Kornimate/medical-research-clean huggingface dataset:
mac-cbt group therapy for adults with adhd

Conditions: Psychotherapy

Summary: the study is developed to validate a new short psychotherapeutic group treatment for adults with adhd diagnosis. the participants will be treated in a monocentric, parallel group randomized superiority study - one group with the new treatment and one group with well established relaxing treatment.

background: attention deficit hyperactivity disorder (ad(h)d) symptoms are often assumed to decease in adolescence, however in up to 60% of children, ad(h)d persists into adulthood. currently, pharmacological therapy is the number-one choice ad(h)d treatment. despite its evidenced effects of pharmacological interventions there are side effects, contraindications and non-responders, which send some patients disliking the use of medication and asking for alternative treatments. in previous studies mindfulness-based interventions already have shown similar effects in neural regions as pharmacological treatment and positive changes in ad(h)d symptoms, quality of life, awareness and concentration. the following study wants to improve mindfulness-based treatment approaches in ad(h)d with a new therapy concept. methods: mindfulness, acceptance, commitment and cognitive behavioral group therapy (mac-cbt) combines 3rd wave therapies with focus on mindfulness meditation, acceptance of unchangeability, commitment to new goals with elements of cognitive behavioral therapy. the design of this study is a single-center, parallel-group, randomized superiority trial. the aim is to compare mac-cbt group with progressive muscle relaxation training (pmr by jacobson). both groups will be held over a period of eight weeks. participants will be assessed two times before treatment to determine natural course of adult ad(h)d and two times after treatment to evaluate short and long term effects. a questionnaire battery and neuropsychological tests are to be used to obtain results regarding a possible change in the symptoms and attention, including selective attention. discussion: this trial will offer new knowledge about the effects of third wave therapies on ad(h)d. furthermore, the following study is one of few studies that will compare ad(h)d treatment to relaxation training instead of comparison to waiting list. the aim of the following study is to verify previous outcomes of mindfulness-based treatments on ad(h)d and to evaluate superiority of mindfulness towards relaxation programs.

Eligibility criteria:
inclusion criteria: * adult adhd * written informed consent * stable medication for at least two weeks * sufficient knowledge of the german language exclusion criteria: * personality disorder * schizophrenia / psychotic disorders * bipolar disorder * acute suicidality * disease of the central nervous system * no other psychotherapeutic treatment at the time of the study * pregnancy * iq below 70 points

Keywords: cognitive behavioral therapy mindfulness acceptance commitment adult adhd
[18f]alf-nota-pentixather pet/ct in patients with suspected primary hyperaldosteronism

Conditions: Aldosterone-Producing Adenoma

Summary: the study was proposed to include 20 patients with clinical suspicion of primary aldosteronism for \[18f\]alf-nota-pentixather pet/ct imaging and to analyze the specificity and sensitivity of \[18f\]alf-nota-pentixather pet/ct for the diagnosis of apa by comparison with the final pathological findings.


Eligibility criteria:
inclusion criteria: * persistent hypertension or refractory hypertension (blood pressure \>140/90 mmhg with a combination of three antihypertensive drugs, including diuretics) with hypokalemia of blood pressure \>160/100 mmhg. * uncontrollable hypokalemia with or without hypertension. persistent hypertension or refractory hypertension with blood pressure \>160/100 mmhg and aldosterone-renin ratio (arr) ≥30 (ng/dl)/(ng/ml/h). * positive captopril test (≤30% decrease in plasma aldosterone level after captopril administration) is a sufficient but not mandatory condition. * patients with ct showing unilateral or bilateral adrenal nodules with well-defined borders but normal serum potassium and arr \<30 (ng/dl)/(ng/ml/h) were also included in the study. exclusion criteria: * female patients who are pregnant (or intend to become pregnant within six months), breastfeeding, or unwilling to use contraception. * abnormal cardiopulmonary function or mental status, unable to tolerate prone for 20 minutes. * refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved study protocol. * other conditions deemed by the investigator to be inappropriate for participation in this study.
ongoing effect of expansion prisms following the discontinuation of use on visual field enlargement and retrograde ganglion cell degeneration in homonymous hemianopia patients

Conditions: Homonymous Hemianopsia

Summary: the goal of this observational study is to learn about the long-term effects of pelli prism in hemianopia patients who take prisms for awareness of the area they cannot see. the main question it aims to answer is: does the field enlargement observed with the prism continues after the prism is removed? participants already using peli prisms as part of their regular medical care for hemianopia, in the upcoming routine controls their field of vision enlargements will be examined.

hemianopia is a disability-causing condition that usually affects young to middle-aged people and reduces quality of life.prism applications are one of the rehabilitation methods used to improve the quality of life of these people and ensure their participation in daily life. the peli prism is the most commonly used prism type. the effect of prism applications is thought to be temporary.the main idea of our study is that prisms can create longlasting effects by affecting neuroplasticity.

Eligibility criteria:
inclusion criteria: homonim hemianopsia patient age between 18-55 years h.hemianopia, diagnosed at least six months before the initial examination neurological condition is suitable for daily activities exclusion criteria: - failure to meet age criteria hemianopia developed more recently than 6 months ago having to use medications that affect his/her balance and daily activity

Keywords: homonium hemianopsia retrograde ganglion cell degeneration neuroplastisity, vision therapy, peli prism
swartz sheath with angioplasty guidewire-assisted technique for patent foramen ovale closure (stage-pfo)

Conditions: Patent Oval Foramen

Summary: the technical challenge in patent foramen ovale (pfo) closure lies in successfully establishing an occlusion pathway through the pfo tunnel using a guidewire or catheter. in this study, we aim to investigate the efficacy and safety of swartz sheath with angioplasty guidewire-assisted technique for pfo closure.

in cases of complex pfo, failure of guidewire passage through the septum can occur, rendering closure impossible. the present multicenter, prospective, randomized controlled trial aims to evaluate the efficacy and safety of a novel swartz sheath with angioplasty guidewire-assisted technique to facilitate pfo tunnel passage. with written consent, the investigators expect to enrol pfo patients with a history of cryptogenic stroke (cs) or transient ischemic attack (tia), who requires pfo closure according to current guidelines. a standardized tee protocol is used to assess the morphologic characteristics of the atrial septum and right-to-left shunting through pfo. eligible patients are prospectively and randomly assigned to the swartz sheath + angioplasty guidewire group or the conventional group (1:1 ratio). in the swartz sheath + angioplasty guidewire group, the pfo closure procedure is performed with swartz sheath + angioplasty guidewire assistance. in the conventional group, the pfo closure procedure is performed with a multi-functional catheter. after the procedure, safety parameters such as contrast use, procedure time, and severe complications are recorded. all patients are followed up at 1-, 3-, 6-, and 12- month post device implantation. the presence of a residual shunt, device embolization, device migration and residual shunt are recorded.

Eligibility criteria:
inclusion criteria: * aged between 18 and 65 * confirmed diagnosis of pfo by transthoracic and transesophageal echocardiography * a history of cryptogenic stroke (cs) or transient ischemic attack (tia) exclusion criteria: * confirmed pregnancy * confirmed diagnosis of intracardiac thrombosis * confirmed diagnosis of pulmonary hypertension * confirmed diagnosis of rheumatic heart disease, or valvular heart disease * past medical history of myocardial infarction, unstable angina and intracranial hemorrhage
changes in physical functioning in patients with copd during therapy with a combination inhalation therapy

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the decrease in physical activity due to increasing dyspnoea that over time leads to a steadily worsening condition and increasing restriction of physical functioning is a key problem for copd patients and affects even the early stages. clinical studies to investigate both spiriva® and striverdi® respimat® have demonstrated a marked improvement in physical exercise capacity. however, there have so far been no data from the daily practice setting about everyday functioning on combination treatment with spiriva® respimat® plus striverdi® respimat® or spiriva® 18 mikrogramm plus striverdi® respimat® in patients requiring treatment with 2 long-acting bronchodilators. the objective of this nis is to measure changes in physical functioning as a surrogate for physical activity and exercise capacity in copd patients on treatment with spiriva® respimat® plus striverdi® respimat® or spiriva® 18 mikrogramm plus striverdi® respimat® in routine daily treatment (so-called real life setting).


Eligibility criteria:
inclusion criteria: * female and male patients \>= 40 years * copd gold 2014 b - d * treatment with spiriva® respimat® plus striverdi® respimat® or spiriva® 18 microgramm plus striverdi® respimat® acc. to the summary of product characteristics (smpc), no change of routine diagnostics and treatment * signed informed consent form before inclusion into the non-interventional study (nis) exclusion criteria: * patients with contraindications acc. to the summary of product characteristics (smpc) * pregnant and breastfeeding women * patients who are taking part in a different non-interventional study (nis) or an interventional clinical study at the same time are not to be enrolled
objective characterizatoion of repetitive behaviors

Conditions: OCD; Tic Disorders; Gilles De La Tourette Syndrome

Summary: introduction: repetitive behaviors (rb) constitute a broad range of symptoms across different psychiatric/neurologic disorders. the most famous are stereotypies (found in autism), compulsions (found in obsessive-compulsive-disorder, ocd) and tics (found in gilles de la tourette syndrome, gts). for some patients, it is sometime difficult to distinguish the nature of the repetitive behaviors presented, however this distinction is crucial in order to chose the appropriate treatment. aim: in our study, the investigators will try to define electrophysiological and accelerometric marker of both ocd and tics to allow objective distinction between both tics and compulsions. method: subjects: both ocd and gts patients will be recruited, 25 patients in each group. protocol: our study protocol will involve two step: a step in laboratory, another step at patient home. * first step: both patients group will be recorded through a high density eeg and a portative eeg while doing a task of symptom provocation. then they will get an anatomical mri for source recontruction. finally, the patients will have to mimic their symptom while wearing an accelerometer (a smartwatch). * second step: both patient groups will be recorded at home through a portative eeg while tagging their symptom through a smartwatch (also used for accelerometry). after the recording, the patients will keep the smartwatch for 2 weeks, still tagging their sympoms (compulsions or tics).


Eligibility criteria:
inclusion criteria: * to be more of 15 years old or less than 65 years old * to suffer from ocd and/or gts (depressive, anxious and attention deficit hyperactivity disorder (adhd) comorbidities are accepted) * to be registered to the french social security (or something equivalent) * to give written consent to participate to the research * to have contraception for women participants (or to not have any sexual activity) exclusion criteria: * patients with any other psychiatric disorders than those mentioned in the inclusion criteria * patients with any other neurological disorder than gts * patients who are not able to take decisions for themselves * pregnant women * patients not allowed to get mri due to contraindication * patients not speaking french

Keywords: electrophysiology electroencephalogram eeg accelerometer biomarker symptom provocation
safety and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: this study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension


Eligibility criteria:
inclusion criteria: * diagnosis of pah of either primary (idiopathic), familial or secondary to systemic sclerosis (excluding those with marked pulmonary fibrosis) according to world conference on pulmonary hypertension classification (venice, 2003). * symptoms with a who class of ii-iv exclusion criteria: * use of unspecific phosphodiesterase inhibitors (for example, pentoxyfillin, enoximon, milrinone or pimobendan) during the study * chronic inhaled nitric oxide therapy from start to study completion * treatment with catecholamines (for example, adrenalin, noradrenalin, dopamine), * pre-existing lung diseases, including parasitic diseases affecting lungs, asthma, congenital abnormalities of the lungs, chest, and diaphragm. * pulmonary artery or valve stenosis; pulmonary venous hypertension; chronic thromboembolic pulmonary hypertension * acute heart failure or chronic left sided heart failure; congenital or acquired valvular or myocardial disease * severe (systemic) arterial hypertension (\> 200 mmhg (systolic) or \> 120 mmhg (diastolic)) other protocol-defined inclusion/exclusion criteria may apply

Keywords: pulmonary arterial hypertension, tyrosine kinase inhibitor, sti571
safety and tolerability study of qls-101 in adolescents with sturge-weber syndrome (sws)-related glaucoma due to elevated episcleral venous pressure (evp)

Conditions: Sturge-Weber Syndrome; Glaucoma; Ocular Hypertension

Summary: open-label study of an investigational product (ip), qls-101, with 28-day every morning (qam) dosing to both eyes (ou) in adolescents with sws who have clinical evidence of glaucoma and/or ocular hypertension (oht) related to sws elevated evp in at least one eye.


Eligibility criteria:
inclusion criteria: * between 12 and 19 years of age at screening. * diagnosed with sws * elevated iop * willing to continue current dosing regimen of iop-lowering medications * able to provide informed consent and follow study instructions exclusion criteria: * expected to undergo iop-lowering surgery * incisional or laser surgery of any type 4 months prior to study * ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, history of herpes simplex keratitis in either eye * history of or active clinically significant ocular disease * use of topical ocular corticosteroids in the 6 weeks prior to study * patient cannot be applanated or tolerate iop measurements * patient is pregnant or lactating * uncontrolled systemic disease that can interfere with study participation * inability to self-dose or identify a caregiver for all study eye drop administration
a study to evaluate the benefit of ruconest® in subjects who experience adrs related to ivig infusions

Conditions: CVI - Common Variable Immunodeficiency

Summary: patients receiving intravenous immunoglobulin (ivig) therapy for primary immunodeficiency and neurologic conditions may experience adverse drug reactions (adrs). the mechanism of the adr is unknown. currently, the standard practice for these patients is to change from iv to subcutaneous ig (scig) but because of the need of immunomodulation or patient preference, scig may not be an option. data has shown that some levels of complement decrease from pre- to post-infusion of ivig. this study is to determine if replacing this complement protein may ameliorate adrs.

this is a single-site, pilot study conducted in the us to determine the benefit of human c1-esterase inhibitor \[recombinant\] (c1-inh-r) therapy to ameliorate adrs in subjects receiving ivig therapy experience adrs post-infusion. subjects who are currently receiving ivig for immunodeficiency or neurologic conditions and experience adrs will be enrolled. in part 1, subjects will continue to receive ivig for two infusions. complement proteins will be measured pre- and post-infusion. quality of life and other questionnaires will be administered. in part 2, subjects will receive c1-inh-r infusion prior to receiving ivig infusion for three infusions. complement proteins will be measured pre- and post- infusion. quality of life and other questionnaires will be administered.

Eligibility criteria:
inclusion criteria: * age 18 years and older experiencing adrs related to ivig infusions * stable dose of ivig for 3 months * willing to comply with all aspects of the protocol, including blood draws * female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. acceptable forms of contraception are defined as those with a failure rate \< 1% when properly applied and include: a combination oral pill, some intra-uterine devices, and a sterilized partner in a stable relationship. female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire study period. exclusion criteria: * receiving treatment for hae, either prophylactic or acute therapy * patients with medical history of allergy to rabbits or rabbit-derived products (including rhc1inh) * patients who are pregnant, or breastfeeding, or are currently intending to become pregnant. * patients who, in the investigator's opinion, might not be suitable for the trial

Keywords: intravenous immunoglobulin c1-esterase inhibitor adverse drug reaction (adr)
effect of bariatric surgery on cognition, genetics and lifestyle

Conditions: Obesity, Morbid

Summary: obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (\~ 2 years). there is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. the intention of this project is to investigate whether bariatric surgery is associated with patients' cognitive ability, lifestyle and/or gene expression and metabolomics.


Eligibility criteria:
inclusion criteria: * first bariatric surgery exclusion criteria: * more than one surgery

Keywords: bariatric surgery cognitive function gene expression metabolomics obesity overweight lifestyle
digital outpatient services

Conditions: Epilepsy; Cancer; Interstitial Lung Disease; Long Term Pain

Summary: more people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without leading to more patient readmissions. further, new services should take into account the patients capacity to benefit from the services, and their level of health literacy is crucial. by developing new services using technology, patients will be able to be followed up closely in their own home with adapted treatment and information, a closer dialogue with the health service where there is a need, and the utilization of scarce resources in the health care system can increase. the aim of the current study is to evaluate a digital outpatient clinic, and assess any differences over time in health literacy, digital health literacy, quality of life and overall satisfaction with the outpatient services. furthermore, the investigators will assess the intervention group's satisfaction with the digital outpatient clinic. in addition, the digital services will be tailored and revised throughout the study based on continuous feedback and iterative processes. the current study is a pragmatic controlled multicenter study with two study arms; one control arm and one intervention arm. in total, eligible participants will be recruited from one of four centers.


Eligibility criteria:
inclusion criteria: * patients attending the study centers that are cognitively able to use a digital outpatient service with no major conflicting disorders, with one of the following disorders: * cancer * epilepsy * interstitial lung disease * long-term complex pain conditions exclusion criteria: * under the age of 18 * any mental or cognitive conditions interfering with their ability to participate

Keywords: digital outpatient services health literacy mhealth ehealth satisfaction controlled trial
diagnostic qualities of the positron emission tomography coupled to the scanner (pet / ct) in the assessment of response to non-hodgkin's lymphoma therapy in children and adolescents

Conditions: Non-Hodgkin Lymphoma

Summary: this is a diagnostic prospective multicenter study. this study will be conducted in 32 centers of the société française des cancers et leucémies de l'enfants et de l'adolescent (scfe) in patients with non-hodgkin lymphoma and treated according to recommendations of the sfce for each type of non-hodgkin lymphoma. all patients will have a pet / ct associated with conventional imaging time of remission assessment. histological examination of residual tumor will be conducted whenever practicable in patients with pathologic residual image on conventional imaging and / or pet / ct. a central review of conventional imaging examinations and pet / ct will be performed independently from each other. moreover, whenever possible, patients will have a pet / ct at diagnosis and an early pet / ct (between j8 and j28 according to the type of lymphoma and toxicities due to treatment). the results of the early pet / ct should not lead to treatment modifications. in case of residual tumor at remission assessment, therapeutics changes as recommended therapeutic protocols will be based on histologic findings and not on the results of pet / ct alone.


Eligibility criteria:
inclusion criteria: 1. all cases of nhl corresponding to one of the following histologies: * burkitt and burkitt-like (lb) * large cell b-cell lymphoma (lbgc) * primary mediastinal b cell lymphoma (lbpm) * lymphoblastic lymphoma (ll) * anaplastic large cell lymphoma (alcl) 2. age \> 2 years and \< 21 years 3. treated in a sfce protocol 4. treated in a center with the possibility of organizing a pet / ct at the time of remission assessment 5. affiliation to a social security system 6. possible follow-up for at least 2 years 7. written informed consent signed by the parents or parental authority or the patient himself if he is over 18 years exclusion criteria: 1. relapsing patients 2. patients with absolute cons-indications to the achievement of a pet scan: pregnancy, incontinence, poorly controlled diabetes or blood glucose\> 10 mmol/l, alterations of superior functions or claustrophobia, making the test impossible. 3. pre-existing or evolving infectious inflammatory disease making pet / ct difficult to interpret

Keywords: children and adolescents