cyrilzakka/clinical-trials huggingface dataset:
Reliability of Function Tests for People With Back Pain.

Back pain is often accompanied by changes in function. The performance of individuals with their backs on their wills may become more functional. It is believed that the test will present good to excellent reliability in individuals with chronic back pain. From this, it can be used in the clinic to verify the functional capacity of these individuals.

This study will be performed to verify the reliability of the functional tests for individuals with back pain. A study in which individuals with back pain will be assessed on the first day and after the interval of seven days. They should perform the 6-minute walk test and answer some questionnaires such as the Roland Morris - disability questionnaire, the IPAQ - physical activity level questionnaire and Numeric Rating Scale, after the tests will be performed Timed 10-Meter Walk Test and 30 Second Sit to Stand Test. To avoid a random error, a minimum sample size of 30 participants is required. For statistical analysis, Shapiro-Wilk test will be used for data normalization and the reliability between measurements will be calculated through do Intraclass Correlation Coefficients, standard error of measurement and Minimal Detectable Change. There were no studies in the literature and recorded in the Clinical Trials that evaluated the reliability of these tests for individuals with chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes aged 20 to 65 years and low back pain for more than 3 months.

Exclusion Criteria:

* Acute pain of back pain that disables the performance of the tests.
* Pregnancy.
* Neoplasms.
* Known heart, lung or metabolic diseases.
* Hypotension (BP \< 90 x 60 mmHg) or stage II hypertension (BP \> 140 x 90 mmHg), medicated or not.
* Fall or faint in the previous two months.
* Have not undergone any spinal surgery.
* Have not had neuromuscular impairment in the last three months and who need help to follow the instructions.
Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity

Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC) ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans.

Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans compared to mannitol and to each other.

Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving acetazolamide and 17 patients receiving NAC. Patients' kidney function was monitored using serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed using RIFLE criteria. Patients' liver function tests and hematological parameters were also monitored.


Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients to receive cisplatin based chemotherapy protocol.
2. Adult patients from 18 to 65 years.

Exclusion Criteria:

1. Existing renal impairment ( Creatinine clearance \<30 ml/minute)
2. Severe hepatic impairment (Child Pugh score C).
3. Hypersensitivity to sulfonamides.
4. Patients with chronic non-congestive angle closure glaucoma.
5. Hypersensitivity to sulphur compounds, N-acetylcysteine or any component of the formulation.
Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees

In this study we want to compare Narrative Exposure Therapy to Treatment as Usual for traumatized refugees and asylum seekers in the Mid- Norway region. Clinicians in psychiatric outpatient clinics will deliver the two conditions to asylum seekers and refugees that qualifies for Posttraumatic Stress Disorder. We will investigate if refugees and asylum seekers will improve more with Narrative Exposure Therapy or Treatment as Usual, and if there will be any differences between improvement for asylum seekers compared to improvement for refugees with residential status.

Narrative Exposure Therapy (NET) will in a randomized controlled trial be compared to Treatment as Usual(TAU) for traumatized refugees and asylum seekers in the Mid- Norway region. Clinicians in psychiatric outpatient clinics in the region will deliver the two conditions to asylum seekers and refugees that qualifies for Posttraumatic Stress Disorder. Each patient will receive 10 sessions of either NET or TAU. Assessment tools in the study will be MINI International Neuropsychiatric Interview, Clinician Administered PTSD Scale and the Hamilton Rating Scale for Depression. Exclusion criteria will be psychosis, substance abuse and serious suicidal ideations. The age group in focus will be adults of 18 years or more. Refugees and asylum seekers from all countries will be accepted in the study, and there will be used qualified interpreters if the refugees do not speak English or Norwegian fluently.

Eligibility Criteria:
Inclusion Criteria:

* Refugee or asylum seeker
* Posttraumatic Stress Disorder diagnosis according to the DSM-IV criteria

Exclusion Criteria:

* Psychosis
* Substance abuse
* Serious suicidal ideations
Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients with Chronic Kidney Disease (CKD)

The purpose of this treatment protocol is to treat an intermediate-sized population with chronic kidney disease (CKD). Protocol includes a single treatment with intravenously-delivered allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) infusion. Individuals will have subsequent follow up for safety evaluations.


Eligibility Criteria:
Inclusion Criteria

* Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m\^2
* Hemoglobin A1c of ≤9%, if diabetes mellitus present
* Ability to give informed consent

Exclusion Criteria

* Anemia (hemoglobin \<8.5 g/dL)
* Body weight \>150 kg or BMI \>50
* Uncontrolled hypertension: sustained systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg despite maximal doses of at least 2 different classes of anti-hypertensive medications
* Chronic hypotension history: sustained SBP \<85 mmHg
* Kidney failure requiring ongoing kidney replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
* Active immunosuppression therapy (including prednisone ≥10 mg daily)
* Kidney transplantation history
* Solid organ transplantation history
* Recent cardiovascular event (hospitalization for myocardial infarction, stroke, congestive heart failure (NYHA class ≥III or ejection fraction ≤30%) within 3 months or uncontrolled cardiac arrhythmias (e.g. ventricular arrhythmia, supraventricular tachycardia and bradyarrhythmia)
* History of liver cirrhosis
* Chronic obstructive pulmonary disease or asthma requiring daily medication
* History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
* Pregnancy
* Unwilling to use contraception for at least 2 months after MSC infusion if sexually active and able to become pregnant or father a child.
* Active malignancy
* Active infection (e.g. systemic or specific organ involvement such as pneumonia or osteomyelitis)
* Recent COVID-19 infection within the last 1 month
* History of hepatitis B or C (without cure), or HIV infection
* History of allergic reaction to cellular products (i.e. blood transfusions, platelets)
* Active tobacco use
* Illicit drug use and excessive alcohol use
* Presence of psychosocial issues (e.g., uncontrolled mental illness, unpredictable childcare or eldercare responsibilities, irregular/ inflexible work schedule) that may interfere with the ability to complete all study procedures
* Patients anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.
* Inability to give informed consent
Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

The primary purpose of the present study is to investigate the usefulness of Procalcitonin as a supplement to the Streptococcal antigen test and Centor criteria in the differential diagnose making between Streptococcal and non-Streptococcal acute tonsillitis.

Furthermore, the investigators aim to examine Procalcitonin as a diagnostic marker in acute tonsillitis due to Fusobacterium Necrophorum.

Acute tonsillitis is based on typical symptoms (sore throat, pain on swallowing, and fever) and clinical findings of tonsillar exudate and hyperemia.

10-20% of patients seen by their family physician, have acute tonsillitis due to streptococci group A. In Denmark, Centors criteria and the Streptococcal antigen test (Strep. A-test) are gold standard in the diagnostic process of streptococcal acute tonsillitis. Although the sensitivity and specificity of the Strep. A-test is biochemically high, its clinical reliability is reduced due to several influential factors. Moreover, studies suggest that 4-10% of patients are tested false-negative based on clinical criteria and the Strep A-test.

Fusobacterium necrophorum are suspected to be the cause of acute tonsillitis in teenagers and young adults (5-15%). However, there is no rapid test available for this bacterium. Since tonsillar surface swab is not included in the diagnostic standard, family physicians get no information about infection due to Fusobacterium necrophorum or other pathogens.

C-reactive protein, leukocyte count and absolute neutrophil count as diagnostic markers are examined with variable results. Procalcitonin is a relatively new marker of bacterial infection, which has the advantage of more rapid and specific induction compared to the other markers.

Eligibility Criteria:
Patients with acute tonsillitis:

Inclusion Criteria:

* Age between 15 and 40 years.
* Subjective and objective signs of Acute Tonsillitis + presents of 2-4 Centor Criteria.
* participation accept after verbal and written information.

Exclusion Criteria:

* Antibiotic treatment within the last month.
* Other infection within the last month.
* Inadequate tonsil swabs due to lack of cooperation.
* Suspicion of peritonsillar abscess

Control patients:

Inclusion criteria:

* Age between 15 and 40 years.
* Participation accept after verbal and written information.

Exclusion Criteria:

* Antibiotic treatment within the last month.
* Infection within the last month.
* Tonsillectomy
* More than 2 cases of acute tonsillitis within the last 12 months.
A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample.
3. Participants must have advanced GIST and radiologic progression on imatinib treatment.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
5. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug.
6. Participants of reproductive potential must agree to follow contraception requirements.
7. Participants must have at least 1 measurable lesion according to mRECIST v1.1 within 21 days prior to the first dose of study drug.
8. Adequate organ function and bone marrow reserve based on laboratory assessments performed at screening.

Exclusion Criteria:

1. History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample.
2. Has known active central nervous system metastases.
3. New York Heart Association Class II-IV heart disease, myocardial infarction within 6 months of Cycle 1 Day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure.
4. Use of strong or moderate inhibitors or inducers of cytochrome P450 (CYP) 3A prior to the first dose of study drug, and consumption of grapefruit or grapefruit juice within 14 days prior to the first dose of study drug.
5. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
6. Known human immunodeficiency virus or hepatitis C infection only if the participant is taking medications that are excluded per protocol, acute or chronic hepatitis B, or acute or chronic hepatitis C infection.
7. Gastrointestinal abnormalities including, but not limited to:

   1. inability to take oral medication
   2. malabsorption syndromes
   3. requirement for intravenous alimentation
8. Any active bleeding excluding hemorrhoidal or gum bleeding.
Nitrate-based Nutritional Formula for Oxygen Saturation and Patient-reported Outcomes in Covid-19

A preliminary open-label case report demonstrated the beneficial effects of an innovative nitrate-based nutritional formula on oxygen saturation in patients with COVID-19. Whether these initial findings are relevant in a more robust research design currently remains unknown. Therefore, the main objective of this randomized controlled trial was to analyze the acute effects of nitrate-based nutritional formula on peripheral SpO2, patient-reported outcomes, and safety indices in patients with acute COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

* age 3 18 years
* confirmed SARS-CoV-2 infection
* SpO2 \< 95%
* COVID-19 patients in stable condition (i.e., not requiring hospital admission)

Exclusion Criteria:

* regnant or lactating women
* concomitant pulmonary and cardiovascular conditions
* history of dietary supplement use during the past four weeks
* participation in another COVID-19-related study
* unwillingness to give informed consent
Effects of Quinoa Consumption on Markers of Cardiovascular Risk and Gastrointestinal Health

Quinoa is possible alternative to wheat, corn and rice due to its high nutritional value and possible properties against cardiovascular diseases and for improving gut health. There are some animal studies to suggest that some important class of compounds like fibre, antioxidants and protein, found naturally in quinoa, have beneficial effects against markers of cardiovascular diseases. However, the effects of quinoa on humans has rarely been investigated. This study will investigate the effects of daily consumption of quinoa for four weeks on markers of cardiovascular risk, including blood cholesterol and resting blood pressure, and on gut health in a randomised cross-over study design.

Quinoa is a possible alternative to wheat, corn and rice due to its high nutritional value and possible properties against cardiovascular diseases. There are some animal studies which suggest that quinoa has beneficial effects against markers of cardiovascular diseases, particularly blood lipid profile. The grain has a unique nutritional profile, with high fibre levels and a wide range of phytochemicals which may influence gut bacteria and improve gastrointestinal health.

However, the effects of quinoa on humans has rarely been investigated with just two small interventions published. These studies also showed an improvement in blood lipid profile after consuming quinoa daily. There have been no studies which have investigated the effects of quinoa on gut bacteria and gastrointestinal health. Therefore, this human dietary intervention study aims to determine the effects of quinoa consumption on markers of cardiovascular diseases, the gut microbiome and gastrointestinal health.

The study is a randomized cross-over designed dietary intervention study with 4-week study periods separated by a 4-week wash-out period. The treatment will be the daily consumption of a test bread roll containing quinoa to deliver 20g quinoa per day (one roll per day). The control will be the same amount of a refined wheat roll. Markers of cardiovascular disease risk, including fasting blood lipid profile, plasma glucose and insulin concentration, resting blood pressure will be compared at the beginning and end of each treatment period. Changes in the numbers and species of gut bacteria, and products of bacterial fermentation will be made in stool samples collected at the beginning and end of each intervention period as indicators of gastrointestinal health.

Eligibility Criteria:
Inclusion Criteria:

1. healthy men \>35 years old
2. body mass index \>25 kg/m2
3. Non-smokers with no known previous history of cardiovascular disease or type 2 diabetes
4. Not receiving any current medication. Supplement users will be included but will be asked to stop taking supplements for the duration of the study

Exclusion Criteria:

1. Age ≤ 35 or BMI ≤25
2. Smokers
3. Individuals with known or suspected allergy to wheat
4. Individuals with known history of cardiovascular diseases or type 2 diabetes
5. Individuals with recent weight loss (\>10%) or planning to lose weight during the study
Nitrous Oxide On Acute Postoperative Pain and Opioid Consumption and Chronic Pain After Inguinal Hernia Repair Surgery

To compare postoperative pain, opioid consumption and chronic pain in patients undergoing to hernia repair surgery after receiving nitrous oxide or oxygen during the general anesthesia.

The study is prospective and double blind. In the clinic, patients undergoing inguinal hernia surgery that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups. In the first group of patients will receive Nitrous Oxide and In the second group of patients will receive oxygen during the general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old at time of the first procedure
* American Society of Anesthesiologists physical status I or II
* Inguinal hernia repair surgery undergoing the general anesthesia

Exclusion Criteria:

* Neuropathic disease
* Chronic opioid users
* Contraindication for Nitrous Oxide receive
* Consent will not be obtained patient
* Psychiatric disorders
* Current or recent drug abuse (within past 6 months).
Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms

It is well proven that the intestinal microbe regulates bone metabolism by the absorption of calcium and other metallic trace elements. Studies also show that regulation of the intestine and its microbe can affect bone density and resistance to a variety of animal models and humans. At the same time, interest in polyphenol-intestinal microbial interactions and in particular flavonoids and catechins has increased. Indeed, it has been observed that they are transformed via the microbe into bioactive compounds, and polyphenols themselves can modify the synthesis of the intestinal microbe.

OSTEOME aspires to design and develop a novel dietary supplement for osteoporosis, activating the intestinal microbiome. At the same time companion biomarkers will be studied related to the efficacy and tolerability of the new supplement. The selection of flavonoids will take place through in vitro and in silico studies focusing on their interaction with pathways that regulate the activity of osteoclasts and osteoblasts. The efficacy and tolerability of the dietary supplement will be evaluated through a randomized clinical intervention.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* T-score in the osteopenic range (-1.0 \> T-score \> -2.5) at either the lumbar spine (LS) or femur as measured by dual energy X-ray absorptiometry (DXA)

Exclusion Criteria:

* T-score in the osteoporotic range (T-score \< -2.5) at any site
* Patients receiving supplements of calcium and/or vitamin D at that time or during the last 6 months
* Patients receiving medications known to positively or negatively affect bone turnover or BMD at that time or during the last 3 years (e.g. antiresorptive agents, oestrogens, systemic corticosteroids), or
* Secondary cause of osteoporosis (e.g. alcohol abuse, thyrotoxicosis etc)
* Patients who did not attend to their follow-up appointment and consequently had only the baseline measurements
Complete Denture Tooth Movement in Digital Light Processing Versus Conventional Fabrication Techniques

The purposes of this study are to compare the denture tooth movement, the amount of occlusal adjustment needed and the chairside time required for CAD-CAM and conventional dentures.

PICOT Format:

P: completely edentulous patients. I: Complete denture fabricated by digital light processing method. C: Complete denture fabricated by the conventional method.

O:

Primary Outcome: Denture tooth movement

Secondary outcomes:

* Amount of occlusal adjustments needed
* Chairside time T: Three months with a wash-up period of 2 weeks


Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 40-70 years.
* Cooperative patients with no history of psychological diseases.
* Completely edentulous patients with types I, II and III mandibles according to McGarry et al.

Exclusion Criteria:

* Pathological changes of residual ridges
* Patients with xerostomia.
* Patients with flabby ridges.
* Temporomandibular disorders and neuromuscular disorders e.g. Parkinson's disease
cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose

The purpose of this study is to determine the normal distribution of nasal tissue cathelicidin antimicrobial peptides (cAMP) levels in subjects with normal smell and subjects with smell dysfunction. The investigators will also look at the effect of nasal saline irrigation on olfaction and cAMP levels and if nasal irrigation is capable of harvesting olfactory cilia. The investigators hypothesize that nasal saline will have no effect on olfaction and will be inadequate to harvest olfactory cilia.

The investigators will recruit 40 subjects: 10 with olfactory dysfunction and 30 with normal olfaction. The normal olfaction group will be randomized (15-15)to either daily saline nasal irrigation for one week or no irrigation. Normal olfaction subjects will be seen for two visits, olfactory dysfunction for one. All subjects will complete an UPSIT (smell identification test)and a co-morbidity form. All subjects will have a brief nasal exam and then have nasal cells collected by means of a curette on one side and a cytobrush on the other. All subjects will receive Afrin and lidocaine, to improve visualization and for comfort during cell collection. Subjects will then complete a Comfort Scale related to the methods of cell collection. Normal olfaction subjects randomized to nasal irrigation will receive instructions on how to do it and the irrigation results will be collected for analysis along with the nasal cells. At their return visit, normal olfaction subjects will repeat the UPSIT and the comfort scale--all normal olfaction subjects will have a repeat cell collection. Subjects randomized to nasal irrigation will also complete a transition scale which asks if they feel the irrigation made a difference in their sense of smell. Subjects are compensated for time with a gift card.

Eligibility Criteria:
Inclusion Criteria:

Normal olfactory function cohort:

* self-reported normal smell function
* age greater than 18 years

Olfactory dysfunction cohort:

* ICD9 diagnostic code for olfactory dysfunction
* idiopathic olfactory dysfunction
* age greater than 18 years

Exclusion Criteria:

* allergy to lidocaine
* active upper respiratory infection
* previous nasal or sinus surgery
* current tobacco use
* unable to give consent due to language barrier, cognitive or medical issues