cyrilzakka/clinical-trials huggingface dataset:
Study of Metabolic Syndrome in Young Patients Who Are Acute Lymphoblastic Leukemia Survivors and Their Healthy Siblings

RATIONALE: Gathering information about metabolic syndrome from young patients who have survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease.

PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have survived acute lymphoblastic leukemia and in healthy sibling volunteers.

OBJECTIVES:

* Determine the prevalence of the metabolic syndrome (MS) and its component traits (i.e., obesity, hypertension, dyslipidemia, and insulin resistance) in survivors of childhood acute lymphoblastic leukemia and in healthy sibling volunteers.
* Identify host- and treatment-related risk factors for MS.

OUTLINE: This is a multicenter study.

Patients' medical charts are reviewed and patients undergo anthropometric measuring (height and weight for BMI calculation and waist and hip circumferences) and blood pressure testing. Patients also complete questionnaires on their physical activity, diet, and family history over 30-45 minutes. Blood is collected to measure cytokines (e.g., adiponectin, leptin, interleukin-6, and C-reactive protein), fasting glucose, and fasting insulin.

Healthy volunteers undergo anthropometric measuring and blood pressure testing (if they are seen in the clinic). They also complete a baseline medical history and questionnaires on their physical activity and diet.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Meets one of the following eligibility criteria:

  * Childhood acute lymphoblastic leukemia survivor

    * Less than 22 years old at diagnosis
    * Treated from 1990-2007 at one of the following locations:

      * Fred Hutchinson Cancer Research Center and/or Children's Hospital and Regional Medical Center in Seattle, WA
      * Vanderbilt Children's Hospital in Nashville, TN
    * Meets 1 of the following treatment criteria:

      * Completed conventional therapy ≥ 11 months ago and in first complete remission
      * Received an allogeneic hematopoietic cell transplantation ≥ 11 months ago and in complete remission
    * No evidence of recurrent disease
  * Healthy volunteer

    * Full sibling of enrolled cancer survivor
    * Age 8-21 (if more than 1 eligible sibling, sibling of closest age is preferred)
    * No history of cancer

PATIENT CHARACTERISTICS:

* Able to speak, read, and write English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No active treatment for graft-vs-host disease

Exclusion Criteria:

* Lack of ability to speak, read, and write English
* Active treatment for graft versus host disease
Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 18-55
* Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, inclusive

Exclusion Criteria:

* Subject has a known hypersensitivity to any of the inactive ingredients of the study treatments.
* Subject has any other condition which, in the Investigator's opinion will interfere with the study.
* Subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.
Ultrasound and Biomarker Tests in Predicting Cancer Aggressiveness in Tissue Samples of Patients With Bladder Cancer

This research trial studies two types of tests, an ultrasound test and a biomarker test, to see how well they predict how aggressive (invasive) bladder cancer is in samples from patients with bladder cancer. The aggressiveness of a tumor means how likely it is to invade the body and spread. The ultrasound test uses a fluorescent dye and stimulates cells under a microscope to see how they respond. This may allow doctors to predict how likely the cancer cells are to spread in the body. The biomarker test uses laboratory testing of samples from patients to study genes and other molecules that may predict the cancer invasiveness. Comparing two different ways of predicting cancer aggressiveness may help doctors identify how well they work, and may eventually allow doctors to predict aggressiveness without needing to take a biopsy.

PRIMARY OBJECTIVES:

I. To establish an association between bladder cancer disease stage and the level of invasiveness as measured by a novel ultrasound assay.

II. To establish an association between bladder cancer disease stage and expression of novel invasiveness biomarkers related to the RE1-silencing transcription factor (REST) gene.

OUTLINE:

Previously collected tumor tissue samples, bladder washings, and urine cells are stained with calcium dye, washed and immersed in external buffer solution, and then transferred to the ultrasound imaging system. Tissue, bladder wash cells and urine cells samples are also analyzed for biomarkers of invasiveness derived from or related to REST gene via quantitative reverse transcriptase polymerase chain reaction (qRT-PCR), Western blot, and fluorescence in situ hybridization (FISH).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of UCC, having one of the stages (Ta, Tis, T1, and T2 or higher)
* Patients with UCC who are undergoing a standard procedure to remove cells/tissue from their bladders (cystoscopy, biopsy, or surgery)
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients who have had chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Establishment of Scoring Model for Early and Differential Diagnosis of Intrahepatic Cholangiocarcinoma

The purpose of this study is to develop and validate a radiological nomogram including radiological characteristics, clinical risk factors, and medical history. And we aim to establish a noninvasive method for the diagnosis of intrahepatic cholangiocarcinoma (ICC), and to construct a differential diagnosis model for ICC and hepatocellular carcinoma (HCC) with higher sensitivity and accuracy.

In recent years, the incidence and mortality of intrahepatic cholangiocarcinoma (ICC) have been increasing worldwide. Due to the different treatment options for hepatocellular carcinoma (HCC) and ICC, accurate differential diagnosis is critical for subsequent treatment of patients. However, because of their similar CT image enhancement patterns, they are easily misdiagnosed by clinicians, leading to an incorrect treatment. Based on the above research background, our objective is to establish a noninvasive method for the diagnosis of ICC and and to construct a differential diagnosis model for ICC and HCC with higher sensitivity and accuracy.

Eligibility Criteria:
Inclusion Criteria:

1. patients with pathological confirmation of ICC or HCC,
2. CT was performed less than 15 days before surgery,
3. Patients with complete clinical data.

Exclusion Criteria:

1. history of other tumors,
2. Metastatic liver cancer,
3. Patients received preoperative chemotherapy or radiotherapy,
4. Image quality analysis is not ideal.
Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects

The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.

Large superficial colonic polyps are increasingly detected thanks to colorectal cancer screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps.

Nevertheless, several adverse events affect ESD, especially in the colon. They could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs.

Thus, preventing these adverse events is an important clinical and medico-economic objective. Endoscopic closure of post-ESD defects could reduce this risk. However, closing these large defects with conventional clips can be difficult, unsuccessful and prolong the duration of the whole procedure. A new trough-the-scope suturing system could successfully provide a complete endoscopic closure of post-ESD defects in the colon in a reasonable time.

Expected benefits are a decrease of morbidity and costs related to colonic ESD procedure

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from 30-60 mm colonic polyps with indication of ESD
* Male or female patients aged \> 18 years' old
* Patients able to fill in questionnaires written in Italian

Exclusion Criteria:

* Failure of endoscopic resection
* Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)
* Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
* Polyp inside the ileo-cecal valvula.
* Rectal lesions
Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease

This study aims to compare efficacy and safety of tacrolimus/methotrexate with cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic hematopoietic stem cell transplantation patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hematological malignancy
* Age under 18 years old
* Serum bilirubin less than 1.5 X upper limit of normal
* Aspartate transaminase, Alanine transaminase less than 2.5 X upper limit of normal
* Alkaline phosphatase less than 2.5 X upper limit of normal
* Serum creatinine less than 1.5 X upper limit of normal
* Agrees to participate, and informed consent signed

Exclusion Criteria:

* Evidence of HIV infection
* Documented uncontrolled disease (infections)
* Prior transplantation (hematopoietic stem cell or solid organs)
Immediate Loading Versus Delayed Loading in Single-implant

The purpose of this prospective randomized clinical study was to compare implant survival, patient satisfaction, and radiographic, clinical, and aesthetic outcomes following immediate loading (IL) and delayed loading (DL) of single dental implants after 1,3 and 5 years of follow-up.

Purpose: The objective of the present prospective randomized clinical study was to compare the overall treatment outcome following immediate loading (IL) and delayed loading (DL) of single implants after 5 year of follow-up.

Patients with a missing maxillary tooth (15-25) were randomly assigned to IL or DL. The protocol included implant installation in healed sites, immediate loading, delayed loading, temporary screw-retained restoration, and replacement with a permanent single implant crown. Outcome measures were implant survival, marginal bone level, soft tissue changes, papillae index, pink, and white esthetic score (PES and WES), patient judged aesthetics, and oral health impact profile (OHiP-14).

Eligibility Criteria:
Inclusion Criteria:

* Patients of at least 18 years of age.
* In need of one or more single-tooth replacements.
* The single-tooth replacement needs to be in the anterior maxilla
* Minimum of mesial-distal width of interdental space of 6 mm

Exclusion Criteria:

* General contraindications for oral surgery
* Inadequate oral hygiene
* Insufficient bone volume at the recipient site
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss

We recently developed a new Neuro-immersion system based on virtual reality and 3D (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. Unfortunately, there is currently no suitable support to compensate for these localization deficits. However, the discomfort felt by the patients is clearly verbalized.

Thanks to the new virtual reality system, we are now able to develop a training protocol based on spatial sound localization tasks.


Eligibility Criteria:
Inclusion Criteria:

For all participants (patients and normal hearing adults):

* Ages 18 and 65
* Normal vision (with or without correction)
* Able to understand experimental instructions
* Member of the social security scheme
* Informed of the study and signed the consent form

For hearing standards (NH):

- No hearing problems

For patients (SU, uIC and bIC):

* Regular follow-up in the ENT (Ear, nose, and throat) department of the Edouard Herriot Hospital in Lyon or the Purpan Hospital, in Toulouse
* Unilateral deep deafness (only for SU patients)
* Holder of one Cochlear implant for more than one year (only for uIC patients)
* Holder of the second Cochlear implant for more than one year (only for bIC patients)

Exclusion Criteria:

* Oculomotor disorder
* Bilateral vestibular areflexia
* Neurological and/or psychiatric history
* Person placed under legal protection, guardianship or trusteeship
* Pregnant or nursing woman
Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris

This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acne vulgaris on the face
* No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study
* Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weather, such as wind or cold, throughout the study
* If male, willing to maintain routine shaving regimen for the duration of the study and avoid shaving 12 hours prior to specified visits
* Females of childbearing potential must use a reliable method of contraception

Exclusion Criteria:

* Use of phototherapy devices (eg, ClearLight™) and adhesive cleansing strips (eg, Ponds® and Biore®), as well as cosmetic procedures (eg, facials, peeling, and comedone extraction) in the area to be treated in the past 1 week
* Use of topical anti-inflammatory drugs, salicylic acid (eg, Clearasil® and Clean \& Clear®), corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products \[eg, benzamycin\]), retinoids, and other topical acne treatments (eg, photodynamic therapy, laser therapy, and medicated soaps) in the area to be treated in the past 2 weeks
* Ability to abstain from caffeine-containing products on the dates instructed
Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)

Primary Objective: Evaluate the user experience with the Stella (TM) app for the management of Postpartum Depression in an observed population for 8 calendar weeks.

Women between 18 and 50 years of age who have had a live birth within 4 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 65 women residing in the state of New York, New Jersey and Connecticut will be recruited to participate in the study. Patient reported outcomes of mild to moderate depression (using EPDS) will be verified by a behavioral health therapist using the Hamilton Depression Rating Scale (HAM-D).

Eligibility Criteria:
Inclusion Criteria:

1. Participants residing in the states of New York, New Jersey or Connecticut and must be able to read, write, and speak English, and provide written informed consent prior to enrollment
2. Participants must be between 18 and 50 years of age
3. Participants must have given live birth within the 4 months prior to the start of study
4. Participants diagnosed with mild to moderate postpartum depression (as assessed by a clinician upon enrollment) and have scored between 9 and 21 on the Edinburgh Postnatal Depression Scale (EPDS) during screening
5. Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (Question #10)
6. Participants must be willing to use a mobile app and own an iOS enabled mobile phone
7. Participants must have wireless internet connectivity in the home and be willing to connect devices to their home Wi-Fi network.

Exclusion Criteria:

1. Participants who do not reside in the states of New York, New Jersey or Connecticut
2. Participants who are not able to read, write, and speak English, and provide written informed consent prior to enrollment
3. Participants less than 18 and more than 50 years of age
4. Participants who have not given birth within the 4 months prior to the start of study OR did not have a live birth in the last 4 months
5. Participants who have not been diagnosed with postpartum depression upon clinical assessment OR do not have a score of between 9 and 21 on the EPDS
6. Participants with a positive (2 or 3) answer on the EPDS self-harm question (Question #10)
7. Participants with Serious Mental Illnesses (SMIs), severe depression, or cognitive impairments
A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL

This is a Phase 1/2 study to test the safety, tolerability, and efficacy of the investigational agent MT-101 in patients with T cell Lymphoma. MT-101 is made with myeloid cells collected from the patient's blood. The myeloid cells are modified and later infused back into their veins. The modified myeloid cells recognize the tumor cells and are designed to target and kill them.

The research study is divided into two parts. The first part will be to determine the safety and tolerability of the study drug product. During this part of the study, there will be 4 groups of study patients. The first group of patients will receive a low dose of cells, the second group will receive the low dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood, the third group will receive a higher dose of cells, and the fourth group will receive the higher dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood. In the second part of the study, cells with or without chemotherapy will be administered based on results of Part 1 and the safety, tolerability, and efficacy of MT-101 will be assessed. All patient groups will receive 6 doses of drug product over 3 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Adults age \> or equal to18 at the time the Informed Consent is signed
* Refractory or relapsed pathologically confirmed T Cell Lymphoma (TCL): Peripheral T cell Lymphoma not otherwise specified (PTCL-NOS) , Angioimmunoblastic T cell Lymphoma (AITL), ALK-negative anaplastic large cell lymphoma (ALCL), ALK-positive ALCL, or Mycosis Fungoides (MF) stage IIB-IV including large cell transformation
* CD5-expressing tumor by IHC or flow cytometry of tumor biopsy within 3 months of Screening or at Screening
* Eastern Cooperative Oncology Group performance status \< 2
* Adequate organ function as defined in the protocol.

Key Exclusion Criteria:

* B1 and B2 disease (as defined in protocol for subjects with MF)
* Known central nervous system involvement by PTCL
* History of allogeneic transplant
* History of intolerance to leukapheresis, plasmapheresis, or blood donation
* Pregnant or nursing women
* Any acute illness including fever (\> 100.4°F or \> 38°C), except fever related to tumor
* Active systemic bacterial, fungal, or viral infection
* Active chronic infection
* Other primary malignancies, except adequately treated malignancies or complete remission
* Active autoimmune disease that has required systemic therapy in the last 2 years
* History of hemophagocytic lymphohistiocytosis
* History of severe, immediate hypersensitivity reaction attributed to penicillin
* Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
Treatment of Severe Depressive Illness by Targeted Brain Surgery

This study will report on the outcome of a clinical program, operational since 1998, that has used surgery targeting an emotional pathway in the brain in the treatment of severe depressive illness that has failed to respond to all other available interventions. Benefit from surgery was anticipated on the basis that the lesion (bilateral anterior capsulotomy) is a well established surgical target for treating severe treatment resistant depression.

Since 1998 bilateral anterior capsulotomy (BAC) has been available to patients in British Columbia Canada who have treatment refractory severe depressive illness. This study will report on the outcome of patients who have received this intervention. BAC is achieved by stereotactic radiofrequency lesioning. To date 8 patients have received BAC. For all patients there is follow-up data of at least 24 months. The purpose of this retrospective study is to report on the surgical protocol and to demonstrate the efficacy and safety of BAC in severe depression.

Eligibility Criteria:
Inclusion Criteria:

* Severe treatment resistant depression of at least 5 years duration
* older than 18 years

Exclusion Criteria:

* Comorbid organic mental disorder
* Delusional disorder
* Substance disorder
* Neurological disease
* Cluster B personality disorder
Effects of Meditation on Mechanism of Coronary Heart Disease

To study the effects of Transcendental Meditation on Coronary Heart Disease

Recent advances in our understanding of the pathophysiology of acute cardiac events - specifically, identification of the roles that arterial vasomotor dysfunction and autonomic nervous system imbalances play in the pathophysiologic cascade during such acute events - provides a platform for new mechanistic investigation of the interplay of psychosomatic stress and CHD (coronary heart disease). Preliminary evidence further suggests that Complementary and Alternative Medicine (CAM) practices, such as the Transcendental Meditation (TM) technique, can not only reduce stress but also reduce acute cardiac events in patients with CHD. Based on these and related data, we propose a randomized, blinded, controlled study of the effects of one CAM practice, the TM technique, compared to a control group, on the primary outcomes of (1) arterial vasomotor dysfunction (brachial artery reactivity); (2) autonomic nervous system imbalances (heart rate variability); (3) transient myocardial ischemia (ST-segment depression); and (4) the secondary outcomes of psychological stress and quality of life (anger, hostility, anxiety, depression, perceived health, disease-specific symptoms, and life stress/social resources).

Eligibility Criteria:
Inclusion Criteria:

* Able to attend training sessions and meetings
* Local residence

Exclusion Criteria:

* Comorbid disease precluding survival in group
* MI, unstable angina, CABG or PTCA within last three months.
* Cognitive/psychological/substance abuse impairment
* Atrial fibrillation, predominant pacemaker rhythm or significant conduction system disease
* Significant valvular heart disease
* Class III or IV heart failure
* Renal failure
* Participating in a formal stress management program
* Participation in another trial