cyrilzakka/clinical-trials huggingface dataset:
Adolescent SCreening To Help Eliminate Misuse

The specific aim of this study is to evaluate the performance of three substance use screening instruments (S2BI, BSTAD, and TAPS Tool) against a criterion standard of Diagnostic Statistical Manual - 5 (DSM-5) substance use disorder (SUD) diagnoses in an adolescent population.

This study seeks to evaluate the psychometric properties of three substance use screening and brief assessment tools for adolescents against criterion standard of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) substance use disorder diagnoses in a population of adolescents who receives care at a participating primary care practice; or, for an initial evaluation at a substance use disorders program for youth. The three tools to be tested are the Brief Screener for Tobacco, Alcohol and Drugs (BSTAD); Screening to Brief Intervention (S2BI) screening tool; and the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool. BSTAD and S2BI were developed specifically for use with adolescents and each has been validated in a single trial. These tools use past-year "frequency of use" questions to determine risk level for a substance use disorder. The TAPS tool includes both screening and brief assessments and while it has been studied more extensively in adult primary care patients, its validity with adolescents is not known. For youth, alcohol, marijuana and tobacco use, and particularly early initiation, are associated with greater risk of substance use disorders, use of illicit drugs, misuse of opioids, and opioid use disorders. Thus, identifying and addressing substance use early is an important form of prevention that can be delivered in medical care settings for this age group.

Eligibility Criteria:
Inclusion Criteria:

1. Be between the ages of 12-17 years, inclusive, at the time of screening.
2. A patient registered at one of the primary care sites; or, presenting for an initial substance use disorders evaluation at the youth substance use disorders program site.
3. Be willing and able to participate in the study.

Exclusion Criteria:

1. Previously enrolled in the current study, as determined by the Chart Review Log/Clinical Staff Referral Log and through self-report of potentially eligible participants.
2. Inability to comprehend spoken or written English.
3. Inability to self-administer any type of computer tool due to physical limitations.
4. Physical or emotional illness that interferes with participation on the day of the appointment, as determined by either the clinical team or research team.
5. Per participant self-report, treated in a residential/inpatient substance use disorders treatment program within the past 12 months.
6. For patients at primary care sites, current, self-reported enrollment in a substance use disorders treatment program at time of recruitment.
7. Per participant self-report, participant is currently in the custody of the Department of Youth Services, the Department of Children and Families, or living with a foster family.
8. Per participant self-report, currently pregnant or parenting.
A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.


Eligibility Criteria:
Inclusion Criteria:

1. Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
2. Age 18 years or above.
3. Males, or females of non-child bearing potential.
4. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).

Exclusion Criteria:

1. Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application.
2. Female subjects who are pregnant, of child-bearing potential or who are breast feeding.
3. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months(adalimumab, alefacept, infliximab), 4 months(ustekinumab) or 4 weeks/5 half-lives (which-ever islonger) for experimental biological products prior to randomisation and during the study.
4. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study.
5. Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:

   - Potent or very potent (WHO group III-IV) corticosteroids.
6. Subjects using of phototherapy within the following time periods prior to randomisation and during the study:

   * PUVA (4 weeks)
   * UVB (2 weeks)
7. Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:

   * WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
   * Topical retinoids
   * Vitamin D analogues
   * Topical immunomodulators (e.g. macrolides)
   * Anthracen derivatives
   * Tar,
   * Salicylic acid.
8. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
9. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview
10. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
11. Subjects with current participation in any other interventional clinical, based on interview of the subject
Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis

Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR.

Lung cancer patients with newly diagnosed CNS metastasis with- at least one brain lesion measuring \> 1 cm in longest dimension - not eligible for surgery or stereotactic radio-surgeryOpen-label, multicentre, national, randomised (1:1) phase II trialArm A: WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance Arm B: Gefitinib

Eligibility Criteria:
Inclusion Criteria:

* Patients must have signed a written informed consent form prior to any study specific screening procedures
* 18 years or older
* KPS ≥ 50%
* Histologically confirmed adenocarcinoma of the lung
* Activating mutation of EGFR
* Newly diagnosed CNS metastasis or in progression with at least one measurable lesion in the brain (defined as any lesion \> 1 cm on T1-weighted contrast enhanced MRI)
* Patients could enter the study regardless of previous treatment (included chemotherapy) for metastatic extracranial disease, except TKI.
* No steroids or stable or decreasing dose of steroids for at least 5 days before the MRI evaluation.
* Adequate hematologic, liver and renal functions: neutrophil count ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; Hb ≥ 9 g/Dl; Total bilirubin \< 1.5 x ULN; AST or ALT \< 2.5 x ULN (\< 5 x ULN in patients with liver metastases); Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min

Exclusion Criteria:

* Prior treatment of brain metastases with WBRT or TKI
* Patient eligible for radiosurgery or surgical resection
* Contre indication at the radiotherapy
* Leptomeningeal disease
* Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) within the the 5 years before study entry
* Prior treatment with Gefitinib or other TKI
* Pregnant or breast feeding women
* Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception
Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome

PiCCO has been widely used in critical care settings for several decades. Together with pulmonary artery catheter, it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. However, its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.

PiCCO comprises techniques of pulse contour analysis and transpulmonary thermodilution, and can provide important information on hemodynamics and pulmonary functions. It has been widely used in critical care settings for several decades. Together with pulmonary artery catheter (PAC), it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. During last two decades, many well designed clinical trials have been conducted to see whether the use of PAC would benefit patient outcome. The result consistently showed that PAC added no benefit in terms of mortality, ICU length of stay, organ failure free survival days, and the length of mechanical ventilation. Since PiCCO is relatively new to PAC, and its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.

Eligibility Criteria:
Inclusion Criteria:

Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both.

Shock was defined by the presence 4 criteria:

* Heart rate of at least 90/min;
* A respiratory rate of at least 20/min or a PaCO2 of 32mmHg or lower or the use of mechanical ventilation;
* The use of vasopressors to maintain a systolic blood pressure of at least 90mmHg despite fluid resuscitation, low dose of dopamine (≤ 5 μg/kg per minute), or dobutamine;
* at least 1 of 3 signs of hypoperfusion (urine output \< 0.5mL/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a Glasgow coma scale score of ≤ 6; plasma lactate higher than the upper limit of the normal value).

Acute respiratory distress syndrome：

* the presence of acute decrease in PaO2/FIO2 to 200mmHg or lower,
* bilateral pulmonary infiltrates or a chest radiograph consistent with edema;
* no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation.

Exclusion Criteria:

* Patients were moribund.
* signed do-not-resuscitation odor.
Immediate Analgesic Effects of Cheek Acupuncture for Acute Gouty Arthritis

The goal of this clinical trial is to evaluate the immediate analgesic effect and patients' evaluation of the treatment of cheek acupuncture in patients with acute gouty arthritis. The main question it aims to answer are: Does cheek acupuncture has immediate pain relief effects on patients with acute gouty arthritis. Participants will received cheek acupuncture for 30 mins.

If there is a comparison group: Researchers will compare etoricoxib group to see if cheek acupuncture is superior to etoricoxib for improvement of acute pain in subjects with acute gouty arthritis.

The symptoms of acute gouty arthritis (AGA) are extremely painful, but most patients do not begin to experience pain relief until after they have been seen by a doctor and have taken their medication, leaving a time lag between the time they are seen and the time the treatment is effective. In clinical practice, researchers have found that the use of cheek acupuncture at the first visit to the patient often provides some immediate pain relief, but there is no evidence-based evidence for this.

This project was designed as a prospective, randomized, controlled clinical trial, in which patients with AGA who were seen for the first time were studied, and the treatment group was given cheek acupuncture and the control group was given oral etoricoxib tablets. VAS will be recorded before treatment, 0 min, 30 min, 1 h and 2 h after the start of treatment to depict the immediate analgesic efficacy curve and compare the immediate analgesic effect of the two groups at different time points. If the project is successfully completed, it will explore a treatment method for acute gouty arthritis that is fast-acting, painless and effective, eliminating the time lag between consultation and efficacy for the benefit of gout patients.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for acute gouty arthritis and with attacks in the unilateral ankle or first metatarsophalangeal joint;

  * Age ≥18 years old and ≤75 years old, regardless of gender; ③ The gouty arthritis attack is within 48h; ④ Without therapy with targeted topical treatment or self-administered medications including colchicine, anti-inflammatory pain medications, hormones, herbs, etc.

Agreement to comply with the clinician's treatment plan.

Exclusion Criteria:

* Pregnant or breast-feeding

  * Patients with malignant tumors, severe dysfunction of the heart, liver, and kidneys, diabetes mellitus and hypertension

    * Mental disorders that render the patient unable to understand the nature of the study, its scope, and possible outcomes or unable to follow the doctor's advice

      * Allergic to the components of the drug in this study

        * Patients with active peptic ulcers/bleeding, or previous recurrent ulcers/bleeding.

          * History of asthma, urticaria or allergic reactions induced by taking aspirin or other non-steroidal anti-inflammatory drugs

            * Congestive heart failure (New York Heart Association \[NYHA\] cardiac function class II-IV)
Impact of Pyloric Injection of Magnesium Sulfate and Lidocaine Mixture on Outcome After Sleeve Gastrectomy

Postoperative nausea and vomiting is a common adverse effect after sleeve gastrectomy, mostly due to increased intragastric pressure. The present trial aimed to assess the effect of pyloric injection of mixture of magnesium sulfate and lidocaine on postoperative gastric intraluminal pressure and incidence of nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Patients that aged between18 and 65 years.
* American Society of Anesthesiologists (ASA) class I - III.
* Morbidly-obese patients who failed to achieve and maintain a clinically significant weight loss through supervised non-surgical methods for at least 6 months.
* Surgery was conducted as the first line of treatment in case of patients with BMI ≥ 50 kg/m2 (super obese).

Exclusion Criteria:

* Obesity secondary to endocrine disorders.
* History of any previous bariatric procedure.
* Impaired intellectual capacity or major psyciatric disorder.
* Sweet eaters who would not adopt a change of postoperative eating habits.
* Lack of willingness and motivation to embrace postoperative lifestyle changes.
* Substance abuse.
* Pregnancy or expected pregnancy in the following 12 to 18 months.
* Severe gastroesophageal reflux disease
Evaluation of Pediatric Measles Cases in 2019: Single-Center Experience

Measles, can be prevented and eliminated by vaccination, is a highly contagious viral disease that can lead to serious complications, disability, and death. As a result of the World Health Organization (WHO) and United Nations International Children's Emergency Fund (UNICEF) strategic plans, the annual global incidence of measles decreased by 75% over the period 2000-2015, and the estimated global mortality rate fell by 73%. For the current 2019 period, the European and the Eastern Mediterranean Region has recorded respectively more than two-fold and 1.5-fold increase in reported measles cases. As it is known, no specific antiviral treatment exists for the measles virus therefore, vaccination is still the most effective method of preventing disease.

The aim of this study was to evaluate the measles cases in districts where the refugees live quite intensely.

Measles, can be prevented and eliminated by vaccination, is a highly contagious viral disease that can lead to serious complications, disability, and death. As a result of the World Health Organization (WHO) and United Nations International Children's Emergency Fund (UNICEF) strategic plans, the annual global incidence of measles decreased by 75% over the period 2000-2015, and the estimated global mortality rate fell by 73%. For the current 2019 period, the European and the Eastern Mediterranean Region has recorded respectively more than two-fold and 1.5-fold increase in reported measles cases. As it is known, no specific antiviral treatment exists for the measles virus therefore, vaccination is still the most effective method of preventing disease.

The aim of this study was to evaluate the measles cases in districts where the refugees live quite intensely.

This retrospective study was consecutively enrolled children who were considered as suspicious measles case according to with clinical features and attended in Esenler Gynecology and Pediatrics Hospital Pediatric Clinic between 01 January-30 June 2019.

Eligibility Criteria:
Inclusion Criteria:

* The suspicious case of measles
* Measles/Rubella Case Notification and Laboratory request and result form and Measles/ Rubella Case Study form must be filled
* Accept the informed consent form
* Positive Measles Ig M and Measles Ig G laboratory test

Exclusion Criteria:

* Rejected the informed consent form
Protocol-driven Hemodynamic Support for Patients With Septic Shock

This research is being done to see if a protocol (a set of orders that determine how much and how quickly a drug/fluid is given) for fluid and drugs used to increase blood pressure (vasopressors) will work better then general clinical practices to improve outcomes in patients with septic shock.

Septic shock is low blood pressure caused by an infection. Sepsis is the most common cause of death in non-cardiac intensive care units, and septic shock is the most severe form of sepsis. Treatment for septic shock includes giving antibiotics, intravenous fluids, and medications to raise the blood pressure (vasopressors).

We would like to see if a protocol-driven management strategy for septic shock can shorten time on vasopressors and limit the number of side effects. We have constructed a protocol that will allow the nurse at the bedside, in conjunction with the physician's orders, to adjust the amount of fluids and medications that raise the blood pressure (vasopressors).

Eligibility Criteria:
Inclusion Criteria:

* ACCP/SCCM sepsis criteria
* Need for institution of vasopressors after adequate volume resuscitation

Exclusion Criteria:

* Age\< 18
* On vasopressors for \> 24 hours prior to ICU admission
* Other cause for shock ( cardiac tamponade, massive pulmonary embolus, cardiogenic shock)
* Physicians and family not committed to aggressive medical therapy ( a patient will not be excluded if he/she would receive all care except for attempts at resuscitation from cardiac arrest)
Pandemic Influenza Plasmid DNA Vaccines (Needle)

The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system response will be studied throughout the trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years of age
* Able to provide informed consent and be followed for 6 months

Exclusion Criteria:

* No immunomodulatory therapy within the past 6 months
* No evidence of immunodeficiency or pregnancy
* No laboratory or evidence of clinically significant medical disease
* No history of previous pDNA immunization
* No influenza immunization within the past 30 days
* No blood donations within 30 days of screening visit
* No history of bleeding disorder
* No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines
Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Phase III study to compare the safety and efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR 063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open-angle glaucoma or ocular hypertension.
* C/D ratio ≤ 0.8
* Zero to three preoperative ocular hypotensive medications

Exclusion Criteria:

* Active corneal inflammation or edema.
* Retinal disorders not associated with glaucoma.
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting

This is a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.

Once the patient provides informed consent, he or she is enrolled in the study. Patients will be followed from enrollment until 1) 30 days after alpelisib treatment discontinuation, or 2) death, or 3) lost to follow-up, or 4) patient withdrawal, or 5) physician decision to end treatment/study, or 6) end of the study, whichever occurs first. The end of the study is defined as a maximum of 12 months after the date the last patient was enrolled (LPFV); if the last patient is still on treatment on that date, they will not be followed up any further

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from the patient or a legally acceptable representative, obtained before any study-related activities are undertaken
* Patients diagnosed with HR+, HER2- locally advanced or metastatic breast cancer with a PIK3CA mutation
* Patients who have disease progression following endocrine therapy as monotherapy
* Patients must be postmenopausal women, or men, ≥18 years of age
* Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant

Exclusion Criteria:

* Use of alpelisib prior to signing the informed consent form for this study
* Participation in an interventional study within 30 days prior to the initiation of alpelisib