cyrilzakka/clinical-trials huggingface dataset:
Effects of Delayed Growth on the Quality of Life of Children Treated for a Chronic Disease and Quality of Life Study of Their Parents and Siblings

Chronic childhood diseases have sometimes strong repercussions on the everyday life of patients and their families, because of strict daily treatment regimens, physical limitation or effects on social life for instance In children, chronic diseases can lead to poor growth, which can of itself affect the child's quality of life.

Our proposal is therefore to study the effects of short stature on the quality of life of children with chronic diseases treated in our multidisciplinary paediatrics department.

The quality of life of the patients' relatives will also be considered.

Chronic childhood diseases have sometimes strong repercussions on the everyday life of patients and their families, because of strict daily treatment regimens, physical limitation or effects on social life for instance.

The importance of considering quality of life (an overarching concept covering the effects of the disease on physical, metal, emotional, social and behavioural well-being) in the treatment of patients with chronic conditions is now well established.

Quality of life studies often focus on a specific chronic condition. Studies of multiple chronic pathologies are rarer. However, factors such as the severity of the disease, its prognosis, the constraints of the daily regimen, and the visibility of the disease can have a greater impact than the type of disease itself. Studies of specific chronic diseases have identified several factors affecting quality of life such as age, sex, disease severity, medically unexplained symptoms, family cohesion, socio-economic status, perception of the disease, the adaptation strategies used by the child or their family... It would therefore be interesting to study the effects of these factors on chronic diseases in general, irrespective of disease type.

In children, chronic diseases can lead to poor growth, which can of itself affect the child's quality of life.

Our proposal is therefore to study the effects of short stature on the quality of life of children with chronic diseases treated in our multidisciplinary paediatrics department.

The quality of life of the patients' relatives will also be considered.

Eligibility Criteria:
Inclusion Criteria:

* Age between 8 and 18 years
* Treated in the multidisciplinary paediatrics department of the Timone Hospital
* With a chronic disease (ICD10 definition: for at least 3 months in the current year with no curative treatment available)
* For at least three months
* Requiring at least two hospital consultations per year
* Able to complete the questionnaire
* Able to speak French
* Child and parental consent

Exclusion Criteria:

* Problems understanding the questionnaire (intellectual disability, low French proficiency)
* No social security coverage
The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease

The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and depression in Parkinson's disease. It is well established that exercise improves the motor symptoms of Parkinson's disease. However, it is not clear which types of exercise are most beneficial for specific non-motor symptoms.

This is a multi-site trial (12 patients in each site). The investigators are recruiting 24 patients who will be randomized into either a spinning class, yoga class, dance class, or no exercise intervention. Classes will be conducted twice a week for 6 weeks total at times convenient for the patients. Patients will also be asked to complete questionnaires after exercise classes to see if the exercise intervention improves measures of fatigue, anxiety, and depression - and what exercise intervention may be superior. All participants will be asked to complete questionnaires each week and will be asked to wear a "Microsoft exercise band" during the course of the study. Use of the exercise band is optional.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed with Idiopathic Parkinson's Disease
2. Age between 18 - 75 years
3. Hoehn and Yahr stage less than or equal to 3
4. Mini-Mental State Exam (MMSE) score of over 23 at screening
5. If subjects are taking any medications for depression, fatigue, or anxiety, regimen must be stable for 8 weeks prior to baseline visit
6. Subjects willing and able to give informed consent

Exclusion Criteria:

1. Subjects with a diagnosis of an atypical Parkinsonism
2. Subjects unwilling or unable to obtain Health Waiver from Primary Care Provider
3. Score of 60 or more on UPDRS III at screening
4. Scores in the 'normal' range on all three study assessments: Beck Depression Index II, Fatigue Severity Scale, and Zung self-rating Anxiety Scale
5. Participation in any of the 3 physical activities more than 3 times in the past for 8 weeks prior to baseline
6. Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study
Glycemic Response of a Commercial Food Bar

The purpose of this study is to examine the glucose and insulin response to a food bar.

Fitjoy is a commercially available food bar marketed as having a low glycemic index and being relatively high in dietary fiber. The fiber contained within this product is isomalto-oligoshaccaride (IMO) which is a food ingredient with a relative sweetness level equal to approximately 60% of sucrose. Chemically, IMO is a mixture of glucose oligomers with alpha - (1-6) - linkages. To date, no research has been performed on the glycemic response to ingesting IMO in combination with other constituents. Therefore the purpose of this study is to determine the glycemic index of the Fitjoy bar.

Eligibility Criteria:
Inclusion Criteria:

* Participant is between the ages of 18 and 35
* Participant is apparently healthy
* Participant is moderately active and participants in low intensity recreational activity at lease 3 to 4 days a week
* Participant has a BMI \< 24.9

Exclusion Criteria:

* Participant has a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmais, cardiovascular disease
* Participant uses current prescription medication (birth control is allowed)
* Participant is pregnant or nursing or plans to become pregnant during the next month
* Participant has an intolerance to caffeine and/or other natural stimulants
* Participant has a history of smoking
* Participant drinks excessively (i.e., 12 drinks per week or more)
The Effect of Inspiratory Muscle Training on Blood Pressure and Functional Capacity in Elderly With Hypertension

The goal of this clinical trial is to investigate in elderly with hypertension . The main question it aim to answer is:

• Investigate the effect of inspiratory muscle training on inspiratory muscle strength, blood pressure and physical capacity

Participants will be random in to 2 group and measure baseline. Control group will advise to maintain normal daily life activity. and Intervention group will receive inspiratory muscle training (IMT) with 60% of Maximal inspiratory pressure. Intervention group will perform IMT 30 breaths/day, 5 days a week for 6 weeks.

after 6 weeks both group will remeasure variable again as post test


Eligibility Criteria:
Inclusion Criteria:

* Elderly with hypertension
* BMI 18.5 - 29.9 kg/m2

Exclusion Criteria:

* Unstable angina
* Resting heart rate more than 120 bpm
* Resting blood pressure more than 180/100 mmHg
* Other abnormality with contribute to IMT and variable measurement
MRA Therapy Versus CPAP Therapy in Moderate OSAS

The purpose of this study is to compare the cost-effectiveness and effectiveness of mandibular repositioning appliance (MRA) versus Continuous positive airway pressure (CPAP) therapy in patients with moderate Obstructive Sleep Apnea Syndrome (OSAS).

Study design: In a randomized parallel controlled study 86 patients will be randomly assigned to either MRA therapy or CPAP therapy. Group A receives MRA. Group B receives CPAP. The total duration of the study is 12 months. Measurements will be done at baseline, after 3, 6 and 12 months.

Intervention: Group A will be treated with a bibloc MRA (Somnodent). The mandible will be set at 70% of the patient's maximum advancement and will be adjusted to the convenience of the patient. Titration will be continued until symptoms abate or until further advancement causes discomfort.

Group B will be treated with CPAP. Proper CPAP-pressure will be set for each patient separately. Patients are fitted with a comfortable CPAP mask before titration of the CPAP-pressure. For CPAP-titration, patients are instructed to adopt their own typical sleeping habits.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have been subjected to polysomnography and are diagnosed as having moderate (AHI 15-30) OSAS;
* Aged ≥ 18 years;

Exclusion Criteria:

Medical and psychological criteria:

* Patients previously treated for OSAS (e.g. CPAP, MRA);
* Morphologic abnormalities of the upper airway (e.g., a compromised nasal passage, enlarged tonsils or adenoids, or upper airway soft-tissue or craniofacial abnormality);
* Reported or documented unstable endocrine dysfunction (hypothyroidism, acromegaly, or pituitary adenoma); Reported or documented severe cardiovascular- or pulmonary co-morbidity
* Clinically concurrent cardiovascular disease (coronary artery disease, heart failure,cardiac arrhythmias)
* CVA within 6 months prior to randomisation
* Daytime respiratory insufficiency
* Severe Chronic Obstructive Pulmonary Disease (COPD) (GOLD 3 or 4; FEV1 / FVC \< 70% and FEV1 \< 50%);
* Other diseases that may impact the evaluation of the results of the study according to the investigator's judgement.
* Reported or documented psychological condition precluding informed consent (e.g., mental retardation, depression or schizophrenia);

Whether the patient has unstable endocrine dysfunction, severe cardiovascular- or pulmonary co-morbidity or a psychological condition precluding informed consent, will be assessed by evaluating the patient's medical record.

Dental exclusion criteria:

* Extensive periodontal disease or tooth decay;
* Active temporomandibular joint disease (including severe bruxism);
* Restrictions in mouth opening (\< 25mm) or advancement of the mandible \<5mm);
* Partial or complete edentulism (less than eight teeth in upper or lower jaw).
A Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of SLN124 in Healthy Volunteers

This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.

This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN124 after single ascending s.c. doses in healthy male and female subjects.

Up to 3 cohorts of 24 healthy volunteers will be enrolled. Each subject will receive a single dose of SLN124 or placebo given by subcutaneous (s.c) injection.

Eligibility Criteria:
Inclusion Criteria:

* Normotensive male or female volunteers, with a body mass index of 18.0-30.0 kg/m2.
* Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine.
* Agree to follow the contraception requirements of the trial.
* Able to give fully informed written consent.
* Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.

Exclusion Criteria:

* History or presence of iron deficiency or iron deficiency anaemia and/or currently receiving oral or parenteral iron supplementation as treatment for those conditions.
* Positive tests for hepatitis B \& C, HIV
* Drug or alcohol abuse.
* Smoke more than 10 cigarettes (or equivalent) daily.
* Use of over-the-counter medication (with the exception of paracetamol \[acetaminophen\]) during the 7 days before the first dose of trial medication, or prescribed medication (with the exception of hormone replacement therapy \[HRT\]) during the 28 days before first dose of trial medication.
* Use of supplement(s) during the 28 days before screening.
* Participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months.
* Clinically relevant abnormal medical history or concurrent medical condition.
* Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception.
Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis

Aim: validate a Dual Integrated Attention Program (D-AIP) for mental health nursing in people with Severe Dual Diagnosis admitted to a psychiatric hospitalization unit

Design: Randomized Controlled Trial. Population: Inpatients with dual diagnosis.

The main objective of the project is to validate a Dual Integrated Attention Program (D-AIP) for mental health nursing in people with Severe Dual Diagnosis admitted to a psychiatric hospitalization unit, assessing change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety, which this context generates. For this purpose, a randomized, prospective, one-year-longitudinal clinical trial will be conducted. This study will be applied on patients with diagnosis of schizophrenia, schizoaffective disorder and bipolar disorder types I and II who, after accepting to participate in the study and signing the informed consent, answer the PRISM questionnaire of admission in the hospitalization unit and fulfill the dual pathology criteria. After, they will be randomized in control group and intervention group (only the later will complete the D-AIP).

The D-AIP will consist on 6 individualized sessions with the psychiatric inpatients, and during follow-up up to one year after discharge in which 4 individual sessions and 3 telephone contacts will be made. In both groups, a different person from the one who performs the intervention and without knowledge of the group belonging will assess them with questionnaires in 9 moments during the whole follow-up year (Socrates 8D, Scale of Unawareness of Mental Disorder "SUMD", Morisky Medication Adherence Scale "MMAS-8", Working Alliance Inventory "WAI", Hamilton Anxiety Rating Scale "HARS" y Hopelessness Scale "HS") and will collect a urine sample in each evaluation. The sample size will be 86 subjects, for α=0.05 and power=0.80.

Eligibility Criteria:
Inclusion Criteria:

1. Inpatients diagnosed with some serious mental illness of the following:

   * Inpatients with diagnosis of schizophrenia
   * Inpatients with diagnosis schizoaffective disorder
   * Inpatients with diagnosis bipolar disorder types I
   * Inpatients with diagnosis bipolar disorder types II
2. Consumption of addictive substances

Exclusion Criteria:

* Intellectually Disabled
Effect of Motor Imagery Training on Ataxic Children After Medulloblastoma Resection

Background: after resection of medulloblastoma in children they suffer from signs and symptoms of ataxia which impedes their activities of daily living.

purpose: to investigate the effect motor imagery training on balance, severity of ataxia and gait parameters on children after resection of medulloblastoma.

Methods: Fifty children surfing from cerebellar ataxia after medulloblastoma resection were selected from tumors hospital of Cairo University, their age ranged from seven to nine years old, they were randomly assigned into two matched control and study groups. The control groups received the selected physical therapy program while, the study group received motor imaginary training in addition to the selected physical therapy program. Both groups were evaluated by ataxic rating scale, pediatric berg balance scale and kinematic gait analysis by kinovea software.

Motor imagery is an effective method to enhance motor performance applied in rehabilitation programs it did not impose a physical load on patients, was confirmed through clinical evidence from meta-analysis. Motor imagery means thinking in motor task with executing it to activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by thinking.

Eligibility Criteria:
Inclusion Criteria:

* The children had signs of ataxia
* loss of balance
* able to understand and execute test instructions
* the children are in the follow up period after medulloblastoma resection.

Exclusion Criteria:

* medically unstable
* visual impairment
* increased intracranial pressure
* any other neuromuscular diseases.
A Study of NPC-22 in Healthy Adult Males

The purpose of this trial is to examine the safety and pharmacokinetics of NPC-22 administered in a single ascending dose in healthy adult males.

The healthy adult males will be randomized into six arms, and will receive single dose of NPC-22 (five doses, placebo)

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have provided their own written informed consent
2. Subjects aged ≥20 and \<40 years at the time of informed consent
3. Subjects with body weight of ≥50 kg and body mass index (BMI) (kg/m2) of ≥18.5 and \<25.0
4. Subjects who were identified to have no health problem on physical examination, physical assessment, laboratory tests, or other examinations at screening by the principal investigator or a sub-investigator

Exclusion Criteria:

1. Subjects with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence
2. Subjects with a history of severe disease that may recur during the study period
3. Subjects with any concurrent illnesses
4. Subjects who received another study drug within 180 days prior to the start of study drug administration
5. Subjects who donated blood of ≥400 mL within 12 weeks, blood of ≥200 mL within 4 weeks, or blood components within 2 weeks prior to the start of the study
6. Subjects who used any medicinal product (including over the counter drugs except for topical products) or similar product like a dietary supplement (including health food) within 7 days prior to the start of study drug administration
7. Subjects who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration
8. Subjects who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration
9. Subjects who smoked within 90 days prior to the start of study drug administration, or do not agree to stop smoking during the study period
10. Subjects who had a positive result for HBs antigen, HCV antibody, or HIV antigen/antibody, or a positive reaction to syphilis serology or urine drug test at screening
11. Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator based on the 12-lead electrocardiogram at screening \[e.g., Fridericia's corrected QT (QTcF) interval of ≥450 ms\]
12. Subjects who have a familial history of torsades de pointes or long QT syndrome
13. Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator by having a deviation from the institutional reference values
14. Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons
Evaluation of the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty

Autologous glue therapy with platelet-rich plasma (PRP) was reported to improve outcomes in plastic surgery. However, only pilot studies and retrospective uncontrolled trials have reported the potential benefits of autologous glue treatment up to now. Therefore, a larger, blinded, randomized and placebo-controlled clinical trial would be useful to determine whether platelet-rich plasma is safe and effective in abdominoplasty procedures.

Currently, there are pharmacological options such as artificial fibrin glues composed of homologous fibrinogen and animal-derived thrombin. However, these therapeutics present a risk of transmissible diseases and may induce allergic reactions. Therefore, autologous glues, which are fully made of blood components from the patient itself (autologous fibrinogen contained in PRP and autologous thrombin) represents a safe alternative to artificial biological glues.

Regen Lab SA developed RegenKit®-Surgery to prepare autologous PRP, on one hand, and an autologous activated thrombin serum, on the other hand, in a safe and rapid manner. RegenKit®-Surgery is a CE-marked class IIb medical device.

This study, conducted on 56 patients, will evaluate the effects of autologous glue prepared with RegenKit®-Surgery when used in reconstructive abdominoplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with an indication for abdominoplasty
* Signature of informed consent form
* Capable of understanding the study's imperatives

Exclusion Criteria:

* Participation -ongoing or in the last two months- in another clinical trial
* Pregnancy or breastfeeding
* Auto-immune disease (e.g. Hashimoto, rheumatoid arthritis, lupus, etc.)
* Hereditary or acquired hematologic disorder (e.g. drepanocytosis, etc.)
* Haemoglobin \< 10g/dl
* Haematocrit \< 33%
* Hereditary or acquired coagulation disorder (e.g. platelet dysfunction syndrome, critical thrombocytopenia with a platelet count \< 150'000/microlitre, impaired coagulation,etc.)
* Systemic disorders such as diabetes, or hepatitis
* Acute infection
* Any active malignancy
* Chemotherapy
* Refusal or incapacity to give Informed Consent
A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms

The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery. Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders. The management of pain after surgery in adults taking buprenorphine can be challenging, as buprenorphine may interfere with the effectiveness of other medications used to treat pain.

We want to compare how well pain is managed after surgery ("post-op") in two groups:

The "Continue Group": those who continue taking their standard dose of buprenorphine before, during and after surgery.

The "Reduce Group": those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, you will be put back on your full dose of buprenorphine.

We also want to find out if there is a difference in pain, opioid cravings, and relapse rates in the month following surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) health class I-III
* Currently taking buprenorphine or buprenorphine/naloxone daily at a dose of at least 16mg per day for at least the prior 30 days for treatment of Opioid Use Disorder by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
* Scheduled for surgery at Massachusetts General Hospital where greater than 3/10 pain is expected on post-operative day 1

Exclusion Criteria:

* Participants unable to consent to the study
* Renal insufficency with a glomerular filtration rate \<30ml/min (participants would be unable to use ketorolac which is a part of the multimodal anesthetic plan)
* Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score \> 25 (participants would be unable to use Tylenol which is part of the multimodal anesthetic plan)