louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02262611: Post Marketing Surveillance Study in Rehabilitation Clinics (Cardio, Nephro, Diabetes, Pulmo)
Official title: Post Marketing Surveillance Study in Rehabilitation Clinics (Cardio, Nephro, Diabetes, Pulmo)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 266
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: Patients with hypertension recruited at hospitals in Germany specialized in cardiology, nephrology, diabetology and pneumology

Brief summary: Study to obtain long-term data on effects, safety and tolerability in routine medical practice and to investigate the potential of telmisartan to prevent secondary organ damage


Eligibility criteria: Inclusion Criteria:

* Adult patients of both gender aged \>=18 admitted to a hospital due to insufficiently controlled essential hypertension.

No additional selection criteria have to be considered. Treatment was at the discretion of the physician following the summary of product information for Micardis® and MicardisPlus®

Exclusion Criteria:

* not applicable

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 1 year
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: up to 1 year
measure: Number of patients with clinically significant changes in vital signs
timeFrame: up to 1 year
measure: Change in systolic blood pressure
timeFrame: up to 1 year
measure: Change in diastolic blood pressure
timeFrame: up to 1 year
Secondary outcomes:
measure: Global assessment of efficacy by investigator on a 4-point scale
timeFrame: 2 weeks, after 1 year
measure: Global assessment of tolerability by investigator on a 4-point scale
timeFrame: 2 weeks, after 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04163211: Abdominal Drainage During Appendicectomy - Resources Down the Drain: A Retrospective Cohort Study
Official title: Abdominal Drainage During Appendicectomy - Resources Down the Drain: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Lead sponsor: The Whittington Hospital NHS Trust
Sponsor class: OTHER_GOV
First posted: 2019-11-14
Enrollment: 76
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients over the age of 16 with complicated appendicitis (CA) were included. CA was defined as histologically proven gangrenous or perforated appendicitis.

Brief summary: The investigators performed a retrospective review of all patients undergoing appendicectomy from March-November 2018 using the online theatre database and discharge letters. CA was defined as patients with perforated or gangrenous appendicitis on histology. Patients were divided into 2 groups; Group 1 (G1) included patients with CA who had a drain inserted; Group 2 (G2) included patients with CA and no drain.


Eligibility criteria: Inclusion Criteria:

* All patients over the age of 16 with complicated appendicitis (CA) were included

Exclusion Criteria:

* Patients with evidence of caecal/ appendicular malignancy were excluded.

Primary outcomes:
measure: Intra-abdominal abscess
timeFrame: Up to 6 months post-operative
Secondary outcomes:
measure: Length of stay
timeFrame: 8 months - March to November 2018
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Whittington Hospital NHS Trust
Study officials:
References:
Clinical trial NCT01516411: Promoting Healthy Lifestyles Using Mobile Phones
Official title: Promoting Healthy Lifestyles Using Mobile Phones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Health Promotion
Physical Activity
Sedentary Time
Smartphones
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 130
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to test programs to increase physical activity and reduce sedentary behavior using motivational messages over a cell phone.

Detailed description: We want to learn if conceptually-based behavioral interventions for promoting increased physical activity and decreased sedentary behavior via state-of-the-art mobile phones will be efficacious at improving these behaviors relative to commercially available Android applications as a control. If efficacious, these types of intervention programs could be disseminated to a wide variety of sedentary and underactive adults at a relatively low cost. This could have a potentially significant impact on promoting improved health such as reduced obesity, a key problem within the U.S.

Eligibility criteria: Inclusion Criteria:

* aged 45 and older, currently sedentary, owns and uses a cell phone but not a Smartphone, willing to be randomly assigned

Exclusion Criteria:

* free of clinically evident cardiovascular disease or any other medical condition or disorder that would limit participation in moderate intensity physical activities akin to brisk walking

Primary outcomes:
measure: Time spent being physically active
timeFrame: 2 months
measure: Time spent sitting
timeFrame: 2 months
measure: Changes in food consumption
timeFrame: 2 months
Secondary outcomes:
measure: Beliefs and behaviors about Smartphones
timeFrame: 2 months
measure: Beliefs and behaviors about the Smartphone application
timeFrame: 2 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Prevention Research Center
state: California
Study officials:
affiliation: Stanford Prevention Research Center
name: Abby C King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: King AC, Hekler EB, Grieco LA, Winter SJ, Sheats JL, Buman MP, Banerjee B, Robinson TN, Cirimele J. Effects of Three Motivationally Targeted Mobile Device Applications on Initial Physical Activity and Sedentary Behavior Change in Midlife and Older Adults: A Randomized Trial. PLoS One. 2016 Jun 28;11(6):e0156370. doi: 10.1371/journal.pone.0156370. eCollection 2016.
Clinical trial NCT05485311: The Influence of the Results of Surgical Treatment in Patients With Gunshot and Mine-explosive Wounds on the Formation of Chronic Pain
Official title: The Influence of the Results of Surgical Treatment in Patients With Gunshot and Mine-explosive Wounds on the Formation of Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: chronic pain, surgical treatment, wounds
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 2215
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all patients were injured during hostilities

Brief summary: In 82.1% of patients with gunshot and mine-explosive injuries, the pain becomes chronic. The impact of the results of surgical treatment on the processes of chronic pain in this category of patients remains insufficiently studied. Therefore, the study of such a factor will be important to improve the results of pain treatment.

Detailed description: The influence of the results of surgical treatment in patients with gunshot and mine-explosive wounds on the formation of chronic pain needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Considering that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in the treatment of such patients.

Eligibility criteria: Inclusion Criteria:

* the presence of gunshot and mine-explosive injuries

Exclusion Criteria:

* absence of gunshot and mine-explosive injuries

Primary outcomes:
measure: visual analog scale
timeFrame: 12 months
measure: Didier Bouhassiraa DN4
timeFrame: 12 months
measure: The Hospital Anxiety and Depression Scale
timeFrame: 12 months
measure: Chaban Quality of Life Scale
timeFrame: 12 months
measure: Mississippi PTSD scale (military version)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets National Medical University, Ministry of Health of Ukraine
Study officials:
References:
Clinical trial NCT02860611: Comparison of Th1 Cytokine Levels Between Type 1 and Type 2 Diabetes
Official title: Comparison of Th1 Cytokine Levels Between Type 1 and Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Type 1 diabetes
Type 2 diabetes
T helper 1 cytokines
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used oral antidiabetics but insulin before and 31 healthy subjects (CG).

Brief summary: Recent reports show increased prevalence of obesity in patients with type 1 diabetes (T1DP)s while some studies stated that patients with type 2 diabetes (T2DPs) have islet cell auto-antibodies. These results raise the question of a common pathway in T1DM and T2DM via an association with T helper cells. In this study investigators aimed to investigate the difference between T helper 1 (Th1) cytokines levels in T1DPs, T2DPs and healthy subjects.

The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used oral antidiabetics but insulin before and 31 healthy subjects (CG).

Serum interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α) levels were measured using ELISA method. Serum levels of those cytokines in T1DPs were compared with those in T2DPs and controls.


Eligibility criteria: Inclusion Criteria:

* Being \>18 years old
* Giving consent to participate

Exclusion Criteria:

* Acute and chronic inflammatory diseases
* significant concomitant disease likely to interfere with glucose metabolism,
* malignancies,
* hemoglobinopathies,
* In addition, glucose intolerance (fasting glucose level and that after glucose load) and HbA1C ≥ 5.7 % were also used exclusion criteria in the control group, group as American Diabetes Association (ADA) defined prediabetes as HbA1C between 5.7-6.4% (Standards of medical care in diabetes -2012. Diabetes care. 2012:35.)

Primary outcomes:
measure: Difference in T helper cytokines between groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medeniyet University Goztepe Training and Research Hospital
Study officials:
affiliation: Istanbul Medeniyet University
name: Gonca Tamer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00514111: Factors Associated to Success of Hepatitis C Therapy
Official title: Factors Associated to Success of Hepatitis C Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2007-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HVC patients attended in SAE e HD.

Brief summary: The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.

Detailed description: Chronic hepatitis C virus(HVC) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated three million estimated cases to 52 thousand reports. The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.

Eligibility criteria: Inclusion Criteria:

* HVC patients that received specific treatment with pegylated-interferon or conventional-interferon, and ribavirin

Exclusion Criteria:

* No HVC infection or treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: SAE e Hospital Dia de Aids
state: Sao Paulo
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Alexandre N Barbosa, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02364011: Outcomes Following Total Knee Arthroplasty
Official title: Clinical and Biomechanical Outcomes Following Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis
Keywords: Biomechanics
Primary Total Knee Arthroplasty
TKA Bearings
Osteoarthritis
Total Knee Replacement
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the University of Utah for TKA surgical procedure

Brief summary: The purpose of this investigation is to determine both patient-reported and performance-based outcomes, specifically muscle function and kinematic/kinetic outcomes, between four different surgical total knee prostheses in individuals following TKA. Change scores will be determined based on patient-reported outcomes, kinematic/kinetic data, knee extension strength/power, static/dynamic balance control, mobility measures and functional performance testing during functional tasks (i.e. walking, ascending/descending stairs, sit-to-stand). After evaluating the pattern of change in lower-extremity function, the investigators will be better prepared to address residual functional impairments and prognostic factors linked to maximal recovery over two years.


Eligibility criteria: Inclusion Criteria:

* adults \> 40 years of age that are scheduled for primary TKA
* if they have had a previous TKA, it needs to have been performed on the opposite leg at least 3 months prior to the current TKA
* willing to return for follow-up visits and should be willing and able to be transported from the UOC to the Skeletal Muscle Exercise Research Facility (SMERF), in the Department of Physical Therapy study site for scheduled research follow-up appointments

Exclusion Criteria:

* adult with previous additional orthopaedic, neurological, visual or surgical conditions that may affect gait or balance

Primary outcomes:
measure: Patient Reported Outcome Scores following TKA
timeFrame: Follow Up Visits up to 2-Years
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah
name: Christopher Pelt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771211: Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment
Official title: Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment: A Proof-of-principle Study and Neural Correlates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: MCI
Word-retrieval
tDCS
fMRI
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2013-01-18
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if non-invasive electrical brain stimulation can improve word-retrieval in Mild Cognitive Impairment (MCI).

Detailed description: Previous studies showed that anodal transcranial direct current stimulation (atDCS) can have beneficial effects on word-retrieval in healthy younger and older subjects. The present study aims to extend these findings by assessing whether atDCS can also improve known impairments of word-retrieval in Mild Cognitive Impairment. atDCS will be applied to the left inferior frontal gyrus in a sham controlled cross-over within subjects design. Simultaneous functional magnetic resonance imaging (fMRI) will assess underlying neural effects of the stimulation.

Eligibility criteria: Inclusion Criteria:

* right handed
* German native speakers
* clinical diagnosis of Mild Cognitive Impairment

Exclusion Criteria:

* dementia
* other current or previous neurological or current psychiatric diseases
* alcohol or drug abuse
* MRI contraindication (e.g., magnetic metal, pacemaker, claustrophobia

Primary outcomes:
measure: Number of correct responses during word-generation tasks (max. 60)
timeFrame: Change in number of correct responses between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week
Secondary outcomes:
measure: Neural activity during word-generation task assessed by functional magnetic resonance imaging (fMRI)
timeFrame: Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine, Department of Neurology
Study officials:
affiliation: Charite University Medicine, Department of Neurology
name: Agnes Flöel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936711: Pain Relief After Hiatal Hernia Repair Surgery
Official title: Randomized Prospective Interventional Study: Pain Relief After Laparoscopic Primary Hiatal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Shoulder Pain
Hiatal Hernia
Keywords: Shoulder pain
Hernia
Hernia surgery
Hernia repair
Hiatal hernia
Hiatal hernia surgery
Hiatal hernia repair
Post surgery pain
Lead sponsor: Norton Thoracic Institute
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 90
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: Referred shoulder pain (pain felt when the problem is actually in a different location) is very common after laparoscopic (small, narrow cut) hernia surgery. The purpose of this study is to look at the effect of a simple back massager, which can be readily purchased online or in a store, in addition to the use of standard pain medications.


Eligibility criteria: Inclusion Criteria:

* Scheduled for primary hiatal hernia repair
* Adult 18 years of age or older
* Undergoing minimally invasive surgical technique

Exclusion Criteria:

* Recurrent hiatal hernia
* Children under the age of 18 years
* Undergoing open or hybrid surgical technique
* History of psychiatric disorder or chronic pain
* Has a post-operative complication (Grade \> I on Calvien Dindo classification)
* Allergy to standard pain medication regimen (local anesthetics Marcaine, lidocaine, and epinephrine; morphine; oxycodone; Tylenol)

Primary outcomes:
measure: Visual Analogue Score Pain Questionnaire
timeFrame: 2 years
measure: Opioid and Non-Opioid Usage Postoperative Period
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
Study officials:
affiliation: St. Joseph's Hospital and Medical Center, Norton Thoracic Institute
name: Sumeet K Mittal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06535711: Impact of Acute Computed Tomography on Treatment Decisions and Time to Intervention in Renal Colic
Official title: Impact of Acute Computed Tomography on Treatment Decisions and Time to Intervention in Renal Colic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Stone
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of urolithiasis at the Emergency Department during one year.

Brief summary: This study intend to evaluate the use of acute computed tomography (CT) when acute renal colic, regarding treatment decisions, time to intervention and additional visits to the Emergency Department

Detailed description: All patients with a diagnosis of urolithiasis at the Emergency Department in Helsingborg was included during one year, 1 July 2019 to 30 June 2020. Data regarding size and location of stone, treatment, follow up was extracted from the medical records.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of urolithiasis at the Emergency Department in Helsingborg

Exclusion Criteria:

* Patients with a locked medical record

Primary outcomes:
measure: Rate of interventions
timeFrame: 1 year
measure: Time to intervention
timeFrame: 1 year
measure: Number of additional visits to the Emergency Department
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Department of Urology
Study officials:
affiliation: University of Lund, Sweden
name: Magnus Wagenius, PhD
role: PRINCIPAL_INVESTIGATOR
References: