louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00690690: No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks
Official title: No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV Infections
Keywords: HIV Seronegativity
HIV risk behavior
Unprotected sex
men who have sex with men
gay
Latino
unsafe sex
high risk sex
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Education Development Center, Inc.
name: Callen-Lorde Community Health Center
name: Hispanic AIDS Forum, Inc.
First posted: 2008-06-05
Enrollment: 370
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall goal of this study is to develop and evaluate a brief, video-based, group-level intervention designed to reduce sexual risk taking among culturally diverse English- and Spanish-speaking Latino men who have sex with men (MSM).


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18 - 49
* Self-identify as Latino or Hispanic
* Speak English and/or Spanish
* Reside in NYC and not plan to move in the next 3 months
* Have had 2 or more sex partners in the last 3 months
* Have had at least 1 male sex partner in the last 3 months
* Have engaged in unprotected anal intercourse with at least one male partner in the last 3 months
* Be HIV negative or not know their status

Exclusion Criteria:

* Participated in a program (research or non-research) during the past 6 months where they have received HIV prevention education (e.g. an in-person or online group session, workshop, support group).
* Report being HIV-positive

Primary outcomes:
measure: Sexual risk behavior
timeFrame: past 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York City
country: United States
facility: Education Development Center, Inc.
state: New York
Study officials:
affiliation: Education Development Center, Inc.
name: Lydia O'Donnell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03971890: Effectiveness of Dance Therapy in Fibromyalgia.
Official title: Effectiveness of a Exercise Program Based on Dance Therapy in Fibromyalgia: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Balance
Pain
TUG
Dance
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to analyze the effects of an intervention with dance on balance,movility, pain and sleep in patients with Fibromyalgia in comparison to a control group that will have an educational intervention.

Detailed description: Fibromyalgia is a chronic disease consisting of widespread pain, fatigue, sleep disturbances, and cognitive impairments, among other symptoms, which affect daily physical activity.

The regular physical exercise improves the functional, physiological, and behavioral components of physical fitness. Dance therapy seems to increase motivation and adherence to therapy, and can provide a real alternative to conventional exercise

The experimental group will receive a dance program treatment .

The control group will receive an educational intervention.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age until 64.
* Being diagnosed with FMS in accordance with American College of Rheumatology - ACR

Exclusion Criteria:

* Participants with diagnoses of other inflammatory rheumatic diseases, previous neurological or orthopedic diseases,
* Use aids for balance, hearing and visual problems.
* Cognitive impairment.

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: 8 weeks
Secondary outcomes:
measure: One leg stance
timeFrame: 8 weeks
measure: SLUMP Test
timeFrame: 8 weeks
measure: Straight Leg Raise test (SLR)
timeFrame: 8 weeks
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: 8 weeks
measure: Sheehan Disability Scale (SDS)
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks
measure: Athens Insomnia Scale (AIS)
timeFrame: 8 weeks
measure: Spanish version of the Brief Pain Inventory questionnaire (CBD)
timeFrame: 8 weeks
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: 8 weeks
measure: Epworth Sleepiness Scale, (EES)
timeFrame: 8 weeks
measure: Minibestest
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References:
Clinical trial NCT03540290: Treatment of Peri-implant Mucositis by Means of Implant Decontamination and Modification of the Implant Supported-prosthesis
Official title: Treatment of Peri-implant Mucositis by Means of Implant Decontamination and Modification of the Implant Supported-prosthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peri-implant Mucositis
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the modification of the implant prosthesis, in order to facilitate access to biofilm control, in combination with decontamination of the implant surface by means of an ultrasonic device with a plastic tip and plastic curettes, in comparison with the decontamination of the implant surface by means of an ultrasonic device with a plastic tip and plastic curettes, and no modification of the implant prosthesis.


Eligibility criteria: Inclusion Criteria:

* (1) Presence of, at least, one titanium implant exhibiting peri-implant mucositis, defined as bleeding on gentle probing (0.15 N) in at least one peri-implant site.

  (2) No signs of loss of supporting bone after initial bone remodelling. In cases where baseline radiograph is available, it will be used for comparison, otherwise a maximum of 2 mm of crestal bone loss will be accepted (5).

  (3) Single tooth and bridgework restoration with an inappropriate prosthesis design or contour which difficult oral hygiene access (overcontoured prosthesis, prostheses presenting closed embrasures, an abrupt emergence profile or excessive buccal flanges).

  (4) Presence of \>1 mm of keratinized peri-implant mucosa.

  (5) A good level of oral hygiene, defined as an O'Leary et al. plaque index \<25% (16).

  (6) Absence of systemic diseases that could influence the outcome of the therapy (i.e. controlled diabetes, with HbA1c\<7, patients will be included).

  (7) Non-smoker or light smoking status in smokers (\<10 cigarettes/day).

Exclusion Criteria:

* (1) Untreated periodontal conditions.

  (2) Pregnant or lactating women.

  (3) Patients who received systemic antibiotics in the last 3 months.

  (4) Patients who received treatment of PM in the past 3 months.

  (5) Patients receiving corticoids or medications known to have effect on gingival growth i.e. calcium channel antagonists, immunosuppressants or antiepileptic drugs.

In those cases diagnosed with peri-implantitis, individualized treatment will be provided, apart from the present study.

Primary outcomes:
measure: Evaluate modified sulcus Bleeding Index changes at 3 and 6 months, by the modification of the implant prosthesis in order to facilitate oral hygiene, hygiene instructions and surface decontamination
timeFrame: 1, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya
state: Sant Cugat Del Vallès
Study officials:
References:
Clinical trial NCT06751290: The Use of Cyproheptadine in Pediatric Feeding Disorders
Official title: The Use of Cyproheptadine to Improve Eating Habits in Children With Pediatric Feeding Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pediatric Feeding Disorder, Chronic
Avoidant Restrictive Food Intake Disorder
Keywords: Cyproheptadine
Malnutrition
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if Cyproheptadine, an appetite stimulant, can improve eating habits in children with Pediatric Feeding Disorders. Pediatric Feeding Disorders is a broad term that describes disorders of eating-related behaviors that causes altered consumption of food and impairs physical or psychosocial health.


Eligibility criteria: Inclusion Criteria:

* Any patient aged 2-6 years of age who presents to Pediatric Gastroenterology Clinic with complaint of "poor weight gain, malnutrition, failure to thrive/weight faltering, picky eating, or feeding issues" who screens positive for a pediatric feeding disorder using the Child eating disorder questionnaire (CEBQ)
* Age Range: 2-6 years
* English or Spanish speaking

Exclusion Criteria:

* Patients who are tube fed
* Patients who are overweight (BMI at 85th%tile or greater)
* Patients who have active symptoms from a diagnosis of a GI disorder (Inflammatory Bowel Disease, Eosinophilic Esophagitis, Gastritis)
* Patients actively undergoing behavioral feeding therapy

Primary outcomes:
measure: Change in Children's Eating Behavior Questionnaire score
timeFrame: Baseline and up to 6 months
measure: Number of foods consumed by participants
timeFrame: Baseline and up to 6 months
measure: Change in Child Food Neophobia score
timeFrame: Baseline and up to 6 months
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline and up to 6 months
measure: Change in height
timeFrame: Baseline and up to 6 months
measure: Change in BMI
timeFrame: Baseline and up to 6 months
measure: Change in BMI percentile
timeFrame: Baseline and up to 6 months
measure: Change in BMI Z-score
timeFrame: Baseline and up to 6 months
measure: Number of treatment related adverse events
timeFrame: Up to 6 months
measure: Parent's perception of medication's effects
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Department of Pediatric Gastroenterology
state: Florida
Study officials:
affiliation: University of Miami
name: Miguel Saps, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03351790: Endoscopy Quality Study
Official title: Assessing the Quality of Upper Gastrointestinal Endoscopy - Factors That Affect it and Validation of a Bespoke Mucosal Visual Scale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endoscopy
Lead sponsor: Sandwell & West Birmingham Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 250
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred for upper GI endoscopy (OGD)

Brief summary: This study seeks to establish factors that influence the view at endoscopy. To achieve this patients, who have been already booked for endoscopy, will complete a questionnaire prior to their procedure. Demographic and endoscopist factors will also be ascertained.

The view at endoscopy will then be reviewed and scored against a rating scale, which will be validated as a first phase of the study. Factors can then be sought that are associated with a good endoscopic view.


Eligibility criteria: Inclusion Criteria:

* Any patient booked for routine OGD

Exclusion Criteria:

* Inpatient endoscopy
* Barretts surveillance endoscopy

Primary outcomes:
measure: View seen at endoscopy
timeFrame: Endoscopy will be performed as booked for standard care. This will be the same day as consent.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02838290: Occupational Distress in Doctors: The Effect of an Induction Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Anxiety
Grief
Adaptation, Psychological
Eating Behavior
Alcohol Drinking
Drug Use
Keywords: Burnout
Psychiatric morbidity
Anxiety
Grief
Alcohol and drug use
Lead sponsor: Birkbeck, University of London
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 232
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: Over 39% of approximately 3,000 doctors (The British Medical Association quarterly survey, 2015) admitted to frequently feeling drained, exhausted, overloaded, tired, low and lacking energy. Such occupational distress may link to psychological and physical difficulties in doctors and have negative outcomes for organization and patients. The aim of the current study is to investigate the impact of an induction programme on occupational distress of doctors.

Methods/design: Doctors will be invited to take part in an online research. Participants will be randomly assigned to the experimental and control groups. Participants in the experimental groups will complete one of the induction topics (about stress at work). Before and after an induction programme participants will be asked to fill in an online survey about their current occupational distress and organizational well-being.

Discussion: The investigators expect that doctors' psychological, physiological and organizational well-being will improve after an induction programme which should serve as a resource for better doctor's own health understanding.


Eligibility criteria: Inclusion Criteria:

* Medical doctors across all specialties and professional grades who have a regular contact with patients and works in the United Kingdom.

Primary outcomes:
measure: The Anxiety Disorder Scale
timeFrame: A week
measure: The Grief Inventory
timeFrame: A week
measure: The Coping Mechanisms Scale
timeFrame: A week
measure: The Psychiatric Morbidity Scale
timeFrame: A week
measure: The Physical Symptoms Scale
timeFrame: A week
measure: The Insomnia Scale
timeFrame: A week
measure: The Binge Eating Scale
timeFrame: A week
measure: The Burnout Inventory
timeFrame: A week
measure: Alcohol use
timeFrame: A week
measure: Drug use
timeFrame: A week
Secondary outcomes:
measure: The Effort-Reward Scale
timeFrame: A week
measure: The Work Engagement Scale
timeFrame: A week
measure: The Work-Family Conflict Scale
timeFrame: A week
Other outcomes:
Locations:
Study officials:
References:
citation: Medisauskaite A, Kamau C. Does occupational distress raise the risk of alcohol use, binge-eating, ill health and sleep problems among medical doctors? A UK cross-sectional study. BMJ Open. 2019 May 15;9(5):e027362. doi: 10.1136/bmjopen-2018-027362.
citation: Medisauskaite A, Kamau C. Reducing burnout and anxiety among doctors: Randomized controlled trial. Psychiatry Res. 2019 Apr;274:383-390. doi: 10.1016/j.psychres.2019.02.075. Epub 2019 Mar 1.
Clinical trial NCT02747290: 68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
Official title: Safety and Diagnostic Performance of 68Gallium-labeled NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Keywords: BBN-RGD
PET
integrin αvβ3
GRPR
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2016-04-21
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed description: Both GRPR and integrin αvβ3 are overexpressed in neoplastic cells of human prostate cancer. To target both receptors, a heterodimeric peptide BBN-RGD was synthesized from bombesin(7-14) and c(RGDyK) through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-BBN-RGD and diagnostic performance of 68Ga-NOTA-BBN-RGD PET/CT in patients with primary and/or metastasis prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Must be able to provide a written informed consent, needle biopsy diagnosed as prostate cancer, have undergone whole body bone scan, able to provide basic information and sign the written informed consent.

Exclusion Criteria:

* The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.

Primary outcomes:
measure: Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events collection
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
name: Fang Li, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT03046290: Pudendal Block Versus Penian Block For Circumcision In Children
Official title: Pudendal Block Versus Penian Block For Circumcision In Children: A Double Blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regional Anesthesia
Postoperative Pain
Circumcision
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 60
Sex: MALE
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The authors study the efficacy of the pudendal versus penile block for the relief of postoperative pain in children receiving ambulatory circumcision.

In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited during the anesthesia consultation will be allocated a general anesthesia with a pudendal block (PUD group) or a penile block (PEN group).

Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).


Eligibility criteria: Inclusion Criteria:

* circumcision in day surgery hospital

Exclusion Criteria:

* allergy to amino-amide local anesthetics
* parental consent not received
* infection at injection site

Primary outcomes:
measure: postoperative pain score
timeFrame: pain score at 0 hours postoperatively
Secondary outcomes:
measure: Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview
timeFrame: Day 5 after the procedure
Other outcomes:
Locations:
city: Bruxelles Capitale
country: Belgium
facility: Hopital Erasme
Study officials:
References:
citation: Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25.
citation: Faraoni D, Gilbeau A, Lingier P, Barvais L, Engelman E, Hennart D. Does ultrasound guidance improve the efficacy of dorsal penile nerve block in children? Paediatr Anaesth. 2010 Oct;20(10):931-6. doi: 10.1111/j.1460-9592.2010.03405.x.
citation: O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x.
Clinical trial NCT05197790: Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device
Official title: A Single Center Study on the Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic Events
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to asses the function of an oxygen sensor and the movement sensor in a novel device prototype.

Detailed description: After informing the patient about the study and the potential risk. The patient is asked to wear a prototype of a novel device to sense oxygen levels and movement for the duration of the visit. The day of the enrolment is when the visit will be completed. The patient is required to complete an overnight sleep test (no more than 15 hrs) with the prototype device worn on their index finger and wrist.

Eligibility criteria: Inclusion Criteria:

* Males and Females
* 21 years of age or older
* Suspected to suffer from hypoxic events
* Able to provide informed consent

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Comparing Dove device against FDA approved SpO2 sensor
timeFrame: 15 hours
Secondary outcomes:
measure: Questionnaire about comfort of device
timeFrame: 15-20 minutes depending on the patients questions.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References: