louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03590886: Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
Official title: A Clinical Study About Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Biliary Cirrhosis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary biliary cholangitis patients

Brief summary: To compare intestinal flora diversity in different PBC patients with UDCA responses, and further study the differences of bile acid metabolism and short chain fatty acid metabolism in feces and serum of two groups of PBC patients.

Detailed description: The PBC patients have been enrolled in the study for UDCA treatment more than 1 year, who is divided into the UDCA total response Group and the other poor response group according to Paris-I/II standard .The feces of two groups of patients were collected and the differences of microbial polymorphism of fecal microorganism in two groups were observed. The metabolic differences of bile acids and short chain fatty acids in serum and feces of two groups of PBC patients were studied by means of metabolic proteomics.

Eligibility criteria: Inclusion Criteria:

1.Confirmed diagnostic criteria about PBC, and orally UDCA treatment for more than a year; 2.30-70 years old; 3.Currently only UDCA therapy, not glucocorticoids and immunosuppressor treatment.

Exclusion Criteria:

1. Viral liver disease;
2. alcoholic liver disease;
3. fatty liver;
4. drug-associated liver damage;
5. infectious disease;
6. obesity;
7. gastrointestinal diseases;
8. combined with other autoimmune diseases;
9. cardiac and pulmonary dysfunction;
10. renal dysfunction, malignant tumor,;
11. neurological and psychiatric abnormalities;
12. nearly 2 months to take antibiotics and probiotics;
13. nearly 3 months participate in other drug clinical trials .

Primary outcomes:
measure: fecal microbial diversity
timeFrame: 6 months
Secondary outcomes:
measure: bile acid metabolites
timeFrame: 6 months
measure: short chain fatty acid metabolites
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affliated Hospital of Sun Yat-sen University
name: Lin B Liang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01756586: Dexamethasone and Lower Extremity Block Duration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Analgesia Duration
Keywords: popliteal block
analgesia duration
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-12-27
Enrollment: 4
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: Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75
2. foot surgery
3. no contraindication to regional anesthesia

Exclusion Criteria:

1. opioid dependent
2. chronic pain condition
3. peripheral neuropathy

Primary outcomes:
measure: Increase in the Duration of Block
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT01707186: Pictorial Representation of Illness and Self Measure
Official title: Pictorial Representation of Illness and Self Measure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2012-10-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis from hospital clinics

Brief summary: PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the mid-1990s; the task was first developed as a simple measure of how a person was coping with his or her experience of illness. This is an international, multicentre study to evaluate the PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges, Montreal and Queensland. The study will recruit 200 patients in total.

In addition to the procedures for the patient's routine clinical visit, the patients will be invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be asked to attend 3 times over 24 weeks


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Written confirmed diagnosed of rheumatoid arthritis

Exclusion Criteria:

* A diagnosis of any of the following:
* Multiple sclerosis
* Motor neurone disease
* Parkinson's disease
* Alzheimer's disease
* Depression or anxiety disorders as identified using the Patient depression screening questions from the patient health questionnaire 9 (PHQ9).

Primary outcomes:
measure: PRISM/PRISM+
timeFrame: 30 September 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
Study officials:
affiliation: University of Oxford
name: Peter Taylor, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02981186: Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)
Official title: Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacity
Keywords: Intraocular Lens
trifocal
cataract
PhysIOL
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a prospective randomised controlled study. The patients get monolateral IOL implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs consisting of the same optical design. The difference between the IOLs is the material (hydrophilic and hydrophobic).

To decide which eye receives POD F and which eye receives POD F GF, a randomization table will be provided to the principle investigator.

Detailed description: The examinations consist of visual acuity data, contrast sensitivity exams and slitlamp examinations.

Follow up will be up to 6 months postoperative.

Eligibility criteria: Inclusion Criteria:

* Cataractous Eyes with no comorbidity
* Patient older than 50 years old
* Regular corneal astigmatism \<0.75 dioptres by an automatic keratometer (regularity determined by the topography of the keratometry) or \<1.0 dioptres if the steep axis of cylinder is between 90° and 120°
* Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Unrealistic expectation
* Irregular astigmatism
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)

Primary outcomes:
measure: Visual Acuity at far, near and intermediate distance
timeFrame: 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University - Department of Ophthalmology
Study officials:
affiliation: Semmelweis University - Department of Ophthalmology
name: Zoltan Nagy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01014286: Lung Cancer Mutation Consortium Protocol
Official title: Lung Cancer Mutation Consortium Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenocarcinoma of Lung, Stage IV
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-11-16
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage IV adenocarcinoma of the lung who have undergone biopsy with remnant tissue

Brief summary: The primary objective of this protocol is to determine the frequency of oncogenic mutations in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational analyses will be used to determine the frequency of each mutation, its association with clinical features and outcome, and its association with other mutations. As future therapeutic protocols specific for these mutations are developed, patients may be notified of their eligibility for these studies. Future translational studies may be used to: a) unravel the complex biology of lung cancer; b) identify prognostic markers; c) define predictive markers of response/resistance to new therapies; d) identify new targets. A secondary goal is to establish a consortium of sites that have the capability of conducting multiple mutation testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.


Eligibility criteria: Inclusion Criteria:

1. Subjects (=\> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of advanced adenocarcinoma of the lung.
2. Diagnosed May 2012 or later
3. Oral and written informed consent.

Exclusion Criteria:

1. Lung cancer histologies other than adenocarcinoma
2. Lack of adequate tissue.

Primary outcomes:
measure: Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
timeFrame: Five years
measure: Rate of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
timeFrame: Five years
Secondary outcomes:
measure: Associations between each mutation and clinical outcomes.
timeFrame: Two years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver Cancer Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Paul Bunn, M.D.
role: STUDY_DIRECTOR
References:
citation: Kris MG, Johnson BE, Berry LD, Kwiatkowski DJ, Iafrate AJ, Wistuba II, Varella-Garcia M, Franklin WA, Aronson SL, Su PF, Shyr Y, Camidge DR, Sequist LV, Glisson BS, Khuri FR, Garon EB, Pao W, Rudin C, Schiller J, Haura EB, Socinski M, Shirai K, Chen H, Giaccone G, Ladanyi M, Kugler K, Minna JD, Bunn PA. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014 May 21;311(19):1998-2006. doi: 10.1001/jama.2014.3741.
Clinical trial NCT01504386: Transversus Abdominis Plane Block After Robot-assisted Laparocopic Hysterectomy
Official title: Effekt of Transversus Abdominis Plane (TAP) Block After Robot-assisted Laparocopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hysterectomy
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
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 the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after robot-assisted laparoscopic hysterecomy.


Eligibility criteria: Inclusion Criteria:

* Age 18-80
* BMI 17-40
* Written consent
* Can cooperate

Exclusion Criteria:

* Drug and alcohol abuse
* Consumption of opioids
* Drug allergy
* Infection at insertion point of needle

Primary outcomes:
measure: Total opioid consumption
timeFrame: 0-24 hours
Secondary outcomes:
measure: Pain during rest and cough
timeFrame: 1,2,4,8,18 and 24 hours
measure: Postoperative nausea and vomiting
timeFrame: 1,2,4,8,18 and 24 hours
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Univerity Hospital, Department of Anaesthesia
Study officials:
affiliation: Herlev University Hospital, Copenhagen
name: Henrik Torup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06571786: SHAPE for ICP Assessment
Official title: Subharmonic Aided Pressure Estimation (SHAPE) for Intracranial Pressure (ICP) Assessment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lumbar Puncture
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2024-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Subharmonic Aided Pressure Estimation (SHAPE) technique is a noninvasive ultrasound-based imaging technique that can estimate ambient pressure using subharmonic emissions from ultrasound contrast agents. Ultrasound contrast agents are encapsulated microbubbles (mean diameter \< 8 µm) with a lipid, protein, or polymer shell that traverse the entire vasculature. When the contrast microbubbles are insonated with relatively high acoustic pressures (\>100-150 kPa), these microbubbles act as nonlinear oscillators yielding energy components in the received echo signals at frequencies ranging from the subharmonic (half of transmit frequency) to higher harmonics and even ultraharmonics. Based on empirical evidence, the subharmonic signal exhibits a sigmoidal relationship with incident acoustic pressure i.e., subharmonic signal can be divided into occurrence, growth and saturation stages. In the growth stage, the subharmonic signal has shown sensitivity to ambient pressure characterized by an inverse linear relationship between subharmonic signal and ambient pressure changes. This inverse linear relationship forms the basis for the SHAPE technique. Several pre-clinical and clinical studies have been conducted to utilize the SHAPE technique for in vivo pressure estimation e.g., to diagnose portal hypertension, to estimate intra-cardiac pressures and to determine interstitial fluid pressures. The core imaging mode underpinning the SHAPE technology (subharmonic imaging) is now available on some commercial scanners. In the proposed pilot study, the SHAPE technique will be leveraged for monitoring intracranial pressure (ICP). The use of SHAPE technique for the ophthalmic artery could potentially provide an accurate noninvasive method of measuring ICP in patients with idiopathic intracranial hypertension (IIH) and other conditions of raised ICP, which would revolutionize the field.


Eligibility criteria: Inclusion Criteria:

* Scheduled for lumbar puncture to assess ICP pressures
* Age over 18.

Exclusion Criteria:

* Pregnant or nursing
* Medically unstable
* Allergy to any components of Definity.
* Unable to provide written informed consent

Primary outcomes:
measure: Comparing SHAPE to lumbar puncture pressure measurements
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01734486: Growth Response in Girls With Turner Syndrome
Official title: Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Genetic Disorder
Turner Syndrome
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 31
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.


Eligibility criteria: Inclusion Criteria:

* Turner syndrome
* If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age
* If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age
* Measured parental height available
* Written informed consent

Primary outcomes:
measure: Height gain, SDS (Standard Deviation Score)
measure: Height gain in cm
Secondary outcomes:
measure: Height
measure: Bone maturation
Other outcomes:
Locations:
city: Besancon
country: France
facility: Novo Nordisk Investigational Site
city: Bordeaux
country: France
facility: Novo Nordisk Investigational Site
city: Dunkerque
country: France
facility: Novo Nordisk Investigational Site
city: Grenoble
country: France
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: Lorient
country: France
facility: Novo Nordisk Investigational Site
city: NICE cedex 3
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Reims
country: France
facility: Novo Nordisk Investigational Site
city: Rennes
country: France
facility: Novo Nordisk Investigational Site
city: Rouen
country: France
facility: Novo Nordisk Investigational Site
city: Tarbes
country: France
facility: Novo Nordisk Investigational Site
city: TOULOUSE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Tours
country: France
facility: Novo Nordisk Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06578286: ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
Official title: Evaluate the Efficacy and Safety of ARX788 in Patients With HER2-positive Advanced Breast Cancer Whose Disease Has Progressed Following T-DXd Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.


Eligibility criteria: Inclusion Criteria:

1. 18 to 75 years old (including upper and lower limits), male or female;
2. Unresectable locally advanced, recurrent or metastatic BC;
3. Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
4. Received T-DXd treatment in the advanced stage;
5. Adequate bone marrow, liver, kidney and coagulation function;
6. Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.

Exclusion Criteria:

1. With meningeal metastases or disseminated brain metastases or active brain metastases;
2. Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
3. Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
4. Has cardiac insufficiency;
5. Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;

Primary outcomes:
measure: Objective remission rate (ORR)
timeFrame: Until progression, assessed up to approximately 24 months
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Baseline through end of study, assessed up to 24 months]
measure: Duration of relief (DOR)
timeFrame: Until progression, assessed up to approximately 24 months
measure: Progression-free survival (PFS)
timeFrame: Until progression or death, assessed up to approximately 36 months]
measure: Overall survival (OS)
timeFrame: Until death, assessed up to approximately 50 months
measure: The number of subjects experiencing adverse event TEAEs
timeFrame: Up to follow-up period, approximately 50 months
Other outcomes:
Locations:
Study officials:
References: