louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03034096: General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial
Official title: General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, General
Surgical Oncology
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 1826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.


Eligibility criteria: Inclusion Criteria:

* Patients with known or suspected cancer and scheduled to undergo any of the following oncologic surgical procedures:

  * Lobectomy or pneumonectomy
  * Esophagectomy
  * Radical (total) cystectomy
  * Pancreatectomy
  * Partial hepatectomy
  * Hyperthermic intraperitoneal chemotherapy (HIPEC)
  * Gastrectomy (subtotal or total)
  * Cholecystectomy or bile duct resection

Exclusion Criteria:

* Age less than 18 years
* American Society of Anesthesiologist Class 5
* Projected life expectancy less than 30 days
* Known or suspected hypersensitivity to either propofol, e.g. egg or soy allergy, or volatile general anesthetic agents
* Known or suspected history of malignant hyperthermia

Primary outcomes:
measure: All-cause mortality
timeFrame: 2 year minimum
Secondary outcomes:
measure: Recurrence free survival
timeFrame: Minimum 2 years
measure: All-cause mortality as a binary outcome
timeFrame: 2 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Center
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
References:
Clinical trial NCT00348296: Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
Official title: A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scleroderma, Systemic
Keywords: Scleroderma, Systemic
Lead sponsor: Benesis Corporation
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to assess the safety of GB-0998.


Eligibility criteria: Inclusion Criteria:

* Patients who have sclerosis located proximal to the elbow joint with diffused systemic scleroderma.
* Patients who have not less than 20 points of TSS.
* Patients with no appropriate therapeutic treatment.

Exclusion Criteria:

* Patients with severe hepatic disorder, severe renal disorder or severe heart disorder.
* Patients with malignant tumors.
* Patients who have the anamnesis of shock or hypersensitivity to this drug.
* Patients who have the anamnesis of cerebral infarction or symptom of these diseases.
* Patients who have been diagnosed as IgA deficiency in their past history.
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant.
* Patients who had any dose increase or new dosing of steroid within 12 weeks before consent.
* Patients who were administered other investigational drug within 12 weeks before consent.

Primary outcomes:
measure: Changes in TSS at 12 weeks
Secondary outcomes:
measure: Changes in joint motion, oral aperture, active hand spread, fingertip-to-palm distance, health assessment questionnaire, histological analysis of dermal section at 12 weeks.; Adverse events and laboratory test.
Other outcomes:
Locations:
city: Nagasaki
country: Japan
facility: Nagasaki University
Study officials:
affiliation: Kanazawa University
name: Kazuhiko Takehara, Professor
role: STUDY_CHAIR
References:
citation: Takehara K, Ihn H, Sato S. A randomized, double-blind, placebo-controlled trial: intravenous immunoglobulin treatment in patients with diffuse cutaneous systemic sclerosis. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):151-6. Epub 2013 Jul 23.
Clinical trial NCT01719796: Effect of TAP Block on Ventilatory Function Following Abdominal Surgery
Official title: Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Laparotomy
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 60
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: Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* laparotomy

Exclusion Criteria:

* below 18, pregnancy, prisoners

Primary outcomes:
measure: vital capacity
timeFrame: 72h
Secondary outcomes:
measure: maximum forced expiratory flow
timeFrame: 72h
measure: analgesic consumption
timeFrame: 72h
measure: pain
timeFrame: 72h
measure: diaphragmatic course
timeFrame: 72h
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Saint-Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
Study officials:
affiliation: Pierre et Marie Curie University, Paris, France
name: Mathieu RAUX, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00993096: Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
Official title: A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.

The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area (AUC) under the glucose infusion rate curve
timeFrame: From 0 to 24 hours after single-dose administration
Secondary outcomes:
measure: Area (AUC) under the insulin aspart concentration time curve
timeFrame: From 0 to 24 hours after single-dose administration
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Nosek L, Klein O, Coester H, Svendsen AL, Haahr H. Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):659-64. doi: 10.1111/dom.12463. Epub 2015 May 1.
Clinical trial NCT02382796: A Rollover Protocol of Dacomitinib For Patients In Japan
Official title: TREATMENT ACCESS PROTOCOL FOR PATIENTS PREVIOUSLY TREATED WITH DACOMITINIB ON A CLINICAL TRIAL IN JAPAN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-03-09
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study to permit continued access to dacomitinib for patients who participated in other dacomitinib monotherapy treatment protocols in Japan and have the potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib treatment.

Detailed description: The intention of the study is to allow continued use of dacomitinib in Japan for patients on closed dacomitinib clinical trials and who continue to experience clinical benefit.

Eligibility criteria: Inclusion Criteria:

* Patients who received dacomitinib on another clinical trial in Japan
* Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

* Patients who meet one or more study withdrawal criteria on the prior study
* Participation in other studies involving other investigational drug(s) during study participation

Primary outcomes:
measure: Number of Participants Who Were Previously Treated With Dacomitinib on the Parent Study in Japan and Who Got Access to Dacomitinib in This Extension Study
timeFrame: 4 years
Secondary outcomes:
measure: Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
Other outcomes:
Locations:
city: Kanazawa City
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Osaka-city
country: Japan
facility: Osaka City General Hospital Department of Clinical Oncology
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suntougun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital,Japanese Foundation for Cancer Research
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01542658: Comparison of Robot-assisted Laparoscopic Myomectomy With Traditional Laparoscopic Myomectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Myoma
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with uterine myoma, and underwent primary treatment (RALM and TLM) in Far Eastern Memorial Hospital

Brief summary: This study is to reveal any potential advantage of Robot-assisted Laparoscopic Myomectomy (RLAM) over Traditional Laparoscopic Myomectomy (TLM) by comparing the perioperative variables and short-term outcome of RALM and TLM patients.

Detailed description: All patients with symptomatic uterine myomas who underwent traditional laparoscopic myomectomy or robotic laparoscopic myomectomy were enrolled.

Eligibility criteria: Inclusion Criteria:

* cases with uterine myoma

Primary outcomes:
measure: amount of postoperation abdominal drainage
timeFrame: 5 days
Secondary outcomes:
measure: operation time
timeFrame: 1 day
measure: blood loss
timeFrame: 1 day
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT03950258: Endovascular Management of Pediatric Intracranial Arteriovenous Shunts
Official title: Endovascular Management of Pediatric Intracranial Arteriovenous Shunts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Malformations
Arteriovenous Fistula
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * Review the outcomes of the Endovascular management of pediatric intracranial arteriovenous shunts.
* Give an effective treatment for pediatric intracranial arteriovenous shunts and can detect the best method could be used and assess safety and efficacy of different endovascular techniques in treatment of different AV shunts.
* Improve the outcome of these patients and decease rate of recurrence and complications.

Detailed description: Intracranial arteriovenous shunts (ICAVS) in young children are characterized by frequent high-flow fistulas. In association with high-flow fistulas and the physiological condition of the developing brain and heart, each ICAVS type tends to present at a certain age with unique symptoms.

Vein of Galen aneurysmal malformation (VGAM) and dural sinus malformation with arteriovenous (AV) shunt tend to present in the neonate with high output cardiac failure. In infancy, VGAM, pial arteriovenous fistula (AVF) and infantile dural AVF (DAVF) tend to present with hydrodynamic disorder such as macrocephaly, ventriculomegaly, prominent facial veins, and developmental delay.

Pial AVF, AV malformation, and infantile DAVF can present with focal neurological signs such as seizure or hemorrhage at older ages they are in the subpial space, as opposed to VGAM or DAVF, which are extrapial in location and tend to present with systemic symptoms .

Endovascular treatment is currently the first choice of treatment for most pediatric ICAVS. The treatment goal should be defined on a patient-by-patient basis, according to the unique physiological condition of the child.

Eligibility criteria: Inclusion Criteria:

* 1- clinical manifestation of AV shunt according to the pathology with radiological diagnosis by CT angiography or MRA 2- patient must be under 18 years old

Exclusion Criteria:

1. Any patient above 18 years old
2. Asymptomatic patients

Primary outcomes:
measure: Independent clinical outcome changes
timeFrame: within one week after treatment
Secondary outcomes:
measure: Radiological outcome:
timeFrame: Immediate post treatment and at 6 and 12 months post treatment
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Assiut University
name: Osama Ramadan, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01627158: Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte
Official title: Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Males and females, 18-60 (inclusive) years of age.

Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
5. Pregnant or lactating females.

Primary outcomes:
measure: Pharmacokinetic parameter Cmax of plasma budesonide concentration
timeFrame: within 12 h
measure: Pharmacokinetic parameter AUCt of plasma budesonide concentration
timeFrame: 12 h
measure: Pharmacokinetic parameter Cmax of plasma formoterol concentration
timeFrame: 24 h
measure: Pharmacokinetic parameter AUCt of plasma formoterol concentration
timeFrame: 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: PAREXEL International GmbH
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Irja Korpela, MSc
role: STUDY_DIRECTOR
affiliation: Parexel Berlin
name: Rainard Fuhr, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05490758: Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP
Official title: Comparison of Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: sensorimotor training
motor function
constraint induced movement therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the work was to find out the effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy.

Detailed description: The significance of this study is that there was paucity of literature in finding the comparative effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy. The aim is to find out the effects of sensorimotor training on motor functioning of the upper extremity in comparison of constraint induced movement therapy.

Eligibility criteria: Inclusion Criteria:

* subjects who were fully oriented
* children diagnosed with hemiplegic cerebral palsy
* no history of intramuscular botulinum injections past one year

Exclusion Criteria:

* children with epilepsy
* gross deformity of upper limb
* children with contractures

Primary outcomes:
measure: nine hole peg test
timeFrame: 4 weeks
Secondary outcomes:
measure: manual ability classification system
timeFrame: 4 weeks
Other outcomes:
measure: two point discrimination
timeFrame: 4 weeks
Locations:
city: Lahore
country: Pakistan
facility: Rising Sun Institute
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajiha Shahid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3.
citation: Santana CAS, Tudella E, Rocha NACF, de Campos AC. Lower Limb Sensorimotor Training (LoSenseT) for Children and Adolescents with Cerebral Palsy: A Brief Report of a Feasibility Randomized Protocol. Dev Neurorehabil. 2021 May;24(4):276-286. doi: 10.1080/17518423.2020.1858458. Epub 2021 Jan 3.
citation: Samaei A, Mirshoja MS, Khalili MA. Comparison of Sensorimotor Retraining Methods by Movement Therapy Based on Limitations in Upper Extremity Function in Patients with Chronic Stroke. INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND ALLIED SCIENCES. 2016;5(2):510-+.
Clinical trial NCT01541358: Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
Official title: Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bone Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnostic procedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bone cancer

Detailed description: The objective of the study is to use 18F sodium fluoride (fluorine F-18 sodium fluoride) PET/CT scanning to detect and characterize lesions in patients who have suspected skeletal malignancy. We hypothesize that scanning with 18F-NaF (fluorine F-18 sodium fluoride) is more sensitive for skeletal abnormalities and may better characterize lesions than conventional imaging.

Eligibility criteria: Inclusion Criteria:

* Patients referred for evaluation of suspected skeletal cancer
* Patients must understand and voluntarily sign an informed consent form after the contents have been fully explained to them

Exclusion Criteria:

* Patients who cannot complete a PET/CT scan
* Pregnant women
* Healthy volunteers

Primary outcomes:
measure: Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy
timeFrame: an estimated average of 2 hours
Secondary outcomes:
measure: Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
timeFrame: an estimated average of 2 hours
measure: Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
timeFrame: an estimated average of 2 hours
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrew Quon
role: PRINCIPAL_INVESTIGATOR
References: