louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00664599: Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease
Official title: Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Behcet's Syndrome
Keywords: Ocular lesions, Visual Acuity, Retinal Vasculitis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2008-04-23
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.

Detailed description: To test in a single blind randomized control study the efficacy of Rituximab versus combination of pulse cyclophosphamide and azathioprine. Both group receiving 0.5 mg/kg/daily prednisolone.

Eligibility criteria: Inclusion Criteria:

* Behcet's Disease fulfilling the new International Criteria for Behcet's Disease
* Having active ocular lesions (posterior and/or retinal vasculitis)
* Resistant to cytotoxic drugs + prednisolone 0.5 mg/kg

Exclusion Criteria:

* Visual acuity less than 1/10 on Snellen chart
* Antecedent of allergic reaction to any component of the therapeutic regimen

Primary outcomes:
measure: Visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: Inflammatory index for posterior uveitis
timeFrame: 6 months
measure: Inflammatory index for retinal vasculitis, especially for edema
timeFrame: 6 months
measure: Total Adjusted Disease Activity Index (TADAI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rheumatology Research Center, Shariati Hospital
Study officials:
affiliation: Rheumatology Research Center, Tehran University for Medical Sciences
name: Fereydoun Davatchi, MD
role: STUDY_CHAIR
affiliation: Rheumatology Research Center, Tehran University for Medical Sciences
name: Hormoz Shams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rheumatology Research Center, Tehran University for Medical Sciences
name: Mozhgan Rezaipoor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rheumatology Research Center, Tehran University for Medical Sciences
name: Farhad Shahram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rheumatology Research Center, Tehran University for Medical Sciences
name: Cheyda Chams-Davatchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rheumatology Research Center, Tehran University for Medical Sciences
name: Bahar Sadeghi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06470399: AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome
Official title: AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: AI-guided dietary supplementation
Metabolic parameters improvement
Genetic profiling
metabolic profiling
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study "AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome" aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing metabolic syndrome. This 6-month randomized controlled trial included 160 participants diagnosed with metabolic syndrome. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in metabolic parameters, while secondary outcomes included individual components of metabolic syndrome, inflammation levels, body weight, and adherence to the DS regimen. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.


Eligibility criteria: Inclusion Criteria:

* Age between 40 and 75 years.
* Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria:
* Waist circumference \> 102 cm (men) or \> 88 cm (women).
* Triglycerides ≥ 150 mg/dL.
* HDL cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women).
* Blood pressure ≥ 130/85 mm Hg.
* Fasting glucose ≥ 100 mg/dL. • Willingness to provide genetic and metabolic data.

Exclusion Criteria:

* Significant renal, hepatic, or cardiovascular diseases.
* Use of dietary supplements that affect metabolic parameters within the last 3 months.
* Pregnancy or breastfeeding.

Primary outcomes:
measure: Composite Metabolic Syndrome Score
timeFrame: 6 months
Secondary outcomes:
measure: Waist Circumference change in cm
timeFrame: 6 months
measure: Triglycerides change in mg/dl
timeFrame: 6 months
measure: HDL Cholesterol change in mg/dl
timeFrame: 6 months
measure: Blood Pressure change in mmHg
timeFrame: 6 months
measure: Fasting Glucose in mg/dl
timeFrame: 6 months
measure: High-Sensitivity C-Reactive Protein change
timeFrame: 6 months
measure: Body Weight change in kg
timeFrame: 6 months
measure: body mass index (BMI) change
timeFrame: 6 months
measure: Incidence of any Adverse Effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References:
Clinical trial NCT00949299: Effects of Buprenorphine on Ulnar Nerve Motor Block
Official title: Effects of Buprenorphine on Ulnar Nerve Motor Block
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Recent reports showed that the opioid buprenorphine is a very potent sodium channel blocker. Buprenorphine not only exerts a strong antinociception, but also a long lasting antihyperalgesic effect. This antihyperalgesic effect is not observed for other clinically employed opioids but is common for local anaesthetics.

The principal aim of the study is to compare the speed of onset and the time of recovery of motor blockage achieved by lidocaine and buprenorphine, respectively. The investigators hypothesize that the blocking capacity of buprenorphine is equal to the one of lidocaine.


Eligibility criteria: Inclusion Criteria:

1. Male
2. Age: 18 - 65 years
3. Weight: 50-100kg
4. Height: 155-195cm
5. Signed and dated informed consent
6. Sufficient command of German language

Exclusion Criteria:

1. Contraindications to the class of drugs under study
2. Vulnerable subjects (intellectually or mental impaired)
3. Known hypersensitivity to class of drugs or the investigational product
4. Drug abuse
5. Known peripheral neuropathies
6. Diabetes mellitus
7. Chronic alcohol consumption
8. Congestive heart disease
9. Participants of other studies during study period

Primary outcomes:
measure: The principal aim of the study is to measure the speed of onset and the time of recovery of motor blockage achieved by lidocaine and buprenorphine
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institut of Anaesthesiology
state: ZH
Study officials:
affiliation: Oberarzt Institute of Anesthesiology
name: Konrad Maurer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001999: A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
Official title: A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
Gamma-Globulins
Ganciclovir
Drug Therapy, Combination
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Immunization, Passive
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration of remission than DHPG alone (i.e. 16 weeks). To evaluate the toxicities of the combination of DHPG and immune globulin as compared to those of DHPG alone. To evaluate if there is a difference between the two groups in regard to survival, immune functions, and CMV viremia and viruria.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* First episode of sight-threatening CMV retinitis.
* At least one pending culture for CMV from the blood or urine prior to entry.
* Life expectancy \> 6 months.
* Karnofsky performance = or \> 60.
* Ability to understand the nature of the study, to comply with study requirements, and to sign informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* Known selective IGA deficiency or antibodies against IgA.
* History of previous episodes of sight-threatening CMV retinitis.

Patients with the following are excluded:

* Previous episode of sight-threatening CMV retinitis.
* Concomitant treatment with other investigational agents except ddI or ddC.
* Life expectancy \< 6 months.
* Continued alcohol or drug abuse.
* Known selective IgA deficiency and known to have antibodies against IgA.
* Karnofsky performance \<60.

Other investigational agents except ddI or ddC.

ddI ddC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
Study officials:
References:
Clinical trial NCT01191099: Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance
Official title: Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-08-30
Enrollment: 150
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy-proven adenocarcinoma of the prostate who are to be treated with radical prostatectomy at the Department of Urology, University Hospital of Zurich

Brief summary: A single-center cohort study to identify uni- and multivariate associations between marker gene expression and clinico-pathological parameters for the detection of robust and novel prognostic tools in prostate cancer

Detailed description: 1. To perform a large scale assessment of tissue hypoxia by pimonidazole and hypoxia marker gene expression in human prostate cancers
2. To characterize expression and hypoxia/HIF-responsiveness of myoglobin, cytoglobin, α-hemoglobin in prostate tumors and cell lines
3. To identify uni- and multivariate associations between marker gene expression and clinico-pathological parameters for the detection of robust and novel prognostic tools in prostate cancers

Eligibility criteria: Inclusion criteria:

* Patients with biopsy-proven adenocarcinoma of the prostate who are to be treated with radical prostatectomy at the Department of Urology, University Hospital of Zurich
* Written informed consent

Exclusion criteria:

* Metastatic prostate cancer
* Contraindications to the class of investigational product under study, e.g. known hypersensitivity or allergy to the investigational product
* Severe heart or lung disease
* Severe liver or kidney dysfunction
* Severe stridor
* Distant metastases
* Concurrent treatment for other malignant disease
* Prior hormonal therapy or radiotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of urology
name: Michael Müntener, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03550599: Adequacy of Pain Treatment in Radiotherapy
Official title: Adequacy of Pain Treatment in Radiotherapy: an Observational, Prospective, Multicenter Study (ARISE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Pain
Analgesic Drugs
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 2000
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: 2000 consecutive patients accessing to Radiotherapy Unit

Brief summary: Aim of the study is to evaluate adequacy of pain treatment in oncologic patients, accessing to Radiotherapy Unit

Detailed description: Prescription of analgesic drugs is a basic topic in cancer patients, but undertreatment is common. The aim of the study is to analyse pain control and adequacy of antalgic treatments in patients coming to Radiotherapy Unit for radiation treatment.

Eligibility criteria: Inclusion Criteria:

- patients accessing to Radiotherapy Unit for radiation treatment (both palliative or with radical intent) with diagnosis of primitive or metastatic cancer;

Exclusion Criteria:

- Concomitant diseases that can affect reliability of collected data

Primary outcomes:
measure: Evaluation of adequacy of pain treatment
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
state: BO
Study officials:
affiliation: Radiation Oncology Center, Departement of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05481099: Reducing Test Anxiety in High School Students
Official title: Efficacy of a Cognitive Behavioural-based Intervention in Reducing Test Anxiety in High School Students: a Pilot Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Test Anxiety
Lead sponsor: Agrupamento de Centros de Saúde de Dão Lafões
Sponsor class: OTHER
Collaborators: name: Casa de Saúde São Mateus - Hospital
First posted: 2022-08-01
Enrollment: 519
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: School-age test anxiety is an important risk factor for school performance. Notwithstanding, few studies seek to identify which strategies are effective in improving test anxiety. This study aimed to test whether a cognitive-behavioural intervention for high school students could significantly reduce test anxiety.

A two-arm, cluster-randomized controlled, unblinded, parallel, trial was conducted. Participants were students of the 10th year of the Alves Martins High School in Viseu, Portugal. Students were randomized at class level to receive a cognitive-behavioural-based intervention combined with mindfulness, psychoeducation, and relaxation techniques, or to a control group with no intervention. Participants' anxiety levels were measured using the Test Anxiety Questionnaire. The analysis of the effect of the intervention was carried out on an intention-to-treat basis at the class level, using multilevel mixed effects models and Bayesian modelling.


Eligibility criteria: Inclusion Criteria:

* 10th grade students; both students and parents provide written informed consent

Exclusion Criteria:

* cognitive inability to answer the questionnaire and/or to participate in the intervention

Primary outcomes:
measure: Test anxiety
timeFrame: 12 weeks
Secondary outcomes:
measure: Worry
timeFrame: 12 weeks
measure: Emotionality
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Viseu
country: Portugal
facility: Alves Martins High School
Study officials:
References:
Clinical trial NCT03664999: Serum Immunologic Markers Levels in During the Delivery
Official title: Dynamics of Serum Immunologic Markers Levels in During the Delivery and Possible Benefit for Obstetric Emergency Diagnostics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunologic Markers
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 57
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients indicated for caesarean section

Brief summary: This study aim to describe dynamics of immunologic markers C1 inhibitor, C3, C4 during the delivery in order to improve early diagnostics of obstetric emergencies, especially with immune etiology.

Detailed description: Our prospective observational study will explore the differences between dynamics of the complement components C1 inhibitor, C1 inhibitor activity, C3, C4 during the labour in a group of women with physiologic pregnancy and in a group with a risk of complications (pre-eclampsia, HELLP syndrome, placenta praevia, placental abruption, IUGR, previous post partum hypotony).

We will focus on women undergoing the Caesarean delivery. We will also measure D vitamin levels and ACE levels and search for some contexts.

Eligibility criteria: Inclusion Criteria:

* Pregnant women undergoing the Caesarean delivery
* Signed informed consent

Exclusion Criteria:

* Previous hepatitis or other hepatocyte damage

Primary outcomes:
measure: Change in levels of total C1 inhibitor
timeFrame: 30 minutes before and 30 minutes after delivery
measure: Change in levels of CRP levels
timeFrame: 30 minutes before and 30 minutes after delivery
measure: Change in levels of D vitamin levels
timeFrame: 30 minutes before and 30 minutes after delivery
measure: Change in levels of ACE levels
timeFrame: 30 minutes before and 30 minutes after delivery
measure: Change of C1 inhibitor activity
timeFrame: 30 minutes before and 30 minutes after delivery
measure: Change in levels of total C3
timeFrame: 30 minutes before and 30 minutes after delivery
measure: Change in levels of total C4
timeFrame: 30 minutes before and 30 minutes after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
References:
Clinical trial NCT04539899: Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion
Official title: Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion : REAVIST
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: SUPPORTIVE_CARE

Brief summary: Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.

Observational, prospective, randomized, open-label, monocentric study.


Eligibility criteria: Inclusion Criteria:

* Female adult
* Who has benefited from contraceptive counseling
* The choice of an IUD (hormonal or copper)
* Having signed a written informed consent.
* Affiliation to a social security scheme.

Exclusion Criteria:

* Pre-existing dizzying sensations
* Severe facial wounds
* History of epilepsy
* Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.

Primary outcomes:
measure: NRS during IUD insertion
timeFrame: 20 minutes
Secondary outcomes:
measure: Stress level difference with virtual reality
timeFrame: 20 minutes
measure: Satisfaction level difference with virtual reality
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References: