louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02928003: Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors
Official title: Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Lung surgery
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other factors (genetic, psychological) could have a major and independent role in the development of the post operative pain.The main objective of this study is to identify genetic and psychological profile (cognitive and emotional) of patients who develop chronic pain after lung surgery.


Eligibility criteria: Inclusion Criteria:

* Undergoing lung resection surgery.
* 18 years and older (without superior limit);
* Affiliated to french "securité sociale"

Exclusion Criteria:

* Emergency procedure
* litigation or search for compensation;
* Previous intervention in the same region;
* Peripheral neurological pathology (polyneuropathy) or central (brain damage, multiple sclerosis ...) that may interfere with the evaluation of the post-operative pain
* Participation in another biomedical research protocol if there is an incompatibility with the present protocol.
* mental disability
* vulnerable person within the meaning of French law,
* poor understanding of French.

Primary outcomes:
measure: Number of patients with chronic pain 4 months after surgery
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Mireille Michel-Cherqui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02112903: Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women
Official title: Interventional, Randomised, Double-blind 4-way Crossover Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Women
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR) tablet.


Eligibility criteria: Inclusion Criteria:

* Healthy women ≥18 and ≤45 years of age with a body mass index (BMI) of \>18.5 and \<30.0 kg/m2.
* Women will be of child-bearing potential with a confirmed non-pregnant and non-lactating status.

Other protocol-defined Inclusion and Exclusion Criteria may apply.

Primary outcomes:
measure: Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale
timeFrame: Up to 24 hours post-dose in each treatment period
measure: Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale
timeFrame: Up to 24 hours post-dose in each treatment period
measure: Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale
timeFrame: Up to 24 hours post-dose in each treatment period
measure: Frequency, severity and duration of reported gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort and abdominal pain)
timeFrame: Up to 72 hours post-dose in each treatment period
measure: Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
timeFrame: Up to 72 hours postdose
measure: Maximum observed concentration (Cmax) of vortioxetine
timeFrame: Up to 72 hours postdose
measure: Nominal time corresponding to the occurrence of Cmax (tmax)
timeFrame: Up to 72 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GB801
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT05208203: XuanwuH Acute Ischemic Stroke Registry
Official title: Acute Ischemic Stroke "Green Channel" Registry--Xuanwu Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Cerebrovascular disease
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 500
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: all acute stroke patients with the clinical diagnosis of acute ischemic stroke, Age \>18 years

Brief summary: Acute ischemic stroke registry--Xuanwu Hospital(XSR) is an academic, independent, prospective, single center, observational registry study. Consecutive acute ischemic stroke patients assessed in stroke "green channel" of Xuanwu Hospital(China) will be enrolled in our study. Patients receive regular treatment and data will be collected as part of clinical routine. Baseline clinical and procedural information as well clinical follow-up information during in-hospital stay, and up to 90 days of stroke onset are collected. Data collected include demographics, National Institute of Health Stroke Scale (NIHSS) on admission, pre-treatment ASPECTS, information on timing and success of thrombolysis or thrombectomy, procedural complications, intracranial hemorrhage, and functional outcome.The study aim to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients in "green channel",and verify the effect of the improvement of "green channel" process in the diagnosis and treatment of patients with acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute ischemic stroke or transient ischemic attack(TIA)
* Age \>18 years
* Ethic approval in process
* Receiving assessment in stroke "green channel" of Xuanwu Hospital

Exclusion Criteria:

* Non-acute ischemic stroke

Primary outcomes:
measure: modified ranking scale on day (mRs) day 90
timeFrame: 90 days
Secondary outcomes:
measure: Stroke Event
timeFrame: 1year
measure: adverse event
timeFrame: 1year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: qingfeng Ma, MD
role: STUDY_CHAIR
References:
citation: GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
citation: Harris D, Hall C, Lobay K, McRae A, Monroe T, Perry JJ, Shearing A, Wollam G, Goddard T, Lang E. Canadian Association of Emergency Physicians position statement on acute ischemic stroke. CJEM. 2015 Mar;17(2):217-26. doi: 10.1017/cem.2015.26.
citation: van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.
Clinical trial NCT06928103: Comparison of the Acute Effects of Different Warm-up Protocols in Overhead Athletes With Posterior Shoulder Tightness
Official title: Comparison of the Acute Effects of Different Warm-up Protocols on Shoulder Mobility, Muscle Stiffness, Muscle Power Performance, Shoulder Functional Ability and Shoulder Endurance in Overhead Athletes With Posterior Shoulder Tightness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posterior Shoulder Tightness
Keywords: Posterior Shoulder Tightness
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the immediate effects of different warm-up protocols on Shoulder mobility, Muscle stiffness, Muscle power performance, Shoulder functional ability and Shoulder endurance in overhead athletes with posterior shoulder tightness


Eligibility criteria: Inclusion Criteria:

* Recreational or amateur athletes between the ages of 18 and 40
* Training time exceeding four hours per week
* Shoulder internal rotation is reduced by more than 15 degrees compared to the non-dominant side, or the sum of shoulder external rotation and internal rotation is less than 15 degrees compared to the non-dominant side or Shoulder horizontal adduction is reduced by move than 15 degrees compared to the non-dominant side

Exclusion Criteria:

* Shoulder pain within the past three months
* History of shoulder fracture, dislocation, or soft tissue tear surgery in the past
* Contraindications for massage include: open wounds in the treatment area, skin cancer, infections in the treatment area, and severe edema

Primary outcomes:
measure: Passive range of motion
timeFrame: Pre-intervention and post intervention (immediate effect)
measure: Active range of motion
timeFrame: Pre-intervention and post intervention (immediate effect)
measure: Muscle stiffness
timeFrame: Pre-intervention and post intervention (immediate effect)
measure: Power performance
timeFrame: Pre-intervention and post intervention (immediate effect)
Secondary outcomes:
measure: Functional performance - Y balance test upper quarter
timeFrame: Pre-intervention and post intervention (immediate effect)
measure: Functional performance - closed kinetic chain upper extremity stability test (CKCUEST)
timeFrame: Pre-intervention and post intervention (immediate effect)
measure: Shoulder endurance
timeFrame: Pre-intervention and post intervention (immediate effect)
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: No. 155, Sec. 2, Linong St. Beitou Dist., Taipei City 112304, Taiwan
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
References:
Clinical trial NCT06188403: Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery
Official title: Comparison of Radiographic Accuracy Between Pre-bent Titanium Plates and 3D Customized Titanium Plates After le Fort 1 Osteotomy in Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthognathic Surgery
Keywords: orthognathic
virtual planning
custom plates
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery.


Eligibility criteria: Inclusion Criteria:

* . Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy.

Exclusion Criteria:

1. Patients with acute infection at surgery site.
2. Patient with Systemic disorders contraindicating surgery.
3. Smokers.
4. Alcohol or drug abuse is prohibited.
5. patients who suffered from craniofacial syndrome.
6. patients who had previous orthognathic surgery.
7. patients who had previous maxillary or mandibular trauma

Primary outcomes:
measure: Radiographic accuracy between postoperative plan and postoperative result.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of dentistry
Study officials:
References:
Clinical trial NCT03945903: Pre-Approval Access to Golimumab Subcutaneous for the Treatment of Stage 3 Type-1 Diabetes Mellitus in Children and Young Adults
Official title: SIMPONI SC Managed Access Program
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-05-10
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is a Single Patient Investigational New Drug (IND) to golimumab subcutaneous (SC) for the treatment of recently diagnosed Stage 3 type-1 diabetes mellitus (T1D) in children and young adults. The main purpose of a single patient IND is to provide treatment to participants with serious/life-threatening diseases or conditions prior to marketing authorization.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT03273803: Cardiac Auscultation Using Smartphones
Official title: Cardiac Auscultation Using Smartphones: a Proof-of-concept Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Physiological Phenomena
Keywords: Heart sounds, smartphone, application
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Advanced Institute of Science and Technology
First posted: 2017-09-06
Enrollment: 46
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women were evenly enrolled, and the median age was 65.5 years.

Twenty subjects (43.5%) had systolic murmur, 20 (43.5%) normal heart sound, 5 (10.9%) diastolic murmur, and 1 (2.2%) S4.

Brief summary: The investigators performed a proof-of-concept study enrolling subjects with normal and pathologic heart sounds. Heart sound was recorded by auscultation on the skin of the chest wall using three smartphones: Samsung Galaxy S5 and Galaxy S6, and LG G3 . Recorded heart sounds were processed and classified by a diagnostic algorithm using convolutional neural networks.

Detailed description: Heart sound recording was done by researchers who were familiar with the use of the app and understand the principles of cardiac auscultation.

Reference heart sounds were recorded using an electronic stethoscope (3M™ Littmann® Electronic Stethoscope Model 3200). Study devices included Samsung Galaxy S5 (model SM-G900), Galaxy S6 (SM-G920), and LG G3 (LG-F400).

Eligibility criteria: Inclusion Criteria:

* subjects who gave informed consent
* subjects who are 18 years old or older and had performed ECG and echocardiography during the previous 6 months.

Exclusion Criteria:

* subjects with impairment of cognition

Primary outcomes:
measure: Accuracy of "CPstethoscope" in interpretation of heart sounds
timeFrame: 0
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung-Won Suh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang SH, Joe B, Yoon Y, Cho GY, Shin I, Suh JW. Cardiac Auscultation Using Smartphones: Pilot Study. JMIR Mhealth Uhealth. 2018 Feb 28;6(2):e49. doi: 10.2196/mhealth.8946.
Clinical trial NCT00763503: Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis
Official title: Pharmacokinetic and Pharmacodynamic Study of CD 2027 3µg/g Oily Spray Applied Twice Daily for 3 Weeks Under Conditions of Maximized Use in Adults With Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque-type Psoriasis
Keywords: psoriasis
PK
calcitriol
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-10-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label study to assess systemic plasma levels of calcitriol, calcium homeostasis and safety in adults with plaque-type psoriasis under conditions of maximized use of CD 2027 3µg/g oily spray twice daily (6 g daily), applied to 20% of BSA for 3 weeks.

There are a total of six visits: Pre-treatment period (Day -15, Day -8 and Day -1) and Treatment period (Day 1/ Baseline, Day 15 and Day 22).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of plaque-type psoriasis involving 10% - 20% of body surface area (BSA), with a Global Severity Score of at least 3 (moderate)

Exclusion Criteria:

* Other type of psoriasis (other than plaque)
* Significant abnormal lab findings
* Secondary hyperparathyroidism
* Vit D deficiency
* Hypercalcemia

Primary outcomes:
measure: CD 2027 plasma concentrations
timeFrame: 0, 1, 2, 3, 4, 6, 9, 12 hour time points
Secondary outcomes:
measure: Calcium homeostasis
timeFrame: Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arizona
city: Austin
country: United States
facility: DermResearch
state: Texas
city: Bryan
country: United States
facility: J & S Studies
state: Texas
Study officials:
References:
Clinical trial NCT01780103: Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis
Official title: Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pyelectasis of Newborns
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-01-30
Enrollment: 143
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns at the age of 0-1 months

Brief summary: In this retrospective study the investigators will enroll newborns that were born between 01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of Pyelectasis according to prenatal sonographic screening test.

These babies underwent renal sonography at the age of 2-5 days according to the protocol and were invited to an additional renal sonographic screening test at the age of 1 month.

The investigators will compare the results of the 2 examinations and the investigators will try to reach conclusions whether there is correspondence between the severity of the pyelectasis in the first and second sonographic tests and the outcome of these newborn babies


Eligibility criteria: Inclusion Criteria:

* All newborns that were born at Hillel Yaffe Medical Center with prenatal diagnosis of Hydronephrosis between 01.01.2010-31.12.2012

Exclusion Criteria:

* None

Primary outcomes:
measure: severity of hydronephrosis by sonographic measures
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02560103: An Observational Study to Investigate the Effects of Rapid Transmeridian Travel
Official title: An Observational Study to Investigate the Effects of Rapid Travel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jet Lag Disorder
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Observational study to investigate circadian rhythm patterns


Eligibility criteria: Inclusion Criteria:

* Ability and acceptance to provide written consent
* Men or women between 18-75 years
* Body Mass Index of ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

* History (within the 12 months prior to screening) of psychiatric disorders
* Major surgery, trauma, illness or immobile for 3 or more days within the past month
* Pregnancy or recent pregnancy (within 6 weeks)
* A positive test for drugs of abuse at the screening visit
* Any other sound medical reason as determined by the clinical investigator

Primary outcomes:
measure: Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG)
timeFrame: 4 days
measure: Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel.
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Chevy Chase
country: United States
facility: The Center for Sleep & Wake Disorders
state: Maryland
Study officials:
References: