louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01958333: Muscular and Metabolic Adaptations to Exercise to Benefit High-Risk Workforce
Official title: The Effects of Medium-Term Exercise Program on Health-Related Physical Fitness and Biochemical Outcomes in High-Risk Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Health-Related Physical Fitness
Aerobic Endurance
Muscular Endurance
Flexibility
Lead sponsor: Center for Health Sciences, Serbia
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 2114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of three different exercise programs (e.g. low-intensity, medium-intensity, high-intensity) administered for six months on health-related physical fitness, biochemical variables and general health outcomes in high-risk employees, with about 2000 volunteers will participate in the randomized and repeated-measure study.

Detailed description: Exercise programs (e.g. low-intensity, medium-intensity, high-intensity) consist of aerobic workout, strength training and flexibility exercise, with different program has different intensity, volume, frequency and duration of exercise.

Eligibility criteria: Inclusion Criteria:

* over 18 years of age

Exclusion Criteria:

* no diseases of musculoskeletal system

Primary outcomes:
measure: Cardiorespiratory endurance
timeFrame: Baseline and 6 months after intervention
Secondary outcomes:
measure: Muscular endurance
timeFrame: Baseline and 6 months after intervention
Other outcomes:
measure: Muscular strength
timeFrame: Baseline and 6 months after intervention
measure: Body composition
timeFrame: Baseline and 6 months after intervention
measure: Flexibility
timeFrame: Baseline and 6 months after intervention
measure: AHA/ACSM risk score
timeFrame: Baseline and 6 months after intervention
measure: PAR-Q score
timeFrame: Baseline and 6 months after intervention
Locations:
city: Belgrade
country: Serbia
facility: Center for Health, Exercise and Sport Sciences
Study officials:
affiliation: Center for Health, Exercise and Sport Sciences
name: Sergej M Ostojic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andres KL, Renn TA, Gray DA, Englund JM, Olsen GW, Letourneau BK. Evaluation of a cardiovascular Risk Reduction Program at a workplace medical clinic. Workplace Health Saf. 2013 Oct;61(10):459-66; quiz 467. doi: 10.1177/216507991306101006. Epub 2013 Sep 23.
citation: Smith K. Evaluation of a stretching program to increase worker flexibility. Workplace Health Saf. 2013 Aug;61(8):329-32. doi: 10.1177/216507991306100802.
citation: Birdee GS, Byrne DW, McGown PW, Rothman RL, Rolando LA, Holmes MC, Yarbrough MI. Relationship between physical inactivity and health characteristics among participants in an employee-wellness program. J Occup Environ Med. 2013 May;55(5):514-9. doi: 10.1097/JOM.0b013e31827f37d7.
Clinical trial NCT01404533: Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women
Official title: The Influence of Iron Interventions on Formation of Non-transferrin-bound Iron (NTBI) in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Keywords: NTBI
Iron
Absorption
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2011-07-28
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in the systemic circulation not bound to the iron-transport protein transferrin). The appearance of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after oral administration of iron supplements in doses similar to those used in the Pemba trial. This research project will (i) confirm the appearance of plasma non-transferrin-bound iron after administration of an iron supplement like that in the Pemba trial (\~1 mg Fe/kg body weight, without food), and then determine the effects on production of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of giving the supplemental iron (\~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a lower dose of iron (\~0.1 mg Fe/kg) - like that used in home fortification - with the standard rice meal.


Eligibility criteria: Inclusion Criteria:

* non pregnant
* non lactating
* apparently healthy women

Exclusion Criteria:

* chronic disease
* pregnancy
* lactation

Primary outcomes:
measure: Formation of NTBI following oral iron administration
timeFrame: 6 time points within 8 hours
Secondary outcomes:
measure: Serum iron isotope appearance curves
timeFrame: 6 time points within 8 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
Study officials:
affiliation: ETH Zurich
name: Richard Hurrell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brittenham GM, Andersson M, Egli I, Foman JT, Zeder C, Westerman ME, Hurrell RF. Circulating non-transferrin-bound iron after oral administration of supplemental and fortification doses of iron to healthy women: a randomized study. Am J Clin Nutr. 2014 Sep;100(3):813-20. doi: 10.3945/ajcn.113.081505. Epub 2014 Jul 23.
Clinical trial NCT01798433: STRATEGY for Left Main Coronary Bifurcation Lesion II
Official title: A Prospective, Multi-center, Randomized Study to Evaluate the Optimal Strategy for Side Branch Treatment in Patients With Left Main Coronary Bifurcation Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Angioplasty
Transluminal
Percutaneous Coronary
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.

In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.


Eligibility criteria: Inclusion Criteria:

1. Age ≥20 years
2. Left main bifurcation lesion on coronary angiography
3. Significant myocardial ischemia Main vessel (left main coronary artery and left anterior descending artery) and/or side branch (left circumflex artery) diameter stenosis \> 75%, or diameter stenosis 50-75% with angina and/or objective evidence of ischemia in the non-invasive stress test
4. Significant size of the main branch (left anterior descending artery) and side branch (left cirmflex artery) - The reference diameter of both branches ≥ 2.5 mm by visual estimation

Exclusion Criteria:

1. The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus
2. Patients who have received DES implantation in the target lesion prior to enrollment

Primary outcomes:
measure: Target lesion failure
timeFrame: 12-month
Secondary outcomes:
measure: Cardiac death
timeFrame: 12-month
measure: Angiographic in-segment restenosis rate
timeFrame: 9 months
measure: Target vessel revascularization (TVR)
timeFrame: 12-month
measure: Stent thrombosis
timeFrame: 12-month
measure: Myocardial infarction (MI)
timeFrame: 12-month
measure: Target lesion revascularization (TLR)
timeFrame: 12-month
measure: Periprocedural CK-MB elevation
timeFrame: the first 48 hours after PCI
measure: Procedure success rate
timeFrame: the first 48 hours after PCI
measure: Procedure time
timeFrame: immediate after PCI
measure: Amount of contrast dye
timeFrame: immediate after PCI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01732133: Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension
Official title: Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Keywords: Hypotension
Cesarean delivery
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing elective cesarean delivery performed under spinal anesthesia

Exclusion Criteria:

* patients with a heart rhythm disorder, Raynaud's disease or a history of vascular surgery of the upper limb

Primary outcomes:
measure: Comparison between Nexfin and intermittent measurements of blood pressure
timeFrame: two years
Secondary outcomes:
measure: Area under the curve between both measurements
timeFrame: two years
Other outcomes:
Locations:
city: Levallois
country: France
facility: Institut Hospitalier Franco-Britannique
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: Bobet M, Joachim J, Gayat E, Bonnet A, Sievert K, Barnichon C, Fischler M, Le Guen M. Blood pressure measurement during cesarean delivery: Evaluation of a beat-to-beat noninvasive device (NexfinTM). Medicine (Baltimore). 2021 Jun 4;100(22):e26129. doi: 10.1097/MD.0000000000026129.
Clinical trial NCT03234933: Post-Operative Ambulatory Challenge and Exercise (PACE) Trial
Official title: Post-Operative Ambulatory Challenge and Exercise (PACE) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is evaluating the postoperative results in terms of quality of life and functional recovery of elderly patients after cancer surgery.

Detailed description: This is a pilot study, designed to collect data on steps walked (ambulation) per day of lobectomy patients after surgery. While the investigators know ambulation improves outcomes after surgery, there is no institutional policy, set of patient goals, or method for deciding which patients require further resources, such as physical therapy. Data collected will be used to set up a hospital-wide strategy for patients to achieve post-operative ambulation milestones more readily.

Eligibility criteria: Inclusion Criteria:

* Patients Aged ≥ 18 years
* Who underwent or who will undergo lung resection at Brigham and Women's Hospital (BWH)
* With diagnosis of malignant or benign disease

Exclusion Criteria:

* Patients with baseline immobility (i.e. wheelchair-bound, use of any walking assistance device, or gait alterations)
* Patients with cognitive deficits

Primary outcomes:
measure: Number of Steps Taken
timeFrame: 2 years
Secondary outcomes:
measure: Distance walked
timeFrame: 2 years
measure: Number of Calories Burned
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Michael T Jaklitsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04433754: The Development of Pancreatic Injury in the Course of Severe Acute Respiratory Syndrome Coronavirus 2 Infection
Official title: Pancreatic Injury in Patients With COVID-19 Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who develop amylase and lipase elevation during the course of COVID 19 will be considered in the pancreatic injury group. Those who do not develop will be counted as the control group.

Brief summary: Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common.

In this study, it was aimed retrospective analysis of clinical and laboratory data of patients who developed pancreatic injury in the course of COVID 19 disease.


Eligibility criteria: Inclusion Criteria:

* Patients with amylase and lipase levels measured during covid-19 disease with or without pneumonia

Exclusion Criteria:

* Patients with pregnancy
* Patients whose amylase and lipase levels were not measured during covid 19 disease
* Patients with known solid organ malignacy
* Patients with known hematologic malignacy

Primary outcomes:
measure: to compare presence of fever in patients with and without pancreatic injury
timeFrame: 3 month
measure: to compare presence of dyspnea in patients with and without pancreatic injury
timeFrame: 3 month
measure: To compare cRP levels in patients with and without pancreatic injury
timeFrame: 3 month
measure: To compare d-dimer levels in patients with and without pancreatic injury
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University Training and Research Hospital
Study officials:
References:
Clinical trial NCT05101954: Platelet Rich Fibrin and Concentrated Growth Factors on Osseointegration of Immediate Implants
Official title: A Comparative Study Between the Effect of Platelet-rich Fibrin and Concentrated Growth Factors on Osseointegration of Immediate Implants (a Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Dental Implants
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will involve 14 patients with mandibular premolars indicated for extraction and immediate replacement. The patients will be randomly allocated into two groups and each patient will receive one implant. In Group A, a CGF membrane will be laid in the implant cavity. While in Group B, a PRF membrane will be laid in the implant cavity. Bone graft material will be applied to fill the empty parts of the socket.

Resonance frequency measurement will be done using the OSTELL device intraoperatively, at the 1st week and after 3 months. Cone-beam computed tomography will be done preoperatively, immediately following surgery, and after 3 months


Eligibility criteria: Inclusion Criteria:

* Cooperative patients with good oral hygiene.
* Patients having a history of mandibular premolars indicated for extraction and immediate replacement.

Exclusion Criteria:

* Heavy smokers.
* Parafunctional occlusal habits.
* Uncontrolled diabetes.
* History of chemotherapy or radiotherapy.
* Hematological disorders that prevent either implantation or centrifugation.
* Pregnancy.
* The nee¬d for additional augmentation or previous augmentation of the same region.
* Chronic periapical pathology

Primary outcomes:
measure: Change in implant stability
timeFrame: immediately, at 1 week, at 3 months
measure: Change in Bone density
timeFrame: immediately, after 3 months
measure: Change in bone formation
timeFrame: immediately, after 3 months
measure: Marginal bone loss
timeFrame: after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04449354: HidraWear Study for Hidradenitis Suppurativa Wounds
Official title: A Study to Evaluate the HS Specific Wound Dressing HidraWear AX in the Home Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Hidradenitis
Lead sponsor: HidraMed Solutions Ltd
Sponsor class: INDUSTRY
First posted: 2020-06-26
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The product, HidraWear AX (www.hidrawear.com) is and adhesive free wound dressing system for the every day home care of Hidradenitis Suppurativa (HS), a debilitating disease of the skin for which there are limited wound dressing products.

This is a study to assess the use HidraWear Ax vs current product and method of use, and to determine the impact on patients' quality of life.

Detailed description: The objective is to evaluate the ease of use of Hidrawear AX compared to the subject's existing product use in 23 subjects with HS (Hidradenitis Suppurativa).

Secondary objectives are to evaluate if Hidrawear AX:

* Is comfortable
* Improves quality of life
* Faster to use than the subject's existing product
* Reduces dressing related pain
* Secure dressing retention

This pilot study will evaluate usability - the safety, efficacy and performance of HidraWear AX in the home setting. Quality of life, ease of use and comfort of Hidrawear AX will be assessed.

The clinical effect of the wound pad will not be assessed.

Eligibility criteria: Inclusion Criteria:

* In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Provision of signed and dated informed consent form in English.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Female, aged \>18
  4. Diagnosed with Hidradenitis Suppurativa
  5. Hidradenitis Suppurativa affecting the axilla
  6. Exuding lesion that requires wound dressings

Exclusion Criteria:

* 1. Recent surgery \<3 months in axilla 2. Psoriasis, Dermatitis or skin conditions/rash other than Hidradenitis Suppurativa on or near affected area 3. Pregnancy or lactation 4. Known allergic reactions to components of Hidrawear AX

Primary outcomes:
measure: Ease of Use Day 21 vs Day 0
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI)
timeFrame: 3 weeks
measure: Visual Pain Analogue Scale Day 21 vs Day 0
timeFrame: 3 weeks
measure: Time Taken to Dress Wounds
timeFrame: 3 weeks
measure: Body Image Visual Analogue Scale
timeFrame: 3 weeks
measure: Patient Comfort
timeFrame: 3 weeks
measure: Confidence in Dressing Product (Secure Retention, Leak Reduction)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: The Hermitage Clinic
Study officials:
affiliation: Hermitage Clinic
name: Trevor Duffy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04461054: Which Type of Laparoscopic Colectomy, Right or Left, Have Better Postoperative Outcomes for the Patients?
Official title: Which Type of Laparoscopic Colectomy, Right or Left, Have Better Postoperative Outcomes for the Patients?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Disorders
Keywords: colectomy
colorectal
laparoscopy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Rodrigo Ambar Pinto
First posted: 2020-07-08
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colon adenocarcinoma

Brief summary: Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy.

Objective: To compare perioperative morbidity of the right versus left colectomy for cancer, as well as the quality of laparoscopic oncologic resection of both procedures. Methods: Retrospective analysis of prospectively collected data from patients operated at the University of São Paulo School of Medicine, between 2006 and 2016. Postoperative complications were classified with scale within 30 days after surgery. Grade III or greater was considered serious complication. Quality of oncologic resection was assessed by the average number of lymph nodes harvested and surgical margins.

Detailed description: Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy.

This retrospective analysis of prospectively collected data from patients operated at the University of São Paulo School of Medicine, between 2006 and 2016. Postoperative complications were classified by scale within 30 days after surgery. There were 332 patients operated.

Eligibility criteria: Inclusion Criteria: patients who underwent laparoscopic right or left elective colectomy for colon adenocarcinoma.

Exclusion Criteria: Patients who underwent total colectomy

* Resections that included the rectum
* Exclusive transverse resections
* Multivisceral resections

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Medicine School, Sao Paulo University
Study officials:
affiliation: University of Sao Paulo
name: Rodrigo A Pinto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: