louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01515358: A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants
Official title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 18
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination

Primary outcomes:
measure: Number of participants with one or more drug related adverse events (AEs) or any serious AEs
timeFrame: Baseline to study completion (estimate 3 months)
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328
timeFrame: Pre-dose up to Day 6 post-dose
measure: Pharmacokinetics: Maximum concentration (Cmax) of LY3000328
timeFrame: Pre-dose up to Day 6 post-dose
measure: Change in Cathepsin S (CatS) activity
timeFrame: Pre-dose, up to 48 hours post-dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00761358: To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia
Official title: To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Dyspepsia
Keywords: Acotiamide
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 820
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.


Eligibility criteria: Inclusion Criteria:

* Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal discomfort, epigastric pain, epigastric burning) for at least 6 months before obtaining informed consent
* Subjects showing two or more of the following symptoms: upper abdominal pain, upper abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety, nausea, vomiting and/or excessive belching for at least 3 months (one of them should be post-prandial fullness or early satiation)
* Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or early satiety at the time of obtaining informed consent

Exclusion Criteria:

* Subjects with structural disease that is likely to explain the symptom (e.g., GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed by upper endoscopy at the obtaining informed consent
* Subjects have heartburn in last 12 weeks before obtaining informed consent
* Subjects with irritable bowel disease (IBS)
* Subjects with diabetes mellitus requiring treatment
* Subjects with serious anxiety disorder
* Subjects with depression and/or sleep disorder
* Subjects with biliary tract disease and/or pancreatitis (including chronic pancreatitis)

Primary outcomes:
measure: General impression at last visit in treatment period
timeFrame: 4 week
measure: Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period
timeFrame: 4 week
Secondary outcomes:
measure: Individual symptom score
timeFrame: Every week
measure: SF-NDI
timeFrame: At 0, 4 week and 4 week after treatment
measure: General Impression
timeFrame: Every week
measure: Laboratory tests
timeFrame: At 0, 4 week and 4 week after treatment
measure: Adverse Event
timeFrame: 4 week treatment period and 4 week after treatment
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Tohoku University Hospital
name: Michio Hongo, Professor
role: STUDY_DIRECTOR
References:
citation: Matsueda K, Hongo M, Tack J, Saito Y, Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2012 Jun;61(6):821-8. doi: 10.1136/gutjnl-2011-301454. Epub 2011 Dec 9.
Clinical trial NCT06622863: EFFECTIVENESS OF ORAL HYGIENE INSTRUCTIONS GIVEN BY AI-GENERATED VIDEOS VS. TRADITIONAL APPROACH IN PERIODONTAL PATIENTS
Official title: EFFECTIVENESS OF ORAL HYGIENE INSTRUCTIONS GIVEN BY AI-GENERATED VIDEOS VS. TRADITIONAL APPROACH IN PERIODONTAL PATIENTS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingivitis
Periodontitis
Lead sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients attending Dubai Dental Hospital and requiring nonsurgical periodontal therapy will be invited to take part in the study. Potential participants will be screened and selected based on the inclusion and exclusion criteria

The aims of the randomized controlled trial are:

1. To compare the influence of AI-generated instructions versus traditional methods in improving the oral hygiene habits of patients diagnosed with periodontitis
2. To assess the time and cost effectiveness of applying AI-generated oral hygiene instructions in daily practice
3. To evaluate the level of patients' engagement, preference, and satisfaction with technology-based interactions vs. patient-doctor interaction

Research design

* Prospective, in which participants will be recruited and then followed up throughout a specified period of time.
* Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups.

The study will involve two stages, 1) Digital Avatar creation and 2) Clinical component.

The participants will be randomly allocated to two equal sized groups (30 per group) using computer-generated numbers:

Control group (C): Standard oral hygiene instructions will be given verbally by the periodontics resident.

Test group (T): Avatar-based group will receive oral hygiene instructions from a digital avatar of their choice.


Eligibility criteria: Inclusion Criteria:

Aged 18 or over.

Diagnosed with gingivitis or generalized periodontitis, Stage I-IV and Grade A-C.

Good compliance and commitment to attend follow-up review appointments.

Willing to provide informed consent.

Exclusion Criteria:

Received periodontal treatment in the last 12 months.

Received systemic anti-inflammatory or antibiotic treatment in the last 3 months.

History of malignancy, radiotherapy, or chemotherapy.

Pregnant or lactating women.

Use of medication known to cause gingival overgrowth.

Participants that require prophylactic antibiotic.

Primary outcomes:
measure: Plaque and bleeding score
timeFrame: At baseline and after 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02838563: Validation of a Scale of Well-Being Assessment (SIWA) in Patients With Alzheimer's Disease or a Related Disease.
Official title: Validation of a Scale of Well-Being Assessment (SIWA) in Patients With Alzheimer's Disease or a Related Disease.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Well-Being
Keywords: Dementia
Alzheimer
Well-Being
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 135
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an Alzheimer Disease or related disorder living in nursing home

Brief summary: Current scales are not suited to a direct measure for the elderly with cognitive disorders and are difficult to handle for the care teams. In this context, a visual analog scale was created to answer a single question "How are you feeling now, immediately?" with the help of pictograms. This study aims to assess the validity and reliability of the Scale of Well-Being Assessment (SIWA) (in french : Echelle d'Evaluation Instantanée du Bien-Etre (EVIBE)) in people with Alzheimer's disease or a related disease.


Eligibility criteria: Inclusion Criteria:

* Enrolled patients must have given themselves, or through a trusted person referred to the Article L. 1111-6 of the Code of Public Health, failing thereof, by the family, or, a person maintaining close and stable ties. For adults under guardianship, permission must be given by the legal representative of the person. The research will benefit from the backing of persons Protection Committee (PPC) prior to its implementation.
* Patient living in one of the nursing home or hospital services in the project;
* Patient with Alzheimer's or a related disease

Exclusion Criteria:

* severe, progressive or unstable pathology, which may interfere with the evaluation variables;
* deafness or blindness may compromise patient assessment

Primary outcomes:
measure: Correlation between SIWA and an other quality of life scale (Qol-AD)
timeFrame: the Qol-AD is collected once. (Day 1)
Secondary outcomes:
measure: Stability over time of SIWA
timeFrame: The SIWA is collected twice at ten minute intervals (Day 1)
measure: Correlation between SIWA and an health scale (EQ-5D)
timeFrame: the EQ-5D is collected once. (Day 1)
measure: Correlation between SIWA and behavioral and psychological symptom of dementia (BPSD) (NPI)
timeFrame: the NPI is collected once. (Day 1)
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Centre de Recherche Clinique " Vieillissement-Cerveau-Fragilité ", Hôpital des Charpennes, Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Pierre Krolak-Salmon, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02301663: Development of a Novel Stress Testing Protocol to Define the Relationship Between Coronary Microvascular Dysfunction and Diastology in Women With Angina But No Evidence of Obstructive Coronary Artery Disease
Official title: DEVELOPMENT OF A NOVEL STRESS TESTING PROTOCOL TO DEFINE THE RELATIONSHIP BETWEEN CORONARY MICROVASCULAR DYSFUNCTION AND DIASTOLOGY IN WOMEN WITH ANGINA BUT NO EVIDENCE OF OBSTRUCTIVE CORONARY ARTERY DISEASE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Microvascular Coronary Dysfunction
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain, primarily impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. The investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). Subjects will undergo a series of "stress" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

1. Fully understanding and willing to undergo study procedures
2. Male or Female greater than or equal to 18 years of age
3. Understanding and willing to sign consent form.

Exclusion Criteria:

1. History of cardiovascular, pulmonary, or neurological disease
2. Hypertension (sitting blood pressure \>140/90 mmHg, with measurements recorded on at least 2 occasions)
3. Diabetes
4. Unable to give informed consent;
5. Contra-indication to CMRI testing, including claustrophobia and metallic implants
6. Adherence or retention issues;
7. Women who are pregnant.
8. Allergy to animal dander.

Primary outcomes:
measure: Diastolic function by MRI
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Michael Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04434963: Safety and Feasibility of Reversible Induction Strategy
Official title: Safety and Feasibility of Reversible Induction Strategy Supported by HFNC Combined With Specific Anesthetic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Uncertain Difficult Airway
Colon Cancer
Gastric Cancer
Prostatic Cancer
Keywords: THRIVE
Uncertain difficult airway
Reversible induction strategy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an uncertain difficult airway, who will undergo a selective operation and need trachea intubtion.

Brief summary: This study would explore the safety and feasibility of a reversible induction strategy for uncertain difficult airway. This reversible induction strategy would include high flow nasal canular oxygenation support, short-term effect anesthetic including Propofol and Remifentanil for sedation and analgesia and Sugammadex would be used for reverse the muscle relaxant.


Eligibility criteria: Inclusion Criteria:

* \>18 years old,\<65 years old
* Signed informed consent
* Undergoing selective operation （ time of operation is over two hours）
* ASA classification I-II
* Mallampati classification 3-4
* suspicious difficult airway, but the anesthetists decide to try to rapid induction

Exclusion Criteria:

* Patients with several dysfunctions of liver, kidney or heart)
* Patients with a full stomach or have other risk factors of reflux aspiration
* Any medicine was taken before surgery, which might enhance or mitigate the effects of muscle relaxant
* Infection of the mouth or nose
* Allergy history of any medicine which would be used in this study
* Pregnant and lactating women
* Patients with neuromuscular disease

Primary outcomes:
measure: Successful rate of reversion
timeFrame: From the beginning of induction to 15min later
Secondary outcomes:
measure: TOFr 0.9 reversion time
timeFrame: From the beginning of induction to 15min later
measure: BIS 80 reversion time
timeFrame: From the beginning of induction to 15min later
measure: Tidal volume 6-8ml tidal volume 6-8ml/kg reversion time
timeFrame: From the beginning of induction to 15min later
measure: consciousness reversion time
timeFrame: From the beginning of induction to 15min later
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, Shanghai Jiaotong University, Shanghai, China
name: diansan su
role: STUDY_DIRECTOR
References:
Clinical trial NCT00976963: Single Dose Monurol for Treatment of Acute Cystitis
Official title: Single Dose Monurol for Treatment of Acute Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Keywords: UTI
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-09-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20's. One of the most common antibiotics used to treat UTIs is Trimethoprim-Sulfamethoxazole (TMP-SMX), usually for total of three days. However, concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for UTI.

An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied. The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.

Detailed description: Procedures subjects will undergo once they have read and signed the consent are:

Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-8 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.

Eligibility criteria: Inclusion Criteria:

* Non pregnant women in good health with symptoms of acute cystitis for less than 7 days

Exclusion Criteria:

* Pregnant, lactating, or not regularly contracepting
* History of chronic conditions such as diabetes
* Known anatomic abnormalities of the urinary tract
* Use of prophylactic antibiotics
* History of allergy or intolerance to any of the study drugs
* Recent (\> 2 weeks)exposure to oral or parenteral antimicrobial
* History of UTI in previous 1 month

Primary outcomes:
measure: Number of Participants Who Were Cured
timeFrame: 28-30 days post therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of WA
name: Ann E. Stapleton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03185663: Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur
Official title: Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Fractures
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a pillow between the legs versus traction-stuck
Primary purpose: OTHER

Brief summary: The fracture of the proximal femur is a common traumatic pathology in patients aged over 70 years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing antiescarres slippers. Mobilization, source of pain, is also problematic.

759/5000


Eligibility criteria: Inclusion Criteria:

* Patient aged 70 and over,
* Extracapsular fracture isolated from the proximal end of the femur,
* Informed consent of the patient for participation in the study,
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Restlessness or fragile skin condition that may prevent the establishment or maintenance of traction stuck preoperatively
* Insane or confounding Pathology,
* Predictable time before operation\> to 72 hours (eg anticoagulated patient orally before the fracture \[antiplatelet agents are allowed\], other associated diseases: urinary tract infection, pneumonia ...)
* Patient under guardianship, curatorship, or under judicial protection.

Primary outcomes:
measure: Score from pain immediately after washing, the day of surgery preoperatively
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges Hospital
Study officials:
References:
Clinical trial NCT01243463: Bariatric Surgery and Obstructive Sleep Apnea
Official title: Effects of Bariatric Surgery on Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Bariatric Surgery
Lead sponsor: Summa Health System
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese women, 20 - 85 years of age

Brief summary: More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two conditions separately, and these treatment modalities both present a unique set of challenges in terms of patient-adherence. Furthermore, the combined effects of these therapies on body weight and OSA severity are unclear, and require longitudinal investigation. The purpose of the research proposed herein is twofold: A) To prospectively demonstrate the specific physiologic/psychological improvements in OSA risk factors and disease severity that occur in a subset of bariatric surgery patients with OSA, who are being effectively treated with PAP and furthermore; B) To elucidate differences in postoperative outcomes (weight-loss, dyslipidemia, OSA severity, comorbidity resolution) between patients who are compliant or non-compliant with prescribed PAP therapy. The investigators anticipate that results will be used to develop and streamline approaches to improve pulmonary/sleep-related outcomes in bariatric surgery patients. Furthermore, this line of research has many implications for strategies to strengthen the coordination of care between bariatric surgery, pulmonology, and other clinical sub-specialties that are integral to the postoperative health of these patients.


Eligibility criteria: Inclusion Criteria:

* obese (Body Mass Index \> 35)
* pending laparoscopic roux-en-Y gastric bypass at Summa Bariatric Care Center
* women
* ages 20 - 85
* diagnosed OSA and prescribed nocturnal, autotitrating positive airway pressure therapy

Exclusion Criteria:

* are excluded if failure to meet any of the above

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Health System Akron City Hospital
state: Ohio
Study officials:
References: