cyrilzakka/clinical-trials huggingface dataset:
The Effect of Video-assisted Mobilisation Training on Mobility, Anxiety and Pain After Coronary Artery Bypass Surgery

This study is a Randomized Controlled trial.The aim of this study was to investigate the effect of preoperative routine patient education and video-assisted mobilization training on postoperative mobility, anxiety level and pain in patients undergoing coronary artery bypass graft surgery.

Hypotheses of the study:

H1= Routine patient education and video-assisted mobilization training have an effect on postoperative anxiety level in patients undergoing coronary artery bypass graft surgery.

H2= Routine patient education and video-assisted mobilization training have an effect on postoperative mobility in patients undergoing coronary artery bypass graft surgery.

H3= Routine patient education and video-assisted mobilization training have an effect on postoperative pain in patients undergoing coronary artery bypass graft surgery.

This study is a Randomized Controlled trial. The study consists of 80 patients, 40 control and 40 study group. Patients in the experimental group who underwent coronary artery bypass graft surgery completed the "State Trait Anxiety Scale" in the preoperative period.

Then, video-assisted mobilization training was given together with routine patient training.After the patient underwent surgery, the "State Trait Anxiety Scale" was completed again before the first mobilization.After the first mobilization, "Patient Mobility Scale" and "Observer Mobility Scale" were completed."State Trait Anxiety Scale" was used again on the 2nd postoperative day before mobilization."Patient Mobility Scale" and "Observer Mobility Scale" were used after the patient was mobilized.

Patients in the control group who underwent coronary artery bypass graft surgery completed the "State Trait Anxiety Scale" in the preoperative period.Routine patient education was then given.After the patient underwent surgery, the "State Trait Anxiety Scale" was completed again before the first mobilization.After the first mobilization, "Patient Mobility Scale" and "Observer Mobility Scale" were completed. The "State Trait Anxiety Scale" was used again before mobilization on the 2nd postoperative day.After the patient was mobilized, "Patient Mobility Scale" and "Observer Mobility Scale" were used.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary artery bypass graft surgery,
* Patients aged 18 years and older,
* Patients who can speak Turkish,
* Patients without a diagnosis of cognitive and psychiatric disorders that prevent them from expressing themselves,
* Patients open to communication,
* Patients who volunteered to participate in the study and gave verbal and written informed consent.

Exclusion Criteria:

-
Relationship of Essential Hypertension and Its Treatments on the Postoperative Pain Management: a Prospective, Observational, Cross-sectional Study

Numbers of postoperative PCA related side effects among three groups will be determined by comparing and analyzing frequency distributions. To determine whether the patients with hypertension require less post operative opiate analgesics than others, multivariate analysis with repeated measures will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. The major aim of the study is to test the hypothesis that the morphine comsumpted by the hypertension group is less than those of the normotension group. The minor aims for the study are the difference related to pain intensity, or the incidence of side effects among groups.


Eligibility Criteria:
Inclusion Criteria:

* 300 eligible subjects
* No contraindication for inhalation anesthesia
* Elective surgery
* Age between 20-75 y/o
* No contraindication for postoperative morphine pain control
* Female or male
* Essential hypertension stage I and II (140\<=SBP\<=180; 90\<=DBP\<=110)

Exclusion Criteria:

* Liver disease
* Renal disease
* Those who is presumed to go to ICU after surgery
* The patients with dementia or conscious disturbance
* Pregnancy or breast feeding
* Secondary hypertension
* events in recent 6 months myocardial infarction cardiac bypass surgery unstable angina cerebrovascular events congestive heart failure significant arrhythmia thoracic surgery
Effect of Prednisolone Treatment on Uterine Natural Killer Cells

This study aims to investigate the role of uNK cells and the association with prednisolone.

Glucocorticoids prednisolone is considered as a potential therapy in women with recurrent miscarriage. However, the evidence for treatment with prednisolone is still inconclusive and the relevant mechanism merits further investigations.

The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Women with a history of 3 or more consecutive miscarriages
2. Women younger than 40 years old

Exclusion Criteria:

1. Allergy to prednisolone
2. Women who have any uterine anomaly
3. Antiphospholipid syndrome
4. Hydrosalpinx
5. Thrombophilia
6. Abnormal thyroid function tests
7. women with diabetes,
National Early Warning Score and D-dimer to Identify Medical Patients At Low Risk of 30-day Mortality

The aim is to determine if the National Early Warning Score combined with plasma D-dimer levels can be used in risk stratification of acutely ill medical patients presenting to a Danish Emergency Department. The investigators wish to identify patients at low risk of mortality within 30 days.

Large increases in emergency admissions are raising concerns about whether all admissions are necessary. If there was a fast and reliable system that could be used to determine the risk of all medical patients, many low-risk patients could be safely returned to primary care or outpatient follow-up clinics.

The investigators wish to determine, if the combination of the National Early Warning Score and plasma D-dimer levels can be used to identify patients at low risk of mortality within 30 days in an unselected group of medical patients presenting to a Danish Emergency Department.

This is a prospective observational study that will be performed on adult medical patients referred to the Emergency Department of a Danish hospital to be assessed for possible admission. The study will be performed in the Emergency Department of Hospital of South West Jutland in the region of Southern Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the Emergency Department of Hospital of South West Jutland
* Requirement of any blood test
* Age 18 years
* Informed consent given

Exclusion Criteria:

* Age 18 years
* Informed consent not given
Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease

Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (CAD). Most of the attention in treating CAD in type 2 diabetes is understandably directed toward treating coronary artery conditions. However there are other treatable culprits in these patients.

Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. Regression of LVH has been associated with an improved prognosis, independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with CAD might will be reduced if the investigators can find novel therapies to regress LVH.

Alpha-lipoic acid reduces oxidative stress which then regresses LVH. Alpha-lipoic acid can improve endothelial function in diabetic conditions. Hence, the main aim of this study was to assess whether alpha-lipoic acid could regress LVM in type 2 diabetic patients with CAD.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* CAD
* Left ventricular hypertrophy
* HbA1c below 7.0%
* blood pressure \<130/80 mmHg

Exclusion Criteria:

* Patients were excluded if they were currently alpha-lipoic acid for one year, had a previous adverse reaction to alpha-lipoic acid.
* hey were also excluded if they had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent.
* Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.
Upper Extremity Rehabilitation Using Game Rehabilitation System With Functional Electrical Stimulation for Stroke Patients

The purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

* first-ever ischemic or hemorrhagic stroke
* wrist extensor of medical research council scale 1\~3
* No clinical evidence of limited passive range of motion of affected wrist

Exclusion Criteria:

* age \<18 years
* severe aphasia resulting in communication difficulties confounding intervention and outcome measures
* severe cognitive impairment resulting cooperation difficulties
* spasticity \> modified Ashworth scale 1+
Temperature and Humidity Among Different Anesthesia Work-station

The effects of preserving humidity and temperature by low flow anesthesia are different in each other anesthesia workstation.

The fresh gas flow(FGF) is dry and cold in old fashioned anesthesia machine, especially at high folw (above 1 L/min). To the contrary, it has been assumed that the heat and humidity of FGF may be preserved using low FGF (below 1 L/min) during anesthesia or new anesthesia work station. However, it has not been proved yet. We hypothesized that the heat and moisture of FGF may be different in various FGF rate during anesthesia. In addition, it may be different in accordance to anesthesia work station. Therefore, we planed prospective observational study that will demonstrate that the difference of heat and moisture of FGF in different anesthesia work station (Excel; 1st generation anesthesia machine of Datex-Ohmeda Corp., Avance; 2nd generation anesthesia work station of Datex-Ohmeda Corp., Cato; 2nd generation generation anesthesia work station of Drager, Primus; 3rd generation generation anesthesia work station of Drager) and different FGF (0.5, 1, 4 L/min)

Eligibility Criteria:
Inclusion Criteria:

* patients who planned more than 2 hour operation under general anesthesia
* ASA class 1,2
* blood loss less than 500ml

Exclusion Criteria:

* acute/chronic cardiac or respiratory disease
A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy

The aim of this study is to observe the consumption effect of early lollipop sucking in preschool children after adenotonsillectomy through clinical experiments, and to explore the impact of early postoperative lollipop consumption on postoperative agitation, incidence of postoperative nausea and vomiting, and postoperative wound recovery rate.

Participants will be randomly allocated to two groups:a lollipop sucking group (Group A) and a control group (Group B), Two groups of children were sent to the recovery room (PACU) for observation after extubation . Group A patients were given lollipops for sucking after waking up, while Group B received routine nursing treatment.

The goal of this clinical trial is to explore whether lollipops have advantages in early postoperative feeding and alleviating postoperative agitation in children, and to provide reliable clinical evidence for the consumption of lollipops after surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients who choose to have adenotonsillectomy surgery
* the American Society of Anesthesiologists (ASA) physical status ranked I-II
* competent to provide informed consent

Exclusion Criteria:

* psychiatric disorders
* upper respiratory tract infection
* high risk of reflux aspiration
* carbohydrate malabsorption syndrome and other endocrine or genetic metabolic diseases (contraindications of lollipop ingredients)
Studying Genes in Samples From Younger Patients With Rhabdomyosarcoma

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies genes in samples from younger patients with rhabdomyosarcoma.

OBJECTIVES:

* To obtain a larger cohort of rhabdomyosarcoma samples (alveolar and embryonal) to establish a more accurate estimate of the frequency of particular genetic lesions.
* To provide the statistical power to establish an unambiguous connection between focal genetic lesions, histological subtype, and outcome for patients with rhabdomyosarcoma.

OUTLINE: DNA samples are analyzed in solid and liquid phase for exons of all genes mutated from previous discovery. DNA is then eluted and sequenced by illumina platform.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Matched genomic deoxyribonucleic acid (DNA) from tumor and germline samples from patients diagnosed with rhabdomyosarcoma (alveolar or embryonal)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age

This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Japanese subjects 18 to 49 years of age, defined as Japanese born in Japan, with both parents and 4 grandparents who wer born in Japan (family tree by history), and who have not lived outside of Japan for more than 5 years total (confirmed by passport or interview)

Exclusion Criteria:

* Participation in other studies involving investigational drug(s), investigational vaccines, or investigational medical devised within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
Meeting an Unmet Need in Multiple Sclerosis

The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g., improved well-being, QOL, coping, etc.) that may occur in tandem.

The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g., improved well-being, QOL, coping, etc.) that may occur in tandem.

To achieve this, the investigation has the following specific aims:

Specific Aim 1: Conduct a pilot Randomized Controlled Trial (RCT) of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in reducing depression and anxiety.

Hypothesis 1: Individuals who participate in the Unified Protocol intervention will report a decrease in their depression and anxiety compared to individuals in the control group.

Specific Aim 2: Conduct a pilot RCT of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in improving secondary outcomes of psychological well-being, QOL, coping, and MS symptomatology over time.

Hypothesis 2: Individuals who participate in the Unified Protocol intervention will report an increase in psychological well-being, QOL, coping, and MS symptomatology over time compared to participants in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis
* 18 years of age or older
* Experiencing significant depression and/or anxiety
* English-speaking
* Able to provide informed consent
* Access to the internet

Exclusion Criteria:

* History of any other neurological illness (e.g. traumatic brain injury, epilepsy, dementia)
* Current participation in another randomized controlled trial
* Cognitive impairment that would affect my ability to fully participate in the group
* Unable to attend group sessions
* Active participation in another formal clinical group or psychological therapy
* Any other medical or psychological condition that, in the judgement of the investigators, prevents successful participation in the study
Natural History Study of Batten Disease

This is a multicenter, international, study to assess the natural history data from people with Batten disease by collecting both retrospective and prospective information about the motor, behavioral and functional capabilities of patients. The study initially has 2 cohorts. Cohort 1 (n ≈ 75) includes subjects with CLN6 Batten disease. Cohort 2 (n ≈ 120) includes subjects with juvenile CLN3 Batten disease. Additional cohorts for other Batten disease subtypes may be added in the future.


Eligibility Criteria:
Inclusion Criteria:

* Subject has or had a diagnosis of CLN6 or CLN3 Batten disease that has been confirmed by genotyping (documented presence of a variant on both gene alleles). Confirmation of genotyping will be performed prior to enrollment.
* Subject (or legally authorized representative) has provided written informed consent (or assent) and authorization for use and disclosure of personal health information or research related health information
* Subjects may enroll starting from birth

Exclusion Criteria:

* Subject has or had experienced another illness that is known to cause cognitive decline (eg, trauma, meningitis, hemorrhage)
* Subject received or receives an investigational gene therapy
Clinical and Radiographic Outcomes of Distal Metatarsal Metaphyseal Osteotomy for Central Primary Metatarsalgia

The primary propose of this prospective study is to specifically evaluate the safety and effectiveness of Minimally Invasive Distal Metatarsal Metaphyseal Osteotomy (DMMO) in treating patients with persistent central primary metatarsalgia, associated or not to hallux valgus and lesser toe deformities, identifying possible contraindications in relation to some demographic parameters (age, gender, BMI, and smoking). The second objective is to verify the potential of DMMO in restoring a harmonious foot morphotype according to Maestro's criteria and if these radiographic parameters are correlated with clinical outcomes, maintaining the predictive value of these criteria during preoperative planning also for this percutaneous surgery.

A consecutive series of patients with metatarsalgia is consecutively enrolled and treated by DMMO. According to Maestro criteria, pre-operative planning is carried out by both clinical and radiological assessment. Patient demographic data, AOFAS scores, 17-Foot Functional Index, Manchester-Oxford Foot Questionnaire, SF-36, VAS, and complications are recorded. Maestro parameters, relative morphotypes, and bone callus formation are assessed. Statistical analysis is carried out (p \< 0.05).

Eligibility Criteria:
Inclusion Criteria:

* forefoot persistent pain;
* presence or not of forefoot plantar hyperkeratosis lesions;
* ineffective conservative and orthotic treatment performed for at least 6 months.

Exclusion Criteria:

* arthritis and stiffness of MTP joint;
* congenital deformities of the foot;
* hallux rigidus;
* Freiberg infraction;
* Morton's neuroma;
* diagnosis of rheumatic, metabolic, neurologic, infective, or psychiatric pathologies;
* previous trauma;
* foot and ankle surgery,
* any form of secondary or iatrogenic metatarsalgia.
Seprafilm® Adhesion Barrier and Cesarean Delivery

A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time).

Patients presenting to labor and delivery for delivery will be screened for eligibility. If a patient meets the inclusion and exclusion criteria, she will be offered enrollment in the study. After the project and informed consent are reviewed with the patient and all questions are answered, she will be asked to sign the informed consent. At this point, she will be considered a candidate for randomization.

If the patient subsequently undergoes a cesarean delivery, she will be randomized to either:

1. Group A - Placement of Seprafilm® prior to abdominal closure
2. Group B - Routine closure without placement of Seprafilm® The chances of being assigned to either group will be equal (i.e., 1:1 randomization). The patient will be blinded with regard to Seprafilm placement.

The investigators will collect additional data about the patient, her antepartum course, intra-operative events, and post-operative course. There are no additional tests or procedures ordered or performed during the hospital stay as part of this protocol. Enrollment in this study is not expected to alter the patient's length of stay.

The antepartum, operative, and post-operative care of the patient will as directed by the patient's physician and participating institutions's standard policies and procedures. This study in no way changes or directs the care the patient would receive, except with regard to the placement of Seprafilm® Adhesion Barrier.

A short-term telephone follow-up will be conducted approximately 6-8 weeks following randomization to assess for immediate post-operative complications.

If a patient becomes pregnant again and undergoes a repeat cesarean delivery at a participating institution, the location and severity of adhesions (if any) would be assessed at the time of repeat cesarean delivery. The investigators will extract additional data from the chart including operative times, blood loss, and complications. An evaluation of adhesions would conclude the patient's participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are planning or have the potential to undergo cesarean delivery
* Age over 18
* Able to consent to study

Exclusion Criteria:

* Planned tubal ligation
* Known allergy to hyaluronic acid
* Medical or other serious condition which will interfere with compliance and/or ability to complete study protocol