cyrilzakka/clinical-trials huggingface dataset:
Medico-economic Evaluation Comparing the Impact of the New Fixed-dose Nivolumab Regimen With the Old mg/kg Regimen in the Management of Patients With Metastatic Cancer

Nivolumab is a selective monoclonal antibody that binds to the Programmed cell Death 1 (PD-1) receptor and causes reduced tumor growth. It is currently approved in France in many indications. The firsts therapeutics indications validated by the French health authorities from 2015 - metastatic melanoma2, squamous and non-squamous NSCLC, Kidney cells carcinoma - were based on clinical trials demonstrating a clinical advantage over standard nivolumab treatment at a dose of 3mg/kg every two weeks.

By comparing the results predicted by simulation based on a pharmacokinetic model with those obtained in clinical trials, the manufacturer of nivolumab concluded that a fixed dose of 240 mg was equivalent to that calculated based on the weight of the patients, and the European and then French health authorities have validated this change in clinical practice The objective of the IMEPOCA study is to assess in real life the economic and clinical impact of the dose modification of nivolumab that occurred in December 2018 in France.

In order to assess the economic efficiency of the change in dose strategy at the national level, 2 cohorts of patients from the National Health Data System (SNDS), treated for metastatic cancer and followed up over 1 year will be compared: one having benefited from the weight-dependent dosage and the other having benefited from the fixed dosage


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic melanoma, non-small cell lung cancer (NSCLC) and renal cell carcinoma treated with nivolumab monotherapy
* Patients whose nivolumab treatment was initiated between 2015 and 2020
* Patients with health insurance

Exclusion Criteria:

* Patients whose nivolumab treatment initiated in 2017 in mg/kg has progressed to a fixed dose in the 1st year of treatment
* Patients treated with nivolumab in the adjuvant setting for melanoma with lymph node involvement or metastatic disease and who have undergone complete resection (Approval in 2018 for this indication)
* Patients whose nivolumab treatment has been initiated in 2018
KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice

Approximately, 20 rural primary care practices to participate in a delayed intervention-controlled trial.

Phase I: Formal and structured work flow evaluations to better identify specific gaps in processes of care while assessing what on-going training is needed for adoption of high-quality cancer survivorship care in rural practice. These will be incorporated into the ECHO sessions (Aim 1).

Phase II: Conduct and test the effectiveness of the novel KanSurvive-ECHO intervention (Aim 2) and finally identify barriers and facilitators to implementation of KanSurvive-ECHO (Aim 3).

While evidence-based practice (EBP) guidelines exist for cancer survivorship care, implementation in rural practices has fallen short. Approximately 72.5% of Kansas cancer survivors who have completed their cancer treatment receive a majority of their health care from Primary Care Providers, yet these providers describe a lack of basic awareness of risk-based surveillance, effects of cancer treatment and their management, as well as inadequate resources, and growing administrative demands as reasons for not working to improve survivorship care. These factors may also prevent shared care management of cancer survivors between primary care and rural oncology care providers. There is a pressing need to understand primary care practice capacity to implement guideline informed management and follow-up for cancer survivors in the acute and extended phases of care.

Specific Aim 1. Formally assess gaps in processes of care and additional training needed to result in actual adoption of high-quality care for acute and chronic survivors of breast, colorectal, lung, and prostate cancer in 20 rural primary care practices. Utilize this formative information to further refine the KanSurvive-ECHO.

Specific Aim 2. Evaluate the effectiveness of KanSurvive-ECHO for enhancing evidence-based survivorship care for rural breast, colorectal, lung, and prostate cancer survivors.

Hypothesis: Compared to delayed intervention control, rural primary care practices randomized to KanSurvive-ECHO will demonstrate greater concordance with evidence-based survivorship care guidelines as measured by a composition score determined by change in EHR documentation consistent with guideline concordant care.

Specific Aim 3: Utilizing the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework describe key facilitators and barriers to implementation of KanSurvive-ECHO including innovation, recipients, context, and facilitation.

This novel project will provide a model for development of a community of practice using practice facilitation and Project ECHO to improve the management and follow-up of cancer survivors in the acute and extended phases of cancer survivorship.

Eligibility Criteria:
Inclusion Criteria:

* Must be a primary care practice caring for rural cancer survivors
* Must be willing to participate in four ECHO sessions
* Must be capable and willing to complete pre- and post- data collection
The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

Excessive gestational weight gain is a major public health problem. Traditional face-to-face intervention programs has been shown to be succesful in order to promote healthier weight gains, however, they are time-consuming and expensive. The objectives of this study are to assess whether a 6-month smartphone application can promote healthy gestational weight gain, dietary habits and physical activity in pregnant women.

Excessive gestational weight gain (GWG) increases risks for pregnancy complications, postpartum weight retention and offspring obesity. Traditional intervention programs are time and cost intensive. Mobile technology (mHealth) has been successful for weight loss and behavior changes; however, their use in pregnancy need to be further examined. This study aims to evaluate the impact of a smartphone application (app) intervention on GWG, diet, physical activity and glucose homeostasis.

HealthyMoms is a randomized controlled trial recruiting women at the first maternity clinic visit (week 6-10) in the Linköping area, Sweden. Women will be randomized to the control or intervention group (n=150 per group). All women will receive standard care. The intervention group will also receive the HealthyMoms smartphone app promoting healthy eating, activity and GWG during 6 months. Pregnancy outcomes are GWG (primary), food intake (web-based questionnaire), fat mass (BodPod), glucose homeostasis, activity (accelerometer) in week 37. Maternal and infant body fatness will be assessed one week post partum.

Eligibility Criteria:
Inclusion Criteria:

* a single pregnancy
* aged 18 years or above
* be able to speak and read Swedish sufficiently well.

Exclusion Criteria:

* previous diagnosed eating disorder
* pre-pregnancy diabetes or medical conditions or pharmacological treatments prior to pregnancy that may affect body weight
Sexual Dysfunction After Renal Transplantation

A questionnaire will be send to kidney transplant recipients to investigate characteristics of them and their sexual function, all participants in the survey are anonymous and voluntary, then analyse these characteristics.


Eligibility Criteria:
Inclusion Criteria:

* patients who have undergone kidney transplantation for more than six months

Exclusion Criteria:

* having no sexual partner, being under 18 or over 70 years of age, exhibiting abnormal mental behavior, having poor understanding and communication ability, having low intelligence, or having a congenital sexual disorder
Oral Processing Behavior of Gluten-free and Gluten-containing Breads

To attend the increasing demand for gluten-free products, new gluten-free formulations emerged in the market containing alternative ingredients to mimic the protein functionality of wheat. The replacement of wheat, however, has consequences in the sensorial properties of gluten-free products, which can compromise the acceptability of products. This study aims to investigate the oral processing behaviour of gluten-free and gluten-containing breads. Two commercial products, one gluten-free and one gluten-containing bread will be tested either without spread or with butter or mayonnaise. Spreads will be added to the breads to resemble a sandwich consumption which is a more realistic approach than that previously used. The investigators hypothesize that changes in the structure of gluten-free breads resulting from the absence of a strong gluten network can have a prominent impact on the way gluten-free bread is orally processed. The investigators also hypothesize that the addition of spreads will facilitate the oral processing of bread due to an increase in moisture content and lubrication.

The number of chews, number of swallows and eating duration will be determined through video recording of 20 subjects. The texture attributes predominantly at the beginning of mastication and at the swallowing point will be accessed using a check-all-that-apply test. Additionally, the amount of saliva incorporated during chewing will be determined from the spat out food bolus.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-59 years old
* Have good general oral health (self-reported)
* Have normal smell and taste functions (self-reported)
* Have a normal body mass index (BMI 18.5-24.9 kg/m2) (based on self-reported weight and height)
* Have no dental braces or a piercing in or around the mouth (except removable piercings)
* Have given written informed consent

Exclusion Criteria:

* Have any food allergy or intolerance for gluten
* Have mastication and/or swallowing problems caused by neurological problems, i.e. stroke, Parkinson, Alzheimer, Huntington
* Being pregnant or lactating (self-reported)
* Use medication that may affect the function of taste, smell, mastication and salivation
Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy

Statement of the problem :

Which is more effective for treatment of drooling in children with spastic cerebral palsy; kinesio taping or oromotor training?

Null Hypothesis:

There will be no difference between the effectiveness of kinesio taping and oromotor training on drooling in children with spastic cp.

Subjects:

The Study targets the children with spastic cerebral palsy from both sexes , sample size estimation will be carried out to determine the recruited number of children ,Children participating in this study will be selected randomly from Cairo pediatric physical therapy centers to participate in this study.

Study Design:

A comparative experimental design (Prospective pre-test post-test design with 2 months follow-up evaluation) .

Children will be assessed by measuring the drooling before and after two months of receiving intervention.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of spastic cerebral palsy with drooling problem.
2. The age of the selected children will range from 4to 8 years old.
3. Severe degree of drooling according to Drooling Severity and Frequency Scale.
4. Child with good head control

Exclusion Criteria:

1. Congenital problems of mouth and soft palate such as cleft lip and palate, jaw anomalies and salivary gland pathologies.
2. Epilepsy.
3. Child receiving drugs that could affect saliva production or other treatments to control drooling just before or during the study.
4. Allergic reactions to the kinesio tape.
Effects of Fasting Mimetic Diet on Nephropatic Patients

Fasting mimetic diet (FMD) showed positive effects on cardiovascular risks. Purpose of the trial is to evaluate FMD effects on patients affected by chronic kidney disease (CKD), through the stimulation of kidney stem cells and improving cardiovascular and metabolic status.

From April 2018, the investigators enrolled 13 patients (7 male) with an history of primary glomerulonephritis (GMN) and an eGFR between 60 ml/min and 30 ml/min. Exclusion criteria are: age \<18 y.o., age\> 65 y.o., secondary GMN, severe heart failure (NYHA IV),ongoing infectious diseases, ongoing neoplasia, hepatic diseases, COPD, inflammatory bowel disease, history of stroke, history of acute coronary disease less than 3 months, pregnancy, refuse informed consent.


Eligibility Criteria:
Inclusion Criteria:

* History of primary glomerulonephritis
* eGFR between 60 ml/min and 30 ml/min
* age between 18-65 years old

Exclusion Criteria:

* secondary GMN
* severe heart failure (NYHA IV)
* ongoing infectious diseases
* ongoing neoplasia,
* hepatic diseases
* COPD,
* inflammatory bowel disease
* history of stroke
* history of acute coronary disease less than 3 months
* pregnancy
* refuse informed consent.
Tailored Mediterranean Lifestyle Education in Participants With Subjective Cognitive Impairment

It is estimated that 30% of Alzheimer's disease cases globally are associated with changeable risk factors, such as diet and physical activity. In particular, a Mediterranean diet (MD) has been associated with reduced risk of cognitive decline and improved brain function.

The investigators developed educational resources on the Mediterranean diet and lifestyle (THINK-MED) in accordance with the Medical Research Council guidance for developing and evaluating complex interventions, based on a systematic literature review and informed by qualitative work with patients with mild memory problems.The feedback gathered informed refinements and tailoring of the resource and overall MD intervention.

This study aims to evaluate feasibility of the "THINK-MED" Mediterranean lifestyle educational intervention to encourage dietary behaviour change among community-dwelling people with subjective cognitive impairment.

This pilot RCT aims to evaluate the feasibility of a theory-based, tailored Mediterranean lifestyle education intervention (THINK-MED) to encourage behaviour change among participants who have subjective cognitive impairment.

This study will be a 6 month randomised controlled trial (RCT) with a total of 30 participants who will be randomised to 1 of 3 groups:

1. Group 1 will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource on one occasion at baseline (n=10)
2. Group 2 will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource at monthly intervals for 5 months, with an initial face-to-face visit from the research dietitian (month 1) and accompanied by telephone feedback (month 2-5) (n=10)
3. Group 3 is a control group. Participants in this group will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource after completing the 6 month study (n=10)

Eligibility Criteria:
Inclusion Criteria:

* Have subjective cognitive impairment - Montreal Cognitive Assessment (MoCA) score ≥ 26/30
* Mediterranean diet score (MDS) ≤ 4 (Estruch et al. 2006)
* Willing to make changes to their diet

Exclusion Criteria:

* Diagnosis of dementia
* MoCA score of ≤ 25/30
* Individuals with a visual or English language impairment
* Psychiatric problems e.g. depression
* Significant medical comorbidity
* Body Mass Index (BMI) ≤ 19 and ≥ 40 kg/m2
* Excessive alcohol consumption
* Dietary restrictions/allergies that would substantially limit ability to complete study requirements
* Inability to provide informed consent
* History of, or comorbid condition which may alter performance on cognitive tests e.g. stroke, head injury, Parkinson's disease, learning disability
Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.

Aim of the study is the efficiency assessment of porous Metronidazole loaded matrix based on gelatin/hydroxyethylcellulose blend in treatment of deep periodontal pockets resulting from severe chronic periodontitis. The matrix was invented and produced in Department of Drug Form Technology, Wroclaw Medical University.

The porous metronidazole (MTZ) loaded matrix was fabricated by the freeze-drying technique. The morphology, mechanical properties, in vitro degradation, MTZ release from dried sponge were evaluated and also the clinical trials were performed.

Patients suffering from chronic periodontitis are examined. To evaluate oral hygiene API (Approximal Plaque Index) and the gum inflammation BOP (Bleeding on Probing) and PBI (Papilla Bleeding Index) indices are used. The clinical examination is performed 3 times. On the first visit the output indicators are defined. The subgingival scaling is performed and Metronidazol on porous matrix is applied to the selected periodontal pockets. 2 control tests of periodontal indices are carried out after one week and one month from the application.

In the control group after scaling/root planing procedure, there is no application of metronidazole.


Eligibility Criteria:
Inclusion Criteria:

* non-smokers
* suffering from chronic periodontitis

Exclusion Criteria:

* any antibiotics taken systematically or locally in the preceding six months
Study on the Use of Inhaled NO (iNO)

This is a prospective, observational, multicenter study conducted during 1 year in adult and paediatric intensive care units equipped with the EZ-KINOX™ system.

A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was planned to be included.

The study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management.

This study is intended to describe daily practice and therefore, there is not a standardized protocol but only patient-based and site-based questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Newborn \> or = to 34 weeks gestational age suffering from hypoxic respiratory failure with pulmonary hypertension (France only) or patient presenting post-operative pulmonary hypertension associated with cardiac surgery (France and Belgium) · Patient treated with iNO delivered with EZ-KINOX™

Exclusion Criteria:

* Newborn dependent on a right-to-left shunt or with a "malignant" left-right arterial canal
* Newborn with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents

The main objective of this study is to test an intervention to increase the physical activity of medical residents, an employee population with little time for exercise. Specifically, the aims of this study are:

1. To determine if providing medical residents with an activity device that measures steps, distance, and calories burned and tracks this information over time on a website increases residents' physical activity levels as measured by number of steps per day compared to a control group using a blinded activity device (no feedback).
2. To determine if an unblinded team competition using the activity device directly following the randomized phase increases residents' activity level compared to baseline.
3. To determine if activity level is associated with change in weight during the residency year.
4. To determine if the average hours of sleep per week is associated with changes in weight and with activity level.


Eligibility Criteria:
Inclusion Criteria:

* Massachusetts General Hospital medicine resident

Exclusion Criteria:

* none
ADAPT Study: Assessing Diet, Appetite and Physiology Throughout Weight Loss Study)

Behavioral weight loss programs for obesity can result in weight loss and health benefits. However, behavioral weight loss often stops despite efforts to continue losing weight, this can be called an involuntarily weight loss plateau. This study investigates changes in metabolism and/or the brain that contribute to the occurrence of an involuntary weight loss plateau.

Participants will be asked to enroll for 18-months. Each participant will complete 3 in-person study visits, then participate an a 6-month weight loss program delivered remotely. Some participants may be invited to complete 3 additional in-person visits. Study Visit activities include questionnaires, blood draws, brain MRIs, body measurement and dual energy x-ray absorptiometry (DXA) scan for body composition measurement, a breathing test, and biopsies of muscle and fat tissue. Each participant will be provided a fitness tracker and body weight scale to use throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30.0 - 50.0 kg/m2
* Able to attend study intervention classes and study visits/assessments
* Independently living with access to food preparation facilities

Exclusion Criteria:

* Current smoker or regular use of nicotine containing products and/or cannabis
* Heavy alcohol use (≥2 drinks/d for females, ≥3 drinks/d for males) or drug use
* Known cognitive impairments or h/o stroke
* Type 2 diabetes (known diagnosis or by screening A1c (≥6.5%))
* Medical conditions (chronic diseases, cancer, MS) or labs limiting ability to participate
* Females: currently pregnant (or 6-months postpartum of full-term pregnancy) and/or current breastfeeding
* Use of medications with significant effects on appetite (e.g., weight loss medications, atypical antipsychotics, stimulants) and/or chronic use of anticoagulants
* History of bariatric surgery
* History of eating disorder
* Current participation in a formal weight loss program
* Prior or current participation in a research study involving weight loss
* Weight-reduced by \>10% within past year
* Weight \> 330 pounds (MRI limit)
* Allergy or intolerance to or unwillingness to consume study foods provided at visit
* MRI contraindication (e.g., implanted metal, claustrophobia)
* Do not have a phone compatible with activity tracker or access to videoconferencing platform that will be used for the dietary intervention or other appropriate technology needed to complete study procedures
* Any condition(s) found by the study team and confirmed with the PI(s) that make it unsafe to participate
Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer

Investigating the safety and the activity of Rapamycin, administered before and during preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose escalation study will be performed in three steps (2, 4 and 6 mg). Patients entered in phase II will follow the same tolerable treatment regimen as patients in phase I study.

Treatment regimen Phase I A daily dose of Rapamycin will be taken during 13 days. At step 1 a dose of 2 mg will be given once a day; at step 2 a dose of 4 mg will be given once a day; at step 3 a dose of 6 mg will be given once a day.

Preoperative radiotherapy (5x 5 Gy) will be administered at day 8-12, followed by TME-surgery at day 15.

Phase II A daily dose of 6 mg Rapamycin will be taken for 14 days (unless the optimal dose found in the phase I study is lower).

Preoperative radiotherapy (5x 5 Gy) will be administered at day 9-15, followed by TME-surgery 7-8 weeks post RT.

Sample size Phase I dose-escalation study Minimum 3 eligible patients per step, maximum 6 eligible patients per step. Phase II A total of 47 patients will be entered in this part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven rectum cancer
* UICC TNM I-III
* WHO performance status 0-2
* Less than 10% weight loss the last 6 months
* No recent (\< 3 months) severe cardiac disease
* Normal serum bilirubin and serum creatinin

Exclusion Criteria:

* Concurrent chemotherapy with radiation
* History of prior pelvis radiotherapy
* Recent (\<3 months) myocardial infarction
* Uncontrolled infectious disease
* Concurrent medication known as inhibitors of CYP3A4 susceptible to increase Rapamycin blood concentrations