cyrilzakka/clinical-trials huggingface dataset:
Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination

To evaluate the anti-bacterial, pre-procedural, clinical efficacy of Peroxyl mouthwash (1.5% hydrogen peroxide) in saliva and the reduction of bioaerosol contamination as compared to a matching placebo mouthwash (0.0% hydrogen peroxide)

Qualified subjects will be enrolled and randomized to either one of the two study groups, balanced on the basis of their initial gingival index scores. Saliva samples will be collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. Saliva samples will again be collected immediately after, at 30 min, and 60 min after rinsing. All collected saliva samples will be placed in sterile vials, labeled with subject information and transferred to the microbiology laboratory for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must meet ALL of the following criteria:

  * Subjects, ages 18-70, inclusive.
  * Availability for the duration of this clinical research study.
  * Good general health.
  * At least 20 natural teeth.
  * Gingivitis Index 1.0 (Löe-Silness).
  * Signed Informed Consent Form

Exclusion Criteria:

* Potential subjects must NOT HAVE ANY of the following conditions:

  * Symptoms consistent with COVID-19 or have tested positive.
  * Presence of orthodontic bands.
  * Tumor(s) of the soft or hard tissues of the oral cavity.
  * Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) or peri-implantitis.
  * Five or more carious lesions requiring immediate restorative treatment.
  * Use of antibiotic one-month prior to entry into the study.
  * Participation in any other clinical study or test panel within the one month prior to entry into the study.
  * Dental prophylaxis during the past two weeks prior to baseline examinations.
  * History of allergies to oral care/personal care consumer products or their ingredients.
  * On any prescription medicines that might interfere with the study outcome.
  * An existing medical condition that prohibits not eating or drinking for periods up to 4 hours.
  * History of alcohol or drug abuse.
  * Self-reported pregnant or lactating subjects.
Assessment of International Normalized Ratio (INR) Prolongation in Patients Treated Simultaneously With Warfarin and Cephalosporins

Many drug interactions with Warfarin are well documented in the literature, including interactions with a variety of antibiotics. However,in mamy cases it is difficult to predict when the interaction remains theoretical and when it becomes clinically significant and will be reflected in the individual patient. This study's aim is to identify and characterize related conditions (including comorbidities, laboratory test results and other parameters related to the patient)that might be predictors for drug interactions turning from theoretical to clinically significant.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over
* Patients treated with a combination of Warfarin and Cephalosporins
* Patients who were hospitalized in the department of internal medicine
* Patients who were treated with Warfarin without Cefalosporins

Exclusion Criteria:

* Patients on Warfarin who did not actually receive the drug during their hospitalization
* Patients whose medical records were not accessible or didn't contain full data
Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.

This study compared the effects of mechanical and manual traction on pain, disability and lumbar spinal curvature in patients with discogenic low back pain


Eligibility Criteria:
Inclusion Criteria:

* Patients with discogenic low back pain,
* Patients of both genders
* Age ranges from 20 to 60 years
* NPRS \> 5

Exclusion Criteria:

* Patients with non-mechanical back pain
* Patients with known metabolic diseases,
* Osteoporotic patients,
* Recent history of spinal trauma or surgery,
* Lumbar myelopathy,
* Cauda equine syndrome.
Correlation Between RISANKIZUMAB's Trough Levels, Clinical and Biological Remission in Moderate to Severe Crohn's Disease: a Retrospective Multicentric Study

The goal of this observational study is to determine if, as with other therapeutics such as anti-TNF, trough levels of Risankizumab are correlated with clinical and biological remission in patients with moderate to severe Crohn's disease. As part of their regular biological surveillance, trough levels of Risankizumab were mesured and clinical and biological data were collected to determine if biological and clinical remission criteria were met.

The treatment of chronic inflammatory bowel disease has undergone a number of therapeutic revolutions in recent years, with the emergence of new biotherapies. These include RISANKIZUMAB, an anti-IL23 p19, whose ADVANCE , MOTIVATE and FORTIFY studies have demonstrated its efficacy in the induction and maintenance phases of Crohn's disease. Reimbursement in France for this indication is expected in the final quarter of 2024.

While for first-line molecules such as anti-TNF alpha, the relationship between serum levels and clinical remission is accepted and allows to guide the therapeutic strategy for patients, it has yet to be demonstrated for new molecules of interest.

We enrolled patients with moderate to severe Crohn's disease on Risankizumab in four centers. Trough levels of Risankizumab were mesured as a part of their regular medical surveillance routine. For each consultation, biological and clinical data were collected to determine wether patients were in remission (according to our primary outcome) or not. Data were collected up to 18 months since the introduction of Risankizumab.

The objectives of this study were also to identify factors of primary or secondary failure of treatment, to determine clinical reponse rate, to evaluate tolerance and persistence of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients with moderate to severe Crohn's disease
* Failure of at least one immunosuppressant and one anti-TNF alpha agent
* Patients on Risankizumab
* No opposition to study participation

Exclusion Criteria:

* Age \< 18 years
* UC
* Unclassified colitis
* Risankizumab prescribed to prevent post-operative relapse
* Any contraindication to Risankizumab
* Refusal to participate in study
Bioavailability of BIBR 953 ZW After Administration of BIBR 1048 MS in Healthy Subjects

Study to assess the amount of BIBR 953 ZW in urine and concentrations in plasma after administration of 50 mg of BIBR 1048 bid over three days each administered as two experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP and local legislation
* Age ≥ 18 and ≤ 55 years
* BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of relevant orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after a car accident)
  * commotio cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl
Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML

A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.

This will be an open label, multicenter study of subcutaneous HHT (omacetaxine mepesuccinate) therapy of patients with chronic myeloid leukemia (CML) in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy. Patients will be treated with induction course cycles consisting of subcutaneous (SC) HHT 1.25 mg/m² twice daily for 14 consecutive days every 28 days. Patients will be evaluated every 7 days with complete blood and platelet counts while undergoing induction therapy; the number of consecutive doses of HHT or intervals between subsequent cycles may be adjusted, as clinically indicated, according to guidelines provided in the treatment plan.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, age 18 years or older
* Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase
* Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response).
* Acceptable Renal and Liver Function
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Sexually active patients and their partners must use an effective double barrier method of contraception

Exclusion Criteria:

* New York Heart Association classification (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition
* Myocardial infarction in the previous 12 weeks.
* Other concurrent illness which would preclude study conduct and assessment
* uncontrolled and active infection, and positive HIV or positive HTLV I/II status, whether on treatment or not.
* Pregnant or lactating.
* Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.
* Lymphoid Ph+ blast crisis
* Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent
Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.

A long-term follow-up study to assess safety and efficacy in patients previously treated with Mustang Bio chimeric antigen receptor (CAR)-T cell investigational products.

Non-interventional, multi-center, long-term follow-up study of subjects previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study. Subjects who enroll will be monitored for a total of up to 15 years from the time of their last investigational product infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients previously treated with a Mustang Bio CAR-T cell investigational product in a prior Mustang Bio sponsored clinical study.
* Patient has provided signed and dated informed consent.

Exclusion Criteria:

* None. All patients who have received prior treatment with Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study are eligible for this long-term follow up (LTFU) study.
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients

The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients.

The secondary objective is to get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertensive patients
* Moderate to severe Patients with uncontrolled blood pressure (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg for untreated, systolic blood pressure ≥150mmHg, diastolic blood pressure ≥95mmHg for treated on monotherapy).
* Patients are willing to discontinue previous antihypertensive medicine

Exclusion Criteria:

* Pregnant or lactating women, or women of child bearing potential without contraceptive method.
* Hypersensitivity to any component of the products or other sulfonamide derived substances.
* Secondary hypertension.
* Severe renal impairment (Creatinine Clearance ≤30ml/min)
* Severe hepatic impairment, biliary cirrhosis and cholestasis.
* Refractory hypokalemia, hypercalcaemia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Risk of Recurrent CeAD After Pregnancy

Primary objective: To determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data.

Methods: Multicentric, observational case-control study based on pooled individual patient data from several stroke centers.

Primary endpoint: Primary composite outcome measure includes the following outcomes: (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death.

Background: Cervical artery dissection (CeAD) is a leading cause of stroke in women of childbearing age. Among the population with an initial CeAD, about 9% show a recurrence event (a range from 0 to 25% has been reported). Recurrence of CeAD can occur for several years after the initial event. CeAD has been shown to occur in association with pregnancy, and the postpartum period, yet it remains unclear whether pregnancy increases the risk of recurrence or delayed stroke. Previous studies on this subject are either based on small sample sizes or lack long-term data.

Objective: The investigators want to determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data.

Furthermore, it will be investigated whether the mode of delivery affects recurrence and if dissections occurred during a particular phase of a woman's reproductive process. The investigators will also investigate if women actively decided against another pregnancy due to the initial CeAD.

Methods: This study will be a multicenter, exploratory case-control study using pooled individual patient data from several stroke centers. The data will be obtained through review of medical records and patient interviews. The study will include all women with any prior CeAD who have had long-term follow-up (at least 6 months, with no upper limit), including information about pregnancy and recurrence of CeAD.

Primary endpoint is a composite outcome measure which consists of (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death. Secondary endpoints are the individual components of the primary endpoint and functional outcome assessed by the modified Ranking scale.

Statistical analysis will be used to determine the odds of the primary and secondary endpoints in women who had subsequent pregnancies compared to those who did not.

Eligibility Criteria:
Inclusion Criteria:

* female
* prior symptomatic cervical artery dissection (= index CeAD)
* at least one long-term follow-up visit (at least 6 months after the initial event)
* with information available on outcome events:
* recurrent dissection
* ischemic stroke
* hemorrhagic stroke
* functional outcome assessed by mRS score
* with data on pregnancy after the initial event
* at least 18 years old at the initial event

Exclusion Criteria:

* Male patients
* Age \<18 years
* No long-term follow-up available or long-term follow-up \< 6 months after initial event
* No data on pregnancy after initial event available
Mantra Meditation in Major Depression

To evaluate effects of mantra meditation on depressive symptoms if applied as adjunctive therapy to psychotherapy and/or antidepressant drugs and to explore if meditation leads to increased spirituality as a potential mediating factor of positive mental health.

Primary objective To measure the difference in efficacy between treatment as usual (TAU) + Mantra meditation (MAM) 20min per day and TAU + progressive muscle relaxation (PMR) 20min per day in the treatment of depressive symptoms in patients with Major Depression after inpatient treatment, after 3 months and after 6 months of treatment as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).

Secondary objectives (exploratory)

1. Differences between and within groups in self-rated depression, rumination, automatic negative thinking or trait-anxiety.
2. Differences between and within groups in measures of spirituality.
3. Correlation between measures of spirituality and change of psychometric scores.
4. Change in stress response and relaxation response after inpatient treatment, compared to baseline.
5. Difference in adherence and depth of practice between groups and within groups and correlation to psychometric outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Inpatients of open psychiatric ward
2. Written informed consent by patients who are competent to consent to study participation
3. Diagnosis of current episode of major depression as defined by DSM-IV criteria and diagnosed via structured interview (SKID) by a trained psychiatrist or psychologist. DSM-IV codes: 296.22, 296.23, 296.32, 296.33. Corresponding ICD-10 codes: F32.1, F32.2, F33.1, F33.2.
4. Male or female ≥18 years of age
5. BDI-II \>= 20
6. Patients must be able to sit in a chair for at least 20 minutes
7. Patients live in the catchment area of the hospital

Exclusion Criteria:

Patients will be excluded for ANY ONE of the following reasons:

1. Any other current major psychiatric disorder is an exclusion criterion EXCEPT for the following:

   * Abuse of nicotine or dependence of nicotine;
   * Agoraphobia with or without Panic Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder, Specific Phobia, Social Phobia
   * Hypochondriasis, Pain Disorder, Somatization Disorder, Undifferentiated Somatoform Disorder
   * Sexual and Gender Identity Disorders
   * Eating disorders
2. Psychotic symptoms that are not compatible with diagnosis of unipolar depression
3. Acute suicidality
4. Diagnosis affecting cortisol levels such as type I diabetes mellitus, cancer, asthma, chronic hepatitis, chronic fatigue syndrome, or regular use of medications having an immuno-modulary effect (e.g. cytotoxic chemotherapy, corticosteroids, interferons);
5. Current practice of other forms of Mantra repetition such as the rosary, chanting, or Transcendental Meditation
6. Current participation in another trial
Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies

The aim of the study is to establish and identify the level of sedation that is performed in the endoscopy rooms of Galdakao Hospital. To do this, the investigators used the BIS monitoring system, which obtains objective values in real time from the anesthesia performed. The monitoring is completed with basic parameters validated by European guidelines (heart rate, blood pressure, oxygen saturation and respiratory rate), capnography and Ramsay sedation scale, widely validated for use outside the operating room. The main work hypothesis was that in at least 10% of the patients BIS values compatible with moderate or deep sedation would be obtained (BIS \<65).

Observational study in patients undergoing scheduled colonoscopy in endoscopy rooms of the Galdakao-Usansolo Hospital. The investigators objectified the level of sedation that was performed in these procedures using Bispectral Index Monitoring, as well as the total dose of medication required and the level of satisfaction obtained after completing the sedation. The incidence of hemodynamic and respiratory complications observed was included, as well as the treatment needed to solve them.

A total of 196 patients were needed to obtain statistically significant results. Qualitative variables are expressed in the form of freguencies and percentages and continuous variables in the form of means and stnadard deviations. Comparisions of percentages were made by the Chi square test and the difference of means in the continuous variables by the t test.Stadistical significance will be assumed when p\<0.05. All estadistical analyzes were carried out using SAS V9.4 (SAS Institute, Inc., Carey, NC).

Eligibility Criteria:
Inclusion Criteria:

* Indication of scheduled colonoscopy.
* Classification of physical status ASA I, II and III.
* Intermitent or persistent mild asthma.
* Body Mass Index (BMI) \< 35 kg/m2.
* Intact neurological capacity.
* Acceptance to participate in the study after signing written informed consent.

Exclusion Criteria:

* ASA IV.
* BMI \> 35 kg/m2.
* Allergy to any of the medications using in sedation, or its components.
* Known mental or neurological disease.
* Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sleep Apnea.
* Chronic opiate users.
* Refusal to participate in the study.
The Effect of Probiotics on the Improvement of Digestive Function and Well-being in the Elderly

To evaluate the effectiveness and safety of the use of probiotics as food supplements compared to placebo in improving digestive function and well-being in older adults.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age is 55-70 years; 2) Willing to undergo 3 follow-up visits during the intervention period; 3) Willing to provide 2 blood, urine, and stool samples during the intervention period; 4) Willing to self-administer Pediococcus acidilactici PA53/placebo once daily during the intervention period; 5) Good eyesight, able to read and write, and can wear glasses; 6) Have good hearing and be able to hear and understand all instructions during the intervention.

Exclusion Criteria:

* 1) Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease); 2) Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia); 3) Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder; 4) Take medication for depression or low mood; 5) Suffering from internal organ failure (heart, liver, or kidney failure, etc.); 6) Radiotherapy or chemotherapy in the past; 7) Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial; 8) Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past; 9) Have taken Pediococcus acidilactici PA53 within the past 3 months.