louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05727072: A Study of LY3848575 in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics With Single Intravenous Ascending Doses and Single and Multiple Subcutaneous Doses of LY3848575 in Healthy Participants, Including First-generation Japanese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-02-14
Enrollment: 64
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: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3848575 when administered either intravenously or subcutaneously in single ascending or multiple doses in healthy non-Japanese and first generation Japanese participants. The study will also assess how fast LY3848575 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 142 days excluding the screening period of 28 days.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Have body weight of at least 50 kilograms (kg) for males and 40 kg for females, and body mass index of 18 to 30 kilograms per meter squared (kg/m²), inclusive
* For cohorts with Japanese participants: To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan

Exclusion Criteria:

* Are currently enrolled in any other clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have participated, within the last 3 months, in a clinical study involving an IP.

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through 142 days
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3848575 When Administered IV.
timeFrame: End of infusion through day 85
measure: PK: AUC of LY3848575 When Administered SC.
timeFrame: Predose through day 85
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
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 NCT05208372: Detection of CTC and ctDNA in the Diagnosis of Metastasis in Gastric Cancer
Official title: Application of the Detection of Circulating Tumor Cell and Circulating Tumor DNA in the Diagnosis of Metastasis in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasms
Metastasis
Keywords: Diagnosis
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Borrmann III and Borrmann IV patients will be selected from Department of Oncology in hospitals. All patients will undergo either laparotomy or laparoscopic surgery.

Brief summary: To investigate the value of CTCs and ctDNA in the diagnosis of metastasis in ascites/peritoneal flushing fluid and blood; To investigate the influence of laparoscopic CO2 pneumoperitoneum establishment on peritoneal and hematogenous metastasis of advanced gastric cancer; To explore the influence of the number and type of CTCs and ctDNA on metastasis and prognosis.


Eligibility criteria: Inclusion Criteria:

1. Patients who sign informed consent.
2. Gastric cancer is determined by more than 2 pathologists.
3. Patients with Borrmann III/IV gastric cancer.

Exclusion Criteria:

1. Patients who complicate with other malignant tumors.
2. Patients who complicate with other serious heart and lung diseases.
3. Patients who receive preoperative neoadjuvant chemotherapy.

Primary outcomes:
measure: Quantity of CTCs
timeFrame: 1 day
measure: Classification of CTCs
timeFrame: 1 day
measure: Expression of ctDNA
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Jinzhou
country: China
facility: First Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Kai Li, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05135572: Tarsal Tunnel Syndrome and Fibromyalgia
Official title: What is the Relationship Between Tarsal Tunnel Syndrome and Foot Pain in Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tarsal Tunnel Syndrome
Keywords: Tarsal Tunnel Syndrome, Fibromyalgia, Neuropathic pain, EMG
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Widespread pain is observed in patients diagnosed with fibromyalgia, and lower extremity and foot pain are also common. In our study, we aimed to evaluate the relationship between foot pain and tarsal tunnel syndrome in female patients diagnosed with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* 18-65 age
* Diagnosed with fibromyalgia according to ACR criteria

Exclusion Criteria:

* Have any severe mental or psychological disorder
* Have significant hearing and/or vision loss
* Presence of foot deformity, previous fracture, arthritis, tendon pathology that may cause foot pain detected in the physical examination of the foot and ankle joint.
* Presence of systemic inflammatory disease
* Having any systemic disease that may cause polyneuropathy.

Primary outcomes:
measure: Electrodiagnostic studies
timeFrame: 15 minutes
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 3 minutes
measure: Neuropathic Pain Questionnaire.
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Scıence University
state: Kütahya
Study officials:
References:
Clinical trial NCT04007172: Effectiveness of Neural Therapy in Patients With Fibromiyalgia
Official title: Effectiveness of Neural Therapy in Patients With Fibromiyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: neural therapy
physical theraphy
lidocain injection
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neural therapy is a regulation therapy that tries to correct this underlying autonomic dysfunction. In neural therapy; local painful areas, trigger points and symptomatic segments are included in the injection using local anesthetics and the underlying disruptive areas are investigated and treated. The aim of this study was to investigate the efficacy of neural therapy in fibromyalgia syndrome which is thought to have a neuroendocrine dysregulation disorder.

Detailed description: Fibromyalgia is a chronic disease characterized by widespread body pain, fatigue, sleep disturbance, and tenderness on palpation at trigger points in the musculoskeletal system.

Fibromyalgia prevalence is reported between 3% and 9%, and is three times more common in women than men. Although pharmacological and non-pharmacological approaches play a role in the treatment of the disease, the interest in non-pharmacological therapies has recently increased. In several studies, it has been shown that almost every fibromyalgia patient has applied at least one alternative and complementary medicine method such as Qigong, Tai Chi, yoga, mind body interventions, acupuncture, hydrotherapy, balneotherapy or phytotherapy.

Neural therapy is a regulation therapy that tries to correct this underlying autonomic dysfunction. In neural therapy; local painful areas, trigger points and symptomatic segments are included in the injection using local anesthetics and the underlying disruptive areas are investigated and treated. The aim of this study was to investigate the efficacy of neural therapy in fibromyalgia syndrome which is thought to have a neuroendocrine dysregulation disorder.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed according to the American College of Rheumatology 2016 diagnostic criteria for fibromyalgia.

Exclusion Criteria:

* History of comorbid inflammatory rheumatic/ connective tissue diseases
* History of cardiovascular or musculoskeletal problems that could prevent them to participate in an exercise program

Primary outcomes:
measure: Visual analog scale for pain
timeFrame: 4 weeks
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: 4 weeks
measure: Short- form health survey 36 scores
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Tuğba Atan
Study officials:
References:
Clinical trial NCT05589272: TDCS-potentiated Generalization of Cognitive Training in the Rehabilitation of Long COVID Symptoms
Official title: TDCS-potentiated Generalization of Cognitive Training in the Rehabilitation of Long COVID Symptoms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-acute Sequelae SARS-CoV-2 Infection (PASC)
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overarching goals of this study are to employ cognitive testing to understand how transcranial direct current stimulation (tDCS), when used concurrently with cognitive training tasks, can affect cognitive impairment symptoms in individuals with long COVID, or post-acute sequelae SARS-CoV-2 infection (PASC), and to examine variability in response between active and sham tDCS treatment groups.


Eligibility criteria: Inclusion Criteria:

* Ability to provide consent and comply with study procedures
* Age 18 to 60 years old
* Estimated IQ within the specified range (70 \&lt;= IQ E \&lt;= 115)
* Current post-acute sequelae SARS-CoV-2 infection (PASC) as defined by the National Center for Health Statistics post-COVID-19 conditions survey ((Long COVID 2022), including impaired cognition symptoms, for at least 3 months post-infection
* Ability to participate in four weekly 40' training sessions over four weeks and participate in two assessments
* English speaking

Exclusion Criteria:

* Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness \&gt;30 min, concussion involving hospital admission, HIV)
* Contraindications for tDCS (e.g. history of seizures)
* Five or more sessions of neuromodulation (such as tDCS) or cognitive training in the past 6 months

Primary outcomes:
measure: Cognitive improvement effects of WM training with active tDCS vs. sham
timeFrame: baseline and post-test assessment, 4 weeks
measure: Generalization of cognitive effects of active tDCS vs. sham
timeFrame: baseline and post-test assessment, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT05465772: Covid-19 Patients With Hypertension and/or Kidney Diseases
Official title: A Study on COVID-19 Patients With Hypertension and/or Kidney Diseases Admitted to Respiratory ICU , Assiut University Hospitals.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Hypertension
Kidney Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to ICU with positive PCR with Hypertension and/or kidney diseases.

Brief summary: 1. correlation between COVID-19 and Hypertension and/or kidney diseases.
2. Assess Assess the effect of COVID-19 on patients with Hypertension and/or kidney diseases.
3. Assess the effect of hypertension and/or kidney diseases on COVID-19 presentation.
4. Assess the outcome of COVID-19 in patients with hypertension and/or kidney diseases

Detailed description: The pandemic situation with the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from China has endangered human lives. Coronavirus disease 2019 (COVID-19) is presented with asymptomatic, mild, or severe pneumonia-like symptoms¹.SARS-CoV-2 has infected humans in all age groups, of all ethnicities, both males and females while spreading through communities at an alarming rate². COVID-19 patients with hypertension, chronic kidney disease, Diabetes, malignancies, HIV, and other comorbidities could develop a life-threatening situation. From the data have reported the characteristics of comorbidities in patients with COVID-19, hypertension was present in nearly 21%, followed by diabetes in nearly 11%, and established cardiovascular disease (CVD) in approximately 7% of patients³.

Hypertension posed an increased risk of severe morbidity (approx. 4-fold) and death (approx. 7-fold) from COVID-19 in the presence of multiple comorbidities⁴.

The patients with underlying kidney problems are vulnerable to developing COVID-19 infection.The disease also has had consequences on longitudinal management of patients with chronic kidney disease and end stage kidney disease.

Eligibility criteria: Inclusion Criteria:

Patients above 18 years old. Patients who diagnosed as COVID-19 PCR positive with hypertension and/or kidney diseases.

Exclusion Criteria:

Young patients below 18 years old. Patients who refused to participate in reseach

Primary outcomes:
measure: Covid-19 and Hypertension and/or kidney diseases
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01416272: Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
Official title: Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Keratoconus
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.


Eligibility criteria: Inclusion Criteria:

* Have participated and completed a previous study (ROC2-10-078).
* Is Keratoconic

Exclusion Criteria:

* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Is not correctable to 20/50 or better in each eye with contact lenses.
* Has greater than Grade 2 slit lamp exam findings.
* Has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study.
* Has any neovascularization within the central 4mm of the cornea.

Primary outcomes:
measure: Comfort
timeFrame: 4 visits over 1 year
Secondary outcomes:
measure: Visual Acuity - Low Contrast
timeFrame: 4 visits over 1 year
measure: Visual Acuity - High Contrast
timeFrame: 4 visits over 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Robert Steffen, OD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005272: Smoking and Body Weight: Analysis of HHANES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To evaluate the relationships between smoking rate, gender, and body weight in the Hispanic Health and Nutrition Examination I Survey (HHANES) I. Also, to evaluate the independent and additive contribution of smoking rate and fasting glucose on body weight in HHANES I and NHANES II.

Detailed description: BACKGROUND:

The study was supported by the Small Grants Program established by the National Heart, Lung, and Blood Institute in January 1990 to provide limited support to extend analyses of research data generated by clinical trials, population research, and demonstration and education research studies.

DESIGN NARRATIVE:

The first study used HHANES I data and analysis of variance to determine the possible body composition differences between subgroups of gender and smoking categories. Caloric differences in dietary intake were analyzed in a second ANOVA design.

The second study used data from HHANES I and NHANES II to evaluate the independent and additive or synergistic contribution of smoking rate and fasting glucose on body weight.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Klesges RC, Klesges LM, Meyers AW. Relationship of smoking status, energy balance, and body weight: analysis of the Second National Health and Nutrition Examination Survey. J Consult Clin Psychol. 1991 Dec;59(6):899-905. doi: 10.1037//0022-006x.59.6.899.
citation: Klesges RC, Ray JW, Klesges LM. Caffeinated coffee and tea intake and its relationship to cigarette smoking: an analysis of the Second National Health and Nutrition Examination Survey (NHANES II). J Subst Abuse. 1994;6(4):407-18. doi: 10.1016/s0899-3289(94)90334-4.
citation: Klesges RC, Klesges LM. The relationship between body mass and cigarette smoking using a biochemical index of smoking exposure. Int J Obes Relat Metab Disord. 1993 Oct;17(10):585-91.
citation: Klesges RC, Debon M, Ray JW. Are self-reports of smoking rate biased? Evidence from the Second National Health and Nutrition Examination Survey. J Clin Epidemiol. 1995 Oct;48(10):1225-33. doi: 10.1016/0895-4356(95)00020-5.
Clinical trial NCT04138472: Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy
Official title: Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Keywords: Dexmedetomidine
Fentanyl
Lignocaine
Laryngoscopy
Hemodynamic Response
Laparoscopic Cholecystectomy
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Dow University of Health Sciences
First posted: 2019-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: PREVENTION

Brief summary: Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Detailed description: Direct laryngoscopy and intubation are painful stimulus that activates sympathoadrenal discharge which results in intense cardiovascular reflex i.e. tachycardia and hypertension. In this study we will compare effects of intravenous dexmedetomidine, fentanyl and lidocaine for attenuation of these reflexes in patient undergoing laproscopic cholecystectomy. how these agents will effect hemodynamic response during pneumoperitoneum. Tertiary objective will be to observe sedation, perioperative complications and recovery in these patients.

Eligibility criteria: Inclusion Criteria:

* ASA-I and ll patients
* Male and female patient of age 20-70 years.
* Undergoing Elective surgery
* Intubation by skilled anesthetist of at least 2 years' experience
* Intubation not more than 45 seconds

Exclusion Criteria:

* Patients with uncontrolled DM, HTN, IHD, endocrine or autonomic dysfunction
* Pregnant and lactating females
* Short thick neck with anticipated difficult intubation
* Any sort of obstructive restrictive or reactive airway disease
* Patient allergic to any of the study medications.
* Obese patients, Narcotic addicts

Primary outcomes:
measure: systolic blood pressure
timeFrame: at induction
measure: Diastolic blood pressure
timeFrame: at induction
measure: mean atrial pressure
timeFrame: at induction
measure: Heart rate
timeFrame: at induction
measure: Oxygen saturation (SpO2)
timeFrame: at induction
Secondary outcomes:
measure: Sedation assessment
timeFrame: at 10 minutes post operative
measure: Recovery assessment
timeFrame: at 10 minutes post operatively
measure: Complications
timeFrame: 1 week Post-operative(Operation -discharge)
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: DUHS, Civil hospital Karachi (CHK)
state: Sindh
city: Karachi
country: Pakistan
facility: DUHS, Civil hospital Karachi (CHK)
state: Sindh
Study officials:
References: