cyrilzakka/clinical-trials huggingface dataset:
STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03

The main objective of this national, open-label, non-randomized phase II trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins.


Eligibility Criteria:
Inclusion Criteria:

* Operated squamous cell carcinoma of oral cavity (lips excepted) or oropharynx
* pT1 or pT2 ((UICC 7th edition 2009)
* Indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria :

  * positive R1 margin (re-resection not proposed)
  * close margin \< 5 mm (re-resection not proposed)
  * Margin estimated at risk, with uncertain pathological margin (re-resection not proposed)
* N0 after surgical management of the neck (neck dissection or sentinel lymph node biopsy) or pN1 without extracapsular extension (carcinological neck dissection)
* Age ≥ 18 years
* ECOG status ≤ 2
* Written signed informed consent before any specific procedure of the protocol
* Affiliation to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Other histology than squamous cell carcinoma
* pT3 or pT4
* pT2\>3cm and R1 with concurrent chemoradiotherapy decided in multidisciplinary tumor board
* Lymphovascular invasion justifying neck irradiation
* Neck irradiation decided in multidisciplinary tumor board
* Lack of at least one of the following elements :

  * pre-operative medical imaging (CT scan or MRI)
  * endoscopy report
  * surgery report
  * pathological report
* Prior radiotherapy to the head and neck area
* Distant metastasis
* Pregnant or nursing (lactating) woman
* women or men of childbearing age not taking adequate contraceptive measure
* participation in another investigational study within 4 weeks prior to inclusion
* History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Persons deprived of their liberty, under guardianship or curatorship, or unable to follow the trial for geographical, social or psychological reasons
Barberry and Cardiometabolic Risk Factors in Individuals with Hypertriglyceridemia

Barberry is a well-documented medicinal plant that is utilized as a feed additive in a variety of food cultures. Barberry is a rich source of antioxidants, minerals, phenolic compounds, and flavonoids. Based on the results of animal and human studies, barberry may have therapeutic and medicinal properties, including the ability to improve blood lipid profile. The present study will investigate the effect of seedless barberry consumption on cardiometabolic factors in overweight or obese individuals with mild to moderate hypertriglyceridemia.

This study is an open-label, randomized, controlled clinical trial and will recruit those who are willing to participate and meet the inclusion criteria. Inclusion criteria are fasting serum triglycerides 150-499 mg/dL, body mass index 25-40 kg/m2, age range 18-75 years. Exclusion criteria are regular use of drugs of the fibrate family, regular use of fish oil supplements or omega-3 supplements or flax seed or chia seed, treatment with glucocorticoids, end-stage renal disease. Subjects who agree to participate in the study will be randomly assigned to one of two study groups. All patients in both groups will be prescribed a low-calorie diet. In the first group, 10 grams of powdered seedless barberry will be consumed daily in addition to the low-calorie diet. The second group (control group) will continue with the low calorie diet. The study will last 8 weeks. Patients are asked to refrain from using over-the-counter herbal medicines and dietary supplements during the study. A baseline fasting blood sample, blood pressure measurements, and anthropometric indices will be obtained. Subsequent assessments will be made at four-week and eight-week intervals.

Eligibility Criteria:
Inclusion Criteria:

* Fasting serum triglycerides 150-499 mg/dL,
* Body mass index 25-40 kg/m2
* Age range 18-75 years

Exclusion Criteria:

* Regular use of drugs of the fibrate family, fish oil supplements or omega-3 supplements
* Regular consumption of flax seed or chia seed
* Treatment with glucocorticoids
* End-stage renal disease
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss

The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.

Male subjects with androgenetic alopecia were enrolled in this fourteen-center trial. Subjects were randomized to use either 5% minoxidil or placebo foam twice daily for 16 weeks. A total of 143 subjects continued use of the 5% minoxidil foam for 8 to 12 months in an open-label phase to obtain safety data on 5% minoxidil topical foam when used twice daily for up to one year.

The 5% minoxidil foam was shown to be effective in the treatment of male androgenetic alopecia in a 16 week trial. It was statistically significantly superior to placebo foam in the primary efficacy measure of mean change in the non-vellus hair count in the target region between Baseline and Week 16, and the subject rating assessed an overall improvement from Baseline.

The efficacy of 5% minoxidil compared to placebo was confirmed by the secondary efficacy endpoints of scores from the expert panel review of hair regrowth when comparing photographs obtained at Baseline with photographs obtained at Week 16, as well as the percent change from Baseline in non-vellus hair counts within a pre-specified area of clipped hair.

The 5% minoxidil foam formulation was well tolerated, the incidence of adverse events was similar between groups, and no safety concerns were raised based on clinical laboratory test results, vital signs or scalp irritation scores.

Eligibility Criteria:
Inclusion Criteria:

* presence of androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale
* Male sex, age 15 to 49, good health
* Willingness to have a dot tattoo placed in the target area of the scalp during the study
* Willingness to maintain normal shampooing habits and products during the study
* Willingness to maintain the same hair style, approximate length, and hair color throughout the study

Exclusion Criteria:

* Known sensitivity to the investigational product
Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High prevalence in southeast and eastern Asia has been observed. At present, the cellular and molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear.

The RAS gene product has a key role in controlling cell growth and differentiation through its intrinsic GTPase activity. Point mutations that activate the RAS protein and its downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals. Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer and lung cancer. Studies from European and Japanese groups have recently described that activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF mutation in the same tumor as well as the results from Thailand. In this study, the investigators hypothesize copy number changes rather than genetic mutation of either KRAS or BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary tracts.


Eligibility Criteria:
Inclusion Criteria:

* The patients diagnosed as biliary tact adenocarcinoma.
Anastrozole 1 mg Tablets Under Fed Conditions

The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals, USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fed conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, post-menopausal or surgically sterile female subjects 18 years of age or older.
* Body mass index between 18 and 30, inclusive.
* Indicate non-child bearing status by one of the following criteria:

  * Indication of successful hysterectomy.
  * No spontaneous menses for at least 1 year, must have luteinizing hormone (LH) and follicle stimulation hormone (FSH) levels within the postmenopausal range.
  * Indication of successful bilateral oophorectomy.
* Negative for:

  * HIV.
  * Hepatitis B surface antigen and Hepatitis C antibody.
  * Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines, and methadone).
  * Urine cotinine test.
  * Serum pregnancy test.
* No significant diseases or clinically significant findings in a physical examination.
* No clinically significant abnormal laboratory values.
* No clinically significant findings in the 12-lead electrocardiogram (ECG).
* No clinically significant findings from the vital signs measurement.
* Be informed of the nature of the study and given written consent prior to receiving any study procedure.
* Participants in this study will be unable to have children (i.e. post-menopausal, hysterectomy).

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition.
* Known or suspected carcinoma.
* Known history or presence of:

  * Hypersensitivity or idiosyncratic reaction to anastrozole and/or any other drug substances with similar activity.
  * Alcoholism within the past 12 months.
  * Drug dependence and/or substance abuse.
  * Use of tobacco or nicotine containing products within the last 6 months.
* Taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
* Taken any hormone replacement therapy (HRT) for 4 weeks prior to dosing.
* On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
* Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
* Donated up to 250 mL of blood within the previous 30 days OR donated from 251 to 500 mL of blood in the previous 45 days OR donated more than 500 mL of blood in the previous 56 days.
* Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
* Difficulty fasting or consuming the standard meals.
* Do not tolerate venipuncture.
* Unable to read or sign the Informed Consent Form.
Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS on COVID-19 Pneumonia Requiring Mechanical Ventilation

The new coronavirus pandemic responsible for the severe acute respiratory syndrome SARS-CoV2 requires, in its severe forms, the use of invasive ventilation in intensive care.

The first patients seen in intensive care presented with neurological symptoms and usually not seen in non-viral ARDS or due to other viral causes. These were mainly restless awakenings, attempts at self-extubation and confusional syndromes. Although the data in the literature do not seem to reveal the presence of SARS-CoV2 in the CSF of these patients, certain elements seem to show parenchymal brain damage with the description of hypometabolism of the frontal regions. In addition, most of these patients present a memory complaint after going into intensive care (personal data not published).

We do not know to date what is the cognitive and psychic profile of these patients, nor what will be their future evolution. Some patients may require specific neuro-cognitive rehabilitation.

The aim of this study is to assess the cognitive profile of patients infected with COVID-19 who have used invasive ventilation in the intensive care unit of Paris Saint-Joseph hospital since April 2020, in order to be able to compare them between them and follow their evolution in the medium term. This work could make it possible to describe the specific cognitive impairment of SARS-CoV2, by trying to evade other causes of cognitive disorders in patients hospitalized in intensive care for respiratory distress (hypoxia, treatments, metabolic disorders, etc.).

The main objective is to follow the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of SARS-CoV2 with the use of ventilatory resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patient with SARS-CoV2 treated in the intensive care unit of the HPSJ for respiratory distress, using invasive ventilation by oro-tracheal intubation from April 2020
* French speaking patient

Exclusion Criteria:

* Patient with an alertness disorder with Glasgow eye score \<3 and / or motor \<6 (confusion being a poor criterion for evaluating the Glasgow score apart from head trauma).
* Patient with impossibility to communicate (mutism, aphonia, major language barrier)
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient objecting to the use of his data for this research
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures

This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice. This will be assessed postoperatively following the foot and ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament reconstruction (LAR).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to have either lateral ankle ligament reconstruction (LAR) surgery or primary first metatarsal osteotomy surgery
* Patients who agree to be compliant and to keep a patient diary daily for 2 weeks and to return to the clinic for a 2 week postoperative follow- up appointment

Exclusion Criteria:

* Patients with Diabetes Mellitus, peripheral vascular disease, Reynauds Syndrome, hypersensitivity to cold
* Patients allergic to hydrocodone or oxycodone
* Patients who are unwilling to complete the patient diary and/or follow their specific cold therapy instructions
Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
* ASA 1,2,3
* females who have started menses but have a negative urine pregnancy test

Exclusion Criteria:

* patients with known dysrhythmias,
* not recovering in the ICU
* developmental delay,
* autism communication disorder
* bleeding disorder
* PI discretion
EORTC-endorsed, Prospective European Multicenter Imaging Survey and Protocol

A prospective, multicenter imaging Delphi survey among European radiological societies for mCRC imaging standardization.

BACKGROUND: Computed Tomography (CT) is the imaging reference standard for initial staging and response assessment in randomized, controlled clinical trials (RCT) dealing with metastatic colorectal cancer (mCRC). However, comparability of imaging data among recruiting centers in RCTs is highly hampered by diverging imaging protocols and different technical specifications. Over the last years, analysis of radiomic features in mCRC patients has gained increasing interest for image evaluation beyond the mere assessment of extent. Also, these radiomic features are highly susceptible to technical parameters such as slice thickness. Hence, comparability of radiomic features among recruiting centers are also highly limited due to diverging imaging protocols.

AIMS: This prospective, multicenter imaging survey aims at assessing current differences regarding mCRC CT imaging protocols and technical specifications among large academic sites in Europe and at drafting a consensus imaging protocol endorsed by the European Organisation for Research and Treatment of Cancer (EORTC).

METHODS: This survey will be in close cooperation of the EORTC Imaging Group, EORTC Gastro-intestinal Tract Group, European Society of Oncologic Imaging (ESOI) and European Society of Gastrointestinal and Abdominal Radiology (ESGAR). Among the EORTC Imaging Group, EORTC Gastro-intestinal Tract Group, ESOI and ESGAR, imaging experts will be prospectively recruited and will serve as expert panelists in this prospective survey. Following the Delphi approach for survey conduction, several survey rounds will be performed. The answers of each survey round will be analyzed by the survey facilitators, blinded results will then be forwarded to the expert panelists prior to every following survey round. Statements / answers can then be modified by the expert panelists in the following survey round.

Eligibility Criteria:
Inclusion Criteria:

* Researchers / academics with expertise in gastro-intestinal / oncologic imaging
* Association with EORTC Imaging Group, EORTC GI Group, ESGAR or ESOI.

Exclusion Criteria:

* Participants not meeting the inclusion criteria
Treatment of Acute Myeloid Leukemia (AML) in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 2

Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2

Patients from 50 to 70 years with de novo AML were randomized to receive ARAC 200 mg / m² / d IV x 7 d with either DNR 80 mg/m²/dx3d (arm 1) or IDA 12 mg / m²/d x 3 d (arm 2) or 4 d (arm 3). The pts received a failing course of remedial Mitoxantrone involving x 2 and j ARAC 1g / m 2 x / d x 4 days The pts in CR then received 2 courses of consolidation with, according to initial randomization either DNR 80 mg / m² IDA 12 mg / sqm x 1 d (1st treatment) or 2 d (2nd treatment) and ARAC 1 gsm 2/jx x 4 days The pts in CR were then randomized persistent IL2 (5 million IU / m² x 5 d / month in SC for 12 months) or no treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient from 50 to 70 years
* AML de Novo
* No prior therapy for AML
* Absence of severe infection (WHO grade greater than 2), independent of the AML
* Cardiac function determined by radionucleotide or echography within normal limits.
* total bilirubin less than or equal 2N and Serum creatinin less than or equal 2N
* ECOG performance status 0 to 3
* Signed informed consent.

Exclusion Criteria:

* M3-AML
* history of neoplasia treated by radiotherapy or chemotherapy
* Myelodysplasia diagnosed more than 6 months before the diagnosis of AML
* Prior treatment for AML
* Uncontrolled infection
* Other active malignancy
* Patient unable to undergo regular surveillance
Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns

The aim of the study is to evaluate the effect of kangaroo care on physiological weight loss in term newborns.

The data collection process continues in a randomized controlled experimental study conducted to determine the effect of kangaroo care on physiological weight loss in term newborns. In the calculation made for the determined effect size, 80% power, 5% margin of error and one-way statistical significance, the experimental group was planned as 51 and the control group as 51 newborns. In this reporting period, 25 newborns as the experimental group and 30 newborns as the control group were followed up and interviewed with the mother.

Mothers who meet the criteria to participate in the research are informed about the research in the delivery room or in the first hours of delivery. The mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to.

Breastfeeding of the mother, the number and frequency of bottle feeding, kangaroo care, diuresis, defecation numbers and weight are recorded by following up. Physiological weight losses are determined by comparing birth weight with daily weight losses.

A cotton kangaroo care blanket is given to every mother who agrees to participate in the study, so that mothers can care for their kangaroos comfortably and to continue kangaroo care at home. These covers, prepared for kangaroo care, increase the motivation of mothers to participate in the study. In order to facilitate the follow-up of diuresis and defecation numbers, the family is supported in the evaluation of diapers (number, weight).

Eligibility Criteria:
Inclusion Criteria:

* Term babies born between 37-42 weeks of gestation
* Newborns born vaginally
* Newborns with developed sucking and swallowing reflexes

Exclusion Criteria:

* Newborns born with C-section
* Newborns in need of NICU care
* Preterm newborns (born \<37 weeks of gestation)
* Newborns in need of oxygen
* Genetic or metabolic disease (of the baby) limiting breastfeeding
* HIV (+) mother
* Mother having a chronic disease that will affect breastfeeding
* Mother using drugs that pass into the breastmilk and affect the baby
* Presence of a medical problem that will prevent the mother and baby from staying together
Assess Whether Knowledge by the Younger of the Function of the Accelerometer Determines Its Amount of Physical Activity

Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded and the non-blinded group. The blinded subjects will be informed that we were testing the reliability of a new device for body posture assessment and these youngsters will did not receive any information with regards to physical activity. Conversely, the non-blinded subjects were informed that the device was an accelerometer that assessed physical activity levels and patterns. Participants will be instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall duration and the duration relative to the quality of the physical activity patterns (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group during the 4-day monitoring, then compared between the two groups using the Student's t test.


Eligibility Criteria:
Inclusion Criteria:

* 10-18 years old adolescent
* normal clinical examination,
* normal nutritional status at baseline defined by a weight / height ratio between - 2 and + 2 DS DS

Exclusion Criteria:

* abnormal ECG
* known chronic disease
* acute infection dating back at least a week.