louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00054808: Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma
Official title: A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Relapsed Lymphoma
Refractory Lymphoma
Low-Grade Lymphoma
Intermediate-Grade Lymphoma
Keywords: Gallium Nitrate
Ganite
NHL
Relapsed
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2003-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Eligible patients will have low- or intermediate-grade Non-Hodgkin's Lymphoma (NHL) that has progressed after standard chemotherapy. Patients will receive gallium nitrate 300 mg/m2/day by continuous IV infusion for 7 consecutive days using a portable infusion pump. Hospitalization is not required. Stable or responding patients will receive additional gallium nitrate infusions every 3 weeks until the time of disease progression, for a maximum total of 8 infusions, or 2 cycles after complete remission has been documented.

Detailed description: This study seeks to define the role of gallium nitrate in a specific population of patients who are expected to have received prior therapy. Preliminary clinical studies have suggested substantial evidence of antitumor activity in patients with relapsed or refractory non-Hodgkin's Lymphoma treated with gallium nitrate.

Eligibility criteria: Low- or intermediate-grade NHL using the International Working Formulation, subtypes IWF A-G:

Using the Updated REAL/WHO Classification, the following pathologic subtypes are eligible:

* Small lymphocytic lymphoma
* Lymphoplasmacytic lymphoma/immunocytoma
* Follicular lymphoma
* Diffuse large B-cell lymphoma
* Peripheral T-cell lymphoma, not otherwise characterized

Progression of disease following treatment with standard chemotherapy

Bi-dimensionally measurable disease

Performance Status: ECOG \< = 2

Patients with mantle cell lymphoma or mycosis fungoides are not eligible

Patients with known history of CNS metastasis are not eligible

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley Heights
country: United States
facility: Genta
state: New Jersey
Study officials:
References:
citation: Warrell RP Jr, Coonley CJ, Straus DJ, Young CW. Treatment of patients with advanced malignant lymphoma using gallium nitrate administered as a seven-day continuous infusion. Cancer. 1983 Jun 1;51(11):1982-7. doi: 10.1002/1097-0142(19830601)51:113.0.co;2-l.
Clinical trial NCT01326208: Strategies to Optimize Positive End-expiratory Pressure (PEEP) in Patients With Acute Lung Injury
Official title: Influence of Different Strategies to Optimize Positive End-expiratory Pressure on Pulmonary Gas Exchange, Perfusion/Ventilation Matching and Homogeneity of Ventilation in Patients With Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Lung Injury
Acute Respiratory Distress Syndrome
Respiratory Failure
Keywords: electrical impedance tomography
positive end-expiratory pressure
regional ventilation delay index
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study in patients suffering from acute lung injury is to determine whether positive end-expiratory pressure (PEEP) setting guided by electrical impedance tomography (EIT) influences pulmonary gas exchange, lung mechanics, ventilation/perfusion matching and homogeneity of regional ventilation when compared to other PEEP setting strategies such as the open lung concept or the ARDSnet protocol.


Eligibility criteria: Inclusion Criteria:

* acute lung injury, need for optimization of ventilatory settings

Exclusion Criteria:

* preexisting chronical lung disease, pneumothorax, pace maker, hemodynamical instability, increased intracranial pressure

Primary outcomes:
measure: homogeneity of regional ventilation delay
timeFrame: up to eight hours
Secondary outcomes:
measure: pulmonary gas exchange, lung mechanics and ventilation/perfusion matching
timeFrame: up to eight hours
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital
Study officials:
affiliation: University of Bonn
name: Christian Putensen, MD, Prof
role: STUDY_CHAIR
affiliation: University of Bonn
name: Thomas Muders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01088308: Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion
Official title: Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arrhythmias, Cardiac
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2010-03-17
Enrollment: 18
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 research study is a prospective, single-center, feasibility study designed to assess the possibility to detect hemodynamic changes during tachycardia episodes using tissue perfusion.

Detailed description: This study is being conducted to evaluate the feasibility to detect hemodynamic changes induced by supra-ventricular or ventricular tachycardia (SVT or VT) using tissue perfusion. Patients with a standard indication for either an electrophysiological study or an implantable cardioverter defibrillators(ICD) implant can be included into this study. Tissue perfusion and arterial blood pressure will be monitored and recorded throughout the electrophysiological procedure or ICD implant testing.

The study will be conducted in two consecutive phases. After completion of study phase I the study phase II will commence. Study phase I will be an acute non-invasive study in patients with an indication for an electrophysiological study, in whom tissue perfusion will be measured non-invasively with an epi-cutaneous tissue perfusion sensor. Phase II will be an acute invasive study in patients with an indication for the implantation of an ICD, in whom the tissue perfusion sensor will be placed in the surgically prepared device pocket on the muscular pectoralis or between the muscular pectoralis major and muscular pectoralis minor.

Eligibility criteria: Inclusion Criteria:

* Indication for: an electrophysiological study with ventricular stimulation OR the implantation of an implantable cardioverter defibrillator (ICD)
* Patient is at least 18 years old.
* Patient is able and willing to give informed consent.

Primary outcomes:
measure: Change in hemodynamic state during all tachycardia
timeFrame: <3 hours
Secondary outcomes:
measure: Change in hemodynamic state during SVT
timeFrame: <3 hours
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum
Study officials:
affiliation: Universitätsklinikum Aachen
name: Emilia Stegemann, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05854108: Comparison of Cervical Traction Versus Snag to Improve Pain and Quality of Life in Cervical Radiculopathy
Official title: Comparison of Cervical Traction Versus Snag to Improve Pain and Quality of Life in Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Cervical Radiculopathy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: For the wellness by Comparing of Cervical Traction Versus Snag to reduce Pain and improve Quality of Life in Cervical Radiculopathy


Eligibility criteria: Inclusion Criteria:

* Males and females were included. Age group 20-50 years. Patient suffering with neck pain radiating down the arms. Patients with positive Spurling test, cervical distraction and upper limb tension test.

Exclusion Criteria:

* Subject suffering with any systemic diseases of MSK. Patients already suffering with pain in shoulder and upper extremity which is of local origin.

Patient with cardiovascular or respiratory disease. Patients having osteophytes in cervical vertebrae. Hypermobility of cervical region.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 6 Months
measure: Quality of Life Scale QOL
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT06498908: Intracervical Balloon Placement With Nitrous Oxide Administration
Official title: Success Rate of Intracervical Balloon Placement With Nitrous Oxide Administration. A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Labor Pain
Induced; Birth
Keywords: pregnancy
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nitrous Oxide vs Oxygen
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled trial aims to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor.

Detailed description: This is a single center randomized controlled trial aimed to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor. Pregnant women requiring labor induction will be randomly assigned to receive either nitrous oxide or oxygen during the Foley balloon placement. The primary outcome measured will be the success rate of the Foley balloon placement, with secondary outcomes including patient comfort, pain levels during the procedure, and any adverse effects. The study seeks to determine if nitrous oxide can improve the success rate of Foley balloon placement compared to oxygen and to evaluate the overall patient experience and safety associated with its use in this context.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to labor and delivery for induction of labor (term inductions, medically indicated preterm inductions).
* Pregnant patients who are eligible for intracervical balloon placement.

Exclusion Criteria:

* Pregnant patients with contraindications to receiving nitrous oxide.
* Inability to safely self-administer nitrous oxide
* Allergy to nitrous oxide
* History of malignant hyperthermia,
* Concomitant administration of magnesium sulfate
* Less than 35 weeks gestational age
* Non-reassuring fetal heart tracing
* Use of intravenous or intramuscular opioid within 4 hours
* Vitamin B12 deficiency
* Gas-trapping conditions such as pneumothorax or small bowel obstruction
* Patients requesting neuraxial anesthesia
* Non-English speaking patients.

Primary outcomes:
measure: success rate of intracervical balloon placement
timeFrame: 15 minutes
Secondary outcomes:
measure: Pain Relief
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center OB/GYN
state: New York
Study officials:
References:
Clinical trial NCT01759108: Rebamipide AND Sjögren Syndrome
Official title: Rebamipide for the Treatment of Xerostomia in Sjögren Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Improving Symptoms of Dry Mouth in Sjőgren's Syndrome
Keywords: xerostomia
rebamipide
efficacy
safety
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2013-01-02
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Xerostomia is a major distressing symptom in Sjőgren's syndrome(SS). Preclinical and clinical studies have demonstrated an increase in saliva volume following rebamipide administration.We thus hypothesize that rebamipide may be efficacious in the treatment of dry mouth symptoms related to Sjőgren's syndrome.We will recruit SS patients in a randomized placebo-controlled trial for 12 weeks. The main outcome measure that will concern us is patient-assessed improvement of dry mouth symptoms and increase in salivary secretion Safety and efficacy was assessed at each visit.

Detailed description: Xerostomia is a major distressing symptom in Sjőgren's syndrome (SS). Persistent dryness of the mouth causes oral pain, discomfort and significantly interferes with the quality of life. Rebamipide, in addition to its gastro-protective effect has displayed various anti-inflammatory actions including inhibition of neutrophilic leukocyte activation. Preclinical and clinical studies have demonstrated an increase in saliva volume following rebamipide administration.

The aim of the present study is to assess efficacy of rebamipide in the treatment of dry mouth symptoms related to Sjőgren's syndrome.

Methods: Fifty-five patients with American European Consensus Criteria Group (AECG)-based diagnosis of SS will participate in this randomized placebo-controlled trial. Inclusion criteria will include SS patients with dry mouth symptoms. Patients with dry mouth due to other conditions will be excluded. Patients will be randomized 1:1 to receive either 300mg/d (100mg x3/day) of rebamipide or placebo for 12 weeks together with their usual therapy. Outcome measures will include patient-assessed improvement of dry mouth symptoms and increase in salivary secretion (evaluation of unstimulated saliva; questionnaires including the visual analogue scale (VAS) for Sicca-syndrome VAS 0-100mm). Subjective and objective findings of dry mouth will be recorded at baseline, two, four, six, eight, ten and twelve weeks. Safety and efficacy will be assessed at each visit.

Eligibility criteria: Inclusion Criteria:

* SS patients with dry mouth symptoms

Exclusion Criteria:

* Patients with dry mouth due to other conditions

Primary outcomes:
measure: improvement of dry mouth symptoms
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, University of Alexandria
Study officials:
affiliation: University of Alexandria
name: Anna Abou-Raya, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00756808: Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis (TB) in Elderly Residents of Nursing Homes?
Official title: Is Tuberculin Skin Testing Effective in Screening for Latent TB in Elderly Residents of Nursing Homes? Comparison With a New IFN-y Based Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: latent tuberculosis in elderly
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2008-09-22
Enrollment: 135
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 65 and older

Brief summary: In face of the increased rates of tuberculosis in residents of long term care facilities, annual screening for latent tuberculosis is recommended. Tuberculin skin testing using purified protein derivative (PPD) is used for this purpose. Sensitivity of the PPD testing is, however, dependent on a normal T cell function. It is now evident that the immune system undergoes age-associated alteration known as immune senescence. The depressed T-cell responses may clinically manifest as attenuated delayed-type hypersensitivity. This attenuated reaction may affect the sensitivity of the PPD in detection of latent TB in the elderly.

This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay, T-SPOT.TB, for detection of latent tuberculosis in nursing home patients who are 65 years of age or older.


Eligibility criteria: Inclusion Criteria:

* 65 years of age and older
* No ulcerating or blistering skin disorder
* No previous history of adverse reaction to PPD testing
* No blood transfusion within 6 weeks prior to enrollment
* If the participant had a PPD placed and read by a public health department representative within the last 6 months, repeat PPD will not be done, but the person may participate in the study
* Participant may have been Bacille de Calmette et Guerin (BCG)-vaccinated

Exclusion Criteria:

* Less than 65 years
* Not a resident of a long term care facility
* Diagnosis of Tuberculosis
* blood transfusion within 6 weeks of enrollment
* Prior diagnosis of immune deficiency

Primary outcomes:
measure: detection of latent TB
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Donna Seminara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01679808: Pressure Dependent Tracheal Obstruction in Copd Patients
Official title: Pressure Dependent Tracheal Obstruction in Copd Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheobronchomalacia
Keywords: copd
airway obstruction
Tracheobronchomalacia
Lead sponsor: LHL Helse
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (both sexes) in a pulmonary rehabilitation clinic

Brief summary: Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study. A garden hose was compressed from one side to simulate the posterior wall of the trachea bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was increasingly compressed in eight steps. Resistance was measured at each step for airflows 1 l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a computer to estimate the cross sectional area reduction and the corresponding distance between the bulging (posterior)and the opposite (anterior) wall (AP-distance).

Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy. The tracheal obstruction was observed during forced expiration and cough, and the cross sectional area reduction was estimated using the results from the model study.


Eligibility criteria: Inclusion Criteria:

* copd

Exclusion Criteria:

* clinical evidence of malignant disease
* not able to be subjected to bronchoscopy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: Glittreklinikken
state: Akershus
Study officials:
affiliation: LHL Helse
name: Ivar Ellingsen, Dr med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474408: Venous Function in Cardiovascular Disease Patients
Official title: Venous Function in Cardiovascular Disease Patients; The Neglected Part of Circulatory Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: Coronary artery bypass
Exercise therapy
Revascularization (PCI)
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary aim is to determine the acute effect of two different training interventions on venous plasticity in patients with myocardial infarction (MI), revascularization or coronary artery graft surgery compared to age-matched healthy subjects.

Detailed description: Compare the effect of 4 x 4 minutes at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate and moderate continuous exercise at 70 % of peak heart rate on venous function.

Eligibility criteria: Inclusion Criteria:

* myocardial infraction (MI)
* revascularization (PCI)
* coronary artery bypass graft surgery (CABG)

Exclusion Criteria:

* unstable angina pectoris
* uncontrolled hypertension
* orthopedic and/or neurological limitations
* participation in other studies
* MI (closer than 4 weeks)

Primary outcomes:
measure: Venous Compliance change
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Institutt for Sirkulasjon og Bildetechnikk, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, prof
role: STUDY_DIRECTOR
References:
citation: Leinan IM, Aamot IL, Stoylen A, Karlsen T, Wisloff U. Upper arm venous compliance and fitness in stable coronary artery disease patients and healthy controls. Clin Physiol Funct Imaging. 2017 Sep;37(5):498-506. doi: 10.1111/cpf.12324. Epub 2015 Dec 15.