cyrilzakka/clinical-trials huggingface dataset:
Collection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid Tumors

RATIONALE: Collecting and storing samples of tissue or blood from patients with cancer for study in the laboratory may help the study of cancer in the future

PURPOSE: This research study is collecting and storing blood and tissue samples from patients with suspected solid tumors.

OBJECTIVES:

* To provide a tissue and cell repository to be used by Wake Forest University Comprehensive Cancer Center (WFUCCC) investigators.
* To provide specialized research pathology services to these investigators.

OUTLINE: Tumor and normal tissue in the resected specimen (when possible) are harvested and collected from patients undergoing planned surgery or biopsy. Additionally, any normal tissue and/or fluid removed in the course of the operation (e.g., cerebrospinal fluid during brain tumor resection) may also be stored for use in analyzing changes from normal tissue to cancerous tissue. Specimens are rapidly frozen in liquid nitrogen to preserve the mRNA, proteins, lipids, and DNA in the samples for future analysis. Tissue is stored for research projects on tumors and treatment of cancer patients. Research may involve analysis of the genetic makeup of the tumor tissue. Genes may be cloned and living cells cultured from the stored tissue. Blood is also collected during surgery. Samples are maintained and cataloged for future retrieval.

Information about medical history is collected from patient medical records. This information includes the following: medical diagnosis; specific information about treatment; other medical conditions; medical data (i.e., laboratory test results, tumor measurements, CT scans, MRI scans, x-rays, and pathology results); side effects experienced and treatment for side effects; long-term information about general health status and the status of disease; data that may be related to tissue and/or blood samples collected; and identifying numbers or codes (i.e., social security number and medical record number).

Eligibility Criteria:
Inclusion Criteria:

* Clinically suspected solid tumor AND scheduled for surgical resection and/or biopsy
Voice Changes During ECT

Depressed patients talk differently when they are depressed compared to when they are well. But it is hard to actually measure what the differences are. The study team will record voice samples from patients with mood disturbances, like depression, over the course of their receiving an electroconvulsive therapy (ECT) series. The study team will try and measure or quantify exactly what has changed in their speech and voice. The study team will choose ECT as it is one of the most effective and rapid treatment for depression. The study team will use a service provided by a company, NeuroLex, who has complex computer programs (artificial intelligence, AI) to analyze the voice samples.


Eligibility Criteria:
INCLUSION CRITERIA:

* Any candidate for electroconvulsive therapy who is about to initiate their ECT course at Medical University of South Carolina (MUSC) for a clinically indicated diagnosis
* Age 18 to 90 years old
* Able to speak and understand English
* Able to give consent to participate in the study

EXCLUSION CRITERIA:

* Any medical condition that limits the ability to speak or speak clearly, for example a history of head and/or neck cancer, spinal cord injury affecting speech, amyotrophic lateral sclerosis, or those with absence of critical anatomical structures involved in speech.
* Any voice characteristics that may limit the ability to speak English clearly including speech impediments or heavy accents (as evidenced by the pronunciation of the English language in such a non-standard way that research staff). If study staff have significant difficulty understanding the participant's responses in conversation, this may warrant exclusion.
* Patients who are receiving ECT by involuntary order, by order of their guardian, or by a court order, as evidenced by patient report or brief chart review.
* Patients who elect to not receive their full course of ECT at MUSC.
FERTI-LILY Safety Study

The study is a prospective, 1-arm, open label, nonrandomized, single center study designed to evaluate label comprehension, device usability and safety of the FERTI·LILY Conception Cup. The primary safety endpoint will be an assessment of reported adverse events.

Subjects will be screened -10 (±3) days prior to the baseline visit. At baseline, 15-20 subjects meeting the inclusion/exclusion criteria will be provided with a FERTI·LILY Conception Cup device and instructions for using the device. Subjects will participate in a label comprehension protocol that includes the physician confirmation that they have adequate comprehension to enroll. If not, a screen failure form is completed.

Subjects will agree to try and use the device within 2 weeks of disposition therefore at baseline a two-week visit is scheduled. In the event they do not use the device within the two-week period the follow up visit can be rescheduled based on the visit window of +14 days. If it is not used within 4 weeks, the PI will have the subject return to the site to authorize another two-week period that will be captured as unscheduled follow up visit. The subject should complete the Device Experience Survey after each device use. The Device Experience Survey will be returned at this time, and adverse events will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a female volunteer, age ≥ 18 years.
* Subject is willing and able to provide written informed consent for study participation.
* Subject agrees to use the FCC device as directed.
* Subject agrees to complete all study-related assessments.
* Subject agrees to try to use the cup within two weeks of disposition.
* PI confirms that the subject had the adequate label comprehension to enroll in the study.

Exclusion Criteria:

* Subject has a medical condition or other factor that, in the opinion of the investigator, would contraindicate participation in the study.
* Subject has active bacterial vaginosis infection or vaginismus.
* Subject has an abnormal clinically significant Pap Smear diagnosis.
* Subject has a history of endometriosis.
* Subject has any contraindications with the Instructions for Use.
* Subject has an allergy to silicone.
* Subject is pregnant or lactating.
Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support

The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.


Eligibility Criteria:
Recipient Inclusion Criteria:

* Confirmed diagnosis of COVID-19 by RT-PCR;
* Time between symptom onset and inclusion ≤ 7 days;
* Chest tomography with \<50% involvement of the lung parenchyma;
* No indication of ventilatory support at the time of randomization;
* Sign the consent form.

Recipient Exclusion Criteria:

* Contraindication to transfusion or history of previous reactions to blood products for transfusion;
* Pregnant women;
* Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.

Donor Inclusion Criteria for Plasmapheresis:

* Convalescent plasma donation will be eligible for patients ≥ 18 years old who had previously confirmed COVID-19 by RT-PCR, which met the criteria adopted by technical notes n13 and 21/2020-CGSH/DAET/SAES/MS;
* SARS-COV-2 negative RT-PCR;
* Asymptomatic for at least 14 days;
* SARS-CoV-2 anti-peak titre with dilution ≥ 1: 320;
* Sign the consent form.

Donor Exclusion Criteria:

* Female gender with previous pregnancy;
* Absence of peripheral venous network compatible with the apheresis procedure;
* Positive or indeterminate result in any of the infectious screening tests;
* Presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum.

Chronic obstructive pulmonary disease (COPD)is a multifactorial, progressive chronic lung disease that causes airflow restriction. Study was conducted To Compare the effects of supervised and self-directed pulmonary rehabilitation on cough and sputum expectoration in patients of chronic obstructive pulmonary disease.

To Compare the effects of supervised and self-directed pulmonary rehabilitation on cough and sputum expectoration in patients of chronic obstructive pulmonary disease. It was a randomised control trial and participants were COPD Patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40 to 60
* Gender: Both Males \& Females.
* Diagnoses with an exacerbation of COPD.
* Informed consent obtained.

Exclusion Criteria:

* Inability to provide informed consent or complete a self-administered questionnaire.
* Patients with trauma.
* Females who were pregnant and breastfeeding.
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain

The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe knee or hip pain in patients with a diagnosis of osteoarthritis.

This current study is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the safety and effectiveness of different doses of JNJ-42160443 compared with placebo in the treatment of patients with a diagnosis of osteoarthritis of the hip or the knee who have moderate to severe pain that is not controlled by standard pain medications.Osteoarthritis is a chronic disease that affects the joints, and is characterized by degeneration of cartilage and bone. The duration of the study is approximately 133 weeks (3-week screening phase, 12-week double-blind efficacy phase, 92-week double-blind extension phase, and 26-week post treatment phase).JNJ-42160443 (10 mg/mL) or matching placebo given as an subcutaneous (injection under the skin) (SC) once every 4 weeks will be administered in the study as 1 of 5 JNJ-42160443 dosages:1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks; or 10 mg every 8 weeks, or matching placebo for up to approximately 104 weeks (12-week double-blind efficacy phase + 92-week double-blind extension phase).

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of osteoarthritis of the hip or the knee; Have an average daily pain intensity score of \>=5 averaged over the last 3 days before treatment assignment; Receiving a stable dose of non-steroidal anti-inflammatory drugs for a minimum of 5 days each week for the 4 weeks before screening or a stable dose of immediate-release opioids for a minimum of 5 days each week for the 4 weeks before screening, but not exceeding 200 mg oral morphine equivalents per day or a stable dose of long acting opioids for the 4 weeks before screening; but not exceeding 200 mg oral morphine equivalents per day; Have a mini mental state examination score of \>=26 at screening. Exclusion Criteria:History within the past year of any of the following: seizure disorder; intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, transient ischemic attack, meningitis; History of brain injury within the past 15 years consisting of \>= 1 of the following, or with residual sequalae suggesting transient changes in consciousness: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 hours; History of epilepsy or multiple sclerosis; Current diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), study joint pain caused by secondary infection, or pain caused by confirmed or suspected neoplasm; Any new or unresolved neurologic deficits, including progressive deficits, within 6 months before screening
Epidemiology of Pediatric Asthma Hospitalization

To study three possible, but yet unproven, influences on pediatric asthma hospitalization rates - diagnostic substitution, different systems of medical care, and asthma medication use.

BACKGROUND:

Recent research has shown that asthma admission rates for children vary widely across geographic areas and have increased nationally for the past decade. The results from these studies will have direct relevance to the clinical care and development of public policy for children with asthma.

DESIGN NARRATIVE:

Specific hypotheses regarding these factors which influence pediatric asthma hospitalization were tested in two different data sets: ecologic studies of trends and area variations of the children residing in the contiguous states of Maine, New Hampshire, and Vermont for 1980 - 1994; retrospective cohort analyses of children enrolled at a staff model HMO, Group Health Cooperative of Puget Sound for 1977 - 1994. These studies utilized detailed information regarding area and individual 'exposure' to differing systems of health care and asthma medications, controlling for socioeconomic status.

Eligibility Criteria:
No eligibility criteria
Oxaliplatin/CPT-11 for Extensive Stage Small Cell Lung Cancer

The purpose of this study is to determine the safety and effectiveness of the combination of oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated extensive small cell lung cancer
* No prior chemotherapy
* No prior radiotherapy except for the treatment of brain metastases

Exclusion Criteria:

* Prior treatment for extensive stage small cell lung cancer
* Known hypersensitivity to any of the components of oxaliplatin or CPT-11
* Greater than grade 2 peripheral neuropathy
* Known HIV or Hepatitis B or C (active, previously treated or both)
Cross-Cultural Validity of EDI-1 Among Clinical and Non-Clinical Taiwanese Population

The aim of the study is to understand the clinical characteristics of Taiwanese eating disorders as well as establishment of the psychometric properties of eating disorder-related questionnaires (EDI and BITE).

The study subjects include three group of population: 1st group is non-clinical nursing college students (N=800); 2nd group is clinical eating disorder patients (N=600) and 3rd group is age-, sex-matched clinical non-eating disorder patients (N=600). Clinical patients are screened by eating disorder module of the SCID and are grouped into eating disorder or non-eating disorder group. After written informed consent, eating disorder patients will receive clinical assessments which included important clinical characteristics and psychopathology of eating disorders by experienced senior psychiatrists. All clinical patients are asked to complete the self-rating scales which included eating and general psychological functioning questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* patients with eating disorders,
* patients with non-eating disorders,
* nursing school students

Exclusion Criteria:

* None
Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly

The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of elderly patients, the therapeutic resources to control the passing pain require in their manipulation a certain caution and are not divested of side effects badly tolerated at this age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative of choice in the care of these pains, in particular in case of pre-existent cognitive achievement, of polypathologies or of polymédication.

The gas MEOPA administered to the mask could thus be an effective additive in the physiotherapy treatment of the elderly person.

The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 65 years old or more
* Patients having a prescription for physiotherapy
* Absence of contraindication to MEOPA
* Patients whose initial assessment show a passive articular deficit of at least a joint of hip or the knee and whose painful assessment is ≥ 5 or ≥ 2 during mobilisation on the validated scale Algoplus
* Patients whose reeducation project established by the physiotherapist
* Patients having agreed to participate in the study and having signed the consent
* Subjects affiliated to the social security system

Exclusion Criteria:

* Patient requiring a ventilation in pure oxygen
* Patient with a consciousness deterioration preventing his cooperation
* Care under MEOPA during the period of the protocol and during the month which precedes
* Increase of the dosage of morphine of less than 48 hours Patient under guardianship
Conservative or Operative Treatment for the Shoulder Impingement Syndrome?

Study hypothesis: The impingement syndrome of the rotator cuff is a common cause of shoulder pain for which the most effective treatment is unknown. Steroid injections and anti-inflammatory analgetics are considered as effective methods. Physiotherapy and acromioplasty are commonly used treatments.

Hypothesis: Arthroscopy and acromioplasty in addition to conservative treatment is equally effective as conservative treatment alone for shoulder impingement syndrome.

The aim of this study was to examine the effectiveness of arthroscopic acromioplasty in the treatment of the shoulder impingement syndrome. Nonoperative treatment consisted of information given by a trained physiotherapist. The patients were supervised with a progressive programme to improve the mobility and muscle strength of the shoulder region which was regularly controlled. The exercises aimed at strengthening the stabilising muscles of the glenohumeral joint (m. trapezius, m. deltoides, m. supraspinatus and m. infraspinatus) and activating the decompressive muscles of the the subacromial space (m. teres major and minor, m. subscapularis). The programme lasted for three months. In addition the patients were given advice for daily home exercise.

In the surgical group the patients underwent an arthroscopic examination and acromioplasty done by one experienced orthopaedic specialist. Postoperatively the patients received similar physiotherapeutical information and training programme than in the conservative treatment group.

The follow-up evaluations were performed at 3, 6 and 12 months from the beginning of each treatment in addition at 24 months counted from the randomization. A trained research physiotherapist who was blinded to the treatment group and had not been involved in their treatment performed a standardized assessment of all patients. The range of motion, muscle strengths and Neer´s tests were recorded. At each evaluation the patients completed a structured questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* a positive clinical Neer's test
* shoulder pain resistant to rest
* shoulder pain resistant to anti-inflammatory drugs
* shoulder pain resistant to subacromial steroid injections
* shoulder pain resistant to ordinary physiotherapy with a minimum history of three months

Exclusion Criteria:

* glenohumeral or acromioclavicular arthritis
* glenohumeral instability
* total rupture of the rotator cuff
* cervical syndrome
* adhesive capsulitis
* neuropathy of the shoulder region
Probiotic Visbiome for Inflammation and Translocation in HIV Ι

Modern antiretroviral therapy (ART) has transformed the clinical care and lived experience of HIV infection. However, increased rates of adverse health conditions that are related to immune activation, such as cardiovascular disease (CVD) and neurodegenerative disease in ART-treated individuals persist. An important cause of this inflammation is the gut CD4 T cell loss and the "leaking" or translocation of luminal gut bacteria and other microbes across the bowel wall and into the bloodstream.

The use of complementary and alternative therapies is common among people living with HIV, however their efficacy has generally not been well demonstrated. Probiotics are live microbes that may provide a health benefit to the host and the investigators believe that the simultaneous use of probiotics along with antiretroviral therapy (ART) will improve gut CD4 T cell restoration and function and therefore reduce microbial translocation and immune activation.

Probiotic Visbiome consists of a high potency blend of eight different probiotics. The precise mechanism of action of Visbiome is unknown, but preclinical studies have shown that Visbiome may modulate the immune response towards a phenotype that is associated with reduce inflammation, and Visbiome was also protective in a non-human primate model of SIV infection. Therefore, we believe that the "beneficial" bacteria from Visbiome will accelerate the normalization of gut immune cells and function in HIV-infected individuals as they start ART. Early resolution of gut immune cells may normalize microbial translocation and immune activation and will reduce the rates of HIV-associated comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection
* Male adult (age \>18 years)
* Antiretroviral therapy-naïve
* Ability to provide informed consent
* HIV-1 viral load ≥1,000 copies/ml

Exclusion Criteria:

* Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance
* Taking pharmaceutical grade probiotics
* Any of the following abnormal laboratory results in screening:

  * Hemoglobin \<85 g/L
  * Neutrophil count \<750 cells/μl
  * Platelet count \<50,000 cells/μl
  * AST or ALT \>5X the upper limit of normal
* Malignancy
* Colitis
* Liver fibrosis (decompensated cirrhosis), portal hypertension or clinical hepatitis
* Other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death