cyrilzakka/clinical-trials huggingface dataset:
Mindfulness, Empathy and the Oxytocinergic System in Persons With Schizophrenia

Recent studies indicated positive effects of mindfulness-based interventions (MBI) for schizophrenia (SCZ), but also on oxytocin (OXT) levels in healthy persons. It was also shown that response to MBI could be shaped by genetic factors. However, the interplay between mindfulness and empathy and genetic factors with the oxytocinergic system has not yet been examined in SCZ. The aim of the current explorative study is to (1) explore the effect of mindfulness-based group therapy (MBGT) on OXT levels as well as empathy in persons with SCZ; (2) investigate whether polygenic risk scores (PRS) for empathy can predict empathy levels in persons with SCZ; (3) investigate whether PRS for empathy and specific genetic configurations in the oxytocin receptors are associated with MBGT outcomes and OXT levels; 4) examine changes in positive- and negative symptoms, depression, anxiety, social functioning, and mindfulness at a within-group level and between both conditions.

A parallel-group, proof-of-concept randomized controlled trial with 30 participants allocated to each trial arm (N = 60) will be conducted. Participants will be randomly assigned to MBGT alongside treatment as usual (MBGT+TAU) or treatment as usual (TAU). For a treatment period of four weeks, participants will receive weekly MBGT sessions. Four weeks after baseline assessments (T0), post-intervention assessments (T1) will take place. As a pilot study, effect sizes will be estimated for within- and between-group effects with corresponding confidence intervals.

Outcomes of our proof-of-concept study can provide insight into potential biological mechanisms underlying mindfulness in SCZ, determine a valid biomarker associated with empathy and negative symptoms and pave the way for a personalized treatment approach for individuals with SCZ.


Eligibility Criteria:
Inclusion Criteria:

* be aged between 18 and 65
* meet diagnostic criteria for schizophrenia (ICD-10: F20.X) ascertained by a trained psychiatrist
* sufficient German language proficiency to engage with the intervention
* no recent (\<4 weeks) major change in psychopharmacologic medication
* be able to give written informed consent

Exclusion Criteria:

* a score of 7 on any item of the positive scale of PANSS, suggesting severe psychotic symptoms
* acute suicidality
* current substance use other than nicotine
* neurological disorders or brain damages
An Observational Study to Assess the Real-World Effectiveness of Upadacitinib in Adult Participants With Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study will assess the clinical and patient-reported outcomes with upadacitinib in adult participants with moderate-to-severe RA in a real-world setting.

Upadacitinib is an approved drug for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. Adult participants with moderate-to-severe RA will be enrolled. Around 150 participants will be enrolled in the study in multiple sites in the United Kingdom.

Participants will receive upadacitinib per their physician's usual prescription. Individual data will be collected for 6 months.

No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.


Eligibility Criteria:
Inclusion Criteria:

* American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) confirmed diagnosis of rheumatoid arthritis (RA).
* Moderate RA (defined by National Institute for Health and Care Excellence \[NICE\] as 28-joint Disease Activity Score \[DAS28\] C-reactive protein \[CRP\] \>3.2 and ≤5.1) or severe RA (defined by NICE as DAS28 CRP \>5.1) at the time of enrollment.
* Prescribed upadacitinib in line with marketing authorization.
* Decision to treat with upadacitinib has been made independently and prior to enrolment in the study.
* Able to read and understand English.
* Willing and able to participate in the collection of patient-reported data via mobile app.

Exclusion Criteria:

* First dose of upadacitinib received prior to enrollment in the study (same day permitted) or more than 28 days after enrolment into the study.
* Previously received \>4 biologic disease-modifying antirheumatic drugs (bDMARD) (1 switch to a biosimilar for non-clinical reasons is allowed for each bDMARD received) or any Janus kinase (JAK) inhibitor for the treatment of RA.
* In the opinion of the treating clinician, participant symptoms are predominately being driven by fibromyalgia or unrelated pain component instead of underlying inflammatory disease.
* Participation in any interventional clinical trial within the 3 months prior to initiation or at any point during the study observation period.
Utrecht Coronary Biobank (UCORBIO)

UCORBIO enrolls patients who undergo coronary angiography (for any indication). The investigators draw blood at the moment of insertion of the procedural arterial catheter.

At the moment of inclusion indication, procedural details, risk factor status, medication use and quality of life (RAND-36 and EuroQoL) is assessed. Patients are then followed-up for the occurrence of major adverse cardiovascular events for 5 years. During the follow-up period patients receive a questionnaire every year to check for hospital admissions. The questionnaires at two and five years of follow-up are enriched with quality of life questionnaires (RAND-36 and EuroQoL).


Eligibility Criteria:
Inclusion Criteria:

* Coronary angiography

Exclusion Criteria:

* Age \< 18 years.
Evaluation of Hand Strength and Spasticity in Hemiplegic Patients

The aim in this study is to evaluate spasticity and hand grip strength with a finger hand robot in the Turkish population.

Spasticity has been defined as "irregular sensorimotor control resulting from upper motor neuron lesion manifesting as intermittent or sustained involuntary activation of muscles".

The commonly used tools in the evaluation of spasticity are subjective clinical scales, including Ashworth Scale (AS), Modified AS (MAS), Tardieu Scale (TS), Modified TS (MTS), and Tone Assessment Scale (TAS). Current scales are based on the clinician's perception of the patient assessing spasticity through their perceptions, experience, and training over the years. An objective measure of spasticity is required, and the development of robot-based systems for this purpose can help clinicians objectify their assessment.

It has been widely shown that robotic systems can be useful in the rehabilitation of adults and children with brain damage. In addition, these systems can be used to assess upper extremity function during treatment.

The aim in this study is to evaluate spasticity and hand grip strength with a finger hand robot in the Turkish population.

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patients with sufficient cognitive and language skills to follow instructions will be included in the study.

Exclusion Criteria:

* Uncooperative Patient
* Having a skin ulcer on the hand,
* Patients with contractures of the hand fingers will be excluded.
Aquatic-based Explosive Strength Training in Children With Cerebral Palsy

This study was designed to assess the effect of a 12-week aquatic-based plyometric (Aqua-PLYO) training on postural control and functional performance in children with hemiparetic cerebral palsy (h-CP). Fifty-six children with h-CP were randomly allocated to the Aqua-PLYO group (n = 28, received an Aqua-PLYO training program, trice/week, over 12 weeks) or the control group (n =28, received standard rehabilitation). Both groups were assessed for postural control and functional performance pre and post-treatment.

Fifty-six children with h-CP were recruited from the Physical Therapy Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 12 and 16 years, were functioning at levels I or II on the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, had leg-length discrepancy, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, attentional neglect, cardiopulmonary problems preventing them from performing high-intense exercise training.

Outcome measures

1. Postural control: The dynamic limits of stability (LOSdynamic) indices were measured through the Balance Master system.
2. Functional performance: Functional performance was quantified using the 30-second sit-to-stand test (30sec-STS), Timed Up and Down Stairs test (TUDS), and the Dynamic Gait Index (DGI).

The Aqua-PLYO group received a 12-week Aqua-PLYO training, 45 minutes per session, three times a week for 12 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The Aqua-PLYO program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities conducted in a water medium. The Aqua-PLYO training included a warm-up for 10 minutes and a cool-down for10 minutes. The control group received the usual physical therapy care, 45 minutes per session, three times a week for 12 consecutive weeks. The program consisted of advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.

Eligibility Criteria:
Inclusion Criteria:

* Hemiparetic cerebral palsy
* Age between 12 to 16 years
* Spasticity level 1 or 1+ according to the Modified Ashworth Scale
* Gross motor function level I or II according to the Gross Motor Function Classification System

Exclusion Criteria:

* Structural deformities
* Musculoskeletal or neural surgery in the last year
* BOTOX injection in the last 6 months.
* Cardiopulmonary disorders limit the ability to engage in explosive exercise training
* Hemi-spatial neglect
Honey in Chronic Immune Thrombocytopenia

Based on the assumption that honey may have an immunomodulatory effect, the aim of our present study will be to verify whether the intake of honey, as a natural substance, in patients with chronic Immune Thrombocytopenia (ITP) could affect the platelet number and hence could affect the bleeding severity. Thirty patients suffering from chronic ITP will be recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University, Cairo, Egypt. The diagnosis of ITP will be based on the presence of isolated thrombocytopenia with a peripheral blood platelet count less than 100 x 109/L, and absence of any obvious initiating and/or underlying cause of the thrombocytopenia. Chronic ITP is defined as ITP for at least 12 months. The age of the patients will range from 5 to 15 years, and they will be of both sexes. This study was approved by the local Ethics Committee of the Pediatric Department of Ain Shams University, and an informed consent to participate in this study will be obtained from at least one parent of each patient. Furthermore, an ascent form will be obtained from each patient above 7 years of age.

Study design:

A crossover design (two 12-weeks intervention periods) will be used to measure treatment effects. The subjects will be randomized into two groups (intervention to control \[I/C\] and control to intervention \[C/I\] groups). Each study group will have 15 subjects. The subjects in the I/C group will consume 2 ml honey/kg/dose (maximum 50 ml/dose), twice weekly in the first 12-week period (period 1) while the subjects in the C/I group will not receive honey as a Control in period 1. After period 1 the subjects of each group will exchange their protocol for the following 12-week period (period 2). This design will allow the treatment effects to be measured between the study groups (namely between the different subjects) in the same study period, or period 1, as well as in the same subjects in a crossover comparison of periods 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic ITP who did not receive any treatment specific for ITP within the past 3 months
2. Who did not receive bee honey or any medication that may affect platelet number or function within the past 3 months and
3. In whom the bleeding severity will range from 1 to 3 (mild to moderate bleeding) according to Buchanan and Adix (2002).

Exclusion Criteria:

1. Grade 4 bleeding severity, according Buchanan and Adix (2002) and
2. Presence of diabetes mellitus.
Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma

The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid

Exclusion Criteria:

* Participation in a prior FlutiForm study
* Smoking history within the last 12 months,
* Significant, non-reversible, pulmonary disease
* Life-threatening asthma within the last year
Pharmacokinetics of Anacetrapib (MK0859) in Patients With Hepatic Insufficiency (MK-0859-039)

This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study
* Subject is in good health
* Subject agrees to refrain from consumption of red wine, grapefruit, orange and apple juices throughout the study

Exclusion Criteria:

* Patient has a history of cancer
* Patient is a nursing mother
* Patient is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
* Patient consumes excessive amounts of alcohol or caffeine
* Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung

To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in subjects of the established SALIA-cohort and the preventive effects on lung function decline.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females (75 - 80 years)
* FEV1/FVC \< 0,77 (in the investigation 2007/2008)
* Inflammatory markers TFN-alpha \> median or neutrophilic granulocytes \> median (investigation 2007/2008)
* Non smokers or ex smokers who have stopped smoking for longer than 6 months

Exclusion Criteria:

* Participation in another clinical study in the previous month
* Severe concomitant disease which may have an impact on the study participation
* Hypersensitivity against Ectoin
* Myocardial infarction or apoplexy within the last year
* Uncontrolled hypertension: systolic blood pressure \>200 mmHg or diastolic pressure \>120 mmHg
* Known aortic aneurysm
* Other respiratory diseases (e.g. cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, allergic alveolitis, tuberculosis, etc.)
* Patients who have had treatment with live attenuated vaccinations within 14 days prior to screening visit (Inactivated influenza vaccination is acceptable, provided it is not administered within 7 days prior to screening visit)
* on investigators decision
The CARS Study: Communicating About Readiness (for Discharge)

The purpose of this study is to improve the experience of discharge of adult medical surgical patients through improved discharge preparation communication between patients and care team members, with subsequent improvement in the post-discharge experience. Obtaining multiple perspectives on discharge readiness creates the opportunity for patient and care team to partner in identifying deficiencies in discharge readiness that warrant anticipatory, compensatory, or corrective interventions prior to discharge, with the goal of averting post-discharge problems and utilization. The results will also inform development and translation of tools for assessment of discharge readiness to clinical care environments.

Specific Aims are to:

1. Describe patterns of communication about discharge and collaboration among members of the health care team
2. Conduct psychometric testing of 3 forms of the Readiness for Hospital Discharge Scale (RHDS - MD, RN, Patient)
3. Describe relationships between care team communication, patient perceptions of quality of discharge preparation and perceived readiness for discharge, care team (RN and MD) assessments of discharge readiness, and post-discharge outcome ( post-discharge coping difficulty, Emergency Department (ED) use, and 30 day readmission.
4. Determine the impact of an intervention with the inpatient care team to improve discharge preparation communication.

H1: Patient perceptions of discharge readiness, post-discharge coping difficulty, ED use and readmission will improve following a care team educational intervention about discharge preparation, compared to pre-intervention baseline measures.

H2: Care team members will report improved frequency and amount of discharge preparation communication following a care team educational intervention about discharge preparation, compared to pre-intervention baseline measures.

H3: RN-MD collaboration will increase following a care team educational intervention about discharge preparation, compared to pre-intervention baseline measures

Eligibility Criteria:
Inclusion Criteria:

* inpatient care team members from 2 nursing units of an academic medical center: Attending physician, resident, medical students, mid-level providers, staff RNs, and case managers/discharge coordinators
* adult medical-surgical patients admitted the 2 nursing units who are at least 18 years of age, speak English, and discharged directly home

Exclusion Criteria:

* patient discharged home with hospice care
* patients not discharged directly home
* decisionally incapacitated patients
Behavior of Children Related to Numbness After Dental Local Anesthesia

In children, behavior management is critical to the success of pediatric dental procedures. Most of the studies on local anesthesia performed in children deal with the question how to avoid or minimize pain during injection. Due to the sensation of numbness children scratch the soft tissues and bite lips and tongue. In many cases, this may be kept in children's memory as a "painful experience" and may affect their behavior in the following visit. The purpose of this study is to evaluate children's reactions to the administration of local anesthetic injection in the mandible (mandibular block) and in the maxilla (supraperiosteal infiltration), and to assess their behavior in the following visit related to each type of injection.

Children between the ages of 4 to 7, undergoing dental treatment at the Department of Pediatric dentistry of the Hadassah School of Dental Medicine will participate in the study. All patients should be ASA Class I with no prior dental treatment who need at least two clinical sessions of similar operative procedures preceded by local anesthetic injection, one in each jaw, none of which due to emergency. Subjective and objective evaluation will be performed according to previously validated scales.

Eligibility Criteria:
Inclusion Criteria:

* Age: 4-7
* Behavior: Frankel 3-4
* No sedation (premedication)
* ASA 1
* No dental treatment before
* Need for similar treatment in the upper and lower jaw
* No emergency treatment

Exclusion Criteria:

* Need of premedication
* Uneven treatment in each jaw
480 Biomedical Sinus Drug Depot

This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CS.
* Female study subjects of child-bearing potential must have a negative pregnancy test and must agree to not become pregnant during the course of the study.
* The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site.
* The study subject agrees to comply with all study requirements

Exclusion Criteria:

* Known history of intolerance to corticosteroids.
* Oral-steroid dependent condition.
* Having had corticosteroids with potential systemic effect (e.g., oral, parenteral, or high dose topical) 1 month prior to screening visit.
* Subjects with acute or chronic intracranial or orbital complications of chronic rhinosinusitis (e.g., brain abscess, related problems with eyes or central nervous system).
* Known history of hypothalamic pituitary adrenal (HPA) axial dysfunction or having morning serum cortisol level at screening outside of normal range.
* Previous pituitary or adrenal surgery.
* History or diagnosis (in either eye) of glaucoma, ocular hypertension, or cataracts.
* Recent participation in another clinical trial within 1 month of screening visit.
* Subjects currently participating in an investigational drug or device study.
Validation of Sensitivity and Specificity of a Multi-Omic Precision Diagnostic for Acute Stroke Evaluation

Valtari Bio has early proof of concept clinical data of a multi-omic peripheral blood biomarker profile that can be used to determine stroke from no stroke in the emergency setting. The objective of this observational cohort clinical study is to determine the clinical utility of this multi-omic biomarker profile.

Primary Study Aims:

1. The diagnostic tests characteristics of a multi-omic biomarker diagnostic for stroke (ischemic stroke, transient ischemic attack (TIA) and hemorrhagic stroke) versus no stroke (stroke mimic).
2. The ability of a multi-omic biomarker profile to differentiate ischemic stroke from hemorrhagic stroke and TIA.

At the completion of this project the investigators will have evaluated a peripheral blood test that determines the expression of a multi-omic biomarker profile to differentiate stroke from no-stroke in the emergency setting. Five hundred patients aged 18 years or older who present to the hospital with stroke-like symptoms will be recruited within 24 hours of symptom onset at participating clinical sites. Data will be obtained from the medical records. Blood for research purposes will be obtained. Research evaluations for stroke severity, symptoms and outcome will be performed by trained personnel. All clinical evaluation and management will be per standard of care.

The primary outcome of this study is the criterion standard stroke diagnosis. This will be used to estimate the diagnostic test characteristics of a multi-omic biomarker profile in the peripheral whole blood for distinguishing stroke (IS, TIA, SAH, ICH) versus non-stroke in ED patients with acute neurologic symptoms. Secondly, the investigators will estimate the ability of the multi-omic biomarker profile to differentiate between stroke subtypes. A diagnosis of stroke will be defined as clinical syndromes consistent with stroke (i.e., sudden onset neurological deficit) plus imaging confirmation (or symptom resolution and lack of imaging findings in TIA). Finally, the investigators will explore the relationship between the multi-omic profile and time from symptom onset in ischemic stroke patients. Descriptive and inferential statistics will be used to address the aims of the study. Pattern recognition analysis and machine learning will be employed as a systems level approach to determine relevant pathophysiologic pathways associated with diagnosis and symptom onset time.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older who present with symptoms of a possible stroke in whom blood can be collected for this study within 12 hours of symptom onset will be eligible.

Exclusion Criteria:

* Age less than 18 years