cyrilzakka/clinical-trials huggingface dataset:
Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies

This phase II trial studies how well a web-based program called Project Prepare works in helping patients with head and neck cancer adhere to swallowing and trismus exercises and coping strategies. Head and neck cancer patients who receive radiation therapy are at risk for permanent swallowing disorders and other side effects. Because of these potential problems, swallowing exercises and coping strategies are important parts of recovery. A web-based program designed to increase adherence to preventive exercises may help patients with head and neck cancer ameliorate the long-term effects of radiation therapy.

PRIMARY OBJECTIVE:

I. To determine the impact of a web-based adherence program (PREPARE) on self-reported swallowing function in head and neck cancer patients during radiation.

SECONDARY OBJECTIVE:

I. To determine community participant adherence to targeted swallowing and trismus exercises delivered by the PREPARE website video demonstrations.

EXPLORATORY OBJECTIVE:

I. To promote the long-term dissemination of the Dysphagia Prevention program through measurement of patient satisfaction and engagement metrics, training and continual feedback between the MD Anderson Cancer Center (MDACC) research site and community collaborative research sites.

OUTLINE:

Patients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care.

After completion of study, patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Receiving radiation treatment with curative intent for throat cancer
* Can read and speak English or Spanish well enough to answer our questionnaires and understand our website content.
Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Chronic Disease

This multi-national program applies a breakthrough approach to childhood obesity called, Brain-to-Society (BtS) Diagnostic Approach. In Montreal, Canada and Palwal, India, the investigators will recruit two cohorts of 612 children (6 to 12 years; 306 boy/306 girls) where Whole-of-Society (WoS) transformations are taking place (industrialized societal context with peaking childhood obesity and where a broad governmental plan to promote healthy lifestyle has been adopted -Canada; developing societal context with increasing childhood obesity if replication of past pathways that have lead to double burden; India) are taking place along with World Health Assembly (WHA) resolution A63-12 for marketing of food to children. Individual-level BtS Diagnostic will examine the degree to which individual differences in genetics and biology and differences in the environmental exposures modulate the behavioral, body weight/fatness and nutritional risk over time in the context of WoS transformations. Societal-level BtS Diagnostic shall examine the influence of decisions in policy, investment, business and innovation made by different stakeholders (government, private sector, civil society in health and non-health society systems including agriculture, business and media practices) on the community.


Eligibility Criteria:
Inclusion Criteria:

* Sample population that are exposed to multi-level Whole-of-Society transformation (i.e., Quebec Governmental Action Plan (PAG) and World Health Assembly (WHA) resolution for Quebec sample; Intense Urbanization and Industrialization (IUI) and WHA resolution in India).

Exclusion Criteria:

* first cousin relations were excluded from the sample population.
Study of ESR1 Mutations in Metastatic Breast Cancer

The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.

Breast cancer is the most common cancer in woman. Aromatase inhibitors have demonstrated a real efficacy however a resistance to treatment exists.

ESR1 mutations appear like involved in the mechanism of resistance to aromatase inhibitors treatment.

The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.

The significance of the Digital PCR technique will be determined first in plasma issued from healthy volunteers.

At the initiation of aromatase inhibitors treatment patient with metastatic breast cancer will be included in the study. During their follow-up visit every 3 months), their status towards their disease will be collected and a plasma will be collected too.

When the patient progress clinically or radiologically the plasma concomitant to this progression will be analysed by Digital PCR to detect ESR1 mutations.

The patient will be followed during 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Woman aged superior to 18 years old
* Inform consent signed
* Metastatic breast cancer or loco-regionnaly advanced breast cancer
* Inoperable
* With an indication to treat with aromatase inhibitor
* Treatment with aromatase inhibitors innitiated at the inclusion or at least 6 months before inclusion with a stable disease
* Without precedent treatment or with treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment and with a time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution
* Treatment by aromatase inhibitors alone or in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus)

Exclusion Criteria:

* No inform consent signed
* Patient under guardianship, curatorship
* Psychosocial disorder
* No affiliated or beneficiary of a social benefit system
RCT Comparing the DEXA Results of the HA-Omnifit Versus the Symax Uncemented Hip Stem

Thr purpose of this study is to compare the clinical and radiological results, as well as the femur bone density measurements of two uncemented total hip prostheses during 5 years of follow up.

It is of great importance for the function of uncemented total hip arthroplasty that the anchorage of the prosthesis in the bone of the femur is sufficient. This is of great importance in the prevention of stress shielding of the bone and to insure tranfer of forces from the prosthesis to the femur.

The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical stability.

In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used and long term evaluated uncemented hip prosthesis) During the fist two years of follow up DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient fuction score and radiological evaluation measurements are done during 5 years of follow up.

Our primary objective is: comparison of the short term bone remodelling surrounding the Symax hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem measured by bone densitometry, clinical and radiographic evaluation.

Eligibility Criteria:
Inclusion Criteria:Male or non pregnant female patients \>18 years

* Patient with degenerative or traumatic changes to hip requiring hip replacement
* Patient with BMI\<35
* Patient signed informed consent

Exclusion Criteria:

* chronic anti-inflammatory medication use\> 3 months
* revision surgery to the affected femur
* Cancer therapy including immunosuppression, chemotherapy and radiation
* Pathological fractures, delayed ossification or non-union is likely to occur
Prevention of Alcohol Related Incidents in the US Air Force

Alcohol misuse poses significant public health concerns in the U.S. military. A Brief Alcohol Intervention (BAI) have been shown to reduce alcohol related incidents among Airmen undergoing training. The current study sought to examine whether a booster BAI administered at the end of an Airmen's training reduced alcohol related incidents out to a one-year follow-up. Participants were 26,231 US Air Force Technical Trainees recruited between March 2016 and July 2018. Participants were cluster randomized by cohort to two conditions: BAI + BAI Booster or BAI + Bystander Intervention. The primary analysis was a comparison of the interventions' efficacies in preventing Article 15 alcohol related incidents at a one-year follow-up, conducted using a generalized estimating equations logistic regression model controlling for covariates.


Eligibility Criteria:
Participants were Airmen undergoing Technical Training at five military bases (Lackland Air Force Base, Keesler Air Force Base, Sheppard Air Force Base, Goodfellow Air Force Base and Fort Sam Houston) in Texas and Mississippi from March 2016 through July 2018. Eligibility criteria included being at least 18 years of age and understanding the consent process in English.
Proteomics in Multiple Trauma to Identify Organ Failure

To analyse differences in protein expression in multiple trauma patients for identification of potential biomarkers to predict organ dysfunction.

The aim of the present study in humans is to analyse differences in protein expression after multiple trauma in patients for identification of potential biomarkers to predict organ dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* multiple trauma patients
* ISS \>16

Exclusion Criteria:

* children
* ISS \<16
An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during the 6 months of induction treatment and for up to 3 years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CD20+ diffuse large B-cell lymphoma or follicular lymphoma
* Treatment with MabThera/Rituxan as per locally approved China package insert
* Documented patient with medical records

Exclusion Criteria:

* Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma
Obstetric Outcomes in Women With PCOS

The aim of the study is to investigate body composition in newborn children of women with PCOS and controls and to investigate adverse obstetric outcomes in pregnant women with PCOS.

A prospective cohort study investigating 208 women with PCOS giving birth after singleton pregnancies at Odense Univesity Hospital during 2003-2011 and a date-of-childbirth matched control group of 1040 women. Anthropometric data from children is recorded as well as data on maternal parity, age, pre-gestational BMI, and adverse obstetric outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PCOS and giving birth during 2003-2011

Exclusion Criteria:

* Multiple pregnancy
Electronic Patient Reported Symptom Assessment

The purpose of this study is to assess whether using computerized screening questions can improve how well we manage symptoms related to cancer and cancer treatments. Advance care planning is a process in which teams of experts assist in with treatment plans, managing pain and other symptoms, emotional issues, and end of life issues. With advances in technology, it is now possible to get the patient's feedback directly and more often. It is thought that repeated questionnaires completed by the patient will provide a better and more accurate measure of the patient's needs and experiences but this has not been tested. This study is designed to learn if using a computerized assessment repeatedly is better than standard planning techniques.


Eligibility Criteria:
Inclusion Criteria:

1. Women who have a diagnosis of metastatic breast, gynecologic, thoracic, or gastrointestinal malignancy. Women diagnosed with non-solid organ tumors (i.e., lymphoma, leukemia) will be excluded as their symptom profile in advanced/metastatic disease is dissimilar.
2. Reason for admission must be for symptom management from cancer or cancer therapy.
3. Patients must be age 18 or older.
4. Only patients cared for at the Robert H. Lurie Comprehensive Cancer Center (RHLCCC) will be eligible for this small pilot study.
5. Patients must not be enrolled in hospice care.
6. Patients must have a performance status 0-3 (ECOG scale).
7. Patients must be alert and oriented to time, place, and person. Must be able to answer questions.
8. Patients must be able to speak, read, and communicate in English.
9. Patients must have a signed consent and authorization for research and be amenable to be followed for outcomes/response throughout and after hospitalization.

Exclusion Criteria:

-
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose \[2'FL\] and lacto-N-neotetraose \[LNnT\], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\], if applicable)
2. Infant's parent(s)/LAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol
3. Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound
4. Infant birth weight ≤ 2500g
5. Infant postnatal age ≤ 14 days
6. Infant has tolerated trophic feeds (e.g., 10-15 mL/kg/day) for at least 24 hours but has not yet reached full enteral feeding

Exclusion Criteria:

1. Infant is clinically unstable, for example:

   1. Infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (MAP \< 5th percentile for age for at least three hours), or is receiving vasopressor drugs
   2. Infant has received an exchange transfusion within the past 48 hours
   3. Infant has had an episode of severe asphyxia at birth (PH less than 7.0)
   4. Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)
2. Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)
3. Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
4. Participation in another interventional clinical study that may interfere with the results of this study
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

* Crohn's disease for ≥ 3 months on endoscopy and on histological exam
* Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
* Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
* Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
* Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria:

* Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
* Extensive small bowel resection (\>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
* Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply
Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

This is a randomized controlled trial comparing the use of the Mobius™ retractor to the use of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women. The Mobius™ retractor was designed for abdominal surgery to improve visualization of the surgical field through standard surgical incisions and is now a standard instrument used for cesarean deliveries at Thomas Jefferson University Hospital. We hypothesize that the use of the Mobius™ retractor during cesarean deliveries in obese women decreases operative time, blood loss, number of transfusions, infectious morbidity, incision length, and intra- / post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.

The Mobius™ retractor has been used in many obese cesarean deliveries based on the theory that it provides superior visualization. There have been no clinical trials to determine if this "added" exposure offers any measurable significant benefits to justify the added cost. This study will determine if the Mobius™ retractor does provide a measurable difference in outcomes, compared to the traditional retraction instruments.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women undergoing non-urgent cesarean delivery

Exclusion Criteria:

* women undergoing urgent cesarean delivery
* BMI \<35kg/m2
* women undergoing vaginal delivery
* positive urine drug screen or known history of methadone maintenance or substance abuse
Prevent CardioKids

The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.

The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.The primary endpoint is to examine the difference in micro- and macro-vasculature characteristics in children with different weight classifications (lean; overweight; obese; extreme obese; morbid obese). Secondary endpoints are differences in lipoprotein profiles, pro-inflammatory and oral glucose tolerance profiles between different age groups, between lean and overweight/obese children and in relation with the measured micro- and macro-vasculature characteristics

Eligibility Criteria:
Inclusion Criteria:

* Participation in the COACH program
* Aged between 6 and 18 years (at time of inclusion)
* Overweight or obesity according to IOTF criteria

In order to be eligible to participate in the control group, a subject must meet all of the following criteria:

* Aged between 6 and 18 years
* Normal weight according to the IOTF criteria
* Undergo surgery for elective reasons

Exclusion Criteria:

* Retarded children
* Children suffering from:

  * Inflammatory diseases: auto-immune diseases, inflammatory bowel diseases, hepatitis, dermatitis, nephritis, pancreatitis, gastro-enteritis, vasculitis, salpingitis, arthritis, osteomyelitis, myositis, ear-nose-throat infections
  * Allergic diseases: asthma, eczema, hay fever, food allergies
  * Oncologic diseases
  * Cystic fibrosis
  * Type 1 diabetes mellitus
  * Congenital metabolic diseases
* Malnourished children
New MRI Biomarkers in Head and Neck Cancers

Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.

The purpose of this study is to see if new MRI methods can give us more information about the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Group 1 patients: Presence of a suspicious metastatic lesion or suspicious for recurrent disease in the head and neck region.
* Group 2 patients:

  * Biopsy proven recurrent or metastatic or definitive head and neck cancer or (differentiated and undifferentiated) thyroid cancers in the head and neck region only.
  * Patients planning to undergo reatment at MSK

Exclusion Criteria:

* Patient would require anesthesia for the study
* Patients who are claustrophobic
* Patients selecting treatment outside of MSK
* Known reaction to Gd based contrast agent
* Patients who have presence of a known contradiction to MRI

  * Pacemaker
  * Aneurysm clips
  * Patients with implants that are contradicted for MR imaging will be excluded
  * Pregnant
  * Age and mental status wherein he /she is unable to cooperate for MRI study