louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04201574: Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Official title: A Phase 1/2a, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Exploratory Activity of Two Concentrations of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Allysta Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-12-17
Enrollment: 138
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: Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease

Detailed description: This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.

Eligibility criteria: Inclusion Criteria:

* Dry eye disease for \> 3 months meeting specific sign and symptom criteria
* Best correct visual acuity of +0.6 logMAR or better
* Willing to sign informed consent and attend study visits
* Willing to comply with contraception requirements

Exclusion Criteria:

* Unable to meet specific sign and symptom criteria
* Signs of ophthalmic allergic, inflammatory or infectious conditions
* Use of contact lenses
* Anatomic abnormalities preventing accurate study assessments
* Use of medications that influence eye dryness
* Recent ophthalmic surgery
* Unwilling to suspend current treatments for dry eye disease

Primary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: 8 weeks
measure: Eye Dryness Score (7-Day Average)
timeFrame: 8 weeks
measure: Corneal Fluorescein Staining
timeFrame: 8 weeks
Secondary outcomes:
measure: Ocular Discomfort Score by Visual Analog Scale
timeFrame: 8 weeks
measure: Symptom Assessment in Dry Eye (SAnDE) Score Assessment
timeFrame: 8 weeks
measure: Conjunctival Lissamine Green Staining
timeFrame: 8 weeks
measure: Conjunctival Hyperemia Grading
timeFrame: 8 weeks
measure: Tear Film Break-up Time (TBUT)
timeFrame: 8 weeks
measure: Schirmer's Test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Allysta Pharmaceuticals
state: Washington
Study officials:
affiliation: Allysta Pharmaceutical
name: Henry Hsu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04904874: Intense Pulsed Light Therapy in Meibomian Gland Dysfunction
Official title: Intense Pulsed Light Therapy in the Treatment of Refractory Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Dar Al Shifa Hospital
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: to evaluate the effect of intense pulsed light on resistant patients with Meibomian gland dysfunction


Eligibility criteria: Inclusion Criteria:

* age of at least 20 years.
* The diagnosis of obstructive MGD based on ocular symptoms, plugged gland oriﬁces, vascularity and irregularity of lid margins, and reduced meibum expression (meibum grade of .1, where grade 0 = clear meibum easily expressed, grade 1 = cloudy meibum expressed with mild pressure, grade 2 = cloudy meibum expressed with more than moderate pressure, and grade 3 = meibum could not be expressed even with strong pressure).
* failure of at least 3 types of conventional MGD therapy to improve symptoms or objective ﬁndings for at least 1 year before study treatment

Exclusion Criteria:

* the presence of active skin lesions, skin cancer, or other speciﬁc skin pathology.
* active ocular infection or ocular inﬂammatory disease.

Primary outcomes:
measure: Tear film break up time (TBUT)
timeFrame: 6 months
measure: schirmmer staining
timeFrame: 6 months
measure: Standard Patient Evaluation of Eye Dryness (SPEED)questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Dar alshif hospital
Study officials:
References:
Clinical trial NCT02801474: Surgical Management of Posterior Malleolar Fractures Using the Direct or Indirect Reduction Techniques
Official title: Surgical Management of Posterior Malleolar Fractures Using the Direct or Indirect Reduction Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Malleolus Fractures
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with a posterior malleolar fracture were recruited and assigned to the direct reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation of the fracture, the quality of fracture reduction was evaluated in radiograph and CT images. Functional outcome was evaluated at the last follow-up.

Detailed description: Patients with a posterior malleolus fracture were recruited meeting the inclusion criteria of unstable and displaced posterior malleolar fractures requiring surgical management. Patients with open fractures or pathological fractures were excluded. Preoperative anteroposterior (AP), lateral, and mortise view radiographs as well as computed tomography (CT) scans were routinely obtained to evaluate the characteristic of the fracture. Patients were then assigned to the direct reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation of the fracture using the direct reduction technique or the indirect reduction technique, the quality of fracture reduction was evaluated in radiograph and CT images. Functional outcome,including AOFAS score, ankle range of motion were evaluated at the last follow-up.

Eligibility criteria: Inclusion Criteria:

* unstable ankle fracture requiring surgical intervention
* with posterior malleolar fracture

Exclusion Criteria:

* open fractures
* pathological fractures

Primary outcomes:
measure: American Orthopaedic Foot and Ankle Society ankle-hindfoot score
timeFrame: 1 year
Secondary outcomes:
measure: ankle range of motion in degrees
timeFrame: 1 year
measure: residual displacement of the posterior malleolus in mm
timeFrame: 3 days postoperatively
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Jin XIONG, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi HF, Xiong J, Chen YX, Wang JF, Qiu XS, Huang J, Gui XY, Wen SY, Wang YH. Comparison of the direct and indirect reduction techniques during the surgical management of posterior malleolar fractures. BMC Musculoskelet Disord. 2017 Mar 14;18(1):109. doi: 10.1186/s12891-017-1475-7.
Clinical trial NCT05732974: A Machine Learning Approach to Identify Patients With Resected Non-small-cell Lung Cancer With High Risk of Relapse
Official title: A Machine Learning Approach to Identify Patients With Resected Non-small-cell Lung Cancer With High Risk of Relapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer Stage IIIA
Keywords: Machine-learning
Resected early stage Non-small Cell Lung Cancer
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an early stage of non small cell lung cancer with an indication of surgical resection

Brief summary: Early-stage non small cell lung cancer represents 20-30% of all non small cell lung cancer and is characterized by a high survival probability after surgical resection. However, considering stage IA-IIIA non small cell lung cancer, a relapse rate of about 50% is observed, with a different survival probability on the basis of tumor node metastasis status, although patients within the same tumor node metastasis stage exhibit wide variations in recurrence rate. There are currently no validated prognostic biomarkers able to identify patients with a high risk of relapse.

Detailed description: This study will use data from an already available cohort of patients enrolled in the Resting study (a project funded by TRANSCAN in 2018) as a training set and data from a new concurrent cohort as validation set.

Eligibility criteria: Inclusion Criteria:

* Patient with an early stage of non small cell lung cancer
* Indication of surgical resection
* Patient able to understand and give his consent
* Patient affiliated to the health insurance

Exclusion Criteria:

* Patient with another cancer in the last 5 years
* Patient with an allergy to the contrast medium
* Patient under legal protection

Primary outcomes:
measure: Algorithm for disease free survival
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Julien MAZIERES
Study officials:
affiliation: University Hospital, Toulouse
name: Julien MAZIERES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02186574: Tenofovir to Prevent HBV Reactivation
Official title: A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis B
Lymphoma
Non-Hodgkin
Keywords: Non-Hodgkin
Lymphoma
Hepatitis B
Tenofovir
Viread
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 184
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 purpose of the study is to determine how effective preemptive tenofovir therapy is in preventing the re-activation of Hepatitis B infection, in patients who are receiving rituximab-based chemotherapy for Non-Hodgkin's Lymphoma or CLL/SLL. The rate of re-activation will be compared between patients who receive preemptive tenofovir and patients who receive tenofovir as needed.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age
2. Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy
3. HBsAg negative, anti-HBc positive

Exclusion Criteria:

1. Current therapy with known activity against HBV
2. Screening ALT \> 10 x ULN
3. Screening ALT \>2 and \<10 xULN with HBV DNA \> 2000 IU/mL (indicates active HBV infection despite HBsAg negative and require antiviral therapy)
4. Life expectancy \< 3 months
5. HBsAg positive
6. HIV co-infection
7. Active HCV co-infection (HCV RNA positive)
8. Creatinine clearance \<50 mL/min
9. Intolerance to tenofovir
10. Women of child-bearing potential unwilling to take contraception during the study period

Primary outcomes:
measure: Rate of reverse seroconversion
timeFrame: 12 months post-chemotherapy
Secondary outcomes:
measure: Rates of HBV Reactivation
timeFrame: 12 months post-chemotherapy
measure: Severe HBV-associated hepatitis
timeFrame: 12 months post-chemotherapy
measure: HBV-related liver failure
timeFrame: 12 months post-chemotherapy
measure: Liver-related death
timeFrame: 12 months post-chemotherapy
measure: Treatment-related adverse effects (AEs)
timeFrame: 12 months post-chemotherapy
measure: Time to start chemotherapy
timeFrame: 12 months post-chemotherapy
measure: Chemotherapy interruption
timeFrame: 12 months post-chemotherapy
measure: All-cause mortality
timeFrame: 12 months post-chemotherapy
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Harry Janssen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04306874: Whipple Protein Study
Official title: High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Malnutrition
Keywords: pancreaticoduodenectomy
surgery
nutrition
protein
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, non-blinded, randomized controlled two-arm trial: supplement vs. placebo
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery

Detailed description: Pancreaticoduodenectomy (PD) is a complex and morbid operation that is associated with many potential complications. Many people undergoing PD are malnourished due to their underlying medical condition or difficulties eating in the face of abdominal pain or obstruction from pancreatic disease. This study aims to assess the effect of high-protein dietary supplementation in improving perioperative nutrition and decreasing complications. We will randomize PD patients to an experimental arm in which they take a nutritional, high-protein supplement for 2 weeks before and after surgery, or to a control arm, where they will take a standard postoperative diet without supplementation. Outcomes and nutritional parameters will be examined after they complete the supplements.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing pancreaticoduodenectomy
* Patients aged 18 years and older
* Patients able to provide written informed consent
* Patients able to understand and comply with study guidelines
* Patients able to tolerate oral intake
* Patients who are malnourished or at risk of malnutrition as defined by a score less than 12 on the Mini-Nutritional Assessment

Exclusion Criteria:

* Patients with a milk protein allergy
* Patients with a vegan diet
* Patients dependent on artificial enteral feeding
* Patients with end-stage renal disease undergoing dialysis
* Patients who are pregnant
* Patients with ongoing eating disorder or condition precluding oral intake
* Patients who are scheduled for pancreaticoduodenectomy but are unable to receive this surgery

Primary outcomes:
measure: Complications
timeFrame: 30 days
Secondary outcomes:
measure: Overall Survival
timeFrame: 6 months
measure: Prealbumin level
timeFrame: 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Associate Professor
name: Harish Lavu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03425474: Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
Official title: A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Diagnostic Upper GI Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing diagnostic upper GI endoscopy.

Detailed description: This is a multi-center, ,parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

Eligibility criteria: Inclusion Criteria:

* subjects aged 18-60 years；
* intending to undergo diagnostic upper GI endoscopy;
* ASA( American Society of Anesthesiologists) I or II；
* 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m²;
* the operation time of gastroscopy is not more than 30 min；
* Signed informed consent.

Exclusion Criteria:

* Patients need to be Complicated gastroscopy;
* Patients need to be Tracheal intubation;
* Patients with respiratory management difficulties (Modified Mallampati grade IV）;
* one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
* A history of drug abuse and / or alcohol abuse 2 years prior to the screening period；
* allergic to drugs used in the study;
* pregnant women or those in lactation period
* The subject has participated in other clinical trial within the 3 months prior to randomization.

Primary outcomes:
measure: rate of successful sedation
timeFrame: approximately 3 hours
Secondary outcomes:
measure: Sedation induction time
timeFrame: approximately 3 hours
measure: Sedation recovery time
timeFrame: approximately 3 hours
measure: rate of hypotension
timeFrame: approximately 3 hours
measure: rate of respiratory depression
timeFrame: approximately 3 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Clinical trial Ethnics Committee of Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04754074: Diet, Food, Exercise and Nutrition During Social Distancing
Official title: Diet, Food, Exercise and Nutrition During Social Distancing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Lifestyle
Sleep
Mood
Healthy Eating
Keywords: Behavior
Nutrition
Physical activity
Diet
Exercise
Social Distancing
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Our long-term goal is to contribute to the development of evidence-based nutritional and physical activity recommendations for the prevention and management of overweight and obesity and related chronic diseases.

The overall objective for this study is to determine if a 20-week educational program, project DFEND, related to behavior change and health will improve nutrition and physical activity outcomes as well as indicators of wellbeing.

Our central hypothesis is that regular attendance of weekly lectures, weekly meetings with personalized coaches, and weekly health challenges via virtual platforms (e.g. Zoom, Facebook, YouTube) will improve health outcomes related to nutrition and physical activity.

Our rationale for these studies is that the results of this research will enhance the potential to develop evidence-based nutritional and physical activity behavioral recommendations to treat and/or prevent development of overweight and obesity.


Eligibility criteria: Inclusion Criteria:

* Resides in Arkansas
* All ethnicities
* Female and male

Exclusion Criteria:

* None

Primary outcomes:
measure: Behavior change
timeFrame: 20 weeks
Secondary outcomes:
measure: Sleep
timeFrame: 20 weeks
measure: Mood
timeFrame: 20 weeks
measure: Physical Activity
timeFrame: 20 weeks
measure: Dietary Intake
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jamie Baum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04907474: Evaluation of Pupil Dilation Speed With the MAP Dispenser
Official title: A Study Evaluating Pupil Dilation Speed With the Micro-Array Print (MAP) Dispenser Comparing 2 Dosing Regimens of Tropicamide-Phenylephrine Fixed Combination Ophthalmic Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mydriasis
Lead sponsor: Eyenovia Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects received both treatments. Subjects were randomized to treatment order
Primary purpose: DIAGNOSTIC

Brief summary: 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation

Detailed description: After screening, eligible subjects will be scheduled for 2 treatment visits where either 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan. Safety evaluations and efficacy measurements will be performed at specified time intervals thereafter.

Pupil dilation for each treatment will be compared at each time interval.

Eligibility criteria: Inclusion Criteria:

1. Photopic screening pupil diameter ≤ 3.5 mm in each eye

Exclusion Criteria:

1. Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.
2. Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.
3. History of closed-angle glaucoma.
4. Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye).
5. Ocular surgery or laser treatment of any kind prior to the Screening Visit.
6. History of iris trauma, surgery, or atrophy.
7. Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.

Primary outcomes:
measure: Mean Change in Pupil Diameter From Baseline
timeFrame: 35 minutes post drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: CODET Vision Institute
state: Baja California
Study officials:
affiliation: Eyenovia Inc.
name: Tsontcho Ianchulev, MD, MPH
role: STUDY_DIRECTOR
References: