louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04779801: Attachment-Based Family Therapy for Adolescents With Binge Eating
Official title: Attachment-Based Family Therapy for Adolescents With Transdiagnostic Binge Eating
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bulimia Nervosa
Binge-Eating Disorder
Other Specified Feeding or Eating Disorder
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether Attachment-Based Family Therapy (ABFT), a well-validated treatment for adolescents with depression and suicidality, is feasible and acceptable for adolescents with binge eating and their families.

Detailed description: This study involves a phone screen and baseline assessment to determine eligibility. Participants who are eligible for the study will receive 16 weeks of ABFT treatment. The treatment primarily focuses on improving communication and relationships within the family, and will also address disordered eating behaviors (e.g., binge eating, laxative use, self-induced vomiting). All participants enrolled in the study will receive the same treatment. Participants will also complete research assessments throughout treatment, at the end of treatment, and 3-months after the end of treatment. Research assessments include a battery of questionnaires and interviews.

Eligibility criteria: Inclusion Criteria:

* Speak, write, and understand English
* Age 12-22 years old
* Have a diagnosis of DSM-5 AN, BN, BED, or OSFED
* Medically stable for outpatient treatment
* Must have a parent, guardian, or primary caregiver who is willing to participate in the study and treatment

Exclusion Criteria:

* Acute suicide risk
* No parent or guardian agreement to participate
* Are currently receiving psychological treatment for an eating disorder
* Are currently receiving weight loss treatment
* Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
* Diagnosis of intellectual disability

Primary outcomes:
measure: Five-Minute Speech Sample (FMSS)
timeFrame: Change in critical comments and emotional overinvolvement from baseline to treatment completion, at 16 weeks
Secondary outcomes:
measure: Eating Disorder Examination (EDE)
timeFrame: Change in frequency of binge-eating and, if applicable, purging from baseline to treatment completion, at 16 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03288701: Smart SCALEs With Bioimpedance Analysis for Treatment Guidance in Decompensated Heart Failure
Official title: SCALE HF - Smart SCALEs With Bioelectrical Impedance Analysis for Treatment Guidance in Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure; With Decompensation
Keywords: heart failure
cardial decompensation
smart scale
bioimpedance analysis
whole body water
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this trial the measurement of whole body water will be compared to the standard method of measuring the body weight as treatment guidance in patients with decompensated heart failure. The Seca mBCA 515 \[medical Body Composition Analyser\] will be used to quantify the whole body water by using bioelectrical impedance analysis.

Detailed description: Investigators will include 153 participants hospitalized in the University Hospital in Basel. Daily measurements of whole body water and body weight will be performed in each person until diuretic treatment is stopped or the patient is discharged from hospital, respectively.

Primary endpoint is the correlation between reduction of whole body water (in kg) and reduction of body weight (in kg) in patients with decompensated heart failure receiving forced diuretic treatment (max. deviation +/- 1kg).

Eligibility criteria: Inclusion Criteria:

* able to give informed consent
* hospitalization because of decompensated heart failure treated with forced diuresis
* able to stand on the scale without help from others and able to hold handrails with both hands

Exclusion Criteria:

* refusal to share personal data
* implantable electronic device (e.g. Pacemaker, etc.)
* condition that does not allow skin contact of soles of feet and scale or hands with handrail (leg prosthesis, wounds, bandage, etc.)

Primary outcomes:
measure: Measurement of total body water (TBW) in kg
timeFrame: From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.
measure: Measurement of body weight (BW) in kg
timeFrame: From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.
Secondary outcomes:
measure: Measurement of fatty tissue (FT) in kg
timeFrame: From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jens Eckstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06354101: The Purpose of This Registry Study is to Learn More About Metabolic Health: Approximately 15,000 Participants Who Are Overweight or Have Obesity With or Without Metabolic Diseases Are Expected to Participate in This Registry Study.
Official title: The VITALITY Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Metabolic Health
Lead sponsor: CorEvitas
Sponsor class: NETWORK
Collaborators: name: Eli Lilly and Company
First posted: 2024-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective, observational registry to study metabolic health in individuals.

Brief summary: The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study.

Detailed description: The VITALITY Registry is a research study to collect healthcare information on people with conditions related to their weight which is stored in a database. Participants, along with their doctor, provide the health information that makes up this database. Participants will not be asked to take any special treatments or tests as part of the study.

Participants will be asked to complete questionnaires 2 times a year for up to 10 years, and the doctor will be asked to enter certain available information from office visits 1 time per year for up to 10 years regarding health, treatments, and symptoms related to the participants metabolic health.

The information that will be collected for this study will include demographics (for example, age, gender, race, employment, etc.), medical history (including all prior and current treatments), social history, details about your metabolic health, how metabolic health impacts daily life, mental health, and satisfaction with treatment.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age (or age of majority)
* Willing to provide consent to participate

Exclusion Criteria:

-

Primary outcomes:
measure: Main Objective of Registry
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05778201: To Study the Effects of Baby Drink on Vision Care
Official title: To Study the Effects of Baby Drink on Vision Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Myopia
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Baby Drink Intervention group
Primary purpose: PREVENTION

Brief summary: Baby Drink is a formula based on lutein, mixed with blueberry fermented liquid, vitamins and minerals. Lutein is an effective antioxidant to prevent retinal damage caused by blue light, but it cannot be produced in the human body and depends on dietary intake. Blueberry fermented liquid is rich in polyphenolic compounds with excellent antioxidant capacity and the potential to reduce oxidative damage to eye cells caused by ultraviolet rays. With the prevalence of 3C products, myopia patients are increasing year by year in various regions, and suffer from eye diseases or vision loss with different degrees of complications. In this study, the subjects were provided with Baby Drink and tracked the degree of visual fatigue by regular questionnaires, and measured for visual acuity, axial length and diopter. The aim of this study is to investigate the protection of Baby Drink on visual acuity and visual fatigue.

Detailed description: 1. Visual acuity measurement: Snellen's Chart was used to measure visual acuity.
2. Refractive examination: Measure binocular refraction with Open Field computer refractor (Shin-Nippon Nvision K5001 Wide View).
3. Measuring the axial length of the eye: Use the multifunctional optical eyeball length measuring instrument (Lenstar) to measure the distance from the instrument to the optical paths such as the cornea, lens, and retina, and then convert to the axial length of the eye.
4. Corneal radian measurement: Use a keratometer (Bausch \& Lomb Keratometer) to measure the corneal radian and curvature, and estimate the degree of corneal astigmatism.
5. Visual fatigue questionnaire survey: A visual fatigue scale questionnaire was designed using Ocular Surface Disease Index (OSDI) and Computer Vision Syndrome (CVS).

Eligibility criteria: Inclusion Criteria:

1. Adults aged 20 or over
2. Willing to participate in this study and sign the subject's consent form
3. Myopia less than 700 degrees

Exclusion Criteria:

1. Have consumed related eye care products in past 3 months
2. Those who have eye infection in the past 3 months
3. People who have been diagnosed with any eye diseases in past 3 months
4. Those who are allergic to cicadae

Primary outcomes:
measure: Eye fatigue questionnaire
timeFrame: 1 month
measure: Best vision test
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia university
Study officials:
affiliation: Asia University
name: Hui Wen Lin, ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01250301: De-nicotinised Cigarettes Study
Official title: Complementing Current NHS Stop Smoking Service Treatments for Smokers With Behavioural Replacement: The Role of De-nicotinised Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Tobacco Dependence
Keywords: Smoking Cessation
Tobacco Dependence
De-nicotinised cigarettes
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-11-30
Enrollment: 200
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 aim of this study is to determine if using a behavioural replacement for smoking (de-nicotinised cigarettes; DNCs), in addition to standard treatment during the first two weeks after the target quit date, can reduce urges to smoke over the first 4-weeks of abstinence. Two hundred smokers who want to quit will be recruited from the community. They would all receive standard smoking cessation treatment from the NHS Stop Smoking Service (NHS SSS), which uses a combination of stop smoking medication (e.g. nicotine replacement therapy, Champix) and motivational support. On their target quit date, participants would be randomised to receive behavioural replacement ( i.e. use of de-nicotinised cigarettes) plus standard treatment for the first two weeks of their quit attempt, or to continue with standard treatment alone. De-nicotinised cigarettes are similar to standard cigarettes except that they do not deliver nicotine to the smoker. Participants will rate their urges to smoke at each week. Standard NHS SSS measures will also be taken in addition to user acceptability ratings and reactions to smoking cues.

The hypothesis is that complementing current NHS SSS treatments with de-nicotinised cigarettes, to address the non-nicotine factors associated with smoking and to help extinguish smoking behaviour, would result in lower urges to smoke than standard treatment alone.


Eligibility criteria: Inclusion Criteria:

* 18 years or over
* Seeking treatment to stop smoking

Exclusion Criteria:

* Pregnant or breastfeeding
* Acute psychiatric illness

Primary outcomes:
measure: Urges to smoke in first week of abstinence
timeFrame: 1 week
Secondary outcomes:
measure: Change in ratings of tobacco withdrawal symptoms, measured by the MPSS
timeFrame: First 4 weeks of abstinence (from baseline- 4 weeks post-quit)
measure: CO-validated continuous abstinence rates
timeFrame: 4-weeks
measure: Acceptability and user reactions to DNCs
timeFrame: 2 weeks
measure: Urges to smoke 24 hours after quitting, measured by the MPSS
timeFrame: 24 hours
measure: Profile of adverse effects up to 12 weeks post quitting
timeFrame: 12 weeks
measure: Reactions to smoking cues
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Tobacco Dependence Research Unit
Study officials:
affiliation: Queen Mary University of London
name: Hayden McRobbie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01867801: Portuguese Registry on Interventional Cardiology
Official title: Portuguese Registry on Interventional Cardiology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: PCI
Coronary disease
Ischemia
Lead sponsor: Portuguese Society of Cardiology
Sponsor class: OTHER
Collaborators: name: Portuguese Association of Interventional Cardiology
First posted: 2013-06-04
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients admitted to Portuguese hospitals for percutaneous coronary intervention

Brief summary: The purpose of this Registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of clinical and interventional practice recommendations for diagnosis and treatment of coronary disease and monitoring its evolution.

Detailed description: Cardiovascular disease remains the main cause of death in Portugal and approximately one quarter of these are directly to ischemic heart disease. In order to better characterize percutaneous coronary intervention in Portugal, the Portuguese Society of Cardiology has promoted the Portuguese registry on percutaneous coronary intervention.

This will include all adult patients (≥ 18 years), eligible for percutaneous coronary intervention (PCI) in accordance with PCI state-of-art recommendations (including unstable and stable coronary disease). The Cardiology department where the patient has been hospitalized is responsible for the patient inclusion in the study.

Excluded patients are those in whom the preferred treatment is Coronary Artery Bypass Graft (CABG), age under 18 years or life expectancy of less than 12 months.

Eligibility criteria: Inclusion Criteria:

1. Patients with:

   * stable angina or,
   * stabilized angina pectoris or,
   * atypical chest pain or,
   * no chest pain but with documented silent ischemia
2. At least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
3. Eligible for PCI
4. Informed consent

Exclusion Criteria:

1. Patients in whom the preferred treatment is CABG;
2. Contra-indication to dual antiplatelet therapy
3. Coronary artery disease precluding PCI
4. A life expectancy of less than 1 year
5. Age under 21

Primary outcomes:
measure: Major adverse cardiac event rate (MACE) MACE: A composite of all cause death, documented Myocardial Infarction (MI), unplanned hospitalization leading to urgent revascularization.
timeFrame: 24 months
Secondary outcomes:
measure: Total mortality
timeFrame: 12 month
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: CNCDC
Study officials:
affiliation: Portuguese Society of Cardiology
name: Marco Costa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189501: A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)
Official title: A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrology
Keywords: Chronic Kidney Disease, CKD,
Secondary Hyperparathyroidism, HPT
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Objectives include description of current practices; assessment over time of K/DOQI goals, clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and the impact of Sensipar® on these parameters


Eligibility criteria: Inclusion Criteria:

* 3 month history of Stage 4 or Stage 5 CKD
* A PTH value within 3 months of enrollment
* If relevant, completion of Sensipar® study prior to enrolling in Registry Exclusion Criteria:
* Females who are pregnant or breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05399901: M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions (PerineUM)
Official title: Use of Transabdominal M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Disorders
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 60
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: Objectives: To analyze the Mode M ultrasound use in the assessment of pelvic floor musculature (PFM) and in the rehabilitation of motor control in pelviperineal dysfunctions that affect the support of pelvic organs, urinary and fecal continence and reproductive and sexual functions.

Methodology: A cross-sectional descriptive study will be followed by a randomized clinical trial. There will be two samples: a sample of volunteers without PFM dysfunction; and a sample of patients with pelviperineal dysfunction derived from health centers in the Region of Murcia. An intra- and interobserver reliability study of transabdominal M-mode ultrasound of PFM will be performed. Then, a cross-sectional descriptive study of the functional behavior of PFM will be used in different functional situations such as: voluntary contraction at maximum force, fast contraction, Valsalva maneuver and forced cough. The following ultrasound variables will be measured: direction and amount of displacement, speed of displacement and time of contraction. Correlations between ultrasound variables and sociodemographic and clinical variables will be analyzed. The randomized clinical trial will compare a PFM contraction awareness treatment based on endocavitary digital contact with a motor learning program based on transabdominal mode M ultrasound biofeedback.


Eligibility criteria: Inclusion Criteria:

* Patients with pelvic floor dysfunction derived from the pelvic floor unit of HLA La Vega in the city of Murcia diagnosed by the doctor and without previous training in pelvic floor muscles contraction.

Exclusion Criteria:

* Pregnancy, a history of pelvic floor surgery in the previous year, neurological injury with affectation of the sacral reflex from S2 to S4, previous delivery in a period of less than 6 weeks or known or suspected urinary tract infection.

Primary outcomes:
measure: Changes in the self efficacy expectations in performing pelvic floor exercises.
timeFrame: At baseline and after the intervention (1 week from baseline)
measure: Changes in the outcome expectations for pelvic-floor exercise treatment.
timeFrame: At baseline and after the intervention (1 week from baseline)
Secondary outcomes:
measure: Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor.
timeFrame: At baseline and after the intervention (1 hour from baseline)
Other outcomes:
Locations:
Study officials:
affiliation: Murcia University
name: MARIA ELENA DEL BAÑO ALEDO, PhD
role: PRINCIPAL_INVESTIGATOR
References: