cyrilzakka/clinical-trials huggingface dataset:
Couple-Based Treatment for Alcohol Use Disorders and Post-Traumatic Stress Disorder

The purpose of this study is to develop and test a couple-based treatment for Veterans with an alcohol use disorder and post-traumatic stress disorder.


Eligibility Criteria:
Inclusion Criteria:

* Veteran must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) criteria for current (past 12 months) alcohol abuse or dependence and alcohol must be the Veteran's primary substance of abuse as determined by a clinical algorithm (Fals-Stewart, Stappenbeck et al, 2004);
* Veteran must meet DSM-IV criteria for current (past month) PTSD;
* Veteran consumed alcohol in the past 90 days;
* couple must be married to or living with their current partner for at least 1 year;
* Veteran agrees to a goal of abstinence from drugs at least for the duration of the 15-week study-based treatment;
* Veteran agrees to the goal of abstaining from alcohol or consuming alcohol within low risk drinking guidelines during the duration of the 15-week study-based counseling;
* Veteran agrees to forego other treatment for alcohol-related disorders except for self help meetings (e.g., AA) or treatment required for a clinical emergency or clinical deterioration for the duration of the 15-week study based treatment;
* Veteran agrees to forgo other PTSD treatment except for treatment required for a clinical emergency or clinical deterioration for the duration of the 15-week study based treatment;
* couple agrees to forgo other couple-based counseling for the duration of the 15-week study based treatment except for treatment required for a clinical emergency or clinical deterioration;
* partner does not meet DSM-IV criteria for current (past 12 month) substance use disorder (other than nicotine)
* partner does not meet DSM-IV criteria for current (past month) PTSD.

Exclusion Criteria:

* Veteran has dependence on alcohol or other drugs that requires inpatient treatment or medical detoxification (as indicated by daily heavy use or use to prevent or deal with withdrawal symptoms) - after completing detoxification, Veteran may be eligible for the study;
* Veteran or partner are at immediate risk for suicide or homicide (current plan or intent);
* Veteran or partner exhibit a history of suicide or homicide attempt in the past year;
* Veteran is participating in a methadone maintenance or suboxone maintenance program and is seeking treatment for adjunctive outpatient services;
* Veteran or partner meets DSM-IV criteria for a current organic mental disorder, schizophrenia, delusional (paranoid) disorder, or any of the other psychotic disorders.
ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION

H pylori is an important cause of chronic gastritis and other complications. There is a decline in eradication rate for H pylori owing to multiple factors including drug resistance. We compare the effect of the addition of bismuth to the standard triple therapy in a randomized control trial.

Subjects were randomized into two arms. Arm A received triple therapy including amoxicillin, clarithromycin, and omeprazole and Arm B received quadruple therapy adding colloidal bismuth subcitrate. Both arms received treatment for two weeks.

The study is a 2-arm, prospective, randomized, non-inferiority, unblinded, parallel design trial. The primary end point is post-treatment result after triple or quadruple therapy. Secondary endpoints included the nature and frequency of side effects compared between the two arms. The study protocol was approved by the ethical review committee of the university.

Patients with dyspeptic symptoms who had H pylori infection, diagnosed through positive Stool for H pylori antigen or presence of H. pylori organism in the histopathology of gastric mucosal biopsy, attending outpatient department of two campuses of the University Hospital were included in this study.. Group A received standard triple therapy for H. pylori eradication for a total 14 days and group B received bismuth-based quadruple therapy for H pylori eradication for the same period. The triple regimen was defined as a combination of amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose. Quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily, in addition. H. Pylori status was checked routinely after 6 weeks by Stool sampling for H, pylori antigen. Subjects were counseled to stop taking PPI or any antibiotic 2 weeks before stool H. pylori antigen testing. Eradication of H pylori was defined as lack of detection of H pylori antigen in the stool via ELISA method after triple or quadruple therapy.

Eligibility Criteria:
Inclusion Criteria:

Patients with dyspeptic symptoms who had H pylori infection, diagnosed through positive Stool for H pylori antigen or presence of H. pylori organism in the histopathology of gastric mucosal biopsy, attending outpatient department of two campuses of the University Hospital were included in this study

Exclusion Criteria:

Exclusion criteria were patients with age less than 12 years, age more than 80 years, recent antibiotic use, and treatment-experienced patients, where H. pylori couldn't eradicate after treatment, chronic illnesses with multiple comorbid for example, chronic liver disease, chronic kidney disease or terminal illness etc, pregnancy and allergy to any of the regimen components.
Open Sinus Lift Technique With Simultaneous Implantation Using Platelet Rich Fibrin (PRF) Versus Nano-crystalline Hydroxyapatite

Evaluation of bone quantity in open sinus lift technique with space maintaining using platelet rich fibrin (PRF) as sole augmentation material versus nano crystalline hydroxyapatite with simultaneous placing of implants.

Evaluation of bone quantity in open sinus lift technique with simultaneous implantation using platelet rich fibrin (PRF) versus Nano-crystalline Hydroxyapatite as sole grafting material in patients with atrophied posterior maxillary ridge which provides a new modality for treatment of patients with atrophied posterior maxillary ridge with least cost and a much easier way using platelet rich fibrin (PRF) as substitution to bone graft

Eligibility Criteria:
Inclusion Criteria:

* All patients should be seeking for implant supported prosthesis in posterior maxilla bilaterally
* All patients should have atrophied posterior maxillary ridge with the maximum height of the alveolar bone is from 3 mm to 5 mm

Exclusion Criteria:

* Ongoing steroid therapy;
* Uncontrolled diabetes;
* Recent cardiovascular diseases;
* Inflammation of the maxillary sinus;
* Previous radiant therapy for neoplastic pathologies
* Patient who have had previous failed sinus augmentation, or exhibited pathological finding or had a history of maxillary sinus disease or operations or whose medical condition might increase surgical risk of the research protocol were excluded.
Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection

The goal of this observational study is to determine the prevalence of hepatitis D virus (HDV) and the distribution of the HDV genotype in patients with chronic hepatitis B infection. It will also identify factors related to hepatitis D virus infection, such as characteristics of the study sample, vaccination history, drug use affecting hepatitis, family factors, environment, and lifestyle.

This study will be conducted at Tam Anh General Hospital, Bach Mai Hospital and Tam Anh TP. Ho Chi Minh General Hospital.

Participants will be interviewed directly through a questionnaire to collect some information related to epidemiological risk factors. A blood sample will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 16 years old undergo testing at the Testing Center of Tam Anh General Hospital or Tam Anh TP. Ho Chi Minh General Hospital, with chronic hepatitis B HBsAg (+) standards for six months or over or HBsAg (+) combined with HBcAb total (+) and HBcAb-immunoglobulin M (-).
* Patients ≥ 16 years old with chronic hepatitis B come to be examined or are inpatients at the Gastroenterology - Hepatobiliary Center of Bach Mai Hospital, diagnosed with hepatocellular carcinoma, and cirrhosis

Exclusion Criteria:

* Patients do not agree to participate in the study or refuse to sign a written informed consent.
A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.


Eligibility Criteria:
Inclusion Criteria - Heart Failure Group:

* Adult 18 years and older.
* English speaking.
* Has a qualifying heart failure indication for center-based cardiac rehabilitation.

Inclusion Criteria - Healthy Control Group:

* Adult 18 years and older.
* English speaking.
* Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex.

Exclusion Criteria:

* HF patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program.
* Participants unable/unwilling to provide informed consent.
* Uremia, history of allergy to iodides. Impaired renal function.
* Creatinine value greater than 1.3 mg/dL (via clinical record within the past 6 months).
* Diagnosis of liver disease.
Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice

MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age 19-40 years at the time of Mirena IUD insertion
* Using Mirena only for contraception indication
* Never having used the product before
* No heavy menstrual bleeding diagnosed
* Have signed informed consent to participate in this study

Exclusion Criteria:

* Nulliparous
* Pregnancy
* Mirena's contre-indication
* Mirena for HMB
* Abnormal bleeding pattern
Bariatric Surgery and Pharmacokinetics of Candesartan

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on candesartan are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients

The main purpose of this study is to investigate the efficacy and safety of XW003 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone

In this Phase 3 study, eligible participants will be randomized in a 2:2:1:1 ratio to receive once-weekly subcutaneous XW003 (high or low dose) or volume matching placebo as an adjunct to lifestyle intervention for 24 weeks. The core treatment phase will be followed by a 28-week open-label period where all participants receive XW003.

Eligibility Criteria:
Inclusion Criteria:

1. Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures.
2. Sex: male or female; Age: 18 to 75 years, inclusive
3. BMI: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive
4. Have been diagnosed with T2DMthat is inadequately controlled with at least 3 months of diet and exercise prior to screening.
5. HbA1c ranging from 7.5% to 11.0% at screening, inclusive
6. FPG ≤13.9 mmol/L at screening.

Exclusion Criteria:

1. History of type 1 or other types of diabetes mellitus.
2. Use of any GLP-1 analogue during the 3 months preceding to screening.
3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening.
4. History of acute or chronic pancreatitis or high risk factors for pancreatitis.
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
6. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
7. History of heart attack, stroke, or congestive heart failure of Grade 3 or 4 in the past 6 months.
Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation

Atypical Facial Pain is a chronic condition and presents controversies during diagnostic and treatment, between specialist not have consensus about the pathophysiology. It is possible consider this entitie a potential neuropathic cause without pathological signs. It knows the repetitive transcranial magnetic presents good results in the treatment of chronic pain coditions. The aim this study is evaluated the thresholds and excitability cortical in patients with AFP and verify the patterns of improvement in pain for patients undergoing rTMS compared to controls, as well as the therapeutic response to neuromodulation procedures. This enroll 20 patients with DAF and 20 controls treated with rTMS (5 sessions) and evaluated through questionnaires (EDOF clinical record, McGill Pain Questionnaire, Visual Analogue Scale, Inventory of symptoms of neuropathic pain, neuropathic pain DN4 questionnaire, SF -36, brief pain inventory). At the end of the data will be statistically analyzed and expressed as mean and standard deviation, and analyzed by Student's t test, analysis of variance (ANOVA), Tukey-Kramer and Pearson correlation. The level of significance is 5%. The results will be published in journals indexed in the area both nationally and internationally and presented at conferences and scientific meetings.


Eligibility Criteria:
Inclusion Criteria:

* Fulfill criteria of Atypical Facial Pain by International Headache Society
* Signed Term of Informed Consent

Exclusion Criteria:

* Trauma of Skull, epilepsy don't treated,
* Use of medications decrease the seizure threshold
* Patients in use of drugs, how cocaine and alcohol
* neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
* Pregnant or lacting women
Hypofractionated IMRT With Temozolomide for HGG

To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed HGGs after surgery.

Primary endpoint: progression free survival (PFS), Overall Survival (OS) and Toxicity.

Secondary endpoint: to evaluate Quality of life (QoL) of patients after surgery, concomitant chemoradiotherapy and adjuvant chemotherapy through neuropsychological examination.

We designed a study of a hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc approach. The potential advantage of this approach is to deliver a more selective irradiation to tumor's target with reducing dose to normal brain and to allow to deliver a higher dose, optimizing the therapeutic window

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Karnosky performance status (KPS) ≥60
* Patients aged \>70 years with KPS ≥80
* Histopathologically confirmed of HGG
* Estimated survival ≥ 3 months.
* Multifocal tumor
* Normal liver, Kidney and bone marrow function
* Written informed consent

Exclusion Criteria:

* Prior radiation therapy
* KPS ≤ 60
* Age \> 70 years and KPS \< 70
* Other primary cancer
* Pregnant women
Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania

A prospective randomized double blinded placebo controlled comparative trial will be performed at HIV clinic of the Muhimbili National Hospital/MUCHS where 220 HIV positive patients presenting with oropharyngeal candidiasis (OPC) on antiretroviral (ARVs) treatment or not will be included.

The aim of this study is to compare the efficacy and safety of single dose fluconazole (750mg) and two weeks course of fluconazole (150mg once daily)in the treatment of OPC in HIV positive patients. It is hypothesised that the two regimens are equally effective in the treatment of OPC.

A structured standard questionnaire will be used to systematically collect essential data including demography, treatment history and concomitant infections and treatment.

General and oral examination, collection of oral isolates, mycological, hematological and biochemical investigations will be done at baseline and at end of treatment day 13-14.

All Patients will be followed up to 30 days after end of treatment for relapse

Eligibility Criteria:
Inclusion Criteria:

* HIV infection (as determined by positive ELISA and confirmed by Western blot)
* 18 years of age and above
* clinical picture of OPC, characterized by creamy, white, curd like patches, removable by scraping or by typical erythematous lesions (smooth red patches) on the oral mucosa, hard or soft palate and/or dorsal surface of the tongue; and microbiologically by visualization of yeast cells in Potassium hydroxide (10% KOH) preparations prepared from swab of visible lesions and confirmed positive Candida species culture

Exclusion Criteria:

* Patients who are currently receiving antifungal therapy or who had received such treatment within three days prior to enrollment in this study
* History of allergy to azole derivatives
* Abnormal liver function tests defined as alanine aminotransferase (ALT), aspartate aminotransferases (AST), or total bilirubin greater than three times the upper limit of normal; or clinical evidence of significant hepatic or renal disease within two months prior to enrollment
* Inability to tolerate oral drug administration; pregnancy or breast feeding; life expectancy of less than four weeks
* Participation in another drug study at the time of enrollment, treatment with drug which interact with fluconazole, such as vitamin K antagonists, warfarin, sulfonylurea anti-diabetic agents, rifampicin, phenytoin, isoniazid, carbamazepine and cisapride
* Documented systemic fungal infections, symptoms suggestive of esophageal candidiasis such as retrosternal chest pain, dysphagia or odynophagia unless this condition has been ruled out by endoscopic examination.
* Patients with history of alcohol abuse, drug addiction and psychiatric disorder, inability to cooperate and poor motivation will be excluded from the study.
Defibrotide for the Treatment of Severe COVID-19

The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.

This study is a prospective, single-arm, two-cohort, phase 2 pilot study that will evaluate the safety and efficacy of defibrotide in clinically severe COVID-19. The defibrotide dose that is approved by the FDA for the treatment of post-HSCT VOD/SOS (6.25 mg/kg IV q6 hours) will be used.

Cohort 1 will consist of patients with COVID-19 pneumonia confirmed by PCR and radiography, who are hospitalized with an oxygen requirement (either supplemental O2 or mechanical ventilation), are not on therapeutic dose anticoagulation, and require no more than one vasopressive agent to maintain hemodynamic stability. Cohort 2 will consist of patients with COVID-19 pneumonia confirmed by PCR and radiography, who are hospitalized in the ICU and are at elevated risk of hemorrhage and/or hypotension, the former defined as a requirement for therapeutic dose anticoagulation for active thrombosis, ECMO, or CRRT, and the latter defined as a requirement for two vasopressive agents to maintain hemodynamic stability.

In cohort 2 only, a 6+6 dose de-escalation design will be utilized, in which if 2 of 6 DLTs are experienced in the first 6 subjects, the dose will be reduced from 6.25 mg/kg IV q6hrs to 10mg/kg/d CIVI. If there are 0 or 1 DLTs in the first 6 subjects at the FDA-approved dose, another 6 subjects will be enrolled at the same dose. Grade 3/4 hemorrhage and significant new hypotension will be considered DLT's.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.
3. Radiographic evidence of bilateral pulmonary infiltrates.
4. A life expectancy of at least 24 hours.
5. Score of 4-7 on the WHO ordinal scale.
6. Prophylactic dose anticoagulation is allowed for enrollment into cohort 1. Therapeutic dose anticoagulation for active thrombosis, ECMO, and/or continuous renal replacement therapy (CRRT) is allowed for enrollment into cohort 2 if there is no evidence of bleeding after at least 24 hours of anticoagulation.
7. Patient or surrogate able to provide informed consent

Exclusion Criteria:

1. Clinically significant acute bleeding.
2. Concomitant use of thrombolytic therapy (e.g. t-PA).
3. Hemodynamic instability, defined as a requirement for \>1 vasopressor agent for enrollment into cohort 1, and a requirement for \>2 vasopressor agents for enrollment into cohort 2
4. Known allergy or hypersensitivity to DF.
5. Pregnant or lactating.
Assessing Coronary Non-Culprit Plaque Early with Start of PCSK9 Inhibitors in Acute Myocardial Infarction (ACCESS-AMI)

This study is planned to start on January 2024.

The goal of this clinical trial is to learn whether the perioperative administration (within 24 hours before or after primary PCI) of PCSK9 inhibitors can ameliorate plaque progression and adverse outcomes in patients with acute myocardial infarction (AMI). The main questions it aims to answer are:

Can perioperative PCSK9 inhibition improve the plaque stability and inflammation of perivascular adipose tissue (index of plaque attenuation（IPA ）and perivascular fat attenuation index（FAI）) of non-target lesions? Researchers will compare PCSK9 inhibitors with statin plus ezetimibe therapy to evaluate the potential of PCSK9 inhibitors in mitigating the progression of non-target lesion plaques and reducing adverse cardiovascular events in patients with AMI.

Participants will:

Take PCSK9 inhibitors every two weeks or daily statin plus ezetimibe therapy. Conduct a follow-up examination with optical coherence tomography (OCT) or coronary computed tomography angiography (CTA) after 12 months.

Record the occurrence of major adverse cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old.
2. Admitted to hospital for acute myocardial infarction (STEMI, NSTEMI) and successfully underwent PCI of the infarct vessel.
3. Coronary angiography revealed two non-infarct-related arteries with non-blocking lesions (diameter stenosis of 40-70%).
4. Able to sign informed consent.
5. Willing to undergo 1-year follow-up.

Exclusion Criteria:

1. Left main artery disease or severe coronary artery calcification;
2. Hemodynamic instability or uncontrolled arrhythmia;
3. History of coronary artery bypass;
4. severe renal insufficiency, active liver disease or liver insufficiency, hematological disease, metabolic or endocrine dysfunction, systemic infection, active malignant tumor and other potentially life-threatening diseases, or the expected survival time is \< 1 year;
5. Received any PCSK9 inhibitor treatment within the previous 3 months;
6. Pregnant or nursing women or women planning pregnancy;
7. The researcher determined that it was not suitable for inclusion in the group.