louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06975917: Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)
Official title: Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Biliary Tract Cancer
Biliary Tract Cancers (BTC)
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Turkish Oncology Group
First posted: 2025-05-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in any hospital (public, private, university/academic) across Türkiye

Brief summary: The goal of this observational study is to compare chemotherapy types that are given after surgery for biliary tract cancers. The main question it aims to answer is:

Are any of the chemotherapy regimens more effective in preventing recurrence, providing longer survival, or having less toxicity?

Nationwide multicenter retrospective data will be collected.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed biliary tract cancer (intrahepatic, perihilar, distal, gallbladder)
* Underwent curative-intent resection

Exclusion Criteria:

* Patients with a disease without histological confirmation
* Ampullary cancers

Primary outcomes:
measure: Recurrence-free survival
timeFrame: From the date of adjuvant chemotherapy initiation until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 180 months
measure: Overall survival
timeFrame: From the date of adjuvant chemotherapy initiation until the date of death from any cause, assessed up to 180 months
Secondary outcomes:
measure: 2-year recurrence-free survival
timeFrame: From start of adjuvant chemotherapy to the date of recurrence or death in the first 2 years
measure: 2-year overall survival
timeFrame: From start of adjuvant chemotherapy to the date of death in the first 2 years
measure: The number of patients experienced toxicities
timeFrame: From the date of initiation of the first cycle of adjuvant chemotherapy until 1 month after the last cycle of adjuvant chemotherapy
Other outcomes:
measure: Recurrence-free survival analyses in subgroups
timeFrame: From the date of adjuvant chemotherapy initiation until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 180 months
measure: Overall survival analyses in subgroups
timeFrame: From the date of adjuvant chemotherapy initiation until the date of death from any cause, assessed up to 180 months
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine Department of Medical Oncology
Study officials:
References:
Clinical trial NCT04257617: A Trial of ZL-1201 in Subjects With Advanced Cancer
Official title: First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Advanced solid tumors or hematologic malignancies
Lead sponsor: Zai Lab (Hong Kong), Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer

Detailed description: This is a first-in-human, dose escalation trial of ZL-1201. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Eligibility criteria: Inclusion Criteria:

* Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory or intolerant to standard of care therapy, or for which no standard therapy exists.
* Adequate hematologic status
* Adequate coagulation function
* Adequate hepatic function
* Adequate renal function

Exclusion Criteria:

* Known active brain metastases
* Red blood cells transfusion dependence
* Known cardiopulmonary disease
* Pregnant or breast-feeding females
* Any other serious underlying medical

Primary outcomes:
measure: Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events
timeFrame: From the time of informed consent to 30 days after last dose
Secondary outcomes:
measure: Pharmacokinetics：AUC
timeFrame: Up to 30 days after last dose
measure: Pharmacokinetics: Cmax
timeFrame: Up to 30 days after last dose
measure: Pharmacokinetics: t1/2
timeFrame: Up to 30 days after last dose
measure: Pharmacokinetics: CL
timeFrame: Up to 30 days after last dose
measure: Pharmacokinetics: Vss
timeFrame: Up to 30 days after last dose
measure: Immunogenicity
timeFrame: Up to 30 days after last dose
measure: Overall Response Rate (ORR）
timeFrame: Up to 2 years after enrollment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: US2004
state: Arizona
city: Jacksonville
country: United States
facility: US2005
state: Florida
city: Rochester
country: United States
facility: US2001
state: Minnesota
city: Saint Louis
country: United States
facility: US2003
state: Missouri
city: New York
country: United States
facility: US2002
state: New York
city: Chongqing
country: China
facility: CN1003
state: Chongqing
city: Hangzhou
country: China
facility: CN1002
state: Zhejiang
Study officials:
affiliation: Zai Laboratory
name: Study Physician
role: STUDY_DIRECTOR
References:
Clinical trial NCT03079817: Proprioception and Meditation
Official title: The Effects of Yoga Based Meditation on Proprioception in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Proprioceptive Disorders
Movement Disorders
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In past work is has been shown that yoga can be as effective as a standard balance or Tai Chi protocol; however, there is an inability to distinguish between the mind and body contributions of yoga training. This study will compare an accepted proprioceptive training program to a meditation program which concentrates on body awareness in individuals with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* An individual must be between 40 and 90 years of age with mild to moderate Parkinson's Disease (Hoehn \& Yahr stages I-III).

Exclusion Criteria:

* Participants that have been part of a formal training program that targeted lower body strength, balance or proprioception within the past six months
* Participants that have any uncontrolled nerve (except Parkinson's patients taking appropriate medication), bone or joint, or heart disease;
* Participants that have been advised by a doctor to not exercise;
* Participants that have regularly practiced yoga at least twice per week within the past six months;
* Participants that is unable to consent;
* Participants that is a prisoner;
* Participants that are pregnant.

Primary outcomes:
measure: Joint Position Sense
timeFrame: 20 minutes
measure: Tinetti balance and gait.
timeFrame: 3 minutes.
Secondary outcomes:
measure: 8ft Up and Go
timeFrame: 60 seconds
measure: Joint Kinesthesia
timeFrame: 20 minutes
measure: Dynamic Posturography
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Laboratory of Neruomuscular Research and Active Aging
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph F Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04772417: The Effects of Standardized vs Individualized Seat Height on 1-minute Sit-to-stand Performance
Official title: The Effects of Standardized vs Individualized Seat Height on 1-minute Sit-to-stand Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Individuals
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy individuals

Brief summary: The 1-minute sit-to-stand test (1MSTS) is a widely used functional capacity test and has promising predictive potential. Current standards of practice suggest the use of a chair with a standardized height. However, this practice makes the test more demanding for taller individuals than for shorter individuals. This implies over- or underestimation of functional capacity depending on body morphology.

Therefore, the aim of this study is to investigate the influence of knee joint angle, femur length and bodyweight on the 1MSTS performance in healthy subjects with different morphology.

Detailed description: This is a randomized cross-over trial with the participants performing both procedures twice in one visit. Sufficient breaks in between the tests is granted.

Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature
* Age 18 and older
* Healthy
* Ability to conduct a 1-minute sit-to-stand-test
* Ability to follow study procedures and instructions in German

Exclusion Criteria:

* Known cardiopulmonary or metabolic diseases (e.g., heart disease, diabetes mellitus etc.)
* Smoking (ex-smoker allowed; if they stopped smoking at least one year before the study inclusion)
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Respiratory infection in the last two weeks
* Pain during sit-to-stand movement

Primary outcomes:
measure: Repetitions in the 1-minute sit-to-stand test
timeFrame: Day 1
Secondary outcomes:
measure: Predictors towards performance in the 1-minute sit-to-stand test
timeFrame: Day 1
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT01184417: Phenobarbital for Acute Alcohol Withdrawal
Official title: Phenobarbital Versus Placebo for Acute Alcohol Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Withdrawal
Lead sponsor: Alameda County Medical Center
Sponsor class: OTHER
Collaborators: name: Alameda County Medical Center
First posted: 2010-08-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.


Eligibility criteria: Inclusion Criteria:

* Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria:

* allergy to phenobarbital, lorazepam, age\<18 or \>65

Primary outcomes:
measure: Number of Patients Requiring Continuous Lorazepam Infusion
timeFrame: 1 year
measure: Percentage of Patients Requiring ICU Admission
timeFrame: 1 year
measure: Total Lorazepam Required Per Patient Per Admission
timeFrame: 1 year
Secondary outcomes:
measure: Length of Stay
timeFrame: 1 year
measure: Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability
timeFrame: 1 year
measure: Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability
timeFrame: 1 year
measure: Number of Study Patients With Seizure as a Measure of Safety and Tolerability
timeFrame: 1 year
measure: Number of Study Patients With Mortality as a Measure of Safety and Tolerability
timeFrame: 1 year
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Alameda County Medical Center
state: California
Study officials:
References:
Clinical trial NCT02368717: An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-02-23
Enrollment: 281
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 the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed or recurrent mild to moderate left-sided active ulcerative colitis
* Mayo score of at least 4 but not greater than 10 points and a score of ≥ 2 for colonoscopy
* Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy
* The patient is compliant with Patient Daily Diary by having adequately responded to the questions on ≥5 of the most recent full 7 days before the Randomization Visit
* Negative stool test at screening to rule out parasites and bacterial pathogens

Exclusion Criteria:

* Patients receiving \> 2g/day of oral 5-aminosalicylic acid (5-ASA) products, or receiving topical rectal 5-ASA \> 3g/week, within 7 days prior to screening
* Severe/fulminant ulcerative colitis or toxic dilatation of the colon
* Prior bowel resection surgery
* Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates
* Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease
* Patients who are unable to fill in the Patient Daily Diary or follow data-capturing procedures

Primary outcomes:
measure: Clinical remission after 4 weeks treatment
timeFrame: At week 4
Secondary outcomes:
measure: Clinical response after 4 weeks treatment
timeFrame: At week 4
measure: Change in Quality of Life
timeFrame: From baseline to week 4
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 6th hospital affiliated to Zhongshan University (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT03281317: Vasoplegic Syndrome in Cardiac Surgery
Official title: Le Syndrome vasoplégique en Post-opératoire de Chirurgie Cardiaque: étude de Construction et de Validation d'un Score prédictif (Etude ISYVACC).
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vasoplegic Syndrome of Cardiac Surgery
Keywords: vasoplegicsyndrome
cardiac surgery
predictive risk score
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 1113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary bypass

Brief summary: Vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.This syndrome is characterized by persistent low blood pressure despite an optimization of preload and inotropism.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing cardiac surgery with extracorporeal circulation
* Patients covered by a social insurance system.
* Patients who have given oral consent to participate after full information

Exclusion Criteria:

* Cardiac graft.
* Preoperative ECMO / ECLS.
* Cardiac assistance.
* Minor,
* Patient deprived of liberty, or under safeguard of justice.

Primary outcomes:
measure: Vasoplegic syndrome
timeFrame: 30 days
Secondary outcomes:
measure: Post operative organ failure
timeFrame: 30 days
measure: Arrythmia
timeFrame: 30 days
measure: Inotropic use
timeFrame: 30 days
measure: cardiac damage
timeFrame: 1 day
measure: Post operative Sepsis
timeFrame: 30 days
measure: Hemorrhage
timeFrame: 30 days
measure: Blood transfusion
timeFrame: 30 days
measure: ICU stays
timeFrame: 30 days
measure: Hospital stays
timeFrame: 30 days
measure: Death
timeFrame: one year
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
affiliation: guinot.pierregregoire@chu-amiens.fr
name: Pierre Grégoire guinot.pierregregoire@chu-amiens.fr, Doctor
role: STUDY_DIRECTOR
affiliation: CHU STRASBOURG
name: Paul Michel MERTES, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Jean-Luc Simon Jean-Baptiste FELLAHI, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: FISCHER Marc Olivier, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU DIJON
name: GIRARD Claude, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP, Paris
name: Longrois Dan, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: BESNIE Emmanuel, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02836717: Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
Official title: Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Fecal Incontinence
Keywords: sacral nerve modulation
quality of life
stimulator maintenance
SNM
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients starting an SNM treatment for constipation or fecal incontinence between March 2006 and October 2015

Brief summary: The aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (SNM) treatment for constipation or stool incontinence.


Eligibility criteria: Inclusion Criteria:

* Patients who had received an SNM treatment in the last 10 years

Exclusion Criteria:

* pudendal nerve stimulation
* refusal to allow use of clinical data for retrospective data analysis

Primary outcomes:
measure: Percentage of Patients Considering the Treatment a Success After 5 Years
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of Patients Considering the Treatment a Success After 1 Years
timeFrame: 1 year
measure: Percentage of Patients Considering the Treatment a Success After 3 Years
timeFrame: 3 year
measure: Number of Patients at Risk After 1 Year
timeFrame: 1 year
measure: Number of Patients at Risk After 3 Years
timeFrame: 3 year
measure: Number of Patients at Risk After 5 Years
timeFrame: 5 year
measure: Rate of Permanent Stimulator Implantations
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Lukas Marti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Widmann B, Galata C, Warschkow R, Beutner U, Ogredici O, Hetzer FH, Schmied BM, Post S, Marti L. Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study. J Neurogastroenterol Motil. 2019 Jan 31;25(1):159-170. doi: 10.5056/jnm17106.
Clinical trial NCT02310217: Validation of New Tools for the Assessment of Cognitive Functions and Connectivity Network in Hypertensive Patients
Official title: Validation of New Tools for the Assessment of Cognitive Functions and Connectivity Network in Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Cognitive Impairment
Keywords: Hypertension
Cognitive impairment
Biomarkers
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected from the Department of Angiocardioneurology and Translational Medicine of the IRCCS Neuromed, according to specific inclusion criteria. Approximatey 80 subjects per group, aged between 40 and 65 years, will be included in the study.

Brief summary: The relationship among hypertension, aging and cognitive decline is complex and not completely understood. Purpose of this project will be evaluating early markers of cognitive deterioration in patients with arterial hypertension. In particular, this cross-sectional observational study will be articulated in three phases:

1. Neuropsychological evaluation of general cognitive abilities
2. Identification and measurement of specific biomarker levels
3. Correlation among hypertension, cognitive abilities and biomarkers.


Eligibility criteria: Inclusion Criteria:

* Males or females diagnosed with arterial hypertension between 40 and 65 years of age;
* Written informed consent prior to enrollment in the study.

Exclusion Criteria:

* Precedent acute myocardial infarction (AMI);
* Previous stroke and/or transient ischemic attack (TIA);
* Previous or concomitant neurologic or psychiatric pathologies;
* Neurologic or psychiatric pharmacological therapy.

Primary outcomes:
measure: Cognitive abilities measured by validated neuropsychological test battery (Montreal Cognitive Assessment test, Verbal Fluency test,learning of couple words, Stroop test)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
state: (is)
Study officials:
References:
citation: Carnevale L, Maffei A, Landolfi A, Grillea G, Carnevale D, Lembo G. Brain Functional Magnetic Resonance Imaging Highlights Altered Connections and Functional Networks in Patients With Hypertension. Hypertension. 2020 Nov;76(5):1480-1490. doi: 10.1161/HYPERTENSIONAHA.120.15296. Epub 2020 Sep 21.