cyrilzakka/clinical-trials huggingface dataset:
Resiliency Among Older Adults Receiving Lung Cancer Treatment

This trial studies how well physical therapy and progressive muscle relaxation works in improving physical performance and mood in older patients with stage IIIA-B or IV lung cancer who are undergoing treatment. Improving physical performance and mood may help older patients maintain an independent lifestyle by helping to improve their resilience, the ability to bounce back to normal functioning after a stressor or intervening health event such as treatment or disease progression. Giving physical therapy and progressive muscle relaxation may work in improving symptoms and quality of life in patients with lung cancer.

PRIMARY OBJECTIVES:

I. To assess the feasibility of a novel, weekly supervised virtual health-assisted physical therapy plus relaxation intervention delivered to older adults with advanced thoracic malignancy (N=20).

OUTLINE:

Patients participate physical therapy sessions consisting of cardiovascular and resistance training exercises in person or online and also undergo progressive muscle relaxation sessions once weekly for up to 12 weeks.

After completion of study therapy, patients are followed up at 24 weeks, and then periodically for up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with advanced lung cancer: unresectable stage IIIA, IIIB, or stage IV non-small cell lung cancer (NSCLC) or extensive stage small cell lung cancer (SCLC).
* Intent to receive treatment from the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic.
* Willingness to participate and adhere to the study intervention program.
* Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means).

Exclusion Criteria:

* Prisoners are excluded from participation.
* There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, prior cancer diagnoses, presence of comorbidities or brain metastases.
OptiMoM Kindergarten Study

In Canada, the leading cause of long-term disability in children is being born at very low birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant care. Mother's milk is the optimal way to feed VLBW infants; however, many need a supplement of donor milk or preterm formula as not enough mother's milk is available. As the ideal supplement for prolonged feeding and its long-term effects is currently unknown, this study is a prospective follow up of VLBW infants who in hospital were fed: donor milk or preterm formula and/or mother's milk. Areas of development to be assessed include: cognition, language, motor skills, brain structure/function, and body composition. A DNA biorepository will also be created.


Eligibility Criteria:
Inclusion Criteria:

* Children who were enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).
Shared Decision-Making and Dialysis Choice

The SDM-DC intervention is designed for patients with kidney failure who must make a decision regarding type of dialysis: haemodialysis or peritoneal dialysis. SDM-DC consists of patient and his or her relative(s) being given a patient decision aid called 'Dialysis choice' and booked for meetings with a dialysis coordinator.

The dialysis coordinators were trained in the why, what and how in relation to SDM-DC and to deliver the intervention by tailoring to patients' needs and using three different communication skills: mirroring, active listening and value clarification. The patient decision aid was designed to be utilised during and between the SDM-DC meetings. The patient decision aid is in paper format and consists of a set of tools: a decision map, an overview of uremic symptoms, an overview of options, and the Ottawa Personal Decision Guide. More specifically, the patient decision aid makes explicit the dialysis decision, describes options, benefits and harms using the best available evidence, and intends to help patients clarify their values by indicating the importance of the benefits and harms out of scale from (0) to (5). Four videos with personal stories were available to be shown and discussed at the meetings if the patient preferred to see the reason why another patient has chosen a specific option. Each video showed one option with a patient telling why he/she chose that option, and how he/she weighed the advantages and disadvantages.

Eligibility Criteria:
Inclusion Criteria:

* Estimated glomerular filtration rate below 20 ml/min
* A clinical judgement made by the contact nurse and the contact physician

Exclusion Criteria:

* Conservative care
* A set date for a transplantation with a living donor
* Not able to participate due to cognitive impairment
Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS)

This is a multi-centre, registry-based study whose primary objective is to evaluate the effect of treatment for sleep apnoea syndrome (SAS) on the number of syncope/malaise episodes in a population suffering from both idiopathic, recurrent vasovagal syncope/malaises and SAS.

Treatment for sleep apnoea syndrome includes continuous positive airway pressure (CPAP) or a mandibular advancement device (MAD). Additional routine follow-up includes 24 hour holter monitoring on a yearly basis, polysomnography on a yearly basis, multiple sleep latency tests, table tilt tests.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnoea syndrome (\>15 respiratory micro awakenings per hour of sleep) with an indication for treatment
* Recurring vasovagal syncope episodes defined as follows: at least three vasovagal syncopes during the last two years - OR- symptoms of orthostatic intolerance occurring in the last 6 months (Symptoms are triggered by orthostatism and can include malaises without loss of consciousness, asthenia, dizziness, visual disturbances, tinnitus, palpitations, headache, limitations of physical activity)

Exclusion Criteria:

* Pathology that may explain syncope symptoms
* Cardiopathy
* Known disautonomia
* Hypotension of known origin
* Adrenal insufficiency
* Thyroid disorder
* History of sudden death in a first degree family member
A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance

This study is being conducted to evaluate the safety, tolerability and early efficacy of IV TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are admitted to the intensive care require mechanical ventilation, and are intolerant to enteral feeding.


Eligibility Criteria:
Inclusion Criteria:

* Intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study
* Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV measurement ≥250 mL within the 24 hours before randomization

Exclusion Criteria:

* History of diabetic or idiopathic gastroparesis
* Screening blood glucose \>15 mmol/L (270 mg/dL) while receiving insulin
* Impaired renal function, as defined by estimated glomerular filtration rate (eGFR) \<30 mL/min, as determined by the Cockcroft-Gault formula -Bilirubin concentration in blood \>2 times the upper limit of normal
* ALT or AST \>3 times upper limit of normal
* Alkaline phosphatase \>2 times upper limit of normal
* Contraindication to enteral feeding
* Opioid or other drug overdose as the primary reason for admission to Intensive Care Unit (ICU)
* Receipt of a drug that can be used as a gastric prokinetic agent
* Receipt of agents known to directly influence the 5 HT4/acetylcholine prokinetic mechanism
Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.

A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease

Eligibility Criteria:
Inclusion Criteria:

* Documented stable CAD fulfilling any of the following, and taking 81mg ASA daily treatment:
* Females must be post menopausal for at least one year or surgically sterile for at least 6 months and negative urine pregnancy test
* Self-identified as American Indian
* Genetic Inclusion Criteria: must sign the informed consent for genetic and biological sample banking.

Exclusion Criteria:

* Any indication for oral anticoagulant or dual antiplatelet treatment
* Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days and during study treatment and during:
* Increased bleeding risk including:
* Diabetic patients with HbAlC \> 10% at screening
* Contraindication to clopidogrel, ASA, or ticagrelor - A history of alcohol and/or substance abuse that could interfere with conduct of the trial
* Patients requiring dialysis
* Patients scheduled for revascularization (e.g., PCI, CABG) during the study period
* Any acute or chronic unstable condition in the past 30 days
* Known active or recurrent hepatic disorder
* Patients who had ACS or stent placed within 12 months of screening
* History of Uric Acid nephropathy
Observational Study of Angiographic Coregistered Optical Coherence Tomography in Patients Undergoing PCI

To define and evaluate the impact of angiographic coregistered OCT on physicians decision-making through prospective data collection in PCI procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patient provides signed written informed consent before any study-specific procedure.
* Patients suffer from coronary artery disease (CAD) including at least one angiographically significant (\>70% visual estimation) stenosis present in a native coronary artery with planned PCI.

Exclusion Criteria:

* Subjects with emergent PCI or in cardiogenic shock.
* Subjects with target left main (LM) lesion, with restenosis or stent thrombosis in the target vessel or with aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
* Extreme angulation (\> 90°) or excessive tortuosity (\> two 45° angles) proximal to or within the target lesion.
* Known renal insufficiency (examples being but not limited to estimated glomerular Filtration rate (eGFR) \< 50 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL or on dialysis).
* Any other medical condition that in the opinion of the investigator will interfere with patients safety or study results.
* Currently participating in another clinical study that interferes with study results.
* Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
* Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy
Carnitine Supplementation and Skeletal Muscle Function

Research project objectives The primary aim of the current research project is to use carnitine supplementation as the anti-inflammatory intervention for exploring the relationship between inflammation and associated with aging reduction of skeletal muscle mass.

Hypothesis The carnitine supplementation modulates the blood cytokines concentration. Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated with aging

Volunteers over 65 years old (n=40) are supplemented either with carnitine or placebo for 24 weeks. Before the start, in the mid-point, and after finishing the supplementation the following primary outputs variables are performed: body composition analysis (InBody720), maximal isokinetic knee extensor peak torque (Biodex System 4 Pro), blood cytokines and carnitine concentration, blood lipid profile.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with no history of gastrointestinal disorders, cardiovascular disease or hypertension.

Exclusion Criteria:

* Subjects having any illnesses and a history of gastrointestinal disorder, cardiovascular disease, hypertension, liver and renal disease, diabetes, cancer, alcoholism or other metabolic diseases.
African American Community Health Project on Cardiovascular Disease

The investigators seek to demonstrate that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of cardiovascular disease in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease (CVD).

Cardiovascular disease causes significant morbidity and mortality in the African American community. Among African Americans adults almost 1/3 have hypertension, 1/10 have heart disease, 1/20 have coronary heart disease, and 1/30 have had a stroke. Compared to their Caucasian American counterparts, African Americans are 3 times more times as likely to die from cardiovascular diseases than Caucasians, 1.5 times more likely to die from heart failure, and 1.8 times more likely to die from stroke. In addition, both lower socioeconomic position and minority race/ethnicity are associated with poorer health and shortened survival. These alarming statistics highlight the health disparities in the African American community. In our study, the investigators propose that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of CVD in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* African American adults \> 18 years old
Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection

This monocentric early feasibility first in human study is intended to evaluate safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection.

In consequence the data should also be taken to adapt technical features according to the findings. The study results will be utilized to design and to calculate the sample size for future pivotal studies after finalizing this study and to adapt the technical features of the system and/ or device. In the future pivotal study, the effectiveness of method and the reduction in R1 resection rate will be assessed with the final goal to provide continuous or real-time information about the tissue type that is currently cut.

The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device.

After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. During the second visit (V2) they will receive the treatment procedure with the investigational medical device (IMD). The follow up visit (V3) will be performed up to 7 days after the treatment procedure at the day of discharge from the hospital.


Eligibility Criteria:
Inclusion Criteria:

1. Female patient with primary invasive breast cancer (NST or NST with DCIS component, including endocrine pretreatment according to standard of care therapy at the study site)
2. Solid tumor size ≥ 15 mm at screening, on sonography imaging
3. Breast conserving surgery
4. ≥ 18 years of age
5. Ability to provide written informed consent

Exclusion Criteria:

1. Neoadjuvant chemotherapy
2. Bilateral breast conserving surgery
3. Invasive lobular carcinoma, DCIS, LCIS
4. Suspicion of extensive DCIS component of NST tumor
5. Diagnosis of recurrent breast cancer
6. Previous radiotherapy
7. Patient is pregnant or lactating
8. Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator
9. According to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair

Iliac crest autogenous bone graft is accepted as the most effective method for secondary alveolar cleft repair. However this method is associated with complications. As an alternative, mesenchymal stem cells associated with biomaterials have been used for the rehabilitation of the alveolar bone cleft of patients with cleft lip and palate. This is a RCT comparing mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials versus iliac crest autogenous bone graft for secondary alveolar cleft repair.


Eligibility Criteria:
Inclusion Criteria:

* non syndromic unilateral cleft lip and palate;
* age between 7 and 12 years;
* to have the jaw aligned and ready to receive the graft.

Exclusion Criteria:

* previous surgery to correct the alveolar cleft;
* have the canine erupted before grafting;
* incomplete orthodontic treatment;
* incomplete CT scan documentation.
Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)

The purpose of this study is to determine whether etoricoxib, flavoxate, both are effective in the treatment postoperative pain after TURP.

The research hypothesis:

There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.

Postoperative pain is still a significant problem for surgical patients. Conventional use of narcotics for postoperative pain relief is not without serious side effects such as respiratory depression and sedation.There are other alternatives for postoperative analgesia as NSAIDs especially COX2-inhibitors. For some specific operation such as TURP which Foley's catheter needed to be retained for a few days,urinary anti spasmodics may help the patients to be more comfortable.

Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Male patient ASA physical status I-III.
2. Scheduled for an elective TURP.
3. Body weight \> or = 50 kg
4. Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

1. History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
2. Known hypersensitivity to morphine.
3. History of hepatic dysfunction.
4. Creatinine clearance \< 30ml/min.
5. History of bleeding tendency.
6. History of gastrointestinal bleeding or active peptic ulcer.
7. Known case of inflammatory bowel disease.
8. Patient with severe heart failure.
9. History of coronary artery disease or cerebrovascular disease.
Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis


Eligibility Criteria:
Inclusion Criteria:

1. who completed the full study period in the main ADORE study (FAB122-CT-2001);
2. whom the investigator has no concern and judges tolerable for initiating or continuing treatment with FAB122 from a risk and benefit point of view;
3. a female subject should not be able to become pregnant up to 30 days after the last dose of FAB122 and needs to meet at least one of the following criteria:

   * female who is of reproductive potential and has a negative pregnancy test at baseline and is non-lactating.
   * female subject who is not of reproductive potential is eligible without requiring the use of contraception
4. a male patient must:

   * agree he will not donate sperm during the period he will be using FAB122, AND use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential

Exclusion Criteria:

1. Patient who has a medical condition or personal circumstances which, in the opinion of the investigator, will make initiation or continuation of treatment with FAB122 not tolerable for them from a risk and benefit point of view.
2. Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons.
3. Patient who has received any other investigational drug within the period between last visit of the main study and first visit of the extension study
A Study of Galcanezumab in Participants With Chronic Cluster Headache

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a history of chronic cluster headache occurring without a remission period, or with remissions lasting \<1 month, for at least 1 year.
* Participants are able to distinguish cluster headache attacks from other headaches.

Exclusion Criteria:

* Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
* Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
* Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
* A history of migraine variants that could implicate or could be confused with ischemia.
* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
* A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
* Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
* Women who are pregnant or nursing.