louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02661867: Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section
Official title: Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section: Seven to Twelve-Year Long Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Disorders
Keywords: Childbirth
Pelvic organ prolapse
Urinary incontinence
Fecal incontinence
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 865
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primiparae delivered vaginally (VD group) or by cesarean section (CS group) during the years 2002-2007 in university-based large perinatology center

Brief summary: Objective of this longitudinal observational cohort study was to analyze incidence of pelvic floor dysfunction (PFD) symptoms, including pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI), seven to twelve years after delivery, in two groups of singleton primiparae after vaginal delivery (VD) and cesarean section (CS).

Detailed description: Pelvic floor disorders (PFD) usually refers to three definable groups of symptoms that include pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI). The prevalence of these conditions increases with age, but in general, PFD affect 20-50 % of women throughout their lives. Thus, PFD are common and have significant societal impact. Another important PFD risk factor is childbearing. Specifically, these disorders are more common among multiparas. Vaginal delivery (VD) has been considered the main contributing factor because of pelvic floor muscle, fascia, and nerves damage.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* cephalic presentation
* delivery in term (gestational week 38-42)
* no other childbirth during study period

Exclusion Criteria:

- operative vaginal delivery (vacuum extraction or forceps delivery)

Primary outcomes:
measure: Pelvic organ prolapse symptoms score
timeFrame: seven years after delivery
Secondary outcomes:
measure: Urinary incontinence symptoms score
timeFrame: seven years after delivery
measure: Fecal incontinence symptoms score
timeFrame: seven years after delivery
Other outcomes:
Locations:
Study officials:
References:
citation: Memon H, Handa VL. Pelvic floor disorders following vaginal or cesarean delivery. Curr Opin Obstet Gynecol. 2012 Oct;24(5):349-54. doi: 10.1097/GCO.0b013e328357628b.
citation: Huser M, Janku P, Hudecek R, Zbozinkova Z, Bursa M, Unzeitig V, Ventruba P. Pelvic floor dysfunction after vaginal and cesarean delivery among singleton primiparas. Int J Gynaecol Obstet. 2017 May;137(2):170-173. doi: 10.1002/ijgo.12116. Epub 2017 Mar 1.
Clinical trial NCT00178867: A National Registry of Patients With Hepatocellular Carcinoma
Official title: A National Registry of Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 150
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: All patients seen in Hepatobiliary Surgery Clinic at Vanderbilt University Medical Center who are diagnosed with hepatocellular carcinoma.

Brief summary: A registry of patients with the diagnosis of hepatocellular carcinoma.

Detailed description: The purpose of this research is to study the factors which might cause hepatocellular carcinoma (a form of cancer arising within the liver) and compare these factors in patients from different ethnic groups and from different parts of the United States. The researchers will also conduct a survey of the stage of the cancer (how far advanced it is) and what treatments are used for this difficult-to-treat tumor.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of hepatocellular carcinoma

Exclusion Criteria:

* Patients can not be under 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Ravi S Chari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01042067: Safer Warfarin Treatment
Official title: Safer Warfarin Treatment - the Influence of CYP2C9 Genotyping, Genotyping of Vitamine K Dependent Proteins and Dietary Vitamine K Status on Dosing, Clinical Effect and Adverse Events With Emphasis on the Initial Phase of Treatment
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Atrial Fibrillation
Venous Thrombosis
Pulmonary Embolism
Heart Valve Prosthesis
Keywords: warfarin
genotyping
vitamin K
dosing
adverse events
initial phase of treatment
algorithm
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian Medicines Agency
name: Norway: South-Eastern Norway Regional Health Authority
First posted: 2010-01-05
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: NON_PROBABILITY_SAMPLE
Study population: Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment. About 200 patients will be included.

Brief summary: The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.


Eligibility criteria: Inclusion Criteria:

* Caucasian
* \>18 years of age
* included in the study at the onset of warfarin treatment
* target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves)
* standard indications for warfarin treatment

Exclusion Criteria:

* Non-caucasian
* Clinical significant liver affection
* Heart failure, NYHA class III-IV
* Non-compliant - not able to accomplish protocol demands
* Not able to give informed consent
* Long-term antibiotic therapy
* Malabsorption conditions and inflammatory bowel disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT00563667: Effect of Pterygium Excision on Intraocular Lens Power Calculation for Subsequent Cataract Operation
Official title: Effect of Pterygium Excision on IOL Power Calculation: Concurrent Cataract and Pterygium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pterygium
Cataract
Astigmatism
Keywords: Pterygium
Cataract
Astigmatism
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pterygium is known to induce with-the-rule astigmatism. Excision of pterygium will steepen the cornea and reduce corneal astigmatism. We postulate that the alteration of keratometry reading will indirectly affect the IOL power calculation in cases with concurrent pterygium and cataract. Concurrent pterygium and cataract is common in Hong Kong and other tropical regions. The effect of pterygium excision on intraocular lens power calculation is investigated.


Eligibility criteria: Inclusion Criteria:

* All cases with concomitant cataract and primary pterygium, which are indicated for surgery.

Exclusion Criteria:

* Pterygium smaller than 1mm, which is not visually significant.
* Double headed pterygium
* Pterygium obscuring visual axis that preclude keratometry or autorefraction measurements.
* Previous corneal refractive surgery that alter the keratometric power of the cornea.
* Patients with medical problems that preclude staged ocular surgery, e.g. dementia, heart disease, on warfarin.

Primary outcomes:
measure: IOL power
timeFrame: 1 and 3 months post pterygium excision
measure: Astigmatism
timeFrame: 1 and 3 months post pterygium excision
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Alice Ho Miu Ling Nethersole Hospital
city: Hong Kong
country: China
facility: Hong Kong Eye Hospital
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Department of DOVS, Prince of Wales Hospital/ The Chinese University of Hong Kong
name: Lulu Cheng, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06502067: Efficacy of Serratus Posterior Intercostal Plane Block for Analgesia and Inflammatory Marker in Breast Surgery
Official title: Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Perioperative Analgesia and Inflamatory Markers in Breast Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breastcancer
Perioperative Pain
Inflammation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficiacy of serratus posterior superior block in controlling perioperative breast cancer surgery pain and its effect on inflamatory markers.

Detailed description: Back ground The presence of pain during the initial course of treatment in women with early-stage breast cancer was associated with significantly higher levels of c-reactive protein(CRP) ,interleukin-7(IL-7)and interleukin-13(IL-13) There is evidence of effectiveness of regional block in controlling inflamatory markers Serratus posterior superior intercostal plane block (SPSIPB) is a novel Regional technique that provides analgesia in the hemithorax, shoulder, and back of the neck which proved its efficacy in controlling pain after Video assisted thoracoscopic surgery there are little epidemiological data on (SPSIPB)usage in masectomy and lumpectomy procedures and its effect on inflamatory markers

Methodology:

* Type of the Study: Randomized prospective comparative controlled double-blinded study

  * Study Setting: Ain Shams University Hospitals
  * Study Period: One year after approval of the protocol.
  * Place :Ain shams university hospitals
  * Study Population: Adult patients who will undergo breast cancer surgey.

Eligibility criteria: Inclusion Criteria:

* Adults undergoing unilateral breast surgery under general anesthesia
* Age 21 to 60 years with body mass index (BMI)=18 to 25 kg/m2
* American Society of Anesthesiologists (ASA) grade I-III.

Exclusion Criteria:

* Patients with Long-time use of analgesic drugs
* Past history of chest surgery,
* Allergy to local anesthetics,
* Systemic infection,
* Cognitive and language disorders precluding participation,
* Patients with coagulopathy,anticoagulant users
* hemodynamic unstable patients
* Patients with neurology, spinal, psychiatry diseases
* infection at block site
* patients refused to participate in the study .

Primary outcomes:
measure: is to calculate total perioperative analgesia consumption throughout (24hours).
timeFrame: 24 hour postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06171867: PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring
Official title: Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Respiratory Distress
Keywords: Electrical impedance tomography, neonate
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Middlesex University
First posted: 2023-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The device feasibility will be assessed in clinical environment with feedback from both the patient parents and nurses in NICU/PICU.
Primary purpose: OTHER

Brief summary: The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.

Detailed description: Electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. This feasibility study will assess the usability of a new PNEUMACRIT electrode belt in clinical environment.

Eligibility criteria: Inclusion Criteria:

* Inpatient at Oulu University Hospital PICU or NICU
* Gestational age at birth over 32 weeks
* Weight 2000-5000g
* Postnatal age \> 12 hours
* Written informed consent from the parents of legal representative
* Non-invasive monitoring of oxygen saturation and ECG

Exclusion Criteria:

* Postmenstrual age \< 32 weeks
* Weight at time of the study \< 2000g or \> 5000g
* Chest skin lesion preventing safe use of the electrode belt
* Recent chest surgery within the past 7 days (e.g. thoracotomy)

Primary outcomes:
measure: Proportion (%) of recording time with high quality EIT-signal
timeFrame: 6-24 hours
Secondary outcomes:
measure: Staff and parent questionnaires
timeFrame: 48 hours
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
References:
Clinical trial NCT05697367: Swiss Childhood Health and Nutrition Survey 2023
Official title: Swiss Childhood Health and Nutrition Survey 2023
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 1245
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: School aged children living in Switzerland

Brief summary: This study will repeat previous studies done in 2002, 2007 2012 and 2017/18, in order to monitor the trend in the prevalence of overweight and obesity in 6-12 year old children in Switzerland over the entire period. Furthermore, additional risk factors will be assessed for the later development of NCD using a questionnaire comparable to the one used in 2017/18.

Detailed description: A total of ca. 2500 children will be recruited throughout Switzerland and their height, weight, waist circumference as well as percentage body fat will be measured. In addition, children will be asked to complete a questionnaire on some aspects of their diet, physical activity, health and socioeconomic background. Data will be compared to previous surveys conducted since 2002 to monitor trends in overweight and obesity prevalence in Switzerland. The results from the questionnaire will be used to investigate risk factors for obesity and the later development of NCDs.

Eligibility criteria: Inclusion Criteria:

* age between 6 and 12 years

Exclusion Criteria:

* none

Primary outcomes:
measure: Prevalence of overweight and obesity
timeFrame: baseline
Secondary outcomes:
measure: waist circumference
timeFrame: baseline
measure: percent body fat
timeFrame: baseline
measure: physical activity
timeFrame: baseline
measure: Nutrition
timeFrame: baseline
measure: General health
timeFrame: baseline
measure: Parental education
timeFrame: baseline
measure: Country of birth
timeFrame: baseline
Other outcomes:
measure: Age
timeFrame: baseline
measure: Sex
timeFrame: baseline
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
Study officials:
affiliation: ETH Zurich
name: Isabelle Herter-Aeberli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03950167: Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum
Official title: Gallbladder Functions & Serum Cholecystokinin Levels in Pregnant Women Diagnosed With Hyperemesis Gravidarum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperemesis Gravidarum
Pregnancy Related
Keywords: gallbladder functions
cholecystokinin
hyperemesis gravidarum
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 325
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum before 14 weeks of pregnancy

Brief summary: This study evaluates the gallbladder functions and serum cholecystokinin levels in pregnant women diagnosed with hyperemesis gravidarum. Half of the participants are healthy pregnant women and half of the participants are pregnant women diagnosed with hyperemesis gravidarum. Two groups will be compared by means of gallbladder functions and serum cholecystokinin levels.

Detailed description: Previously gallbladder functions have been observed in human with gallbladder disease. However it has never been evaluated whether there is any difference in gallbladder functions between healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum. Moreover correlation between hyperemesis gravidarum symptom scores and gallbladder functions has never been assessed. There is also few data comparing serum cholecystokinin levels between healthy pregnant women and those diagnosed with hyperemesis gravidarum. The investigators will measure serum cholecystokinin levels after a fatty meal (100 g chocolate) and compare two groups. In this study the investigators would like to evaluate gallbladder functions and serum cholecystokinin levels in women with hyperemesis gravidarum and compare these with healthy subjects.

Eligibility criteria: Inclusion Criteria:

* gestation week between 6 and 14 weeks,
* singleton pregnancy with a live embryo,
* healthy women without any medical disorders,

Exclusion Criteria

* any systemic disease,
* gallbladder disease
* any psychological disorder that can cause vomiting,
* multiple gestation

Primary outcomes:
measure: Blood Cholecystokinin (CCK) Levels
timeFrame: Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level
measure: Gallbladder (GB) Wall Thickness
timeFrame: fasting and postprandial 45th minute
measure: Gallbladder (GB) Volume
timeFrame: fasting and postprandial 45th minute
measure: Gallbladder (GB) Ejection Fraction
timeFrame: The fasting and postprandial 45th minute
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University Hospital
Study officials:
affiliation: Ufuk University
name: Muge Keskin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01708967: Trial of New Pretreatment Method in Transnasal Endoscopy
Official title: One-time Spray of Epinephrine (1cc) Plus 4% Lidocaine (4cc) is Sufficient Pretreatment Method for the Preparation of Transnasal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pretreatment Method of Transnasal Endoscopy
Keywords: transnasal endoscopy
pretreatment method
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2012-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy

* "Catheter-free method"
* "Catheter-insertion method"

Detailed description: 1. Check of the medical history (both method)

   1. underlying systemic disease
   2. drug allergy
   3. anticoagulant or antiplatelet use
2. Premedication (both method)

   1. taking premedication contain dimethylpolysiloxane, pronase, sodium bicarbonate for improved endoscopic visualization
   2. spraying naphazolin acetate into nasal cavity for decrease secretion
3. Different anesthetic method for transnasal endoscopy

   1. "Catheter-free method" : spraying epinephrine into nasal cavity
   2. "Catheter-insertion method" : spraying both epinephrine and lidocaine into nasal cavity

Eligibility criteria: Inclusion Criteria:

* Routine check-up patients

Exclusion Criteria:

* nasal operation, an allergy, a possibility of hemorrhage

Primary outcomes:
measure: Success Rate of Transnasal Endoscopy
timeFrame: During transnasal endoscopy, up to 1 hours
Secondary outcomes:
measure: Vital Signs
timeFrame: before, during, and after transnasal endoscopy
Other outcomes:
measure: Satisfaction
timeFrame: after transnasal endoscopy
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Study officials:
affiliation: Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
name: Ki Tae Suk, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: