cyrilzakka/clinical-trials huggingface dataset:
Device Feasibility and Acceptability to Improve Insomnia in Cancer

Sleep disruption is common among young adult cancer survivors for a variety of reasons. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve chronic sleep disorders. This project will test the feasibility and acceptability of a new voice-activated virtual assistant (VAVA) device to deliver CBT-I to improve sleep among young adult cancer survivors with chronic sleep disorders.

Sleep is a complex biobehavioral event, impacted by interactions between the individual's physiology as well as their environment. Young adult cancer survivors (YACS; those between 18- 29 years of age) are a growing group of survivors, numbering close to 400,000 in the US. They are among those at highest risk for chronically insufficient sleep due to developmentally normative biological and social factors, compounded by their extensive medical treatment history. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended by the American College of Physicians as gold standard treatment for insomnia disorder and has been successfully adapted for YACS. Fundamental CBT-I strategies can be implemented to change the problematic sleep behaviors that result in insufficient sleep among young adults. However, it is essential that these evidence-based strategies be deployed to be responsive to the specific barriers to sleep for YACS. This feasibility/acceptability study will test the use of an integrated VAVA that offers the opportunity to implement intervention strategies in a way that repeatedly gives YACS the chance to make the right decision with respect to their sleep health in real time.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 29 years old
* history of cancer (any type, any stage)
* chronic sleep loss as evidence by self-report of receiving less sleep than recommended for their age by the National Sleep Foundation for \>/= 3 months
* must have an internet router in their primary home that they have access to (can add a second router to for the system to work)

Exclusion Criteria:

* acute medical/psychiatric disorder requiring treatment
* developmental or congenital disorder
* life expectancy \<12 months.
Phase I Clinical Trial of Autologous CD7-CAR T Cell Therapy for High-risk Acute T-cell Leukemia/lymphoma

This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen CD7
2. Refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks
3. Male or female, aged 0-70 years
4. No serious allergic constitution
5. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
6. Have life expectancy of at least 60 days based on investigator's judgement
7. CD7 positive in bone marrow or peripheral blood or immunohistochemistry
8. Candidates aged 8-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. And Pediatric patients under 8 years old could be recruited after signing an informed consent form by a legal surrogate (Guardian)
9. Minimal residual disease was positive after chemotherapy and there were contraindications of allogeneic hematopoietic stem cell transplantation.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Intracranial hypertension or disorder of consciousness
2. Symptomatic heart failure or severe arrhythmia
3. Symptoms of severe respiratory failure
4. Complicated with other types of malignant tumors
5. Diffuse intravascular coagulation
6. Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
7. Suffering from septicemia or other uncontrollable infections
8. Patients with uncontrollable diabetes
9. Severe mental disorders
10. Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
11. Have received organ transplantation (excluding hematopoietic stem cell transplantation);
12. Reproductive-aged female patients with positive blood HCG test
13. Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis
Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

To assess TCI153 prebiotics product on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 18 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks.
* Constant drug use
* Students who are currently taking courses taught by the principal investigator of this trial.
* Subject who is not willing to have their photos published in public.
Cough Reflex Sensitivity and Bronchial Hyper-responsiveness

The aim of this study is to provide pilot data on the possible gastrointestinal predictors of respiratory hyper-responsiveness and how these relate to the clinical sub-types of gastroesophageal reflux disease (GERD) and visceral acid hypersensitivity.

This study recruited participants into three groups: reflux patients with non-erosive disease (NERD) with abnormal levels of acid reflux, NERD patients with normal levels of reflux and healthy volunteers. Participants were assessed for cough reflex sensitivity (CRS) to citric acid and bronchial-hyperresponsiveness (BHR) to methacholine challenge, both before (baseline) and after esophageal acid infusion (HCl, 0.15M) or normal saline control (8ml/min). The order of CRS and BHR was randomized, as was the order of the acid/saline infusions.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic reflux (i.e., one symptom at least one day a week, with at least 'moderate' severity)
* no evidence of esophagitis
* non-smokers

Exclusion Criteria:

* previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy
* active peptic ulcer disease
* Zollinger Ellison Syndrome
* Barrett's esophagus
* eosinophilic esophagitis
* cardiac disease
* diabetes or neurological deficit
* use of tricyclics
* selective serotonin reuptake inhibitors
* narcotics or benzodiazepines
* current use of medications that may affect symptoms of perception,lower esophageal sphincter basal pressure, acid clearance time or acid suppression
* antibiotics within 60 days
* Nursing mothers will be excluded
* allergies to citrus
* asthma
* chronic lung disease
* heart attack or stroke within the last three months
* hypersensitivity to methacholine products
* know aortic aneurysm
* uncontrolled hypertension (defined as systolic pressure greater than 200 or diastolic greater than 100)
* reduced pulmonary function test (forced expiratory volume in one second (FEV1) or the FEV1 to forced vital capacity (FVC) ratio (FEV1/FVC) of less that 70% of predicted value)
* None of the controls will have any GERD symptoms or ever used antireflux treatment.
Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma

This Phase II feasibility study, prospective, interventional, monocentric aiming to assess the interest of pre-operative rehabilitation in patients treated for bone or soft-tissue sarcoma of the limbs.

This protocol will be based on the realisation of a surgical prehabilitation program adapted to the patient. This strategy will involve a team of several health professionals: rehabilitation doctor, physiotherapist, occupational therapist, specialised nurse, dietician and adapted physical activity teacher.

The aim of an adapted surgical prehabilitation program is to improve the functional recovery of the treated limb and the patient's autonomy after surgery.

Each patient will be followed until 24 months post surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> or = 16 years old.
2. Patient with a diagnosis of bone or soft-tissue sarcoma confirmed by the "Réseau de Relecture en Pathologie Sarcomateuse (RRePS)"
3. Tumour localized in the lower or upper limb.
4. Localized or metastatic disease (in case of metastatic disease, the optimal surgical treatment for the primary tumor must be performed).
5. Indication of neoadjuvant treatment (radiotherapy and/or chemotherapy) according to the Multidisciplinary Concertation Meeting.
6. Inclusion before the initiation or during neoadjuvant treatment. In both cases, surgery must be scheduled between 6 and 10 weeks after inclusion, to permit the completion of the surgical prehabilitation.
7. Patient must provide written informed consent prior to any study-specific procedure. For minor patients, the holder(s) of parental authority must sign the informed consent and the patient's assent must be obtained.
8. Patient affiliated to the French social security system.

Exclusion Criteria:

1. Metastatic disease without optimal surgery planned of the primary tumour.
2. Any disease or medical condition that could interfere with study procedure, or that could, according to the judgment of investigator, expose the patient to an unacceptable risk.
3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
4. Any psychological, familial, geographic or social situation preventing compliance with the medical monitoring and/or with study procedure.
5. Pregnant or breastfeeding patient.
Language Treatment for Progressive Aphasia

Progressive aphasia is characterized by a steady and progressive loss of language skills in the presence of relatively preserved memory, attention, and thinking. The aim of this study is to slow the progression of language decline in progressive aphasia via language therapy. The first goal of this study is to improve naming abilities of individuals with progressive aphasia. This will be accomplished by carrying out an intensive treatment program for anomia. The second goal is to evaluate whether this intense language treatment re-activates affected areas and/or connections within the language network, using functional Magnetic Resonance Imaging (to measure neural activity in specific brain regions) and Diffusion Tensor Imaging tractography (to measure the connectivity between specific brain regions). This is the first study on progressive aphasia addressing both treatment and imaging in the same patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of progressive aphasia
* Native English speaker or fluent in English
* Adequate hearing and vision (not requiring more than +6 diopter correction)
* Willing and able to participate in each phase of the study (including two fMRI sessions)

Exclusion Criteria:

* Contraindications to fMRI (e.g., claustrophobia, pacemaker, ferromagnetic implant)
* Current medical or psychiatric condition affecting cognition (other than progressive aphasia)
Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

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 gemcitabine in treating patients who have persistent or recurrent cancer of the cervix.

OBJECTIVES:

* Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 15-37 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable

  * Eligible subtypes:

    * Adenocarcinoma
    * Adenosquamous carcinoma
    * Undifferentiated carcinoma
  * Must have documented disease progression
  * Histologic confirmation of original primary tumor required
* Bidimensionally measurable disease
* Ineligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* GOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* 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 and alkaline phosphatase no greater than 3 times normal

Renal:

* Creatinine no greater than 1.5 mg/dL

Other:

* No significant infection
* Not pregnant
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent filgrastim (G-CSF)

Chemotherapy:

* No prior gemcitabine
* At least 3 weeks since other prior chemotherapy for cervical cancer and recovered
* No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy)

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 3 weeks since prior radiotherapy for cervical cancer and recovered

Surgery:

* At least 3 weeks since prior surgery for cervical cancer and recovered

Other:

* No prior cancer treatment that would preclude study
F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer

RATIONALE: F511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women receiving doxorubicin hydrochloride liposome for metastatic breast cancer.

PURPOSE: This randomized phase III trial is studying F511 cream to see how well it works compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients receiving doxorubicin hydrochloride liposome for metastatic breast cancer.

OBJECTIVES:

* Evaluate the effects of F511 cream on the occurrence of palmar-plantar erythrodysesthesia (PPE) in patients with metastatic breast cancer treated with pegylated liposomal doxorubicin hydrochloride.

OUTLINE: This is a multicenter study.

Patients receive pegylated liposomal doxorubicin hydrochloride according to local practice on 1, 2, or 4 weeks course schedules with at least 10 mg/m\^2 per week allowed.

Patients apply F511 cream on one side, hand and foot and the corresponding placebo on the other side hand and foot once daily (the morning) during the first week of the first pegylated liposomal doxorubicin hydrochloride treatment only, then once daily, three times per week thereafter. Treatment continues throughout chemotherapy administration in the absence of palmar-plantar erythrodysesthesia (PPE) ≥ grade 2

After completion of study therapy, patients are followed for 30 days. Patients with PPE ≥ grade 2 are followed until the PPE resolves to ≤ grade 1.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of metastatic breast cancer

  * No cutaneous metastases on hands or feet
* Pegylated liposomal doxorubicin hydrochloride monotherapy is indicated according to the local investigator

  * Planned dose at least 10 mg/m\^2 per week
* No sign of palmar-plantar erythrodysesthesia (PPE) at study entry

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Able to apply topical medication (cream) or provide for another person to apply cream
* Not pregnant or breastfeeding
* Fertile patients must use effective contraception during trial participation and for 1 month after completion
* Negative pregnancy test
* Compliant and geographically proximal in order to allow proper evaluation and follow-up
* No dermatologic conditions (e.g., psoriasis) that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
* No known allergy or hypersensitivity to F511 cream

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 30 days since prior and no concurrent treatment with other experimental drugs or anticancer therapy
* More than 30 days since prior and no concurrent treatment on another clinical trial
* No concurrent local use of other ointments or creams for hands or feet other than Excipial Repair®
Efficacy of Dun Ye Guan Xin Ning Tablet in Patients With Stable Angina Pectoris

This registry is designed to investigate factors affecting the efficacy of Dun Ye Guan Xin Ning tablet on patients with stable angina. The potential hypothesis is that Dun Ye Guan Xin Ning has a better effect on different subgroup patients with certain characteristics.

A total of 1000 eligible patients enrolled from 20 centers will take standard medications of care for stable angina plus Dun Ye Guan Xin Ning tablet for 6 months. Symptoms, questionnaires (SAQ, PSQI, and angina pectoris quantitative table of Chinese medicine symptoms scale), lipid, fasting glucose, homocysteine, EKG, blood pressure and other physical examination will be collected at baseline and follow-up. Among them, 200 patients will measure and inflammation biomarkers and endothelial function for further evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 75 years.
2. Documented stable angina pectoris.
3. During a period of time (more than 3 months), the duration, severity and the threshold of angina is relatively stable.
4. Patients with at least one of the following events: ① patients who have done PCI or CABG for more than half a year; ② coronary CTA angiography or coronary angiography showed at least one major coronary artery stenosis ≥ 50%. Symptom occurs at least once per month.
5. Medications remain stable within 1 month before the enrollment.
6. Patients have the ability to understand the study, and can cooperate with researchers to carry out the test.
7. Signed inform consent.

Exclusion Criteria:

1. Patents with coronary heart disease acute coronary syndrome during the last 6 months.
2. Patients with aortic stenosis, hypertrophic cardiomyopathy and other diseases leading to angina.
3. Patients have other heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, biliary heart disease, gastroesophageal reflux caused by chest pain.
4. Patients combined with severe cardiopulmonary insufficiency (NYHA grade III ord IV), pulmonary insufficiency graded reference COPD clinical severity of lung function grade III (FEV1 / FVC \<70%, 30% 1 / FVC% of predicted value \<50%) and grade IV), severe arrhythmia (eg. III degree atrioventricular block)
5. Patients combined with liver, kidney, hematopoietic system and other serious primary disease patients (TBil ≥ 1.5ULN, AST ≥ 2ULN, ALT ≥ 2ULN, serum creatinine ≥ 1.5ULN, Hb \<9mg/dL).
6. Patients with cognitive, intellectual, or mental disorders.
7. Those who can not take oral medication.
8. Allergy to any component of this product.
9. Patients received the trial medication within 28 days prior to the first treatment of this product.
10. Lactating or pregnant women.
11. Patients who are unwilling or unable to contraceptive in the reproductive period.
12. Poor medication compliance.
13. Other circumstances that the investigator considers unsuitable for inclusion.
High-Intensity Interval Training for Older Adults

This study will examine differences in a 12 week high-intensity interval training regimen. The Total Body HIIT program incorporates a resistance (circuit) and an anaerobic (bike) component in older adults. The specific objectives focus on examining cardiovascular endurance, neuromuscular function, and muscle architecture.


Eligibility Criteria:
Inclusion Criteria:

* 65-95 years of age or older
* Physical independent (Barthel Index)
* Physician clearance to participate
* No medication changes in previous 30 days
* No structured resistance training program in previous 6 months

Exclusion Criteria:

* Contraindications to high-intensity exercise39 (PAR-Q Questionnaire)
* Severe mental impairment (\<18 on Montreal Cognitive Assessment)
* Neurodegenerative or acute neurological diagnoses (e.g., Parkinson's disease, stroke, traumatic brain injury)
Inhaled NO in Prevention of Chronic Lung Disease

To test the hypothesis that low-dose inhaled nitric oxide administered to preterm infants who continue to require mechanical ventilation at 14 days of age will reduce the incidence of chronic lung disease.

BACKGROUND:

Respiratory morbidity, particularly chronic lung disease (CLD), remains a major cause of long-term morbidity and mortality for preterm infants. Although surfactant replacement has decreased acute respiratory morbidity and mortality, it has not reduced the incidence of CLD. A number of other approaches, including antenatal thyrotropin releasing hormone in conjunction with corticosteroids, postnatal steroid administration, as well as administration of Vitamin E, diuretics, and bronchodilators, have not resulted in clinically important decreases in CLD. Infants with the most severe CLD go on to develop findings suggestive of pulmonary hypertension with cor pulmonale. There is preliminary evidence in the preterm infant with severe chronic lung disease that low-dose inhaled nitric oxide may significantly attenuate the disease and decrease mortality.

DESIGN NARRATIVE:

The multi-center, controlled and blinded trial investigates the hypothesis that low-dose inhaled nitric oxide administered to preterm infants between 500 and 1250 grams birth weight who continue to require mechanical ventilation at 10 days of age will increase survival without chronic lung disease (CLD) at 36 weeks post menstrual age. Secondary outcomes are duration of ventilation, oxygen requirement and duration of hospitalization. In addition, that there will be expected improvement in infant respiratory status (ventilatory support, airway resistance and compliance) associated with inhaled nitric oxide treatment. Indicators of inflammation and oxidant stress will be assessed by measurements of specific cytokines and protein modifications in tracheal aspirate and plasma samples, respectively. The safety of this therapy will be evaluated by assessing toxicity as measured by clinical bleeding, including intraventricular hemorrhage as well as the incidence of other morbidities of the preterm infant (necrotizing enterocolitis, retinopathy of prematurity and infection) and assessing neurodevelopmental outcome through two years of age. A total of 480 infants were randomized to either inhaled NO or placebo. In summary, this clinical trial will assess the efficacy and safety of inhaled nitric oxide for amelioration of a major disease of premature infants.

Eligibility Criteria:
Preterm infants who are 500-1250 grams at birth and who require mechanical ventilation at 10 to 21 days of age. Exclusions include congenital heart disease or pulmonary abnormalities, including a patent ductus arteriosus, ventilation solely for apnea, small-for-gestational age, or clinical bleeding.