cyrilzakka/clinical-trials huggingface dataset:
Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is commonly observed in southern China, particularly in the Pearl River delta area and the Xijiang River basin in the Guangdong and Guangxi provinces, with an incidence rate as high as 25-50 per 100,000. The National Comprehensive Cancer Network guidelines (version 1, 2018), have recommended use of induction chemotherapy followed by CCRT as category 2A for NPC, especially the TPF regimen as category 1 for EBV-associated disease. The nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a promising new agent with more efficient entry to the tumor microenvironment and preferential uptake by cancer cells. Superior activity of Nab-paclitaxel regimens without the necessity for antianaphylactic pretreatments has been shown in various solid tumors compared with the traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of combination of Nab-paclitaxel, cisplatin and Fluorouracil (APF) has not been determined in patients with locoregionally advanced NPC. In this prospective, Multi-centeric, Open, Non-controlled phase II clinical trial, investigators perform an exploratory study to the efficacy and Safety of APF.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
2. Tumor staged as T3-4/N1-3 (according to the 8th UICC edition).
3. No evidence of distant metastasis (M0).
4. EBV positive.
5. Satisfactory performance status: ECOG≤2.
6. Adequate marrow: leucocyte count ≥4000/uL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
7. Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
8. Adequate renal function: creatinine clearance ≥60 ml/min.
9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
2. Age\>60 years or \<18 years.
3. Treatment with palliative intent.
4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
5. Pregnancy or lactation.
6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers

The primary objective of this study is to evaluate the systemic pharmacokinetics (PK) of LE (loteprednol etabonate ophthalmic gel), 0.38% in normal healthy volunteer subjects at least 18 years of age and with a normal ophthalmic history. Systemic PK will be assessed in this study after a single dose and after 2 weeks of daily BID dosing.

Eligibility Criteria:
Key Inclusion Criteria:

* Are able to read, understand and provide written informed consent on an Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
* Be a non-smoking male or female at least 18 years of age on the date the ICF is signed and with the capacity to provide voluntary informed consent.
* Be in general good health and free of any concomititant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or place the subject at increased risk during the study.
* Be willing/able to return for all required study visits and follow instructions from the study Investigator and his/her staff.
* Are able to self-administer eye drops or have a clinical staff member deliver the single dose of investigational product (IP) on specified study days.
* Have a normal physical examination and clinical laboratory evaluation

Key Exclusion Criteria:

* Have a history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject, confound the result(s) of the study, or preclude study treatment or follow-up.
* Have any current disease or medical condition that requires medicinal therapy.
* Have a history of drug or alcohol abuse in the last 6 months.
* Have a positive urine screen for alcohol, amphetamines, barbiturates, benzodiazepines, cocaine (or cocaine metabolite), cannabinoids, methadone, methamphetamine, opiates and/or phencyclidine.
* Are known to have a prior positive blood screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus types 1 and 2.
Sensory-Mechanical Responses to Eucapneic Voluntary Hyperventilation and Mannitol

The objectives of this study are to determine the sensory-mechanical responses to Eucapneic Voluntary Hyperventilation (EVH) and Mannitol in individuals with cough variant asthma (CVA) and methacholine-induced cough with normal airway sensitivity (COUGH) and compare these responses to a control group of healthy individuals without asthma or chronic cough.

We hypothesize:

1. EVH and Mannitol cause dyspnea, cough, small airway obstruction with resultant dynamic hyperinflation, gas trapping and autoPEEP in individuals with CVA and COUGH, but not healthy controls.
2. The sensory-mechanical responses to both hyperosmolar challenges (EVH and Mannitol) are comparable within groups (CVA, COUGH and healthy controls).

Asthma is a chronic respiratory condition characterized by eosinophilic airway inflammation. Individuals with classic asthma experience paroxysmal symptoms including cough, wheeze, shortness of breath and chest tightness. Cough variant asthma (CVA) is asthma in which chronic cough (cough lasting eight weeks or more) is the sole or predominant symptom of asthma. The pathophysiologic mechanisms which differentiate asthma, CVA, and eosinophilic bronchitis without asthma are not fully understood. We have recently identified individuals with chronic cough who cough during methacholine but have normal airway sensitivity (ie. do not have asthma or CVA) (COUGH) and may or may not have eosinophilic bronchitis. The purpose of this research is to further explore the pathophysiologic basis for cough in these conditions using two 'indirect' inhalation challenge tests: eucapneic voluntary hyperventilation (EVH) and Mannitol), which induce osmotic and/or temperature changes in airway. Specifically, this study will collect preliminary data on the sensory-mechanical responses of individuals with CVA, COUGH and healthy controls to EVH and Mannitol Challenges.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-65 years of age with CVA and individuals with methacholine-induced cough but normal airway sensitivity. The following definitions will be used:

  1. CVA: chronic cough (≥8 weeks) is the sole or predominant symptom and positive methacholine challenge (PC20 ≤ 16 mg/mL) and history of cough responding to specific asthma treatment (such as inhaled steroid or 1 week trial of bronchodilator);
  2. Methacholine-induced cough but normal airway sensitivity: chronic cough (≥8 weeks) is the sole or predominant symptom and negative methacholine challenges (PC20 \> 16 mg/mL).
* Individuals aged 18-65 years of age with no history of asthma or chronic cough.

Exclusion Criteria:

* an exacerbation necessitating a change in medication, emergency department visit or hospitalizations within the previous 4 weeks
* inability to perform acceptable spirometry
* medical contraindications to methacholine challenge testing
* smoking history in excess of 10 pack years Note: Previous treatment with inhaled or systemic corticosteroids is not an exclusion criterion; medication use will be recorded and examined in the analysis.
Effect of an Alumina Free Device Surface on BMD in Patients Implanted With an SL-PLUS™ Femoral Stem for THA

Alumina particles from the grit blasting of Ti-alloy stems for hip arthroplasty are suspected to contribute to aseptic loosening. An alumina-reduced stem surface was hypothesized to improve osseointegration and show comparable short-term outcomes to those of a standard stem.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older undergoing primary THA for primary or secondary osteoarthritis will be enrolled.

Exclusion Criteria:

* Exclusion criteria were ongoing therapy with cortisone or medications influencing bone metabolism.
Inadequate Emergence After Laparoscopic Surgery in Trendelemburg Position

The purpose of this study is to determinate if the patients submitted to laparoscopic surgery in trendelemburg position develope more inadequate anaesthesic emergence than patients submitted to laparoscopic surgery in other positions.


Eligibility Criteria:
Inclusion Criteria:

* laparoscopic surgery
* general anaesthesia
* trendelemburg positioning
* extubated in the operatory theater

Exclusion Criteria:

* unable of communicate
* dementia
* psychiatric history
* neurosurgery
* alchohol and drugs addictions
Preoperative and Intraoperative Factors Related to the Development of Ptosis After Retinal Surgery

The purpose of this study to is to determine the incidence of post-operative ptosis in patients undergoing vitreoretinal surgery. An additional purpose is to identify pre-operative and intra-operative factors which correlate to the development of post-operative ptosis in vitreoretinal surgery cases.

This study will evaluate patients who will undergo vitreoretinal surgery at UCSF Medical Center and San Francisco General Hospital. After informed consent has been obtained, the measurement of eyelid parameters such as levator function, palpebral fissure height, upper eyelid crease height, MRD1 and MRD2 will be collected at pre-operative and post-operative follow up visits. External eye photographs taken at each visit will be evaluated by a masked reader who will calculate the eyelid parameters. Dermographic data and intraoperative factors such as operative time and type of procedure will be collected. For statistical analysis, Repeated ANOVA, Paired t-test, Wilcoxon signed rank test, Chi-square test and Pearson's correlation analysis will be calculated with SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have vitreoretinal surgery from January 2013

Exclusion Criteria:

* Minors, younger than age 18.
* Patients who have pre-existing ptosis at baseline in the operative eye.
* Patients who are not able to cooperate with eyelid ptosis measurements
Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries

The aim of this study was to assess the effect of intrathecally injected 5 µg dexmedetomidine or 25 µg fentanyl as adjuvants to bupivacaine in low dose spinal anesthesia for unilateral arthroscopic knee surgeries, on post-operative urinary retention (POUR), time needed to reach sensory block at the tenth thoracic dermatome (T10), the maximum sensory level achieved, the onset of motor block, the intra-operative fluids given, the duration of sensory and motor blocks, time to micturition or insertion of an intermittent urinary catheter and the number of patients who needed an indwelling (Foley's) catheter. Seventy patients, ASA physical status I or II, from 21 to 50 years old, scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia, were randomly divided into two equal groups; the Bupivacaine- Dexmedetomidine group (BD) patients and the Bupivacaine-Fentanyl group (BF) patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and II
* aged 21-50 years
* scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia

Exclusion Criteria:

* Patients' refusal
* contraindications to spinal anesthesia
* patients with coagulopathy
* infection at the lumbar region
* pre-existing neurological deficits in the lower limbs
* known allergy to any of the study drugs
* urinary incontinence
* cysto-ureteric reflux
* patients with congestive heart failure
* patients with dysrhythmia
* patients with heart block
* diabetic patients
* patients on α2-adrenergic receptors antagonists
* calcium channel blockers
Video Education With Result Dependent dIsclosure

The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.

This study consists of two parts:

* Qualitative assessment:

  * This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review. Participation in the study will be considered complete after the interview is finished. The qualitative assessment study will recruit 20 total participants.
  * The data gathered from this study will inform the refinement and adaptation of the VERDI model for the subsequent randomized controlled trial.
* Randomized control trial:

  * A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling in 1000 participants

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
* Ability to understand spoken or written English or Spanish in a healthcare context
* Ability to understand and the willingness to sign a written informed consent document
* Black or Latinx (qualitative assessment study only)

Exclusion Criteria:

* Prior cancer genetic testing
* Prior germline genetic testing
* Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
* Currently pregnant
* Currently incarcerated
Classical Trigeminal Neuralgia and Sodium Channel Mutations

The most common cause of trigeminal neuralgia is considered to be a neurovascular contact. However, this etiological factor only seem to be present in half of the patient group. Thus the etiology of the other half is unknown.

Gain-of function genetic mutations in voltage gated sodium channels have been hypothesized as playing a role in the etiology of trigeminal neuralgia but it has yet to be confirmed. In recent years gain-of-function mutations have been identified as a causative factor in other pain-diseases presenting with trigeminal neuralgia phenotypic similarities.

The aim of this study was to indentify VGSC gene mutations, specifically SCN9A, SCN10A and SCN11A genes, in a group of well characterized trigeminal neuralgia patients.

Setting: The study will be conducted at The Danish Headache Center, Rigshospitalet - Glostrup, Denmark (inclusion of patients and written Informed Consent, patient interview, phenotyping/diagnosis, neurological examination, blood sample.

Departments of Neurology and Clinical Genomics of the Maastricht University Medical Center, Maastricht, the Netherlands: Targeted NG Sanger Sequencing

Eligibility Criteria:
3.1. Inclusion Criteria

Subjects of both sexes with TN must meet the following inclusion criteria to be eligible for participation:

1. Patients must be able to give Signed Informed Consent prior to study entry
2. Patients fulfilling of the ICHD-3 beta diagnostic criteria for classical TN.1
3. Age 18 years or older.
4. Age at debut \< 42 years and/or confirmed first-line relative with TN.
5. Respond to sodium channel blockers with a 50% reduction of pain intensity evaluated by both the patient and the examining physician using the visual analog scale (VAS).

3.2. Exclusion Criteria

Subjects will be excluded if one of the following exclusion criteria is met:

1. Psychiatric or mental illness of physical condition that might interfere with the ability of the patients to fill in the Informed Consent and questionnaires.
2. History of herpes zoster in the distribution of the trigeminal nerve ipsilateral to pain, multiple sclerosis or a space-occupying lesion.
3. History indicative of painful posttraumatic trigeminal neuropathy such as previous trauma, surgery or radiation to the trigeminal nerve ipsilateral to pain.
Scandinavian Mirena Insertion Nulliparous Trial.

In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women Mirena insertion planned as contraceptive method

Exclusion Criteria:

* Ongoing or suspected pregnancy;
* Ongoing or recidivating genital infection;
* Cervicitis;
* Cervical dysplasia;
* Malignancy in uterus or cervix;
* Confirmed or suspected hormone sensitive neoplasia including breast cancer
* Undiagnosed abnormal uterine bleeding;
* Uterine anomaly including myoma if the cavity of the uterus is restricted;
* Conditions that cause increased risk of infections;
* Acute liver disease or liver tumour;
* Allergy to the active substance or any component of the IUD
Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis

Sepsis is a significant public health concern worldwide, with high morbidity and mortality. With regard to a targeted antimicrobial treatment strategy, the earliest possible pathogen detection is of crucial importance. Until now, culture-based detection methods represent the diagnostic gold standard, although they are characterized by numerous limitations. Culture-independent molecular diagnostic procedures may represent a promising alternative. In particular, droplet digital PCR (ddPCR) is a novel one-step PCR assay that achieves higher accuracy and sensitivity in detecting causing pathogens in patients with bloodstream infections.


Eligibility Criteria:
Inclusion Criteria:

1.18 years or older

2.Meet 2 of 4 sepsis criteria

1. Temperature \> 38C or \< 36C
2. Heart rate \> 90 bpm
3. Respiratory rate \>20 or PaCO2 \<32mmHg
4. WBC \>12000/µL or \< 4000/µL or \> 10% bands

   3.Hospitalized patients who have a diagnostic blood culture ordered as standard of care for suspected sepsis

   4.Informed Consent by patient or legal representative.

   Exclusion Criteria:
   1. Refusal to participate in the study or Failure to comply with treatment or follow-up time
   2. Known breastfeeding or pregnancy
   3. The researcher believes that there are any conditions (social or medical) that allow subjects to participate is unsafe. For example, severe anemia or high risk of bleeding,etc., which are not suitable for taking peripheral blood for testing
   4. Participating in other clinical studies
Students Education Training in Emotional Connection

The purpose of this study is to assess the effectiveness of different educational modules in training graduate students from Columbia University Irving Medical Center campus and from the Columbia School of Social Work to assess the emotional connection of mother/child dyads with accuracy.

The investigators hypothesize that after completing the educational module involving recorded dyad interactions, subjects will achieve coding reliability with the PI.

The purpose of this study is to develop and test educational modules designed to instruct students how to assess the quality and strength of mother-child relationships. The approach will use constructs of Emotional Connection that were used in development of an investigational observation-based screening instrument, the Welch Emotional Connection Screen (WECS). The WECS allows healthcare providers to rate the emotional connection of a mother-child relationship in just a few minutes of observed face-to face interaction, and shows preliminary predictive properties when performed in the first year of life.

Administration of the WECS involves watching recorded interactions of a child sitting face-to-face on the mother's lap, and scoring the interaction on sliding scales per 4 domains. During the WECS development, the Nurture Science Program of Columbia University Irving Medical Center created and coded hours of parent-child interaction videos. These videos will be used to assess and train the students (subjects) on rating mother/child dyads around emotional connection. Subjects will rate the quality of mother-child relationships in video training sets after completing one of two educational modules: A) a lecture-style webinar describing evidence base and instructions on how to score the WECS B) a guide written in Clear Explicit Translatable Language (CETL). Training set results of students in these groups will be compared to results of students who received no prior training. Training set results will be analyzed for the reliability statistic between student scores and key scores established by writer of the scale and PI. Subjects will then spend 3 months without further training in emotional connection or practice coding WECS. Subjects will then rate the quality of mother-child relationships for videos of dyads they hadn't previously seen. The main outcome of this study is the comparison of reliability statistics and maintenance between students who completed different educational modules.

Eligibility Criteria:
Inclusion Criteria:

* graduate students from the Columbia University Irving Medical Center campus and from the Columbia School of Social Work

Exclusion Criteria:

* refusal to participate
Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project

The purpose of the JEMImE project is to create a serious game to help children with Autism and Pervasive Developmental Disorder (PDD) develop facial and vocal emotions in context.

The objective of this study is to record facial and vocal emotional productions in children with autism and PDD in order to create an algorithm for the recognition of facial emotional expressions implemented in the serious game JEMImE.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism and Pervasive developmental disorder according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria using scales (Autism Diagnostic Interview ADI and / or Autism Diagnostic Observation Schedule ADOS).
* Intelligence Quotient (IQ) = /\> 70 (Wechsler Intelligence Scale for Children WISC IV)
* Subjects and holders of parental authority who have given their informed and written consent
* Subjects affiliated to social security system.

Exclusion Criteria:

* Subjects non affiliated to social security system.