cyrilzakka/clinical-trials huggingface dataset:
Study of an Extended Release (ER) Tablet, Single and Repeated Dosing

The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
* Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator

Exclusion Criteria:

* ECG findings outside normal range
* Potassium outside normal reference values
Cigarette Smoking in Smokers With and Without Schizophrenia

Higher rates and severity of tobacco dependence in people with schizophrenia, as compared with the general population, contribute to the lower life expectancy seen in this population. Dependent tobacco smoking is controlled by how different aspects of cigarette smoking are perceived. There is evidence suggesting that people with schizophrenia differ in how they perceive cigarette smoking, which, if confirmed, would have implications for tailoring treatment interventions for smoking cessation in schizophrenia.

The aim of the present study is to determine whether tobacco smoking in people with schizophrenia is governed by different aspects and effects of cigarette consumption. Smokers participating in this study either have no psychiatric diagnosis, or a diagnosis of schizophrenia or schizoaffective disorder. Over four study visits, participants will sample and compare different research cigarettes, complete questionnaires and concentration tasks, and smoke one type of research cigarette for eight hours while wearing a nicotine patch. By shaping our understanding of tobacco dependence in schizophrenia, the present project may redirect treatment development toward strategies tailored to the specific vulnerabilities of this population, which is among the most severely affected by its detrimental impact on health and life.

Eligibility Criteria:
Inclusion Criteria:

* Regular smoker of at least 10 cigarettes or cigarillos/day for at least 2 years
* For participants with schizophrenia: DSM-5 diagnosis of schizophrenia or schizoaffective disorder
* For participants with schizophrenia: Able to give informed consent
* For smokers with schizophrenia: No change in psychiatric medication or dosage in the last 4 weeks

Exclusion Criteria:

* Uncontrolled hypertension (resting systolic BP above 150 or diastolic above 95 mm Hg)
* Cardiovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, severe arrhythmias, or EKG abnormalities
* Severe asthma
* Chronic obstructive pulmonary disease
* Neurological illness, such as stroke, seizure disorder, neurodegenerative disease, or organic brain syndrome
* Mental retardation
* Alcohol or substance use disorder except nicotine within the last year
* Use of benztropine (Cogentin), varenicline (Chantix), bupropion (Wellbutrin, Zyban), or any type of nicotine replacement
* Pregnant or lactating
* For healthy control smokers: DSM-5 diagnosis of depression, bipolar disorder, ADHD, autism spectrum disorder, anorexia, bulimia nervosa, or any schizophrenia-spectrum disorder
* For healthy control smokers: immediate family history of psychosis
Swab Sample Collection for the Detection of Bacterial Proteases

The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of infection. Swab samples will be collected from acute and chronic wounds of different etiologies and these will be analysed for bacteria types and markers of infection.


Eligibility Criteria:
Inclusion Criteria:

* Subject has presented to participating study site with a wound(s) suspected to be infected, as determined by the Investigator and/ or study staff - defined as one that through clinical judgment has questionable infection status, and /or shows three or more of the NERDS or STONES signs of infection);
* Subject has presented to participating study site with a wound(s) suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show three or more of the NERDS or STONES signs of infection.
* Subject is 18 years of age or older.
* Subject agrees to complete all aspects of the study and provides Informed Consent

Exclusion Criteria:

* Subject is less than 18 years of age.
* Target wound contains a malignancy
* Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
* Subject is confirmed to be positive for HIV or hepatitis.
* Subject is unable or unwilling to provide informed consent.
* Subjects deemed inappropriate for the study by the site's Principal Investigator.
Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer

Post operative adjuvant chemotherapy followed by adjuvant Tamoxifen vs nil for patients with operable breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with operable breast cancer
Feasibility of Community Psychosocial Intervention for Women

The purpose of the current protocol is to describe a cluster randomized feasibility trial examining the integration of a scalable stress management intervention into Entre Nosotras ('among/between us'), a community-based psychosocial intervention for migrant and host community women in Ecuador and Panamá.

Specifically the study aims to:

1. Explore the relevance, acceptability, and feasibility of integrating a stress management intervention into community-based participatory women's group
2. Examine the feasibility of conducting a fully-powered cluster randomized controlled trial evaluating the effectiveness and implementation of integrating a stress management intervention into a community-based participatory women's group as compared to community-based participatory women's groups alone.

The proposed research directly targets two public health areas with major gaps in evidence in the field of humanitarian settings: (1) protection and safety, and (2) mental health and psychosocial wellbeing.

This research will be conducted in three sites in Ecuador and Panama. Latin America has recently experienced increasing levels of forced migration due to political conflict, community violence, and other factors. Panamá and Ecuador host refugees, asylum seekers, and migrants from a range of Central and South American countries (e.g., Colombia, Nicaragua, Venezuela). Migrants in these contexts face mental health and psychosocial problems, threats to their safety, and disrupted social support systems. Gaps in psychosocial services to address these problems despite their high prevalence persist in both countries and have been exacerbated due to the COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years) women residing in the study community who speak and understand Spanish
* Displaced or host community members

Exclusion Criteria:

* Severe psychological distress (Kessler-6 \>=13)
* Moderate or high risk of suicide
* Cognitive impairment
AT-007 in Adult Subjects With Classic Galactosemia (CG)

This study is a 12-month open-label extension (OLE) study of AT-007 in adult subjects with CG who previously participated in Study AT-007-1001 Part D and/or Part D Extension.

The study is designed to assess the long-term safety of AT-007 in subjects with CG as well as the pharmacodynamics (PD) (inhibition of galactitol) and PK of AT-007. The effect of 12-month treatment with AT-007 on the levels of galactose and other galactose metabolites in subjects with CG will also be evaluated.

Primary:

- To evaluate the long-term safety of 12-month oral administration of AT-007 in adult subjects with Classic Galactosemia (CG)

Secondary:

* To evaluate the long-term inhibition of galactitol, a biomarker of aldose reductase (AR) activity, induced by 12-month oral administration of AT-007 to adult subjects with CG
* To evaluate the pharmacokinetic (PK) parameters of 12-month oral administration of AT-007 in adult subjects with CG

Exploratory:

* To evaluate the effect of 12-month oral administration of AT-007 on the levels of galactose and its other metabolites in adult subjects with CG
* To evaluate the burden of illness (BOI) of adult subjects with CG
* To evaluate quality of life (QOL) measures of adult subjects with CG
* To evaluate the effect of 12-month oral administration of AT-007 on the BOI and QOL of adult subjects with CG

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female subject with a CG diagnosis
* Previous participation in Study AT-007-1001 Part D and/or Part D Extension
* No other significant health problems which preclude participation

Exclusion Criteria:

* Concomitant use of certain medications or over-the-counter therapies
* Discontinuation from Study AT-007-1001 Part D and/or Part D Extension due an adverse event
CareSuperb COVID-19 Antigen Test Usability

The purpose of this study is to evaluate the usability of the CareSuperb COVID-19 Antigen Home Test in Home Use.

COVID-19 is a contagious respiratory illness, caused by infection with the novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This communicable disease is easily transmitted through aerosolized droplets containing the infectious virus. Infections with SARS-CoV-2 can have varying degrees of signs and symptoms, ranging from asymptomatic to severe. Individuals infected with SARS-CoV-2 are believed to be contagious from as early as two days prior to symptom onset to at least ten days after the onset of symptoms. The rapid detection of infections and contacts and the implementation of infection control measures are critical for mitigation of this virus.

The CareSuperb COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult lay user-collected anterior nares swab samples from individuals aged 2 to 13 years.

Eligibility Criteria:
Inclusion criteria:

1. An Institutional Review Board (IRB) approved informed consent / assent, if applicable, is signed and dated prior to any study-related activities.
2. Male and female subjects 2 years of age and older.
3. Subject is willing to provide a self-collected nasal swab sample. (If the subject is under the age of 14, an adult lay-user will collect the sample.)
4. Subject agrees to complete all aspects of the study.

Exclusion criteria:

1. Subject has a visual impairment that cannot be restored with glasses or contact lenses.
2. Subject has prior medical or laboratory training.
3. Subject uses home diagnostics, e.g., glucose meters, HIV tests.
4. Subject has prior knowledge of their current COVID-19 infection status.
Ischemic Preconditioning at a Distance in Liver Surgery

During hepatic transection, it exists a high risk of perioperative blood loss. The haemorrhage and its consequences (hypovolemia and blood transfusion) might impact the short and long term morbidity The vascular control by hepatic pedicle clamping (Pringle's maneuver) or total hepatic vascular exclusion, helps minimizing blood loss and leads to a more extensive hepatic resection.

Side effects of vascular control result of ischemia-reperfusion injury (IRI) : these reperfusion lesions results of different mechanisms than those responsible for the ischemic one. IRI cause lesions and postoperative dysfunction of the remaining liver.

Among strategies to reduce the adverse effects of IRI : ischaemic preconditioning (IPC) has been described. It can be either mechanical (intermittent hepatic pedicle clamping) or pharmacological (sevoflurane inhalation).

Short intermittent vascular occlusions in a organ might produce a resistance to a longer ischaemic period. It is certainly a physiological organ adaptation to tissue hypoxemia, which has a therapeutic potential when targeted.

During liver resection, ischaemic preconditioning is realised with periods of hepatic pedicle clamping and unclamping. It decrease morbidity and mortality and prevent postoperative hepatocellular insufficiency due to clamping and IRI at day 5.

Ischaemic preconditioning may also be applied remotely. Indeed, it is shown that short ischaemic periods in a target organ can also have a protective effect on distant others. This mechanism involve three signalling pathways : neuronal , humoral and systemic pathways.

In a previous randomized study, Kanoria and al, demonstrated that the remote ischaemic preconditioning group has shown significant lower rates of serum transaminases and higher liver clearance (spectrophotometry method) than the control group.

A latest study, measuring postoperative prothrombin rates has shown improved liver recovery due to halogen agents such as sevoflurane.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled carcinogenic laparoscopy or laparotomy liver resection
* Insured under the social security system
* Inclined to comply to the study protocol and its duration.

Exclusion Criteria:

* Patient under guardianship
* Pregnancy or breastfeeding
* Severe lower limb vascular disease
* Emergency surgery
* Contraindication of a treatment from the protocol
* Psychological disorder with difficulty to accede the protocol
* Absence of written informed consent
* Refusal to sign the protocol
* Non-registration to the social security system
Olfactory Function Following Endoscopic Endonasal Skull Base Surgery

The purpose of this study is to compare a subject's sense of smell before and after endoscopic endonasal surgery to remove a skull base abnormality (i.e. tumor, inflammatory process, fracture, defect, etc.) and use the information collected to validate approaches to surgery that will minimize side effects to the sense of smell function. Data will be collected using a smell identification test along with two questionnaires. In addition, demographic, medical history, treatment, outcome, and follow-up information will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with skull base pathologies requiring endonasal surgery at The Ohio State University Wexner Medical Center
* 18 years or older
* Able to consent for self
* Negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

* Patient unable to return to clinic at specific follow-up times
* Pregnant or nursing
* Prisoners
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

To characterize the acute effects of oral Dronabinol (10 mg capsule) in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Eligibility Criteria:
Inclusion Criteria:

* At least one lifetime exposure to cannabis
* Good physical and mental health

Exclusion Criteria:

* Cannabis naive individuals
* Major current or recent stressors
* Taking estrogen supplements or oral contraceptive pills (for women)
* Sesame oil allergy
The Use of Barbed Sutures in Total Hip Arthroplasty

The purpose of this study is to evaluate the role of new barbed suture for closure of wound during total hip arthroplasty in reducing the risk for wound healing problems.


Eligibility Criteria:
Inclusion criteria:

* All patients receiving elective primary THA through the direct anterior approach, treated by the primary investigator (JP) at the Thomas Jefferson University Hospital or Rothman Specialty Hospital.

Exclusion Criteria:

* Prior surgical incision or scar in close proximity of the proposed incision (\<2 cm).
* Local skin conditions such as dermatitis, eczema, or psoriasis.
* Active or previous infection in the skin or the hip.
* Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical cortico-steroid use
Effectiveness of Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom

This is a 12-week, single-center, randomized, prospective, confirmatory study of effectiveness of the individualized automatic coaching messages for glycemic management based on continuous glucose monitoring and depressive symptom in insulin-treated patients with type 2 diabetes.

This study will enroll patients with type 2 diabetes who are insulin-treated outpatient care at the Department of Endocrinology and Metabolism, Samsung Medical Center. For 12 weeks, both intervention and control groups will apply continuous glucose monitoring system. The intervention group will receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depressive symptoms based on depression questionnaires. The control group will not receive the coaching messages. The aim of this study is to evaluate whether the efficacy of individualized automatic target coaching messages based on continuous glucose monitoring metrics and depressive symptom assessments is superior to those who do not receive the messages in insulin-treated patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Patients for whom the use of a continuous glucose monitor has been determined based on the medical judgment of the attending physician.
* Insulin-treated type 2 diabetes patients, age 18-80 years old.
* Patients who have not changed their diabetes medication in the past 2 months.
* Patients with a glycated hemoglobin level between 6.5% and 12.0% within the last 3 months.
* Patients currently receiving insulin injection therapy, including basal insulin.
* Patients who have access to KakaoTalk via smartphone and are able to communicate with it.
* Voluntarily agreed to participate in this clinical study.

Exclusion Criteria:

* Steroid and immunosuppressant users. But it can be included if patients continuously maintain same drug dose at least three months.
* Patients who are currently taking weight control medications.
* Breastfeeding or pregnant patients
* Patients who do not voluntarily consent to the study
* Anyone deemed unsuitable by the investigator to participate in the study
Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation

NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including Proteus and others.

The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs, and better patient quality of life.

The study population will include male and female spinal cord injury (SCI) and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation and/or blockage.

Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution. Each treatment regimen will consist of a total of 8 treatments, with a washout period between treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury (SCI) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation
* Screening within 30 days of first treatment

Exclusion Criteria:

* Systemic antibiotics within 7 days of first treatment
* Investigational drug or device within 30 days of enrollment
* Current infection that requires treatment with systemic antibiotics
* Recent history of significant autonomic dysreflexia (requiring intervention or treatment)
A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients

The purpose of this study is to o determine whether the modified LP procedure reduces the incidence of PLPH to 5% or lower, to determine whether the modified LP procedure reduces the frequency of epidural blood patch (EBP) usage to 10% or lower of the PLPH population and to identify factors that may contribute to or reduce incidence of PLPH


Eligibility Criteria:
Inclusion Criteria:

* Participants who can sign informed consent
* Participants who have stated willingness to comply with all study procedures and availability for the duration of the study
* Participants receiving a LP per standard of care (SOC) need for diagnostic or therapeutic purposes only
* Participants with Karnofsky Performance Scale (KPS) ≥ 60

Exclusion Criteria:

* Participants with a past medical history of chronic headaches (≥15 days per month) or acute headaches
* Participants with recent neurosurgical device implants such as ventriculoperitoneal shunt
* Participants with more than one dural puncture during the same LP procedure
* Participants have chronic coagulopathy with elevated prothrombin time (PT), Partial thromboplastin time (PTT), and International Normalized ration (INR).
* Participants who are on active anticoagulant or antiplatelet therapy unless stopped such therapy prior to LP per SOC guidance.
* Participants with suspicions of raised intracranial pressure by either clinical assessment or imaging assessment or both
* Participants with severe spinal column deformities, such as scoliosis. Disc diseases are not exclusion criteria XX
* Participants with LP procedural complications that require a needle type or needle size change
Topical Application of Highly Concentrated Water-in-oil Emulsions

The purpose of this study is to I. determine the effect of repetitive application of newly developed silicone based formulations (placebo water-in-oil emulsions) on transepidermal water loss and other physiological skin parameters and II. investigate the skin penetration of the model drug fluorescein sodium in tape stripping studies to determine the in vivo penetration profile from the water-in-oil emulsions.

Water-in-oil emulsions will be applied daily for a period of 4 weeks on the non-dominant volar forearm of voluntary participants. Several physiological skin parameters will be monitored in weekly intervals during the application period. Additional measurements will be carried out immediately before the start of the application and after a treatment-free recovery period of 2 weeks. The untreated forearm will be used as a reference.

Subsequent to the observational study, tape stripping experiments with fluorescein sodium-loaded formulations will be conducted on the non-dominant forearm of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent
* Female or male aged between 18 and 65 years

Exclusion Criteria:

* Pregnancy
* Chronic skin conditions
A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures

An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for mobilization of the cervix during common gynecologic office procedures.

The primary object is to determine the presence of a difference in pain perception between the two instruments.

The secondary objective is to evaluate the differences in the frequency of bleeding, that requires treatment, after removal of the instrument and the need to use an alternative instruments.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Between 18 and 89 years of age
* Undergoing an IUD placement

Exclusion Criteria:

* IUD placement within the last 6 months
* Active cervical or pelvic infection
* pregnant
* Patient taking coagulation medications