cyrilzakka/clinical-trials huggingface dataset:
Controlled Trial: 5-day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus

New antibiotics are required that have antibacterial activity against doxycyline resistant O. tsutsugamushi, that can be safely used in pregnant women and children, that have a low possibility of inducing resistance and that do not induce cross resistant to other antibiotics. Telithromycin has been reported to be effective on Rickettsia, Batonella and Coxiella burnetii. Therefore, telithromycin may be considered as a substitute antibiotic that can be used safely in pregnant women and children for rickettsiosis or Orientia infection. Our study was designed to prove the clinical usefulness of telithromycin by comparing it with doxycycline for treating mild or moderate scrub typhus.

Randomization and treatment assignment. After submitting a written, informed consent, the patients with an temperature of higher than 37.5°C and who met the eligibility criteria were randomly allocated to receive one of two oral regimens in accordance with a protocol that was determined by the last digit of a resident registration number (the patients with an odd number were treated by a5-daycourseofdaily 200-mg doses of doxycycline,and the patients with an even number were treated by a 5-day course of daily 800-mg doses of telithromycin). Therapy was started immediately after acomprehensive clinical examinationand the collection of specimens for laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

We conducted a multicenter prospective study of patients with possible scrub typhus. Adult patients (aged ≥18 years) who have had fever (temperature: ≥37.5°C) together with eschar or a maculopapular skin rash and ≥2 of the following symptoms: headache, malaise, myalgia, coughing, nausea, and abdominal discomfort, were enrolled after obtaining an informed consent from the patients or their guardians (10). Each patient was admitted between September, 2005 to December, 2005 to Chosun University Hospital or one of its two community branch hospitals (Jangheung Hospital and Chumdan Hospital), which are all located in southwest Korea.

Exclusion Criteria:

* The exclusion criteria were an inability to take oral medications, pregnancy, hypersensitivity to the trial drugs, previous drug therapy with potential antirickettsial activity (e.g., rifampicin, chloramphenicol, macrolides, fluoroquinolones or tetracyclines) within 48 h prior to admission, severe scrub typhus (shock requiring vasopressor therapy for \>1 h, a stuporous or comatose level of consciousness, respiratory failure requiring mechanical ventilation or renal failure requiring immediate dialysis)
Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.

The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.

The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.

We will conduct a clustered controlled before and after study (CBA) in the Netherlands that compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five hospitals) will focus on change at the patient, professional and organizational levels. Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care.

A stepwise approach will be followed:

Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and facilitators for implementation, via a qualitative study with patients (four focus groups n = 10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per hospital).

Step 2: Selection and development of interventions to create a PD and MF strategy during expert's roundtable discussions, using the knowledge gained in step 1 and a literature search of the effect of strategies for implementing PCRPs.

Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process evaluation and costs), by data extraction from existing registration systems, questionnaires and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per hospital. For the process evaluation, n=50 patients, 5 per hospital, and n = 40 healthcare professionals, 4 per hospital.

Eligibility Criteria:
Inclusion Criteria:

patients:

* preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases.
* Adults
* Diagnosed in one of the participating hospitals
* Able to read and understand Dutch

Healthcare professionals:

• involved in cancer care in one of the participating hospitals
The Role of CYP2C19 on the Eradication of H. Pylori Infection:Implication of PK/PD Relationships

The objective of this trial is to find the rationale and the optimal dose and duration of regimen for the eradication of H. pylori infection using different proton pump inhibitors.

Helicobacter pylori in known to be closely associated with the pathogenesis of gastroduodenal disorders such as peptide ulcer. Eradication of this bacterium is important in the treatment of these diseases as well as in the reduction of the recurrence. The one-week triple therapy with proton pump inhibitors (PPIs) is now considered to be the standard therapies in the treatment of Helicobacter pylori infection, providing more than 80% eradication rates with few adverse effects. PPIs are mainly metabolized by CYP2C19, which is known to exhibit polymorphisms in both its genotype and phenotype. Based on the PK/PD results of our study on PPI, recently, we have proposed that CYP2C19 poor metabolizers might be subject to advantageous conditions, especially after day-4, for the treatment of H. pylori infection when 20 mg rabeprazole was given twice daily. Our results also suggest a possibility to start the triple therapy on day-4 of rabeprazole treatment to ensure the optimal acid suppression effect for antibiotics to exert the bacteriocidal effect. To find the rationale and the optimal dosing regimen for the eradication of H. pylori infection using different proton pump inhibitors, volunteers of four groups would be included in this study. PPI (rabeprazole or esomeprazole) is given for 7 days. Antibiotics are given starting from day-1 or day-4 of PPI dosing. The eradication rate of H. pylori infection and the PK/PD of PPIs are also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male and female dyspeptic patients with H. pylori-positive peptic ulcer or gastritis will be recruited at the university hospital in this study.

Exclusion Criteria:

* 1)Pregnant or lactating female;\*2)Patients have endoscopy-based evidence of gastric malignancy, pyloric obstruction, and esophageal stricture requiring dilation, fresh clot, active bleeding, or perforated ulcers;3)Patients requiring anticoagulants or corticosteroid therapy (at dosages greater than the equivalent of prednisone, 10 mg/day);4)Patients with significant impairment of renal function (creatinine\>2mg/dl); liver function impairment (AST and ALT 2x upper limit of normal); severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV) or acute respiratory disease;5)Patients with a history of esophageal and/or gastric varices;6)Use of other investigational drugs within 30 days prior to the study.
Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants

The purpose of this randomized and placebo-controlled EpoRepair trial is to evaluate the effect of intravenously administered recombinant human erythropoietin (Epo) as compared to placebo in preterm infants with brain damage on neurological development until five years od age.

Worldwide, 1% of all infants are born very preterm with less than 32 weeks of gestation, which is more than 2 months before expected date of delivery. If these smallest infants suffer in addition to prematurity a second hit, such as intraventricular hemorrhage or parenchymal infarction, they are at high risk for learning disabilities, mental retardation, and cerebral palsy in later life.

Intraventricular hemorrhage and parenchymal infarction occur in about 12% of very preterm infants, mostly in the very smallest and within the first few days after birth, and can be recorded by cranial ultrasound. Except for shunt insertion to divert cerebrospinal fluid in infants with posthemorrhagic hydrocephalus and possibly the removal of blood clots, there is no treatment for established intracerebral bleeding, and no medical therapies exist to ameliorate the neurodevelopmental sequelae.

Apart from stimulating production of red blood cells in the bone marrow, recombinant human erythropoietin (Epo) has been shown to exert neuroprotective action in a variety of animal models and in clinical studies. Epo administration has been found to be beneficial and safe in randomized controlled trials (RCT) involving adult and infant patients.

Observational data suggest that Epo administered to very preterm infants in order to prevent from anemia improves long-term cognitive outcomes until school-age especially in those infants who had suffered intracerebral bleeding. These data, however, are observational and therefore do not allow for any firm conclusions or recommendations. The hypothesis generated by these data calls for confirmation or refutation by an RCT designed to address this question.

Eligibility Criteria:
Inclusion Criteria:

1. Infants with less than 32 weeks of gestation and/or less than 1500 g weight at birth
2. Intraventricular hemorrhage and/or hemorrhagic parenchymal infarction
3. Less than 8 days of life
4. Informed written parental consent

Exclusion Criteria:

1. Genetically defined syndrome
2. Severe congenital malformation adversely affecting life expectancy and/or neurodevelopment
3. A priory palliative care
4. Unlikely to participate at 5-year follow-up examination
Comparison of Perfusion Index Monitoring Using a Smartwatch and a Pulse Oximeter

The aim of the study is to experimentally compare measured perfusion index values between smartwatch and a medical grade pulse oximeter in healthy subjects at rest and with and without motion artifacts and during exercise.

Perfusion index (PI) is one of the many vital signs monitored to assess the clinical status of a patient. PI is determined from the pulsatile part of the plethysmographic curve, with typical values measured on the fingers ranging from 0.02% to 20%. Although PI is a relatively newly measured parameter, it has already found application in many areas of clinical medicine. For example, continuous measurement of the perfusion index has been used to monitor changes in finger blood flow after finger replantation (surgical reattachment of the finger to the patient's body). As the ability to monitor the perfusion index begins to become part of the monitored parameters of smartwatches, this new feature could be used in situations where the use of finger sensors is not appropriate. However, no comparison of perfusion index measurements between smartwatch and pulse oximeter has been made to date.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult Volunteer

Exclusion Criteria:

* Post-traumatic upper limb conditions affecting finger or arm perfusion
* Injuries or diseases of the skin of the fingers and arm
* Any acute phase of any disease
Evaluation of Photodynamic Therapy in Pieces With Presence of Fistula.

The goal of this clinical trial is to learn if adjuvant antimicrobial photodynamic therapy (aPDT) can help in the treatment in patients with pieces with apical periodontitis and the presence of fistula, in terms of reducing symptoms, resolution of fistula and the clinical signs of inflammation at the oral mucose, as well as, evaluation radiographic parameters.

Participants will undergo conventional endodontic treatment at Group I (n=15) and will undergo conventional endodontic treatment combined with antimicrobial photodynamic therapy at Group II(n=15).

The calculation of the sample size was conducted with the statistical software G-Power 3.1 applying the chi-square homogeneity test. Identical sample sizes were considered for the aPDT group and the sham group. The percentage of type error was set at 5% and the statistical power at 80%, obtaining n = 30 considering 10% losses. The distribution of data within each group and the homogeneity of the variants will be verified for the choice of an analysis of variance or not. With this information the most proper statistical test will be conducted. The sample size calculation is based on the literature and a 5% significance level will be adopted

Eligibility Criteria:
Inclusion Criteria:

Patients must have a single-rooted tooth with apical periodontitis and the presence of fistula.

Patients must be over 18 years of age.

Exclusion Criteria:

Patients with comorbidities such as cancer, diabetes, coagulation diseases, and anemia; Patients undergoing orthodontic treatment; Patients with periodontal pockets deeper than 4 mm; Patients taking antibiotics; Pregnant or lactating patients; Patients with parts that present the impossibility of performing absolute isolation.
Cerebral Dysfunction in Chronic ITPwith High Risk of Serious Bleeding Excluding Intracranial Hemorrhage.

Intracranial hemorrhage despite being rare, several chronic ITP patients experience moderate to severe behavioral problems including learning difficulties, memory affection .These changes could be due to the presence of minute capillary dysfunction

* First identify the presence of cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP and correlate these changes with radiological evidence of minimal CNS bleeding.
* Second investigate the correlation between these behavioral and/or minimal neurological deficits and duration, site and severity of bleeding (a total of 200 patient of persistently low platelet count \< 20x 10 9 for at least more than one month duration).
* The aim is to assess the behavioral changes in chronic ITP patients, and to assess the possible relation of such changes to duration and recurrence of very low platelet count as well as pattern of bleeding excluding frank intracranial hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic ITP patients with persistent platelet count \< 20 x 109/L for a period more than one month.
2. Chronic ITP with more than one attack of wet purpura and OR internal bleeding.

Exclusion Criteria:

1. Patients' with platelet count persistently more than 40 x 109/L.
2. Past history of intracranial hemorrhage.
3. Past history of known neurological or psychological deficit diagnosed before onset of ITP diagnosis
Outcome EnduRo Versus LINK SL Rotating Hinge Knee

Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery. Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters


Eligibility Criteria:
Inclusion Criteria:

* rotating hinge knee indicated

Exclusion Criteria:

* infection,
* malignant tumor,
* rheumatism
Imaging of Arthropathy in Boys With Hemophilia in China

Hemophilia is a genetic condition characterized by marked phenotypic heterogeneity. Bleeding into a joint is the single most important risk factor for the development of hemophilic arthropathy (HA). It is thought that clinical and imaging manifestations of HA are at least partially attributable to genetic polymorphisms unrelated to the hemophilia genotype. Identifying and characterizing biologic factors that could explain differences in susceptibility to joint degeneration of patients with hemophilia would help stratify patients according to the risk of degeneration of their joints and develop personalized therapeutic and prophylactic strategies. This study is conducted in China.

This will be a 3-year prospective cohort study conducted in a single centre (Beijing Children's Hospital, BCH, China) with a 2-year follow-up of patients Index joints (ankles, elbows and knees) of young Chinese boys with hemophilia A will be evaluated as follows: physical examination every 6 months using the Hemophilia Joint Health Score \[HJHS\], ultrasound imaging (gray-scale and color Doppler ultrasound \[US\]), and by laboratory (serum) at baseline, at 6, and 24 months. Magnetic resonance imaging (MRI) scans of index joints will be obtained at baseline, and 24 months. Features that will be captured either quantitatively or semantically in the imaging scans will be aggregated to generate "imaging phenotypes" which will be associated with clusters of co-expressed genes (metagenes) and clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Hemophilia A with baseline FVIII levels of \<2%
* Clinical history of ≥ 50 exposure days to FVIII prior to the study start.
* On-demand treatment, prophylaxis FVIII infusions or treatment with plasma-derived products for \>3 months prior to enrollment into the study.

Exclusion Criteria:

* History of FVIII inhibitor (titer \>0.6 Bethesda Units \[BU\])
* Chronic renal failure (serum creatinine \>2.0 mg /dL).
* Chronic liver disease (alanine aminotransferase \[ALT\] \>200 U/L).
* Clinically documented immunodeficiency.
* Anticipation of need for major surgery during the study period.
* Association of diseases known to mimic or cause joint diseases such as symptomatic human immunodeficiency virus (HIV) infection, juvenile idiopathic arthritis, and metabolic bone diseases.
* Social barriers for participation in the study such as long distance between home and the comprehensive care centre, and documented track record of non-compliance to therapies or participation in clinical studies.
* Neuro-developmental/behavioral problems.
* Contraindications to MR imaging (presence of heart pacemakers, metallic foreign bodies in the eye, aneurysm clips, severe claustrophobia).
A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (iCOOL 1)

Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. The RhinoChill (BeneChill, USA) is a new device. A comparison of these two induction methods has never been done before. Neither was the effect of cold infusions on brain-temperature measured. For the first time iCOOL 1 compares feasibility, safety and efficacy of the two methods.


Eligibility Criteria:
Inclusion Criteria:

* Sedation, intubation and mechanical ventilation
* Combined ICP-temperature-probe
* Indication to lower body temperature
* Age ≥ 18 years

Exclusion Criteria:

* Body weight \> 120 kg
* Fever \> 38.5°C
* Chronic sinusitis
* Current or past fracture or surgery of the paranasal sinuses
* Severe infection with bacteremia or sepsis ≤ 72 h
* Severe renal insufficiency
* Severe liver insufficiency
* Acute pulmonary embolism
* Acute myocardial infarction
* Severe cardiac insufficiency (NYHA ≥ III)
* Threatening ventricular dysrhythmia
* Cardiac dysrhythmia with bradycardia (heart rate \< 50 /min, QTc \> 450 ms, sick sinus syndrome, AV-block II-III°).
* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
Antipsychotic Medication Extended Dosing Study

In patients stabilized on their antipsychotic and demonstrating evidence of good clinical response, there will not be a significant change in symptoms if their medication is decreased to every 2 days rather than daily. This decrease in antipsychotic exposure will lead to a reduction in side effects, as well as improved subjective response to treatment.

The present study is a 6-month, double-blind study of patients with schizophrenia stabilized on their current antipsychotic (monotherapy) for a period of at least 3 months. After providing informed consent, individuals will be randomly assigned to 1 of 2 treatment arms: regular daily antipsychotic dosing or active medication at the same daily dose every 2nd day. Various scales to measure clinical response and side effects will be administered at baseline, as well as every 2 weeks thereafter. Subjective scales will also be employed, and lab evaluations will include plasma antipsychotic levels at baseline and endpoint, as well as prolactin. Our sample size will be 20/group.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizo-affective disorder
* Capacity to provide written, informed consent
* Stabilized\* on a single oral antipsychotic for at least three months (excluding CLOZAPINE or QUETIAPINE)
* Evidence of compliance with previous antipsychotic treatment, i.e. greater than 90% \* defined as 2 consecutively identical CGI evaluations (screening and baseline, at least one week apart)

Exclusion Criteria:

* exposure to depot antipsychotic during 12 months prior to enrollment
* substance-related disorders according to DSM-IV