louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06548906: A Study of GZR4 Injection at Different Injection Sites
Official title: A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).


Eligibility criteria: Inclusion Criteria:

* 1. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
* 2. A Male adult subjects aged 18-55 years old.
* 3. Body mass index (BMI) between 19.0-24.0 kg/m2

Exclusion Criteria:

* 1. Known or suspected hypersensitivity to investigational medical product(s) or related products.
* 2. Participation in a clinical study of another study drug within 3 months prior to randomization.
* 3. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
* 4. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
* 5. More than 14 units of alcohol per week within 3 months prior to randomization
* 6. Smoking more than 5 cigarettes per day within 3 months prior to randomization

Primary outcomes:
measure: AUC0-672h
timeFrame: From Predose to 672 hours after a single dose
Secondary outcomes:
measure: AUC0-∞
timeFrame: From Predose to 672 hours after a single dose
measure: Cmax
timeFrame: From Predose to 672 hours after a single dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Study Site
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Clinical Transparency
role: STUDY_DIRECTOR
References:
Clinical trial NCT06190106: Experiences of Psychotherapeutic Outcomes in Women Victims of Domestic Violence
Official title: Experiences of Psychotherapeutic Outcomes in Women Victims of Domestic Violence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Experiences of Psychitherapeutic Outcomes in Women Victims of Domestic Violence
Keywords: Domestic Violence, Psychotherapy, Psychiatric Symptoms, Intimate Partner Victimization (IPV)
Lead sponsor: Government College University Faisalabad
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: only a single group is studied and their experiences are explored first after screening the psychiatric symptoms of depression, anxiety, and stress and then providing them with Cognitive Behavioral interventions to check the improvement in their Psychiatric symptoms and assess the positive and negative aspects and outcomes of Psychotherapeutic Intervention,
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main objectives of the study are:

1. To explore the experience of undergoing psychotherapy of women victims of domestic violence.
2. To explore the effects of undergoing psychotherapy among women with victims of domestic violence.

Detailed description: Participants:

Purposive sampling techniques would be followed to inquire about the data from the sample. The sample of the present study would be the women who are victims of domestic violence. The study's sample size is 15 which pre and post-testing would be implied. The participants were briefed about the objectives of the present study. Informed consent was taken to ensure the willingness of the participants. First, the DASS test is fulfilled to check out the symptoms caused by domestic violence in women. To fulfill the criteria, they inquired about the topic in detail to get in-depth information from the participants about their experiences and mental health problems caused by domestic violence. Later, they were provided with psychotherapeutic sessions to treat or reduce their mental health problems, and again an in-depth interview about these therapy sessions was conducted to check the effectiveness of the treatment given.

Eligibility criteria: Inclusion Criteria:

* the participants that would be included in the study are females who would be victims of Domestic Violence with the age range of 18 years to 45 years and women who would be eligible for taking psychotherapeutic intervention

Exclusion Criteria:

* women with psychotic disorders would be excluded and those who wouldn't meet the criteria of the DASS test

Primary outcomes:
measure: Depression anxiety and stress scale
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Department of Applied Psychology
Study officials:
affiliation: Government College University Faisalabad
name: Qasir Abbas, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03894306: Understanding How Medication is Stored in the Home
Official title: Understanding How Medication is Stored in the Home
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Poisoning
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients in the buprenorphine clinic, high A1c clinic, or palliative care clinics at NYC Health + Hospitals/Bellevue who are prescribed at least one high-risk medication and have a child less than six years old present in his/her home on average at least 8 hours per week.

Brief summary: The goal of this study is to increase safe medication storage practices in homes with young children in order to prevent unintentional childhood poisonings.

As a step toward meeting this goal, this study aims to determine if an intervention to promote safe storage to patients who have young children in their home, including provision of a lock box or lock bag along with brief counseling versus brief counseling alone, results in 1) increased locked storage (and overall safe medication storage practices) of high-risk prescription medications in the home; 2) increased safe medication storage practices of other medications in the home; and 3) improved safe medication storage related knowledge and attitudes.


Eligibility criteria: Inclusion Criteria:

* Patient in the buprenorphine clinic, high A1c clinic, or palliative care clinic at NYC Health + Hospitals/Bellevue
* Patient prescribed at least one high-risk mediation. A high-risk medication defined as a prescription medication that may cause significant toxicity or death with the ingestion of only one pill or a single adult dose.
* A child less than six years old is present in the patient's home on average at least 8 hours per week.

Exclusion Criteria:

* Inability to speak and read English or Spanish
* No phone number for follow-up or unwilling to do follow-up by phone or in person
* Prior enrollment
* Patient was involved in pilot study

Primary outcomes:
measure: Percentage of patients with locked storage of all high-risk prescription medications at one month follow-up.
timeFrame: 1 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health - Toxicology
name: Mark K Su, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03369106: Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study
Official title: Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multiple Sclerosis siblings Group of siblings having multiple sclerosis, n=120

Brief summary: This study will identify a combination of disease severity markers (genetic, immunology, epigenetic, imaging) associated with disease severity and progression in a cohort of patients with multiple sclerosis.

Detailed description: The heterogeneity of multiple sclerosis evolution relies on several pathophysiological mechanisms including neuroinflammation, neurodegeneration and remyelination and repair mechanisms.

The study will identify markers of disease severity in a longitudinal cohort of patients with multiple sclerosis who are siblings (both siblings having multiple sclerosis) including: biological markers (genetic, immunological and epigenetic markers, advanced MRI markers). An integrative model to predict disease progression will be proposed based on multimodal markers.

Eligibility criteria: Inclusion Criteria:

* Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria)
* Sibling having Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria) willing to participate to the study
* Affiliated to the French social security or equivalent

Exclusion Criteria:

* Cyclophosphamide, mitoxantrone or methylprednisolone infusion within one month before inclusion
* Multiple sclerosis relapse within one month before inclusion
* Concomitant severe or uncontrolled disease

Primary outcomes:
measure: Change of Expanded Disability Status Scale (EDSS)
timeFrame: Baseline and 18 months
Secondary outcomes:
measure: Change in neuropsychological scores
timeFrame: Baseline and 18 months
measure: Change in T2 lesion volume
timeFrame: Baseline and 18 months
measure: Grey matter volume change
timeFrame: Baseline and 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: CIC Neurosciences Institut du Cerveau et de la Moelle Epinière
Study officials:
affiliation: Institut du Cerveau et de la Moelle Epinière
name: Céline Louapre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01156506: Focus Group Interviews of Patients With Permanent or Temporary Enterostomas
Official title: Patient Perspectives on Living With an Enterostoma and Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Perspective
Living With an Enterostoma
Mastery
Empowerment
Keywords: quality of life
patient education
rehabilitation
focus group interview
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2010-07-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of surgery

Brief summary: The study seeks to gain knowledge about new and of alternative ways of organizing ostomy training based on informants' own experiences of life with a stoma.

The study is designed and conducted as qualitative focus group interviews with three different groups of patients with enterostomas (5-8 in each group): a) people with permanent enterostoma due to cancer, 2) people with permanent enterostoma due to non-cancer and 3) people with a temporary ileostomy.

Detailed description: The study is investigating the perspective of the patients who have actually experienced having surgery and living with an enterostoma.

By applying this method it is possible to gain access and in depth knowledge of complex issues including sensitive data. The dialogue with peers can lead to experiments and associations which might stimulate the informants to produce new insights within the individual and in the group.

The interviews will be transcribed in full and analyzed with qualitative content analysis with a phenomenological and hermeneutical approach

Eligibility criteria: Inclusion Criteria:

* Patients with permanent enterostoma due to cancer.
* Patients with permanent enterostoma due to other causes.
* Patients with temporary ileostomy.

Exclusion Criteria:

* Patients with severe mental disorders.
* Patients who do not communicate in Danish.
* Patients with severe hearing impairment.

Primary outcomes:
measure: Educational elements and themes that will optimize rehabilitation and patient education
timeFrame: up until 10 months from interview
Secondary outcomes:
measure: Identification of strategies for improving quality of life
timeFrame: up until 10 months from interview
Other outcomes:
Locations:
Study officials:
affiliation: Herlev University Hospital, department of surgery
name: Anne K. Danielsen, Nurse, MaClN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00206206: Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart
Official title: Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hyperglycemia
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In response to the evidence supporting "tight" glucose control (70 - 110) in the critical care setting, the MMH ICU developed a protocol utilizing regular intravenous insulin. This protocol was initiated in 2002. Monitoring of the data collected revealed effective glycemic control when this protocol was used. However, limited utilization has led to overall ineffective glycemic control in this ICU. The poor utilization is largely due to a general reluctance of physicians to start their patients on an intravenous insulin infusion. As contributing to this poor compliance is the "open" nature of the ICU. The MMH ICU is an "open" ICU, meaning that many physicians across multiple subspecialties admit to this unit. Approaches to controlling hyperglycemia vary greatly, depending largely upon the treating physician. In an attempt to improve overall glycemic control in this "open" ICU, the Subcutaneaous Insulin Aspart Hyperglycemia Protocol (SIAP) was developed which incorporates a subcutaneous insulin aspart regimen that triggers the use of a regular insulin infusion protocol when the SIAP is not adequately controlling the patient's blood glucose.

This study aims to evaluate 1) the effect the SIAP on overall glycemic control in the ICU, 2) the effectiveness that the SIAP has on controlling blood glucose as compared with past practices using regular insulin, and 3) the effect the SIAP has on patient complications and outcomes in the MMH ICU.


Eligibility criteria: Inclusion Criteria: Valid physician order of the protocol. -

Exclusion Criteria: No valid phycician order for the protocol

-

Primary outcomes:
measure: 1) to evaluate the effect a subcutaneous insulin aspart hyperglycemia protocol on overall glycemic control in an ICU.
measure: 2) to evaluate the effect an insulin aspart hyperglycemia protocol has on controlling blood glucoses as compared with past practices of a regular insulin regimen.
measure: 3) to assess the effect a hyperglycemis i9nsulin aspart protocol has on patient outcomes in this ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Memorial hospital
state: New Jersey
Study officials:
affiliation: Moristown Memorial Hospital
name: Rebecca Griffith
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04840706: Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD
Official title: Open-Label Prospective Study Comparing Long-Term Outcome With or Without High-flow Nasal Cannula AirvoTM in Patients With Stable Hypercapnic COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-12
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.

Detailed description: When compared to NIV, much less experience is available from clinical studies on HFNC therapy. Until now, few studies have investigated the effect of HFNC therapy on hypercapnic COPD patients and the number of patients recruited in these studies is limited. AirvoTM therapy could be good choice of treatment for those COPD patients that are not compliant to NIV but need treatment for hypercapnia in order to reduce COPD exacerbations and enhance QOL.The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.

Eligibility criteria: Inclusion Criteria:COPD patients 1) with at least two acute moderate or severe exacerbations during past 12 months, 2) who at the follow-up visit one month after an acute severe exacerbation of COPD are hypercapnic (capillary pCO2 \>6.5 kPa) and not willing to use NIV or have used it less than 4 h/d during the last month despite optimal settings prescribed by an experienced pulmonologist, or if a patient at the follow-up one month after a severe exacerbation is hypercapnic and is willing to try NIV (initiated at the follow-up visit, not at the ward), but then uses it less than 4h/d during the following month. Acute moderate (treated with short acting bronchodilators plus antibiotics and/or oral corticosteroids) and severe (patient requires hospitalization or visits the emergency room) exacerbations of COPD are defined according to the GINA Guidelines (GOLD 2019).

Exclusion Criteria: 1) OSA (diagnosed OSA or high suspicion OSA because of regular snoring, witnessed apneas and daytime sleepiness), 2) neuromuscular or chest wall disease, 3) BMI\>35 kg/m2 or 4) a patient is not able to give his/her informed consent for the study.

Primary outcomes:
measure: pCO2
timeFrame: 1 year
measure: Acute exacerbation rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
Clinical trial NCT00358306: The Role of Endothelium Dysfunction in Progression of CKD (Chronic Kidney Disease) After AKI (Acute Kidney Injury)
Official title: The Role of Endothelium Dysfunction in Progression of CKD (Chronic Kidney Disease) After AKI (Acute Kidney Injury)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
Chronic Kidney Failure
Endothelial Dysfunction
Hemolytic-uremic Syndrome (HUS)
Keywords: Endothelium
Chronic Kidney Disease
Acute Kidney Injury
Hemolytic-uremic syndrome (HUS)
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2006-07-31
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 2-20 years old with history of acute kidney injury

Brief summary: To understand how AKI (Acute Kidney Injury) leads to chronic kidney disease so therapies can be found to alter the progression of events thereby significantly impacting the long-term outcomes of children who develop AKI.

Detailed description: This research study is designed to study what happens to the kidneys after they have an injury. There is some evidence that even if there appears to be great improvement of kidney function, an injury can put patients at risk for long-term problems with their kidney function and increase their risk to have high blood pressure. We want to collect information from participants to help explain why this injury can cause future problems, including Chronic Kidney Disease (CKD) which may help us prevent these health problems.

Eligibility criteria: Inclusion Criteria:

* Children between age 2-20
* Decrease in renal function by 25% or greater
* Renal function has returned to normal

Exclusion Criteria:

* History of chronic disease
* Cancer
* Congenital heart disease
* Organ Transplantation
* Liver disease
* Pulmonary disease
* Diabetes other primary metabolic condition
* Severe neurologic impairments
* Hypertension
* Auto-immune
* Infectious disease or renal disease
* Smokers
* Renal disease w/primary cause i.e. - HUS or Glomerulonephritis
* severe allergies including allergy to seafood and/or iodine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama
state: Alabama
Study officials:
affiliation: UAB Pediatric Nephrology
name: David Askenazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05453006: HPV Self-Sampling in Somali Women
Official title: Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women Through a Primary Care-based HPV Self-sampling Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Papillomavirus Infection
Uterine Diseases
Uterine Cervical Disease
Keywords: DNA virus infections
virus diseases
infections
tumor virus infections
papilloma
uterine diseases
uterine cervical diseases
Somali women
primary care
cancer screening
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 5680
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid Type 2 effectiveness-implementation study; difference-in-difference methods to compare between-period changes in 3 intervention and Fairview non-intervention clinics.
Primary purpose: SCREENING

Brief summary: This study plans to assess the effect of implementing HPV self-sampling in primary care on uptake of cervical cancer screening in 30-65 year old Somali women who are due for cervical cancer screening.


Eligibility criteria: Inclusion Criteria:

* Identify as a Somali woman
* between ages of 30-65
* eligible for cervical cancer screening

Exclusion Criteria:

* Ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix

Primary outcomes:
measure: Cervical cancer screening uptake rate
timeFrame: up to one-year (time-to-event) following intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Rebekah Pratt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Rachel Winer, PhD
role: PRINCIPAL_INVESTIGATOR
References: