louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06414811: Tapse/Pasp General Anesthesia
Official title: Prediction of TAPSE/PASP Ratio for Hypotension Due to General Anesthesia Induction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypotension
Keywords: TAPSE
PASP
GENERAL ANESTHESİA
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA1-3 patients aged 18-75 who will undergo elective surgery

Brief summary: TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

Detailed description: TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

Patients will be measured by transthoracic echocardiography in the preoperative period, 15-30 minutes before induction.

Basal hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until surgical incision.Patients with a 30% decrease in SBP from the baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. Patients will be divided into 2 groups: 'with' and 'without' hypotension.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent;
2. 18-75 years old
3. ASA Physical Status 1-3;
4. Patients planned for surgery

Exclusion Criteria:

1. The patient is pregnant
2. After cardiac surgery
3. Severe pulmonary hypertension
4. Severe valve disease
5. Hypertrophic or dilated cardiomyopathy
6. Presence of acute myocardial infarction
7. Patients with severe visual or hearing impairment/disability
8. ASA physical status IV or V
9. Ischemic heart disease, conduction disorder.

Primary outcomes:
measure: 1. tension
timeFrame: 4-5 hours]
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Ferdi Gülaştı
Study officials:
References:
Clinical trial NCT06773611: Electronic Register on Advanced Heart Failure and Transplantation di Cuore
Official title: Electronic Register on Advanced Heart Failure and Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Heart Transplantation
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients attending the SSD Heart Failure and Transplants unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna will be evaluated, starting from 01/01/1985. Each patient has been and will be followed according to standard care practices.

Brief summary: The goal of this observational study is to create an electronic registry of patients diagnosed with Advanced Heart Failure or Heart Transplant, starting from 01/01/1985 and to assess the incidence of Advanced Heart Failure and Heart Transplant, and characterize patients affected by the first or undergoing the second procedure, starting from 01/01/1985. The primary outcomes are:

* Hospitalization for cardiovascular cause
* Death

Detailed description: Heart failure is a pathological condition characterized by high morbidity and mortality, and it leads to a significant worsening of the quality of life for patients. The treatment of heart failure involves various options; the goal is to slow down the progression of the disease, reduce hospitalizations, increase survival, and reduce symptoms in order to improve the quality of life. Treatments range from pharmacological therapy to lifestyle changes, from device implantation to heart transplant surgery. Early diagnosis and treatment often help reduce symptoms, and many patients with heart failure can return to an active life. Patients with heart failure must undergo regular check-ups to assess their general physical condition and the status of the disease. It is therefore essential to evaluate and systematize the different therapies.

This study is both retrospective and prospective

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Ability to provide informed consent
* Diagnosis of Advanced Heart Failure or Heart Transplant

Exclusion Criteria:

* none

Primary outcomes:
measure: Hospitalization for cardiovascular cause
timeFrame: 5 years
measure: Death
timeFrame: 5 years
Secondary outcomes:
measure: Hospitalization for non-cardiovascular cause
timeFrame: 5 years
measure: Implantation of medical device (including mechanical support)
timeFrame: 5 years
measure: Need for intravenous diuretic therapy
timeFrame: 5 years
measure: Need for hemodialysis event
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Luciano G Potena, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00529711: The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Official title: The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Cardiac Output
Keywords: coronary
artery
bypass
grafting
IV
cardiac output
Lead sponsor: Innogene Kalbiotech Pte. Ltd
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 66
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach circulation volume, as compared to Sodium Chloride.It also does not cause hyperchloremic acidosis, which is of value in treating shock patients.

The primary objectives of this prospective, randomized, open-label trial are to evaluate the clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence of adverse events.The secondary objectives are to evaluate comparative clinical efficacy of the two fluids in relation to reduction in concomitant drug utilization, duration of ventilator usage, length of stay in ICU as well as total duration of hospitalization and neurocognitive status upto a period of 1 year post-CABG.

Detailed description: Details provided in summary.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 45 to 80 years
* CABG patients with on or off pump procedure
* Ejection fraction \< 50%
* Given informed consent

Exclusion Criteria:

* Combined operations
* Severe arrhythmia(VT, AF rapid response, heart blocks) and severe hemodynamic imbalance
* Severe bleeding and/or re-operation
* Hypernatremia \> 155 mMol/L
* Severe liver failure(SGOT, SGPT 2x normal)
* Severe renal failure(Creatinine \> 2 mg. %)
* Major diseases(eg. cancer)

Primary outcomes:
measure: Hemodynamic status
timeFrame: During and 12 hours after CABG surgery
Secondary outcomes:
measure: Safety of hypertonic sodium lactate for maintaining hemodynamic stability
timeFrame: During and 12 hours after CABG surgery
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital
Study officials:
affiliation: Director, INSERM-E0221-Bioenergetique Fondamentale et appliquee, Universite Joseph Fourier, France
name: Xavier Leverve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01925911: Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam
Official title: A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of IPI-145 on Single-Dose Pharmacokinetics of Midazolam (a CYP3A Substrate) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Healthy subjects
DDI
CYP3A
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2013-08-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with midazolam in healthy subjects.

Detailed description: * In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.
* In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID) oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg IPI-145 concomitantly administered with 2 mg of midazolam.

Eligibility criteria: Inclusion Criteria:

* Healthy men or women of non-childbearing potential between 18-50 years of age
* Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
* In good health, determined by no clinically significant findings from clinical evaluations
* Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

* Women of childbearing potential
* Evidence of clinically significant medical conditions
* History of gastrointestinal disease or surgery that may affect drug absorption
* Positive or indeterminate tuberculosis-spot test at screening
* Any active infection at the time of screening or admission
* Subjects with acute narrow-angle glaucoma

Primary outcomes:
measure: Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam
timeFrame: Over 24 hours
measure: Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam
timeFrame: Over 24 hours
measure: Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam
timeFrame: Over 24 hours
measure: Plasma concentrations of midazolam and 1-hydroxy-midazolam
timeFrame: Over 24 hours
Secondary outcomes:
measure: Incidence of adverse events following of administration midazolam, IPI-145 and the combination
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA International
state: Kansas
Study officials:
affiliation: Verastem, Inc.
name: Hagop Youssoufian, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04691011: New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
Official title: New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 3 groups :

* muscle
* brain
* spinal cord
Primary purpose: DIAGNOSTIC

Brief summary: Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Our project aims to find new biomarkers in MRI at three levels: cerebral, medullary and muscular. These markers could allow an earlier diagnosis of the disease by showing more specific lesions of ALS and to quantify these lesions to measure the progression of the disease. This study will use advanced Magnetic Resonance Imaging (MRI) techniques High field (3T) and very high field (7T) MRI. Results from neurological and electrophysiological tests will be compared to the MRI. Subjects will be recruited from ALS center of Marseille, France. MRI will be done on ALS patients at baseline, at 3 month and at 6 month intervals.


Eligibility criteria: Inclusion Criteria:

* Patients will be adults with a diagnosis of ALS.
* Healthy controls will also be recruited and will be age- and gender-matched to patients.
* Patients able to undergo a brain MRI for approximately an hour.

Exclusion Criteria:

* Subjects with other psychiatric or CNS or PNS diseases.
* Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body, or significant claustrophobia that could affect the ability to have an MRI scan.

Primary outcomes:
measure: Disease progression using MRI
timeFrame: Change from Baseline and at Month 6
Secondary outcomes:
measure: Link between MRI and clinical scales
timeFrame: Baseline and Month 6
measure: Link between MRI and MUNIX
timeFrame: Baseline and Month 6
measure: Alterations of metabolic and funtional brain
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Marseille
country: France
facility: Shahram Attarian
Study officials:
affiliation: Direction Recherche Santé APHM
name: Emilie Garrido Pradalié
role: STUDY_DIRECTOR
References:
Clinical trial NCT05863611: The Impact of Frailty in Type 2 Diabetes
Official title: The Effect of Frailty on Balance and Fall Risk in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: be diagnosed with type 2 diabetes be over 65 years old

Brief summary: The purpose of our work; To investigate the effect of frailty on balance and fall risk in individuals with type 2 diabetes.The reason why participants the investigators invited to the study is participants diagnosis of Type 2 Diabetes.During the research, a questionnaire form (age, gender, educational status, etc.) in which participants demographic information will be recorded for evaluation purposes and a consent form for participation in the study will be filled. Standardized Mini Mental Test will be applied. Then fragility will be evaluated with the Fried Fragility Index. Fall assessment will be assessed with the Fall Risk Self-Assessment Scale and balance assessment will be made with the Tinetti Balance. participants will not need to spend a long time for all assessments. The time required for the assessment will be around 30 minutes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with diabetes
* Being 65 years or older
* Not having a cooperation problem,
* No communication difficulties or problems voluntarily accepting participation in the research

Exclusion Criteria:

* - Those with uncontrollable hypertension, heart disease, cardiac arrhythmia
* Those with cardiovascular disease
* Those who have malignancy and cause malignancy, chemotherapy, radiotherapy
* Those with any neurological or orthopedic disorders
* Those who have had an operation in the last 6 months
* Those on bed rest
* Individuals addicted to alcohol and drugs
* Those who do not agree to participate in the research

Primary outcomes:
measure: Frailty has an effect on balance in patients with type 2 diabetes.
timeFrame: march 15, 2023 - june 10 , 2023
Secondary outcomes:
measure: Frailty has an effect on the risk of falling in patients with type 2 diabetes.
timeFrame: march 15, 2023 - june 10 , 2023
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Gulsah Turanoglu
state: Merkez
Study officials:
References:
Clinical trial NCT00521911: Detection and Treatment of Depression in Patients Admitted to the General Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depressive Disorder
Depression
Keywords: Intervention Studies
Randomized Controlled Trials
Cognitive Therapy
Hospitals, General
Prevalence
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2007-08-28
Enrollment: 60
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: Depression is a common disorder among patients with a somatic illness admitted to the general hospital. Patients with depression do worse in terms of their somatic symptoms or functioning that those without depression. They also stay in the hospital for longer.

That is the reason that we are interested to know whether patients with depression do better if their depression is recognised earlier and treated appropriately. We would like to find out which questionnaires are most suitable in clinical practice to help pick up patients with a depression. In addition, we would like to know whether a short-term psychological treatment of depression would be of any help. We hope to be able to show that this treatment would not only result in a reduction of depressive symptoms, but also in a better and quicker recovery of the somatic illness.

The treatment will consist of 6 to 9 weekly sessions of one hour, conducted by a cognitive behavioural assistant. Initially, the treatment will take place in the hospital. When patients are discharged, treatment sessions will continue at home. The treatment will focus on things like recognising and challenging unhelpful thoughts, planning of activities, and testing out of predictions by setting up behavioural experiments. Three monthly booster sessions will be offered to help patients to maintain their gains and prevent relapse. We will reassess the symptoms of the patients at three and six months after the end of treatment.


Eligibility criteria: Inclusion Criteria:

* Depressive Disorder

Exclusion Criteria:

* Severe Physical Disfunction
* Severe Cognitive Disfunction
* Speech and/or Hearing Disorder
* Limited knowledge of the Dutch language

Primary outcomes:
measure: Depressive Disorder Physical symptoms
timeFrame: 9 months
Secondary outcomes:
measure: - Functional impairment (RAND 36) - Cost-effectiveness (TiC-P) - Quality of Life (EQ5D)
timeFrame: 9 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Anne EM Speckens, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04789811: Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps
Official title: The Effectiveness of Exercise and Dry Needling Treatment Combination in Patients With Nocturnal Calf Cramps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nocturnal Leg Cramps
Myofascial Pain Syndrome
Keywords: Dry needling
Calf cramp
Myofascial trigger point
Lead sponsor: Kars State Hospital
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 50
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised controlled
Primary purpose: TREATMENT

Brief summary: The Investigators aim to evaluate the effectiveness of dry needling treatment in addition to stretching exercises on cramp duration, cramp intensity, cramp frequency, sleep quality, and sensitivity of myofascial trigger points in patients with nocturnal calf cramp.

Detailed description: Nocturnal leg cramps are sudden, involuntary, painful contractions of the lower extremity in the nighttime, most often in the calf muscles, that gradually lessens. Its etiology is not clear. It can be seen in electrolyte disturbances, drug side effects, neuromuscular diseases, diabetes mellitus, peripheral vascular pathologies. It has been mentioned in the literature that myofascial trigger points in the gastrocnemius muscle may be associated with nocturnal calf cramps. Our aim in this study is to evaluate the effectiveness of the combination of stretching exercises and dry needling therapy on cramp duration, cramp intensity, cramp frequency, sleep quality, and algometer measurement in patients with nocturnal calf cramps and whose had myofascial trigger point in the gastrocnemius muscle.

Eligibility criteria: Inclusion Criteria:

* Patients with only nocturnal calf cramp
* Patients with a trigger point in the unilateral gastrocnemius muscle
* Being between the ages of 18-50

Exclusion Criteria:

* Patients using diuretics or hypertension medications that may trigger cramping
* Those with a chronic disease history
* Those diagnosed with spinal stenosis
* Electrolyte disturbance in laboratory tests

Primary outcomes:
measure: Change in calf cramp duration
timeFrame: 3 months
measure: Change in Number of Cramps
timeFrame: 3 months
measure: Change in cramp intensity levels with visual analog scale
timeFrame: 3 months
measure: Change in algometric sensitivity measurement
timeFrame: 3 months
measure: Change in sleep quality
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Kars State Hospital
Study officials:
affiliation: Kars State Hospital
name: Fatih Bagcier, M.D.
role: PRINCIPAL_INVESTIGATOR
References: