cyrilzakka/clinical-trials huggingface dataset:
Expressive Interviewing Agents to Support Health-Related Behavior Change

Expressive writing and motivational interviewing are well-known approaches to help patients handle stressful life events. While these methods are often applied by human counselors, it is less well understood if an automated approach can encourage behavior changes in patients. This study presents an automated writing system and evaluates its impact on individual behavior related to the COVID-19 pandemic. The investigators developed a rule-based dialogue system for "Expressive Interviewing" to elicit writing from participants on the subject of how COVID-19 has impacted their lives. In May-June 2021, the investigators randomly assigned online participants (N=151) to the Expressive Interviewing task and a control condition. The investigators examined their behavior with a survey before the intervention, immediately after, and two weeks after. In aggregate, task participants experienced a significant decrease in stress in the short-term (\~23% decrease, p \< 0.001) and no significant changes in longer-term outcomes compared to the control group. Within the task, participants showed different outcomes based on their writing. Participants who wrote with more anxiety-related words showed a greater short-term decrease in stress (R=-0.264, p\<0.001), and those who wrote with more positive emotion words reported a more meaningful experience (R=0.243, p=0.001). For longer-term effects, participants who wrote with more lexical diversity underwent an increase in social activity (R=0.266, p\<0.001). Expressive Interviewing can generally help with mental health in the short term but not longer-term, and participants' writing choices may make a difference in outcomes. While there were no significant long-term effects observed, the positive short term effect points to potential future directions with a series of Expressive Interviewing interventions for longer-term effects.


Eligibility Criteria:
Inclusion Criteria:

* Using Prolific platform as crowd worker
* Living in United States

Exclusion Criteria:

* Participating in another condition of the same study
Evaluation of Using Platelet-Rich Fibrin in Adult Pulpotomy

The goal of this interventional randomized clinical trial is to evaluate the use of platelet rich fibrin in full pulpotomy in mature adult teeth.

The main questions it aims to answer are:

1. Does the use of platelet rich fibrin in complete pulpotomy in mature permanent teeth will raise the success rate of full pulpotomy of adult teeth?
2. Does the use of cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs?

Participants will be asked to do the following:

* Receive the pulpotomy treatment of their target tooth.
* Record the pain score in the pain assessment chart.
* Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target tooth. Researchers will evaluate the usage of platelet rich fibrin in performing the pulpotomy procedure of adult teeth and if cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age: 25-35 years
2. Mature permanent premolar teeth with two separate roots.
3. Clinical diagnosis of irreversible pulpitis.
4. Patients without existing medical condition.

Exclusion criteria:

1. Immature teeth.
2. Non-restorable teeth.
3. Non-vital Teeth.
4. Uncontrolled pulpal bleeding.
5. Periodontally affected teeth.
Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers

The goal of this small pilot study is to test the feasibility of combining a three-month intervention of working with a community health worker (CHW) to address social risk factors for patients prior to beginning a group weight management program for childhood obesity -- Promoting Health in Teens and Kids (PHIT Kids)


Eligibility Criteria:
Inclusion Criteria:

* Family must have one major social risk factor on the Protocol for Responding to \& Assessing Patients' Assets, Risks \& Experiences (PRAPARE) of the 14 modifiable risk factors
* Child aged 8 through 12 years of age
* Child with BMI% at 85th percentile or higher and less than the 120% of the 95th percentile (overweight or class 1 obesity)
* Child must live with parent/guardian at least 5 out of the 7 days on average (70% of the time)
* Child and parent able to speak English

Exclusion Criteria:

* Child on medications known to cause ongoing weight gain (e.g., atypical anti-psychotics, chronic prednisone, insulin)
* Child on other medications know to affect weight if dose and BMI z-score has not been stable for 3 months.
* Diabetes or other disease that has a significant effect on diet, physical activity, or ability to take part in trial activities besides obesity (does not included treated or mild depression or anxiety, limited food allergies or mild physical activity limitations)
* For parents: new MI, stroke or cancer diagnosis (excluding localized skin cancers) in past 6 months, history of bariatric surgery within the past 3 years, pregnancy in last 6 months or planned within 1 year
* Child or parent has significant developmental or cognitive impairments or other significant medical issue that would interfere with ability to participate or complete assessment
* Parent or child has significant physical limitation
* Parent/child planning to move to from Children's Mercy Kansas City (CMKC) service area
Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.

Oxaliplatin is widely used in GI cancer. Neutropenia and neurotoxicity are the most common adverse effects of oxaliplatin which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity.The continuous sense and/or motor abnormal reduce the quality of life. To date, there is no a drug to treat oxaliplatin induced neurotoxicity. Monosialotetrahexosylganglioside(GM) is a component of membrane of nerve cells. Previous phase II clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity (OIN). But it did not investigated for curing OIN in randomized control trial. A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for treatment OIN at GI cancer. Investigators design this randomized phase III placebo-controlled trail to identify the effect of monosialotetrahexosylganglioside sodium injection as a treatment agent for OIN. Investigators found 2.5% patients of grade 2 or more serious OIN would relieve with 3 months(data not published). Investigators assume monosialotetrahexosylganglioside can reduce neurotoxicity by 30%. At the level of power 0.8, the sample size is 160 with 10% dropout. If there is no dropout, the trial will be terminated at 144 events occur.The board of Tianjin cancer hospital has permitted the trial and will monitor the whole process of this study. All data will be submitted to the department of clinic trials at Tianjin cancer hospital.The statistics specialist is participating this design and will afford help for data analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients shall have normal organic function such as liver function, Cardiac function and renal function;
2. male or female age \>18 years old;
3. diagnosis GI cancer with histology;
4. Chronic neurotoxicity grade is 2 or more
5. Karnofsky Performance scores should be 80 or more
6. patients are in oxaliplatin-based chemotherapy courses or no more than 21 days after last oxaliplatin usage for patients who will discontinue oxaliplatin usage.
7. without uncured tumor except GI cancer,
8. Patients should be expected to live no shorter than 3 months

Exclusion Criteria:

1. patients who is receiving anti-neurotoxicity treatment;
2. WBC\<4.0×109/L，ANC\<1.5×109/L,PLT\<100×109/L，Hb\<90g/L,TBIL\>1.5Limitation;BUN）\>1.5Limitation；Cr）\>1.5Limitation；ALT or AST\>2.5Limitation（without liver metastasis）；ALT or AST）\>5Limitation（with liver metastasis）;
3. heart dysfunction;
4. brain metastasis with symptoms;
5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
6. in situation of oxaliplatin-based chemotherapy progressed, the next chemotherapy regime should not contain agents which will cause neurotoxicity (such as paclitaxel and cisplatin)
Anorexia in Children With Burn Injury and the Reactions of the Immune and Endocrine Systems

Anorexia in children with burn injury is a common phenomenon. The study is searching for the origin of the anorexia in those children. The study correlates between the level peptides of the immune and the endocrine systems and the length of the anorexia.

Burn injury lead to hypermetabolic set to heal the damaged tissue.Burn healing uses high energy consumption and as consequence is highly There is a huge activation of the endocrine system and immune system resulting a proinflamtory status.

The nutrition component has an important role in the burn healing process by reducing the healing time and also in the quality of the scar tissue. It's been observed that many burn injury patients are suffering from anorexia. Since we know pro-inflammatory status modulate satiety rises the question is there a correlation between the level peptides of the immune and the endocrine systems to anorexia in children with burn injury.

Catecholamines serum concentrations rise following a burn injury. These hormones have an important role in determining the basal metabolic rate (BMR). During the healing process the levels of growth hormone (GH) and Insulin like growth factor I (IGF-1) are reduced. Previous studies show a correlation between these lower levels and Interleukins and cytokines such as Tumor Necrosis Factor (TNF) Interleukin-6 (IL-6). Additional hormones, which are relevant, are cortisol and insulin. Cortisol levels are very high after severe burn injuries for a long period. insulin sensitivity state also has an important role in the healing process.

TNFa and IL-6, which are inflammatory factors, found to have significantly elevated serum concentrations during the healing process. They are also known to be reducers to GH sensitivity and causes anorexia.

This study will show the connection between the immune and the endocrine systems to the burn healing process and anorexia by examining the level of hormones, interleukins and neuropeptide during the burn healing. our goal is to try and improve the treatment in children with burn injury by nutritional or drug intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age below 16 years
* Abilty to feed yourself during hospitalization
* Gaining consciousness during hospitalization
A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil

The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences following a mass vaccination campaign in the city of Toledo in Southern Brazil.

Individuals aged 12 years or older who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 will be classified as cases, and those with negative PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of one year by means of structured telephone interviews.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 years old;
* Resident of Toledo city;
* Seeking care in the public healthcare system with symptoms suggestive of COVID-19 defined as follows: 1) ARI symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
* Nasal sample for SARS-CoV-2 diagnosis obtained as standard of care.

Exclusion Criteria:

* SARS-CoV-2-directed antiviral treatment within the past 30 days;
* COVID-19 monoclonal antibody therapy within the past 90 days;
* COVID-19 convalescent serum therapy within the past 90 days;
* Lack of consent to participate.
An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform

The purpose of this study to pilot test an accessible and inclusive artificial intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4CHRON) for health-related quality of life for adults with impaired mobility and chronic medical conditions.

The AI4CHRON study will use a four-arm randomized control trial design. Eligible and consented participants will be assigned to one of four groups: 1) Scheduled coaching calls with gamified rewards, 2) Scheduled coaching calls with rewards independent of gamification, 3) No scheduled coaching calls with gamified rewards, and 4) No scheduled coaching calls with rewards independent of gamification. The active intervention period will be six months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of heart disease, chronic lung disease, or Type 2 diabetes
* Living with a permanent physical disability (i.e., spina bifida, multiple sclerosis, stroke,)
* Have the ability to converse in and read English
* Availability of a smartphone or computer

Exclusion Criteria:

* Current enrollment in any structured intervention
* Severe cognitive impairment
* Severe untreated depression in the past 6 months
* Major cardiac event in the past 12 months
* Uncontrolled blood pressure
* Resting tachycardia
* Renal failure
* Severe peripheral neuropathy
* Active treatment for cancer in the past 12 months
* Having both visual and hearing impairments (either of them is fine)
Regulatory Post Marketing Surveillance Study on YAZ

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects

  * requesting contraception
  * suggesting PMDD by Physician who are also requesting contraception
  * with acne who are also requesting contraception
* Age: 18 - 50 years
* Women who is prescribed YAZ first, during study period

Exclusion Criteria:

* Women who are contraindicated based on the label of YAZ

  * Presence or a history of venous or arterial thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
  * Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
  * History of migraine with focal neurological symptoms
  * Diabetes mellitus with vascular involvement
  * The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
  * Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
  * Presence or history of severe hepatic disease as long as liver function values have not returned to normal
  * Severe renal insufficiency or acute renal failure
  * Presence or history of liver tumours (benign or malignant)
  * Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
  * Undiagnosed vaginal bleeding
  * Known or suspected pregnancy
  * Hypersensitivity to the active substances or to any of the excipients
Use of Naltrexone in a Clinical Setting

This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence (within the past 3 months).
* Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse.
* Must be able to provide an informed consent.
* Consent to random assignment and be willing to commit to possible medication treatment and research follow-up.
* Must be eligible for treatment at the Dorchester Alcohol and Drug Commission.

Exclusion Criteria:

* Meets criteria for opiate dependence.
* Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion.
* Hepatocellular disease.
* Women who are pregnant, nursing, or not practicing an effective means of birth control.
* Currently being prescribed naltrexone.
* Known sensitivity or allergy to naltrexone.
Ceftriaxone in Non-neutropenic Fever

This is a retrospective chart review of all patients cared for at Monroe Carell Jr. Children's Hospital at Vanderbilt including the following:

* patients between 2007-2009 with malignancy, Langerhans cell histiocytosis (LCH) or hemophagocytic lymphohistiocytosis (HLH) and a central venous catheter who were under 23 years of age at time of diagnosis in order to ascertain the associated symptoms, management and outcome of all episodes of non-neutropenic fever.
* to identify a subset of low-risk patients that can be safely managed without use of empiric antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with malignancy, Langerhans cell histiocytosis,or hemophagocytic lymphohistiocytosis from 2007 through 2010
* Under 23 years at time of diagnosis of malignancy, Langerhans cell histiocytosis,or hemophagocytic lymphohistiocytosis
* Treated at Monroe Carell Jr. Children's Hospital at Vanderbilt for aforementioned diagnosis from 2007 through 2012
* While on immunosuppressive therapy with a central venous line in place had at least one documented episode of fever (defined as ≥ 38.0°Celsius orally for over 30 minutes or ≥ 38.3°Celsius orally x1).

Exclusion Criteria:

* Does not meet all inclusion criteria as stated above
REVEAL Study: Vessel Healing After Angioplasty

To address early vessel healing and thrombus formation after deployment of three distinct groups of stents

A prospective, randomized study providing new evidences on early vessel healing and thrombus development after stenting with different devices.

Eligibility Criteria:
Inclusion Criteria:

* Lesion length ≤ 20 mm
* Two significant short lesions

Exclusion Criteria:

* Life expectancy \< 1 year
* Left ventricular ejection fraction (LVEF) \<30%
* Chronic kidney disease
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations.

Approximately 1140 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12 -75
2. Documented physician-diagnosed asthma.
3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
4. Morning pre-BD FEV1 value of ≥40 and \<80% value (\<90% for patients 12 to 17 years of age) of their PNV.
5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1
6. ACQ-6 score ≥1.5

Exclusion Criteria:

1. Pulmonary disease other than asthma
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant or breastfeeding
5. History of cancer
6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
7. Previous receipt of tralokinumab
Opioid Sparing Potential of Light-Induced Analgesia

This is a pilot trial testing the potential opioid-sparing analgesic effect of a novel non-pharmacological treatment using visualized light spectrums. Preclinical findings have shown such treatments to alter pain perception.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for thoracic surgery for which post-operative opioid PCA is anticipated (Acute Pain group) OR currently treated with opioid therapy for fibromyalgia (Chronic Pain group)
* 18 years of age and older
* Able to wear study eyeglasses for at least 4 hours per day
* Agree to participate and provide written informed consent and HIPAA authorization

Exclusion Criteria:

* None