cyrilzakka/clinical-trials huggingface dataset:
Pilot Study: Use of the Saccadometer to Detect Characteristic Saccadic Peak Velocity in Myasthenia Gravis Patients

Fast eye movements have been shown to demonstrate characteristics that are specific to myasthenia gravis that are not present in other eye movement disorders. It is possible to measure these eye movements and potentially identify these characteristics using new portable eye movement testing equipment. The aim of this pilot study is to discover if these characteristics can be identified using portable eye movement testing equipment in patients with a confirmed diagnosis of myasthenia gravis.

The diagnosis of Myasthenia Gravis (MG) can be challenging, particularly in its ocular manifestation with current clinical procedures. Previous research has shown that fast eye movements in patients suffering with MG have quite specific characteristics that can be used to correctly diagnose the condition. The Saccadometer is a portable eye movement testing device that may provide the ability to detect the characteristics of fast eye movements that Myasthenia patients alone demonstrate - specifically these are hyperfast movements that are present when slower eye movements are impaired by the disease process. These fast movement characteristics are not present in defects of eye movements due to other aetiologies.

Saccadic properties of a small group of patients with a confirmed diagnosis of MG will be measured to identify if characteristic hyperfast saccades are present.

Eligibility Criteria:
Inclusion Criteria:

Patient participants

* Confirmed diagnosis of Myasthenia Gravis by either a positive acetylcholine antibody serum test (AChR) and/or a positive single fibre electromyograph (SFEMG) test.
* Patient participants must have also had at least one episode of diplopia and/or eye movement abnormality attributed to their diagnosis of MG.

Healthy participants:

* Must have no history of eye movement abnormality
* No have no history of other auto-immune disease (specifically diabetes, Thyroid Eye Disease and Chronic External Ophthalmoplegia).

Exclusion Criteria:

* Patients without confirmed Myasthenia Gravis diagnosis by means of either a positive AChR serum test and/or a positive SFEMG test.
* Patients with confirmed Myasthenia Gravis who have not had at least one episode of diplopia and or ptosis.
* Patients with current or previous episodes of ocular motility dysfunction that have a confirmed diagnosis other than Myasthenia Gravis.
* Any healthy participant found to have an abnormality of vision or eye movement upon screening or a history of auto-immune disease.
Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer

Prospective observational study of a precision medicine approach in patients with advanced cancer. In this registrational study, patients with advanced cancer undergoing extensive molecular sequencing within the precision oncology program of Charité University Medicine, Berlin will be registered and followed to assess the efficacy of the program and assess the clinical relevance and frequency of molecular alterations, individualized therapies and novel molecular analysis tools.


Eligibility Criteria:
Inclusion Criteria:

* advanced cancer
* ability to give written informed consent
* performance status allows initiation of a potential targeted treatment after molecular analysis
* molecular analysis has been done or planned

Exclusion Criteria:

- unable to give written informed consent
Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From COPD ?

The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.

COPD patients suffer from bad sleep quality. About 27 -50% are suffering from insomnia, and respiratory related symptoms are also inducing sleep disturbances. Recently, a correlation between altered sleep quality and low activity levels have been shown in this population. In primary insomnia, it is well established that physical activity has a positive impact on sleep quality.

The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients
* able to walk and cycle

Exclusion Criteria:

* Shift work
* orthopedic diseases of limbs
Evaluation of the Validity and Reliability of the '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients Using Pacemakers

Recently, the use of Cardiac Implantable Electronic Devices (CIED) is becoming widespread due to the improvement of patients' symptoms, reduction of sudden cardiac death and improved quality of life. Although implantation of the device is considered a minor invasive procedure, possible but often underestimated dysfunction of the same side upper extremity may develop after implantation. This increase in the number of device implantations makes shoulder dysfunction after pacemaker implantation a major health problem. In the current research in the literature, arm dysfunction is evaluated by measuring range of motion with a dynamic goniometer, scales scored independently of shoulder pathology and the effect of activities of daily living. This indicates that there is no objective functional assessment method used to evaluate arm function in CIED patients. Therefore, the point of this study is to find out how reliable and valid the 6 Minute Pegboard and Ring Test (6PBRT) is for testing the functional capacity of the upper extremity in people who have had CIED implanted.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-65 who have a pacemaker,
* At least 3 months have passed since pacemaker implantation and there are no complications in the last pacemaker control,
* Being in NYHA class I-II-III,
* Patients with no coordination problems,
* Patients who volunteered to participate in the study.

Exclusion Criteria:

* Patients with a history of shoulder pathologies prior to pacemaker implantation that may restrict movement of the upper limb (conditions such as severe pain around the shoulder, edema or shoulder dislocation that may restrict upper limb movement),
* Patients with a history of shoulder surgery (limitation in range of motion),
* Patients who have had a cerebrovascular event resulting in mastectomy or arm involvement on the affected side,
* Patients with decompensated heart failure,
* Patients with a history of ICD inappropriate shock,
* Those with acute myocardial infarction,
* Patients with malignancy on active treatment, collagen tissue disease receiving systemic steroids,
* Chronic kidney disease patients on dialysis with unstable volume load.
Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder

Current therapies for Stage IV bladder cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV bladder cancer

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV bladder cancer.

Stage IV bladder cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage IV bladder cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV bladder cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IV bladder carcinoma that is unlikely to respond to existing therapy and for which no curative therapy exists or stage IV newly diagnosed, incurable bladder carcinoma
* Measurable disease by CT scan
* Tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the largest diameter for other localizations
* 18 and over
* Karnofsky 60-100%
* Life expectancy: greater than 2 months
* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3
* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT no greater than 5 times upper limit of normal
* No hepatic failure
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium
* No severe heart disease
* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium
* No severe lung disease
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No serious active infections or fever
* No other serious concurrent disease
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulating agents
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* Concurrent corticosteroids allowed
* At least 8 weeks since prior radiotherapy and recovered
* Recovered from any prior operative procedure
* Prior cytodifferentiating agent allowed

Exclusion Criteria:

- Prior antineoplaston therapy
Genicular Nerve Block in Rheuamtoid Arthritis

N=64 RA patients either early or established disease diagnosed after ACR/EULAR criteria 2010 with unilateral persistent knee arthritis. They were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. Both groups were examined by SOLAR scoring system, Visual analogue scale (VAS) and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score was used to assess tenderness and swelling at the same intervals.


Eligibility Criteria:
Inclusion Criteria:

* RA patients
* Age \> 18
* unilateral persistent knee arthritis

Exclusion Criteria:

* Participants with severe knee osteoarthritis
* peripheral neuropathy
* psoriatic arthritis
* skin infection
* or those who have allergy for Bupivacaine
Pain Management After Adductor Canal Block for Total Knee Arthroplasty

This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of the iPACK block with Adductor Canal Block on postoperative pain, functional recovery and NLR and PLR levels.

The Interspace between the popliteal artery and capsule of the posterior knee, or iPACK block, together with the Adductor Canal block (ACB), has been described and shows promise in providing analgesia to the knee joint. However, the effect of these two blocks on postoperative pain levels, functional recovery, and stress response is uncertain. This study compares a preoperative iPACK and ACB block to Sham blocks before total knee arthroplasty under spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old undergoing unilateral total knee arthroplasty

Exclusion Criteria:

* refusal to participate
* \< 18 yo
* Chronic opioid use
* localized infection
Sport Injuries During Physical Activity Lessons in Secondary School in South of Reunion Island

TsColEPS aims at identifying individual determinants of sport injuries during physical activity lessons in secondary school at reunion Island.

Sport injuries during physical activities lessons are the first etiology of traumatism in secondary school. Epidemiological studies on individual determinants of sport injuries are very scarce and most focused on contextual or mixed determinants.

TsColEPS is a multicenter case control study with one control paired to one case.

A convenience sample of 500 pupils in each group was planned on the base of a range of expected odds ratios.

Eligibility Criteria:
Inclusion Criteria:

* in secondary public school classroom in south of Reunion Island
* no age limited

Exclusion Criteria:

* none
Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

OBJECTIVES:

I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and physiotherapy.

PROTOCOL OUTLINE: Patients are treated with daily olsalazine. The dose is increased each week until the protocol dose is reached.

Supplemental acetaminophen is allowed; nonsteroidal anti-inflammatory drugs continue unchanged. Concurrent sulfasalazine is prohibited.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Meets modified New York diagnostic criteria
* Active disease, i.e., morning stiffness for more than 30 minutes
* Failed or experienced nonlife-threatening reaction to prior sulfasalazine
* No significant hematologic, hepatic, or renal disease
A Cross Sectional Disease/Condition Focused Observational Study on Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to establish the prevalence of comorbidities in Italian patients with chronic bronchitis with at least 2 exacerbations per year, and to document the appropriateness of instrumental diagnostic tests, such as spirometry of these patients.

This is an observational study so participants will only take medication that is presently prescribed by their regular healthcare provider. No additional study medication will be administered. This study will enroll patients who have been previously diagnosed with COPD. This study will look at the medical history and other diseases that have been diagnosed in people who also have COPD.

The study will enroll approximately 3000 patients.

This multi-centre trial will be conducted in Italy. The overall time to participate in this study is at a single, regularly scheduled visit at the pulmonologists office. There will not be any follow up assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Age 45-85, of either gender.
2. Signed informed consent.
3. Known COPD documented by spirometric exams showing fixed non reversible respiratory obstruction.
4. Forced Expired Volume measured after 1 second expiration (FEV-1) \< 50% in a previous test (no time limits).
5. Symptoms of chronic bronchitis : chronic productive cough for 3 months at least in each of the 2 years prior to the index visits.
6. On treatment of bronchodilators (no restrictions) for the last 12 months at least.
7. History of at least 2 exacerbations (moderate/severe) in the last 12 months prior to index visit.

Exclusion Criteria:

* None
A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.

This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects age ≥ 18 and ≤ 55 years.
* Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².
* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.

Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion Criteria:

- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.

Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)

* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
* Further exclusion criterias apply.
Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow

Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. There is evidence that electric microcurrent can promote tissue healing and symptom resolution in various chronic hard and soft tissue disorders, but few human studies have investigated its use with chronic tendon problems. It is an easily applied therapy with very few reports of side effects. It can be applied at home using a portable unit and, if it is clinically effective, may also prove more cost effective than other therapies.

A clinical trial is planned to evaluate the therapy but, in the absence of relevant published evidence, a preliminary study is required to look for a treatment effect and inform a power calculation for sample size, The study is comparing the effects of two different forms of microcurrent treatment.


Eligibility Criteria:
Inclusion Criteria:

* symptoms of tennis elbow for at least 3 months
* clinical diagnosis of tennis elbow

Exclusion Criteria:

* significant symptom improvement in previous month
* receipt of any active treatment for the condition in the previous month
* currently under the care of another health professional for tennis elbow
* current cervical radiculopathy
Assessment of Vital Pulp Therapy in Permanent Molars

The purpose of this study is to evaluate the long term clinical performance of vital pulp therapy of young permanent teeth with irreversible pulpitis

Permanent molar teeth meeting the inclusion criteria will be included into the study. Following local anaesthesia and dental dam application, caries excavation will be performed; and after exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) using a sterile high-speed round bur under water coolant. After haemostasis is achieved, Mineral trioxide aggregate (MTA) will be gently placed over the pulp to a thickness of 2-3 mm and the tooth will be restored using glass ionomer cement and composite resin. A postoperative periapical radiograph will be taken. Patients will be reviewed at 6., 12., 24. and 36. months for clinical and radiographical success. The data will be analysed statistically using chi square test.

Eligibility Criteria:
Inclusion Criteria:

* Patients and parents of the patients who accept to participate and sign the informed consent
* Patients who have at least one vital permanent molar teeth with irreversible pulpitis symptoms
* Teeth which can be restorable after the treatment.
* Teeth which has good periodontal health and in the absence of sinus tracts or swelling.

Exclusion Criteria:

* Patients and parents of the patients who does not accept to participate and sign the informed consent
* Teeth which have dentoalveolar or extraoral swelling
* Teeth which have periodontal disease, mobility or alveolar bone loss
* Teeth which are not restorable
* Patients who are not cooperative with the treatment
Seroprevalence of SARS-Cov-2 Antibodies in Children

It is unknown what proportion of healthy children have been exposed to SARS-Cov-2 and how many have antibodies. The aim of this study is to follow a cohort of healthy children over six months and measure their antibodies to SARS-CoV-2.

Coronaviruses are non-segmented positive-stranded RNA viruses with a roughly 30 kb genome. The majority of coronaviruses cause disease in a specific host species but some have infected humans by cross-species transmission. This process has led to a number of severe outbreaks of human disease including severe acute respiratory syndrome (SARS) in 2003 and Middle East respiratory syndrome (MERS) in 2012.

From December 2019 a novel infection "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2) was identified in the Wuhan region of China. The infection was identified as the causal factor in a growing number of severe cases of pneumonia. This disease was subsequently named coronavirus disease 2019 (COVID-19) by World Health Organisation (WHO). SARS-CoV-2 has been shown to cause severe disease similar to the previous SARS coronavirus from 2003. Severe disease is associated with pneumonia and damage to vital organs including lung, heart, liver, and kidney.

Fortunately SARS-CoV-2 appears to cause only mild, or no, symptoms in children.

The social distancing measures in the United Kingdom include the closure of schools and the cancelling of routine paediatric clinics. These drastic, but necessary, steps are likely to have a profound effect on the well-being of children.

This study is required to determine what proportion of children have been exposed to SARS-Cov-2 and how many, if any, have neutralizing antibodies. The findings from this study could be used to inform public health decisions regarding the re-opening of schools and other services vital to the well-being of children.

In addition the study will recruit children with paediatric multi-system inflammatory syndrome admitted to the Royal Belfast Hospital for Sick Children along with matched controls with other infections.

Eligibility Criteria:
Healthy children of healthcare professionals.

Exclusion Criteria:

Not currently receiving antibiotics, not admitted to hospital within the last seven days, not receiving immunosuppressive drugs and never diagnosed with a malignancy.

Admitted children with paediatric multisystem inflammatory syndrome and admitted children with other serious infections.
Genetic Characterization of Cardiomyopathies (POLICARDIOMIO2021)

Cardiomyopathy refers to a diverse group of myocardial diseases with multiple causes. In 1995, the World Health Organization classified cardiomyopathies into hypertrophic, dilated, restrictive, and mixed type. This classification is based on the pathophysiology of the disease. However, with rapid evolution of molecular genetics in cardiology, the American Heart Association in 2006 has classified cardiomyopathies into two major groups based on predominant organ involvement and etiology; Primary cardiomyopathies are those solely or predominantly confined to heart muscle and are relatively few in number. Secondary cardiomyopathies show pathologic myocardial involvement as part of a large number and variety of generalized systemic (multiorgan) disorders.Current evidence supports the use of genetic testing in clinical practice to improve risk stratification for clinically affected patients and their at-risk relatives for cardiomyopathies.


Eligibility Criteria:
Inclusion Criteria:

* Presence of structural cardiomyopathy
* First degree relatives for cardiomyopathy

Exclusion Criteria:

* Age \> 80
* Presence of sufficient conditions to explain the clinical condition of cardiomyopathy
* Peripartum cardiomyopathy