cyrilzakka/clinical-trials huggingface dataset:
Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily.

Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.

Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosis previously for 6 months
* Past asthma medication without change for previous 6 months
* Increased NO levels and ability to perform maneuver
* ICF signed by parents

Exclusion Criteria:

* Systemic steroids in past 60 days,inhaled/nebulized steroids in past 4 weeks
* Hospitalization within 3 months
* Upper or lower airways active infection or cigarette smoke direct exposure
* Use of other asthma medications other than bronchodilators one month prior and during the trial
* Noncompliance
A Biobehavioral Intervention for Young Men With Testicular Cancer

This study is a randomized controlled biobehavioral pilot trial designed to investigate the feasibility and preliminary efficacy of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients.

Participants will be randomized to receive six sessions of GET or Individual Supportive Therapy (ISP) delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1) and twelve weeks after intervention at T2. Additionally, identified biomarkers will be measured at baseline and at T2.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18 and 39 years at the time of consent
* confirmed diagnosis of testis cancer (any stage)
* completed chemotherapy for testis cancer within 2 years prior to consent
* fluency in English (per self-report)
* sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale or a score of 4 or greater on the Distress Thermometer (DT)

Exclusion Criteria:

* lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (per self-report)
* active suicide plan
* disorder that compromises comprehension of assessments or informed consent information
* self-reported medical condition or medication use known to confound measures of systemic inflammation
* daily smoking
Influence of the Noradrenergic System on the Formation of Intrusive Memories

Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether the activity of the noradrenergic system during an intrusion-inducing stressor influences subsequent intrusive memories.

The investigators conducted an experimental, double-blind, placebo-controlled study in 118 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg yohimbine, stimulating noradrenergic activity, or 0.15 mg clonidine, inhibiting noradrenergic activity, or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following four days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.

Eligibility Criteria:
Inclusion Criteria:

* healthy participants
* German on a native level

Exclusion Criteria:

* former or present DSM IV Axis I disorders
* physical illnesses
* any medication intake (except oral contraceptive)
* history of sexual abuse or rape
* pregnancy or lactation period
Haemodynamic Feasibility Study of Sensors Within a Tilting Table Examination

This study´s aim is to explore physiological associations concerning pulse wave velocity, heart rate and blood pressure in order to make taking the blood pressure more comfortable.


Eligibility Criteria:
Inclusion Criteria:

* patients with syncope and planned tilting table investigation
* male and female patients aged at least 18 years
* persons being able to understand and to follow the study stuff´s instructions

Exclusion Criteria:

* pregnancy or breast feeding
* patients not being able to consent
* cardiac pacemaker / defibrillator
* illness of skin
Physical Work Capacity After Traumatic Brain Injury

The purpose of this study is to determine whether body weight supported treadmill training is more effective than traditional physical therapy at restoring gait in persons recovering from traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* traumatic brain injury
* follow two step commands
* between 18 and 60 years old
* between 3 and 36 months post injury

Exclusion Criteria:

* known cardiovascular disease
* uncooperative, behavioral challenges
Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma

This is a prospective study evaluating the effect of expression of CD74 and VEGF on outcome of treatment in patients with malignant pleural mesothelioma receiving Pemetrexed/Platinum protocol. The paraffin blocks of the patients will be tested for CD74 and VEGF before starting treatment using IHC and the results will be correlated with the outcome of treatment during evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic or cytologic diagnosis of malignant pleural Mesothelioma
2. No prior chemotherapy.
3. ECOG less than or equal to 2 .
4. Measurable disease according to the requirements of SWOG criteria.
5. Age ≥ 19 years .
6. Estimated life expectancy of at least 12 weeks .
7. Adequate bone marrow reserve (white blood cells \[WBC\] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).

Exclusion Criteria:

1. Presence of central nervous system metastases.
2. Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[UNL\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
3. Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50mL/min).
4. Serious concomitant systemic disorder incompatible with the study.
5. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
6. Pregnancy
A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

- As specified in protocol

Exclusion Criteria:

- As specified in protocol
Risk Clinical Stratification of Sickle Cell Disease in Nigeria, Assessment of Efficacy/Safety of Hydroxyurea Treatment

The vast majority of births with sickle cell disease (SCD) occur in Africa and 90% are thought to die before the age of five. Hydroxyurea (HU) is the only drug approved by the FDA for the treatment of sickle cell anemia. Although HU is used to treat small numbers of patients in Africa, cost, fear of toxicity, and lack of awareness and availability limit its use. The leukopenia that may be seen with HU raises the possibility of increased susceptibility to infection. Risk stratification - i.e., identification of patients most likely to benefit- could focus therapy and provide confidence that the risk:benefit ratio is favorable. Several clinical measures of future risk are well defined and findings on modifier genes in the US, primarily related to fetal hemoglobin (HbF), have further improved risk prediction. Whether the genetic variants predict severity in Africa is not known. The investigators have established a SCD cohort in Ibadan, Nigeria. In the first phase of this research the investigators will implement clinical risk examinations and assess the relationship between clinical characteristics (including levels of HbF) and known genetic markers. As a proxy for a birth cohort, the investigators will compare the frequency of the genetic markers in adult patients (i.e., "survivors") to children. In the second phase the investigators will randomize 40 high risk adult patients to fixed low dose HU or no HU treatment in a crossover design and monitor hematologic and physiologic parameters to document hematologic effects and safety. This work will lay the basis for a large-scale trial to document safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* HemoglobinSS (HbSS) or beta-zero (B0) thalassemia genotype
* Hemoglobin concentration \>4.5 g/dL at steady state and time of enrollment
* Absolute neutrophil count \>1,500/mircoliter
* Platelet count \>95,000/microliter
* Serum creatinine \<1.2 mg/dL
* Alanine transaminase less than two times the upper limit of normal

Exclusion Criteria:

* HIVpositive
* Hepatitis B and/or C positive
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.

This study consists of the following phases: screening phase; double-blind treatment phase; safety follow-up phase. Safety is monitored throughout the study.

Eligibility Criteria:
Principal inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male or female aged 18-64 years (inclusive).
* Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.
* Body mass index (BMI): 18.5 ≤ BMI (kg/m2) \< 32.0.
* Insomnia disorder according to DSM-5 criteria.
* Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
* Insomnia Severity Index score ≥ 15.

Principal exclusion Criteria:

* Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
* Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
* Caffeine consumption ≥ 600 mg per day.
* Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
* Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel \> or= 3 time zones during study.
* Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
* AST and/or ALT \> 2 × ULN and/or direct bilirubin \> 1.5 × ULN (except known history of Gilbert's syndrome).
* Severe renal impairment (known or defined as estimated creatinine clearance \< 30 mL/min).
* History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.

This was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest.

The date of first ofatumumab prescription claim or other DMT of interest was defined as the index date. No post-index requirements were imposed.

Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient clinical characteristics.

The initial data were extracted in October 2020. The data and results were refreshed in April 2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ≥ 1 prescription for ofatumumab in the LRx/Dx database were included. The date of the first observed prescription within the index window served as the index date.

  -. Patients with a diagnosis of COVID-19 or a COVID-19 vaccination any time during the study period.
* Patients with linkage to the Dx database.

Exclusion criteria

- No exclusion criteria were applied to patients in the study.
Gallium-68 DOTATOC for Management of Neuroendocrine Tumors

Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. This study is designed to evaluate the clinical impact of PET CT scanning using this agent in the evaluation and management of patients with NETs.

Patients with NETs will be evaluated by their own physicians. Before doing the PET scan using Gallium-68 DOTATOC, the physicians will be asked to describe the type of treatment that they would recommend. After the test is performed and the result reviewed, the physician will be asked to reevaluate the therapeutic and management options. Data will be analyzed to determine the impact of the testing on patient management.

Gallium-68 has been designated an "orphan drug" due to the relative rarity of NETs. It is expected that the data collected from this and other similar trials will be used to provide data to the FDA regarding the safety and efficacy of this drug as an imaging agent for NETs and ultimately lead to FDA approval.

Eligibility Criteria:
Inclusion Criteria:

* Proven or suspected neuroendocrine tumor Physician referral for imaging

Exclusion Criteria:

* Pregnancy
Prevention of Cancer Development and Progression

The purpose of this study is to evaluate the efficacy and safety of arginine in preventing cancer development

Cancer is considered to be the leading cause of death among non-infectious diseases and the most important obstacle to increase life expectancy for every country in the 21st century. However, even if various interventions such as embolization chemotherapy, systemic chemotherapy, radiofrequency ablation, and targeted therapy are widely used in clinical practice, the improvement of patients' survival is still limited. Our previous study found that arginine hydrochloride could significantly promote the apoptosis of liver cancer cells, and inhibit the progression of HCC by prompting the urea cycle. Therefore, our research group has carried out this study to evaluate the efficacy of arginine in preventing cancers.

Eligibility Criteria:
Inclusion Criteria:

* 1. Ages 40-75 years 2. 2 ULN of tumor markers (CEA, AFP, ca-125, ca19-9, NSE, HCG and cyfra21-1) 3. No space-occupying lesions were found by the current imaging examination 4. The major organ function is normal that is meeting the following standards: Blood routine examination: (No blood transfusion, no G-CSF and no medication were corrected within 14 days before screening) a.HB≥80g/L； b.ANC≥1.5×109/L；c.PLT≥50×109/L; Biochemical examination: (ALB was not transfused within 14 days before screening) a. ALB ≥29 g/L； b.ALT and AST\<5ULN；c. TBIL ≤3ULN；d.creatinine ≤1.5ULN( albumin and bilirubin, two indicators of Child-Pugh liver function class, can only have one for 2 points) 5. For women of childbearing age, the results of serum/urine pregnancy tests must be negative within 7 days before initiation of treatment. All men and women who participate in the study have to take reliable contraceptive measures within the trial and eight weeks after the trial is completed 6. volunteers must signed informed consent.

Exclusion Criteria:

* 1. patients suffering from any malignant tumors in the past (within 5 years) or at the same time; excluding cured basal cell carcinoma and carcinoma in situs of cervix 2. Patients who are undergoing transplantation or have a history of organ transplantation 3. Patients with an allergic history of arginine hydrochloride 4. The blood pressure cannot be reduced to the normal range by the antihypertensive drug treatment in patients with hypertension(systolic pressure\>140 mmHg, diastolic pressure\>90 mmHg) 5. Patients with myocardial ischemia or myocardial infarction over grade II or a poorly controlled arrhythmia (including QTc interval: men ≥450 ms; women ≥470 ms) 6.Cardiac functional insufficiency of grade III to IV according to NYHA standard; echocardiography: LVEF\<50% 7. Patients with severe organ damage and less than 3 years expected survival time 8. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives 9. Patients with mental sickness or the history of psychotropic drug abuse 10. Patients with severe infection (unable to control the infection effectively) 11. The researchers believe that any other factors unsuitable for entering into the study.
Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density

The primary purpose of this study is to measure the postoperative changes in bone mineral density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard length Taperloc Complete Reduced Distal stem.

The Taperloc Microplasty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. The primary aim of this study is therefore to compare the postoperative changes in bone density with the Taperloc Microplasty stem, using the standard length Taperloc stem as a control.

In addition, the Taperloc stem has historically had a neck angle of 138°. There have been criticisms that this neck angle is too high for the typical Korean population. The newer Taperloc Complete system (both Microplasty and standard length) has a neck angle of 133°. A secondary aim is Occurrence ratio of thigh pain difference between Microplasty and standard stem in Korean Population

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for primary Total Hip Replacement

Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:

1. Osteoarthritis
2. Avascular necrosis
3. Legg Perthes
4. Rheumatoid Arthritis
5. Diastrophic variant
6. Fused hip
7. Sequelae of Slipped capital epiphysis
8. Traumatic arthritis
9. Patients aged over 20
10. Patients must be able to understand instructions and be willing to return for follow-up

Exclusion Criteria:

* Absolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include:

1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
2. Small Femoral canal

2) Severe osteoporosis (Patients over 65 years old) 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. 8) pregnancy 9) Fracture of the pelvis 10) Subcapital fractures
Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI

Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. However, agitation after anesthesia in children may be difficult to distinguish from pain; accordingly studies are ideally designed during MRI to obviate the contribution of pain during emergence. Airway complications have been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs. Whether the airway complications were due to the LMA or the isoflurane was unclear. Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane compared with IV propofol and 2. airway complications after LMA or nasal prongs.

180 children, ASA physical status 1 or 2 will be recruited for elective MRI scan. Randomized after consent is obtained to one of four groups. Anxiety will be assessed preoperatively using the modified Yale preoperative anxiety scale. Children will be accompanied by one parent to MRI scanner where monitors are applied. All children will have anesthesia induced with nitrous oxide and oxygen followed by sevoflurane until IV is established. Thereupon, they will be managed by their randomization assignment. The propofol pump will be concealed at all times. If propofol was used, it will be disconnected from the patient and residual propofol in the line flushed so prevent unblinding the patient's assignment. A blinded observer will be present to evaluate the patient when emergence begins. The single blinded observer will follow the patient from the MRI scanner through recovery room evaluating vital signs as well as emergence delirium (using the PAED scale). A PAED score \> 12 at any time during emergence period will confirm the diagnosis of emergence delirium. After discharge from hospital, a post-discharge questionnaire will be completed at 12, 24 and 48 hours after discharge. All parents will be called to retrieve the questionnaire results after 48 hours after discharge from hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-12yrs,
* ASA Class I-II,
* Fasting,
* Unmedicated,
* Elective MRI scan

Exclusion Criteria:

* Cognitive impairment,
* On psychotropic medications,
* Taking multiple (\>2) antiepileptic medications,
* Requiring endotracheal intubation for GA