cyrilzakka/clinical-trials huggingface dataset:
Preliminary Evaluation Study of Therapeutic Education on Overweight People in Addition to a Hydrotherapeutic Cure

The goal of this study is to assess the effect of a therapeutic education program in addition of a hydrotherapeutic cure on obese patients.

The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a dietary follow-up, a physical activities program, working group.

The participants are people that come to the thermal baths in order to follow an hydrotherapeutic cure (of about 3 weeks). For the Action group, they also follow a course of therapeutic education where they are given advices on how they should eat and have a regular physical activity.

This therapeutic education in addition of the hydrotherapeutic cure should help them lose weight and not gain in again.

The participants are followed for 18 months (17 months after leaving the thermal baths).

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) over 27 kg/m² (or equal)
* Has a valid email address, has access to the internet and to a telephone line
* Has a domestic scale compatible with its weight
* Signed the consent form
* Susceptible to accept the obligations generated by the study
* Has a health insurance

Exclusion Criteria:

* Has a progressive illness at the time of the study (cancer, neurodegenerative disease...)
* Is pregnant
* Follows the hydro-therapeutic cure in order to cure rheumatism
* Trying to lose weight prior to a surgery
* Has a diagnosed eating disorder
* Has no physical activity due to a handicap or a serious osteoarthritis
* Has taken a weight-loss drug (Orlistat) in the past month or will likely do so in the future
* Is taking a Desmopressin-based drug
* Is unable to understand or follow the protocol
* Is deprived of liberty
* Is under judicial protection
Natalizumab (Tysabri) Re-Initiation of Dosing

The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.

Study 101-MS-322 (NCT00306592) was conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab in former clinical trial participants in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760) and included subjects in North America. In parallel with the conduct of that study, this study (101-MS-321 \[NCT00297232\]) was initiated for participants in Europe and the rest of the world. In addition, after 48 weeks, participants from 101-MS-322 (NCT00306592) could enter study 101-MS-321 (NCT 00297232), which was considered the Long-Term Treatment Period of 101-MS-322 (NCT00306592).

The primary purpose and primary outcome for both studies are identical; therefore, the combined long-term data from both studies are presented. (Combined Week 48 data from both studies are presented in the 101-MS-322 \[NCT00306592\] record.)

Eligibility Criteria:
Key Inclusion Criteria

* MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and a Dosing Suspension Safety Evaluation (neurological examination or a magnetic resonance imaging scan) or participated in the IMA 04001 (STARS) Study
* Subjects who are considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and glatiramer acetate) while being treated with natalizumab during the study.
* In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322 (NCT00306592) in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480).

Key Exclusion Criteria

* Considered by the Investigator to be immunocompromised
* History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
* History of any major disease or malignancy
* Discontinued natalizumab in a previous study due to allergic reaction

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy in the First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

The aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres across India.


Eligibility Criteria:
Inclusion Criteria:

* The study inclusion criteria is as per the label for patients with metastatic/recurrent SCCHN approved by India Health Authorities, i.e., "Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease."
* For each platinum-based chemotherapy, the related product labels approved by India Health Authorities will also be followed strictly in terms of patient eligibility.

Exclusion Criteria:

* Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria \[NCI-CTC\]) hypersensitivity reactions to Cetuximab are contraindicated for Cetuximab
Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy

The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting triglycerides (TG ≥250 mg/dL).

The secondary objectives are to estimate the effects of REGN4461 on a composite endpoint of changes in either HbA1c or fasting TG for all patients, estimate the effects of 3 dose levels of REGN4461 on glycemic parameters and fasting TG, to estimate the effects of REGN4461 on insulin sensitivity, to evaluate the safety and tolerability of REGN4461 and to evaluate the pharmacokinetics (PK) and immunogenicity of REGN4461.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol
* Presence of one or both of the following metabolic abnormalities at screening:

  1. HbA1c ≥ 7% OR
  2. Fasting TG ≥250 mg/dL
* Generally stable diet (based on patient's recall) and medication regimen (that optimizes treatment for their metabolic disease) for at least 3 months prior to the screening visit

Key Exclusion Criteria:

* Treatment with metreleptin within 1 month of the screening visit
* Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
* Treatment with oral glucocorticoids \>7.5 mg prednisone equivalents per day within 3 months prior to screening visit or plans to begin treatment with oral glucocorticoids \>7.5 mg prednisone equivalents per day during the study period
* History of Human Immunodeficiency Virus (HIV) or HIV seropositivity at screening visit
* Uncontrolled infection with hepatitis B or hepatitis C infection, or known active tuberculosis at screening
* Participation in any clinical research study evaluating an Investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit.
* Pregnant or breast-feeding women

NOTE: Other protocol defined inclusion/exclusion criteria apply.
The Activity School in Finnmark for Overweight Children

The purpose of this study is to evaluate the effectiveness of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional individual counseling in the pediatric outpatient clinic and the community. The two interventions are both hospital and community based.

Randomized study design with two parallel groups.Active intervention in two years, last follow-up after 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese.
* BMI \> IOTF (International Obesity TaskForce) cut-points 27,5. kg/ m2.

Exclusion Criteria:

* Diseases not compatible with normal physical activity.
* Disorders not compatible with group treatment.
Pilot Study of a Smartphone-Based Vaping Cessation Program

Prospective, open label, single center clinical study enrolling up to 100 participants to evaluate the effect of the Pivot vaping cessation program.

This is a prospective, open label, single center clinical study conducted with IRB approval enrolling up to 100 adult participants who report daily vaping. The study will be performed remotely on an ambulatory basis.

Participants will be asked to set up and use the "Pivot for Vape" program. The program includes an app, moderated online community, and SMS-based coaching with a tobacco treatment specialist. The study duration is 52 weeks, with the estimated active time using the program of up to 6 months and the time thereafter as follow-up. Participants will receive online questionnaires at intervals throughout the study.

Potential participants will complete an online screening form. Eligible participants will be called to confirm eligibility, discuss the study, and have their questions about the study answered. Interested eligible participants will complete the electronic informed consent form and baseline questionnaire prior to downloading the app on their smartphone.

The investigators aim to assess the performance of the "Pivot for Vape" program, with a focus on assessing use and engagement, changes in attitudes towards quitting vaping and changes in vaping behavior over the course of the 1-year study, as well as participant feedback on the set-up, design, use experience, and impact of the program.

Eligibility Criteria:
Inclusion Criteria:

* Current daily nicotine vape/e-cigarette user for at least the past 30 days
* Plans to quit vaping in the next 6 months
* Reports average VSPD ≥ 5
* Interested in working with a vape cessation coach via SMS text
* Resident of the United States
* Able to read and comprehend English
* Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 12 and above, or, Android 7.0 and above with operating system Android 7.0 and above)
* Has daily internet access on smartphone
* Comfortable downloading and using smartphone apps
* Willing to sign the Informed Consent Form (ICF)

Exclusion Criteria:

* Using other vaping cessation apps, coaching, classes, or quit programs at entry
* Currently using cigarettes
* If previous cigarette smoker, need to have quit smoking at least 3 months ago (self-report)
* Failure to provide contact or collateral information, and/or failure to verify email address
* Participation in a previous study sponsored by Pivot Health Technologies Inc. (formerly Carrot Inc.)
RSV Burden in Outpatient Settings

Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)

The study protocol is designed with three key components: 1. Build on existing PARI outpatient syndromic surveillance by adding laboratory multiplex testing of LRTI samples (RSV, Influenza, SARS-COV-2) 2. Follow all bronchiolitis through the PARI RWE database and document "patient journey" for 5 years after first medical visit 3. Review the electronic PARI data of three previous seasons in order to document the impact of LRTI attributable to RSV in children \< 2 years in France prior to enhanced surveillance

Eligibility Criteria:
Inclusion Criteria:

* children under 24 months of age (≤)
* One of the holders of parental authority signed the consent
* Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)
* First episode of bronchiolitis defined by
* Age ≤24 months
* At least one symptom from group A and one symptom from group B Group A (one or more)
* Fever \>38 °C
* Cough
* Otalgia
* Nasal congestion
* Rhinorrhea
* Coryza
* Dysphagia Group B (one or more)
* whistling
* Crackles
* Rales
* Decrease in respiratory noise
* Shortness of breath
* Dyspnea
* OR Acute purulent otitis media (Paradise Criteria) or otorrhea.
* OR Pneumonia defined by the presence of opacity of parenchymal condensation and/or pleural effusion on chest X-ray associated with fever

Exclusion Criteria:

* Age \>24 months
* Refusal by one of the parents
* Not affiliated to a social security system
Developing Fast Pediatric Imaging

This research study is evaluating the investigational software for magnetic resonance imaging (MRI) systems and techniques to process magnetic resonance (MR) images

The purpose of the study is to develop new technologies for MRI systems. The new technologies should improve MRI capabilities in terms of how sensitive, specific, and efficient they are. The overall goal is to get better measurements of the brain tumor tissue(s).

In this research study, the investigators want to learn more about investigational software and about techniques to process MR images. The testing of investigational software will allow the investigators to improve the image quality. As part of the testing process, the investigators will collect more MR images of the brain, and improve current image reconstruction methods. This will allow a more precise analysis of MR images and potentially better assessment of the brain tumor tissue volume.

Eligibility Criteria:
Inclusion Criteria:

* Infants, children and adults who have been diagnosed with Low Grade Glioma
* Healthy volunteers - Children from age 0 to adults with no upper age limit or;
* Diagnosed with LGG and being treated at DFCI;

Exclusion Criteria:

* Electrical implants such as cardiac pacemakers or perfusion pumps;
* Ferromagnetic implants such as aneurysm clips, surgical clips, prosthesis, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants;
* Ferromagnetic objects such as jewelry or metal clips;
* Women of childbearing age who are seeking to become pregnant, who are breastfeeding, or who suspect they may be pregnant;
* Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions;
* Any greater than normal potential for cardiac arrest
Nasal Anatomical and Pathological Variants in Patients With Antrochoanal Polyps

The goal of this observational study is to learn about anatomical and pathological variants in patients with antrochoanal polyps trying to find a key to its pathogenesis Participants will have nasal endoscopic examination and CT nose and paranasal sinuses.

we will compare patients with antrochoanal polyps and other patients with unilateral sinonasal disease regarding anatomical and pathological variants.

This study was conducted at Otolaryngology department, Minia University Hospital, Minia, Egypt. The study was approved by the Institutional Review Board at Minia University.

The study participants were recruited from patients complaining from unilateral sinonasal disease attending outpatient clinic.

we selected 40 patients with ACPs who had the following inclusion criteria: 1-radiologically diagnosed based on CT nose and PNS. 2-histopathologically diagnosed as ACP. The radiological diagnosis is based on seeing low attenuated soft tissue mass filling the maxillary antrum and extending through the middle meatus into the nasal cavity and directs towards the post nasal opening. We excluded: 1- patients with history of maxillofacial trauma. 2- patients who had previous nasal surgery.

To be more objective, a control group of 40 patients who had unilateral sinonasal disease other than ACP was formed.

We assessed multislice computed tomography (CT) nose and paranasal sinus images by Toshiba aquilion CT scanner. Axial and coronal 250mm cuts were obtained.

Both study and control groups were compared regarding anatomical and pathological variations in the nose. These variants include: deviated nasal septum, concha bullosa, paradoxical middle turbinate and uncinate process insertion (to lamina papyrecea or roof of ethmoid or middle turbinate). We also compare between them according to presence of retention cyst in CT in contralateral side In the cases with deviated nasal septum, the septal deviation was seen if it is towards the side of the lesion or towards the opposite side according to its convexity.

We also evaluate the sclerosis on thickening of the bony wall of the para nasal sinus as an indication of chronic inflammation.

SPSS 24.0 program was used for statistical analysis. Averages and standard deviations were calculated. The Mann-Whitney and Chi square tests were used for comparisons between the groups. The Pearson correlation tests was used to evaluate correlations. Statistical significance was set at ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

1. radiologically diagnosed based on CT nose and PNS.
2. histopathologically diagnosed as ACP.

Exclusion Criteria:

1. patients with history of maxillofacial trauma.
2. patients who had previous nasal surgery.
Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program

The aim of this study is to determine if therapeutic exercise before anticancer treatment will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise performed during anticancer treatment.

The positive relationship between physical exercise and cancer is widely justified in the literature, but an emerging research line warns of its capacity to improve the effectiveness and reduce the toxicity of cancer treatment (responsible for the appearance of side effects and comorbidities), that overload the health care system. To date, there is a lack of knowledge in different subjects: the possibility of implementing individualized exercise programs in clinical environment to mitigate the side effects of cancer treatment; the best moment in natural history of the disease to perform therapeutic exercise; and a tailored dose of exercise that maximizes its benefits.

In this context, the present study will evaluate the effects of a therapeutic exercise program conducted previously at the beginning of the cancer treatment, in the treatments' toxicity against the same program conducted during cancer treatments in women with breast cancer, and its positive effects on both clinical and biological variables and their possible impact on disease-free survival.

This study will be conducted in 3 phases with 110 participants in total: phase 1: a pilot study be carried out to check the feasibility of the proposed physical exercise program; phase 2: to test the effectiveness of the program ATOPE performed prior to surgical medical treatment against the same made during treatment, with a randomized controlled clinical trial; and phase 3: in which it will be integrated into the health service and a larger project will be requested at the international level.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Breast cancer diagnosis I-III stage
* On the waiting list to anticancer medical treatment (at least surgery, chemotherapy and radiotherapy.
* If they meet other criteria which predisposes to higher toxicity.
* Have signed informed consent.
* Have medical clearance for participation.

Exclusion Criteria:

* Patient underwent previous cancer treatments.
* Patients were previously diagnosed with cancer.
* Pregnant patients.
* Patients performing other type of therapeutic exercise at diagnosis time with an intake \>or = to 150 moderate-intensity or 75 min of vigorous-intensity a day.
* Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis \>70%, metastasis etc.).
Healthy Early Life Moments in Singapore

This study aims to assess whether an integrated continuum of care from the preconception period, across maternity until the first 18 months of life, can promote maternal metabolic and mental health, as well as offspring health, among overweight and obese women.

Maternal Child Health (MCH) in Singapore is currently entering a new phase to address the twin challenges; a burgeoning (i) Metabolic and (ii) Mental Health Challenge for Singapore which have shown to have adverse effects on childbearing and child outcomes. To tackle these challenges, we are establishing a new Model-of-Care (MOC) with a life-course approach at KK Women's and Children's Hospital (KKH) through the Healthy Early Life Moments in Singapore (HELMS) cohort. Over the course of five years, HELMS will enroll 500 overweight or obese women aged 21-40 years planning for pregnancy, with an estimated 170 completing their pregnancies where they will be followed for another 18 months as a mother-child dyad.

HELMS leverages on building a healthy mental model of life-course events through preconception to postpartum life. Components of intervention will focus on preconception-pregnancy-postpartum care and lifestyle guidance on diet, physical activity, emotion and sleep, complemented by health nudges to promote sustainable change. Various questionnaires and testing will be carried out at relevant time points. Biosamples including blood, cord blood and stool will be collected.

Through the application of HELMS, there is potential to improve metabolic and mental health, break vicious transgenerational cycles of obesity transmission and promote virtuous life cycles of health in the population.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 21-40 years
2. BMI 25-40 kg/m2
3. Intention to reside in Singapore for the next 4 years
4. Chinese, Malay, Indian or any combination of these 3 ethnic groups
5. Planning to conceive within 1 year
6. Able to understand English
7. Able to provide written, informed consent

Exclusion Criteria:

1. Currently pregnant
2. Known type 1 or type 2 diabetes
3. On any anticonvulsant medication in the past 1 month
4. On any oral steroid in the past 1 month (e.g. Prednisolone, Prednisone, Deltasone, Prelone, Methyl Prednisolone, Medrol, Hydrocortisone, Cortef, Dexamethasone, Decadron)
5. On any oral, implanted contraception or intrauterine contraceptive device (IUCD) in situ in the past 1 month
6. On any fertility medication (e.g. hormones injection, IVF treatments) other than Clomiphene/ Letrozole in the past 1 month
7. On HIV or Hepatitis B or C medication in the past 1 month.