the patients will be randomized to either receive an unmarked suppository of diclofenac or a placebo suppository. the effectiveness of the drug will be tested weekly by quality of life questionnaires and bladder symptom questionnaire. another questionnaire is designed to monitor the time in minutes that the bcg is retained in the bladder before the patients urinates.

Eligibility criteria:
inclusion criteria: 1. bladder urothelial carcinoma patients scheduled fo a set of 6 bcg bladder irrigations at the carmel medical centre 2. male and female 3. age 20-80. 4. patients capable of understanding reading and signing the informed consent form in hebrew. exclusion criteria: 1. diclofenac hypersensitivity 2. pregnancy, lactation 3. elevated creatinine at baseline (male \> 1.2 mg/% female 1.0 mg/%) 4. peptic gastric or duodenal ulcer 5. acute or chronic inflammation of the rectum/ anus (diarrhea, rectal bleeding) 6. gross hematuria (which is per se a contraindication for bcg irrigation)

Keywords: diclofenac bcg bladder irrigations
early recognition of pulmonary arterial hypertension in myelodysplastic and myeloproliferative diseases

Conditions: Myeloproliferative Disorder; Myelodysplastic Syndromes; Pulmonary Hypertension

Summary: myelodysplastic and myeloproliferative disease represent conditions with increased risk for pulmonary hypertension. however, the exact prevalence of pulmonary hypertension in these conditions is not known. the effects of pulmonary hypertension on the clinical picture and the symptoms of patients in these conditions needs also further exploration. this exploratory study is designed to describe the prevalence of pulmonary hypertension in the population with such hematologic diseases, and the stages of pulmonary hypertension as well its effect on exercise capacity at time of diagnosis.

for early recognition of pulmonary hypertension exercise doppler echocardiography will be used in all patients. patients with elevated pulmonary arterial pressure at rest or during exercise (estimated by echocardiography), or with decreased exercise capacity (as a potential sign of pulmonary hypertension) are advised to undergo right heart catheterisation. cardiopulmonary exercise testing and six-minute walk distance measurement are performed to measure exercise capacity. the described work-up of patients allows precise and objective hemodynamic and clinical evaluation.

Eligibility criteria:
inclusion criteria: * myelodysplastic disease or myeloproliferative diseases exclusion criteria: * known pulmonary hypertension * relevant pulmonary disease * relevant left cardiac or valvular disease * recent major operations * recent changes in medications * relevant anaemia * inability to exercise
effects dapagliflozin on inflammatory markers erythropoiesis and iron metabolism in patients with type 2 diabetes and ckd

Conditions: Chronic Kidney Diseases; Diabetes Type 2

Summary: the effect of dapagliflozin on erythropoiesis, iron metabolism and inflammatory markers in ckd with type 2 dm-compare between effect of placebo and dapagliflozin on erythropoiesis, iron metabolism and inflammation markers in ckd with type 2 dm.

type 2 diabetes is considered an important cause of chronic kidney diseases (ckd) ,in those patients the inflammation is the most assumed cause of the decrease in erythropoietin synthesis and abnormal iron metabolism leading to anemia (1_3). sodium glucose cotransporter 2 (sglt2) inhibitors like dapagliflozin are oral medications approved for type 2 diabetes. interestingly, during recent years, they have been promisingly considered as anew medications for cardiovascular and kidney diseases (4). researchers suggested that sglt 2 inhibitors play an important role in reducing ckd progression and renal failure with patients with type 2 dm based on the clinical outcomes and laboratory findings rather than completely understood mechanism (5_8) investigators reported that reduced transferrin saturation (tsat), ferritin and hepcidin and circulating and urinary inflammatory mediators, including monocyte chemoattractant protein-1 (mcp -1 ) and interleukin-6 (il-6) transiently increased epo suggesting sglt 2 inhibition may help iron utilization and promote erythropoiesis decreasing anemia ( 9-14) here we are studying the effects of the sglt 2 inhibitor dapagliflozin regarding markers of erythropoiesis, iron metabolism and inflammation in patients with type 2 dm and ckd.

Eligibility criteria:
inclusion criteria: eligible participants were aged \>18 years and diagnosed with type 2 diabetes participants we required to have urinary albumin-creatinine ratio (uacr ) of 30_3500 mg /g ,egfr of 20_ 80 ml/min/ 1.73 m , and hba1c of 7.0 _ 11.0 % at screening exclusion criteria: type 1 diabetes, non-diabetes kidney disease and patient with hb \< 9
assessing the impact of electronic capture of patient reported outcomes in radiation oncology

Conditions: Patients With Lung, Breast, Head and Neck, or Pelvic Malignancies

Summary: the goals of this study are to assess the feasibility of weekly administration of site specific patient reported assessments using an electronic platform and to explore the correlation between patient reported outcomes as well as known dosimetric prognostic factors in patients with lung, breast, head and neck, or pelvic malignancies


Eligibility criteria:
inclusion criteria: * patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy. * must be ≥ 18 years of age * able to read, write, and speak english in order to complete patient reported outcomes. patients will be approached about the study at the time of consultation or at the time of simulation by their treating physicians or by a research coordinator. all patients must sign a study-specific informed consent to participate. all patients, including those who do not choose to consent to the study, will be provided with a short survey to assess health literacy using the ehealth literacy scale (eheals). for those not consenting to the study, the survey will be de-identified and will also ask for basic demographic information including age grouping, race, education level, and type of cancer.
feasibility and therapeutic potential of free fat grafts in the treatment of esophageal strictures (esograft)

Conditions: Esophageal Stricture; Fat Graft

Summary: in this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to dilation therapy in the treatment of benign esophageal strictures.

in this study the investigators wish to proof the concept of free fat graft transfer into esophageal stricture via flexible video gastroscope.the investigators will recruit twenty patients suffering from (endoscopy proven) benign stricture of the esophagus. the eckardt score is recorded upon recruitment and one day before operation. the operation is performed at the gastroenterology outpatient clinic in turku university hospital by a gastrointestinal surgeon. the patient is sedated with alfentanil and midazolam. first, abdominal liposuction (roughly 20 ml) is performed under local infiltration anesthesia. the fat graft is processed into nano-fat using tulip gems single-use nanotransfer set. esophagoscopy with gastroscope is performed and stricture is visually graded (location, length, lumen) and photographed. then esophageal stricture is biopsied with biopsy forceps and dilated with through-the-scope cre(controlled radial expansion) balloon dilator. prepared fat graft is injected beneath the mucosal layer at the stricture site (volume of 0,1-0,5 ml) at three locations. patients are either discharged after two hours follow up or admitted to the inpatient ward, depending on the pre- and postoperative condition. patients are contacted by phone 1 week after the operation. post-operative symptoms are recorded and patients are requested to contact the researcher if needed. patient records are screened for pre- and postoperative symptoms, medication, long term illnesses and possible postoperative contacts to hospital. follow-up esophagoscopy is performed and biopsies taken three and 12 months after the first operation. the stricture site is visually graded and photographed. the eckardt score is recorded. if the patient has problems with eating (eckardt score dysphagia points more than 1) the stricture is re-dilated and fat grafting repeated. if a patient would have recurrence in dysphagia before three months the patient is treated according to normal routine and dilation is repeated earlier. the follow-up time is 12 months counting from the last fat grafting.

Eligibility criteria:
inclusion criteria: * esophageal stricture that has re-occurred at least once exclusion criteria: * malignant etiology of esophageal stricture

Keywords: esophageal stricture fat graft dilation
treatment of complex post-traumatic stress disorder among displaced people in switzerland

Conditions: Complex Post-Traumatic Stress Disorder

Summary: in who icd-11 (its latest edition), the diagnostic criteria for post-traumatic stress disorder (ptsd) were revised, and a new sibling disorder, complex post-traumatic stress disorder (cptsd) was introduced. cptsd is a debilitating condition associated with severe, prolonged, or chronic trauma. refugee populations are affected by high prevalence of cptsd because of high rates of such trauma (e.g. torture). untreated cptsd has negative consequences for quality of life and for integration into the host society. evidence indicates cultural variation in the phenomenology of cptsd. modular approaches, e.g., the skills training in affective and interpersonal regulation combined with modified prolonged exposure (estair/mpe), have been recommended for the treatment of cptsd. however, they have not been tested in a clinical trial among refugees so far and there are no available publications about their effectiveness in cptsd symptom reduction among this population. research suggests a higher symptom reduction of trauma-focused techniques, such as narrative exposure therapy (net), among refugee population. in a previous study, we pilot tested a version of estair/net that was adapted to sociocultural and structural aspects related to psychopathology in refugee populations. the performance of these culturally adapted modules in cptsd symptom reduction among the refugee population remains to be assessed. the present clinical trial seeks to assess the effect of the culturally adapted modules of the estair manual on symptom reduction among refugees and asylum seekers diagnosed with cptsd.


Eligibility criteria:
inclusion criteria: * informed consent signature * refugees and asylum seekers with a valid residence permit (n, f, b, or c status in switzerland) * speaking one of the four mentioned languages (arabic, farsi/dari, kurdish, and turkish) * a psychotherapy is indicated and was prescribed * participated to the part 1 of the study and was diagnosed with cptsd on the basis of the standard iti and the scsa. the diagnosis is done based on the clinical judgement by the local therapist. exclusion criteria: * acute psychosis * imminent risk of suicide * severe alcohol and/or substance abuse * being enrolled in another psychotherapy * inability to follow study procedures (i.e., cognitive impairment) * inability to give informed consent * known pregnancy

Keywords: refugee populations cultural adaptation factorial experiment culturally sensitive psychotherapy
ocular graft versus host disease after hematopoietic stem cell transplantation in adults

Conditions: Graft Versus Host Disease

Summary: the purpose of this study is to evaluate the presence and manifestations of ocular graft versus host disease in adults that had hematopoietic stem cell transplantation in the past 3 years at the sheba medical center, israel. as well as correlate the degree of the presentation to the therapeutic protocol (chemotherapy and irradiation).


Eligibility criteria:
inclusion criteria: * after hematopoietic stem cell transplantation done at sheba medical center israel * 3 month have past from transplantation but no more then 3 years exclusion criteria: * transplantation done in the last 3 month or more than 3 years have past since
comparison of remimazolam and propofol combination vs. propofol in iom

Conditions: Neurologic Disorder

Summary: this study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. the comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements.

this study hypothesizes that the combination regimen of remimazolam and propofol as total intravenous anesthesia in neurosurgical procedures requiring neurophysiological monitoring can reduce the incidence of hypotension compared to propofol monotherapy while providing comparable levels of neurophysiological monitoring and surgical conditions. with this hypothesis, the study aims to compare the frequency, severity, and duration of hypotension, frequency of patient movement, and appropriateness of neurophysiological monitoring between the combination therapy of remimazolam and propofol and propofol monotherapy in total intravenous anesthesia.

Eligibility criteria:
inclusion criteria: * patients aged 19 and above with planned neurosurgical procedures requiring neurophysiological monitoring, classified as american society of anesthesiologists (asa) physical status classification 1, 2, or 3 in the united states. exclusion criteria: 1. patients who refuse to participate in the study. 2. patients who are pregnant or lactating. 3. patients with hypersensitivity to the investigational drugs or to soy, peanuts, or dextran 40. 4. patients with acute narrow-angle glaucoma. 5. patients with alcohol or drug dependence. 6. patients with hepatic impairment classified as child-pugh class c. 7. patients with lactose intolerance. 8. patients requiring emergency surgery.
cognitive bias and heuristics in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study aims to understand if certain cognitive biases and heuristics are present in patients with knee osteoarthritis being treated with open label placebo (saline injections in the knee). a predefined survey will investigate the affect heuristic and group interviews patients who have responded well or not so well respectively will be used to examine if other cognitive biases or heuristics are present. cognitive biases are systematic patterns of deviation from norm or rationality in judgment, while heuristics are tactics, or mental shortcuts to aid in the decision-making process.

cognitive biases (systematic patterns of deviation from norm or rationality in judgment) and heuristics (tactics, or mental shortcuts to aid in the decision-making process) are increasingly being used in healthcare to facilitate good health decisions, improved care, and in designing new interventions.it has also been shown that cognitive biases influence how patients rate their own health. less is known about which specific cognitive biases and/or heuristics that are in play when patients with knee osteoarthritis form their treatment expectations and evaluate their health following an intervention. this study aims to understand if certain cognitive biases and heuristics are present in patients with knee (oa) being treated with open label intra-articular placebo injections. understanding which cognitive biases and/or heuristics that are in play when these patients evaluate their health outcome following open label placebo, allows future treatment context to be designed in a way that actively utilises these cognitive biases and/or heuristics to obtain a greater magnitude of response. a global predefined questionnaire, evaluating the presence and strength of the affect heuristic, is sent to all participants from the study "reinforcement of treatment response in knee osteoarthritis: a randomised trial" (clinical trial.gov registration: nct05225480). in addition investigators will invite responders and non-responders respectively from the same study to group interviews in order to produce a structured conceptualisation map; the group content mapping method.

Eligibility criteria:
inclusion criteria: * have participated in the study "reinforcement of treatment response in knee osteoarthritis: a randomised trial" (clinical trial.gov registration: nct05225480) exclusion criteria: * have not participated in the study "reinforcement of treatment response in knee osteoarthritis: a randomised trial" (clinical trial.gov registration: nct05225480)
molehill mountain feasibility study.

Conditions: Anxiety; Autism

Summary: up to half of autistic people experience anxiety symptoms, which can have a significant impact on everyday wellbeing. however, there are currently very few effective, evidence-based interventions to support autistic people in managing anxiety; and many autistic people face barriers in accessing inperson health and social care services. therefore, developing new interventions (and/ or adapting existing ones) that improve anxiety, in a way that meets the needs of autistic people, represents the autism community's number one priority for research and clinical practice. addressing this priority, the investigators will test the acceptability and feasibility of a new, app-based therapeutic approach for anxiety ('molehill mountain') that has been developed with, and adapted for, autistic people aged 12-years and over using adapted cognitive behavioural therapy principles. this means that information will be collected from autistic people accessing clinical services on whether they would choose to use the anxiety app, whether the app is simple to administer and use, how it is used, how it can be improved, and whether it is effective in reducing anxiety symptoms and/ or enhancing other outcomes, such as everyday wellbeing and functioning. the evidence from this project will inform the future optimisation and implementation of molehill mountain in a randomised-controlled trial, with the ultimate aim of transforming long-term healthcare delivery for autistic people.


Eligibility criteria:
inclusion criteria: * age ≥ 16-years. * autism diagnosis. * current mild-to-severe anxiety symptom severity, as assessed at screening (and currently in touch with mental health services e.g., referred, on the waitlist). * able and willing to provide verbal and written informed consent to take part in the study. * access to molehill mountain app via smartphone or other smart device. exclusion criteria: * difficulties with reading/ writing to the extent that the app is inaccessible. * high risk of self-harm that make participation in the study inappropriate for the individual's current level of clinical need (as assessed by clinical team). * attended ≥ 6 sessions of individual or group therapy (e.g., cognitive behavioural therapy) in the past 6-months, which would make it impossible to parse out the effects of the app from existing therapy. * if using psychotropic medication, this medication/ dose must have been stable for a minimum of 8-weeks on entry to the study.