louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07014111: Fight Fatigue: A Progressive Muscle Relaxation and Walking Intervention to Reduce Fatigue in Adults With ESKD
Official title: Fight Fatigue: A Progressive Muscle Relaxation and Walking Intervention to Reduce Fatigue in Adults With ESKD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: Fatigue
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Fight Fatigue is evaluating the feasibility and acceptability of a combined progressive muscle relaxation and walking intervention to reduce fatigue for adults with end-stage kidney disease receiving in-center hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ESKD diagnosis and receiving hemodialysis for at least 3 months
* Can read and speak English
* Fatigue measured via visual analogue scale, score ≥4 over the last week
* Able to stand and walk one block
* Has a cell phone that can receive text messages

Exclusion Criteria:

* Patient's nephrologist refuses for them to participate
* Unstable angina
* Unstable pulmonary disease or pulmonary symptoms that preclude participation
* Lower-extremity amputation without prosthetic (BKA, AKA) -Orthopedic or neurologic condition that would preclude walking or tensing/releasing of muscles-
* Cognitive impairment that, in the judgement of the research team, precludes trial participation
* Participation in the formative phase of the development of Fight Fatigue

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Baseline to week 12
measure: Feasibility of retention
timeFrame: Baseline to week 12
measure: Acceptability
timeFrame: End of study (Week 12)
measure: Adherence to the study protocol
timeFrame: Baseline to week 12
Secondary outcomes:
Other outcomes:
measure: Fatigue
timeFrame: Baseline to week 12
Locations:
Study officials:
References:
Clinical trial NCT05203211: Use of Testicular Spermatozoa in Non-azoospermic Patients
Official title: Use of Testicular Spermatozoa in Non-azoospermic Patients: Retrospective Analysis of a Single Center Experience.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Male Infertility
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All couples in a third-level University affiliated centre, between January 2010 and January 2020, whose male partner were diagnosed with any type of oligospermia and underwent TESE after ICSI from ejaculated semen, were included in the analysis.

Brief summary: Use of testicular spermatozoa in non-azoospermic patients.

Detailed description: The aim of the study is to evaluate the characteristics of couples whose male partner is offered TESE after the failure of previous ICSI technique performed with ejaculated semen. All couples in a third-level University affiliated centre, between January 2010 and January 2020, whose male partner were diagnosed with any type of oligospermia and underwent TESE after ICSI from ejaculated semen, were included in the analysis.

Eligibility criteria: Inclusion Criteria:

* All patients undergone testiscular sperm extraction (TESE) after failure of ICSI with the use of ejaculated sperm

Exclusion Criteria:

* Female age \>40 yo

Primary outcomes:
measure: fertilization rate (FR)
timeFrame: 10 years
Secondary outcomes:
measure: Blastulation rate (BR)
timeFrame: 10 years
measure: Miscarriage rate (MR)
timeFrame: 10 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
References:
citation: Ozmen B, Caglar GS, Koster F, Schopper B, Diedrich K, Al-Hasani S. Relationship between sperm DNA damage, induced acrosome reaction and viability in ICSI patients. Reprod Biomed Online. 2007 Aug;15(2):208-14. doi: 10.1016/s1472-6483(10)60710-9.
citation: Samplaski MK, Dimitromanolakis A, Lo KC, Grober ED, Mullen B, Garbens A, Jarvi KA. The relationship between sperm viability and DNA fragmentation rates. Reprod Biol Endocrinol. 2015 May 14;13:42. doi: 10.1186/s12958-015-0035-y.
citation: Kendall Rauchfuss LM, Kim T, Bleess JL, Ziegelmann MJ, Shenoy CC. Testicular sperm extraction vs. ejaculated sperm use for nonazoospermic male factor infertility. Fertil Steril. 2021 Oct;116(4):963-970. doi: 10.1016/j.fertnstert.2021.05.087. Epub 2021 Jul 4.
citation: Donoso P, Tournaye H, Devroey P. Which is the best sperm retrieval technique for non-obstructive azoospermia? A systematic review. Hum Reprod Update. 2007 Nov-Dec;13(6):539-49. doi: 10.1093/humupd/dmm029. Epub 2007 Sep 24.
citation: Kang YN, Hsiao YW, Chen CY, Wu CC. Testicular sperm is superior to ejaculated sperm for ICSI in cryptozoospermia: An update systematic review and meta-analysis. Sci Rep. 2018 May 18;8(1):7874. doi: 10.1038/s41598-018-26280-0.
Clinical trial NCT06937411: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DC-853 in Healthy Participants
Official title: A Phase I, Randomized, Double-Blinded, Placebo-Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Ascending Doses of DC-853 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-04-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy participants.

Participation could last up to 7 weeks


Eligibility criteria: Inclusion Criteria:

* Participants must be able to understand and comply with the requirements of the study, as judged by the Investigator.
* Participants must have a body mass index (BMI) ≥ 18 and ≤ 35 kilograms per meter squared (kg/m2).

Exclusion Criteria:

* History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical study or expose the participant to undue risk as judged by the Investigator.
* Malignancy within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma, resected benign colonic polyps, or adequately treated cervix carcinoma in-situ.
* Planned major surgery within duration of the study or the 30 days following study completion.
* Females who are pregnant, breast feeding, lactating or plan to be pregnant during the study period or 90 days after.
* History of any drug and/or alcohol abuse in the past 2 years prior to screening.

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 1
timeFrame: Baseline up to 6 Days
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 2
timeFrame: Baseline up to 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Medicines Evaluation Unit Ltd.
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 NCT04996511: Day Case Colectomy: Optimizing Short Stay-surgery.
Official title: Day Case Colectomy: Optimizing Short Stay-surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Monitoring, Physiologic
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2021-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.

Detailed description: Patients scheduled for colorectal surgery are recruited to the study. HRV parameters including e.g. RMSSD are evaluated before and after surgery. The effect of surgery and possible complications associated with it on parameters and relationship with specific adverse effects caused by complications are evaluated.

Eligibility criteria: Inclusion Criteria:

• Colorectal resection for any pathology

Exclusion Criteria:

• Arrhytmias likely to cause problems with HRV measurements

Primary outcomes:
measure: Heart Rate Variability (HRV) change
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
Study officials:
affiliation: Päijät Häme Central Hospital
name: Juha KA Rinne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rinne JKA, Miri S, Oksala N, Vehkaoja A, Kossi J. Evaluation of a wrist-worn photoplethysmography monitor for heart rate variability estimation in patients recovering from laparoscopic colon resection. J Clin Monit Comput. 2023 Feb;37(1):45-53. doi: 10.1007/s10877-022-00854-w. Epub 2022 Apr 8.
Clinical trial NCT04718311: Study on Treatment for Patients With Symptomatic Oral Lichen Planus
Official title: Analysis of Two Treatment Protocols for Patients With Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Planus, Oral
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to compare the therapeutic efficacy of Tacrolimus gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.

Detailed description: Thirty nine patients were assigned, through a randomized design, to receive tacrolimus ointment 0.1% or a mouthwash composed of calcium hydroxide 10%, hyaluronic acid 0,3%, umbelliferone and oligomeric proanthocyanidins, or an anti-inflammatory mouthwash (mouthwash which contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins) for 3-months. At baseline (T0) and after 3 months (T1), patients were subjected to clinical and oral assessments and were evaluated for the symptoms (Numerical Pain Scale, NRS score) and signs (Thongprasom's score) of OLP. Data were calculated using T-test for the dependent variable, Wilcoxon test and Mann-Witney u test.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years;
* clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria;
* presence of symptoms related to OLP.

Exclusion Criteria:

* presence of systemic conditions that may have affected the study results;
* state of pregnancy or breastfeeding;
* histological signs of dysplasia;
* drugs inducing a lichen response (ACE-inhibitors, β-blockers, etc.);
* treatment of OLP in the six months prior to the start of the programme;
* presence of extraoral lesions (genital, skin and other)
* history of previous immunodeficiency or HIV seropositivity;
* previous allogeneic bone marrow transplantation;
* presence of systemic lupus erythematosus or other autoimmune diseases.

Primary outcomes:
measure: Clinical Mucosal healing
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
state: CT
Study officials:
affiliation: Università degli Studi di Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06111911: Detection of High-Risk HPV in Urine and Cervical Swab Specimen Using HPV Diagnostic Kit (Bio Farma)
Official title: Detection of High-Risk Human Papilloma Virus in Urine and Cervical Swab Specimens; Comparison Between HPV Diagnostic Kit (Bio Farma) and COBAS 6800 HPV (Roche Molecular Systems)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus Infection
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 900
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a cross-sectional study to evaluate accuracy of high-risk DNA-HPV testing using HPV Diagnostic Kit (Bio Farma) compared to Standard Kit (COBAS® 6800 HPV from Roche Molecular Systems) RT-PCR based in urine and cervical swab specimens.


Eligibility criteria: Inclusion Criteria:

* Sexually active female aged 20-50 years
* Willing to participate in study and signed the informed consent form.

Exclusion Criteria:

* Pregnant women
* History of HIV infection
* On menstruation period
* History of complete HPV vaccination

Primary outcomes:
measure: Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample
timeFrame: 0 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT04271111: Computerized Intervention for Interpersonal Stress
Official title: Computerized Intervention for Interpersonal Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hostility
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into active treatment or control condition.
Primary purpose: TREATMENT

Brief summary: This study assesses whether a computerized intervention can be used to decrease perceived hostility in hostile individuals.

Detailed description: This study will investigate whether a brief computerized intervention can decrease perceived hostility of interpersonal situations. Participants will be randomized into an active treatment or control condition. We hypothesize that participants in the treatment condition will have lower perceived hostility at post treatment than those in the waitlist condition.

Eligibility criteria: Inclusion Criteria:

* Increased hostility based on the Buss Perry Aggression Questionnaire

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in Cook Medley Hostility Inventory
timeFrame: Baseline, one hour, one week, one month
measure: Changes in Word Sentence Association Paradigm-Hostility
timeFrame: Baseline, one hour, one week, one month
measure: Changes in Alcohol Use Disorders Identification Test
timeFrame: Baseline, one hour, one week, one month
measure: Changes in Drinking Motives Questionnaires
timeFrame: Baseline, one hour, one week, one month
measure: Changes in alcohol use
timeFrame: Baseline, one hour, one week, one month
Secondary outcomes:
measure: Changes in Self Stigma of Seeking Help
timeFrame: Baseline, one hour, one week, one month
measure: Changes in Perceived Stigma and Barriers to Care for Psychological Treatment
timeFrame: Baseline, one hour, one week, one month
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References:
Clinical trial NCT04575311: A Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.

Detailed description: The study will evaluate minimum of 2 dose levels of AB680 in 8 participants per cohort. Cohorts will be gender-balanced to the extent possible, and will be randomized 3:1, active vs placebo, respectively.

The participants will be closely observed for the first 48 hours following drug administration to monitor the general tolerability of AB680.

Eligibility criteria: Inclusion Criteria:

* Male or female participants aged 18 to 55 years, inclusive, at screening
* Body mass index 18 to 32 kilograms/m\^2 inclusive
* Willing and able to sign informed consent
* Negative tests for hepatitis B surface antigen, anti-hepatitis C virus, and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
* Healthy as determined by pre-study screening

Exclusion Criteria:

* History of clinically significant drug and/or food allergies
* Positive drug and alcohol screen at screening and (each) admission to the clinical research center.
* Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to (the first) drug administration in the current study
* Participants who have significant infection or known inflammatory process on screening or admission

Primary outcomes:
measure: AB680 Peak Plasma Concentration (Cmax)
timeFrame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
measure: AB680 Time of Peak Concentration (Tmax)
timeFrame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
measure: Area under the plasma concentration-time curve from time zero to t hours (AUC 0-t) of AB680
timeFrame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
Secondary outcomes:
measure: Number of participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: From First Dose Date to 15 Days After the Last Dose of AB680
Other outcomes:
measure: Pharmacodynamic (PD) Effects of AB680
timeFrame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680]
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
References:
Clinical trial NCT05502211: A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease
Official title: A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease and Left Ventricular Systolic Dysfunction :( A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Induction of General Anesthesia
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients with coronary artery disease (CAD) and left ventricular systolic dysfunction (LVSD) presenting for coronary artery bypass grafting (CABG) represent a high-risk group among the cardiac surgical population. Anesthetic management of these patients is challenging due to increased risk of perioperative hypotension and subsequently increased risk of postoperative morbidity and mortality. Post induction hypotension is a modifiable risk that can be largely prevented by adjusting the technique for anesthesia induction. There is no consensus on the use of certain anesthetic induction techniques for patients CAD and left ventricular dysfunction. Anesthesia induction techniques for cardiovascular surgery are usually based on considerations such as hemodynamic stability, effects on myocardial oxygen supply, and demand and minimizing intubation stress response.To the best of our knowledge, there is no previous data comparing the efficacy of adding lidocaine versus fentanyl to the induction of anesthesia with ketamine in patients with poor ventricular function.


Eligibility criteria: Inclusion Criteria:

* Participants will be patients with coronary artery disease and moderate to severe left ventricular dysfunction (ejection fraction \< 40%), ASA physical status II-IV that will be scheduled for elective CABG surgery.

Exclusion Criteria:

* Patients with associated valvular heart disease, persistent arrhythmias, congestive cardiac failure, on mechanical ventilation, intra-aortic balloon pump (IABP), emergency surgery, and those with known allergy to any of the study's drugs, severe systemic non-cardiac disease; will be excluded from the study

Primary outcomes:
measure: incidence of hypotension
timeFrame: 15 minutes post inductin
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy
city: Cairo
country: Egypt
facility: Kasr al ainy
Study officials:
affiliation: lecturer of anesthesia Kasr Al Ainy hospital
name: Ayman Abougabal, MD
role: STUDY_CHAIR
References: