louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02103179: VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway (ECC)
Official title: VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extrahepatic Cholangiocarcinoma
Keywords: Extrahepatic cholangiocarcinoma
ECC
VEGF signaling
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Province, Department of Science and Technology
First posted: 2014-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extrahepatic cholangiocarcinoma patients underwent surgical therapy

Brief summary: The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis.

Detailed description: Several studies have documented the elevated expression of VEGF, VEGFR1 and VEGFR2 in cancer cell lines. Another study observed a sequential elevation of VEGF in low-grade dysplasia, high-grade dysplasia and early stage liver cancer. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in ECC cells and its possible mechanism in regulating ECC growth.Therefore,we try to clarify the mechanism of VEGF signal in ECC growth,proliferation and apoptosis.

Eligibility criteria: Inclusion Criteria:

1. Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma
2. Child-Pugh A or B
3. well preserved renal and hematopoietic Function
4. receive surgical therapy
5. achieve complete section accessed by contrast-enhanced CT

Exclusion Criteria:

1. incomplete section
2. remote metastasis
3. Child-Pugh C
4. combination with other hepatobiliary disease
5. suffer from other tumors concurrently or in last five years

Primary outcomes:
measure: the variation of the quantity of VEGF signal pathway genes in normal liver tissue,peri tumor,tumor and metastasis.
timeFrame: the day when conducting surgery (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ming Kuang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06114979: Silodosin vs Placebo in the Treatment of Female LUTS
Official title: Silodosin vs Placebo in the Treatment of Female Lower Urinary Tract Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Lower Urinary Tract Symptoms
Keywords: Silodosin
LUTS
Female
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Amiri Hospital
First posted: 2023-11-02
Enrollment: 278
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms.

Detailed description: The double blinded randomized controlled trial will evaluate efficacy and safety of silodosin in treatment of female lower urinary tract symptoms by comparing with placebo.

Eligibility criteria: Inclusion Criteria:

* Females complaining of lower urinary tract symptoms
* IPSS ≥ 8 or OAB - V8 score ≥ 8

Exclusion Criteria:

1. Patients with documented hypersensitivity to Silodosin.
2. Patients receiving alpha blockers or anticholinergic medications for any other reason.
3. Patients with history of orthostatic hypotension.
4. Pregnant or breastfeeding females.
5. Patients with stress urinary incontinence.
6. Patients with active urinary tract infection.
7. History of previous pelvic surgery or radiation.
8. Patient with diabetes mellitus.
9. Patients diagnosed with bladder cancer.
10. Patients with hepatic impairment (Child-Pugh score \>9).
11. Patients with severe renal impairment with creatinine clearance of less than 10 mL/min.
12. Patients planned to undergo any ophthalmic procedure.
13. Patients with history of urinary retention or gastric retention.

Primary outcomes:
measure: International Prostate Symptom Score
timeFrame: 8 weeks
measure: Overactive Bladder Validated 8-question
timeFrame: 8 weeks
Secondary outcomes:
measure: Uroflometry
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amiri Hospital
name: Tariq F AL-Shaiji, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04020679: The Goals of Care Initiative
Official title: A Hybrid Implementation-effectiveness Stepped Wedge Cluster Randomised Controlled Trial to Determine the Effectiveness of the Goals of Care Initiative
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Decision-Making Oncology
Chemotherapy Effect
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2019-07-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Cluster Randomised Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: A single site hybrid implement-evaluation stepped wedge cluster randomised controlled trial in which cancer cluster groups (lung, colorectal, breast, renal, ovarian, upper GI \& sarcoma) are randomised sequentially to initiate the Goals of Care Initiative into clinical practice.


Eligibility criteria: Inclusion Criteria:

* Undergoing, or being considered for, systemic treatment from one of the cluster teams.
* 18+ years.
* Able to give written consent.
* Able to understand verbal and written English.

Exclusion Criteria:

• Patient is not being considered for Systemic Anti-Cancer Treatment.

Primary outcomes:
measure: SDM-Q-9
timeFrame: Immediately following intervention
measure: Decision Conflict Scale
timeFrame: Immediately following intervention
Secondary outcomes:
measure: Decision Self Efficacy Scale
timeFrame: Immediately following intervention, then at 6 weeks and 12 weeks.
measure: EQ-5D-5L
timeFrame: Immediately following intervention, then at 6 weeks and 12 weeks.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: Janelle Yorke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00648479: New Method for Distal Interlocking of Cannulated Intramedullary Nails
Official title: New Method for Distal Interlocking of Cannulated Intramedullary Nails
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Fracture
Keywords: Fracture Fixation
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-04-01
Enrollment: 10
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: DIAGNOSTIC

Brief summary: We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study.

Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes) using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the same operation using the new navigation system:"The Guiding star" method.

The allocation will be random.


Eligibility criteria: Inclusion Criteria:

1. Signing Informed consent.
2. Conscious patients.

Exclusion Criteria:

1. Hemodynamic Instability.
2. Multiple system injuries.
3. Pregnancy.
4. Soldiers.

Primary outcomes:
measure: the outcome will be asses using regular fluoroscopy in the operation room.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04678479: Ganaxolone Expanded Access Program Compassionate Use
Official title: Expanded Access With Adjunctive Ganaxolone Treatment in Children and Young Adults With Cyclin Dependent Kinase-like 5 Deficiency Disorder
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: CDKL5 Disorder
Lead sponsor: Marinus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-12-22
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The primary objective is to provide GNX to patients ≥ 2 years with CDD-related seizures who are refractory to, or intolerant of, standard therapy.

Detailed description: This is a multi-center, long-term, open-label, expanded access protocol of adjunctive GNX treatment in children, adolescents, and adults with CDD. Patients with inadequate seizure control on their current anti seizure medications at therapeutic doses will be eligible for enrollment.

Eligibility criteria: Inclusion Criteria:

* Molecular confirmation of a pathogenic CDKL5 variant, early onset, difficult to control seizures, and neurodevelopmental impairment are required. Male or female patients aged ≥ 2 years. In the opinion of the investigator, the patient has inadequate seizure control on current anti-seizure medications at therapeutic doses.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Marinus Pharmaceuticals, Inc.
name: Paula Bokesch, MD, FAAP
role: STUDY_DIRECTOR
affiliation: Marinus Pharmaceuticals, Inc.
name: Igor Grachev, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03267979: Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study
Official title: Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Keywords: pain assessment
pupillary diameter
variation coefficient of pupillary diameter
pain self assessment
video-pupillometer
electrocardiogram
analgesic treatment
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 345
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: Different pain assessment methods have been proposed to evaluate analgesic efficacy after surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment. But, cooperation of the patient is limited by cultural differences, language barriers or residual effect of products used while general anesthesia.

A lot of study were conducted to demonstrate and to quantify the pain after an operation. The aim will be dose analgesic treatment better without cooperation of the patient.

This sudy concerns patients on the post anesthesia care units one hour after their arrival. They will have electrocardiogram and video-pupillometer.

Detailed description: Primary objective is to compare Variation Coefficient of Pupillary Diameter (VCPD) obtained during a light flash and pain assessment realized thanks to Visual Analog Scale (VAS). Too, Variation Coefficient of Pupillary Diameter (VCPD) with electrocardiogram will be measured to demonstrate a correlation between the three parameters.

Eligibility criteria: Inclusion Criteria:

* Major patients
* Patients fluent in French
* Patient admitted on the post anesthesia care units

Exclusion criteria:

* Patients operated for all types of surgery except for heart, intra-cerebral, and ophthalmologic surgeries
* Emergency operation
* Heart rhythm disorders
* Pacemaker

Primary outcomes:
measure: Correlation between pupillary diameter (PD) and pain assessment
timeFrame: 1 hour post surgery
Secondary outcomes:
measure: Correlation between pupillary diameter (PD) and heart rate
timeFrame: 1 hour post surgery
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David CHARIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charier D, Vogler MC, Zantour D, Pichot V, Martins-Baltar A, Courbon M, Roche F, Vassal F, Molliex S. Assessing pain in the postoperative period: Analgesia Nociception IndexTMversus pupillometry. Br J Anaesth. 2019 Aug;123(2):e322-e327. doi: 10.1016/j.bja.2018.09.031. Epub 2019 Jan 26.
Clinical trial NCT01346579: Biomarkers in Tissue Samples From Older Women With Breast Cancer
Official title: PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: stage IA breast cancer
stage IB breast cancer
estrogen receptor-positive breast cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-03
Enrollment: 505
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer enrolled on Cancer and Leukemia Group B 9343

Brief summary: This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:

To assess the relapse free-survival difference between patients with PIK3CA mutated and wild-type (WT) tumors and therefore validate PIK3CA mutation status as an important biomarker in women 70 years or older diagnosed with breast cancer.

OUTLINE:

Previously collected tissue samples are analyzed via mutation analysis of PIK3CA.

Eligibility criteria: * Participants with stage I breast cancer (T1N0M0) and estrogen-receptor status positive or unknown
* Patients underwent lumpectomy with negative margins and were clinically node-negative

Primary outcomes:
measure: Breast cancer-free interval for patients with PIK3CA-mutated tumors
timeFrame: baseline
measure: Tumor size
timeFrame: baseline
measure: Estrogen receptor status
timeFrame: baseline
measure: Lymph node status
timeFrame: baseline
measure: Treatment group associated with PIK3CA expression
timeFrame: baseline
Secondary outcomes:
measure: Overall survival associated with PIK3CA
timeFrame: baseline
measure: Breast cancer specific survival associated with PIK3CA expression
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mary Ellen Moynahan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05657379: Effect of Moisturizer on Malaysian Women Facial Skin
Official title: The Effect of Product X Moisturizer on Skin Texture of Middle-Aged Women in Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Middle-aged women, moisturizer
Lead sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 28
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate the effect of Product X on facial skin of middle-aged women in Malaysia. The main questions it aims to answer are:

1. The effect of Product X on skin hydration of middle-aged women in Malaysia.
2. The effect of Product X on skin elasticity of middle-aged women in Malaysia.
3. The effect of Product X on skin wrinkle of middle-aged women in Malaysia.
4. To observe any adverse effect occurrence with the use of Product X.

Participants will used Product X for 8 week and the skin assessment will be carried out at baseline, week 2, 4 and week 8.


Eligibility criteria: Inclusion Criteria:

* Malaysian citizen
* Middle-aged woman (40-60 years old)

Exclusion Criteria:

* Participants taking isotretinoin
* Immunocompromised patients or participants with any skin diseases or diseases that may compromised the participants well-being and study outcome.
* Participant who undergo any cosmetic procedures such as laser \& light treatment for the past three months.
* Participant with a history of facial surgery.

Primary outcomes:
measure: Change in skin hydration from baseline and at week 2, 4 and 8 after using Product X
timeFrame: Baseline, week 2, 4 and 8
measure: Change in skin elasticity from baseline and at week 2, 4 and 8 after using Product X
timeFrame: Baseline, week 2, 4 and 8
measure: Change in skin wrinkles from baseline and at week 2, 4 and 8 after using Product X
timeFrame: Baseline, week 2, 4 and 8
measure: Adverse effect after using Product X
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
state: Selangor
Study officials:
References:
Clinical trial NCT01862484: Neuroimaging of Diet in ADHD: Phase I
Official title: Neuroimaging of Diet and Medication in the Treatment of ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Diet
Functional Magnetic Resonance Imaging
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be placed on a restriction diet for a 5 week period. Children will be randomized to either receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a double blind fashion. It is hypothesized that children who are consistently on the restricted diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.

Detailed description: The ADHD rating scale (RS) will be the principal behavioral outcome measure. We hypothesize that children on restriction diet will have significantly lower ADHD RS scores after 5 weeks relative to the Ruse diet group. In addition children will undergo functional magnetic resonance imaging (fMRI) at baseline and again at 5 weeks. Children will perform a flanker task known to engage the dorsolateral prefrontal cortex (DLPFC) and the anterior cingulate cortex (ACC) during attention tasks. The children will also perform will look at pictures of appealing and unappealing food and rate whether they would like to eat it or not. This task is known to activate the ventral striatum (VS) (reward processing). A secondary hypothesis is whether children on the restricted diet will show changes in activity and connectivity of areas (DLPFC, ACC, VS) relative to those on the Ruse diet.

Eligibility criteria: Inclusion Criteria:

* Age 9-12 years
* Meets criteria for Attention Deficit Hyperactivity Disorder
* Parent must agree to use Study Diet Manual

Exclusion Criteria:

* Any Axis I psychiatric disorder other than Oppositional Defiant Disorder or Anxiety Disorder not requiring psychopharmacological management
* Not currently on any pharmacological agent other than medication for ADHD

Primary outcomes:
measure: ADHD Rating Scale IV
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Stevn R Pliszka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03304184: The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
Official title: The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Quality of Life
Cervical Abrasion
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will be treated with a tooth colored filling that will be placed near the gum line. The second group will be treated with a white colored filling that will be placed near the gum line.
Primary purpose: TREATMENT

Brief summary: The study will compare two different dental materials on dental lesions near the gum line that cause chronic pain on oral health related quality of life.

Detailed description: The study will compare two different dental materials on dental lesions near the gum line. One of the materials is tooth colored and the other material is white but both materials use different mechanisms to attach to the teeth and may have different outcomes. The study will determine if one material is more effective in relieving chronic pain. In addition, we will evaluate changes in oral health related quality of life after the placement of the two different dental materials.

Eligibility criteria: Inclusion Criteria:

* Males and females age 18-64
* Chief complaint associated with pain from cold or hot
* Chronic sensitivity associated with supragingival lesions
* Pain not associated with decay
* Fluent in English and able to read English at a 6th grade level
* Pulpal response \<40 via pulp tester
* Active salivary flow from palpation of parotid and submandibular glands
* Patients self reporting pain over 6/10 in the past week and/or the past 2 months

Exclusion Criteria:

* Pregnant women
* Patients taking benzodiazepines, narcotics and multiple antidepressants for pain management not associated with the oral cavity
* Unexplained dry mouth
* Patients taking two or more medications associated with dry mouth
* Pulpal response \>40 via pulp tester
* Patients requiring treatment for more than 5 decayed sites, periodontal disease and root canal therapy
* Complicated medical history (\>4 concurrent treatment for systemic diseases)
* Lesion \>1mm below the gum line

Primary outcomes:
measure: Global Base Changes of Pain
timeFrame: baseline, week1, week 2, 3 month follow up
measure: Oral Health Related Quality of Life Using a Survey With 49 Questions
timeFrame: Baseline, week1, week 2, 3 month follow up
measure: Brief Pain Inventory
timeFrame: Baseline, week1, week 2, 3 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Dental School
state: Michigan
Study officials:
References: