cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE

The investigators propose a study to evaluate the safety, local tolerability, convenience, and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary angioedema. The investigators believe that self administration with Icatibant for treatment of an acute attack of angioedema will not change the time to complete or near complete resolution of symptoms compared to treatment with Icatibant in a medical facility.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females at least 18 years of age at the time of informed consent
2. Documented diagnosis of hereditary angioedema Type I or II based on ALL of the following criteria:

   * Family and/or medical history
   * Characteristic attack manifestations, recurrent attacks
   * Historical low C4, normal C1q and either low C1-INH or low C1INH function
3. Women of childbearing potential must use consistently and correctly a highly effective, adequate method of birth control (failure rate less than 1% per year), sexual abstinence or have a vasectomised partner during the duration of the study. Hormonal contraception can be continued if verified by a physician that it doesn't affect the course of hereditary angioedema attacks.
4. Mental and physical condition allowing patients to complete baseline assessment, to self-administer Icatibant and to follow other study procedures.
5. Ability to provide signed written informed consent after all aspects of the study have been explained and discussed with the patient.

Exclusion Criteria:

1. Participation in a clinical therapeutic trial of another investigational medicinal product within the past month (except a previous Icatibant study).
2. Diagnosis of angioedema other than Type I or Type II hereditary angioedema.
3. Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.
4. Congestive heart failure (NYHA Class 3 and 4).
5. Stroke within the past 6 months.
6. Treatment with angiotensin converting enzyme inhibitor.
7. Pregnancy and/or breast-feeding.
8. In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
9. In the opinion of the investigator: unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason.
10. In the opinion of the investigator: inability to complete the patient diary, manage study medication or self-administration of an injection.
A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)

The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab subcutaneous (SC) injections. The secondary objectives of this study are to estimate the proportion of participants detected with ANAs when switched from natalizumab intravenous (IV) to natalizumab SC (natalizumab-experienced cohort); to evaluate serious adverse events (SAEs), including injection reactions and hypersensitivity reactions, by ANA status and to assess the proportion of participants who had MS relapse, by ANA status.

The study will collect data prospectively and retrospectively.

Eligibility Criteria:
Key Inclusion Criteria:

* Participants who are natalizumab-naïve and other MS mAb-naive and who start on natalizumab SC.
* Participants who have previously received natalizumab IV and switch from natalizumab IV to SC administration.

Key Exclusion Criteria :

* For the natalizumab-naive and other MS mAb-naive cohort, participants who previously received natalizumab or other MS mAbs will be excluded.
* For the natalizumab-experienced cohort, participants who are naive to natalizumab will be excluded.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori

The aim of this study is to compare the effectiveness of Vonaprazan based therapy vs.Proton Pump Inhibitor (PPI)based therapy for the eradication of H.Pylori infection in treatment naive and treatment experienced Egyptian patients.This prospective, non- randomized, controlled study was conducted on symptomatic patients admitted at Tropical Medicine Department at Ain Shams University Hospitals and those presenting at outpatient clinic. The study was conducted in the period from the 1st of January 2022 to the 1st of June 2023.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years of both genders.
* Symptomatic patients who has been diagnosed to be H. pylori positive stool by using H. pylori stool antigen test.
* Patients who did not receive H. pylori eradication regimens before were included in group I of the study (First line eradication regimen).
* Patients who received only one eradication regimen before were included in group II of the study (Second line eradication regimen).
* Patients signing an informed consent.

Exclusion Criteria:

* Patients refusing to sign an informed consent.
* Patients who were on PPIs, P-CABs and/or antibiotics starting one month before inclusion in the study .
* Patients who have chronic debilitating and advanced systemic diseases.
* Patients treated with low dose aspirin and/or non-steroidal anti-inflammatory drugs for a long time.
* Any lactating or pregnant female.
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and \< 7 years old) for Part A; from 6 to 35 months old (i.e. ≥ 6 months old and \< 36 months old) for Part B at the time of first vaccination.
2. Subject's guardians were able and willing to comply with study procedures and give written informed consent.
3. Subject was able and could comply with the requirements of the protocol.
4. Subject with body temperature ≤38°C.

Exclusion Criteria:

1. Subject with previous known exposure to Enterovirus 71 (EV71).
2. Subject with a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
3. Subject with gestation \< 37 weeks.
4. Subject with birth weight \<2.5 kg.
5. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
6. Family history of seizures or progressive neurological disease.
7. Family history of congenital or hereditary immunodeficiency.
8. Severe malnutrition or dysgenopathy.
9. Major congenital defects or serious chronic illness, including perinatal brain damage.
10. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
11. Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws.
12. Any acute infections 7 days prior to administrate the first vaccination.
13. Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
14. Administration of any attenuated live vaccine within 7 days prior to vaccination.
15. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
16. Chronic administration (defined as \> 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination.
17. Under anti-tuberculosis prevention or therapy.
18. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises in Preeclampsia

To compare the effect of Jacobson's Relaxation Techniques and stretching exercises on Preeclampsia in pregnant women.

The effectiveness of Jacobson's progressive muscle relaxation technique on maternal, fetal, and neonatal outcomes in women with non-severe preeclampsiain have been studied in an RCT study. Pregnant women who use this technique experience reduced muscle tension and a sense of calm. in one of the study The Effect of Relaxation Techniques on Blood Pressure and Stress Among Pregnant Women with Mild Pregnancy Induced Hypertension were investigated in which Women with mild pregnancy-induced hypertension who used relaxation techniques saw significant improvements in their knowledge, physiological parameters, and blood pressure as well as a reduction in stress.

To the best of the researcher's knowledge, no comparative study has been done to yet to evaluate the efficacy of relaxation and stretching exercise. There is not enough data to determine whether Jacobson's relaxation techniques and stretching exercise reduce preeclampsia in pregnant women. As a result, this study will contribute to the expanding body of knowledge about which approach should be used as an alternative if results from other procedures are comparable

Eligibility Criteria:
Inclusion Criteria:

* Gestational age was exceeding 24 weeks
* BP more than or up to 140/90
* Diagnosed with gestational Hypertension
* Primiparous

Exclusion Criteria:

* Women with history of preterm labor or repeated abortion
* Bleeding
* Intra uterine fetal growth anomalies
* Underlying mental (depression with severe anxiety)
* Cardio respiratory diseases
Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)

The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects who

* are 18 to 45 years of age, inclusive, on the day of screening;
* have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
* are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);
* agree to keep a daily record of symptoms;
* if female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Subjects who

* have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;
* have received any vaccination within 2 weeks prior to vaccination in this study;
* suffer from any kind of immunodeficiency;
* suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response;
* have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
* have received a blood transfusion or immunoglobulins within 30 days of study entry;
* have donated blood or plasma within 30 days of study entry;
* have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications);
* have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
* have a known or suspected problem with alcohol or drug abuse;
* are unable to lead an independent life as a result of either physical or mental handicap;
* were administered an investigational drug within six weeks prior to study entry;
* are concurrently participating in a clinical study that includes the administration of an investigational product;
* if female, are pregnant or lactating;
* are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
Clinical Analysis of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery

This study is conducted to evaluate its morphologic reproliferating patterns in patients with pterygium treated with the excision and conjunctival autograft.

The medical records of 116 eyes of 116 patients with pterygium who had pterygium excision and conjunctival autograft between February 2009 and May 2011 were reviewed. Using consecutively recorded photographs, we evaluated preoperative morphologic characteristics and its growth patterns.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent pterygium
* Unilateral or bilateral pterygium
* Both male and female
* Consenting to participate in study

Exclusion Criteria:

* Fibrovascular proliferation secondary to injury
* Severe dry eye syndrome
* Pseudopterygium
* Signs of malignancy on pterygium
* Corneoscleral trauma or corneo-limbal scars
Transcorneal Electrical Stimulation - Multicenter Safety Study

The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.

This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist
* adult patients who are capable of giving consent,
* Visual acuity ≥ 0.02
* because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)
* the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol

Exclusion Criteria:

* diabetic retinopathy
* neovascularisation of any origin
* after arterial or venous occlusion
* after retinal detachment
* silicone oil tamponade
* dry or exudative age-related macular degeneration
* macular edema
* all forms of glaucoma
* any form of corneal degeneration that reduces visual acuity
* systemic diseases that are difficult to control or manage, that could endanger the normal study schedule
* patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic
* forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia
* simultaneous participation in another interventional study or history of interventions whose effect may still persist
Effects of a Rehabilitation Treatment on Balance in PD Evaluated With a Stabilometric Platform

Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in Parkinson's disease, whereas previous reports of physical interventions have suggested promising results. The investigators want to study the effects of the multidisciplinary intensive rehabilitation treatment (MIRT) on balance disorders in Parkinson Disease (PD).

Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in Parkinson's disease, whereas previous reports of physical interventions have suggested promising results. The investigators want to study the effects of our multidisciplinary intensive rehabilitation treatment (MIRT) on balance disorders in PD.

PD patients in stage 3 of Hoen \& Yahr will undergo clinical and instrumental evaluations at the beginning (T0) and at the end (T1) of the MIRT. Berg Balance Scale (BBS) will be performed to assess static and dynamic balance abilities. In order to determine some variables as index of postural stability, the investigators will use a stabilometric platform. With respect to the average centre of gravity the standard deviation (SD) of trunk sway will be calculated: total, in antero-posterior (AP) and in medio-lateral (ML) direction. The investigators can obtain a statokinesigram, that is the layout of a line connecting the successive positions of the center of pressure during the recording, and the area of the ellipse containing 90% of the sampled positions of the center of pressure. These measurements will be calculated with open eyes (OE), and while the patient was performing a cognitive task (open eyes counting \[OEC\]).

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with PD in stage 3 of Hoen \& Yahr according to the United Kingdom Brain Bank criteria.

Exclusion criteria:

Atypical parkinsonisms, patients with osteoarticular and muscular pathologies, PD patients with Mini Mental State Examination \< 26, patients with other disorders of balance.
Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo

Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.

At present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis.

In this aim, two groups were compared. The first group receive 10mg/week of methotrexate administered in one shot (every Monday for example)during 12 months. The second group receive 10mg/week of placebo according to the same procedure


Eligibility Criteria:
Inclusion Criteria:

* hand arthritis
* pain over 40/100
* stable treatment since 4 weeks at least with non-steroid analgesic
* between 45 et 85 years

Exclusion Criteria:

* pregnancy or breast feeding women
* hyaluronic acid injection within the past 6 months
* cortisonic derivated injection within the past 3 months
Percutaneous Biodegradable Biliary Stents for the Treatment of Benign Biliary Strictures.

To assess safety and effectiveness in the long term of percutaneous insertion of Biodegradable (BD) Biliary Stents for the treatment of benign biliary strictures, in a single center experience.

This is an observational study (retrospective analysis on a prospective database) of patients that have been implanted a biodegradable stent in the biliary tree to treat benign stenosis.

From march 2011 until May 2020, a prospective collection of clinical data has been conducted in patients with symptomatic benign biliary strictures treated biodegradable polydioxanone stents. A strict follow-up protocol has been carried out according to standard practice (at 2, 4, 6 months and every 6 months up to 5 years). Once the follow-up is completed, the collected data will be analyzed, assessing the long term effectiveness and safety, but also other variables related to stent implantation and impact on patient's quality of life.

A subgroup analysis of anastomotic biliary strictures will be performed.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years old attended in the interventional radiology department for the implantation of a biodegradable biliary stent (BBS: ELLA-CS, Hradec Kralove, Czech Republic), for each stenosis, by percutaneous technique.
* Written informed consent given

Exclusion Criteria:

* Patients under 18 years old
* Patients with post-liver transplant biliary strictures
* Patients for whom no post-intervention follow-up data are available
* Patients in whom malignancy is demonstrated as a cause of the stricture after stent placement.
Psychiatric Problems in Children and Adolescents Infected With HIV at Birth

The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health problems or make mental health problems worse in children and adolescents who were infected with HIV at birth.

Research has shown that HIV is able to penetrate the blood-brain barrier and may significantly affect the central nervous system (CNS). Although the effects of HIV on the CNS are not fully understood, there is growing evidence that the effects are psychosocial in nature; HIV infected children experience higher rates of psychiatric symptoms and hospitalizations than their uninfected counterparts. Confounding the HIV CNS relationship is evidence suggesting that the CNS effects of HIV may also be related to antiretroviral treatment. This study will examine the rates and severity of psychiatric symptoms in both HIV infected and uninfected children and adolescents. In addition, this study will determine the relationship between duration of antiretroviral treatment and psychiatric symptoms.

No treatment will be given as part of this study. The study will last for 96 weeks and be divided into two parts. In Part 1, HIV infected and uninfected participants and their caregivers will complete a series of measures and questionnaires regarding mental health, pain, and adherence to treatment. In Part 2, all participants and their caregivers will complete a subset of the original measures at Weeks 48 and 96. This follow-up part of the study will assess any long-term changes in psychiatric symptoms. In addition, a subset of HIV infected and uninfected participants and their caregivers will take part in psychiatric interviews at specified study sites. A portion of these interviews will be audio-taped.

Eligibility Criteria:
Inclusion Criteria for HIV Infected Participants:

* Acquired HIV through mother-to-child transmission

Inclusion Criteria for HIV Uninfected Participants:

* HIV uninfected

Inclusion Criteria for All Participants:

* Living with same parent or primary caregiver for at least 12 months prior to study screening
* Willing and able to provide consent or assent

Exclusion Criteria for HIV Infected Participants:

* Acquired HIV through adult high-risk behavior, blood transfusion, or abuse

Exclusion Criteria for All Participants:

* IQ of 69 or lower, for participants whose primary language is English. More information on this criterion can be found in the protocol.