louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02468089: To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
Official title: A Randomized Study to Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups.

Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.


Eligibility criteria: Inclusion Criteria:

1. Age more than 18 years
2. Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP:

   * Hospital acquired - New onset SBP (Spontaneous bacterial peritonitis) after 48 h of hospitalization.
   * Recurrent SBP - One or more prior episode(s) of SBP in year.
   * Antibiotic resistant - Resistance to 3rd Gen Cephalosporin in last 3 m.
   * Antibiotic non-response -Non-response to 3rd Gen Cephalosporin, sepsis on 3rd Gen Cephalosporin.

Exclusion Criteria:

1. \< 18 years.
2. Advanced HCC (HepatoCellular Carcinoma)
3. Post liver transplant
4. HIV + ve, Immunosuppressive therapy
5. Pregnancy
6. Domiciliary treatment
7. No consent

Primary outcomes:
measure: Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)
timeFrame: 1 week
Secondary outcomes:
measure: Survival at week 2
timeFrame: week 2
measure: Survival at week 4
timeFrame: week 4
measure: Survival at week 12
timeFrame: week 12
measure: Total number of patients develop variceal bleed.
timeFrame: 1 week
measure: Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.
timeFrame: 1 week
measure: Total number of patients develop HE (Hepatic Encephalopathy).
timeFrame: 1 week
measure: Total number of patients develop AKI (Acute kidney Injury).
timeFrame: 1 week
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Vikash Prakash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01720589: Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children
Official title: Development of Rich & Creamy Melt® Organic Cooking Blend for Oxidative Stability and Reducing Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Obesity
Dietary fat
Energy expenditure
Food intake
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: Prosperity Organic Foods
name: USDA Beltsville Human Nutrition Research Center
First posted: 2012-11-02
Enrollment: 5
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich in medium chain triglycerides on energy expenditure and food intake in overweight and obese children.


Eligibility criteria: Inclusion Criteria:

* age 15-18
* body mass index 85% percentile or higher for age/sex
* weight stable

Exclusion Criteria:

* ±5 lbs weight change in the the 3 months prior
* use of medications
* dietary allergies
* metabolic disorder
* eating disorder
* behavioral or psychological disorders

Primary outcomes:
measure: Thermic effect of food
timeFrame: 6 h
measure: Respiratory quotient/fat oxidation
timeFrame: 6 h
measure: Food intake
timeFrame: single meal
Secondary outcomes:
measure: Glucose
timeFrame: 6 h
measure: Feelings of appetite and satiety
timeFrame: 6 h
measure: Insulin
timeFrame: 6 hours
measure: Leptin
timeFrame: 6 hours
measure: Ghrelin
timeFrame: 6 hours
measure: Peptide YY
timeFrame: 6 hours
measure: Glucagon like peptide 1
timeFrame: 6 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's/Roosevelt Hospital
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Marie-Pierre St-Onge, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Prosperity Organic Foods
name: Cygnia Rapp
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03934489: Emotion Regulation Skills Training for Individuals With MS and Their Support Partners
Official title: Reducing Depression and Anxiety in Individuals With Multiple Sclerosis (MS) and Their Support Partners: An Emotion Regulation Skills Training Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2019-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot randomized controlled trial investigates a novel, group-based emotion regulation skills training intervention for reducing anxious and depressive symptomatology and improving emotion regulation and problem solving in individuals with MS and the individual's support partners. Participants will be randomized (1:1) to the intervention ("Partnered Emotion Regulation Skills Intervention and Supportive Teaching \[PERSIST\]") or to the active control (Facilitated Peer Support).


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* able to speak/read in English
* able to commit to attending at least 9 of the 12 weekly group sessions
* individuals with MS must be relapse/exacerbation-free for at least 1 month
* support partners must score at least 8 on the HADS-D or HADS-A
* individuals with MS must score a least 11 on the HADS-D or HADS-A

Exclusion Criteria:

* under 18 years old
* unable to speak/read in English
* unable to commit to attending at least 9 of the 12 weekly group sessions
* MS relapse within 1 month

Primary outcomes:
measure: Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D)
timeFrame: Baseline, 13 and 26 weeks
measure: Change in Anxiety Subscale score of the Hospital Anxiety and Depression Scale (HADS-A)
timeFrame: Baseline, 13 and 26 weeks
Secondary outcomes:
measure: Change in Difficulties in Emotion Regulation Scale (DERS-16) score
timeFrame: Baseline, 13 and 26 weeks
measure: Change in Problem Solving Inventory (PSI) score
timeFrame: Baseline, 13 and 26 weeks
measure: Change in RAND 36-Item Short Form Health Survey (SF-36) score
timeFrame: Baseline, 13 weeks, and 26 weeks
measure: Change in Zarit Burden Interview (ZBI) score
timeFrame: Baseline, 13 weeks, and 26 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Abbey Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02223689: Evaluation of Skin Affix in the Emergency Room
Official title: Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wounds
Keywords: SkinAffix
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 35
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.

Detailed description: Subjects were approached for recruitment in the ED when discussing closure options by the physician. Only subjects deemed appropriate for skin glue closures by their treating physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and at 14 days following the ED visit.

Eligibility criteria: Inclusion Criteria:

* Greater than 5 years of age
* Requires the use of a surgical skin adhesive
* Informed consent signed

Exclusion Criteria:

* Sensitivity to topical adhesive products or formaldehyde
* Hx keloid formation, hypotension, diabetes, blood clotting disorders
* Wound infections
* mucosal surfaces or skin exposed to body fluids

Primary outcomes:
measure: Wound Closure at Discharge
timeFrame: 14 days
Secondary outcomes:
measure: Change in Pain Following Application
timeFrame: 15 minutes Post Application
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
Study officials:
affiliation: Metro Hospital
name: Jon Schrock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005489: Salt Sensitivity, Cardiovascular and Metabolic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Angina Pectoris
Cerebrovascular Accident
Myocardial Infarction
Diabetes Mellitus
Heart Failure, Congestive
Heart Failure
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To identify the role of salt-sensitivity of blood pressure in the pathogenesis of hypertension.

Detailed description: DESIGN NARRATIVE:

Approximately 498 of 750 normal and hypertensive subjects who were carefully characterized in terms of blood pressure response to salt loading and depletion in the late 1970s were re-examined to identify physiological factors contributing to salt-sensitivity of blood pressure. This helped to confirm preliminary observations suggesting that salt sensitivity in normotensive subjects predicted the subsequent development of hypertension with aging. In addition, longitudinal observations in hypertensive patients and in normotensives helped to determine whether salt-sensitivity or salt-resistance of blood pressure were associated with differences in the risk for development of specific forms of cardiovascular disease (stroke, angina, myocardial infarction, congestive heart failure), renal and metabolic (diabetes mellitus) disorders.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University-Purdue University
name: Myron Weinberger
References:
citation: Weinberger MH, Fineberg NS, Fineberg SE, Weinberger M. Salt sensitivity, pulse pressure, and death in normal and hypertensive humans. Hypertension. 2001 Feb;37(2 Pt 2):429-32. doi: 10.1161/01.hyp.37.2.429.
citation: Weinberger M, Weinberger MH, Fineberg N, Fineberg SE, Wagner U. Long-term follow-up of participants in clinical studies. J Clin Epidemiol. 2002 Mar;55(3):230-4. doi: 10.1016/s0895-4356(01)00437-1.
citation: Weinberger MH, Fineberg NS, Fineberg SE. The influence of blood pressure and carbohydrate tolerance on vascular compliance in humans. Am J Hypertens. 2002 Aug;15(8):678-82. doi: 10.1016/s0895-7061(02)02955-2.
citation: Weinberger MH. Salt sensitivity is associated with an increased mortality in both normal and hypertensive humans. J Clin Hypertens (Greenwich). 2002 Jul-Aug;4(4):274-6. doi: 10.1111/j.1524-6175.2002.00924.x.
citation: Weinberger MH, Fineberg NS, Fineberg SE. Effects of age, race, gender, blood pressure, and estrogen on arterial compliance. Am J Hypertens. 2002 Apr;15(4 Pt 1):358-63. doi: 10.1016/s0895-7061(02)02261-6.
Clinical trial NCT02105389: Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
Official title: A Feasibility Study of Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: fatigue
quality of life
chemotherapy
haematopoietic stem cell transplantation
children
pilot
yoga
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 11
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults receiving treatment for cancer, and intensively treated patients may be at higher risk. While exercise is an effective intervention for CRF, patients receiving the most intensive chemotherapy may frequently be too ill to participate in a standardized exercise program. A unique intervention that combines exercise and relaxation is yoga. This pilot study will evaluate the feasibility of three times weekly yoga sessions administered by a trained yoga instructor for a three week duration and will enroll between 10 and 20 children. If feasible, the intervention will be tested in a randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with any acute myeloid leukemia (AML), relapsed acute lymphoblastic leukemia, stage 3 or 4 Burkitt's lymphoma/leukemia or about to receive autologous or allogeneic haematopoietic stem cell transplantation (HSCT)
* Expected to be an inpatient for at least three weeks after initiation of chemotherapy or conditioning
* Ages 7 to 18 years of age at enrollment

Exclusion Criteria:

* Features present to an extent that would preclude compliance with yoga (as assessed by the attending physician): a) motor disability, b) cognitive disability, c) cardiopulmonary symptoms, or d) known compression fracture resulting in disability
* Parent or patient cannot understand English

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: baseline
Secondary outcomes:
measure: Fatigue and Quality of Life outcomes
timeFrame: Change from baseline to day 7, 14 and 21
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
citation: Diorio C, Schechter T, Lee M, O'Sullivan C, Hesser T, Tomlinson D, Piscione J, Armstrong C, Tomlinson G, Sung L. A pilot study to evaluate the feasibility of individualized yoga for inpatient children receiving intensive chemotherapy. BMC Complement Altern Med. 2015 Jan 24;15:2. doi: 10.1186/s12906-015-0529-3.
Clinical trial NCT00090389: Acupuncture for Women's Health Conditions
Official title: New England School of Acupuncture (NESA) Acupuncture Research Collaborative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Neoplasms
Endometriosis
Pelvic Pain
Uterine Neoplasms
Keywords: Acupuncture
Medicine, Chinese Traditional
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-08-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
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 evaluate the safety and effectiveness of acupuncture in treating women's health conditions.

Detailed description: This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy. Study 1 will include women with various forms of cancer. White blood cell counts will be used to assess the effects of acupuncture on participants' immune responses. Study 2 will include women with unspecified pelvic pain and endometriosis; a self-report pain scale will be used to assess the effects of acupuncture on participants' symptoms. Study 3 will evaluate the validity and reliability of diagnoses made by Chinese medicine practitioners. In this study, a group of Chinese medicine practitioners will diagnose the same group of patients; consistency of the diagnoses will be evaluated.

Eligibility criteria: Inclusion Criteria for Study 1:

* Newly diagnosed ovarian cancer; primary peritoneal cancer; papillary serous cancer of the endometrium; or mixed mesodermal tumor of the uterus, ovary, or fallopian tube
* Currently undergoing chemotherapy
* Meet certain laboratory test requirements

Inclusion Criteria for Study 2:

Currently closed to recruitment

* Diagnosed with endometriosis or unspecified pelvic pain

Exclusion Criteria for Studies 1 and 2:

* Use of white blood cell boosters
* Prior radiotherapy with the exception of whole-breast irradiation for breast cancer
* Prior myelotoxic chemotherapy
* History of symptomatic cardiac or psychiatric disorder
* Use of a pacemaker
* Use of herbs or herbal supplements
* Prior use of acupuncture
* Enrollment in other research studies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: New England School of Acupuncture
name: Peter Wayne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02334189: Targeted Letters to Reduce Avoidable Emergency Department Attendances
Official title: Targeted Letters to Reduce Avoidable Emergency Department Attendances
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Avoidable Emergency Department Attendances
Lead sponsor: The Behavioural Insights Team
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to test whether it is possible to reduce pressure on Emergency Departments by sending a personal feedback letter to people who have recently attended an Emergency Department and whose health issues could likely have been dealt with elsewhere. These attendances clearly have many causes. However, it is likely that some attendances are due to behavioural factors - in other words, the various ways in which users interact with services. This study focuses on one particular behavioural factor: lack of feedback to users making avoidable visits.

The study will take place in collaboration with an NHS hospital trust. Each week during the trial, the hospital trust will identify those Emergency Department attendances in the last seven days which, according to clinical judgement, could have been dealt with elsewhere. Patients will then be randomly selected to receive a letter containing information on alternative healthcare options for non-emergency health concerns. Patient records will be analysed to determine whether the patients who received the letter are less likely to make an avoidable repeat visit to the Emergency Department in the future, compared with patients who received no letter.


Eligibility criteria: Inclusion Criteria:

* Adults who attended a participating Emergency Department during the trial period and whose attendance was codes as 'No Investigation No Significant Treatment'

Exclusion Criteria:

* Children under the age of 18
* All departments and hospitals other than participating Emergency Departments.

Primary outcomes:
measure: Number of avoidable Emergency Department re-attendances (Attendances are classified as avoidable using the 'No Investigation No Significant Treatment' code.)
timeFrame: Measured at 4 months after previous attendance
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Behavioural Insights Team
name: Hannah Behrendt, MPhil, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01715389: Evaluation of a Shared Decision Making Portal for Pediatric Asthma
Official title: Evaluation of a Shared Decision Making Portal for Pediatric Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Goals
Shared Decision Making
Patient Portal
Electronic Medical Record
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 81
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot intervention study will test the feasibility and acceptability and explore the outcomes of a primary care-based shared decision making (SDM) electronic medical record (EMR)-based portal that provides education, elicits and tracks patients/families' treatment concerns and goals, assesses symptoms and asthma control over time, and provides decision support to clinicians and families.


Eligibility criteria: Inclusion Criteria:

* Parents/legal guardians of children aged 6-12 with persistent asthma, currently receiving chronic maintenance therapy, cared for at a study practice, with consistent access to a computer with an internet connection where they feel comfortable accessing MyChart (patient portal)
* Clinician at study site

Exclusion Criteria:

* parents non-english speaking
* child's primary care provider at the time of enrollment is a pediatric resident
* not meeting inclusion criteria

Primary outcomes:
measure: Acceptability of the intervention to parents and clinicians
timeFrame: 24 months
Secondary outcomes:
measure: Shared decision making
timeFrame: Baseline
measure: Parent Activation
timeFrame: 0 months, 3 months, 6 months
measure: Goal Attainment
timeFrame: 0 months, 3 months, 6 months then Monthly
measure: Asthma-Related Quality of Life
timeFrame: 0 months, 6 months
measure: Asthma Control
timeFrame: 0 months, 6 months
measure: Asthma-related Utilization
timeFrame: 3 months, 6 months
measure: Asthma Medication Adherence/Receipt
timeFrame: 6 months
measure: Feasibility of Recruitment
timeFrame: 24 months
measure: Feasibility of Follow-up
timeFrame: 24 months
measure: Feasibility of Portal Use
timeFrame: 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Alexander G Fiks, MD, MSCF
role: PRINCIPAL_INVESTIGATOR
References: