louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01100567: Effect Of Biomechanical Stimulation On Skeletal Health In Adolescent And Young Women With Anorexia Nervosa
Official title: EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: skeletal health
bone turnover
bone geometry
malnutrition
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-04-09
Enrollment: 101
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of a novel, non-pharmacologic intervention for the prevention of deleterious changes in bone density and strength in adolescents with anorexia nervosa (AN), a disease commonly treated with extended periods of bed rest and immobilization. The primary focus of the trial is to conduct a prospective short-term intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and to determine the long-term effects of a biomechanical intervention on skeletal health in ambulatory adolescents with AN.


Eligibility criteria: Inclusion Criteria:

* Age 11-25 years
* Diagnosis of anorexia nervosa based on DSM-IV criteria
* Female gender
* English-speaking

Exclusion Criteria:

* • Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, celiac disease, renal disease, or diabetes mellitus

  * Use of medications known to affect bone metabolism in the last 3 months, such as:

    * Glucocorticoid therapy (including inhaled steroids)
    * Anticonvulsants
    * Combined estrogen/progestin contraceptive agents (oral contraceptive pills)
  * Depot medroxyprogesterone (Depo-Provera) use in the last 12 months
  * Current pregnancy

Primary outcomes:
measure: Change From Baseline in C-telopeptides
timeFrame: Baseline to 5 days
Secondary outcomes:
measure: Change From Baseline in Bone Specific Alkaline Phosphatase
timeFrame: baseline to 5 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Amy D DiVasta, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03756467: Girl Empower: Studying the Impact of Mentorship, Asset Building, Caregiver Discussion Groups, and Cash Transfers on Reducing Girl's Vulnerability to Sexual Exploitation and Abuse
Official title: Girl Empower: Studying the Impact of Mentorship, Asset Building, Caregiver Discussion Groups, and Cash Transfers on Reducing Girl's Vulnerability to Sexual Exploitation and Abuse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Behavior
Sexual Violence
Keywords: Adolescent Behavior
Sexual Violence
Lead sponsor: Population Council
Sponsor class: OTHER
Collaborators: name: World Bank
name: International Rescue Committee
name: City University of New York
First posted: 2018-11-28
Enrollment: 2200
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The impact evaluation study is a cluster-randomized controlled trial among 100 communities with three study arms: control (no intervention), GE, and GE+.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Girl Empower (GE) is a program designed to equip girls with the skills and experiences necessary to make healthy, strategic life choices and to stay safe from sexual exploitation and abuse.

Detailed description: The GE program is unique in its approach because it addresses girls' needs holistically. The girls' activities will take place in girl-only safe spaces located in their communities and contains the following components: Mentorship: girls have access to older female mentors. Mentors both provide weekly group-based and one-to-one interaction with girls as well as teach them critical skills; Asset building: Girls will have access to life skills and financial literacy training. This includes setting up savings accounts so girls practice their financial literacy skills, Monthly caregiver discussion groups among guardians of program girls, Capacity building and training of local health and psychosocial service providers to provide quality services to survivors of gender-based violence Intervention communities will either receive the GE program alone or the GE program with the plus small cash transfers to the girls' families as an incentive to attendance in weekly sessions (GE+).

Eligibility criteria: Inclusion Criteria:

* Healthy, eligible girls aged 13 to 14 years of age.

Exclusion Criteria:

-

Primary outcomes:
measure: Sexual Violence Index
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: Liberia
facility: University of Liberia
Study officials:
affiliation: Population Council
name: Kelly Hallman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06856967: Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
Official title: Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Synctial Virus Infections
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 138
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants \< 12 months during RSV 2024-2025 epidemic season

Brief summary: This study aims to evaluate the impact of Nirsevimab, a monoclonal antibody used for RSV prophylaxis, on reducing RSV- related hospitalizations. It will be conducted at 8 pediatric departments in Tuscany, Italy. First, a matched case-control study investigates the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations during the RSV epidemic season 2024-2025. Second, a descriptive study examines how the Nirsevimab immunization campaign affects RSV epidemiology, focusing on patients' age, comorbidities, infection severity, and clinical outcomes. The findings aim to optimize RSV prevention strategies and inform public health policies.


Eligibility criteria: Inclusion Criteria:

Case patients

* Age \<12 months
* Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
* Positive RSV PCR on nasopharyngeal swab Control patients
* Age \<12 months
* Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
* Hospitalized for conditions other than respiratory infections

Exclusion Criteria:

* Parental refusal
* Previous immunization with Palivizumab
* Previous maternal RSV vaccine immunization during pregnancy

Primary outcomes:
measure: The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.
timeFrame: November 2024-March 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Bagno a Ripoli
country: Italy
facility: SOC Pediatria Ospedale Santa Maria Annunziata
state: Firenze
city: Arezzo
country: Italy
facility: SOC Pediatria Ospedale San Donato
city: Firenze
country: Italy
facility: SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Pistoia
country: Italy
facility: SOC Pediatria e Neonatologia Ospedale San Jacopo
city: Prato
country: Italy
facility: SOC Pediatria e Neonatologia Ospedale Santo Stefano
city: Siena
country: Italy
facility: SOC Pediatria AOU Senese
Study officials:
References:
Clinical trial NCT06231667: The Effect of Health Literacy Education
Official title: The Effect of Health Literacy Education Given in Early Adolescence on Adolescents' Health Literacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy Level
Keywords: health literacy
education
adolescent
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study was conducted with a parallel group randomized controlled experimental design to evaluate the effect of health literacy education given in early adolescence on the health literacy of adolescents. The population of the study consisted of 6th and 7th grade (12-13 years old) students studying in a secondary school in Ankara. Power analysis was used to determine the sample size. A total of 80 adolescents who met the inclusion criteria were included in the sample.


Eligibility criteria: Inclusion Criteria:

* Consent by the student's family
* Volunteering to participate in the research
* Having a low level of health literacy

Exclusion Criteria:

* Read and write Turkish
* Have a moderate or high level of health literacy
* Physical/mental disability or illness

Primary outcomes:
measure: Health Literacy Level (School Age Children Health Literacy Scale)
timeFrame: before the implementation
measure: Health Literacy Level (School Age Children Health Literacy Scale)
timeFrame: one month after the education
measure: Health Literacy Level (School Age Children Health Literacy Scale)
timeFrame: three month after the education
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT04923867: Suturable DuraGen™ PMCF Study
Official title: A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrospinal Fluid Leak
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2021-06-11
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurosurgery service in Hospital

Brief summary: The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.

Detailed description: This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF) leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a supratentorial, infratentorial, or spinal procedure.

Eligibility criteria: Inclusion Criteria:

1. Subject is between 18 and 80 years of age
2. Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
3. Availability of post-operative assessment results.

Exclusion Criteria:

1. There are no exclusionary criteria for this study population

Primary outcomes:
measure: Patient Outcome
timeFrame: post-up to 90 days
Secondary outcomes:
measure: Occurrence of Adverse Event
timeFrame: Between days 30-90
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Portland
country: United States
facility: Oregon Health &amp; Science University
state: Oregon
Study officials:
affiliation: Integra LifeSciences
name: Andrew Tummon
role: STUDY_DIRECTOR
References:
Clinical trial NCT00891267: Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
Official title: Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Hypertension
Keywords: Inflammatory markers
Vascular protection
OM Effect
Metabolic syndrome
Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation
* Blood pressure greater than or equal to 130/85 mmHg AND
* hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria):
* abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women;
* triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women
* fasting blood glucose greater than or equal to 110mg/dL

Exclusion Criteria:

* Insulin depended diabetes or type-1 diabetes
* Severe or resistant hypertension
* Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
* Any acute or chronic inflammatory disease
* Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start
* Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception);
* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)

Primary outcomes:
measure: To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP
timeFrame: 6 weeks for each treatment
Secondary outcomes:
measure: To evaluate the additional antihypertensive efficacy in blood pressure (BP) lowering, assessed by conventional BP measurement and 24-h ambulatory BP measurement (24-h ABPM)
timeFrame: 6 weeks for each treatment
Other outcomes:
Locations:
city: Erlangen
country: Germany
Study officials:
References:
Clinical trial NCT01053767: A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine
Official title: A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotypes Ib and III Antibodies in Women Previously Immunized With a GBS Ib and III Crm-Glycoconjugate Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Group B Streptococcus (GBS) Disease
Keywords: Group B streptococcus
GBS
Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-01-21
Enrollment: 95
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study looks at the body's immune response to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody levels.


Eligibility criteria: Inclusion Criteria:

* Individuals who have given written consent.
* Individuals who participated in V98P2 and received the complete schedule of vaccinations.

Exclusion Criteria:

* Individuals who have not given written consent.
* Subjects who did not receive the complete schedule of vaccination in V98P2.

Primary outcomes:
measure: Antibody (Ab) response data at 24-months after the last injection given in study V98P2 GMCs, GMRs and associated 95% confidence intervals will also be determined.
timeFrame: 24- months post last injection from V98P2
Secondary outcomes:
Other outcomes:
Locations:
city: Via Mastri, 36
country: Switzerland
facility: Institute for Pharmacokinetic and Analytical Studies
state: CH - 6853 Ligornetto
Study officials:
References:
Clinical trial NCT01190267: Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)
Official title: A 26-week, Multi-center, Open-label, Flexible Dose, Long-term Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia, Paranoid
Schizophrenia, Disorganized
Schizophrenia, Undifferentiated
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 204
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is generally safe and well tolerated in adolescents with schizophrenia. This is an extension of base study P05896 (NCT01190254), which means participants must have completed participation in the 8-week base study in order to qualify for this extension study P05897. Participants in this extension study will receive open-label asenapine for 26 weeks. Throughout the study, observations will be made on each participant at various times to assess the long-term safety, tolerability and efficacy of the study treatment.


Eligibility criteria: Inclusion Criteria:

* Each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (P05896 \[NCT01190254\]) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met.
* Must have completed the 8-week efficacy and safety trial (P05896 \[NCT01190254\]) and, according to the investigator's judgment, would benefit from long-term treatment.
* Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 \[NCT01190254\]), in the opinion of the investigator.

Exclusion Criteria:

* A female participant must not be pregnant and must not have the intention to become pregnant during the trial.
* A participant must not be at imminent risk of self-harm or harm to others.
* A participant must not currently be under involuntary inpatient commitment.

Primary outcomes:
measure: Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study
timeFrame: Up to 30 weeks
measure: Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE
timeFrame: Up to 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Findling RL, Landbloom RP, Mackle M, Pallozzi W, Braat S, Hundt C, Wamboldt MZ, Mathews M. Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia. J Child Adolesc Psychopharmacol. 2015 Jun;25(5):384-96. doi: 10.1089/cap.2015.0027.
Clinical trial NCT02597140: Pilot Study of Effect of Intravenous Lidocaine on Propofol Requirement in Facial Plastic Surgery
Official title: Pilot Study of Effect of Intravenous Lidocaine on Propofol Requirement During Monitored Anesthesia Care in Facial Plastic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Intravenous; Surgery, Plastic
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this randomized pilot study is to evaluate the effect of intravenous lidocaine on propofol requirement during BIS (Bispectral index) guided MAC (monitored anesthesia care) in facial plastic surgery.

Detailed description: Several studies reported the usefulness of intravenous lidocaine as a coadjuvant agent during general anesthesia. We thought that there would be an interaction between intravenous lidocaine and hypnotic agent requirement. However, there is no data regarding the effect of systemic lidocaine during MAC. We, thus, would like to perform a randomized, double-blinded pilot study to evaluate the effect of intravenous lidocaine on propofol requirement during BIS guided MAC in facial plastic surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status classification 1 or 2 patients
* aged 20-65 years who were undergoing elective facial plastic surgery under monitored anesthesia care

Exclusion Criteria:

* unwillingness to participate in the study
* adverse reaction to the drugs used in the study
* use of medications that interfere in local anesthetic metabolism
* history of liver disease or kidney failure
* neurological or psychiatric disease
* history of drug or alcohol abuse
* chronic use of benzodiazepine

Primary outcomes:
measure: total propofol requirements
timeFrame: during monitored anesthesia care
Secondary outcomes:
measure: postoperative pain
timeFrame: 30 minutes, 2 hours, and 4 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
Clinical trial NCT00989040: Impact of Neuropathic Post-Zosterian Pain on the Cognition
Official title: Impact of Neuropathic Post-zosterian Pain on the Cognition (NPZ and Cognition)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Post-zosterian Pain
Cognition
Keywords: NPZ
Pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2009-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who suffer of neuropathic post-zosteria pain

Brief summary: Pain is defined as a sensorial and emotional phenomenon and lead consequences on the cognition. These consequences could be increased with usual treatment. So the aim of this study is to explore these cognitive consequences.

Detailed description: Pilot prospective study with parallel groups

Eligibility criteria: Inclusion Criteria:

* Patient suffering of NPZ pain
* Over 55 years old
* Healthy volunteers

Primary outcomes:
measure: The principal outcome is to explore if the cognition is failed in treated patients suffering of neuropathic post-zosteria pain.
timeFrame: at day 1
Secondary outcomes:
measure: Study if treated patients with patch (Versatis®) have better cognition than treated patients without patch.
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: CIC-CPC Clermont-Ferrand
name: Claude Dubray, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pickering G, Pereira B, Clere F, Sorel M, de Montgazon G, Navez M, Picard P, Roux D, Morel V, Salimani R, Adda M, Legout V, Dubray C. Cognitive function in older patients with postherpetic neuralgia. Pain Pract. 2014 Jan;14(1):E1-7. doi: 10.1111/papr.12079. Epub 2013 May 23.