louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06570720: Alcohol-focused Support of Survivors in Sororities Training (ASSIST) - Pilot
Official title: ASSIST Study: Pilot Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking in College
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-08-26
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to conduct a preliminary evaluation of the ASSIST (Alcohol-focused Support of Survivors in Sororities Training) intervention in sorority chapters. ASSIST is a newly developed web-based intervention to increase peer support of sexual assault survivors and reduce encouragement of drinking to cope within social networks of sororities. To test whether the intervention is feasible and shows preliminary signs of working, a pilot cluster randomized trial will be conducted. Sorority chapters will be recruited and randomly assigned to an intervention condition or an assessment-only condition. Individuals within each sorority will be recruited and complete a norm documentation survey. One month later, participants will complete a baseline survey, and if assigned to the intervention condition, will then receive the web-based ASSIST intervention, which will include normative feedback on values and drinking, psychoeducation about sexual assault recovery and the role of alcohol, and skills training in behaviors that can be used to support survivors without or while moderating heavy drinking. All participants will complete online follow-up surveys at 1-, 3-, and 6-months post-intervention.


Eligibility criteria: Chapter-Level Inclusion Criteria:

* Greek organization of undergraduate women recognized by the Office of Fraternity \& Sorority Life with a physical house for chapter members
* At least 80 active members

Individual-Level Inclusion Criteria:

* Aged 18 years or older
* Current student
* Active member in a participating sorority chapter

Exclusion Criteria:

* \[None\]

Primary outcomes:
measure: Perceived helpfulness
timeFrame: Immediate post-intervention
measure: Social Support
timeFrame: Baseline; 1-, 3-, and 6-month follow-up
measure: Alcohol use
timeFrame: Baseline; 1-, 3-, and 6-month follow-up
measure: Alcohol-related consequences
timeFrame: Baseline; 1-, 3-, and 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Anna Jaffe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05810220: Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Official title: Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deafness
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Cochlear Americas
First posted: 2023-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices. The study will evaluate different aspects of hearing and auditory processing in the users of implantable auditory devices.


Eligibility criteria: Inclusion Criteria:

* Hearing impaired adult and or child (above 2 years old) who uses ABIs or cochlear implants.
* No diagnosis of any other communicative or cognitive disorder other than hearing impairment. The individual must be able to visit the lab in order to participate in behavioral and electrophysiological experiments.
* Patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation.

Exclusion Criteria:

* Diagnosed cognitive or communicative disorders (other than hearing impairment)
* Severe neurological disorders
* No useable electrodes in their implants

Primary outcomes:
measure: Percent of Correctly-Identified Speech Materials
timeFrame: Day 1 (Visit 1 - Average visit length is about 3 hours)
measure: Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented
timeFrame: Day 1 (Visit 1 - Average visit length is about 3 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mahan Azadpour
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03305120: Musculo-scrawny Manifestation Associated With the Endometriosis
Official title: Musculo-scrawny Manifestation Associated With the Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient consulting in gynecologic service of GHPSJ

Brief summary: The endometriosis is defined by the presence of endometriosic tissue outside of the womb and the prevalence is estimated to be 10% of women.Here is a project aimed to compare musculo-scrawny pains between patients with endometriosis and whose don't suffer of this pathology;


Eligibility criteria: Inclusion Criteria:

* age between 18 and 45
* consulting in Service of gynecology
* First trimester of pregnancy or for pap smears

Exclusion Criteria:

* endometriosis diagnostic already done
* rhumalogic disease known
* age \< 18 and \> 50
* menopause

Primary outcomes:
measure: VAS of musculo-scrawny pain
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT02920320: iCompassion: Internet-based Self-help for More Self-compassion
Official title: iCompassion: Internet-based Self-help for More Self-compassion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-criticism
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 122
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: In this study, people who suffer from strong self-critical tendencies will be randomized to two study conditions. The first group receives an account to an internet-based self-help intervention. The second group is a waiting control group. In both conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of an internet-based self-help intervention on depressive, anxiety and stress symptoms compared to a waiting list. Assessments are at baseline, 8-week and 6-months post-randomization. After 8 weeks, participants in the waiting control group get also access to the intervention and fill out questionnaires after 8 weeks again.


Eligibility criteria: Inclusion Criteria:

* Increased levels of self-criticism
* 18 years or older
* Internet account
* Sufficient German language skills
* Written informed consent

Exclusion Criteria:

* Substance dependence, psychotic disorder, bipolar disorder
* Acute suicidality

Primary outcomes:
measure: Depression anxiety stress scale (DASS)
timeFrame: 8-week
Secondary outcomes:
measure: Self-Compassion Scale
timeFrame: Baseline, 8-week, 6-month
measure: Mini International Neuropsychiatric Interview
timeFrame: Baseline, 8-week
measure: Forms of Self-Criticism and Self-Reassurance Scale
timeFrame: Baseline, 8-week, 6-month
measure: Comprehensive Inventory of Mindfulness Experiences
timeFrame: Baseline, 8-week, 6-month
measure: Positive and Negative Affective Schedule
timeFrame: Baseline, 8-week, 6-month
measure: Fear of Self-Compassion Scale
timeFrame: Baseline, 8-week, 6-month
measure: Satisfaction with Life Scale
timeFrame: Baseline, 8-week, 6-month
measure: Questionnaire for the Assessment of Adaptive and Maladaptive Shame
timeFrame: Baseline, 8-week, 6-month
measure: Rosenberg Self-Esteem Scale
timeFrame: Baseline, 8-week, 6-month follow-up
measure: Client Satisfaction Questionnaire
timeFrame: 8-week
measure: Depression anxiety stress scale (DASS)
timeFrame: 6-month
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Tobias Krieger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03653520: Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
Official title: Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Avanti Anesthesia
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 651
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 investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.

Detailed description: The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the current regimen (valium only) or a combination similar to the MKO melt (valium + tramadol + zofran) are as good if not better than the MKO melt for anesthesia and how many patients could have indeed gone with an intravenous line (didn't need any extra medications).

Eligibility criteria: Inclusion Criteria:

* All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center

Exclusion Criteria:

* Age \<18 years
* Patient is not suitable for the medications for reasons such as unsteady gait, cane, wheelchair, severe dementia (unable to consent), terminal illness
* Allergy to a medication in protocol

Primary outcomes:
measure: Number of patient who needed additional IV medication for cataract surgery
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Kirby Glen Surgery Center
state: Texas
Study officials:
affiliation: Avanti Anesthesia
name: Maggie Jeffries, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01570920: Effects of Regular Brisk Walking in Chronic Stroke Patients
Official title: Effects of Regular Brisk Walking in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Activity limitations
restriction of participation
chronic stroke survival
physical activity
walking
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic stroke patients (\>6 months) fulfilling including criteria were trained during 3 months. The physical training program was based on walking.

Detailed description: Participants had been evaluated 4 times during a long follow-up period of 7 months. Activity limitations were assessed at baseline (enrollment time point), 1 month, 4 months and 7 months later.

Eligibility criteria: Inclusion Criteria:

* Stroke onset \> or = 6 months
* Able to walk without human assistance (may use walking aid)
* Sign informed consent form
* Approval from physician for participation in study
* Live in Belgium or in Benin

Exclusion Criteria:

* cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure
* orthopedic, circulatory, or chronic pain conditions restricting exercise;
* dementia;
* severe receptive or global aphasia with inability to follow 2-step commands;
* co-morbid non-stroke neurological disorder that impairs mobility (e.g. MS or Parkinson's);

Primary outcomes:
measure: ACTIVLIM-Stroke (Activity limitations measures)
timeFrame: 7 months
Secondary outcomes:
measure: Stroke Impairment
timeFrame: 7 months
measure: Walking ability
timeFrame: 7 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut of Neuroscience (IoNS) / UCL, 5375
Study officials:
affiliation: Université Catholique de Louvain, Belgium
name: Jean-Louis Thonnard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Batcho CS, Stoquart G, Thonnard JL. Brisk walking can promote functional recovery in chronic stroke patients. J Rehabil Med. 2013 Sep;45(9):854-9. doi: 10.2340/16501977-1211.
Clinical trial NCT00367120: Zmax Compared to Augmentin in Sinusitis
Official title: A Multicenter, Randomized, Open Label Comparative Study Of Azithromycin Extended Release (ZMAX) Versus Amoxicillin/Clavulanate Potassium In Subjects With Acute Bacterial Sinusitis (ABS) In A Physician Practice Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sinusitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-22
Enrollment: 762
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 study will enroll patients with Bacterial Sinusitis who will be treated with either Zmax (Azithromycin Extended Release) or Augmentin (Amoxicillin/Clavulanate). The purpose of the study is to compare early resolution of symptoms between the two treatments. Patients will report resolution of their sinusitis symptoms through a daily questionnaire. There will be two follow-up telephone interviews on days 12 and 28 to evaluate quality of life, satisfaction with therapy, and use of healthcare services.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of acute uncomplicated bacterial maxillary sinusitis as demonstrated by presence of the following cardinal signs and symptoms for a minimum duration of 7 days, and no longer than 30 days:
* Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
* Presence of one or more of the following signs:
* Discolored (yellow-green) nasal discharge
* Discolored (yellow-green) drainage in the posterior pharynx
* Discolored (yellow-green) discharge from the maxillary sinus orifice
* Two or more of the following symptoms are present:
* Fever, as defined by:
* Oral temperature: \>38C or \>100.4F, or
* Tympanic temperature: \>38.5C or \>101.2F
* Frequent coughing
* Nasal congestion,
* Post-nasal drainage.

Exclusion Criteria:

* Treatment with any systemic antibiotic within 30 days prior to enrollment
* Symptoms of sinusitis lasting for longer than 30 days;
* Four or more episodes of acute sinusitis within the preceding 12 months;

Primary outcomes:
measure: Patient reported symptom resolution at day 5
Secondary outcomes:
measure: Time to symptom resolution.
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01312220: Growth Factors and Hepatic Progenitor Cells in Acute Liver Failure
Official title: Relationship of Serological Growth Factors and Hepatic Progenitor Cells in Acute Liver Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: the Focus of the Study is to Correlate the Growth Factors in Serum With the Progenitor Cells in Liver
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute liver failure who received liver transplantation

Brief summary: To study the correlation of serological growth factors and the hepatic progenitor cells involved in liver regeneration of liver failure.


Eligibility criteria: Inclusion Criteria:

Acute liver failure Received iver transplantation

Exclusion Criteria:

Pregnancy Sepsis Heart failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: National Taiwan University Hospital
name: CM Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01157520: Study to Detect Hypotensive Episodes During Spinal Anesthesia for Cesarean Section Using a Noninvasive Continuous Device
Official title: Hypotensive Episodes During Cesarean Section Detected by a Continuous Non-invasive Arterial Pressure Measurement Device Are Missed by the Oscillometric Blood Pressure Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2010-07-07
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elective Cesarean section under spinal anesthesia

Brief summary: Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under five minutes after local anesthetics administration. These changes are poorly depicted by oscillometric measurements. The investigators hypothesized, that a continuous noninvasive device detects more hypotensive periods with lower blood pressures.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II
* week of pregnancy \>36

Exclusion Criteria:

* emergency cases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01814020: An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Distal Subungual Onychomycosis
Keywords: DSO
Lead sponsor: Moberg Pharma AB
Sponsor class: INDUSTRY
First posted: 2013-03-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT

Brief summary: Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with fungal nail infection.


Eligibility criteria: Inclusion Criteria:

1. Male or female
2. 18 - 70 years
3. DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail.
4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
5. Signed written informed consent

Exclusion Criteria:

1. Proximal subungual onychomycosis.
2. DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm)
3. "Spike" of onychomycosis extending to eponychium of the target nail
4. Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
5. Other conditions than DSO known to cause abnormal nail appearance
6. Topical antifungal treatment of the nails within 1 month before screening
7. Systemic use of antifungal treatment within 3 months before screening
8. History or signs of peripheral circulatory insufficiency and/or diabetic neuropathy
9. Immunosuppression
10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
11. Known allergy to any of the tested treatment products
12. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)
13. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who :

    * are pregnant or nursing
    * are not surgically sterile
    * are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner)

Primary outcomes:
measure: The proportion of patients with mycological cure of the target nail,defined as negative fungal culture and negative direct microscopy at 60 weeks.
timeFrame: At 60 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Hudkliniken Sahlgrenska Universitetssjukhuset
Study officials:
References:
Clinical trial NCT06804720: Self-Compassion Against Burnout in Dentistry
Official title: Self-Compassion as a Well-Being Strategy Against Occupational Burnout in Dentistry: A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Compassion
Mindfulness Meditation
Burn Out (Psychology)
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 49
Sex: ALL
Minimum age (years): 24
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although studies have highlighted the relationship between stress-related psychopathological symptoms and changes in biochemical parameters, no study in dentistry has concurrently evaluated the association of stress and relaxation with biochemical markers and psychological parameters. Moreover, the impact of mindfulness-based self-compassion training programs on these variables has yet to be explored within this context. To enhance the well-being of dentists, an evaluation of a test group participating in an 8-week Mindfulness-Based Compassionate Living (MBCL) program was conducted. This assessment included daily cortisol curves, as well as salivary IL-6, IL-1β, and oxytocin levels. Additionally, empathy, burnout, self-compassion, depression, and mindfulness levels were measured before and after the training. In this study, the main hypothesis was that, compared to the control group, the test group would exhibit lower IL-1β, IL-6, and cortisol levels, along with higher oxytocin levels. Furthermore, as the secondary hypotheses was that the test group would demonstrate increased empathy, self-compassion, and mindfulness levels, accompanied by reductions in depression and burnout scores.


Eligibility criteria: Inclusion Criteria:

* dentists in their final year of specialty training at the Faculty of Dentistry,
* systemicaly healthy

Exclusion Criteria:

* individuals who received a diagnosis of mood disorders based on DSM-5 criteria following a standard diagnostic assessment conducted by psychiatrists from the Department of Psychiatry

Primary outcomes:
measure: Self-Compassion Scale
timeFrame: Baseline and after 8 weeks
Secondary outcomes:
measure: Saliva Cortisol
timeFrame: Baseline and after 8 weeks
measure: Saliva IL 6
timeFrame: Baseline and after 8 weeks
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova UNiversity faculty of dentistry
state: Balcali
Study officials:
References: