louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04979312: Glucose and Blood Pressure During Pregnancy
Official title: Predictive Role of Non-Invasive Glucose Assessment During Pregnancy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Pre-Eclampsia
Blood Pressure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this research is to examine the beneficial effects of regular, non-invasive, glucose (sugar) assessment on glucose (sugar) and blood pressure regulation during pregnancy to help in predicting gestational diabetes and preeclampsia.

Detailed description: This is an open-label pilot trial for the LabClasp combined with standard clinical care compared to standard clinical on \[glucose\] and blood pressure during pregnancy. Potential study participants will be pre-screened using questionnaires and review of their clinical records. Once the consent has been obtained, participants will undergo screening to confirm eligibility. Subjects who meet all criteria will be randomized to either LC+SC or SC cohorts for 24-39wks depending upon their gestational duration at enrollment. Study measures including anthropometrics, surveys/questionnaires, 24hr ABPM, accelerometry, and an oral glucose tolerance test (OGTT). Furthermore, the investigators will obtain repeated (annual) subject information including vitals, labs, medications, and development of cardiometabolic disorders for up to 10yrs in follow-up by reviewing Mayo Clinic medical records.

Eligibility criteria: Inclusion Criteria:

* Age range: 18-45 years (inclusive)
* Body mass index (BMI) ≤40kg/m2
* \>1 risk factor for GDM
* \<16wks gestation
* Gender: only females will be recruited into this study
* Ability to provide written informed consent

Exclusion Criteria:

* Presence of chronic kidney disease (creatinine \>2.5mg/dL) and/or active cancer
* Smoking
* Multiple pregnancies
* Congenital abnormalities
* Use of chronic medications which influence blood \[glucose\] or \[insulin\]
* Subsequent diagnosis of GDM or preeclampsia

Primary outcomes:
measure: Blood Glucose
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Diastolic Blood Pressure
timeFrame: Baseline
Secondary outcomes:
measure: Pittsburgh sleep study quality index
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01755312: The Effect of Medication Reminder Technology on Medication Adherence and Hypertension Outcomes
Official title: The Effect of Medication Reminder Technology on Medication Adherence and Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Medication Adherence
Blood Pressure
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study to evaluates how a med reminder affects the patient's ability to take medications as prescribed


Eligibility criteria: Inclusion Criteria:

* poor medication adherence
* high blood pressure

Exclusion Criteria:

-

Primary outcomes:
measure: self-reported medication adherence using the Morisky 8-Item Medication Adherence Scale(MMAS-8) tool
timeFrame: 6 months
Secondary outcomes:
measure: systolic blood pressure in mmHg using a valid automated device
timeFrame: 6 months
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
Clinical trial NCT04364412: Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy
Official title: Acute Lower gastroIntestinal BleedIng (ALIBI Study): a Multicentre Prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower GI Bleeding
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 1198
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: Consecutive, unselected outpatients acutely admitted for LGIB or developing LGIB during hospital stay (inpatients) were eligible for inclusion if they fulfilled the following criteria: i) age \> 18 years; ii) recent (\< 3 days) onset of overt bleeding with bright or dark blood or clots per rectum or melaena without hematemesis

Brief summary: Unlike upper GI bleeding, for LGIB there is still a paucity of data on clinical presentation, patient characteristics, pathways of care and outcomes for LGIB patients. In-hospital mortality ranges from 1.2% to 8.8% (2-4), according to retrospective studies, but data from prospective series are still limited (5).

Present multicentre, prospective, observational study was designed to explore these areas, to assess variations in practice management and to identify factors associated with patient outcomes.


Eligibility criteria: Inclusion Criteria:

* adult patients with acute lower GI bleeding

Exclusion Criteria:

* age below 18 years
* bleeding patients with an upper GI source

Primary outcomes:
measure: Mortality rate in patients admitted for acute lower GI bleeding
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Como
country: Italy
facility: Valduce Hospital
Study officials:
References:
citation: Radaelli F, Frazzoni L, Repici A, Rondonotti E, Mussetto A, Feletti V, Spada C, Manes G, Segato S, Grassi E, Musso A, Di Giulio E, Coluccio C, Manno M, De Nucci G, Festa V, Di Leo A, Marini M, Ferraris L, Feliziani M, Amato A, Soriani P, Del Bono C, Paggi S, Hassan C, Fuccio L. Clinical management and patient outcomes of acute lower gastrointestinal bleeding. A multicenter, prospective, cohort study. Dig Liver Dis. 2021 Sep;53(9):1141-1147. doi: 10.1016/j.dld.2021.01.002. Epub 2021 Jan 25.
Clinical trial NCT03368612: Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function
Official title: Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiration Disorders
Lead sponsor: Ospedale Santa Croce-Carle Cuneo
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The study aims at evaluating the AirGoTM system's performance, as compared to standard pulmonary function tests.

Detailed description: Primary endpoint:

• To test the AirGoTM system's respiratory rate recording accuracy at rest and during physical exercise, as compared to standard tests.

Secondary endpoints:

* To test the accuracy of the AirGoTM system's derived respiratory parameters (tidal volume, minute ventilation, Tiffeneau-Pinelli index, FEV1 and VO2max) at rest and during physical exercise, as compared to standard tests.
* To test comfort and subjects' compliance with the AirGoTM system during long term recording (24 hours).

Eligibility criteria: Inclusion Criteria:

* Non-smoker healthy volunteers,
* Able to perform a routine respiratory function test (spirometry and cardiopulmonary exercise testing),
* aged between 18 and 75 years,
* who signed a written informed consent.

Exclusion Criteria:

* Present cardiac comorbidities (eg. coronary artery disease, heart failure, arrhythmias);
* History of coronary artery disease or heart failure;
* Respiratory comorbidities (eg. asthma, chronic obstructive disease, sleep apnoea, lung interstitial disease);
* Pregnancy;
* Former smoker of \>5 p/y;
* Severe trauma or major surgery in the last year;
* Chest pain;
* Obesity (BMI \>30).

Primary outcomes:
measure: respiratory rate
timeFrame: 4 minutes
Secondary outcomes:
measure: tidal volume
timeFrame: 4 minutes
Other outcomes:
Locations:
city: Cuneo
country: Italy
facility: A.O. S. Croce E Carle Di Cuneo
Study officials:
References:
Clinical trial NCT01114412: Basic Sensations Coming From the Bladder
Official title: Description of Basic Visceral Sensations Coming From the Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Overactive Bladder Syndrome
Keywords: focus groups
overactive bladder
bladder sensations
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Patients with overactive bladder

Brief summary: A major complication in studies to identify the nature of bladder sensations is language. It is difficult, if not near impossible, for the lay person, with no knowledge of physiology, anatomy or pathology, to put into simple terms a description of basic visceral sensations. Therefore, before the investigators can speculate about the detailed mechanisms generating sensation the investigators must overcome this language and communication difficulty. This will be addressed in the present study.

There are important reasons why the investigators must identify the mechanisms generating the different sensations as the bladder fills. One of them is that these are basic physiological mechanisms which need to be better understood.


Eligibility criteria: Inclusion Criteria:

Healthy volunteers

* Healthy students from The University of Maastricht well versed in Dutch.

Patients

* Patients with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days. Before the start of any anticholinergic or other therapy. Patients on anticholinergic therapy will be asked to stop this therapy for at least 10 days before they enter the first session.
* Well versed in Dutch.

Exclusion Criteria:

Healthy volunteers

* Use of any medication (except oral contraceptives)
* Surgical history of the abdomen
* Urinary complaints (e.g. frequency, urgency)
* Urinary tract infection

Patients:

* Congestive heart disease or history of heart failure
* Presence of urinary tract infection. These patients will be treated by antibiotics.

Primary outcomes:
measure: description of bladder sensations
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: Gommert A van Koeveringe, MD, PhD, Urologist
role: STUDY_DIRECTOR
References:
Clinical trial NCT04162912: Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours
Official title: Effects of a Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours Among Patients With Palliative Care Needs: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Disease
Keywords: Advance Care Planning
Motivational Interviewing
Pallative Care
Lead sponsor: Food and Health Bureau, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Haven of Hope Hospital
name: United Christian Hospital
First posted: 2019-11-14
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This proposed study is designed to test the effects of motivational interviewing (MI) in increasing the uptake of ACP behaviours among patients with palliative care needs. A randomised controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of a MI-tailored ACP (MI-ACP) programme on palliative care patients recruited from the outpatient palliative care clinics and home palliative care services of two hospitals. A total of 204 patients will be recruited and randomly assigned to experimental and control groups. The patients in the experimental group will receive a MI-ACP programme facilitated by a trained nurse, whereas the patients in the control group will receive usual care. Primary outcome is the behavioural changes in ACP. Secondary outcomes are perceived stress, decisional conflict and quality of life. Study outcomes will be measured at baseline, 1 month and 3 months after enrolment.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or over
* newly referred to palliative care services
* with a palliative performance scale (PPS) score of 60 or above; and
* with full level of consciousness

Exclusion Criteria:

* uncommunicable because of sensory impairment or language barrier
* cognitively impaired
* are receiving active psychiatric treatment
* already had signed an advance directive

Primary outcomes:
measure: Advance Care Planning Behaviour
timeFrame: Baseline, 1 month and 3 months follow up
Secondary outcomes:
measure: Decisional conflict
timeFrame: Baseline, 1 month and 3 months follow up
measure: Perceived stress
timeFrame: Baseline, 1 month and 3 months follow up
measure: Quality of life
timeFrame: Baseline, 1 month and 3 months follow up
Other outcomes:
Locations:
city: Kwun Tong
country: Hong Kong
facility: United Christian Hospital
city: Tseung Kwan O
country: Hong Kong
facility: Haven of Hope Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Helen N Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01291212: Efficacy of Luteinizing Hormone (LH) Activity in Low Responder Patients With Transdermal Testosterone
Official title: Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Other Complications Associated With Artificial Fertilization
Keywords: In Vitro Fertilization
Testosterone
Ovarian Stimulation
Luteinizing Hormone
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.

Detailed description: Studies in macaques have indicated that androgens have some synergistic effects with follicular stimulating hormone (FSH) on folliculogenesis. Our previous clinical studies demonstrated the usefulness of pretreatment with transdermal testosterone in low-responder IVF patients.

There is controversy on the usefulness of recombinant luteinizing hormone (LHr) added to FSHr in ovarian stimulation of low responder patients. Thus, our present study has been designed to compare ovarian stimulation with FSHr alone versus LHr added to FSHr when transdermal testosterone pretreatment is used.

Eligibility criteria: Inclusion Criteria:

* Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes

Exclusion Criteria:

* FSH \> 12
* Previous ovarian surgery

Primary outcomes:
measure: ovarian response
timeFrame: within 2 weeks after begining ovarian stimulation
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: within 5 weeks (plus or minus 1 week) after embryo transfer
measure: Implantation rate
timeFrame: within 5 weeks (plus/minus 1 week) after embryo transfer
measure: Live birth rate
timeFrame: within 9 months (plus/minus 1 month) after embryo transfer
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
Study officials:
References:
citation: Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.
citation: Fabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.
Clinical trial NCT02016612: Seri Surgical Scaffold Support of the Lower Pole of the Breast
Official title: Seri Surgical Scaffold (TM) Support of the Lower Pole of the Breasts in Augmentation Mastopexy or Breast Reduction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Ptosis of the Breast
Keywords: Recurrent
Ptosis
Reduction
Mammoplasty
Mastopexy
Lead sponsor: Bengtson Center
Sponsor class: OTHER
Collaborators: name: Allergan Medical
First posted: 2013-12-20
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D Imaging system reporting the amount of breast tissue above and below the nipple level.

Detailed description: Patients having augmentation mastopexy or breast reduction will be informed about Seri Scaffold and allowed to have Seri support included in their surgery or not. If the choose the scaffold will be placed under the skin in the lower pole of the breast as an internal hammock to help take weight off of the breast and potentially help prevent future stretch of the lower pole.

Eligibility criteria: Inclusion Criteria:

Age =\>18 years

* requesting procedure
* No active cancer or infection

Exclusion Criteria:

* Known allergy to silk
* Pregnant or lactating

Primary outcomes:
measure: Nipple to Fold Measurement on Stretch
timeFrame: 1 year post op
Secondary outcomes:
measure: Percent Breast Tissue Above Nipple
timeFrame: 1 year post op
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Bengtson Center for Aesthetics and Plastic Surgery
state: Michigan
city: Grand Rapids
country: United States
facility: Center for Aesthetics and Plastic Surgery
state: Michigan
Study officials:
affiliation: Bengtson Center
name: Bradley P Bengtson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00920712: Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastritis
Keywords: chronic atrophic gastritis
Traditional Chinese Medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Weiqi decoction on Chronic Atrophic Gastritis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Chronic Atrophic Gastritis
* Male of female patients between 18-65 years old
* Written informed consent

Exclusion Criteria:

* Combine with malignant pathology on epithelial dysplasia of gastric mucosa
* Combine with duodenal ulcer or gastric ulcer
* Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
* Pregnancy or breast feeding women, or unwilling to have contraception.

Primary outcomes:
measure: Symptoms and conditions of tongue and pulse,the gastroscopy and pathological change
timeFrame: 12 weeks
Secondary outcomes:
measure: Indicates of liver and renal function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua hospital
state: Shanghai
Study officials:
affiliation: Shanghai University of Chinese Medicine
name: Xie Jianqun, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01761812: Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods
Official title: Determining the Extent and Grade of Prostate Cancer Using MR Elastography, Diffusion Weighted Imaging, and Dynamic Contrast Enhanced MRI With Gadofosveset
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
MRI
Elastography
Gadofosveset
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.


Eligibility criteria: Inclusion Criteria:

* male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy

Exclusion Criteria:

* unable to give informed consent
* contraindication to MRI or MRI contrast agent
* claustrophobia
* renal impairment
* prior hormonal or radiation therapy for prostate cancer
* active prostatitis
* moderate to severe rectal inflammation
* previous rectal surgery
* prostate biopsy within 4 weeks of planned MRI

Primary outcomes:
measure: Correlation coefficient
timeFrame: This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).
measure: Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method
timeFrame: This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre, University of Toronto
name: Masoom A Haider, M.D.
role: PRINCIPAL_INVESTIGATOR
References: