louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01127737: Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
Official title: Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Squamous Cell Carcinoma
Keywords: SCCs
Squamous Cell Carcinoma
Skin Self Exam
SSE
Organ Transplant
Performance of SSE with our written educational intervention
Time after organ transplantation to deliver intervention
Evaluate internation information
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Using focus group and cognitive interviews with organ transplant recipients, the investigators developed interactive workbooks: a) prevention by sun protection b) early detection by skin self-examination (SSE). The investigators hypothesis is if the patient learns by acquiring skills in a favorable environment, then the patient may reduce their anxiety, enhance self-efficacy and perform self-management by SSE and sun protection. The investigators also evaluate existing internet sources of primary and secondary prevention of skin cancer for organ transplant recipients.


Eligibility criteria: Inclusion Criteria:

* People with a history of solid organ transplantation within the last 2 years
* Speaks English
* Can see to do SSE, capable of seeing to read a newspaper
* Stable health, patients report a general state of well being

Exclusion Criteria:

* Unable to speak English
* Insufficient vision to see their own skin as determined by their ability to read a newspaper
* Comorbid debilitating disease
* Dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level.

Primary outcomes:
measure: Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Dennis P West, PhD
role: STUDY_CHAIR
affiliation: Northwestern University
name: June K Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson JK, Turrisi R, Mallett KA, Stapleton J, Boone SL, Kim N, Riyat NV, Gordon EJ. Efficacy of an educational intervention with kidney transplant recipients to promote skin self-examination for squamous cell carcinoma detection. Arch Dermatol. 2011 Jun;147(6):689-95. doi: 10.1001/archdermatol.2011.10. Epub 2011 Feb 21.
Clinical trial NCT03043937: Cardiac Diseases With Pregnancy in Benisuef Localities
Official title: Cardiac Diseases With Pregnancy in Benisuef Localities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease Structural Disorder Abscess of Cardiac Septum
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective analytical study is managed to be commenced in Beni-Suef governorate as cooperation between Department of Cardiology and Department of Obstetrics and Gynaecology Beni-Suef University during the period between Jan/2015 and Dec/2016 among women with cardiac diseases during pregnancy regardless gestational age at presentation and up till 6 weeks postpartum in comparison to women free from any cardiac diseases.

Brief summary: The aim of this work is to demonstrate the variation of cardiac diseases among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes


Eligibility criteria: Inclusion criteria

* All pregnant ladies with Cardiac diseases, valvular heart disease, congenital heart disease, ischemic heart disease, cardiomyopathy, arrhythmias , big and pulmonary hypertension, presenting with pregnancy regardless age, any concomitant diseases and type of heart disease will be enrolled.
* A similar number of pregnant females free from previous mentioned cardiac diseases will be studied as controls.

Exclusion Criteria:

Primary outcomes:
measure: Fetomaternal and neonatal outcome
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Benisuef
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT04631237: Developing a Down Syndrome Health Instrument
Official title: Developing a Down Syndrome Health Instrument
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Down Syndrome
Health, Subjective
Keywords: health status
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-11-17
Enrollment: 676
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: Primary caregivers and individuals with DS

Brief summary: Although over 200,000 individuals with DS live in the United States, studies to date have focused on outcomes apart from health. The foundation for this proposal is based on the need to accurately measure health of all individuals - specifically, with DS - and the dearth of available tools for this population. Creating such an instrument will provide a barometer of the current state of health for DS and hold use in future research. In this project, I propose to create an instrument that directly assesses health in DS - the Down syndrome Health Instrument (DHI). More specifically, the aims of this proposal are: 1. To conduct focus groups among caregivers, individuals with DS, panels of experts on DS and primary care physicians, and cognitive interviews to refine a conceptual model of health for DS and create an item pool, 2. To administer the DHI and establish internal validity, reliability, and external validity of the DHI for use in clinical research, and 3. To test the usability of the DHI in two pilot settings: research and clinical. This instrument will measure patient-reported health in DS for the first time and allow measurement of health as an outcome which is not currently possible in this population. This can identify gaps in care, then direct and optimize interventions that will improve care.


Eligibility criteria: Inclusion Criteria:

* Primary caregiver of an individual with DS (individual with DS age: \<22 years)
* Caregiver age: ≥18 years
* Fluent in written and spoken English
* Able to read and provide informed consent

Exclusion Criteria:

* Physical or mental condition of caregiver that would prohibit self-administration of questionnaire
* Mosaic Down syndrome: based on medical record review. If caregiver is uncertain or mosaicism is unknown, we will request additional records.

Primary outcomes:
measure: Survey results, cognitive interviews, and validation
timeFrame: Within 12 months of completion of analysis of surveys
Secondary outcomes:
measure: Focus group results and conceptual model
timeFrame: Within 12 months of completion of focus groups
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: STEPHANIE L SANTORO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002637: Feasibility of the Latella Implant System for Medial Osteoarthritis (OA)
Official title: Evaluation of the Latella Implant System for Lateralization of the Iliotibial Band to Offload the Medial Condyle for Pain Relief in Patients With Medial Osteoarthritis - A Safety Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Cotera, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this study is to evaluate the safety and technical feasibility of implanting the Latella Implant System in the treatment of patients with medial osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* History of pain as due to medial osteoarthritis

Exclusion Criteria:

* Rheumatoid arthritis
* Joint or ligament instability
* Metal ion allergy

Primary outcomes:
measure: Freedom from unanticipated serious adverse device effects
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Slotervaart Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
affiliation: Barts & The London NHS Trust
name: Manoj Ramachandran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04203537: Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
Official title: A Two-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics and Preliminary Efficacy Study of CA-008 in Patients Undergoing Total Knee Arthroplasy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postsurgical Pain
Lead sponsor: Concentric Analgesics
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design
Primary purpose: TREATMENT

Brief summary: In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.

Detailed description: Not provided

Eligibility criteria: Inclusion Criteria:

* Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia
* Aged 18-80 years old
* ASA physical class 1, 2, or 3
* BMI \</= 42 kg/m2
* Generally healthy

Exclusion Criteria:

* Concurrent condition requiring analgesic treatment during study period
* Opioid tolerant
* Known allergy to capsaicin or other study medication
* Use of prohibited medications

Primary outcomes:
measure: Pain Intensity Scores
timeFrame: 0 to Day 15 post dose
Secondary outcomes:
measure: Total Opioid Consumption
timeFrame: 0 to Day 15 post dose
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Reserach, LLC
state: California
city: Carrollton
country: United States
facility: Legent Orthopedic Hospital
state: Texas
city: Houston
country: United States
facility: First Surgical Hospital
state: Texas
city: Plano
country: United States
facility: Plano Surgical Hospital
state: Texas
Study officials:
affiliation: HD Research
name: Daneshvari Solanki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01924637: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-08-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period inpatient period

Primary outcomes:
measure: Mean change in plasma glucose concentration
timeFrame: From 0-2 hours after administration
Secondary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 1 hour
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374
citation: Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017 May;56(5):551-559. doi: 10.1007/s40262-017-0514-8.
Clinical trial NCT00003737: Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma
Official title: A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: recurrent neuroblastoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating children who have relapsed or refractory neuroblastoma.

Detailed description: OBJECTIVES:

* Determine the response rate to rebeccamycin analogue in children with relapsed or refractory neuroblastoma.
* Determine the toxicity of this drug in these patients.
* Identify and establish in vitro biologic correlates of clinical responses and toxicity of this drug in these patients.

OUTLINE: Patients receive rebeccamycin analogue IV over 1 hour once on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: This study will accrue up to 30 patients within 1.5 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically proven relapsed or refractory neuroblastoma
* Measurable disease

PATIENT CHARACTERISTICS:

Age:

* Children

Performance status:

* ECOG 0-2

Life expectancy:

* At least 2 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin less than 1.5 mg/dL
* SGOT and SGPT less than 2.5 times upper limit of normal (ULN)
* Adequate liver function unless due to disease

Renal:

* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance at least 60 mL/min
* Adequate renal function unless due to disease

Other:

* No other serious concurrent illness
* No active uncontrolled infection
* Not pregnant
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Recovered from prior immunotherapy
* Prior autologous bone marrow transplantation allowed
* No concurrent immunotherapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy and recovered
* No other concurrent systemic chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Recovered from prior radiotherapy

Surgery:

* Not specified

Primary outcomes:
measure: Response (complete response, very good partial response, or partial response)
measure: Freedom from progression
measure: Time to treatment failure
Secondary outcomes:
measure: Toxicity
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Tanya Trippett, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05025137: Flexi-Bar and Multi-Component Exercises
Official title: Comparing the Effectiveness of Flexi-Bar and Multi-Component Exercises on Improving the Frailty, Physical Fitness, and Musculoskeletal Discomfort of Older Adults: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 88
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Previous studies have suggested that both Flexi-Bar and Multi-Component exercises can improve an individual's physical fitness and musculoskeletal discomfort. However, determining which is more effective in enhancing the frailty, physical fitness, and musculoskeletal discomfort of the elderly remains controversial.

Objective: This study aims to investigate differences in the effectiveness of Flexi-Bar and Multi-Component exercises in improving the frailty, physical fitness, and musculoskeletal discomfort of the elderly after 12 weeks of intervention.

Methods: A single-blind randomized controlled trial was conducted to collect data from a city in central Taiwan. Participants were randomly divided into a Flexi-Bar group (FB group) and a Multi-Component exercise group (MCE group). Participants in the FB group performed a 60-minute Flexi-Bar exercise every week for 12 consecutive weeks. Meanwhile, Participants in the MCE group performed a 60-minute Multi-Component exercise every week for 12 consecutive weeks. Tests were conducted both before and after the 12-week intervention using items including the Kihon Checklist, Senior Fitness Test, and Nordic Musculoskeletal Questionnaire.


Eligibility criteria: Inclusion Criteria:

* (1) participants aged 65 years and over;
* (2) participants who could communicate in Mandarin or Taiwanese and cooperate with sports activities; and
* (3) participants who could walk independently without assistance (or with aid).

Exclusion Criteria:

* (1) participants with unstable physiological conditions (or those who were recommended against participating in physical activities by their doctor);
* (2) participants with unstable mental conditions; and
* (3) participants who could not complete the 12-week exercise intervention.

Primary outcomes:
measure: Kihon Checklist
timeFrame: 10-15 minutes
Secondary outcomes:
measure: Senior Fitness Test
timeFrame: 30-40 minutes
measure: Nordic Musculoskeletal Questionnaire
timeFrame: 10-15 minutes
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia University
state: WuFeng
Study officials:
References:
Clinical trial NCT01203137: Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Regurgitation
Keywords: tricuspid regurgitation, severe
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We prospectively recruited consecutive patients with isolated (without any other valvular dysfunction) severe TR who underwent corrective surgery.

Brief summary: Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We attempted to explore whether early postoperative echocardiography provides additional prognostic information on top of preoperative clinical and echocardiographic variables.

Detailed description: We prospectively recruited patients with isolated severe TR undergoing corrective surgery. Comprehensive preoperative echocardiography was performed in all patients, with the performance of early postoperative echocardiography in all patients. During follow-up, clinical events, defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems were investigated.

Eligibility criteria: Inclusion Criteria:

* severe tricuspid regurgitation

Exclusion Criteria:

* concomitant left-sided valve surgery
* significant coronary artery disease

Primary outcomes:
measure: clinical event
timeFrame: 40 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06594237: Maternal And Fetal Outcomes in Pregnant Women With Liver Disease
Official title: Maternal And Fetal Outcomes in Pregnant Women With Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fulminant Hepatic Failure
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 195
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant females with gestational age \> 24 weeks, regardless of their parity or gravidity status, with liver disease were enrolled in this study. Those with renal disease or any kinds of malignancy were not part of the study.

Brief summary: Liver disease complications during pregnancy can impact maternal and neonatal health, though not many studies are on view to investigate maternal and fetal outcomes in Pakistani pregnant women. So, this study was aimed to determine the maternal and fetal outcomes among pregnant females with liver disease.


Eligibility criteria: Inclusion Criteria:

* Pregnant females with liver disease
* With gestational age \> 24 weeks
* Any parity or gravidity status

Exclusion Criteria:

* Pregnant females with renal disease or any kind of malignancy

Primary outcomes:
measure: Maternal or Fetal survival or mortality.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Nishtar Medical University
state: Punjab
Study officials:
affiliation: Department of Obstetrics & Gynecology, Nishtar Hospital, Multan
name: Mehnaz Khakwani, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics & Gynecology, Nishtar Hospital, Multan
name: Hajra Sultana, FCPS
role: PRINCIPAL_INVESTIGATOR
References: