louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06125236: Registration of Acute Ischemic Stroke With Large and Medium-sized Vascular Occlusion in Southwest China(LMVOS)
Official title: Registration of Acute Ischemic Stroke With Large and Medium-sized Vascular Occlusion in Southwest China(LMVOS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Lead sponsor: The Affiliated Hospital Of Southwest Medical University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke due to large- or medium-vessel occlusion will be enrolled and no additional exclusion criteria are set.

Brief summary: This study is designed to observe the treatment options in real-world clinical practice as well as the safety and efficacy of different treatment strategies.

Detailed description: LMVOS is a prospective, real-world registry lasting for 22 years. A total of 8000 patients with large- or medium-vessel occlusion will be enrolled.

Eligibility criteria: Inclusion Criteria:

The clinical diagnosis is acute ischemic stroke with large- or medium- vessel occlusion (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018).

Informed consent from the patient or surrogate.

Exclusion Criteria:

No additional exclusion criteria.

Primary outcomes:
measure: modified Rankin Scale (mRS) score
timeFrame: 90±7 days
Secondary outcomes:
measure: Excellent functional outcome
timeFrame: 90±7 days
measure: Good functional outcome
timeFrame: 90±7 days
measure: mRS 0-3
timeFrame: 90±7 days
measure: Change of National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 24 hours
measure: Change of National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 7 days
measure: Symptom-to-thrombolysis time (STT)
timeFrame: 24 hours
measure: Door-to-Needle Time
timeFrame: 24 hours
measure: Door-to-Puncture Time (DPT)
timeFrame: 24 hours
measure: Onset-to-recanalization time
timeFrame: 24 hours
measure: Door-to-Recanalization Time (DRT)
timeFrame: 24 hours
measure: Puncture-to-recanalization time
timeFrame: 24 hours
Other outcomes:
measure: Incidence of clinically significant intracranial hemorrhage
timeFrame: 36 hours
measure: Incidence of any intracranial hemorrhage
timeFrame: 36 hours
measure: All-cause mortality
timeFrame: 90±7 days
measure: Complications related to intravenous thrombolysis
timeFrame: up to 7 days
measure: Complications related to endovascular treatment
timeFrame: up to 7 days
Locations:
city: Luzhou
country: China
facility: Affiliated Hospital of Southwest Medical University
Study officials:
affiliation: Department of Neurology, Affiliated Hospital of Southwest Medical University, LuZhou, China.
name: Zhengzhou Yuan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05875636: GLP-1 Receptor Agonist Use and Incidence of Retained Gastric Food on Endoscopy
Official title: GLP-1 Receptor Agonist Use and Incidence of Retained Gastric Food on Endoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Content Aspiration
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will consist of patients who have appropriately fasted, and are scheduled for an esophagogastroduodenoscopy (EGD). Patients will fall in to two groups: 1) taking a GLP-1 receptor agonist or 2) not taking a receptor agonist medication.

Brief summary: This study will enroll patients ages 18 and over who are in one of the following groups 1) taking a GLP-1 receptor agonist medication 2) not taking a GLP-1 receptor agonist (control group), are undergoing EGS and have appropriately fasted. Study data will be collected in the form of qualitatively observing whether the stomach is empty as expected, or contains solid or clinically relevant liquid contents.


Eligibility criteria: Inclusion Criteria

* Adults 18 years of age and older presenting for esophagogastroduodenoscopy (EGD)
* One of the following groups:

  * GLP-1 receptor agonist cohort: active treatment with any GLP-1 receptor agonist therapy within prior 30 days
  * Control cohort: not taking a GLP-1 receptor agonist medication
* Appropriately fasted per ASA Fasting Guidelines

Exclusion Criteria

* Simultaneous bowel preparation/planned dual endoscopy with colonoscopy
* Any pre-planned alteration to standard fasting guidelines (ASA NPO guidelines)
* Emergency endoscopic procedure
* Concern for active GI bleeding
* Food impaction/foreign body as indication for procedure
* Gastric outlet obstruction/bowel obstruction
* Achalasia
* Zenker's diverticulum
* History of esophageal or gastric surgery
* Active pregnancy
* Chronic daily opioid therapy ≥ 15 MMEs per day
* Prokinetic agent use (i.e. metoclopramide)
* Inability or unwillingness of subject to give informed consent

Primary outcomes:
measure: Retained gastric food
timeFrame: From time of enrollment until the end of surgery, assessed up to 4 weeks
Secondary outcomes:
measure: Incidence of pulmonary aspiration event
timeFrame: From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Phillip R Wilson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06552936: Combination Therapy Effect of Laser on Wound Healing and Bone Regeneration of Dental Sockets
Official title: Combination Therapy Effect of Laser on Wound Healing and Bone Regeneration of Dental Sockets
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Extraction
Keywords: Tooth socket, Laser, wound healing, bone regeneration, pain
Lead sponsor: Sharif Medical Research Center
Sponsor class: OTHER
Collaborators: name: Universiti Sains Malaysia
First posted: 2024-08-14
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if the laser works to improve wound healing and bone regeneration after tooth extraction. The main question it aims to answer is:

Does laser therapy improve wound healing and bone regeneration after tooth extraction?

Researchers will compare a laser to sham laser therapy to see if the laser enhances wound healing and bone regeneration.

Participants will:

Have exposure to laser or sham laser therapy immediately after tooth extraction Record their pain intensity on days 2, 4, 6 and 14 Visit the clinic after 10 days for follow-up Again, visit the clinic after 4 months for evaluation


Eligibility criteria: Inclusion Criteria:

* At least 21 years old, regardless of gender
* Non-traumatic tooth extraction of the lower jaw is indicated
* Willing for dental implant surgery
* Dental appointments are available at the study place
* Absence of active infection at the extraction site
* Signed informed permission is provided.

Exclusion Criteria:

* Pregnant, lactating, and menopausal women
* Smokers
* Those having head and neck radiotherapy
* Those with any sort of acute infection (e.g., periodontal abscess), immune deficiency, or metabolic conditions such as diabetes mellitus and osteoporosis
* Patients will also be eliminated if they have a complication during surgery, such as bleeding or operational difficulties, or if the procedure takes longer than 90 minutes.

Primary outcomes:
measure: Wound healing will be assessed in both the experimental and control groups.
timeFrame: 1 year
measure: Bone regeneration will be assessed in both the experimental and control groups.
timeFrame: 1 year
Secondary outcomes:
measure: Pain intensity will be measured in both the experimental and control groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sharif Medical and Dental College
state: Punjab
city: Lahore
country: Pakistan
facility: Sharif Medical and Dental College
Study officials:
affiliation: Sharif Medical and Dental College
name: Amna N Khan, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06272136: Liom Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM)
Official title: An Exploratory Study to Assess the Accuracy in the Normo- to Hyperglycemic Range of the Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM), in Trial Participants with Type 1 or Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Type2diabetes
Keywords: Hyperglycemia
Diabetes Mellitus
Transcutaneous
Spectral fingerprint
Non-invasive
Lead sponsor: Liom Health AG
Sponsor class: INDUSTRY
Collaborators: name: Profil Institut für Stoffwechselforschung GmbH
First posted: 2024-02-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single-centre, multiple cohort, open study.

Detailed description: The study will include 5 cohorts. After each cohort, optimisation of the Spiden Clinical Demo 2.0 system and machine learning models may be pursued before the next cohort is started. Trial participants with type 1 or type 2 diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* Male or female trial participant with clinically diagnosed type 1 or type 2 diabetes for at least 1 year.
* Age between 18 and 65 years, both inclusive.
* Treated with insulin and/or oral antidiabetic drugs (OADs; type 2 only), multiple dosing insulin therapy (MDI), continuous subcutaneous insulin infusion (CSII) or a hybrid closed loop system.

Exclusion Criteria:

* Known or suspected hypersensitivity to any of the components of the Liom Clinical Demo 2.0.
* Trial participant with any injury, infection, atypical skin condition (e.g., hyperkeratosis, hyperpigmentation) of or tattoo on the wrists.
* Presence or history of a cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.

Primary outcomes:
measure: Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia
timeFrame: The data is collected during the study procedure (up to 5 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil for Stoffwechselforschung GmbH
state: Nordrhein-Westfallen
Study officials:
affiliation: Profil for Stoffwechselforschung GmbH, Neuss, Germany
name: Marc Stoffel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00917436: Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
Official title: Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute low back pain of recent onset (less than 7 days) and defined by spontaneous pain intensity at rest more than or equal to 50mm of the visual analog scale.
* Presence of lumbar muscular contracture

Exclusion Criteria:

* Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins
* Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol
* Renal failure (serum creatinine \> 160 µmol/l or \> 1.80 mg/dl) and/or severe hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase and/or total bilirubin \> 2 Upper normal limit).
* Positive history of cerebro-vascular accidents or myocardial infarction in the six months prior the inclusion.
* Severe heart failure.
* Myopathy / myasthenia.
* Patients treated during two days prior to inclusion with steroidal agents.
* Known or suspected hypersensitivity to thiocolchicoside.
* Known or suspected hypersensitivity to nonsteroidal anti-inflammatory drugs
* History of active peptic ulcer or gastro intestinal bleeding.
* History of nonsteroidal anti-inflammatory drugs induced allergic asthma.
* Concomitant treatment with 2-agonists (i.e. clonidine).
* Pregnant or breast feeding women.
* Females of child bearing potential, not taking adequate contraception.
* Patients with history of alcohol, drugs or narcotics abuse.
* Previous inclusion in this study or in another study in the past 6 months.

Primary outcomes:
measure: Pain score evaluated by patient-rated visual analog scale: the levels of spontaneous pain is indicated by the patient by means of a 10 centimetre non-graduated scale, in which the patient could estimate the intensity of pain
timeFrame: During patient visits: day 1, day 3 and day 5 to 10
Secondary outcomes:
measure: Mobility Hand-to-floor distance is evaluated by a simple graduated bar (0 value at floor).
timeFrame: During patient visits: day 1, day 3 and day 5 to 10
measure: Disability Questionnaire (Roland Morris)
timeFrame: During patient visits: day 1, day 3 and day 5 to 10
measure: Physician rated Clinical Global Impression Scale
timeFrame: During patient visits: day 1, day 3 and day 5 to 10
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Manish MISTRY
role: STUDY_DIRECTOR
References:
Clinical trial NCT04622436: Early Recognition of Hypoxia in Pediatric Patient Sedation
Official title: Comparison of MicroStream Capnography and Pulseoxymeter in Sedation of Pediatric Patients Undergoing Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Desaturation of Blood
Keywords: Hypoxia
Desaturation
MicroStream Capnography
Pulseoxymeter
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-11-10
Enrollment: 4
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients under ages 18

Brief summary: Early recognition of hypoxia through monitoring in sedation practices in pediatric patients

Detailed description: In pediatric Magnetic Resonance Imaging, sedation is applied to pediatric patients of all age groups from newborn to adolescence in order to prevent the anxiety and movement of the patients during the imaging. It was aimed to compare the capnograph and pulse oximeter used for early detection of hypoxia in patient follow-up and to monitor the depth of sedation with the sedation score in the recovery room.

Eligibility criteria: Inclusion Criteria:

* Patients under 18 years of age who underwent magnetic resonance imaging with sedoanalgesia

Exclusion Criteria:

* Patients over the age of 18,
* Those who do not speak Turkish,
* Presence of deformities in the nose and forehead,
* Those with nail polish and henna on their nails

Primary outcomes:
measure: Early recognition of hypoxia
timeFrame: during the procedure
measure: the changes in partial oxygen saturation
timeFrame: during the procedure
Secondary outcomes:
measure: Sedation score
timeFrame: during the procedure
measure: recovery time
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Education and Research Hospital
state: Yıldırım
Study officials:
References:
Clinical trial NCT06477536: Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis
Official title: A Phase IIb, Long-Term Extension Study to Evaluate the Safety and Efficacy of HB0034 in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Generalized Pustular Psoriasis
Lead sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-27
Enrollment: 33
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: This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).

Detailed description: This study will also evaluate the pharmacokinetic (PK) profile of HB0034 and explore the immunogenicity of HB0034 in subjects with GPP

Eligibility criteria: Inclusion Criteria:

* Patients participated in the preceding placebo-controlled Phase 2 study （HB0034-04）and completed at least the Week 12 visit of the HB0034-04 study
* Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
* Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;
* Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules

Exclusion Criteria:

* Patients who are experiencing GPP flare

Primary outcomes:
measure: Safety endpoints include the proportion of subjects with TEAEs
timeFrame: 0-24 weeks
Secondary outcomes:
measure: The recurrence of GPP flare during the study
timeFrame: 0-24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital (PKUPH)
city: Beijing
country: China
facility: Peking University People's Hospital
city: Hangzhou
country: China
facility: The Second affiliated Hospital zhejiang University School of Medicine
Study officials:
affiliation: Peking University People's Hospital (PKUPH)
name: Jianzhong Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956436: Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
Official title: A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: Liver Cancer
Hepatocellular Carcinoma
Sorafenib
HCC
BIIB022
Open-Label
IGF-1R
Nexavar
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-08-11
Enrollment: 40
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: This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
* Child-Pugh score A5 or A6.
* ECOG Performance Status of ≤2.

Exclusion Criteria:

* Known central nervous system or brain metastases.
* Prior anti-IGF-1R therapy.
* Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
* Concurrent anticancer therapy.
* History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
* Acute hepatitis
* Fibrolamellar HCC

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate the PK profile of BIIB022 and sorafenib in this study population
timeFrame: 6 months
measure: To assess the anti-tumor response in this study population
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Resesarch Site
state: Colorado
city: Ocoee
country: United States
facility: Resesarch Site
state: Florida
city: Indianapolis
country: United States
facility: Resesarch Site
state: Indiana
city: Boston
country: United States
facility: Resesarch Site
state: Massachusetts
city: New York
country: United States
facility: Resesarch Site
state: New York
city: Norfolk
country: United States
facility: Resesarch Site
state: Virginia
city: Singapore
country: Singapore
facility: Resesarch Site
city: Tainan
country: Taiwan
facility: Resesarch Site
city: Taipei
country: Taiwan
facility: Resesarch Site
city: Tao-Yuan
country: Taiwan
facility: Resesarch Site
city: Edgbaston
country: United Kingdom
facility: Resesarch Site
state: Birmingham
Study officials:
References:
Clinical trial NCT06669936: Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection
Official title: Efficacy Fo Oral Capsule FMT Combined with Bezlotoxumab Following Initial Failure of FMT Alone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent C. Difficile Infection
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with history of recurrent C. difficile infection who suffered a relapse without a new antibiotic provocation within 90 days of FMT.

Brief summary: The goal is to evaluate the benefit of adding bezlotoxumab to repeat fecal microbiota transplantation (FMT) in patients with recurrent Clostridioides difficile infections after failure of FMT alone.

Detailed description: Initial failure of FMT in breaking the cycle of recurrent C. difficile infections is associated with a greater risk of subsequent failure. Previous analysis showed that FMT failure is associated with delayed repair of fecal microbiota at one week after administration. The hypothesis underlying this trial is that increased symptom-free interval by administration of bezlotoxumab can improve the outcomes of a second FMT.

Eligibility criteria: Inclusion Criteria:

1. Informed consent.
2. Diagnosis of recurrent C. difficile infection based on symptoms and laboratory confirmation.
3. Failure of standard antibiotic therapies prior to the initial FMT

Exclusion Criteria:

1. Pregnancy.
2. Class III or above heart failure.

Primary outcomes:
measure: Clinical failure
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: