cyrilzakka/clinical-trials huggingface dataset:
Development and Internal Validation of Predicting Models of Idiopathic Scoliosis Natural History and Treatment Outcomes Through the Use of Artificial Intelligence in a Large Clinical Database

Scoliosis is a three-dimensional deformity of the spine. In its most common form (about 70% of cases), the causes are unknown, therefore it is called idiopathic scoliosis. In most cases, it is discovered after 10 years of age, and is defined diagnostically as a curve of at least 10°, measured on a standing x-ray using the Cobb method.

If scoliosis exceeds the critical threshold of 30° Cobb at the end of growth, there is a progressively greater risk of health and social problems in adult life. For this reason, the main aim of the treatment is to complete the growth period with a curve less than 30° and good sagittal balance, or at least well below 50°, which represents the surgical threshold.

Growth is a factor favouring the evolution of deformities, therefore patients are followed until the end of growth. This is why therapy can last many years, from the discovery of the presence of a deformity until bone maturation is achieved.

The early identification of parameters predictive of the outcome of the therapy to direct the least possible aggressiveness towards the result necessary for the patient's future, integrated with the evaluation of its effectiveness (monitoring), is one of the most important objectives in this field to minimize the burden of treatment in a particular phase of growth such as adolescent development, as well as to identify the subjects most at risk of worsening in adulthood.

The systematic collection of clinical data during the therapeutic process offers the possibility, through advanced analysis models, applied retrospectively, to identify predisposing factors and protective factors. When the data available is sufficiently large, it is possible to obtain predictive equations that assist clinicians in therapeutic choices and help patients understand the risks and benefits of available therapies. New technologies such as artificial intelligence techniques offer new and interesting ways of estimating risks and calculating the benefits and safety of some therapeutic choices compared to others.

This study aims to develop and internally validate data-driven stratification and prediction models to predict multiple end-of-care outcome measures that include curve magnitude, measured in Cobb degrees, measures determining the sagittal balance, and measures of quality of life and function measured through self-completion questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic scoliosis
* \< 20 year old

Exclusion Criteria:

* Secondary scoliosis
* history of scoliosis corrective surgery
* history of pathologies affecting the spine that can affect the result or spine trauma
* Iatrogenic scoliosis
Lignocaine Versus Sodium Bicarbonate on Reducing Pain During Propofol Injection

To compare the effect of adding lignocaine and sodium bicarbonate to propofol in reducing pain on propofol injection (POPI).

Propofol is the most commonly used intravenous (IV) anesthetic drug for induction of anesthesia and for sedation. It is almost an ideal IV anesthetic agent, but pain which occur during its injection still remains a problem. This pain may not be a serious complication, but most patients remember it as an unpleasant encounter with anesthetists. In one survey, pain on propofol injection (POPI) stands 7th most important problem in the current practice of anesthesia . About 70 to 90% of patients who were given propofol for anesthesia induction experience pain during injection and this pain can be quite severe. All phenols irritate skin and mucous membranes. Thus, propofol being an alkyl-phenol is expected to induce pain despite the fact that it is almost isotonic. POPI has also been described as angialgia which means that the pain is due to vascular involvement . POPI is immediate as well as delayed after 10-20 seconds . The immediate pain is due to irritation of vein endothelium while as delayed pain is due to the release of mediators such a kininogen from kinin cascade . The most frequently used drug to alleviate POPI is intravenous lignocaine. The use of lignocaine to decrease POPI is due to its local anesthetic effect on the veins. However, it does not alleviate pain effectively in about 40% of the patients treated in this way (2). Administration of sodium bicarbonate was proved to reduce POPI. The proposed mechanism is through increasing sodium ions concentration as well as increasing serum pH through its buffering effect.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 65 years old.
* Patients classified as ASA I or II.

Exclusion Criteria:

* Patients with the history of allergy to propofol or lignocaine.
* Patients took any medication for analgesia or sedation in the past 24 hours.
* Body mass index (BMI) more than 30.
* Patients classified as ASA III \& IV.
* Severe mental illness.
Lifestyle Intervention for Obstructive Sleep Apnea in Women

Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition.


Eligibility Criteria:
Inclusion Criteria:

* Previous clinical diagnosis of moderate/severe OSA (AHI \> 15)
* Female patients aged between 18-65 years.
* Body mass index \> 25 kg/m2.
* Use of CPAP.
* Motivation to participate in the study.
* Signed informed consent form.

Exclusion Criteria:

* Sleep disorder other than OSA.
* Clinically significant psychiatric, neurological, or medical disorders other than OSA.
* Use of prescription drugs or clinically significant drugs affecting sleep.
Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD）

The purpose of this study is to assess the efficacy and safety of HSK31679 tablets compared with placebo in reducing low-density lipoprotein cholesterol (LDL-C) and MRI-PDFF after 12 weeks of treatment in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD).


Eligibility Criteria:
Inclusion Criteria:

1. Must be willing to participate in the study and provide written informed consent.
2. Male or female aged 18 ≤ age \< 65 at the time of signing the informed consent.
3. At the time of screening, patients who had not received lipid-regulation therapy within 6 weeks had fasting LDL-C≥3.34mmol/L（130mg/dL）.
4. (BMI) ≥18kg/m2 and female subjects ≥45.0 kg and male subjects ≥50.0 kg.
5. During screening, fasting triglyceride (TG) \<5.65 mmol/L.
6. During screening,MRI-PDFF≥8%.
7. Weight changes≤5% in the 4 weeks prior to screening.

Exclusion Criteria:

1. Did not discontinue any lipid-regulating therapy or any drug or supplement that may affect lipid levels 6 weeks before randomization or is expected to do so during the study period.
2. Homozygous familial hypercholesterolemia (HoFH) was diagnosed by genetic or clinical criteria.
3. Dyslipidemia caused by other diseases or drugs, such as rheumatoid arthritis, nephrotic syndrome, Cushing's syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen accumulation, myeloma, lipodystrophy, acute porphyria, polycystic ovarian syndrome, etc
4. Before screening, LDL-C plasma exchange was performed within 12 months.
5. In the past, PCSK9 inhibitors, Lomitapide and Mipomersen were used for treatment.
6. uncontrolled hypertension had systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg at screening/baseline.
7. type 1 diabetes, or newly diagnosed type 2 diabetes within 1 month, or poorly controlled type 2 diabetes, or who could not maintain the same hypoglycemic regimen during the study.
8. Stroke or transient ischemic attack (TIA), acute coronary syndrome, stable angina attack, severe deep vein thrombosis, or pulmonary embolism occurred in the 12 months prior to screening.
9. Major surgery (including but not limited to: coronary or other revascularization, coronary artery bypass surgery, and transplantation) within 12 months prior to screening or planned during the study period.
10. Chronic systemic disease or history, including but not limited to

    1. Have a serious cardiopulmonary disease or history,Neurological disease or history,Autoimmune disease,Chronic digestive disease or history
    2. Have thyroid disease or symptomatic abnormalities in thyroid function tests (e.g., thyroid stimulating hormone (TSH) \< 1.0 x lower limit of normal (LLN) or \> 1.5 x upper limit of normal (ULN))
    3. History of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening
    4. Disease or medical history assessed by the investigator as likely to affect the study
11. Bariatric surgery within 12 months at the time of screening
Survey of Inhibitors in Plasma-Product Exposed Toddlers

The primary objective of the study is to assess the immunogenicity of VWF/FVIII and of rFVIII concentrates by determining the frequency of inhibitor development in previously untreated patients (PUPs) or minimally blood component-treated (MBCTPs) in the first 50 EDs or in the first 3 years from enrollment, whichever occurs first.

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Patients meeting the enrollment criteria will be consecutively enrolled at each participating centre, randomized to be treated exclusively with a single FVIII product either plasma-derived or recombinant, and followed up until inhibitor development or until 50 exposure days (EDs) or 3 years from enrolment have elapsed, whichever comes first. Study products, belonging to the class of rFVIII concentrates and to the class of plasma-derived VWF/FVIII concentrates, will be provided for free to the patients for all the duration of the study

Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Any ethnicity
* Age \<6 years
* Severe haemophilia A (FVIII:C \<1%), as confirmed at enrolment by the central laboratory.

  o Those patients diagnosed locally as severe but subsequently found to have FVIII levels \>= 1% on testing at the central laboratory will be separately recorded in the screening list.
* Previously untreated (0 EDs to any FVIII concentrates or blood products) or minimally treated (\<5 EDs) with blood components, namely whole blood, fresh frozen plasma, packed red blood cells, platelets or cryoprecipitate.

  o Patients not meeting these criteria will be separately recorded in the screening list.
* Negative inhibitor measurement at both local and central laboratory at screening
* Ability to comply with study requirements
* Signed informed consent of legal tutors o Patients who will not accept to enter into the study or to be randomized will be separately recorded.

Exclusion Criteria:

* Previous history of FVIII inhibitor
* Other congenital or acquired bleeding defects
* Plasma FVIII level \>= 1%, as assayed at the central laboratory

  o Those patients originally diagnosed locally as severe but subsequently found to have FVIII levels ranging from 1% to 2% on testing at the central laboratory will be separately recorded in the screening list.
* Concomitant congenital or acquired immunodeficiency
* Concomitant treatment with systemic immunosuppressive drugs
* Concomitant treatment with any investigational drug
Descemet Endothelial Thickness Comparison Trial II

Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.


Eligibility Criteria:
Inclusion Criteria:

* Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
* Peripheral endothelial cell count \>1000 cells/mm2 in at least one quadrant
* Good surgical candidate for either procedure as determined by the surgeon
* Willingness to participate
* Age greater than 18 years

Exclusion Criteria:

* Aphakia, anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK
* Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
* Other primary endothelial dysfunction such as PPMD
* Visually significant optic nerve or macular pathology
* Hypotony (Intraocular pressure \<10mmHg)
* Any prior intraocular surgery other than cataract surgery
* \>3 clock hours of ANY anterior or posterior synechiae
* \>1 quadrant of stromal corneal vascularization
* Inability to comply with post-operative instructions (i.e. unable to position)
* Pregnancy
Comparison of Propioceptive Neuromuscular Facilitation Vs Balance Exercise Along With Conventional Therapy for Balance and Gait in Chronic Parkinson's Patient

To determine the effect of Proprioceptive Neuromuscular Facilitation Vs Balance Exercise along with Conventional Therapy for balance and gait in Chronic Parkinson's patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Parkinson's patients.(34)
* Patients from both gender around the age of 45-65.(35)
* Patient with a score of 42 above on the Berg Balance Scale.(29)
* Patient with good cognitive function minimum score of 20 or more on Mini-mental Status Examination Scale (MMSE).(36)

Exclusion Criteria:

* Patients with a history of recurrent stroke.(37)
* Patient with peripheral vascular disease.(38)
* Patient with fracture or dislocation of lower limb.(39)
* Patient with peripheral nerve injury.(40)
* Patient with skin discoloration, skin ulcers, and skin allergy.(41)
Predicting 28-Day Mortality in Subarachnoid Hemorrhage

The investigators investigated the predictive ability of clinical and radiological scores, including the Glasgow coma scale (GCS), Hunt-Hess, World Federation of Neurological Surgeons (WFNS), and modified Fisher scales, as well as combined clinical scores such as the VASOGRADE and Ogilvy-Carter rating scales, for 28-day mortality in patients presenting to the emergency department (ED) with non-traumatic subarachnoid hemorrhage (SAH). Specifically, we tested the hypothesis that combined clinical scores are more reliable and superior to non-combined clinical and radiological scores in predicting 28-day mortality in non-traumatic SAH.

Patients were divided into survivors and non-survivors, with surviving patients further categorized as either mobile or immobile based on the Glasgow outcome scale. Accordingly, patients who were dependent on daily support or in a coma were classified as immobile, whereas patients who had returned to normal life or were independent in their daily activities were classified as mobile. The demographic (age and sex), comorbidities (hypertension, diabetes mellitus \[DM\] and/or coronary artery disease \[CAD\]), vital signs (systolic blood pressure, heart rate, respiratory rate, and peripheral capillary oxygen saturation \[sPO2\]), and clinical assessment tools (GCS, Hunt Hess, WFNS, modified Fisher, VASOGRADE, and Ogilvy-Carter rating scales) on admission were compared between the groups to identify factors associated with 28-day mortality and neurological survival. Independent predictors of mortality were determined by multivariate logistic regression analysis of variables (demographic characteristics, clinical characteristics, and trauma scores) that differed significantly between survivors and non-survivors. An area under the curve (AUC) analysis was then conducted to identify which trauma score is the most reliable and superior predictor of mortality.

Eligibility Criteria:
Inclusion Criteria:

* patients (aged ≥ 18 years) who presented to the emergency department with non-traumatic Subarachnoid Hemorrhage between September 2020 and September 2023

Exclusion Criteria:

* patients younger than 18 years
* patients with missing information
* patients with traumatic SAH
* patients with subdural or epidural hemorrhage
* patients with concurrent ischemic stroke
Linear Growth Study (0476-097)(COMPLETED)

The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.


Eligibility Criteria:
Inclusion Criteria :

* Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty)
* Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty
* With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists)

Exclusion Criteria :

* Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1
The Effects of Surgery Performed At Different Times of the Day on Inflammation and Recovery

To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). The main question it aims to answer is; Is the inflammation response higher in participants who undergo surgery later in the day? Serum inflammatory parameters will be measured in both groups at the preoperative 1st hour and the postoperative 24th hour.

Participants who would undergo unilateral inguinal herniography surgery at different times during the day were determined into two groups: day (08.00-12.00) and night (18.00-22.00). The Athens Insomnia Scale (AIS) will be asked verbally on the first preoperative day to determine the participants' preoperative circadian rhythm adaptation and sleep status. Serum inflammatory parameters of both participant groups will be measured and recorded at the preoperative 1st hour and the postoperative 24th hour. A laryngeal mask will be applied to the participants after induction with 2-3 mg/kg propofol and 1mg/kg fentanyl, as in routine anesthesia practice. Anesthesia maintenance will be provided with sevoflurane and 0.05-0.2 mcg/kg/min remifentanil infusion. Participants' age, gender, weight, height, BMI (body mass index), comorbidities, medications used, surgeries, ASA (American society of anesthesiologists) scoring, preoperative AIS (Athens insomnia scale) score, and preoperative laboratory data will be recorded. At the same time, participants' postoperative hospital stay, resting and moving NRS (Numeric rating scale) scores at the 24th postoperative hour, and recovery quality (Qor-15 score) from anesthesia will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American society of anesthesiologists) 1-2 adult participants between the ages of 18-70 who will undergo unilateral inguinal herniorrhaphy surgery at the Republic of Turkey Ministry of Health Ankara City Hospital.

Exclusion Criteria:

* Do not want to participate in the study
* Younger than 18 or older than 70
* Scores 6 and above on the preoperative Athens Insomnia Scale.
* ASA (American society of anesthesiologists) scores of 3 or greater than 3
* Have contraindications to the use of anesthetic drugs
* BMI\>30 kg/m\^2
* Have bilateral herniorrhaphy surgery
* Complicated inguinal hernia (incarcerated, strangulated...)
* Pregnancy
* Emergency surgeries
* Laparoscopic surgeries
* Develop an unexpected intraoperative surgical complication
Adjunctive Treatment for Decreasing Symptoms of Schizophrenia

This study will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia.

A double-blind, placebo controlled clinical trial to examine whether adjunctive treatment with glycine or d-cycloserine, compared to placebo, will improve negative symptoms and cognitive impairments in patients with schizophrenia who remain on their normal antipsychotic regimen.

Multicenter, randomized, double-blinded placebo controlled parallel-groups clinical trial designed to test the hypothesis that interventions (glycine or d-cycloserine) intended to increase glutamatergic activity by action at the NMDA receptor will reduce persistant negative symptoms and cognitive impairments of patients with schizophrenia or schizoaffective disorder. After an initial screening phase to establish clinical stability and eligibility, patients were assigned to one of three adjunctive treatments (placebo, d-cycloserine or glycine)for 16 weeks of double-blind treatment. Patients remained on a stable dose of antipsychotic therapy (other than clozapine) throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder
* stable, enduring negative symptoms above a certain level (SANS \>19)
* clinically stable, with psychotic symptoms measured on BPRS below 19, anxiety/depression on BPRS below 15
* extrapyramidal symptoms measured on SAS below 9
* on stable antipsychotic regimen (not including clozapine)

Exclusion Criteria:

* alcohol or substance dependence within last six months
* alcohol or substance abuse within last month
* organic brain disorder
* medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia, including active tuberculosis or tuberculosis treatment, kidney stones, and uncontrolled diabetes mellitus
* Female participants could not be pregnant and were required to be using a documented method of contraception.
A Comparative Study of Platelet-Rich Plasma and Normal Saline Dressings in the Treatment of Chronic Wounds (PRP-NS Wound T)

This study aims to compare the effectiveness of Platelet-Rich Plasma (PRP) dressings versus Normal Saline dressings in the treatment of chronic wounds. Chronic wounds are slow-healing wounds that can cause significant discomfort, increase the risk of infections, and impact a patient's quality of life.

Platelet-Rich Plasma (PRP) is derived from the patient's own blood and contains growth factors that may help promote faster wound healing. On the other hand, Normal Saline dressings are commonly used as a standard wound care approach.

Participants in this study will be randomly assigned to receive either PRP dressings or normal saline dressings. The healing progress of their wounds will be monitored over a specified period to determine which treatment leads to better and faster healing.

The findings from this study may help improve wound care management and provide evidence for using PRP as an effective treatment for chronic wounds.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-60 years of either gender were included if they had a chronic wound persisting for at least six weeks and with a size of at least 2 × 2 cm.

Exclusion Criteria:

* Patients were excluded if their wounds had existed for less than six weeks, if they had a previous history of PRP dressing use, or if they had documented hypersensitivity to PRP.