louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02960828: "Stop Early Age-related Macular Degeneration (AMD) From Vision Loss Eternally" Study
Official title: Focal Subthreshold Laser Treatment for Macular Drusen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-Related Macular Degeneration
Retinal Drusen
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2016-11-10
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to validate the efficacy and safety of subthreshold laser photocoagulation on high-risk macular drusen in early age-related macular degeneration which has a high risk of conversion to exudative AMD.

Detailed description: SAVE Study (Stop Early Age-related Macular Degeneration form Vision Loss Eternally)

Eligibility criteria: Inclusion Criteria:

* Drusen in both eyes examined under fundoscopy
* At least one of the eyes must have high-risk soft drusen
* BCVA below ETDRS 83 letters
* Patient with consent to participate

Exclusion Criteria:

* Prior diagnosis with choroidal neovascularization
* Exudative AMD in at least one eye
* If the patient has only one visually effective eye (last eye)
* Other macula or retinal diseases than age-related macular degeneration

Primary outcomes:
measure: Change in drusen size
timeFrame: 3 month interval
Secondary outcomes:
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: 3 months interval
measure: Change in drusen distribution
timeFrame: 3 month interval
measure: Change in autofluorescence
timeFrame: 3 month interval
measure: Choroidal Neovascularization
timeFrame: 3 months interval
measure: Contrast Sensitivity
timeFrame: 3 months interval
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyu Hyung Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03726528: Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops
Official title: Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Takotsubo Syndrome
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aim of this prospective study is to assess the pathophysiology of Takotsubo Syndrome by obtaining pressure volume loops with conductance catheters, which allows detailed conclusions regarding systolic and diastolic hemondynamics and subsequently regarding potential underlying mechanisms


Eligibility criteria: Inclusion Criteria:

* Confirmed Takotsubo syndrome according to current diagnostic criteria including complete normalization of left ventricular function during follow-up
* Sinus rhythm during invasive measurements
* Age ≥18 years
* Written informed consent

Exclusion Criteria:

* Cardiogenic shock
* Signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging
* Pregnancy
* Participation in another trial

Primary outcomes:
measure: Changes in contractility derived from pressure-volume measurements
timeFrame: Day 0
measure: Changes in contractility derived from pressure-volume measurements
timeFrame: Day 0
measure: Changes in contractility derived from pressure-volume measurements
timeFrame: Day 0
measure: Changes in contractility derived from pressure-volume measurements
timeFrame: Day 0
measure: Changes in contractility derived from pressure-volume measurements
timeFrame: Day 0
measure: Changes in contractility derived from pressure-volume measurements
timeFrame: Day 0
measure: Changes in contractility derived from pressure-volume measurements
timeFrame: Day 0
Secondary outcomes:
measure: Energetic parameters derived from pressure-volume measurements
timeFrame: Day 0
measure: Energetic parameters derived from pressure-volume measurements
timeFrame: Day 0
measure: Afterload parameters derived from pressure-volume measurements
timeFrame: Day 0
measure: Afterload parameters derived from pressure-volume measurements
timeFrame: Day 0
measure: Afterload parameters derived from pressure-volume measurements
timeFrame: Day 0
measure: - Correlation of pressure-volume measurements with morphological and functional findings in CMR imaging
timeFrame: Day 3
measure: - Correlation of pressure-volume measurements with biomarker release
timeFrame: Day 0
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Medical clinic II-UKSH
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT03042728: Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
Official title: Impact of Inclusion of a Dog as Part of the Fibromyalgia Treatment Program on Patient's Physical and Mental Health Functioning - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study the investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical therapy for patients suffering from fibromyalgia currently enrolled in the Mayo Clinic Fibromyalgia Program.

Detailed description: The human animal bond refers an emotional relationship between animals and people. The purpose of this study is to evaluate whether the presence of a dog provide additional benefits above typical therapy for patients suffering from fibromyalgia and also to assess the emotional wellbeing state of the therapy dog.

Eligibility criteria: Inclusion criteria:

* Patients diagnosed with Fibromyalgia at our Fibromyalgia Clinic
* Patients actively being seen at the Fibromyalgia Clinic
* Able and willing to give informed consent
* Able to speak English
* Able to complete questionnaires
* No fear or allergy of dogs

Exclusion Criteria

* Diagnoses of bipolar disorder, schizophrenia, or dementia
* Individuals who decline to participate in the study
* Individuals that are severely allergic to or fearful of dogs

Primary outcomes:
measure: Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score
timeFrame: Baseline to 1.5 day
Secondary outcomes:
measure: Change in Pain Intensity Score (Numeric Rating Scale (NRS))
timeFrame: Baseline to 1.5 day
measure: Change in Score for Fatigue, Anxiety, and Depression
timeFrame: Baseline to 1.5 day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Arya B Mohabbat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005428: Familial Aggregation of Stress Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To perform data analyses on the familial aggregation of the stress response as it relates to hypertension.

Detailed description: BACKGROUND:

Given recent advances in the analyses of genetic epidemiologic data, the database presented a unique opportunity to address timely issues pertinent to the contribution of genetic and environmental factors to individual differences in cardiovascular reactivity.

DESIGN NARRATIVE:

Secondary data analyses were performed on family data obtained in an ongoing hypertension genetic study conducted at the University of Utah with Roger R. Williams as principal investigator. The available data represented one of the largest studies of cardiovascular reactivity among genetically related individuals. During 1981-83, a total of 2,548 subjects, members of 98 extended families (multiple generations and multiple nuclear families) participated in an extensive cardiovascular examination and were assessed on a comprehensive battery of cardiovascular tests. Annual follow-up questionnaires obtained information about the onset of hypertension and new medication prescribed. In 1991-92, a follow-up exam was conducted on 1,500 subjects.

The data analysis attempted to confirm or refute hypotheses postulating a reactivity-hypertension association; investigated whether there was a sex limitation in the genetic and environmental determinants of reactivity; explored genotype-by-age interactions in the control of reactivity;and determined whether there was shared genetic and/or environmental variance between reactivity and other recognized cardiovascular risk factors such as obesity or lipids.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cheng LS, Carmelli D, Hunt SC, Williams RR. Segregation analysis of cardiovascular reactivity to laboratory stressors. Genet Epidemiol. 1997;14(1):35-49. doi: 10.1002/(SICI)1098-2272(1997)14:13.0.CO;2-4.
citation: Cheng LS, Carmelli D, Hunt SC, Williams RR. Evidence for a major gene influencing 7-year increases in diastolic blood pressure with age. Am J Hum Genet. 1995 Nov;57(5):1169-77.
Clinical trial NCT04500028: Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System
Official title: Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IUCD Complication
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized controlled trial
Primary purpose: PREVENTION

Brief summary: To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.

Detailed description: Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant women
* Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
* Women who delivered only by cesarean section

Exclusion Criteria:

* Women with any uterine abnormalities such as congenital anomalies, endometrial lesions, adenomyosis, or fibroids.
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to isonicotinic acid hydrazide
* known psychiatric disorders ( anxiety and depression) and chronic use of medications that could interfere with pain perception (antidepressants and anticonvulsants)
* Women refuse to participate in the study

Primary outcomes:
measure: The difference in pain scores during intrauterine device insertion
timeFrame: 10 minutes
Secondary outcomes:
measure: duration of IUD insertion
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT03322228: Music Therapy Intervention to Reduce Caregiver Distress at the End of Life
Official title: Music Therapy Intervention to Reduce Caregiver Distress at the End of Life: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Stress
Anxiety
Depression
Keywords: Hospice
Palliative Care
Integrative Medicine
Music Therapy
Inpatient
Caregiver
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study plans to enroll 20 subjects. All subjects will receive 1 music therapy intervention lasting approximately 1 hour.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a study to assess the feasibility and acceptability of implementing a music therapy intervention for caregivers of hospitalized patients who are referred to inpatient hospice.

Detailed description: Caregivers are at high risk for stress, poor quality of life (QOL), and burnout. As a patient nears death, common themes for caregivers include anxiety and emotional distress from impending death, anticipatory grief, and acceptance of loss, which negatively impact the caregiver QOL. Investigators propose to conduct a pilot project to investigate music therapy impact on caregiver distress for caregivers of imminently dying hospitalized patients referred to hospice. Upon enrollment, caregivers will be provided a music therapy intervention with legacy-building components, and will be asked to complete 3 brief questionnaires on distress and quality of life before and after the music therapy to assess their response to the intervention. The overall aim is to reduce caregiver distress and optimize QOL.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Self-identified caregiver
3. English-speaking

Exclusion Criteria:

1. Unable to provide consent

Primary outcomes:
measure: Pearlin role overload measure (ROM)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Linear Analogue Self-Assessment (LASA)
timeFrame: Baseline to 6 months
measure: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
timeFrame: Baseline to 6 months
measure: Music Therapy Program Survey
timeFrame: Up to 72 hours after intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Maria Lapid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01298128: NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment
Official title: A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
In-vitro Fertilization
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to COH for IVF.


Eligibility criteria: Inclusion Criteria:

* Patients less than 38 years of age.
* Healthy women starting their first IVF/ICSI cycle.
* No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1
* Consent to randomization.

Exclusion Criteria:

* Any contraindication to COC use.
* Hypersensitivity to Nuva ring or any of its components.
* Language barrier to consent.

Primary outcomes:
measure: Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)
timeFrame: patients were followed for the duration of an in-vitro fertilization cycle- 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mount Sinai Hospital, Toronto ON
name: Kimberly E Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu KE, Alhajri M, Greenblatt E. A randomized controlled trial of NuvaRing versus combined oral contraceptive pills for pretreatment in in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):605-8. doi: 10.1016/j.fertnstert.2011.06.073.
Clinical trial NCT01242228: A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients
Official title: Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With a Dipeptidyl Peptidase-4 Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With a Dipeptidyl Peptidase-4 Inhibitor Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Dipeptidyl peptidase-4 inhibitor
ASP1941
DPP-4 inhibitor
long-term safety
Diabetes mellitus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.

Detailed description: This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on a DPP-4 inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients receiving with DPP-4 inhibitor mono-therapy for at least 4 weeks
* HbA1c value between 6.5 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: baseline and 52 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose
timeFrame: baseline and 52 weeks
measure: Change from baseline in fasting serum insulin
timeFrame: baseline and 52 weeks
measure: Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
timeFrame: for 52 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04332328: Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt
Official title: Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diet in Ulcerative Colitis Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ulcerative colitis with no other comorbidities

Brief summary: Diet is known to play role in the complex etiology of UC.Patient with UC tend to adapt unguided dietary habits without the guidance of a dietician or physician (Dejong,M.J 2019).so identification of nutritional gaps is needed to facilitate the development of evidence-based dietary guideline and subsequently give correct dietary advice to UC patients(Haskkey,N et al 2017).


Eligibility criteria: Inclusion Criteria:

* patients with ulcerative colitis diagnosed by clinical Endoscopic and histopathological methods

Exclusion Criteria:

-

Patients with any co morbidity ( HTN,DM,Primary sclerosing cholangitis, as those patients need some restrictions of diet which may affect the prognosis of the disease)

Primary outcomes:
measure: Study of demographic and dietary profile in patients with ulcerative colitis in upper Egypt
timeFrame: A year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01299428: Evaluation of the Cerebral Oxygenation With Near Infrared Spectrophotometry (NIRS) at the Hypernatremic Dehydration in Newborn
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HYPERNATREMIA
Keywords: CEREBRAL OXYGENATION
HYPERNATREMİA
NEWBORN
NA VALUES
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry (NIRS) at the hypernatremic dehydration in newborns.


Eligibility criteria: Inclusion Criteria:

* gestation week \> 37 ve Na \>150 mg/dl
* Dehydration

Exclusion Criteria:

* Sepsis
* Intracranial Haemorrhagia
* Congenital Cardiac Diseases

Primary outcomes:
measure: CEREBRAL OXYGENATION
timeFrame: 3 MONTHS
Secondary outcomes:
measure: NEURODEVELOPMENT
timeFrame: 12-18 MONTHS
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
state: Samanpazarı
Study officials:
References: