cyrilzakka/clinical-trials huggingface dataset:
Level of Physical Activity and Its Associations With Fatigue and Quality of Life in Multiple Myeloma Survivors

The purpose of this study is to gives understanding to level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting. As multiple myeloma survival improves, it is vital to focus on interventions that will help to maximize QOL. A positive correlation may suggest that exercise is such an intervention.

The hypothesis are multiple myeloma survivors are performing low levels of physical activity. Higher levels of physical activity will be associated with higher levels of QOL and lower fatigue levels.

Multiple myeloma its associated treatment often result in persistent symptoms such as fatigue, pain, neuropathy and diminished functional performance that can affect the survivor's quality of life (QOL). And as survival for multiple myeloma continues to improve, physical activity may be a supportive therapy that can help to address the multitude of QOL concerns. Physical activity is a modifiable behavior, and has been proposed as an important non-pharmacologic intervention to improve health-related outcomes among cancer survivors. The American College of Sports Medicine examined evidence of the impact of physical activity in cancer survivors, and concluded that physical activity is safe for cancer patients, both during and after cancer treatment, and may lead to improved physical functioning, decreased physical fatigue, and improved QOL in a number of cancer survivor groups, including hematopoietic malignancies. While a small number of studies have suggested that exercise may reap benefits in QOL and fatigue in multiple myeloma survivors, none were conducted in the local context.Given the limited evidence, the primary objectives of this preliminary study is to estimate the prevalence of physical activity among a local sample of multiple myeloma survivors, and to investigate its associations with reported fatigue and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Myeloma
* Able to complete questionnaires

Exclusion Criteria:

- Unable to complete questionnaires
Usefulness of the Chronic Obstructive Pulmonary Disease-population (COPD-PS) Questionnaire and the COPD-6 Device in the Chronic Obstructive Pulmonary Disease Detection in a Tobacco Detoxication Consultation

The aim of this study is to evaluate the usefulness of the chronic obstructive pulmonary disease-population questionnaire (COPD-PS) and the COPD-6 device in the early detection of chronic obstructive pulmonary disease in smoker patients .


Eligibility Criteria:
Inclusion Criteria:

* \> 35 years old
* Accumulative tobacco rate \> 10 paq-year that go to the tobacco detoxication consultation

Exclusion Criteria:

* Unable to fulfill the questionnarie
* Unable to adequately perform the COPD-6 or forced spirometry maneuvers included in the study.
* Reject to participate and sign the informed consent.
Carotid Risk Prediction (CRISP) Consortium

Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.

Develop adverse event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as information on events and interventions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have two (or more) neck CTAs at least 6 months apart of sufficient quality as documented in the vascuCAP Reading Manual.
* Atherosclerotic plaque must be visualized within the carotid artery.

Exclusion Criteria:

* Subjects without visible plaque within the carotid artery
* Subject with insufficient CTA image quality (defined strictly as documented in the vascuCAP Reading Manual)
Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement

The purpose of this study is to examine three different ways to control pain after hip replacement:

1. One time injection of ropivacaine before wound closure
2. One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours
3. Standard practice of patient controlled pump


Eligibility Criteria:
Inclusion Criteria:

* total knee replacement

Exclusion Criteria:

* History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.
* Born after a gestation period of 36 to 42 weeks inclusive.
* Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

• Current febrile illness or axillary temperature \>= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration
The Expression of TLR2 and TLR4 in the Lung of Chronic Obstructive Pulmonary Disease (COPD) Patients

Smoking is the most important risk factor of COPD, but only a fourth of smokers had COPD in their life. There are also healthy smokers without evidence of COPD. Investigators hypothesize that innate immunity may affect this difference between COPD patients and healthy smokers, because TLR4 is the receptor of LPS, which is the one of important substance in cigarette. Investigators will measure TLR2 and TLR4 expression in lung tissue of patients whose lung will be resected. Investigators will compare the level of expression between COPD patients and healthy smokers.


Eligibility Criteria:
Inclusion Criteria:

* All patients who will have lung resection for the therapeutic cause.

Exclusion Criteria:

* Patients who do not agree with our study protocol
Comparative Effectiveness of MR Enterography

The purpose of this study is to determine the efficacy of ultrasound imaging compared to MRE (Magnetic Resonance Enterography) a form of magnetic resonance imaging (MRI) in accurately diagnosing and following Small Bowel Crohn Disease (SBCD) in children.

Computed Tomography (CT) is an imaging tool that exposes patients to radiation, and until recently it was the most commonly used imaging method to evaluate small bowel Crohn disease. Recently, Magnetic Resonance Enterography (MRE) which is a form of magnetic resonance imaging that provides detailed images of the bowel and less frequently, Ultrasound (US) are replacing CT as the standard of care imaging tool at some institutions.

The investigators would like to determine how effective US imaging is compared to MRI imaging in accurately diagnosing and following SBCD in children. Along with enteric ultrasound (EnUS) we will also be comparing a new ultrasound technology called Ultrasound Elastography Imaging (UEI) for this study in which we will be using a second form of UEI called Acoustic Radiation Force Impulse (ARFI). This technique uses sound waves to asses the stiffness properties of soft tissue. The study will compare costs, patient preferences, and imaging accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients under 18 years age.
* Recently diagnosed with small bowel crohn's disease and have not received any prior treatment for this condition

Exclusion Criteria:

* Are pregnant.
* Require sedation to have the MRE exam.
* Cannot tolerate small enclosed spaces for 60 minutes.
* Have kidneys that are poorly functioning (eGFR \<30ml/min)
Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B

This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.

A total of 463 HBeAg-positive patients were recruited from 33 hospitals in China, and randomized to two groups. The combination group received PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks. The control group received placebo and adefovir. The primary endpoint was the loss of HBeAg at 48 weeks. The secondary endpoints included 1) loss of hepatitis B virus (HBV) DNA, 2) HBeAg seroconversion and 3) alanine aminotransferase (ALT) normalization etc. at week 4, 12, 24, 36 and 48. The number of CD4＋and CD8＋T cells was also determined during 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B for more than 6 months, and didn't accept immunomodulating or anti-viral treatment within 6 months before the trial.
* ALT level \> 2 × Upper Limit Normal (ULN).
* Serum bilirubin \< 2 × ULN.
* Positive HBeAg and negative HBeAb.
* HBV-DNA between 1.00E＋05 IU/ml and 9.99E＋09 IU/ml.
* Informed Consent Form (ICF) signed.

Exclusion Criteria:

* Hepatitis A,C,D,E or HIV infection.
* Autoimmune hepatitis.
* Hepatic cirrhosis.
* Serum creatinine \>1.5 × ULN or Ccr \<50 ml/min, Haemoglobin \<110g/L (male) or \<100g/L (female), Platelet\<80 E＋09/L, Serum albumin ≤ 35g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte \<1.0 E＋09/L, Prothrombin time\>ULN＋3 seconds, Cholinesterase\<4000U/L.
* Hepatitic carcinoma or Alpha Fetal Protein (AFP) \>100ng/ml .
* Patients with other severe diseases combined, which could affect the therapy.
* Patients accepted other clinical trial within 6 months before the first administrated.
* Thymosin allergy.
* Pregnant or breast feeding.
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly)


Eligibility Criteria:
Inclusion Criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
2. Men and women aged \>= 18 and \<= 60 years or \>= 61 years of age at the day of study vaccination.
3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator

Exclusion Criteria

1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
2. A serious adverse reaction after a previous (influenza) vaccination.
3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
5. A history of Guillain-Barré syndrome or active neurological disease
Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass

Background: As the aging of the population aggravating, the ratio of the elderly in empty nest family has reached 50%, particularly in big and medium size cities, it is as high as 70%. The elderly in those families where no child living inside, elderly living alone, including an individual living alone or living with spouse are known as empty nester. The diversity of food consumption of empty nester is always poor, with single and simple meals, especially for the consumption of "core food" (fish, meat, egg, milk, vegetables and fruits), and the quantity and variety of consumption is very limited, which make the elderly be prone to be deficient of high quality protein and micronutrient. In 2005, the World Health Organization (WHO) brought up a new concept for the universally exiting problem of vitamin and trace elements intake deficiency among people, namely Hidden Hunger. With age increasing, multiple causes such as single eating pattern, empty nest lifestyle and chronic diseases lead to long term intake deficiency of protein and micronutrient of the elderly, which will further result in various symptoms of nutritional deficiency. Therefore, it is particularly important for the empty nester to have sufficient energy, high quality protein and multiple micronutrients to prevent hidden hunger and sarcopenia, thus avoiding the health problem and life quality decreasing caused by them.


Eligibility Criteria:
Inclusion Criteria:

1. the one who is or is between 65 to 85 years old, male or female;
2. the one with nutritional risk according to MNA-Short Form evaluation (score less than12);
3. the one who has low skeletal muscle mass (with bioelectrical impedance analysis report indicating that the skeletal muscle mass is less than 90% of the normal level) and/or the one who has at least 1 type of the micronutrient deficiency symptom (part A \< 40 or part A \< 85 in the hidden hungry evaluation questionnaire)

Exclusion Criteria:

1. long-term bedridden or the one has difficult in taking food orally;
2. Liver failure in recent one year;
3. Renal insufficiency (serum creatinine is more than 2 times of normal value)
4. the one who is allergic to or not applicable to the component in oral dietary supplement;
5. the one with parkinsonism, epilepsy and other nervous system disorders;
6. malignant tumor patients with chemotherapy and chemotherapy;
7. irritable bowel disease and other chronic wasting diseases.
8. Taking multi-vitamin\&mineral supplements or protein or other oral nutritional supplements
OD-doxy-PNV-COVID-19 Old Drug " DOXY " for Prevention of New Virus " COVID-19 "

Given the urgency of having guidelines for the management of COVID-19 in the current epidemic context and the lack of specific pharmacological treatment, Military Health recommends the launch of a multicenter, randomized, double-blind, interventional clinical trial.

The aim of this study is to evaluate the efficacy of a combination of two treatments, low-dose doxcycline (100 mg/day) and Zinc (15 mg/day) (dietary supplement) in the primary prevention of COVID-19 infection in health care professionals in Tunisia compared to two control groups.


Eligibility Criteria:
Inclusion Criteria:

* No self-medication with study drugs or antivirals
* Negative COVID19 diagnosis confirmed by PCR and negative Elisa antibody assay
* No signs of COVID19
* Having given consent for the study

Exclusion Criteria:

Participation in other clinical trials aimed at primary prevention of VIDOC infection19

* Liver failure
* Known allergy to the study product
* Pregnancy or breastfeeding
* Vitamin A and E treatment in progress
Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)

The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate risk patients will be defined as:

  * PSA 10-20 ng/ml or
  * Gleason score = 7 or
  * Clinical stage T2b/T2c
* Additionally, patients will be required to meet the following criteria:

  * Age \>18
  * KPS \> 80
  * Prostate size \< 60cc
  * Presence of a prostatic lesion with maximum dimension of \>/= 0.5cm and no more than two additional disease foci, each with a maximum dimension less than that of the dominant lesion.
  * International Prostrate Symptom Score \< 15
  * Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria

Exclusion Criteria:

* Prior androgen deprivation therapy for prostate cancer
* Evidence of metastatic disease on bone scan or MRI/CT
* MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator or other implanted metallic or electronic device which is considered MR unsafe, severe claustrophobia or inability to lie flat for the duration of the study, etc.
* Metallic hip implant, metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MP-MRI.
* Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
* Contra-indications to receiving gadolinium contrast
* KPS \< 80
* Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease.
* Prior history of transurethral resection of the prostate
* Prior history of chronic prostatitis
* Prior history of urethral stricture
* Prior history of pelvic irradiation
* History of inflammatory bowel disease
* Unable to give informed consent
* Unable to complete quality of life questionnaires
* Abnormal complete blood count. Any of the following

  * Platelet count less than 75,000/ml
  * Hb level less than 10 gm/dl
  * WBC less than 3.5/ml
* Abnormal renal function tests (creatinine \> 1.5)
Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea

The purpose of this study is to determine if auricular acupuncture significantly reduces post-operative pain in comparison to the standard of care. Post-operative pain score will be collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0= no pain, 10 = worst imaginable pain) up to 10 days post-operation.

DESIGN:

Design type: Prospective, randomized control trial Sample

* Description of the population: All adults, greater than or equal to 18 years, undergoing a tonsillectomy with or without adenoidectomy at Womack Army Medical Center are eligible for participation in the study.
* Sample Size: 100 subjects. A target of 45 subjects per group for a total of 90 subjects, and accounting for a 10 percent drop out rate. In Fiscal Year 12, 92 tonsilectomies in patients over the age of 12 were performed at Womack Army Medical Center. Therefore, the investigators anticipate the study will take up to 4 years to enroll 100 adult subjects.
* Power Analysis: Under the assumption of a linear time by treatment interaction, assuming subject-level randomization, five time-points, power of 80 percent, a Type I error rate of 5 per cent and no attrition, to detect a 1.6 difference in pain score requires a total sample size of 90 subjects or 45 per treatment arm.

Eligibility Criteria:
Inclusion Criteria

* All adults eighteen years of age or older having a tonsillectomy with or without adenoidectomy
* Anesthesiologist classification one to three

Exclusion Criteria

* Chronic pain syndromes or pain symptoms lasting greater than three months or taking opioids on a daily basis for greater than four months
* Anesthesiologist classification four
* Prior neck or throat surgery
* Allergy to gold
Analysis of Emergency Department (ED) Volumes During Natural Disasters

The 'Analysis of Emergency Department Volumes during Natural Disasters' retrospective study focuses on three specified populations including dialysis patients, trauma patients, and patients poisoned by carbon monoxide. These three populations have one commonality - hurricanes, ie. natural disasters, which is the exposure. Causal associations and significant correlations will be explored in all three subgroups.


Eligibility Criteria:
Inclusion Criteria:

* Patients with carbon monoxide poisoning in addition to trauma and dialysis patients admitted to the Memorial Hermann Health System's (MHHS) Emergency Department (ED) 1 week pre- and post-Hurricane Ike's landfall to the City of Houston, which was September 12, 2008.

Exclusion Criteria:

* Patients with the specified conditions that were not admitted during the time interval allotted.
Study to Assess Exactech's Guided Personalized Surgery eGPS® in Total Knee Arthroplasty

Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).

The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.

Eligibility Criteria:
Inclusion Criteria:

* Patient requires a primary Optetrak Logic Total Knee Arthroplasty
* Patient is skeletally mature with no obvious mechanical defect
* Patient is mentally capable of completing follow-up visits
* Patient is 18 years of age or greater at time of surgery
* Patient will be available for follow-up out to 2 years
* Patient has consented to participate in the clinical study

Exclusion Criteria:

* Patient has a mental or physical condition that may invalidate evaluation of the data
* Patient is a prisoner
* Surgery is contraindicated according to the applicable product package insert
* Patient has a local or systemic infection
* Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
* Patient is pregnant