cyrilzakka/clinical-trials huggingface dataset:
Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate

The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.

Healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pMDI products according to a six-period cross-over design. Electrocardiograms (ECGs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer
* Willing and able to give informed consent
* Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
* Male and female subjects aged 18 to 55 years (inclusive)
* Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
* Any presence or history of a clinically significant allergy including any adverse reaction to study drug
* History of drug or alcohol abuse within the past 2 years
* Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
* Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
* Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
* If female, nursing, lactating or pregnant
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Surgery scheduled during the study or within 3 weeks after last dose
* History of familial long QT syndrome or history of sudden death in family members aged \< 30 years
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of dry eyes for at least 3 months.
* Ocular discomfort due to dry eyes.
* Presence of corneal and conjunctival staining.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women who are pregnant or lactating.
* Contact lens wear within 1 week before Screening and during the study.
* Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
* Punctal plugs or punctal occlusion initiated within 3 months of screening
* Other protocol-defined exclusion criteria may apply.
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence

This study is a randomized controlled phase II trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in colorectal cancer liver metastasis (CRLM) patients with high risk of locally recurrence. Researchers will compare the combination therapy with the postoperative chemotherapy alone to see if postoperative chemotherapy plus SBRT and immunotherapy can further reduce the risk of recurrence and metastasis after surgery.

40-50% of colorectal cancer patients have metastases at the time of diagnosis, of which liver metastases are the most common. Surgical resection is the most likely cure for CRLM patients, however, more than 50% of patients will experience recurrence within 2 years after resection of liver metastases. SBRT can be an effective and safe treatment modality, which can not only provide better local control of metastatic lesions, but also has a sensitizing immunotherapeutic effect. SBRT can effectively synergize with anti-PD-1/PD-L1 antibodies to activate the immune microenvironment of CRLM patients and improve survival. However, in CRLM patients after surgery, whether combining SBRT, immunotherapy and adjuvant chemotherapy results in better survival than chemotherapy alone, the evidence is insufficient.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years old, female and male
2. pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous)
3. Metastatic liver lesions \<= 5
4. Primary colorectal cancer under control
5. Absence of evidence of extra-hepatic diseases
6. Metastatic liver lesions received resection with insufficient margin (\<0.5cm) or R1/R2 resection
7. Karnofsky \>= 70
8. Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy
9. Without previous antitumoral immunotherapy
10. With good compliance
11. Signed the inform consent

Exclusion Criteria:

1. Pregnancy or breast-feeding women
2. History of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ)
3. History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders
4. Clinically serious heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
5. Immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents
6. Severe uncontrolled recurrent infections
7. Baseline blood and biochemical indicator do not meet the following criteria: neutrophils \>=1.5×10\^9/L, Hb \>=90g/L, PLT \>=100×10\^9/L, ALT/AST\<=2.5 ULN, Cr \<= 1ULN
8. Allergic to any component of the therapy
Evaluation of TTE Utilization in Medical Surgery Step-Down Unit

This is a non-randomized, un-blinded study to evaluate Caption Health guidance software in patients in the medical surgery step-down unit. Patients will be scanned by a trained hospitalist and up to 4 standard views will be obtained per participant: PLAX, PSAX-PM, AP4 and SubC4. Observations will be made regarding human factors and performance of the device.


Eligibility Criteria:
Inclusion Criteria: .

* Patients ≥18 years old
* Patients in the medical surgery step-down clinical setting
* Patients who consent to participating in the study

Exclusion Criteria: .

* ● Patients with emergent or urgent episodes of injury and illness that can lead to death or disability without rapid intervention

  * Unable to lie flat for study
  * Patients experiencing a known or suspected acute cardiac event at the time of evaluation
  * Patients with severe chest wall abnormalities
  * Patients who have undergone pneumonectomy
  * Patients with recent abdominal surgery
  * Patients unwilling or unable to give written informed consent
  * Principal Investigator determination to exclude the subject from participation
  * Investigators also have the right to withdraw patient from the study in the event of illness, adverse events, or other reasons concerning the health or well-being of the patient, or in the case of non-compliance.
Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass

This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal Females Age ≥ 45 years.
* Weight \> 45 kg and \< 90 kg
* Normal nasal examination at baseline.
* Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck

Exclusion Criteria:

* Serious Medical Condition
* History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
* Have a history of cancer within the past 5 years, except for basal cell carcinoma
* Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
* Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product
Surgical Activity During the Covid-19 Pandemic: Results for 112 Patients in a French Tertiary Care Center

Background

After the emergence of Covid-19 in China, Hubei Province, the epidemic quickly spread to Europe. France was quickly hit and the Croix-Rousse hospital at the Hospices Civils de Lyon was one of the first French university hospital to receive patients infected with Sars-COV2. The predicted massive influx of patients motivated the cancellation of all elective surgical procedures planned to free hospitalization beds and to free intensive care beds. Nevertheless, patients who had to be canceled had to be properly selected to avoid a life threatening. The retained surgical indications were surgical emergencies, oncologic surgery and organ transplantation.

The objective was to describe the organization of the Croix-Rousse hospital to allow the continuation of these surgical activities while limiting the exposure of patients to the Sars Cov2.


Eligibility Criteria:
Inclusion Criteria:

* surgical management
* \> 18 years old

Exclusion Criteria:

* \< 18 years old
Telerehabilitation vs Supervised Exercises in MS

Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a safe and effective rehabilitation tool for PwMS. A structured and personalized exercise program can improve physical fitness, functional capacity, quality of life and modifiable disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation method in PwMS. The purpose of this study is to investigate the effectiveness of exercise programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised exercise and home-based exercise programs for the PwMS.

Participants are randomly assigned to the structured supervised exercise or structured home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a week over a 12-weeks structured exercise program under the supervision of a physical therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked and controlled through telerehabilitation three times a week. All measurements pre-post intervention.

Eligibility Criteria:
Inclusion Criteria:

patients with:

1. Stable period at the time of application to the clinic
2. Expanded Disability Status Scale Levels between 2 - 6.5
3. Appropriate cognitive level to understand the exercises
4. No diseases to affect their participation in exercise programs

Exclusion Criteria:

patients with:

1. Poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation,
2. A new history of previous attacks
3. No reliable informed consent
ROTEM in Patients With Placenta Previa

The rotational thromboelastogram (ROTEM) test can be performed on patients with placenta previa/accreta/increta/percreta who have a high likelihood of massive bleeding, and the predictors can be identified by comparing the patients who actually show massive bleeding with those who do not.

Applying these predictive factors to pregnant women undergoing cesarean section after diagnosis of placenta previa/accreta/increta/percreta, it will be advantageous for the perioperative management because it is possible to select pregnant women with a factor of massive bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Cesarean section under spinal anesthesia
* Placenta previa
* Placenta accreta
* Placenta increta
* Placenta percreta

Exclusion Criteria:

* Coagulopathy
* Medication with antiplatelets or anticoagulants
Observe Abnormal Potential From the Offending Vessel to the Facial Muscles of HFS Patients

The pathophysiologic basis of hemifacial spasm is cross-transmission between different branches of the facial nerve. The hypothesis is that the cross-transmission is mediated by the sympathetic nerve fibers on the surface of the offending artery. The abnormal potential from the offending vessel to the facial muscles will be detected on hemifacial spasm patients, so as to determine if the sympathetic nerve fibers take part in the circuit of cross-transmission.

It's hypothesized that at the location where the facial nerve is compressed by an artery, ephaptic cross-transmission takes place between the nude facial nerve fibers and the sympathetic nerve fibers on the arterial surface. Thus action potentials could spread indirectly from one facial nerve fiber to several other facial nerve fibers (via the "bridge" of sympathetic fibers), or directly from the sympathetic fibers to facial nerve fibers. The investigators assume this is the electrophysiological basis of hemifacial spasm and its characteristic sign abnormal muscle response (AMR). If an abnormal potential from the offending artery to the facial muscles similar to AMR can be recorded, the hypothesis will be verified.

Eligibility Criteria:
Inclusion Criteria:

1. the age of 18-65 years old;
2. with typical hemifacial spasm symptoms;
3. with typical abnormal muscle response;
4. preoperative magnetic resonance imaging revealed obvious paraneural artery;
5. with informed consent.

Exclusion Criteria:

1. pregnant or lactating women;
2. accompanied by other serious diseases, including liver, kidney, cardiovascular diseases;
3. accompanied by mental illness or severe neurosis;
4. unable to express the subjective symptoms.
Low Back Pain - What's Next? Stratified Care Compared to Current Practice

Background Studies in the United Kingdom find the stratified care model of the STarT Back Tool (SBT) to be superior to usual care in primary care low back pain (LBP) patients. However, considerations on differences in health care and social systems across countries are required before taking steps towards any recommendations of implementing stratified care into other health care services.

Objective To investigate the effectiveness of the stratified care model of the SBT, when embedded into the regional disease management programs on LBP in primary care as compared to current best practice care.

Methods The study is a two-armed randomized controlled trial in Danish primary health care setting. In total 700 patients are included in the study.

The patients are randomised automatically by a developed database to; 1) Stratified care (treatment matched to stratification according to SBT) or 2) Control treatment (treatment based solely on clinical reasoning).

All data including patient consent is collected and monitored using a web-based data management system.

Eligibility Criteria:
Inclusion Criteria:

* patients found eligible for referral to physiotherapy by the general practitioner (GP)
* 18 years and above
* understand Danish language.

Exclusion Criteria:

* Serious pathology (malignancy, inflammatory arthritis, etc.),
* serious nerve root compression (cauda equina, paresis \<3),
* influential comorbidity, psychiatric illness, personality disorder, spinal surgery during the last 6 months, pregnancy, or already receiving physiotherapy treatment.
CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34)

With the introduction of the CoreValve™ Evolut R™ 34mm (Medtronic™) prosthesis, patients with severe symptomatic aortic stenosis (AS) and large aortic annulus have become eligible for transcatheter aortic valve implantation (TAVI). The aim of this study is to detect the number of TAVI candidates with large aortic annulus, and to evaluate the feasibility, efficacy, and safety of TAVI using the CoreValve™ Evolut R™ 34mm.

With the current transcatheter valves available in the market, is possible to cover a wide range of patients with diverse and complex anatomies. Nevertheless, there is a subgroup of patient with large aortic annulus (diameter \> 27 mm), in whom the implant of a transcatheter valve is not possible because there is no valve suitable for such as aortic annulus size.

With the introduction of the CoreValveTM EvolutionTM R 34mm, patients with an aorttic annulus dimension up to 29 mm in diameter have become eligible for TAVI. However, there is a lack of information regarding the number of patient with AS and this particular anatomy of the aortic annulus. Italian and Dutch registries have reported a prevalence between 6.5 to 12.3% with large aortic annulus requiring the previous CoreValveTM 31mm. Yet, there is no reported data regarding this population of patients in Spain. Also, the clinical use of this larger prosthesis covers a wider range of aortic rings and may enchance the procedural challenges, such as a little margin for proper valve placement, more likelihood of interference with mitral valve function and damage to the cardiac conduction system during the prosthesis deployment.

So far, no studies regarding clinical experiences with the CoreValveTM EvolutionTM R 34mm have been published. The scarce information currently available with this new device may be distant from those found in its daily clinical use in non-selected patients. The results of this Spanish nationwide registry will help to answer a scientific need of information regarding acute procedural results and mid

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age.
* Subject accepted participate and signed informed consent.
* Subject with severe symptomatic AS patients selected for TAVI by the Heart Team of each participating hospital.
* Patients anatomically suitable for the implantation of a CoreValve™ Evolut R™ 34mm with the approved indications by any feasible and appropriate vascular routes.
* Subject must agree to undergo all follow-up visits

Exclusion Criteria:

* High probability of non-adherence to the follow-up requirements.
* Explicit refusal of participation in the registry.
Aciclovir Versus Placebo for HSV-2 Meningitis

To determine whether active treatment with (val)acyclovir is superior for treatment of viral meningitis compared with placebo assessed by numbers meeting a primary, objective endpoint at 7 days after randomisation


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age admitted on suspicion of viral meningitis defined as:

  1. A clinical presentation consistent with viral meningitis (e.g. headache, nuchal rigidity, photophobia, or fever) AND
  2. Cerebrospinal fluid (CSF) pleocytosis (\>4 leukocytes x 106/L) AND
  3. HSV-2 positive by PCR of the CSF
  4. Glasgow Coma Scale score of 15 AND
  5. Ability to absorb oral medications

Exclusion Criteria:

* Patients fulfilling any of the following criteria will be excluded:

  1. Encephalitis as defined by the International Encephalitis Consortium if diagnosed during standard care (see Glossary)20
  2. Transverse myelitis as defined by the Transverse Myelitis Consortium Working Group if diagnosed during standard care (see Glossary)21
  3. Severe immuno-compromise defined as an ongoing need for biological- or chemotherapy (e.g. natalizumab), prednisolone \>20 mg/day for ≥14 days, uncontrolled HIV/AIDS (see glossary), haematological malignancies, and organ transplant recipients14,18,22
  4. Moderate to severe concomitant genital herpes requiring systemic aciclovir
  5. Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women)
  6. Hepatic impairment (aspartate aminotransferase or alanine aminotransferase levels \>5 times the upper limit of normal)
  7. Impaired renal function (estimated glomerular filtration rate \<25 mL/min)
  8. Intolerance to (val)aciclovir
  9. Probenecid treatment
  10. Systemic antiviral therapy with an antiherpetic effect for \>24 hours
  11. Previous enrolment into this trial
Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive Monitor

A prospective observational study in patients admitted with an acute cardiac disease, in which the PPG-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. Data will be crossed with gathered clinical and laboratory data, to study the device's ability to detect acute hemodynamic and respiratory changes during hospitalization, and gathering workflow information from the nursing staff.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years and above admitted to the Cardiac ICU due to an acute cardiac event.

Exclusion Criteria:

* Pregnant women, subjects under the age of 18 years.
Effect of Cognitive Behavioral Play Intervention and Epilepsy

The goal of this clinical trial is to assess the effectiveness of Cognitive Behavioral Play Therapy interventions in patients with epilepsy.

Children with epilepsy will be randomly assigned to one of two intervention conditions: the experimental group will receive cognitive-behavioral play intervention, while the control group will engage in free play. Assessments will be done at the start (T0) and end (T1) of the intervention, measuring behaviors, coping strategies, positive thinking, problem-solving, and quality of life.

Cognitive-Behavioral Play Therapy (CBPT) adapts Cognitive-Behavioral Therapy techniques into a play-based intervention for preschool and school-age children, especially for those facing challenges like hospitalization or chronic illnesses. Studies show that play has therapeutic value, helping children understand critical events, reduce anxiety, and cope with illness. This research aims to explore how CBPT can be applied in hospitals, specifically for children with epilepsy, to improve their quality of life, enhance problem-solving, and foster positive coping strategies. The goal is to validate CBPT as a supportive tool for enhancing psycho-emotional development and complementing medical care in hospital settings.

The study proposes a randomized controlled trial with two groups: children with epilepsy will be randomly assigned to either the cognitive-behavioral play intervention or free play. The study will assess internalizing and externalizing behaviors, coping strategies, positive thinking, problem-solving skills, and quality of life at baseline (T0) and after the 8 intervention sessions (T1).

The goal is to determine whether cognitive-behavioral play improves quality of life more than free play.

Both groups will participate in 8 weekly 40-minute play sessions, with an initial and final meeting to administer the questionnaires.

The psychologist conducting the assessments will be unaware of group assignments.

The play scenarios for both groups will be identical and based on common issues faced by children with epilepsy.

Eligibility Criteria:
For the purposes of the study, children aged between 6 and 10 years, of both sexes, will be recruited.

- inclusion criteria Children diagnosed with the following types of epilepsy will be included: childhood self-limiting focal epilepsy (SeLFE); childhood absence epilepsy (CAE); self-limiting centrotemporal paroxysmal epilepsy (SeLECTS); self-limiting epilepsy with autonomic seizures (SeLEAS); childhood occipital epilepsy (COVE); photosensitive occipital lobe epilepsy (POLE).

Exclusion criteria:

* Children with epilepsy in comorbidity with cognitive disabilities (the relevant cognitive disabilities must be specified with IQ scores)
* reduced visual or expressive hearing acuity (visually impaired or deaf) will be excluded.