louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06378164: The Effect of Combined Volitional and Reactive Step Training in Reducing Falls Risk in Older Fallers
Official title: The Immediate and Sustained Effect of 4-week Combined Volitional and Reactive Step Training in Reducing Falls Risk in Community-Dwelling Older Fallers: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Older Adults With a History of Falls
Keywords: Falls
Exercise
Randomised Trial
Step Training
Reaction
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: Neuroscience Research Australia
name: The University of New South Wales
First posted: 2024-04-22
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling
* Able to walk for 1 minute under supervision without walking aids
* Have a history of falling in the past year

Exclusion Criteria:

* Cognitive impairment (i.e., scores below the age and education-specific cut-off of 7th percentile in the 5-minute Montreal cognitive assessment)
* Blindness
* Neurological conditions (e.g., stroke, Parkinson's disease)
* Other serious illnesses that preclude participation in exercise training

Primary outcomes:
measure: Choice Stepping Reaction Times
timeFrame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
measure: Spring Scale Test
timeFrame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Secondary outcomes:
measure: Mini Balance Evaluation System Test
timeFrame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
measure: Motor Control Test
timeFrame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
measure: Falls Efficacy Scale - International
timeFrame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
measure: Trail-Making Test
timeFrame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
measure: Programme Adherence
timeFrame: From start to six months after the end of training
measure: Prospective Falls
timeFrame: From start to 12 months after the intervention ends
measure: Adverse Events
timeFrame: From start to six months after the end of training
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Freddy Man Hin LAM, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04027764: Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer
Official title: Toripalimab Combined With S1 and Albumin Paclitaxel as First Line in Patients With Advanced Biliary Tract Cancer: a Single-arm,One Center， Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Biliary Tract Cancer
Keywords: advanced biliary tract cancer
Albumin Paclitaxel
s1
Toripalimab
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigator's study is a single armed phrase II trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of Toripalimab combining with S1 and Albumin Paclitaxel as first line in patients with advanced Biliary Tract Cancer. treatment continually until disease progression or intolerable toxicity or Patients withdrawal of consent.and target sample is 30+ patients.

Detailed description: Toripalimab: 240 mg , once every 2-3 weeks; S1: 80-120mg, bid; oral, day1-14; Albumin paclitaxel: 120mg/m2 , administered on the first day and the eighth day of each cycle; 21 days for a treatment cycle

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology
3. Liver function Child-Pugh grade A (5-6 points) or better grade B (≤ 7 points)
4. ECOG score 0 or 1 point
5. At least one measurable lesion
6. no previous treatment

Exclusion Criteria:

1. organs failure ,including liver ,heart ,kidney
2. Have received a liver transplant in the past
3. Active brain metastasis or spinal cord compression
4. ECOG score 3 or 4 point
5. Symptomatic peripheral neuropathy (CTCAE ≥ 2)

Primary outcomes:
measure: objective response rate
timeFrame: 1 year
Secondary outcomes:
measure: progression free survival
timeFrame: 1 year
measure: disease response rate
timeFrame: 1 year
measure: overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01692964: Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysfunctional Tear Syndrome
Keywords: Dry Eye
Lead sponsor: RapidPS
Sponsor class: UNKNOWN
First posted: 2012-09-26
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study.

Brief summary: InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.

Detailed description: The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month:

  1. Burning or stinging
  2. Sandy or gritty feeling
  3. Foreign body sensation
  4. Tearing
  5. Light sensitivity
  6. Intermittent or fluctuating vision
  7. Tired eyes

Exclusion Criteria

* Allergy to cornstarch or Dacron
* Allergy to topical anesthetic or fluorescein dye
* Prior eye injury, trauma, or ocular surgery within the last 3 months
* Known blockage of the lacrimal drainage system
* Contact lens wear in the last month
* Previous corneal refractive surgery including RK, LASIK or PRK surgery
* Have an active ocular infection or history of a recent ocular infection in the last month
* Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis
* Use of oral doxycycline, corticosteroids, or immunomodulators in the last month
* Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, or topical ocular cyclosporine in the last month
* Pregnant or lactating
* Use of any topical ophthalmic medications, including artificial tears 2 hours prior to enrollment

Primary outcomes:
measure: Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Manatee-Sarasota Eye Clinic
state: Florida
city: Springfield
country: United States
facility: Mercy Clinic - Eye Specialists
state: Missouri
city: Johnson City
country: United States
facility: Ophthalmic Associates
state: New York
city: El Paso
country: United States
facility: Ophthalmology Diagnostics & Clinical Research
state: Texas
Study officials:
References:
citation: Sambursky R, Davitt WF 3rd, Friedberg M, Tauber S. Prospective, multicenter, clinical evaluation of point-of-care matrix metalloproteinase-9 test for confirming dry eye disease. Cornea. 2014 Aug;33(8):812-8. doi: 10.1097/ICO.0000000000000175.
Clinical trial NCT06197464: FLOAT Through Anxiety: Virtual Reality Application's Efficacy as a Tool to Distract From Negative Emotions and Thoughts
Official title: FLOAT Through Anxiety: Examining the Efficacy and Safety of the Virtual Reality Application "Float" as a Tool to Distract From Negative Emotions and Thoughts in People With High Levels of Anxiety and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Control
Experimental
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to examine the effectiveness and safety of the VR FLOAT application as a tool to reduce negative thoughts and feelings and anxiety symptoms in students with high levels of stress and anxiety. The main questions it aims to answer are:

1. Will subjects with high levels of anxiety who will use the FLOAT application experience a more significant relief in feelings of anxiety compared to subjects in the control group?
2. Will subjects who are used to using technology find greater comfort in using VR compared to subjects who are not used to it?
3. What is the degree of satisfaction with the use of VR and are there any reports of side effects?Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets Researchers will compare control group to see The comparison between using FLOAT as a regulation strategy after psychoeducation on emotional regulation and cognitive-behavioral use of a regulation strategy after the same psychoeducation


Eligibility criteria: Inclusion Criteria:

* 'moderate' or 'severe' levels of stress and/or anxiety according to the DASS-21 questionnaire
* student

Exclusion Criteria:

* under the age of 18
* diagnoses of schizophrenia or bipolar disorder, including past or present psychotic conditions
* suicidality
* pregnant women
* do not speak or read Hebrew fluently
* a diagnosis of epilepsy.

Primary outcomes:
measure: situational anxiety before session
timeFrame: a week
measure: situational anxiety after session
timeFrame: a week
measure: satisfaction with life
timeFrame: baseline
measure: satisfaction with life
timeFrame: week 3, after intervention
measure: Ease of using the technology
timeFrame: week 3, after intervention
Secondary outcomes:
measure: The FLOAT user experience
timeFrame: week 3, after intervention
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa
name: YAEL ENAV, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06879964: Usefulness of Post-Operative Radiotherapy in High-grade Cutaneous Squamous Cell Carcinoma: an Observational Study
Official title: Usefulness of Post-Operative Radiotherapy in High-grade Cutaneous Squamous Cell Carcinoma: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous Squamous Cell Carcinoma (CSCC)
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 120
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: patients with a diagnosis of high-grade cutaneous squamous cell carcinoma, eligible for post-operative radiotherapy, cared for at the Dermatologic Clinic, Fondazione IRCCS Policlinico San Matteo.

Brief summary: Post-operative radiotherapy (PORT) is currently considered as the second most important therapy to treat high-grade cutaneous squamous cell carcinoma. Nonetheless, only few studies evaluate its impact on recurrence rate and the major part of those ones do not include a proper control group of patients.

Most recent guide lines from NCCN, Sidemast and British associations of dermatologists suggest clinicians to offer or consider PORT in selected patients but class nor level of evidence of those guide lines are provided.

This project evaluates impact of post-operative radiotherapy on recurrence rate and overall survival by comparing two cohort of patients, the former who accepted PORT and the latter who, nonetheless its necessity, decided to not undergo it.

The hypothesis which this project will answer concerns the effectiveness of post-operative radiotherapy in preventing local and regional recurrences. We expect a significant decrease of recurrence rate in patients who undergo this therapeutic option as compared to those with clinical indication but do not undergo PORT.


Eligibility criteria: Inclusion Criteria:

* diagnosis of high-grade cutaneous squamous cell carcinoma
* patients eligible for post-operative radiotherapy
* minimum follow-up of 24 months

Exclusion Criteria:

* lack of clinical of histological data
* impossibility of a proper follow-up
* occurrence of intermediate events (i.e., pregnancy)

Primary outcomes:
measure: effectiveness of post-operative radiotherapy in preventing local and regional recurrences
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, SC Dermatologia
Study officials:
References:
Clinical trial NCT02573064: Impact of Treatment With Colistin on Mortality Bacteremia Multiresistant Acinetobacter Baumannii Sensitive Colistin in Patients Critical
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acinetobacter Infections
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 113
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical patients with monomicrobial bloodstream infections due to monoclonal antibodies were studied; specific criteria were applied for analysis of empirical therapy and targeted therapy (113 patients).

Brief summary: The present study was designed to study the impact of empirical treatment with colistin empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of bacteremia Multiresistant Acinetobacter Baumannii . The main objective was to evaluate the efficacy of empirical treatment with colistin and combined targeted therapy. The different therapeutical interventions were administered following the routine clinical practice in the medical centre and the investigator did not assign specific interventions to the subjects of the study.


Eligibility criteria: Inclusion Criteria:

* Critics included patients ≥ 16 years with monomicrobial bloodstream infections by multiresistant acinetobacter baumannii to carbapenems and sensitive to colistin accompanied by systemic inflammatory response syndrome, provided they have received targeted treatment with colistin.

Primary outcomes:
measure: All-cause 30-day mortality (crude).
timeFrame: 30 days
Secondary outcomes:
measure: All-cause 14 day mortality (crude).
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References:
citation: Amat T, Gutierrez-Pizarraya A, Machuca I, Gracia-Ahufinger I, Perez-Nadales E, Torre-Gimenez A, Garnacho-Montero J, Cisneros JM, Torre-Cisneros J. The combined use of tigecycline with high-dose colistin might not be associated with higher survival in critically ill patients with bacteraemia due to carbapenem-resistant Acinetobacter baumannii. Clin Microbiol Infect. 2018 Jun;24(6):630-634. doi: 10.1016/j.cmi.2017.09.016. Epub 2017 Sep 29.
Clinical trial NCT06207890: Exploring Clinical Study Experiences of People With Anorexia Nervosa
Official title: An Analysis of Participation Trends: Observing Patient Engagement in Anorexia Nervosa Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with anorexia nervosa who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.

Brief summary: The study seeks to delve into the firsthand experiences of patients diagnosed with anorexia nervosa who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future anorexia nervosa patients and play an active role in advancing medical research.


Eligibility criteria: Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with anorexia nervosa
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant

Primary outcomes:
measure: Number of patients who decide to participate in anorexia nervosa clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in anorexia nervosa clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Walsh BT, Hagan KE, Lockwood C. A systematic review comparing atypical anorexia nervosa and anorexia nervosa. Int J Eat Disord. 2023 Apr;56(4):798-820. doi: 10.1002/eat.23856. Epub 2022 Dec 12.
citation: Paolacci S, Kiani AK, Manara E, Beccari T, Ceccarini MR, Stuppia L, Chiurazzi P, Dalla Ragione L, Bertelli M. Genetic contributions to the etiology of anorexia nervosa: New perspectives in molecular diagnosis and treatment. Mol Genet Genomic Med. 2020 Jul;8(7):e1244. doi: 10.1002/mgg3.1244. Epub 2020 May 5.
citation: Parpia R, Spettigue W, Norris ML. Approach to anorexia nervosa and atypical anorexia nervosa in adolescents. Can Fam Physician. 2023 Jun;69(6):387-391. doi: 10.46747/cfp.6906387.
Clinical trial NCT06031090: Clonidine Versus Granisetron for Shivering Prevension
Official title: Intravenous Clonidine Versus Granisetron for Prevention of Post Spinal Anesthesia Shivering in Cesarean Section
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Post Spinal Anesthesia Shivering
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-09-11
Enrollment: 186
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption

Detailed description: Shivering is one of the most important periperative complications seen in clinical practice. Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition of thermoregulation resulting in hypothermia is an important cause of post anesthesia shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and serotonergic receptors also are involved of shivering.

Various drugs were studied for their potential role in prevention of peri-operative shivering such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine.

We decided to perform a well-designed study to compare clonidine and granisetron which has been recently introduced as drugs for prevention and control of shivering after spinal anesthesia.

Eligibility criteria: Inclusion Criteria: Patient acceptance.,Aged between 21-40 years old, BMI: 18- 30 kg/m2, ASA: I and II., Scheduled for elective cesarean section under spinal anesthesia.

-

Exclusion Criteria:

History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus

-

Primary outcomes:
measure: Incidence of Shivering
timeFrame: Procedure (through out the period of spinal anesthesia)
Secondary outcomes:
measure: core body temperature
timeFrame: Procedure (preoperative as base and through out the period of spinal anesthesia)
measure: Maternal Heart rate
timeFrame: Procedure (preoperative as base and through out the period of spinal anesthesia)
measure: baby APGAR score
timeFrame: 1 minutes and 5 minutes post natal
measure: maternal blood presure
timeFrame: Procedure (preoperative as base and through out the period of spinal anesthesia)
Other outcomes:
measure: maternal oxygen saturation
timeFrame: Procedure (preoperative as base and through out the period of spinal anesthesia)
Locations:
city: Zagazig
country: Egypt
facility: Heba M Fathi
Study officials:
References: