louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02925182: Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation
Official title: Treatment of Recurrent Aphthous Stomatitis With Er,Cr:YSGG Laser Irradiation: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomatitis, Aphthous
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim this study was to investigate the efficacy of Er,Cr:YSGG laser irradiation in reducing pain and on healing rate of recurrent aphthous stomatitis 40 patients with RAS were included to the study. For each patient, ulceration were randomly assigned to the test or the control group. In test group RAS irradiated with Er,Cr:YSGG laser using non-contact mode. In the placebo group, the same Er,Cr:YSGG laser without laser emission was used. Pain was evaluated with visual analog scale (VAS). Healing of RAS (HRAS) was graded by a clinician.


Eligibility criteria: Inclusion Criteria:

* For inclusion every patient had to have one pairs of minor RAS duration of 3 days or less, in the buccal or labial nonkeratinized oral mucosa.

Exclusion Criteria:

* Patients with a known systemic disease that predisposed them to RAS (e.g., Behçet disease), presence of any major herpetic lesions, traumatic ulcers, ulcers caused due to topical or systemic medications, or undergoing systemic or local treatment for RAS were excluded.

Primary outcomes:
measure: Reduce of Visual Analog Scale (VAS) scores
timeFrame: 10 days
Secondary outcomes:
measure: The healing of recurrent aphthous (HRAS) scores
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Near Easat University, Faculty of Dentistry
name: Hasan Guney YILMAZ, DDS, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03124082: OFA - Opioid Free Anesthesia
Official title: Study Protocol "OFA: Opioid-Free Anesthesia".
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blind trial
Primary purpose: TREATMENT

Brief summary: Opioids have been used for analgesia since many years, but despite potent analgesia they are also associated to side effects, including opioid induced Hyperalgesia (OIH).

OIH in the surgical setting is debated, and may predispose patients to higher analgesic consumption in the preoperative period, and peripheral and central sensitization. The aim of the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine, ketamine) for intraoperative management of patients undergoing laparoscopic left hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System) sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered, together with any side effect and parameters of surgical rehabilitation.


Eligibility criteria: Inclusion Criteria:

* left hemicolectomy
* signed informed consent
* \>18 ys

Exclusion Criteria:

* \>90 ys \<18 ys
* no consent
* pregnancy
* psychiatric disease
* cardiac failure, aortic or mitral valve severe stenosis
* kidney or hepatic failure
* atrio-ventricular type II block
* immunodepression
* emergency surgery
* ICU admittance
* drug or alcohol abuse
* chronic pain

Primary outcomes:
measure: analgesic consumption
timeFrame: 24 HOURS
Secondary outcomes:
measure: side effects
timeFrame: 4 days after surgery
measure: Pain Score on the Visual Analog Scale
timeFrame: 3 months
measure: peripheral sensitization
timeFrame: 24 hours
measure: central sensitization
timeFrame: 24 hours
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University Hospital
Study officials:
References:
Clinical trial NCT01714882: Stress Management for Couples Undergoing In Vitro Fertilization (IVF)
Official title: Stress Management for Couples With Infertility Undergoing In Vitro Fertilization (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: Infertility
In Vitro Fertilization (IVF)
Stress Management
Stress Reduction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).

Detailed description: The investigators are trying to determine two different stress management techniques in couples undergoing IVF. One arm will be randomized to learning these techniques by themselves by watching and following instructions on a digital video disc (DVD). The other arm will have an in-person class that will teach the couples different stress reduction techniques.

Eligibility criteria: Inclusion Criteria:

* Women with clinical infertility, either primary or secondary, who are recommended for IVF for the first time as part of their treatment for infertility
* Women with a partner, and both are willing to provide consent for study participation as a couple
* Couples that can be reached by telephone for follow-up

Exclusion Criteria:

* Women less than 18 years of age
* Women equal or greater than 40 years of age
* Women with a history of recurrent pregnancy loss
* History of current or recent psychotic episode within past 6 months for either the woman or her partner
* Couples needing a interpreter for their clinical encounter

Primary outcomes:
measure: Change of Scores from questionnaires from baseline to 6 and then 12 weeks
timeFrame: Baseline, 6 and 12 weeks after randomization
Secondary outcomes:
measure: Clinical Pregnancy rate
timeFrame: 12 months after randomization
Other outcomes:
measure: Clinical or biochemical miscarriage
timeFrame: 12 months after randomization
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amit Sood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Zaraq Khan, MBBS
role: STUDY_CHAIR
References:
Clinical trial NCT04369482: Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL
Official title: Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age Related Cataracts
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
Primary purpose: DIAGNOSTIC

Brief summary: On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an Clareon, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.

A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
* Age 50 and older
* Visual potential in both eyes of 20/30 or better as determined by investigators estimation
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Preceding intraocular surgery or ocular trauma
* Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
* Laser treatment
* Uncontrolled systemic or ocular disease
* Infectious disease
* Pregnancy/Nursing

Primary outcomes:
measure: PCO score
timeFrame: 3 years
Secondary outcomes:
measure: Visual Acuity
timeFrame: 3 years
measure: Fibrosis
timeFrame: 3 years
measure: Subjective glistening score
timeFrame: 3 years
measure: YAG capsulotomy rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna Allgemeines Krankenhaus
Study officials:
References:
Clinical trial NCT05821582: Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens
Official title: Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Colorectal Cancer
Lead sponsor: Sanguine Biosciences
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with active colorectal cancer

Brief summary: The primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.

Detailed description: STUDY DESIGN:

* This protocol is a single-center, single-cohort, bioresearch study enrolling up to 8 participants. The cohort is as follows:
* Cohort 1: Colorectal Cancer: (n=8)
* The study will enroll participants per the eligibility criteria.
* Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact (see section 11.0 for details). The biospecimens collected from participants on this study are stool samples.
* Confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the disease cohort before they are considered fully enrolled.

Eligibility criteria: Cohort 1: Colorectal Cancer

Inclusion:

1. The participant is willing and able to provide written informed consent
2. The participant is willing and able to provide appropriate photo identification
3. Participants aged 18 to 85, Inclusive
4. Participants have been diagnosed with Active Colorectal Cancer (CRC)
5. Subjects currently taking irinotecan

Exclusion:

1. Participants who are pregnant or are nursing
2. Participants with a known history of HIV, hepatitis, or other infectious diseases
3. Participants who have taken an investigational product in the last 30 days
4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
5. Subjects who are currently in remission for CRC.

   * Preference (not required for enrollment into study): Exclude subjects currently taking antibiotics\*

Primary outcomes:
measure: Primary Objective- Intestinal side effects of chemotherapy
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Sanguine Biosciences, Inc.
state: Massachusetts
Study officials:
affiliation: Sanguine Biosciences
name: Andrew C Frisina, M.S.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01163682: Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
Official title: Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Neuropathy
Keywords: taxane induced neuropathy
taxane induced myalgias
electro-acupuncture
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2010-07-16
Enrollment: 63
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study seeks to determine if 12 weeks of weekly electro-acupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of taxane treatment.

Detailed description: Chemotherapy induced neuropathy (CIN) is a common and disabling toxicity of cytotoxic chemotherapy. Depending on the drug, it is often irreversible even after the offending agent is removed. The consequence of terminating effective anti-tumor therapy or dose reduction can be catastrophic to the effect of a patient's cancer treatment. Given the morbidity of taxane induced neuropathy, the lack of effective preventative treatment for taxane induce neuropathy and the safety of acupuncture, it is reasonable to test the efficacy of this non pharmacological intervention in woman with Stage I-III breast cancer receiving adjuvant or neo-adjuvant weekly paclitaxel for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Age\>21 years
* History of stage I-III breast cancer
* Patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for 12 weeks
* Signed informed consent

Exclusion Criteria:

* Previous treatment with acupuncture in the last 12 months
* Diabetic Neuropathy or other neurological conditions
* Inflammatory, metabolic or neuropathic arthropathies
* Current narcotic use
* Severe concomitant illnesses
* Severe coagulopathy or bleeding disorder
* Dermatological disease within the acupuncture area
* Have a pacemaker

Primary outcomes:
measure: Change in Brief Pain Inventory-Short Form Score
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Change in FACT-TAX Score
timeFrame: Baseline, 16 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Dawn L Hershman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02172482: Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 63127
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: As part of the post-marketing surveillance, information is to be gathered regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Men and women aged at least 40 years presenting with the symptoms of COPD

Exclusion Criteria:

* Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Primary outcomes:
measure: Change from baseline in breathlessness when walking/climbing stairs
timeFrame: Baseline, after 4 weeks
measure: Change from baseline in overall severity of the clinical picture
timeFrame: Baseline, after 4 weeks of treatment
measure: Occurrence of Adverse Events
timeFrame: up to 4 weeks
measure: Change from baseline in breathlessness on Physical exercise
timeFrame: Baseline, after 4 weeks
measure: Change from baseline in breathlessness during housework
timeFrame: Baseline, after 4 weeks
measure: Change from baseline in breathlessness during everyday activities
timeFrame: Baseline, after 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06922682: Training About Sudden Infant Death Syndrome
Official title: The Effect of Providing Pregnant Women Training on Sudden Infant Death Syndrome (SIDS) on the Post-Partum Risky Behaviors: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Infant Death
Keywords: Sudden Infant Death
newborn
mother
risk factors
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 52
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a parallel group, randomized, controlled experimental study.
Primary purpose: PREVENTION

Brief summary: Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. The study aims examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers.

Detailed description: Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. To examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers. Pre-test post-test designed, randomized controlled, experimental study was conducted in Turkey, 2024. Sixty pregnant women were employed in intervention and control groups. Face-to-face training on risk factors triggering sudden infant death syndrome was provided to pregnant women in intervention group. Study data were collected using "Personal Information Form, Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire". Data were collected face to face before training and after training and via telephone 2 months after training.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who were in the 38th week of their pregnancy and older,
* Lived a healthy pregnancy,
* Had no communication problems,
* Can speak and understand Turkish,
* Agreed to participate in the study were included.

Exclusion Criteria:

* Pregnant women who were earlier than 38 weeks pregnant,
* Had difficulty in communicating,
* Were illiterate and unable to speak Turkish,
* Who filled out the forms incompletely were not included.

Primary outcomes:
measure: Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire
timeFrame: 20 minutes before training, just after training and 2 month later
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Gynecology and Children's Diseases Hospital in Turkey
state: Black Sea Zone
Study officials:
affiliation: Ondokuz Mayis Univeristy
name: Hatice Uzsen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02921282: Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms
Official title: Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cigarette Smoking Behavior
Keywords: genes
cues
reward
smoking
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Otherwise healthy smokers will be recruited

Brief summary: In this study, potential associations between several genetic polymorphisms and nicotine dependence will be examined. The relative reinforcing efficacy of cigarettes using the forced-choice procedure will be assessed. In addition, reactivity to smoking cues using a reliable procedure will be conducted.

Detailed description: It is known that cannabinoid and dopamine receptors can be important modulators of response to nicotine and its associated cues. In this study participants will be genotyped to determine whether there is a relationship between CB1 or D3 genes and the reinforcing properties of nicotine or the subjective effects of nicotine-associated cues. In one session, participants will chose between two different cigarettes, each with different properties. In another session, physiological responses and craving will be measured when presented with cues that remind participants of nicotine. At some point during the study, blood will be collected for genotyping and this will processed to study whether CB1 or D3 genotype influences these responses to nicotine or cues.

Eligibility criteria: Inclusion Criteria:

1. 19-64 year old males and females
2. smoking at least 10 cigarettes per day for at least 1 year
3. positive urinary cotinine
4. medically and psychologically healthy as determined by screening criteria

Exclusion Criteria:

1. definite plan to reduce or quit tobacco use during the course of the study
2. treatment for tobacco dependence in the past 3 months
3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
4. consumption of more than 15 alcoholic drinks per week during the past month
5. use of any illicit drug more than twice per week during the past month
6. current use of any medication that would interfere with the protocol in the opinion of PI
7. under the influence of a drug or alcohol at any session
8. pregnant, nursing, or become pregnant during the study

Primary outcomes:
measure: Number of puffs on a cigarette
timeFrame: 3 years
Secondary outcomes:
measure: Craving in response to nicotine cues
timeFrame: 3 years
measure: Physiological measures in response to cues
timeFrame: 3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: CAMH
name: Bernard Le Foll, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: