cyrilzakka/clinical-trials huggingface dataset:
High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study

Tuberculous meningitis (TBM) is the most severe form of tuberculosis infection with high mortality. Current treatment regimens are not based on clinical trials. Rifampicin is a key drug for TBM, but its penetration into the brain is limited, suggesting that a higher dose may be more effective.

There are several highly relevant, outstanding questions related to the appropriate dose of rifampicin for TBM, before a multicenter phase 3 trial can be performed. These are:

1. Previous phase 2a randomized clinical trial (done in the same setting as this proposed study) suggests that high doses of intravenous rifampicin (600mg, circa 13 mg/mg) for TBM is safe and associated with a survival benefit in adults. Given that i.v. rifampicin is not readily available, this needs to be confirmed using an equivalent higher oral dose of rifampicin.
2. Recent pharmacokinetic analysis of a continuation trial comparing 600 mg i.v. rifampicin with 750 mg and 900 mg oral rifampicin suggests that an even higher dose may be needed; but this has not been examined
3. Based on those previous data, there is a need to explore a longer duration of high-dose rifampicin for a subsequent phase 3 randomized clinical trial; treatment response in the investigators previous trial suggest that the optimal duration may be \> 14 days.
4. There is a need to explore relevant treatment endpoints besides mortality including neurological, neuroradiological and inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, aged 15 years or above.
2. Clinical suspicion of TBM and CSF/blood glucose ratio \< 0.5.
3. None or less than 3 days of anti-tuberculosis chemotherapy taken for the current infection.
4. Patient or representative (if the patient is incapacitated) is willing and able to give informed consent for participation in the study.
5. Willingness to allow storage of specimens.

Exclusion Criteria:

Patients may not enter the study if any of the following apply:

1. Liver dysfunction (ALT \> 5 times upper limit); kidney dysfunction (eGFR \< 50 ml/min)
2. Pregnancy or breastfeeding (negative urine pregnancy test for all females of child-bearing age).
3. Confirmed cryptococcus meningitis (LFA), or confirmed bacterial meningitis (microscopy).
4. Rapid clinical deterioration at time of presentation (e.g. signs of sepsis, decreasing consciousness or signs of cerebral oedema, or herniation)
Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects

The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Men and women (not of child bearing potential) ages 18 to 45
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Women of child bearing potential
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis

The aim of the study is: to evaluate the efficacy of two post-operative dressings in the management of the surgical wounds in patients who received a knee prosthesis

This was a randomised, controlled, clinical trial on patients who received a primary knee prosthesis in 2018-2019. Treatment group was given a multi-layer foam dressing with Safetac. The control group received standard treatment with povidone-iodine and a gauze dressing with plaster. 50 patients was needed for sufficient power. Primary outcome measures were; the characteristics of the surgical wound, patient reported comfort and adaptability according to the physiotherapist. Secondary outcome measures were: the clinical status and quality of life level according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Statistical analysis was performed by using IBM SPSS version 25, with a statistical significance of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Surgical intervention of total primary knee prosthesis
* Informed consent approved and signed by participants.

Exclusion Criteria:

* Sensitivity or allergy to study dressings
Breethe Abiomed Recovery RegisTry (BART)

The BART Registry intended to utilize observational data of the Abiomed Breethe OXY-1 System™ in real-world settings to drive best practice usage patterns, serve as a tool to measure and improve the quality of patient care and as a resource to inform us on the design of future studies.


Eligibility Criteria:
Inclusion Criteria:

* all adult subjects supported with Breethe Oxy-1 System

Exclusion Criteria:

* subjects under 18 years of age
Comparison of Biologicals in Treatment of Severe Asthma

This is a retrospective clinical study on adult patients (18 years or more) with biological therapy for severe asthma at the Helsinki University Central Hospital (HUCH). This is a real-life study with a broader patient population than in a randomized controlled trial. Omalizumab has been used for treatment of asthma in HUCH since January 2009, anti-IL5 therapies starting with mepolizumab since April 2016.

The investigators collect and analyse results of anti-IL5/IL5R and anti-IgE therapies in asthma until October 2019.The investigators compare number of exacerbations, number of glucocorticoid courses, dose of per oral glucocorticoid, number of antibiotic courses, need of emergency care and hospitalizations because of asthma before use of biologicals and at the latest visits of the participants when using biologicals.

Eligibility Criteria:
Inclusion Criteria:

* asthma that remains uncontrolled despite moderate to high dose inhaled corticosteroid and additional therapy with at least one other controller medication and need for continuous per oral corticosteroids (OCS) or contraindications (or clinically significant side effects of OCS) against OCS and/or frequent courses (two or more per year) of OCS

Exclusion Criteria:

* patients without asthma
EF5 in Treating Patients With Solid Tumors

Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. This phase I trial is studying how well EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery

PRIMARY OBJECTIVES:

I. Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal signal-to-noise ratio in patients with solid tumors.

II. Determine the toxic effects of EF5 in this patient population. III. Determine the pharmacokinetics of EF5 in this patient population. IV. Determine the dose of EF5 that provides a mean signal-to-noise ratio (maximum binding in anoxia to minimum binding) of 75.

V. Determine the relationship between tumor oxygenation by EF5 binding and needle electrode measurements.

VI. Compare the levels of EF5 binding in regions of low and high blood flow.

OUTLINE: This is a dose-escalation study.

Patients receive etanidazole derivative EF5 IV over 1-2 hours beginning approximately 24 hours prior to surgery. Tumors are then resected or biopsied after Eppendorf needle electrode measurements.

Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose (MTD) or optimal dose is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity. The optimal dose is defined as the dose level at or below the MTD and results in a signal-to-noise ratio of 75 or greater. Thirty additional patients are treated at the optimal dose.

Patients are followed at 30-45 days post EF5 infusion.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed tumor or highly suspicious cancerous mass based on imaging and clinical signs but not indicative of a direct biopsy/cellular diagnosis preceding surgery
* Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection
* Performance status - ECOG 0-2
* Life expectancy not specified
* WBC greater than 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Bilirubin less than 2.0 mg/dL
* Creatinine less than 2.0 mg/dL
* Creatinine clearance greater than 50 mL/min
* No significant cardiac disease that would preclude the safe use of general anesthesia
* No significant pulmonary disease that would preclude the safe use of general anesthesia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after study
* No history of grade III or IV peripheral neuropathy
* See Disease Characteristics
Surgical Resection Versus Percutaneous Local Ablative Therapy for Hepatocellular Carcinoma

The aim of this study is to compare the operative complication and short-/long-term therapeutic effects of percutaneous local ablative therapy (PLAT) versus surgical resection(SR) on small hepatocellular carcinoma(HCC) patients with clinically significant portal hypertension(CSPH) so as to lend clinical and theoretical basis of the therapeutic schemes for the disease.

HCC is a major health problem worldwide, with an estimated incidence ranging between 500,000 and 1,000,000 new cases annually. It is the fifth most common cancer in the world and the third most common cause of cancer-related death,especially in East-Asia countries.SR remains the first therapeutic option for a cure but is suitable only for 9%-27% of patients.The presence of significant background cirrhosis often precludes liver resection for HCC.Even though these HCC patients undergo SR，the incidence of posthepatectomy liver failure(PHLF) and death would be high，especially to HCC patients complicating CSPH，whose corresponding risk of PHLF and persistent PHLF were 59.02%and 14.75%respectively in our past study. It is extremely urgent to search a safe and effective means in this subgroup of HCC patients.PLAT, a recently developed local ablative technique, has attracted the greatest interest and popularity because of its effectiveness and safety,with a 3-year survival rate of 62-77%,a low treatment complication rate of 8-9% and a low treatment mortality rate of 0-0.5%.However, there is still debate on whether PLAT or SR is the most suitable therapy for HCC.To our knowledge,there have been no study on the therapy of HCC complicating CSPH.

Eligibility Criteria:
Inclusion Criteria:

1. 18 Years \< ge ≤ 70 Y,KPS ≥ 70
2. A solitary HCC ≤ 5cm in diameter,or multiple HCC(≤3) ,each ≤3cm in diameter without evidence of radiologically definable vascular invasion or extrahepatic metastasis. allowing to both SR and PLAT
3. Child-Pugh class A or B,without history of encephalopathy,ascites refractory to diuretics,or variceal bleeding
4. NO previous treatment of HCC
5. Platelet count\>40,000/mm3；prothrombin time prolongation of no more than 3 seconds
6. Patients who can understand this trial and have signed information consent

Exclusion Criteria:

1. metastatic liver cancer
2. Patients with apparent cardiac,pulmonary,cerebral and renal dysfunction,which may affect the treatment of HCC

3) Patients with other diseases which may affect the treatment mentioned

4） Patients participating in other clinical trials

5） Patients with a medical history of other malignant tumors

6) Pregnant and breast-feeding women
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation

This study will compare the bioavailabity of three new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, postmenopausal women ages 35 to 70 years, inclusive.
* Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation. Naturally postmenopausal women must not have had a menstrual period since the age of 54. Surgically menopausal women must have undergone bilateral oophorectomy (removal of both ovaries) at least 6 months prior to the start of the study, and the surgical report may be requested to confirm the surgery date and that the surgery was not due to a cancerous condition.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
The Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Impairments in PD

This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients . We hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve gait impairments and cortical activity in Parkinson's disease patients.

Patients in the Experimental group underwent seven consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent seven consecutive daily sessions of sham taVNS. Assessments of gait function, motor symptoms and cortical activity (using Functional near-infrared spectroscopy) were performed two times: at baseline, one day post intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
2. Hoehn and Yahr stage ≤ 2 during ON medication state.
3. Age between 40 and 80 years old.
4. Mini-Mental State Examination score \>24.
5. Ability to walk at least 60s independently.
6. Stable medication

Exclusion Criteria:

1. Patients with significant visual impairment or coexisting local or systemic diseases (e.g. osteoarthritis or other neurological conditions) likely to affect gait were excluded from our study.
2. Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker were also excluded
3. Patients with known or suspected cardiovas-cular disease, uncontrolled hypertension or recent myocardial infarction were also excluded from the study.
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin

Drug-drug interaction study between Bemnifosbuvir/Ruzasvir and Digoxin or Rosuvastatin


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
* Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.
* Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
* Abuse of alcohol or drugs.
* Use of other investigational drugs within 28 days of dosing.
* Concomitant use of prescription medications, or systemic over-the-counter medications.
* Other clinically significant medical conditions or laboratory abnormalities.
Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation

The purpose of this study is to investigate whether a social initiation motivation intervention (SIMI) focused on training children with ASD to initiate to peers during structured play activities will result in more frequent initiations to typically developing peers during free play. The SIMI approach under investigation uses behavioral strategies based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with ASD to initiate to peers. Children with ASD will be randomly assigned to either the SIMI or a waiting list. Treatment will be provided for 8 weeks in the context of a weekly social skills group.


Eligibility Criteria:
Inclusion Criteria:

1. age 4.0 to 6.11 years;
2. diagnosis of Autism Spectrum Disorder
3. without intellectual disability
4. stable community treatments four weeks before and throughout the trial.

Exclusion criteria:

1. diagnosed severe psychiatric or genetic disorder or medical problem;
2. severe disruptive behavior that would interfere with peer interactions
Model Based Fast Anatomical Mapping

This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.

This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.

Specifically, the study will assess the following issues in atrial fibrillation ablation:

1. Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)
2. Left atrial geometry creation time
3. Fluoroscopy time

The clinical team will hypothesize that this approach will lead to accurate LA geometry creation more rapidly and using less fluoroscopy than standard techniques

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Have AF as follows:

  1. Paroxysmal AF - defined as AF that is non-sustained (terminate without electrical or pharmacologic cardioversion) lasting \< 7 days.
  2. Persistent AF - defined as AF that is sustained \> 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.
* Are planned to undergo a first catheter ablation procedure (prior typical atrial flutter is allowed)
* Have the ability to understand the requirements of the study and sign the informed consent form.
* Are willing to adhere to study restrictions and comply with all post-procedural follow-up requirements

Exclusion Criteria:

* Rheumatic heart disease,
* Current intra-cardiac thrombus
* Class IV HF
* Unable to sign consent
* Unstable angina
* Recent cerebral ischemic events
* Contradiction to anticoagulation
* Prior cardiac surgery
* Complex congenital heart disease
The Performance of Multi-tracer Multimodality PET in Lymphoma

Investigating the performance of Multi-tracer Multimodality PET in lymphoma

In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by different molecular probe such as FDG, FAPI-04 via multimodality PET (PET/CT and PET/MR). Our Previous studies have shown that uptake of FAPI-04 on PET may be an indicator of lymphoma lesions. The combination of PET with CT/MR allows for depicting metabolic, functional and morphological properties of tumor lesions at the same time, which is therefore an alternative attractive pairing for diagnosis, staging and prognosis of lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed as lymphoma;
* Written informed consent for receiving FAPI-04 PET examinations.
* cancer planned chemotherapy or immunotherapy scheme.
* expected survival ≥ 12 weeks

Exclusion Criteria:

* cannot lie supine for half an hour;
* refuse to join the clinical researcher;
* severe liver or kidney dysfunction
* pregnancy or lactation
Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)

Symptoms of Primary Immune Thrombocytopenic Purpura (pITP), such as spontaneous bruising, menorrhagia, mucosal bleeding and other symptoms might significantly affect the HRQOL of pITP patients. However, very little evidence exists on HRQOL outcomes in patients diagnosed with pITP. The investigators project will aim at providing scientific community solid evidence based data on the extent to which HRQOL is compromised and in which specific area.

The purpose of this study is thus to compare generic Health-related Quality of Life (HRQOL) profiles of adult patients with primary Immune Thrombocytopenic Purpura (pITP) with that of a matched Italian population control Group.

OBJECTIVES:

The primary objective is to compare HRQOL of patients with pITP with that of a matched Italian population control Group.

Secondary objectives include evaluation of:

* Patient-reported fatigue amongst the three different pITP groups.
* Social support and psychological wellbeing as a possible determinant of HRQOL.
* Possible association between socio-demographic (e.g., age, living arrangements, education and employment status) and clinical variables (e.g., time from diagnosis, and current treatment if any) with patient reported health outcomes (e.g., HRQOL, fatigue, and social support).
* To assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics and to compare patient's stated preferences for involvement in treatment decision with the perceptions of their treating physicians (only for Newly Diagnosed pITP).

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of pITP in any phase of the disease;
* Patients aged at least 18 years;
* Informed consent provided

Exclusion Criteria:

* Participating in other HRQOL investigations that might interfere with this study
* Having any psychiatric condition or major cognitive impairment hampering self-reported HRQOL evaluation.
The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes

To determine whether the management of type 2 diabetes mellitus (DM2) can be transferred from an internist to a supervised nurse specialized in diabetes (NSD) with a comparable quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.

Diabetes mellitus type 2 (DM2) is a chronic, progressive illness which causes considerable morbidity and premature mortality.1-2 The worldwide prevalence of DM2 is high and is increasing steadily, also in The Netherlands.3-4 The burden of DM2 on health care has also increased because of the intensified cardiovascular risk management being practiced to prevent macrovascular morbidity and mortality in these patients.5 In the treatment of DM2, tight guidelines are increasingly recommended for optimizing glycaemia, blood pressure and lipid profile.6 Therefore, the burden of treatment has increased and will further increase per patient as well as per population with DM2. In order to meet this problem, we tested, in the current study, the hypothesis that well defined routine aspects in diabetes care, previously handled only by medical doctors in secondary care setting, may be safely transferred to supervised nurses specialized in diabetes (NSD), including the prescription of medication, resulting in at least the same quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* patients with DM2 who were referred by GPs to the diabetes outpatient clinics

Exclusion Criteria:

* macroalbuminuria
* serum creatinine level \> 135 mol/l,
* Cockcroft \< 50 ml/min
* alanine aminotransferase (ALT) \> 120 U/l
* pregnant woman