louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04409938: Progressive Muscle Relaxation and Nature Sounds in Nursing Students
Official title: The Effect of Progressive Muscle Relaxation and Nature Sounds on Blood Pressure Measurement Skills, Anxiety Levels, and Vital Signs in Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Skill training
Nursing students
Anxiety
Blood Pressure Measurement Skills
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: The aim of this study was to determine the effect of PMR and nature sounds on nursing students' BPM skills, and anxiety levels and vital signs.

Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR+NS participants practiced PMR accompanied by nature sounds.

Detailed description: Background: The aim of this study was to determine the effect of PMR and nature sounds on nursing students' BPM skills, and anxiety levels and vital signs.

Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises. PMR+NS participants practiced PMR accompanied by nature sounds.

Eligibility criteria: Inclusion Criteria:

1. being a first-year nursing student
2. voluntary
3. participating in the theoretical part of the "Pulse and Blood Pressure Measurement" course and in lab practice.

Exclusion Criteria:

* not participating in the theoretical part of the "Pulse and Blood Pressure Measurement" course and in lab practice.

Primary outcomes:
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: pre-intervention
Secondary outcomes:
measure: The State Anxiety Inventory (SAI)
timeFrame: through study completion for each group, an average of 4 hour
measure: The Blood Pressure Knowledge Test (BPKT)
timeFrame: through study completion for each group, an average of 4 hour
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Sevda Korkut, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03740438: Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course
Official title: Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Blood Loss
Surgery
Perioperative/Postoperative Complications
Keywords: Hemoglobin
Hemoglobin drop
Surgical Blood loss
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients electively scheduled for laparoscopic urologic and gynecologic surgery.

Brief summary: transfusion-related decisions in the perioperative setting are often complex due to acute variations in the hemoglobin levels, which typically experience a progressive decrease within days. This process, commonly referred to as "hemoglobin drop" or "hemoglobin drift", has been observed to be highly variable among patients and reliant on several variables, such as the volemic status, fluid balance and blood loss. Although it has been investigated and some predictors have been identified, postoperative hemoglobin drop remains unpredictable and is not fully clarified. In consequence, hemoglobin levels' variations are frequently misunderstood, hindering the decision to transfuse.


Eligibility criteria: Inclusion Criteria:

* Adult patients electively scheduled for laparoscopic urologic and gynecologic surgery.

Exclusion Criteria:

* Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
* Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
* Transfusion of red blood cells (RBCs) or use of blood recovery systems during the perioperative period.
* Significant postoperative bleeding (\> 50 ml in surgical drains, gross hematuria, or any other type of significant blood loss).
* Postoperative hemodynamic instability (defined as requirement of vasoactive drugs).
* Other major postoperative complications during the observable period.

Primary outcomes:
measure: Hemoglobin concentration
timeFrame: 2-5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References:
Clinical trial NCT06593938: A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
Official title: A Multicenter, Randomized, Open-label, Active-comparator Controlled Phase III Study to Evaluate the Efficacy and Safety of HRS-5965 Capsule in Patients With Paroxysmal Nocturnal Hemoglobinuria
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Lead sponsor: Chengdu Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of PNH confirmed by flow cytometry with clone size \> 10%.
2. Have not received complement inhibitor therapy;
3. LDH \> 1.5\*ULN at screening.
4. Hemoglobin level \< 10 g/dL at screening.

Exclusion Criteria:

1. Known or suspected hereditary or acquired complement deficiency;
2. Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L);
3. Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;
4. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
5. Positive of HIV, HBsAg or HCVAb.

Primary outcomes:
measure: Proportion of subjects with the hemoglobin levels are ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of subjects with the change from baseline in hemoglobin is ≥ 2 g/dL at least on three out of four measurements in the absence of red blood cell transfusions
timeFrame: 24 weeks
measure: Proportion of subjects who absence of administration of red blood cell transfusions
timeFrame: 24 weeks
measure: Mean change from baseline in hemoglobin
timeFrame: 24 weeks
measure: Mean percent change from baseline in LDH levels
timeFrame: 24 weeks
measure: Mean change from baseline in reticulocyte counts
timeFrame: 24 weeks
measure: Mean change from baseline in FACIT-Fatigue scores
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Tianjin
country: China
facility: The Blood Disease Hospital of the Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
References:
Clinical trial NCT02155738: IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
Official title: The Impact of IV Acetaminophen on Postoperative Pain in Women Undergoing Pelvic Organ Prolapse Repair: A Double-Blind Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Keywords: IV acetaminophen
Postoperative pain
Pelvic organ prolapse surgery
Pelvic organ prolapse repair
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.

Detailed description: This randomized controlled trial of IV Acetaminophen compared to placebo will evaluate the effect of preoperative IV Acetaminophen on postoperative pain scores and narcotic requirements in women undergoing surgical repair of pelvic organ prolapse. 204 women will randomly receive 1000 mg of IV Acetaminophen or saline preoperatively within 30 minutes of surgical incision. Subjects will be offered narcotic and non-narcotic pain medications as needed during the postoperative period. Visual analogue pain scales (VAS) will be obtained at 4, 8, 12, 16, 20 and 24 hours postoperatively. Narcotic consumption will be recorded in morphine-equivalents. We hypothesize that women receiving IV Acetaminophen will have lower VAS scores and decreased narcotic requirements compared to controls.

Eligibility criteria: Inclusion Criteria:

* Women ≥ 18 years of age
* scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center
* women anticipated to have a hospital stay ≥24 hours

Exclusion Criteria:

* allergy/intolerance to acetaminophen
* hepatic dysfunction
* significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day

Primary outcomes:
measure: Change From Baseline in Postoperative Pain
timeFrame: 24 hours
measure: Cumulative Narcotic Consumption Over the First 24 Hours
timeFrame: First 24 hours
Secondary outcomes:
measure: Interference of Pain With Physical, Mental and Social Activities
timeFrame: 1 week
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of the University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
citation: Turner LC, Zyczynski HM, Shepherd JP. Intravenous Acetaminophen Before Pelvic Organ Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):492-502. doi: 10.1097/AOG.0000000000003102.
Clinical trial NCT02131038: Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray in Patients With Allergic Rhinitis
Official title: Non Interventional, Open Label Trial of Ectoine Containing Nasal Spray in Comparison With Cromoglycic Acid Containing Nasal Spray in Patients With Allergic Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Keywords: Ectoine
bitop
Allergic Rhinitis
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray. In addition the effectiveness and safety shall be compared to a Cromoglycid acid containing nasal spray. The patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and by the patient in a dairy at defined time intervalls.


Eligibility criteria: Inclusion Criteria:

* Female or male individuals ≥ 18 years
* Patients with proven Allergic Rhinitis which are treated with Ectoin Nasal Spray or -Cromoglycic acid nasal Spray during the observational period

Exclusion Criteria:

* Contra indications according to the label

Primary outcomes:
measure: Change in combined nasal symptom Score
timeFrame: Time Frame: day 1, day 7, day 14
Secondary outcomes:
measure: Patient's and physician's judgment of efficacy
timeFrame: Day 7 and 14
measure: Eye itching score,
timeFrame: Day 1, 7, 14
measure: Epiphora score
timeFrame: Day1, Day 7 and Day 14
measure: Conjunctivitis score,
timeFrame: Day 1, Day 7 Day 10
measure: Palatal itching score
timeFrame: Day 1, Day 7, Day 14
measure: Nasal muscle hyperplasia score
timeFrame: Day 1, Day 7 and Day 14
Other outcomes:
Locations:
city: Elmshorn
country: Germany
facility: HNO Praxis Elmshorn
Study officials:
affiliation: HNO Praxis Elmshorn
name: Uwe Sonnemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03298438: Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurofibromatosis 1
Diagnoses Disease
Post Traumatic Stress Disorder
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients or parent of a children followed for a neurofibromatosis type 1 in de novo form

Brief summary: Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was retained according to NIH criteria, familial forms were excluded. The French version of the Impact of Event Scale-Revised was used for the diagnosis of PTSD.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or more, or parent of a children
* Patient with a neurofibromatosis type 1 or parent of a children with a neurofibromatosis 1 in de novo form
* Followed for a neurofibromatosis type 1 de novo at the dedicated consultation in the University Hospital of Brest, since april 2013
* Agree to participate

Exclusion Criteria:

* Patients aged of 18 years old or lower
* Refusal to participate

Primary outcomes:
measure: Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form
timeFrame: Day 1 after diagnosis of neurofibromatosis
Secondary outcomes:
measure: Study methods of annoucement and feeling of patients with a questionnaire
timeFrame: Day 1 after diagnosis of neurofibromatosis
measure: Genetical analyze
timeFrame: Day 1 after diagnosis of neurofibromatosis
measure: Psychological or psychiatrical impact
timeFrame: Day 1 after diagnosis of neurofibromatosis
measure: Information about NF1
timeFrame: Day 1 after diagnosis of neurofibromatosis
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT01505738: Bacterial Growth in Vascular Surgery Wounds
Official title: The Effect of Bacterial Growth in Vascular Surgery Wounds to the Incidence of Postoperative Wound Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb Ischaemia
Aneurysm
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients requiring lower limb vascular surgery due to ischaemic changes and/or lower limb aneurysms.

Brief summary: The amount and species of bacteria have been shown to have an effect in wound infections in several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery of facial area). In vascular surgery, wound infections are a common and expensive complication. The aim of the present study is to investigate the prevalence of bacteria in vascular surgery wounds perioperatively, and determine whether is correlates with the incidence of wound infections postoperatively.


Eligibility criteria: Inclusion Criteria:

* need for lower limb vascular by-pass surgery

Exclusion Criteria:

* allergic to cefuroxime
* patients refusal to participate

Primary outcomes:
measure: wound infection
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Karelia Central Hospital, Clinic of Surgery
Study officials:
References:
Clinical trial NCT03392038: Thick vs. Thin Acellular Dermal Matrix (ADM)
Official title: Root Coverage Using the Coronally Positioned Tunnel Technique Comparing Thick Versus Thin Acellular Dermal Matrix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique.


Eligibility criteria: Inclusion Criteria:

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be ≥ 18 years of age.

Exclusion Criteria:

A. Patients with debilitating systemic or diseases that significantly affect the periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis. D. Root surface restorations at the site of recession. E. No detectable CEJ F. Patients who fail to maintain acceptable oral hygiene levels at the test and adjacent teeth.

G. Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. History of previous root coverage procedures, graft or GTR, on the test teeth.

L. Patients who fail to complete the informed consent form.

Primary outcomes:
measure: Percent root coverage
timeFrame: Six months
Secondary outcomes:
measure: Creeping Attachment
timeFrame: Six months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics, UofL School of Dentistry
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00846638: Women's Health Habits Study
Official title: Screening and Brief Intervention for Problem Drinking Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility
Keywords: Risk drinking
Women
Medical problems
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Office of Research on Women's Health (ORWH)
First posted: 2009-02-19
Enrollment: 611
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this randomized trial is to test the effectiveness of screening and brief intervention for risk drinking by nonpregnant women with specific medical problems exacerbated by excessive alcohol consumption. The medical problems are female factor infertility, hypertension, diabetes, and osteoporosis, conditions that are costly to treat and difficult to manage. Just as pregnant women are thought to be highly motivated to modify their alcohol consumption, so women with specific medical problems worsened by alcohol intake are an appropriate group to receive a brief intervention.


Eligibility criteria: Inclusion Criteria:

- 1. has diabetes, hypertension, osteoporosis, or infertility 2. Not currently receiving treatment for alcohol or drug problems or substance related medical illness 3. Not currently experiencing physical dependence on alcohol, requiring medically supervised detoxification 4. Not currently abusing or physically dependent on opiates, cocaine, or other illicit drugs 5. Not currently pregnant. Subjects with infertility may become pregnant during the course of the study.

6. Not currently nursing. 7. Able to complete study measures.

Exclusion Criteria:

1. Alcohol screen negative or drinks within NIAAA sensible drinking limits for women
2. Does not agree to randomization and study terms

Primary outcomes:
measure: Drinking outcome
timeFrame: 12 months post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01395238: Enhancing Father's Ability to Support Their Preschool Child
Official title: Enhancing Father's Ability to Support Their Preschool Child
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fathers
Parenting
High-risk
Child Maltreatment
Prevention
Keywords: fathers
parenting
high-risk
child maltreatment
prevention
Lead sponsor: Queens College, The City University of New York
Sponsor class: OTHER
Collaborators: name: State University of New York at Buffalo
First posted: 2011-07-15
Enrollment: 125
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study focuses on the development of the Fathers Supporting Success in Preschoolers (FSSP) Program, which combines evidence-based parenting interventions with Dialogic Reading to engage fathers in and improve parenting and child behavior.


Eligibility criteria: Inclusion Criteria:

* Male Guardian
* Child enrolled in partnering Head Start site

Exclusion Criteria:

* Mental Health issues that prohibit involvement in group-based prevention study (e.g., psychosis)

Primary outcomes:
measure: Parenting Behavior Checklist
timeFrame: post treatment (8 weeks after start of treatment )
measure: Eyberg Child Behavior Inventory
timeFrame: post treatment (8 weeks after start of treatment )
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale
timeFrame: post treatment (8 weeks after start of treatment )
measure: Parent Cognition Scale
timeFrame: post treatment (8 weeks after start of treatment )
measure: Preschool Language Scales
timeFrame: post treatment (8 weeks after start of treatment )
measure: Developing Skills Checklist
timeFrame: post treatment (8 weeks after start of treatment )
Other outcomes:
Locations:
city: Flushing
country: United States
facility: Queens College
state: New York
Study officials:
affiliation: Queens College, CUNY
name: Anil Chacko, PhD
role: PRINCIPAL_INVESTIGATOR
References: