louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00919776: Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Official title: A Pilot Double Blind Controlled Study Randomizing Patients Whose ENL is Not Controlled With Standard Prednisolone, and Comparing a Group Treated With Ciclosporin to a Group Treated With Additional Steroid Only.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leprosy
Keywords: Leprosy
ENL
Erythema Nodosum Leprosum
Prednisolone
Ciclosporin
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Homes and Hospitals of St Giles
name: Alert Hospital, Ethiopia
name: Armauer Hansen Research Institute, Ethiopia
First posted: 2009-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone.

Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.

Detailed description: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.

Eligibility criteria: Inclusion Criteria:

* Individuals with clinical evidence of recurrent or chronic ENL
* Aged 18-65
* Weigh more than 30Kg

Exclusion Criteria:

* Unwillingness to give informed consent
* Patients with severe active infections such as tuberculosis
* Pregnant or breastfeeding women (see Appendix II)
* Those with renal failure, abnormal renal function, hypertensive
* Patients taking thalidomide currently or within the last 3 months
* Patients not willing to return for follow-up
* Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
* HIV positive patients

Primary outcomes:
measure: number of ENL recurrence episodes per patient
timeFrame: up to 32 weeks
Secondary outcomes:
measure: Mean time to ENL recurrence after initial control
timeFrame: up to 32 weeks
measure: Severity of ENL at recurrence
timeFrame: up to 32 weeks
measure: Amount of additional prednisolone required by patients
timeFrame: up to 32 weeks
measure: Frequency of adverse events for patients in each treatment arm
timeFrame: up to 32 weeks
measure: Difference in score in Quality of Life assessment between start and end for patients in each treatment arm
timeFrame: up to 32 weeks
Other outcomes:
Locations:
city: Addis Abeba
country: Ethiopia
facility: Alert Hospital
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Diana NJ Lockwood, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02595476: Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus
Official title: The Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus Under Steady-state Remifentanil Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: analgesia
pupillometry
general anesthesia
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.


Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* scheduled for an idiopathic scoliosis surgical correction

Exclusion Criteria:

* Ophtalmologic pathology
* Neurologic or muscular pathology
* Metabolic pathology
* Chronic pain

Primary outcomes:
measure: Post-stimulation Pupillary reflex dilation
timeFrame: 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
affiliation: Hopital Armand Trousseau
name: Isabelle Constant, MD, PHD
role: STUDY_DIRECTOR
References:
citation: Sabourdin N, Peretout JB, Khalil E, Guye ML, Louvet N, Constant I. Influence of Depth of Hypnosis on Pupillary Reactivity to a Standardized Tetanic Stimulus in Patients Under Propofol-Remifentanil Target-Controlled Infusion: A Crossover Randomized Pilot Study. Anesth Analg. 2018 Jan;126(1):70-77. doi: 10.1213/ANE.0000000000001802.
Clinical trial NCT01931527: Effect of Reducing Uric Acid on Insulin Sensitivity and Oxidative Status
Official title: Effect of Plasma Uric Acid on Insulin Sensitivity, Endothelial Function and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Hyperuricemia
Keywords: Obesity
Metabolic syndrome
Hyperuricemia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn more about what is the effect of uric acid on oxidative stress and on the way the body metabolizes sugar in obese people. Understanding this may lead to better diseases such as diabetes.

Detailed description: It has been hypothesized that oxidative stress is involved in the pathogenesis of insulin resistance associated with obesity. Circulating uric acid (UA) is the body's major endogenous plasma antioxidant. Therefore, the investigators evaluated whether alterations in serum UA concentration affect: 1) systemic and skeletal muscle oxidative stress, 2) total antioxidant capacity, and 4) skeletal muscle insulin sensitivity during a hyperinsulinemic-euglycemic clamp.

Eligibility criteria: Inclusion Criteria:

* obese (BMI 30-45 kg/m²);
* serum UA concentration either ≥5 mg/dL or ≤4.0 mg/dL (297 µmol/L)\],

Exclusion Criteria:

* renal dysfunction (serum creatinine \>1.5 mg/dL);
* pregnancy or lactating;
* take urate-lowering agents, thiazide diuretics, prednisone or medications containing aspirin or other salicylates;
* history of xanthinuria, type 2 diabetes or other significant organ system dysfunction;
* have G6PD deficiency;
* use hormone-replacement or oral-contraceptive therapy;
* smoke tobacco;
* anemic (Hb \<10 g/dl)

Primary outcomes:
measure: Percent Increase in Insulin-stimulated Glucose Uptake
timeFrame: 12 hours after reducing uric acid
Secondary outcomes:
measure: The Effect of Reducing Uric Acid on Oxidative Status
timeFrame: 12 hours after reducing uric acid
measure: Baseline Carbonylated Protein Ratio
timeFrame: Before reducing uric acid
measure: AFTER Rasburicase Carbonylated Protein Ratio
timeFrame: 12 hours after reducing uric acid
measure: Baseline Plasma TRAP
timeFrame: Before reducing uric acid
measure: AFTER Rasburicase Plasma TRAP
timeFrame: 12 hours after reducing uric acid
measure: Baseline Plasma FRAP
timeFrame: Before reducing uric acid
measure: AFTER Rasburicase Plasma FRAP (Fe⁺² · Lˉ¹)
timeFrame: 12 hours after reducing uric acid
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00506727: Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD
Official title: A Randomized, Double-Blind, Parallel-Group, Analog Classroom Study, Evaluating ADDERALL XR Versus STRATTERA, Dosed Once Daily, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ADHD
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 215
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of ADHD combined subtype or predominantly hyperactive-impulsive subtype, based on psychiatric evaluation
* Capable of understanding and following classroom instructions
* Generally functioning academically at age-appropriate levels

Exclusion Criteria:

* ADHD, predominantly inattentive subtype
* Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD, severe depressive or severe anxiety disorder
* Documented history of aggressive behavior serious enough to preclude participation in regular classroom activities
* Documented allergies or intolerance to either of the active treatments or tricyclic antidepressants

Primary outcomes:
measure: Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21)
timeFrame: Approximately 3 weeks
Secondary outcomes:
measure: PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL
timeFrame: Approximately 3 weeks
measure: treatment-emergent adverse events
timeFrame: approximately 3 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Wigal SB, McGough JJ, McCracken JT, Biederman J, Spencer TJ, Posner KL, Wigal TL, Kollins SH, Clark TM, Mays DA, Zhang Y, Tulloch SJ. A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorder. J Atten Disord. 2005 Aug;9(1):275-89. doi: 10.1177/1087054705281121.
Clinical trial NCT00904527: Interest of Relaxation From Patients With Pain Due to Migraine
Official title: Interest of Relaxation From Patients With Pain Due to Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Relaxation (Schultz)
Migraine
antipain center
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.

Detailed description: This randomized, multicenter study compares 2 parallel groups of patients with migraine :

* I: patients are treated with relaxation + medical treatment (beta-bloquant or Oxetorone)+ patients' education
* II: patients are treated only with medical treatment + patients' education.

Visit 1 : 1 month before randomization for patient's selection and baseline data

Visit 2 (J0): inclusion (randomization) During the first 2 months patients from group I benefit from relaxation consultations.

Visit 3 (2 months after randomization)and visit 4 (4 months after randomization) : evaluation of the efficacy of the two treatment strategies.

Primary endpoint :

- number of days with migraine per month from J0 to visit 4.

Secondary endpoints :

* monthly drug consumption
* percentage of patients who respond (50 % frequency reduction)
* quality of life (SF 36)

Each day, patients note in a notebook if a migraine appears and its intensity.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* 5 to 14 days of migraines per month

Exclusion Criteria:

* Headache by medication abuse
* Patients who already know relaxation technics
* Depression
* Contra indication of using beta-bloquant or Oxetorone

Primary outcomes:
measure: Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)
timeFrame: 4 months
Secondary outcomes:
measure: Comparison between the 2 groups of intensity of migraine, medication use and quality of life
timeFrame: 4 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Consultation de la douleur du CHU d'Amiens
city: Bordeaux
country: France
facility: UTCD - CHU Pellegrin
city: Caen
country: France
facility: CETD - CHU de Caen
city: Clermont-Ferrand
country: France
facility: CETD du CHU Gabriel Montpied
city: Grenoble
country: France
facility: CETD CHU de Grenoble
city: Le Puy-en Velay
country: France
facility: Consultation de la douleur - CH Emile Roux
city: Nemours
country: France
facility: CETD CH de Nemours
city: Saint Etienne
country: France
facility: CETD du CHU de Saint-ETienne
city: Toulouse
country: France
facility: CETD Hôpital Rangueil
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: LAURENT Bernard, MD PhD
role: STUDY_DIRECTOR
affiliation: Centre d'Investigation Clinique de Clermont-Ferrand
name: PICKERING Gisèle, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06423027: Nature-Oriented Chatbots on Older Adults' Mental Health
Official title: Exploring the Influence of Nature-Oriented Chatbots on the Mental Health of Older Adults Living Alone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Loneliness
Happiness
Connection With Nature
Anxiety
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to explore the influence of nature-oriented chatbots on the mental health of older adults residing alone. Leveraging the therapeutic potential of nature exposure and the interactive capabilities of chatbot technology, our research seeks to investigate whether engaging with nature-oriented chatbots can mitigate feelings of depression, and loneliness while enhancing overall psychological well-being and quality of life. Through a combination of experimental interventions and psychological assessments, the investigators will assess the impact of nature-oriented chatbots on participants' mental health outcomes.


Eligibility criteria: Inclusion Criteria:

1. Individuals aged 60 years and above who live alone.
2. Regular users of smartphones, with internet access, and proficient in using LINE.
3. Individuals who consent to participate in the study and sign the consent form.
4. Capable of understanding interactive messages and the content of pre- and post-test questionnaires.

Exclusion Criteria:

1. Individuals without smartphones, internet access, or not using LINE.
2. Diagnosed with sensory impairments.
3. Diagnosed with mental illnesses requiring continuous treatment.

Primary outcomes:
measure: Depression
timeFrame: up to 8 weeks
measure: loneliness
timeFrame: up to 8 weeks
measure: happiness
timeFrame: up to 8 weeks
measure: connection with nature
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01841827: The Headache Inducing Effects of Cilostazol on Migraine Patients
Official title: The Headache Inducing Effects of Cilostazol on Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We will use Cilostazol as a tool to investigate its headache inducing effects in migraine patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with migraine without aura according to the IHS criteria from 2004.
* Healthy besides migraine

Exclusion Criteria:

* Tension-type headache more than 3 days per month
* Other types of primary headaches
* Pregnancy
* History of vascular diseases or psychiatric diseases.

Primary outcomes:
measure: The incidens of headache or migraine after adminstration of Cilostazol in migraine patients compared to placebo.
timeFrame: Outcome measure will be done within 3 month. Final data will be presented within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center & Department of Neurology
state: Glostrup
Study officials:
References:
Clinical trial NCT06532227: AspergillusOne-Health: Deciphering Azole Resistance in Aspergillus Fungi Using a One Health Approach
Official title: AspergillusOne-Health: Deciphering Azole Resistance in Aspergillus Fungi Using a One Health Approach
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aspergillus Fumigatus Infection
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective inclusion of patients sampled as part of their care in a pneumology department (Nantes University Hospital or CHD Vendée) who are carriers of aspergillus. Patients will be contacted by email or paper mail if a strain is isolated.

Only patients with resistant strains and susceptible patients matched to resistant strains for this study will also receive a home visit from the CMEI (except for patients living in institutions).

Brief summary: During a two year prospective study onpatients from department's hospitals and centralized by the pneumology department Nantes CH,all respiratory clinical samples will be cultivated for Aspergillus isolation (2900Aspergillusisolates) as standard care. The azole susceptibility pattern of isolates will be determined to itraconazole, voriconazole by subculture on azole- enriched medium at 35°c as primary screen and resistance confirmed by EUCAST Reference metho.In parallel, the relevance of detecting resistance (TR34 and TR46) directly in culture-negative BAL respiratory samples by a qPCR method will be studied in an attempt to reach a greater exhaustiveness of the resistance phenomeno. In case of azole-resistant isolate,patient data such as the underlying disease,date and site of Aspergillus isolation,disease classification,previous azole drug exposure,and home and work geographic allocation,occupation of the patient will be collecte. For all other aspergillus occurrences, underlying disease, previous azole drug exposure,home and work location of the patient will be collected in an attempt to identify risk factor.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Patient who has given his or her consent to participate in the study
* Patient affiliated to a social security scheme
* Patient with a respiratory sample taken between 2020 and 2023 for the retrospective cohort and from 2024 for the prospective cohort in which Aspergillus has been isolated
* Patients living in the Loire Atlantique and Vendée regions

Exclusion Criteria:

* Patient under guardianship or legal protection
* Patient of no fixed adress

Primary outcomes:
measure: Environmental risk factors
timeFrame: 24 months
Secondary outcomes:
measure: Describe the management and evolution of resistant
timeFrame: 48 months
measure: Risk factors
timeFrame: 48 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06715527: Treatment of Women With Hyperandrogenic PCOS With Two Different Ratios of Myo-inositol:D-chiro-inositol: A Comparison
Official title: Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovarian Syndrome (PCOS)
Keywords: PCOS
myo-inositol
D-chiro-inositol
menstual cycle
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study.

Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated.

In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.


Eligibility criteria: Inclusion Criteria:

* PCOS according to the Rotterdam Criteria
* Clinical or biochemical hyperandrogenism

Exclusion Criteria:

* other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism)
* other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome)
* use of medications that influence ovulation
* hormonal treatments
* chronic pharmacological therapies
* use of inositol-containing supplements
* regular consumption of inositol-enriched food

Primary outcomes:
measure: Restoration of regular menstrual cycle
timeFrame: From enrollment (T0) to the completion of the study at 3 months (T3M)
Secondary outcomes:
measure: Hormonal status
timeFrame: From enrollment (T0) to the completion of the study at 3 months (T3M)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Alma Res Fertility Center
state: ITA
Study officials:
References: