louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00872352: Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients
Official title: Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Myeloma
Peripheral Neuropathy
Keywords: Multiple Myeloma
Bortezomib
Peripheral Neuropathy
evaluation
evaluation of electrophysiological changes related to the dose and time of bortezomib administration
investigation of correlation between the incidence of BIPN and the subtype of myeloma
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the present study we are planning to study electrophysiological changes related to the dose and time of bortezomib administration in newly diagnosed patients with MM, during the first months of treatment and 6 months after ending. In addition a possible correlation between the incidence of BIPN and the subtype of myeloma and other risk factors will be investigated.


Eligibility criteria: Inclusion Criteria:

* Age\> 18
* Patients with Multiple Myeloma stage II, III (Durie and Salmon staging) prior to Bortezomib Therapy
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Be willing and able to comply with the protocol treatment for the duration of the study
* Patient's written informed consent

Exclusion Criteria:

* Multiple Myeloma on progression
* Incidence of Relapsed or Refractory Myeloma
* Patients with the existing neuropathy at the time of the diagnosis

Primary outcomes:
measure: A dose-related neurotoxic effect of bortezomib will be determined through regression analysis with the change in TNSr as the dependent variable Bortezomib doses will use as independent variables.
timeFrame: 3 months
Secondary outcomes:
measure: To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy
timeFrame: 4 months
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson MC
Study officials:
affiliation: Head of Hematology, Wolfson MC, Holon, Israel
name: Eliezer Rachmilewitz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01449552: Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After TKA: A Prospective RCT
Official title: Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Total knee arthroplasty (TKA) may be associated with significant blood loss, and transfusion carries substantial risk of immunologic reaction and disease transmission. Several methods reportedly reduce postoperative blood loss and avoid homologous blood transfusion with traditional TKA approaches. Drain clamping was one of the widely used method and tranexamic acid administration was the recently adjuvant method to reduce blood loss in TKA. However, there were several regimens in either drain clamping or tranexamic acid administration reported in previous studies. Our objective was to compare the efficacy of our drain clamping protocol and/or tranexamic acid regimen for reducing blood loss and transfusion in TKA.


Eligibility criteria: Inclusion Criteria:

* The patients younger than 85 years with knee osteoarthritis

Exclusion Criteria:

* The patient diagnosed secondary osteoarthritis (eg, rheumatoid arthritis, posttraumatic arthritis, gouty arthritis, postseptic arthritis)
* High-risk medical comorbid patient
* The patient who was planed for simultaneous bilateral TKAs
* The patient who had history of thromboembolic disease or bleeding disorder
* The patient who was receiving anticoagulant drug treatment
* The patient who had allergy to tranexamic acid

Primary outcomes:
measure: Postoperative blood loss
timeFrame: 48 hours after operation
Secondary outcomes:
measure: Number of blood transfusion
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Keerati Charoencholvanich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chareancholvanich K, Siriwattanasakul P, Narkbunnam R, Pornrattanamaneewong C. Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2012 Jul 20;13:124. doi: 10.1186/1471-2474-13-124.
Clinical trial NCT04018352: Assessment of Variations of The Number of Roots &Amp; Root Canal Configurations of Maxillary Premolars and Their Relation to the Floor of the Maxillary Sinus
Official title: Assessment of Variations of The Number of Roots &Amp; Root Canal Configurations of Maxillary Premolars and Their Relation to the Floor of the Maxillary Sinus in a Sample of Egyptian Population Using CBCT: An Observational Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Root Canal Configurations of Permanent Maxillary Premolars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 114
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian Population

Brief summary: Assessment of Variations of The Number of Roots \&amp; Root Canal Configurations of Permanent Maxillary Premolars and their Relation to the Floor of the Maxillary sinus

Detailed description: Assessment of Variations of The Number of Roots \&amp; Root Canal Configurations of Permanent Maxillary Premolars and their Relation to the Floor of the Maxillary sinus in a Sample of Egyptian Population using CBCT: An Observational Cross-Sectional Study

Eligibility criteria: Inclusion Criteria:

* Fully maturated and erupted maxillary permanent premolars of Egyptian patients, males or females.
* Intact maxillary premolars' roots without fractures or cracks.
* Maxillary Premolars without posts or previous root canal treatment.
* CBCT scans of different fields of view could be included as long as it shows maxillary premolars.
* CBCT scans of 0.2 mm voxel resolution {the maximum voxel size accepted for endodontic imaging}

Exclusion Criteria:

* Maxillary premolars with:

Developmental anomalies. External or internal root resorption. Root canal calcification. Previous root canal treatment Post restorations. Root caries especially reaching the bifurcation area.

* Evidence of apicectomy or periapical surgery
* CBCT images of poor quality or artifacts interfering with the assessment of the root canals.

Primary outcomes:
measure: Number of roots maxillary premolars
timeFrame: up to 2020
Secondary outcomes:
measure: Assessment of the relationship between maxillary premolars roots and the maxillary sinus floor
timeFrame: up to 2020
Other outcomes:
measure: Number of root canals
timeFrame: up to 2020
measure: Root canals configuration
timeFrame: up to 2020
Locations:
Study officials:
References:
Clinical trial NCT03253952: A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.
Official title: PROSPECT ADDITION SCI - A PROSPECTive Study of Autonomic Dynamic Dysfunction to Predict infecTIONs After Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Trauma, Spinal Cord
SPINAL Fracture
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SCI patients (n=50 subjects), Isolated Spinal fracture patients (n=10)

Brief summary: The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal instability) that develop after SCI have value in predicting SCI-associated infections (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in both the time and frequency domains to discriminate between the relative contribution of sympathetic and parasympathetic innervation to changes in HRV. The ability to predict infections will enable novel treatments thereby reducing infection-associated mortality and improving neurological and functional outcomes.


Eligibility criteria: Inclusion Criteria:

1. Patients with acute isolated spinal cord injury (AIS A-D) planned for surgical stabilization and decompression, lesion may include more than 1 segment
2. Patients with acute isolated spinal fracture, lesion may include more than 1 segment
3. Legal age of the patient
4. Documented informed consent of the patient

Exclusion Criteria:

1. Non-traumatic spinal cord injury
2. Concomitant traumatic brain injury (TBI) (definition: i) patient with severe TBI (Glasgow Coma Scale ≤ 8) and ii) patients with intracranial pressure monitoring sensors)
3. Neoplasia and/or antineoplastic therapy
4. Pregnancy, lactation

Primary outcomes:
measure: Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections
timeFrame: At all study time-points for a period of 24hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jan M Schwab, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06389552: Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients
Official title: A Long-term Follow-up Study of FOLFIRINOX Regimen as Adjuvant Therapy in Pancreatic Cancer Patients After Curative Surgery: Multi-center, Prospective
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adjuvant Chemotherapy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 110

Brief summary: This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery.

Detailed description: This study is multi-center, prospective, long-term follow-up observational study.

Eligibility criteria: Inclusion Criteria:

* Age over 19 at the time of obtaining the informed consent form
* Planning to FOLFIRINOX as adjuvant therapy after pancreatic cancer surgery
* ECOG 0 or 1
* Scheduled to RO or R1 resection
* Organ function capable of chemotherapy

Exclusion Criteria:

* FOLFIRINOX contraindications among the drug approval requirements
* Palliative Therapy
* Experienced toxic reactions or Hypersensitivity reactions of FOLFIRINOX

Primary outcomes:
measure: Disease-free survival
timeFrame: Day 1 to Week 88
Secondary outcomes:
measure: Overall survival
timeFrame: Day 1 to Week 88
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul ST. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Myung-Ah Lee
role: STUDY_CHAIR
References:
Clinical trial NCT04995952: Comparsion of Gross Motor Task Training and Trunk Trageted Training
Official title: Comparison Of Gross Motor Task Training And Trunk Targeted Training On Balance, Range Of Motion And Community Participation In Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral plasy
Trunk targeted training
Gross motor trageted training
Balance
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study trunk, targeted training and gross motor function training were compared their effect on functional status, range of motion, and community participation of cerebral palsy children

Detailed description: In this project a randomized clinical trial was be conducted to determine the comparison of gross motor training technique and trunk training therapy on balance, Range of motion and community participation in children with diplegic cerebral palsy. This study aim to compare the effects of both the treatments to improve balance, quality of life and community participation. The sample was being collected according to inclusion and exclusion criteria using a convenient sampling technique within period of 6 months. The participants were be randomly allocated in two groups' .Group A received gross motor training which included sit to stand, step up and walking for 1 hour/day/3 days a week for 3 months. Group B received trunk targeted training for 1 hour/day/3 days a week for 3 months which included treadmill walking, reaching forward to the limits of stability and specific truncal activities with vibration and proprioception. The post treatment assessments was done via early assessment of balance, goniometer, and functional mobility assessment

Eligibility criteria: Inclusion Criteria male \& female.

* GMFCS III V
* Age 8to12 years
* Diplegic cerebral palsy
* Hypoxic brain injury
* Diagnosed with a gross motor delay by the pediatrician.

Exclusion Criteria:

* Children having a cognitive or psychiatric disorder.
* Children with known congenital limb anomaly
* Children with some chromosomal defect

Primary outcomes:
measure: Functional mobility assessment
timeFrame: 10 minutes
measure: Pediatric Berg Balance Scale
timeFrame: 20 minutes
measure: Goniometer
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Prof S Shakil Ur Rehman, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT00720252: Can Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?
Official title: Can Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fetal Lung Maturity
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to measure prenatally with ultrasound the intratracheal flow volume displaced during breathing cycle in premature fetuses and to check whether a relationship exists between the inspired fluid and fetal lung maturation.


Eligibility criteria: Inclusion Criteria:

* Women delivering between 27 to 37 weeks.
* Women undergoing amniocentesis for determining fetal lung maturity between 27 to 37 weeks.

Exclusion Criteria:

* Major fetal malformation.
* Oligohydramnios or rupture of membranes diagnosed before 24 weeks of gestation.

Primary outcomes:
measure: To check whether a threshold exists between peak velocity and/or volume of fluid inspired by the fetus and lung maturation.
timeFrame: end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Dep. OB/GYN, HaEmek Medical Center
Study officials:
References:
citation: Kitterman JA. Fetal lung development. J Dev Physiol. 1984 Feb;6(1):67-82. No abstract available.
citation: Kalache KD, Chaoui R, Bollmann R. Doppler assessment of tracheal and nasal fluid flow during fetal breathing movements: preliminary observations. Ultrasound Obstet Gynecol. 1997 Apr;9(4):257-61. doi: 10.1046/j.1469-0705.1997.09040257.x.
Clinical trial NCT03250052: A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
Official title: A Phase I Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Fimasartan
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 39
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.

Detailed description: This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.

Eligibility criteria: 1. Inclusion Criteria (Total: 5):

1. 19-50 year-old healthy male.
2. 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2
3. Subject who has no clinically significant medical history.
4. Subject whose informed consent is obtained and who is willing to comply with protocol.

2. Exclusion Criteria (Total: 19):

1. Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or \< 115mmHg / Sitting Diastolic blood pressure(SiDBP) ≥ 90mmHg or \< 70mmHg
2. Upper Limits of Normal x 1.5 \< Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin
3. Creatinine clearance(CrCl) \< 80mL/min (using Cockcroft-Gault formula)
4. Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL)
5. Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).

Primary outcomes:
measure: [Part A] AUC of fimasartan
timeFrame: 0~24 hour after drug administration
measure: [Part A] Cmax of fimasartan
timeFrame: 0~24 hour after drug administration
measure: [Part B] AUC of Linagliptin
timeFrame: 0~24 hour after drug administration
measure: [Part B] Cmax of linagliptin
timeFrame: 0~24 hour after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Young-Ran Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang WY, Lee HW, Gwon MR, Cho S, Shim WS, Lee KT, Yang DH, Seong SJ, Yoon YR. A Pharmacokinetic Drug Interaction Between Fimasartan and Linagliptin in Healthy Volunteers. Drug Des Devel Ther. 2020 May 26;14:2101-2111. doi: 10.2147/DDDT.S248205. eCollection 2020.
Clinical trial NCT04157452: Prediction of Sepsis After Flexible Ureteroscopy
Official title: Prediction of Sepsis After Flexible Ureteroscopy in Patients With Proximal Ureteral Stone by Using Preoperative Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urolithiasis
Sepsis
Surgery--Complications
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients are enrolled in Wuhan Tongji Hospital from January 2012 to December 2018. Patient data is collected from institutional medical record archives.

Brief summary: Sepsis is a lethal complication of flexible ureteroscopy. The aim of this study is to identify predictors of sepsis after flexible ureteroscopy in patients with solitary proximal ureteral stones.


Eligibility criteria: Inclusion Criteria:

* history of fURS to treat unilateral, solitary, and proximal ureteral stones
* age ≥18 years

Exclusion Criteria:

* anatomical renal abnormalities such as transplant kidney, solitary kidney, horseshoe kidney, and kidney duplication

Primary outcomes:
measure: complication-sepsis
timeFrame: within 48 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00416052: Relation Between Bone Density and the Regulation of Mineral Metabolism in Renal Stone Formers
Official title: Relation Between Bone Mineral Density and the Regulation of Mineral Metabolism in Renal Stone Formers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Calcium Nephrolithiasis
Keywords: calcium
calciuria
PTH
1,25-vitamin D
Calcitriol
bone mineral density
osteodensitometry
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2006-12-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recurrent renal calcium stone formers

Brief summary: Accumulating evidence indicated that renal calcium stone formers often exhibit a low bone density. Therefore we want to test the hypothesis, that the mineral (calcium) metabolism is differently regulated in calcium stone formers with low as opposed to high bone density.

Detailed description: There is epidemiological evidence associating renal calcium stones and decreased bone mineral density (BMD). The decreased BMD in calcium stone formers is linked to hypercalciuria and both subtypes, fasting as well as absorptive hypercalciuria are associated with a diminished BMD. Higher 1,25-vitamin D plasma concentrations and lower PTH levels are encountered under free-choice diet conditions in patients diagnosed with absorptive and fasting hypercalciuria when compared to normocalciuric stone formers. Reports studying the BMD of stone formers and its link with mineral metabolism variables and urinary calcium excretion under different calcium intakes are rare.

We hypothesize now that PTH and 1,25-vitamin D change differently when calcium stone formers with high, intermediate and low BMD are challenged by a low calcium diet.

Eligibility criteria: Inclusion Criteria:

* passage of at least one calcium containing kidney stone

Exclusion Criteria:

* established cause of calcium stone formation (sarcoidosis, primary hyperparathyroidism etc.)
* creatinine clearance \< 60 ml/min
* urinary tract infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dept. Nephrology & Hypertension, Univ. Hospital Bern
Study officials:
affiliation: University of Bern
name: Felix J Frey, MD
role: STUDY_DIRECTOR
References: