cyrilzakka/clinical-trials huggingface dataset:
Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen

To investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers, receiving study drug over the course of 7 days.

The primary objective of this project is to investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers. Based on the results of this study, if one enantiomer seems to show a better safety profile (in terms of hematological effects), an analogous study will be carried out in G6PD deficient individuals (under a separate protocol). The studies are primarily aimed at understanding the tolerability and safety of the enantiomers in G6PD deficiency. If one shows a better safety profile, ultimately the evaluation of its efficacy will be required.

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy adults aged 18 to 65 years

Exclusion Criteria:

* Known history of liver, kidney or hematological disease
* Known history of cardiac disease, Non Sinus Rhythm arrhythmia or QT prolongation
* Autoimmune disorders
* Report of an active infection
* Evidence of G6PD deficiency
* Participant is pregnant or breast-feeding, or is expecting to conceive during the study.
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.

The study is a prospective, randomized, four-arm, dose-escalating, double blind, placebo controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of four dose levels of MTR105 in patients undergoing cardiac surgery utilizing cardiopulmonary bypass presenting hypotension upon weaning off bypass.

Eligibility Criteria:
Inclusion Criteria:

* Men or women age 18 years or older
* Referred for cardiac surgery requiring the use of CPB.
* Elective or urgent surgeries (non emergency operations).
* LVEF ≥40 based on cardiac catheterization results
* Normal renal function at study entry
* Normal hepatic function (within normal laboratory ranges) at study entry
* Normal coagulation status at study entry as judged by PT, PTT, fibrinogen and platelet count.
* Willingness to participate in the study and adhere to the study design.
* Willingness to sign an informed consent form.

Exclusion Criteria:

* Emergency operation
* Pulmonary hypertension (PA systolic pressure \>60 mmHg)
* Ejection fraction less than 35% during weaning from bypass or cardiac index of less than 1.8
* Neurological events such as prior CVA, TIA or symptomatic carotid stenosis within 1 year of presenting for surgery
* Body weight \<40 Kg
* Pregnancy
* Malignancy within 1 year of presenting for surgery
* Systemic infection as evidenced by elevated WBC or fever \>38.5 C
* Usage of vasoactive medications within 24 hours except short term use of a vasoconstrictor during induction.
* Participation in any other investigational drug or device study within 30 days of randomization
Plantar Fasciitis Foot Insole

The hypothesis to be tested is that the use of total contact insoles for six months reduces foot pain, improves function and quality of life of patients diagnosed with plantar fasciitis.

Patients diagnosed with plantar fasciitis, foot pain with VAS between 3 - 8 for walk, over 18 years, regardless of gender who agreed to participate and signing the consent form. Pacietes We excluded patients with other symptomatic lower limb musculoskeletal diseases, diabetes mellitus, rigid deformities in the feet, which made use of insoles, physiotherapy or injections in feet and ankles in the last three months, and previous surgery or planned within the next twelve months.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with a diagnosis of PF and foot pain while walking ranging from 3 to 8 points on a 10-point pain scale were analyzed

Exclusion Criteria:

* Patients with other musculoskeletal conditions in symptomatic lower limbs, inflammatory conditions of the central or peripheral nervous systems, diabetes mellitus or an inability to walk.
Memantine in Adult Autism Spectrum Disorder

The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).


Eligibility Criteria:
Inclusion criteria

* Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC)
* Participant has a diagnosis of:

  * Autistic Disorder
  * Asperger's Disorder
  * Pervasive Developmental Disorder (PDD) NOS
* Participant meets one of the following criteria:

  * CGI-S \>= 4 (CGI-S: ________)
  * Participant has the following problematic behaviors (at least one) that might be expected to benefit from memantine:

    1. _____________________________________________
    2. _____________________________________________
    3. _____________________________________________

Exclusion criteria

The patient meets none of the following criteria (mark if absent):

* Active seizures (Patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible).
* Rett's Syndrome or Childhood Disintegrative Disorder
* Active treatment with an acetylcholinesterase inhibitor
* Prior or current treatment with memantine
* Current treatment with lamotrigine
* Genetic, metabolic or degenerative disorder (excepting Fragile X).
* Brain malformation or known severe brain trauma
* Pregnancy or breastfeeding
* Glomerular Filtration Rate (GFR) \< 30 mL/min
A Gluteus Maximus Strength Exercise Effectiveness for Improving Dynamic Postural Control in Female Basketball Players

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. A total of 92 female basketball players aged between 12 and 25 will be selected and randomized in two different groups.

The control group will carry out a conventional preventive work out and the experimental group will carry out a specific strengthening program for the gluteus maximus in addition to the conventional preventive exercises.

The treatment will take place during the basketball club season and will last 4 months, from January to April 2022.

The objective is to evaluate the effectiveness of the inclusion of a specific gluteus maximus strength program in the conventional preventive work to improve the dynamic stability and to reduce the injury rate and pain in female basketball players.


Eligibility Criteria:
Inclusion Criteria:

* Female basketball players belonging to a sports club.
* Female basketball players between 12 and 25 years old.

Exclusion Criteria:

* Acute lower limb injuries at the start of the study.
* Surgery on the lower limb in the previous year.
* Injuries or diseases that prevent the correct performance of the evaluation tests.
Evaluation of Upper Abdomen Imaging With Low Field MRI Scanner (0.4T)

The goal of this observational, cross-sectional, prospective study is to compare the quality of the image obtained on the upper abdomen organs with a low-field 0.4 T MRI system with the one obtained with a high-field 1.5 T MRI system, taken as a comparator and reference device.

The study is conducted on 40 consecutive adults, not vulnerable, patients who are already scheduled for diagnostic imaging examinations on the upper abdominal organs with the reference device.

The Primary endpoint of the study is to :

a) compare the image quality of the upper abdominal organs obtained with 0.4 T systems and with 1.5 T systems; This will be assessed via a noninferiority study on image quality. The image quality will be assessed by two experienced radiologists (more than 5 years' experience) and a trainee radiologist (at least 2 years) via blinded independent readings of the diagnostic images acquired both on the low-field 0.4T MRI device and on reference device e.g. the high-end 1.5T MRI device

Secondary endpoints of this study are:

1. evaluate the accuracy of representation and measurement (diameters, volumes) of the gallbladder and bile and pancreatic ducts;
2. compare the exam comfort with 0.4 T systems and with 1.5 T systems by means of questionnaires on the exam comfort provided to the subjects

Eligibility Criteria:
Inclusion Criteria:

* all subjects (in-patients or out-patients) who go to the diagnostic clinical center with the indication of performing an upper abdomen MRI examination with MRI 1.5T
* age :18 years old or higher
* the subject must be capable and willing to fulfill all study requirements

Exclusion Criteria:

* pregnancy,
* poor cooperation
* claustrophobia (only for 1.5T MRI)
The DNA Methylation of ARHGEF11 in Macrosomia

Background Macrosomia at birth is associated with subsequent susceptibility to obesity, abnormal glucose metabolism, hypertension and dyslipidaemia. Epigenetic reprogramming has been reported to be involved in the development of human diseases caused by suboptimal environmental or nutritional factors.

Objective The study was aiming to explore epigenetic mechanism influences on macrosomic infants exposed to intrauterine hyperglycemia.

Design The investigators performed a genome-wide analysis of DNA methylation in cord blood from macrosomic infants born to women with gestational diabetes or infants with normal birth weight born to normal glucose-tolerant women in order to identify genes related to foetal growth or early adipose tissue development. The candidate genes were then validated using SEQUENOM MassARRAY after bisulfite conversion.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Pregnancies complicating with hypertensive disorders, pre-gestational diabetes, thyroid diseases, renal dysfunction were excluded.
A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.

This study will test whether vaccination with viagenpumatucel-L combined with low-dose cyclophosphamide will prolong the survival of patients with non-small cell lung cancer (NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone. Patients will be randomized 2 to 1 into the viagenpumatucel-L arm and the chemotherapy alone arm, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung adenocarcinoma
* At least 2 and no more than 3 prior lines of therapy for incurable or metastatic NSCLC
* Suitable for conventional single agent chemotherapy
* Disease progression at study entry
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1; PS=2 patients may be considered
* Central nervous system (CNS) metastases may be permitted but must be treated and neurologically stable
* Adequate laboratory parameters
* Willing and able to comply with the protocol and sign informed consent
* Female patients who are of childbearing potential and fertile male patients must agree to use an effective form of contraception throughout study participation

Exclusion Criteria:

* Received systemic anticancer therapy or radiation therapy within the previous 14 days
* Received more than 3 lines of prior conventional therapy for advanced disease
* Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy
* Any condition requiring concurrent systemic immunosuppressive therapy
* Known immunodeficiency disorders
* Known leptomeningeal disease
* Other active malignancies
* Prior treatment with a cancer vaccine for this indication
* Pregnant or breastfeeding
Comparison of Wide-field Retinal Imaging

Fundus imaging has become an integral tool in retinal diagnosis. Although single-field fundus photography covers a vital region of the retina, it leaves a large portion of the periphery undiscovered.

Ultra-wide-field imaging systems allowed for visualization of peripheral perfusion abnormalities in myopic eyes that were previously unknown.

In Austria, there are two different wide-field imaging systems available. The first device on the market was the Optos (Optos PLC, Dunfermline, UK) and several years later the Clarus 500 (Carl Zeiss, Meditec AG, Jena, Germany) was introduced.

While both of the studied imaging systems have the possibility of a 200° view of the retina, we would asses if the differences between the two devices affect the extent of retinal periphery view and if ocular ametropies which come with different retinal pathologies would affect the retinal periphery assessment.

Aim: To compare two CE-marked imaging systems concerning the extent of retinal periphery area viewing.

We would like to perform a prospective observational study that would include patients divided into three groups: myopic patients, hyperopic and emmetropic patients.

Fundus photography will be performed using two ultra-wide-field imaging systems (Optos, Daytona, Optos PLC, Dunfermline, UK and Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany), performed by the same investigator.

All images with sufficient quality will be exported and saved to hard-disk. The difference in periphery view will be investigated as follows: two retinal photos for each patient will be imported into Photoshop CS6 image-editing system (Adobe, version 13.0.0) where the anatomical landmarks will be matched for each image and the borders will be compared to see if there are differences in retinal periphery area viewing between the two devices.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 21 years old
* Myopic (at least -5.00Dsph), hyperopic (over +3.00Dsph) and emmetropic patients
* Written informed consent prior to any study specific action.

Exclusion Criteria:

* Extensive cataract or severe corneal scaring that would affect image quality
* Fixation problems, nystagmus
* pregnancy- for women in reproductive age a pregnancy test will be performed.
Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

The overall aim of this study is to determine modifications to Exposure and Response Prevention (ERP) therapy that are needed in order to effectively deliver treatment for Obsessive Compulsive Disorder (OCD) in a community mental health center. This study is the final study in a series of three projects executed to adapt and pilot-test a team ERP (T-ERP) intervention that will optimize therapist time by utilizing paraprofessionals to assist with group-ERP treatment plans. The intervention will be tailored to meet the unique needs of low-SES individuals with OCD and be implemented in a community mental health center (CMHC).


Eligibility Criteria:
Inclusion Criteria:

1. 18 Years to 65 Years
2. English speaking
3. Primary DSM-IV OCD (identified by the patient and therapist as the most problematic disorder over the past year)
4. At least moderate severity OCD (YBOCS \> 16)
5. Not currently on psychotropic medications or on the same psychotropic medications for at least 4 weeks prior to screening
6. Have never received 10 or more sessions of ERP
7. Not currently attending psychotherapy for OCD
8. Low-income based on the U.S. Housing and Urban Development (HUDs) threshold for RI (less than $41,000 per year for individuals).

Exclusion Criteria:

1. Significant cognitive impairment (MMSE \< 25)
2. Prominent suicidal ideation
3. Current psychosis, mania, alcohol or drug dependence as assessed by the SCID-P.
4. Prominent Hoarding
Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy

We designed a monocenter prospective cohort study using PROM via app and remote monitoring via pho-toplethysmography (PPG). The application of these technologies enables an early detection of infections and therefore initiation of medical interventions. The study is conducted as feasibility analysis; primary endpoints are adherence (according to wearing time) and technical robustness.


Eligibility Criteria:
Inclusion Criteria:

* gynecological cancer
* indication for systemic cancer therapy
* patients who are legally competent and able to understand and follow instructions of the study staff
* present informed consent

Exclusion Criteria:

* no use if internet or applications
* persons who are in a dependency or employment relationship with the study center
* positive proof of COVID-19
* affection of the external auditory canal
Evolution of the Quality of Life of Short Statured Children Treated with Growth Hormone : Evaluation At Adult Size

Short stature can lead to emotional and social stress in children and adolescents, as well as their parents. Children and their parents want to be able to identify the cause of stunted growth and address it with treatment. Mitigating the impact of short stature on quality of life is one of the main goals of treatment. The quality of life in children can be measured using adapted self-questionnaires.

The investigative team published in 2019 the results of a preliminary study which shows that after one year of treatment with growth hormone, the quality of life improves in children, in particular on the scales emotional and social. These evaluations were carried out in particular thanks to the general questionnaire of quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0, but also via a specific questionnaire of the size: Quality of Life of Short Stature Youth questionnaire (QoLiSSY).

50 of the 74 patients who participated in this study have now reached their final height. The objective of the present study is to reassess this cohort using the QoLiSSY and PedsQL 4.0 questionnaires. The patient will be his own witness.

Short stature can lead to emotional and social stress in children and adolescents, as well as their parents. Children and their parents want to be able to identify the cause of stunted growth and address it with treatment. Mitigating the impact of short stature on quality of life is one of the main goals of treatment. The quality of life in children can be measured using adapted self-questionnaires.

The investigative team published in 2019 the results of a preliminary study which shows that after one year of treatment with growth hormone, the quality of life improves in children, in particular on the scales emotional and social. These evaluations were carried out in particular thanks to the general questionnaire of quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0, but also via a specific questionnaire of the size: Quality of Life of Short Stature Youth questionnaire (QoLiSSY).

50 of the 74 patients who participated in this study have now reached their final height. The objective of the present study is to reassess this cohort using the QoLiSSY and PedsQL 4.0 questionnaires. The patient will be his own witness.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults followed or having been followed by the endocrinology, gynecology and pediatric diabetology department of the Necker Enfants Malades hospital and treated with growth hormone because of their short stature.
* Patient who participated in the initial study.
* Patient having reached the final height during the last consultation (growth rate less than 1 cm / year and / or bone age ≥ 15 years for girls, ≥ 17 years for boys).
* Holders of parental authority, minor patients and adult patients informed and not opposed to their participation in the study.

Exclusion Criteria:

- Refusal to participate in the study.
Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock

Through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (HCB) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock).

HCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome.

The investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.

Vasoplegic shock is defined by arterial hypotension, a high cardiac output with a normal or high cardiac index, collapsed systemic vascular resistance (SVR) and high dose of norepinephrine in the absence of hypovolaemia. The drop in secondary organ perfusion pressure ultimately leads to multiple organ failure and death.

Through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (HCB) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock).

HCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome.

The investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.

Eligibility Criteria:
Inclusion Criteria:

* All SVR patients over 18 years of age who had received a dose of HCB since January 1 2019 will be included.

Exclusion Criteria:

* Patients who received treatment for another indication were not included.