cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Panobinostat (DACi) Pharmacokinetics and Safety in Solid Tumors and Varying Renal Function

Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and hematological malignancies.

To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with solid tumors and hematological malignancies participating in several phase I/II clinical studies. Panobinostat PK does not appear to be different in patients with solid tumors and hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is yet to be elucidated.

Kidney and liver are involved in the elimination and metabolism of panobinostat. The current study is designed to evaluate the impact of renal function status on panobinostat PK.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has documented diagnosis of advanced solid tumor for which no standard systemic therapy exists
2. Patient has normal or abnormal renal organ function
3. Patient has provided written informed consent prior to any screening procedures

Exclusion Criteria:

1. Patient needing valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose
2. Patient received prior treatment with DAC inhibitors including panobinostat
3. Patient requiring dialysis
4. Patient requiring diuretics unless patient is taking potassium sparring diuretics
5. Patient has acute renal failure, history of transplant, ESRD (however acceptable severe renal impaired group)
6. Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.

Other protocol-defined inclusion/exclusion criteria may apply
Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability

This study aimed to assess the efficacy of hyperbaric oxygen therapy as a neuroprotective intervention in children with acquired brain injury.

Pediatric acquired brain injury (ABI) represents a significant challenge in modern medicine, necessitating innovative therapeutic approaches to enhance recovery and minimize long-term neurological deficits.

Hyperbaric oxygen therapy (HBOT), which delivers oxygen at pressures exceeding atmospheric levels, has emerged as a promising neuroprotective intervention for various forms of pediatric brain injury, including traumatic brain injury (TBI), anoxic-ischaemic encephalopathy (AIE), and stroke.

Eligibility Criteria:
Inclusion Criteria:

* Age 4-12 years.
* Diagnosed with pediatric acquired brain injury confirmed by neurological examination and magnetic resonance imaging.
* Presence of neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infection, stroke, tumor, hypoxia).

Exclusion Criteria:

* Positive family history of degenerative brain insults.
* Behavioral problems.
* Contraindications to hyperbaric oxygen therapy :

  * Active epilepsy.
  * Respiratory insufficiency.
  * Uncontrolled heart failure.
  * Eustachian tube dysfunction.
  * Tympanic membrane rupture.
  * Mechanical ventilation dependency.
Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients. The data from the study should allow for the validation of the Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative CHB patients. As part of a post-approval commitment to the European Health Authorities, the data will also be used to provide an optimized clinical treatment strategy for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from the study will contribute to a better scientific understanding, disease management and treatment of HBeAg negative CHB patients.


Eligibility Criteria:
Inclusion Criteria:

Male or female, at least 18 years of age

Documented compensated HBeAg negative CHB defined by all of the following:

* Detectable serum HBsAg at screening visit and at least 6 months prior;
* HBeAg negative at the screening visit with positive HBeAb;
* Serum HBV DNA \> 2000 IU/mL Serum ALT level \> 1×ULN and \<10×ULN at screening visit; patient with normal ALT ≤1xULN at screening are eligible, with moderate liver inflammation or fibrosis, complensated liver sirrhosis, ALT level \>1xULN wtihin last 6 months

Exclusion Criteria:

* Co-infected with HCV, HDV or HIV.
* Received treatment of nucleoside or nucleotide drugs at any time
* Received IFN or other immunomodulatory treatment within six months before Screening
* Pregnant or nursing (lactating) women
* Clinical signs/symptoms of hepatic decompensation
* History of myopathy, myositis or persistent muscle weakness
* history of clinical and laboratory evidence of chronic renal insufficency
Cell Culture of Glioma Specimens for in Vitro Preclinical Studies

The purpose of this study is to culture primary human brain tumor cells with the specific aims of:

1. Develop primary cultures from human brain tumor surgical specimens
2. Determine the genetic and molecular fingerprints of brain tumors that may have prognostic significance
3. Delineate the mechanisms underlying oncogenesis of brain tumors.
4. Perform in vitro assays with brain tumor derived primary cultures to assess the efficacy of novel therapeutic agents.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older undergoing surgical resection for glioma

Exclusion Criteria:

* Under 18 years of age
Remote Monitoring of CGM Data in Pediatric Patients with Newly Diagnosed Type 1 Diabetes (T1D)

To determine if increased targeted contact between patients and the care team can improve diabetes outcomes in the 1st year after diagnosis. We will be using the GluVue platform to remotely view continuous glucose monitor (CGM) data.

Based on alerts from GluVue, care team members will proactively reach out to patients and their families for more frequent dose adjustments. We will assess if remote monitoring facilitates contact between the care team and patients and improves glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* All individuals within one month of T1D diagnosis seen at the Stanford Children's Diabetes Clinic
* Individuals who plan to receive follow up care at the Stanford Children's Diabetes Clinic
* Individuals who agree to CGM data integration into the electronic medical record (EMR) for remote monitoring
* Age: birth to \< 21 years of age

Exclusion Criteria:

* Diabetes diagnosis other than T1D
* Diagnosis of diabetes \> 1 month prior to initial visit
* Individuals with the intention of obtaining diabetes care at another clinic
* Individuals who do not consent to CGM use, CGM data integration, or remote monitoring
* Individuals \> 21 years of age
Horton & Maizy Pilot Study for Resistant to Starch

This is a pilot study and will be used to power an NIH grant application on the effect of resistant starch on weight gain in children.

Stool fatty acids and stool pH from the baseline and week 4 stool samples will be compared by paired-t test. The stool microflora changes will be reported using descriptive statistics for the percent changes in the different bacterial phyla.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female between the ages of 5 and 15 years

Exclusion Criteria:

* Gastrointestinal disease
* Medication such as antibiotics that have the potential for altering the gut bacterial flora.
* Allergic to milk or corn products.
Cross-sectional Study of Ultrasonic Diagnosis of Iliac Joint Capsule Muscle

In order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound Doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship

In order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound Doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship.Ultrasound was used to compare the size of the iliac joint cystic muscle in the three groups: patients with developmental dysplasia of the hip (DDH), patients with Pincer type femoral hip impingement, and normal control group. The shear wave velocity and shear modulus of the iliac joint capsular muscle of three groups were compared to compare the degree of fat infiltration in muscle.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 20 years;
* Clinically suspected of DDH or Pincer and underwent surgery
* Understand and sign the informed consent

Exclusion Criteria:

* Leggcalve´-Perthes disease
* Muscle diseases
* Hip development disorder
* History of progressive osteoarthritis
* History of hip surgery
* History of arthritis of the hip joint
* With pacemaker or metal in the body
Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD
* Concurrent use of cholinesterase inhibitor or memantine allowed, if stable
* Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria:

* Significant neurological disease other than AD
* Major psychiatric disorder
* Contraindication to undergo brain MRI \[e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body\]
* Women of childbearing potential
Analysis of 2560 Theses

Thesis publication rates in our country, according to research other medical branches; in psychiatry thesis % 37,4; Family Medicine, an increase of 0.9%; in emergency medicine and 7.3% in public health 1.5%; in microbiology %4,2; 5.7 percent in urology; brain surgery was 6.8%; general surgery 5%; 3.8% in eye diseases and surgery; ear, nose and throat diseases and surgery, in %4,2 as has been reported.


Eligibility Criteria:
Inclusion Criteria:

* the keywords" anesthesiology and reanimation"
* Made between 2000 and 2018,
* theses whose complete data can be accessed and allowed to be accessed by authors over the internet

Exclusion Criteria:

* theses whose complete data can be accessed and whose access is not allowed by the authors over the internet.
Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer

RATIONALE: Reflexology and aromatherapy massage may lessen symptoms in patients with cancer. It is not yet known whether reflexology is more effective than aromatherapy massage in relieving symptoms in patients with cancer.

PURPOSE: This randomized clinical trial is studying reflexology to see how well it works compared with aromatherapy massage in relieving symptoms in patients with cancer.

OBJECTIVES:

Primary

* To determine whether reflexology is as effective as aromatherapy massage for alleviation of self-selected symptoms in patients with cancer in an outpatient setting.

Secondary

* To determine the difference between the two therapies with respect to Visual Analogue Scale (VAS) relaxation scores before and after each treatment.

OUTLINE: Patients are stratified according to gender (male vs female), treatment (chemotherapy vs other) and their first concern choice (pain vs other). Patients are randomized to 1 of 2 intervention arms.

* Arm I (Reflexology): Patients undergo 45-60 minutes of reflexology for 4 sessions.
* Arm II (Aromatherapy massage): Patients undergo 45-60 minutes of of aromatherapy massage for 4 sessions.

Patients complete questionnaires (Measure Yourself Concerns and Well-being \[MYCAW\] questionnaire and Visual Analogue Scale \[VAS\]) at baseline, before and after each session, and after completion of all four sessions.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Any patient receiving treatment for cancer at the Royal Marsden NHS Foundation Trust Hospital

  * Must be attending the hospital as an outpatient
* Planning to access complementary therapy

PATIENT CHARACTERISTICS:

* No excessive pain in both hands and both feet
* Not experiencing a combination of conditions affecting both hands and both feet which would prevent reflexology of either hands or feet from taking place, including any of the following:

  * Deep vein thrombosis
  * Lymphedema
  * Infected or broken skin
  * Recent scars or injuries
  * Phlebitis
  * Areas currently receiving radiotherapy (or received radiotherapy in the past 2 weeks)
* Able and willing to attend the hospital for four 1-hour sessions

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 2 months since prior and no other concurrent massage therapy or reflexology at the Royal Marsden NHS Foundation Trust Hospital or from another practitioner
* Not planning to undergo massage therapy or reflexology while also taking part in this study
* At least 2 months since prior and no other concurrent massage therapy at the Royal Marsden NHS Foundation Trust Hospital
Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft

Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.


Eligibility Criteria:
* Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.
A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)

This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety Disorder.

Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have completed all phases of one of the four preceding double-blind GAD studies.
* Female must continue to use adequate birth control methods and have a negative serum pregnancy test within 14 days prior to starting open label treatment.

Exclusion Criteria:

* Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsor's medical monitor.
* Individuals who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsor's medical monitor, would make it unsafe for the subject to participate in the study.
* Serious suicidal risk per the clinical investigators's judgement.
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.

Research study which involves the use of a combination of an Enriched Hematopoietic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow the body to develop "tolerance" to the transplanted kidney. Tolerance means that the body would see the transplanted kidney as part of the patient and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
* Meets the transplant criteria by the study site and both the recipient and donor have been accepted as candidates for standard of care living kidney donation and transplantation
* Patient is receiving a renal transplant only
* The crossmatch is negative between donor and recipient. An initial crossmatch will be performed prior to stem cell mobilization to determine if subject can proceed with the apheresis.
* Potential recipients who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception for 1 year following FCRx infusion
* Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving G-CSF
* No evidence of donor-specific antibody presently or historically
* Panel Reactive Antibody (PRA) less than or equal to 20

Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four-hour drive, for the first month of the protocol so that they can be monitored closely in the early post-transplant period.

Exclusion Criteria:

* Clinically active bacterial, fungal, viral or parasitic infection
* Pregnancy
* Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant or FCRx infusion
* Previous radiation therapy at a dose which would preclude Total Body Irradiation (TBI)
* Positive crossmatch between donor and recipient
* Evidence for immunologic memory against donor
* Body Mass Index (BMI) \>35 or \<18
* Positive serologies for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), human immunodeficiency virus (HIV)
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety

A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject between the ages of 18 and 45 years.
* Subject with a body weight of ≥50 kg and ≤ 75kg and a BMI between 19.0\~26.0 kg/m2 (both inclusive).

Exclusion Criteria:

* subject has a medical history and/or current presence of disease
* subject has undergone surgery within three months before signing the informed consent;
* Alcoholics or regular drinkers within 3 months before the test, i.e. those who drink more than 14 unites of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol), or whose alcohol breath test is positive;
* Those who have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior the trial; those who have positive drug abuse test results;
* Those who smoke more than 10 cigarettes per day on average in the 6 months before signing the informed consent; or those who have positive nocotine results;
* Those who have a history of drug or food allergy, or who have special allergy history (asthma, urticaria, etc.); those who have allergic rhinitis, or are known to be allergic to any component of the test drug or latex (contained in the syringe needle cover);
* Those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 ml) every day;
* Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Traditional Chinese medicine, etc.) and health care products within 4 weeks befor signing the informed consent;
* Those who have a blood donation over 400 ml within 3 months, or 200 ml within 1 month before signing the informed consent, or plan to donate blood during the trail;
* Those who accept any biological drugs within 3 months, or anti-IgE biological drugs within 12 months before signing the informed consent;
* Those who plan to donate sperm within 6 months after the administration of the test drug;
* Participants in other clinical trails within 3 months before signing the informed consent;
* Any one of HIV antibody, HBsAg, HBeAg, HBcAg, HCV antibody and Treponerma pallidum antibody is positive;
* The results of medical examination (ECG, X-ray, B-ultrasonic, physical and laboratory examination) are clinical significant abnormalities according to the judgment of the researcher;
* Anti-nuclear antibody or fecal parasite test is positive;
* Those who have undergone surgery within 1 months before signing the informed consent, or plan to undergo surgery during the trail period;