cyrilzakka/clinical-trials huggingface dataset:
Validity of Aortic Pulse Wave Velocity in Predicting the 6- Minute Walking Test Before Major Non-cardiac Surgery

Methods: Prospective observational study in adult patients requiring preoperative evaluation

Objectives: To determine the correlation between the aortic pulse wave velocity (AoPWV) and the distance walked in the 6-minute walk test (6MWT) Sample Size: For a desired precision of estimate of ± 0.10 (95% confidence interval) around a postulated validity correlation coefficient of r = 0.70 (for an AoPWV in the distance prediction of 6MWT) a sample of 100 patients. By allowing a 25% wear rate, a final sample size of 125 participants is required Inclusion criteria: Patients older than 18 years undergoing any surgery and who require pre-anesthesia Statistical analysis If the variables have a normal distribution, the Pearson correlation coefficient (r2) is used, which is between -1 and 1. Where -1 indicates the highest possible negative linear relationship (increasing the value of a variable decreases the another), 0 that there is no association, +1 positive correlation. From 0.7 negative or positive, it is said that the association is strong.

Linear regression models of ordinary least squares will be applied to obtain the validity coefficient (r) and the standard error of the estimate (SEE): the typical error associated with the prediction the AoPWV with the distance traveled in the 6MWD test in each individual patient. The analysis of the receiver operating characteristic curve (ROC) will be used to derive cutoff points for an AoPWV value for the prediction of a 6MWD less than 427 meters


Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years undergoing elective surgery that receive a preoperative visit by anesthesiologists.

Exclusion Criteria:

* Patients undergoing emergency surgery

  * Patients under 18 years of age
  * Patients who refuse to participate
  * Patients unable to perform the 6MWT
  * Claudication of the lower extremities and inability to maintain a constant pace of walking on level ground
Improving Adult Protective Services Client Outcomes: A Stepped-Care Social and Mental Health Engagement Program

The purpose of this study is to ascertain the feasibility and effectiveness of an 8-week social engagement program aimed at reducing depression and increasing social engagement among seniors who are transitioning out of Adult Protective Services (APS) for either elder abuse or self-neglect.


Eligibility Criteria:
Inclusion Criteria:

Older Adults

* an APS validated EM/SN case
* able to provide informed consent
* able to speaks English or Spanish,
* community-dwelling,
* able to hear sufficiently using the telephone
* transitioning out of APS intervention (i.e. in the case closure phase of the APS service).

Student

* college or university student
* enrolled at one of the UTHealth graduate programs in Houston, University of Houston, Texas Southern University, Sam Houston State University, or Rice University
* commit to making 8-weekly consecutive calls
* complete the required 1-hour training and assessment.

Exclusion Criteria:

Older Adults

* Individuals needing a proxy to consent
* suspected or confirmed decision-making capacity impairments or uncontrolled psychiatric illnesses such as schizophrenia, paranoia, delusion, or delirium
* Older adults transitioning to a nursing home, assisted-living, or residential care facility

Student

-only engaging in the program to fulfill some educational requirement
Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility Criteria:
Inclusion Criteria:

* documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
* receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.

Exclusion Criteria:

* receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
* scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

Other protocol-specific exclusion/inclusion criteria may apply.
LIFU for Chronic Pain

This research project is examining the effects of noninvasive brain stimulation on chronic pain. We believe this study will help us to better understand possible treatments for chronic pain patients. Subjects will undergo functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, which is a way to take pictures of the brain and skull. Subjects will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Subjects will undergo pain testing using a small device that will increase the temperature of their skin and will rate this pain. Brain signals (EEG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored. Subjects will complete behavioral questionnaires. Each study session is expected to take 1.5-3 hours. Total participation takes 10 weeks.

This is a 2-arm, sham-controlled, cross-over design. This study is collected over 5-7 study visits.

Initial Imaging (1): MRI and CT scans, Questionnaires, and QST Testing.

Intervention (2): Sham or verum LIFU application every 10 minutes, totaling in 8 applications. Between LIFU or Sham application quantitative sensory testing (QST) will be performed. Physiological data collection such as EEG, EDA, BP, ECG, and Respiration will be collected throughout the study visit.

Follow-Up Imaging (2-4): Following intervention sessions participants will receive a resting-state MRI. This can occur throughout the 4-weeks following an intervention visit. Participants will be scanned at least once after each intervention session.

Follow-Up Virtual Questionnaires: Following intervention sessions participants will receive a link (or a phone call if preferred) to periodically rate their pain and report on various lifestyle impacts of their chronic pain. Participants will complete these questionnaires at least twice per week in the 2 weeks following an intervention visit. These questionnaires will take less than 30 minutes.

After completing the intervention and minimum 4-week washout period, the participant will return for a second intervention visit and 3 week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a chronic pain diagnosis. Pain must be moderate-to-severe and present for at least 3 months prior to research participation. Patients of all ethnicities, who understand and speak English.

Exclusion Criteria:

* Claustrophobia (scanning environment may be uncomfortable).
* Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
* Contraindications to CT: pregnancy
* Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer\&#39;s)
* History of neurologic disorder. (e.g. Parkinson\&#39;s, Epilepsy, or Essential Tremor)
* History of head injury resulting in loss of consciousness for \&gt;10 minutes.
* History of alcohol or drug dependence (through self-report).
A Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder.

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of combination cholesterol medications to see how the different treatments compare to one another.

For additional information please call: 1-800-718-1021

Eligibility Criteria:
Inclusion Criteria:

* Specific LDL-C levels based on CHD risk after a six-week washout period.

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
* Subjects requiring systemic steroids
* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study.
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer

The purpose of this study is to test 2 different methods of surgery to remove cancer in the esophagus. This research is being done to see whether removing more tissue and lymph nodes surrounding the tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers better control of the cancer than removing less tissue and lymph nodes (known as non-en bloc esophagectomy).

The aim of this study is to determine the 5-year disease-free survival, overall survival, and time to progression comparing (Arm A) transthoracic en bloc esophagectomy and (Arm B) transhiatal or transthoracic non-en bloc esophagectomy. Randomization to the two surgical arms will take place after the patient has given written informed consent and eligibility has been established. Patients will be informed of their randomized arm prior to the day of surgery. Preoperative chemotherapy may be administered at the discretion of the treating physician. Adjuvant chemotherapy and/or radiotherapy will be prescribed at the discretion of the treating physician. All patients will be followed for recurrence and survival for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cT2-T3/N0-N1-M1a-M1b(lymph node metastasis only) esophageal squamous cell and adenocarcinoma who have potentially resectable disease.
* Karnofsky performance status greater than or equal to 80%.
* Pulmonary and cardiac function must be acceptable for surgery according to institutional standards.
* Acceptable hepatic, renal and bone marrow function.
* Age 18 or older.
* Patients may receive preoperative chemotherapy and/or radiation therapy as part of their clinical care.

Exclusion Criteria:

* Patients with clearly unresectable or metastatic esophageal cancer or clinical stage I esophageal cancer.
* Significant psychiatric illness that would interfere with patient compliance.
* Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
* Patients with a significant history of unstable cardiovascular disease (e.g., inadequately controlled hypertension, or angina; myocardial infarction within the previous 6 months; ventricular cardiac arrhythmias requiring medication; congestive heart failure that in the opinion of the treating physician should preclude the patient from protocol treatment.
* Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
Treatment for Sexual Dysfunction in Women with Spinal Cord Injury

Women with spinal cord injury frequently experience sexual dysfunction such as disturbances during arousal and an increased time to orgasm. However, little evidence has been found on its therapeutic approach and low adherence. To verify the effectiveness of two interventions: the application of genital vibration and transcutaneous stimulation of the tibial nerve.

This is a randomized clinical trial. 54 women will be recruited who suffer from sexual dysfunction.

The allocation will be randomly assign to the three groups: an intervention group 1 transcutaneous electrostimulation of tibial nerve (n = 18), an intervention group 2 genital vibration (n = "18) and a control group (n = 18). The treatment time will be 12 weeks. Treatment adherence, as well as treatment effectiveness, will be evaluated through the Female Sexual Function Index, the "Sexual Quality of Life-Female" questionnaire, quantitative sensory tests and the improvement reported by the patient in arousal and orgasm. Evaluations will be carried out before treatment, at the end of the treatment, and at 3 and 6 months after the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women with incomplete spinal cord injury B, C or D (with preservation of the sacral arch and sensitive assessment of the lower dermatomes not absent, paying special attention to the sensitivity of the genital area) level below T6.
* between 18-60 years
* hormonal analysis. Participants do not present menopausal values of the hormone FSH (follicle stimulating hormone ) (31- 134 U / L)
* present some type of sexual disorder secondary to spinal cord injury with at least 12 months of evolution
* from Spain
* willing to attend the evaluation and treatment center
* seeking to improve in the sexual area.

Exclusion Criteria:

* women with active pregnancy
* present pre-existing pathologies in the genital area
* genital malformation, previous neurosurgery that affects the genital response capacity
* sexual disorders before the injury
* pressure ulcers, serious medical illness or any type of pathology in which the use of sick leave is contraindicated frequency
* psychiatric disorder, narcotic dependence, use of specific serotonin reuptake inhibitors, antipsychotics or other drugs that affect sexual response.
* does not sign the informed consent.
Phase II RCT of an Internet-adaptation of Managing Cancer and Living Meaningfully (iCALM)

iCALM is an online adaptation of a brief, individual, psychosocial intervention called Managing Cancer and Living Meaningfully (CALM) in patients with advanced and metastatic cancer. CALM has been shown to reduce or prevent depression in this population. The purpose of this study is to evaluate iCALM with regards to its acceptability, feasibility and preliminary efficacy in reducing or preventing psychological distress and improving psychological well-being in patients with advanced cancer.

Patients with advanced cancer are at risk for depression due to the disease and to side effects from its treatment. Depression in this population decreases quality of life and adherence to treatment and increases the risk of suicide. Psychotherapy can be effective to treat depression, but most patients affected by cancer and depression do not receive it, due to a lack of tailored therapies or trained clinicians in cancer treatment centres or in the community. To address this issue, we developed a novel 3-6 session psychotherapy intervention called Managing Cancer and Living Meaningfully (CALM) to prevent and treat depression in patients with advanced disease. In a large randomized controlled trial (RCT), we demonstrated that CALM reduces or prevents depression in these patients. However, since access to trained clinicians is limited, we will develop an online version of CALM, referred to as iCALM, and test its feasibility and preliminary efficacy. In the present study we will: i) adapt the CALM intervention to its online delivery; and ii) recruit 50 patients at the Princess Margaret Cancer Centre (PM), who will be randomized (25 patients per group) to receive either iCALM or usual care. Usual care patients will be offered iCALM at the end of the study on compassionate grounds. Questionnaires assessing intervention satisfaction, depression, death anxiety, and quality of life will be administered at recruitment and after 4, 8 and 12 weeks. Qualitative interviews will be conducted with patients and eCoaches to explore their experience of using iCALM.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* ability to read and write in English;
* able to access the internet.
* not cognitively impaired;
* able to commit to the required online sessions; and
* patients at Princess Margaret Cancer Centre with a confirmed or working diagnosis of advanced or metastatic cancer with an expected survival of 12-18 months \[stage III or IV lung cancer, any stage of pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer or other stage IV (metastatic) GI cancer; stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological (GYNE) cancer; and stage IV breast, genitourinary (GU), sarcoma, melanoma or endocrine cancers\].

Exclusion Criteria:

* Inability to pass the cognitive screening test (Short Orientation-Memory-Concentration Test (SOMC) score \<20, Katzman et al., 1983); and
* actively receiving a structured or semi-structured psychotherapy at Princess Margaret Cancer Centre
Assessment of the Effectiveness of Corticision Combined by Selfligating Bracket System on the Acceleration of Orthodontic Tooth Movement; A Prospective Clinical Study

the goal of this clinical trial is to assess the effectiveness of the corticision with self-ligating bracket system on the acceleration of orthodontic tooth movement.The main question it aims to answer is whether or not there would be an augmented effect by undergoing corticision with using self-ligating brackets regarding the acceleration of orthodontic tooth movement.


Eligibility Criteria:
Inclusion Criteria:

* Class I orthodontic patients with mild to moderate crowding of upper anterior segment (2-4 mm) All permanent teeth are erupted (3rd molar not included). Good oral and general health No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement No previous orthodontic treatment.

Exclusion Criteria:

* Orthodontic cases with severe crowding of upper anterior segment that require extraction treatment approach. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment. Patients with untreated decay or endodontic lesion.
Intraopertive Hypotension and Postoperative Cardiovascular Complications Among Chinese Elderly Patients Undergoing Oncardiac Surgery : a Retrospective Cohort Study

To explore the relationship of intraoperative hypotension and perioperative cardiovascular complications in elderly noncardiac surgical patients


Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years
* Undergoing general anesthesia
* Inpatients who had noncardiac surgery between January 1, 2012 and August 31, 2019

Exclusion Criteria:

* ASA grade V
* Low-risk surgery (hysteroscopic and body surface surgery)
* Length of surgery ≤30 min
* Short operation interval (less than 3 days between procedures)
* Without intraoperative blood pressure value at 30s intervals
* Missing data on patient characteristics.
Cocaine-Metyrapone Interaction Study - 1

The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.

To evaluate the safety of metyrapone (MRP) for using in an outpatient study in which participants would be given 2 750 mg doses of MRP per week. Secondary study goals are to evaluate the possible efficacy of MRP as a treatment for cocaine dependence and to compare 3 factors hypothesized to induce cocaine craving: cocaine cues, stress, and cocaine itself. This study will utilize a Double Blind, placebo-controlled crossover design with 3 factors: 1) medication 2) relapse trigger and 3) infusion for an 11 day in-patient treatment.

Eligibility Criteria:
Inclusion Criteria:

Male or Females between 18 and 45 yrs of age; cocaine dependence according to DSM-4; females of child-bearing potential must test non-pregnant and use adequate birth control; be able to provide consent, comply with protocol requirements and try to complete all study treatments.

Exclusion Criteria:

Additional criteria available during screening at the site.
Patient Satisfaction With Colonoscopy in a Danish Setting - What Are the Most Important Factors?

The study aim is to investigate factors associated with patient satisfaction during a colonoscopy.

The study aim to capture key quality indicators and patient satisfaction for 800 patients referred for a colonoscopy at Aalborg University Hospital. The patient population is mix of screening and non-screening colonoscopies seen at our out-patient clinic.

Each Colonoscopy is registered using a specially designed registration form and a more detailed form relating to the colonoscopy itself. The data collected includes: The Colonoscopist endoscopy experience and education, Medicine use, Colonoscopy duration, Unadjusted Caecum Intubations rate, Polyp detection rate, Polyps removed, Cancer detection rate and Nurse assisted Gloucester Comfort score.

Patient level data were recorded using a questionaire with 6 questions regarding satisfaction, pain, discomfort etc on a 10 cm analog scale.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred to colonoscopy at the out-patient clinic at Aalborg University department.

Exclusion Criteria:

* Rejection to fill out questionaire.
* Patents referred to AVA (advanced endoscopy unit) were excluded as the are not comparable to regular colonoscopies. Most patients are referred to AVA for specific endoscopy treatments such as large polyp removals etc.
Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

Lead survivability will be summarized.

The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

Eligibility Criteria:
Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive an Attain Ability Model 4396 LV lead
* Patient within 30 day post implant enrollment window

Exclusion Criteria

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results