louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00418431: Intravitreal Bevacizumab for the Treatment of Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Central Serous Chorioretinopathy
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Central serous chorioretinopathy (CSC) has been known since it was first described by Von Graefe and termed "idiopathic detachment of the macula" in 1866, is a well-characterized disorder leading to serous neurosensory elevation of the central macula. The acute form of the disease is associated with focal leakage at the level of the retinal pigment epithelium (RPE) demonstrated with fluorescein angiography (FA). The disorder is self-limited in the majority of patients, who also regain excellent vision. Occasionally, the neurosensory detachment persists and leads to pigment epithelial and photoreceptor damage with visual impairment.

The purpose of this clinical study is report the use of intravitreal bevacizumab is a new option in the treatment of the chronic or recurrent CSC.


Eligibility criteria: Inclusion Criteria

* Any visual acuity.
* Central serous chorioretinopathy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico DF
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Mitzy E Torres Soriano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02194673: Acute Effects of Natural and Interesterified Fats-margarine on Lipemic and Insulinemic Response
Official title: Acute Effects of Natural and Interesterified Fats-formulated Margarine on Lipemic and Insulinemic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: International Medical University
name: Universiti Putra Malaysia
First posted: 2014-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and insulinemic responses compare to a trans free palm margarine (TFPM).

Detailed description: The objective of this study was to investigate whether IE-fat blends behave differently on postprandial serum lipid, insulin, C-peptide and glucose concentration compare to TFPM. A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults. During postprandial challenge day, each subject received an a test muffin incorporated with test margarine. Blood samples were collected at half-hourly intervals until 4 hr by using cannulation technique.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 18.5 and 24.9
* \<130mmHg for systolic pressure and \<80 mmHg for diastolic pressure
* Blood glucose level in the range of 3.9 to 5.5 mmol/L
* Total cholesterol less than 5.17 mmol/L
* No use of tobacco and no consumption of alcohol.

Exclusion Criteria:

* Suffer from chronic disease
* Metabolic syndrome
* Consuming any medical prescriptions
* People with blood clotting problem
* Women who are pregnant
* Hypertensive person

Primary outcomes:
measure: Change in serum triglycerides level of subjects as a measure of postprandial triglycerides response
timeFrame: Baseline, 4 hours
Secondary outcomes:
measure: Change in the level of plasma insulin, c-peptide and serum glucose as a measure of postprandial insulinemic response
timeFrame: Baseline, 4 hours
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: MalaysiaPOB
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: Voon Phooi Tee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04055831: Immune Biomarkers Related to Bone Pathology in Patients With Type 1 Gaucher Disease
Official title: Immune Biomarkers Related to Bone Pathology in Patients With Type 1 Gaucher Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gaucher Disease Type 1
Keywords: Gaucher disease
Osteoporosis
Lead sponsor: Lysosomal and Rare Disorders Research and Treatment Center, Inc.
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically confirmed GD1 patients will be stratified based on their disease severity and bone density findings.

Brief summary: Bone-related problems represent the principal unmet medical need in Gaucher disease (GD). 75% of GD type 1 patients develop skeletal complications, including bone remodeling defects, osteopenia, osteoporosis, marrow infiltration, avascular necrosis, and osteolysis. However, the underlying cellular/molecular basis of bone involvement and related complications in GD are not fully known. Neither are there any bone-specific markers associated with individual bone pathology. Early diagnosis of bone disease is the key issue for planning individual therapy to prevent and reverse bone disease in GD.

Detailed description: This clinical observational study is designed to identify specific biomarkers for bone involvement in patients with GD1 with decreased bone density and/or bone structural abnormalities

Aims:

1. Identify novel immune cell surface and biochemical markers in peripheral blood correlating with bone involvement in GD.
2. Assess the correlation between cytokine levels in peripheral blood and the severity of bone involvement in GD.
3. Assess the relationship between glycosphingolipids accumulation and macrophage activation with specific bone markers and GD severity.

Eligibility criteria: Inclusion Criteria:

* To be enrolled in this study the subject must meet the following criteria

  1. Subject is greater than 16 years old but not older than 90 years
  2. Signed Informed Consent/Assent
  3. Subject is able and willing to sign informed consent or assent
  4. If the subject has GD1, the must have a confirmed diagnosis of Gaucher disease by

     * GCase enzyme activity
     * DNA analysis demonstrating pathogenic variants in the GBA gene

Exclusion Criteria:

* a) Have evidence of hepatitis B, hepatitis C infection or any other chronic infectious disease b) Be pregnant or breastfeeding

Primary outcomes:
measure: Measure biomarkers level in molar/l/h
timeFrame: 18 months
measure: Measure biomarkers level: molar/mg/h
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: LDRTC
state: Virginia
Study officials:
affiliation: Lysosomal and Rare Disorders Research and Treatment Center
name: Ozlem Goker-Alpan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412031: Prediction of Unfavourable Outcome in Newly Covid-19 Hospitalized Patient
Official title: Bayesian Network to Predict Transfer in Intensive Care Units or Death in Newly Covid-19 Hospitalized Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: to Predict an Unfavorable Evolution of Covid-19 at the Hospital Admission of Patients
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 802
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The project is a part of the "Protocol for a multicentre study of nosocomial SARS-CoV2 transmission: The NOSO-COR Project"

It is an international multicentre prospective, observational, hospital-based study in adults. It will include volunteer patients, care givers and healthcare professionals in France and hospitals affiliated with the GABRIEL network. Demographic and clinical data will be collected using case-report forms designed especially for the purpose of the project. A nasopharyngeal swab will be collected and tested for SARS-CoV2 by RT-PCR. Characteristics of the study participants, the proportion of confirmed nosocomial SARS-CoV2 infections relative to all patients with syndromes suggestive of 2019-nCoV infection will be analyzed.

Brief summary: The project is a part of the "Protocol for a multicentre study of nosocomial SARS-CoV2 transmission: The NOSO-COR Project" registered in ClinicalTrials (NCT04290780).

In the current pandemic context, medical resources have often been exceeded. Developing, using artificial intelligence techniques, an algorithm capable of detecting patients at risk of acute respiratory distress following Sars-Cov2 infection could help physicians to optimize the treatment of patients and health decision-makers to optimize resources. Thus, the goal of this project is to create a prediction model using artificial intelligence to predict an unfavorable evolution of Covid-19 at the hospital admission of patients


Eligibility criteria: Inclusion Criteria:

* Participant must be 18 years or older at the time of signing the informed consent
* Volunteer patients, care givers and healthcare professionals in France and hospitals affiliated with the GABRIEL network. Demographic and clinical data will be collected using case-report forms designed especially for the purpose of the project.
* A nasopharyngeal swab will be collected and tested for SARS-CoV2 by RT-PCR.
* Admission to hospital

Exclusion Criteria:

* Age lower than 18 years old
* Patients protected by the law

Primary outcomes:
measure: Need of mechanical ventilation, transfer to an intensive care unit or death within 21 days of admission.
timeFrame: within 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital E Herriot - Hospices Civils de LYON
Study officials:
References:
Clinical trial NCT04928131: Risk Factors for Long-term Opioid Use
Official title: Opioid Use Among Patients With Pain Syndromes Commonly Seeking Surgical Consultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 1500392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients enrolled in private health insurance included within the Marketscan database, who generated at least one insurance claim for anorectal, foot/ankle, or TMJ pain.

Brief summary: Surgeons often see patients with pain to exclude organic pathology and consider surgical treatment. We examined factors associated with long-term opioid therapy among patients with foot/ankle, anorectal, and temporomandibular joint pain to aid clinical decision making.

Using the IBM MarketScan® Research Database, we conducted a retrospective cohort analysis of patients aged 18-64 with a clinical encounter for foot/ankle, anorectal, or temporomandibular joint pain (January 2007-September 2015). Multivariable logistic regression was used to estimate adjusted odds ratios for factors associated with long-term opioid therapy, including age, sex, geographic region, pain condition, psychiatric diagnoses, and surgical procedures in the previous year.


Eligibility criteria: Inclusion Criteria:

* 18-64 years old
* at least one encounter for anorectal, foot/ankle, or TMJ pain
* Marketscan continuous enrollment for 1 year prior and 1 year after the index pain encounter

Primary outcomes:
measure: Long-term opioid use
timeFrame: >90 days of opioid supply
Secondary outcomes:
measure: new long-term opioid use
timeFrame: >90 days of opioid supply
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05623631: Delphi Study to Identify Crucial Steps and Errors in the Placement of Chest Tubes
Official title: Delphi Study to Identif Crucial Steps and Errors in the Placement of Chest Tubes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Injury
Keywords: Assessment
Chest Tube Insertion
Rating Scale
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this Delphi study is to identify the crucial steps and the errors in Chest Tube Insertion (CTI). These steps and errors will be used for the development of a new assessment tool based on international consensus.


Eligibility criteria: Inclusion Criteria:

* Must be experts in their respective fields.
* Must hold a degree of Master in Medicine
* Must have finished the residency training specific to their field (be an attending physician)
* Must have 5 years post-residency experience
* Must have performed at least 50 CTIs independently in their career
* Must have an interest in educating and guiding junior residents in their training.

Exclusion Criteria:

* Insufficient experience in CTI
* Insufficient experience as an attending physician

Primary outcomes:
measure: Steps and errors presented in round 1
timeFrame: one year
measure: Number of steps and errors passing round 2
timeFrame: one year
measure: Inclusion of steps with their descriptive anchors
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Wouter Willaert, Prof, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04786327: Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect
Official title: Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Regeneration
Keywords: Chronic periodontitis
Intra-bony defects
Minimally invasive surgical technique
Platelet rich fibrin,
Growth factor enhanced matrix 21S
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density

Detailed description: : Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density.

Eligibility criteria: Inclusion Criteria:

• Presence of at least one tooth with PPD and CAL loss of ≥ 5 mm associated with an intra-bony defect of ≥ 2 mm according to Cortellini and Tonetti, 2007

Exclusion Criteria:

* Patients with uncontrolled or poorly controlled diabetes, life-threatening conditions, or requiring antibiotic prophylaxis were excluded.
* Smokers
* Pregnant patients.
* Patients with aggressive periodontitis.
* Patients with multiple interconnected vertical defect walls.

Primary outcomes:
measure: the change in probing pocket depth
timeFrame: 9 months
measure: the change bleeding on probing score
timeFrame: 9 months
measure: the change Clinical attachment level
timeFrame: 9 months
measure: Cone beam radiograph
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Malak Mohamed Shoukheba
Study officials:
affiliation: tanta university faculty of dentistry
name: malak m shoukheba, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00833027: ALPHA Sitagliptin Add on to Metformin (0431-103)
Official title: A 24 Week, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Adding Sitagliptin 100 mg Once Daily in Patients With T2DM Who Have Inadequate Glycemic Control on Metformin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 608
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: Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin


Eligibility criteria: Inclusion Criteria:

Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study Entry

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00723827: Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
Official title: Temodal (Temozolomide) Post Marketing Surveillance Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Glioma
Astrocytoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 682
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with newly diagnosed glioblastoma multiforme.

Participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Brief summary: The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt:

* Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events);
* Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction);
* Adverse Event caused by misuse, abuse, or drug interactions;
* Other information concerned with safety or efficacy.


Eligibility criteria: Inclusion Criteria:

* Participants who are prescribed with temozolomide by local labeling:

  * participants with newly diagnosed glioblastoma multiforme;
  * participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
measure: Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)
timeFrame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
measure: Number of Temozolomide Misuse or Abuse Events
timeFrame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
measure: Number of Temozolomide Drug Interactions
timeFrame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
measure: Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)
timeFrame: Complete study duration (up to approximately 6.5 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04093427: Influence of an Inverse Pressure Ramp in Long-term Non-invasive Ventilation on Dyspnea in the Morning After Therapy
Official title: Einfluss Einer Inversen Druckrampe Bei Der Langzeit-Therapie Mit Nicht-invasiver Ventilation Auf Dyspnoe am Morgen Nach Therapie-Ende. Influence of an Inverse Pressure Ramp in the Long-term Therapy Mit Non-invasive Ventilation on Dyspnea in the Morning After Therapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Noninvasive Ventilation
Dyspnea
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
Collaborators: name: Löwenstein Medical Technology GmbH & Co. KG
First posted: 2019-09-18
Enrollment: 8
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: Patients being treated with non-invasive home mechanical ventilation (NIV) may experience morning dyspnea after each night of NIV use, when the therapy is abruptly ended. This study aims to show that dyspnea intensity can be significantly reduced by a gentle NIV therapy end, delivered by a continuously decreasing pressure level (inverse pressure ramp) after therapy end in the morning, a feature called softSTOPP, which can configured in prismaVENT NIV devices. This could also improve therapy adherence.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of a chronic obstructive pulmonary disease (COPD) with chronic hypercapnic insufficiency
* Therapy with prismaVENT 30, firmware V 3.3 or higher, mode S/T, stable device settings at the time of inclusion without need to adapt ventilation parameters
* May have co-existing obstructive sleep apnea syndrome
* Subjective dyspnea ≥3 (Borg scale) after end of ventilation therapy in the morning
* Written informed consent for study participation including data protection

Exclusion Criteria:

* Missing written informed consent for study participation including data protection
* Contraindication for positive airway pressure therapy
* Use of the softSTOPP feature before study inclusion
* Participation in another study, which influences NIV therapy by defining device settings or titration
* Concomitant oxygen therapy

Primary outcomes:
measure: Change of dyspnea level from baseline to 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Krankenhaus Bethanien
state: NRW
Study officials:
affiliation: Krankenhaus Bethanien
name: Winfried J Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: