cyrilzakka/clinical-trials huggingface dataset:
Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes

A brief, nurse-led educational intervention using motivational interviewing substantially improved general and disease-specific self-management skills in youth with type 1 diabetes.

Introduction and Objectives: For youth with chronic health conditions, adolescence is associated with a deterioration of disease self-management and poor health outcomes. Effective interventions are needed to prepare youth for transition to adulthood and adult care. To prospectively assess the impact of an education program based on motivational interviewing on self-management skills and glycemic control in youth with Type 1 diabetes (T1D).

Methods: After parental consent and youth assent, investigators prospectively randomized 66 adolescents 13-18 years old with type 1 diabetes to either usual care (regular medical consultation) or usual care supplemented by sessions with a nurse educator using a motivational interviewing (MI) approach and goal setting based on responses to the Transition Readiness Assessment Questionnaire (TRAQ) and T1D specific self-management skills. Primary outcomes were TRAQ change scores and HbA1c levels between baseline and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with type 1 diabetes
* Having an age between 13 and 18 years

Exclusion Criteria:

* Having a neurological disability (epilepsy, autism)
* Having a significant intellectual delay, which might have affected their ability to understand the content of the program
Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs

This Study evaluates the effect of 20 weeks of isometric handgrip (IHG) home training in adults aged 50 years or more. Half of the participants will serve as a control group and will only receive hypertension-guidelines on lifestyle changes.

Hypertension markedly increases the risk of cardiovascular diseases and overall mortality. Lifestyle modifications such as increased levels of physical activity are recommended as the ﬁrst line of anti-hypertensive treatment. A recent systematic review showed that isometric handgrip (IHG) training was superior to traditional endurance and strength training in lowering resting systolic blood pressure (SBP). The average length of previous IHG training studies is approximately 7.5 weeks with the longest being 10 weeks. Therefore, presently it is unknown if it is possible to further lower blood pressure levels beyond the 10 week mark. Recently, the investigators developed a novel method for monitoring handgrip intensity using a standard Nintendo Wii Board (Wii). The primary aim of this study is to explore the effects of 20-weeks IHG home training facilitated by a Wii in hypertensive older adults (+50 years of age) in lowering SBP compared to usual care. Secondary aims are to explore if/when a leveling off effect on SBP will occur during the 20-week intervention period in the training group and to explore adherence and potential harms related to the IHG home training.

Methods: Based on previous evidence, the investigators calculated that 50 hypertensive older adults (+50 years of age) is needed to achieve a power of 80% or more. Participants will be randomly assigned to either an intervention group (IHG home training + hypertension-guidelines on lifestyle changes) or to a control group (hypertension-guidelines on lifestyle changes). Participants in the intervention group will perform IHG home training (30% of maximum grip strength for a total of 8 min per day per hand) three times a week for 20-weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age +50 years old
2. Un-medicated (anti-hypertensive medicine) with resting SBP between 135-179 mmHg or hypertensive patient medicated with no change in treatment for ≥ 4 months with resting SBP between 135-179 mmHg

Exclusion Criteria:

1. Manifest cardiovascular disease (cerebrovascular disease, Heart failure, Chronic Kidney Disease, peripheral vascular disease, and advanced retinopathy (fundus hypertonus III-IV)).
2. Diabetes (any type)
3. More than three blood pressure regulating agents
4. Physical limitation preventing IHG training (e.g. missing an arm or musculoskeletal disorders).
5. Arthritis in the hand or carpal tunnel
6. SBP ≥ 180 mmHg (will be advised to see a doctor)
Lifestyle Intervention Treatment for Patients With Mild Obstructive Sleep Apnea

The main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild OSA.

Obstructive sleep apnea (OSA) is one of the most common sleep disturbances, and it has been estimated that one out of five adults has at least some degree of sleep related breathing disturbances. Obstructive sleep apnea affects mostly the middle-aged work force, and causes a negative impact on public health by increasing both morbidity and mortality. Obesity is related to many diseases including diabetes, cardiovascular diseases, and metabolic syndrome,and obesity is also considered as the most important risk factor for OSA.Considering the prevalence of mild OSA, and the beneficial effects of even a slight weight loss on both the severity of OSA and the likelihood of developing OSA, lifestyle intervention including weight reduction represents a viable option for the treatment of patients with mild OSA.However, although included in the clinical guidelines, there is a definite lack of well executed studies on the effect of weight reduction upon OSA. Accordingly, we are conducting a randomized study on the effects of lifestyle intervention in the most prevalent subgroup of OSA patients, overweight patients with mild OSA. The study is an on-going prospective, randomized, parallel group trial. The main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild OSA.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Apnea-hypopnea index 5-15
* BMI 28-40
Study of Nutritional Suitability of a New Infant Formula for Term Infants

This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.


Eligibility Criteria:
Inclusion Criteria:

* Healthy full term infant (37-42 weeks of gestational age)
* Birth weight 2,500 to 4,500 g
* Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation
* Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary
* Informed consent signed by parent(s)/caregiver(s)

Exclusion Criteria:

* Congenital illness or malformation that may affect infant feeding or normal growth
* Gastrointestinal disorders
* Suspected or known allergy to milk protein for formula groups
* Known food allergies in parents or siblings for formula groups
* Multiples
* Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment
* Infant participating in another clinical study
* Infant's family unable to comply with the protocol according to the investigators's assessment
The Efficacy of Induction and Adjuvant Camrelizumab Combined With Chemoradiation for LA-HNSCC

This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.

All participants from 3 hospitals will receive induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4\~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥18 years of age.
2. ECOG Performance Status 0 or 1.
3. Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus.
4. Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease.
5. Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy.
6. With measurable target lesions by CT or MRI.
7. Adequate bone marrow function.
8. Adequate renal and liver function.
9. Pregnancy test (for patients of childbearing potential) negative at screening.
10. Signed Written Informed Consent.

Exclusion Criteria:

1. Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
2. Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded).
3. Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment.
4. Pregnancy or breast feeding.
5. Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
6. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
7. Has received a live vaccine within 4 weeks of planned start of study therapy.
8. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
Prophylactic PIPAC in Patients with High-risk Colorectal Cancer

In patients with colorectal cancer at high risk for metachronous peritoneal carcinomatosis (pT4 pN0-2 cM0 pMMR colorectal cancer of the colon, colorectal junction or high rectum and/or with positive cytology), we will compare standard surgery (consisting in removal of the primary cancer) followed by 3 months of adjuvant chemotherapy + 3 cycles of oxaliplatin-based PIPAC (4-6 weeks apart), to standard surgery followed by 3 months of adjuvant systemic chemotherapy, in terms of 1-year peritoneal metastasis-free survival, 3-year.


Eligibility Criteria:
Inclusion Criteria:

* Patients operated (in emergency or elective surgery) for colorectal cancer (of the colon, colorectal junction or high rectum).
* Definitive pathological stage pT4 pN0-2 cM0 pMMR and/or pT4 pN0-2 cM0 pMMR with positive cytology and/or pT4 pN0-2 M1c pMMR with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and not other distant lesion
* Performance status 0-1.
* Age \> 18 years.
* Written informed consent.

Exclusion Criteria:

* Age \<18 year old.
* Hereditary colorectal cancer.
* Inflammatory bowel disease.
* Distant metastasis (outside limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and not other distant lesion.
* Neo-adjuvant treatment.
* Pregnancy or lactation.
* Immunosuppression.
* Unable to provide informed consent.
* Previous cytoreductive surgery (CRS).
* Contraindication to laparoscopy (e.g. severe adhesions, peritonitis).
* Contraindication to and/or no adjuvant chemotherapy.
* History of allergic reaction to oxaliplatin or other platinum containing compounds.
* Renal impairment, defined as GFR \< 50 ml/min, (Cockcroft-Gault Equation).
* Myocardial insufficiency, defined as NYHA class \> 2.
* Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
* Inadequate haematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
* dMMR/MSI colorectal cancer.
A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1

The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* CD4 cell count greater than 50 cells/mm\^3
* HIV-1 RNA viral load greater than or equal to 5000 copies/mL
* Patients must be HIV treatment experienced
* Patients diagnosed with HIV-1 infection

Exclusion Criteria:

* Female patients must not be able to have children or must be under effective contraceptives
* Female patients who are pregnant
* Have taken enfuvirtide and/or T-1249 before
* Have serious kidney problems
* Alcohol and/or drug abuse
* Have had an organ transplant
Visual Feedback Non-weight Bearing Exercise on the Elderly With Knee Osteoarthritis.

Degenerative knee arthritis is the most common chronic arthritis disease. Once the elderly suffer from this disease, it will accelerate the loss of body function and autonomy. strength performances and maintain are the most important functional performances of lower extremities, especially in walking and balance in daily activities for elderly people with osteoarthritis(OA) of the knee. However, combining the exercise and visual feedback may promote the muscle strength and functional performances of lower limbs, facilitating the muscle strength, motor and boady functional performances for elderly adults after OA knee. Therefore, the purpose of this proposal is to investigate the changes in muscle strength and physical fitness of lower limbs in older adults following OA knee after visual feedback non-weight bearing exercise intervention.

Backgroud:In clinical observation, aging leads to a gradual degeneration of the neuromuscular system, decreasing the muscle strength and functional performances of lower extremities. Muscle strength performances and maintain are the most important functional performances of lower extremities, especially in walking and balance in daily activities for elderly people with osteoarthritis(OA) of the knee. However, non-weight bearing exercise combing visual feedback may promote functional performances of lower limbs, facilitating the muscle strength for elderly people with OA knee.

Purpose: Therefore, the purpose of this proposal is to promote muscle strength and physical fitness after visual feedback non-weight bearing exercise intervention.

Method:After recruiting 40 elderly people with degenerative knee arthritis, they were randomly assigned to the experimental group and the control group .The experimental group conducted visual feedback under the guidance of Labview software, and used rowing machine equipment for resistance exercise training.The training time of the two groups is 12 weeks, twice a week, 30 minutes each time, a total of 24 times.Before and after exercise training , both groups used the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to understand their self-response of knee(pain、stiffness functional)；used MicroFets3 to measure hip and knee muscle strength；Elder Functional Fitness chose Chair stand test、Functional reach test、10m-Walking time are used to understand the body function.

Stastistical analysis:Data were analyzed with SPSS18.0. Paired Sample t-test and Independent-Sample T Test were used to determine the between-groupand within-group differences on all outcome measures. The statistical significance level was set at a (p\<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of degenerative knee arthritis.
* Must be able to stand up and sit down.

Exclusion Criteria:

* surgery on the knee or hip joint.
* rheumatoid arthritis and uarthritis in past six years.
* lower limb fractures
* neurological diseases,e.g.,stroke、parkinson's disease
* injected hyaluronic acid into the knee joint in the past two months
* severe cardiovascular and heart failure.
The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings

The goal of this clinical trial is to optimize hearing aid benefit based on the individual auditory-cognitive need using different hearing aid features in first-time hearing aid users between 45-80 years old with bilateral Phonak Audéo Paradise/Lumity 70 hearing aids. The main questions it aims to answer are:

Does cognitive functioning affect hearing aid benefit? How can hearing aid fitting be optimized based on the individual auditory-cognitive profile?

The hypothesis posits that cognitive abilities influence the effectiveness of hearing aids, alongside hearing status. Furthermore, if features of hearing aids improve speech understanding and listening effort, it is proposed that individuals with lower cognitive functioning will experience heightened benefits from hearing aids.

The study will consist of three groups: one control group and two groups where one different feature will be modified.

Participants will be tested at baseline measurement, including:

* screening tests
* audiological tests
* questionnaires
* cognitive tests
* real-ear-measurement

Following this, participants will be divided in one of the three groups, after which speech audiometry will be repeated. After a 4-week acclimatization period, the second measurement will take place, repeating speech audiometry and questionnaires. Subsequently, the hearing aid settings will be restored to their initial configuration.


Eligibility Criteria:
Inclusion Criteria:

* Dutch-speaking individuals aged between 45-80 years old
* individuals with normal vision (with glasses or lenses if needed)
* individuals with age-related hearing loss
* individuals with bilateral hearing aids (Phonak Audéo Paradise/Lumity 70)
* individuals who are capable to give consent to participate in the study themselves

Exclusion Criteria:

* user of cochlear implants
* use of influencing medication (for example: Rilatin and antidepressants)
* learning disabilities (for example: dyslexia and dyscalculia)
* (history of) neurological problems (brain tumor, epilepsy, history of stroke, ...)
PEF-Block & Ribs Fractures

Rib fractures are frequent injuries found approximately in 10% severe trauma patient. Rib fractures were correlated in many studies with a higher morbidity and mortality. This impaired outcome is mainly due to pulmonary complications consequences including especially pulmonary contusions. Frequently, patients present difficulty deep breathing and coughing. These adverse effects can lead to the development of atelectasis, hypoxia, and respiratory failure with mechanic ventilation recourse. Effective pain management may prevent these complications and reduce the likelihood of developing chronic pain. A multi-modal analgesia regimen is widely employed combining regional and systemic analgesia. Epidural analgesia is considered by many authors to be the gold standard of pain relief although many side-effects are frequently describe including hypotension, urinary retention nausea and vomiting. Paravertebral nerve blockade is an adequate alternative that provide similar quality of analgesia with lower incidence of complication. However, the failure rate associates with PVB is about 13% and it may be associated with hypotension (4.6%), accidental vascular puncture (3.8%), accidental pleural puncture (1.1%) and rarely pneumothorax (0.5%). Recently, a description of the intercostal paraspinal nerve block. This technic was performed for patients undergoing thoracic surgery without complications.More recently, a description of a new approach to provide thoracic analgesia named the Posterior Paramedian subchoroidal (PoPS) block. The authors consider this technique provide an analgesia of the anterior and the posterior branch of adjacent thoracic nerves. The investigators propose to investigate the effect of Posterior exothoracic fascial block.


Eligibility Criteria:
Inclusion Criteria:

* Major patients (18-80 years old)
* Affiliated to the social security
* Hospitalized following severe trauma associated with at least 2 unilateral ribs fractures
* EVA greater than or equal to 3 when coughing or when mobilizing care.
* Management of the patient in the first 24 hours post trauma.
* Patient not intubated.
* Collection of informed written consent, notification on the anesthesia sheet.

Exclusion Criteria:

* Minor patients,
* Patients under guardianship
* Pregnant or lactating women
* Allergy known to local anesthetics,
* Severe coagulopathy,
* Infection of the puncture site
* Neuromuscular pathology
* Chronic pain patients (long-term treatment with non-inflammatory steroidal, opioid, neuroleptic, antidepressant, antiepileptic),
* Intubated patient
VENUS: Septic Gene Expression Using SeptiCyte

The investigators seek to evaluate a new test for determining presence of infection/sepsis as compared to non-infection/systemic inflammatory response syndrome among critically ill patients within the first 24 hours of their being hospitalized in an intensive care unit (ICU) within the first 7 days of hospitalization. The primary purpose of the study is to validate SeptiCyte® Lab in this population as compared to: 1) the doctor's impression and 2) existing clinical parameters. The investigators also hope to assess how well a related, new blood test, SeptID® identifies different types of infection, as compared to cultures and other lab tests.


Eligibility Criteria:
Inclusion Criteria:

1. 18-89 years old on the day of ICU admission
2. SIRS present as defined by the presence of two or more of the following:

   * Temperature \> 38°C or \< 36°C
   * Heart Rate \> 90 beat/min
   * Tachypnea \> 20/min or PaCO2 \< 32 mmHg
   * White Blood Cell count \> 12 000/mm3 or \< 4 000/mm3 or \> 10% immature neutrophils (bands)

Exclusion Criteria:

1. Consent not provided
2. Age less than 18 or greater than 89 years old on the day of ICU admission
3. Not admitted to ICU
4. Clinical cultures or serologies not obtained
5. Subject has been admitted to study hospital (or transferring facility) for ≥ 24 hours
6. Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours.
7. Patients on non-prophylactic antibiotics for more than 24 hours prior to ICU admission
8. Delay of \>24 hours between trial enrollment and sample draw time
9. Ethnic/racial category has completed enrollment.
Prevention and Control of Obesity in Primary School Children in Tehran

This study evaluates the effect of an interventional model for preventing and controlling overweight and obesity in male and female fifth-graders. First, based on WHO (World Health Organization) references obese (BMI-Z score ≥ 2) and overweight (BMI-Z score ≥ 1) students from 12 primary schools (randomly allocated to 6 intervention and 6 comparison) will be screened. Then from the screened students 30 students with the following inclusion criteria will be recruited: not metabolically ill, not on a weight losing diet and not professionally athlete. For selected students BMI-Z score as primary outcome will be calculated. Demographic data, as well as data on waist and hip circumference, triceps skin-fold thickness, food intake for 3 days (2 ordinary week days and 1 weekend) and physical activity will be collected at the beginning and at end of the 6-month intervention. The approach of the study will be Health Promoting Schools. The intervention includes three components, i.e., nutrition education (students and parents), increased physical activity, and changing environment (food items offered in schools' canteens). Nutrition education will be imparted (a 30-minute session per week) by health instructors; physical activity will be done under the supervision of the school coaches (2 one-hour sessions per week). Parents' education (a 1.5-hour session) will be monthly. Finally the efficacy of the intervention will be determined and reported.


Eligibility Criteria:
Inclusion Criteria:

* BMI-Z-Score\> or =1 (WHO)
* Students in the fifth or sixth grades

Exclusion Criteria:

* Metabolic disorders (hypo or hyperthyroidism)
* Any disease which interfere with adherence to the intervention
* Intake of any appetite-reducing drug
* Doing professional sports
* Being on a weight reduction diet