cyrilzakka/clinical-trials huggingface dataset:
Single and Multiple Ascending Dose Study of AER-01

This is a first-in-human, randomized, double-blind, placebo-controlled, Phase 1 study of AER-01 (solution for inhalation, delivered via nebulizer) to assess the safety, tolerability and PK of AER-01. The study will be conducted in 2 parts: a single ascending dose (SAD) part in HVs (Part A) and a 7-day multiple ascending dose (MAD) part in HVs(Part B).


Eligibility Criteria:
Inclusion Criteria Health Volunteers:

* Healthy volunteers: Male or female aged ≥18 to ≤65 years.
* Current non-smoker or casual smoker Participants
* Females must not be pregnant or lactating

Exclusion Criteria:

* History of unstable medical conditions or major surgical procedures over the 12 months prior to Screening.
* History or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (excluding history of recurrent urinary tract infection), neurologic (excluding history of migraine), dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the PI or designee might obfuscate the study data.
* History of malignancy of any type, other than in situ cervical cancer or surgically excised non melanomatous skin cancers, within 5 years before Screening. Part B Participants with COPD and Moderate Airflow Limitation
* Has evidence of significant lung restriction on pulmonary function testing or a history of interstitial lung disease (including sarcoidosis and idiopathic pulmonary fibrosis), severe bronchiectasis, cystic fibrosis (asthma is not an exclusion.
Association of Serum Ferritin and Bone Mineral Density With Bone Metabolism in Chinese Healthy Postmenopausal Women

Large amounts of experimental and animal evidence have confirmed that iron accumulation is associated with bone loss. However, it is still lack of the clinical studies relating iron accumulation to bone loss, especially in the pathological conditions during our Chinese. In this study, the investigators aim to assess the association between the levels of serum ferritin and bone mineral density in Chinese healthy postmenopausal women.

For the past few years, an increasing number of in vitro studies show the association of iron accumulation with bone loss, particularly in postmenopausal women. And body iron accumulation is accurately reflected by levels of serum ferritin in clinic. The levels of serum ferritin among healthy women are about 13-150μg/L, and we give a definition of iron accumulation when serum ferritin range from 500μg/L to 1000 μg/L. How will the bone mineral density change in iron accumulation? The investigators intend to perform this study to explore and establish the relational function and logical function between serum ferritin, bone mineral density and biochemical markers of bone metabolism in Chinese healthy postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

1. healthy postmenopausal women
2. subjects aged 55 years or older

Exclusion Criteria:

1. subjects with acute or chronic inflammatory or infectious diseases
2. chronic liver or renal diseases
3. history of transfusion or iron therapy in the previous year
4. history of drug therapy such as bisphosphonates and glucocorticoids, which might have affected bone metabolism
5. subjects with hematonosis
Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Digital Diagnosis Platform

The main objective will be to determine the effectiveness of home non-invasive ventilation by flow-time and time-pressure curves analysis in a cohort of patients with this treatment by digital diagnosis platform.

A multicenter study with observational prospective design will be implemented on 3 spanish hospitals in Barcelona. Inclusion criteria will be equivalent sample size of patients with restrictive lung disease, neuromuscular pathology and hypoventilation-obesity.

Digital diagnosis platform will be used to incorporate and unify signals of different medical devices: a pneumotachograph on branch ventilator that captures pressure and flow-time signals, inductance plethysmography used to like a patient effort sensor and portable pulse oximeter recordings. Nocturnal polygraphic or polysomnographic tracings performed and recorded on sites will be processed systematically by main asynchronies diagnosis algorithms between patient and ventilator. These algorithms providing global and fractionated asynchronies count based on time, leaks or saturation criteria which will be used to compared effective ventilation phases and phases with nocturnal desaturations. Therefore, prevalence and asynchronies model on home NIV can be determine establishing the correlation between desaturation phases and respiratory events and identifying minimum tolerable leak level to keep adequate ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Home non-invasive mechanical ventilation and clinical stability at least of 6 months ( no acute episode with admission on 2 months before)
* Mean Ventilator compliance \> 4 h/ per night on screening visit
* Signed informed consent form previously

Exclusion Criteria:

* Ventilation with oxygen join system.
The Effects of Different Types of Music on Patients Undergoing Thyroid Surgery

This study was conducted to investigate the effect preoperative music interventions on anxiety and postoperative comfort level in patients.

Objective: This study was conducted to investigate the effect of preoperative music interventions on anxiety and postoperative comfort levels in patients.

Design: A randomized controlled quasi-experimental design was used. Methods: This study was conducted in the general surgery clinic of a university hospital in Diyarbakır, Turkey. A total of 100 patients (47 in the intervention and 53 in the control group) participated in the study by randomization. Personal Information Form, hemodynamic parameters, and State-Trait Anxiety Inventory were used for data collection. The State part of the State-Trait Anxiety Inventory was re-administered to the intervention group after the music intervention. In the postoperative period, hemodynamic parameters of all patients in both groups were monitoredş and the Perianesthesia Comfort Questionnaire was administered. SPSS 25.0 software was used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18-65,
* Hospitalized for 24 hours after surgery,
* without cognitive impairment
* consenting to participate

Exclusion Criteria:

* Individuals under the age of 18 and over the age of 65
* Individuals with cognitive impairment
* Individuals who declined to participate in the study
Vivity Study in Taiwan

The aim of study is to evaluate the quality of vision after bilateral Vivity or Vivity toric EDOF IOLs implantation in Taiwan.

This study was a prospective, single arm study. The inclusion criteria for this study were the presence of cataracts in both eyes and corrected distance visual acuity (CDVA) of both eyes under 20/40, who received bilateral Vivity IOL implantation after cataract surgery, targeting emmetropia or mini-monovision of both eyes. Phacoemulsification cataract surgery was performed on all patients. The exclusion criteria were complicated cataract; corneal opacities or irregularities; severe dry eye (Schirmer's test I ≤ 5 mm); amblyopia; anisometropia; surgical complications such as posterior capsular bag rupture, vitreous loss, or IOL tilt/decentration; coexisting ocular pathologies such as glaucoma, nondilating pupil, history of intraocular surgery, refractive surgery, or retinopathy; optic nerve or macular diseases; and refusal or inability to maintain follow-up. When corneal astigmatism was more than 0.75 diopters (D), a toric IOL was implanted.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age-related cataract requiring surgery treatment
* Patient who received bilateral, uneventful implantation of Vivity IOLs
* Patient's IOL power is between 10-30D, and T2-T6 for toric correction
* Cataract grade 0\~3 based on the Wisconsin cataract grading system

  • Exclusion criteria:
* Cataract grade 4\~5 based on the Wisconsin cataract grading system
* Patient's IOL power is outside of 10-30D or T2-T6 for toric correction
* Patient with the following ocular comorbidities:
* Corneal opacities or irregularities;
* Severe dry eye;
* Amblyopia;
* Glaucoma;
* Non-dilating pupil;
* History of intraocular surgery, laser therapy, or retinopathy;
* Optic nerve or macular diseases;
* Uncontrolled diabetic mellitus or systemic immune disease;
* Refusal or unable to maintain follow-up
Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients

Fluid therapy in trauma patients is considered one of the common challenges in daily practice. Both crystalloids and colloids can be used to maintain adequate blood volume and tissue perfusion but there is an ongoing debate as both of them could affect coagulation and renal function. The latest generation of the commercially available Hydroxy Ethyl Starch (HES) solutions was developed to improve pharmacokinetics and safety profile of HES, minimizing adverse effects such as impairment of blood coagulation or renal function. But data on early fluid resuscitation in trauma patients with these starches are limited and its safety on coagulation and renal function is still questioned.

Fluid resuscitation is a fundamental of the initial management and resuscitation of trauma patients to preserve or restore normovolemia, cardiac output, tissue perfusion, and correcting coagulopathy and acid-base balance during massive blood loss, yet fluid therapy in trauma patients is considered one of the common challenges in our daily practice with a lot of controversies and recommendations changing from using crystalloids, colloids, and/or packed red blood cells. Also, fluid availability which does not necessarily matches the best fluid needed for the patient impacts the physician choice of fluids especially when blood is not available.Both crystalloids and colloids can be used to maintain adequate blood volume and tissue perfusion. But both of them could affect coagulation and renal function. Both crystalloids and colloids decrease concentration of coagulation factors and number of platelets causing dilutional coagulopathy. Moreover, synthetic colloids impair polymerization of fibrin and platelet function, aggravating coagulopathic state. So, their use may therefore increase blood loss. As, all hydroxyethyl starch (HES) colloid solutions are excreted through the kidneys and other ways of excretion are negligible a lot of clinical trials have raised concerns about the renal safety of HES due to observed high frequency of acute kidney injury and high mortality rates in critically ill patients.These effects depend on the pharmacokinetic properties of the HES used, which determines the HES plasma concentrations over time, in vivo molecular weight (Mw), and maximum doses used. The latest generation of the commercially available HES solutions the medium-Mw starch, HES 130/0.4 (6%, Voluven®), was developed to improve pharmacokinetics and to improve the safety profile of HES, minimizing adverse effects such as impairment of blood coagulation or renal function.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patients in hemorrhagic shock
* Expected delay in blood and blood products transfusion for more than 40 minutes.

Exclusion Criteria:

* Known chronic renal disease
* Known chronic liver disease
* Known coagulopathy
* Known allergy to Hydroxyethyl starch
* Known pregnancy
My Type 2 Diabetes: Person-centred Health Care

The Type 2 diabetes (T2D) project is a research and innovation project that will create a new comprehensive, participant-centered service model for interaction, increased physical activity, self-management, distance monitoring and lifestyle change for patients with type 2 diabetes. Central to the degree of innovation is a new model for interaction and use of technology for distance monitoring and coping.

Type 2 diabetes is both physically and mentally stressful. At the same time, it requires a high individual effort, which can be demanding. Good mental health is necessary to be able to manage and control diabetes in a healthy and effective way. Therefore, we want to create an offer that takes care of the whole person, and physically as well as mentally.

Personal follow-up Based on surveys and conversations, the study participant and a contact person will prepare a 12-week plan that will be implemented with self-measurements and follow-up from the contact person. The plan will consist of the activities that best suit the participant's needs. It can be physical activity, diet course, health competence, motivation and psychosocial intervention that will be useful for the participant. After 12 weeks, the implementation will be evaluated.

Several new technological solutions are developed and will be used during the project period. A digital tool for mapping of the individuals needs will be an important part of the survey that is done during start-up. Activity clocks will be used for measuring steps, heart rate, and number of personalized activity index (PAI). An online portal for communication and interaction will make information easily accessible to users, simplify distance follow-up and communication flow.

The intervention will take place at two Healthy Life Centres. A Healthy Life Centre is an interdisciplinary primary health care service which offers effective, knowledge-based measures for people with, or in high risk of disease, who need support in health behaviour change and in coping health problems and chronic disease.

The Healthy Life Centre is part of the public health care service in the municipality. Healthy Life Centre programs have a patient centred approach and aim at strengthening the individual's control of his or her own health.

The intervention study starts in two municipalities in Møre og Romsdal, and the goal is to make the offer national.

Eligibility Criteria:
Inclusion Criteria:

• Type 2 diabetes

Exclusion Criteria:

* Unstable cardiovascular disease
* Severe chronic obstructive pulmonary disease (COPD)
Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation.

Preoperative fitness is known to predict postoperative outcomes following lower limb arthroplasty, but many patients, especially the most fragile, arrive at surgery with reduced mobility and functional capacity.

Prehabilitation (Prehab) encompasses a series of interventions that are intended to help patients improve their physical state and psychological well-being pre-intervention to reduce the days of hospitalization and the number of post-operative complications. Patients who participate in Prehab require less postoperative care and consequently have less impact on the cost of the healthcare system. However, adherence to a face-to-face program is usually poor and presents both organizational and psychophysical barriers. In the last years, telerehabilitation has proven to be a viable alternative to face-to-face treatment and has already been adopted for the Prehab. Electrostimulation (ESM) is regularly used successfully in clinical settings for the recovery of muscle tone in patients with orthopedic pathologies. In addition, it has already been used for Prehab, showing an increase in muscle strength and a decrease in postoperative hospital stay following knee arthroplasty. Also Exercise offers benefits in the treatment of orthopedic patients because improve: strength, cardiovascular fitness, functional capacities and quality of life. Therefore, in a group of patients who are candidates for elective lower limb arthroplasty surgery, it was decided to evaluate the effects of a Tele Prehab program, based on the ESM, and compare them with those of an Tele Prehab exercise program, equal in dose and duration. The proposal differs from those present in the literature for complete administration in telerehabilitation, including evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Elective Knee or Total Hip arthroplasty

Exclusion Criteria:

* concomitant orthopaedic or neurological pathologies (other than the pathology for which arthroplasty has been indicated) that modify the ability to walk;
* pathologies that modify the balance (neurological and/or vestibular);
* contraindications to the use of medical equipment used in the study;
* inability to understand and sign informed consent.
Quantitative C-Reactive Protein for Differentiating Tuberculous and Malignant Pleural Effusion: a Cross-Sectional Study

The goal of this observational study is to evaluate the role of pleural fluid Quantitative C-Reactive Protein (Q-CRP) levels in distinguishing between tuberculous and malignant pleural effusion in adult patients with lymphocytic exudative pleural effusion.

The main questions it aims to answer are:

Is pleural fluid Q-CRP significantly higher in tuberculous pleural effusion compared to malignant pleural effusion? What is the optimal cutoff value of pleural fluid Q-CRP to differentiate between these conditions?

Participants will:

Undergo diagnostic procedures such as pleural fluid analysis, including ADA and cytology.

Provide pleural fluid samples for Q-CRP measurement. Have additional diagnostic imaging or biopsies if clinically indicated.

Researchers will compare Q-CRP levels between the tuberculous pleural effusion group and the malignant pleural effusion group to determine its diagnostic accuracy, including sensitivity, specificity, and predictive value.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older.
* Patients presenting with lymphocytic exudative pleural effusion confirmed by Light's criteria.
* Lymphocyte predominance in pleural fluid (≥ 50% of differential count).

Exclusion Criteria:

* Patients who refuse to provide consent for study participation.
* Patients requiring biopsy under general anesthesia but found unfit for the procedure.
* Non-tuberculous and non-malignant lymphocytic exudative pleural effusions identified during diagnostic evaluation.
Evaluation of a Rehabilitation Program After Lung Surgery

Fast track programs, multimodal therapy strategies, have been introduced in many surgical fields to minimize postoperative morbidity and mortality. This study is intended to evaluate a rehabilitation program in comparison with a historical series.


Eligibility Criteria:
Inclusion Criteria:

* adult patient
* ASA 1, 2 or 3
* lung surgery (postero-lateral or axillary approach)
* epidural analgesia

Exclusion Criteria:

* preoperative oxygen therapy
* lack of autonomy
* unstable coronary artery disease
* FEV1 \< 50%
* pregnancy
Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy

As a supplement to the ongoing randomized evaluation of the Cognitive Behavioral Therapy (CBT) anxiety prevention intervention in Pakistan (R01-MH111859), the investigators propose to explore potential biological mechanisms (related to inflammation and endocrine functioning) of antenatal anxiety through additional data collection with 300 pregnant women.

This study will leverage the ongoing randomized evaluation of the CBT anxiety prevention intervention in Pakistan (R01-MH111859) to explore potential biological mechanisms. This CBT intervention targets both sub-threshold anxiety symptoms and generalized anxiety disorder (GAD) in early- to mid- pregnancy, aiming to both prevent and treat Common Mental Disorders (CMDs) (GAD and major depressive episodes (MDE)) as well as improve birth outcomes. The study team proposes to additionally study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), the study will also include 100 healthy women without anxiety or depression. The aims are to 1) characterize the "immune phenotype" of anxious women across the peripartum, specifically by measuring the relation among anxiety symptoms and peripheral markers of inflammation within and across women (both anxious and healthy) and between those receiving the intervention and control; 2) determine the relation between levels of allopregnanolone (ALLO) in pregnancy and concurrent anxiety symptoms and future symptoms of postpartum depression (PPD), 3) examine the relation between changes in immune functioning and ALLO levels in anxious pregnancy across time, 4) examine whether immune function and/or ALLO are mediators or moderators of the association between antenatal anxiety and preterm birth and/or small-for-gestational age, and 5) examine the effects of both anxiety and the intervention (including biomarkers) on infant development at six weeks postpartum.

Eligibility Criteria:
Inclusion Criteria:

* ability to understand spoken Urdu
* pregnant, ≤22 weeks' gestation
* age ≥18 years
* residence ≤20 km of Holy Family Hospital
* intent to reside in the study areas until the completion of the study

Exclusion Criteria:

* Current anemia
* Current major depressive episode (MDE on SCID) or life-threatening health conditions including e.g. active severe depression or suicidal ideation
* Self-report of past or current significant learning disability
* Self-report of past or current psychiatric disorder (e.g. bipolar disorder or schizophrenia) or psychiatric care (e.g. current use of anxiolytic drug and/or other psychotropic drug)
* medical disorders or severe maternal morbidity that require inpatient management that would preclude participation (101)
* ICU admission indicated by diagnosis (not only for assessment)
Compare the Outcomes of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus WALANT

Comparison between results of repair of cut flexor zone II under General anesthesia and Walant

Cut Flexor is common injury ,has unique characters as they cannot heal without surgical treatment, unique anatomy of the tendons running through flexor tendon sheaths to function and postoperative management \&mobilization to prevent adhesions and improve gliding but risk of rupture.

The hand is divided into five zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to 14th century (area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding of flexor tendon anatomy, biomechanics , and healing new techniques of surgery and anesthesia repair is possible with good results.

General anesthesia has been the standard technique for along time. wide awake local anesthesia no tourniquet. (WALANT),using safe drugs lidocaine for anesthesia and epinephrine for hemostasis, the investigators can do operations while patient is awake.

WALANT has been recommended by some surgeons to be the next standard for repair of zone 2 injuries .

This techniques has a lot of Advantages in repair zone II as 1) intraoperative testing of the flexor repair by active movement to exclude any gap. and lets the surgeon see that the repair fits through the pulleys with active movement.

2)sheath and pulley damage are minimized, as flexor tendons are repaired through small transverse sheathotomy incisions 3) the surgeon can interview the patient during the procedure and assess the ability to comply with the postoperative regimen 4) the risks of general anesthesia are avoided in most patients. Negative effects of general anesthesia include nausea and vomiting, hospital admission for anesthesia recovery, exacerbation of comorbidity issues such as diabetes, aggressive flexion by the patient emerging from general anesthesia,and others

Eligibility Criteria:
Inclusion Criteria:

* Acute zone II flexor tendon injuries of the hand in both genders in medial four fingers.
* Cooperative patients aged between 16-60 years.
* Sharp mechanism of injury
* Single level injury

Exclusion Criteria:

* Age less than sixteen years old or more than sixty years old .
* Associated fractures close to the tendon injury.
* Vascular injury requiring revascularization
* Multiple level injury
* Combined flexor and extensor laceration
* Insufficient skin and soft tissue coverage
* Tendon substance loss