cyrilzakka/clinical-trials huggingface dataset:
Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)

The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.


Eligibility Criteria:
Inclusion Criteria:

* Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities.
* ≥18 years of age who are able to consent.
* Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (\>1 year).
* Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can include one hospitalization or outpatient medical encounter with documented International Classification of Diseases (ICD9/ICD10) codes as identified within the Surveillance Case Definition.
* Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions.
* English as primary language (by self-report).

Exclusion Criteria:

* Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc.
* Patients who are participating in another study with an investigational drug within one month prior to screening.
* Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or \>12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan.
* Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion.
A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)

PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the progression of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 18-55 yrs.
* Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2010 revision of the McDonald Criteria.
* Expanded Disability Status Scale (EDSS) between 0-5, inclusive.

Exclusion Criteria:

* Relapse episode of MS within 2 weeks of enrollment.
* Primary progressive MS without a relapsing component.
* Intolerant or unwilling to undergo MRI scanning. Treatment with disease modifying agents up to 6 weeks prior to enrollment.
Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients

To investigate the impact of traditional Chinese medicines (TCM) on embryonic implantation in the patients who have underwent in vitro fertilization and embryo transfer, the investigators compare the pregnancy rate in traditional Chinese medicine group and control group. The hypothesis is that pregnancy rate in traditional Chinese medicine group is higher than the control group.

To demonstrate the impact of traditional Chinese medicine (TCM) on embryo implantation, the investigators perform a prospective randomized study on patients who have underwent in vitro fertilization and embryo transfer (IVF-ET) in the Reproductive Medical Center of the Remin Hospital Wuhan University in the next six months. These patients were randomly divided into two groups, one group was given traditional Chinese medicine, that is, ten days oral administration of Zhuyun recipe from the day after HCG injection. The second group without any treatment, and then the pregnancy rate were observed. Frozen embryo transfer for patients do the same treatment, measured indices were also the same in both groups. Our hypothesis is that Zhuyun recipe is beneficial for embryo implantation in IVF-ET patients, it can be found that pregnancy rate in traditional Chinese medicine group is higher than the control group.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-35 years old
2. undergo IVF/ICSI-ET treatment
3. undergo fresh/ frozen embryos transplantation

Exclusion Criteria:

1. the numbers of embryos transplantation were more than one
2. serum estradiol level \> 5000 pg/ml and progesterone level \> 9. 54 nmol/L on the day of HCG administration
Interscalene Dynamometer Pilot Study

Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain. Commonly, patients receive general anesthesia with interscalene block (injection of local anesthetic or numbing medicine near nerves in the shoulder) during surgery. As a result of the interscalene block, patients often experience sensory and motor blockade. The purpose of this study is to determine the effects of the interscalene block on the anterior deltoid muscle and hand grip strength after total shoulder arthroplasty.

Total shoulder arthroplasty can cause severe postoperative pain. Pain management includes general anesthesia with interscalene block during surgery and intravenous (IV) hydromorphone patient controlled analgesia (PCA) and oral opioid analgesics given after surgery. Side effects, such as motor blockade, may impair participation in physical therapy and diminish patient satisfaction. In order to prepare for a future study that will examine what mixtures of adjuncts/additives will best prevent recovery room pain and minimize motor blockade, the investigators are conducting this pilot study to collect preliminary data on current practice. The investigators believe the current regimen will provide adequate pain relief, but may cause extensive motor blockade and reduce patients' muscle strength after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for primary total shoulder arthroplasty
* Age 18 to 80 years old
* Planned use of general anesthesia via laryngeal mask airway (LMA) and peripheral nerve block
* Ability to follow study protocol
* Patients with American Society of Anesthesiologists (ASA) physical status of I, II or III

Exclusion Criteria:

* Patients younger than 18 years old and older than 80
* Patients not intending to receive general anesthesia and peripheral nerve block
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Hepatic or renal insufficiency
* Chronic opioid use (taking opioids for longer than 3 months)
The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury

Hypothesis: In this feasibility study, hyperoxemia, as approximated by transcutaneous hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary oxidative stress as demonstrated by elevation of pulmonary protein carbonyl. Furthermore, this oxidative stress will be directly proportional to the imposed oxygen-burden during resuscitation at the time of birth.

This study will give us information regarding the magnitude of protein carbonyl elevation in the preterm infant. With these results we will be able to 1. establish the technique for the running or protein carbonyl assays and 2. calculate an appropriate sample size for a future randomized control trial.

Immediately prior to birth, preterm infants (\<= 32 weeks gestation) will be randomized to one of three groups: 1. Low Oxygen Burden (LOB) - initiation of resuscitation with 21% 02, II. Moderate Oxygen Burden (MOB) - initiation of resuscitation with 100% 02 and III. High Oxygen Burden (HOB) - 100% 02 used for the entire resuscitation. A pulse oximetry monitor will be connected to a probe on the infant's hand to measure the transcutaneous hemoglobin saturation with oxygen (Sp02). Adjustments to the inspired oxygen concentration will be made every 15 seconds for infants in the LOB and MOB groups to achieve a target Sp02 range of 85-92%. Resuscitation will otherwise proceed as per standard of care. The intervention will end upon arrival in the neonatal intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* \<=32 weeks gestation
* inborn
* require intubation

Exclusion Criteria:

* lethal anomalies
* cyanotic congenital heart disease
* known hemoglobinopathy
* risk factors for persistent pulmonary hypertension
The Effects of Video Game Warm-up on EyeSi Surgical Simulator Performance

This study will examine the history of video game use an activities of manual dexterity with the scored skills used in the Eyesi surgical simulator. Subjects will be asked to participate in video games or no video games prior to testing skills in Eyesi to examine training effects of video game participation and changes in manual dexterity.

A popular crossover fighting video game released in 2001 for the Nintendo Gamecube that emphasizes reflexes and dexterity to perform specific maneuvers will be used in this study as a potential dexterity trainer.

The Eyesi is a training device utilized in many ophthalmology residency training programs to improve intraocular operative skills. The EyeSi is a validated training tool that uses high-end virtual reality that can be equipped with instrumentation for cataract or vitreoretinal surgery. The device itself consists of eyepieces that replicate a surgical scope, a mannequin head where handpiece probes can be inserted and position tracked to virtually recreate a surgical environment. The simulator also has a monitor that can be used to see the surgical simulator environment. As part of the software, numerous training tasks and exercises are available programmed into the device. These exercises utilize numerous metrics such as distance traveled, tissue treatment, efficiency, instrument handing, and others to provide the user with a raw score out of 100 for each task.

Subjects will then be asked to complete a manual dexterity questionnaire including history of video game use as well as tasks demonstrating manual dexterity ability such as the ability to play a musical instrument. Participants will then be randomized to the intervention group or the control group.

The intervention group will be asked to play 10 minutes of the Gamecube game "Super Smash Brothers Melee" as their "warm-up" prior to completing the EyeSi surgical tasks of navigation, forceps, and bimanual with their scores collected and averaged across all tasks.

The control group will complete the EyeSi surgical tasks of navigation, forceps, and bimanual with their scores collected and averaged, but will not perform a "warm-up" task.

Planned statistical analysis will include an average of total scores across navigation, forceps, and bimanual tasks. Chi square analysis will then be utilized to determine any statistical significance between intervention and control groups. Simulator scores will also be associated with questionnaire responses and simple linear regression will be used for analysis.

Eligibility Criteria:
Inclusion Criteria:

* UTMB Medical student volunteers who respond to email invitation to participate
* 18-40 years of age inclusive

Exclusion Criteria:

* Prior experience with EyeSi surgical simulator
* Not a UTMB Medical Student
* Not between 18-40 years of age inclusive
Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia.

OBJECTIVES:

* To perform high-resolution, genome-wide profiling of DNA copy number alterations and loss-of-heterozygosity in samples from adult patients with acute lymphoblastic leukemia (ALL) obtained at diagnosis.
* To perform candidate gene resequencing of diagnostic ALL samples.
* To examine correlation of genetic alterations with outcome.
* To examine the correlation between microarray multi-gene and multi-exon expression signatures with specific alterations and outcome.
* To understand genetic events that contribute to the formation, development, and relapse of adult ALL by integrating the copy number and sequence alterations with the multi-gene signatures, and by comparing these data with data already generated in pediatric ALL.

OUTLINE: Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients.

Eligibility Criteria:
Inclusion:

• Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10001, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)
Antiplatelet Effects in Stroke-Patients

Many patients suffer from acute and chronic pain. The incidence of chronic pain correlates with increased age. Most of patients rely on analgesic medication to control the pain. Dipyrone is an extensively used drug in Western and Eastern Europe as well as Central and South America, largely due to its favorable analgesic and antipyretic effects in conjunction with a low incidence of gastrointestinal complications when compared to other non-steroidal anti-inflammatory drugs (NSAIDs).

Aspirin is the backbone of antiplatelet therapy in patients after ischemic stroke. However, it is known that there are substantial inter-individual response variabilities to antiplatelet medication. Furthermore, patients with impaired response to aspirin have a significant higher risk of recurrent cerebrovascular events. The investigators have recently shown that co-medication with aspirin and dipyrone in patients with coronary artery disease lead to insufficient antiplatelet effects of aspirin.

The incidence of chronic pain is very high in patients with ischemic stroke. Therefore, in this study the investigators aim to examine, if co-medication of aspirin and dipyrone interaction also occurs in patients after ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with ischemic stroke and ASS-medication (80-320 mg/day) with/without analgesic comedication

Exclusion Criteria:

* Reanimation
* cardiogenic shock
Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.

multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.

The main criteria for evaluation will be:

* Efficacy
* Safety
* Microbiologic eradication

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained
2. Male or female ≥18 years of age
3. If female of childbearing potential, willing to practice reliable birth control measures and documented negative pregnancy test
4. Skin and skin structure infections of a complicated nature that require intravenous antibiotic treatment
5. Gram-positive infecting pathogen
6. Physician determination that vancomycin would be the initial treatment of choice
7. At least three clinical signs and symptoms associated with the cSSSI:

   * Pain;
   * Tenderness to palpation;
   * Elevated Temperature;
   * Elevated White blood count;
   * Swelling and/or induration;
   * Erythema (\>1 cm beyond edge of wound or abscess);
   * Pus formation;
8. Creatinine clearance of ≥50 mL/min.

Exclusion Criteria:

1. MSSA
2. Known or suspected bacteremia, osteomyelitis, or endocarditis
3. Primary study infection of an uncomplicated nature such as furuncles, simple abscesses, cellulitis not requiring i.v., perirectal abscess, hidradenitis suppurativa, third degree burn infections or other minor infections;
4. Conditions where required surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation);
5. Necrotizing infections or concomitant gangrene;
6. Myositis with or without skin and skin structure infections;
7. Hemodialysis or peritoneal dialysis;
8. BMI ≥40 kg/m2;
9. Previous antibiotics exceeding 24 hours within the 48 hours prior to the first dose of study drug
10. Patients admitted for rhabdomyolysis including drug overdose
11. Neutropenic patients with absolute neutrophil count ≤500 cells/mm3
12. Known HIV-infected patients with CD4 count ≤200 cells/ mm3;
13. Baseline CPK values ≥2 X ULN (upper limit of normal);
14. Has received an investigational drug within 30 days of study entry;
15. Known to be allergic or intolerant to study medications;
16. unlikely to comply with study procedures
17. Is expected to receive HMG CoA Reductase Inhibitors from enrollment through End of Treatment
Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy

The study aimed to compare the effects of bowel preparation methods of a normal diet for 1 day, a low residue diet for 1 day, and laxative bowel cleaning on the image quality of magnetically controlled capsule endoscopy, and to assess the rate of completion of the examination, small intestine transit time, lesion detection, patient tolerance, and safety of the three regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years, male or female
2. One of the following examination indications:

(1) Unexplained gastrointestinal bleeding; (2) Unexplained iron deficiency anaemia; (3) Suspected Crohn's disease or monitoring and directing treatment for Crohn's disease; (4) Suspected small bowel tumour; (5) Monitoring the development of small bowel polyposis syndrome; (6) Suspected or difficult to control malabsorption syndromes (e.g., celiac disease, etc.); (7) Detection of NSAID-associated small bowel mucosal damage; (8) Those with a clinical need to exclude small bowel disease.

Exclusion Criteria:

1. People who are ineligible for surgery or refuse to undergo any abdominal surgery (once the capsule is retained it cannot be removed surgically);
2. Known or suspected gastrointestinal obstruction, stenosis, and fistula;
3. People with implanted cardiac pacemakers or other electronic devices;
4. People with swallowing disorders;
5. Women during pregnancy;
6. People who are unable or unwilling to provide informed consent.
Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving epirubicin and cyclophosphamide followed by docetaxel and trastuzumab works in treating women with HER2-positive stage IIIB, stage IIIC, or stage IV primary breast cancer.

OBJECTIVES:

Primary

* Determine the pathological complete response in women with HER2-positive stage IIIB-IV breast cancer treated with neoadjuvant epirubicin hydrochloride and cyclophosphamide followed by docetaxel and trastuzumab (Herceptin®).

Secondary

* Determine the clinical response in patients treated with this regimen.
* Determine the recurrence-free survival of patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive epirubicin hydrochloride and cyclophosphamide in weeks 1-3. Treatment with epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. Patients then receive docetaxel in week 13 and trastuzumab (Herceptin®) in weeks 13-15. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 4 courses.

Patients then undergo appropriate surgery. After surgery, patients with hormone receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. Treatment continues for 40 weeks.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of primary breast cancer

  * Stage IIIB, IIIC, or IV disease
* No inflammatory disease
* HER2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization
* Hormone receptor status known

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Performance status 0-1
* WBC ≤ 10,000/mm³
* Absolute neutrophil count ≥ 2,000/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.5 g/dL
* SGOT/SGPT ≤ 60 IU/L
* Bilirubin ≤ 1.5 mg/dL
* Creatinine ≤ 1.5 mg/dL
* LVEF ≥ 55%
* No signs of pneumonitis

PRIOR CONCURRENT THERAPY:

* No prior surgery except for biopsy
* No prior or concurrent chemotherapy and/or hormonal therapy
* No prior or concurrent biological therapy
* No prior or concurrent radiotherapy except postoperative radiotherapy