cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Rentability of Screening for Associated Conditions in Calcium Pyrophosphate Deposition Disease Patients

The purpose of this study is to determine whether thorough analytical evaluation is useful to diagnose metabolic conditions associated to calcium pyrophosphate deposition disease.

The diagnostic usefulness of screening for hyperparathyroidism, hemochromatosis, hypothyroidism and hypophosphatasia in patients diagnosed with calcium pyrophosphate dihydrate (CPPD) deposition disease is uncertain.

Patients diagnosed with CPPD deposition disease were compared to patients with rheumatoid arthritis and psoriatic arthritis over a 9-year period. All patients were prospectively followed for at least 12 months. Serum calcium, phosphorus, alkaline phosphatase, thyroid-stimulating hormone, ferritin, iron, and total iron binding capacity were determined in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as having calcium pyrophosphate dihydrate deposition disease.

Exclusion Criteria:

* Patients mimicking a rheumatoid arthritis disease, with positive rheumatoid factor or with psoriasis.
Potassium and Sodium to Control Blood Pressure in Hypertensives

To examine the role of dietary sodium reduction with and without potassium supplementation in controlling blood pressure in hypertensive men.

BACKGROUND:

Appropriately increased interest and concern about high blood pressure as a major public health problem coincided with the indication that the risks of hypertension-related morbidity and mortality could be reduced by reduction of blood pressure. Consensus suggestions that individualized approaches be used in treating patients with mild hypertension stimulated further investigations of non-pharmacological methods. Such investigations were also of considerable interest in relation to understanding the physiology of blood pressure control as well as the development of less costly non-drug therapies. Interest was heightened by information suggesting that there might be distinctly harmful side effects related to antihypertensive drug therapy, particularly thiazide diuretics, in some settings. Studies of non-drug therapies included dietary modifications primarily involving weight reduction and sodium restriction with increasing recent concern about other factors such as alcohol intake, dietary fat, calcium, magnesium, and potassium intake.

DESIGN NARRATIVE:

Randomized, double-blind. One hundred forty-five subjects were randomized into a low sodium placebo group in which sodium intake was restricted to no more than 80 mEq/day, 142 subjects into a potassium supplementation (96 mEq/day) group whose sodium intake was also restricted to no more than 80 mEq/day. After 12 weeks of intervention, antihypertensive drugs were withdrawn. Follow-up of each participant was for at least two years. The primary endpoint was the proportion of subjects requiring antihypertensive medication at various points following randomization.

Eligibility Criteria:
Men, ages 45 to 68. Subjects were hypertensive, were treated for at least 3.5 years with antihypertensive drugs and whose diastolic blood pressure was less than 90 mm Hg.
BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

To compare the outcome of Anterior Cruciate Ligament (ACL) reconstruction performed using the tibialis allograft to historical outcomes of ACL reconstruction patients and to establish if any correlation exists between the age of the graft donor and the clinical outcomes.

This is a single-arm, single site, pilot study in patients with a ruptured ACL. A total of fifty (50) subjects will be enrolled in this trial. All patients will have been scheduled to undergo ACL reconstruction and will receive a BioCleanse Tibialis allograft as part of the normal standard of care practiced by the treating surgeon. Follow up is for 2 years.

However, there is no assignment of graft, specific to donor age, to the patients. All treatment will follow standard of care and this study assumes that there will be a normal distribution of graft donor ages, from 18 to 65 years of age.

Patient outcomes will be compared between the 2 groups of tendon donor ages. Neither the surgeon nor the patient will be aware of the age of the graft donor, per typical standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Study subjects will be limited to those subjects undergoing allograft anterior cruciate ligament reconstruction surgery
2. Meniscal injuries may be included
3. Isolated, unilateral anterior cruciate ligament injury.
4. All subjects will have a minimum age of eighteen (18) years and a maximum of sixty (60) years.
5. Both male and non-pregnant female subjects will be included.
6. To facilitate follow-up, study subjects will be limited to the local geographic area of the study site and be willing to use the rehabilitation facility and physical therapy schedule assigned by the surgeon.
7. All subjects must be able to read, write, and comprehend instructions and guidelines in English and understand (and sign as an acknowledgment of their understanding) an informed consent declaration.

Exclusion Criteria:

1. No chondral defects
2. Failure to comply with or meet all of the inclusion criteria listed above.
3. Autograft anterior cruciate ligament surgery on either knee.
4. Anterior cruciate ligament injury on contra-lateral leg at any time
5. Multi-ligament reconstruction
6. Inability to comply with all requirements of this investigation, as well as follow the instructions of the physician.
7. Significant systemic disease or conditions which impact overall health or well being or which necessitate chronic medication use.
8. Revision anterior cruciate ligament surgery to either knee at anytime
9. Exhibiting signs of moderate to severe degenerative joint disease in addition to requiring anterior cruciate ligament surgery.
10. Concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion.
Immediate Effects of High-intensity Laser Therapy on Knee Joint Position Sense and Knee Muscle Strength in Patients with Knee Osteoarthritis

The goal of this clinical trial is to compare whether HILT versus Sham-HILT is effective to reduce pain, improve knee joint position sense, and knee muscle strength.

Participants will undergo a single-session of HILT or Sham-HILT, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.

The investigators would like to investigate whether single session of high-intensity laser therapy (HILT) is promising to see the changes in individuals with knee osteoarthritis (KOA)-related knee pain regarding pain intensity, knee joint position sense, and knee muscle strength.

The objectives of this study is to compare pre and post, and between the two groups (HILT versus Sham-HILT) at after interventions regarding pain, knee joint position sense, and knee muscle strength.

Participants will undergo a single-session of HILT or Sham-HILT by an experienced musculoskeletal physical therapist, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.

Eligibility Criteria:
Inclusion Criteria:

* knee pain greater than 3 on the Visual Analog Scale (VAS) for more than 3 months
* diagnosed with unilateral knee osteoarthritis by a physician or meeting the American College of Rheumatology Classification Criteria for clinical knee osteoarthritis
* the severity of knee osteoarthritis is classified as grades 0-3 according to the Kellgren-Lawrence (KL) classification
* should not have undergone any specific treatments in the 3 months preceding the recruitment for the study, such as steroid injections.

Exclusion Criteria:

* any other musculoskeletal problems associated with knee pain
* musculoskeletal problems associated with the hip and ankle joints
* a history of lower limb fracture
* neurological conditions
* contraindications for laser therapy
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia

Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.

Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a schizophrenic disorder (F20 according to ICD-10),duration of disease ≥ 12 months
* Appliance of the t-VNS® medical device according to the manual

Exclusion Criteria:

* Improvent of the PANSS score within the period of 2 - 4 weeks from screening to the baseline
* Pregnancy
* Bronchial asthhma in medical history
* clinically relevant internistic, neurological or psychiatric diseases
* abuse of drugs or alcohol until 4 weeks to enrollment
* Traumatic brain injury in medical history as well as invasive and non-invasive methods of treatment (e.g. tumor surgery (Gammma knife surgery))
* indication of structural impairment of the basal ganglia or the brain stem
* malformations of the pinna
* further circumstances that at the discretion of the investigator will not allow to include the subject into the clinical study
To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study

This study is a confirmation study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders. The purpose of this study is to validate the 4ch NMES device.

* Design: Prospective study
* Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
* Intervention: applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"
* Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory

Eligibility Criteria:
Inclusion Criteria:

* patient who do not belong to the criteria excluded for subjects aged 19 years or older
* Patient who is confirmed to be dysphagia by videofluoroscopy
* Patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury
* Those voluntarily agreeing to the clinical trial

Exclusion Criteria:

* Patient who refuse inspection, do not agree
* Simple "Commend obey", first step is impossible
* When instructions can not be executed due to dementia, psychiatric disorders, etc.
* Dysphagia occurs due to respiratory failure, neck surgery, etc.,
* Pregnant women and lactating women
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy and safety in patients with postoperative supraventricular tachyarrhythmias.


Eligibility Criteria:
Inclusion Criteria:

1. 20-80 years old
2. Postoperative supraventricular tachyarrhythmias (sinus tachycardia, those with a heart rate of 120 beats/min or higher, and supraventricular arrhythmia, those with a heart rate of 100 beats/min or higher)
3. Within 7 days postoperatively
4. Other inclusion criteria as specified in the protocol

Exclusion Criteria:

1. Acute myocardial infarction (within 1 month after onset)
2. Severe heart failure (New York Heart Association functional class III or higher)
3. Atrioventricular block (grade II or higher),or sick sinus syndrome
4. Other exclusion criteria as specified in the protocol
Effects of Combined Cognitive Training With Aerobic Exercise in Stroke Patients With MCI

Cognitive impairments have severe impact on functional recovery and quality of life after stroke. Current evidence indicated that combining exercise and cognitive training may provide additional benefits on cognition in stroke. This study aims to investigate the effects and mechanisms of two combined methods of computer-based cognitive training with physical exercise in stroke patients with cognitive impairments.

Cognitive impairment is not uncommon after stroke. Stroke patients with cognitive decline may experience difficulties in learning motor tasks, functional disability, and poor quality of life. Interventions for cognitive impairment remain under development and pharmaceutical intervention is not yet optimal at present. Targeted cognitive treatments or aerobic exercise training provided potential benefits to enhance cognitive function for stroke patients with cognitive decline. Recent studies demonstrate that combining exercise and cognitive training may provide additional benefits on cognition than single type of training. However, physical exercise training and cognitive-based intervention can be combined either sequentially or simultaneously. It remains unclear whether the two combination methods induce similar or differential effects in brain plasticity, physiological modulation, and behavioral outcomes for individuals with stroke. It is important to examine the potential effects, comparative effects and the neural mechanism of two combined interventions that can possibly maximize benefits for stroke survivors with cognitive impairments.

The purposes of the present study are to: (1) examine and compare the effects of two combined interventions on brain plasticity, physiological biomarkers and behavioral outcomes, including cognitive, physical, and daily functions, and quality of life, from pre- to post-training; (2) understand the neural mechanisms of cognitive recovery following two combined interventions using the electroencephalography (EEG); (3) examine the long-term benefits following the two combined interventions; (4) to identify the correlations between brain activity, biomarkers and behavioral measures.

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
2. Age range from 20 to 90 years
3. MMSE score \< 28, or MoCA score \< 25
4. Self- or informant-reported memory or cognitive complaints or Clinical dementia rating (CDR) scale ≤ 0.5
5. Able to follow the study instruction
6. Adequate cardiopulmonary function to perform aerobic exercise
7. Able to walk with or without assistive devices

Exclusion Criteria:

1. Unstable medical history (e.g., recent myocardial infarction) that might limit participation
2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
3. Current participation in another interventional trial
Multimodal Imaging of Hypoxia in Gliomas

The imaging of cerebral oxygenation is an extremely important tool in understanding the pathophysiology of the tumor and for adaptation of therapies according to hypoxia. Currently, imaging of cerebral oxygenation is mainly performed by the use of Positron Emission Tomography (PET). Thus, the investigators have been able to show that the FMISO radiotracer can reveal tumor hypoxia (HypOnco study, promotor: Caen University Hospital, main investigator: J.S. Guillamo). After injection of the radiotracer, increased uptake is observed in the regions for which the tissue oxygen pressure is less than 10 mmHg (the healthy brain with a tissue oxygen pressure (ptO2) ≈ 40mmHg).

Although PET is a reference methodology, it is not widely practiced mainly because of radioactive sources. Magnetic Resonance Imaging (MRI) would bypass the previously mentioned PET limitations. The investigators have recently shown that a measure of local oxygen saturation could be obtained by MRI.

This methodology has also been implemented at a clinical scale on lower field MRI magnets, but its formal validation in a clinical situation remains to be demonstrated with respect to FMISO.

The major advantage of this methodology is that MRI is already performed in routine practice for patients. Measuring tissue oxygenation with MRI (SatO2-MRI) would not add additional examination for the patient. In addition, MRI is a non-ionizing methodology with a very good spatial resolution compared to PET, this should help to better understand intratumoral heterogeneity. Similarly, in preclinical studies, the investigators have shown in a context of mild hypoxia that SatO2-MRI may be more sensitive than PET.

The investigators propose a study to compare in patients with glial tumors, images obtained by 3 Tesla MRI of SatO2-MRI to the hypoxia maps obtained by FMISO PET. These imaging studies will be confronted with studies carried out in immunohistochemistry on biopsies / resection allowing to reveal and to quantify by image analysis the expression of the factors induced by hypoxia (HIF1, HIF2).

This study should include 20 patients with glioma (15 high-grade patients and 5 low-grade patients) in pre-surgery. The aim is to show that SatO2-MRI is a relevant methodology (in terms of sensitivity, specificity) for assessing intratumoral oxygenation in a context of brain tumors. This fits perfectly into an era of personalized medicine where functional imaging finds its meaning.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years-old)
* Patient with a diffuse glioma (astrocytoma or oligodendroglioma or glioblastoma)
* Karnofsky index ≥ 70%
* Patient able to understand and sign the consent or accompanied by a trusted person who can do so
* Normal blood test with results: neutrophil ≥ 1500 cells / μl, platelets ≥ 100,000 μl, serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5 x upper normal limit (UNL), creatine ≤ 1.5 x UNL
* Patient affiliated to a social security

Exclusion Criteria:

- Patient with contraindications to surgery
Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab

The goal of the study is to find out the effects of two different drugs used at the beginning of organ transplantation on different populations of immune cells in the body of patients.


Eligibility Criteria:
Inclusion Criteria:

* all patients considered for transplantation

Exclusion Criteria:

* none
Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study

The radiotherapy scheme with extreme hypofractionation has gained space in clinical practice and, therefore, it is necessary to analyze the Brazilian national experience in selected patients with breast cancer, with the aim of evaluating the oncological outcomes and toxicities with the use of this treatment protocol.

All patients diagnosed with breast cancer who meet the eligibility criteria at participating centers will be included. Data will be collected from medical records at selected centers. Data collection will start from the location activation date. Data from up to 500 patients are expected to be collected at centers across Brazil.

Patients recruited for this study will be identified at participating centers. Data on clinical, demographic and socioeconomic variables will be collected, as well as data on treatments performed and outcomes.

The patient data sources will be the patients' medical records. Patients will continue to receive treatment and clinical evaluations for their illness as determined by their medical team, in accordance with the standards of care and usual clinical practice at each center. No intervention is proposed in this study.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years old;
* Diagnosis of breast cancer of any molecular subtype;
* Undergoing extreme hypofractionated radiotherapy (5 x 5.2Gy) postoperatively;
* Treated from December/2019 onward;
* With clinical and treatment data available in medical records.

Exclusion Criteria:

* The protocol does not provide exclusion criteria.
Burden of Disease in Hypophosphatasia (HPP)

Hypophosphatasia (HPP) is a rare, inherited metabolic disease caused by inactivating mutations in the Alkaline Phosphatase (ALPL) gene, coding for the Tissue-nonspecific alkaline phosphatase (TNAP). Penetrance and disease severity is very heterogenous, ranging from stillbirth to adult-onset manifestations. Especially the latter are again characterized by an extremely broad spectrum of symptoms. This scope of variability makes it difficult to attribute individual patients' symptoms to the disease and distinguish them from HPP independent health issues. Especially in adult HPP patients, musculoskeletal problems, including (fragility-) fractures / bone bruise, joint pain, reduced mobility, muscular weakness and pain and reduced muscular endurance appear to reflect the prevailing burden of disease, especially with respect these patients dis-abilities of daily life.

To expand current knowledge of the natural history of the disease as well as on disease specific musculoskeletal deficits in HPP, all adult patients with established Diagnosis of HPP known at the Orthopedic Institute, University of Würzburg, will be offered to participate in a single, multimodal assessment of their disease history, current symptoms and disabilities, lab evaluations and clinical and technical analysis of their musculoskeletal status and capabilities.

Patients will be invited to a day long visit to the clinic in order to perform the following assessments:

A) Epidemiologic / anamnestic information B) Physical examination C) Structured questionnaires D) Laboratory examinations E) Clinical functional testing F) Technical Examinations


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females (age ≥ 18 years)
* Established diagnosis of Hypophosphatasia
* Reduced Serum/Plasma ALP (Alkaline phosphatase)-Activity below age and sex specific reference range of the respective test kit applied (measured at least twice with a minimum 4 week interval)
* At least one of the items below:

  * Genetically secured ALPL-Mutation
  * Elevated PLP (Pyridoxal 5-Phosphate) (urine or serum), above ULN (Upper level of normal)
  * Symptoms of the disease
* Signed informed consent

Exclusion Criteria:

* Current / previous treatment with Asfotase alfa
* Current participation in another clinical study
Chloroquine for Glioblastoma.

Adjuvant chloroquine to the conventional treatment for glioblastoma; A randomized, single-blind, placebo-controlled, phase I/II trial.


Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed glioblastoma Adequate hematologic, hepatic, and renal function Karnofsky performance status score ≥ 70% Life expectancy ≥ six weeks

Exclusion Criteria:

Abnormal severe un-controlled medical conditions