cyrilzakka/clinical-trials huggingface dataset:
Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients

to observe the dose-limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride injection combined with cytarabine and decitabine in the initial treatment of acute myeloid leukemia (AML), to explore the maximum tolerated dose (MTD) of the combined D-CMG regimen, and to evaluate its safety and efficacy


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed acute myeloid leukemia (non-M3) that has not been previously treated and cannot receive standard cytarabine and anthracycline induction therapy due to age, comorbidities, or patient preference.
2. Aged 60-75 years, both male and female, with an expected survival time of more than 3 months.
3. Estimated creatinine clearance rate ≥ 30 mL/min.
4. AST and ALT ≤ 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement).
5. ECOG Performance Status ≤ 2.
6. Able to understand and voluntarily provide informed consent.

Exclusion Criteria:

1. Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16).
2. Active central nervous system leukemia.
3. History of myeloproliferative neoplasms (MPN), including myelofibrosis, primary thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and AML with BCR-ABL1 translocation.
4. HIV-positive patients and/or active HBV or HCV infection (as documented by positive HBV-DNA and HCV-RNA tests).
5. Clinically significant QTc prolongation (men \> 450 ms; women \> 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block, history of myocardial infarction within the past year, congestive heart failure, and coronary artery disease requiring medication.
6. Active, uncontrolled severe infection.
7. History of other malignancies within the past 2 years, except for adequately treated in situ carcinoma of the cervix or breast; skin basal cell carcinoma or localized squamous cell carcinoma of the skin.
8. White blood cell count \> 25 x 10\^9/L. (This criterion can be met with hydroxyurea or leukapheresis.)
9. Mental impairment that would compromise the ability to participate in the study.
10. Any other situation in which the investigator believes that it would not be in the best interest of the patient to participate in the trial.
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI

Tigecycline's activity against resistant organisms, as well as significant coverage of both gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in treating patients with complicated skin and/or skin structure infections.

To evaluate the safety and the efficacy of tigecycline in treating hospitalized patients with complicated skin and/or skin structure infections.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male and female patients, 18 years of age or older.
* Anticipated need for intravenous antibiotic therapy of 5 days or longer.
* Patients known or suspected to have a complicated skin and skin structure infection.

Exclusion Criteria:

* Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
* Patients with severely impaired arterial blood supply and insufficiency such that the likelihood of amputation of the infected anatomical site within one month is likely.
* Infected diabetic foot ulcers or decubitus ulcers where the infection is present for greater than one week's duration or chronically infected decubitus ulcers in patients who can not be compliant with measures necessary for chronic wound healing.
Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

OMS103HP is being developed for improvement in knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee motion and earlier return to work.

The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. Because of the dynamic nature, complexity and redundancy of the chemical mediators of inflammation and pain and their pathways, no currently available single drug has sufficiently broad spectrum of activity to effectively inhibit the inflammatory process. OMS103 provides a multicomponent approach to controlling the inflammation induced by arthroscopic surgery. It delivers three active ingredients, each with distinct pharmacological activities, directly to the site of surgical procedures to preemptively block the inflammatory cascade induced by surgical trauma.

Eligibility Criteria:
Inclusion Criteria:

* 17 - 65 years of age
* In good general health
* Undergoing arthroscopic ACL reconstruction for an ACL tear

Exclusion Criteria:

* Allergies to any of the individual ingredients in OMS103HP
* Has open physes in the distal femur or proximal tibia
* Undergoing bilateral knee surgery
* Subject who is considered by Investigator to be an unsuitable candidate
Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters

This study assesses the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.

Objective: To assess the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.

Design: Using a cluster-randomized study design with waiting-list controls, we test a six-month intervention administered once weekly by a nutritional expert consisting of joint meal preparation and activities for children and parents like tasting and preparing nutritious, fresh foods. At baseline, six and twelve months, a parent-completed questionnaire assesses fruit and vegetable intake (primary outcomes) and water and sugared drink consumption (other outcomes). Direct measurement assessed BMI, percentage body fat (skin fold thicknesses) and waist-to-height-ratio. An intention-to-treat analysis used random effects panel regression models to assess the intervention effect, adjusted for each child's age, gender, immigrant background and maternal education.

Setting: 18 Preschools from three south German regions. Subjects: Healthy children from three to seven years of age.

Eligibility Criteria:
Inclusion Criteria:

* Pre-schools were eligible to participate in the study if they were located in one of three predefined regions and had applied to participate in the nutritional intervention module of a state-sponsored health promotion programme 'Komm mit in das gesunde Boot' ('Come aboard the health boat'), with at least fifteen children participating.
* Healthy children in eligible preschools

Exclusion Criteria:

* Age under 3 years or above 7 years
* Serious health problems
* Genetic conditions
* Metabolic diseases
* Acute infectious diseases
Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

* Intervention Model:

  * Parallel: for all patients entering the trial
  * Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study
* Peginterferon alfa-2a
* Ribavirin
* Daclatasvir
* Asunaprevir

Eligibility Criteria:
Key Inclusion Criteria:

* Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
* Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
* HCV RNA viral load detectable

Key Exclusion Criteria:

* Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
* Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
* Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
* Evidence of medical condition associated with chronic liver disease other than HCV infection
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
C-BRACE Versus SCO in Community Ambulators

The purpose of this multicentric study is to assess the impact of C-BRACE on mobility, endurance, confidence, participation, satisfaction, psychosocial adjustment and quality of life in community ambulators using a Stance Control Orthosis.

During two months of inclusion period, the investigators invite all patients matching with inclusion criteria for an enrolment visit, collect written consent and record general patient information. The eCRF (electronic Case Report Form) assigns the enrolled patient into one group for the trial (C-BRACE/SCO or SCO/C-BRACE), in a randomized order. The assessments are performed after 2 month follow-up period with each orthosis with a minimal wash-out period of 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* person with knee locking deficiency
* person using a SCO (Stance Control Orthosis) for at least three months, walking with a swing phase on a flat ground, without walking aid or with one cane or one crutch.
* person having the ability to walk at 3km/h (measured with 10 meters walk test) with the SCO in unlocked mode.
* person with a stable stance phase on the contralateral side

Exclusion Criteria:

* person with deficient or unstable contralateral knee, including person using a Knee-Ankle Foot Orthosis on the contralateral limb
* person walking using two canes, two crutches, one or two underarm crutches or a walker
* person with health condition not compatible with the study protocol
* person under 18 years old
* person unwilling / unable to follow the entire study protocol / instructions
* person who did not give her written consent to participate to the study or unable to personally give her consent
* person with knee and/or hip flexion contracture \>10°
* person with genu varum / valgum \> 10° (not reducible)
* person with moderate to severe spasticity
* person with leg length discrepancy \> 15cm
* person who necessitate the use of an orthoprosthesis
* person with body weight \> 125kg
* person with unstable trunk in standing position
* person with cognitive impairments
Confocal Laser Endomicroscopy As an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.


Eligibility Criteria:
Inclusion Criteria:

* Patient age 18 years or older
* All patients referred for EUS-FNA of accessible PCL where surgery is contemplated
* Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies

Exclusion Criteria:

* Unable to obtain informed consent
* Unable to tolerate the procedure
* Women with known pregnancy at time of procedure
* Patient age less than 18 years
* Bleeding diathesis
* Known allergy to fluorescein
* Prior pancreatic cancer
* Prior pancreatic surgery
Perioperative Blood Pressure and In-hospital Morbidity After Coronary Artery Bypass Surgery

The prevalence of hypertension is high, estimated at 80% in patients with cardiovascular (CV) disease. The optimal blood pressure (BP) level for CV prevention remains controversial. Data from the literature highlight that the relationship between BP level and mortality is not linear, but rather J-shaped. In particular, in treated hypertensive patients with stable coronary artery disease, a systolic BP below 120 mm Hg is associated with the risk of recurrent coronary events and CV mortality.

An inverse relationship was recently demonstrated between BP level before revascularization procedure and mortality at 3 months and 1 year after the procedure in patients managed for critical ischemia. These data underline the need for a personalized approach to the management of hypertension, especially in elderly hypertensive patients with comorbidities.

The question of the optimal mean BP value also arises in cardiac surgery, especially during extracorporeal circulation in patients undergoing coronary artery bypass grafting. Hypotension during cardiac surgery appears to be associated with renal failure and perioperative mortality in some patients. Conversely, high blood pressure levels (above the cerebral autoregulatory threshold) may be associated with postoperative cognitive impairment and bleeding risk. In hypertensive patients, the autoregulatory capacity of cerebral and renal perfusion is partly impaired, with a greater susceptibility to ischemia in case of hypotension. Personalized blood pressure targets could be beneficial perioperatively with a lower risk of postoperative complications.

The objective of this protocol is to determine a correlation between perioperative mean arterial pressure level and in-hospital morbidity in a population of patients with ischemic heart disease managed for coronary artery bypass grafting (CABG). The results of this descriptive work would make it possible to introduce the problem of the optimal blood pressure target during extracorporeal circulation according to the existence of peripheral arterial damage and preoperative blood pressure values.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patient with ischemic heart disease managed for coronary artery bypass grafting (CABG) between 01/01/2016 and 12/31/2020
* French-speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his data for this research
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation.

Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injection. Three groups will be evaluated: group 1 will have the manipulation procedure on the day following collagenase injection, group 2 will have the manipulation procedure on the second day following collagenase injection,and group 3 will have the manipulation procedure on the fourth day following collagenase injection,

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (\> 18 years) of either gender with an metacarpophalangeal joint contracture and a palpable cord of \> 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture

Exclusion Criteria:

* Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture.
* Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
* Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
* Any subject with known allergy to Xiaflex (Clostridial collagenase).
* Any subject who cannot conform to the study visit schedule
A Study to Investigate the Safety and Clinical Effect of Nexagon® to Treat Persistent Epithelial Defects

The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with Persistent Epithelial Defects (PED) originally caused by chemical burns.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged 18 years and over.
2. Subjects who are able to attend all follow-up visits and who are able to comply with all study procedures.
3. Subjects who are willing and able to give written informed consent to take part in the study.
4. At the Day -7 visit subjects must have a corneal epithelial defect that has persisted for between 7 days and 14 days, which has a minimum diameter of 2 mm along the greatest axis, and which has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
5. The original defect to the cornea must have been caused by either alkaline or acidic agents.

Exclusion Criteria:

1. Use of concomitant ocular medications in the screening period that are not specified in standardized PED treatment regime
2. Likely to require the use of concomitant ocular medications that are not specified in the standardized PED treatment regime during the study follow-up period
3. Decrease or increase in the PED by more than 30% during the screening period.
4. Have an active lid or ocular infectious process of any sort
5. Subjects with corneal perforation or impending corneal perforation
6. The circumference affected by limbal blood vessel ischemia is greater than 75% of the circumference
7. Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
8. Subjects with bilateral PED, if the smaller PED has a longest diameter of \> 2 mm.
9. Female subjects who are pregnant or breastfeeding. F
10. Subjects who have a history of AIDS or HIV.
11. Subjects with any other condition which, in the Investigator's opinion, would exclude the subject from participating.
12. Treatment with systemic corticosteroids (equivalent to \> 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents within 7 days prior to Day 0, or likely to receive one of these therapies during study participation
13. Subjects who have participated in a clinical trial within 30 days prior to Day 0.
14. Diabetics with an HbA1c greater than 6.5%.
15. Diabetics who are currently prescribed more than one oral medication for their diabetes.
16. Subjects who have more than one distinct PED in the study eye.
Accuracy of Digital Implant Impression

This study aims to investigate the accuracy of complete-arch digital implant impression using newly designed scan bodies with extensional structure.

Fully edentulous patients with 2-6 dental implants are included in this study. For each patient, the follow three impressions are made: conventional splinted open-tray impression, digital impression using scan bodies without extensional structure, and digital impression using scan bodies with extensional structure. The accuracy of the three impressions is compared in an inspection software.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and able to understand an informed consent
* Fully edentulous jaw
* 2-6 dental implants have been placed in the edentulous jaw
* The implants have been osseointegrated
* Mouth opening larger than 4.5 cm

Exclusion Criteria:

* Poor oral hygiene
* Presence of peri-implantitis or peri-implant mucositis
* Presence of temporamandibular joint disease
* Unwilling to paticipate in the research
Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder

This preliminary study is designed to evaluate mechanisms by which excitatory dorsolateral prefrontal cortex (dlPFC) repetitive transcranial magnetic stimulation (rTMS) (vs. sham) and pharmacological stress (vs. placebo) alter behavior in non-treatment seeking individuals with opioid use disorder (OUD). Specific Aims are to (1) Evaluate how stress impacts domains of behavior including (1a) executive function and (1b) opioid-seeking behavior; and (2) Determine whether rTMS stimulation attenuates (2a) executive dysfunction, (2b) stress-reactivity, and (2c) opioid-seeking in individuals with OUD not receiving treatment.

This study will use a double-blind, 10Hz left dlPFC rTMS (vs. sham) and pharmacological stressor (\[yohimbine + hydrocortisone\] vs. placebo) within-subject, randomized crossover design. Each participant will complete 4 sessions (stressor vs. placebo, crossed with rTMS vs. sham), each separated by at least 1 week. Participants will complete these 4 (2x2 within subject) test conditions in randomized order: sham rTMS/placebo stress, sham rTMS/active stress, active rTMS/ placebo stress, and active rTMS/active stress.

The PI will perform randomization using a Latin Square and will assign participants to conditions and prepare medication (stressor or placebo) for each participant's sessions. The PI will keep others blinded and will not be involved in study assessments.

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-5 criteria for OUD;
* Age 21-60 yr;
* Right handed;
* Males and non-pregnant/non-lactating females;
* cognitively intact (total IQ score \>80 on Shipley Institute of Living Scale);
* Screening cardiovascular indices within ranges for safe use of the pharmacological stressor: resting HR 50-90 bpm, systolic BP 90-140 mmHg, and diastolic BP 50-90 mmHg;
* Use alcohol and/or marijuana \<3 times/week; each "time" should consist of \<1 marijuana "joint" equivalent and \<3 alcoholic drinks.

Exclusion Criteria:

* Under influence of any substance during session;
* Past 7-day use of illicit drugs other than opioids (except marijuana, which is legal in Michigan);
* Urinalysis positive for cocaine metabolites, benzodiazepines, barbiturates, amphetamines or pregnancy;
* Medical conditions prohibiting use of rTMS (e.g. seizure history; based on rTMS screening questionnaire);
* Lifetime diagnosis of: psychotic disorder, bipolar disorder, generalized anxiety disorder, or obsessive compulsive disorder; major depression in the past 5 years; or potentially antisocial personality disorder (if the clinical psychologist judges such behaviors to be potentially disruptive or unsafe in our lab);
* Past-year SUD other than OUD;
* Acute/unstable illness: conditions making it unsafe for participation (e.g. neurological, cardiovascular, pulmonary, or systemic diseases);
* Lactose intolerance (placebo dose);
* Any prohibited medications: medications that lower seizure threshold, psychiatric medications, prescription pain medications, or blood pressure medications;
* Chronic head or neck pain; and
* Past-month participation in a research study.