cyrilzakka/clinical-trials huggingface dataset:
Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults

The "Safe Vehicle Engagement (SaVE)" trials are 3 parallel randomized clinical trials that aim to determine the impact of text messaging (SMS) vehicle safety interventions vs. weekly SMS vehicle safety self-monitoring alone on seat belt use, distracted driving and drink driving among young adults identified in the emergency department (ED) with risky vehicle behaviors.

The investigators propose to conduct 3 related randomized, controlled, parallel group, assessor-blind, superiority trials of 6-week text message interventions vs. SMS vehicle safety self-monitoring in young adult participants with risky vehicle behaviors. A total of 500 adult participants will be enrolled: 300 into Cohort 1 (seat belt); 100 into Cohort 2 (distracted driving); 100 into Cohort 3 (drink driving). Each SMS intervention will be designed to target a single risk behavior. The study is powered to show a difference of 15% in the percentage of subjects reporting seat belt use at week 8. Other cohort trials (i.e. distracted driving, drink driving) and outcomes will be exploratory.

Eligibility Criteria:
Inclusion criteria:

1) Adult participant (age ≥ 18 years \& ≤25 years)

1. Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat belt
2. Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used to type while driving and car was moving
3. Cohort 3: Any vehicle trip in past 2 weeks where individual reports driving a vehicle within 2 hours after consuming 2 or more drinks

Exclusion criteria:

1. Member of a protected population (prisoner)
2. Unable to provide informed consent
3. No plan to drive and/or ride in a vehicle in the next month
4. Non-English speaking
5. No personal mobile phone or planning on changing phone in next 3 months
Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC

This observational study is designed to assess the long term safety of the durvalumab treatment period including subsequent treatment period and demonstrate the efficacy of patients treated with durvalumab following chemoradiation therapy in the real world.

Study design: Prospective multi-center non-interventional cohort study Data Source(s): Medical records of patients who are treated with durvalumab following chemoradiation therapy Study Population: Patients prescribed and treated with durvalumab for unresectable stage III non-small cell lung cancer (NSCLC) at first time following chemoradiation therapy and who provide written informed consent.

Exposure(s): durvalumab Outcome(s): Summary of pneumonitis and adverse event special interest (AESI), progression free survaival (PFS), overall survaival (OS), Reasons of discontinuation of durvalumab treatment, Details of subsequent treatments after durvalumab Sample Size Estimations: 500 patients Statistical Analysis: Only descriptive analysis and no formal test

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy.
* Patients who provided written informed consent.

Exclusion Criteria:

* Patients who would join Post Marketing Surveyllance for durvalumab.
* Patients who would join any interventional clinical studies using unapproved drugs or off-label use of drugs from first diagnosis to the end of the durvalumab treatment
* Age \< 20
Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis

The purpose of this study is to evaluate the effectiveness of digital health management for intervention on Chinese population with head and neck vascular stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria of the clusters

   Hospitals with the qualification of "head and neck ultrasound center" in China.
2. Inclusion criteria for individuals

   * (1)Age ≥ 35 years old, with no restriction on gender.
   * (2)Patients with clinically diagnosed head and neck stenosis or occlusion, including mild, moderate or severe stenosis or occlusion of the carotid artery and mild, moderate or severe stenosis or occlusion of the intracranial artery.
   * (3)Ability to use a smartphone and have a mobile application installed on the handset.
   * (4)Subjects or their legal representatives agreed to the study and signed the project informed consent form.

Exclusion Criteria:

1. Exclusion criteria for the clusters

   The included centers did not have the capacity to undertake the trial.
2. Exclusion criteria for individuals

   * (1)Combination of severe systemic diseases such as respiratory failure, renal failure, gastrointestinal bleeding, coagulation dysfunction, malignancy, etc.
   * (2)Patients with a life expectancy of less than 2 years or who are unable to complete the study for other reasons.
Snack It Up for Parents: Interventions to Improve Children's Snacks

Influencing children's snacking habits has the potential to reap long-term rewards, yet few studies have focused on helping parents to provide healthier snacks for their children. The study tested the feasibility and preliminary effectiveness of parent interventions to improve snacks for children ages 8-12.

Objective. Influencing children's snacking habits has the potential to reap long-term rewards, yet few studies have focused on helping parents to provide healthier snacks for their children. The study tested the feasibility and preliminary effectiveness of parent interventions to improve snacks for children ages 8-12.

Methods. Parents of children enrolled in an out-of-school-time soccer program in a low-income school district (n 16) were recruited. A comparison of 3 randomly-assigned interventions was conducted: 4 parents received grocery store gift cards (Incentive); 7 received nutrition education videos with tip sheets (Education); and 5 received both (Combined). The interventions were assessed qualitatively by interviewing parents and quantitatively to determine motivation (psychosocial survey) and children's snack quality (web-based 24-hour recall).

Eligibility Criteria:
Inclusion Criteria:

* 18 year and older
* Must have a child enrolled in one of three designated soccer sites of the study and must agree to let their child take the online 24 hour recall (ASA24)
* Must have a child 7 years or older participating on a soccer team
* Must frequently buy groceries from Stop \& Shop (only if recruited for a study arms that involves grocery coupons)
* Must be literate in English or Spanish.

Exclusion Criteria:

* Failure to provide informed consent
Effectiveness of Imiquimod Topical Cream in Early Stage Cutaneous T-cell Lymphoma

This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).

The purpose of the study is to compare the safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage CTCL.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged ≥18 years.
2. Willing and able to give informed consent
3. Diagnosis of Mycosis Fungoides In cases with equivocal histological features, the diagnosis may be confirmed through the use of clonal T-cell gamma gene rearrangement, as detected by PCR amplification and primer sets specific for the T-cell receptor gamma chain genes.
4. Subjects must have at least one target lesion
5. Subjects will be able to comply with the study instructions, apply the study medication as directed and attend all visits.
6. Females of child-bearing potential must have a negative urine pregnancy test before randomization and must agree to use an adequate method of contraception (abstinence, condoms, hormonal therapy, barrier methods) during the study.
7. Patients must be otherwise healthy with an ECOG Performance status of 0 or 1.
8. The patient must not have had topical (2 weeks) or systemic therapy (4 weeks), radiotherapy (4 weeks) or phototherapy therapy (4 weeks) for Mycosis Fungoides within the stated number of weeks prior to start of treatment.
9. Eligible patients will be those who topical corticosteroid would be a preferred treatment and include patients newly diagnosed with stage IA, IB, or IIA disease, or those patients currently stable on therapy, in whom topical corticosteroids are being newly added to the regimen (i.e. recurrence or resistant lesions not currently treated with topical corticosteroids)

Exclusion Criteria:

To be eligible for inclusion in this study the subjects must not meet any of the following criteria:

1. Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
2. Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug.
3. Received any investigational drug or taking part in any clinical study within one month prior to this study.
4. Known reaction or allergy to test drug or excipient.
5. Presence of major medical illness or symptoms of a clinically significant illness that may influence the study.
6. Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk such as a history of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol.
7. Lesions on the genitals, axillae and face will not be selected for study treatment and evaluation.
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis

Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients/healthy control participants (age 18 or above) who can give their informed consent
* Suspected liver disease:
* non-alcoholic steatohepatitis
* alcoholic steatohepatitis
* autoimmune hepatitis
* primary biliary cholangitis
* primary sclerosing cholangitis
* inflammatory bowel disease
* polycystic ovary syndrome
* hereditary haemochromatosis
* chronic pancreatitis
* cystic fibrosis
* alpha-1 antitrypsin deficiency

Exclusion Criteria:

Patients with:

* malignant diseases
* viral hepatitis
* human immunodeficiency virus
* contraindications to liver biopsy
Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair

The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.

The management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. The ideal management is to effectively heal the fistula without compromising continence, avoid fistula recurrence, and quick recovery. Ligation of the intersphincteric fistula tract (LIFT) and LIFT reinforced with a bioprosthetic graft (BioLIFT) are two recently reported procedures that showed improved healing results. In the LIFT, Rojanasakul et al proposed to identify the fistula tract in the intersphincteric space and subsequent division and ligation of the tract, and the primary healing rate was 94.4%. The following studies reported slightly lower results, but the recurrence rate was as high as 18% to 28%. Ellis et al subsequently described a modified LIFT procedure (BioLIFT procedure) in which a bioprosthetic was placed in the intersphincteric plane to reinforce the closure of the fistula tract (BioLIFT procedure), and yielded a healing rate of 94% in 31 patients who had a minimum of 1 year of follow-up after their last treatment.

The investigators modified the LIFT procedure by combining LIFT with the technique of anal fistula plug. The bioprosthetic plug was placed into the fistula tract through the opening in the external sphincter to the external opening in the skin after LIFT procedure. The present study was designed to assess the preliminary results of LIFT-Plug technique prospectively.

The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects over eighteen years old or less than 65 years old.
* Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
* Clinical diagnosis of primary anal fistula categorized as trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).

Exclusion Criteria:

* Presence of horseshoe fistula.
* History of immunosuppression therapy/treatment within previous six months.
* Fistulas with active abscess, infection, or acute inflammation
* History of Choron's Disease
* History of Ulcerative Colitis
* History of HIV or other immune system disease
* History of collagen disease
* History of radiation to the anorectal region
* Allergies to pig tissue or pig products
* Religious or cultural objection to the use of pig tissue
Evaluation of an Apple Juice Drink With POs-Ca

The null hypothesis tested was that there are no differences in the taste palatability of the apple juices before and after adding POs-Ca.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult subjects
* No eating or drinking within 30 minutes before the start time of the trials
* No tooth brushing within 30 minutes before the start time of the trials

Exclusion Criteria:

* apple hypersensibility
HEMOTOL: Efficacy and Safety of Hemodialysis On-line Monitoring Devices on Hemodynamic Stability in Intensive Care Unit

The purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.

Acute kidney injury (AKI) is associated with high mortality and morbidity rates in critically ill patients despite advances in renal replacement therapy (RRT). Over the last few years, new devices in dialysis equipment, such as blood temperature and blood volume on-line monitors, have been developed to improve hemodynamic tolerance, and these new modalities have demonstrated their positive impact on decrease in intra-dialytic hypotension rate in chronic hemodialysis patients. In order to evaluate these new devices in critically ill patients with acute kidney injury we decided to conduct a prospective randomized controlled trial.

We based calculation of the sample size on a power analysis that assumed an expected decrease in intra-dialytic hypotension rate of 40% (from a crude intra-dialytic hypotension rate of 30% to 18%) in groups B and C, compared with group A. Analysis is done by intention to treat, according to prescribed new dialysis on-line monitoring devices.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Acute Kidney injury requiring intermittent hemodialysis

Exclusion Criteria:

* Age \< 18 years
* End-stage renal failure
* Inclusion in other protocol
* Absence of consent
Functional Imaging in the Acute Phase of Transient Ischemic Attacks

The aim of the study is to find a radiological biomarker of Transient Ischemic Attacks (TIA) thanks to functional Magnetic Resonance Imaging (fMRI) done within the 24 hour after symptoms onset.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted in for a transient neurologic deficit and suspicion of TIA of carotid circulation
* Prescription for conventionnal MRI

Exclusion Criteria:

* Contraindication to MRI
* Previous neurological disease (with lesions)
* Severe psychiatric disease
Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells

To evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cel

Psoriasis is a chronic and recurrent inflammatory skin disease and its histological features are characterized by epidermal hyperplasia, increased angiogenesis and immune cell infiltration. Psoriasis prevalence is about 0.1%-3%, affecting approximately 125 million people worldwide. In China, there are about 10 million psoriasis patients.

Human umbilical cord-derived MSC (huc-MSC) has many advantages for the treatment of immune disease. Because it was demonstrated that huc-MSCs are effective in modulating immune cells and treating diseases and it has low immunogenicity. Furthermore, huc-MSCs do not raise ethical issue for clinical applications.

Some experimental results and cases has showed that mesenchymal stem cell (MSC) can prevent or treat psoriasis. This clinical study is conducted to provide more data to evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cell.

Eligibility Criteria:
Inclusion Criteria:

1.Understanding the whole process of the study, voluntary participation and signed the informed consent; 2.18 Years to 65 Years old, Body Mass Index (BMI) between 18.5-35; 3.Diagnosed according to biopsy for Psoriasis vulgaris for more than 6 months and resistance to phototherapy, systemic therapy, or a combination of these therapies,BSA(body surface area)\>10%, PGA≥3 and PASI\>10 at baseline; 4. Patients participated in any stem cell therapy within 6 months;

Exclusion Criteria:

1. WBC(white blood cell count ) \<3.5x109/L, blood platelet count\<100x109/L, hemoglobin\<100g/L serum creatinine\>1.5 x ULN(upper limit of normal), bilirubin \> 1.5 x ULN(upper limit of normal), AST(SGOT,glutamic-oxalacetic transaminase)/ALT(SGPT,glutamic-pyruvic transaminase) \>2.0 x ULN(upper limit of normal);Either HIV-antibody(human immunodeficiency virus-antibody), HBV-antibody (hepatitis B virus-antibody ) or syphilis antibody is positive;
2. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history,Patients suffering from any acute or chronic infectious diseases, patients suffering from malignant tumor; Mental disorders, history of alcohol abuse, drug or other substance abuse;
3. Patients who have received systemic therapy within recent one month or topical therapy in two weeks;
4. Having a serious allergic history or being allergic to two or more than 2 kinds of food or drugs;
5. Pregnant women, or women who ready for pregnancy or lactating; Patients participated in any clinical trials within 3 months; Other cases which researchers believe that can not enroll.
Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing

The TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and has been shown to heal ulcers at a rapid rate in preliminary experience in patients with plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates will be determined clinically and by blinded, computer-assisted planimetry of digital images over a 12 week period. The pressure on the plantar surface will be measured via a pressure sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.


Eligibility Criteria:
Inclusion Criteria:

* Men or women \>18 years old
* One or more foot ulcers without clinical evidence of osteomyelitis
* Diagnosis of Diabetes Mellitus\*
* University of Texas Grade 1A, 1C, 2A, or 2C ulcer15
* ABI \>0.7 and Toe pressure \>30mmHg

Exclusion Criteria:

* Limited life-expectancy
* Wounds on calf or shin that would be in contact with the TAG Brace
* Gangrene, active infection
* Osteomyelitis of the foot with the ulcer
* Chronically bedridden/Non ambulatory
* Unable to keep research appointments
* Wide spread malignancy or systemically immunocompromising disease
* Ipsilateral revascularization procedure within the last 30 days.
* Unreliable, unwilling or unable to comprehend informed consent
Functional Outcomes of The Bobath Approach on Patients With Brain Tumors: Comparison With Stroke Patients

The aim of this study is to examine the functional recovery results of the Bobath (NDT) approach in patients with primary brain tumors and compare the results with those of stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* acute phase patients with brain tumor and stroke in after surgery

Exclusion Criteria:

* Modified rankin scale \<2
* High grade tumor
* Infratentorial tumor
* GCS\<14
* Rehabilitation session time\<3
* Second or more tumor surgery
* Second or more stroke
* Bilateral stroke
Optimizing the Number of Systematic COres During a MRI Target Biopsy

This is a multicentre, paired-cohort, prospective, controlled study. The patient with a suspicion of PCa and a concomitant positive mpMRI (defined as presence of one lesion PI-RADS ≥ 3) will receive a MRI-TBx (4 target cores). During the same session, subsequently to MRI-TBx, patient will receive a systematic sampling with 6-core S-Bx followed by 14-core S-Bx, for a total of 20-core systematic cores, in addition to 4 MRI-TBx cores. Procedure will be performed by the same operator. Each single core will be stored in a dedicated cassette and sequentially numbered. We hypothesize that the proportion of csPCa (defined as prostate cancer with Gleason score ≥ 3+4) detected by 6-cores S-Bx will be no less than that detected by 20-cores S-Bx, both performed in addition to MRI-TBx. Assessing the optimal number of systematic cores to take in addition to MRI-TBx cores in men undergoing a MRI-TBx would provide a useful clinical information for every day clinical practice. Moreover, the possibility to decrease the number of systematic cores taken during a MRI-TBx, hence reducing the overall number of cores taken during a biopsy, would reduce the length of the diagnostic procedure, potentially reduce the probability of infections/sepsis and reduce the overdiagnosis of clinically insignificant PCa.


Eligibility Criteria:
Inclusion Criteria:

* Male patients, aged between 18 and 80 years old with suspicion of prostate cancer
* Presence of a positive mpMRI of the prostate (visible lesion PI-RADS ≥ 3)
* Serum PSA ≤ 20ng/ml
* Suspected stage ≤ T2 on rectal examination (organ confined prostate)
* Fit to undergo a prostate biopsy
* Able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Prior positive prostate biopsy
* Prior treatment of the prostate
* Prostate volume \<30 ml at mpMRI of the prostate
* More than one lesion at mpMRI of the prostate
* Contraindication to prostate biopsy