cyrilzakka/clinical-trials huggingface dataset:
Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

This study is conducted to assess the efficacy and safety of stem cells as adjunctive treatment for severe COVID-19 patients. Here, we want to study whether the administration of mesenchymal stem cells are safe and able to relieve some of the COVID-19 symptoms

This is a randomized controlled trial. double-blind, multi-center clinical study conducted at three different hospitals, on 21 patients who received intervention and 21 patients who received control treatment. The purpose of this study is to evaluate the efficacy and safety of intravenous administration of normoxic allogeneic umbilical cord-derived mesenchymal stem cell (UCMSC) in the treatment group, compared to the control group who are only given standard COVID-19 treatments and normal saline infusion

Eligibility Criteria:
Inclusion Criteria:

* Man or woman age 18-75 years
* SARS-CoV2 positive as confirmed by SARS-CoV2 RT-PCR Test
* Diagnosed with pnumonia as confirmed by chect radiography and history of fever, coug with one of the following symptoms: RR \> 30x per minute, SaO2 93%, FaO2/FiO2 300 mmHg
* Voluntarily joined the clinical trial and has signed the informed consent form

Exclusion Criteria:

* Pregnant and lactating woman
* Patient who are diagnosed or have history of tumor and cancer
* Patient whose mother or sister are diagnosed with breast or ovarian cancer
* Level of SGPT/ALT is ≥ 5 times upper limit from normal value
* Level of eGFR is \< 30 ml/min
* Reluctant to sign informed consent and unwilling to take the required tests
* Require invasive ventilation
* Shock
* Organ failure
* Currently involve in other clinical trial, or join another clinical trial in the last 3 months
Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19

This before-and-after study aims to evaluate the usefulness and efficacy of a personalized computerized cognitive training (CCT) to improve cognitive function among people with post-acute sequelae of COVID-19 (PASC).

Through an online platform created for the study, adults who self-reported cognitive impairment more than 3 months after receiving a COVID-19 diagnosis will be enlisted and their cognitive status will be assessed using a commercially available test. After determining their level of general cognitive dysfunction, those who qualify and meet the inclusion criteria will be invited to use a customized computerized cognitive training (CCT) program at home and to complete as many daily training sessions as they would want over the course of eight weeks. The sessions will consist of gamified cognitively demanding exercises that target five cognitive skills: attention, coordination, memory, perception, and reasoning. Participants will also complete the general cognitive function assessment at the end of the intervention period, and the differences between the cognitive scores obtained before and after this period will be used as the main outcome measure. Additional analysis will be performed to better characterize the impact of the CCT by exploring the role of the age of the participants, their self-perceive health at baseline, the intensity of the training and the time from initial COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Adults (older than 18 years old).
* History of infection with COVID-19 at least 3 months prior to expression of interest.
* Presence of self-perceived cognitive dysfunction associated with PACS (concentration problems or brain fog).

Exclusion Criteria:

* Completion of less than 10 training sessions.
* Not completing the final evaluation after the 8-week training period.
Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease

The purpose of this study is to determine whether daily treatment with this new treatment approach, called COT would be effective in protecting the memory and brain regions of people who are already showing signs of memory loss.

Alzheimer's disease process starts in parts of the brain used for perceiving and interpreting smell many years before people begin to lose their memory and other cognitive functions. These parts of the brain are called the "olfactory regions." From these olfactory regions, Alzheimer's disease spread to involve other parts of the brain. Scientists have shown that stimulating the olfactory regions through exposure to multiple naturally occurring essential or plant oils help to reduce the brain changes of Alzheimer's disease in animals. Also, many components from these plant oils have been shown to protect nerve cells from various kinds of stress and injuries; and we say they are 'neuroprotective'. A novel home-based olfactory chemosensory stimulation program that uses a portable, programmed, device known as the Computerized Olfactory Training (COT) program, administers olfactory psychophysical tasks while patients are being stimulated repeatedly with neuroprotective olfactory stimulants, using neuroscience-guided stimulation parameters to ensure sustained activation of all primary and secondary olfactory structures.

Eligibility Criteria:
Inclusion Criteria:

1. Age 55-95 years; female must be post-menopausal for ≥ 2 consecutive years
2. Probable mild AD according to the core clinical criteria outlined in the National Institute on Aging/Alzheimer's Association (NIA-AA) Guidelines
3. MMSE score between the range of 21 to 27; CDR score of 1.0 (mild AD); scores on Logical Memory II subscale (Delayed Recall) from the Wechsler Memory Scale-Revised (WMS) within the recommended education-adjusted ranges
4. Have either cerebrospinal fluid (CSF) Aβ42 levels that are consistent with Alzheimer's disease as measured via mass spectrometry by C2N, or document elevated amyloid burden consistent with Alzheimer's disease from positron emission tomography (PET) imaging
5. Screening MRI without evidence of infection, infarction, or other focal lesions of neurological disease; and no significant nasal disease.
6. All participants must have a study partner with normal cognitive function.

Exclusion Criteria:

1. Any significant neurologic disease
2. Major psychiatric disorder within the past 2 years
3. Substance use disorder within the past 2 years
4. Any unstable medical condition
5. Contraindications to MRI
6. Any Alzheimer's disease modifying therapy (DMT) in the past 6 months
7. Antipsychotics, anticholinergics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications and blood thinners, except for aspirin at a prophylactic dose or less.
Exploring Mechanisms of Massed Cognitive Processing Therapy

The overall goal of this randomized controlled trial with partial crossover is to compare the effectiveness of 1-week virtual massed Cognitive Processing Therapy (CPT) to 5-day virtual relaxation training (RT) with regard to their ability to reduce posttraumatic stress disorder (PTSD) symptoms. Specifically, this study is designed to 1) examine changes in PTSD symptoms during and following the respective intervention, and 2) explore possible psychological treatment mechanisms, including cognitive control, inhibition, self-efficacy, and memory, and 3) examine possible moderators of treatment success (e.g. neuropsychological factors).


Eligibility Criteria:
Inclusion Criteria:

Are fluent in English

* Have experienced a Criterion A traumatic event during their lifetime
* Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM
* Are interested in receiving evidence-based treatment (CPT) for PTSD and able to attend either 10 therapy sessions over the course of one week (5 days) or are interested and able to complete 5 relaxation training sessions over the course of one week (5 days)
* Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
* Reside in the state of Illinois during the course of treatment

Exclusion Criteria:

1. The traumatic event occurred in the past month
2. They are currently suicidal or homicidal (i.e., plan and intent)
3. They have unmanaged psychosis or mania
4. They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment
5. They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 3 months or are currently receiving an evidence-based PTSD treatment
6. They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in CPT
7. They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
8. They have an active substance use disorder (within the past 3 months) that would require immediate medical observation if substance use was discontinued (i.e., potential lethality)
9. They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
10. They have a visual or auditory impairment that would prevent them from fully participating in study activities
11. Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect the ability to deliver the intervention with fidelity
Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy Volunteers

The objective of the study is to compare the relative bioavailability and pharmacokinetics of solifenacin succinate suspension versus tablet.

All subjects will participate in each treatment separated by a minimum (=\> minimum) of 13 days between dosing.

In the two fasting periods, each subject will receive solifenacin succinate orally in each treatment period following a minimum 10 hour fast from food and beverages. In the fed condition, each subject will receive the suspension within 30 minutes of the start of breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject weighing at least 45 kg with a Body Mass Index (BMI) of 18-32 kg/m2, inclusive
* If female, subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control and is not lactating or pregnant
* Medically healthy, with a normal 12-lead electrocardiogram (ECG)
* Good venous access in both arms

Exclusion Criteria:

* History of any clinically significant disease or malignancy excluding non-melanoma skin cancer
* Known hypersensitivity to VESIcare® or any of the excipients in the formulations, or a history of severe allergic or anaphylactic reactions
* History of alcoholism or substance abuse within past 2 years
* Has used tobacco-containing products and nicotine or nicotine containing products within six months
* Supine mean systolic blood pressure \< 90 or \> 160 mmHg and a mean diastolic blood pressure \< 50 or \> 90 mmHg, or pulse rate \< 40 or \> 100 beats per minute
* Positive test for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
* Known positive for human immunodeficiency virus (HIV) antibody
* Clinical laboratory tests outside the normal limits
* Treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the-counter medications, with the exception of oral contraceptives, hormone replacement therapy, and occasional use of acetaminophen within 14 days prior to Day 1
* Inability to abstain from alcohol or caffeine use for 48 hours prior to the administration of the first dose of study drug and throughout the duration of the study or from grapefruit, Seville oranges, star fruit, or any products containing these items from 72 hours prior to the administration of the first dose of study drug and throughout the duration of the study
* Donated one unit of blood or more, has had significant blood loss, or received a transfusion of any blood or blood products within 60 days or has donated plasma within 7 days prior to study check-in
* Any clinically significant history of gastrointestinal symptoms such as nausea, abdominal discomfort or upset, or heartburn in the four weeks prior to study check-in or a history of any gastrointestinal surgery except for appendectomy or cholecystectomy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects

The study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days in order to allow for including Japanese subjects in future global studies. A cohort of Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by digital ECGs (dECG) recordings, also in Caucasian subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy man or woman
* Body mass index between 18 and 29.9 kg/m2, inclusive

Exclusion Criteria:

* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract
* Any surgery on the small intestine or colon, excluding appendectomy
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk to the subject.
A Study of TAS-303 in Female Patients With Stress Urinary Incontinence

The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.

This study is double-blind, placebo-controlled crossover study. The main purpose of this study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence patients who will receive single dose of TAS-303 or Placebo.

Eligibility Criteria:
Key Inclusion Criteria:

* Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
* Patient weights at least 45 kg and has body mass index (BMI) range of 18.0-30.0 kg/m2, inclusive, at screening
* Patient is positive in 1-hour pad weight test at screening
* Patient has at least 2 incontinence episodes per week.

Key Exclusion Criteria:

* Patient has predominant or primary urge incontinence according to investigator judgment
* Patient had a prior surgical SUI treatment
* Patient is diagnosed Pelvic Organ Prolapse
* Patient is currently taking medication, or has taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergic or anti-histamines or any anti-anxiety medications.
* Patient is positive pregnancy test
Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke

To determine the effects of action observation treatment on motor functions in upper limb of patients with chronic stroke

Stroke is one of the major cause of death in Pakistan and also a prime source of disability in older adults.Mirror neuron system depends on motor regions, and its dominant aspect is that,it is activated for implementation of motor activity and also for its observation. This "dual activation" characteristic of mirror neuron helps in improving the observation and execution of different actions.

aim of this study is to determine the effects of action observation treatment on motor function in upper limb of patients with chronic stroke.

An RCT will be conducted on 14 chronic stroke patients from Omar Hospital and Riphah Rehabilitation Centre Lahore. Patients will be randomly allocated into control group (n=7) and Experimental group (n=7) by lottery method. Control group will be given only conventional treatment that included stretching, strengthening, pinching, gripping, reaching and grasping exercises, while Experimental group received conventional treatment and action observation treatment 3 days/ week for 4 weeks. Treatment outcomes will be assessed on Modified Barthel Index and Fugl-Meyer Assessment for upper extremity (FMA-UE)

Eligibility Criteria:
Inclusion Criteria:

* Chronic Stroke patients (with more than 6 months- 4 years) illness
* Patients that were able to communicate and comprehend oral instructions
* Patients with Mini Mental State Examination (MMSE) score more than 24

Exclusion Criteria:

* Patients having psychiatric histories.
* Visual and hearing impaired patients
* Patients with speech impairment
* Patients with arthritic deformities in upper limb (with or without using assistive device)
* Patients with diagnosed mental illness.
Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease

TRICOLON is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the Netherlands. The primary objective is to investigate in COPD patients if single-inhaler triple therapy (SITT) is superior to multi-inhaler triple therapy (MITT) in terms of adherence to inhaled corticosteroids (ICS) therapy and to investigate if SITT with e-health support is superior to MITT and SITT without e-health support.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD for at least 1 year before the screening visit
* Aged 40 years and older
* An indication for triple therapy according to the treating physician (following the GOLD guideline 2021(2)). Could be step-up from dual therapy or currently receiving triple therapy (both MITT and SITT).
* Owner of mobile device compatible with e-device app with access to internet (Android or iOS)
* Willing to provide written informed consent
* Current or ex-smoker

Exclusion Criteria:

* Inability to comply with study procedures or with study treatment
* Insufficiently skilled in the Dutch language to be able to read and understand the app. Help by third party (family members) is allowed
* Asthma as the predominant disease according to the investigator's opinion, a past history of asthma is allowed
* Use of e-health application for COPD in the past six months
* Patients with any other therapy that could interfere with the study drugs (according to the investigator's opinion)
* Use of nebulized bronchodilators, for example via pari boy
* Pregnant or lactating women and all women physiologically capable of becoming pregnant unless they have highly effective contraceptive
* Patients mentally or legally incapacitated, or patients accommodated in an establishment as a result of an official or judicial order
* Patients without the capability to complete the questionnaires
Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction

The purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.

No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. This prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute myocardial infarction
* Vessel TIMI flow \< grade Ⅲ post-PCI

Exclusion Criteria:

* Heart failure of New York Heart Association (NYHA) class Ⅲ to class Ⅳ
* Sick sinus syndrome
* Atrioventricular block (grade Ⅱ and above)
* SBP ≤ 90mmHg or cardiogenic shock
* Heart Rate ≤60 bpm
* Pregnancy
* Renal or hepatic failure
Hearing Impairment, Cognitive Therapy and Coping

A randomized controlled study with hearing impaired workers, who have voluntarily signed up for an 8 session cognitive therapy (CBT) course The CBT intervention will be compared to a waiting list control group. Participants who are allocated to the intervention group will be offered to start on the CBT-course immediately, while the control group that will be offered the same course 12 months later. Main outcome measures are assessments of mental distress and vocational coping. We will also assess the distress associated with tinnitus, which is a potential moderator variable.

Although the relationship between hearing loss and mental distress is not linear, it is known that hearing impaired individuals have increased vulnerability for development of symptoms of distress and fatigue. It is assumed that distressed hearing impaired individuals will have a tendency to use maladaptive and passive coping strategies, such as social withdrawal or reluctance to make use of hearing aid devices. On the other side, it is well documented that hearing impaired employers who are open about their handicap and make others aware of their situation, i.e. take an active coping approach, have fewer symptoms of distress and have better vocational functioning. The level of knowledge is limited and mainly based on cross sectional studies, and the way people cope with hearing impairment has been measured indirectly by questionnaires focusing on communication problems. We plan to conduct a randomized controlled study with hearing impaired workers, who have voluntarily signed up for an 8 session cognitive therapy (CBT) course The CBT intervention will be compared to a waiting list control group. Participants who are allocated to the intervention group will be offered to start on the CBT-course immediately, while the control group that will be offered the same course 12 months later. Main outcome measures are assessments of mental distress and vocational coping. We will also assess the distress associated with tinnitus, which is a potential moderator variable.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants need to be within the age range of 18-70 years, contain some formal employment and be able to document a mean, bilateral hearing loss of at least 40 dB.
* Eligible participants need to have a HAD score of 7 or beyond

Exclusion Criteria:

* Individuals without a clear vocational status (for instance on permanent/temporarily sick leave) and a mean bilateral hearing loss beneath 40 dB.
* Individuals with a HAD score beneath 8 are excluded.
Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation

The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation.

A single center, prospective cohort study


Eligibility Criteria:
Inclusion criteria:

* Age 18- 85 years
* Patients with severe degenerative mitral regurgitation undergoing mitral valve repair at our institution

Exclusion criteria:

* Functional or ischemic mitral regurgitation
* Presence of relevant (symptomatic) Coronary Artery Disease
* Inability of exercising on semi supine bicycle