louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05738668: Clinical-immunological Features of Anti-NMDAR Encephalitis
Official title: Clinical-immunological Features of Anti-NMDAR Encephalitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anti NMDA Receptor Encephalitis
Keywords: Anti NMDA Receptor Encephalitis
antibodies
relapses
outcomes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 400
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with well-characterized anti-NMDAR encephalitis

Brief summary: Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers


Eligibility criteria: Inclusion Criteria:

* Patient with neurological disorder
* Patient with NMDAR antibodies in sera or CSF

Exclusion Criteria:

* - No available clinical data
* Patient without NMDAR antibodies or neurological disorder

Primary outcomes:
measure: Modified Rankin scale (mRS)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est
state: Bron
Study officials:
References:
Clinical trial NCT02435368: The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and LPS on IL-1β Secretion by Mononuclear
Official title: The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and Lipopolysaccharide on Interleukin-1β Secretion by Mononuclear
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lupus Nephritis
Lead sponsor: The Third Affiliated Hospital of Southern Medical University
Sponsor class: OTHER_GOV
First posted: 2015-05-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers,age 18-60.

Brief summary: To determine the mechanisms and significances of synergistic effects of mycophenolic acid and LPS on IL-1β secretion by mononuclear

Detailed description: Mycophenolate mofetil (MMF), which inhibits T and B lymphocyte proliferation, is widely used to treat a variety of autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN). We are the first to show that mycophenolic acid (MPA), the active metabolite of MMF, in association with lipopolysaccharide (LPS), is able to promote the secretion of interleukin (IL)-1β, which contradicts the traditional conception that immunosuppressants inhibit the secretion of inflammatory factors.

In this study, we first determined the effects of MPA in association with LPS on IL-1β production. Then, we explored whether the synergized effect on IL-1β production was mediated through the nuclear factor （NF）-κB pathway that produces more pro-IL-1β, or through the triggering of NLRP3 inflammasome that leads to enhanced activation of caspase-1 and accelerated degradation of pro-IL-1β into mature IL-1β.

This study is not only conducive to clarify the mechanisms, signal transduction pathways and potential clinical significances of IL-1β production in LPS and MPA combined treatment, but also to provide experimental data as well as theoretical rationales for more effective and more logical immunosuppressive protocols.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers，age 18-60.

Exclusion Criteria:

* Don't agree with informed consent

Primary outcomes:
measure: mean ± SD of percentage of IL-1β production induced by Lipopolysaccharide in associate with MPA in monocytes.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital of Southern Medical University
name: erwei Sun, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06176768: A Study of LY3972406 in Adult Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3972406 in Adults With Moderate-to-Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-12-20
Enrollment: 75
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: The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Have moderate-to-severe chronic plaque psoriasis for at least 6 months prior to baseline
* Have venous access sufficient to allow for blood sampling
* Are able to swallow oral medication

Exclusion Criteria:

* Have any other skin conditions, excluding plaque psoriasis
* Have a current or recent acute, active infection
* Have manifestations of other autoimmune diseases, such as systemic lupus erythematosus.
* Are lactating or breastfeeding women

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 75)
timeFrame: Week 12
Secondary outcomes:
measure: Mean Change from Baseline in Body Surface Area (BSA)
timeFrame: Baseline, Week 12
measure: Mean Change from Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, Week 12
measure: Pharmacokinetics (PK): Plasma Concentration of LY3972406
timeFrame: Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Coral Gables
country: United States
facility: Driven Research
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Hackensack
country: United States
facility: Schweiger Dermatology Group
state: New Jersey
city: Kenilworth
country: United States
facility: Metropolitan Dermatology - Clark
state: New Jersey
city: Winston-Salem
country: United States
facility: Accellacare - Winston-Salem
state: North Carolina
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Camp Hill
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 on - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005668: A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
Official title: A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aspergillosis
Lung Diseases, Fungal
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma.

Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.

Detailed description: Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.

Eligibility criteria: Inclusion Criteria:

You may be eligible for this study if you:

* Are 18 years of age or older.
* Have been diagnosed with aspergilloma within the last month.
* Have (or have a history of) at least one of the following:

  1. positive test for Aspergillus species.
  2. presence of antibodies to Aspergillus.
* Are willing to participate in the study for 2 full years.
* Are female and not pregnant.
* Are not breast-feeding.
* Agree to use barrier methods of birth control / contraception during the study and for 30 days after.

Exclusion Criteria:

You will not be eligible for this study if you:

* Have a history of allergy to triazole or imidazole drugs.
* Are unable to take oral medication.
* Are not expected to live for more than a month.
* Have had a lung biopsy indicating Aspergillus infection.
* Have had radiation therapy within the last 6 months.
* Require treatment with certain medications.
* Received amphotericin, amphotericin lipid formulation, fluconazole, or itraconazole in the two weeks prior to study entry.
* Received chemotherapy within the last 6 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Mary Ellen Bradley
state: Alabama
Study officials:
References:
Clinical trial NCT01270568: Mind-body Interventions in Cardiac Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Congestive Heart Failure
Keywords: positive psychology
cardiovascular disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-01-05
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: This study is investigating whether a series of psychological exercises, called positive psychology, provides benefit to patients who have been hospitalized for heart disease (an 'acute coronary syndrome' or heart failure).

In this study, subjects are randomly assigned to complete 8 positive psychology exercises over 8 weeks, or to complete different exercises in control groups.

We hypothesize that patients who are assigned to the positive psychology tasks will be able to complete the exercises at a high rate, will feel that the exercises were easy to perform, and will have greater improvements of optimism, anxiety, mood, and health-related quality of life than subjects in the control conditions.


Eligibility criteria: Inclusion Criteria:

* Hospitalization at Massachusetts General Hospital for an acute coronary syndrome or congestive heart failure
* Able to read/write in English
* Have working home or cellular phone

Exclusion Criteria:

* Cognitive disorder
* Medical condition likely to lead to death within 6 months
* Illness leading to inabilty to consent or complete study exercises
* Current or prior participation in positive psychology interventions

Primary outcomes:
measure: Feasiblity
timeFrame: 8 weeks
Secondary outcomes:
measure: Optimism
timeFrame: 8 weeks
measure: Happiness
timeFrame: 8 week
measure: Depression
timeFrame: 8 weeks
measure: Anxiety
timeFrame: 8 weeks
measure: Mental-health related quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00131768: A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: osteoarthritis of the ankle
musculoskeletal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-08-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic ankle osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the initial 3 months follow up period.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic OA pain of ankle (talo-crural)

Exclusion Criteria:

* Patients with current or prior conditions or treatments that would impede measurements of efficacy or safety

Primary outcomes:
measure: Pain relief
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie
city: Neuss
country: Germany
facility: Johanna Etienne Krankenhaus
city: Bologna
country: Italy
facility: Instituti Ortopedici Rizzoli
city: Pisa
country: Italy
facility: Ospedale Santa Chiara, Clinica Ortopedica, Universita di Pisa
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01758068: Effect of Twice Daily Application of Coconut Oil in Reducing Water Loss From Skin of Premature Babies in First Week of Life
Official title: Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trans Epidermal Water Loss
Keywords: Preterms
Coconut Oil application
Trans epidermal water loss
Weight gain
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
Collaborators: name: All India Institute of Medical Sciences
First posted: 2012-12-31
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight as water loss from their skin during the first week of life. Many strategies have been utilized by neonatologists to decrease this water loss. Edible coconut oil application on the skin acts as a non permeable barrier and can help in achieving this. Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application.


Eligibility criteria: Inclusion Criteria:

All preterm babies born at the study center with birth weight \< 1500g were eligible for inclusion in the study.

Exclusion Criteria:

1. Babies with birth weight less than 750 gms at birth
2. Babies with major congenital malformations.
3. Babies with severe asphyxia, hydrops and shock.
4. Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
5. Babies with preexisting skin infection such as multiple furuncles (2 or more skin areas - each limb, head, chest, abdomen and back are the individual areas that will be taken as one area)

Primary outcomes:
measure: Trans Epidermal Water Loss(TEWL)
timeFrame: first 7 days of life
Secondary outcomes:
measure: Weight
timeFrame: first 7 days of life and 40 weeks postmenstrual age
measure: Skin condition Score
timeFrame: at day 7 of life
measure: Skin colonization pattern
timeFrame: at day 7 of life
Other outcomes:
Locations:
Study officials:
affiliation: All India Institute of Medical Sciences
name: Sushma Nangia, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nangia S, Paul VK, Deorari AK, Sreenivas V, Agarwal R, Chawla D. Topical Oil Application and Trans-Epidermal Water Loss in Preterm Very Low Birth Weight Infants-A Randomized Trial. J Trop Pediatr. 2015 Dec;61(6):414-20. doi: 10.1093/tropej/fmv049. Epub 2015 Sep 3.
Clinical trial NCT03162172: Growth Hormone (GH) in Congenital Adrenal Hyperplasia
Official title: Evaluation of the Adult Height Gain With Growth Hormone Treatment in Children With Congenital Adrenal Hyperplasia (CDAH), Using the OPALE Prediction Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Hyperplasia, Congenital
Keywords: congenital adrenal hyperplasia
short stature
growth hormone treatment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with genetically proven CAH, classical form, or simple virilizing, with 21 hydroxylase, or 11ᵝ hydroxylase, or 3βol-dehydrogenase deficit, born between 1970 and 1998, having received GH treatment for a minimal one year duration.

Brief summary: Congenital adrenal hyperplasia (CAH) is a genetic rare disease, which alters the adrenal production of gluco and mineralo corticoids. The treatment consists in supplementing children using hydrocortisone. Despite care for these children has improve substantially across decades, short adult height still remains an important consequence of the disease. About 20 % of patients have an AH below 2 standard deviations compared to their expected height.

In the OPALE model study, the investigators have collected data from a cohort of 496 French patients, born between 1970 and 1991 and with a known genotype. Using their age, sex, growth, disease, bone maturation and pubertal data, they have built a model which allows to predict their AH using data available at 8 years of age. This model has shown that the currently used formula to calculate the predicted AH (Bayley Pineau's method) is not applicable to children with CAH.

In this project, the investigators plan to use the prediction model to compare the AH in patients who have received GH treatment to their predicted AH using the model.

The hypothesis is that GH improves the AH in such patients. Existing cohorts have shown improved growth celerity, and growth expectation using the Bayley-Pineau formula), but this has not been shown on the actual AH.

This study will allow to reinforce the investigators' hypothesis.


Eligibility criteria: Inclusion Criteria:

Patients with CAH, born between 1970 and 1998, having received GH treatment for a minimal one year duration.

Exclusion Criteria:

* Patients with chronic any growth altering disease, Turner syndrome or other genetic anomaly; 8-year wrist Xray and adult height should be available to allow the use of the OPALE model prediction.

Primary outcomes:
measure: Adult height (AH) gain
timeFrame: up to 18 years
Secondary outcomes:
measure: Number of treatment withdrawal due to adverse events
timeFrame: up to 6 years of GH treatment
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Patricia Bretones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04167072: Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy
Official title: Scheduled Stent Removal vs Observation in Patients Undergoing EUS-guided Gallbladder Drainage. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cholecystitis, Acute
Cholecystitis; Gallstone
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the outcomes of patients with gallstone related cholecystitis who are poor surgical candidates undergoing EUS guided cholecystoenterostomy via a lumen apposing metal stent (LAMS).

Detailed description: The study will include patients with stone related cholecystitis that are not adequate surgical candidates that will be treated with EUS guided cholecystoenterostomy with endoscopic stone extraction. Patients will be randomized to stent removal immediately after gallstones have been removed or to observation for 1 year with the stent in place. Outcomes to be measured include recurrence of stone disease and rate of complications from the procedure in both groups

Eligibility criteria: Inclusion Criteria:

1. Ages 18-100 years or age
2. Both genders
3. Diagnosis of acute cholecystitis by TG13 criteria.
4. Patients who are able to give consent
5. Patients who are deemed poor surgical candidates for cholecystectomy by the surgical/medical team.

Exclusion Criteria:

1. Unable to provide informed consent
2. Cardiorespiratory dysfunction that precludes sedation
3. Pregnant females
4. Presence of ascites (distance between duodenum and GB \> 1 cm) and/or coagulopathy (INR \> 3, PLT \<20K)

Primary outcomes:
measure: Recurrence of GB findings
timeFrame: 1 year
Secondary outcomes:
measure: Rate of adverse events related to LAMS
timeFrame: 1 year
Other outcomes:
Locations:
city: El Paso
country: United States
facility: University Medical Center of El Paso
state: Texas
Study officials:
References: