cyrilzakka/clinical-trials huggingface dataset:
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)

This is a randomised, double-blind, 3-part study designed to investigate the safety and tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single administration, and following multiple administrations of ATM-AVI in healthy male and female (females of nonchildbearing potential) volunteers both young and elderly.

A Phase I, Randomised, Double-blind, 3-Part Study in Healthy Young and Elderly Subjects to Assess the Safety and Tolerability, and Investigate the Pharmacokinetics of Aztreonam and Avibactam given Alone and in Combination (ATM-AVI)

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy young male and female volunteers aged 18 to 45 years (inclusive) and healthy elderly volunteers aged 65 or older (Part C) with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 19 and 30 kg/m2
* Be able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the PI

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
* History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Known history of severe allergy to betalactam and/or L-arginine
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to ATM or AVI
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the first administration of IP
Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

The goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. In addition, it is also our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance.

It is our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance. Data from our two research teams suggest that the cardiac and skeletal muscle microvascular dysfunction present in people with type 2 diabetes contributes to limitations in cardiac and skeletal muscle function associated with impaired functional exercise capacity (a major predictor of CV and all-cause mortality). Insulin action is a potent predictor of the functional exercise capacity impairment in type 2 diabetes. The exact relationship between insulin action, cardiac and muscle dysfunction, cardiac and skeletal muscle perfusion and decreased functional exercise capacity in type 2 diabetes remains unclear.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary (defined as less than 1 hour per week of physical activity)
* BMI: 25-40
* Men and women with and without type 2 diabetes

Exclusion Criteria:

* Documented cardiovascular disease
* Uncontrolled hypertension: disease systolic blood pressure (SBP) \> 150, diastolic blood pressure (DBP)\> 110
* Obstructive pulmonary disease or asthma
* Peripheral neuropathy
* Physical impairment that would limit exercise ability
* Subjects taking beta blockers, calcium channel blockers, insulin, or Thiazolidinediones (TZD)
* Current or past smoking within the last 1 years
* Current tobacco use
* Anemia
* Control HbA1c \> 5.7, T2DM HbA1c \> 9
* Pregnant, nursing or hormonal therapy (other than contraceptives)
* Peri or post-menopausal women
* Type 1 diabetes
* Hepatic or renal disease.
The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers

Participants will complete a phone screen and then one laboratory session. After completing in-person screening assessments, eligible participants will complete additional questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the session. Participants will then sample two e-liquids that vary in nicotine content from little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the subjective effects of each one. Participants will then complete a preference assessment where they choose between the two e-liquids. Participants will be blind to the nicotine contents.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Daily cigarette smoking
* Have tried vaping devices on a minimum of one lifetime occasion

Exclusion Criteria:

* Unwilling to use a vaping device during the session
* Break alcohol level \> 0.01 (g/dL)
* Pregnant, trying to become pregnant, or breastfeeding
* Systolic BP greater than or equal to 160 mm/Hg or below 90 mm/Hg
* Diastolic BP greater than or equal to 100 mm/Hg or below 50 mm/Hg
* Heart rate greater than or equal to 105 bpm or lower than 45 bpm
* A current upper respiratory infection, recent cardiac event (in the last year), Buerger disease, irregular heartbeat or arrhythmia within the last year, previous allergic or adverse reaction to nicotine
Glottic Width and Respiratory Flow in Patients With Various Lung Diseases

In this study the investigators examine the glottic width and the respiratory flow at rest in patients with various lung disease. The investigators postulated that a positive expiratory pressure is created through the narrowing of the glottic width in patients with hyperinflation.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for a bronchoscopy
* Minimum age of 18 years
* Signed informed consent

Exclusion Criteria:

* Patients requiring mechanical ventilation during bronchoscopy
* Disease of the larynx
* Inability to breathe through the mouthpiece
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.


Eligibility Criteria:
Inclusion Criteria:

* Women 15 to 50 years of age.
* Currently or recently pregnant.
* Consent to participate.
* Authorization for her health care provider(s) (HCP\[s\]) to provide data to the registry.
* Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy.
* Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed.

Exclusion Criteria:

* Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
* Exposure to known tetratogens and/or investigational medications during pregnancy.
* Lost to follow-up.
Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women

The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.


Eligibility Criteria:
Inclusion Criteria:

* Having received ellaOne® as emergency contraception at the clinical site
* Postmenarcheal adolescents or adult women
* Willing to provide information on bleeding, sexual intercourses, method of contraception, concomitant medications and adverse events for the next two menstrual periods and to complete the diary accordingly
* Willing to provide information on pregnancy outcome / delivery and newborn's health at delivery
* Able to provide written informed consent
* Willing to not participate in a clinical trial before the end of study participation

Exclusion Criteria:

* Currently participating in any interventional clinical trial (testing an Investigational Medicinal Product)
Exercise in Men With Prostate Cancer

The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.


Eligibility Criteria:
Inclusion Criteria:

* men aged 50 years or older
* diagnosed with adenocarcinoma prostate cancer
* will initiate and receive continuous ADT (luteinizing hormone releasing hormone agonist (LHRH) or combination of LHRH and anti-androgen) for at least 12 months after recruitment
* Patients will also consent to participating in the study.

Exclusion Criteria:

* severe cardiac disease (New York Heart Association class III or greater)
* angina
* severe osteoporosis
* uncontrolled hypertension (blood pressure \> 160/95mm Hg)
* orthostatic blood pressure drop \> 20mm Hg
* moderate to severe aortic stenosis
* acute illness or fever
* uncontrolled atrial or ventricular dysrhythmias
* uncontrolled sinus tachycardia (\> 120 beats per minute)
* uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (\> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness, severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, pathological lower limb fractures within 6 months, lower limb amputation).
Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease

Although DBS improves patient's quality of life advanced Parkinson's patients (PD) by addressing the cardinal symptoms and reducing levodopa motor complications, symptoms still worsen over time. Postural problems, frequent falls, freezing of gait impairment and other locomotion difficulties still remain as important causes of disability and incapacity. Novel therapeutics approaches are needed to restore quality of life (QoL).

This study aims to explore the effects of spinal cord stimulation in locomotion, falls and freezing of gait in advanced PD patients.

Twenty PD patients will undergo thoracic spinal cord stimulation at high frequencies in a prospective study for six months.

Changes in locomotion capacity and freezing of gait rating will be the primary out come. Secondary outcomes will be: QoL and common motor outcome measures in PD patients. Always comparing the status before, one, three and six months after stimulation was initiated. A double blind trial will be performed within three months of follow up (high X low frequency stimulation).

Background: Currently there are no available Parkinson's disease (PD) therapy can really stop disease progression. Although Deep Brain Stimulation (DBS) improves patient's quality of life by addressing the cardinal symptoms and reducing Levodopa motor complications, non motor symptoms still increasing over time. Gait problems as falls and freezing are important cause of disability and incapacity. Novel therapeutics approaches are needed to restore quality of life. Data from animal PD model suggest that spinal cord stimulation (SCS) can enhance locomotion in mice. Although clinical results, mostly from case reports, in PD patients are still conflicting, a few patients benefited from SCS in thoracic levels.

Aim: Evaluated Spinal cord stimulation effects in locomotion, gait, freezing and falls in PD patient's.

Method: 20 PD patients will undergo thoracic spinal cord stimulation with high frequency in a prospective study for six months. Gait and freezing evaluation will consists in: timed up and go test, timed up and go test with dual task, 20 m walk test, 20 m walk test with obstacle, freezing of gait scale and falls scale. PDQ 39 and Schwab and England scales will be used to measure quality of life. Unified Parkinson's Disease Rating Scale for motor symptoms and general evaluation. All tests will be done before surgery, after one week, one, three, six months. All patients will be stimulated with the same parameters: High frequencies and 90 mcs pulse width and the sensory threshold will be measured. At the third month the parameters of SCS will be changed and comparative tested for low frequency in a double blind trail.

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic PD
2. Gait and locomotion problems as the main complain/symptom
3. PD patients with or without DBS
4. Hoehn and Yahr scale equal or more than 2.0

Exclusion Criteria:

1. Dementia
2. Hoehn and Yahr scale more than 4
3. Less than 5 years of Parkinson's disease symptoms
4. General contraindications of surgery
Mifepristone Outpatient Labour Induction

The number of women having an induction of labour is increasing and is currently used in 33% of pregnancies for a range of medical reasons. The majority of women are admitted to hospital to have their labour induced, using methods which are protracted and associated with a poor birth experience, making them both costly and unpopular. Further, current methods of outpatient induction are unsuitable, unsafe and/or have a poor acceptability. The COVID-19 pandemic has driven a reduction in the number of face-to-face interactions taking place across all areas of medicine. Proving the efficacy and safety of Mifepristone would significantly reduce pre-labour admission rates and hospital length of stay for pregnant women, who are at particularly higher risk of COVID-19, and reduce delivery costs.

The study is a double blinded, two arms, multi-centre randomised controlled clinical trial to investigate the clinical effectiveness, safety and resource utilisation of intervention for the induction of labour in women admitted to the hospital. Subjects will be randomised 1:1 to one of the two arms to receive:

Arm 1: Mifepristone + standard of care Arm 2: Placebo + standard of care

The study treatment will commence from the administration of the Mifepristone or placebo. The participants will be assessed 2 days after treatment regimen will be completed as an in-patient.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women between 38 and 41+5 weeks of gestation
2. Singleton pregnancy
3. Aged 18 years or older
4. Intact fetal membranes at the time of recruitment
5. Unfavourable cervix (Bishop Score \&lt;6)
6. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.

Exclusion Criteria:

1. Multiple pregnancy
2. Breech presentation
3. Early labour
4. Contraindication to vaginal birth (placenta praevia, transverse lie, known or suspected cephalo-pelvic disproportion or other factor contraindicated to vaginal birth in the opinion of the investigator)
5. Rupture of membranes
6. Parity \&gt;3
7. Clinical evidence of fetal growth restriction
8. Fetal macrosomia (\&gt;95th centile or absolute weight \&gt;4.5kg) based on ultrasound assessment
9. Presence of reduced fetal movements, abnormal CTG or recent antepartum haemorrhage
10. Medical conditions:

    i. anaemia \[\&lt;100g/l\] ii. liver disease iii. pre-existing diabetes\* iv. preeclampsia v. obstetric cholestasis vi. renal disease vii. cardiac disease viii. sexually transmitted infections ix. bleeding disorders, on anticoagulants, steroid or aspirin therapy x. prior uterine operations (Caesarean Section or myomectomy)
11. Contra-indications to mifepristone including chronic adrenal, hepatic, renal failure
12. Hypersensitivity to mifepristone or to any excipients, or malnutrition
13. Severe asthma uncontrolled by therapy and inherited porphyria
14. Any investigational drug within 30 days prior to the trial drug administration. \*NOTE: women with diet controlled gestational diabetes can be included in the trial
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)

The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.


Eligibility Criteria:
Inclusion Criteria:

* Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening
* Must have active OIC at screening
* Active OIC must be confirmed during baseline screening bowel habit and symptom diary
* Must be on stable diet

Exclusion Criteria:

* Has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction)
* Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative)
* Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years
* Unstable thyroid disease
Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement

The NHWD-870 Phase I clinical trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced tumors. The objectives of this retrospective study were to preliminarily evaluate the anti-tumor efficacy of NHWD-870 HCl in patients with advanced solid tumors or lymphomas and to preliminarily evaluate biomarkers associated with the efficacy of NHWD-870 HCl in the treatment of patients with advanced solid tumors or lymphomas, to provide a basis for identifying the enriched population for the late-stage trial.


Eligibility Criteria:
Inclusion Criteria:

1. Signing an informed consent form;
2. Patients with advanced solid tumors or lymphomas definitively diagnosed by pathology;
3. Age ≥18 and ≤75 years;
4. Eastern Cooperative Oncology Group (ECOG) score physical status score of 0 to 1;
5. Expected survival of \>3 months;
6. NUT positive confirmed by molecular testing.

Exclusion Criteria:

Subjects who meet one or more of the following criteria will be excluded:

1. Other serious complications (such as uncontrolled infection, myocardial infarction within 6 months, high blood pressure (≥ 160/100mmHg) and thromboembolic disease that cannot be controlled by drug intervention, etc.);
2. The adverse reactions of previous anti-tumor therapy have not been restored to CTCAE 5.0 ≤ Grade1 (except for hair loss, anemia and other toxicities judged by researchers to be unsafe);
3. History of substance abuse;
4. Inability to take drugs due to dysphagia (except for patients who receive nutrients through a gastric tube due to dysphagia), or conditions that the investigator determines seriously affect gastrointestinal absorption;
5. Patients with a history of other serious systemic diseases who are judged by the investigator to be unsuitable for participating in clinical trials;
6. Alcoholics or those who drink more than 28 units of alcohol per week (1 unit = 285 mL of beer or 25 mL of spirits or 1 glass of wine);
7. Suffering from uncontrollable mental illness;
8. Pregnant or lactating women, or patients of childbearing age (including male subjects) with pregnancy plans;
9. Active hepatitis B (viral titer \>103), hepatitis C or HIV ( );
10. Long-term treatment with high-dose corticosteroids or other immunosuppressants, such as those who have undergone organ transplantation, or those who have received systemic glucocorticoids (such as prednisone\> 10 mg/day or equivalent drugs) or other immunosuppressant therapy within 14 days before the first use of the study drug; Exceptions are given for topical, ocular, intra-articular, intranasal and inhaled corticosteroid therapy; short-term use of glucocorticoids for prophylaxis (e.g., prevention of contrast allergy);
11. The investigator believes that the subject is not suitable to participate in this clinical study for other objective reasons.
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

Pilot Study of patients across all wound classes for recurrence

Eligibility Criteria:
Inclusion Criteria:

* Subject or subject's legally authorized representative must be willing to give written informed consent
* Subject must be diagnosed with ventral or incisional hernia
* Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion Criteria:

* Subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery).
* Subject's hernia has recurred four or more times.
* Subject's body mass index (BMI) \>40 kg/m2.
* Subject has peritonitis.
* Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
* Chronic steroid use or immunosuppression drugs (\> 6 months).
* Subject has cirrhosis, and/or ascites.
* Subject is American Society of Anesthesiology Class 4 or 5.
* Subject is pregnant or planning to become pregnant during the course of the study.
* Subject is known to be infected with human immunodeficiency virus (HIV).
* Subject has a life expectancy of less than 2 years at the time of enrollment.
* Subject has been treated with an investigational product in the past 30 days.
* Subject is part of the site personnel directly involved with this study
* Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials.
* Subject has any condition that in the opinion of the Investigator would preclude the use of the study device, or preclude the subject from completing the follow-up requirements