louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02165657: Excimer Laser, Serum Markers & Psoriasis
Official title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psoriasis
Keywords: Excimer laser
UVB
Psoriasis
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Photomedex
First posted: 2014-06-17
Enrollment: 0
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 overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment.

The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm excimer laser will decrease the levels of serum inflammatory markers. The investigators hypothesize that treatment will decrease plaque erythema and will result in minimal hyperpigmentation.

Detailed description: Subjects will undergo Excimer treatment twice a week until they reach a PASI 75 improvement, or until they reach the maximum of 20 total treatments. A blood draw to assess serum inflammatory markers will be performed at the screening visit and final visit. Chromameter assessment, photographs, PASI and PGA (Physician Global Assessment) will be performed throughout the study to monitor psoriasis improvement, hyperpigmentation and erythema.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Male or female with diagnosis of psoriasis
* Psoriasis involvement of 5-15% BSA
* Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks
* Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks
* Fitzpatrick Skin Types I-VI

Exclusion Criteria:

* Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
* Any suspicion that the psoriasis is of the photosensitive variant.
* Any medical condition that could be aggravated or may cause extreme discomfort during the study period.

Primary outcomes:
measure: Change in serum inflammatory markers
timeFrame: 23 visits (~12 weeks)
Secondary outcomes:
measure: Objective measure of hyperpigmentation
timeFrame: 23 visits (~12 weeks)
measure: Objective measure of erythema
timeFrame: 23 visits (~12 weeks)
measure: Improvement in Psoriasis based on PASI assessment
timeFrame: 23 visits (~12 weeks)
measure: Improvement in psoriasis based on PGA
timeFrame: 23 visits (~12 weeks)
Other outcomes:
Locations:
city: Concord
country: United States
facility: University Hospitals Cleveland Medical Center (Concord Site)
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Margaret Bobonich, NP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02441257: Gastroesophageal Reflux During LMA in Control Ventilation (LMA, Laryngeal Mask Airway)
Official title: Incidence of Gastroesophageal Reflux During LMA Application in Control and Spontaneous Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux
Laryngeal Mask Airway
Control Ventilation
Spontaneous Ventilation
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2015-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Laryngeal mask airway is seldom used for control ventilation in America, while it is popular in China. The question is whether the incidence of gastroesophageal reflux in control ventilation is really higher than in spontaneous ventilation. So the investigators combine the third generation laryngeal mask and catheter-based Digitrapper ph-Z monitor system to evaluate the exact incidence of gastroesophageal reflux in these two groups.

Detailed description: Patients scheduled for LMA ventilation are divided into two groups randomly, control ventilation group and spontaneous ventilation group. After the third generation laryngeal mask is inserted, catheter-based Digitrapper ph-Z monitor system is applied to measure the exact incidence of gastroesophageal reflux in these two groups.

Eligibility criteria: Inclusion Criteria:

* patients for lower extremity operations;
* patients for urological operations;
* patients for gynecological operations.

Exclusion Criteria:

* gastroesophageal reflux disease;
* body mass index more than 30.

Primary outcomes:
measure: incidence of gastroesophageal reflux of participants
timeFrame: participants will be monitored for the duration of laryngeal mask application, an expected average of 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Zhenmeng Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04328857: Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
Official title: Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acquired Brain Injury
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: CNR - ICMATE UOS di Lecco
First posted: 2020-03-31
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed clinical investigation plan is a pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury.

The primary objective of the clinical study is to evaluate the improvement of joint stiffness through the use of sensorized pseudoelastic orthoses for the rehabilitation of pediatric patients with acquired brain injury.

The effectiveness of the treatment in terms of joint stiffness (primary outcome) will be assessed and the effect of the treatment will be quantified with clinical evaluation scales and instrumental measurements by means of an optoelectronic system and isokinetic machine. The tolerability and acceptability of the device will also be checked.


Eligibility criteria: Inclusion Criteria:

1. Quadriplegia or acquired hemiplegia.
2. Age 6-20 years.
3. Dystonic, dyskinetic, spastic.
4. Chronic phase patients (\> 1 year post event).
5. Spastic syndrome with Ashworth Score (AS) for the limb of interest\> 1.
6. Collaborative.

Exclusion Criteria:

1. Fixed limitations of the joint.
2. Joint pain.
3. Skin allergies.
4. Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).

Primary outcomes:
measure: Joint Stiffness of affected upper limb joint
timeFrame: After 4 weeks of treatment
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: After 4 weeks of treatment
measure: Melbourne Upper Limb Assessment 2
timeFrame: After 4 weeks of treatment
measure: Quality of Upper Extremity Skills Test
timeFrame: After 4 weeks of treatment
measure: Active range of motion
timeFrame: After 4 weeks of treatment
measure: Passive range of motion
timeFrame: After 4 weeks of treatment
measure: Range of motion of target joint during a pointing-forward task
timeFrame: After 4 weeks of treatment
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Eugenio Medea
state: LC
Study officials:
References:
Clinical trial NCT06371157: A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
Official title: A Phase III, Randomized, Double-blinded, Multicenter Study of Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2024-04-17
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma


Eligibility criteria: Inclusion Criteria:

1. Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD)
2. No evidence of metastasis
3. Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
4. Child Pugh score class A
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
6. Measurable disease by RECIST 1.1
7. Adequate organ function

Exclusion Criteria:

1. History of liver transplantation
2. History of hepatic encephalopathy
3. Uncontrolled arterial hypertension
4. Deep venous thrombosis within 3 months before first treatment
5. Bleeding events within the last 6 months
6. Co-infection with HBV and HCV

Primary outcomes:
measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
measure: PFS per RECIST 1.1
timeFrame: Up to approximately 2 years
measure: Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DOR) per RECIST 1.1 and mRECIST
timeFrame: Up to approximately 2 years
measure: Disease Control Rate (DCR) per RECIST 1.1 and mRECIST
timeFrame: Up to approximately 2 years
measure: Time to Response (TTR) per RECIST 1.1 and mRECIST
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Guoliang Shao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongda Hospital
name: Gaojun Teng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01912157: Couples Coping With Multiple Chronic Medical Conditions
Official title: Couples Coping With Multimorbidity: Does Solitary Expressive Writing Foster Psycho-social Adaptation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Illness Behavior
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Handling of complex health situations (as defined by multimorbidity) in partnership: communication between romantic partners; subjective illness perception; coping with stressful experiences due to multimorbidity.

Intervention : Expressive Writing about subjective illness perception vs. Writing about individual Time-Management Primary Endpoint: subjective Health (e.g. SF 12 questionnaire) Secondary Endpoints: Psychosocial Adjustments (Depression, somatic symptoms, quality of partnership and others)

Detailed description: Coping in complex health situations (as defined by multimorbidity) and the role of relationship processes for psycho-social adaption: The study investigates interpersonal emotion regulation, disclosure, and illness perceptions in couples with a multimorbid patient. The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing), the control condition are 3 sessions writing about individual time-management (placebo).

Primary endpoint: subjective health (SF 12 questionnaire) Secondary endpoint: psychosocial adjustments (depression, positive and negative affect, somatic symptoms, adjustment disorder, marital satisfaction, sleep quality)

Eligibility criteria: Inclusion criteria:

* Age 18 or older
* multimorbid condition (two or more chronic medical conditions)
* patients living with romantic partner
* very good oral and written command in German
* written consent for participation by patient and partner

Exclusion criteria:

* Pregnancy
* Mini Mental State less than 26
* Substance Abuse
* Patients in Palliative Situation
* Patients isolated due to infectious diseases
* Patients participating in other clinical trials within the last 4 weeks before inclusion

Primary outcomes:
measure: Subjective health (SF-12)
timeFrame: 3 months
Secondary outcomes:
measure: Psychosocial adjustments
timeFrame: 3 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Internal Medicine
state: ZH
Study officials:
affiliation: University Hospital Zurich, Internal Medicine
name: Lukas Zimmerli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04989257: 24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial
Official title: 24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High Ischemic Risk
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 3488
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ticagrelor-based dual-antiplatelet therapy vs. Clopidogrel-based dual-antiplatelet therapy
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective randomized clinical trial is to compare the clinical outcomes between aspirin with ticagrelor versus aspirin with clopidogrel in high ischemic risk patients beyond 12 months after percutaneous coronary intervention with drug-eluting stent implantation


Eligibility criteria: Inclusion Criteria:

1. Age ≥50 years old
2. History of drug-eluting stent implantation due to acute myocardial infarction 12 to 24 months ago
3. High-risk for ischemic events (at least one of the following) 1) Age \>65 years old 2) Medical treatments for diabetes mellitus 3) Multi-vessel coronary artery disease 4) More than 2 episodes of myocardial infarction 5) Chronic kidney disease (stage III or IV)

Exclusion Criteria:

1. Age ≥85 years old
2. Pregnant women or women with potential childbearing
3. Life expectancy \< 1 year
4. Inability to understand or read the informed consent
5. Need for long-term anticoagulation therapy

Primary outcomes:
measure: Composite of all-cause death, myocardial infarction, or stroke
timeFrame: up to 24 months
Secondary outcomes:
measure: BARC type 2, 3, or 5 bleeding
timeFrame: up to 24 months
measure: All-cause death
timeFrame: up to 24 months
measure: Myocardial infarction
timeFrame: up to 24 months
measure: Stroke
timeFrame: up to 24 months
measure: Cardiac death
timeFrame: up to 24 months
measure: Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Yonsei University
name: Byeong-Keuk Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03199157: Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain
Official title: The Effect Of Fentanyl 12 Mcg Transdermal Patch On Postoperative Pain Following Unilateral, Single-Level Laminectomy/Discectomy: A Randomized, Controlled, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators designed a prospective randomized study to investigate the effect of fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level laminectomy/discectomy.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 20-70 years
* ASA physical status 1-2 patients undergoing single-level laminectomy/discectomy

Exclusion Criteria:

* A history of allergy to any study drugs
* History of opioid use, obstructive sleep apnea
* Any psychological disorders
* hepatic or renal failure

Primary outcomes:
measure: Numeric rating score for pain (NRS)
timeFrame: Postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05947357: Food for Health Equity: Evaluation of a Nutrition Assistance Program
Official title: Addressing LatinX Cancer Care Equity: Food for Health Equity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Food Insecurity
Food Assistance Quality Improvement Program
Latinx and minority patients
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients as part of a nutrition assistance program will randomly receive food vouchers for $40.00 each month for use in the produce section of local grocery stores for 6 months.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study seeks to evaluate whether a nutrition assistance quality improvement program for patients with cancer and food insecurity receiving active treatment at Pacific Cancer Care will have reductions in food insecurity.

Detailed description: This study seeks to evaluate the effectiveness and patient satisfaction with a nutrition assistance quality improvement program in which a randomly selected 30 patients will receive a food voucher with $40.00 each month for 6 months for use in the produce section at local grocery stores in the county. The primary outcome is understanding whether this program is effective at reducing food insecurity among patients being treated for cancer and will provide key insights that may guide program expansion or improvement.

Eligibility criteria: Inclusion Criteria:

* Patient Participants must be undergoing or starting treatment for cancer at the Pacific Cancer Care clinic who screen positive for food insecurity using at 2-item screener, speak English or Spanish, have capacity to consent (e.g. no dementia or other cognitive impairment), are Latinx or another racial and ethnic minority group OR low income, have public insurance, OR are insured by an agricultural company sponsored health insurance

Exclusion Criteria:

* Patients will be ineligible if they do not have a current cancer diagnosis, cannot communicate in English or Spanish, are deemed ineligible to consent, are under 18 years of age, are not Latinx or another racial/ethnic minority OR are not low income OR are not publicly insured, uninsured, or do not have health insurance from an agricultural company

Primary outcomes:
measure: Food Insecurity
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Food Security
timeFrame: Baseline to 6 months
measure: Health-related quality of life (HRQOL)
timeFrame: Baseline to 6 months
measure: Financial Toxicity
timeFrame: Baseline to 6 months
measure: Health-related social needs
timeFrame: Baseline to 6 months
measure: Satisfaction with the intervention
timeFrame: Baseline to 6 months
measure: Treatment Adherence
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
Clinical trial NCT02199457: A Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)
Official title: An Open Label, Clinical Performance Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Léman Micro Devices SA
Sponsor class: INDUSTRY
First posted: 2014-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A medical device study to assess the clinical accuracy and equivalence to reference devices of the SVSS to satisfy the requirements of the recognised applicable international standards.

Detailed description: The SVSS is designed to measure and display 5 vital signs: pulse rate, blood oxygen saturation (Sp02), blood pressure, body temperature and respiration rate. These results will be compared for accuracy with the results obtained using standard vital sign measurement equipment on the same subject.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, male or female, 18 yrs or older, willing and able to participate and sign the informed consent form.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Primary outcome is satisfactory evidence of substantial equivalence of each of the five vital signs with the reference devices within the ranges specified by the standards.
timeFrame: DAY 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: EPFL
Study officials:
affiliation: Sponsor GmbH
name: Chris Elliott
role: STUDY_DIRECTOR
References: