louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05272345: Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy
Official title: Follow-Up Wıth Dıagnosıs Of Fıbromyalgıa In Patıents Wıth Sexual Functıonal Dısorder Evaluatıon Of Sexual Therapy And Post-Therapy Fıbromyalgıa
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Sexual Dysfunction
Keywords: Fibromyalgia
Patients
Quality of Life
Sexual desire
FSFI scala
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: investigators aim to re-evaluate the findings of Fibromyalgia in patients whose FSFI scores return to normal levels after sexual therapy, by identifying patients with sexual dysfunction according to the FSFI scale applied in patients investigators followed up with a diagnosis of fibromyalgia, and when investigators consulted with obstetricians.

Detailed description: Apart from routine Fibromyalgia treatments, investigators think that Fibromyalgia patients should be evaluated in detail in terms of sexual dysfunction, and better results will be obtained by adding sexual therapy to the treatment in patients with FSFI score below 26.55.

In the current literature review, investigators have seen that there is no study on the evaluation of fibromyalgia before and after sexual therapy.

investigators think that our study will be a pioneer in terms of showing the importance of the multidisciplinary approach in the treatment of Fibromyalgia.

investigators foresee that sexuality is still a subject that is avoided to be talked about due to the cultural infrastructure of developing countries, and that Fibromyalgia will actually decrease with the regulation of sexual life.

investigators believe that more comprehensive studies with this perspective will develop a multidisciplinary approach in Fibromyalgia.

Eligibility criteria: Inclusion Criteria:

* Follow-up with a diagnosis of fibromyalgia
* Reproductive age (15-49 years)
* Women with sexual dysfunction (FSFI score \< 26.55)

Exclusion Criteria:

* Women Wıth Ibromyalgıa Wıthout Sexual Dysfunction
* Women Wıth A Score Greater 26.55 Wıthout Therapy

Primary outcomes:
measure: VAS evaluation results for pain before sexual therapy in patients with fibromyalgia
timeFrame: 6 months
measure: VAS evaluation results for pain after sexual therapy in patients with fibromyalgia
timeFrame: 6 months
measure: FSFI scores before sexual therapy in patients with fibromyalgia
timeFrame: 6 months
measure: FSFI scores after sexual therapy in patients with fibromyalgia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
city: Istanbul
country: Turkey
facility: Pınar Kadiroğulları
Study officials:
affiliation: Acıbadem University Atakent Hospital
name: Pınar Kadiroğulları
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780845: AKIN Criteria: Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft (CABG)
Official title: AKIN (Acute Kidney Injury Network): Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure
Keywords: Acute Kidney failure
Clinical outcomes
On-pump
Coronary artery bypass grafting
Morbidity
Mortality
Lead sponsor: Hospital de Base
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 817
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Groups AKI (-) and AKI (+) selected consecutively after admission in cardiac surgery postoperative care unit

Brief summary: The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG.

Detailed description: Eight hundred and seventeen patients was enrolled in this series and divided into to groups: Group AKI (-) - patients without acute kidney injury after on-pump CABG. Group AKI (+) - patients with acute kidney injury after on-pump CABG. AKI was defined as an absolute increase in serum creatinine (SCr) of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l) or a percentage increase in SCr of more than or equal to 50% (1.5-fold from baseline). The change in SCr concentration was defined as the difference between immediate postoperative concentration and the highest concentration during the stay in ICU. Clinical Outcomes and 30-day mortality was evaluate in this patients.

Eligibility criteria: Inclusion Criteria:

* Patients underwent on-pump coronary artery bypass grafting
* Patients with at least two serum creatinine values within 48 hours.

Exclusion Criteria:

* Patients with end-stage kidney disease requiring renal replacement therapy.

Primary outcomes:
measure: To test the hypothesis that patients with acute kidney injury after on-pump CABG have higher 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: To compare clinical outcomes in patients with and without acute kidney injury after on-pump CABG
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: São José do Rio Preto Medical School
name: Lilia N Maia, PhD
role: STUDY_DIRECTOR
References:
citation: Machado MN, Miranda RC, Takakura IT, Palmegiani E, Santos CA, Oliveira MA, Mouco OM, Hernandes ME, Lemos MA, Maia LN. Acute kidney injury after on-pump coronary artery bypass graft surgery. Arq Bras Cardiol. 2009 Sep;93(3):247-52. doi: 10.1590/s0066-782x2009000900008. English, Portuguese, Spanish.
Clinical trial NCT02905045: Efficacy of Ketoprofen Before Hysterosalpingography
Official title: Effect of Oral Ketoprofen on Hysterosalpingography Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Relief
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye


Eligibility criteria: Inclusion Criteria:

* any patient came for Hysterosalpingography

Exclusion Criteria:

* any patient has contraindication to Hysterosalpingography

Primary outcomes:
measure: Mean pain score during the procedure
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT02417545: Gaze and Stair Walking in Patients With Vestibular Dysfunction
Official title: Gaze and Movement Behavior of Patients With Vestibular Dysfunction During Level Floor, Ramp, and Stair Walking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vestibular Diseases
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study sample includs patients with vestibular disorder and age matched healthy participants. Patients with vestibular disorder will be diagnosed by a pathological horizontal head impulse test to both sides (\< 0.80), as assessed by using a video-based system and the presents of saccades.

Brief summary: The aim of this study is to assess the differences in gaze and gait during the stair and ramp negotiation (+transition to normal level walking) between healthy controls and vestibular patients (fallers and non-fallers).

Detailed description: For a better understanding of falls in patients with vestibular disorders it might be important to identify the challenging environmental that provoke functional deficits; e.g. stair or ramp negotiation. The three steps at the ground and at the top of stairs is the most common location for missteps and stair accidents. This is supported by the observation made in a 12-month prospective study were 32% of the falls happened during the last step going down stairs in vestibular patients.

It remains open if patient's vestibular dysfunctions have a different gaze or gait behavior than healthy individuals.

Eligibility criteria: Inclusion Criteria:

* All included patients are diagnosed with single or two-sided vestibular dysfunction.
* Adult male and female participant's (≥18 years)
* Signed informed consent after being informed

Exclusion Criteria:

* Benign paroxysmal positional vertigo
* Acute pain
* Walking disability (independent walking distance \<10 meters)
* Uncontrolled cardiovascular disease (e.g.: uncontrolled blood pressure)
* Gait problems caused by Hip or knee endoprothesis
* Weakness due to neurological problems
* Known or suspected non-compliance
* Contraindications on ethical grounds

Primary outcomes:
measure: Gaze
timeFrame: 30 minutes
Secondary outcomes:
measure: Gait
timeFrame: 30 minutes
measure: Fall Calendar
timeFrame: one year
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
state: ZH
Study officials:
affiliation: University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
name: Jaap Swanenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03521245: Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
Official title: Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HER2-positive Breast Cancer
Keywords: breast cancer
epidermal growth factor receptor
HER2
EGFR
biomarkers
targeted therapy
NGS
RNAseq
mRNA
transcriptome analysis
signaling pathway
intracellular molecular pathway
Oncobox
trastuzumab
Lead sponsor: OmicsWay Corp.
Sponsor class: INDUSTRY
Collaborators: name: Oncobox Ltd., Russia
name: Vitamed LLC, Russia
name: Republican Oncological Dispensary of Karelia Republic, Russia
First posted: 2018-05-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of North-Western and Central Parts of Russian Federation

Brief summary: The purpose of the study is to identify molecular markers at the level of molecular pathway activation to predict efficacy of anti-HER2 therapy with Trastuzumab.

Detailed description: Biopsy and/or surgical samples from Her2-positive breast cancer patients treated with Trastuzumab alone or in combinations with other regimens of chemotherapy with known clinical outcomes will be collected and subjected to mRNA sequencing. Expression profiles will be analysed using original bioinformatic platform Oncobox. Based on comparison of molecular pathways activation strength and clinical response to Trastuzumab and chemotherapy, this study aims to identify molecular markers predicting efficacy of therapy with Trastuzumab and the possibility of further relapse.

Eligibility criteria: Inclusion Criteria:

* adult females
* histologically confirmed HER2-positive breast cancer
* available FFPE samples of breast cancer tissue
* patients treated with Trastuzumab alone or in combination(s) with other regimens of chemotherapy with known outcome according to RECIST 1.1
* stage II or more
* patients who have signed an informed consent

Exclusion Criteria:

* less than 70% of intact tumor cells in available FFPE samples

Primary outcomes:
measure: Tumor response by RECIST v1.1 or pathological response according to Chevallier system
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Walnut
country: United States
facility: OmicsWay Corp.
state: California
city: Petrozavodsk
country: Russian Federation
facility: Republican Oncological Dispensary of the Ministry of Healthcare of Karelia Republic
state: Karelia Republic
city: Moscow
country: Russian Federation
facility: Vitamed LLC
city: Moscow
country: Russian Federation
facility: "Oncobox" Ltd.
Study officials:
References:
Clinical trial NCT01215045: Visual Performance of Bilateral AcrySof ReSTOR Aspheric +4
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: AcrySof ReSTOR Aspheric +4
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants taken from physician's patient pool implanted with the AcrySof ReSTOR +4 Intraocular Lens (IOL)

Brief summary: Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain spectacle freedom.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cataracts

Exclusion Criteria:

* Preexisting conditions confounding results; \> 1 Diopter preoperative astigmatism

Primary outcomes:
measure: Visual Acuity
timeFrame: 6 months
Secondary outcomes:
measure: Contrast sensitivity, patient survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT03131245: Optic Nerve Sheath Diameter in Craniosynostosis
Official title: Changes of Optic Nerve Sheath Diameter in Modified Prone Position in Craniosynostosis Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Nerve Sheath Diameter
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 30
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children for correction of craniosyostosis

Brief summary: Changes of optic nerve sheath diameter after position changes

Detailed description: Changes of optic nerve sheath diameter after position changes from supine to prone position in children for craniosynostosis

Eligibility criteria: Inclusion Criteria:

* craniosynostosis

Exclusion Criteria:

* infection on eye area

Primary outcomes:
measure: optic nerve sheath diameter
timeFrame: 10 minutes after prone position
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
References:
Clinical trial NCT01043445: -Oleoyl Glycerol is a GPR119 Agonist and Signals GLP-1 Release in Humans.
Official title: G Protein-coupled Receptor in the Intestine (GPR 119) Stimulated GLP-1 Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: GPR 119
GLP-1 secretion
2-oleoyl-glycerol
Dietary supplementation
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2010-01-06
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the impact of different ligands of GPR 119 (a G protein-coupled receptor in the intestine) on the secretion of the incretin hormones, GLP-1 and GIP.

Detailed description: We have found a new ligand for the GPR 119 receptor. This study evaluate the impact of this ligand on the incretion hormone responses, beta cell function and gall bladder function in healthy young men.

Eligibility criteria: Inclusion Criteria:

* Healthy caucasians v- Normal OGTT (75 g of glucose) according to WHO's criteria
* Normal hemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease (ALAT\> 2x normal level)
* Nephropathy (s-creatinin \>130 microM or albuminuria)
* Relatives with type 2 diabetes

Primary outcomes:
measure: The effect of this newly discovered GPR 119 agonist on gut hormone responses, in particular GLP-1 in response of the different meals administered to the subjects
timeFrame: 1 year
Secondary outcomes:
measure: Glucose homeostasis, gall bladder contraction in response of the different meals administered to the subjects
timeFrame: 1 year
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Clinical Physiology, Glostrup Hospital
Study officials:
affiliation: Glostrup Hospital, University of Copenhagen
name: Katrine B Hansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentofte Hospital
name: Filip K Knop, MD, Ph.d
role: STUDY_DIRECTOR
affiliation: Farmaceutical Faculty, University of Copenhagen
name: Harald S Hansen, professor
role: STUDY_DIRECTOR
affiliation: Biomedical Science, University of Copenhagen
name: Jens J Holst, MD;DMSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01473745: The Nasal Changes Affected by Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy
Official title: The Nasal Changes Affected by 2 Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy--A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Conditions in T74.31 or T76.31
Keywords: Alar Base Suture; Nasolabial Change; 3D stereogrammetry
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: study hypothesis

1. The aim of this study:

   How can the investigators predict and control the nasal changes after maxillary LeFort I osteotomy with 2 different alar base suture techniques ?
2. Study hypothesis

   * Null hypothesis: Nasal changes were not affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
   * Alternative : Nasal changes were affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy

Detailed description: Background and study purpose:

Patients who received maxillary LeFort I osteotomy often complained about their nose become wider and more nostril show after surgery. According the the literature review, the conventional and modified alar base cinch technique both could control the interalar width. However, there is no long term result show which technique is superior to the other. Therefore, in order to improve patients' nasal and midfacial esthetics after the surgery, this study is to evaluate how the nasal changes affected by 2 different alar base cinch suture and which technique could result in a more positive effect.

Eligibility criteria: Inclusion Criteria:

* Taiwanese patients who received LeFort I osteotomy at CGMH during 2011-2012
* No previous craniofacial surgery
* Patients agreed to attend this study and willing to sign the agreement
* Patients who are elder than 18 years old and after growth completion

Exclusion Criteria:

* Craniofacial anomalies
* cleft lip and /or palate patients
* patients without all the documents
* patients do not receive combined correcting nasolabial shape and orthognathic surgery.

Primary outcomes:
measure: Soft and Hard Tissue Landmarks Movement
timeFrame: The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.
Secondary outcomes:
measure: 14 Nasolabial Linear Parameters
timeFrame: up to post-operation 6 months
measure: 1 Nasolabial Angular Parameters
timeFrame: up to post-operation 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung memorial hospital
Study officials:
affiliation: Chang Gung MH
name: Ellen, Wen Ching Ko, DDS,MS
role: STUDY_DIRECTOR
affiliation: Chang Gung MH
name: YiHsuan Chen, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04907045: An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care
Official title: Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use Disorders
Illicit Drug Use
Alcohol-Related Disorders
Keywords: Implementation Science
Mobile Applications
Drug Use Disorders
Quality Improvement
Primary Health Care
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-05-28
Enrollment: 1552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized parallel groups pilot study to evaluate intervention delivery, data collection, and analysis procedures. Two primary care clinics will implement the reSET and reSET-O digital therapeutics for substance use disorders. There will be one clinic per arm in this pilot study. Implementation strategies will be varied across arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.


Eligibility criteria: Inclusion Criteria:

* Had a primary care visit in a participating clinic during the pilot
* Screened positive for substance use
* Adult aged 18 years or older at time of visit

Exclusion Criteria:

* None

Primary outcomes:
measure: Reach of the digital therapeutic to patients in the primary care clinic
timeFrame: 6 months
measure: Fidelity of patients use of the digital therapeutic to clinical recommendations
timeFrame: 9 months
Secondary outcomes:
measure: Effectiveness
timeFrame: 9 months
Other outcomes:
measure: Reach-2
timeFrame: 6 months
measure: Reach-3
timeFrame: 6 months
measure: Fidelity-2
timeFrame: 9 months
measure: Fidelity-3
timeFrame: 9 months
measure: Adoption
timeFrame: 6 months
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Joseph E Glass, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: