louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01531049: Smoking Habits and Smoking Cessation in Young Adults
Official title: Smoking Cessation in Young Adults in Northern Finland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Smoking Cessation
Smoking
Habits
Keywords: smoking cessation
young adults
motivational counselling
smoking
nicotine replacement therapy
therapy
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: University of Oulu
name: University of Helsinki
First posted: 2012-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the efficacy and effectiveness of varenicline and nicotine patch combined with motivational interview technique in smoking cessation of young adults over 12 months follow-up.

Detailed description: Most teenage smokers are still smoking when they become adults confirming that stopping of smoking at young age is difficult although majority of young smokers want to quit. Young smokers experience many relapses partly due to the lack of appropriate and available cessation services. The discomfort experienced during cessation attempts is likely to be negatively associated with cessation success. Quitting of smoking is by the far most important procedure in preventing COPD progression. In Finland, 18-35% of young adults smoke, the variability being associated at least with socioeconomic background, education and geographical area. Our recent studies on male military draftees have shown that smoking is much more frequent in Northern than Southern Finland. However young men want to quit and accept new smoking restrictions. Very few studies are available on quitting attempts or counselling, pharmacotherapy and/or their combinations in young adults who want to quit.

Eligibility criteria: Inclusion Criteria:

* healthy daily smokers
* a daily smoker has smoked at least 1cig/day every day during last month and has smoked at least 100 cig ever
* a nonsmoker has smoked less than 50 cig ever,and has not smoked at all during last month
* motivated to quit smoking and ready to 12 months follow-up
* minor allergy or mild asthma without regular medication is allowed

Exclusion Criteria:

* any chronic disease with daily medication
* known allergy to study medications(varenicline, nicotine patch,nicotine gum)
* any substance and/or alcohol abuse
* drop-outs are counted as current smokers

Primary outcomes:
measure: The abstinence rate
timeFrame: 3 months follow-up
Secondary outcomes:
measure: The saliva cotinine verified abstinence rate
timeFrame: 3 months follow-up
measure: The abstinence rate
timeFrame: 1, 6 and 12 months follow-up
Other outcomes:
Locations:
city: Rovaniemi
country: Finland
facility: Lapland Central Hospital, Lapland Hospital District
Study officials:
affiliation: Medical Informatics and Statistics Research Group, University of Oulu
name: Pentti Nieminen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02632149: Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome
Official title: The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Lennox-Gastaut Syndrome
Keywords: PINS Vagus Nerve Stimulator
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Qilu Hospital of Shandong University
name: Qingdao University
name: Linyi People's Hospital
name: Yantai Yuhuangding Hospital
First posted: 2015-12-16
Enrollment: 31
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.


Eligibility criteria: Inclusion Criteria:

1. Age 3-14 year
2. Lennox - Gastaut syndrome diagnostic standard
3. Regular drug treatment is invalid
4. Antiepileptic drug stability in recent 3 months
5. Good health except epilepsy
6. Patients or his(her) familyscould understand this method and sign the informed consent
7. Patients with good compliance and could complete postoperative follow-up.

Exclusion Criteria:

1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions
2. Had epileptic foci excision surgery or corpus callosum
3. The vagus nerve lesion and damage
4. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma， mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication
5. Participated in other clinical drug test subjects within three months
6. The researchers think that is not suitable for participants'

Primary outcomes:
measure: Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
timeFrame: 6 month of stimulation
Secondary outcomes:
measure: Changes in seizure frequency from baseline to the seizure count evaluation period
timeFrame: 1,3,6,months of stimulation
measure: Change from Baseline in the Engel and McHugh description
timeFrame: At 1,3,6 months
measure: Overall WISC Score in Patients from Baseline
timeFrame: Mean change from baseline WISC Overall Score at 1,3,6months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: JiNing
country: China
facility: JiNing First People's Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: QingDao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT05316649: Blood Loss Quantification During Major Abdominal Surgery
Official title: Blood Loss Quantification During Major Abdominal Surgery: Study Protocol for a Prospective Cohort Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Loss, Surgical
Blood Loss, Postoperative
Postoperative Complications
Lead sponsor: University of Defence, Faculty of Military Health Sciences
Sponsor class: OTHER
Collaborators: name: University Hospital Hradec Kralove
First posted: 2022-04-07
Enrollment: 45
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 undergoing for elective liver or pancreas surgery.

Brief summary: Blood loss quantification during surgery remains unreliable and inaccurate. The purpose of the study is compare several methods of blood loss quantification in real surgical settings and to analyze the effect of blood loss on postoperative complications.


Eligibility criteria: Inclusion Criteria:

* patient scheduled for liver or pancreatic surgery
* age of patient ≥ 18 years
* signed informed consent provided

Exclusion Criteria:

* patient coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants).
* use of cell saver suctioning during operation
* damage/clotting of blood samples

Primary outcomes:
measure: Blood loos quantification
timeFrame: 1 year
Secondary outcomes:
measure: Postoperative complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University of Defence, Faculty of Military Health Sciences
Study officials:
affiliation: University of Defence, Faculty of Military Health Sciences
name: Jan Zajak, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05875649: A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure
Official title: A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: AML
Keywords: CLAG
acute myeloid leukemia
First-induction failure
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 137
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute myeloid leukemia patients don't achieve CR after first-induction chemotherapy.

Brief summary: Most of patients with acute myeloid leukemia achieved complete remission (CR) after primary induction chemotherapy, there were 20-30% patients without CR after first-induction. It was uncertain how to treat these patients. It was investigated in our study that these patients were re-induced with CLAG Regimen. The CR ratio, overall survival (OS) and relapsed-free survival (RFS) was statistically analysed in these patients.


Eligibility criteria: Inclusion Criteria:

* Acute myeloid leukemia patients with first-induction failure

Exclusion Criteria:

* Acute myeloid leukemia patients with serious infection and organ dysfunction.

Primary outcomes:
measure: Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction failure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guanzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Xuejie Jiang, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT05323149: Tranexamic Acid in Traumatic Brain Injury
Official title: The Impact of Early Use of Tranexamic Acid in Traumatic Brain Injury Upon the Inflammatory Response and Outcome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Inflammatory Response
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, our aim is to investigate the role of tranexamic acid for modulating the inflammation in patients with traumatic brain injury (TBI).

Detailed description: This is double-blind trial, where group T will be received TXA, where group C will be received saline placebo.

In emergency room (ER), trauma patients will be assessed and managed according to our local hospital protocol. After the initial resuscitation of patients. The selection was done according to the inclusion criteria. Baseline investigations

1. C-reactive protein (CRP), interleukin -6(IL-6), C-reactive protein/Albumin ratio (CAR), complete blood count (CBC) for neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR).
2. Prothrombin concentration (PC), prothrombin time (PT), activated partial thromboplastin time (aPTT), and INR.

Group T, will be received TXA (loading dose of 1gm of TXA, followed by a 1gm of maintenance dose over 8 hours for 48 h). Group C, will be received saline (loading dose of 1gm of saline 0.9%, followed by a 1gm of maintenance saline dose over 8 hours for 48 h) to monitor the post-interventional inflammatory response (CBC for NLR, PLR), CRP, IL-6, C-reactive protein/Albumin ratio (CAR), hemostasis (PC, PT, activated PTT, and international normalized ratio (INR)) and short-term outcome. Conscious level will be assessed by Glasgow come scale (GCS), delirium by Richmond Agitation-Sedation Scale (RASS score) and hemodynamics will be continuously monitored. Patients will be monitored and managed in intermediate or intensive care unit. Adverse effects and complications will be recorded and managed.

Eligibility criteria: Inclusion Criteria:

* Isolated traumatic brain injury patients (mild or moderate cases)
* GCS \> 8
* non penetrating TBI in 8 hours onset
* Age ≥ 18 years

Exclusion Criteria:

* Patient in cardiac arrest
* Patients with coagulopathies
* Renal failure patients
* pregnancy
* Patient refusal to participate

Primary outcomes:
measure: Percentage of patients with decreased the inflammatory response
timeFrame: 48 hours post-interventional (either placebo or TXA)
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
state: Assuit
Study officials:
References:
Clinical trial NCT04072549: Reducing Health Disparities in Childhood Obesity
Official title: Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 651
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will compare changes in weight status and obesogenic behaviors of children from low-income households randomized to one of two conditions: free summer programming or comparison/control.
Primary purpose: PREVENTION

Brief summary: In this study, we will address cost barriers to participating in summer programs and hypothesize this will lead to marked improvements in children's obesogenic behaviors and a reduction in excessive, unhealthy weight gain over summer.

Detailed description: For this study, we will rigorously test the impact of providing access to existing community-operated summer programs on weight status (i.e., BMI z-score) and obesogenic behaviors of 1st-3rd grade children from low-income households. Using a pragmatic, Type II hybrid effectiveness-implementation randomized design, we will compare changes in weight status and obesogenic behaviors of children from low-income households randomized to one of two conditions: free summer programming or comparison/control.

Eligibility criteria: Inclusion Criteria:

1st through 3rd grade students in the participating schools.

Exclusion Criteria:

The only exclusion criteria will be the diagnosis of an intellectual disability, such as:

Autism Spectrum Disorder Down Syndrome Fragile X Fetal Alcohol and/or a physical disability, such as wheelchair use

This decision was made because of the added resources required to evaluate these children, as well as the inability to sample enough of these children to adequately draw conclusions.

No other exclusion criteria will be used.

Primary outcomes:
measure: BMI
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Physical Activity
timeFrame: Baseline and 2 months
measure: Sleep
timeFrame: Baseline and 2 months
measure: Diet
timeFrame: Baseline and 2 months
measure: Screen Time
timeFrame: Baseline and 2 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Michael Beets
state: South Carolina
Study officials:
References:
Clinical trial NCT06506006: A Comparison of Early Outcome of Surgical Management of Proximal Humerus Fracture in Adults During COVID-19 Pandemic- A Prospective Cohort Study
Official title: A Comparison of Early Outcome of Surgical Management of Proximal Humerus Fracture in Adults During COVID-19 Pandemic- A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humerus Surgery in Covid Recovered Patients
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: both group included patients with isolated traumatic proiximal humerus fracture. The post COVID group included patients with tested COVID positive at presentation. The Non COVID group wire non infected population without COVID infection

Brief summary: The goal of this observational study is to learn the outcome of proximal humerus fracture surgery in patients who had it delayed due to COVID infection and compare it with normal patients with same fracture and treatment. The main question it aims to answer is:

• Do the patients with proximal humerus fracture undergoing delayed fixation secondary to COVID infection have the same outcome as that of the normal patients?

The outcome of patients of both group will be assessed objectively via the standard Neer"s shoulder score and compared using independent variable T test.


Eligibility criteria: Inclusion Criteria:

* isolated traumatic proximal humerus fracture (Neer's grading 3 and 4)
* above 18 years of age
* consenting for the study

Exclusion Criteria:

* open fractures: Gustilo Grade II and III
* neurovascular compromise.
* neuromuscular disorders.
* injury severity score \>16
* humerus fracture with extension to shaft

Primary outcomes:
measure: neer's shoulder score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: B.P.Koirala Insitute of Helath Sciences
state: Koshi
Study officials:
affiliation: National Trauma Center
name: ashbin bhattarai, masters
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04255706: Repeatability in Measurements of Two ssOCT and One OLCR Biometer
Official title: Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Senile
Keywords: ss-OCT
OLCR
biometry
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one.

Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR device.

Detailed description: Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome.

ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration.

This a prospective observational study that would include patients which attended pre-surgical examination. A written informed consent will be obtained from each patient.

Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Lenstar LS 700 and Anterion Heildelberg). Each patient will be measured three times with each device and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.

Eligibility criteria: Inclusion Criteria:

* 40 years old or above
* age-related cataract

Exclusion Criteria:

* patients with dense cataract or corneal pathology that would significantly influence biometric measurements
* nystagmus or pathologies that would affect patient fixation
* pregnancy- for women in reproductive age a pregnancy test will be performed.

Primary outcomes:
measure: Evaluation of repeatability between two ss-OCT and one OLCR biometry device
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
Study officials:
affiliation: VIROS, Hanusch Hospital Vienna
name: Oliver Findl, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisus AD, Hirnschall ND, Ruiss M, Pilwachs C, Georgiev S, Findl O. Repeatability of 2 swept-source OCT biometers and 1 optical low-coherence reflectometry biometer. J Cataract Refract Surg. 2021 Oct 1;47(10):1302-1307. doi: 10.1097/j.jcrs.0000000000000633.
Clinical trial NCT05108506: Strict Need to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy
Official title: To Void or Not to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy, That is the Question
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention Postoperative
Keywords: Minimally invasive hysterectomy
Urinary retention
Some day discharge
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Patients who are undergoing non-urogynecologic, minimally invasive (laparoscopic, robotic) hysterectomy who are discharged the day of surgery will be randomized to a strict need to void versus no need to void prior to discharge.

To determine if a strict versus liberal voiding trial following the aforementioned surgery in same day discharge patients increases rates of post-operative urinary retention, urinary tract infection (UTI), or re-presentation and if there is a difference in Post-Anesthesia Care Unit (PACU) time and costs.


Eligibility criteria: Inclusion Criteria:

* Women 18+ undergoing minimally invasive benign, non-urogynecologic hysterectomy
* English speaking

Exclusion Criteria:

* At the surgeons discretion based on amount of bladder dissection the patient can be removed from the study at the conclusion of surgery
* Any patient with a history of prior urologic procedures
* Patients with any baseline known urinary disease
* Any bladder injury at the time of surgery
* Any combined cases with other surgical services
* Patients undergoing surgery for prolapse or incontinence symptoms
* Patients who are ultimately not discharged the same day and remain in house overnight

Primary outcomes:
measure: Amount of time spent in PACU
timeFrame: 2 years
Secondary outcomes:
measure: Rates of urinary retention
timeFrame: 2 years
measure: Rates of UTI
timeFrame: 2 years
measure: Rates of re-presentation to the ER
timeFrame: 2 years
measure: Cost of stay in PACU
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kristin Patzkowsky
role: PRINCIPAL_INVESTIGATOR
References: