louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05504811: FitMi AD Home Therapy for Individuals with MCI or Mild Dementia Due to Alzheimer's Disease
Official title: FitMi AD: a Safe and Motivating Computer-guided Exercise System for Individuals with MCI or Mild Dementia Due to Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Dysfunction
Dementia, Mild
Lead sponsor: Flint Rehabilitation Devices, LLC
Sponsor class: INDUSTRY
Collaborators: name: Rancho Research Institute, Inc.
First posted: 2022-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy of a newly developed exercise device (FitMi AD) for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. FitMi AD uses embedded sensors that can track and record the patient's direction and degree of movement while performing exercises described on a computer.


Eligibility criteria: Inclusion Criteria:

* have MCI or mild dementia due to AD (i.e. Clinical Dementia Rating (CDR) score 1 for mild dementia or 0.5 for MCI)
* ability to clearly see the screen and hear the audio instructions from the tablet
* have a family member or friend who can answer questions about the participant's daily living skills
* willing to participate in a research study.

Exclusion Criteria:

* age \< 50 years old
* use of a wheelchair as a primary mobility device (use of a cane or walker is permitted)
* presence of other neurologic conditions such as movement disorders or history of stroke
* other severe concurrent medical conditions that may prevent the participants from completing the 3-month study

Primary outcomes:
measure: Change in Functional Reach Test
timeFrame: Baseline, Immediately Post-Treatment (an average of 3 months)
measure: Change in Timed Up and Go test
timeFrame: Baseline, Immediately Post-Treatment (an average of 3 months)
measure: Change in 30 second chair stand test
timeFrame: Baseline, Immediately Post-Treatment (an average of 3 months)
Secondary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Baseline, Immediately Post-Treatment (an average of 3 months)
measure: Global Physical Activity Questionnaire
timeFrame: Baseline, Immediately Post-Treatment (an average of 3 months)
measure: Geriatric Depression Scale
timeFrame: Baseline, Immediately Post-Treatment (an average of 3 months)
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, Immediately Post-Treatment (an average of 3 months)
measure: Duration of exercise performed
timeFrame: Immediately Post-Treatment (an average of 3 months)
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Research Institute, Inc
state: California
Study officials:
affiliation: Rancho Research Institute, Inc.
name: Freddi Segal-Gidan, PA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01122511: Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Subfoveal Choroidal Neovascularization
Age-Related Maculopathy
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration


Eligibility criteria: Inclusion Criteria:

* Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
* Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
* Visual acuity between 20/320 and 20/40

Exclusion Criteria:

* Active ocular infection
* Contraindication to pupil dilation in either eye
* Eye surgery including cataract surgery and/or laser of any type within 3 months

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography
timeFrame: Baseline, Month 12
measure: Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Fort Myers
country: United States
state: Florida
city: Abilene
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06985511: Assessment of Marginal Bone Loss and Anterior Implant Stability in Immediate Versus Early Implant Placement
Official title: Assessment of Marginal Bone Loss and Anterior Implant Stability in Immediate Versus Early Implant Placement: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marginal Bone Loss
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: split-mouth design
Primary purpose: TREATMENT

Brief summary: This study aims to determine the differences in implant stability and measurement of bone loss near implants between two different healing approaches used for teeth replacement in the front part of the upper jaw.


Eligibility criteria: Inclusion Criteria:

* Presence of unrestorable bilateral anterior teeth.
* Harmonious gingival contour and thick gingival phenotype
* Minimum 4 mm of apical bone and 2 mm of intact labial plate
* Absence of periapical pathology

Exclusion Criteria:

* Systemic conditions affecting osseointegration or healing
* Active oral infections or periodontal disease
* Dehiscence or fenestration defects
* Poor oral hygiene or heavy smoking

Primary outcomes:
measure: Marginal Bone Loss
timeFrame: up to 12 months
measure: Implant stability
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Beirut Arab University
Study officials:
References:
Clinical trial NCT03433911: FemBloc® Permanent Contraception - Early Pivotal Trial
Official title: BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Contraception
Keywords: Permanent contraception
Birth control
Lead sponsor: Femasys Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-15
Enrollment: 240
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study duration will be approximately 65 months. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.


Eligibility criteria: Inclusion Criteria:

* Female, 21 - 45 years of age desiring permanent birth control
* Sexually active with male partner
* For FemBloc Arm:

  * Regular menstrual cycle for last 3 months or on hormonal contraceptives
* For Control Arm:

  * Undergoing planned laparoscopic bilateral tubal sterilization

Exclusion Criteria:

* Uncertainty about the desire to end fertility
* Known or suspected pregnancy
* Prior tubal surgery, including sterilization attempt
* Prior endometrial ablation
* Presence, suspicion, or previous history of gynecologic malignancy
* Abnormal uterine bleeding requiring evaluation or treatment
* Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)

Primary outcomes:
measure: Incidence of short-term and long-term adverse events in each arm
timeFrame: 1-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: New Horizons Clinical Trials
state: Arizona
city: Stanford
country: United States
facility: Stanford University
state: California
city: Lake Worth
country: United States
facility: Altus Research Inc.
state: Florida
city: Idaho Falls
country: United States
facility: Rosemark Womencare Specialists
state: Idaho
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Newark
country: United States
facility: Rutgers, The State University of New Jersey
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Beachwood
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Mason
country: United States
facility: Amy Brenner MD & Associates
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga Medical Research LLC
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Medical Affairs & Clinical Development
name: Sponsor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01792011: Accuracy of the Pleth Variability Index to Predict Fluid Responsiveness in Liver Transplantation
Official title: Accuracy and Utility of the Pleth Variability Index as a Predictor of Fluid Responsiveness During the Dissection and Anhepatic Phase of Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamic Instability
Keywords: Elective living donor liver transplantation
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the accuracy of PVI (pleth variability index)

Detailed description: The aim of this study is to compare the accuracy of PVI (pleth variability index)with other hemodynamic variability that measured with PİCCO (SVV, PPV, CVP,CI)to predict the response of cardiac index to volume replacement in patients undergoing liver transplantation.

Eligibility criteria: Inclusion Criteria:

* Elective living donor liver transplantation,
* \>18 years patients

Exclusion Criteria:

Patients with:

* Arrhythmia
* Reduced left ventricular function (EF\<40%)
* Hepatocellular carcinoma
* Pulmonary hypertension
* Fulminant liver failure
* valvular heart disease

Primary outcomes:
measure: To test the ability of PVI to detect changes in preload during orthotopic liver transplantation
timeFrame: During dissection and anhepatic phase (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation
Study officials:
affiliation: Inonu University Faculty of Medicine Anesthesiology and Reanimation Department
name: Gulay Erdogan Kayhan, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT05196711: A Study to Evaluate the Safety of MAX-40070 in Healthy Subjects
Official title: A First-in-Human Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of MAX-40070 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Alopecia Areata
Lead sponsor: Maxinovel Pty., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a First-in-Human phase I study to evaluate the safety, tolerability and pharmacokinetic characteristics of MAX-40070 in Healthy SubjectThe study will be comprised of 2 parts; Part A and Part B. Part A will be conducted at NZCR, and Part B will be conducted at both NZCR and another site(s) in China (if required). Part A will include approximately 48 participants, and Part B will include approximately 30 participants.


Eligibility criteria: Inclusion Criteria:

* Weigh at least 50kg (females) or 55kg (males) and have a BMI between 20.0 kg/m2 - 30.0 kg/m2.
* Subjects having no ulceration, damage, sunburn, redness, rash, acne, folliculitis, pigmentation, uneven skin tone, excessive freckles on the skin of the target application area and fever.

Exclusion Criteria:

* An abnormality related to the comprehensive physical examination, laboratory test, 12-lead ECG, and other diagnostic tests and which is determined by the investigator as clinically significant (CS).
* A history of CS diseases of heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system.
* Intolerance to venipuncture for blood collection and/or having blood or needle phobia.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments
timeFrame: 36 Days
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: 1 Day
measure: Time at which Cmax was first observed (Tmax)
timeFrame: 1 Day
measure: Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)
timeFrame: 1 Day
measure: Area under the concentration curve for on dosing interval at steady state (AUC0-t)
timeFrame: 36 Days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03271411: Extension of EMDR vs. PC For Motor Vehicle Accident Trauma
Official title: Extension of EMDR vs. PC For Motor Vehicle Accident Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma, Psychological
Motor Vehicle Accident
Lead sponsor: Trauma Institute & Child Trauma Institute
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 20
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: This is an extension of a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. The purpose of this extension is to add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to see a) if that has any impact on participant retention, treatment effectiveness, or treatment efficiency; and b) if such impact is equivalent with EMDR and PC.


Eligibility criteria: Inclusion Criteria:

* adult reporting distress related to motor vehicle accident-related trauma
* English-speaking

Exclusion Criteria:

* already in therapy in which the memory of interest is being actively addressed with a structured/focused trauma resolution method
* any obvious/urgent need for more comprehensive psychotherapy (based on initial screening interview)
* any indication of instability during interactions prior to the therapy session
* an average score on the Dissociative Experiences Scale of 30 or greater, if (as per follow-up questions) indicating a likely dissociative disorder

Primary outcomes:
measure: Change in SUDS following treatment
timeFrame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
measure: Change in PRS following treatment
timeFrame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
measure: Change in PDS following treatment
timeFrame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Northampton
country: United States
facility: Trauma Institute & Child Trauma Institute
state: Massachusetts
Study officials:
affiliation: Trauma Institute & Child Trauma Institute
name: Ricky Greenwald, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05047211: Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
Official title: A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia, Iron Deficiency
Delivery Complication
Keywords: Postpartum, iron deficiency anemia, intravenous iron
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

Brief summary: This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients.

Two randomly assigned groups will be compared during the postpartum period:

1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID.

   IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.

2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.


Eligibility criteria: Inclusion Criteria:

* Delivery at our institution
* Hemoglobin below 9 g/dl in postpartum day 1
* Singleton gestation

Exclusion Criteria:

* Diagnosis of malabsorptive disorder or history of gastric bypass procedure
* Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)
* Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure
* Patient has received blood transfusion or there is a plan to transfuse
* Lactose intolerance

Primary outcomes:
measure: Hemoglobin Level
timeFrame: 6 weeks after delivery
Secondary outcomes:
measure: Number of Participants With Nausea or Vomiting
timeFrame: up to 6 weeks after delivery
measure: Myalgia
timeFrame: up to 6 weeks after delivery
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Ashley Salazar
state: Texas
Study officials:
References:
Clinical trial NCT01058811: Established Lung Cancer Cell Line and Stroma Cell From Surgical Tissue
Official title: Established Lung Cancer Cell Line and Stroma Cell From Surgical Tissue: Find Lung Cancer Stem Cells and Test Its Chemotherapy Drug Resistance; Compare Stroma Cell Between Tumor Part and Surrounding Part
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: lung cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
name: National Science and Technology Council, Taiwan
First posted: 2010-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lung cancer patient

Brief summary: Try to find lung cancer stem cells from primary culture of routine surgical resection of lung cancer tissue including cancer cells and stroma cells, then characterization the established cell lines, and compare the difference of stroma cells between tumor part and surrounding part.


Eligibility criteria: Inclusion Criteria:

* lung cancer patient with surgical resection of lung tumor

Exclusion Criteria:

* lung cancer patient without surgical resection of lung tumor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital, Taipei, Taiwan
name: Chao-Chi Ho, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03878511: Therapeutic Lactose to Support Vaginal Microbiota
Official title: Effect of Vaginal Lactose on the Vaginal Microbiota in Women With Bacterial Vaginosis: Double-blind, Placebo-controlled Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginoses
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to investigate whether the administration of a vaginal tablet containing lactose can modulate the bacterial flora of women with bacterial vaginosis (BV).

Design: Double-blind, placebo-controlled randomised trial.

Setting: Women with BV who responded to advertisements in local newspapers and on posters at the Institutions for Education in Health Science in Eastern Jutland, Denmark. These individuals were supplemented with patients enrolled at a gynaecological clinic.

Participants: Forty women with BV diagnosed through the Amsel test. By randomisation, 20 were assigned to receive lactose tablets, and 20 were assigned to receive placebo tablets.

Interventions: Twice daily application of one lactose tablet or placebo tablet for 7 days.


Eligibility criteria: Inclusion Criteria:

* Amsel criteria positive defined as 3/4 of the following: Vaginal discharge, Fishy odor, pH\>4.5 and Clue cells in a wet smear.

Exclusion Criteria:

* Not able to provide written informed consent.

Primary outcomes:
measure: Bacterial load after intervention
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: