louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06389461: 4th Ventricular Compression Technique on Anxiety
Official title: The Efficacy of the 4th Ventricular Compression Technique on Anxiety in Students: RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Anxiety
College Students
CV4
Osteopathic treatment
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Determinate the effects of the technique of 4th ventricle in college students with anxiety, applying the technique one time per week during three weeks.

Detailed description: The anxiety is a warning sign that makes it possible for the individual to defend themselves and protect themselves from threats. This is considered a natural and necessary reaction for self-preservation. However, when it appears persistently, exaggeratedly or disproportionately in relation to a stimulus, the following are considered: pathological anxiety.

The compression of the fourth ventricle (CV4) is one of the most well-known procedures in the practice of cranial manipulation. It is also one of the most clinically tested techniques and has been postulated to be associated with decreased sympathetic tone.

Therefore, this was the chosen technique, as it significantly affects the relaxation of the SNS tonus and, thereafter, anxiety.

Eligibility criteria: Inclusion Criteria:

* Ages between 18 and 25 years old;
* Be a college/university student;
* Not have knowledge of the technique used;
* Achieve a 20 plus score on the State-Trait Anxiety Inventory questionnaire.

Exclusion Criteria:

* Use of pharmacological therapy for psychological disorders;
* Presence of conditions that prevent or contraindicate the technique, including tumors, fractures, dislocations, vertebrobasilar insufficiency, bone diseases, neurological diseases, fever, skin diseases, cardiovascular diseases, psychiatric diseases, increased intracranial pressure.
* Surgeries or traumas in the specific areas of the technique;
* Pregnancy;
* Osteopathic treatments or other manual therapies aimed at reducing anxiety;
* Evident postural alteration or deformity of the thoracic cage.

Primary outcomes:
measure: Change from baseline in anxiety levels through the STAI (The State-Trait Anxiety Inventory) questionnaire score on the 1st and last intervention.
timeFrame: One week after the last intervention
Secondary outcomes:
measure: Change from baseline in thoraco-abdominal perimetry on the 1st and last intervention
timeFrame: Immediately after last intervention
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior da Saúde do Porto
Study officials:
affiliation: Escola Superior da Saúde do Porto
name: Natália MO Natália
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00227461: Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.
Official title: Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Aphasia
Stroke
Keywords: Aphasia
Stroke
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2005-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.

Detailed description: In the study, 50 post-stroke subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design.

Eligibility criteria: Inclusion Criteria:

* Stroke
* Aphasia
* Can give consent

Exclusion Criteria:

* Renal failure
* Pregnancy
* Other neurological condition

Primary outcomes:
measure: Speech and language assessment
timeFrame: 6 months - 1year
Secondary outcomes:
measure: Memory assessment
timeFrame: 6 months to 1 year
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: A.M. Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04672161: Education Intervention on Vaccination Adherence Among Inflammatory Bowel Disease (IBD) Patients
Official title: Education Intervention on Vaccination Adherence Among IBD Patients at Weill Cornell Medical Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease (CD)
Ulcerative Colitis (UC)
Indeterminate Colitis
Keywords: Vaccine
HPV
Vaccination
IBD
Inflammatory Bowel Diseases
UC
CD
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A retrospective chart review and a six-month prospective outcome analysis aimed to evaluate the efficacy of a vaccination education intervention and vaccination adherence among IBD patients at Weill-Cornell Medical Center. It is hypothesized that a general vaccination education campaign will improve vaccination adherence rates for all IBD patients. Secondarily, it is hypothesized that an Human Papilloma Virus (HPV) vaccination intervention targeted at high-risk IBD patients will increase vaccination adherence among these patients.


Eligibility criteria: Inclusion Criteria:

* Patient at Weill-Cornell Medical Center with an in-person or virtual appointment between March 1 - August 30, 2021.
* Documentation of an IBD diagnosis (CD, UC, IC).

Exclusion Criteria:

* No documentation of an IBD diagnosis.
* Pregnant or breastfeeding.
* No scheduled appointment between March 1-August 30, 2021.

Primary outcomes:
measure: Mean Change in Vaccination Adherence in Patients
timeFrame: Baseline; 6 months
Secondary outcomes:
measure: Change in qualitative attitude assessment on vaccination adherence and non-adherence as measured by self-reported 6-month questionnaire.
timeFrame: Baseline; 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Dana J Lukin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05497661: Ultrasound Patellar Tendon Assessment
Official title: Ultrasound Patellar Tendon Assessment and Thermography After 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain
Ultrasonography
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.

Detailed description: Patellar tendon injuries is is one of the most common musculoskeletal disorders, presenting a high prevalence in sport populations. Many factors have been proposed as the cause of pain and dysfunction, however there are no studies analysing possibilities of preventing patellar tendon injuries by using a radiofrequency stimulus.

The use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored.

The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the patellar tendon will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.

The stimulus will be carried out on the patellar tendon region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

Eligibility criteria: Inclusion Criteria:

* Age between 18-65 years.
* Sporty people with at least 3 days of training per week

Exclusion Criteria:

* Suffer from knee pain.
* Sedentary people

Primary outcomes:
measure: Change from Baseline in patellar tendon measured by quantified elastography imaging at 3 months [ Time Frame: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)] ]
timeFrame: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Secondary outcomes:
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Clínica Ana González
Study officials:
affiliation: University of Malaga
name: Santiago Navarro Ledesma
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaga
name: Ana González Muñoz
role: STUDY_CHAIR
References:
Clinical trial NCT01544361: A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Official title: A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Healthy subjects
MEDI7814
FTiH
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.

Detailed description: This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult male subjects and female subjects of non-childbearing potential.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years up to and including 49 years at the time of first dose of investigational product
* Healthy by medical history, physical examination, and laboratory studies
* Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m\^2) (inclusive)
* Females must be of non-childbearing potential.

Exclusion criteria:

* Any acute illness within 30 days of screening
* Concurrent enrollment in another clinical trial
* The subject has a positive drug/alcohol screen at screening or Day -1
* Pregnancy
* Current cigarette smokers
* History of cancer other than non-melanoma skin cancer or in situ carcinoma of the cervix treated with apparent success
* Use of immunosuppressive medications
* Subjects who have an unresolved infection with any Neisseria species
* Subjects who have had their spleen removed for any reason.

Primary outcomes:
measure: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 to Day 106
Secondary outcomes:
measure: Pharmacokinetic (PK) Parameters of MEDI7814
timeFrame: Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106
measure: Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814
timeFrame: Day 1, 29, 57, 85, and 106
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Research Site
state: Nebraska
Study officials:
affiliation: Research site
name: Alan Marion, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03975361: Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE)
Official title: Tolerance Checkpoints Upon the B-cell Depletion Plus BAFF Blockade Strategy in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) (Checkpoints ITP and SLE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immune Thrombocytopenia (ITP)
Systemic Lupus Erythematosus (SLE)
Keywords: Rituximab
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2019-06-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this proposal is to test if anti-BAFF antibody can restore a normal threshold of tolerance in patients in two auto-immune diseases along the RITUX-PLUS study in immune thrombocytopenia, and along the Believe study in SLE. This work would help to conclude whether or not the 'double hit' therapy may help to reset the immune system toward a more tolerogenic profile.

The aim is to compare the polyreactivity and autoreactivity, of immature (central tolerance) and naïve B cells (peripheral tolerance) in the peripheral blood along the RITUX-PLUS STUDY and the BLISS BELIEVE study after treatment (B-cell reconstitution time).


Eligibility criteria: There are no specific inclusion and exclusion criteria for this study.

The inclusion and exclusion criteria are those of patients enrolled in the RITUX-PLUS (NCT03154385) and BLISS BELIEVE studies (NCT03312907) including the following inclusion criteria:

* individuals are affiliated to social security
* individuals not be placed under judicial protection, guardianship or curatoship

Primary outcomes:
measure: Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: Henri Mondor Hospital
city: Paris
country: France
facility: Pitie Salpetriere Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Mahevas Matthieu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03790761: Guam Healthy Relationships Education Program
Official title: Guam Healthy Relationships Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Guam
healthy relationships
non-profit organization
PREP 8.0 curriculum
Lead sponsor: WestCare Pacific Islands, Inc.
Sponsor class: OTHER
Collaborators: name: Children's Bureau - Administration for Children and Families
First posted: 2019-01-02
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Guam Healthy Marriage Partnership (GHMP), a comprehensive culturally responsive program that will foster healthy relationships and marriages on the island of Guam.

Detailed description: The proposed Guam Healthy Relationships Education Program will improve the quality of life for individuals/couples in Guam by using culturally responsive approaches to foster healthy relationships and marriages using an Observational approach as there will be no comparison group, only the control group. Project activities include a 6-month education program of interactive curriculum-based groups and positive social/recreational activities to achieve positive outcomes for individuals/couples, community awareness events, and community and parenting skills training. The services offered is entrenched in cultures and traditions that are meaningful to the people of Guam, and includes capacity building and community awareness activities that will change community, family, and peer normative environments and attitudes.

Eligibility criteria: Inclusion Criteria:

* Currently in a long-term relationship, does not have to include marriage
* Must be at least 18 years old
* At least one of the partners need to be between the ages of 18-35 years old

Exclusion Criteria:

* Under the age of 18 years
* Not in a long-term relationship

Primary outcomes:
measure: Change in Relationship Satisfaction
timeFrame: The pre-test is administered before starting the curriculum and the post-test is administered immediately following the conclusion of the curriculum.
Secondary outcomes:
measure: Change in Intimate Partner Violence
timeFrame: The screening is administered before starting the curriculum and the screening is administered again immediately following the conclusion of the curriculum.
Other outcomes:
Locations:
city: Hagatna
country: Guam
facility: WestCare Pacific Islands Reflection Center
Study officials:
affiliation: WestCare Foundation, Inc.
name: Melissa Rhea, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01257061: Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment
Official title: Unicentric Comparing Effectiveness Superiority of to Clemastine Fumarate 1, 0 mg/g + Dexamethasone 0, 5 mg/g to Dexchlorpheniramine Maleate 10 mg/g in Eczema Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eczema
Keywords: Dermatitis
Dermatitis, Atopic
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 310
Sex: ALL
Minimum age (years): 5
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.

Detailed description: Study design:

• Double blinded, superiority, prospective parallel-group, intend to treat trial.

Study design:

* Experiment duration: 22 days
* 2 visits (days 1,7,15 and 22)
* Reducing Eczema Area and severity index evaluation
* Adverse events evaluation

Eligibility criteria: Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with acute or sub-acute eczema.
3. Presence of symmetric lesions to compare on side to the other.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
4. Sunlight over exposure in the last 15 days.
5. Any pathology or past medical condition that can interfere with this protocol.

Primary outcomes:
measure: Reduction / improvement of signs and symptoms
timeFrame: DAY 22
Secondary outcomes:
measure: Adverse Events Evaluation
timeFrame: DAY 22
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin instituto da Pele
state: São Paulo
Study officials:
affiliation: Medcin Instituto da Pele
name: Flavia Addor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EMS
name: Felipe Pinho, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01739361: Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis
Official title: Phase IIa Randomized Controlled Trial of Acetaminophen for the Reduction of Oxidative Stress in Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Sepsis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 44
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: Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia, hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free hemoglobin in these patient population has been associated with poor outcomes, including an association with an increased risk of death. Acetaminophen may have a protective effect in these patient populations by inhibiting hemoprotein-mediated lipid peroxidation. The purpose of the present trial is to study the effect of acetaminophen on lipid peroxidation in adults with severe sepsis and detectable cell-free hemoglobin.

The primary hypothesis is that systemic markers of oxidative stress and lipid peroxidation, as measured by F2-isoprostanes, will be significantly lower in patients with severe sepsis and detectable cell-free hemoglobin who receive acetaminophen compared to placebo. The secondary hypothesis is that patients with severe sepsis and detectable cell-free hemoglobin treated with acetaminophen will have better clinical outcomes, including decreased incidence of acute kidney injury and lower rates of hospital mortality, compared to those who receive placebo.


Eligibility criteria: Inclusion Criteria:

* Males and Female \>=18 years old
* Admitted to an Intensive Care Unit
* Severe Sepsis
* Detectable plasma cell-free hemoglobin

Exclusion Criteria:

* patients who received acetaminophen in the past 48 hours prior to enrollment
* intolerance or allergy to acetaminophen
* measured AST/ALT \>400 U/L in the 24 hours prior to enrollment
* chronic liver disease defined by a Child-Pugh score \>4
* cannot swallow or have no enteral feeding access
* patients with no detectable cell-free hemoglobin
* patients transitioned to palliative care
* pregnant patients or women of childbearing potential without a documented pregnancy test

Primary outcomes:
measure: F2-isoprostanes After 72 Hours of Acetaminophen or Placebo
timeFrame: 72 hours after randomization
Secondary outcomes:
measure: In-hospital Mortality
timeFrame: Patients will be followed through the end of their hospital stay, an average of 5 weeks
measure: Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo
timeFrame: 72 hours
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: