cyrilzakka/clinical-trials huggingface dataset:
A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects

The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.

This is a randomized (study medication assigned by chance), double-blind (both the physician and subject do not know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male Japanese subjects and 24 healthy male Caucasian subjects. Subjects will receive a single dose of either 200 mg or 400 mg golimumab or placebo. Subjects will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 200 mg or 400 mg golimumab, or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Have no clinically relevant abnormalities
* non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study
* Japanese subjects born in Japan, outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents, determined by subject's verbal report
* Japanese subjects must have a valid Japanese passport
* Caucasian subjects must have Caucasian parents.

Exclusion Criteria:

* Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Have any underlying physical or psychological medical condition
* Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
A Study of Romiplostim for the Treatment of Refractory Transfusion-dependent NSAA

Efficacy and safety of Romiplostim in the treatment of refractory transfusion-dependent NSAA.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, male or female.
2. Diagnosis consistent with refractory transfusion dependence NSAA defines refractory as patients who have failed to respond to at least 6 months of prior first-line treatment with adequate doses of cyclosporine (3-5 mg/kg) and who have been treated with an adequate dose of at least one povidone for 3 months. Definition of transfusion dependence: at least 1 component transfusion on average every 8 weeks and duration of transfusion dependence ≥ 4 months.
3. Satisfy at least one of the following conditions at the time of enrolment: haemoglobin \<90 g/L, platelets \<30×10\^9/L, neutrophils \<1.0×10\^9/L.
4. Agree to sign the consent form.
5. An Eastern Cooperative Oncology Group (ECOG) score of 0-2.

Exclusion Criteria:

1. Other causes of whole blood cytopenia, such as myelodysplastic syndromes (MDS).
2. Presence of cytogenetic evidence of clonal haematological bone marrow disorders (MDS, AML).
3. PNH clones ≥50%.
4. Haematopoietic stem cell transplantation (HSCT) prior to enrolment.
5. Prior treatment with ATG.
6. Infection or haemorrhage uncontrolled by standard therapy.
7. Allergy to roprostin.
8. Active HIV, HCV or HBV infection or cirrhosis or portal hypertension.
9. Any concomitant malignancy, localised basal cell carcinoma of the skin within 5 years.
10. Liver and renal function at baseline that is more than two times normal.
11. Active infection.
12. Past history of thromboembolic events, heart attack or stroke (including antiphospholipid antibody syndrome) and current use of anticoagulants.
13. Pregnant or lactating (breastfeeding) women.
14. Participation in another clinical trial within 3 months.
Laparoscopic Approach in Adhesive Intestinal Obstruction

A Clinical trail to evaluate the efficacy of Laparoscopic approach in Adhesive Intestinal Obstruction .

There was a rapid growth of minimally invasive operations. Through its peritoneal tissue sparing character and minimal blood loss, laparoscopy was soon claimed to reduce adhesion formation and associated complications.

The aim of this prospective clinical trial study is to evaluate the use of laparoscopy in management of clinically diagnosed adhesive intestinal obstruction and the criteria of selection to get the best results .

Eligibility Criteria:
Inclusion Criteria:

* Patient who clinically diagnosed as adhesive intestinal obstruction.
* Both sexes
* Adult patients (above 18 years old

Exclusion Criteria:

* • Patient refused to participate in this study.

  * Patients not fit for laparoscopic surgery.
Characterization of Eyes With Diabetic Macular Edema That Show Different Treatment Response to Intravitreal Anti-VEGF (CHARTRES)

The purpose of this study is to identify Diabetic Macular Edema (DME) characteristics in eyes that show different response to treatment with anti-VEGF (vascular endothelial growth factor) injections of Lucentis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with 40 years of age or older.
* Type 2 Diabetes Mellitus.
* Glycosylated hemoglobin (HbA1C) ≤ 12% at screening visit.
* Presence of clinically significant DME involving the center (fovea) diagnosed in at least one eye that is eligible for anti-VEGF treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at screening visit, will be selected as the study eye.
* Visual impairment due to DME with BCVA ≥ 39 letters and ≤ 73 letters (≥ 20/160 and ≤ 20/40).
* Central subfield thickness ≥ 300µm.

Exclusion Criteria:

* Presence of any other ocular disease than DME in the study eye that may confound study results, such as Proliferative Retinopathy.
* Previous treatment with vitrectomy or intravitreous injections of triancinolone or anti-VEGF drugs in the study eye.
* Any previous laser photocoagulation (panretinal or focal) in the study eye within 6 months prior to inclusion in this study.
* Active intraocular inflammation (grade trace or above) in either eye at screening visit.
* Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at screening visit.
* Important refractive errors (myopia \> 6D) or opacification of clear media that interferes with images evaluation.
* Patients with renal failure or other systemic conditions which, in the opinion of the investigator, would preclude schedule study visits, completion of the study or a safe administration of study medication.
* Other criteria that in the opinion of the investigator should condition the evaluation purposed.
The Effectiveness of Telerehabilitation in Improving Upper Extremity in Parkinson's Patients

Parkinson's Disease (PD) is a disease that affects the functional skills of the upper extremity with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily life activities of the patients. Task-oriented training (TOT) is a highly individualized, client-centered, occupational therapy, functional-based intervention compatible with motor learning and motor control principles such as intensive motor training, variable practice, and intermittent feedback. Few studies have been found on the TOT of the upper extremity in PD. Telerehabilitation of Parkinson's patients shows many strengths, such as cost-related and time-dependent ease, and the possibility of telecommunication with clinicians. In addition, the refinement of digital health solutions with the goal to offer a patient-tailored intervention remains an ongoing process. There are a limited number of studies on TOT and telerehabilitation of the upper extremity in PD. In addition, no studies have been found applying TOT through telerehabilitation. For this purpose, a study including TOT-based telerehabilitation in upper extremity education in PD was planned.

This study is a randomized controlled study. The patients will be randomly divided into two groups as exercise and control. Balance and walking exercises consisting of 3 days a week for 6 weeks will be given to both groups as a home program. In addition, the exercise group will receive TOT-based telerehabilitation via video conferencing 3 days a week for 6 weeks. TOT will be formed from daily life activities such as reaching out, grasping, writing, and manual skills, which are frequently used in daily life. As the outcome measures, disease severity and disability, finger and hand function, hand strength, and quality of life will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 45- 70 years of age
* Having diagnosed with "Parkinson's Disease" by a specialist physician
* Having between 1-3 stages according to the Hoehn and Yahr Scale
* Mini-Mental Test score more than or equal 24

Exclusion Criteria:

- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results
A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).

IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment, restores immune function and activates a coordinated immune response against the tumor. IRX-2 is a complex proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors.

The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant (before surgery) therapy, and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
* No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care.
* Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent.
* Life Expectancy of greater than 6 months

Exclusion Criteria:

* Stage IVB Squamous Cell Carcinoma
* Use of any investigational agent within the previous 30 days
* Uncontrolled cardiovascular disease
* Myocardial infarction within the last 3 months
* Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts
* Positive for hepatitis B or C or HIV
* Evidence of distant metastases
* Clinical gastritis or peptic ulcer within the last 6 months
* Stroke within the last six months
Empowerment-based Complementary and Alternative Medicine (ECAM)

This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among patients with diabetes.

The objectives of this phase study are to (1) implement the ECAM educational app to empower patients with diabetes in their management of diabetes alongside CAM use; (2) examine the impact of the ECAM educational app on patient empowerment, CAM health literacy, risk management of CAM use, CAM communication and diabetes quality of life in patients with diabetes; and (3) collect feedback from both patients and nurses on how to improve the ECAM educational app for dissemination and implementation.

Eligibility Criteria:
Inclusion Criteria:

* People over the age of 20
* diagnosis of diabetes at least 12 months before the interview; and
* The use of CAM at least 3 months
* Sufficient mental ability to understand the informed consent form and sign it.

Exclusion Criteria:

* Participants will be excluded by an assistant researcher if they serious physical condition and hard of hearing and seeing.
Study of Fazirsiran (TAK-999, ARO-AAT) in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD)

The purpose of this study is to evaluate the the safety and efficacy of the investigational product, fazirsiran (TAK-999, ARO-AAT), administered subcutaneously to patients with alpha-1 antitrypsin deficiency associated liver disease (AATD).

Participants will be enrolled to receive multiple subcutaneous injections of fazirsiran (TAK-999, ARO-AAT). All eligible participants will require a pre-dose biopsy completed as part of the study within the screening window. All participants will undergo an end of study (EOS) biopsy. Treated participants will be offered the opportunity to continue treatment in an open label extension during which they will undergo a final biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AATD
* Liver biopsy indicating Metavir F1-F3 liver fibrosis based on local pathology read.
* Women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements
* Non-smoker for at least 1 year
* No abnormal finding of clinical relevance at screening

Exclusion Criteria:

* Clinically significant health concerns other than AATD
* Previous diagnosis or diagnosis at Screening of definitive liver cirrhosis
* Regular use of alcohol within one month prior to Screening
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study involving therapeutic intervention
* Use of illicit drugs within 1 year prior to Screening

Note: additional inclusion/exclusion criteria may apply, per protocol
Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia

To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.

According to the results of nonclinical study of humanized Meplazumab for Injection, a single dose will be used for the treatment. The treatment plan is first dose on the first day (0d) and second dose on the second day (1D) of the treatment period by intravenous(IV) infusion, each dose 10mg; The third dose will be given within 3-5 days after the second dose according to the patient's 2019-nCoV nucleic acid load, clinical manifestations and the overall evaluation of doctors, dose is 10mg. 30 mg of methylprednisolone will be given intravenously 30 minutes before each administration. Each subject will be evaluated the therapeutic effect within 28 days after the first administration, and to determine the preliminary therapeutic effect, safety and tolerability of humanized Meplazumab for Injection.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 75 years (inclusive)
* In line with the new coronavirus infection pneumonia diagnosis and treatment plan (trial version 4) issued by the Health Commission, patients with new coronavirus (2019 ncov) pneumonia were clinically diagnosed;
* The subjects must be able to understand the study and willing to participate in the study, and sign the informed consent (if the subjects with no behavioral ability think it is in their own interests to participate in the test, they should sign the informed consent by their legal guardian, or notify the consent by phone (recording) and explain it in the original medical record and other relevant documents).

Exclusion Criteria:

* Known or expected to have allergic reactions or a history of allergy to any of the ingredients treated in this trial;
* In the judgment of the investigator, there are other reasons that the patient is not suitable to participate in this study.
Genes Causing Ebstein's Anomaly

This study will investigate Ebstein's anomaly, a congenital abnormality of the tricuspid valve of the heart and try to identify the genetic origins of the disease.

Adults and children 2 years of age and older with Ebstein's anomaly and healthy volunteers may be eligible for this study. Participants undergo the following procedures:

* Blood tests: Three tube of blood will be collected, with the total amount limited to about half a teaspon for each two pounds of body weight.
* Saliva sample collection: A small amount of saliva is collected by spitting into a sterile container.
* Oral (cheek) swab: Cells are collected from the mouth using a soft brush to swab the inside lining of the cheek.
* Electrocardiogram: The electrical activity of the heart is recorded using electrodes placed on the chest.
* Echocardiogram: Heart function is assessed using ultrasound.

The goal of this study is to elucidate the genetic basis for the congenital heart disease (CHD) known as Ebstein's anomaly. These studies complement ongoing research studies using mouse models to recover mutations causing structural heart defects associated with human CHD. By elucidating the underlying genetic causes for Ebstien's anomaly, it may be possible to improve risk assessments as well as facilitate the development of new strategies for prevention and disease management. These studies are important for early diagnosis and the management of complications associated with surviving adults with Ebstein's anomaly, some of whom have undergone surgical correction and others that are unoperated.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients who have diagnosed Ebstein's anomaly or tricuspid valve disease in Belarus or Ukraine and their parents will be asked to participate in this study regardless of sex, age, or race. In addition, sex and age matched neighborhood children and their parents will be recruited as controls. There is no known ethnic or racial predilection for Ebstein's anomaly or tricuspid valve disease.

EXCLUSION CRITERIA:

There are no exclusion criteria. This may allow us to discover previously unknown relationships between Ebstein's anomaly and other diseases.
Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).

An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection.

The study duration will be 28 days, which includes 4 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18-65 years).
* Mild infection by SARS-CoV-2 detected by PCR or Antigen.
* Onset of COVID-19 symptoms up to 5 days before the day of inclusion
* Without hospitalization or oxygen supplementation on the day of inclusion.
* Signed written informed consent

Exclusion Criteria:

* Serious SARS-CoV-2 infection requiring hospitalization or oxygen supply
* Chronic diseases under regular medication (eg asthma, allergic rhinitis ...)
* Congenital or acquired immunodeficiency
* Body Mass Index (BMI)\> 30
* Coagulation disorders
* Short bowel syndrome or any surgery on the gastrointestinal tract.
* Metabolic disorders (diabetes, etc.).
* Heart failure and cardiac medical history
* Pregnant women.
* HIV positive.
* Immunocompromised
* History of significant gastrointestinal diseases
* Use of other probiotics during the last month.
* Uncertainty about the willingness or ability of the participant to comply with the requirements of the protocol.
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B

This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Treatment with Pegasys according to label and standard clinical practice
* HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis
* Serum alanine aminotransferase (ALT) \> upper limit of normal (ULN) but \</= 10 x ULN
* Hepatitis B Virus (HBV) DNA \>/= 2000 IU/mL

Exclusion Criteria:

* Contraindications to Pegasys as detailed in the label
* Co-infection with hepatitis A, hepatitis C or HIV
* Pregnant or lactating women
* Participants should not receive concomitant therapy with telbivudine
Investigation of Muscle Activity Pattern of Gluteus Medius and Tensor Fascia Lata in Patients With PFPS

The purpose of this study is to investigate the muscle activity of gluteus medius and tensor fascia lata in health control group and patients with PFPS during submaximal isometric muscle contraction.The research question :Is there any difference of muscle activity of gluteus medius and tensor fascia lata between health control group and patients with PFPS during submaximal isometric muscle contraction ？Null hypothesis:There is no difference of muscle activity of gluteus medius and tensor fascia lata between health control group and patients with PFPS during submaximal isometric muscle contraction.

Basic data

- Name, age, sex, BW, BH, pain VAS scale（VAS-activity）, affected side, dominate leg, symptom duration, activity level

Measurement

* Flexibility of iliotibial band：Ober test
* EMG data collection during 8s submaximal muscle contraction
* Muscle strength measurement of hip abductors

Eligibility Criteria:
Inclusion Criteria:

* 20-50 years old
* Insidious onset of symptoms
* Pain exist at least 3 month, VAS activity\>4
* Two of the following activities induce pain at anterior or retropatellar site prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping
* Diagnosed by an orthopedic surgeon

Exclusion Criteria:

* History of lower extremity fracture or operation
* Neurological disease involved
* Observed knee deformity
* Other well-defined musculoskeletal problems in lower extremity
Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis

Primary localized hyperhidrosis is a dermatological disorder that involves excessive sweat production without an underlying cause. The disease usually affects the axillae but can also involve palms, soles of the feet or face and causes major problems in many social situations with a negative impact on quality of life and mental health.

In this study, the investigators want to investigate the effect of microwave therapy (MiraDry®) on self-rated sweating, quality of life and anxiety in participants with severe axillary hyperhidrosis. The study also aims to evaluate the safety (side effects) of the method and long term effects over 1 year of follow upp.

The study is conducted during several visits or telephone follow-ups at the clinic over a period of 12 months and each patient receives a maximum of two treatments with MiraDry® (at 3-month intervals). 100 participants are planned to participate in the study.

The primary objective is to evaluate the effectiveness of the miraDry ® treatment measured by Hyperhidrosis Disease Severity Scale(HDSS).

Secondary objectives are to evaluate the side effects and the quality of Life by assessment of The Dermatology life Quality Index, The Hyperhidrosis Quality of Life Index, and Hospital Anxiety and Depression Scale.

Eligibility Criteria:
Inclusion Criteria:

* This study will recruit participants diagnosed with primarily axillary hyperhidrosis
* Informed consent is required.
* HDSS 3 or 4 (the criteria used in Sweden to allow hospital-based intervention).

Exclusion Criteria:

Participants

* who are unable to provide informed consent,
* have known allergies to lidocaine, chlorhexidine, and/or epinephrine,
* are pregnant,
* are unable to take oral antibiotics or antiseptic washes,
* have heart pacemakers or other electronic device implants,
* who need supplemental oxygen,
* have had axillary surgery procedures for hyperhidrosis,
* with previous hidradenitis suppurativa or other local infections
* had previous cancer in the treated area are not eligible to participate in this study