cyrilzakka/clinical-trials huggingface dataset:
Benefits of Using a Transparent Visor to Replace the Face Mask in Speech Therapy Rehabilitation of Oral-Linguo-Facial Praxies in the Context of COVID-19: a Series of Cases

The primary objective of the study is to compare the effectiveness of the use of a transparent covering visor with that of the face mask, with or without the use of video sequences, for speech therapy rehabilitation of oral-linguo-facial praxies in the context of the COVID 19 epidemic.

Statistic analysis: single case experimental design (SCED) method.

Eligibility Criteria:
Inclusion Criteria:

* Aged \>= 18 years;
* Hospitalization for more than 2 weeks prior to enrollment in the adult post intensive care rehabilitation care unit (PICRU) of Raymond Poincaré hospital in Garches;
* With oral-linguo-facial praxis disorders whatever the cause;
* Has been informed and not in opposition to participation of the study.

Exclusion Criteria:

* Patient with fever or any suspect symptom of a SARS-CoV2 infection;
* Planned discharge of hospital in 2 weeks;
* Patient with cognitive, phasic or vigilance disorders preventing to understand the study;
* Under guardianship or curator;
* Patient Under french AME scheme.
A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)

To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.

Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males between the ages of 18-55 with LDL More than 130, but less than 180

Exclusion Criteria:

* Individuals with drug or substance abuse
* Individuals with poor mental function
* Individuals having more than 14 alcoholic drinks a week
* Individuals that have been treated with any other investigational drug in the last 30 days
The Effect of Polycystic Ovary Syndrome Treatment on Metabolomics

The aim of this study is to determine the effect of the treatment of polycystic ovary syndrome with two different oral contraceptives that contain cyproterone acetate and drospirenone

Polycystic ovary syndrome (PCOS), is the most common endocrinological disorder that affects the reproductive aged women. In addition to causing problems such as menstrual irregularity, hirsutism, acne, it is also an important health problem that can cause infertility, insulin resistance, impaired glucose metabolism, diabetes, high blood pressure, heart disease, dyslipidemia in advanced ages. Diagnostic criteria also vary widely in these patients. These patients are often overweight or obese, and abdominal adiposity is common in these patients. The patients also suffer from insulin resistance and hyperinsulinemia in this syndrome. All of this is probably the result of a vicious cycle that starts in the antenatal period. Combined oral contraceptives (COCs), are the first-choice treatment option for many patients by improving both menstrual irregularity, hyperandrogenism, and insulin resistance through sex hormone binding globulin (SHBG). They reduce the risk of endometrial hyperplasia and endometrial cancer by providing regular menstruation.

Nowadays, the use of metabolomics is increasing in understanding the pathophysiology of diseases. Metabolomics technology examines low molecular weight substrates used in intracellular enzymatic reactions, intermediates and end products resulting from these reactions. Metabolomic examinations are gaining momentum in terms of understanding the pathophysiology of diseases, especially endometrial cancer and ovarian cancer, in the field of Obstetrics and Gynecology. Metabolomics continue to be investigated in understanding the pathophysiology of PCOS, but there are not enough studies yet on the effects of treatment on the disease in terms of metabolomics.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with polycystic ovary syndrome according to Rotterdam criteria and who do not have any additional chronic systemic disease

Exclusion Criteria:

* The presence of any diseases that cause hormonal disorders and any chronic systemic diseases, the patients who are already under any treatment for polycystic ovary syndrome
Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

The purpose of this research study is to see if people whose Acute myeloid leukemia (AML) is being successfully treated with azacitidine or decitabine in combination with venetoclax can discontinue this chemotherapy for some period of time after a year of treatment without increasing the likelihood that their AML will return.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older at the time of obtaining informed consent.
* Diagnosed with Acute Myeloid Leukemia (AML) (non-M3) as defined by 2016 World Health Organization (WHO)
* Eastern Cooperative Group (ECOG) performance status score ≤ 2
* Currently on frontline therapy with HMA (azacitidine or decitabine)/VEN and achieved Complete Remission (CR)/Complete Remission with incomplete marrow recovery (CRi) with MRD negativity defined as \< 0.1% by Multiparameter Flow Cytometry (MFC)
* Within 12 months of starting HMA (azacitidine or decitabine)/VEN
* Ineligible for or declined allogeneic hematopoietic cell transplantation (HCT)
* Ability to understand and the willingness to sign a written informed consent document
* Must agree to adhere to the study visit schedule and other protocol requirements
* Patients must be able to provide adequate Bone Marrow (BM) aspirate and biopsy specimens for histopathological and Measurable Residual Disease analysis during the screening procedure

Exclusion Criteria:

* Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of AML within 28 days, or 5 half-lives, at the start of the study. Only patients who are receiving frontline HMA (azacitidine or decitabine)/VEN are potentially eligible, but if they had received a course of hydroxyurea prior to achieving CR/CRi, this is allowed.
* Any serious medical condition or uncontrolled current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or will place the subject at unacceptable risk if he/she participates in the study. Controlled infections or other medical conditions on long-term therapy is allowed.
* Patients who harbored TP53 mutation at diagnosis
* AML with extramedullary involvement including central nervous system (CNS) involvement, myeloid sarcoma, and leukemia cutis requiring directed therapy at the time of enrollment.
* Patient is pregnant.
Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain

This study is to see whether the low-dose coronary computed tomographic angiography (CCTA) protocol is as safe and efficacious as conventional-dose protocol in early triage of acute chest pain.

Currently, CCTA is a valuable tool for early triage of low to intermediate risk acute chest pain patients in emergency department. However, it has been criticized for causing unnecessary radiation exposure in the population where its majority has no coronary lesion. A low-dose CCTA protocol comprised with 1) dedicated cardiac imaging protocol (rather than triple rule-out protocol), 2) prospective gating and 3) without additional imaging for calcium scoring will be used to implement the low-dose imaging. We hypothesized that the low-dose CCTA protocol will be as safe and efficacious as conventional dose protocol while decreasing the amount of radiation exposure significantly.

Eligibility Criteria:
Inclusion Criteria:

- Patients visiting emergency department for A) acute onset (\<12hr) chest pain or equivalent symptoms B) aged between 25-55, C) that requires to rule out acute coronary syndrome.

Exclusion Criteria:

1. Known coronary artery disease and/or any related intervention (STENT, CABG)
2. Elevated cardiac biomarkers (CK-MB, Troponin I)
3. Ischemic ECG changes
4. Documented evidence of low LV systolic function (ejection fraction ≤ 45%)
5. TIMI risk \>4
6. Unstable vital sign (e.g. hypoxemia, shock)
7. Patients with contraindication to iodinated contrast and/or beta blockers including renal failure or reactive airway diseases such as COPD or asthma
8. Atrial fibrillation on initial ECGs
9. Active renal disease, serum creatinine ≥1.5 mg/dl
10. Negative coronary angiography or CCTA within 6 months
11. Modified Wells criteria \>4 or D-dimer \> 0.5ug/mL
12. Suspicious of aortic dissection or D-dimer \> 0.5ug/mL
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors

This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally twice per week, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.


Eligibility Criteria:
Inclusion criteria

* Patients with histological or cytological confirmed advanced solid tumors, which progressed despite standard therapy or for whom no standard therapy exists
* Life expectancy of at least 3 months
* No dysfunction of bone marrow
* No major impairment of renal and hepatic function

Exclusion criteria

* Gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that could alter absorption of the study drug
* Receipt of any investigational compound within the 28 days prior to the first dose of study drug, or failure to recover from the side effects of such prior therapy
* Receipt of other antineoplastic therapy including chemotherapy, hormone therapy, immunotherapy, radiation therapy within the 28 days
* Patients known to be HIV, or hepatitis B or C viruses positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection
* Patients with a history of allergies to the camptothecin family of drugs

Other protocol-defined inclusion/exclusion criteria may apply
Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)

This trial will evaluate the efficacy in colon cleansing of a nurse-led educational telephone intervention 24-48 hours before a colonoscopy, in selected participants with a previous inadequate bowel preparation.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with a colonoscopy with inadequate bowel preparation, for any indication and where the endoscopist considers that the colonoscopy should be repeated to optimize the visualization with a better bowel preparation. Participants must have been properly informed and they have to sign the inform consent.

Exclusion Criteria:

* Hospitalized patients
* Unwillingness to participate in the study
* Inability to follow instructions: cognitive impairment or language barrier
* Inability to use a telephone or not owning a telephone
* Active inflammatory bowel disease
* Severe renal impairment
* Pregnancy of breast feeding
Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly

Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly


Eligibility Criteria:
Inclusion Criteria

Body Mass Index (BMI) 19 to 33, inclusive

Either normal kidney function, or mild or moderate kidney impairment

Exclusion Criteria

Use of any medications, vitamins and/or herbal supplements within 2 weeks prior to study drug administration, except those required for management of renal disease.

History of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Nurses' Adherence to Professional Nursing Code of Ethics and Quality of Nursing Care Satisfaction

Nursing code of ethics is an essential part of nursing professional practice. Nurses' adherence to a code of ethics is an important pillar of improving their performance, providing good nursing care and achieving patient satisfaction.

Nursing code of ethics is an essential part of nursing professional practice. Nurses' adherence to a code of ethics is an important pillar of improving their performance, providing good nursing care and achieving patient satisfaction.This study aimed to examine relationship between nurses' adherence to an Egyptian professional nursing code of ethical practice and patient satisfaction with quality of nursing care in critical and medical-surgical care units.

Eligibility Criteria:
Inclusion Criteria:

* Nurses

  * willing to participate in the study
  * work in surgical intensive and critical care units
  * Sign a consent
* Patients

  * Alert, conscious and educated patients
  * More than 18 years old

Exclusion Criteria:

* Nurses

  * Work in outpatient units and other units
  * Did not sign a consent
* Patients

  * Unaware or could not communicate
  * less than 18 years old
Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2

To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine


Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of malignancy that is now advanced, non resectable and/or metastatic
* Tumours historically known to overexpress EGFR and/or HER2

Exclusion criteria:

* Prior treatment with HER2 inhibiting drugs within the past 4 weeks before the start of therapy or concomitantly with this trial.
* Prior treatment with EGFR inhibiting drugs within the past two weeks before the start of therapy or concomitantly with this trial.
Comparison of 2 Pupillometric Indices in Cerebral Brain Patients

Pupillary examination, and in particular pupillary reactivity to light, is fundamental to the monitoring and follow-up in intensive care units of patients with acute brain injury. A pupillometric index combining different parameters of pupillary light reflex has been described as predictive of intracranial hypertension and the neurological outcome of the patient.

Pupillary examination, and in particular pupillary reactivity to light, is fundamental for the monitoring and follow-up in intensive care units of patients with acute brain injury. Intracranial pressure monitoring and pupillometry measurement are thus part of the routine practice of intensive care unit management of brain injured patients. Furthermore, elevated intracranial pressure in brain injured patients admitted to the ICU is associated with a poor prognosis, and very high intracranial pressure is a life-threatening situation.

A pupillometry index combining different parameters of pupillary light reflex has been described as having predictive value of intracranial hypertension and neurological outcome of the patient: the "NPi". Another manufacturer IdMed, Marseille, France proposes an index: the QPI (Quantitative Pupillometry Index), based on a statistical classification of the amplitude of the light reflex.

The aim of this study is to show that :

* QPI is equivalent to NPI
* An abnormal value of the pupillometry indexes (NPI/QPI) is predictive of high intracranial pressure.
* An abnormal value of pupillometry indexes (NPI/QPI) is predictive of a poor neurological outcome at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Patients admitted for any brain injury: traumatic, intracranial hemorrhage, subarachnoid hemorrhage
* Pupillometry available as a standard assessment tool.
* Patient intubated/ventilated for neurological reasons for more than 12 hours

Exclusion Criteria:

* Non-intensive care patients
* Facial and or ocular trauma not allowing pupillometry evaluation
* Patients admitted to the ICU with a life expectancy of \< 24 hours
* Protected persons (under guardianship, curators, pregnant or breastfeeding women, persons deprived of liberty, persons not subject to a psychiatric measure)
* Patients not affiliated to a social security system
* Patients who object to the use of their data for research purposes
Treatment of Moderate to Severe Glabellar Lines

The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe GL.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 years of age or older.
2. Moderate to severe GL at maximum frown as assessed by the Investigator.
3. Moderate to severe GL at maximum frown as assessed by the subject.

Exclusion Criteria:

1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
2. Female who is pregnant, breast feeding, or intends to conceive a child during the study.
3. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.
The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults

The aim of the study is to assess the effect of Methylphenidate on cognitive performance and decision-making ability of ADHD adults, and to compare this effect to the effect on healthy control adults.

Two matched groups of adults - with and without ADHD diagnosis - will perform a battery of computerized tasks assessing sustained attention,working-memory,non-verbal IQ,and decision-making ability. In each group,half of the participants will perform the tasks after receiving a capsule containing methylphenidate (MPH), and the other half will perform the tasks after receiving placebo. Task performance measures will then be compared in order to assess the effect of MPH on these domains.

Eligibility Criteria:
Inclusion Criteria:

* adults in the age of 21-50

Exclusion Criteria:

* pregnant or nursing women.
* people who suffer from a psychiatric disorder other than ADHD which could account for their inattention symptoms better than ADHD.
* people who lack judgment or are unable to communicate with the experimenters.
* people who are incapable of performing the computerized tasks due to sensory or motor disabilities.
Chemoresistance of Trophoblastic Tumors

Gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. These are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. The therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a clinico-biological score, FIGO score, which includes tumor size, gonadotropic chorionic hormone level used as quantitative tumor marker, number and localization. metastases. A FIGO score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of approximately 99.7%. Scores of 7 to 12 and ≥13 require multidrug therapy (EMA-CO) and are associated with 5-year survival of 95.1% and 61.6%, respectively.

The chemotherapies currently used for the treatment of trophoblastic tumors have been described between the 1950s (methotrexate) and the 1980s (EMA-CO) and have a well documented toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. .

To date, apart from the FIGO score, there is no predictor of resistance to chemotherapy in gestational trophoblastic tumors. However, among patients with a FIGO score ≤6 and receiving methotrexate in the first line, 9 to 46% will have a resistance and require a second line of treatment. Similarly, if the score is ≥7, 10 to 30% of patients receiving EMA-CO will require at least a second line of multidrug therapy.

The hypothesis of PrediCTTro study is that tissue samples of gestational choriocarcinoma present a transcriptomic profile associated with the risk of further resistance to single or multiagent chemotherapy.

The objective of PrediCTTro is to identify a transcriptomic signature able to predict resistance to single or multiagent chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* confirmed gestational trophoblastic tumor histology
* hCG follow-up of at least 12 months after hCG normalization
* registration in the French Reference Center for Trophoblastic Diseases

Exclusion Criteria:

* tissue specimen (block/biopsy) not available
* degraded quality of tissue sample not compatible with transcriptome analysis (\>20% of necrosis)
Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.
2. ACR functional class I-III
3. Have active RA
4. Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha

Exclusion Criteria:

1. Patient had a major surgery within 2 weeks prior to study entry.
2. Life expectancy \< 6 months.
Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine

The purpose is to study the relation between pupillary diameter measured under scotopic conditions, and the pain thresholds measured at the time of peak and residual effect of methadone/buprenorphine in opiate-dependent patients following a substitution program.

Patients substituted since at least 3 months shall be included during a regular control visit.

Each session shall consist in

* check for toxics in urine sample;
* measurement of pupil diameter;
* measurement of mechanical punctuate pain threshold;
* measurement of mechanical bone pain threshold.

A first session shall be done at time of residual effect of the opiate. A second session shall be done at time of peak effect of the opiate.

Eligibility Criteria:
Inclusion Criteria:

* substitution treatment stable since at least 3 months
* capacity to understand the protocol
* likely to come to visits
* covered by French welfare

Exclusion Criteria:

* chronic pain
* concomitant acute pain
* pregnancy or breast feeding
* relevant mental disease
* peripheral neuropathy
* diabetes
* regular intake of ketamine
* neuroleptic concomitant treatment