cyrilzakka/clinical-trials huggingface dataset:
Escalated Application of Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis Patients

Background: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that selectively affects motor neurons in the brain and spinal cord, leading to bulbar, respiratory, and limb weakness. There is no effective treatment, and the disease usually progresses to death within 2 to 4 years. The therapeutic plasticity of mesenchymal stem cells (MSCs) may be an attractive therapy to this complex disease, turning MSCs strong candidates for cellular therapy in ALS.

Design-A phase 1 open-safety clinical trial. 4 patients will be selected according to a restricted inclusion and exclusion criteria and after 2 escalated infusions of MSCs, there will be a follow up period of one year Methods - Primary endpoint: safety of mesenchymal autologous stem cells infusions escalated in two intrathecal administrations in patients with ALS defined as severe adverse events (SAe). Secondary endpoints: clinical response, laboratorial and magnetic resonance imaging of patients submitted to cellular escalating doses applied in the study. Quality of life, according to El Escorial criteria, ALSFR scale and functional scales.

Conclusion: This study is a primary step before a large randomized double-blind clinical trial for ALS. It is expected to confirm the safety of escalated MSCs therapy in ALS patients, initial data of efficacy in addition to improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Women and males over 18-year-old.
* Diagnosis of ALS in agreement with the criteria of "EL SCORE"
* Less than 24 months of evolution of the disease (from the beginning of the symptoms).
* Good understanding of the protocol and aptitude to grant the informed consent
* Infertile women (post-menopause or hysterectomized)
* Brazilian citizen and permanent resident.

Exclusion Criteria:

* Any significant medical condition (congestive heart failure, angina, respiratory failure, and others)
* Any auto-immune disease
* Any malignant diseases
* Systemic infection
* Mental illness
* Depressive state
Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension

The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18 years old or older.
* Patients with a diagnosis of hypertension defined as follows:

  * Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= mmHg and \< 110 mmHg at Visit 1.
  * All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= 85 mmHg and \< 110 mmHg at Visit 2.
  * All patients must have a msDBP \>= 90 mmHg and \< 110 mmHg at Visit 5.
* Patients who are eligible and consent to participate in the study

Exclusion Criteria:

* Severe hypertension (msDBP \>= 110 mmHg and/or MSSBP \>=180 mmHg).
* Previous or current diagnosis of heart failure.
* History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
* Other protocol-defined inclusion/exclusion criteria may apply
Lethargic Depression Study

This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.

A Multicenter, Double-Blind, Placebo-controlled comparison of the efficacy and safety of flexible dose extended-release bupropion (HCl) 300-450 mg/day and placebo administered for eight weeks for the treatment of adult outpatients with major depressive disorder including symptoms of decreased energy, pleasure, and interest

Eligibility Criteria:
Inclusion criteria:

* Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years.
* Generally in good health.
* Subject must read and write at a level sufficient to provide written informed consent.

Exclusion criteria:

* Current or past history of seizure disorder.
* Subject has a primary diagnosis or received treatment for panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), acute stress disorder, Bipolar I or II disorder, schizophrenia, or other psychotic disorder.
* Currently using illicit drugs or other psychotropic drugs.
* Patient poses a current suicidal risk or has attempted suicide in the past 6 months.
Comparison of Two Types of Bandages in the Treatment of Lymphoedema

The study is a cohort study of patients at the University Hospital during the first two days of intensive treatment. The patients are randomly divided into two groups (N=10).

Throughout the study, group A is treated with the multilayer elastic bandage while group B is bandaged with contention only. The bandages were applied on the first and second day and were maintained in place. The bandages were applied on the first and second day and were maintained for 24 hours. All patients performed 30 minutes of physical activity in the bandage on both days.

The evaluation is based on the volumetric difference, skin quality and quality of life of these patients


Eligibility Criteria:
Inclusion criteria:

* Adult with unilateral lower limb lymphoedema
* Stage 2 or 3 lymphoedema
* 1st intensive decongestant treatment
* Ability to sit on a cycloergometer

Exclusion criteria:

* Severe cardiac disease
* Infectious dermoepidermitis
* Bandage unbearable for the patient
Pre-visit Digital Messaging Improves Patient Reported Outcome Measure Participation Prior to the Orthopedic Ambulatory Visit

Patient-Reported Outcomes Measurement Information System (PROMIS) forms will be administered remotely to consecutive Orthopaedic patients presenting for new physician clinic visits. These patients will be sent either reminder e-mails, reminder digital patient portal ("MyChart") messages, or no reminder messages at all concerning PROMIS form completion at timepoints prior to their respective clinic visits and PROMIS form completion rates will consequently be assessed. The primary objective of this study is to develop an understanding of whether pre-visit reminder messages influence PROMIS form completion in Orthopaedic patients.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* English speaking
* No previous PROM form completion at the healthcare system
* Seeing a respective orthopedic provider for the first time
* Active registration with the electronic medical record (EMR; Epic, Verona, WI) patient portal ("MyChart")
* Valid e-mail address.

Exclusion Criteria:

* Under 18 years old
* Non-English speaking
* Previous PROM form completion at the healthcare system
* Seeing a respective orthopedic provider for follow-up
* No active registration with the electronic medical record (EMR; Epic, Verona, WI) patient portal ("MyChart")
* No valid e-mail address.
Electrostimulation Program for Lung Transplant Recipients in the ICU

This study aims to evaluate rectus femoris muscle mass in lung transplant recipients and the effect of a training program during ICU admission based on the use of electrical muscle stimulation (EMS)

Lung transplantation is so far the only viable therapy for those individuals with a life-threatening chronic respiratory individuals with a chronic respiratory problem that compromises their life in a period of less than two years and the therapeutic options have been exhausted.

The investigators are dealing with individuals with a prolonged disease process, characterized mainly by the reduction of their respiratory capacities, which has a great impact on the basic activities of daily living.

Pulmonary involvement conditions the mobility of the individual, limiting physical activity and leading to episodes of dyspnea.

The aerobic capacity of the patient is very impaired before the transplant, although after the transplant, it continues in levels below normal for their age . This, resulting in episodes of dyspnea impacts on the extraction and utilization of muscular oxygen , which reduces mobility periods.

Limitations in physical activity and even mobility prior to physical activity and even mobility limitations prior to transplantation lead these individuals to marked muscular deterioration, which has an impact on both the general physical and psychological levels.

The aim of this study is assessment of muscle status in transplant recipients in lung transplant recipients after application of EMS therapy in the ICU.The sample is divided into two groups, a control group that will not receive EMS therapy and a control group that receive it.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the lung transplant list according to the criteria of the Health System.
* Those who attend the rehabilitation consultation of the hospital under study to undergo treatment prior to transplantation.
* They must receive the graft at the hospital under study and be admitted to the resuscitation unit at the same center for post-surgical follow-up.

Exclusion Criteria:

* Those who are rejected from the transplant list or deceased before the implant is performed.
* Lack of follow-up by the rehabilitation consultation.
* Are receiving treatment with muscle relaxants after admission to the ICU.
* Present skin alterations incompatible with EMS.
* Contraindications to perform the transplant proposed according to the criteria of the Health System.
A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers

This is a single-centre, open-label, first-in-human, single ascending dose and multiple dose study to assess the safety, reactogenicity, and immunogenicity of the SC-Ad6-1 investigational product when administered via the intramuscular (IM), intranasal (IN) or inhaled (IH) route in healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult males and females, 18 to 60 years of age (inclusive)
* Body mass index ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg at screening
* Must have been fully vaccinated against COVID-19 and received last dose not less than 3 months prior to Day 1 (High Dose #3 I.M. and I.N. booster arms only), not less than 5 months prior to Day 1 (High Dose #4 I.N. booster arm only) and not less than 12 months prior to Day 1 (I.H. booster arms and I.N or I.H. multiple dose booster arms only)

Key Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease
* History of chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent (≤14 days prior to Screening) or ongoing respiratory tract infection
* History of thrombosis (e.g., deep vein thrombosis, pulmonary embolism, etc.), any coagulation dysregulation disorder, or a history of thrombosis noted in immediate family members
* History of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
* Known previous infection with SARS-CoV-2 or presence of antibodies against SARS-CoV-2 or a positive SARS-CoV-2 PCR test (non-booster arms only)
* Any history of malignant disease ≤5 years prior to registration
* History of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia
Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures

The purpose of this study is to determine if cholangioscopically-directed biopsies provide a higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures when compared to standard means of sampling.

Biliary strictures in the absence of a mass are a clinical challenge, as current accepted means of sampling provide suboptimal accuracy. Both biliary brushings for cytology and fluoroscopically-directed biopsies produce highly-variable results. Endoscopic ultrasound with fine-needle aspiration has also been employed with variable results. An additional modality, using a single-operator cholangioscope during endoscopic retrograde cholangiopancreatography (ERCP) to obtain cholangioscopically-directed biopsies offers promise in increasing the yield of sampling. Initial observational studies have shown an improved diagnostic yield, but the technique has not been tested in a randomized, medical effectiveness study to better characterize its actual clinical impact. We aim to compare the technique of biopsy-on-biopsy derived sampling via single-operator cholangioscopy with standard fluoroscopically-directed biopsies and brushings in a pilot study. We also aim to perform a medical effectiveness study on the early use of single-operator cholangioscopically (SOC) in the evaluation of undiagnosed biliary strictures.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Presence of indeterminate biliary strictures with clinical indications for ERCP. Strictures are considered indeterminate when evaluation including cross-sectional imaging is non-diagnostic. Patients who have previously undergone ERCP with sampling will be included, as well as those who have not previously undergone ERCP.
* Strictures located above the intrapancreatic bile duct
* The Subject's physician determines and ERCP is clinically indicated
* Able to provide informed consent

Exclusion Criteria:

* Prior enrollment in the study or another study evaluating biliary strictures
* Presence of extrahepatic malignancy or previously-diagnosed hepatocellular carcinoma
* Pregnancy
* At-risk populations including prisoners and mentally challenged
* Unwilling to provide informed consent
* Medically unfit to undergo ERCP
* History of liver transplant
Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma

The rates of Venous thromboembolism (VTE) after orthopedic surgery are as high as 40-60% without prophylactic measures. Enoxaparin, a low-molecular-weight heparin, produces an anticoagulant effect by binding antithrombin, thereby accelerating antithrombin's inactivation of coagulation factor Xa (FXa), thus decreasing the likelihood of clot formation. Despite standard dosing enoxaparin prophylaxis, VTE rates in post-operative orthopedic trauma patients remain as high as 12.2%.The investigators will examine enoxaparin pharmacokinetics and test whether a clinical protocol for real-time enoxaparin dose adjustment can favorably alter the proportion of patients with in-range anti-Factor Xa (aFXa) levels. Outcomes will include peak and trough steady-state aFXa levels in response to standard and escalated doses of enoxaparin and the incidence of venous thromboembolism and bleeding events post-surgery. In the trauma and orthopaedic populations, patients with low initial aFXa levels are significantly more likely to develop deep venous thrombosis. Thus, this study has important implications for appropriate enoxaparin dose magnitude and frequency, and may ultimately help to decrease the substantial morbidity and mortality associated with post-operative VTE.


Eligibility Criteria:
Inclusion Criteria:

* Receiving orthopedic trauma surgery
* Able to have enoxaparin initiated within 36 hours after procedure

Exclusion Criteria:

* Intracranial bleeding/stroke
* bleeding disorder
* heparin-induced thrombocytopenia
* creatinine clearance \< 30 mL/minute
* epidural catheter
* serum creatinine \> 1.6 mg/dL
What is the Effect of a Course for Treatment Providers on Their Patient Outcome

The goal is to acquire more in-depth knowledge on physical therapists' attitudes towards and beliefs about psychosocial factors in back pain, how physical therapists integrate psychosocial factors into their clinical practice and the effects of a training program for physical therapists in psychosocial factors on clinical practice and thereby on patient outcome in terms of disability, pain, catastrophizing, and treatment satisfaction.

Neck and back pain continue to be extremely common, with a high prevalence and wide socio-economic consequences all over the industrialized world. Through the years a growing interest has risen for other factors than the pure biomedical or biomechanical. This has led to a new clinical model for the treatment of back pain; the biopsychosocial model of illness. Treatment based on the biopsychosocial model not only must address the biological basis of symptoms, but must incorporate the full range of social and psychological factors that have been shown to affect pain, distress and disability.

Since there is today strong evidence indicating that psychosocial factors have a greater impact on disability then biomechanical or biomedical factors and strong evidence that psychosocial factors are strongly linked to the transition from acute to chronic pain, concept of psychosocial risk factors has been developed. Although the concept of psychosocial risk factors still is relatively new, there seems to be an international consensus about the importance of psychosocial risk factors for the prevention of the development of chronic pain but there appears to be considerable uncertainty about the clinical application.

Health care providers' (HCPs') attitudes and beliefs appear to influence the information they provide to patients. This may subsequently result in different patient outcome depending on the HCPs' attitudes and beliefs. Physical therapists attitudes and beliefs are relatively unexplored but seem to have an effect on patients' attitudes and beliefs, which can affect patient outcome in terms of sick leave, health care use and function.

HCP attitudes and beliefs towards psychosocial factors are relatively unexplored. Yet, it seems physical therapists do not necessarily accept new evidence-based information and may have difficulties in applying evidence-based information in their clinical practice. Implementation and dissemination of evidence-based psychosocial factors requires favourable attitudes, knowledge and skills to ensure a behavioural change on behave of the physical therapists.

Eligibility Criteria:
Inclusion Criteria:

* Musculoskeletal pain,
* Age between 18 and 65

Exclusion Criteria:

* Sick leave for more than 3 months during the past year as a result of present the musculoskeletal pain problem
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.


Eligibility Criteria:
Inclusion Criteria:

Main criteria:

* Postmenopausal women (hysterectomized or not)
* Women between 40 and 80 years of age
* Women having ≤5% of superficial cells on vaginal smear at baseline
* Women having a vaginal pH above 5 at baseline
* Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
* Willing to participate in the study and sign an informed consent

Exclusion Criteria:

Main criteria:

* Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
* Previous diagnosis of cancer, except skin cancer (non melanoma)
* Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
* The administration of any investigational drug within 30 days of screening visit
* Clinically significant abnormal serum biochemistry, urinalysis or hematology
A Self-Management Intervention for Mild to Moderate Heart Failure

This study will test whether a self-management (SM) intervention, compared to usual care, will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure.

BACKGROUND:

Heart failure is a major disabling disease for American adults, affecting an estimated 4.9 million individuals. Heart failure is associated with enormous health care expenditures. This is because it is a progressive chronic condition that is characterized by disabling symptoms that limit independence and result in multiple hospitalizations and referrals to long-term care. The emergence of heart failure as a major public health problem is related to the unintended result of both an aging population and the success in reducing mortality from cardiovascular disease. Non-adherence to medications is a key problem in the treatment of heart failure, with adherence rates ranging from 20% to 90%. There is a clear need, therefore, to develop interventions that improve adherence in patients with heart failure.

DESIGN NARRATIVE:

This is a single-site, partially blinded, randomized clinical trial of 900 patients with systolic or diastolic dysfunction, and New York Heart Association (NYHA) functional class II or III. Patients will be recruited over a period of 2 years from seven hospitals. Patients will be randomly assigned to either a SM intervention or attention control. The SM group will meet 18 times for 2 hours over 1 year. These group sessions will teach patients how to use five basic self-management skills (self-monitoring, environmental restructuring, social support, cognitive restructuring, and the relaxation response) to help build self-efficacy and maintain it after the treatment has been discontinued. The attention control arm will consist of an educational intervention which includes 18 mailings of the American Heart Association Tip Sheets over the course of the first year, plus a telephone follow-up with the patient after each mailing to check receipt and comprehension of the Tip Sheet, and to address any questions about the Tip Sheet. Treatment effects will be evaluated using the primary outcome of hospitalization for heart failure or death, and the secondary outcomes of progression of heart failure, quality of life, and health care costs. Potential mediators of effectiveness will include improved adherence and improved psychosocial function.

Eligibility Criteria:
Inclusion Criteria:

* NYHA classification of II or III
* LVEF of 40% or less

Exclusion Criteria:

* Uncertain 12-month prognosis
* Potential cardiac transplant within 1 year of study entry
* Severe aortic stenosis
* Uncontrolled ventricular tachycardia
* Non-cardiac causes of heart failure symptoms (i.e., peripheral vascular disease, chronic obstructive pulmonary disease, and arthritis)
* Major psychiatric co-morbidity
* Unstable angina, myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 1 month prior to study entry