louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04006782: Narrow Dental Implants in Multiple Fixed Prosthesis: A Controlled Clinical Trial
Official title: Narrow Dental Implants in Multiple Fixed Prosthesis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Edentulous Alveolar Ridge
Keywords: edentulous
narrow alveolar ridges
Lead sponsor: Fundación Eduardo Anitua
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the survival of narrow dental implants (≤ 3,5 mm) in multiple fixed prostheses in comparison with standard diameter dental implants (≥ 3,75 mm) after 5 years of follow-up. The hypothesis of the study is that narrow dental implants under the evaluated conditions, have the same survival rate and clinical performance than the standard diameter implants.


Eligibility criteria: Inclusion Criteria:

* Patients of legal age (\>18 years) of both sexes.
* Clinical need of multiple fixed alveolar ridge rehabilitations.
* Clinical suitability to insert, at least, one narrow dental implant splinted to a standard diameter dental implant.
* Signature of the informed consent

Exclusion Criteria:

* Presence of an active infection
* Being under active treatment with, or have received in the las 30 days treatment with radiotherapy, chemotherapy, immunosuppressors, systemic corticosteroids and/or anticoagulants.
* Presence of severe haematologic disorders.
* Chronic treatment with non steroidal anti-inflammatory drugs (NSAID) or other aniinflammatory drugs.
* Previous diagnosis of chronic hepatitis or liver cirrhosis.
* Presence of Diabetes mellitus with improper metabolic control (glycosylated haemoglobine higher that 9%).
* Patients subjected to dialysis.
* Presence of malignant tumours, haemangioma or angioma in the surgical area.
* History of ischaemic cardiopathy in the las year.
* Pregnancy or plan to getting pregnant during the study.
* Metabolic bone disease
* Patientd receiving treatment with oral or intravenous biphosphonates.
* Any other condition incompatible with the participation in the study,

Primary outcomes:
measure: Survival after 5 years of follow-up
timeFrame: 5 years in comparison with the baseline
Secondary outcomes:
measure: Marginal Bone Loss
timeFrame: 1, 3 and 5 years in comparison with the baseline
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Clínica Dental Eduardo Anitua
Study officials:
References:
Clinical trial NCT02578082: Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment
Official title: The Effect of Severe Renal Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD 4208
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Renal Impairment
Renal Insufficiency
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2015-10-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal renal function or severe (eGFR \<30 mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the pharmacokinetics (PK) of TD 4208.


Eligibility criteria: Inclusion Criteria:

For renal impairment group:

* Subject has severe renal impairment (eGFR \<30 mL/min/1.73 m2)

For normal renal function group:

* Subject is in good health

Exclusion Criteria:

* Women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study.
* Subject has received an investigational drug (or medical device) within 30 days
* Subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose
Secondary outcomes:
measure: Adverse Events (AE)
timeFrame: From the time of study drug administration through the end of the study (Day 5 or early termination)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center (OCRC)
state: Florida
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Borin MT, Lo A, Barnes CN, Pendyala S, Bourdet DL. Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function. Int J Chron Obstruct Pulmon Dis. 2019 Oct 8;14:2305-2318. doi: 10.2147/COPD.S203709. eCollection 2019.
Clinical trial NCT04950582: In Vitro Analysis of Human Urine With the CloudCath Device
Official title: In Vitro Analysis of Human Urine With the CloudCath Device
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Urinary Tract Infections
Lead sponsor: CloudCath
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with indwelling urinary catheters

Brief summary: This is a multi-center feasibility study to assess the in vitro function of the CloudCath Device that is being developed to derive clinically-relevant information from the optical characteristics of urine.

Detailed description: Specimens will be obtained from participants with indwelling catheters in hospital or home settings, who are suspected to be at high risk for urinary tract infection.

To evaluate the performance of the CloudCath Device in repeated measurements over time, multiple specimens may be obtained from the same patients over multiple days or months.

Each sample will be divided into multiple aliquots. One part will be analyzed using the CloudCath Device and reference devices. Another part may be submitted to an independent lab for standard analytical tests.

Eligibility criteria: Inclusion Criteria:

* provide a signed informed consent
* patient has an implanted urinary catheter (i.e., Foley, Texas, ureteral)

Exclusion Criteria:

* any condition that the investigator feels may confound the study results or place the participant at risk by participating in the study
* currently taking antibiotics for any reason other than for treatment of urinary tract infection (UTI)
* suprapubic bladder catheter implanted

Primary outcomes:
measure: Spectral characteristics of urine specimens
timeFrame: During the period of time that the patient is catheterized (expected to be up to ~1 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: CloudCath Investigational Site
state: Jalisco
Study officials:
affiliation: University of California, San Francisco
name: Ben Briggs, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01172782: The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Measurement
Visual Analog Pain Scale
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Korea University
First posted: 2010-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone injection for postoperative pain relief after knee arthroscopic surgery.

Detailed description: Sixty patients who were undergoing unilateral knee arthroscopy randomly received unilateral spinal anesthesia with 0.5% hyperbaric bupivacaine 6 mg combined with normal saline 0.05 mL or hydromorphone 2.5, 5 or, 10 μg/0.05 mL. The verbal numerical rating scale (VNRS) pain scores were measured at 30 minutes and 2, 4, 6, 12 and 24 hours postoperatively, and the side effects of hydromorphone were recorded.

Eligibility criteria: Inclusion Criteria:

* ASA class I-II (age range: 18-72 years)
* Informed consent obtained patients

Exclusion Criteria:

* The exclusion criteria included evidence of neurological or neuromuscular disease, respiratory or cardiac disease, diabetes mellitus or peripheral neuropathy, as well as those patients who were receiving chronic analgesic therapy or who had infection at the intended site of spinal needle insertion or who had hypersensitivity to amide local anesthetics or opioids

Primary outcomes:
measure: Visual Analgesic Numberic Score
timeFrame: during postoperative recovery period.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lee YS, Park YC, Kim JH, Kim WY, Yoon SZ, Moon MG, Min TJ. Intrathecal hydromorphone added to hyperbaric bupivacaine for postoperative pain relief after knee arthroscopic surgery: a prospective, randomised, controlled trial. Eur J Anaesthesiol. 2012 Jan;29(1):17-21. doi: 10.1097/EJA.0b013e3283476055.
Clinical trial NCT06437782: Exploration of Health Literacy in Diabetes in Reunion Island and France
Official title: Exploration of Health Literacy in Diabetes in Reunion Island and Metropolitan France
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes type1
Diabetes Type 2
Diabetes, Gestational
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes (strict insulin dependence, or anti-GAD, anti-IA2, and/or anti-ZnT8 + antibodies) with a hybrid closed-loop insulin therapy system for at least 3 months , diabetes of type 2 (non-insulin-dependent or insulin-requiring, with negative anti-GAD, anti-IA2, and/or anti-ZnT8 Ab if diabetes has been diagnosed for less than 5 years at the time of insulin therapy), or diabetes during pregnancy: gestational diabetes (diabetes diagnosed during pregnancy according to the diagnostic criteria of French recommendations), or pre-existing diabetes (known or not) with pregnancy.

Brief summary: The goal of this observational study is to identify the health literacy profile of diabetic patients in Reunion Island and France in order to obtain information to improve access to information, therapeutic education and to health service. The main question\[s\] it aims to answer \[is/are\]:

Participants will complete the Health Literacy Questionnaire (HLQ) once.


Eligibility criteria: Inclusion Criteria:

Patient with type 1, 2 or gestational diabetes taken care in hospital

Exclusion Criteria:

* Patient unable to understand and respect study procedures
* Patient with cognitive disorder
* Patient with serious acute complication due to diabetes within 15 days before inclusion
* Stroke history with neurologic consequences
* Other specific types of diabetes : chronic calcific pancreatitis, iatrogenic, other secondary diabetes, rare monogenic or genetic diabetes due to insulin resistance

Primary outcomes:
measure: Health literacy profiles in Reunion Island
timeFrame: at inclusion
Secondary outcomes:
measure: Health literacy profiles in Reunion Island and France
timeFrame: at inclusion
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de La Réunion
Study officials:
References:
Clinical trial NCT00144482: A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
Official title: A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy Induced Anemia
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy


Eligibility criteria: Inclusion Criteria:

* Cancer patients

Exclusion Criteria:

* a history of myocardial, cerebral or pulmonary infarction
* severe hypertension beyond control by drugs

Primary outcomes:
measure: The increase in Hb concentration
timeFrame: week 8
Secondary outcomes:
measure: Changes in QOL scores
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Yoshiharu Ishikura
role: STUDY_DIRECTOR
References:
Clinical trial NCT04840082: Optimal Length for Nasal Mid-turbinate and Nasopharyngeal Swabs
Official title: Optimal Insertion Length for Nasal Mid-turbinate and Nasopharyngeal Swabs for Respiratory Virus Infection Diagnostic Testing - a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 109
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aim to explore the optimal swap insertion length for mid-turbinate and nasopharyngeal samples. Our clinical trial took place at a Covid-19 test center in Copenhagen. Participants consisted of voluntary citizens who were at the test center for a nasopharyngeal antigen quicktest. An endoscopic examination was performed simultaneous with the swap to measure the length from the vestibulum nasi to the posterior wall of the nasopharynx and the mid-turbinate.


Eligibility criteria: Inclusion Criteria:

* Referred for COVID-19 testing

Exclusion Criteria:

* Nose patology

Primary outcomes:
measure: Length from the vestibulum nasi to the posterior wall of the nasopharynx.
timeFrame: From inclusion at the testcenter until the COVID-19 testing was completed.
measure: Length from the vestibulum nasi to the mid-turbinate.
timeFrame: From inclusion at the testcenter until the endoscopic examination was completed
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Copenhagen East
Study officials:
References:
Clinical trial NCT06202482: Enhance Physical Activity and Intergenerational Relationship Via Connect Active Program (CAP): a Pilot Randomized Controlled Trial
Official title: Enhance Physical Activity and Intergenerational Relationship Via Connect Active Program (CAP): a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Physical Inactivity
Keywords: Connective Active Program
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 40
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: This study investigates how walking exercises and technology could enhance the quality of life in the older generation. It has three objectives: 1) To examine the effectiveness of the Connect Active Program (CAP) in improving intergenerational relationships, psychological well-being, and physical fitness for older adults; 2) To teach older adults to use mobile apps; 3) To examine the experiences and feedback from participants in using the apps and joining the CAP. This research will provide long-term insights into improving the overall health outcomes of older adults via intergenerational support and increasing the acceptance of mobile technology among older adults.


Eligibility criteria: Inclusion Criteria:

* Younger Adults/Participants:

  * Aged 18 to 30
  * Related to the older adult participant (i.e. family member, relatives)
  * Able to understand Cantonese
  * Own a smartphone and have access to the Internet
  * Able to take part in walking exercise and stretching program
* Older Adults/Participants:

  * Aged 60 or above
  * Able to understand Cantonese
  * Own a smartphone and have access to the Internet
  * Capable to participate in walking exercise and stretching program

Exclusion Criteria:

* Older Adults/Participants and Younger Adults/Participants:

  * Diagnosed with a mental disorder by neurologists or psychiatrists
  * With a history of drug addiction

Primary outcomes:
measure: Aerobic Capacity and Endurance Evaluation with 6-Minute Walk Test (6MWT)
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Mobility and Balance Assessment with Time Up and Go Test
timeFrame: Baseline, Week 6
measure: Quality of Life Measurement
timeFrame: Baseline, Week 6
measure: Happiness Level Determination
timeFrame: Baseline, Week 6
measure: Intergenerational Relationship Appraisal
timeFrame: Baseline, Week 6
measure: Subjective Quality Assessment of Mobile Apps
timeFrame: Baseline, Week 6
measure: Participant Feedback Collection
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Hong Kong Metropolitan University
Study officials:
affiliation: School of Nursing and Health Studies, Hong Kong Metropolitan University
name: Mimi MY Tse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06008782: HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment
Official title: HEARS-SLP: Providing Speech Language Pathologist-Delivered Hearing Health Care to Individuals With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Dementia
Cognitive Impairment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Building upon the HEARS audiologist-community health worker (CHW) model, this study intervention will be delivered by a speech-language pathologist (SLP). The primary objective of the study is to develop and test an affordable and accessible hearing rehabilitative intervention that will be delivered by a SLP to individuals with cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Age 60 - 100 years old
* English-speaking
* Lives at home
* Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines
* Availability of caregiver/study partner to participate in all study-related visits and who provides ≥8 hours of weekly oversight/care
* Speech frequency pure tone average (0.5- 4 kHz) \>25 db in the better-hearing ear; adult onset hearing loss
* Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms

Exclusion Criteria:

* Current self-reported use of hearing aid or amplification device
* Medical contraindication to use hearing aids ( e.g. draining ears)
* Inability to participate in the 1-month follow up

Primary outcomes:
measure: Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)
timeFrame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
Secondary outcomes:
measure: Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale
timeFrame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
measure: Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)
timeFrame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Esther Oh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05898282: Prevalence and Associated Factors of Anesthetic Drug Administration Error, a Web Based Crossectional Survey, 2022.
Official title: Prevalence and Associated Factors of Anesthetic Drug Administration Error Among Anesthetists Working in Teaching and Referral Hospitals of Ethiopia, a Web Based Crossectional Survey, 2022.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frequency of Anesthetics Drug Administration Error by Anesthetists
Keywords: Anesthetic drug, medication admnistration, medication admnistration, medication admnistration error
Lead sponsor: DebreTabor University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 255
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all volunteer anesthetists with a minimum of six months of working experience and able to respond to the questionnaire using the listed online choices.

Brief summary: The operating room (OR) is a demanding and time-constrained setting, in comparison to primary care settings, where perioperative medication administration is more complicated and there is a high risk that the patient will experience a medication error.

Without consulting the pharmacist or seeking assistance from other staff members, anesthesia clinicians prepare, deliver, and monitor strong anesthetic drugs.

Detailed description: The operating room (OR) is a demanding and time-constrained setting, in comparison to primary care settings, where perioperative medication administration is more complicated and there is a high risk that the patient will experience a medication error. Anesthesia clinicians prepare, deliver, and monitor strong anesthetic drugs without consulting pharmacists or seeking assistance from other staff members.

The aim of this study was to determine the prevalence of medication administration errors by anesthetists and associated factors in referral and teaching hospitals in the Amhara region of, Ethiopia.

Eligibility criteria: Inclusion Criteria:

* all anesthetists with a minimum of six months of working experience, the ability to respond to the questionnaire using the listed online choices, and involvement in direct patient care to be included in the study.

Exclusion Criteria:

* Anesthetists who were not involved in medication administration and those serving in administrative positions were excluded from the study.

Primary outcomes:
measure: Prevalence of anesthetics drug administration error by anesthetists working in Amhara region, Ethiopia
timeFrame: October 1-November 30, 2022
Secondary outcomes:
measure: factors associated with medication administration errors by anesthetists
timeFrame: October 1-November 30, 2022
Other outcomes:
Locations:
city: Debre Tabor
country: Ethiopia
facility: Debre Tabor University
Study officials:
References: