cyrilzakka/clinical-trials huggingface dataset:
Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children

Concussions and headache are a significant problem for children and athletes. While headache generally resolves within 7-10 days; a significant proportion of children, 72-93% experience prolonged headache as a symptom of Post Concussion Syndrome (PCS). The prevailing clinical view is that mild head injuries resolve with little chance of complications. However, the reality is quite different. Concussion in children presents with a range of severity and results in both short and long-term physical, cognitive, emotional and behavioural sequelae known as PCS with varying times to resolution. To date there are no specific treatments for headache pain related to concussion. Physical and cognitive rest is the mainstay of initial concussion management.

The number of children presenting to ED's with a history of concussion and headache is increasing. Presently there are no evidence based guidelines available to guide the medical team to effectively and consistently manage their headache. Our present standard of care is based on the CANCHILD concussion guidelines outlining the child's return to school and activity. Yet, our present standard of treatment is compromised and somewhat counterproductive if we are not treating the child's headache pain.

Our pilot study ' An Open Label Randomized Control Pilot Study Examining Treatment of Headache In The Post-Concussive Youth' showed that routine administration of oral analgesia improves the child's headache symptoms and helps with school re-entry one week post injury, compared to a standard care group defined as non routine administration of pain medications.

Objective Post Injury concussion and headache are problematic for children after mild traumatic brain injuries. There are no evidence based guidelines for the management of acute post concussive headache. The objectives of this study were to assess the efficacy of routine administration of analgesia on concussion headache and classify headaches using the IHS criteria.

Method A 4 arm open label pilot RCT study was conducted. The treatment arms were: (i) acetaminophen,(ii) ibuprofen, (iii) acetaminophen and ibuprofen and (iv) a standard control group. Eight to eighteen year olds presenting to emergency with headache 24-48 hours after their first concussion were recruited consecutively and sequentially randomized. Demographic data was collected, headache survey administered and standard concussion education given. Headaches were diarized over one week capturing the (i) number of headaches, (ii) headache days,(iii) headache intensity and (iv) return to school.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with a first time concussion
* english speaking
* presenting to Emergency with headache 24-48 hours post concussion
* normal Glascow Coma Scale
* 8-18 years of age

Exclusion Criteria

* postive findings on CT scan
* patient with cervical injury
* history of multiple concussions
* positive neurology
Study of Anlotinib in Patients With Primary Malignant Bone Tumors

To evaluate the safety and efficacy of patients with recurrent and metastatic bone tumors.


Eligibility Criteria:
Inclusion Criteria:

1. The patient volunteered to participate in this study and signed an informed consent;
2. Pathological diagnosis of osteosarcoma, chondrosarcoma, source of undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, derived bone giant cell tumor of bone or bone primary Ewing's sarcoma / primitive neuroectodermal tumor (PNET) tumor;
3. All patients were failed in chemotherapy (including anthracycline) or intolerance, recurrence or distant metastasis, and at least one measurable lesion (according to RECIST 1.1 criteria);
4. At the age of 14-70, less than 18 year old patients with body surface area to more than 1.5m2;
5. ECOG PS score: 0\~1 score (amputation patient's PS score is 0\~2), and the expected survival time is over March;
6. The main organs function within 7 days before the treatment, in accordance with the following criteria: the standard of blood routine examination (in 14 days without blood transfusion): The hemoglobin is greater than or equal to 90g/L (by multiple tumor metastasis induced anemia, hemoglobin = 85g/L); The neutrophil absolute value is more than 1.5 \* 109/L; Platelet over 80 \* 109/L. biochemical examination should comply with the following criteria: The total bilirubin is less than or equal to 1.5 Long ULN; The alanine aminotransferase and aspartate aminotransferase is less than or equal to 2.5ULN, such as liver metastasis, ALT and AST = 5ULN; The serum creatinine or creatinine clearance rate is greater than 1.5ULN 60ml/min; Doppler ultrasound assessment of the lower limit of normal value is more than the left ventricular ejection fraction (50%).
7. Women of childbearing age should use contraceptive measures must be agreed within 6 months in the study period and after the end of the study (such as IUD, pill or condoms); in the study before entering the group within 7 days of serum or urine pregnancy test is negative, and must be for patients with non lactation; men should agree to use contraceptive measures must be 6 months in the research period and the end of the study period after the patients.

Exclusion Criteria:

- Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication Hepatitis B virus patients with active replication (DNA\> 500 cps / mL), hepatitis C
Effect of Clove Oil and Menthol Lozenges on Post-extubation Sore Throat

In patients undergoing surgical intervention, endotracheal intubation, which is a part of the anesthesia procedure, can cause postoperative sore throat in patients. This situation causes difficulty in swallowing, inadequate nutrition and fluid intake, and prolongs the recovery process. In addition, sore throat is defined as a source of physical stress, which can lead to an increase in the incidence of postoperative morbidity and a decrease in patient satisfaction. This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat after surgery. Our aim was to provide evidence on the effectiveness of simple, low-cost menthol and clove oil lozenges in reducing sore throat after extubation, thus helping the patient recover.

This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat in patients after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65. Having had abdominal surgery. Being extubated within the first 8 hours after surgery. ASA class I-III. Mallampati class I-II. Glasgow Coma Scale (GCS) score 15

Exclusion Criteria:

* History of allergies.

  * Severe nausea and vomiting.
  * Being extubated after the first 8 hours after surgery.
  * Communication disorders
  * Mallampati class III-IV.
  * Glasgow Coma Scale (GCS) score \<15
Improving Adherence to Cognitive Rehabilitation

Purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on learning styles in improving attendance to cognitive training

This study is evaluating whether motivational enhancement can improve outcomes of cognitive rehabilitation in Veterans with schizophrenia spectrum disorders. Approximately 120 individuals will be randomized to either a 2-session motivational interview (MI, experimental condition) or a 2-session assessment and feedback on learning styles (CI, active control), and will then be asked to participate in 4 months of cognitive rehabilitation. Booster MI or CI sessions will be administered monthly over the course of the cognitive rehabilitation. Primary outcome is number of cognitive rehabilitation sessions attended.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of psychotic disorder
* 18 years old or older

Exclusion Criteria:

* meeting criteria for substance abuse/dependence in past 30 days
* psychiatric hospitalization in past 30 days
* change in psychiatric medications in past 30 days
* severe auditory/visual impairment
* evidence of developmental disability
The Analysis of Efficacy Factors for Autologous Platelet-Rich Plasma Therapy in the Treatment of Elbow Tendinopathy

To identify key factors influencing the effectiveness of platelet-rich plasma (PRP) therapy in treating elbow tendinopathy, a common degenerative condition.

This study focuses on evaluating the effectiveness and limitations of platelet-rich plasma (PRP) therapy in treating elbow tendinopathy, a degenerative condition that includes lateral epicondylitis (tennis elbow) and medial epicondylitis (golfer's elbow). These conditions cause pain and reduced function in the elbow, with lateral epicondylitis being more common.

PRP, a regenerative treatment made from the patient's own blood, contains platelets concentrated 3-5 times higher than normal blood, releasing growth factors like TGF-β, PDGF, IGF, and EGF, which help tissue repair. PRP therapy was first introduced for elbow tendinopathy in 2006 and has since been recognized for its potential in pain relief and healing, becoming a reimbursable treatment in Korea since 2023.

However, inconsistent clinical outcomes have been reported due to differences in PRP preparation methods and platelet concentrations. Research suggests that higher platelet counts and specific growth factors may enhance PRP effectiveness. The International Society on Thrombosis \& Haemostasis classifies PRP based on platelet concentration, with some studies indicating that higher levels of TGF-β and IL-1β improve outcomes.

This study aims to identify the key components of PRP that influence treatment success, focusing on platelet concentration and growth factor levels. The goal is to establish optimal PRP preparation guidelines to ensure consistent and effective results for elbow tendinopathy, ultimately improving patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 years or older
* Diagnosed with elbow tendinopathy
* Persistent pain despite receiving conservative treatment

Exclusion Criteria:

* Individuals with systemic infection at the time of study participation
* Patients with rheumatic diseases or inflammatory disorders
* Individuals with unstable systemic conditions affecting the cardiovascular, gastrointestinal, respiratory, or endocrine systems
* Any other cases deemed inappropriate for study participation by the investigator
Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.

The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.

This was a open-label, single center study conducted in the United States that evaluated the tolerability of Cetaphil® DermaControl™ skin care products used at least once daily for 22 days in male and female subjects age 7 to 11 with acne prone skin. There were 4 visits during the course of the study: screening (within 7 days of visit 1), visit 1(baseline /day1), visit 2 (day 8), and visit 3 (day 22/exit). Tolerability assessments were performed by a board certified dermatologist at all visits. Subjects completed the baseline skin care regimen questionnaire at visit 1. Hydration assessments were competed at visits 1, 2, and 3. A subject satisfaction questionnaire was completed at visit 3. Adverse event assessments were conducted for all subjects at every clinic visit after informed consent/assent was signed.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 7-11 years of age
* Subjects with acne-prone skin \[Global severity of acne (GSA) Score of 1 (almost clear) or 2 (mild) and any oiliness evaluation score or GSA Score of 0 (none) with an oiliness evaluation score greater than or equal to 1 (mild)\]

Exclusion Criteria:

* Subjects with any visible skin condition or facial hair that could interfere with the evaluations
* Subjects taking other medications, supplements, or non-prescription treatments that, in the opinion of the principal investigator/board certified dermatologist, could interfere with the test results including any regimen of steroidal/non steroidal anti-inflammatory drugs or antihistamines
* Subjects currently under the treatment for asthma or diabetes (insulin-dependent only)
* Subjects with abnormal pigmented vascular skin lesions, abnormal skin pigmentation, or body art (tattoos, permanent or temporary) on the face, which could interfere with subsequent evaluations of dermal responsiveness
Impact of Grafts and Endografts for Abdominal Aneurysms on Arterial Stiffness.

The purpose of this study is to evaluate by non-invasive methods the change in central hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic aneurysm repair.

Our main goal is to measure the changes in:

Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.

The measures will be done before the procedure and after them.

We will use the device called: SphygmocoR (Atcor Medical, Sydney, Australia).

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of abdominal aortic aneurysm requiring repair (open or endovascular) based on guidelines criteria for management.

Exclusion Criteria:

* Patients who don´t want to enter in the study.
* Patients who don´t want to sign the informed consent.
Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

Comparison between preemptive and postoperative intraarticular injection of tramadol on pain sensation after arthroscopy

220 patients assigned for therapeutic knee arthroscopy were divided into four equal groups in this prospective comparative study. All patients received IAI of 20 ml (0.5%) levopubivacaine alone in Group C; with 100 mg tramadol as PE (Group PE), at end of surgery (Group PO) or divided as 50 mg tramadol + 20 ml 0.25 % levobupivacaine as PE and 50 mg trmadol + 20 ml 0.25 % levobupivacaine as PO (Group PE/PO). Numeric rating scale (NRS) was used to assess pain sensation. Duration till request of rescue analgesia and number of requests were recorded. Patients' satisfaction concerning efficacy of PO analgesia was assessed using Iowa Satisfaction with Anesthesia Scale.

Eligibility Criteria:
Inclusion Criteria:

* Patient physical status according to American Society of Anesthesiology (ASA) classes I-II
* Patients free of general diseases prohibiting the use of local anesthesia.

Exclusion Criteria:

* Patients had allergy for local anesthetics or to tramadol
* Patients have psychological or neurological disorders inducing difficulty for evaluation of pain scoring.
Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease

The purpose of this study is to compare the efficacy and safety of BCT197 when added on to standard of care in adult subjects with acute respiratory exacerbations of chronic obstructive pulmonary disease requiring hospitalization. Additionally, the study will characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the study will be 26 weeks. Subjects will receive study treatment administration over a period of 5 days after randomization. It is expected that approximately 255 subjects will complete the study and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults
* Presence of an active exacerbation of the ongoing COPD requiring hospitalization for treatment
* Subjects with a documented diagnosis of COPD C or D
* Current smokers or ex-smokers
* A documented history of at least one moderate or severe COPD exacerbation in the 12 months preceding the Screening Visit that required antibiotics and/or systemic corticosteroid.
* Current regular treatment for COPD (for at least 2 months prior to the Screening Visit.

Exclusion Criteria:

* Age less than 40 years old
* Current diagnosis of asthma
* Subjects who have already completed treatment for the current exacerbation of COPD
* Subjects currently requiring intensive care unit (ICU) and/or mechanical ventilation
* Received a course of PDE4, p38 or PDE3/4 inhibitors within their respective defined washout periods.
Ullevål PersonalityProject

Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with personality disorder. It's main purpose is to test the effect of a long-term combined treatment program compared with eclectic individual therapy for patients with personality disorders.

The main study hypothesis is that long-term combined treatment is superior to eclectic individual therapy with respect to improvement in personality functioning, psychosocial functioning, symptoms, interpersonal problems, and self destructive behavior for poorly functioning patients with personality disorders.

Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with personality disorder. It's main purpose is to test the effect of a long-term combined treatment program compared with eclectic individual therapy for poorly functioning patients with personality disorders.

The experiment treatment is guided by written treatment guidelines and comprises:

1. 18 weeks intensive day treatment
2. followed by long-term outpatient combined group psychotherapy and individual therapy for 4 and 2,5 years respectively.

The control treatment comprises:

1. eclectic psychotherapy, here understood as psychotherapy according to the preference and regular practice of the therapist.

120 patients with personality disorders admitted to Department of personality psychiatry, Psychiatric division, Ullevål University Hospital are randomized to either experiment or control condition. The patients are evaluated at baseline and after 8, 18, 36, 72 months. The evaluations comprise a large battery of psychological tests and structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* Patients with personality disorders admitted to Department for personality psychiatry, Psychiatric division, Ullevål University Hospital

Exclusion Criteria:

* Schizotypal personality disorder, antisocial personaliy disorder, current alcohol or drug dependence, developmental disorders (e.g. Asperger), symptoms due to organic conditions, and lack of a permanent residence.
Kidney Histopathology After COVID-19 and SARS-CoV-2 Vaccination

The study aims to summarize kidney histopathological findings in patients with coronavirus disease 2019 (COVID-19) and post-severe acute respiratory syndrome-coronavirus-type 2 (SARS-CoV-2) vaccination.

The SARS-CoV-2 pandemic has had substantial global morbidity and mortality. While COVID-19 is most commonly characterized as a respiratory illness, extrapulmonary manifestations are a prominent part its clinical spectrum. Kidney disease is a common finding in COVID-19, and has also been rarely described after SARS-CoV-2 vaccination. The main objective of this study is to summarize kidney histopathological findings in patients with COVID-19 and post-SARS-COV-2 vaccination, in whom native kidney biopsy was performed and samples were obtained by the Nephropathology Section, Institute of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Eligibility Criteria:
Inclusion Criteria:

* being diagnosed with COVID-19 when kidney biopsy was performed
* history of recent homologous or heterogenous vaccine regimen comprising either vector-based vaccines or messenger ribonucleic acid-based vaccines

Exclusion Criteria:

* Patient refuses participation
Amino Acids Profiles in Premature Infants Receiving Nutritional Support

The aim of this study is to investigate the changes of amino acid metabolic profiles in different nutritional stages of preterm infants and determine the effects of nutritional intervention on the amino acid metabolic status of preterm infants.


Eligibility Criteria:
Inclusion Criteria:

Premature infants, and admitted to hospital within 24 hours after birth; Documentation of informed consent; In need of receiving parenteral nutrition after birth;

Exclusion Criteria:

Premature infants with a parenteral nutrition period of less than 3 days; Inborn error of metabolism; Chromosomal abnormalities or multiple malformations;
Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)

This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.

Patients meeting inclusion/exclusion criteria will be approached for study consent based on the time of hospital admission and the availability of an blood type compatible product. 300mL plasma units of COVID-19 convalescent patients will be utilized for transfusion. During a period of 14 days, the patient will be eligible to receive up to 10 units of plasma, to be completed with 4 hours as per institutional transfusion standard operating procedures. Transfusion by apheresis (plasma exchange) may be employed to reduce the risk of volume overload. The number of units to be used will be determined by the study team based on protocol inclusion and exclusion criteria, and clinical evaluation of the patient's severity and response.

Subjects will be followed for at least 60 days or up to 3 months following initial transfusion for adverse event monitoring and data collection.

Eligibility Criteria:
Inclusion Criteria:

Recipient must meet criteria outlined in the recent Investigational COVID-19 Convalescent Plasma - Emergency INDs (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds)

Exclusion Criteria:

1. History of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by Center of Disease Control National Healthcare Safety Network Hemovigilance Module \[see https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf\].
2. Has underlying uncompensated and untreatable end stage disease.
3. Fluid overload or other condition that would contraindicate administration of plasma