louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06335316: Effect of Stellate Nerve Block in Dysphagia
Official title: Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-28
Enrollment: 122
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 randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.

Detailed description: Dysphagia is a frequent and potentially serious complication of stroke. This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
* Dysphagia.
* Age \>18 years.
* First-time stroke.
* Steady vital signs,
* Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

Exclusion Criteria:

* Allergy to Lidocaine injection or vitamin B12 injection;
* Severe cognitive impairment;
* Coagulation disorders;
* Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
* Complicated with other neurological diseases;
* Dysphagia caused by other diseases or reasons.

Primary outcomes:
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 10
Secondary outcomes:
measure: Yale Pharyngeal Residue Severity Rating Scale
timeFrame: day 1 and day 10
measure: penetration-aspiration scale
timeFrame: day 1 and day 10
measure: The Swallowing Quality of Life Questionnaire
timeFrame: day 1 and day 10
Other outcomes:
Locations:
city: Pengfu
country: Taiwan
facility: Huimin Hos.
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_CHAIR
References:
Clinical trial NCT00942916: Serum Inflammatory Marker in Patients With Diagnosis of Nontuberculous Mycobacterial Pulmonary Infection
Official title: Serum Inflammatory Marker in Patients With Diagnosis of Nontuberculous Mycobacterial Pulmonary Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nontuberculous Mycobacterial Pulmonary Infection
Keywords: Make sure the difference of the serum inflammatory marker between the two groups
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient was diagnosed as NTM pulmonary disease. They had satisfied at least microbiological, radiographical and clinical criteria.

Brief summary: This study is for those who had nontuberculous mycobacterial pulmonary infection with higher a serum inflammatory marker than those who had colonization.

Detailed description: Nontuberculous mycobacteria (NTM), not like Mycobacterium tuberculosis, is ubiquitous in environment including soil and water. Therefore, NTM pulmonary infection is not diagnosed only by microbiology of respiratory specimen but also clinical and radiographical findings.(1) Due to airway NTM colonization is not uncommon in sputum, diagnosis of pulmonary NTM infection is a big challenge in clinical practice. Especially NTM burden is increasing in recent literature.(2,3) Besides, the short-term mortality is reported higher in patients with NTM infection in medical ICU by Shu et al.(4) Early diagnosis and then treatment of NTM infection become important though NTM infection is considered as indolent process before.(1) Inflammatory marker in the patients with NTM being isolated from respiratory specimens is an indicator for differentiating true infection from colonization.(5,6) Those inflammatory factors might include blood white count, C-reactive protein, cytokines, procalcitonin , trigger receptor expressed on myeloid cell-1 (TREM-1) and Toll-like receptor-2. We therefore conduct this prospective study for analyzing

Eligibility criteria: Inclusion Criteria:

* more than 18 years
* study group : Satisfied the criteria for NTM pulmonary disease according to the ATS diagnosis guidelines.
* control groups: they had positive sputum culture for NTM but not fulfilled the diagnosis criteria

Exclusion Criteria:

* Those with bleeding tendency
* No inform consent
* Female with pregnancy

Primary outcomes:
measure: Diagnosis of NTM pulmonary disease according to the ATS guidelines
timeFrame: 2 year
Secondary outcomes:
measure: mortality
timeFrame: 2 year
Other outcomes:
Locations:
city: Yun-Lin County
country: Taiwan
facility: National Taiwan University Hospital, Yun-Lin Branch
Study officials:
affiliation: National Taiwan University Hospital
name: Chin-Chung Shu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00632216: A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis
Official title: Multicenter and Prospective Study to Determine the Satisfaction With Actonel (Risedronate Sodium) 35mg Once a Week Using Biochemical Markers of Bone as a Control, in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 464
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal outpatients women \> 55 and \< 70 years who have a clinical presentation appropriate for treatment of established osteoporosis based on the investigator's clinical judgment (a T-score for BMD (DEXA) of lumbar spine or femoral neck less than or equal to - 2.5 from an assessment performed at screening or within 12 months prior to the screening visit or evidence of previous vertebral fracture).

Exclusion Criteria:

* History of Cancer: Basal Cell or Squamous Cell carcinoma-documented 6-month remission.
* Diagnosis of hypocalcemia, hyperparathyroidism, hyperthyroidism.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: To determine the satisfaction of subject with Actonel 35 mg
timeFrame: Once a Week in the treatment of postmenopausal osteoporosis
Secondary outcomes:
measure: To measure response rates in CTX with Actonel 35 mg
timeFrame: Once A Week
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: YEU Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05335616: Behavioral Change Simulation Experiment Regarding Dentists' Repair Behavior
Official title: Behavioral Change Simulation Experiment Regarding Dentists' Repair Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Keywords: decision-making
repair behavior
questionnaire
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2022-04-19
Enrollment: 2944
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Either of two potential interventions is delivered as written instruction to the participants
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the present study is to determine the effect of two potential interventions on dentists' behavior regarding the repair of partially defective dental restorations.

Detailed description: Two potential interventions are delivered as written instructions to the participants. Dentists are asked to indicate their treatment preference for two given clinical scenarios (consisting of case vignettes, clinical photos, and radiographs) in two questionnaires prior (baseline data) and after receiving the intervention. Based on these data, the simulated behavior change (i.e. to repair or not to repair) will be assessed.

Eligibility criteria: Inclusion Criteria:

* General dentists, working in Germany and being listed in an address databse (www.adressdiscount.de)

Exclusion Criteria:

* Dentists who are not listed in the above-mentioned database
* Dentists who have previously declined to participate in future research from our department.

Primary outcomes:
measure: Simulated behavior change
timeFrame: 10 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology
state: Lower Saxony
Study officials:
References:
citation: Kanzow P, Kanzow AF, Wiegand A, Schwendicke F. Implementation of repairs in dental practice: Randomized behavior simulation trial. J Am Dent Assoc. 2023 Jul;154(7):610-619.e11. doi: 10.1016/j.adaj.2023.04.007. Epub 2023 May 22.
Clinical trial NCT02775916: Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CDZ173 in Patients With Primary Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Sjögren's Syndrome
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173 in patients with primary Sjögren's syndrome.

Detailed description: This study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173, a selective PI3K delta inhibitor, for 12 weeks, in patients with primary Sjögren's syndrome. Data from this study will provide the basis for further development of the compound for the treatment of primary Sjögren's syndrome.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary Sjögren's syndrome (pSS)
* ESSDAI score ≥ 6 at screening visit

Exclusion Criteria:

* Secondary Sjögren's syndrome

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85
timeFrame: up to Day 85
measure: Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85
timeFrame: Baseline and 12 weeks (Day 85)
Secondary outcomes:
measure: Change From Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) After 12 Weeks of Treatment Day 85
timeFrame: Baseline and 12 weeks (Day 85)
measure: Change From Baseline in the Short Form (36) Health Survey (SF-36) After 12 Weeks of Treatment Day 85
timeFrame: Baseline and 12 weeks (Day 85)
measure: Change in Baseline in Multidimensional Fatigue Inventory (MFI) After 12 Weeks of Treatment (Day 85)
timeFrame: Baseline and 12 weeks (Day 85)
measure: Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (Physician VAS) After 12 Weeks of Treatment Day 85
timeFrame: Baseline and 12 weeks (Day 85)
measure: Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) After 12 Weeks of Treatment Day 85
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
Study officials:
References:
Clinical trial NCT01885416: Impact of Dairy Products on Postprandial Inflammation
Official title: The Impact of Dairy Products on Postprandial Inflammation in Obese Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Obesity
Nutritional Intervention
Lead sponsor: Agroscope Liebefeld-Posieux Research Station ALP
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2013-06-25
Enrollment: 21
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic response to the ingestion of three different meals in obese subjects. The administered meals will differ in the proportion of dairy products. Postprandial response will be monitored during 6 hours after meal consumption.


Eligibility criteria: Inclusion Criteria:

* male
* BMI ≥ 20 kg/m2
* age 25-55 y
* informed consent

Exclusion Criteria:

* Physiological or psychological diseases
* Allergies to food or intolerance to high-fat meal
* Vegetarians
* Chronic intake of drugs
* Smokers
* Diabetes mellitus Type I and II
* Debilitating kidney diseases
* Debilitating liver diseases
* Clinically established coronary heart diseases
* Ingestion of vitamins or dietary supplements during the course of the study

Primary outcomes:
measure: Inflammation markers in blood plasma (IL-6, TNF-alpha)
timeFrame: 0,6h
Secondary outcomes:
measure: Biomarkers in blood (serum insulin, plasma glucose, GLP-1, lipids)
timeFrame: 0,1,2,4,6h
measure: Endotoxin in blood serum
timeFrame: 0,6h
Other outcomes:
measure: Blood cell transcriptome
timeFrame: 0,2,4,6h
measure: blood serum metabolome
timeFrame: 0,2,4,6h
Locations:
city: Bern
country: Switzerland
facility: University Hospital, Inselspital Berne
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Kur Laederach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Agroscope Liebefeld-Posieux ALP
name: Alexandra Schmid
role: STUDY_DIRECTOR
affiliation: Insel Gruppe AG, University Hospital Bern
name: Caroline Buri, MD, PhD
role: STUDY_DIRECTOR
affiliation: Agroscope Liebefeld-Posieux ALP
name: Guy Vergères, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01253616: Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
Official title: A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Tinnitus
Lead sponsor: MicroTransponder Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus. The study is expected to give preliminary efficacy and safety information.


Eligibility criteria: Key Inclusion Criteria:

* 18 to 65 years of age
* Diagnosed with subjective tinnitus due to hearing loss with at least some tonal quality of the tinnitus.
* Diagnosis of tinnitus for at least one year
* Tinnitus severity of 18 or greater on TRQ cross checked with TQ severity of Grade 3 or worse

Key Exclusion Criteria:

* Acute or intermittent tinnitus
* Severe hearing loss
* History of significant ear disease such as Meniere's disease, ear tumors, or evidence of active middle ear disease.
* Any other implanted device

Primary outcomes:
measure: Audiometric measurements
timeFrame: weekly through one month
Secondary outcomes:
measure: tinnitus questionaires
timeFrame: weekly through one month
measure: adverse events
timeFrame: as they occur
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
state: Edegem
Study officials:
References:
citation: De Ridder D, Vanneste S, Engineer ND, Kilgard MP. Safety and efficacy of vagus nerve stimulation paired with tones for the treatment of tinnitus: a case series. Neuromodulation. 2014 Feb;17(2):170-9. doi: 10.1111/ner.12127. Epub 2013 Nov 20.
citation: De Ridder D, Kilgard M, Engineer N, Vanneste S. Placebo-controlled vagus nerve stimulation paired with tones in a patient with refractory tinnitus: a case report. Otol Neurotol. 2015 Apr;36(4):575-80. doi: 10.1097/MAO.0000000000000704.
Clinical trial NCT00155116: SERPIN D1 and Its Role in Lung Cancer Invasion and Metastasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: To evaluate the correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Detailed description: Lung cancer is the leading cause of cancer death in Taiwan and world wild. Although there were progresses in the diagnosis and treatment of lung cancer, the incidence and mortality rate of lung cancer increased in recent years. In many cases, lung cancer is not diagnosed and treated until cancer cells have already invaded surrounding tissues and metastasized throughout the body. Only 15% of lung cancer patients were operable at presentation and about half of them had long term survival. The remaining almost died of metastatic disease. Detecting lung cancers when they are at their earliest stages, and identify cancers with metastatic potential will have a higher probability of truly curing the disease. Molecules that are expressed uniquely or at high level by tumor cells in comparison to normal tissues and that may be secreted into accessible fluids such as blood, urine, or sputum may be useful as lung cancer biomarkers. By using tools in SAGE Genie of Cancer Genome Anatomy Project (CGAP), we identified a secreted protein, SERPIN D1, as an overexpressed gene in non-small cell lung cancer as compared with normal lung and any other normal tissue. In an established panel of human lung adenocarcinoma cell lines with different invasive activities (CL1-0 cells and its sublines CL1-1, and CL1-5, in ascending order of activity), we detected that the expression of SERPIN D1 was higher in CL1-5 than in CL1-0 and CL1-1. According to our preliminary results, we hypothesize that SERPIN D1 may play a role in lung cancer invasion and metastasis and may serve as a serum biomarker for prognosis stratification. For this study, we are going to evaluate the potential correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Eligibility criteria: Inclusion Criteria:

* non-small cell lung cancer patient, pathological proved

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wei-Yu Liao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456716: Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma
Official title: A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: BAC lung cancer
adenocarcinoma of the lung
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
Collaborators: name: Bayer
name: Amgen
First posted: 2007-04-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open label study of sorafenib

Detailed description: Open label study using oral sorafenib 800 mg daily in any stage III-IV BAC lung cancer and Stage III-IV adenocarcinoma of the lung in nonsmokers (less than \< 100 cigarettes lifetime).

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Life expectancy \> 12 weeks
* Biopsy-proven BAC or adenocarcinoma
* Willing to provide smoking status
* Selected IIIB or stage IV cancer that is incompletely resected or unresectable

Exclusion Criteria:

* O2 saturation \< 88% on room air
* Pregnant or nursing women
* Surgery or radiation therapy within 4 weeks of starting study
* Major heart condition within 6 months of starting therapy
* Certain concomitant medications prohibited

Primary outcomes:
measure: Response rate
timeFrame: January 2009
measure: One-year survival
timeFrame: January 2009
measure: Median survival
timeFrame: January 2009
Secondary outcomes:
measure: Median progression-free survival
timeFrame: January 2009
measure: Toxicities
timeFrame: January 2009
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Swedish Cancer Institute
name: Howard J West, M.D.
role: PRINCIPAL_INVESTIGATOR
References: