louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01126684: Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion
Official title: EFFECTS OF ATORVASTATIN ON BLOOD PRESSURE AND URINARY ALBUMIN EXCRETION IN PATIENTS WITH ESSENTIAL HYPERTENSION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hypercholesterolemia
Keywords: essential hypertension
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, "novel" cardiovascular risk factors and safety parameters will be also evaluated.


Eligibility criteria: Inclusion Criteria:

* LDL-C\>130 or \>160 mg/dL (depending on the total risk according to the most recent recommendations25).
* no previous hypolipidemic medication
* ability to provide Informed Consent.

Exclusion Criteria:

* pregnancy or lactation
* myocardial infarction or unstable angina within the past 6 months
* heart failure NYHA class III-IV
* renal disease (SCr\>3 mg/dL or proteinuria\>3g/d)
* liver disease
* history of malignancy
* history of drug or alcohol abuse
* treatment with corticosteroids
* any other condition with poor prognosis
* inability to provide Informed Consent.

Primary outcomes:
measure: Ambulatory blood pressure
timeFrame: Six months
Secondary outcomes:
measure: Urinary Albumin Excretion
timeFrame: Six months
measure: Insulin Sensitivity
timeFrame: Six months
measure: Arterial Stiffness
timeFrame: Six months
measure: Urinary levels of nephrin
timeFrame: Six months
measure: Urinary levels of podocalyxin
timeFrame: Six months
measure: Urinary levels of Endothelin-1
timeFrame: Six months
measure: Urinary levels of Asymmetric Dimethylarginine
timeFrame: Six months
measure: Urinary levels of indices of oxidative stress
timeFrame: Six months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital of Thessaloniki
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Anastasios Lasaridis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanaki AI, Sarafidis PA, Georgianos PI, Kanavos K, Tziolas IM, Zebekakis PE, Lasaridis AN. Effects of low-dose atorvastatin on arterial stiffness and central aortic pressure augmentation in patients with hypertension and hypercholesterolemia. Am J Hypertens. 2013 May;26(5):608-16. doi: 10.1093/ajh/hps098. Epub 2013 Feb 28.
Clinical trial NCT04372784: Cryoablation for Benign Gastrointestinal Anastomotic Strictures
Official title: A Randomized Controlled Trial of Cryotherapy on Benign Anastomotic Strictures Following Esophagectomy, Gastrectomy, and Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Stricture
Duodenal Stricture
Jejunal Stricture
Anastomotic Stricture of Small Intestine
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 124
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: Anastomotic stricture is a common complication following foregut surgery. The standard of care for these benign foregut anastomotic strictures is balloon dilatation. However, re-stenosis of strictures is also common, requiring frequent repetition of balloon dilatation. Cryotherapy is a novel therapy that may improve clinical outcomes following dilatation. The purpose of the present study is to conduct a randomized controlled trial to characterize the impact of cryotherapy on clinical outcomes and complications for benign anastomotic strictures following esophagectomy, gastrectomy, and bariatric surgery.


Eligibility criteria: Inclusion Critieria

* History of esophagectomywith primary anastomosis
* History of gastrectomy with primary anastomosis
* History of bariatric surgery with primary anastomosis
* History of anastomotic stricture
* History of balloon dilatation at Keck Hospital of the University of Southern California

Exclusion Critieria

* Patients treated at medical centers other than Keck Hospital of the University of Southern California
* History of anastomotic stent placement

Primary outcomes:
measure: Number of Dilatations
timeFrame: One year
Secondary outcomes:
measure: Dilatation size
timeFrame: Immediately after the intervention/procedure/surgery/etc
measure: Perforation rate
timeFrame: Immediately after the intervention/procedure/surgery/etc
measure: Bleeding rate
timeFrame: Immediately after the intervention/procedure/surgery/etc
measure: Fistula rate
timeFrame: One year
measure: Reintervention
timeFrame: One year
measure: Readmission
timeFrame: One year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
Study officials:
References:
Clinical trial NCT05645484: The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma
Official title: The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinically highly suspected or confirmed melanoma underwent 18F-PFPN and 18F-FDG PET scans in the PET center.

Brief summary: This is a monocentric prospective study. This study aims to investigate the prognostic value of the novel melanin-targeted imaging modality 18F-PFPN PET in patients with melanoma and seek independent prognostic factors for progression-free survival (PFS) and overall survival (OS). The patients with clinically highly suspected or confirmed melanoma who underwent 18F-PFPN and 18F-FDG PET scans will be enrolled consecutively. Patients' PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses. This study plans to set the sample size as 100 cases.

Detailed description: Melanoma is an aggressive malignancy with a high mortality rate. Accurate diagnosis and prognostic risk assessment are essential to the clinical management of melanoma. Melanin is present in most melanoma and has become a potential target for melanoma. This team has successfully synthesized a positron nuclide targeting melanin probe named 18F-PFPN (18F-N-(2-diethylaminoethyl)-4-(2-\[2-ethoxy\]-ethoxy) pyridine), which has been proven to be safe and well-tolerated. It has shown excellent diagnostic value in both primary and metastatic melanoma. This prospective study was designed to further investigate the prognostic value of 18F-PFPN for melanoma and compare it with the general metabolic imaging agent 18F-FDG. In this study, patients with clinically highly suspected or confirmed melanoma who underwent 18F-PFPN and 18F-FDG PET scans will be enrolled consecutively. Patients' PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses.

Eligibility criteria: Inclusion Criteria:

* Patients with histopathologically confirmed melanoma;
* Patients with complete clinical and follow-up data (including TNM stage, subtypes, and treatment strategies).

Exclusion Criteria:

* Uncertain histopathology;
* A history of other malignancies.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 1-2 years
measure: Overall Survival (OS)
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: China, Hubei Province
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiaoli Lan, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05501184: SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
Official title: COMPARISON OF SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Disc Herniation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This was a randomized controlled trial conducted to examine the changes in the pain, physical function, quality of life, and kinesiophobia of participants with non-specific neck pain in Marmara University Physiotherapy and Rehabilitation Department. This study was approved by the Clinical Studies Ethics Committee of Marmara University Faculty of Health Sciences in January 2022 and was carried out in accordance with the Declaration of Helsinki. The participants were informed about the study and their consent was obtained.


Eligibility criteria: Inclusion Criteria:

* Participants between the ages of 18-65,
* Who had access to the internet and smartphone,
* Had the ability to conduct video calls were included in the study.

Exclusion Criteria:

* Participants were excluded if they had COVID-19,
* Had surgery in the last 6 months,
* Received physiotherapy treatment.
* Had a condition that prevented them from exercising.

Primary outcomes:
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: The pain was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: The disability was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: The kinesiophobia was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.
measure: Cervical Mobility
timeFrame: The cervical mobility was measured at baseline and at the end of treatment in the 8th week.
measure: Short Form-36 (SF-36)
timeFrame: The quality of life was measured at baseline and at the end of treatment in the 8th week.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT00292084: An Extension Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection
Official title: A Phase II, Multi-Center, Extension Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With or Without Ribavirin, for an Additional 36 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C
Celgosivir
HCV
Genotype 1
Non-responders
End of Treatment Response
Sustained Viral Response
Lead sponsor: BioWest Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2006-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an extension study of HCV-05-002. The objective of this study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.


Eligibility criteria: Inclusion Criteria:

* Patients who completed HCV-05-002 only
* 18-65 years of age, inclusive
* Primary diagnosis of chronic HCV infection
* Non-responders to previous pegylated interferon-based therapy

Exclusion Criteria:

* Patients naive to interferon-based therapy for chronic HCV infection

Primary outcomes:
measure: Safety analysis
measure: HCV viral load reduction from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
state: Nova Scotia
Study officials:
affiliation: BioWest Therapeutics Inc
name: Jim Pankovich
role: STUDY_DIRECTOR
References:
Clinical trial NCT02587702: Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Term Infants
Lead sponsor: Beingmate Baby & Child Food Co Ltd .
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2015-10-27
Enrollment: 90
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants


Eligibility criteria: Inclusion Criteria:

* Healthy full term infants

Exclusion Criteria:

* experienced congenital or chromosomal disorders
* neonatal morbidities, or metabolic illness

Primary outcomes:
measure: Content of fatty acids
timeFrame: 3 years
measure: Content of calcium and magnesium
timeFrame: 3 years
Secondary outcomes:
measure: Anthropometric measurements
timeFrame: 3 years
measure: Stool characteristics assessed via stool frequency
timeFrame: 3 years
measure: Stool characteristics assessed via stool consistency
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
Study officials:
References:
Clinical trial NCT05837702: Pain Management in Laparoscopic Cholecystectomies
Official title: Comparison of the Effects of Erector Spina Plan Block and Paravertebral Block in Laparoscopic Cholecystectomies on Pain Management.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Keywords: Erector Spinae Plane Block
Paravertebral Block
Laparoscopic Cholecystectomy
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.

Detailed description: The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* aged \>18 years
* patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery

Exclusion Criteria:

* Did not provide informed consent,
* Had any psychiatric or mental problem that prevented understanding of the informed consent form
* They were planned to undergo emergency cholecystectomy,
* Had any allergy or hypersensitivity to local anaesthetic,
* Had an infection in the needle entry area
* History of coagulopathy or the use of anticoagulants

Primary outcomes:
measure: Total tramadol consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Visual analog scale (VAS) at rest and when coughing
timeFrame: at 0, 5, 10,20 minutes and 1, 2,4 , 6, 12 and 24 hours postoperatively
measure: Analgesic drug consumption other than tramadol
timeFrame: 24 hours postoperatively
measure: Heart Rate
timeFrame: preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)
measure: Mean arterial pressure (MAP)
timeFrame: preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)
measure: Incidence of postoperative nausea & vomiting (PONV)
timeFrame: 24 hours postoperatively
measure: Shoulder pain
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University Medical School Hospital.
state: Merkez
Study officials:
affiliation: Giresun University
name: elvan tekir yilmaz
role: STUDY_DIRECTOR
References:
Clinical trial NCT03681002: Implementation of a Structured Lifestyle Program in Primary Care. Changes in Lifestyle Habits and Cardiovascular Risk.
Official title: Implementation of a Structured Lifestyle Program in a Primary Care Setting. Changes in Lifestyle and Effects on Cardiovascular Risk in Patients With High Cardiovascular Risk.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lifestyle Risk Reduction
Primary Care
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the present study is to describe and evaluate the effect of a structured lifestyle intervention program, focusing on lifestyle habits, in a primary care setting in patients with high cardiovascular risk. Furthermore, we want to explore the patient´s experience of lifestyle change and counseling after participation in the intervention program and to investigate the cost-effectiveness of the program.

Detailed description: Intervention The intervention program comprises five individual visits to the same nurse, specialised in diabetes care and the metabolic syndrome every three month during one year. The nurse led a person centered dialog based on the answers from a questionnaire. At every visit, focus was primarily on lifestyle habits, using motivational interviewing to strengthen the patient's ability to modify one or more lifestyle habits. Dietary counselling was in accordance with the Swedish recommendation in nutrition. If the patient were in need of extended counseling regarding one or more lifestyle habits, he or she could be referred within the primary care unit to a specialist. During the 12-month period, all patients where offered to participate in evening group sessions at three different occasions. Topics were physical activity, fatty acids, healthy food, tobacco and alcohol, stress, sleep and methods of how to change behavior".

Eligibility criteria: Inclusion Criteria:

Patients diagnosed with

* hypertension
* diabetes mellitus type 2
* impaired glucose tolerance

Exclusion Criteria:

* dementia
* severe psychiatric disease
* difficulties to understand Swedish

Primary outcomes:
measure: Change in physical activity
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Framingham risk score
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Associate professor, Department of Public health and caring sciences; Family medicine and preventive medicin
name: Mattias K Damberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06953102: Prevalence and Association of Anxiety and Sleep Disturbances Among Medical Students.
Official title: The Prevalence and Association of Anxiety and Sleep Disturbances Among Medical Students: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disturbances
Anxiety
Keywords: Sleep disturbances.
Anxiety
Medical students
Pittsburgh Sleep Quality Index (PSQI)
Beck Anxiety Inventory (BAI)
Sleep quality
Lead sponsor: Government Medical College, Patiala
Sponsor class: OTHER_GOV
First posted: 2025-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Students of MBBS

Brief summary: Observational, Cross-sectional study

Detailed description: It was a cross-sectional study conducted in December 2024 with the consent of 200 undergraduate medical students of a tertiary care hospital affiliated medical college, who qualified as per the inclusion criteria.

Inclusion criteria:

All the students of MBBS Phase-II.

Exclusion criteria:

Students with prior diagnosed Sleep disorders Students with prior diagnosed co-morbidities Students unable/unwilling to answer the question.

Eligibility criteria: Inclusion criteria:

- All the students of MBBS Phase-II.

Exclusion criteria:

* Students with prior diagnosed Sleep disorders
* Students with prior diagnosed co-morbidities
* Students unable/unwilling to answer the question.

Primary outcomes:
measure: Assessment of Sleep Disturbances
timeFrame: 1 month
measure: Assessment of Anxiety
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Patiala
country: India
facility: Yuvraj Kaushal
state: Punjab
Study officials:
References: