cyrilzakka/clinical-trials huggingface dataset:
Direct Referral for Apnea Monitoring

The primary objective of this project is to compare a health care delivery model, Direct Referral for Apnea Monitoring (DREAM), with initial in-person (Traditional) clinic appointments for Veterans at risk for obstructive sleep apnea (OSA). A secondary objective is to determine the negative predictive value (NPV) of home sleep apnea testing (HSAT).

Patients referred to one of 3 participating VA sleep medicine clinics (San Francisco VA, VA Portland or VA Pittsburgh) for OSA will be assigned either to the Traditional clinical pathway (which might include an initial encounter with a sleep care provider through in-person visits, telephone clinics, or video conferencing) or the DREAM pathway which will omit the initial encounter with a care provider. After a clinician conducts a chart review of medical records, patients in the DREAM pathway will be referred for sleep testing. All patients will be tracked from the time of referral until 90-days past the initiation of treatment. To determine the NPV of HSAT, results of sleep tests will be compared for patients who undergo both HSAT and polysomnographic (PSG) procedures. Concurrent PSG and HSAT studies will be done at Portland, Pittsburgh, and San Francisco.

Eligibility Criteria:
Inclusion Criteria:

Age 18 years Agrees to be seen by a VA sleep program Reason for referral to sleep clinic: New OSA Evaluation

Exclusion Criteria:

Age \< 18 years Declines to be seen by a VA sleep program Reason for referral to sleep clinic: anything other than a new OSA evaluation
Oral Lesions in Patients With Eating Disorders

Eating disorders (ED) are common among young. Anorexia (AN) and bulimia (BN) are the most prevalent ED. The American Psychiatric Association's guidelines state a 0.3% AN prevalence among young girls and a 0.1 to 4.2% BN prevalence. Men are not excluded: even if ED are more frequent in females (14-18 years), 1 man off to 10 can be diagnosed with ED. Unfortunately, the onset age is decreasing. In the last few years, always more preteens patients are diagnosed with ED: they generally refer a garbled self perception of body image. ED can have oral manifestations, such as: mucosal lesions, dental erosion, glandular hypertrophy, xerostomia and salivary disorders, dental caries These are the most common manifestations observed in patients with eating disorders, after a routine dental visit. There is not strong evidence that dental caries may be directly related to disordered eating habits; as a matter of fact results are controversial. Despite that, all the studies examined agree on the association between signs listed above and food disorders. Univocal percentages have not been reported in the scientific literature. For instance, a systematic review, dated 2016, showed that dental erosion is diagnosed in 45% of ED people, while other studies documented 70% patients affected by erosion. Another example reported is teeth hypersensitivity. According to some studies, 56% of ED patients reported such complaints, instead of other researches documenting 22% hypersensitivity impairment. As for dental caries, results are dissimilar. Authors showed 78% ED subjects diagnosed with dental caries. Other studies reported almost 50% patients with tooth decay, without statistically significant difference in the values between ED people and controls. All these differences are probably due to the different stages of eating disorders and diagnosis, and oral signs found. Different ages are also considered. The primary aim of the study is to evaluate the prevalence of oral cavity lesions among people affected by eating disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ED
2. Age between 10 and 18 years

Exclusion Criteria:

1. Parents or caregivers not understanding the Italian language
2. Patients affected by other systemic diseases
Strategies for Coping With Negative Thoughts

The primary objective of this study is to assess the impact of two strategies for coping with negative automatic thoughts (positive thinking and cognitive restructuring) on one's belief in negative thoughts and one's affect. Another main objective is to assess whether participating in a positive mood induction (versus no mood induction) prior to using one of the two coping strategies impacts belief in negative thoughts and affect. We will also explore the interaction between strategy condition and mood induction condition. As secondary outcomes, we will evaluate whether there are changes in positive thinking skills and cognitive restructuring skills and depressive symptoms after one week of using the strategy.

Participants will be randomized to learn about positive thinking or cognitive restructuring, which will involve watching brief videos, being presented with examples of how one might apply the strategy when experiencing negative thoughts, and practicing with a personal example using a worksheet. Participants will also be randomized to positive mood induction, which is comprised of an autobiographical recall exercise in which participants are asked to recall a pleasant memory before filling out the worksheet. Participants will be asked to use the strategy and complete a worksheet online once per day for six days. Participants will respond to questionnaires at baseline and after 6 days of strategy use.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older.

Exclusion Criteria:

* A level of visual impairment that would prevent them from being able to answer questions on an electronic screen.
Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function

This study will evaluate the effect of various degrees of hepatic function on the pharmacokinetics and safety of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

For all subjects:

* Has a body mass index (BMI) of 18.0-35.0 kg/m2 and a total body weight \>50 kg
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply

For subjects with hepatic impairment:

* Has mild, moderate, or severe hepatic impairment
* Has hepatic dysfunction due to hepatocellular disease
* Additional criteria may apply

Exclusion Criteria:

For all subjects:

* Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than hepatic impairment
* Has a history of gastrointestinal surgery, excluding appendectomy or cholecystectomy
* Is pregnant, planning to become pregnant, or lactating
* Has a history of clinically significant allergy or a hypersensitivity to opioids
* Additional criteria may apply

For subjects with hepatic impairment:

* Has evidence of hepatocellular carcinoma, acute liver disease, biliary obstruction, severe ascites, severe portal hypertension, surgical systemic shunts, or other clinically relevant liver-related disorder or condition
* Has received a liver transplant
* Has had esophageal variceal bleeding in the past 2 months
* Additional criteria may apply
Wellness Tool in Anesthesia Providers

This study will examine the effects of Isha Kriya meditation on stress and burnout among healthcare providers.

In this study, investigators will evaluate the effect of Isha Kriya meditation on stress and burnout among perioperative healthcare providers. To do this, investigators will randomize healthy participants to one of two groups: one who will meditate twice daily for six weeks (group 1), and the other who will not meditate for first six weeks and then meditate for another six weeks (group 2). Investigators will then evaluate stress and burnout using validated electronic instruments at baseline and at six weeks for group 1 and at baseline, six weeks, and 12 weeks for group 2.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Perioperative healthcare provider

Exclusion Criteria:

* Low English proficiency
* Currently enrolled in another interventional study that could impact the primary outcome, as determined by the Principal Investigator
* Not currently residing in the United States
National Recommendations and the Actual Rehabilitation Provided for Low Back Pain Patients

Purpose and background:

The purpose of the study is to investigate physiotherapeutic courses of rehabilitation in the primary sector for low back pain patients. This is done by identifying both how physiotherapeutic rehabilitation is organized in the primary sector and further what different types of physiotherapeutic interventions are offered for this patient group. Furthermore the study aims to evaluate to what extent existing physiotherapeutic rehabilitation practice adheres with the national and international guidelines and recommendations for low back pain rehabilitation.

Methods:

A quantitative survey is carried out, which includes development and validation of a questionnaire for the purpose, and this is subsequently distributed electronically to private and public providers of physiotherapy rehabilitation in all 19 municipalities in Central Denmark Region. Approximately 500 physiotherapists will be asked to participate in the survey in the period February to March 2018.


Eligibility Criteria:
Inclusion Criteria:

* physical therapists working with low back pain rehabilitation in the primary sector in Central Denmark Region

Exclusion Criteria:

* physical therapists that have less than 1 consultation per week with low back pain patients.
Incentive Spirometry Prehabilitation Study

Postoperative pulmonary complications (PPCs) are the most common complication following thoracic surgery. PPCs are associated with prolonged hospital stay, increased morbidity, mortality, ICU admission, and healthcare costs (Azhar, 2015). Current preoperative optimization in this patient group includes smoking cessation and management of Chronic Obstructive Pulmonary Disease with inhaled bronchodilators and inhaled steroids as indicated. There have been studies using preoperative incentive spirometry in patients undergoing laparotomy with conflicting results, but scant data on its use in patients undergoing one-lung ventilation (Tyson, et al., 2015; Cattano, et al., 2010). A study from 2013 investigated the effectiveness of incentive spirometry in patients following thoracotomy and found conflicting results, without significant improvement in lung function or reduction in PPCs, but a larger difference in frequency of PPC was noted, indicating possible benefit to intervention and a need for further study (Agostini, et al., 2013). Volume-based incentive spirometry pre- and postoperatively has also been found to improve pulmonary function and diaphragm excursion in patients undergoing laparoscopic surgery (Alaparthi, et al., 2016).

Patients customarily receive an incentive spirometer for use postoperatively in the PACU. There is scant data in the thoracic surgery population concerning prehabilitation by dispensing the incentive spirometer at the PACT evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for thoracic surgery procedures involving one-lung ventilation
* open thoracotomy
* Video-assisted thoracoscopic surgery (VATS)
* Robotic-assisted thoracoscopic surgery (RATS)
* Procedures to include: Lung resection for any purpose, esophagectomy, thymectomy
* Patients undergoing esophagectomy performed by a general surgeon
* Patients willing and able to independently perform incentive spirometry

Exclusion Criteria:

* Trauma patients
* Lung Volume reduction surgery (LVRS)
* In-Patients
* Patients not undergoing one-lung ventilation
* Patients undergoing thoracoabdominal aortic aneurysm repair
* Transhiatal esophagectomy (does not involve one-lung ventilation)
* Lung transplantation
Working Memory Training and Neurofeedback for Children With ADHD, a Pilot Study

This pilot study compares the effect of working memory training and neurofeedback in non-medicated children age 7 to 13 years with ADHD. Half of the participants will receive working memory training, while the other half will receive neurofeedback.


Eligibility Criteria:
Inclusion Criteria:

* ADHD/ADD

Exclusion Criteria:

* Positive effect of metylphenidate
Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia

STOP-FALLS-D is an educational intervention to inform and activate patients, their care partner(s), and their primary care providers to work together to reduce use of central nervous system (CNS) active medications and prevent adverse outcomes (falls and injuries) associated with their use.

The study design is a pragmatic, one-arm pilot trial to test the feasibility and acceptability of implementing a deprescribing intervention with older people with dementia and their care partners in primary care. The intervention consists of patient-facing educational brochures on CNS-active medications and decision support for the primary care provider. Ethnic/minority groups will be over-sampled to ensure a diverse study sample.

Eligibility Criteria:
Older Adult Sample

Inclusion Criteria:

* Diagnosed dementia (dementia diagnosis code or prescription for dementia medication)
* Receiving primary care at a Kaiser Permanente Washington integrated group practice outpatient clinic
* Prescribed at least one CNS-active medication on a chronic (3 months or more) basis

Exclusion Criteria:

* Skilled nursing facility resident
* Current cancer diagnosis
* On hospice or palliative care

Care Partner Sample

Inclusion Criteria:

* Aged 18 years or older
* Self-identify as a care partner for the older adult with dementia
Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery

This study is to determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee Society Score and the WOMAC Score will be obtained from patients. Gait data will also be obtained from total knee replacement (TKR) patients at pre-operative and post-operative times. Gait data will be measured on unaffected normal controls as a second baseline.

The hypothesis is that the subjects clinical outcome measures do not accurately reflect gait dependent outcomes amd functional performance of the total knee replacement.

Patients scheduled to undergo unilateral total knee replacement (TKR) surgery will be the subjects of the study. A control group of Healthy volunteers, will serve as a control group. The control group will be matched as close as possible by age and gender to the TKR group. Both pre and post-operative (3 weeks, 6, 9 and 12 months follow-up) measurements will be performed on the TKR group.

A Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to record body motion, the sensors for the IDEEA device will be placed on the patient and secured with adhesive tape(if not allergic) once the IDEEA device is properly placed on the patient, measuring and calibrating can start.

The patient will be required to perform tasks, walking at a normal pace for approximately 100 feet on a level surface, walk up and down moderate incline ramp, climb stairs 7 to 8 steps, sit and rise from two chairs. Parameters will be measured on each subject, knee flexion angle( walking, stair climbing and sitting), velocity ( walking and stair climbing), Stride length (walking), Energy (walking, stair climbing, and sitting), other parameters will be added as needed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* needs unilateral total knee replacement

Exclusion Criteria:

* Active infection
* Autoimmune disease/ parkinson's disease
* HIV
* psychosocial disorders that would preclude accurate evaluation or substance abuse
* allergic to
* pregnant
* active malignancy
New Preclinical and Clinical Approaches to Mesothelioma

This study protocol involves the coordination between UO1 (IRCCS San Raffaele Hospital) and UO2 (Istituto Nazionale Tumori di Napoli - IRCCS G. Pascale) to explore the role of HMGB1 and CXCR4 in cancer treatment and metastasis. UO1 focuses on the role of HMGB1 in inflammation, mesothelioma progression, and tissue repair, as well as developing, in future, possible HMGB1 inhibitors for cancer therapy. UO2 specializes in CXCR4's role in cancer, developing CXCR4 antagonists, and tracking CXCR4-dependent metastasis. The hypothesis is that targeting HMGB1 and CXCR4 pathways will inhibit tumor progression and metastasis, enhancing anti-tumor immunity and improving therapeutic outcomes in cancer.

This is a multicentric cross-sectional observational study with an additional blood volume collected during blood sampling performed for normal clinical practice. The enrollment will take

Eligibility Criteria:
Inclusion Criteria:

* Patients with Mesothelioma:

Clinical suspicion or histologically confirmed diagnosis of pleural mesothelioma.

* Candidates for surgical intervention.
* Age 18 years or older. It is possible to include both male and female patients, male and female patients of reproductive age, as well as breastfeeding women.
* Capacity to comprehend the study nature and provide autonomously informed consent.

Control Group patients:

* Absence of pleural mesothelioma but presence of other histologically confirmed diseases (neoplastic, inflammatory, or infectious).
* Candidates for surgical intervention.
* Age 18 years or older. It is possible to include both male and female patients, male and female patients of reproductive age, as well breastfeeding women.
* Ability to understand the study nature and provide autonomously informed consent.

If the patient's diagnosis, whether provisional or definitive, does not confirm the clinical suspicion, they will not undergo further evaluation in the study.

Exclusion Criteria:

* Lack of biopsy material.
* pregnancy.
* Unwillingness to sign the Informed Consent.
Use of the Atkins Diet for Adults With Intractable Epilepsy

This is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.

Patients are seen in the Johns Hopkins General Clinical Research Center (GCRC) and started on a modified Atkins diet (15g/day of carbohydrates). Medications remain unchanged and labs are drawn. Followup is at 1 month, 3 months, and 6 months into the study. After 1 month, carbohydrates and medications can be altered. Ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar.

This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and over
* Weekly seizures or 4 times per month
* Use of at least 2 anticonvulsant drugs

Exclusion Criteria:

* Prior use of the Atkins diet for \> 1 week
* Prior use of the ketogenic diet within the past year
* Kidney, heart disease, renal disease
* Hypercholesterolemia
* Pseudoseizures
* Pregnancy
* Body mass index (BMI) below 18.5
* Status epilepticus within the past 6 months
* 2 week seizure-free period within the past 6 months
The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints

The purpose of this study is to clarify whether the matching acupoints are more effective than a single point by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

1. Be diagnosed as cancer and need to accept chemotherapy
2. The score of Karnofsky ≥70
3. Patients of either gender and age 18 years to 80 years
4. Patients receiving chemotherapy both outpatients and inpatients
5. Patients receiving chemotherapy regime with high risk of causing vomiting: cisplatin ≥60 mg/m2, or joint chemotherapy regime of Anthracyclines (Adriamycin≥ 40 mg/ m2 or epirubicin≥60 mg/m2), Dacarbazine or Carboplatin（area under the curve greater than 5mg/ml/min）
6. Life expectancy \> 6 months

Exclusion Criteria:

1. To receive radiotherapy and chemotherapy
2. Gastrointestinal tumors
3. Patients with serious liver disease or abnormal hepatorenal function (Aspartate Aminotransferase, Alanine Aminotransferase , and Total Bilirubin are 3 times more than normal, blood urea nitrogen and Cr are 2 times more than normal)
4. Presence of cardiac pacemaker
5. Inflammatory skin reaction
6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic disturbances)
7. Patients unable to provide self-care or communication
8. Nausea and/or vomiting resulting from mechanical risk factors (i.e.,intestinal obstruction)
9. Patients with brain metastases or symptoms of intracranial hypertension
10. Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)
11. Women in pregnant and lactating period
12. Refusal to sign informed consent, rejection of randomization into intervention groups.
Bronchoscopic EmphysemA Treatment in THE NetherLands

Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.

Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.

Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Study design: This study is a nationwide, multicenter, observational post-marketing study with long-term follow up (5 years).

Study population: The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

Main study parameters/endpoints:

The main study parameter is the assessment of Target Lung Volume Reduction (TLVR) and correct placement of the valves at CT-scan at 30 days post treatment. This is the most accurate and directly treatment related endpoint which will also be used for quality control.

Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves.

Exclusion Criteria:

* There are no exclusion criteria for this study.