louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02041078: Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
Official title: Randomized Phase 2 Study of Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Reduction of Peroperative Blood Loss During Liver Resection
Keywords: Liver surgery
Blood loss
CUSA
Hepatic transection
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Jansson, Anders, M.D.
name: Bengt Isaksson
First posted: 2014-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Intrahepatic division of the hepatic vein is associated with less blood loss than extrahepatic dissection and division of the right hepatic vein.


Eligibility criteria: Inclusion Criteria:

* Hepatic lesion amenable to right sided hemihepatectomy.

Exclusion Criteria:

* Hepatic lesions not suitable for a anatomical right sided hemihepatectomy.
* Unfit for surgery
* Unwillingness to participate

Primary outcomes:
measure: Intraoperative bloodloss
timeFrame: Intraoperative time (in minutes) for the division of the liver parenchyma
Secondary outcomes:
measure: Operation time, postoperative complication rate
timeFrame: Total time in minutes spent in theater, in hospital stay in days (on an average less than 30 days), total complication rate during hospital stay (on an average less than 30 days), surgical complications during in hospital stay (on an average<30days).
measure: postoperative complication rate
timeFrame: in hospital stay in days (on an average <30 days), total complication rate during hospital stay (on an average <30 days), surgical complications during in hospital stay (on an average <30 days).
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Surgery Gastrocentrum Karolinska Univeristy Hospital
Study officials:
affiliation: Gastrocentrum Karolinska University Hospital Huddinge, 141 86 Stockholm
name: Lars Lundell, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05831878: RC48-ADC in HER2-low Advanced Breast Cancer
Official title: Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.

Detailed description: Subjects with HER2-low advanced breast cancer were treated with Disitamab vedotin as salvage treatment. ORR, PFS, OS and AE were assessed during the trial. HER2-low status is defined as IHC1+ or IHC2+ with negative FISH test.

Eligibility criteria: Inclusion Criteria:

* Female patients aged 18-70 years (including 18 years and 70 years)
* Expected survival ≥12 weeks
* ECOG 0-1
* Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
* At least one measurable lesion according to the RECIST 1.1
* No history of antibody-drug conjugate use
* Up to one previous chemotherapy for advanced disease
* Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease
* HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test
* Adequate organ function

Exclusion Criteria:

* History of thromboembolic events
* Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
* Active infections requiring systemic treatment
* Pregnant or lactating
* Presence of brain metastases and/or carcinomatous meningitis

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year)
Secondary outcomes:
measure: Adverse events
timeFrame: From the date of starting Disitamab Vedotin to the end of the treatment (up to approximately 1 year)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
affiliation: Renji Hospital,School of Medicine, Shanghai Jiaotong University
name: Wenjin Yin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04313478: The Relationship Between Segmental Trunk Control and Gross Motor Performance in Low Birth Weight Born Infant
Official title: The Relationship Between Segmental Trunk Control and Gross Motor Performance in Low Birth Weight Born Infant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Intervention
Low Birth Weight Infants
Term Infants
Keywords: Early intervention, trunk control, low birth weight, term
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2020-03-18
Enrollment: 85
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Low birth weight and normal weight infants

Brief summary: This study aimed to examine the relation between trunk control and gross motor performance in LBW and NBW infants.

Detailed description: Preterm infants are observed to have reduced trunk extension in the prone position, rigid postural patterns while reaching a toy, fewer movement reactions, trunk rotation, head control, and muscle tone than term infants. To distinguish between the infant with typical motor development and the one with atypical / abnormal motor development and to follow up the level of their trunk controls is important to identify of the motor development delay in the early stage of life.

This cross-sectional study included 42 LBW infants and 43 NBW infants at between 3 and 9 months of age. We investigated the association between the gross motor function and the segmental trunk controls of the LBW infants at the 3-9 months of age compared to NBW infants.

Eligibility criteria: Inclusion Criteria:

* the written consent given by the parents,
* being at 3 to 9 months' corrected age,
* gestational age of less than 36 weeks + 6 days,
* birth weight of 2000 g or less.

Exclusion Criteria:

* Infants with any genetic, metabolic, orthopedic congenital abnormalities or chronic diseases and parents' rejection to participate in the study
* Term infants that presented any type of sensory or motor disorder were excluded.

Primary outcomes:
measure: Alberta Infant Motor Scale (AIMS)
timeFrame: 15 min
measure: Segmental Assessment Trunk Control (SATCo)
timeFrame: 20 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Medipol University Hospital
name: Seval Kutlutürk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01432678: Vitamin D Status in Pediatric Asthma
Official title: Vitamin D Status in Pediatric Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Keywords: vitamin D
asthma
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: allergy clinic in tertiary hospital

Brief summary: The purpose of this study is to evaluate level of vitamin D in pediatric asthma and relationship between vitamin D and level control of asthma.

Detailed description: cross-sectional study

Eligibility criteria: Inclusion Criteria:

* children between the age of 6 years and 18 years with the diagnosis of asthma who are attending the outpatient pediatric department, pediatric allergy clinic

Exclusion Criteria:

* patients who have chronic pulmonary, heart disease, chronic renal failure, liver disease, endrocrine disorder, or receieve antiepileptic drugs, vitamin D supplement

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Allergy and Immunology, Department of Pediatrics, Faculty of medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Siriraj Hospital
name: Orathai Piboonpocanun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krobtrakulchai W, Praikanahok J, Visitsunthorn N, Vichyanond P, Manonukul K, Pratumvinit B, Jirapongsananuruk O. The effect of vitamin d status on pediatric asthma at a university hospital, Thailand. Allergy Asthma Immunol Res. 2013 Sep;5(5):289-94. doi: 10.4168/aair.2013.5.5.289. Epub 2013 Aug 12.
Clinical trial NCT01921478: A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis
Official title: Retrospective, Multi-center, Observational Study of Daily Practice Patterns and Outcomes of the Management of Rheumatoid Arthritis Patients Without Documented Erosions Treated With RoACTEMRA in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-08-13
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective survey of medical records from patients with moderate to severe rheumatoid arthritis treated with RoActemra/Actemra (tocilizumab) who did not have documented erosions at the start of RoACTEMRA treatment .

Brief summary: This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>=18 years of age
* Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 \>=5.1
* Inadequate responder to at least 2 non-biological DMARDs
* Absence of documented erosions at start of RoActemra/Actemra treatment
* Received RoActemra/Actemra treatment for at least 6 months
* Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit

Exclusion Criteria:

* Contraindications for treatment with RoActemra/Actemra

Primary outcomes:
measure: Joint erosion assessment in clinical practice
timeFrame: 6 months
Secondary outcomes:
measure: Disease Activity Score 28
timeFrame: 6 months
measure: C-reactive protein assessment
timeFrame: 6 months
measure: Swollen joint counts
timeFrame: 6 months
measure: Tender joint counts
timeFrame: 6 months
measure: Erythrocyte Sedimentation Rate
timeFrame: 6 months
measure: Evolution of the pattern of joint erosion
timeFrame: 6 months
measure: Patient's global assessment of disease activity (Visual Analogue Scale)
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Gilly
country: Belgium
city: Seraing
country: Belgium
city: Verviers
country: Belgium
city: Westmalle
country: Belgium
city: Wilrijk
country: Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02224378: Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valvular Heart Surgery
Keywords: fluid responsiveness
atrial fibrillation
passive leg raising
central venous pressure
valvular heart surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac surgery in patients with sinus rhythm, and was speculated to be of value in patients with rhythm other than sinus. The aim of this study is to assess the predictability of PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular heart surgery.


Eligibility criteria: Inclusion Criteria:

1. age ≥20
2. atrial fibrillation patients who underwent elective valvular heart surgery

Exclusion Criteria:

1. age \< 20
2. LV ejection fraction \< 40%
3. any pulmonary disease
4. end stage renal disease
5. high intrabdominal pressure patient
6. contraindication of passive leg raising
7. deep vein thrombosis

Primary outcomes:
measure: fluid responsiveness
timeFrame: 1hr after arriving at ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine
Study officials:
References:
Clinical trial NCT00742378: Discriminating Ability of the Cirrus High Definition (HD) Optical Coherence Tomography (OCT) for Glaucoma
Official title: Discriminating Ability of the Cirrus HD OCT for Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: Glaucoma
Retinal nerve fiber layer
Cirrus OCT
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients and normal controls

Brief summary: The Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for glaucoma detection will be studied.

Detailed description: The Cirrus HD OCT is a newly developed imaging device of the spectral domain optical coherence tomography. Even though its resolution and speed are much better than the previous OCT, its reproducibility and diagnostic power for detecting the glaucomatous defect of retinal nerve fiber layer (RNFL) have not known yet. In the present study, we will review the data of RNFL thickness measurement using the Cirrus HD OCT. After assessing the inter-test variability, the discriminating ability of the Cirrus HD OCT for glaucoma diagnosis will be determined by the ROC curves.

Eligibility criteria: Inclusion Criteria:

* Cooperative patients
* Repeated OCT data

Exclusion Criteria:

* Intraocular surgeries history
* DM
* High refractive error ( \< -4.00 diopters, or \> + 4.00 diopters)
* Media opacity

Primary outcomes:
measure: Retinal nerve fiber layer thickness
timeFrame: when the OCT images are taking
Secondary outcomes:
measure: Red-free fundus photo
timeFrame: when the OCT images are taking
measure: Visual field
timeFrame: when the OCT images are taking
measure: Intraocular pressure
timeFrame: when the OCT images are taking
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gong Je Seong
Study officials:
affiliation: Yonsei University
name: Gong Je Seong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04374578: Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes
Official title: Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes: A Multi-center Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes come to the clinic who want to use dulaglutide and never used dulaglutide before

Brief summary: Glycemic variability will be assessed using continuous glucose monitor(CGM) in type 2 diabetic patients who receive dulaglutide 1.5 mg/qw injection for 4 weeks.

Detailed description: Glycemic fluctuation is a major problem in glucose control in diabetic patients. It is interesting to know that whether weekly GLP-1RA can improve glycemic variability in diabetic patients. The present study aims to assess the effect of dulaglutide on glycemic variability using continuous glucose monitor(CGM) (Libra, Abbott) in type 2 diabetic patients with 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
* Meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
* 18 ≤ age ≤ 70 years old, male or female;

Exclusion Criteria:

* Subjects with Type 1 diabetes mellitus or secondary diabetes mellitus (i.e. any type other than T2DM)
* Personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (MEN2).
* History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones).
* History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function.
* Fasting triglyceride level more than 750 mg/dL at screening.
* Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/minute/1.73 meter\^2 (calculated using the Schwartz equation) at screening.
* ALT more than 2.5x upper limit of normal (ULN) or Bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin more than 35%) at screening.
* Use of a GLP-1receptor agonist at study entry and during the study.

Primary outcomes:
measure: Effect on glycemic variability
timeFrame: one months
Secondary outcomes:
measure: Effect on Glycemic Control
timeFrame: one months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Fudan University
name: Xiaoying Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05929378: A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Gilbert Type III Inguinal Hernia
Official title: A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP Surgery for Patients With Gilbert Type III Inguinal Hernia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Chronic Pain
Seroma
Recurrence
Infections
Hematoma
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Guang'an People's Hospital
name: Pengan County People's Hospital
name: People's Hospital of Yilong County
name: Nanbu Hospital of County Chinese Medicine
name: Nanchong Jialing District People's Hospital
name: Langzhong People's Hospital
name: Langzhong Traditional Chinese Medicine Hospital
First posted: 2023-07-03
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with type Ⅲ gilbert inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.


Eligibility criteria: Inclusion Criteria:

Unilateral indirect inguinal hernia according to preoperative physical examination and imaging examination.

The inclusion criteria were as follows: primary indirect inguinal hernia classified as Gilbert III (defect size diameter ≥3cm, including scrotal hernias)

Exclusion Criteria:

Age below 18 years or older than 80. Direct hernia, femoral hernia, recurrent hernia, incarcerated hernia, strangulated hernia, and other types of hernias.

Patients not suitable for general anesthesia. Patients requiring open surgery; patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.

Primary outcomes:
measure: recurrence
timeFrame: 6 months
measure: Postoperative pain
timeFrame: 6 months
Secondary outcomes:
measure: postoperative complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Yunhong Tian
state: Sichuan
Study officials:
References:
Clinical trial NCT02668978: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH
Official title: Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: LUNG DISEASES
Keywords: lung surgery
air leak
prevention
Lead sponsor: Quirón Madrid University Hospital
Sponsor class: OTHER
Collaborators: name: Baxter BioScience
First posted: 2016-01-29
Enrollment: 170
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: The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.

Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 years who are able to give their informed consent
* Patients undergoing lung resection surgery for either malignant or benign conditions including:

  * Lobar and sublobar resections
  * Open, video-assisted thoracoscopic or robotic surgeries
  * Diagnostic or therapeutic procedures

Exclusion Criteria:

* Traumatic pulmonary contusion or laceration
* Lung reduction surgery
* Planned removal of more than 10 lung lesions
* Pneumonectomy
* Known hypersensitivity to bovine protein
* Known hypersensitivity to Brilliant Blue FCF (E133)
* Presence of active infection

Primary outcomes:
measure: Duration of postoperative air leaks
timeFrame: Within first 30 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Pozuelo de Alarcón
country: Spain
facility: Quirónsalud Madrid University Hospital
state: Madrid
Study officials:
References: