cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into Patients With Multiple Sclerosis

The intent of this clinical study is to answer the questions:

1. Is the proposed treatment safe
2. Is treatment effective in improving the disease pathology of patients with Multiple Sclerosis and clinical outcomes?

This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (ASC) implantation performed intrathecally and intravenously. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females between Age 18 and 80 years.
* Duration of disease: \>5 years
* Failure to respond or intolerance to the currently available Multiple Sclerosis (MS) immunomodulatory treatments (ie interferons, Copaxone, immunosuppression): the lack of response to these treatments will be determined/defined by either an increase (deterioration) of at least one degree in the Expanded Disability Status Scale (EDSS) score during the last year or the appearance of at least two major relapses of MS during the same period of time (under treatment) or intolerance to these agents.
* Up to date on all age and gender appropriate cancer screening per American Cancer Society .

Exclusion Criteria:

* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease. For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Systolic blood pressure (supine) ≤90 mmHg;
* Resting heart rate \> 100 bpm;
* Active clinical infection.
* Cerebrovascular accident within 6 months prior to study entry
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Unwilling and/or not able to give written informed consent.
Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber

The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.

A Phase I, randomized, double-blind crossover study of CAL-101, an oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta, in patients with allergic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> or = 18 and \< or = 55 years
2. Has a history of seasonal allergic rhinitis for at least 2 years
3. Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
4. Has a positive Radio Allergen Sorbent Test (\> or = class 2) for grass pollen during the previous 12 months or at screening
5. Is otherwise healthy, that is, free from clinically significant illness or disease as determined by medical history, physical examination and laboratory tests, including a normal 12-lead electrocardiogram (ECG)
6. Has no conditions which would make the subject unlikely to be able to remain in the allergen challenge chamber for 4 hours
7. Is available to complete all study procedures
8. Is able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

1. Is a female of childbearing potential (non-childbearing potential means documented surgery resulting in infertility or postmenopausal with no menses for at least 1 year)
2. History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
3. History of nonallergic rhinitis, chronic sinusitis or severe asthma
4. Has a nasal condition likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases
5. Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies, e.g. St. John's Wort. Paracetamol (\< or = 2g/day) and as needed use of short-acting B2-agonists are allowed.
6. Has taken a prohibited medication within the specified interval prior to Visit 1:

   * Corticosteroids (depot, 90 days; systemic, 30 days; dermatologic 14 days)
   * Chromones (14 days)
   * Antihistamines (nasal and long-acting oral, 10 days; shorting-acting oral, 2 days; ocular, 3 days)
   * Decongestants (3 days)
   * Leukotriene modifiers (10 days)
   * Anticholinergics (7 days)
   * Opthalmic nonsteroidal
   * anti-inflammatory drugs (3 days)
   * Nasal-ophthalmic wash solutions (12 hr)
   * Immunotherapy (12 hr)
7. Is currently being treated with a medication that induces or inhibits cytochrome P450 (CYP)3A
Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography

The aim of this study is to demonstrate the value of music in infertile patients undergoing hysterosalpingography on patients' level of pain and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Infertility; patients aged 19 to 42 years; candidate for hysterosalpingography.

Exclusion Criteria:

* Severe dysmenorrhea; pelvic infections; drug sensitivity; unwillingness to participate in the study; presence of psychiatric disorders, use of psychotropic medications; secondary infertility.
Handheld Technology for Speech Development in Students With Autism

The proposed study will result in a software application compatible with the Apple iPad, iPhone and iPod Touch (hereafter termed "iOS devices") which addresses several aspects of prosodic deficits common in speakers with Autism Spectrum Disorders (ASDs) and other communication disorders, using a developmentally appropriate, intuitive interface that requires little technical skill and which can be managed by educators and parents. The program will contain elements that aid in tracking and maintaining individual student progress records, and will be designed for use in the classroom, at home, and in other environments. This study's intended focus is on the feasibility and usability of the software application.


Eligibility Criteria:
Inclusion Criteria:

* SLPs, in Connecticut Public Schools, who provide intervention to students with autism spectrum disorders.
* Students, ages 4 - 19, who attend school in Connecticut and demonstrate prosodic difficulties secondary to a diagnosis of ASD.

Exclusion Criteria:

* Students with concommitant genetic disorders
Expanded Access for BLZ-100 (Tozuleristide)

This is the Blaze Bioscience expanded access program for its investigational drug tozuleristide intended for patients with life-threatening diseases or conditions who have exhausted approved treatment options and are unable to participate in a clinical trial involving the investigational drug tozuleristide.

1. Contact Information: A licensed treating physician may submit questions or requests on behalf of a patient regarding expanded access to tozuleristide to be evaluated in accordance with Blaze Bioscience company policies. Physician Expanded Access Requests should be submitted in writing to expandedaccess@blazebioscience.com and include "Expanded Access Request" in the subject.
2. Request Procedures:

   1. General Criteria: Blaze Bioscience will evaluate and respond to each Expanded Access Request individually and on a case-by-case basis. Criteria Blaze Bioscience will use in its evaluation of whether to grant Expanded Access Request include:

      1. Adequate supply of the investigational drug tozuleristide must be available above and beyond the supply needed for Blaze Bioscience clinical trials;
      2. There is sufficient clinical data to identify an appropriate dose of the investigational drug;
      3. There is a good understanding of the patient's clinical situation and investigational drug proposed use for surgery including the proposed fluorescence detection device;
      4. All available therapeutic approaches for the patient's disease have been exhausted by the patient and their physicians;
      5. The investigational drug is considered an "eligible investigational drug" under Section 561(B)(2) of the FDCA at the time of the Expanded Access Request;
      6. Providing the investigational drug is compliant with all applicable rules and laws;
      7. Appropriate Institutional Review Board/Ethics Committee and FDA authorization requested expanded access has been obtained;
      8. Treating physician understands and is willing to be responsible for ensuring that the patient informed consent requirements are met; and
      9. Treating physician understands and is willing to be the holder of a treatment IND with FDA.
   2. Timing of acknowledgement: Blaze Bioscience endeavors to acknowledge requests within ten (10) business days of receipt of an Expanded Access Request.
   3. Clinical trials: Blaze Bioscience lists its active clinical trials on clinicaltrials.gov. Before granting an Expanded Access Request for tozuleristide, written confirmation by the treating physician that the patient is not eligible for an active Company clinical trial is needed prior to consideration of the Expanded Access Request.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery for suspected or confirmed tumor
* Not eligible for current clinical trials of tozuleristide
A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India

The reason for this study is to see if insulin glargine is safe in participants with type 2 diabetes mellitus (T2DM) in India.


Eligibility Criteria:
Inclusion Criteria:

* Have T2DM based on the disease diagnostic criteria from the World Health Organization (WHO) classification for at least 6 months before screening.
* Have been receiving glucagon-like peptide-1 receptor agonist (GLP-1 RA) or ≥2 oral antihyperglycemic medication (OAMs) at stable doses for 90 days prior to screening.
* Have an HbA1c level ≥7.0% and \<11.0%.
* Have never been treated with insulins except for short term treatment of acute conditions up to a maximum of 14 days.

Exclusion Criteria:

* Have any form of diabetes other than T2DM.
* Have hypersensitivity to the active substance of LY2963016 or to any of the excipients.
* Have any clinically significant disorder, other than T2DM, that in the investigator's opinion, would preclude participation in the trial.
* Are receiving systemic glucocorticosteroids therapy or have excessive insulin resistance (total insulin dose \>2 units per kilogram).
* Have a history or diagnosis of human immunodeficiency virus infection, hepatitis B and C.
* Have comorbidities of unstable angina, cardiac failure (Stage III or IV as per New York Heart Association guidelines) or renal failure (estimated glomerular filtration rate \<30 milliliters/minute/meter squared).
* Are pregnant or intend to become pregnant during the course of the study; or are sexually active women of child-bearing potential not actively practicing birth control by a medically acceptable method as determined by the investigator.
* Is a woman who is breastfeeding.
* Have participated within the last 30 days in a clinical trial involving an investigational product other than the LY2963016. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
* Have previously completed or withdrawn from this study or any other study investigating LY2963016. This exclusion criterion does not apply to participants who are rescreened prior to baseline visit.
* Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Are unwilling or unable to comply with the use of a glucometer.
Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder

To clarify the efficacy and safety of protein A immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(NMOSD), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with NMOSD. We plan to treat patients with acute NMOSD using protein A immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. The aim is to observe the impact and safety of protein A immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of NMOSD, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of NMOSD.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the study are as follows:

  1. clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
  2. Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.
  3. Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.
  4. Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis.
3. Participants with contraindications to intravenous methylprednisolone treatment.
4. Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months.
5. Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use.
6. Severe Bleeding or Bleeding Disorders
7. Severe Heart Failure
8. Severe Infections
Diagnostic Value of C-reactive Protein and White Blood Cell Counts for Early Detection of Inflammatory Complications After Open Resection of Colorectal Cancer

Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive protein (CRP) and white blood cell counts (WBC) in the postoperative course. The aim of this study was to evaluate the diagnostic accuracy of CRP and WBC for postoperative inflammatory complications after open resection of colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* all patients with resection of colorectal cancer

Exclusion Criteria:

* lack of measurement of C-reactive protein
* lack of measurement of white blood cell counts
Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder

This study evaluates the addition of light therapy with LUMINETTE device to usual treatment (antidepressant drug and psychotherapy) in the treatment of Major Depressive Disorder (MDD). Half of the participants will receive active light therapy with LUMINETTE device while the other half will receive placebo light therapy with LUMINETTE placebo device.

Major depressive disorder (MDD) is a world wide spread disorder. According to the World health organization, MDD affects more than 300 million people of all ages in the world. Treatments of MDD include pharmacological treatment and psychotherapy. Pharmacological treatments, mostly serotonin selective reuptake inhibitors, have a delayed onset of action, require long-term treatment and have partial efficacy. In fact, only one third of patients respond to the first antidepressant treatment and two-third after multiple trials. So, there is a need for new treatment strategy.

Light therapy is a well established non pharmacological treatment of seasonal affective disorder, a clinical subtype of affective disorder characterized by recurrent episodes of depression occurring with a seasonal pattern. Patients are exposed to artificial light for a variable duration and intensity. Although the precise mechanism of bright light therapy remains unknown, it is thought to act through the eyes by activating the suprachiasmatic nucleus, the principal circadian pacemaker.

Eligibility Criteria:
Inclusion Criteria:

* MDD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders I-V (DSM-IV), assessed by means of the Mini Neuropsychiatric International Interview (MINI).
* age between 18 and 60 years.
* affiliation with a welfare scheme.
* complete information on the study received and written informed consent signed

Exclusion Criteria:

* diagnosis of a progressive psychiatric disorder (except MDD and anxiety disorder) according to Axis I of the DSM-IV, assessed by means of the MINI.
* absence of routine care for MDD.
* previous or current LT treatment.
* seasonal affective disorder.
* high suicide risk, assessed by means of the MINI
* ongoing neurological disease.
* retinal pathology.
* participation in another study.
* patient impairment leading to difficulty participating or impossibility or inability to understand the information provided on the study.
* persons cited in Articles L. 1121-5 to L. 1121-8 of the French Public Health Code: pregnant women, parturient or breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under duress, persons admitted to a health or social establishment for other goals than research, minors, adults subject to a legal protection, adults who are unable to express their consent and who are not subject to a legal protection measure.
Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy

The estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. Conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure.

The measure of the activity of the autonomous nervous system, and especially the quantification of its variability, is a means to estimate the cardiovascular risk. The investigators formulate the hypothesis that the variability of the autonomous nervous system is an additional clinical element for the evaluation of the evolutionary risk of renal diseases.

The aim of this study is to compare the variability of the autonomous nervous system during the various evolutionary stages of the renal disease.

The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at list 1+) by immunofluorescence.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of IgNA biopsy-proven free, informed, express and written

Exclusion Criteria:

* IgNA secondary to Henoch-Schonlein purpura (HSP) or Systemic Lupus Erythematosus or alcoholic cirrhosis
* current kidney transplantation
* Hypertension treated or not,
* Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy
* diabetes
Defining the Optimal Location to Place an Adductor Canal Block

The aim of the current project is to address a gap in the existing literature related to optimal placement of local anesthetic for an adductor canal (AC) block. The current study seeks to examine whether placement of the local anesthetic in the AC for knee surgery is more effective at reducing post-operative pain following arthroscopic knee surgery compared to a control. Specifically, if the anesthetic is more beneficial than the control group, the research will determine which location is optimal by comparing groups that receive anesthetic in the midpoint of the thigh, the proximal end of the thigh, or the distal end of the thigh.

Although there has been an abundance of literature highlighting the efficacy of using regional blocks to decrease post-operative pain, the exact location of placement of local anesthetic for anesthetizing the nerves in the AC is unknown for optimal pain relief in patients undergoing knee surgery. The saphenous nerve consistently lies in the AC at various points of local anesthetic deposit, however there are many other nerves that lie in the canal that may branch off proximally or distally from the AC that are important to target in achieving optimal pain relief for patients undergoing knee arthroscopy.1-3 The AC is bounded in a triangular shape by the vastus medialis anterolaterally, the sartorius medially, and the adductor longus/adductor magnus posteriorly. The canal contains the deep femoral artery and the deep femoral vein. The saphenous nerve consistently lies within this canal, a significant sensory contributor to the knee.1-3 Other branches of the femoral nerve can also be found in the AC. The nerve to the vastus medialis (NVM) and the posterior branches of the obtruator nerve (PON) can also be found, although inconsistently, in the AC at various locations.4,5 These nerves are thought to innervate the knee as well and contribute to pain when missed during this block. The course of these nerves is unknown. While some surmise that the NVM branches proximally and the PON branches distally, there is no consensus on this.

Currently, an AC block is most often placed in the mid-thigh as measured by visual observation. The investigators seek to investigate where along the tract of the AC would be optimal to place local anesthetic to optimize analgesia on all nerves that innervate the knee without having motor loss as would occur with a femoral nerve block

Eligibility Criteria:
Inclusion Criteria:

* Patient is 7 to ≤ 17 years of age
* Patient at St. Christopher's Hospital for Children
* Receiving a knee arthroscopy procedure
* English speaking

Exclusion Criteria:

* Patient is less than 7 years of age or over 17 years of age
* Patient has cognitive impairments
* Patient had previous operations on the same lower extremity as the current knee arthroscopy
* Patient has a positive B-HCG (identified through urine or blood test)
* Patient does not speak English
MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)

The clinical study evaluates the efficacy and safety of MK0476 in adult patients with allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with seasonal allergic rhinitis

Exclusion Criteria:

* Patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection and those disease severe enough to interfere with assessment of effectiveness
* Patients who have rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilia rhinitis)
* Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease