louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00073515: Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices
Official title: A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Catheters, Indwelling
Keywords: central venous access device
thrombosis
central venous catheter
thrombolysis
fibrinolysis
Lead sponsor: ARCA Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2003-11-25
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood). The trial compares a new blood clot dissolving agent (alfimeprase) against the currently used treatment.


Eligibility criteria: Subjects must:

* have a dysfunctional Central Venous Access Device (CVAD) defined as unable to withdraw 3 mL blood
* have had the device in place for \> 48 hours
* be clinically stable
* be 18 or older
* give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
Clinical trial NCT04605315: Indications and Outcomes in Kidney-ureteral Pediatric Lithiasis: Experience of Parma
Official title: Indications and Outcomes in Kidney-ureteral Pediatric Lithiasis: Experience of Parma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Stone, Urinary
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 70
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 0-17 yrs old, urinary stones (kidney, ureteral, not bladder), with or without malformations or metabolic diseases

Brief summary: Incidence of paediatric urolithiasis is increasing in Europe and North America. Nowadays the management of stone disease is a common practice in not endemic country. The surgical's treatment is based on similar techniques as for adults. In the last years due to miniaturization of endoscopic instruments endourology has become the best approach to treat urinary stones in children. The investigators have retrospectively reviewed experience from 01/01/2000 to 28/02/2019 in children ≤ 16 years old affected by urinary stones who underwent rigid and flexible ureterorenoscopy and pecutaneous nephrolitotripsy procedures and recorded clinical data, overall success rate and complication.


Eligibility criteria: Inclusion Criteria:

* 0-17 yrs old, urinary stones (kidney, ureteral, not bladder), with or without malformations or metabolic diseases

Exclusion Criteria:

* none

Primary outcomes:
measure: stone free rate
timeFrame: immediately
measure: stone free rate
timeFrame: 3 months follow up
measure: complication rate
timeFrame: immediately
measure: complication rate
timeFrame: 3 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Parma
country: Italy
facility: AOU Parma
Study officials:
References:
Clinical trial NCT04745715: Genomic Study in Non-small Cell Lung Cancer Brain Metastasis
Official title: Genomic Analysis in Surgically Treated NSCLC Brain Metastasis Based on Neurosurgical Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC Stage IV
Brain Metastases
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with non-small cell lung cancer underwent craniectomy, who completed postoperative whole brain radiotherapy and associated chemo or target therapy

Brief summary: The investigators collected the data from the investigators' center between January 2011 and October 2020. The study included all non-small cell lung cancer patients with surgically excised brain metastasis. The investigators analysis the correlation of gene mutation and the disease course.

Detailed description: The investigators collected the data from from the investigators' center between January 2011 and October 2020. The study included all non-small cell lung cancer patients with surgically excised brain metastasis. The investigators analysis the correlation of gene mutation and the disease course. The investigators use Kaplan-Meier regression to analyze the overall survival, and the difference between the groups was calculated using log rank test. Cox proportional hazards method was used to create the regression model and estimate the hazard ratios.

Eligibility criteria: Inclusion Criteria:

- patients diagnosed with non-small cell lung cancer who underwent craniectomy and subsequent whole brain radiotherapy and associated chemo or target therapy

Exclusion Criteria:

* patient who did not receive postoperative adjuvant therapy

Primary outcomes:
measure: postoperative survival
timeFrame: From date of craniectomy until the date of patient deceased or date of last followed medical record, with median follow up around to 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University hospital
Study officials:
References:
Clinical trial NCT04888715: To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers
Official title: An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between "DWN12088" and "Pirfenidone" or "Nintedanib" in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-05-17
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers

Detailed description: This clinical trial is an open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 55 years at screening
* Subjects who voluntarily decided to participate in the study and provided written consent to after receiving a detailed explanation on this study and fully understanding the information

Exclusion Criteria:

* Subjects who received another investigational agent in another study (including bioequivalence study) within 180 days prior to the first dose of the IP (The end of prior study participation will be the date of the last dose, and the days will be counted from the next day \[1 day\].)
* Female subjects who are pregnant or lactating

Primary outcomes:
measure: Cmax of Pirfenidone and DWN12088
timeFrame: 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour
measure: AUC of Pirfenidone and DWN12088
timeFrame: 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour
measure: Cmax of Nintedanib and DWN12088
timeFrame: 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour
measure: AUC of Nintedanib and DWN12088
timeFrame: 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Cha Unitersity Bundang Medical Center
Study officials:
affiliation: CHA UNITERSITY BUNDANG MEDICAL CENTER
name: Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01356615: Low Molecular Weight Heparin for Hemodialysis Anticoagulation
Official title: Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Keywords: anticoagulation
hemodialysis
heparin
lipids
low molecular weight heparins
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 27
Sex: ALL
Minimum age (years): 25
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as anticoagulation during hemodialysis (HD) therapy. In this study the investigators have compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.

Detailed description: In this prospective, randomized, cross-over study the investigators compared the safety, clinical efficacy of Clexane (enoxaparin sodium; Sanofi-Aventis) with unfractionated heparin in 27 chronic HD patients. Group A received Clexane (enoxaparin sodium; Sanofi-Aventis) and were followed up for 3 months and then crossed over to Unfractionated heparin for a further 3-month period. Group B received Unfractionated heparin first and then crossed over to Clexane, each followed up for 3 months. Heparin anticoagulation, clinical clotting and hemorrhage were evaluated by visual inspection after blood draining of the air trap.

Eligibility criteria: Inclusion Criteria:

* patients in end stage renal failure requiring maintenance dialysis were recruited into the study

Exclusion Criteria:

* Patients with known bleeding disorders
* Subjects receiving oral or other forms of anticoagulant therapy (e.g. warfarin, aspirin) or drugs that could affect heparin activity (e.g. digitalis, tetracyclines, and antihistamines) were also excluded. Subjects continued their usual medication (including lipid-lowering therapy ) and were treated in the normal manner by their caring physicians during the study.

Primary outcomes:
measure: Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection
timeFrame: 3 month
Secondary outcomes:
measure: changes in serum Cholesterol,low and High Density Lipoprotein and Triglycerid.
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01562015: A Study of Ganetespib in Subjects With ALK-Positive Non-Small-Cell Lung Cancer (NSCLC)
Official title: A Single Arm, Phase 2 Study of Ganetespib in Subjects With Advanced Non-Small-Cell Lung Cancer With Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior therapies. The study will take place globally at multiple study centers. Subjects will be enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and will repeat this schedule until the cancer gets worse or the subject is unable to tolerate ganetespib. The primary goal of the study is to determine how ganetespib is tolerated and how active it is in ALK positive NSCLC.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 years or older
* Pathological confirmation of advanced NSCLC
* Evidence of a translocation or an inversion event involving the ALK gene locus
* ECOG Performance Status 0 or 1

Exclusion Criteria:

* Prior therapy with ALK-targeted agents
* Prior treatment with Hsp90 inhibitor
* Known EGFR activating mutation
* Presence of active or untreated central nervous system (CNS) metastases

Primary outcomes:
measure: Objective response rate
timeFrame: 1 year
Secondary outcomes:
measure: Duration of Response
timeFrame: 1 year
measure: Disease Control Rate
timeFrame: 6 weeks and 12 weeks
measure: Adverse events
timeFrame: 1 year
measure: Progression Free Survival
timeFrame: From the date of study drug start until the date of first documented progression or date of death from any cause, whichever comes frist, assessed up to 3 years
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Florida
city: Cleveland
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Ohio
city: Hamilton
country: Canada
facility: Synta Pharmaceuticals Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Synta Pharmaceuticals Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Synta Pharmaceuticals Investigative Site
state: Ontario
Study officials:
References:
Clinical trial NCT04845815: Renal Tubular Disorders in Egyptian Children
Official title: Patterns of Renal Tubular Disorders in Egyptian Children: a Single Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Tubular Disorders in Children
Keywords: renal tubular disorders
failure to thrive
metabolic acidosis
metabolic alkalosis
hypokalemia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 58
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: all children who have renal tubular disorders (inpatient and outpatient) in the Paediatric Department, Sohage University Hospital.

Brief summary: Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children.

Detailed description: Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children. As a result, starting management early will help those children have a better life. Therefore awareness about these disorders and long-term outcome is really important. The investigators present the clinical characterizations of many tubular disorder and the follow up in our center.

The aim of this study is to reveal the different clinical presentations and the main lab features of renal tubular disorders in children to promote early recognition and management.

Eligibility criteria: Inclusion Criteria:

* All children aged from one month to 18 years who have renal tubular disorders.

Exclusion Criteria:

* Children who have renal tubular disorders secondary to drugs, intoxication, obstructive uropathy or transient in nature.

Primary outcomes:
measure: weight
timeFrame: 1 years
measure: Glomerular function
timeFrame: 1 years
measure: height
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: pediatric department, Sohag university hospital
Study officials:
References:
Clinical trial NCT03102515: Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section
Official title: Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section: a Randomized Trial. (TAP-CAT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Analgesia following surgery associates different intra-venous or oral analgesic drugs and sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be administered as a complement. In the specific context of caesarean sections, pain control is mandatory to enable the mother to take care of her offspring and shorten their hospital stay. This intervention is mainly performed under neuraxial anaesthesia (spinal or epidural), enabling the injection of morphine in the subdural or epidural space, as part of a multimodal analgesia regimen.

Studies have evaluated continuous wound infiltration catheters (CIC) and ultrasound-guided (UGD) transabdominis plane (TAP) block, and both techniques and both techniques reduce postoperative morphine consumption. Recent studies have compared the two techniques and found conflicting results. Furthermore, they did not consider caesarean section performed under epidural analgesia, with a different neuraxial injection site, neither did they compared pain after postoperative day 2.

Consequently, the aim of this study was to compare resting and standing pain up to postoperative day 3 after caesarean section performed under spinal or epidural anaesthesia and receiving either USG-TAP block or CIC. Baseline hypothesis was that the continuous infiltration provided a better analgesia at day 2.


Eligibility criteria: Inclusion Criteria:

* Informed consent,
* Age\>/=18 years,
* Caesarean section under spinal or epidural anaesthesia
* Technique surgical "Cohen Stark méthod".

Exclusion Criteria:

* Patient refusal,
* Patient under guardianship,
* Contraindication to one of the two techniques,
* Cesarean section under general anesthesia
* Allergies to local anesthetics
* Maternal instability

Primary outcomes:
measure: Postoperative standing pain at day 2
timeFrame: Evaluate standing pain at 48 hours postoperatively
Secondary outcomes:
measure: standing and resting pain measured during the first 3 days
timeFrame: Evaluate pain at during 3 days postoperatively
measure: Cumulative dose of Tramadol during the first 3 days
timeFrame: during the first 3 days
measure: Cumulative dose of nefopam during the first 3 days
timeFrame: during the first 3 days
measure: Cumulative dose of oxycodone during the first 3 days
timeFrame: during the first 3 days
measure: patient comfort assessed daily by visual analogic scale
timeFrame: during the first 3 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02904915: Paracervical Block Versus No Paracervical Block During IUD Insertion
Official title: Paracervical Block Versus No Paracervical Block During IUD Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
IUD Insertion
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.


Eligibility criteria: Inclusion Criteria:

* Women of reproductive age who present for an IUD insertion procedure at the University of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

Exclusion Criteria:

* Women with current pelvic inflammatory disease (PID)
* Women who are not good candidates for an IUD
* Patients who have a Lidocaine allergy

Primary outcomes:
measure: Pain Score as Assessed by a Visual Analogue Scale (VAS)
timeFrame: baseline (about 30 seconds after insertion of the speculum)
measure: Pain Score as Assessed by a Visual Analogue Scale
timeFrame: about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum)
measure: Pain Score as Assessed by a Visual Analogue Scale
timeFrame: about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Pamela D Berens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06798415: Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis
Official title: The Clinical Effect of Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis: Single-arm Open-label Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cutaneous Leishmaniasis
Lead sponsor: Al-Mustafa University College
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study to evaluate the effectiveness of intralesional metronidazole 0.5% solution as a local injection in treating cutaneous leishmaniasis.

In an open-label single-arm clinical trial, all patients will be given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion will be considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.

Intralesional metronidazole (5 mg/ml, 100 ml, Flagyl®, Sanofi, France) will be injected into each lesion based on its size (5 mg/cm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment, and patients will be only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion.


Eligibility criteria: Inclusion Criteria:

* Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis

Exclusion Criteria:

* Immunocompromised
* Allergic reaction to treatment.

Primary outcomes:
measure: Cure rate
timeFrame: From enrollment to the end of treatment up to 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Mustansiriyah University
Study officials:
References: