louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06979011: Construction of Clinical Diagnostic Model for Pulmonary Hypertension
Official title: Construction of Diagnostic Models for Pulmonary Hypertension Based on Novel Laboratory Indices and Echocardiogram Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
diagnosis
machine learning
heamodynamic status
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 199
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with all types of PH

Brief summary: Primary objective: To establish a non-invasive diagnostic model for pulmonary hypertension based on laboratory indicators and echocardiographic parameters.

Secondary objectives: To investigate the correlations between laboratory test indicators and echocardiographic data, and to develop new parameters based on preliminary analysis to assist in the diagnosis of pulmonary hypertension

Detailed description: Data collection:

Collect vital signs (age, sex, etc.), clinical laboratory tests (complete blood count, biochemistry, BNP, D-dimer, and related derived parameters), and echocardiographic data from both the control group and pulmonary hypertension (PH) patients.

Obtain hemodynamic data measured via right heart catheterization (RHC) in PH patients.

Model development:

Construct a clinical diagnostic model using laboratory and echocardiographic data.

Fit hemodynamic parameters of PH patients based on their laboratory indicators, then assess the hemodynamic status using the fitted parameters and compare with actual measurements.

Secondary analyses:

Investigate correlations between echocardiographic parameters and laboratory test indicators in PH patients.

Identify core variables to develop novel diagnostic parameters and evaluate their diagnostic performance.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with any subtype of pulmonary hypertension (PH) confirmed by right heart catheterization (RHC) between 2020 and 2025.

No gender restrictions; age \>18 years.

Availability of complete RHC records, transthoracic echocardiography (TTE), and laboratory test results (echocardiography and lab tests must be performed within one month before or after RHC).

Exclusion Criteria:

* Pulmonary veno-occlusive disease (PVOD)

Active or history of malignancy (or Malignant tumors if referring to current cases)

Hematologic disorders

Primary outcomes:
measure: AUC
timeFrame: from 1 Jan 2025 to 30 Apr 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01433211: Nutrition and Frailty in Older Persons
Official title: Relation Between Nutrition and Frailty in Community-dwelling Older Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2011-09-13
Enrollment: 206
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community-living persons aged 75 years or older

Brief summary: The purpose of this study is to investigate the association between nutrition and frailty in older community-living persons.

Detailed description: Nutrition is regarded as an important etiologic factor in the development of frailty in older adults. To date the relation between nutrition and frailty is only poorly described.

Thus, it is the purpose of this study to investigate the association between different nutrition characteristics and frailty in older community-living persons.

206 volunteers aged 75 years or older were included in this cross-sectional study. Nutritional assessment included the Mini-Nutritional Assessment (MNA), a food-frequency questionnaire and a standardised three-day dietary record. Intake of energy and nutrients was calculated using the German nutrient database BLS II.2. Dietary patterns were described by different dietary scores. Frailty was defined according to Fried et al. based on the following criteria: weight loss, exhaustion, grip strength, walking speed and physical activity. In addition several standardised tests were performed to characterise physical performance (Timed Up \& Go, repeated chair stands, balance tests).

The association between nutritional aspects and physical performance is evaluated in an explorative manner.

Eligibility criteria: Inclusion Criteria:

* age of 75 years and older
* living independently at home

Exclusion Criteria:

* acute illness
* cognitive impairment (Mini Mental State Examination ≥ 24 out of 30 points)

Primary outcomes:
measure: Frailty (according to Fried et al.)
timeFrame: 1 day
Secondary outcomes:
measure: Impaired physical performance (according to Guralnik et al.)
timeFrame: 1 day
Other outcomes:
Locations:
city: Nürnberg
country: Germany
facility: Institute for Biomedicine of Aging, University of Erlangen-Nürnberg
Study officials:
References:
citation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
citation: Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
Clinical trial NCT00987311: Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response
Official title: Pilot Study on the Effects of Probiotic Fermented Dairy Drinks on the Intestinal Immune Response in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Probiotics
intestinal immune system
human
healthy subjects
dairy drink
Healthy adults
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate whether two different fermented dairy drinks consumed daily could have an effect on the intestinal immune response in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male/female subjects aged from 18 to 45 years (bounds included).
* Subjects with none of the symptoms of gastrointestinal infectious diseases
* Subjects with a body mass index (BMI) between 19 and 30 kg/m² (bounds included).
* Subjects who accept to be submitted to an alimentary restriction of product with OTC and foods containing probiotics and/or prebiotics
* Subjects who regularly consume and appreciate dairy products
* Subjects who have not consumed any products or OTCs containing probiotics within the last three months.

Exclusion Criteria:

* Subjects in a situation that, in the investigator opinion, could interfere with optimal participation in the present study (e.g. non dairy-products consumer) or could constitute a special risk for the subject.
* Subjects with allergies or hypersensitivity to any component of the study product (e.g: allergy or hypersensitivity to milk proteins, or lactose intolerance)
* Subjects with any food allergy
* Subjects with auto-immune or with chronic disease or with a history of chronic metabolic or gastrointestinal.
* Subjects who have had any surgery or intervention requiring general anaesthesia in the last 4 weeks..
* Subjects with special diet requirements
* For female subjects: pregnancy, breast feeding or no method of contraceptive used
* Subjects participating in any other interventional study concomitantly or within 4 weeks of the study entry date.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05255211: Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
Official title: Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cognition
Keywords: Remimazolam tosilate
cognition
Old
Colonoscopy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2022-02-24
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy


Eligibility criteria: Inclusion Criteria:

1. ASA I\~II
2. patients will be treatmented by sedation under colonoscopy
3. sign informed consent

Exclusion Criteria:

(1) Preoperative depression and cognitive impairment

（2） Hearing or visual impairment;

（3） Drug abuse, alcoholism or long-term use of antidepressants;

（4） Cardiovascular and cerebrovascular accidents, neurological sequelae, or severe liver and kidney function damage occurred within 6 months

（5） BMI \< 18, BMI \> 30

（6） Confirmed or suspected allergy to the test drug

Primary outcomes:
measure: Mini-mental State Examination(MMSE) score 1
timeFrame: 5 minutes before procedure
measure: Mini-mental State Examination(MMSE) score 2
timeFrame: 30 minutes after colonoscopy when VAAS score>=4
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yongming Chen
state: Shanghai
Study officials:
References:
Clinical trial NCT03358511: Engineering Gut Microbiome to Target Breast Cancer
Official title: Engineering Gut Microbiome to Target Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal females ≥ 18 years of age
* Histologically confirmed adenocarcinoma of the breast ≥1.0 cm operable stage I-III
* Must have adequate organ function,
* Not receive systemic neoadjuvant therapy
* Be willing to provide tissue, blood, and stool samples for research study.
* Must not have taken any probiotics in the past 60 days prior to enrollment.

Exclusion Criteria:

* Patients with autoimmune disease, immune deficiency such as HIV, irritable bowel, known diverticulosis, and other serious GI conditions at treating physician's discretion will be excluded.

Primary outcomes:
measure: Mean number of cytotoxic T lymphocytes (CD8+ cells)
timeFrame: Approximately 4 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Saranya Chumsri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02170311: Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia
Official title: "Phase Ib Study of Z-213 in Subjects With Iron-deficiency Anemia - To Investigate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics -"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Iron Deficiency Anemia
Keywords: Z-213, Ferric carboxymaltose, Iron, Iron-deficiency-anemia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).


Eligibility criteria: Inclusion Criteria:

* Patients with mild iron deficiency anemia

Exclusion Criteria:

* Patients with anemia caused by conditions other than iron deficiency
* Patients with abnormal laboratory test values at screening for C-reactive protein, Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin
* Patients with liver, kidney or circulatory system disease
* Patients with a history or present illness that is a malignant tumor or autoimmune disease
* Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
* Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Primary outcomes:
measure: Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae).
timeFrame: 8days
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Zeria Investigative Site
Study officials:
affiliation: Zeria Pharmaceutical Co., Ltd
name: Zeria Investigator
role: STUDY_DIRECTOR
References:
Clinical trial NCT02166411: Laparoscopic Myomectomy Using Barbed or Conventional Sutures
Official title: Laparoscopic Myomectomy Using Barbed or Conventional Sutures . A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibroid
Keywords: Myomectomy ,Laparoscopy , Barbed sutures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .

Detailed description: • Till now , there is only one small randomized controllrd study (n=22 in each arm) which compared the use of barbed suture with conventional suture in laparoscopic myomectomy .The myoma bed was closed with either conventional polyglactin suture or unidirectional barbed suture . The operative time was shorter in the barbed suture group (73.3 ± 21.4 min Vs. 80.7 ± 18.6 min) but this difference failed to reach statistical significance because of small sample size . However, the time required to suture the myoma beds was significantly lower in the barbed suture group .

Eligibility criteria: Inclusion Criteria:

* the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm).

Exclusion Criteria:

* submucosal myoma
* calcified myomas
* uterine size more than 16 weeks
* suspension of genital malignancy
* coagulation defects or concurrent anticoagulant therapy
* pregnancy
* compromised cardiopulmonary status
* previous treatment with gonadotropin-releasing hormone analogue
* contraindications for general anesthesia.

Primary outcomes:
measure: Operative time
timeFrame: During myomectomy operation
Secondary outcomes:
measure: Suturing time of myoma bed
timeFrame: During myomectomy operation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Study officials:
affiliation: Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
name: Mohamed Zayed, M.D,PhD
role: STUDY_CHAIR
affiliation: Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
name: Usama M Fouda, M.D,PhD
role: STUDY_DIRECTOR
affiliation: Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
name: Khaled A Elsetohy, M.D,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
Clinical trial NCT00471211: Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease
Official title: A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Three-Group Study to Assess the Safety, Tolerability and Efficacy of Two Dose Levels of PBT2 to Slow Progression of Disease in Patients With Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Pranabio
Sponsor class: UNKNOWN
First posted: 2007-05-09
Enrollment: 80
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of PBT2 administered for 12 weeks compared to placebo in patients with early Alzheimer's disease treated with an acetylcholinesterase inhibitor.


Eligibility criteria: Inclusion Criteria:

* diagnosis of probable early Alzheimer's disease
* stable dose of acetylcholinesterase inhibitor
* community dwelling
* stable medical condition

Exclusion Criteria:

* unstable and significant medical conditions
* recurrent major psychiatric disorder
* treatment with memantine

Primary outcomes:
measure: Safety
timeFrame: Study duration
Secondary outcomes:
measure: Change from baseline in biomarkers; Change from baseline in cognitive and global function scales
timeFrame: Study duration
Other outcomes:
Locations:
city: Sydney
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Falkoping
country: Sweden
city: Kalix
country: Sweden
city: Kalmar
country: Sweden
city: Lund
country: Sweden
city: Malmo
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Uppsala
country: Sweden
Study officials:
affiliation: Uppsala University Hospital, Sweden
name: Lars Lannfelt, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lannfelt L, Blennow K, Zetterberg H, Batsman S, Ames D, Harrison J, Masters CL, Targum S, Bush AI, Murdoch R, Wilson J, Ritchie CW; PBT2-201-EURO study group. Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer's disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2008 Sep;7(9):779-86. doi: 10.1016/S1474-4422(08)70167-4. Epub 2008 Jul 30.
Clinical trial NCT00505128: Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis
Official title: Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Pancreatitis
Keywords: Biliary pancreatitis
Bile duct stones
EUS Endoscopic UltraSonography
Endoscopic sphincterotomy
ERCP
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-07-23
Enrollment: 900
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: Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.

Detailed description: Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.

Main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography.

Prospective multicenter randomized controlled study with direct patient benefit

Eligibility criteria: Inclusion Criteria:

* Previous medical examination
* Age over 18
* Acute biliary pancreatitis
* Timespan between onset of symptoms and randomization \<72h
* No involvement in another clinical study
* Informed consent obtained

Exclusion Criteria:

* Non biliary pancreatitis
* Age \< 18
* Timespan between onset of symptoms and randomization \>72h
* No follow-up possible beyond 3 months after inclusion
* Ongoing pregnancy
* No informed consent
* No health insurance affiliation
* Involvement in another clinical study
* Incapacity to understand subject information
* Counter indication of MRI examination if echo-endoscopy is not available

Primary outcomes:
measure: Percentage of patients cured or consolidated as a function of time
timeFrame: during 12 months
Secondary outcomes:
measure: overall morbidity
timeFrame: during the 36 months
measure: overall mortality
timeFrame: during the 36 months
measure: endoscopic procedure-related morbidity and mortality
timeFrame: during the 12months
measure: LOS
timeFrame: during the 12 months
measure: morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)
timeFrame: during the 12 months
measure: economic data
timeFrame: during the 36 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frederic PRAT, MD,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01013428: FLEX-Trial: Prospective Sonographic Assessment Of Healing Process Following Suture of Profound Flexor Tendon Due to Traumatic Rupture of FDP-Tendon in Zone II.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tendon Injury
Keywords: Traumatic Rupture of Tendon
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: To prospectively assess the healing process following suture of profound fexor tendon due to traumatic rupture of FDP-Tendon in Zone II by ultrasound.


Eligibility criteria: Inclusion criteria:

* All patients with traumatic rupture of FDP-tendon in zone II.

Exclusion criteria:

* \< 18years;
* Fracture;
* crush injury; (partial) amputation;
* RA;
* CPPD;
* CP;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References: