louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05856292: Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
Official title: Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Pain
Keywords: Cancer Pain
Education
Lead sponsor: Tarumanagara University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Placebo Group 2: Teach-Back
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized prospective quantitative pilot study compared teach-back method to standardized educational method in patient and caregiver to improve cancer pain management

Detailed description: Even though there are comprehensive guidelines for cancer pain management, pain control among cancer patients and survivors is often suboptimal due to undertreatment. According to recent studies, the addition of educational interventions could improve pain relief in cancer patients. Both patients and family caregivers play an important role in delivering cancer pain self-management, especially at home. Providing knowledge for cancer pain management with optimal intervention could improve patient and caregiver outcomes.

The Teach-back method, where patients and family caregivers are asked to repeat the instruction they've received from their health care professionals, can assess patients' understanding, repeat or modify the educational material if comprehension is not demonstrated. This pilot study compared the addition of the Teach-back method for cancer patients and their caregivers and its relation to cancer pain management.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe pain (pain scale 4 and above)
* ≥18 years old
* Signed the informed consent
* Willing to cooperate until the end of studies
* The patient is fully conscious and able to communicate well
* Cared by a family caregiver
* Family caregiver able to fully function as a caregiver

Exclusion Criteria:

* Near-death (dying) stage
* Not willing to cooperate until the end of studies
* Altered mental status and communication difficulties

Primary outcomes:
measure: Cancer pain management
timeFrame: one month
Secondary outcomes:
measure: Health Literacy
timeFrame: one month
measure: Pain Level
timeFrame: weekly up to one month
measure: Distress
timeFrame: weekly up to one month
measure: Belief
timeFrame: one month
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dharmais National Cancer Centre
Study officials:
References:
Clinical trial NCT05970692: Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Official title: Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Pain
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Bitlis Eren University
First posted: 2023-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CTS patients aged between 18-65 years old

Brief summary: This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L scale) and to perform validity and reliability evaluations.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-65 years old,
* Had symptoms of numbness, tingling, weakness and pain in the hands for at least 1 month,
* Assessed through provocation tests and physical examination to match the median nerve distribution.

Exclusion Criteria:

* Not willing to participate in the study,
* Clinical or electrophysiological signs of proximal nerve compression,
* Diabetes or other metabolic disease,
* Rheumatoid arthritis or other general inflammatory diseases.

Primary outcomes:
measure: Atroshi-Lyrén 6-item symptoms scale
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
References:
Clinical trial NCT06066892: Accuracy Evaluation of Different "All on Four" Impression Techniques Using Plaster Jig
Official title: Accuracy Evaluation of Different "All on Four" Impression Techniques Using Plaster Jig
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Implant Prosthodontics
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be conducted to evaluate the accuracy of different implant impression techniques using plaster jig Participants will have three types of impression techniques


Eligibility criteria: Inclusion Criteria:

Non smokers Good oral hygiene Free from any signs of implant failure and requesting a fixed prosthesis

Exclusion Criteria:

* patients that have severe bone resorption or excessive interarch space

Primary outcomes:
measure: Accuracy of impression technique
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: El Mansura
country: Egypt
facility: Doaa Mowafy
state: Dakahlia
Study officials:
References:
Clinical trial NCT04181892: Effect of Connective Tissue Graft Position
Official title: The Effects of Connective Tissue Graft Position on Clinical and Aesthetical Outcomes of Gingival Recession Treatment. A Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: connective tissue graft
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: The aim of this study was to compare the root coverage and aesthetic results of CAF+ CTG positioned apical to the CEJ (CAF+CTG-ACEJ) with CAF+CTG positioned on the CEJ (CAF+CTG-CEJ) for treating isolated gingival recession defects.

Methods: Thirthy-eight patients with Miller class I and II gingival recessions were enrolled. 19 patients were randomly assigned to the CAF+CTG-ACEJ group or CAF+CTG-CEJ group. Clinical and aesthetical evaluations were made at 6 months.


Eligibility criteria: Inclusion Criteria:

* 19 years of age,

  * Periodontally and systemically healthy,
  * FMPS and FMBS \<15%,
  * Presence of Miller Class I/II GR defect (≥3 mm in depth) at the buccal aspect of incisors and canines,
  * Presence of identifiable CEJ (step ≤1 mm at CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ, was accepted),
  * No previous periodontal surgery.

Exclusion Criteria:

* Smoking,
* Contraindications for surgery,
* Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.

Primary outcomes:
measure: Gingival Recession depth in millimeters
timeFrame: 6 months
measure: keratinized tissue height in millimeters
timeFrame: 6 months
measure: aesthetic evaluation assesed by visual analog scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Dentistry
Study officials:
affiliation: Professor
name: Onur Ucak Turer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01718392: Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: combined training
insulin resistance
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 development of insulin resistance in multiple sclerosis patients + explaining the effects of a combined training programme on insulin resistance, muscle power and aerobic capacity in multiple sclerosis patients


Eligibility criteria: Inclusion Criteria:

* Diagnosed MS according to the McDonald criteria
* Expanded Disability Status Scale (EDSS) between 0.5 and 6
* Be able to train 5 times in 2 weeks at the University

Exclusion Criteria:

* Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases (like diabetes type 2)
* Having had an relapse in a period of 3 months prior to the start of the intervention period
* Having an relapse during the intervention period
* Pregnancy and other contra indications for physical activity
* Mental disorders

Primary outcomes:
measure: insulin sensitivity (insulin profile)
timeFrame: change from baseline to 24 weeks
Secondary outcomes:
measure: aerobic capacity
timeFrame: change from baseline to 24 weeks
measure: aerobic capacity - lactate concentrations
timeFrame: change from baseline to 24 weeks
measure: cytokine profile
timeFrame: change from baseline to 24 weeks
measure: walking performance
timeFrame: change from baseline to 24 weeks
measure: Self-reported measures
timeFrame: Change from baseline to 24 weeks
measure: body composition
timeFrame: Change from baseline to 24 weeks
measure: muscle strength of knee flexor
timeFrame: change from baseline to 24 weeks
measure: muscle strength of knee extensor
timeFrame: change from baseline to 24 weeks
measure: muscle strength of elbow flexor
timeFrame: change from baseline to 24 weeks
measure: muscle strength of elbow extensor
timeFrame: change from baseline to 24 weeks
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: REVAL
Study officials:
affiliation: Reval/Biomed, Hasselt University
name: Inez Wens, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Reval/Biomed, Hasselt University
name: Bert Op't Eijnde, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00639392: Phase 1 Study of Zoledronic Acid in Sickle Cell Disease
Official title: Phase 1 Study of Zoledronic Acid in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Sickle Cell Disease
Keywords: Sickle cell disease
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2008-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The long-term goal of this study is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease. The goal of this study is to learn about the safety of Zoledronic Acid in persons with sickle cell disease who experience chronic pain requiring medical treatment or use of narcotics.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Male or female with sickle cell disease
* Pain related to sickle cell disease Patient history of health services utilization for acute SCD-related pain Patient history of use of narcotic analgesics for pain control within the past 6 months
* Able to tolerate hydration with 500 mL D51/2 NS prior to Zoledronic Acid or placebo

Exclusion Criteria:

* Calculated creatinine clearance less than 60 mL/min
* Current active dental problems
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction,implants)
* History of cirrhosis or chronic symptomatic liver disease; acute liver disease
* History of aspirin-induced asthma
* History of allergy to zoledronic acid or similar chemical-entities
* Pregnant or nursing
* No prior bisphosphonate use
* Receipt of an investigational drug within 30 days

Primary outcomes:
measure: The long-term goal of this project is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease.
timeFrame: Within 2 weeks of study drug administration and then every month for approximately 1 year
Secondary outcomes:
measure: The specific purposes of this study are to learn if Zoledronic Acid has serious side effects for subjects with sickle cell disease and to study the effects of Zoledronic acid in subjects with sickle cell disease.
timeFrame: Two weeks after study drug administration and then every month for approximately 1 year
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: John D Roberts, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054092: A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients
Official title: Long-term Study of ASP1941 - A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Blood glucose
ASP1941
Food effect
Diabetes mellitus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 182
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: The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.

Detailed description: Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients for at least 12 weeks
* HbA1c value between 6.5 and 9.5%
* Body Mass Index ( BMI )20.0 - 45.0kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
* Proliferative diabetic retinopathy

Primary outcomes:
measure: HbA1c
timeFrame: For 52 weeks
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: For 52 weeks
measure: Fasting serum insulin
timeFrame: For 52 weeks
measure: Plasma levels of ASP1941 for population PK analysis
timeFrame: For 52 weeks
measure: Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs
timeFrame: For 52 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02456792: IVF Versus LOD in Women With CC Resistant PCOS
Official title: In Vitro Fertilization Versus Laparoscopic Ovarian Drilling in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infertility
Polycystic Ovarian Syndrome
Keywords: PCOS
Clomiphene citrate resistant
LOD
IVF
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Detailed description: Women will be randomly divided into two groups; IVF group and LOD group. Women in the IVF group will undergo one full IVF cycle. Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.

Eligibility criteria: Inclusion Criteria:

* Infertile women with PCOS as defined by the Rotterdam criteria.
* CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria:

* Age \< 20 or \> 35 years.
* Presence of any infertility factor other than anovulatory PCOS.
* Previous history of ovarian surgery or surgical removal of one ovary.
* Previous exposure to cytotoxic drugs or pelvic irradiation.
* Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
* Metabolic or hormonal abnormalities.

Primary outcomes:
measure: Live birth rate
timeFrame: 9 months
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6-8 weeks gestational age
measure: Multifetal pregnancy rate
timeFrame: 12 weeks gestational age
measure: Miscarriage rate
timeFrame: 12 weeks gestational age
measure: Incidence of early ovarian hyperstimulation syndrome (OHSS)
timeFrame: Within 9 days of final triggering of oocyte maturation
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Fertility Care Unit (FCU) in Mansoura University Hospital
state: Dakahlia
city: Mansoura
country: Egypt
facility: Private fertility care centers
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Ahmed Gibreel, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02161692: Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors
Official title: Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Testicular Neoplasms
Germ Cell Tumors
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2014-06-12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
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 determine whether the use of a sequential high dose chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide, and bleomycin \[PEB\]) in patients with metastatic poor prognosis germ cell tumors.


Eligibility criteria: Inclusion Criteria:

* Clinical or Histological diagnosis of germ cell tumors
* Metastatic disease
* Poor prognostic category according to the International Germ Cell Collaborative Group (IGCCCG) classification
* No prior chemotherapy for metastatic disease

Exclusion Criteria:

* Unwillingness to accomplish the study procedures
* Any existing co-morbidity that could limit the administration of high dose chemotherapy
* Any psychiatric disorder that could impact on the study compliance

Primary outcomes:
measure: Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori
Study officials:
affiliation: Istituto Nazionale dei Tumori, Milano Italy
name: Andrea Necchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lorch A, Bascoul-Mollevi C, Kramar A, Einhorn L, Necchi A, Massard C, De Giorgi U, Flechon A, Margolin K, Lotz JP, Germa-Lluch JR, Powles T, Kollmannsberger C, Beyer J. Conventional-dose versus high-dose chemotherapy as first salvage treatment in male patients with metastatic germ cell tumors: evidence from a large international database. J Clin Oncol. 2011 Jun 1;29(16):2178-84. doi: 10.1200/JCO.2010.32.6678. Epub 2011 Mar 28.
citation: Necchi A, Mariani L, Di Nicola M, Lo Vullo S, Nicolai N, Giannatempo P, Raggi D, Fare E, Magni M, Piva L, Matteucci P, Catanzaro M, Biasoni D, Torelli T, Stagni S, Bengala C, Barone C, Schiavetto I, Siena S, Carlo-Stella C, Pizzocaro G, Salvioni R, Gianni AM. High-dose sequential chemotherapy (HDS) versus PEB chemotherapy as first-line treatment of patients with poor prognosis germ-cell tumors: mature results of an Italian randomized phase II study. Ann Oncol. 2015 Jan;26(1):167-172. doi: 10.1093/annonc/mdu485. Epub 2014 Oct 24.
Clinical trial NCT01022892: Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair
Official title: Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endovascular Abdominal Aortic Aneurysm Repair
Keywords: Endovascular
Abdominal
Aortic
Aneurysm
Repair
Surveillance
EVAR
CT
Scan
Endoleaks
Contrast
Enhanced
Ultrasound
Definity
AAA
imaging
No Endoleaks
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent EVAR at The Ottawa Hospital and are currently undergoing post-EVAR surveillance will be eligible for the study.

Brief summary: The purpose of this study is to support the suspected expectation that Contrast enhanced Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT), and also find a number of leaks missed by CT.

The investigators' primary goal is to detect no difference between CT and CUS and provide evidence that CUS is a possible alternative to CT.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent EVAR at The Ottawa Hospital and currently under post-EVAR surveillance at The Ottawa Hospital.

Exclusion Criteria:

* Unable to consent for injection of contrast
* Unable to acquire IV access
* Right-to-left, bi-directional, or transient right-to-left cardiac shunts
* Severe pulmonary disease
* Previous hypersensitivity to DEFINITY® or its components
* Unable to be followed as a outpatient by the Vascular Diagnostic Center

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Ottawa Hospital - Division of Vascular & Endovascular Surgery
name: Sudhir Nagpal, MD
role: PRINCIPAL_INVESTIGATOR
References: