louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01237938: Effect of a Low Glycemic Index Diet on Breast Density
Official title: Pilot Study of the Effect of a Low Glycemic Index Diet on Breast Density (Diet and Breast Health Study )
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 46
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer.


Eligibility criteria: Inclusion Criteria:

* Are between 40 and 60 years of age
* Still menstruating with at least 10 menstrual cycles in the previous 12 months
* Not Taking hormone replacement therapy
* Stable oral contraceptive use (no changes is use in past 12 months nor changes intended during interventional period)
* Have not been previously diagnosed with breast cancer, DCIS,lobular carcinoma in situ, atypical lobular hyperplasia or atypical hyperplasia
* No history of breast augmentation or reduction surgery
* Have no history of any other malignancy (excluding non-melanoma skin cancer) in the previous 5 years
* Have no history of diabetes or other metabolic diseases requiring dietary modification
* Have a study baseline mammographic density of at least 50% as estimated by mammographer
* BIRADS 1 or 2 mammogram if first ever mammogram, otherwise stable mammogram (no change since previous year)
* Have not followed a weight reduction or Atkins typs diet in the past 6 months Not pregnant or lactating in the past 12 months, nor intending pregnancy during the study period
* Successful completion of three baseline telephone-administered 24- hour dietary recalls

Primary outcomes:
measure: Diet Change
timeFrame: 2 years
Secondary outcomes:
measure: Biomarkers
timeFrame: 4, 8 & 12 months on Treatment
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Susan McCann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02522143: College Students Who Self-Harm
Official title: College Students Who Self-Harm: An Intervention Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Borderline Personality Disorder
Suicide
Keywords: self-harm
self-mutilation
cutting
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Aims/Objectives:

This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to the unique requirements of students meeting sub-clinical diagnostic criteria for BPD (Borderline Personality Disorder) with its associated high rate of self-harm and suicide.

Detailed description: Study Aims/Objectives:

This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to the unique requirements of students meeting sub-clinical diagnostic criteria for BPD with its associated high rate of self-harm and suicide. The investigator previously implemented a 4-mth condensed-DBT regimen with success in an adult clinical population. This study will evaluate an intensive 8 week intervention formulated for students to reduce the high prevalence of self-harm and dysfunctional behavior in this population and reduce the need for extended treatment in later years. It will include rigorous screening for collateral disorders, including Substance Use Disorders exacerbating BPD symptoms and suicide risk.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 27
* Currently enrolled in college
* Meet at least 4 of 9 Criteria of BPD (DSM-V) with one criterion being self-harm (e.g. cut, burn, or hit self)

Exclusion Criteria:

* have a current major psychiatric disorder diagnosis, or other gross cognitive impairment (as identified in the phone screen or the SCID I measure) or
* have undergone DBT or
* are suicidal and require full DBT and/or hospitalization or
* are currently in any other individual or group therapy
* unable to attend weekly visits over 8 weeks, starting March 24, 2014

Primary outcomes:
measure: Change in BPD (Borderline Personality Disorder) behaviors
timeFrame: 8-weeks
Secondary outcomes:
measure: Change in reported psychiatric symptoms,
timeFrame: 8-weeks
measure: Diminished emergency room visits
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: CTSI
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Richelle N Moen,, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Clinical trial NCT06706843: The Effect of Transtheoretical Model-based Motivational Interview on Self-efficacy and Illness Compliance
Official title: The Effect of Transtheoretical Model-based Motivational Interview on Self-efficacy and Illness Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Units, Hospital
Lead sponsor: Şırnak Üniversitesi
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Transtheoretical Model Based Motivational interview was conducted.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: This study was planned to determine the effect of transtheoretical model-based motivational interviewing on patients\&#39; self-efficacy and disease adherence in patients receiving haemodialysis treatment.

Study design and methods: This study was conducted between June 2022 and April 2023 according to the experimental research model with pre-test and post-test control group. The research was completed with a total of 60 hemodialysis patients, 30 in the experimental group and 30 in the control group.


Eligibility criteria: Inclusion Criteria:

Being on hemodialysis treatment Being able to read and writeH

Exclusion Criteria:

Not knowing how to read or write, Having a psychological disorder that prevents speaking

Primary outcomes:
measure: Results
timeFrame: Time Frame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
state: Centre
city: Malatya
country: Turkey
facility: Inonu University
state: Centre
Study officials:
affiliation: İnönü Üniversitesi
name: Rukuye Aylaz, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03893643: Cutaneous and Mucosal Manifestations of Neurofribromatosis Type 2 in Children Under 15
Official title: Multicentre Prospective Observational Study: Resentment of Mucocutaneous Manifestations and the Value of Dermatological Examination in the Early Detection of Type 2 Neurofibromatosis in Children Under 15 Years of Age
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurofibromatosis 2
Dermatology/Skin - Other
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 1000
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with neurofibromatosis type 2

Brief summary: .Neurofibromatosis type 2 is an inherently autosomal dominant genetic disease, but cases of mosaicism or de novo mutation are not uncommon. the prevalence is estimated at 1 / 60,000. the clinical presentation is based on the appearance of tumors in the central and peripheral nervous system. The current average age of diagnosis is around 25 to 30 years depending on the studies. Currently, the diagnostic criteria are based on the ENT, neurological and opthalmological manifestations of the disease. Cutaneous manifestations have been described in these patients. Except now, mucocutaneous manifestations of the disease are not taken into account for depisatage or diagnosis.

The purpose of this study would be to identify the different cutaneous and mucosal manifestations in a pediatric population under 15 years of age, and to analyze whether this might be of interest in early detection of the disease in association with other symptoms.


Eligibility criteria: Inclusion Criteria:

* age up to 15 years
* diagnosis of neurofibromatosis type 2

Exclusion Criteria:

* refusal to participate in the study
* informed consent that can not be obtained because of a disability or difficulties with a - language barrier

Primary outcomes:
measure: number of cutaneo-mucous lesions present in children with neurofibromatosis type 2
timeFrame: 3 years
Secondary outcomes:
measure: number and type of neurological manifestations.
timeFrame: 3 years
measure: number and type of descriptioin of ENT manifestations.
timeFrame: 3 years
measure: number and type of ophthalmological manifestations.
timeFrame: 3 years
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice Hospital
Study officials:
References:
Clinical trial NCT02307643: Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
Official title: An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus


Eligibility criteria: Inclusion Criteria:

* Diagnosis of SLE based on the American College of Rheumatology (ACR) criteria
* Presence of at least one of the following items: positive anti ds-DNA antibodies, low complement levels, and so on.
* Stable doses of corticosteroids

Exclusion Criteria:

* Severe active lupus nephritis, neuropsychiatric SLE

Primary outcomes:
measure: Number of Subjects with Adverse Events
timeFrame: up to 36 weeks
Secondary outcomes:
measure: Change from Baseline in anti-dsDNA and complement
timeFrame: baseline and 24 weeks
measure: Change from Baseline in Lymphocyte counts
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: Inverstigational site
city: Chiba-shi
country: Japan
facility: Inverstigational site
city: Chuo-ku
country: Japan
facility: Inverstigational site
city: Fuchu-shi
country: Japan
facility: Inverstigational site
city: Fukuoka-shi
country: Japan
facility: Investigational site
city: Kawagoe-shi
country: Japan
facility: Inverstigational site
city: Maebashi-shi
country: Japan
facility: Inverstigational site
city: Meguro-ku
country: Japan
facility: Inverstigational site
city: Narashino-shi
country: Japan
facility: Investigational site
city: Sendai-shi
country: Japan
facility: Investigational site
city: Shimotsuga-gun
country: Japan
facility: Inverstigational site
city: Shinjuku-ku
country: Japan
facility: Inverstigational site
city: Tsukuba-shi
country: Japan
facility: Inverstigational site
city: Urayasu-shi
country: Japan
facility: Investigational site
Study officials:
affiliation: Keio University Hospital
name: Tsutomu Takeuchi, MD
role: STUDY_CHAIR
affiliation: University of Occupational and Environmental Health
name: Yoshiya Tanaka, MD
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Tanaka Y, Kondo K, Ichibori A, Yanai Y, Susuta Y, Inoue S, Takeuchi T. Amiselimod, a sphingosine 1-phosphate receptor-1 modulator, for systemic lupus erythematosus: A multicenter, open-label exploratory study. Lupus. 2020 Dec;29(14):1902-1913. doi: 10.1177/0961203320966385. Epub 2020 Oct 28.
Clinical trial NCT05938543: Cerebellar TMS and Satiety in Prader-Willi Syndrome
Official title: Noninvasive Neuromodulation of a Novel Cerebellar Satiety Circuit in Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prader-Willi Syndrome
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Foundation for Prader-Willi Research
First posted: 2023-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study hyperphagia and satiety in Prader-Willi syndrome.

TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study, the investigators will be stimulating the brain to learn more about how TMS might improve hyperphagia in Prader-Willi syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Prader-Willi syndrome

Exclusion Criteria:

* contraindications for TMS or MRI including :
* history of neurological disorder
* history of head trauma resulting in loss of consciousness
* history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy
* metal in brain or skull
* implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt claustrophobic in MRI

Primary outcomes:
measure: Retention of subjects in study assessments
timeFrame: 1-week post-TMS follow-up visit
measure: Time required to enroll subjects into study
timeFrame: At study completion, up to 18 months
measure: Change in BOLD response
timeFrame: baseline, 1-week post-TMS follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Laura Holsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06219343: Non-invasive Left-sided Cervical Vagus Nerve Stimulation for Atrioventricular Reentrant Tachycardia
Official title: Non-invasive Left-sided Cervical Vagus Nerve Stimulation for Atrioventricular Reentrant Tachycardia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrioventricular Reentrant Tachycardia
Keywords: non-invasive
vagus nerve stimulation
rapid return rhythm
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 10
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
Primary purpose: TREATMENT

Brief summary: The goal of this Interventional clinical trials in atrioventricular reentrant tachycardia patients. The main question it aims to answer whether non-invasive vagus nerve stimulation could be effective in restoring rhythm.

Patients will receive non-invasive vagus nerve electrical stimulation under catheter evoked and cardiac monitoring to observe their heart rhythm changes.

Detailed description: Participants will be treated with non-invasive electrical stimulation of the left vagus nerve in the neck. After routine induction of atrioventricular reentrant tachycardia prior to radiofrequency ablation, the electrode patch was placed on the patient's left cervical vagal body surface localization, i.e., between the sternocleidomastoid muscle and the trachea where the left common carotid artery pulsation could be palpated, and resuscitation was performed using non-invasive electrical stimulation.

Eligibility criteria: Inclusion Criteria:

1. The relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt) need to be met.
2. All need to be free of psychiatric abnormalities, verbal communication disorders, and have good compliance.
3. The patients and their families gave informed consent and signed the informed consent form.

Exclusion Criteria:

1. Does not meet the relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt).
2. Mental anomalies, verbal communication disorders, poor adherence
3. Those who do not consent to participate in this clinical trial

Primary outcomes:
measure: Whether the tachycardia is repetitive or not
timeFrame: 10minutes
Secondary outcomes:
measure: Parameters leading to tachycardia resumption
timeFrame: 10minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Ai-lan Chen
state: Guangdong
Study officials:
affiliation: The First Hospital of Guangzhou Medical University
name: Ai-lan Chen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00659243: Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
Official title: A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Pasteurized Breast Milk Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Replacement Therapy in Preterm Infants
Keywords: Replacement therapy
Pasteurized breast milk
Preterm infants
BSSL
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 32
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.

Detailed description: In this double-blind crossover study, patients will be randomized to receive pasteurized breast milk including BSSL or pasteurized breast milk without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.

Eligibility criteria: Inclusion Criteria:

* Preterm infants
* less than or equal to 32 weeks of gestational age
* appropriate for gestational age
* enterally fed with pasteurized breast milk

Primary outcomes:
measure: Coefficient of Fat Absorption measured in stool
timeFrame: Stool collected for a 72-hour period during the final 3 days of each treatment period
Secondary outcomes:
measure: Change in length and body weight
timeFrame: Baseline and after one week of treatment
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Marseille
country: France
facility: Hopital la Conception,
city: Nancy
country: France
facility: Maternité A. Pinard, Néonatologie
city: Paris
country: France
facility: Hopital Saint Vincent de Paul
city: Toulouse
country: France
facility: Hopital des Enfants
city: Tours
country: France
facility: CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville
city: Ancona
country: Italy
facility: Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi"
city: Padova
country: Italy
facility: Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria
Study officials:
affiliation: Biovitrum AB
name: Kristina Timdahl, MD
role: STUDY_DIRECTOR
References:
citation: Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vagero M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.
Clinical trial NCT06618443: Scapular Mobilization With Arm Movement in Patients With Adhesive Capsulitis.
Official title: Effect of Scapular Mobilization With Arm Movement on Shoulder Pain and Range of Motion and Disability in Older Adults With Adhesive Capsulitis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Adhesive Capsulitis
Keywords: scapular mobilization; arm movement; pain; range of motion; disability; older adults; adhesive capsulitis
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 50 patients with shoulder adhesive capsulitis were admitted. the patients will receive scapular mobilization (downward or upward mobilization) associated with arm movements. The percentage of improvement in shoulder ROM of flexion, abduction, and external rotation; and decrease in shoulder pain and disability index (SPADI).


Eligibility criteria: Inclusion Criteria:

* The existence of unilateral adhesive capsulitis (stage II) with incapability of the participant to raise the arm more than 100 degrees in the plane of the scapula

Exclusion Criteria:

* The presence of any shoulder problem contraindicated for performing exercises to the shoulder joint, such as active inflammatory disease, cancer, active infection, recent subluxations or dislocations, fractures, and surgeries near the shoulder region.

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 3 months
measure: Shoulder range of motion of flexion, abduction, and external rotation
timeFrame: 3 months
measure: Scapular dyskinesis
timeFrame: 3 months
measure: Electromyography
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: