cyrilzakka/clinical-trials huggingface dataset:
A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid Tumors

This clinical research study is being conducted to investigate the effectiveness of combining carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory solid tumors.


Eligibility Criteria:
* children 1-21 years of age
* confirmed diagnosis of measurable solid tumor, including brain tumor, which has progressed on or after standard therapy, or for which no effective standard therapy is known
* at least 4 weeks since last dose of immunotherapy, radiotherapy, or chemotherapy
* no more than 3 prior chemotherapies
* no symptomatic brain metastases
The Norwegian Physical Therapy Study in Preterm Infants

This is a pragmatic randomized controlled study. The purpose of the study is to evaluate the practice and effect of customised physiotherapy on preterm infants'motor development when the intervention is performed over a period of three weeks while the infant resides in the neonatal intensive care unit. The study will also attempt to analyze the parents' experiences in being actively involved in education and practice of the intervention designed to promote the child's motor development, and the effects on the parent-child relationship in the short and long term.The children are followed up until a corrected age of two years. This study consists of a pragmatic randomized controlled trial and a qualitative study.

Infants born preterm with an gestational age below 32 weeks have an increased risk of developing different grades and types of abnormalities, among them delayed motor development, co-ordination difficulties and cerebral palsy. The prevalence of serious developmental abnormalities increases the lower the gestational age and birth weight. The reported incidence of mild developmental abnormalities is 15-20 % in children with a gestational age \<28 weeks or with a birth weight under 1000 g, 10-20 % in children with a gestational age of 28-31 weeks or a birth weight between 1000-1500 g and only 5 % in children born at term. The incidence of cerebral palsy is 10-20% amongst children in the first group, 5-10% in the second group and only 0,1 % in children born at term.With such a high risk of developing motor abnormalities for infants born preterm together with limited evidence-based knowledge of early physiotherapy approaches that facilitate motor development, it is essential that more research is done in this area to ensure that physiotherapy if used, is in the right manner to prevent and reduce such difficulties.

Eligibility Criteria:
Inclusion Criteria:

* Child born before or at 32nd gestational week.
* Child that tolerates being handled at 34th week postmenstrual age.
* Parents that can perform the intervention understand and speak Norwegian.
* Follow up of the child in the hospital where the intervention is given.

Exclusion Criteria:

* Child born later than 32nd week.
* Child who cannot tolerate being handled for up to 10 minutes at 34th postmenstrual age.
* Triplets or more.
* Child who has undergone surgery.
* Child with large deformities.
* Parents that can perform the intervention but do not understand and speak Norwegian.
* Follow up of the child is not taking place in the hospital where the intervention is given.
* All children who fill the inclusion criteria will be included to begin with.
* If at a later stage they are unable to manage the tests due to their condition they will be excluded.
Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis

The aim of this study was to investigate the efficacy and safety of three weekly intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle Osteoarthritis (OA).

Viscosupplementation with 3 to 5 weekly hyaluronate injections is a well-established treatment option in knee osteoarthritis. Previous studies reported that five weekly hyaluronate injections were safe and effective for the treatment of ankle osteoarthritis. However, the effect of three weekly injections has rarely been investigated. Besides, no study to date has assessed whether balance function would change after HA injections in patients with ankle OA. The purpose of this study was to evaluate the efficacy and safety of three weekly injections of sodium hyaluronate (Hyalgan) in patients with unilateral ankle osteoarthritis. Pain, physical function and balance will be assessed as parameters for the effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* were 18 years of age or older, reported unilateral ankle pain for at least 6 months and had either reported no significant benefit from conservative treatment (rest, physical therapy, orthoses or pain medications etc.) or were unable to tolerate side effects of medications
* ankle radiographs taken within 6 months were equivalent to grade 2 or 3 according to the Kellgren-Lawrence grading system (grade 2, definite osteophytes and possible narrowing of joint space; grade 3, moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour)22
* had a current total AOS score (described below) of \> 3 and \< 9 (possible range, 0-10)
* were normally active, not bedridden or confined to a wheelchair, and were able to walk 30 meters without the aid of a walker, crutches or cane
* were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (except for rescue medication) for the duration of the study
* did not receive physical therapy or trial of shoe modifications or orthotics during the study period

Exclusion Criteria:

* pregnant and lactating women
* bilateral ankle OA requiring treatment of both ankles
* chronic ankle instability
* lower leg trauma other than within the ankle
* previous orthopedic surgery on the spine, hip or knee
* presence of active joint infections of foot or ankle
* previous surgery or arthroscopy on the ankle within 12 months
* intraarticular steroid or HA injection in the treated ankle within the past 6 months
* treatment with anticoagulants or immunosuppressives
* history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
* history of avian protein allergy
* presence of other comorbidity (neoplasm, diabetes mellitus, paresis, recent trauma, etc) or poor health status that would interfere with the clinical assessments during the study
Obstetric Comorbidity Index in Postpartum Hemorrhage

The objective of this study is to examine the predictive capability of the Obstetric comorbidity index in the identification of severe maternal morbidity associated with postpartum hemorrhage in patients undergoing cesarean delivery.

The prospectively predictive maternal morbidity is imperative to enhance maternal outcomes. There has been development of the obstetric comorbidity index (OBCMI) by Bateman et al. in 2013 and performed with superior performance characteristics relative to general comorbidity measures in an obstetric population. The score has been a growing recognition of the necessity for specialized risk assessment tools tailored specifically to obstetric populations that differ from other populations. For instance, both the Charlson/Romano comorbidity index or the Elixhauser comorbidity score and their adaptations are deficient in accounting for obstetric conditions, thereby limiting their ability to predict obstetric morbidity or mortality.

The Obstetric Comorbidity Index has undergone thorough examination and validation across multiple nations. These findings collectively demonstrate the index's capacity for moderate to high predictive accuracy in anticipating maternal morbidities, accompanied by a commendable discriminative performance.

However, within the context of Thailand, investigations concerning the Obstetric Comorbidity Index and its association with perioperative complications or morbidities in postpartum hemorrhage patients undergoing cesarean delivery remain unexplored. Therefore, this study aims to elucidate the correlation between the Obstetric Comorbidity Index and severe maternal morbidity, while also scrutinizing the prevalence of comorbidities during the perioperative period among patients undergoing cesarean delivery at the largest University hospital, in THAILAND. Predicting the rate of maternal morbidity would be advantageous for facilitating preparation and augmenting awareness of complications during the perioperative period.

Eligibility Criteria:
Inclusion Criteria:

The patients underwent cesarean delivery with the diagnosis of postpartum hemorrhage (ICD-10 coding O72.1)

Exclusion Criteria:

* Cesarean delivery at less than 24 weeks of gestation
* A patient chart that does not contain primary outcome data eg. absence of anesthetic record
* Blood loss less than 1,000 ml in the first 24 hours postpartum
Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy

The study is designed as non interventional to collect data on the effectiveness of acarbose and metformin monotherapy, respectively, in terms of change from baseline in post prandial blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each carbohydrates consumption subgroup under real-life treatment condition in large sample of type-2 diabetes patients in India. The study will begin after the study approval by ethics committee.All drug naïve patients in whom decision to administer acarbose or metformin monotherapy for type 2 diabetes management has been made will be included in study after taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll 12250 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Drug-naïve (i.e., the patients should never be treated with anti-diabetic drugs before screening) patients in whom decision to administer monotherapy with either acarbose or metformin for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and medical patient needs, and who consent to participate in study will be included

Exclusion Criteria:

* Patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded. However, during observation period, patients may receive any additional anti-diabetics medication at the decision of investigator.
* Exclusion criteria should be read in conjunction with local product information. All contra-indications according to the local marketing authorization should be considered
Pharmacokinetic Study for PCA Derivate Formulations

A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the informed consent process culminating with written informed consent by the subject.
* Males
* Age 18-45 years
* Abstinence from alcohol for 1 week prior to the study
* Non smoking
* BMI \> 19 and \< 30
* No history or evidence of significant

  * cardiovascular,
  * hepatic,
  * renal,
  * hematopoietic,
  * gastrointestinal disease,
  * endocrine,
  * metabolic,
  * psychiatric
  * psychological disorders
* Normal physical examination
* Within +/- 10% of normal values in laboratory examinations

Exclusion Criteria:

* Subjects who suffer from a current medical condition.
* Subjects who smoke.
* Subjects who drink \> 20 grams of alcohol per day.
* Subjects who take prescription medication.
* Subjects with an abnormality in screening blood tests
* Known sensitivity to any ingredients in the study drug
Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus

Keratoconus is a symmetrical, bilateral, non-inflammatory, idiopathic corneal pathology, characterized by a progressive corneal thinning. This disease leads to a bombing of the cornea, inducing a strong corneal astigmatism, responsible for a loss of visual acuity sometimes very important, non-correctable by lens of glasses. Collagen Cross-Linking (CXL) and simple corneal de-epithelization are two common surgical technics aiming to slow the progression of this pathology. They consist in rigidifying the corneal structure in order to stabilize its deformation progression. Even though these technics are commonly performed, none of these strategies has proven their efficiency. The effects of CXL can be due to the superficial scarring reaction as well as the effects of corneal remodeling induced by the de-epithelization phase during a CXL procedure, and not due to the covalent links between collagen and fibrils, formed by the biochemical reaction resulting from the UV-A exposition in the presence of Riboflavine De-epithelization may be an equally effective treatment, when compared to CXL, but without long term secondary effects. Its association with a therapeutic photokeratectomy (PKT, surgical technic used to regulate the corneal surface, and eliminate its opacities in order to recuperate the transparency of the cornea) will aim to improve the regularity of the anterior corneal surface, thus allowing a better epithelial attachment (adhesion) and may allow a stromal inflammatory reaction, favorable to the improvement of corneal biomechanics. PKT is a reliable technic; however it has not yet proven its efficiency in the treatment of keratoconus.

The purpose of this study is to describe the effects of de-epithelization associated with a therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the proportion of patients who lost the evolutivity of their keratoconus, after 6 months and 1 year, after an intervention of de-epithelization associated with therapeutic photokeratectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 15 to 45 years old
* Patients with an evolutive keratoconus
* Planned intervention (de-epithelization and photokeratectomy)

Exclusion Criteria:

* Contra-indication to de-epithelization (active scarring corneal lesion)
* Pregnant women and breastfeeding
* Absence of the written consent to participate in the trial
Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From HIRA Database

The goal of this observational study is to compare severity and mortality rates of acute cerebral infarction(requiring thrombolysis or endovascular recanalization) depending on the type of oral antidiabetic drug taken before the onset of cerebral infarction.

Researchers will compare the group that used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction and the group that did not use them to see the effect of DPP-4 inhibitors in reducing severity of cerebral infarction.

This is a retrospective study to see the effects of reducing the severity of cerebral infarction(requiring thrombolysis or endovascular recanalization) of DPP-4 inhibitors by comparing the survival rate after acute cerebral infarction hospitalization, discharge rate to home, and medical cost.

A. Severity of cerebral infarction and poor prognosis is mainly associated with hyperglycemia caused by diabetes, which increases the Infarction volume and hemorrhagic trasformation.

B. However, the effect of loergin blood glucose on reducing the Infarction volume and improving prognosis of cerebral infarction has not been proven.

C. Preclinical studies have demonstrated a anti-stroke effect that reduces the Infarction volume using certain anti-diabetic drugs.

D. Therefore, there is a possibility that certain anti-diabetic drugs may reduce the severity of cerebral infarction as a class effect in addition to the effect of blood sugar control.

E. This is particularly likely to exist in the DPP-4 inhibitor family identified through preclinical studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute cerebral infarction who underwent thrombolysis or endovascular recanalization in Korea between 2014 and 2021
* Those who have been previously diagnosed with diabetes and are taking oral anti-diabetic drugs
* Adult (over 19 years of age)

  * The definition of antidiabetic drug use is defined as a case in which an antidiabetic drug was prescribed for at least 2 months before stroke and the duration of treatment for stroke coincided with the prescribed duration of the drug.

Exclusion Criteria:

* Patients taking insulin to control diabetes
Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast

The investigators will evaluate the analgesic efficacy of pulsed radiofrequency on the thoracic paravertebral nerves for patients with chronic mastalgia of fibrocystic disease of the breast


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic mastalgia due to fibrocystic disease of the breast
* the pain duration maintained for more than 1 year
* the pain intensity is more than 5 on VAS pain score

Exclusion Criteria:

* coagulopathy
* infection at the site of the procedure
CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation

A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.


Eligibility Criteria:
Inclusion Criteria:

1. Age 45 years or more
2. Spectacle or soft contact lens wearer
3. Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D
4. Best spectacle corrected visual acuity of 6/9 or better in each eye
5. Willingness to adhere to the instructions set forth in the clinical protocol
6. Signature of the subject Informed Consent form after review of Information to Participant document.

Exclusion Criteria:

1. Systemic or ocular allergies which might interfere with contact lens wear
2. Systemic disease which might interfere with contact lens wear
3. Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)
4. Use of medication which might interfere with contact lens wear
5. Active ocular infection
6. Use of ocular medication
7. Significant ocular anomaly
8. Presence of two or more corneal scars in either eye
9. Monovision contact lens wearers
10. Pregnancy or lactation
11. Any medical condition that might be prejudicial to the study
12. Participants non-able to give consent or from a vulnerable group
13. Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.)
14. Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)
The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females

This Study is focused on the interaction between resting metabolic rate (RMR), physical activity (PA), and thyroid hormones (TH). TH controls almost all the cell activities of the body so, it is known as one of the major regulatory hormones. This is the reason for individuals who suffer from thyroid disorders show abnormal metabolism. Recently it was suggested that interindividual variations in thyroid hormone levels also influence daily physical activity.

In this study, investigators will recruit adult females with a BMI ≥18.5. After the screening process, eligible volunteers will undergo certain measurements including body composition, resting metabolism daily physical activity, thyroid hormone levels, and total energy expenditure. The investigators will access the changes in resting metabolism and daily physical activities with the differences in thyroid hormone levels.

Eligibility Criteria:
Inclusion Criteria:

* Female age ≥18;
* BMI≥18.5

Exclusion Criteria:

* Intended weight change exceeding 2kg within the past three months;
* Having any special medical diets or having eating disorders;
* Pregnant women or breastfeeding women;
* People who have metal implants in their bodies;
* Patients with metabolic diseases, infectious diseases, and genetic disorders such as hypothyroidism, and hyperthyroidism;
* Patients with a personal or family history of medullary thyroid carcinoma (MTC), or patients with rare type 2 multiple endocrine tumor syndrome (MEN2); People with a fear of needles (Trypanophobia), claustrophobia; People who are fear of blood (Hemophobia) or pathological hypotension;
Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage

A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine which is supposed to mimic the chest percussion performed by professional physiotherapist to mobilize sputum through the respiratory passage.

The aim of this study is to compare the effectiveness and safety of this mechanical percussion device in the treatment of airway clearance with conventional chest physiotherapy carried out by qualified physiotherapists in patients suffering from bronchiectasis or Chronic obstructive Pulmonary disease (COPD).

This study will compare the amount of sputum expectorated during the two procedures and not intended to look at the clinical improvement of the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients \> 18 years of age
2. Chronic sputum expectoration-(producing \>30ml/day of sputum at baseline)
3. Clinical diagnosis of bronchiectasis or COPD
4. Not carrying out regular chest physiotherapy (for the purposes of this study this will be defined as less than two occasions per week)
5. Clinically stable disease (defined as no requirement for antibiotics in the 4 weeks preceding study entry).
6. FEV1 of \> 35% of the predicted value in COPD patients

Exclusion Criteria:

1. Primary diagnosis of asthma;
2. Active sarcoidosis
3. Active Pulmonary tuberculosis.
4. History of brittle bones,
5. History of broken ribs in the past one year.
6. History of severe osteoporosis
7. Bleeding from the lungs or haemoptysis
8. Experiencing intense pain in the thoracic region
9. Clinical suspicion of increased intracranial pressure.
10. Have head or neck injuries
11. Have collapsed lungs or a damaged chest wall;
12. Recent myocardial infarction, unstable angina and stroke (Within 6 months prior to enrollment)
13. Have a pulmonary embolism or lung abscess;
14. Have an active hemorrhage
15. Have injuries to the spine
16. Have open wounds or burns in the thoracic region
17. Have had recent surgery (Within six months prior to enrollment.)
18. Any systemic steroids within 4/52 prior to enrollment
19. Any antibiotics within 4/52 prior to enrollment
Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome

There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved.

If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19.

However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the intensive care unit for SARS-CoV-2 ARDS
* Under controlled invasive ventilation for less than 7 days

Exclusion Criteria:

* Pneumothorax
* Deformation of the rib cage
* Contraindication to Electrical Impedance Tomography
* Pregnant or breastfeeding woman