louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05072873: Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy
Official title: The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy Undergoing Cesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a double-blind randomized controlled study
Primary purpose: PREVENTION

Brief summary: twin pregnant women requesting cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.

Detailed description: The most common cause of postpartum hemorrhage (PPH) is uterine atony, which accounts for up to 80% of PPH occurrences. PPH is the main cause of maternal morbidity and mortality, accounting for up to 28% of all maternal deaths globally. As a result, generating a fast and efficient uterine contraction after birth is critical. Obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis, as well as a twin pregnancy, are all risk factors for uterine atony.

Eligibility criteria: Inclusion Criteria:

* Women With Twin Pregnancy Undergoing Cesarean Section

Exclusion Criteria:

* Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
* patients with a high possibility of the morbid adherent placenta,
* known coagulopathy and
* those presented with severe antepartum hemorrhage
* refuse to participate

Primary outcomes:
measure: intraoperative blood loss
timeFrame: 30 minutes
Secondary outcomes:
measure: postoperative blood loss
timeFrame: 12 hours
measure: need of blood transfusion
timeFrame: 24 hours
measure: need of uterotonic
timeFrame: 24 hours
measure: change in hemoglobin
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02415231: "The Effect of Humor and Laughter on C Reactive Protein: A Pilot Study"
Official title: "The Effect of Humor and Laughter on C Reactive Protein: A Pilot Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: humor laughter C reactive protein
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study is to see if watching humor and laughing can affect CRP levels in healthy individuals. This is a randomized controlled trial.

Detailed description: Subjects will be...males and females: students, employees, and members of the community.

5. "Subjects will be between ___18_ and ___99_ years of age."

6. "In total, subject participation will last approximately ___1 day for 90 minutes_

7. "Subjects will be recruited _by word of mouth at the Loma Linda University Campus and surrounding communities___."

8. "Consent will take place _by investigators in Nichol Hall Room A620/A640___."

9. If Multi-center:

10. If Single center or investigator-initiated:

"_60__ subjects will participate in the study."

Eligibility criteria: Inclusion Criteria:

* Ages 18-99 yrs , healthy individuals

Exclusion Criteria:

* Under 18 years old, or over 99 years old, non healthy individuals

Primary outcomes:
measure: CRP level
timeFrame: change in CRP levels over 3 time frames (baseine, immediately after intervention, and 30 minutes later)
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Nichol Hall Room A640
state: California
Study officials:
affiliation: Loma Linda University
name: gurinder bains, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06518031: The Effects of Meditation on Stress and Fatigue
Official title: The Effects of Meditation on Stress and Fatigue in Intensive Care Nurses: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Nurses
Keywords: Meditation
Stress
Fatigue
Intensive Care Nurses
Well-being
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized controlled trial was conducted with nurses practicing meditation for six weeks, compared to a control group with no intervention. Stress and fatigue levels were measured using validated scales at baseline and post-intervention.

Detailed description: Participants in the intervention group underwent a meditation practice for 20 minutes, three times a week for six weeks. The meditation sessions were led by a meditation expert with 8 years of experience and conducted online via WhatsApp in a group setting. No intervention was given to the participants in the control group.

Eligibility criteria: Inclusion Criteria:

* Intensive care nurses with at least 1 year of experience in the intensive care unit.
* Nurses without chronic obstructive pulmonary disease, heart failure, asthma, or other conditions that could hinder breathing exercises.
* Nurses without hearing and communication issues, psychiatric diagnoses (e.g., major depression).
* Nurses who have not attended meditation, yoga, or breathing exercise classes in the past six months.
* Nurses willing to participate in the study were included in the sample.

Exclusion Criteria:

* Nurses who do not attend at least one of the meditation sessions conducted by the meditation expert.

Primary outcomes:
measure: STRESS LEVELS
timeFrame: after 6 weeks
measure: FATIGUE LEVELS
timeFrame: after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Songül GÜNGÖR
state: Osmani̇ye
Study officials:
References:
Clinical trial NCT04503031: Comparison of Nasal Taper-guard Cuffed and a Nasal Cylindrical Endotracheal Tube
Official title: Comparison of the Endotracheal Tube Cuff Pressure Between a Taper-guard Cuffed Nasal Endotracheal Tube and a Cylindrical-shaped Cuffed Nasal Endotracheal Tube After Changing in Position of Head
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Tube
Cuff Pressure
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during oral surgery.

Detailed description: The patient in cylindrical group (n=26) were intubated with cylindrical shaped endotracheal tube (Unomedical, Kedah, Malaysia) and the patient in tapergaurd group (n=26) was intubated with TaperGuard endotracheal tube (Covidien, Athlone, Ireland). The group allocations were informed to the attending anesthesiologist prior to anesthesia. Tracheal intubation was performed with size of inner diameter 7.0 mm endotracheal tube for male and 6.5 mm endotracheal tube for female by the same anesthesiologist. The anesthesiologist measured cuff pressure and distance from endotracheal tube tip to carina during study period.This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube, compared to cylindrical endotracheal tube during oral surgery.

Eligibility criteria: Inclusion Criteria:

* Patient who were underwent nasal intubation

Exclusion Criteria:

* history of difficult intubation, limited neck movement, respiratory diseases and body mass index more than 35 kg/m2

Primary outcomes:
measure: Cuff pressure
timeFrame: 5 minutes after change of head position
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: kyungook national university hospital
name: Younghoon Jeon, Mr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06828731: Evaluation of Empagliflozin vs Standard Care in Veterans With Prediabetes
Official title: Sodium-glucose Transporter 2 Inhibitor Use in Pre-diabetes: Initial Evaluation in Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prediabetes
Lead sponsor: Charles George VA Medical Center
Sponsor class: FED
First posted: 2025-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prediabetes effects 96 million people 18 years of age or older. It is important to identify treatment options to slow or prevent progression to diabetes. It is also critical to assess the potential of medications like sodium glucose transporter 2 inhibitors to reduce the risk of cardiovascular events and kidney complications, both common and costly complications of diabetes. This is a 12-week, open-label pilot feasibility study assessing the use of empagliflozin in prediabetes.


Eligibility criteria: Inclusion Criteria:

Diagnosis of prediabetes defined by HbA1c \>5.7% and \<6.5% or fasting glucose 100-125 mg/dL with documentation of diagnosis (ICD-10 code) within electronic health record at time of enrollment

* Age 35 to 60 years at time of enrollment
* Able to read and speak English

Exclusion Criteria:

* Diagnosis of diabetes (type 2 or type 1)
* Contraindication to SGLT2i medication per medication labeling, prior adverse reaction to SGLT2i medication, or received SGLT2i medication within the 6 months prior to enrollment
* Currently prescribed an antihyperglycemic agent approved for treatment of type 2 diabetes or taking any FDA-approved weight loss agent or over-the-counter supplement promoted for weight loss
* Veterans unable to complete informed consent process (Veterans with impaired decision-making ability or who require use of a legally authorized representative)
* Women who are pregnant or may become pregnant
* Veterans with neurogenic bladder, indwelling catheter, or urinary tract infection within the previous 12 months requiring hospitalization or emergency department visit

Primary outcomes:
measure: Recruitment
timeFrame: 12 weeks
measure: Retention
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: Renal function
timeFrame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
measure: Weight
timeFrame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
measure: Blood pressure
timeFrame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
measure: Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Charles George VA Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT00621231: The Protein (Meat) and Function Study
Official title: Effect of Normal Versus High Amounts of Protein Intake on Physiological Functions and Proteomics in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Protein Function
normal versus high protein intake
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2008-02-22
Sex: MALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the proposed study is to investigate the effects of different amounts of protein intake primarily from meat on muscle function, immune response, mental function, proteomics, biochemical regulators of protein metabolism, energy expenditure, and composition in young healthy males.


Eligibility criteria: Inclusion Criteria:

* Healthy males, 19-40 y/o

Exclusion Criteria:

* Smokers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of human nutrition
state: DK-Frederiksberg C
Study officials:
References:
citation: Jakobsen LH, Kondrup J, Zellner M, Tetens I, Roth E. Effect of a high protein meat diet on muscle and cognitive functions: a randomised controlled dietary intervention trial in healthy men. Clin Nutr. 2011 Jun;30(3):303-11. doi: 10.1016/j.clnu.2010.12.010. Epub 2011 Jan 15.
Clinical trial NCT05597631: G-IVF and Sperm Parameters
Official title: Does Adding Medium to Fresh Semen Samples Increase Motility After Preparation?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility, Male
Keywords: Sperm motility
Sperm preparation
Osmolarity
Lead sponsor: Vitrolife
Sponsor class: INDUSTRY
First posted: 2022-10-28
Enrollment: 118
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate if adding a fixed volume of a physiological solution to a freshly produced sperm sample will affect sperm characteristics.


Eligibility criteria: Inclusion Criteria:

* Patients producing a pre-clinical semen sample at the clinic

Exclusion Criteria:

* Patients with known azoospermia
* Patients who have had a vasectomy

Primary outcomes:
measure: Proportion of progressive motile sperm (%)
timeFrame: 10 minutes of assessment will be used to count the motile sperm for each sample.
Secondary outcomes:
measure: Sperm yield (%)
timeFrame: 10 minutes used to assess motilty (as for primary outcome)
Other outcomes:
Locations:
city: Maroussi
country: Greece
facility: IASO Maternity and Gynecology Clinic
Study officials:
References:
Clinical trial NCT06948331: RADA16 for Aquablation Day Case
Official title: A Pilot Proof of Concept Single-arm Study Using PuraStat Following the Aquablation Procedure to Assess Reduction of Hematuria to Allow for Same Day Discharge
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hematuria
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 25
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot proof of concept single-arm study using PuraStat following Aquablation procedure to assess reduction of hematuria to allow for same day discharge.

The primary objective is to assess how PuraStat affects post-operative hematuria following Aquablation.

The secondary objective is to assess the number of patients discharged on the same day based on the hematuria criteria (Grade 0 and Grade I).


Eligibility criteria: Inclusion Criteria:

• Any man undergoing Aquablation for LUTS due to BPH

Exclusion Criteria:

• Unwilling to sign consent

Primary outcomes:
measure: Percentage of Patients Discharged the Same Day as Aquablation
timeFrame: Day 1 (Operative Visit)
Secondary outcomes:
measure: Mean Post-Operation Hematuria Grade
timeFrame: Day 1 (Up to Hour 3 Post-Op)
measure: Percentage of Patients who Experience Dysuria during Follow-Up
timeFrame: Up to Week 4 Post-Operation
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Christopher Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04783831: Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy
Official title: Usefulness of Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy. Prospective Non-randomized Controlled Clinical Study Comparing Biodegradable vs Non-biodegradable Stents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Fistula
Pancreas Neoplasm
Stent Disintegration
Pancreatic Cancer
Pancreatic Anastomotic Leak
Keywords: pancreaticoduodenectomy
pancreaticojejunostomy
pancreatic stent
pancreatic fistula
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).

Brief summary: Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications.

Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum.

The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of \> 5000 U/L on the first day).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).

Exclusion Criteria:

* Patients with soft pancreas or chronic pancreatitis.

Primary outcomes:
measure: POPF
timeFrame: 1 week
Secondary outcomes:
measure: Position and degradation of biodegradable stents
timeFrame: 3 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: David Ferreras
Study officials:
References:
Clinical trial NCT02374931: 18F-FES PET/CT in Imaging Patients With Desmoid Tumors
Official title: Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Deep Fibromatosis/Desmoid Tumor
Familial Adenomatous Polyposis
Keywords: desmoid
FES-PET
aggressive fibromatosis
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-03-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies fluorine (F)-18 16 alpha-fluoroestradiol (18F-FES) positron emission tomography (PET)/computed tomography (CT) in imaging patients with desmoid tumors. 18F-FES binds to estrogen receptors, which are present on desmoid tumors, and gives off radiation that may be detected by PET and CT scans. The PET/CT scan forms an image that may show where tumor cells with estrogen receptors can be found in the body.

Detailed description: PRIMARY OBJECTIVES:

I. Establish the avidity of desmoid tumors on 18F-FES PET/CT imaging. II. Correlate 18F-FES PET avidity with degree of estrogen receptor (ER) expression by immunohistochemistry (IHC).

OUTLINE:

Patients undergo 18F-FES PET/CT imaging over 30 minutes.

After completion of study, patients are followed up for 30 days.

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven extra-abdominal desmoid tumors
* Not currently on estrogen medication for birth control, menopause, or other reason
* No anti-estrogen therapy for desmoid tumor within the past 6 months
* Both sporadic desmoid tumors and those associated with familial adenomatous polyposis (FAP) syndromes will be included

Exclusion Criteria:

* Pregnancy or nursing patients
* Patients who do not wish to participate

Primary outcomes:
measure: Standard uptake value (SUV) measured as percent injected dose per cc
timeFrame: Initial visit, average within 24 hours of imaging
Secondary outcomes:
measure: IHC staining intensity in tissue samples
timeFrame: Within 4 weeks of imaging done at initial visit, day 1
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Ashish Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05374031: Multiple Sclerosis Intimacy and Sexuality Questionnaire
Official title: The Multiple Sclerosis Intimacy and Sexuality Questionnaire-15 (MSISQ-15): Validation of the Turkish Version in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Sexual Dysfunction
Questionnaires
Keywords: Multiple sclerosis
questionnaires
sexual dysfunction
self-report
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 130
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multiple Sclerosis women

Brief summary: Aims: This study aimed to psychometrically evaluate the Turkish version of the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-15) in women with MS.

Methods: The study included 130 women with MS. The Turkish linguistic validation process of the original English MSISQ-15 was performed according to standardized guidelines. Reliability analysis was evaluated with test-retest analysis and intra-class correlation (ICC). Internal consistency between the items was analyzed using the Cronbach's alpha coefficient. Item analysis results were used to assess the contribution of the items to the scale. In evaluating the validity of the scale, the relationship between the MSISQ and the Female Sexual Function Index (FSFI), the Multiple Sclerosis Quality of Life Questionnaire-54 (MSQOL-54), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PSIQ-12) was investigated. Psychometric properties were analyzed using internal consistency, test-rest reliability, construct validity, and floor-ceiling effect.


Eligibility criteria: Inclusion Criteria:

* Women over the age of 18 who were literate,
* who did not have any mental problems preventing cooperation and understanding,
* who were diagnosed with MS

Exclusion Criteria:

* Having pelvic organ prolapse stage 2 or more;
* having a history of relapse in the past 30 days;
* experiencing loss of balance or gait disturbance caused by a condition other than MS;
* being pregnant; having a history of gynecological, urological and/or neurological surgery;
* having a history of cesarean or vaginal birth in the past six months;
* being sexually inactive; and, having urinary tract infections

Primary outcomes:
measure: Questionnaire
timeFrame: day 1
measure: Questionnaire
timeFrame: day 1
measure: Questionnaire
timeFrame: day 1
measure: Questionnaire
timeFrame: day 1
measure: Questionnaire
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Yozgat Bozok University
Study officials:
References: