louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06335823: Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
Official title: Randomized, Placebo-Controlled Study on the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD Insertion Pain
Keywords: contraception
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.


Eligibility criteria: Inclusion Criteria:

* Age 18-45 years old
* Individuals with a cervix and uterus
* Seeking intrauterine device (IUD) placement for contraception or management of abnormal uterine bleeding
* Meet medical eligibility for IUD placement
* Ability to consent in English
* Ability to use the visual analogue scale (VAS)

Exclusion Criteria:

* Contraindications to IUD placement
* Use of analgesics within the last 4 hours prior to IUD placement
* Presence of a pacemaker

Primary outcomes:
measure: Pain during IUD insertion as measured by the VAS score
timeFrame: IUD placement/introducer removal up to 5 minute
Secondary outcomes:
measure: Pain during IUD insertion as measured by the VAS score
timeFrame: speculum placement up to 1 minute
measure: Pain during IUD insertion as measured by the VAS score
timeFrame: tenaculum placement up to 1 minute
measure: Pain during IUD insertion as measured by the VAS score
timeFrame: sound insertion up to 5 minute
measure: Pain during IUD insertion as measured by the VAS score
timeFrame: 5 minute post IUD insertion
Other outcomes:
measure: Pain during IUD insertion as measured by the VAS score
timeFrame: baseline
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals
name: Jean M Marino, APRN-CNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01456923: Chemotherapy With DNA Damaging Agents In Colorectal Cancer
Official title: Phase 1 Study Of The Efficacy Of Chemotherapy With DNA Damaging Agents Versus Surgery In Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Keywords: DNA damaging agents
Lead sponsor: Centro Hospitalar Nordeste
Sponsor class: OTHER
First posted: 2011-10-21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy combined with surgery in colorectal cancer (CRC) avoiding surgery complications.


Eligibility criteria: Inclusion Criteria:

- patients that did not underwent surgery

Exclusion Criteria:

- patients that underwent surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01579123: Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia
Official title: Prospective Trial Comparing Laser Atherectomy to Angioplasty With/Without Stenting for Infrageniculate Peripheral Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Keywords: Laser atherectomy
Critical Limb Ischemia
Angioplasty
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 200
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: The reason the investigators are doing this study is to compare the results of laser atherectomy versus angioplasty with or without the placement of a stent in the artery. A stent is a metal tube used to open up narrow arteries in the body.

Detailed description: People with peripheral artery disease that has severely reduced blood flow in their lower leg are usually treated with surgical bypass. This condition is known as Critical Limb Ischemia or CLI. Over the last decade, advances in techniques and tools have allowed surgeons to more aggressively treat complex cases. Studies have shown successful treatment of CLI with endovascular techniques (less invasive surgical procedures through a small incision for the treatment of vascular disease), including laser atherectomy and angioplasty. Surgical guidelines are not clear as to the best procedure to use for CLI. To the best of our knowledge, a study comparing laser atherectomy and angioplasty has not been done. Laser atherectomy works by releasing ultraviolet light which is absorbed by the plaque in the arteries. This will then get rid of the plaque. Angioplasty is a procedure used to open blocked or narrowed arteries. Currently, it is not known if laser atherectomy has better results than angioplasty.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Male or female (non-pregnant females)
* Patients with peripheral artery disease that has progressed to critical limb ischemia (CLI)
* Patients undergoing angiography with possible intervention for Rutherford Class 4-6 limb ischemia that may benefit from revascularization

Primary outcomes:
measure: Outcome measure: difference in patency rates
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Regional Medical Center at Plano
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
Study officials:
affiliation: Baylor Jack and Jane Hamilton Heart Hospital
name: William Shutze, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04875923: Cardiac Surgery as a Means of Reversing Frailty
Official title: Cardiac Surgery as a Means of Reversing Frailty - The CURE-Frailty Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Keywords: Frailty
Cardiac Surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing an elective cardiac surgical intervention

Brief summary: Frailty is a multifactorial condition associated with older age, which leads to increased vulnerability to external stressors, such as infections or surgical procedures. Key features of frailty are unintentional weight loss, reduced strength and physical activity as well as the feeling of exhaustion.

When selecting patients for surgery, frailty can play an important part in resource planning and prognostication. Multiple studies have shown frailty to have a negative impact on mortality, perioperative adverse events, hospital length of stay as well as postoperative quality of life and functional status. Despite it being an important patient-centered outcome, postoperative quality of life tends to be overlooked when selecting patients for surgery.

Cardiac surgery presents a massive stressor to the frail patient, but on the other hand might have the ability to reduce disease burden and improve functional status, thus reducing frailty.

This prospective observational cohort study aims to assess frailty, as well as functional status and quality of life in cardiosurgical patients pre- and postoperatively, and evaluate its impact on postoperative clinical and functional outcomes.

The primary endpoint of this study is the change in postoperative level of frailty.


Eligibility criteria: Inclusion Criteria:

* age ≥ 60 years
* elective cardiac surgery

Exclusion Criteria:

* age \< 60 years
* emergency procedures
* pulmonary thromboendarterectomy
* declined informed consent
* pregnant women

Primary outcomes:
measure: Change in Postoperative Level of Frailty
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life assessed by the "SF-12 Patient Questionnaire"
timeFrame: 12 months
measure: Functional Status assessed by the "Functional Independence Measure"
timeFrame: 12 months
measure: 30-day Mortality
timeFrame: 30 days
measure: Overall Mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Martin Bernardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00771823: Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers
Official title: A Placebo Controlled Study of the Impact on Insulin Sensitivity and Lipid Profile of Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Lead sponsor: St Stephens Aids Trust
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A placebo controlled study of the impact on insulin sensitivity and lipid profile of maraviroc 300 mg twice daily in HIV negative male volunteers.


Eligibility criteria: Inclusion Criteria:

* Subjects must have documented negative HIV serology by ELISA and P24 antigen
* Subjects must be clinically well males aged between 18 to 60 years.
* Fasting blood glucose, total cholesterol and triglycerides within normal limits
* Hepatic transaminases (AST and ALT) ≤ 3 × upper limit of normal (ULN)
* Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.0 g/dL)
* Serum amylase ≤ 1.5 × ULN
* Sexually active males must use condoms during the course of the study
* Life expectancy ≥ 1 year
* Willing and able to provide informed consent

Exclusion Criteria:

* Subjects with a waist hip ratio \> 0.97 or BMI \> 28 kg/m2 will be excluded
* Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
* Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
* Other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension.
* Receiving on-going therapy with any of the following:

  * Metabolically active medications
  * Any lipid-lowering medication
  * Hormonal agents (oestrogens or androgens)
  * Glucocorticoids
  * Beta-blockers
  * Thiazide diuretics
  * Thyroid preparations
  * Psychotropic agents
  * Anabolic steroids
  * Megestrol acetate

Primary outcomes:
measure: Change from baseline in insulin sensitivity by euglycaemic clamp method
timeFrame: two weeks
Secondary outcomes:
measure: Change from baseline in serum levels of fasting cholesterol, triglycerides Changes in serum biomarkers of vascular inflammation and in CD36 PMBC and other related markers gene expression
timeFrame: two weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: St Stephen's AIDS Trust
name: Graeme Moyle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03858023: Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
Official title: Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prader-Willi Syndrome
Keywords: hippotherapy
gross motor
balance
behavior
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2019-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 42
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the therapeutic effects of hippotherapy in children with Prader-Willi syndrome. Half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy.

Detailed description: This study evaluates the therapeutic effects of hippotherapy in children with Prader-Willi syndrome. Half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy.

The primary purpose of this study is to investigate effect of hippotherapy on motor function of Prader-Willi syndrome patients.

The secondary purpose is to compare motor function, obesity, and behavior of the children after the intervention with those parameters before the intervention.

Eligibility criteria: Inclusion Criteria:

* can sit upright on the static surface
* can follow one step command

Exclusion Criteria:

* body wight \> 35 kg
* serious medical conditions such as cardiac disease, pulmonary disease, uncontrolled epilepsy
* visual impairment, hearing impairment
* bleeding tendency, anticoagulation
* fracture within 6 months, major orthopedic surgery within 1 year

Primary outcomes:
measure: Clinical global Impression-Severity of illness (CGI-S) score
timeFrame: 15 weeks
measure: Clinical global Impression-Improvement (CGI-I) score
timeFrame: 15 weeks
Secondary outcomes:
measure: Gross motor function assessed by GMFM-88 (Gross Motor Function Measure) score
timeFrame: 15 weeks
measure: Pediatric Balance Scale
timeFrame: 15 weeks
measure: PWS (Prader-Willi syndrome) hyperphagia questionnaire
timeFrame: 15 weeks
measure: Child Behavior Checklist (CBCL)
timeFrame: 15 weeks
measure: Obesity measured by DEXA (Dual-energy X-ray Absorptiometry)
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: JEONG-YI KWON, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04446923: Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing
Official title: Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Diseases
Surgical Site Infection
Keywords: hand antisepsis
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover design is used
Primary purpose: TREATMENT

Brief summary: The present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method in order to test if pass the standard european norm 12791.

Detailed description: The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by rub and scrub. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Eligibility criteria: Inclusion Criteria:

* Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
* They do not use substances with antibacterial action.

Exclusion Criteria:

* Taken antibiotics before 10 days of the intervention.
* Wear any jewellery on the hands.

Primary outcomes:
measure: Reduction of bacterial load immediately after hand scrub
timeFrame: Change from bacterial load at 5 minutes.
Secondary outcomes:
measure: Reduction of bacterial load after 3 hours of hand scrub
timeFrame: Change from bacterial load at 3 hours.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ricardo Becerro de Bengoa Vallejo
Study officials:
affiliation: Ricardo becerro de Bengoa Vallejo
name: Ricardo Becerro de Bengoa Vallejo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03856723: Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of RRT
Official title: Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of REnal Replacement Therapy (POCKET)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
Renal Replacement Treatment
Biomarker
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%. CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality.

Brief summary: The aim of this study was to verify the prognostic value of functional kidney biomarkers on survival and renal function recovery in cardiac surgery patients with acute kidney injury.

Detailed description: Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. Few biomarkers were validated as outcome-specific biomarkers in patients developing AKI after cardiac surgery at initiation of RRT. This study was designed to not only verify the prognostic value of functional kidney biomarkers on survival, but also predict it severity in order to optimize clinical decision making with respect to dialysis initiation and discontinuation.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery who required renal replacement therapy.

Exclusion Criteria:

* History of End Stage Renal Disease or on Dialysis
* prior kidney transplantation
* patients with a DNR order or "do not escalate care" order

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
measure: Dependence on renal-replacement therapy at 28 days in survivors
timeFrame: 28 days
Secondary outcomes:
measure: 60- and 90-day mortality
timeFrame: Up to 60 or 90 days
measure: Length of stay in the ICU
timeFrame: Up to 90 days or ICU discharge
measure: Length of stay in the hospital
timeFrame: Up to 90 days or hospital discharge
measure: Adverse events
timeFrame: Up to 90 days
measure: the number of days free of renal-replacement therapy, mechanical ventilation at 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
Study officials:
affiliation: Fudan University
name: Zhe Luo, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01246323: Combined Anesthesia for Laparoscopy Surgery in Gynecology
Official title: Combined General and Spinal Anesthesia vs. General Anesthesia for Pain Relief During Laparoscopy Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Visual analogue scale
pain level
analgesia
combined anesthesia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
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 combined anesthesia will provide better pain control for the postoperative period following gynecological laparoscopy surgery.

Detailed description: Following signing an informed consent patients who are scheduled for gynecological laparoscopy surgery for benign disease will randomized to general vs. combined general and spinal anesthesia.

During the postoperative period data regarding pain level as evaluated by visual analogue scale (VAS), number of doses of pain relief drugs, satisfaction and number of day in hospitalization will be collected from patient charts.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiology (ASA) physical status classification system:ASA I-III.
2. Benign Gynecological Laparoscopy surgery

Exclusion Criteria:

1. Patients who are not capable to sign the consent form.
2. Women with known allergy to the medication used in spinal analgesia.
3. Patients who are pregnant or lactating.
4. Patients with contraindication to spinal analgesia.
5. Patients who use opioid on a regular base.

Primary outcomes:
measure: Pain level
timeFrame: For the first 72 hours following surgery
measure: Number of doses of analgesic drugs
timeFrame: For the first 72 hours following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Lior Lowenstein
role: STUDY_CHAIR
References:
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citation: Motamed C, Bouaziz H, Franco D, Benhamou D. Analgesic effect of low-dose intrathecal morphine and bupivacaine in laparoscopic cholecystectomy. Anaesthesia. 2000 Feb;55(2):118-24. doi: 10.1046/j.1365-2044.2000.055002118.x.
citation: Kong SK, Onsiong SM, Chiu WK, Li MK. Use of intrathecal morphine for postoperative pain relief after elective laparoscopic colorectal surgery. Anaesthesia. 2002 Dec;57(12):1168-73. doi: 10.1046/j.1365-2044.2002.02873.x.
citation: Karaman S, Kocabas S, Uyar M, Zincircioglu C, Firat V. Intrathecal morphine: effects on perioperative hemodynamics, postoperative analgesia, and stress response for total abdominal hysterectomy. Adv Ther. 2006 Mar-Apr;23(2):295-306. doi: 10.1007/BF02850135.