cyrilzakka/clinical-trials huggingface dataset:
Symptom Clusters in Cancer Patients and Their Caregivers- a Longitudinal Study

The complexity of cancer patients' symptoms and health problems constitutes considerable distress and burden for patients and their family caregivers. To help them manage the illness effectively, there is a need to better understand the complexity of symptoms and symptom clusters in patients and caregivers. Therefore, the purpose of this research is to explore a set of important fundamental research questions to advance the scientific knowledge of cancer patients' and caregivers' symptoms, symptom clusters and health-related quality of life. The investigators will follow 500 cancer patients and their caregivers with repeated measures over 6 months to assess their symptoms, symptom clusters, and quality of life over time. Caregiver burden will also be examined in the caregivers.

The specific aims of the study, where we will follow 500 cancer patients and their caregivers with repeated measures over 6 months, are to:

1. Explore cancer patients' symptoms, symptom clusters and symptom changes over time; and identify subgroups of patients with different symptom clusters.
2. Identify genomic markers for the different patient subgroups.
3. Explore symptoms, symptom clusters and burden in caregivers of cancer patients.
4. Explore relationships between patients' and caregivers' symptoms, symptom clusters, quality of life and caregiver burden.

Patients will be asked to complete questionnaires to collect demographic characteristics and self-reported medical history information, a general symptom inventory, specific measures of the symptoms of pain, sleep disturbance, fatigue, depression, functional status and quality of life. The patients' medical record will be reviewed for disease and treatment information.

The caregivers will also be asked to complete questionnaires about a general symptom inventory, specific measures of the symptoms of pain, sleep disturbance, fatigue, depression, functional status, quality of life and caregiver burden.

Data Analyses will be done to identify symptom clusters of the different symptoms, and to identify patient subgroups based on their symptom experience and quality of life. Variations in symptom clusters and quality of life over time will also be evaluated. Genetic analyses will also be done in the patients.

Eligibility Criteria:
Inclusion Criteria for patients are:

* diagnosed with breast, colon, head and neck or ovarian cancer
* receiving active treatment for their cancer (chemo- or radiation therapy)
* above 18 years of age
* able to read / write /speak Norwegian.

Inclusion criteria for caregivers:

* above 18 years
* read and speak Norwegian
* and written informed consent.

Exclusion Criteria:

* patients who had received radiation on the brain as this may affect their abilities to reliably complete questionnaires.
Skin Toxicity Treatment in Metastatic Colorectal Cancer (mCRC) Patients Receiving Panitumumab + Irinotecan-based Therapy

A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in patients with metastatic colorectal cancer (mCRC) who are receiving second-line irinotecan-based chemotherapy concomitantly with panitumumab.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable metastatic adenocarcinoma of the colon or rectum that cannot, in the opinion of the investigator, be cured by surgical resection at the time of randomization;
* Patients who have failed first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with or without bevacizumab for mCRC.

Exclusion Criteria:

• Prior irinotecan use for the treatment of mCRC.
Trazodone for Sleep Disturbance in Early Alcohol Recovery

This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)


Eligibility Criteria:
Inclusion Criteria:

* Completed an alcohol detoxification program.
* Meets criteria for alcohol dependence.
* Meets criteria for sleep disturbance.
* If female of childbearing potential must be using adequate contraception.
* Has a location to which they will return after the initial research interview and a person they regularly contact.
* Speaks English sufficiently to understand instructions and assessment.

Exclusion Criteria:

* Meets criteria for substance dependence for sedative/hypnotic drugs, stimulants, cocaine or opiates, or of organic brain disorder, bipolar disorder, schizophrenia, schizoaffective, schizophreniform, or paranoid disorder, or major depression.
* Current suicidality.
* Use of psychotropic, antidepressant, anxiolytic or antidipsogenic medication.
* Inability or refusal to terminate the use of proerectile agents, herbal medications or sleep medication for the study period.
* The presence of contraindications to the study medications, including pregnancy/lactation, ischemic heart disease, cardiac arrhythmias, priapism or hypotension.
* Presence of comorbid medical conditions associated with sleep disturbance including obstructive sleep apnea, poorly controlled diabetes mellitus or emphysema.
* Evidence of neuropsychological dysfunction.
* Probation/parole requirements that might interfere with participation in study.
* Inability to identify at least one contact person.
* Living on the street after detoxification (homeless persons living in a shelter, halfway house or other residence will not be excluded).
Modified Intraocular Lens to Reduce Eye Inflammation After Cataract Surgery in Uveitis Patients

This study will test the effectiveness of an intraocular lens treated with heparin in reducing or preventing inflammation after cataract surgery in patients with uveitis.

Patients with uveitis (inflammatory eye disease) often develop cataracts (clouding of the lens of the eye) that can impair eyesight. Cataracts can be removed surgically, and this is usually done when poor vision interferes with adequate daily functioning, or when the lens becomes too cloudy to evaluate the level of eye inflammation in uveitis-information needed to adjust medication dosages. After surgery, vision is corrected with special eyeglasses, contact lenses, or intraocular lenses (IOL). IOLs are small, plastic artificial lenses permanently placed inside the eye.

Patients with uveitis who require cataract surgery and whose eye inflammation has been controlled by medicine for at least 3 months may be eligible for this study. Those enrolled in the study will be randomly assigned to one of two treatment groups: one group will have a standard IOL implanted during cataract surgery; the other will receive a heparin-treated IOL.

Before surgery, patients will undergo standard preoperative tests, including chest X-ray, electrocardiogram, blood tests and urinalysis, as well as an eye examination that includes photography of the cornea, iris and retina. Additional tests and examinations to be done at the start of the study and at periodic follow-up visits for about 1 year may include: fluorescein angiography to evaluate the blood vessels of the retina; specular microscopy to examine the surface of the IOL; cell and flare measurements to evaluate inflammation, and ultrasound to examine the back of the eye.

The purpose of this project is to evaluate the ability of a heparin-surface modified intraocular lens to reduce the incidence and severity of post-operative inflammation in patients with uveitis undergoing extracapsular cataract surgery. Patients who have a history of uveitis and have been in remission on steroids and/or cyclosporine or cytotoxic agents for at least three months will be considered for this study. They will be randomized in a masked fashion to either a surface-modified lens or to a non-modified lens of similar design. The intraocular inflammation will be assessed using standardized clinical criteria, and by a laser cell flare meter at those sites using this equipment. The presence of inflammatory cells on the lens surface will be assessed using specular micrography. In an initial period, the study will only be carried out in the Clinical Center of the National Eye Institute (NEI) at the National Institutes of Health (NIH). However, in order to complete the study in a reasonable period of time, it may be expanded to include several outside centers.

Eligibility Criteria:
Follow-up Only.
Effect of Kinesio Taping on Pulmonary Function and Forward Shoulder Posture FSP of Young Adults

The aim of the study is to evaluate the effect of kinesio taping on pulmonary function and forward shoulder posture in young adults. Limited literature shows an association between forward shoulder posture and pulmonary function but the effect of kinesio taping for correction of forward shoulder posture and its consequences on pulmonary function is lacking in previous studies.

Electronic devices and gadgets are mostly used for official and personal needs in this modern era. This increased usage leads to poor posture, especially in young adults. The FSP is the most common incorrect posture in youngsters. A study on posture correction shows the prevalence of rounded shoulders is 84% in the young adult age group of (18 to 24 years). The misaligned posture causes changes in anatomical structure leading to many musculoskeletal problems. Along with the musculoskeletal system, FSP also decreases chest wall mobility, lung capacities, and overall respiratory function. The respiratory muscle's proper functions is need to expand the thoracic cavity . The pectoralis muscles function is to elevate the rib cage and its tightness leads to lower chest expansion. Rhomboids play a role in stabilizing the scapula which helps the serratus muscle in forced inspiration. Weakness of middle and lower trapezius muscles causes the inability to straighten the back, thus affecting the ability to raise and expand the chest properly. Currently, for posture correction, usually in the form of conservative treatments such as stretching and strengthening exercises, McKenzie's exercises, Pilates, shoulder support braces, electrical modalities, etc are used to correct or reduce FSP. It is a dire need to find out the best physiotherapy approach for the correction of forward shoulder posture as well as improvement in pulmonary function that is not time-consuming like other exercise interventions. If the effectiveness of kinesio taping on pulmonary function is verified it will contribute to future use as the most suitable and less time-consuming approach in youngsters with FSP.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female participants
* Age: 18 - 25 years
* BMI within the normal range (18.5 to 24.9)
* Healthy participants with FSP

Exclusion Criteria:

* Skin allergies to elastic tape
* Known case of smokers
* Known cases of cardiovascular and pulmonary problems.
* Subjects with musculoskeletal disorders
* History of chronic neck or shoulder pain (NPRS \>3)
* Any deformities or any condition that make it difficult to apply the Kinesio-Tape
* Those who refuse to participate
* Previous experience in respiratory muscle training
Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers

This study explored the impact of food on skin and plasma pharmacokinetics of doxycycline

Sub-antimicrobial dose doxycycline is approved for the treatment of rosacea. This work investigated the pharmacokinetics of doxycycline in skin and plasma of fed and fasting healthy volunteers receiving a 14-day treatment course with once daily 40 mg doxycycline. Dermal measurements were performed by means of in vivo microdialysis.

Eligibility Criteria:
Inclusion Criteria:

Healthy males

* Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Investigator/Sub-Investigator
* Signed written informed consent prior to inclusion in the study
* 18-45 years old inclusive
* BMI: 18.5 to 30 kg/m2
* SBP: 100-139 mmHg
* DBP: 55-89 mmHg
* PR: 55-100 bpm (measured after 5 min of rest, sitting position)
* ability to comprehend the full nature and purpose of the study, including possible risks and side effects
* ability to co-operate with the Investigator and to comply with the requirements of the entire study
* availability to volunteer for the entire study duration and willing to adhere to all protocol requirements

Exclusion Criteria:

Any clinically relevant abnormalities in ECG (12 leads)

* Any clinically relevant abnormal physical findings
* Any clinically relevant abnormal laboratory values indicative of physical illness
* Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drug or to tetracyclines in general
* History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
* Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
* Any psychiatric illnesses
* Presence of any skin condition that would interfere with the placement of microdialysis probes
* Any dermatological drug therapy on the surface of both thighs within 14 days before study day 1 of this study
* Use of any medication(including OTC) within 1 week prior to study day 1
* Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort) within 1 month prior to study day 1
* Participation in another clinical study investigating another IMP within 1 month prior to study day 1
* Blood donations within 1 month prior to study day 1 or planned within 1 month after the last study-related blood draw
* History of drug or alcohol abuse (\>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
* other objections to study participation in the opinion of the Investigator
A Study in Subjects With Perennial Allergic Rhinitis

The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
* Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
* Have not started or had a change in immunotherapy regimen.

Exclusion Criteria:

* Have a physical obstruction in the nose.
* Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
* Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
* Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
* Have asthma of sufficient severity to require use of excluded medications.
* Have taken any medications excluded as listed in the protocol.
* Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality.
* Are a current smoker, recent smoker or past smoker as defined in the protocol.
Multicenter Prospective Trial on Hemorrhoids

This study will compare Ferguson hemorrhoidectomy and THD in terms of one-year recurrence in a large population (N=492). Recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.

This is a multicenter, parallel arm, non-randomized prospective data collection trial comparing Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. All subjects will already be scheduled for either Ferguson or THD hemorrhoidectomy, the surgery is NOT part of the research. Although a randomized study would control for variation among surgeons, this study design provides the best patient safety since the surgeons will perform the technique they do most frequently. Variability in the patient population will be managed with a conservative sample size, which allows for a multivariate analysis of the sample populations if any confounding variables are noted during initial data analyses. In addition, the variability will be minimized with stringent and detailed inclusion/exclusion criteria in terms of hemorrhoidal disease. Patients will be enrolled and followed for one year. Participating surgeons will be credentialed and each participating surgeon will enroll up to ten consecutive patients.

The primary endpoint of this study is to compare Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. Recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.

Eligibility Criteria:
Inclusion Criteria:

Patient must be:

* At least 18 years-old
* Able to sign informed consent
* Presenting with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns at physical examination and scheduled for either Ferguson or THD hemorrhoidectomy.

Exclusion Criteria:

* Any prior anorectal surgery except for conventional office-based interventions (rubber band ligation, sclerotherapy, and infrared coagulation)
* Prior pelvic radiotherapy
* Inflammatory bowel diseases
* Pre-existing fecal incontinence (Wexner score5 ≥8)
* Pre-existing chronic anal diseases
* Grades III and IV gynecological and obstetrical trauma per medical history and/or physical examination
* Connective tissue disorders
* Subject is pregnant
* Subject is under incarceration
Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational Anaesthesia

The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs and must be compensated for by increased ventilation. This study aims at determining how much compensation must be given, based on the hypothesis that rebreathing depends on carbon dioxide level in blood and exhaled air.


Eligibility Criteria:
Inclusion Criteria:

* elective coronary artery by-pass graft surgery
* elective valve replacement surgery
* normal left ventricular ejection fraction on preoperative echocardiography

Exclusion Criteria:

* obstructive lung disease
* restrictive lung disease
Oral Health Promotion Program for Persons With Severe Mental Illness

A cluster randomized controlled study was carried out in chronic psychiatric wards of a general hospital in central Taiwan. Sixty-eight eligible male individuals admitted to 2 wards were randomly assigned to an experimental and a control group. Participants in the experimental group underwent an oral health promotion program that consisted of biweekly group education sessions, and a 12-week individual behavioral modification for oral hygiene course. The participants in the control group received usual care only. Dental plaque (measured by the Plaque Control Index) was examined by a single dentist before and after the experiment.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in chronic psychiatric wards were eligible.

Exclusion Criteria:

* significant cognitive disabilities, severe hearing impairment, orthodontic appliances, an edentulous status, or a handicap when tooth-brushing
Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy Volunteers

This is a single center, two-period, randomized study to evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female participants between 18 to 55 years (inclusive).
* Have a Body Mass Index (BMI) of \> 18.0 and \< 30.0 kg/m2; (BMI = weight (kg)/ \[height (m)\]2).
* Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
* Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.

Exclusion Criteria:

* Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
* Pregnant or nursing (lactating) women.
Investigating the Effects of Different Soft Tissue Mobilizations on Delayed Onset Muscle Soreness

Delayed onset muscle soreness (DOMS) is associated with the initiation of a new physical activity or a sudden increase in exercise volume and intensity. DOMS also occurs following eccentric exercises such as ballistic stretching, downhill running, weight training and plyometrics. DOMS might prevent performing sports and decreases the performance of professional or recreational athletes. Recently, different soft tissue mobilization applications (massage, foam roller) have been preferred by many athletes to prevent DOMS. However, there is no study comparing the effects of these techniques on DOMS. Therefore, the aim of the present study is to investigate the effects of different soft tissue mobilization practices on DOMS and sportive performance in recreational athletes. In order to achieve this goal, a total of 36 recreational athletes will be included and will be allocated to three groups as foam roller group (n=12), massage group (n=12) and control group (n=12). Demographic data, thermal camera measurements, fatigue level assessments, and performance measurements will be performed. All measurements will be carried out four times as before the application, immediately after the application, after 24 hours and after 48 hours.

After being invited to the study, the demographic data of all participants who agreed to participate in the study will be recorded on a structured form. Participants will be randomly divided into three groups: Massage application group, Foam Roller application group and Control group. Afterwards, thermal imaging, perceived fatigue and pain level, blood lactate level measurements, and vertical jump assessments will be done for the quadriceps femoris muscle. Then, the fatigue protocol will be applied for the quadriceps femoris muscle and five-minute applications will be made according to the groups in which they are randomly separated. Evaluations made in the first applications will be made immediately after the applications, 24 hours and 48 hours later, as the 2nd, 3rd and 4th measurements. The assessor will not know which group the participants are from.

Eligibility Criteria:
Inclusion Criteria:

* Performing recreational sports at least 1 and at most 3 times a week.

Exclusion Criteria:

* Any musculoskeletal, neurological or other serious health problems experienced in the past six months
* Not willing to participate in the study