cyrilzakka/clinical-trials huggingface dataset:
Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis

To evaluate therapeutic response to MMF treatment in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic acid levels at 1-hour post dose will be monitored monthly up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 16-60 years.
* Ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements
* Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening
* Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (\>90% chronic irreversible scarring)

Exclusion Criteria:

Relates to SLE

* Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR \< 30 ml/min(except creatinine clearance or MDRD-GFR \> 50 ml/min in the 12 weeks prior to screening)
* History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.

Related to Treatment

* Previous of any Mycophenolate groups in the 3 months prior to screening.
* Treatment with more than 2 g Cyclophosphamide in the last 6 months period prior to screening.
* Receipt of more than 3 g IV pulse methylprednisolone within the last 3 months prior to screening.
* Receipt of prednisolone dose \> 30 mg/day for longer than 30 days within last 3 months prior to screening.

Related to General Health

* Pregnancy or breast feeding mothers.
* Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.
* History of cancer, including solid tumors, hematological malignancies and carcinoma.
* History of serious recurrent or chronic infection.
* Evidence of current abuse of drugs or alcohol.

Related to Laboratory Findings

* Neutrophile \< 1,500/mm3, Hb \< 7g/L, Platelet \< 50,000/mm3 (except active SLE)
* Positive HBsAg or anti-HCV or anti-HIV.
Renal Impairment in Type 2 Diabetic Subjects

The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects in the following groups:

Group A: Healthy Subjects with Normal Renal Function (CLcr \> 80 mL/min) Group B: Diabetic Subjects with Normal Renal Function (CLcr \> 80 mL/min) Group C: Diabetic Subjects with Mild Renal Impairment (CLcr \> 50 - ≤80 mL/min) Group D: Diabetic Subjects with Moderate Renal Impairment (CLcr ≥ 30 - ≤50 mL/min) Group E: Diabetic Subjects with Severe Renal Impairment (CLcr \< 30 mL/min) (and not receiving dialysis)

* Men and WOCBP, ages 18 to 79 years old

Standard Exclusion Criteria, plus:

* History of diabetic ketoacidosis
* HbA\*1c \> 10%
* Serum albumin \< 2.0 gm/dL
* Potassium \< 3.0 or \> 6.0 mEq/L
Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration

Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.

The functional changes of the retina can be recorded by an electroretinography (ERG).

Eligibility Criteria:
Inclusion Criteria:

* Age 45 years and above
* Clinical diagnosis of wet AMD
* First injection of ranibizumab protocol
* Best corrected visual acuity 20/32 - 20/320
* Consent form obtained

Exclusion Criteria:

* Previously treated wet AMD patients
* Patients with other ocular diseases which can cause abnormal ERG such as glaucoma, uveitis or retinitis pigmentosa, etc.
* Pregnancy
* History of seizure
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be quite long lasting and debilitating. Dextrose injection with a small needle has be notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with saline injection for temporomandibular(jaw) dysfunction, also known as TMD.

Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of symptom diminishment, especially in the elderly. However studies out to 2-8 years show residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been utilized empirically for many years and a marked reduction in pain and luxation after intraarticular and pericapsular dextrose injection has been reported in a recent RCT. However, small study size and lack of a non injection control have prevented any definitive conclusions as the additional efficacy of including dextrose in the injectate. The mechanism of action of dextrose injection was originally thought to be via a brief stimulation of the inflammatory cascade with resultant production of growth factors. However, non-inflammatory dextrose effects on growth factor production have been demonstrated, and, more recently, dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). This has the theoretical benefit of reducing pain, regardless of the status and position of the intraarticular cartilage or degree of degenerative change of the TMD. The primary goal of this study is to evaluate the ability of dextrose injection versus saline injection to reduce pain and improve functional complaints referable to the temporomandibular joint.

Eligibility Criteria:
Inclusion Criteria:

* Facial Pain NRS rating \> 5/10
* Jaw symptom rating \> 5/10
* Jaw function issues seen on examination

Exclusion Criteria:

* Any potential acute dental issue
* Rheumatic inflammatory disease
* Chronic intake of NSAIDs or corticosteroids.
* Pain in other body location worse than jaw pain
* Pain 10/10 in other body location.
Bone Markers in Pediatric IF

Poor bone health is a well-recognized but poorly understood complication in children with intestinal failure (IF) who are dependent on parenteral nutrition (PN). Previously, we showed that children with IF have decreased bone turnover markers. It is currently unknown if optimization of parenteral nutrition is related to improved bone turnover markers. Serum concentrations of bone markers (osteocalcin, bone-specific alkaline phosphatase and c-telopeptide) will be measured in 30 IF patients treated at a multidisciplinary intestinal rehabilitation and home PN program at the Hospital for Sick Children and compared to bone markers in 30 age- and sex-matched healthy controls.

It is currently unknown if optimization of PN mixtures leads to a measurable change in bone turnover markers. Our hypothesis is that bone turnover markers of children with IF whose PN has been optimized will not differ from those of healthy control subjects, with a positive effect on bone mineral density.

Our aims are:

* To measure bone turnover markers in children with IF on long-term PN and compare them with age- and sex-matched healthy children who never received PN
* To evaluate if changes in bone turnover markers are related to changes in bone mineral density measured by Dual energy X-ray absorptiometry (DXA)
* To identify IF- and PN-related factors associated with bone health

To be able to answer these aims, bone markers in children with IF will be compared to bone markers in healthy controls, age- and sex-matched.

Eligibility Criteria:
Inclusion criteria are as follows:

In order to be eligible to participate in this study, a patient must meet all of the following criteria at time of inclusion:

1. Consent provided
2. Age \< 18 years
3. Suffering from IF needing PN providing at least 25% of calories for ≥6 weeks
4. Medically stable with no acute changes in condition requiring hospitalization, or other intervention at home (for at least 3 months).

For healthy controls the inclusion criteria are as follows:

1. Consent provided
2. Age \< 18 years.

A patient who meets any of the following criteria will be excluded from participation in this study:

1. On PN for \< 6 weeks
2. Suffering from an acute clinical event, for example gastroenteritis, colds and flu
3. Suffering from sepsis on antibiotics
4. On medication known to affect bone metabolism, for example steroids
5. Having a history of fracture within the last 12 months.

For healthy controls, the exclusion criteria are as follows:

1. Any condition known to affect bone health (chronic disease, bone disease, history of malignancy, radiotherapy, steroid use, mental or physical disability)
2. A positive history of fractures within the past 2 years
3. Poor growth (weight- and height-for-age below - 2 or above + 2 standard deviation score using the WHO growth charts).
Role of Depression in Blood Pressure Control. Study

Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients.

Research Problem: Hypertension is a multifactorial disease that affects approximately one quarter of the adult population. It is a major risk factor for stroke and cardiovascular disease.

Environmental and psychosocial factors play an important role in hypertension onset and control. The prevalence of depression among hypertensive patients is 26, 8% and its presence is associated with increased risk of cardiovascular-related morbi-mortality. Our study aims to evaluate the role of depression in blood pressure control in ambulatory hypertensive patients. Investigative process: This study is a cross-sectional, multicentric and descriptive study. the investigators intend to include three hundred and two patients. After obtaining their consent, a 24 hour ambulatory blood pressure monitor will be used to evaluate blood pressure control.

Depression was assessed by the 9-item-Patient Health Questionnaire (PHQ-9) in Tunisian dialect. Clinical, socio-environmental, psychosocial and therapeutic and prognosis data will be collected from medical records.

Eligibility Criteria:
Inclusion Criteria:

* Patients consulting for high blood pressure
* Patients older than 18 years.
* Patients able to give informed consent.

Non inclusion Criteria :

* Patients followed for depression under treatment.
* Hospitalized patients

Exclusion Criteria:

* a white coat hypertension
A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma or ocular hypertension
* Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons

Exclusion Criteria:

* None
Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs

The class of proton pump inhibitor (PPI) medications such as omeprazole has proven extremely effective in the treatment and prevention of gastric and duodenal ulcers. Although the FDA approval for PPI therapy is limited to 6-8 weeks, many individuals remain on these agents for years, and human studies have suggested that long-term use of a PPI can result in enterochromaffin-like (ECL) cell hyperplasia, as well as being associated with the development of fundic-gland polyps of the stomach. These findings raise the concern of the possibility that long-term use of PPIs may predispose to the development of neuroendocrine tumors in patients. The investigators aim to examine clinical parameters, including history of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. The investigators hypothesize that there is a correlation between fundic gland polyps of the stomach and the use of proton pump inhibiter medications.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above.
* Able and willing to sign informed consent.
* The patient had a gastric fundic gland polyp detected on EGD that was removed and sent to pathology or patient had no fundic gland polyps on EGD but are on PPIs and will serve as controls.

Exclusion Criteria:

* Unwilling or unable to sign informed consent for the study.
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

This open label dose escalation and expansion study will be conducted using a standard dose-escalation design with escalating doses of eflornithine plus temozolomide at the approved dose level, followed by an expansion cohort that will further evaluate safety and preliminary efficacy of the combination at the recommended phase 2 dose.

Duration of participation will be up to 56 weeks in total per patient:

Screening Period - A maximum screening duration of 4 weeks.

Treatment Period - Up to 48 weeks.

Follow-Up Visit - 4 weeks from last treatment.

A total of up to 66 patients will be enrolled in a non-randomized fashion (patients may be added to any of the dose levels below the RP2D to a maximum of approximately 20 per dose level with the intent of further characterizing safety and pharmacokinetics).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype per WHO 2021 tumor classification.
* Completed external beam radiation therapy per standard of care.
* Must have received at least 80% of planned daily doses of TMZ during chemoradiation.
* Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.
* Willing to abstain from intercourse or use acceptable contraceptive methods.
* If taking corticosteroids, must be on a stable or decreasing dose.

Exclusion Criteria:

* Recent history of recurrent or metastatic cancer that could confound response assessments
* Prior systemic chemotherapy for GBM other than temozolomide during external beam radiation therapy.
* Prior Optune treatment.
* Active infection or serious intercurrent medical illness.
* Poorly controlled seizures.
* Significant cardiac disease within 6 months of enrollment.
* Poorly controlled diabetes.
* Use of another investigational agent within 30 days of enrollment.
Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).

The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to understand and sign an approved informed consent form.
* Exhibit symptoms of dry eye at the Screening visit.
* Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.
* Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant during the study.
* Ocular abnormalities that could adversely affect the safety or efficacy outcome.
* Uncontrolled active systemic diseases.
* Use of systemic medications known to cause dry eye.
* Other protocol-defined exclusion criteria may apply.
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females

The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females.


Eligibility Criteria:
Inclusion Criteria:

* females (18-65 years old)
* dysuria in symptomatic non complicated urinary tract infection

Exclusion Criteria:

* Pediatric Patients (\< 18 years old)
* geriatric Patients (\> 65 years old)
* pregnant Patients
* Patients with complicated urinary tract infection
* sexually transmitted infections
* Patients with pathological abnormalities in the urinary bladder, including stone/mass
* Catheter-mounted
* Neurological diseases/disorders
* patients with allergy/hypersensitivity with Levofloxacin/Solifenacin
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active systemic lupus erythematosus (SLE)


Eligibility Criteria:
Key Inclusion Criteria Summary

* SLE onset ≥ 6 months prior to Screening
* Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test
* Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor, including a SLEDAI score at Screening of ≥ 6 and a clinical score at Baseline of ≥ 4
* Standard lupus medications must be stable prior to Screening

Key Exclusion Criteria Summary:

* Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study
* Proteinuria consistent with nephrotic syndrome
* Active lupus-related neuropsychiatric disease
* Drug-induced lupus
* Recent or serious ongoing infection; risk or history of serious infection
* Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study
* Prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
* Diagnosis of, or fulfills diagnostic criteria for fibromyalgia
* Functional class IV
* Serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk
Prevention of Chest Pain in Chemo-treated Cancer Patients

This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard oncological treatment or a cardiological assessment prior to the 5-FU treatment. The investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic patients will reduce the number of hospitalisations and investigations for acute coronary syndrome during and after 5-FU treatment and that patients with high coronary artery calcium scores are more likely to experience chest pain during the treatment with 5-FU.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified cancer
* First-time treatment with 5-FU/Capecitabine
* Expected remaining lifetime \> 6 months
* Informed consent

Exclusion Criteria:

* Known ischemic heart disease
* Ischemia-suspicious symptoms prior to 5-FU treatment
* Ischemia-suspicious ECG-changes prior to 5-FU treatment
An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)

A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults who are between the ages of 18 and 64

Exclusion Criteria:

* Adults who are diagnosed with insomnia
Distance From the Glottis to the Grille in Children

Ambu AuraGain, I-gel, Air-Q intubating laryngeal airway are the most commonly used supraglottic airway. In children, they can be used as intubation conduits. However, there has been no guideline for optimal insertion depth of endotracheal tube through those supraglottic airway. In this study, the investigators will measure the distance from grille of those supraglottic airways to glottis using fiberoptic bronchoscope in children undergoing anesthesia. This distance allows us to predict an appropriate depth of endotracheal tube when it should be inserted through each supraglottic airway.


Eligibility Criteria:
Inclusion Criteria:

* children \< 7 years old undergoing elective surgery

Exclusion Criteria:

* difficult airway
* BMI\> 30kg/m2
* emergency operation
* cervical spine disease
* history of esophageal disease and surgery
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.

The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* Women, 18 years or older in good General health
* Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter ≥ 30 mm and \< 120 mm
* Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of \>80.00 mL documented by alkaline hematin (AH) method
* An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
* Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study

Exclusion Criteria:

* Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)
* Hypersensitivity to any ingredient of the study drug
* Any condition requiring immediate blood transfusion
* Laboratory values outside inclusion range before randomization and considered as clinically relevant.
* Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Abuse of alcohol, drugs, or medicines (eg, laxatives)
* Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
* Undiagnosed abnormal genital bleeding