louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01326351: Prolotherapy for the Treatment of Plantar Fasciitis
Official title: Plantar Fasciitis: Pain Relief and Improvement of Foot Function With Prolotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Plantar Fasciitis
Lead sponsor: Réseau de Santé Vitalité Health Network
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that prolotherapy in conjunction with a physiotherapy program looking at reinforcing calf muscle and muscle of the plantar fascia, relieves pain and improves function of people suffering of plantar fasciitis, an inflammation of the plantar fascia, after basic treatment failure.


Eligibility criteria: Inclusion Criteria:

* have a diagnosis of Plantar Fasciitis
* experience pain in the plantar fascia for more than 6 months
* be capable to understand and execute physiotherapy exercises

Exclusion Criteria:

* previous operation of the plantar fascia
* deformation of the foot (congenital or acquired)
* presence or suspicion of infection of the skin at the site where the injection will occur
* history of systemic diseases capable of inducing pain or sensitivity to the feet (seronegative arthritis, diabetes, fibromyalgia, etc.)
* abnormal coagulation
* allergy to lidocaine and/or marcaine
* pregnancy
* lumbar, hip or knee pain

Primary outcomes:
measure: Assessment of pain and function of the affected foot during the course of treatment
timeFrame: Every 3 weeks from week 0 to 36
Secondary outcomes:
measure: Assessment of pain intensity and pain-related function impairment during the course of treatment
timeFrame: Every 3 weeks from week 0 to 36
Other outcomes:
Locations:
city: Moncton
country: Canada
facility: Dr.-Georges-L.-Dumont University Hospital Centre
state: New Brunswick
Study officials:
References:
Clinical trial NCT06461351: Long-term Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection
Official title: A Long Term Follow-up Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: B-cell Tumors
Lead sponsor: Juventas Cell Therapy Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registered clinical trial patients with different indications and post market commercialized patients who have received treatment with Inaticabtagene Autoleucel Injection

Brief summary: This clinical trial adopts an observational research method to conduct annual follow-up and monitoring of patients receiving treatment with Inaticabtagene Autoleucel Injection after its commercialization, in order to evaluate the delayed adverse events of Inaticabtagene Autoleucel Injection.

Detailed description: Patients treated with Inaticabtagene Autoleucel Injection (including registered clinical trial patients with different indications of this product and commercialized patients after market launch), would be included in this program for a maximum of 15 years of long-term follow-up (LTFU), and an informed consent form must be signed again. The research period was 15 years after Inaticabtagene Autoleucel infusion. The patient was followed up once a year for 15 years.

Eligibility criteria: Inclusion Criteria:

1. Agree to sign an informed consent form for long-term follow-up studies.
2. Registered clinical trial patients with different indications for this product who have received at least one infusion of Inaticabtagene Autoleucel Injection in the past, as well as post market commercialized patients.

Exclusion Criteria:

- None.

Primary outcomes:
measure: Replication-competent lentivirus，RCL
timeFrame: once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years.
Secondary outcomes:
measure: Long-term Adverse Drug Reaction
timeFrame: once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, Tianjin, China
name: Jianxiang Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01633554: ST-2; a Non-invasive Fibrosis Marker for Chronic Hepatitis B
Official title: The Ability of Prediction of Fibrosis for ST-2 as a Non-invasive Marker in Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sequela of Chronic Liver Disease
Keywords: ST-2, IL-33, prediction, fibrosis, hepatitis B
Lead sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-07-04
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 Healthy Volunteers 45 patients with chronic hepatitis B 25 patients with liver cirrhosis

Brief summary: IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.

Detailed description: ST-2 is an IL-1 receptor family member and exists in both a membrane-bound isoform and a soluble (sST2) isoform. It has a functional ligand (Interleukin-33) and via ST-2/IL-33 inflammation and immunity is regulated. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic hepatitis B or liver cirrhosis

Exclusion Criteria:

* Accompanying chronic inflammatory disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Türkiye Yüksek İhtisas Education and research Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT00260754: Utilization of the Community Popular Opinion Leader (C-POL) Model in Alabama
Official title: Utilization of the Community Popular Opinion Leader (C-POL) Model to Achieve Syphilis Elimination in Alabama
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Sexually Transmitted Diseases
Keywords: Risk behavior
Sexually transmitted diseases
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of Alabama at Birmingham
First posted: 2005-12-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Community members within the treatment city will report: 1)engaging in fewer sexual risk practices; 2)significantly higher condom use; 3) significantly higher rates of STD care seeking (including STD screening behaviors); 4) fewer having STDs in the past 6 months; 5) significantly higher awareness scores regarding syphilis and other STDs, as compared with those in the comparison city.

Detailed description: The C-POL in Alabama project is and intervention study which sought to impact the health behaviors of community residents who live in zip codes that have high syphilis morbidity. The study is being implemented in Birmingham and Montgomery with shelter clients.

The intervention model used for this study is the Popular Opinion Leader (POL) model, which is effective at reducing new HIV infections. The intent of this study was to determine the effectiveness of a diffusion model (e.g. POL) at reducing syphilis infections in affected communities.

For the intervention, community members identified as popular opinion leaders were recruited and trained to share accurate information about syphilis transmission, symptoms, testing, treatment and prevention. Prior to intervention implementation and several times after, community members were given a survey and screened for syphilis as well as 2-3 additional STDs. During each assessment, cross-sections of the community members were sampled.

Eligibility criteria: Inclusion Criteria:

* Clients who utilized two community homeless shelters in the affected community. The affected community was one that had significant syphilis morbidity at the onset of the study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in syphilis morbidity in affected community
Secondary outcomes:
measure: Changes in risk behavior and health care seeking behavior
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
Study officials:
affiliation: CDC/NCHSTP/DSTDP/BIRB
name: Samantha Williams, Ph.D.
role: STUDY_CHAIR
affiliation: University of Alabama at Birmingham
name: Diane Grimley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03809754: Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
Official title: Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CHD - Coronary Heart Disease
Percutaneous Coronary Intervention
In-stent Restenosis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Patients with angina or evidence of myocardial ischaemia
* Patients with restenotic lesions in a previously DES area of a coronary artery
* Patients suitable to receive any types of percutaneous coronary intervention (including balloon angioplasty and stent implantation)
* The stent diameter of DES-ISR is 2.5mm to 4.0mm
* Target lesion length \< 30mm
* Target lesion stenosis ≥ 70% diameter stenosis on visual assessment, or ≥ 50% diameter stenosis and with evidence of myocardial ischaemia ischemic

Exclusion Criteria:

* Patients with acute myocardial infarction with 1 week
* Patients with evidence of extensive thrombosis in the target vessel
* Patients with left main coronary artery disease
* Patients with cardiogenic shock, left ventricular ejection fraction \< 40%,significant renal dysfunction and severe heart valve disease
* Patients who had cerebral stroke within 6 months before PCI
* Patients with a life expectancy \< 1 year
* Patients not able to adhere to follow-up visits

Primary outcomes:
measure: In-segment late loss at 9 months follow-up
timeFrame: 9 months
Secondary outcomes:
measure: Rates of acute success
timeFrame: 1 month
measure: Rate of 9-month binary restenosis
timeFrame: 9 months
measure: Number of Participants with target lesion failure (TLF)
timeFrame: 12 months
measure: Rate of major adverse cardiovascular events
timeFrame: 12 months
measure: Number of participants with all-cause death
timeFrame: 12 months
measure: Rate of myocardial infarction
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yundai Chen
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03409354: Tele-Rehabilitation Pilot Evaluation Study
Official title: Tele-Rehabilitation Pilot Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Bone
Stroke
Lower Limb Joint Replacement (Hip or Knee)
Lower Limb Amputation
Pneumonia
Fall
Deconditioning
Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis)
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A proof of concept randomized controlled trial (RCT) only evaluated the National University of Singapore's (NUS) T-Rehab tele-rehabilitation (TR) system at a home setting where rehabilitation was provided on an individual level. The previous RCT was also limited to stroke patients. In addition to stroke, there are many other conditions (such as fractures, lower limb joint replacement, musculoskeletal conditions) require and benefit from rehabilitation. The primary aims of the pilot evaluation study are: (i) To document patient adherence to TR, compared to usual care (ii) To estimate the extent to which TR improves functional status, compared to usual care and (iii) To estimate the cost effectiveness of TR, compared to usual care in eight different health conditions in Singapore.

Detailed description: This is a 12-week quasi-experimental trial of a tele-rehabilitation program involving seven sites and up to 600 adults in Singapore.

Eligibility criteria: Inclusion Criteria:

* at least 21 years of age
* Admitted into an inpatient or outpatient rehabilitation unit, nursing home or day care centre for an acute or chronic disability
* Deemed by any members of the multi-disciplinary rehabilitation team to potentially able to safely receive and benefit from rehabilitation post-discharge
* Cognitively able to understand and follow instructions (the Abbreviated Mental Test's score of 6 or above (out of 10).

Exclusion Criteria:

* Patients with previous seizure episodes
* Patients with limb musculoskeletal pain of at least moderate intensity (visual analogue Scale \> 6 out of 10)
* Patients with pacemakers.

Primary outcomes:
measure: Adherence to rehabilitation over the course of a 2 week trial period
timeFrame: At 12-weeks post-rehabilitation
Secondary outcomes:
measure: EQ-5D
timeFrame: 12-weeks
measure: CESD
timeFrame: 12-weeks
measure: IADL
timeFrame: 12-weeks
measure: Barthel Index
timeFrame: 12-weeks
measure: Health Service Utilization
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Miho Asano
Study officials:
affiliation: National University of Singapore
name: Miho Asano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01287754: A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
Official title: A Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-02-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
* Measurable disease according to RECIST criteria
* ECOG performance status 0-2
* Adequate haematological, renal and liver function

Exclusion Criteria:

* Previous chemotherapy or therapy against EGFR for metastatic disease
* History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
* Symptomatic cerebral metastases
* Pre-existing parenchymal lung disease such as pulmonary fibrosis
* Concomitant use of coumarins

Primary outcomes:
measure: Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation
timeFrame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
Secondary outcomes:
measure: Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1
timeFrame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
measure: Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants
timeFrame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
measure: Percentage of Participants Alive at 6 and 12 Months
timeFrame: At 6 and 12 months
measure: Percentage of Participants With EGFR Mutation at Screening
timeFrame: Screening
Other outcomes:
Locations:
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Oulu
country: Finland
city: Pori
country: Finland
city: Turku
country: Finland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01255254: The Effect of Oral Hygiene and Full Mouth Scaling on Metabolic Control in Patients With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gingival Scaling
Metabolic Control
Keywords: he effect of gingival scaling on Metabolic control
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of non-surgical periodontal therapy, consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the metabolic control of chronic periodontitis patients with type II diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

1. Age 25- 75 years;
2. Type 2 diabetes;
3. Chronic periodontitis with 2 or more teeth with CAL≥6mm and one site with a PD≥5mm ("established periodontitis")16

Exclusion Criteria:

1. Periodontal treatment within the last 3 months
2. The use of antibiotics within the last 4 weeks
3. Pregnancy or the intention to be pregnant in the next 4 months

Primary outcomes:
measure: Metabolic control
timeFrame: 3 months
Secondary outcomes:
measure: Inflammation
timeFrame: 3 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Periodontology, School of Graduate Dentistry Rambam Health care campus
Study officials:
References:
Clinical trial NCT02318654: Ice Versus EMLA for Pain in Laser Hair Removal
Official title: Comparing the Efficacy of Ice Pack Versus Topical EMLA for Pain Control in Laser Axillary Hair Removal: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hair Removal
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the efficacy of ice pack to topical eutectic mixture of local anesthesia (EMLA) for pain control in diode 810 nm laser axillary hair removal.

This study is a pilot study designed to determine feasibility of these procedures.


Eligibility criteria: Inclusion Criteria

1. Subjects are Caucasian or Asian females.
2. Subjects are 18-65 years old.
3. Subjects have Fitzpatrick skin type I-III and coarse dark axillary hair.
4. Subjects are in good health.
5. Subjects can provide informed consent.
6. Subjects have the willingness and the ability to understand and communicate with the investigators.

Exclusion Criteria

1. Subjects who are allergic to lidocaine or prilocaine.
2. History of methemoglobinemia.
3. History of recurrent petechial or purpuric lesions.
4. Bleeding tendency or coagulopathy.
5. History of laser treatment in axilla.
6. History of keloid or hypertrophic scarring.
7. Pregnant or lactating or intends to become pregnant in the next 3 months.
8. Active skin disease or skin infection in the treatment area.
9. Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders and cognitive disorders.
10. History of cold urticaria.
11. History of current injury or abnormal skin sensation.
12. Unable to understand the protocol or to give informed consent.
13. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to subject.

Primary outcomes:
measure: Pain using the SF-MPQ immediately after treatment
timeFrame: immediately (at 0 min) after laser treatment
measure: Pain using the SF-MPQ 5 minutes after treatment
timeFrame: 5 mins after laster treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: