cyrilzakka/clinical-trials huggingface dataset:
Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

This study is a 2X2 factorial randomized trial that will the examine the comparative effectiveness of two patient decision aids for hip and knee osteoarthritis (OA) as well as the impact of a surgeon-focused intervention.

This study is a 2X2 factorial randomized trial that will examine the comparative effectiveness of different decision support strategies for patients making treatment decisions about hip or knee osteoarthritis (OA). Eligible patient subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating orthopedic specialist. Participating providers are randomly assigned to either usual care or an intervention (a report that includes patients' goals and treatment preferences). Patient participants will complete three surveys at different time points: before their orthopedic visit, one week after the clinic visit, and 12 months later. Providers will complete a short survey for a subset of patient participants. The study is titled the DECIDE-OA study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either hip or knee osteoarthritis
* Scheduled visit with participating orthopedic surgeon

Exclusion Criteria:

* prior partial or total knee or hip joint replacement within last 5 years
* hip fracture or asceptic necrosis (AVN) in last 12 months
* Rheumatoid arthritis
* Psoriatic arthritis
* Unable to read English or Spanish
* Unable to consent for self due to cognitive or medical issue
* Hip or knee decision aid provided by Partners Healthcare clinician within 12 months
Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

The objective of this study is to assess the efficacy of an implantable etonogestrel device in reducing hysterectomy rate in patients with a failed endometrial ablation.

The researchers aim to determine whether use of etonogestrel implant in patients with failed endometrial ablation significantly decreases hysterectomy rate. Changes in pelvic pain and vaginal bleeding will be assessed. Time to hysterectomy will be examined.

The researchers hypothesize that treatment of failed endometrial ablation with etonogestrel implant will decrease pelvic pain and vaginal bleeding resulting in a significantly decreased need for hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Previous endometrial ablation
* Pelvic pain and/or vaginal bleeding seeking treatment

Exclusion Criteria:

* Previous or current VTE
* Liver tumour, benign or malignant, or active liver disease
* Undiagnosed abnormal genital bleeding
* Known or suspected breast cancer
* Uncontrolled hypertension
* Allergy to component of etonogestrel implant
* Lack of patient consent
Establishing a Repository of Blood and DNA Samples From People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Genotype-Phenotype Database and Sample Repository)

Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. The purpose of this study is to collect, test, and archive blood and DNA samples from children and adults with SCD to study the role that genes play in SCD. Blood and DNA samples will be stored for use in future SCD studies.

SCD is an inherited blood disorder that is caused by an abnormal type of hemoglobin. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." The Comprehensive Sickle Cell Centers (CSCC) is a network of 10 centers that conduct research to improve health care and treatment options for people with SCD. The Collaborative Data Project (C-Data) is a CSCC study that is establishing a comprehensive database of children and adults with SCD who are receiving medical care at participating CSCC research centers. This study will initiate the development of a centralized laboratory that will collect, test, and archive blood and DNA samples from participants in the C-Data project for use in future SCD studies. The collection of blood and DNA samples will provide researchers with an important resource to better define the genetic diversity of SCD. In the future, genotype-phenotype correlation studies, population studies, and various other genetic studies may be conducted.

This study will enroll participants taking part in the C-Data project. For this study, participants will undergo a blood collection. The blood sample will then be sent to a lab to characterize the red blood cells and hemoglobin. DNA will be analyzed to identify genes that influence the severity of SCD. Blood and DNA will be stored for future genetic research in SCD and closely related disorders.

Eligibility Criteria:
Inclusion Criteria:

* Participating in the C-Data project

Exclusion Criteria:

* Unable to undergo blood collection
Validation of Clinical Assessment of Spinal Stiffness

This study aims to validate and verify the reliability of the clinical measures used in the daily routine by doctors and therapists that allow assessing the spinal stiffness in all spatial planes. The secondary objective is the verification of the diagnostic accuracy of the most reliable tests in identifying the subjects at risk of failure, using as a radiographic standard the examinations performed by the patients during the treatment (data retrieved retrospectively) using as a control group those patients who did not obtain a correction of the spine curvature.


Eligibility Criteria:
Inclusion Criteria:

* Scoliosis \> 10°Cobb or Hyperkyophosis \>50° Cobb
* Age between 10 and 17 years old
* Risser between 0 and 5

Exclusion Criteria:

* History of spinal surgery
* Presence of back pain
* Diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases
Development and Preliminary Testing of a "Papageno"-Story Interview Intervention- Aim 3

The purpose of this study is to determine the effects of a short "Papageno story" video of a compilation of interviews on proximal risk factors for suicide. The researchers believe that the intervention may increase protective factors related to suicide.


Eligibility Criteria:
Inclusion Criteria:

* People who are part of an existing cohort within DesignXM
* They will also answer yes to the question: "In the past 1 year, have you wished you were dead or wished you could go to sleep and not wake up?"

Exclusion Criteria:

* No exclusions if all inclusion criteria is met
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia

This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in up to 30 adult female and male subjects (18 to 50 years of age) with a documented medical diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH). The study will include a sequential-cohort design with four NBI-74788 dosing regimens, with each regimen administered for 14 days.


Eligibility Criteria:
Inclusion Criteria:

1. Be in good general health.
2. Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH.
3. Be on a stable regimen of steroidal treatment for CAH that is expected to remain stable throughout the study.
4. Subjects of childbearing potential must be instructed on the proper use of barrier methods of contraception and agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently from screening until the final study visit or a prespecified window after the last dose of study drug, whichever is longer.
5. Subjects of childbearing potential must have a negative pregnancy test at screening and negative urine pregnancy test at baseline.
6. Have a negative urine drug (for illegal drugs) and alcohol breath test at screening and baseline.
7. Be willing and able to adhere to the study regimen and study procedures described in the protocol and informed consent/assent form, including all requirements at the study center and return for the follow-up visit.
8. Be willing to provide authorization for access to personal health information in conjunction with US Health Insurance Portability and Accountability Act (HIPAA).

Exclusion Criteria:

1. Have a clinically significant unstable medical condition or chronic disease, or malignancy.
2. Had a medically significant illness within 30 days of screening.
3. Have a known or suspected differential diagnosis of any of the other known forms of classic CAH.
4. Have a history that includes bilateral adrenalectomy, hypopituitarism, or other condition requiring daily therapy with orally administered glucocorticoids.
5. Are pregnant or lactating females.
6. Have a history of epilepsy or serious head injury.
7. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
8. Have hypersensitivity to any corticotropin releasing hormone antagonists.
9. Test positive at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), or have a history of a positive result.
10. Have a recent history (≤1 year) of alcohol or drug abuse, or current evidence of substance dependence or abuse criteria.
11. Used any anticoagulants or antiplatelet therapies within 30 days before screening.
12. Have an active bleeding disorder.
13. Used any other investigational drug within 30 days before initial screening, or plans to use an investigational drug (other than the study drug) during the study.
14. Have a blood loss ≥550 mL or donated blood within 56 days or donated plasma within 7 days before baseline.
Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery

Over the last months, the Rizzoli Orthopedic Institute in Bologna, Italy, has drained orthopedic urgencies from all other hospitals in the urban and suburban area. In this context urgencies are defined as fractures and primary or metastatic bone lesions with indication to non-deferrable surgery. A subset of these patients tested positive for SARS CoV 2, either before or after the surgical procedure.

Anesthesiological clinical management of covid19 cases is complicated by the consequences of the viral infection on respiratory and cardio-vascular systems, renal function and coagulation. Similarly, management of asymptomatic patients is challenging because of the lack of data on possible specific complications.

This study will report a snapshot of our early experience on perioperative clinical management of patients undergoing orthopedic surgery in the presence of SARS CoV 2 infection, ascertained or not at the time of surgery.

This is a monocentric, retrospective, observational study.

the study will analyze all medical records of patients that underwent major or non-delayable orthopaedic surgery from the 1st of March 2020 to the 30th of June 2020 with known ongoing Coronavirus infection or postoperative diagnosis via nasal swab test collected at Rizzoli Orthopaedic Institute.

Medical history, anthropometrical, clinical, radiological, and biochemical data will be inserted in a database.

Primary objective will be to estimate population mortality in the time frame from surgery to hospital discharge.

Secondary objectives will be estimation of correlation between SARS-CoV2 infection and main postoperative complications. Mortality and site infection rate will be compared among the cohort and pre-COVID19 similar data.

Continuous variables will be summarized using median and interquartile range while dichotomic variables will be expressed as absolute and relative frequencies. Frequencies and outcomes will be reported as absolute frequency (observed / total) and relative percentage. Association between independent variables and outcomes will be tested with multivariate analysis, hypothesis testing (t-test or Mann-Whitney) and Fisher's exact test according to the type of variable and its distribution (and the experimental question at hand). Variables showing statistically significant association (p\<0.1), will be used to build a multivariate logistic regression model with dichotomic dependent variable. Statistical significance threshold will be set to 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients urdergoing non-deferrable Orthopaedical surgery
* Ascertained SARS-CoV-2 infection detected by nasopharyngeal swab before of after the surgery
* Written, signed informed consent to the trial.

Exclusion Criteria:

* Lack of signed informed consent.
Translation and Validation of Cognitive Failure Questionniare in Urdu Among Elderly.

study is based on translation of Cognitive Failure questionnaire in URDU and thrn to check its reliability an Validation in Elderly


Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients Participants belonging to Urdu speaking class.

Age should above 60 years Participants should be capable to complete the questionnaire without any help. Participants with mild cognitive impairment.

Exclusion Criteria:

* Individual below 60 years. Participants not capable to complete the questionnaire without any help. Participant who can't understand urdu
Emotional Burden of Healthcare Professionals and Covid Infection 19

COVID-19 ( known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) has a highly polymorphic clinical presentation, ranging from pauci-symptomatic infection to severe, potentially complicated forms with acute respiratory distress syndrome or multisystemic organs failure. The picture may be initially severe, or it may progress in two stages, with worsening 7 to 10 days after the first symptoms with an overall case-fatality rate of 3 to 4%.

Its management is essentially symptomatic, as no antiviral treatment has so far demonstrated a clinical benefit in this condition.

In such a context, healthcare professionals assigned to COVID units will be faced with a heavy workload and emotional burden that could lead to psychological suffering or even burnout and its consequences.

We would therefore like to describe, using validated tools, the emotional evolution of the care workers at the Limoges University Hospital and the Esquirol University Hospital faced with this new pandemic infection. An initial and end-of-study evaluation of the caregivers will be carried out concerning their anxiety and depressive state, their personal capacity for resilience and their degree of empathy


Eligibility Criteria:
Inclusion Criteria:

* Health professional working in a COVID unit
* For the qualitative study: 24 participant selected at random to be interviewed

Exclusion Criteria:

* Refusal to participate
PCR Technique to Identify Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus in Nasal and Respiratory Tract Samples

In patients on mechanical ventilation, it is not known whether the identification of S. aureus in LRT samples improves the performance of its nasal detection.

To assess the MSSA or MRSA carrier status of patients requiring mechanical ventilation for more than 48 hours after major heart surgery: comparing the performance of the diagnostic technique Xpert® SA Nasal Complete assay in nasal swab and LRT samples.

Patients undergoing heart surgery require ventilation for more than 48 hours. These patients, placed on mechanical ventilation for a median of 7 days, will be followed weekly until their discharge from hospital. We estimate we will need 500 determinations.

Samples will be obtained according to usual clinical practice. Thus, rather than discarding a sample, it will be subjected to the two laboratory diagnostic techniques (conventional culture and the Xpert® assay). No patient will be subjected to any procedure outside that of routine clinical practice.

Patient with a tracheal tube in whom nasal and LRT secretions can be simultaneously obtained. Patients may also be included if LRT samples can be obtained via a different approach (tracheostomy, fibrobroncoscopy etc.).

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years)
* Signed Informed consent
* Patient admitted to the HS-ICU before or after undergoing heart surgery
* Patient on mechanical ventilation for \>2 calendar days on the date of event (suspicion of LRT infection) ), taking the day of ventilator placement as day 1
* Patient with a tracheal tube in whom nasal and LRT secretions can be simultaneously obtained. Patients may also be included if LRT samples can be obtained via a different approach (tracheostomy, fibrobroncoscopy etc.).
A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)

The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.

The primary objective of this study is to determine the activity of OSI-461 given twice daily orally in previously untreated CLL patients. The secondary objective is to evaluate the safety profile of OSI-461 in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood.
* No previous therapy for CLL.
* Expected remaining life span greater than or equal to six months.
* 18 years or older.
* Willingness and ability to sign an informed consent.

Exclusion Criteria:

* Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
* History of other malignancy which could affect the diagnosis or assessment of OSI-461.
* Previous therapy for CLL.
* Use of an investigational medication or device within one month of initiating study therapy.
* Concurrent immunotherapy.
* Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study).
* Any condition or any medication which may interfere with the conduct of the study.
* Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
* Evidence of CNS involvement.
* Pregnant or nursing women.
Application and Revision of Montreal Cognitive Assessment in Chinese Retirees

The study was designed to employ MOCA to screen mild cognitive impairment (MCI) in military retirees and to analyze the associated risk factors. As such, MOCA was revised to be validated for the Chinese context.

Three hundred and four retired military cadres were investigated using a random cluster sampling technique including personal information, prevalence, MOCA scale, and related neuropsychiatry scale. Thirty retirees were random chosen and tested again with the revised MOCA scale one month later.

Eligibility Criteria:
Inclusion Criteria:

* aged \>=60 years old retired military cadres lived in Xian,Shaanxi,China questionnaires completed

Exclusion Criteria:

* deaf-mute
The Evolution and Management of Migraine Recurrence Beyond 24 Hours

What is the course of migraine headache recurrence, how is it managed, what characteristics are associated with it, and how does it influence patient satisfaction with treatment?


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients at University Headache Center with \> 6 month diagnosis of migraine with and/or without aura (ICHD-II)
* Greater than or equal to 18 years old

Exclusion Criteria:

* Greater than 15 days/month total headache days
* Analgesic use greater than 15 days/month (other than aspirin less than or equal to 325mg/d)
Open-Label,Non-Randomized Trial of Cisplatin Chemotherapy in BRCA1-Positive Metastatic Breast Cancer Patients

Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical issue. There are emerging data which suggest that mutation carriers may respond differently than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary cancers for a range of pathologic and molecular factors, including tumor grade and histologic appearance. Several studies have shown that the response to treatment for women with a BRCA1-associated breast cancer reflects the underlying tumor biology, in particular, the impairment of the DNA damage response and repair pathways, and that it is possible to exploit the sensitivity of BRCA1-associated cancers to DNA damage.

It is equally important that the investigators evaluate the benefit of cisplatin in women with disseminated breast cancer, including those who have previously been treated with one or more chemotherapy regimens. This study is undertaken to evaluate the efficacy of cisplatin chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary objective is to determine the objective response rate of cisplatin in BRCA1 carriers with metastatic breast cancer. The secondary objectives are to determine 3-year survival and to evaluate the toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged ≥ 18 years, with measurable (defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (14)) metastatic (stage IV) breast cancer, and who are known to carry a BRCA1 mutation, are eligible.
* In addition, the following are required:

  * adequate hematologic
  * renal, and hepatic function
  * adequate recovery from recent surgery and/or radiation therapy
  * recovery from all prior treatment-related toxicities (to grade \< 2 according to National Cancer Institute Common Toxicity Criteria, Version3.0, except alopecia)
  * life expectancy of at least 12 weeks
  * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. -
* Patients could have received up to four prior chemotherapies for metastatic disease.

Exclusion Criteria:

* Patients with known brain metastases are not eligible.
* Patients previously treated with a platinum-based chemotherapy are not eligible.
Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)

The purpose of this study is to test a specific nerve stimulation protocol as therapeutic option in patients diagnosed with CRPS (complex regional pain syndrome) of the upper extremity.

A specific high frequency electric stimulation is conveyed at 5 days to the affected hand. Each stimulation session lasts 45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CRPS Type I

Exclusion Criteria:

* intolerable hyperalgesia
* lesions at the fingertips
* high grade digit contracture
* central neurologic disorders
* psychiatric disorders