louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03467191: Behavioral Alcohol Responses (BAR) Study
Official title: Predicting Alcohol Use and Alcohol Use Disorder Symptoms From Subjective Responses to Alcohol in a Laboratory Social Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Alcohol Drinking
Alcohol Use Disorder
Alcohol Intoxication
Alcohol; Harmful Use
Alcoholism
Binge Drinking
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: University of Pittsburgh
name: Penn State University
First posted: 2018-03-15
Enrollment: 782
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to identify risk factors that prospectively predict alcohol problems in young adults.

Detailed description: The vast majority of alcohol use takes place in social settings, yet nearly all human experimental work has administered alcohol to individuals in isolation. This study will examine the effects of alcohol in social groups and test whether these responses predict the escalation of alcohol use and development of alcohol use disorder symptoms. Participants will also complete smartphone surveys querying subjective responses to alcohol in their daily lives.

N=400 male and female young adults will participate in a laboratory session with two other participants and will consume either a moderate dose of alcohol or placebo beverage. Subjective and objective responses to alcohol will be assessed. Participants will also complete surveys on their smartphones; these will occur during drinking episodes and at random times throughout the day. Follow-up sessions will occur at 6-months and 12-months, to collect information about drinking habits and potential alcohol-related problems.

Eligibility criteria: Inclusion Criteria:

* 21 to 29 years of age
* currently drinks alcohol
* owns a smartphone

Exclusion Criteria:

\[Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.\]

Primary outcomes:
measure: Change from Baseline Alcohol Use at 12-months
timeFrame: 12-month follow-up
measure: Change from Baseline Alcohol Use Disorder Symptoms at 12-months
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Subjective Responses to Alcohol
timeFrame: 1 day (laboratory session) and 21-day ambulatory assessment period
measure: Social Bonding
timeFrame: 1 day (laboratory session)
measure: Social Bonding
timeFrame: 1 day (laboratory session)
measure: Mood
timeFrame: 1 day (laboratory session)
measure: Alcohol Use
timeFrame: 21-day ambulatory assessment period
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03068091: Assessment of Lung Movement With Computed Tomography (CT)
Official title: Assessment of Lung Movement With CT in Healthy Subjects and Patients With ILD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2017-03-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo CT and pulmonary function testing.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether patient with ILD have altered lung compliance on chest CT before they have macroscopic structural changes on CT.

Detailed description: Interstitial lung disease (ILD) is a group of lung disorders in which the lung tissues become inflamed and then damaged. Idiopathic Pulmonary Fibrosis (IPF) is one of the subtypes of ILD which has characteristic histological and CT features. It is well known that microscopic fibrosis occurs in the lungs of IPF patients well before the structural changes of fibrosis become apparent on CT. By combining sophisticated image analysis with CT scans obtained at full inspiration and full expiration, it may be possible to detect earlier changes of IPF than currently possible by looking at macro structural features alone. With the recent development of new therapeutics for IPF, early detection of the disease and improved monitoring of treatment efficacy will become important. Using CT to assess regional lung compliance has the potential to become an easily translated clinical tool.

Eligibility criteria: Inclusion Criteria:

* Subjects with ILD: Subjects must have a physician diagnosis of ILD and be in stable pulmonary condition at the time of the CT
* Healthy subjects: Subjects must have no history of pulmonary disease and smoked less than 100 cigarettes in their lifetime

Exclusion Criteria:

* Subjects less than 18 years of age

Primary outcomes:
measure: Lung Motion as Assessed by CT
timeFrame: Study visit 1 of a single visit study
Secondary outcomes:
measure: Lung Motion: Lobar Strain Which is a Ratio
timeFrame: Study visit 1 of a single visit study
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Talissa Altes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02611791: Radiofrequency Female External Genital Region: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dissatisfaction Appearance of the External Genitalia
Keywords: Treatment by Pulsed Radio Frequency, Collagen, Female
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the sexual function. METHODS: Single blind randomized controlled trial. Sample of 43 women (29 sexual active) with insatisfaction appearance of the external genitalia, 21 (14) in the study group and 22 (15) in the control group. The protocol consisted in 8 sessions of RF once a week. The instruments of evaluation were photo (taken before the first session and eight days after the last session), which were evaluated by the patient and by three health professional (that did not know the group); by the 3 points Likert scale (unsatisfied, unchanged, satisfied) and (worst, unchanged, improved). The sexual function was evaluated by the Female Sexual Function Index (FSFI) before and after, and analyzed by the T Test of Student. The patients' satisfaction and the health professionals' evaluation were analyzed by the chi-squared test and by binomial comparison inter-group and intra-group.


Eligibility criteria: Inclusion Criteria:

* were included women aged between 18 and 60 years with unsatisfied the appearance of the external genital, attending the clinical physiotherapy, Bahia, Brazil

Exclusion Criteria:

* Pregnant women, women that were using copper IUD, as well as other with skin lesions in the genital region were excluded from this trial.

Primary outcomes:
measure: clinical response
timeFrame: 2 months
measure: Patient satisfaction
timeFrame: 2 months
Secondary outcomes:
measure: Function Sexual
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Centro de Atenção ao Assoalho Pélvico - BAHIANA
name: Patricia V Lordelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00871091: Study Investigating Tooth Movements With Conventional and Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) Supported Fixed Appliances
Official title: Pilot Study Investigating Tooth Movements With Conventional and CAD/CAM Supported Fixed Appliances
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Movement
Orthodontics
Keywords: CAD/CAM
orthodontics
fixed appliance
tooth movement
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2009-03-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction.

May treatment be improved with customized archwires?

Study hypotheses:

* By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth movements can be avoided and teeth can be moved on their direct path to the intended position.
* The application of CAD/CAM improves reproducibility, efficiency, and quality of orthodontic treatment.


Eligibility criteria: Inclusion Criteria:

* treatment of front teeth with fixed orthodontic appliances is indicated
* complete secondary dentition
* age: 18-35
* in healthy general condition
* patient is informed about study and agrees to participate

Exclusion Criteria:

* treatment of premolars and molars is necessary
* syndromes affecting bones and teeth
* cleft lip and palate
* inflammation or reduction (more than 50%) of periodontium
* intake of drugs affecting tooth movement and bone formation
* disturbance of bone formation
* disturbance of thyroidal function
* pregnancy
* participation in additional study affecting oral hygiene
* former therapy with ionized radiation or cytostatic drugs
* caries (active phase)
* alcohol dependency

Primary outcomes:
measure: Sum of differences between resulted and shortest path of tooth movements in each patient
timeFrame: measurements every 14 days until end of treatment
Secondary outcomes:
measure: Difference between resulted and shortest path of movements for each tooth
timeFrame: measurements every 14 days until end of treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite - Universitätsmedizin
name: Paul-Georg Jost-Brinkmann, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT07009691: Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS
Official title: Heart Rate Variability as an Autonomic Marker of Improvement in ME/CFS in a Hydrogen Water Treatment Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Fatigue Syndrome
Keywords: Chronic fatigue syndrome; heart rate variability; treatment; hydrogen water.
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a study of hydrogen water as an intervention for ME/CFS that includes heart rate variability as a potential outcome marker of improvement/non-improvement.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if the OTC supplement, hydrogen water, works to treat the fatigue-related symptoms and functional limitations in adults with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). It will also examine if heart rate variability (HRV) can be used to predict who will benefit from the hydrogen water treatment. The main questions it aims to answer are:

Does the OTC supplement, hydrogen water, work to reduce the fatigue-related symptoms and improve functioning in participants who have ME/CFS?

Can HRV be used to predict who will benefit from treatment with hydrogen water?

Detailed description: The purpose of this pilot study is to identify a biomarker for improvement in chronic fatigue syndrome. Treatment of ME/CFS starting on 10-day graduated dosing schedule followed by a standard daily dose of hydrogen water (a magnesium-based OTC supplement) over 16 weeks is expected to yield two subgroups, improvers and non-improvers. These subgroups will be delineated by heart rate variability (HRV), a biological measure of health and well-being. Higher HRV will predict improvement and lower HRV will predict non-improvement (no change or worsening). This would be the first biomarker of improvement found in ME/CFS. If treatment is successful, subjects will experience a reduction in fatigue and an increase in physical function. Thus, the study may advance potentially an effective intervention for individuals with ME/CFS and further the understanding of the biology of favorable treatment outcomes, i.e., improved HRV status.

Eligibility criteria: Inclusion Criteria: Meets Institute of Medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome -

Exclusion Criteria: Medical illness that explains presenting fatigue; Any psychosis.

-

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Fred Friedberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03005691: Central Sensitization in Chronic Whiplash Patients
Official title: Central Sensitization in Chronic Whiplash Patients: Metabolite Concentrations in the Anterior Cingulate Cortex and Periacueductal Gray Matter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: metabolite
central sensitization
whiplash
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Hospital Nacional de Parapléjicos de Toledo
First posted: 2016-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have suffered whiplash syndrome. By one hand, patients with chronic pain (minimun 8 weeks) and 2 points or more of pain intensity. By the other hand, patiens without pain (2 points or less of pain intensity).

By last, subjects without whiplash syndrome.

Brief summary: The purpose of this study is to determine whether the metabolite concentrations within the anterior cingulate cortex and periaqueductal gray matter predict the intensity and interference of neuropathic pain after the development of chronic whiplash syndrome.

Detailed description: Persistent chronic pain is a common symptom of whiplash leading to reduced quality of life. Little information is available regarding changes in brain processing areas and change in central sensitization to noxious input during the chronic phase of whiplash. Metabolite concentrations in the anterior cingulate cortex and periaqueductal gray matter may be predictors of neuropathic pain and these changes may explain the development of central sensitization in people with chronic whiplash.

Until now, there is not any study that show this approach.

Eligibility criteria: Inclusion Criteria:

* Whiplash syndrome
* Chronic pain
* Age between 18 to 65 years
* 4 months to 2 years after the whiplash syndrome

Exclusion Criteria:

* Neurological disease
* Claustrophobia

Primary outcomes:
measure: Metabolite concentrations
timeFrame: Baseline at 0 min
measure: Conditioned Pain Modulation
timeFrame: Baseline at 0 min
measure: Brief Pain Inventory
timeFrame: Baseline at 0 min
measure: Neurophatic Pain Symptoms Inventory
timeFrame: Baseline at 0 min
measure: Pain Catastrophizing Helplessness Subscale
timeFrame: Baseline at 0 min
measure: Neck Disability Index
timeFrame: Baseline at 0 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Nacional de Parapléjicos, Toledo
name: Diego Serrano-Muñoz, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04956991: CT Diagnoses in Crohn"s Disease Activity
Official title: Applications of CT in Differentiating Crohn's Disease Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Crohn"s disease with complete CT and clinical data

Brief summary: The study focused on the clinical value of CT in assessing the activity of Crohn's disease.

Detailed description: "Crohn's disease is an inflammatory disease with non-specific clinical manifestations. The lesions are more common in the ileocecal area and the end of the ileum, and also can affect the entire digestive tract. In recent years, the domestic incidence of Crohn's disease has been increasing. At present, CT diagnosis still lacks the gold standard and requirescombination of clinical manifestations, endoscopic examination, imaging examination and laboratory examination results. CT has showed advantages of non-invasive inspection, fast imaging speed, high tissue density resolution, and strong patient acceptability. In addition, the examination can clearly show the internal and external tissue structure of the digestive tract, which has been widely used in the diagnosis and activity evaluation of Crohn's disease.

In order to clarify the clinical value of CT in assessing the activity of Crohn's disease, this study mainly used retrospective analysis of the CT manifestations and clinical data of patients with Crohn's disease to explore the clinical value of CT in assessing the activity of patients with Crohn's disease."

Eligibility criteria: Inclusion Criteria:

* Crohn's disease patients with confirmed endoscopic or pathological examination results
* Complete laboratory data such as CRP, erythrocyte sedimentation rate, etc.

Exclusion Criteria:

* Related inspection results are not complete
* The interval between endoscopic and laboratory examination results exceeds 2 months

Primary outcomes:
measure: Crohn's disease activity index (CDAI) scores
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Jianyu Liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT00544791: The Effect of Melatonin on Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment
Official title: The Effect of Melatonin on Memory and Other Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment (MCI): A Placebo- Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mild Cognitive Impairment (MCI)
Keywords: Mild Cognitive Impairment
Melatonin
Antioxidant
Memory
Alzheimer
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Neurim Pharmaceuticals Ltd.
First posted: 2007-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent studies have described the role of melatonin as a sleep regulator and as an anti- oxidative neuroprotective agent in improving sleep quality and delaying cognitive decline in Alzheimer's disease (AD).

In accordance with this data, our hypothesis is that melatonin will delay the cognitive decline in Mild Cognitive Impairment (MCI) patients and reduce the conversion rate from MCI to AD.


Eligibility criteria: Inclusion Criteria:

1. MCI assessment according to the Peterson et al. (2001) criteria.
2. Age 55-90 years, inclusive.
3. Study informant available.
4. Mini Mental Status Examination ; MMSE 24-30.
5. Adequate vision and hearing for neuropsychological testing.
6. Normal vitamin B12 level and thyroid function.

Exclusion Criteria:

1. Significant cerebral vascular disease (Modified Hachinski scale \> 4).
2. Depression (Hamilton Depression Rating Scale \> 12).
3. Central nervous system infarct, infection or focal lesions of clinical significance on CT or MRI scans.
4. Medical diseases or psychiatric disorders that could interfere with study participation.
5. Pregnant, lactating or childbearing potential.
6. Taking vitamin supplements or other supplements.
7. Restrictions on concomitant medication usage, including those with significant cholinergic or anti-cholinergic effects or potential adverse effects on cognition.

Primary outcomes:
measure: a delay in cognitive decline as measured by memory tests
timeFrame: 6 months
Secondary outcomes:
measure: Reduced MCI conversion rate to AD per year
timeFrame: Two years
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Memory clinic, 'Asaf Harofeh' medical center
Study officials:
affiliation: Assaf-Harofeh medical center, Memory clinic
name: Micheal khaigrekht, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf-Harofeh medical center, Neurology department
name: Martin Rabey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf-Harofeh medical center, sleep lab
name: Itzhak Sphirer, MD
role: STUDY_CHAIR
affiliation: Asaf Harofeh medical center, Memory clinic
name: Ran Shorer, MA
role: STUDY_CHAIR
References:
Clinical trial NCT02265991: Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation
Official title: Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation in 27 Consecutive Cases: a Clinical Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with informed consent and that will undergo mandible resection and reconstruction via free fibula flap at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.

Brief summary: Pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities.

Detailed description: 27 patients are examined before and after microsurgical fibula flap performed at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.

Eligibility criteria: Inclusion Criteria:

* Planned continuity interrupting mandible resection
* Planned mandible reconstruction with free fibula flap
* Informed consent
* Procedure performed at University Medical Center Hamburg Eppendorf

Exclusion Criteria:

* Preexisting pathology/disease of the lower limbs or back (angiologic, neurologic, orthopedic)
* Musculosceletal pain at the time of study enrollment

Primary outcomes:
measure: Change in Esslinger Fitness Index
timeFrame: 1 day before fibula transplantation and 8.3 months postoperatively on average
Secondary outcomes:
measure: AOFAS Score
timeFrame: 1 day before fibula transplantation and 8.3 months postoperatively on average
measure: Balance Test
timeFrame: 1 day before fibula transplantation and 8.3 months postoperatively on average
measure: Range of Motion
timeFrame: 1 day before fibula transplantation and 8.3 months postoperatively on average
Other outcomes:
Locations:
Study officials:
References: