cyrilzakka/clinical-trials huggingface dataset:
The Teen Marijuana Check-Up

This behavioral research is an efficacy trial evaluating an intervention called "The Teen Marijuana Check-Up" with non-treatment seeking adolescent marijuana users.

Three hundred adolescents who smoke marijuana (ages 14-19), recruited in four Seattle-area high schools, will be enrolled in the trial. Participants will be recruited either through in-class presentations focusing on marijuana or via referrals from school staff. They will first be assessed regarding use of marijuana, alcohol, and other drugs, as well as pertinent attitudes and goals. Participants will then be randomly assigned to one of three conditions.

* The experimental intervention is a two-session motivational enhancement treatment. A personalized feedback report, containing information from the participant's assessment as well as normative comparison data, is reviewed, with the Health Educator employing motivational interviewing strategies intended to enhance motivation for reduction or cessation of marijuana use. Specific goals for change and behavior change strategies are discussed with participants who wish support to change their marijuana use.
* The comparison condition involves two educational sessions focusing on the health and behavioral effects of marijuana.
* The third condition (delayed treatment control) involves a minimal baseline assessment followed three months later by a reassessment interview. Those assigned to this condition will then be given their choice of either active treatment.

Following completion of their two intervention sessions, participants in the two active treatments will be offered an additional four sessions of cognitive-behavioral skills training in which the focus is strategies in quitting marijuana. All participants will be reassessed at 3 and 12 months following their initial assessment interviews.

Eligibility Criteria:
Inclusion Criteria: Individuals who contact the project will be screened according to the following inclusion criteria:

* age (14-19 years old),
* grade level (freshmen through seniors) and
* marijuana use (smoked 9 or more days in past 30).

Exclusion Criteria: Individuals will be excluded if:

* they are not fluent in English,
* they have a thought disorder that precludes full participation,
* they refuse to accept randomization to condition.

In addition to the inclusion and exclusion criteria, participants who appear to be in psychological or physical distress will be assessed further and referred to other services as appropriate. The need for other services will not necessarily preempt participation in the TMCU unless the individual is incapable or unwilling to complete the protocol. As was the case in our Stage 1b trial, all ineligible applicants will be offered a single feedback session, and the Strategies That Work booklet will be offered to those who indicate any interest in reducing or quitting marijuana use.
Efficacy of Pancrelipase on Postprandial Belching and Bloating.

The hypothesis of this study is that the administration of pancrelipase with meals will benefit symptoms of post-prandial bloating, pain and eructation.

Subjects will complete a double-blind crossover study in which, for one week periods, they will receive two pancrelipase tablets with each of the three major meals or a similarly administered identical placebo. Three times daily, subjects will rate the severity of belching, epigastric discomfort, epigastric fullness, bloating, and nausea.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will have either bothersome upper abdominal discomfort, bloating (feeling of abdominal distention) or belching following meals for at least 12 month's duration. Subjects must have had a normal upper gastrointestinal endoscopy and/or upper GI series during the preceding three years.

Exclusion Criteria:

* Individuals with a history suggestive of organic disease such as recent weight loss, nausea, vomiting, GERD, recent changes in bowel habits will be excluded from the study.
Dead Space Monitoring With Volumetric Capnography in ARDS Patients

This studies´ objective is to describe how different PEEP levels affect dead space measured by Bohr´s formula.

In ARDS patients PEEP has contradictory effects on ∆P (driving pressure of the airway) hat depends on the balance between lung recruitment and overdistension. Some authors showed that incremental levels of PEEP did not much affect dead space in ARDS patients. These studies used different methods for the assessment of dead space.

Such technique also overestimates the dead space. We believe that the right way to measure dead space is applying the original Bohr's equation using the mean PACO2 value. Therefore, the aim of this observational study was to describe the effect that PEEP has on Bohr's dead space and its sub-components in mechanically ventilated patients with ARDS.

This observational study was performed in the Intensive Care Unit of a University Hospital.

Protocol design The protocol started recording the data during baseline protective ventilation. After 15 minutes of data recording, we studied four levels of PEEP - 0, 6, 10 and 16 cmH2O - which were randomly assigned by a randomization table.

Respiratory, hemodynamic, arterial blood gas analysis and volumetric capnographic parameters were recorded. We analyzed the last 2 minutes of each protocol steps consisting in more than 30 breaths or data-points.

Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years
* requirement of invasive mechanical ventilation for more than 4 hours and less than 12 hours
* severe hypoxemia (PAFI \< 200) secondary to ARDS or post-operatory atelectasis

Exclusion Criteria:

-requirement of invasive mechanical ventilation prior to enrollment in this study
InSeal Vascular Closure Device Clinical Study Protocol

The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.

The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the study population.


Eligibility Criteria:
Inclusion Criteria:

* Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath.
* Subject age is at least 18 years
* Patient has signed most recent approved version of the Informed Consent
* Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution.

Exclusion Criteria:

* Women Of Child Bearing Potential (WOCBP)
* Legally non-competent patients
* Patient participating in another clinical study at the time of the InSeal VCD study
* Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization
* Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure
* Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment
* Prior vascular surgery or vascular graft in region of access site
* Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device
Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)

The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The investigators hope to determine if one is more effective at preventing rejection or if both are equally effective.

Graft rejection is one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used after transplant surgery. The steroid eye drop dosing regimen varies from surgeon to surgeon, because no studies have been done to determine the optimum dosing regimen.

Eligibility Criteria:
INCLUSION CRITERIA: The following are requirements for inclusion in the study:

* Male or female patient, at least 18 years of age, who is a candidate for DMEK due to corneal endothelial dysfunction or who has undergone DMEK within the last 7 weeks
* Patient is able and willing to administer eye drops.
* Patient is able to comprehend and has signed the Informed Consent form.
* Patient is likely to complete the entire one-year course of the study.
* Patient has best corrected visual acuity (BCVA) of at least 20/200 in the fellow eye.
* Corneal neovascularization will not be judged as an exclusion criteria for the study

EXCLUSION CRITERIA: The following are exclusion criteria for patients in this study:

* A patient with a previous failed graft in the study eye with a history of a prior rejection episode
* A patient exhibiting any intraocular inflammation
* A patient with a known sensitivity to any of the ingredients in the study medications
* A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
* A patient with abnormal eyelid function
* A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis
* A patient with the presence of any ocular disease that would interfere with the evaluation of the study treatment
* A patient with a history of non-compliance with using prescribed medication
* A patient who is concurrently involved in or participated in another clinical trial within 30 days prior to enrollment in this study.
Multicentre Registry of Treatments and Outcomes in Patients With Chronic Lymphocytic Leukaemia (CLL) Or Indolent Non Hodgkin's Lymphoma (iNHL)

The purpose of this study is to document the pharmacological treatment strategies used in treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle East and North African (MENA) region. This study will also record encountered tumor subtype and stage and the instituted pharmacological treatments, as well as assess the clinical outcomes of treatments.

Patients will be followed up to 30 months.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* CLL patients or
* iNHL patients
* Clinical decision made to initiate or adapt treatment of CLL/iNHL("Need to treat")

Exclusion Criteria:

* Patient deemed unfit for enrollment by the documented opinion of the investigator
* Watch and wait patients
* Richter's transformation
* Patients otherwise not eligible for (pharmacological) intervention
* Moribund patients
Web-based, Interactive Professional Education for Chronic Obstructive Pulmonary Disease

This study involves the development and evaluation of a web-based, interactive education program on chronic obstructive pulmonary disease (COPD) for primary care clinicians.

The research questions that this proposal addresses include:

1. Can an interactive, web-based COPD course be developed to disseminate evidence-based, best practice recommendations to primary care clinicians?
2. Can assessment tools be developed to evaluate the impact of the program on clinician behavior in clinical practice and on patient care?


Eligibility Criteria:
Inclusion Criteria:

* Primary care clinicians in training
* willing to participate

Exclusion Criteria:

* Specialists
Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse

Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well.

Response to this treatment is the most important prognostic factor and this patients has a benign disease course.

60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated steroids courses can lead to serious adverse events in children such as low bone density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side effect corelation between steroid dose and treatment duration.

guidelines for steroid dose for NS relapse are not based on retrospective clinical research but only on Nephrologists and experts opinion.

Rational- What would be the optimal low dose steroids and the shortest time of treatment in Nephrotic syndrome relapse?

Idiopathic nephrotic syndrome in children is the most common chronic glomerular disease. The first line of therapy is prednisone and about 90% of the patients will

response to this treatment. The course of the disease is characterized of

recurrent relapses and repeated prednisone therapy. While prednisone doses and

therapy duration in the disease diagnosis has been based on multiple prospective

studies, the dose and therapy duration in the relapses was never challenged in a

prospective control study.

To address this question we designed prospective 3 arm study to evaluate the

effective of exception steroid regiment to treat relapses versus lower doses.

The study population is children in the age 2-18 year old with steroid sensitive nephrotic syndrome.

After relapse will be diagnosed based on physical exam and urine tests, the

patients will randomize to receive prednisone doses that are 60/m2 or 45/ m2 or 30/ m2.

A measurement of time to obtain remission, duration of remission est. will be collected.

We plan to recruit 100 children in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Idiopathic nephrotic syndrome with a flair that needs steroids treatment.

Exclusion Criteria:

* Steroid resistance or treatment with Cyclosporin or Cellcept
The Efficacy of Severe Whitening and Delayed Fading in Acetic Acid-enhanced Endoscopy for Diagnosing Gastric Intestinal Metaplasia

Investigators found that the degree and the duration of aceto-whitening differed between gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed a severe degree of aceto whiteness and the whitening continued longer than the surrounding normal mucosa, which investigators called "severe whitening" and "delayed fading", and investigators realized that GIM could possibly be diagnosed by using these differences.The aim of this prospective study was to investigate the efficacy of "severe whitening" and "delayed fading" for diagnosing GIM.


Eligibility Criteria:
Inclusion Criteria:

* long-lasting upper gastrointestinal symptoms (\>15 years)
* atrophic gastritis or GIM identified at surveillance endoscopy

Exclusion Criteria:

* presence of advanced adenocarcinoma in the stomach
* presence of acute gastrointestinal bleeding
* presence of coagulopathy, uncontrolled impaired renal or liver disease
* presence of pregnancy or lactation
* presence of allergy to acetic acid
* age younger than 18 years or older than 80 years
* inability to provide written informed consent.
Estimation of the Tissue and Serum Levels of Interleukin (IL) -35 in Mycosis Fungoides: a Case Control Study

Tissue and serum samples from 20 MF patients and 20 normal healthy controls will be subjected for biochemical assessments by ELISA (Enzyme- linked immune-sorbent assay) for assessing the level of IL35.

Tissue and serum samples from 20 MF patients and 20 normal healthy controls will be subjected for biochemical assessments by ELISA (Enzyme- linked immune-sorbent assay) for assessing the level of IL35

Eligibility Criteria:
Inclusion Criteria:

* Patients with mycosis fungoides. Both genders. Age group ≥ 18 years old.

Exclusion Criteria:

* Patients with any other skin diseases. Patients who received treatments for mycosis fungoides in the past three months.

Subjects with history of solid or hematological malignancy as leukemia
Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies

The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.


Eligibility Criteria:
Eligibility Criteria Arm A:

* Age 60 years or older.
* New diagnosis of Acute Leukemia or MDS, or suspected diagnosis.
* Able to consent to the study.

Eligibility Criteria Arm B:

* Age 60 years or older with a hematologic malignancy.
* Plan to undergo an allogeneic blood or marrow transplantation or CAR T-cell therapy.
* Able to consent to the study.
SWOG-9023, DNA Analysis of Tumor Tissue From Patients With Metastatic Kidney Cancer

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.

PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with metastatic kidney cancer.

OBJECTIVES:

* Determine if cytogenetic abnormalities can predict clinical outcome, in terms of response to treatment and survival, in patients with metastatic renal cell carcinoma registered to the nephrectomy arm (arm I) of SWOG-8949.
* Correlate cytogenetic abnormalities and DNA content analysis (DNA index and S-phase fraction) with clinical outcome.

OUTLINE: This is a partially prospective, partially retrospective, multicenter, companion study.

Paraffin-embedded tumor tissue specimens from patients enrolled in SWOG-8949 are evaluated by cytogenetic analysis (e.g., presence of trisomy and loss of Y chromosome) and flow cytometric analysis (e.g., presence of nondiploid cells and presence of abnormal proliferation index).

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of renal cell carcinoma

  * Any T, any N, M1 disease as specified in SWOG-8949
* Eligible for and registered on the nephrectomy arm\* (arm I) of SWOG-8949 NOTE: \*Patients must be registered on this study before undergoing nephrectomy on SWOG-8949

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study)

Despite anti-thymocyte globulin has a mainstay role in preventing GvHD (and non-relapse mortality) in CB transplantation, it also induces delayed immune recovery, increased risk of cytomegalovirus and Epstein-Barr virus reactivation, post-transplant lymphoproliferative diseases, overall accounting for increased transplant-related mortality and/or increased relapse incidence. All these findings support the use of alternative approaches for in vivo T cell depletion in the setting of CB transplantation.

Study objectives. The primary objective is to evaluate neutrophil and platelet engraftment and day +100 CD4+ cell count in patients receiving matched CB unit transplant with a myeloablative conditioning regimen and a GVHD prophylaxis including post-transplant cyclophosphamide. Secondary objective is to estimate the incidence and severity of acute and chronic GVHD. Study endpoints. Primary endpoints are hematopoietic engraftment and day +100 CD4+ cell count. Secondary endpoints are acute and chronic GVHD

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 ≤ 75 years old
* CB unit transplantation (TNC\> 2,0 x10\^7/kg and \> 4/6 loci HLA matched)
* Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine
* GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF
* Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant.

Exclusion Criteria:

* Positive serologic markers for human immunodeficiency virus (HIV)
* Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection
Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.

This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 285 patients worldwide will take part in this study.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 yrs, male or female subject
* Subjects must have signs and symptoms of PsA ≤5 years duration at the time of the Screening Visit
* SJC AND TJC must be \>1 and ≤ 4
* For all regions, the local Regulatory Label for treatment with apremilast must be followed.
* Stable doses of protocol-allowed PsA medications
* General good health (except for psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).
* Comply with protocol-required contraception measures
* Subject meets the Classification Criteria for Psoriatic Arthritis \[CASPAR\] Criteria for PsA at the Screening visit

Exclusion Criteria:

* Prior use of \>2 csDMARD to treat PsA
* Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
* Use of intra-articular (IA) or intra-muscular (IM) glucocorticoid injection within 8 weeks before the Baseline Visit.
* Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study.
* Prior use of cyclosporine.
* Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
* Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin levels in IBD patients in clinical remission. During the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.


Eligibility Criteria:
Inclusion Criteria:

* Age ranged between18 and 80 years.
* Patients with Ulcerative Colitis (diagnosed on the base of clinic, endoscopic and histologic criteria) in clinical remission (SCCAI = 0) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
* Patients affected by Crohn's Disease (diagnosed on the base of clinic, endoscopic and histologic criteria) ) in clinical remission (CDAI \< 150) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
* Fecal calprotectin at baseline \> 150 μg/g.

Exclusion Criteria:

* Patients affected by Ulcerative Colitis and Crohn's Disease respectively with a SCCAI ≥ 1 and a CDAI ≥150.
* Patients on steroid therapy.
* Patients in therapy wih warfarin or other anticoagulants.
* Known or supposed ipersensitivity to eicosapentaenoic acid/omega 3.
* Women in fertile age which refuse to use contracceptives specified in the study (oral contraception, IUD) and breastfeed women.
* Patients with severe clinical conditions which the investigator consider to controindicate patient partecipation at the study.
* Therapy modifications and/or assumption of sperimental therapies within three months before the study inclusion.
* Patients unable to follow protocol procedures and to sign the informate consent.