cyrilzakka/clinical-trials huggingface dataset:
Developing a Nutrition Support Assessment Tool

The research team developed the Nutrition Support Assessment Tool (NSAT) that incorporates key patient life information (e.g., ability to cook, access to refrigerator/stove, medical conditions and nutritional status) to facilitate individualized nutrition referral. The overall goal of this study is to refine and test the NSAT as a systematic approach to provide individualized nutrition needs screening and referral for patients being discharged from the acute care setting at Jefferson Health. The investigators hypothesize the NSAT will be successful in identifying individualized nutrition referrals that are deemed acceptable and appropriate by enrolled participants.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Currently admitted to Thomas Jefferson University or Methodist Hospital or Emergency Department
* Has working phone number and is willing to participate in follow-up data collection
* Eats by mouth
* Lives in MANNA's geographic service area
* Patient reports food insecurity or malnutrition using existing screening tools

Exclusion Criteria:

* Unwilling to provide consent
* Unsheltered/unhoused
* Lives in or is being discharged to facility that provides daily meals (e.g., long term care, incarcerated)
* On hospice or has life expectancy of less than 4 months, per clinician
* Not consentable
* Deaf or has other major communication barriers that compromises ability to participate in study activities
Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed prostate cancer
* Presence of metastatic disease to the bone
* Ongoing androgen deprivation therapy

Exclusion Criteria:

* Severe concurrent disease
* Metastases in the brain
Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations

The purpose of this pilot study is to determine the utility of an algorithm for better glucose control in diabetic patients communicated via an App to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life.

The aim of the study is to determine the impact of GEM (glycemic emergency management device-app) in reducing the frequency and severity of hypoglycemia episodes in persons with diabetes. Other objectives include: to determine whether the GEM system leads to improved glucose control (as measured by HbA1c) during participation in the pilot, to determine whether the GEM can be used as a cost effective solution in reducing ER and urgent care visits, to determine the difference in ADDQOL scores between persons with a functioning GEM system and those with a placebo device. The Study hypothesis is as follows: There wil be significant differences in number of hypoglycemic events, ER and urgent care visits, A1C, as well as quality of life as measured by the ADDQOL scores between persons with diabetes who have the functioning GEM device in their smart phones and those that do not have such a device installed in their smart phones.

The purpose of this pilot study is to determine the utility of this application to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life in persons with diabetes. This approach may be a paradigm shift in the rapidly detecting, monitoring, intervening and managing the acute diabetic complications of hypoglycemia, hyperglycemia and diabetic ketoacidosis. Spiraling health care costs are a major concern to the economy of the US. New measures have been introduced in the Affordable Care Act to improve the efficiency of the health care delivery system. There is more emphasis on preventive health care services. Our study is a step in that direction since it utilizes existing smart phone technology and converts it into a medical device which can be of invaluable help to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes on therapeutic treatment other than just lifestyle changes
* Treatment by Marshall Internal Medicine Department
* Have a smart phone
* At least 6th grade education level

Exclusion Criteria:

* Pregnant women
* Cognitive impairment
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

Preconditioning in patients treated for elective abdominal aneurysm showed that the rate of perioperative myocardial infarction could be reduced by 80 %(ARR from 27% to 5%). Precondition where performed by 10 minutes of clamping of each iliac arteries before clamping the abdominal aorta. Human studies in cardiac patients have shown promising results with precondition. Instead of clamping arteries they have all performed the procedure by inflating a blood pressure cuff above arterial pressure on a arm.

The investigators want to investigate if preconditioning induced by a blood pressure cuff on a arm can reduce the perioperative rate of myocardial infarction in patients open operated for ruptured abdominal aortic aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ruptured abdominal aortic aneurysm offered surgery
* Age \> 18 years

Exclusion Criteria:

* Technical inoperable
Newborn Cortical Response to Pain and Non Pharmacological Analgesia

Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.


Eligibility Criteria:
Inclusion Criteria:

* Full term healthy infants, needing a heel-prick for metabolic screening;
* Informed consent obtained from parents.

Exclusion Criteria:

- Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)
Adjuvant Chemotherapy Compared With Observation in Treating Patients With Resected Early Stage Ovarian Epithelial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant therapy using platinum-based chemotherapy drugs with no adjuvant therapy in treating patients with early stage invasive ovarian epithelial cancer.

OBJECTIVES: I. Determine whether adjuvant chemotherapy with a platinum-containing regimen (e.g., carboplatin or CAP: cyclophosphamide/doxorubicin/cisplatin) prolongs survival in patients with early stage ovarian cancer compared to those receiving no adjuvant treatment.

OUTLINE: Randomized study. Patients are randomized to Arm I or II; treatment should begin within 6 weeks of surgery. Regimens listed in Arm I are recommended, but other platinum-containing regimens are allowed provided the doses at a minimum meet those listed below. Arm I: Single-agent Chemotherapy or 3-Drug Combination Chemotherapy. Carboplatin, CBDCA, NSC-241240; or CAP: Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; Cisplatin, CDDP, NSC-119875. Arm II: Observation. No adjuvant therapy.

PROJECTED ACCRUAL: A maximum of 2,000 patients will be randomized.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed invasive ovarian cancer of epithelial origin All tumor resected prior to randomization Uncertain whether immediate chemotherapy is required

PATIENT CHARACTERISTICS: Age: Any age Performance status: Sufficient to receive chemotherapy Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior malignancy except nonmelanomatous skin cancer No clear contraindication to chemotherapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Minimum recommended surgical procedures (when possible): Thorough surgical staging Total hysterectomy/bilateral salpingo-oophorectomy Omentectomy, as follows: Total supracolonic omentectomy if omentum involved Removal of distal 2 cm or infracolonic omentectomy in the absence of macroscopic disease
The Effects of Exercises on Gait in Hemophilic Individuals

Arthropathy characterized by synovitis, cartilage degeneration, subchondral and interosseous cysts occur due to hemorrhage in hemophilia. This situation causes to chronic pain, decreasing in range of motion, muscle strength, proprioception. Disorders in these parameters are the main causes of gait dysfunction. The aim of this study is to investigate the effects of therapeutic exercises on target joint functions and gait kinematics, and to determine possible complications related to exercise in hemophilic patients.


Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed as Hemophilia A or Hemophilia B
* To be over 18 years old
* To have hemophilic arthropathy in at least one joint
* Undergoing prophylaxis or factor VIII-IX replacement therapy

Exclusion Criteria:

* Having another congenital coagulopathy, such as Von Willebrand syndrome
* To be unable to walk due to hemophilic arthropathy
* Having another musculoskeletal problem
* Individuals with inhibitors against Factor VIII-IX
Echographic Measurement of Skin Thickness in Children

To optimize a medical device for intradermal injection, knowledge concerning the thickness of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is lacking, the investigators will examine the skin thickness (epidermis and dermis) of children (aged 8 weeks to 18 years) using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to a specific combination of parameters age, gender, and BMI.

Based on these results, the investigators can define which needle type and length is needed to correctly perform injections into the dermal layer


Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* Age: 8 weeks to 18 years
* Dutch-speaking
* Caucasian

Exclusion Criteria:

* Using ointment, crème, gels or oral medication based on corticoids
* Suffering from skin diseases (psoriasis, burning wounds)
* Pregnancy or lactating
HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors

A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

* 18Y≤Age≤75Y
* Good Organ Function
* Expected survival time ≥ 3 months
* Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment
* Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
* ECOG score 0-1;
* Expected survival time of more than 3 months;

Exclusion Criteria:

* Previous treatment with BRAF inhibitors or MEK inhibitors
* Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
* Current or former patients with interstitial lung disease;
* Active clinical severe infection;
* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
* Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
MicroCutter in Surgical Stapling - European Trial I

The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study.

A prospective, open label, multi-center non-inferiority safety study with an all-comers enrollment of patients requiring surgical stapling of the stomach and/or intestine according to the labeled indications contained in the approved labeling. Up to 178 subjects consented for a 1-month clinical follow-up evaluation will be enrolled. Primary endpoint is to statistical non-inferiority of composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) in study patients when compared to composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature. The comparison will be performed for cumulative events up to 30 days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

- All patients requiring surgical treatment where the use of a surgical stapler is anticipated

Exclusion Criteria:

- None
Administration of Low-level Laser on Muscles of Mastication Following the Induction of Initial Fatigue

Orofacial pain encompasses painful conditions, such as temporomandibular disorder. Multidisciplinary health teams seek to control such musculoskeletal disorders to improve the quality and functional capacity of the muscles of mastication. The aim of the proposed study is to evaluate the effect of low-level laser therapy as a form of treatment for the prevention of initial fatigue of the muscles of mastication (masseter and anterior temporal muscles) as well as the recovery of these muscles after induced exhaustion (caused by isometric contraction) in young adults. The participants will be 78 (n obtained from calculation of the sample size with p \< 0.05) healthy male and female volunteers between 18 and 34 years of age. The volunteers will be randomly allocated to a laser group (n = 26), sham group (n = 26) and control group (n = 26). All participants will be submitted to a clinical evaluation to record mandibular movements, bite force, muscle sensitivity to palpation and initial muscle fatigue. Initial fatigue will be induced by isometric contraction of the jaws. Maximum voluntary contraction will be performed to record the time until initial exhaustion of the masseter muscle (determined by electromyography). The groups will then be submitted to the interventions: 1) active laser therapy (wavelength: 780 nm; fluence: 134 J/cm2; power: 50 mW; irradiance: 1.675 W/cm2; exposure time: 80 seconds per point) on three points of the masseter and one point on the anterior temporal muscles on each side, 2) sham laser (placebo effect) or 3) no intervention (control). Maximum voluntary contraction will be performed again after the interventions to record the time until initial exhaustion of the masseter muscle (determined by electromyography). Differences in individual time until exhaustion between the pre-intervention and post-intervention evaluations will be measured to determine the effect of low-level laser therapy.


Eligibility Criteria:
Inclusion Criteria:

* will be included in this study young people in the age range between 18-34 years, without diagnosis of temporomandibular disorder (TMD) and with the signed free informed consent term.

Exclusion Criteria:

* will be excluded from the study individuals who are in orthodontic or orthopedic treatment of the jaw, psychological and / or physiotherapy. Also excluded are those who are taking anti-inflammatory drugs and anti-inflammatory drugs and occlusal plaques.
Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities

Does the addition of Platelet-Rich Plasma (PRP) to release of burn contractures and skin graft on the limbs of children with retractable burn sequelae reduce the initial time of the compressive treatment and maintain or lower the graft's retraction?

Hypothesis:

1. The use of PRP will allow to initiate sooner the compressive treatment during the post graft surgery evolution, in fewer days on average than the traditional method (18 ds).
2. The use of PRP will maintain the same initial size of the graft. The study's domain corresponds to burn sequelae on children in treatment with reconstructive surgery due to retractile sequelae located on their upper and lower limbs, with functional compromise during their growth process.

One of the treatments used for this problem is the surgical technique of with release of burn contractures and skin graft.

Split skin grafts are at risk of suboptimal "take" due to bleeding and infection which would, on the one hand, delay the initiation of the rehabilitation with preventive compression to avoid the retraction of the grafted area.

20% of the children that arrive in COANIQUEM (approximately 7,000 annually), require rehabilitation. Of these, 32% have surgery and 9% of those are release of burn contractures and skin graft mainly on extremities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with burn sequelae on their upper or lower limbs
* Treated with release of burn contractures and skin graft on their upper or lower limbs
* Between 5 and 21 years old
* Following instructions in their homes
* With informed and written consent
* Weight 35 Kg or more
* Blood count
* Hepatic and coagulation tests
* Paediatric evaluation prior to surgery

Exclusion Criteria:

* Background of blood alterations
* Another current pathology
The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery

Postoperative agitation in children is a well-documented clinical phenomenon with incidence ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the pediatric population and there is now increasing evidence to support the use of this drug as sedative and anesthetic adjunct in children. The purpose of this study is to determine whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.


Eligibility Criteria:
Inclusion Criteria:

* the patient undergoing the strabismus surgery in severance hospital

Exclusion Criteria:

* delayed development
* mental retardation
* cerebral palsy
* preoperative EKG abnormality e.g. cardiovascular conduction disorder
Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.


Eligibility Criteria:
Inclusion Criteria:

* Has at least a 1-year history of migraine with or without aura
* Age of the patient at the time of migraine onset \< 50 years
* History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
* Demonstrated compliance with e-diary

Exclusion Criteria:

* Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine
* Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
* Difficulty distinguishing migraine headache from other headaches
* Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
* Has a history of hepatitis within previous 6 months
* Usage of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs \[NSAIDs\], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
* Pregnant or nursing females
Effect of Core Stability Exercises on Hand Functions in Children With Hemiparesis

Background: Impaired upper extremity is the major disability facing the children with hemiplegia as the inability to use hands for reach; grasp and manipulation affect their daily life activities. little attention has been given to gain perspective about abnormal movements that are detectable in hemiplegic cerebral palsy that are related to one's level of core stability and how they affect their hand functions.

Background: Impaired upper extremity is the major disability facing the children with hemiplegia as the inability to use hands for reach; grasp and manipulation affect their daily life activities. little attention has been given to gain perspective about abnormal movements that are detectable in hemiplegic cerebral palsy that are related to one's level of core stability and how they affect their hand functions.

Objective: The purpose was to investigate the effectivness of core stability exercises on hand functions in hemiplegic cerebral palsy.

Methods: Thirty hemiparetic cerebral palsied children of both sexes, ranged in age from 6 to 8 years enrolled in this study. They randomly assigned into two groups of equal number. Group (A) received the selective physiotherapy exercises and group (B) received the same selective physiotherapy exercises program in addition to core stability exercises three times/week for 60 min for 12 weeks. Time motor performance, gross manual dexterity and skills of the upper extremity were assessed by using Jebsen Taylor Test (JTHFT), Box and Block Test (BBT) and Quality Upper Extremity Skill Test (QUEST) respectively before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* The level of gross motor function ranged from II to III, according to Gross Motor Function Classification System
* All participants are cognitively capable and competent of interpreting and following instructions

Exclusion Criteria:

* if they had fixed contractures or deformities of the spine, upper or lower extremities,
* visual or respiratory disorders, orthopedic surgery on their involved upper extremity;
* dorsal rhizotomy;
* botulinum toxin therapy in the upper extremity musculature during the past 6 months
* who wished to receive it within the period of study