cyrilzakka/clinical-trials huggingface dataset:
B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss

The purpose of this study is to carry out a field trial to evaluate the effectiveness and added value of the b-SLIM digital Super Coach in a convenient sample of overweight and obese adults.

The purpose of this study is to carry out a field trial to evaluate the effectiveness of the b-SLIM digital Super Coach in a convenient sample of overweight and obese adults. The effectiveness will be evaluated at the individual level by means of a randomized trial. By combining or not combining the use of the b-SLIM digital Super Coach with a conventional physical activity and nutrition coaching, the effectiveness of the Super Coach of the (user-driven) 'Super Coach' compared to a conventional face to face weight loss program can be determined. Outcomes will be measured at the level of health behavior (i.e., physical activity and nutrition), body composition, physical fitness, psychosocial factors (e.g., motivation) and program adherence. The field trial will take place in Leuven (Belgium).

This study can be seen as a pilot trial. The central hypothesis of this field trial is that using the multi-source b-SLIM digital Super Coach will support and assist overweight and obese adults to change their health behavior (i.e., physical activity and nutrition) and to lose body weight by improving their self-control, self-determined motivation and attitude towards regular physical activity and healthy diet. The investigators will check if the Super Coach can be a valuable alternative for a conventional physical activity and nutrition coaching.

Eligibility Criteria:
Inclusion Criteria:

* Living in the region of Leuven
* Middle-aged (from 18 to 65 years)
* Having a body mass index between 29-34 kg/m²
* Having an e-mail address
* Having a personal computer

Exclusion Criteria:

* Suffering from a known physical (e.g., orthopedic limitations, stroke, etc.) and/or psychological (e.g., anorexia, bulimia, depression, etc.) disease or co-morbidity
* Intake of any medication with possible impact on body weight, endurance capacity
* Currently treated for diabetes (both Type 1 \& 2).
* No sleepapneu has been determined during the last year.
* Having a history of systematic strength or endurance training (moderate to high intensity training more than once a week) in the year before the beginning of the trial
* Having a history of following a supervised dietary advice in the year before the beginning of the trial
* Having a history of bariatric surgery or any other malabsorption-related disease.
* Pregnancy
Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Optic neuritis (ON) represents around 30% of clinical presentation of clinically isolated syndrome (CIS). Asymptomatic optic nerve involvement is very frequent in all stage of multiple sclerosis (MS) disease including the CIS. However, optic nerve is still not part of MS diagnosis criteria. The main objective of our regional and multicenter study is to evaluate the prognostic value of optic nerve involvement at the earliest clinical stage of MS (=CIS) for the diagnosis of clinically definite MS (2nd clinical relapse) and the delay until the 2nd relapse.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 55 years old
* Occurrence of CIS ≤ 6 months
* With two T2 hypersignals on brain/spinal cord MRI suggestive of MS or with oligoclonal bands
* Giving their written informed consent

Exclusion Criteria:

* Pathological conditions that may skew the optic nerve MRI and/or retinal OCT (diabetes mellitus, glaucoma, retinopathy, ametropia \>6 dioptria)
* Past history of MS relapses
* Extensive myelitis (\>3 vertebral bodies)
* Bilateral optic neuritis without T2 lesions suggestive of MS
* Contra-indication to MRI, gadolinium injection
* Pregnancy, breast-feeding
* Patients unable to consent
Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.

This phase 2 trial will explore the efficacy of a single dose of vinblastine (6mg/m2) to leukoreduce patients with newly diagnosed AML and hyperleukocytosis. Patients will be allocated 1:1 into two groups: intravenous single dose vinblastine or oral hydroxiurea (50mg/kg/day until response or induction chemotherapy). Effective leukoreduction and safety parameters will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Both genders
3. Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria
4. Patients eligible and not eligible for transplant
5. Patients eligible and not eligible for intensive treatment
6. AML secondary to treatment or associated to myelodisplasia
7. Leukocytes ≥50x106/L
8. Not being able to receive chemotherapy in the next two days

Exclusion Criteria:

1. AML with PMP/RAR-alfa translocation t(15;17)
2. Poor functional status (ECOG\>2)
3. Active infection
4. Pregnancy
Hands On Nutrition Education to Improve Childhood Health

The main goals of this study is to better understand how an experiential cooking, movement and mindfulness intervention influence elementary school children at Spring Valley School. program diet, fitness, metabolic outcomes, health literacy and overall well-being. Specifically, the role of the novel empowering experiential learning through a cooking and fitness intervention activities will play on health literacy and metabolic outcomes, engagement in fitness and motivation, and stress levels will be evaluated.

Nutrition and mindful movement program activities will take place during the school day. Children will be given the opportunity understand the value of quality nutrition in the prevention com-morbidities of treatment and poor lifestyle choices. The intervention will consist of ten sessions. This includes pre- and post-assessments (weeks 1 and 10) and eight weekly 1-hour interactive culinary medicine education sessions. Children will be asked questions about their diet, feelings, physical activity. Height, weight, waist circumference, and grip strength will also be measured. This will take about one hour prior to beginning the education portion of our program. Each week, \\a nutrition lecture, a cooking demo and fitness activities will be completed over two-45 minutes sessions during PE class. These hands-on applied nutrition sessions include fundamental of nutrition, cooking skills, cooking skills, and activities. Experiential or hands-on applied learning, including culturally appropriate meal preparation and personalized nutrition and mindful movements, represents a potential tool to increase adolescent health literacy as well as empower adolescent to engage their families. Cooking as medicine helps people make the healthy behavior changes they are seeking because it allows hands-on teaching and learning in a fun interactive environment, without stigma. This strategy encompasses combination of thinking and doing skills that are applied during home food preparation, as well as conceptual and perceptual abilities on food handling, safety and storage, and other factors related to nutrition. The delivery of cooking as medicine programs serves as a way to improve and promote confidence, well-being, and enhance meal quality and preparation practices and offer a valuable platform to engage children and families via inclusive social activities, whilst positively impacting their dietary profiles and health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* speak and read English able to ambulate student at selected school

Exclusion Criteria:

* medical condition precluding participation
Shivering and Glucose Homeostasis

The purpose of this study is to investigate the effect of prolonged shivering thermogenesis on glucose homeostasis in overweight/obese humans.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Caucasian
* Healthy (as determined by dependent physician based on medical questionnaire)
* Man, or postmenopausal (defined as at least 1year post cessation of menses) woman
* Aged 40 - 75 years at the start of the study
* BMI 27 and 35 kg/m2
* Stable dietary habits (no weight loss or gain \>3kg in the past 3 months)

Exclusion Criteria:

* - Not meeting all inclusion criteria
* Medication use known to hamper subject's safety during study procedures
* Co-morbidities to which the intervention or program that may pose as a complicating factor
* Subjects diagnosed with cardiovascular diseases or cancer
* Fasting plasma glucose ≥ 7.0 mmol/l
* Haemoglobin \< 7.8 mmol/l for women, or \< 8.4 mmol/l for men
* Previously diagnosed with type 2 diabetes
* Abuse alcohol/drug abuse
* Subjects who do not want to be informed about unexpected medical findings during the screening/study or do not wish that their physician is informed.
* Engagement in structured exercise \> 2h per week
* Participation in another biomedical study within 1 month before the first study
* Smoking
* Cold-acclimated, such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study
EVALUATION OF THE CAPACITY OF A BIOMARKER BASED ON THE RAMAN ANALYSIS OF SYNOVIAL FLUID

Osteoarthritis (OA) is the most common joint disease in the world and induces major physical, psychological, societal and economic burdens.

The management of osteoarthritis is complex. Viscosupplementation by local injection in the arthritic knee is a validated therapy used after failure of conventional analgesic treatments and non-pharmacological modalities. The size effect of this treatment is modest between 0.3 and 0.6. We do not currently have any predictive criteria for the effectiveness of this treatment.

The procedure tested in this research is the characterization of synovial fluid (SF) by an in vitro Raman microspectroscopy technique.

The results obtained will make it possible to compare the effectiveness of visco-supplementation with hyaluronic acid from the Hyalgan© trade according to classic criteria in the literature.

The proposed study consists in analysing the synovial fluid (SF) of patients obtained in conventional care that do not require new medical or nursing procedures.

All care that patients will receive is routinely provided by physicians. There is no additional act of surveillance during the research. The follow-up medical visits are exactly the same as those offered to patients as part of their treatment, no additional visits are required.

During the orthopedic consultation for HA injection, the initial WOMAC score as well as the PGAP and PASS scores will be measured. SF, usually considered as medical waste, will be collected during an arthrocentesis prior to the intra-articular injection of hyaluronic acid, freezed at -80°C and then sended to the IVTV platform at the Ecole Centrale de Lyon for DDRS Raman spectroscopy (LabRam HR 800, Horiba Jobin Yvon, Villeneuve d'Asq). Studied SYNODIAG biomarkers are dried drops parameters (surface) and Raman ratios according to the FR3059781 patent.

At the 6-month follow-up visit, WOMAC, PGAP and PASS scores will be re-measured to determine the patient's responding/non-responding status.

Finally, the objective of the study is to verify if there are significant differences between the Raman ratios and dried drops parameters of SF patients responding and non-responding to viscosupplementation.

Eligibility Criteria:
Inclusion Criteria:

* If woman, not to be pregnant
* Have radiographically diagnosed osteoarthritis of the knee that meets OARSI criteria for gonarthrosis (Altman and Gold, 2007; Kellgren and Lawrence, 1957).
* Present a Kellgren-Lawrence radiographic score lower than 4
* Be treated with visco-supplementation after failure of conventional analgesic treatments and non-pharmacological modalities.

Exclusion Criteria:

* BMI greater than 28
* BMI lower than 15
* Kellgren-Lawrence score of 4
* Patients with no clinical symptoms of osteoarthritis
* Patients treated with intra-articular steroid injection during follow-up
* Patients who have had a synovectomy
* Patients with severe systemic disease or with rheumatoid arthritis or other intercurrent rheumatic disease
Kabat Training Program With Elastic Bands for Shoulder in Amateur Swimmers

It has been shown that 90% of swimmers experience shoulder pain at some point in their career. During the macrocycle, swimmers present significant alterations in the muscular balance between external and internal rotators of the shoulder: the IR assumes much prominence in strength levels and RE goes progressively weaker.

furthermore, all overhead athletes (such as swimmers) present a glenohumeral Internal Rotation Deficit and an increase in External Rotation.

The objective of this study is to propose an exercise with an elastic band aimed to strengthening the RE of the shoulder to analyze the effects on the muscular balance between IR and RE. In addition, the effect caused in the limitation of internal rotation is going to be studied


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Swimmers minimum 2 times per week

Exclusion Criteria:

* Acute infection
* Shoulder pathology
* Neer and Hawkins-Kennedy test positive
New Biomarkers for Invasive Fungal Infections in Paediatric Haemato-oncology

The availability of sensitive and specific fungal biomarkers could be a precious help to improve the management of patients suffering from fungal diseases, not only by allowing preemptive treatment, but also by offering objective elements to assess patient therapeutic response and prognosis.

The use of such biomarkers could also contribute to accurately evaluate novel antifungal drugs effectiveness and to serve as a valuable tool to guide decisions regarding ineffective treatments and dose selection in product development. Using two or three tests may increase the sensitivity to detect IFI.

The results of the serum assays will be correlated to the definition of 'proven' fungal infection as defined by the EORTC/MSG criteria published in 2008. Based upon results from adults' studies, the investigators estimate that galactomannan antigen or 1, 3 β-D glucan could reasonably have a 90% sensitivity (with a 95% CI between 73% and 98%) under the current design. As concern the aspergillus fumigatus PCR, sensitivity and specificity could be estimated between 63% to 100% and 87% to 96.7%, respectively.


Eligibility Criteria:
Inclusion Criteria:

1. Any febrile episode in :

   * either a neutropenic child suffering from acute lymphoblastic leukemia under induction chemotherapy or relapse, acute myeloblastic leukemia under chemotherapy (all cycles of chemotherapy included) or myelodysplasic syndrome
   * an allogenetic hematopoietic stem cell transplantation recipient child, from conditioning till 3 months or receiving aggressive immunosuppressive therapy for at least 1 months
2. Age of children will be from 3 months till 18 years
3. Informed consent from the parents and from children older than 12 years obtained

Exclusion Criteria:

1. Any previous history of fungal infection (proven, probable or possible) with prescription of secondary oral prophylaxis (voriconazole or posaconazole) under current use at the time of the study.
2. Any previous episode already enrolled (only one episode/patient).
Fundus Changes in the Microphthalmy Eyes

The goal is to describe the fundamental aspects of fundoscopic eye in patients with microphthalmia

Microphthalmos is a developmental ocular disorder defined as a small eyeball. The condition can be associated with abnormalities of anterior and posterior segments. The most common anterior characteristics include corneal opacities, angle-closure and a shallow anterior chamber and cataract. The main findings of posterior segment are uveal effusion, retinal folds, abnormalities of macular capillary vascularization, absence of foveal depression and peripheral retinoschisis. We performed on 3 patients with microphthalmos and their OCT features of posterior segment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of microphthalmia

Exclusion Criteria:

* Eyes larger than 18mm
Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia

OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia.

II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients.

PROTOCOL OUTLINE: This is a randomized study. One group of patients is treated with soy protein isolate for 12 weeks. The control group receives a placebo for 12 weeks.

Patients cross to the alternate group following a 4-week washout.

Eligibility Criteria:
* Hereditary hemorrhagic telangiectasia (HHT) with 2 of the following:
* First-degree relative with HHT
* History of recurrent epistaxis or gastrointestinal bleeding
* Three or more skin telangiectasia
* Migraine headache meeting International Headache Society criteria 3 or more times a month for more than 1 year
* No pattern of daily headaches
* No severe head trauma
* No onset of headaches after 50 years of age
* At least 1 month since migraine prophylaxis
* At least 1 month since any of the following medications: Beta blockers; Calcium channel blockers; Divalproex sodium; Tricyclic antidepressants; Selective serotonin re-uptake inhibitors
* Concurrent regular treatment for migraine and gastrointestinal hemorrhage allowed
* Creatinine no greater than 2.5 g/dL
* No allergy to soy
* No pregnant women
* No women with intent to become pregnant
Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk

Introduction- Primary prevention is the main strategy to control the global burden of cardiovascular disease. In clinical practice, food restriction represents a valuable preventive resource. However, low adhesion rates and diet abandonment are considered important obstacles in treatment. Considering the discovery of new markers and mechanisms that relate food restriction and to all other cardiovascular risk factors, it is possible and necessary to seek for efficient alternatives to increase adherence and effectiveness of the preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food restriction. The bariatric surgery have gained importance not only for its potential application in obesity treatment but also in the control of cardiovascular risk factors refractory to medical treatment. Among bariatric operations, there is a group called digestive adaptations III that has specific characteristics.This surgical intervention modifies intestinal tract by reducing gastric volume and performing an anastomosis between ileum and stomach, creating a bipartition in the gut. This structural modification promotes satiety and increased insulin sensitivity more intensely than other surgical strategies. The effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers related to the development of atherosclerosis are not yet established.

Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and laboratory parameters and cardiovascular risk factors.

Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal obesity will be included in the study. Of this group, half will be randomly selected to perform the Digestive Adaptations III surgery. All participants will undergo clinical and biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four months after surgery. On these occasions besides the lipid profile and glucose, we will determine incretin hormones, adipokines and assess the amount of epicardial fat.


Eligibility Criteria:
Inclusion Criteria:

* Men.
* Adults (raging from 18 to 65 years).
* Ability to understand the procedure, risks and alternatives.
* Patients with BMI \> 28 Kg/m2 and \< 35 Kg/m2 presenting type 2 diabetes diagnosed for more than two years and less than 10 years.
* Glycated hemoglobin\> 8% despite dietary and medical treatment that already includes the use of exogenous insulin
* Waist circumference \> 102 cm.

Exclusion Criteria:

* Chronic diseases not related to severe obesity.
* Pregnancy.
* Peptide C \<1.5 ng / mL or a positive anti-islet antibodies, anti-GAD or anti-ICA512.
* Previous cancer, unless deemed cured (after 5 years of treatment, at least)
* Acute infection or chronic relevant.
* Alcohol addiction.
* Tobacco use.
* Drug addiction, except those recovered for more than three years.
A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer

This study will evaluate the safety, tolerability, and pharmacokinetics of BLYG8824A and will make a preliminary assessment of the anti-tumor activity of BLYG8824A in patients with locally advanced or metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0 or 1
* Life expectancy of at least 12 weeks
* Histologically or cytologically documented invasive CRC: incurable, unresectable, locally advanced or metastatic CRC previously treated with multimodality therapy or mCRC
* Locally advanced or metastatic CRC that has relapsed or is refractory to established therapies
* Prior disease progression (or intolerance) following oxaliplatin, irinotecan, fluoropyrimidines, and anti-EGFR monoclonal antibodies
* An archival tissue specimen or fresh baseline biopsy (when archival is not available) is required for enrollment into the study
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Non-measurable evaluable disease is acceptable for dose-escalation.
* Adequate hematologic and end organ function
* Acute, clinically significant treatment-related toxicity from prior therapy resolved to Grade ≤ 1 prior to study entry

Expansion Cohort-Specific Inclusion Criteria

* MSS or MSI-L disease as determined by polymerase chain reaction (PCR) and/or IHC
* Measurable disease by RECIST v1.1 with at least one measurable target lesion in the expansion cohort
* Progression must have occurred during or after most recent treatment for locally advanced or metastatic colorectal cancer
* For patients enrolled in either a dedicated biopsy cohort or other expansion cohorts where biopsy is clinically feasible, willingness to consent to mandatory fresh pretreatment and on-treatment biopsies of safely accessible tumor lesions

Exclusion Criteria:

* Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of BLYG8824A
* Significant cardiopulmonary dysfunction
* Known clinically significant liver disease
* Positive serologic or PCR test results for acute or chronic HBV infection
* Acute or chronic HCV infection
* HIV seropositivity
* Poorly controlled Type 2 diabetes mellitus
* Current treatment with medications that are well known to prolong the QT interval
* Primary CNS malignancy, untreated CNS metastases, or active CNS metastases
* Leptomeningeal disease
* Spinal cord compression that has not been definitively treated with surgery and/or radiation
* History of autoimmune disease
* Prior allogeneic stem cell or solid organ transplantation