cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Oral Care Programme for Head and Neck Cancer Patients

This study will evaluate the effect of an intensified oral care programme on prevalence, severity and duration of mucositis in patients undergoing treatment for cancer in the head and neck region.

Patients in the control group get professional oral care once a week.

This study will evaluate the effect of an oral care programme on prevalence, severity and duration of mucositis in patients undergoing treatment for cancer in the head and neck region. The oral care programme consists of professional oral care and swabbing of the mucosal membranes with a saline/bicarbonate solution once a week. The patients are instructed to rinse with a saline/bicarbonate solution 5 times per day. They are given an oral care diary to help them keep track of their daily oral hygiene measures and rinses. Repeated oral hygiene instructions are given if needed.

Patients in the control group get professional oral care once a week.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to receive full dose of curative RT including major salivary glands in the radiation field

Exclusion Criteria:

* Patients with recurrent cancer
* Patients with severe cognitive impairment.
Customized Masks in Non-Invasive Mechanical Ventilation

In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and quality of therapy mainly depend on it. The aim of this study is to investigate the usefulness of a customised mask approach to minimise leakage and upper airway obstruction. It will focus on ventilator registries and changes in the way they can be corrected with these customised masks.

The process involves 3D face scanning and dedicated computer-aided design. The processing and manufacturing of the masks is based on additive manufacturing through 3D printing.

In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and the quality of therapy depend mainly on it. A deteriorated or inadequate mask can lead to unintentional leaks or jaw and tongue displacements, thereby increasing obstructive events in the upper airway. There is a growing interest in the use of personalized masks designed using facial scanning and 3D printing technology. Previous studies have demonstrated their effectiveness in complex patients, such as premature neonates, and healthy individuals, successfully reducing leaks and skin sores.

The aim of the project is to demonstrate the utility of a 3D-printed, customised mask to improve the quality of ventilation, primarily by reducing leaks and mask-related obstructions in adult patients receiving home NIMV. Two usage periods of NIMV will be studied, one month with a personalized mask created through 3D printing (M3D) and another month with a commercial mask (MC). The primary variable under study will be the difference in leak levels between M3D and MC throughout the study month with each of them. Variables derived from respiratory polygraphy, performed with each mask, will also be included, in addition to the patient's experience.

Eligibility Criteria:
Inclusion Criteria:

* Patient enrolled in the Home Mechanical Ventilation (HMV) program.
* Adherence of \>4 hours per day.
* In the case of COPD, inspiratory pressures \>18 cmH2O.
* Users of a Resmed HMV device to standardize and facilitate the analysis of the respirator log.
* Commercial masks (MC) in optimal condition, as assessed by the mechanical ventilation unit responsible during outpatient ventilation consultations.
* Presence of residual leaks (\>5 LPM on average according to the respirator log - ResScan, unintentional leaks, with intentional leaks excluded by software).

Exclusion Criteria:

* Patients with tracheostomy or scheduled for tracheostomy.
* Patients on a waiting list for lung transplantation.
* Patients using HMV devices from manufacturers other than ResMed.
* Users who alternate between various MC models, where homogeneity in interface use cannot be assured.
* Refusal to provide consent.
* Patients with documented allergies to components of medical-grade silicone used in the production of M3D.
* Exacerbations requiring hospitalization or changes in medication or the respirator in the last 3 months.
Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial

The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells therapy in patients with anaerobic (hypoxic) brain injury. Stem cell therapy is an emerging alternative treatment modality in incurable and intractable neurological disorders. This pilot study aims to evaluate the feasibility and safety of stem cells in anaerobic brain injury.

Various treatment modalities to minimize the neurological deficits of anoxic brain injury, including lower consciousness, abnormal movement disorders, and abnormal behavior, have been tried, but so far there have been no effective proven method for chronic patients.

This study is the investigator initiated trial to verify the safety and feasibility of stem cells therapy in patients with anoxic brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 14 days after the index event occurs in an oxygen-free brain injury patients
* Severe disability or moderate due to anoxic brain injury
* 18 years to 75 years
* Patients was 7 points less than Glasgow coma scale (GCS) After the resumption of blood flow circulation.
* anaerobic unexpected (hypoxic) cerebral ischemia Encephalopathy (It should not be a hypoxic brain ischemia was induced due to heart surgery, which is scheduled)
* Subjects agreed in writing that it will be participating in clinical research, as viewed from the legal representative (patient)

Exclusion Criteria:

* Patients who require ventilator continued
* Patients who had extracorporeal membrane oxygenation(ECMO) index event occurs at the time
* Patients who had a history of cardiac arrest prior to the occurrence of Index event
* End-stage people of less than 12 months is expected (incurable) disease patients
* Patients with cardiac arrest occurred due to brain trauma severe
* Patients with damage to other organs of severe
* Patients with bleeding or malignant current
* Pregnant patient
* Patients with central nervous system tumors undergoing radiation therapy or chemotherapy
* If the patient or are participating in other clinical trials, you are planning to participate, or patients three months after the end is not passed to participate in other clinical trials
Validation of the Neuropsychiatric Fluctuations Scale (EFN-VALID))

Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. The main goal of this project is to validate the NF-scale in french language in a multicenter approach.

Anxiety, sadness, lack of energy and motivation, fatigue and pain are common during the off-medication condition, whereas euphoria, well-being, impulse control disorders, behavioral addictions, mania, and psychosis might occur during the on-medication condition. Early diagnosis of NpsyF is crucial for their holistic management. Unfortunately, NpsyF are often under-recognized by patients or misdiagnosed by physicians due to the lack of specific assessment tools. The NFS is composed of 20 items among which ten measure the "ON neuropsychological state" and ten, the "OFF neuropsychological state". It provides two sub-scores (one ON and one OFF) with a maximal total score of 30.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* presence of motor fluctuations, requiring a levodopa test
* french native speaker

Exclusion Criteria:

* Dementia (MoCa \< 24)
* Parkinson syndrome other than idiopathic PD
* people excluded according to french law (including pregnant women or nursing mothers, ...)
A Basket Trial of Vunakizumab in Inflammatory Skin Diseases

This is a national multi-center, large sample size case registration clinical study. The registry population was patients with inflammatory skin diseases who were receiving treatment with vunakizumab. All outpatient and inpatient patients with inflammatory skin diseases who were receiving vunakizumab were eligible for enrollment. Patients' usual care was not affected by participation in the study. We only collected data in routine clinical practice.

The study had an enrollment period of 5 years or 10,000 patients were recruited early, whichever occurred first. All patients must provide written informed consent form before data collection, and each patient will be followed for 1 year to observe clinical progression.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ years；
* had adiagnosis of inflammatory skin disease；
* Is receiving or plans to receive vunakizumab for treatment;
* Patients provided written informed consent form.

Exclusion Criteria:

* no.
Effects of Epalrestat on Peripheral Neuropathy and Central Nervous System in Diabetic Patients

This study evaluated the efficacy of epalrestat in diabetic peripheral neuropathy and its effects on the central nervous system in diabetic peripheral neuropathy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 65 years (to the date of screening)；
2. A clear history of type 2 diabetes (using the 1999 WHO diabetes diagnostic criteria) with a course of disease \> 6 months;
3. HbA1c \< 7%;
4. Two or more of the following five tests are abnormal: abnormal temperature perception; Nylon wire for hypoesthesia or disappearance of the foot; Abnormal vibration sense; Ankle reflex disappeared; Two or more nerve conduction velocities were reduced;
5. Have not used mecobalamin, epalrestat, lipoic acid or high-dose glucocorticoid in the recent (3 months) period, or have not been involved in other treatment of the same disease within 3 months prior to the study;

Exclusion Criteria:

1. Neuropathy caused by other causes, such as cervical and lumbar lesions, cerebral infarction, etc.;
2. With acute metabolic complications of diabetes, such as ketoacidosis, lactic acidosis, diabetes hyperotonic state, etc;
3. Severe cardiovascular and cerebrovascular diseases , pulmonary heart disease or pulmonary insufficiency, renal failure, severe dyslipidemia, poorly controlled hypertension, severe hepatitis.
4. Those with a history of malignant tumor or wasting diseases such as tuberculosis;
5. Contraindications to MRI scanning: such as internal (especially oral) metal implants, claustrophobia, etc;
6. Poor compliance or serious side effects;
7. pregnant female.
The Alteration of Macrophage Function in the Spleen Tissues From Patients With Primary Immune Thrombocytopenia

This project was undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to report the alteration on the macrophage function in the spleen tissue of primary immune thrombocytopenia (ITP).


Eligibility Criteria:
Inclusion Criteria:

* adult ITP patients whose platelet counts remain less than 10 x 10\^9/L
* patients whose platelet counts remain less than 30 x 10\^9/L and who continue to experience excessive bleeding after 4 to 6 weeks of appropriate medical treatment
* patients who have experienced a transient response to primary treatment and have platelet counts less than 30 x 10\^9/L after 3 months
* require continuous glucocorticoid therapy to maintain safe platelet counts
* Willing and able to sign written informed consent.

Exclusion Criteria:

* Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
* Current HIV infection or hepatitis B virus or hepatitis C virus infections.
* Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
* Female patients who are pregnant.
* Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
* Patients who are deemed unsuitable for the study by the investigator.
Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA)

This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement.

Inclusion criteria are subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bone defect) covered 1-2 tooth span with adjacent tooth, planned for dental implant and fixed prosthesis, aged 20 and above but under the age of 65 with good physical health and good oral hygiene, able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment and available for follow-up after implant placement.

Exclusion criteria are subjects in following reasons: (i) Heavy smokers (\>10 cigarettes/day), (ii) receiving bisphosphonates, (iii) undergoing radiotherapy, (iv) uncontrolled medical conditions, (v) Alcoholism, (vi) Pregnancy Bone augmentation procedure Before surgery, patients will be premedication with 1000 mg of amoxicillin antibiotic and rinse chlorhexidine mouthwash 0.12% concentration for 1 minute. A single oral and maxillofacial surgeon will perform all surgical procedures. Local anesthesia with 4% Articaine hydrochloride with epinephrine 1: 100,000 (Septanest, Septodont, France) will be administered to each patient for inferior alveolar nerve block or local infiltration. A full thickness mucoperiosteal flap will be created, and the actual defect size will be measured with a periodontal probe following the flap procedure. Flap advancement with periosteal releasing flap, decorticate the bone with a round bur, then apply the semi-rigid shell and fix it with ti-tacks or screws. Following that, xenograft, a bone graft material will be placed, and ti-tacks will be used to fix the semi-resorbable covering membrane. Lastly, tension-free flap closure with double layer suturing technique which is a horizontal mattress and interrupts suture.

Eligibility Criteria:
Inclusion Criteria:

* subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bone defect) covered 1-2 tooth span with adjacent tooth
* Planned for dental implant and fixed prosthesis
* Aged 20 and above but under the age of 65 with good physical health and good oral hygiene
* Able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment.
* Available for follow-up after implant placement.

Exclusion Criteria:

* (i) Heavy smokers (\>10 cigarettes/day)
* (ii) receiving bisphosphonates
* (iii) undergoing radiotherapy
* (iv) uncontrolled medical conditions
* (v) Alcoholism
* (vi) Pregnancy.
Effect of Multiple Subcisions on Rolling Acne Scars

The purpose of this study is to find out whether the use of multiple subcisions over several visits will improve the appearance of rolling acne scars compared to no treatment.

This study was a pilot study designed to determine feasibility of this procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65
2. Have bilateral rolling acne scars on each side of their face
3. No active or ongoing acne.
4. The subjects are in good health
5. The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

1. Under 18 years of age
2. Pregnancy or Lactation
3. Subjects who are unable to understand the protocol or to give informed consent
4. Subjects with mental illness
5. Recent Accutane use in the past 6 months
6. Subjects prone to hypertrophic and keloidal scarring
7. Subjects reporting any blood diseases (HIV, Hepatitis, etc.)
8. Subjects reporting a history of Herpes (oral or genital)
Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

The purpose of this research study is to look at whether there are differences in blood vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels, and levels of other blood markers in women who have had a pregnancy complicated by diabetes as compared with women who have had a normal pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women of self-identified African descent (black) and European (white) ancestry
* 18-40 years of age
* Regular menstrual cycles
* 5 or less years postpartum
* Have either a normal or a GDM index pregnancy history
* Are in good health free of thyroid, cardiac, or renal disease

Exclusion Criteria:

* If you are pregnant
* If you are lactating
Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)

The purpose of this study is to estimate the effect of anakinra, 100 mg once daily (QD), on the development of an anti-tetanus antibody response in subjects with RA after vaccination with a tetanus and diphtheria toxoids injection. In addition, this study will evaluate the general safety profile of therapy with anakinra, 100 mg QD, in subjects with RA after vaccination with a tetanus and diphtheria toxoids injection.


Eligibility Criteria:
Inclusion Criteria: - Diagnosed with RA by American College of Rheumatology (ACR) criteria for greater than or equal to 12 weeks - Active RA with at least 3 swollen joints and 3 tender/painful joints and at least one of the following:

* Morning stiffness greater than or equal to 45 minutes;
* C-reactive protein (CRP) greater than or equal to 1.5 mg/dL;
* Erythrocyte sedimentation rate greater than or equal to 28 mm/hr;
* Stable methotrexate dose of less than or equal to 20 mg/week for 8 weeks prior to randomization;
* Stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to 10 mg/day of prednisone or equivalent) for 4 weeks prior to randomization. Exclusion Criteria: - Pregnant or breast-feeding women - Any uncontrolled, clinically significant systemic disease - Has total white cell count less than 3.5 x 10\^9/L, a neutrophils count less than 2.0 x 10\^9/L, platelet count less than 125 x 10\^9/L or hemoglobin (Hgb) less than 8.0 g/dL at screening - Abnormal liver function tests (AST/ALT greater than or equal to 1.5 x the upper limit of normal at screening) - Serum creatinine greater than 1.5 x the upper limit of normal at screening - Subject recall of having tetanus toxoid or diphtheria vaccination less than 10 years prior to randomization - Has never received a primary tetanus vaccination - Any other vaccination within 12 weeks of randomization - Disease-modifying antirheumatic drugs (DMARDs) other than methotrexate - Biologics to treat RA within the previous 8 weeks of screening (e.g., etanercept, infliximab) - Subjects were treated with anakinra within 4 weeks prior to randomization
Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II Hypertension

This study assessed the efficacy and safety of combination therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in patients with stage II Hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients 18 years of age or older
* Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicidal or an intrauterine device.
* Patients with a diagnosis of hypertension as following msDBP \& msSBP Requirements:

  * For newly diagnosed/untreated patients:

    * Mean Sitting Diastolic Blood Pressure (msDBP) ≥ 100 and \< 120 mmHg, and/or mean sitting Systolic Blood Pressure (msSBP) ≥ 160 and \< 200 mmHg at Visit1.
  * For previously treated patients with 1 or 2 antihypertensive medications:

    * msDBP ≥ 90 and \< 100 mmHg, and/or msSBP ≥ 140 and \< 160 mmHg at Visit 1 AND
    * msDBP ≥ 100 and \< 120 mmHg, and/or msSBP ≥ 160 and \< 200 mmHg at Visit 2.
  * For previously treated patients with Atenolol 50 mg once daily alone more than 2 weeks consecutively at visit 1:

    * msDBP ≥ 100 and \< 120 mmHg, and/or msSBP ≥ 160 and \< 200 mmHg.
* Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Exclusion Criteria:

* Patients that previously participated in any Aliskiren study.
* Inability to receive or completely replace all previous antihypertensive medications with Atenolol 50 mg once daily for a period of 2 weeks as required by the protocol.
* Patients on 1 (other than Atenolol 50 mg once daily) or 2 antihypertensive drugs with msDBP ≥ 100 mmHg and/or msSBP ≥ 160 mmHg at Visit 1.
* Patients on 3 or more antihypertensive drugs at Visit 1.
* Pregnant or nursing (lactating) women, when pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (≥ 5 mIU/mL).
* Sexually active female patients who are not using effective contraceptive methods.
* Serum potassium \<3.5 mEq/L (mmol/L) or \> 5.5 mEq/L at Visit 1.
* Second or third degree heart block with or without a pacemaker, or other potentially life-threatening or symptomatic arrhythmia current or by history.
* History of noncompliance to medical regimens or unwillingness to comply with the study protocol.

Other protocol-defined inclusion/exclusion criteria may apply
B-lactam Databank Algorithm

Background:

Antibiotic allergy constitutes a major health problem with serious medical and financial consequences when under- but also overdiagnosed.

About one and a half million Belgians report having an allergy to penicillin. However, in 1.35 million (90%) of these "penicillin allergies", the suspicion is wrong. The issue of false penicillin allergy is therefore seen as an important medical problem with significant implications for the individual patient but also for society.

Today, therefore, there is a global consensus to contain the pandemic of false penicillin allergy as much as possible. This should ultimately lead to correct antibiotic policies for the patient and reduce antibiotic resistance and the cost to society.

The problem with this is that there is no diagnostic test that one can perform on a population of one and a half million people. This is practically and financially unfeasible. So there is a need for proper risk stratification based on anamnestic data to better guide our diagnostics.

Specific question:

The investigators currently have a database of about 1000 patients with a possible hypersensitivity to antibiotics who have been fully diagnosed according to current guidelines. The aim of the study is to use this database to see whether a tool can be developed to reliably perform an initial "screening" to determine in whom further testing is necessary and in whom, based purely on the story, it can be decided that the likelihood of penicillin allergy is extremely low and additional diagnostics are unnecessary.


Eligibility Criteria:
Inclusion Criteria:

* Adults and minors with a suspected allergy to beta-lactam antibiotics

Exclusion Criteria:

-