cyrilzakka/clinical-trials huggingface dataset:
Electronic Media and Its Application in Psychotherapy

This randomized control trial aims to establish whether viewing and discussing patients' electronic communication (texts, emails, Facebook direct messaging, etc) impacts clinical care and decision making across the lifespan.

This study explores the usefulness and effectiveness of including electronic communication as part of standard clinical care. Participants will provide information and content from their electronic media to research assistants during in person interviews if they are in the intervention group. Research assistants will then give clinicians the information collected, so the clinicians can incorporate the data into the session as they see fit. Therapists will retain full clinical discretion of how they continue to conduct their therapy sessions. The investigators will compare the impact of receiving this electronic enhancement intervention versus only receiving treatment as usual care on mental health related functioning and therapeutic alliance.

Eligibility Criteria:
Inclusion Criteria:

1. Are currently receiving psychotherapy at McLean and have had at least 4 visits with their current therapy provider in outpatient clinics or 2 sessions with their therapy provider in partial hospitalization or residential settings
2. Age 18-85, and fluent in English
3. Have a primary diagnosis of anxiety or depression (as determined by self-report and review of medical records, which should list a primary depression or anxiety spectrum diagnosis). Symptomatology can be active or in remission.
4. Are actively using at least 1 platform for text messaging (i.e. they should have an account on each platform and have produced content within the month prior to beginning the study). This will be based on self report.
5. Use a mobile device for text messaging
6. Able to provide informed consent.

Exclusion Criteria:

1. Probable or diagnosed dementia or cognitive impairment, or neurodevelopmental disorder (such as an autism spectrum disorder) based on self report and review of medical records.

   - Individuals with Attention-Deficit/Hyperactivity Disorder (ADHD) or Attention-Deficit Disorder (ADD) may be eligible provided symptoms have been stable for at least 6 months.
2. Active psychotic symptoms

   - History of psychosis is allowable only if the patient has not had symptoms for at least a year
3. Are actively receiving ECT treatment
4. Current alcohol or drug abuse problem (based on self report and review of medical records)

   - History of substance use is fine, provided there has been no relapse or withdrawal symptoms in the month leading up to enrollment
5. Are involuntarily admitted to McLean Hospital
Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan

This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was designed,included in which patients with ulcer and/or pain at rest were treated with bosentan p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor amputation rate, hemodynamic changes, changes in endothelial function and angiographic changes.

12 patients were included were current smokers. With bosentan treatment, no new ischemic lesions were observed in all but one patient. Overall, clinical improvement was observed in 12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic resonance image an increase of distal flow was observed in 10 out of the 12 patients. All patients experienced a statistically significant improvement in their BAFMD values (means:1.8 at baseline;6.6 at the end of the treatment;12.7 three months after the end of the treatment;p\<0.01). In conclusion: Bosentan treatment may result in an improvement of clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves further investigation in the management TAO patients.


Eligibility Criteria:
Inclusion Criteria:

* Critical ischemia in any extremity, causing pain at rest or non-healing ischemic ulcers, present for at least four weeks with no evidence of improvement in response to conventional treatment.

Exclusion Criteria:

* Being candidates for surgical or endovascular revascularisation of the extremity studied.
Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal Position

The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.


Eligibility Criteria:
Inclusion Criteria:

* Is 18 - 85 years of age
* Is presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and is eligible for a revascularization with a bifurcated graft
* Is affiliated with a social welfare organization system
* Is willing to participate in the clinical evaluation after signature of the informed consent
* Is able to attend all follow up visits and diagnostics and laboratory exams required by the present protocol

Exclusion Criteria:

* Is treated as an emergency
* Is included in another investigation
* Is pregnant or lactating, or a woman of childbearing potential unwillint to use an effective form of contraception for the duration of the trial
* Has a known allergy to the material device used
* Has previous aorto-iliac bypass or replacement
Diagnostic Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples

Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in cerebrospinal fluid samples of immunocompromised patients for identification of central nervous system aspergillosis.


Eligibility Criteria:
Inclusion Criteria:

* Host factors
* Informed consent

Exclusion Criteria:

* none
Pre-habilitation Interventions to Empower Patients With Chronic Pain

The development of alternative methods to address simple clinical needs and easy interventions of self-application are desired in the pre-habilitation period (waiting list). To our knowledge that are very few studies regarding interventions for patients in waiting list for specialized treatment of chronic non-cancer pain (CNCP) and they do not include cognitive-behavioural programs. This project is based on the hypothesis that educational and cognitive-behavioural interventions help to reduce deleterious effects of pain on some areas of patient's life. Therefore, the goal is to test two different interventions to help patients to self-manage their pain and avoid worsening in the pre-clinical period.

It is a randomized controlled trial for application and assessment of two interventions: an educational Video-based Pain Program (VP) and Empowered Relief Program (ER). The primary purpose of our study is to investigate the effect of ER and VP on the Pain Catastrophizing Score in people with CNCP who are waiting for Multidisciplinary pain treatment. The secondary aim is to analyse the effects on other patient reported outcomes such as pain intensity, pain interference in daily activities, pain catastrophizing, pain acceptance, quality of life, mood, perceived change on over-all pain status, as well as consumption of pain medicine and usage of healthcare services. The effects of the two interventions will be compared with each other and a control group.

Eligibility Criteria:
Inclusion Criteria:

* First appointment date at the Multidisciplinary Pain Centre scheduled at least three months after the invitation to participate in this study
* At least 18 years old
* Fluent in the Danish language
* Access to internet
* Willing and available to participate in the study

Exclusion Criteria:

* History of cognitive dysfunction that interfere with understanding of the educational program and answering the questionnaires
* Epilepsy
* Current history of severe depression
* Current use of private pain services
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT

Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a transplant of autologous CD34+ cells transduced with an antiviral vector (M87o). If autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a compatible donor is available. To minimize risk of transplant failure, a second unmodified CD34+ cell transplant will be given one week after the first transplant.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of any ethnic group aged between 18 and 65 years
* HIV-positive patients with malignant diseases of the blood (NHL, Hodgkin disease, plasmocytoma, acute and chronic leukaemia) who failed to achieve complete remission (CR) after standard-dose first-line chemotherapy or had a chemosensitive relapse after an initial CR
* Patients must receive HAART

Exclusion Criteria:

* Any of the following conditions:

  * congestive heart failure (NYHA \> II)
  * documented EBV, HBV or HCV infection (only for allogeneic PBSCT)
  * creatinine clearance \< 60 ml/min
  * left ventricular ejection fraction \< 40%
  * bilirubin \> 2 mg/dl
* Severe opportunistic infection
* More than 10% of bone marrow involved with lymphoma
* Between 2 and 5 10\^6 autologous CD34+ cells/kg BW obtained after leukapheresis and CD34 enrichment
* Women of child.bearing potential not under adequate contraceptive protection
* Women who are pregnant or breast feeding
* Known history of drug-, medication- or alcohol abuse within the last 12 months preceding the study
* Participation in another study with an investigational product within less than one month prior to this study
* Simultaneous participation in a study with an investigational drug
* Presence of any disease likely to require procedures altering the schedule of the protocol
* Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator
* Patients with limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication
* Patients with any clinically meaningful renal, hepatic, respiratory or cardiovascular disease
* Patients who have previously been admitted to this study
* Patients who will not accept transfusions of blood products
Mechanisms of Ischemic Stroke in Cancer Patients

The purpose of this study is to better understand the causes of stroke in people with cancer. Active cancer increases the risk of stroke. The investigators do not know exactly why this occurs but one possible reason is that people with cancer may have thicker blood than people without cancer. Thick blood can sometimes cause blood clots to form in the heart, which can then travel to the brain and cause stroke. This study is being done to help figure out why this and other causes of stroke occur in people with cancer. The investigators expect that information from this study will help doctors to more effectively prevent and treat stroke in individuals with cancer.

This will be a prospective cross-sectional study to examine the unique mechanisms of ischemic stroke in cancer patients. Enrollment will occur at the NewYork-Presbyterian Hospital (NYPH)/Weill Cornell Medical Center (WCMC) and the Memorial Sloan Kettering Cancer Center (MSKCC). Measurements will occur at the NYPH/WCMC and MSKCC Neurovascular Ultrasound Laboratories, the MSKCC Central Laboratory, and the Sharp Laboratory at the University of California, Davis. Three groups of adult patients will be enrolled. Group 1 will consist of consecutive patients with active solid tumor cancer and acute ischemic stroke. Group 2 will be patients with acute ischemic stroke and no cancer. Patients in Groups 1 and 2 will be enrolled at 96 hours +/- 24 hours of stroke onset. Group 3 will include patients with active solid tumor cancer and no stroke. This group will allow us to confirm that differences between stroke patients with and without cancer are not simply incidental findings that can be expected in all cancer patients regardless of thrombotic status. Demographics, comorbidities, and stroke severity (for Groups 1 and 2 only) will be recorded on admission using a structured form. Study patients will undergo three facets of testing: 1) Transcranial Doppler (TCD) microemboli detection; 2) hematological biomarker testing; 3) peripheral blood leukocyte RNA gene expression analysis.

Eligibility Criteria:
Inclusion Criteria

* 18 years of age or older
* Active solid tumor cancer (for Groups 1 and 3 only)
* MRI confirmed acute ischemic stroke (for Groups 1 and 2 only)
* Available for blood draw at 96 hours (+/- 24 hours) from last known well time (for Groups 1 and 2 only) or within 2 weeks of enrollment (for Group 3)
* Available for TCD within 2 weeks of enrollment

Exclusion Criteria

* Primary brain tumor or hematological cancer
* Treatment with intravenous or intraarterial thrombolysis or mechanical embolectomy
* Platelets \< 50,000/mm3
* Hemodialysis within 14 days
* Active pregnancy
* Infection within 14 days per Infectious Diseases Society of America (IDSA) criteria
Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)

This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.

This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.

After screening, eligible subjects will be randomly assigned to 1 of 2 treatment sequences; CHS-1701 followed by Neulasta® (Sequence A) or Neulasta® followed by CHS-1701, Sequence B). Treatments will be spaced by a minimum of 6 weeks apart (but no more than 8 weeks). Subjects will be admitted to the Clinical Pharmacology Unit (CPU) on Day -1 (Period 1) and will be confined through Hour 96 postdose (a total of approximately 4.5 days and 5 nights). Blood samples will be collected at specified time points postdose for plasma PK and PD measurements and the subjects will be closely monitored for safety. Following discharge on the morning of Day 5 (Period 1) subjects will return to the clinic for additional PK, PD and safety follow up--daily through Day 9 and at stated interval time points thereafter.

The single dose of the alternate blinded study drug will be given after 6 (but no more than 8) weeks of observation and washout and the above procedures will be repeated (Period 2). A Follow up Visit will take place 41 (±1) days after the second dose.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female of ages 18 to 50 inclusive
2. Body weight \> 50 kg (110 lb.) and body mass index between 18 and 32 kg/m2 inclusive
3. Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination
4. Negative urine pregnancy test in women of childbearing potential

Exclusion Criteria:

1. Previous exposure to pegfilgrastim or filgrastim, or known allergy to PEG (polyethylene glycol)
2. Chemistry and hematology values outside protocol specified range
3. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder
4. History of chronic or acute respiratory illness within the past 4 weeks
5. Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation
6. No prescription or nonprescription drugs during the study
7. Participation in an investigational clinical study within 30 days prior to screening
8. Known or suspected allergic reaction to latex
Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L in Extraction of Lower First Primary Molars

parallel technique will be done where the investigator (will be blinded) will give one type on anesthesia then performing the extraction and evaluating the intraoperative pain ,the same procedure will be done for the other type of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-8 years.
* Medically fit (ASA I, II).
* Mentally capable of communication.
* Having a mandibular first primary molar tooth that require Extraction.
* Child must give assent prior to participation, as well as parental informed written consent.
* Body weight \>20 kg.
* it should be the first dental treatment to the child

Exclusion Criteria:

* Medically and mentally compromised children.
* Children without a history of prolonged bleeding, platelet disorders, hypersensitivity,
* History of significant behavior management problems.
* Patients having active sites of pathosis in the area of injection.
* Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
* Patients allergic to Articaine and/or Mepivacaine and/or sulfur
Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)


Eligibility Criteria:
Inclusion:

* Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of \>= 220 and \<= 450, normal laboratory parameters,
* are willing and able to give informed consent, and
* are able to self-inject or have a designee or healthcare professional who can inject the study medication.

Exclusion:

* History of certain types of cancer, diagnosis of ulcerative colitis,
* female or breast feeding subjects,
* surgical bowel resection(s) with in the past 6 months,
* history of listeria,
* human immunodeficiency virus (HIV),
* central nervous system demyelinating disease or untreated TB,
* history of a poorly controlled medical condition,
* unsuccessful response to infliximab or any anti-TNF agent use in the past.
The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation in Normotensive and Hypertensive Patients

To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in normotensive and hypertensive patients

It is known that anesthetic agents can influence the QTc. In addition, tracheal intubation during induction can stimulates sympathetic activity, which, as a results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in normotensive and hypertensive patients.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 50 years ASA class I-II female who received surgery with endotracheal intubation

Exclusion Criteria:

* emergency surgery electrocardiography abnormality diabetes mellitus end stage renal disease moderate to severe cardiac disease moderate to severe liver dysfunction
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants ≥18 and ≤49 years of age at the time of consent
* Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
* Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
* Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
* Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
* Known or suspected immunodeficiency or other conditions associated with immunosuppression
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
* Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention
Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus: the Living Well with Lupus Study

This research program aims to investigate the clinical, physiological, metabolic and molecular effects of lifestyle change in patients with systemic lupus erythematosus with high cardiovascular risk. This 6-month parallel-group randomized controlled trial aims to investigate the feasibility and efficacy of a newly developed lifestyle change intervention - through recommendations for structured and unstructured physical activity and healthy eating - on increasing physical activity level and improving eating habits. Potential effects of the intervention on cardiovascular and cardiometabolic risk factors, health-related quality of life, symptoms of anxiety and depression, sleep quality and immune function will be investigated. Gold-standard techniques and a variety of analyses will be performed to access the potential mechanisms involved in response to this intervention.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 65 years old diagnosed with systemic lupus erythematosus
* one or more high cardiovascular risk factors
* SLEDAI score ≤ 4
* Treatment with prednisone at a dosage \<10 mg/d and treatment with hydroxychloroquine in a stable dose

Exclusion Criteria:

* another rheumatic diseases (except for secondary Sjogren's syndrome)
* participation in structured exercise training programs and/or prescriptive diets
* illiterate or with diagnosed cognitive disorders or musculoskeletal impairments that potentially compromise understanding and participation in the intervention