louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04666779: Access to Chiropractic Care During the COVID-19 Pandemic
Official title: Access to Chiropractic Care During the COVID-19 Pandemic: a Prospective Comparative Cohort Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Access to Chiropractic Care Services
Lead sponsor: Real Centro Universitario Maria Cristina
Sponsor class: OTHER
Collaborators: name: University of Birmingham
name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Université du Québec à Trois-Rivières
First posted: 2020-12-14
Enrollment: 399
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chiropractic patients when the pandemic hit in Spain (March 2020), who consulted a chiropractor for pain as one of the chief complaints (not necessarily the main or the only one)

Brief summary: This is a prospective comparative cohort trial taking place during the first year of the Coronavirus-19 (COVID-19) pandemic in Spain. Chiropractic patients throughout Spain were invited to participate independently of the care received, including patients who had stopped visiting their chiropractors since the pandemic hit. The main exposure variable is the access to chiropractic care services, and the degree of this exposure during the months following initial lockdown phase in Spain. Participants will fill an online questionnaire with self-reported outcome-measures.


Eligibility criteria: Inclusion Criteria:

* chiropractic patients with pain, active when lockdown was declared, over the age of 16

Exclusion Criteria:

* new patients in the clinic after the pandemic hit

Primary outcomes:
measure: Pain intensity
timeFrame: 6 months
measure: Pain duration
timeFrame: 6 months
measure: Pain frequency
timeFrame: 6 months
measure: Pain perceived improvement
timeFrame: 6 months
measure: Pain interference
timeFrame: 6 months
measure: Pain Catastrophizing Scale
timeFrame: 6 months
measure: Tampa Scale Kinesiophobia
timeFrame: 6 months
Secondary outcomes:
measure: General Anxiety Disorder scale
timeFrame: 6 months
measure: Fear of Illness and Virus Evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: San Lorenzo De El Escorial
country: Spain
facility: Real Centro Universitario María Cristina
state: Madrid
Study officials:
affiliation: Real Centro Universitario María Cristina
name: Arantxa Ortega de Mues, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04644679: Monitoring Strategies for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke
Official title: 48-hour Versus 7-day Monitoring for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Atrial Fibrillation
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Randomized clinical trial comparing two monitoring strategies, the use of a 48-hour Holter (routine care branch) and an event recorder for 7 days (intervention branch).

Patients admitted for cryptogenic stroke will be included. Enrollment and randomization of patients will be carried out during the index case hospitalization, while follow-up will be done on an outpatient basis until day 7.

Detailed description: Once the diagnose of cryptogenic stroke have been carried out, informed consent will be taken and participants will be randomized to 48-hour monitoring arm or 7-day monitoring arm, followed by discharge from hospital.

Eligibility criteria: Inclusion Criteria:

* All patients who have studies that classify stroke or TIA as cryptogenic and who can carry out monitoring for 48 hours or 7 days will be included.
* Age ≥ 18 years

Exclusion criteria

* History of atrial fibrillation (or atrial flutter) documented.
* Patients who already have an event recorder in place, permanent pacemaker, or implantable cardioverter-defibrillator
* Evidence of lacunar infarction.
* Hemorrhagic stroke
* Patient for palliative care

Primary outcomes:
measure: Atrial fibrillation
timeFrame: 7 days
Secondary outcomes:
measure: Supraventricular arrhythmia
timeFrame: 7 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: C.a.b.a
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Gustavo Maid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05926479: Validation And Turkish Cross-Cultural Adaptation of Treatment Expectation Questionnaire (TEX-Q) Tool
Official title: Validation And Turkish Cross-Cultural Adaptation of Treatment Expectation Questionnaire (TEX-Q) Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physiotherapy Patients
Keywords: patient
expectation
validity
reliability
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who apply to physiotherapy clinic and will receive treatment for any indication

Brief summary: The general treatment expectations of patients play a significant role in determining the outcomes of the different treatments they undergo. When it comes to physiotherapy programs, these expectations act as non-specific treatment components, capable of triggering subjective psychological changes and eliciting mechanisms that resemble placebo effects. When theory-based, multidimensional measurement tools that evaluate patients' expectations from various treatments are examined, the Treatment Expectation Questionnaire (TEX-Q) questionnaire stands out. The aim of this study is to ensure the validity and reliability of the Turkish version of this form, which can be answered by every patient receiving various treatments, as an objective alternative and to be included among other treatment expectancy measurement tools.

Detailed description: This study includes the translation of the form after obtaining the relevant permissions, examining the internal consistency of the Turkish version, explanatory and confirmatory factor analysis, convergent validity and test-retest reliability processes.

The Turkish version of TEX-Q was applied to 200 patients who applied to the clinic for physiotherapy in the examination of internal consistency and exploratory factor analysis of the questionnaire. For convergent validity, 46 independent participants answered the Turkish version of the TEX-Q, the Positivity Scale, and the Hospital Anxiety and Depression Scale. The test-retest reliability within a 2-weeks interval was analysed in 63 of patients seeking physiotherapy program.

Eligibility criteria: Inclusion Criteria:

* ages between 18-65
* who would receive physiotherapy for at least 2 weeks for any indication

Exclusion Criteria:

* insufficient level of Turkish
* having any mental problems that would prevent participation in the study
* receiving another applied treatment other than the physiotherapy program

Primary outcomes:
measure: Treatment Expectancy Questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Positivity Scale
timeFrame: Baseline
measure: Hospital Anxiety and DepressionScale
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Bilgi University
state: Beyoglu
Study officials:
References:
Clinical trial NCT00565279: Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis
Official title: Efficacy and Safety of ASF 1057 Cream 0.5% in the Treatment of Seborrhoeic Dermatitis: A Phase III Randomised, Double-Blind, Vehicle and Placebo Controlled, Parallel Groups, Multi-Centre Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seborrheic Dermatitis
Keywords: Seborrhoeic dermatitis
Lead sponsor: Astion Pharma A/S
Sponsor class: INDUSTRY
First posted: 2007-11-29
Enrollment: 300
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 growing body of evidence supports the hypothesis that the pathophysiology of seborrhoeic dermatitis has a potentially causative neurogenic inflammatory aspect. ASF1057 is a new drug that acts through a modulation of neurogenic inflammation through important complementary mechanisms of action. This study will test the efficacy and safety of ASF1057 in the treatment of patients with seborrhoeic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of moderate to severe seborrhoeic dermatitis

Exclusion Criteria:

* Other active skin diseases
* Use of certain systemic and topical treatments
* Extensive sun exposure

Primary outcomes:
measure: Proportion of responders, defined as patients with OSS ≤ 1 score units.
timeFrame: Baseline, day 7, day 14, and day 21
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Astion Pharma A/S
name: Peder M Andersen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01815879: Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project
Official title: Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Liver Metastases
Keywords: metastatic colorectal cancer
liver metastases
90Y resin microsphere radioembolization
retrospective data analysis
Lead sponsor: Sarah Cannon
Sponsor class: INDUSTRY
Collaborators: name: Sirtex Medical
First posted: 2013-03-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal liver metastases in the USA treated with 90Y resin microsphere radioembolization

Brief summary: Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up.

Detailed description: Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up. Objectives:

Independent data collection and reporting of pre treatment and 12 week post treatment clinical, radiographic and radiation parameters and outcomes in patients treated in the USA from 2002-2010. Data beyond 12 weeks will be collected and highly desirable, however as a minimum all patients will have 12 week follow up.

Eligibility criteria: Inclusion Criteria:

* Patients who received 90Y resin microsphere radioembolization for metastatic colorectal cancer with liver metastases between November 2010 and March 2011 in the USA. Patients must have at least 12 weeks of follow up.

Exclusion Criteria:

* Patients who received glass 90Y microsphere radioembolization for metastatic colorectal liver metastases.

Primary outcomes:
measure: Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.
timeFrame: 3 months
Secondary outcomes:
measure: Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans.
timeFrame: 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Contact Sarah Cannon
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Andrew S Kennedy, MD, FACRO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00227279: A Trial of the ALK Grass Tablet in Subjects With Hayfever
Official title: A Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of ALK Grass Tablet in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Grass pollen allergy
Hayfever
Allergen immunotherapy
Specific immunotherapy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2005-09-28
Enrollment: 634
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: This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).


Eligibility criteria: Eligibility Criteria:

* A history of grass pollen induced rhinoconjunctivitis
* Positive skin prick test to grass
* Positive specific IgE to grass

Primary outcomes:
measure: Recording of rhinoconjunctivitis symptoms
timeFrame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009
measure: Recording of use of rescue medication
timeFrame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009
Secondary outcomes:
measure: Quality of life
timeFrame: Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital
Study officials:
affiliation: ALK-Abello A/S
name: Bente Tholstrup, MSc
role: STUDY_DIRECTOR
References:
citation: Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Rivas MF, Ribel M, Durham SR. Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006 Aug;118(2):434-40. doi: 10.1016/j.jaci.2006.05.003.
citation: Durham SR, Riis B. Grass allergen tablet immunotherapy relieves individual seasonal eye and nasal symptoms, including nasal blockage. Allergy. 2007 Aug;62(8):954-7. doi: 10.1111/j.1398-9995.2007.01402.x.
citation: Calderon MA, Birk AO, Andersen JS, Durham SR. Prolonged preseasonal treatment phase with Grazax sublingual immunotherapy increases clinical efficacy. Allergy. 2007 Aug;62(8):958-61. doi: 10.1111/j.1398-9995.2007.01416.x.
citation: Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Riis B, Gronager PM, Durham SR. Sublingual grass allergen tablet immunotherapy provides sustained clinical benefit with progressive immunologic changes over 2 years. J Allergy Clin Immunol. 2008 Feb;121(2):512-518.e2. doi: 10.1016/j.jaci.2007.10.039. Epub 2007 Dec 26.
Clinical trial NCT01610479: A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
Official title: A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

Detailed description: This is a phase 1, open-label, non-randomized, dose-escalating safety, tolerability, and pharmacokinetic study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

Eligibility criteria: Inclusion Criteria:

* Life expectancy of at least 3 months
* Histological or cytological documentation of advanced solid tumors
* ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
* Adequate bone marrow, liver and renal function
* Women of childbearing potential and men must agree to use adequate contraception

Primary outcomes:
measure: Maximum tolerated dose of TAS-114 when used in combination with S-1
timeFrame: 4 years
Secondary outcomes:
measure: Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, S-1 components and its metabolite)
timeFrame: 4 years
measure: Response rate
timeFrame: 4 years
measure: Disease control rate
timeFrame: 4 years
measure: Progression free survival
timeFrame: 4 years
Other outcomes:
Locations:
city: Kashiwanoha, Kashiwa-shi
country: Japan
facility: Site 01
state: Chiba
Study officials:
References:
citation: Doi T, Yoh K, Shitara K, Takahashi H, Ueno M, Kobayashi S, Morimoto M, Okusaka T, Ueno H, Morizane C, Okano N, Nagashima F, Furuse J. First-in-human phase 1 study of novel dUTPase inhibitor TAS-114 in combination with S-1 in Japanese patients with advanced solid tumors. Invest New Drugs. 2019 Jun;37(3):507-518. doi: 10.1007/s10637-018-0697-3. Epub 2018 Dec 4.
Clinical trial NCT00820079: ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
Official title: A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Study to Investigate the Efficacy, Mechanism of Action, Pharmacokinetics, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 as Monotherapy in Patients With Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal reflux
Heartburn
Regurgitation
Lead sponsor: Addex Pharma S.A.
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 120
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: Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.


Eligibility criteria: Inclusion Criteria:

* diagnosis of typical GERD
* well controlled on a standard clinical symptoms controlled dose of PPI treatment
* body mass index ≤32 kg/m2

Exclusion Criteria:

* exclusively atypical symptoms of GERD
* symptoms that have been shown not to be associated with GERD
* erosive oesophagitis
* hiatus hernia \> 3 cm
* current diagnosis of co-existing psychiatric disease
* known clinically significant allergy or known hypersensitivity to drugs
* pregnant or breast-feeding
* has received sodium valproate or topiramate within 30 days of Screening
* has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study

Primary outcomes:
measure: Number of GERD symptom free days in week 2 of study medication treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: GERD symptoms
timeFrame: 2 weeks
measure: Sleep disturbance
timeFrame: 2 weeks
measure: Use of antacid rescue medication
timeFrame: 2 weeks
measure: Global assessment of GERD
timeFrame: 2 weeks
measure: Effect on lower oesophageal sphincter and reflux episodes
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Wien
city: Leuven
country: Belgium
facility: Leuven
city: Bordeaux
country: France
facility: Bordeaux
city: Lyon
country: France
facility: Lyon
city: Nantes
country: France
facility: Nantes
city: Berlin
country: Germany
facility: Berlin
city: Dresden
country: Germany
facility: Dresden
city: Gorlitz
country: Germany
facility: Gorlitz
city: Leipzig
country: Germany
facility: Leipzig
city: Magdeburg
country: Germany
facility: Madgeburg 12
city: Magdeburg
country: Germany
facility: Magdeburg 13
Study officials:
References:
citation: Zerbib F, Bruley des Varannes S, Roman S, Tutuian R, Galmiche JP, Mion F, Tack J, Malfertheiner P, Keywood C. Randomised clinical trial: effects of monotherapy with ADX10059, a mGluR5 inhibitor, on symptoms and reflux events in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Apr;33(8):911-21. doi: 10.1111/j.1365-2036.2011.04596.x. Epub 2011 Feb 14.
Clinical trial NCT03277079: Low Dose Statins, Ezetimibe and Nutraceuticals
Official title: Low Dose Statins, Ezetimibe and Nutraceuticals in Coronary Artery Disease Patients Intolerant to High Intensity Statin Treatment (TArget ChOlesterol)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
LDL cholesterol
therapeutic target
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 100
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: It remains unknown if the association between moderate to low intensity statin therapy and ezetimibe and nutraceuticals might have a therapeutic role in high-intensity statin intolerant patients

Detailed description: The aim of this study will be to evaluate whether the association between statin and exetimibe vs statin + ezetimibe + nutraceuticals can lead to higher percentage of LDL target achievement

Eligibility criteria: Inclusion Criteria:

Patients with angiographically assessed diagnosis of coronary artery disease

Exclusion Criteria:

None

Primary outcomes:
measure: Therapeutic target
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University
Study officials:
affiliation: Sapienza University
name: Carlo Gaudio, MD
role: STUDY_CHAIR
References:
citation: Marazzi G, Campolongo G, Pelliccia F, Calabro Md P, Cacciotti L, Vitale C, Massaro R, Volterrani M, Rosano G. Usefulness of Low-Dose Statin Plus Ezetimibe and/or Nutraceuticals in Patients With Coronary Artery Disease Intolerant to High-Dose Statin Treatment. Am J Cardiol. 2019 Jan 15;123(2):233-238. doi: 10.1016/j.amjcard.2018.09.041. Epub 2018 Oct 19.