louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04518761: Predictive Modelling of the Intraoperative Train-of-Four (TOF) Ratio
Official title: Predictive Modelling of the Intraoperative Train-of-Four (TOF) Ratio
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Analyse Neuromuscular Monitoring for Developing a Model to Predict TOF Ratio During Anesthesia
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (18 years old and above) receiving General Anesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent.

Brief summary: Neuromuscular Blocking Agents (NMBAs) are routinely administered to patients in a multiplicity o anaesthetic settings in order to paralyze and impede (re)active muscular contraction. The availability of monitoring devices allowing an accurate measurement fo the degree of neuromuscular block during anesthesia has raised the standards for a proper evidence-based use of NMBAs.

For this purpose, one of the most widely used methods is the Train of Four (TOF): transcutaneous application of a series of 4 square-wave supra-maximal electrical stimuli over the course of a nerve of choice (most commonly the ulnar nerve). These are applied at a frequency of 2Hz, and each with a duration of 0.2ms. These stimuli elicit a motor response on the adductor pollicis muscle, which on its turn dictates the adduction of the thumb. The acceleration of this movement can be followed by means of an uni/multi-directional accelerometer attached to the thumb. The ratio of the acceleration of the 4th and 1st elicited contractions is called the TOF-Ratio - a clinically and scientifically established method of assessing neuromuscular block recovery. A value of 1 translates a full recovery of the muscular function of a patient. In modern Anesthesia, the bar for deeming a recovery as adequate has been set at a minimum of a TOF-ratio of \>0.9, with some authors advocating a ratio of 1 as the only acceptable and complications avoiding result.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years old and above) receiving General Anesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent.
* Administration of General Anesthesia by means of Total Intravenous Anesthesia technique.
* Use of Rocuronium as a neuromuscular blocking agent.

Exclusion Criteria:

* Use of different types of neuromuscular blocking agents for the same patient within the same surgical procedure
* Known Neuromuscular diseases/syndromes judged to condition accurate neuromuscular monitoring.

Primary outcomes:
measure: TOF-ratio
timeFrame: 1 day
Secondary outcomes:
measure: TOF-count
timeFrame: 1 day
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
city: Brugge
country: Belgium
facility: AZ Sint Jan
state: WV
Study officials:
References:
Clinical trial NCT01864161: Endovenous Versus Liposomal Iron in CKD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Chronic Kidney Disease
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 100
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: Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the prescription of iron is usually oral because of practicality and safety, but often it is inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance to oral administration, irregular intake. There're few randomized controlled studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption and high bioavailability with lower incidence of side effects. The investigators study aims to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron in CKD anemic patients not on dialysis in the presence of iron deficiency.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Signed written informed consent;
* Glomerular filtration rate (GFR) ≤ 60 mL/min (MDRD GFR calculated according to 4 variables);
* hemoglobin ≤ 12g/dL;
* Ferritin ≤ 100ng/mL with transferrin saturation (TSAT) ≤ 25%;
* If erythropoiesis stimulating agents (ESA) therapy, stable dose for at least three months;

Exclusion Criteria:

* Infectious diseases;
* bleeding in the preceding six months;
* History of malignancy tumor in the last 3 years;
* Anemia case different from that resulting from CKD;
* vitamin B12 and folate deficiency;
* Surgery of any kind in the last three months;
* systemic haematological disease;
* Blood Transfusions, therapy with intravenous or oral iron in the last three months;
* Severe liver disease / test positive for hepatitis C virus (HCV) and hepatitis B virus (HBV);
* Abuse of alcohol and drugs in the preceding six months;
* immunosuppressive therapy ;
* Significant weight loss;
* Pregnancy or breast-feeding.

Primary outcomes:
measure: modification in hemoglobin levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University
Study officials:
References:
Clinical trial NCT04526561: Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales
Official title: Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2020-08-26
Enrollment: 550
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts.

1. Validation of scales/instrument for Swedish.
2. Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up.
3. Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction.
4. TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.


Eligibility criteria: Inclusion criteria:

* Patients eligible for breast reconstruction following mastectomy and radiation
* Non-smokers or ex-smokers (\>6 weeks)
* BMI \< 30

Exclusion Criteria:

* Inability to leave informed consent
* Inability to understand Swedish
* Previous surgery with scaring on back

Primary outcomes:
measure: Patient satisfaction and breast-related quality of life after breast reconstruction
timeFrame: 10 years
measure: Back and shoulder function after breast reconstruction
timeFrame: 10 years
measure: Back appearance after breast reconstruction
timeFrame: 10 years
measure: Shoulder function after breast reconstruction
timeFrame: 10 years
measure: Abdominal satisfaction after breast reconstruction
timeFrame: 10 years
Secondary outcomes:
measure: Complications after breast reconstruction
timeFrame: 2 years
Other outcomes:
measure: Validation of Breast Q: The Back Appearance scale for Swedish
timeFrame: 1 year
measure: Validation of Breast-Q: The back and shoulder function scale for Swedish
timeFrame: 1 year
measure: Normal material for Breast-Q
timeFrame: 5 years
measure: Normal material for Breast-Q back appearance scale
timeFrame: 5 years
measure: Normal material for Breast-Q back and shoulder function scale
timeFrame: 5 years
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
References:
citation: Kamya L, Hansson E, Weick L, Hansson E. Validation and reliability testing of the Breast-Q latissimus dorsi questionnaire: cross-cultural adaptation and psychometric properties in a Swedish population. Health Qual Life Outcomes. 2021 Jul 3;19(1):174. doi: 10.1186/s12955-021-01812-x.
Clinical trial NCT06141161: Assessment of Bronchial Asthma Among Patients Attending Sohag University Hospital
Official title: Assessment of Bronchial Asthma Among Patients Attending Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchial Asthma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 200
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: bronchial asthma patients aged more than 18 years of both sexes

Brief summary: Asthma is a significant public health threat, affecting more than 300 million individuals globally. Asthma is classified as a non-communicable disease and leads to reduced quality of life, poor physical functioning and reduced emotional well-being. The impact of this disease can be widespread and extends beyond the person living with the disease, affecting the lives of their family members, carers, communities and the health care system (1).

Asthma is a variable chronic respiratory condition. It is characterized by symptoms of wheeze, cough, chest tightness, dyspnea and backed by variable airflow limitation, airway inflammation and airway hyper-responsiveness (AHR). The severity of asthma varies considerably, both between individuals and within individuals over time. Some people may have intermittent asthma and others may experience severe, potentially life-threatening disease (2, 3,4).


Eligibility criteria: Inclusion Criteria:

* bronchial asthma patients aged more than 18 years, both sexes are included

Exclusion Criteria:

* children ,patients who are unable to do spiromerty or contrindecated

Primary outcomes:
measure: percent of controlled bronchial asthma patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: Dashash NA, Mukhtar SH. Prescribing for asthmatic children in primary care. Are we following guidelines? Saudi Med J. 2003 May;24(5):507-11.
citation: Al-Moamary MS, Alhaider SA, Al-Hajjaj MS, Al-Ghobain MO, Idrees MM, Zeitouni MO, Al-Harbi AS, Al Dabbagh MM, Al-Matar H, Alorainy HS. The Saudi initiative for asthma - 2012 update: Guidelines for the diagnosis and management of asthma in adults and children. Ann Thorac Med. 2012 Oct;7(4):175-204. doi: 10.4103/1817-1737.102166.
citation: Braido F, Canonica GW. Worldwide differences on the concept of control of asthma. Ther Adv Respir Dis. 2008 Feb;2(1):3-5. doi: 10.1177/1753465807087091.
citation: National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
Clinical trial NCT00825461: Ghrelin With Anorexia Nervosa
Official title: Level of Ghrelin With Anorexia Nervosa (AN) Patients. Subgroup AN: With and Without Tubefeeding.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Studypopulation: Patiënts: all female, non -age coupled. Subgroup patients without tube feeding, with tube feeding and a healthy matched control group.

Control group: healthy volunteers of the University of Maastricht.

Brief summary: The PICOWO research group in corporation with the University of Amsterdam (Artificial Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos, Jonker \& Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea for this current research is to collect clinical information about the functioning and (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.

Detailed description: Eating disorders are in need of new perspectives. A better understanding of the appetite in patients with eating disorders, especially Anorexia Nervosa, could be investigated by the levels of ghrelin in patients with and without tube feeding.

Eligibility criteria: Inclusion Criteria:

* Studypopulation: Patiënts: all female, non -age coupled.
* Subgroup patients without tube feeding, with tube feeding and a healthy matched control group.
* Control group: healty volunteers of the University of Maastricht.

Exclusion Criteria:

* Patients with a history of eating disorder different than AN or a psychiatric history.
* Control group: no history of eating disorders or other psychiatric disabilities. Normal physical examination, ecg, laboratorium (blood cells, liver, kidneys)

Primary outcomes:
measure: Concentration of ghrelin in blood.
timeFrame: 1 morning
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
state: Limburg
Study officials:
affiliation: PICOWO Utrecht
name: Martine F Delfos, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosse, T.; Delfos., M.F.; Jonker, C.M. & Treur, J. (2003). Reasoning about adaptive Dynamical Systems in the Analysis of eating Regulation Disorders. N.J. Mahwah. Proceedings of the 25th Annual Conference of the Cognitive Science Society. Lawrence Erlbaum Associates Inc.
citation: Both, F. & Delfos, M.F. (in preparation). The role of ghrelin in eating disorders, a review.
Clinical trial NCT01332383: Special Drug Use Investigation for AMERGE® Tablet (Long-term)
Official title: Special Drug Use Investigation for AMERGE Tablet (Long-term)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with migraine headache who are naive to AMERGE

Brief summary: To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting


Eligibility criteria: Inclusion Criteria:

* Must use AMERGE for the first time

Exclusion Criteria:

* Patients with hypersensitivity to naratriptan or any of the components.
* Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
* Patients with history of cerebral vascular disturbance or transient ischaemic attack
* Patients with peripheral vascular syndromes
* Patients with uncontrolled hypertension
* Patients with severe renal or hepatic impairment
* Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication

Primary outcomes:
measure: The number of adverse drug reactions and serious adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05550883: Aerobic Exercise for Women With Fibromyalgia
Official title: Effectiveness of Aerobic Exercises for Women With Fibromyalgia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is randomized controlled trial that investigated the effect of aerobic exercises in women with fibromyalgia. The study was performed in Abu-kabir central hospital - Al Sharquia, Egypt. The sample was recruited from the rheumatology department in Abu-kabir central hospital- Al Sharquia. Sixty women were included in the study based on the inclusion criteria. The first group (study group) included 30 participants who received aerobic exercise in addition to the prescribed medications. The second group (control group) included 30 participants who received the prescribed medications only. The outcome measures included visual analogue scale, Fibromyalgia Impact Questionnaire and cholesterol level. Assessment of outcomes were performed at baseline and after the end of treatment program.


Eligibility criteria: Inclusion Criteria:

* (1)Their ages ranged from 30 to 40 years old (2)Their body mass index (BMI) was from 20:26 kg/m2 (3)All patients assured diagnosis fibromyalgia for more than three months (4)Participants were on a stable regimen of pharmacological and/or non pharmacological treatment for FM the previous three months leading up to study period and agree to maintain their present medication unchanged for the duration of their participation in the study

Exclusion Criteria:

Patients with pregnancy, another accompanying central sensitization syndrome Patients with psychiatric illness Patients whose pharmacological treatment for FMS changed within the last three months Patients who do not have a cognitive level to answer the questions in the scale

Primary outcomes:
measure: Changes in Visual analogue scale
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Changes in cholesterol level level
timeFrame: baseline and 6 weeks
measure: Changes in Fibromyalgia Impact Questionnaire
timeFrame: baseline and 6 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Abu-kabir central hosptial
state: Al Sharquia
Study officials:
affiliation: Cairo University
name: Heba Abdeen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04609683: Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure
Official title: Introductory Non-Clinical and Clinical Trial for Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Subjects will be consented to wear the AleriTM sensor prior to, during, and after an Electrophysiology Procedure. During this time, the system will measure the following parameters from subjects: HR, temperature, saline volume/rate, urine production volume, USG, BPO. Data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor hydration levels of subjects compared to currently available methods.

Detailed description: Study subjects scheduled for an EP procedure who have signed an informed consent form (ICF) will be admitted to the study. Prior to the EP procedure (e.g. in a hospital room or operating room at NYU Medical Center), either an employee of NYU or Hydrostasis will place sensor on subject's bicep, forearm, or wrist, start the sensor and connect the sensor to mobile app to start data collection.

Eligibility criteria: Inclusion Criteria:

* Patients with cardiac arrhythmias or other cardiac conditions that are scheduled for EP procedures.
* Subject is over 18 years of age at the time of consenting
* Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study

Exclusion Criteria:

* Pregnant subjects
* Subjects who are participating in another clinical study that may affect the results of either study
* Subjects who are unwilling or unable to wear the sensor for a period of up to 14 hours
* Subjects who are considered by the principle investigator to be medically unsuitable for study participation

Primary outcomes:
measure: changes in body water content before, during and after an Electrophysiology Procedure
timeFrame: 1 hour pre-surgery, during surgery and 3-5 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lior Jankelson
role: PRINCIPAL_INVESTIGATOR
References: