louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00267462: Hypertrophic Myopathy in Children
Official title: Retrospective Review of Hypertrophic Myopathy in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric
cardiac
hypertrophic Myopathy
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-21
Enrollment: 75
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to identify the patients seen in our practice who are seen with Hypertrophic Myopathy diagnosis in order to better understand the presenting characteristics of their disease, the diagnostic testing to determine the diagnosis, the methods used to follow the disease progression and management practices used in caring for these patients. The objectives of this data review will be an analysis to determine if there is a methodology that will foster improved diagnostic speed and accuracy, and determine the best management practices based on outcomes in these patients.

Detailed description: The charts of children followed at Sibley Heart Center of Children's Healthcare of Atlanta will be identified using the Mysis system and screening for the appropriate ICD-9 codes for the types of Hypertrophic Myopathy. These codes include: 425.1, 425.4, 425.7, 425.8, and 425.9. Screening will also be done for known anomalies that are associated with hypertrophic myopathy as seen in some syndromes and metabolic disorders.

Data Collection:

Age at presentation (DOB) History - Prenatal, Family, Current Surgical Procedures Physical Exam results EKG interpretation CXR results Echocardiography results MRI Results Holter monitors results Exercise testing results Radionuclear study results Spiral CT Study results Genetics Testing results Medication usage Enzyme replacement therapy usage Diagnostic laboratory results

Statistics:

A generalized linear model will be performed. Significance will be defined at P≤ 0.05.

Interim monitoring of accumulated data will be performed. One interim analysis will be performed after 3 months of accrual with additional analyses being performed at the end of data collection.

Demographic data will be summarized for all subjects. For each patient summary statistics will include the mean, standard deviation, frequency distribution, minimum, maximum and range.

Eligibility criteria: Inclusion Criteria:

* seen at Sibley Heart Center, Children's Healthcare of Atlanta
* diagnosed with Hypertrophic Myopathy

Exclusion Criteria:

* those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Sibley Heart Center Cardiology at Children's Healthcare of Atlanta
name: Kenneth J. Dooley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04042662: Predictors and Outcomes of Meropenem Treatment Failure Among Patients With Septic Shock in Intensive Care Unit
Official title: Predictors and Outcomes of Meropenem Treatment Failure Among Patients With Septic Shock in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Predictors and Outcomes of Meropenem Treatment Failure
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Reference population is septic shock patient who was prescribed with Meropenem and admitted to ICU HUSM from 01/01/2016 - 01/06/2019

Brief summary: Lately, the inappropriate used of Meropenem in critically ill patient were increased. Therefore, increased development of drug resistance bacteria towards Meropenem.

As known that Carbapenem-Resistance Enterobacteriaceae (CRE) is part of complication when Meropenem is widely used in the intensive care unit. CRE are very difficult to treat within Gram negative bacteria as it encodes Carbapenemase enzyme which breaks down Carbapenem anti-microbial such as Meropenem. The widespread carbapenemase production in the Enterobacteriaceae was unknown until the early 2000 until first reported in 2001. Despite that, most doctors and physician favourite, and still prescribe Meropenem as the antibiotic of choice for the critically ill patients empirically. This is because of its broad spectrum of coverage for bacteria. Thus, a number of Meropenem treatment failure were increased as resistance increase.This study will evaluate the appropriate use of Meropenem and determine the predictors of Meropenem treatment failure as well as the patient outcomes.As a result, it can be a guidance prior prescribing the Meropenem base on patient clinical condition and parameters while balancing the risk and benefits of its used.


Eligibility criteria: Inclusion Criteria:

1. Septic shock patient admitted to ICU
2. Age equal or more than 18 years old (No upper limit of age)
3. Receive Meropenem for at least 3 days

Exclusion Criteria:

1. Meropenem as prophylaxis
2. Patient who had culture Carbapenem Resistant Enterobacteriaceae organism (CRE)
3. Patient who admitted with proven diagnosis of Cardiogenic shock

Primary outcomes:
measure: Number of participants with treatment failure with antibiotic meropenem as assessed by clinical criteria of sepsis parameters among patient
timeFrame: 3 years
measure: Number of factors associated with antibiotic meropenem treatment failure among patient
timeFrame: 3 years
measure: Number of the patients who die after treated with antibiotic meropenem in intensive care unit
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01368562: Compassionate Use Study of Methylnaltrexone
Official title: A Compassionate Use Study of Methylnaltrexone in Patients With Opioid-Induced Side Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-induced Constipation
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 26
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: This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.


Eligibility criteria: Inclusion Criteria:

* Advanced medical illness (that is; terminal illness, such as incurable cancer or end stage aqcuired immunodeficiency syndrome \[AIDS\]) with a life expectancy of one to six months.
* On an opioid regimen for the control of pain/discomfort for at least seven days.
* Has opioid-induced constipation.
* Stable vital signs and systolic blood pressure greater than or equal to (\>=) 85 millimeters of mercury (mmHg), and diastolic blood pressure \>=45 mmHg (Supine or sitting).
* Females of childbearing potential must have a negative pregnancy test (serum or urine).
* On a laxative regimen (for example, stool softener and SENNA or equivalent) for at least 3 days prior to treatment. Participants who have discontinued laxatives due to intolerability or lack of efficacy are also eligible.

Exclusion Criteria:

* Participants with known hypersensitivity to methylnaltrexone, naltrexone or naloxone.
* Participants who received any investigational new drug (experimental) except for methylnaltrexone in the previous 30 days.
* Participants who are constipated with a disease process suggestive of gastrointestinal obstruction, impaction or diagnosed with a current abdominal pathologic process which may represent a non-opioid cause of bowel dysfunction.
* Participants who are constipated and have active, clinically significant diverticulitis.
* Participants with a surgically acute abdomen.
* Participants being treated with opioids for diarrhea, dyspnea, cough, pulmonary edema, or congestive heart failure.
* Individuals with a known drug addiction.
* Females who are pregnant or nursing.

Primary outcomes:
measure: Number of Participants With Opioid Induced Side Effects
timeFrame: From start of treatment until end of study (up to maximum 3.4 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Bausch Health Companies
name: Lindsey Mathew
role: STUDY_DIRECTOR
References:
Clinical trial NCT01984762: Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus.
Official title: Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Bariatric Surgery
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is a growing epidemic throughout the world and is followed by increasing incidence of type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major objective, although difficult to achieve with medical treatments. Many recent studies demonstrated that bariatric surgery has the potency to achieve marked and sustained weight loss, and is also associated with a significant improvement in control of type 2 diabetes. The principal aim of this study is to compare two types of bariatric procedures, the Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that these procedures have equal efficacy with regard to resolution of type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes mellitus
2. BMI between 35 and 50kg/m2.
3. Males and females
4. Age between 18 and 60 years.

Exclusion Criteria:

1. Severe ongoing psychiatric disorder, alcoholism and substance abuse.
2. Redo operations after previous bariatric procedures.
3. Type 1 diabetes or other non-type 2 forms of diabetes
4. End stage renal disease, retinopathy, neuropathy

Primary outcomes:
measure: Rate of resolution of type 2 diabetes
timeFrame: 5 years
Secondary outcomes:
measure: postoperative complications
timeFrame: 5 years
Other outcomes:
measure: Glycemic control mechanisms
timeFrame: 5 years
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Göteborg University
name: Lars Fändriks, MD, PhD, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06348862: Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds
Official title: Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds: A Double Blinded Parallel Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
MRI Contrast Media Adverse Reaction
Lead sponsor: Al-Quds University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the current study is to analyze the effect of listening to Quran or music or natural sounds on anxiety and stress level among patients undergoing MRI.

Detailed description: After informed consents will be obtained from patients undergoing Magnetic Resonance Image (MRI). A randomized Controlled Parallel design will be used to assess the effectiveness of listening to Quran, music, and natural sound to reduce anxiety and stress level among patients undergoing MRI in Palestine. A control group will receive the traditional care during MRI without listening to any sound, while the intervention groups will listen to either Quran, music, or natural sounds during the MRI scan. Notice that each patient will choose the preferred method to be in one of the four mentioned groups. This study will include participants with predetermined specific eligibility criteria.

Eligibility criteria: Inclusion Criteria:

* Who agreed to participate in this study.
* Both sex.
* Age of 18 years and above.
* Fully conscious and oriented.

Exclusion Criteria:

* Referrals from the intensive care unit.
* Life-threatening situations.
* General ill health,
* Serious psychological disorders.
* Invasive MR imaging procedures (such as biopsies).
* Being under the age of 18, and
* Exams that were particularly scheduled for other investigations.

Primary outcomes:
measure: Level of Anxiety among patients who underwent MRI
timeFrame: Ten to 30 minutes according to the duration of MRI
measure: Level of Stress
timeFrame: Ten to 30 minutes according to the duration of MRI
Secondary outcomes:
measure: Sociodemographic
timeFrame: Ten to 30 minutes according to the duration of MRI
Other outcomes:
Locations:
city: East Jerusalem
country: Palestinian Territory, occupied
facility: Al-Quds University
state: Jerusalem
Study officials:
References:
Clinical trial NCT02719262: Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention
Official title: Workplace Intervention and Reduced Ambient Melamine Exposure and Renal Damage in Melamine Tableware Manufacturing Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Exposure
Keywords: Melamine
Renal damage
Workplace intervention
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Install local ventilation or not
Primary purpose: PREVENTION

Brief summary: The investigators recent study has found that ambient melamine exposure can cause the increase of biomarkers of renal tubular injury in melamine manufacturing workers. Thus, in this year, the investigators will examine whether the intervention by installing ventilation in the workplace and providing personal protective equipment and education can decrease ambient melamine exposure and further decrease urinary biomarkers of renal tubular injury such as N-acetyl β-D-glucosaminidase (NAG) and β2-microglobulin (β2-MG).

Detailed description: The investigators through intervention trial design to examine whether the use of ventilation in the workplace can decrease ambient melamine exposure, oxidative stress markers (such as 8-hydoxy-2-deoxyguanosine, malondialdehyde)and indicators of early renal damage (such as N-acetyl β-D-glucosaminidase, microalbumin and β2-microglobulin). The one week before intervention and the second week after intervention, the volunteers were asked to collect their urine samples for one consecutive week during mornings and afternoons. Blood samples were taken on Fridays morning, workplace air was sampled for 5 consecutive days. Then the investigators continued to trace the melamine concentration change of volunteers and workplace every three-month intervals after intervention, and blood samples were taken on 12th and 24th month.

Eligibility criteria: Inclusion Criteria:

* healthy adult over age of 20 years

Exclusion Criteria:

* any hormone treatment or major chronic diseases (such as: cancer, hypertension, diabetes, chronic kidney disease and chronic liver disease) and patients with urinary calculi or family history of urinary calculi

Primary outcomes:
measure: Change of melamine in air and in urine
timeFrame: 1 weeks
Secondary outcomes:
measure: Oxidative stress markers 8-hydoxy-2-deoxyguanosine (8-OHdG)
timeFrame: 6 months
measure: oxidative stress markers malondialdehyde (MDA)
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Ming-Tsang Wu, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00102362: Job-Seekers Training for Patients With Drug Dependence - 1
Official title: Job Seekers Training for Patients With Drug Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance-Related Disorders
Keywords: behavioral intervention
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Virginia Commonwealth University
First posted: 2005-01-28
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: The purpose of this study is to examine the effectiveness of a 12-hour basic job-training program designed to give drug abuse treatment patients the skills they need to find and secure a job and set vocational goals and methods for locating employment. The intervention to be evaluated is modeled after the Job Seekers' Workshop, which was manualized and has been tested in trials.


Eligibility criteria: * DSM-IV drug/alcohol abuse/dependence
* enrolled in drug treatment for at least 30 days
* unemployed or underemployed
* expressed interest in employment
* demonstrate English comprehension

Primary outcomes:
measure: Employment or Job Training Program
Secondary outcomes:
Other outcomes:
Locations:
city: Berkely
country: United States
facility: 14th Street Clinic
state: California
city: Baltimore
country: United States
facility: Glenwood Life Counseling Center
state: Maryland
city: Baltimore
country: United States
facility: Man Alive
state: Maryland
city: Baltimore
country: United States
facility: Daybreak Rehabilitation Center
state: Maryland
city: 'Danvers
country: United States
facility: CAB Health and Recovery Services, Inc.
state: Massachusetts
city: Salem
country: United States
facility: CAB Health Recovery-Salem Outpatient
state: Massachusetts
city: Detroit
country: United States
facility: Psychiatry and Behavioral Medicine Professionals I
state: Michigan
city: Detroit
country: United States
facility: Self Help Addiction Rehabilitation (SHAR), Inc.
state: Michigan
city: Gallup
country: United States
facility: Na'nizhoozhi Center, Inc.
state: New Mexico
city: Santa Fe
country: United States
facility: Life Link
state: New Mexico
city: Baker City
country: United States
facility: New Directions, NW
state: Oregon
city: Summerville
country: United States
facility: Dorchester Alcohol and Drug Commission
state: South Carolina
city: Chesterfield
country: United States
facility: Chesterfield County CSB- Substance Abuse Services
state: Virginia
Study officials:
affiliation: Johns Hopkins University
name: Dace Svikis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05420662: The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations
Official title: The Effects of Vaginal Manipulator Use on the Residual Vaginal Length and Operative Outcomes in Abdominal Hysterectomy Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Hysterectomy
Keywords: Vaginal Manipulator
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: If a vaginal manipulator is used for abdominal hysterectomy, the vagina can be cut and separated from the cervix without cutting the Cardinal and Sacrouterine ligaments and protecting the top of the vaginal tissue (Portio vaginalis). In this way, both the shortening of the vagina and the prolapse of the vaginal cuff can be prevented. In addition, the duration of hysterectomy surgery is significantly shortened.

Detailed description: In a classical abdominal hysterectomy, the Cardinal ligaments and the Sacrouterine ligaments are cut before the uterus leaves the vagina, and the vaginal cuff is cut deeper in the vagina over the cervix and separated from the vagina. During this procedure, the vaginal tissue in the Portio vaginalis comes out and causes a loss of vaginal length. If a vaginal manipulator is used for abdominal hysterectomy, the vagina can be cut and separated from the cervix without cutting the Cardinal and Sacrouterine ligaments and protecting the top of the vaginal tissue (Portio vaginalis). In this way, both the shortening of the vagina and the prolapse of the vaginal cuff can be prevented. In addition, the duration of hysterectomy surgery is significantly shortened.

Eligibility criteria: Inclusion Criteria:

* Women who underwent hysterectomy due to abnormal uterine bleeding
* Myoma uteri, little than 5 cm which does not disrupt the uterine anatomy

Exclusion Criteria:

* Myoma uteri, which disrupts the uterine anatomy
* Intra-abdominal adhesions
* Endometrial intraepithelial neoplasia
* Endometrial cancer
* Ovarian cancer
* Cervical cancer

Primary outcomes:
measure: Vaginal Length Difference
timeFrame: Preoperative one hour and postoperative one hour
Secondary outcomes:
measure: Operation time
timeFrame: One to two hours
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Şener Gezer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiyak H, Karacan T, Ozyurek ES, Turkgeldi LS, Kadirogullari P, Seckin KD. Abdominal Hysterectomy with a Uterine Manipulator Minimizes Vaginal Shortening: A Randomized Controlled Trial. J Invest Surg. 2021 Oct;34(10):1052-1058. doi: 10.1080/08941939.2020.1744774. Epub 2020 Apr 2.