cyrilzakka/clinical-trials huggingface dataset:
Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

This study is a double-blind randomized clinical trial with two arms which aims to study the effects of diaphragmatic treatment in patients with nonspecific low back pain.

Low back pain has a great importance in today's society, and it is therefore important to develop an effective treatment for this condition. People with chronic nonspecific low back pain, can present respiratory disorders and get anxiety states, affecting mainly the diaphragm muscle. Therefore, given its direct anatomic relationship, the diaphragm may be part of the development of chronic low back pain. Although clinical practice guidelines for chronic low back pain have been developed, it hasn't been explored before a physiotherapy treatment especially aimed at a diaphragmatic treatment.

A double-blind randomized clinical trial with two arms will be used for this purpose, 64 patients with nonspecific low back pain referred from different hospitals of Castellón will be randomized into two groups:

* Diaphragmatic intervention with osteopathic manual therapy treatment (D).
* Diaphragmatic intervention with placebo treatment group (P).

An osteopathic manual therapy protocol for the treatment of back pain including techniques for the diaphragm muscle will be applied to the patients in group D, in a total of 5 sessions. For patients in group P, the same protocol will be performed on the diaphragm but with placebo treatment techniques.

The study focuses on the analysis of the following variables: scores on the questionnaires:

* Pain: McGill Pain Questionnaire and VAS (Visual Analogical Scale ).
* Fear Avoidance: (FABQ)
* Disability: Oswestry Disability Index and Roland-Morris
* Anxiety: HADS: (Hospital Anxiety and Depression Scale)
* Catastropizing: PCS (Pain Catastropizing Scale)
* Satisfaction with treatment (Escala de Satisfacción con el tratamiento)

The results of these pre-intervention and post-intervention variables will be compared between the two groups in the first session, in the fourth session and in the first and third month after the first intervention. The VAS score will also be assessed in the second and third session.


Eligibility Criteria:
Inclusion Criteria:

* low back pain for more than 3 months

Exclusion Criteria:

* vertebra fracture
* systemic disease
* spinal surgery
* degenerative articular disease
* acute soft tissue inflammation
* radiculopathy
* structural spine deformities
* pregnancy
* mental disease
* dermatologic disease
* rejection to manual contact
Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease

To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of MEDI6012 in subjects with stable atherosclerosis.

A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects with Stable Atherosclerotic Cardiovascular Disease

Eligibility Criteria:
Inclusion Criteria:

* Non-childbearing potential
* Diagnosis of stable atherosclerotic CVD
* Currently receiving a stable dose of Statin

Exclusion Criteria:

* Unstable cardiovascular condition within 3 months of screening
* Elective arterial revascularization with in the past month
* Any planned arterial revascularization
* Body mass index \<18 or \>45
* Clinically significant ECG that may interfere with the interpretation of serial ECG and QT interval changes at screening
* Chronic kidney disease defined by estimated glomerular filtration rate of less than 30 mL/mim/1.73m2
* Triglycerides greater than 500 mg/dL, LDL-C greater than 160 mg/dL, or HDL-C greater than 60 for males, or 65 for females
* Clinically significant vital sign abnormalities
* Genetic disorder of cholesterol metabolism
* History of overt liver disease
* Poorly controlled endocrine disorder (Diabetes or Thyroid disorder)
* Current or recent use of systemic corticosteroids
* Recent or ongoing infection or febrile illness
* History of active malignancy within 5 years
* History of alcohol or recreational substance abuse in the past 6 months
* Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 6 months prior to screening or within 5 half-lives of an investigational agent or biologic, whichever is longer.
Nursing Teleconsultation for Patients With Heart Failure

The incidence and prevalence of heart failure are increasing and represent a large portion of hospitalizations in Brazil, are also associated with high rates of morbidity, mortality and costs for the service of health. Such data, added to the current scenario of the pandemic caused by COVID-19, reveal the need for changes in clinical practice, so that health care is more effective and cost-effective and reaches patients without exposing them to risks. Thus, the application of nursing interventions through of telephone technology, which has strong evidence of effectiveness found in the literature, has become an alternative for the implementation of clinical interventions. Objective: Evaluate the effectiveness of nursing consultations performed remotely in improving quality of life and adherence to therapy of patients with HF due to cardiomyopathy of different etiologies. Method: The study will have as methodological framework the randomized clinical trial, with the recruitment of 60 volunteers with a diagnosis of chagasic HF, Hypertensive or Idiopathic, who are monitored at the outpatient clinic of Clinical Unit of Cardiomyopathies and Aortic Diseases or Clinical Unit of Hypertension, InCor-HCFMUSP, included by drawing lots into two groups. group A (n=30) will be monitored in biweekly nursing consultations by a period of three months added to the outpatient follow-up, and group B (n = 30) will follow the usual outpatient follow-up. Hypothesis: Patients HF carriers who periodically make telephone consultations of nursing have better quality of life and better therapeutic adherence when compared to patients who only have regular follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients already registered in a database of the Clinical Unit of Cardiomyopathies and Aortic Diseases, InCor - HCFMUSP and Clinical Hypertension Unit - HCFMUSP, in outpatient follow-up for more than a year;
* Stroke Volume \< 40% and \>25%

Exclusion Criteria:

* Patientes with Pacemaker, Defibrillators, Implantable and Cardiac Resynchronization Therapy
* Listed in heart transplant queue
* Not having technological devices that allow the teleconsultation to be carried out
* Psychic inability to understand the questionnaires and answer the questions asked by the interviewer
Neuropsychology of Financial Capacity

The present project aims to investigate the financial capacity in patients diagnosed with Parkinson's Disease or parkinsonism, brain tumor (glioma or meningioma) and cerebrovascular lesion (stroke), in order to evaluate the presence and degree of impairment, and the role of some factors as potential predictors of financial incapacity.

The term 'financial capacity' means both operations relating, for example, to asset management or investing money, and activities of daily life such as shopping or using small sums of money; these activities are mediated by different cognitive functions, from numerical and arithmetic skills to decision making. Financial capacity is, in fact, an instrumental activity of daily life (i.e. Instrumental Activity Of Daily Living, I-ADL) whose impairment negatively affects the functional autonomy of the individual, so as to be subject to legal protection.

To assess financial capacity, the Numerical Activities of Daily Living - Financial (NADL-F; Arcara et al., 2017) will be administered, a battery of tests aimed at investigating both financial performance and financial competence according to the most recent neuropsychological models proposed in the literature.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* Clinical diagnosis of interest for clinical groups
* For stroke patients: disease duration \> 1 month

Exclusion Criteria:

* Other brain disorders different from those of interest
* Sensory-motor deficits that could prevent neuropsychological assessment
* Language disorders that could prevent neuropsychological assessment
* Global cognitive impairment as indexed by MoCA \< 26 or MMP \< 22.85
Feasibility of an Online Modeled Exposure in Spider Fearful Individuals

The effectiveness of an optimized group exposure treatment is investigated in spider-fearful individuals. Participants will undergo an optimized standardized exposure treatment. After receiving information about the treatment and the phobic stimulus (spider) through a psychoeducation video, participants will observe an exposure treatment of another fearful person, either live or by watching a movie of an exposure treatment online. Subsequently, participants will undergo a live in vivo exposure treatment conducted in a group setting. The effectiveness of the treatment is measured by symptom improvement according to online behavioral avoidance tests and subjective ratings immediately after training and one week later.

The treatment of various anxiety disorders often involves exposure therapy. However, a considerable number of patients do not benefit or experience a resurgence of anxiety following successful treatment. Vicarious safety learning (i.e., modeled exposure) presents a promising avenue to improve therapeutic outcome. Previous evidence indicates that vicarious safety learning can diminish previously acquired fear associations, thereby reducing behavioral avoidance. While single-session interventions have implemented modeled exposure, specific mechanisms of observational learning have not been extensively investigated. Due to high dropout rates in specific phobias, modeled exposure could be utilized as an additional treatment method, potentially yielding better outcomes trough additional learning experience.

This study aims to investigate the applicability of observational learning and its sustainability through mental retrieval cues. Specifically, the study is going to assess the feasibility of modeled exposure conveyed either live or online via video, offering a practical approach within a stepped-care framework. The modeled exposure treatment will be followed by a group exposure treatment to assess the influence of modeled exposure in spider-fearful individuals.

Physically healthy spider-fearful individuals will be either treated with an online or live modeled standardized exposure followed by a group exposure treatment. Half of the participants will receive a mental retrieval cue before the group exposure treatment one day after the modeled exposure treatment. The research aims to determine if long-term reduction of spider fear is achievable through online modeled exposure via video compared to in-person modeled exposure.

Eligibility Criteria:
Inclusion Criteria:

- Elevated score on Spider Phobia Questionnaire (SPQ) \>= 17

Exclusion Criteria:

* Severe allergies to bees/spiders/insects
* Current psychiatric/psychotherapeutic treatment
* Past psychotherapeutic/psychiatric treatment due to anxiety problems
* Current or past psychotic symptoms
* Current suicidal intent
* Experience with exposure-based treatment
* Current psychopharmacological medication
* Severe respiratory, neurological or cardiovascular diseases
Global Congestive Heart Failure Registry

Heart failure (HF) is a major health problem worldwide but there is no global HF study that documents demographics, socioeconomic and clinical factors, diagnostic and management patterns, etiology, biomarkers, co-morbidities, treatments, quality of life, barriers to care and outcomes in all parts of the world. Such knowledge is essential in the prevention and treatment of this global disease. The Global Congestive Heart Failure Registry (G-CHF) is a global registry of approximately 20,000-25,000 HF patients enrolled over approximately 5 years to study these risks and causes of HF.

The G-CHF Registry is a prospective global cohort study of approximately 20,000-25,000 HF patients enrolled over approximately 5 years. Baseline data will be obtained on demographic and socioeconomic data, clinical and laboratory variables, co-morbidities, biomarkers, echocardiography, HF causes, medication use, management patterns, quality of life, and health systems. Six-month, 12-month, 18-month and 24-month follow-up data will be obtained to document patient outcomes and factors associated with outcomes.

A sub-study of approximately 4000 patients (a subset of the main study population) will be performed to measure frailty, cognitive and lung function, mental health, medication adherence, patient-reported barriers to care, dietary assessment, and collection of blood and urine samples for central storage and analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age with a clinical diagnosis of HF seen in outpatient clinics or inpatient hospital wards of the participating centres.
* Written informed consent

Exclusion Criteria:

* Patients considered unreliable by the investigator concerning the requirements for follow-up visits.
Safe & Easy Environment at Home for Patients Presenting a Frail Syndrome

All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.

Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.

The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.

The SafEE project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance, training interface based on Kinect sensor...) .

The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

The non pharmacological therapeutic will be install at patient's home :

* aromatherapy,
* music therapy,
* cognitive training in multimedia application offering cognitive games.

Also smart phone will be given to the patient :

* to help him move with a geolocation application,
* to remind him of his daily needs (shopping lists, people to call, etc ...) with an alert apllication.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age ≥ 60 years with memory complaint
* Score at the Mini Mental Test (MMSE) ≥ 26.
* Score at the Clinical Dementia Rating Scale (CDR) ≤ 0.5.

Exclusion Criteria:

* Sensory defect (visual or olfactory) preventing the patient to perfectly meet therapeutic solutions.
* Prescription new psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment.
* Subject epileptic.
* Subject vulnerable
Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial

The objective of this international, multicenter, randomized study is to assess whether coronary artery stenting is associated with a reduced infarct size in patients with AMI presenting between 12 and 48 hours after onset of symptoms compared to medical treatment alone

Between 8.5% and 40% of patients with acute myocardial infarction present late after symptom onset, no longer being eligible for thrombolysis.Despite efforts to reduce time to presentation, recent studies have demonstrated that time-to-arrival has not changed.The lack of efficacy of thrombolysis in patients with acute MI presenting \> 12 hours after symptom onset may be a reason why current guidelines oppose reperfusion therapy in this setting.Several findings suggest, however,that reperfusion therapy may be beneficial even among these patients. First, recent studies have shown that viable salvageable myocardium exists even after \>12 hours of severe ischemia. Second, previous studies have not only demonstrated that PCI is better than thrombolysis in patients with acute MI,but also that the time window of efficacy for PCI may be wider than that for thrombolysis.Third, observational studies suggest that PCI is effective even when performed after 12 hours from symptom onset in patients with acute MI. The goal of our trial was to assess whether an invasive strategy based on PCI with stenting is associated with reduction of infarct size in patients with acute STEMI presenting \> 12 hours after symptom onset compared with a conventional conservative treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

* patients fulfilling the criteria of AMI and presenting at the hospital between 12 and 48 hours after onset of symptoms. The criteria of AMI are fulfilled when at least one episode of typical chest pain lasting ≥ 20 minutes is combined with either unequivocal ECG changes (≥ 0.1 mV of ST-segment elevation in ≥ 2 limb leads or ≥ 0.2 mV in ≥ 2 contiguous precordial leads or new pathological Q-waves) or CK plus concomitant CK-MB increase above twice the upper normal threshold. All patients have to be informed of the nature of the study and should give their informed consent for participation in the study.

Exclusion Criteria:

* Age \<18 years and \> 80 years
* Cardiogenic shock (systolic blood pressure \< 80 mm Hg unresponsive to fluids or necessitating the infusion of catecholamines: GUSTO I criteria)
* Persistent severe chest pain
* Prior thrombolysis (for index AMI)
* Malignancies with life expectancy \< 1year
* History of bleeding diathesis, coagulopathy
* Contraindications to the antithrombotic therapy used in conjunction with coronary stenting (clopidogrel and abciximab)
* Stroke within the past 3 months
* Major surgery within the past 30 days
* Platelets \< 100000/mm3 or \>700000/mm3, Hb \< 10g/dl, white blood cell count \<3000/mm3
* Percutaneous coronary intervention within the past 30 days
* Inability to cooperate with study procedures and/or follow-up
* Previous enrollment in this trial
A Real-World Assessment of the Demographic, Clinical Characteristics and Outcomes of a Brazilian Cohort of Previously Untreated Extensive Stage-Small Cell Lung Cancer Receiving Durvalumab Combined With Platinum-Etoposide in (ES-SCLC) in Brazil

The central objective of this study is to characterize the demographic of an ES-SCLC Brazilian cohort treated with durvalumab. Secondarily, to assess the outcomes of durvalumab-based regimens in 1L treatment of ES-SCLC Brazilian patients from the private health care setting.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented diagnosis of ES-SCLC (newly diagnosed patients, as well as limited stage relapsed patients, are eligible);
* Have been treated with a durvalumab-based regimen for 1L ES-SCLC in the past (retrospective) OR is currently being treated with a durvalumab-based regimen for 1L ES-SCLC (prospective);
* Male or female adult patients ≥ 18 years of age (as per local Durvalumab approved label);
* Provision of consent in a signed informed consent form (ICF) (allowing for data to be captured from existing medical records). If the patient´s data is entirely retrospective (i.e., the patient already presented progression, death, or completed 18 months of durvalumab-based treatment), the ICF may be waived, as decided by the local ethics committee.

Exclusion Criteria:

* Since the study is observational, there are no Exclusion Criteria. If the patient meets all the Inclusion Criteria, he/she will be eligible for the study.
A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training

The purpose of this study is to determine whether the combination of low frequency repetitive transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface (BCI) training is effective for enhancing motor recovery after stroke.

The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rTMS and BCI training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.

The goal of the present study is to develop and evaluate a brain based approach to improve motor recovery after stroke, by combining rTMS and BCI training. Treatments will consist of low frequency rTMS applied to the contralesional hemisphere, followed by BCI training to encourage activity within the lesioned hemisphere. The primary objective of this study is to test the main hypothesis above in a stroke patient population. Subjects will also undergo a period of BCI only treatments after completion of the combined rTMS and BCI portion.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* Cortical or subcortical stroke with isolated unilateral motor paresis
* At least 3 months but no greater than 12 months post stroke and in stable conditions as judged by patient's physician
* Impaired hand function compared to nonparetic side but at least 10 degrees of active finger extension
* Able to ambulate at least 50 feet with minimal stand-by assistance
* Upper Extremity Fugl Meyer (Fugl-Meyer et al., 1975) score of greater than or equal to 20 out of 66
* Beck Depression Inventory (Beck et al., 1961) less than or equal to 19 out of 63
* Mini-mental State Examination score (Folstein et al., 1975) greater than or equal to 24 out of 30
* Must have an ipsilesional motor-evoked potential (MEP) in response to TMS
* Must be stable outpatients currently undergoing rehabilitation consistent with the current standards of care
* Must be able to communicate clearly in English
* Must be able to provide consent in writing.

Exclusion Criteria:

* Personal history of epilepsy or seizures within the past 2 years
* Previous surgical procedure to the spinal cord
* Any MRI incompatible devices
* Pregnancy
* Claustrophobia
* Breathing disorder
* Hearing problems or ringing in the ears
* Bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
* Cognitive deficits, other non-motor neurological impairment, bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
Effects of Motive-Oriented Therapeutic Relationship in the Early-Phase Treatment of Borderline Personality Disorder

The present research aims at examining the effectiveness of a specific set of therapist relational interventions and attitudes, called the Motive-Oriented Therapeutic Relationship (MOTR), based on Plan Analysis (Caspar, 2007) in the early-phase treatment of patients diagnosed with Borderline Personality Disorder.

The investigators intend to include N = 80 outpatients diagnosed with Borderline Personality Disorder, consulting at the Outpatient Personality Disorder Program of the Karl Jaspers Clinical Unit, in collaboration with the Institute of Psychotherapy, at the Department of Psychiatry-CHUV, University of Lausanne and in collaboration with the University of Berne, Switzerland. Patients are assigned by chance to two treatment conditions 1) Control condition (General Psychiatric Management; Gunderson \& Links, 2008) and 2) MOTR-condition. The investigators hypothesize better results in the MOTR-condition, as compared to the control condition in terms of symptom reduction pre-post.

The conduct of the study represents a significant contribution to the understanding and enhancement of relationship aspects in the treatment of patients diagnosed with Borderline Personality Disorder which may be of potential benefit for these patients.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Borderline Personality Disorder;
* between 18 and 65 yrs of age

Exclusion Criteria:

* DSM-IV psychotic disorders,
* mental retardation,
* substance abuse in the forefront