louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02547727: Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults
Official title: Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rabies
Keywords: rabies vaccination
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
First posted: 2015-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.

Detailed description: A four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons. So, the investigators hypothesized the same outcome in HIV - infected patients.

Eligibility criteria: Inclusion Criteria:

* HIV infected patients
* Age 18 - 60 years
* Received primary rabies immunization

Exclusion Criteria:

* Have any active opportunistic infections
* Received blood or blood product within 3 months
* Allergy to vaccine or any vaccine components
* Received anti-malarial drugs

Primary outcomes:
measure: Rabies neutralizing antibody titers
timeFrame: Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks
Secondary outcomes:
measure: Specific T cell response
timeFrame: Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks
measure: Cytokines assessment
timeFrame: Change from baseline of cytokines levels at 1 week
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute, Thai Red Cross Society
Study officials:
affiliation: Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university
name: Suda Sibunruang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06215027: The Effects of Dance for Breast Cancer Patients Undergoing Surgical Treatment
Official title: Os Efeitos da dança Como Recurso terapêutico em Pacientes Com câncer de Mama Submetidas a Tratamento cirúrgico
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: AC Camargo Cancer Center
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this non randomized clinical trial, with pre- and post-intervention evaluation, longitudinal, with prospective data collection is to evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment.

Detailed description: The hypothesis is that dance will promote improvements in range of motion, strength, fatigue, functionality, pain and quality of life for breast cancer patients undergoing surgical treatment. Objectives: To evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment on: shoulder range of, overall muscle strength, fatigue, respiratory muscle strength, functionality, pain and quality of life. Method: This is a non-randomized randomized clinical trial, with pre- and post-intervention evaluation, prospective data collection. The following will be used for pre-intervention assessment: goniometry, dynamometry, manovacuometry, 6-minute walk test, fatigue and quality of life questionnaire, and quality of life questionnaire, as well as a pain assessment scale. After 16 weeks, the same variables will be assessed.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with breast cancer
* undergone surgical resection
* after medical referral for physiotherapy
* and physiotherapeutic assessment

Exclusion Criteria:

* patients with another previous oncological diagnosis
* previous neuromuscular diseases
* patients who do not agree to take part in the study
* or the impossibility of carrying out the muscle strength assessment and/or other assessments

Primary outcomes:
measure: ROM
timeFrame: Pre-intervention and after 16 weeks
Secondary outcomes:
measure: Overall muscle strength
timeFrame: Pre-intervention and after 16 weeks
measure: Fatigue
timeFrame: Pre-intervention and after 16 weeks
measure: respiratory muscle strength
timeFrame: Pre-intervention and after 16 weeks
measure: Functionality
timeFrame: Pre-intervention and after 16 weeks
measure: Pain intensity
timeFrame: Pre-intervention and after 16 weeks
measure: Quality of life (physical well-being, social and family well-being, emotional well-being, functional well-being)
timeFrame: Pre-intervention and after 16 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: AC Camargo Cancer Center
Study officials:
affiliation: AC Camargo Cancer Center
name: Letícia Cardenas, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00924573: Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
Official title: Double-blinded Comparative Study to Investigate the Efficacy and Safety of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride in Patients With T2DM Inadequately Treated With Constant Dose of Glimepiride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Glimepiride
Metformin
Combination Drug Therapy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 189
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective of this study is to confirm the efficacy of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change.

Secondary objectives of this study is to evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters

Detailed description: Patients treated with 2-6mg/day of glimepiride will be recruited. The study period consists of screening phase of 6 weeks and double-blinded phase of 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus patients treated with constant dose of glimepiride on top of diet and exercise
* Patients who gave informed consent to participate in the study

Exclusion Criteria:

* Patients with HbA1c of \< 7.0 % and \> 11.0 %
* Patients with any following laboratory test abnormality :

  * ALT and/or AST: \> 3 X ULN
  * Neutrophils: \< 1,000/mm3 and/or platelets \< 100,000/mm3
  * Hemoglobin: \<11 g/dL
  * Creatinine: \>= 1.3 mg/dL in case of male or \>= 1.0 mg/dL in case of female

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Changes in HbA1c from baseline
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in the ratio patients with < 7.0% of HbA1c
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Kawasaki Medical University
name: Kaku Kohei, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05383573: Pediatric ANCA Associated-vasculitis
Official title: Pediatric ANCA Associated-vasculitis : Latest Clinical Review and Therapeutic Outcomes. A Retrospective Epidemiological Study on a French Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ANCA-Associated Vasculitis
Keywords: ANCA-Associated Vasculitis
Pediatric ANCA
Vasculitis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor subject (\<18 years old) with diagnosis of ANCA vasculitis according to the international criteria for defining the pathology, GPA or MPA form between 2011 and 2020.

Brief summary: The incidence in pediatrics is very low (about 0.5 per million according to a French study) and therefore the data on the pathology very poor, especially on the therapeutic level.

Without appropriate treatment, the mortality rate of the pathology is very high.

Existing treatments are almost exclusively composed of immunomodulatory and/or immunosuppressive treatments.

Complications related to pathology and iatrogeny are among the first causes of mortality from this pathology and deserve to be studied in order to be known and if possible avoided. The purpose of the study is to achieve a national comparison of clinical and therapeutic practices.


Eligibility criteria: Inclusion criteria:

* Minor subject (\<18 years old)
* Diagnosis of ANCA vasculitis according to the international criteria for defining the pathology, GPA or MPA form between 2011 and 2020.
* Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject (or his parents) having expressed his (their) opposition to participating in the study
* Patients with vasculitis has ANCA in the form of EGPA
* Associated pathologies that cannot be related to the diagnosis of ANCA vasculitis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.

Primary outcomes:
measure: Retrospective study of clinical and therapeutic practices at the national level.
timeFrame: Files analysed retrospectively from January 01, 2011 to December 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00664573: 104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants
Official title: Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Safety
Rheumatoid Arthritis
Baminercept alfa
Methotrexate
BG9924
Efficacy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.


Eligibility criteria: Inclusion Criteria:

* Must be a participant from Study 104RA202 (NCT 00664716)
* Stable dose of Methotrexate for the duration of the study

Exclusion Criteria:

* Participants with a significant change in their medical history from their previous BG9924 study
* Any clinically significant infectious illness or serious local infection

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: To Observe The Long-Term treatment with BG9924 When Administered to Participants with RA who Previously Participated in a Biogen Idec Study
timeFrame: Duration of this study is 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucuman
country: Argentina
facility: Coordinating Research Site
city: Sao Paulo
country: Brazil
facility: Coordinating Research Site
city: Budapest
country: Hungary
facility: Coordinating Research Site
city: Cuernavaca
country: Mexico
facility: Coordinating Research Site
city: Torun
country: Poland
facility: Coordinating Research Site
city: Braila
country: Romania
facility: Coordinating Research Site
city: Moscow
country: Russian Federation
facility: Coordinating Research Site
city: Leeds
country: United Kingdom
facility: Coordinating Research Site
state: Yorkshire
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03992573: CGF Influence on Post-operative Complications.
Official title: The Influence of Concentrated Growth Factors (CGF) Application on Post-operative Complications.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CGF
Bone Loss
Post-operative Wound Healing
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the influence of CGF application into post-operative soft tissue and bone defects on post-operative complications and wound healing.

Detailed description: The research was conducted in twenty patients with symmetric single tooth qualified to extraction. On one side of dental arch, post-operative region was field with CGF material, while on the other side it was left to normal healing. In both cases pain, swelling, alveolar osteitis, antibiotics and analgesics intake in post-operative period were evaluated in the first, fourth and seventh day after surgery. Wound healing was assessed seven and thirty days after extraction.

Eligibility criteria: Inclusion Criteria:

* no known medical history of abnormal platelet counts,
* patients with symmetric teeth qualified for extraction,

Exclusion Criteria:

* systemic diseases,
* pregnancy,
* lactation,
* drugs known to affect the number or function of platelets,
* abnormal platelet counts

Primary outcomes:
measure: Intensity of pain vs. CGF application
timeFrame: 24 hours
Secondary outcomes:
measure: Occurrence of swelling
timeFrame: 24 hours
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Oral Surgery
Study officials:
References:
Clinical trial NCT01058473: Psychometric Evaluation of the IPPAQ in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain
Official title: Psychometric Evaluation of the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ) in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Pain
Keywords: Sickle Cell Disease
Pain
Assessment
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 159
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, adolescents, and young adults with sickle cell disease.

Brief summary: Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of its recurrent nature. Patients with sickle cell disease may be hospitalized for extended periods of time. As the hospital stay progresses, patients with SCD pain are often observed by clinicians to have improvements in function in areas such as self-care, mobility, and recreation despite continued self-report of high pain scores. This pattern of functional improvement with continued report of high pain intensity scores is common in patients with recurrent and chronic pain. A functional assessment tool that can assess function in the acute inpatient setting is needed.

The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease hospitalized with vasoocclusive pain.

Detailed description: Refer to Brief Summary

Eligibility criteria: Inclusion Criteria:

* Documented sickle cell disease
* Sudden onset of pain consistent with vasoocclusive episode at the time of hospitalization.
* Pain requiring hospitalization and placement on standard clinical guideline for management of acute pain in sickle cell disease during hospitalization
* Cognitive ability to report pain on a 0-10 Numerical Rating Scale (NRS)
* Parental/patient consent and child assent

Exclusion Criteria:

* Primary diagnosis other than vasoocclusive pain
* Concurrent Acute Chest Syndrome (ACS)
* Patient previously enrolled in this study
* Inability to understand English

Primary outcomes:
measure: IPPAQ
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: William T. Zempsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04118673: Secondary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (S-PLAC 2)
Official title: Secondary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (Phase II)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Health Behavior
Lead sponsor: University of South Wales
Sponsor class: OTHER
Collaborators: name: Public Health Wales
name: Cwm Taf University Health Board
First posted: 2019-10-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study is an interventional controlled observational study based in the Secondary care setting. Control groups will be utilized through the mechanism of wait-listing the enrolment of recruitment centres into the study.

Mixed methods will be used for both data collection and analysis. Historical clinical participant data (pre-intervention) will be collected by the PI. data will be collected immediately after the consultation and at 3 months post intervention.
Primary purpose: PREVENTION

Brief summary: Prescribing lifestyle changes to patients who have cardiovascular disease (CVD) may be an extremely cost effective mechanism of improving health individually and for the NHS. Positive lifestyle changes such as improved diet, increased physical activity, quitting smoking and reducing alcohol consumption have been proven to reform the health status of individuals with CVD. S-PLAC 2 is a phase II study to determine the efficacy of a lifestyle prescription (L℞) in patients and healthcare practitioners in a secondary care setting (i.e. hospital clinics/wards).


Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Able and willing to provide written informed consent
* Understands written and spoken English
* Either an in/out- patient of Cardiology

Exclusion Criteria:

* Participant is unwilling or unable to provide written informed consent
* Participant is pregnant
* Participant has a drug dependency

Primary outcomes:
measure: A prescription (LRx) being issued during a consultation
timeFrame: During month 7 of the study
measure: Patient view of the prescription (LRx) and consultation Questionnaire
timeFrame: During month 7 of the study
measure: Healthcare practitioner (HCP) view of the prescription (LRx) and consultation questionnaire.
timeFrame: During month 7 of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Pontypridd
country: United Kingdom
facility: University of South Wales
Study officials:
References:
Clinical trial NCT01617473: Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant
Official title: Randomized Trial of Unmanipulated Mobilized Blood/Marrow Versus Blood Haploidentical Transplant With Standard-risk Leukemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Leukemia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The use of peripheral blood stem cells(PBSCs) is rapidly growing in the allogeneic transplantation setting as an alternative to bone marrow (BM).It was found that the use of PBSCs is associated with faster hematologic recovery but have yielded differing results regarding the incidence of graft-versus-host-disease (GVHD) and relapse.

The study hypothesis:

transplantation of mobilized PBSC to haploidentical donor with standard-risk leukemia had comparable engraftment and non-relapse mortality to mobilized BM combined with PBSCs

Detailed description: The donors were primed with granulocyte-colony stimulating factor (G-CSF) injected subcutaneously for five consecutive days. In the trial group, the PBSCs were harvested on the fourth and fifth day;in the control group, the bone marrow cells were harvested on the fourth day and the PBSCs were harvested on the fifth day.

Eligibility criteria: Inclusion Criteria:

* Standard risk of Recipients of haploidentical stem cell transplantation with myeloablative conditioning regimens

Exclusion Criteria:

* Active, uncontrolled infection

Primary outcomes:
measure: incidence of engraftment
timeFrame: paticipants will be followed for the duration of hospital stay,an expected average of 30 days
Secondary outcomes:
measure: incidence of non-relapse mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People'S Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Xiao-Jun Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: