cyrilzakka/clinical-trials huggingface dataset:
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients

This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy patients. 30 patients will be enrolled as an inpatient or outpatient.

Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have undergone total laryngectomy \> 6weeks prior and are suitable candidates for secondary TEP insertion would be recruited to the study. Insertion of the TEP will be done in primary setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months. All the patients will be evaluated clinically for a fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.

This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel trachea-oesophageal prosthesis for total laryngectomy +/- partial pharyngectomy patients. 30 patients will be enrolled as an inpatient or outpatient.

Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have undergone total laryngectomy \> 6weeks prior and are suitable candidates for secondary TEP insertion would be recruited to the study. Insertion of the TEP will be done in primary setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months. All the patients will be evaluated clinically for fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are surgically and medically fit for undergoing a total laryngectomy +/- partial pharyngectomy.
* Patients who have already undergone total laryngectomy +/- partial pharyngectomy and are willing for a secondary voice rehabilitation procedure.
* Patient signing the informed consent for procedure after understanding the details

Exclusion Criteria:

* Partial laryngectomy
* Near total laryngectomy
* Patient unfit for the procedure
* Patients not consenting for the procedure
* Patients utilizing alternative ways of post laryngectomy voice rehabilitation (for secondary insertion)
* Patients with stricture in pharynx (for secondary insertion)
* Partial pharyngectomy reconstruction, not permitting insertion of TEP
Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)

The purpose of study is to learn if consuming ≥30 grams or more of fiber per day can help pregnant women gain an appropriate amount of weight during their pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Women between 9 to 15 weeks pregnant
* BMI between 22.0 - 40.0 kg/m2 and between the
* Ages of 18-45 years
* Able to be recruited from the University of Kansas Medical Center (KUMC).

Exclusion Criteria:

* No Internet access
* Consuming more than 20 grams per day of fiber
* And/or with the following medical conditions during pregnancy:
* Pre-gestational diabetes
* Diagnosed with diabetes
* Pre-eclampsia
* Hypertension
* Other metabolic abnormalities
* Asthma
* Heart disease
* Smoking
* Drug abuse
* Pregnancies of multiples
Gadolinium Retention in Human Bone Tissue in Pediatric Patients

The purpose of this study is to compare contrast agents, Dotarem or MultiHance. The study will test to see how much of these two contrast agents are deposited in the bones or tissues of pediatric patients. The patients receiving contrast will then be compared against pediatric patients who have not received any contrast prior to cardiac surgeries.

When injected into the body, gadolinium contrast medium makes certain tissues, abnormalities or disease processes more clearly visible on a magnetic resonance imaging (MRI) scans and therefore gadolinium based contrast agents (GBCAs) are widely used in medical imaging. Recently, new evidence suggests that following GBCA administration, gadolinium can be deposited in body tissues even in the presence of normal renal function. Therefore, it is essential to ensure that significant accumulation of free Gd3+ is not occurring in the bones of children undergoing clinical contrasted MRI scans. This is particularly important for those pediatric patients who will undergo multiple repeated MRI exams throughout their lifetime and thereby be exposed to a large cumulative dose of gadolinium contrast. As the differences in stability between the various GBCAs may be a factor in gadolinium exposure, the primary objective of this study is to assess gadolinium deposition in the bones of pediatric patients in two patient groups: 1. patients who received IV administration of gadolinium contrast agent (Dotarem) and 2. patients who received IV administration of gadolinium contrast agent (MultiHance).

Once acquired the samples will be analyzed at an off-site facility, National Institute of Standards and Technology (NIST), using standardized equipment which has been certified for measuring gadolinium concentration in contrast agent samples. A signed agreement for the transfer of non-proprietary biological material between MUSC and NIST covers the transfer of the samples.

Eligibility Criteria:
Inclusion Criteria:

* Female or male pediatric patient (patients aged newborn to 18 years old at the time of the MRI scan).
* Patients who require cardiac surgery for clinical purposes and meet one of the following three criteria:

  1. Patients who have undergone a routine contrast-enhanced MRI using MultiHance contrast agent only for clinical purposes.
  2. Patients who have undergone a routine contrast-enhanced MRI using Dotarem contrast agent only for clinical purposes.
  3. Patients who have not been exposed to gadolinium-based contrast agent administration

Exclusion Criteria:

* Patient with abnormal renal function (defined as eGFR MDRD\<30 ml/min/1.73m2).
* Patient previously exposed to any other type of MRI gadolinium based contrast agent either at MUSC or at an outside facility
* Pregnant or breast feeding female patient
* Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, infusion pumps, cochlear implants metallic or others according to standard practice at MUSC).
Statin Therapy Versus Placebo Prior to Prostatectomy

This is a randomized trial comparing the effect of oral simvastatin versus placebo on targets of the mevalonate pathway in men undergoing a prostatectomy as planned management for prostate cancer. Observed tissue effects will be correlated with changes in serum cholesterol and low-density lipoprotein.

Prostate cancer patients that have chosen to undergo a prostatectomy as their primary treatment option will be recruited to this trial. Forty-four subjects will be randomized to either placebo or simvastatin (40 mg po/day) for 4 weeks prior to surgery. Serum samples will be obtained at baseline and immediately prior to prostatectomy. At prostatectomy, cancerous and benign prostate tissue will be microdissected and cryopreserved. Archival prostatectomy tissues will be used to construct tissue microarrays containing matched benign and malignant sections. The effect of HMG-CoA reductase inhibition on lipid raft cholesterol content and targets of prenylation will be determined. The incidence of apoptosis will be determined along with protein levels of mediators of apoptosis. Lastly the effect of statin therapy on cellular markers of proliferation will be determined.

Previously, we studied the effect of statin use on the risk of prostate cancer detection in a case-control study at the Portland VA Medical Center. Statin use was associated with a 62% reduction in cancer odds-risk (OR = 0.38, 95% CI 0.21-0.69). Although these epidemiologic and laboratory findings have generated enthusiasm for the study of statins in prostate cancer, no studies have examined the biologic effects of statins on prostate cancer in humans.

Hypothesis: Statin therapy prior to prostatectomy will successfully target the mevalonate pathway in the human prostate and this intervention will favorably alter tumor biomarker status.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostatic adenocarcinoma with Gleason 5 to 7 (3+4 = 7 accepted, not 4 + 3 = 7)
* Radical prostatectomy chosen as primary treatment for prostate cancer
* Age 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Other preoperative or prior treatment directed at prostate cancer (i.e., Radiation, hormonal therapy, cryotherapy)
* Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* History of or active liver disease or abnormal results of the baseline liver function test (\> 2 x normal)
* Current use of:

  * simvastatin
  * lovastatin
  * other HMG-CoA inhibitors
  * lipid-lowering agents
  * Amiodarone
  * Cholestyramine
  * Cholestyramine and colestipol (bile acid sequestrants)
  * Clofibrate and fenofibrate
  * Cyclosporine
  * CYP3A4 inhibitors
  * Danazol
  * Diltiazem
  * Gemfibrozil
  * Niacin ( 1 g/day)
  * Verapamil and Warfarin
* Known allergy or sensitivity to ingredients in simvastatin
Nurse AMIE: Addressing Metastatic Individuals Everyday

Determine the acceptability and feasibility of a supportive care software platform to improve quality of life and function in metastatic breast cancer patients. Acceptability will be defined as the proportion of women offered the intervention who agree to participate. Feasibility will be defined as the proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.

Goals of the Nurse AMIE software program are to regularly assess psychosocial, functional, and symptom needs among metastatic breast cancer patients and to provide appropriate interventions via YouTube style videos, weekly phone calls with a patient navigator at Penn State, and appropriate referrals to phone or in person consultations as needed. The proposed Nurse AMIE software program will allow for the provision of resources (YouTube style videos, audio files, exercises) to intervene on many of the common symptoms and challenges experienced by metastatic patients. This is an identified need on the part of both metastatic patients and their medical care teams. Finally, it will also allow patient navigators to check in with patients, reviewing responses to surveys, discerning whether new or different interventions are needed, and connecting women to palliative care and other services if additional care is warranted.

Eligibility Criteria:
Inclusion Criteria:

* Women with metastatic breast cancer
* ECOG performance score ≤3.
* English Speaking
* With sufficient vision/hearing or family support
* Willingness to be randomized

Exclusion Criteria:

* Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
* Patients who are receiving any other behavioral intervention
Comparison of Two Regional Anaesthetic Blocks for ERAS After Congenital Cardiac Surgery

The current study is designed to compare the perioperative analgesic efficacy of transversus thoracis plane block (TTPB) and Pecto-intercostal-fascial plane block (PIFB) in children undergoing cardiac surgery via median sternotomy

Sixty paediatric patients of either sex, aged 2-12 years, undergoing elective cardiac surgery via median sternotomy. Patients will be excluded from the current study in case of, refusal to participate, redo or urgent cardiac surgery, local infection of the skin at the site of needle puncture, allergy to bupivacaine, coagulation disorders, clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension, and when extubation is intentionally planned to be delayed. Patients will be randomly assigned to one of two equal groups, the PIF block group and TTP block group, each will include 30 patients, by a computer-generated randomization table and concealed sealed opaque envelopes.

Eligibility Criteria:
Inclusion Criteria:

* either sex, aged 2-12 years, undergoing

elective cardiac surgery via median sternotomy

Exclusion Criteria:

* refusal to participate, redo or urgent cardiac surgery, local infection of the skin at the site of needle puncture, allergy to bupivacaine, coagulation disorders, clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension
Arm Motor Control on Bi and Uni ADLs

This study is being performed to assess how certain chronic disabilities - stroke, upper extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from healthy subjects in their ability to perform ADLs. By studying the kinematics of the respective cohort of study participants as they are assessed performing common activities of daily living (ADLS), the investigators research team aims to better understand how impaired neural pathways, and pathways that have been impaired at various points along the pathway, deleteriously affect ADLs in patients with differing long-term disabilities.

Cross-sectional study comparing bilateral ADL activities for stroke survivors, SCI paraplegics, UE amputees, adults with CP, and healthy controls. The study participants will perform 4 ADL tasks with the BiAS passive robots. From these tasks, the BiAS robots will provide information regarding position, velocity, distance, displacement, etc. This, along with video information provided by the 3D Kinect and EEG neuroheadset, will be used as the basis of the investigators data and aid in informing members of the research team on how the respective impairments affected upper limb kinematics on ADL tasks.

Participation in the study will include the following steps:

1. Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
2. Pre-Assessments: A member of the research team will evaluate the subjects' upper extremity and assess their ability to use it. Subjects will be evaluated using a battery of assessments such as, but not limited to, the Box and Block, Pin and Prick, and grip strength using a dynamometer.
3. Break: Subjects will be given a 15 minute break.
4. BiAS passive robot system: Subjects will be introduced to the device and each wrist will be placed on to the end of each robot. As common therapy tasks are performed by the subject, the BiAS devices will collect the data along with the video from 3D Kinect, ECG gelled electrodes, and the EEG neuroheadset. After each of the 4 ADL activities, subjects will be asked about their level of exercise and discomfort, if any. After subjects finish all exercises with the BiAS, they will be thanked for their participation in the study.
5. Video and photos may be collected to determine subject quality of ADL movement.

Eligibility Criteria:
Inclusion Criteria:

Study will include subjects 18 years of age or older from any of the below groups:

* Stroke survivors, 3 months post event
* Upper extremity amputees, 3 months post event
* Cervical SCI (C-5 to C-7), 3 months post event
* Cerebral palsy participants
* Healthy participants

Exclusion Criteria:

* The inability to perform at least some aspects of ADL tasks such as drinking, pouring, pinching, and grasping.
* Severe spasticity
A Study of Single Dose RO6811135 in Healthy Volunteers

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers. Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135 or placebo subcutaneously.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, 18 to 45 years of age inclusive
* Body mass index (BMI) 22-32 kg/m2 inclusive
* Females of child-bearing potential and males with female partners of child-bearing potential must agree to use adequate contraception as defined by protocol

Exclusion Criteria:

* History or presence of any clinically relevant disease or disorder
* History of drug hypersensitivity or food allergies
* Significant infection or known inflammatory process at screening or Day -1
* Any history of alcohol and/or drug of abuse addiction
* Alcohol consumption of more than 14 units (1 unit = 10 mL of pure alcohol) per week
* Smoking more than 5 cigarettes a day or equivalent amount of tobacco
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in an investigational drug or device study within 3 months prior to screening
Analgesic Effect of Erector Spinea Plane Block Compared to Peritoneal Block in Laparoscopic Cholecystectomy

The aim of this study is to detect weather peritoneal block or erector spinae plane block will provide the most ideal analgesia for patients undergoing laparoscopic cholecystectomy. Peritoneal block by instillation of local anesthetic into the peritoneal cavity will act by blocking the free afferent nerve endings in the peritoneum and the systemic absorption of local anesthetic from the peritoneal cavity may also play a part in reduced pain.

On the other hand ,the erector spinae plane block is a novel analgesic technique that provide both visceral and somatic analgesia due to its communication with the paravertebral space. Local anesthetic mixture of lidocaine , magnesium sulphate and epinephrine will be used for both techniques.

The pain that a patient feels after laparoscopic cholecystectomy results from three different and clinically separate components: somatic pain due to trocar insertion sites , visceral pain due to surgical dissection and tissue handling at the gall bladder bed, and shoulder pain due to retention of carbon dioxide in the abdomen, which irritates the phrenic nerve and diaphragm. Ineffective treatment of post laparoscopic cholecystectomy pain may delay recovery and mandate inpatient admission and therapy and increase the cost of such care.

The aim of this study is to evaluate the analgesic effect of Erector spinea plane block in comparison with peritoneal block for laparoscopic cholecystectomy. Serum level of cortisol as a stress biomarker ,perioperative primary hemodynamics ,visual analogue scale , patient request for rescue analgesia and occurrence of side effects are the parameters for comparison between both techniques. Each patient will be followed up for 24 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* American physical status classes I and II

Exclusion Criteria:

* Patient refusal.
* Pregnancy
* Neuromuscular diseases (as myopathies, myasthenia gravies...)
* Hematological diseases.
* Bleeding diseases.
* Coagulation abnormality.
* Psychiatric diseases.
* Local skin infection at site of the block.
* Local skin sepsis at site of the block.
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2.
* Chronic renal disease.
* Chronic hepatic disease.
* Preexisting neurological deficit.
* Conversion to open cholecystectomy
* Excessively long surgical times (\> 90 min)
Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women

The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy and postpartum, and to record adherence barriers and facilitators.

Data of all consecutive pregnant women included in the adherence enhancing program of the Pharmacy, Department of ambulatory care \& community medicine, are collected. In this program, adherence is measured and enhanced by electronic monitoring, pill count, motivational interviewing and interdisciplinary collaboration. Electronic monitoring data are collected during pregnancy and postpartum, and compared. Barriers and facilitators are collected using interview's marks.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women
* HIV-positive
* Antiretroviral medication delivered in electronical monitors

Exclusion Criteria:

* Monitored period during pregnancy \< 1 month
Yeast Cells as Antioxidant-Producing Probiotics

The purpose of this study is to evaluate the efficacy of Baker's yeast extractions , probiotic antioxidant, in scavenging the oxidative stress status mediated damage on sperm motility,progressive motility and vitality as well as comparing this potency to that of Vitamin E in infertile men.

The practical part of the study took place from August 2020 to November 2021. The Study population was made up of infertile males attending Hawaa fertility center, banha city, Qaliubiya, Egypt.

40 study samples were collected from patients who indicated willingness to participate in the study and have had 3 to 7 days of sexual abstinence, using the masturbation method and ejaculated in wide mouthed plastic container as described by World Health Organization (WHO).

Samples were allowed to liquefy for 20 minutes and were examined for volume, viscosity, spermatozoa count by Neubauer haemocytometer , oxidative stress level measurement by Oxisperm, percentage of progressive motility and non-progressive motility and sperm vitality.

The Semen specimens were divided into ten equal fractions. First fraction was control, 0.1ml of liquefied semen mixed with 0.1ml Ham's F10 medium and incubated at 37o C for 30 minutes., 2nd: Vit. E, 3rd (Yeast extraction ( YE).Vitamin C was obtained from (Sigma, Germany), 3rd, 4th, 5th fractions (Vit. C. 1,2,3), 0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.02, 0.04, 0.06 mg/ml) Vitamin C respectively and incubated at 37o C for 30 minutes.

After semen specimen treated in all fractions, they were examined and assessed for microscopical changes, total motility, progressive motility, vitality, level of oxidative stress (OS) were detected in all fractions 30 minutes later after addition of the antioxidants.

Eligibility Criteria:
Inclusion Criteria:

* must have been married for 1 year before inclusion into the study and were unable to achieve pregnancy
* must have not received an antibiotic treatment for the last 4 weeks prior to sampling
* showed oxidative stress- mediated asthenozoospermia in their semen

Exclusion Criteria:

* Severe male Factor
Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee pain.


Eligibility Criteria:
Inclusion Criteria:

* History of pain due to medial osteoarthritis
* Qualifying baseline pain scores
* Kellgren-Lawrence Grades 2-3

Exclusion Criteria:

* Osteoporosis
* Rheumatoid arthritis
* Joint instability
* Metal ion allergy
* Permanent implant in or around the knee joint
* Prior anterior cruciate ligament reconstruction