cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Biodistribution and Safety of [18F]MNI-958 in Healthy Subjects

The overall goal of this protocol is to evaluate the biodistribution of \[18F\]MNI-958 also known as APN-0000455 or PM-PBB3, as a tau targeted radiopharmaceutical.

The overall goal of this protocol is to evaluate the biodistribution of \[18F\]MNI-958 also known as APN-0000455 or PM-PBB3, as a tau targeted radiopharmaceutical. The specific objectives are:

* To determine the radiation dosimetry of \[18F\]MNI-958
* To assess the safety and tolerability of a single dose of \[18F\]MNI-958

Eligibility Criteria:
Inclusion Criteria:

* The participant is 18 to 55 years old.
* Written informed consent must be obtained before any assessment is performed.
* Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use a barrier contraception method for the duration of the study.
* Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
* Male subjects must not donate sperm for the study duration.
* Willing and able to cooperate with study procedures.

Exclusion Criteria:

* The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
* The subject is a currently exposed to nicotine products or had regular nicotine exposure within a six month period, to be verified by urine cotinine screening.
* History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening visit.
* The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
* The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
* Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure does not exceed the effective dose of 50 mSv, equivalent with the acceptable annual limits established by the US Federal Guidelines.
* Pregnancy or women who are breastfeeding, lactating or nursing.
* Unsuitable veins for repeated venipuncture.
* History of immunodeficiency diseases, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result.
Alcohol Use and Sexual Risk: An Intervention

Adolescents are at great risk for sexually transmitted diseases (STDs) including the human immunodeficiency virus (HIV) (CDC, 2000a; DiLorenzo \& Whaley, 1999). Though the CDC (2000b) reports that overall AIDS incidence is on the decline, there has been no comparable decline in the number of newly diagnosed HIV cases among young people aged 13-19, and young people of color are particularly at risk. Compared to the general adolescent population, adolescents involved with the criminal justice system are younger at first intercourse, have a greater number of sex partners, and lower rates of condom use, resulting in higher rates of unintended pregnancy and STDs (e.g., St. Lawrence et al., 1999). Alcohol use is commonly cited as a reason for lack of condom use among high-risk adolescents such as those involved in the criminal justice system (e.g., Morris et al., 1998) and recent data from our research suggests that it is heavy alcohol use in concert with sexual activity that is most strongly related to lack of condom use (Bryan, Rocheleau, \& Robbins, 2002a). The goal of this research is to design, implement, evaluation, and disseminate a successful HIV/STD risk reduction intervention that is theory-based, empirically targeted to adolescents, and articulated to a criminal justice setting. The study compares a sexual risk reduction intervention with a group motivational interviewing alcohol component to a standard sexual risk reduction intervention and a no treatment control condition. The investigators hope to show that: 1) A three-hour one-time intervention has the capacity to reduce sexual risk behavior up to one year post-release among high risk adolescents in detention, 2) A combined sexual and alcohol risk reduction intervention will result in larger decreases in sexual risk behavior than a sexual risk reduction alone, 3) The interventions will exert their effects through changes in mediators derived from a theoretically-based model of condom use intentions and behaviors, and 4) A sexual risk reduction intervention including an alcohol component will be especially effective for those adolescents with higher levels of existing alcohol problems. Finally, given proven efficacy, the intervention curricula and materials will be disseminated for use in adolescent detention facilities throughout the state.


Eligibility Criteria:
Inclusion Criteria:

* All young people between the ages of 14 and 17 who were in the detention centers at which recruitment took place.

Exclusion Criteria:

* Age less than 14 or non-English speaking
Group CBT for PPD in the Public Health Setting

Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have profound effects on mothers, their children, and their families. The cost of one case of PPD exceeds $150,000, a significant proportion of which is related to its impact on offspring. However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer than 15% of women receiving care. While Public Health Units have played an important role in PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group format is effective for treating depression in the perinatal period, and as PHNs are often the first point of contact for women experiencing PPD, with specialized training it is likely that they can deliver high-quality CBT.

The primary objective of this study is to determine if PHNs can be trained to deliver group Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence, improve mother-infant attachment and parenting and optimize infant emotional functioning.

In addition to its effects on maternal health, PPD can adversely affect mother-infant attachment, parenting, and the development and health of her children. The negative effects of PPD on offspring can include an increased risk of insecure attachment, poorer cognitive, language, and behavioral development, as well as an increased risk of emotion regulatory problems. To determine if PHNs can effectively deliver group CBT for PPD that is superior to postnatal care as usual, the investigators will proceed with a randomized controlled trial (RCT). Women in the treatment group will attend a 9-week group CBT intervention delivered by trained PHNs. Those in the control group will receive standard postnatal care.

This RCT will compare the effects of group CBT to postnatal care as usual on maternal depression, anxiety, mother-infant attachment, parenting, healthcare utilization and social support, as well as infant development, emotion regulation, and healthcare utilization

Eligibility Criteria:
Inclusion Criteria:

* Eligible women will be \>18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between 10 and 23. They will also all be within 12 months of delivering an infant

Exclusion Criteria:

* Women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.
Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings

In this study, the effect of nurse-led empowerment training given to patients with Type 2 Diabetes on clinical findings and empowerment behaviors will be investigated.

The research is a randomized controlled design research that includes a pre-test/post-test design. The primary outcome expected in the research; change in empowerment behaviors as a result of the training given; secondary outcomes are changes in clinical findings.

The research universe; All Type 2 diabetes patients who applied to the endocrinology polyclinic of a private hospital in Eskisehir city center between March-July 2019 consisted of. In the study, the sample was randomly selected, and it was aimed to reach all patients with Type 2 diabetes who were 18 years of age and older, with a diagnosis period of one year or more.

In the study, patients were randomly assigned to the intervention group, which included 6 weeks of training, or to the control group, which was on a 6-week waiting list. It used a question-based format to address the educational, behavioral, and psychosocial needs of patients within the scope of a 12-hour empowerment program that lasted for 6 weeks, 2 hours a week.

Education (DSMS (Developing Empowerment-Based Diabetes Self-Management Support)) is planned as stated literature.

Purpose of education: Empowerment as a philosophy of care emphasizes a collaborative approach to facilitating behavior change for patients themselves. Empowerment approach; Goal setting is a five-step process that provides patients with the knowledge and clarity they need to develop and achieve their diabetes and lifestyle goals. The first two steps are to identify the problem and identify patients' beliefs, thoughts, and feelings that may support or hinder their efforts. The third step is to determine the long-term goals expected from patients. In this step, patients are then expected to make a behavioral change that will help them achieve their long-term goals. The last step is for patients to evaluate their efforts and determine what they have learned in the process. Empowerment training was determined within the framework of this process.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus diagnosed more than 1 year ago

Exclusion Criteria:

* Mental retardation
* Dementia
* Deafness
* Blindness
* Psychiatric illness
* Steroid use
Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients ≥18 years of age.
* Patients with a diagnosis of Stage II hypertension, defined as mean sitting Systolic Blood Pressure (msSBP) ≥ 160 mmHg and \< 180 mmHg at Visit 2.

Exclusion Criteria:

* Severe hypertension defined as msSBP ≥ 180 mmHg and/or mean sitting Diastolic Blood Pressure (msDBP) ≥ 110 mmHg.
* Secondary form of hypertension.
* Current diagnosis of heart failure (New York Heart Association \[NYHA\] Class II-IV).
* Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
* Second or third degree heart block without a pacemaker.
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1.
* Clinically significant valvular heart disease.
* Previous history of hypertensive encephalopathy or stroke, Transcient Ischemic Attack (TIA), heart attack, coronary bypass surgery or any PCI.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* In the month prior to Visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications.
* Patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
* Inability to discontinue prior antihypertensive or other CV medications as required by the protocol.
* Patients with Type 1 diabetes mellitus.
* Patients with Type 2 diabetes mellitus not well controlled .
* Elevated Serum potassium (over 5.3 mEq/L (mmol/L).
* Any surgical or medical condition or the use of any medication which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.

Other protocol-defined inclusion/exclusion criteria may apply.
An Open-label, Intermediate Size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine

The purpose of this protocol is to allow subjects who completed any BHV3000 (rimegepant) clinical study to continue to have access to rimegepant while collecting ongoing safety data.

(NOTE: ONLY FOR PATIENTS who participated in a previous BHV-3000/Rimegepant Clinical Trial in the past)


Eligibility Criteria:
Inclusion Criteria:

1.Subjects who have completed any BHV3000 (rimegepant) clinical study without significant protocol violations.

Exclusion Criteria:

1. History of basilar migraine or hemiplegic migraine
2. History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease
3. HIV history
4. Uncontrolled hypertension or uncontrolled diabetes
5. Current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
6. History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to determine the safety and tolerability of single doses of QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to moderate COPD.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female patients with mild to moderate stable COPD, diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; 40-75 years of age
* Prebronchodilator baseline forced expiratory volume in 1 second (FEV1) 30-80% of the Quanjer predicted normal value (Quanjer et al. 1993) and at least 0.75 L with FEV1/forced vital capacity (FVC) \< 70% of predicted \[GOLD guidelines\].
* Previous smokers (\>10 pack-years). Ten pack years are defined as: 20 cigarettes a day for 10 years; 10 cigarettes a day for 20 years; or 40 cigarettes a day for 5 years. Current smokers, with \>10 pack year history, can be included under certain conditions.
* Vital signs (after 3 minutes resting measured in the supine position) which are within the following ranges:

  * oral body temperature between 35.0-37.5 °C;
  * systolic blood pressure, 100-170 mm Hg;
  * diastolic blood pressure, 50-100 mm Hg;
  * pulse rate, 50 - 90 beats per minute (bpm).
* Patients must weigh a minimum of 50 kg to participate in this study.
* Able to provide written informed consent prior to study participation.
* Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

* Pregnant women or nursing mothers.
* Patients with a QTc interval above 0.43 seconds for males and 0.45 seconds for females at the screening visit. If pre-treatment values on Day 1 of the treatment periods exceed 0.45 and 0.47 seconds for males and females respectively the visit may be re-scheduled once.
* Patients with a history of prolonged QTc intervals, or a family history of prolonged QT syndrome.
* Predominant diagnosis of asthma. (Patients must present without evidence of active asthma.)
* Patients who have been hospitalized or had emergency treatment for acute COPD exacerbation in the one month prior to or during screening.
* Patients who have had a respiratory tract infection within one month prior to screening.
* Patients with concomitant pulmonary disease, including a history of cancer

Other exclusion criteria apply.
Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia

Stroke-associated pneumonia (SAP) is the major complication of acute intracerebral haemorrhage (AICH), leads to poor clinical outcomes and increases the financial burden on the medical system. Prophylactic antibiotics do not reduce the mortality rate of SAP. The Tong-Fu-Xing-Shen herbal formula (TFXS) was shown to be effective for the prevention and treatment SAP in a previous clinical trial. To clarify whether TFXS is effective and safe for the treatment of SAP and affects the immunological mechanism of the "brain-gut-lung" pathway of SAP, the investigators designed this study.

This is a multicentre, randomized, double-blind, placebo-controlled clinical trial. A total of 218 patients will be recruited and randomly assigned to the experimental group (EG) or the control group (CG) in a 1:1 ratio. The treatment course will be 10-12 consecutive days, with a 90±7-day follow-up. The primary outcome is the all-cause mortality rate and the mortality of pneumonia at the 90±7-day follow-up. Secondary outcomes include changes in the gut microbiota; changes in the NIHSS score, BI index, mRS score, and Stroke-Specific Quality of Life scale (SS-QOL) score; and so on.

Eligibility Criteria:
Inclusion criteria

For inclusion, participants will need to fulfil all the following criteria:

1. A diagnosis of intracerebral haemorrhage according to 2019 Chinese guidelines for the diagnosis and treatment of acute intracerebral haemorrhage \[9\], with a CT scan of the brain confirming acute intracerebral haemorrhage;
2. Age between 18 and 85;
3. A diagnosis of SAP according to the modified CDC standard \[10\];
4. Within 7 days after stroke onset; and
5. Willingness to participate and to sign the informed consent form.

Exclusion criteria

Participants with any of the following conditions will be excluded:

1. Cerebral haemorrhage is confirmed by examination to be caused by a brain tumour, brain trauma, blood disease, cerebrovascular malformation (a congenital abnormality) or aneurysm;
2. Cerebral herniation;
3. A GCS score \<7;
4. Any antibiotic treatment within 4 weeks before the start of the study;
5. Pulmonary tuberculosis, pulmonary oedema, pulmonary embolism, noninfectious pulmonary oedema or respiratory circulation failure;
6. Liver or kidney function parameters (such as alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[Cre\]) 3 times higher than the upper limit of normal;
7. A clear history of gastrointestinal diseases, such as gastrointestinal tumours and inflammatory bowel disease, or a gastrointestinal bleeding period within 3 months;
8. Immune-related diseases, such as SLE, rheumatoid arthritis, and Sjogren's syndrome, or receiving immunotherapy for other diseases; and
9. Unsuitable for the trial as decided by the researchers.
Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)

The objective of this study was to evaluate the use of high frequency chest wall oscillation (HFCWO) early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD).

Acute asthma and chronic obstructive pulmonary disease (COPD) are exceedingly common, which together account for nearly 1 million hospitalizations each year in the United States alone. Beta agonists, anticholinergics, and corticosteroids delivered in aerosolized forms (via respiratory inhalers or nebulization) are recommended in the treatment of acute asthma and COPD. These medications rely on deposition into distal airspaces to suppress airway inflammation or promote bronchodilation. Unfortunately, excessive mucous production and impaired airway mucociliary clearance can lead to airway plugging, and thereby reduce the deposition of and response to aerosolized medications. These considerations highlight the need for therapies that clear airways of mucus in the acute management of asthma and COPD. High frequency chest wall oscillation (HFCWO) creates high velocity, low amplitude oscillatory airflows when applied through a pneumatic vest worn over the thorax, and is used for airway mucus clearance in patients with cystic fibrosis, bronchiectasis, and neuromuscular disorders.

This was a randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Admission to the inpatient medical service
* Physician-diagnosed asthma or asthma/COPD or COPD exacerbation.
* Evidence of airflow obstruction on spirometry

Exclusion Criteria:

* More than 24 hours since admission to the inpatient medical service
* Admission to an intensive care unit
* Hospital discharge planned within the next 24 hours
* Other chronic respiratory disease (e.g., sarcoidosis, idiopathic pulmonary fibrosis)
* Chest wall abnormalities (e.g., severe kyphoscoliosis) that precludes using the vest
* Chest wall or abdominal trauma/surgery in the past 6 weeks that precludes using the vest
* Physician declines to provide consent
* Patient unable (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
* Previous participant in this study
* Corticosteroid therapy (prednisone \>0 mg/d equivalent) for \>1 week prior to admission
Comprehensive Connected Cancer Care (C4): Intervention Evaluation

The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed or recurrent cancer who have not initiated treatment of any kind, including surgery, medical management, and/or radiation
* Patients with one reported social determinants of health (SDOH) need OR patients at high-risk for SDOH needs based on demographic information (racial \& ethnic minorities, medicaid/uninsured populations).
* Willingness to provide informed consent to participate

Exclusion Criteria:

* Not able to understand and communicate in English
* Unable and/or unwilling to access the internet on a phone, tablet, or computer