cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in Predicting Response to Chemotherapy in Patients With Advanced or Metastatic Melanoma Previously Treated With Carboplatin and Paclitaxel With or Without Sorafenib Tosylate

RATIONALE: Studying samples of tissue in the laboratory from patients receiving carboplatin and paclitaxel with or without sorafenib tosylate may help doctors learn more about the effects of this treatment on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in predicting response to chemotherapy in patients with advanced or metastatic melanoma previously treated with carboplatin and paclitaxel with or without sorafenib tosylate.

OBJECTIVES:

* To independently correlate the gene expression and promoter methylation profiles to chemotherapy response in patients with advanced or metastatic melanoma treated with carboplatin and paclitaxel with versus without sorafenib on clinical trial ECOG-E2603.
* To develop a predictive model of chemotherapy response utilizing integrated analysis of gene expression and promoter methylation data.
* To evaluate whether the NER pathway haplotypes are associated with platinum drug resistance and survival.

OUTLINE: This is a multicenter study.

Archived paraffin-embedded tissue samples are analyzed for gene expression and promoter methylation profiles, and genes involved in the NER pathway.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of melanoma

  * Unresectable locally advanced or stage IV disease
* Received carboplatin and paclitaxel with versus without sorafenib on clinical trial ECOG-E2603
* Archived paraffin-embedded tissue samples

  * Responder (complete or partial response, or stable disease) and non-responder (disease progression or unavailable)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

The purpose of this study is to determine if multiple vaccination in military personnel may be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome, autoimmune or lymphoproliferative disorders. At the same time, considering possible interference between different vaccines, proteins and polysaccharides, living and inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the specific Human Leucocyte Antigens (HLA) genetic structure.


Eligibility Criteria:
Inclusion Criteria:

* Military volunteers
* No recently immunized

Exclusion Criteria:

* Pregnancy
* Documented immunodepression
* Documented allergy or hypersensitivity to vaccines
Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact

The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about one-third were Duodopa-naïve prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

- Advanced idiopathic Parkinson's disease

Exclusion Criteria:

- Other diseases which might influence compliance or participation in the study
Stretching and Yoga Exercise Study

The investigators propose to test the effects of an 8-week supervised, site-based, group yoga intervention on cognition and functional fitness in older adults. The SAY Exercise study will compare the yoga group to a stretching group to determine if the program improves attention and cognition, reduces functional limitations, enhances functional performance in everyday activities, as well as psychological health in sedentary older adults between 55-80 years of age. The investigators also propose to assess heart rate variability using a 3-lead EKG and salivary cortisol levels to understand the moderators of the yoga-cognition relationship.


Eligibility Criteria:
Inclusion Criteria:

* 55-80 yrs of age
* Low active: zero to two days of physical activity (\>30 minutes per day) per week, in previous six months
* Personal physicians consent to participate in testing and exercise intervention
* Not involved in any other physical activity/exercise research study or cognitive training study.
* Adequate responses to the Telephone interview of Cognitive Status (TICS-M) questionnaire
* Corrected (near and far) acuity of 20/40 or better in both eyes
* Initial depression score on GDS-15 below clinical levels (\>5)
* Able to get up and down from the floor
* Comfortable with reading, writing and speaking English

Exclusion Criteria:

* Below 55 or over 80 years of age
* High physical activity levels (more than 2 times per week, \>30 minutes, in the last 6 months)
* Regular yoga practitioners (previously or currently practicing for more than 6 months)
* Involved in other physical activity/exercise research study or cognitive training study
* Non-consent of the physician
* Inadequate response on the GDS-15 and TICS-M
* Uncorrected (near and far) acuity of greater than 20/40 in either eye
* Inability to communicate effectively in English
* Intent to be away from the area for a long period of time resulting in more than 2 absences at the exercise sessions
Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit

The femoral approach is the preferred vascular access for the set-up of emergency catheters in severely traumatized patient. This location combines simplicity and speed of installation, it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few complications and failures.

The ultrasound guidance has greatly reduced installation times, failures and complications related to the set-up of central venous catheter. This was amply demonstrated in the internal jugular and subclavian site outside of extreme emergency situations (Fragou M et al 2011, Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for the set-up of arterial and venous catheters in the femoral emergency has not been evaluated in terms of reduction in complications.

Then the main objective of this study is to demonstrate that the ultrasound guidance reduces early complications related to the set-up of arterial and venous catheters in the femoral emergency, among severely traumatized patient compared to the reference anatomical technique.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Included in intensive care unit for severe trauma
* Need for implementation of femoral arterial and venous catheters in accordance with the practices of the service.
* Agreed to participate
* Affiliation to national security

Exclusion Criteria:

* Contraindication to the set-up of vascular access in femoral position (femoral Scarpa wound, aortic dissection)
* Local infection
* Hypothermia \<32°C
* Need for implementation of arterial catheter only
* Need for implementation of venous catheter only
Effect of Concentrated Growth Factors on Short Implant-Supported Overdentures

The purpose of this study will be to evaluate the effect of concentrated growth factors on stability and radiographic outcome of short implant supported mandibular assisted overdenture

A controlled clinical trial will be performed upon patients attending the outpatient clinic of Faculty of Dentistry Tanta University.Ten male patients will be selected for this study. Split mouth study design will be used in this study where, Group I represented the right side of the patients' mandibular posterior region will be restored with short implant in place of first molar and Group II represented the left side of the patients' mandibular posterior region will be restored with short implant in place of first molar and concentrated growth factors. The patients will receive partial mandibular assisted overdenture with O-ring attachment on the implant. Stability of implant and Radiographic evaluations will be carried out for every patient at regular recall visits at the time of insertion, 6 and 12 months

Eligibility Criteria:
Inclusion Criteria:

* Patients between 20 to 65 years old. Class I Kennedy's classification Good oral hygiene.

Exclusion Criteria:

* Bad oral hygiene. Para functional habits ex. (bruxism, clenching,)
Cardiopulmonary Assesments in Mood Disorders

The importance of cardiorespiratory impact in mental diseases is generally emphasized in studies, but it is noteworthy that cardiorespiratory affects in mood disorders have not been sufficiently investigated. This study aims to compare individuals with mood disorders and healthy people in terms of exercise capacity, functionality, respiratory muscle strength, respiratory functions, dyspnea and physical activity level.

The cross-sectional study was carried out with 30 patients with diagnosis of mood disorder who applied to the Hatay Mustafa Kemal University Research and Practice Hospital, Mental Health and Diseases clinic, and 35 healthy individuals whose age, gender were matched. Clinical characteristics, exercise capacity (6-minute walking test, 6MWT; 3-minute Step test, 3MST), functionality (vertical jump test, functional reach test), respiratory parameters (Respiratory muscle strength, pulmonary function test), dyspnea (Modified Medical Research Council, MMRC scale), physical activity level (short form international physical activity questionnaire, IPAQ) was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who had undergone a general physical examination in the past 6 month
* reported being free of significant cardiovascular, respiratory, neuromuscular, and endocrine disorders that preclude safe participation

Exclusion Criteria:

* Individuals with significant cardiovascular, neuromuscular and endocrine disorders,
* pregnant women,
* people under 18 years old
* disabled individuals.
Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health

The Investigator would like to see if taking a DHA supplement at a dose recommended for heart health will improve brachial artery dilation (relaxation) and help blood pressure. As a second goal the Investigator would like to see if this supplement can delay preterm delivery by improving heart health. In this research study, the Investigator is asking pregnant women with chronic high blood pressure to take Expecta (DHA - Martek Biosciences, now known as DSM Nutritional Lipil) during the last half of their pregnancy until six weeks after they deliver their baby.

The Investigator will be supplementing pregnant mothers with Expecta. This is an over the counter supplement often used by pregnant and nursing mothers and will be given to expectant mothers during the research study. This DHA supplement is available to anyone at most any store. The dose often used over the counter is 200mg, we are testing the heart recommended dose of 1000mg. Because the Investigator is using the heart health recommended dose and because there may be a health claim, the Investigator is doing the study using an FDA- food and drug administration IND. IND means investigational drug. This dose has recently been used safely and effectively in pregnancy both here in the United States and in Australia in hundreds of women. There are no risks to the fetus as the placenta prefers to transfer this important nutrient for fetal eye and brain development. The large studies done in pregnancy have followed their babies into school age and found no adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women coming for their 19-20 week ultrasound for fetal anatomy and that have been diagnosed with hypertension by their Obstetrician will be eligible for inclusion.

Exclusion Criteria:

* Exclusions to enrollment will include: women \< 18 years old
* Bleeding disorders
* Lupus
* Autoimmune diseases
* The presence of infant congenital (trisomy 13,18, 21, urethral, gastrointestinal and cardiac defects)
Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis: Patient Experiences and Reported Outcomes.

This study utilizes a grounded theory methodology to explore patient experiences of phrenic nerve reconstructive surgery as a treatment for diaphragmatic paralysis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a confirmed diagnosis of Diaphragmatic Paralysis.
* Individuals who are scheduled to undergo phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.

Exclusion Criteria:

- Individuals who do not comprehend the English language.
Promoting Child Development Practices in the First Year of Life Through a Video Administered at Two Different Times

There is an increasing need for parenting programs aimed at promoting parent-child interaction. A variety of interventions have been proposed. The use of audiovisual materials for parents has been shown to be effective but limited information is available on the optimal timing for its use, particularly for new parents during the first year of life of their children.

Based on the hypothesis that the effectiveness of information provided to first-time parents in modifying their knowledge, attitudes and intentions regarding rearing practices may depend on when the information is delivered, we designed an open randomized controlled trial to compare the effectiveness of administering a video at two different times, i.e. at one and seven months of age of the child.

The video addressed four specific activities related to early child development: reading aloud to the baby, early exposure to music, promotion of early socialization for parents and for children.


Eligibility Criteria:
Inclusion Criteria:

* first parenting experience
* local residence
* no major health or psychosocial problems in parents and in the newborn
* no delay in discharge from the maternity ward
* adequate knowledge of Italian

Exclusion Criteria:

* None
Effect of Neuro Developmental Therapy in Infants With Down Syndrome

Neurodevelopmental treatments are a progressive therapeutic method experienced thru qualified therapists for the improvement in affected ones. The most important trial in Down syndrome children is motor milestones and postural reactions to develop on time.

Neurodevelopmental therapy is applied to accurate atypical postural tone and to enable further regular motion for execution of presentation of abilities. Objective: To determine the effects of Neuro Developmental therapy in improving postural reaction and motor milestones in infants with Down syndrome.

This study was a randomized trial design. This study was conducted in Rehab Care Physiotherapy Department. 20 Children with Down syndrome meeting the predetermined inclusive and exclusive criteria were arbitrarily allocated into dual batches through convenient sampling technique. The first batch which was the experimental group was given Neurodevelopmental therapy and the duration of the treatment comprised of 1.5 hour, three days a week for 6 weeks. The second group which was the control group received conventional therapy and the period of the ministrations comprised of 1 hour, with 10 repetition 3 sets for each muscle three days a week for 1.5 months, Pre-assessment and post-assessment was evaluated through Gross motor function-88. Recorded values were analyzed through SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Trisomy 21 by genetic karyotype.
* Down syndrome children with delayed milestone.
* Definite identification of Down syndrome by neurologist.
* Children having the average birth weight above 2.500 grams and average birth length above 49.52 cm.
* Laxity, low muscle tone and psychomotor development deficits

Exclusion Criteria:

* Infants with Heart Defect.
* Seizure.
* Critical orthopedic difficulties or deformities (hip instability, patellar instability, foot deformity).
* Unrestrained thyroid conflicts.
* Perilabour asphyxia (Apgar of minutes 1 and 5 equal to or less than 7).
* Critical optical or acoustic disorders.
* Mass below the 3rd percentage of Down syndrome
Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis

POPB is a consequence of the stretching of the nerve roots (C5, C6 + / C7, C8 or T1) of the brachial plexus at birth. One third of patients will have sequelae. The most common is the appearance of a deficit of passive and active mobilities in the movements in external rotation of the shoulder especially in external rotation (RE) elbow to the body, despite daily rehabilitation. At present, this stiffness is attributed to an imbalance between the external rotator muscles (mainly infraspinatus) that would be atrophied and the internal rotator muscles (subscapularis, pectoralis major, latissimus dorsi) that would be slightly affected In case of no or negative RE from the age of 1 year, there is a surgical indication to operate these children. At present, surgery to lift internal retractions is the only therapy used, but despite this surgery and intensive rehabilitation, in some patients mobility deficits re-occur in a few years. Thus, some teams systematically perform a muscle transfer to strengthen the outer rotator muscles deficit during the initial operation. Other teams (of which principal investigator is part) do this transfer only secondarily and in some patients. Investigators lack objective and scientific criteria for the indication of this second muscle transfer surgery and the etiology of retractions is not clearly defined.

In humans, subscapularis is innervated by the C5 and C6 roots, which are constantly affected in POPB. It can be assumed that subscapularis may have an atrophy in POPB patients. To date, no anatomopathological study has been performed on the internal / external rotator muscles of patients with POPB that can give indications on recurrences.

Based on our clinical observations and literature data, the main hypothese is there is amyotrophy of subscapularis and / or infraspinatus in POPB patients with shoulder stiffness.


Eligibility Criteria:
Inclusion Criteria:

* Child with POPB presenting a stiffness in external shoulder rotation after the age of 1 year with a surgical indication of anterior release of shoulder is asked
* Obligation to obtain written informed consent from parents.

Exclusion Criteria:

* Patient with another neuromuscular pathology
* Significant traumatic history of the upper limb (fracture or surgical intervention) or any other pathology affecting the mobility of the joints of the upper limb (either on the pathological side or on the healthy side)
* Patient with a contraindication to surgery (precarious general condition, major coagulation disorders, anesthetic contraindication)
* Child over 10 years old
* Refusal of the patient or family
Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision

Building upon prior work, the investigator team developed a communication intervention for older adults with ADRD who are considering a decision about cancer management (adapted intervention: COACH-Cog). The investigators hypothesize that for patients with dual diagnoses of ADRD and cancer, COACH-Cog will increase autonomy support of care partners and patients in the decision-making process, leading to greater acknowledgement and support of cognitive concerns and cognitive-related goals, thereby improving goal concordant care. The investigators are conducting a pilot randomized controlled trial (RCT; cluster randomized by physician) including approximately 45 oncology clinicians and 130 patient/care partner dyads evaluating the effect of COACH-Cog on care partner and patient autonomy support, care partner well-being, goal-concordance, and communication.


Eligibility Criteria:
PATIENTS:

Patient Inclusion Criteria:

1. Be age 65 or older
2. Have a clinical diagnosis of Alzheimer's disease or related dementia (ADRD \[Alzheimer's disease, vascular dementia, Lewy body dementia, frontotemporal dementia, or dementia of unknown subtype\])
3. Have a clinical diagnosis of cancer (any type or stage)
4. Anticipate a potential decision about cancer-related management, as confirmed by the patient's primary medical oncology clinician.
5. Have a care partner willing and able to participate in the study
6. Are able to read and understand English. The communication coaching session will be delivered in English, thus necessitating this requirement.
7. Be able to provide informed consent (as measured by UBACC) or have a Legally Authorized Representative to provide informed consent

Patient Exclusion Criteria:

Patient exclusion criteria: None

CARE PARTNER:

Care partner inclusion criteria:

1. Age 18 or over
2. Able to read and understand spoken English
3. Able to provide informed consent

Care partner exclusion criteria:

None

ONCOLOGY CLINICIAN:

Oncology clinician inclusion criteria:

1. Oncology clinicians affiliated with the Wilmot Cancer Institute
2. Do not intend to move or retire within the next 2 years.

Oncology clinician exclusion criteria:

None
Supplementation With GKEX Sports Probiotic Combo for Muscle Gain and Fat Loss Assessment

Objective: To discuss the "GKEX Sports Probiotics Combination (hereinafter referred to as GKEX)", a product commissioned by Grape King Biotechnology Co., Ltd., and its effects on increasing muscle mass, muscle strength, physical performance and improving body composition when combined with resistance exercise training. Method: The experiment adopts a double-blind design. After screening, 52 subjects (20 males and 32 females) were randomly divided into two groups, each with 10 males and 16 females: (1) placebo without GKEX probiotics Capsule group (Placebo) (2 capsules/day), (2) GKEX group (GKEX) (1x1010 CFU/capsule, 2 capsules/day). All subjects received daily supplementation samples for 6 weeks and received resistance exercise training three times a week. Before the intervention and 6 weeks after the intervention, the diet evaluation, systemic and resistive body composition, muscle ultrasound, muscle strength, maximum oxygen uptake, explosive power, anaerobic power, etc. were detected respectively.


Eligibility Criteria:
Inclusion Criteria:

* The tissues and organs of the body are functioning normally
* no disease, fatigue, or weakness
* independent and flexible activities

Exclusion Criteria:

* With a history of cardiovascular disease, hypertension, metabolic disease, asthma or cancer diagnosed by a physician
* BMI≧27
* Who have taken anti-inflammatory analgesics or acute and chronic diseases within one month, etc.,
* The students and related stakeholders guided by the host of this plan
* Who have the habit of smoking and drinking
* Within two weeks Have used probiotic products in powder, capsule or tablet form (including yogurt, yogurt, Yakult and other related foods)
* Food or allergic to lactic acid bacteria products
* Have had hepatobiliary and gastrointestinal surgery within 2 years (except hernia and polypectomy)
Pathophysiology Analysis of "Costello Syndrome" on Cellular Models

The objective is to collect skin biopsies rom patients with Costello syndrome to analyze the molecular mechanisms responsible for this syndrome caused by a mutation in the HRAS gene and the effects of this mutation on energy metabolism and mitochondrial physiology.


Eligibility Criteria:
Inclusion Criteria:

* Children aged over 2 years and under 18
* Children with a Costello Syndrome or Syndrome Cardio-Facio-Cutaneous

Exclusion Criteria:

* Previous history allergic to anesthetics