cyrilzakka/clinical-trials huggingface dataset:
Lullaby and Classic Music's Effect on Vital Findings and Comfort

In the study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels.

In the literature, there are many studies on prematurity pain and its relief. Although the vital signs and comfort levels of infants were examined in many applications for infants hospitalized in the neonatal intensive care unit, no study was found in which the cerebral oxygenation levels of infants were evaluated by NIRS by listening to lullabies and classical music to premature infants. There is no study in the literature examining cerebral oxygenation, vital signs and comfort parameters together during orogastric tube feeding, which is frequently used in preterm infants. For this reason, in this study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels. It is thought that the study will present new data to the literature and will lead many researches.

Eligibility Criteria:
Inclusion Criteria:

* Being at 28-34 weeks of gestation,
* Stability (in terms of cerebral oxygenation, pain and vital signs) during enrollment,
* Not having any additional diagnosis other than the diagnosis of prematurity,
* Indication of bolus feeding with an orogastric tube,

Exclusion Criteria:

* Congenital anomaly in the baby
* Diagnosed hearing impairment in the baby
* Having a history of an invasive procedure (such as a surgical operation) that will disrupt the baby's long-term comfort and cause pain
* The baby is receiving oxygen therapy or the baby is on mechanical ventilation
* Any history of disease affecting cerebral oxygenation (such as intraventricular hemorrhage, neonatal convulsions).
Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy

The objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen).

The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been established. This 3-year follow-up study will provide additional data to gain understanding of the safety of the investigational agent. This study is designed to determine the safety of a single intra-articular injection of 50 million donor-derived hMSCs or 150 million donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study, Protocol No. 550.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have received an injection in Protocol No. 550
* Subject must have completed the 6-month and final 2-year visit in Protocol No. 550
* Subject must provide written informed consent for entry into the extension study
* Subject must provide authorization for use and disclosure of protected health information for entry into the extension study
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fed Conditions

The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.

An open label, balanced, randomized, two-treatment, two-period, two-way crossover oral bioequivalence' study of Atorvastatin Calcium 80 mg Tablets of Dr. Reddy's and Lipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals in healthy adult, human subjects under fed conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 18 and 45 years (both inclusive).
2. Subjects' weight within normal range according to normal values for Body Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.
3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations (Annexure IIIa) within the clinically acceptable reference range (Annexure IIIb).
4. Subjects having normal 12-lead electrocardiogram (ECG).
5. Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 0 1.
6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
7. Subjects having negative alcohol breath test.
8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria:

Subjects will be excluded from the study, if they meet any of the following criteria:

1. Hypersensitivity to Atorvastatin or related class of drugs.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
4. History or presence of significant alcoholism or drug abuse in the past one year.
5. History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
6. History or presence of asthma, urticaria or other significant allergic reactions.
7. History or presence of significant gastric andlor duodenal ulceration.
8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
9. History or presence of cancer.
10. Difficulty with donating blood.
11. Difficulty in swallowing solids like tablets or capsules.
12. Use of any prescribed or OTC medication during last two weeks prior to dosing in period 0 1.
13. Major illness during 3 months before screening.
14. Participation in a drug research study within past 3 months.
15. Donation of blood in the past 3 months before screening.
16. Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol for within 48 hours prior to dosing.
17. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
18. History or presence of significant easy bruising or bleeding.
19. History or presence of significant recent trauma.
Gastrointestinal Stromal Tumors (GIST) Registry

The goal of this observational research study is to establish a registry of information regarding how different physicians treat and manage patients with gastrointestinal stromal tumors (GISTs).

Objectives:

1. To describe variation in management of patients with GIST, overall and by patient and provider characteristics.
2. To provide participating physicians with information regarding management of their patients with GIST compared to the aggregate experience of all physicians participating in the Registry.

The Registry, which is Internet based, is intended to collect information about current practices in the management of GIST without making any specific change to the standard of care as decided by each patient's treating physician.

If you agree to participate in this study, your doctor will provide information to a data registry about your physical and clinical traits, the past and current medical care you have received to treat your GIST, and clinically-related, economically-related, and health-related quality of life information. About 200 doctors will provide information on their patients for the Registry. Your doctor will collect this information when you first join the Registry and at each regularly scheduled visit you make to your doctor's office. The information collection will continue for as long as you and your doctor feel it is appropriate. The information that is entered into the Registry will remain there indefinitely. It is hoped that this sharing of information will lead to a better understanding of how to best treat patients with GIST.

You and your doctor will decide what treatment you will receive. Because this Registry is only to observe actual medical practice, it does not require you to receive any particular treatment.

Only your doctor and people who will help your doctor collect the information for this Registry will know which information submitted to the Registry belongs to you. Data will be tracked in the Registry using only ID numbers and patient initials. The information submitted on the Registry data collection forms will not be associated with a specific patient's identity. Separately, you will be asked to provide your name, place of birth, and Social Security number. This information will not be entered into the Registry databases and will only be used if it is necessary to perform a search should you become lost to follow up. If you do not want to provide your Social Security number you may still be enrolled in the Registry.

This is an investigational study. About 100 patients from M. D. Anderson will be entered into the Registry. In all, about 1800 patients will be registered. The Registry will be active for at least 7 years.

Eligibility Criteria:
Inclusion Criteria:

1. All patients who have been diagnosed with GIST are eligible for enrollment.

Exclusion Criteria:

1. Patients with a histologic diagnosis other than gastrointestinal stromal tumor (GIST).
Investigation of Efficacy and Outcome of a New Medical Device for Treatment of Migraine

The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks, and presence of a preventive effect two months post treatment. Another purpose is to investigate if and how this treatment affects manifestations of the autonomic nervous system activity.


Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects, in otherwise good health, 20 to 55 years of age
* Subjects who meet the ICHD-2 (2nd Edition of The International Headache Classification) criteria for migraine headache
* Subjects with a minimum of 1 migraine attack per month
* Attack duration of 4 to 72 hours
* Normal attack intensity of at least 4 on a 0-10 VAS-scale

Exclusion Criteria:

* Completed heart surgery
* Cardiovascular diseases
* Vascular damages on neck vessels
* Diseases other than migraine of the CNS
* Severe disease of vital body organs
* Severe psychiatric disorders
* More than 6 migraine attacks per month
Bracing to Treat Knee Osteoarthritis in Elderly

Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population. Knee braces are often used to prevent common problems in knees during daily activities. The purpose of these devices is to decrease pain and improve functionality. In the literature some studies have tested the effectiveness of unloader brace for valgus or varus. However, the braces most used in the investigators' clinical setting and the less costly ones have not been described in quality studies in the literature. There are only few studies on this subject and they are methodologically inadequate. There are no studies that compared the effectiveness between the knee brace with metal hinges (no alignment) and knee brace without metal hinges. Objective: To evaluate the effectiveness of knee braces on pain, function and quality of life in the elderly with knee OA. Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric scale were included. Of the 222 patients screened, 120 met the eligibility criteria and were randomized to the groups: without metal hinges, with metal hinges or control group. The groups without and with metal hinges received knee brace and were instructed to use it in daily activities, every day, during three months. Assessment for pain (NPS), function (WOMAC and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180 days by a blinded assessor.


Eligibility Criteria:
Inclusion Criteria:

* pain in numerical pain scale between 3 and 7cm;
* Knee ligamentous instability

Exclusion Criteria:

* fibromyalgia and neurologic disease;
* knee or hip replacement
* surgery scheduled in the following 6 months
* start physical activity or received joint injection in the past three months
* need to use walking aids or brace in knee
Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease

The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).


Eligibility Criteria:
Inclusion Criteria:

Clinical

* Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
* Discopathy refractory to conservative treatment (drugs, physical therapy.)
* Evolution greater than or equal to 6 months. Radiological
* Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
* NMR: grades IV and V of Pfirman.

Exclusion Criteria:

* Rejection of surgical treatment.
* Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
* Immunosuppressive treatment.
* Congenital or acquired anatomical abnormality that prevents the surgical procedure.
* Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
* High surgical risk (ASA\> IV), or contraindication to anesthesia.
Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.

This study is proposed to explore the effect of systemic Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.

After foot and ankle surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare different doses of perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic.

The investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously covers the need for good pain relief and fast recovery postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* children scheduled for hand/wrist surgery
* body weight \> 5kg

Exclusion Criteria:

* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use
ADC-1013 First-in-Human Study

The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors.


Eligibility Criteria:
Major Inclusion Criteria:

* Diagnosis of advanced solid tumor disease
* Performance status of 0-1 on the ECOG scale
* Life expectancy of at least 3 months

Major Exclusion Criteria:

* Organ transplant recipient
* Autoimmune disorder
* Other malignancy (except localized prostate cancer, adequately treated basal skin cancer or carcinoma in-situ of the cervix)
Evaluating Biobanking Educational Tools

The purpose of this study is to evaluate English and Spanish language educational materials that inform the community about a type of cancer research that involves the collection, storage, and processing of biospecimens. Part A of this study involved creating surveys about biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin to evaluate education materials about biospecimen donation and research.

Phase II consists of two independent randomized controlled trials. Each trial is being conducted independently to test English and Spanish language materials (75 subjects each).

The project addresses gaps in information by developing and validating English and Spanish language instruments to measure knowledge of and attitudes towards biospecimen donation and banking, as well as intention to donate biospecimens to a biobank (Part A). Once developed, the instruments will be used to evaluate biobanking educational priming tools by conducting two independent RCTs. Wherein English educational materials will be tested with 75 participants recruited from an urban clinic, and Spanish educational materials will be tested with 75 participant recruited form a rural community health center network. For each RCT following baseline assessment, participants will be randomized to either: 1) educational priming tools (DVD and booklet) developed by the Tampa Bay Community Cancer Network (TBCCN); or 2) an NCI-developed brochure entitled "Providing Your Tissue for Research: What You Need to Know." Seven to 28 days later participants will be given a telephone follow up interview.

Eligibility Criteria:
English Language RCT Inclusion Criteria:

* scheduled for an appointment at Lifetime Cancer Screening (LCS)
* able to read and speak English
* able to provide informed consent

Spanish Language RCT Inclusion Criteria:

* receiving care at a participating clinic from the Suncoast Community Health Centers network
* able to read and speak Spanish
* able to provide informed consent

Exclusion Criteria:

* previously diagnosed with cancer
* previously participated in a biobank
* participated in another TBCCN-related study entitled "community perceptions on biobanking"
Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers

The Polyflux HD-C4 (Gambro Renal Products) is a new dialyzer based on the existing Polyflux H membrane and dialyzer technology, but which achieves a performance comparable to Polyflux 210H in a significantly smaller device.

The objectives of this study are:

1. To compare and contrast small and large molecule removal by the Polyflux HD-C4 and Polyflux 210H dialyzers under conditions of routine hemodialysis; and,
2. To compare and contrast the ease of use of the Polyflux HD-C4 dialyzer with that of the Polyflux 210H under conditions of routine clinical use for hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Stable hemodialysis prescription using Polyflux 210H or Polyflux 21R for at least 2 months prior to study enrollment
* Dialyzing through a native fistula or Gore-Tex graft.
* Blood access must be able to provide a blood flow rate of 400 ml/min.

Exclusion Criteria:

* Non-compliance with dialysis
* Hematocrit less than 28%
* Active Infection
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with relapsed or refractory small cell lung cancer.

This study will be conducted in 2 parts. Part 1 will evaluate two treatment arms, each with a different KRT-232 dose. Part 2 will continue the evaluation of the selected treatment arms from Part 1.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT
* Disease must be measurable per RECIST Version 1.1
* Evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse.
* Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.
* ECOG ≤ 2

Exclusion Criteria:

* Symptomatic or uncontrolled central nervous system (CNS) metastases.
* Prior treatment with MDM2 inhibitors
* Chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment
* Grade 2 or higher QTc prolongation (\> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
* History of major organ transplant
Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)

The NIMH s RFA-Suicide Prevention in Emergency Medicine Departments recognizes the emergency department (ED) as an important setting to increase suicide detection and prevention efforts but observes that evidence-based practice guidelines do not exist. In response, we have designed the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) trial. The ED-SAFE study will be conducted using a quasi-experimental design appropriate for studying systems-based change. The study consists of two components (Screening Outcome \& Intervention Evaluation) and three phases of data collection: Treatment as Usual, Screening Alone, and Intervention. During each phase, 480 suicidal patients (1,440 total) will be enrolled and followed using multiple methods for 12 months.

The Screening Outcome Component

The Screening Outcome component will use data collected during the Treatment as Usual and Screening Alone phases. Consistent with systems-change principles, when universal screening is incorporated during the Screening Alone phase, it will be completed by the primary nurse as part of routine care. Primarily, it will focus on testing a practical approach to screen ED patients for suicidal ideation and behavior and will assess its impact on suicide detection, process outcomes, and suicide behaviors.

Intervention Evaluation Component

The Intervention Evaluation component will use data from the Treatment as Usual, Screening Alone, and Intervention Phases. During the Intervention phase, each ED will implement a multi-component, systems-based Intervention called the Safety Assessment and Follow-up Telephone Intervention (SAFTI). The SAFTI will combine elements of: (a) safety planning administered by nursing staff in the ED, and (b) Coping Long Term with Active Suicide Program (CLASP)-ED, a series of up to 7 semi-structured telephone advising calls to the patient and 4 to the significant other over the 12 months after the ED visit. Safety planning will be implemented universally to all suicidal patients, regardless of whether they are ultimately enrolled into the trial, as part of a comprehensive suicide management protocol (e.g., it is a systems-based change). However, for practical and budgetary considerations, the CLASP-ED telephone advising calls will be administered only to participants enrolled into the study.

Our overarching hypotheses will be tested using a combination of the Screening Outcome component and the Intervention Evaluation Component. We predict that screening will improve detection of suicidal ideation, and the intervention will enhance the quality of care and reduce suicide outcomes.

see summary above

Eligibility Criteria:
Inclusion Criteria:

* Over 18,
* Entering care at a hospital ED,
* Documented thoughts or behaviors related to self-harm.

Exclusion Criteria:

* No phone or permanent address,
* Does not speak English or Spanish.
Single Dose Bronchodilatory Study in Asthma

Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma for at least 5 years
* FEV1 of 50-85% predicted
* Reversible airway obstruction

Exclusion Criteria:

* Pregnant/nursing females
* Liver function tests greater than upper limit of normal