louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02812823: Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children
Official title: Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Children
Fecal Incontinence
Keywords: manometry
children
constipation
functional disorders
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum.

The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.

Detailed description: Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.

Eligibility criteria: Inclusion Criteria:

* Functional Constipation
* Fecal Incontinence
* Parental Agreement

Exclusion Criteria:

* After surgery on lower gastrointestinal tract
* Diagnosis of inflammatory bowel disorders
* Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures
* Lack of parental agreement

Primary outcomes:
measure: Difference in Resting pressure of the anorectal area
timeFrame: 20 seconds
Secondary outcomes:
measure: Maximum squeeze pressure
timeFrame: 1 min
measure: Bear down manoeuver
timeFrame: 1 min
measure: Thresholds of sensation
timeFrame: 1 min
measure: Recto anal inhibitory reflex
timeFrame: 5 min
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatric Gastroenterology and Nutrition
Study officials:
affiliation: Medical University of Warsaw
name: Marcin Banasiuk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banasiuk M, Dobrowolska ME, Skowronska B, Konys J, Banaszkiewicz A. Comparison of Anorectal Function as Measured with High-Resolution and High-Definition Anorectal Manometry. Dig Dis. 2022;40(4):448-457. doi: 10.1159/000518357. Epub 2021 Aug 10.
Clinical trial NCT00669123: Chondroitin Sulphate Efficay/Safety in Patients With Knee Osteoarthritis and Psoriasis
Official title: Fase IV Clinical Trial to Evaluate Chondroitin Sulphate Efficacy and Safety in Patients With Knee Osteoarthritis and Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Psoriasis
Joint Diseases
Muskuloskeletal Diseases
Skin Diseases
Keywords: Chondroitin sulphate
Knee osteoarthritis
Psoriasis
Lead sponsor: Bioiberica
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 126
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpouse of this study is to determine the efficacy and safety of chondroitin sulphate conventional treatment in patients with both knee osteoarthritis and plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Primary knee OA according to ACR criteria;
* OA of radiological stages 1 to 3 according to Kellgren-Lawrence;
* VAS of pain ≥30;
* PASI ≥ 5.

Exclusion Criteria:

* Known allergy to chondroitin sulphate;
* Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis, Wilson's disease;
* Patients with skin conditions that could interfere in the clinical trial evaluation

Primary outcomes:
measure: Huskisson Visual Analogue Scale
timeFrame: Monthly
measure: Psoriasis Area and Severity Index
timeFrame: Monthly
Secondary outcomes:
measure: Lequesne Index
timeFrame: Monthly
measure: Use of rescue medication
timeFrame: Monthly
measure: SF-36 Health Questionaire
timeFrame: 3 months
measure: Overall Lession Severity Scale
timeFrame: Monthly
measure: Physician's Global Assessment of improvement
timeFrame: Monthly
measure: Histological assessment of skin biopsies
timeFrame: 3 months
measure: Dermatology Life Quality Index
timeFrame: Monthly
measure: Tolerability
timeFrame: Monthly
measure: Adverse events
timeFrame: Monthly
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Instituto Poal de Reumatología
Study officials:
affiliation: Hospital del Mar
name: Pere Benito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Poal de Reumatología
name: Montserrat Pérez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Poal de Reumatología
name: Ingrid Möller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moller I, Perez M, Monfort J, Benito P, Cuevas J, Perna C, Domenech G, Herrero M, Montell E, Verges J. Effectiveness of chondroitin sulphate in patients with concomitant knee osteoarthritis and psoriasis: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2010 Jun;18 Suppl 1:S32-40. doi: 10.1016/j.joca.2010.01.018. Epub 2010 May 10.
Clinical trial NCT04014023: Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Official title: A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2019-07-10
Enrollment: 196
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20 to 80 years
* Patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before
* Body Mass Index (BMI) between 20 and 45 kg/㎡
* Patients with 7% ≤ HbA1c ≤ 10% at screening
* Subject who has conducted a stable diet and exercise for at least 8 weeks

Exclusion Criteria:

* Type 1 diabetes mellitus or secondary diabetes
* Severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis)
* Clinical significantly renal disorders
* Creatinine clearance \< 60ml/min (0.84ml/s/㎡) or Glomerular filtration rate(eGFR) \< 60mL/min/1.73
* Severe gastrointestinal disorder
* Uncontrolled hypertension (SBP \>180 mmHg or DBP \> 110 mmHg)
* History of Acute coronary syndrome, unstable angina, myocardial infarction requiring hospitalization, stroke, transient ischemic attack, severe heart failure (NYHA class III/IV), or heart arrhythmia

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: at 12 weeks
Secondary outcomes:
measure: Change from baseline in FPG
timeFrame: at week 4, 8, 12
measure: The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline
timeFrame: at week 4, 8, 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Daewoong pharmatceutical
Study officials:
References:
Clinical trial NCT06558123: Deep Parasternal Intercostal Plane (DPIP) Block
Official title: Comparison of the Effects of Single-Level and Two-Level Deep Parasternal Intercostal Plane (DPIP) Block on Postoperative Sternotomy Pain in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who will undergo sternotomy

Brief summary: In this study, we aimed to compare the effects of this block, which is routinely applied in our hospital but has not been studied in our hospital or in the literature before, on the pain in the first 24 hours after the operation, between the single-level and the two-level block.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years and older
* American Society of Anesthesiologists physical status of II-III
* Undergoing elective coronary artery bypass grafting (CABG), valve repair/replacement, or combined CABG/valve procedure via median sternotomy

Exclusion Criteria:

* Patients who are unable to communicate
* Patients who have had emergency surgery, reoperation, thoracotomy or mastectomy
* Patients with a history of chronic pain
* Patients who are using chronic opioids or sedatives
* Patients who have had a re-sternotomy within 24 hours of surgery
* Patients with liver or kidney failure
* Patients who are using narcotics

Primary outcomes:
measure: numeric rating scale
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye Üniversity
state: Merkez Mahallesi
Study officials:
References:
citation: Zhang Y, Min J, Chen S. Sensory Assessment and Block Duration of Deep Parasternal Intercostal Plane Block in Patients Undergoing Cardiac Surgery: A Prospective Observational Study. Pain Ther. 2022 Sep;11(3):951-958. doi: 10.1007/s40122-022-00403-y. Epub 2022 Jun 25.
citation: Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.
citation: Gelinas C. Management of pain in cardiac surgery ICU patients: have we improved over time? Intensive Crit Care Nurs. 2007 Oct;23(5):298-303. doi: 10.1016/j.iccn.2007.03.002. Epub 2007 Apr 19.
Clinical trial NCT05999123: Menstrual Cycle Study
Official title: Study for the Development of Biometrics-informed Menstrual Cycle Algorithms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstruation
Ovulation
Lead sponsor: Fitbit LLC
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, menstruating individuals between 18 to 42 years of age who meet eligibility criteria from one or more clinical research sites in the United States.

Brief summary: A data collection study to develop algorithms to estimate menstrual cycle phases.


Eligibility criteria: Inclusion:

* Adults who are between 18 - 42 years old at enrollment and menstruate
* Capable of giving informed consent in Spanish or English
* Menstrual cycle lengths between 21- 45 days
* Have tracked menstruation for at least 3 menstrual cycles out of the prior 6 months
* Willing to wear a wrist-worn wearable device continuously for 6 months
* Willing to use an ovulation predictor kit for 6 months
* Willing to report vaccine history
* Owns a smartphone compatible with the study and has access to wi-fi

Exclusion:

* A citizen of the European Union or United Kingdom
* Trying to conceive during the six-month study period
* Have used specific forms of birth control in the 3 months prior to the study or planning on using specific birth control methods during the study duration
* Participant has undergone hormonal treatment in the past 3 months or planning to do so during the study
* Known history of health-related issues that affect their menstrual cycle, history of pelvic radiation, vasomotor symptoms, endometriosis, fibroids, polyps, ovarian cysts or known history of health-related issues that affect the physiology
* Currently (or within the past 3 months) engaged in health impacting behaviors
* Have been breastfeeding or pregnant in the past 6 months prior to the study
* On medications or taking substances that could affect their menstrual cycle or physiology
* Travel frequently such as crossing more than two time zones at least once every 2 weeks
* Have a known sleeping disorder or consistently work night shifts

Primary outcomes:
measure: Ovulation Day Estimation
timeFrame: 6 months
Secondary outcomes:
measure: Menstruation Day Estimation
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Artemis Headlands LLC (Artemis Institute for Clinical Research)
state: California
Study officials:
affiliation: Artemis Institute for Clinical Research
name: Daniel Johnson, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00968123: Consecutive Series Outcomes Review of Patients Undergoing a New Single Portal Technique for Endoscopic Carpal Tunnel Release
Official title: Consecutive Series Outcomes Review of Patients Undergoing a New Single Portal Technique for Endoscopic Carpal Tunnel Release
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carpal Tunnel
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2009-08-28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a consecutive series, retrospective review of the first 50 patients who have undergone carpal tunnel release surgery using a new single portal endocopic technique.

Brief summary: The Purpose of this study is to report a new single portal endoscopic release technique and the sequence of the first 50 patients who underwent this release.

This will be a chart review of the demographics, outcomes, and complications of a sequential series of patients undergoing a Seg-Way Endoscopic carpal tunnel release (ECTR).


Eligibility criteria: Inclusion Criteria:

* This will be a chart review of the first 50 patients who have had surgery using the single portal technique

Primary outcomes:
measure: Functional outcomes following carpal tunnel release
Secondary outcomes:
measure: Complications and return to work data will also be reviewed
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03174223: Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates
Official title: Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates: A Retrospective Analysis of Patient Chart Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Postoperative Wound Infection
Pneumonia
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-06-02
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for laparoscopic abdominal surgery, eye surgery or neuro radiologic intervention surgery under general anesthesia

Brief summary: Deep neuromuscular block (NMB) has shown to produce superior surgical conditions during various abdominal and non abdominal surgeries. It is however unknown if the application of deep NMB leads to favourable outcome, such as lower rate of postoperative complications in general and surgical infections in specific and ultimately lower readmission rates. In the leiden university medical center, deep NMB is routinely applied for a variety of procedures, most notably laparoscopic abdominal and retroperitoneal surgery, eye surgery and neuro radiologic intervention surgery, since 2014. This retrospective study intends to investigate whether the application of deep NMB for these procedures affects patient outcome and readmission rates.


Eligibility criteria: Inclusion Criteria:

* deep neuromuscular block
* moderate neuromuscular block
* general anesthesia
* complete anesthesia chart

Exclusion Criteria:

* incomplete anesthesia chart
* missing data regarding postoperative complications or readmission

Primary outcomes:
measure: Readmission
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Cost
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
References:
Clinical trial NCT04734223: Neuroimaging Findings in Patients With COVID-19
Official title: Correlation of Neuroimaging Findings With Clinical Presentation and Laboratory Data in Patients With COVID-19: A Single Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroimaging
COVID-19
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects more than 18 years old and who are followed up and treated with the diagnosis of COVID-19 in Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital will be included.

Brief summary: This study aimed to discuss the neuroimaging findings and indications, epidemiological data, laboratory values, and the relationship of these variables with mortality in patients with COVID-19.

Detailed description: COVID-19 can present as neurological symptoms such as anosmia, headache, taste perversion, dizziness, syncope, and altered state of consciousness. It has been reported in previous studies that thromboembolic ischemic and hemorrhagic strokes associated with COVID-19 have been observed in the early period. It has been suggested that conditions characterized by neurological sequelae, such as encephalitis and encephalopathy, ataxic seizures, Guillain-Barré syndrome (GBS), demyelinating diseases, and neuromuscular disorders may occur in the longer term.In the present study, the investigators aimed to reveal the findings of neuroimaging analyses performed in patients followed up with a diagnosis of COVID-19 who had neurological symptoms, discuss the relationship of these findings with laboratory and epidemiological data, and emphasize that CNS involvement in these patients should not be overlooked. In this study, 436 patients with COVID-19 who underwent at least one neuroimaging procedure during April 2020-December 2020 due to neurological symptoms and whose diagnosis was confirmed by reverse transcriptase-polymerase chain reaction test were included. Although computed tomography was predominantly used for imaging, magnetic resonance imaging was also used when necessary. The patients were grouped based on imaging findings, and statistical evaluations were made between the groups.

Eligibility criteria: Inclusion Criteria:

* COVID-19 RT-PCR positivity-
* older than 18 years old

Exclusion Criteria:

* younger than 18 years old

Primary outcomes:
measure: Frequency of acute thromboembolism in COVID-19 patients undergoing neuroimaging
timeFrame: Between April and December 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Di̇yarbakir
country: Turkey
facility: Sağlik Bilimleri Üniversitesi Training and Research Hospital
Study officials:
affiliation: SAGLIK BİLİMLERİ ÜNİVERSİTESİ TRAINING AND RESEARCH HOSPITAL H
name: ŞEYHMUS KAVAK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01720823: Obstructive Sleep Apnea Syndrome (OSA) and Getemed
Official title: Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea syndrome
polysomnography
Home monitoring
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 62
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital.

Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, aged 2 to 6 years old, requiring a polysomnography or admitted for intense snoring or suspected sleep apnea
* Parents must have signed the inform consent form and be covered by the National Health Insurance Program.

Exclusion Criteria:

* Parents opposed to the study.

Primary outcomes:
measure: Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children.
timeFrame: 1 night
Secondary outcomes:
measure: To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography.
timeFrame: 1 night
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon- Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon- Hôpital Femme Mère Enfant
name: Patricia FRANCO, MD
role: PRINCIPAL_INVESTIGATOR
References: