cyrilzakka/clinical-trials huggingface dataset:
ICBT Program for Caregivers of Persons With SCI

Spinal cord injuries have a devastating effect on individuals incurring the life changing event; however, the injury can also affect those who are integrally involved in their care. Assisting individuals after an SCI frequently falls on unpaid, family caregivers. Studies have reported that caregivers experienced significantly greater negative outcomes than positives. The most common negative outcome factors were high levels of burden, poor adjustment to role, decreased QOL, emotional distress, and strain on relationships. Burden of care was also associated with lower levels of functioning of the care recipient, demonstrating the integral relationship between those who provide care and those who receive it. Considering their importance in maintaining their care recipient's wellbeing post-injury, caregivers require ongoing support as a central part of the wider healthcare system. Numerous caregivers are unprepared to handle the responsibilities of their role and lack specialized training to efficiently cope with the burden. Guided internet-delivered CBT (ICBT) offers an accessible and flexible approach for psychosocial service delivery in the community. Evidence for the effectiveness of ICBT has been reported in various populations. The results from our study provide evidence for the potential of guided ICBT to improve psychosocial outcomes among those with SCI. Enhancing the overall wellbeing of the caregiver has previously been shown to improve outcomes of those with SCI. However, evidence for the acceptability and effectiveness of an ICBT approach among caregivers is lacking; as a first step, we plan to conduct a feasibility study of ICBT for SCI caregivers.


Eligibility Criteria:
Inclusion Criteria:

1. adults ≥ 18 years
2. have provided care to a person with SCI in the community for a period of over six months post injury
3. report elevated symptoms of anxiety and/or depression
4. access to a computer and the internet
5. cognitive capacity to read and understand the content of the intervention.

Exclusion Criteria:

1. high risk of suicide
2. primary problems with psychosis, alcohol or drug problems, mania
3. currently receiving active psychological treatment for anxiety or depression
4. concerns about online therapy.
Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia

More than 90% of hand surgery is performed under local anesthesia and can be a source of anxiety, especially in an emergency context. The management of this intraoperative anxiety is essential for the comfort. The use of a virtual reality headset has shown its effectiveness in reducing anxiety in dental surgery or hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. It is known that audiovisual distraction also effectively reduces pain and anxiety in patients with fewer side effects.

The investigators have therefore chosen to use the RELAX® glasses. There are no publications examining the effectiveness of positive distraction as a non-pharmacological agent to improve the patient experience during emergency management in the operating room in the context of hand surgery under locoregional anesthesia. The investigatos would like to study its action on the anxiety, pain and global satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated for hand surgery under emergency locoregional anesthesia (Wounds, fractures and infections of the hand and wrist).
* Over 15 years and 3 months of age on the day of inclusion.
* Patient with written consent or additional parental consent in the case of minor patients.
* Socially insured patient.
* Patient willing to comply with all study procedures and duration.

Exclusion Criteria:

* Medical history contraindicating RELAX glasses: claustrophobia.
* Known and current alcohol and/or illicit drug abuse that may interfere with patient safety and/or compliance.
* Any condition that would make the patient unfit for the study: current presence of cognitive impairment (MMS \<15), severe psychiatric disorders (bipolar disorder, psychotic disorders according to the DSM-V classification).
* Pregnant or breastfeeding woman.
* Patient under court protection.
* Patient participating in another study.
* Patient's refusal to use the headset.
Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer

The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.


Eligibility Criteria:
Inclusion criteria

* Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3, M0, with tumor size of ≥ 2 cm
* All patients with early stage breast adenocarcinoma may enroll irrespective of receptor status
* No prior treatment for breast cancer excluding therapy for DCIS
* Karnofsky performance status of 80 - 100
* left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multiple gated acquisition (MUGA)
* Adequate hematologic, hepatic and renal function

Exclusion Criteria

* women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug
* Women who are pregnant or breastfeeding
* Inflammatory or metastatic breast cancer
* Unfit for breast and/or axillary surgery
* Evidence of baseline sensory or motor neuropathy
* Significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (HIV) infection
* History of prior anthracycline therapy Allergies to any study medication or Cremophor® EL
Effects of Sensomotoric Training on Neck/Scapular Pain in People With Visual Disability

The purpose of this study is to determine whether sensomotoric training can reduce neck/scapular pain in people with visual disability.

People with prolonged musculoskeletal disorders have impaired quality of life, physical function, work conditions and work ability and consume substantial public resources. An often overlooked fact in this context is the relationship between musculoskeletal disorders and the importance of a normally functioning visual system. People who have a visual impairment in adulthood often experience reduced health and life satisfaction. Many people lose their faith in order to continue with the activities previously carried out as to cope with their life, their work, and in some cases,personal care. Rehabilitative efforts to reduce the negative effects often involve the prescription of various visual aids which, in turn, often leads to unfavourable ergonomic and static postures with further increased risk of musculoskeletal problems. A prevention of such disorders is likely to allow them to continue their work, which is important from both an individual and a society perspective. The overall objective of the project is to evaluate the effects of an intervention program and develop a theoretical model for the relationship between near work, eye disorders and musculoskeletal disorders. The intervention is to be evaluated in a randomized trial on people with impaired vision and pain in the neck and scapular area. An intervention based on development and adaptation of an established physiotherapy practice in order to increase body awareness, body control and movement patterns will be evaluated. The effects of the intervention will be measured by a variety of outcome measures derived from WHO's ICF-model. An innovative solution for establishing proprioception and eye-hand coordination in everyday activities, the Clinical Kinematic Assessment Tool, will be used.

Eligibility Criteria:
Inclusion Criteria:

* visual disability
* age 18 to 67 years old
* pain in neck/scapular area
* living in Örebro county

Exclusion Criteria:

* deafness
* musculoskeletal disease (such as Multiple sclerosis, etc)
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation

To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 45-84 years at time of consent
2. Intended to undergo a standard-of-care screening colonoscopy
3. Considered by a physician or healthcare provider as being of 'average risk' for CRC
4. Willing to consent to blood draw prior to bowel preparatory procedures or undergoing colonoscopy ideally within 90 days of the date of the investigational blood draw.
5. Willing to consent to follow-up for one year as per protocol
6. Able and willing to sign informed consent

Exclusion Criteria:

1. Undergoing colonoscopy for investigation of CRC risk symptoms
2. Has undergone colonoscopy within preceding 9 years
3. Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
4. Has completed Cologuard or Epi proColon testing within the previous 3 years.
5. Has undergone a CT colonography in the prior 4 years.
6. History of colorectal cancer.
7. History of any malignancy within prior 5 years. (Patients with clear clinical evidence and documentation of being cancer free and patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study.)
8. Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
9. Positive family history of colorectal cancer, defined as having a first- degree relative (parent, sibling, or child) with CRC diagnosed at age \<60 years or with more than one first-degree relative diagnosed with CRC at any age.
10. Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\]).
11. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
12. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
13. Known pregnancy at informed consent, blood sample collection, and during study participation.
14. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy.
Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

Ibuprofen (also known as Advil or Motrin) is a medication that is known to reduce pain. It is also known that ibuprofen levels in the blood rise higher and faster if the medication is taken in liquid suspension. This study will attempt to determine if ibuprofen suspended in a liquid works to relieve sore throat pain faster than pills of ibuprofen. It will also determine whether patients with sore throat prefer to take pill or liquid form of the medication.

Pain is a common emergency and urgent care complaint. Ibuprofen is known to be an effective treatment for many forms of pain. Sore throat has been established to be an acceptable model of analgesic effect, and ibuprofen has been found to offer relief in studies of sore throat. Several studies have demonstrated that ibuprofen in suspension is absorbed into the system more quickly and results in earlier maximum blood concentrations. To date, no study has evaluated onset to analgesia as reported by the patient for suspension versus tablet formation of ibuprofen in an emergency department population presenting with complaints of sore throat. This is a double blinded randomized placebo controlled trial to compare suspension versus tablet ibuprofen in an emergency department population presenting with sore throat. The purpose of this study is to assess whether ibuprofen in suspension form results in relief of pain more quickly than the tablet form of an equivalent dose of ibuprofen. We will also determine if there is an interval difference from time of analgesia administration to perception of analgesia that is clinically significant.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 12 years and less than 65 years
* Weight \> 40 kg
* a provider order for ibuprofen to address pharyngitis pain.
* Initial Numeric Pain Score \> 6

Exclusion Criteria:

* Known allergy or hypersensitivity to aspirin or NSAIDs
* Inability to swallow pills
* Inability to carry out informed consent in English
* Inability to complete a visual analog pain scale
* A concomitant order for another class of analgesic
* Use of analgesic within 8 hours
* Known 3rd trimester pregnancy
* Significant medical conditions where participation would pose an unnecessary barrier to ongoing care.
* Those taking opioid medications for more than 3 days
* Weight \< 40 kg
Long-Term Safety Study of Tafenoquine

This randomized, double-blind, placebo controlled study will involve 600 healthy (Glucose-6-Phosphate Dehydrogenase \[G6PD\] normal) volunteers. Participants who meet the eligibility criteria will be randomized (ratio 1:1) to receive a loading dose of either tafenoquine 200 mg (2 x 100 mg tablets) or placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks, with safety follow-up visits at Weeks 4, 12, 24, and 52. All participants will return to the clinic at Week 64 for an end of study visit. If the participant has an ongoing AE at the Week 64 visit will continue to be assessed for up to 3 more times at approximately 12-week intervals or until resolution or stabilization of the AE whichever is earlier.


Eligibility Criteria:
Main Inclusion Criteria:

1. Completion of the written informed consent process (signed).
2. Male or female age 18 to 55 years inclusive, in good health as assessed by the Investigator.
3. Normal G6PD enzyme activity levels as defined by the parameters of the specific G6PD test employed at the local laboratory.
4. Negative HBsAg and HCV, HIV-1, HIV-2 antibody screen at the screening visit.
5. Negative serum pregnancy test.
6. Use acceptable method of birth control.
7. Hematology, biochemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant as judged by the Investigator in accordance with approved clinically acceptable laboratory ranges, documented prior to study start.
8. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Main Exclusion Criteria:

1. History of allergy or intolerance to tafenoquine, primaquine or any excipients.
2. History of thalassemia or current or past history of methemoglobinemia or methemoglobin \>2% at screening.
3. History of eye disease or surgery
4. Having previously received hydroxychloroquine for skin conditions or rheumatological diseases, chloroquine for malaria, tamoxifen, amiodarone or other drugs that may affect the optic nerve/retina/cornea within 30 days or 5 half-lives (whichever is longer) of study start. There are no travel restrictions, but the choice of concurrent anti-malarial must be atovaquone-proguanil if the participant chooses to take a registered antimalarial drug while travelling.
5. Any current diagnosis of Axis I psychiatric disorders
Treatment and Outcomes of Stage III Colon Cancer in Patients 80 Years of Age and Older

The objective of this study was to assess survival trends in elderly patients with stage III colon cancer

This retrospective population-based study included patients aged 80 years and older with stage III colon adenocarcinoma who underwent surgery between 2007 and 2014.

Eligibility Criteria:
Inclusion Criteria:

• Stage 3 colon adenocarcinoma

Exclusion Criteria:

* Rectal tumors
* Patients receiving neo-adjuvant chemotherapy or radiotherapy
* Tumours of the appendix
* Tumours with histology other than adenocarcinoma
Effect of Physician Race and Gender on Simulated Patients' Ratings

The purpose of the study was to determine whether the race and gender of a simulated doctor affected analog patients' reported confidence and satisfaction in the simulated doctor's diagnosis and treatment plan. The study used two randomized patient analog experiments.

This study is complete and pre-analysis plans (PAPs) for each experiment were published prior to data collection. The PAPs are available at: http://aspredicted.org/blind.php?x=43xj25 (Study 1) and https://aspredicted.org/blind.php?x=369st7 (Study 2).

Prior literature is unclear on whether patients display bias in their evaluations of physicians based on their race or gender. The investigators estimated the effects of physician race and gender using an online clinical vignette. Participants played the role of analog patients reporting to the Emergency Department (ED) with symptoms consistent with gastroenteritis. Participants were provided with a diagnosis of gastroenteritis by a simulated ED physician. The race (black or white) and gender (male or female) of the simulated physician was randomly assigned in a 2x2 factorial experiment. Simulated physicians provided a diagnosis of gastroenteritis and contradicted by an Online Symptom Checker. Following the physician's diagnosis and contradiction by the Online Symptom Checker, participants rated the simulated physician on survey measures of satisfaction and confidence in both the treatment plan and diagnosis. The main (null) hypothesis tested was that there were no differences across the four treatment arms (Black Female, Black Male, White Female, White Male). Participants for the first experiment (Study 1) were recruited from Amazon Mechanical Turk (MTurk) and participants for the second experiment (Study 2) were recruited from Lucid.

Primary Aim: To determine whether the race and gender of a simulated physician had a causal effect on participants' confidence and satisfaction in the physician's diagnosis and treatment plan in an ED setting.

Exploratory Aims: To determine whether the race and gender of a simulated physician had a casual effect on participants' perceptions of the warmth and competence of the physician, their willingness to sue or complain about the physician for an incorrect diagnosis, and their perceived fairness of the charge for the visit.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years old

Exclusion Criteria:

* Participants who reported current pregnancy
* Participants who reported a current or prior diagnosis of cancer
* Participants who reported a history of abdominal surgery
Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation

The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the number and percentage of T-regs in the peripheral blood post transplant at each dose level, the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and determining the time to engraftment: absolute neutrophil count (\>0.5 x 10\^9/L for 3 consecutive days), and platelet (\>20X 10\^9/L for 3 consecutive days).

The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. This may indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.


Eligibility Criteria:
Inclusion Criteria:

All patients age \> =18 who have been diagnosed with Multiple Myeloma and are scheduled for autologous peripheral blood hematopoietic stem cell transplant (AHSCT) will be screened for eligibility.

Patients must fulfill all of the following inclusion criteria to be eligible for this study:

1. Diagnosis of Multiple Myeloma
2. Age \>=18 and no more than 70 years.
3. Able to understand and sign a consent form.
4. Can collect peripheral blood stem cells with a CD34+ cell dose of at least 5.0 x 106/kg. The CD34 molecule is a Cluster of Differentiation molecule present on hematopoietic stem cells.
5. Conditioning regimen to be high dose Melphalan at a dose of 200mg/m2.
6. Karnofsky Performance Score (KPS) \>60 or ECOG (Eastern Cooperative Oncology Group) performance status \<=2
7. Kidney function:Creatinine \<2.0 mg/dl or creatinine clearance \>50 ml/min
8. Heart function: Ejection fraction \>45%
9. Liver function tests :Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
10. Lung function tests: Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) \>45% predicted

Exclusion Criteria:

1. Age \<18 years or \> 70 years
2. Previous exposure to denileukin diftitox.
3. Patients with documented uncontrolled central nervous system (CNS) disease.
4. Previous AHSCT.
5. Significant organ dysfunction deemed to be inappropriate for autologous transplantation.
Fast-track Surgery in the Treatment of Hirschsprung's Disease

To evaluate the safety and efficacy of Hirschsprung's disease

The patients are divided into two groups：fast-track surgery combined with laparoscope group and laparoscope with traditional managements group.Postoperative recovery,hospital stay,hospital cost and complcations were compared.

Eligibility Criteria:
Inclusion Criteria:

1. surgical treatment for Hirschsprung's disease
2. The first procedure for Hirschsprung's disease
3. Age\<14 years

Exclusion Criteria:

1. conservative treatment for Hirschsprung's disease
2. The reoperation for Hirschsprung's disease
3. Age\>14 years