louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01148108: Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma
Official title: Phase 2 Study of Canfosfamide HCl for Injection (Telcyta®, TLK286)in Refractory or Relapsed Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma (DLBCL) and Multiple Myeloma (MM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
B Cell Lymphoma
Multiple Myeloma
Keywords: NHL
Non-Hodgkins Lymphoma
Lymphoma
Mantle Cell
Diffuse Large B Cell
Multiple Myeloma
Telcyta
canfosfamide
TLK286
Prodrug
Enzyme activated drug
Glutathione Transferase P1-1 activated drug
GSTp1-1 activated drug
Glutathione Transferase activated drug
Glutathione
Glutathione analong
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple myeloma. The study will be conducted in two stages with 5-6 patients in each indication in Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.


Eligibility criteria: Inclusion Criteria:

* relapsed or refractory disease
* histologically or cytologically confirmed disease
* characteristic immunophenotypic profiles
* measurable disease (for lymphoma patients)
* ECOG performance status of 0-2
* adequate liver and kidney function
* adequate bone marrow reserves
* ineligible or unwilling to undergo autologous stem cell transplantation

Exclusion Criteria:

* failure to recover from any major surgery within 4 weeks of study entry
* pregnant or lactating women
* women of child-bearing potential not using reliable and appropriate contraception
* routine prophylactic use of G-CSF required within 2 weeks of study entry
* Grade 3 or higher peripheral neuropathy
* history of hepatitis B virus or HIV
* central nervous system or meningeal involvement by lymphoma or multiple myeloma

Primary outcomes:
measure: Objective Response Rate
timeFrame: At 6 weeks of treatment
measure: Objective Response Rate
timeFrame: At 12 weeks of treatment
measure: Objective Response Rate
timeFrame: At 18 weeks of treatment
measure: Objective Response Rate
timeFrame: At 24 weeks of treatment
Secondary outcomes:
measure: Duration of Response
timeFrame: At 6, 12, 18 & 24 weeks of treatment
measure: Safety Assessments
timeFrame: At 3, 6, 9, & 12 weeks of treatment
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Joseph Bertino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05396508: Interfacial Injection in Low Back Pain
Official title: The Effectiveness of Interfacial Injection Applied in Addition to Physical Therapy Applications in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-31
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Its effect on thoracolumbar fascia and low back pain has been investigated in different studies.These studies suggest that the anatomical and histological features of the fascia may have an effect on low back pain. This study aimed to investigate the effectiveness of interfacial injection in patients with chronic back pain.


Eligibility criteria: Inclusion Criteria:

* Low back pain for more than 6 months;
* Presence of MR findings radiologically diagnosing LDH;
* Numeric rating scale (NRS) \> 5

Exclusion Criteria:

* Spinal stenosis;
* Spondylolisthesis;
* Previous lumbar
* Spinal surgery

Primary outcomes:
measure: NRS
timeFrame: 6 month
Secondary outcomes:
measure: ODI
timeFrame: 6 month
measure: NSAİD
timeFrame: 6 month
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Bursa Yuksek Ihtisas Training and Research Hospital
name: Korgün Ökmen, Assoc. PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT03217708: Post Discharge Circadian Rhythms Post Adenotonsillectomy
Official title: Post Discharge Circadian Dysrhythmias, Sleep Disturbances, and Return to Baseline Activity in Children With Pre-existing Obstructive Sleep Apnea After AT (Adenotonsillectomy).
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Circadian Dysrhythmia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We are testing variability in circadian biomarkers

Brief summary: The purpose of this study is to utilize non-invasive, easily measurable biomarkers (heart rate, skin temperature, sleep, and activity) in the post surgical discharge period to identify trends which correlate with improved outcome and early recovery (return to baseline activity). These are measured (captured) utilizing a wearable technology (WT) device.

Return to baseline (RTB) activity for the purpose of this study is defined primarily as step count normalization as a surrogate of activity (pre versus post operative step count), and heart rate variability normalization back to preoperative baseline. Increased heart rate variability has been studied in acute care settings as a marker of poor prognosis. Please note that return to baseline is not defined for the pediatric population in the same way as adults (which is primarily questionnaire based and not applicable in children).

Detailed description: Wearable technology has tremendous advantages over current methods of assessing RTB activity in the post-discharge pediatric population after AT, which rely on quality of life (QOL) scales, caregiver and patient reports, as well as nurse phone calls and office visits. These methods are biased, time and labor intensive, disease focused, and caregiver dependent. The investigators propose to use wearable technology in order to assess RTB activity. The device has validated methodology in sleep metrics (as compared to polysomnography), heart rate and activity monitoring (optical sensor and 3 plane accelerometry), and temperature measuring (galvanic skin resistance). So far, no investigators have utilized wearable technology and biomarker (heart rate, skin temperature, activity, sleep) data in the manner proposed. RTB is a difficult to measure entity in children and the investigators have defined it using step count as a marker of activity. There are no studies or "standard" to measure quality of recovery in children.

Eligibility criteria: Inclusion Criteria:

* As stated previously, OSA v. non OSA

Exclusion Criteria:

-

Primary outcomes:
measure: Change in circadian rhythm
timeFrame: 3 week
measure: Change in circadian rhythm
timeFrame: 3 weeks
measure: Change in activity
timeFrame: 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
Study officials:
References:
Clinical trial NCT01085708: A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)
Official title: A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Rabeprazole
Japan
healthy Japanese male
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-12
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.


Eligibility criteria: Inclusion criteria:

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19

Exclusion criteria:

Subjects with allergy

Primary outcomes:
measure: The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research Center, Eisai, Co., Ltd
name: Kai Shibata
role: STUDY_DIRECTOR
References:
Clinical trial NCT06081608: Acute Kidney Injury Among Pediatric Cancer Patients At South Egypt Cancer Institute
Official title: Acute Kidney Injury Among Pediatric Cancer Patients At South Egypt Cancer Institute
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: To Determine the Cumulative Incidence of AKI Using KDIGO Criteria in Pediatric Patients With Malignancy in South Egypt Cancer Institute (SECI)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: •Children of both sexes (aged from 1 month to 18 years at diagnosis)

Brief summary: Cancer is the second most frequent cause of premature death in children. The incidence of pediatric cancer varies by region and country, but it is generally considered rare with an estimated 300,000 new cases diagnosed worldwide. Acute kidney injury in pediatric cancer patients refers to the sudden and often temporary loss of renal function, which can lead to a variety of complications if not treated correctly.

Detailed description: * Primary: To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI)
* Secondary:

  1. Incidence of Hospital-acquired and community-acquired AKI
  2. Asses the risk factors of the incidence of AKI
  3. To determine in-hospital outcome (time to in-hospital death, length of hospital stay, and time to kidney recovery) of AKI.

This is a prospective study that will be carried out in the Paediatric Oncology and Haematological Malignancies Department including patients diagnosed with malignant tumours and hospitalized from 1st April 2023 for one year duration.

Eligibility criteria: Inclusion Criteria:

* • Children of both sexes (aged from 1 month to 18 years at diagnosis)

  * Patients with either hematological malignancies or solid tumors admitted to the Paediatric Oncology and Haematological Malignancies Department

Exclusion Criteria:

* Children who had an unconfirmed cancer diagnosis.
* Children more than 18 years at diagnosis.
* Children with preexisting chronic kidney disease (CKD) that defined as the presence of structural or functional kidney damage that persist over minimum of three month
* The patient underwent hematopoietic stem cell transplantation. Patients with 1 s.Cr level.
* Patient underwent renal transplant.

Primary outcomes:
measure: To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI)
timeFrame: from November 2023 till November 2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03551808: Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients
Official title: Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cystoid Macular Edema After Phacoemulsification
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is determining the prophylactic effect of ketorolac tromethamine drop 0.5% eye drop on the functional and anatomical ocular characteristics of the diabetic patients after the phacoemulsification surgery. Cystoid macular edema (CME) is a ocular disease which the retinal thickness is increased by 30 % incidence at least or the visual acuity is decreased to 20/40 according to clinical definition. Ketorolac tromethamine is an non steroidal anti inflammatory medication which is used for treatment and Prophylactic for CME. Teh aim of this study is prophylactic effect of ketorolac tromethamine on choroidal and retinal thickness after Phacoemulsification in Diabetic Patients. In this randomized clinical trial, 102 eyes of 102 diabetic patients were included. All patients were undergone phacoemulsification surgery at Torfeh Eye Hospital between September 2015 and January 2017. To evaluate the prophylactic effect of ketorolac tromethamine topical eye drop, all cases were asked to apply it one day before the s:surgery in each 8 hours and continue it for 4 weeks after the surgery. Controls were not received placebo. All study population were examined using Snellen visual acuity chart, enhanced depth imaging optical coherence tomography (EDI-OCT). All patients were followed at 6, 12 and 24 weeks after the cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients (type II) with cataract
* Eligible patients at age range of 20 to 95 years old

Exclusion Criteria:

* Cases with a diabetic macular edema
* proliferative diabetic retinopathy
* history of intravitreal injection of bevacizumab and macular photocoagulation prior three months to the cataract surgery
* glaucoma
* refractive errors of more than ±6 diopters
* history of previous ocular surgery
* ocular pathological disorders
* history of systemic diseases
* history of medications which have a side effect on the retinal thickness
* patients with a follow up of less than 6 months
* individuals with any intraoperative complications will be excluded from this study.

Primary outcomes:
measure: Best Corrected visual acuity
timeFrame: 24 weeks after the surgery
Secondary outcomes:
measure: retinal and choroidal thickness
timeFrame: 24 weeks after the surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
Study officials:
References:
Clinical trial NCT04277208: Opioid-Free Study in Arthroscopic Rotator Cuff Repair
Official title: Opioid Free Arthroscopic Rotator Cuff Repair: A Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tears
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing ARCR will be asked to participate in this survey study

Brief summary: The purpose of this study is to develop and test an opioid-free pain control protocol for patients undergoing arthroscopic rotator cuff repair.


Eligibility criteria: Inclusion Criteria:

* All patients over the age of 18
* clinically indicated for an Arthroscopic Rotator Cuff Repair (ARCR)

Exclusion Criteria:

* Patients with irreparable rotator cuff tears
* allergic or sensitivity to the study medication
* intolerance to pain protocol
* history of gastrointestinal issues
* renal disease
* any evidence of glenohumeral arthritis

Primary outcomes:
measure: Time to fulfill oxycodone prescription
timeFrame: within first 3 days of surgery
Secondary outcomes:
measure: VAS pain (Visual Analog Scale)
timeFrame: Post-operative day 3
measure: Patient satisfaction
timeFrame: Post-operative day 3
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05293808: Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin
Official title: Evaluation of Different Doses of Aspirin on Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Diabetes Mellitus
Keywords: platelet aggregation
acute coronary syndrome
diabetes
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes is an important risk factor of coronary atherosclerosis, and it's well known that platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic therapy. Moreover, in diabetic patients platelets are characterized by high turnover that is responsible of lack of protection by cardioaspirin at common dosage. The aim of our study is to asses the efficacy of different doses of aspirin in diabetic patients with acute coronary syndrome.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with acute coronary syndrome after 24 hours from the coronarography

Exclusion Criteria:

* patients with a family or personal history of bleeding or thrombophilic disorders;
* platelet count \>600000/mmc or \<150000/mmc
* hematocrit \>50% or \<25%
* creatinine clearance \<30 mL/min

Primary outcomes:
measure: Effects of different doses of aspirin on platelet aggregation
timeFrame: 1 month
Secondary outcomes:
measure: Valuation of RAC1 levels in platelets
timeFrame: 1 month
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
Study officials:
References:
Clinical trial NCT02888808: Relationship of Obesity With GERD Among Nigerians
Official title: Relationship Between Body Mass Index, Waist Circumference, Waist Hip Ratio and Erosive Gastroesophageal Reflux Disease in a Tertiary Centre in Nigeria: a Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro-esophageal Reflux Disease With Ulceration.
Keywords: gastroesophageal reflux disease
women
Nigeria
obesity
Lead sponsor: Obafemi Awolowo University Teaching Hospital
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nigerians with dyspeptic symptoms

Brief summary: Obesity is a strong risk factor for GERD. This study assessed the role of obesity among patients having erosive GERD and controls.

Detailed description: A case control study of patients with erosive GERD. Patients with erosive GERD who had upper gastro-intestinal endoscopy were graded using the Los Angeles classification. Patients and controls had measurements of body mass index (BMI), WC (waist circumference), Waist hip ratio (WHR), and hip circumference (HC). Bio-data was collected from both groups and data were analysed using descriptive and inferential statistics. A p value of equal to or less than 0.05 was considered significant.

Eligibility criteria: Inclusion Criteria:

* Patients with dyspepsia

Exclusion Criteria:

* Patients that refused consent.
* Patients with gastric cancer
* Patients with gastric outlet obstruction
* Pregnant women
* Active gastrointestinal bleeding
* Cigarette smokers
* Patients on Naso-gastric tube.

Primary outcomes:
measure: Obesity associated with GERD
timeFrame: Immediate.
Secondary outcomes:
measure: Body mass index is associated with GERD
timeFrame: Immediate
measure: Waist circumference is associated with GERD
timeFrame: Immediate
measure: Waist hip ratio is associated with GERD
timeFrame: Immediate
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00395408: Linear Growth Study (0476-097)(COMPLETED)
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-11-02
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.


Eligibility criteria: Inclusion Criteria :

* Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty)
* Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty
* With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists)

Exclusion Criteria :

* Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1

Primary outcomes:
measure: To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups
Secondary outcomes:
measure: To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
measure: Beta-agonist use
measure: Oral corticosteroid rescues for asthma
measure: Discontinuations due to asthma
measure: Peripheral blood eosinophil count
measure: Markers of bone turn-over
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Becker AB, Kuznetsova O, Vermeulen J, Soto-Quiros ME, Young B, Reiss TF, Dass SB, Knorr BA; Pediatric Montelukast Linear Growth Study Group. Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study. Ann Allergy Asthma Immunol. 2006 Jun;96(6):800-7. doi: 10.1016/s1081-1206(10)61342-7.