louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06831695: Comparison of Surgical Outcomes of Craniotomy and Craniectomy in Posterior Fossa Lesions
Official title: Comparison Between Surgical Outcomes of Craniotomy and Craniectomy Among Patients with Posterior Fossa Lesion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Posterior Fossa Lesion
Keywords: Craniotomy
Craniectomy
Neurosurgery
Posterior Fossa
Brain Tumors
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled trial is to compare the surgical outcomes of craniotomy and craniectomy among patients with posterior fossa lesions. The study aims to determine differences in post-operative complications, hospital stay duration, and patient recovery between the two surgical techniques.

Detailed description: Patients diagnosed with posterior fossa lesions will be randomly assigned into two groups. Group A will undergo craniotomy, where the bone flap is replaced after dural closure, while Group B will undergo craniectomy, where the bone is permanently removed. Outcomes will be assessed based on post-operative complications such as CSF leakage, pseudomeningocele formation, post-operative headache, and length of hospital stay. The study aims to provide evidence to determine the superior surgical approach in terms of patient outcomes and healthcare cost reduction.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with posterior fossa lesions
* Age range: 7-70 years
* Patients with cerebellar hematoma (traumatic or spontaneous)

Exclusion Criteria:

* Previous posterior fossa surgery
* Brainstem hematoma
* Tumors involving the overlying dura or bone

Primary outcomes:
measure: Incidence of CSF leakage
timeFrame: Up to 6 months post-surgery
measure: Occurrence of pseudomeningocele
timeFrame: Up to 6 months post-surgery
measure: Severity of post-operative headache
timeFrame: Immediately post-surgery, at 3 months, and at 6 months post-surgery
measure: Length of hospital stay
timeFrame: From immediate post-surgery until hospital discharge, assessed up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04568395: Acute Effects of TCIG vs ECIG in PLWH
Official title: Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: E Cigarette Use
Vaping
Smoking
Tobacco Smoking
Nicotine Use Disorder
Qt Interval, Variation in
HIV I Infection
Oxidative Stress
Inflammation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
First posted: 2020-09-29
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Crossover with 1 week washout
Primary purpose: BASIC_SCIENCE

Brief summary: Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.

Detailed description: On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.

Eligibility criteria: Inclusion Criteria:

Chronic (\> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 \>500

Exclusion Criteria:

Known major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis \>2 alcoholic drinks per day Obesity (\>30 kg/m2) Recent (\<3 months) infection

Primary outcomes:
measure: Tpe
timeFrame: Change in Tpe 5 minutes after cigarette use
measure: Tpe/QT
timeFrame: Change in Tpe/QT after cigarette use
measure: Tpe/QTc
timeFrame: Change in Tpe/QTc after cigarette use
measure: Total Cellular Reactive Oxygen Stress
timeFrame: within 4 hours of cigarette use
Secondary outcomes:
measure: QT
timeFrame: Change in QT after cigarette use
measure: QTc
timeFrame: Change in QTc after cigarette use
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Los Angeles
country: United States
facility: UCaliforniaLA
state: California
Study officials:
References:
Clinical trial NCT00850395: Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection
Official title: Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1
Keywords: HIV-1
non-interventional
CCR-5 tropic virus
therapy experienced patients
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-02-25
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 infected, therapy-experienced patients, CCR5-tropic virus,

Brief summary: Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®.

Detailed description: Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).

Eligibility criteria: Inclusion Criteria:

HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,

Exclusion Criteria:

X4 or D/M tropic virus. Therapy-naive patients.

Primary outcomes:
measure: Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12
timeFrame: Baseline, Month 12
measure: Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3
timeFrame: Month 3
measure: Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
timeFrame: Month 6
measure: Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12
timeFrame: Baseline, Months 6, 12
measure: Number of Participants With Human Immunodeficiency Virus (HIV) Response
timeFrame: Month 12
measure: Physician's Assessment of Efficacy
timeFrame: Month 12
measure: Number of Participants Taking Concomitant Therapy
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06348095: Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia
Official title: Effect of Probiotic WecProB on the Course of Mycoplasma Pneumoniae Pneumonia in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mycoplasma Pneumoniae Pneumonia
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with mycoplasma pneumoniae pneumonia, in comparison with placebo.


Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria for pneumonia in "Zhufutang Practical Pediatrics" (7th Edition), and is diagnosed with Mycoplasma pneumoniae pneumonia using tNGS technology;
2. Infants and young children aged 6 months to 3 years;
3. The course of the disease is \<48 h;
4. The family members of the children are informed about the study and sign the informed consent form.

Exclusion Criteria:

1. Previous history of wheezing;
2. Cardiovascular disease and congenital tracheal dysplasia;
3. pneumonia induced by other causes;
4. Dysplasia of bronchial and pulmonary tracts;
5. premature infants;
6. Combined with immunosuppressive diseases;
7. Presence of mental illness.

Primary outcomes:
measure: Mycoplasma pneumoniae load
timeFrame: 7天
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04707495: Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression
Official title: Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subthreshold Depression
Lead sponsor: Gunma University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major depressive disorder (MDD) is an important public health problem. Thus, preventive interventions against subthreshold depression (StD), which is one of the key risk factors for the development of MDD, are important. The study developed a smartphone application (SPSRS) that improves depressive symptoms in people with StD by automatically presenting positive word stimuli during videos. The SPSRS application has the potential to improve depressive symptoms in people with StDs. However, whether it can immediately improve depressed moods in people with StD is unclear. The study aims to investigate the immediate effects of SPSRS applications on depressed mood in people with StD.


Eligibility criteria: Inclusion Criteria:

1. Male and female
2. 20 to 39 years old
3. Beck Depression Inventory-II (BDI-II) score of 10 points or more
4. Persons with written informed consent prior to participation

Exclusion Criteria:

1. History of mental illness
2. Currently receiving treatment from a professional for mental health issues
3. Vision or hearing problems that interfere with daily life.
4. With a major depressive episode in the last two weeks according to the Mini-International Neuropsychiatric Interview

Primary outcomes:
measure: Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short)
timeFrame: Change of POMS 2-A Short from baseline at the end of 10 minutes of intervention.
Secondary outcomes:
measure: State-Trait Anxiety Inventory State (STAI-S)
timeFrame: Change of STAI-S from baseline at the end of 10 minutes of intervention.
Other outcomes:
Locations:
city: Maebashi
country: Japan
facility: Gunma University
state: Gunma
Study officials:
References:
Clinical trial NCT04023695: Trigger Finger Corticosteroid Injection With and Without Local Anesthetic
Official title: Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trigger Finger
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic.

Detailed description: The treatment of trigger finger involves an injection of corticosteroid. Corticosteroid treats the underlying inflammatory pathology. Some surgeons add lidocaine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is associated with a burning sensation and may be the primary pain associated with the injection. We hypothesize that a corticosteroid injection without lidocaine with epinephrine will be less painful, and equally effective in treating trigger finger

Eligibility criteria: Inclusion Criteria:

* At least 18 years old with trigger finger

Exclusion Criteria:

* Preference for open trigger finger release
* Not a candidate for corticosteroid injection
* Contraindication to lidocaine with epinephrine

Primary outcomes:
measure: Pain Outcome: Visual Analog Scale
timeFrame: Assessed 1 minute after injection (in clinic)
measure: Pain Outcome: Visual Analog Scale
timeFrame: Assessed after 24 hours after injection (by phone)
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT00798395: A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)
Official title: A Randomized Double-blind, Placebo-controlled, 4-period Cross-over Study to Assess the Effect of Single and Multiple Doses of 1.5 mg and 4.5 mg Org 50081 and a Single Dose of 7.5 mg Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Initiation and Maintenance Disorders
Mental Disorders
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Subject has at least 3 years of car driving experience
* Subject signs the trial Informed Consent Form
* Subject is in a healthy condition as judged by the investigator
* Subject has a regular sleep pattern

Exclusion Criteria:

* Subject has insomnia or any other sleep disorder
* Medication or drug use of any kind prior to the study
* Relevant history or presence of a significant medical illness

Primary outcomes:
measure: The Standard Deviation of Lateral Position
timeFrame: Day 8
Secondary outcomes:
measure: Psychomotor and cognitive performance tasks
timeFrame: Day 8
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06112795: Exploring Cultural Acceptability of Community Breast Cancer Risk Assessment Among Hispanic Women in Maricopa County
Official title: Exploring Cultural Acceptability of Community Breast Cancer Risk Assessment Among Hispanic Women in Maricopa County
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma
Breast Cancer
Breast Cancer Female
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 25
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Under and uninsured Hispanic women living in Maricopa county

Brief summary: This study explores the cultural acceptability of community breast cancer risk assessment among Hispanic women in Maricopa county.

Detailed description: PRIMARY OBJECTIVES:

I. Examine the association between perceived risk and mammography screening behavior and differences in perceived risk by patient characteristics in Hispanic women screened at Mountain Park Health Center (MPHC).

II. Characterize attitudes, beliefs, and barriers towards mammography screening and cultural acceptability of BRCA models in community settings using focus group and interview data from under- and uninsured Hispanic women in Maricopa County.

OUTLINE: This is an observational study.

Participants attend an interview or participate in a focus group on study.

Eligibility criteria: Inclusion Criteria:

* AIM 1:

  * Completed a baseline survey for the Latinas Learning about Density (LLEAD) study
  * Self-identify as Hispanic
  * Between 40-65 years of age
* AIM 2:

  * Between the ages of 45 and 65
  * Self-identify as Hispanic
  * Current residence in Maricopa County
  * Be under- (e.g. Arizona Health Care Cost Containment System) or uninsured at the time of enrollment
  * Can read and speak English or Spanish well enough to understand and complete the informed consent process and take part in either a focus group or individual interview

Exclusion Criteria:

* AIM I:

  * Women with a history of breast cancer
* AIM 2:

  * Women with a history of breast cancer

Primary outcomes:
measure: Mammography screening behavior
timeFrame: Baseline (at enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Jessica D. Austin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04002895: What the Body Does to Foliglurax in Healthy Volunteers
Official title: Interventional, Open-label, Single-dose Study Investigating the Absorption, Metabolism and Excretion (AME) of Foliglurax (Lu AF99757) Following Oral Dosing of 14C-foliglurax to Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 6
Sex: MALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.

Detailed description: Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.

Eligibility criteria: Inclusion Criteria:

- Healthy men with a body mass index (BMI) of 19-30 kg/m2 (inclusive), and with a body weight of minimum 60 kg at the Screening Visit.

Exclusion Criteria:

- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Total amount of radioactivity excreted
timeFrame: Before dosing until day 11
measure: AUC(0-inf) foliglurax
timeFrame: From day 1 until day 11
measure: Cmax foliglurax
timeFrame: From day 1 until day 11
measure: CL/F foliglurax
timeFrame: From Day 1 until Day 11
measure: Total recovery of the administered dose
timeFrame: Before dosing until day 11
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: GB1050 Covance
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT06557395: UNMET CARE PERCEPTIONS OF INTENSIVE CARE NURSES
Official title: UNMET NURSING CARE PERCEPTIONS OF INTENSIVE CARE NURSES: A QUALITATIVE STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nurse's Role
Keywords: care perception, patient, nurse, unmet care, intensive care
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 1
Sex: ALL
Minimum age (years): 23
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study comprised research with qualitative design completed with intensive care nurses.

Brief summary: This study was conducted to determine the perceptions of intensive care nurses regarding unmet care. A qualitative descriptive approach. The study was completed between April and September 2023 by conducting semi-structured individual interviews with 20 intensive care nurses in a Training and Research Hospital in Turkey and analyzed using the inductive content analysis method.

Detailed description: Unmet nursing care may occur due to systemic, institutional or nursing-related reasons. Reasons such as insufficient staff and equipment, excessive workload (Pereira et al., 2020), confusion between disciplines, and failure to prioritize care play an important role in missed care (Chaboyer et al., 2021; Dutra \& Guirardello, 2021; Kılıç et al., 2023). In summary, while improvements should be made in nursing care practices to ensure patient safety and quality of care, systemic improvements should also be made. In order to make these improvements, it should be determined what the missed nursing care experienced and perceived in the clinical field is and what causes them. This research was conducted to determine the perceptions of intensive care nurses about unmet nursing care. This study is a qualitative design research conducted with intensive care nurses. In the study, a purposeful sample selection was made in accordance with the qualitative research approach. The number of participants was determined according to data saturation and is based on the volunteering of a total of 20 intensive care nurses. During the interview, the participants were asked a personal information form and expert opinion on the subject, as well as in-depth interview questions in a semi-structured information form consisting of eight questions.

Eligibility criteria: Inclusion Criteria:

* working in intensive care
* volunteering to participate in the study

Exclusion Criteria:

* not volunteering to participate in the study

Primary outcomes:
measure: What is the perception of care among intensive care nurses?
timeFrame: April-September 2023
measure: What are the thoughts of intensive care nurses regarding the perception of unmet care?
timeFrame: April-September 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
state: Atakum
Study officials:
References: