louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01321684: The Effect of Spinal Flexion in the Lateral Decubitus Position on the Unilaterality During Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: For unilateral spinal block, spinal local anesthetics should take effect on the spinal nerves of one side. With full flexion of the spine, the cauda equina becomes tightened and hangs in the middle of the subarachnoid space. This study was performed to assess if flexion of the vertebral column facilitates unilateral spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA physical status Ⅰ-Ⅱ, scheduled for elective knee arthroscopy under spinal anesthesia

Exclusion Criteria:

* Hemodynamically unstable patients
* Lumbar disease
* patients with back pain

Primary outcomes:
measure: Time for the complete regression of pinprick spinal analgesia on the nondependent legs
timeFrame: Sensory and motor blockade were evaluated within 3 hour of intrathecal injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT04302584: Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock
Official title: Comparison of Between Norepinephrine Alone Versus Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Acute Kidney Injury
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although norepinephrine is commonly used and is the recommended agent for the treatment of hypotension in volume-resuscitated hyperdynamic septic shock, Low doses of vasopressin may be added to norepinephrine to maintain arterial blood pressure in refractory septic shock and to decrease exposure to norepinephrine. The aim of the work is to compare the effect of norepinephrine alone and Norepinephrine/vasopressin combination on hemodynamics and tissue perfusion in septic shock patients.

Detailed description: Study which was performed on 90 adult of either sex in intensive care unit who developed septic shock.45 patients in each group according to the drugs used, by the single blind technique as the treating physician only is aware of the drugs used.

Group 1: patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min).

Group 2: patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min).

A comparison was done between both groups as regard:Hemodynamics,Tissue perfusion, C-Reactive Protein (mg/L) ,WBC, UREA (mg/dL),CREATININE (mg/dl), NGAL (Neutrophil gelatinase associated Lipocalin) (ng/ml). Comparison was done at baseline, then every 6 hours for 48 h as regard hemodynamics and tissue perfusion, and at base line then, 24 h and 48 h as regard sepsis biomarkers and renal biomarkers.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years of both sex

Exclusion Criteria

* Patients with renal impairment (Creatinine\>2mg/dl)
* Sever Heart Disease (ischemic/valvular)
* Peripheral vascular disease (e.g. Raynaud's phenomenon)

Primary outcomes:
measure: Lactate Level Lactate level • (central venous oxygen saturation)SVO2
timeFrame: 48 hours
measure: Scvo2
timeFrame: 48 hours
Secondary outcomes:
measure: NGAL, NGAL NGAL
timeFrame: 48 hours
measure: Mortality
timeFrame: 28 days
measure: CRP
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa El Gendy
state: Ain Shams University Specialized Hospital
Study officials:
References:
Clinical trial NCT06577584: Comparison of Diabetes Patients - Care Trajectory Versus Convention
Official title: The Profile of People with Diabetes Followed Up in the Context of the Care Trajectory Versus the Diabetes Convention
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: T2DM patients being followed up in the Diabetes Care Trajectory or in the Diabetes Convention (group B) in Belgium

Brief summary: In Belgium, various structures and reimbursement programs are in place for managing Type 2 Diabetes Mellitus (T2DM). The Diabetes Care Trajectory is primarily utilized for patients who require a maximum of two insulin injections per day. In contrast, patients needing multiple daily insulin injections are managed under a diabetes convention program.

The Diabetes Care Trajectory has been operational since 2009. However, unlike patients in the diabetes convention program, where the profile and quality of care are regularly audited, there is limited information available regarding the profile and outcomes of patients within the Care Trajectory. This retrospective study aims to compare the profiles, including complications and quality of care, of T2DM patients across both groups.

Detailed description: This retrospective study will collect data from T2DM patients enrolled in either the Diabetes Care Trajectory or the diabetes convention program. The data gathered will encompass quality of care, clinical status, complications, and metabolic state.

The profiles of these patient populations will be compared cross-sectionally for each year within the study period (2009-2024). Additionally, a longitudinal analysis will be conducted to examine the evolution of these profiles over the entire study period. Data will be extracted from electronic case records maintained at participating sites across Belgium.

Eligibility criteria: Inclusion Criteria:

* Followed in one of the NexusHealth hospitals in Belgium: https://www.nexuzhealth.com/en/why-nexuzhealth/patients/affiliated-healthcare-institutions
* Having being diagnosed with type 2 diabetes mellitus
* Followed in the Diabetes Care Trajectory or in the Diabetes Convention (group B) in Belgium Exclusion Criteria: no specific exclusion criteria

Primary outcomes:
measure: HbA1c
timeFrame: Yearly for the entire study period (2009 - 2024)
Secondary outcomes:
measure: Complications of diabetes
timeFrame: Yearly for the entire study period (2009 - 2024)
measure: Cholesterol profile
timeFrame: Yearly for the entire study period (2009 - 2024)
measure: Insulin requirements
timeFrame: Yearly for the entire study period (2009 - 2024)
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Chantal Mathieu, MD,pHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04708184: A Study to Assess Relative Bioavailability of and Effect of Food on a New Oral Tablet Formulation of GLPG3970
Official title: A Randomized, Open-label, 3-period, Single-dose, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of GLPG3970 Given as an Oral Tablet Formulation Versus the Oral Solution Formulation of GLPG3970 and to Assess the Effect of Food on the Oral Tablet Formulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study to assess the relative bioavailability of a GLPG3970 oral tablet formulation compared to an oral solution formulation and the effect of food on the bioavailability of a single dose of the oral tablet formulation of GLPG3970. It will also evaluate the safety and tolerability of a single dose of GLPG3970.


Eligibility criteria: Inclusion Criteria:

* Male or female subject between 18 and 55 years of age (extremes included), on the date of signing the informed consent form .
* A body mass index between 18.0 and 30.0 kg/m2, inclusive.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Total bilirubin, aspartate aminotransferase, and alanine aminotransferase must be no greater than 1.5x upper limit of normal range. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.

This list only contains the key exclusion criterion.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of GLPG3970
timeFrame: Between Day 1 pre-dose and Day 4
measure: Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
timeFrame: Between Day 1 pre-dose and Day 4
measure: Area under the plasma concentration-time curve from time zero until the last observed quantifiable concentration (AUC0-t)
timeFrame: Between Day 1 pre-dose and Day 4
Secondary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
timeFrame: From Day 1 through study completion, an average of 1 month
Other outcomes:
Locations:
city: Rennes
country: France
facility: Biotral Rennes
Study officials:
affiliation: Galapagos NV
name: Ekaterina Tankisheva, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05701384: Lazertinib 160mg in EGFR T790M NSCLC
Official title: A Phase II Study for the Evaluation of the Feasibility of Lazertinib 160mg Per Day in Patients With EGFR T790M Mutant Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer Stage IV
EGFR T790M
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 117
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of 160mg lazertinib.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed non-small cell lung cancer
* Patients in a palliative setting who is not applicable for the curative treatment
* EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI
* Confirmed EGFR T790M mutation after the previous EGFR TKI
* Available to receive lazertinib either as po or vis levine tube
* Willing to participate clinical trial
* Age over or equal to 19
* ECOG PS 0 to 2

Exclusion Criteria:

* Previously received 3rd generation EGFR TKI
* No clinical benefit is expected based on the investigator's decision
* Uncontrolled symptomatic CNS metastases
* Uncontrolled systemic disease

Primary outcomes:
measure: The dose reduction or treatment discontinuation rate
timeFrame: Total 24 months of study period
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: MA
Study officials:
References:
Clinical trial NCT02260284: The Effect of Acupuncture in Treating Chronic Low-back Pain
Official title: The Effect of Acupuncture in Treating Chronic Low-back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankylosing Spondylitis
Low Back Pain
Lead sponsor: Chengdu PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain

Detailed description: We want to know if the Yaotong points penetration or standardized acupuncture mode are more effective than medical care alone for CLBP; and if Yaotong points penetration is more effective than standardized acupuncture.

Eligibility criteria: Inclusion Criteria:

* with CLBP
* without taking any other medication for the treatment of CLBP in at least 2 last weeks;
* aged from 18 to 50 years;
* without conflict to the written, informed consent signed prior to the enrollment.

Exclusion Criteria:

* pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis and infections);
* complicated back problems (such as scoliologic \>40° curvature, chronic spondylitis, sciatica, prior back surgery and other medicolegal issues);
* with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation disfunctions, being in pregnancy, seizure disorder);
* conditions making treatment difficult (e.g., paralysis, psychoses);
* conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers);
* previous acupuncture treatment for any condition.

Primary outcomes:
measure: Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
timeFrame: at 0 week, 12 weeks, 24 weeks
Secondary outcomes:
measure: Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks
timeFrame: at 0 week, 12 weeks, 24 weeks
measure: Changes from baseline on short-form 36 health survey (SF-36)
timeFrame: at 0 week, 12 weeks, 24 weeks
measure: Changes from baseline on Visual Analog Scale at 24 weeks
timeFrame: at 0 week, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: General Hospital of Chengdu Military Area Command PLA
state: Sichuan
Study officials:
References:
citation: Luo Y, Yang M, Liu T, Zhong X, Tang W, Guo M, Hu Y. Effect of hand-ear acupuncture on chronic low-back pain: a randomized controlled trial. J Tradit Chin Med. 2019 Aug;39(4):587-598.
Clinical trial NCT06853184: Study Evaluating the Efficacy and Safety of Artesunate
Official title: Phase 2, Randomized, Open-label, Active Comparator, Dose-ranging Study Evaluating the Efficacy and Safety of Artesunate for Injection in Combination With Ganciclovir or Valganciclovir for the Treatment of Cytomegalovirus Infection in Solid Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: CMV Infection
Keywords: CMV infection
Lead sponsor: Amivas Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-28
Enrollment: 90
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: This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy and SOC treatment in SOT recipients with clinically significant CMV infection.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Recipient of a solid organ transplant (kidney, lung, heart, or liver)
* Have a documented CMV infection
* Have CMV DNAemia
* Require IV GCV or oral VGCV
* Be washed out from any anti-CMV antiviral drugs
* Have all the following results as part of screening laboratory assessments
* Have life expectancy of ≥ 12 weeks
* Be willing and have an understanding and ability to fully comply with the study
* If female use birth control

Exclusion Criteria:

* Have taken IV GCV or oral VGC daily for \>8 days
* Have refractory CMV infection or disease
* Have CMV antiviral drug resistance
* Have a known hypersensitivity to artesunate, GCV, or VGCV
* Pregnant (or expecting to conceive) or nursing
* Have severe liver disease
* Require ongoing treatment with or an anticipated need for treatment with drugs with known interactions with artesunate or GCV
* Taking any another investigational drug with anti-CMV activity

Primary outcomes:
measure: Reduction of cytomegalovirus (CMV) DNAemia
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04307784: The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control
Official title: The Effects of Vitamin D3 Supplementation Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control; A Randomized Controlled Trial in People With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D Deficiency
vitamin D3
omega-3 fatty acids
glycated Hemoglubine
C-peptide
Insulin resistance
VD3
A1C
HbA1C
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 115
Sex: ALL
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The Effects of Vitamin D3 alone and in a combination with omega-3 on the association of C-peptide with glycemic control

Detailed description: The data bout the effects of Vitamin D3 (VD3) alone and as a combination with omega-3 fatty acids (Omega-3FA) on the association between C-peptide (CP) and the glycated hemoglobin (HbA1c) is scarce, conflicting and nothing published in the literature review on the combined effect of VD3 and Omega-3FA as a combination on the association of CP with glycemic control.

This study will be conducted to investigate the effects of (VD3) alone and as a combination with Omega-3FA on the association between CP as an insulin secretion marker, and glycemic control parameters represented by glycated Hemoglobin (HbA1c), on people with vitamin D deficiency (VDD).

This randomized, placebo-controlled trial is designed to test the effects of (50,000 IU VD3/ weekly) and (300mg omega-3FA/daily) separately and as a combination for eight weeks, on the serum levels of CP, 25-hydroxy vitamin D (25OHD) and HbA1c. this study will be carried out during winter on 120 healthy Jordanian males and females with VDD with age range (25-50) years. Fasting serum levels for 25OHD, CP, HbA1c, PTH, Calcium, Phosphate, ALT (Alanine aminotransferase) and Urea were assessed at baseline and at the end of the trial.

Eligibility criteria: Inclusion Criteria:

* Aged (30-64)
* Have a medical diagnosis of VDD

Exclusion Criteria:

* Chronic diseases, such as (osteoporosis, cancer, kidney disease(due to the association between prolonged administration of VD3 and kidney stones formation), an endocrine disorder, thalassemia).
* Documented history of allergic reactions to Omega-3FA supplementations

Primary outcomes:
measure: Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C
timeFrame: 8 weeks
Secondary outcomes:
measure: Plasma Concentration of PTH and Calcium
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Applied Science University
Study officials:
affiliation: Applied Science Private University (ASU)
name: Mahmoud S Abu-samak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06841484: Comparison of Full Robotic Instrumentation and Assistant-Controlled Laparoscopic Instrumentation in Robotic Distal Gastrectomy
Official title: Clinical Outcomes of Full Robotic Instrumentation Versus Assistant Controlled Laparoscopic Instrumentatin in Robotic Distal Gastrectomy: Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blind Randomized controlled
Primary purpose: TREATMENT

Brief summary: This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes.


Eligibility criteria: Inclusion Criteria:

1. Patients with histologically confirmed gastric adenocarcinoma prior to surgery.
2. Patients who have undergone a complete (R0) resection.
3. Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
4. Patients undergoing robotic radical distal gastrectomy.

Exclusion Criteria:

1. Patients under 19 years of age.
2. Patients who have received preoperative chemotherapy or radiotherapy.
3. Patients diagnosed with stage IV gastric cancer due to distant metastasis.
4. Patients diagnosed with malignancies other than gastric cancer.
5. Patients scheduled to undergo total gastrectomy.
6. Patients requiring total omentectomy.

Primary outcomes:
measure: Average operative time (in minutes).
timeFrame: At the end of the surgery
Secondary outcomes:
measure: Total cost of consumable surgical materials.
timeFrame: At the end of the surgery (up to 12 hours)
measure: Quality of Recovery (QoR-15) scores at 72 hours postoperatively.
timeFrame: 72 hours postoperatively
measure: Time to first flatus and bowel movement.
timeFrame: Up to 1 month after surgery
measure: Postoperative laboratory markers (e.g., CRP, WBC).
timeFrame: Up to 5 days after surgery
measure: Incidence of postoperative complications.
timeFrame: Within 30 days postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeveranceHospital
Study officials:
References: