cyrilzakka/clinical-trials huggingface dataset:
ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking

The purpose of this study is to describe the characteristics of the smoker who wants to quit and his/her treating physician, in addition to determine the safety and effectiveness of Champix in the real-world setting of smokers in routine clinical practice.

Sampling Method Description: Patients enrolled after being prescribed Champix for smoking cessation at the sole discretion of treating physician and patient.

Eligibility Criteria:
Inclusion Criteria:

* All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion

Exclusion Criteria:

* All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion
A Randomized Two-Arm Proof of Concept Study Testing a Novel Approach to Exercise Promotion Based on Affect-regulation

The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are:

1. Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up?
2. What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription.
3. What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription.

All participants will:

* Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription.
* Participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. These meetings are the same for all participants.
* Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer
* \<60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6- months
* Own an Android or iPhone smartphone (or tablet) and willing to use it to complete app-based surveys during assessment periods
* Willing to wear the ActiGraph monitor during assessment periods
* Access to internet to complete REDCap survey assessments

Exclusion Criteria:

* Non-English speaking/not able to read English
* Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
* Currently pregnant
* History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
* Evidence of moderate-severe depressive symptoms (indicated by a score≥ 10 on the Patient Health Questionnaire-8)
* Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener)
* Evidence of clinically significant substance use as indicated by a score of ≥ 2 on the CAGE- AID screener.
Minocycline in Patients With Huntington's Disease

This is a study to determine whether treatment with minocycline is safe and tolerable in patients with Huntington's disease (HD) and whether minocycline reduces symptoms of HD in these patients.

Huntington's disease (HD) is a dominantly inherited disorder. It is uniformly progressive and there is no known effective treatment or cure. The pathogenesis is largely unknown; however, recent studies implicate caspase activation, glutamate excitotoxicity, and free radical toxicity as possible causes of HD. Pharmacological agents that block these pathways may be therapeutic in HD. Minocycline is an antibiotic that also inhibits caspase-1 and caspase-3 expression, and inducible nitric oxide synthetase activity, which are factors that may play an important role in the mechanisms of neuropathology in HD.

Two dosages of minocycline or placebo will be given to ambulatory patients with HD over an 8-week period and the tolerability will be compared. Additional measures of safety and the change in motor, behavior, cognitive, and function features will be examined.

Eligibility Criteria:
Inclusion criteria:

* Clinical features of Huntington's disease (HD) and a confirmatory family history of HD and/or a CAG repeat expansion of at least 37
* Stage I, II, or III of illness (TFC greater than or equal to 5)
* Ambulatory and not requiring skilled nursing care
* Patients must use effective birth control
* Concurrent psychotropic medications must be at stable dose for at least 4 weeks prior to study
* WBC count at least 3,800/mm3
* Creatinine no greater than 2.0
* Alanine aminotransferase (ALT) no greater than 2 times upper limit of normal

Exclusion criteria:

* Prior minocycline use within 2 months of baseline visit
* History of known sensitivity or intolerability to minocycline or any other tetracycline
* History of vestibular disease
* Use of any investigational drug within 30 days of baseline visit
* Treatment with any drug that may cause lupus-like symptoms (e.g., procainamide or hydralazine) within 4 weeks of baseline visit
* Pregnant or nursing
* Underlying hematologic, hepatic, or renal disease
* Evidence of unstable medical illness
* Illness that requires use of coumadin
* Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression within 90 days of baseline visit, or suicidal ideation
* Substance (alcohol or drug) abuse within 1 year of baseline visit
* History of systemic lupus erythematosis (SLE) or a history of SLE in a first-degree relative
* Positive ANA screening (at or above 1:80)
Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.

Helicobacter pylori infection is associated with gastric cancer in epidemiological studies. However, it is still unknown whether H. pylori eradication is useful and required to prevent gastric cancer.

Gastric cancer risk is increased in family members of gastric cancer patient. Though there is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family members of gastric cancer, current European guideline recommends H. pylori eradication in first-degree relatives of gastric cancer patients.

In this study, the investigators will evaluate whether H. pylori eradication can reduce gastric cancer risk in the first-degree family members of gastric cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy
* Informed consent should be signed

Exclusion Criteria:

* Gastric cancer history
* Other malignancy within the past 5 years
* Hereditary cancer family member (HNPCC, FAP)
* Peptic ulcer history
* Peptic ulcer, esophageal cancer, gastric cancer case found at EGD
* H. pylori eradication treatment history
* Previous serious side effect to antibiotics
* Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
* Pregnant or nursing women
* Psychiatric disorder that would preclude compliance, alcoholics
* Refuse informed consent
Intravenous Thyroxine for Heart-Eligible Organ Donors

This randomized controlled trial will evaluate whether intravenous thyroxine infusion given to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more hearts transplanted than saline placebo

Background: Brain death frequently induces hemodynamic instability and cardiac stunning. Impairments in cardiac performance are major contributors to hearts from otherwise eligible organ donors not being transplanted. Deficiencies in pituitary hormones (including thyroid stimulating hormone) may contribute to hemodynamic instability and replacement of thyroid hormone has been proposed as a means of improving stability and increasing hearts available for transplantation. Intravenous thyroxine is commonly used in donor management. However, small controlled trials have not been able to demonstrate efficacy.

Methods: This multicenter study will involve organ procurement organizations (OPOs) across the country. A total of 800 heart-eligible brain dead organ donors who require vasopressor support will be randomly assigned to intravenous thyroxine for at least 12-hours or saline placebo. The primary study hypothesis is that thyroxine treatment results in more hearts transplanted. Additional outcome measures are time to achieve hemodynamic stability (weaning off vasopressors) and improvement in cardiac ejection fraction on echocardiography.

Discussion: This will be the largest randomized controlled study to evaluate the efficacy of thyroid hormone treatment for organ donor management. By collaborating across multiple OPOs, it will be able to enroll an adequate number of donors and be powered to definitively answer the critical question of whether treatment increases hearts transplanted and/or provides other hemodynamic benefits.

Eligibility Criteria:
Inclusion Criteria:

* Declared dead by neurologic criteria (brain dead)
* Authorization for organ donation and research
* On one or more vasopressors and/or inotropes

Exclusion Criteria:

* Brain death declared more than 24 hours prior
* Only vasopressor is vasopressin
* Weight \< 45 kg (100 lbs)
* Known coronary artery disease or history of myocardial infarction
* Known valvular heart disease
* Prior sternotomy or cardiac surgery
* Donor at VA hospital
* Received intravenous or oral thyroxine within past month
* Known HIV+ status
* Other reason donor is unable to receive study drug (determined by on-site personnel)
TCR-Redirected T Cell Treatment in Patients With Recurrent HBV-related Hepatocellular Carcinoma Post Liver Transplantation

This is a single-arm and open-label study to assess the safety, tolerability and primary efficacy of the HBV specific T cell receptor (HBV/TCR) redirected T cell in patients with recurrent Hepatitis B virus (HBV) related hepatocellular carcinoma post liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis as hepatocellular carcinoma (HCC).
2. Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation.
3. Seropositive for hepatitis B surface antigen, or presence of HBV DNA or HBV RNA.
4. HLA profile matching with HLA-class I restriction element of the available T cell receptors.
5. ECOG performance status ≤ 2.
6. Laboratory criteria:

   1. Liver function: ALT and AST ≤ 5 of upper limit of normal (ULN), TBIL ≤ 3 x ULN.
   2. Neutrophil cell number ≥1.5×10\^9/L.
   3. Platelet count ≥100×10\^9/L.
7. Ability to provide informed consent.
8. Willing and able to comply with all study procedures.

Exclusion Criteria:

1. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment.
2. Likelihood to require steroid treatment during the period of the clinical trial.
3. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples.
4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
5. Administration of any other cell therapy, including NK, CIK, DC, CTL, CAR- T, stem cells or combined therapy of the kind within 28 days prior to start of treatment.
6. Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study.
Cell-free DNA Quantification for Predictive Marker of Palliative Chemotherapy

This study is design to address, as follows:

1. correlation between fluorescence-based CFD measurements and tumor burden (primary tumor size, number of metastatic sites)
2. fluorescence-based CFD measurements and changes are related to tumor response. Based on the results of this study, the role of fluorescence-based CFD as a predictive biomarker for palliative chemotherapy is to be confirmed.

* It is important to check the response to chemotherapy. Currently, it is mostly evaluated as a radiologic response or, rarely the change of tumor markers.
* In the case of radiologic response tests at intervals of 6-8 weeks, there are cases where the economic burden and radiation exposure risk, additionally evaluation lesion is lack in a few case. Except for prostate cancer and ovarian cancer, the majority of carcinomas do not have cancer markers for assessing treatment response. Therefore, there is a need for biomarkers that can predict the response of anticancer treatment.
* In many studies, it has been reported that various types of circulating cell free DNA (CFD) are increased in various cancer types.
* Recently, a fluorescence based CFD method that can directly measure nucleic acids without a DNA extraction process has been developed, which makes testing simpler and more economical, and can be conveniently applied to cancer diagnosis and treatment response.
* This study is plan to evaluate the relationship between fluorescence-based CFD and treatment response in patients starting palliative chemotherapy, and check whether it can serve as a response evaluation for palliative chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed initially metastatic or recurrent cancer who are expected to undergo primary palliative chemotherapy (patients who relapse after adjuvant chemotherapy before/after existing surgery can also be enrolled regardless of period)
* Patients with definitive tumor burden (Patients who do not have residual lesions due to metastasectomy are excluded. However, measurable lesions according to RECIST 1.1 are not mandatory, and evaluable lesions are possible)
* ECOG PS 0-2
* Adequate bone marrow, renal function, liver function to receive chemotherapy
* Patients with informed consent form

Exclusion Criteria:

* Patients with treating antibiotic treatment within 3 days of study enrollment due to overt or suspected infection
* Other serious illness or medical condition
Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers

The primary objective of this study is to evaluate the safety and tolerability of a 10-dose regimen of vesatolimod in HIV-1 infected controllers on antiretroviral treatment (ART) and during analytical treatment interruption (ATI) following vesatolimod dosing.


Eligibility Criteria:
Key Inclusion Criteria:

* Plasma HIV-1 ribonucleic acid (RNA) levels \< 50 copies/mL at screening
* Chronic HIV-1 infection (for ≥ 6 months) prior to ART initiation
* Pre-ART Plasma HIV-1 RNA set point between 50 and ≤ 5,000 copies/mL measured within two years prior to ART initiation
* On ART for ≥ 6 consecutive months prior to screening
* Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 6 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.
* No documented history of resistance to any components of the current ART regimen
* Availability of a fully active alternative ART regimen, in the opinion of the Investigator, in the event of discontinuation of the current ART regimen with development of resistance.
* Hemoglobin ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)
* White Blood Cells ≥ 2,500 cells/μL
* Platelets ≥ 125,000/mL
* Absolute Neutrophil Counts ≥ 1000 cells/μL
* Cluster of Differentiation 4 (CD4)+ count ≥ 500 cells/μL
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or bilirubin ≤ 2 × upper limit of normal (ULN)
* Estimated glomerular filtration rate ≥ 60 mL/min
* No autoimmune disease requiring on-going immunosuppression
* No evidence of current hepatitis B virus (HBV) infection
* No evidence of current hepatitis C virus (HCV) infection (positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable)
* No documented history of pre-ART CD4 nadir \< 200 cells/μL (unknown pre-ART CD4 nadir is acceptable)
* No history of opportunistic illness indicative of stage 3 HIV
* No acute febrile illness within 35 days prior to Pre-Baseline/ Day -13

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Using Implementation Intentions to Increase Safe Sex Practices in MSM

The purpose of this study is to assess the utility of the Theory of Planned Behavior in predicting condom use among men who have sex with men. It also aims to assess the utility of two interventions, one known as "implementation intentions", the other involves the practice of a planning task known as "the tower of Hanoi", in increasing condom use in this population.

The purpose of this study is two-fold. The first part of the study aims to assess the validity of a theory of health behaviour, known as the Theory of Planned Behaviour (TPB) in predicting condom use in and Australian sample of men who have sex with men (MSM). The TPB states that a person's intention to use condoms is the best predictor of their actual condom use behaviour. The TPB indicates that intention is predicted by an individual's attitude towards condom use, whether they believe their family and friends feel that they should use condoms (known as "subjective norm"), and how much control the person feels that they have over condom use (known as perceived behavioral control). In order to measure this, participants will be asked to complete questions regarding their attitudes, subjective norm, perceived behavioral control, intention towards condom use, and actual condom use behavior. It is expected that the TPB will be successful in predicting condom use in this population.

The second part of the study aims to assess whether two different interventions are effective in increasing condom use among men who have sex with men (MSM).

The first intervention is known as "implementation intentions" and asks that participants specify when, where and how they might increase their condom use in the future (e.g. by buying condoms). It is predicted that in making this plan that the likelihood of preparing to use condoms will increase as will actual condom use.

The second intervention asks participants to practice a task several times per week that is thought to improve planning ability. The task is known as "The Tower of Hanoi" which is a computer based program that requires participants to shift discs across three different pegs in and ordered and planned way. It is thought that this practice can improve an individual's planning ability. It is thought that this planning ability may then generalise to other tasks such as planning to use condoms. It is predicted that this intervention will increase actual condom use among this population.

A control group that receives no intervention will also be employed.

Measures of the TPB will be taken at baseline and three months after the interventions have taken place to assess any changes to the variables thought to predict condom use, and any changes in condom use behavior. It is expected that the the TPB variables will all increase in the intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Men who have sex with men
* Adults (over 18 years old)
* Sexually active

Exclusion Criteria:

* Women
* Minors (under 18 years old)
* Those who have never been sexually active
* Those unable to provide consent
Medical Nutrition Formulations Enriched with Postbiotics for the Management of Gastrointestinal Disorders

Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial


Eligibility Criteria:
Inclusion Criteria:

* Inpatients of the centre

  * Diagnostic of diarrhoea: increase in daily faecal weight \> 200 g (as per the Centre protocol).
  * Subjects who as per the Centre protocol require Oral rehydration therapy
  * Patients with the ability to take the study product orally

Exclusion Criteria:

* History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.

  * History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
  * Patients in situation of last days
  * Amytriptilin and masalazine treatment (anti-depressives)
  * Laxatives
Geriatric Assessment Screening Tool for the Identification of At-Risk Older Adults Who Are Undergoing Cancer Treatment

This phase II trial investigates how easy it is to incorporate a nursing led geriatric assessment screening tool into a busy oncology practice, in order to identify at-risk older adults being evaluated for cancer treatment. This screening tool may help identify at-risk patients who can be referred for more in depth assessment, allowing for the creation of an individualized treatment plan that puts the patient's safety and personal goals as a priority.

PRIMARY OBJECTIVE:

I. To determine the feasibility of training nurses to administer the Geriatric 8 (G8) screening tool in an oncology practice, to identify older patients (\> 65 years old \[y/o\]) that would benefit from a more extensive Comprehensive Geriatric Assessment (CGA).

SECONDARY OBJECTIVE:

I. To report the positive predictive value of the G8 screening tool with the final frailty designation determined by the Comprehensive Geriatric Assessment completed in patients referred to the Senior Adult Oncology Center (SAOC).

OUTLINE:

PHASE I:

Registered Nurses receive training on how to administer the G8 screening tool utilizing an Epic flowsheet to patients using a self-directed education module and by direct assessment by a geriatrician.

PHASE II:

Patients complete the G8 screening tool questionnaire over 10 minutes as part of their standard initial assessment, and their answers are entered into their electronic health record (EHR) flowsheet. Patients who score =\< 14 on the G8 are referred for a CGA at SAOC, and these patients and their medical oncologists are made aware. Within 2 weeks of the initial screening, the results are communicated with the patient and medical oncologist at a 2-hour SAOC visit. Patients with a score of \> 15 on the G8 are made aware of their results without any referral generated.

Eligibility Criteria:
Inclusion Criteria:

* NURSES: Assigned to two designated cancer clinics at Sidney Kimmel Cancer Center (SKCC) Center City, the Renal Cell Carcinoma (RCC) and Lymphoma/myeloma clinics
* PATIENTS: 65 years and older
* PATIENTS: Diagnosis of cancer

Exclusion Criteria:

• PATIENTS: Inability to answer or have caregiver answer questions on screening tool