cyrilzakka/clinical-trials huggingface dataset:
Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia

The purpose of the study is to determine the effect of spring gravity bar on gait pattern in children with spastic diplegia

The purpose of this study is to provide insight on investigate the effectiveness of vestibular stimulation on gait pattern by using spring gravity bar , when you bounce up and down it stimulate vestibular system that is considered straight line vestibular stimulation and strength extensor muscle of lower limb by pressure on spring during stance phase all that change gait stability and stride length so can improve gait pattern .

Eligibility Criteria:
Inclusion Criteria:

1. Their age will be extended from 7 to 10 years.
2. They can walk with limitation or holding on according to GMFCS (level II \& II).
3. They can understand and follow instruction.

Exclusion Criteria:

- 1-children with any visual or auditory abnormalities. 2-children receiving any special medication affecting muscle and /or mental function.

3-children had any recent surgical interference in the lower limb. 4-children with perceptual defects. 5-children with fixed structural deformities lower limb.
Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications

The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female ambulatory outpatient age 19 or older.
* Patients meet ROME II Criteria
* Patients not meeting ROME IBS criteria
* Use of a constipating medication (\>= 3% in PDR)
* If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study
* Written informed consent.

Exclusion Criteria:

* Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
* Prior small bowel or colonic resection or colostomy.
* Weight \< 80 lbs.
* Unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications.
* Positive stool hemoccult.
* Significant cardiac, renal or hepatic insufficiency.
* Pregnant or expecting to become pregnant within 120 days of study enrollment.
* Lactating or breast feeding.
* Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
* Use of investigational drugs in the last 30 days.
* Patients with known allergy to PEG or PEG medications such as PEG or sulfate-free electrolyte lavage solutions
Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants

Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV).

Premature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.

To compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm \< 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and/or sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.

Improvement and optimization of non-invasive ventilation (NIV) in preterm and low birth weight infants is essential in order to reduce morbidity. By the use of 3D printing design (3DM), these infants would be provided with customized nasal masks, according to their particular anatomical features while on NIV. This would lead to a greater stabilization of the respiratory system, decreased apnea spells, oxygen desaturation and bradycardia, less need for intubation and less skin nose injury, all of which might improve neurodevelopmental outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Newborn prematurity
* Age: less than 30 days of life
* Required respiratory support with non-invasive ventilation (NIV)
* Premature infant has not been on NIV for more than 3 days before being included in the trial.
* Signature of the Informed Consent (IC)

Exclusion Criteria:

* Failure to meet entry criteria
* Cyanotic congenital heart disease diagnosis
* Presence of serious malformations
* Presence of airway malformations
Obstetric Anaesthesia And Analgesia Month Attributes - in COVID-19

A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia and to evaluate the impact of COVID-19 pandemic on obstetric anesthesia and analgesia in Czech Republic and Slovak Republic

A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia departments throughout the Czech Republic and Slovak Republic.

Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia procedures in peripartal period and obstetric and anesthesia complications. All consecutive cases in each participating center during the study period are recorded. Each record is related to parturient and contains the following sections: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.

Eligibility Criteria:
Inclusion Criteria:

* Women in labor undergoing anesthesia care

Exclusion Criteria:

* not meeting inclusion criteria
Pain Measurement and Pain Management in the Intensive Care Unit(ICU)

The purpose of this study is to evaluate the effect of a pain training program and systematic measurement of pain scores on actual pain levels and the use of analgesics in critically ill patients.

Systematic evaluation of pain, though still not common practice in all ICUs, is recommended in clinical practice guidelines for optimal pain management. Pain is a frequently experienced problem in patients in the Intensive Care Unit(ICU). In search of literature to support the need for introduction of a pain management system and to train the entire health staff in our department little information was found concerning the effects of pain training and pain management systems in the ICU. The small number of available studies may be explained by the difficulty of systematic pain measurement in ICU patients, mainly due to the inability to communicate effectively with these patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the ICU of the St. Antonius hospital, \>18 years old.

Exclusion Criteria:

* Patients who are suspected to be brain-dead
Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.

Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a special group who need special attention. Some studies have shown that cartoons are a very good tool for distraction in the preoperative period for children.

Our hypothesis is that children watching Cartoons in the preoperative period will have less anxiety and will be fit with preparation.

After local ethics committee approval 60 patients scheduled for various types of surgery will be included.

On the operation day patients are going to be evaluated in the preoperative preparation room. For anxiety evaluation the modified yale preoperative anxiety scale will be used. After this first evaluation patients are going to be separated randomly into two groups; group R (routine) and group C (cartoon). All patients are going to be premedicated with midazolam. The first group will receive their premedication straight after the first evaluation and their response will be recorded as easy, moderate, difficult, does not accept. Group C will choose a cartoon movie (5 different movies are recorded and will be shown through a tablet PC)) and will begin to watch it. After 5 minutes they will receive their premedication and their response will also be recorded. After 30 minutes a physician will try to insert an IV line and the response of the child will also be evaluated and recorded as easy, moderate, difficult and does not allow. Afterwards the patient will be transported into the operation room. In the operation room anesthesia will be induced via Sevoflurane and the response to mask anesthesia will be evaluated with the mask score as it is described before in previous studies. Patients in Group C will continue to watch the cartoon movie until the induction of anesthesia. And the modified yale score will also be reevaluated and recorded.

The family anxiety will be evaluated with the State Trait Anxiety Inventory Scale.

The family and the child will also be interviewed separately, 4 prepared standard questions will be asked in order to understand how the family described the operation.

Eligibility Criteria:
Inclusion Criteria:

* family approval
* age between 3-9
* scheduled for surgery under general anesthesia

Exclusion Criteria:

* history of physiatric disease
* regular medication
* previous history of anesthesia/sedation
Study of ATH434 in Participants with Multiple System Atrophy

This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy


Eligibility Criteria:
Inclusion Criteria:

1. Participant has clinical features of parkinsonism.
2. Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
3. Participant has ataxia and/or pyramidal signs on neurological examination.
4. Participant is ambulatory.
5. Participant has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion Criteria:

1. Participant has motor symptoms for \> 4 years.
2. Participant has advanced disease, as indicated by frequent falls or choking.
3. Participant has structural brain abnormality on MRI.
4. Participant has any significant neurological disorder other than MSA.
5. Participant has an unstable medical or psychiatric illness.
6. Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.
COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor-2

Capture of anxiety for anomalies, stillbirth and preterm labor of pregnant women during COVID-19 pandemia


Eligibility Criteria:
Inclusion Criteria:

* consenting ability

Exclusion Criteria:

* language barrier
* uncompleted questionary
Caring Hand Massage - an Intervention in Cancer Patients Undergoing Chemotherapy in an Outpatient Setting - a Pilot Study

Since there is a limited amount of evidence on the feasibility and outcomes on the use of hand massage in patients undergoing cancer treatment, the purpose of this study is to evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing chemotherapy, and to measure its influence on their symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18 - 80
2. Patient receiving treatment on Mayo Clinic's Chemotherapy Outpatient Clinic
3. Able to speak English and complete surveys
4. Able to read, understand and sign inform consent.

Exclusion Criteria:

1. Patient has rash, sores, wounds, incision or other skin conditions on hands
2. Unable to give consent or complete the surveys
3. Already having received previous hand massage
4. Pregnant women. (As verbalized by participant)
Factors Affecting the Improvement of Severity of Concomitant USI After a Novel TVM Surgery for Women With POP

Background/Purpose:

A novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.

Patients and Methods:

All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline \[i.e., 100 \* (postoperative pad weight - baseline pad weight)/baseline pad weight\].

Expected Results:

The investigators will get the factors responsible for anti-incontinence effect of this novel anterior TVM surgery. Key Words: pelvic organ prolapse, stress urinary incontinence, pad test, urodynamic stress incontinence

Background/Purpose:

A novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.

Methods:

All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries between November 2011 and December 2015 at the Department of Obstetrics \& Gynecology, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline \[i.e., 100 \* (postoperative pad weight - baseline pad weight)/baseline pad weight\].

Expected Results:

The investigators will get the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Diagnosed with pelvic organ prolapse and concomitant overt or occult urodynamic stress incontinence
* Received the novel anterior transvaginal mesh surgery.

Exclusion Criteria:

* Pregnant women, prepare for pregnancy or younger than 20-year-old
* Significant severe urinary urgency
* Mixed urinary incontinence with dominant urgency incontinence
* Regular urethral catheterization or intermittent self-catheterization
* Urinary tract infection (UTI) or chronic inflammation in recent 2 weeks before operation
* Bladder calculus
* A history of pelvic radiotherapy
* Preexisting malignant pelvic tumors.
Building Resilience @ Work Training Among Healthcare Workers

Background Given that the challenges in adjusting to shifting work, physical workload and high-strung nature, healthcare workers often encounter high stress, emotional exhaustion, low empathy, fatigue and burnout, which, in turn, result in sickness, absence, and high turnover. Hence, building resilience for future adversity among healthcare workers in the workplace is necessary.

Objectives To evaluate the effectiveness of the Building Resilience at Work (BRAW) on resilience, job engagement, intention to leave, employability, and work performance To explore healthcare workers' experience of the BRAW intervention.

Methods This study will evaluate the effectiveness of BRAW using a sequential mixed methods design in two phases. In phase I, a two-armed randomized controlled trial will be conducted to compare resilience, work engagement, coping skills, job satisfaction and life satisfaction with a waiting list control condition among 410 healthcare workers.

In phase II, the investigators will conduct a virtual individual interview to explore experiences on usability and acceptability after receiving the BRAW intervention using a sample of 33 healthcare workers.

Significance of research Considering the multifactorial and complexity of resilience at work in an increasingly dynamic healthcare environment, the content of resilience training can promote resilience, work engagement, coping skills, job satisfaction and life satisfaction among healthcare workers in order to reduce the turnover rate among healthcare workers in Singapore.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers aged 21 years or older
* Can read English
* Own and regularly use smartphone, tablet, laptop or desktop
* Can access the internet

Exclusion Criteria:

* Previous diagnosis of psychosis, severe depression, personality disorder and substance abuse at any point in their life
Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Hepatically impaired groups:

  * Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
  * Have mild hepatic impairment (Child-Pugh Clinical Assessment Score Grade A, score 5 6) or moderate hepatic impairment (Child-Pugh Clinical Assessment Score Grade B, score 7-9) or severe hepatic impairment (Child-Pugh Clinical Assessment Score Grade C, score 10-15);
* Control group

  * Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
  * Healthy as determined by medical history, physical exam, vital signs, ECGs, and clinical laboratory tests.

Exclusion Criteria:

* Hepatically impaired groups:

  * Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
  * Have any acute or unstable condition or disease, other than impaired hepatic function, as determined by medical history, physical exam, ECG and clinical laboratory tests;
  * Known ongoing alcohol and/or drug abuse within 1 month
  * Any evidence of progressive worsening liver function disease as indicated by laboratory values;
  * Have had an acute flare of hepatitis A or B within 6 months;
  * Have acute, fulminant alcoholic hepatitis, determined either clinically or by histology;
  * Have a history of hepatoma or metastatic disease of the liver;
* Control group:

  * Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
  * Have a history or presence of clinically cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, psychiatric, pulmonary, or renal disease or any other condition.
Antibiotic Therapy for Infectious Diseases

Tigecycline is a last-resort antibiotic that is used to treat severe infections caused by extensively drug-resistant bacteria. However, the efficacy and safety data for tigecycline in infectious patients are lacking. The aim of this study is to assess the efficacy and safety of tigecycline in infectious patients using pharmacokinetics and omics.


Eligibility Criteria:
Inclusion Criteria:

* critically ill hospitalized males or nonpregnant females aged 18 years with severe infections which the treating clinician was treating with tigecycline

Exclusion Criteria:

1. severe liver dis- eases (e.g., Child-Pugh score C);
2. patients allergic to tetracycline and tigecycline;
3. those who have participated in other clinical trials, or those who are considered unsuitable by researchers;
4. pregnant women and lactating women.
Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns

The purpose of this work is to assess the functional state of the body of medical workers in the neonatal resuscitation and intensive care unit in the conditions of work.


Eligibility Criteria:
Inclusion Criteria:

* the volunteer has practical experience in the neonatal intensive care unit
* digestive tract, kidney, cardiorespiratory system, mervous system or musculoskeletal system pathology

Exclusion Criteria:

* acute and chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys
* body temperature above 37 ° C, heart rate over 90 beats / min, systolic and diastolic blood pressure above 140 mm Hg. Art. and 90 mm Hg. Art.
* organic brain lesions, increased convulsive activity in history
* receiving more than 10 units. alcohol per week or history of alcoholism, drug addiction, drug abuse
Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section

Purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean section with one or more risk factor for postpartum hemorrhage.

Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries. The risk of PPH is much higher for women undergoing cesarean delivery (CD). Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a single-dose injection; intravenously administered carbetocin has a half-life of approximately 40 min.

A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection.

The aim of this study is to compare the effectiveness of combined tranexamic acid (TA) and oxytocin infusion with intravenous carbetocin for prevention of PPH in patients with risk factors during cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Women who undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation
* With fetal macrosomia, polyhydramnios, low insertion of the placenta, multiple gestations, prolonged labor, chorioamnionitis, past history of PPH, diabetes and high parity (5 previous deliveries).

Exclusion Criteria:

* suspected coagulopathy,
* history of coronary artery disease or hypertension,
* women with a history of hypersensitivity to carbetocin, TA or oxytocin
* general anesthesia, and
* PPH due to causes other than uterine atony.
Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with uncontrolled hypertension and at least one antihypertensive medication. Those patients with significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
* Current treatment with at least 1 antihypertensive drug

Exclusion Criteria:

* Age \<18 and \>65 years
* BMI ≥ 40 kg/m2
* Heart failure, EF \< 45%, acute myocardial infarction, stroke, significant valvular dysfunction
* Chronic renal failure (serum creatinine \> 2 mg/dL)
* Use of cocaine, amphetamines, alcohol, illicit drugs
* Use of sympathomimetics (decongestants, appetite suppressants)
* Use of oral contraceptives and chronic use of NSAIDs
* Pregnancy
* Secondary causes of hypertension (other than sleep apnea)