louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05425160: Chair Rise and Step Ups on Cardiopulmonary Parameters Among Preserved Ejection Heart Failure Patients
Official title: Effects of Chair Rise and Step Ups on Cardiopulmonary Parameters Among Preserved Ejection Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of Chair Rise and Step ups on cardiopulmonary parameters among Preserved ejection Heart Failure Patients


Eligibility criteria: Inclusion Criteria:

* Diagnosed Preserved ejection Heart Failure Patients
* Both male and female
* Age \> 60 years
* Preserved ejection fraction ≥ 45 %
* HF Duration ≥4 years

Exclusion Criteria:

* End stage heart failure
* Acute coronary syndrome
* Functional status limited due to condition other than heart failure
* Inability to adhere to study protocols.

Primary outcomes:
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: 6th week
measure: Short Physical Performance Battery (SPPB)
timeFrame: 6th week
measure: 6 Min Walk Distance (6MWT)
timeFrame: 6th Week
measure: Fatigue Assessment Scale (FAS)
timeFrame: 6th Week
measure: Heart Rate
timeFrame: 6th week
measure: Oxygen Saturation
timeFrame: 6th week
measure: VO2 Max
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Cardiology AFIC
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01738776: Nutritional Risk Factors for Hip Fracture: a Case Control Study
Official title: Nutritional Risk Factors for Hip Fracture: a Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Keywords: hip fracture
risk factors
vitamin K1
vitamin D
bone turnover markers
osteocalcin
undercarboxylated osteocalcin
bone specific alkaline phosphatase (BALP)
insulin like growth factor 1 (IGF1)
parathyroid hormone (PTH)
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2012-11-30
Enrollment: 184
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cases: The first 116 patients of an ongoing RCT were included consecutively and examined by blood samples pre operatively for nutrition and hormone analysis. The catchment area for the cases was the city of Oslo, Norway.

A control group, at the same age with no history of hip fracture, was drawn at random from inhabitants aged 60 - 100 years (median age 82 years) at the census files of Oslo in 2005.

Brief summary: Low Body Mass Index (BMI) is a risk factor for hip fracture, but it is unknown if it is the low BMI per se that increases risk of hip fracture or if specific micro-nutrients contribute. The investigators want to elucidate this aspect in a case control study studying micronutrients in serum and bone turnover markers of hip fracture patients compared with controls of the same age.


Eligibility criteria: Inclusion Criteria:

Cases are admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.

Exclusion Criteria:

* Hip fracture as part of multi-trauma or high energy trauma (defined as a fall from a higher level than 1 metre). One recent fracture in addition to the hip fracture (e.g. radius or shoulder) is acceptable.
* Regarded as moribund at admittance.
* Absence of a valid informed consent or assent.

Primary outcomes:
measure: micronutrient association with increased risk of hip fracture
timeFrame: At admission
Secondary outcomes:
measure: Are micronutrients related to bone turnover markers
timeFrame: At admission
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo, Institute of Clinical Medicine
Study officials:
affiliation: Oslo University Hospital
name: Morten Mowe, PhD
role: STUDY_CHAIR
References:
citation: Torbergsen AC, Watne LO, Frihagen F, Wyller TB, Mowe M. Effects of nutritional intervention upon bone turnover in elderly hip fracture patients. Randomized controlled trial. Clin Nutr ESPEN. 2019 Feb;29:52-58. doi: 10.1016/j.clnesp.2017.11.012. Epub 2018 Oct 30.
citation: Torbergsen AC, Watne LO, Wyller TB, Frihagen F, Stromsoe K, Bohmer T, Mowe M. Micronutrients and the risk of hip fracture: Case-control study. Clin Nutr. 2017 Apr;36(2):438-443. doi: 10.1016/j.clnu.2015.12.014. Epub 2015 Dec 23.
Clinical trial NCT02607176: Heweizhixie capsuleTherapy on Patients With Diarrhea
Official title: A Post -Marketing Drug Evaluation(Phase IV Clinical Trial) to Study the Safety and Efficacy of Heweizhixie Capsule in Patients With Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
First posted: 2015-11-17
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.

Detailed description: The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.This is a Phase 4 Open Label trial, enroll 2400 patients with diarrhea Primary Outcome Measure:Percent of subjects with treatment Success

Secondary Outcome Measures:

Number of unformed stools passed per 24 h period Time (hours) from first intake to the last unformed stools Change from baseline of Leeds dyspepsia questionnaire score Percent of subjects with AE.

Eligibility criteria: Inclusion Criteria:

3 or more unformed stools in 24 hours Male and female subjects between 18 and 80 years old Signed informed consent

Exclusion Criteria:

Subjects with serum ALT more than 5ULN or serum Cr more than 442umol/L Subjects are pregnant now, likely to become pregnant Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment.

Primary outcomes:
measure: Percent of subjects with treatment Success
timeFrame: 3 days
Secondary outcomes:
measure: Number of unformed stools passed per 24 h period
timeFrame: per 24 h period
measure: Time (hours) from first intake to the last unformed stools
timeFrame: 3 days
measure: Change from baseline of leeds dyspepsia questionnaire score
timeFrame: 3 days
measure: Percent of subjects with AE
timeFrame: 3 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Long hua hospital
Study officials:
affiliation: Shanghai University of Chinese Medicine
name: QingShan Zheng, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT01162876: A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
Official title: A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Keywords: Diabetes, Type 2
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of saxagliptin administered before breakfast for 14 consecutive days in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Patients who meet all of the following criteria will be included:

  1. HbA1c level ≥7.0% and \< 9.0%
  2. Fasting glucose level ≥130mg/dL and \<210mg/dL
  3. Patients who are capable of giving informed consent
  4. Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after completion of the study

Exclusion Criteria:

* Patients with type 1 diabetes mellitus; patients with diabetes mellitus due to other specified drugs, mechanisms, or diseases; and patients with gestational diabetes mellitus
* Patients with a medical history of diabetic coma
* Patients with heart failure
* Patients with a complication of active chronic hepatitis or hepatic cirrhosis
* Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
* Patients with a history or complication of malignant tumor

Primary outcomes:
measure: Pharmacokinetics
timeFrame: daily, up to 42days
measure: Pharmacodynamics
timeFrame: daily, up to 42 days
Secondary outcomes:
measure: Safety issues
timeFrame: daily, up to 42 days
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kyushu Clinical Pharmacology Reserch Clinic
Study officials:
References:
Clinical trial NCT03634176: Optic Nerve Sheath Diameter in Retrobulbar Ultrasound as a Surrogate Measure for Intracranial Pressure Before and After Non-invasive Strategies
Official title: Optic Nerve Sheath Diameter in Retrobulbar Ultrasound as a Surrogate Measure for Intracranial Pressure Before and After Non-invasive Strategies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hypertension
Optic Nerve Sheath Diameter
Lead sponsor: Hospital Dr. Miguel Pérez Carreño
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in the intensive care unit of the Dr. Migel Pérez Carreño hospital with increased intracranial pressure of traumatic or non-traumatic etiology.

Brief summary: Measurement of the diameter of the sheath of the optic nerve in patients hospitalized in intensive care, with increased intracranial pressure (\> 20mmHg) as a substitute measure for diagnosis and follow-up before and after different non-invasive strategies.

Three groups were created in which, through strategies already proven and non-invasive (mannitol, hypertonic solution 7.5% NaCl, reverse trendelenburg) to decrease the intracranial pressure, the optic nerve diameter measurement was performed and simultaneously the investigators monitored intracranial pressure through an intraventricular catheter continuously to determine if both correspond


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years old) with traumatic or non-traumatic elevated ICP (defined as greater than 20 mm Hg for at least 10min)
* Hospitalized in ICU
* Patients with ICP continuous measurement through an intraventricular catheter
* Respiratory rate maintained at 10-18 breaths/min to maintain the end tidal carbon dioxide partial pressure between 35 and 40 mmHg
* Peak airway pressure \<35 cmH2O
* Positive end-expiratory pressure \<5 cmH2O

Exclusion Criteria:

* Patients who had undergone cranial decompression surgery
* Patients with ocular pathology
* Patients who had previously undergone eye surgery

Primary outcomes:
measure: Optic nerve sheet diameter
timeFrame: immediately before administering the treatment according to the group and every 30 minutes after administering the treatment until 90 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Hospital Dr Miguel Perez Carreño
state: Venezuela, Bolivarian Republic Of
Study officials:
References:
Clinical trial NCT00978276: Immunohistochemical (IHC) Scoring for Receptors Expression in Breast Tissues
Official title: Concordance Study for Over Expression Level of Antibodies Within Breast Tissues
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: Receptors
Immunohistochemistry
Breast
Over expression of Hormone receptors in carcinoma of the breast sues
Lead sponsor: Applied Spectral Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The breast samples were taken from female patients after tru cut biopsies, lumpectomies or mastectomies. Paraffin embedded blocks were prepared from the specimens out of which sections were stained immunohistochemically with the Vision Bio Systems mouse monoclonal antibodies for Estrogen Receptor (NCL-ER-6F11) and Progesterone Receptor (NCL-PGR-312). All stages were performed under the routine procedure of the hospital laboratory.

Brief summary: The purpose of this study is the identification and classification of human tissues and cytology specimens and elements therein.

Computer aided technology to assist the pathologists to identify, quantify, characterize and report their findings with regards to one or more diagnoses they should perform. In particular and for example: the scoring of the number of elements and their protein (antibody) expression level within a paraffin embedded tissue section.


Eligibility criteria: Inclusion Criteria:

* Well stained paraffin embedded tissue specimens

Exclusion Criteria:

* Fade away slides

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02061176: THD Versus Open Haemorrhoidectomy
Official title: Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Keywords: Hemorrhoids
Haemorrhoids
Transanal Haemorrhoidal Dearterialization
Transanal Hemorrhoidal Dearterialisation
Open Haemorrhoidectomy
Open Hemorrhoidectomy
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively.

Secondary endpoints are postoperative pain, complications, effect on anal continence, recovery and return to normal activity, quality of life and health cost analysis.


Eligibility criteria: Inclusion Criteria:

* The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
* The patient has a Haemorrhoidal Symptom Score of 4 or more
* The patient has an American Society of Anaesthesiologists (ASA) score I-II
* The patient's age is 18-85 years at inclusion
* The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion

Exclusion Criteria:

* The patient has had previous operation for haemorrhoids within the last 2 years
* The patient has had previous operation for anal incontinence
* The patient has an active anal fistula
* The patient has an active anal fissure
* The patient has anal incontinence for solid stools

Primary outcomes:
measure: Haemorrhoidal Symptoms
timeFrame: 1-year and 5-years postoperatively
Secondary outcomes:
measure: Postoperative pain
timeFrame: 14 days postoperatively
measure: Complications
timeFrame: 1-year and 5-years postoperatively
measure: Anal continence
timeFrame: 1-year and 5-years postoperatively
measure: Quality of Life
timeFrame: 1-year and 5-years postoperatively
measure: Health cost analysis
timeFrame: 1-year and 5-years postoperatively
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Departement of Surgery, Holbaek County Hospital.
Study officials:
affiliation: Departement of Surgery, Holbaek County Hospital
name: Gunnar Olaison, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rorvik HD, Campos AH, Styr K, Ilum L, McKinstry GK, Brandstrup B, Olaison G. Minimal Open Hemorrhoidectomy Versus Transanal Hemorrhoidal Dearterialization: The Effect on Symptoms: An Open-Label Randomized Controlled Trial. Dis Colon Rectum. 2020 May;63(5):655-667. doi: 10.1097/DCR.0000000000001588.
Clinical trial NCT02081976: Periodontal Therapy in a Primary Prevention of Cardiovascular Disease
Official title: A Randomized, Controlled Trial to Study Effects of Periodontal Therapy in Primary Prevention of Cardiovascular Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Coronary Disease
Lead sponsor: Macmillan Research Group UK
Sponsor class: INDUSTRY
Collaborators: name: Saibliss Healthcare Vision
First posted: 2014-03-07
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity all over the world. In the last years, efforts have been made to define more effective therapeutic and preventive strategies.Periodontal diseases have been considered a probable risk factor for CVD with a great amount of evidence from observational studies. Although there are some interventional studies evaluating the systemic effects of periodontal therapy, there is little information regarding the impact of periodontal treatment on the prevention of cardiovascular events. To the best of our knowledge, there are no randomized controlled trials published to date assessing the effect of periodontal therapy in primary prevention of CVD.


Eligibility criteria: Inclusion Criteria:

* Individuals having at least 50% of their dentition with periodontal probing pocket depths N4 mm and
* With documented radiographic alveolar bone loss were included

Exclusion Criteria:

* Known systemic diseases
* History and/or presence of other infections
* Systemic antibiotic treatment in the preceding 3 months
* Treatment with any medication known to affect the serum level of inflammatory markers, lipids, or BP
* Pregnant or lactating females
* Allergy to tetracyclines

Primary outcomes:
measure: Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)
timeFrame: Change from baseline to six month
Secondary outcomes:
measure: High- and low-density lipoprotein cholesterol
timeFrame: Change from baseline to six month
measure: cardiovascular risk scores (Framingham)
timeFrame: Change from baseline to six months
Other outcomes:
measure: Blood Pressure and Sugar
timeFrame: Change from baseline to six months
Locations:
city: Jaipur
country: India
facility: GyanSanjeevani
state: Rajasthan
Study officials:
affiliation: Maheshwari Dental Clinic
name: Neelam Maheshwari, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Macmillan Research Group
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01842776: Care Transitions in Renal Disease Patients
Official title: Care Transitions in Renal Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Disease
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2013-04-30
Enrollment: 3300
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: Adult hemodialysis patients

Brief summary: The goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis patients. It is a quality improvement project that consistent of 4 "tracks." Tracks 1 \& 2: Implement use of checklists of activities for staff to complete when patients are admitted to the hospital, and post-hospitalization with emphasis on fluid assessment, nutrition management, patient coaching, and communication between institutions. Track 3: Work with physicians to develop process to individualize post-hospitalization dialysis orders and improve medication reconciliation. Track 4: Use a renal Care Transitions Case Manager to follow patients in the hospital and 30 days post-hospitalization to facilitate care and patient coaching.


Eligibility criteria: Inclusion Criteria:

* Chronic hemodialysis patients
* All patients admitted to the hospital during the study period

Exclusion Criteria:

* Patients \<18 years old

Primary outcomes:
measure: 30-day readmission rate
timeFrame: Participants will be followed for the duration of each hospital stay and 30 days post-hospitalization, for an expected average of 37 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Fresenius
state: Tennessee
Study officials:
References:
Clinical trial NCT04408976: Implementation Study With Decision Support Based on Data
Official title: Implementation Study With Machine Learning Based Decision Support Software for Treatment of Urinary Tract Infections in General Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Keywords: Machine learning
Clinical Decision Support Systems
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Pacmed BV
name: Zorgverzekeraar CZ
name: Zorgverzekeraar Zilveren Kruis
name: Zorgverzekeraar Menzis
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Netherlands Instititute for Health Services Research
First posted: 2020-06-01
Enrollment: 16824
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a urinary tract infection diagnosed by the general practitioner

Brief summary: This study evaluates the implementation of a machine learning based clinical decision support system for treatment of patients presenting with an urinary tract infection in general practice. The software was developed to support general practitioners in the choice of antibiotic regimen.


Eligibility criteria: Inclusion Criteria:

* Patients with a urinary tract infection in general practice
* Age \> 12 years.

Exclusion Criteria:

* No.

Primary outcomes:
measure: Non-recurrent UTI
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Netherlands Institute for Health Services Research
Study officials:
affiliation: Leiden University Medical Center
name: Willem Herter
role: STUDY_DIRECTOR
affiliation: Leiden University Medical Center
name: Tobias Bonten
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herter WE, Khuc J, Cina G, Knottnerus BJ, Numans ME, Wiewel MA, Bonten TN, de Bruin DP, van Esch T, Chavannes NH, Verheij RA. Impact of a Machine Learning-Based Decision Support System for Urinary Tract Infections: Prospective Observational Study in 36 Primary Care Practices. JMIR Med Inform. 2022 May 4;10(5):e27795. doi: 10.2196/27795.