louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04841837: Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus
Official title: Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Time-restricted feeding
Type 2 diabetes mellitus
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diet management could improve blood and weight control in patients with diabetes mellitus. Time-restricted feeding is a novel dietary tool that limits time of energy intake without altering diet quality or quantity. This study aims to assess the effect of 10-hour time-restricted feeding on metabolism and behavior in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with type 2 diabetes mellitus
2. HbA1c 7.0% to 8.5%
3. BMI ≥ 24 kg/m2
4. Time of energy intake ≥ 12 hours per day, ≥ 4 days per week
5. Ability to use smart phone and app, to follow study protocol
6. Sign informed consent

Exclusion Criteria:

1. Use insulin, long-acting insulin secretagogues, GLP-1 receptor agonist, DPP-4 inhibitor, SGLT-2 inhibitor
2. Suffer from disease influence eating: mental disease, subtotal gastrectomy, inflammatory bowel disease, uncontrolled thyroid disease
3. Work state affect eating time: constant night duty, constant long-haul international travel
4. Smoking
5. Drinking
6. Severe disease: severe cardiovascular and cerebrovascular disease, uncontrolled arrhythmia, heart failure, acute and chronic renal dysfunction, liver cirrhosis, malignancy, anemia
7. Suffered from infectious disease: pulmonary tuberculosis, AIDS
8. Dyskinesia
9. Body weight change ≥ 5 kg in the past 3 months
10. Hospitalized in the past 3 months
11. Used antibiotics for ≥ 3 days in the past 3 months
12. Diagnosed with type 1 diabetes mellitus
13. Pregnancy, lactating
14. Participating in other clinical trials in the past 1 months

Primary outcomes:
measure: HbA1c
timeFrame: through study completion, an average of 12 weeks
measure: Mean blood glucose
timeFrame: through study completion, an average of 12 weeks
measure: Time in range
timeFrame: through study completion, an average of 12 weeks
Secondary outcomes:
measure: Compliance of time-restricted feeding
timeFrame: through study completion, an average of 12 weeks
measure: Adverse event
timeFrame: through study completion, an average of 12 weeks
measure: type and proportion of intestinal flora
timeFrame: through study completion, an average of 12 weeks
measure: Body weight (kg)
timeFrame: through study completion, an average of 12 weeks
measure: Body composition (fat and muscle mass)
timeFrame: through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
Clinical trial NCT02100137: Women With Asymptomatic Endometrial Hyperplasia
Official title: Women With Asymptomatic Endometrial Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Hyperplasia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound

Brief summary: The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia diagnosed using a vaginal ultrasound during routine gynecological examination.


Eligibility criteria: Inclusion Criteria:

* asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound

Exclusion Criteria:

* postmenopausal bleeding

Primary outcomes:
measure: Number of invasive endometrial cancers
timeFrame: Participants will be followed for the duration of hospital and until the results of the final histology from the endometrial biopsy are completed, for an expected average of 10 days
Secondary outcomes:
measure: Number of women with atypical endometrial hyperplasia
timeFrame: Participants will be followed for the duration of hospital and until the results of the final histology from the endometrial biopsy are completed, for an expected average of 10 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Lukas Hefler, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03489837: Phase III Study to Evaluate the Efficacy and Safety of HOB-048 CR Tab. in Comparison With HOB-048 Syrup in Patients With Cough Due to Acute or Chronic Bronchitis
Official title: A Randomized, Double-blind, Multicenter, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis
Lead sponsor: Hyundai Pharm
Sponsor class: INDUSTRY
First posted: 2018-04-06
Enrollment: 272
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, multicenter, active-controlled phase III study to evaluate the efficacy and safety of Levotuss CR tab. in comparison with Levotuss syrup in patients with cough due to acute or chronic bronchitis


Eligibility criteria: Inclusion Criteria:

* moderate, severe, very severe non-productive cough patients

Exclusion Criteria:

* Patients receiving a concomitant therapy

Primary outcomes:
measure: Cough severity check
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Included Seoul national hospital,10sites
Study officials:
References:
Clinical trial NCT04276337: Genetic Characteristics of HER2 Positive Breast Cancer With Neoadjuvant TCHP Chemotherapy
Official title: Genetic Characteristics of HER2 Positive Breast Cancer Receiving Neoadjuvant Chemotherapy With Docetaxel, Carboplatin, Trastuzumab and Pertuzumab (TCHP) Regimen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HER2-positive Breast Cancer
Chemotherapy Effect
Circulating Tumor DNA
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced HER2 positive breast cancer receiving neoadjuvant chemotherapy with docetaxel, carboplatin, trastuzumab and pertuzumab (TCHP) regimen

Brief summary: Locally advanced breast cancer (LABC) is defined as breast cancer (BC) larger than 5 centimeters or with lymph node metastasis. Usually, LABC is treated with neoadjuvant chemotherapy (NAC) followed by curative surgery to reduce tumor size and eliminate micrometastasis. Response to NAC helps predict BC prognosis. Pathologic complete response (pCR), defined as no residual tumor cells after NAC, represents prolonged survival without BC recurrence and residual cancer burden score, based on residual tumor volume, and can more accurately predict BC outcomes. Especially, Human epidermal growth factor receptoor type 2(HER2)-positive breast cancer, having aggressive biologic characteristics, was mostly treated by NAC because of recent advance of highly effective targeted agents (pertuzumab and trastuzumab). However, still 30-40% of HER2-positive breast cancer did not response to NAC and underwent disease recurrence. Recently, genetic studies to find biomarker of BC prognosis have been widely performed. Circulating tumor DNA (ctDNA), which is circulating free DNA in the blood that originates from cancers, can be detected by recently-developed technologies. CtDNA could facilitate early disease detection, diagnosis and detection of disease recurrence. CtDNA also provides a genomic profile of BC and predicts drug response. In BC, ctDNA correlates with tumor burden and provides early detection of treatment response and tumor genetic alterations.

In this study, the investigator aimed to identify the correlations in genomic profile between tumors and ctDNA during NAC(docetaxel /carboplatin /trastuzumab and pertuzumab) in HER2 positive breast cancer.


Eligibility criteria: Inclusion Criteria:

* HER2+ Breast cancer
* Stage IIA - IIIC
* Plan to receive neoadjuvant chemotherapy with docetaxel, carboplatin, herceptin, perjeta
* Sign to informed consent

Exclusion Criteria:

* Double primary cancer

Primary outcomes:
measure: pathologic complete response
timeFrame: Pathologic Clinical response is performed after end of cycle 6 (each cycle is 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01896037: Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels
Official title: Omega-3 Supplementation to Increase HDL-c Levels in Those With Tetraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Cord Injury
Tetraplegia
Quadraplegia
Low HDL-c
High LDL-c
Keywords: Spinal cord injury
Tetraplegia
Quadraplegia
Cholesterol
HDL-c
LDL-c
Omega-3 fatty acids
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: The Association of Rehabilitation Medicine in Manitoba
First posted: 2013-07-11
Enrollment: 21
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: People with a spinal cord injury (SCI) characteristically have low levels of high-density lipoprotein-cholesterol (HDL-c; "good cholesterol") and high levels of low-density lipoprotein-cholesterol (LDL-c; "bad cholesterol"), and are at a higher risk of developing cardiovascular health problems, such as heart disease, heart attack and stroke, than the able-bodied population. A common way for able-bodied people to improve their lipid profile is through exercise; however, SCI people, especially tetraplegics, are often unable to achieve and maintain a level of exercise needed to obtain these benefits. It is therefore clinically important to find an effective, safe and inexpensive method of increasing HDL-c levels in people with chronic tetraplegia. This study will investigate the effects of omega-3 fatty acid supplementation on the lipid profile of people with tetraplegia. The investigators hypothesize that 5 months of daily consumption of high doses of omega-3 fatty acids will increase plasma levels of HDL-c in those with tetraplegia, leading to decreased risk of cardiovascular health issues.


Eligibility criteria: Inclusion Criteria:

* Having chronic tetraplegia (at least on year since injury)
* 18 years or older
* Having below normal fasting blood plasma levels of HDL-c (\<1 mmol/l)

Exclusion Criteria:

* Currently taking omega-3 supplements
* Currently taking medications for abnormal cholesterol
* Having a heart attack or stroke in the past one year

Primary outcomes:
measure: Blood plasma levels of HDL-cholesterol
timeFrame: Month 5
Secondary outcomes:
measure: Blood plasma levels of total cholesterol
timeFrame: Month 5
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Karen Ethans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04050137: Therapeutic Exercise to Treat Neuropathic Pain
Official title: Therapeutic Exercise to Treat Neuropathic Pain in Patients With Chronic Lisosomal Injuries: Learning and Service Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gaucher Disease
Fabry Disease
Keywords: Gaucher Disease
Exercise
Terapheutic
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: fundación española para el estudio y tratamiento de la Enfermedad de Gaucher y otras lisosomales
name: Fundación San Valero
name: Fundación Ibercaja
First posted: 2019-08-08
Enrollment: 5
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A quasi-experimental, prospective clinical trial with pre and post intervention measurements, whose porpuose is assess the efficacy of a therapeutic exercise protocol to treat neuropathic pain in Fabry Disease.

Detailed description: There take part in this study women or men aged between 18 and 65 years, with a diagnosys by a physician specializing in Fabry disease with FabryScan. Patients must present a stable evolution, with a scoring system of disease severity (DS3) that must be less than 8 points per year in the last 2-3 years and they have to presence of neuropathic pain with a score greater than or equal to 4 in the questionnaire "Douleur neuropathique (DN4)".

Eligibility criteria: Inclusion criteria:

* Female or male patients between 18 years and 65 years.
* Patients diagnosed by a doctor specializing in Fabry disease with FabryScan.
* Fabry's disease must have a stable evolution, with a disease severity scoring system (DS3) that must be less than 8 points per year in the last 2-3 years.
* Presence of neuropathic pain with a score greater than or equal to 4 in the "Douleur neuropathique (DN4)" questionnaire.

Exclusion criteria:

* Patients with an acute cardiovascular disease or with a heart or kidney transplant.
* Subjects with acute orthopedic problems that limit their participation in the study.
* Subjects with cognitive impairments that prevent them from filling in the questionnaires or understanding the exercises to be performed.

Primary outcomes:
measure: Neurophatic pain
timeFrame: 8 weeks
Secondary outcomes:
measure: Functionality
timeFrame: 8 weeks
measure: Legs' strenght
timeFrame: 8 weeks
measure: Strenght of the extensor muscless of the trunk
timeFrame: 8 weeks
measure: Strenght of the inclination muscless of the trunk
timeFrame: 8 weeks
measure: Strenght of the flexor muscless of the trunk
timeFrame: 8 weeks
measure: Visual Analogue Scale
timeFrame: 8 weeks
measure: Hospital, anxiety and depression questionnaire
timeFrame: 8 weeks
measure: SF-36
timeFrame: 8 weeks
measure: Semmes Weinstein monofilament test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: FEETEG
Study officials:
affiliation: Universidad San Jorge
name: Royo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172237: Proprioception and Eye-head Coordination for the Cervical Spine
Official title: Proprioception and Eye-head Coordination for the Cervical Spine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Diseases
Keywords: eye-head coordination
proprioception
cervical spine with degenerative disease
degenerated cervical spine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 45-64 year-old healthy adults and adults with neck pain

Brief summary: Specific aims of this project were as follows:

1. To investigate the eye-head coordination of patients with cervical spine degeneration.
2. To investigate the relationship of these impairment measurements (range of motion, muscle power, proprioception, sensory threshold, eye-head coordination) and functional outcome (neck disability index, quality of life evaluation).
3. To develop a computer assistant device and software for the proprioceptive training and eye-head coordination.
4. To provide a treatment and prevention program emphasized on proprioception treatment and coordination for employee with neck-shoulder complaints.


Eligibility criteria: Inclusion Criteria:

* Group one: participants without degenerated disease in cervical spine
* Group two: participants with degenerated disease in cervical spine

Exclusion Criteria:

* Grade III, IV degenerated cervical spine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, National Taiwan University
name: Shwu-Fen Wang, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00653237: Laryngeal Mask Supreme™ Versus the I-gel™
Official title: A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Elective General Anesthesia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.

Detailed description: The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference

Eligibility criteria: Inclusion Criteria:

* ASA 1-3 patients undergoing elective operation

Exclusion Criteria:

* Not speaking german or refusing to participate
* BMI \>35, \<50kg
* Planned operation time \>4h
* High risk of aspiration
* Cervical spine disease, known difficult airway, mouth opening \<20mm
* Upper respiratory tract symptoms in the previous 10 days
* Preoperative sore throat
* Poor dentition with high risk of damage

Primary outcomes:
measure: first attempt success rate and time to success
timeFrame: during intervention
Secondary outcomes:
measure: leak pressure
timeFrame: during intervention
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: University Hospital
Study officials:
affiliation: Department of Anesthesia, University Hospital Berne, Switzerland
name: Robert Greif, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00082537: MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)
Official title: A Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus (Amphotericin B) Liposome for Injection as Empirical Therapy in Pediatric Patients With Persistent Fever and Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neutropenia
Fever
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.


Eligibility criteria: Inclusion Criteria:

* Patients who are 2 through 17 years of age
* Absolute Neutrophil Count (ANC) is below 500/microliter
* Have persistent fever (at least 4 days) despite antibiotic therapy

Primary outcomes:
measure: To estimate the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy
Secondary outcomes:
measure: Proportion of patients with a favorable overall response
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Maertens JA, Madero L, Reilly AF, Lehrnbecher T, Groll AH, Jafri HS, Green M, Nania JJ, Bourque MR, Wise BA, Strohmaier KM, Taylor AF, Kartsonis NA, Chow JW, Arndt CA, DePauw BE, Walsh TJ; Caspofungin Pediatric Study Group. A randomized, double-blind, multicenter study of caspofungin versus liposomal amphotericin B for empiric antifungal therapy in pediatric patients with persistent fever and neutropenia. Pediatr Infect Dis J. 2010 May;29(5):415-20. doi: 10.1097/INF.0b013e3181da2171.