cyrilzakka/clinical-trials huggingface dataset:
WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt

The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).

R61 Phase: In this "proof-of-concept" phase, interventionists will administer 12 weeks of WellPATH-PREVENT in 40 middle-aged and older adults who have been discharged after being hospitalized for suicidal ideation or suicide attempt. The interventionist will help the patient incorporate the appropriate data (i.e., triggers, negative emotions, cognitive reappraisal techniques) into the tablet, train the patients on how to use the tablet, and coach them during the 12 weeks. There will be 4 assessments: At study entry (admission/during hospitalization), hospital discharge, 6, and 12 weeks. An EEG will be conducted upon entry into the study, at Week 6, and at Week 12.

R33 Phase: 75 middle-aged and older adults who have been recently discharged after a hospitalization for suicidal ideation or attempt will be recruited and randomized to an optimized version of WellPATH-PREVENT (Week 6 and Week 12 duration based on R61 results) or to Attention Control-Usual Care with a tablet (AC-UC). There will be 5 assessments: At study entry (admission/during hospitalization), discharge, 6, 12 and 24 weeks. Participants who exit the study prior to completion will be invited to have an assessment before termination as close to the scheduled time point as possible. Psychiatrically re-hospitalized participants will not be dropped from the study but will have an additional assessment and will continue the assessments as scheduled based on their initial hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* 50-90 years old
* Diagnosis (based on a modified SCID-5 Clinical Trials Version to assess DSM-5 diagnoses): Any DSM-5 except: current diagnosis of Psychotic Disorder; diagnosis of Dementia
* Recent hospitalization for suicidal ideation or suicide attempt; at hospital admission, Columbia Suicide Severity Rating Scale (CSSR-S) ≥ 2, "Non-specific Active Suicidal Thoughts."
* We will also include patients on psychotropics and on after-care community psychotherapy.

Exclusion Criteria:

* Current diagnosis of Psychotic Disorders; Diagnosis of Dementia
* Cognitive Impairment (MMSE ≤ 24)
* Acute or severe medical illness (i.e., delirium; decompensated cardiac, liver or kidney failure; major surgery; stroke or myocardial infarction during the three months prior to entry
* Aphasia, sensory problems, and/or inability to speak English.
Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor

This is a Phase I/II clinical trial for patients with r/r Non-Hodgkin's Lymphoma relapsed after chimeric antigen receptor T cells infusion. The purpose is to evaluate the safety and efficacy of the treatment with chidamide in combination with decitabine.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion.
2. 18 to 65 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable new lesion \>1.5cm as defined by lymphoma response criteria.
6. Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day 1.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. Intrathecal opioid administration is an attractive analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close to the structures of the central nervous system where the opioid acts.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 25 to 35kg/m².
* American Society of Anesthesiologist (ASA) physical status I or II.

Exclusion Criteria:

* patient's refusal
* Altered mental status
* Known allergy to study drugs (bupivacaine or morphine)
* Local infection at site of puncture.
* Known case with any pulmonary disease
* Known case with Obstructive sleep apnea (OSA)
* Coagulopathy and /or thrombocytopenia
* Chronic pain
* Severe hepatic or kidney impairment
Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma

This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized carbon-ion radiotherapy (CIRT). For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups.

This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized CIRT with a dose of 63 gray equivalent (GyE) in 21 fractions (fx). This regimen was obtained from our previous phase 1 (dose escalation) study. For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups. The secondary endpoints include 2-year overall survival (OS), local progression-free survival, regional progression-free survival, distant metastasis-free survival, toxicities and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 17-70 years.
* Pathologically diagnosed as WHO type 2/3 nasopharyngeal carcinoma.
* Failed previous definitive radiotherapy at least 6 months ago.
* Only had 1 previous course of radiotherapy.
* Eastern Cooperative Oncology Group score: 0-1.
* Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil \> 2000/mm\^3; 2) platelet \> 100,000/mm\^3; 3) total bilirubin \< 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase \< 1.5 upper limit of normal; 5) SCr \< 1.5mg/dl; creatinine clearance rate \> 60ml/min.
* Willing to accept adequate contraception for women with childbearing potential.
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.

Exclusion Criteria:

* Presence of distant metastasis.
* Without measurable lesion.
* Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
* Accompanied with severe major organ dysfunction.
* Presence of mental disease that may influence the understanding of informed consent.
Improving Varenicline Adherence and Outcomes in Homeless Smokers

the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.

Despite significant declines in cigarette smoking rates among adults in the United States in the last few decades, smoking rates remain high among poor and underserved populations. One underserved group is the 4 million homeless persons in the US among whom cigarette smoking rate is an alarming 70% or more; these rates are 3 times higher than national average. Two of the three leading causes of death among homeless persons, heart disease and cancer are tobacco related.2, 3 Despite very high smoking prevalence and disease burden in this population smoking cessation research have not been extended to the homeless. Recent studies including data from our research team show a considerable degree of readiness to quit smoking by homeless smokers and that nicotine replacement therapy (NRT) plus counseling show promise. However, homeless persons face many challenges that may constitute barriers for them to adhere to smoking cessation treatments even if such treatments have been proven effective in the general population. In order to reduce smoking-related health disparities within this underserved population, it is critical that cessation interventions including strategies to improve treatment adherence be developed to include homeless smokers. The primary aim of this study is to assess the effects of adherence-focused motivational interviewing (MI) to help homeless persons quit smoking.

Recruitment and retention will be enhanced by use of bus passes for transportation, debit cards, attractive intervention materials, collaboration with homeless shelters, and advice from a community advisory board. If successful, this study will provide a model for how to overcome barriers to cancer prevention services among homeless persons. It will also provide the impetus for policy changes directed at increasing homeless persons' access to smoking cessation pharmacotherapy and treatment.

Eligibility Criteria:
Inclusion Criteria:

* currently homeless
* smoke 5 or more cigarettes per day
* smoked 100 cigarettes in lifetime
* aged 18 years or older

Exclusion Criteria:

* unstable mental illness
* pregnancy
* current history of psychoactive or alcohol dependence or psychotic disorder
* cognitive impairment
Comparative Trial of Standard Versus Low-dose Peg-Interferon Plus Ribavirin in the Treatment of Chronic Hepatitis C

The purpose of this study is to evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic Hepatitis C. Must be infected with genotype 1b viruses

Exclusion Criteria:

* Hemoglobin levels\<8.5g/dL,
* Platelet counts\<50,000/mm3,
* Total polymorphonuclear counts\<1000/mm3
* Pregnancy,
* Renal dysfunction,
Spironolactone and Insulin Resistance in Chronic Heart Failure (CHF)

The purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

Diuretics is useful in CHF patients. On the other hand, they deteriorate glucose metabolism. Therefore, the purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

Eligibility Criteria:
Inclusion Criteria:

* chronic stable heart failure

Exclusion Criteria:

* renal dysfunction or under treatment with antidiabetic agents
Prospective Quality Improvement Project for High-Risk Diabetes Patients

Diabetes is the most important comorbidity of tuberculosis patients in Taiwan, and 1/4 of tuberculosis patients also It is a diabetic patient, and the treatment of latent tuberculosis infection is currently an important policy of the Taiwan Disease Control Agency One, because babies are prone to encounter difficulties in the early stages, because of the spread of Australian patients in the community, The Department of Disease Control encourages patients with diabetes to receive screening and treatment for latent tuberculosis infection.

Diabetes mellitus is the most prevalent comorbiditiy for patients with active tuberculosis in Taiwan. More than one fourth of the patients with incident tuberculosis has diabetes mellitus. The latent tuberculosis infection treatment is recommended by the Centers of Disease Control (CDC) of Taiwan to halt the transmission of tuberculosis in the community. Considering a relatively long delay in diagnosis of tuberculosis in clinical practice, eliminate the dormant tuberculosis germs a the stage of latent infection is the most cost-effective strategy to avoid tuberculosis transmission. The population with diabetes mellitus and inadequate blood sugar control are at increased risk of latent tuberculosis infection and activation and are encouraged to undergo latent tuberculosis screening and treatment. However, the anti-tuberculosis agents could have significant drug-drug interaction with the drugs used for diabetes mellitus control. The extent of its impact on blood sugar is still unclear. We aim to investigate the fluctuation of blood sugar during latent tuberculosis treatment with continuous subcutaneous sugar monitoring device to evaluate the possible associated risk of hyperglycemia or hypoglycemia to enhance treatment safety. Inadequate blood sugar control is the root for immune dysfunction and render the patients vulnerable to infectious diseases. Hence, improvement in the blood sugar control not only leads to a better immune function to avoid tuberculosis infection but also reduce the risk of progression for cardiovascular and renal disorder. The present study proposed a protocol of 12-week aggressive blood sugar control and education program using phone call to improve the blood sugar control and life quality. Furthermore, to evaluate the efficacy of anti-tuberculosis treatment for latent tuberculosis, we propose to evaluate the mycobacteria-specific antigen immune response by using the interferon-gamma releasing assay before and after anti-tuberculosis treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients had a record of glycated hemoglobin (HbA1C%) greater than 9% in the past year.

Exclusion Criteria:

* Be younger than 20 years old.
* Unconsciousness or severe dementia, unable to conduct quality of life questionnaire assessment.
Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction

Researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be between 13 and 40 years old
* Subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction
* Subjects must be able to understand study procedures and comply with them for the entire duration of the study
* Subjects must have normal contralateral limb strength

Exclusion Criteria:

* Subjects with any personal history of deep vein thrombosis or with such history in their immediate family
* Subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading
* Subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg
* Subjects with an inability or unwillingness of individual or legal guardian to give written informed consent
Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure

Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Different patients experience different pain intensity. This suggests that there may be genetic variants that make some patients susceptible to analgesic failure. Using blood samples from patients, the investigators are going to analyze the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be involved in analgesic failure.


Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 70 and Age ≥18
* Selective operation lung section with video-assisted thoracic surgery (VATS)
* III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I
* Patients informed and agreed to join the study

Exclusion Criteria:

* Abnormal function of liver and kidney
* Allergic- dependence history of alcohol, opioids and Local anesthetics
* No noncompliance
* Mental disease history，language communication disorder，cicatricial diathesis
* Underweight or overweight（BMI\<18 or \>30)
* Patients not suitable for clinical subjects for other reasons
* Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24hours before the operation.
* History of previous abnormal anaesthesia
* Women during pregnancy or lactation
Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women

To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena®


Eligibility Criteria:
Inclusion Criteria:

1. Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit.
2. Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL.
3. Naturally or surgically postmenopausal with or without an intact uterus.

Exclusion Criteria:

1. Have history of or positive test results for HIV or hepatitis B or C.
2. A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition.
3. Receiving or have received chronic opioid therapy within 12 months.
4. Unwilling to stop taking/using:

   * pain medication.
   * topical analgesic or anti-inflammatory treatment. Topical analgesics must be washed out by at least 72 hours in the areas to be treated before randomization.
5. History of alcohol abuse (regularly drinks \> 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months.
6. Currently taking any estrogen/progesterone hormone replacement therapy (HRT).
7. History of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or any of the constituents of the study medications or history of any drug hypersensitivity or intolerance.
8. Poorly controlled diabetes (Hgb A1C \>8).
9. Current or history of thrombosis or thromboembolic disorders.
10. Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years.
11. Any current or recent (within previous 12 months) vaginal bleeding.
12. Uncontrolled hypertension.
13. A chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain.
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)

This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase.


Eligibility Criteria:
Inclusion Criteria:

* Must be ≥18 yrs old on the day of signing informed consent
* Diagnosed with Primary Insomnia
* Good physical and mental health
* Participant ≥65 yrs old score at least 25 on the Mini Mental State Examination
* A female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception
* Reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)
* Reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1
* Regular bedtime is between 9 pm-1 am
* Willing to refrain from napping while in study
* Able to read, understand and complete questionnaires and all diaries
* Willing to limit alcohol, caffeine, and nicotine consumption while in the study
* For a portion of participants: Must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory

Exclusion Criteria:

* Female participant is pregnant and/or breastfeeding at Prestudy visit, or expecting to conceive while in study
* History or diagnosis of another sleep disorder
* Difficulty sleeping due to a medical condition
* History of a neurological disorder
* History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication
* Ongoing depression
* History of substance abuse or dependence
* History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Prestudy Visit
* Taking certain prohibited medications
* Consumption of the equivalent of \>15 cigarettes a day
* History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Participant is considered morbidly obese
* Previously randomized in another investigational study of suvorexant
Lateral Neck Flexor Endurance and Hyperlaxity

The lateral neck flexor endurance test has been proposed to assess for unilateral muscular deficits. It is not known if individuals with hyperlaxity have different muscular endurance than individuals without hyperlaxity.

Thirty individuals with systemic hyperlaxity as determined with the Beighton scale will be assessed for lateral neck flexor endurance and compared to age and gender matched controls. Basic demographic information will be collected, and all individuals will report Neck Disability Index (NDI) and Numeric Pain Rating Scales (NPRS) for their neck, as well duration of any neck pain. All participants will then undergo testing of lateral neck flexor muscle endurance, repeated twice on each side. Average hold times will be compared for individuals with hyperlaxity (5 or greater on Beighton scale) and the healthy age and gender matched controls. Analysis will also include covariates of NDI scores, pain scores, and chronicity of symptoms.

Eligibility Criteria:
Inclusion Criteria:

systemic hyperlaxity of 5 or greater on Beighton Index, healthy age/gender matched controls

Exclusion Criteria:

* neck pain that spreads into the arms;
* whiplash injury within the last 6 weeks;
* diagnosed neuropathy or other nervous system disorders;
* a history of spinal surgery in their neck;
* fibromyalgia;
* insulin dependent diabetes;
* involved in legal activity regarding neck pain