cyrilzakka/clinical-trials huggingface dataset:
Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

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 dactinomycin in treating patients who have persistent or recurrent gestational trophoblastic neoplasia.

OBJECTIVES:

* Determine the efficacy of dactinomycin in patients with persistent or recurrent low-risk gestational trophoblastic neoplasia.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive dactinomycin IV over 15 minutes on day 1. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients who achieve normal beta-human chorionic gonadotropin (HCG) receive 2 additional courses after attaining normal beta-HCG.

Patients are followed every 2 weeks for 2 months and then monthly for 10 months.

PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study within 18-42 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed complete or partial mole on initial evaluation

  * Current diagnosis of persistent or recurrent low-risk gestational trophoblastic neoplasia, defined by 1 of the following criteria:

    * Less than 10% fall in beta-human chorionic gonadotropin (HCG) over 3 consecutive weekly titers
    * More than 20% rise in beta-HCG over the previous value at any time
    * Rise in beta-HCG (greater than 5 mU/mL) after attaining normal level
* Prior treatment limited to methotrexate (MTX) with or without leucovorin calcium (CF)
* WHO score 2-6 at time of relapse
* Must have undergone at least 1 prior curettage for diagnosis and initial management
* No metastatic disease other than lung or vagina on physical examination, chemistry, chest x-ray, or ultrasound
* No more than 8 metastatic lesions
* No histologically confirmed placental site trophoblastic tumor at initial evaluation

PATIENT CHARACTERISTICS:

Age

* 12 to 50

Performance status

* GOG 0-1

Life expectancy

* Not specified

Hematopoietic

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Granulocyte count at least 1,500/mm\^3

Hepatic

* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Alkaline phosphatase no greater than 3 times normal

Renal

* Creatinine no greater than 1.5 mg/dL

Other

* No significant infection
* No more than 1 year since prior pregnancy
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics
* At least 1 week since prior chemotherapy and recovered
* No prior chemotherapeutic drugs other than MTX with or without CF

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* See Disease Characteristics
* Recovered from prior surgery
* No concurrent curettage unless required to control vaginal bleeding

Other

* No prior anticancer treatment that would preclude study therapy
A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis

The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.

Diagnostic procedures like transbronchial lung biopsy (TBLB), transbronchial needle aspiration (TBNA) and endobronchial biopsy (EBB) are routinely used to obtain pathological confirmation of pulmonary sarcoidosis. Real-time convex probe endobronchial ultrasound-guided TBNA (EBUS-TBNA) has shown immense potential, however it is costly, labor intensive and still has limited availability, especially in low and middle income countries. In the past, TBLB has been the bronchoscopic procedure of choice for diagnosis of sarcoidosis however currently its role is being debated with the advent of EBUS. We have observed that EBUS even though has high yield yet the optimal diagnosis is obtained only when combined with EBB and TBLB. The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.

The study compares the diagnostic yield of EBUS-TBNA (plus EBB and TBLB) vs. conventional TBNA (plus EBB and TBLB) for diagnosis of sarcoidosis.

Eligibility Criteria:
Inclusion Criteria:

Consecutive patients presenting with clinicoradiological features suggestive of sarcoidosis and an indication for transbronchial needle aspiration

Exclusion Criteria:

* Pregnancy
* Hypoxemia (SpO2 \<90%) on room air
* Poor lung function (forced expiratory volume in first second \[FEV1\] \<1L)
* Patients with deranged clotting profile (prothrombin time \>3 seconds above control; activated partial thromboplastin time \>10 seconds above control, platelet count \<50000/µL)
* Patients already initiated on glucocorticoids
* Diagnosis of sarcoidosis possible on minimally invasive techniques such as skin biopsy or peripheral lymph node biopsy and failure to provide informed consent
A Clinical Study to Evaluate PK, PD, and PG of Rosuvastatin in the Elderly

A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects aged 65 - 85 years
* A body mass index (BMI) in the range of 18.5 kg/m2 - 27.0 kg/m2.
* Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.

Exclusion Criteria:

* Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets

This is a open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3454 tablets in subjects with advanced solid tumor or hematologic tumor.


Eligibility Criteria:
Inclusion Criteria:

- 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.

2. Advanced solid tumors or hematological malignancy. 3. Adequate laboratory indicators. 4. No pregnant or breastfeeding women, and a negative pregnancy test. 5. Understood and Signed an informed consent form.

Exclusion Criteria:

* 1. Has central nervous system metastasis or system leukemia. 2.Previous anti-tumor treatment:

  1. Has received IDH1 mutation inhibitor.
  2. Has received systemic anti-tumor therapy or radiotherapy within 14 days before the first dose.
  3. Has received oral targeted drugs, less than 5 drug half-lives from first dose.
  4. The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 2, except for hair loss.

     3.Complicated disease and medical history:

  <!-- -->

  1. Active hepatitis B or hepatitis C.
  2. Abnormal kidney.
  3. Abnormal cardiovascular and cerebrovascular.
  4. Abnormal gastrointestinal.
  5. Has medical history of immunodeficiency.
  6. Has bleeding (hemoptysis), coagulopathy, or been using warfarin, aspirin, and other antiplatelet agglutination drugs.
  7. Has uncontrollable systemic bacterial, fungal or viral active infections.
  8. Has medical history of idiopathic pulmonary fibrosis,or tissue pneumonia.
  9. Has allergic constitution or previous severe allergy; or known allergy to ingredients of study drug.
  10. Has neurological or mental disorders.
  11. Has a history of drug abuse or drug addict.
  12. Has received major surgery, open biopsy, or obvious traumatic injury within 4 weeks before the first dose.
  13. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

      4. Has participated in other clinical trials within 30 days before participating in this trial.

      5. Female patients during pregnancy or lactation. 6. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

      7. criteria for solid tumors:

  <!-- -->

  1. Has any signs of bleeding constitution.
  2. Has any CTCAE ≥ grade 3 bleeding or bleeding event,within 4 weeks before the first dose.
  3. Has unhealed wounds, fractures, active ulcers of the stomach and duodenum, ulcerative colitis and other digestive tract diseases.
  4. Imaging (CT or MRI) shows that the tumor has invaded the circumference of important blood vessels.
  5. Has uncontrollable pleural effusion, pericardial effusion or ascites that still need repeated drainage.

criteria for blood tumor:

a) Has severe life-threatening leukemia complications.
Assessing the Impact of a Call Center Providing Standardized Pediatric Advice (PLATEL-EVAL)

In order to show that tailored pediatric counselling by telephone can reduce the number of unscheduled and medically unjustified physicians visits in emergency structures, a randomized controlled study is conducted. It compares the proportion of cases which used the emergency services or unscheduled consultation according to whether they received (or not) nurses' telephone advices from the platform. Indeed, our hypothesis is that the presence of nurses responding at the Reception and Control Calls Center inside the Emergency Medical Services (in french : Service d'Aide Médicale d'Urgence SAMU) - whose role is to deliver appropriate advice to people calling for benign pathologies they see as urgent and to answer questions following specific recommendations - will reduce the number of unplanned and medically unjustified consultations in medical emergency structures.

This platform was set-up in order to show it may be a solution in response to the growing demand for pediatric care from the population, helping to reduce overcrowding in emergency care facilities. Indeed, promoting home care or only if necessary scheduled consultation reinforces the conduct to have when facing a pathology from their child. It will also help by reducing unjustified use of emergency structures, improving not only the users' reception conditions who actually require support in these structures with less waiting time, but also the working conditions for employees who perform there.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are different depending on the subject concerned, for reasons related to risk factors of pediatric diseases. They are audited by the regulator doctor (who has a fact sheet) and are controlled by the nurse of the platform.
* For fever theme, a call is eligible if the child is older than 3 months and under 6 years old, and has had a fever for less than 48 hours.
* For the theme diarrhea, a call is eligible if the child in question is aged from 12 months to 3 years, and has had diarrhea. Fever and vomiting are not exclusion criteria.
* For the theme breathing difficulty, a call is eligible if the child in question is aged from 3 months to 3 years, has experienced discomfort breathing and has shown no fever. Stuffy nose, runny nose and cough are not exclusion criteria.
* For the theme fall with head shock, a call is eligible if the child concerned is a toddler and until the age of 12.
* For the theme crying infant, a call is eligible if the child in question is aged 0-4 months and has been crying. Fever is an exclusion criterion.

Exclusion Criteria:

* Refusal of participation or refusal to be reminded to 7 days,
* Children with impaired general condition and / or behavior change during the call,
* Situation requiring medical attention without delay,
* Lack of understanding of the caller
Nursing Study of Skin Lesions Related to Health Care Protection in Novel Nursing Study of Skin Lesions Related to Health Care Protection in Novel Coronavirus Epidemic

In the fight against the epidemic, medical personnel need to wear protective equipment, such as N95 mask, face screen, goggles, latex gloves, waterproof isolation clothing, and have special requirements. Protection-related skin lesions after the use of protective equipment will affect the health and comfort of medical workers. In this study, a retrospective study was conducted on the front-line medical workers in the fight against COVID-19 using questionnaires, so as to understand the incidence, location and clinical manifestations of skin lesions caused by the use of protective equipment by medical workers. And analyze the causes of these skin damage, so as to develop the corresponding prevention and treatment countermeasures, select 170 cases that meet the research conditions, a randomized controlled experiment, divided into control group and experimental group: the control group is on the basis of three-level protection, did not use any preventive measures of health care workers. In the experimental group, skin related prevention was carried out on the basis of three-level protection. The specific interventions are as follows :(1) Focus on protecting exposed skin and making it locally dry. (2) Do a good job of facial moisturizing before work (at least 1 hour before wearing the mask), use moisturizing ointment, longer lasting and non-irritating cream or emulsion, such as vitamin E cream, Vaseline, avoid direct contact with the skin of the mask, choose the appropriate type of protective device; Reduce friction by sticking foam paste, hydrocolloid accessories, ampute and so on on good hair parts. However, it should be noted that it must be confirmed that the airtightness is good, and the primary purpose of the medical staff is to ensure the protective effect. (4) After work, avoid using irritant (such as hot water, exfoliating cream, etc.) to clean the face, and massage local skin with skin moisturizer; (5) In case of severe skin damage, treat as prescribed by the doctor; (6) After finishing the front-line work, "Questionnaire Star" was used to collect data, and all data were input into the statistical software for analysis to compare the index differences between the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Job post: fever clinic, COVID-19 throat swab sampling site, isolation ward
2. Health care workers who have worked for 30 days or more
3. The continuous working time of tertiary protection shall be more than or equal to 4 hours
4. Signed the informed consent and volunteered to participate in the study.

Exclusion Criteria:

1. Existing long-term skin damage
2. The skin damage related to protection is too heavy to be studied
First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts

This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of topically applied CLS003 in healthy subjects with cutaneous warts.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
* Body mass index (BMI) between 18 and 30kg/m2, inclusive
* Fitzpatrick skin type I-II-III-IV
* At least 4 cutaneous warts on the hands, separated by at least 1cm of skin

Exclusion Criteria:

* For women, a positive pregnancy test and/or nursing at screening
* A positive test for drugs of abuse at screening
* History of alcohol or illicit drug abuse
* Positive test results for Hepatitis B, Hepatitis C or HIV
* Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
* Have received cryotherapy in the treatment area within 60 days prior to enrollment
* Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.
Melatonin for Prevention of Radiation Induced Oral Mucositis

The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.

The study was designed as randomized, controlled, clinical trial. patients who were undergoing chemoradiation were divided into two groups: Group I: was given conventional treatment. Group II: was given melatonin therapy in combination with the conventional treatment.

All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity. in addition, the total antioxidant capacity of the melatonin was evaluated at the start of the radiotherapy and six weeks later.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
* Patients whose radiotherapy treatment planned dose is between 60-70 Gy.
* Patients who had received chemotherapy prior to radiotherapy or are going to receive chemotherapy in concomitant to radiotherapy.

Exclusion Criteria:

* Patients under Anticoagulants such as warfarin, heparin, or aspirin.
* Patients under Fluvoxamine (Luvox) and Nifedipine medications.
* Patients whose radiotherapy treatment planned dose is lower than 60 Gy.
* Pregnant and lactating women.
* Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
* Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate

This study is the first clinical trial using sodium oxybate for the treatment of REM sleep behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has shown to be effective and well tolerated in patients with RBD (Shneerson, 2009; Liebenthal, 2016; Moghadam, 2017).

Rapid eye movement sleep behavior disorder (RBD) is a condition resulting in violent dream-enactment during sleep which affects millions of individuals in the United States, however therapies for RBD are limited and cause significant side effects. As a result, despite using a combination of drugs, a large number of patients with RBD continue to act out violent dreams causing severe self-injuries or injuries to their bed partners. Prior studies and our experience have shown that sodium oxybate can be effective in these cases of treatment-resistant RBD. This study would therefore evaluate the efficacy and tolerance of sodium oxybate in this patient population.

This study is an 8-week trial comparing sodium oxybate versus placebo randomly assigned to patients with treatment-resistant RBD, i.e. individuals who have insufficiently responded or tolerated melatonin and clonazepam. The study uses a double-blind design (participants, staff, and investigators will not know which drug between active drug and placebo is given to participants), and will measure treatment efficacy based on patients, partners and clinicians report, and objective outcomes based on in-home actigraphy and in-lab polysomnography before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* 40-85 years old
* With or without Parkinson's disease
* Experiencing RBD episodes on average at least 2x/week or 8x/month
* Able to report RBD episodes themselves or via a partner witness

Exclusion Criteria:

* History of falls during ambulation in the last 6 months despite adequate neurologic treatment
* Requirement of an ambulatory device at home
* Inadequately treated symptomatic orthostatic hypotension
* BMI \> 35
* Untreated or uncontrolled OSA (4%AHI\>15)
* Cognitive impairment resulting in inability to comply with treatment instructions
* Pregnancy
A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)

This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN


Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic Postherpetic Neuralgia (PHN), defined as pain present for more than 6 months and less than 10 years after onset of herpes zoster skin rash affecting a single dermatome. Patients with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous.
* Patient is ≥18 years of age, with a body mass index (BMI) between 18 and 34 kg/m2, inclusive, at the screening visit.
* If the patient is a woman and is fertile, the patient is not pregnant and has negative pregnancy tests at both the screening and randomization visits, and agrees to use an acceptable method of contraception for the duration of the study, including follow-up.
* If the patient is a man and is capable of producing offspring, the patient must agree to use an acceptable method of contraception, unless the partner cannot become pregnant for the duration of the study, including follow-up.
* Patient must sign the written Informed Consent Form (ICF) for the study and be willing to comply with all study procedures and restrictions.
* Patient must be judged by the investigator to be medically healthy (except for PHN) and able to participate in the study

  * Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Patient has any other severe pain that might confound assessment or self-evaluation of pain due to PHN.
* Patient has PHN affecting the face (trigeminal nerve distribution).
* Patient has a history, in the judgment of the investigator, of inadequate response to more than 3 adequate courses of treatment with other medications used to treat neuropathic pain (eg, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants, topical lidocaine, and/or topical capsaicin).
* Patient is taking oral analgesics (either opioid or non-opioid) or is receiving topical therapy such as the 5% topical lidocaine patch for the treatment of pain and is unwilling or unable to complete a washout period during which the patient will discontinue analgesic therapy or topical pain therapy.
* Patient has been treated with topical capsaicin at any time in the past 6 months for neuropathic pain.
* Patient has a history of fibromyalgia.

  * Other criteria apply, please contact the investigator for more information