louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01184833: Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis
Official title: Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Interferon beta-1b
Compliance to treatment
Premature treatment discontinuation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-08-19
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.

Brief summary: Non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. Betaferon) that are used in multiple sclerosis patients.

Certain patients omit single injections or even totally discontinue therapy that normally should be long-term. It is therefore crucial to identify the factors which have the most significant effect on regularity of administration of Betaferon and the risk of premature discontinuation of treatment in order to undertake appropriate preventive measures.

This study is conducted in routine practice setting and aims to identify those risks. Pre-defined risk factors associated with technical aspects of the treatment, support provided to the patient, stage of the disease and possible adverse effects of the medication are checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the prescribed medication (Betaferon) is carried out by the study nurse.


Eligibility criteria: Inclusion Criteria:

* Relapsing-remitting multiple sclerosis
* Age \>/= 18 years
* Start of treatment with Betaferon not earlier than 60 days prior to inclusion

Exclusion Criteria:

* Synonymous with contraindications to Betaferon

Primary outcomes:
measure: Rate of discontinuation of Betaferon
timeFrame: 24 months
Secondary outcomes:
measure: Number of missed doses of Betaferon
timeFrame: 24 months
measure: Depression score as measured by CES-D questionnaire
timeFrame: 24 months
measure: Neurological disability score as measured by EDSS scale
timeFrame: 24 months
measure: Overall tolerability of treatment as measured by rate of adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01442987: Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
Official title: Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Hyperlipidemia
Keywords: Irbesartan
Atorvastatin
Hypertension
Hyperlipidemia
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2011-09-29
Enrollment: 230
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.


Eligibility criteria: Inclusion Criteria:

* Aged between 19 and 75 years
* Signed informed consent

Exclusion Criteria:

* At screening, SPB ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C \> 250mg/dL or TG ≥ 400mg/dL
* Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug
* Has a history of multi-drug allergy

Primary outcomes:
measure: Percent change from baseline to 8 week in LDL-Cholesterol
timeFrame: baseline and 8 week
measure: Change from baseline to 8 week in Blood Pressure.
timeFrame: baseline and 8 week
Secondary outcomes:
measure: Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline.
timeFrame: week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 16 institutions including Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Byeong Hee Oh, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SH, Jo SH, Lee SC, Lee SY, Yoon MH, Lee HL, Lee NH, Ha JW, Lee NH, Kim DW, Han GR, Hyon MS, Cho DG, Park CG, Kim YD, Ryu GH, Kim CH, Kim KS, Chung MH, Chae SC, Seung KB, Oh BH. Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia: A Randomized, Double-blind, Factorial, Multicenter Phase III Study. Clin Ther. 2016 Oct;38(10):2171-2184. doi: 10.1016/j.clinthera.2016.09.005. Epub 2016 Oct 12.
Clinical trial NCT06849687: Effect of Whole Body Vibration in Young Females With Smartphone Addiction
Official title: Effect of Whole Body Vibration on Hand Grip Strength, Muscular Activity, and Upper Limb Function in Young Females With Smartphone Addiction: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smart Phone Addiction
Keywords: whole body vibration
hand grip strength
muscle activity
upper limb function
smart phone addiction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Young adults have a high prevalence of smartphone addiction. Many adolescents use their smartphones extensively for communication, which starts out as a habit but eventually turns into an addiction. Numerous studies have shown that adolescents use social media for roughly ten hours every day.


Eligibility criteria: Inclusion Criteria:

* High smartphone users according to the Smartphone Addiction Scale Short Version (SAS- SV)
* Body mass index (BMI) less than 30 kg/m²
* Didn't receive regular exercise in the last 6 months.

Exclusion Criteria:

* Medical history of median nerve release, hand or thumb tendon lesion
* Prior hand or wrist fractures
* Medical history of hand injuries, and upper limb skin diseases
* WBV contraindications include (joint issues, acute inflammations, back pain, epilepsy, diabetes, or neuromuscular disorders, or dizziness, any discomfort, and nausea)

Primary outcomes:
measure: Hand grip strength
timeFrame: 4 weeks
Secondary outcomes:
measure: pinch strength
timeFrame: 4 weeks
measure: Muscle activity of flexor carpi radialis muscle
timeFrame: 4 weeks
measure: Muscle activity for flexor carpi ulnaris muscle
timeFrame: 4 weeks
measure: Muscle activity for extensor digitorum communis muscle
timeFrame: 4 weeks
measure: Upper limb function
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
References:
Clinical trial NCT06103487: Long Term Follow-Up for RGX-111
Official title: A Long-term Follow-up Study to Evaluate the Safety of RGX-111
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Mucopolysaccharidosis I
Keywords: MPS I
hurler syndrome
gene therapy
Lead sponsor: REGENXBIO Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Received RGX-111 in a separate parent trial.

Brief summary: RGX-111-5101 is a long-term follow up study that evaluates the long term safety of RGX-111 in participants who have received RGX-111 (a gene therapy intended to deliver a functional copy of the alpha-L-iduronidase gene (IDUA) to the central nervous system) in a separate parent study.

Detailed description: This is a prospective, multicenter, observational, follow-up study to evaluate the long-term safety of RGX-111 after a single administration. Eligible participants are those who previously participated in a clinical study where they received a single IC or ICV administration of RGX-111. Enrollment of each participant in this study should occur on the same day or after the participant has completed the end of study (EOS) visit or early discontinuation visit (EDV) from a previous (parent) clinical study. Participants will be followed for up to five years after RGX-111 administration (inclusive of the parent study) or until RGX-111 is commercially available in the participant's country, whichever occurs first. No treatment will be directed under this observational protocol. The total study duration for each participant may vary depending on when s/he enrolls in the current study following RGX-111 administration in the parent study.

Eligibility criteria: Inclusion Criteria:

* To be eligible, a participant must have previously received RGX-111 in a separate parent trial.
* Participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Evaluation of the long-term safety of RGX-111
timeFrame: 5 years inclusive of parent study
Secondary outcomes:
measure: Safety and Efficacy: Change from baseline in neurodevelopmental parameters
timeFrame: 5 years inclusive of parent study
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
References:
Clinical trial NCT02017587: Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection
Official title: Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Lead sponsor: Vaccine and Gene Therapy Institute, Florida
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients volunteers

Brief summary: The objective of the study is to procure blood (plasma, serum, RNA and PBMC samples) from approximately 40 chronic HBV for biomedical research program led by VGTI Florida.

Detailed description: During chronic HBV infection, a dynamic balance between viral replication and the host immune response is pivotal to the pathogenesis of liver disease. HBV specific T-cell function is impaired in patients with chronic HBV infection characterized by low levels of antiviral cytokines, impaired cytotoxic T lymphocyte activity, and persistent viremia. However, the mechanism underlying this T-cell malfunction in chronic HBV infection has not been completely understood.

The biomedical research on the samples obtained during this study will include, among other studies, advanced flow cytometry to study the Treg and activation markers, negative regulatory molecules and phenotype of CD4 and CD8 subsets using the extended panel markers developed at VGTI Florida. Additional antibody panels for measuring functional CD4 responses by ICS, DC subsets, activation, and signaling pathways by phos

Eligibility criteria: Inclusion Criteria:

* Patient with chronic HBV infection documented by presence of HBsAg for at least 12 months currently untreated for HBV infection or under stable antiviral therapy

Exclusion Criteria:

* Prior use of HBV therapeutic vaccine
* Currently treated with interferon alpha or other immune modulator(s)
* Acute HBV infection
* Chronic inactive HBV carrier
* under an acute flare/reactivation of HBV infection defined as symptoms of acute hepatitis and recent elevation of aminotransferase (over 10 x ULN) or bilirubin levels
* Known co-infection with HCV, HDV, and/or HIV
* Under renal dialysis
* For female patients, pregnant or breastfeeding
* Cirrhosis, hepatocellular carcinoma or liver transplantation
* active autoimmune disease including autoimmune hepatitis

Primary outcomes:
measure: T lymphocyte phenotype and functional response in chronic HBV infection
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Health System
name: Richard Sterling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06515054: Isometric Exercise for Hypertension
Official title: Effectiveness and Mechanisms of Isometric Resistance Exercise to Reduce Blood Pressure in a Chinese Population: a Pilot Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control.

Methods: This is a pilot randomized controlled trial that will involve 50 patients with hypertension (HT) who do not meet the current physical activity guidelines defined by the World Health Organization. Participants will be randomly assigned in a 1:1 ratio using stratified and blocked randomization to either the IRE (wall squat) group or stretching exercise (active control) group. A well-structured, widely accepted, and validated 24-week wall squat program (2 minutes per exercise, 2 minutes of rest between sets, and 3 sessions per week) will be implemented, as it has been commonly used in previous research. All patients will be followed up for 24 weeks. Control group will receive exact same treatment except that IRE is replaced by frequency-matched and time-matched stretching exercise. The primary outcome measure will be rate of recruitment. Secondary outcomes will include BP parameters from 24-hour ambulatory BP monitoring


Eligibility criteria: Inclusion Criteria:

* a suboptimal daytime SBP of \>135-160 mmHg on a 24-h ABPM
* reported no regular physical activity or less than that recommended for adults by the World Health Organization (e.g. \<150 minutes of moderate-intensity aerobic exercise per week);
* on stable doses of anti-HT medication(s) for ≥4 weeks if the patient is receiving drug treatments
* agree for no drug changes during the intervention period (24 weeks);

Exclusion Criteria:

* cannot provide informed consent
* unwillingness to repeat ABPM
* relative contraindications to ABPM (i.e. diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies)
* severe osteoarthritis pending knee replacement surgery
* known secondary HT
* use of ≥3 anti-HT medications at maximum doses or ≥4 anti-HT medications
* SBP or DBP are \>160 mmHg or \>100 mmHg, respectively, on ABPM
* pregnancy/breastfeeding
* active malignancy

Primary outcomes:
measure: rate of recruitment
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Blood pressure parameters
timeFrame: 24-week after recruitment
measure: Carotid-femoral pulse wave velocity
timeFrame: 24-week after recruitment
measure: flow-mediated velocity (FMD)
timeFrame: 24-week after recruitment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of public health and primary care
Study officials:
References:
Clinical trial NCT03375554: The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure
Official title: The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation Complication
Keywords: esophageal steothoscope, tracheal intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2017-12-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient receiving general anesthesia for elective surgery

Brief summary: The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure during general anesthesia.

Detailed description: It is well known that cuff pressure of tracheal tube should not be over 30 cmH2O. Therefore, anesthesiologists usually pay attention to maintain adequate cuff pressure, especially just after completion of tracheal intubation. Recently, esophageal stethoscope is widely used for exact monitoring of patient's body temperature. However, inserting of foreign body in esophagus could affect on the cuff pressure.

The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure.

Eligibility criteria: Inclusion Criteria:

* Patient receiving general anesthesia for elective surgery

Exclusion Criteria:

* who doesn't agree to enroll
* who has any clinical disease or history of surgery in esophagus
* who has aspiration tendency

Primary outcomes:
measure: Change of cuff pressure
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jung-Man Lee, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02413554: Rivastigmine Patch Effect on the Post-operative Delirium in Patients at Risk of Dementia.
Official title: Rivastigmine Patch Effect on the Post-operative Delirium Limited to Femur Neck Fracture Operation in Patients at Risk of Dementia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Delirium
Keywords: acetylcholinesterase inhibitors
rivastigmine patch
post-operational delirium
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Delirium is a common and serious condition and is associated with adverse outcome. The elderly who have cognitive dysfunction are expected to show delirium more frequently. It is most likely that delirium represents a response to impaired cholinergic neurotransmission. Investigators aimed to establish the preventive effect of the cholinesterase inhibitor, rivastigmine patch, on the post-operative delirium limited to femur neck fracture operation in patients at risk of dementia.

Detailed description: Investigators evaluated the delirium prevention effect of rivastigmine patch in patients with femur neck fracture and cognitive impairment. Investigators measured the frequency and severity of post-operation delirium in the patch applied and non-applied subjects.

Eligibility criteria: Inclusion Criteria:

* Consecutively enrolled the patients who is going to operation after femur neck fracture.
* Patients agree to the informed consent.

Exclusion Criteria:

* depressive mood and their geriatric depression scale is over 6 / 15.
* Their Korean version MMSE(minimental status examination) are over 25, or global dementia scale (GDS) are under 3 or over 5.
* any delirious state at pre-operation period by DSM IV and CAM (Confusion Assessment Method)

Primary outcomes:
measure: the number of participants with delirium
timeFrame: up to 7th days
Secondary outcomes:
measure: delirium severity using delirium rating scale
timeFrame: up to 7th days
Other outcomes:
Locations:
Study officials:
affiliation: Dept of Neurology, Chung-Ang University Hospital
name: Young Chul Youn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05348954: Determining the Effects of Sexual Health Education and Counseling Given to Women in the Postpartum Period Based on the EX-PLISSIT Model on Sexual Life
Official title: Determining the Effects of Sexual Health Education and Counseling Given to Women in the Postpartum Period Based on the EX-PLISSIT Model on Sexual Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexuality
Nurse's Role
Postpartum Disorder
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2022-04-27
Enrollment: 88
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled experimental study
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to determine the effect of the sexual health education and counseling program, which is given to women in the postpartum period based on the Ex-PLISSIT model, on women's sexual life, including sexual function, sexual distress and sexual life quality.

Detailed description: The study is a multicenter, parallel randomized controlled experimental study with block randomization.For the determination of the working groups, the researcher; will give general information about the research to women who have applied to the family health center and meet the inclusion criteria in the postpartum period of 10 weeks-6 months and agree to participate, and will receive their written and verbal consent for participation.

Eligibility criteria: Inclusion Criteria:

* Being primiparous
* Having given birth at 38-42 weeks of gestation,
* Having a single birth,
* Not experiencing any postpartum complications
* The time elapsed from birth is between 10 weeks and 6 months
* Being sexually active
* Having a spouse/partner
* Having a smartphone or computer with a camera
* Being at least literate

Exclusion Criteria:

* A previous sexual function of the woman herself or her husband.
* Having a chronic disease that she expresses herself (such as cardiovascular disease, hypertension, etc.)
* Having a health problem that requires the baby to be hospitalized
* Having received sexual education/counselling
* Spouse or self-diagnosed mental problem
* Having a diagnosis that will affect sexual function or body image, such as mastectomy

Primary outcomes:
measure: EX-PLISSIT Model
timeFrame: EX-PLISSIT Model will be conducted to participants one weeks later after the first session
measure: THE FEMALE SEXUAL DISTRESS SCALE-REVISED
timeFrame: They will get an sexual health education and then their sexual disstress will be measured 4 weeks later
measure: SEXUAL QUALITY OF LIFE SCALE-FEMALE
timeFrame: They will get an sexual health education and then their sexual quality of life will be measured 4 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Halk Sağlığı Müdürlüğü
state: Merkez
Study officials:
References: