louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03908216: Evaluation of Non-pharmacological and Pharmacological Treatment for oVerweight and Obesity in pAtients of the Outpatient Register (EVA)
Official title: Evaluation of Non-pharmacological and Pharmacological Treatment for Overweight and Obesity in Patients With Cardiovascular Diseases or With High Cardiovascular Risk According to the Results of Patients' Interviews Within the Outpatient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Keywords: overweight,obesity,patients' survey,drug&non-drug treatment
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2019-04-09
Enrollment: 295
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 overweight or obesity and with CVD or with a high risk of CVD

Brief summary: A prospective non-interventional single-centre study aimed to assess the current practice of non-pharmacological treatment and pharmacological therapy of overweight and obesity in patients with cardiovascular diseases (CVD) or with a high risk of CVD according to the patients' survey data

Detailed description: To interview 300 patients with a body mass index (BMI) ≥25 kg / m² of the outpatient register, who come for a primary or secondary visit to the Center. The specifically designed questionnaire contains topics about patients' self-concept of their body mass; doctors' prescriptions of therapy for obesity, patients' adherence to recommendations.

A repeated short telephone interview of these patients will be conducted in 1-1.5 years after visit inclusion to clarify the dynamics of weight and methods of its correction.

Eligibility criteria: Inclusion Criteria:

patients of the outpatient "PROFILE" registry with CVD or with a high risk of CVD (≥5%), with overweight (BMI≥25 kg/m2) or obesity (BMI≥30 kg/m2). Presence of written informed consent to participate in the study, fill in the original questionnaire and given consent to the processing of personal data

Exclusion Criteria:

normal weight, pregnancy

Primary outcomes:
measure: The proportion of patients received non-pharmacological treatment recommendations
timeFrame: on enrollment
measure: The proportion of patients received pharmacological treatment recommendations
timeFrame: on enrollment
measure: Patients' self-concept of their body mass
timeFrame: on enrollment
Secondary outcomes:
measure: Effect of overweight and obesity treatment
timeFrame: April, 2019 - November, 2020
measure: Patient self-assessment of previous overweight and obesity treatments effectiveness
timeFrame: April, 2019 - November, 2020
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Yulia Lukina
Study officials:
affiliation: National Research Center for Preventive Medicine, Moscow, Russia, 101990
name: Sergey Yu Martsevich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01696916: Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV
Official title: Development of the Partial Pressure of Carbon Dioxide During 6-min Walking Test and at Night in Patients With Chronic Obstructive Pulmonary Disease IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
carbon dioxide
6-minute walking test
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the development of partial pressure of carbon dioxide during the 6-min walking test and during night in Chronic Obstructive Pulmonary Disease (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide, oxygen saturation and the heart rate are registered by a device called "Sentec" during the mentioned periods. In addition a measurement of activity is realised by an activity monitor ("Sensewear").


Eligibility criteria: Inclusion Criteria:

* COPD IV with and without a respiratory insufficiency
* maximal paCO² of 55mmHg at admission (taken at rest by blood gas analysis without LTOT)

Exclusion Criteria:

* paCO² \> 55mmHg
* non-invasive ventilation
* acute exacerbation

Primary outcomes:
measure: Increase of PaCO2 more than 5mmHg
timeFrame: From time of starting 6-minute walking test until the time of PaCO2-increase of more than 5mmHg assessed up to 6 minutes.
Secondary outcomes:
measure: Change of PaCO2
timeFrame: From the beginning of the 6-minute walking test until peak PaCO2, assessed up to 6 minutes
Other outcomes:
Locations:
city: Berchtesgaden
country: Germany
facility: Klinikum Berchtesgadener Land
Study officials:
affiliation: Klinikum Berchtesgadener Land, Schön Klinik
name: Klaus Kenn, Dr. med.
role: STUDY_CHAIR
References:
Clinical trial NCT03735316: Vitamin B12a Vasoplegic Syndrome
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study for High-Dose Hydroxocobalamin (Vitamin B12A) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vasoplegic Syndrome
Keywords: Vitamin B12a
Hypotension
Cardiopulmonary Bypass
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low blood pressure after cardiac surgery.

Detailed description: If subjects meet the criteria for inclusion in the study based on the subjects blood pressure the subject will be randomized to receive the study drug or a placebo. Subjects blood pressure will be monitored closely for the first 30 minutes and then have standard intensive care unit (ICU) care afterwards. Kidney dysfunction will be assessed for changes in urine production and laboratory values that are followed as a part of standard postoperative care. Study coordinators will obtain these values from subjects medical records for 7 days and subjects will be contacted by phone for follow up after 30 days.

Eligibility criteria: Inclusion Criteria:

* Any patient for whom we are able to obtain consent ahead of their procedure
* Patients presenting for a procedure in which cardiopulmonary bypass will be required
* Considered high risk for vasoplegic syndrome
* Has no contraindications to arterial line or PA catheter placement
* Develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary bypass.

Exclusion Criteria:

* Age\<18 years
* Known pregnancy or patients without a documented pregnancy test if not menopausal.
* Known prior anaphylactic or allergic reaction to B12a
* CKD stage 4 or worse
* ECMO (extracorporeal membrane oxygenation) prior to study consent.
* Patients currently on cardiopulmonary bypass

Primary outcomes:
measure: Change in Mean Arterial Pressure
timeFrame: baseline, 4 hours
Secondary outcomes:
measure: Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol
timeFrame: baseline, 4 hours
measure: Change in Systolic Blood Pressure
timeFrame: baseline, 4 hours
measure: Death
timeFrame: 30 days
measure: Duration of Hospital Stay
timeFrame: 30 days
measure: Duration of Intensive Care Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Saint Mary's Hospital
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James A. Nelson, M.B.B.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00677924: Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer
Official title: A Dose-Escalation, Randomized Phase I/II Trial of Zalutumumab - a Human Monoclonal Anti-EGF Receptor Antibody - With or Without Irinotecan Chemotherapy in Cetuximab Refractory Colorectal Cancer Patients Who Have Failed Standard Chemotherapy and Progressed During or Within 3 Months of Stopping Cetuximab-Based Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Keywords: Colorectal Neoplasms
Colorectal Tumors
Colorectal Carcinoma
Lead sponsor: Genmab
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 9
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: The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer


Eligibility criteria: Inclusion Criteria:

1. Males and Females age ≥ 18 years
2. Confirmed diagnosis of CRC
3. Documented disease progression
4. Failure and/or intolerance to standard chemotherapy

Exclusion Criteria:

1. Prior treatment with anti-EGFR antibodies other than cetuximab
2. Expected survival \< 3 months
3. Clinical significant cardiac disease and/or uncontrolled medical conditions

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose up to follow-up (up to approximately 1 year)
Secondary outcomes:
measure: Number of Participants With Best Overall Tumour Response (BOR)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Hospital Erasme
city: Brussels
country: Belgium
facility: St-Luc University Hospital
Study officials:
affiliation: Genmab
name: Hassan Aladdin, ICTM
role: STUDY_DIRECTOR
References:
citation: Mano M, Hendlisz A, Machiels JP, Ehrnrooth E, Aladdin H, Van Laethem JL. Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan and cetuximab based therapy. J Clin Oncol 27 2009 (suppl;abstr e15028)
Clinical trial NCT04161924: Utilization of Simulated Grid (SimGrid™) Technology for the Reduction of Ionizing Radiation Dose on X-ray Examination in Obese Patients
Official title: Utilization of Simulated Grid (SimGrid™) Technology for the Reduction of Ionizing Radiation Dose on X-ray Examination in Obese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2019-11-13
Enrollment: 34
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: Adult patients at clinic who needed chest radiography for continuation of care.

Brief summary: The purpose of this research study is to learn if a new imaging processing technique called Simulated grid (SimGrid™) will help in getting better quality X-ray images in obese subjects. The GM85 digital radiography machine will be used to obtain X-ray images.


Eligibility criteria: Inclusion Criteria:

* Obese adult volunteers with Body-Mass Index (BMI) exceeding 30
* subjects that require at least one X-ray for continuation of care

Exclusion Criteria:

* subject who is known to have lung disease(s) which would interfere with the interpretation of the chest radiography image
* subject who is pregnant or breastfeeding

Primary outcomes:
measure: Image quality of conventional grid versus SimGrid using 5 point Likert scale
timeFrame: baseline
measure: Image quality of non-grid versus SimGrid using 5 point Likert scale
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Roy F Riascos-Castaneda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00891124: Effect of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).
Official title: A Multi-center, Prospective, Observational Study to Assess the Effect of Patient Education Related to CV Risk Factors in Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glycemia
Hypertension
Hyperlipidemia
Keywords: Hypertension
Type II DM
Hyperlipidemia
Glycemia
ADA 2008 guideline
Patient Consultation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 4045
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: Type II DM and Hypertension and/or Hyperlipidemia

Brief summary: This study will address the proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline, among outpatients coming to the Korean primary care nationwide.


Eligibility criteria: Inclusion Criteria:

* Patients who had been diagnosed with type II diabetes mellitus
* Patients with hypertension and / or hyperlipidemia
* Patients who had agreed to Informed

Exclusion Criteria:

* Patients who had been diagnosed with type I diabetes mellitus
* Patients with neither hypertension and hyperlipidemia

Primary outcomes:
measure: Proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline
timeFrame: At baseline and Endpiont (after 2months)
Secondary outcomes:
measure: The treatment goal of risk factors is based on ADA guideline.
timeFrame: At baseline and Endpiont (after 2months)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Cheiju
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research SIte
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Hongsung
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Sungman
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: ASTRAZENECA, Korea Medical Department
name: Joonwoo Bahn
role: STUDY_DIRECTOR
References:
Clinical trial NCT01027624: Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia
Official title: Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undertreatment of Hypercholesterolaemia
Keywords: Pan South African Survey on the Undertreatment of Hypercholesterolaemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-12-08
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multi-centre survey of patients who are currently on lipid-lowering pharmacological treatment in South Africa.

Brief summary: This is a multi-centre survey of patients who are currently on lipid lowering pharmacological treatment in South Africa.


Eligibility criteria: Inclusion Criteria:

* Subject must be 18 years of age or older of either gender or race.
* Subject must provide informed consent and comply with the survey procedures.
* Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.

Primary outcomes:
measure: Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III
Secondary outcomes:
measure: Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III
measure: Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to the Fourth Joint European Task Force Guidelines/South African Guidelines in primary/secondary prevention patients, patients with metabolic syndrome
measure: Proportion of patients on lipid-lowering pharmacological treatment reaching the non HDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III Guidelines
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Research Site
Study officials:
affiliation: National Co-ordinator
name: Prof F Raal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04951024: Thoracolumbal Interfascial Plane Block Versus Erector Spinae Plane Block for Lumbar Posterior Decompression Stabilization
Official title: Comparison of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block With Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization: A Study to Interleukin-6 and Interleukin-10 Plasma Concentration, Pain Scale, Total Opioid Consumption, and Cardiovascular Stability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Posterior Decompression
Keywords: Thoracolumbal Interfascial Plane Block
Erector Spinae Plane Block
Lumbar Posterior Decompression and Stabilization
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to found out The Comparison Of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block with Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization.

Detailed description: This is a double blind randomized controlled trial. Forty subject will be recruited with non-probability consecutive sampling method. Subjects who meet all inclusion criteria and do not have exclusion criteria will be asked to sign the informed consent form before included in this study. Subjects will be randomized into two groups. The first group is the group who will get Bilateral Thoracolumbal Interfascial Plane Block after general anesthesia and the second group will be the group who will get Bilateral Erector Spinae Plane Block after general anesthesia. After surgery, pain scale, time to first morphine dose, total morphine consumption in 24 hours, cardiovascular stability and adverse events will be recorded for both group.

Eligibility criteria: Inclusion Criteria:

1. Age 18 - 65 years old
2. Patients schedule for elective posterior decompression and stabilization lumbar spine surgery
3. ASA I - III
4. Decompression and posterior stabilization's patients who didn't caused by infection or abscess

Exclusion Criteria:

1. Patients who refuse to participate in this study
2. Body Mass Index \< 18,5 kg/m2 and \> 27,0 kg/m2
3. Patient with history of chronic opioid
4. Patient with coagulation disorder
5. Patient with cognitive disorders
6. Infection at the injection area

Primary outcomes:
measure: Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization
timeFrame: Before surgery and 6 hours after surgery
Secondary outcomes:
measure: investigators will record total morphine dose needed in 24 hours
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT05940324: Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
Official title: Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Ketamine
Naltrexone
MRI
Brain Imaging
OCD symptoms
Obsessive-Compulsive Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized with a 1:1 allocation to either IV ketamine + oral placebo or IV ketamine + oral opioid antagonist naltrexone
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand how ketamine works in the brain to bring about a reduction in OCD symptoms.

Detailed description: The proposed mechanistic trial would be the first to probe the role of ketamine's opioid properties in modulating fronto-striatal circuitry and bringing about reduction of OCD symptoms.

Eligibility criteria: Eligibility Criteria for Participants with OCD:

Inclusion Criteria:

* Ages 18-65
* Meet the criteria for OCD diagnosis
* Failed at least 1 prior trial of standard first-line OCD treatment
* Agree to the following lifestyle modifications: comply with requirements for fasting prior to the Experimental Session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication study procedures.
* Able to provide informed consent

Exclusion Criteria:

* prior naltrexone or ketamine use/exposure
* Any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
* Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
* the presence of metal in the body that is contraindicated for MRI scans

Eligibility Criteria for Healthy Volunteers:

Inclusion Criteria:

* Ages 18-65
* Able to provide informed consent

Exclusion Criteria:

* current or past use of psychotropic medication
* pregnant or nursing females
* the presence of metal in the body that is contraindicated for MRI scans

Primary outcomes:
measure: Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Baseline (Visit 2) to Post Infusion fMRI scan (Visit 4; Day 1), up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Department of Psychiatry & Behavioral Sciences
state: California
Study officials:
References: