cyrilzakka/clinical-trials huggingface dataset:
Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma

The study is to evaluate the efficacy and safety of Apatinib as maintenace therapy for Nasopharyngeal Carcinoma With Metastasis after Chemoradiotherapy, including progress free survival(PFS)、overall survival (OS)、Quality of life score (QoL) and evaluation of drug safety.

In locally advanced nasopharyngeal carcinoma(NPC), although radiotherapy and chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for metastatic NPC who failed to chemoradiotherapy therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib as maintenance therapy after chemoradiotherapy in nasopharyngeal carcinoma with metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged ranging from 18 to 75 years old.
* Naive or recurrent Nasopharyngeal Carcinoma with metastasis after chemotherapy or radiotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
* Adequate hematologic (neutrophil count\>=1.5×109/L, hemoglobin\>=80g/L, platelets\>=80×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT) =\<upper normal limit(UNL) x2, bilirubin level =\< UNL x 1.5).
* Adequate renal function (creatinine clearance ≥ 60 mL/min).
* Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.

Exclusion Criteria:

* Previously, patients did receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib.
* Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
* Bleeding tendency or coagulation disorders.
* with brain metastases.
* Uncontrolled hypertension (systolic pressure\>150 mmHg , or diastolic pressure\> 90 mmHg).
* Urine protein≥++, or urine protein in 24 hours≥1.0g
* Severe uncured wounds, ulcers or fracture.
* Pregnant or breast-feeding.
* Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
* Patients have these symptoms, such as neurological diseases, mental illness, serious infection.
* The researcher believe that the Patient is not suitable to participate in the study.
Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa

The BodyBabe studies aims to evaluate the perceptions that young mothers with anorexia nervosa (active or in remission) have of their own body and of the body of their child. The evaluations are carried out with self-assessment questionnaires and silhouette scales at three time points: D0 (during the stay at the maternity hospital), D15 (15 days after delivery) and M9 (9 months after delivery).

The output expected from this study is to validate a questionnaire to help healthcare providers to adapt their care of women with anorexia nervosa during the pregnancy and the post-partum period.

During the stay at maternity hospital, healthcare providers will identify potential candidates for the study on a daily basis according to the following criteria :

* BMI at the beginning of the pregnancy lower than 18,5 kg/m2 And/or
* History of anorexia nervosa

Tools and methods

The questionnaires used for the self-assessments are the following :

* Two questionnaires that evaluate the body satisfaction

  * The Body Shape Questionnaire (BSQ)
  * A questionnaire assessing the satisfaction of the mother regarding her baby's body shape (BodyBabe questionnaire).
* Two silhouette scales

  * Stunkard scale also called Figure Rating Scale (FRS)5
  * Infant Body Figure Drawings
* A questionnaire evaluating the severity of the eating disorders : Eating Attitude Test (EAT)
* A questionnaire detecting depression symptoms during post-partum : Edinburgh Post-natal Depression Scale (EPDS)

Eligibility Criteria:
Inclusion Criteria:

* adult woman, understanding and reading French, delivering in the CHU (Centre Hospitalier Universitaire) Clermont-Ferrand maternity hospital between 01/15/2020 and 01/14/2021, and with active or in remission anorexia nervosa diagnosed according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders)
* able to accept participating to the study
* Affiliated to the national healthcare system

Exclusion Criteria:

* delivery before 32 weeks of amenorrhea (significant prematurity and extreme prematurity)
* death in utero or medically-motivated induced termination
* infant death during labour or post-partum
* refusal to participate
Benefits of the Involvement of Nurses in Meetings Between Physicians and the Families of Patients in the ICU.

When a patient is admitted to the ICU this often happens so suddenly that this can create a significant amount of stress and anxiety for family members for several reasons. Firstly, the family does not have a pre existing relationship with the ICU team. Secondly, the urgency of the situation and the technic it requires is often such that minimal information can be given to family members. And finally, as a result of the unpredictability of each patient's condition, it can be difficult to predict outcome for family members. Together, these factors compound the stress and anxiety of family members. This anxiety is natural and it is important for health caregivers to be able to offer the best support possible. A high quality communication provided by structured information given by physicians and nurses as well could improve support to the families and lead to greater satisfaction.

Giving information to families during meetings is crucial at 3 moments: at the first day when the patient is admitted, at day 3, weekly and each time important news is given (surgery, deterioration in condition, end-of-life).

The purpose of this project is to evaluate if the involvement of nurses during those meetings could improve quality in communication which is assessed by mixed methods. Families and healthcare workers satisfaction will be assessed by qualitative methodology. Family peritraumatic stress, symptoms of anxiety and depression and PTSD will be assessed using validated scales.

Training of healthcare workers will be done by role play. Information to the families is delivered using a framework for physicians and nurses. All the meetings of the study will be audited by a psychologist.

-Randomized trial with two arms: arm 1: information is delivered by a team (physician and nurse) arm 2: information is delivered by the physician alone

-During the different meetings of the study: at day 1, at day 3, weekly and in case of deterioration of the patient condition.

The other days, family information is delivered as usually in both arms.

Eligibility Criteria:
Inclusion Criteria:

1. patient : adult, 1 relative at minimum, mechanically ventilated at least 48 hours; and
2. family : french-speaking, adult;

Exclusion Criteria:

* Conflict, organ donor, refusal to participate.
Barriers to the Implementation of Complete Insulin Order Sets

The major purpose of this Quality Improvement project is to begin to address the issues surrounding glycemic control in the hospital setting by collecting accurate, reliable and verifiable data on the occurrence of hyperglycemia (BG \>300 mg/dL), and whether or not CIO is used (immediately before and 72 hours after the BG \>300 mg/dl).


Eligibility Criteria:
Inclusion Criteria:

* Park Nicollet Methodist Hospital patient
* recorded BG \> 300 mg/dL during the study data collection period
* admitted to general floor hospital units

Exclusion Criteria:

* birth center
* intensive care units
* eating disorder unit
* pediatric patients \< 18 years of age
* patients receiving insulin infusions
Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)

The purpose of this study is to investigate if interferon-alpha2a is superior to the standard treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcet's disease.

Behcet's disease is a multisystem vasculitis often involving ocular (retinal) blood vessels (in 70% of all cases). This form of uveitis or retinal vasculitis still leads to blindness in 25 to 50% of the patients irrespective of immunosuppressive treatment.

The aim of the study is to evaluate if Interferon-alpha2a is superior to the present standard treatment (cyclosporin A (CSA)) for severe ocular (panuveitis, posterior uveitis, retinal vasculitis) Behçet's Disease (BD) and significantly improves visual prognosis and quality of health and life of the patients with ocular BD and is acting more rapidly than standard treatment. Furthermore, we want to evaluate if IFN-α induces long term remissions of ocular BD which can be maintained without further medical treatment.

The patients are randomised into two treatment groups (IFN/CSA) and treated for one year according to an algorithm which adapts dosages to clinical course. A crossover from one treatment arm to the other is planned in case of inefficacy.

Eligibility Criteria:
Inclusion Criteria:

* Behçet's disease fulfilling the International Study Group Criteria with active pan- or posterior uveitis (according to the posterior uveitis scoring system) or retinal vasculitis and active disease according to the Behcet's Disease activity scoring system.

Exclusion Criteria:

* Previous treatment with interferon-α or cyclosporin A
* Pregnancy, breast feeding women, malignancy
* Renal impairment (creatinine \> 1.5 mg/dl)
* Uncontrolled hypertension or diabetes
* Depression or other psychic disorders(also history of depression)
* History of acute or chronic inflammatory joint or autoimmune disease
* Organ or bone marrow transplant recipient, cardiac failure \> NYHAIII
* Acute liver disease with SGPT 2x above normal
* White blood cell count \< 3500/mm3
* Platelet count \< 100000/mm3
* Hgb \< 8.5g/dl
* Body weight \<45 kg
* Alcohol abuse or drug abuse
* Mental impairment
* Uncooperative attitude
Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy

The purpose is to see how quickly two different types of prostate cancer participants respond when taking enzastaurin.

Cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen (PSA)-progressive disease without clinical or radiographic evidence of metastatic disease.

Cohort 2 - participants with androgen-independent metastatic prostate cancer (documented bone or soft tissue metastases) with rising PSA, clinical, radiographic disease progression following one prior docetaxel-based regimen


Eligibility Criteria:
Inclusion Criteria:

* You are expected to be alive in the 12 weeks.
* You are at least 18 years old.
* You live close enough to the doctor's office to attend all of your required visits.
* You have not been treated with chemotherapy for your prostate cancer (cohort 1).
* Must have evidence of androgen-independent PSA-progressive disease without a history of or current (as judged by the investigator) clinical or radiographic evidence of metastatic disease with castrate levels of testosterone (\<50 ng/dL) maintained by luteinizing hormone-releasing hormone (LHRH) agonist or bilateral orchiectomy following standard anti-androgen withdrawal. NOTE: PSA progression is defined as have rising PSA values of \<=5 ng/mL (at least 3 measurements 1 week apart) with castrate levels of testosterone \<50 ng/dL following appropriate antiandrogen withdrawal, without evidence of metastases. (cohort 1)
* No prior systemic chemotherapy for prostate cancer. No prior chemotherapy for any other indication within 2 years of study entry. NOTE: Participants previously treated with chemotherapy in the adjuvant/neoadjuvant setting were not be eligible. (cohort 1)
* You have had one prior docetaxel-based chemotherapy regimen (cohort 2).
* You have evidence of metastatic prostate cancer with bone or soft tissue disease (cohort 2).
* Must have evidence of docetaxel-resistant, androgen-independent metastatic prostate cancer with bone or soft tissue disease (PSA only participants are not eligible) defined as either: clinical, PSA or radiographic disease progression while receiving docetaxel-based therapy or PSA and/or radiographic progression at any time after completion of a docetaxel-containing regimen with PSA progression defined as a 25% increase in PSA from the post docetaxel value or interval progression in known metastatic sites of disease or development of new sites of disease on bone scan or computed tomography (CT) imaging. Note: Participants who discontinued a docetaxel-containing regimen due to toxicity or any other reasons not related to disease progression while on treatment, and were not able to complete at least 2 cycles, were not be eligible. (cohort 2)
* Your organs must be functioning properly.

Exclusion Criteria:

* You are unable to swallow pills.
* You have another illness besides your prostate cancer.
* You have taken another experimental drug within the last 30 days.
* You have a serious heart condition.
* You are receiving another anti-cancer therapy.
An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer

The primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer.

The primary objectives of this study are to identify the maximum tolerated dose(MTD) and to evaluate safety of atiprimod in patients with advanced cancer.

The secondary objectives of this study are 1) to measure the pharmacokinetics of atiprimod and 2) to evaluate the efficacy of atiprimod treatment in patients with advanced cancers and 3) to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.

Eligibility Criteria:
Inclusion Criteria:

* histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
* estimated life expectancy of at least 12 weeks.
* must have evaluable disease.
* ECOG(Zubrod) PS of 0 to 2
* sign informed consent.
* age 13 years or more at time of signing informed consent.

Exclusion Criteria:

* renal insufficiency
* concomitant radiotherapy, chemotherapy or other investigational therapies.
* peripheral neuropathy grade 3 or greater (NCI CTC version 3 grading)
* evidence of clinically significant mucosal or internal bleeding
* any condition that in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study.
* clinically relevant active infection or serious co-morbid medical conditions.
* as atiprimod is a potent inhibitor of CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics will be excluded.
Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging

Investigators hypothesize that chronic primary headaches are accompanied by a discrete pattern of brain metabolism and activity involving brain structures related to the development of acute exacerbations as well as pain modulation. Such structures include the brainstem, hypothalamus, and orbitofrontal cortex and can be defined using functional brain imaging.

Specific aims of the study include:

1. To determine the pattern of brain metabolism using positron emission tomography (PET) found in chronic migraine, episodic migraine and control patients.
2. To determine changes of resting state brain networks using magnetic resonance imaging (MRI) between patients with chronic or episodic headache and healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65

  * No medical contraindication.

Chronic headache group:

* Patients with chronic primary headaches who are experiencing phases with background pain as well as habitual pain exacerbations.
* Able to provide informed consent.
* Not pregnant or planning to become so, with a pregnancy test prior to scanning.

Control group and Episodic migraine group:

* Patients with episodic migraine
* Able to provide informed consent.
* Not pregnant or planning to become so, with a pregnancy test prior to scanning.

Exclusion Criteria:

* Taking a migraine preventive currently or in the last fifteen days.
* Known claustrophobia
* Patient is pregnant, planning to be pregnant, or becomes pregnant.
* Patients with metal implants.
* Patients who have had a study involving radiation within the one year prior to enrolling in this study
Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer

Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study.
* The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
* The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit
* The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening

Exclusion Criteria:

* The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm.
* The patient has a modified Hachinski ischemia score greater than 4 at the screening visit.
* The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD
* The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor

Other protocol defined inclusion and exclusion criteria may apply
EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty

The goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* Indicated for a surgical repair for moderate to severe mitral valve regurgitation at rest (level 2 or higher);
* Willing to return to the hospital where the implantation originally occurred as part of the standard practice of care

Exclusion Criteria:

* Heavily calcified valves
* Valvular retraction with severely reduced mobility
* Active bacterial endocarditis
* Already participating in another investigational device study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints;
* Life expectancy of less than one year;
* Pregnant or desire to be pregnant within 12 months of the study treatment;
* Under 18 years or over 85 years of age.
Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases

This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children with inflammatory and non-inflammatory conditions.

Children and young adults age 6-24 with the following conditions: asthma, pneumonia, allergic rhinitis, cystic fibrosis, and well child (without inflammatory illness) will be recruited.

Subjects will be asked to complete a brief screening survey to determine if they meet inclusion criteria. Enrolled subjects will be asked to complete questionnaire forms to characterize their health, current symptoms, medications, and common exposures. Transcutaneous carboxyhemoglobin will be recorded.

This study is cross-sectional and will only require one visit coinciding with the clinical visit. Analysis will determine the pairwise differences in SpCO between conditions tested.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of asthma, pneumonia, allergic rhinitis, or none of the previous (control group)
* Ability to complete study procedures

Exclusion Criteria:

* Cardiopulmonary disease outside of the specific conditions for inclusion
* Prematurity
* Congenital heart disease
* Current diagnosis of more than one of the following: asthma, pneumonia, allergic rhinitis, cystic fibrosis, or - for controls - any current infection
* Recent serious bacterial infection (except for pneumonia in the pneumonia group)
* Concurrent clinical chest X-ray with findings other those that expected for the group (i.e. normal chest X-ray in pneumonia group or suspected pneumonia on chest X-ray in asthma group). To be determined by attending radiologist's interpretation.
Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in Premature Population

Autonomic nervous system (ANS) is an essential regulator for the homeostasis, circulatory and respiratory systems. Heart rate variability, under the dependence of the parasympathetic and orthosympathetic arms is a peripheral witness of its well functioning.

Activity ANS indices are technically measurable from the birth by non invasive cardiac monitoring: in given environmental conditions. According to the individualized care given to the baby, we can easily observe by frequential analysis, modifications of ANS level activity; If for a full-term newborn, the balance of ANS allows him to adapt its cardiac frequency to its internal and external environment (thermoregulation, baroreflex, sinus arrhythmia, awakening state) , the premature birth is at the origin of a prolonged defect of global ANS maturation, probably induced by external environmental and stress factors (pain, stimulations, aggressive noise and lights). This disrupted maturation profile in case of prematurity, was confirmed in two preliminary studies on premature babies reaching term for gestational age.

We hypothesis that adapted sensorimotor care could decrease this stress and optimize the ANS activity profile.

In a prospective study, by a non invasive real-time measure, we analyse impact of stress on ANS activity in a premature population, hospitalized in our neonatal intensive care units.


Eligibility Criteria:
Inclusion Criteria:

* premature birth
* hospitalized in the intensive care unit or in the neonatology unit or in the reanimation unit of the Pediatric Hospital of SAINT-ETIENNE

Exclusion Criteria:

* arrhythmias
* general anaesthesia three weeks before the records