louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01118195: Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans
Official title: Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury (TBI)
Suicidal Behavior
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2010-05-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient veterans with a history of traumatic brain injury

Brief summary: This is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The purpose of this research is to find out more about the issues related to these conditions. This study seeks to explore the relationship between executive dysfunction and suicidal behavior in an outpatient population.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of traumatic brain injury, history of suicidal behavior.
2. Age 18-74.
3. Currently receiving care through the Eastern Colorado Health Care System (ECHCS) Denver VA TBI Interdisciplinary Team.

Exclusion Criteria:

1. History of other significant neurological disease.
2. Diagnosis of Schizophrenia.
3. Test of Memory Malingering (TOMM) performance lower than 50%.
4. Behavior which could be described as Substance Abuse in the 7 days prior to participation.
5. Current guardianship or mention of recommendation for guardianship in medical chart within the past six months.
6. Inability to read the informed consent document.
7. Inability to adequately respond to questions regarding the informed consent procedure.
8. Significant hearing impairment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05340595: Effect of Primer Application on the Lingual Retainer
Official title: Effect of Self-Etch Primer Application on the Bond Failure Rate of a Mandibular Bonded Lingual Retainer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Bonding
Orthodontic Retainers
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
Collaborators: name: Sabahat Yazıcıoğlu
First posted: 2022-04-22
Enrollment: 26
Sex: ALL
Minimum age (years): 11
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: The aim of this study was to examine the effect of self-etch primer (SEP) application on the bond failure rate of a mandibular bonded lingual retainer over 24 months.

Materials and Methods: After the removal of the orthodontic appliances, the lingual retainers, which were made of six-stranded stainless steel wire 0.0215 inches in diameter, wiil bent and bond onto the lingual surface of all mandibular anterior teeth. The study will performed using a split-mouth design. In the study group, the SEP will be administired to the teeth's lingual surfaces. In the control group, they will etch using 37% phosphoric etchant liquid gel. After etching, the primer wiil be applied. The adhesive resin was applied and the lingual retainer was fitted. The patients will be re-valuated over 24 months. The first bond failures and the amount of adhesive remaining on the tooth will be recorded as the adhesive remnant index (ARI) scores.

The chi-square test will be used to compare the bond failure rates and ARI scores between the groups. The survival rates of the retainers will be estimated using the Kaplan-Meier test. The significance level will P \< 0.05.


Eligibility criteria: Inclusion Criteria:

1. Individuals who will continue to the retention phase after fixed orthodontic treatment,
2. Presence of all mandibular incisor and canine teeth,
3. Good oral hygiene,
4. No caries,
5. No fractures,
6. Healthy periodontal condition,
7. No restorations,
8. No previous bonded retainer,
9. No traumatic parafunctional habits such as bruxism.

Exclusion Criteria:

-

Primary outcomes:
measure: Bond Failure Rate of a Mandibular Bonded Lingual Retainer
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Elekdag-Turk S, Isci D, Turk T, Cakmak F. Six-month bracket failure rate evaluation of a self-etching primer. Eur J Orthod. 2008 Apr;30(2):211-6. doi: 10.1093/ejo/cjm119. Epub 2008 Jan 23.
citation: Sfondrini MF, Cacciafesta V, Scribante A, De Angelis M, Klersy C. Effect of blood contamination on shear bond strength of brackets bonded with conventional and self-etching primers. Am J Orthod Dentofacial Orthop. 2004 Mar;125(3):357-60. doi: 10.1016/j.ajodo.2003.09.022.
Clinical trial NCT02151695: Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
Official title: Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels.

The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetes mellitus type 1 or type 2 complicated by PDR
* Male or female over 18 years
* HbA1c \<11.6% at study entry
* Systolic blood pressure \<160 mmHg and diastolic blood pressure \<105 mmHg at study entry
* Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality

Exclusion Criteria:

* Hypersensitivity to aflibercept or to any of the excipients
* History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
* PDR associated with tractional retinal detachment in the eye studied
* PDR associated with fibrovascular proliferation in the eye studied
* Florid diabetic retinopathy
* Eye infection or periocular active or suspected
* Unbalanced glaucoma in the eye studied
* Other eye disease in the eye studied
* Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied

Primary outcomes:
measure: Percentage of patients with regression of retinal neovascularization between baseline and 12th month.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Nicolas LEVEZIEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04287595: Effect of Orange Aroma on Nausea, Vomiting and Anxiety During Autologous Stem Cell Transplantation
Official title: Inhalation Aromatherapy on Nausea, Vomiting and Anxiety During Autologous Hematopoietic Stem Cell Transplantation: An Open-label Randmized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Anxiety State
Keywords: anxiety
hematopoietic stem cell transplantation
inhalation aromatherapy
nausea
randomized controlled trial
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients undergoing stem cell transplantation for the first time will be entered. Participants will be randomized to one of two study arms: Arm 1: intervention (routine care+ inhalation aromatherapy); Arm 2: Control (Routine care) Hypotheses: (1) Patients receiving inhalation aromatherapy will experience less severe nausea and less frequent vomiting episodes than those receiving only routine care; and (2) patients receiving inhalation aromatherapy will demonstrate lower anxiety levels just after AHSCT than those receiving only routine care.

Detailed description: Earlier research indicates that aromatherapy is promising to relieve in DMSO related nausea and anxiety in autologous stem cell transplant patients. The current study seeks to confirm and extend these findings in a 2-arm, open-label randomized, controlled study of 70 cancer patients undergoing autologous stem cell transplantation. All patients will receive a standardized premedication. Arm 1: Intervention (inhalation aromatherapy with orange essential oil during stem cell infusion); Arm 2: Control (routine care). The researchers hypothesize that inhalation aromatherapy with orange essential oil will be effective in reducing DMSO related nausea and vomiting and demonstrate lower anxiety levels just after autologous stem cell transplantation.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years,
* the absence of any mental conditions including depression, anxiety disorders, psychotic disorders or dementia that may affect the patients' communication abilities

Exclusion Criteria:

* Patients with chronic obstructive pulmonary disease or asthma,
* a history of allergy to orange or orange essential oil,
* presence of persistent nausea and vomiting due to conditioning regimens,
* receiving antiemetic other than routine premedication,
* patients undergoing AHSCT for the second or more time were excluded

Primary outcomes:
measure: Change in nausea severity
timeFrame: At 1st minute of each stem cell infusion bag
measure: change in number of vomiting
timeFrame: From 1st minute of the stem cell infusion to completion of the intervention
Secondary outcomes:
measure: anxiety
timeFrame: Through stem cell infusion completion, an avarege of 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Nur Izgu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03605095: Evidence of Spreading Vasodilation in Human Gingiva
Official title: Non-invasive Imaging of Human Gingival Microcirculation: Effect of Nitric Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nitric Oxide
Vasodilation
Oral Soft Tissue Conditions
Keywords: spreading vasodilation
gingival microcirculation
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to observe the mechanism of spreading vasodilatation on human healthy gingiva. Nitric-oxide donor solutions in lower and higher concentration are used to trigger the vasoactivity.

Detailed description: Spatial regulation of gingival microcirculation has not been revealed yet. Although this could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical, thermal etc. irritation during whole life. It is especially important during flap surgery. Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal resolution, therefore it allows us to study remote effect of local vasodilation such as spreading vasodilation in human gingiva.

The vasodilatator nitric-oxide (NO) donor will be used to trigger remote effect on gingiva. NO donor solutions will be applied in 1 mg/ml and 8 mg/ml nitroglycerin concentrations. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva. The change on blood flow will be monitor at the test well with surrounding gingival area spanning 3 tooth and at the contralateral side by LSCI.

Eligibility criteria: Inclusion Criteria:

* general health
* minimum 5 mm keratinized gingiva at upper front teeth

Exclusion Criteria:

* pregnancy and breast-feeding
* medication (except contraceptives)
* smoking
* periodontitis
* caries
* insufficient marginal integrity

Primary outcomes:
measure: Blood flow change after application of NO agonist
timeFrame: 30 min
Secondary outcomes:
measure: Comparsion of the change in blood flow between genders
timeFrame: 30min
measure: Correlation between the change in blood flow and gingival thickness
timeFrame: 30min
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Janos Vag
Study officials:
References:
Clinical trial NCT04234295: Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
Official title: Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Adults ages 30-50 years
* Non-smokers
* Lean subjects with a BMI of 25 or less, gender specific normal body fat,
* Obese, non-diabetic subjects with a BMI between 30 and 50 and taking no medications affecting glucose metabolism or lipid metabolism
* subjects scheduled for an elective laparoscopic or laparotomy abdominal surgery

Exclusion Criteria:

* Receiving corticosteroid therapy or have a history of asthma, COPD or atopic syndrome
* taking any biologic treatment for any autoimmune disorder
* Taking any leukotriene receptor antagonist acting medications (ex. Montelukast)
* smoking

Primary outcomes:
measure: Number of eosinophils in adipose tissue
timeFrame: baseline
Secondary outcomes:
measure: Correlation between eosinophil content and body mass index (BMI)
timeFrame: baseline
Other outcomes:
measure: Quantification of the difference in gene methylation in eosinophils from lean and obese subjects
timeFrame: baseline
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Elena De Filippis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01434095: Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Central Serous Chorioretinopathy
Keywords: microperimetry
fixation point
retinal sensitivity
photodynamic therapy
chronic central serous chorioretinopathy
Lead sponsor: Surugadai Nihon University Hospital
Sponsor class: OTHER
Collaborators: name: Teikyo University
First posted: 2011-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A half-dose photodynamic therapy, a relative new treatment, has been widely performed to treat central serous chorioretinopathy.

The researchers aimed to investigate whether the therapy improved the patient's visual acuity as well as the retinal sensitivity. The researchers also investigate which clinical factors, if any, were associated with the results; visual acuity or retinal sensitivity after the treatment.

Detailed description: The best-corrected visual acuity (BCVA), macular sensitivity, and fixation stability were evaluated at the baseline and at 1, 3, 6, and 12 months after the half-dose photodynamic therapy. The macular sensitivity and fixation stability were determined by MP-1 microperimetry (Nidek, Vigonza, Italy). The researchers analysed whether the BCVA and retinal sensitivity significantly improved or not. And if yes, the researchers were interested at which period after treatment the significant improvement was found. Also, the researchers investigated which improved first, BCVA or retinal sensitivity.

Eligibility criteria: Inclusion Criteria:

* the presence of subretinal fluid involving the fovea in the Optical coherence tomographic (OCT) images
* a serous retinal detachment of at least 6 months duration.

Exclusion Criteria:

* evidence of a choroidal neovascularization (CNV), polypoidal choroidal vasculopathy, or other maculopathy documented by fluorescein angiography or Indocyanine green angiography

Primary outcomes:
measure: best corrected visual acuity
timeFrame: one year
Secondary outcomes:
measure: retinal sensitivity
timeFrame: one year
Other outcomes:
Locations:
city: Chiyoda-ku
country: Japan
facility: Department of Ophthalmology, Surugadai Nihon University Hospital
state: Tokyo
Study officials:
affiliation: Department of Ophthalmology, Surugadai Nihon University Hospital
name: Kyoko Fujita, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fujita K, Shinoda K, Imamura Y, Matsumoto CS, Mizutani Y, Mizota A, Yuzawa M. Correlation of integrity of cone outer segment tips line with retinal sensitivity after half-dose photodynamic therapy for chronic central serous chorioretinopathy. Am J Ophthalmol. 2012 Sep;154(3):579-85. doi: 10.1016/j.ajo.2012.03.043. Epub 2012 Jul 20.
Clinical trial NCT05152095: Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety
Official title: Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety: A Randomized Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia Due to Anxiety and Fear
Keywords: auricular acupressure
insomnia
anxiety
randomized sham controlled trial
Lead sponsor: International Medical University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a sham-controlled randomized trial to identify the effectiveness of treating insomnia induced by anxiety with self-administered auricular acupressure in Malaysia.

Detailed description: 112 subjects with insomnia and anxiety who fit to the inclusion and exclusion criteria will be recruited into the trial. After initial screening, subjects will be randomly allocated to Vaccaria seed tapes (experimental arm) or non-Varracia seed plain tapes (sham comparator arm).

On the sixth day for the trial (after 5 days of daily auricular acupressure), the ISI and HAM-A score of subjects will be reassessed again. The subjects have to stop applying auricular acupressure for the next five days and reassess their ISI and HAM-A score again on the eleventh day.

Eligibility criteria: Inclusion Criteria:

* All Malaysian aged above 18 years old who are suffering from chronic insomnia based on International Classification of Sleep Disorders 3(ICSD-3) and with Insomnia Severity Index (ISI) of 18 and above and more than 3 months.
* Willing to comply with the recommended periodic acupressure stimulation every day during the 1 week period.

Exclusion Criteria:

* Subject with insomnia score below 18 based on Insomnia Severity Index (ISI).
* Subject with stress and anxiety level below 18 in the Hamilton Anxiety Rating Scale (HAM-A).
* Subject with the history of skin sensitivity.
* Subject who just started on new medication to treat insomnia.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 6th day
measure: Insomnia Severity Index (ISI)
timeFrame: 11th day
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 6th day
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 11th day
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: International Medical University (IMU)
Study officials:
References:
Clinical trial NCT00002295: A Study of Isoprinosine in Patients With Severe AIDS
Official title: A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Infusions, Intravenous
Drug Evaluation
Administration, Oral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Biological Availability
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to:

Laboratory (immunologic defects):

* Comparison of total helper and suppressor T-cell numbers among the groups.
* Comparison of changes in natural killer cell activity.
* Comparison of other laboratory findings among the groups.

Clinical changes:

* Comparison of the frequency of opportunistic infections among the groups.
* Comparison of the frequency of the development of AIDS-related malignancies.
* Comparison of other clinical manifestations relative to severity and time of onset.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded.

Concurrent Medication:

Excluded:

* Steroids.
* Cytotoxic immunosuppressive agents.
* Radiotherapy.

The following are excluded:

* Critically ill patients.
* Patients receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.
* Patients who have received any other immunotherapy.
* Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Prior Medication:

Excluded:

* Any other immunotherapy.

Patients with severe AIDS and specified laboratory immunologic defects.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Newport Pharmaceuticals International Inc
state: California
Study officials:
References: