louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04820582: Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis
Official title: Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis: A Delphi Study Conducted by the Study Group VALue Based HEalth CaRe In Endometriosis (VALHERIE).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis
Delphi Study
Patient Reported Outcome Measures (PROMs)
Clinician Reported Outcome Measures (CROMs)
Lead sponsor: One Clinic
Sponsor class: OTHER
Collaborators: name: Poissy-Saint Germain Hospital
name: Versailles Saint-Quentin-en-Yvelines University
name: PointGyn
First posted: 2021-03-29
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A group of international experts comprising patients experts, gynecologists, radiologist, psychologists, nurses and researchers, that have been identified based on their expertise in the field or due to their active role in an endometriosis patient association

Brief summary: Endometriosis is a chronic disease that affects one out of 10 women. Endometriosis care is full of variation. Recommendations for optimal management vary between clinician and centers. One way of dealing with this unwanted variation is the shift towards a value -based endometriosis care. Value-based healthcare (VBHC) is a strategy focused on the optimization of the balance between outcomes that are important to patients and cost to achieve these outcomes. To do so, for a given condition it is important to define a standardized set of outcomes metrics allowing quality of care monitoring and comparison in order to optimize clinical practices and patient pathways. A common set of outcomes combining clinical outcomes (Clinical Reported Outcome Measures, CROMs) as well as quality of life and functional recovery indicators through Patient Reported Outcome Measures (PROMs). Different standardized data sets have already been developed to measure outcomes in other pathologies, however a standardized set of outcome measurements have not yet been determined for endometriosis. The objective of this study is to determine a standard set of outcome measurements for endometriosis.


Eligibility criteria: Inclusion Criteria:

* Profession: gynecologists, radiologist, psychologists, nurses and researchers having an expertise in the field of endometriosis
* Patient experts having an active role in an endometriosis patient association

Exclusion Criteria:

* Retirement

Primary outcomes:
measure: Agreement on a list of PROMs and CROMs that are relevant and feasible in endometriosis care by the expert panel
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poissy
country: France
facility: Hopital Intercomunal Poissy Saint Germain en Laye
Study officials:
References:
Clinical trial NCT00218582: Effectiveness of Self-Help for Dually-Diagnosed Persons - 1
Official title: Effectiveness of Self-Help for Dually-Diagnosed Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dual Diagnosis
Substance-Related Disorders
Mental Disorders
Keywords: 12 step groups
self help
psychiatric day treatment
co-occurring disorders
dual diagnosis
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: National Development and Research Institutes, Inc.
First posted: 2005-09-22
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of adding dual focus 12-step self-help groups to standard treatment to improve behavioral outcomes for patients dually diagnosed with substance abuse and psychiatric disorders.


Eligibility criteria: Inclusion Criteria:

Admission to psychiatric day treatment program 18-64 years old

Exclusion Criteria:

Did not understand or speak English, appeared intoxicated on drugs or alcohol, carried a diagnosis of mental retardation, were deemed actively psychotic by the clinic's intake coordinator, appeared unable to understand and give informed consent.

Primary outcomes:
measure: drug/alcohol use
timeFrame: past 90 days
Secondary outcomes:
measure: psychiatric medication adherence
timeFrame: recent
measure: traditional 12 step meeting attendance
timeFrame: past 90 days
measure: psychiatric symptoms
timeFrame: recent
measure: program retention
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein Dept of Psychiatry
state: New York
Study officials:
affiliation: National Development and Research Institutes, Inc.
name: Stephen Magura, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magura S, Rosenblum A, Villano CL, Vogel HS, Fong C, Betzler T. Dual-focus mutual aid for co-occurring disorders: a quasi-experimental outcome evaluation study. Am J Drug Alcohol Abuse. 2008;34(1):61-74. doi: 10.1080/00952990701764623.
Clinical trial NCT02093182: An Innovative Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm
Official title: A Retrospective, Open-Label, Non-Randomized, Study Designed to Evaluate the Correlation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Vasospasm Patients After Sub Arachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sub Arachnoid Hemorrhage
Vasospasm
Lead sponsor: HeadSense Medical
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SAH patients with an expected TCD test

Brief summary: The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy, highly operator dependent and more.

HS-1000 device, an investigational vasospasm detection device, has the potential to safely diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality for vasospasm measurement tool.

We aim to evaluate the correlation between the collected and analyzed data from the HS-1000 device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH) patients.


Eligibility criteria: Inclusion Criteria:

* SAH patients with a TCD test
* Male or Female in the age range of 18-85 years
* Expected survival \> 14 days

Exclusion Criteria:

* Local infection in the ear.
* Pregnant/lactating women
* Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
* Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
* Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition) Note: As the trial does not affect the patient's management, there is no limitation regarding patient's medications, previous or post study procedures, etc.

Enrolled patients treatment will not change due to their participation in the trial

Primary outcomes:
measure: Accuracy analysis
timeFrame: within the first 30 days
Secondary outcomes:
measure: Safety analysis
timeFrame: within the first 48 hours
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT02988882: OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Official title: A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Allergic Conjunctivitis
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2016-12-09
Enrollment: 86
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: The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis


Eligibility criteria: Inclusion Criteria:

* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
* Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

* History of refractive surgery (including LASIK procedures) within the past 2 years
* History of retinal detachment, diabetic retinopathy, or active retinal disease
* Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
* Use any of the disallowed medications during the period indicated
* History of IOP increase as a result of steroid treatment

Primary outcomes:
measure: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
timeFrame: 3 minutes
measure: Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6
timeFrame: 5 minutes
measure: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
timeFrame: 7 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01510782: Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (0.2 mg to 120 mg Administered by Intravenous Infusion and 40 mg to 120 mg Administered by Subcutaneous Injection) of BI 655064 (Buffer Solution for Injection) in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-01-16
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Changes in vital signs (blood pressure [BP], pulse rate [PR])
timeFrame: up to 70 days post treatment
measure: Changes in 12-lead ECG (electrocardiogram)
timeFrame: up to 70 days post treatment
measure: Incidence of adverse events
timeFrame: up to 70 days post treatment
measure: Assessment of global tolerability by investigator
timeFrame: up to 70 days post treatment
measure: Assessment of local tolerability by investigator
timeFrame: up to 70 days post treatment
Secondary outcomes:
measure: Maximum measured concentration of the analyte in plasma
timeFrame: up to 1656 hours post treatment
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
timeFrame: up to 1656 hours post treatment
measure: Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose
timeFrame: up to 1656 hours post treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 1293.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Albach FN, Wagner F, Huser A, Igel J, Joseph D, Hilbert J, Schoelch C, Padula SJ, Steffgen J. Safety, pharmacokinetics and pharmacodynamics of single rising doses of BI 655064, an antagonistic anti-CD40 antibody in healthy subjects: a potential novel treatment for autoimmune diseases. Eur J Clin Pharmacol. 2018 Feb;74(2):161-169. doi: 10.1007/s00228-017-2362-8. Epub 2017 Nov 10.
Clinical trial NCT05100082: Survey of Cabozantinib Tablets Used To Treat People With Hepatocellular Carcinoma
Official title: Special Drug Use Surveillance for Cabometyx Tablets "Hepatocellular Carcinoma"
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatocellular Cancer
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 263
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with unrespectable hepatocellular carcinoma that has progressed after cancer chemotherapy in part of routine medical care.

Brief summary: This study is a survey in Japan of Cabozantinib tablets used to treat Japanese people with a type of liver cancer called hepatocellular carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with hepatocellular carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 12 months.


Eligibility criteria: Inclusion Criteria:

Participants with unresectable hepatocellular carcinoma that has progressed after cancer chemotherapy (Regardless of previous treatment history)

Exclusion Criteria:

Participants who has a history of hypersensitivity to any component of cabozantinib.

Primary outcomes:
measure: Number of Participants with Adverse Events Related to Hepatic Failure, Hepatic Dysfunction, and Pancreatitis
timeFrame: Up to 12 months
measure: Number of Participants with Serious Adverse Events
timeFrame: Up to 12 months
measure: Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Cabozantinib Tablets
timeFrame: Up to 12 months
measure: Number of Participants with Grade 3 or higher Adverse Events
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
timeFrame: Up to 12 months
measure: Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)
timeFrame: Up to 12 months
measure: Disease Control Rate (DCR)
timeFrame: Up to 12 months
measure: Overall Survival (OS)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04932382: Misoprostol Prior to Intrauterine Device Insertion
Official title: Misoprostol Prior to Intrauterine Device Insertion in Non-menstruating Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The intrauterine device (IUD) is a reliable, safe, long acting, and effective contraceptive method . In spite of that, the pain associated with IUD insertion can be a cause against its insertion. Many researches have been conducted aiming to decrease the degree of pain during IUD insertion; these studies included medical and also technical methods.

The physicians usually prefer to insert the IUD during women's menses because the women are very unlikely to be pregnant and the insertion is easier and the pain is lower The easiness of IUD insertion is a very important issue that can increase women's satisfaction and decrease insertion pain.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-45 years
* Non-pregnant women
* Women who will come when there are non-menstruating.

Exclusion Criteria:

* Women received any analgesics or misoprostol in the 24 hours prior to insertion
* Women with any contraindications for IUD insertion
* Nulliparous women
* Women refuse to participate.
* Women have any contraindication of misoprostol.

Primary outcomes:
measure: The degree of pain perception during IUD insertion assessed by visual analogue scale
timeFrame: 5 minutes
Secondary outcomes:
measure: The ease of IUD insertion: will be measured by visual analogue like scale [from 0 to 10]
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT05257382: Added Value of Cone Beam CT Guidance to Electromagnetic Navigation Bronchoscopy for the Diagnosis of Pulmonary Nodule.
Official title: A Randomized Controlled Study Evaluating the Added Value of an Hybrid Room Equipped With a Cone Beam CT (CBCT) to Electromagnetic Navigation Bronchoscopy (ENB) for the Diagnosis of Pulmonary Nodule.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Pulmonary Disease
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2022-02-25
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: A monocentric prospective and randomized trial aiming to compare the diagnostic yield and safety of electromagnetical-guided bronchoscopy (ENB) procedures coupled to trans-bronchial lung cryobiopsies for the diagnosis of pulmonary nodule when performed either in a "standard" bronchoscopy suite or in a hybrid room with CBCT guidance and the use of the CrossCountry technique as required.


Eligibility criteria: Inclusion Criteria:

* Pulmonary nodule of maximum 30mm of largest diameter
* Nodules can be either solid or subsolid (including GGO) without evidence of loco-regional or distant metastasis that could be biopsied, and no evidence for an infectious underlying disease.
* A multidisciplinary discussion is performed for each case before considering its inclusion in the study in order to validate the indication of ENB-guided biopsy. Of note, any other endoscopic or trans-thoracic procedure should be tried before considering ENB if it could achieve the diagnosis according to the investigator's judgment.

Exclusion Criteria:

* Patient eligible for a direct surgical resection of the nodule
* Other exclusion criteria are a higher risk of bleeding (platelets count lower than 80,000/mm³, a systolic pulmonary arterial pressure (sPAP) higher than 45 mmHg at transthoracic ultrasonography, prothrombin time international normalized ratio - INR \>1.5, activated partial thromboplastin time - APTT \>35, uninterrupted anti-coagulant/anti-aggregant therapy), and the presence of any contraindication to general anesthesia as determined by the principal investigator (significant cardiac comorbidities, hypercapnia, severe hypoxia...).

No strict limits for inclusion were applied regarding diffusing capacity for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in 1 second (FEV1).

Primary outcomes:
measure: Diagnostic yield
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Rate of pneumothorax
timeFrame: up to 1 month after the procedure
measure: Rate of bleeding
timeFrame: up to 1 month after the procedure
measure: Duration of the interventions
timeFrame: Up to one day after the procedure
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hopital Erasme
Study officials:
affiliation: Erasme University Hospital
name: Benjamin Bondue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00228982: Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
Official title: A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Diseases, Infectious
Skin Diseases, Bacterial
Staphylococcal Skin Infections
Keywords: Complicated Skin Infections
Infectious Skin Diseases
Bacterial Skin Diseases
Staphylococcal Skin Infections
Cephalosporin
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 784
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: The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections.

Detailed description: Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of an infection consistent with complicated skin and skin structure infections.

Exclusion Criteria:

* Known or suspected hypersensitivity to any study medication
* Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
* Previous enrollment in this study
* Treatment with any investigational drug within 30 days before enrollment.

Primary outcomes:
measure: Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.
timeFrame: 7 weeks
Secondary outcomes:
measure: Microbiological outcome at 7-14 days after the end of therapy. Clinical and microbiological outcome at late follow-up visit. Evolution of signs and symptoms of disease. Time to clinical cure. Safety and tolerability evaluations during the study.
timeFrame: 7 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: