louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00737360: Phase II Study of TAS-106 to Treat Head and Neck Cancer
Official title: Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-08-19
Enrollment: 27
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: The purpose of this study is to determine whether TAS-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Age 18 ≤ years old at study entry
* Histologically confirmed head and neck carcinoma
* Received prior platinum based regimen and developed disease progression or recurrence
* Measurable disease according to RECIST guidelines

Exclusion Criteria:

* Radiological or clinical evidence of brain involvement or leptomeningeal disease
* ≥ grade 2 peripheral neuropathy
* History of another malignancy

Primary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: From the date of registration until the earliest date of documented disease progression, death, or censoring event.
Secondary outcomes:
measure: Antitumor Activity
timeFrame: Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.
measure: Overall Survival
timeFrame: 12 months after enrollment of the last patient
measure: Safety
timeFrame: Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.
Other outcomes:
Locations:
city: Orleans Street, Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Shatin, HKSAR
country: Hong Kong
facility: The Chinese University of Hong Kong, Prince of Wales Hospital
city: Lower Kent Ridge Road
country: Singapore
facility: National University Hospital
city: No. 1, Chang-De Street , Taipei
country: Taiwan
facility: National Taiwan University Hospital Department of Oncology
Study officials:
References:
Clinical trial NCT06882460: Diet and Exercise Solutions to Postprandial Hypotension
Official title: Lifestyle Solutions to Postprandial Hypotension in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: postprandial hypotension
electrical stimulation
low-glycemic diet
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 13
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: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if a low glycemic diet and lower-body electrical stimulation can reduce postprandial hypotension in individuals with chronic spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility
* AIS A or B
* \>1-year post-injury

Exclusion Criteria:

* Currently pregnant of breast-feeding
* Type 1 or 2 diabetes
* Previous gut augmentation bariatric surgery
* Neurological impairment other than SCI
* History of uncontrolled autonomic dysreflexia
* History of bone fractures
* Use of abdominal binder or anti-hypotensive drugs
* Fitted with pacemaker or defibrillator
* Currently receiving electrical stimulation training or in the previous year

Primary outcomes:
measure: Magnitude of systolic blood pressure decrease (in-lab)
timeFrame: Visit 2-4, Day 1
Secondary outcomes:
measure: Magnitude of systolic blood pressure decrease (at-home)
timeFrame: Visits 2-4, Days 1-3
measure: Postprandial glucose (in-lab)
timeFrame: Visits 2-4, Day 1
measure: Postprandial insulin (in-lab)
timeFrame: Visits 2-4, Day 1
measure: Postprandial glucose (at-home)
timeFrame: Visits 2-4, Day 1-3
measure: Blood flow (in-lab)
timeFrame: Visits 2-4, Day 1
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Dodd Rehabilitation Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02986776: Treatment Settings for Those With an Alcohol Problem
Official title: Treatment Settings for Alcoholics: A Field Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Alcohol-dependence
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 176
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: A prior study in a tightly controlled clinical research environment found individuals with an alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if they presented with high alcohol involvement and/or low cognitive functioning. This study sought to: (a) validate and extend these findings within the uncontrolled environment of a community-based treatment center, and (b) test whether inpatients had fewer days of involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need for inpatient treatment, using prior cut-points for alcohol involvement and cognitive functioning, participants were randomly assigned within inpatient need group (No Need for IP; Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient treatment, all followed by 6 months of continuing outpatient care. Follow-up were conducted an 90-day intervals across 18 months.


Eligibility criteria: Inclusion Criteria:

* Eligible for treatment through the Chemical Dependency treatment programs of a large, community-based healthcare network
* Drank alcoholic beverages within the last 90 days
* Have a current address (not homeless)
* Free of legal stipulations that would affect treatment decisions
* Have a past 3 months Alcohol Use Disorder
* Primary alcohol, or alcohol and drug problem

Exclusion Criteria:

* Homeless
* Drug problem only

Primary outcomes:
measure: Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)
timeFrame: Change up to 18 months
measure: Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview)
timeFrame: Change up to 18 months
measure: Monthly Drinks per Drinking Day (from Timeline Followback Interview)
timeFrame: Change up to 18 months
Secondary outcomes:
measure: Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)
timeFrame: Up to 18 months
Other outcomes:
Locations:
Study officials:
References:
citation: Rychtarik RG, McGillicuddy NB, Papandonatos GD, Whitney RB, Connors GJ. Randomized clinical trial of matching client alcohol use disorder severity and level of cognitive functioning to treatment setting: A partial replication and extension. Psychol Addict Behav. 2017 Aug;31(5):513-523. doi: 10.1037/adb0000253. Epub 2017 Feb 2.
Clinical trial NCT02877576: Single Neurons Responses During Visual Recognition in Epileptic Patients
Official title: Study of Cerebral Mechanisms of Visual Recognition With Single-unit Recordings of Intra-cerebral Neurons in Epileptic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose is to evaluate specific capacities of face detection of individual neurons by comparison with their capacity of object detection in medial temporal lobe and ventral temporal cortex in epileptic patients.

Secondary purpose is to evaluate specific capacities of detection of known faces of individual neurons by comparison with their capacity of detection of unknown faces in medial temporal lobe and ventral temporal cortex in epileptic patients.

Detailed description: In this interventional study, patients explored with mixed intracerebral electrodes (micro and macro-contacts) will be presented sets of images (objects, unknown faces, famous faces). Spikes and Multi-Unit-Activity will be recorded and analyzed and compared between conditions.

Eligibility criteria: Inclusion Criteria:

* Patient with temporal or occipito-temporal drug-resistant partial epilepsy, symptomatic, needing surgical treatment
* Patient having signed informed consent
* Patient affiliated to social security
* Patient having undergone preliminary medical examination

Exclusion Criteria:

* Persons under legal protection or incapable to consent
* Persons deprived of liberty by juridical or administrative decision
* Patient with severe visual disorders of neurological or ophthalmological origin
* Patients with infection risk according to doctor or surgeon
* Women without effective contraception
* Pregnant or breast-feeding women

Primary outcomes:
measure: Number of action potential (Difference of neuronal activity) generated successively by visual presentation of 60 photography of different unknown faces and 60 different objects
timeFrame: after electrode implantation, up to 12 days
Secondary outcomes:
measure: Number of action potential (Difference of neuronal activity) generated by visual presentation of 60 photography of a known target face (familiar) and 60 photography of unknown faces (non familiar)
timeFrame: after electrode implantation, up to 12 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: Service de Neurologie, Hôpital Central, CHRU de Nancy
Study officials:
affiliation: Service de Neurologie CHRU de Nancy - Hôpital Central
name: Louis MAILLARD, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03625076: IAL vs PS for Anterior Shoulder Dislocations
Official title: Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Shoulder Dislocation
Lead sponsor: Kendall Healthcare Group, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department.

Detailed description: This will be a single center, prospective, open-label, randomized controlled trial on a convenience sample of patients presenting to the ED with anterior shoulder dislocations. This study will enroll all patients between the ages of 18 and 70 who meet all of the inclusion criteria and do not meet any of the exclusion criteria, who present to the ED with an anterior shoulder dislocation as determined by the ED physician. Written, informed consent will be obtained from each patient. After enrollment, each patient will be randomized either to IV sedation (with the provider's choice of propofol or etomidate) or intra-articular lidocaine. Randomization will be done before the initiation of data collection, and will be done with a random number generator. Patients who are randomized to the intra-articular group will receive 20 mL of 1% lidocaine injected into the glenohumeral joint using a lateral approach. Treating clinicians will be instructed to wait 10 minutes after injection before attempting reduction. The primary outcome measure will be the difference in emergency department length of stay between the procedural sedation and intra-articular lidocaine groups.

Eligibility criteria: Inclusion Criteria:

* Patients 18-70 years old in the emergency department with an anterior shoulder dislocation.

Exclusion Criteria:

* Pregnant or breastfeeding
* Is a prisoner.
* Known allergy to one of the study drugs.
* Altered mental status.
* Shoulder fracture (other than a Hill-Sachs) associated with the dislocation.
* Attending provider excludes patient.

Primary outcomes:
measure: Emergency Department Length of Stay
timeFrame: Anticipated 1-4 hours
Secondary outcomes:
measure: Number of Reduction Attempts
timeFrame: Each attempt takes under 5 minutes
measure: Patient Satisfaction
timeFrame: The patient is asked their satisfaction just prior to discharge (generally within 4 hours)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Kendall Regional Medical Center
state: Florida
Study officials:
References:
Clinical trial NCT03177876: Sinus Lift With Hydroxyapatite Nano Particles Versus Tenting Technique
Official title: Schneiderian Membrane Elevation and Augmentation With Hydroxyapatite Nano Particles [ Nano Streams ] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Sinus Lift
Keywords: tenting Hydroxyapetite nano particles implant immediate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 20
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: twenty recruited patients indicated for sinus augmentation and immediate implant placement will be divided into two groups (10 in each of the two groups), to compare bone formation and implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles \[Nanostreams\] or augmentation with graft less tenting technique with simultaneous implant placement.


Eligibility criteria: Inclusion Criteria:

* Patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm of residual ridge as per MISCH criteria
* Both sexes

Exclusion Criteria:

* Sinus pathology
* Heavy smokers more than 20 cigarettes per day
* Patients with systemic disease that may affect normal healing

Primary outcomes:
measure: patient satisfaction
timeFrame: 7 days post operative
Secondary outcomes:
measure: implant stability
timeFrame: will be measured intra-operative after implant insertion and will be measured one more time 6 months after the first operation at the time of implant exposure
measure: height of bone gain or loss around the implant
timeFrame: 6 months post operative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03768076: an Istitution Experience on Parosteal OsTeosarcoma
Official title: Parosteal OsTeosarcoma: a Single Istitution Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parosteal Osteosarcoma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female with diagnosis of parosteal osteosarcoma treated at Rizzoli institute from 01 Jan 1900 to 31 Jul 2018

Brief summary: single institution cases series review of histological and clinical data

Detailed description: Investigators will review all the cases with a diagnosis of primary parosteal osteosarcoma treated at the Rizzoli Institute from 1900 up to 31 July 2018, retrospectively.

Eligibility criteria: Inclusion Criteria:

* Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Jul 2018
* Diagnosis of parosteal osteosarcoma
* Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

• Patients with histological diagnosis different from parosteal osteosarcoma

Primary outcomes:
measure: retrospective analysis of cases of Parosteal osteosarcoma
timeFrame: at baseline (Day0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto ortopedico Rizzoli
Study officials:
References:
citation: Han I, Oh JH, Na YG, Moon KC, Kim HS. Clinical outcome of parosteal osteosarcoma. J Surg Oncol. 2008 Feb 1;97(2):146-9. doi: 10.1002/jso.20902.
citation: Bertoni F, Bacchini P, Staals EL, Davidovitz P. Dedifferentiated parosteal osteosarcoma: the experience of the Rizzoli Institute. Cancer. 2005 Jun 1;103(11):2373-82. doi: 10.1002/cncr.21039.
citation: Okada K, Frassica FJ, Sim FH, Beabout JW, Bond JR, Unni KK. Parosteal osteosarcoma. A clinicopathological study. J Bone Joint Surg Am. 1994 Mar;76(3):366-78. doi: 10.2106/00004623-199403000-00007.
citation: Laitinen M, Parry M, Albergo JI, Jeys L, Abudu A, Carter S, Sumathi V, Grimer R. The prognostic and therapeutic factors which influence the oncological outcome of parosteal osteosarcoma. Bone Joint J. 2015 Dec;97-B(12):1698-703. doi: 10.1302/0301-620X.97B12.35749.
Clinical trial NCT00154076: A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 140
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies


Eligibility criteria: Inclusion criteria:

1. Patients over 13 years old (complete the elementary school course).
2. Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening.
3. Patients had no antiepileptic drugs for the last 4 months.
4. Women of childbearing age who agree to contraception during participating this clinical trial.

Exclusion criteria:

1. Pregnancy
2. Patients who have progressive neurologic disease
3. Allergy to sulfonamides
4. Use of acetazolamide within a year
5. Hemolytic anemia
6. Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values.
7. Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values.
8. Patients who have history of drug or alcohol abuse.
9. Glucose-6-phosphate dehydrogenase deficiency.
10. Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test.
11. Patients who have progressive internal or surgical disease.
12. Patients who have progressive psychiatric disease.
13. Patients who have mental retardation (IQ 70 and less).
14. Patients taking Vit C.

Primary outcomes:
measure: Seizure frequency
timeFrame: 2, 4, 8, 12, 16, 20, 24 weeks
Secondary outcomes:
measure: Cognitive function
timeFrame: 0, 24 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Eisai Korea Inc.
name: Jihee Mun
role: STUDY_DIRECTOR
References:
Clinical trial NCT01746576: Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether analysis of near infrared absorbance signals that occur at different frequencies might provide information about the difference in oxygen saturation between arterial and venous blood.


Eligibility criteria: Inclusion Criteria:

* Adult 18-65 years of age

Exclusion Criteria:

* Dilated cardiomyopathy
* Congestive heart failure
* Pulmonary hypertension
* Severe aortic stenosis
* Flail chest
* Chest pain
* Shortness of breath

Primary outcomes:
measure: Estimated venous oxygen saturation
timeFrame: From 5 to 6:59 minutes after applying the impedance threshold device
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
citation: Thiele RH, Tucker-Schwartz JM, Lu Y, Gillies GT, Durieux ME. Transcutaneous regional venous oximetry: a feasibility study. Anesth Analg. 2011 Jun;112(6):1353-7. doi: 10.1213/ANE.0b013e3182166a26.
Clinical trial NCT01234376: Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis
Official title: Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with eosinophilic esophagitis who underwent EGD for the evaluation of their symptoms.

Control patients who underwent EGD because of other reasons.

Brief summary: Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of the gut at a subcellular resolution. Various studies have addressed the potential of endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis.

The purpose of this study is to determine whether endomicroscopy is effective for the in vivo diagnosis of eosinophilic esophagitis.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing EGD

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Impaired renal function (Creatinine \> 1.2 mg/dl)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Known allergy to fluorescein, acriflavin or cresyl violet
* Residing in institutions (e.g. prison)

Primary outcomes:
measure: Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis
timeFrame: November 2010 - November 2012
Secondary outcomes:
measure: Differentiation of mucosal alterations in patients with eosinophilic esophagitis compared to patients with gastroesophageal reflux disease.
timeFrame: November 2010 - November 2012
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg
state: Bayern
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Markus F. Neurath, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Erlangen-Nürnberg
name: Helmut Neumann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: