louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03449927: Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake
Official title: A Pilot Study of Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melphalan Autologous Transplant
Keywords: Nutrition Tool
Melphalan Autologous Transplant
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
First posted: 2018-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot before and after interventional study is to determine if early intervention and provision of menus regarding appropriate diet choices for melphalan autologous transplant patients experiencing nausea and diarrhea will improve nutrition status and overall calorie and protein intake throughout the transplant process.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing melphalan autologous transplants will be included in this study
* All patients that will be included in this pilot before and after interventional study will be inpatient on floors 5900, 6900 or 8900 of Barnes-Jewish Hospital
* Per hospital protocol, all patients who will receive a melphalan autologous transplant will be admitted and remain inpatient for the duration of the transplant process. There will be no exclusion for dietary restrictions or food allergies as the foodservice provided to patients is room service, all food allergies are noted and suitable alternatives are provided as a standard of service.
* Once a patient has been determined to meet criteria for the study, they will be approached by a member of the research team between day -2 and day 0 of transplant for consent. Patients must consent for the study by day +1 of transplant to be enrolled.

Exclusion Criteria:

* Patients \<18 years of age
* Pregnant women
* Prisoners
* Patient unable to provide informed consent.

Primary outcomes:
measure: Pre and post intervention mean total caloric intake
timeFrame: Through count recovery (10 days)
measure: Mean total protein intake
timeFrame: Through count recovery (10 days)
Secondary outcomes:
measure: Mean daily caloric intake
timeFrame: Through count recovery (10 days)
measure: Mean daily protein intake
timeFrame: Through count recovery (10 days)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kathleen Stockmann, MS, RD, LD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Meaghan Ryan, MSN, FNP-BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04703127: Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.
Official title: Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Premature Ejaculation
Keywords: Premature Ejaculation
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
Primary purpose: TREATMENT

Brief summary: Therefore, this study will aim to assess the effectiveness and tolerability of the on-demand use of combined dapoxetine with tadalafil and combined dapoxetine with lidocaine 5% spray in treatment of patients with lifelong premature ejaculation and non-responding to dapoxetine alone.

Detailed description: This study will be carried out on 60 patients with lifelong premature ejaculation and non-responding to dapoxetine alone.

All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.

Eligibility criteria: Inclusion Criteria:

* lifelong premature ejaculation and non-responding to dapoxetine alone.

Exclusion Criteria:

* diabetes mellitus,
* chronic prostatitis,
* Advanced renal or hepatic diseases
* neurological diseases
* C.N.S. medications

Primary outcomes:
measure: Intravaginal ejaculatory latency time (IELT)
timeFrame: 0-8 weeks
measure: Arabic Index of Premature Ejaculation (AIPE)
timeFrame: 0-8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Mohammed Abu El-Hamd
Study officials:
affiliation: Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University
name: Mohammed A El-Hamd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02099227: Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections
Official title: Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Infection
Keywords: pediatric
soft tissue infections
ultrasonography
effectiveness
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: American College of Emergency Physicians
name: Newark Beth Israel Medical Center
name: Baylor College of Medicine
name: UCSF Benioff Children's Hospital Oakland
name: Maimonides Medical Center
name: Montefiore Medical Center
First posted: 2014-03-28
Enrollment: 280
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children presenting to participating pediatric emergency departments

Brief summary: To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric skin and soft tissue infections treatment failure rate, as well as emergency department process outcome.


Eligibility criteria: Inclusion Criteria:

* history and examination findings consistent with possible abscess or cellulitis per the treating clinician.
* minimal lesion diameter for inclusion is 1cm.

Exclusion Criteria:

* suspected soft tissue infections involving or near mucosal membranes (e.g. perirectal, peritonsillar, vulvovaginal areas)
* facial lesions
* paronychia or felon
* parent or patient refusal of consent
* unsuitable subjects deemed by treating clinicians.

Primary outcomes:
measure: treatment failure rate
timeFrame: 7-10days
Secondary outcomes:
measure: emergency department process outcome
timeFrame: 7-10days
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
Study officials:
affiliation: advocate christ medical center
name: Samuel Lam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03976427: Translating Neuroscience to Population Health
Official title: Changing How the Brain Responds When Making Decisions: Translating Neuroscience to Population Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be assigned to a guided imagery exercise
Primary purpose: BASIC_SCIENCE

Brief summary: The current study will examine the relationship between brain responses and a guided imagery exercise in overweight and obese individuals. Results of this work are highly relevant to public health because they employ neuroimaging methods to understand food decision-making. Findings from this study will inform health decision making and holds great potential for future translation across multiple health behaviors and scalable interventions to impact population health

Detailed description: Negative health behaviors (e.g. overeating, smoking) are associated with increased negative health outcomes. Engaging in healthy behaviors is not always rewarding (e.g. carrot vs. cake). Neural models of healthy behaviors focus on the balance between reward and regulation brain regions. The current pilot application examines the engagement of these regions during the evaluation of food and nonfood cues before and after a guided imagery exercise targeting positive associations with food and regulation.

The long-term goal is to understand the interaction between positive associations with healthy foods and thinking about future rewards may influence healthy decision-making. The objective of the current study is to empirically test the combined effects of positive affect and positive episodic future thinking on brain activation.

Eligibility criteria: Inclusion Criteria:

* body mass index 25 to 55 kg/m2
* right-handed
* not currently dieting or attempting to lose weight.

Exclusion Criteria:

* serious medical illness unsuitable for the magnetic resonance imaging scanner based on best clinical judgment
* any neurologic or current psychiatric diagnosis
* currently taking anti-seizure medication
* history of concussion
* left-handedness
* risk for hazard due to magnetic fields such as metal in the body surgically or accidentally
* pregnancy

Primary outcomes:
measure: Brain Activation in Self-Regulation Brain Regions
timeFrame: 1 hour
measure: Brain Activation in Reward Brain Regions
timeFrame: 1 hour
Secondary outcomes:
measure: Food Choice
timeFrame: 1 hour
measure: Food Demand
timeFrame: 1 hour
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT01060527: Altered Faecal Protease Activity in Irritable Bowel Syndrome Patients in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome,protease activity,China
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients in the second affiliated hospital of xi'an jiaotong university

Brief summary: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder haracterised by abdominal pain or discomfort associated with altered bowel habits,while the mechanism is still not understood.Recent advances have conceptualized the faecal supernatants of diarrhoea-predominant IBS have a substantially higher serine protease activity, while in china,almost no studies have reported about protease activity in IBS.


Eligibility criteria: Inclusion Criteria:

* Patients fulfilling the Rome III criteria for IBS participated in the study -

Exclusion Criteria:

* Organic gastrointestinal disorders were excluded by detailed blood and stool analyses, serological assays and colonoscopy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00472927: Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
Official title: An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-14
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).


Eligibility criteria: Inclusion Criteria:

* Healthy, postmenopausal women, aged 35 to 70 years
* Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ≥38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55
* BMI in the range of 18 to 35 kg/m2

Exclusion Criteria:

* History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic)
* History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
* Use of prescription or investigatioanl drugs within 30 days before test article administration

Primary outcomes:
measure: Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04586127: Improving Care Coordination for Adolescents and Young Adults With Cancer
Official title: Improving Care Coordination for Adolescents and Young Adults With Cancer: Implementing a Bridge Between Needs and Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: adolescents
care coordination
cancer care needs
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-10-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to test an intervention designed to identify cancer needs and connect patients with services that address those needs. Participation in this research will involve completing 2 online surveys over the course of 1 month; each should take about 15 minutes to complete.

Detailed description: Adolescents and young Adults (AYA) Needs Assessment \& Service Bridge (AYA NA-SB) includes a holistic Patient Reported Outcome Measures (PROM) assessing AYAs' physical, psychosocial and practical needs and a collection of referral pathways for connecting AYAs to services and resources based on the needs they report.

To assess the implementation of AYA NA-SB, the study team will pilot AYA NA-SB in the North Carolina Cancer Hospital (NCCH)/ UNC Children's Hospital, with a primary focus on implementation outcomes (i.e., feasibility, acceptability, appropriateness, fidelity). To establish proof-of-concept for AYA NA-SB, the study team will use pilot data to generate preliminary evidence on the extent to which AYA NA-SB addresses AYAs' reported needs.

Eligibility criteria: Inclusion Criteria:

* AYAs with cancer ages 18 through 39 currently undergoing cancer treatment at the North Carolina Cancer Hospital/ UNC Children's Hospital

Exclusion Criteria:

* Patients who decline to participate in the study

Primary outcomes:
measure: Feasibility of Intervention Measure (FIM) AYA
timeFrame: Week 5
measure: Acceptability of Intervention Measure (AIM) AYA
timeFrame: Week 12
measure: Intervention Appropriateness Measure (IAM) AYA
timeFrame: Week 5
measure: Number of Participants Who Received Services
timeFrame: Week 12
measure: Needs Met Questionnaire
timeFrame: Week 12
Secondary outcomes:
measure: Number of AYA Needs
timeFrame: Week 12
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Cancer Hospital
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Emily Haines, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01120327: A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
Official title: A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-05-10
Enrollment: 212
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. OBJECTIVES

   Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max, mL/kg/min) in amlodipine group against no CCB group at 9 months

   Secondary objectives To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at 9 months
2. SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea


Eligibility criteria: Inclusion Criteria:

* Stable angina patient with angiographically confirmed significant residual stenosis
* Stenosis more than 50% in 2 major coronary arteries at least or Stenosis more than 75% in 1 major coronary artery

Exclusion Criteria:

* No other pulmonary/psychiatry/musculoskeletal disorder limiting CPET
* Contraindicated to the CPET (e.g. unstable angina, aortic stenosis, uncontrolled hypertension, uncontrolled asthma, hypoxemia at rest, epilepsy, locomotor disorder, severe hypertension and febrile illness)

Primary outcomes:
measure: Exercise capacity
timeFrame: 9 months
Secondary outcomes:
measure: Sublingual Nitrate
timeFrame: 1month and 3 months
measure: Biomarkers
timeFrame: 9 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076127: Effect of Kettlebell Training on Musculoskeletal and Cardiovascular Health
Official title: Effect of Kettlebell Training on Musculoskeletal and Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorders
Lead sponsor: National Research Centre for the Working Environment, Denmark
Sponsor class: OTHER_GOV
First posted: 2010-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Neck/shoulder and back pain is quite common among employees in sedentary occupations. Furthermore, many have a low level of fitness. Strength training with dumbbells has been shown to alleviate neck/shoulder pain, but many people prefer to also have alternative training options. Empirically, kettlebell training works the neck/shoulder/back while at the same time training the cardiovascular system. This type of training has not previously been tested in a randomized controlled trial. The aim of this study is to test the effect of kettlebell training on musculoskeletal pain, fitness, and muscle strength.


Eligibility criteria: Inclusion Criteria:

* employed
* office workers

Exclusion Criteria:

* trauma
* life threatening diseases
* pregnancy

Primary outcomes:
measure: Pain in the neck/shoulder and back
timeFrame: before and after the 8-week intervention
measure: Muscle strength
timeFrame: before and after the 8-week intervention
measure: Fitness (VO2-max)
timeFrame: before and after the 8-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Novo Nordisk
Study officials:
affiliation: National Research Centre for the Working Environment, Denmark
name: Lars L Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jay K, Frisch D, Hansen K, Zebis MK, Andersen CH, Mortensen OS, Andersen LL. Kettlebell training for musculoskeletal and cardiovascular health: a randomized controlled trial. Scand J Work Environ Health. 2011 May;37(3):196-203. doi: 10.5271/sjweh.3136. Epub 2010 Nov 25.
Clinical trial NCT03447327: Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma
Official title: Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Subdural Hematoma
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-02-27
Enrollment: 67
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the work: Is to evaluate the prognosis of single burr hole under local anesthesia in management of CSDH according to clinical picture, risk factors, and age.

Detailed description: Patients and methods: We studied 67 consecutive patients with CSDH operated by single burr hole craniostomy under local anaesthesia from Mars, 2014 to February, 2015 in Zagazig University Hospitals according to the aetiology, clinical picture, risk factors, and complications.

Eligibility criteria: Inclusion Criteria:chronic subdural hematoma above 19 years old -

Exclusion Criteria:age below 19 years acute subduralhematoma uncoperative patients

-

Primary outcomes:
measure: Glasgow Outcome Scale
timeFrame: 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: