louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03574298: Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction
Official title: Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Keywords: Radical prostatectomy
urinary incontinence
pelvic floor muscle
reaction time
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting for urodynamic assessment

Brief summary: This study evaluate the effect of radical prostatectomy on involuntary pelvic floor muscle contraction

Detailed description: Radical prostatectomy may cause stress urinary incontinence (SUI). That poses problem in terms of quality of life. There are many treatment options available for patients with SUI, but the exact mechanism is not known. We compared, in continent and incontinent men post-radical prostatectomy, the correlation between the temporal course of pelvic floor activation during cough.

Simultaneously, recordings of electromyographic activity of external anal sphincter (EAS EMG) and external intercostal muscle (EIC EMG) during coughing will be made with a pair of pre-gelled electrodes. Cough effort cause an involuntary pelvic contraction. Intercostals muscles recording was chosen because they are one of the muscular components of cough initiation with diaphragm muscle. 24h pad-weighing test is used to quantify urinary incontinence. We will measure the latency between the onset of the EIC EMG and the EAS EMG (RT3), during a cough effort. We will also measure the duration of the contraction, the maximum EAS EMG activity and the area under the curve.

Eligibility criteria: Inclusion Criteria:

* Follow in neuro-urology for lower urinary tract symptoms
* Radical Prostatectomy

Exclusion Criteria:

* Perineal Radiotherapy
* Surgery for stress urinary incontinence

Primary outcomes:
measure: Latency (time)
timeFrame: 1 day: During electromyographic recording
Secondary outcomes:
measure: Duration (time)
timeFrame: 1 day: During electromyographic recording
measure: Maximum
timeFrame: 1 day: During electromyographic recording
measure: Area under the curve
timeFrame: 1 day: During electromyographic recording
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Neuro-urology, Tenon hospital
Study officials:
affiliation: GREEN GRC-01, Neuro-urology, hôpital Tenon
name: Gérard Amarenco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05364398: Comparison of ACL Reconstruction With Stump Preservation and Stump Resection
Official title: Does Stump-Preserving Anterior Cruciate Ligament Reconstruction Provide Better Functional Outcomes? A Prospective Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Ligament Injury
Keywords: Anterior cruciate ligament reconstruction
tibial stump
stump preservation
knee proprioception.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the clinical outcome in patients who had ACL reconstruction with preservation of the remnant and compare it with patients in whom the stump was resected

Detailed description: 100 patients are subjected to ACL reconstruction. Half of them had ACL reconstruction with Stump preservation and the other half had ACL reconstruction with stump resection.

The clinical outcome in both groups is assessed and compared

Eligibility criteria: Inclusion Criteria:

* patients with torn ACL within 6 months

Exclusion Criteria:

* Old ACL injury Multi-ligamentous knee injuries Mal-alignments

Primary outcomes:
measure: Knee stability
timeFrame: after 2 years
measure: Knee proprioception
timeFrame: after 2 years
measure: Lysholm score
timeFrame: After 2 years
measure: Tegner activity score
timeFrame: after 2 years
measure: IKDC score
timeFrame: after 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy, Cairo University
Study officials:
References:
citation: El-Desouky MA, Ezzat M, Abdelrazek BH. Clinical outcomes in stump-preserving versus stump-sacrificing anterior cruciate ligament reconstruction; a randomized controlled study. BMC Musculoskelet Disord. 2022 Jul 23;23(1):703. doi: 10.1186/s12891-022-05665-3.
Clinical trial NCT04109898: Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults
Official title: Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Keywords: airway management
I-gel
anaesthesia
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 114
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients. The half of the patients will receive standard and other half will receive the modified jaw thrust insertion technique

Detailed description: The I-gel is used to provide the oxygenation and ventilation in anaesthetised patients. The inventor suggested insertion technique is called standard technique.

Standard I-gel insertion technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block site. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate. Then I-gel will be slide downwards and backwards along the hard palate with a continuous but gentle push until a definitive resistance is felt.

Modified jaw thrust technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate and it slides gently into the oropharynx. I-gel will be left in oral cavity and both hands will be used to thrust the jaw by lifting the angle of mandible with little fingers and other fingers to stabilize the jaw then both thumbs will used to apply the balance force towards the final I-gel placement position by looking at the integral bite block mark at incisor teeth level.

Eligibility criteria: Inclusion Criteria:

* ASA I and II patients.
* Age 16 years to 60 years.
* Patient scheduled for elective surgical procedure.

Exclusion Criteria:

* Gastroesophageal reflux disorders
* Obesity BMI more than 30.
* Pregnancy
* Reactive airway disease/asthma
* Patients with mallampati score III \& IV
* Anticipated difficult airway
* Emergent surgery.
* Known allergic to isoflurane and propofol.

Primary outcomes:
measure: adverse airway events
timeFrame: 5 minutes
Secondary outcomes:
measure: adverse airway events
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: dileep kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02048098: Misoprostol for Second Trimester Termination of Pregnancy
Official title: A Comparison Between Vaginal Misoprostol vs. Buccal Misoprostol For Second Trimester Termination of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abortion, Induced
Keywords: misoprostol
Labor, Induced
Pregnancy Trimester, Second
Abortion, Induced
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 130
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy


Eligibility criteria: Inclusion Criteria:

* gestational age between 12-24 weeks
* live fetus
* singleton pregnancy
* Bishop score \<5
* no uterine contraction

Exclusion Criteria:

* prostaglandin allergy
* a scar in uterus
* uterine abnormality
* premature rupture of membranes

Primary outcomes:
measure: Induction to fetal expulsion interval
timeFrame: 15 minutes after fetus delivered
Secondary outcomes:
measure: Delivery within 24 hours
timeFrame: 24 hour
measure: Delivery within 48 hours
timeFrame: 48 hours
measure: Use of additional interventions
timeFrame: One week
measure: Expected pain before induction and perceived (actual) pain after abortion completed
timeFrame: within 1 hour after randomisation and after 12 hour after complete abortion/placenta removed
measure: Rate of complete abortion
timeFrame: 12 hour after fetus and placenta removed
Other outcomes:
measure: total misoprostol dose
timeFrame: 48 hours
measure: difference in hematocrit measured at entry of the study and after delivery/abortion
timeFrame: at recruitment and 24 hour after abortion
measure: maternal complications
timeFrame: one weeks
Locations:
city: Erzurum
country: Turkey
facility: Ataturk Universitesi Araştırma Hastanesi
Study officials:
affiliation: Ataturk University Faculty of Medicine
name: Ragıp A AL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University Faculty of Medicine
name: Ömer E Yapça, MD
role: STUDY_CHAIR
References:
citation: Al RA, Yapca OE. Vaginal Misoprostol Compared With Buccal Misoprostol for Termination of Second-Trimester Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):593-598. doi: 10.1097/AOG.0000000000000946.
Clinical trial NCT03146598: Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders
Official title: Use and Tolerability of a Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Disorder
Keywords: Foot deformity
Orthopaedic management
prevention
side pole static ankle foot orthosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient from the department of physical medicine and pediatric rehabilitation L'Escale (Lyon, France)

Brief summary: Transverse-plane foot deformities are a frequently encountered issue in children with neurological disorders. They are the source of many symptoms, such as pain and walking difficulties, making their prevention very important. It is thus important to prevent the occurrence of transverse-plane foot deformities and limit their development regarding the high risk of morbidity. In order to prevent such deformities, in the department of pediatric physical medicine and rehabilitation department of Lyon, since 2001 the investigator use a side pole static ankle foot orthosis (SPS AFO) in children with a neurological disorder predisposing such deformities. The aim of the study this study is to describe the use, tolerability and potential side effects of this orthosis in children with neurological disorders from the investigator's department


Eligibility criteria: Inclusion Criteria:

* regularly follow-up in the department of physical medicine and pediatric rehabilitation L'Escale (Lyon, France)
* presenting at least unilateral transverse-plane foot deformity within the context of a neurological disorder
* having a first prescription of SPS AFO between December 2001 and December 2011.

Exclusion Criteria:

* None

Primary outcomes:
measure: Duration of the SPS AFO wearing
timeFrame: At 3 months after SPS AFO implementation
Secondary outcomes:
measure: Frequency of the SPS AFO wearing
timeFrame: At 3 months after SPS AFO implementation
measure: Duration of the SPS AFO wearing
timeFrame: At 1 year after SPS AFO implementation
measure: Frequency of the SPS AFO wearing
timeFrame: At 1 year after SPS AFO implementation
measure: Duration of the SPS AFO wearing
timeFrame: at 2 year after SPS AFO implementation
measure: Frequency of the SPS AFO wearing
timeFrame: at 2 year after SPS AFO implementation
measure: Duration of the SPS AFO wearing
timeFrame: At 4 years after SPS AFO implementation
measure: Frequency of the SPS AFO wearing
timeFrame: At 4 years after SPS AFO implementation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03169998: Effect of Goal-directed Fluid Therapy on Postoperative Complications
Official title: The Effect of Goal-directed Fluid Therapy on Postoperative Complications in Patients Undergoing Laparoscopic Hepatobiliary or Pancreatic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Pancreas Disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 375
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is to be conducted in patients scheduled with laparoscopic hepatobiliary or pancreatic surgery, who are at risk either for taking 2 hours or more in surgery or to lose blood of 1000 ml or more.

Brief summary: * It has been known that the recent application of a goal-directed fluid therapy (GDFT) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with conventional methods.
* Laparoscopic surgery is in a trend that its application is being expanded recently, but there has been no report on the application of GDFT to laparoscopic surgery so far.
* To this end, this study aims to apply the intraoperative GDFT protocol in patients undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether there is any difference in postoperative recovery and incidences of postoperative complications, by comparing with patients applied with the fluid therapy using existing conventional methods


Eligibility criteria: Inclusion Criteria:

* Laparoscopic hepatobiliary or pancreatic surgery

Exclusion Criteria:

* Patients who do not consent to participation in the study
* Pregnant women, breastfeeding women

Primary outcomes:
measure: Pulmonary complication
timeFrame: Postoperative 90 day
measure: Wound complication
timeFrame: Postoperative 90 day
measure: Acute kidney injury
timeFrame: Postoperative 90 day
measure: Delirium
timeFrame: Postoperative 90 day
measure: Deep vein thrombosis
timeFrame: Postoperative 90 day
measure: Myocardiac infarction
timeFrame: Postoperative 90 day
measure: Stroke
timeFrame: Postoperative 90 day
measure: Sepsis
timeFrame: Postoperative 90 day
measure: Urinary tract infection
timeFrame: Postoperative 90 day
measure: Death
timeFrame: Postoperative 90 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT02165098: Cariprazine: Comparison of Slow- and Immediate-release Forms
Official title: A Single-Dose Study to Evaluate the Pharmacokinetic, Safety, Tolerability Profile and the Effects of Food on the Pharmacokinetics of Different Formulations of Cariprazine in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic Profile
Lead sponsor: Gedeon Richter Plc.
Sponsor class: INDUSTRY
First posted: 2014-06-17
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are doing this study to compare blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. The investigators will also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.

Detailed description: Comparison of blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. We'll also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.

Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian males aged 18-55 years with body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2
* Have a semisupine pulse rate ≥ 40 bpm and ≤ 100 bpm during the vital sign assessment at screening and on admission (Day 1)
* Agree to use an effective method of contraception and not have their partners become pregnant throughout the study and for up to 4 months after the administration of the IMP, or have been sterilized for at least 1 year

Exclusion Criteria:

-

Primary outcomes:
measure: C[max]
timeFrame: 0-672 hours
measure: AUC
timeFrame: 0-672 hours
measure: T[max]
timeFrame: 0-672 hours
Secondary outcomes:
measure: Other PK parameters of the parent drug
timeFrame: 0-672 hours
measure: PK parameters of the metabolites, if applicable
timeFrame: 0-672 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
References:
Clinical trial NCT00810498: Trilogy Comparison Study - Adults
Official title: Comparing Known Modes of Ventilation Delivered by Trilogy Versus Conventional Mechanical Ventilators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Respiratory Failure
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device). Both devices will be set to the participants' current mode and prescription settings.

Detailed description: A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as partial pressure of CO2 in arterial or venous blood)and SpO2 levels during various modes of ventilation.

B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).

Eligibility criteria: Inclusion Criteria:

1. Age \> 21 years of age; \< 85 years of age
2. Able to follow instructions
3. Able to provide informed consent
4. Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O.
5. Requiring mechanical ventilation through nasal/facial mask,tracheostomy or endotracheal tube (ET Tube)

Exclusion Criteria:

1. Clinically unstable, i.e.,

   1. Acute Respiratory Failure
   2. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents),
   3. Uncontrolled cardiac ischemia or arrhythmias,
   4. or as otherwise determined inappropriate for the study as determined by the investigator.
2. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
3. Pregnancy

Primary outcomes:
measure: Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).
timeFrame: After one hour of ventilator use
measure: Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.
timeFrame: After one hour of ventilator use
Secondary outcomes:
measure: Tidal Volume
timeFrame: One hour during ventilator use.
measure: Minute Ventilation
timeFrame: One hour during ventilator use.
measure: Hemodynamics (Heart Rate)
timeFrame: One hour during ventilator use.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Steven Mink, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00740298: Thermal Analgesia in Newborns
Official title: Thermal Analgesia in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: infants
undergoing
vaccinations
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-08-22
Enrollment: 178
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later childhood and may be related to the permanent neuroanatomical and behavioral abnormalities as found in animal models. Moreover, pain is a source of concern and distress for new parents. Yet, pain reducing therapies are often underused for the numerous minor procedures that are a part of routine medical and nursing care for neonates. Growing scientific and clinical literature provides evidence for the effectiveness of natural, non-pharmacological techniques in both animal and human newborns. This study compares the pain reliving effects of sweet taste to the combination of sweet taste and warmth.


Eligibility criteria: Inclusion Criteria:

* healthy infants

Exclusion Criteria:

* unhealthy infants

Primary outcomes:
measure: Decreased behavioral and physiologic indicators of pain
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Lawrence A Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: