louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05603312: A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
Official title: A Randomized, Double-Blind, Sham-Controlled Study to Evaluate the Safety and Tolerability of Glutamic Acid Decarboxylase Gene Transfer to the Subthalamic Nuclei in Participants With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson Disease
Lead sponsor: MeiraGTx UK II Ltd
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are enrolled in one of three groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to evaluate the safety and tolerability of adeno-associated virus (AAV)-mediated delivery of glutamic acid decarboxylase (GAD) gene transfer into the subthalamic nuclei (STN) of participants with Parkinson's Disease.

Detailed description: The planned length of participation in the study for each participant will be approximately 7 months. This includes a screening period of up to 40 days, randomization and surgery, and a follow-up period of 26 weeks.

Eligibility criteria: Inclusion Criteria:

* Confirmed Parkinson's Disease
* Levodopa responsiveness for at least 12 months
* UPDRS Part 3 score of ≥25 points in the "off" state

Exclusion Criteria:

* Past history of brain surgery to treat Parkinson's Disease
* Any history of cerebral insult or central nervous system infection
* Atypical Parkinson's Disease
* Focal or lateralized neurologic deficits
* Evidence of significant medical or psychiatric disorders
* Cognitive impairment as defined by Montreal Cognitive Assessment (MoCA)≤20
* Beck Depression Inventory-II score of ≥ 20

Primary outcomes:
measure: Safety and tolerability of AAV-GAD delivered to the STN in patients with Parkinson's Disease
timeFrame: Baseline to Week 26
Secondary outcomes:
Other outcomes:
measure: The effect of AAV-GAD on the Unified Parkinson's Disease Study Rating Scale (MDS-UPDRS) Part 3 (motor function) score in the "off medication state"
timeFrame: Baseline to Week 26
Locations:
city: New Haven
country: United States
facility: Yale University - Yale New Haven Hospital
state: Connecticut
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References:
Clinical trial NCT02307812: Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France
Official title: Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-12-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the ATU.


Eligibility criteria: Inclusion Criteria:

* The participant has histologically or cytologically confirmed gastric adenocarcinoma, including gastroesophageal junction (GEJ) adenocarcinoma (Participants with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ.) after prior chemotherapy.
* Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5-fluorouracil (5-FU) and capecitabine). Prior trastuzumab use in human epidermal growth factor receptor 2 positive (HER2+) participants is accepted too.
* The participant is eligible for treatment by chemotherapy and has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

Exclusion Criteria:

* Participant has a known allergy to any of the treatment components.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02492412: Efficacy and Safety of HE10 for Dry Eye Syndrome
Official title: Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-08
Enrollment: 101
Sex: ALL
Minimum age (years): 21
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 evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.

Detailed description: This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.

Eligibility criteria: Inclusion Criteria:

* Corneal staining score of ≥2(Oxford grade)
* Schirmer test score (without anesthesia) \< 10 mm/5 min in either eye
* Tear break-up time is 10 seconds or less
* Screening both eyes, the corrected visual acuity is 0.2 or more

Exclusion Criteria:

* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* The patients with systemic or ocular disorders affected the test result
* Being treated with systemic steroid
* History of eyeball surgical operation within 3 months of screening visit
* Wearing contact lenses within 2 weeks of screening visit
* Be a use or used punctual plug within 1 month of screening vist
* Use of cyclosporine eye drop within 3 weeks
* Pregnancy or Breastfeeding
* Intraocular pressure \> 25 mmHg
* Abnormal eyelid function : Disorders of the eyelids or eyelashes

Primary outcomes:
measure: Corneal staining Test to assess eye dryness
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03852212: Ninth Dorsal Osteopathic Visceral Manipulation D9
Official title: Ninth Dorsal Osteopathic Visceral Manipulation D9 Affects Pancreas Blood Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopathia
Manipulation
Keywords: Thrust technique
Blood levels
Pancreas
Ninth vertebra
Manipulation
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study is to verify that the vertebral manipulation of dorsal level D9 influences the pancreas biochemical and endocrinology blood values.

Detailed description: A longitudinal experimental study was conducted in which the osteopathic thrust maneuver was applied. In this research, 87 healthy subjects participated, of which 56.3% (n = 49) are men and 43.7% (n = 38) are women aged 19-29 who study at the Catholic University of Murcia.The blood analytical values of insulin and glycemia have been measured in 4 different times: at baseline, after 2,5 and 10 minutes of the technique application with the purpose to verify any possible change.

Eligibility criteria: Inclusion Criteria:

* students between 18-27 years old
* healthy persons
* Acceptance of informed consent

Exclusion Criteria:

* pancreatitis
* diabetes I,II type
* anemia
* Alcohol intake for 12 hours prior.

Primary outcomes:
measure: Basal insulin laboratory value change
timeFrame: 10 minutes
measure: Basal glycemia laboratory value change
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03961412: A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
Official title: Evaluation of A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cervical Cancer
Healthy Women
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 224
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to find out the impact of the involvement of an influential person(s) (e.g., spouse, partners, parents, children, friends) on Pap test screening intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap test screening among Chinese American immigrant women. These data specific to the impact of the involvement of an influential person on Pap test screening could be used to develop successful cancer prevention programs that target the specific needs of Chinese populations.

Detailed description: The importance of the support from family, spouse, friends, or significant others has been noted among Chinese American immigrant women (CAIW), but little attention has been paid to the effects of family-based (FB) interventions, especially for cervical cancer screening. Understanding the role of CAIW's family in promoting Pap screening and other influences can lead to the creation of more culturally appropriate screening interventions. The objective of this study is to test the effects of a FB intervention on Pap test intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap tests among under-screened CAIW aged 21-65. This pilot test of the FB intervention will be conducted using a randomized controlled design with two groups only, experimental and control groups. Interventions will be delivered by bilingual and bicultural CAIW trained facilitators. Post-test and follow-up telephone surveys will be conducted at 2 weeks and 6 months after the intervention.

Eligibility criteria: Inclusion Criteria:

* a first-generation Chinese American
* no previous cervical cancer screening within the past 3 years
* no total hysterectomy
* no history of cervical cancer
* able to read English, Simple Chinese, or Traditional Chinese.

Exclusion Criteria:

* Not a Chinese American immigrant
* Had total hysterectomy
* Had history of cervical cancer
* Not able to read English or Chinese

Primary outcomes:
measure: Change in Receiving a Pap Test
timeFrame: 2 weeks after intervention
measure: Change in Receiving a Pap Test
timeFrame: 6 months after intervention
measure: Change in Intention to Receive a Pap Test
timeFrame: 2 weeks after intervention
measure: Change in Intention to Receive a Pap Test
timeFrame: 6 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03892512: Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction
Official title: The Effect of Dexmedetomidine and Esmolol on Early Post Operative Cognitive Dysfunction After Middle Ear Surgery Under Hypotensive Technique :Comparative , Randomized Double Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cognitive Dysfunction
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Dexmedetomidine is a highly selective α2adrenoceptor agonist recently introduced to anesthesia that produces dose dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites) without respiratory depression.

From a pharmacokinetic perspective,dexmedetomidine has a half life of nearly 2 hours, duration of action of nearly 4 hour, and thus, a side effect profile that is shorter in duration than clonidine.

Esmolol is a cardioselective beta₁ receptor blocker with rapid onset, a very short duration of action (elimination half-life is approximately 9 minutes) , and no significant intrinsic sympathomimetic or membrane stabilising activity at therapeutic dosages

Detailed description: The study will be a randomized double blinded study and will be carried by the Department of Anaesthesia at Beni-Suef University Hospital after obtaining approval from local research and ethical committee. Written informed consent will be obtained from each patient before operation. Aiming to assess of the early cognitive dysfunction after controlled hypotensive anesthesia with either dexmedetomidine or esmolol during middle ear surgeries

Eligibility criteria: Inclusion Criteria:

Patients aging 20-50 years ASA physical status I-II . Males , females

Exclusion Criteria:

1. hypertensive patient
2. Patients receiving sedatives as midazolam.
3. Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases.
4. Patients with cerebrovascular diseases.
5. Patients with impaired kidney function.
6. Patients with history of chronic liver diseases.
7. Patients with asthma, chronic obstructive lung diseases.
8. Patients with diabetes mellitus, coagulation disorders, pregnancy.
9. Patients with history of allergy to the drugs used in the study or patients with substance abuse .

Primary outcomes:
measure: assess the early cognitive dysfunction after controlled hypotensive anesthesia
timeFrame: MMS will performed at 1 hour, 6 and 24 hours postoperatively .The mximum score will be 30 points, a decrease of 2 or more will be considered as cognitive function decline. score less than 23 will be considered as cognitive impairmen
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University Hospital
Study officials:
affiliation: Assisstant proffesor of anesthesia
name: Samaa ak Rashwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04719312: Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture
Official title: Evaluation of Modification of the Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zygomatic Fractures
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex.

Postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain, post-operative edema, orbital movement, wound healing, scarring infection, and the post-operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion.

Postoperative clinical examinations along with radiographic examination was done to evaluate the position of zygoma and determine the adequacy of fracture reduction.


Eligibility criteria: Inclusion criteria

* Patients with ZMC fractures that requires open reduction with internal fixation.
* Adult patient between 20 and 50 years with no gender predilections.

Exclusion criteria

* Existing lacerations in the inferior and lateral periorbital regions.
* Comminuted fracture with bone loss.
* Existence of infection at the fracture line.
* Presence of Acute and chronic conjunctival diseases.

Primary outcomes:
measure: The exposure duration
timeFrame: at the surgery
measure: postoperative edema
timeFrame: after 1 week
measure: change in postoperative pain
timeFrame: 24 hours, 48 hours, 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT00054912: An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
Official title: An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colonic Neoplasms
Colorectal Neoplasms
Keywords: vaccine
colon
cancer
colorectal
neoplasm
Colonic Cancer
Colon Cancer
Cancer of the Colon
Lead sponsor: Epimmune
Sponsor class: INDUSTRY
First posted: 2003-02-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Colon Cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Colon Cancer, stage III
* At least four weeks following prior standard treatment, with no evidence of disease
* Must use adequate birth control

Exclusion Criteria:

* Prior cancer vaccine therapy or concurrent participation in any other investigational study
* A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment
* A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine
* Women who are pregnant, intend to become pregnant, or who are breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California School of Medicine
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Orlando
country: United States
facility: Cancer Centers of Florida
state: Florida
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
Study officials:
References:
Clinical trial NCT01873612: Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypoxia
Anesthetics
Conscious Sedation
Hypercapnia
Keywords: Dexmedetomidine
Propofol
Hypoxic ventilatory response
Hypercapnic ventilatory response
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overall aim with this project is to investigate the effect of dexmedetomidine on control of breathing in healthy volunteers and to compare it with propofol at the same degree of sedation.

Detailed description: 15 volunteers will be investigated for their hypoxic and hypercapnic ventilatory response during sedation with dexmedetomidine and propofol in a randomized cross-over study.

6 volunteers will be investigated for their repeated response to hypoxia and hypercapnia in order to validate the method.

Eligibility criteria: Inclusion Criteria:

1. Male
2. Age 18-40
3. American Society of Anesthesiologist´s classification (ASA) 1, i.e. healthy
4. No medication
5. No allergies
6. Non-smoker/no snuff, i.e. no nicotine intake
7. Normal weight, BMI \<26

Exclusion Criteria:

Snoring

Primary outcomes:
measure: Hypoxic ventilatory response
timeFrame: One day for each drug; before,during and after sedation with dexmeditomidine or propofol
Secondary outcomes:
measure: hypercapnic ventilatory response
timeFrame: One day for each drug; Before, during and after sedation with dexmedetomidine or propofol
Other outcomes:
measure: upper airway obstruction
timeFrame: One day for each drug: Before, during and after sedation with dexmedetomidine or propofol
measure: Plasma concentration
timeFrame: One day for each drug; At target sedation
measure: Sedation level
timeFrame: One day; During the whole experimental procedure
measure: Bispectral index
timeFrame: One day; During the whole experimental procedure
Locations:
city: Stockholm
country: Sweden
facility: Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital and Karolinska Institutet
name: Malin Jonsson Fagerlund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: