cyrilzakka/clinical-trials huggingface dataset:
Multiple Sclerosis and Fatigue Assessment

Fatigue in patients with Multiple Sclerosis (MS) is a problem that is seen without physical exertion and affects the majority of patients. In studies on fatigue in the literature, it has been seen that subjective methods are frequently used by using evaluation scales based on patient statements, but objective evaluation methods are not yet sufficient. This study was planned to compare the measurement results by evaluating fatigue subjectively, objectively and cognitively in MS patients.

Multiple Sclerosis (MS) is a chronic, inflammatory, demyelinating, autoimmune disease of the central nervous system. It is characterized by clinical symptoms arising from lesions in the brain, spinal cord or optic nerves. Although fatigue is one of the most common and most disabling problems of individuals with MS, it is not yet fully understood. This affects the treatment and disease process in MS. Despite studies to elucidate the pathogenic mechanisms of fatigue, available information is limited. Several factors contribute to the limited fatigue research, but the most important is that 'fatigue' is often not clearly defined or meaningful measures cannot be made in clinical/research settings. The first step in the evaluation of fatigue, which is a complex symptom, is to start with the identification and analysis of the factors that may cause fatigue, and to comprehensively question the factors that may be effective and the patient's history, and to evaluate the fatigue subjectively and objectively after the comprehensive patient history. The fatigue of patients diagnosed with MS will be evaluated subjectively, objectively and cognitively. Other information about the disease of the patients will be recorded. Subjective fatigue assessment methods, objective fatigue assessment methods and cognitive fatigue assessment methods will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Having a definite diagnosis of Relapsing Remitting MS by a neurologist,
* Expanded Disability Status Scale (EDSS) score between 1-5.5,
* To be stable in medical treatment,
* Being able to stand independently for at least 60 seconds without any assistive device,
* It is to be above 24 points according to the Mini-Mental State Examination (MMSE) evaluation.

Exclusion Criteria:

* Being diagnosed with MS for less than 1 year,
* Having had an MS attack in the last 3 months,
* Being illiterate or unable to communicate in Turkish,
* Having an active infection,
* Being pregnant,
* Having an orthopedic problem or having a surgery that may affect the lower extremity,
* Having an additional neurological or circulatory disease that may cause balance disorder, a problem affecting the vision or vestibular tract, or a diagnosis of orthopedic surgery, rheumatological disease,
* To be included in the physiotherapy and rehabilitation program in the last 3 months.
Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors

This study is an open-label, multicenter study for Continued Characterization of Safety and Tolerability of TT-00420 (tinengotinib) Tablet Monotherapy in Adult Patients with Advanced Solid Tumors

This is a Rollover study. Only subjects who continue to receive clinical benefit from continuation of tinengotinib monotherapy and are tolerating tinengotinib at the time of enrollment are eligible to participate on this study. Subjects on this rollover study may continue to receive tinengotinib at the dose that they were previously receiving on the TransThera parent study and may continue for as long as the subject continues to benefit from treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is currently enrolled in a pre-defined TransThera-sponsored parent study and is receiving tinengotinib as a single agent.
2. Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.

Exclusion Criteria:

1. Subject has been permanently discontinued from tinengotinib in the parent protocol for any reason other than enrollment in the Rollover study
2. Subject does not meet the criteria specified in the parent protocol for continued treatment on study.
Suboptimal Responders to Adefovir Switching to Entecavir

Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir


Eligibility Criteria:
Inclusion Criteria:

* Chronic infection with hepatitis B virus (HBV)(detectable hepatitis B surface antibody (HBsAg) at screening and at least 24 weeks prior to screening, or detectable HBsAg for \<24 weeks and negative for immunoglobulin M core antibody)
* Documentation of hepatitis B e antigen (HBeAg) positive or negative status
* Naive to nucleoside/nucleotide analogues, with the exception of adefovir
* Suboptimal response to adefovir treatment
* No lamivudine/telbivudine, entecavir, or adefovir resistance-associated substitutions at screening
* Male or female gender, aged 16 years and older
* Compensated liver function
* Serum alanine aminotransferase level \<10\*upper limit of normal at screening

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Evidence of decompensated cirrhosis
* Coinfection with HIV, hepatitis C virus, or hepatitis D virus
* Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)
* Chronic renal insufficiency, defined as a creatinine clearance \<50 mL/min
* Current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
* Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
* Serum creatinine level \>1.5 mg/dL; hemoglobin level \<10.0 g/dL; platelet count \<70,000/mm\^3; absolute neutrophil count \<1500 cells/mm\^3; serum alpha fetoprotein level \>100 ng/mL
* Except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (eg, lamivudine, entecavir), or any other experimental anti-HBV antiviral, or any China Traditional Medicine
* Therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization
* Required chronic administration of medications that cause immunosuppression, that are associated with a high risk of nephrotoxicity or hepatotoxicity, or that affect renal excretion.
Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.


Eligibility Criteria:
Inclusion Criteria:

* Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1
* HCV RNA viral load of ≤10\*5\* IU/mL (100,000 IU/mL)
* Body Mass Index (BMI) of 18 to 35 kg/m², inclusive

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection
* Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study
Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol

To prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. However, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. Furthermore, the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature.

Since the beginning of the 2000s, the reference treatment for the management of aneurysmal subarachnoid haemorrhage consists of interventional neuroradiology with coil embolization of the aneurysm. Although ensuring a better neurological prognosis than neurosurgical clipping, interventional neuroradiology exposes the patient to various risks: thromboembolic complications during or after embolization and re-rupture of the aneurysm during embolization. To prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. However, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. Furthermore, the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years undergoing one of the following interventional neuroradiology procedures at Amiens University Hospital: elective embolization of an intracranial aneurysm, emergency embolization of a ruptured intracranial aneurysm, elective or urgent embolization of an intracranial or perispinal arteriovenous malformation.

Exclusion Criteria:

* Patients in whom all modalities of monitoring of the efficacy of anticoagulation (laboratory tests and point-of-care tests) were not performed, incomplete embolization or radiological follow-up records.
* Patients presenting a contraindication to the administration of unfractionated heparin: history of heparin-induced thrombocytopenia or haemorrhagic coagulopathy (von Willebrand disease, haemophilia).
Secondary Prevention With the Lifestyle Tool

In this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. The investigators will prospectively follow the incidence of major cardiovascular events in patients who have previously suffered from a myocardial infarction in those using the tool regularly and those in the control group.

Cardiovascular disease (CVD) remains a leading cause of death in most European countries, and new strategies for prevention are urgently needed.

Previous studies on primary and secondary prevention have shown that lifestyle interventions can affect risk factors for CVD and reduce cardiovascular morbidity and mortality. Many prevention programmes are, however, time-limited and fail to provide continuous support. They also require substantial costs and healthcare resources. Furthermore, accessibility to primary and secondary cardiac prevention programmes is highly variable, as is long-term adherence to lifestyle advice.

In light of this, international associations have emphasized the need for innovative, scalable and cost-effective lifestyle interventions that could be integrated into pre-existing healthcare structures. Digital tools have large potential for clinical utility, but there are several important knowledge gaps. First, data on long-term efficacy is scarce. Second, most studies to date have included only small number of individuals, and there is a need for large randomized controlled studies. Third, cost-effectiveness remains to be demonstrated.

The objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes.

In individuals who have previously suffered from a myocardial infarction the investigators will test the hypothesis that those who access to the tool have lower incidence of further major cardiovascular events (MACE) compared with control individuals.

The study is an investigator-initiated single-center study conducted over three years.

The tool is web-based and used via a computer or mobile phone. It is used at each individual's preferred pace but participants are recommended to login at least every other week. Every round the participants choose a themes (out of appr. 80 possible covering e.g. food, exercise, stress, self-reflection aspects), which takes appr. 15-30 minutes to complete. Participants then reflect on the content and how it could be implemented in daily life. When returning for next round participants are asked to reflect on any changes done since last time.

Eligibility Criteria:
Inclusion Criteria:

* age 35 to 80 years
* myocardial infarction within one year prior to enrolment
* access to computer or mobile phone.

Exclusion Criteria:

* conditions or treatments that in the judgement of the Investigator could affect the study evaluation
Once-A-Day Pregabalin For Partial Seizures

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
* Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion Criteria:

* Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
* Status epilepticus within one year prior to screening
Methodological Study to Compare the Effect of Different Methods of Measuring Cat Allergy Symptoms in Patients That Have Immunized Their Cats With FEL-CMV.

In this Project we will monitor the symptoms of cat allergic participants who live together with a cat which is immunized with FEL-CMV using the novel symptom recording method "HypoScore", a General weekly symptom score, and a skin prick test before and after immunization of the cat. This project may enable us to determine if the scoring System and the tests are able to detect a difference in participant symptoms before and after immunization of the cats.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent after participants' information
* 18 to 65 years, male or female
* Participant understands the nature, meaning and scope of the study
* Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/ml
* Positive screening prick test (mean wheal diameter ≥ 3 mm) when tested with already standardized cat allergen extract
* Positive screening scratch test when tested with cat dander sample of participant's cat.
* Living with a cat in the same household and parallel participation in the cat study in which the cat will be immunized
* A positive clinical history with inhalant allergy presumably due to cat allergen

Exclusion Criteria:

* Immunosuppression or haematological diseases, in particular anaemias or leukaemia
* Other previous or current condition or participation in clinical trials influencing the results of the present study by discretion of the investigator
* Incapable of understanding the nature, meaning or scope of the research project or incapable of giving written informed consent
* Unwilling or incapable of following the study procedures, e.g. due to language problems, psychological disorders, dementia, known or suspected drug or alcohol abuse etc.
* Women who are pregnant or breast feeding or having the intention to become pregnant during the course of the study
* Positive skin reaction in the screening prick test to negative control
* History of anaphylactic reaction to pet allergens
* Severe diseases influencing the results of the present study by discretion of the investigator
* Immunotherapy with Fel d 1 / cat allergen preparation during the past two years.
* Skin lesions and excessive hair growth in the skin test areas
* Treatment with prohibited concomitant medications with the exception of medications with local effects which will not influence the results of the skin tests and the results of the other tests (testing period)
* The participant should not suffer from other respiratory allergies during this study (people who suffer from asthma are not excluded)
Alere Triage fs B-type Natriuretic Peptide (BNP) Method Comparison Evaluation

This study will evaluate method correlation and mean bias between six B-type natriuretic peptide (BNP) platforms.


Eligibility Criteria:
Inclusion Criteria:

* Samples with BNP range of 5-5000 pg/ml
* Samples with sufficient volume for testing

Exclusion Criteria:

* BNP \<5 pg/ml
Campus Life Study: Harnessing Generativity Among Young Adults

Recent research suggests that short, online interventions can enhance well-being, which is beneficial to both physical and mental health outcomes. Further, growing evidence suggests that prosocial behavior-a behavior that can be reliably manipulated through a short online intervention-may have beneficial effects on well-being and physical health. Giving support to others appears to be just as beneficial as receiving support, and asking people to perform kind acts for others over the course of several weeks, for example, has been shown to both increase well-being and reduce the inflammatory potential of immune cells.

The purpose of the current study is to test a novel 3-week, online prosocial writing-based intervention in a sample of young adults. Previous intervention studies have manipulated prosocial behavior by asking participants to perform tangible acts of kindness for others, such as writing a note to a coworker or helping a neighbor. However, providing this type of direct support can be logistically challenging and may contribute to increased feelings of distress in certain contexts. Writing interventions designed to elicit feelings of generativity offer one alternative approach, though they have yet to be tested among young adults.

Participants (n = 200) will be randomized to one of two conditions--peer helping or a facts-only control--and instructed to write about their experiences in their first-year at UCLA (freshman or first-year after transfer). Those in the peer helping will be asked to write for the benefit of a student who is about to begin their first year, whereas those in the facts-only control will not. In total, participants will complete 4 writing assignments, each on a separate day over the course of one week. Valid self-report measures will be assessed at pre-intervention, each writing session, post-intervention, and at the 2-week follow-up. The investigators expect participants in the peer helping condition to experience a greater increase in well-being (primary outcome) across the intervention and the follow-up when compared to the control condition. Secondary outcomes will include depressive symptoms, anxiety, loneliness, physical symptoms, social support, and generativity. As an exploratory aim, will also assess several moderators (i.e., psychological distress, prosocial tendencies, generativity) and mediators (i.e., fulfillment of psychological needs, positive affect) of the intervention effects.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in an upper-division psychology course
* 18 years of age or older
* fluent in English
* access to the internet and email

Exclusion Criteria:

* none
Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer

The objective of this phase I study is to determine the maximum tolerated dose (MTD) of combination therapy of paclitaxel and everolimus in small cell lung cancer patient with previous treatment history.

Small cell lung cancer (SCLC) accounts for 15% to 20% of all lung cancer, and more than half of these patients are diagnosed with extensive-stage disease (ED). SCLC is a particularly aggressive form of lung cancer with a tendency for rapid tumor growth, early dissemination and high frequency of the metastasis In this study, we evaluate the MTD of everolimus combined with paclitaxel combination chemotherapy in SCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed small cell lung cancer
2. Regarding a limited disease, the disease in a patient, who had concurrent chemoradiation therapy before, is relapsed or progressing, the patient should have received the first line platinum-based anticancer therapy. The disease should be progressing/relapsed during or after the previous treatment.
3. Regarding an extensive disease, the progression/relapse of the disease during or after the first line platinum-based anticancer therapy should be confirmed.
4. Patient with asymptomatic or treated brain metastasis.
5. Patients without current concomitant chemotherapy
6. Patients without current concomitant radiotherapy
7. Patients who are not receiving chronic treatment with steroids or another immunosuppressive agent.
8. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST).
9. Patients aged 18 years or older
10. ECOG performance status 0-2
11. Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; hemoglobin \> 9g/dL; -; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min.
12. Patients who signed and dated the informed consent form prior to specific study procedures.
13. Patients who can comply with the scheduled follow-up and toxicity management procedure.'

Exclusion Criteria:

1. Patients with history of treatment with mTOR inhibitors
2. Pregnant with gastrointestinal problem impairing absorption of drugs
3. Patients who could not use appropriate method of contraception
4. Pregnant or feeding patients
5. Other medically ill patients
6. Severe heart/pulmonary disease
7. DM patients
8. Other malignancy except cured skin cancer or uterine cervix carcinoma in situ
9. High cholesterolemia greater than grade 3
10. Patients with symptomatic brain metastasis
11. Chronic hepatitis or liver cirrhosis (patients with HBsAg positive, IgM anti-HBc positive or HCV Ab positive)
12. Patients receiving immunosuppressant
Portal Vein Pulsatility Index to Assess Fluid Intolerance

This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.

This prospective observational study aims to use the portal vein pulsatility index (PVPI) to assess fluid intolerance in fluid responders. The investigators will enroll mechanically ventilated postoperative adult patients within 6 hours of ICU admission after cardiac surgery. Patients will undergo a Passive Leg Raising (PLR) test and Left Ventricular Outflow Tract (LVOT) recording using transthoracic echocardiography. The main objective is to predict fluid intolerance after a fluid challenge of 7 ml/kg Ringer Lactate over 10 minutes in initially tolerant fluid responders.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent.
* Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics.
* Sinus rhythm.

Exclusion Criteria:

* A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis).
* Any mechanical circulatory support.
* Cardiac transplant.
* Poor transthoracic echocardiographic window.