cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia

This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients \<18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.


Eligibility Criteria:
Inclusion Criteria:

* Mixed-lineage leukemia (MLL) gene rearranged Acute Lymphoblastic Leukemia (ALL), that does not respond to treatment or has relapsed from prior treatment; or FLT3 mutated Acute Myeloid Leukemia (AML) that does not respond to a second treatment or has relapsed from 2 prior treatments
* Normal organ function, and chest x-ray
* Expected survival greater than 8 weeks
* Can care for most of personal needs and perform at least minimum activity

Exclusion Criteria:

* Patients with symptomatic leukemic central nervous system involvement or isolated extramedullary leukemia
* Patients must not have received other treatments for leukemia within a predefined time period, 72 hours for medications, 2 months for transplants
* Patients with heart function that is not normal
* Patients with HIV or hepatitis
* Patients with another severe disease or medical condition besides leukemia Other protocol-defined inclusion/exclusion criteria may apply
Effect of Vitamin D on Periodontal Disease

Background. Vitamin D has both direct effects on bone metabolism and an antimicrobial effect on periodontopathogens. It also inhibits inflammatory mediators that contribute to periodontal destruction. The purpose of this study was to evaluate the association between serum 1.25-hydroxyvitamin D (1.25(OH)2D3) and 25(OH)D levels and periodontal inflammation.

Methods. This study included 28 subjects with chronic gingivitis, 29 subjects with chronic periodontitis and 25 periodontally healthy subjects. Blood samples were collected from the participants to determine serum levels of 25(OH)D, 1.25(OH)2D3, tumour necrosis factor α (TNF-α), C-reactive protein (CRP) and interleukin 6 (IL-6). Clinical parameters were recorded. Results were statistically analysed with a Shapiro-Wilk's test, Mann-Whitney U test, Kruskal-Wallis H test, Wilcoxon test and post-hoc multiple comparison test.

The subjects included in the study were selected from among patients who applied to our clinic, for routine periodontal examinations. Individuals who had been using immunosuppressive drugs and antibiotics for the past three months, smokers, individuals who had periodontal treatment within the past six months, and individuals with additional or supplementary vitamin D and systemic diseases were excluded from the study. In addition, since the region's level of sunlight exposure may have an effect on the level of vitamin D, participants were required to live in the region for the last five years.

A total of 82 subjects, including 25 as a periodontally healthy control group, 28 with chronic gingivitis and 29 with chronic periodontitis, were included in the study. Clinical criteria for chronic periodontitis are the formation of plaque and calculus and ≥ 5 milimeter (mm) pocket depth or attachment loss in more than 30% of the teeth. Diagnosis criteria for chronic gingivitis are the formation of plaque and/or calculus in the mouth, bleeding, and no loss of pocket or attachment. The diagnosis criteria for periodontally healthy individuals are having clinically healthy periodontal tissues or minimal periodontal inflammation, with no loss of pocket or attachment.

Eligibility Criteria:
Inclusion Criteria:

* live in the region for the last five years.

Exclusion Criteria:

* individuals who had been using immunosuppressive drugs and antibiotics for the past three months, smokers, individuals who had periodontal treatment within the past six months, and individuals with additional or supplementary vitamin D and systemic diseases.
Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.

The main hypothesis of the study is that Bezlotoxumab is well tolerated and effective in reducing the recurrence of ICD (Clostridium Difficile infection) in patients with a high risk of recurrence in the first episode of ICD.

As a consequence, the number of readmissions and hospital stays, will be reduced in patients treated with Bezlotoxumab.

This is a comparative study of patients with a high risk of recurrence of ICD in the first episode, treated with Bezlotoxumab (together with standard ICD therapy), with patients with first episode of ICD from a paired retrospective cohort (1: 2) using a propensity score.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have granted the IC and who are going to comply with the study visits and procedures according to their life expectations.
* Patient ≥ 18 years of age
* Having a first episode of DCI and presenting an estimated recurrence risk greater than 35%.

Exclusion Criteria:

* Patients \<18 years old
* Pregnant or lactating women
* Women of childbearing age who are not willing to use an appropriate contraceptive method (such as oral contraceptives, intrauterine device or contraceptive barrier method along with spermicide or surgical sterilization) during the study.
* Life expectancy less than 6 months
* Impossibility or serious difficulties of clinical follow-up
* Any digestive disease that, at the discretion of the researcher, makes it difficult to assess the response due to impaired bowel habits.
* Immunoglobulin treatment in the last 3 months
* Previous treatment with Bezlotoxumab
* Treatment with an experimental drug in the previous 30 days or participating or planning to participate in any other clinical trial with an experimental drug during the 12-week trial period.
* Anti- ICD treatment forecast for more than 14 days (eg vancomycin in descending pattern) for the current episode.
* Health center staff
* Direct family members of the research team
The Effects of Simulated Competition on Repeated-sprint Cycling Performance

Sprint cycling performance has been found to be reduced when two sprints were undertaken 12 minutes apart. In a follow-up study, the investigators found evidence to suggest that some of the loss in performance that was experienced in the second sprint was due to a psychological, rather than a physiological, limitation. It is conceivable that this loss in performance would not exist during a competition. The aim of this study is, therefore, to investigate the influence that a competitive environment has on repeated-sprint performance.


Eligibility Criteria:
Inclusion Criteria:

* regular strength/sprint training (at least 2 sessions per week)

Exclusion Criteria:

* Injured or a contraindicative medical condition
Optimal Timing of Coronary Artery Bypass Grafting in Hemodynamically Stable Patient After Myocardial Infarction and Definition of Poor Prognostic Factors. Pilot Study

Acute coronary syndromes (ACS) represent the leading cause of death in France. Their incidence is increasing due to population aging and to the persistence of cardiovascular risk factors. Currently, revascularization surgery remains outside the emergency treatment, because early performed, it tends to lead to extension and hemorrhage of the infarcted area, because of the CPB, aortic clamping, cardioplegia, and other heart manipulation.

However, CABG are indicated as an emergency in some situations of STEMI: Threat of infarction of an extended territory without favorable anatomy to angioplasty, anatomy not favorable to angioplasty associated with cardiogenic shock or persistent ischemia, acute complications of myocardial infarction (massive mitral insufficiency, interventricular communication, parietal rupture) requiring surgery under CPB with concomitant bypass surgery or failure of angioplasty (proximal coronary dissection).

Operative mortality is high; 15 to 20% for patients operated 12 to 48 hours after AMI and 4-5% for those operated after 48 hours.

Nevertheless, it seems legitimate to study if there would be a place for primary surgical revascularization in case of patient with hemodynamically stable ACS, in order to limit myocardial ischemia, spread of necrosis, to limit the risk of recurrence, and the consequences of low cardiac output. Performing a complete early surgical revascularization could limit the ischemia-reperfusion syndrome and anticipate the occurrence of cardiogenic shock.

Trial on medical records only

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting acute myocardial infarction with hemodynamic stability at the diagnosis
* Patients undergoing coronary artery bypass in Dijon University hospital

Exclusion Criteria:

* Patients with Acute pulmonary oedema
* Patients with cardiorespiratory arrest before coronary angiography
* hemodynamically unstable patient at diagnosis
* patients requiring combined surgery
* patients with unstable angina
Clinical Study on the Safety and Effectiveness of Vagus Nerve Stimulation in the Treatment of Refractory Depression

Based on the mechanism hypothesis and clinical efficacy of VNS in treating refractory depression, this study will evaluate the safety and efficacy of VNS in treating refractory depression through a small sample of clinical trials

This clinical trial is a prospective, self - controlled clinical validation study. Subjects who met the inclusion criteria and did not meet the exclusion criteria were screened to enter the test. After admission, subjects received vagus nerve stimulation and conventional treatment. Enrolled 10 subjects. Parameter setting and observation were performed 2 weeks after implantation of the vagus nerve stimulation lead and pulse generator, and follow-up evaluation was performed at 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. patients with treatment-resistant depression (patients with Hamilton depression scale (HAMD) score reduction rate still less than 50% after adequate treatment with two or more antidepressants)
2. age 18-65; Male or female
3. the patient has a depressive course of 2 years or more or has 2 or more major depressive episodes
4. HAMD-17 score\> 17 was at baseline

Exclusion Criteria:

1. pregnant or lactating women, women of childbearing age who plan or have no safe contraceptive measures
2. a patient who is or has been diagnosed with a mental disorder other than depression; Depressive episode with psychotic symptoms
3. patients currently at serious risk of suicide
4. prior 12 months of alcohol or substance dependence, or prior 6 months of substance abuse other than nicotine
5. patients with cardiovascular diseases (myocardial infarction or cardiac arrest) and organic brain diseases (such as cerebral hemorrhage, massive cerebral infarction, encephalitis and epilepsy)
6. accept other clinical trials
7. patients requiring systemic mri after implantation
Kirschner Wire and Pull-out Wire Fixation for the Treatment of Bony Mallet Finger

The objective of this report is to describe a new surgical technique for the treatment of bony mallet finger which involves the application of both Kirschner wire and pull-out wire fixation. It is believed to decrease the risk of the complications.

From May 2003 to December 2008, we used Kirschner wire and pull-out wire fixation to carry out 54 closed bony mallet finger in 54 patients. The bony mallet finger was applicated both Kirschner wire and pull-out wire fixation.

Eligibility Criteria:
Inclusion Criteria:

1. bony mallet finger;
2. patient had failed trials of nonsurgical treatment;
3. fracture involving more than 1/3 of the joint surface;
4. fragment displacement or subluxation of the DIP joint.

Exclusion Criteria:

1. tendinous mallet finger;
2. success of nonsurgical treatment;
3. comminuted fracture;
4. fracture involving at or less than 1/3 of the joint surface which could be successfully replaced with nonsurgical treatment.
A Single Dose Study Of PF-05161704 In Healthy Volunteers

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening or positive cotinine test at screening or Day 0 of period one
Prevention of Acute Cholecystitis With ETGBD

The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.

In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.


Eligibility Criteria:
Inclusion Criteria:

1. Adults 19 years of age or older
2. Patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes.
3. Patients with imaging (CT, Cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct.
4. Patients who have voluntary informed consent to participate in the study.

Exclusion Criteria:

* Patients who have undergone percutaneous/surgical bile duct or gallbladder drainage prior to study enrollment.
* Patients with anatomic deformity of the upper gastrointestinal tract after gastric or hepatobiliary surgery
* Patients with concomitant gastric/duodenal obstruction
* Patients with confirmed or suspected cystic duct obstruction on imaging studies
* Patients with acute cholecystitis, acute pancreatitis
* Patients who underwent cholecystectomy
* Patients with a life expectancy of less than 3 months
* Patients who are otherwise unable to undergo endoscopic retrograde cholangiopancreatography
The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.


Eligibility Criteria:
Inclusion Criteria:

* premature newborns (\<32 weeks gestation, stratified \<28 weeks versus \>28 weeks) \<8 days of age
* receiving lipid infusions \<1 g/kg/day at enrollment
* anticipated to be treated with 3 g/kg/day for a minimum of 48 hours.

Exclusion Criteria:

* patients with direct hyperbilirubinemia \>1.5 mg/dl
* with suspected sepsis meeting Systemic inflammatory response syndrome (SIRS) criteria
* undergoing treatment with a continuous infusion of morphine
* with a continuous infusion of pressors (dopamine, dobutamine, epinephrine, etc.)
* positive blood cultures
A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers

This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention \[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\] compared to an attention control.

This is a multicenter randomized controlled trial with four sites that assesses the efficacy of a decisional intervention \[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\] compared to an attention control. Subjects will be randomized 1:1 to either the intervention arm or the attention control arm. Compared to an attention control, UR-GOAL will improve patient distress, observed and patient-perceived shared decision making (SDM), and patient decisional conflict.

Eligibility Criteria:
Patients

Inclusion criteria:

* Age ≥60 years (from date of consent, confirmed on electronic medical records)
* A diagnosis of AML

  * Diagnosis can be based on the International Consensus Classification or World Health Organization
  * Myeloid sarcoma is allowed
* Cancer-directed treatment has not started (e.g., hydroxyurea, leukopheresis, or treatment to temporarily decrease white blood cells is acceptable)
* The patient's oncologist has been or will be enrolled on the study
* English or Spanish-speaking
* Patients without a caregiver will still be eligible to participate in the study

Exclusion criteria

* A diagnosis of acute promyelocytic leukemia
* Patients with psychiatric or cognitive conditions which the treating oncologist believes prohibits informed consent or compliance with study procedures
* Prior cancer-directed treatment for AML (hydroxyurea is acceptable)

Caregivers

Inclusion criteria:

* Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 18 or older\] with whom you discuss or who can be helpful in health-related matters."
* Caregiver may be paid/professional or informal caregiver
* Able to provide informed consent
* English or Spanish-speaking
* Caregiver may enroll any time before the patient's next clinical visit with the oncologist, following the completion of procedures in either the UR-GOAL intervention or attention control arms

Oncologists

Inclusion criteria:

* Oncologists caring for patients with AML Exclusion criteria
* None
Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep

The aim of this study was to evaluate the dynamic changes of the tongue in patients with obstructive sleep apnoea hypopnea syndrome (OSAHS) during sleep and while awake by using Ultrafast Magnetic Resonance Imaging (UMRI)

UMRI was undertaken on the upper airway in 21 OSAHS patients and 20 normal people after being deprived of sleep for one night. A series of midline sagittal images of the upper airway were obtained. The dynamic alterations of the tongue size and the distance from the tongue to X axis (an extended line from the anterior nasal spine to posterior nasal spine) and Y axis (a perpendicular line from the center of the pituitary to the X axis) were measured.Statistical comparisons between pairs of means were performed via t-tests using Spss10 software. A probability level of p\<0.05 was considered to be statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. patients who are male
2. patients were diagnosed as OSAHS
3. patients underwent a thorough history (including the Epworth somnolence questionnaire) and physical examination
4. patients did not undergo any treatment
5. each subject gave written informed consent before entering the study.

Exclusion Criteria:

1. patients didn't sign written informed consent
2. Any situation or condition that will interfere with adherence to study activities
Efficacy of Training Programme to Reduce Stress

This study aims to reduce stress in mothers of children with autism in Saudi Arabia. The researcher has designed a training programme for mothers whose children are young and just in their early stage at the autism organisations they are attending. The programme will include stress reduction tips, behavioural modification strategies for children with autism, and financial resources available to parents (how they can access government funding). The study will have two parts. Part one involves conducting an experiment by dividing the participants into two groups, one group will receive the training and the other group will wait until the end of the study then they will also receive the same training. Both groups will fill questionnaire at the beginning of the study, then after the first group finishes training, and then again 6 weeks later. Part two of the study will involve interviewing mothers of the first group who attended the training session. They will be interviewed by the researcher asking them about their experience with the training programme and their suggestions for future improvements. Mothers will be given a training manual at the beginning of the training. Training involves attending five sessions, one of which is a face to face session at the autism organisation their children are attending and the other four sessions will be through a Smartphone application called whatsapp which is widely used in Saudi Arabia.


Eligibility Criteria:
Inclusion Criteria:

* Mothers aged 18 years or over
* mothers of ASD children who are in the early intervention stage (first year in the programme) at autism organizations in Saudi Arabia

Exclusion Criteria:

* Mothers whose children with ASD are not in the early intervention stage or did not joint autism organization

  * Mothers who will not be willing to commence to the full duration of the trial
  * Mothers who will not be able to use whatsapp in their smart phones
The Registration on the Use of Feilike Heji in Minors

Feilike HeJi is produced by Guizhou Jianxing Pharmaceutical Co. LTD. For the treatment of phlegm heat caused by lung cough phlegm yellow, bronchial asthma, bronchitis, see the syndrome of proprietary Chinese medicine (approval number: Z20025136) approved by the state and the drug from radix scutellariae, radix peucedani, radix stemonae, red gentian root of deal, phoenix tree, spreading hedyotis herb, red tube 7 flavour, with qingrejiedu, antitussive expectorant effect. In order to fully understand the safety of Feilike HeJi in clinical practice and fulfill the responsibility of production enterprises for patients, the production enterprises initiated this study to further evaluate the safety and understanding of the function characteristics of Feilike HeJi in a wide range of people, so as to guide the clinical rational drug use.


Eligibility Criteria:
Inclusion Criteria:

* All minor patients (age \<18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) .
* Voluntarily participate in this study and meet ethical requirements.

Exclusion Criteria:

* Not Applicable.