cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant

This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in subjects with different degrees of hepatic impairment to the PK of a single-dose of tozadenant in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

All subjects must fulfill the following to participate:

* Subject has given his/her written informed consent on an IEC or IRB approved consent form.
* Subject understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.
* Be either male or female 18 years old
* Have a BMI ≥ 18.5 and ≤ 40.0 kg/m2 at screening
* Is a continuous non-smoker or a smoker who will consume up to 10 cigarettes/day
* Child bearing females should be sexually inactive (abstinent) prior to dosing
* Females subjects of non childbearing potential must have undergone one of the following sterilization or be postmenopausal

Subjects with mild, moderate, or severe hepatic impairment must:

* Have a medical history consistent with a diagnosis of hepatic impairment.
* Have a diagnosis of chronic (\> 6 months), stable hepatic insufficiency

Healthy subjects must be:

* Medically healthy with no significant medical history

Exclusion Criteria:

Subjects must not be enrolled in the study if they:

* Previously participated in any study with tozadenant
* Has orthostatic hypotension, history or symptoms of cardiovascular disease, or hypertensive crisis.
* Currently participating in or has participated in another study and received drug (active or placebo)
* Have a known diagnosis of malignant melanoma
* Have a current episode of major depression
* Has a recent history of suicide attempt
* Has any other condition or clinically significant abnormal findings on the physical or neurological examination, psychiatric and medical history
* Had surgery or any medical condition within 6 months
* Unable to refrain from or anticipates the use of any drugs, vitamins, natural or herbal supplements
* Subject is currently lactating or pregnant or planning to become pregnant.
* Recent donation of blood, plasma or significant blood loss
* Has positive test for ethanol or drugs of abuse or a history of chronic alcohol or drug abuse
* Clinically significant medical history
* Positive results hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) for Healthy Volunteers only.
Efficacy of Riluzole in Hereditary Cerebellar Ataxia

The hereditary cerebellar ataxias include diverse neurodegenerative disorders. Hereditary ataxias can be divided into autosomal dominant ataxias (ADCAs), autosomal recessive ataxias (ARCAs), X-linked, and mitochondrial ataxias on the basis of mode of inheritance. The key feature in all these disorders is ataxia typically characterised by poor balance, hand incoordination, postural or kinetic tremor, dysarthria and dysphagia.

To date no treatment has been shown to slow progression of the disease and symptomatic therapies are limited to few options that are partially effective.

Purkinje cells project inhibitory signals to the deep cerebellar nuclei(DCN) which have a critical role in cerebellar function and motor performance. DCN neurons fire spontaneously in the absence of synaptic input from Purkinje neurons and modulation of the DCN response by Purkinje input is believed to be responsible for coordination of movement, while uncontrolled spontaneous firing of DCN neurons may underlay cerebellar ataxia. Recent studies have demonstrated that small-conductance calcium-activated potassium (SK) channels inhibitor are able to increase DCN firing rate. Since SK channels are critical regulators of DCN firing rate, SK openers such as the drug riluzole may reduce neuronal hyperexcitability and thereby be useful in the therapy of cerebellar ataxia.

On this base the investigators published a pilot study in patients with chronic cerebellar ataxia (Ristori et al., Neurology 2010) investigating safety and efficacy of riluzole or placebo administration for 8 weeks. The results demonstrated a significative improvement in International Cooperative Ataxia Rating Scale (ICARS) global score after four weeks and after 8 weeks in the riluzole arm.

The present protocol is aimed at verifying the safety and efficacy of riluzole administration for a longer period, in a larger sample size of patients, with more stringent diagnostic criteria (hereditary cerebellar ataxia), respect to the above pilot study. Sixty patients will be enrolled in a double-blind, placebo-controlled trial. By central randomisation, patients will take 50 mg of riluzole or placebo twice daily for 12 months. Treatment effects will be assessed by comparing the Scale for the Assessment and Rating of Ataxia (SARA) before treatment and during therapy at months 3 and 12.


Eligibility Criteria:
Inclusion Criteria:

* Patients with genetically confirmed diagnosis of hereditary cerebellar ataxia

Exclusion Criteria:

* Concomitant experimental therapy for ataxia
* Serious systemic illnesses
* Pregnancy
To Evaluate Safety, Tolerability and Pharmacokinetics of GRC 27864 in Healthy Subjects and Elderly Healthy Subjects

This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, aged ≥18 to \<55 years (\> 65 years for elderly cohort) at the time of informed consent
2. Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be \>50 kg
3. Subjects who are healthy and free from clinically significant illness or disease
4. Females must be of non-childbearing potential, surgically sterile.
5. Male subjects whose partners are of childbearing potential or have undergone tubal ligation must agree to use 2 highly effective methods of contraception

Exclusion Criteria:

1. Systolic blood pressure (SBP) \<90 mmHg or \>140 mmHg, diastolic blood pressure (DBP) \<45 mmHg or \>90 mmHg, resting pulse rate \<40 beats per minute (bpm) or \>100 bpm
2. Subjects who have the presence of active peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, chronic diarrhoea or positive 13C urea breath/faecal test for Helicobacter pylori at Screening.
3. Subjects with inherited or acquired disorders of platelet function, bleeding or coagulation.
4. Presence of any clinically relevant acute or chronic disease that could interfere with the subject's safety during the clinical study, expose the subject to undue risk.
Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children

This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. A total of 25 children will be recruited.

As myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. In a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children.

This clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. Without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. The study population includes 25 children subjects in Singapore, aged 6 to 8 years during the commencement of the treatment. The axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form.
* Equal to or greater than 6 years and less than 9 years at time of informed consent and assent.
* Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
* Astigmatism, if present, of not more than 1.50 D.
* Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
* Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
* Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
* Absence of strabismus by cover test at near or distance wearing correction.
* Absence of amblyopia
* Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.

Exclusion Criteria:

* Vulnerability of subject
* History of myopia control intervention
* Participation in any clinical study within 30 days of the Baseline visit.
A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer

The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients is little known. This study would recruit 400 Chinese EOC patients with known targeted gene mutations via a multi-panel testing of 27 genes, including BRCA1/BRCA2. All patients accept evaluation of HRD model, which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Pathological confirmation of epithelial ovarian cancer
* With available tumor tissues
* Given consents to participate the study

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Assessment of Primary Care Providers' Knowledge and Beliefs Regarding Gout Management

This is a questionnaire study aimed at learning about physicians' views on the treatment of Gout.

We seek to assess the knowledge, beliefs and reported treatment practices of primary care physicians with regard to gout.

Specifically, we will:

* Assess the knowledge and beliefs with regard to acute and chronic gout management based on published treatment recommendations.
* Characterize the individuals who have knowledge deficits in terms of age, specialty, number of patients seen with gout, and practice setting.
* Assess the reported treatment practices of primary care physicians for the acute and chronic management of gout.

Eligibility Criteria:
Inclusion Criteria:

* practicing primary care practitioner, either in family medicine or internal medicine,
* must be 18 years of age or older

Exclusion Criteria:

* does not meet inclusion criteria
Severe Women Injury Factors Test (SWIFT)

Intimate partner violence is a real public health problem, and affects all socio-cultural backgrounds It is defined by behavior within an intimate relationship that causes physical, psychological or sexual harm or suffering to the people in that relationship.

Several risk factors exist such as young age, low level of education, exposing to violence during childhood, pregnancy or addictions.

Routine screening is recommended with redaction of medical certificate in which doctor have to determine l'"Incapacité Totale de Travail" corresponding to the duration of discomfort (physical and psychological repercussions) in the activities of daily life.

It is a legal notion allows to rule on the responsibility of the author. The sentence is increased if the ITT is greater than 8 days.

Worldwide, 30% of women suffered violence whose most common form is intimate partner violence, but legal proceedings have been initiated in less than 25% of the cases.

The trauma of women victims of domestic violence worsens with the repetitions of assaults.

The investigators suppose that the duration of ITT is an indicator of the severity of the injuries sustained.

So, the investigators want to highlight the socio-demographic characteristics and describe the spouse abuse, and then related theese factors to " Incapacité Totale de Travail " (term used in law. It is a scale for assessing the importance of injuries).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Admission to emergency for intimate partner violence
* Or consultation to SOS doctor for intimate partner violence
* Or consultation to medico-judicial unit for intimate partner violence
* No verbal opposition to inclusion

Exclusion Criteria:

* Non intimate partner violence
* Patient under guardianship or curatorship
* Non French speaker
* Coma or inability to express non-opposition
* Prior participation in another center
Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease

The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303 in subjects with Crohn's disease.

This is a Phase I, open-label, non-randomised, multicenter single-dose study to evaluate PK, PD, and safety of a single oral dose of MT-1303 in subjects with moderate to severe active Crohn's disease (ileal and ileo-colonic type).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were diagnosed as Crohn's disease
* Subjects who were confirmed as ileal or ileo-colonic type by image inspection.
* Disease severity determined as either "moderate" or "severe"

Exclusion Criteria:

* Present or past history of gastrointestinal surgery which may have impact on drug absorption
* Subjects with stenosis or fistula in small intestine or colon
From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1

This study aims to investigate synaptic physiology and behavioral inhibition in patients with NF1 and ASD and to answer whether inhibitory deficits at these levels are modulated by lovastatin.

Structure: (1) Visit 1: Baseline assessment- participant's characterization, baseline outcome measures and additional evaluations, (2) 3 consecutive days of physiologically probing drug/placebo intake, (3) Visit 2: Outcome measures and additional evaluations in the day after the last drug/placebo intake, (4) Washout period of 4 to 6 weeks, (5) 3 consecutive days of drug/placebo intake, (6) Visit 3: Outcome measures and additional evaluations in the day after the last placebo/drug intake.

The literature has shown synaptic inhibitory dysfunction in both ASD and NF1. Here the investigators aim to test whether a mechanistic link can be established between that synaptic inhibitory dysfunction, systems levels changes in oscillatory synchrony and regulation of inhibition and treatment with Lovastatin in these two neurodevelopmental disorders. The investigators will explore this link through the application of complementary quantitative measures (putative biomarkers), such as magnetic resonance spectroscopy (MRS) transcranial magnetic stimulation (TMS) and electroencephalogram (EEG) applied to the same group of adult patients before and after the lovastatin or placebo intake during three days.

The intervention comprehends three sessions: the first two visits will occur in the same week and the third visit will take place 4 to 6 weeks later. In the first visit (baseline assessment), participants will perform neuropsychological, EEG, MRS and TMS assessment. In the other two visits participants will repeat EEG, MRS and TMS assessments to study possible post- intervention effects. Participants will intake 60mg of Lovastatin or Placebo during three consecutive days before the second and the third visits.

Eligibility Criteria:
Inclusion Criteria:

* Positive diagnostic results for ASD in:

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

* Positive diagnostic results for NF1:

Clinical diagnosis based on the well-established clinical criteria

Exclusion Criteria:

* Global Intelligence Quotient \< 80
* Associated medical condition such as epilepsy, neurologic conditions, genetic syndromes, or other usual comorbidity in ASD and NF1 populations
* Medication capable of interfering with the intervention and/or study results
* Pregnancy
* Drug use and/or alcohol abuse
* Contra-indications to MR and TMS
Feasibility Bowel Dysfunction Program After Low Anterior Resection

This study will facilitate a better understanding of the overall experience of our rectal cancer survivors after Low Anterior Resection for rectal cancer. Studies have demonstrated that the development of bowel and genitourinary dysfunction after this procedure is very distressing to patients and can have a significant impact on overall quality of life. By providing interventions that can be performed at home, investigator may alleviate these symptoms in hopes of improving the experience of patients undergoing Low Anterior Resection. By acknowledging these potentially debilitating symptoms in a systematic way, the investigator hopes to reinforce the importance of symptom management in the survivorship phase after treatment has been completed and ultimately facilitate an individual's return to routine activities.

Subjects will be recruited from patients presenting to the surgical oncology clinic at Fox Chase Cancer Center. These patients will have already undergone Low Anterior Resection with a diverting stoma (colostomy or ileostomy) and will be planning on undergoing reversal of their stoma in the near future. Subjects will be recruited over a period of 1 year. Such clinic patients' medical records will be reviewed to determine whether they are possible candidates for inclusion in the study. They will be identified based on their diagnosis of either Stage II or III rectal cancer as stated in prior clinic notes, pathology reports, or radiologic image reports. Participants must have previously undergone Low Anterior Resection with a diverting stoma and the surgical plan must be for them to undergo ostomy reversal. They will be approached during a clinic visit by either a co-investigator or a member of the surgery team (fellow or surgeon) or a research coordinator delegate and asked to participate in the research study. They will be given a document for informed consent that will describe the study and potential risks and benefits to the patient. The investigators plan to enroll 10 patients at Fox Chase Cancer Center. Subjects will receive no monetary compensation

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Stage II or III rectal cancer, a history of having an LAR with diverting stoma, and a plan to undergo stoma reversal within the next 6 months

Exclusion Criteria:

* Patients enrolled who develop an anastomotic leak at the time of stoma reversal that would necessitate another temporary or permanent stoma, they will be considered unevaluable and will be excluded from the analysis
Haptoglobin and Diabetes Complications in Pregnancy

Pregnancies of patients with Diabetes are associated with increase adverse pregnancy outcome . The risk for vascular complications including: Intra uterine growth restriction (20%), hypertension (31%), preeclampsia (15%), eclampsia and placental abruption are significantly greater than those in background populations. The risk of developing vascular complications in diabetes pregnancies although is correlated with the severity and length of the disease is not fully understood. Enhanced oxidation has been suggested to be the underlying abnormality responsible for some of the complications of diabetes.

Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The best understood function of Hp is to bind free hemoglobin (Hb) released from red blood cells. Extracorpuscular Hb is a potent Fenton reagent.capable of of inflicting oxidative tissue damage. Hp binds to Hb and serves to inhibit the oxidative potential of Hb by preventing the release of heme iron.

The haptoglobin (Hp) gene at chromosomal locus 16q22 is polymorphic, with two common alleles denoted 1 and 2. the prevalence of Hp 1-1, Hp 1-2 and Hp 2-2 genotypes is approximately 16%, 48% and 36%, respectively. In the western world. A total of five independent longitudinal studies have demonstrated that DM individuals with Hp 2-2 genotype have a two to five-fold increased risk of CVD as compared to DM individuals without the Hp 2-2 genotype We sought to determine whether HP genotype plays important role in development of vascular complications in pregastational pregnancies. and whether Hp genotype 2-2 is a risk factor for developing gestational diabetes (GDM)


Eligibility Criteria:
Inclusion Criteria:

* Diabetes in pregnancy

Exclusion Criteria:

* Not willing to participate
Eosinophil Indices in Patients With Acute Heart Failure

All consecutive patients admitted to the intensive care unit (ICU) with ADHF between January 2017 and December 2021 were enrolled in this retrospective study. All-cause mortality and MACE were assessed with respect to relationships with eosinophil indices, including neutrophil-to-eosinophil ratio (NER), leukocyte-to-eosinophil ratio (LER), eosinophil-to-lymphocyte ratio (ELR), and eosinophil-to-monocyte ratio (EMR).

All consecutive patients admitted to the intensive care unit (ICU) with ADHF and reduced EF between January 2017 and December 2021 were enrolled in this retrospective study. HFrEF was defined as having an LVEF of ≤40%. Demographic data were retrieved from patient charts and the institutional digital database. Patients with an LVEF \>40%, NYHA Class I and II subjects, those with advanced liver, kidney diseases or malignancies, patients in whom life expectancy was extremely short and patients with autoimmune, allergic, or infectious diseases that affect the eosinophil indices were not included in the study. The study was approved by the local ethics committee.

Conventional guidelines had been followed for the in-hospital treatment of all patients with ADHF, including loop diuretics, vasodilators, inotropes/vasopressors \[9\]. Blood tests including complete blood count, blood urea nitrogen and creatinine, electrolytes, liver enzymes, and NT-pro BNP were ordered upon admission to the ICU. All patients underwent transthoracic echocardiography. LVEF was measured with 2-dimensional echocardiography via the modified Simpson method \[10\]. Data concerning 6-month all-cause mortality and MACE were retrieved from the institutional digital database. The definition of MACE was the composite of total death and re-hospitalization for HF within 6 months of initial hospitalization.

The primary outcome measure of this study was all-cause mortality within the first 6 months of index hospitalization and its relationship with eosinophil indices, including NER, LER, ELR and EMR. The secondary outcome measure of this study was the assessment of MACE within the first 6 months of index hospitalization and its association with eosinophil indices.

Eligibility Criteria:
Inclusion Criteria:

* patients who admitted to the intensive care unit (ICU) with Acute Decompensated Heart Failure and reduced Ejection Fraction (\<%40)

Exclusion Criteria:

* Patients with an LVEF \>40%, NYHA Class I and II subjects, those with advanced liver, kidney diseases or malignancies, patients in whom life expectancy was extremely short and patients with autoimmune, allergic, or infectious diseases
Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy

Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.

retrospective and prospective 150

Eligibility Criteria:
Inclusion Criteria:

retrospective:12 months at least first anti-TNF therapy prospective: at maximum 6 months observation AS patients with axial involvement

Exclusion Criteria:

patients in other AS studies involved