louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01203995: Remote Information Counseling for Elders
Official title: Remote Information Counseling for Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to provide testing methods of delivering nutrition and physical activity services for weight loss.


Eligibility criteria: Inclusion Criteria:

1. Aged 40 to 64 years.
2. One or more CHC visits in the past 12 months.
3. Body-mass index of ≥30 and \<50.
4. English speaking.
5. Access to telephone.
6. A permanent address.
7. Willingness to be randomized.
8. Willingness to have computer installed in home.

Exclusion Criteria:

1. Any serious medical condition likely to hinder accurate weight measurement, or for which weight loss is contraindicated or could cause weight loss (e.g., cancer).
2. Current diagnosis of psychosis or bipolar disorder.
3. Unstable or recent onset of cardiovascular disease within 6 months or presence of congestive heart failure
4. Illness that might be associated with weight change, such as asthma (because of treatment with corticosteroids), psychosis
5. Use of medications that might cause weight gain such as hypoglycemic oral medicines or insulin, anti-depressants, and weight loss medications.
6. Unwilling or unable to provide informed consent.
7. Receiving disability insurance.
8. Pregnant or nursing in past 6 months, or plans to become pregnant within 12 months.
9. Enrolled in a weight loss program or study or member of household enrolled in study.
10. Residence outside of Marion County, Indiana.
11. Residence relocation plans within 12 months.
12. Planned or prior bariatric surgery.
13. Substance abuse.
14. History of treatment for eating disorder.
15. Unstable weight with loss or gain of ≥ 5% in last 3 months.

    -

Primary outcomes:
measure: BMI
timeFrame: two months
Secondary outcomes:
measure: 2-Minute Step Test
timeFrame: two months
measure: Chair stand test
timeFrame: 2 month
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: HITS
state: Indiana
Study officials:
affiliation: Indiana University Center for Aging
name: Daniel O Clark, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00293995: Minimal Access Repair of Contralateral Hernias (MARCH Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Inguinal Hernia
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2006-02-20
Enrollment: 360
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of contralateral patent processus vaginalis if present, versus open repair


Eligibility criteria: Inclusion Criteria:

* unilateral inguinal hernia

Exclusion Criteria:

-

Primary outcomes:
measure: development of metachronous contralateral inguinal hernia
timeFrame: Until end of follow-up
Secondary outcomes:
measure: development of recurrent hernia
timeFrame: Until end of follow-up
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Great Ormond Street Hospital
name: Agostino Pierro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03727581: Ultrasound for Guidewire Detection
Official title: Dialysis Catheter Insertion With Substernal Ultrasound Guidance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Acute
Kidney Failure, Chronic
Keywords: hemodialysis
vascular access
dialysis catheter
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute kidney disease or end stage renal disease who need dialysis catheter insertion for hemodialysis performance

Brief summary: The aim of the project is to check if there is a possibility for a nephrologist to visualise the guidewire by means of available ultrasound scanners. To evaluate that, the procedure of catheter insertion will be expanded by ultrasound examination of right atrium and inferior vena cava border using substernal view. Such imaging seems to ameliorate the safety of catheter implementation and could be a good alternative for fluoroscopy, eliminating its adverse effects.


Eligibility criteria: Inclusion Criteria:

* Renal failure requiring hemodialysis through a dialysis catheter
* Capable of giving informed consent
* Placement of internal jugular vein catheter

Exclusion Criteria:

* Inability to provide informed consent
* Poor visualisation of inferior vena cava

Primary outcomes:
measure: Successful guidewire insertion
timeFrame: 5 minutes
measure: Successful catheter placement
timeFrame: 2 hours
Secondary outcomes:
measure: Complication rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Department of Nephrology and Transplantation Medicine
Study officials:
affiliation: Wroclaw Medical University
name: Krzysztof Letachowicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03102281: Microbiomes in Patients of Recurrent Common Bile Duct Stones
Official title: Gastrointestinal Microbiomes in Patients of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy（EST）
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholelithiasis
Choledocholithiasis
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
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: Subjects will be adults with recurrent common bile duct stones.

Brief summary: Bile duct stones is a common biliary tract disease, which is characterized by high morbidity and frequent recurrence. Endoscopic retrograde cholangiopancreatography (ERCP) is an effective therapy for common bile duct stones, and endoscopic sphincterotomy (EST) which associated with recurrent cholangiolithiasis often carried out on difficult intubation or extracting stones, probably due to enhanced reflux of intestinal contents that changes the microenvironment. Patients with cholangiolithiasis were consecutively recruited and their bile was collected intra-operatively for high-throughput experiments. Pyrosequencing of 16S ribosomal RNA gene was performed to characterize the microbiota in the bile and other body fluids. A liquid chromatography mass spectrometry-based method was used to profile bile composition. Clinical manifestation, microbiome, and bile composition were compared between patients with or without recurrent of bile duct stones. The aim of our study was to identify the impact of microbiomes on the recurrent of bile duct stones after ERCP+EST therapy.


Eligibility criteria: Inclusion Criteria:

1. Patients with recurrent common bile duct stones.
2. No antibiotics or probiotics are used for nearly three months.
3. In addition to common bile duct stones, possibly without other digestive diseases.

Exclusion Criteria:

1. Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
2. Pregnant or lactating females.
3. Active Hepatitis B or C or history of an HIV infection.
4. Active uncontrolled infection.
5. Billroth II or roux-en Y gastrointestinal alteration people.

Primary outcomes:
measure: Changes of Bacteria in Body Fluid
timeFrame: 3 years
Secondary outcomes:
measure: Stone diameter
timeFrame: 3 years
measure: EST size
timeFrame: 3 years
measure: Stone type
timeFrame: 3 years
measure: Bile acid composition(Mass spectrometry or Chromatography)
timeFrame: 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
name: Miao Lin, Study Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02362581: Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A
Official title: Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prophylaxis
Hemophilia A
Keywords: Prophylaxis treatment
On demand treatment
Severe hemophilia A
Moderate hemophilia A
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of prophylaxis and on-demand treatment in children with moderate to severe hemophilia A.

This study determines to compare the efficacy of prophylaxis and on-demand treatment in moderate to severe hemophilia A children in King Chulalongkorn Memorial Hospital, Bangkok, Thailand


Eligibility criteria: Inclusion Criteria:

* Age between 6 months to 18 years
* Diagnosis severe and moderate hemophilia A

Exclusion Criteria:

* platelet \< 100,000/mm3
* No factor VIII inhibitor

Primary outcomes:
measure: Number of bleeding episodes require treatment
timeFrame: one year
measure: number of school days lost
timeFrame: one year
measure: Number of admission days
timeFrame: one year
Secondary outcomes:
measure: Joint scores
timeFrame: one year
measure: Quality of life score
timeFrame: one year
measure: Amount of Facter VIII concentration used
timeFrame: one year
Other outcomes:
Locations:
city: Pratumwan
country: Thailand
facility: pediatric Hemato-oncology department, King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: pediatric Hemato-Oncology
name: Darintr Sosothikul, Asso professer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01836081: Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Occlusive Disease
Keywords: fluid responsiveness
carotid artery peak velocity variation
coronary disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to investigate usefulness of the respirophasic variation in carotid artery peak flow velocity measured by Doppler ultrasound, which is noninvasive and easily accessible, as a predictor of fluid responsiveness in patients with coronary artery disease.


Eligibility criteria: Inclusion Criteria:

1. patients scheduled for elective isolated off-pump coronary artery bypass graft surgery

Exclusion Criteria:

1. cardiac rhythm other than sinus
2. congestive heart failure
3. left ventricular ejection fraction \<35%
4. history of transient ischemic attack
5. pre-existing cerebrovascular disease and peripheral arterial occlusive disease
6. presence of carotid artery stenosis \>50%

Primary outcomes:
measure: Predictive power of the respirophasic carotid flow peak velocity variation for the fluid responsiveness
timeFrame: Measurement of respirophasic carotid flow peak velocity variation before the volume expansion
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
citation: Song Y, Kwak YL, Song JW, Kim YJ, Shim JK. Respirophasic carotid artery peak velocity variation as a predictor of fluid responsiveness in mechanically ventilated patients with coronary artery disease. Br J Anaesth. 2014 Jul;113(1):61-6. doi: 10.1093/bja/aeu057. Epub 2014 Apr 9.
Clinical trial NCT01058681: Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction
Official title: Impacts of Metabolic Variation on the Activity of Neuroendocrine Reproductive Axis in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroendocrine Reproductive Status
Keywords: LH pulsatility
GnRH regulation
isocaloric nutrition
hypercaloric nutrition
euglycemic clamps
hyperinsulinemic clamps
testosterone
LH
leptine
ghrelin
PYY
CCK
GLP-1
GIP
cortisol
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the potential effects of a changing metabolic environment on GnRH hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp studies) in different groups of male subjects fed isocaloric and hypercaloric diets. The participation of other gastro-intestinal tract hormones to these regulations will be systematically evaluated.


Eligibility criteria: Inclusion Criteria:

* male
* age between 18 and 25 years old
* no known pathology
* normal physical exam
* BMI between 20 and 25 kg/m2

Exclusion Criteria:

* history of endocrine disease
* no known infertility (no conception after 12 months of regular unprotected intercourse)
* abnormal results on the initial blood tests (CBC, fasting glucose and insulin, HbA1C, TSH, free T4, LH, FSH, inhibin B and total testosterone)

Primary outcomes:
measure: Luteinizing hormone (LH) pulsatility
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUVaudois
Study officials:
affiliation: CHUV
name: François Pralong
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUV
name: Vittorio Giusti
role: STUDY_DIRECTOR
affiliation: CHUV
name: Luc Tappy
role: STUDY_DIRECTOR
affiliation: CHUV
name: Marie-Hélène Pesant
role: STUDY_DIRECTOR
References:
citation: Pesant MH, Dwyer A, Marques Vidal P, Schneiter P, Giusti V, Tappy L, Pralong FP. The lack of effect of insulin on luteinizing hormone pulsatility in healthy male volunteers provides evidence of a sexual dimorphism in the metabolic regulation of reproductive hormones. Am J Clin Nutr. 2012 Aug;96(2):283-8. doi: 10.3945/ajcn.111.030189. Epub 2012 Jul 3.
Clinical trial NCT06256081: Testing a New App for Children With Glue Ear
Official title: Testing the Hear Glue Ear Software Application on Patients With Glue Ear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Conductive
Keywords: glue ear
Lead sponsor: Cambridgeshire Community Services NHS Trust
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Teal of an app
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess whether children with glue ear ( and some normal hearing controls) and their families find the Hear Glue Ear application acceptable and easy to use. Whether the hearing screening section on the app is comparable to the hearing test data obtained from formal audiology hearing tests.

Detailed description: The Hear Glue Ear application aims to provide up-to-date information for families as well as audiobooks, songs and games for children with hearing loss secondary to glue ear, to be able to aid with their developmental skills (particularly speech, language, auditory processing, auditory memory and listening skills) during the period of time when they have glue ear.

Outcome measures include acceptability of the application by the family (provided by questionnaires to the child and an adult parent/ carer), usability of the app (a member of the research team will observe the child using the app and how much difficulty they have such as how many times the researcher has to help/ intervene) and comparison of the hearing screen on the app with formal audiology hearing test result.

Eligibility criteria: Inclusion Criteria:

* aged 2-8 years old
* had a formal hearing test at Cambridge audiology clinic and has a diagnosis of gluem ear worse than 25dB at more than 1 frequency or nornmal hearing diagnosed where 20dB or better is recorded at 0.5, 1, 2, 4 KHz

Exclusion Criteria:

* permanent hearing loss
* English not a dominant language (since the app is written in English)

Primary outcomes:
measure: acceptability of the Hear Glue Ear application to children with glue ear and their families
timeFrame: Observing the child looking at the app for he first time and following up with the family after 1 week from baseline regarding whether they used it at home
Secondary outcomes:
measure: does the hearing screen on the Hear Glue Ear application compare to hearing test results from formal audiology testing.
timeFrame: 1 hour maximum. one appointmnet where the researcher observes the child accessing the app
measure: Ease of use of the Hear Glue ear application
timeFrame: 1 hour. one appointmnet where the researcher observes the child accessing the app
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridgshire Community Services NHS Trust
state: Cambridgshire
Study officials:
affiliation: Cambridgeshire Community Services
name: Tamsin Holland Brown, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03805581: Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
Official title: A Phase II Study to Determine the Safety of Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sickle Cell Disease
Acute Chest Syndrome
Lead sponsor: New York Medical College
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2019-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).


Eligibility criteria: Inclusion Criteria:

* SCD-associated ACS with the presence of any two or more of the following signs not explained by other etiologies: Fever, Chest pain, Cough, Dyspnea, Tachypnea for age, Pulmonary infiltrate on CXR and/or Chest CT scan, Decreased O2 saturation with or without oxygen supplement;
* Age 2 to 40 years of age;
* Homozygous Hemoglobin S Disease, Hemoglobin SC Disease or Hemoglobin S 0/+ thalassemia;
* Informed consent/assent;
* Consent of patient/parent within ≤72 hours after inpatient admission for SCD-associated ACS.
* Females of childbearing age will have a negative pregnancy test.

Exclusion Criteria:

* Current Grade III or IV hemorrhage;
* Previous hypersensitivity reaction to defibrotide;
* Current systemic anti-coagulant therapy and/or fibrinolytic therapy;
* Consent of patient/parent greater than 72 hours of inpatient admission for SCD-associated ACS;
* No signed informed consent

Primary outcomes:
measure: Number of patients with grade III/IV allergic reaction to defibrotide
timeFrame: 30 days
measure: Number of patients with grade III/IV hemorrhage
timeFrame: 30 days
Secondary outcomes:
measure: Number of patients with improvement in clinical signs of Acute Chest Syndrome
timeFrame: 30 days
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Mitchell S Cairo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00809081: Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy
Official title: A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreas Cancer
Bile Duct Cancer
Ampulla of Vater Cancer
Keywords: periampullar carcinoma
Pancreaticoduodenectomy
Enteral feeding
Total Parenteral Support
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-12-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.

1. To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition
2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy

Detailed description: Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. The use of TPN significantly increases postoperative complications, especially those associate with infections. However, method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.

1. To evaluate whether early enteral nutrition may be decreased the postoperative complications
2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
3. To determine the optimal method for postoperative nutritional support

Eligibility criteria: Inclusion Criteria:

* Periampullar carcinoma
* Pancreaticoduonectomy
* KARNOFSKY PERFORMANCE SCALE \> 70
* No history of Major operation

Exclusion Criteria:

* Creatinine level\>3mg/L
* Ascitis/portal hypertension
* New York Heart Association class\>3
* COPD
* Preoperative Radiotheraly/chemotherapy
* Unresectable primary cancer
* Palliative surgery

Primary outcomes:
measure: To evaluate the impact of early postoperative enteral feeding
timeFrame: Postoperative 21 days
Secondary outcomes:
measure: To evaluate the nutritional status
timeFrame: Postoperative 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yongdong Severance Hospital
Study officials:
affiliation: Yonsei University
name: Dong Sup Yoon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: