cyrilzakka/clinical-trials huggingface dataset:
Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT

Purpose of this study is to determine the incidence of deep venous thrombosis after partial knee replacement.

Doppler Ultrasound will be performed 2-6 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral partial knee replacement
* Postoperative anticoagulation with aspirin 325 twice daily
* Regional anesthesia
* Inflatable garments worn during hospitalization

Exclusion Criteria:

-Bilateral partial knee replacement
Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life

The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), antibiotic exposure, GERD medication exposure.

Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay through the first year of life. Investigators will perform statistical analyses to test the hypotheses (1) that there is an association between the developing oral and gut microbiomes, and (2) that they interact in affecting childhood obesity.

This study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring oral and gut microbiome collected from that study's second born participants.

Eligibility Criteria:
Inclusion Criteria:

1. full-term infant (\> 36 0/7 weeks gestational age) without significant morbidity
2. nursery/NICU/maternity stay of 7 days or less
3. participant children can be (but do not have to be) twins
4. English speaking mother
5. care provided at an HMC affiliated clinic
6. a working telephone number

Exclusion Criteria:

1. prenatal ultrasound presence of intrauterine growth retardation (IUGR)
2. infant birth weight \<2250 grams
3. presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
4. any major maternal morbidities and/or pre-existing condition that would affect postpartum care or her ability to care for her newborn such as cancer, multiple sclerosis, lupus, etc.
5. plan for newborn to be adopted
6. plan to move from Central Pennsylvania within 1 year
7. have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)
Search of Protein Biomarkers in Order to Achieve a Molecular Classification of Gliomas

The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI). In order to provide more specific informations for the diagnosis and the prognosis of high grade glioma.


Eligibility Criteria:
Main inclusion criteria:

* Patients with grade III or IV glioma newly diagnosed with histological evidence
* Surgical indication
* Tumor tissue available at biobank of Lille
* Men and women aged ≥ 18 years
* Informed Consent signed by the patient or his legal representative.

Main exclusion criteria:

* Antecedents of other cancers except basal cell skin cancer or carcinoma in situ of the uterus cervix
* Previous history of brain radiotherapy
* Anti-tumor systemic treatments (chemotherapy or targeted therapy) prior to surgery of glioma
* Genetic disease that may cause brain tumor, potentially radiation-induced tumor
* History of degenerative neurological disease prior to diagnosis
* contraindication to MRI
Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)

To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.

This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine weeks for each subject. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects must be at least greater than or equal to 35 years of age at the time of consent.
* Subjects must have a pre-established primary clinical diagnosis of COPD.
* Subjects must have a baseline FEV1 less than or equal to 65%
* Subjects must have a predicted and \>0.70 Liter
* subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days
* Subjects must have a FEV1/forced vital capacity (FVC) less than or equal to 70%
* Subjects must have a greater than or equal to 15 pack-year smoking history
* Subjects must have a baseline medical research council (MRC) dyspnea scale score greater than or equal to 2
* Regular use of a prescribed therapy for control of COPD symptoms for 3 months prior to study entry.
* No COPD exacerbations that have required an emergency room visit, hospital admission or intensive out-patient therapy within 1 month prior to study entry

Exclusion Criteria:

* Females who are pregnant or lactating.
* Concurrent requirement of oxygen therapy
* Known history of asthma, or any chronic respiratory disease other than COPD (not including chronic bronchitis or emphysema).
* Diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer.
* Lung resection of more than one full lobe.
* Use of intravenous, intra-articular or intramuscular corticosteroids within 30 days of study entry
* History of upper or lower respiratory infection within 14 days of study entry.
* Participation in an investigational drug study within 30 days of study entry.
The Effects of Sacubitril/Valsartan on the Heart Functions

Background:

Sacubitril/valsartan, has been found to be more beneficial than enalapril for reducing the incidences of sudden cardiac death, death from worsening heart failure (HF), and hospitalization. However, there is no prospective echocardiographic data describing the effects of sacubitril/valsartan on the heart functions and left ventricular (LV) reverse remodeling. Therefore, the aim of our study was to evaluate the effects of sacubitril/valsartan on the LV functions using two dimensional (2D), three dimensional (3D) echocardiography and the 3D strain parameters.

Methods:

In 100 patients with HF with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled. The basal 2D and 3D echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age is more than or equal 18 years old
* Able to provide written informed consent
* Indicated for the use of sacubitril/valsartan as recommended by the European Society of Cardiology (ESC) heart failure guidelines 2016
* Left ventricular ejection fraction of 40% or less

Exclusion Criteria:

* Cardiac resynchronization therapy (CRT) device implantation less than 3 months prior to the start of this study or CRT implantation intentions
* Atrial fibrillation
* Poor echocardiographic images
* Sacubitril/valsartan treatment intolerance during the follow-up period
Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients

AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

* Advanced myeloma, with measurable disease as defined in the protocol.
* Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products.
* Able to perform the activities of daily living.
* Off prior therapy for at least 2-4 weeks depending on the drug.
* Blood counts and blood chemistries in or near normal range.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted.
* Prior radiation is permitted.

Exclusion Criteria:

* Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.

In this retrospective research results of ACL reconstruction in adolescent will be evaluated. As we know ACL ruptures become more frequent and more often operated these days. According to literature the results in patients younger than 20 years old are worse. Therefore clinical and MRI evaluation will be performed. The aim of the study is to assess subjective and objective functional outcome of ACL reconstruction with follow-up at least 3 years. MRI scans will be evaluated to highlight any early signs of osteoarthritis and describe graft morphology. IKDC, KOOS scales will be utilised for subjective evaluation. Clinical tests such as Lachman's, pivot shift, Appley's along with anterior tibial shift measurement with digital arthrometer for objective assessment will be also performed. Additionally isokinetic tests will be performed in two speeds of 60 and 180 deg/s. Most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured .

Preliminary group of patients consists of 150 cases with follow-up at least 3 years, operated in age 12-17 years. All cases available for the study will be assessed with methodology above. Dedicated statistical test will be utilised to evaluate the results.


Eligibility Criteria:
Inclusion Criteria:

* age between 10-17 years at time of surgery
* ACL full thickness lesion
* meniscal lesions repaired simultaneously
* completed research protocol

Exclusion Criteria:

* age \<10 yo and \>17 yo.
* PCL concomitant injury
* polytrauma
* other same knee surgeries performed before intervention
The INSPIRE-ASP PNA Trial

The INSPIRE-ASP PNA trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with PNA is infected with a resistant pathogen.

Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.


Eligibility Criteria:
Facility Inclusion Criteria:

* HCA hospitals admitting adults with PNA
* Facility use of MEDITECH as their electronic health record system

Facility Exclusion Criteria:

-

Note: unit of randomization is the hospital, however the CPOE alert intervention will calculate risk estimates for adults age \>=18 admitted to non-ICU wards and who are ordered to receive extended-spectrum antibiotics for PNA. Prisoners were excluded from prompts and analysis.
Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients

The goal of this clinical trial is to learn about the mutation spectrum of homologous recombination repair pathway genes and its instructive significance in the treatment of Chinese breast cancer patients.

The main questions it aims to answer are:

1. What is the mutation spectrum of homologous recombination repair pathway genes in Chinese breast cancer patients?
2. Does homologous recombination repair pathway gene mutation have an impact on patient outcome (breast cancer recurrence, neoadjuvant chemotherapy efficacy, treatment decisions, etc.) ? There is no intervention on participants, but all participants will be given regular follow-up post surgery according to ASCO guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. Pathology-confirmed breast cancer patients who meet at least one of the criteria below:

   * Triple-negative breast cancer
   * Age ≤ 50 years
   * Male breast cancer
   * With personal or family history of malignancy: breast cancer, ovarian cancer, prostate cancer, pancreatic cancer, other malignancies
   * HER-2 negative recurrent or metastatic breast cancer
   * HER-2 negative high-risk breast cancer:

   A: Neoadjuvant phase: non-pathological complete response for triple-negative breast cancer; non-pathological complete response AND CPS+EG score ≥ 3 for hormone receptor positive breast cancer B: Adjuvant phase: ≥ pT2 or ≥ pN1 for triple-negative breast cancer; ≥ 4 lymph node metastasis for hormone receptor positive breast cancer
2. Having been or intended to be tested for germline and (or) somatic homologous recombination repair gene mutations
3. Consent to providing medical charts and homologous recombination repair gene testing results, and being cooperative for long-term follow-up

Exclusion Criteria:

1. Homologous recombination repair gene testing results unavailable
2. Other factors deemed by the investigators that may sabotage the study
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)

The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated triglyceride (TG) levels.


Eligibility Criteria:
Inclusion criteria:

* LMT ineligible
* Participants must meet the lipid criteria of "low to moderate CHD risk" as defined by National Cholesterol Education Program Adult Treatment Panel III Framingham Point Scores (NCEP ATP III)
* HDL-C \<40 mg/dL (1.03 mmol/L) in males and \<50 mg/dL (1.29 mmol/L) in females
* Triglyceride (TG) level \<300 mg/dL (3.39 mmol/L).
* Fasting serum glucose (FSG) at Visit 1 AND Visit 2 \<126 mg/dL (\<7 mmol/L)
* Hemoglobin A1c (HbA1c) level \<6.5%
* Participant willing to use acceptable method of contraception during the study, including the 14-day follow-up period

Exclusion criteria:

* History of malignancy ≤5 years prior to signing informed consent, except for adequately-treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Participation in a study with an investigational compound (non-lipid-modifying) within 30 days
* Pregnant, breastfeeding, or expecting to conceive, or father a child during the study, including the 14-day follow-up period
* Consumption of more than 3 alcoholic drinks on any given day or more than 14 drinks per week
* Engages in or plans to engage in vigorous exercise or an aggressive diet regimen during the study
* Diabetes mellitus, based on medical history, FSG ≥126 mg/dL (7 mmol/L), and HbA1c ≥6.5%
* Risk factors for coronary heart disease
* Active or chronic hepatobiliary or hepatic disease
* Active peptic ulcer disease within 3 months of Visit 1
* History of hypersensitivity or allergic reaction to niacin or niacin-containing products
* Episode of gout within 1 year of Visit 1, unless currently stable on allopurinol
* Taking an LMT (including statins, bile acid sequestrants, fibrates and niacin \>50 mg as monotherapy or coadministered with other LMTs)
* Use of over-the- counter or traditional medicine (e.g. red yeast rice products) for lipid-lowering
* Receiving treatment with systemic corticosteroids (unless on stable therapy for at lest 6 weeks for replacement for pituitary/adrenal/hypogonadal disease)
* Uncontrolled illness or infection
A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients

To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as lung or gynecological cancer
* patients receiving platinum containing chemotherapy
* written informed consent
* hemoglobin concentration less than 11 d/dL at enrollment
* life expectancy of more than 4 months

Exclusion Criteria:

* hemolysis, gastrointestinal bleeding, postoperative bleeding
* iron deficiency
* megaloblastic anemia
* any primary hematological disorder that could cause anemia
* received \> 2 RBC transfusions with 4 weeks or any RBC transfusion within 2 weeks before randomization
* prior treatment with KRN321
* received erythropoetin therapy within 8 weeks before treatment
Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery

The goal of this clinical trial is to evaluate the usability of the Haermonics Pure system in patients undergoing a cardiac surgery procedure with the use of cardiopulmonary bypass.

All measurements and interventions are standard of care, except pericardial flushing with the Haermonics Pure system.

This is a prospective, single-arm, single-center clinical investigation of adult patients undergoing cardiac surgery. Safety and efficacy of CPPF, with and without the device, has been established in comparison with standard drainage. Therefore, this study is designed primarily to establish the usability of the device and its accessories, not requiring randomization against a control group.

Because the Haermonics Pure system and its accessories are used directly after surgery for several hours up to several days until drain removal before being discharged from the hospital, it is sufficient to follow patients until discharge from the cardiac surgery department. For patients with a prolonged hospitalization because of postoperative complications, it is considered sufficient to follow patients for 2 weeks after surgery because the impact of a pericardial flushing and postoperative drainage on outcomes is critical within the immediate postoperative period but limited beyond the time that the drains are removed. For device-related adverse events, follow-up will continue until the event is considered resolved or the patient is discharged.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥18yrs and weight ≥40kg) undergoing cardiothoracic surgery (CABG and/or valve surgery, elective aortic surgery, Bentall procedure, ascending aorto/aortic arch replacement) with the use of cardiopulmonary bypass
2. Patient has been informed of the nature of the clinical investigation and is willing and able to give written informed consent for investigation participation

Exclusion Criteria:

1. Euroscore II \&gt; 20%
2. Emergent procedures
3. Complication during surgery which is life threatening and/or requires another surgical intervention
4. Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)
5. Thoraco-abdominal surgery, or intraoperative injury to the diaphragm leading to an open connection between the thoracic and abdominal cavity
6. Participation in any study involving an investigational drug or device
7. Patient is pregnant or nursing
8. Inability to understand study information
Inspiratory Muscle Training and Asthma

This is a pilot study which will assess the feasibility of a follow on main study. This study will examine the impact of inspiratory muscle training on quality of life, rescue drug medication usage, and other markers of asthma in adult asthmatics in the UK.


Eligibility Criteria:
Inclusion Criteria:

* Asthma Control Questionnaire score of ≥ 1.5
* 10 mg or less of prednisolone (or equivalent) daily
* Aged 18 to 59 years inclusive
* Able to provide written informed consent

Exclusion Criteria:

* Any significant heart or lung disease other than asthma including any previous history of pneumothorax
* Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease) not controlled with treatment, making implementation of the protocol or interpretation of the study results difficult
* Women who are pregnant
* Forced expiratory volume in one second of less than 50% best or predicted
* A history of smoking 20 cigarettes a day for 20 years or more (or an equivalent amount)
* Undertaken a structured program of inspiratory muscle training within the past three months
* Currently a participant in another interventional study
KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain

We assessed the effects of the N Methyl aspartate receptor antagonist Ketamine on long-term post thoracotomy pain. We hypothesized that ketamine could prevent supersensitization of the central nervous system involved in this chronic neuropathic pain.

In this clinical, randomized prospective study, peri operative administration of ketamine was compared to placebo on long term post thoracotomy pain after a 2 months follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for thoracotomy or pneumectomy

Exclusion Criteria:

-
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>=18 to \<= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to \< 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
* Diagnosis of CD for at least 3 months prior to Baseline.
* Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD.
* If female, participant must meet the contraception recommendations.

Exclusion Criteria:

* Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.
* Prior exposure to p19 inhibitors (e.g., risankizumab).
* Complications of Crohn's disease.
* Having an ostomy or ileoanal pouch.
* Known active Coronavirus Disease 2019 (COVID-19) infection.