louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00661856: Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices
Official title: The Effect of Increased Soy Protein Intake on Bone Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Soy Isoflavones, Bone Mineral Density, Post menopausal women
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Solae, LLC
First posted: 2008-04-21
Enrollment: 203
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to investigate the effects of soy and soy plus isoflavones on bone mineral Density and physical performance in post menopausal women.

Detailed description: Post menopausal estrogen deficiency causes physiologic changes in body composition including decreased lean body weight and bone mass. A decrease in muscle strength along with osteoporosis puts post menopausal women at a high risk of hip fractures causing considerable mortality and morbidity. Estrogen use has been shown to reduce bone density loss and increase muscle strength but given the concerns regarding its use, patients are looking for alternatives such as Soy isoflavones. Most human studies on the effect of Soy on bone mineral density (BMD) in post menopausal women have been short term i.e. 3-6 months and failed to provide conclusive evidence. There is no evidence of its effects on physical performance.

The aim of the present study is to investigate the effects of 25g of soy protein alone or with 90mg of isoflavones on bone mineral Density and physical performance indices in post menopausal women over a duration of 2 years.

Eligibility criteria: Inclusion Criteria:

* at least 55-75 years of age
* at least 7 years post menopausal either spontaneous or surgical

Exclusion Criteria:

* must not have used estrogen for atleast 2 months prior to entering study
* must be on no bone active drugs such as bisphosphonates, anti convulsants, calcitonin and long term steroids
* osteoporosis (T-score\<-2.5)
* BMI \<18 or \>34

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 24 months
Secondary outcomes:
measure: Physical Performance Indices
timeFrame: 24 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University Medical Center
name: J C Gallagher
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallagher JC, Satpathy R, Rafferty K, Haynatzka V. The effect of soy protein isolate on bone metabolism. Menopause. 2004 May-Jun;11(3):290-8. doi: 10.1097/01.gme.0000097845.95550.71.
Clinical trial NCT00842556: Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
Official title: Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-02-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)


Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2

Exclusion Criteria:

* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
* Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
* History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
* History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related compounds
* Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1
* History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections

Primary outcomes:
measure: Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
timeFrame: 72 hours after dosing
Secondary outcomes:
measure: To assess the safety and tolerability in healthy subjects
timeFrame: 15 time points up to 72 hours after dosing
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01996956: Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Responsiveness
Keywords: stroke volume variation,
cardiac output,
fluid responsiveness,
noninvasive cardiac output monitor
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* congenital cardiac surgery
* \< 6 years old
* who were required the evaluation by transesophageal echocardiography

Exclusion Criteria:

* right heart failure
* supported by more than 2 inotropic agents
* reduced kidney function
* any valvar stenosis
* moderate or severe tricuspid regurgitation
* single ventricle

Primary outcomes:
measure: stroke volume index
timeFrame: before and after volume loading (20 min)
Secondary outcomes:
measure: Cardiac index
timeFrame: before and after fluid loading (20 min)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: Lee JH, No HJ, Song IK, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness using a non-invasive cardiac output monitor in children undergoing cardiac surgery. Br J Anaesth. 2015 Jul;115(1):38-44. doi: 10.1093/bja/aev109. Epub 2015 Apr 29.
Clinical trial NCT04717856: Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA
Official title: Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA Using a Finger Prick; a Cross-sectional, Multicentre Study Among Drug Users
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Use
Hepatitis C
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The results of the GX device are equivalent to standard venous blood sampling. With this study we are going to determine the prevalence in drug users with difficult venous access. On the other hand, we want to look at the place this device can have in primary care.


Eligibility criteria: Inclusion Criteria:

* Have recently or ever used drugs
* Older than 18 years
* Written informed consent

Exclusion Criteria:

* Not being able to speak the Dutch language

Primary outcomes:
measure: Questionaire to determine the satisfaction of the use of the GenXpert
timeFrame: baseline
Secondary outcomes:
measure: The detection of HCV RNA
timeFrame: Baseline
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
Study officials:
References:
Clinical trial NCT02418156: A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
Official title: A Post Market Observational Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Disease
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-16
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for femoral arterial reconstruction with patch angioplasty.

Brief summary: To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.

Detailed description: OBJECTIVE The objective of the study is to actively gather additional information on the use of CorMatrix ECM for vascular repair in the reconstruction of the femoral artery. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure
2. Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use
3. Subject possesses ability to provide informed consent
4. Subject expresses understanding and willingness to fulfill all expected requirements of protocol

Exclusion Criteria:

1. Known sensitivity to porcine material

Primary outcomes:
measure: Device-Related Adverse Events
timeFrame: Up to 12 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05031156: Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration
Official title: Effect of Mandibular Immediately Loaded, Screw-retained Splinted and Non-splinted OT Bridge Implant Restoration on Bone Height Changes of Completely Edentulous Patients (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge System
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of Bone level changes around dental implants in All on 4 cases with immediate loading using conversion denture and OT Bridge system either splinted or not


Eligibility criteria: Inclusion Criteria:

* Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
* Patients aged from 40 to 70, able to sign an informed consent will be considered eligible for this trial.
* Implant sites must allow the placement of four implants.
* Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
* In case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study.
* Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)

Exclusion Criteria:

* - Patients with poor oral hygiene and motivation.
* Pregnancy or nursing.
* Drug abusers.
* Psychiatric problems or unrealistic expectations.
* Patients with infection and or inflammation in the area intended for implant placement.
* Patients participating in other studies, if the present protocol cannot be properly adhered to.
* Patients with signs of hyperactive muscles.

Primary outcomes:
measure: Marginal Bone loss
timeFrame: 3 monts
Secondary outcomes:
measure: Early implant failure
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Tasneem El Mashad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05995756: Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring
Official title: Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 or Type 2 Diabetes
Lead sponsor: Sinocare
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (Aged ≥18) TD1 and TD2

Brief summary: From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation \[SD\] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and analyzed using the YSI 2300 STAT Plus Glucose \& Lactate Analyzer (Yellow Springs Instrument, YSI Life Sciences, Yellow Springs, OH).


Eligibility criteria: Inclusion Criteria:

1. Aged ≥18 years, male or female;
2. Clinically diagnosed with diabetes;
3. Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring;
4. Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).

Exclusion Criteria:

1. Disagree to wear the investigational device continuously according to the requirements of the trial;
2. Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial;
3. Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;
4. With diffuse subcutaneous nodules at the wearing site of the investigational device;
5. Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening;
6. With mental disorders, lack of self-control and inability to express clearly;
7. Have participated in any other clinical trial within the past 1 month;
8. Where the investigator thinks not suitable for being enrolled.

Primary outcomes:
measure: overall mean absolute relative difference (MARD)
timeFrame: 8 or 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
Study officials:
References:
Clinical trial NCT05794256: Genderspecific Differences in Hormone Levels After Trauma
Official title: A Prospective Analysis of the Gender Specific Role of Steroid Hormones on the Outcome on Patients After Polytrauma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polytrauma
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients suffering from severe trauma (ISS ≥ 16) or severe traumatic brain injury (AIS ≥3) will be enrolled in this study.

Brief summary: The goal of this prospective study with the aim to establish a registry is to learn about the role of steroid hormones in severely injured patients. The main question it aims to answer is whether steroid hormones influence morbidity and mortality after severe trauma.

This is a prospective study with the aim to establish a large registry for severely injured patients and their hormonal status.

Hormone levels will be measured upon arrival in the emergency room and within the following few days after trauma. Furthermore a detailed questionnaire aims to answer any hormone-related health questions.


Eligibility criteria: Inclusion Criteria:

* Polytrauma with ISS≥16,
* severe traumatic brain injury (AIS ≥3)
* over the age of 18
* must reach emergency room alive

Exclusion Criteria:

* pregnant patients
* dead on arrival to the hospital
* incarcerated patients
* secondarily transferred patients

Primary outcomes:
measure: Mortality
timeFrame: within 1 year after trauma
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Technical University Munich
state: Bavaria
Study officials:
References:
Clinical trial NCT03590756: Influence of Mango Intake of Skin Health in Postmenopausal Women
Official title: Influence of Mango Intake on Skin Health in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Skin Red
Keywords: Skin Health
Skin Wrinkle
Skin Redness
Carotenoid
Mango
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Mango Board
First posted: 2018-07-18
Enrollment: 36
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate the effects on 16 weeks of mango intake on skin health in postmenopausal women. Half of the participants will receive 85g portions of mangoes while the other half receive 250g portions of mangos. Participants will be instructed to consume the specific portion 4 times a week, for a total duration of 16 weeks.

Detailed description: Mangoes are rich in carotenoids, flavonoids, vitamins and other active phytochemicals such as resistant starches. Although a role of mangoes in skin health has long been advocated in traditional medicine, little scientific research has been conducted.

We hypothesize that 85g (0.5 cups) of mango intake for 16 weeks will have minimal impact on skin health, while 250g (1.5 cups) of mango intake will produce significant benefits.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal
* Fitzpatrick skin type I and II
* BMI 18.5 - 35.0 kg/m2
* Normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician

Exclusion Criteria:

* Allergic to mangoes
* Fruit consumption of 2 or more cups per day
* Vegetable consumption of 3 or more cups per day for females
* Fruit juice consumption of more than 1 cup per day
* Self-reported malabsorption
* Currently taking regular prescription drugs i.e. statins, thyroid, anti-inflammatory drugs
* Had any medical or cosmetic procedures such as laser resurfacing or plastic surgery to the face within the last 6 months, including botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
* Autoimmune photosensitive condition or known genetic condition with a deficiency in collagen production (such as Ehler-Danlos)
* Smoking (current smoker, smoked within the past year, former smokers with greater than a 20 pack-year history of smoking within the past 20 years.
* Indications of substance or alcohol abuse
* Unwillingness to discontinue high antioxidant supplements during washout and interventions

Primary outcomes:
measure: Skin Wrinkle Depth and Redness
timeFrame: 0, 8, and 16 week
measure: Skin carotenoid
timeFrame: 0, 4, 8, 12, and 16 weeks
Secondary outcomes:
measure: Sebum
timeFrame: 0, 8, 16, weeks
measure: Plasma carotenoid
timeFrame: 0, 8, 16 weeks.
Other outcomes:
Locations:
city: Davis
country: United States
facility: Ragle Human Nutrition Research Center
state: California
Study officials:
References:
Clinical trial NCT01580956: "VARIABLE-PSV" Study
Official title: Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Respiratory Failure
Critical Illness
Ventilation Weaning
Keywords: Acute respiratory failure
Critical illness
Mechanical ventilation
Ventilation weaning
Intensive Care Unit
Variable (NOISY) PSV
PSV
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Variable PSV is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and "standard" (or fixed)-PSV during the weaning phase of critically ill patients who required mechanical ventilation.

Detailed description: Twenty patients will be enrolled. They will be ventilated withVARIABLE-PSV and STANDARD-PSV: for 24 h each in a randomized crossover order. The ventilatory parameters, ventilator/patient asynchrony, gas exchange effects, sleep quality and ventilatory comfort produced by the two ventilation modes will be compared. Before randomisation, a sequence of VARIABLE-PSV will be performed with different level of variation setting to better define the future behavior of the patient under this mode during the 24 h of Variable-PSV.

Eligibility criteria: Inclusion Criteria:

* ventilation planned for more than 48 h
* patient alert and calm corresponding to a Richmond Agitation-Sedation Scale (RASS) between -2 and 0
* Age \> or equal 18
* Surrogate decision maker's consent

Exclusion Criteria:

* Clinical instability for any reason.
* Life support withdrawal code
* Patient under tutelage
* Pregnancy
* No French health insurance

Primary outcomes:
measure: Oxygenation in each ventilatory mode
timeFrame: after 24h of mechanical ventilation in each mode
Secondary outcomes:
measure: Ventilatory comfort
timeFrame: during 24h in each mode
measure: Feasibility
timeFrame: during the 24 hours
measure: Patient/ventilator asynchronism
timeFrame: during the 24 hours
measure: Ventilatory effects
timeFrame: during the 24 hours
measure: Sleep quality
timeFrame: after the 24 hours
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital
Study officials:
References: