cyrilzakka/clinical-trials huggingface dataset:
Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.

The trial of the dose escalation method is from the minimum dose until the maximum tolerated dose and every 3 patient is a dose group.

Eligibility Criteria:
Inclusion criteria:

* Patients must compliance with the requirements and restrictions listed in the consent form
* Patients with Pathology and / or cytologically proven malignant solid tumor
* Patients must be 18-70 years old ,both male and female
* Failure of standard chemotherapy
* Patients have no better choice and may be benefit from the use of anthracyclines
* Patients must have Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2
* Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks
* Expected survival time ≥ 3 months
* Patients agreed to take effective contraceptive measures during the trial
* Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements.

Exclusion criteria:

* Pregnancy and breast-feeding women
* Multiple sclerosis
* Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease
* Patients with heart disease induced by anthracycline
* Patients requiring other antineoplastic treatment
* Patients with temperature above 38 degrees or active infection that may effects in clinical tests
* Patients are allergic to anthracycline and liposomal drugs
* Patients are allergic to eggs,egg products,soybean and soybean products
* Patients with uncontrolled primary or metastatic brain tumors
Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease

The main purpose of this study is to define the molecular profile of selected solid tumors. From each participants will be collected biological materials for molecular analysis, including saliva, blood and vital tumor tissue derived form surgical or biopsy procedures. Whereas possible, vital tumor specimens will be inoculated and propagated in immunocompromised NOD/SCID mice to study the genetic correlations between genetic status and response to target drugs.


Eligibility Criteria:
Inclusion Criteria:

Patients with at least one of the following selected solid tumors:

* Colorectal Cancer (primary or with synchronous/metachronous liver metastases)
* Prostate Cancer
* Head \& Neck Tumors
* Gastric Cancer
* Glioblastoma
* Breast Cancer
* Hepatocarcinoma
* Biliary Tract Carcinoma
* Lung Cancer (primary)
* Rare Tumors (incidence ≤ 5x10-6)
* Metastatic Sarcoma
* Metastatic Melanoma

Exclusion Criteria:

-
A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents during childhood, and is characterized by developmentally inappropriate levels of inattention and/or hyperactive-impulsive behavior. It is proposed that classical homeopathic treatment can reduce the symptoms of ADHD without serious side effects. This is an open label pilot feasibility study (36 participants). Participants, age 6-16, will consult with a homeopathic practitioner who will select treatments based on classical homeopathy principles. All participants will be assessed on a 4-weekly basis for a total of 36 weeks. The purpose of the study is to assess feasibility of recruitment and patient retention, to obtain pilot data on which to base a sample size calculation for future study, and to identify major safety concerns. The study will use single homeopathic medicines approved for over-the-counter use in Canada. The primary outcome measure will be the validated Conners 3rd Edition - Parent.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 6-16 diagnosed with ADHD of any subtype according to DSM-IV criteria.
* Mentally competent participants able to adhere to the given protocol and treatments administered as interventions, and able to answer outcome measures.
* Primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study.

Exclusion Criteria:

* Changes to participants' medication for ADHD within 6 weeks of study onset.
* Diagnosis of additional mental health disorder including but not limited to: Conduct Disorder, Autism Spectrum Disorder, Bipolar Disorder, and Major Depressive Disorder. The patient should not have current suicidal or homicidal ideation.
* Participants should have no history of head injury of seizures, organ system damage and should have an estimated I.Q within the normal range.
* Pregnancy and Lactation
Effects of a Moisturizing Product on Dry Eye and Skin

Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and grittiness of eyes. The objective of this study is to investigate the effects of a moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around the eyes.


Eligibility Criteria:
Inclusion Criteria:

* Dry eye symptoms OSDI score 20 or higher
* Dryness, burning or foreign body sensation moderate or higher

Exclusion Criteria:

* Severe eye diseases
* Known allergy to any of the ingredients of the product
* Laser surgery of eyes during the last year
Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

This is a biomedical study of interventional type, multicenter, inter-regional.

Patients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. The main objective is to estimate the correlations between pharmacokinetic and pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3 years.


Eligibility Criteria:
Inclusion Criteria:

1. Patient of more than 18 years old (menopaused or not)
2. Invasive breast cancer non-metastatic locally controlled by surgery with or without radiotherapy. Previous treatment with chemotherapy is allowed including trastuzumab
3. Cancer hormone-expressing ER and / or PR (\> 10% tumor cells in Technical HIC)
4. Having a staging exploring bone, liver, lung and showing no abnormality secondary (for sub-centimeter tumors, the staging is not necessary)
5. WHO \<2
6. Before the initiation of adjuvant hormonal therapy (tamoxifen, anastrozole, letrozole or exemestane) and whatever the approach chosen by the investigator (5 years of tamoxifen, 5 years of anti-aromatase or sequential patterns)
7. signed Consent collected before any specific procedure in the study
8. Patient member in a national insurance scheme.

Exclusion Criteria:

1. Patient previously treated for breast cancer receiving hormonal therapy with tamoxifen, anastrozole, letrozole or exemestane regardless of the scheme
2. Metastatic Breast cancer
3. History of another cancer diagnosed within 5 years before or uncontrolled except carcinoma in situ of cervix carcinoma, nonmelanoma skin, breast cancer (in this case, treatment with hormone therapy should be stopped for at least 6 months)
4. Any other medical or psychiatric condition or laboratory abnormality severe acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator
5. Patient unable to follow procedures, visits, examinations described in the study
6. Pregnant women or nursing mothers can not participate in the study
7. Women of childbearing age must use effective contraception at study entry and up to at least three months after the end of treatment
8. Patient under legal guardianship
A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA

A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥ 18 years of age
2. Patient with locally advanced or metastatic urothelial carcinoma (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response or complete response) following completion of first-line platinum-based chemotherapy and who has been (retrospective), is (retrospective and prospective), will be (prospective) treated with avelumab.

   * For a patient alive at the moment of the inclusion in the study : the patient must be informed of the study, he/she must be given an information letter signed by the investigator and must not be opposed to the collection of his/her data
   * For a patient who died before the inclusion in the study : the patient (during his life time) must not be opposed in writing to the collection of his data.
3. Patient benefiting from a social security scheme according to local regulations

   Exclusion Criteria:
4. For a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent.
5. Patient enrolled in a prospective interventional clinical trial assessing an investigational product.
Surgical Margin Assessment by 3D Ultrasound

Complete removal of cancer encircled by a secure margin of healthy tissue is the aim of surgical oncology. A close or positive surgical margin reported by pathologist typically ends in adjuvant therapies (re-surgery and/or radiotherapy), which come with prognostic risks and financial cost. Therefore, ex-vivo imaging of removed cancer tissue may assist in margin evaluation. In this study, investigators aimed to investigate the correlation of 3D ultrasound to histopathology to assess tongue tumor margin status.


Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment
* T1-T2 staging on cross-sectional imaging

Exclusion Criteria:

* Age \< 18 yrs
* T3-T4 staging
* Unable to understand the verbal or written information
* Prior radiotherapy treatment of oral cavity cancer
Topotecan in Treating Patients With Recurrent Brain Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with recurrent brain tumor.

OBJECTIVES: I. Determine the efficacy of topotecan in patients with recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma. II. Determine the qualitative and quantitative toxicity of topotecan in this patient population on this schedule.

OUTLINE: This is a multicenter study. Patients receive intravenous topotecan over 30 minutes daily for 5 days every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients will be followed every 3 months until death.

PROJECTED ACCRUAL: Up to 30 evaluable patients will be accrued within 2-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma following primary surgery and radiation therapy Tumors for anaplastic mixed oligoastrocytoma must contain at least 25% oligodendroglial elements Tumors must be clinically aggressive for patients with only 1 anaplastic feature Prior low grade oligodendrogliomas or oligoastrocytomas undergoing repeat biopsy following clinical or radiological progression are eligible Bidimensionally measurable and progressive lesions by CT or MRI

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine normal Other: Not pregnant or nursing Fertile patients must use effective contraception No prior malignancies except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer No other serious illness or medical condition No active uncontrolled infection No history of neurologic or psychiatric disorder

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since chemotherapy No more than 1 prior chemotherapy regimen No prior camptothecin derivatives Endocrine therapy: At least 2 weeks on stable steroid therapy, if necessary Radiotherapy: At least 2 months since prior radiotherapy No prior radiation therapy for recurrent disease Surgery: At least 6 weeks since prior surgery (except biopsy only) Prior surgery for recurrent disease allowed (including stereotactic biopsy or partial resection) Other: No concurrent experimental drugs or anticancer therapy
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis

This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.

A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery Technologies, Inc. at the Walter Reed Army Medical Center. Pentostam is the standard of care for this disease, but the i.v. administration and the many known side effects prompt the search for an improved method of treating this disease, especially for milder cases. This study compares the safety and efficacy of these two treatment approached.

Eligibility Criteria:
Inclusion Criteria:

* Department of Defense (DOD) Healthcare beneficiary
* Parasitologic diagnosis of cutaneous Leishmania infection

(Inclusion criteria for randomization includes that must be Leishmania major species)

* Willing to locate to WRAMC area during treatment and perform subsequent follow-up visits if needed

(If not active duty on orders, then the participant will bear the cost of food and lodging during the initial 10-day outpatient treatment period at Walter Reed Army Medical Center)

* Able to provide informed consent
* All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving sodium stibogluconate

Exclusion Criteria:

* Unable to provide informed consent
* Pregnancy (females of child bearing potential must have negative urine human chorionic gonadotropic hormone \[HCG\] within 48 hours of the start of infusion period)
* History of hypersensitivity to pentavalent antimonials
* Serious medical illness:

  1. QTc interval \>/= 0.5 sec
  2. severe cardiac disease
  3. history of current pancreatitis
  4. liver failure or active hepatitis with transaminases \>3X normal
  5. renal failure or creatinine \>2.5
  6. thrombocytopenia (platelets \<75,000)
  7. white blood cell count \<2000
  8. hematocrit \<25
  9. absence of palpable extremity pulses in the limb requiring treatment
* History of serious allergic reaction to local anesthetics
* Location of lesion not amenable to local therapy (such as close to eye, mucous membranes, face, cartilage)
* Presence of pacemaker and/or other implanted metallic devices
* Breast feeding
* Men unwilling to avoid fathering a child during and/or in the two months following receiving the treatment
* Women unwilling to avoid pregnancy for at least two months after receiving the treatment
* More than 20 lesions, or multiple lesions which in the opinion of the investigator would not be well treated with heat therapy
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)

Primary:

• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo

Secondary:

* To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9
* To evaluate the immunogenicity of AVP-21D9

This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy volunteers, between 18 and 45 years of age
* Normal laboratory (blood test) results

Key Exclusion Criteria:

* Prior immunization with anthrax vaccine
Online Cognitive Behavioral Therapy (CBT) for Stress Disorders in Health Workers Involved in the Care of Patients During the Covid-19 Epidemic

Some preliminary epidemiological research conduct in China in health workers involved in the care of Covid-19 patients has shown high rates of depression (\>50%), generalized anxiety disorder (\>44%), insomnia (\>36%) and stress symptoms (\>73%), which negatively impact their well-being as well as their ability to work effectively . These rates were observed during the epidemic peak, but they can also have a long-term mental health effect, both individually, but also in a systemic manner , similar to what has been reported relative to the SARS-CoV-1 . Cognitive behavioral therapy (CBT) is recognized as an effective treatment for stress-reduction, as well as for the prevention of multiple mental health problems in at-risk individuals . Moreover, CBT has been found to be effective in brief online formats , which could make it feasible during the current Covid-19 epidemic. To our knowledge, there are no online CBT programmes targeting stress problems in health workers involved in the care of patients during the current epidemic context. The aim of our study is to evaluate the efficacy of the online CBT programme we have developped to specifically address immediate perceived stress in health workers, as well as the prevention of mental health problems at 3- and 6-months follow-up


Eligibility Criteria:
Inclusion Criteria:

* Health worker
* Male or Female
* Aged 18-70
* Able to understand the French language

Exclusion Criteria:

* PSS \< 16
* Suicidal ideation assessed as \< 3 on the item 9 of the PHQ-9
* legally able to provide informed consent
Effect of Video Information on the Dental Anxiety Levels of the Endodontic Patients

This study compared the effect of the detailed video visual information and basic verbal information on patients' anxiety levels (using anxiety scales) before endodontic treatment and stress levels (using electrodermal activity method) during endodontic treatment.

Patients (n=120) aged between 18-65 with single-rooted teeth with the single canal that diagnosed with asymptomatic irreversible pulpitis and/or pre-prosthetic root canal treatment were included in this study. Patients were randomly divided into two groups after completing anxiety scales and socio-demographic/dental habits form. Before the treatment, visual video information was given to the video group patients, while the control group patients were routinely informed verbally. The stress levels during the endodontic treatment process were recorded by placing a electrodermal activity measurement device on the wrists of the patients. Anxiety scales and feedback-satisfaction forms were administered to all patients after the treatment process.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18 - 65 years of ages
2. Patients with healthy (ASA 1) and mild systemic disease (ASA 2) according to ASA classification
3. Patients with no mental disorders in their medical history
4. Patients who do not have a psychiatric disorder that they have started, and who do not use psychotherapeutic drugs.
5. Literate and not visually impaired patients
6. Patients presenting with single-rooted teeth with a single root canal diagnosed with asymptomatic irreversible pulpitis or single-rooted vital teeth with a single root canal requiring root canal treatment due to prosthetic reasons

Exclusion Criteria:

1. Patients who refuse to participate this study
2. Patients have existing pain caused by another tooth
3. Patients with dermatological disease in the medical histories
4. Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications)
5. The presence of spontaneous pain, swelling, or fistula in the relevant tooth
6. Teeth whose working length cannot be reached due to calcification and step formation in the root canal
7. The presence of foreign material in the root canal that prevents entry (broken instrument, post)
8. The presence of advanced periodontal disease (probing depth \> 4 mm) or root fracture in the relevant tooth
9. Patients using pain medication on the same day before treatment (within 24 hours)
Water-friendly Virtual Reality and Brief Thermal Pain

Using immersive virtual reality as a form of pain distraction during a brief "painful but tolerable" temperature.

This study will use Quantitative Sensory Testing (computer-controlled brief 10 second thermal pain stimuli) in healthy college students.

The primary aim is to conduct a randomized, controlled study with healthy volunteers to explore whether interacting with virtual objects in VR via a high tech interactive VR system makes VR significantly more effective/powerful compared to a less immersive passive VR system, vs. No VR, for reducing pain during quantitative sensory testing.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
* Able to read, write and comprehend English
* Able to complete study measures
* Willing to follow our UW approved instructions
* 18 years of age or older

Exclusion Criteria:

* People how have already previously participated in this same study (e.g., last quarter) are not eligible to participate again.
* Not enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
* Not be able to read, write and comprehend English
* Younger than 18 years of age.
* Not capable of completing measures
* Not capable of indicating pain intensity,
* Not capable of filling out study measures,
* Extreme susceptibility to motion sickness,
* Seizure history,
* Unusual sensitivity or lack of sensitivity to pain,
* Sensitive skin,
* sensitive feet,
* migraines,
* Diabetes.