louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05655377: FitMi PD Home Therapy for Parkinson's Disease
Official title: FitMi PD: an Affordable Home Therapy Device for Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Flint Rehabilitation Devices, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Southern California
First posted: 2022-12-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The investigators will run an at-home usability study of a newly developed home exercise device (FitMi PD) for individuals with Parkinson's disease. FitMi PD uses embedded sensors that can track and record the user's direction and degree of movement while performing exercises described on a computer.


Eligibility criteria: Inclusion Criteria:

* mild to moderate PD (Hoehn and Yahr stage I to III)
* Mini-Mental State Examination greater than 28

Exclusion Criteria:

* Age less than 18 years old

Primary outcomes:
measure: Number of Participants That Successfully Used FitMi PD to Exercise at Home
timeFrame: Immediately Post-Treatment, an average of 3 weeks
Secondary outcomes:
measure: Mini Mental State Examination (MMSE)
timeFrame: Baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
Clinical trial NCT00446277: Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery
Official title: Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Diabetes Mellitus
Keywords: cataract surgery, endothelial cell, cell loss, diabetes
mellitus type II
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2007-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE

Brief summary: The aim of the present study is to evaluate changes in the morphology and function of the corneal endothelium before and after cataract surgery in patients with diabetes type II. Also to explain if determination of HgbA1c in diabetics is a predictor for the changes in morphology and function.

Detailed description: Thirty patients with Diabetes type II and thirty non-diabetes patients scheduled to cataract surgery (phacoemulsification with intraocular lens implantation) were invited to participate in the study. Preoperatively, all patients had a full eye examination and 3 endothelial cell photos were taken.

Three months postoperatively the patients were called for a re-examination including 3 endothelial cell photos. The function of the cornea is dependent of the number and morphology of the endothelial cells, and even small traumas like cataract surgery may disrupt the cornea integrity leading to corneal haze and blur. Diabetics may be more vulnerable to corneal stress.

Eligibility criteria: Inclusion Criteria:

* Patients with cataract scheduled for surgery

Exclusion Criteria:

* Patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.

Primary outcomes:
measure: corneal endothelial cell count (cells / mm2)
measure: percentage of hexagonal cells
measure: variation in cell size
measure: central corneal thickness
Secondary outcomes:
measure: visual acuity
measure: intraocular pressure
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Ophthalmology, Frederiksberg University Hospital
state: Copenhagen
Study officials:
affiliation: Frederiksberg University Hospital
name: Allan Storr-Paulsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02790177: Role of Hyaluronic Acid in the Prevention of Post-operative Adhesions: a RCT
Official title: Is Hyaluronic Acid Effective in the Prevention of Post-operative Adhesion?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post Operative Adhesions
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2016-06-03
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of study is to determine the effect of hyaluronic acid on the formation of post-operative adhesions. It will be a randomized control trial comparing the product against normal saline.


Eligibility criteria: Inclusion Criteria:

- All consenting patients between the ages of 12-80, who undergo exploratory laparotomy and stoma formation

Exclusion Criteria:

Previous history of abdominal surgery History of peritoneal dialysis Patients in whom permanent stoma is formed

-

Primary outcomes:
measure: POST OPERATIVE ADHESIONS TO BE EVALUATED BY LAPAROSCOPY AT THREE MONTHS INTERVAL
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00915577: Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe
Official title: An Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
interferon beta-1a
Avonex
liquid Avonex
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER

Brief summary: Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.


Eligibility criteria: Inclusion Criteria:

* Must be using liquid AVONEX® to treat MS. In addition, the subject must be on liquid AVONEX® for 12 weeks prior to the Screening Visit.
* Must have a BMI of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at Screening.
* Must be able to physically demonstrate use of the device and be able to self-administer all injections.
* Must be English speaking.
* Must be able to understand and comply with the protocol.

Exclusion Criteria:

* Abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (WBC) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (ALT) aspartate transaminase (AST), prothrombin time (PT).
* Known sensitivity to dry natural rubber.
* Treatment with other agents to treat MS symptoms or underlying disease as specified in the protocol.
* History of severe allergic or anaphylactic reactions.
* History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
* Serious local infection

Other inclusion and exclusion criteria apply as per Biogen Idec Protocol

Primary outcomes:
measure: The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe
timeFrame: The study duration is 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Biogen-Idec Investigator
role: STUDY_DIRECTOR
References:
Clinical trial NCT06898177: Development and Testing of a Mobile App to Scale Delivery of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder
Official title: Development and Testing of a Mobile App to Scale Delivery of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Avoidant/restrictive food intake disorder (ARFID) is a serious and impairing eating disorder - occurring in up to 4% of adults - for which most individuals do not have access to treatment. The proposed study aims to develop and test a mobile app to scale delivery of cognitive-behavioral therapy for ARFID. Knowledge gained will contribute to the development of a clinically accessible, scalable, inexpensive treatment for ARFID, a highly impairing disorder for which there are significant barriers to care access.


Eligibility criteria: Inclusion Criteria:

1. Current avoidant/restrictive food intake disorder based on DSM-5 criteria
2. Must not have completed face-to-face CBT-AR at the Eating Disorders Clinical and Research Program at Massachusetts General Hospital
3. Ability to speak, write, and understand English
4. Residence in the United States
5. Access to an internet-connected smartphone device

Exclusion Criteria:

1. Underweight status (i.e., BMI \< 18.5 kg/m2)
2. Complete lack of oral intake or dependence on supplemental feeding
3. Feeding or eating disorder other than ARFID
4. Any comorbid clinically significant disorder that would require attention beyond the study treatment

6. Medical instability requiring inpatient care according to the American Psychiatric Association 2023 treatment guidelines for eating disorders 7. Medical history of intellectual disability 8. Illiteracy

Primary outcomes:
measure: Pica, ARFID, and Rumination Disorder Interview - ARFID Questionnaire (PARDI-AR-Q)
timeFrame: Change from baseline (assessed at study entry) to final session, which occurs an average of eight weeks after baseline (measured at weekly study treatment sessions)
measure: Food Neophobia Scale (FNS)
timeFrame: Change from baseline (assessed at study entry) to final session, which occurs an average of eight weeks after baseline (measured at weekly study treatment sessions)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00196677: Study of Glaucoma Treatment With Food Additives
Official title: Treatment of Glaucomatous Neuropathy With Food Additives
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Glaucomatous Neuropathy
Lead sponsor: Future Products Management
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if certain food additives are effective in the treatment of glaucoma, improving and reversing the progress of the disease.

Detailed description: Glaucomatous neuropathy is a condition that worsens with time causing atrophy of the optic nerve and narrowing of the visual field which may culminate in blindness. The treatment tested in the trial employs certain food additives intended to reverse this pathology.

Eligibility criteria: Inclusion Criteria:

* Stable open angle glaucoma - with equilibrated eye internal pressure
* Above the age of 50 years and have severe damage that does not progress to the vision field in the upper and lower half. Scoring of the vision field will be made according to the Agis study instructions.

Exclusion Criteria:

* Eye diseases excluding past cataract operation
* Allergy to one of the components in the preparation
* Deterioration in the vision field in the last year
* Kidney diseases, gastrointestinal (G.I.) tract, liver diseases, coagulation problems and thyroid diseases
* Persons who take steroids
* Diabetics or unbalanced hyperglycemia
* Autoimmune diseases
* Hypertension (not responding to treatment)
* Psychiatric treatment with drugs, psychiatric pathologies
* Pregnancy
* Ability to take more than 3 pills per day regularly
* Smoking

Primary outcomes:
measure: Improvement in vision field (Protocol24) in a Humphrey's instrument. Scoring according to the Agis study
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Future Products Management
name: Meir Gorban, MD
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Hani Levkovitch-Verbin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01755377: New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease
Official title: Evolution of Serologic Biomarkers and Diastolic Function and Segmentary Contractility Determined by Echocardiography After Treatment in Chagas Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas Disease
Lead sponsor: Barcelona Centre for International Health Research
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migrants from Latin America visiting the Tropical Medicin Clinic

Brief summary: Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.


Eligibility criteria: Inclusion Criteria:

* Patients from endemic areas (Latin America)
* Older than 18 years old and younger than 50
* With serological confirmation of Chagas Disease infection with two different techniques
* Indeterminate or initial cardiac form
* No previously treated for Chagas Disease

Exclusion Criteria:

* Co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent. Hepatic disfunction
* Pregnancy or lactation

Primary outcomes:
measure: Biomarkers for prognosis, early diagnosis and effectiveness of treatment.
timeFrame: 2 years
Secondary outcomes:
measure: Cardiac function after antiparasitic treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: International Health Department, Hospital Clinic, Barcelona
state: Cataluña
Study officials:
affiliation: Barcelona Centre for International Health Research (CRESIB)
name: Joaquim Gascón, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516.
Clinical trial NCT03150277: Post - Activation Potentiation After Plyometric and Heavy Resistance Exercise in Soccer Players
Official title: Post - Activation Potentiation Following Acute Bouts of Plyometric Versus Heavy Resistance Exercise in Collegiate Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soccer
Lead sponsor: Jamia Millia Islamia
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover design
Primary purpose: OTHER

Brief summary: The main purpose of this study will be comparison of acute effects of plyometric and heavy resistance exercise on post-activation potentiation

Detailed description: This is a single-center, randomized, crossover study. Collegiate soccer players will be enrolled in this study. The study will be performed in 3 separate sessions.In the first session, participants will be familiarized with the experimental conditions and 1RM will be calculated. Participants will then be randomized to receive either heavy resistance or plyometric exercise first in the second session and then will be crossed over to receive the opposite intervention in the third session. The objective of the study is to compare the acute effects of plyometric and heavy resistance exercise on post - activation potentiation by measuring physical performance and blood lactate level.

Eligibility criteria: Inclusion Criteria:

* Collegiate soccer players aged 18 - 26 years
* Participants must have at least 2 years of playing experience
* Participants should be involved in sport-specific training on at least 2 occasions per week and play competitively once per week

Exclusion Criteria:

* Lower extremity reconstructive surgery in last 24 months or unresolved musculoskeletal disorder which would prohibit subject to participate in the sport.
* Participants who are consuming (or had consumed) growth hormone, anabolic steroids or any kind of performance enhancing drugs.

Primary outcomes:
measure: Blood lactate level
timeFrame: Measured prior to and after the intervention period (at 1 minute and 10 minute)
Secondary outcomes:
measure: Countermovement jump height
timeFrame: Measured prior to and after the intervention period (at 1 minute and 10 minute)
measure: 20 m single sprint time
timeFrame: Measured prior to and after the intervention period (at 1 minute and 10 minute)
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sports Complex, Jamia Millia Islamia
state: Delhi
Study officials:
affiliation: Jamia Millia Islamia
name: Shahid Raza, MPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma SK, Raza S, Moiz JA, Verma S, Naqvi IH, Anwer S, Alghadir AH. Postactivation Potentiation Following Acute Bouts of Plyometric versus Heavy-Resistance Exercise in Collegiate Soccer Players. Biomed Res Int. 2018 Feb 7;2018:3719039. doi: 10.1155/2018/3719039. eCollection 2018.
Clinical trial NCT03471377: Improving Planned Surgical Case Duration Accuracy by Leveraging the EHR and Predictive Modeling
Official title: Improving Planned Surgical Case Duration Accuracy by Leveraging the EHR and Predictive Modeling - A Randomized Control Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Operative Time
Keywords: Planned Surgical Case
Predictive Modeling
18-115
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 683
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgeons and OR staff from the GYN and CRS services

Brief summary: The investigators are studying the duration it takes surgeons to complete their respective surgical cases. The hospital hopes to improve the overall operating room scheduling accuracy from this project.


Eligibility criteria: Inclusion Criteria:

* A surgeon or OR staff member in the Department of Surgery Gynecology and Colorectal service

Exclusion Criteria:

* Any new surgeon that starts their practice during the study
* Surgery will take place at a location other than the Main hospital or Josie Robertson Surgical Center
* Cases where input data was not available prior to the prediction generation including late add-on cases such as urgent and emergent cases that are placed on the schedule less than 24 hours before the surgery

Primary outcomes:
measure: duration it takes surgeons to complete their respective surgical cases
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memoral Sloan Kettering Basking Ridge
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christopher Stromblad
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stromblad CT, Baxter-King RG, Meisami A, Yee SJ, Levine MR, Ostrovsky A, Stein D, Iasonos A, Weiser MR, Garcia-Aguilar J, Abu-Rustum NR, Wilson RS. Effect of a Predictive Model on Planned Surgical Duration Accuracy, Patient Wait Time, and Use of Presurgical Resources: A Randomized Clinical Trial. JAMA Surg. 2021 Apr 1;156(4):315-321. doi: 10.1001/jamasurg.2020.6361.
Clinical trial NCT02714777: General Anesthesia and Autonomic Nervous System in Children
Official title: General Anesthesia and Autonomic Nervous System in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Keywords: General anesthesia
Autonomic nervous system
Children
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 4 to 8 years enjoying a scheduled surgery without any infection or trauma context and performed under general anesthesia

Brief summary: The objective of the ANESPEDIA study is to describe in a pediatric population (aged from 4 to 8 years old) receiving elective surgery, the impact of general anesthesia on autonomic nervous system and their kinetics of early postoperative course (24 hours).

Detailed description: Some physiological factors such as sport activity or pathological as sepsis, certain chronic diseases or diabetes are known to modulate the overall autonomic activity and the intrinsic capacity of the individual to regulate its sympathovagal balance. These influences can alter the physiological autonomic balance sometimes with positive consequences on the Cardiac frequency-breathing control, blood pressure adjustment depending on the position of the individual, on the status of blood volume, but sometimes deleterious with bad regulation of sinus cardiac activity and respiration rate.

General anesthesia is recognized as one of the factors that can modify more or less sustainable the sympathovagal autonomic balance. While many studies described the effects of anesthesia on the autonomic nervous system, most data are done in adult subjects. For the child who sees intrinsically autonomic physiological changes related to its maturative status, assessment of the impact of anesthesia in the pediatric population in per and postoperative was never realized.

Eligibility criteria: Inclusion Criteria:

* Post-anesthesia Monitoring in pediatric intensive care units or Pediatric Surgery Hospital North of Saint Etienne.
* Compendium of the form signed by the holder of parental authority

Exclusion Criteria:

* Child with pathologies reaching the central nervous system or the brain stem.
* Children with a severe pathology of cardio-respiratory or heart being referred to treatment.
* Children requiring emergency surgery or trauma or septic or inflammatory context

Primary outcomes:
measure: Description of parasympathetic activity evolution by heart rate variability
timeFrame: 24 hours
Secondary outcomes:
measure: Heart rate variability (HRV)
timeFrame: 24 hours
measure: Heart rate variability (HRV)
timeFrame: at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 Hours
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hugues PATURAL, PhD
role: PRINCIPAL_INVESTIGATOR
References: