cyrilzakka/clinical-trials huggingface dataset:
A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19

The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).


Eligibility Criteria:
Key Inclusion Criteria:

* Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 90 days following the vaccine administration.
* Part 1: Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants ≥18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable.

Part 2: No prior vaccination is required. For participants who have been previously vaccinated, proof of vaccination is required.

Key Exclusion Criteria:

* Has had close contact, as defined by the Centers for Disease Control and Prevention (CDC), with someone who had a SARS-CoV-2 infection in the past 14 days, or COVID-19 in the past 10 days.
* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 181 days prior to Screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Has received or plans to receive any licensed vaccine ≤60 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 60 days after the study injection.
* Has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study.
* Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
* Has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Note: Other inclusion and exclusion criteria may apply.
Water Versus Land Based Perturbation Exercises in Elderly Participants With Back Pain

The aim of this study was to compare the effectiveness of land based versus water based perturbation exercises on the pain, disability, fear of falling, and fear avoidance beliefs in elderly participants. Overweight/obese subgroup was compared with healthy weight with chronic low back pain participants to investigate any effect on BMI on both interventions. The results of the study revealed that both exercise groups i.e., land and water based exercise had a significant reduction in pain level, fear of falling, fear avoidance belief related to work, disability and improved SLR.

Twenty-four grouped into 12 per group participated water based and land based exercise protocol. Both groups were given McKenzie Method of exercises in 1st week based on the treatment-based classification (TBC) approach or personalized to the need of participants as per TBC.

Perturbation-based postural exercises were given to participants, which were performed on land or water for 6 weeks.

The perturbation based exercises were categorized into four levels, where level 1:static postural control, 2:dynamic postural control 3:Extremity loaded postural control and 4: cognitive task associated postural control. The perturbation were provided at shoulder and hip level, by intervention providers progressive enough to initiate anticipatory or compensatory postural adjustments.

Both groups were educated on pain assurance and spinal ergonomics feedback. The Outcomes were measured using a Visual analog scale, Oswestry disability index, Fear avoidance belief questionnaire, Straight leg raise, Modified fall efficacy scale, and Borg scale. The pain level were assessed for personalized progression from level 1 to level 4 progression of perturbation exercises.

Both the exercise groups of land and water showed improvement in measured clinical outcomes in terms of reduction in pain level, fear of falling, fear avoidance belief related to work, SLR, and disability. Water-based group showed additional benefits and significant improvement in fear avoidance belief related to physical activity and exercised with low rate of perceived exertion.

Eligibility Criteria:
Inclusion Criteria:

* Pain history of minimum 12 weeks duration in below labels
* Participants with the diagnostic labels of spondylosis
* Non-specific chronic low back pain
* Back pain radiating to leg or sciatica
* Subacute back pain

Exclusion Criteria:

* Unstable blood pressure
* Cardiac failure
* Incontinence
* Uncontrolled epilepsy
* Open wounds
* Acute infections
* Neurological disorders
* Orthopedic conditions affecting exercise participation in pool and land
* Cardio-respiratory conditions affecting exercise participation in pool and land.
Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

Aim of the FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.

Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor-α, and c-kit. The trial of comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS) was an international randomized Phase III study designed for registration purposes. This trial randomized 723 metastatic renal cell carcinoma patients with any prognostic features to axitinib or sorafenib in the second-line setting and demonstrated significant clinical benefit of axitinib.

Aim of present FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.

Eligibility Criteria:
Principle Inclusion Criteria:

* Histologic confirmation of Renal cell carcinoma with a clear cell component
* Patients must have measurable disease
* Previous treatment with sunitinib or pazopanib
* Favorable prognosis according to IMDC criteria
* Must have available tumor tissue for submission
* Subjects must also meet various laboratory parameters for inclusion
* Patients must give written informed consent prior to initiation of therapy

Exclusion Criteria:

* Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events
* Patients who have history of uncompensated diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation in ARDS Patients by EIT

Effects of airway pressure release ventilation on pulmonary ventilation, shunt and perfusion in patients with ARDS

Effects of airway pressure release ventilation on respiratory mechanisms including ventilation distribution, intrapulmonary shunt and V/Q match in lungs of ARDS evaluated by EIT at different time points.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old \< age \< 80 years old
2. Diagnosed as moderate or severe ARDS according to the Berlin 2014 definition
3. Predicted APRV mechanical ventilation for more than 72 hours

Exclusion Criteria:

Excluded if any of the following exclusion criteria are met:

1. APRV contraindications such as pneumothorax, severe chronic obstructive pulmonary disease, severe asthma, intracranial hypertension
2. Pregnant women
3. Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary disease, cardiogenic shock or cardiac hand
4. Refractory shock
5. BMI\>35
Adherence and Quality of Life in People With Schizophrenia and Schizoaffective Disorder

It is the goal of this study adherence and quality of life in a population of people suffering from schizophrenia or schizoaffective disorder and to analyze if these factors are influenced by treatment, support, social services, and residential treatment. The study population is drawn from the the cantons Glarus and Graubunden as well as Liechtenstein.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or schizoaffective disorder
* 18 - 65 years old
* treated in the PDGR within the past 19 years

Exclusion Criteria:

* organic brain disorder
* alcohol or drug dependence
* low intelligence
* unable to give consent
* no legal competency
* lacking knowledge of German language
* current psychiatric inpatient treatment
An Observational Study of Aducanumab-avwa in Participants With Alzheimer's Disease in the US

This is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa as prescribed in the post-marketing setting in the US. Investigators will be prescribing aducanumab-avwa and participants will be treated according to the standard of care (SoC). Participants will be followed up to 5 years after enrollment and data will be collected at routine visits every 6 to 12 months.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has a diagnosis of Alzheimer's Disease (AD) and is prescribed aducanumab-avwa by their treating physician.
* Participant's treating physician has made the decision to initiate aducanumab-avwa prior to participant inclusion and independently of the purpose of the study.

Key Exclusion Criteria:

* Participant concurrently participates in any interventional clinical study.
* Participant has ever been treated with aducanumab-avwa at a dose of 3 milligrams per kilogram (mg/kg) or greater prior to signing ICF.
* Participant has ever been treated with aducanumab-avwa and discontinued treatment prior to signing ICF.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.There is no standard treatment regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic advanced or metastatic adenocarcinoma histologically confirmed.
* Previously treatment with gemcitabine as adjuvant or metastatic disease.
* Clinical or radiological evidence of disease progression, determined by physician. Is not mandatory RECIST (Response Evaluation Criteria in Solid Tumors) evaluation to determine the progression of disease before the study inclusion.
* Patient with intolerance to gemcitabine, even without disease progression, are also eligible.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
* At least 10 weeks of life expectation.
* Adequate organ function defined as:

  * Serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase)≤ 2.5 × ULN (upper normal limit)
  * Total Bilirubin ≤ 2,0 x ULN
  * Absolute neutrophil count ≥ 1,500/ mm3
  * Platelets ≥100.000/ mm3
  * Hemoglobin ≥ 8,0 g/dl
  * Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min
* Signed written informed consent.

Exclusion Criteria:

* Major surgical procedure within 4 weeks of the beginning of the treatment.
* History of serious clinical or psychiatric disease.
* Symptomatic hypoglycemia at the screening visit.
* Target lesion radiotherapy within 4 weeks of the beginning of the treatment.
* Treatment with any anti-cancer investigational drug.
* Treatment with any IGF-I or IGFR-I
* Treatment with metformin within 12 months prior to commencing study treatment
* For female patients, current pregnancy and/or lactation
Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint .

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.

PICO:

Population (P): Patients with symptomatic anterior disc displacement with reduction.

Intervention (I): Michigan splint. Comparator (C): Anterior repositioning splint (ARS) .

Outcome(O):

Primary outcome: Patients' subjective pain experience. Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.

Secondary outcome:

1. Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisors using a ruler.
2. lateral excursion . Assessment of lateral excursion will be performed by measuring the distance in mm between midline of upper and lower jaws
3. protrusion. distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient from 15 to 50 years old.
2. Report of pain in preauricular region worsened by functional activities, such as chewing and talking.
3. Presence of disc displacement with reduction and joint clicking
4. positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI).

Exclusion Criteria:

1. . .
2. History of TMJ surgery.
3. Individuals with osteoarthritis.
4. Individuals under TMD management.
5. Individuals wearing full or partial dentures.
6. Individuals with major psychological disorders.
7. Nonreducing dislocations of the articular disc
8. Consequences of condyle fractures and/or fracture of another maxillofacial zone.
9. Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis, psoriasis arthritis).
10. Individuals with a recent history of trauma in the face and/or neck area. Individuals with systemic diseases that can affect TMJ
Preventive Care of Chronic Cervical Pain and Disabilities

The aim of this study is to determine which of tertiary prevention spinal manipulative therapy (SMT) or a home exercise program is the more efficient approach to reduce pain and increase functional capacity, quality of life and general health condition. To do so, 60 participants with chronic cervical pain, will be recruited and divided into 3 groups according to the intervention they will receive: control group, experimental group 1 who will receive preventive chiropractic care in the form of spinal manipulations and experimental group 2 will have to perform an individualized home exercise program on a daily basis. We hypothesize that a group of patient receiving SMT + a home exercise program will present less pain and functional disabilities over a 1 year period. The innovative value of this project is mainly related to the fact that it will generate new and potentially very useful data concerning the clinical significance of preventive chiropractic care. Moreover, such data will be beneficial to our profession as chiropractic makes a step towards prevention, wellness and public health.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 60 years old from the city and the surrounding Trois-Rivières with chronic cervical pain of non-traumatic origin (chronic or recurrent cervical pain that lasted at least 6 months)

Exclusion Criteria:

Exclusion criteria for the project are:

* Surgery to the cervical spine
* Neoplasms
* Severe osteoarthritis
* Ankylosing spondylitis
* Hypertension
* Referred pain in the cervical area
* Central or peripheric nervous system dysfunction
* Vascular disease
* Treated cardiovascular disease
* Inflammatory or infectious disease of the cervical spine
* Metabolic or endocrine diseases
* Pregnancy
* Specific rehabilitation training for the neck or already under manual therapy for neck pain
* Patient suffering from dizziness, vertigo or headache suspected to be cervicogenic or of unknown origin will not be involved in the study.
Impact of Non Invasive Ventilation on Quality of Sleep

Quality of sleep is profoundly affected in patients with hypercapnic respiratory failure and restrictive disorders, with a decrease in rapid eye movement (REM) and slow wave sleep, and an increase in sleep fragmentation. Assisted ventilation aims at improving blood gases, but may also have a favorable impact on sleep structure. The investigators reviewed polysomnographic and blood gas data obtained between 1987 and 2008 in 95 patients with restrictive pulmonary disorders, before and after implementing non-invasive ventilatory support.

Chart review of all patients with predominantly restrictive pulmonary disorders treated for respiratory failure by NIV at our institution between 1987 and 2008.

Data systematically recorded included pulmonary function tests, diurnal arterial blood gases, and polysomnography before and after implementation of nocturnal NIV.

Eligibility Criteria:
Inclusion Criteria:

* Patients with restrictive pulmonary disorders (neuro-muscular diseases, chest wall disorders, sequellae of tuberculosis) leading to hypercapnic respiratory failure requiring non invasive ventilation (NIV), investigated according to clinical standards in our institution by polysomnography before and after implementation of NIV

Exclusion Criteria:

* Patients fulfilling inclusion criteria for whom diagnostic polysomnography and/or polysomnography under NIV were not performed
Effectiveness of Group and Individual Training in EFT for Patients in Remission From Melanoma

Serious medical diagnosis frequently induce fear focused on specific anticipations or generalized anxiety, along with uncertainty, insecurity, and disorientation. Other emotions such as anger, depression, hopelessness, shame, or grief may also become involved following a serious diagnosis. The adverse impact of stress on health and immune function is well-established, as well as its link to depression and anxiety. Emotional Freedom Techniques (EFT) has demonstrated efficacy in treating anxiety, depression, and PTSD. This study tests its effectiveness in reducing negative emotional symptoms in general, and fear of recurrence in particular, among individuals previously diagnosed with melanoma and currently in remission.

Serious medical diagnosis frequently induce fear focused on specific anticipations or generalized anxiety, along with uncertainty, insecurity, and disorientation. Other emotions such as anger, depression, hopelessness, shame, or grief may also become involved following a serious diagnosis. The adverse impact of stress on health and immune function is well-established, as well as its link to depression and anxiety. Emotional Freedom Techniques (EFT) has demonstrated efficacy in treating anxiety, depression, and PTSD. This study tests its effectiveness in reducing negative emotional symptoms in general, and fear of recurrence in particular, among individuals previously diagnosed with melanoma and currently in remission.

Specifically, the study aims:

1. To assess the effect of instruction and practice of EFT on illness perception, fear of cancer recurrence, and wellbeing.
2. To assess whether the social support provided by EFT instruction in a group setting makes this efficient mode of implementation non-inferior or even beneficial in comparison to personal instruction.
3. To describe the emotions related to life events reported by patients in connection with the appearance and location of melanoma.

Eligibility Criteria:
Inclusion Criteria:

* Melanoma diagnosis over six months prior to the study; confirmed by clinical, dermoscopic examination and pathology results

Exclusion Criteria:

* In active treatment for melanoma
* schizophrenia
* epilepsy
* other malignant disease