louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05232552: Study of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma
Official title: Safety and Efficacy of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma: a Phase 2 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM


Eligibility criteria: Inclusion Criteria:

1. newly diagnosed nasopharyngeal carcinoma confirmed by histology/cytology ;
2. N2-3 disease (UICC/AJCC 8th) with necrosis or/and ECM;
3. with sufficient organ and bone marrow function;
4. ECOG (Eastern US Cooperative Oncology Group) score \< 3
5. with good compliance and cooperation to treatment and follow-up
6. agree to use effective methods of contraception during the study period and within 180 days of the last study administration.

Exclusion Criteria:

1. patients with other malignant tumors diagnosed within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)\]
2. patients with bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers or fracture;
3. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of the analysis method) or co infection with hepatitis B and C.
4. Active infection (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs) or fever of unknown origin \>38.5℃ 1 weeks ago (except for tumor related fever determined by researchers).
5. Abnormal coagulation (INR \> 1.5 or APTT \> 1.5 × ULN), bleeding tendency or undergoing thrombolysis or anticoagulation. Long term anticoagulation with warfarin or heparin or long-term antiplatelet therapy is required.
6. serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study
7. Allergy to the drugs in the study

Primary outcomes:
measure: ORR
timeFrame: induction phase ; 3 months after chemoradiation
Secondary outcomes:
measure: PFS
timeFrame: 3year
measure: LRR
timeFrame: 3 years
measure: RRR
timeFrame: 3 years
Other outcomes:
Locations:
city: Hangzhou,
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT00063752: Safety Study of PI-0824 to Treat Pemphigus Vulgaris
Official title: An Open-Label, Dose-Escalation, Phase I Clinical Study to Assess the Safety of PI-0824 in Patient With Pemphigus Vulgaris Requiring Daily Corticosteroid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pemphigus Vulgaris
Lead sponsor: Peptimmune
Sponsor class: INDUSTRY
First posted: 2003-07-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus vulgaris is safe.

Detailed description: Pemphigus vulgaris (PV) is an autoimmune disease affecting approximately 40,000 people worldwide. People with PV produce antibodies that attack the cells of the skin, resulting in blisters which, if left untreated, can lead to devastating infections and discomfort. Currently, most doctors who treat patients with PV will prescribe high-dose steroids and drugs that suppress the immune system in an effort to decrease the production of these antibodies. Unfortunately these medications are associated with serious and difficult side effects that often result in the discontinuation of their use. Peptimmune, Inc. has developed a new therapy for the treatment of PV, PI-0824. The goal of this therapy is to reduce the production of antibodies that cause PV blisters by acting only on the disease causing components of the immune system. It is hoped that use of PI-0824 will reduce or potentially eliminate the need for high dose steroids and drugs that suppress the immune system.

Eligibility criteria: Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Salisbury
country: United States
facility: East Coast Clinical Research
state: Massachusetts
city: East Setauket
country: United States
facility: Stony Brook Dermatology Associates
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01977352: Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
Official title: Comparison of Cumulative Opioid Consumption After Interscalene Brachial Plexus Block With Liposomal Bupivacaine (Exparel; 88 mg in 20 cc) Versus Bupivacaine 0.25% for Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Pain
Rotator Cuff Tear
Keywords: Exparel
Liposomal Bupivacaine
Arthroscopic Shoulder Surgery
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 42
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.


Eligibility criteria: Inclusion Criteria:

* English speaking adults (age \>17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.

Exclusion Criteria:

* Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (\< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.

Primary outcomes:
measure: Total Opioid Consumption
timeFrame: Post op Day 1, post op Day 2, post op day 3, post op 1 week
Secondary outcomes:
measure: Quality of Analgesia
timeFrame: Post op Day 1, post op Day 2, post op day 3, post op 1 week
measure: Sensory and Motor Block
timeFrame: at 20 min and at 1 hour
measure: Time to First Pain Medicine
timeFrame: 72 hours
measure: Time to Discharge Home
timeFrame: 72 hours
measure: Incidence of Postoperative Nausea and Vomiting
timeFrame: 72 hours
measure: Sleep Quality
timeFrame: Post op Day 1, post op Day 2, post op day 3, post op 1 week
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Ali Shariat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02954952: EEG Data Collection to Evaluate New Patient State Index Performance
Official title: EEG Data Collection to Evaluate New Patient State Index Performance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2016-11-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective, single-center, cohort study in patients undergoing surgical procedures to collect data using Masimo SedLine EEG device in order to evaluate a newer version of PSI measurement against an older version of PSI measurement.


Eligibility criteria: Inclusion Criteria:

* ASA status of I, II, or III.
* Subjects undergoing general surgery.
* neurologically intact patients (e.g. no history or presence of traumatic brain injuries, neurological diseases, etc.).

Exclusion Criteria:

* subjects with any deformities, diseases, or for any other reason that may present proper fit and application of SedLine sensors.
* inability to obtain subject's physiological, vital, demographics, and real time anesthesia data.
* Subjects who are pregnant.
* known history of drug abuse.
* subjects deemed not suitable for study at the discretion of the Principal Investigator.

Primary outcomes:
measure: Wake up Times, PSI 1.X vs. PSI 2.X
timeFrame: From the end of anesthesia to the time of Return of Consciousness
Secondary outcomes:
Other outcomes:
measure: Total Anesthesia Drug Used, PSI 1.X vs. PSI 2.X
timeFrame: Through study completion
measure: Frequency of Somatic Events, PSI 1.X vs. PSI 2.X
timeFrame: Through study completion
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Michael Ramsay, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04681352: A Study of Octave System for Improving Lines and Wrinkles of the Décolleté
Official title: Prospective, Evaluator-blind, Multicenter Study to Assess the Safety and Effectiveness of Treatment With the Octave System for Improving Lines and Wrinkles of the décolleté
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Décolleté Wrinkles
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ulthera, Inc
First posted: 2020-12-23
Enrollment: 99
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.


Eligibility criteria: Inclusion Criteria:

- Moderate to severe fine lines, wrinkles, laxity, and crepiness of the décolleté that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Scarring in area(s) to be treated.
* Active implants (e.g., pacemakers or defibrillators), ports, or metallic implants in area(s) to be treated.
* Breast implants or is planning to receive breast implants during the study.
* Inability to take pre-treatment medications due to a pre-existing condition, medication allergy, or medical issue that, at the discretion of the treating investigator, is contraindicated.

Primary outcomes:
measure: Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90
timeFrame: Day 90
Secondary outcomes:
measure: Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180
timeFrame: Day 180
measure: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Day 1 up to end of the study (Up to Day 180)
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Merz Investigational Site #0010395
state: California
city: San Mateo
country: United States
facility: Merz Investigational Site #0010321
state: California
city: Norwalk
country: United States
facility: Merz Investigational Site #0010352
state: Connecticut
city: Miami
country: United States
facility: Merz Investigational Site #0010416
state: Florida
city: Chicago
country: United States
facility: Merz Investigational Site #0010346
state: Illinois
city: New York
country: United States
facility: Merz Investigational Site #0010439
state: New York
city: New York
country: United States
facility: Merz Investigational Site #0010452
state: New York
city: Wilmington
country: United States
facility: Merz Investigational Site #0010396
state: North Carolina
city: Plano
country: United States
facility: Merz Investigational Site #0010125
state: Texas
city: Spokane
country: United States
facility: Merz Investigational Site #0010392
state: Washington
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References:
Clinical trial NCT06017752: Middle School Teacher Module for a Brief Bullying Intervention Program
Official title: Development, Acceptability, and Short-Term Outcomes of a Teacher Module for a Brief, Bullying Bystander Intervention for Middle School Students in Rural, Low-Income Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bullying
Lead sponsor: Boise State University
Sponsor class: OTHER
Collaborators: name: Mental Research Institute
First posted: 2023-08-30
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluates the feasibility and short-term outcomes of a teacher training designed as a companion module to a bullying bystander intervention (STAC) for middle school students in rural communities. The aim of this project is to provide a brief, low-cost intervention that can be easily disseminated as part of a school-based bullying prevention program to address this important public health problem.


Eligibility criteria: Inclusion Criteria:

* Being a teacher of an adolescent enrolled in grades 6, 7, or 8 in a participating middle school in Idaho.
* Speaks and reads English.
* Consents to participate.

Exclusion Criteria:

* Speaks and reads only a language other than English.
* Does not consent for participation.

Primary outcomes:
measure: Knowledge and Confidence to Support Defenders
timeFrame: pre-training (baseline); immediate post-training (50 minutes)
measure: Confidence Managing Bullying
timeFrame: pre-training (baseline); immediate post-training (50 minutes)
measure: Comfort Managing Bullying
timeFrame: pre-training (baseline); immediate post-training (50 minutes)
measure: Bullying Self-Efficacy
timeFrame: pre-training (baseline); immediate post-training (50 minutes)
measure: Number of Participants Reporting a Score of 4 or 5 on Intention to Use Teacher STAC Strategies
timeFrame: immediate post-training (50 minutes)
Secondary outcomes:
measure: Number of Participants Reporting a Score of 3 or 4 on Acceptability and Relevance of the Teacher STAC Training
timeFrame: immediate post-training (50 minutes)
Other outcomes:
Locations:
city: Boise
country: United States
facility: Boise State Univerity
state: Idaho
Study officials:
References:
Clinical trial NCT05860452: Effectiveness of TAP (Transversus Abdominis Plane) Block for Abdominal Aortic Surgery
Official title: Effectiveness of TAP (Transversus Abdominis Plane) Block for Postoperative Pain Relief After Abdominal Aortic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Abdominal Aortic Stenosis
Syndrome, Leriche
Keywords: Abdominal aorta, TAP
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn about the effectiveness of TAP block for pain relief after vascular surgery on the abdominal aorta.

The main question the investigators are looking to answer is whether the TAP block lowers the dose of opioid required after abdominal aortic surgery.

Detailed description: The surgery on the abdominal aorta requires extended haemodynamic monitoring and is performed under general anaesthesia. After applying general anaesthesia, the patients will receive a TAP block (subcostal approach) before the start of the surgery.

During the procedure the patients will receive both opioid and nonopioid analgesics, as part of the standard perioperative protocol for abdominal aortic surgery.

After the procedure all patients will receive following the standard protocol for pain relief after abdominal aortic surgery - NSAIDs and nonopioid analgesics regularly. All patients will postoperatively receive opioid as a rescue drug as needed (PCA).

Participants will be randomly allocated in two groups, where one group will receive local anaesthetic for the TAP block and the control group will receive normal saline for the TAP block. The anaesthetist, the nurses and doctors in the postoperative care will all be blinded as to the group in which each patient is allocated.

The participants will be followed from surgery until discharge from hospital.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted for an elective vascular surgery on abdominal aorta that agree and give written consent to be included in the study.

Exclusion Criteria:

* Patients allergic to the drugs we will use in the study, local anaesthetic, nonopioid analgesics, NSAIDs.
* Patients with pain syndromes that are preoperatively already on any kind of chronic pain therapy.
* Patients that will experience surgical complications that requires reoperation will be excluded postoperatively.

Primary outcomes:
measure: Cumulative dose of opioid in the first 48 hours after surgery
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: up to 2 weeks
measure: Patient satisfaction with pain relief
timeFrame: up to 7 days postoperatively
measure: Return of peristalsis
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMCLjubljana
Study officials:
affiliation: UMC Ljubljana
name: Gordan Mijovski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02490852: Study of Nutritional Suitability of a New Infant Formula for Term Infants
Official title: Study of Nutritional Suitability of a New Infant Formula for Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Lead sponsor: Ausnutria Hyproca B.V.
Sponsor class: INDUSTRY
First posted: 2015-07-07
Enrollment: 304
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.


Eligibility criteria: Inclusion Criteria:

* Healthy full term infant (37-42 weeks of gestational age)
* Birth weight 2,500 to 4,500 g
* Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation
* Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary
* Informed consent signed by parent(s)/caregiver(s)

Exclusion Criteria:

* Congenital illness or malformation that may affect infant feeding or normal growth
* Gastrointestinal disorders
* Suspected or known allergy to milk protein for formula groups
* Known food allergies in parents or siblings for formula groups
* Multiples
* Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment
* Infant participating in another clinical study
* Infant's family unable to comply with the protocol according to the investigators's assessment

Primary outcomes:
measure: Weight gain
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
city: Dakovo
country: Croatia
city: Dubrovnik
country: Croatia
city: Kutina
country: Croatia
city: Split
country: Croatia
city: Vukovar
country: Croatia
city: Zadar
country: Croatia
city: Zagreb
country: Croatia
city: Zapresic
country: Croatia
city: Bramsche
country: Germany
city: Hamm
country: Germany
city: Herford
country: Germany
city: Mannheim
country: Germany
city: Monchengladbach
country: Germany
city: Wesel
country: Germany
city: Wuppertal
country: Germany
city: Barcelona
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Kinderärztliche Gemeinschaftspraxis
name: Falco Panzer, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02277652: Endotracheal Intubation Devices
Official title: Comparison of Four Different Endotracheal Intubation Devices Performed by Emergency Medical Professionals: a Manikin Study With 6 Airway Scenarios
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the four different intubation devices in 6 different scenarios.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Time to intubation
timeFrame: 1 month
Secondary outcomes:
measure: Success of intubation
timeFrame: 1 month
measure: POGO score
timeFrame: 1 month
measure: VAS score
timeFrame: 1 month
measure: Cormack-Lehane grading
timeFrame: 1 month
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Andrzej Kurowski
role: PRINCIPAL_INVESTIGATOR
References: