louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01407289: A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia
Official title: An Open, Single-centre, Controlled Trial to Investigate the Efficacy and Usability of Published Best Practice to Control Glycaemia in Hospitalised Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the efficacy of enhanced published best practice paper-based insulin titration protocol for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Blood glucose in the range between 140 - 400 mg/dl
* Expected stay ≥ 48 hours

Exclusion Criteria:

* Hyperglycemia without known history of type 2 diabetes mellitus
* Impaired renal function (serum creatinine ≥3.0mg/dL)
* Clinically relevant hepatic disease

Primary outcomes:
measure: Mean blood glucose
timeFrame: duration of hospital stay (48 hours - maximum three weeks)
Secondary outcomes:
measure: Number of glucose measurements in hyperglycaemic ranges
timeFrame: duration of hospital stay (48 hours - maximum three weeks)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Division of Internal Medicine, Department of Endocrinology and Metabolism/ Cardiology
Study officials:
affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine Medical University of Graz
name: Thomas Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Donsa K, Beck P, Holl B, Mader JK, Schaupp L, Plank J, Neubauer KM, Baumgartner C, Pieber TR. Impact of errors in paper-based and computerized diabetes management with decision support for hospitalized patients with type 2 diabetes. A post-hoc analysis of a before and after study. Int J Med Inform. 2016 Jun;90:58-67. doi: 10.1016/j.ijmedinf.2016.03.007. Epub 2016 Mar 23.
citation: Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.
Clinical trial NCT04052789: Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns
Official title: Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Badly Decayed Teeth andTeeth Restored With Large Filling Restorations and Endodontically Treated Teeth and Malformed Teeth and Malposed Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 16
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: All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. The success of dental restorations is determined by four main factors: biocompatibility, aesthetic value, resistance to fracture and marginal adaptation. . An inadequate marginal fit may compromise the longevity of the restoration since cement film exposure to the oral environment can lead to its dissolution . .

Polyetheretherketone (PEEK) is a polymer that has many potentials uses in dentistry. Polyetheretherketone (PEEK) can be used to support fixed dental prostheses. However, information about physio mechanical characterization is still scarce.

Aim of the study:

- The aim of this study is to evaluate the internal fit of milled BioHPP PEEK-based versus zirconia-based single crowns.


Eligibility criteria: Inclusion Criteria:

* From 18-50 years old, be able to read and sign the informed consent document.
* Patient Have no active periodontal or pulpal diseases, have teeth with good restorations
* Patient Psychologically and physically able to withstand conventional dental procedures
* Patients with teeth problems indicated for single posterior crowns:

Exclusion Criteria:

* Patient less than 18 or more than 50 years
* Patient with active resistant periodontal diseases
* Patients with poor oral hygiene and uncooperative patients
* Patients in the growth stage with partially erupted teeth
* Patient with Psychiatric problems or unrealistic expectations
* Patient with Lack of opposing dentition in the area of interest

Primary outcomes:
measure: Internal fit of the crown by measuring the thickness of the replica by steriomicroscope
timeFrame: one year
Secondary outcomes:
measure: secondary caries if present at the margin of the crown by using probe
timeFrame: one year
Other outcomes:
measure: patient satisfaction
timeFrame: one year
Locations:
Study officials:
References:
Clinical trial NCT06591689: Relationship Between Communication and Gross Motor Function in Quadriparetic Cerebral Palsy
Official title: Investigation of the Relationship Between Communication Function and Gross Motor Function in Patients With Quadriparetic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy, Spastic Quadriplegic
Communication Disorder, Childhood
Gross Motor Delay
Lead sponsor: Acıbadem Atunizade Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty quadriparetic cerebral palsy individuals between the ages of 0-17 were included in the study.

Brief summary: Communication problems are frequently encountered in quadriparetic cerebral palsy. Additionally, motor impairments often accompany this condition. Communication problems can also reduce the benefits gained from treatments, which in turn negatively affects individuals functional independence as motor impairments persist. In this study, the researchers aimed to examine the relationship between communication function, gross motor function and functional independence level.

Detailed description: This study is an observational study conducted with data obtained from assessment scales and does not involve any treatment. The target population of the study consists of individuals diagnosed with quadriparetic cerebral palsy (QCP). Individuals with QCP aged 0-17 years were included in the study. Detailed medical histories were taken from the participants, and they were evaluated using the Communication Function Classification System (CFCS), the Pediatric Functional Independence Measure (WeeFIM), and the Gross Motor Function Measure-88 (GMFM-88). The aim of this study is to examine the effect of communication function on gross motor function and independence.

Eligibility criteria: Inclusion Criteria:

* Ages between 0-17,
* Diagnosed with quadriparetic cerebral palsy,
* Participants and parents willing to participate in the study voluntarily.

Exclusion Criteria:

* Having different types of cerebral palsy such as dyskinetic, ataxic and mixed type,
* Having spastic diparetic or hemiparetic type cerebral palsy,
* Having any history of surgery on the musculoskeletal system,
* Having received Botulinum Toxin injections in the last 6 months

Primary outcomes:
measure: Communication Function Classification System (CFCS)
timeFrame: 1 month
measure: The Pediatric Functional Independence Measure (WeeFIM)
timeFrame: 1 month
measure: The Gross Motor Function Measure-88 (GMFM-88)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Altunizade Hospital
Study officials:
References:
Clinical trial NCT00866489: The Neuroprotective Effects of RPC on the Neurosurgery
Official title: Clinical Trial Cencer, Xijing Hospital, Fourth Military Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: s100b
Keywords: Experimental
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2009-03-20
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current study is designed to clarify the neuroprotective effect of remote ischemic precondtioning on the patients underwent neurosurgery.

Detailed description: BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and mortality after neurosurgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective neurosurgery, a randomized trial will be performed in current study.

DESIGNING Thirty patients undergoing craniotomy for supratentorial meningioma will be randomize assigned to neurosurgery with RIPC or conventional neurosurgery (control). Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was assessed by S-100b, NSE, and neurological function scores in different time points.

EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury.

CONCLUSIONS:

In patients undergoing elective craniotomy for supratentorial meningioma, RIPC reduces the incidence of postoperative cerebral injury.

Eligibility criteria: Inclusion Criteria:

* Patients referred for primary elective neurosurgery were invited to participate in the study at the time of scheduling for operation

Exclusion Criteria:

* Potential participants were excluded if they were \>70 years of age
* Required concomitant procedures other than neurosurgery
* Had experienced an acute coronary syndrome or myocardial infraction within 3 months
* Were unable to give informed consent
* Were taking sulfonylurea oral hypoglycemic agents or nicorandil drug therapy because these agents have been shown to effect preconditioning.

Primary outcomes:
measure: S-100b and NSE level
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Hailong DONG, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00141089: Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
Official title: Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Constipation
Keywords: Male patients, chronic constipation, tegaserod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 1026
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists.

The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.


Eligibility criteria: Inclusion Criteria:

* A 6-month history of constipation defined as \<3 complete spontaneous bowel movements per week and \>1 of the following symptoms \>25% of the time: hard stools, sensation of incomplete evacuation and straining

Exclusion Criteria:

* Patients with cancer, inflammatory bowel disease or other structural bowel disease
* Past or current diagnosis of irritable bowel syndrome were excluded.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.
Secondary outcomes:
measure: For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm.
measure: Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use.
measure: Safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Basel
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT05095389: Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers
Official title: Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Diabetic Foot Ulcers: a Prospective, Double-blind, Multi-center, Randomized, Parallel-group Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer
DFU
Non-healing Foot Ulcer
Lead sponsor: Paracrine, INC.
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 290
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel-Group, Double-Blind, Placebo Controlled
Primary purpose: TREATMENT

Brief summary: A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).

Detailed description: Subjects will have at least one diabetic foot ulcer between 1 cm2 and 16 cm2 area that remains open despite at least 30 days of DFU care and will need debridement as a part of their care.

Subjects will be randomly assigned to one of two groups (ADRC Group will receive standard care plus ADRC, and Control Group will receive standard care plus matched placebo).

ADRCs will be harvested from a small volume liposuction performed on the same day as, but prior to, the debridement procedure. Fat harvest will occur through small volume (approximately 100-200 mL) liposuction prior to the surgical debridement procedure on the same day as the planned autograft procedure.

The lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for application to an autograft site. Cells will be delivered via direct injection (minimal wound penetration with a 22 gauge needle, total volume 5 mL) into the DFU (injected around the circumference and applied to the base of the ulcer).

Eligibility criteria: Inclusion Criteria:

* T1D or T2D
* Diabetic Foot Ulcer, from 1 to 12 months in duration
* Wagner Grade 1 or Superficial 2
* Adequate perfusion
* Able to undergo liposuction

Exclusion Criteria:

* Diabetic Foot Ulcer penetrates to capsule, tendon, or bone
* Active infection
* Non-diabetic neuropathy
* Significant cardiovascular event within 6 months before screening

Primary outcomes:
measure: DFU Closure Rate
timeFrame: 12 Weeks
Secondary outcomes:
measure: Percent Reduction of Wound Area
timeFrame: 12 Weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02254889: Pain After Endoscopic Submucosal Dissection
Official title: Pain After Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Neoplasm
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric neoplasms. Although ESD-related complications such as bleeding and perforation have been reported, data is currently lacking on the development of pain, which is one of the most common adverse events after ESD. Therefore, in the present study, we investigated the incidence and clinicopathologic risk factors of pain after ESD.

Detailed description: A prospective randomized controlled study was conducted evaluating 156 patients with gastric neoplasms treated by ESD at Gangnam Severance Hospital between April 2011 and December 2014. All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) either before or after ESD.

Eligibility criteria: Inclusion Criteria:

* patients undergoing ESD for gastric neoplasms

Exclusion Criteria:

* (1) history of acid suppressive medication within 1 week prior to the procedure; (2) known gastrointestinal disorders, such as peptic ulcer disease, which might impact epigastric pain assessment; (3) current or regular use of pain medication; (4) history of upper gastrointestinal surgery; (5) multiple lesions requiring ESD; (6) perforation during ESD; and (7) significant cardiovascular, renal, hepatic, neurotic, or psychological disorders

Primary outcomes:
measure: A 10-cm VAS was used to evaluate pain after ESD.
timeFrame: Pain was rated at 24 hours after ESD.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Da Hyun Jung
Study officials:
affiliation: Gangnam Severance Hospital
name: Young Hoon Youn, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Jung DH, Youn YH, Kim JH, Park H. Factors influencing development of pain after gastric endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2015 Dec;47(12):1119-23. doi: 10.1055/s-0034-1392537. Epub 2015 Jul 10.
Clinical trial NCT06204289: Effects of Nurse-led Supportive Care Programme on Caregiver Burden and Resilience of Family Caregivers
Official title: Effects of Nurse-led Supportive Care Programme on Caregiver Burden and Resilience of Family Caregivers of Patients With Lung Cancer: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse-led Supportive Care
Keywords: Lung cancer
Family caregivers
Caregiver burden
Resilience
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lung cancer is the leading cause of cancer-related deaths worldwide, with a mortality rate of 18%. The prognosis of lung cancer is progressive and devastating, which may cause patients to experience problems during the treatment and care process. Due to the problems experienced by lung cancer patients, their need for support increases and the care process is provided mostly in the home environment, causing family members to take on important roles as caregivers. Therefore, the resilience of family caregivers decreases and they feel burden.


Eligibility criteria: Inclusion Criteria:

* A family member who has been a primary caregiver for at least one year
* Literate
* Willingness to participate in the study

Exclusion Criteria:

* Have any communication disability
* Have any diagnosed physical or psychological disorder
* Receiving any supportive care

Primary outcomes:
measure: Zarit Burden Interview (ZBI)
timeFrame: The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.
Secondary outcomes:
measure: Connor-Davidson Resilience Scale Short Form (CDRSSF)
timeFrame: The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bakircay University Faculty of Health Sciences
Study officials:
affiliation: Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560
name: Pinar Zorba Bahceli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05506189: Life Style Modification for Breast Canccer Survivors Using Mobile App-based Human Coaching Program
Official title: A Prospective Study on the Effect of Quality of Life and Life Style Modification for Breast Cancer Survivors Using Mobile App-based Human Coaching Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Survivors
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2022-08-18
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: breast cancer survivors with 25 and more than 25 of BMI

Brief summary: This study is aimed to investigate whether mobile app-based human coaching program for 6 months is effective for reducing BMI in breast cancer survivors with overweight and obesity.


Eligibility criteria: Inclusion Criteria:

1. breast cancer survivors who have completed acute treatment of breast cancer
2. Age: 18 \~ 70 year old
3. stage: I, II, III
4. BMI≥25.0 Kg/m2
5. breast cancer survovrs who can use mobile application program
6. breast cancer survovrs who agree with this study's consent

Exclusion Criteria:

1. Stage IV, carcinoma in situ
2. breast cancer survivors who don't use smartphone
3. breast cancer survivors with previous other malignant disease
4. breast cancer survivors with multiple malignancies
5. breast cancer survivors with uncontrolled chronic comorbid disease
6. breast cancer survovrs who disagree with this study's consent

Primary outcomes:
measure: reduction of body mass index (BMI)
timeFrame: Baseline and 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: Center for Breast Cancer, National Cancer Center, Korea
name: So-Youn Jung, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: