cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.


Eligibility Criteria:
Inclusion Criteria:

1. Glioblastoma Multiforme (GBM)
2. 70 or above on Karnofsky Performance Status
3. Adequate bone marrow function
4. Recurrent GBM per RANO criteria
5. Subjects must have confirmed EGFR amplification by central lab

Exclusion Criteria:

1. For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
2. For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
3. Allergies to temozolomide, dacarbazine, IgG containing agents
4. Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
5. Subjects that have had more than one disease recurrence
Validation Study of Covariates Model (VaSCoM) for Propofol

Anaesthesia for surgical procedures can be provided using a continuous infusion of intravenous drug. The most commonly used drug for this technique is propofol. Infusion devices programmed with pharmacokinetic models can be used to infuse propofol to achieve a target blood concentration. These pharmacokinetic models predict the rate of distribution of propofol within the body and also the rate at which it is cleared. In practice, the anaesthetist enters patient details such as age, sex and weight as well as a target blood concentration of propofol. The infusion device then infuses propofol at the appropriate rate to achieve this concentration.

White and colleagues recently published the Covariates Model for propofol. It is anticipated that this model will have reduced bias and inaccuracy compared to the models in current clinical use. The VaSCoM study has three objectives:

1. Prospective validation of the Covariates Model
2. Modelling of the effect site concentration of propofol
3. Comparison of propofol concentration in venous and arterial blood samples

To achieve the above objectives, patients over 18 years of age and undergoing elective non-cardiac surgery will be recruited to the study. Anaesthesia will be delivered using a target controlled infusion device programmed with the Covariates Model for propofol. The target blood concentrations will be set according to a pre-determined schedule and all measurements will be made prior to the start of surgery.

Prospective validation of the Covariates Model will be done by comparing blood concentration of propofol predicted by the model to those actually measured. These results will then be compared to the predictions made using the models in current clinical practice.

Modelling of the effect site means predicting the concentration of propofol in the brain for a given blood concentration. This will involve using depth of anaesthesia monitors (such as bispectral index) as surrogate markers of brain concentration and comparing this to the predicted and measured blood concentrations of propofol.

Finally, important information on the distribution and clearance of propofol can be gained through the comparison of venous and arterial blood samples. In this study, simultaneous sampling of venous and arterial blood will facilitate this comparison.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* ASA I/II
* Elective non-cardiac surgery expected to last longer than 30 minutes

Exclusion Criteria:

* Patient refusal or unable to consent
* Premedication, sedative or anaesthetic in the previous 12 hours
* Pre-operative GCS less than 15
* ASA III/IV
* Allergy to constituents of propofol
* Excess alcohol intake
* Drug abuse
* Mental retardation
* Difficult airway
* BMI over 35
Study About the Evolution of Severe Late Onset Pompe Disease Patient With Pulmonary Dysfunction and Receiving Myozyme®

To describe severe late onset patients with pompe disease receiving Myozyme®


Eligibility Criteria:
Inclusion Criteria:

* Male or Female ≥ 18 years of age;
* The patient and/or patient's legal representative has given their informed consent in writing before any study procedure is initiated;
* Pompe disease confirmed by documented deficit in endogenous acid alpha-glucosidase (GAA) activity;
* A severe form of the disease as defined as follows: a. Moderate to severe limb girdle muscle weakness requiring help for walking around (sticks, crutches, walking frame or wheelchair); and b. Symptoms of diaphragmatic dysfunction defined by at least 2 out of the 3 following criteria: orthopnea, vital capacity \< 50%, paradoxical respiration detected in measurement of transdiaphragmatic pressure; and c. Use of invasive ventilation (defined by need for tracheotomy) or noninvasive ventilation (defined by utilization of assisted ventilation using a nasal or facial mask)day and night prescribed ≥ 12 hours/day;
* Treated for ≥6 months with Myozyme;
* Followed-up in a reference center according to the CETP recommendations.

Exclusion Criteria:

* The patient presents with a major congenital anomaly;
* The patient presents with a clinically important organic disease (except for symptoms related to Pompe disease) such as cardiovascular, hepatic, pulmonary, neurological or renal disease or any other medical condition, serious disease or particular circumstances that in the investigator's opinion, should preclude the patient's participation.
Comparison of Quality of Life in Patients with Differentiated Thyroid Carcinoma Undergoing Different Surgery

The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Early differentiated thyroid cancer has a good prognosis, and surgery is the main treatment. Traditional open surgery would leave a scar on the neck. However, emerging minimally invasive procedures can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.

This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing different surgery. The quality of life, voice, scar would be assessed by authoritative questionaires or scales. We hope to demonstrate that minimally invasive surgery is better than traditional open surgery in order to provide reliable evidence for clinical practice.

The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Differentiated thyroid cancer takes the largest proportion in thyroid cancer, but it has a good prognosis. For early differentiated thyroid cancer, surgery is the main treatment. Traditional open surgery would leave a scar on the neck, which is especially troublesome for female patients. However, emerging minimally invasive procedures, such as endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach, etc., can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.

This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing surgery according to a prospective cohort design. The evaluation questionnaires including quality of life, voice and scar would be completed to demonstrate that minimally invasive surgery is better than traditional open surgery not only in the way of effectiveness, but also in the quality of life. We hope to provide reliable evidence for clinical practice by this study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and \< 70 years;
* Biopsy or surgical pathology indicated differentiated thyroid carcinoma (papillary thyroid carcinoma, follicular carcinoma);
* stage T1\~T3a, N0\~N1a, M0;
* Ability to read and write Chinese;
* Willingness to follow up.

Exclusion Criteria:

* Age \< 18 years old or ≥70 years old;
* Biopsy or surgical pathology indicated medullary carcinoma or anaplastic thyroid carcinoma;
* Aggressive histology: tall cell, columnar cell, hobnail variant, etc.
* Mixed with medullary carcinoma or anaplastic thyroid carcinoma;
* High risk of recurrence (according to ATA guideline);
* Lateral cervical lymph node metastasis or distant metastasis;
* Suffer from other malignant tumors;
* History of thyroid surgery or cervical lymph node dissection;
* Cognition or behavior impairment.
Postpartum Weight Retention

The Postpartum Weight Management Study is a true community-academic collaboration, bringing together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith Wright from the University of Pennsylvania to address the needs of postpartum moms. The project is an innovative intervention to help moms lose weight after the birth of their baby. Helping mothers control their weight during pregnancy and beyond can help both mother and baby avoid later obesity and cardiovascular disease. Although all women are at risk for retaining the weight gained during pregnancy, this problem is amplified for low-income, minority women. The holistic approach aims to prevent postpartum weight retention and increase breastfeeding duration with a multi-component, low-cost intervention that provides: 1) Motivational appeals delivered in text message format; 2) Environmental aides, such as a baby carrier to combine exercise with infant care, and a pedometer to accurately measure exercise at home; 3) Enhanced peer support, including home visits and group classes with other mothers; and 4) Task-oriented professional support from nutrition and lactation experts, who assist women in developing a personalized health plan. The effectiveness of the intervention will be evaluated using a randomized control methodology among clients of MCC.


Eligibility Criteria:
Inclusion Criteria:

* All women who speak English, and are within six weeks of delivering a live, term, single infants

Exclusion Criteria:

* Women who have multiple births or preterm (\<38 weeks gestation) infants
Comparison of Chitodex Gel Vs NexFoam on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis

The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.

The trial will be single blinded randomized controlled trial and patients recruited will undergo endoscopic sinus surgery as standard of care for treatment of CRS. Specific outcome measures will be objective and subjective outcome scores post surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
2. ≥ 18 years to ≤ 90 years AND
3. English speaking AND
4. Able to give written informed consent AND
5. Local residents who will be returning to this center for postoperative follow-up care AND
6. Indicated to undergo endoscopic sinus surgery and willing to return at 2-4, 6-8 \& 12 (± 2) weeks post-op.

Exclusion Criteria:

1. allergy to shellfish
2. pregnant or breastfeeding
3. Hepatitis or blood disorders
4. any drug allergy
5. allergy to potato starch (due to Nexfoam)
RESTORE - Phase II

The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies.


Eligibility Criteria:
Inclusion Criteria (Implementation Group (Low Touch and High Touch)):

* Confirmed pregnant and \<20 weeks 0 days gestational age
* receiving care at one of the 10 clinics
* ≥18 years old
* able to speak and read English or Spanish
* Has a smartphone or mobile device with a data plan to accept text messages and internet connection to watch videos

Inclusion Criteria (Follow-up Group):

* Enrolled as a subject in the Implementation Group (Low Touch or High Touch) within the first trimester (before the end of the 13th week (13w6d))
* willing and able to provide consent for baseline and follow up surveys

Exclusion Criteria:

* Significant psychiatric or developmental disability as noted in the medical record.
A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies

UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification.

The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years of age (at the time of signing the ICF)
* Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months
* Moderate to severe active UC defined by Mayo Score ≥ 6
* Moderate to severe active UC defined by endoscopy score of ≥2
* Indication to start any biological or small molecule agent (anti-TNF, anti- IL12/23, anti-integrin and JAK-inhibitors)
* In case of treatment with corticosteroid: stable dose for at least 3 weeks prior to baseline, dosage ≤ 20 mg prednisone
* Indication for an endoscopy for the assessment of disease activity as for standards of care and current guidelines
* Able to comply with the study procedures
* Person affiliated to or beneficiary of a social security plan
* Person informed about study organization and able to sign informed consent form

Exclusion Criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis
* Absolute contraindications to endoscopy procedures or complication during previous endoscopy
* Bleeding disorders
* Indication for surgery for UC
* Rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline
* Treatment with \> 20 mg prednisone within 3 weeks prior to baseline
* Anaemia (haemoglobin \< 10 g/dl) at baseline
* Any circumstances which could contradict a study participation and lead the Investigator to assess the patient as unsuitable for study participation for any other reason
* Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:

  * Pregnant, parturient or breastfeeding woman
  * Minor person (non-emancipated)
  * Adult person under legal protection (any form of public guardianship)
  * Adult person incapable of giving consent and not under legal protection
* Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1
Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

In the present study, midazolam and palonosetron in combination were more effective than palonosetron alone in lowering the incidence and severity of postoperative nausea and vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical complications were not different in both groups.


Eligibility Criteria:
Inclusion Criteria:

* The patients (aged 20 to 65 years) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2

Exclusion Criteria:

* The patients with a history of allergy to any other drugs used in this study, gastrointestinal disorder, previous PONV, pregnant woman, breastfeeding woman, use of antiemetics within 24 hours or body mass index \> 30 kg/m2
Safety Study of BMS-770767 in Subjects With Type 2 Diabetes

The purpose of this study is to determine if BMS-770767 is safe, well tolerated, measure its levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes with inadequate glycemic control and treated with either diet and exercise alone, or with stable doses (≥ 1500mg/d) of metformin for at least 8 weeks prior to screening
* HbA1c ≥ 7.0% and ≤ 10.0% with FPG ≤ 240mg/dL (13.3 mmol/dL)

Exclusion Criteria:

* Women of childbearing potential
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* Significant cardiovascular history
* History of unstable or rapidly progressing renal disease
* Impaired renal function defined by a serum creatinine \> 1.4mg/dL (124 µmol/L) for women and \>1.5mg/dL (133 µmol/L) for men
* Active liver disease and /or significant abnormal liver function defined as AST \> 3X ULN and/or ALT \> 3XULN and /or serum total bilirubin \> 2.0mg/dl
Automated Dating Scan Probe Pressure Data Collection Plan

The goal of this observational study is to collect data in the form of ultrasound recordings from healthy volunteers, to aid the development of an Artificial Intelligence model that can identify ultrasound probe pressure.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.
Comparison of a Bilateral TAP Block and Preperitoneal Instillation of Local Anesthetic for a Total Extraperitoneal (TEP) Repair

Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under direct visualization will be compared it to a standard anesthetic technique (control) following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are hypothesizing that the bilateral TAP block and preperitoneal instillation of local anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction and post-operative pain control when compared to a standard anesthetic technique (no regional technique).


Eligibility Criteria:
Inclusion Criteria:

* 18-80 yrs of age
* American Society of Anesthesiologists (ASA) physical status 1-3
* Scheduled for outpatient TEP bilateral inguinal hernia repair

Exclusion Criteria:

* Patients refusal to participate
* inability to give consent
* drug allergies to medications used in study
* pregnancy
* bleeding diathesis
* conversion to an open procedure
* any subject whose anatomy, or surgical procedure, in the opinion of the investigator might preclude the potential successful performance of a TAP block
* any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a TAP block
Medical and Economical Evaluation of Computer-assisted Reconstruction of the Anterior Cruciate Ligament (ACL)

A poor outcome in anterior cruciate ligament (ACL) reconstruction is often related to tunnel position. The researchers believe that improving the accuracy of tunnel position will lead to an improved outcome in ACL surgery. The researchers' purpose is to perform a controlled study on a series of 500 patients in two groups: group I (250 cases) using conventional instrumentation and group II (250 cases) using navigation (Surgetics ACL Julliard protocol).

This study compares the percentage of patients in 2 groups (full success) at 1 year of follow up. The results were evaluated on clinical outcome based on the IKDC (International Knee Documented Committee, subjective evaluation) form between one group using conventional instrumentation and another group using navigation.

Secondary Aims:

* To compare in 2 groups:

  * Gain of IKDC score at one year (based on pre-operative IKDC score)
  * Evolution of IKDC subjective (pre-operative, at 12 months)
* To compare performances at one year (% class A or B) in terms of initial instability measured with laximetry score
* Study of the learning curve
* Evaluate: lasting quality, complication rate, extra-operative time
* Evaluate frequency of thrombovenous complications
* Evaluate delay to return to sport

Eligibility Criteria:
Inclusion Criteria:

* First knee surgery
* Patients more than 18 years old

Exclusion Criteria:

* Knee surgery already done
* Patients unable to understand informed consent sheet
Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements

Although the results of studies looking at tetrabenazine have shown its effectiveness in the management of hyperkinetic(too much) movement disorders, it has not been made available in the U.S. The drug must be obtained from Cambridge Laboratories, the distributor, using an individual IND (#16,161). The cost of the drug is passed on to the patient. The purpose of the protocol is to provide an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).

The purpose of the protocol is to provide compassionate use of an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).

Eligibility Criteria:
Inclusion Criteria:

* Subjects evaluated here at Baylor in the PDCMDC demonstrating need for tetrabenazine treatment.
* Willing to sign informed consent.
* Willing to comply with procedures required as part of this study.

Exclusion Criteria:

* Those subjects unwilling to comply with study requirements.
* Subjects unable to give informed consent.