cyrilzakka/clinical-trials huggingface dataset:
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.

The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants.

The participation duration was approximately 6 months for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Aged 9 to 49 years on the day of inclusion
* A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. To be considered of non-childbearing potential, a female should have been pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration
* Assent form or informed consent form had been signed and dated by the participant (based on local regulations), and if applicable informed consent form had been signed and dated by the parent(s) or another legally acceptable representative

Exclusion Criteria:

* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
* Thrombocytopenia
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment
* Personal or family history of Guillain-Barre Syndrome (GBS)
* Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effect of Aerobic Exercises on Trace Elements in Post-menopausal Women After Radiotherapy

This study will be conducted on 28 participants who are survivors of breast cancer and underwent radiotherapy. The purpose of the current study is to investigate the effect of aerobic exercises on quality of life and serum levels of Zinc, Copper and iron in post-menopausal women who received radiotherapy after surviving breast cancer.

Breast cancer (BC) is the most common type of cancer in women globally. Several studies observed changes in the serum blood levels of trace elements in BC. Essential trace elements have relevant functions in a large number of cellular processes, with multiple roles in the correct functioning of metabolic enzymes.

There were previous trials to investigate the effect of exercise on trace elements in different populations as in the elite sportsmen. Some other studies to investigate the effect of exercise on breast cancer survivors for instance (Duijts et al., 2011) stated that physical exercise has effects on psychosocial functioning and health-related quality of life in breast cancer patients and survivors. Also, (Lambrigts et al., 2022) stated that aerobic exercise is the possible easiest solution to improve quality of life. Lastly, (Lipsett et al., 2017) proved that exercise during adjuvant radiotherapy for breast cancer has positive impact on reducing fatigue and improve quality of life . However, there are no previous studies to investigate the effect of exercise on trace elements in BC patients nor identifying the optimal dose or parameters of the exercise. So, this study is an attempt to add to the clinical knowledge in this field as it will be the first one that investigates the effect of aerobic exercise on trace elements in women survived BC.

Eligibility Criteria:
Inclusion Criteria:

* All postmenopausal women with breast cancer and received radiotherapy immediately at the end of radiotherapy or max six months to one year in each group. after clinically diagnosed by Oncologist with breast cancer Stage I and II .
* Their ages will range from 50-60 years old.
* Good general Health (ECOG performance status 0-1).
* Voluntary acceptance of participation in the study.

Exclusion Criteria:

* Systematic chronic diseases (respiratory diseases, cardiovascular diseases...etc)
* Cognitive dysfunction as well as neuromuscular or musculoskeletal impairment or disease affecting postural control or motion pattern.
* Professional athletes.
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia (IH). The objectives of this study are two-fold: 1) To evaluate the efficacy of BTD-001 in subjects with IH as reflected by changes in cognitive, sleep, functional, and quality-of-life measures and 2) To characterize the safety and tolerability of oral BTD-001 administered to subjects with IH.

Eligibility Criteria:
Inclusion Criteria:

* Males or Females age 18 to 70 years old
* Onset of hypersomnia between age 10 and 30 years of age
* An Epworth Sleepiness Scale score of greater than or equal to 11
* Able to comply with requirements for concomitant medications and consumption of caffeine, alcohol, tobacco and nicotine (if on stimulants, agree to adhere to stable regimen throughout the trial)
* Females with a negative pregnancy test AND who are non-lactating
* Sexually active females of childbearing potential must be willing to use a highly effective method of birth control
* Sexually active males must have a vasectomy or use condoms

Exclusion Criteria:

* History of any disorder causing hypersomnia other than IH
* Evidence of circadian-rhythm disorder
* Sleep apnea syndrome
* Use of CPAP
* Obese subjects with BMI greater than or equal to 35kg/m2
* History of or current seizure disorder or history of syncope, unexplained loss of consciousnesses or seizure in the past 3 years as well as any past history of benzodiazepine and/or barbiturate and/or alcohol-related withdrawal seizures
* Columbia-Suicide Severity Rating Scale (C-SSRS) findings consistent with significant history of or current suicidal ideation or behavior
* Subjects who fail to wash out medications for IH or any other prohibited medications
* Positive toxicology screen test during the Screening or Baseline Visits.
* Clinically significant abnormal findings from physical, electrocardiogram (ECG) or laboratory assessments at Screening
* History of or current significant pulmonary, cardiac, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carinomas or local cervical squamous cell carcinoma resolved after resection) or hypothyroidism (unless euthyroid at Screening Visit and treated with a stable dose of medication for at least 3 months prior to the Baseline Visit).
* Participation in a clinical drug trial within 4 weeks of Screening Visit
Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

Evaluation the efficacy of chloroquine and hydroxychloroquine in the treatment of proliferative lupus nephritis class III and IV in children and adolescents and evaluate the side effects of both drugs .

All patients will fulfill the diagnostic criteria of SLE. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. The criteria set developed by the American College of Rheumatology (ACR) and diagnosed wih lupus nephritis class III and IV .

Inclusion Criteria:

* Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.
* All patients will be received steroids , MMF and Angiotensin Converting Enzyme.

Exclusion Criteria:

* Patients diagnosed with lupus nephritis class I,II,V and VI.
* Patients received Cyclophosphamide in stead of MMF.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.
* All patients will be received steroids , MMF and Angiotensin Converting Enzyme.

Exclusion Criteria:

* Patients diagnosed with lupus nephritis class I,II,V and VI.
* Patients received Cyclophosphamide in stead of MMF.
Dexmedetomidine in IVRA

A prospective randomized controlled double-blinded study will be conducted on 90 patients assigned randomly into three equal groups,

After obtaining approval of the medical and ethical committee of Menoufia University \& Nasser Institute for Research and Treatment, an informed and written consent from the patients, a prospective controlled randomized double blinded study will be performed

Sample size:

MedCalc® version 12.3.0.0 program "Ostend, Belgium" was used for calculations of sample size, statistical calculator based on 95% confidence interval and power of the study 80% with α error 5%, According to a previous study (13), showed that the duration of tourniquet time in group A was mean 51.60±5.157 and Group B was mean 53.80±4.773, with p-value \>0.05, while Quality of block of excellent in group A 83.3% and group B 90%, it turns out that there is success in the group B compared to group A, but there is no difference. So it can be relied upon in this study, based on this assumption, sample size was calculated according to these values produced a minimal samples size of 86 cases were enough to find such a difference. Assuming a drop-out ratio of 5%, the sample size will be 90 cases, subdivided into three groups 30 cases in each group. Patients will be randomly categorized into three equal groups (30 patients each): The patients will be randomly allocated to one of these three groups, using a computer-generated sequence of random numbers and a sealed envelope technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients of ASA class I and II.
* Patients of either sex.
* Patients aged between 20-70 years.
* Patients scheduled for forearm and hand surgery lasting for about 60 minutes.

Exclusion Criteria:

* Patient with known hypersensitivity to any study medications.
* Patient with Severe peripheral vascular disease and neurological disease.
* Where use of tourniquet will be either not possible or contraindicated.
* Patient with Hemolytic diathesis specially sickle cell anemia, epilepsy, diabetes mellitus, hypertension, cardiovascular disease like myocardial infarction, cardiac arrhythmias, heart block and altered mentation.
* Procedures lasting for more than 90 min will be also not considered.
* Therapy with adrenergic receptor antagonist, calcium channel blocker and ACE inhibitors.
* Patient with impaired liver function.
The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

The recovery of walking ability is one of the primary rehabilitation goals for children with neurological impairment. The aim of the study is to investigate the clinical effectiveness of rehabilitation treatments based of Robotic-Assisted Gait Training (RAGT). Additional goals of the research are to identify the specific effects of RAGT in children with different etiologies (acquired brain injury and cerebral palsy) and with different levels of function (according to the Gross Motor Function Classification System).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acquired brain injury in pediatric age and adolescence (4 to 18 years) or cerebral palsy;
* Femur length of at least 23 cm;
* Patients able to signal pain, fear or discomfort reliably and to follow simple instructions.

Exclusion Criteria:

* injection of botulinum toxin during the 6 months prior to the enrollment;
* oral medications reducing muscle tone;
* previous orthopedic surgery;
* severe lower-extremity contractures;
* fractures or osseous instabilities;
* osteoporosis;
* contraindication of full body load due to previous surgeries;
* severe retarded bone growth;
* unhealed skin lesions in the lower-extremities;
* thromboembolic diseases
* cardiovascular instability
* acute or progressive neurological disorders
* aggressive or self-harming behavior.
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device

The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.

The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation functional capacities of the patient's foot. It will be assessed with "general sub-score" of the EFAS questionnaire determined during the postoperative visit at 6 months.

The evaluation of quality of life scores, angular correction, bone consolidation and occurrence of adverse events will also be carried out.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a hallux valgus foot pathology requiring correction
* First line operation
* Use of the medical device concerned PECA Bunion
* Unilateral operation
* Patient aged 18 or over
* Isolated hallux valgus correction, without associated surgical procedures
* Patient able to respect the prescriptions and recommendations of his surgeon
* Patient able to read and understand the information note on the objectives of the study and the collection of their data
* Patient able to sign a consent form

Exclusion Criteria:

* Patient with a contraindication to the device under investigation,
* Simultaneous participation in another clinical investigation protocol,
* Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors.
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.

This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an emergent coronary procedure(within 60 minutes from admission)

Exclusion Criteria:

* On dialysis
* Pregnancy
* Past use of bicarbonate or N-Acetyl-Cystein in 48hr
* Past exposure to contrast media in 48hr
* Circulatory insufficiency with lactic acidosis.
PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement

The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen

Subjects will be randomized to receive perioperative dosing of either:

1. Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR,
2. IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules).

Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Able to provide written consent
* Able to read and write in English
* Weighing over 50 kg
* Will undergo total hip or total knee joint replacement

Exclusion Criteria:

* Non-verbal patients
* Unable to use numeric pain scale
* Allergic to the test article
* Documented hepatic impairment or failure
* Current illicit drug use
* Requires traumatic or emergent surgery
* Pregnant women
* Women who are breastfeeding
* Prisoners
* Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
* Unable to swallow oral capsules
Neural Functioning of Feeding Centers in Obese Youth

To explore whether obese adolescents with insulin resistance and relative low leptin levels exhibit functional alterations of the neuronal circuits involved in the regulation of energy metabolism and food seeking behaviors.

We here propose to test the hypothesis that the reward circuitry is dysregulated in obese adolescents and is related to the degree of insulin resistance and hyperinsulinemia.

Functional Magnetic Resonance Imaging (fMRI) provides a non-invasive method to assess the functional pathways affected by nutrient ingestion and therefore can help answer important questions regarding potential differences in the response of brain regions involved in feeding.

Eligibility Criteria:
Inclusion Criteria:

* Obese adolescents
* Good general health,
* taking no medication on a chronic basis
* Age 12 to 17 yrs,
* in puberty (girls and boys: Tanner stage II - IV)

Obese Insulin Resistant Adolescents

* (BMI\> 95th)
* (WBISI\<1.2 plus a low adiponectin \<6 ug/dl and
* high triglyceride levels \>130mg/dl)

Obese Insulin Sensitive Adolescents

* (BMI\>95th)
* (WBISI \>3) plus high adiponectin \>8 ug/ml and
* triglyceride levels \> 80 mg/dl Girls who begin menstruating must have a negative pregnancy test during the study

Eligibility criteria for healthy non-obese children and adolescents:

* Brother or sister with obesity
* Age 12 to 17 years
* Normal fasting glucose and lipids in the child, and
* normal OGTT
* No use of any medication known to affect glucose, lipid metabolism and inflammation
* No endocrinopathies
* No use of any antipsychotic medication
* BMI \>25th to \<75th ( Center for Disease Control (CDC) BMI Charts)
* Minimum weight of 90lbs (CDC Growth Charts)

Exclusion Criteria

* Baseline creatinine \>1.0 mg
* Pregnancy
* Presence of endocrinopathies (e.g. Cushing syndrome)
* Cardiac or pulmonary or other significant chronic illness
* Adolescents with psychiatric disorder or with substance abuse determined via self-report.
* Use of anorexic agents No metal implants
I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination

This trial studies how well a multi-level health system-based intervention works in improving human papillomavirus (HPV) vaccine initiation and completion among children in health systems in four Appalachian states. Utilizing educational and promotional materials and electronic health record reminders, may improve the uptake of the HPV vaccine in children and young adults, ultimately preventing the development of cervical cancer.

PRIMARY OBJECTIVE:

I. Test the effectiveness of a multi-level intervention (MLI) directed at clinics, providers, and patients (parents of children aged 11-12) to improve HPV vaccine initiation and completion in health systems in four Appalachian states (Kentucky \[KY\], Ohio \[OH\], West Virginia \[WV,\] and Virginia \[VA\]) among children aged 11-12 and assess the effectiveness of the intervention program among subgroups, e.g., females versus (vs) males.

SECONDARY OBJECTIVES:

I. Assess sustainability of the intervention. II. Assess cost impacts of the intervention III. Assess changes in clinic practices that occur as a result of the intervention in terms of staff responsibilities for the vaccination process and reducing missed opportunities for vaccination.

IV. Assess whether interventions focused on 13-26 year olds increases catch-up vaccination.

V. Examine changes in knowledge and attitudes of providers via educational session pre-post surveys.

VI. Satisfaction with the intervention at the multiple levels.

OUTLINE: Health systems are randomized to 1 of 2 arms.

ARM I (EARLY INTERVENTION): Health systems receive educational materials consisting of posters, brochures and table tents. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination.

ARM II (DELAYED INTERVENTION): Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I.

Eligibility Criteria:
Inclusion Criteria:

CLINIC

* Located in one of the counties that are part of this program
* Provides care to patients aged 11-26
* Provides immunizations

HEALTH CARE PROVIDERS (PHYSICIANS, NURSES) AND OFFICE STAFF

* Practicing in a clinic in one of the participating health systems
* Personnel involved in the vaccine process (determined by individual clinics)
* Able to speak, read, and write English
ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial

A substantial proporation of patients with biliary tract malignancies still experience disease recurrence after curative resection. ctDNA-based minimal residual disease (MRD) method has been widely used to monitor postoperative recurrence in solid cancers, but few studies have been reported in biliary tract cancers.

The present clinical trial aims to elucidate the correlation between the postoperative ctDNA status and the prognosis of patients with biliary tract cancers, and evaluate whether ctDNA could better predict patients' recurrence and guide clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age on the day of signing informed consent.
2. Clinically diagnosed as BTC before surgery and confirmed by pathology after surgery.
3. Stage I-III tumor according to the UICC/AJCC TNM staging system (8th edition in 2017), meeting the indications for radical surgery and are planned to undergo radical treatment. Those who do not undergo radical surgery will be excluded.
4. Patients must have a performance status of ≤1 on the ECOG Performance Scale.
5. Patients must have survival of \> 6 months after surgery
6. Serological tumor indicators (CEA, CA19-9) and imaging data ( CT and/or MRI, PET-CT) were complete.
7. Blood biochemical indicators meet surgical standards
8. Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

Exclusion Criteria:

1. Patients with recurrent biliary tract tumors
2. Patients with hepatobiliary mixed tumors
3. Patients with malignant tumors of other organs that have not been cured before.
4. History of organ transplant or allogeneic stem cell transplant
5. Patients with severe infections that are active or poorly controlled clinically
6. patients who are cognitively impaired or with known psychiatric disorders, and/or substance abuse
7. pregnant or lactating women
8. Failed to sign informed consent
9. Other conditions that researchers judged inappropriate for inclusion
PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy
* Patients for whom the treating physician has decided to initiate treatment with Tarceva

Exclusion Criteria:

* Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component
* Current participation in a clinical trial evaluating an anticancer treatment