cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Bevacizumab (Avastin) With Thoracic Radiation in Non-small Cell Cell Lung Cancer

In spite of the use of radiation combined with conventional chemotherapy, the long-term survival prognosis for most patients with locally advanced non-small cell lung cancer is disappointing. Much effort is currently focussed on exploring new molecular targeted agents that may improve upon survival. The addition of an agent that targets blood vessel formation in tumors, bevacizumab or Avastin, to conventional chemotherapy has been shown to improve survival in metastatic non-small cell lung cancer. Data from animal studies have shown that bevacizumab and related agents also increase tumor cure rates when administered both during and after radiotherapy. This suggests that combined bevacizumab and chemo-radiation may improve survival in local-advanced disease as well. Before such clinical studies can commence, the safety and normal tissue toxicity profile of bevacizumab with thoracic radiotherapy must first be established. In this study, escalating doses of bevacizumab will be administered during radiotherapy, followed by maintenance bevacizumab.


Eligibility Criteria:
Inclusion criteria:

1. Cytologically or histologically confirmed stages II or III non-squamous NSCLC
2. No evidence of tumour invading major blood vessels and no active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to randomization.
3. No prior systemic therapy for NSCLC. Prior surgery and/or extra-thoracic irradiation is permitted.
4. Presence of at least one measurable target lesion
5. Age 18 or greater.
6. WHO performance status of 0 or 1.
7. Acceptable pulmonary function as defined by a Fev1 of ≥30% and a DLCO of ≥40% of predicted
8. Life expectancy of at least 12 weeks.
9. Adequate hematological, renal and hepatic functions

   * Absolute neutrophil count \>2x109/l.
   * Platelet count \> 100x109/l.
   * Total bilirubin \< 1.5 x UNL
   * ASAT/ALAT \< 2 x UNL
   * Alkaline phosphatase \< 5 x UNL
   * Creatinine \< 130 μmol/L
   * Creatinine clearance \> 60 ml/min; measured or calculated
10. Urine dipstick for proteinuria \< 1+. If urine dipstick is ≥ 1, 24 hour urine must demonstrate \< 500 mg of protein in 24 hours.
11. No pre-existing sensory neurotoxicity grade 2 (CTC)
12. No active (uncontrolled) infection requiring antibiotics

Exclusion criteria:

1. Mixed tumor types with small cell lung cancer or squamous cell carcinoma
2. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension
3. Serious non-healing wound or ulcer.
4. ASAT and ALAT \> 1,5 x UNL
5. alkaline phosphatase 5 x UNL
6. Evidence of bleeding diathesis or coagulopathy.
7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
8. Participation in other trial with investigational drug or treatment modality.
Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study

The goal of this clinical trial is to determine if triple inhaled therapy with Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.

The main questions it aims to answer are:

* Does BGF demonstrate a comparable effect to FUV in COPD participants?
* What medical problems do participants experience when taking BGFand FUV?

This study is a randomized crossover study. COPD patients aged 40 years or older with stable disease are included. Each patient receives four weeks of treatment with either BGF or FUV followed by a one-week washout period, and then four weeks of treatment with the other drug. Respiratory symptoms are assessed using modified Medical Research Council (mMRC) dyspnea scale and COPD Assessment Test (CAT). Pulmonary function is assessed by spirometry with bronchodilator testing, and adverse events were recorded. Spirometry data, including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced expiratory flow at 25-75% of FVC (FEF25-75) are also collected. Impulse oscillometry (IOS) is also performed, with results reported as R5, R20, R5-R20, X5, Fres, and Ax.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC \< 70%)
* Aged 40-80 years
* Smoking 10 pack-years or more
* Postbronchodilator FEV1 \< 80%

Exclusion Criteria:

* History of COPD exacerbation within 3 months
* Asthma, bronchiectasis, pulmonary fibrosis
* Inability to perform spirometry, impulse oscillometry, or 6-minute walk test
* Pregnant or breastfeeding women
Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS

Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old at the start of Screening Visit
* A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
* Subjects must have had back pain for at least 12 months before Screening
* No sacroiliitis defined by Modified New York (mNY) criteria on sacroiliac (SI) x-rays
* Active disease at Screening as defined by

  * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4
  * Spinal pain \>= 4 on a 0 to 10 Numerical Rating Scale (NRS)
* Inadequate response to, have a contraindication to, or have been intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria:

* Diagnosis of AS or any other Inflammatory Arthritis
* Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
* Exposure to more than 1 tumor necrosis factor (TNF)-antagonist or primary failure to TNF antagonist therapy
* History of or current chronic or recurrent infections
* Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent Tuberculosis (LTB)
* Recent live vaccination
* Concurrent malignancy or a history of malignancy
* Class III or IV congestive heart failure - New York Heart Association (NYHA)
* Demyelinating disease of the central nervous system
* Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
* Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study
A Single-Group Clinical Trial Investigating the Effects of a Hair Vitamin Combination on Hair Growth and Hair Health

This clinical trial aims to investigate the effectiveness of two Vitamins Revive hair supplements in promoting hair growth, reducing hair loss, and improving overall hair health. The products under assessment are Hair Nutra Growth and Hair Nutra Boost. The trial will assess the efficacy of the products to induce better hair growth, reduction in hair loss and shedding, increased hair thickness and fullness, and improvement in hair appearance and vitality over a 12-week testing period. Participants will complete study-specific questionnaires at Baseline, Week 4, Week 8, and Week 12. Participants will also provide photos of their hair at Baseline, Week 4, Week 8, and Week 12.


Eligibility Criteria:
Inclusion Criteria:

* Women Aged 30+ Self-reported issues with hair growth, shedding, and thinning Generally healthy - don't live with any uncontrolled chronic disease Must be willing to stop taking any other hair growth supplements or biotin supplements for the duration of the trial In the last three months, has not introduced any new supplements or medications to target hair growth, hair loss, or hair health Individuals must agree to refrain from dyeing their hair in the target interest areas until the study is complete Willing and able to take high-quality photographs of their hairline

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders Anyone with known severe allergic reactions Anyone with a known allergy to any of the ingredients Anyone currently using a hair growth supplement Anyone currently using biotin Anyone with scalp or hair diseases including but not limited to alopecia areata (a hair loss disorder leading to patchy bald spots on the head) Women who are pregnant, breastfeeding, or attempting to become pregnant Unwilling to follow the study protocol
Effect Of Piperine In Patients With Oropharyngeal Dysphagia

Piperine acts on the oropharyngeal TRPV1, increasing sensory input and the release of substance P. These actions may accelerate the oropharyngeal swallow response, improving the swallowing of dysphagic patients.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* History of swallowing difficulties associated with aging and/or neurological diseases (neurodegenerative or non-progressive neurological diseases)
* Study explained and written subject information given
* Informed consent signed

Exclusion Criteria:

* Patients suffering idiosyncratic phenomena or who are allergic to any medication, especially iodinated contrast media
* Patients suffering major respiratory disease or undergoing any type of surgery in the three months prior to the study
* Patients with a background of alcohol dependence or other drug dependence
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of the study
Prehospital Risk Stratification in Acute Coronary Syndromes

A feasibility study of prehospital echocardiographic examination and point-of-care troponin analysis, conducted by paramedics, in patients with suspected acute coronary syndrome. Echocardiographic images are sent together with information of TnT values and ECG signs to there cardiologist on call, deciding for immediate Cath lab (PCI) evaluation or local hospital evaluation.

Assessing the feasibility and sensitivity and specificity of prehospital risk stratification by echocardiography and Troponin T in patients with suspected acute coronary syndrome, compared with conventional in-hospital evaluation.

The trial will be conducted at Sørlandet Hospital, Norway. One acute care ambulance in Agder county will be equipped with a high-end cardiac ultrasound scanner with wireless communication to the cardiac centre/cardiologist, and a point-of-care troponin T quantitative analysis kit Paramedics will be offered a comprehensive hands-on course in cardiac ultrasound image acquisition by an echo-technician and a cardiologist. Similar, a short course will be given in point-of-care troponin analysis.

Imaging quality Communication between paramedic and cardiologist established Image transfer and interpretation by cardiologist functional Technical problems addressed and solved in collaboration with manufacturer

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the medical dispatch center (AMK) with chest pain; Norwegian medical index criteria A10.2- A10.11
* Men and women
* Age ≥ 18
* Informed consent for participation
* Examined by paramedics in a prehospital setting due to newly onset (\<12 hours) chest pain (lasting for \>20 min) and suspected AMI

Exclusion Criteria:

* Any condition which interfere with the ability to cooperate
* Hemodynamic instability
* Severe mental disorder
* Pregnancy or breast-feeding
* STEMI
* Obvious non-cardiac origin of the chest pain
Medical Treatment of "High-Risk" Neurofibromas

Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called plexiform neurofibromas. These tumors can be defined as "high-risk" when they result in severe pain, physical disability, organ dysfunction and/or become life-threatening. Presently, there is no effective medical therapy to offer patients with "high-risk" plexiform neurofibromas, and surgery does not provide lasting help. This study will evaluate the effectiveness of two treatment combinations in patients with "high-risk" plexiform neurofibromas.

The study's design involves treating eligible patients with a combination of celecoxib and pegylated interferon alpha-2b. If the patients have at least a partial response after six months, they may continue on the same treatment for up to two years. If the patient experiences less than a partial response, or has progressive disease after six months of therapy, then vincristine and temozolomide will be added to the celecoxib and interferon alpha-2b backbone. Response to treatment will be assessed after a minimum of six months, presuming the patient has not experienced progressive disease. Total duration of therapy on study is two years for any individual treatment plan.

Eligibility Criteria:
Inclusion Criteria:

* "High-Risk" Plexiform Neurofibromas associated with a diagnosis of NF1
* 2-30 years old (minimum bodyweight of 10 kilograms)
* Adequate renal function

Exclusion Criteria:

* Previously untreated active optic glioma
* History of any previous allergy to study medications
* History of ischemic vascular disease
* Pregnancy / Breast feeding
Characteristics of Hypophosphatasia in Adult Patients in Rheumatology and Their Value in Developing an Algorithm to HPP-diagnosis - the COHIR Multi-center Study

Non-interventional, prospective, multi-center investigation with exploratory data analysis to assess the proportion of patients with hypophosphatasia presenting at departments of rheumatology and to establish an algorithm to HPP diagnosis

Acronym: Expansion:

HPP =Hypophosphatasia COHIR ="Characteristics of Hypophosphatasia in Adult Patients in Rheumatology" ALPL =Alkaline Phosphatase

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Clinical suspicion of hypophosphatasia
* Evidence of an abnormal ALP (ALP below LLN) within the clinical routine screening

Exclusion Criteria:

* Failure to meet the inclusion criteria listed above
NSAIDs With Morphine-PCA Compared to Epidural Analgesia in Thoracotomy Pain

The investigators investigated whether a strictly controlled pain management with patients participating in a clinical study can attenuate persistence of post-thoracotomy pain. The investigators also wanted to find out whether NSAID + intravenous patient-controlled analgesia with morphine is an efficacious alternative to thoracic epidural analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective thoracotomy for lung surgery

Exclusion Criteria:

* Contraindication to any of the study drugs or an epidural catheter,
* Significant liver, renal or cardiac disease
* Peptic ulcer
* Regular use of analgesics
* Re-thoracotomy, and the patient´s inability to understand the use of PCA/patient controlled thoracic epidural analgesia (PCEA).
High-flow Nasal Oxygen in Palliative Care: Pilot Study

In palliative care, the relief of the dyspnea is necessary. Medications for the reduction of dyspnea have side effects. High-flow nasal cannula oxygen therapy (HFNC) is a new way to deliver oxygen. Investigators hypothesize that HNFC is an acceptable technic for the patient with dyspnea in palliative care.

A pilot study with 30 patients will be conducted. Acceptability of HNFC will be studied by the time of use by patients of the HNFC during one week. The effectiveness of HNFC in relieving dyspnea will be studied using Borg scale.

Pilot study for acceptability of high flow nasal cannula oxygen therapy in palliative care Population: 30 patients in palliative care (for lung cancer, terminal respiratory failure) who suffer from dyspnea and have oxygen therapy. Patients with curative care are excluded and patients who require non invasive ventilation.

An oral consent is asked.

Primary objective: acceptability of HNFC in patients with dyspnea in palliative care during one week

Secondary objectives:

* Tolerance of HNFC at short term (1h and 24h) and long term (7 days) after initiation of HNFC
* Efficiency of HNFC at short term

Primary outcome: duration of use of the HNFC during 7 days

Secondary outcome:

* Tolerance: noise of the system of HNFC, side effects of high flow (nasal dryness..)
* Efficiency: evaluation of dyspnea by Borg scale and measure of respiratory rate and saturation of oxygen one hour after initiation of HNFC

Eligibility Criteria:
Inclusion Criteria:

* Patient followed for respiratory failure with palliative care and :
* More than 18 years old
* Dyspnea related to a respiratory disease
* Hypoxemia requiring the introduction of more than 4 liters of oxygen for a sp02 \> 90%
* Patient affiliated to a social security system

Exclusion Criteria:

* Patient less than 18 years old
* Patient with guardianship, trusteeship
* No consent for participation at the study
* Project of curative care
Effect of a Novel Melatonin Supplement on Sleep Quality

Melatonin is a hormone naturally found in our body that increases in our blood at night and controls how we sleep. Melatonin can also be taken as a pill and numerous clinical trials have documented improved sleep quality following melatonin supplementation before bed. However, it is not known whether such supplements actually increase blood melatonin above normal levels, particularly at night.

The aims of this study are to investigate whether a novel melatonin supplement (Ritual Sleep BioSeriesTM Melatonin) can increase blood melatonin in human participants at night, and to determine if taking the supplement before bed for two-weeks can improve sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Aged 18-40
* Sometimes have trouble sleeping (Pittsburgh sleep quality index score \>5)

Exclusion Criteria:

* Routinely taking melatonin supplements or other drugs known to affect sleep
* A diagnosed sleep disorder
* Major psychiatric illness
* Current physical injury
* Known or suspected hypersensitivity to melatonin
* Presence of major sleep disruptors at home (e.g. new born baby)
* Night shift/rotational-shift work
* Receiving non-pharmacological treatment for sleep disorder (e.g. cognitive behavioral therapy)
* Substance use disorder
* Recent (\<1 month) increase in daily caffeinated drink consumption
* Consuming \>14 standard alcoholic drinks per week
* Pregnant or lactating
CT Screening For Lung Cancer in High Risk Patients: the Russian Study.

This prospective cohort trial was planned to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking.

Low dose computer tomography (LDCT) showed promising results in recently published studied. Lung cancer screening programs with fluorography introduced in USSR in 70s-80s showed shift to earlier stages with no data on mortality. No other studies or programs on lung cancer screening were introduced in Russia since then.

The purpose of this study is to assess the feasibility of establishing a lung cancer screening program in Russian Federation using LDCT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. This cohort prospective study is planned to enroll at least 500 current or former smokers.

Patients will be screened by LDCT scan at baseline with recommendation to perform follow-up in case of any positive result. For nodes more than 10 mm full clinical examination is recommended. For nodes 3-9.9 mm follow-up scans in 1, 3 or 6 months is recommended. For nodes smaller than 3 mm and negative results annual LDCT is recommended. Patient with positive results will be followed until final clinical diagnosis.

Secondary outcomes include:

* Lung cancer diagnoses
* Lung cancer and overall mortality
* Quality of life assessment
* Complications of diagnostic and surgical procedures following a positive result.
* Comparison of independent radiological evaluation of scans.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years
* 30 or more pack-years of cigarette smoking history
* Former smokers: quit smoking within the previous 10 years
* Ability to tolerate CT procedure
* Signed informed consent

Exclusion Criteria:

* Any cancer other than nonmelanoma skin cancer or carcinoma in situ in the 5 years prior to eligibility assessment
* Severe uncontrolled heart, vascular, respiratory or endocrine pathology.
* Life-expectancy less than 1 year
* History of lung cancer
* History of lung surgery.
* Acute respiratory disease
* Hemoptysis.
* Weight loss more than 10 kg in the 12 months prior to eligibility assessment
* Participation in other cancer clinical trial
* Chest CT examination in the 12 months prior to eligibility assessment.
A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate

This study evaluated the safety and efficacy of SM03 compared to placebo in patients with active rheumatoid arthritis(RA) receiving methotrexate


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-75 years of age.
* Rheumatoid arthritis (RA) for ≥ 12 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
* Moderate to severe active RA with swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
* At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes
* Inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks.

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA.
* Use of any biological DMARDs for RA within past 6 months.
* Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
* Active infection, or history of serious or chronic infection
An Exploratory Investigation of a Supplement to Support Student Learning

In this trial, the herbal supplement (GeniusDrops) will be tested to see the effects it has on the dependent variables of interest. Participants will take the supplement twice a day for a month and respond to surveys at study baseline, midpoint, and the conclusion of the study. The findings of this study will be used for marketing materials and to inform future trials using the supplement.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form and a parental assent form
* Must be experiencing issues with focus, mood, and memory
* Must be looking to improve classroom performance
* Gets easily distracted

Exclusion Criteria:

* Diagnosis of ADD or ADHD
* Currently taking a prescription medication meant to treat ADD or ADHD
* Diagnosed with additional conditions that would not allow them to adhere to the protocol.
* Willing to take a supplement targeting improving mood, concentration, and focus