louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00420134: Improvement of Liver Function in Liver Cirrhosis Patients After Autologous Mesenchymal Stem Cell Injection:a Phase I-II Clinical Trial
Official title: A Phase One/Two Clinical Trial on the Use of Autograft Mesenchymal Stem Cells Differentiated Into Progenitor of Hepatocytes for the Salvage Treatment of Patients With End-stage Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Failure
Cirrhosis
Keywords: mesenchymal stem cell
end stage liver disease
Cirrhosis
stem cell therapy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Tarbiat Modarres University
First posted: 2007-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The methods for separation of mesenchymal stem cell were established in 2001. These cells can differentiate to osteocytes, hepatocytes, chondrocytes, myocytes and etc,. In this study the investigators try to separate mesenchymal stem cell from end stage liver disease, then these cells will be differentiated to progenitor of hepatocytes, finally , the investigators injected these cells into portal vein under ultrasound guide. The investigators determine the effects of injected cells in reestablishment of liver function.


Eligibility criteria: Inclusion criteria:

* MELD score of at least 10
* Patent portal vein on color Doppler examination of the liver
* Normal alpha-feto protein serum levels
* Age more than 18
* Filling inform consent by patients and first degree family members

Exclusion criteria:

* Any evidence of hepatocellular carcinoma on liver ultrasound studies
* Patients want to exclude from study

Primary outcomes:
measure: Liver function test
measure: MELD score
Secondary outcomes:
measure: Cirrhosis mortality after 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Research Center for Gastroenterology and Liver Diseases
city: Tehran
country: Iran, Islamic Republic of
facility: Research center of Gastroenterology and Liver Disease
Study officials:
affiliation: Research center of Gastroenterology and Liver Disease
name: Mohammad Reza Zali, MD
role: STUDY_CHAIR
affiliation: Research Center for Gastroenterology and Liver Diseases
name: Pedram Kharaziha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02459717: Pre-biotics and Probiotics for Constipation in Parkinson's Disease
Official title: Double Blind, Placebo-controlled Trial of a Fermented Milk Containing Multiple Probiotics Strains and Prebiotic Fiber for Constipation Associated With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Fondazione Mondino
name: Istituti Clinici di Perfezionamento di Milano
First posted: 2015-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have been investigated and are now available for the management of constipation in PD. Preliminary data have suggested that probiotics could be help improving bowel habits but high-quality randomized trials are required in this area. Therefore, the investigators designed a randomized trial to evaluate whether the use of a fermented milk containing multiple probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD compared to placebo.


Eligibility criteria: Inclusion Criteria:

* diagnosis of constipation according to Roma III criteria
* complete bowel movements per week \<3
* total bowel movements per week \<6
* written informed consent

Exclusion Criteria:

* report of loose (mushy) or watery stool in the absence of laxative use
* ongoing artificial nutrition
* lactose intolerance
* chronic inflammatory bowel disease
* previous abdominal surgery
* use of anti-cholinergics
* use of antibiotics in the 6 weeks before baseline visit
* Radio- chemotherapy
* Cognitive decline (Mini Mental State Examination \<27)

Primary outcomes:
measure: Complete bowel movements
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of bowel movements
timeFrame: 4 weeks
measure: Stool consistency
timeFrame: 4 weeks
measure: Laxative use
timeFrame: 4 weeks
measure: Treatment satisfaction
timeFrame: 4 weeks
measure: Treatment continuation
timeFrame: 4 weeks
measure: Increase in one or more complete bowel movements
timeFrame: 4 weeks
measure: Frequency of three or more complete bowel movements
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Istituto Neurologico Mondino
Study officials:
affiliation: IRCCS Istituto Neurologico Mondino
name: Claudio Pacchetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barichella M, Pacchetti C, Bolliri C, Cassani E, Iorio L, Pusani C, Pinelli G, Privitera G, Cesari I, Faierman SA, Caccialanza R, Pezzoli G, Cereda E. Probiotics and prebiotic fiber for constipation associated with Parkinson disease: An RCT. Neurology. 2016 Sep 20;87(12):1274-80. doi: 10.1212/WNL.0000000000003127. Epub 2016 Aug 19.
Clinical trial NCT00459017: The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension
Official title: The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: 24 hour ambulatory blood pressure measurement
Mean blood pressure
Wrist manometer
Frequent measurement
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-04-11
Enrollment: 150
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: Despite knowledge regarding the importance of controlling patients' blood pressure (BP) only 30% of treated patients achieve BP goals. Our objective was to determine the effect of frequent self measurements of BP in the patients' natural environment as a mean to improve BP control. Our hypothesis was that frequent measurements of BP will reduce mean BP levels.


Eligibility criteria: Inclusion Criteria:

* Signing an informed consent form
* Having a diagnosis of hypertension for more than one year according to patients'records.
* receiving at least one medication for hypertension
* A reasonable understanding of Hebrew
* An ambulatory state enabling regular visits to a primary physician in the community and self-measurement of hypertension using the electronic device

Exclusion Criteria:

* Lack of willingness to participate in the study.Known arrhythmia
* Malignant disease
* Poor understanding of Hebrew

Primary outcomes:
measure: Meam blood pressure
Secondary outcomes:
measure: Satisfaction
measure: Quality of life
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Kupat Holim Meuhedet
Study officials:
affiliation: Sheba Medical Center
name: Yasmin Maor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02068417: Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)
Official title: A Prospective, Randomised, Blinded, Placebo-controlled Pilot Study of the Treatment of Erectile Dysfunction With Extracorporeal Shockwave Therapy (ESWT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: IIEF score
ED
Lead sponsor: Storz Medical AG
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 40
Sex: MALE
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 objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.


Eligibility criteria: Inclusion Criteria:

* Erectile dysfunction for more than 6 months
* Informed consent
* Positive effect of phosphodiesterase type 5 inhibitor (PDE5i)
* IIEF-15 score less than 20
* No neurological disease
* Stable partnership for more than 3 months
* Age 18-75

Exclusion Criteria:

* Total prostatectomy
* Another reason for ED except for vascular disorder
* Clinically significant hematological disease
* Heart stroke, Arrythmia during the last 6 months
* Cancer during the last 5 years
* Intake of antiandrogen
* ED treatment with the last 7 days
* IIEF score higher than, equal to 20
* Previous shockwave treatment

Primary outcomes:
measure: Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)
timeFrame: up to 6 months post treatment
Secondary outcomes:
measure: Quality of erection (Quality of Erection Questionnaire)
timeFrame: At screening, 1, 3 and 6 months post treatment
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Bethanien Krankenhaus Chemnitz gemeinnützige GmbH
Study officials:
References:
Clinical trial NCT06961617: Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
Official title: Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Lion TCR Pte. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing GoBroad Hospital
First posted: 2025-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventional treatment.


Eligibility criteria: Inclusion Criteria:

* HCC diagnosis confirmed by histology/ cytology or clinically
* HCC that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
* Has failed at least one line of systemic therapy for HCC
* ECOG performance status ≤1
* Serum HBsAg positivity
* Child-Pugh A (5 - 7 points)
* Life expectancy of at least 1 year
* HLA profile: HLA-A\*02:01 or HLA-A\*24:02

Exclusion Criteria:

* Brain metastasis
* Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors
* Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, TKI therapy, and immunotherapy.
* Use of any investigational product (IP) or investigational medical device within 28 days of study drug administration
* Serum HBV DNA levels ≥ 200 IU/ml at screening
* Serum HBsAg levels ≥ 10,000 IU/ml at screening
* Women who are pregnant or breast-feeding

Primary outcomes:
measure: Assessments of adverse events/serious adverse events
timeFrame: Start of treatment until 28 days post last dose
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: Up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gaobo Boren Hospital
Study officials:
affiliation: Lion TCR Pte. Ltd.
name: Tina Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT01109017: Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
Official title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 387
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with growth hormone deficiency including newly-diagnosed patients, who are considered to need treatment with Norditropin® (somatropin) or already on therapy with Norditropin® (somatropin) are eligible for inclusion in the study

Brief summary: This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.


Eligibility criteria: Inclusion Criteria:

* Severe adult growth hormone deficiency

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Previous participation in the study
* Diabetes Mellitus
* Presence of malignant tumor(s)
* Pregnant or likely to get pregnant

Primary outcomes:
measure: Number and type of suspected serious adverse drug reactions (SADRs) during the study period
timeFrame: after 5 years
Secondary outcomes:
measure: Number of impaired glucose tolerance events during the study period
timeFrame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
measure: Number of other types of adverse events (AEs) during the study period
timeFrame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
measure: Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)
timeFrame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
measure: Effects of insulin-like growth factor-1 (IGF-I) levels
timeFrame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00323817: To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Functional Dyspepsia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2006-05-10
Enrollment: 282
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: To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia


Eligibility criteria: Inclusion Criteria:

* Subjects presenting diagnosis of FD as defined by the Rome II
* Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom

Exclusion Criteria:

-

Primary outcomes:
measure: Global subject Outcome Assessment
timeFrame: 12 month
Secondary outcomes:
measure: Individual symptom
timeFrame: 12 month
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Leuven University
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02206217: Myopia Control With the Multi-segment Lens
Official title: The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: HOYA Corporation (Tokyo, Japan)
First posted: 2014-08-01
Enrollment: 183
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can slow myopia progression in Hong Kong schoolchildren.

MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens

Detailed description: MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal spectacle lens which corrects distance refractive error and at the same time produces myopic defocus images on the retina for all distances. The myopic defocus aims at slowing down myopia progression. The purpose of this study is to investigate if the MS lens can slow myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly assigned to either treatment group (wear MS lenses) or control group (wear ordinary single vision lenses). Their cycloplegic refraction and axial length will be monitored every six months over 2 years. The changes in refractive errors and axial length in two groups will be compared.

Eligibility criteria: Inclusion Criteria:

* Age at enrolment: 8-13 year
* Spherical equivalent refractions (SER): -1.00 to -5.00 Dioptres (D)
* Astigmatism and anisometropia of 1.50 D or less
* Spectacle corrected monocular logMAR visual acuity: 0 or better
* Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria:

* any ocular and systemic abnormalities might affect visual functions or refractive development
* prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.

Primary outcomes:
measure: Cycloplegic Refraction Change in SER
timeFrame: Baseline and 2 years
Secondary outcomes:
measure: Axial Length
timeFrame: Baseline and 2 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Centre for Myopia Research, The Hong Kong Polytechnic University
city: Hong Kong
country: Hong Kong
facility: Centre for Myopia Research, The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Carly SY Lam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hong Kong Polytechnic University
name: Chi ho To, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29.
Clinical trial NCT02905617: Post Market Clinical Experience Study of Sientra 207 Breast Implants
Official title: Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Augmentation
Breast Revision-Augmentation
Keywords: Breast Augmentation
Breast Revision-Augmentation
Lead sponsor: Tiger Biosciences, LLC.
Sponsor class: INDUSTRY
First posted: 2016-09-19
Enrollment: 113
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who receive Sientra Silicone 207 Gel Breast Implants for primary augmentation or revision augmentation

Brief summary: A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants

Detailed description: This study is designed to prospectively collect surgeon and participant satisfaction with the Sientra 207 implants in primary and revision augmentation participants over a 12-month time frame.

Eligibility criteria: Inclusion Criteria:

1. Is a candidate for primary or revision breast augmentation and is at least 22 years of age,
2. Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12.

Exclusion Criteria:

1. Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery
2. Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.

Primary outcomes:
measure: Investigator Overall Satisfaction Questionnaire
timeFrame: 3 months
measure: Investigator Overall Satisfaction Questionnaire
timeFrame: 6 months
measure: Investigator Overall Satisfaction Questionnaire
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sientra, Inc.
state: California
Study officials:
affiliation: Sponsor GmbH
name: Sientra, Inc.
role: STUDY_DIRECTOR
References:
citation: Schwartz MR, Haws MJ, Phillips G. Results of the Postmarket Clinical Study of the Sientra 207 Highly Cohesive Gel Breast Implants in Primary and Revision Augmentation. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):40S-48S. doi: 10.1097/PRS.0000000000004353.