louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06156748: CT Imaging for Guiding PA-TACE for HCC
Official title: CT Imaging for Guiding Postoperative Adjuvant Transarterial Chemoembolization for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Hepatocellular
Keywords: Carcinoma, Hepatocellular
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 1488
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included 1,488 patients (median age, 52 years \[IQR, 45-61 years\]; 1,309 male).

Brief summary: Postoperative adjuvant transarterial chemoembolization (PA-TACE) may improve survival outcomes in a subset of patients with resected hepatocellular carcinoma (HCC), reliable biomarkers for the criterion for the selection of candidates are lacking. The present study aimed to evaluate whether CT imaging can provide more value for predicting benefit from PA-TACE.


Eligibility criteria: Inclusion Criteria:

* CT scans acquired no more than one month before surgery
* Confirmation of HCC diagnosis by pathological examination
* Curative surgical resection

Exclusion Criteria:

* Prior antitumor treatment
* Macrovascular thrombosis or metastasis
* Perioperative mortality
* Unqualified image artifacts
* Tumor rupture
* MVI status not reported

Primary outcomes:
measure: Overall survival
timeFrame: the date of hepatectomy to the last follow-up or until death, whichever came first, assessed up to 120 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT05428748: Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers
Official title: An Open-label, Parallel and Randomized Trial to Assess the Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerance
Lead sponsor: Liquid I.V.
Sponsor class: OTHER
Collaborators: name: University of Memphis
First posted: 2022-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals who are between 18 - 35 years of age. Have a body mass index (BMI) range of 18.0 - 24.9 kg/m2. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures

Exclusion Criteria:

* Participant has a positive medical history of heart disease/cardiovascular disease, uncontrolled hypertension (140/90 or greater mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type I or Type II diabetes. Participant has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea). Individuals who are lactating, pregnant or planning to become pregnant during the study. Have a known sensitivity or allergy to any of the study products. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data. History of alcohol or substance abuse in the 12 months prior to screening. Receipt or use of an investigational product in another research study within 28 days prior to baseline/Visit 2

Primary outcomes:
measure: Safety of test product
timeFrame: 28 days
measure: Tolerability of test product
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The University of Memphis
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00786448: Post Marketing Surveillance Study on Emselex After Launch in Germany
Official title: Post-Marketing Surveillance Study Emselex
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-11-06
Enrollment: 5821
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from routine practice

Brief summary: - Data are obtained of Emselex in routine treatment of Overactive Bladder. The general objectives are to evaluate the product safety, compatibility, efficacy and patient acceptance.


Eligibility criteria: Inclusion Criteria:

* Patients who are treated with Emselex for Overactive Bladder

Exclusion Criteria:

* Exclusion criteria are the contraindications as specified in the German product information

Primary outcomes:
measure: Adverse events, Adverse drug reactions, physician's global assessment of tolerability
timeFrame: After 2-3 months of treatment (long-term 6 months)
Secondary outcomes:
measure: Incontinence
timeFrame: At end of study
measure: Urgency episodes
timeFrame: At end of study
measure: Micturitions / nycturitions
timeFrame: At end of study
measure: Physician's assessment of improvement/efficacy
timeFrame: At end of study
measure: Physician's assessment of patient's satisfaction with therapeutic effect
timeFrame: At end of study
measure: Physician's assessment of patient's ability to hold urine
timeFrame: At end of study
measure: Dose and treatment duration of Emselex
timeFrame: At end of study
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02278848: Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus
Official title: Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Adult Hydrocephalus
Keywords: Computerised gait analysis
Ultrasound measurement of cerebral pulsatility
MRI flow
Urinary incontinence scale
Subtractive lumbar puncture
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 39
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled cavities in the brain. The clinical symptoms are gait disturbance, mental decline and incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be able to induce regression of the symptoms in many cases meaning that ICAH is a classic, curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is complicated: improvement is often incomplete and there is no consensus on either how to assess the symptoms or how they change after CSF depletion. In consequence, the decision whether not to undertake surgery often depends on the neurosurgeon's clinical impression.

Over recent years, the cognitive profile of patients with ICAH has become better characterised and reproducible, objective techniques have been developed to assess motor function and CSF flow in the brain.

The investigators project aims to define the value of these new investigative techniques in the positive diagnosis of ICAH, in comparison to current decision-making tools.


Eligibility criteria: Inclusion Criteria:

* Adult 65 years or older
* Hospitalized patients (at the University Hospital of Tours) requiring the assessment of chronic hydrocephalus in adults, suspected clinically
* Patient undergoing Lumbar Puncture subtractive
* Informed consent form signed
* Affiliated to a medical insurance

Exclusion Criteria:

* Contraindications to MRI
* Inability to walk or to stand before having lumbar puncture
* Patient under trusteeship and guardianship, or judicial protection

Primary outcomes:
measure: Cerebrospinal fluid biomarkers of degeneration from Alzheimer's disease.
timeFrame: 5 days
measure: Computerised gait analysis
timeFrame: 5 days
measure: Ultrasound measurement of cerebral pulsatility
timeFrame: 5 days
measure: Qualitative and quantitative analysis (average speed and flow) of the hydrodynamic characteristics of the cerebrospinal fluid.
timeFrame: 5 days
measure: Urinary incontinence
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: CHRU de Tours
name: Karl MONDON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00496548: Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
Official title: Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2007-07-04
Enrollment: 159
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 purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.

Detailed description: The available clinical measures of Crohn's disease activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing inflammatory bowel disease (IBD) disease activity including erythrocyte sedimentation rate, C-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. What is needed is a simple, non-invasive, biologic measure of Crohn's disease.

Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls.

Eligibility criteria: Inclusion Criteria:

* Outpatient male or female 18 years or older
* Confirmed diagnosis of Crohn's disease
* Informed consent obtained
* Able to give blood, urine and stool samples
* Willing to undergo a diagnostic colonoscopy as part of routine Crohn's disease care

Exclusion Criteria:

* Unable to give consent
* Ulcerative colitis
* Does not meet inclusion criteria
* Pregnant

Primary outcomes:
measure: Urine for PGE-M levels
timeFrame: Day of colonoscopy procedure
Secondary outcomes:
measure: Blood for C-reactive protein (CRP) levels
timeFrame: Day 1
measure: Stool for fecal calprotectin
timeFrame: Prior to colonoscopy procedure (before beginning bowel prep)
measure: Routine colonoscopy for assessment of disease activity
timeFrame: 1-3 weeks from consent
measure: Harvey-Bradshaw index disease activity score
timeFrame: Day of colonoscopy procedure
Other outcomes:
Locations:
city: Nashville
country: United States
facility: GI Clinical Research; Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: David A. Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05926648: Form, Fit, and Function of INVSENSOR00061
Official title: Form, Fit, and Function of INVSENSOR00061
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 53
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the form, fit, and function of INVSENSOR00061 when used on newborn and infant subjects 0-18 months.


Eligibility criteria: Inclusion Criteria:

* Subject is a full-term newborn (37 weeks) - up to 18 months of age.
* The parent(s) or guardian(s) of minor subjects are able to read and communicate in English and understand the study and the risks involved.

Exclusion Criteria:

* Subject has underdeveloped skin.
* Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
* Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Primary outcomes:
measure: INVSENSOR00061 SpO2 Accuracy
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT02202148: Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Withdrawal
Keywords: Fibroscan
alcohol dependence
alcohol withdrawal
controlled attenuation parameter
BDNF
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
Collaborators: name: Hôpital Dupuytren
First posted: 2014-07-28
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: alcohol-dependent subjects hospitalized for alcohol withdrawal

Brief summary: This study is complementary to the main study "Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal " NCT01491347.

Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption. It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to depend on alcohol consumption in alcohol dependent patient, more precisely on the time after the last alcohol consumption. This is very few documented after alcohol withdrawal, and has never been explored during several months after withdrawal as a function of alcohol consumption and abstinence.

Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis and also liver function.

We propose here to analyse the serum BDNF levels variations after withdrawal according to liver stiffness levels and alcohol consumption status.

We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14, 28 and months 2, 4, and 6.


Eligibility criteria: Inclusion Criteria:

* participation to the study "BDNF serum levels evolution during 6 months after alcohol withdrawal" (main study)
* criteria from the main study

Exclusion Criteria:

* criteria from the main study

Primary outcomes:
measure: BDNF serum levels as a function of stiffness categories in the abstinent and non abstinent groups at inclusion and at the different follow-ups of the study (M2, M4, M6)
timeFrame: 6 months maximum
Secondary outcomes:
measure: serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.
timeFrame: 6 months
measure: liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6
timeFrame: 6 months
measure: Variations in liver stiffness
timeFrame: 6 months
measure: controlled attenuation parameter (CAP) at each follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
Study officials:
affiliation: Centre Hospitalier Esquirol
name: Philippe Nubukpo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02703948: Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Augmentation and Correction of Perioral Rhytids
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .


Eligibility criteria: Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing written informed consent including release of copyright of photography images.
* Males or females, 22 years of age or older
* Subjects seeking augmentation therapy for the lips.

Exclusion Criteria:

* History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
* History of allergy or hypersensitivity to lidocaine, other amide type anesthetics, or topical anesthetics or nerve blocking agents
* Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.

Primary outcomes:
measure: Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: United States, California
state: California
city: San Diego
country: United States
facility: United States, California
state: California
city: Miami
country: United States
facility: United States, Florida
state: Florida
city: Roswell
country: United States
facility: United States, Georgia
state: Georgia
Study officials:
References:
Clinical trial NCT01764048: To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Cesarean Section
Keywords: pain management
cesarean section
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request).

The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses).

The protocols will be used for the first 48 hours following surgery.


Eligibility criteria: Inclusion Criteria:

* women that underwent cesarean section

Exclusion Criteria:

* Women suffering from chronic pain
* Women using chronic pain medications
* Allergy to any drug used in the study
* Women underwent general anesthesia during the surgery
* women with elevated liver enzymes

Primary outcomes:
measure: The efficacy of pain management
timeFrame: during 48 hours from surgery
Secondary outcomes:
measure: adverse effect of the medications given in each protocol
timeFrame: during 48 hours following surgery
measure: to compare the amount of breastfeeding between 2 groups
timeFrame: following the week after surgery
measure: The number of times that pain medications were given in each study group
timeFrame: during 48 hours following surgery
measure: The necessity of additional medications (rescue doses)
timeFrame: During 48 hours after surgery
measure: Patient satisfaction
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Departement of obstetric and gynecology, HaEmek medical center
Study officials:
References: