cyrilzakka/clinical-trials huggingface dataset:
Development and Testing of Adolescent Twelve-Step Facilitation

This study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people. In the first phase of the study, the investigators are developing and revising a preliminary manual for the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the preliminary integrated TSF protocol. In the second phase of the study, the investigators will compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized experimental design for adolescent substance use disorder with 60 adolescents. As a result, the investigators will examine potential mechanisms that may underlie the efficacy of iTSF in improving alcohol and other drug use outcomes. The investigators will test group differences on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics Anonymous attendance and involvement) and whether these variables are associated with substance use outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Young people between the ages of 14 and 21 that meet criteria for alcohol or other drug abuse or dependence.

Exclusion Criteria: Youth

* with an active psychotic disorders
* who are in another substance use disorder (SUD) treatment program or receiving SUD related psychotherapy that could conflict with our treatment
* with a history of severe or complicated withdrawal (e.g., alcohol seizure history)
* who may be using alcohol/drugs prior to study entry at levels likely to result in severe withdrawal complications, in the absence of any history
* taking addiction treatment medications (e.g., Buprenorphine)
* who cannot speak English because the treatment and assessment instruments will be conducted in English
Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection （SHARE2301）

Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of stomach cancer. Progressive application of dual therapy for the eradication of Helicobacter pylori. Tegoprazan, a Potassium-Competitive Acid Blockers. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified.

In 1989, it was suggested that amoxicillin combined with PPI could eradicate Hp infection, and in 2015, a prospective, multicenter, randomized controlled study in Taiwan with a large sample showed that the eradication rate of Hp could reach 96.6% with dual therapy for primary treatment of Hp infection, and the results of intention-to-treat analysis were as high as 95.3%. 95.3%. In 2020, a meta-analysis showed that high-dose dual therapy had the same efficacy and fewer side effects than other recommended regimens in first-line treatment. In terms of dosing days, multiple randomized controlled studies and meta-analyses from 2020-2021 have shown that 14 days of high-dose dual therapy is more effective in eradicating H. pylori.

Tegoprazan, a Potassium-Competitive Acid Blockers (P-CAB), is a new type of acid-suppressing drug that compensates for the short half-life of acid-activated traditional acid-suppressing PPI and the low mucosal healing rate due to insufficient acid suppression. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified. 2022, tegoprazan was approved by the State Drug Administration for the new indication of eradication of H. pylori infection in adults in combination with appropriate antimicrobial therapy, and its efficacy in clinical application has not yet been verified.

Eligibility Criteria:
Inclusion Criteria:

* Helicobacter pylori infection (either positive for histopathological test, rapid urease test, or C13/C14 urea breath test).
* Patients who have not previously received helicobacter pylori eradication therapy.

Exclusion Criteria:

* Serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
* Those who are not willing to take contraceptive measures during pregnancy, lactation or the trial.
* Active gastrointestinal bleeding.
* History of drug allergy.
* History of upper gastrointestinal surgery.
* Medication history of bismuth, antibiotics and PPI within 4 weeks.
* Other behaviors that may increase the risk, such as alcohol and drug abuse.
* Unable or unwilling to provide informed consent.
Cardiomyopathy in Steroid-resistant Nephrotic Syndrome: Impact of Focal Segmental Glomerulosclerosis

The objective of this study is as follows:

* Perform genetic analysis to define the prevalence of each of the known gene mutations in an unselected cohort of patients with focal segmental glomerulosclerosis (FSGS)
* Perform a comprehensive assessment of cardiovascular status to determine the incidence of any cardiac abnormalities in patients with FSGS
* Determine if patients with mutations in specific proteins are more likely to have cardiovascular abnormalities
* Initiate long-term follow up in all patients to determine whether cardiac prognosis is related to any specific genetic abnormality

Nephrotic Syndrome is a frequent cause of chronic kidney disease in children. Patients who are unresponsive to treatment with corticosteroids are further categorized as having steroid resistant nephrotic syndrome (SRNS). Renal biopsy in SRNS patients often reveal the histological lesion of focal segmental glomerulosclerosis (FSGS).

Genetic research has identified mutations in specific podocyte proteins, which may lead to the development of steroid resistant nephrotic syndrome. In addition to being expressed in the fetal adult kidney, human podocin mRNA is also expressed in the fetal heart tissue. Multiple case reports have described an association between cardiac abnormalities and familial FSGS. These findings suggest that this gene may be involved in the pathogenesis of cardiac abnormalities seen in this population.

The objectives of this study is to:

* Perform genetic analysis to define the prevalence of each of the known podocyte gene mutations in an unselected cohort of patients with FSGS
* Perform a comprehensive assessment of cardiovascular status to determine the incidence of any cardiac abnormalities in patients with FSGS
* Determine if patients with mutations in specific podocyte proteins are more likely to have cardiovascular abnormalities
* Initiate long-term follow up in all patients to determine whether cardiac prognosis is related to any specific genetic abnormality

Eligibility Criteria:
Inclusion Criteria:

* Age 6 months - 21 years
* SRNS, defined as failure to achieve remission in proteinuria after 4-6 weeks of daily steroid therapy in accord with ISKDC guidelines
* GFR \> 30 ml/min/1.73 m\^2
* Renal disease diagnosed based on kidney biopsy

Exclusion Criteria:

* Secondary FSGS
* Prior renal transplantation
* Congenital extra-renal abnormalities
* Significant structural cardiac abnormalities
* pulmonary, hematologic, malignancy, or immune-related disease
* inability to maintain adequate follow-up
Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Confirmed diagnosis of AML as proven by bone marrow biopsy
* Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not eligible for conventional chemotherapy
* ECOG performance status of 0-2
* Recovered from toxicities of prior chemotherapy

Exclusion Criteria:

* History of pancreatitis
* Active alcohol abuse
* Taken bexarotene in the past
* WBC \> 10,000/uL at time of enrollment
* Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose Mylotarg
* Significant organ disfunction: total bilirubin \> 3x ULN, AST or ALT \>3 x ULN, creatinine \> 3 mg/dL, on blood pressure supporting medications or mechanical ventilation
* Active participant in any other investigational treatment study for AML
* Life expectancy of less than 1 month
* Use of blood growth factors (G-CSF, GM-CSF, Aranesp, erythropoietin, or Neumega) within 1 week prior to treatment initiation
* Uncontrolled hyperlipidemia
* Known history of HIV
* Known active CNS involvement with AML
* Women of childbearing potential or active breast feeding
Role of ST2 in Acute Pancreatitis

Acute pancreatitis is characterized by an inflammatory storm which regulatory pathways are not well known. The IL-1 cytokine family is activated early during acute pancreatitis and secretion of alarmins is speculated during pancreatic necrosis. IL-33 is a member of the IL-1 family, it can act as an alarmin and its receptor, ST2, is known to sequester MyD88 which might regulate the acute pancreatitis inflammatory storm. The aim of this study is to investigate ST2 pathway in human acute pancreatitis and in murine experimental models of acute pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* Time to take blood sample less than 24h after the onset of symptoms of AP
* Two of the following: typical pain, amylase and lipase concentrations more than 3x the upper normal limit, compatible modifications on imaging techniques

Exclusion Criteria:

* Chronic pancreatitis
Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress

Poor sleep is common among college students and likely contributes to stress. The investigators developed a brief, remotely-delivered intervention and tested whether it improves sleep hygiene and reduced sleep disturbance and stress among undergraduates.

Poor sleep is common among college students and likely contributes to stress. The investigators developed a brief, remotely-delivered sleep hygiene intervention, which is delivered via the internet, and tested in a randomized controlled trial, whether it improves sleep hygiene and reduced sleep disturbance and stress in a sample of undergraduates who report wanting to improve their sleep. This study compares the novel sleep hygiene intervention to an active, matched control condition--sleep education. Baseline and 2-week follow-up questionnaires assess sleep hygiene, sleep disturbance, and stress. ANCOVAs will compare conditions at follow-up, and mediation tests will explore whether the intervention reduced stress through improved sleep.

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate students at Wayne State University
* Self-reported desire to improve their sleep

Exclusion Criteria:

* Graduate students / professional students
Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)

The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced HER2-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced breast cancer
* T \> 2 cm (any N), or any T and positive node(needle biopsy is required if tumor size is less than 2cm)
* Non-metastatic disease confirmed by computerized tomography and bone scan
* HER2 positive by IHC (+++) and/or Fish (+) according to international definitions (ASCO 2007)
* Normal left ventricular ejection fraction (LVEF)
* Indication of preoperative chemotherapy
* multifocal tumors acceptable provided that the largest tumor is Her2-positive
* ECOG 0-1

Exclusion Criteria:

* Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
* Clinically significant comorbidities such as cardiovascular diseases, COPD, renal or liver impairment, psychiatric disorders
* LVEF value below institutional limits of normal range
* Detected or suspected distant metastasis
* Neutrophils lower than 1,500/µL, platelets lower than 100,000/µL, hemoglobin lower than 10 g/dL, AST higher than 2.5x upper limit of normal (ULN), total bilirubin higher than ULN, alkaline phosphatase more than 1.5x ULN
A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.

This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication
* Body mass index (BMI) 17 to 40 kg/ m2 inclusive
* Subjects with an HbA1c between 7.0% and 10.0% at Screening
* Creatinine clearance \>30 mL/min (calculated using the Cockcroft-Gault formula)

Exclusion Criteria:

* History of type 1 diabetes mellitus
* Female subject is pregnant, lactating, or \<6 weeks postpartum
* Clinically significant cardiovascular and/or cerebrovascular disease
* Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
* Serum amylase \>=3 ×ULN and/or serum lipase \>=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
* Prior use of a GLP-1R agonist or DPP-IV inhibitor within 6 months before Screening
Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic

Retrospective study to evaluate the effect of a remote cognitive-rehabilitative intervention during the Covid outbreak in subjects with Parkinson's disease.

Mild cognitive impairment is frequent among people with Parkinson's disease. Cognitive training seems effective on cognitive status and for mitigating anxiety and depression. With COVID-19 outbreak, such therapeutic interventions were delivered online. This retrospective study was aimed at evaluating the effectiveness of an online cognitive treatment, carried out in COVID times and based on the Parkinson's-Adapted Cognitive Stimulation Therapy, on cognitive domains and mood in 18 older people with Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease: Hoehn \& Yahr's scale: 1-3 based on the UK PD Society Brain Bank
* mild cognitive impairment
* no cognitive training between March and October 2020
* presence of a family caregiver to access and use the online platform

Exclusion Criteria:

* other neurological diseases
* deep brain stimulation
* schizophrenia
* depression
* sensory deprivations that could interfere with the treatment
Reverse Shoulder Prosthesis Study

The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.


Eligibility Criteria:
Inclusion Criteria:

* Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff
* Evidence of upward displacement of the humeral head with respect to the glenoid
* Loss of glenohumeral joint space
* Functional deltoid muscle
* Patient is likely to be available for evaluation for the duration of the study
* Visual Analog Pain Scale 5 or greater

Exclusion Criteria:

* Non functional deltoid muscle
* Active sepsis
* Excessive glenoid bone loss
* Pregnancy
* Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.
* Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease.
* Prisoners
* Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
* Known metal allergy (i.e., jewelry).
* Visual Analog Pain Scale \<5.
GePheRal: Clinical Validation of the Genotypic Diagnosis of Hiv-1 Resistance to Raltegravir by Parallel Analysis of the Genotype and Phenotype Profiles of Resistance

The purpose of this study is to correlate the different patterns of resistance mutations observed in vivo in patients failing RAL treatment with the fold-change resistance determined by the phenotypic assay.

The secondary objectives are, as follows:

* to establish standardised genotypic assay for the HIV-1 pol gene region (region of interest, sensitivity, mutations involved as primary or compensatory changes, role of polymorphism present at baseline).
* to reach consensus on the algorithm interpretation of in house ex-vivo genotypic evaluations.
* to assess the genetic changes in RAL-failing patients under continuous drug pressure or drug discontinuation (dynamics of the reversion of resistance mutations).
* to evaluate in RAL resistant HIV-1 variants the changes in replication capacity (RC) (baseline vs. following-timepoints).
* to evaluate the immunological and virological trend associated with a raltegravir-regimen failure.

Eligibility Criteria:
Inclusion Criteria:

* Adult (at least 18 years of age) treatment-experienced, HIV-infected subjects of either sex and of any race, failing to a RAL-containing regimen will be enrolled in the study

Exclusion Criteria:

* none
Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice


Eligibility Criteria:
Inclusion Criteria:

* patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate)

Exclusion Criteria:

* Exclusion criteria is not provided in this study
Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Male or female, aged 18 years or older
* Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
* Prospective confirmation of KRAS mutation negative status as determined via an AZ approved laboratory
* Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy

Exclusion Criteria:

* Mixed small cell and non-small cell lung cancer histology
* Received \>1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
* Other concomitant anti-cancer therapy agents except steroids
* Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)
* The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment.
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.
* Meets at least 1 of the following criteria for disease activity:

  i) At least 1 MS relapse/attack in the previous year prior to screening.

ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening.

iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).

- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.

Exclusion Criteria:

* Diagnosis of progressive forms of MS.
* Active or chronic disease of the immune system other than MS.
* Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.
* Other protocol-defined Inclusion/Exclusion criteria apply.