cyrilzakka/clinical-trials huggingface dataset:
RPVI for Fluid Responsiveness in Children

The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children.

Children undergoing surgery under general anesthesia will be enrolled. After anesthetic induction, they will be assessed via transthoracic echocardiography for measurement of the patient's stroke volume index (SVI). Also, pleth variability index and Rainbow pleth variability index will be measured under mechanical ventilation with tidal volume of 6, 8, 10 ml/kg.

To exert fluid loading, 10ml/kg of crystalloid solution will be administered intravenously over 10 minutes. After fluid loading, the SVI will be measured again and fluid responsiveness will be determined according to increment ratio of the SVI.

According to the determined fluid responsiveness, predictive power of pleth variability index and Rainbow pleth variability index for fluid responsiveness will be assessed by building a receiver-operating characteristics curve.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing neurosurgery under general anesthesia

Exclusion Criteria:

* Presence of any cardiovascular disease
* Presence of any pulmonary disease
* Decline of enrollment from any of the patient's parents
Efficacy and Safety of DKB-119 in Patients in Crow's Feet

To prove the non-inferiority of DKB-119 by evaluating the injecting efficacy and safety DKB-119 and control for patients in crow's feet

A single center, randomized, subject and evaluator blinded, split-face, pivotal clinical trial

Eligibility Criteria:
Inclusion Criteria:

* Those who are over 19 under 70 ages.
* Those who score 2 or more in the LCL severity evaluation.
* Those who have visually symmetrical crow's feet on both sides.
* Etc.

Exclusion Criteria:

* Pregnancy and lactating women.
* Etc.
Interventions for Depressed Low Income Mothers and Their Infants

This study will compare three interventions for depressed, low income mothers and determine which is most effective in treating maternal depression and in fostering development in infants.

Poorly educated, low income mothers are at high risk for becoming depressed. The effects of living in poverty and being reared by a depressed parent can be detrimental to an infant's development. Effective interventions to reduce maternal depression and strengthen the mother-infant relationships are needed.

Participants will be randomly assigned to one of three groups. Group 1 mothers will receive 16 weekly sessions of interpersonal psychotherapy (IP) designed to directly treat maternal depression. Group 1 participants will have monthly follow-up visits for 1 year. Participants in Group 2 will receive 16 weekly sessions of IP followed by 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants. Group 3 mothers will be invited to attend informational meetings as well as be referred to local services available to people with depression.

All mother-child pairs will be evaluated when the child is 12, 16, 24, and 36 months of age. Evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures.

Eligibility Criteria:
Inclusion Criteria for Mothers:

* Current diagnosis of depression
* Mother of an infant 9 to 11 months of age
* Low income, defined as less than $25,000 for a family of two or less than $31,400 for a family of three (add approximately $7,960 for each additional family member)

Exclusion Criteria for Mothers:

* Current substance abuse
* Severe mental or physical limitations that would interfere with the study
Profile of COVID-19 Patients Related to Fatigue

More than half of recovered COVID-19 patients experience fatigue. Studies are needed to define the profile of these patients.

The objective of this study is to evaluate the profile of surviving patients of COVID-19 in relation to fatigue.

Background: More than half of recovered COVID-19 patients experience fatigue. Studies are needed to define the profile of these patients.

Objectives: Evaluate the profile of surviving patients of COVID-19 in relation to fatigue;

Methodology: Observational study. The profile of the survivors of COVID-19 will be described, dividing them into 2 groups based on the presence or absence of fatigue.

Patients will be recruited from the Virgen de las Nieves University Hospital in Granada.

The evaluation will be carried out through Google forms, telematic means or face-to-face depending on the variables.

A symptomatic evaluation of fatigue, aspects related to fatigue and physical performance will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COVID-19
* adults (\>18 years)
* basic knowledge and access to the internet
* wish to participate in the study and sign the informed consent

Exclusion Criteria:

* patients with severe comorbidities that interfere with the ability to perform the study, and those with mental, physical or organic problems that under medical criteria may pose a risk to the patient
Pilot and Feasibility Study of a Mirrors Intervention for Reducing Delirium in Older Cardiac Surgical Patients

This pilot cluster-randomised controlled trial aims to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.

The risk of delirium, an acute disturbance in mental status and cognition that occurs commonly after cardiac surgery, increases sharply from the age of about 65 years. Its occurrence, even for one day, is associated with longer ICU and hospital stays, increased costs, and negative physical and cognitive outcomes at one year. In spite of previous prevention and intervention research, delirium incidence in the older cardiac surgical patient remains high (up to 72%).

ICU clinicians at Papworth Hospital have made observations suggesting that delirium could be reduced using a novel and unconventional strategy of bedside mirrors. Mirrors of any type are uncommon in ICU environments\[1\], but their occasional use by patients on our ICU has been reported by bedside clinicians and physiotherapists to result in:

* a normalisation of mental status and attention (core delirium diagnostic criteria), and
* earlier physical mobilisation (associated with reduced delirium risk), particularly in older-aged patients

Evidence from other sources supports mirrors' beneficial effect in these areas \[2-10\], but mirror use has never to our knowledge been explored for the reduction of delirium. This pilot study seeks to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective or urgent cardiac surgery at Papworth Hospital
* aged 70+ years

Exclusion Criteria:

* inability to obtain informed consent
* care pathway anticipating admission elsewhere than to ICU following surgery
* severe visual impairment impeding ability to recognise self in mirror
* physical or communication barriers likely to impede effective administration of study procedures
* severe mental disability likely to impede effective administration of study procedures or assessment of delirium
* history of psychiatric illness previously requiring hospitalisation
A Study to Evaluate the Safety of AB-1003 (Previously LION-101) in Subjects With Genetic Confirmation of LGMD2I/R9 (Part1)

The purpose of this study is to evaluate the safety and tolerability of a single intravenous infusion of AB-1003 in adults diagnosed with limb girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). Participants will be treated in sequential, dose-level cohorts. (Part 1)


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged 18 and 65 years with clinical diagnosis of LGMD2I/R9 and confirmation of FKRP gene mutation.
2. Ability to ascend 4 stairs between 2.5 and 10 seconds.
3. Ability to walk/run 10 meters in \<30 seconds.
4. Able to understand and comply with all study procedures.
5. Sexually active females of childbearing potential and female and male partners of male subjects receiving study intervention must use a barrier method of contraception for the first 6 months after dosing.

Exclusion Criteria:

1. Significant cardiomyopathy as defined by echocardiogram (left ventricular ejection fraction \<40%), evidence of conduction defect (increased PR and RR intervals, left bundle branch block and QTcF \>480m/sec), NYHA Class 3 or 4 heart failure, or MRI gadolinium enhancement evidence of clinically important myocardial fibrosis.
2. Contraindication to MRI or hypersensitivity to contrast dyes, shellfish or iodine.
3. Implanted spinal rods, cardiac pacemaker or other implantation that would distort cardiac MRI images.
4. History of active, ongoing chronic liver disease (e.g. hepatitis, HIV-related liver disease, hemochromatosis, steatosis, etc.) or abnormal liver function tests (abnormal GGT and/or abnormal total/direct bilirubin \>upper limit of normal \[ULN\] and/or elevated AST and ALT \>2 ULN).
5. Abnormal renal function (GFR \<60 ml/min, using the Modification of Diet in Renal Disease equation).
6. Any life-threatening disease, including malignant neoplasms and medical history or malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
7. In the opinion of the investigator, a pre-existing medical condition that predisposes the subject to risks that outweighs the potential benefits.
8. Requirement for daytime ventilatory support.
9. Change in glucocorticosteroid treatment within 3 months prior to screening visit.
10. Exposure to another investigational drug within 3 months prior to study treatment or any previous treatment with gene therapy.
11. Ongoing participation in any other therapeutic clinical trial.
12. Neutralizing antibody titer to AAV9 ≥1:5.
13. Female subjects who are pregnant, plan to become pregnant in the next 12 months, or breastfeeding.
Polscope Sperm: A Non-invasive Method to Assess DNA Damage in Individual Sperm

The purpose of this study is to find a non-invasive way to discover DNA (deoxyribonucleic acid, which is the genetic material inside your cells) alterations in the sperm's head, in the near future leading us to choose the "good sperm" in a simplified manner. This could then increase chances of a successful in-vitro fertilization (IVF) treatment when there are sperm abnormalities.

If you take part in this study,

1. Your physician is asking you to provide a semen sample as you already would. The sample will be taken to the IVF lab which would occur if you were not involved in this research. The part that would be thrown away is then further analyzed under a polarized light microscope. The sample is exposed to ultraviolet (UV) light for a period of 20 minutes after which it is analyzed under the microscope again, looking for any changes when compared the sample that was not exposed to UV light. The sample is then discarded.
2. Your name will be removed from the sample after the regular semen analysis is done; therefore there will be no way of associating the research results with you. No information will be needed from you and you will not be contacted in the future regarding this research.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* provide informed consent
* Already providing a semen sample as routine therapy in IVF

Exclusion Criteria:

-unable to provide informed consent
Conventional-therapy & FES-therapy In-Veritas Effects Study

This randomized clinical trial will primarily compare the effectiveness of conventional physiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy.

This randomized clinical trial will primarily compare the effectiveness of conventionalphysiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy. Secondarily, this clinical trial will evaluate the effectiveness of combined conventional physiotherapy and FES-t along with task-specific training outcome compared to conventional physiotherapy alone with regards to improved connectivity andexcitability in the ascending and descending pathways as assessed using neurophysiological tests and functional MRI analysis.

Eligibility Criteria:
Inclusion Criteria:

* New unilateral or bilateral, persistent C5 palsy (for at least 3 months) after surgical treatment for degenerative cervical myelopathy

Exclusion Criteria:

* Contraindication for FES-t
* Contraindication for neurophysiological testing
* Contraindication for MRI scanning
* Uncontrolled cardiovascular conditions
* Other medical conditions that can limit treatment protocols
* Other neurological diseases
* Significant persisting mental illness
* Diagnosed learning disabilities
* Substance abuse over 6 months prior to recruitment
* Hearing and visual deficits sufficient to affect test performance
* Reduced passive range of motion (ROM) of the shoulder ("frozen shoulder")
* Inability to participate in and intensive outpatient rehabilitation program
Peer Support Program in Chronic Kidney Patient

The main advantage of patient-to-patient peer counseling is that it benefits both the client and the peer mentors as real and authentic experiences are shared. Since both individuals go through similar experiences, they can share common feelings. Although there are studies in the literature showing the effectiveness of peer support groups in different patient groups, studies on chronic kidney disease patients are limited. There are no studies on the effects of these programs on caregivers. This study will be conducted to examine the effects of peer support program applied to chronic kidney patients on patient outcomes and caregivers.

This study was planned to be conducted with a randomized controlled experimental design to examine the effect of the peer support program applied to Chronic Kidney patients on patient outcomes and caregivers.

Patients diagnosed with Chronic Kidney Disease and receiving haemodialysis (HD) as a renal replacement method constitute the population of the study. In the a priori power analysis performed to calculate the number of subjects, the effect size was taken as 1.3 (d) based on reference studies. Accordingly, it was found that 34 subjects should be included in the calculation for the independent two-sample t-test according to 0.95 power and 0.05 alpha. The sample of the study will consist of 25 intervention and 25 control CKDs who fulfil the inclusion criteria, taking into account the dropout status.

Eligibility Criteria:
Inclusion and Exclusion Criteria For Peer Mentor Inclusion Criteria;

* Speaking Turkish
* To be literate
* CKD receiving haemodialysis
* Volunteering
* 18 years of age or older
* Being open to communication and co-operation
* Not having any psychiatric disorder

For Patient Inclusion Criteria;

* Speaking Turkish
* To be literate
* CKD receiving haemodialysis
* Volunteering
* 18 years of age or older
* Not having any psychiatric disorder

Exclusion criteria for all participants

* Being under 18 years of age
* Speaking a language other than Turkish
* Not being able to use a telephone

Losses to follow-up

* Experiencing incompatibility with the second peer mentor or client with whom they are paired for peer mentor and peer client
* Death during the period of intervention or follow-up
* Withdrawal of patient consent
* Clinical problems or difficulties attending appointments that hinder follow-up
Pregnancy and Growth of Adolescent Mothers and Their Child

This study intends to observe the epidemiology of pregnancy and growth of adolescent mothers and their child in their first year on the development and growth ambulatory at Brasilia University Hospital (HUB).

The study hypothesis is that adolescent growth is disturbed by a pregnancy in this age. Another hypothesis is that their child's growth and development could be obstructed.


Eligibility Criteria:
Inclusion Criteria:

* in the HUB ambulatory of growth and development pediatric center

Exclusion Criteria:

* mothers who are more than 19 years old
Treadmill Training in People With Parkinson's Disease

The study will explore if coupling speed and cadence during treadmill training elicit more benefits than controlling speed alone in individuals with Parkinson's disease.

Impaired gait is prevalent and raises the fall risk in people with Parkinson's Disease (PwPD). Gait speed, step length, and cadence are three interrelated components of human gait, as speed is determined by step length and cadence. Auditory cues, such as metronomes, have been shown to aid training for PwPD. The purpose of this study is to examine if controlling cadence and speed improves overground gait parameters in PwPD better than only controlling speed. Two groups of PwPD will participate. Both groups will attend a single treadmill training session. Both groups will complete overground walking trials as a pre-test measurement. One group will receive treadmill training in which cadence, via a metronome, and speed are controlled, while only speed is controlled for the other group. Both groups will complete the same overground walking trials as a post-test measurements. The specific aim of this study is to determine the effects of metronome cues and gait speed versus gait speed alone treadmill training on spatiotemporal gait parameters when walking overground in PwPD.

Eligibility Criteria:
Inclusion Criteria:

* Can read and understand English
* Between the ages of 18-89 years old
* Diagnosed with Parkinson's Disease
* Stage 1-3 based on the Hoehn and Yahr
* Able to walk overground more than 15m independently
* Able to walk on a treadmill for at least 15 minutes independently

Exclusion Criteria:

* Diagnosed with any uncontrolled cardiorespiratory or metabolic disease
* Experience any other known neurologic disorders that affect their ability to walk
* Diagnosed with any visual or communication disorders
* Suffered a lower extremity injury within the last 6 months
Prevention of Maternal and Fetal Metabolic Complications With Diet and Nutraceutical Supplementation in Pregnant Women Affected by Gestational Diabetes: a Randomized, Double-blind Placebo Controlled Trial.

Our trial aims to assess the effect of nutraceutical supplements (omega-3 fatty acids, anthocyanins and alpha-cyclodextrins) in patients affected by gestational diabetes.

Pregnant women with gestational diabetes at 24-28 weeks of gestation are enrolled in a double-blind trial and randomized to receive either nutraceutical supplements or a placebo for 12 weeks.

Randomized, Double-blind trial Aims: evaluation of the metabolic effect on patients affected by gestational diabetes of anti-inflammatory, anti-oxidant nutraceutical supplementation with omega-3 fatty acids, anthocyanins and alpha-cyclodextrins for 12 weeks associated with appropriate nutritional coaching versus nutritional coaching and placebo.

All women receive a personalized diet by a nutrition expert educator and should monitor capillary blood glucose levels. Patients receive twice-weekly antenatal testing, including ultrasonography for fetal growth and well-being maternal weight body fat mass distribution evaluation using skinfold caliper, dietary counselling. Blood and urine samples are drawn from all patients at recruitment and at the last study visit.

Eligibility Criteria:
Inclusion Criteria:

* patients between 24 and 28 weeks of gestation with positive result to an Oral Glucose Tolerance Test with 75 gr glucose performed after 24 gestational weeks, according to the International Association of Diabetes and Pregnancy Study Group (IADPSG) recommendations (at least one of the following criteria: baseline glycemia ≥ 92 mg/dl, 1-h glycemia ≥ 180 mg/dl, 2-h glycemia ≥ 153 mg/dl)
* maternal age ≥ 18 years.

Exclusion Criteria:

* multiple pregnancies
* fetal malformation
* maternal diseases (type 1 and type 2 diabetes, hypothyroidism and hyperthyroidism, immunological disorders)
* abnormal blood glucose values before 24 weeks of gestation.
Study to Test the Effectiveness of a New Treatment for Scalp Psoriasis

The purpose of this study is to test the effectiveness of DermiPsor's DPS-102 (test product) in patients with scalp Psoroasis. The study is also intended to assess the safety of the product.

Psoriasis is a non-contagious skin disorder affecting up to 2% of the world population. It is estimated that 26 million people in the U.S. and Europe suffer from psoriasis. Forty percent (40%) of these suffer from psoriasis of the scalp. Currently, there are three primary modalities for the treatment of psoriasis: topical, phototherapy and systemic treatments. While existing treatments provide varying degrees of relief for this illness, they do not provide a long-term cure. Additionally, there is evidence that some of these existing treatments may cause significant side effect. The purpose of this study is to demonstrate that DermiPsor's DPS-102 (test product) is statistically more effective for the treatment of psoriasis current topical treatment options. It is also intended to assess the safety of DPS-102.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of age 18 or older
* Patient with a personal history of scalp psoriasis
* Patient with treatable lesions
* Patient with a TSS score equal or lower than 9.
* Patient with a PGA score equal or lower than 5.
* Patient with a negative urine pregnancy test at inclusion for women of childbearing potential and using an efficient contraceptive (oral contraceptives, IUD, or tubal ligation)
* Patient agreeing to participate to the study and to sign a written informed consent and comply with study requirements.

Exclusion Criteria:

* Patient treated with topical scalp treatment for scalp psoriasis within two weeks prior to the inclusion in the study (corticoids, retinoids, vitamin D derivatives),
* Patient treated with systemic treatment for psoriasis (biologics, methotrexate, cyclosporine, retinoids) within one month prior to the inclusion in the study
* Patient taking systemic niacin or multivitamins within past two weeks
* Patient who start or modify a treatment with beta-blockers within one month prior to the inclusion in the study
* Patient with PEG (Poly Ethylene Glycol) allergy
* Pregnant or breast feeding female or female who do not use contraception,
* Patient with an history of hypersensitivity to Dovonex/Daivonex
* Patient who has participated in a clinical trial within three month prior inclusion,
* Patients on Carbamazepine and Primidione (the clearance of Primidione and Carbamazepine may be reduced with the concomitant use of Nicotinamide)
* Patient who is under guardianship, or unable to understand the information (for linguistic or mental reason), or unwilling to give her/his informed consent to participate in the study