cyrilzakka/clinical-trials huggingface dataset:
Renal Arterial Resistive Index as a Noninvasive Biomarker of Disease Activity in Lupus Nephritis Patients

Systemic Lupus Erthymatosous (SLE) is achronic inflammatory multi system auto immue disease characterized by pathogenic auto anti bodies production against nuclear structures (Bolouri et al.,2022), SLE affecting mainly woemn of childbearing age and is chracterized by unpredictable flares and remissions , disease variety varied from mild episode disorder to arpidly progressive life -threatening illness..

LN is diagnosed by either the presence of proteinuria \>0.5g/day. active urinary sediment , or an unexplained rise in serum creatinine there fore , identifying new invasive biomarkers of LN severity and outcome is mandatory, Renal Arterial resistive index ( RRI) is anon invasive biomarker that has been studied as apotential indicator of disease activity in LN patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years.
* SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) classification criteria and matched controls.
* Patients cooperative and can answer questions.
* Patients who are able and willing to give written informed consent.

Exclusion Criteria:

* • Individuals with other autoimmune diseases.

  * Diabetes.
  * Hypertension.
  * Heart failure.
  * Hepatic diseases.
  * Chronic renal failure.
  * Renal artery stenosis.
  * Renal vein thrombosis.
  * Intrarenal arteriovenous fistula.
  * Obstructive nephropathy.
  * Urinary tract obstruction that could affect RI of intra renal arteries.
  * Un cooperative patients.
  * Patients not able and willing to give written informed consent.
Backup With Combivir or Single Dose (SD) Truvada in Order to Avoid Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Resistance After SD Nevirapine for the Prevention of Mother-to-child Transmission (PMTCT)

The aim of the study is to find short course alternatives to single dose (sd)nevirapine for the prevention of mother-to-child HIV-transmission with the same or better degree of transmission protection than sd nevirapine but with less NNRTI resistance development.

Randomised open study comparing Zidovudine from 28 weeks gestation, single dose Nevirapine + 1 week of Combivir with Zidovudine from 28 weeks gestation, single dose Nevirapine + single dose of Truvada for the mothers during birth. In both arms the infants will receive one dose of nevirapine within the first days after births as well as 7 to 28 days Zidovudine. N = 450. The study will be conducted at Ngamiani and Makorora Health Centres and Bombo Regional Hospital in Tanga, Tanzania as a cooperation between Rigshospitalet, Denmark, University of Copenhagen and National Institute of Medical Research, Tanzania.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected, antiretroviral naive, not fulfilling national Tanzanian criteria for HAART treatment, giving informed consent, consenting to homevisit-follow-up in case of no-show for scheduled hospital visit.

Exclusion Criteria:

* CD4 less than 350 x10(6)/L, suffering from systemic diseases in need of medical treatment e.g. TB, renal or liver failure etc.
* Creatinin higher than 1,5 mg/dL, Alanine aminotransferase above 140 U/L
Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors

The purpose of this study is to evaluate the clinical safety and efficacies of cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed solid tumors including GI/lung/cervical cancers

KOC1, TTK, CO16(URLC10), DEPDC1, MPHOSPH1 have been identified using genome-wide expression profile analysis by the use of cDNA microarray in the previous studies. The investigators have determined the HLA-A\*2402 restricted epitope peptides respectively derived from KOC1, TTK, CO16(URLC10), DEPDC1, and MPHOSPH1 showed strong INF-gamma production when stimulated with the appropriate targets expressing the appropriate protein and HLA-A\*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore the investigators focused on the prevention of further expansion of the solid tumors highly expressing these 5 proteins using these 5 peptides.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of unresectable or relapsed gastrointestinal, lung or cervical cancer patients
* performance status 0-1
* age between 20 and 80
* at least 4 weeks after previous therapy
* life expectancy more than 3 months
* permissible bone marrow, liver and renal function
* HLA-A2402
* no viral hepatitis, HIV or HTLV1

Exclusion Criteria:

* severe underlying disease
* pregnant or lactating women
* active brain metastasis
* uncontrollable infection
* under systemic corticosteroid or immune suppressant treatment
* history of allergy to epitope peptides or IFA
Promoting Resilience in Women with Breast Cancer

The PRISM (Promoting Resilience in Stress Management) intervention is an evidence-based program that builds resilience. This program was developed in adolescent and young adult oncology and utilizes centrally administered skills-based coaching to bolster positive psychological tools known as resilience resources. These resources include stress management, goal-setting, and positive reframing. Previous studies using this intervention have found PRISM to be successfully administered remotely and it has improved resilience, psychological distress, hope, and quality of life. Among adult caregivers, PRISM has shown to improve resilience, self-efficacy, and engagement with medical care. While PRISM successfully targets distress and associated downstream consequences known to be experienced by breast cancer survivors, it has not been utilized in adults with cancer or in marginalized communities. Adapting this intervention to this context will require the testing of the intervention and, importantly, tailoring to meet the needs of women with breast cancer, particularly those of marginalized populations who may uniquely benefit from this intervention.

This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing neoadjuvant chemotherapy with early-stage breast cancer, women undergoing treatment for metastatic breast cancer

Exclusion Criteria:

* patients who do not speak English
Corticosteroids in the Treatment of Tuberculous Pleurisy

Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent;
* Presented with clinical features suggesting pleural tuberculosis;
* Had not previously received treatment or prophylaxis for tuberculosis;
* Had not recently received treatment with glucocorticoids;
* Were not pregnant or breast-feeding.

Exclusion Criteria:

* Failed to complete the screening procedures;
* Were seropositive for HIV
* Tuberculous meningitis;
* Had risk factors for serious steroid-related adverse events (a history of diabetes or positive urine glucose, a history or clinical finding of hypertension, or a history of peptic ulcer disease or mental illness);
* Standard doses of antituberculosis drugs could not be used (as in participants with concurrent liver disease)
* Psychiatric illness;
* Alcoholism.
Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Eligibility Criteria:
Key Inclusion criteria

* Osteoarthritis of the knee Key Exclusion criteria
* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2 Diabetes Mellitus and Microalbuminuria.

The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus
* Male or female subjects aged 20 years or older at informed consent
* Subjects with urinary albumin to creatine ratio (UACR) ≥ 45 mg/g Cr and \< 300 mg/g Cr
* Estimated glomerular filtration rate by creatinine (eGFRcreat) ≥ 30 mL/min/1.73 m\^2
* Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 3 months prior to treatment period

Exclusion Criteria:

* Type 1 diabetes
* HbA1c (NGSP) \>=8.4%
* Secondary glucose intolerance
* Subjects diagnosed with non-diabetic nephropathy
* Nephrotic syndrome
* Secondary hypertension or malignant hypertension
* Serum potassium level in any of the following categories: For subjects with eGFRcreat of ≥ 45 mL/min/1.73 m\^2, serum potassium level of \< 3.5 mEq/L or ≥ 5.1 mEq/L; For subjects with eGFRcreat of ≥ 30 mL/min/1.73 m\^2 and \< 45 mL/min/1.73 m\^2, serum potassium level of \< 3.5 mEq/L or ≥ 4.8 mEq/L
Non-invasive Brain Stimulation (NIBS) and Dual-task Walking After Stroke

The study aims to identify neural locus critical for dual-task walking (walking and talking) in individuals with stroke. To achieve this aim, the investigators apply repetitive transcranial magnetic stimulation (rTMS) to different parts of the brain and evaluate the effects of brain stimulation on dual-task walking speed.

This study will enroll 12 individuals with a stroke at least 6 months ago. Participants will be tested across 3 sessions and each session will be approximately 1 week apart from each other. During testing, participants will be asked to walk under two conditions: single- and dual-task conditions. Under the single-task condition, participants walk on a instrumented mat such that their gait performance will be captured. Under the dual-task condition, participants walk on the mat while performing a counting backward task. The walking assessment is followed by a 12 minute non-invasive brain stimulation using high frequency rTMS. Another walking assessment will be conducted right after the brain stimulation session. High frequency rTMS will be applied to different neural loci, namely primary motor cortex (M1), supplementary motor area (SMA), and dorsolateral prefrontal cortex (DLPFC). The walking speed under two different conditions will be compared before and after brain stimulation to different neural loci.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years
2. Diagnosis of Left hemispheric stroke at least 6 months ago
3. First time stroke OR complete gait recovery from prior stroke
4. Able to walk independently for at least 10 meters with or without walking aids
5. Have at least minimal movements (\> 5 degree of motion) at the affected ankle
6. Score \> 26 on Mini Mental State Exam (MMSE)
7. Ability to participate in the informed consent process

Exclusion Criteria:

1. Diagnosis of other neurological conditions, such as Parkinson Disease, Alzheimer, Spinal Cord Injury, Multiple Sclerosis
2. Other comorbidities which could interfere with gait (i.e. amputation, severe osteoarthritis)
3. Unstable clinical conditions
4. Non-ambulatory prior to onset of stroke
5. History of significant head trauma
6. Electrical, magnetic, or mechanical implantation: cardiac pacemakers or intracerebral vascular clip
7. Metal implantation in the oral cavity, head/neck area and lower extremity
8. Pregnancy
9. History of seizures or unexplained loss of consciousness
10. Immediate family member with epilepsy
11. Use of seizure threshold lowering medicine
12. Current abuse of alcohol or drugs
13. Anticipated inability to complete the study
14. History of psychiatric illness requiring medication control
Classification of Stanford for Snore as Factor of Aggravation of the Apnea Hypopnea Index (AIH) in Patients With Obstructive Sleep Apnea Syndrome (OSAS)

Introduction: Obstructive sleep apnea syndrome (OSAS) became an important and prevalent illness in recent years. The population occidental becomes fat each time, and this symptom is associated the biggest risk for the OSAS. Snore presence is extremely associated with OSAS. Snoring is present in about 90 - 95% of the patients with OSAS.

Objectives: Evaluate the influence in the Stanford classification as predictor factor of gravity of the OSAS.

Materials and Methods: They evaluated and classified 107 patients, Classification of Mallampati, Friedman, Classification of Stanford and how much the gravity of the OSAS for the AIH.


Eligibility Criteria:
Inclusion Criteria:

* Not exhibiting any exclusion criteria
* Age \> 21 years

Exclusion Criteria:

* Nasal tumor
* BMI \>40
* Nasal polipose
* No acceptance of study
Hysteroscopy for Pregnancy of Unknown Location

About 10% of early pregnancies can not be visualized by transvaginal ultrasound (TVU) on first visit and are classified as pregnancy of unknown location (PUL). The etiology includes ongoing intra-uterine pregnancy, failing pregnancy, or ectopic pregnancy. Early diagnosis of ectopic pregnancy is important because it allows conservative treatment. Serum β-hCG, D\&C, and laparoscopy are routinely used as diagnostic methods. The purpose of the study is to evaluate if the less invasive office hysteroscopy (HSC) can help diagnose PUL.

If TVU showed no evidence of intra-uterine and extra-uterine pregnancy, a blood test for β-hCG was done. If β-hCG was \< 1000 IU/L, the woman was followed with β-hCG 2 days later. Women with β-hCG \> 1000 IU/L or abnormal β-hCG trend (increase \< 66% or decrease \< 15%) were offered HSC. If gestational tissues were visualized, ectopic pregnancy was ruled out. Otherwise, the tentative diagnosis was ectopic pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* women with PUL

Exclusion Criteria:
Comparative Effect of Scapular Stabilization vs Thoracic Extension Exercises in Young Adults With Text Neck Syndrome.

The aim of the study is to compare the effect of scapular stabilization versus thoracic extension exercises on pain, disability, range of motion, and cranio-vertebral angle in young adults with Text Neck Syndrome.

Text neck has emerged as a widespread modern epidemic that affects people of all ages, particularly younger populations, as they are exposed to handheld mobile device use for several hours a day beginning at a very early age. The relation between the posture due to handheld mobile device use and neck pain is still debatable. To manage the maladaptive posture of the cervical spine, indirect treatment instead of direct treatment of the neck can be used, which is the basis for the concept of regional interdependence, i.e., the cause of pain becomes the cause of damage to other body parts. Therefore, not treating the damaged part, but indirectly treating the area of cause can alleviate the symptoms. A bio-dynamic relationship between the cervical and thoracic spine is associated with exercise, an important factor causing neck pain. Therefore, many clinicians pay attention to the thoracic spine of patients with neck pain and recommend thoracic extension exercises. On the other hand, many researchers recommended scapular stabilization exercise as a recovery treatment for imbalanced scapular muscles caused by forward head posture.

This study investigates how exercise programs not directly applied to the cervical spine affect people with text neck syndrome. The significance of the current study is to evaluate the comparison between concentric and eccentric exercise which is previously rarely investigated.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female participants with forward head posture or text neck syndrome
* Participants with neck pain from the past three months
* Smart-phones must be used for at least ≥3 hours each day
* Participants with craniovertebral angle \<53° will be included in this study

Exclusion Criteria:

* History of cervical and thoracic spine surgery within the past three months
* Serious pathological conditions within the past three months
* Congenital spinal anomalies, or rheumatoid arthritis
* Neurological signs and severe psychological disorders
Effect of Dietary Fiber on Non-dialysis Patients With Chronic Kidney Disease

The main objective of this study was to investigate the effect of dietary fiber on anemia and glomerular filtration rate in non-dialysis patients with chronic kidney disease. Participants will be randomly divided into a dietary fiber intervention group and a blank control group. The patients in the dietary fiber intervention group will have dietary fiber intake survey conducted by dietitians on the basis of basic treatment. Supplemented dietary fiber was given on the basis of daily diet, once a day, 1 piece each time, before meals, and the intervention lasted for 3 months. The blank control group was followed up without intervention. Clinical data, blood, urine and stool samples were collected at the initial diagnosis and at each follow-up site.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old;
* Clinically confirmed (history, blood creatinine, kidney B-ultrasound, laboratory examination, etc.) as stage 3-5 chronic kidney disease, endogenous creatinine clearance was \< 60ml/min according to Cockcroft-Gault formula;
* Generally in good condition, have a good understanding of their own illness and physical condition, have self-awareness, and can communicate well with others;
* Hemoglobin 100-130g/L;
* In a non-dialysis state.
* Dietary fiber intake \<25g/d;
* Voluntarily join the study, understand the significance of the test and the indicators to be measured, and sign the informed consent.

Exclusion Criteria:

* Unwilling to join the study; Severe infection: fever, cough and sputum, pharyngeal pain, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/L);
* Severe cardiovascular diseases: including chronic cardiac insufficiency grade 3 or above and various arrhythmias;
* Obvious hypoproteinemia: albumin less than 30g/L;
* Corrective measures for anemia (blood transfusion, erythropoietin, HIF-PHI, iron supplement) have been applied in the past 3 months;
* Tumor evidence: certain tumors have been detected or clinical manifestations and tumor markers suggest the possibility of tumor;
* Pregnant women;
* Recent history of heavy blood loss.
The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.

The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants

This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.


Eligibility Criteria:
Inclusion criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results.
* Body weight greater than or equal to (\>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive).
* Women who have the potential to become pregnant must use a form of highly-effective contraception.
* Capable of giving signed informed consent.

Exclusion Criteria:

* History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
* Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe drug allergies/intolerance.
* Current evidence or recent history of an infective illness.
* A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
* Clinically significant abnormalities.
* Positive test for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at screening.
* Recent prior or concurrent clinical study experience.
Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension

The primary objective of this study is to compare the effectiveness of telmisartan 80 mg / hydrochlorothiazide 25 mg \[Micardis HCT\] to valsartan 160 mg / hydrochlorothiazide 25 mg \[Diovan HCT\] and placebo in the treatment of Stage 1 and Stage 2 hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent.
2. Age 18 years or older
3. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
4. Seated cuff DBP of ? 95 mmHg at Visit 2 (baseline)

Exclusion Criteria:

1. Pre-menopausal women (last menstruation ? 1 year prior to start of run-in period) who:

   1. are not surgically sterile and/or
   2. are nursing or pregnant
   3. are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of \> 3-months duration. Acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device (IUD).
2. Known or suspected secondary hypertension.
3. Mean seated SBP \>= 180 mmHg or mean seated DBP \>= 120 mmHg during any clinic visit prior to randomization.
4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

   1. SGPT (ALT) or SGOT (AST) \> 2 times the upper limit of normal range, or
   2. Serum creatinine \> 3.0 mg/dL or creatinine clearance \< 0.6 ml/sec.
5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
6. Clinically relevant hypokalemia or hyperkalemia.
7. Uncorrected volume depletion.
8. Uncorrected sodium depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency.
12. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
13. History of drug or alcohol dependency within six months prior to start of run-in period.
14. Chronic administration of any medications known to affect blood pressure, exc