cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis

This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol；
2. Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
3. Have atopic dermatitis at the time of screening (according to the 2014 American College of Dermatology Guidelines) and have a course of at least 1 year before screening;
4. At the screening and baseline periods, EASI ≥ 16, IGA ≥3, BSA ≥ 10 %
5. The average daily peak pruritus (itch) numerical evaluation scale (P-NRS) score for the first 7 days of randomization ≥4 points (at least 4 days of daily peak pruritus P-NRS scores need to be collected);
6. According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening

Exclusion Criteria:

1. Pregnant or lactating women
2. Major surgeries are planned for the duration of the study
3. History of previous atopic corneal conjunctivitis involving the cornea
4. History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis.
5. Subjects have had or are currently clinically significant diseases or abnormalities
6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening
7. The drug has been used in the previous 6 months
8. Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma)
9. Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation
10. Any cause that the researchers believe would prevent the participants from participating in the study
The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery

To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery

Subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. Blood sample from CVC were obtained to assess NSE preoperative. After induction, cooling helmet with circulating cold water were placed on patients group A and without circulating cold water on group B. Blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess NSE postoperative. Delirium was assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU)

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing their first open heart surgery using cardiopulmonary bypass
* Age ≥18 year-old
* Patient with American Society of Anesthesiologists (ASA) III
* Patient with Glasgow Coma Scale (GCS) 15, fully aware and oriented
* Patient fluent in Indonesia

Exclusion Criteria:

* Patients did not give consent to participate in the study
* Patients with central nervous system disease (stroke, intracranial tumor)
* Patients with psychiatric problem (schizophrenia, depression)
* Patients with cognitive problem
* Blind and deaf patient
* Patient on psychotrophic or narcotics medication

Drop out criteria

* Surgery without cardiopulmonary bypass
* Patient demise after surgery
* Patients decided to refrain from the study
Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis

Dry needling is a new treatment technique, addressed to mechanical pain of the neuromusculoskeletal system. Recent investigations has developed new hypothesis about the etiology of the osteoarthritis and could be in relation to musculoskeletal disorders, but there is no published studies evaluating the results of this technique in hip osteoarthritis patients.

The objective of this trial is to evaluate if dry needling is more effective in symptoms, function, range of motion, strength, muscular length, pain threshold and compared to sham dry needling and control.

For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of hip osteoarthritis Grade I-III by Scale of Kellgren and Lawrence.

Patients included are randomized into 3 groups one receive Dry needling, other sham dry needling and the other is a control. Groups receive 3 treatment sessions.

The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session. Patients who participated in sham dry needling or control group, when the intervention finish the investigators will be given the opportunity to receive the actual technique.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed medically with a X-Ray test
* American College of Rheumatology Criteria

Exclusion Criteria:

* Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
* Vascular or neurological disease.
* Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
* Grade IV in Kellgren and Laurence Scale
* Fear of needles
The Effect of Stabilization Exercises After Radiofrequency Lumbar Facet Denervation

A gap of knowledge exists on the understanding of the acute effects of stabilization exercises on pain, disability and physical performance when applied after radiofrequency denervation. Therefore, the main objective of this study is to show the effects of stabilization exercises when started in acute period and also reduce the frequency of recurrence low back pain of patients with FJS after radiofrequency denervation.

Lumbar facet joint syndrome has been described as a potential cause of low back pain and affects an estimated 4% to 8% of those low back pain patients without neurological deficits or radiographic evidence of lumbar spine disease. The levels of physical performance and functional disability of the patients with lumbar FJS are affected because of the chronicity of the pain.

Radiofrequency denervation (RFD) is one of the therapautic procedures are used most commonly in treatment of facet joint syndrome. Numerous placebo-controlled trials have examined lumbar facet pain and demonstrated that RFD yields positive results in lumbar pain in properly selected patients. The lumbar stabilization exercise is based on the control of the local muscle system (multifidus, transversus abdominis, diaphragm and pelvic floor muscles) responsible for ensuring segmental stability of the vertebral colon in recent years.

In the clinical trials, stabilization exercises have been shown to reduce pain, improves physical performance and prevent the recurrent low back pain by strengthing of muscles supporting the vertebral colon.

Therefore, the main objective of this study is to show the effects of stabilization exercises when started in acute period and also reduce the frequency of recurrence low back pain of patients with FJS after radiofrequency denervation.

Eligibility Criteria:
Inclusion Criteria:

* age older than 45 year, failure to improve with conservative treatment, limited functions and daily life, pain exacerbated by rest, sitting or standing

Exclusion Criteria:

* previous surgical intervention in the spine or hip, previous local injection to the lumbar spine facet joint, current treatment with a narcotic drug, impairment of cognition or speech
Retrospective Comparative in Vitro Case-controlled Study of the Liquid Biopsy Test System in Women With Breast Cancer

Proof of Concept retrospective study. Women who have the diagnosis Breast Cancer ( confirmed by biopsy) will donate a blood samples. Tubes with blood will be transferred to the Sponsors Laboratory and ARNA Breast Test will be performed. The result of test will be compared with the biopsy result for each person.


Eligibility Criteria:
Inclusion Criteria:

* Availability of signed and dated informed consent.
* Women from 35 to 65 years old, who are generally healthy, with confirmed breast cancer. Or without any neoplasms in breast (control group)
* Presence of a documented biopsy
* Presence of mammography, ultrasound or MRI of the mammary glands no later than three months.

Exclusion Criteria:

* Pregnancy.
* Any other cancers diagnosed now or previously, with the exception of breast cancer.
* Therapy with cytostatic during the last three months.
* Chemotherapy within the past three months.
* Therapy with hormonal drugs, including all forms of contraceptive drugs.
* Therapy with other prohibited groups of drugs.
* Systolic blood pressure \> 180 mm Hg. and / or diastolic blood pressure \> 120 mm Hg. with repeated measurements.
* Simultaneous participation in another clinical study.
* Relative affiliation to the clinic, for example, the patient is a close relative of the researcher or a dependent person (for example, a clinic employee or student or a sponsor employee).
* A clinically significant condition or laboratory result that, in the opinion of the investigator, threatens the safety of the test subject, may interfere with assessments, or prevent the completion of the study.
* Failure to cooperate to participate in planned procedures, including the following examples: lack of understanding of language, mental illness, inability to visit the clinic.
* Diseases or conditions that may affect the conduct of the study or the interpretation of the results.
* History of organ transplantation.
* Blood transfusions within the last 6 months.
Parasitic Ulcer Treatment Trial

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups:

* Group 1: Topical corticosteroid
* Group 2: Topical placebo


Eligibility Criteria:
Inclusion Criteria:

* AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy
* Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation

Exclusion Criteria:

* Evidence or history of interstitial keratitis
* Known herpetic keratitis, as determined from history, exam, or microbiological testing
* Known fungal keratitis, as demonstrated from corneal scrapings
* Corneal perforation or impending corneal perforation
* Prior therapeutic keratoplasty for acanthamoeba keratitis
* Unwillingness or inability to follow-up
* No light perception in the affected eye
* Known hypertensive response to steroids
* Corticosteroid allergy
* Concurrent treatment with systemic corticosteroids
* Concurrent granulomatous amoebic encephalitis
A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis

This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients \< 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Children/juveniles, 2-17 years of age.
* Polyarticular-course juvenile idiopathic arthritis (pcJIA) ≥ 6 months duration.
* Active disease (≥ 5 active joints, ≥ 3 with limitation of motion).
* Inadequate response to or inability to tolerate methotrexate.
* Methotrexate, oral corticosteroids, and non-steroidal anti-inflammatory drugs (NSAID) at stable dose(at least 8, 4, and 2 weeks,respectively) prior to baseline.
* Biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending on biologic.

Exclusion Criteria:

* Auto-immune, rheumatic disease or overlap syndrome other than pcJIA.
* Wheelchair bound or bedridden.
* Intra-articular, intramuscular, intravenous, or long-acting corticosteroids within 4 weeks prior to baseline.
* Disease-modifying anti-rheumatic drugs (DMARD) (other than methotrexate) within 4 weeks prior to baseline.
* Previous treatment with tocilizumab.
Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens

Eligibility Criteria:
Inclusion Criteria:

* Patient must be ≥18 and ≤90 years of age
* Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
* Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection

Exclusion Criteria:

* Patient has an APACHE II score \>30 (cIAI patients only)
* Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
* Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised
* Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.
Pulmonary Embolism Prognosis Model

The purpose of this study is to analyze the clinical manifestations, imaging features, and prognosis-related factors of pulmonary embolism, and to explore the prognosis risk assessment model for Chinese patients

Patients with pulmonary embolism and aged 18 years or older were enrolled in this study.Patient demographic characteristics((age, sex, department, diagnosis, ), basic vital signs, symptoms at their admissions (hemoptysis, dyspnea, chest pain, syncope), laboratory examinations (blood lab routines, blood gas, liver and kidney function, myocardial marker), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT, CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were collected by reviewing the cases. The prognostic information was collected by telephone follow-up. The follow-up end point was June 2024.

Eligibility Criteria:
Inclusion Criteria:

Aged 18 years or older. Discharged with the diagnosis of PE from Peking Union Medical College Hospital.

Exclusion Criteria:

Diagnosed PE by other health care facility or transferred from other health care facility .

Without important follow-up data.
Systematic Prevention of Further Fractures in Patients With Hip Fractures and Osteoporosis.

The purpose of this study is to determine if prevention of further fractures is possible through systematic evaluation for osteoporosis in patients with recent hip fracture

Osteoporosis is a common disease characterized by an increased risk of fracture. Furthermore recent studies has revealed that patients with fractures have increased risk of renewed fracture. Most fractures in the elderly are partly attributable to osteoporosis. The most severe of these shown to be the hip fracture (HFx) which increase mortality and decrease health related quality of life and has major impact on the level of national health service. Solid evidence is available showing several interventions to reduce the risk of osteoporotic fractures. In spite of this only few HFx patients are offered examination or treatment for osteoporosis and very rare this happens on a routine basis.

In the county of Funen and Ribe in Denmark the departments of Endocrinology and Orthopedic Surgery at Odense University Hospital and Hospital of South Western Jutland therefore initiated a fracture discharge program as part of a health technology assessment (HTA) study offering evaluation for osteoporosis to HFx patients. Evaluation consists of Duel Energy X-ray Absorptiometry, Instant Vertebral Assessment, a biochemical panel, and clinical assessment followed by specific anti-osteoporotic treatment as appropriate.

The HTA study is designed as a longitudinal cohort study of patients admitted to the participating departments with a low energy HFx. Inclusion started January first 2005 and ends December 31. 2006. After the last inclusion the follow up of the last patient are set to 2 years. In the study period data will be collected on subsequent fractures, epidemiological and demographic factors, questionnaires on quality of life, and register data on mortality, use of medication, and use of health services. The control group consists of patients admitted to any other hospital in the two participating counties who are not given this systematic evaluation for osteoporosis on a routine basis.

The HTA report will provide data to suggest if a systematic offer of evaluation and treatment of osteoporosis in HFx patients:

can reduce further fractures is accepted by the majority of patients can increase the amount of life years by decreasing mortality can increase quality of life by reducing the amount of fractures is cost effective for the health care providers

Eligibility Criteria:
Inclusion Criteria:

* admitted to the department of orthopedic surgery at Odense University Hospital or Hospital of South Western Jutland with a low energy hip fracture

Exclusion Criteria:

* dementia
* pathological fracture
* severe comorbidity
* not wanting to participate
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to healthy subjects


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Pulsed Electromagnetic Fields in Preventing Physical Deconditioning in Patients Undergoing Prolonged Hospitalization

The goal of this clinical trial is to examine if pulsed electromagnetic fields (PEMF) can prevent or decrease physical deconditioning associated with prolonged hospitalisation and immobility of haematology patients. The main question\[s\] it aims to answer \[is/are\]:

* Does haematology patients undergoing prolonged hospitalisation have no or decreased physical deconditioning when exposed to PEMF?
* What are the changes in muscle secretome at baseline and after exposure to PEMF? Researchers will compare haematology patients who receive PEMF against patients who did not receive the treatment to see if there is a change in physical deconditioning. Healthy volunteers will also be recruited and randomized to either exposure to PEMF or no exposure.

Haematology patients will

* Have their blood taken at baseline, 4 weeks from baseline and 8 weeks from baseline.
* Undergo SPPB test at baseline, 4 weeks and 8 weeks from baseline, and the test comprises of the time up and go test, 4 minute walk test and sit to stand test.
* Either expose to PEMF twice per week for 4 consecutive weeks or no exposure. Healthy volunteers will
* Have their blood taken at baseline, 4 weeks from baseline and 8 weeks from baseline.
* Either expose to PEMF twice per week for 4 consecutive weeks or no exposure.


Eligibility Criteria:
Inclusion Criteria:

* Haematology patients who are undergoing induction chemotherapy for acute leukemia
* Haematology patients who are undergoing haematopoietic stem cell transplant
* Have ECOG 0-24. Able to walk at baseline to participate in short physical battery test.
* For healthy volunteers, subjects have to be healthy without any major disease states, not on any drugs or requiring long term medical attention.

Exclusion Criteria:

* Patients who do not agree to sign the consent form.
* Pregnant women will be excluded from the study for healthy volunteers
NAT2 in Re-challenge of INH in Patients With Hepatitis

Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.

adjusting INH dose according to NAT2 genotyping and serum concentration of INH.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years-old
* Taken INH for more than 1 week
* Abnormal liver function

Exclusion criteria:

* Rule out the INH induced liver abnormality
* Existing reasons to cause liver abnormality other than TB-medication
* Taking drugs which interact with INH