louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00150319: An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Following Multiple Dosing With Vfend
Official title: An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Iv Containing Sbecd As An Excipient Following Multiple Dosing With Vfend®; I.V. In Subjects With Moderately Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Kidney Failure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency

Detailed description: The study was put on hold after the first subject was enrolled and experienced a serious adverse event (SAE) of renal failure chronic after receiving his I.V. dose on Day 1. The study was taken off hold after the subject recovered and an independent consultant had deemed the SAE as not treatment related; however, the site was unwilling to enroll additional subjects. Another site, based in New Orleans, was damaged by hurricane Katrina and was unable to enroll any subjects. A decision was made by the sponsor to terminate the study on 11 Apr 2006 due to poor study enrollment. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility criteria: Inclusion Criteria:

* Patients with moderate renal insufficiency

Exclusion Criteria:

* Active infection

Primary outcomes:
measure: Ability to tolerate up to seven days of intravenous voriconazole without worsening of pre-existing renal insufficiency
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02132819: Withholding Feeds During Red Blood Cell Transfusion and TRAGI
Official title: The Effect of Withholding Feeds During Red Blood Cell Transfusion on Development of TRAGI in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Transfusion
Feeding During Transfusion
Transfusion Related Acute Gut Injury
Necrotising Enterocolitis
Keywords: transfusion
feeding
TRAGI
NEC
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 150
Sex: ALL
Minimum age (years): 7
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns. During the last years, investigators ran retrospective observational studies abut NEC developing within the 48 hours after red blood cell transfusion. In the previous studies, the incidence of transfusion associated NEC (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis about transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion, similar to transfusion related acute lung injury (TRALI) seen in adults.In most of the neonatology clinics, withholding feeds during transfusion is not preferred. But several recent studies show an increase in the incidence of TANEC if the newborn goes on feeding before, during and after the transfusion process, especially if it is fed with a formula. The main aim of this study is to investigate the effect of withholding feeds during transfusion, on the development of TRAGI.


Eligibility criteria: Inclusion Criteria:

* \<32 weeks of gestational age or \<1500 gr, \>7 days old premature babies.
* Babies which are fed enterally well at the time of tha planning of transfusion.

Exclusion Criteria:

* Babies with severe sepsis signs.
* Babies with severe hypoxia and asphyxia.
* Babies with congenital anomaly or complex cardiac anomaly.

Primary outcomes:
measure: increase in the abdominal circumference
timeFrame: within 3 days after transfusion but participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes:
measure: increase in the amounts of gastric residual aspirates
timeFrame: Within 3 days after the transfusion
Other outcomes:
measure: occult or obvious blood in stool
timeFrame: within 1 day after transfusion
Locations:
city: Ankara
country: Turkey
facility: Suzan Sahin
state: Altındag
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Suzan Sahin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04904419: Multi-center Research Project for Glioma Molecular Pathology Intraoperative Rapid Detection
Official title: Multi-center Research Project for Glioma Molecular Pathology Intraoperative Rapid Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma, Malignant
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Glioma patients with Informed Consent Form
2. Glioma patients with intact clinical information

Brief summary: We explores the accuracy and sensitivity of rapid intraoperative detection of IDH, TERT, BRAF indicators through a prospective clinical multi-center study. This part includes a total of 300 fresh tissue samples, paired blood samples, relevant clinical information and follow-up information from 300 patients with different grades of adult glioma. By comparing with the postoperative sequencing results, the specificity and sensitivity of intraoperative IDH and TERT rapid detection results are clear.


Eligibility criteria: Inclusion Criteria:

* 1. Glioma patients with Informed Consent Form 2. Glioma patients with intact clinical information

Exclusion Criteria:

* 1. Glioma patients without Informed Consent Form 2. Glioma patients without intact clinical information

Primary outcomes:
measure: Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
timeFrame: Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Shanghai
country: China
facility: Huashan Hospital(West campus)
city: Shanghai
country: China
facility: Huashan Hospital
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
Study officials:
References:
Clinical trial NCT00149019: Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.
Official title: Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Solid Tumors
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with resistant metastatic solid tumors failing all conventional modalities who are eligible for immunotherapy by bispecific antibodies.

First step: NST Second step: Patients with tumor cells expressing positive Her-2Neu and/or EpCAM with residual or recurrent disease following NST will be candidates for donor lymphocytes immunotherapy using bispecific antibodies.

Patients with no matched donor available, expressing positive Her-2Neu and/or EpCAM tumor cells, will be eligible for donor mismatched lymphocytes using in-vitro rIL-2 activated allogeneic lymphocytes targeted to the tumor by bispecific antibodies, Her-2Neu and/or EpCAM.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic solid tumors expressing Her-2/Neu or EpCAM, with available match donor for NST.
* Patients with metastatic solid tumors not expected to be cured failing available conventional modalities, age \>18, with no upper age limit.
* Patients with metastatic breast cancer failing treatment with Herceptin.
* Patients with metastatic cancer cells expressing Her-2/Neu or EpCAM.
* Patients with evidence of disease following allogeneic stem cell transplantation with tumor cells expressing Her-2/Neu or EpCAM.
* Karnofsky performance status \>60%
* Life expectancy \> 3 months, to be able to assess response.

Exclusion Criteria:

* Patients not fulfilling any of the above.
* Patients with active or ongoing infection that may endanger their life, whenever immunosuppression may be counter-indicated.
* Pregnant or lactating women.
* Patients positive for HIV.

Primary outcomes:
measure: The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
Secondary outcomes:
measure: To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shimon Slavin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06092619: Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders
Official title: Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Motor Disorders
Keywords: Vojta Therapy
Neuromotor disorders
Motor function
Children
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial has been designed that will assess gross motor function from the start of the rehabilitation intervention (with Vojta therapy or other methodologies).
Primary purpose: TREATMENT

Brief summary: Functionality and motor skills during activities of daily living have progressively gained importance as tools for classification, assessment and research of neuromotor disorders and the treatment methodology according to Dr. Vojta or Reflex Locomotion follows this criterion in the clinical field. Vojta therapy is a commonly extended tool in the field of pediatric rehabilitation. This methodology acts on the ontogenic postural function and automatic postural control, on which different environmental aspects will later act. It is not a functional training, to avoid the voluntary movement available according to the pathology by means of compensations. Vojta therapy would be the key to unlock the development of gross motor function, later used in the movement of daily life activities, including other therapies such as conventional physiotherapy, sensory stimulation, occupational therapy, etc. This study aims to demonstrate that there are changes in the motor development of children with cerebral palsy with the application of Vojta Therapy.


Eligibility criteria: Inclusion Criteria:

* Male and female children
* Diagnosis of cerebral palsy or neuromotor disease

Exclusion Criteria:

* healthy subjects
* Patients receiving other therapy during the procedure

Primary outcomes:
measure: Gross Motor Function Measure (GMFM).
timeFrame: Baseline and immediately after the intervention
measure: Infant Motor Profile (IMP) scale
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Date of birth
timeFrame: Baseline
measure: Diagnosis
timeFrame: Baseline
measure: Number of previous physiotherapeutic treatments
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00548119: NeoCart Phase 2 Clinical Trial
Official title: A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Articular Cartilage Damage
Lead sponsor: Histogenics Corporation
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with symptomatic knee pain indicative of an articular cartilage injury and able and willing to give informed consent.

Exclusion Criteria:

* Patients with any previous surgical treatment other than debridement or microfracture of the study cartilage defect.

Primary outcomes:
measure: The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy.
timeFrame: One year
Secondary outcomes:
measure: This study will extend the experience derived from our Phase 1 study.
timeFrame: One year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Bloomington
country: United States
facility: TRIA Orthopedic Center
state: Minnesota
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: West Point
country: United States
facility: Keller Army Community Hospital
state: New York
city: Durham
country: United States
facility: Duke Sports Medicine Center
state: North Carolina
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
References:
citation: Anderson DE, Williams RJ 3rd, DeBerardino TM, Taylor DC, Ma CB, Kane MS, Crawford DC. Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries. Am J Sports Med. 2017 Mar;45(4):875-883. doi: 10.1177/0363546516677255. Epub 2017 Jan 9.
Clinical trial NCT00831519: The Effect of Diabetes on the Newborn
Official title: Biochemical, Hematologic, and Inflammatory Effects of Diabetes on the Newborn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2009-01-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who plan to deliver at Western Galilee Hospital

Brief summary: The aim of this study is to test and compare biochemical, hematological, and inflammatory factors in diabetic and healthy pregnant mothers and in their newborns.


Eligibility criteria: Inclusion Criteria:

* pregnant women

Exclusion Criteria:

-

Primary outcomes:
measure: oxidative stress
timeFrame: Immediately after delivery by cesarean section
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital- Nahariya
Study officials:
References:
Clinical trial NCT03921619: Sling Use and Functional Mobility in a Geriatric Population
Official title: Impact of Sling Use on Functional Mobility in a Geriatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be asked to perform two balance assessments (Tinetti Balance Scale, Get Up and Go Test) while: 1) not wearing a sling; and 2) wearing a sling on the dominant arm. Additional data will be collected regarding patient frailty with the Edmonton Frail Scale, as well as data regarding sling use and falls in the form of a questionnaire.
Primary purpose: OTHER

Brief summary: Shoulder slings are commonly worn after shoulder surgery. In geriatric patients, painstaking care is taken to reduce any factors that may increase the chance of experiencing a fall. Currently, it is not understood if wearing a sling affects someone's general gait and balance.

Detailed description: Following many shoulder operations, patients are immobilized in an bulky sling with non-weight bearing restrictions for periods of up to 6 weeks. This is necessary to allow for soft tissue healing particularly following repair of rotator cuff tears and shoulder replacement surgeries, two common procedures performed in the elderly population. Previous studies have shown that natural arm swing plays an essential role in maintaining balance and normal gait patterns. Decreased functional mobility and gait impairment has been shown to increase the risk of falls, mortality, and morbidity in an elderly population. However, following upper extremity surgery requiring the use of a sling, targeted therapy for gait and balance training is rarely prescribed. Consequently, the investigators wish to assess whether or not sling use impacts functional mobility test scores in an elderly population. The aim of this project is to maximize perioperative functionality in these patients in efforts to prevent any unanticipated secondary injury.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 65 years of age

Exclusion Criteria:

* Younger than 65 years of age
* Pre-existing cognitive impairment
* Pre-existing mobility impairment
* Pre-existing symptomatic upper or lower extremity disease

Primary outcomes:
measure: Tinetti Test
timeFrame: 30 seconds
measure: Timed Up & Go Test
timeFrame: 30 seconds
measure: Edmonton Frail Scale
timeFrame: 1 minute
measure: Sling / Fall Questionnaire
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital Highlands
state: Alabama
Study officials:
References:
Clinical trial NCT05217719: Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients
Official title: Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients With Pneumonia With Thrombocytopenia: a Multicenter, Single-blind, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pneumonia
Thrombocytopenia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Southern Medical University
name: The Second People's Hospital of GuangDong Province
name: Shenzhen Hospital of Southern Medical University
First posted: 2022-02-01
Enrollment: 178
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: The incidence of thrombocytopenia in ICU patients with severe illness ranged from 8.3% to 67.6%, and ranged from 14% to 44% during ICU treatment.Severe patients with thrombocytopenia also have significantly increased bleeding events and blood transfusions, and even a significantly increased risk of death.This study examines whether elevated platelets benefit patients with pneumonia


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pneumonia (community acquired pneumonia, hospital acquired pneumonia or ventilator associated pneumonia);
* Voluntarily signed informed consent;
* ≥18 years old;
* Platelet count ≤75×109/L

Exclusion Criteria:

* A history of hematopoietic stem cell transplantation or solid organ transplantation such as liver, kidney or lung;
* Hematological malignancy;
* Immune thrombocytopenia, such as SLE, ITP, TTP, etc.
* The length of stay in ICU is less than 24h;
* Pregnant or lactation patients;

Primary outcomes:
measure: The time to recovery to a normal platelet level
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03542019: Survival of Endocrowns Made From Different Ceramics
Official title: The Endocrown; a Prospective Randomised Clinical Trial of Three Different Ceramics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulp Disease, Dental
Dental Caries
Dental Leakage
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three different ceramic types for restoration of endodontically treated teeth
Primary purpose: TREATMENT

Brief summary: Restoration of endodontically treated teeth requires a means to protect the cusps from the wedging forces of occlusion. When there is extensive loss of tooth structure, cuspal coverage is warranted. Usually this is in the form of indirect restoration. Traditionally, full coverage crowns have been used which would require further removal of sound tooth structure. Recently, adhesive alternatives have been introduced which allow for conservation of tooth structure.

Different materials can be used for this purpose. The evidence on the long-term survival of these materials is scarce. This study aims to investigate the short and medium-long term survival rate of these prostheses.


Eligibility criteria: Inclusion Criteria:

* Root canal treated molars with significant loss of tooth structure
* Supra-gingival margins
* Teeth scheduled for cuspal-covering indirect restorations

Exclusion Criteria:

* Teeth with extensive cracks or fractures
* Teeth with deep subgingival margins
* Non-functional teeth (no opposing dentition)
* Teeth with advanced periodontitis

Primary outcomes:
measure: Survival of Dental Prosthesis
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References: