cyrilzakka/clinical-trials huggingface dataset:
A Randomized Study of Early Palliative Care

The purpose of this research study is to find out whether it is better to introduce cancer patients to the palliative care team at a later date when there is a specific issue or problem or to introduce cancer patients to the palliative care team when first diagnosed before any specific issue or problem occurs.

The investigators will conduct a one-year randomized, controlled study to evaluate the impact of an early, integrated palliative care services. The intervention will include comprehensive palliative care services delivered in conjunction with standard oncology care and patient friendly materials for high risk oncology patients. The investigators primary clinical endpoint will be health related quality of life, specifically focusing on measures of anxiety, depression, and well-being.

Secondary personalized palliative care outcomes are expected to include:

* Reduced deviations from care plan as captured in the medical record compared to the group who did not receive early, integrated palliative care services
* Reduced hospital utilization compared to the group who did not receive early, integrated palliative care services

Eligibility Criteria:
Inclusion Criteria:

* -Adults with newly diagnosed pancreatic, hepatocellular, esophageal, or stomach cancer
* Upcoming scheduled oncology clinic visit (2nd visit to the clinic) at Vanderbilt
* Ability to read and respond to questions in English
* Permission of oncology physician

Exclusion Criteria:

* -Receiving oncology care at non-Vanderbilt sites (to ensure appropriate follow-up)
* Participation in another clinical trial
VR Training on Hand-Eye Coordination and Reaction Time in Students

Virtual reality (VR) is a three-dimensional image, which is created by means of computer programs. In most educational communities VR has been used as an opportunity to support many students. VR allows the user to observe the world generated for their own needs as the real world and experience impressions that are not available in real life. It was decided to examine how immersive VR-game will affect the eye-hand coordination on reaction time on students. The experimental group received a five-day training sessions using immersive VR game "Beat Saber", while control group was inactive comparator.

Eye-hand coordination can be defined as the ability to perform activities that require the simultaneous use of eyes and hands. Eye-hand coordination supports our daily activities, interactions with objects and people, and is critical to understanding how the brain creates internal models of the space and generates movement within it. Along with the development of technology, opportunities for stimulation of eye-hand coordination with the use of technical novelties have appeared. Virtual reality (VR) is a three-dimensional image, which is created by means of computer programs. It has become one of the technologies that offer many possibilities of application and use of its various aspects that can bring great benefits in the real world. In most educational communities VR has been used as an opportunity to support many students. It can be assumed that VR can help trainers or teachers, especially music teachers, by interacting through movement, realization and graphic images, to develop and shape skills such as eye-hand coordination. The use of virtual reality gives a wide range of possibilities for training, so it was decided to examine how it will affect the coordination of the eye-hand and reaction time in students.

Eligibility Criteria:
Inclusion Criteria:

* acceptance to participate in the research,
* age 18-27

Exclusion Criteria:

* diagnosed neurological diseases,
* fear of wearing goggles
* diagnosed diseases or injuries of the musculoskeletal system
* regular sports activities during the week.
The Use of Metformin in Early Breast Cancer Patients Pre-Surgery

The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.

Patients will take metformin twice a day for 3 weeks before surgery. The hypothesis is that metformin will reduce cell proliferation rates (Ki67) and increase apoptoses (TUNEL)in tumor tissue.

The study will collect and analyze pre- and post-treatment blood specimens for:

* Serum glucose
* Insulin levels
* Estradiol
* HOMA test
* Glycosylated haemoglobin

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer T1 or T2, Nx
* Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion Criteria:

* Diabetes or baseline glucose or Glycosylated haemoglobin upper limit of normal for the institution
* Recent use of corticosteroids
* AST \> 1.5 times upper limit of normal for the institution
* Pregnancy
* Serious clinical illness
* Prior or concurrent systemic neoadjuvant Breast Cancer therapy.
Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity

The purpose of this study is to test resting state functional Magnetic Resonance Imaging (rsfMRI) scans to see if rsfMRI scans are better than the standard task based fMRI scans at diagnosing or monitoring central nervous system lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Immunocompetent patients with newly diagnosed or recurrent non-Hodgkins lymphoma involving the brain (primary or secondary), as demonstrated by MRI and histologic confirmation either by positive CSF cytology for lymphoma or a monoclonal lymphocyte population defined by cell surface markers, vitreous or uvea biopsy or brain biopsy
* Age 18-80 years
* Treatment plan for HDC-ASCT
* Fluent in English
* Patients who in the judgment of the investigators and/or consenting professional, are able to understand the purpose of the study and provide informed consent will be included.

Exclusion Criteria:

* Claustrophobia
* Any contraindication to the use of contrast and/or general guidelines for MR imaging as per standard Department of Radiology imaging guidelines
* Unable to cooperate for MRI
The Effect of Chamomile on Healing After Tooth Extraction

After impacted wisdom tooth extraction, patients frequently complain of pain, edema, and limited mouth opening. After the procedure, patients are routinely recommended to use chlorhexidine and physiological serum-based mouthwashes. The antibacterial and anti-inflammatory effects of warm chamomile tea have been reported in the literature. In addition, the neuroprotective, antiallergic, antioxidant, antiseptic and spasmolytic properties of chamomile have been reported. The aim was to compare the effects of these gargles in terms of pain, mouth opening, burning sensation in the mouth, edema, and discoloration of the tongue and teeth.

The study was planned to be applied to 120 patients, 40 in each group. In the ASA 1 group, the mouth opening of the patients was recorded before the tooth extraction procedure. Impacted teeth were extracted using Ultracain D-S Forte (Articaine HCl: 40mg/ml, Epinephrine HCl: 0.012 mg/ml) as a local anesthetic. Dental units were prepared under sterile conditions. The patients were covered with a sterile drape. The lower wisdom tooth was extracted with open (surgical) extraction. The mucoperisoteal flap was lifted with a number 15 surgical scalpel, and the tooth was extracted using round and fissure-tipped steel burs with a handpiece. After tooth extraction, if there was granulation tissue in the extraction socket, it was curetted and irrigated with physiological serum \[sodium chloride: 0.009 g/ml, sodium 154 (mEq/I), chloride 154 (mEq/I)\]. After bleeding control, patients were given written and verbal postoperative advice. Antibiotics and analgesics were prescribed to patients, chlorhexidine gargle was recommended to 30 patients, saline gargle to 30 patients, and chamomile tea gargle to 30 patients. Patients were given VAS pain scores, numbered 0-10, to record for 7 days after extraction. Patients were called back to the clinic on the 2nd and 7th days after tooth extraction to assess pain, burning sensation and color change in the tongue, mouth opening, and edema. Sutures were removed on the 7th postoperative day.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I patients,
2. did not have the medical history of being allergic to local anesthesia
3. did not have the medical history of being allergic to CHX,
4. did not have acute infection at the tooth area
5. absence of any pathology at the area.

Exclusion Criteria:

1. Participants with medically compromised condition,
2. pregnant females
3. smokers
CIS001 Extension Study of Cyclosporine Inhalation Solution

This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

1. Enrollment in study CIS001
2. Written informed consent for CIS002
3. Use of an effective means of contraception by women of childbearing potential

Exclusion Criteria:

1. Any unresolved or irreversible CIS-related ongoing serious adverse event
2. Subjects who have developed newly emergent conditions, injuries, diagnoses, physical examination findings, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk of treatment complications
3. Subjects with suspected or documented allergy to propylene glycol and/or cyclosporine
4. Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
5. Women who are breastfeeding
6. Subjects unable to comply with all protocol requirements and follow-up procedures
7. Subjects who discontinued from CIS002 to participate in another clinical trial and have received any investigational treatment (other than CIS) within 14 days of titration visit 1/baseline.
Benefits of Trimetazidine in MASLD Patients

Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD

the study will evaluate the possible benefits of trimetazidine when added to pateints with metabolic associated fatty liver disease

Eligibility Criteria:
Inclusion Criteria: participants were included if they met MASLD diagnostic criteria, which required imaging-confirmed hepatic steatosis (via abdominal ultrasound and CAP), along with metabolic factors (BMI ≥25 kg/m², diabetes/dysglycemia, blood pressure ≥130/85 mmHg, triglycerides ≥150 mg/dL, or reduced HDL-cholesterol)

Exclusion Criteria: The study excluded those with

* alternative steatosis causes (alcohol intake \>50 g/day women or \>60 g/day men
* drug-induced injury, hepatitis C, Wilson disease).
* Additional exclusion criteria covered ages below 18 years, pregnancy. decompensated cirrhosis, portal hypertension, hepatocellular carcinomas.
* Trimetazidine contraindications (Parkinson's disease, parkinsonian symptoms, tremors, severe renal impairment)
Physical Therapy After Anti-spastic Treatment in Children With Cerebral Palsy

It is the primary purpose of this pilot study to investigate if physical therapy with strength training is better at improving muscle and gait function after anti-spastic treatment with Botulinum toxin compared to physical therapy without strength training in children with cerebral palsy. The investigators hypothesize that it is.


Eligibility Criteria:
Inclusion Criteria:

* cerebral palsy (diplegia and hemiplegia)
* indication for anti-spastic treatment with Botulinum toxin

Exclusion Criteria:

* fixed contractures
The Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries

Patients with radiation induced injuries experience significant pain and negative effects on quality of life. Currently, no standard therapy for these patients exists, with some patients treated symptomatically, and others treated with hyperbaric oxygen or pentoxifylline/Vitamin E. This study will examine prospectively the safety and efficacy of using a regimen of pentoxifylline and vitamin E in patients with late radiation induced injuries.


Eligibility Criteria:
Inclusion Criteria:

* Clinically documented symptomatic radiation induced injury (e.g. fibrosis, necrosis, ulceration)
* Prior treatment with radiation therapy to the affected area - completed at least 3 months prior to study entry
* Pain in irradiated volume after 3 months (not attributable to acute inflammation)
* ECOG performance status must be 0, 1 or 2
* Life expectancy is greater than 6 months
* Age 18 to 75 years; informed consent

Exclusion Criteria:

* Patient is still responding to other therapies for soft tissue injury
* Active malignant disease
* Any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment, including but not limited to, acute myocardial infarction, severe coronary artery disease, active internal bleeding or a history of hemorrhagic diathesis, peptic ulcer, impaired kidney or liver function
* Pregnant or lactating women
* No contraindication to treatment with pentoxifylline. (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine, recent cerebral and/or retinal hemorrhage)
* Concurrent treatment with warfarin or other anticoagulant, or with erythromycin
* Concurrent treatment with other experimental agents or other treatment for fibrosis
* Patients treated with radiotherapy for breast cancer 3 months to 3 years prior to study entry
* Blood pressure \< 90/60 mm Hg or orthostatic hypotension
Double-Blind Comparison Between Mitiglinide and Nateglinide in Type 2 Diabetic Patients

The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy

Exclusion Criteria:

* Type 1 diabetes patients
* Patients who require treatment with insulin
* Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy)
* Patients with severe ketosis, diabetic coma or precoma
* Patients complicated with severe hepatic diseases
* Patients complicated with severe renal diseases
* Patients complicated with severe hypertension
* Patients complicated with severe cardiac disease
* Pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period
CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial

Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered directly to the area near the herniated disc, can improve the pain and functional disability associated with a herniated disc.


Eligibility Criteria:
Inclusion Criteria:

* Adults \<60y
* \< 1m of symptoms
* Symptoms consistent with herniated disc
* MRI demonstrates corresponding disc
* Back pain resulting in functional disability

Exclusion Criteria:

* Chronic pain
* Daily pain medication
* Frequent back pain
* On the job injury
Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer

To evaluate the benefit of multidisciplinary specific follow-up of patients with a healed diabetic foot ulcer at the rate of two annual consultation on wound recurrence.

Diabetic foot ulcer is a major world health problem with a very high recurrence rate, 50% at two years.

The main causes of diabetic foot ulcer recurrence are inadequate footwear, lack of podology care and lack of self-care. International recommendations call for regular podological monitoring to prevent recurrence of diabetic foot ulcer.

The "remission foot" consultation assesses recommended items and is offered to any healed patient at the rate of two annual visit.

A retrospective study on multidisciplinary specific follow-up may show a real efficacity on recurrence rate.

Eligibility Criteria:
Inclusion Criteria:

* Patient with type 1 ou type 2 diabetes followed-up in Centre Hospitalier Sud Francilien,
* Discharge from hospital for diabetic foot ulcer between 2017 and 2019 and post-healing follow-up for two years,
* 18 years of âge or older,
* Person not deprived of liberty,
* person who was informed of and did not object to the study.

Exclusion Criteria:

- Person refusing the study.
Aneurysm Study of Pipeline in an Observational Registry

The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.


Eligibility Criteria:
Inclusion Criteria:

(All sites, All countries)

1. At least 1 Pipeline placed for treatment of an ICA
2. Patient or patient's Legally Authorized Representative (LAR) has signed an IRB- or EC-approved informed consent form, if required
3. Patient is willing and able to comply with follow-up visits

United States: Additional Inclusion Criteria for subjects enrolled in the United States:

4US) Subjects who are age 22 or higher 5US) IA of at least 10 mm in maximum dimension along the internal carotid artery between the petrous and superior hypophyseal segments

Canada: Additional Inclusion Criteria for subjects enrolled in Canada:

4C) In Canada, the Pipeline™ Embolization Device is intended for use with or without embolic coils for the treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping.

5C) Canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter.

France: Additional Inclusion Criteria for subjects enrolled in France:

4F) Unruptured IA, saccular or fusiform with an aneurysm sac diameter \> 15mm and not treatable with other current therapies ( EVT with coils with or without assisting system (intracranial stent) or balloon remodeling, or surgery) due to its specific morphology.

5F) IA previously treated with unruptured recanalization of the aneurismal sac \> 7 mm, not treatable with conservative treatment.

Exclusion Criteria: (based on contraindications PED IFU)

1. Active bacterial infection
2. A patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated
3. A patient who has not received dual antiplatelet agents prior to the procedure
4. Pre-existing stent is in place in the parent artery at the target aneurysm location
5. Angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing
6. Acutely ruptured aneurysm, defined as rupture of the target aneurysm Each site should refer to their country specific Instructions for Use/Approval(France) to determine final eligibility into the ASPIRe Registry.
Statin Eligibility Prior to Myocardial InfarCtion

The study (Statin Eligibility Prior to myocardial infarction (MI) in Jordanians, StatinEPIC) is

1. Cross sectional
2. Non interventional
3. One encounter per patient. No follow up. It addresses a major issue of primary prevention in Jordanians especially the young population, namely the issue of lipid lowering agents before sustaining an acute MI. A recent study in USA showed that 50% of patients who sustained MI were not eligible to statins had they been evaluated before the heart attack. It is largely unknown if a larger percentage of Middle Eastern patients who sustain a heart attack would be eligible to receive lipid lowering agents.
4. The PI will overlook the whole process. Dr Ahmad Tamari, the assistant to the PI will asses this whole process of data collection, management and manuscript drafting.

Statins, when use as primary cardiovascular prevention strategy, have been shown to lower future acute cardiovascular events, especially myocardial infarction. However the use of statins in this context (i.e., primary prevention) is governed by guidelines that limit the use of statins to four high risk populations: (1) hose with known cardiovascular disease, (2) those with low-density lipoprotein cholesterol (LDL-C) levels 190 mg/dl or above, (3) diabetics with LDL-C levels 70-189 mg/dl, and (4) those with an estimated 10-year atherosclerotic cardiovascular disease risk score of 7.5% or more.

Unfortunately, some individuals are still at risk of sustaining MI despite the fact that they do not fit into one of these four high risk groups eligible for statins.

StainEPIC will enroll consecutive patients admitted with MI who are not on statins to examine their eligibility for these medications based on the AHA/ACC guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Adults admitted with MI, age 30 to 75
* known lipid profile

Exclusion Criteria:

* on statin before enrollment
Environmental & Genetic Influences on Vitamin D Status

The purpose of this study is to determine the effect of environmental and genetic influences on Vitamin D status.

Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is solar exposure, with cutaneous synthesis of vitamin D by photoconversion of 7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin pigmentation, and age are recognized factors that influence how much vitamin D can be made by solar exposure. Surprisingly, Vitamin D deficiency has been described in people dwelling in southern Florida and in surfers in Hawaii. We hypothesize that genetic variations in vitamin metabolism accounts for these differences.

Eligibility Criteria:
Inclusion Criteria:

* Able to consent and come for a study visit.
* Male or female between ages 18-60.
* Sun exposure \>3 hours daily for at least 5 days weekly for the last 3 months.

Exclusion Criteria:

* Unable to consent or come to a visit
* Taking Vitamin D supplements, anticonvulsants, barbiturates, steroids, having granulomatous disease, or liver or kidney disease as these medications and conditions interfere with Vitamin D metabolism.
* Related to another participant by blood.
Effectiveness of Blood Flow Restricting Exercises and Isokinetic Exercises in Female Football Players

Our aim in the study is; Comparison of blood flow restrictive exercises and isokinetic exercises in female football players. 30 female football players between the ages of 18-30 who came to DOIT Health \& Sports clinic to receive rehabilitation will be included in the study. Participants will be randomized into 2 groups. Resistant exercise with blood flow restrictive exercise (BFR-RE) will be applied to one group, and resistant exercise with isokinetic device (ID-RE) will be applied to the other group. An 8-week exercise protocol will be created for both groups and exercise training will be given twice a week. Demographic data form, Kineo Intelligent Load Isokinetic Device to measure muscle strength, tape measure to measure circumference, universal goniometer for joint range of motion, Illinois Agility Test for agility and quality of life; World Health Organization Quality of Life Scale-Short Form Turkish Version will be administered before exercise, at the 4th week and at the 8th week. The effectiveness of the applications for female football players and their advantages over each other will be examined. The 4-week and 8-week effects of 2 types of exercise will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-30
* Becoming a female football player
* Volunteering to participate in the study

Exclusion Criteria:

* Deep vein thrombosis
* Pregnancy
* Hypertension
* Anti-inflammatory use
* Unexplained chest pain
* Congenital heart disease
* Participants with a history of contraindications to exercise
* There is another study conducted at the same time as the study.