cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating MOA-728 Administered in Healthy Men

Absorption, distribution, metabolism, and excretion (ADME) study with 14C in healthy young men.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 to 50 years inclusive at screening.
* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI = weight (kg)/\[height (m)\]2
* Healthy as determined by the investigator on the basis of screening evaluations.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
Heart Failure Patients Registry

This study is a multicenter non-interventional observational prospective registry. This non-interventional study (NIS) does not imply any intervention into a routine clinical practice, including choice of treatment modality or special methods of investigation. The study will include only those patients who sign the informed consent form (ICF) after explanation of the study objectives and methods by the study physician.

Planned study population consists of 20 000 adult outpatients with HF. All patients with HF who signed an ICF will be included to this study. Planned number of study sites is 150 outpatient centers in about 50 regions (in order to describe characteristics of outpatients with HF in different regions in the most comprehensive way).

Expected inclusion period duration - 24 months OR reaching 20 000 patients, if this takes less than 24 months. Planned follow-up period duration for 1 patient is about 52 weeks (12 months), which includes 3 visits (visit 1 - inclusion; visit 2 - approximately 6 months after inclusion; visit 3 - approximately 12 months after inclusion)


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the time of inclusion;
2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
3. Documented diagnosis of HF (according to Clinical Guidelines "Chronic Heart Failure", 2020, approved by MoH of RF) with typical symptoms/signs of HF consistent with I-IV functional classes of HF according to NYHA classification.

Exclusion Criteria:

1. The absence of signed ICF;
2. The participation in any randomised controlled trial within 3 months before the inclusion in this study or during the participation in this study.
Trauma Informed Childhood Obesity Care for Low-Income Minorities in Primary Care

The purpose of this pilot study is to examine changes in childhood obesity associated with the implementation of a Trauma Informed Care approach with weight counseling and management among low-income minority children in a primary care setting.

Prospective mixed methods pilot study, using both qualitative and quantitative measures. This study will be conducted in two phases. In Phase 1 (Year 1), the investigators plan to use a modified Delphi procedure called the RAND/UCLA Appropriateness Method in which the investigators will form a multidisciplinary panel to develop a consensus of incorporating the TIC practices based on FOCUS into current best practices for childhood obesity prevention and treatment among low-income minorities to be facilitated by primary care providers. In Phase 2 (Year 2), the investigators will train and implement the Primary Care Provider-mediated FOCUS TIC-COM among providers for obese children and their caregivers / parents in the MLK OPC Family Medicine Clinic. During this phase, the investigators plan to examine the feasibility and acceptability of delivering the FOCUS TIC-COM in the primary care setting at MLKOPC through surveys and focus groups with both providers and the parents / caregivers of overweight / obese children. The investigators will also explore whether the FOCUS TIC-COM impact on childhood obesity (as perceived by child's parent / caregiver) and increase linkages to behavioral health care regarding trauma / toxic stress. At 3 month intervals, the investigators will train a subset of providers in the intervention and they will implement the intervention immediately after training.

Eligibility Criteria:
Year 1:

Inclusion Criteria:

• Adult Experts (\>18 years old) in the fields of trauma informed care and childhood obesity among low-income minorities

Exclusion Criteria:

• Individuals outside of the fields of trauma informed care or childhood obesity

Year 2:

Inclusion Criteria:

* Parents / Caregivers of overweight/obese children (ages 2-17 years old) in MLK-OPC who speak English or Spanish
* Primary Care Providers (\>18 years old) who work in the Family Medicine Clinic of the MLK-OPC

Exclusion Criteria:

* Parents / Caregivers of children that are not overweight/obese and/or under 2 years old
* Parent or caregiver that speaks a language other than English or Spanish
* Primary Care Providers who do not work in the Family Medicine Clinic of the MLK-OPC
Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects

To observe the pharmacokinetic profiles of benapenem and its major metabolites in healthy volunteers after continuous multiple-dose benapenem, providing evidence for phase Ⅱ/Ⅲclinical study.


Eligibility Criteria:
Inclusion Criteria:

* 1、 Male or female healthy subjects, aged 18\~45(including 18 and 45 years); 2、Body weight ≥ 50 kg and body mass index 19.0\~24.0 kg/m2; 3、Prior to the test, physical examination, blood routine, urine routine, liver and kidney functions, and related examinations normal, or mild abnormalities in indicators while without clinical significance as indicated by the investigator ; 4、Normal or mild abnormalities without clinical significance in the standard 12-lead ECG; 5、 Signing informed consent form.

Exclusion Criteria:

* 1、Having a serious systemic disease, infectious disease or mental disorder; 2、Regular smoking, alcohol abuse, and drug abuse ; 3、Use of drugs known damage to an organ within three months; 4、History of specific allergies, or history of drug allergy, especially those allergic to lactams and excipients of test drug; 5、Febrile illnesses within three days before the screening; 6、Patients with mental illness or psychotic disorder in the past; 7、Past mental and nervous system diseases (epilepsy, stroke, cerebrovascular disorder, etc.), gastrointestinal disorder (such as stomach ulcers, gastritis, etc.) or disorder of other systems (such as cardiovascular, respiratory, hematological, or endocrine system, etc.) diseases or medical history; 8、Habitually taking any medication, including traditional Chinese medicine; 9、Having taken any medication that may affect test results within two weeks before the screening, such as antibiotics, NSAIDs, aluminum- or magnesium-containing antacids, diuretics, anticoagulants, central nervous system depressants, and any drug that may affect the drug absorption; 10、Having participated in other investigational drug trial in the preceding three months; 11、Blood donation for 360 ml or more within three months before the screening; 12、Heart rate \< 50 bpm or \> 100 bpm; 13、Systolic blood pressure\<90mmHg or ≥ 140mmHg, diastolic blood pressure ≥ 90 mmHg or \<60mmHg ; 14、Women who are pregnant or breastfeeding, or who may be pregnant without adopting acceptable contraception, or who have a positive result in serum pregnancy test; 15、Women who are planning to become pregnant within 6 months, or male subjects who are planning to make his spouse pregnant within 6 months; 16、HBsAg, HCV antibody, HIV antibody, and Treponema pallidum antibody positive; 17、Urine drug-of-abuse testing positive; 18、Any other factor that makes the subject not suitable for the trial as indicated by the investigator.
Evaluating a Mental Health Digital Intervention for Dads

Approximately one in 10 fathers experience mental health difficulties during their partner's pregnancy and/or the postpartum period. There is a need for routine depression screening and timely interventions for fathers in the postpartum however there is a lack of resources tailored to men. To fill this gap, the investigators developed HealthyDads which includes up-to-date information and strategies related to i) prevention or reduction of stress and depressive symptoms; ii) parenting skills preparation tailored to expectant dads and iii) healthy lifestyle promotion for men at risk for depression. The investigators objective is to evaluate the acceptability of the HealthDads website targeting the mental health of at risk expectant fathers.


Eligibility Criteria:
Inclusion Criteria:

Fathers-to-be who:

* reside in Canada
* able to communicate in French or English
* gestational age of partner's pregnancy between 14-28 weeks
* internet access
* score \<12 on the EPDS
* at least 1 risk factor for depression if they score \<6 on the EPDS: a) history of depression; b) elevated anxiety (score \>10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale)116; or c) couple discord (established cutoff score \<13 on the 4-item Dyadic Adjustment Scale117 or Pittsburgh Sleep Quality Index global score \>5

Exclusion Criteria:

* suicidal ideation or intent
* score ≥12 on the EPDS
* having a severe psychiatric disorder as reported by the participant
An Extension Study of LON002 in Patients With Cancer

The purpose of this clinical trial is to evaluate the long term safety and efficacy of LON002.

This is an extension study of LON002 in patients with cancer, who have completed other London Pharma sponsored LON002 studies (parent study). It provides the opportunity for patients to continue receiving treatment for as long as the patient continues to derive a clinical benefit.

Long term safety and efficacy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent;
2. Has completed a LondonPharma sponsored parent trial of LON002 and continues to have clinical benefit in the judgement of the investigator;
3. Eligible for continuation of LON002 treatment at the end of the parent trial, according to the parent trial protocol;
4. Able to comply with the protocol LON002-003;
5. Women of child bearing potential must have a negative pregnancy test before the start of treatment;
6. Sexually active women of childbearing potential must be using an acceptable form of contraception for the duration of dosing and for 30 days thereafter;
7. Male subjects with female partners of childbearing potential should use condoms for the duration of dosing and for 30 days thereafter

Exclusion Criteria:

1. Has not completed a LondonPharma sponsored parent trial of LON002;
2. Unequivocal evidence of disease progression;
3. Unacceptable toxicity experienced in the parent trial;
Preventing Diabetes

The purpose of this project is to improve the quality of weight management care for patients with pre-diabetes and overweight or obesity. Personalized risk profiles, clinical decision support, and patient-centered decision tools for understanding pre-diabetes risk and the likelihood of preventing diabetes with a modest 5-7% weight loss will be developed. This project will offer patients their choice of effective weight management treatment options, each containing the cornerstone of weight management- intensive lifestyle intervention. Patients and PCPs will be better informed and equipped with information that helps them make weight management treatment decisions that work the best for their lifestyle, and each is expected to produce at least 5-7% weight loss over 6 months.

The primary aim of this study was to demonstrate that an increased recruitment rate for weight loss intervention can be achieved within patients that have pre-diabetes by communicating personalized risk of progression to type 2 diabetes, by estimating risk reduction with weight loss, and by offering program choice. Secondary aims included program participation rate, weight loss, and short term decreased diabetes risk.

Eligibility Criteria:
Inclusion Criteria:

* At least two weight measures within the last two 24 months, including most recent, that meet the following criteria:
* Prediabetes and BMI \>27: Treatment Option 1, 2, 3, or 4
* Prediabetes and BMI \>40: Treatment Options 1-5
* Most recent laboratory value that meets prediabetes indicators, per American Diabetes Association, 2016
* Hemoglobin A1C ≥5.7% and \<6.5%, or
* Fasting plasma glucose ≥100 mg/dl and \<126 mg/dl, or
* Oral glucose tolerance test ≥140 mg/dl and \<200 mg/dl

Exclusion Criteria:

* History of significant weight loss documented within 5 years,
* Contraindications to weight change (e.g., cancer, pregnancy)
* Prior bariatric surgery
* Weight loss medication use or orders within 5 years prior to the project.
Complementary and Alternative Medical Trends: A Patient Survey in a University Based Clinic

Patient survey identifying key elements of patient experience and decision-making processes regarding attendance University of California, Irvine (UCI)'s Integrative Medicine Clinic.

Patient survey to determine why patients come to UCI's integrative medicine clinic, whether they would prefer we accept insurance coverage, and what therapies they are using.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 41 years of age or older
* English speaking
* Ability to provide informed consent
* Patient at Gottschalk Medical Plaza Integrative Medical Clinic
* Ability to complete survey

Exclusion Criteria:

* Patient less than 41 years of age
* Inability to speak English
* Patient unable to provide informed consent
* Patient not being seen at Gottschalk medical Plaza Integrative Medical Clinic
* Incomplete survey
Pharmacokinetics of Progesterone in Pregnancy-2

The objective of this study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.

The objective of this pilot study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18yo
* Singleton gestation, ≥36 0/7 weeks gestation
* Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate

Exclusion Criteria:

* Contraindication to vaginal progesterone suppository

  * Active hepatic disease
  * Prior or current thrombus
  * Known adverse reaction to progesterone
  * Peanut allergy
* Bleeding disorder (such as thrombophilia)
* Use of 17-hydroxyprogesterone caproate in the pregnancy
* Use of vaginal progesterone in the pregnancy
* History of adverse reaction to progesterone
* Current vaginitis
Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome

In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.

Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.

Eligibility Criteria:
Inclusion Criteria:

* fulfillment of the Rome II criteria for IBS,
* availability of at least one colonoscopy within the last three years,
* aged 18 or older at the time of screening,
* provision of written informed consent,
* commitment of availability throughout the 12 week study period.

Exclusion Criteria:

* major abdominal surgery in the past other than other than appendectomy, caesarean section, tubal laparoscopic cholecystectomy, abdominal wall hernia repair or/and hysterectomy,
* current use of antibiotics,
* history of organic intestinal disease,
* pregnant or breastfeeding mothers,
* chronic infectious disease like HIV or tuberculosis, and
* unable to understand English or Afrikaans.
Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.


Eligibility Criteria:
Inclusion Criteria:

Type of Subject and Disease Characteristics

1. Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study end-of-treatment (EOT) visit.
2. Treatment with standard of care PAH disease-specific background therapies (stable dose).

   Informed Consent
3. Review and signature of an IRB-approved informed consent form.

Exclusion Criteria:

Medical Conditions

1. Persistent and clinically significant systemic hypertension or hypotension.
2. Interval history of newly developed left-sided heart disease.
3. Potentially life-threatening cardiac arrhythmia with an ongoing risk.
4. Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
5. Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or GB002 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
6. History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.
7. Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose.
8. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
9. Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine \[PCP\]).
10. Have any other condition or reason that, in the opinion of the Investigator and/or the Sponsor's Medical Monitor (or designee), would prohibit the subject from participating in the study.

    Diagnostic Assessments
11. Chronic renal insufficiency
12. Hemoglobin (Hgb) concentration \<8.5 g/dL.
13. Absolute neutrophil count (ANC) \< 1x 10\^9/L.
14. Platelet count \<50 x 10\^9/L.

    Prior Therapy
15. Use of inhaled prostanoids.
16. Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant \[NOAC\]/direct oral anticoagulant \[DOAC\]).
17. Chronic use of any prohibited medication.

NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

After a traumatic event such as an accident or an assault, victims may experience intense stress symptoms that may evolve into "post-traumatic stress disorder" (PTSD). It is a frequent and serious pathology, which can be complicated by depression, addiction or suicide. Few means are available to prevent PTSD in people who have just undergone trauma. Prazosin is an antihypertensive drug that blocks α1 adrenaline receptors which could help to stop the vicious circle of stress and prevent the development of the disease. The objective of this study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who visit an emergency department after trauma.


Eligibility Criteria:
Inclusion Criteria:

* Patient of age \>18 years and \<65 years
* Victim of direct experience trauma (accident or physical aggression)
* Presence of an ASD between D3 and D7 after the trauma according to DSM V criteria

Exclusion Criteria:

* Contra-indication to prazosin: orthostatic hypotension, right heart failure, other hypotensive therapy, 5-phosphodiesterase inhibitors (sildenafil) or diuretic, history of syncope or severe unexplained faintness, hypersensitivity known to quinazolines.
* Alcohol and / or drug use at the time of the trauma
* History of psychotic disorder
* Suicidal risk defined by a score ≥ 2 on the Suicidal Ideas Item of the Beck Depression Inventory (BDI)
* Protected or vulnerable Major
* Persistence of a life threatening injury at D3
* Sexual assault
* Only moderate head trauma can be included and therefore excluded patients with loss of consciousness greater than 30 minutes, Glasgow score less than 13, post-traumatic amnesia greater than 24 hours (Ruff et al., 2009) .
* Prescription of morphine or morphine derivative in progress
* Pregnancy or breastfeeding period
* Lack of effective contraception in a woman susceptible to childbearing
* Known hepatic dysfunction
* Narcolepsy (Gelineau's disease)
* Cardiac or vascular history including coronary artery disease
* Strict low-sodium diet
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer

Vibrent Health is partnering with Stanford Cancer Center to conduct a randomized control trial (RCT) using mobile health technology to enhance adherence and improve swallowing outcomes in patients undergoing radiation therapy for head and neck cancer.

Head and neck cancer (HNC) is the 6th most common type of cancer in the world and has recently seen a dramatic rise in the United States due to a rise in the incidence of oropharyngeal cancers related to the human papillomavirus (HPV) . The majority of patients diagnosed with HNC receive radiation therapy at some point in their treatment, either in the definitive or post-operative setting. Dysphagia is a common consequence of treatment for HNC, experienced by approximately 50% of patients treated with radiation therapy. Post-treatment dysphagia has been associated with increased risk of morbidity/mortality as well as well-recognized deterioration of quality of life. Performance of swallowing exercises during radiation significantly reduces dysphagia risk; however, patient adherence to swallowing exercises during radiation treatment is limited. Thus, poor adherence stands as a major obstacle to achieving the best swallowing outcomes. In response to this, a mobile health application was developed to directly address barriers cited by patients as reasons for non-adherence. The objective is to conduct a randomized controlled trial to test the impact of the mobile application on adherence to prophylactic swallowing therapy during radiation for HNC.

Eligibility Criteria:
Inclusion Criteria:

* Study subjects ≥ 18 years of age.
* Fluent English speaking subjects.
* Study subjects capable of providing informed consent.
* Patients with newly diagnosed non-metastatic head and neck cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx, and larynx that require bilateral neck radiation. Individuals with unknown primary head and neck cancer with nodal disease necessitating bilateral radiation will also be included.
* Study subjects with a previously untreated head and neck cancer diagnosis requiring a definitive course of radiotherapy requiring a prescribed dose of 60Gy or greater.
* Study subjects who have either an Android or Apple iOS-based smartphone or tablet compatible with the Vibrent application.
* Study subjects who have access to a sufficient monthly data plan (approximately 200 MB/month), or Internet connection.

Exclusion Criteria:

* Non-English speaking, or incapable of providing informed consent.
* Lack of smartphone, tablet, or Internet connection.
* Inability to use the Vibrent application.
* Patients being treated for head and neck cancer who do not receive some form of primary, adjuvant, or neo-adjuvant radiation therapy will not be considered for the study.
* Patients with recurrent disease.
* Pregnant women.
* Individuals under the age of 18.
* Individuals with contraindications to radiation therapy.