cyrilzakka/clinical-trials huggingface dataset:
Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer

This phase I trial tests a digital meditation for postoperative pain control after abdominal surgery for cancer. Mindfulness interventions such as guided meditation may improve pain control and decrease stress. Including a brief mindfulness intervention administered via test messages as part of postoperative care may improve pain severity, decrease opioid use, and improve patient responses to non-surgical treatments.

PRIMARY OBJECTIVES:

I. To investigate and define anticipated and unanticipated adverse events (AEs) related to a daily virtual mindfulness intervention delivered via short message service (SMS) text messaging and to test its safety in the postoperative period amongst patients with cancer.

II. To determine the feasibility and acceptability of a novel, brief mindfulness intervention delivered via SMS text messaging in the postoperative period amongst patients undergoing surgery for cancer.

III. To determine the feasibility and acceptability of an artificial intelligence platform to deliver and receive SMS text messages for the purpose of delivering pain assessment tools and collecting and storing pain-specific and patient reported outcomes.

OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

ARM II: Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years of age
* Open abdominal surgery for cancer
* Ownership of smartphone (iOS or Android operating systems) with SMS texting capabilities
* Ability to read
* Ability to understand the purposes and risk of the study and willingly give standard written informed consent for treatment established by each participating institution.

Exclusion Criteria:

* Patients with contraindications to abdominal surgery and/or general anesthesia
Thyroid Functions in Children With Congenital Heart Diseases

Thyroid hormone is critical for normal neurocognitive development in young infants, and even transient hypothyroidism can cause adverse neurodevelopmental outcomes. In a population of infants with CHD who already bear a high risk of long-term developmental delay, detection of hypothyroidism, even of a transient nature, may be even more consequential, and routine periodic monitoring of thyroid function may be necessary to reduce the risk of neurodevelopmental disabilities


Eligibility Criteria:
Inclusion Criteria:

* All children since birth up to age of 12 years old including both genders diagnosed to have CHD exposed to radiation, contrast or not.

Exclusion Criteria:

* above 12 years old
Mobility Exercises for Gait (MEG Neuroplasticity Project)

This study is directed at identifying a the neurophysiological changes seen in children with cerebral palsy (CP) after undergoing physical therapy. The specific aims of the study will: (1) determine the changes in the sensorimotor cortical activity after physical therapy, (2) determine the mobility, participation and muscular performance improvements after therapy, and (3) determine the changes in a child's participation in activities outside of the laboratory environment.

This study is directed at identifying a the neurophysiological changes seen in children with cerebral palsy (CP) after undergoing physical therapy. The specific aims of the study will: (1) determine the changes in the sensorimotor cortical activity after physical therapy, (2) determine the mobility, participation and muscular performance improvements after therapy, and (3) determine the changes in a child's participation in activities outside of the laboratory environment. The study consists of a cohort of children with CP that will undergo an action-perception training protocol, a cohort that will undergo a high velocity power training protocol and a cohort that will undergo body weight supported treadmill training. Participants will be between the ages of 9-18 years and have gross motor function classification score levels between I-III. All participants will complete final initial baseline measures of their brain activity, mobility, muscle performance, and participation activity outside of the laboratory. After completing these tests, the children will undergo the respective physical therapy protocols for 8-weeks (3 days a week). After the 8-weeks of therapy, both groups will repeat the same tests that were completed at baseline. Follow-up assessment will consist of a physical therapist scheduling a time to visit the family at their house and ask them questions about the child's participation in activities.

Eligibility Criteria:
Inclusion Criteria:

* Sustained a brain injury around the time of birth or a diagnosis of Cerebral Palsy
* Must be able walk without a wheelchair (GMFCS I-III)

Exclusion Criteria:

* Children dependent on a wheel chair for mobility
* Braces, permanent retainers, or metal in the head (creates artifact in the MEG)
* Orthopedic surgery within last 6 months
* Botulinum injections within the last 6 months
The Effect of Nandrolone Decanoate and Leucine on Muscle Loss

A decrease in muscle mass can have a profound impact on quality of life, as it can lead to decreased strength, insulin resistance, lower basal metabolic rate and obesity. With this study we investigate whether ingesting leucine or getting a ND injection will reduce the loss of muscle mass and strength.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men 18-35 years
* BMI between 18.5 and 30 kg/m2

Exclusion Criteria:

- (Family) history of thromboembolic events

* Smoking
* Recent surgery (within 6 months prior to the study)
* Performing progressive resistance training more than three times per week in the past year
* Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
* Current systemic use of corticosteroids, anabolic steroids, growth hormone, testosterone, nandrolone, protein supplements, immunosuppressants or insulin, blood sugar decreasing medication or EPO
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis)
* Use of anti-coagulants
* Pre-existing renal disease or those with a potential risk for renal dysfunction (diabetes, hypertension, reduced glomerular filtration rate)
* Liver disease
* Heart failure
* Migraine
* Allergy to nuts or soy
* High blood pressure (\>140 mmHg systolic and \>90 mmHg diastolic) In case of doubt, in- or exclusion of subject will be discussed with responsible physician or principal investigator.
A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension

The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent
* At least 18 years of age
* Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
* Best corrected-distance visual acuity score equivalent to 20/80 or better
* Stable visual field
* Central corneal thickness between 490 - 620 micrometers

Inclusion Criteria at the Randomization Visit:

* IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=4hr and T=8hr.
* Inter-eye IOP difference of ≤ 5.0 mmHg at T=0hr, T=4hr and T=8hr.
* IOP for each eye is ≤ 30 mmHg at T=0hr, T=4hr and T=8hr.

Key Exclusion Criteria:

* Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
* A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of a topical beta-blocker
* Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
* Cup-to-disc ratio of greater than 0.8
* Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy
* Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
* Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
* Past history of any incisional surgery for glaucoma at any time
* Past history of corneal refractive surgery
* Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
* Current participation in an investigational drug or device study or participation in such a study within 7 days of Screening
* Inability to adequately evaluate the retina
* Subjects who will require contact lens use during the study period.
* Subjects who currently have punctal occlusion
* Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication

The purpose of this study is to determine whether the general anesthesia immunosuppressive could effect hepatitis B Virus replication

The change of immune state can influence HBV replication or elimination, it has been reported that a certain degree of immunosuppression occured after general anesthesia. In this study we detect the cytotoxic T lymphocyte(CTL) count and activity, interferon-γ(IFN-γ) and HBV-DNA content form the HBV patient who will accept general anesthesia. Our purpose is to evaluate the influence of general anesthesia immunosuppressive on HBV replication. If the results show that HBV-DNA quantity increases, so the patients might be given anti-HBV drugs or immune enhancer; otherwise it is indicated the general anesthesia immunosuppressive don't influence HBV replication.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;
2. ability to compliance the research plan;
3. volunteered and signed for the study ;
4. HBsAg positive, no serious system disease (heart: New York Heart Association（NYHA） class Ⅰ - Ⅱ, lung: vital capacity（VC）% or maximal voluntary ventilation（MVV）%\>71, forced expiratory volume at one second（FEV1.0）%\>61, arterial oxygen saturation（SaO2）%\>94, arterial partial pressure of oxygen（PaO2）\>75 mmHg, arterial carbondioxide partial pressure（PaCO2）\<45mmHg, liver:child-pugh class A - B and kidney: chronic kidney disease（CKD）stage 1-3);
5. receive under general anesthesia (including gynecology, orthopedics,general surgery and urology department).

Exclusion Criteria:

1. ASA\>Ⅱ;
2. tumor patients
3. can't collaborate;
Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY.

Despite the advances in the treatment of acute cardiogenic pulmonary edema (ACPE), the readmissions rates and cardiovascular events remain very high. In this context, it is possible that other potential risk factors may influence the poor prognosis of the ACPE. One of these potential candidates is Obstructive Sleep Apnea(OSA). This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with ACPE. The primary outcome will be to evaluate the impact of CPAP on the recurrence of ACPE in the 1-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive acute Cardiogenic Pulmonary Edema
* Moderate to Severe OSA

Exclusion Criteria:

* Professional drivers
* Pregnancy
* Non-Cardiogenic Pulmonary edema
* Terminal cancer
Effects of Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase

The purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase.


Eligibility Criteria:
Inclusion Criteria:

* Malignant Tumor
* Medical Treatment in the Center for Pediatrics, Hematology, Oncology and Hemostaseology Mainz (Germany)
* \> 3 years
* Signed Informed Consent

Exclusion Criteria:

* Functional and/or cognitive limitations which limit performance during training
* Orthopedic condition which hinders to adequately participate in exercise training
* Heart failure (NYHA III-IV)
* Partial or global respiratory failure
* Symptomatic coronary disease
* Serious therapy-refractory hypertonia
* Sustainable thrombocytopenia \<10.000/µl, f. ex. therapy-refractory autoimmune thrombocytopenia
* Hereditary or acquired thrombocytopenia or coagulation disturbance
* Uncontrolled cerebral spasm
* CNS metastases
* Medical or psychological condition which does in the doctors opinion not allow participation in sport activity
Multidetector Computed Tomography (MDCT) Tailored Protocol

Collection of data from different sites regardless of whether they use standard or tailored protocols for the application of high concentration iodinated contrast agents to assess if the individually patient-adapted protocols result in a similar diagnostic image quality.

To record technical information and compare image quality regarding routine MDCT procedures with contrast administration using a tailored contrast injection and radiation dose protocol. The hypotheses are that the tailored protocols lead to a lower applied mean radiation dose compared to the use of standard protocols and will provide a more standardized contrast dose per patient size without impairing diagnostic quality.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Scheduled to undergo contrast enhanced MDCT of the abdomen, liver, aorta, or chest
* Provides written informed consent

Exclusion Criteria:

* Previously enrolled and completed the study
* Known allergy to iodinated contrast media
* Pregnancy or lactation
* Clinically unsuitable for the study
Effects of a Wearable Device and Social Media-Based Intervention on Physical Activity and Sleep Quality in Adults

The goal of this randomized controlled trial is to examine whether the use of a wearable device and social media based intention increases physical activity and enhance sleep quality among adults.

The present study aims to study sedentary breaks and sleep quality in Taiwanese adults.

This is a three-arm randomized controlled trial, exploring the effects of a one-month wearable device-based intervention (Garmin tracker) in increasing physical activity and improving sleep quality in adults (Target n = 75 ). The one-month follow-up assessment will be conducted to examine the remaining effects of the intervention.

The main questions it aims to answer are:

Does using a wearable device improve physical activity and improve sleep quality among adults?

Does the inclusion of motivational support provided via social media promote even greater effects in increasing physical activity and improvements in sleep quality?

Researchers will compare groups wearing a device and receiving motivational support via social media (intervention group 1) or wearing a device but without support (intervention 2) to a control condition (participants who do not wear a device and do not receive support) to see whether a wearable device could increase physical activity and improve sleep.

Eligibility Criteria:
Inclusion Criteria:

* Those who have not used a wearable-device before.

Exclusion Criteria:

-
Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients

A multi-center, open-label, phase Ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r/r DLBCL who have received 2 or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy and having failed to or are not candidates for ASCT. The study will consist of 2 parts: dose timing selection part and expansion part.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed DLBCL per local histopathology assessment.
* Relapsed or refractory disease after having recieved 2 or more lines of systemic therapy, including anti-CD20 and anthracycline based chemotherapy, and either having progressed after (or relapsed after) ASCT, or being not candidates for or not consenting to ASCT.
* Measurable disease at time of enrollment
* ECOG performance status that is either 0 or 1 at screening.

Exclusion Criteria:

* Patients with Richter's transformation, and Burkitt lymphoma, and primary DLBCL of CNS.
* Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy.
* Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was \>4 weeks before enrollment.
* Prior allogeneic HSCT.
* Unstable angina and/or myocardial infarction and/or coronary artery bypass graft (CABG), or stroke within 6 months prior to screening, and/or impaired cardiac function or clinically significant cardiac disease
* Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, other immune checkpoint inhibitors.
* History of interstitial lung disease or (non-infectious) pneumonitis that required oral or intravenous steroids (other than COPD exacerbation) or current pneumonitis.

Other protocol-defined inclusion/exclusion criteria may apply.
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis

The trial will include patients diagnosed with left-side Infective Endocarditis according to the modified Duke criteria, with ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery

The patients will be randomized in two arms, one with oral antibiotic therapy and the other one with outpatient parenteral therapy

This trial aims to demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT), to improve the quality of life of infective endocarditis (IE) patients, and to reduce the cost of the intervention without increasing morbidity and mortality rates

Eligibility Criteria:
Inclusion Criteria:

* Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group.
* Male or female 18 years old or older.
* 10 days or more of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after value surgery.
* Temperature inferior to 38ºC for more than two days. 5. C-reactive protein dropped to \<25% of peak value or \<20 mg/l, and white blood cell count \<15x10\^9/l during antibiotic treatment
* Transthoracic / transesophageal echocardiography performed within 48 hours of randomization

Exclusion Criteria:

* Body mass index \>40
* Concomitant infection requiring intravenous antibiotic therapy
* Inability to give informed consent to participation
* Suspicion of reduced absorption of oral treatment due to abdominal disorder
* Microorganisms with no oral combinations for treatment (two active antibiotics of different families)
* Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy
* No family or appropriate home support
* Reduced compliance
* Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period
* Women in lactancy period
Safety Study of Surgical Technique to Treat Acute Dorsal Trans-Scaphoid Perilunate Dislocations

The purpose of this study is to determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations.

Open reduction and internal fixation is an effective method of treating acute trans-scaphoid perilunate dislocations. We study a new surgical technique that allows for early wrist excises postoperatively. We compare this technique to Inoue et al. 's techniques affect the objective and subjective outcomes. We also compared the long-term outcomes of these two procedures performed in similar patient groups.Although both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture, the technique using in group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.

Eligibility Criteria:
Inclusion Criteria:

* Clinical treatment of acute trans-scaphoid perilunate dislocations
* Must have open reduction and internal fixation

Exclusion Criteria:

* Patients whose age under 18 years
* Associated with severe crush, avulsion, or opened injury
Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies

The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies.


Eligibility Criteria:
INCLUSION CRITERIA:

Phase 1b

* Histologically confirmed diagnosis of a hematologic malignancy, excluding patients with acute leukemia or MDS.
* Relapsed after standard therapy for their malignancy and considered to be an appropriate candidate for a Phase 1 clinical study by their treating physician.

Phase 2

* Multiple myeloma with measurable disease
* Waldenström macroglobulinemia with symptomatic relapse
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

Ethical/Other

* Patients must sign a written informed consent form in accordance with federal, local, and institutional guidelines.
* Female patients of childbearing potential must have a negative serum or urine pregnancy test and agree to use effective contraception. Male patients must use an effective barrier method of contraception.

EXCLUSION CRITERIA:

* Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy intended to treat underlying malignancy, within 3 weeks prior to first dose or 6 weeks for antibody therapy.
* Radiation therapy within 3 weeks prior to first dose. Radioimmunotherapy within 8 weeks prior to first dose. Localized radiation therapy within 1 week prior to first dose.
* Immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required).
* Prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-vs-host disease (GvHD; as defined in Filipovich 2005).
* Evidence of central nervous system (CNS) lymphoma.
* Prior treatment with carfilzomib unless in the phase 2.
* Major surgery within 3 weeks prior to first dose.
* Symptomatic Congestive heart failure, ischemia, conduction abnormalities, or myocardial infarction within 6 months.
* Acute active infection requiring systemic antibiotics, antivirals, or antifungals.
* Known or suspected human immunodeficiency virus (HIV) infection or patients who are HIV seropositive.
* Active hepatitis A, B, or C infection.
* Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose.
* Patients with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis.
* History of previous clinically significant GI bleed in the last 6 months prior to first dose.
* Female patients who are pregnant or lactating.