louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02180100: Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Official title: A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vulvovaginal Candidiasis
Lead sponsor: Peking University Shenzhen Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Shyndec Pharmaceutical Co., Ltd.
First posted: 2014-07-02
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

Detailed description: This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.

Eligibility criteria: Inclusion Criteria:

* Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
* Subject completes the informed consent process
* Subject agrees to take study medication when scheduled
* Subject complies with all clinical trial instructions. Commits to all follow-up visits
* Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment

Exclusion Criteria:

* had any other sexually transmitted disease or gynaecological abnormality requiring treatment
* had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
* had used antifungal medication in the week before entry; or
* were expected to menstruate within seven days of the start of treatment
* infected more than one candida species

Primary outcomes:
measure: Mycological Cure 1
timeFrame: Between day 7-14 after treatment, an average of 10 days
Secondary outcomes:
measure: Mycological Cure 2
timeFrame: Between day 28-35 after treatment, an average of 30 days
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hosptal
state: Guangdong
Study officials:
affiliation: Peking University Shenzhen Hospital
name: Shangrong Fan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li T, Zhu Y, Fan S, Liu X, Xu H, Liang Y. A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis. Med Mycol. 2015 Jun;53(5):455-61. doi: 10.1093/mmy/myv017. Epub 2015 Apr 15.
Clinical trial NCT01684852: Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution
Official title: Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution (BAT04) Compared to HA Eye Drops in the Treatment of Dry Eye Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Keywords: dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic The selection of appropriate patients for the observational study is made by the individual physician in his treatment decisions in consultation with the individual patient

Brief summary: This is a comparative, open label, parallel group, non interventional study to further demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product according to the instructions for use six times daily in both eyes over a period of 28 days. Response to treatment is recorded at day 28.


Eligibility criteria: Inclusion Criteria:

* Male or female person aged 18 years
* Demonstrated mild to moderate keratoconjunctivitis sicca ( "dry eye")
* Acute symptoms of dry eye: DEWS 1-3
* tear break-up time TBUT \<10s
* agreement to abide by the routinely provided doctor's appointment for follow-up (reflected in the planned visits of observation plan resist)

Exclusion Criteria:

* inflammation of the anterior segment or trauma
* Contact lens wearers
* Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
* Patients with known intolerance to one of the substances used
* Surgical procedures to the eyes in the last 6 weeks before inclusion in the trial
* patients with addictive disorders or substance abuse fallow in the past 12 months, as well as persons incapable of giving consent

Primary outcomes:
measure: Tear Break Up Time
timeFrame: V1 and V2
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Liebenwerda
country: Germany
facility: Dr. Peter Otto
city: Duderstadt
country: Germany
facility: Dr. Insa Beddermann
city: Erlangen
country: Germany
facility: Augenklinik mit Poliklinik
city: Muenchen
country: Germany
facility: Augenklinik der LMU Klinikum der Universität Muenchen
city: Muenster
country: Germany
facility: Augenabteilung am St. Franziskus-Hospital Münster
Study officials:
affiliation: Augenklinik der LMU Klinikum der Universität München
name: Elisabeth Messmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06567652: Safety and Efficacy of Persistent Atrial Fibrillation Ablation With a Cryoballoon Technology
Official title: Safety and Efficacy of Persistent Atrial Fibrillation Ablation With a Cryoballoon Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persistent atrial fibrillation patients undergoing first atrial fibrillation ablation procedure with PolarX cryoballoon

Brief summary: The goal of this retrospective observational study is to learn about the safety and efficacy of cryoballoon catheter ablation in 80 patients with persistent atrial fibrillation using the PolarX (Boston scientific) cryoablation technology. The main question it aims to answer is if it is safe and effective.


Eligibility criteria: Inclusion Criteria:

* persistent atrial fibrillation patients undergoing first atrial fibrillation ablation procedure with PolarX cryoballoon

Exclusion Criteria:

* previous atrial fibrillation ablation or cardiac surgery,
* paroxysmal atrial fibrillation,
* congenital heart disease,
* non-treated coronary artery disease,
* intracavitary thrombus,
* significant valvular disease,
* contraindications to general anesthesia.

Primary outcomes:
measure: Effectiveness
timeFrame: 1 year follow-up
measure: Safety of the procedure
timeFrame: The safety endpoint was evaluated at 7-days 30-days and 1-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel Heart Rhythm Management Center
Study officials:
References:
Clinical trial NCT02395952: Healing of Persistent Epithelial Defects
Official title: Comparison of Standard of Care Treatments for Post-operative Non-healing Epithelial Defects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cornea
Keywords: cornea
epithelial defect
amniotic membrane
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 0
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: The purpose of this study is to compare the relative efficacy of four different treatment modalities (i.e. aggressive lubrication, bandage contact lens, Ambiodisk amniotic membrane, Prokera amniotic membrane) in the healing of persistent corneal epithelial defects following retina surgery.


Eligibility criteria: 3.1 Inclusion Criteria

* Adults aged 18 and older (inclusive) at the time of study enrollment
* Recent history of retina surgery
* Presence of persistent epithelial defect 7 days or later after surgery
* English speaking

3.2 Exclusion Criteria

* Non-English speaking patients
* Inability to incapacity to provide consent for the study
* History of corneal epithelial or limbal stem cell disease

Primary outcomes:
measure: Abscence of persistent epithelial defect
timeFrame: 22 days
Secondary outcomes:
measure: Rate of epithelial healing in mm2/day
timeFrame: 22 days
measure: Infection
timeFrame: 22 days
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Eye Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03889652: Optical Coherence Tomography of Nerve Fiber Layer and Ganglion Cell Complex After Cataract Extraction
Official title: Comparison Between OCT Nerve Fiber Layer and Ganglion Cell Complex Parameters Following Cataract Extraction in Patients With or Without Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Primary Open-angle Glaucoma
Keywords: Retinal nerve fiber layer (RNFL)
Ganglion cell complex (GCC)
Optical coherence tomography (OCT)
Primary open angle glaucoma (POAG)
Cataract
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cataract without any other concomitant retinal, optic nerve head pathology other than POAG are included in the study and divided into two groups Group 1 patients with cataract only Group 2 patients with cataract and POAG who are planned for cataract surgery only and controlled on medical treatment

Brief summary: Optical coherence tomography (OCT) for retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) is done before and after cataract extraction in patients with or without primary open angle glaucoma (POAG)

Detailed description: The investigator's study includes two groups of patients, each consists of 25 eyes, group 1 (cataract group)includes patients who are planned for cataract extraction without any other preexisting retinal or optic nerve pathology that may affect the RNFL thickness, while group 2 (combined cataract and glaucoma group) includes patients who are diagnosed with POAG controlled on medical treatment with cataract and planned for cataract extraction only.

The OCT scans with complete ophthalmological examination are done before surgery and 6 weeks after uneventful cataract extraction (phacoemulsification with intraocular lens implantation)

Eligibility criteria: Inclusion Criteria:

• patients with cataract without any other concomitant retinal, optic nerve head pathology other than POAG are included in the study and divided onto two groups

Exclusion Criteria:

* Patients having any retinal or optic nerve pathology that might have affected nerve fiber layer thickness other than POAG eg: high myopia
* POAG patients who are planned for combined surgery
* Refractive errors greater than spherical equivalent of 6 diopters (myopia or hypermetropia)
* Dense cataract hindering OCT imaging
* History of previous ocular surgery or trauma

Primary outcomes:
measure: RNFL and GCC thickness
timeFrame: Oct scans before and 6 weeks after surgery
Secondary outcomes:
measure: Final best corrected visual acuity (BCVA)
timeFrame: Six weeks after cataract surgery
Other outcomes:
measure: Intraocular pressure (IOP) change and central foveal thickness (CFT) change
timeFrame: Six weeks after cataract surgery
Locations:
city: Cairo
country: Egypt
facility: Kasr Al-Ainy teaching hospital
Study officials:
References:
Clinical trial NCT01215552: Study of the Inhibition of [11C]R-rolipram Binding to Brain Phosphodiesterase - 4 (PDE-4) by HT-0712
Official title: A PET Study: Single-dose, Open-label Study of the Inhibition of [11C]R-rolipram Binding to Brain Phosphodiesterase - 4 (PDE-4) by HT-0712
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Elderly Volunteers
Lead sponsor: Dart NeuroScience, LLC
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 3
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This Positron Emission Tomography (PET) imaging study is designed to explore the relationship between HT-0712 dose level and inhibition of brain phosphodiesterase-4 activity, in order to optimize the dosage regimens utilized in subsequent trials.

Detailed description: The objective of this project is to demonstrate the inhibition of human brain PDE4 by HT-0712, by measuring the inhibition of \[11C\]R-rolipram binding, a radiotracer which also binds to and inhibits PDE4. Plasma samples will be drawn to determine if there is a relationship between plasma pharmacokinetics of HT-0712 and its pharmacodynamic effect, as determined through the inhibition of \[11C\]R-rolipram binding in the brain.

Eligibility criteria: Main Inclusion Criteria:

* Healthy, elderly, non-smoking men and post-menopausal women
* Ability to give informed consent

Main Exclusion Criteria:

* Current or history of uncontrolled hypertension, major depression, Parkinson's disease, stroke and diabetes.
* Physical or behavioral conditions that may alter brain function

Primary outcomes:
measure: PET measurement of HT-0712 inhibition of [11C]R-rolipram binding
timeFrame: 1 day
Secondary outcomes:
measure: Brain uptake of [11C]R-rolipram, as determined by PET imaging, associated with both maximal plasma concentration of HT-0712 (Tmax) and overall plasma level exposure (AUC) following administration of different dose levels of HT-0712.
timeFrame: 1 day
Other outcomes:
Locations:
city: Upton
country: United States
facility: Brookhaven National Laboratory
state: New York
Study officials:
affiliation: Dart NeuroScience, LLC
name: Philip Perera, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02083952: Impact of Swaddle Blanket on Gastroesophageal Reflux
Official title: Impact of Swaddle Blanket on Gastroesophageal Reflux
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Apnea
Bradycardia
Oxygen Desaturations
Lead sponsor: Valley Health System
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. A novel approach to the mangement of GERD in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and pH (acid) changes.


Eligibility criteria: Inclusion Criteria:

- NICU patients who have a 5 channel study requested by the attending neonatologist -

Exclusion Criteria:

-

Primary outcomes:
measure: pH
timeFrame: 24 hours
Secondary outcomes:
measure: apnea
timeFrame: 24 hours
Other outcomes:
measure: bradycardia
timeFrame: 24 hours
measure: oxygen desaturations
timeFrame: 24 hours
Locations:
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
Study officials:
affiliation: The Valley Hospital
name: Mary T Carbone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00809952: Ultrasound Guided Artificial Insemination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insemination
Lead sponsor: Hospital de Cruces
Sponsor class: OTHER
First posted: 2008-12-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to ascertain whether using ultrasound guidance during intrauterine insemination (IUI) could increase pregnancy rates.


Eligibility criteria: Inclusion Criteria:

* The woman's inclusion criteria in our IUI program were at least one patent tube, normal cavity, basal FSH \< 10 mU/mL and age under 40 years.
* IUI with husband's sperm (IUI-H) was indicated when, after sperm preparation, at least 5 million motile spermatozoa were recovered; this was performed in 58 cases (79.45%).
* In the remaining 15 cases (20.55%), IUI was performed with donor sperm (IUI-D) either because of azoospermia (n=6) failure to recover spermatozoa during testicular biopsy (n=5) or in women without a male partner (n=4).

Exclusion Criteria:

* Previous infertility treatments had been carried out.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cruces-Baracaldo
country: Spain
facility: Human Reproduction Unit
state: Basque Country
Study officials:
References:
citation: Ramon O, Matorras R, Corcostegui B, Meabe A, Burgos J, Exposito A, Crisol L. Ultrasound-guided artificial insemination: a randomized controlled trial. Hum Reprod. 2009 May;24(5):1080-4. doi: 10.1093/humrep/den498. Epub 2009 Feb 5.
Clinical trial NCT01053052: Study of FemVue(TM) Sono Tubal Evaluation System Method Comparison to HSG
Official title: A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fallopian Tube Patency Tests
Keywords: Patency Tests, Fallopian Tubes
Hysterosalpingography
Sonography, Medical
Lead sponsor: Femasys Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Multi-center prospective comparison of fallopian tubal patency determination and uterine evaluation interventions using legally marketed devices for their intended purposes, and using each subject as their own control.

Detailed description: Study cancelled prior to recruitment.

Eligibility criteria: Inclusion Criteria:

Non-pregnant women between the ages of 18 and 45 who desire to know the patency status of the fallopian tubes and if the uterine cavity is free of pathology who have:

* Been attempting conception for 6 months or
* A history of PID (including the conditions listed below) or

  * Chlamydia
  * Gonorrhea
  * Endometriosis
* A history of pelvic surgery or
* Advanced maternal age (≥ 35) And
* Negative test for Gonorrhea/Chlamydia or prophylactic antibiotic treatment
* Without current bi-lateral tubal sterilization
* Signed Informed Consent

Exclusion Criteria:

Uterine anomaly or lesion(s) preventing catheter placement for either the FemVue or HSG procedure(as identified and documented by TVUS Screening procedure or the uterine cavity evaluation during the FemVue procedure or any previous diagnostic procedure)

* obstructing access to uterine cornu
* distorting fundus at the midline region

Primary outcomes:
measure: Concordance of evaluations of fallopian tube patency and intrauterine pathology.
timeFrame: Day 1
Secondary outcomes:
measure: subject discomfort assessment
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02997852: Biobehavioral Effects of Therapy Dog Visitation in Elderly Intensive Care Unit Patients: A Pilot and Feasibility Study
Official title: Biobehavioral Effects of Therapy Dog Visitation in Elderly Intensive Care Unit Patients: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosocial Stress
Keywords: human-animal interaction
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The Methodist Hospital Research Institute
First posted: 2016-12-20
Enrollment: 15
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: The purpose of this study is to assess the preliminary efficacy of a 10-minute therapy dog visitation (TDV) in reducing biobehavioral stress responses.


Eligibility criteria: Inclusion Criteria:

* ≥50 years old
* able to provide consent and understand English
* able to complete study instruments

Exclusion Criteria:

* currently taking hormone replacement or steroidal anti-inflammatory medications,
* in contact precautions at facility,
* diagnosed with Addison's or Cushing's disease
* fears or phobias to dogs, or allergies to dogs.

Primary outcomes:
measure: Change in stress as assessed by the Stress-Visual Analog Scale
timeFrame: immediately before TDV, immediately after TDV
measure: Change in Anxiety as assessed by the Faces Anxiety Scale
timeFrame: immediately before TDV, immediately after TDV
measure: Change in Mood as assessed by the Positive and Negative Affect Schedule
timeFrame: immediately before TDV, immediately after TDV
measure: Change in biological stress response as assessed by salivary cortisol levels
timeFrame: immediately before TDV, immediately after TDV
measure: Change in biological inflammatory stress responses as assessed by salivary C-reactive protein (CRP) levels
timeFrame: immediately before TDV, immediately after TDV
measure: Change in biological inflammatory stress responses as assessed by salivary interleukin-1beta (IL-1β) levels
timeFrame: immediately before TDV, immediately after TDV
Secondary outcomes:
measure: Attachment level to pets as assessed by the Pet Attitude Scale (PAS)
timeFrame: immediately before TDV
measure: Human-Animal Interaction as assessed by the Human-Animal Interaction Scale (HAIS)
timeFrame: immediately after TDV
measure: Human-Animal Interaction as assessed by the HAIS observer questionnaire
timeFrame: immediately after TDV
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sandra M Branson, PhD, MSN, RN
role: PRINCIPAL_INVESTIGATOR
References: