cyrilzakka/clinical-trials huggingface dataset:
Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension

This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, age 18 or older
* Given informed consent
* Diagnosed as having mild to moderate essential hypertension

Exclusion Criteria:

* Severe hypertension
* Significant preexisting cardiovascular and cerebrovascular disease
* Diabetes mellitus type 1 or poorly controlled diabetes mellitus type II
* Advanced renal impairment

Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients.

This study is a multi-center, open-label, extension trial to evaluate the safety, efficacy of SCT800 in long term prophylaxis and on-demand treatment in patients with severe hemophilia A who have been previously treated with coagulation factor VIII(FVIII) . This study includes two phases: the screening period and prophylaxis period.Prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered once every other day or three times per week starting from V1, on-demand treatment is given when bleeding episodes occur. The study period is 120 consecutive weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male patients who are diagnosed with severe (laboratory tested FVIII:C \<2%) hemophilia A;
* Patients Who Completed trial of SCT800-A302 or SCT800-A 303 and New PTP(previously treated patients)(Previously received FVIII prophylactic or bleeding treatment, have the relevant records and are verified to have accumulated exposures days( EDs) ≥150 days;
* Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay result \<0.6 BU(Bethesda unit)/mL);
* The treatment records of at least 50EDs before screening can be obtained;
* HIV negative; if HIV positive, the viral load \<200 particles/uL or \<400,000 copies/mL, and HIV patients must satisfy CD4+ count \>200/μL;
* The patient or his guardian voluntarily signed the Informed Consent Form.

Exclusion Criteria:

* Known allergy to any coagulation factor VIII or any excipient; known allergy to bovine, rodent or hamster bovine;
* Has a history or family history of blood coagulation factor VIII inhibitor;
* Patients with other coagulation dysfunction diseases in addition to hemophilia A;
* Patients with other clinically significant diseases, alcoholism, drug abuse, mental disorders or intellectual disabilities;
* Patients with other severe or clinical significant diseases verified by the investigator to be unable to benefit from the clinical study;
* Patients who participated in other clinical studies within one month before the first drug administration (except FVIII trials) and patients who participated in other FVIII clinical trials after signing the Informed Consent Form;
ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.

Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.

25 adult subjects with moderate to severe plaque psoriasis will receive Ilumya 100mg subcutaneously at weeks 0, 4 and 16.

At week 16, patients with remaining BSA ˃3% will be given HALOG ointment 0.1% to apply BID for 4 weeks. Patients who have ≤3% BSA at week 16 will remain on Ilumya monotherapy.

Patients will continue to be evaluated at weeks 20 and 24.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by

   * BSA 10%
   * PGA ≥3
   * PASI ≥12
3. Must be a candidate for phototherapy and/or systemic therapy
4. Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.

Exclusion Criteria:

1. Non-plaque forms of psoriasis
2. Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
3. Presence of significant uncontrolled medical condition that in the opinion of the investigator would affect patient safety during the trial.
4. Active or untreated latent tuberculosis (TB)
The Effects of Iron Treatment on Malaria and Measles Vaccine Response in Kenyan Infants with Iron Deficiency

Malaria and iron deficiency cause a significant burden of disease in Africa. Iron deficiency (ID) might affect immune responses to vaccination.

In this double-blind randomized controlled trial, we aim to assess: (1) whether ID impairs R21/Matrix-M and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.


Eligibility Criteria:
Inclusion Criteria:

* Subject's caregiver is willing and able to give informed consent
* Male or Female, 6 months (+/- 2 weeks) of age
* Mother at least ≥15 years of age
* Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) \>61 μmol/mol heme)
* With or without anemia (anemia defined by Hb \<110 g/L)

Exclusion Criteria:

* Severely anemic (Hb \<70 g/L)
* Malaria vaccination prior to enrollment
* Medical condition that precludes study involvement
* Iron supplementation 2 weeks before enrollment
* Acute or chronic infection (e.g. HIV)
* Wasted (length for height z score of ≥-2) or underweight (weight for age z score ≥-2).
Safety and Efficacy of House Dust Mite Allergoid in the Treatment of Bronchial Asthma

The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.

The rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase III clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. This condition is present in paediatric and adult patients with a shorter history of GINA II and III asthma, who were investigated in this study.

Eligibility Criteria:
Inclusion Criteria:

* Bronchial asthma
* Requirements for inhaled corticosteroid
* Positive skin prick test to house dust mite
* Positive radioallergosorbent test (RAST) to house dust mite
* Positive provocation test result to house dust mite

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies
Retrospective Study Using Next Generation Sequencing (NGS) on Biological Samples to Improve Genetic Counseling for Patients With Previously Explored Craniofacial Midline Defects.

Holoprosencephaly, or HPE, is the most common congenital cerebral malformation in humans and the most severe of a group of pathologies related to a deficiency of the SHH signalling pathway (Sonic Hedgehog SHH-D). It is characterized by severe cerebral and craniofacial abnormalities.

The regulation of SHH concentration is therefore crucial for correct craniofacial development.

Despite the recent identification of about 20 genes, 70% of cases of EHPE and craniofacial midline abnormalities of genetic origin do not have a molecular diagnosis. It is therefore important to continue the search for new candidate genes to improve the understanding of brain and facial development and to improve genetic counseling for these families.

The development of Next-Generation Sequencing (NGS) technologies opens up the possibility of studying the exome or even the genome in a single manipulation. The latter type of analysis is particularly well suited to the discovery of new genes and will therefore improve the care of patients and their families.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Craniofacial Midline Facial Anomalies (CMFLA) collected for genetic analysis
* Patients and relatives for whom consent for research-related genetic testing is available. A "trio" - patient and both parents is required for analysis of variant segregation and determination of mode of transmission.
* For patients who are minors, parental authority(ies) who have given consent for research genetic testing.
* Affiliation to a social security scheme
* Patient and parents do not object to their participation in the research.
* In the case of a patient who has reached the age of majority since the initial consent was obtained, a patient who has given consent to proceed with genetic analyses for research purposes.

Exclusion Criteria:

* adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
Erythropoietin and Pediatric Cardiac Surgery

Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury.

This randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects.

Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. A medicine already used in humans, erythropoietin, may protect the heart and brain of children born with heart defects during their surgical repair. In a rabbit model, erythropoietin did protect the hearts. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury.

For this randomized control trial, 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects, will be divided into four groups. Two groups will be children whose usual blood oxygen level is low because of their heart defect; the other two will be children with normal blood oxygen levels. Each child will be randomized to receive either erythropoietin or placebo 15 minutes prior to stopping the heart during their surgery.

Erythropoietin's protective function will be measured after surgery by: (1) amount of medication required to support heart function, (2) how well the heart pumps blood as seen by echocardiogram, (3) levels of chemicals produced by the body when heart or brain tissue injury occurs, (4) urine output and oxygen levels (5) time on ventilator support (6) ICU stay and (7) hospital stay. Heart tissue will be collected during surgery to determine how erythropoietin protects heart cells.

Statistical tests including ANOVA will test for similarities and differences among the groups on the measures of protection from injury.

Note - the study design was edited after the FDA released a warning about the use of erythropoietin. Only acyanotic patients were recruited therefore only 2 study groups are included.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 weeks to 18 years
* Requiring open heart surgery for congenital heart defect -Parents able to speak English and document informed consent -

Exclusion Criteria:

* Received erythropoietin within past 30 days
* Previous adverse reaction to erythropoietin or to albumin
* History of neurological disorder -Laboratory evidence of kidney or liver dysfunction -
Examining Genetic Factors That Affect the Severity of 22q11.2 Deletion Syndrome

22q11.2 deletion syndrome is a genetic disorder that can cause heart defects, facial abnormalities, and developmental and learning disabilities. The severity of the disorder can vary widely among people. This study will analyze DNA from people with 22q11.2 deletion syndrome to identify genetic variations that may affect the severity of the disorder.

22q11.2 deletion syndrome is a disorder caused by the deletion of a small piece of chromosome 22. Most people with this disorder are missing a sequence of about 3 million DNA building blocks on chromosome 22 within each cell. This disorder affects many areas of the body. People with 22q11.2 deletion syndrome may have heart defects, immune deficiency, kidney abnormalities, hearing loss, and cleft palate or other facial deformities. Many children experience developmental delays and learning disabilities, and they have an increased risk of developing mental illnesses, including schizophrenia, depression, anxiety, and bipolar disorder. All people with 22q11.2 deletion syndrome are missing the same sequence of DNA, but the severity of this disorder varies widely; some people are diagnosed with multiple health and developmental problems, while others experience very few symptoms. In some people, the symptoms may be so minimal that they are not even aware they have 22q11.2 deletion syndrome. This study will examine genetic material-either from blood or saliva-among people with 22q11.2 deletion syndrome. Participants will attend one study visit and undergo either blood or saliva collection. By analyzing the DNA sequences of participants, the study will aim to identify any genetic variations that may affect the severity of 22q11.2 deletion syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Has 22q11 deletion of 3 megabases (Mb)

Exclusion Criteria:

* Has 22q11 deletion smaller than 3 Mb or no deletion
Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC

The purpose of this study is to determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations.

A open, positive control of phase II clinical trials, divided into selection period, treatment period and follow-up period , comply with the standard set of participants signed a written informed consent, according to different divided into 19 patients with EGFR mutations outside show son mutation group) and 21 extra show mutations, and according to the ECOG physical status, age, previous systemic treatments such as hierarchical analysis, regular follow-up and to assess efficacy, life care and safety.

Eligibility Criteria:
Inclusion Criteria:

1. at the age of 18 -70 years old, male or female
2. the non-small cell lung cancer diagnosed by histopathology
3. detected by ARMS to confirm that the EGFR sensitive mutant patients
4. the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1)
5. have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs
6. no brain metastasis symptoms, including, increased intracranial pressure, no vomiting, ignoring the papillary edema, no headache, without hemiplegia, ignore things not clear, without epilepsy
7. PS:0 or 1
8. the expected survival time 3 months \&gt;
9. patients signed informed consent voluntarily

Exclusion Criteria:

1. 4 weeks before entering the group received operation or operation, the wound has not healed completely
2. into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine
3. serious cardiovascular diseases, including Department of internal medicine, uncontrolled hypertension, unstable angina, myocardial infarction history exists within the past June, severe arrhythmia or pericardial effusion
4. serious infection, need intravenous antibiotic, antifungal or antiviral treatment
5. before entering the group 4 weeks participated in any study drug clinical trial
6. there are serious tumor invasion, oppression by the main bronchus or bronchial stenosis or obstruction, superior vena cava syndrome
7. the existence of herniation of brain tumor apoplexy, epilepsy, and frequent
8. suffering from a mental illness, poor compliance
9. the researchers think that do not fit into the group of cases
A Study to Evaluate 608 in Patients with Non- Radiographic Axial Spondyloarthritis (nr-axSpA)

This study will evaluate the effect and safety of 608 in patients with nr-axSpA.

The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo in patients with nr-axSpA.

Eligibility Criteria:
Inclusion Criteria:

1. Female and male patients at least 18 years of age at the time of screening.
2. Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
3. Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
4. Total back pain as measured by NRS ≥ 4 at baseline

Exclusion Criteria:

1. Patients with other uncontrolled active inflammatory diseases.
2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
4. History of cancer.
5. Known or suspected history of immunosuppression.
6. Known with allergic or intolerant to mometasone furoate spray or 608/placebo.
B-cell Chronic Lymphoid Malignancies Markers

Lymphoid chronic B-cell malignancies are frequent pathologies that affect adults, with a very variable prognosis and treatment (some of them can remain untreated). The diagnosis of these malignancies relies on the study of the morphology of tumoral cells and the expression by these cells of several markers, mainly via a technical approach called flow cytometry. Because the markers currently used remain imperfect, additional ones are needed for an accurate diagnosis that affect both prognosis and treatment.

In addition, because numerous markers are used at the diagnosis, there is a need of tools that synthetize the multi-dimensional structure of the data obtained.

The primary purpose of this study is to detect new markers that can be of help for the diagnosis of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies.

The secondary purpose of this study is to obtain a statistical algorithm that allow a good prediction of the different sub-types of chronic B-cell malignancies mainly using the results of flow cytometry.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years-old with of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies
* patients that gave their informed consent for the conservation of blood or bone marrow cells (primary objective 1)
* patients that gave their informed consent for the retrospective use of their clinical and biological data

Exclusion Criteria:

* patients under guardianship or curatorship
* patients who did not gave their consent for the use of their cells and/or data
Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients

This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients under Highly Active Anti-Retroviral Therapy (HAART) or Naïve from treatment

Exclusion Criteria:

* Age limits
* Pregnancy
* Legal restrictions to consent
A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer

The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).

The study planned to enroll three cohorts with approximately 30 participants in each, including a dose-limiting toxicity (DLT) evaluation phase (the first 12 weeks of any treatment) and an expansion phase. Initially, up to 12 participants were to be enrolled into Cohort 1 in order to obtain 6 evaluable participants through the DLT evaluation period of 12 weeks. Safety data were reviewed by a Safety Monitoring Committee (SMC) for each cohort during the DLT evaluation phase before the next cohort opened. Once a new cohort was opened, the previously opened cohort was permitted to continue enrolling participants for the expansion phase for a total of 30 participants per cohort.

Only two of the planned three cohorts enrolled participants in the study based on the SMC recommendation after DLTs were identified in Cohort 2.

Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically or cytologically confirmed extensive-stage small cell lung cancer (SCLC) with progressive disease after at least one platinum-based chemotherapeutic regimen and with evaluable or measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Has active, known, or suspected autoimmune disease
* Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug
Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

To investigate the therapeutic effect of including virtual reality-based digital content in the upper limb motor function rehabilitation of stroke patients and to develop a treatment method to improve the upper limb motor function of stroke patients in the future.


Eligibility Criteria:
1. Inclusion Criteria for experimental group:

1. Patients aged 19 to 80 years with unilateral stroke within 6 months of stroke onset
2. Motor function evaluation: Patients showing moderate or lower upper limb dysfunction with an upper limb FMA (Fugl-Meyer Assessment) score of less than 58 points on the affected side.
3. Patients receiving or planning to receive exercise rehabilitation treatment 5 days a week

2. Inclusion Criteria for control group:

1) Patients who have been admitted to our hospital's rehabilitation medicine department and received rehabilitation treatment within the past 5 years 2) Patients with unilateral stroke within 6 months of stroke onset who are between 19 and 80 years old at the time of hospitalization 3) Patients who were admitted to the rehabilitation medicine department of our hospital and received exercise rehabilitation treatment for 4 weeks, 5 days a week 4) Patients with similar characteristics below compared to the test group

* Age: Difference within 5 years
* Gait function: Functional Ambulatory Category (FAC)
* Upper extremity function: Fugl-Meyer Assessment (FMA) difference within 6 points
* Cognitive function: Korean Version of Mini Mental State Examination (K-MMSE) difference within 5 points
* Daily living skills: Korean Version of Modified Barthel Index (K-MBI) difference within 10 points

  3. Exclusion Criteria:
  1. Accompanying existing serious neurogenic disease
  2. Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc.
  3. Cases where it is difficult to understand task performance due to severe cognitive decline (Korean Mini-Mental State Examination, K-MMSE 10 points or less)
  4. If there are difficulties in conducting research
  5. Other patients who are judged by the principal investigator to have difficulty participating in this study.