cyrilzakka/clinical-trials huggingface dataset:
Compound Staphylococcal Lysostaphin Vs. Chlorhexidine Mouthrinse for Oral Mucositis in Patients Undergoing Allo-HSCT

Oral mucositis (OM) is a common complication in patients receiving myeloablative conditioning allogeneic hematopoietic stem cell transplantation (allo-HSCT). Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM, yet its use is hampered by issues like tooth discoloration, unpleasant taste, and pain on ulcerated surfaces, leading to reduced patient compliance. This study aims to demonstrate the non-inferior efficacy of a compound Staphylococcal lysostaphin mouthrinse to that of chlorhexidine mouthrinse in reducing OM occurrence in patients receiving myeloablative conditioning allo-HSCT.

This study aims to demonstrate the non-inferior efficacy of a compound Staphylococcal lysostaphin mouthrinse (Xinjingjie Mouthrinse®) to that of chlorhexidine mouthrinse in reducing OM occurrence in patients receiving myeloablative conditioning allo-HSCT. It also seeks to observe patient treatment adherence and pain, so as to provide evidence for the appropriate OM prevention and management measures in clinical practice. This randomized, controlled, non-inferiority clinical trial was conducted at the Bone Marrow Transplant Center, the First Affiliated Hospital of Medical College, Zhejiang University from January 2020 to December 2021.

Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant hematological diseases who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT) from fully matched sibling donors, unrelated donors, or haploidentical related donors.
* The conditioning regimen is myeloablative, specifically the BUCY regimen (comprising cytarabine, busulfan, and cyclophosphamide), with methotrexate used for graft-versus-host disease (GVHD) prophylaxis. The dosage of cytarabine is ≥4.0g/m²/day, busulfan is ≥3.2mg/m²/day, and cyclophosphamide is ≥1.8g/m²/day.
* There are no restrictions on age or gender.
* Patients voluntarily agree to participate in this trial.

Exclusion Criteria:

* Patients with an expected survival time of less than one month;
* Patients who have already developed oral mucositis (OM) prior to conditioning;
* Patients undergoing autologous stem cell transplantation;
* Patients receiving a non-myeloablative conditioning regimen.
Comparison of TrIfecta and Perimount Magna Ease

The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 75 years
* Elective aortic valve replacement in patients with predominant aortic stenosis

  * including concomitant CABG and/or atrial fibrillation ablation and/or supracoronary aortic replacement
* Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.
* Native German speakers (quality of life questionnaire in German language)

Exclusion Criteria:

* Isolated aortic regurgitation
* Concomitant aortic regurgitation \> 2°
* Endocarditis
* LVEF \<40%
* Concomitant other valve surgery
* s/p valve surgery
* Contraindication for stress echocardiography
Misopristol Versus Pitocin for Second Trimester Abortion

Second trimester abortion can be done surgically or medically. Medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. The investigators recent study proved the efficacy of pitocin after mifepristone in second trimester abortion with minimal side effects.

Working hypothesis and aims: To compare misopristol and pitocin after mifepristone preparation in second trimester in seccess rate, interval to abortion, side effects and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* midtrimester late abortion
* midtrimester induced abortion

Exclusion Criteria:

* placenta previa
* infected abortion
* rupture of membranes
* s/p cesarean section \*2 or more
A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer

This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed, histologically confirmed, locally advanced, stage III unresectable non small cell lung cancer (NSCLC).

   Staging will be confirmed at screening by positron emission tomography-computed tomography (PET/CT) and brain imaging by magnetic resonance imaging (MRI) or computed tomography (CT) with contrast.
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
3. Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) gene translocation status available prior to randomization.
4. Provision of fresh or archival tumor tissue or discussion with Sponsor.
5. Adequate hematologic and end-organ function.

Exclusion Criteria:

1. Prior therapies including those targeting PD-1 or PD-L1 or chemotherapy, radiation, targeted therapy, biologic therapy, immunotherapy or investigational agent used to control non-small cell lung cancer (NSCLC).
2. History of severe hypersensitivity reactions to other monoclonal antibodies or any contraindication to the planned chemotherapy regimen.
3. History of, or ongoing, interstitial lung disease; pneumonitis requiring steroids; or clinically significant pericardial effusion.
4. Any active malignancy less than or equal to 2 years before randomization, with the exception of non-small cell lung cancer (NSCLC) and any locally recurring cancer that has been treated curatively.
5. Severe chronic or active infections including those requiring systemic antibacterial, antifungal or antiviral therapy; known human immunodeficiency virus (HIV) infection; untreated chronic hepatitis B or chronic hepatitis B virus carries or active hepatitis C; or active autoimmune disease.
6. Prior allogeneic stem cell transplantation or organ transplantation.
7. Significant cardiovascular disease or other condition which places the patient at risk.
A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

This study will evaluate the potential drug-drug interaction of Dimebon with the FDA-recommended CYP2C9 substrate warfarin in healthy subjects. Conformance with the guidance includes general study design using a randomized, open label, single-dose warfarin, steady-state Dimebon, 2-sequence, 2-treatment, 2-period crossover design with a minimum 7-day washout period between treatments.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non-childbearing 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).
* Prothrombin time (PT)/INR, and partial thromboplastin time (PTT).
* Plasma Protein C and Protein S activity (functional) within the normal reference range.

Exclusion Criteria:

* A known sensitivity or previous intolerance to Dimebon or warfarin.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Subjects receiving warfarin for treatment of active thromboembolic events (ie, pulmonary embolism, deep vein thrombosis), as well as subjects anticoagulated with prosthetic heart valves.
Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients

This project aims to (1) define and characterize brain networks of cognitive flexibility amongst patients with frontal lesions; (2) quantify the effects of ecological cognitive trainings and brain stimulation on behavioral performance and brain networks; (3) identify predictive markers of effective rehabilitation (patients)

Decision making impairments and perseveration are frequently observed in patients with frontal lobe lesions, associated with overall chronic and serious deficits in executive functions. In order to improve mental flexibility, patients can benefit from reeducation based on regular training of executive functions along with a non-invasive brain stimulation. One of the key areas for such processing is the prefrontal cortex. Previous studies have shown however that maintaining a good level of mental flexibility in complex tasks involves a dynamic integration of several brain areas distributed in large networks. These areas in cooperation can be solicited by a multi-modal intervention such as motor-cognitive tasks associated with a transcranial stimulation. The goal of the present project is to develop a new rehabilitation program and to assess its impact in comparison with current programs. The investigators will also develop new methods to measure long term cerebral modifications induced by these programs. This goal will be reached by: 1) the identification of the brain networks of mental flexibility. 2) The assessment of multimodal task effects associated with or without a transcranial brain stimulation. Behavioral (performance in executive tasks) and functional (parameters of cerebral functional connectivity networks at rest) measures will be used. 3) The identification of mental flexibility predictors. The goal will be to find which initial individual's parameters of brain functional connectivity at rest could predict an optimal level of mental flexibility after training. This project aims at improving the quality of life in the brain-damaged population; impact that could eventually extend to the other parts of the population.

Eligibility Criteria:
Inclusion Criteria:

* Affiliated to social security
* Signed informed consent
* Mother tongue: French
* Right handed (Edimburg Scale)
* Frontal traumatic brain injury or stroke responsible for a dysexecutive syndrome assessed by the GREFEX battery.

Exclusion Criteria:

* Claustrophobia
* Addiction
* Major Hearing or Visual loss
* Hearing prosthesis
* Metal intraocular implant
* Cardiac prosthesis
* High Blood pressure
* Severe cardiac insufficiency
* Uncompensated thyroid disorders
* Major neuropsychological disorder
* Family or personal history of epilepsy
* Pregnancy
* Female subject of childbearing age not receiving effective contraception.
* Participation in another experimental protocol involving brain stimulation within the last 4 weeks
* Person under the protection of justice, tutorship or curatorship
* MRI contraindication
* Refusal to be informed of a new anomaly detected during the MRI examination
* Other traumatic brain injury or neuropsychological disorder
Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.

Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients transplanted for at least 3 months
* Stable renal graft function

Exclusion Criteria:

* No home internet access
* Major disability
Effectiveness of Character Strengths-based Intervention Among Breast Cancer Patients

The research design is a randomized control trial to evaluate the effectiveness of character strengths-based intervention in enhancing self-esteem, quality of life and alleviating depression in breast cancer patients. The type of intervention is psychological intervention. Participants in the intervention group will receive character strengths-based intervention. Participants in the control group will receive placebo control care.

The character strengths-based intervention may could enhance self-esteem, quality of life and alleviate depression, but the placebo control care did not do so.

Strengths use is indeed associated with elevated levels of life satisfaction and quality of life. It is positively related to self-esteem and leads to greater self-esteem over time. Moreover, strengths use could help decrease depression in the patients, and has beneficial effect on quality of life. There is a model that examined the mechanism of how strengths use related to enhanced self-esteem, happiness and life satisfaction. Individuals who use their strengths and experience greater levels of life satisfaction is mediated by self-esteem and depression.

Preliminary evidence suggested that character strengths-based intervention has positive impact on psychological well-being include improving self-esteem among women with breast cancer in Spain. However, there is a worldwide paucity of rigorous trials that have evaluated the effectiveness of character strengths-based interventions for breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* have a confirmed diagnosis of breast cancer;
* aged above 18 years old;
* native Chinese and proficient in oral mandarin communication;
* agree to participate in the study and offer a written informed consent regarding their voluntary;
* are able to comprehend and complete the questionnaires independently.

Exclusion Criteria:

* suffering from other or multiple life-threatening diseases;
* psychosis (for example, delusional disorder, schizophrenia);
* having participated in any type of group or individual psychological intervention in the past half year.
A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery

The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is:

- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics.

The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* outpatient surgery
* no age limit
* accepted post-operative monitoring by text messages (SMS)

Exclusion Criteria:

* refusal of post-operative follow-up by text messages (SMS)
Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation

The purpose of this study is to evaluate the efficacy of high-intensity non invasive mechanical ventilation (during one year to reduce the severity and frequency of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in patients with frequent AECOPD (frequent exacerbations defined more two or more AECOPD) and in GOLD IV stage (very severe COPD). The design is a randomised, double blind and controled with placebo (sham maneuver) clinical trial.

Background:

* There are many previous studies (no controlled trials or observational studies)that demonstrated minimal benefits (on gas exchange and marginal effect over exacerbations frequency) with the use of non invasive mechanical ventilation, in BiPAP modality with IPAP pressures \<18H2ocm (low intensity), in COPD patients.
* In subsequent years there were controled trials that concluded that there was no benefits with the use of non invasive mechanical ventilation on BiPAP mode in COPD patients ( It should be mentioned that in most trials were used low inspiratory pressure levels, that is called low-intensity non invasive mechanical ventilation).
* However, there are other recent studies that described some benefits of high intensity Bilevel modality of non invasive mechanical ventilation (inspiratory pressures \>18cmH2O) specially on gas exchange, quality of life and functional status.
* There are some issues that do not yet have a clear answer like the optimal inspiratory pressure (IPAP) or the ventilation modality (BIPAP or other) to obtain the maximal benefit on COPD patients. Additionally, is not clear also if the use of non invasive mechanical ventilation on COPD patients helps to reduce the frequency and severity of acute exacerbations of COPD (AECOPD).

This study have some characteristics that are different to the previous reports:

* The inclusion of patients with frequent exacerbations phenotype (and therefore worst prognosis patients)that there are no included in previous trials
* The intervention maneuver that is bilevel modality of non invasive mechanical ventilation at hig-intensity pressure (\>18H2Ocm and \<24H2Ocm)
* The use of placebo maneuver (CPAP "Sham")
* The home titration in three phases, over a week
* The long-term use of the intervention and sham maneuver

Eligibility Criteria:
Inclusion Criteria:

* Clinical and spirometric diagnosis for COPD (FEV1/FVC \<70%)
* Clinical phenotype of frequent exacerbations
* Must sign the informed consent
* Former smokers
* Stable COPD
* FEV1 \<35%
* Optimal medical treatment

Exclusion Criteria:

* OSAS diagnosis
* Other indications for non invasive mechanical ventilation
* Arterial pressure for dioxide carbon \>45mmHg
* Lung cancer
* Impossibility for doing spirometry or going to the medical visits
* Be included in another study
Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

Rehabilitation robotics has the potential to facilitate rehabilitation at home and empower people with spinal injuries to self-manage increasing their independence and improving their quality of life.

The objective of this study is to assess for the first time in the NHS the efficacy of a commercial robotic orthosis for upper limb rehabilitation in patients with spinal cord injury. The device is produced by Myomo (myomo.com) which is an American company. We will be assessing the wearable robotic orthosis also known as robotic exoskeleton in two different neuro-rehabilitation centres: National Spinal injuries Unit in Glasgow (Scotland) and The Robert Jones and Agnus Hunt Orthopaedic Hospital in Oswestry (England). The study will involve nine spinal cord injured tetraplegic inpatients in total.

Patients will follow a twelve-week rehabilitation programme with three to four sessions per week in addition to their usual care and rehabilitation. Each session lasts for approximately 45 minutes. Participants arm function, range of motion, spasticity level will be measured before, half-way and at the end of the programme to assess change in these and other parameters. Training will focus on the dominant arm of the patient and compared to the other arm at every assessment stage.

We shall evaluate therapists' and patients' satisfaction with the commercial device in addition to assessing various clinical measures to evaluate the efficacy of using the robotic orthosis in rehabilitation and recovery of arm function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years.
* The levels of C5 C6 Asia C/D would provide individuals with elbow and hand impairment and potentially functional shoulder movements. C7, C8 individuals could also benefit from the hand component of the device.
* Some gross shoulder movement at start of the trial to enable changes at the elbow/hand, to have the greatest potential for functional change.
* Preservation of hand sensation as base for motor restoration.
* Some sitting balance would give the best opportunity for the arm to be released for functional upper limb activity.
* EMG (muscle activity) evidence of active finger flexion, extension and elbow flexion extension Grade 1-2.
* Minimal or No community functional use of upper limb at start of trial.
* Spasticity MAS 1-3/5.
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, based on an assessment of medical history, physical examination and
* BMI between 21 and 30 kg/m2 (21 inclusive)

Exclusion Criteria:

* Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner
* Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological
* The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial