louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01763372: Functional Implications of Arthroscopic Iliopsoas Release
Official title: Functional Implications of Arthroscopic Iliopsoas Release
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroscopic Iliopsoas Release
Keywords: Arthroscopic
Iliopsoas
MRI
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing arthroscopic surgery by Dr. Aoki, divided into two groups:

Those undergoing arthroscopic psoas release, and those undergoing arthroscopic surgery without psoas release,

Brief summary: The purpose of this study is to investigate the functional effects of arthroscopic iliopsoas release. To complete this aim, we will recruit patients who have undergone arthroscopic iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as their own control. To delineate the effects of arthroscopic surgery alone from those resulting from iliopsoas release in addition to arthroscopic surgery, we will recruit a second control group consisting of patients who have undergone arthroscopic surgery by Dr. Aoki without iliopsoas release.

For both hips of each subject, we will:

* Quantify the muscle volume of the iliopsoas muscle with MRI.
* Quantify hip flexion strength with isokinetic dynamometry.
* Quantify patient function and satisfaction with functional outcome surveys.

This data will allow us to test the following hypotheses:

* Compared to the non-operative hip, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength.
* Compared to hips undergoing arthroscopic surgery without iliopsoas release, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength.
* Patient function and satisfaction positively correlates to muscle bulk and strength.


Eligibility criteria: Inclusion Criteria:

* All subjects will be greater than 18 years of age.
* We will recruit 18 subjects who have undergone arthroscopic iliopsoas release by Dr. Aoki.
* We will recruit 18 additional subjects that had hip arthroscopy with Dr. Aoki without iliopsoas release to serve as a control group.

Exclusion Criteria:

* As the nonoperative contralateral hip will serve as a control to the operative hip, we will exclude patients for this study who have undergone bilateral procedures.
* We will exclude any patients who are not comfortable with the MRI scan, stationary bike or strength testing.

Primary outcomes:
measure: Muscle Volume
timeFrame: 1 yr post op
Secondary outcomes:
measure: Hip Flexion Strength
timeFrame: 1 yr post op
Other outcomes:
Locations:
Study officials:
affiliation: Orthopedic Surgery Operations
name: Stephen Aoki
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00263172: Weight Loss on the Web: A Pilot Study Comparing a Commercial Website to a Structured Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diet Therapy
Weight Loss
Keywords: internet
weight management
behavior therapy
self-help
commercial program
obesity
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2005-12-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study was to compare weight loss achieved through a behavioral online intervention vs. a commercial self-help website. The investigators hypothesized that there would be no difference in weight loss between groups.

Detailed description: Obesity has reached epidemic proportions in the United States. Novel approaches are needed to address this issue on a broad scale. The internet holds promise as a way to disseminate effective weight loss strategies. The primary purpose of this study was to compare weight loss achieved through a behavioral online intervention vs. a commercial self-help website. A second aim was to evaluate the utilization of web components and their relationship to weight loss between groups and within groups in order to determine what aspects of web usage correlate to weight loss.

Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 39.9 kg/m2
* 18 or older

Exclusion Criteria:

* Planned to move within 1 year
* Planned a pregnancy within 1 year
* Take medications with weight implications
* Unable to exercise moderately
* Participating in another weight loss program
* Lacked minimum computer requirements

Primary outcomes:
measure: weight change
Secondary outcomes:
measure: social influence components
measure: eating behavior
measure: web usage correlation to weight change
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Behavioral Weight Management Program/Univ of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Doris E Ogden, MS, LCMHC
role: STUDY_DIRECTOR
References:
Clinical trial NCT01339572: Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation
Official title: Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Multiple Myeloma
Keywords: autologous transplantation
peripheral stem cell mobilization
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

Detailed description: Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.

Eligibility criteria: Inclusion Criteria:

* Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization.
* Karnofsky Performance Status ≥ 70.
* Age ≥ 18
* Less than 30% involvement of marrow with disease.

Exclusion Criteria:

* \> 30% marrow involvement with disease
* Age \< 18.
* Pregnant women.

Primary outcomes:
measure: Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers
timeFrame: Day 2 of apheresis
Secondary outcomes:
measure: Economic impact
timeFrame: Day 2 of mobilization and Day +100 after transplantation
measure: Kinetics of CD34+ mobilization with early introduction of plerixafor
timeFrame: On Day 1 and Day 2 of apheresis
measure: Graft composition
timeFrame: On Day 1 and Day 2 of apheresis
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Cancer Hospital at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jack W Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05395572: The Effects of Kinesio® Tape on Neck Pain and Disability
Official title: The Effects of Kinesio® Tape on Neck Pain and Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: North Dakota State University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study is a within-subjects design; therefore, the participant will serve as their own control. Participants will be included in the study if they have neck pain or disability defined by a score of more than 14 on the Neck Disability Index. They will be excluded if they have any diagnosed disc pathology. A mask-associated pain questionnaire will be completed by the participants prior to the study to determine their perceived effect of mask-wearing on neck pain. This questionnaire is adapted from the HAPPE study on mask-associated headache pain. A baseline pain rating will be recorded a numerical pain scale. Next, active cervical range of motion will be measured, three times in each direction to be averaged. A pain rating will be recorded for pain during cervical motion. Kinesio® Tape will be applied to activate the cervical extensor muscles. The participant will sit with the tape on for 20 minutes, then active cervical range of motion and pain will be recored again.


Eligibility criteria: Inclusion Criteria:

* Neck Disability Index Score of more than 14

Exclusion Criteria:

* cervical disc pathology or injury
* previous neck surgery
* prior history of general medical conditions involving joints, muscles, bones or connective tissue such as fibromyalgia, osteoporosis, etc.
* an NDI score of less than 14 or more than 24
* reported allergies to Kinesio® Tex Tape or any other adhesive material
* any contraindications for the usage of Kinesio® Tape

Primary outcomes:
measure: Neck Disability Index
timeFrame: 1 day
measure: Headaches Associated With Personal Protective Equipment
timeFrame: 1 day
measure: Dartfish
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: North Dakota State University
state: North Dakota
Study officials:
References:
Clinical trial NCT06864572: [68Ga]Ga-P17-079 in the Diagnosis and Treatment of Metastatic Prostate Cancer
Official title: Clinical Application of Dual-target Imaging Agent [68Ga]Ga-P17-079 in the Diagnosis and Treatment of Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Metastatic Prostate Cancer (mPC)
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Preclinical studies have confirmed that \[68Ga\]Ga-P17-079 in both mouse prostate tumors and osseogenic metastases has high uptake and prolonged retention, which enables \[68Ga\]Ga-P17-079 to be fully absorbed by the lesions, and it is possible to detect bone metastases, prostate cancer primary sites, lymph node metastases and organ metastases at the same time in a single examination. It is a potential "killing two birds with one stone" imaging agent. At this stage, the clinical study of \[68Ga\]Ga-P17-079 in the diagnosis and treatment of metastatic prostate cancer as a self-made preparation is planned to be carried out in our hospital to further verify its clinical application value.


Eligibility criteria: Inclusion Criteria:

* Male aged 18-85 years, expected survival ≥12 weeks.
* Patients who have not undergone chemoradiotherapy, feasible surgery or biopsy to obtain a pathological diagnosis or are highly suspected of malignancy according to clinical diagnostic criteria.
* At least one measurable target lesion was present according to RECIST1.1 criteria.
* Obtain written informed consent and be able to follow up

Exclusion Criteria:

* Severe abnormal liver and kidney function
* Fertile subjects will need to use effective contraception during the study
* Unable to lie flat for half an hour
* Refused to join this clinical investigator
* Suffering from claustrophobia or other mental illness
* Other conditions deemed unsuitable for participation in the trial

Primary outcomes:
measure: SUV
timeFrame: 0-180 min post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT00902772: Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users
Official title: A Single-Centre, Single-Dose, Double-Blind, Randomized, Placebo- and Active-Controlled Crossover Study to Evaluate the AbusePotential of AZD7325 in Healthy Recreational CNS Depressant Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recreational CNS Depressant Use
Keywords: Recreational CNS depressant
Abuse liability
Abuse potential
Healthy Recreational CNS Depressant Users
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to examine the abuse potential of AZD7325.


Eligibility criteria: Inclusion Criteria:

* Recreational CNS depressant use, defined as at least 10 lifetime occasions of non-medical use of drugs with depressant/sedative properties and at least 1 non-medical use in the year prior to screening
* Body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening
* Willing and able to abide by all study requirements and restrictions

Exclusion Criteria:

* Unwillingness of inability to abstain from recreational drug use for the duration of the study from screening until follow-up
* Positive breath alcohol test prior to dosing
* Clinically significant abnormalities on physical examination, medical history, 12-lead ECG, vital signs, or safety laboratories

Primary outcomes:
measure: Visual Analog Scales
timeFrame: Daily during Visit 2 through 9
Secondary outcomes:
measure: Columbia Suicide-Severity Rating Scale
timeFrame: Prior to each treatment period
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: Kendle Early Stage - Toronto
name: Myroslava K Romach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06694272: Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration
Official title: Functional and Anatomical Visual Investigations in Patients With Early Forms of Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age Related Macular Degeneration
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2024-11-19
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: subjects with early or intermediate AMD (normal visual acuity)

Brief summary: Age-related macular degeneration (AMD) is the leading cause of visual impairment in industrialized countries. Anatomical examination findings at the early and intermediate stages of AMD are not sufficient to determine any functional alterations at these stages (e.g., alterations in microperimetry, multifocal electroretinogram (mfERG) and contrast sensitivity). Identifying early functional markers of the disease is a necessary first step in the development and clinical validation of treatments to slow progression to advanced disease.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Corrected visual acuity 10/10 in each eye
* Presence of retinal alteration(s) compatible with early (presence of macular drusen \< 125 μm) or intermediate (macular drusen \> 125 μm or pigmentary abnormalities) AMD in at least one of the two eyes :

  * Conventional "soft" or "hard" drusen
  * Cuticular drusen
  * Reticulated pseudo-drusen

Exclusion Criteria:

* Presence of geographic atrophy, even incipient, in one or both eyes
* Presence of patent or latent neovascularization visible on OCT b-scan or OCT-A in one or both eyes
* Compatibility of retinal signs with a "probable" differential diagnosis (bestrophinopathies, familial drusen, fundus flavimaculatus, fundus albipunctatus, hypovitaminosis A) in one or both eyes.
* Oculomotor pathology that may prevent proper performance of functional tests: nystagmus, oculomotor paralysis, in one or both eyes
* Neurological/neurodegenerative pathology that may prevent adequate performance of functional tests: advanced Parkinsonian syndromes, Benson's disease, Alzheimer's disease with visuomotor apraxia
* Other ophthalmological pathology that may affect anatomical and functional measurements: hypertonia / glaucoma or other optic neuropathy, media disorder causing reduced visual acuity, refraction \< -6.00D or \> +6.00D
* Other medical conditions preventing examinations or imaging (tremors, etc.)

Primary outcomes:
measure: AMD evolution at 4 years
timeFrame: Year 4
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschild
Study officials:
References:
Clinical trial NCT06826872: Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Phase 2(2b) Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hypertension, Essential
Cardiovascular Diseases
Cardiology
Keywords: blood pressure
Low-dose combination therapy
candesartan
amlodipine
indapamide
Lead sponsor: Shin Poong Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 252
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: - Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. Additionally, it seeks to confirm the contribution of each component at low doses.

- Inclusion Criteria: Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.

- Exclusion Criteria: Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.

- Methods: This study is a multicenter, randomized, double-blind, parallel-group, phase 2b clinical trial to evaluate the safety and efficacy of the investigational drug after 8 weeks of administration.

Screening assessments will be conducted within 4 weeks prior to randomization, and patients who meet the inclusion and exclusion criteria at the screening visit will be enrolled in the study after providing informed consent. These participants will undergo a 2-week run-in period during which they will take a placebo and participate in a lifestyle modification program.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.

Exclusion Criteria:

* Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.

Primary outcomes:
measure: The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8.
timeFrame: Change from Baseline in MSSBP at Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea
Study officials:
References:
Clinical trial NCT01729572: Measuring the Effect of Remote Monitoring of Treatment Adherence on the Risk of Re-admission of Ambulatory Schizophrenic Patients
Official title: The Effect of add-on Tele Medicine Monitoring of Medication Adherence, on the Risk of Re-hospitalisation of Ambulatory Schizophrenic Patients. an Open, Prospective, Randomised Controled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
Schizoaffective Disorder
disease management
treatment
rehabilitation
pharmacotherapy
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: SHL Telemedicine Ltd.
First posted: 2012-11-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse.

Detailed description: Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse. The study is an uni center, open, prospective, randomised and controlled.

Eligibility criteria: Inclusion Criteria:

* DSM 4 diagnosis of schizophrenia or schizoaffective
* able to give written informed consent
* Have a telephone line

Exclusion Criteria:

* Are not discharged to a place with routine medication monitoring
* Are not discharged under forced ambulatory treatment order
* Are not homeless
* Are not admitted due to drug intoxication or withdrawal.
* Are not admitted due to severe self harm.

Primary outcomes:
measure: Time to re-hospitalisation
timeFrame: 1 year
Secondary outcomes:
measure: number of re-hospitalisations
timeFrame: 1 year
Other outcomes:
measure: Total time in hospital
timeFrame: 1 year
Locations:
city: Hod-Hasharon
country: Israel
facility: Shalvata MHC
Study officials:
References: