cyrilzakka/clinical-trials huggingface dataset:
The Teachable Moment: Screening and Brief Intervention for Admitted Trauma Patients

The American College of Surgeons now requires screening for alcohol use in trauma centers. The purpose of this research study is to provide information about the best screening and treatment methods. The investigators hope the findings will provide information that will improve healthcare by reducing problems related to risky alcohol use. The trauma team is conducting a comparison of two different ways of talking about alcohol use. Participants will be randomized into one of the two study groups.

The goal of this study is to guide further policy development regarding effective alcohol screening by: (a) comparing the effectiveness of two new, shorter screening tools for risky drinking patterns with the longer screening tool in current use; (b) assessing the outcomes of two different brief counseling interventions (BIs) with trauma patients screened to have risky drinking behaviors; and (c) examining the impact of the implementation of this new policy in a Level I Trauma Center.

The Specific Aims will be accomplished by:

1. Screening patients who are admitted to the Trauma Center, and conducting BIs for all who screen positive;
2. Collecting formative qualitative data regarding participants' perceptions of benefits of drunken states, their individual risks, and perceived healthier alternatives;
3. Collecting quantitative data (injury severity score and hospital length of stay) and correlating these data with patient demographics and responses on the different screening methods;
4. Collecting follow-up data by telephone on self-reported alcohol use and trauma recidivism, using an interviewer-administered assessment;
5. Collecting data on trauma recidivism from ED data, publicly available records, and patient self-report at 6-month telephone follow-up;
6. Surveying trauma staff and physicians at three intervals regarding the process of implementing the new ACS policy, any perceived difficulties, and the perceived impact

Eligibility Criteria:
Inclusion Criteria:

* Inpatient on trauma service
* 18 years or older
* Speaks either English or Spanish

One or more of the following:

* Patient answered yes to either admission screening question
* Patient has a positive BAL of less than or equal to 79 and also has a positive Audit score (men greater than or equal to 8; women greater than or equal to 4)
* Patient has a BAL of 80 or higher
* patient has no record of a BAL on file and they have a positive Audit score

Exclusion Criteria:

* Patient unable or unwilling to provide informed consent
* Patient refusal contact at six months
* Patient has a positive BAL of less than or equal to 79 and negative AUDIT score
* Patient deemed unable to complete a BI
Comparison of The Effects of Virtual Balance Training and Conservative Rehabilitation Therapy in Stroke Patients

The study aimed to assess the effects of a virtual balance training program using the Thera-Trainer Balo (TTB) device along with conservative rehabilitation program on the clinical findings; standing, stepping, walking and balance measures; and activities of daily living in patients with stroke.

Stroke is one of the leading causes of death and disability worldwide. Approximately 71% of stroke cases occur as a result of ischemic infarcts. Most survivors of stroke experience gait and balance disorders that increase the risk of falling.

It has been shown that the functional recovery of patients with stroke is adversely affected and length of hospital stay during the rehabilitation program, particularly in those with severe balance disorders.

Virtual reality technologies are currently employed to accelerate functional recovery in patients.

A total of 30 patients were included in the study. The patients were randomized into two groups with 15 patients in each group by simple randomization.

Group 1 received the conservative rehabilitation program, whereas Group 2 received a balance training program using the Thera-Trainer Balo (TTB) device along with the conservative rehabilitation program.

Patient information regarding the age, gender, hemiplegic side, stroke duration, and type of ischemia were recorded. The stage of motor recovery according to Brunnstrom, spasticity based on the modified Ashworth scale, ambulation ability based on the Functional Ambulation Scale (FAS), quality of life based on the Short Form-36 (SF-36) scale, and balance-coordination status based on the Berg Balance Scale (BBS) were assessed at the beginning of the treatment and at the endpoint of the 8 week treatment. Moreover, evaluations were made with static and dynamic postural stability tests.

The study aimed to assess the effects of a virtual balance training program using the Thera-Trainer Balo (TTB) device along with conservative rehabilitation program on the clinical findings; standing, stepping, walking and balance measures; and activities of daily living in patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

* patients who had a cerebrovascular accident at least 6 months before the study,
* patients had the first unilateral hemiparesis attack, could stand with or without assistance,
* patients had no contraindications for walking.

Exclusion Criteria:

* patients with a history of neurological diseases,
* a mini-mental test score of \<24,
* severe spasticity at the lower extremity with grade 4 and unilateral neglect, and musculoskeletal diseases such as amputation and severe arthritis, which limits walking,
To Validate Changes in Knowledge, Attitudes and Practices (KAPs) Related to the Know Your OQ Initiative and to Understand the Readability, Comprehension and Ease of Use of the Know Your OQ Quiz

To validate changes in knowledge, attitudes and practices (KAPs) related to the KnowYour OQ initiative and to understand the readability, comprehension and ease of use of the Know Your OQ quiz

Quantitative analysis will be carried out for changes in knowledge, attitudes and practices(KAPs) after the exposure to the Know Your OQ™ intervention. Qualitative and quantitative analysis will becarried out for readability, comprehension and ease of use of the Know Your OQ™ quiz.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form.
* Male and female subjects aged 18-65+ years old
* Availability for the duration of the study
* English or Spanish fluency
* Access to laptop, tablet or computer with internet/data connection

Exclusion Criteria:

* Not present at NAHn Convention
A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash

This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants enrolled in the study will be treated twice daily with metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The anticipated time on metronidazole treatment is less than (\<) 3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* non-small cell lung cancer
* eligible to start treatment with erlotinib

Exclusion Criteria:

* hypersensitivity to metronidazole
Nicotine Virtual Reality Conditioned Place Preference

In this between-subjects, placebo controlled, double-blind study, the investigators will examine the effects of low oral doses of nicotine on the learning and extinction of a conditioned place preference acquired in a virtual reality environment by healthy human subjects. Physiological and subjective responses to the drug will also be monitored.

External cues and contexts contribute to the development of smoking and the use of other drugs, and drugs themselves can alter the value of conditioned cues. Interestingly, nicotine increases the acquisition of new learning, and has been considered as a "cognitive enhancer". Nicotine also prolongs responding when responding is no longer rewarded, during extinction. Although many studies have examined the effects of drugs on learning (acquisition) and unlearning (extinction) in laboratory animals, few have investigated drug effects on learning in humans. Recently, novel procedures have been developed to study conditioning in humans, pairing initially neutral places with food, money or drugs. The investigators will use one of these procedures, a virtual place conditioning procedure, to study how nicotine affects the acquisition and extinction of conditioned behaviors in humans.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have at least a high school education and be in good physical and mental health.

Exclusion Criteria:

* Individuals with current medical conditions, and/or a history of serious medical problems (e.g., cardiac, kidney, liver, and neurological).

Additional Exclusion Criteria include:

* regular medication,
* pregnancy,
* color blindness,
* left-handedness,
* consumption of 5 or more cigarettes per day,
* English non-fluency and current DSM-IV Axis 1 diagnosis excluding nicotine dependence.
Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes

This is a pilot study with a single active treatment arm. The study is designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of Type 2 Diabetes. In particular, the primary outcome measure is a reduction in A1c.


Eligibility Criteria:
Inclusion Criteria

A subject is eligible for the study if all of the following criteria are met:

* Provide written informed consent prior to enrollment.
* Is male or female between 18-70 years old.
* Has been diagnosed with type II diabetes for greater than 12 months.
* Is currently either using lifestyle modification or taking one or two of the following oral antihyperglycemic agents and has been on stable doses for 90 days prior to screening:

  * metformin
  * DPP-4 inhibitors (sitagliptin, saxagliptin, alogliptin, linaglyptin)
  * Pioglitazone
  * GLP-1 agonist (exenatide, liraglutide, exenatide LAR)
  * SGLT-2 Inhibitors (dapaglifozin, canagliflozin)
* Has an A l c between 7.5 - 9.0% based upon point of care testing performed at visit 1.
* Currently performs self-monitoring blood glucose checks at least 3 times per week.
* Able to adhere to protocol requirements.

Exclusion Criteria

A subject will be excluded if any of the following criteria are met:

* Has Type 1 Diabetes or Gestational Diabetes.
* Is pregnant or planning to become pregnant during the course of the study.
* Current use OR use in the past 6 months of sulfonylureas.
* Current use OR use in the past 6 months of insulin
* History of cardiovascular disease or cerebrovascular disease.
* Any planned surgery during the course of the study.
* Current continuous renal replacement therapy.
* Current oral or injectable steroid use or use within the previous 3 months.
* Previous or current treatment with deep brain stimulation.
* Any previous known disease, injury, or surgical intervention involving the brain or central nervous system.
* Moderate or greater hearing loss.
* Presence of a cochlear implant.
* Diagnosed vestibular dysfunction.
* Eye surgery within the previous three months.
* Any history of previous ear surgery.
* Active ear infections or a perforated tympanic membrane.
* Presence of a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only

A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh

The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).

The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted)
* Written informed consent
* ≥ 18 years of age
* Hiatal hernia documented by barium x-ray and/or gastroscopy and/or manometry by one or more of the following criteria:

  * \> 5cm hiatal hernia
  * 1/3 of the stomach in the thorax

Exclusion Criteria:

* Lack of patient consent for study participation
* Lack of consent to study due to linguistic or mental incomprehension
* Patients in poor general condition (lack of anesthesia ability)
* Pregnancy
* Prior surgery on the stomach or gastroesophageal junction
* Simultaneous surgery because of another illness
PD-L1 Expression in Advanced Osteosarcoma

The expression level of PD-L1 on tumor cells is a pivotal point which might have some influence on prognosis, especially for those who might use PD-1 or PD-L1 antibody for treatment. The aim of this study is to detect the expression of PD-1 on advaced osteosarcoma patient who might use these antibodies for treatment. All those specimen should be taken by pathologist and confirmed with high tumor cellularity.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis confirmed histologically and reviewed centrally;
* received surgery in Musculoskeletal Tumor Center of Peking University People's Hospital with appropriate sample for immunohistochemical staining;
* progressing upon prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
* having measurable lesion according to RECIST 1.1;
* Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months;
* intend to receive anti-PD-1/anti-PD-L1 antibody for therapy.

Exclusion Criteria:

* fail to be followed up regularly.
* sample disqualification.
Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)

Hamsa-1™ is an anti-angiogenic drug combination designed for the treatment of cancer. The investigational product Hamsa-1™ comprises of four well-known active components. The therapy is administrated at a unique dosing regimen that was found to be effective and advantageous in terms of safety.The product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. This Phase IIb clinical trial aims to evaluate the efficacy of Hamsa-1™ for the treatment of metastatic Castration Resistant Prostate Cancer (CRPC) patients.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects willing and able to give written informed consent
2. Confirmed metastatic castration resistant prostate cancer and rising PSA
3. ECOG performance status ≤ 1
4. Adequate renal function, hepatic function and bone marrow reserve.
5. Subjects capable of swallowing.

Exclusion Criteria:

1. Hypersensitivity to one or more of the Hamsa-1™ active components
2. Glucose-6-phosphate-dehydrogenase deficiency (G6PD)
3. Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
4. Subjects who received any investigational medication, antineoplastic therapy, or any significant change in treatment within 1 month prior to screening
5. Subjects with visceral metastases (e.g. liver, lung)
6. Subjects who received more than 2 prior chemotherapies for the treatment of prostate cancer
7. Subjects suffering from circumstances likely to interfere with absorption of orally administrated drugs
8. Subjects unwilling to or unable to comply with study protocol
Plasma Dilution and Infusion to Improve Cognition in Mild Cognitive Impairment (MCI)

In the ADDITION-MCI project, patients with a diagnosis of mild cognitive impairment probably caused by Alzheimer's disease will receive plasma exchange.

Repeated plasma exchanges will be conducted, and cognitive outcomes will be measured before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Alzheimer's Disease

MoCA score \< 27 and \>17

Able to give informed consent as judged by the doctor setting the AD diagnosis and study doctor.

At least one biomarker of the AT(N)-classification system supporting the diagnosis

Expected to live more than five years at inclusion by the study doctor.

Exclusion Criteria:

Known IgA deficiency

Known severe protein S depletion

Previous severe allergic reaction after transfusion of a blood product

Known heart failure

Known liver failure

Known kidney failure

Previous cancer \<10 years.

Not deemed able to participate by the study staff

Other severe chronic diseases, interfering with the TPE-procedure

Ongoing infections

Other unresolved medical conditions

Known coagulopathies

Fulfilling ICD-10 criteria for dementia at baseline, as evaluated by the evaluating physician.

Peripheral veins not expected to be suitable for repeated venous access procedures.
Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors

The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to assess the anti-tumor activity of MEK162 in combination with panitumumab.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Metastatic colorectal cancer
* Progression on or following standard therapy, or no standard therapy (phase Ib). Progression on or following at least 2-prior fluoropyrimidine-containing chemotherapy regimens (phase II)
* Written documentation of mutant or wild-type RAS
* Life expectancy ≥ 3 months
* ECOG performance status ≤ 2

Exclusion Criteria:

Phase II arms 1 and 4 only: previous treatment with cetuximab, panitumumab, and/or other EGFR inhibitors

* Previous treatment with MEK-inhibitors
* History of severe infusion reactions to monoclonal antibodies.
* Symptomatic or untreated leptomeningeal disease
* Symptomatic brain metastasis
* Current evidence of retinal disease; history of CSR, RVO or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO and history of keratitis.
* Acute or chronic pancreatitis
* Clinically significant cardiac disease
* Not adequate hematologic, renal and hepatic function
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with critical limb ischemia confirmed by toe pressure, ABI, TCOM
* Levels of arterial occlusion are femoropopliteal or tibioperoneal occlusion
* Poor distal artery runoff
* Age 18-70 year

Exclusion Criteria:

* Planned for major amputation within 4 weeks
* Receive blood component within 4 weeks
* Acute myocardial infarction
* severe valvular heart disease
* renal failure
* liver failure
* Cancer
* Hypercoagulable state
* Severe infection
* Pregnancy
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects

The purpose of this study is to describe the single dose pharmacokinetics of total radioactivity in plasma and whole blood following PO administration of \[14C\] TR-701 in healthy adult male subjects.

This study will be an open-label, single-dose study of the absorption, metabolism, and excretion of 200 mg \[14C\]-TR-701 (approximately 100 μCi) administered orally following at least an 8-hour fast. Subjects will receive a single dose of 200 mg \[14C\] TR 701 (approximately 100 μCi) administered as an oral solution.

The dose will be administered following at least an 8-hour fast and followed by a 4-hour fast from food, not including water.

Eligibility Criteria:
Inclusion Criteria:

1. Males, between 18 and 50 years of age, inclusive.
2. Body mass index (BMI) of 20 kg/m2 to 29.9 kg/m2, inclusive.
3. In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs.

Exclusion Criteria:

1. Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator and Sponsor).
2. History of an abnormal ECG that is clinically significant in the opinion of the Investigator.
3. History of hypersensitivity, intolerance, or allergy to antibiotics of the oxazolidinone class, to any ingredient of the formulation.
Biofeedback for Psoriasis

We are conducting a proof-of-concept trial to study the impact of HRV-biofeedback, a mind-body technique designed to improve stress resilience, on the quality of life, mood, and clinical skin severity of patients with psoriasis.

Psoriasis is a common, chronic stress-related disease of the skin and joints that is associated with significantly impaired quality of life (QoL) and psychological comorbidity, most notably anxiety, depression, and suicidality. The objective of this study is to explore the influence of heart rate variability-biofeedback training (HRV-BF) on measures rating QoL, mental health, and clinical severity of psoriasis. We aim to further understand the bidirectional relationship between stress and the skin and to determine whether HRV-BF has the potential to be a beneficial adjuvant therapy for psychocutaneous disorders. A single-arm, proof-of-concept trial will be conducted using a modified, 7-week HRV-BF resiliency protocol at Bastyr University California in a small sample of subjects with moderate to severe plaque psoriasis. In order to measure the outcomes of the intervention on the clinical manifestations of psoriasis, we will be administering a set of validated, physician-rated and patient-reported questionnaires, including the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Patient Health Questionnaire (PHQ-9), and Generalized Anxiety Disorder (GAD-7), in addition to other HRV-BF-specific screening questionnaires to assess whether the subject has any contraindications to this protocol. These assessments will be collected at baseline, end of trial, and at 1-month follow-up for statistical analysis. The goal of this trial is to explore the novel application of HRV-BF for psychocutaneous disorders in order to fill a gap in the provision of evidence-based, integrative services addressing the serious and sometimes fatal psychological impacts of psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Diagnosed with or are currently experiencing symptoms of psoriasis
* Located in San Diego or within driving distance
* Have daily access to a smart phone, computer, or tablet
* Able to read and understand English

Exclusion Criteria:

* High risk of suicidality
* History of chronic kidney disease
* Pacemaker
* Active pregnancy or treatment of cancer or HIV