louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03515915: Use Lay Language. HA Score to Identify Myeloma Patients Who Could Benefit From HDACi Treatment
Official title: Evaluating the Interest of GEP-based Derived Histone Acetylation Score to Identify Myeloma Patients Who Could Benefit From Treatment With HDAC Inhibitor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Recurrent or Refractory Multiple Myeloma
Keywords: multiple myeloma
HDAC inhibitor
Biomarker
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Poitiers University Hospital
First posted: 2018-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relapsed/refractory multiple myeloma

Brief summary: Panobinostat is a potent oral histone deacetylase inhibitor that alters gene expression through epigenetic mechanisms and inhibits protein degradation. It was recently approved by the US Food and Drug Administration for use in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma (MM) who have received ≥ 2 prior regimens, including bortezomib and an immunomodulatory drug.

A GEP-based histone acetylation score allowing identification of MM patients with a poor prognosis and who could benefit from HDACi treatment was recently reported(Moreaux et al. BJC. 2013).

Our hypothesis is that the histone acetylation score could be promising to identify MM patients who could benefit from treatment with HDACi and the development of personalized treatment.


Eligibility criteria: Inclusion Criteria:

* Relapsed/refractory multiple myeloma
* Aged 18 years or more with no upper age limit
* Have signed an informed consent

Exclusion Criteria:

NA

Primary outcomes:
measure: Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value
timeFrame: 1 day
Secondary outcomes:
measure: Progression free survival will be monitored.
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: JEROME MOREAUX, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03376815: Tumor Landscape Pathological Diagnosis by Large Tissue Sections
Official title: Tumor Landscape Pathological Diagnosis by Large Tissue Sections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pathology
Keywords: Tumor ,landscape ,pathological diagnosis
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ZhongShan Hospital，FuDan University

Brief summary: The aim of this study is to establish large tissue sections for 10 kinds of tumors. in order to observe the tumor landscape on microscope. The tumors including esophageal carcinoma,gastric carcinoma,hepatocellular carcinoma etc.200 cases of each tumor will be compared by traditional sample method and landscape sample method to testify the clinical value and significance of tumor landscape pathological diagnosis .


Eligibility criteria: Inclusion Criteria:

1. Older than 15-year-old
2. Did not receive preoperative preoperative chemotherapy or radiotherapy

Exclusion Criteria:

patients undergoing preoperative chemotherapy or radiotherapy

Primary outcomes:
measure: Prostate，traditional and landscape sample method
timeFrame: 1st January, 2018 ~30th June, 2018
measure: liver,traditional and landscape sample method
timeFrame: 1st January, 2018 ~30th June, 2018
measure: esophageal,traditional and landscape sample method
timeFrame: 1st January, 2018 ~30th June, 2018
measure: GIST,traditional and landscape sample method
timeFrame: 1st July, 2018 ~31st December, 2018
measure: colorectal,traditional and landscape sample method
timeFrame: 1st July, 2018 ~31st December, 2018
measure: pancreatic,traditional and landscape sample method
timeFrame: 1st July, 2018 ~31st December, 2018
measure: lung, traditional and landscape sample method
timeFrame: 1st July, 2018 ~31st December, 2018
measure: renal,traditional and landscape sample method
timeFrame: 1st July, 2018 ~31st December, 2018
measure: breast,traditional and landscape sample method
timeFrame: 1st July, 2018 ~31st December, 2018
measure: cervical,traditional and landscape sample method
timeFrame: 1st July, 2018 ~31st December, 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03600415: Acute Exposure to High Altitude on Blood and Tissue Oxygenation (ABGA, NIRS)
Official title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: High Altitude
arterial blood gas analysis
near infrared spectroscopy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Including a baseline assessment and assessments at Low altitude and High altitude
Primary purpose: PREVENTION

Brief summary: Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) on blood and tissue oxygenation (ABGA, NIRS).

Detailed description: Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

At rest and under exercise data from ABGA and NIRS will be compared at low altitude and High Altitude.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Arterial blood oxygenation at High Altitude (2500m above sea level)
timeFrame: within 5 hours
Secondary outcomes:
measure: Near infrared spectroscopy at High Altitude (2500m)
timeFrame: within 5 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00207415: A Comparison of the ASHC and CDSMP
Official title: A Comparison of the ASHC and CDSMP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: arthritis
self management
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of Illinois at Chicago
First posted: 2005-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research study is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The University of Illinois Project is emphasizing recruiting a balance of uran and rural participants. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.


Eligibility criteria: Inclusion Criteria:

Adult with self reported arthritis-

Exclusion Criteria:

-

Primary outcomes:
measure: Health status at 6 month follow up
measure: Health Care utilization at 6 month follow up
Secondary outcomes:
measure: self management behaviors at 6 month follow up
measure: self efficacy at 6 month follow up
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois College of Medicine Rockford
name: Mary Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05469815: Lost Children Society (LCS), Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients
Official title: Lost Children Society (LCS), Metacognitive Training Integrated Into an Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients : a Pilot Study on Feasibility
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Schizophrenia
Keywords: Metacognitive Training
Early-onset Schizophrenia
Therapeutic TableTop Role Playing Game
Psychoeducational program
Lost Children Society
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Lost Children Society (LCS) is a Therapeutic TableTop Role-Playing Game specifically developed for early-onset schizophrenia patient.

It is performed online via a secure teleconsultation and videoconference platform.

Patients are connected from their home, on their personal computer or tablet, equipped with headsets with microphone.

This study aims to validate the feasibility of this online Therapeutic TableTop Role Playing Game.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of early onset schizophrenia
* Patient who has the capacity to understand the protocol and to perform evaluations
* Written informed consent to participate in the study given by the patient or by the parental authority of the minor patient.
* Patient with social security coverage

Exclusion Criteria:

* Intelligence quotient\<70 on Wechsler Adults Intelligence Scale-IV (for 17+ years) or the Wechsler Intelligence Scale for Children V (for 15-16 years).
* Personal history of head trauma, neurological disorder, genetic disease.
* Co-morbidities: major depressive episode or post-traumatic stress disorder unresolved or resolved within the last 6 months.
* Lack of mastery or access to a computer or personal tablet in autonomy
* Therapeutic history of metacognitive training.
* Patient under guardianship, curators or legal protection
* Patient going through a period of exacerbation of positive or negative psychotic signs likely to lead to a full-time hospitalization in a specialized environment within the next 3 months

Primary outcomes:
measure: Overall feasibility of the Game
timeFrame: 10 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: EPSM de Vendée Georges Mazurelle
name: Jonathan PIONNIER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00845715: Early Range of Motion Following Arthroscopic Rotator Cuff Repair
Official title: The Effect of Early Range of Motion on Clinical Outcomes, Patient Satisfaction, and Cuff Integrity Following Arthroscopic Rotator Cuff Repair. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Disease
Keywords: rotator cuff
rehabilitation
range of motion
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Donaghue Medical Research Foundation
First posted: 2009-02-18
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 investigate whether there is a difference in the quality of life, ability to return to functioning (back to everyday life), the amount of experienced pain in patients who immediately move their shoulder versus patient who delay moving their shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a difference in the healing rates between these two groups.


Eligibility criteria: Inclusion Criteria:

* patients who are between 18 years and 70 years of age
* full thickness rotator cuff tear on ultrasound and MRI
* failed conservative management

Exclusion Criteria:

* concomitant pathology including massive rotator cuff tears that extend into the subscapularis or the teres minor and all co-existing labral pathology
* history of neuromuscular or degenerative disease

Primary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: 6 month post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Augustus D Mazzocca
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06932315: A Study to Evaluate the Safety, Tolerability and Dose-Response Relationship of HRS-9190 in Healthy Subjects
Official title: A Study to Evaluate the Safety, Tolerability and Dose-Response Relationship of HRS-9190 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Skeletal Muscle Relaxation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, open-label and dose-escalation study to evaluate the safety, tolerability and dose-response relationship of HRS-9190 in healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female subjects aged 18 to 45 years (inclusive).
2. Subjects must have no pregnancy plans for the next three months and agree to use highly effective contraception throughout the trial period.
3. Capable of understanding the study requirements and willing to provide written informed consent.

Exclusion Criteria:

1. Presence of any clinically significant condition that could interfere with trial participation.
2. History or current diagnosis of neuromuscular disorders.
3. Major surgery within 6 months pre-screening, or planned surgical procedures during the study.
4. Vaccination received within 1 month prior to screening or planned vaccination during the trial period.
5. Participation in another investigational drug trial within 3 months pre-screening.
6. Clinically significant abnormalities in screening/baseline physical examinations.
7. Positive alcohol breath test at screening.
8. Pregnancy or lactation status (for female subjects).
9. Investigator-determined unsuitability for study participation or predicted protocol non-compliance.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: From the ICF signing date to Day 7.
Secondary outcomes:
measure: The maximum observed concentration of HRS-9190 (Cmax)
timeFrame: 0 hour to 1.5 hours after administration.
measure: Time to Cmax of HRS-9190 (Tmax)
timeFrame: 0 hour to 1.5 hours after administration.
measure: Terminal elimination half-life of HRS-9190 (t1/2)
timeFrame: 0 hour to 1.5 hours after administration.
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT05665985: Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
Official title: Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a Randomized Controlled Trial (RCT) with 30 research samples divided into two groups, containing 15 samples each for the treatment group and 15 for the control group. The treatment group was given Moringa oleifera extract of 40.50 mg/KGBW/day, while the control group was given a placebo for 30 days. The degree of disease activity (DAS28-CRP, DAS28-LED) was assessed before and after the intervention. Intervention with Dry Extract of Moringa Oleifera (trade name is Keloreena Ⓡ , registered number in National Food and Drug Registry: 193332021) The dose given is 1000 mg bi in day for 30 days. Inclusion criteria are Female patients, 18-60 years, who met the RA criteria according to the ACR / EULAR 2010 and VAS\> 3. Exclusion criteria are Pregnant, using Methylprednisolone\> 8 mg per day, using NSAIDs, and having comorbidities
Primary purpose: TREATMENT

Brief summary: Intervention therapy study of moringa oliefera extract on the degree of activity of rheumatoid arthritis patients. The research subjects were patients with rheumatoid arthritis-intervention with moringa oliefera for 30 days.

Detailed description: Rheumatoid arthritis is a progressive autoimmune disease. Delay in therapy and delay in remission will result in disability. This study is a randomized clinical trial using a new drug for rheumatoid arthritis, moringa oliefera. The choice of moringa oliefera was due to the ability of moringa oliefera in anti-inflammatory and immunosuppressant terms. This drug has also been proven in experimental studies on rheumatoid arthritis animals. This study with 30 research samples divided into two groups, containing 15 samples each for the treatment group and 15 for the control group. The treatment group was given Moringa oleifera extract of 40.50 mg/KGBW/day, while the control group was given a placebo for 30 days.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of RA criteria according to the ACR / EULAR 2010
* Visual analog score of more than three.

Exclusion Criteria:

* Pregnancy
* Using Methylprednisolone\> 8 mg per day
* Using NSAIDs
* Chronic Kidney Disease
* Diabetes Mellitus
* Heart Failure
* Lever disease

Primary outcomes:
measure: DAS-28 CRP
timeFrame: pre and post intervention (30 day)
measure: DAS-28 ESR
timeFrame: pre and post intervention (30 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Surakarta
country: Indonesia
facility: RS UNS (Universitas Sebelas Maret Hospital)
state: Central Java
Study officials:
References:
Clinical trial NCT03584685: Impact of the Surgical Mask on the Patient-nurse Relation in Primary Care
Official title: The Impact of the Surgical Mask on the Relationship Between Patient and Family Nurse in Primary Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Satisfaction, Personal
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All participants will initially be treated without the surgical mask. Then, half will be treated with the mask and the other half will be treated without the mask.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to inspect the effect of nurses wearing the surgical mask on their patients' satisfaction with the relationship. All participants will initially be treated without the mask. Then, half will be treated with the mask and the other half will be treated without the mask.

Detailed description: The use of the surgical mask has well-known benefits for both the patient and the professional regarding the control of infection contamination. However, its use is left to individual criteria, and is passed on from generation to generation of nurses through experiential, intuitive knowledge. Studies are necessary to support the use of the surgical mask.

Research indicates that wearing the mask affects perception of words, thus influencing patient-nurse communication. However, it might also affect the very nurse--patient relation. For example, it can convey the idea of personal distancing, which can either be appreciated by patients as dutiful professional care by the nurse, or viewed as a limit imposed on interpersonal communication and on the relationship.

This study inspects patient satisfaction about (1) interpersonal aspects and (2) professionalism in the patient-nurse relationship when the mask is used.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from chronic wounds
* Age: 18 years or older
* Know how to read and write in Portuguese
* Confirmed autopsychic and allopsychic orientation
* Maintain previous relation with the nurse of at least 18 months
* Need at least two consecutive treatments with the nurse

Exclusion Criteria:

* Failing to meet the above criteria

Primary outcomes:
measure: 30-item questionnaire assessing patient satisfaction with the nurse-patient relation (the PSQ-III)
timeFrame: 1 day
Secondary outcomes:
measure: Sensation of time
timeFrame: 1 day
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: CINTESIS - Faculty of Medicine of the University of Porto
Study officials:
affiliation: CINTESIS, Faculty of Medicine, University of Porto
name: Irene P Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References: