cyrilzakka/clinical-trials huggingface dataset:
A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread

The primary objective of this trial is to determine the maximum tolerated dose (MTD)/optimal biological dose (OBD) of BI 905681 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905681. The MTD will be defined based on the frequency of patients experiencing dose-limiting toxicities (DLTs) during the MTD/DLT evaluation period, which is defined as the first cycle of treatment. Separate MTDs will be determined for Schedule A and Schedule B.

The secondary objective of the trial is to determine the pharmacokinetic (PK) profile of BI 905681.

Study was opened to recruitment until 29-Oct-2021, however from 15-Apr-2021 no patient was recruited.

Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must have measurable or evaluable lesions (according to Response Evaluation Criteria in Solid Tumours (RECIST) v 1.1).
* Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options.
* Patients willing to undergo mandatory tumour biopsy at the time points specified in the protocol.
* Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1 (R01-0787).
* Adequate organ function defined as all of the following:

  * Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L; haemoglobin ≥9.0 g/dL; platelets ≥100 x 10\^9/L without the use of haematopoietic growth factors within 4 weeks of start of study medication.
  * Total bilirubin ≤1.5 x the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤3 x ULN or direct bilirubin ≤1.5 x ULN.
  * Creatinine ≤1.5 x ULN. If creatinine is \>1.5 x ULN, patient is eligible if concurrent creatinine clearance ≥50 ml/min (measured or calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula or Japanese version of CKD-EPI formula for Japanese patients).
  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x ULN if no demonstrable liver metastases, or otherwise ≤5 x ULN
  * Alkaline Phosphatase (ALP) \<5 x ULN
* At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.
* Signed and dated written informed consent in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
* Life expectancy ≥3 months at the start of treatment in the opinion of the investigator
* Further inclusion criteria apply

Exclusion criteria:

* Osteoporosis ≥ CTCAE Grade 2
* Osteoporotic compression fracture within 12 months prior to informed consent which is clinically significant in the opinion of the investigator.
* Further exclusion criteria apply
Rendering of a Local 1g Environment for Enhanced Motor Learning in Altered Gravity

Human motor adaptation is crucial to adapt to new environments, such as altered gravity. Dexterous manipulation and fine movements in space require learning new coordinated motor actions. Traditionally, adaptation mechanisms have been tested in laboratories with robotic devices that perturb specific task parameters unbeknownst to the participant. Over repetition, participants build a more accurate representation of the task dynamics and, eventually, improve performance. These perturbations are applied locally on the hand or limb while the dynamics of the rest of the body remains unaltered. These approaches are therefore limitative since they do not reflect ecological adaptation to globally changed dynamics, such as new gravitational environments. Parabolic flights, centrifuges and water immersion allow circumventing these limitations. Previous investigations in these contexts have highlighted the role of the global context in motor adaptation. However, it is unknown if global learning could benefit from exploiting known local dynamics. Here, we design an original task that will capture both the learning of arm movement kinematics as well as grasping forces for object manipulation in an ecologically valid design. We test whether executing this task in hypogravity with rendering of Earth gravity locally at the hand is beneficial or detrimental to task performance. By adopting the "negative picture" of conventional robotic approaches, these results will further our understanding of basic motor adaptation and provide insightful information on the optimal design and control of human-machine interfaces and wearable robots in space environments and other immersive dynamics.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women).
* Aged from 18 to 65.
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC).
* Who accepted to take part in the study.
* Who can take scopolamine or nautamine (medication against airsickness).
* Who have given their informed written stated consent.
* Who have passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination) and have been declared fit to fly. The examination must be less than one year before the experiment flight. There will be no additional test performed for participant selection.

Exclusion Criteria:

* Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated.
* Persons with any history of cerebral, cardiovascular or vestibular diseases.
* Persons with history of psychiatric diseases, including anxiety disorder.
* Persons whose medical condition has changed since the class 2-like medical examination.
* Pregnant women (urine pregnancy test for women of childbearing potential).
Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation

A previous study demonstrated topical lidocaine spray on the larynx and the trachea is effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In clinical practice, blind oropharyngeal application of lidocaine without aiding direct laryngoscopy can not assured that sprayed lidocaine effectively reaches the larynx and trachea. Therefore, direct laryngoscopy should be necessary to reach topical lidocaine to correct sites. Unfortunately, direct laryngoscopy itself can affect hemodynamics during spraying lidocaine. In this study, we will investigate an effect of lidocaine sprayed on direct laryngoscopy and the tracheal mucosa on hemodynamic change throughout intubation.


Eligibility Criteria:
Inclusion Criteria:

* aged 20-60 years,
* ASA groups I or II

Exclusion Criteria:

* ASA III or IV,
* hypertension,
* anticipated difficult airway, and
* severe coronary and cerebrovascular diseases
Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)

Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week).

The patients will be treated during 7 weeks with Pitolisant or placebo.

The treatment period (7 weeks double blind) will aim at demonstrating the efficacy of Pitolisant on the number of cataplexy attacks and the Excessive Daytime Sleepiness by verifying whether the results of Pitolisant are superior to those of placebo.

The safety will also be assessed.

Eligibility Criteria:
Main Inclusion Criteria:

* Narcoleptic with cataplexy : at least 3 weekly cataplexy attacks
* ESS \> or = 12
* ICF signed and dated

Main Exclusion Criteria:

* Other conditions that could generate EDS
* Psychological and neurological disorders
* Acute or chronic severe disease
* Treatment by prohibited medication
Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication

The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.

Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide lasting weight loss benefits to patients. We are projecting that the percent of Excess Body Weight Loss (% EWL) will be greater in study subjects when compared with our control group with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \> 35
* Meet ASMBS and NIH criteria for Weight Loss Surgery
* ASA Class I - III
* Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective procedure that would affect body weight for the duration of the trial.
* English speaking \& comprehension
* Normal mental caliber.

Exclusion Criteria:

* Pregnancy, Liver failure or Kidney failure
* Women of childbearing potential lactating at the time of initial consult or at the time of surgery
* Any condition which precludes compliance with the study
* History or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the Director of Bariatric Surgery.
Comparing the Number of False Activations Between Two Artificial Intelligence CADe Systems: the NOISE Study

One fourth of colorectal neoplasias are missed during screening colonoscopies-these can develop into colorectal cancer (CRC). In the last couple of years, Artificial Intelligence Deep learning systems were introduced in the endoscopic setting to allow for real-time computer-aided detection/characterization (CAD) of polyps with high- accuracy. Few CADe (detection) and CADx (diagnosis, characterization) have been therefore proposed with this purpose. Because CAD systems are based on deep learning where the computer directly learns polyp recognition from supervised data without any human-control on the final algorithm, their outcome incorporates some unpredictability in the clinical setting that must be cautiously interpreted after its application. This means that the endoscopist may be presented with FP images that he would have never been selected in the first place as suspicion areas. These FPs may hamper the efficiency of CADe-colonoscopy. Additional time may be required to discriminate between an actual FP and a possible false negative result. An excess of FPs may reduce the motivation of the endoscopist for CADe, leading to its underuse in clinical practice. Although the indications of a CADe must always be interpreted by physician, FP may result in unnecessary polypectomy with related adverse events when used without appropriate training. Yet, there is a lack of information among quantity and quality of False Positive signals provided by the systems. From a post-hoc analysis of a Randomized Clinical Trial, in which we extracted and analysed a video library of CADe-colonoscopy (GI Genius) performed in our institution Humanitas Clinical and Research Hospital IRCCS we aimed that False positives by CADe are primarily due to artefacts from the bowel wall. Despite a high frequency, FPs from this CADe system resulted in a negligible 1% increase of the total withdrawal time as most of them were immediately discarded by the endoscopists.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years
2. Ability to provide and to give informed consent
3. Boston Bowel Preparation Score \> 6 (\>2 each segment)

Exclusion Criteria:

1. Boston Bowel Preparation Score \< 6 (\<2 each segment)
2. Patients who had chronic inflammatory bowel diseases (such as Chron or Ulcerative Colitis)
3. Inability to obtain written informed consent
4. Patient unwilling to participate to the study
Oxygenation Test During General Anesthesia

The study investigates if applying a special ventilatory strategy during anesthesia for laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates oxygenation with blood gas samples but also with a new method that might give more information without the use of blood gas samples.

Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction and maintenance of anesthesia is performed with either a continuous positive airway pressure (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in comparison to a technique without CPAP but with a PEEP of 10 cm H2O.

Secondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative period if emergence from anesthesia is performed without high levels of oxygen.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective surgery of Morbid Obesity.
* ASA 1-2. (ASA = American Society of Anesthesiologists classification).
* "Body mass index" (BMI) ≥ 35 but \< 50

Exclusion Criteria:

* "ASA 3"
* Anticipated difficult intubation.
* Major bleeding.
* Problems with ventilation necessitating protocol aberrations.
* Obstructive sleep apnea syndrome with CPAP treatment at home.
* Angina Pectoris
Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)

The Chilean Maternal \& Infant Cohort Study II (ChiMINCs II) is an ongoing cohort that is part of the Chilean Maternal and Infant Nutrition Observatory of the South-East area of Santiago, Chile. In total, 1927 pregnant women beneficiaries of the public health systems and their offspring were recruited before 12 weeks of gestation and are followed across pregnancy (\<15, 26-28, and 35-37 weeks of gestation) and up to 2 years of age of their offspring. Two studies are currently nested in ChiMINCs II: 1) Breast Cancer Risk Assessment in Mothers (BRECAM) study, and 2) the ChiMINCs-COVID study. The primary objective of BRECAM study is to test the association between maternal metabolic indicators (i.e., insulin, glucose, IGF-1, and HbAc1 concentrations) at early pregnancy (i.e., \<15 and 26-28 weeks of gestation) and breast density 3 months after the cessation of lactation. For this purpose, we collect maternal obstetric, lifestyle, dietary intake, anthropometric, and biochemical information. The aim of the ChiMINCs-COVID study is to assess dietary-related risks and mental health problems derived from the COVID-19 pandemic and their influence on maternal and infant's health and nutrition. Thus, we collected detailed information on dietary behaviors, mental health and COVID-related information at each trimester, along with neonatal and infant nutritional information. The purpose of the present work is to describe the design, methods, and descriptive information at recruitment of ChiMINCs-II, also discussing the implications that this study can have to better understand maternal and infant nutrition and health during the COVID-19 era.


Eligibility Criteria:
Inclusion Criteria:

* 18 or more years of age
* Gestation \<15 weeks at first prenatal visit
* No intention to move outside the city of Santiago in the next to years

Exclusion Criteria:

* High-risk pregnancy (i.e., preeclampsia, pre- existing diabetes)
* Pre-existing cancer or family history of breast cancer
* Intended to migrate from the public to the private health care system
A Clinical Study to Evaluate the Safety and Efficacy of JHM03 in Adult Patients With Upper Limb Spasticity

This is a phase Ib/II clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type A（JHM03）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo in adult patients with upper limb spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
* Body weight ≥50Kg
* Participants with stable post-stroke Spasticity (ULS) for at least 3 months
* Participants with Modified Ashworth Scale (MAS) score of at least 2 at elbow flexor or wrist flexor or finger flexor
* Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain)
* Participants who have been stable for at least 1 month prior to study entry in terms of oral antispasticity

Exclusion Criteria:

* Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
* History of alcohol or drug abuse.
* Known allergy or hypersensitivity to any component of the study products.
* History of epilepsy
* Known or suspected to be HIV positive, serologically positive for syphilis, or active hepatitis B or C
* Any medical condition that may put the participant at increased risk for botulinum toxin type A use
Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer

The sentinel node has a fundamental role in the management of early breast cancer.

Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice.

So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough.

Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable.

The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proved infiltrating breast cancer (ductal, lobular carcinoma...) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy...)
* Unifocal or multifocal but in same quarter
* Size \< 5cm clinically palpable or not
* Clinically or ultrasound axillary N0
* Isotopic sentinel node detection
* Adult patient
* Signed informed consent by patient or legally responsable authority
* Patient registered to a social security system
* No surgical contra-indication

Exclusion Criteria:

* Mammary carcinoma recurrence
* Previous same side mammary reduction
* Previous lumpectomy
* Contra-indication to surgery
* Pregnant or breast feeding patient
* Denial of participation
Laser Acupuncture for Meniere Disease

Objective: To evaluate the effect of laser acupuncture for the patients Meniere disease.

Methods: We enrolled 324 patients at Beijing Tongren Hospital. Patients completed outcome measures at baseline, 3 months, 6 months, and 12 months. Video head impulse test (vHIT), The Caloric Test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry (PTA), and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of meniere disease.

Exclusion Criteria:

1. Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.
2. Planning for pregnancy, those in pregnancy, or those who were lactating.
The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus

evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.

The signs and symptoms of the oral lichen planus lesion. 2-The associated oral symptoms. 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis .

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of OLP

Exclusion Criteria:

1. lichenoid reaction from medication ' .
2. any systemic autoimmune disease
3. Pregnancy
4. smokers
Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography

The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA) and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general practitioner in Primary Health Care.

Pilot study that prospectively study a cohort of men over 50 years with cardiovascular risk factors: active smokers, former smokers, or hypertensive patients, attended in primary health care center. General Practitioner complete an ultrasonography training in an Ultrasound Unit under supervision of experienced radiologists using an standard ultrasound equipment and hand-held ultrasound (Trademark: VScan®, Manufacturer: General Electric, USA). All images and video recorded are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioner and radiologist. Kappa index is calculated to study the agreement on the presence or absence of AAA and AA-At. Logistic regression analysis is used to determine the factors that influence the presence of AA-At

Eligibility Criteria:
Inclusion Criteria:

* Smokers
* Former smokers.
* Hypertensive patients