louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05213754: Acute Ischemic Stroke Registry for Endovascular Treatment
Official title: Acute Ischemic Stroke Registry for Endovascular Treatment in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke
Endovascular treatment
Outcome
Registry
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients with large vessel occlusion receiving endovascular treatment.

Brief summary: The Acute Ischemic Stroke Registry for Endovascular Treatment (AIS-EVT) is an academic, prospective, multicenter, observational registry study. Consecutive stroke patients treated with endovascular treatment will be enrolled in stroke centers. Baseline information and clinical follow-up information at 90 days of stroke onset are collected. Data collected include demographics, comorbidities, pathogenesis, blood pressures, stroke severity on admission, time intervals, reperfusion condition, and functional outcome, et al.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of acute ischemic stroke;
2. Imaging confirmed intracranial large vessel occlusion: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);
3. Initiation of any type of endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, aspiration, angioplasty, and stenting;
4. Verbal and written informed consent was provided at the time of admission by patients or their legal authorized representatives.

Exclusion Criteria:

No evidence of large vessel occlusion on digital subtraction angiography.

Primary outcomes:
measure: The modified Rankin Scale score at 90 days
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT02362854: Efficacy of Diode Laser in Peri-implantitis
Official title: A Randomized Clinical Trial of an Adjunct Diode Laser Application in the Treatment of Peri-implantitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant
Peri-Implantitis
Alveolar Bone Loss
Complications
Keywords: dental implant
laser
diode laser
peri-implantitis
bacterial count
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University Research Fund
First posted: 2015-02-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the efficacy of a diode laser (DL) as an adjunct to conventional scaling in the treatment of mild-to-moderate peri-implantitis. A prospective clinical, radiographic and microbiologic split-mouth study was conducted to test the following null hypothesis; adjunct application of a diode laser, in the conventional treatment of peri-implantitis, are not associated with a statistically significant difference regarding the microbial counts, marginal bone loss and peri-implant parameters.

Detailed description: Efficacy of a diode laser (DL) in peri-implantitis was investigated. 48 implants diagnosed with peri-implantitis were included. In addition to the conventional scaling and debridement, random 24 implants were lased by a DL. Periodontal indexes, microbiologic specimens and radiographs were used for assessment. Baseline parameters were similar between groups. After six months laser group revealed higher MBL than the control group. Microbiota of the implants were found unchanged after one month. DL appears to have no additional positive influence on the peri-implantitis treatment.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* No local and systemic health problems prohibit the study interventions
* Bi-lateral implants with peri-implantitis diagnosis

Exclusion Criteria:

* Local and systemic health problems prohibiting the study interventions

Primary outcomes:
measure: Bacterial counts
timeFrame: One month
Secondary outcomes:
measure: Marginal Bone loss
timeFrame: Six months
Other outcomes:
measure: Peri-implant health indexes
timeFrame: one and six months
Locations:
city: Istanbul
country: Turkey
facility: Department of Oral Implantology, Faculty of Dentistry, Istanbul University
state: Capa
Study officials:
affiliation: Istanbul University, Faculty of Dentistry
name: Volkan Arısan, Ass.Prof.Dr.
role: STUDY_CHAIR
affiliation: Istanbul University, Faculty of Dentistry
name: Cuneyt Karabuda, Prof.Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05601154: Fluoride in Saliva After Use of Fluoride Toothpastes Followed by Fluoride Mouthrinses
Official title: Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter Toothpastes Followed by Fluoride Mouthrinses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dental Caries
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. The study population will include twenty individuals, over the age of 18 years-old, from both genders, with normal oral health conditions and salivary flow rate, no need of urgent dental needs, from the Ann Arbor, MI area. Participants will be recruited from the University of Michigan School of Dentistry, in Ann Arbor, MI. Using a crossover design, twenty participants will be rotating through 4 different combinations of fluoride toothpaste (over-the-counter or prescription concentration) and fluoride mouth rinse (yes or no), in a 2 x 2 factorial design. Treatments to be tested will be as followed: Group #1 will brush with 1,100 ppm F (over-the-counter) toothpaste; Group #2 will brush with 1,100 ppm F (over-the-counter) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse; Group #3 will brush with 5,000 ppm F (prescription) toothpaste; Group #4 will brush with 5,000 ppm F (prescription) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse.


Eligibility criteria: Inclusion Criteria:

* Sign informed consent form
* Participant understands and agrees to comply with the study protocol, and confirms availability for the entire duration of the study
* 18 years of age or older
* Good general health
* Good oral health, with no urgent treatment needs
* Normal salivary flow rate

Exclusion Criteria:

* Fail to understand or to agree to follow the study protocol
* Reduced salivary flow rate
* Poor general or oral health conditions

Primary outcomes:
measure: Area under the curve of fluoride bioavailability in saliva
timeFrame: 0 to 60 minutes after the interventions
Secondary outcomes:
measure: Maximum fluoride concentration in saliva
timeFrame: 0 to 60 minutes after the interventions
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: School of Dentistry, University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT05000554: The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer
Official title: The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery


Eligibility criteria: Inclusion Criteria:

1. Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).
2. Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.
3. The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
4. No bulky lymph node metastasis is detected by abdominal CT.
5. No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
6. No clinically apparent distant metastasis.
7. Karnofsky performance status ≥70%.
8. Sufficient oral intake.
9. No previous treatment with chemotherapy or radiation therapy for any tumors.
10. No previous surgery for the present disease.
11. Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses. White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0\*104/mm3 (5.0\*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
12. No need for emergency surgery due to bleeding or perforation of the primary tumor.
13. No mechanical obstruction.
14. Written informed consent.

Exclusion Criteria:

1. Past history of upper abdominal surgery.
2. Past history of surgery for the gastrointestinal tract.
3. Body mass index exceeding 30 kg/m2.

Primary outcomes:
measure: pCR rate
timeFrame: 30 days
Secondary outcomes:
measure: ORR
timeFrame: 30 days
measure: PFS
timeFrame: 3 years
measure: OS
timeFrame: 3 years
measure: postoperative complication
timeFrame: Up to 30 days post-operative
measure: operative mortality
timeFrame: Up to 30 days post-operative
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT00883454: Estimation of Functional Liver Reserve Using Cholinesterases
Official title: Estimation of Functional Liver Reserve in Patients With Hepatocellular Carcinoma in Cirrhosis: the Value of Preoperative Cholinesterases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Cirrhosis
Liver Neoplasm
Liver Disease
Keywords: hepatocellular carcinoma
liver tumor
cirrhosis
liver resection
tumor staging
liver disease staging
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The records of approximately 245 consecutive patients who were referred at our Unit because of HCC were reviewed. Among those, 191 (78%) were submitted to surgery, and 181 (74%) were resected. The patients excluded from surgery were addressed to symptomatic treatments because of advanced disease or impaired liver functional reserve, or to percutaneous ablation therapy according to our policy. Among resected patients, there were 145 (80%) men and 36 (20%) women, with median age of 67 years (range 36-87 years).

Brief summary: Estimation of functional liver reserve in patients with hepatocellular carcinoma (HCC) in cirrhosis is of paramount importance to properly select candidates for surgical resection. Together with the value of bilirubin, the presence/absence of ascites and esophageal varices, and the rate of residual liver volume, which are our current parameters to measure functional liver reserve, the investigators sought to investigate the value of preoperative cholinesterases (CHE) in predict postoperative adverse outcome after hepatic resection for HCC.


Eligibility criteria: Inclusion Criteria:

1. Total bilirubin \< 2 mg/dl
2. No ascites
3. No esophageal varices, or esophageal varices eradicated by endoscopy
4. Liver volume:

   * residual liver volume \> or = 40% if total bilirubin \< 1 mg/dl
   * residual liver volume \> or = 50% if total bilirubin between 1 and 1.5 mg/dl
   * only limited resection if total bilirubin \> 1.5 mg/dl
5. Portal vein embolization was selected in any case in whom RLV did not fit the previous requirements.

Exclusion Criteria:

1. Total bilirubin \> 2 mg/dl
2. Refractory ascites
3. Esophageal varices

Primary outcomes:
measure: The primary outcome was to investigate the value of preoperative cholinesterases in predict postoperative adverse outcome after hepatic resection for hepatocellular carcinoma in cirrhosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano, Milan
country: Italy
facility: Liver Surgery Unit, Third Department of Surgery, University of MIlan, IRCCS Istituto Clinico Humanitas
state: Milan
Study officials:
References:
Clinical trial NCT04004754: Outcomes of Complicated CL in Ethiopia Treated With Miltefosine
Official title: Documenting Clinical Outcomes of Patients Receiving Miltefosine for the Treatment of Complicated Cutaneous Leishmaniasis in Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Leishmaniases
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: University of Gondar
name: Boru Meda Hospital
First posted: 2019-07-02
Enrollment: 94
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with complicated CL receiving miltefosine

Brief summary: Cutaneous Leishmaniasis in Ethiopia causes severe dermatological mutilations. Forms that require systemic treatment are cLCL, MCL, and DCL. National guidelines recommend equally all drugs that are also used for VL treatment. Miltefosine is one of these recommended medications but remains underused due to scarcity of drugs.

Outcomes of patients receiving miltefosine have never been documented systematically in Ethiopia until today. This is needed to provide evidence to advocate for increased access to miltefosine in Ethiopia, and to establish baseline data for future research on CL treatment options. The aim of this study is to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using miltefosine within a routine care setting located in an endemic area in Ethiopia.


Eligibility criteria: Inclusion Criteria:

* Parasitologically or clinically confirmed diagnosis of Leishmaniasis
* Clinical routine care decision to initiate miltefosine

Exclusion Criteria:

* Medical emergencies, underlying chronic conditions, or other circumstances that make participation in this study medically or otherwise inadvisable

Primary outcomes:
measure: Assess final treatment response
timeFrame: Day 90
Secondary outcomes:
measure: Early and late treatment response
timeFrame: Day 28, Day 180
measure: Treatment failure
timeFrame: Day 90, Day 180
measure: Adherence
timeFrame: Day 28
measure: Predictors of cure
timeFrame: Day 90
Other outcomes:
Locations:
city: Boru
country: Ethiopia
facility: Boru Meda Hospital
city: Gondar
country: Ethiopia
facility: Gondar University Hospital
Study officials:
affiliation: Institute of Tropical Medicine
name: Johan van Griensven, MD,PhD
role: STUDY_DIRECTOR
References:
citation: van Henten S, Tesfaye AB, Abdela SG, Tilahun F, Fikre H, Buyze J, Kassa M, Cnops L, Pareyn M, Mohammed R, Vogt F, Diro E, van Griensven J. Miltefosine for the treatment of cutaneous leishmaniasis-A pilot study from Ethiopia. PLoS Negl Trop Dis. 2021 May 28;15(5):e0009460. doi: 10.1371/journal.pntd.0009460. eCollection 2021 May.
Clinical trial NCT01162954: Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Local Tolerability After Administration of Eye Drop DA-6034 in Healthy Volunteers(Phase I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndrome
Keywords: Eye drop, Dry eye
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-07-15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial. The study is designed to evaluate the safety and local tolerability of DA-6034 upon single and repeated-dose topical application to the both eyes in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* 20-50 year-old healthy subjects

Exclusion Criteria:

* Presence or history of dry eye or other ocular or systemic diseases
* Corrected visual acuity less than 20/40 in either eye at the screening
* Any eye surgery or laser eye surgery within the past six months
* Intraocular pressure greater than 22 mmHg in either eye at the screening
* Break-up time less than 10 sec with OSDI score corresponding to mild to severe dry eye symptoms in either eye at the screening
* Unanesthetized Schirmer scores \<10 mm in either eye at the screening

Primary outcomes:
measure: Ocular symptomatology, ophthalmologic tests
timeFrame: Single dose: up to 5 days, Multiple dose: up to 15 days
Secondary outcomes:
measure: Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests
timeFrame: Single dose: up to 10 days, Multiple dose: up to 20 days
Other outcomes:
Locations:
city: Seoul, Chongno-Gu, Yon-Gon Dong 28
country: Korea, Republic of
facility: Clinical Research Institue, Seoul National University Hospital
Study officials:
affiliation: Clinical Research Institute, Seoul National University Hospital
name: Kyung-Sang Yu, M.D., Ph.D., M.B.A
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05234554: The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis
Official title: The INVIGORATE 2 Trial: A Single-center, Randomized, Double-masked, Crossover Design, Vehicle-controlled, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The INVIGORATE 2 Trial: A single-center, randomized, double-masked, crossover design, vehicle-controlled, Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (EEC).


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age at the time of screening of either sex or any race;
* Provide written informed consent;
* Be willing and able to follow instructions, and can attend all required clinical trial visits.
* Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement;
* Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).

Exclusion Criteria:

* Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
* Have systemic signs of infection (e.g., fever, current treatment with antibiotics).
* Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
* Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception;
* Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.

Primary outcomes:
measure: Ocular itching evaluated by the Subject.
timeFrame: During EEC allergen exposure.
Secondary outcomes:
measure: Conjunctival redness evaluated by the Subject.
timeFrame: During EEC allergen exposure.
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cliantha Research
state: Ontario
Study officials:
References:
Clinical trial NCT02919254: Beetroot Juice Doses and Anaerobic Performance
Official title: Evaluation of Various Doses of Beetroot Juice on Anaerobic Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaerobic Exercise
Dietary Supplementations
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the effect of varying nitrate doses of beetroot juice supplementation on dynamic, multijoint resistance exercise performance in active, trained individuals. Performance will be assessed based on parameters including neuromuscular efficiency, anaerobic performance capability, oxygen consumption, plasma nitrate/nitrite levels, specific muscle tissue biomarkers including lactate, and anthropometric measurements of select muscle groups.


Eligibility criteria: Inclusion Criteria:

* Minimum 6 consecutive months experience in resistance training, engaging at least 2 times per week.
* Possess sufficient mobility to properly execute movements required in testing protocol

Exclusion Criteria:

* Usage of any banned dietary supplements or performance enhancing drugs (thermogenics, anabolic steroids, prohormones, etc.)
* Any physical condition or malady that would impede participant from performing exercise or by doing so, endanger the individual

Primary outcomes:
measure: Muscle activation and fiber recruitment
timeFrame: 5 weeks
Secondary outcomes:
measure: Plasma nitrate/nitrite levels
timeFrame: 5 weeks
measure: Number of repetitions performed
timeFrame: 5 weeks
measure: Oxygen consumption
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
References: