louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00699556: Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Official title: Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Drinking
Keywords: alcohol
nicotine
smoking cessation
smoking cessation medications
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2008-06-18
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.


Eligibility criteria: Inclusion Criteria:

* Ages 21 and over
* Able to read and write in English
* Smoker
* Heavy drinker

Exclusion Criteria:

* Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol or nicotine
* Significant hepatocellular injury
* Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* Women who are pregnant or nursing
* Suicidal, homicidal, or evidence of severe mental illness
* Prescription of any psychotropic drug in the 30 days prior to study enrollment
* Blood donation within the past 8 weeks
* Individuals who are seeking treatment for drinking or smoking who have attempted to quit drinking or smoking within the past 3 months
* Specific exclusions for administration of nicotine nasal spray not specified above including nasal polyps, chronic nasal congestion, allergies, sinusitis
* Specific exclusions for administration of nicotine patch not specified above including history of dermatoses
* Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior adverse reaction to nicotine spray
* Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study

Primary outcomes:
measure: Number of Drinks Consumed During an Ad-libitum Drinking Period
timeFrame: Two hour ad-libitum drinking period during laboratory session
Secondary outcomes:
measure: Craving for Alcohol
timeFrame: first measurement during laboratory session (+60 minutes after beginning of laboratory session)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center & Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Sherry A McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06879756: Relationship Between Flexible Flat Foot and Lumbar Proprioception
Official title: Relationship Between Flexible Flat Foot and Lumbar Proprioception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flexible Flatfoot
Lumbar Spine Injury
Proprioceptive Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 57
Sex: ALL
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: • Subjects with flexible flat foot posture according to the Navicular Drop Test by Brody method: a normal foot (between five and nine mm of navicular drop), apronated foot (more than 10 mm of navicular drop).

Brief summary: The purpose of this study was to determine the relationship between flexible flatfoot and lumbar proprioception.

Detailed description: The human foot plays a crucial role in maintaining balance during various activities, and poor foot alignment, such as excessive subtalar joint pronation, can lead to leg, knee, and back pain. Proprioception is essential for active joint stability, as it indirectly modulates and provides motor response, helping the neuromuscular system maintain balance. Lumbar proprioception deficits can decrease the ability to assume a neutral spinal posture and coordinate muscle contraction, affecting spinal segmental function, dynamic joint stability, and good motor control. This study investigates the association between flatfoot and lumbar proprioception.

Eligibility criteria: Inclusion Criteria:

* 60 subjects of both sexes (females and males) were selected and assigned into two groups
* Patient's age range was between 17 to 30 years old.
* Subjects with flexible flat foot posture according to the Navicular Drop Test by Brody method: a normal foot (between five and nine mm of navicular drop), pronated foot (more than 10 mm of navicular drop).
* Patients will be willing and able to participate in assessment without cognitive impairments that would limit their participation

Exclusion Criteria:

The potential participation was excluded when they had one of the following criteria:

* Repeated lower extremity injuries, such as fractures or deformities.
* History of surgery to the lower extremity.
* history of back surgery
* rheumatologic disorders
* spine infections
* ankle fracture
* lumbar fracture
* spondylosis
* lumbar disc bulge
* spondylolisthesis

Primary outcomes:
measure: assessment of the foot posture using navicular drop test
timeFrame: at baseline
Secondary outcomes:
measure: assessment of change of lumbar proprioception using Biodex system isokinetic dynamometer
timeFrame: at baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: out-patient clinic, faculty of physical therapy, Cairo university
Study officials:
References:
Clinical trial NCT03031756: Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis
Official title: Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Halitosis
Keywords: Air polishing
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this clinical study was to evaluate the clinical efficacy of using perio flow adjunctively with mechanical instrumentation on periodontal parameters and halitosis.

Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur compound (VSC) values were measured by a halimeter at the baseline, immediately after treatment, and at 7 days, 14 days and 1 month.


Eligibility criteria: Inclusion Criteria:

* In the present trial, patients who had at least three teeth with 4-6-mm periodontal pockets.

Exclusion Criteria:

* acute infectious oral lesions,
* furcation defects,
* using antibiotics for any reason in the last 4 weeks,
* periodontal treatment in the last 6 months and
* pregnant or lactating patients.

Primary outcomes:
measure: Periodontal Pocket Depth (PPD)
timeFrame: 30 day.
Secondary outcomes:
measure: halimeter values.
timeFrame: 30 day.
Other outcomes:
Locations:
Study officials:
affiliation: Near East University, Faculty of Dentistry
name: Hasan Guney YILMAZ, DDS,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02555956: Grid Laser for Diffuse Diabetic Maculopathy
Official title: Subthreshold Double Frequency Nd. YAG Grid Laser for Diffuse Diabetic Maculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Keywords: Macular grid
Subthreshold
diabetic macular edema
decrease in visual acuity
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients having diffuse diabetic macular edema.

Brief summary: Diabetic related complications are increasing day by day due to increse in the number of diabetic patients all over the world. Diabetic macular edema is one of them and a major cause of vision imparment. Various kind of treatment modalities are preent to treat this coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive procedure.Laser power if kept to aminimum can get the desired results without severe destruction to the retina . In this study, the investigators are going to document the effect of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with macular edema.
* both sexes
* conset to participate.

Exclusion Criteria:

* focal edema.
* patients requiring only the focal laser.
* patients with proferative diabetic retinopathy.
* Patients with ischaemic maculopathy on fundus fluorescein angiography.

Primary outcomes:
measure: Improvement of visual acuity after grid laser
timeFrame: 6 week
Secondary outcomes:
measure: Complication
timeFrame: during first six weeks after laser
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow universty Hospital,Dow international Medical college
state: Sindh
Study officials:
affiliation: Dow university of health sciences, karachi
name: Dr. Jamshed Ahmed, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences
name: Jamshed Ahmed, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00583856: Computer Modeling With Reconstruction of Maxillofacial Skeleton
Official title: Is Computer Modeling and Intra-Operative Navigation Helpful With Reconstruction of the Maxillofacial Skeleton?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillofacial Injury
Keywords: computer aided design
maxillofacial fracture
orbital design
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 3
Sex: ALL
Minimum age (years): 11
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: UCDMC Patients with specific complex fractures

Brief summary: Investigator initial study to evaluate the use of preoperative computer modeling and the intraoperative navigation to guide reconstruction of the maxillofacial skeleton.

Detailed description: The concept of open reduction and internal fixation of facial fractures is well accepted. However, there are situations in which an accurate reduction and restoration of facial symmetry is challenging. In these more difficult cases, the PI uses computer aided design/modeling software as well as intra-operative computer aided surgical navigation systems to assist with repair of these complex injuries. A retrospective review of these cases has not previously been performed.

Eligibility criteria: Inclusion Criteria:

* specific complex maxillofacial trauma

Exclusion Criteria:

* must meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Edward B Strong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03741556: Prognostic Factors Following Ankle Fractures
Official title: Recovery Following Ankle Fracture Reported by Patient Report Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Fractures
Lead sponsor: Sygehus Lillebaelt
Sponsor class: OTHER
Collaborators: name: Kolding Sygehus
First posted: 2018-11-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with an ankle fracture, treated either with an operation or non-operative in one of three hospitals

Brief summary: Ankel fractures is a common fracture. Most patients experience that the regain normal range of motions and limited pain within the first 6 months following ankel fracture, but not all. The aim of the study is to determine if any prognostic factors is associated with a worse outcome.

Detailed description: Aim of study:

To identify prognostic factors associated with a worse outcome following ankle fractures.

Method:

All operated or non-operated ankle fractures in a period of one year from three different hospitals will be included. The following data will be recorded:

Civil registration number, age, rupture of the syndesmosis, use of alcohol, smoking, diabetes, characteristics of the ankle fracture (AO classification), type of treatment and complications.

Study participants will at time of diagnosis and 6, 12, 52 and 104 weeks following the injury received a questionaire with Manchester foot and ankle questionnaire (MOXFQ), Self-reported foot and ankle questionnaire (SEFAS), Olerud Molander Ankle Score (OMAS) and Forgotten Joint Score (FJS).

Which of the questionaire that should be used in the study will be determined when the questionaires have been compared in a different study.

Eligibility criteria: Inclusion Criteria:

* All patients with ankle fracture.

Exclusion Criteria:

* age below 18 years
* patients who do not speak or understand danish
* mental disable patients

Primary outcomes:
measure: Manchester foot and ankle questionnaire (MOXFQ)
timeFrame: 2 years
measure: Self-reported foot and ankle questionnaire (SEFAS)
timeFrame: 2 years
measure: Olerud Molander Ankle Score (OMAS)
timeFrame: 2 years
measure: Forgotten Joint Score (FJS)
timeFrame: 2 years
Secondary outcomes:
measure: EQ5D-3L
timeFrame: 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Amager Hvidovre Hospital
city: Kolding
country: Denmark
facility: Sygehus Lillebaelt
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT02220556: Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology
Official title: Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor.
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral type. Up to 50 patient can be included into each cohort.


Eligibility criteria: Inclusion Criteria:

* 18 years old or more
* Performance status from 0 to 4
* Patient treated followed for histologically confirmed solid tumor type of any of these localization : breast, prostate, uterus, ovary, colon, lung, head and neck, melanoma.
* Informed consent form signed.

Exclusion Criteria:

* Patient with history of other invasive cancer within 5 years.
* Patient treated for any non-invasive cancer
* Patient individually deprived of liberty or placed under the authority of a tutor
* Geographical condition potentially preventing compliance with the study protocol.

Primary outcomes:
measure: CTC, CEC or ctDNA incidence
timeFrame: 3 years
Secondary outcomes:
measure: CTC and CEC molecular characterization
timeFrame: 3 years
measure: Circulating tumor DNA (ctDNA) detection and quantification
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Saint-Cloud
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Jean-Yves Pierga, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Curie
name: François-Clément Bidard, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06942156: Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea
Official title: A Prospective, Multicenter, Open-Label, Randomized, Comparative, Phase 4 Trial to Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Heart Transplant
Keywords: Heart transplant
Everolimus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2025-04-24
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of lower dose calcineurin inhibitors (CNI) in combination with Everolimus in Korean heart transplant recipients.

Detailed description: This study is a prospective, multicenter, open-label, randomized, comparative, phase 4 trial to optimize immunosuppressive therapy using everolimus and low-dose calcineurin inhibitors in heart transplant patients in Korea.

Eligibility criteria: Inclusion Criteria:

1. Over 19 years old
2. Patients with stable heart transplant graft function at least 28\~100 days post transplant.
3. Patients who are appropriate for combination therapy with Everolimus and Calcineurin inhibitor (CNI) at the investigator's discretion

Exclusion Criteria:

1. Recipients who have had a prior organ transplant, or who underwent a heart transplant with the simultaneous transplantation of another organ.
2. Recipients of heart from ABO-incompatible donor
3. Recipients of heart from the donor aged 70 or older

Primary outcomes:
measure: hierarchical composite assessed using the win-ratio
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Graft rejection
timeFrame: Baseline and 6, 12 months after drug administrations
measure: Newly developed Graft dysfunction
timeFrame: Baseline and 6, 12 months after drug administrations
measure: Change in renal function
timeFrame: Baseline and 6, 12 months after drug administrations
measure: CAV ISHLT grade
timeFrame: Until 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jin-O Choi, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02042456: Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
Official title: Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: breast cancer
dense breasts
mammography screening
Screening techniques
women
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from the patients arriving at the clinic for yearly breast cancer screening exams

Brief summary: This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis


Eligibility criteria: Inclusion Criteria:

* Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
* Women aged ≥18 years at the time of enrollment;\*
* Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
* At moderately increased or high risk (\>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:

AND Referred for screening mammography

Exclusion Criteria:

* Have been screened using any breast imaging technology in \<12 months immediately prior to enrollment;
* Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
* Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
* Are currently pregnant as determined per standard clinical practice at the investigational site;
* Present with contraindications to any imaging examination required in the study protocol;
* Have breast implants; OR
* Are lactating.

Primary outcomes:
measure: Abnormal interpretation rate
timeFrame: One Year
Secondary outcomes:
measure: Sensitivity
timeFrame: One Year
measure: Specificity
timeFrame: One Year
measure: Cancer Rate
timeFrame: One Year
measure: Positive Predictive Value
timeFrame: One Year
measure: Negative Predictive Value
timeFrame: One Year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Seattle Cancer Care Alliance
state: Washington
Study officials:
References: