louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06857331: Perioperative Analgesia With Erector Spinae Plane Block in Liver Transplant Recipients
Official title: Optimization of Perioperative Analgesia With Erector Spinae Plane Block During Major Abdominal Surgeries in Patients With Impaired Liver Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant
Erector Spina Plan Block
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if ESP block is safe and effective for perioperative analgesia in patients undergoing liver transplant. The main question it aims to answer are Is ESP block safe and has a minimum side effects, like hematoma? Is it effective for perioperative analgesia? Researchers will compare the results to a group of patients who underwent liver transplants without any regional anaesthesia techniques.

Participants will receive bilateral thoracic ESP block on the day of the transplantation with a subsequent bilateral catheterization.


Eligibility criteria: Inclusion Criteria:

* impaired liver function - cirrhosis or chronic liver disease with the development of hypocoagulation (APTT \> 35 sec, INR \> 1.5), thrombocytopenia, patients requiring major abdominal surgery, age \> 18 years, written consent to participate in the study was obtained

Exclusion Criteria:

* Platelet count \<50x109, failed ESP catheterization unilateral or bilateral, failed epidural anesthesia attempt, history of allergy or hypersensitivity to local anesthetics, hepatopulmonary syndrome, patients on mechanical ventilation before surgery, patients on CRRT before surgery, refusal to participate in the study

Primary outcomes:
measure: Pain reduction postoperative
timeFrame: from enrollment to the 2nd postoperative day
measure: Opioid reduction intraoperatively
timeFrame: from enrollment to the end of the operation
measure: Need for opioids postoperatively
timeFrame: from enrollment to the 2nd postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Universal Hospital Oberig
Study officials:
References:
Clinical trial NCT01381731: A Double-masked, Randomized, Placebo-controlled,Pilot Study of Diquafosol Tetrasodium in Subjects Following Photorefractive Keratectomy (PRK)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Photorefractive Keratectomy
Keywords: post PRK wound healing
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this trial are to:

* Assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus placebo following one week of treatment in subjects undergoing photorefractive keratectomy (PRK).
* Evaluate the potential of diquafosol to accelerate corneal wound healing/re-epithelialization following PRK.


Eligibility criteria: Inclusion Criteria:

* between age 18 - 45 years old
* candidate for bilateral PRK

Exclusion Criteria:

* dry eye disease
* any corneal pathologies
* previous corneal or intraocular surgeries

Primary outcomes:
measure: Healing time
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05306431: Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants
Official title: Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants in Patients Reporting With Non-vital Necrotic Pulp and Apical Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irreversible Pulpitis
Lead sponsor: Altamash Institute of Dental Medicine
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment .

Detailed description: This study will compare the antibacterial effectiveness of sodium hypochlorite and PHMB, to find out whether PHMB can be used as a substitute to NaOCL. Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity.

Eligibility criteria: Inclusion Criteria:

* • Patients aged 18 to 50 years

  * Both male and female patients
  * Periodontally healthy teeth as determined by Periodontal Probing
  * Patients with non-vital necrotic pulps as determined by Cold Test
  * Patients with acute apical periodontitis determined by history and clinical examination
  * Clinical Findings:

Visual: Carious tooth decay Occlusion: Hyperocclusion Pulp vitality test: Negative Periapical radiograph: Caries involving pulp space and PDL widening Percussion Test: Positive Palpation Test: Negative

• Single rooted teeth as determined radiographically

Exclusion Criteria:

* • Multirooted teeth

  * Teeth undergoing Re-endo treatments
  * Teeth with root fractures and/ non restorable determined by clinical and radiographic examination
  * Patients receiving antibiotic treatment in the past 3 months determined by history
  * Patient with Diabetes determined by history
  * Patient with history of smoking

Primary outcomes:
measure: Bacterial load assessed by culture
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Hira Danish
state: Sindh
Study officials:
References:
Clinical trial NCT03089931: Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis
Official title: Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Myelopathy Spondylosis
Low Back Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with cervical myelopathy and low back pain

Brief summary: Low back pain may be reduced after cervical spinal surgery

Detailed description: The improved back pain score after cervical spinal surgery would be higher than that after non-surgical treatment.

Eligibility criteria: Inclusion Criteria:

* all patients with cervical myelopathy and low back pain

Exclusion Criteria:

* previous surgery at the lumbar spine
* malignancy
* previous surgery at the cervical spine

Primary outcomes:
measure: Low back pain
timeFrame: postoperative 6 months
measure: functional outcome
timeFrame: postoperative 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
Study officials:
References:
Clinical trial NCT03628131: Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
Official title: Safety and Efficacy of Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed Pediatric Solid Tumor
Refractory Pediatric Solid Tumor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2018-08-14
Enrollment: 46
Sex: ALL
Minimum age (years): 2
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor


Eligibility criteria: Inclusion Criteria:

* Patients with refractory/relapsed solid tumor (Stable or progressive disease after 1st-line treatment or relapse)
* Patients previously enrolled to "Genomic diagnosis of pediatric tumors by NGS (IRB No. SMC 2015-11-053)"

Exclusion Criteria:

* Patients who had high-dose chemotherapy and autologous stem cell transplantation previously
* Patients with organ dysfunction as follows (creatinine elevation ≥ 1.5 x upper limit of normal (ULN), ejection fraction \<40%, significant arrhythmia or conduction disturbance)
* Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
* Patients with active bleeding
* Patients who are taking strong CYP3A4 inhibitors, QTc-prolonging drugs, antithrombotic agents, or anti-platelet agents
* Pregnant or nursing women
* Patients who can not swallow the pill

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy
timeFrame: 42 days
Secondary outcomes:
measure: Rate of tumor response (neuroblastoma)
timeFrame: 4 weeks
measure: Rate of tumor response (brain tumor)
timeFrame: 4 weeks
measure: Rate of tumor response (other solid tumors)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Ki Woong Sung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214331: Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
Official title: Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2005-09-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who are prescribed antibiotics as part of their clinical care

Brief summary: This protocol is a prospective, open-label, multicenter, population pharmacokinetic and pharmacodynamic study of selected anti-infective agents in pregnant women being treated for suspected or documented infections.


Eligibility criteria: Inclusion Criteria:

* Women in their second or third trimester of pregnancy
* Women currently receiving treatment or whose physician has made the decision to start treatment with ciprofloxacin, azithromycin or gentamicin for a suspected or documented infection
* Of childbearing potential and who either have never been pregnant or whose most recent pregnancy ended 3 months previously (control group)
* Women greater than 3 months postpartum and currently breast-feeding (substudy)

Exclusion Criteria:

* Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Gloria Sarto, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04436731: Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
Official title: Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Obesity
Healthy
Vasoconstriction
Vasodilation
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. This project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.


Eligibility criteria: Inclusion Criteria:

* 18-45 years of age (premenopausal)
* Healthy weight (BMI ≥18 and ≤25 kg/m2)
* Obese (BMI ≥30 kg/m2)

Exclusion Criteria:

* Pregnancy, breastfeeding, oral hormonal contraceptive use
* Diagnosed sleep apnea or Oxygen desaturation index \>10 events/hr
* Current smoking/Nicotine use
* Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes, Polycystic ovarian syndrome
* Communication barriers
* Prescription medications, Sensitivity to lidocaine

Primary outcomes:
measure: Change in forearm vascular conductance with intra-arterial drug infusion
timeFrame: Continuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia).
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
References:
Clinical trial NCT03206931: Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion
Official title: Expanded Access to Provide Selitrectinib (BAY2731954) for the Treatment of Cancers With a NTRK Gene Fusion.
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Solid Tumors Harboring NTRK Fusion
Keywords: Metastatic cancer
Advanced cancer
Neurotrophic tyrosine receptor kinase (NTRK)
NTRK1
NTRK2
NTRK3
Fusion Positive
Children
Loxo-195
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-07-02
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Selitrectinib expanded access is for minor and adult patients with cancer having a change in a particular gene (NTRK1, NTRK2, or NTRK3 gene fusion). The patients are ineligible for an ongoing selitrectinib clinical trial or have other considerations that prevent access to selitrectinib through an existing clinical trial. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion, including blood cancers, who have previously received tropomyosin receptor kinase (TRK) inhibitor therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer with a NTRK1, NTRK2, and NTRK3 gene fusion
* Previous treatment with a kinase inhibitor with known activity on TRK inhibition
* Unable to participate in an ongoing selitrectinib clinical trial
* Medically suitable for treatment with selitrectinib

Exclusion Criteria:

* Currently enrolled in an ongoing clinical study with a TRK inhibitor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00699231: Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
Official title: Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Keywords: Hepatitis B
Engerix™-B
Recombinant hepatitis B vaccine
Adjuvant
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B

Detailed description: At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility criteria: Inclusion Criteria:

* Dialysis patients
* A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
* Age: from 18 years onwards
* Seronegative for anti- hepatitis antibodies

Exclusion Criteria:

* History of persistent hepatic, cardiac or respiratory disease
* Any acute disease at the moment of entry into the study
* Chronic alcohol consumption
* Hepatomegaly, right upper quadrant pain or tenderness
* Any treatment with coticosteroids or immunomodulating drugs
* Known hypersensitivity to any component of the vaccine
* Simultaneous participation in any other clinical trial

Primary outcomes:
measure: Occurrence and intensity of solicited local and general symptoms
timeFrame: 4-day follow-up period after each vaccination
measure: Occurrence of unsolicited adverse events
timeFrame: During the course of the study
measure: Occurrence of serious adverse events
timeFrame: During the course of the study
measure: Anti-HBs antibody concentrations
timeFrame: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04937231: Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients
Official title: Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Aerobic Exercises
Resistance Training
Combined Training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 92
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the effectiveness of aerobic training and resistance training and combined training on heart failure patients.


Eligibility criteria: Inclusion Criteria:

* Heart failure patients with ejection fraction greater than 35%

Exclusion Criteria:

* Patients with unstable angina
* Patients who had severe pain in the lower limbs
* Patients with Blood pressure greater than 190/120mmHg were excluded
* Patients who had positive contraindication for cardiac rehabilitation were not admitted in this study

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 4th week
measure: Minnesota living with heart failure questionnaire
timeFrame: 4th week
measure: 6 Min walk test (Distance in meters)
timeFrame: 4th Week
measure: Peak VO2 with formula
timeFrame: 4th Week
measure: Heart Rate/Pulse Rate
timeFrame: 4th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rawalpindi Institute of Cardiology
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05290831: Changes in Heart Rate Variability And Heart Rate/Activity Slope After Hospitalization for Acute Exacerbations of COPD
Official title: Changes in Heart Rate Variability And Heart Rate/Activity Slope Measures After Hospitalization for Acute Exacerbations of COPD: An Observational Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2022-03-22
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to observe the variation in time between heart beats and how heart rate changes during activity evolve after hospitalization for an exacerbation of COPD.

Detailed description: The investigators will place a monitoring patch that continuously records electrocardiogram and activity. Participants will switch this patch every 7 days for a total of 28 days. From these data the investigators will observe how heart rate variability and heart rate responses to exercise evolve after hospitalization for an exacerbation of COPD.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. At least moderate COPD by Global Initiative for Chronic Obstructive Lung Disease spirometry criteria (FEV1/FVC \< 0.7 and FEV1 \< 80% predicted)
3. 10 pack year smoking history
4. Hospitalized with one or more of:

   1. increased dyspnea
   2. increased sputum
   3. change in sputum character
5. Treated with corticosteroids and/or antibiotics for respiratory indications
6. Age \> 40 years old

Exclusion Criteria:

1. Discharging home on hospice
2. Inability to follow trial protocols
3. Pacemaker
4. Allergy to a component of the adhesive patches
5. Breastfeeding
6. Permanent/continuous atrial fibrillation

Primary outcomes:
measure: Model fit from repeated measures mixed model of heart rate/activity slope
timeFrame: 28 days
measure: Heart rate variability slopes (time and frequency-domain)
timeFrame: 28 days
Secondary outcomes:
measure: Comparison of heart rate/activity slope in participants readmitted vs not-readmitted
timeFrame: 28 days
measure: Comparison of heart rate variability slope in participants readmitted vs not-readmitted
timeFrame: 28 days
measure: Acceptability to participants
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: David MacDonald, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: