cyrilzakka/clinical-trials huggingface dataset:
Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage

Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been recommended by some international guidelines . So far, there are no recent studies comparing cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6 hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not inferior to 400µg regimen), costs reductions and lower side effects may be issued without losing quality of cervix dilatation.

Miscarriage is defined by the World Health Organization as the interruption of the pregnancy up to 20-23 weeks, or the products of pregnancy weighing less than 500 grams (1). Nearly 15% of known pregnancies end in miscarriage, especially in the first 12 weeks. Estimates indicate that 68000 women die worldwide each year, as a result of unsafe abortions. Abortions are the major cause of maternal death, particularly in Latin America and the Caribbean. In cases of retained and incomplete abortions, uterine emptying is recommended. In the first trimester of pregnancy, either pharmacological or surgical procedure is accepted according to international guidelines.

Pharmacological treatment for uterine evacuation includes the administration of mifepristone and misoprostol or misoprostol alone. Nevertheless, surgical methods have been shown a greater acceptability and patient satisfaction due to a reduced incidence of adverse effects. Currently, Manual Vacuum Aspiration (MVA) is the technique recommended by the Brazilian Ministry of Health and the Brazilian Federation of Gynecology and Obstetrics.

MVA should be performed after cervical ripening. This pre-surgical procedure makes the procedure safer and more effective. In Brazil, misoprostol is the most suitable drug to be used in these cases because of its efficacy, ease of use, low cost, stability at room temperature, and availability. Misoprostol is a synthetic prostaglandin E1 analog and can be administered by oral, sublingual, buccal, rectal, and vaginal routes.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted at the Gynecological emergency Unit at Hospital de Clínicas de Porto Alegre scheduled for uterine evacuation with \<12 weeks of gestation.

Exclusion Criteria:

* patients who do not wish to participate in the project;
* patients with ectopic pregnancy;
* patients with comorbidities (heart failure congestive, chronic obstructive pulmonary disease);
* patients with hypovolemic shock;
* patients with cervical incompetence;
* patients with infected miscarriage/abortion (presence of fever, pus from the cervix, leukocytosis \[\> 14000\]);
* patients with twin pregnancy;
* patients with Marfan syndrome;
* patients allergic to misoprostol;
* patients with coagulopathy;
* patients with opening of cervical internal os (4 mm of dilatation at the time of consultation);
* patients with previous surgery of the cervix (conization);
* patients with concomitant use of IUDs.
Observational Study of Venus P-Valve

Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).

All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required.

Post-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.

Eligibility Criteria:
Inclusion Criteria

1. Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention.
2. The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.

Exclusion Criteria:

1. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol.
PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant

The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ® - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Agree to all the purposes of the study by signing and dating the Informed Consent;
* Male, aged between 20 and 55 years, clinically healthy;
* BMI between 18.5 and 30;
* Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
* VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.
* Human serum ferritin between 36-262 mcg / L;
* Counting of reticulocytes in peripheral blood ≤ 3%;
* Serum erythropoietin \< 30 mIU / mL.

Exclusion Criteria:

* Participation in clinical trials in the 12 months preceding the survey;
* Body weight \> 100 kg;
* Presence of iron deficiency anemia;
* Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
* Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
* Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
* Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study;
* Administration of any drug in the 02 weeks prior to the start of the practical period of the study;
* Clinical history of autoimmune or hereditary anemia;
* Clinical history of chronic bleeding;
* Clinical history of acute bleeding in the 30 days preceding the beginning of practical phase of the study (administration of the drug);
* Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation;
* Current or previous history (less than 12 months) of illicit drug abuse and / or tobacco and / or alcohol or having consumed alcohol within 48 hours prior to the practical study periods (administration of the drug);
* Prior therapies with erythropoietin;
* Albumin below 3.5 g/dL or higher than 4.8 g/dL;
* Signs or clinical history of bone marrow aplasia;
* History and clinical or laboratory liver disease;
* History and clinical or laboratory nephropathy;
* Principal Investigator of the study criteria.
MRI and Muscle Involvement in Patients With Mutations in GMPPB

Limb girdle muscular dystrophies (LGMD) are a very heterogeneous group of muscle disorders characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into more than 31 different types.

A new type - type 2T has been found. The genetic cause of type 2T is mutations in Guanosine Diphosphate (GDP)-mannose pyrophosphorylase B (GMPPB). Mutations in GMPPB can also cause Congenital muscular dystrophies (CMD). Only 41 patients with mutations in GMPPB has been reported.

In this study, the investigators examine five new cases with the LGMD phenotype. The primary aim is to examine the muscle involvement using MRI.


Eligibility Criteria:
Inclusion Criteria:

* Persons with genetically verified mutations in GMPPB

Exclusion Criteria:

* All contraindications for undergoing an MRI scan
Aesthetic Restorations in Deciduous Anterior Teeth

This study proposes to conduct a randomized clinical trial (RCT), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified ICDAS C+ score, with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins; and another group with monochromatic resin with chameleon effect and polyvinyl crowns.


Eligibility Criteria:
Inclusion Criteria:

* Children ranging in age from 12 to 60 months with at least one active cavitated caries lesion involving more than 2 surfaces (C+ score) in deciduous upper incisors will be included.

Exclusion Criteria:

* Patients with special needs, with general health conditions that may affect the oral cavity, whose guardians do not sign the Inform Consent Form will be excluded. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula near the tooth and teeth with previous restorations; less than 2/3 of root (radiographically assessed), teeth without an antagonist, teeth with previous restorations and children with bruxism and/or deep bite.
Optimal Approach for Analysis of Case-Control Genetic Association Studies

The purpose of this study is to examine the effectiveness of approaches to correct for the effects of population stratification on case-control genetic association studies.

BACKGROUND:

In racially admixed populations, genetic associations may be confounded by population stratification. To control for population stratification, statistical methods that use marker genotype data to infer population structure have been proposed as an alternative to family-based tests of association. However, there are limited empirical data on how these methods perform in real populations. This study will use well characterized populations of Mexican and Puerto Rican asthmatics, their parents, and control subjects recruited from the same sites to examine the effectiveness of approaches to correct for the effects of population stratification on case-control genetic association studies.

DESIGN NARRATIVE:

This study has three specific aims: 1) To test and compare methods of detecting and correcting for population stratification, the study will genotype a total of 100 ancestral informative markers (AIMs) for 400 asthma cases and an equal number of control subjects. These AIMs will then be used with three statistical methods developed to detect and correct for population stratification. The number and characteristics of markers required to correct false positive associations between AIMs, asthma, and asthma quantitative traits will be evaluated and compared; 2) To compare the power of genomically adjusted case-control studies to the Transmission Disequilibrium Test (TDT). An allele from each of the 100 AIMs will be considered as a risk factor for a simulated "phenotype." The association between phenotypes and each AIM will be tested with the TDT and with a case-control analysis after adjustment for stratification to compare the false negative rates for these study designs. 3) To use the results from aim 1 and 2 to define an optimal approach for analysis and interpretation of case-control association studies in these populations and apply this approach to analyze the association between asthma and a series of candidate genes. The results of these studies should provide important insights into optimal methods to control for population stratification in case-control association studies, thereby facilitating the inclusion of admixed populations in future genetic studies of complex diseases such as asthma.

Eligibility Criteria:
No eligibility criteria; this study will be using existing blood samples of Mexican and Puerto Rican asthmatics, their parents, and control participants who were recruited prior to the study.
Clinical Study for AL-CM

In this study, patients diagnosed with Al-CM were selected to observe the effect of treatment and conduct long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-90 years, regardless of gender, diagnosed with Al-CM at the Second Affiliated Hospital of Zhejiang University School of Medicine;
* Patients have the ability to understand the test, can cooperate with investigators.

Exclusion Criteria:

* Unable to understand or unwilling to fill in informed consent forms or follow visitors
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016

This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and it's effect on the body in Japanese male subjects.


Eligibility Criteria:
Inclusion:

1. Men, aged 20 to 45 years inclusive at screening.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg
3. Healthy as determined by the investigator on the basis of screening evaluations.
4. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion:

1. No presence or history of any disorder that may prevent the successful completion of the study.
2. No history of drug abuse within 1 year.
University Hospital of Ioannina COVID-19 (Coronavirus Disease 2019) Registry

COVID-19 (Coronavirus Disease 2019) Registry of University Hospital of Ioannina. Retrospective datasource registry with quantitative and qualitative patient data from the hospital medical records. Epidemiological, clinical and laboratory parameters are recorded on 7 different time points (day: 1, 3, 5, 7, 9, 11, 15) concerning 793 variables of interest in an electronic (computerised) database. Patients are also followed-up after 90 days from hospital discharge (number of visits of follow-up depends on patient's health status) at the Post-COVID and Long-term effects of coronavirus (long COVID) outpatient clinic of University Hospital of Ioannina. Data from this outpatient clinic are also recorded in an electronic database (189 variables of concern for each patient)

This is a retrospective study of COVID-19 (Coronavirus Disease 2019) at the Infectious Diseases Unit of the University Hospital of Ioannina. Quantitative and qualitative patient data are collected from the hospital medical records. Epidemiological, clinical and laboratory parameters are recorded on 7 different time points (day: 1, 3, 5, 7, 9, 11, 15) concerning 793 variables of interest in an electronic (computerised) database. Patients are also followed-up after 90 days from hospital discharge (number of visits of follow-up depends on patient's health status) at the Post-COVID and Long-term effects of coronavirus (long COVID) outpatient clinic of University Hospital of Ioannina. Data from this outpatient clinic are also recorded in an electronic database (189 variables of concern for each patient) The investigators collect data from COVID-19 hospitalized patients in the Infectious Diseases Unit of the University Hospital of Ioannina, from March 1st 2020 and ongoing. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection was diagnosed by reverse real time transcription-polymerase chain reaction (RT-PCR) test performed on nasopharyngeal swab specimens. Data are obtained retrospectively using patients' medical records (hard copy and digital records). All medical records are imported in a digital database anonymously with a personal identifier code for each patient, as prespecified by study protocol.

All data are collected following the highest standards set by the respective European Guidelines for Good Clinical and Laboratory Practice in Research Studies/Protocols and in accordance with the Helsinki Declaration. All participants in the study receive a personal identifier code and are kept anonymous. The epidemiological, clinical and laboratory data are collected and stored without being linked to personal data of the patients, but only to the personal identifier code. Biological samples are not collected. The collected clinical and laboratory data are archived in electronic databases (793 variables of concern for each individual patient).

Eligibility Criteria:
Inclusion Criteria:

* PCR positive for SARS-CoV-2
* hospitalization for COVID-19 disease in the Infectious Diseases Unit of University Hospital of Ioannina, greece

Exclusion Criteria:

* none
A Study for Collecting Data on the Motion Analysis of Stroke Patients

An observational study to collect (functional evaluation and daily motion) for composing 3D kinematic data that will be the basis for setting rehabilitation goal points for each stroke patient and developing virtual reality rehabilitation contents via video shooting.


Eligibility Criteria:
1. Inclusion criteria

1. Over 20 years of age
2. More than 1 month after onset of stroke
3. After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions

2. Exclusion criteria

1. Patients who correspond to one or more of the following cannot participate in the study.
2. Patients with systemic infectious symptoms at the time of participation in the study
3. In the case of a person with impaired ability to consent (less than 10 points on the MMSE), a person without a guardian
4. Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
5. Other cases where the researcher judges that participation in this study is not suitable (Patients who are participating in other studies or have participated in other studies within the past 30 days can also participate in this study.)
White Adipose Tissue in Pregnancy Study

This study aims to understand the role of metabolic tissues in the changes of the metabolism of pregnant women and whether this contributes to some women developing metabolic diseases of pregnancy such as gestational diabetes (GDM) or intrahepatic cholestasis of pregnancy (ICP). Samples of adipose tissue will be taken when pregnant women are having caesarean section or laparoscopic procedures.

There is a gradual change in metabolism in pregnancy. This is characterised by a switch from normal levels of cholesterol, glucose and bile acids in early pregnancy to high levels of lipids, glucose and bile acids in late pregnancy. This is important to ensure that nutrients are provided for the growing fetus. However, it results in some women developing metabolic diseases of pregnancy, e.g. gestational diabetes mellitus (GDM) or intrahepatic cholestasis of pregnancy (ICP).

This project aims to understand the role of metabolic tissues in the changes of the metabolism of pregnant women. The investigators are asking for permission to collect samples of adipose tissue (subcutaneous and visceral fat) when women are having surgical procedures. Specifically, the investigators would like to take small samples of fat at two time points:

1. When having a caesarean section (3rd trimester of pregnancy)
2. When having laparoscopic surgery for ectopic pregnancy (1st trimester of pregnancy) Samples will only be taken from women having surgery as part of their clinical care. The investigators are requesting permission to collect samples from women with metabolic diseases of pregnancy (GDM and ICP) and matched controls (women with uncomplicated pregnancy). The investigators will also want to collect blood samples.

There is evidence from non-pregnant individuals (and from animal studies) that the adipose tissue in different parts of the body function in different ways. Subcutaneous fat is typically a fat storage tissue while visceral adipose tissue plays a role in metabolism of fat. The investigators' studies in mice suggest that these different fat stores function differently in pregnancy, and they may play a role in the metabolic changes that cause dyslipidaemia and susceptibility to diabetes mellitus. The investigators aim to identify where there are similar changes in function of adipose tissue in human pregnancy, and whether this contributes to the development of GDM and ICP.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18-50 years of age
* Uncomplicated pregnancies
* Pathological pregnancies such as Type II Diabetes and ICP

Exclusion Criteria:

* Women treated with immunosuppressive agents, e.g. azathioprine.
* Type 1 diabetes mellitus.
* Long-standing treatment with glucocorticoids, e.g. prednisolone
* Hepatitis C, hepatitis B or HIV.
* Women unable to give consent.
Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence

GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in postmenopausal women. Urinary incontinence and pelvic floor disorders are major health problems for women, especially as they age. Pelvic floor muscle relaxation has been found to correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and lower urinary tract are crucial for supporting the pelvic organs and micturition; however, damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass and strength, lack of oral bioavailability and known potential risks have limited their use. Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower urinary tract disorders, as both testosterone and its more potent metabolite, dihydrotestosterone, have anabolic effects on muscle.


Eligibility Criteria:
Key Inclusion Criteria:

* SUI symptoms of at least 6 months duration
* Predominant SUI as determined at the Screening Visit using the Medical, Epidemiological, and Social Aspects of Aging (MESA) urinary questionnaire.
* 24-Hour pad weight \> 3 g during the screening period
* A minimum of 1 and no more than 15 SUI episodes on any single day AND no fewer than 9 total SUI episodes over 3 days during the screening period
* Positive bladder stress test conducted during the Screening Visit

Key Exclusion Criteria:

* History of pelvic radiation treatment
* History of urethral diverticula
* History of urethral sling or anterior prolapse repair
* Treatment with urethral bulking agents and/or other SUI procedure or surgery within the 6 months prior to the Screening Visit
* Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities
* Urinary incontinence of neurogenic etiology
* Morbidly obese (defined as 100 pounds over ideal body weight, or body mass index 40 or greater)
* Chronic hepatitis
* Hepatic cirrhosis
* Evidence of active infection with hepatitis B or hepatitis C
* History of human immunodeficiency virus (HIV) infection
* Subjects with a history of breast or endometrial cancer