cyrilzakka/clinical-trials huggingface dataset:
Real-world Evidence of COVID-19 Vaccines Effectiveness

This is an observational case-control study to evaluate COVID-19 vaccine effectiveness against hospitalisation with COVID-19 related conditions in St. Petersburg, Russia. Two sets of cases and control will be retrospectively analyzed to compare vaccination proportions and other characteristics to infer vaccine effectiveness from odds ratios. The first set of cases will be extracted from the data on hospitalisation of patients with COVID-19 to First Pavlov State Medical University of Saint-Petersburg hospitals, and controls will be patients hospitalised with other conditions. The second set of cases and controls will be based on patients referred to Medical Institute named after Berezin Sergey for computed tomography. Cases will be patients with positive SARS-CoV-2 status computed tomography confirmed pneumonia or patients referred to hospitalisation, and control will be patients without pneumonia and not referred to hospitalisation.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized to clinics of First Pavlov State Medical University of Saint-Petersburg
* Patients referred to Medical Institute named after Berezin Sergey for computed tomography
* Available vaccination status

Exclusion Criteria:

- Refusal to provide information for research purposes at the time of hospitalization or reference to computed tomography
CA-125 and Severity of Pre-Eclampsia

The Aim of this study is to determine the relationship between serum concentrations of cancer antigen-125 (CA-125) and pre-eclampsia severity.

Although the source of CA-125 during pregnancy is the fetal chorion, amniotic fluid, and maternal decidua, the perinatal dynamics of maternal serum CA-125 requires clarification. Clinical studies of CA-125 levels and its function in hypertensive pregnant patients are limited and offered contradictory results (Cebesoy et al., 2009).

And so we investigate CA-125 in normal pregnancy and in pre-eclampsia, comparing mild and sever pre-eclampsia to determine relationship of CA-125 and severity of the disease.

Patients will be divided in three groups:

* Control: 40 normal healthy pregnant women attending the ER in labor.
* Mild pre-eclampsia: 40 patients fulfilling the following criteria.

  * Blood pressure: systolic blood pressure \>140 and \<160 , Diastolic blood pressure \>90 and \<110
  * Proteinuria: 300 mg (+) assessed by urine urignost 3A® (urine strips from DIALAB).
  * No symptoms of severity as headache.
  * Normal investigations for different organ function (as liver and kidney function).
* Severe pre-eclampsia :40 patients fulfilling anyone or more of the following criteria (The American College of Obstetricians and Gynecologists, 2010)(ACOG):

  * Systolic blood pressure \> 160 mmHg
  * Diastolic blood pressure \> 110 mmHg (on two occasions at least 6 hours apart while the patient is on bed rest)
  * Proteinuria of 5000mg (5g) or higher on a 24-hour urine collection or at least 3+ on two random urine samples collected at least 4 hours apart
  * Oliguria \< 500 mL urine output in 24 hours
  * Cerebral or visual functional disturbances (cns irritability)
  * Pulmonary edema or cyanosis (not due to excessive intravenous volume replacement)
  * Epigastric or right-upper quadrant abdominal pain
  * Impaired liver function on laboratory analysis (elevated aspartate aminotransferase (AST), alanine amino transferase(ALT), or lactate dehydrogenase(LDH))
  * Thrombocytopenia (platelet count \< 150,000/uL)
  * Fetal growth restriction.

Eligibility Criteria:
Inclusion criteria:

* pregnant women 3rd trimester
* any age
* medically free at least by history
* signs and or symptoms of pre-eclampsia

Exclusion Criteria:

* Other causes elevate CA-125 as: ovarian cancer, endometrial cancer, breast cancer and benign conditions as: endometriosis and liver cirrhosis.

Chronic hypertension

* Diabetes Mellitus (DM)
* Liver diseases
* Thyroid disorders
* Kidney diseases
* Cardiac diseases
Low Intensity Pulsed Ultrasound Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis

To compare the effects of low intensity pulsed ultrasound with high intensity continuous ultrasound in knee osteoarthritis

Knee osteoarthritis is a common disorder affecting elderly and obese. Currently, there are 3 types of treatment; pharmacological, non-pharmacological and surgery. Though ultrasound, a non-pharmacological treatment, is increasingly used in knee osteoarthritis, the advantages and disadvantages of low intensity pulsed ultrasound (LIPUS) and high intensity continuous ultrasound (HICUS) are yet to be clarified. Therefore, a randomized control trial will be done to compare LIPUS and HICUS in participants with knee osteoarthritis presenting to Department of Physical Medicine and Rehabilitation, Yangon General Hospital, Myanmar.

Eligibility Criteria:
Inclusion Criteria:

* Participants with knee pain (VAS 3 to 6)
* Kellgren and Lawrence grade 2 and 3 in X' ray knee joint

Exclusion Criteria:

* Rheumatoid arthritis, Gouty arthritis, Spondyloarthropathies, Metabolic arthropathies
* Infection of knee joint
* Tumor of knee joint
* History of hypersensitivity to heat
* Previous knee surgery in affected side
* Intra-articular injection within previous 3 months
* Participants taking treatment with other physical modalities such as low-level laser therapy and Trans Cutaneous Electrical Nerve Stimulation
Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes

Participants who were previously Viome costumers who signed informed consent to participate and self reported type 2 diabetes or pre-diabetes were enrolled. They provided stool samples to VIOME and were provided with precision diet and supplement recommendations. The information obtained from this study is used to train a model to predict diabetes and/or risks of developing diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Viome customer
* GI test collected at home using Viome test kit
* US citizen
* 18+ years old
* Is not participating in any other Viome study
* Must have answered the following on-boarding question with the indicated answer:

"Do you or did you ever have diabetes or prediabetes?"

* Signed and dated informed consent prior to any trial-specific procedures are performed
* Able to speak and read English
* Willing and able to follow the trial instructions

Exclusion Criteria:

* Unable/unwilling to complete the informed consent form and the questionnaires
The Comparison of Quality of Life in Patients With Pancreatogenic Diabetes After Pancreatectomy

Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the reason why this form of surgery technique is seldom performed. However, with the progress of medical and surgical care nowadays, patients undergone TP could receive better care in endocrine and exocrine insufficiency. In addition, with better understanding of benign pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the quality of life of patients with pancreatogenic diabetes after TP is still currently controversial.

Purpose: The purpose of this study is to (1) explore the association of fatigue, self-care activities and quality of life in patients with pancreatogenic diabetes after total pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.

Method: A correlational and comparative cross-sectional approach will be used. The data will be collected with a structured questionnaire via purposive sampling of 120 subjects in an outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent. Exclusion criteria will be the patients diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go through propensity score matching and will be analyzed by using descriptive statistics, paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.

Anticipated achievement: The anticipated achievement of this study is to understand the relationships between fatigue, self-care activities, and quality of life in patients with pancreatogenic diabetes after pancreas surgery. In addition, through this study, the influence of diabetes to patients after pancreatic tumor resection can be explored; and the factors that influence the population's quality of life can be examined. By the filling of this knowledge gap, intervention can be planned accordingly to help improve the population's quality of life.


Eligibility Criteria:
Inclusion Criteria:

* (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent

Exclusion Criteria:

* diagnosed with cancer other than pancreatic cancer and under active treatment
Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression (rTMS)

The hypothesis of this study was that transcranial magnetic stimulation (TMS) focused on hyperfunctional cerebral areas should be more effective in treating depressive symptoms than stimulations not taking into account the functional specificity of the patient. The goal was to compare the effects of "guided" TMS, using neuroimaging to guide TMS on dysfunctional cortical regions individually detected by neuroimaging, with "standard TMS", as used in most studies, over the left prefrontal cortex, and with sham TMS, in patients with resistant depression.

The objectives of the study were :

* To localize the site of lowest frontal activity in each patient with resistant depression, using PET to measure regional cerebral metabolic rates for glucose (rCMRGlu).
* To demonstrate that high-frequency TMS (10Hz) guided on that site is more effective than standard or sham TMS, in resistant depressed patients, using a doubled blind controlled procedure.
* To assess the effects of TMS on regional cerebral metabolism using rCMRGlu PET after 10 sessions of TMS treatments.

Depressed patients meeting DSM-IV criteria for Major Depressive Disorder, aged between 18 and 55, have been included. They met criteria for depression resistant to antidepressant drugs They were randomised in 3 groups: guided prefrontal TMS, standard left prefrontal and sham left prefrontal TMS.

rTMS was administered daily on working days, for two weeks. Ten stimuli per second (10Hz) were applied in 20 courses so that patients received 1600 stimuli per day. Guided TMS was on a prefrontal target corresponding to the highest statistically significant hyperfunctional cluster determined with rCMRGlu PET. Standard stimulation was left pre-frontal, 5 cm anterior to the optimal stimulation point of the abductor pollices brevis. Stimulation strength was chosen at 90% relative to motor threshold. Sham rTMS used a procedure identical to the real standard treatment, but using a sham coil.

Eligibility Criteria:
Inclusion Criteria:

* Major depression (according to DSM-IV)resistant to at least two medical antidepressant treatment of different pharmacological action, prescribed for at least one month each at an effective dosage, without therapeutical result.
* Hospitalisation in the service of an investigator
* Informed consent signed

Exclusion Criteria:

* Presence of metallic parts inside the body (pace-maker, vascular clip, cardiac valve, prothesis...)
* Severe somatic or central nervous system disease
* Familial history of comitiality
* Pregnancy
Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces

This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides, the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this, 100 babies 1-3 years will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis will be conducted using the International Caries Detection and Assessment System (ICDAS). Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6, 12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered. Acceptability reported by parents after treatments, the time and estimated money spent for treating will also be collected. Social and biological data that could be related to efficacy of techniques will be also collected. Multilevel analyses will be performed to check which technique will be most effective and possible factors associated to its efficacy. Discomfort, acceptability and costs will be compared between/among the approaches used to arrest enamel caries lesions.


Eligibility Criteria:
Inclusion Criteria:

* Babies 1 to 3 years;
* Babies with initial dental caries lesion.

Exclusion Criteria:

* Parents who do not consent.
Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain

The study evaluates the combined effect of optimized pharmacological treatment, spinal cord stimulation and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. All patients will receive optimized pharmacological treatment before start of spinal cord stimulation treatment. Half of the participants will be randomized to physiotherapy before start of spinal cord stimulation treatment while the other half will start physiotherapy after spinal cord stimulation treatment.

Previous studies have indicated that almost half of the patients with moderate-severe pain receive inadequate pain relief. Neuropathic pain is a common pain condition, affecting 1.5-8% of the population. Conventional pharmacological treatment reduces pain but is often insufficient. Spinal cord stimulation (SCS) is associated with improved pain relief and health-related quality of life compared to conventional medical management. Despite SCS treatment, only half of the patients report \>50% pain relief. Other studies have indicated that active, specific physiotherapy led by professionals reduces pain in chronic pain conditions. The aim of the study is to access the combined effect of optimized pharmacological treatment, SCS and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. Furthermore, the study evaluates when it is most effective to start the physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Neuropathic pain \> 6 months
* Pain intensity ≥ 5 according to NRS (for neuropathic pain component to be treated with SCS)
* Known cause of the pain
* Neuroanatomical correlation to the pain
* ≥50% of the painful area is to be treated with SCS
* The patient has a physical and psychological health status that allows the patient to participate in physiotherapy and undergo SCS implantation.

Exclusion Criteria:

* Not able to undergo SCS implantation
* Inadequate knowledge of the Swedish language
* Alcohol or substance abuse
* Severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition
* Incapacitating pain conditions of other causes than neuropathic pain
* Pregnancy
* Insufficient compliance
* Malignant disease with short expected survival
Long-Term Exercise Training Therapy Versus Usual Care in Patients With Schizophrenia

Patients with schizophrenia have disabling symptoms and cognitive deficits that limit motivation, drive, social- and occupational performance, quality of life and self-efficacy. Schizophrenia also leads to a high risk of dying from cardiovascular disease. Explanatory trials suggest that exercise improves cognitive functioning, symptoms, and quality of life, and reduces the risk of cardiovascular disease. However, due to this illness, the participation in regular exercise is challenging. In this study it will be tested if patients with schizophrenia can participate in long-term exercise therapy, and whether long-term supervised exercise therapy is more beneficial than today's usual care.


Eligibility Criteria:
Inclusion Criteria:

* International Classification of Diseases (ICD-10) schizophrenia, schizotypal or delusional disorders (F20 to F29)
* able to carry out long-term exercise.
* capable of giving informed consent.

Exclusion Criteria:

* contra-indication for exercise training and testing according to the American College of Sports Medicine (ACSM) specifications (life threatening or terminal medical conditions; not able to carry out intervention or test procedures; current pregnancy; mothers less than 6 months post-partum).
* patients under admittance to an acute psychiatric ward.
Dried Blood SPOT Analysis of Everolimus in Cancer Patients (SPOT-study)

Everolimus shows a large interpatient variability with fixed dose administration. These very different exposure levels between individuals can result in supratherapeutic or subtherapeutic exposure levels and consequently in over- or undertreatment, respectively. Dose individualization based on the measured drug concentration could theoretically result in less toxicity and more efficacy.

Nowadays everolimus exposure is determined by everolimus concentration in whole blood. Therefore, a vena puncture is always necessary. This is invasive and requires patients to come to the hospital. It would be convenient for patients to have their everolimus blood concentration determined by dried blood spot (DBS) analysis. With DBS only a single drop of blood from the finger is necessary, which can be done at home and sent by regular mail for analysis. Previous studies have shown the feasibility of this approach. In patients with cancer treated with everolimus 10mg once daily, the correlation between everolimus DBS concentrations and whole blood concentration is yet unknown. Therefore, the investigators want to determine the everolimus concentration collected with DBS from a finger prick with everolimus concentration from whole blood and everolimus concentration collected with DBS from whole blood.

In addition, possibly a relatively high everolimus concentration in saliva could be correlated with the incidence and severity of oral mucositis. Determination of drug concentration in saliva has also been proven to be feasible before.

Therefore, in this study the investigators want to determine whether the everolimus concentration in saliva correlates with the incidence of oral mucositis and how everolimus concentration in saliva correlates with everolimus concentration in whole blood.


Eligibility Criteria:
Inclusion Criteria:

* Patients currently treated with everolimus for any type of cancer
* Patients from whom it is possible to collect blood samples
* At least 18 years of age
* Able and willing to sign the Informed Consent Form prior to study assessments.

Exclusion Criteria:

* None
Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 3 (HEAR3D_CE3)

A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strengths and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at the University Hospital of Zürich.


Eligibility Criteria:
Participants fulfilling any of the following inclusion criteria are eligible for the study:

* Adult persons (minimum age: 18 years)
* Healthy outer ear (without previous surgical procedures, except cochlear implantation)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Normal hearing participants

• Adult persons with audiometric normal hearing thresholds

Hearing impaired participants

* Adult hearing impaired persons with and without (experience with) hearing aids
* Adult hearing impaired persons with cochlear implant(s)

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders