louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00856154: Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection
Official title: Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection. Phase I Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV-1
HLA-A2
Therapeutic
Vaccine
treatment vaccine
treatment naive
Lead sponsor: Statens Serum Institut
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: Rigshospitalet, Denmark
First posted: 2009-03-05
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I test of concept study: In an attempt to induce new immunity to HIV-1 during untreated HIV-1 infection the investigators have identified relatively immune silent immune subdominant HLA-A2-restricted HIV-1 CTL epitopes that fit individuals with the HLA-A2 tissue type (about 50% of peoples in Denmark). Immunising with these conserved epitopes could induce new immunity and lower viral load so the patient will live longer before AIDS or Antiviral medicine and a lower viral load will limit spread in the population. As adjuvants the investigators used patients' own autologous Dendritic Cells generated from blood cells in vitro. 12 healthy male HIV-1 infected not in therapy individuals were used for this therapeutic vaccination and tested for safety and induction of new cellular CD8 and CD4 T-cell immunity.


Eligibility criteria: Inclusion Criteria:

* HIV positive male
* Viral load \>1000/ml
* CD4 count \>300
* HLA-A2 tissue type
* 18-50 years of age
* Able to follow the instructions
* Informed consent

Exclusion Criteria:

* Treated with other experimental vaccines or immune modulatig medicine
* Other chronic infectious diseases
* Allergy or autoimmune disease

Primary outcomes:
measure: Safety: no changes in the blood Hemoglobin, leucocytes, trombocytes, serum sodium,potassium,creatinine,phosphatase, ALAT,ASAT, bilirubin,CRP. No dose limiting toxicity defined as unwanted events defined by CTC version 3 definition as greade 3 or more.
timeFrame: 12 months
Secondary outcomes:
measure: Cellular Immunity induction
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Statens Serum Institut
name: Anders Fomsgaard, MD DMSc
role: STUDY_CHAIR
References:
citation: Thorn M, Tang S, Therrien D, Kloverpris H, Vinner L, Kronborg G, Gerstoft J, Corbet S, Fomsgaard A. Sequence conservation of subdominant HLA-A2-binding CTL epitopes in HIV-1 clinical isolates and CD8+ T-lymphocyte cross-recognition may explain the immune reaction in infected individuals. APMIS. 2007 Jun;115(6):757-68. doi: 10.1111/j.1600-0463.2007.apm_595.x.
Clinical trial NCT04247854: Probiotics Pilot Project
Official title: Probiotic Bacillus for Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) in Patients Undergoing Total Joint Arthroplasty: A Randomized, Prospective, Placebo-Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Staphylococcus Aureus
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 20
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study is designed to determine if ingestion of Bacillus probiotics can cause alteration in levels of S. aureus colonization in the nose and intestine in preoperative orthopedic patients undergoing elective primary TJA.


Eligibility criteria: Inclusion Criteria:

1. Adults (age \>18 years)
2. Undergoing elective primary knee or hip arthroplasty
3. Confirmed colonization of nares and/or rectum with S. aureus or MRSA on routine standard-of-care preadmission testing
4. Written informed consent

Exclusion Criteria:

1. Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment
2. Antibiotic use within 3 months prior to enrollment
3. Active clinical infection
4. Participation in other clinical trials
5. Presence of pregnancy or lactation

Primary outcomes:
measure: Persistent Staphylococcus aureus colonization
timeFrame: post-intervention: following 5 days of dietary supplementation
Secondary outcomes:
measure: Changes in microbiome composition
timeFrame: post-intervention: following 5 days of dietary supplementation
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02356354: Study of the Cutaneous Reinnervation After Burn
Official title: Study of the Cutaneous Reinnervation After Burn With the Aim of a Better Care of Neuropathic Pain and Pruritus After Healing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-burn Innervation
Keywords: molecular factors
cutaneous innervation
skin biopsy
post-burn scar
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this study is to understand why the regeneration of the cutaneous sensory nerve fibers is poor in post-burn scar.

The presence or the lack of several molecular factors known to regulate neuronal cell development will be evaluate and compared within biopsies from healthy skin and post-burn scar.


Eligibility criteria: Inclusion Criteria:

* Major patients
* At least one year back deep burn (2nd and 3rd degrees), and allowing the comparison between the post-burn scar dermatome and the healthy opposite dermatome
* Patients always followed in the service of Plastic surgery of the hospital of Brest
* Informed consent and paper of the patient after information of the objective of the study and the protocol
* Analog Visual scales for pain and/or pruritus (EVA): greater than or equal to 3
* Simple Verbal scales for the pain and/or the pruritus ( EVS): pain / pruritus moderated to intense
* Membership to the Social Security

Exclusion Criteria:

* Allergy to xylocaine
* Non-Caucasian patients
* Treatments having an effect on the pain and/or the pruritus
* Sun or UV exposure several days preceding or following the biopsies

Primary outcomes:
measure: Number of the differences of expression of genes coding for regulating proteins of the innervation
timeFrame: 6 months
Secondary outcomes:
measure: Validation of the difference of density of intra-epidermic nerve fibers
timeFrame: 6 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Laurent MISERY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06897254: Outcomes of Critically Ill Patients Undergoing RRT- a Registry Based Study.
Official title: Outcomes of Acute Kidney Injury Requiring Renal Replacement Therapy in a Tertiary Level Teaching Hospital in Nepal: a Registry Based Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Replacement Therapies
Outcome Assessment
Keywords: renal replacement therapy
hemodialysis
intensive care unit
outcomes
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the ICU requiring renal replacement therapy

Brief summary: Rationale: Acute kidney injury (AKI) requiring renal replacement therapy (RRT) is a frequently occurring entity among critically ill patients. This study aims to determine the outcomes of patients undergoing renal replacement therapy in the ICU.

Study Objective: To find the outcomes of patients undergoing RRT in the ICU in terms of mortality and length of ICU stay.

Design: A registry based, retrospective, descriptive study. Sample size: Convenience sampling of all the patients who require RRT during the ICU stay.

Duration: Retrospective data from three years January 1, 2020 to December 30, 2023.

Place: Intensive care units (ICUs) of the Department of Critical Care Medicine, Tribhuvan University Teaching Hospital (TUTH).

Interventions: Not applicable Expected results: The study will help determine the outcomes of the critically ill patients undergoing RRT in a low middle income country ICU.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Admission to the ICU
* All patients undergoing RRT during ICU stay

Exclusion Criteria:

* None

Primary outcomes:
measure: ICU mortality
timeFrame: A the end of 3 years
Secondary outcomes:
measure: Treatment limitations
timeFrame: At the end of 3 years
Other outcomes:
measure: LOS-ICU
timeFrame: At the end of 3 years
Locations:
city: Maharajganj
country: Nepal
facility: Tribhuvan University Teaching Hospital
state: Bagmati
Study officials:
References:
citation: Cerda J, Mohan S, Garcia-Garcia G, Jha V, Samavedam S, Gowrishankar S, Bagga A, Chakravarthi R, Mehta R. Acute Kidney Injury Recognition in Low- and Middle-Income Countries. Kidney Int Rep. 2017 Jul;2(4):530-543. doi: 10.1016/j.ekir.2017.04.009. Epub 2017 Apr 25.
citation: Andonovic M, Traynor JP, Shaw M, Sim MAB, Mark PB, Puxty KA. Short- and long-term outcomes of intensive care patients with acute kidney disease. EClinicalMedicine. 2022 Feb 12;44:101291. doi: 10.1016/j.eclinm.2022.101291. eCollection 2022 Feb.
Clinical trial NCT05439954: Radiomics of Autism Spectrum Disorder
Official title: Application of MRI Radiomics to Improve Diagnosis and Pharmacologica Prognosis of Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Autism Spectrum Disorder
Keywords: MRI
radiomics
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 230
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: （a）patients fulfilling the Diagnostic Criteria of the Diagnostic and Statistical Manual of Mental Disorders 5th Edition（DSM-V); (b)age:14 and under 14 years old; (c)first clinic visit, never-treated; (d)without injury to head and other diseases of the nervous system.

Brief summary: Autism Spectrum Disorder (ASD) refers to a group of neurodevelopmental disorders including autism.Despite ongoing studies, the pathogenesis of ASD still remains unclear.The global prevalence of ASD was estimated at 1% in 2015.The diagnostic criteria for ASD are specified in the DSM ( American Psychiatric Association, 2013 ) and serve as guideline for clinicians at the present. However, its early diagnosis value is limited due to a high subjectivities and its low diagnostic sensitivity and specificity.Early detection and early pharmacological and behavioral interventions are critical in improving the symptoms and preventing the disease progression. There are no medications that directly treat the core symptoms present in individuals with ASD, and the effectiveness of interventions remains limited. Therefore, accurate assessment of pharmacological efficacy is necessary for the reatment, and prognostication of individuals with ASD. Magnetic resonance imaging (MRI) is a commonly used imaging tool for clinical disease diagnosis, especially for neurological disorders. Besides, Structural Magnetic Resonance imaging reflects neuropathological and microstructural developmental changes during growth. Radiomics based on the high-dimensional quantitation of medical images, allowing extraction of more detailed characteristics than is possible with conventional visual interpretation. This study aims: (1)To explore an objective diagnostic method through radiomics in children with ASD (2)to provide prognostic estimates of the outcome, based on estimates of an individual patient's prognosis and the efficacy of different drug therapies.


Eligibility criteria: Inclusion Criteria:（a）healthy subject of same ages;(b)without injury to head and diseases of the nervous system; (c)without family history of mental disorders; (d)without other somatic illness.

Exclusion Criteria:

-

Primary outcomes:
measure: diagnosis of autism spectrum disorder
timeFrame: 01/12/2022
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital at Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02017054: Feasibility and Outcomes of Repetitive Radial Approach
Official title: Feasibility and Outcomes of Repetitive Radial Approach
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Injury of Radial Artery
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with previous history of trans radial cardiac cath who are planned for additional trans radial cardiac cath

Brief summary: The purpose of this study is to assess the feasibility of performing repetitive coronary angiograms via the radial approach

Detailed description: Assessing succes of radial access in patients with prior TRA procedures

Eligibility criteria: Inclusion Criteria:

Patients with previous successful radial artery approach scheduled for elective transradial coronary angiography

Exclusion Criteria:

Lack of indication to perform radial approach Abnormal Barbeau test result (type C and D) Presence of radial artery occlusion Previous important trauma of the upper limbs Presence of fistula for renal dialysis Lymphoedema Acute myocardial infarction Refusal to sign the informed consent form

Primary outcomes:
measure: To assess patency of radial artery after repetitive radial artery access
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba MC
name: Amit Segev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03941054: Myosfascial Trigger-Points and Effects on Neuromuscular Response
Official title: Treatment of Myosfascial Trigger-Points of Gastrocnemius and Its Effects on the Neuromuscular Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Trigger Point Pain
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to analyze the effects of the treatment of the Myosfascial Trigger-Points detected in the gastrocnemius muscles on the neuromuscular response.


Eligibility criteria: Inclusion Criteria:

* Subjets with both active or latent Myosfascial Trigger Points

Exclusion Criteria:

* Pregnant women
* Musculoskeletal problems in the last month
* Surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months
* Psychological or nervous alterations
* Uncomprehension of the study protocol

Primary outcomes:
measure: change of neuromuscular stiffness of the gastrocnemious muscles
timeFrame: 10 minutes before the intervention, and 1 minute after the intervention
measure: change of elasticity of the gastrocnemious muscles
timeFrame: 10 minutes before the intervention, and 1 minute after the intervention
measure: change of relaxation of the gastrocnemious muscles
timeFrame: 10 minutes before the intervention, and 1 minute after the intervention
Secondary outcomes:
measure: change of active dorsiflexion ROM
timeFrame: 4 minutes before the intervention, and 6 minute after the intervention
measure: change of pasive dorsiflexion ROM
timeFrame: 2 minutes before the intervention, and 8 minute after the intervention
measure: change of gastrocnemious strength
timeFrame: 5 minutes before the intervention, and 5 minute after the intervention
measure: change of pain intensity
timeFrame: 8 minutes before the intervention, and 2 minute after the intervention
measure: change of pressure-pain threshold
timeFrame: 7 minutes before the intervention, and 3 minute after the intervention
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
affiliation: Anatomy lecturer
name: Albert Pérez-Bellmunt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02799654: Excia T Cementless EBRA Study
Official title: Non-Interventional Post Market Clinical Follow-up Study Excia T® Cementless EBRA Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthritis, Degenerative
Arthritis, Rheumatoid
Hip Fractures
Femur Head Necrosis
Keywords: Total Hip Arthroplasty
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication for cementless primary Total Hip Arthroplasty

Brief summary: In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and radiological results of the cementless Excia T® prosthesis in routine clinical use shall be assessed and the migration taking place in the first 24 months evaluated.


Eligibility criteria: Inclusion Criteria:

* Written patient consent to study participation
* Age \> 18 years
* Indication for primary THA with cementless Excia T® stem

Exclusion Criteria:

* Pregnancy
* THA after fracture
* Rheumatoid arthritis
* Systemic disorders, treated with Cortisone or other pharmaceuticals, potentially compromising the bone quality
* Patient physically or mentally not able to follow the postoperative examination routine

Primary outcomes:
measure: Subsidence over time of Excia T® stem (EBRA-FCA)
timeFrame: discharge (approx. 1 week postop), 3, 12 and 24 months postoperative
Secondary outcomes:
measure: Clinical Results over time (Harris Hip Score)
timeFrame: preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative
measure: Quality of Life over time (EQ-5D-5L)
timeFrame: preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative
measure: Osteolysis over time (localized bone resorption)
timeFrame: 3, 12 and 24 months postoperative
measure: Radiolucent lines over time
timeFrame: 3, 12 and 24 months postoperative
measure: Cortical thinning
timeFrame: 3, 12 and 24 months postoperative
measure: Hypertrophy
timeFrame: 3, 12 and 24 months postoperative
measure: Mechanical Alignment over time
timeFrame: discharge (approx. 1 week postop), 3, 12 and 24 months postoperative
measure: Adverse Events / Serious Adverse Events
timeFrame: until 24 months postoperative
Other outcomes:
Locations:
city: Celle
country: Germany
facility: Prof. Dr. med. E. Mayr
Study officials:
References:
Clinical trial NCT02889354: Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type
Official title: Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-09-05
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: The newly developed CBT for ADHD inattentive-type (ADHD-I) protocol is tested for feasibility and acceptability in a pilot study with a single group design. The study also evaluates measurements and recruiting possibilities, and effects of the intervention. Research hypotheses include: 1. There is a basis for recruiting ADHD-I patients for participation in an RCT at psychiatric outpatient units, 2. The measurements in the study are feasible and reasonable in regards to patient characteristics; that is, the patients are responding to the questionnaires as intended, 3. The CBT for ADHD-I intervention is feasible in terms of treatment completion, compliance to home assignments, and credibility and relevance, and is lacking of or involves a tolerable degree of adverse effects, and 4. The CBT for ADHD-I protocol reduces core symptoms of ADHD-I as well as symptoms of stress, depression, and anxiety, and improves quality of life.


Eligibility criteria: Inclusion Criteria:

In addition to an ADHD inattentive-type diagnosis, inclusion criteria are:

1. 18 years or older,
2. intelligence quotient above 80-85, and
3. if on medication, it needs to be well-established since three months.

Exclusion Criteria:

1. autism spectrum disorder,
2. ongoing substance use disorder,
3. difficulties in compliance with medical or other treatment,
4. social and/or psychiatric problems to such an extent that it prevents focusing on treatment, or
5. ongoing cognitive-behavioral therapy.

Primary outcomes:
measure: Brown ADD Scales
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Capio Psykiatri AB
Study officials:
affiliation: Karolinska Institutet
name: Benjamin Bohman, PhD
role: PRINCIPAL_INVESTIGATOR
References: