louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00603499: Magnesium and Metabolic Syndrome
Official title: Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
High Blood Pressure
Hypomagnesemia
Keywords: Diabetes
Hypertension
Hypomagnesemia
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2008-01-29
Enrollment: 85
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective : to test the BP lowering-effect of oral magnesium supplementation, as magnesium chloride (MgCl2) solution, 2.5 g daily, in uncomplicated hypertensive type 2 diabetic subjects with decreased serum magnesium levels Design : Randomised double blind placebo controlled trial. Setting : Outpatients with type 2 diabetes from Durango, city in northern Mexico Subjects : 82 subjects between 40 and 75 years of age with type 2 diabetes serum magnesium deficiency and uncomplicated hypertension.

Interventions : During 4 months the intervention group received 2.5 gr of magnesium chloride (50 ml of a solution containing 50 gr of MgCl2 by 1000 ml of solution ). Controls received inert placebo.

Main outcome measure: Change in blood pressure. Increase of serum magnesium Secondary outcomes measures: Changes in lipid profile


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Decreased serum magnesium levels
* Uncomplicated hypertension
* 40 and 75 years of age
* Men and Women

Exclusion Criteria:

* Chronic diarrhea
* Alcohol intake (equal or more than 30 g per day)
* Use of diuretics and/or calcium antagonists drugs
* Previous oral magnesium supplementation
* Ischemic diseases; AND
* Reduced renal function

Primary outcomes:
measure: Reduction in the systolic and diastolic blood pressures
timeFrame: 2 y
Secondary outcomes:
measure: Average increase of serum magnesium levels Changes in lipid profile
timeFrame: 2 y
Other outcomes:
Locations:
city: Durango
country: Mexico
facility: Biomedical Research Unit
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Martha Rodriguez-Moran, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06674499: Development and Evaluation of a Self-Management Model for Cancer Rehabilitation
Official title: A Randomized Controlled Clinical Trial on the Development and Evaluation of a Self-Management Model for Cancer Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Rehabilitation
Psychotherapy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participants were primarily recruited from medical institutions, specifically targeting newly diagnosed patients with malignant tumors. They were randomly assigned to two different rehabilitation models using block randomization: the cancer self-help rehabilitation model or the conventional rehabilitation model.

During the intervention period, trained oncology advanced practice nurses conducted weekly questionnaire surveys for enrolled patients. During the follow-up period, these surveys were conducted every four weeks. Peripheral venous blood samples were collected at baseline and at weeks 0, 4, 8, and 12 after the intervention began to test for biomarkers related to emotional distress.


Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed with head and neck malignancy.
* Experiencing psychological distress.
* Aged between 18 and 70 years.
* Patients scheduled to receive antitumor treatment in a day hospital or outpatient setting.
* ECOG performance status score of 0-2.
* Patients voluntarily participate, fully understand, and are able to independently complete the questionnaires.

Exclusion Criteria:

* A history of other malignancies within the past 5 years.
* A history of any mental illness, including but not limited to: generalized anxiety disorder, depressive disorder, panic disorder, schizophrenia, or bipolar disorder.
* Patients currently receiving other psychological treatments or taking psychiatric medications.

Primary outcomes:
measure: Degree of improvement in emotional distress
timeFrame: 16 weeks
Secondary outcomes:
measure: Levels of improvement in quality of life
timeFrame: 16 weeks
measure: Levels of anxiety and depression
timeFrame: 16 weeks
measure: Levels of Supportive care needs
timeFrame: 16 weeks
Other outcomes:
measure: Levels of Peripheral stress biomarkers
timeFrame: 16 weeks
Locations:
city: Chengdu
country: China
facility: WestChina Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT02046499: A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section
Official title: A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Post Partum Haemorrhage
Keywords: Prevention, post partum haemorrhage
Lead sponsor: University of Pretoria
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section


Eligibility criteria: Inclusion Criteria:

* Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent

Exclusion Criteria:

* • Women not willing or women not able to provide consent

  * Women who have a classical caesarean section
  * Women younger than 18 years of age
  * Women with any of the following conditions will be excluded (ergometrine contra-indicated in patients with these conditions).
  * Pre- eclampsia
  * Eclampsia,
  * Uncontrolled hypertension (hypertension defined as systolic blood pressure more than 140 mm Hg and diastolic blood pressure more than 90 mm Hg)
  * Any cardiac lesion
  * Impaired liver function
  * Impaired kidney function
  * Hypersensitivity to any of the active ingredients of the preparations that will be used (Syntometrine® or Syntocinon®)
  * Occlusive vascular disease
  * Autoimmune vasculitis

Primary outcomes:
measure: Blood loss
timeFrame: 60 minutes
Secondary outcomes:
measure: Side effects of oxytocin compared to oxytocin + ergometrine
timeFrame: 24 hours
measure: Need for additional uterotonics
timeFrame: 60 minutes
measure: Number of units blood transfused
timeFrame: 24 hours
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Kalafong Academic Hospital
state: Gauteng
Study officials:
affiliation: Department Obstetrics & Gynaecology, University of Pretoria, South Africa
name: Leon C Snyman, MbChB MMed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05370599: Hypertension in Young Adults Trial
Official title: Hypertension in Young Adults Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 3x3 by BP agent and BP monitoring approach
Primary purpose: TREATMENT

Brief summary: This is a pilot randomized controlled trial which will test the effect of 3 different anti-hypertensive agents and 3 different strategies of engaging young adults in home blood pressure monitoring on blood pressure control, with secondary outcomes focused on quality of life and adverse events.


Eligibility criteria: Inclusion Criteria:

* 18-40 years of age
* Diagnosis of hypertension or receiving anti-hypertensive therapy OR Has clinical BP readings \>130/80 mmHg that would meet the definition of hypertension and have home BP readings \>=125/80 mmHg

Exclusion Criteria:

* are or are planning to become pregnant, due to inability to take multiple classes of anti- hypertensive agents
* are marginally housed, due to concerns regarding routine follow-up
* are actively participating in a different interventional trial that may affect blood pressure
* are unwilling to consent to participate
* institutionalized individuals or prisoners
* are actively abusing illicit drugs or alcohol
* have a history of poor or doubtful compliance (e.g., frequently missed appointments)
* have cognitive impairment prohibiting participation in the study
* History of allergy to any of the randomized medications
* Serum potassium \>5.5 meq/L at the screening visit
* BP \> 160/100 mmHg in clinic (stage II hypertension), regardless of whether patient is on therapy
* eGFR \< 30 mL/min/1.73 m2

Primary outcomes:
measure: Achieved systolic blood pressure
timeFrame: Month 6
Secondary outcomes:
measure: Adherence to home BP monitoring
timeFrame: Between month 0 and 6
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elaine Ku, MD MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson HM, Warner RC, Bartels CM, LaMantia JN. "They're younger... it's harder." Primary providers' perspectives on hypertension management in young adults: a multicenter qualitative study. BMC Res Notes. 2017 Jan 3;10(1):9. doi: 10.1186/s13104-016-2332-8.
Clinical trial NCT00460499: Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glycemic Control
Keywords: Diabetes
Lead sponsor: American Heart Association
Sponsor class: OTHER
First posted: 2007-04-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.

Detailed description: Our previous study has shown that maintaining serum glucose between 120-180mg/dl in the perioperative period during CABG surgery in diabetic patients improves outcomes. The purpose of this trial is: (1) to determine whether outcomes can be improved by altering the content of glucose or insulin in these solutions (2)to determine the effect of these solutions and glycemic control on the inflammatory response of arterial and venous conduits used during surgery, (3) to determine whether the beneficial effects of improved glycemic control can be correlated with changes in the inflammatory response.

Eligibility criteria: Inclusion Criteria:

* Diabetic CABG patients

Exclusion Criteria:

* Renal and hepatic failure

Primary outcomes:
measure: glycemic control, postoperative morbidity, inflammatory markers
timeFrame: 24 hours following surgery
measure: glycemic control
timeFrame: 24 hours following surgery
Secondary outcomes:
measure: free fatty acid levels
timeFrame: 24 hours following surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Harold L Lazar MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lazar HL, McDonnell MM, Chipkin S, Fitzgerald C, Bliss C, Cabral H. Effects of aggressive versus moderate glycemic control on clinical outcomes in diabetic coronary artery bypass graft patients. Ann Surg. 2011 Sep;254(3):458-63; discussion 463-4. doi: 10.1097/SLA.0b013e31822c5d78.
Clinical trial NCT00477399: Long Term Follow up After 1 Year Initial Lifestyle Intervention
Official title: Effect of Four Years Intensive- Versus Regular Follow up, After a One Year Weight Loss Period, in Patients With Morbid Obesity.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss maintenance
QOL
Life Style
Follow Up
Lead sponsor: Evjeklinikken
Sponsor class: OTHER
Collaborators: name: Sykehuset i Vestfold HF
First posted: 2007-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of non-surgical methods for obesity treatment are not fully documented. This study focus on the long term effect of an intensiv follow up (the "Evje Model") compared to a regular follow up.

The "Evje Model" is a combined model, consisting of repeated stays at a specialist centre, telephone follow up at home, home groups, self monitoring and close contact with the patients' local physician.

Detailed description: 200 patients will undergo a 1 year intensive lifestyle intervention.This group will be randomised into an intervention group (n=100) and a control group (n=100). The intervention group will undergo four years of further follow up in accordance with the intervention model, which means two one weeks stays each year at the Evje Clinic, telephone follow up, self monitoring and collaboration with the patients' local physician.

The control group will be followed up by the patients local physician and a yearly control at the Center for Morbid Obesity at Vestfold Hospital (Sykehuset i Vestfold HF).

The purpose is to measure the effect of these two follow up models in regard to weight loss maintanance, Quality of Life and comorbidities.

Eligibility criteria: Inclusion Criteria:

* Patients, referred from Public Hospitals, with morbid obesity that have undergone one year intensive life style intervention in accordance with the Evje Model.

Exclusion Criteria:

* Pregnancy, major and active psychiatric disease, active and serious eating disorder

Primary outcomes:
measure: Weight loss
timeFrame: 03.2015
Secondary outcomes:
measure: Health related quality of life
timeFrame: 03.2015
measure: Anthropometrics
timeFrame: 03.2015
Other outcomes:
Locations:
city: Evje
country: Norway
facility: Evjeklinikken AS
state: Evjemoen
Study officials:
affiliation: Sykehuset i Vestfold HF
name: Joran Hjelmesath, Dr. Med.
role: STUDY_CHAIR
References:
citation: Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.
Clinical trial NCT05040399: Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates
Official title: Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sternal Fracture
Sternal Wound Infection
Surgical Site Infection
Keywords: sternum
wound infection
locking compression plates
sternal wires
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-Control
Primary purpose: TREATMENT

Brief summary: Sternal Wound Infection (SWI) in open heart surgery is one of the most annoying and avoidable complications that one encounters during work. Investigators investigate the rates of sternal wound infection (SWI) in patients in whom were used locking compression plates (LCP) versus in patients in whom were used wires to fixate the sternum for variable causes. SWI increases the overall cost and burden in the medical service and increases the patients suffering and disability. investigators aim to provide our patients with the most suitable means for sternal fixation.


Eligibility criteria: Inclusion Criteria:

* All genders are accepted
* Ages from 18 to 80 years old
* Patients undergoing Open heart surgery for any reasons and trauma patients who suffer sternal fractures of any type.

Exclusion Criteria:

* Ages less than 18 years old and older than 80 years old
* Patients undergoing minimally invasive surgeries utilizing access sites other than the sternum.
* Trauma patients with multiple complex injuries.

Primary outcomes:
measure: Sternal Wound Infection rate
timeFrame: 3 weeks post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty Of Medicine
Study officials:
References:
Clinical trial NCT00564499: SYMBICORT® in the Treatment of COPD
Official title: A Scientific Research Program to Evaluate the Efficacy of SYMBICORT® 320/9μg in the Treatment of COPD in Real Life Environment by General Practitioners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Symbicort
General Practitioners
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-11-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients

Brief summary: A Scientific Research Program to evaluate the efficacy of SYMBICORT® 320/9μg in the treatment of COPD in real life environment by General Practitioners


Eligibility criteria: Inclusion Criteria:

* patients (m/f) with COPD (GOLD stadium III and IV)

Exclusion Criteria:

* patients who recently quit smoking (\<3months)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Université Libre de Liège
name: E Louis, PR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04802499: Turkish Version of Telehealth Satisfaction Survey (TeSS)
Official title: Investigation of the Validity and Reliability of the Turkish Version of Telehealth Satisfaction Survey (TeSS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Health, Subjective
Health Knowledge, Attitudes, Practice
Keywords: telehealth
satisfication
telerehabilitation
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: telehealth patients caregivers and health professionals who practice telehealth

Brief summary: The Turkish validity and reliability of the scale, which was created to evaluate the satisfaction of individuals, caregivers, and coordinator providing telerehabilitation services within the scope of telehealth, will be investigated.

Detailed description: The telehealth satisfaction survey (TeSS) has been developed according to expectations, taking into account a device previously used in telehealth studies in Saskatchewan. The scale was initially used as part of a national study to evaluate the use of telehealth practices in improving professional access by residents of isolated Northern First Nations communities.The scale designed for telehealth services has been developed in English. Validity and reliability studies have been carried out by being translated into various languages. The Turkish validity and reliability study of the scale, originally in English, has not been conducted before.

Eligibility criteria: Inclusion Criteria:

* Men and woman who used telehealth

Exclusion Criteria:

* Individuals who have the poor cooperation Mini-Mental State Exam scores of under 23

Primary outcomes:
measure: Turkish Reliability and Validity of TESS (telehealth Satisfaction Survey) for patients, caregivers and health professional who use telehealth
timeFrame: March 2021-April 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University
state: Merkez
Study officials:
affiliation: Mustafa Kemal University
name: Irem Huzmeli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06332599: Minocycline for Helicobacter Pylori Rescue Treatment
Official title: Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Real-world Evidence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
rescue therapy
minocycline
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 823
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who failed at least two courses of H. pylori treatment containing clarithromycin, nitroimidazoles, fluoroquinolones, and/or amoxicillin, and received 14-day tetracycline/minocycline, metronidazole-containing bismuth quadruple therapy were identified. Patients with the following criteria were excluded: (1) naive to H. pylori treatment; (2) under 18 or over 80 years; (3) history of gastrectomy; (4) administration of antibiotics, bismuth, acid suppressants, or Chinese herb medicine in the preceding 12 weeks; (5) severe systemic diseases or malignancy.

Brief summary: Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.


Eligibility criteria: Inclusion Criteria:

* Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria:

* subjects naive to H. pylori treatment,
* history of gastrectomy
* pregnant or lactating women
* severe systemic diseases or malignancy
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 12 weeks

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within six weeks after completion of therapy
measure: Compliance rate
timeFrame: Within six weeks after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: None Selected
Study officials:
References: