cyrilzakka/clinical-trials huggingface dataset:
Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D

The purpose of this study is to determine the value the additional antiproteinuric effects of vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV, with lack of vitamin D and residual proteinuria higher 0,5 grams/day.


Eligibility Criteria:
Inclusion Criteria:

* Male/female Patients older 18 years old
* Patients have signed written informed consent
* Chronic Kidney Illness phase II-IV plus residual proteinuria \>0,5 grams/day (two or more consecutive occasions) and plus beta blockers treatment from AARS during al least 3 months.
* Serum levels of calcifediol in the lack of level (15-30 ng/ml).

Exclusion Criteria:

* Bad control of high blood pressure (higher or same 180/110 mmHg)
* Bad control of diabetes (HbA1c higher 9,5 in the last three months period)
* Hypercalcemia (\<10,2 mg/dL) o hyperphosphatemia(\>5,5 mg/dL), CaxPO4\>50, hypercalciuria (urin Ca/Cr quotient \> 0,15)
* Vitamin D treatment or any analogous
* Hepatic failure ( AST o ALT \> 3 times higher than normal limit)
* medical history of poor nutrient intestinal absorptions or chronic diarrhea
* Active nephrolithiasis
* Treatment with medication wich can change vitamin D metabolism (phenobarbital, phenytoin, rifampicin)
* Participation in other Clinic Trial in 3 last months
* Active Alcoholism
* Neoplasia precedent (except cutaneous no melanoma)
* Pregnant women or while breastfeeding
* Vitamin D hypersensitivity or any its excipient hypersensitivity
* Any other condition from Research
A Study of KNT-0916 in Treatment of Unresectable or Metastatic Solid Tumors with FGFR2 Alterations

This is a Phase1, open-label, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of KNT-0916 in patients with unresectable or metastatic solid tumors harboring FGFR2 alterations who have failed prior systemic therapy. This study is divided into 2 parts, dose escalation part(part A), dose expansion part(partB).

This study is divided into 2 parts, part a isNdesigned to explore the maximum toxicity dose (MTD) of KNT-0916 with an accelerated titration plus traditional "3+3" design; part b is designed to explore the elementary anti-neoplastic activity of KNT-0916 with recommended dose in patients with confirmed FGFR2 alterations through central laboratory testing.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed unresectable or metastatic solid tumor
* Documented FGFR2 gene fusion, mutation, or amplification per testing of blood and/or tumor
* Patient must have measurable disease per RECIST v1.1
* Patient has ECOG performance status of 0-1
* Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy
* An expected survival of ≥ 12 weeks.
* Adequate organ function, as measured by laboratory values

Exclusion Criteria:

* Prior treatment with any FGFR2 target therapy.
* Central nervous system metastasis with associated symptom and signs.
* Clinically significant, uncontrolled cardiovascular disease.
* History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy 5. As judged by the investigator, unsuitable for attending the study.
Long-term Follow-up of Participants Treated with Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies

This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion.

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit/risk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.


Eligibility Criteria:
Inclusion Criteria:

* All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.

Exclusion Criteria:

* There are no exclusion criteria for this study
Acute Comfort of Lubricant Eye Drops FID 112903

To evaluate the acute comfort and blurring profile between two artificial tears in dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of dry eye
* Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

* Age related
Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams

The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Body Mass Index (BMI) of 30 or less
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating
Neonatal Resuscitation With Intact Cord

The purpose of this study is to examine whether providing ventilation during delayed umbilical cord clamping provides greater placental transfusion and improved hemodynamic transition at birth.

Subjects will receive 1 minute of delayed cord clamping in both arms. One arm will receive routine care, warm dry and stimulate during the 1 minutes transfusion. The second arm will receive routine care PLUS administration of CPAP and if need positive pressure ventilation. The outcome is to determine whether the addition of ventilation provides a larger placental transfusion and a smoother transition at birth.

Eligibility Criteria:
Inclusion Criteria:

* Gestational Age: Women admitted 23+0 to 31+6 weeks (Reason: Highest risk for IVH)

Exclusion Criteria:

* Gestational Age: Parents decline consent (Reason: Can only perform intervention at time of delivery)
* Congenital anomalies of newborn (Reason: Exclude the effect of abnormal hematological function)
* Placental abruption (Reason: Exclude pregnancies at risk for hemorrhage at the time of delivery)
* Twin to twin transfusion (Reason: Exclude possible loss of blood from other twin during delayed cord clamping)
* Placenta Accreta
* Prolonged premature rupture of membranes (\> 2 weeks) prior to 23 weeks gestation
Aripiprazole Treatment of Prodromal Patients

We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the schizophrenia prodrome when they are prescribed aripiprazole.

This is an 8 week trial with extension for responders out to one year. All patients receive active medication; there is no placebo. Patients must meet criteria for the schizophrenia prodrome according to the Structured Interview for Prodromal Syndromes. Patients receive counseling as well. All counseling and medication are free of charge.

Eligibility Criteria:
Inclusion Criteria:

* age 13 to 40 meet criteria for the prodrome for schizophrenia

Exclusion Criteria:

* history of psychosis
Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed.


Eligibility Criteria:
Inclusion Criteria:

* patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy)
* approval and informed consent

Exclusion Criteria:

* chemotherapy
* locoregional radiotherapy
* prevalent axillary lymph node
Evaluation of VELCADE Given as Retreatment to Multiple Myeloma Patients for Efficacy, Safety and Tolerability

Multiple myeloma represents the second most common hematological malignancy.VELCADE is a small molecule to treat human malignancies. Its anti-neoplastic effect invovles several distinct mechanisms including inhibition of cell growth. Patients who have relapsed or are refractory to therapy, the standard of care is now VELCADE based on the results of previous clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent with the understanding that the consent may be w/d by the patient at any time w/o prejudice to future medical care.
2. Patient previously diagnosed with Multiple Myeloma (MM).
3. Patient previously tolerated 0.7, 1.0, or 1.3 mg/m2/dose of VELCADE alone or therapy combination and had at least a greater/equal 50% reduction in M-Protein upon completion of VELCADE therapy. The DOR prior to VELCADE greater/equal 4 months for the patient population.
4. It has been greater/equal 2 months since the patient's last VELCADE dose and the patient meets certain Lab criteria as per protocol.
5. Patient has a Karnosfsky performance status greater/equal 60%.
6. Patient has a life-expectancy greater than 3 months.
7. Patient has laboratory values (defined in protocol) within 14 days before enrollment.

Exclusion Criteria:

1. Patients with a Hx of PD, minimal response, or stable disease (SD)on first exposure to VELCADE.
2. Patient has received chemotherapy, radiotherapy, immunotherapy or experimental therapy to treat multiple myeloma since their last dose of VELCADE.
3. Patients who achieved a CR or PR but relapsed while on therapy.
4. Patient had major surgery w/in 2 wks before enrollment.
5. Patient has a Hx of allergic reaction to compounds containing boron or mannitol.
6. Patient has peripheral sensory neuropathy of Grade 2 w/pain or greater intensity.
7. Patient has cardiac amyloidosis.
8. Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or pysychiatric illness.
9. Patient is known to be human immunodeficiency virus (HIV)+.
10. Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.
11. Patient has an active systemic infection requiring treatment.
12. Female patient is pregnant or breast-feeding. Confirmation must be established by a negative serum B-hCG.
13. Patient is currently enrolled in another clinical research study.
Osmotic Therapy for Patients with Severe Subarachnoid Hemorrhage

The goal of this prospective multi-center observational study is to learn about the osmotic therapy in severe subarachnoid hemorrhage (SAH). The main question\[s\] it aims to answer are:

• whether the two osmotic therapy, 20% mannitol and 10% hypertonic saline(HTS), under the same osmotic equivalent, has similar influence on the outcome of SAH patients?

Participants will be given proper treatment according to local expert consensus, including the choice of osmotic medicine. Investigators just record and analyse the data, compare mannitol group and HTS group to see if the outcome of latter is not worse than the former.


Eligibility Criteria:
Inclusion Criteria:

* ①age ≥18； ②aneurysmal subarachnoid hemorrhage; ③Hunt-Hess 3-5级

Exclusion Criteria:

* previous cranial decompression surgery, cerebrospinal fluid leakage or drainage,

  * bilateral pupils fixed or dilated,

    * hemodynamic instability,

      * hemoglobin \< 8g / L,

        * serum osmolality \> 320 mOsm / L,

          ⑥ combined with severe organ dysfunction (cardiac, pulmonary, hepatic, renal and so on);

          ⑦ serious electrolyte disorders (serum sodium concentration \<125 mmol / L or \>170 mmol / L), and difficult to correct within limited time;

          ⑧ serious acid-base balance disorders, and difficult to correct within limited time;

          ⑨ use of mannitol or HSS within previous six hours;

          ⑩ being pregnant.
Transversus Abdominis Plane Block During Kidney Transplant Surgery

The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. The catheter will deliver one of two products chosen at random: either ropivacaine or placebo.

This study will evaluate postoperative pain during the first 24 hours thanks to a recognized indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also be recorded, starting with the titration of morphine in the post-op room, and then the consumption of classical analgesics in the nephrology department. These will only be given if the VAS score is equal to 4 or above.

This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2% versus placebo in continuous TAP block during the first 24 hours after the operation in patients undergoing kidney transplant surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient opéré for kidney transplant
* Patients who have provided written informed consent
* Patients with national health insurance cover
* Patients aged 18 years and above

Exclusion Criteria:

* Pregnant or breast-feeding women
* allergies/hypersensitivity to paracetamol (or propacetamol chlorhydrate (paracetamol pro-drug) or one of its excipients), to local anesthetics, morphines (or other constituents)
* patients under guardianship or ward of court
Using Serious Games to Improve Social Skills in Autism

The investigators will conduct a small-scale randomized control trial comparing the intervention game to an active control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). These outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to uncontrolled, real-world social interactions between dyads.

The investigators will conduct a small-scale randomized control trial comparing the intervention game to an placebo control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). These outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to real-world social interactions between dyads. The aims are evaluating 1) changes in the target mechanisms (social attention to faces, sensitivity to eye gaze cues) for the intervention relative to active control group, 2) engagement of intermediate mechanisms, including face-processing behaviors and real-world social communication behaviors, and 3) the relation between engagement of the target and intermediate mechanisms and symptom outcomes. Evidence of changes in autism social symptoms resulting from changing visual attention to faces and/or improved ability to understand eye gaze cues will provide clear evidence to inform a "go" decision about the therapeutic target for further clinical development.

Eligibility Criteria:
Inclusion Criteria:

1. parent/caregiver of an adolescent with a diagnosis of autism spectrum disorder (ASD),
2. parent/caregiver and adolescent with ASD both native English speakers,
3. adolescent with ASD aged between 10-18 years at pre-test,
4. adolescent has normal vision and hearing with correction as reported by caregiver,
5. adolescent is able to use a computer for the purposes of game play,
6. adolescent scores \< 80% correct (i.e., 0.5 SD less than Mean of typically developing adolescents) on online eye gaze screening task,
7. ASD diagnosis of adolescent confirmed via Parent-report SCQ and clinical interview with adolescent to assess DSM-V criteria (borderline cases also undergo ADI interview);
8. Full Scale IQ of adolescent determined to be between 70-130;
9. reading ability of adolescent determined to be at least a 2nd grade level;
10. adolescent is capable of cooperating with testing;
11. parent/caregiver and adolescent both consent/assent to participate in the research.

Exclusion Criteria:

1. having seizures within the previous two years
2. no stable internet connection in the home
3. refusing to consent/assent to take part in the research
4. 18 and have a legal guardian, which prohibits them from legally consenting for themselves
5. 18 and cannot understand the consent as indicated by failing a quiz prior to signing the consent.
Effectiveness of a Massage Instrument Compared to Placebo for Upper Trapezius Muscle Pain

The purpose of this study was to determine if using a specialized massage tool was more effective than a placebo treatment in relieving pain in the upper trapezius muscle along the top of the shoulder.

The purpose of the study was to determine if a statistically significant and clinically meaningful difference exits between the FascialEdge tool and placebo in the treatment of latent upper trapezius trigger points.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* between 18-64 years of age
* a latent trigger point of the upper trapezius muscle

Exclusion Criteria:

* an active trigger point of the upper trapezius muscle
* rash or infection of the skin over the trigger point
* neck pain
* taking anticoagulant drugs
* spontaneous bleeding
* long term corticosteroid use
A Study of Single Ascending Dose of LEM-S401 in Healthy Participants

The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.

This study is designed to evaluate the safety and tolerability of LEM-S401 administered as subcutaneous injection in healthy adult subjects.

Overall, 18 subjects will be studied in 3 groups. Each subject will receive LEM-S401 or placebo subcutaneously.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 19 to ≤ 65 years at screening

Exclusion Criteria:

* Significant history or clinical manifestation of any hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, tumor, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, dermatological (eg, contact dermatitis, atopic dermatitis), or other
* History of drug abuse or positive urine drug screen at screening
* For all female subjects, pregnant (Urine-HCG positive) or breast-feeding subjects
A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast

The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 18 and 33

Exclusion Criteria:

* Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, allergic or other major disorders.
* Use of any prescribed or non-prescribed systemic or topical medication (including vitamins and herbal medicines, e.g. St. John's Wort) within 30 days of the first dose, unless an exception is granted by the sponsor.
* Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
* Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration
Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy

CMR GUIDE DCM is a randomized controlled trial with a registry for non-randomized patients.

Patients enrolled will have non-ischemic cardiomyopathy (NICM) with mild to severe Left Ventricular (LV) systolic dysfunction with replacement fibrosis identified on Cardiac Magnetic Resonance (CMR).

954 patients will be randomised from 50 sites across 4-6 countries worldwide to receive an implantable defibrillator (ICD) or implantable loop recorder (ILR).

Device and clinical follow-up will be performed at 3, 6, 12, 24, 36 months and at end of study.

The planned research will have two components: A prospective, blocked, randomized, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF \<45% and Late Gadolinium Enhancement (LGE) on CMR and

A prospective observational registry of patients with LVEF \<45% and no LGE on CMR. Registry patients will not have an intervention but will have the same follow up frequency as the randomized patients.

The Primary objective is to determine if routine CMR guided management strategy of implantable defibrillator (ICD) insertion reduces total mortality compared to a conservative strategy of implantable loop recorder (ILR) insertion and standard care.

The secondary objectives include:

* To determine if routine CMR guided management strategy of ICD insertion reduces sudden cardiac death (SCD) compared to a conservative strategy of ILR insertion and standard care.
* To ascertain the rate of SCD in patients with DCM and LGE scar across a wide range of left ventricular ejection fraction (LVEF).

Statistical analysis will be performed on an intention-to-treat basis. The main analysis of time to death from any cause will be performed using a log- rank test.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than/equal to 18 years old
* Non-ischemic cardiomyopathy of dilated type
* Left Ventricular Ejection Fraction \< 45%
* Able and willing to comply with all pre, post and follow-up testing and requirements
* On maximum tolerated doses of angiotensin converting enzyme (ACE) inhibitors (or Angiotensin Receptor Blockers(ARB) or Neprilysin Inhibitors) and Beta Blockers

Exclusion Criteria:

1. Known coronary artery disease (CAD) (History of Myocardial Infarction or Significant Epicardial CAD on Angiography)
2. Hypertrophic Cardiomyopathy
3. Cardiomyopathy related to sarcoidosis
4. Arrhythmogenic Right Ventricular Dysplasia
5. Standard LGE CMR contraindications (e.g. severe claustrophobia, metal)
6. Currently implanted permanent pacemaker and/or pacemaker/ICD lead
7. Clinical indication for ICD or pacemaker or Cardiac Resynchronisation Therapy
8. Contraindications to intravenous Gadolinium
9. Severe renal insufficiency (eGFR\< 45mls/min/1.73m2 )
10. New York Heart Association Heart Failure functional class IV
11. Conditions associated with life expectancy \<1 year
12. Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception