cyrilzakka/clinical-trials huggingface dataset:
Communication Effectiveness in Cancer Treatment

This pilot research trial studies communication effectiveness in cancer treatment. Studying how well patients and their doctors communicate about the treatment being given for cancer may help improve the decisions that patients and physicians make together.

PRIMARY OBJECTIVES:

I. To assess the feasibility of measuring discrepancies between patient and physician perceptions about the intent of therapy.

SECONDARY OBJECTIVES:

I. To explore possible correlation between various patient satisfaction indicators and discrepant patient perceptions about their care.

II. To gather exploratory data on patient characteristics that might correlate with discrepant patient perceptions about their care.

OUTLINE:

Patients complete questionnaires, including the Functional Assessment of Cancer Therapy-Treatment Satisfaction (FACIT-TS-G), the Functional Assessment of Cancer Therapy-Spiritual Well Being (FACIT-Sp12), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the Distress Thermometer (DT). Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary.

After completion of study, patients are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of cancer
* Patients must have been in active therapy for cancer for at least one month or have a scheduled surgical treatment of their cancer
* Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document
An Extension of Protocol PRO 140_CD01 TS Study

This study is a Phase 2b, multi-center, extension study designed to evaluate the long-term efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who were stable on combination antiretroviral therapy and completed 12 weeks of treatment under PRO140_CD01 Treatment Substitution Study without experiencing virologic failure.

Consenting patients will continue to receive PRO 140 monotherapy for 160 additional weeks. Total treatment duration with PRO 140 will be up to 161 weeks with one week overlap of existing retroviral regimen and PRO 140 at the end of the treatment extension phase in subjects who do not experience virologic failure.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have completed 12 weeks of treatment in PRO 140_CD01 study without experiencing virologic failure.
2. Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative urine pregnancy test prior to receiving the first dose of study drug.
3. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria:

1. Not currently enrolled in PRO140_CD01 Treatment Substitution Study
2. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
3. Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
4. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
5. Unexplained temperature \>38.5C (101.3F) for seven consecutive days within 14 days prior to the first study dose
6. Diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) that in the opinion of the primary care provider and/or site investigator would interfere with the subject's successful completion of the study requirements
7. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Investigation of Oxidative Markers and Antioxidant Defense in Female Patients With Osteoarthritis

Osteoarthritis has a multifactorial etiology: aging, genetic, sex, weight, alimentation, injuries, infections etc. The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). Also, the oxidative-antioxidative balance will be evaluated by determining markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde.

A total of 300 patients with osteoarthritis will be included in the study. The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). Also, the weight and height of each patient will be assessed and the patients will be included in 4 classes based on the body mass index: underweight, normal weight, overweight and obese. The type of physical activity will also be noted and the oxidative-antioxidative balance will be evaluated by determining serum markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde. Correlation between eating behaviour, body mass index and oxidative stress markers will be made.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis
* signed informed consent

Exclusion Criteria:

* drugs or foods with antioxidant effects
* lack of judgement
* refuse to participate
Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. Male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will be a wash-out period of at least 5 days between doses.


Eligibility Criteria:
Inclusion criteria:

* Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
* screening pre-bronchodilator FEV1 \>or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of \>or= 12.0% over the max of the three screening measures and an absolute change of

  \>or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria),
* BMI 19-31 kg/m2,
* Non-smoker,
* refrains from use of prohibited medication within the specified timeframes

Exclusion criteria:

* Pregnant or nursing females
* History of life threatening asthma
* Subjects who are unable to stop taking protocol defined prohibited medication
Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population

The objective of the study is to determine the effects of transcutaneous auricular vagus nerve stimulation on dizziness and balance on elderly population with unilateral vestibular hypofunction. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. Intervention Group A received Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey exercise while Group group B received Caw Thorne Cooksey exercise only. Both groups received intervention of 30 minutes daily for 4 weeks (16 sessions). Assessment was done at the baseline, after 2 weeks and after 4 weeks

Vestibular hypofunction is also known as vestibulopathy or vestibular dysfunction. It may be unilateral affecting one side or a bilateral vestibulopathy having symptoms on both sides.Typically, vestibular dysfunction results in incapacitating symptoms including imbalance, dizziness, and/or oscillopsia. Symptoms of postural instability and unsteadiness of gait, which aggravate in low light and on uneven terrain, may be given by the patient. The symptoms of the patient may go away while they are sitting or lying still. Without any obvious symptoms, it may be quiet Vestibular hypofunction is a common condition among the elderly population and is associated with a high risk of falls and other balance-related problems. Dizziness and balance problems can significantly impact the quality of life of elderly individuals, leading to a loss of independence and increased risk of injury. Cawthorne Cooksey exercise is a well-established and effective rehabilitation program for individuals with vestibular hypofunction. Transcutaneous auricular vagus nerve stimulation has also been shown to have promising effects on balance and dizziness. However, the combined effect of these two interventions has not been extensively studied.

Eligibility Criteria:
Inclusion Criteria:

1. Able to give consent
2. Age 60 and above
3. Diagnosed patient of unilateral(Left) vestibular hypo function
4. Both Genders
5. BBS with 20-41

Exclusion Criteria:

1. Patient with any neurological impairment (Epilepsy, stroke ALS etc.)
2. Central cause of vestibular hypo function
3. History of vestibular neuritis, concussion, head injury or tumor.
Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)

Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system.

Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran populations.

This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either a 14-day course of propranolol or placebo. This study will then follow these Veterans for a one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes.

The investigators hypothesize that patients with PTSD randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects scheduled for any surgical procedure under general anesthesia or combined general-regional anesthesia, with the exception of open-heart or intracranial surgery. Regional anesthesia includes: 1) Epidural anesthesia, 2) Sub-arachnoid block (spinal), or 3)any regional nerve block
2. Anticipated postoperative hospital admission (defined as at least one overnight hospital stay)

Exclusion Criteria:

Veterans will be excluded if:

1. They are on beta blocker therapy at the time of the preoperative baseline assessment
2. They report sensitivity or allergies to propranolol, or a history of PTSD exacerbation with prior propranolol therapy
3. Veterans who fulfill the AHA/ACC level I recommendation criteria for perioperative beta blocker therapy (e.g., metoprolol, atenolol) and should not be randomized to placebo group
4. Medical exclusions criteria: high grade heart block without pacemaker (all patients with 2nd and 3rd degree heart block), marked resting bradycardia (heart rate ≤ 55 beats per minute), blood pressure \< 100 mmHg, uncompensated congested heart failure, severe hyperactive airway disease, and Raynaud's disease
5. Pregnancy
6. Current use of medication that may involve potentially dangerous interaction with propranolol
7. Circumstances that, in the opinion of the principal investigator, would preclude participation in a study of this type (e.g. medical concerns or difficulty in long-term followup).
8. Open-heart surgery and intracranial surgery
Study of PIVKA-II and AFP Measurement in Surveillance Program for Early Detection of Hepatocellular Carcinoma

There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early stages of HCC than the 6 month interval of AFP that is commonly used

There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early stages of HCC than the 6 month interval of AFP that is commonly used

Eligibility Criteria:
Inclusion Criteria:

* LC

Exclusion Criteria:

* previous HCC
Identification of the Impact of Acute Pancreatitis on Quality of Life

In abdomen, the pancreas as a gland is involved in the digestive and endocrine system by secreting digestive enzymes and insulin. Acute pancreatitis (AP) is a common inflammatory condition of the pancreas with symptoms of sudden abdominal pain and high temperature which may develop to severe complications in some patients. The incidence of AP was roughly 33.74 cases per 100, 000 person-years around the world but varies in different regions which America has the highest incidence of 58.20 cases per 100 000 person-years. There are very few studies published on AP in China, while Japanese national survey in 2011 estimated an incidence rate of 49.4 per 100,000 population and a study in Taiwan showed an annual average incidence of 36.9 per 100,000 persons with a slight change over ten years.

In most cases, patient with AP will start to recover within a week, but the patient quality of life (QoL) is still a big concern for disease management. It quantitatively measures the physical, mental and social wellbeing of individuals or their life satisfaction by questionnaires or surveys. Although very few studies have demonstrated the effect of AP on patient QoL, there is accumulating evidence to show its importance. Some studies reported no differences in QoL between AP patients and age-matched healthy people, whereas others showed QoL was significantly impaired due to AP. A large population-based follow-up study is needed to evaluate the impact of acute pancreatitis on quality of life. In addition, as the population investigated in most research was European based, the QoL evaluation of patients after AP among the Chinese population is also essential.


Eligibility Criteria:
Inclusion Criteria:

* Acute pancreatitis.
* Must be able to response an online survey.

Exclusion Criteria:

• N/A
A Phase I Study of CDX-622

This is a study to determine the safety of CDX-622 in healthy participants.

CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP).

This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in healthy participants.

Eligibility Criteria:
Key Inclusion Criteria:

* An informed consent signed and dated by the participant.
* Healthy volunteer aged 18-55.
* In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
* Body mass index (BMI) ≥ 18 kg/m2 to ≤ 32 kg/m2.
* No course of medication, whether prescribed or over the counter, in the 4 weeks before study drug administration.
* Both males and females of childbearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
* Not a current smoker (or regular user of any nicotine containing product).
* Willing to follow all study rules.

Key Exclusion Criteria:

* Women who are pregnant or nursing.
* History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication.
* History of asthma requiring the use of inhaled medication within the past 5 years.
* Vaccination within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
* Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
* Positive urine test for alcohol and drugs of abuse.

Additional protocol defined inclusion and exclusion criteria could apply.
A Pilot Study Of Riluzole In Patients With Post Traumatic Stress Disorder (PTSD)

This open label study will evaluate the safety and efficacy of riluzole in patients with PTSD. Patients will receive riluzole 50mg twice per day orally for 12 weeks as outpatient, with a one month follow up at week 16.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between the ages of 18-75 years;
* Able to provide written informed consent;
* Current Post Traumatic Stress Disorder, as determined by the Clinician Administered Scale for PTSD, or the presence of sub-threshold PTSD. Individuals with sub-threshold PTSD will be included at the discretion of the PI;
* Clinician Administered PTSD Scale (CAPS) score of 23 or higher;
* Be able to understand and speak English.
* Subjects taking FDA-approved antidepressant medications may enter the study if they have been on a stable dose for at least 4 weeks prior to starting the study drug.

Exclusion Criteria:

* Breastfeeding women and pregnant women, or women of child bearing potential who are not using a medically accepted means of contraception (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy);
* Current, ongoing serious suicidal risk as assessed by evaluating investigator or by scoring 5 or more on the item-10 of the MADRS.
* Unstable medical illness as determined by the investigator;
* Patients with schizophrenia or schizoaffective disorders (current or past);
* Substance use disorder during the 3 months prior to screening; except for Cannabis and Alcohol use Disorders.
* Clinical evidence of untreated hypothyroidism;
* Patients with any evidence of clinically significant liver abnormalities, or any liver transaminase level \> 1.5 x ULN at initial screening, or \> 5 x ULN during treatment;
* Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patient's safety or compliance, as determined by the investigator during open-ended psychiatric interview;
* Patients currently being treated for a respiratory disorder (including asthma or COPD);
* For participants over the age of 60, evidence of dementia as determined by the St. Luis University Mental Status Exam (SLUMS; participants with total scores less than or equal to 20 will be excluded and referred to their Primary Care Physician for follow-up/dementia evaluation); Structured psychotherapy focused on treatment of PTSD is exclusionary unless the subject has had at least 8 weeks of treatment prior to starting the study medication;
Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery

Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome. In this study, the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated.

Chronic kidney disease (CKD) affects the structure and function of the kidneys. Many of CKD patients are not suitable candidates for a kidney transplant, so relying on some type of dyalisis is unavoidable.

Hemodialysis is the most common type of Renal Replacement Therapy. The best vascular access for hemodialysis in patients with chronic renal failure is Arterio-venous fistula (AVF). One of the complications of arterio-venous fistula is Steal syndrome which is ischemia of the limb secondary to blood flow diversion from the arterial system to the venous system through AVF.

Non-invasive wrist blood pressure measurement before and after the fistula construction may accurately assess the risk of ischemia and Steal syndrome from a functional AVF. Wrist-brachial index as a reliable prognostic test could be done easily in time of fistula construction and if it is normal, it assures the surgeon that the distal circulation is sufficient.

Summary of the project implementation method: First, the demographic questionnaire is completed for patients who meet the criteria for entering the study. Then the wrist-brachial index of patients who are candidates for fistula implantation before and after the fistula implantation is measured. Two weeks and three months later (times of suture removal and fistula maturation assessment), the measurements are repeated and their correlations with steal syndrome symptoms are recorded.

The data will be analyzed in SPSS16 statistical software

Eligibility Criteria:
Inclusion Criteria:

* ESRD patient candidate for hemodialysis
* Eligible for AVF implantation
* Cardiac Ejection Fraction \> 20%
* Age\> 18 years
* Suitable brachial artery and superficial vein for AVF

Exclusion Criteria:

* Death
* Non-consent of the patient
* Failure to follow up
* Fistula failure