cyrilzakka/clinical-trials huggingface dataset:
French Translation/Adaptation of AHEMD-SR (FR-AHEMD)

The aim of this study is to develop a French translation and adaptation of the original English version of the AHEMD-SR.

The AHEMD-SR was developed in 2005 to assess the opportunities offered to children aged 18 to 42 months to support their motor development in the home environment. The questionnaire is reliable and valid and is regularly used by researchers and practitioners to assess and develop strategies to improve the stimulating properties of the home. To date, the AHEMD-SR has been translated into eight languages, but no French translation exists.

The study will include a translation of the AHEMD-SR into French and a cultural validation of the French version of the questionnaire with a sample of parents of children diagnosed with delayed motor development and a panel of paediatric rehabilitation experts.

Eligibility Criteria:
Parents Group :

Inclusion Criteria:

* Parents of a child aged 18 to 42 months with a diagnosis of delayed motor development
* Taken in charge in one of the participating centers for an intensive motor rehabilitation training
* Francophone by birth

Exclusion Criteria:

* Parent opposing participation in the study

Experts Group :

Inclusion Criteria:

* Professional
* Holding a French state diploma in the field of rehabilitation
* Participating in an intensive motor rehabilitation training in one of the participating centres.
* Proof of experience in paediatric rehabilitation (lasting 5 years).
* Francophone by birth

Non-inclusion criteria :

- Expert opposing participation in the study
Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo for Advanced Squamous Cell Head and Neck Cancer

The purpose of this study is to determine if combination Erlotinib, Cisplatin/Carboplatin, and Paclitaxel are effective first line treatment for metastatic, recurrent and persistent squamous cell carcinoma of the head and neck.

We hypothesize that Erlotinib fails to enhance the effects of chemotherapy on response and survival because of Erlotinib's cytostatic effect, this results in a slowing down of the cell cycle, this in turn results in a hampering of the cytotoxic effect of chemotherapy leading to a lack of synergism with the combination. We propose that a sequential approach to the combination allows each drug to be used in its optimum time, by sequencing the Erlotinib, giving it 24 hours after chemotherapy we allow the chemotherapy to exert its effect with cells actively in cell cycle, but delivering the Erlotinib at a time when cells are trying to return to cell cycle hence slowing the growth rate of the tumor cell population. By withdrawing the Erlotinib about 4 days prior to the next chemotherapy cycle, we allow the cells to go back into cell cycle and therefore become susceptible to chemotherapy again.

Patients will be treated with intravenous paclitaxel over 3 hours followed by intravenous cisplatin/carboplatin on Day 1 of each 21 day cycle. Patients will be treated with Erlotinib at a loading dose of 300mg on Day 2 followed by 150 mg orally daily from Days 3-17 of each cycle of paclitaxel and cisplatin/carboplatin.

The primary objectives of this study are to assess the response rate of combination of erlotinib, cisplatin/carboplatin and paclitaxel in the first line treatment setting of metastatic, recurrent and persistent squamous cell carcinoma of the head and neck. Secondary objectives are to assess toxicity, median survival, and progression free survival.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma of the head and neck region that is metastatic, recurrent or persistent after surgery and/or radiation
* No prior chemotherapy for metastatic, recurrent or persistent disease

Exclusion Criteria:

* Not more than 1 prior adjuvant or neoadjuvant chemotherapy regimen is allowed
* Chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis

This is a phase IIb, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of MM-II in subjects with symptomatic knee OA as compared to matching placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is able to provide written consent, understand study requirements, is prepared to complete study procedures and is able to independently communicate meaningfully with study personnel
2. Presence of index knee pain for at least 6 months prior to Screening
3. Men or women ≥ 40 years of age at the time of Screening
4. Radiographic evidence of knee Osteoarthritis

Exclusion Criteria:

1. Pain in the contralateral knee with a severity of ≥ 30 mm on a 100 mm VAS
2. Presence of ≥ 40 mm on a 100 mm VAS pain in any other joints
3. Concomitant moderate or large size synovial fluid effusion of the index knee at Screening .
4. Known diagnosis of infection in the index knee in the past five years prior to Screening
JAK Inhibition in Food Allergy

This study will assess the role for an oral targeted medication, abrocitinib, as a new treatment option for food allergy patients that would avoid injections. Abrocitinib, which has successfully completed phase three trials for atopic dermatitis, could serve as a single therapy for two conditions in many patients with multiple atopic conditions.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 50 years old
* Participant must be able to understand and perform informed consent.
* IgE-mediated food allergy to at least one of the following foods as defined by (regarding at least one of the foods):

  ° Foods: peanut, cashew, walnut, hazelnut, sesame, cod, and/or shrimp, history of an acute allergic reaction (urticaria, angioedema, cough, wheeze, and/or repetitive vomiting within an hour of ingestion, and history of positive skin or serum IgE test, and current strict avoidance of the food, and current possession of physician-prescribed self-injectable epinephrine, and skin test wheal 5 mm or greater average diameter
* Current or past eczema.
* If female of childbearing potential, must have a negative pregnancy test (serum or urine) and agree to abstinence or acceptable contraception.
* Plan to remain in the Tri-State area during the trial for visits.
* Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sunlamps, or other ultraviolet (UV) light sources during the study.
* If receiving concomitant medications for any reason other than AD, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the duration of the study.

Exclusion Criteria:

* Unwilling or unable to give written informed consent or comply with protocol.
* Unable to swallow pill.
* Use of dupilumab within 6 weeks of enrollment.
* Prior use or allergy to drugs related to abrocitinib (ruxolitinib, upadacitinib, etc).
* Use of any other biologic (monoclonal antibody) medication within 12 weeks or 5 half-lives of drug, if known.
* Allergy to any excipients within abrocitinib.
* Use of build-up environmental immunotherapy; any food oral immunotherapy;or systemic oral, IV or IM steroids including but not limited to- prednisone, methylprednisolone, prednisolone, solumedrol, solucortef, dexamethasone in the past 4 weeks or 5 half-lives of drug, if known.
* Use of CYP2C9 and CYP2C19 inducers (such as carbamazepine, norfluoxetine, etc.) within 5 half-lives of the inducer plus 14 days prior to the first dose of study intervention.
* Use of CYP2C9 and CYP2C19 inhibitors within 1 week of first dose of study intervention or within 5 half-lives (if known) of the inhibitor, whichever is longer.
* Unable to stop long-acting antihistamines within minimum wash out period required for SPTs at screening and site visits
* History of or significant risk factor(s) for cardiovascular disease
Low-Dose Decitabine in Treating Patients With Symptomatic Myelofibrosis

RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying the side effects and how well low-dose decitabine works in treating patients with symptomatic myelofibrosis.

OBJECTIVES:

* Determine the efficacy and safety of low-dose decitabine in patients with symptomatic primary myelofibrosis (PMF) or post essential thrombocythemic (ET) or polycythemic vera (PV) myelofibrosis.
* Analyze the ability of this drug to decrease pathologic angiogenesis and other stromal reactive features intrinsic to PMF or post ET/PV myelofibrosis.

OUTLINE: Patients receive low-dose decitabine IV over 1 hour on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial remission, complete remission, or clinical improvement may receive up to 12 courses of decitabine in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for up to 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histological confirmation of primary myelofibrosis or post essential thrombocythemic or polycythemic vera myelofibrosis

  * Reticulin fibrosis ≥ grade 1
* Evaluable and symptomatic disease worthy of treatment, characterized by ≥ 1 of the following:

  * Anemia, defined as hemoglobin \< 11 g/dL or erythrocyte transfusion dependence
  * Palpable and symptomatic splenomegaly (palpable and symptomatic hepatomegaly is acceptable if previously splenectomized)
  * Severe, disease-related constitutional symptoms, including ≥ 1 of the following:

    * Severe night sweats
    * Fevers
    * Weight loss
    * Bone pain
* Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics OR prior demonstration of a lack of this translocation

PATIENT CHARACTERISTICS:

* Eastern Co-operative Oncology Group (ECOG) performance status 0-3
* Absolute neutrophil count (ANC) ≥ 1,000/mm³
* Platelet count ≥ 50,000/mm³
* Creatinine ≤ 2.0 mg/dL
* Direct or total bilirubin ≤ 2.0 mg/dL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN if elevation is attributed to hepatic extramedullary hematopoiesis)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Not incarcerated in a municipality, county, state, or federal prison
* No serious medical condition or psychiatric illness that would preclude signing the informed consent
* No condition that, in the opinion of the treating physician, places the patient at unacceptable risk for study participation or confounds the ability to interpret study data
* Able to adhere to the study visit schedule and other study requirements

PRIOR CONCURRENT THERAPY:

* No other concurrent chemotherapy (e.g., hydroxyurea, thalidomide, interferon alpha, anagrelide, or other myelosuppressive agent) or experimental therapy
Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

The primary objective of the present investigation is to determine the accuracy of a non-invasive non-oscillometric blood pressure wristband device when compared to invasive intra-arterial blood pressure monitors. In an intensive care unit patients who already have an intra-arterial blood pressure monitor in place, this wristband device will be applied and blood pressure readings compared for approximately 15 minutes. Blood pressure readings will be gathered and compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Surgical Intensive Care Unit who are already fitted with an invasive Arterial Line (A- Line) are eligible for the trial, and no volunteers candidates for an A Line are requested.

Exclusion Criteria:

* Within the candidate group of individuals whose procedure in the hospital requires an A-Line, the wristband may not, for various reasons, produce a clean signal. This is immediately determined after wearing the band (and may be related to the size of the wrist of the subject, among other things). Such candidates will be excluded from admission to the study.
* All data from a subject shall be excluded if the invasive reference systolic blood range is greater than 20 mmHg (2, 67 kPa) or if the invasive reference diastolic range is more than 12 mmHg (1, 6 kPa) in any single determination.
Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

The actual quality of Red Blood Cells (RBCs) salvaged during spinal deformity surgery has never been rigorously evaluated. To characterize the usefulness of intraoperatively salvaged RBCs in spinal deformity surgery. The study team hopes to answer the following questions: 1) What is the quality of RBCs salvaged during spine surgery? 2) Does intraoperatively transfused RBC salvage impact clinical outcomes?


Eligibility Criteria:
Inclusion Criteria:

* Any/all patients undergoing spine surgery who utilizes Cell Saver and has blood to be given back.
* This will include pediatric patients 0-17 as well as adults of any age who have been indicated for surgery.
* Only patients with the capacity to consent will be included.

Exclusion Criteria:

* Patients indicated for spinal surgery without the use of Cell Saver.
Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema

The primary objective of this study is:

* assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE

The secondary objectives are:

* evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for acute attacks of HAE
* assess the efficacy of ecallantide in paediatric patients treated for moderate to severe acute attacks of HAE


Eligibility Criteria:
Inclusion Criteria:

1. Male or female from 2 years of age and prepubertal
2. Physician diagnosis and history of HAE (Type I or II) including laboratory results showing C1-1NH activity below the lower limit of normal or up to 15% above the lower limit of the normal range
3. Present at the site with moderate to severe signs and symptoms of an acute attack of HAE within 8 hours of recognition of the onset of the attack. Spontaneous resolution of the attack must not have begun before the administration of study drug.
4. Must have signed informed consent by parent or caregiver.

Exclusion Criteria:

1. \<2 years of age or have reached puberty
2. Received treatment with ecallantide within previous 72 hours
3. Received an investigational drug or device, other than ecallantide, within 30 days prior to the screening visit
4. Pharyngeal/laryngeal symptoms
5. Mild attacks including mild edema of the extremities and mild abdominal attacks
6. Are unable or unwilling to give informed consent (parent or caregiver)
7. Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study
Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study

To observe the effect of intraoperative dexmedetomidine on the incidence of postoperative delirium, postoperative analgesic drug requirements and pain scores in elderly patients undergoing robot-assisted pancreaticoduodenectomy.

This study is a multicenter, randomized, double-blind, placebo-controlled trial. Three hundred patients undergoing elective robotic-assisted pancreaticoduodenectomy were randomized to the intervention and control groups. Patients in the intervention group were given a loading dose of 0.6 μg/kg of dexmedetomidine by intravenous infusion within 10 minutes after intubation, followed by a continuous infusion at a rate of 0.4 μg/kg/h until 30 min before the end of the procedure; patients in the control group were given an equal volume of saline. Data were collected at 1-5 days and 1 month postoperative follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years old
* Patients undergoing elective robotic-assisted pancreaticoduodenectomy.
* Written informed consent was obtained.

Exclusion Criteria:

* Patients with severe preoperative cognitive impairment (MMSE ≤ 20) who are unable to undergo a follow-up evaluation.
* Patients with history of psychiatric or neurological disorders.
* Patients with body mass index ≤ 18 or ≥ 30
* Pregnant or lactating women
* Patients with severe bradycardia (heart rate less than 40 beats per minute)
* Patients with pathological sinus node syndrome or grade 2 or greater AV block
* Patients with severe hepatic or renal insufficiency.
* Patients with severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent
* Index event of non-ST or ST segment elevation ACS

Exclusion Criteria:

* Index event is an acute complication of percutaneous coronary intervention
* Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
* Oral anticoagulation therapy that cannot be stopped
* The conditions associated with increased risk of bradycardiac events
To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)

A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects

CT-P6 SC, containing the active substance trastuzumab in combination with rHuPH20, is being developed by CELLTRION, Inc. (hereafter, the Sponsor) as a proposed biosimilar to the reference product, EU-approved Herceptin SC. The primary amino acid sequences of trastuzumab in CT-P6 SC are identical to those of the reference drug (EU-approved Herceptin SC). The CT P6 drug product will have the same pharmaceutical liquid formulation form and strength as the reference product's vial for SC injection and is intended to have a highly similar quality profile to the reference product.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subject between 19 and 55 years of age
2. Body weight between 60 and 90 kg, BMI between 18.0 and 29.9 kg/m2
3. Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information. The subject has the ability and agrees to cooperate with the investigator and must sign and date the written informed consent prior to performing any of the Screening procedures.
4. Subject who is sexually active with a woman of childbearing potential must agree to use a highly effective and medically acceptable methods of contraception consistent with local regulations during the course of the study and for 7 months after administration of the study drug (Day 1). Examples include the following:

   1. Condom with or without spermicide
   2. True abstinence, when this is in line with the preferred and usual lifestyle of the subject
   3. Or, a female partner with hormonal contraceptive or barrier method

Subject who has been surgically sterilized for less than 24 weeks prior to the date of informed consent and his female partner of childbearing potential must agree to use any medically acceptable methods of contraception.

Exclusion Criteria:

* A medical history and/or condition that is considered significant
* Clinically significant allergic reactions, hypersensitivity
* History or congestive heart failure, NYHA class ≥ class II
* Current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
* History or current of malignancy
* Previous exposure to trastuzumab or any drugs including Human epidermal growth factor receptor 2 (HER2) targeted monoclonal antibodies
* History or current use of recombinant human hyaluronidase (rHuPH20) or drugs including rHuPH20
Apneic Oxygenation by Transnasal Humidified Rapid Insufflation Ventilator Exchange Obstructive Sleep Apnea Patients

The purpose of the study is to compare effectiveness of different methods of achieving oxygenation in obstructive sleep apnea patients. The investigators intend to compare transnasal humidified rapid-insufflation ventilator exchange (THRIVE) combined with nasopharyngeal airway with THRIVE alone.

With the increasing prevalence of obesity, the prevalence of OSA is also rising, ranging from 9% to 25% in the general adult population. Patients with OSA have features of an anatomically tricky airway due to a crowded collapsible pharyngeal space, compounded by physiological problems related to lower functional residual capacity and increased oxygen consumption, leading to faster oxygen desaturation. Meanwhile, patients with OSA, compared to patients without OSA, have a 3-4 times higher risk of difficult intubation, difficult mask ventilation, or both. Apnoea time is a potentially hazardous period during induction of anesthesia and it is particularly so in patients with OSA. OSA patients undergoing general anesthesia gave rise to many concerns and challenges, and strategies to extend the apneic time were required. Identifying the most effective method of oxygenating OSA patients can therefore significantly improve the safety of delivering general anaesthesia to these patients.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18 and 75 years requiring general anesthesia
* American society of Anesthesiologists (ASA) physical status classification system: I - III
* diagnosed as OSA.

Exclusion Criteria:

* Patients with chronic respiratory disease, uncontrolled hypertension, ischemic heart disease, congestive heart failure, increased intracranial pressure, gastroesophageal reflux disease,
* patients' arterial hemoglobin saturation \< 98% after preoxygenation,
* patients were nasal obstruction
* patients with previous or anticipated difficult facemask ventilation or intubation,
* patients with known allergy or contraindication to propofol, remifentanil, rocuronium, or midazolam.
* patients who were unable to give informed consent