cyrilzakka/clinical-trials huggingface dataset:
High Quality Evidence of Chinese Lupus Nephritis (HELP)

The investigators are registering LN patients at recruited hospitals and developing a LN database in China. Patients will be follow-up every year, and both baseline and follow-up information will be entered into the registration system.

The investigators are registering Lupus nephritis (LN) and developing a LN database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education etc.), clinical characteristics (including systolic blood pressure, diastolic blood pressure, and lab measurements of whole blood, serum, urine etc.), complications, drug information at the baseline will be collected. Patients will be follow-up every year, the demographic and clinical characteristics, complications; drug information of patients will be collected at each visit. We will also record the outcome at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), end-stage renal disease (ESRD) or serum creatinine doubling. The patient survival and renal survival will be compared using the LN database.

Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnosis as lupus nephritis

Exclusion Criteria:

* No
The Effect of Hot Water Application in Pregnant Women With Restless Legs Syndrome: A Randomised Controlled Study

Backgraund and Purpose: The prevalance of restless legs syndrome (RLS) in pregnants varies between 15.4-26.0 percent. As well as pharmacological methods, there are studies reporting that non-pharmacological methods reduce RLS symptoms but the number of studies conducted with pregnants is limited. This study was conducted to determine the effect of hot water application to the legs of pregnants with RLS on their complaints.

Materials and methods: The study is a pretest-posttest randomised controlled. Among the pregnants whose IRLS score was more than 11, 13 people to the intervention group and 16 people to the control group were randomised. The data were collected using Personal Information Form, International RLS Study Group Diagnostic Criteria, and the International RLS Rating Scale (IRLS). Hot water application was made of intervention group. The application was made for 20 minutes before bedtime for seven days. No application was made in the control group other than routine care and follow-up. Chi-square test, descriptive statistics and dependent/independent samples t tests were used to assess the data. The value of p\<0.05 was accepted as significant.


Eligibility Criteria:
Inclusion Criteria:

* in the gestation age of 28-32 weeks,
* literate,
* according to RLS Diagnostic Criteria and had 11 and higher severity according to International RLS Rating Scale (IRLS)

Exclusion Criteria:

* risky pregnancies,
* communication problems,
* any chronic and psychiatric disease
* were using antipsychotic, antidepressant, antihistaminic, and antiemetic drugs,
* had history of deep vein thrombosis
Best Treatment Modality of Frozen Shoulder

This study will compare between the effect of three treatment modalities of shoulder adhesive capsulitis to hilight the best technique to improve pain and range of motion outcome measures .


Eligibility Criteria:
Inclusion Criteria:

* gross limitation of passive shoulder movement
* pain interfering with daily activities
* painful restiction of active and passive movement of shoulder

Exclusion Criteria:

* presence of degenerative pathology
* fracture
* contraindication to steroid injection
* deformity affecting upper limb
* history of previous shoulder injection in the past 4 weeks
Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).

The ULYSSES study is a single-center, prospective study aimed at evaluation of myocardial ischemia using regadenoson low-dose dynamic computed tomography myocardial perfusion imaging (CTP) in patients diagnosed with intermediate coronary artery stenoses in referrence to the magnetic resonance myocardial perfusion imaging (MR MPI).

The ULYSSES study is a single-center, prospective study aimed at evaluation of myocardial ischemia using regadenoson low-dose dynamic computed tomography myocardial perfusion (CTP) in patients diagnosed with intermediate coronary artery stenoses in referrence to the magnetic resonance myocardial perfusion imaging (MR MPI).

The main objectives of the study are:

* to evaluate feasibility of low - dose regadenoson dynamic computed tomography myocardial imaging protocol
* to assess the diagnostic value of quantitative dynamic CTP based absolute parameters (myocardial blood flow - MBF, myocardial blood volume - MBV, perfused capillary blood volume - PCBV, peak value - PV, time to peak - TTP) in reference to magnetic resonance myocardial perfusion imaging
* to assess the diagnostic value of quantitative dynamic CTP based relative parameters (relative myocardial blood flow - MBFR, relative myocardial blood volume - MBVR, relative perfused capillary blood volume - PCBVR, relative peak value - PVR, relative time to peak - TTPR) in reference to magnetic resonance myocardial perfusion imaging
* evaluation of safety of regadenoson low-dose dynamic CTP.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* signing written, informed consent by the patient for participation in the study
* patients who are asymptomatic or with symptoms of stable coronary heart disease
* intermediate coronary artery stenosis of at least one coronary artery in CTCA

Exclusion Criteria:

* the symptoms of unstable ischemic heart disease and /or myocardial infarction,
* the history of myocardial infarction
* patients with impaired renal function (GFR \<60 mL)
* contraindications for computed tomography or magnetic resonance imaging (including pregnancy, the presence of a cardiac pacemaker or cardioverter-defibrillator, claustrophobia, the presence of metal elements, etc.);
* contraindications to the administration of iodine contrast media (including allergy to contrast, unstable hyperthyroidism, etc.)
* contraindications to administration of regadenosone (hypersensitivity to the active substance, second or third degree atrioventricular block or other sinus node dysfunction, unstable angina, hypotension, decompensated heart failure, etc.);
* heart failure with impaired left ventricular systolic function
* a significant valvular heart disease
* presence of aortic aneurysm or aortic dissection
* persistent atrial fibrillation / atrial flutter
* hypertrophic cardiomyopathy
Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy

The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of a novel mesenchymal precursor cell type (iMP) in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting.

This study aims to investigates in situ cardiac regeneration utilizing precision delivery of a novel mesenchymal precursor cell type (iMP) during coronary artery bypass surgery (CABG) in patients with ischemic cardiomyopathy (LVEF \< 40 %). Preoperative scintigraphy imaging (SPECT) will be used to identify hibernating myocardium not suitable for conventional myocardial revascularization for iMP implantation. iMP cells will be implanted intramyocardially in predefined viable peri-infarct areas that show poor perfusion, which could not be grafted due to poor target vessel quality. Postoperatively, SPECT will be used to identify changes in scar area.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years
* Severe coronary artery disease amenable to surgical revascularization according to current guidelines
* History of acute myocardial infarction at least 14 days previously
* Left ventricular ejection fraction (LVEF) ≤ 40% as assessed with echocardiography
* Distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization
* Patient's informed consent obtained

Exclusion Criteria:

* Emergency operation
* Debilitating chronic disease (eg. malignancy or terminal renal failure)
* Concomitant valve surgery
* Previous cardiac surgery
* Malignant ventricular arrhythmias
* Haematologic disease
* Woman in reproductive age
* Severe psychiatric illness
A Longitudinal Examination of Unpaid Caregivers of Acquired Brain Injury (ABI) Survivors in Nova Scotia

The purpose of the present study is to follow unpaid caregivers of ABI survivors in Nova Scotia over time to learn more about their experiences. The study is funded by the Government of Nova Scotia (i.e. Department of Health and Wellness). The present longitudinal cohort study will help increase knowledge about ABI caregivers at a provincial level. Findings will also be used in developing future interventions to help caregivers in this population.

The goals of the research study are:

1. To understand the natural experiences of unpaid caregivers over time. More specifically, the investigators hope to learn about the experiences of unpaid caregivers of acquired brain injury survivors in Nova Scotia.
2. To examine the connection between study demographic variables (e.g. the amount of time spent caregiving in hours per week), and psychological outcome variables (e.g. caregiver burden).
3. To learn about the relationship between psychological outcome variables (e.g. psychological distress and savouring).
4. To provide a platform for future studies using the Trials within Cohort (TwiC) study design.

The Investigators are employing a Trials within Cohorts research design. That is, they are conducting a prospective longitudinal cohort study, with the cohort serving as a platform in which future studies or interventions can be tested. In accordance with this approach, eligible participants who have given consent to be contacted in the future may be selected and approached for future participation in randomized controlled trials.

Eligibility Criteria:
Inclusion Criteria:

* Participant is an unpaid, informal, caregiver of an ABI survivor
* Participant live in Nova Scotia
* Participant is able to read, write and understand English
* Participant has access to a tablet, smart phone, or computer with high speed internet
* Participant consents to complete online study questionnaires

Exclusion Criteria:

* Participant is a paid, professional caregiver of an ABI survivor
* Participant does not live in Nova Scotia
* Participant is not able to read, write and understand English
* Participant does not have access to a tablet, smart phone, or computer with high speed internet
* Participant does not consent to complete online study questionnaires
Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants

This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in infants receiving morphine after surgery. Codeine may be effective enough to make morphine unnecessary.


Eligibility Criteria:
Inclusion Criteria:

* Infants with cleft palate
A Study to Evaluate ALN-6400 in Adult Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria -

* Is a healthy adult volunteer

Exclusion Criteria -

* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN)
* Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
* Has an estimated glomerular filtration (eGFR) of \<90 mL/min/1.73m\^2 at screening
* Is not willing to comply with the contraceptive requirements during the study period

Note: other protocol defined inclusion / exclusion criteria apply
Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma

This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccine delivered by electroporation (EP) to participants with human papilloma virus (HPV) associated head and neck squamous cell cancer (HNSCC).

This is a Phase I/IIa, open-label, study to evaluate the safety, tolerability, and immunogenicity of INO-3112 \[6 mg of VGX-3100 (2 separate DNA plasmids respectively encoding E6 and E7 proteins of HPV 16 and HPV 18) and 1 mg of INO-9012 (DNA plasmid encoding human interleukin 12)\] delivered by electroporation (EP) in up to 25 (twenty-five) participants with HPV positive head and neck cancer. The immunotherapy was studied in the following two groups of participants:

1. Participants who received immunotherapy before and after definitive surgery (Cohort I)
2. Participants who received immunotherapy at least 2 months after chemoradiation therapy (Cohort II).

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated written Ethics Committee approved informed consent.
2. Age ≥18 years.
3. Histologically confirmed HPV-positive (as assessed by p16 IHC or oncogenic HPV ISH or PCR) mucosal squamous cell head and neck cancer:

   * For pre-surgical participants, p16 positivity must be confirmed prior to the first dose.
   * For participants post-chemoradiation, HPV 16 and HPV 18 positivity must be confirmed prior to the first dose.
4. Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 cells/mm3, hemoglobin ≥9.0 g/dL, concentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN), (Aspartate Aminotransferase) AST, (Alanine Aminotransferase) ALT within 2.5x institutional ULN, (Creatine Phosphokinase) CPK within 2.5 x ULN.
5. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.

Exclusion Criteria:

1. Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids).
2. Any concurrent condition requiring the continued use of systemic steroids (\>10 mg prednisone or equivalent per day) or the use of immunosuppressive agents. All other corticosteroids must be discontinued at least 4 weeks prior to Day 0 of treatment.
3. Administration of any vaccine within 6 weeks of enrollment.
Breast Fat Grafting Augmentation in Chinese Women

A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1 year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and well-being of patients during the preoperative and 1 year post operation.

Autologous fat was obtained from thighs, waist or abdomen using resonance liposuction instrument. Fat was injected into the tissues in a multitunnel and multilayer way until they were firm and appeared fully tumesced according to the Coleman method.All MRI volume analyses were blindly performed by examiner independently preoperatively and 1 year postoperatively. Object marking was done using avanto 1.5T superconducting magnetic resonance scanner.Volume analysis was done by counting pixels within the frames of the MRI using ImageChecker CAD software.The Chinese version of BREAST-Q augmentation module was obtained from the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. 38 patients were given the BREAST-Q questionnaire to express their thoughts preoperatively and 1 year postoperatively. Data were calculated using the Q-score program, which converts raw BREAST-Q scores of 1 through 4 or 5 to scores of 0 to 100.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women agreed to participate in the study

Exclusion Criteria:

* Patients who had breast surgery previously
* Women on the lactation or gestation period
Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL

Extracorporeal shock wave lithotripsy (ESWL) is widely used in the treatment of urinary tract stones and is generally applied to outpatients. To achieve fragmentation in ESWL, shock waves must be applied with sufficient power and time. Providing effective analgesia during this procedure is crucial to the success of the procedure. Erector Spinae Plan Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in urinary system surgery. This study aimed to investigate the efficacy of ESPB in patients undergoing ESWL.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

To evaluate the safety and immune response to 160 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation.

Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

Healthy volunteers are injected on days 0, 30, 180, and 365 with either 160 mcg gp160 vaccine (20 volunteers) or an alum placebo preparation (10 volunteers).

Eligibility Criteria:
Inclusion Criteria

Subjects must have:

* Normal history and physical exam.
* Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
* T4 count \>= 800 cells/mm3.
* Normal chest x-ray and urinalysis.
* Negative hepatitis B surface antigen.
* Negative HIV p24 antigen test.
* Normal skin reactivity by Merieux test.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

* Positive PPD.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).

Subjects with the following prior conditions are excluded:

* History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.

Prior Treatment:

Excluded:

* Prior blood transfusions or cryoprecipitates within the past 6 months.

Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:

* Any history of IV drug use.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
* More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Duloxetine Versus Placebo for Fibromyalgia

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* You are male or female outpatient at least 18 years of age with fibromyalgia. Females of child-bearing potential must test negative on a pregnancy test at visit 1.

Exclusion Criteria:

* Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition (including unstable hypertension and not clinically euthyroid) or psychological conditions that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
* Abnormal thyroid-stimulating hormone concentrations.
Orthotics and Running

To investigate whether a prefabricated Orthotic inserted into running shoes will increase comfort, decrease injury and improve speed during recreational running as compared to running shoes without the prefabricated Orthotic.

Running is the most accessible sport in the world. Data from the UK House of Commons has indicated that running has become the favourite exercise among adults 16 or older. However, as the sport grows, so too does the number of running-related injuries (RRIs).

An Orthotic is a device that is placed inside the shoe and functions as a cushion to absorb the shock transmitted on contact with the ground; in addition, they also affect muscle activation that can benefit the user. However, in contemporaneous medical literature, there are mixed views and opinions on whether the use of Orthotics reduces running-related injuries.

This is a randomised control trial that will be conducted over an 8-week period, during which participants will be asked to complete runs and provide data in the form of completed surveys. The primary objective of this study is to investigate whether a prefabricated Orthotic inserted into running shoes will increase comfort, decrease injury and improve speed during recreational running as compared to running shoes without the prefabricated Orthotic.

The study population will include 106 participants who will be randomised into the study and control group. Participants in the study group will be provided with an Orthotic and will run with this in the participants normal running shoes. Participants in the control group will not be provided with the Orthotic and will run in the participants regular running shoes.

All participants (in both groups) will be asked to provide data following each run and also once a week regarding any injury sustained in the preceding 7 days. The minimum required data set will comprise of the personal details and consent on initial enrolment, ongoing consent and data from at least 10 runs (there are 5 individual pieces of information from each run - the date of the run, the distance, the time taken, whether an Orthotic was used or not and the comfort during the run), and injury data every week during the 8 week study period.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and over.
* Used to running at least 5kms in the last 1 year.

Exclusion Criteria:

* Are currently using a prescription orthotic.
* Have any ongoing pain or deformity in the foot.
* Have been advised by a doctor to not exercise due to a serious health condition.
* Have undergone any surgery in the last 6 months.
* Have undergone any surgery on the foot during lifetime.