louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01627236: Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Acute Exacerbation of Chronic Hepatitis B
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 120
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: The investigators will investigate the clinicopathological features of chronic hepatitis B patients with severe exacerbation selected by uniform criteria, and treated with early introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The investigators also observe the immune index in the change before and after the treatment, in order to searching for some prognostic index.


Eligibility criteria: Inclusion Criteria:

* serum hepatitis B surface antigen(HBsAg) positive for at least 6 months;
* All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on;
* serum T-Bil of 85.5 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day; or PTA of less than 60%;
* serum ALT of 20 times or more the ULN.

Exclusion Criteria:

* superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
* other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
* ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
* decompensated liver cirrhosis;
* severe bacterial or fungal infections;
* a history of diabetes or cardiac disease or hypertension or nephrosis.

Primary outcomes:
measure: survival rate
timeFrame: eight weeks
measure: liver function
timeFrame: eight weeks
measure: HBV-DNA
timeFrame: eight weeks
measure: prothrombin activity
timeFrame: eight weeks
measure: Child-Pugh degree
timeFrame: eight weeks
measure: model for end-stage liver disease
timeFrame: eight weeks
Secondary outcomes:
measure: length of patient stay
timeFrame: eight weeks
measure: hospitalization costs
timeFrame: eight weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University
name: Zhi-liang Gao, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04732936: Feasibility Study of a Temporary Peripheral Nerve Stimulator
Official title: Feasibility Study of a Temporary Peripheral Nerve Stimulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Injury
Lead sponsor: Epineuron Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 25
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: TREATMENT

Brief summary: A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.


Eligibility criteria: Inclusion Criteria:

* Are between 18-65 years old
* Have a Sunderland II-V peripheral nerve injury of the upper extremity
* Are receiving surgery within 14 days of injury

Exclusion Criteria:

* Nerve plexus injuries (e.g. brachial plexus)
* Nerve gap requiring graft/conduit, or extreme joint flexion
* Polyneuropathies
* Cognitive impairment and non-English-speaking
* Uncontrolled diabetes
* Surgical intervention \> 14 days of injury
* Co-enrollment in another clinical trial
* Pregnant women

Primary outcomes:
measure: Patient Tolerance to Therapy Questionnaire
timeFrame: Immediately after procedure
measure: Static Two Point Discrimination
timeFrame: 6 months
measure: Semmes-Weinstein Monofilament Test
timeFrame: 6 months
measure: DASH Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Safety
timeFrame: 6 months
measure: Device Usability Questionnaire
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Christopher Coroneos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05888636: Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma
Official title: Transcriptomics and Epigenetics Analysis for Biomarkers Identification Involved in Drug-resistance Mechanisms of Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Campus Bio-Medico University
name: University of Rome Tor Vergata
name: Sant'Eugenio Hospital, Rome
First posted: 2023-06-05
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the study, samples from patients with MGUS, MM smouldering and syntomatic MM will be used

Brief summary: Multiple Myeloma (MM) is the more common hematological neoplastic disease second only to Hodgkin lymphoma. In MM patients, mutated genes are mainly KRAS (23%), NRAS (20%), FAM46C (11%), DIS3 (11%) e TP53 (8%). Epigenetics studies suggested that Changes in histone modifications and DNA methylation pattern, as well as non-coding RNAs (miRNAs) expression are involved in MM development. In particular, it has been shown that the aberrant expression of different miRNAs could discriminate healthy from ill patients. Unfortunately, the main critical issue for an effective treatment of MM is the intrinsic or acquired resistance to pharmacological treatments, due also to a plasmacellular clonal heterogeneity.

The prospective study will involve a patient cohort with MGUS, MM smouldering and MM, with the aim to characterize different transcriptional and epigenetic features, also including miRNAs, among MM cells susceptible or resistant to conventional therapies. The final goal is to identify new prognostic and predictive biomarkers that could be used as therapeutic tools to improve clinical targeted therapies.


Eligibility criteria: Inclusion Criteria:

- Compare Transcriptomics and epigenetic profile

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Transcriptomics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples
timeFrame: 12 months
measure: Epigenetics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Regina elena Cancer Institute
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Maurizio Fanciulli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02308436: Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide
Official title: Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide: a Mono-centre, Not-controlled. Not Blinded, Not-randmised in Situ Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Erosion of Teeth, Unspecified
Lead sponsor: Mibelle AG
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In vitro results showed a protective effect against acids for the mouthwash containing Curolox™ peptide. The goal of this in situ study is to detect the Curolox™ peptide under natural oral conditions on the tooth surface and to proof the in vitro results obtained. So far there are no effect and safety data of the Curolox™ mouthwash under natural oral conditions available.

Detailed description: The primary objective of the study is the detection of the Curolox™ peptide on the bovine enamel sample (proof-of-concept) under in vivo conditions after rinsing with the peptide-containing mouth wash.

Secondary Objectives

The secondary objectives of the study are:

1. safety and tolerance of the mouthwash in participants
2. identification of the duration the Curolox™ peptide is present on the bovine tooth surface under in vivo conditions
3. identification of the most effective mouthwash rinsing volume (2.5 mL or 5 mL)
4. prophylactic effect of multiple applications of the mouthwash confirmation of the prophylactic effect of the Curolox™ peptide obtained in in vitro study

Eligibility criteria: Inclusion Criteria:

* Willing and able to understand and to follow the study procedures and instructions
* Willing to wear a dental appliance for 7 days
* Willing and able to attend the on-study visits
* Good oral hygiene throughout the study
* Written informed consent before participation in the study

Exclusion Criteria:

* Volunteer with an active periodontal disease or periodontal surgery \< 1 year prior to study participation
* Volunteer with hypersensitive teeth or with any other (painful) oral pathology or defect
* Volunteer with an orthodontic appliance
* Volunteer undergoing a medical treatment
* Volunteer who is allergic to dental products
* Pregnant and lactating woman
* Concurrent participation in another clinical trial

Primary outcomes:
measure: Detection of Curolox peptide by mass spectroscopy
timeFrame: Immediately after rinsing with the mouthwash
Secondary outcomes:
measure: Detection of Curolox peptide by mass spectroscopy
timeFrame: 12 hours, 24 hours, 48 hours, 96 hours
Other outcomes:
Locations:
city: Brunnen
country: Switzerland
facility: Aeskulap Klinik
Study officials:
affiliation: Aeskulap Klinik
name: Christian Besimo, Dr.med.dent.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aeskulap Klinik / PZZN
name: Ulrich P. Saxer, Dr.med.dent.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02201836: The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma
Official title: The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The onset of asthma is particularly frightening for children. When the symptoms of asthma decrease, children and parents forget about the maintenance and control of breath and lung volume. Because adherence is so poor, asthma is known as the emergency room illness. The playing of a wind instrument is a unique way to provide a creative means for children and teens to understand both the impact of diaphramatic breathing and their ability to control it as well. This study builds upon the evidence, though sparse, that suggest that the blowing of a wind instrument with clinical music therapy intervention strengthens the muscles of breathing and fortifies the incentive toward attending to the daily symptoms and general management of asthma.


Eligibility criteria: Inclusion Criteria:

* between the ages of 7 and 18
* diagnosed with asthma

Exclusion Criteria:

* over 18

Primary outcomes:
measure: Quality of Life
timeFrame: 6 months
Secondary outcomes:
measure: Increase volume capacity
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Joanne Loewy, DA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00283036: APROVE : Irbesartan in Hypertension
Official title: Efficacy and Tolerability of Posology Adaptation of Irbesartan in Ambulatory Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-01-27
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients


Eligibility criteria: Inclusion Criteria:

* Patient with mild or moderate hypertension defined with arterial diastolic pressure (PAD) at sit position between 90 mmHg and 110 mmHg and arterial systolic pressure (PAS) at sit position between 140 mmHg and 180 mmHg.
* Patient diagnosed after 3 consultations within 2 months who has never been under treatment and responding to the required conditions for hypertension treatment with irbesartan. This patient must has been under proper but insufficient hygieno dietetic diet
* Patient who has been under a none satisfied antihypertensive treatment, and for whom this treatment was stopped at least 2 weeks prior to inclusion.
* Patient with a laboratory analysis (urinary sediment- Na -K- creatinine, total cholesterol) and ECG during the month prior to inclusion.

Exclusion Criteria:

* Severe Hypertension defined by PAS \> 180mmHg and/or PAD \> 110 mmHg.
* Isolated systolic Hypertension
* Secondary Hypertension
* Arterial stenosis on unique kidney - arterial bilateral kidney stenosis
* Non-surgically sterilized women or non-menopaused women.
* Confirmed sodic depletion.
* Hypersensitivity to Irbesartan.

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

Primary outcomes:
measure: Arterial Tension
measure: Tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: Alger
country: Algeria
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Nabil BENOUNICHE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02898636: Identification of Biomarkers in the Legal Medical Skin Wounds
Official title: Identification of Protein Markers of Vitality in Skin Wounds by Forensic Multiplex Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Legal Medical Skin Wounds
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient undergoing a forensic autopsy

Brief summary: Identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

Detailed description: Determining the vitality of skin wounds, that is to say their antemortem character, is an important issue in forensic pathology. The only criterion vitality currently recognized (but whose diagnostic performance remains limited) is the microscopic demonstration of an inflammatory infiltrate of neutrophils. The search for more reliable diagnostic biomarkers is required. By their early expression of the injury site, inflammatory cytokines are potential candidates and their quantification in injured skin could optimize the diagnosis of vitality injury.

The objective is to identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

Eligibility criteria: Inclusion Criteria:

* Adult died 18 years or more
* Having at least one recent ante-mortem skin wound (occurring less than 4 hours prior to death)
* Hours of death and the establishment of the ante-mortem wound known (date, hours and minutes)

Exclusion Criteria:

* Immunocompromised patients (HIV infection, immunosuppressive therapy ...)
* Putrefaction signs (abdominal patch of green ...)

Primary outcomes:
measure: measures cytokines
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: PEYRON
Study officials:
affiliation: University Hospital, Montpellier
name: Pierre-Antoine PEYRON, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01303536: Ondansetron Augmentation in Treatment-resistant OCD
Official title: Ondansetron Augmentation in Treatment-resistant OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Institute of Neuroscience, Florence, Italy
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms among obsessive compulsive disorder resistant patients.


Eligibility criteria: Inclusion Criteria:

* a diagnosis of OCD established by clinical interview with a licensed psychiatrist;
* a score of ≥ 24 at the Yale Brown Obsessive Compulsive Scale
* a Clinical Global Inventory score ≥ 4, after over 12 weeks of treatment with an adequate trial of an selective serotonin reuptake inhibitor at a moderate to high dose

Exclusion Criteria:

* diagnoses of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, current substance dependence or abuse, and current major depressive episode preceding the onset of obsessive compulsive disorder
* undergoing concomitant behavior therapy
* or having significant cardiovascular, hepatic, renal or pulmonary diseases

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: baseline
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: week 2
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: week 4
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: week 6
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: week 8
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: week 10
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: week 12
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: week 14
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: week 16
Secondary outcomes:
measure: The Drug Effect scale
timeFrame: week 0
measure: The Drug Effect scale
timeFrame: week 2
measure: The Drug Effect scale
timeFrame: week 4
measure: The Drug Effect scale
timeFrame: week 6
measure: The Drug Effect scale
timeFrame: week 8
measure: The Drug Effect scale
timeFrame: week 10
measure: The Drug Effect scale
timeFrame: week 12
measure: The Drug Effect scale
timeFrame: week 14
measure: The Drug Effect scale
timeFrame: week 16
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Institute of Neuroscience
Study officials:
affiliation: University of Florence
name: Stefano Pallanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01987336: A Prospective Analysis of Biofilm in Urinary Catheters Study
Official title: A Prospective Anaylsis of Biofilm in Urinary Catheters Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Standard Foley Catheter
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who require a standard foley catheter.

Brief summary: To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A 30cc urine sample would also be collected from the same subject, and analyzed.

Detailed description: After obtaining informed consent, concurrent with the changing of the Foley catheter in the clinic, would be obtaining a 30 cc. sample of urine which would also be fast frozen and stored in a -81 degree freezer until shipped to the Venter clinic on dry ice.

Eligibility criteria: Inclusion Criteria:

1. Subject must be 18 years of age.
2. Subject is attending weekly office visits at SW Wound Care Center as an out- patient.
3. Subject must have an indwelling Foley catheter.
4. Subject is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment.
5. Subject is willing and able to comply with all specified care and visit requirements.

Exclusion Criteria:

1. Subject refuses to participate in the study. 2. Subject is expected to be non-compliant. 3. Subject is a resident in a nursing home, or institutionalized. 4. Subject is pregnant. 5. Subject has a Legally Authorized Representative

-

Primary outcomes:
measure: To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter.
timeFrame: Over a period of 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall Wolcott, M.D.
role: PRINCIPAL_INVESTIGATOR
References: