cyrilzakka/clinical-trials huggingface dataset:
Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography and MRI

To determine the sensitivity, specificity, and accuracy of preoperative ultrasound, elastography, mammography and breast MRI in women with dense breast tissue diagnosed with breast cancer; to test whether elastography or MRI can improve upon routine mammogram and conventional ultrasound in women with dense breast tissue.


Eligibility Criteria:
Inclusion Criteria:- Patients must have a suspicious breast lesion detected by a physical exam, mammography or U/S . that has not been surgically resected and is being considered to undergo biopsy if clinically indicated.

* Patients must be \>= 18 and \< 80 years of age, and female.
* Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:- Patients who have already had primary surgical excision of the suspicious finding
* \<18 or \>80 years of age
* Pregnant or Lactating Women
Estimation of the Dietary Requirement for Vitamin D in Ethnic Groups

The aim of this study is to perform a double-blind, randomised, dose-response trial of vitamin D3 supplementation in United Kingdom (UK)-dwelling adults of white European, South Asian, and black African/Caribbean ethnicity to investigate the distribution of dietary intakes needed to maintain adequate vitamin D status in winter, as indicated by serum 25(OH)D concentrations at ranges of \>25 to 50 nmol/L. In addition, this study will investigate the effect of vitamin D3 supplementation on immune health, muscular strength, and overall health.

The aim of this study is to perform a double-blind, randomised, dose-response trial of vitamin D3 supplementation in United Kingdom (UK)-dwelling adults of white European, South Asian, and black African/Caribbean ethnicity to investigate the distribution of dietary intakes needed to maintain adequate vitamin D status in winter, as indicated by serum 25(OH)D concentrations at ranges of \>25 to 50 nmol/L. In addition, this study will investigate the effect of vitamin D3 supplementation on immune health, muscular strength, and overall health. Recruited participants will be randomised to take 400, 1000, or 2000 IU for 12 weeks. Fasting blood samples collected at baseline and 12 weeks will measure biochemical markers of vitamin D status (serum 25(OH)D, calcium, parathyroid hormone, albumin), lipid profile, ferritin, micronutrient status, and immune and inflammatory biomarkers. Muscular strength will be measured using sit-to-stand and grip strength tests. Questionnaires, food diaries, and dosimeters will be used to gather data on lifestyle, physical activity, dietary intake, and sun exposure.

Eligibility Criteria:
Inclusion Criteria:

* British white European, black African/Caribbean, or South Asian (self-reported)
* Living in England for \>2 months
* Aged \>18 years
* No significant health issues
* English or Urdu speaker

Exclusion Criteria:

* Medical condition or history which might impact study measurements (e.g., ischaemic heart disease, type 1 and type 2 diabetes, thyroid disease, osteoporosis, haematological disease, malignancy)
* Medications known to affect vitamin D metabolism (i.e., hormone replacement therapy, anti-oestrogens treatment, antiepileptic drugs, and breast cancer treatment)
* Pregnant or planning pregnancy during the study period
* Regular use of sun beds
* Having a sun holiday one month prior to commencing study or plans for a sun holiday within the study period. A sun holiday is generally defined as a holiday in a sunny resort outside of the UK. The researchers will assess this on a case-by-case basis depending on the time of year and expected weather conditions
* Reported participation in another clinical trial occurring simultaneously
* Previous intolerance or allergic reaction to vitamin D
Effect of Aerosolised Colistin in Ventilator Associated Pneumonia

the management of Ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR) gram-negative bacilli (GNB) represent a real therapeutic dilemma in intensive care unit (ICU). Colistin remains an effective agent against MDR GNB. However, because of its side effects, mainly nephrotoxicity, other modalities than the intra venous (IV) route should be tried. Several recent data emphasize the interest of inhaled route. The investigators purpose was to evaluate the effectiveness and systemic toxicity of aerosolized colistin in ventilator associated pneumonia.

prospective, randomized, single-blind study comparing two groups of patients treated with aerosolised (AS) colistin versus colistin intravenously (IV). Included were patients who have mechanical ventilation over 48 hours and that have developed a VAP. A VAP was defined as a CPIS (Clinical Pulmonary Infection Score) \>6. Exclusion criteria were septic shock and/or bacteraemia. Included patients were divided into two randomized groups. The 1st received colistin in AS as 4 MU by nebulisation 3 times per 24 h. The 2nd received colistin in IV as a loading dose of 9 MU followed by 4.5MU two times per 24 h. Colistin was given for 14 days or until extubation. Patients were followed for 28 days. Therapeutic efficacy was assessed by a primary outcome: the cure of VAP at day 14 of therapy and defined as resolution of clinical and biological signs of infection that means a CPIS\< 6 and bacteriological eradication. Secondary outcomes: duration of mechanical ventilation, ICU stay-length and mortality at day 28. Systemic toxicity was assessed by the occurrence of acute renal failure (ARF) defined as increase of plasma creatinine more than 1.5 times its base value.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients older than 18 years, with mechanical ventilation during more than 48 hours, and who have presented a Ventilator associated Pneumonia (VAP) defined as a CPIS (Clinical Pulmonary Infection Score) of more than six

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Septic shock
5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.

The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question\[s\] it aims to answer are:

* Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?
* What are the complications associated to the procedure and differences between the two groups.

The present clinical study protocol has the objective to compare the performance of different CeraRoot ceramic implant models (16,11,21,12,14,34,34L) and the different sub-variants (one-piece versus two-piece).

The geographic population of study will be the patients in two different dental centers located in Barcelona (Spain) and Boulder (Colorado, USA). The intended population as described in the device instruction for use (3) is " Intended Population: All fully-grown patients (men or women) requiring dental reconstruction using dental implants and who have no contraindications. The CeraRoot® dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of partial or total edentulism.
* Specially indicated for patients with metal allergies and chronic illness due to metal allergies.

Exclusion Criteria:

1. General Contraindications:

   1. Local and Systemic contraindications for surgery.
   2. Poor oral hygiene
   3. Patients with health problems, disease or any physical or psychological condition to which an oral surgery may be contraindicated.
2. Relative Contraindications:

   1. Previously irradiated bone
   2. diabetes
   3. anticoagulant medication
   4. hemodynamic problems
   5. bruxism
   6. Para functional habits
   7. bad bone anatomy
   8. smokers
   9. none controlled periodontitis
   10. malocclusions
   11. TMJ problems
   12. diseases in the oral cavity
   13. pregnancy
   14. insufficient oral hygiene for adequate health.
3. Local contraindications

   1. insufficient bone quantity or quality
   2. remaining of roots
   3. localized periodontal disease
   4. Any pathology in the neighboring teeth.
Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.

Colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. A previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic, may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut microflora.

The main objective of this study is to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of recurrence of acute diverticulitis and diverticular complications in patients with a recent episode of acute diverticulitis.


Eligibility Criteria:
Key Inclusion Criteria:

* Men and women aged 18-80 years at screening.
* Female participants must be either of non-childbearing potential or of childbearing potential with a negative pregnancy test result at screening and randomization AND agreeing to use a highly effective method of contraception.
* A previous documented episode of diverticulitis between 30 and 180 days prior to screening.
* Clinical remission from acute diverticulitis at screening

Key Exclusion Criteria:

* History of two or more acute diverticulitis episodes or history of any diverticular complication.
* Any documented current organic disease of the gastrointestinal tract other than diverticulosis
* Laboratory signs of clinically significant acute inflammation or signs/symptoms of diverticular complications.
* Diagnosis or history of inflammatory bowel disease (or other conditions associated with ulcerative lesions of the intestinal tract).
* Patients with positive Clostridium difficile toxin stool assay.
* Use of marketed rifaximin (or neomycin or other low-absorbable oral antibiotics) during or after the previous episode of acute diverticulitis.
* Severe hepatic impairment
* Severe kidney impairment
* Any other current significant health condition that in the Investigator's judgement may: i) jeopardize the patient's safe participation in the trial or ii) make unlikely the patient's completion of the study or iii) make unlikely the patient's compliance with the study procedures.
* History of hypersensitivity to rifaximin, rifamycin-derivatives or any of the rifaximin delayed release or placebo excipients.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply
The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

This is a six-month, multicenter, randomized, double blind, parallel-group,placebo controlled study. Patients take Imotun capsules or placebo once a day, between the meals. Patients are allowed to take study drugs during the meal in the case of intolerant reflux of oil smell from GI. If patients do not tolerate the pain, they are able to take Celecoxib as a rescue medication during 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients who aged 40 or more and agreement with written informed consent
* Patients with osteoarthritis according to ACR criteria lasted for the past 3 months or more
* Patients with Kellgren \& Lawrence grade Ⅱ\~Ⅲ on radiographs
* Patients with 40mm or higher 100mm Pain VAS on screening and baseline visit (based on more painful knee)
* Patients with Lequesne's index 5 or more on screening and baseline visit

Exclusion Criteria:

* Patients who had taken SYSADOA within the past 3 months (Imotun, diacerein, s-adenosyl-methionone, JOINS, glucosamine, chondroitin and any other cartilage protective agents determined by investigator)
* Patients who experienced cartilage surgery within the past 5 years or arthroscope surgery within a year(one side or both)
* Patients who were treated with joint space injection within the past 3 months
* Patients who had taken NSAIDs including pain killers within 7 days (except, it is acceptable to enroll the study if the patients have wash out periods at least 7 days before randomization)
* Patients with hypersensitivity or allergy to the study or rescue medicine or those who have medical history.
* Patients with severe liver, kidney or cardiac diseases who are not acceptable for the study determined by investigator
* Patients with active peptic ulcer or GI bleeding.
* Pregnancy, nursing women or women of reproductive age who do not agree to the contraception.
* Patients with abuse of alcohol, illegal drugs or drug dependency
* Patients who were treated with another investigational product within the past 4 weeks
* All other patients who are not acceptable for the study determined by investigator
Dance Study for Post-surgical Pain in Breast Cancer Survivors

The purpose of this study is to examine how a 12-week, virtual dance program may improve pain and quality of life in participants with persistent post-surgical pain, or PPSP, following mastectomy or lumpectomy.

This is a single-arm, Phase 1 study is to assess how a 12-week, virtual dance program may improve persistent post-surgical pain (PPSP) and other participant-reported outcomes of quality of life, fatigue, and body image for breast cancer survivors following mastectomy or lumpectomy.

The study procedures including screening for eligibility and surveys.

Participation in this research study is expected to last up to 16 weeks.

It is expected that about 30 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* History of Stage 0-III invasive breast cancer
* Having undergone lumpectomy or mastectomy
* Moderate to severe persistent post-surgical pain, as defined by pain scores ≥3 on a numerical rating scale (NRS) of 0-10 (10 being the most severe pain) at least 3 months after completion of surgery, chemotherapy, and/or radiation
* Pain scores of 3-4 are categorized as moderate pain; scores of 5-10 are categorized as severe pain26
* Age ≥ 18 years
* Able to read and understand English (to complete required questionnaires and participate in classes)
* Ability to provide informed consent
* Ability to perform seated exercises

Exclusion Criteria:

* Unstable cardiovascular disease in the last 6 months
* Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, untreated substance use disorder, severe personality disorder)
* Metastatic breast or other concurrent cancer
* Pregnant
* Recent history of attending regular dance or similar classes (e.g. yoga or tai chi classes i.e. 20 or more classes in the past 6 months)
* Planned surgery anticipated during the intervention period
* History of a chronic medical condition that has the potential to significantly impact upper extremity function (e.g. stroke, Parkinson's disease, Multiple Sclerosis)
* Currently enrolled in a physical therapy course
* Presence of medical conditions or medications that would prohibit participation in an exercise program
Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients

This is a randomized, open-label, parallel-controlled, multicenter clinical trial in primary hyperuricemia patients with or without gout.


Eligibility Criteria:
Inclusion Criteria:

1. Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
2. Subject who meets one of the following criteria:

   i. History of gout attack: Meeting 2015 ACR/EULAR Gout Classification Criteria and fasting serum uric acid ≥ 480 μmol/L at screening (local laboratory of study site) ii. For asymptomatic hyperuricemia, it is acceptable to meet either of the two criteria:
   1. Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 540 μmol/L (local laboratory of study site);
   2. Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 480 μmol/L (local laboratory of study site), with concomitant primary hypertension or primary hyperlipidemia or type 2 diabetes mellitus, which is treated with a stable dose of antihypertensive or lipid-lowering or hypoglycemic treatment for at least 3 months;
3. At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2;
4. Hematology, Blood chemistry and Urinalysis examination were basically normal.

Exclusion Criteria:

1. Prior intolerance to benzbromarone or contraindication to medication;
2. Secondary hyperuricemia caused by tumor, chronic kidney disease, blood disease or drugs, etc.;
3. Arthropathy caused by arthritis rheumatoid, purulent arthritis, traumatic arthritis, psoriatic arthritis, pseudogout or systemic lupus erythematosus, etc.;
4. Arthropathy caused by chemotherapy, radiotherapy or chronic lead poisoning;
5. Urinary calculi confirmed by B-ultrasound during screening period;
Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014

The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug. The study will also assess the blood levels and action of AZD2014 in the body over a period of time and will indicate whether the drug has an effect on the types of cancer the patients have.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of a solid, malignant tumour that is refractory to standard therapies or for which no standard therapies exist
* At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
* World Health Organisation performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

Exclusion Criteria:

* Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks prior to first dose of study drug
* Patients with abnormal fasting glucose, type I or uncontrolled type II diabetes
* Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions
Long-term Radiographic and Clinic Outcomes of Ulnar Shortening Osteotomy in Patients With Ulnar Impaction Syndrome and Reverse Oblique Sigmoid Notch

Patients with ulnar impingement are often coexisting with patients with distal ulnar and ulnar joints with a type of sigmoid notch, and ulnar shortening surgery is one of the most useful and long-lasting treatments for the treatment of ulnar impingement. Some theories point out that if ulnar shortening surgery is performed on patients with distal oblique ulnar incisional ulnar joints, it may lead to accelerated degeneration of distal ulna and ulna articular joints, resulting in worse wrist function. Some theories have pointed out this Instead, surgery will cause joint remodeling and adaptation, but no long-term studies have confirmed this. Therefore, this study plans to evaluate the long-term radiological and clinical outcomes of ulnar shortening surgery performed on patients with preexisting inverted sigmoid notch to determine whether this surgery will cause accelerated distal degeneration of the phalangeal joints or Reshaping of joints and clinically corresponding changes in results.


Eligibility Criteria:
Inclusion Criteria:

* The distal ulnar joint of the wrist contains a patient with an inverted sigmoid notch of the sacrum, and the ulnar impaction causes ulnar wrist pain. Therefore, the ulnar shortening surgery is accepted.

Exclusion Criteria:

* Patients with diagnosed diseases of immune rheumatism, patients with ischemic necrosis of the carpus, patients with this lesion caused by infection or tumor.
A Study of Enasidenib in People With T-Cell Lymphoma

The researchers are doing this study to find out whether enasidenib is a safe treatment for people with angioimmunoblastic T-cell lymphoma (AITL) that has an IDH2 mutation. The researchers will look at the safety of enasidenib when it is given alone or in combination with the drug rituximab.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically-confirmed AITL at the enrolling institution, with confirmed IDH2 mutation (by MSK ddPCR). For R/R patients, disease must have relapsed or progressed after at least one systemic therapy, diagnostic tumor samples have at least 5% tumor. i) IDH2 hotspot mutation confirmed by CAP/CLIA-certified NGS testing panel. Only cases with confirmed mutations detected \>1% VAF will be eligible.
* Age ≥18 years at time of enrollment Previous systemic anti-cancer therapy for AITL must have been discontinued at least 2 weeks or 5 half-lives (whichever is longer) prior to treatment.

  i) ii) See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant and maintenance therapy for prior malignancy. Patients who have received localized RT as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSKCC Principal Investigator ii) Patients who have received localized RT as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSKCC Principal Investigator iii) Systemic corticosteroids must be tapered to 25 mg/day prednisone (or equivalent) upon start of investigational treatment iv) 4) 5) 6) 7) 8) 9) Topical steroids for treating cutaneous involvement of AITL is permitted Performance status, as assessed in the ECOG grading system, ≤2 Laboratory criteria (use of GCSF and/or blood product transfusions to reach eligibility criteria must be discussed with the MSK PI on a case-by-case basis):

Exclusion Criteria:

-
Collecting Outcomes and Managing Pain After Surgery

The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-90 years old who are undergoing elective orthopedic surgery at Duke Health.
* Patients must have their own smartphone IOS or Android device.
* Patients must be able to read English.

Exclusion Criteria:

* Lacking capacity to provide consent.
* Cannot read English
* Under 18 years of age
* Older than 90 years of age