louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02564250: Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
Official title: Healthy Mother - Lifelong Health: A Longitudinal Study on Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Obesity
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with prepregnancy BMI \> 35

Brief summary: The purpose of this study is to study longitudinal changes in maternal metabolism and pregnancy outcomes in obese pregnant women.

Detailed description: We will study how normal metabolic changes of pregnancy are modified in obesity and investigate the consequences of altered fat and carbohydrate metabolism for pregnancy outcome. The results will aid our understanding of why pregnant obese women and their babies are at higher risk of complications and may highlight potential therapies to reduce these risks.

Overall aim and hypothesis:

The overall aim is to increase knowledge about the relation between obesity, metabolic profile/risk factors and pregnancy outcome in order to improve antenatal care and the health of the next generation.

We hypothesize that obese pregnant women can be differentiated into subgroups according to their metabolic risk profile and their risk of adverse pregnancy outcomes.

Specific aims:

Establish an outpatient clinic for obese pregnant women at Department of Obstetrics, Drammen, Vestre Viken HF in order to:

* Provide improved antenatal care for obese pregnant women who have increased risk of pregnancy complications by offering:

  * antenatal care according to national guidelines (Veileder i fødselshjelp 2014)
  * fetal surveillance (ultrasound)
  * planned delivery according to national and local guidelines
* Conduct an observational study in which clinical and biochemical data will be collected in order to increase knowledge on longitudinal metabolic changes in pregnancies complicated by obesity and how these relate to pregnancy outcomes

Eligibility criteria: Inclusion Criteria:

* pregnant women with pregestational BMI \> 35

Exclusion Criteria:

* diabetes mellitus type 1

Primary outcomes:
measure: Mode of delivery
timeFrame: 3 years
Secondary outcomes:
measure: Longitudinal metabolic changes during pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust
state: Buskerud
Study officials:
affiliation: Vestre Viken HF
name: Marie Cecilie P Roland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01079650: Diagnosis of Acute Appendicitis, Ovary Torsion and Inflammation, and Testicular Torsion and Inflammation by Infrared Thermography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Pain
Testicle Pain
Keywords: children
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-03
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children (\<18 years old) having abdominal or testicle pain.

Brief summary: Thermal, or infrared, energy is the part of electromagnetic radiation that an observer perceives as heat. Infrared thermography allows us to visualize temperature distribution of the human body and has been used in medical practice since the 1950s. In current study we would like to examine the ability of infrared thermography to detect acute appendicitis, ovary torsion and inflammation, and testicular torsion and inflammation.


Eligibility criteria: Inclusion Criteria:

* \< 18 years old

Exclusion Criteria:

* \> 18 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Yaakov
country: Israel
facility: Assaf-Harofeh MC
Study officials:
References:
Clinical trial NCT01694550: QT Interval in Patients With Pacemaker Dependency
Official title: Corrected QT Interval in Patients With Pacemaker Dependency (QT-TENDENCY-Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Degree AV-block
Left Bundle Branch Block
Keywords: pacemaker
ICD / CRTD
corrected QT-interval
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll 180 patients after an implantation of cardioverter/defibrillator or pacemaker based on a standard guideline indication. The point of enrolment for all patients is the time at which the patient signs and dates the ICF during the hospital stay in the context of implantation.

Brief summary: The aim of this study is to examine a correction term for an adapted QT interval during ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting for the QT intervals in various pacing conditions.

Detailed description: This investigation aims at determining a possibility to assess the usefulness of various formulae that correct for the different effects of various pacing modes on the QT interval. More specifically, the hypothesis will be tested that applying adequate correction will preserve the predictive power of the QT-interval regarding proarrhythmia in various cardiac pathologies and therapies.

Eligibility criteria: Inclusion Criteria:

* caucasian race
* implanted cardioverter/defibrillator or pacemaker
* negative pregnancy test for women of child bearing potential
* stable function of the implanted device
* stable medical therapy relating to the underlying disease
* stable medical therapy of antiarrhythmic drugs and other QT-time changing drugs
* no instability of rhythm
* x-ray of thorax during device implantation in two levels (ap and ll axis)
* written informed consent

Exclusion Criteria:

* coronary heart disease and angina pectoris symptoms
* patient with acute myocardial infarction or CABG while the last 4 weeks
* patient with tachycardia and a rest frequency \>80 bpm
* patient with severe pulmonary disease
* patient with anaemia
* patient with acute infections
* patient with severe kidney or liver disease

Primary outcomes:
measure: Corrected QT Interval in Patients With Pacemaker Dependency
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie
Study officials:
affiliation: Magdeburg University
name: Samir Said, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05006950: SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
Official title: SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cholecystitis
Lead sponsor: Stryker Endoscopy
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also providing a white light 360 degree images.

The primary objective is to determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG: and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older
* Subject is scheduled to undergo laparoscopic cholecystectomy, elective or emergent
* Subject provides informed consent and signs an approved informed consent document for the study
* Subject is willing to comply with the protocol and study visit schedule

Exclusion Criteria:

* Subject is pregnant or lactating
* Subject has a known allergy or history of adverse reaction to ICG, iodine or iodine dyes
* Subject has known history of cholangitis, pancreatitis, prior bile duct injury, coagulopathy or known pre-existing liver disease
* Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigation, interferes with the interpretation of study results, or integrity of the study

Primary outcomes:
measure: Outcome 1
timeFrame: Intra-op visit
Secondary outcomes:
measure: Outcome 2
timeFrame: Intra-op visit
Other outcomes:
measure: Outcome 3
timeFrame: Post op follow- up (7-14 days)
Locations:
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT05390450: Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block After Total Knee Arthroplasty
Official title: Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block for Postoperative Analgesia After Total Knee Arthroplasty: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Popliteal Plexus Block
Fascia Iliaca Block
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 60
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: This study aims to investigate the effect of the Popliteal Plexus Block versus Fascia Iliaca Block on postoperative pain after total knee arthroplasty.

Detailed description: The Popliteal Plexus entwines the popliteal artery and vein contiguous to the adductor hiatus in the popliteal fossa and innervates the posterior capsule as well as intraarticular genicular structures. It was recently confirmed in a cadaver study that injection of 10 mL of dye into the distal end of the adductor canal spreads via the adductor hiatus to the popliteal fossa and stains the Popliteal Plexus.

Recently, fascia iliaca block was proposed as a popular analgesic technique which involves local infiltration anesthesia under the fascia of the iliacus muscle. The method depends on the local anesthetics spread beneath the fascia to block the peripheral nerve. It has been proposed to avoid the complications by anesthetizing the femoral nerve remotely from major neurovascular structures and achieve adequate analgesia.

Eligibility criteria: Inclusion Criteria:

* Age 40 - 75 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) score I-II.
* Scheduled for unilateral, primary TKA under spinal anesthesia.

Exclusion Criteria:

* Coagulopathy.
* Diabetes.
* Obesity.
* Heart failure.
* kidney failure.
* Liver failure.
* Reduced sensation on the lower limb.
* Daily intake of opioids.
* Contraindication to any drug used in the study.

Primary outcomes:
measure: Total intravenous (IV) morphine consumption
timeFrame: 24 hours postoperatively.
Secondary outcomes:
measure: First analgesic request
timeFrame: 24 hours postoperatively
measure: Pain level score
timeFrame: 24 hours postoperatively
measure: Rehabilitation
timeFrame: 24 hours postoperatively
measure: Patient's satisfaction level
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Elgharbia
Study officials:
References:
Clinical trial NCT06868550: Oral Health Promotion Vs. Standard Care in Egyptian Pregnant Women
Official title: Impact of a Comprehensive Oral Health Promotion Program on Maternal Oral Health, Knowledge, Attitudes, and Practices Versus Standard Care in a Group of Egyptian Pregnant Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maternal and Child Health Outcomes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 58
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research question: In pregnant women, does participation in a comprehensive oral health promotion program, compared to standard care, improve maternal oral health, knowledge, attitudes, and practices? This study aims to evaluate the impact of a comprehensive oral health promotion program, compared to standard care, on improving maternal oral health, knowledge, attitudes, and practices among pregnant women. Null hypothesis: There is no significant difference in maternal oral health, knowledge, attitudes, and practices between the group of Egyptian pregnant women who receive the comprehensive oral health promotion program and those who receive standard care. The study population will be pregnant women aged 20 to 45 years. The participants will be categorized into two groups: Intervention will be offered Comprehensive Program and will Include educational workshops, Videos, pamphlets, and support sessions and group chat; and Comparator group will receive Standard care (Limited to oral health sessions only). The study will evaluate three outcomes. Primary outcome The participants will undergo a caries assessment test using The DMFT Index. Secondary outcome The Oral Hygiene Assessment will include the participants using the Simplified Oral Hygiene Index (OHI-S).

Tertiary outcome

1. The knowledge, attitude, and practice (KAP) assessment for pregnant women regarding the Comprehensive Oral Health Promotion Program will be carried out through a prestructured questionnaire. The response data will be collected as frequency and percentage.
2. The nutritional assessment for all participants will be performed using a prestructured questionnaire. The response data will be recorded as frequency and percentage.


Eligibility criteria: Inclusion Criteria:

* Mothers willing to participate.
* Pregnant women from 20 to 45 years
* Participants can understand and communicate

Exclusion Criteria:

* Pre-existing systemic conditions such as diabetes or cardiovascular diseases.
* Participants with a high risk of non-compliance with study requirements

Primary outcomes:
measure: Caries assessment
timeFrame: Baseline, 38 weeks
Secondary outcomes:
measure: Oral Hygiene Assessment
timeFrame: Baseline, Week 12, and week 38
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06330350: Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling
Official title: Investigating Perspectives of Patients With Genodermatosis and Healthcare Professionals on Reproductive Counselling
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Ichthyosis
Palmoplantar Keratoses
Epidermolysis Bullosa
Ectodermal Dysplasia
Basal Cell Nevus Syndrome
Birt-Hogg-Dube Syndrome
Tuberous Sclerosis
Cutis Laxa
Albinism
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients with genodermatosis (i.e, keratinisation disorders, skin fragility diseases, ectodermal dysplasias, dermato-oncological syndromes, other genodermatoses) and a desire to have children, with if applicable his or her partner with a desire to have children, and health care professionals involved with the care of genodermatology patients (e.g. clinical geneticists, dermatologists).

Brief summary: The goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. Additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. To achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals.


Eligibility criteria: Inclusion Criteria:

* Adult patients with genodermatosis (i.e, keratinisation disorders, skin fragility diseases, ectodermal dysplasias, dermato-oncological syndromes, other genodermatoses) and a desire to have children, with if applicable his or her partner with a desire to have children
* Patients with clinically and molecularly confirmed variant of a genodermatosis
* Health care professionals involved with the care of genodermatology patients (e.g. clinical geneticists, dermatologists)

Exclusion Criteria:

* Not being able to communicate verbally in Dutch or English

Primary outcomes:
measure: Assessment of perspectives of affected patients + partners and of healthcare professionals concerning reproductive decision-making
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Antoni Gostynski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03322150: Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia
Official title: Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Anesthesia
Keywords: Atropine
glycopyrrolate
bradycardia
dexmedetomidine
spinal anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing lower extremity surgery with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents are known to often cause hypotension or respiratory depression. Dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the ICU and also in patients undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many patients, which may lead to more serious outcomes when progressing to sinus pause or shock. Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in patients undergoing lower extremity orthopedic surgery with spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

1. Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
2. ASA class 1-3

Exclusion Criteria:

1. Patients with coagulation abnormalities
2. End organ diseases of liver, lung or kidney
3. Severe aortic stenosis
4. High degree AV block
5. Heart failure
6. Patients on MAO inhibitors
7. History of seizures or epilepsy
8. Glaucoma

Primary outcomes:
measure: Pulse rate
timeFrame: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
measure: blood pressure
timeFrame: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02145650: Spasticity Registry Evaluating Epidemiology, Treatment Patterns and Clinical Needs
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Muscle Spasticity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of CP, MS, Stroke, SCI, or TBI in clinical practice evaluated for spasticity.

Brief summary: This study will examine the epidemiology (incidence and control of a disease), burden, clinical need, and treatment patterns of spasticity in patients with a diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI).


Eligibility criteria: Inclusion Criteria:

-Diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI) for a minimum of 3 months

Exclusion Criteria:

-Participation in a spasticity clinical trial in the past 5 years.

Primary outcomes:
measure: Investigator Assessment of Spasticity Severity using a 5-Point Scale
timeFrame: Day 1
measure: Percentage of Participants with Spasticity not Receiving Treatment
timeFrame: Day 1
measure: Spasticity Symptom Assessment Score using a 21-item Questionnaire
timeFrame: Day 1
measure: Spasticity Impact Assessment Score using a 32-item Questionnaire
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants with Spasticity Receiving Treatment
timeFrame: Day 1
measure: Referral Patterns for Spasticity Management
timeFrame: Day 1
measure: Spasticity Screening Tool Score using a 13-item Questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Toms River
country: United States
state: New Jersey
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: