louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02102048: ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to Atazanavir
Official title: ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to Boosted or Unboosted Atazanavir
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: HIV
diabetes
glucose metabolism
antiretroviral therapy
ritonavir
atazanavir
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The association between HIV infection , insulin resistance and diabetes mellitus is the topic of many studies that have attempted to analyze the problem from different points of view. In fact, the risk of insulin resistance in HIV-positive patients on antiretroviral therapy seems to depend not only on the same factors that determine its incidence in the general population , but also on the effects of antiretroviral therapy on glucose metabolism. To confirm this observation, studies that have evaluated the incidence of diabetes in patients with HIV infection on antiretroviral therapy have shown that the incidence of diabetes in infected individuals is significantly higher than that observed in the uninfected population. Moreover others preliminar stadies observed that protease inhibitors may induce hyperglycemia and diabetes mellitus. Anyway at this moment no large data are available that indicate the utility to modify the antiretroviral therapy in HIV positive patients with a damage of glucose metabolism.

ATAGLU is a cohort composed by HIV positive patients in effective and stable combined antiretroviral therapy (cART) with undetectable viral load. All patients studied had carried out a therapy with Lopinavir/Ritonavir (LPV/r) + optimal backbone therapy (OBT) and then in part switch to Atazanavir (ATV) + OBT or Atazanavir/ritonavir (ATV/r) + OBT , in part continue with LPV/r + OBT .

The objective was to characterize the changes of carbohydrate profile of a cohort of patients who made a switch from a regimen with LPV/r to boosted or unboosted ATV.


Eligibility criteria: Inclusion Criteria:

* HIV postive patients
* Patients on stable and effective antiretroviral therapy with a Protease Inhibitor

Exclusion Criteria:

* use of Atazanavir before the enrolment
* pregnancy

Primary outcomes:
measure: Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value
timeFrame: 1 year
Secondary outcomes:
measure: insulinemia
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)
Study officials:
affiliation: University of Rome "Sapienza" (Italy)
name: Vincenzo Vullo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01736748: Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors
Official title: Implementing Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obese
Keywords: obesity
physical activity
metabolism
environment
obese children, as defined by a body mass index > 95th percentile
for age and sex
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Dyn@mo lifestyle intervention (CHU Sainte-Justine, Quebec, Canada) targets children and adolescents aged 6 to 17 years old with cardiometabolic risk factors, such as obesity, hypertension, disorders in glucose regulation or dyslipidemia. Its primary goal is to promote physical activity and reduce sedentary time to improve childrens' cardiometabolic profile. To do so, the intervention relies on gathering data on mobility and physical activity using wearable sensors. These data provide a detailed picture of real-life conditions and physical activity levels, improving the health care professional's ability to tailor counseling. The investigators are presently in the implementation phase of this intervention.


Eligibility criteria: Inclusion Criteria:

* children ages 6 to 18 years of age with a BMI \> 95th percentile for age and sex

Exclusion Criteria:

* children with a physical or psychological condition that would impair their ability to participate in physical activity

Primary outcomes:
measure: Change in physical activity levels
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline and 1 year
measure: Change in glucose homeostasis
timeFrame: Baseline and 1 year
measure: Change in lipid status
timeFrame: Baseline and 1 year
measure: Change in body mass index
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT03499548: The INSPiRe Programme: Developing an Intensive Suicide Prevention Therapy for Suicidal Prisoners
Official title: The INSPiRe Programme: A Feasibility and Acceptability Study of Intensive Suicide Prevention Therapy in Prison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Intensive
Cognitive Behavioral Therapy
Male prisoners
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 13
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the acceptability and feasibility of a short-term, intensive Cognitive Behavioural Therapy (CBT) delivered to male prisoners who have thoughts of ending their lives.

Detailed description: 10 hours of an adapted CBT therapy for suicide will be delivered across 2 weeks in 5 2 hour sessions to male prisoners. They will initially be assessed on several measures of mood, social support and suicidality. They will then undergo therapy. Following this they will be asked to re-completed the initial measures and a post-therapy interview to ascertain their thoughts on their experience of the therapy.

Eligibility criteria: Inclusion Criteria:

* Aged over 21 years old.
* Has been managed under the Assessment, Care in Custody, and Teamwork (ACCT) system within the last 1 month (including current ACCT review).
* Sufficient English language proficiency, as judged by the researcher, in order to complete psychometric questionnaires (i.e. adequate reading comprehension) and engage in intensive CBT programme (i.e. adequate verbal communication).
* Adult is able to provide informed consent as established during baseline clinical interview (BPS, 2006; MCA, 2005).
* Currently residing in HM Prison (and expected to remain there for at least six weeks; determined through staff and prisoner report).

Exclusion Criteria:

* A primary organic disorder (indicated by prison medical staff report or records).
* Any current risk behaviour which would compromise the safety of others, as identified by prison staff.

Primary outcomes:
measure: The Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 20 minutes
measure: Therapist Session Summary
timeFrame: 5 minutes
measure: Discharge summary sheet
timeFrame: 15 minutes
measure: Therapist Rating Form
timeFrame: 20 minutes
measure: Post-intervention interview
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Warrington
country: United Kingdom
facility: HMP Risley
state: Greater Manchester
Study officials:
affiliation: University of Manchester
name: Daniel Pratt
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Yvonne Awenat
role: STUDY_CHAIR
affiliation: University of Manchester
name: Charlotte Lennox
role: STUDY_CHAIR
References:
Clinical trial NCT00887848: Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy
Official title: Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Child
Robotic-assisted treadmill training
Rehabilitation
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: Reha Rheinfelden
First posted: 2009-04-24
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effectiveness of robotic-assisted locomotor therapy on improvements of functional gait parameters in ambulatory children with cerebral palsy.

Detailed description: Within a randomized controlled design the effects of robotic-assisted locomotor training (15 sessions within 5 weeks) will be examined in a sample of 34 children with cerebral palsy.

Children will be randomly assigned to an intervention or waiting list group. Assessments will be performed at baseline, in week 6 as well as in week 12. The intervention is provided to the waiting list group after the assessment in week 6.

Eligibility criteria: Inclusion Criteria:

* Bilateral spastic cerebral palsy
* Gross Motor Function Classification Scale (GMFCS) II-IV

Exclusion Criteria:

* Prior orthopedic surgery on the lower extremity or the trunk (\<6 months)
* Prior neurosurgical interventions (\<6 months)
* Significant mental retardation
* Severe contractures
* Prior Lokomat training (\<6 months)

Primary outcomes:
measure: GMFM-66, section E
timeFrame: week 0, week 6, week 12
Secondary outcomes:
measure: GMFM-66, section D
timeFrame: week 0, week 6, week 12
measure: Gait speed
timeFrame: week 0, week 6, week 12
measure: 6-minute walk test
timeFrame: week 0, week 6, week 12
measure: 3D gait analysis
timeFrame: week 0, week 6
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Paediatric Therapy Center Reha Rheinfelden
state: Aargau
city: Affoltern am Albis
country: Switzerland
facility: University Children's Hospital Zurich, Rehabilitation Centre Affoltern
Study officials:
affiliation: University Children's Hospital Zurich, Rehabilitation Center Affoltern
name: Corinne Ammann-Reiffer, MPTSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ammann-Reiffer C, Bastiaenen CHG, Meyer-Heim AD, van Hedel HJA. Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT). J Pediatr Rehabil Med. 2020;13(2):137-148. doi: 10.3233/PRM-190614.
citation: Ammann-Reiffer C, Bastiaenen CH, Meyer-Heim AD, van Hedel HJ. Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT). BMC Pediatr. 2017 Mar 2;17(1):64. doi: 10.1186/s12887-017-0815-y.
Clinical trial NCT04148248: A Pilot Study to Explore the Role of Gut Flora in Chronic Constipation
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Constipation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Constipation
Constipation Chronic Idiopathic
Constipation - Functional
Constipation (Excl Faecal Impaction)
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and minors of any age with a diagnosis of chronic constipation.

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding chronic constipation

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding chronic constipation.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers)
3. Diagnosis of chronic constipation

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03535948: Elderly Hodgkin Lymphoma Patients Treated With Chemoradiotherapy
Official title: Outcome of Hodgkin Lymphoma Patients Over Than 60 Years Treated by Chemotherapy and/or Radiotherapy: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hodgkin Lymphoma, Adult
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Hodgkin lymphoma patients over 60 years treated between 2000 and 2013 by chemotherapy and/or radiotherapy in two university hospitals in France

Brief summary: Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or radiotherapy: retrospective analysis.


Eligibility criteria: Inclusion Criteria:

* Patients over than 60 years
* Newly diagnosed Hodgkin lymphoma

Exclusion Criteria:

* Data not available

Primary outcomes:
measure: Progression-free survival
timeFrame: Time between diagnosis and progression or death - up to 100 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Lauriane Filliatre-Clement
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02286648: Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulpitis
Dental Pulp Disease
Tooth Diseases
Keywords: clinical signs
child
pulpotomy
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.


Eligibility criteria: Inclusion Criteria:

* healthy people(without any systemic disease)
* teeth :

  * no clinical or radiographic evidence of pulp degeneration
  * the possibility of proper restoration of the teeth

Exclusion Criteria:

* teeth :

  * excessive bleeding from the exposure site
  * internal root resorption
  * interradicular and/or periapical bone destruction
  * swelling or sinus tract

Primary outcomes:
measure: successful outcome of treatment as indicated by clinical signs defined with observation and check list
timeFrame: up to 12 months
Secondary outcomes:
measure: successful outcome of treatment as indicated by radiographic signs defined with observation and check list
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Siences
state: Khorasan Razavi
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Siences
state: Khorasan Razavi
Study officials:
References:
Clinical trial NCT03153748: New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population
Official title: New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Keywords: Treatment strategy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presented with subarachnoid hemorrhage and diagnosed with ruptured aneurysm at all age.

Brief summary: This study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the treatment strategy between interventional treatment and open surgery, so as to improve the diagnosis and treatment of aneurysmal SAH.


Eligibility criteria: Inclusion Criteria:

* patients presented with subarachnoid hemorrhage on CT or lumbar puncture.
* the intracranial hemorrhage was caused by rupture of aneurysm and was confirmed on CTA、MRA or DSA.
* patients willing to participate in this clinical trial and attach to regular follow up.

Exclusion Criteria:

* intracranial aneurysm correlating to AVM.
* dissection, false, traumatic and infectious aneurysms.
* the rupture of the aneurysm can not be confirmed on CTA、MRA or DSA.
* patients unwilling to participate in this clinical trial and attach to regular follow up.

Primary outcomes:
measure: mRS score
timeFrame: 1 year after treatment
measure: cure rate
timeFrame: 6 months after treatment
Secondary outcomes:
measure: recurrence rate
timeFrame: through study completion, an average of 1 year
measure: complication rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Qinghai Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02532348: Platelets Study: Influence of the Antiretroviral Treatment on the Platelet Physiology During HIV Infection
Official title: Platelets Study: Influence of the Antiretroviral Treatment on the Platelet Physiology During HIV Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus
HIV
antiretroviral therapy
platelets
Immune activation
Inflammatory state
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 133
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: Study populations:

* HIV patients under 2 NRTIs (Nucleosidic analogs of Transcriptase Reverse Inhibitors) and 1 PI or 2 NRTIs and 1 NNRTI, for at least one year with a plasmatic viral load under 40 cp/ml.
* Untreated HIV patients

Brief summary: HIV infection is associated with an immune activation and an inflammatory response - despite an active antiretroviral therapy - which may lead notably but not exclusively to cardiovascular diseases. It has been shown that the use of Protease Inhibitors (PI) instead of Non Nucleosidic Inhibitors (NNRTI) may increase the risk of myocardial infarction. Platelets may play a role in the occurrence of the inflammatory state: they contain big amounts of chemokines, growth factors, and adhesion proteins. Today, the contribution of platelets to the inflammatory state associated with HIV infection has been little studied. Thus, it has been shown that platelets in HIV patients are able to release interleukin (IL)-18. The group has shown with others that the platelet function could be altered during HIV infection. Inversely, it doesn't know how antiretroviral therapy interacts with platelets.

The aim of the study is to evaluate, according to the antiretroviral therapy, the impact on the platelets activation markers.


Eligibility criteria: Inclusion Criteria:

* Unchanged antiretroviral therapy for at least one year
* Plasmatic viral load \< 40 copies/ml.
* signature of informed consent

Exclusion Criteria:

* Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HVC) coinfection

Primary outcomes:
measure: Plasmatic level of sCD40L
timeFrame: day 1
Secondary outcomes:
measure: sCD40L level
timeFrame: day 1
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Frédéric Lucht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02861248: Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatrix
Keywords: Burn Scar
Micro-plasma Radiofrequency Therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 95
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective study to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population.

Detailed description: Background: Laser therapy is an emerging, minimally invasive treatment for scars. Among the various techniques, fractional microplasma radiofrequency technology (FMRT) has proved to be effective for various types of scars and skin conditions such as rhytids, striae distensae, and hyperpigmentation.

Method: A prospective clinical trial was conducted to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population. All patients underwent three to five treatment sessions at intervals of 8-16 weeks. The patient and observer scar assessment scales (POSAS) were use to evaluate changes in the burn scars before and after treatment. Intermediate and long-term adverse events were recorded for outcome analysis.

Eligibility criteria: Inclusion Criteria:

* patients with ≥1-year-old non-hypertrophic burn scars

Exclusion Criteria:

* pregnancy or breastfeeding
* history of hypertrophic scars or keloids
* abnormal medical examination including routine blood count, liver and kidney functions and immune function
* history of treatment including surgery, dermabrasion, laser treatment within the past 6 months
* the presence of a cardiac pacemaker or other metallic implant near the treatment site.

Primary outcomes:
measure: POSAS score
timeFrame: From baseline to 6 months after final treatment
Secondary outcomes:
measure: Complications
timeFrame: From baseline to 6 months after final treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Laser division of Plastic Surgery Department, Shanghai 9th people's hospital
Study officials:
References: