cyrilzakka/clinical-trials huggingface dataset:
Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease

The aim of this study is to develop a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and Crohn's disease.

Crohn's disease and intestinal tuberculosis mimic each other in clinical, endoscopic, and histological features. In addition, the yield of microbiological/histological test (AFB stain, caseating granuloma) is not high in clinical setting. Therefore, distinguishing CD from ITB especially in highly endemic areas for TB is challenging. The aim of this study is to develop and to validate a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and Crohn's disease

Eligibility Criteria:
Final diagnostic criteria:

* Crohn' disease (at least two of the following is met)

  1. Clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding
  2. Endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease
  3. Radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration
  4. Macroscopic appearance of bowel-wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy
  5. Pathologic findings of transmural inflammation and/or epithelioid granulomas
* Intestinal tuberculosis(at least one of the following is met)

  1. Histologic evidence of caseating granulomas
  2. Histologic demonstration of acid-fast bacilli
  3. Growth of M. tuberculosis on tissue culture
  4. Clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis with proved tuberculosis elsewhere
  5. Response to antituberculous therapy without subsequent recurrence in patients with clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis

Exclusion Criteria:

* Refusal to participate in the study
* Age: 15 years or younger
* Comorbidity with acute infectious disease
* Pregnancy
* Previous history of medication including anti-TB drugs, immunosuppressive drugs, and chemotherapeutic agents\\
* Use of antibiotics within the previous three months
Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia

The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how often it should be taken, and how well people with leukemia tolerate XL228.


Eligibility Criteria:
Inclusion Criteria:

1. The subject has a confirmed pathologic diagnosis as evidenced by the presence of the BCR-Abl translocation \[t(9;22)\] by fluorescence in situ hybridization (FISH), cytogenetics, or quantitative polymerase chain reaction (QPCR) of one of the following:

   1. CML

      * Chronic phase (CP)
      * Accelerated phase (AP)
      * Blast phase (BP) OR
   2. Ph+ ALL
2. The subject has one of the following:

   * Known T315I Abl mutation
   * Known resistance to or intolerance of imatinib and dasatinib
   * At least one prior anti-leukemia therapy, including, but not limited to, interferon, imatinib, or dasatinib
3. The subject is at least 18 years old.
4. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
5. The subject has adequate organ function.
6. The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
7. Sexually active subjects must use an accepted method of contraception during the course of the study.
8. Female subjects of childbearing potential must have a negative pregnancy test at enrollment.

Exclusion Criteria:

1. The subject has received interferon, imatinib, or dasatinib within 7 days of the first dose of XL228.
2. The subject has received an investigational agent or radiotherapy within 28 days of the first dose of XL228.
3. The subject has received immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus for graft-versus-host disease \[GVHD\]) within 28 days prior to the first dose of XL228.
4. The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from toxicities related to peripheral stem cell or bone marrow transplant.
5. The subject has not recovered to CTCAE v3.0 Grade ≤1 from adverse events (AEs) due to investigational drugs or other medications.
6. The subject has known allergy or hypersensitivity to any component of the investigational drug product.
7. The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
8. The subject is pregnant or breastfeeding.
9. The subject is known to be positive for the human immunodeficiency virus (HIV).
10. The subject has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.
Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study.

Evaluation of DOACs treatment on post-extraction bleeding

Consecutive patients requiring at least one dental extraction were enrolled. DOACs regimen was either maintained or suspended. Patients were classified in subgroups depending on the number of teeth extracted per procedure (≤ 3 or \> 3), the need for flap raising and the performance of osteotomy. Bleeding was recorded intraoperatively, perioperatively at 20, 40, 60 and 80 minutes after the procedure, and in the first seven days post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* patients under pharmacological treatment with DOACs
* patients requiring at least one dental extraction
* patients willing to take part in the study and to sign informed consent

Exclusion Criteria:

* patients below 18 years of age
* patients treated with antiplatelet therapy or vitamin K antagonists
* patients presenting with an International Normalized Ratio (INR) \>3.0
* patients suffering from congenital or acquired coagulopathies (e.g. haemophilia, coagulation factors deficiency, von Willebrand disease, thrombocytopenia, cirrhosis)
Effects of Pinitol on Hidrocarbonated Metabolism Parameters in Diabetic, Impaired and Normal Fasting Glucose Subjects

The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism parameters, and evaluate its effect on oxidative stress and endothelial function in diabetic, impaired and normal fasting glucose subjects.

This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design. Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.


Eligibility Criteria:
Inclusion criteria:

* Age range of 18-70 years.
* Normal fasting glucose subjects were diagnosed as fasting glucose \<100 mg/dl and HbA1c \<5.7%.
* Impaired fasting glucose subjects were diagnosed as fasting glucose between 100 and 125 mg/dl and/or HbA1c between 5.7 and 6.4%.
* Type 2 Diabetes subjects were diagnosed as basal plasma glucose ≥ 126 mg/dl, at least twice, or glucose levels 2 hours after 75 g oral glucose overload ≥ 200 mg/dl (American Diabetes Association)

Exclusion criteria:

* Morbid obesity
* Type 1 diabetes
* Heart, liver, thyroid or kidney untreated disease
* Neoplasic disease
* Hypertriglyceridemia (Triglycerides \>400 mg/dl),
* Use of drugs that can influence the inflammatory state or insulin sensitivity (NSAIDs, corticosteroids, antiTNFα) and
* Uncontrolled type 2 diabetes (HbA1c ≥ 8%) or with insulin or intestinal disaccharidase inhibitors (acarbose, miglyol,...) treatment.
Connecting Seniors to Care

The purpose of this study is to assess the feasibility of implementing the virtual assistant devices into the daily routine of participants and their caregivers,to measure social determinants of health,depression,cognitive impairment,nutritional and functional status in the cognitively impaired participants


Eligibility Criteria:
Inclusion Criteria:

* cognitive impairment as reported in the Mental Health Screening/Assessment section on the Interfaith Ministries of Greater Houston's Meals on Wheels Program (IMGH MOW) intake form
* are on the IMGH MOW waiting list
* medically stable

Exclusion Criteria:

* do not have cognitive impairment
* have a pre-diagnosed terminal illness
* unable to ambulate, and/or are unable to use their upper extremities.
Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy

The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine for postoperative analgesia in total abdominal hystrectomy (TAH) operation.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and II
* Planned for elective TAH with a Pfannenstiel incision

Exclusion Criteria:

Patients with the following criteria will be excluded from the study;

* ASA physical status more than II
* Body mass index (BMI)\>35 kg/m2
* Previous abdominal surgeries
* Malignancy
* Individuals with chronic pain
* A history of severe systemic disease
* A pre-existing neurological or psychiatric illness
* Known to be addict on alcohol or drugs
* Known allergy to the study drugs
The Prognostic Impact of Selenium On Critical Surgical Patients

Selenium is an important trace element for human for its multiple roles such as the antioxidant activity. Previous evidences showed that critically ill patients may benefit from selenium supplement but the dose and results are controversial.

Patients after operations for acute abdomen usually suffer from sepsis and stress. The aim of this study is to investigate the efficacy of selenium replacement in critical patients of acute abdomen, to see the impact on prognosis.

Acute abdomen is a common surgical emergency and is often the result of peritonitis due to an acute inflammatory process within abdominal cavity. Many of the patients with acute abdomen have severe sepsis and are critically ill that require an emergency surgery.

The mortality rate of such patients are high because these patients usually have a profound pathophysiological dysregulation and multiple organ dysfunction. One of the mechanism of is the loss of anti-oxidative capacity of cells that fail to recover from ischemic-reperfusion injury.

Selenium is an important cofactor that participate in the antioxidant activity of glutathione peroxidase reaction. There are evidences that critically ill patients may benefit from selenium supplement by better outcome and less mortality but the dose and results are still heterogenous and inconclusive.

The aim of this study is to investigate the efficacy of selenium replacement in critical patients of acute abdomen, to see if there is a significant impact on prognosis, and to establish a clinical guide in the future.

Eligibility Criteria:
Inclusion Criteria:

* Intensive care unit (ICU) patients receiving abdominal surgeries for acute abdomen
* within 48 hours post-operatively
* stay in ICU for more than 48 hours
* meets sepsis criteria of Sepsis-3 (2016)

Exclusion Criteria:

* liver cirrhosis Child-Pugh score B or C
* breastfeeding or pregnancy
* allergy yo selenium
* vegetative status or irreversible diseases with life-expectancy fewer than 28 days
* End-stage renal disease under dialysis
* Human immunodeficiency virus infection
* neutropenia not due to sepsis (granulocyte \< 1000/mm3)
* Heart failure (New York Heart Association class III-IV) or recent myocardial infarction (within 6 weeks)
* post cardiopulmonary cerebral resuscitation within 4 weeks
* taking immunosuppressants
* receiving anti-cancer therapy
* signed do not resuscitation
* joined other clinical research
Effect of Burosumab on the Inflammatory Profile of Patients With X-linked Hypophosphatemic Rickets FLAM-XLH

X-linked hypophosphataemia (XLH) is a rare genetic disorder associated with increased circulating levels of the hormone FGF23, most commonly through mutation of the PHEX gene. XLH is associated with a wide range of clinical manifestations in children and adults, all of which can impact on their health-related quality of life.

Conventional treatment (or standard of care, SOC) consists of phosphate supplementation and active vitamin D analogues. The management of patients with XLH has been modified in France since 2018 with the authorisation of the anti-FGF23 antibody, burosumab, in paediatrics (and in 2020 in adults).

A propensity for overweight/obesity has recently been demonstrated in these patients. Could extra-skeletal effects of FGF23, in particular on the inflammatory profile of patients, be responsible for these manifestations? Obesity has been associated with inflammation in other populations. In terms of inflammation, there is a close link between FGF23 and inflammation: inflammatory cytokines increase the production of FGF23, which in turn increases inflammation by stimulating the production of inflammatory cytokines. Osteoclastogenesis and inflammation are linked and inflammation has been shown to increase bone resorption.

In a recent study, the investigators showed that osteoclastogenesis was significantly impaired in cells obtained from XLH patients compared with control patients, and that osteoclasts obtained from XLH children showed higher gene expression of inflammatory markers than controls. Interestingly, no difference was observed in circulating monocytic cells between the two patient subgroups, conservative treatment and burosumab, whereas the inflammatory profile at the end of osteoclastic differentiation was reduced in cells derived from patients receiving burosumab.

The aim of this study is therefore to investigate the inflammatory profile of circulating monocytic cells on the day of burosumab injection (D0) and seven days later (peak effect of anti-FGF23).


Eligibility Criteria:
Inclusion Criteria:

* Children and adults with genetically confirmed XLH followed at the Lyon Reference Centre for Rare Calcium, Phosphorus and Magnesium Diseases
* Patients treated with Burosumab
* Patients \>12 kg.
* Patients and parent/guardian who have been informed of the study and who do not object to participate

Exclusion Criteria:

* Patients undergoing treatment with oral corticosteroids, or who have received more than 3 months of corticosteroid therapy in the past.
* Patients who have received or are currently receiving immunosuppressive therapy.
* Patients suffering from an inflammatory disease
* Pregnant or breast-feeding women
* Persons deprived of their liberty by judicial or administrative decision
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Durvalumab Long-Term Safety and Efficacy Study

The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.

This is a multicenter, open-label, global study that will enroll patients who are currently receiving durvalumab monotherapy, or have previously received durvalumab as monotherapy or in combination with any other approved or investigational anticancer agents, in an eligible AstraZeneca/MedImmune-sponsored clinical study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be 18 years or older, at the time of signing the ICF. For subjects aged \< 20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative.
2. Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study.
3. Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen).
4. Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.

Exclusion Criteria:

The following exclusion criteria apply only to patients receiving treatment or retreatment:

1. Currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab
2. Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment
3. Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study
4. Diagnosis of a new primary malignancy since enrollment into the parent clinical study
Study of Decitabine Combined With HAAG Regimen in Newly Diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL With Myeloid or Stem Cell Markers Patients

The purpose of this study is to evaluate the efficacy and safety of decitabine combined with HAAG regimen in the treatment of newly diagnosed patients with ETP-ALL/LBL, T/M-MPAL and ALL/LBL with myeloid or stem cell markers.

This is a phase 3, open label, single arm, multi-center study in newly diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL patients who have myeloid or stem cell markers. The patients will receive decitabine combined with HAAG regimen in the induction treatment. The patients who respond to induction chemotherapy will undergo consolidation chemotherapy, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with decitabine according to patient's wishes.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed ETP-ALL/LBL, T/M-MPAL according to the 2016 revision to the WHO classification of myeloid neoplasms and acute leukemia, and T-ALL/LBL with one or more of the myeloid or stem cell markers (CD34, CD117, HLADR, CD13, CD33, CD11b or CD65) on at least 25% of lymphoblasts.
2. Age 15-60.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-2.
4. No history of previous chemotherapy or target therapy.
5. Provide informed consent.

Exclusion Criteria:

1. Patients with another malignant disease.
2. Patients has participated in or participating in other clinical trials.
3. Patients with uncontrolled active infection.
4. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
5. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
6. Patients with creatinine clearance rate \< 50ml/min.
7. Patients with active hepatitis B or hepatitis C infection.
8. Patients with HIV infection.
9. Patients with active tuberculosis infection.
10. Patients with uncontrolled active bleeding.
11. Patients with a history of allergy to experimental drugs.
12. Patients with other commodities that the investigators considered not suitable for the enrollment.
Efficacy of Local Anesthetic Through Continuous Infusion

Efficacy of using continuous infusion of local anesthetic for post operative pain control following laparotomy.

This study will evaluate the benefits of placing an analgesic pain pump in laparotomy incisions with the addition of intravenous/oral pain medications as needed versus using solely intravenous and oral pain medications as needed for post-operative pain management. The goal of this study will be to decrease the usage of narcotics in post-operative laparotomy patients by providing local incision pain relief. This will be a double blinded randomized control study with placebo with two groups of patients: One with a local anesthetic infusion pump filled with Bupivacaine, a local anesthetic, after laparotomy and the other group with an infusion pump filled with normal saline. The pain pumps will be placed in the OR. Post-operatively, all patients will have the standard pain regimen available to them during their stay. Surgeons will monitor the patient for 4 days post-operatively and the infusion pain pump will be removed on post-operative day 4. Investigator will then look back through each patient's records and gather the amount of pain medications that they requested during their stay. Both groups will then have their data collected in the same manner and placed for data analysis. - The standard pain regimen will include a morphine IV 4mg every 4 hours and Hydrocodone-acetominophen 5/325 Q6H PRN. If a patient controlled analgesia infusion pump is needed this will be considered a need for increase in pain management. Every patient will be started on this pain regimen post operatively. During their stay, If the patient requires an increase in their pain medication, the supervising attending will determine which drug will be added in improve their pain. At the end of the patients stay, the amount of narcotic usage will be compiled and turned into morphine equivalents in order to compare them with the control group.

Eligibility Criteria:
Inclusion Criteria:

- Patients scheduled for elective laparotomy

Exclusion Criteria:

* Emergency laparotomy
* Pregnancy
* Patients on chronic pain medication
Rivaroxaban ACS Specialist Cohort Event Monitoring Study

Rivaroxaban is a medicine which reduces the formation of blood clots. Acute coronary syndrome (ACS) comprises a range of disorders, including heart attack and unstable angina, caused by a sudden reduction in blood flow to part of the heart muscle. This study aims to collect information on the use of rivaroxaban and its safety when used by patients for the prevention of atherothrombotic (plaque rupture leading to a blood clot) events following ACS, during the first three months after starting. This study was requested by the European regulatory body (EMA) which is responsible for the use and safety of medicines. It will last for approximately 3 years and is a national study covering the whole of England and Wales. The study aims to recruit 1193 patients who have been prescribed rivaroxaban and antiplatelet therapy and 1193 patients who have been prescribed alternative dual antiplatelet therapy for the secondary prevention of atherothrombotic events following ACS. Each patient will only be monitored for the first 13 weeks after hospital admission for ACS. Patients who choose to take part will complete a consent form. The patient's care team will be asked to complete a baseline questionnaire about the patient at the time the medicine is given and a further questionnaire up to 16 weeks later, specifically asking about the patient's experiences whilst on the medication. If anything unusual is reported during the observation period, the care team may be asked to fill out a followup questionnaire. With the patient's consent, the study team will also inform the patient's General Practitioner (GP) of their participation in the study and will ask the GP to complete an abridged questionnaire from the patient's medical records. The study team will analyse and aggregate the data, carefully protecting patient confidentiality, to classify adverse events of interest, in particular bleeding events.


Eligibility Criteria:
Inclusion criteria:

* Age 18 years or above
* Patients newly prescribed rivaroxaban in any combination with standard oral antiplatelet therapy for the indication of secondary prevention in patients after ACS
* Patients prescribed dual antiplatelet therapy (contextual cohort) for the indication of secondary prevention after ACS
* Patients have provided signed, informed consent

Exclusion criteria:

* Patients prescribed with oral anticoagulants including rivaroxaban within 6 months prior to the index date for any indication
* Patients commenced rivaroxaban between date of market launch (28th October 2014) for the indication of secondary prevention after ACS and study start (18th September 2015)