cyrilzakka/clinical-trials huggingface dataset:
Mindfulness Based Cognitive Counseling on Social Anxiety

The aim of the study is to determine the effect of group mindfulness based cognitive counseling on social anxiety, assertiveness and self-confidence in nursing students and the relationship of these variables to change over time.

This is a randomized controlled and single-center study. The universe of the research consisted of nursing students who applied for counseling within the scope of the announcement made on the department web page. The research will be carried out in a state university, Faculty of Health Sciences, Department of Nursing between February 22, 2022 - December 23, 2022. In the study, the assignment of students to the intervention and control groups was made by simple randomization. Participant Information Form, Liebowitz Social Anxiety Scale, Self-Confidence Scale and Assertiveness Inventory will be used to collect the data of the study. Data collection tools will be applied three times simultaneously with the control group as a pre-test at the beginning of the study, as a post-test at the last session of the intervention group ( 2 month), and as a follow-up test 6 months after the last session of the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Liebowitz social anxiety scale score \>50
* 18 years of age or older
* Volunteering to participate in the study

Exclusion Criteria:

* Diagnosed with a mental disorders
* History of participating in a counseling program
* Currently receiving individual or group counseling
* Unable to attend more than two sessions
* Diagnosed with a physical or mental disorder during group sessions
Cognitive Reserve-building Activities in Multiple Sclerosis

The study is a crossover randomized controlled trial investigating the effect of increasing engagement in cognitive leisure activities for individuals with multiple sclerosis.

The study is a crossover randomized controlled trial investigating the impact of cognitive leisure activities on the cognitive functioning of individuals with multiple sclerosis (MS). The goal is to investigate whether increasing leisure activities may help prevent cognitive impairment in individuals with MS.

The trial consists of two studies. The first is a randomized controlled trial examining the effects of increasing engagement in cognitive leisure activities. The second is a qualitative interview-based study to identify factors that may improve adherence and acceptance of the intervention. The study employs a randomized, controlled crossover design, with 60 participants (30 with relapsing-remitting MS, 30 with progressive MS) assigned to either an intervention group or a passive control group for 12 weeks. After the initial 12 weeks the groups are crossed over and followed up after an additional 12 weeks. The intervention group will receive instruction and support to engage in cognitive leisure activities, while the control group will continue with their usual daily activities.

For a detailed description of the project, the full protocol can be found at:

https://dmsc.dk/onewebmedia/CRAMS%20research%20protocol.pdf

Eligibility Criteria:
Inclusion Criteria:

* RRMS, SPMS or PPMS
* Age 18-65
* EDSS score ≤ 6.5
* SDMT (or PASAT) score below -1 SD
* No depression based on the MDI
* Able to use computer or smartphone and has internet access
* If in treatment with one or more of the following medications, the dosage must be stable:

  * Cannabinoids
  * Anticholinergic medications
  * Sedatives e.g., benzodiazepines
  * Opioids
  * Antispasmodics
  * Beta-blockers
  * Antidepressant medication
  * Fampridine

Exclusion Criteria:

* Planned start-up or discontinuation of one or more of the above-mentioned medications
* Structural brain changes following previous head trauma or neurological conditions other than which lead to structural changes or affect cognitive abilities
* Epilepsy
* Significant psychiatric co-morbidity
* Significant somatic co-morbidity including, but not limited to, severe cardiovascular disease as well as liver, kidney, and endocrine diseases
* Relapse 3 months prior to inclusion
Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

The purpose of this double-blind study is to evaluate the safety, reactogenicity and immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30 years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
* Healthy permanent residence 2-30 years old.
* Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months.
* Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
* Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial.
* Receipt of blood or blood-derived products in the 3 months preceding vaccination.
* Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
* Receipt of any live virus vaccine in the 15 days preceding vaccination.
* Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
* Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
* Thrombocytopenia.
* History of thyroid gland excision or treatment for thyroid gland disease in last 12 months.
* Functional or anatomic asplenia.
* History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
* Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome).
* Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.
* In pregnancy or lactation or pregnant women during the test plan
* Any condition that, in the judgment of investigator, may affect trial assessment.
The Significance of Vitamin D Storage in Adipose Tissue

The study will examine the role of adipose tissue in vitamin D physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled.

vitamin d versus placebo will be given for 12 months. Biopsies will be taken at baseline and every 6 month for 2 years. Blood samples will be collected every 6th month. the study will thus give information on storage during vitamin d supplementation as well as use of vitamin d fat stores after stopping vitamin D supplementation

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* hypercalcemia
* pregnancy
* women without safe contraception
Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity

The purpose of this study is to determine whether Zydena (Udenafil) has effect on cerebral blood flow and peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.

Udenafil is a newly developed selective phosphodiesterase type 5 inhibitor (PDE5i). Since PDE5i is known to relax smooth muscle cells, it is suggested that PDE5i may dilate cerebral vessels and lead to an increase in cerebral blood flow. The main mechanism of subcortical vascular cognitive impairment are hypoperfusion of the brain. Therefore, in this study, the investigators will investigate whether Udenafil can increase cerebral blood flow and also lower peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.

Eligibility Criteria:
Inclusion Criteria:

for Normal control group

* Normal cognition by detailed neuropsychological tests
* Brain MRI scan with no or minimal white matter hyperintensities

for Subcortical vascular mild cognitive impairment (svMCI)

* Clinical diagnosis of svMCI
* Brain MRI scan with severe white matter hyperintensities

Exclusion Criteria:

- Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)
3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. The first type of expander is made by hand in an orthodontic laboratory, and the second type of expander is designed on a computer and printed using 3D printers. Both expanders are already used in the MUSC Orthodontics Clinic. The purpose of this study is to see if the 3D printed expander is as effective as the traditional expander made by hand in the laboratory, with more comfort to the patient. Patients participating in the study will be randomly assigned to one of two groups: group A will be treated with a laboratory-made maxillary expander, and group B with a 3D-Printed maxillary expander. Information will be collected on the participants' standard clinical follow-up visits including photos, x-rays, and dental photo scans over the course of 6 months to see how the expander is working. In addition, as part of the research study, the participant will be asked to complete online questionnaires with assistance from parents or guardians about his/her quality of life and perception of possible pain and discomfort at different time points. The potential benefits of this study include the use of 3D technology to improve the quality of the orthodontic treatment, with more comfort to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Maxillary anterior and/or posterior transverse deficiency with or without crossbite
* Age of 8-13 years
* Children whose parents/guardians are willing to consent to the child participating in the study
* Children ages 12-13 who are willing to assent to participating in the study
* Children who are orthodontic patients at the Medical University of South Carolina Department of Orthodontics
* Subjects and parents/guardians who have access to an electronic device with internet connection

Exclusion Criteria:

* Patients with previous or ongoing orthodontic treatment
* Patients whose parents have a strong preference as to which expander is used
* Patients with a history of temporomandibular disorders
* Presence of congenitally missing teeth
* Traumatic loss of maxillary incisors
* Patients with craniofacial syndromes, or cleft lip and/or palate
Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year

The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication

Wassel IV thumb duplication is a congenital hand anomaly characterized by the presence of two adjacent thumbs. This condition has significant functional and aesthetic implications.

Previous studies have highlighted the complexity of the surgical management of Wassel IV thumb duplication, underscoring the need for an individualized approach for each case. Early interventions are often recommended to optimize long-term functional and aesthetic outcomes.

The field of study for evaluating these outcomes focuses on the analysis of the medium and long-term consequences of surgical interventions in children with this malformation. Evaluation criteria may include hand functionality, thumb mobility, overall aesthetics, and other aspects relevant to the quality of life of the affected pediatric patients. This medium and long-term approach offers crucial insights for refining treatment protocols and improving the overall management of this condition.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Wassel IV thumb duplication
* Pediatric patients aged between 1 and 18 years
* Minimum of one year post-operative follow-up
* Availability of radiographic, photographic, and medical data
* Regular post-operative medical follow-up with the referring surgeon
* Legal guardian and patient consent (non-opposition) to participate in the study

Exclusion Criteria:

* Subjects under guardianship or deprived of liberty
* Opposition from legal guardians or from the patient to participate in the study
High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy

To investigate the Effect of High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy Patients.

Forty two patients with Cervical Radiculopathy will participate in this study. The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to High Tone Power Therapy, three times per week for four weeks. The evaluation methods are cervical joint position error test, neck disability index, Cervical range of motion (CROM) and visual analogue scale

Eligibility Criteria:
Inclusion Criteria:

* Their ages range from 35 to 50 years.
* Both sex
* With mild to moderate cervical disability according to the neck disability index
* Unilateral cervical radiculopathy for more than 6 months.
* Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
* Normal body mass index (18.5 - 24.99Kg/m2).

Exclusion Criteria:

* Any other musculoskeletal disorders of the spine or upper extremity
* Patients with any other Neurological deficits, psychiatric disease Cervical myelopathy, Cognitive problems, vertebral fractures and previous history of spine or cervical surgery.
* Neck pain with vertigo or with bilateral upper limbs referred pain.
* Clinical instability, recent trauma and vertebrobasilar insufficiency.
* Structural abnormalities of the spine, osteoporosis, and spasmodic torticollis.
* Inflammatory or other specific disorders of spina such as ankylosing spondylitis and rheumatoid arthritis
Whole Body Vibration Training Among Older People Using Sheltered Housing

The purpose of this randomised (double-blind) controlled exercise intervention trial is to determine whether the whole body vibration (WBV) training can effectively improve physical functioning of older people living in or regularly using services of sheltered housing, reduce their fear of falling, and prevent falling. The study comprises a 10-week training period and a 10-month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* lives in sheltered housing or uses regularly services provided by sheltered housing
* ambulatory, able to walk independently with or without a walking aid
* Mini Mental State Examination (MSSE) points 16 or more

Exclusion Criteria:

* knee or hip prosthesis
* osteosynthetic material in lower limbs
* stiffening operation of the spinal column
* cardiac pacemaker
* recent fracture (\< 1 yr for lower limb or spinal fractures, \< ½ yr for upper limb fractures)
* recent major surgical operation
* acute thrombosis or its high risk
* acute musculoskeletal inflammation
* gall or bladder stones
* problematic hernia
* unstable cardiovascular or other systematic disease
* tumor
* diabetic neuropathy
* strong vertigo
Etomidate vs. Midazolam for Sedation During ERCP

Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.

The investigators are now trying to investigate that etomidate with meperidine combination regimen is superior to the midazolam with meperidine more effective and less harm on sedation during the ERCP procedure.

ERCP (Endoscopic retrograde cholangiopancreatogram) is an uncomfortable and time-consuming procedure compared to other endoscopic procedures. Most ERCP procedure had been performed in sedation using tranquilizers and pain-killers.

Until recently, midazolam and opioid combination regimen recognized as a standard therapy is widely used, but the sedative effect is insufficient and intermittent paradoxical reaction has been questioned. Another drug, such as propofol, has been known that the sedative effect is superior one of the midazolam but disappointed due to narrow therapeutic range of respiratory distress and absence of antagonist. Meanwhile, recently up-coming drug, etomidate which is a modulator of GABA-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.

For these advantages, this short acting sedative drug has been widely used in the emergency room during minor operation and in the operation room for induction. However, research on the efficacy during ERCP was not yet published.

In this regards, the purpose of the investigators study is to prove the efficacy of etomidate for sedation and to establish new evidence based sedation guidelines during ERCP procedure.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are scheduled diagnositic or therapeutic ERCP.
* Age : more than 20 and less than 90 years old
* ASA(American Society of Anesthesiologists) classificiation : I, II, III

Exclusion Criteria:Patients following

* Refuse to be enrolled
* ASA American Society of Anesthesiologists)classification IV, V
* Breast feeder
* The mentally ill
* Drug abuser
* Hypersensitivity to sedative or opioids
* Alcohol intoxication or dependency
* Body mass index (BMI) 36kg/m2 or more
* Unstable vital sign

  1. tachypnea, respiration rate more than 25/min or less than 10/min
  2. Oxygen saturation : 90% or less
  3. Systolic blood pressure : less than 90 mmHg or more than 180 mmHg
  4. Diastolic blood pressure : less than 50 mmHg or more than 100 mmHg
  5. Heart rate : more than 120 beat/min or less than 50 beat/min.
TruGraf® Testing in High-Risk Kidney Transplant Recipients

This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* High immune risk kidney transplant recipients defined by one of the following criteria: either a positive pretransplant donor specific anti-human leukocyte antigen (HLA) antibody, or a pre-transplant panel reactive antibody \>75%.
* Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
* Stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels).
* Kidney transplant patients who are at least 30 days post-transplant.

Exclusion Criteria:

* Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
* Recipients who do not meet criteria of high-immune risk.
* Recipients of previous non-renal solid organ and/or islet cell transplantation.
* Infection with HIV.
* Infection with BK.
* Patients that have nephrotic proteinuria (urine protein \>3 gm/day).
Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test

Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy are declining, and an alternative strategy is needed urgently. The investigators sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a region with high rates of multiple drug resistance.


Eligibility Criteria:
Inclusion Criteria:

1. positive results of rapid urease test

Exclusion Criteria:

1. liver cirrhosis,
2. chronic kidney disease,
3. bleeding tendency,
4. pregnant,
5. allergy to antibiotics
How to Prevent Heart Failure Readmission by Using Lung Impedance Device (HOPE-HF Study)

The readmission of Heart Failure (HF) patients for exacerbation HF within 30-day is unmet goal. The mail reason for readmission is excessive accumulation of fluid in patient's lung. According our data (1,2) around 40% of HF patient have excessive lung fluid at discharge from HF hospitalization ("unacceptable" residual congestion on discharge). In other words, around 40% patients are discharged from HF hospitalization prematurely when they are not ready to be discharged. Only 60% of HF patients are discharged from HF admission with "acceptable" level of residual pulmonary congestion (2). There are some techniques to assess "readiness" of HF patients for discharge. Pulmonary congestion (lung fluid accumulation) may be assessed non-invasively by measurement Brain Natriuretic Peptide (BNP), (3,4), by lung ultrasound (LUS), (5-7) and by Lung Impedance (LI) method (1,2). LUS is operator depended technique. LI and BNP techniques are most reliable methods (2) and easy to use.


Eligibility Criteria:
Inclusion Criteria:

* Acute Heart Failure Patients Prior to Hospital Discharge

Exclusion Criteria:

* No Cardiac Resynchronization Device Implanted During Current Hospitalization
* Estimated glomerular filtrating rate (GFR) less than 30 ml/min
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
* Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study treatment as specified in the protocol.
* Men who are not surgically sterile must agree to remain abstinent or use a condom, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.

Exclusion Criteria:

* Active brain metastases.
* Malabsorption or other condition that interferes with enteral absorption.
* Clinically significant cardiovascular dysfunction or liver disease.