cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)

The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase

Inhibitor (SCH 66336) when given in combination with Gemcitabine and Cisplatin in patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced cancer for which there is no treatment available which would have a reasonable chance of disease palliation or cure
* Age greater than or equal to 18.
* SWOG performance Status less than or equal to 2.
* Meets protocol requirements for specified laboratory values.
* Written informed consent and cooperation of patient.

Exclusion Criteria:

* Prior treatment with an FPTI
* Knowledge of intracranial metastases or carcinomatous meningitis.
* Poor medical risks because of nonmalignant systemic disease or uncontrolled active infection.
* Medical conditions that would interfere with taking oral medications.
* Significant uncontrolled diarrhea.
* Chemotherapy, radiotherapy or major surgery within 4 weeks; full recovery from prior treatment.
* Concomitant use of CYP3A inhibitors/inducers per protocol.
* Known HIV positivity or AIDS-related illness.
* Pregnant or nursing women.
* Men or women of childbearing potential who are not using an effective method of contraception.
* Concurrent chemotherapy, hormonal therapy, radiotherapy or immunotherapy.
* QTc prolongation (\>440 msecs) at baseline.
* Patients with previous high-dose therapy requiring stem cell rescue or bone marrow transplant, or irradiation to \>30% of bone marrow-containing areas.
* Patients that have received Mitomycin-C or nitrosoureas.
Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate.

In addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments...i.e., "the right treatment for the right patient for right duration."


Eligibility Criteria:
Inclusion Criteria:

* women with a diagnosis of osteopenia or osteoporosis as defined by Bone Mineral density (BMD)
* patient treated with BPs for \>5 years
* patients treated with non-BP anti-fracture medications such as...
* estrogens, raloxifene, calcitonin
* treatment naive patients

Exclusion Criteria:

* all men regardless of BMD result
* patients with obvious traumatic AFF
* patients with normal BMD (better than -1.0 T-score at spine or proximal hip)
* unable to take tetracycline
* previous use of teriparatide
* known allergies to the following:
* tetracycline antibiotics
* meperidine
* midazolam
Psychobiological Effects of Meditation on Offenders With Psychopathy

The investigators aim to explore the psychobiological effects of a 5-day meditation intervention on offenders within dangerous and severe personality disorders (DSPD) unit at HMP Whitemoor. DSPD unit accommodates offenders with psychopathy or with two or more personality disorders. DPSD unit provides them with a 5-year rehabilitation programme that consists of group and individual therapy and aims to improve their self-regulation.

This project includes a total of 60 participants and has two major methodological innovations. First, it will include yoga as an active control group that will be matched to the meditation intervention (which means it will have the same length and the same social components) and a passive control group that will be following their usual regimen. Thus, the effects of meditation will be contrasted with another type of intervention and with not receiving any intervention.

The second methodological innovation is the combination of psychological and biological measures. Psychological measures include questionnaires (emotion regulation, mindfulness, stress) and cognitive measures (attention,empathy,behavioural control). Biological measures include EEG to measure brain activity related to empathy; gene expression and protein interlukin-6 to measure changes in immune system; and stress related hormone cortisol. The investigators also aim to determine to whom does meditation benefit the most by exploring how initial expectations of meditation, personality, mood and previous life adversity predict outcomes of meditation or yoga. The data will be collected at three time points: at baseline, immediately after and 10 weeks after the 5-day intervention.

The investigators expect that meditation and yoga will similarly improve mental and physical health. If this hypothesis are confirmed, these results will extend previous findings on the benefits of meditation and yoga to vulnerable populations, and would provide a cost-effective addition to prisoner rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Male offenders with dangerous and severe personality disorder aged 18-65 who will remain in the prison until at least February 2017.

Exclusion Criteria:

* Major psychiatric or neurological disorders, previous meditation or yoga experience, unable to follow instructions in English,
Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer

To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.

Olanzapine and Mirtazapine have been used in the past few years to attempt to prevent weight and appetite loss in cancer patients. Both have mixed study results and none of the previous studies are of high enough quality to make clinical recommendations. With limited options available, palliative and oncology providers turn to these medications with little evidence. There are no formal studies comparing the two to determine if one is superior to the other, so choices are often made based purely on provider preference. We aim to conduct a study to determine if one of the drugs outperforms the other to guide our standard practice at Englewood Health. This study is being conducted to determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* • 18 years of age or older

  * Able to provide informed consent
  * Pathologically and/or clinically confirmed diagnosis of advanced cancer
  * At any point of treatment with standard chemotherapy\*

    o Scheduled to start, have discontinued or completed, or currently receiving
  * Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation

    o Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2-week period).
  * Life expectancy of at least 4 months
  * Able to communicate well and comply with study requirements, including by phone and written logs

    * Patients on Dexamethasone will be allowed

Exclusion Criteria:

* • Abnormal liver function defined as \> twice upper limit of normal

  * Elevated QTc

    o EKG performed within 1 year of enrollment will be accepted
  * Total parental nutrition (TPN) or enteral feeds (PEG/PEJ) for \>70% of their primary source of daily calorie intake
  * Taking Marinol within 2 week of enrollment onto study
Human Papillomavirus in Menstrual Blood

The investigators tried to know whether a virus causing cervical cancer could be detected in menstrual blood and to set up a experimental setting to detect the virus.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women with HSIL at Pap test or high-risk HPV

Exclusion Criteria:

* Suspicious cancer
Atrial Fibrillation Registry in Jordan

Prospective registry of all new comers with Atrial fibrillation

12 tertiary care centers will enroll all AF comers. Details of baseline clinical, EKG, echo, and lab data will be documented for all patients. Management is according to the physicians discretion. Patients will be followed up for 1 year for clinical endpoints including cardiovascular death, stroke, heart failure, systemic embolization and bleeding.. Anticoagulants and other cardiovascular medications will also be documented.

Eligibility Criteria:
Inclusion Criteria:

* Admission with atrial fibrillation
* developing atrial fibrillation during hospitalization for mon AF reason.
* age 18 or more years.
* patients welling to participate in the registry.

Exclusion Criteria:

* age less than 18 years.
* patients not welling to participate.
Peer Outreach and Navigation Intervention to Increase PrEP Uptake Among Women at High Risk for HIV

This pilot study will assess the feasibility and acceptability of a peer outreach and navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis (PrEP) uptake among women at high risk for HIV.

Women who engage in exchange sex (i.e., sex in exchange for money, drugs, or other services) remain are at substantial risk for HIV infection. (1-6) Due to a confluence of social and structural factors, exchange sex is relatively prevalent among women from socially and economically marginalized groups, such as women who are transgender, unstably housed/homeless and/or those who use and/or inject drugs. (1-3, 19-23) The overarching goal of this research is to decrease new HIV infections among women who engage in exchange sex. Daily oral HIV pre-exposure prophylaxis (PrEP) is an innovative method of HIV prevention that women, themselves, can control; as such, PrEP has the potential to reduce the risk of HIV acquisition among women who engage in exchange sex. Therefore, the investigators developed a theory-guided behavioral intervention (PrEP-UP) which utilizes street-based peer outreach and navigation to increase access to PrEP and promote PrEP uptake among women involved in exchange sex. Specifically, PrEP-UP involves a Peer delivering PrEP education and counseling during street-based outreach followed by offer of a PrEP care appointment along with peer navigation (e.g., appointment accompaniment and reminders, etc.) for the first several PrEP care visits. The objective of this study is to assess the feasibility and acceptability of PrEP-UP. To implement PrEP-UP, the investigators will collaborate with an established community-based organization (CBO) in East Harlem, NY, which uses street-based peer outreach and navigation to connect individuals to needed health and social services. Medical and pharmacy records will be reviewed to assess PrEP initiation. The investigators will conduct self-report surveys at baseline and at a week 4-12 follow-up visit that will collect data about sexual and drug use risk behaviors, perceived HIV risk, and PrEP-related knowledge, attitudes, and self-efficacy to assess for temporal changes in these variables. Additionally, individual interviews will be conducted post-intervention with a subset of the women as well as the CBO staff and leadership to access acceptability of the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old
2. fluent in English
3. self-identifies as female or male-to-female transgender (or on the spectrum)

Exclusion Criteria

1) Incapable of providing informed consent (i.e., acutely intoxication, active psychosis, etc.)
Role of Ipsilateral Motor Cortex in Executing Movements With Increasing Demand on Precision

It is well known that the motor area of one hemisphere of the brain (motor cortex) controls the movement of the opposite of the body. However, it is not clear whether as the movement becomes more complicated, the motor cortex of both hemispheres of the brain are involved. Currently the role of the motor cortex on the same side of the body (referred to as ipsilateral motor cortex) in hand performance remains controversial. The investigators demonstrated previously in healthy subjects that transiently lowering the activity of ipsilateral motor cortex improved the performance of the opposite hand. What is not know are the mechanisms involved in these changes of behavior. Transcranial magnetic stimulation (TMS) is a device that allows the non- invasive stimulation of the brain. When brain is stimulated repetitively at a very low rate and low intensity for about 15 minutes, the stimulated brain area becomes less active. This effect lasts 10 minutes and is called a "transient artificial lesion" as it mimicks the effects of transiently interfering with the function of the stimulated brain area. In the present study the investigators will conduct experiments using repetitive TMS to downregulate the activity of the motor area as in previous experiments and measures its effect on activity of motor cortex of both hemispheres. The investigators will study healthy subjects. It would be important to understand the effects in more detail for the design of treatment strategies in patients after stroke, which will be a topic of future studies.


Eligibility Criteria:
Inclusion Criteria for Stroke Patients:

* Age 18-80
* Single cerebral ischemic infarction one month prior to entering study
* Affecting only one hemisphere as defined by MRI of the brain
* At the time of cerebral infarct a motor deficit of hand of Medical Research Council Scale for Muscle Strength (MRC) of \< 4- of wrist and finger extension/flexion movement
* Fugl Meyer score \> 27/66 (motor domain, upper extremity)
* Ability to operate joystick at largest target level
* No other neurological disorder
* No intake of Central Nervous System (CNS) active drugs
* Ability to give informed consent
* Ability to meet criteria of inclusion experiment
* No major cognitive impairment

Inclusion Criteria for Healthy Subjects:

* Age 55-80 years with no neurological or psychiatric diseases
* Normal neurological examination
* Normal MRI of the brain
* Normal neuropsychological testing
* No intake of CNS active drugs that interfere with data collection
* No contraindication to TMS
* Ability to give informed consent
Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.

Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study.
* Women of childbearing potential must have a negative serum pregnancy test result at study start.

Exclusion criteria:

* Presence of any new/and or clinically important medical condition that might compromise patient's safety.
* Use of prohibited treatment.
* Meets any of the exclusion criteria listed for study 3151A4-327.
Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers

To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target spherical equivalencies).


Eligibility Criteria:
Inclusion Criteria:

* Age: 50-85 years old
* Clinically Significant Cataracts that interfere with daily activities
* Patient is able to understand and able to consent to informed consent
* Patient is able to come to all postoperative visits and agrees to follow up at 30 days -2/+14 days
* Patient undergoing cataract surgery, with implantation of the Alcon SN60WF lens in the capsular bag.

Exclusion Criteria:

* Axial Length \< 22.00 and \> 26.00
* Corneal Astigmatism \> +1.00 Diopters
* CCTS: \< 490 and \> 600
* Prior Refractive Surgery: RK, PRK, LASIK, INTACTS
* History of contact lens use: Soft lenses within 2 months of surgery, RGP within 60 months of surgery
* Corneal Disease: Keratoconus, Corneal Dystrophies, Any prior corneal Surgery, Prior infections
* Retinal Disease: Macular Pathology, CSCR, CME, Macular Degeneration, Drusen, Retinal Detachment, TPPV, SB, prior IVT, Prior PRP or Focal Laser, Diabetic Retinopathy
* History of Uveitis
* POAG: Undergoing any concomitant MIGS procedure- iStent, Omni, iTrack, Hydrus, etc
* Enrollment in any prior clinical trial within 2 years
* Systemic Disease that in the investigator's opinion may affect outcome
* Currently Pregnant or Breastfeeding
* Severe Dry Eye
* Tear Osmolarity \> 320mOsms/L (Moderate)
* Any Surgical Complication(s)
* IOL implanted outside of the capsular bag /capsular damage /weakness /CTR placement
Use of a Robot in Medication Management for Older People's Home Care

Non-randomized controlled clinical trial was used. Data were collected using the Working Time Tracking Form in three data collection points (baseline, at 1 month and at 2 month). The participants were home care professionals who carried out home care clients' medication management. Home care clients were allocated into intervention and control groups (n=64 and 46, respectively) based on whether or not they used the robot. The statistical analysis methods were used.

The data were collected using a Working Time Tracking Form, which was developed by professional team for this study. The team included senior lecturer in nursing with medication management competence, head of older people's home care, and home care professional working in older people's home care. The content of the Time Tracking Form was founded on previous literature about the medication management process in home care. The research protocol was planned by the authors before the study and it can be accessed from the corresponding authors on a reasonable request. The home care professionals filled in the Working Time Tracking Form the time in minutes they used for each phase of process i.e. ordering medications, dispensing medications to the doset or dispensing medications to the robot, reconstitution medications, administration of medications in tablets, administration of medications in other routes, medication education, and monitoring the effects of medications. The Working Time Tracking Form was filled in from each client and from each home visit, which included medication management for a five-day period in baseline and in follow up after one and two months.

The expert panel evaluated, and pilot group pre-tested the Time Tracking Form's content validity. The expert panel consisted of seven participants: one head of home care, three home care professionals, and two senior lecturers in nursing with medication management competence, and one statistician. Panel members evaluated each item focusing on usability, but they did not find revision. A pre-test (answers were not included in this study) was performed with 10 home care professionals having the experience using the robot for medication management in older people's home care. This helped evaluate how understandable and clear the Time Tracking Form's content was and how long time it took to be completed.

The SPSS v.26 software was used to analyse data.The characteristics of sample were reported using descriptive statistics including frequencies, percentages, medians, mean values, and standard deviation.

Eligibility Criteria:
Inclusion Criteria:

* voluntariness,
* working presently in older people's home care and
* communication in Finnish or English

Exclusion Criteria:

-
Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting

The purpose of this study is to access the effect of TEAS of P6 in the prevention of PONV in women scheduled for gynecologic laparoscopic surgery with general anesthesia.

150 female patients, aged between 18 to 60 y, who are scheduled for elective gynecological laparoscopic surgery requiring general anesthesia, will be randomly allocated by a computer generated randomization table to acustimulation group (Group Acu), tropisetron group (Group Trp),or dexamethasone group (Group Dxm).

In Group Acu, a surface electrode will be applied in the induction room to the P6 acupoint 30 min before induction.An operator will set electric stimulating current at 1mA with frequency at 2 Hz, and gradually increased the current intensity to a little below discomfort threshold.The stimulation will be maintained until the patient is discharged from the post-anesthesia care unit (PACU). In Group Trp and Group Dxm, the same protocol will be applied unless silicone covers attached to both electrodes.

A standardized anesthetic protocol will be followed. After induction, dexamethasone 10mg i.v. will be given in all groups. All patients will receive intravenous lactated Ringer's solution based on calculated preoperative deficits, surgical procedure, and estimated intraoperative blood loss. Parecoxib 40mg i.v. during surgery and incision infiltration of 0.5% ropivacaine at the end of surgery will be used for post-operative analgesia. After surgery, analgetic therapy will continue with morphine upon patient's request.After extubation, patients will be transported to PACU and observed for no less than 30 min. Metoclopramide 10mg i.v. will be administered as a rescue therapy to any patient who experiences an episode of moderate or severe nausea, an episode of vomiting, and requests rescue medication.

At the start of skin closure, a prefilled syringe which contains 5 ml of a solution will be administered intravenously to the patient. It will contain either saline (Group Acu and Group Dxm) or tropisetron 5mg (Group Trp).The syringe with the drug will be prepared by a study coordinator according to group allocation.

The patients, the anesthesiologists, and the nursing staff shall be unaware of the group assignments.

An anesthesiologist and an anesthetic nurse, who are trained for the study and blinded to the randomization, will collect the data.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II
* aged between 18 to 60yr
* scheduled for elective gynecological laparoscopic surgery requiring general anesthesia

Exclusion Criteria:

* pregnancy or breastfeeding
* mental retardation
* psychiatric or neurological disease
* use of antiemetics, emetogenic drugs, opioids or glucocorticosteroids within 3 days prior to surgery
* known allergy to tropisetron or dexamethasone
* nausea and/or vomiting within 24 hr prior to surgery
* implantation of a cardiac pacemaker, cardioverter, or defibrillator
* any skin problem at the acupoint stimulation area