louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06701721: A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
Official title: A Phase 1b Open-Label, Multiple Ascending Dose Study of the Safety, Tolerability, and Biological Activity of Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diabetic Macular Edema
Diabetic Retinopathy
Keywords: Diabetic Macular Oedema
Non-proliferative Diabetic Retinopathy
Lead sponsor: Therini Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Multiple Ascending Dose
Primary purpose: TREATMENT

Brief summary: THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.

Detailed description: This is an open label, multiple ascending dose (MAD) study, in which the safety of THN391 will be assessed in escalating doses. This study will enroll a total of approximately 21 participants into 3 sequential dose-escalating cohorts. Participants will receive 3 monthly THN391administrations.

Eligibility criteria: Inclusion Criteria:

* Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
* 18 to 80 years of age (inclusive at the time of informed consent).
* Diagnosis of Diabetic Macular Edema (DME)
* Vision loss in the study eye

Exclusion Criteria:

* Be pregnant or breastfeeding
* Cataract surgery or any other previous ocular surgery in the study eye within 3 months before Screening
* Any other condition except for DME that could affect interpretation of study assessments

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 16 weeks following first dose administration
Secondary outcomes:
measure: Change in Visual Acuity
timeFrame: Up to 16 weeks following first dose administration
measure: Change in Retinal Edema
timeFrame: Up to 16 weeks following first dose administration
Other outcomes:
Locations:
city: Parramatta
country: Australia
facility: Marsden Eye Specialists
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: Therini Bio, Inc.
name: Joel Naor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06787521: Patient Empowerment and Agency Through Intrapartum Counseling and Education
Official title: PEAICE: Patient Empowerment and Agency Through Intrapartum Counseling and Education: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: Intrapartum
Labor Agency
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization will be done using REDCap.
Primary purpose: OTHER

Brief summary: A single-blind randomized controlled trial to study the effects of a labor guide on perceived control in labor. The experimental arm will receive an evidence-based labor guide at the time of admission for scheduled induction of labor. The control arm will receive the standard of care in-person counseling regarding options for labor interventions

Detailed description: Participants will be randomized to receive an evidence-based labor guide at the time of admission for scheduled induction of labor, or the standard of care. Following delivery, patients will be surveyed about their labor experience. Chart review will be done to collect data on obstetric interventions and outcomes and neonatal outcomes.

Eligibility criteria: Inclusion Criteria:

* Nulliparous
* Singleton pregnancy
* English-speaking
* Undergoing induction of labor for a medical or elective indication
* Reached at least 36 weeks 0 days gestation
* Willing and able to sign a consent form
* Delivering at OHSU

Exclusion Criteria:

* Undergoing induction termination
* Fetal complications such as multiple gestation, major fetal anomalies, fetal demise
* Decisionally-impaired adults
* Minors

Primary outcomes:
measure: Labor Agentry Scale-10 (LAS-10)
timeFrame: 1-7 days following delivery
Secondary outcomes:
measure: Labor Interventions
timeFrame: During labor
measure: Maternal hyper/hypotension
timeFrame: During induction of labor
measure: Intrapartum blood loss
timeFrame: Labor and delivery
measure: Cesarean section
timeFrame: Delivery
measure: Time to delivery
timeFrame: Admission for induction to delivery
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Fei Cai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543621: An Intervention Program to Control Diabetes
Official title: An Intervention Program to Control Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to evaluate the effectiveness of a structured intervention to improve diabetes control.


Eligibility criteria: Inclusion Criteria:

* informed consent
* 18-70 adults
* Type 2 Diabetes
* Males and non-pregnant females

Exclusion Criteria:

* Use of exogenous insulin for glucose control
* Use of medications or supplements for weight loss
* Advanced diabetes complications
* Recent history of cardiovascular event

Primary outcomes:
measure: HbA1c, Fasting blood glucose,blood pressure, weight loss
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huandong Hospital
Study officials:
affiliation: Clinical Nutrition Center, Huadong Hospital
name: Jianqin Sun, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06432621: Role of Sugammadex and Neostigmine for Recovery From Rocuronium
Official title: Sugammadex Versus Neostigmine for Recovery of Respiratory Muscle Strength Measured by Ultrasonography in the Postextubation Period in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: evaluation the reversal of neuromuscular blocking by sugammadex versus neostigmine through assessing the residual neuromuscular blocking effect by ultrasound imaging of expiratory muscle strength and diaphragmatic excursion.

Detailed description: All patients will be assessed preoperatively by careful history taking (history of allergy to rocuronium, neostigmine, or sugammadex), full medical history taking , ASA classification and surgical history Premedication with 2mg midazolam. Anesthesia will be induced with propofol 1-2 mg /kg and fentanyl 1-2 mic/kg. After calibration of TOF (train of four) rocuronium 0.6 mg/kg will be administered, and tracheal intubation will be performed in the absence of train-of four (TOF) count. Rocuronium 0.15mg/kg and Sevoflurane will be used for maintenance of anesthesia.

At the end of the surgery, patients in group A will receive sugammadex (2 mg/kg) and patients in group B will receive neostigmine (50 μg/kg, maximum 5 mg) combined with atropine (25 μg/kg, maximum 2.5 mg) after TOF counts at least exceeding 1 and extubation will be performed in the operating room when the patient is fully awake and fulfilled clinical criteria for extubation.

Diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography.

Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiology (ASA) physical status classification I and II

Exclusion Criteria:

* 1. American Society of Anesthesiology (ASA) physical status classification III-V 2. renal impairment 3. Significant liver disease (Child-Pugh B or C class) 4. History of chronic obstructive pulmonary disease 5. Known or suspected neuromuscular disease. 6. Cardiac arrhythmia or use of antiarrhythmic drugs.

Primary outcomes:
measure: effect of sugammadex and neostigmine on reversal of rocuronium
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
Study officials:
References:
Clinical trial NCT03911921: RSYR for Fatigue Reduction in Cancer Survivors
Official title: Renshen Yangrong Tang (RSYRT) for Reducing Fatigue in Cancer Survivors: A Phase II Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer-related Problem/Condition
Keywords: Fatigue, Cancer
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized Phase II trial
Primary purpose: TREATMENT

Brief summary: This randomized Phase II trial to establish the efficacy of traditional Chinese medicine (TCM) herbal products above control group for treating fatigue in patients with cancer.

Detailed description: Patients who were randomized and been enrolled in, had stable disease and no anemia, and reported moderate to severe fatigue over two months (rated ≥4 on a 0-10 scale). Patients took TCM decoction Renshen Yangrong decoction (RSYR),Which containing 12 TCM herbs, twice a day for 6 weeks. RSYRT aims to correct Qi deficiency. Fatigue was assessed before and after RSYRT therapy.

Eligibility criteria: Inclusion Criteria:

Pathological diagnosis of malignant tumors; 3 months without surgery, radiotherapy and chemotherapy, biological treatment; Hemoglobin \> 11g/L; Complete remission of the lesion, or recent review of the Disease is stable, the estimated survival time is more than 6 months; ECOG score is 0-2, fatigue score of the last 24 hours \> 4 ; Age is 18-65 years old; TCM syndrome differentiation for deficiency of qi; Liver, kidney function, electrolyte normal; Willing to join the group and sign the informed consent.

Exclusion Criteria:

Allergies to herbs and plant drugs; Uncontrollable diabetes, hypertension, TSH abnormalities, uncontrollable pain, and a history of myocardial infarction within 6 months; Scores of anxiety disorders and depression (HAD-D) were 11 or more, antidepressants and antioxidants were used in the past month; Breast cancer receptor positive patients took endocrine therapy drugs; Tonics were used in the past 2 weeks.; Children, pregnant and lactating women; Receiving anemia-related treatment; Chinese medicine syndrome differentiation with excessive heat; Unable to read or understand the scale.

Primary outcomes:
measure: Fatigue score
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Pingping Li, Prof.
role: STUDY_DIRECTOR
affiliation: Peking University Cancer Hospital & Institute
name: Ting Lu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu Y, Wang XS, Chen Y, Shi Q, Chen TH, Li P. A Phase II Randomized Controlled Trial of Renshen Yangrong Tang Herbal Extract Granules for Fatigue Reduction in Cancer Survivors. J Pain Symptom Manage. 2020 May;59(5):966-973. doi: 10.1016/j.jpainsymman.2019.10.018. Epub 2019 Oct 24.
Clinical trial NCT03637621: Retrospective Analysis on Distal Humerus Fractures
Official title: Distal Humerus Fractures: A Data Analysis on Patients Undergoing Open Reduction and Internal Fixation for the Surgical Management of Distal Humeral Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Distal Humerus Fracture
Lead sponsor: The Orthopaedic Research & Innovation Foundation
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients of the names principal investigator receiving open reduction and internal fixation of the distal humerus for any indication at St. Elizabeth Healthcare on or after January 1, 2010 will be evaluated and included in the data analysis.

Brief summary: The purpose of this study is to evaluate preoperative objective measurements for distal humerus ORIF patients and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

1. English speaking
2. \>18 years of age
3. Open reduction internal fixation surgical management of a distal humeral fracture performed by principal investigator at St. Elizabeth Healthcare

Exclusion Criteria:

1. Non-English speaking
2. \<18 years of age

Primary outcomes:
measure: total operative time
timeFrame: preoperative to up to 8 years postoperative
measure: amount of blood loss
timeFrame: preoperative to up to 8 years postoperative
Secondary outcomes:
measure: Patient Outcomes
timeFrame: preoperative to up to 8 years postoperative
measure: Patient Outcomes
timeFrame: preoperative to up to 8 years postoperative
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: The Orthopaedic Research & Innovation Foundation
state: Kentucky
Study officials:
affiliation: The Orthopaedic Research & Innovation Foundation
name: R M Greiwe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01357421: Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
Official title: A Phase 1 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effects of a Single Intravenous Dose of TT301 on LPS-induced Changes in Blood Cytokine Levels in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Traumatic Brain Injury
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

Detailed description: The LPS human endotoxemia model results in a well characterized, transient acute inflammatory response. The model has been widely used for decades as a system to study new therapeutic agents for inflammation before wider clinical studies are undertaken. This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

Eligibility criteria: Inclusion Criteria:

* Male
* 18 to 40 years, inclusive
* 55 - 95 kg, inclusive

Exclusion Criteria:

* Evidence of any clinically significant disease
* History of cancer
* History of syncope or severe vasovagal events
* Antibiotic treatment within 60 days of Day 1
* Surgical procedure within 60 days of Day 1
* Hepatitis C, Hepatitis B
* Tuberculosis
* HIV
* Requirement for medications (prescription/OTC) during the study
* Donated \> 250 mL blood within 30 days of Day 1
* Donated \> 750 mL blood within 60 days of Day 1
* In a clinical trial of an immunosuppressive drug within 6 months of Day 1
* Received any vaccination within 6 months of Day 1
* Any clinically important allergy
* Known allergy/sensitivity to lactose and/or polyethylene glycol

Primary outcomes:
measure: Cytokine levels post LPS challenge
timeFrame: Measured up to 12h post-LPS
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Unit
state: North Carolina
Study officials:
affiliation: Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc.
name: Laura Agensky, BSc, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT01492621: Effect of Antidepressants on White Matter Structure
Official title: White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depression
Keywords: major depression
DTI
inflammatory markers
cognition
Lead sponsor: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-12-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects with major depression will be evaluated and intensively characterized through questionnaires, computerized cognitive evaluation and laboratory investigations. Magnetic resonance imaging will be used to document baseline white matter structure. subjects will then receive desvenlafaxine which will be adjusted as clinically indicated. After 16 weeks the evaluations will be repeated.

Detailed description: 40 subjects will be included in the study. Diagnosis will be confirmed by MINI. Participants will be characterised using questionnaires, pain threshold, cognition, facial expression recording and MRI. Desvenlafaxine will be initiated at 50mg AM. At week 8 Desvenlafaxine may be increased to 100mg as clinically indicated. Measures will be repeated at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Major depression
* Age 18 to 55
* Hamilton grater or equal to 20

Exclusion Criteria:

* Major neurologic disorder
* Major cardiovascular disorder
* Unstable medical condition
* Significant psychiatric co-morbidity
* Current substance dependance
* Pregnancy or lactation -Treatment resistance as defined by nonresponse to 2 or more antidepressant treatments (adequate dose and duration) -

Primary outcomes:
measure: Anisotropy
timeFrame: 16 weeks
Secondary outcomes:
measure: cognitive measures
timeFrame: 16 weeks
measure: Pain threshold
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre de Recherche Fernand-Seguin
state: Quebec
Study officials:
affiliation: University of Montreal, Centre de recherche Fernand Seguin
name: Smadar V Tourjman, MDCM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04083521: Effect of Bacillus Subtilis DE111® on Daily Bowel Movements
Official title: The Effect of Bacillus Subtilis DE111® on the Daily Bowel Movement Profile for People With Occasional Gastrointestinal Irregularity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Movement Regulation
Occasional Constipation
Occasional Diarrhea
Keywords: Bowel movement regulation
Occasional constipation
Occasional diarrhea
Gastrointestinal health
Lead sponsor: Deerland Enzymes
Sponsor class: INDUSTRY
Collaborators: name: Kennesaw State University
First posted: 2019-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the efficacy of Bacillus subtilis DE111® probiotic for regulation of bowel movements.

Detailed description: The purpose of this study is to determine the efficacy of the probiotic B. subtilis DE111® for regulation of bowel movements. A single capsule containing 1 x 10\^9 CFU B. subtilis is to be consumed once a day per participant. 50 adults (18-65 years of age at the time of participation) suffering from occasional constipation and/or diarrhea will be enrolled. Participants will be double-blindly and randomly assigned to either the probiotic (Bacillus subtilis) or the placebo (maltodextrin) group. Efficacy will be assessed with participant-reported bowel movement (BM) records. As a secondary outcome, the study will provide further insight into the tolerance of the supplement. Tolerance will be assessed using a digestive health questionnaire and blood samples to analyze pertinent metabolic biomarkers. Participants will be asked to complete a daily dietary intake record as well. Prior to capsule consumption, participants will complete a two-week pre-testing phase in order to provide a more inclusive diagnostic baseline. This phase will consist of daily BM and dietary intake record keeping.

Eligibility criteria: Inclusion Criteria:

* Participants suffering from occasional constipation and/or diarrhea will be eligible for participation.

Exclusion Criteria:

* Blood CRP levels for each participant will be monitored at days 0, 60 and 105 of this study. Participants with CRP levels greater than 5mg/l on day 0 of the study will be excluded from further participation as this level is indicative of underlying inflammatory bowel disease. Participants excluded under such conditions will be instructed to seek further treatment with their health care provider.

Primary outcomes:
measure: Bowel movement regularity
timeFrame: 105-day study period (consisting of 90-days treatment plus 15-day follow up)
measure: Tolerance
timeFrame: 105-day study period (consisting of 90-days treatment plus 15-day follow up)
Secondary outcomes:
Other outcomes:
Locations:
city: Kennesaw
country: United States
facility: Kennesaw State University
state: Georgia
Study officials:
References: