cyrilzakka/clinical-trials huggingface dataset:
Pain, Exercise and Psychological Well-being in Pectus Excavatum

Recovery following major surgical procedures can be influenced by both physical (optimization of cardiopulmonary function, pain control, activity) and psychological factors. Physical activity recommendations for post-operative patients is difficult, in part because little is known about the short- and long-term benefits of exercise and mobility on post-operative pain and return to normal functioning.

Major surgery has a drastic impact on the lives of patients and their families. Often, patients undergoing the Nuss procedure have lingering pain which can complicate recovery. Depending on the nature of the surgery and the severity of disease, this recovery period can be as short as a few days, or it can take several weeks and even months. Few studies have demonstrated the benefit of physical activity and exercise postoperatively on returning to normal function. Additionally, research has suggested that pain and recovery can be influenced by psychological factors.

The investigators will use wireless activity monitors to assess the activity levels of children who undergo major musculoskeletal surgery, specifically the Nuss procedure. The investigators will also evaluate this population for psychological well-being. In this pilot study, the investigators identify goals and objectives which will provide preliminary evidence for physical and psychological recommendations to reduce post-operative pain and improve recovery.

Families will be asked to complete questionnaires at different phases in the surgery (pre-surgery, post bar insertion, post bar removal). Children will be instructed to record any pain they are experiencing as a result of their condition or the surgery at various time points. The activity levels will also be followed over the course of the recovery period.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 12-18 years that are scheduled to undergo a surgical procedure for the correction of pectus excavatum

Exclusion Criteria:

* History of chronic pain disorders
* History of major mental illness such as psychosis or bipolar disorder
* Cognitive impairment significantly below average age and/or grade level
* Non-English speaking parent or child
* Unable to obtain and keep access to a cellular phone
* Loss of wireless electronic activity monitor and refusal to replace to remain in the study
Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement

The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25% bupivacaine for controlling pain after total knee replacement to improve the quality of post-operative care.

Compare post operative pain control after total knee replacement by periarticular injection with 0.25% bupivacaine compare with 0.9% normal saline.

Eligibility Criteria:
Inclusion Criteria:

* primary osteoarthritis patients undergoing total knee replacement at Siriraj Hospital
* BMI between 20-35
* having a full understanding of the question in this trial

Exclusion Criteria:

* allergy to NSAIDs, Acetaminophen, Bupivacaine
* blood creatinine more than 1.5 mg/dl or creatinine clearance less than 60 mL/min
* abnormal liver function
* previous surgery on the knee undergoing total knee replacement
* patient could not receive spinal anesthesia
A Study to Determine if Mesh Placement During Bladder Surgery Can Reduce the Chances of Developing a Hernia

The purpose of this study is to compare any good and bad effects of using Ultrapro mesh along with the usual bladder removal surgery, versus having the usual bladder removal surgery without the use of the mesh.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing RC and IC formation in an elective setting,for cancer.

Exclusion Criteria:

* Expected survival \< 12 months
* Salvage RC
* Distant metastatic disease
Ciropractic Care and Pregnant Women

Objective: The aim of this study is to investigate the effectiveness of Chiropractic care on pain, quality of life and sleep in pregnant women compared to a control group.

The study is designed as non-randomized controlled trial. Forty-two pregnant women at least on the 14th week of gestation will be included. Control group will include women receiving regular care, but no chiropractic care. Care will extend for 4 weeks.

Outcomes measures include sleep quality, pain and quality of life questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women over the age of 18
* of at least 14 weeks gestation,
* with a good understanding of English, Spanish or French.

Exclusion Criteria:

* women over the age of 45,
* pregnancies of more than 35 weeks gestation
* high-risk pregnancies (tobacco, alcohol or substance use, diagnosed medical conditions or high blood pressure).
An Evaluation of an Adapted STEPPS Group Within Forensic Services

The purpose of this study is to determine how effective the STEPPS-HI group is at improving emotional regulation skills in those with identified difficulties in this area within forensic inpatient services. In addition, to explore whether there is increased acceptability of the adapted STEPPS group (STEPPS-HI) for this client group.

Systems Training for Emotional Predictability and Problem Solving (STEPPS) is a manualised group programme for people primarily with a diagnosis of Borderline Personality Disorder (BPD). Although, STEPPS groups have been run within prisons in USA, it has been less formally evaluated within forensic psychiatric settings except for Pipon-Young \& Cole (2012). Taking the learning from these studies into account, significant adaptations to the current STEPPS manual are needed to increase the acceptability and applicability of the group within forensic settings.

Following the adaption of the STEPPS manual for a forensic inpatient population (STEPPS HI), this research aims to investigate how effective the group is at improving emotional regulation skills in those with identified difficulties in the area as well as whether there is increased acceptability of the adapted group for the participants. The outcome of the research is intended to provide feedback on the adaption of the STEPPS manual and also an evaluation of the revised programme.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* To give informed consent to participate in the study.
* Currently a resident in a low or medium secure unit.
* Has been diagnosed as meeting DSM-IV criteria for a personality disorder at some stage in their mental health history.
* Has identified difficulties with emotional regulation.
* Be willing and have suitable abilities to participate in a group.
* To be assessed by the clinical team as sufficiently psychologically robust to participate in the group and the research.

Exclusion Criteria:

* Psychiatric/psychological or any other difficulties that would mean that participants could not give informed consent.
* Intellectual/cognitive impairment which prohibits participants ability to consent or fully comprehend the study or study materials.
* Non-English speakers as there is no provision for interpreters.
* Unable to manage a group environment due to risk to self and others including bullying and violence (this will be assessed by the clinical and STEPPS-HI facilitation team.
* No evidence of emotional regulation difficulties.
A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults

This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy participants
* Positive test for influenza A infection
* No more than 72 hours elapsed between onset of influenza-like illness and start of study drug
* Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chills, fatigue, anorexia, or nausea PLUS one moderate or severe respiratory symptom such as cough, sore throat, or rhinorrhea
* For women of childbearing potential: negative pregnancy test and agreement to use acceptable contraceptive methods for at least 120 days after study drug administration
* For men: agreement to use acceptable contraceptive methods for at least 30 days after study drug administration

Exclusion Criteria:

* Creatinine clearance less than or equal to (\</=) 80 milliliters per minute (mL/min)
* Any significant medical conditions or laboratory abnormalities
* Clinical signs and symptoms consistent with otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection
* Use of antiviral therapy in the period from onset of influenza-like illness and prior to enrollment
* Pregnancy at Screening or is currently pregnant or breastfeeding
* Investigational therapy within 30 days or 5 half-lives prior to start of study drug, whichever is greater
* Prior anti-influenza monoclonal antibody use
* Receipt of a nasal influenza A vaccine within 14 days prior to Screening
* Positive test for influenza B or influenza A+B within 2 weeks prior to study drug
* History of significant tobacco use or drug/alcohol abuse
* Chronic use of oral or inhaled corticosteroids within 30 days prior to Screening
* Autoimmune disease, known immunodeficiency of any cause, or use of immunosuppressive medications
* History of any chronic respiratory condition
* Human immunodeficiency virus (HIV) with cluster of differentiation (CD) 4 count \</= 200 cells per milliliter (cells/mL) in the past 12 months
* Serious infection requiring oral or IV antibiotics within 14 days prior to Screening
Drugs Experience for Adolescents With Anorexia

The purpose of this study is to access to the experiences of adolescents, their parents and healthcare professionals regarding psychotropic drugs in anorexia nervosa.

No preconceived ideas (according to qualitative methods) but a question: what are the participants' perceptions and experiences of psychotropic drugs in anorexia nervosa? In an adolescent medicine department.

Psychotropic prescription is common to adolescents suffering from anorexia nervosa. A first qualitative study (E3A Protocol "Experience of adolescents with anorexia nervosa toward antidepressants") looked at the experience of antidepressants among 15 adolescents suffering from anorexia nervosa. Analysis of the interviews identified two meta-themes:

1. Reactions to the proposal of antidepressant with an opposition phase (about the existence of depressive symptoms and about negative preconceptions) and need to share with family and other teenagers.
2. Reactions to antidepressant use with ambivalence and an initial perception of coercion, and effects of antidepressants (psychological effects, effects on the body and on anorexia nervosa and effects perceived through the eyes of others).

Nine adolescents (out of 15) were also taking an atypical antipsychotic (APA) often prescribed in case of anorexia nervosa resistance.

The need to share with family about the proposal of antidepressant and the effects perceived through the eyes of others (including parent's eyes) lead us to take an interest in parents perceptions.

Two decisive periods were identified: What do healthcare professionals think about psychotropic treatments for anorexia nervosa in adolescence? How do they propose treatment?

Interviewing teenagers, their parents as well as healthcare professionals, will enable to access to the complexity of representations and experiences of these psychotropic drugs in anorexia nervosa.

Eligibility Criteria:
Inclusion Criteria:

Adolescents :

* Aged 12 to 25 years
* Suffering from anorexia nervosa (restrictive or mixed) according to DSM-5 (Diagnostic and Statistical Manual) criteria
* Received psychotropic drugs (antidepressant treatment and/or APA) during their care, either ongoing or discontinued before this study started

Parents of adolescents suffering from anorexia nervosa for whom a psychotropic drug has been prescribed and whose adolescents meet inclusion criteria

Healthcare Professionals working with adolescents suffering from eating disorders

Exclusion Criteria:

Adolescents :

* Atypical eating disorder that does not meet the DSM-5 criteria for restrictive or mixed anorexia nervosa
* BMI\<15
* Prescription of an antidepressant other than an SSRI (Selective Serotonin Reuptake Inhibitor)
* Prescription of an APA for the indication of psychotic symptoms
Feasibility and Safety of the 360-degree Turn Test Delivered Via Telehealth

Walking, balance problems and falls are common in patients with multiple sclerosis. The 360-degree turn test is a test used to evaluate balance. Telerehabilitation is a rehabilitation system that has been increasingly used in recent years. Still, there is a need for studies on whether there is any difference between face-to-face evaluations with patients and telehealth methods. This study aims to investigate the feasibility and safety of the 360-degree turn test delivered via telehealth.

The 360-degree turn test will be performed in the participant's home environment using a standardized protocol from previously published literature. Exercise professionals will administer the test during a single videoconferencing exercise appointment. Prior to the study commencement, clinicians will be given a 30-minute education session and written protocol to facilitate the standardized and safe performance of the test.

The test will be performed in the participant's home environment using videoconferencing. The clinician will explain the 360-degree turn test. Clinicians will record the device used by the participant. Where possible, participants will be instructed to adjust their device or camera to improve clinician visibility. The test will be stopped immediately if the participant reports increased pain, a moderate-significant increase in breathlessness, or is unsteady.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of multiple sclerosis
* EDSS score ≤ 5.5

Exclusion Criteria:

* Not giving consent
* History of dislocation or surgery in the lower limbs
* History of fall within six months
* Any other disease, medication or intervention that can cause balance disturbance
* Patients who cannot use devices that is required for teleconference
* Patients that cannot understand English/ Turkish
Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)

Hepatitis B Virus Antibody Booster Program

The purpose of this study is to vaccinate plasmapheresis donors for collection of high titer plasma to be used in the manufacture of Hepatitis B Immune Globulin (HBIG).

Eligibility Criteria:
Inclusion Criteria

* Age 20-55 years.
* Naïve or previously hepatitis B-vaccinated males or females.
* Normal and healthy as determined by medical history, physical exam, vital signs and clinical laboratory tests
* Subject must meet all required/recommended subject suitability criteria that pertain to normal source plasma donors with the following exception:
* Subjects who previously tested positive for HBsAg may be accepted into the anti- HBs program provided they now test negative and meet all other normal donor suitability criteria.
* Written informed consent.

Exclusion Criteria:

* Subjects who have received a hepatitis B vaccination in the previous six months.
* History of hypersensitivity to yeast or any components of the Engerix-B® vaccine
* History of hypersensitivity to any hepatitis B-containing vaccine.
* Use of any investigational product within the past 30 days or during the course of the study.
* Use of steroids or immunosuppressives during the study period.
* Received immunosuppressive therapy (including systemic steroids) within 30 days before study entry
* Subjects who have received cytotoxic therapy (in the previous 5 years prior to study entry)
* Received parenteral immune globulin products or blood products within 3 months before study entry with the following exceptions:
* RhoGAM (or equivalent anti-D immune globulin) within 6 weeks before study entry;
* Pertussis immune globulin: no exclusion
* Received parenteral immune globulin products or blood products (within 3 months before study entry)
* Past, present, or suspected IV drug use
* Positive HIV, HBV\* or HCV test result (\*except as described above in Inclusion Criteria)
* Autoimmune disease (such as, but not limited to demyelinating disease)
* Subjects with cancer, heart disease (including hospitalization for myocardial infarction, arrhythmia, syncope, congestive heart failure), uncontrolled hypertension, uncontrolled insulin-dependent diabetes mellitus, seizures, kidney disease
* Severely or morbidly obese, or higher obesity classification, which corresponds to BMI of 35 or higher
* Pregnancy or lactation.
Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation

Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve replacement, it is still restricted to high surgical risk patient who are frail. The aim of the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and functional recovery after TAVR

Primary objective: identify geriatric biomarkers associated with vital/functional status after TAVR.

Primary outcome measure is altered functional status at six month follow-up defined as an absolute decrease of 15 points of the Barthel Index.

Secondary outcome measures are: Barthel index and survival at 6, 9 and 12 months follow-up. QOL during follow-up

Eligibility Criteria:
Inclusion Criteria:

* Age ≥75
* Symptomatic aortic stenosis
* Prior geriatric evaluation
* Patient who agreed to answer the telephone follow-up to 6, 9 and 12 months
* Patient given his non-opposition to using his data
* Patient affiliated to the French social security.

Exclusion criteria:
Cohort Study of Chronic Heart Failure

The goal of this observational study is to learn about the influencing factors of chronic heart failure prognosis in heart failure patients. The main question it aims to answer is that what are the influencing factors of clinical outcomes in chronic heart failure. Participants will be collected multiple omics data such as phenotype group, environmental exposure group, intestinal microbiome, genome, metabolome, and noninvasive biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years old
2. Dilated cardiomyopathy, hypertensive cardiomyopathy, ischemic cardiomyopathy (coronary heart disease), non-severe valvular heart disease
3. LVEF\<50%, and/or NT-proBNP\>1800ng/L, and/or BNP\>100ng/L, NYHA I-III grade
4. Able to understand and sign informed consent forms

Exclusion Criteria:

1. Expected life less than 3 months
2. Patients with severe renal insufficiency (Ccr\<30ml/min) or undergoing dialysis treatment
3. Cardiac insufficiency caused by various secondary causes that can be corrected includes hyperthyroid heart disease, anemic heart disease, and uncorrected Congenital heart defect
4. Presence of indications for pacemaker implantation and absence of pacemaker implantation
5. Chronic obstructive pulmonary disease with type II Respiratory failure
6. Special populations such as mental illness patients and pregnant women
7. Unable to understand and sign informed consent form
Clinical Assessment of Two Inlay -Retained Bridge Designs

in the last years, dentistry is going to the concept of conservatism to preserve the most amount of tooth structure, so the evolution of new ceramic materials with invasive designs like (inlay- shaped and proximal box shaped) inlay retained bridge, the investigators can restore single missing posterior teeth with less invasive techniques and less rate of restoration fracture.

It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and postoperative sensitivity. In comparison With the inlay-retained bridge, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost

Eligibility Criteria:
Inclusion Criteria:

* Absence of periapical or periodontal or diseases
* sound abutment teeth or with small caries or filling on occlusal or proximal surfaces
* Maintenance of good oral hygiene
* No tooth mobility or grade 1 can be accepted
* Sufficient occluso-gingival tooth height (5mm)
* Good alignment of abutment teeth
* mesiodistal edentulous space preferred not exceed 12mm

Exclusion Criteria:

* Patients under the age of 18 or being incapable of taking out a contract
* Patients with any medical condition that impaired correct oral hygiene
* Endodontic ally treated abutment teeth
* a conspicuous medical or psychological history
* bruxism, or known allergic reaction to the materials used
* limited vertical space for the required connector height of 4mm
* pregnant female patients