cyrilzakka/clinical-trials huggingface dataset:
Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure

Funnel chest deformation is a painful procedure, which requires high doses and long time used of opioids. It makes difficult introduction of ERAS protocol. Intraoperative cryolesia of intercostal nerves serves great relief of pain after this procedures. However ablation of the nerves needs 12-24 hours to achieve effects. During this time the high doses of opioids are needed. It causes side effects (sedation makes rehabilitation difficult). On the other hand, percutaneus cryoablation performed 12-24 hours before Nuss procedure needs repeated general anaesthesia. The investigators hypothesed that regional analgesia (erector spine plain block) performed just before intraopertive cryolesia may cover time to full cryolesia effect.

Severe pain in the post-Nuss procedure needs the use of many analgesic drugs, including opioids. It may cause adverse side effects and difficulties with rehabilitation. Moreover, it increases the risk of complications and prolonged hospitalisation. Cryoanalgesia as a part of multimodal analgesia offers better analgesia than single regional techiques with drugs and fasilitate introduction of the enhanced recovery after surgery (ERAS) protocol. However ablation of the nerves needs 12-24 hours to achieve effects. Regional analgesia (erector spine plain block) performed just before intraopertive cryolesia may cover time to full cryolesia effect.

This Before - After Study is a single institution pilot study designed to compare intraoperative cryolesia alone (control group) with the intervention group (cryolesia and bilateral erector spine plane block). It is designed for better management of acute pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method. Control group received standard care with cryolesia using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited) and multimodal analgesia according the current guidelines. The intervention group received all of the above and regional analgesia (erector spine plain block, ESP block).

The aims of the study were the assessment the effectiveness of ESP block before full action of intraoperative cryoanalgesia as a method of acute pain control, safety of the method.

The results were compared in terms of demographics, pain levels, side effects of the pain relief medications in the postoperative period and lenght of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic NUSS technique
* aged 10 years or above 10 up to 18
* informed consent signed for cryoanalgesia informed consent signed for regional analgesia

Exclusion Criteria:

* Age of 9 years or below
* Refuse to receive cryoanalgesia or regional analgesia as primary pain relief
* Any contraindication to cryoanalgesia
* Difficult follow-up for geographical reasons and/or impossibility by the patient to understand how to perform self-measurements
Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans

The purpose of this study is to compare the dose related effects of orally administered TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to provide written informed consent
* Males and non-pregnant, non-breastfeeding females;
* Subject is willing to undergo multiple radionuclide scans
* Subject BMI is between 18 and 35 kg/m2
* Subject has a negative urine drug screen
* Subject has screening laboratory values that are within normal range for the analyzing laboratory

Exclusion Criteria:

* Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
* Unable to withdraw medications 48 hours prior to the study:
* Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
* Analgesic drugs including opiates, NSAID, COX 2 inhibitors
* GABAergic agents
* Benzodiazepines

NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.

* Female subjects who are pregnant or breast feeding.
* Clinical evidence (including physical exam, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
* History of allergic reactions to ginseng, ginger, and Sichuan pepper.
* History of lactose intolerance.
* Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
* Subjects who have participated in another clinical study within the past 30 days.
Exercise Prehab in Older Adults With Hematologic Malignancies

This pilot trial studies a structured exercise program intervention in improving physical activity in older patients with hematologic malignancies undergoing cancer therapy. Patients with hematologic malignancies are at an increased risk of functional dependence and injury. Structured exercise programs, such as the Otago exercise programme (OEP), may improve balance, strength, and prevent fall-related injury in older patients with hematologic malignancies undergoing cancer therapy.

PRIMARY OBJECTIVES:

I. To assess the feasibility of implementing a structured exercise program by evaluating recruitment and retention, exercise program adherence, sustainability, adverse events, and implementation challenge.

SECONDARY OBJECTIVES:

I. To calculate preliminary effect sizes of the impact of an exercise program in patients with hematologic malignancy undergoing therapy, as measured by:

* Cancer and Aging Research Group (CARG) Geriatric Assessment Tool parameters.
* Change in Short Physical Performance Battery (SPPB).
* Number and severity of falls.
* Impact of motivation and self-efficacy on adherence.
* Hospital readmission rates (if applicable).
* Length of inpatient stays (if applicable).
* Patient Reported Outcome Measurement Information System (PROMIS) for Health related quality of life (HRQL).
* Correlative analysis of peripheral blood biomarkers of aging and inflammation (cyclin-dependent kinase inhibitor 2A \[p16\], inflammatory biomarkers, immunosenescence, micro \[mi\] ribonucleic acid \[RNA\]).

OUTLINE:

Patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. Patients also undergo an individualized exercise program at home for 6 months. The program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week.

After completion of study, patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancy receiving care (chemotherapy, immunotherapy, targeted agents, bone marrow transplant, or other) for their hematologic malignancy at the Ohio State University
* Impairments in physical function, as defined by a score \< 9 on the SPPB pre-screen
* Medical clearance from an oncologist or primary care physician stating the participant is able to participate in an unsupervised, moderate-intensity physical activity program
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Prisoners
* Any medical condition including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study procedures
Safety Study of Larazotide Acetate to Treat Celiac Disease.

To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.

CLIN1001-002 was a Phase 1b, randomized, double-blind, placebo controlled study to determine the safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of larazotide acetate in subjects with celiac disease subjects. Study subjects were randomized (2:1) to receive single oral doses of larazotide acetate 12 mg or matching placebo once daily for 3 days. Subjects received a single-blinded gluten challenge (5 mg amygluten) on Day 2. Intestinal permeability was measured each day following dosing. Intestinal permeability was measured by administration of an oral sucrose, lactulose and mannitol solution followed by a 6-hour urine collection. Serial blood samples were collected for pharmacokinetic determinations at baseline and 2 and 3 hours post dose; for zonulin determinations at baseline (prior to first dose) and 3 hours post dose; and for cytokine determination at baseline and 3 hours post dose (Days 2 and 3 only) and on Day 7. Sucrose, lactulose, mannitol, zonulin and larazotide acetate concentrations were determined by validated analytical methods.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have been diagnosed with celiac disease by biopsy for ≥ 6 months (attending physician confirmation will be accepted in lieu of a biopsy report).
* Subject must be on a gluten-free diet for at least the past 6 months.

Exclusion Criteria:

* Subject has Anti-Tissue Transglutaminase (tTG) \> 10 EU as measured by serology
* Subject intermittently consumes clinically significant quantities of non-steroidal anti-inflammatory agents ("NSAIDs") and proton-pump inhibitors, within the last 3 days prior to the treatment visit.
Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

The purpose of this study is to evaluate Cognitive-behavioral therapy (CBT) for deployment-related post-traumatic stress disorder (PTSD) that can be used by behavioral health consultants working with Service Members in the primary care clinic. CBT is a well-researched, very effective individual (one-to-one) treatment that is designed to help people to directly deal with traumatic events they have suffered in the past, including combat. Many Service Members prefer to see behavioral health providers in primary care rather than the mental health clinic. The researchers hope to learn if a brief treatment for PTSD in primary care can be just as useful as more traditional treatment given in the mental health clinic. This study will enroll approximately 45 participants overall; with approximately 30 participants at Wilford Hall Medical Center or Brooke Army Medical Center, and 15 participants to be enrolled at the South Texas Veterans Health Care System over a period of one year.


Eligibility Criteria:
Inclusion Criteria:

* The target population for the study is active duty, reserve, guard, separated, or retired OIF/OEF veterans (minimum age 18 and English speaking) in the primary care population who are symptomatic for deployment-related PTSD and interested in treatment.
* Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList - Military (PCL-M).

Exclusion Criteria:

* The exclusion criteria are those that would normally apply for standard of care behavioral health consultation in an integrated primary care clinic.
* These exclusion criteria are moderate to severe suicide risk, current alcohol dependence, psychotic disorder, significant dissociative disorder, and severe brain injury.
Safety and Efficacy Study of rhAngiostatin Administered in Combination With Paclitaxel and Carboplatin to Patients With Non-Small-Cell Lung Cancer

The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer.


Eligibility Criteria:
Inclusion:

* Histological or cytological confirmed Stage IIIB NSCLC with malignant pleural effusions, or Stage IV NSCLC or recurrent NSCLC
* No previous chemotherapy for NSCLC
* Have one lesion that is bidimensionally measurable by physical exam, MRI, or CT greater than 1 cm in diameter
* Specified lab parameters
* Life expectancy of at least 12 weeks
* ECOG performance status of 0 or 1
* Understand requirements of study
* Agree to use effective contraceptive methods

Exclusion:

* Have CNS metastases
* Have any active cancer in addition ot NSCLC
* Participated in clinical trial involving conventional or investigational drugs within previous 4 weeks
* Have any contraindication to paclitaxel or carboplatin
* Have had Grade 3 or greater peripheral neuropathies
* Be pregnant or lactating
* Have a history of myocardial infarction or angina pectoris/angina in the last 6 months
* Have had significant (30 mL or more) hemoptysis with the past 3 months
* Have an active infection
* Have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder
* Be receiving concurrent treatment with therapeutic doses of heparin or coumadin
* Have had major surgery within 4 weeks of stating therapy
* Have additional uncontrolled serious medical conditions or psychiatric illness
* Received rhAngiostatin in other clinical protocols
Heavy Metals, Obesity and Cardiovascular Risk - Ancillary to Look AHEAD

To evaluate the relationship of baseline toenail chromium concentrations to weight loss, as well as the interaction between heavy metals and the beneficial effects of weight loss.

BACKGROUND:

Heavy metals are a heterogeneous group of highly reactive substances, which may act as essential cofactors for physiologic processes and/or as toxic elements. Chromium, in particular, has been associated with obesity, diabetes, and weight loss. Other heavy metals have been associated with some of the consequences of obesity, including hypertension, hyperlipidemia, and cardiovascular disease. The Look AHEAD Study, a large randomized controlled trial of intensive lifestyle intervention for weight loss in obese patients with Type 2 diabetes mellitus, provides an excellent opportunity to address the impact of chromium on weight loss and diabetes control, as well as to assess the impact of other heavy metals on the physiologic consequences of weight loss.

The study is ancillary to the Look AHEAD clinical trial which is sponsored primarily by the National Institute of Diabetes and Digestive and Kidney Diseases and secondarily by the National Heart, Lung, and Blood Institute, the National Institute of Nursing Research, the Office of Research on Women's Health, the National Center on Minority Health and Health Disparities, and the Centers for Disease Control and Prevention. The Look AHEAD study is a multicenter, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss in overweight diabetics.

DESIGN NARRATIVE:

This is an ancillary prospective observational study within the Look AHEAD trial. The ancillary study will collect toenail clippings from all participants (n = 5,000) at baseline and at the 1-year visit, and analyze a random subset of the toenails for their heavy metal content using instrumental neutron activation analysis. Toenails provide a time-integrated measure of heavy metal exposure, while instrumental neutron activation analysis provides the concentrations of about 50 heavy metals in the toenail samples, including chromium. This information will allow an evaluation of the relationship of baseline toenail chromium concentrations to weight loss, as well as the interaction between heavy metals and the beneficial effects of weight loss. The proposed study may provide, valuable insight into the determinants of the efficacy of weight loss interventions. In fact, the Look AHEAD trial, because of its size, may be one of the few studies in which these relationships can be measured reliably. In addition, the ancillary study will permit the setup of a specimen bank of toenails to be used in future case-cohort or nested case-control studies of the association of heavy metals with Look AHEAD endpoints, especially myocardial infarction and cardiovascular death.

Eligibility Criteria:
An estimated 5,000 obese diabetic subjects from the Look AHEAD clinical trial. There will be 2,500 women (50%) and 30% minorities.
PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy


Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of invasive BCC
* Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI therapy
* At least 1 measurable lesion
* ≥18 years of age
* Hepatic function, renal function, bone marrow function in defined lab-value-ranges
* Anticipated life expectancy \>12 weeks
* Consent to provide archived tumor biopsy material (all patients)
* Group 2: consent to undergo research biopsies
* Group 2: must not be a candidate for radiation therapy or surgery
* Comply with study procedures and site visits
* Sign Subject Information Sheet and Informed Consent Form

Key Exclusion Criteria:

* Ongoing or recent significant autoimmune disease
* Prior treatment with specific pathway-blockers (PD-1/PD-L1)
* Prior treatment with immune-modulating agents within 28 days before cemiplimab
* Untreated brain metastasis that may be considered active
* Immunosuppressive corticosteroid doses (\>10mg prednisone) within 28 days prior to treatment with cemiplimab
* Active infections requiring therapy, including HIV, hepatitis
* Pneumonitis within the last 5 years
* Cancer treatment other than radiation therapy, including investigational or standard of care, within 30 days prior to treatment with cemiplimab
* Documented allergic reactions or similar to antibody treatments
* Concurrent malignancies other than BCC, other than those with negligible risk of metastases or death
* Any acute or chronic psychiatric problems
* Having received a solid organ transplantation
* Inability to undergo contrast radiological assessments
* Breastfeeding, pregnant, women of childbearing potential not using contraception

Note: Other protocol-defined inclusion/exclusion criteria apply
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation

This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.

For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be able to provide an informed consent to participate.
2. Participant must be willing and able to comply with all of the study procedures and return for a day 2 visit.
3. Participants must be 22 to 59 years of age.
4. Participant or witness must be able to read or write in English.

Exclusion Criteria:

1. Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
2. Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
3. Participants with known clotting disorders or currently taking a prescription blood thinner.
4. Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
5. Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation.
6. Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.
7. A wrist circumference below 14 cm or above 23 cm.
8. An upper arm circumference \< 22cm or \> 42cm.
9. Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.
10. Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.
Location and Timing of Inhaler Use, Exacerbations and Physical Activity in Chronic Obstructive Pulmonary Disease

This was an observational pilot study to examine the usefulness of an electronic sensor that monitors short-acting beta-agonist inhaled medication use. The goals of this study were to: 1) test the feasibility of using the inhaler sensor to measure worsening symptoms and exacerbations, 2) characterize physical activity in patients with COPD, and 3) examine whether environmental factors can be linked to mild exacerbations measured by the inhaler sensor.

Objectives: This study tested the usefulness of a GPS-enabled inhaler to study the associations between air pollution, chronic obstructive pulmonary disease (COPD) exacerbations, and physical activity. Specific aims are 1) test the feasibility of using the inhaler sensor to measure worsening symptoms and exacerbations, 2) characterize physical activity in patients with COPD, and 3) examine whether environmental factors can be linked to mild exacerbations measured by the inhaler sensor.

Research Design: A 12-week observational, longitudinal pilot study of patients with COPD.

Methodology: Participants recruited at VA Puget Sound performed spirometry and completed baseline questionnaires. An inhaler sensor was placed on their albuterol inhaler to record the time and location of inhaler actuation throughout the three month follow-up. Each month participants answered questions regarding their breathing symptoms and physical activity. Physical activity was measured by self-report using a weeklong Physical Activity Checklist. A pedometer was worn at three 7 day periods. Public use air pollution and meteorological data will be linked to the inhaler data. We will compute descriptive statistics for all measures, including sociodemographics, exacerbation rates, inhaler use, air pollution exposures and physical activity levels. In addition, a time series analysis will be used to test if the frequency of inhaler use is associated with higher levels of daily air pollution.

Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC\<0.70
* FEV1 \>30% and \<FEV1\<65% predicted
* Participants must be able to walk without assistance
* No plans to leave the study area during the 12-week study period
* Non-smoker and not live with someone who smokes
* No history of asthma
* Use a short-acting bronchodilator