louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01965587: RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia
Official title: RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia. A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menorrhagia
Keywords: novasure
Mirena IUS
menorrhagia
pelvic pain
ashermanns
Lead sponsor: Walsall Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure alone in the treatment of menorrhagia

Detailed description: Endometrial ablation is a commonly used treatment option for women with heavy periods. It is recommended as an initial treatment. It aims at destroying the lining of the womb to reduce heavy menstrual loss.

A hormone releasing device in the womb (MIRENA®)is another commonly used treatment for women with heavy menstrual bleeding and has added benefit of reducing cyclical pain.

There is an increase in the number of women presenting to gynaecology clinic with persistence of pain or cyclical pain with absent or light bleeding after second generation endometrial ablation (Novasure). This may be due to the pockets of active lining of the womb that remains after ablation or possible adhesions created by the treatment. Most women require surgical removal of the womb (hysterectomy) because of pain or a further surgical procedure to divide these adhesions in an attempt to relieve pain and drain any collections in the womb.

We aim to determine if the combined use of MIRENA® and NOVASURE® (which is the second generation endometrial ablation technique used in our unit) will help in reducing the number of women presenting with cyclical pain and requiring further intervention or surgery. The aim of the current study is to compare between women receiving only NOVASURE treatment and women receiving combined NOVASURE and MIRENA treatment for heavy menstrual bleeding. The primary and secondary outcomes will be assessed at 6 and 12 months by a patient questionnaire. The primary outcome is improvement in quality of life The secondary outcomes include

* Lowering of surgical intervention
* Reduction in pain
* Reduction in amount of bleeding This will be a pilot study to determine if the theory is correct and then a larger powered study can be undertaken

Eligibility criteria: Inclusion Criteria:

* Anybody suitable for novasure ablation

Exclusion Criteria:

* Mirena IUS is indicated as treatment

Primary outcomes:
measure: Quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
state: West Midlands
Study officials:
References:
Clinical trial NCT03442387: Framing of Numerical Information in Cochrane Summaries
Official title: Framing of Numerical Information in Cochrane Summaries: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study was to conduct three different parallel randomized controlled trials to assess how the different framing of Cochrane summary information (positive vs negative framing of health information) affects affect the perception of the efficacy and intention for use of the described treatment.

Detailed description: The aim of the study was to conduct three different parallel randomized controlled trials to assess how the different framing of Cochrane summary information (positive vs negative framing of health information) affects affect the perception of the efficacy and intention for use of the described treatment.

Eligibility criteria: Inclusion Criteria:

* First year medical students

Exclusion Criteria:

* Those who have failed first year and have to repeat it.

Primary outcomes:
measure: Perception of effectiveness
timeFrame: Immediately after reading
Secondary outcomes:
measure: Desire to use the described treatment
timeFrame: Immediately after reading
measure: Desire that treatment is prescribed by family doctor
timeFrame: Immediately after reading
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
affiliation: University of Split, School of Medicine
name: Ivan Buljan, MPsy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buljan I, Tokalic R, Roguljic M, Zakarija-Grkovic I, Vrdoljak D, Milic P, Puljak L, Marusic A. Framing the numerical findings of Cochrane plain language summaries: two randomized controlled trials. BMC Med Res Methodol. 2020 May 6;20(1):101. doi: 10.1186/s12874-020-00990-4.
Clinical trial NCT02510287: A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: analgesia, epidural
labor pain
patient satisfaction
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. Currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as compared with the continuous infusion strategy. In this study, the investigators seek to compare both strategies in 132 laboring women.


Eligibility criteria: Inclusion Criteria:

* At term pregnancy
* Laboring patients requiring epidural analgesia

Exclusion Criteria:

* American Society of Anesthesiologists physical status \> or equal than 3
* allergy to local anesthesics
* Neuraxial contraindications
* Hemodynamic instability
* Systemic disease such as diabetes mellitus or hypertension
* Chronic usage of analgesics
* Disease associated to pregnancy such as gestational diabetes, preeclampsia, fetal malformations among others

Primary outcomes:
measure: Pain level in laboring women measured by the Numeric Analog Scale
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario Fundación Santa Fe
Study officials:
References:
Clinical trial NCT00080054: A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
Official title: Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioma
Glioblastoma
Astrocytoma
Oligodendroglioma
Brain Neoplasm
Keywords: Malignant Glioma
Glioblastoma multiforme
GBM
Anaplastic astrocytoma
AA
Anaplastic oligodendroglioma
Anaplastic mixed glioma
Brain tumor
Brain neoplasm
Glioma
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
First posted: 2004-03-23
Enrollment: 24
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: The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma)
* ECOG performance status score of 0, 1, or 2
* Each patient must sign a study-specific informed consent form

Exclusion Criteria:

Laboratory values of:

* Absolute neutrophil count \< 2000/µL
* Platelet count \< 100,000/µL
* AST or ALT \> 2 x the upper limit of normal (ULN)
* Alkaline phosphatase \> 5 x ULN
* Bilirubin \> 2 x ULN
* Creatinine \> 2.0 mg/µL

and

* Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period
* Women who are pregnant or lactating

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
Study officials:
References:
Clinical trial NCT06208254: Prevalence and Risk Indicators of Peri-implant Diseases in China
Official title: Prevalence and Risk Indicators of Peri-implant Diseases in China: A Multicenter Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peri-Implantitis
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
Collaborators: name: Dalian Medical University
name: Nanchang University
name: Ningxia Medical University
name: Shanxi Medical University
name: Hospital of Stomatology, Wuhan University
name: Hospital of Stomatology, Sun Yat-Sen University
name: Zunyi Medical College
name: Hong Kong Brånemark Osseointegration Center
First posted: 2024-01-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who have conventional dental implants placed and over 5 years of functional loading.

Brief summary: The goal of this multicenter cross-sectional study is to investigate the prevalence of peri-implantitis in China. The main questions it aims to answer are:

* What is the prevalence of peri-implantitis in China
* What are the risk indicators of peri-implantitis in China

Participants will be invited to a free-of-charge clinical and radiographic examination of conventional dental implants present for over 5 years.


Eligibility criteria: Inclusion Criteria:

1. Patients having at least one rough surface titanium implant in function for more than 5 years
2. Patients treated between January 1, 2013 and December 31, 2017
3. All the implants osseointegrated in the patients' mouth at the time of the examination (including those placed in external clinics) and having at least 5 years of loading, either proven by dental charts or confirmed by the patients, were evaluated

Exclusion Criteria:

1. Selected patients were invited to participate in the study by telephone calls on the numbers reported in their medical records, and if no response, the patient was not discarded until at least five attempts on different days have been made
2. Periapical and/or panoramic radiographs unavailable
3. History of peri-implantitis and/or peri-implant mucositis treatment
4. Refusal to participate in the study

Primary outcomes:
measure: Bleeding on probing [positive (+) or negative (-)]
timeFrame: About 5-10 years after surgery
measure: Peri-implant probing depth (mm)
timeFrame: About 5-10 years after surgery
measure: Bone loss (mm)
timeFrame: About 5-10 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Yiqun Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05191654: Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD
Official title: Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in Children With Down Syndrome With and Without Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Defects
Down Syndrome
Gross Motor Development Delay
Keywords: congenital heart defects
Down syndrome
motor skills
Lead sponsor: Atılım University
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with down syndrome

Brief summary: Congenital heart diseases (CHD) are detected in 40-60% of individuals with Down syndrome (DS) and increase the risk of developmental delay in the presence of syndromes. The aim of the study was to compare cardiopulmonary parameters, gross motor development and hand grip strength in DS children with and without CHD. Demographic variables, cardiopulmonary parameters and echocardiographic values were recorded. Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Down syndrome as a result of genetic analysis,
* For the congenital heart disease group; undergoing cardiac surgery at least 6 months before the evaluation, diagnosed as CHD by a pediatric cardiologist based on echocardiographic findings,
* For the group without congenital heart disease, patients who have not undergone cardiac surgery, are asymptomatic with a septal defect smaller than 4-5 mm, are expected to close, and are hemodynamically normal by a pediatric cardiologist,
* Children whose families were informed about the study and gave written consent to participate in the study were included in the study.

Exclusion Criteria:

* Having another genetic abnormality other than Down syndrome,
* undergoing surgery other than cardiac surgery,
* Having an orthopedic or neurological problem,
* Respiratory support,
* With atlantoaxial instability,
* Children with hematological disease were not included in the study.

Primary outcomes:
measure: Gross Motor Function Measure-88
timeFrame: october 2020- june 2021
measure: Bulb Dynamometer
timeFrame: october 2020- june 2021
measure: Left ventricular ejection fraction (EF)
timeFrame: october 2020- june 2021
measure: Interventricular septum wall thickness (IVS)
timeFrame: october 2020- june 2021
measure: Left ventricular end-diastolic diameter (LVDd)
timeFrame: october 2020- june 2021
measure: Fractional shortening (FS)
timeFrame: october 2020- june 2021
measure: Wang Respiratory Score
timeFrame: october 2020- june 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Atılım University
Study officials:
References:
Clinical trial NCT02296554: Superior Labral Tear From Anterior to Posterior (SLAP) Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder
Official title: SLAP Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder: A Randomized Outcomes Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: SLAP Tear
Keywords: SLAP Repair
Biceps Tenodesis
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2014-11-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biceps Tenodesis is currently advocated for older, less active patients, but to date is not often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young, active patients. The ideal surgical management for this pathology is not clearly known. More surgeons are using biceps tenodesis as a treatment for SLAP tears, including in the young, active population. If this study were to demonstrate that biceps tenodesis is similar to or better than SLAP repair, this would fundamentally change the treatment of SLAP tears. Perhaps more importantly, it would likely mean a less involved rehabilitation and earlier return to activities for patients with this pathology.


Eligibility criteria: Inclusion Criteria:

- Primary isolated SLAP tear, confirmed on MRI

Exclusion Criteria:

* Concomitant procedure needed such as a labral repair, rotator cuff repair or distal clavicle excision.
* Revision Surgery
* Previous shoulder surgery
* Major medical illness
* Inability to speak or read English

Primary outcomes:
measure: Patient reported function and pain
timeFrame: Baseline
measure: Patient reported function and pain
timeFrame: 6 months
measure: Patient reported function and pain
timeFrame: 1 year
measure: Patient reported function and pain
timeFrame: 2 years
measure: Patient reported function and pain
timeFrame: 5 years
Secondary outcomes:
measure: Range of Motion & Strength
timeFrame: Baseline
measure: Range of Motion
timeFrame: 3 months
measure: Range of Motion & Strength
timeFrame: 6 months
measure: Range of Motion & Strength
timeFrame: 1 year
measure: Range of Motion & Strength
timeFrame: 2 years
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
Study officials:
References:
Clinical trial NCT04441554: High-resolution 7 Tesla MRI of C-spine - Comparison with 3 Tesla MRI
Official title: High-resolution MRI (7 Tesla) of Foraminal Stenosis and Differentiation of the Degenerated Discovertebral Unit - Comparison with 3 Tesla MRI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Magnetic Resonance Imaging
Cervical Spine Disease
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone a MRI of the spine for clinical indications will be enrolled through consecutive ongoing recruitment in daily clinical practice at Balgrist University Hospital Zurich.

Brief summary: High-resolution MRI (7 Tesla) of the cervical spine is capable to differentiate osseous spurs from discus-material and better depict the compressed nerve in the neuroforamen compared to 3T MRI.

Provide the surgeon with a detailed high-resolution anatomical image before surgery and potential no need for CT (if the bony anatomy is of crucial importance).


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* \>18 years old
* Patients with cervical back pain (radiculopathy) and scheduled surgery for foraminal stenosis or central stenosis or cervical periradicular injection therapy (PRT)

Exclusion Criteria:

* previous surgery
* tumor patients
* pregnancy or breast feeding
* any MRI contra-indications

Primary outcomes:
measure: differentiation of compressed nerves in neuroforamen (7T vs 3T)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
References:
Clinical trial NCT03769454: A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers
Official title: A Phase I Safety and Tolerability Study of PP-001 Eye Drops in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Keratoconjunctivitis
Ocular Surface Disease
Lead sponsor: Panoptes Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, PP-001 eye drops are assessed for safety and tolerability in healthy, adult volunteers. PP-001 is a novel, anti-inflammatory small molecule that inhibits a specific enzyme (Dihydroorotate Dehydrogenase).

The study was amended and now includes patients with ocular surface inflammation.

Detailed description: In this prospective, single-centre, double blind (within each cohort), placebo controlled, randomised study, safety and tolerability of PP-001 eye drops is assessed in healthy, adult volunteers (cohorts 1-3) and in patients with ocular surface inflammation (cohort 4). PP-001 is a novel small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) with anti-inflammatory properties.

Eligibility criteria: Inclusion Criteria (excerpt):

Cohorts 1-3:

* male or female healthy volunteers 18 - 64 years of age
* good general state of health and participants must not have a diagnosis of any eye disease that could effect the pharmacokinetics of PP-001

Cohort 4:

* male or female subjects 18-64 years of age with ocular surface inflammation in both eyes
* ocular surface inflammation as defined per protocol
* good general state of health

Exclusion Criteria (excerpt):

Cohorts 1-4:

* participation in other clinical trials within 30 days prior to dosing start (ocular and non-ocular clinical trials)
* pregnant or nursing patients
* regular use of any ocular agents within 60 days prior to start dosing

Primary outcomes:
measure: Evaluation of safety and tolerability by determining treatment emergent adverse events
timeFrame: 28 days (cohorts 1-3) and 20 days (cohort 4)
Secondary outcomes:
measure: Evaluation of Peak Plasma Concentration (Cmax) in peripheral blood
timeFrame: 1 and 12 days (cohorts 1-3)
measure: Evaluation of area under the plasma concentration versus time curve (AUC) in peripheral blood
timeFrame: 1 and 12 days (cohorts 1-3)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Hospital Vienna
Study officials:
References: