louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06551376: LATE LUTEAL PHASE VS. CONVENTIONAL EARLY FOLLICULAR PHASE START IN IVF
Official title: IVF CYCLE SCHEDULING WITH LATE LUTEAL PHASE VS. CONVENTIONAL EARLY FOLLICULAR PHASE START TO AVOID WEEKENDS RETRIEVALS: PROOF OF CONCEPT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: IVF
Keywords: Ovarian Stimulation
luteal phase start
early follicular phase start
ovarian response
Lead sponsor: Clinia de fertilización Asistida en el Hospital ABC
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.

Detailed description: Objective To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.

Design Multicentric prospective non-randomized study

Setting Two university-affiliated private assisted reproduction centers.

Patient(s) Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled. Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria.

Intervention(s) Twenty patients started controlled ovarian stimulation (COS) after spontaneous menses; similarly, twenty patients started stimulation on the Friday previous to a spontaneous menses (at the end of late luteal phase), regardless of cycle day.

Main Outcome Measure(s) Primary outcome: number of mature oocytes retrieved. Secondary outcomes: fertilization rate, viable embryo rate per oocyte retrieved, cancellation rate, and clinical pregnancy outcomes from FET cycles.

Eligibility criteria: Inclusion Criteria:

* Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled

Exclusion Criteria:

* Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria

Primary outcomes:
measure: mature oocytes retrieved
timeFrame: At retrieval
Secondary outcomes:
measure: fertilization rate
timeFrame: 24 hours after retrieval
measure: viable embryo rate per oocyte retrieved
timeFrame: 5 days after retrieval
measure: cancellation rate
timeFrame: 14 days after cycle start
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02180776: Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis
Official title: A Randomized Crossover Pilot Study To Determine Clinical Effectiveness and Patient Wellness of Inelastic Lumbosacral Orthoses Versus Standard Medical Treatment in Patients With Back Pain AssociatEd With Kyphosis (The ARISE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kyphosis
Back Pain
Lead sponsor: Aspen Medical Products
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate clinical effectiveness and the effect on quality of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic patients with moderate to severe back pain disability and to demonstrate the safety of the intervention through detailed reporting and analysis of adverse events.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to complete disability (crippled) as defined by a score of 21% to 80% on the baseline evaluation of the Oswestry Back Pain Disability Questionnaire;
* Patients diagnosed with kyphosis and have a Cobb angle of at least 55 degrees;
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

* Patients under the age of 19;
* Pregnant patients or patients who are considering future pregnancies;
* Patients who were participating in any other investigational device or drug study or whose participation in a previous investigational study within 30 days of study entry may, in the opinion of the clinical investigator, impact analysis of this orthotic;
* Patients who, in the clinical judgment of the investigator, are not suitable for this study; Patients who, in the investigators opinion, are mentally or legally incapacitated preventing informed consent or unable to read or understand written material;
* Patients who are unable or unwilling to return to the study center for follow-up visits.

Primary outcomes:
measure: Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups
timeFrame: 4 weeks
Secondary outcomes:
measure: Measured amount of opioid medication consumed in the intervention group versus control group
timeFrame: Baseline and weeks 2,3,4,8,12,16,20 and 24
Other outcomes:
measure: ODI scores between the intervention group versus control group
timeFrame: Weeks 8, 12, 16, 20 and 24
measure: SF-26v2 Survey scores in the intervention versus the control group
timeFrame: Baseline and weeks 4, 8, 12 and 24.
measure: Cost and return on investment of the LSO intervention
timeFrame: 24 weeks
measure: Number of adverse events associated with the LSO intervention
timeFrame: Baseline and weeks 2, 3, 4, 8, 12, 16, 20 and 24
Locations:
Study officials:
affiliation: Southeastern Integrated Medical
name: Daniel J Schaffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01737476: Trial to Evaluate the Efficacy of the HLPFC Coil Deep Transcranial Magnetic Stimulation System in Treating Attention Deficit and Hyperactivity Disorder (ADHD) in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Disorder Patients
Keywords: age 18-65
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the efficacy of trans-cranial magnetic stimulation in treating attention deficit disorder in adults.


Eligibility criteria: Inclusion Criteria:

* 18-65 years
* ADD/ADHD

Exclusion Criteria:

* any DSM-IV psychiatric disorder except ADD/ADHD
* use of psychoactive medications
* Epilepsy
* brain injury

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Ben-Gurion University
Study officials:
References:
citation: Hadas I, Hadar A, Lazarovits A, Daskalakis ZJ, Zangen A. Right prefrontal activation predicts ADHD and its severity: A TMS-EEG study in young adults. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Dec 20;111:110340. doi: 10.1016/j.pnpbp.2021.110340. Epub 2021 May 3.
Clinical trial NCT00070876: Psychosocial Training for Pediatric Health Care Providers
Official title: Trial of Psychosocial Training for Pediatric Generalists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders Diagnosed in Childhood
Keywords: Child
Adolescent
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-10-09
Enrollment: 350
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study will provide psychosocial training to general health care providers to help them provide better care to children with mental health problems.

Detailed description: Up to 20% of school-age children have one or more mental health conditions that require treatment. These conditions are often treated by generalists. However, a significant proportion of children who seek treatment from generalists do not receive effective treatment. Studies indicate that generalists who treat adults can improve the administration of treatment after taking part in training programs, but these studies have yet to be translated into pediatric settings. This study will conduct a training program to help generalists provide effective treatments to children with mental health problems.

This study will evaluate a two-session, highly interactive training program in which general clinicians receive psychosocial training. The training program includes skills related to engaging parents and children, problem identification, solution-focused cognitive therapy, and making effective mental health referrals.

The child's mental health symptoms, functioning, changes in utilization of pediatric services, and utilization of community services will be measured along with the mother's emotional well-being and family functioning.

Eligibility criteria: Inclusion Criteria for Health Care Providers:

* Generalist clinician in primary care practice seeing children 6 to 16 years of age

Inclusion Criteria for Patients:

* 6 to 16 years of age
* Seeing a study-enrolled provider
* English or Spanish speaking
* Not in acute pain

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Public Health
state: Maryland
Study officials:
References:
citation: Wissow LS, Gadomski A, Roter D, Larson S, Brown J, Zachary C, Bartlett E, Horn I, Luo X, Wang MC. Improving child and parent mental health in primary care: a cluster-randomized trial of communication skills training. Pediatrics. 2008 Feb;121(2):266-75. doi: 10.1542/peds.2007-0418.
Clinical trial NCT06043076: iTBS Effect on M1 Plasticity, Blood Glucose, and Cardiovascular Response
Official title: The Effect of Intermittent Theta-Burst Stimulation on Motor Cortical Plasticity, Blood Glucose, and Cardiovascular Response in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Young Adults
Keywords: Transcranial magnetic stimulation (TMS)
Intermittent theta-burst stimulation (iTBS)
Primary motor cortex (M1)
Neuroplasticity
Heart rate
Blood pressure
Blood glucose
Healthy
Young adults
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Transcranial magnetic stimulation is a medical device that can alter motor cortical (M1) excitability through the scalp via various protocols. Among these, intermittent theta-burst stimulation (iTBS) is a novel protocol that enhances the M1 excitability for several minutes beyond stimulation. The changes in M1 excitability might in turn be accompanied by other physiological responses in the human body. This study will explore the effect of iTBS protocol on M1 plasticity, heart rate, blood pressure, and blood glucose in healthy young adults in comparison to sham stimulation.


Eligibility criteria: Inclusion criteria:

* Healthy young adults (18-35 years old)
* Right-handed
* Fully vaccinated against COVID-19

Exclusion criteria:

* Subjects with contraindications to TMS based on the screening 13-item questionnaire for TMS candidacy
* Smokers
* Obese (BMI ≥ 30)
* Highly active subjects
* Active or previous lab-confirmed COVID-19 with long symptoms

Primary outcomes:
measure: Motor evoked potential (MEP)
timeFrame: Pre-iTBS (baseline) and post-iTBS at 5,10,20, and 30 minutes
Secondary outcomes:
measure: TMSens_Q questionnaire
timeFrame: At the end of every session
measure: Blood glucose
timeFrame: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
measure: Blood pressure
timeFrame: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
measure: Heart rate
timeFrame: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
measure: Baseline corticospinal excitability indices
timeFrame: Baseline
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Hospital Sultan Abdul Aziz Shah
state: Selangor
Study officials:
References:
Clinical trial NCT03639376: Passive Smoking and LL-37 in Children
Official title: Salivary LL-37 and Periodontal Health in Children Exposed to Passive Smoking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Innate Immunity
Periodontal Health
Keywords: Children
Cotinine
LL-37
Passive smoking
Periodontal health
Saliva
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children were selected from patients referred to Kirikkale University, Faculty of Dentistry, and Department of Pediatric Dentistry

Brief summary: This study investigates the salivary LL-37 in passive smoking-exposed and unexposed children and the association between salivary LL-37 levels and periodontal clinical parameters in these children.Unstimulated salivary samples were collected from 180 children (90 passive smoking-exposed and 90 passive smoking-unexposed)

Detailed description: Diverse mechanisms conduce to the detrimental periodontal effects of passive smoking, including alteration of both microbial and host response factors.

Antimicrobial peptides are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the oral gingival epithelium and in the transition to acquired immunity.

LL-37 has a wide antimicrobial activity against both cariogenic and periopathogenic bacteria and its role in maintaining oral health has recently been stated

Eligibility criteria: Inclusion Criteria:

* Systemically healthy children

Exclusion Criteria:

* Any medications known to affect defense system and periodontium
* The presence of orthodontic / intraoral appliance

Primary outcomes:
measure: Antimicrobial Peptide
timeFrame: In the first 18 months of study
Secondary outcomes:
measure: Passive smoking measurement
timeFrame: In the first 18 months of study
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02682576: Brachial Artery Ultrasound Imaging: A Repeatability Study
Official title: Brachial Artery Ultrasound Imaging: A Repeatability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: brachial artery ultrasound imaging
flow-mediated dilation
endothelium
Lead sponsor: Everist Genomics, Inc
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 21
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: The objective of the study is to define the analytical repeatability of quantifying flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using upper arm cuff occlusion.


Eligibility criteria: Inclusion Criteria:

1. Men and women, ≥18 years old
2. Eastern Cooperative Oncology Group/Zubrod score performance status of 0, 1, or 2, determined within 7 days prior to FMD testing on Study Day 1 (Visit 1)
3. Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study

Exclusion Criteria:

1. Body mass index (BMI) \>50 kg/m2
2. Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>42 cm
3. Sinus arrhythmia (RR intervals vary by \>50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
4. Clinical signs and/or symptoms of active viral or bacterial infections
5. Resting tremor or inability to remain still for the duration of the testing period
6. Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
7. Diabetic subjects - Type I or II
8. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Primary outcomes:
measure: Change from baseline % flow-mediated dilation (%FMD) at 1 hour
timeFrame: 1 hour
Secondary outcomes:
measure: Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03
timeFrame: 1 day
Other outcomes:
Locations:
city: Derby
country: United States
facility: Yale University Prevention Research Center
state: Connecticut
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Everist Health
name: Peter F Lenehan, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04567576: Predictive Factors for COVID-19 in Rheumatology
Official title: Predictive Factors for COVID-19 in Rheumatology Study Based on Information Collected in The COVID-19 Global Rheumatology Alliance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatic Diseases
Covid19
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have a confirmed or suspected COVID-19 infection and have been treated at the Santa Fe de Bogotá University Hospital.

Brief summary: We seek to study the behaviour of Coronavirus infection in patients with rheumatological and/or autoimmune comorbidities, understood as a particular pathophysiological universe with its own risks and eventual benefits, until now fully hypothetical to be confirmed by means of real and recent evidence. On March 12, 2020, an initiative called the Global Alliance for COVID-19 in Rheumatology (The COVID-19 Rheumatology Alliance) arises, as a rapid response of international coordination whose ultimate goal is to serve as help or guideline for all those doctors who seek be faced with receiving, evaluating, understanding and caring for a patient with rheumatological and / or autoimmune diseases in relation to the imminent risk of COVID-19.

Detailed description: Within this context, this study seeks to use the information registered by the Fundación Santa Fe de Bogotá University Hospital as a participating centre. It is intended, under a prospective cohort methodology, to identify, analyze and compare predictive factors of the clinical course of COVID-19 in patients with baseline diagnoses of rheumatological or autoimmune diseases with the intention of establishing well-founded parameters that contribute to the improvement in terms of strategies of prevention, management and prognosis; benefiting both directly treating physicians and patients, as well as indirectly a health system that is predicted to be pushed to the limit as time passes.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years.
* Have a diagnosis of a rheumatological disease and / or an autoimmune disease by meeting its own and standardized classification criteria.
* Confirmed diagnosis of COVID-19 by RT-PCR test
* Being a patient at the Fundación Santa Fe de Bogotá University Hospital.
* Be enroled in the registry of the Global Alliance for COVID-19 in Rheumatology.

Exclusion Criteria:

• Loss of follow-up due to referral to an institution other than the Fundación Santa Fe de Bogotá University Hospital, before documenting the outcome of his clinical picture.

Primary outcomes:
measure: Clinical behavior of the disease // COVID-19
timeFrame: 1-12 weeks
measure: Mortality
timeFrame: 1-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06661876: Cardiac RadiothErapy For hEart faiLure
Official title: Cardiac RadiothErapy For hEart faiLure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Non-ischemic Cardiomyopathy
Ischemic Cardiomyopathy
Keywords: external beam radiotherapy
heart failure
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Preliminary data suggests that patients suffering from advanced refractory heart failure (HF) could benefit from single low dose whole heart external beam radiotherapy (EBRT).

Objective: To explore in our center the efficacy of administering a EBRT treatment of 5Gy to the whole heart in patients with advanced and refractory HF. The hypothesis is that 5Gy EBRT to the whole heart can improve the left ventricular ejection fraction (LVEF) of these patients by a clinically relevant 5%.

Main study endpoints: The primary aim is to explore the efficacy of EBRT treatment for advanced refractory HF. Secondary endpoints include an assessment of safety, overall survival, hospital admissions, late toxicity, quality of life and the effect of the treatment on other heart function indicators (left ventricular volumes, NT-proBNP, Troponine, High sensitive CRP).


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years
* Advanced refractory HF NYHA class II, III or IV
* Stable HF for the last 6 months with maximal guideline-directed HF therapy
* Ischemic or dilated cardiomyopathy
* LVEF at baseline ≤ 35%
* Ability to give a written informed consent and willingness to return for follow-up

Exclusion Criteria:

* Eligible or in consideration for heart transplantation
* Pregnancy or breastfeeding
* Previous radiotherapy with cardiac involvement
* Any condition that is deemed a contraindication in the judgment of the investigators

Primary outcomes:
measure: Change in left ventricular ejection fraction
timeFrame: Baseline, week 6, week 12, and 6 months
Secondary outcomes:
measure: Acute toxicity
timeFrame: toxicity occurring within 30 days after the radiation treatment.
measure: Late toxicity
timeFrame: 30 days to 6 months after the radiation treatment
measure: Quality of life - SF-36
timeFrame: Baseline, 6 weeks, 12 weeks, and 6 months
measure: Quality of life - MLWHF
timeFrame: Baseline, 6 weeks, 12 weeks, and 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: