cyrilzakka/clinical-trials huggingface dataset:
Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia

Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.

There is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. This study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day).

Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur after one-week treatment with placebo or bupropion. During study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. After that, participants will have a 90-min period to smoke, and smoking topography will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with schizophrenia or schizo-affective disorder
* Smokes between 20 and 50 cigarettes per day
* Moderate to high nicotine dependence score
* Interest in quitting smoking

Exclusion Criteria:

* Currently trying to quit smoking
* Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics
* Alcohol or drug use disorders
* Requires certain medications
* Pregnant or breastfeeding
Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty

The number of patients requiring joint replacement is increasing due to its success in restoring function and pain relief, and the growing population of the elderly. One of the most serious complications of arthroplasty is joint prosthesis infection. Due to the absence of prospective, randomized, controlled studies, there is no consensus concerning diagnosis and treatment of prosthetic joint infections. The main objective of this trial is to evaluate the clinical efficacy of rifampin combination therapy versus monotherapy using cloxacillin or vancomycin in early staphylococcal infections after total hip and knee arthroplasty.

The study is a controlled randomized multicentre trial with 8 participating centres in Norway. We will include patients with the diagnosis of early infections (within 4 weeks post operatively)after hip or knee replacement. Patients with clinical signs of infection are scheduled for a standardized soft tissue revision. Diagnosis of staphylococci must be established by arthrocentesis or at surgical revision, and must grow in at least 2/8 cultures.The patients will randomly be assigned to antimicrobial therapy with or without rifampin by a randomization programme. Antibiotics will be given for 6 weeks. Two years follow-up. The study end points are final follow-up visit after two years or relapse of infection.

Eligibility Criteria:
Inclusion Criteria:

* Prosthetic joint infections category 2 or 3 (early post.op infections within 4 weeks).
* Diagnosis of staphylococci.
* Clinically and radiographically stable implants kept in place after revision.

Exclusion Criteria:

* Infection with other microorganisms than staphylococci.
* Less than 2 years of expected survival.
* Predictable inability to comply with the treatment and/or follow-up visits.
* Contraindication to the use of study medication including acute or chronic liver disease.
* Lack of written consent.
* Fertile women.
* Patients taking less than 80% of the study medication.
Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids

Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and available for the duration of the study
3. 14-17 years of age upon enrollment
4. Right-handed
5. In good general health as evidenced by medical history
6. Adolescent and parent/guardian are English-speaking, as study assessments are in English
7. Availability of a parent or legal guardian who is willing to provide consent and attend all study visits

Exclusion Criteria:

1. Traumatic brain injury with ongoing symptoms
2. Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay
3. MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia)
4. Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell)
5. Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder
6. Severe/unstable medical condition (e.g., diabetes, rheumatoid arthritis)
7. Current (past 1-month) use of cannabis or cannabinoid products including CBD unless willing to stop for at least 4 weeks prior to entering the study
8. Currently pregnant, lactating, or positive pregnancy test at screening visit
9. Current homicidal thoughts or suicide attempt in the past year
10. Current suicidal thoughts requiring immediate intervention
11. Concurrent use (past 6 weeks) of oral contraceptives
12. Diagnosed or probable substance use disorder (past 1-month)
13. Positive drug test at baseline visit (e.g., THC, cocaine)
14. Moderate/severe drug or alcohol use in the past 8 weeks
15. Current or recent (past 1-month) COVID-19 diagnosis or febrile illness
16. Treatment with investigational drug or intervention (past 1-month)
17. Current smoker, vaper, or tobacco or nicotine use (past 1-month)
18. Ongoing exposure to abuse
Efficacy of an Advanced Care Planning Program in Advanced Heart FAilure

An "Advanced Planning Program of Health Decisions" (APPHD) is a process of reflection and relationship between the patient, their relatives and health professionals. It is based on respect for patient's autonomy, to engage patients in making decisions about their disease so that the process is shared between the medical team, the patient and their relatives. Until now, it has not been measured whether the APPHD is effective and, therefore, really fulfills its purpose

BACKGROUND: An Advanced Care Planning (ACP) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. It is based on respect for patients' autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. Up until now, the efficacy of an ACP has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. OBJETIVES: The main objective of our study is to evaluate the efficacy of an ACP program for decision-making in patients with advanced heart failure (HF) in comparison to usual follow up and care. This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making. Secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the ACP program are fulfilled, to measure the impact of the program on patients' caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death. METHODS: randomized multicentre clinical trial at four hospitals in Madrid. Once they are included in the study, patients' allocation to groups (control vs intervention) will be made by alternative sampling. ACP will be applied to the intervention group, whereas in the Control Group usual follow-up will be carried out in HF units. All patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of ACP in patients with advanced HF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HF defined by Framingham diagnostic criteria.
* Stage C or D of the ACCF / AHA classification.
* Full capacity to decide.
* Signing of informed consent.

Exclusion Criteria:

* Cognitive impairment, measured by Mini-Mental Status Examination (\< 27).
* Presence of another disease other than HF that may severely affect the quality of life: stroke with significant residual deficit, end-stage renal failure, Child C cirrhosis, extreme obesity, haemoglobin \<8 g / dl, advanced peripheral artery disease (stage III-IV), severe thyroid or adrenal disease, neoplastic with estimated survival of less than 2 years.
* Patients who do not sign the informed consent.
Elaboration of New Generation Snacks

It is a blind randomized clinical trial of nutritional intervention in humans with a snack (seaweeds and carob), compared to a control snack without the bioactive ingredients studied but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia and Insulin resistance.

The design will consist of a double-blind randomized study in adult subjects with metabolic syndrome, who will consume snack (enriched in seaweeds and carob) (50 g / day) vs. conventional snack for 8 weeks.

All the next parameters will be measured/calculated at basal time and after 8 weeks of intervention. The next biochemical parameters will be measured: Total cholesterol, LDL cholesterol, HDL, triglycerides will be analyzed using an enzyme-colorimetric method (Roche Diagnostics , Mannheim, Germany). Glucose will be determined by the method of glucose oxidase (Glucose analyzer 2, Beckman Instruments, Fullerton, California), insulin will be determined by Elisa (ELISA Diagnostic Corporation, Los Angeles, CA) and HOMA will be calculated by the formula Matthew et al. , 1985 (HOMA = (glucose \* insulin) / 22.5). Body weight and fat mass by bioimpedance will be measured, too. Blood pressure (Systolic and diastolic blood pressure) will be measured, too. A diet records for 3 days and a satiety scale will be performed at the beginning and end of the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* presence of metabolic syndrome by (Adult Treatment Panel III) criteria

Exclusion Criteria:

* consume supplements (vitamins, minerals or other dietary components),
* non-restrictive diet
* known chronic disease (eg diabetes, cardiovascular disease, Inflammatory diseases).
* active cancer
A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced，recurrent or metastatic breast cancer with disease progression following endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:

* Has the pathologically-confirmed diagnosis of locally advanced, recurrent or metastatic, HR positive, HER2 negative Breast Cancer
* One previous line of chemotherapy for advanced/metastatic disease is allowed
* Disease Progression following endocrine therapy
* Have postmenopausal status
* Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: measurable disease or nonmeasurable bone-only disease
* ECOG: 0\~1
* Adequate organ function

Exclusion Criteria:

* Previous treatment with cytotoxic drugs within 4 weeks before enrollment
* Previous treatment with endocrine or small molecule drug tyrosine kinase inhibitor TKI within 2 weeks before enrollment
* Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant
* HER2 positive
* Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, etc
* Pregnancy or lactation
* Other conditions considered not appropriate to participate in this trial by the investigators
Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop

The purpose of this study is to gather a mixed racial group of relatively healthy male Veterans (for example, White, African-American, and Hispanic), who are at least 50 years of age. These men will be followed to see what types of diseases they develop and to determine if racial differences in lifestyle, blood test results, or genes are related to the types of diseases that are found. Diseases of particular interest are prostate cancer, other cancers, cardiovascular disease (for example, heart attacks and stroke), high blood pressure and diabetes. The group to be followed will consist of about 16,000 men recruited from about 40 VA Medical Centers across the country. Each man will be followed for at least five years depending on when he enters the study.

The purpose of this study is to gather a mixed racial group of relatively healthy male Veterans (for example, White, African-American, and Hispanic), who are at least 50 years of age. These men will be followed to see what types of diseases they develop and to determine if racial differences in lifestyle, blood test results, or genes are related to the types of diseases that are found. Diseases of particular interest are prostate cancer, other cancers, cardiovascular disease (for example, heart attacks and stroke), high blood pressure and diabetes. The group to be followed will consist of about 16,000 men recruited from about 40 VA Medical Centers across the country. Each man will be followed for at least five years depending on when he enters the study.

Participants are asked to complete a set of forms to provide a brief medical history, demographics, information on lifestyle such as physical activities, smoking, and drinking, information on diet, and information on quality of life.

Subjects will be seen on a biannual basis with follow-up telephone interviews conducted during the intervening years. Follow-up telephone interviews will be conducted at the MAVERIC Call Center while follow-up clinic visits will take place at each SELECT site. In addition, VA clinical and administrative databases will be used to augment follow-up and confirm reported events.

During follow-up visits, participants will be asked whether they experienced any medical events since the last study visit, with information on specific diagnoses including prostate cancer, lung cancer, colon cancer, other cancers, stroke, myocardial infarction, hypertension, diabetes mellitus, kidney disease, chronic prostatitis, and benign prostatic hypertrophy. Confirmation of self-reported diagnosis will be made by an examination of discharge summaries, medical records, and available diagnostic and laboratory information by an end-points committee.

Recruitment for this observational cohort will proceed in parallel with recruitment for SELECT and can use SELECT staff and resources with very little additional burden in cost or staff time.

Eligibility Criteria:
Inclusion Criteria:

* relatively healthy male Veterans
* at least 50 years old

Exclusion Criteria:

* Life expectancy of at least 5 yrs
Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma

Background: Malignant tumors may lead to a catabolic state with loss of muscle and adipose tissue. The full picture of catabolism is termed cachexia and is associated with significant morbidity and mortality of cancer patients. Although the full picture is rarely observed up to 50% of children with cancer suffer from significant malnourishment. Additionally to tumor-induced catabolism, side-effects of chemotherapy may be problematic for the patients. In this regard up to 60% of children suffer from gastrointestinal mucositis presenting with nausea, vomiting, diarrhea or constipation and abdominal pain. In the worst case, mucositis may lead to bacterial translocation with life-threatening inflammatory response. Clinically this may require a reduction of the dosage or the number of chemotherapy cycles resulting in reduced effectivity. Up to now the therapy of mucositis is only symptomatic. Recent research of the applicant has shown a significant reduction of Lactobacilli in mice with neuroblastoma (a malignant childhood tumor). The dysbiosis was associated with catabolism, increased gut permeability and inflammation. Astonishingly, chemotherapy alone also leads to a significant reduction of Lactobacilli compared to sham mice, which may be linked to the development of mucositis clinically. Overall, the intestinal microbiome seems to play an essential role in the development of tumor-associated catabolism and chemotherapy-induced mucositis.

Aim: The aim of this project is to determine if the changes in the intestinal microbiome observed in mice can also be seen in children with neuroblastoma.

Methods: One part of the study will include 10 children with neuroblastoma (inclusion after verification of the diagnosis) and 10 healthy controls. The fecal microbiome will be determined by 16S-ribosomal deoxyribonucleic acid (rDNA) pyrosequencing. Volatile organic compounds in the breath will be sampled and measured by Gas Chromatography/Mass Spectroscopy. A basic science human work package will address the question if there are differences.

In the second part serial investigations in children with neuroblastoma will assess whether or not these patients show alterations of the intestinal microbiome under chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 2-8 years
* Neuroblastoma group: verified neuroblastoma
* Control group: absence of pulmonary or gastro-intestinal disease
* Written parental informed consent obtained

Exclusion Criteria:

* Active gastro-intestinal or pulmonary disease
* Antibiotic or probiotic treatment within 3 weeks before sampling
* Negative parental informed consent
Measurements of Resting Energy Expenditure in Patients With or at Risk of Developing Graft Versus Host Disease

This study aims to show that the MedGem indirect calorimetry measurement device will be feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD will have elevated REE that is not adequately predicted by standard equations.

Chronic Graft versus Host Disease (GVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow and hematopoietic progenitor cell transplantation. In adults, it has been shown that patients with acute or chronic GVHD have an increase in their resting energy expenditure (REE), likely as a result of chronic systemic inflammation. These studies have not yet been performed in children. This study's objective is to determine the REE of pediatric patients with acute and chronic GVHD after hematopoietic stem cell transplantation (HSCT).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 7-30 years of age
* Signed informed consent
* One of the following three criteria must be met:

  * Presence of grade II or greater acute GVHD as defined by Keystone criteria
  * Presence of clinically extensive chronic GVHD as defined by the revised Seattle criteria
  * Any subject identified prior to allogeneic transplant, or following allogeneic transplant, who is at risk for acute or chronic GVHD

Exclusion Criteria:

* Inability to meet the requirements of the study procedures
* Any subject who is receiving supplemental oxygen
* Withdrawal of consent
The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm

The matrix metalloproteinase-9 (MMP-9) is considered to play a central role in abdominal aortic aneurysm (AAA) initiation. Doxycycline has direct MMP-9 inhibiting properties in vitro, and it effectively suppresses AAA development in rodents. Observed inhibition of AAA progression, and contradictory findings in human studies evaluating the effect of doxycycline therapy on aortic wall MMP-9 suggest that the effects of doxycycline extend beyond MMP-9 inhibition, and that the effect may be dose dependent.

In this clinical trial, we evaluated the effect of two weeks of low (50 mg/day), medium (100 mg/day) or high dose (300 mg/day) doxycycline versus no medication in patients undergoing elective AAA repair. The effect of doxycycline treatment on MMP and cysteine proteases, and their respective inhibitors was evaluated in an integrative approach.

Eligibility Criteria:
Inclusion Criteria:

* Elective open aneurysm repair

Exclusion Criteria:

* Severe kidney and liver dysfunction
Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components

This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.

This is a two-part, Phase 2, double-blind, placebo-controlled, randomized, multicentre study.

Subjects with a diagnosis of PD and dyskinesias in PD will complete a Screening Visit to assess eligibility to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
* Is male or female, between 18 and 85 years of age at Screening Visit.
* Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
* Has experienced dyskinesia
* Has stable peak-effect dyskinesia
* Has more than one hour of "ON" time with troublesome dyskinesia

Exclusion Criteria:

* Has undergone surgery for the treatment of PD
* Has a current diagnosis of Substance Use
* Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
* Has current seizure disorders requiring treatment with anticonvulsants.

Other criteria related to other medical conditions to be referred to the protocol.
Comparison of SMS and IVR Surveys in Tanzania

This study focuses on mechanisms to adapt the performance of interactive voice response (IVR) and short message service (SMS) surveys conducted in low-and middle-income (LMIC) setting (Tanzania) and evaluates how the two survey modalities (IVR and SMS) affect survey metrics, including response, completion and attrition rates.

Using random digit dialing (RDD) sampling technique, participants will be randomized to one of two arms : 1) IVR or 2) SMS. Participants in the first study arm will receive an IVR survey. Participants in the second study arm will receive a SMS survey. The IVR and SMS questionnaires contain a set of demographic questions and one non-communicable disease (NCD) module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes). We will examine contact, response, refusal and cooperation rates and demographic representativeness by each study arm.

Eligibility Criteria:
Inclusion Criteria:

* Access to a mobile phone
* Greater or equal to 18 years of age
* Conversant in the Swahili language

Exclusion Criteria:

* Less than 18 years of age