cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Levels in Patients With Central Retinal Vein Occlusion- a Prospective Controlled Study

Retinal vein occlusion (RVO) is a common vascular disease of the eye. Studies have shown that the risk of venous thrombosis is higher in winter so even concerning RVO. Studies have shown a possible link between sun exposure and venous thrombosis. Vitamin D levels have been shown to have a similar seasonal variation, with a peak occurring in the summer. The primary source of vitamin D is from sunlight when ultraviolet B (UVB) radiation penetrates the skin and converts 7-dehydrocholesterol to 25-hydroxycholecalciferol vitamin D3 (25-OHVitD) via previtamin D. In Stockholm situated at latitude 59˚ 20΄ North, it is not possible to synthesize vitamin D at sufficient levels in winter and the exposure time required to reach a standard dose is impractical from at least October through March.

The aim of the study is to evaluate vitamin D levels in central retinal vein occlusion (CRVO) patients and compare them with the vitamin D levels in randomly selected control patients matched for age and month of disease onset. This is to evaluate whether vitamin D deficiency may be a risk factor in the onset of CRVO.

The hypothesis of the study is that patients with CRVO have lower levels of vitamin d than matched controls.

The study will last one year and is expected to include 120 patients with RVO and 120 control patients. The first 10 RVO patients visiting St. Erik's Eye Hospital with disease duration of maximum 3 months will be included in the study each month. The control patients will be chosen randomly by the Central Bureau of Statistics and matched for age and gender according to disease distribution known from previous studies. The control group will receive a letter with information of the study, informed consent form and details about the blood sampling procedure. Every month 50 patients in the control group will be invited to participate in the study. Only the first 10 control subjects will be included in the study. Each month a blood sample will be taken from 10 patients with RVO and 10 subjects in the control group. All the subjects will only have one blood sample taken during the study. Blood will be analyzed to measure the vitamin D level. Vitamin D levels will be compared at the end of the study between groups and evaluated according to the time of year for sampling. All the blood sampling will be done by the laboratory at Karolinska University Hospital. Participation in the study is completely voluntary. The details of the study has been reviewed and approved by the Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed central retinal vein occlusion (3 months)

Exclusion Criteria:

-
Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor

The objective of this study is to assess the inoculation-related symptoms and long-term effects of COVID-19 vaccines in patients with lung cancer or pulmonary nodules in a real-world setting. The investigators aim to provide high-quality evidence for the COVID-19 vaccines in cancer/pre-cancer patients, and to address their concern about the safety profile of the newly developed vaccines.

This study will enroll lung cancer/pulmonary nodule patients or healthy people who had undergone standard vaccination procedures against SARS-CoV-2/COVID-19. This observatory study will apply an electronic questionnaire to collect general information and post-vaccination symptoms or adverse events of vaccinated pulmonary nodules/lung cancer patients and healthy control. The researchers will further analyze whether the vaccine will promote the progression of primary tumors/pulmonary nodules through long-term follow-up. The investigators aim to assess the adverse events and long-term impact of COVID-19 vaccines in patients with lung cancer or pulmonary nodules in a real-world setting, to provide high-quality evidence for the COVID-19 vaccines in cancer/pre-cancer patients, and to address their concern about the safety profile of the newly developed vaccines.

Eligibility Criteria:
Inclusion Criteria:

1. Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who have been vaccinated against the SARS-CoV-2
2. Pulmonary nodule/lung cancer patients confirmed by CT or pathological examination, who are not vaccinated against the SARS-CoV-2
3. Healthy people who have been vaccinated against the SARS-CoV-2

Exclusion Criteria:

1. Multiple malignancy in other parts of body;
2. Infected with SARS-CoV-2 virus currently or in the past;
3. Refuse to participate in this study.
Role of L-citrulline in Prevention of Pregnancy Associated Hypertension

The target population for our study is healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy.

If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily L-citrulline supplementation or placebo.

Healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy will be eligible for this study. The purpose of this study will be to determine if daily supplementation of oral L-citrulline can reduce the incidence of pregnancy induced hypertension. This will be a double blind study, subjects will be randomized to receive either L-citrulline (3 gram sachet) or a placebo for a total of 8 weeks. Participants will be asked to provide urine and blood samples at time of enrollment, be asked to respond to a phone survey to assess for side effects, and again be asked to provide urine and blood samples at the end of 8 weeks. Participants will continue with routine prenatal care throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous (no previous pregnancy greater than 20 weeks)
* Gestational age of pregnancy between 12 and 16 weeks

Exclusion Criteria:

* Known fetal anomaly or chromosomal abnormality
* Early fetal growth restriction
* Fetal demise or planned termination
* Participation in another study that may influence this study
* Known maternal kidney disease
* Known maternal electrolyte imbalance
* Known allergies to study interventions
* Preexisting hypertension (chronic hypertension)
* Known gastric ulcer
* Incarcerated status
* Planned delivery at non-UTMB hospital
* Known lactose intolerance
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=50 years of age;
* probable Alzheimer's disease;
* MMSE score at screening of 13-22;
* under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for \>=4 months prior to baseline;
* not requiring nursing home care, but looked after by a caregiver/carer.

Exclusion Criteria:

* dementia due to condition other than Alzheimer's disease;
* other significant neurological disorder;
* untreated/non-stabilized major depressive disorder;
* bipolar disorder, schizophrenia, or any other serious psychiatric condition.
Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma

This is a study for patients with advanced testicular cancer. This research study involves treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational chemotherapy combination. This study is for patients who have not responded to standard cisplatin-containing chemotherapy or the cancer has returned after such treatment.

This research is being done to assess the effectiveness of the proposed combination of medications for this type of cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure
2. Must have refractory germ cell neoplasm defined as one or more of the following:

   * patients who progress during or within 4 weeks of cisplatin-containing tx, OR - patients who have failed initial salvage chemotx regimens, including high-dose tx (chemotx with stem cell support), POMB-ACE tx, VeIP, or VIP
3. Must have one or more of the following (check all that apply):

   * unidimensionally measurable doze assessed within 14 days prior to registration,
   * elevated β-HCG \> 20 mIU assessed within 24-48 hours prior to registration, OR
   * AFP \> 2 x uln assessed within 5-7 days prior to registration

   Note: Soft tissue dz, which has been radiated in the 2 months prior to registration, is not assessable as measurable dz.
4. X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration
5. May have received prior surgery or RT. At least 3 weeks must have elapsed since completion of previous tx and must have recovered from any adverse effects
6. Zubrod PS less than or equal to 2
7. Greater than or equal to 16 years of age
8. AGC greater than or equal to 1.5; platelets greater than or equal to 100,000
9. Total bilirubin \< 2.5 x uln; SGOT and alk phos \< 5 x uln (obtained within 14 days prior to registration)
10. LDH (obtained within 7 days prior to registration)
11. Creatinine \< 2.5 x uln or calc or meas CrCl greater than or equal to 40 ml/min (obtained within 14 days prior to registration; patient must not be on renal dialysis)
12. Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration)
13. Men of reproductive potential must agree to use effective contraceptive method
14. Signed informed consent (including HIPAA authorization)

Exclusion Criteria:

1. Prior tx with cytotoxic or experimental agents within 14 days prior to registration
2. Evidence of concurrent infection (T \> 96.8F but \< 101.5F; WBC \< 11.0 unless these values can be ascribed to another tumor-related phenomena)
3. Other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which patient is currently in chemoradiation (CR), or any other cancer from which patient has been disease-free for 5 years
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Born at term (\>36 weeks gestation)
* 2 months to \<4 years of age at enrollment
* Documented CMA within 6 months prior to enrollment
* Otherwise healthy
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Children consuming mother's milk at the time of inclusion and during the trial
* Any chromosomal or major congenital anomalies
* Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
* Immunodeficiency
* Receiving free amino acid formula
* Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
* Currently participating in another clinical trial.
Italian Multicenter Retrospective Observational Study on Transformed Lymphomas

Study purpose is to evaluate treatment outcome and survival in patient with aggressive lymphomas transformed from Follicular Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed transformed Follicular Lymphoma
* Age \> 18 years
* Histological transformation between January 2002 and December 2014
* Availability of data about treatment and outcome

Exclusion Criteria:

* Other lymphoma diagnosis
Quality of Life Study Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent

In the context of radiotherapy, control of breakthrough pain represents a special challenge. Patients undergoing radiotherapy may experience different situations of pain that may be due to the need to remain immobilized during radiotherapy session, the need to wear an immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation after the development of proctitis, or sudden pain during the night causing sleep disturbances.

In a survey conducted in radiation oncology services more than half of patients treated with radiotherapy experienced pain, and 39% of patients reported that their pain was not treated properly. This situation may increase the patient's anxiety, dissatisfaction with treatment, affect their quality of life and can even come to refuse radiotherapy treatment.

This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in radiotherapy services in Spanish hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Cancer Patients
* Patients attended in radiation oncology consultations with palliative intent
* Life expectancy \> 6 months
* Written informed consent
* Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm

Exclusion Criteria:

* Untreated patients with opioids for baseline pain
* Patients who are not opioid tolerant
* Serious psychiatric disorder or any disease or condition that prevents the collection of data
* Patients with evidence of opioid addiction or history of drug or alcohol abuse
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction

The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.


Eligibility Criteria:
Inclusion Criteria:

* History of pain due to medial osteoarthritis
* Qualifying baseline pain scores
* Kellgren-Lawrence Grades 2-3

Exclusion Criteria:

* Osteoporosis
* Rheumatoid arthritis
* Joint instability
* Metal ion allergy
* Permanent implant in or around the knee joint
* Prior anterior cruciate ligament reconstruction
Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients

The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and 90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.

Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide, Heliox 28 and oxygen.

Conventional oxygen supplementation is often used in these patients, but it may be inadequate, especially if they require high flows (from 30L/min to 120L/min in acute respiratory failure).

High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which generates the gas flow rate up to 55 L/min and a heated humidification system. This technology may have an important role in reducing respiratory distress in do-not-intubate patients.

Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen concentration; a better matching between patient's inspiratory demand and oxygen flow; generation of a certain level of positive pressure (PEEP) contributing to the pulmonary distending pressure and recruitment; improvement of lung and airway mucociliary clearance due to the heated and humidified oxygen; and patient's comfort because of the nasal interface allowing feeding and speech.

The investigators hypothesize that patients supported with HFONC need less opioids to decrease dyspnoea.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients who had end-stage lung disease (lung cancer, pulmonary fibrosis, COPD, ...) - (McCabe score \> 3 \[\<6 months life expectancy\] and a Palliative Prognostic Index score ≥ 4) admitted to hospital because of acute respiratory failure and distress
* Had chosen to forego all life support and receiving only palliative care
* Severe hypoxemia (PaO2/FiO2\< 250)
* At least one of the following: dyspnoea (Borg scale ≥4), signs of respiratory distress, and respiratory rate greater than 30 beats per min

Exclusion Criteria:

* Patients had to be competent (Kelly score \<4)
* Refusal of treatment
* Weak cough reflex
* Agitation or non-cooperation
* Uncontrolled cardiac ischemia or arrhythmias
* Failure of more than two organs
* Use of opioids within the past 2 weeks
* Adverse reactions to opioids
* History of substance misuse
* Known contraindication for morphine (acute renal failure and recent head injury)
Pre-procedural Information Sheet Reduces Anxiety of Patients Before Urodynamic Studies

Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is that pre-procedural explanation note about the test may reduce the anxiety level of the patients.

Urodynamic study is one of the most common procedures in urological outpatient practice. Patients who wait for the tests may experience significant anxiety.

in this study, patients who are designated to have multichannel Urodynamic study will be randomized to two groups: group 1 - patients who received an explanation note about the test; group 2 - patients who did not receive the note. The explanation notes will be sent to the patients in group 1 by mail one month before the test.

Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress immediately before the test. Comparison opf the anxiety level between the two groups will be performed.

Eligibility Criteria:
Inclusion Criteria:

All patients who will be referred for Urodynamic studies in order to evaluate lower urinary tract symptoms.

Exclusion Criteria:

1. inability to complete the questionnaire due to mental disorders
2. patients who had undergone Urodynamic study previously
Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab

The primary purpose of this study is to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab in participants who are prescribed and are receiving a higher than approved dose of eculizumab to treat paroxysmal nocturnal hemoglobinuria (PNH).


Eligibility Criteria:
Key Inclusion Criteria:

1. Documented diagnosis of PNH, confirmed by high-sensitivity flow cytometry evaluation of red blood cells and white blood cells, with granulocyte or monocyte clone size of ≥ 5%.
2. Received 1200 mg eculizumab every 12 to 16 days (every 2 weeks) for at least 3 months prior to Screening.
3. LDH ≤ 2 x upper limit of normal (ULN) according to central laboratory, at Screening.
4. To reduce the risk of meningococcal infection (Neisseria meningitidis), all participants must be vaccinated against meningococcal infections within 3 years prior to initiating study drug.
5. Body weight ≥ 40 kilograms.

Key Exclusion Criteria:

1. History of major adverse vascular events within 6 months of Day 1.
2. History of bone marrow transplantation.
3. Lymphoma, leukemia, myelodysplastic syndrome, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
4. Concomitant use of anticoagulants is prohibited if not on a stable regimen for at least 2 weeks prior to Day 1.
5. Concomitant use of any of the following medications and not on a stable regimen (as judged by the Investigator) for the time period indicated prior to Screening:

   * Erythropoietin or immunosuppressants for at least 8 weeks
   * Systemic corticosteroids for at least 4 weeks
   * Vitamin K antagonists (for example, warfarin) with a stable international normalized ratio level for at least 4 weeks
   * Iron supplements or folic acid for 4 weeks
6. Live vaccine(s) within 1 month prior to Screening or plans to receive such vaccines during the study.
7. More than 1 LDH value \> 2 × ULN within the 6 months prior to Day 1.
8. Platelet count \< 30,000/cubic millimeter (30 × 10\^9/Liter \[L\]) at Screening.
9. Absolute neutrophil count \< 500/microliter (0.5 × 10\^9/L) at Screening.
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose \> 4 years.

The hypothesis of the present study is that dental implant therapy using submerged healing is feasible and predictable in patients receiving high, adjuvant or low dose AR for more than 4 years, as documented by clinical and radiographic signs of osseointegration after 3-4 months, sufficient implant stability for abutment connection, and implant survival rates comparable to those of healthy individuals after one year of prosthetic loading.

Eligibility Criteria:
Inclusion Criteria:

* Patient with cancer or osteoporosis, treated with antiresorptive treatment.
* The patients should have sufficient compliance, this includes willingness to have the planned assessments
* The patient should have an expected life span at enrollment of at least 2 years.
* The local bone quality and quantity should be sufficient for implant insertion without bone augmentation and is classified according to the classification by Cawood \& Howell 1988.

Exclusion Criteria:

* \> 10 cigarettes daily
* HbA1c \> 53 mmol/mol
* Poor oral hygiene
* Poor general condition: ECOG score 3 or 4.
* Poor prognosis: Expected survival \<2 year is an exclusion cause.
* Presence of metastases of the liver brain.
* Poor local jaw bone quality acc. to Cawood classification stage 3 or 4.
* Unwillingness to comply with the planned assessments and recordings
Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry

This will be a registry study that will enroll patients referred for an ECG treadmill test with nuclear myocardial perfusion imaging (MPI). The high frequency QRS (HFQRS) information will be recorded and analyzed automatically and simultaneous with the standard ECG signals by the HyperQ System. Results of subsequent tests performed on each patient will be collected and used to enhance the reliability of designating each patient as a CAD-negative (i.e., no significant coronary artery disease) or a CAD-positive (i.e., significant coronary artery disease).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Referred for exercise MPI due to suspected coronary artery disease

Exclusion Criteria:

* Acute Coronary Syndrome (Unstable angina/NSTEMI/STEMI)
* Pre-excitation syndrome
* QRS duration \> 120 ms
* Atrial Fibrillation or significant ventricular arrhythmia
* Treatment with Digoxin
* Pacemaker with 100% pacemaker dependence