cyrilzakka/clinical-trials huggingface dataset:
An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice

This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.

This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age ≥ 18 yrs),
* Diagnosed with multiple myeloma (measurable or not),
* In whom pomalidomide treatment was first initiated between October 1, 2014, and September 30, 2019,
* Patient already included in the Imnovid registry,
* Having received oral and written information about the study, and having given their consent to participate.

Exclusion Criteria:

* Previous participation in a clinical trial with pomalidomide,
* Treatment with pomalidomide in a previous line,
* Simultaneous participation in a clinical trial.
Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.

Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.

All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.

Exclusion Criteria:

* \<18 years old
* Pregnant women
* Kidney-pancreas transplantation
* Double J stent catheterization at the momento of randomization
* Permanent vesical catheter
Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer

This is an expanded access program for eligible participants designed to provide access to onvansertib in combination with FOLFIRI and bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Participant is NOT eligible for other clinical trials currently open in the region
* Participant has failed or progressed on standard of care systemic therapy
* FOLFIRI (with or without 5FU bolus and continuous infusion)/bevacizumab plus onvansertib is appropriate for the participant as determined by the treating physician, including participants who have previously been treated with FOLFIRI
* Histologically confirmed metastatic and unresectable CRC with a confirmed KRAS mutation
* Age ≥ 18 years
* Participant was previously enrolled in an existing Cardiff clinical trial that is ending and based on investigator judgement has responded to treatment using onvansertib plus FOLFIRI (with or without 5FU bolus) + bevacizumab

Women of Child-bearing Potential

* Women of child-bearing potential (WOCBP) must agree to use method(s) of contraception
* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of onvansertib treatment
* If sexually active, the participant must agree to use contraception considered adequate and appropriate by the treating physician during the period of onvansertib administration

Exclusion Criteria:

* Participant has not recovered from minor or major surgery and less than 6 weeks out from major surgery
* Participant has active Hepatitis B or C infection
* Participant has a known history of testing positive for human immunodeficiency virus or having been diagnosed with acquired immunodeficiency syndrome
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure Class II or higher according to the New York Heart Association Functional Classification, unstable angina pectoris, significant pulmonary disease (shortness of breath at rest or mild exertion), that would limit compliance with study requirements
* Abnormal glucuronidation of bilirubin, known Gilbert's syndrome
* Participants with any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the treating physician, would substantially increase risk to their well-being
* Any condition that, in the opinion of the treating physician, would substantially increase risk to their well-being
TENS Unit To Decrease Pain After Laminaria Insertion

The purpose of the study is to learn more about the transcutaneous nerve stimulation (TENS) unit, an over-the-counter option for pain relief that is not a medication. The investigators are hoping to find out if this device decreases pain during and after laminaria placement for patients undergoing both elective and medically indicated second-trimester termination of pregnancy.

To compare the maximum pain scores reported during the interval between osmotic dilator placement and D\&E procedure of patients receiving the standard of care plus sham placebo and those who use an adjunctive Transcutaneous electrical nerve stimulation (TENS) unit in addition to standard of care.

Secondary objectives include comparing pain scores at the time of laminaria insertion, assessing the number and duration of TENS sessions, additional analgesic use, satisfaction with pain management, and patient perception of the ease of use of the TENS unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laminaria insertion for D\&amp;E procedure
* Age 18 years or older
* Capability and willingness to send and receive SMS messages by phone and complete web-based surveys
* Capability to read and understand directions for using a TENS unit
* Capability to operate a TENS unit according to provided directions

Exclusion Criteria:

* Inability to complete the informed consent in English
* Exposure to adjunctive pharmacologic cervical preparation (misoprostol or mifepristone) within 48 hours of the D\&amp;E procedure
* Contraindication to ibuprofen or bupivacaine
* Contraindication to TENS, including cardiac pacemakers, epilepsy, bleeding disorders, cancer, and concurrent use near transdermal drug delivery systems
* Previous participation in this trial
* Prior use of TENS unit
Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA)

To develop a database of medical information about patients with MLA in an effort to increase our understanding of the characteristics of MLA, which is the rarest form of endometrial carcinoma.

Primary Objectives

1. To collect, both prospectively and retrospectively, data on participants characteristics, disease characterization, pathology and molecular data, treatment, and outcomes for participants with gynecologic mesonephric-like adenocarcinoma (MLA).

Secondary Objectives

1. To organize clinical information to support multifaceted queries of participant characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with participant outcome.
2. To have a single data repository kept on a secure platform that will integrate clinical information and research findings and serve as an archive for future research.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with a diagnosis of gynecologic mesonephric-like adenocarcinoma (MLA).
2. Patients can also be diagnosed with mesonephric adenocarcinoma (MA) or patients with mesonephric and mesonephric-like carcinosarcomas.
3. Patients who are receiving or have received treatment at any facility, including but not limited to MD Anderson Cancer Center are eligible.
4. Patients may be residents of any country and be of any ethnic background.
5. Patients who request to participate in the registry, regardless of the method by which they learned of it, are eligible to participate.
6. Patients who do not speak English can be eligible if accompanied by an institutional interpreter.

Exclusion Criteria:

1. Patients with other subtypes of EACs.
Evaluation of Patients With Vena Cava Inferior Thrombosis

The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in terms of etiology, clinical course and prognosis during long-term follow-up. Patients with isolated lower extremity DVT, matched for age and gender, serve as controls.

All Patients are assessed using a standardized questionnaire and details concerning VTE risk factors, concomitant disease, medical conditions, diagnosis and therapy of IVC thrombosis were registered. A blood sample is taken to test for inherited and acquired thrombophilia. In addition, duplex ultrasound examination and digital photoplethysmograph are performed to assess postthrombotic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* age 18-90 years

Exclusion Criteria:

* none
A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly

This study compares the results of the existing fibrinolysis monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients.

Ultrasound-based viscoelastic hemostasis analysis is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms.

The novel viscoelastic hemostasis analysis uses ultrasound guided waves to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis, which will be an assay of hyperfibrinolysis for critically ill patients.

This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional viscoelastic testing methods.

Eligibility Criteria:
PART 1

Inclusion Criteria:

Subject is scheduled for surgery with general surgery Subject is 18 years or order Subject requires routine TEG measurement

Exclusion Criteria:

Subject with coagulation and fibrinolysis exceeding normal values based on laboratory tests (including prothrombin time, international normalized ratio, activated partial thromboplastin time, plasma fibrinogen concentration, D-dimer, platelet count, hemoglobin concentration, and hematocrit) Subject with any abnormal parameters detected by TEG Subject with a history of bleeding and thrombosis Subject who has taken any medications that may affect coagulation, platelet aggregation, or fibrinolysis within the past 10 days (including non-steroidal anti-inflammatory drugs and aspirin) Residual blood volume \<1ml

PART 2

Inclusion Criteria:

Subject is scheduled for surgery with general surgery Subject is 18 years or order Subject Subjects with detected hyperfibrinolysis (LY30\>8%) or non-hyperfibrinolysis(LY30≤8%) based on TEG.

Exclusion Criteria:

Residual blood volume \<1ml
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.

Eligibility Criteria:
Inclusion Criteria:

* • Subject signed inform consent

  * Age \> 18 years
  * Not pregnant or breast feeding
  * Patient capable of undergoing anesthesia
  * Patient selected to undergo Whipple procedure or distal pancreatectomy
  * Patient does not have metastatic disease
  * Patients will have close margins
  * No prior radiation therapy to the region for separate cancer
  * Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
  * Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
  * Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
  * Gemcitabine + nb-paclitaxel
  * FOLFIRINOX
  * Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
  * up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil

Exclusion Criteria:

* Not surgical candidate
* Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
* An IRE candidate (IRE is Percutaneous irreversible electroporation)
* Recurrent or previously resected tumors
* Documented History of Alcoholism and or drug abuse
* Participant in other clinical trials
Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients with Estrogen-Positive Breast Cancer Over Age 65

This study will examine the outcomes of lumpectomy, surgery to remove a tumor, without sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative breast cancer. Clinically node-negative means that during a physical exam your doctor cannot feel or see that any lymph nodes near the breast area are swollen and there is also no imaging evidence, such as from a mammogram, of nodal involvement.

The primary objective of the study is to determine whether omission of sentinel node biopsy in patients who meet eligibility criteria results in an acceptable regional recurrence rate over a 6-year period. A regional recurrence is defined as any recurrence in the ipsilateral axillary nodes, supraclavicular nodes or internal mammary nodes.

Eligible patients will undergo standard of care lumpectomy without sentinel node biopsy followed by radiation and hormonal therapy or have already undergone the procedure prior to enrollment in the study. She may also receive chemotherapy as determined by her treating physician. A physical examination of the affected breast and regional lymph nodes will be conducted every six months for the first two years of follow up and then yearly for the last 3 years of follow up. Imaging of the affected breast will occur every 12 months after surgery per standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Female age 65 and older
* Staging:

  1. Patients enrolled prior to surgery: Diagnosis of clinical T1-2N0, ER+, HER2-negative, invasive breast cancer as determined by treating physician. DCIS or LCIS may be present with invasive cancer.
  2. Patients enrolled after surgery: pT1-2NX, or pT1-2N0, ER+, HER2-negative, invasive breast cancer. DCIS or LCIS may be present with invasive cancer.
* Plan to undergo lumpectomy within 3 months of study registration, or underwent lumpectomy within 60 days of study registration (without sentinel node biopsy)
* Patients in whom lymph nodes are palpable and not suspicious who are found to be nodal tumor-free by nodal core needle biopsy are permitted, but those with biopsy-proven nodal metastases are excluded

Exclusion Criteria:

* Patients with diagnosis of ductal or lobular carcinoma in situ
* Patients with diagnosis of inflammatory breast cancer
* Patients who have undergone neoadjuvant chemotherapy for current primary breast cancer (past treatments for other cancers are acceptable)
* Patients planning to have mastectomy or had a mastectomy of the ipsilateral breast
* Prior history of ipsilateral (invasive or DCIS) breast cancer
* Diagnosis of clinical T3 or T4 breast cancer
Efficiency of Home-Based Pulmonary Rehabilitation in Adults With Asthma

Asthma is a serious global health problem affecting people of all ages in every country in the world. Despite the presence of effective medications, many studies have reported poor asthma control in patients. Therefore, new approaches are needed to improve asthma control. Pulmonary rehabilitation is recommended as an alternative approach in patients with chronic lung disease including asthma. Also, home-based type of pulmonary rehabilitation can be preferred because it is more cost-effective and patients can spend more time with their families. There are a limited number of studies in the literature evaluating the efficacy of home-based pulmonary rehabilitation in asthmatic patients. The aim of this study was to investigate the efficacy of home-based pulmonary rehabilitation program with simple equipment in asthmatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with asthma
* Acceptance of persons to participate in the study
* Being in the 18-65 age range

Exclusion Criteria:

* Presence of an orthopedic, neurological, systemic disease that prevents the exercise
* Having mental, communicative and behavioral disorders that may cause problems in understanding commands and questions or practicing exercises.
* Exercising 3 or more days a week
The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination

This study was carried out to determine the effect of listening to music and acupressure application in reducing pain and anxiety during gynecological examination.


Eligibility Criteria:
Inclusion Criteria:

* - not to be pregnant,
* no hearing problems
* Being between the ages of 19 and 65, Not having any psychiatric illness,
* No gynecological cancer, Not to have any deformity in her extremities

Exclusion Criteria:

-
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol

The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving (raising) low levels of "good cholesterol", high-density lipoprotein cholesterol (HDLc), as compared to placebo.

A multicentre, two-staged with interim analysis, parallel, randomised, double blind, placebo-controlled, dose-ranging study of the safety, tolerability, and effects on plasma high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10mg daily doses of GW501516 in subjects with low HDLc

Eligibility Criteria:
Inclusion criteria:

* Have a fasting plasma HDLc concentration \<=45mg/dL (\<=1.16mmol/L), plasma LDLc levels that do not require treatment according to the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPÂ III) guidelines.
* Have a fasting plasma TG concentration =500mg/dL (=5.65mmol/L).

Exclusion criteria:

* Coronary heart disease.
* Diabetes mellitus.
* Atherosclerotic disease.
Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep

The main purpose of this study is to learn about the influence of two different behavioral interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the mechanisms involved. There is research evidence that healthy sleep promotes heart-health and may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be influenced by sex. This research will compare two interventions that are each designed to improve sleep health, and will investigate sex differences in response. The project includes 3 in-hospital stays with biological measurements to evaluate the underlying mechanisms associated with the effectiveness of two different blood pressure lowering behavioral interventions.

The study involves home-based sleep-wake data collection before and during behavioral intervention, and 3 overnight stays in the hospital. For each hospital stay participants will be asked to arrive in the afternoon, and stay until the next evening. They will be provided dinner on the first day and breakfast, lunch and dinner on the second day. If they are taking any blood pressure medication they will continue to take it through the study. During the in-hospital stays, blood pressure will be measured continuously using two small finger cuffs. In order to monitor and record brain waves to determine sleep and wakefulness, small gold-coated disks called electrodes will be placed on the head and body. Heart rate, blood pressure and brain activity will be recorded for a little over 24 hours on each in-hospital stay. Before as well as during the in-hospital stays questions will be asked about sleep times, subjective sleepiness and other indices relating to well-being.

Eligibility Criteria:
Inclusion Criteria:

* pre-hypertension or stage one hypertension (BP ≥120/80 and \<160/100).
* usual sleep period occurs at night

Exclusion Criteria:

* significant active or uncontrolled sleep disorders
* shiftwork
* current pregnancy
* diabetic patients who are insulin dependent (or have HbA1c\>9.0%)
* current use of hypnotics or clonidine
* renal/electrolyte disorders and any other condition that the study screening physician considers would significantly impede participation in the study
Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease

The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation

Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.

This multi-center observational study of IFI in high risk hematological patients, the study will investigate the epidemiology of IFI, describe antifungal strategy, proportion of antifungal prophylaxis, empiric therapy, pre-emptive therapy and targeted therapy in at-risk patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy
* All newly allogeneic or autologous transplant recipients during the study period