cyrilzakka/clinical-trials huggingface dataset:
Formative Research - Developing a Family-based Obesity Prevention Intervention in the Canadian Context

This formative research shows that parents of preschool-aged children are enthusiastic about learning general parenting skills, such as discipline strategies, but that they are less interested in information on child nutrition and physical activity needs. To capitalize on this enthusiasm, Dr. Haines developed Parents and Tots Together (PTT), an intervention that embeds strategies to improve children's nutrition and activity behaviours within an existing general skills parenting program. Results from the investigators feasibility trial with 16 Boston-area parents show that PTT is feasible for implementation and is extremely well-received by parents. Results are also encouraging with respect to changing parent feeding behaviours and children's nutrition and activity behaviours. What is not known is whether this program is feasible and contextually appropriate for Canadian families. Thus, the next step in this research program, and the overall goal of this study, is to assess Parents and Tots Together (PTT), a family-based intervention to prevent obesity among children 3 to 5 years of age, within the Canadian context.

To achieve this goal, the investigators will conduct a pilot trial of the PTT program with 60 families recruited through Ontario Early Years Centres (OEYC). The investigators will randomize 30 families to the 3-month PTT intervention and 30 to a control condition.

The investigators primary objective is to implement and test the feasibility and acceptability of PTT among families with preschool children so appropriate revisions can be made to adapt it to a Canadian context. The investigators secondary objective is to compare the following outcomes among intervention versus control participants:

1. Parent weight-related behaviours (i.e., parent physical activity, intake of sugar-sweetened beverages, and television/video viewing, as well as responsiveness to child satiety cues).
2. General parenting behaviours (i.e., use of positive discipline strategies).
3. Child weight-related behaviours (i.e., sleep duration, physical activity, intake of sugar-sweetened beverages, television/video viewing).
4. Nutritional risk score based on a screening tool for preschoolers.
5. Child change in body mass index (BMI), standardized to age and gender.


Eligibility Criteria:
Inclusion Criteria:

* We will consider eligible all parents who have a child age 2-5 years.

Exclusion Criteria:

* We will exclude: 1) any families who plan to move out of the area during the 9-month study period; and 2) children with severe health conditions that would prohibit them from participating in study activities.
Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain

The purpose of the present study was to evaluate and compare the effects of motor control exercises and standard exercises in the pain, incapacity and medicine intake of subjects with unspecific low-back pain.

Eighty-four subjects with unspecific low-back pain were randomly recruited for the present study. The subjects were randomly allocated into control group (who received one hour of standard physiotherapy exercises every days during ten days) or intervention group (who received one hour of control motor exercises every days during ten days). One month after finishing these ten days, patients should perform a home-based exercises program during two months (control group performed home-based standard physiotherapy exercises; intervention group performed home-based motor control exercises). Pain (visual analogic scale), incapacity index (Roland Morris questionnaire) and medicine intake (diary) were evaluated before the intervention, one month and three months after ending the first ten days of intervention.

Eligibility Criteria:
Inclusion Criteria:

* subjects should be independent to walk
* subjects should have unspecific low back pain during at least the last two months
* subjects should have had at least two recidives of low back pain within the last year

Exclusion Criteria:

* subjects with concomitant pathologies that impede the performance of exercises
* pregnants
* subjects with oncologic pathologies
* subjects with cognitive alterations that impede the understanding of the tests
Vitamin D Supplementation Enhances Immune Response to Bacille-Calmette-Guerin (BCG) Vaccination in Infants

The purpose of this study is to determine whether a single oral dose of vitamin D given to infants prior to Bacille-Calmette-Guerin (BCG) vaccination will enhance the immune response to BCG vaccination.

In 2000, there were an estimated 884,000 cases of tuberculosis (TB) in children with many developing severe, disseminated disease. Widespread immunization with Bacille-Calmette-Guerin (BCG) vaccine has not been effective in preventing primary TB infection or in halting the progression from latent to active disease. Poor vaccine efficacy has prompted investigators to develop novel TB vaccines and to experiment with enhancing the immune response to the current BCG vaccine.

Increasing data indicate that children with low vitamin D levels and specific genetic variants that lower functional levels of vitamin D are at increased risk for severe tuberculosis. Elegant studies investigating Mycobacterium tuberculosis (Mtb) infection have shown that mycobacteria are able to reside in endosomes within macrophages by preventing endosome-lysosome fusion; a critical step in autophagy, a cellular process used to recycle cytoplasmic organelles and proteins, and to degrade microbial organisms including Mtb. In-vitro studies have shown that vitamin D increases autophagy and triggers the production of antimicrobial peptides including cathelicidin. This leads to increased intracellular killing of Mtb and increased Mtb antigen presentation to the immune system. Anti-tuberculous vaccines that over-express Mtb antigens generate a stronger immune response than wild type BCG vaccine.

The investigators hypothesis is that a single oral dose of vitamin D3 (cholecalciferol) given to infants prior to BCG administration will enhance the immune response to vaccination through improved MHC class I and class II presentation of the vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Healthy mothers \> 18 years of age
* Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine

Exclusion Criteria:

* Recent maternal history of tuberculosis (within 1 year) or active tuberculosis
* Known maternal human immuno-deficiency virus (HIV) infection
* Maternal fever or chorio-amnionitis
* Maternal use of vitamin D, steroids or immuno-regulatory medications
* Household member with active tuberculosis
Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 60 (male or female)
* Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years
* Not suitable for liver transplantation or there is no donor liver source
* No serious bleeding tendency or active bleeding
* No hepatic encephalopathy
* After strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score
* Subjects voluntarily participate in this study and sign informed consent

Exclusion Criteria:

* Be less than 20 years old or more than 60 years old
* Cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis C virus and autoimmune hepatitis
* Found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives
* Patients with hypersplenism who need splenectomy
* History of tumors in other organs
* PT prolongation is greater than 3 seconds
* Use of human serum albumin within 3 weeks prior to clinical registration
* Clinically significant upper gastrointestinal bleeding events occurred within 4 weeks before clinical registration
* Spontaneous peritonitis
* Active infection (viral or bacterial)
* Pregnant or lactating women
* The researcher considers it inappropriate to participate in this study
Feasibility of Molecular Biology in Pancreatic Cyst Tumors

The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics.

The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.

Multicenter study to determinate the feasibility of intra-cystic fluid DNA molecular analysis in patients with suspected cystic tumours of pancreas in whom EUS FNA is clinically indicated.

Morphological criteria obtained by MRI and computerised tomography (tumor characterization (size, metastases presence, dilatation of bile ducts), etiologic diagnosis, serious symptoms), biological exams (biomarkers), cytological analysis will lead to a diagnosis and a treatment.

The goal of this study is to compare this standard diagnostic modalities to diagnosis obtained by intra-cystic fluid DNA molecular analysis.

Is the DNA molecular analysis improve the diagnosis accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years of age, male or female
* Cystic tumor of the pancreas requiring a puncture under endoscopic control to determine the etiologic diagnosis and gravity.

Exclusion Criteria:

* Doubts regarding the etiological diagnosis of the pancreatic cyst
* Contraindications for the realization of a high digestive endoscopy
* Haemorrhagic disorder, haemostasis and coagulation disorder (TP \<60%, TCa\> 40 sec and platelets \<60000 / mm3).
* AVK, AOD and AAP cannot be stopped
Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain

The needle stimulation pad is a self-care device, which has been promoted for pain control and well-being. The aim of the study was to test the efficacy of the pad for chronic/recurrent low back pain treatment.

Patients with non-specific chronic or recurrent low back pain were selected from a large health insurance company database and advised to use the pad daily for two weeks; outcomes were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week 2; secondary outcome measures included the Oswestry disability index (ODI), health-related quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic medication consumption and safety.

see above

Eligibility Criteria:
Inclusion Criteria:

* chronic or recurrent low back pain in the past 12 months
* average pain intensity 4 out of 10 points

Exclusion Criteria:

* malignant back pain
* congenital deformities of the spine
* dystonia or other movement disorders
* spinal surgery within 12 months prior
* pregnancy
* dermatological diseases in the areas treated
* tendency for hemorrhages
* severe mental illness
* recent treatment with anticoagulation, corticoid medication, acupuncture
Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

The aim of the study is to compare the effect of a progressive, periodized exercise training designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined effect of exercise and "phytoestrogen" (cimicifuga racemosa; CR). After randomization, 84 females 1-3 year postmenopausal with no medication or illness affecting bone metabolism exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control. Three group training sessions/week will be performed in the EG. Both groups will be individually supplemented with calcium and Vit-D (cholecalciferol).


Eligibility Criteria:
Inclusion Criteria:

* 1-3 years early postmenopausal
* Caucasian race

Exclusion Criteria:

* CHD-diseases
* thrombosis, embolism
* fractures at lumbar spine or hip
* secondary osteoporosis
* hyperparathyroidism
* medication, diseases with impact on muscle or bone
* cancer and hormone derived malign diseases
* weight reduction of \> 5 kg during the last 6 months
CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis

The goal of this study is to enroll caretakers of patients with decompensated cirrhosis to determine if written emotional disclosure or resilience training interventions reduce distress and burden among primary informal caregivers.

Caretakers that meet eligibility will complete baseline assessments in person, or if necessary, over the phone and be randomized to be in one of three arms of this study. Materials specific to each study arm will be mailed to the caretakers home along with instructions. Overall, the study will take approximately 2 months and a qualitative interview will also be completed around 3-6 months post-baseline.


Eligibility Criteria:
Inclusion Criteria:

* Primary informal caregiver for a patient with a clinical diagnosis of decompensated cirrhosis with either of the following three clinical criteria:

  1. Child-Turcotte Pugh (CTP) Class A/B/C cirrhosis with an all cause hospitalization within the previous 30 days.
  2. CTP Class B or C cirrhosis with one of the following within the prior 6 months from the date of enrollment:

     1. Ascites (requiring paracentesis or diuretics)
     2. Overt Hepatic Encephalopathy (requiring lactulose or rifaximin/flagyl/neomycin)
     3. Spontaneous Bacterial Peritonitis (SBP)
     4. Hepatic Hydrothorax (requiring diuretics or thoracentesis)
     5. Variceal Bleed (with 1 or more recurrences)
  3. Hepatocellular Carcinoma (HCC)

     1. Any Barcelona Clinic Liver Cancer (BCLC) Stage with CTP Class B or C
     2. BCLC Stage C or D with CTP Class A

Exclusion Criteria:

* Non-English speaking
* Unable or unwilling to provide verbal consent
* Severe cognitive impairment
* Caregiver is participating in another interventional study
* Caregiver has used a personal diary within the past 12 months
Antibiotic Prophylaxis for Elective Cesarean Section

A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.

comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cesarean section with Gestational age 37 weeks or more

Exclusion Criteria:

1. Fever greater than 38°C or maternal sepsis.
2. Cephalosporin allergy.
3. Exposure to any antibiotic agent within 1week before delivery.
4. Patents having premature rupture of membranes and acute chorioamnionitis.
5. Patients with chronic diseases (diabetes mellitus, renal disease and Cardiac disease).

3) Morbid obesity (BMI\>30)
Effects of Kinesio Taping for Upper Limb Function of Stroke Patients

Patients with stroke in the brain, due to central nervous system damage, lack of correct action patterns, limited joint movement of upper limbs, affecting the patient's performance. The Kinesio taping effect is to facilitate the muscle activity of upper limb. This program is intended to provide a treatment for patients with chronic stroke, and to observe their upper limb movements before and after using the Kinesio taping.

Motor impairment is the main cause of disability after stroke, leading to major health problems. Research has shown that the most common consequence of stroke is the paresis of limbs.The ability to live independently after a stroke depends on the recovery of motor functions,particularly those of the upper limb.The core concept of the Kinesio taping is to influence the brain through the sensory input, stimulate the nervous system, and improve the motor performance of the stroke patient.

Eligibility Criteria:
Inclusion Criteria:

* Post-stroke hemiplegia, at least 6 months since onset
* Ability to communicate and understand instructions.

Exclusion Criteria:

* Skin problems, wounds, or infection on the affected upper limb.
* The experience of using the Kinesio taping.
* A history of allergy tothe Kinesio taping.
Research on the Treatment of Severe Community-acquired Pneumonia in Children

The need for glucocorticoid therapy in children with severe community-acquired pneumonia in the acute phase of the disease remains unclear. The implementation of this study could provide strong evidence on the need for adjuvant glucose therapy in children with severe community-acquired pneumonia.

The use of glucocorticoid for severe community-acquired pneumonia in children is still controversial in clinic. There is still a lack of high quality clinical research results in this field. That's the purpose of this study. The study used oral glucocorticoids and placebos. It was a multicenter clinical study involving 160 people. The enrolled subjects were treated for 5 days after basic assessment, and the use of experimental drugs and changes in clinical manifestations and laboratory examination were strictly recorded. The possible adverse hormonal reactions such as hyperglycemia, hypertension and gastrointestinal ulcer bleeding should be closely monitored and appropriate treatment measures should be taken in time. Subject will be allowed to terminate the test if necessary. Record and discuss similar events. The double blind principle is strictly observed during the experiment to ensure the authenticity and reliability of the experimental data.

Eligibility Criteria:
Inclusion Criteria:

1. 1 month-\< 18 years old.
2. Clinical diagnosis of community-acquired pneumonia (fever, cough, sputum, chest pain, dyspnea, abnormal breath sounds in the lungs, imaging pneumonia changes).
3. Meet any of the following:

   * (1) the general condition is very poor;
   * (2) refusal to eat or dehydration;
   * (3) Significantly increased respiratory rate (70 times/min \> infants, 50 times/min for older children\>);
   * (4) dyspnea (three concave sign, moaning, nasal flapping)
   * (5) hypoxemia (cyanosis, transcutaneous oxygen saturation\< 92% (not oxygenated));
   * (6) Pulmonary infiltration≥ 2/3 lung or multilobar infiltration;
   * (7) There is a pleural effusion;
   * (8) Extrapulmonary complications

Exclusion Criteria:

1. Systemic corticosteroids have been used to treat pneumonia before admission.
2. Use systemic glucocorticoids within 3 months before admission.
3. Hospital-acquired pneumonia.
4. Children with history of tuberculosis, branch expansion, tumors, immune deficiency, congenital heart, chronic pulmonary heart disease, kidney disease, severe malnutrition, recurrent respiratory infections, congenital bronchopulmonary dysplasia (BPD) and other underlying diseases.
5. Unconscious, need endotracheal intubation, children admitted to ICU.
6. Those who are allergic to the drugs or their preparation components involved in the study.
7. Those with hormonal contraindications: hypertension, diabetes, active peptic ulcer, adrenal hyperfunction, corneal ulcer, increased intraocular pressure, severe psychosis.
8. There is a current infection that is difficult to control with antibacterial drugs.
9. Children who are participating in other clinical trials.
10. The investigator believes that it is not suitable to participate in the study.
System Constellations in Virtual Reality (VR)

The purpose of this study is to investigate the efficacy of system constellations in Virtual Reality (VR) in a monocentric, single-masked randomized controlled trial.

The method of system constellations refers to an approach which integrates ideas from organizational and family systems counseling with elements from psychodrama. The constellations are conducted in a group based VR-seminar, each VR-seminar lasting two to three days.

Based on the model of a general mental health, the effects of system constellations in VR on psychological and systems functioning are explored.

It is predicted that participation in a system constellation VR-seminar changes the level of psychological and systems functioning at 4 months.


Eligibility Criteria:
Inclusion Criteria:

* agreement to participate in a 2 to 3-day system constellations VR-seminar
* agreement to be randomized into treatment group or control group (waiting condition)
* agreement not to participate in another system constellation VR-seminar or seminar until completion of study

Exclusion Criteria:

* acute suicidal tendency
* acute psychotic episode
* acute drug or alcohol intoxication
Frequency and Impact of Iron Deficiency in Pain Clinic Patients

The goal of this study is to measure the proportion of patients who have iron deficiency and if iron deficiency is treated what is the outcome. This will be done by testing ferritin and hemoglobin levels of female patients at the DeGroote Pain Clinic and administering the appropriate iron supplementation treatment (oral/infusion) if necessary. Participants will fill out a questionnaire to assess positive impact of iron supplementation treatment.

The study is an observational clinical audit, with an unblinded clinical intervention. Iron deficiency and some chronic pain syndromes like fibromyalgia are more common in women of reproductive age. Iron deficiency can present with symptoms that are similar to those of fibromyalgia, but once recognized, iron deficiency is typically easily treated. We intend to poll patients at the DeGroote Pain Clinic based on information from studies conducted in Australia and Great Britain. We will determine who is at risk for iron deficiency based upon symptoms such as heavy periods, history of pregnancy, blood donation, diet, and any previous iron deficiency. We will then confirm the results with lab testing, and provide treatment if necessary. Our goal is to find out the percentage of women with chronic pain who also have iron deficiency, and assess the effect of treating iron deficiency on their pain symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patient at the DeGroote Pain Clinic
* Menstruating women between the ages of 18-49
* Willingness to complete the questionnaire, and undergo laboratory tests if indicated.

Exclusion Criteria:

* The only exclusion criteria is unwillingness to participate