louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05022680: The Effects of Peer-led Walking Intervention With mHealth Technology
Official title: The Effects of Peer-led Walking Intervention With mHealth Technology for Physical Activity and Prenatal Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: mHealth Intervention
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomize control trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will apply the peer-led walking intervention with mHealth technology to maintain physical activity and promote prenatal health. Moreover, the participants of the trained peer mentors support women walking with mHealth technology, which has pregnant women using the APP to set goals, self-monitor, and self-manage, and it will continue to promote physical activity for overweight and obese pregnant women

Detailed description: This study was to investigate the effectiveness of peer-led walking intervention with mHealth technology on physical activity, self-efficacy, weekly steps, exercise involvement and depression status. Participants of the trained peer mentors encourage women walking with mHealth technology, which has pregnant women using the APP to set goals, self-record, and self-monitor, and it will continue to promote physical activity for overweight and obese pregnant women.This study's results will be useful to healthcare providers who need to promote physical exercise and an active lifestyle for overweight and obese pregnant women.

Eligibility criteria: Inclusion Criteria:

* women who had a pre-pregnancy body mass index of more than 25 kg/m2

Exclusion Criteria:

-

Primary outcomes:
measure: physical activity
timeFrame: throughout childbirth, average of 20-30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Nursing
Study officials:
affiliation: Mackay Medical College
name: Ching-Fang Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00771680: Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes
Official title: Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 10408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both genders who, in practice settings, have been deemed appropriate to receive Levemir®, NovoMix® 30 or and/or NovoRapid® as new treatment and as part of routine out-patient care by the prescribing physician.

Brief summary: This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

Exclusion Criteria:

* In accordance with approved label

Primary outcomes:
measure: HbA1c
timeFrame: at baseline visit and during 3, 6, 9 and 12 months
measure: Serious adverse drug reactions including major hypoglycaemic events
timeFrame: during 12 months of treatment
Secondary outcomes:
measure: Number of serious adverse drug reactions
timeFrame: during 12 months of treatment
measure: Number of all major (daytime and nocturnal) hypoglycaemic events
timeFrame: during 12 months of treatment
measure: Number of all minor (daytime and nocturnal) hypoglycaemic events
timeFrame: During 4 weeks prior to each study visit
measure: Weight (BMI) change
timeFrame: At 6 and 12 months
measure: Variability in fasting blood glucose values and average (mean) fasting blood glucose level
timeFrame: At baseline visit and after 6 and 12 months treatment
measure: Average post-prandial blood glucose level (2h after dinner)
timeFrame: At baseline visit and after 6 and 12 months treatment
measure: Quality of Life (QoL) as assessed by patient questionnaire
timeFrame: At baseline and the end of 6 and 12 months treatment
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Kiev
country: Ukraine
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06119880: The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy
Official title: The Effect of PERT on Postoperative Complications and Physiological Status in Patients Undergoing Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pancreatic Exocrine Insufficiency
Pancreatic Enzyme Replacement Therapy
Pancreaticoduodenectomy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 100
Sex: ALL
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: A comprehensive perioperative nutrition management plan for pancreaticoduodenectomy, primarily based on pancreatic enzyme replacement therapy (PERT). A prospective randomized controlled study was conducted to comprehensively analyze the perioperative nutritional status of patients undergoing pancreaticoduodenectomy, with the aim of exploring:

1. The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy;
2. The efficacy of PERT treatment on clinical symptoms, nutritional indicators, and quality of life (QOL) related to pancreatic exocrine dysfunction (PEI) after pancreaticoduodenectomy;
3. The personalized full process nutrition management strategies based on risk factor stratification.


Eligibility criteria: Inclusion Criteria:

* Gender unlimited, 18-80 years old;
* Patients undergoing pancreaticoduodenectomy due to various benign or malignant diseases;
* Voluntary testing with informed consent.

Exclusion Criteria:

* Pregnant women and lactating women
* Patients with distant metastasis based on tumor staging before surgery;
* Tumor recurrence;
* Refuse to sign the consent form.

Primary outcomes:
measure: Abdominal Skeletal Muscle Index (SMI)
timeFrame: 8 weeks post-operation
Secondary outcomes:
measure: Postoperative complications
timeFrame: 8 weeks post-operation
measure: Nutritional indicators
timeFrame: 8 weeks post-operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00847080: Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism
Official title: Treatment With Sitagliptin Phosphate in Patients With Reactive Hypoglycemia Secondary to Dysinsulinism. A Controlled, Randomized, Double-blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Reactive Hypoglycemia
Keywords: Reactive hypoglycemia
Sitagliptin
Glucagon-Like Peptide 1
Incretins
Prediabetes
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether sitagliptin is effective in the treatment of reactive hypoglycemia by dysinsulinism.

Detailed description: Symptomatic reactive hypoglycemia is an abnormal glucose decrease after meal ingestion. Patients with this abnormality as an early manifestation of glucose intolerance are at higher risk of type 2 diabetes. The pathophysiology of this abnormality appears to be related with delayed first phase insulin release. Improvement of first phase insulin secretion and delay in gastric emptying induced by sitagliptin phosphate could have favorable effects in patients in whom delayed insulin secretion is associated with reactive hypoglycemia.

Eligibility criteria: Inclusion Criteria:

* Clinical and biochemical diagnosis of prediabetic reactive hypoglycemia
* Must be able to swallow tablet
* Negative pregnancy test (when appropriate)

Exclusion Criteria:

* Renal insufficiency
* Hepatic insufficiency
* Diabetes (any type)

Primary outcomes:
measure: Clinical improvement assessed by a validated questionnaire
timeFrame: 2 weeks
Secondary outcomes:
measure: Glucose, insulin, GLP1, GIP
timeFrame: First and last evaluations
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DF
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Francisco J Gomez-Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02288780: Transthoracic Echocardiographic Evaluation of the Cardiac Function During Transurethral Resection of Prostate in Elderly Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: BPH
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 2
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BPH patients with/without preoperative diastolic dysfunction

Brief summary: Transurethral resection of the prostate (TURP) is a standard surgical treatment for benign prostatic hyperplasia (BPH). Non-conductive irrigation fluid is used to maintain good visibility of the operating field during resection of the prostate. Absorption of this hypotonic solution into the bloodstream can cause fluid overload and dilutional hyponatremia, resulting in adverse cardiovascular and central nervous system effects, transurethral resection (TUR) syndrome. BPH is common in elderly men above 60 years old. These aged people commonly have diastolic impairment by normal physiologic change without consistent symptom. This study aimed to evaluate the cardiac function focused mainly diastolic function during TURP with transthoracic echocardiography. Also, we will focus the effets of amount of irrgation fluid on left ventricular diastolic function in patients with pre-existing diastolic dysfunction.


Eligibility criteria: Inclusion Criteria:

1. Above 65years of age
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. undergoing transurethral resection of the prostate(TURP)"

Exclusion Criteria:

1. severe coagulopathy or bleeding disorder(platelet count\<75000, PT INR \>1.2)
2. short stature (under 150 cm)
3. underwent coronary artery bypass graft
4. contraindications of regional anesthesia "

Primary outcomes:
measure: diastolic function by TTE
timeFrame: The participants will be followed for the duration of surgery (TURP), an expected average of 1 hour.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00571480: Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy
Official title: Acupuncture and Low Back Pain During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related Low Back Pain
Keywords: auricular acupuncture
pregnancy related low back pain
acupuncture
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 159
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ear acupuncture can be used as a treatment for pregnancy induced low back pain.

Detailed description: Ear acupuncture has been used as treatment for various pain symptoms. Pregnancy related low back pain can be debilitating for pregnant women but there is lack of effective treatment. Owing to the unique circulation system between mother and fetus, prenatal care providers and gravidae are reluctant to prescribe or accept the pharmacological intervention. Thus the goal of this clinical investigation is to determine whether ear acupuncture can be used as treatment for this special clinical entity. The participants are randomized into one of the three interventions based on a computer generated randomization table. These three interventions groups are: (1) True acupuncture (2) Sham acupuncture and (3) no acupuncture. All participants are allowed to use standard of care (SOC) as a rescue treatment and the SOC consists of acetaminophen 650 mg every 6 hours no more than 4 times per day, frequent rest and topical warm/cold compress. The participants in group 1 \& 2 received a total of three continuous retained ear acupuncture needles at three sites ipsilateral to the dominant hand in preselected ear acupuncture points for one week then after day 7. All participants are followed/observed for a total 2 weeks after the initiation of the study.

Eligibility criteria: Inclusion Criteria:

* English speaking, healthy pregnant women in at least 25 weeks of gestational age who suffered from low back pain related to pregnancy.
* No obstetric complications during pregnancy or neurological complications that require immediate medical/surgical intervention.

Exclusion Criteria:

* Non-English speaking
* Mentally challenged
* State of pregnancy less than 25 weeks but suffer from pregnancy related low back pain
* Pregnant women without low back pain
* The pregnancy is complicated by obstetrical problems, or low back pain requiring immediate surgical/medical intervention.

Primary outcomes:
measure: severity pain
timeFrame: two weeks
Secondary outcomes:
measure: daily disability index
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Shu-Ming Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03391180: The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances
Official title: The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: White Spot Lesion
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of ICON on White spot lesions compared to CPP-ACPF plus.

Detailed description: The participants were categorized to either group (group1) receiving ICON treatment method (Icon, DMG, Germany), or (group 2) who shall be receiving CPP-ACPF treatment method (Tooth Mousse plus).

Eligibility criteria: Inclusion Criteria:

* permanent dentition, in good general health and without systemic diseases, who had received fixed orthodontic treatment.

Exclusion Criteria:

* Patients with primary dentition, enamel hypoplasia, dental fluorosis or tetracycline pigmentation and carious cavity were excluded.

Primary outcomes:
measure: Remineralization
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Colleges of Dentistry and Pharmacy
state: ArRiyadh
Study officials:
affiliation: Riyadh Colleges of Dentistry and Pharmacy
name: Omar H AlKadhi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00806780: Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy
Official title: Is There a Role for Routine Intraoperative Cholangiography During Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Stones
Keywords: gallstones
cholangiography
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess whether routine imaging of the biliary system during routine gallbladder surgery alters clinical outcome


Eligibility criteria: Inclusion Criteria:

* all patients over the age of 18 with biliary colic or cholecystitis

Exclusion Criteria:

* any history of allergic reaction to contrast material
* patients with abnormal liver function test results
* any clinical history of jaundice
* patients with a history of pancreatitis
* patients with a history of previous ERCP
* patients whose ultrasound showed common bile duct or intra-hepatic duct dilation
* all patients with previous major upper abdominal surgery
* all patients with acalculous cholecystitis or gallbladder polyps

Primary outcomes:
measure: incidence of stones in common bile duct
timeFrame: at surgery
Secondary outcomes:
measure: post-operative complications
timeFrame: one year
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Hampshire
Study officials:
References:
citation: Khan OA, Balaji S, Branagan G, Bennett DH, Davies N. Randomized clinical trial of routine on-table cholangiography during laparoscopic cholecystectomy. Br J Surg. 2011 Mar;98(3):362-7. doi: 10.1002/bjs.7356. Epub 2010 Nov 24.
Clinical trial NCT01603680: Distribution Circumferential Versus Non Circumferential of Mepivacaine in the Median and Ulnar Nerves
Official title: Circumferential Versus Not Circumferential Distribution of Mepivacaine Around the Median and Ulnar Nerves in the Carpal Tunnel Surgery. Randomized Clinical Trial, Double Blinded.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Ultrasonography
Block nerve
Anaesthesia
Carpal tunnel syndrome
Lead sponsor: Complexo Hospitalario Universitario de A Coruña
Sponsor class: OTHER
First posted: 2012-05-22
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. Evaluation of the efficacy of the circumferential versus non circumferential distribution of mepivacaine around the median and ulnar nerves.
2. Evaluation the onset of action of mepivacaine in circumferential versus non circumferential distribution around the median and ulnar nerves.
3. Spread of mepivacaine after injection guided by ultrasonography.
4. Complications of both anesthetic techniques in postoperative time.


Eligibility criteria: Inclusion Criteria:

* Scheduled patients for surgery of carpal tunnel including patients in ASA I-III status, without exclusion criteria. The principal investigator study and/or other designated site staff will obtain written informed consent from all research patients.

Exclusion Criteria:

* Abnormal bleeding, infection in the punction side, allergy or other problems with the medication of the study, muscular or nerve diseases, patients \< 18 years old, pregnancy, cognitive disease or reject of the patient

Primary outcomes:
measure: Efficacy and onset of action
timeFrame: On arrival in the recovery room
Secondary outcomes:
measure: Complications in postoperative time
timeFrame: 24 hours postoperative time
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña. Hospital Abente y Lago
Study officials:
affiliation: Complexo Hospitalario Universitario A Coruña
name: Paula Diéguez, Anesthetist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Nasser B, Hubert C, Negre M. Role of local anesthetic spread pattern and electrical stimulation in ultrasound-guided musculocutaneous nerve block. J Clin Anesth. 2010 Aug;22(5):334-9. doi: 10.1016/j.jclinane.2009.09.008.
citation: Morau D, Levy F, Bringuier S, Biboulet P, Choquet O, Kassim M, Bernard N, Capdevila X. Ultrasound-guided evaluation of the local anesthetic spread parameters required for a rapid surgical popliteal sciatic nerve block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):559-64. doi: 10.1097/AAP.0b013e3181fa6b60.
citation: Dieguez-Garcia P, Lopez-Alvarez S, Juncal J, Lopez AM, Sala-Blanch X. Comparison of the effectiveness of circumferential versus non-circumferential spread in median and ulnar nerve blocks. A double-blind randomized clinical trial. Reg Anesth Pain Med. 2020 May;45(5):362-366. doi: 10.1136/rapm-2019-101157. Epub 2020 Mar 11.
Clinical trial NCT03586180: Medical Clowning: Needs Assessment and Implication for Hospitalized Children With Cancer/Blood Disease
Official title: Medical Clowning: Needs Assessment, Implication, and Evaluation for Children and Adolescents With Cancer Using Child Friendly Healthcare
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Disease
Cancer
Friendly Healthcare in Children
Medical Clown
Hospitalized Children
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease

Brief summary: Hospitalized children who undergo painful procedures are more susceptible than others to experiencing iatrogenic effects, such as anxiety, pain, and severe stress. Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures. This article provides an overview of clowning in health care settings; reviews major studies conducted on clowning for hospitalized children, discussing evidence that clown interventions decrease pain and distress in pediatric patients; and concludes with a discussion of health care clowning as a profession.


Eligibility criteria: Inclusion Criteria:

* aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease

Exclusion Criteria:

* older than aged 18

Primary outcomes:
measure: experience and influence from medical clowning for children and their parents
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Universtiy Hospital
Study officials:
References: