cyrilzakka/clinical-trials huggingface dataset:
Fever Observational Study

To inform the feasibility of conducting a study to test different temperature thresholds at which clinicians deliver interventions to reduce fever (i.e. antipyretic interventions) in critically ill children with fever due to infection.

Fever (high temperature) is a normal bodily response to an infection, which has shown to have a beneficial effect in humans with chickenpox, malaria and rhinovirus infections. In children it has been recommended by the National Institute for Health and Care Excellence not to cool down the child using drugs or physical methods such as a cooling mat, with the sole aim to reducing the child's temperature. However, this recommendation is not aimed at the management of critically ill children, to which there is uncertainty around use of cooling interventions when considering the advantages of a fever in defending the body against viruses and bacteria during critical illness, and weighing that up with the possible negative physiological consequences of a high fever e.g. increased metabolic rate.

Observational studies show that the treatment of fever in critically ill children is inconsistent. There is a lack of robust data to guide antipyretic intervention, with clinicians usually starting fever management at around 37.5°C. Evidence is emerging that fever may be beneficial in critically ill adults. Due to the physiological differences between adults and children there is an important need to evaluate whether a different approach to fever management in critically ill children may also be beneficial.

Prior to conducting a large, expensive, randomised clinical trial (RCT) to evaluate whether a higher temperature threshold in starting treatments to cool down the child would be beneficial, we are conducting three studies to know if it is possible for us to test key outcome measures as a result of testing different temperatures thresholds for antipyretic management.

The Fever Observational Study is one of these studies, with the aim of identifying: the potential population that would be eligible for the proposed definitive trial, current temperature threshold(s) for fever management, and to describe the characteristics of outcome measures with the intention of deciding on a main measure to see which treatment method was more successful.

Eligibility Criteria:
Inclusion Criteria:

unplanned PICU admission referral requiring PICU admission to a participating unit
Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.

This study is being conducted to assess the safety and effectiveness of photochemically induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and Ecstasia.

Riboflavin drops are used every 2 minutes for 30+ minutes until the corneal stroma is saturated with Riboflavin as evidenced by observing Riboflavin in the Anterior chamber. Two arms in the study, one uses Riboflavin with Epithelium on and the other with Epithelium off. Once it is observed that the Riboflavin has penetrated the stroma and is seen in the anterior chamber, the cornea is exposed to Ultraviolet light at an irradiance level of 18mW/cm2 for 5 minutes. A contact lens is applied until the epithelium has fully healed in 3 to 5 days. The study is for 6 months. The corneal curvature as well as the uncorrected and best corrected vision and corneal thickness are evaluated pre-operatively and at 6 months. The primary variable that is assessed to determine the efficacy of the drug is the Kmax - Steep corneal curvature. Secondary effectiveness criteria are uncorrected and best corrected vision and corneal thickness. adverse events are also monitored.

Eligibility Criteria:
INCLUSION CRITERIA GENERAL:

1. 12 years of age or older
2. Signed written informed consent
3. Willingness and ability to comply with schedule for follow-up visits
4. Contact lens removal prior to evaluation and treatment
5. Candidates must also have two of the following criteria:

   1. Presence of central or inferior steepening on the Pentacam or Orbscan map consistent with Keratoconus.
   2. Axial topography consistent with keratoconus.
   3. Steepest keratometry (Kmax) value of 47.00D

INCLUSION CRITERIA FOR ECTASIA:

History of having undergone a keratorefractive procedure and 2 of the following criteria:

1. Steepening by topography, either Pentacam or Orbscan
2. Thinning of cornea
3. Shift in the position of thinnest portion of cornea
4. Change in refraction with increasing myopia
5. Development of myopic astigmatism
6. Development of irregular astigmatism
7. Loss of BSCVA

   EXCLUSION CRITERIA:

   I. Eyes classified as either normal or atypical normal 2. Corneal pachymetry 350 microns at the thinnest point measured by Pentacam in the eye to be treated 3. A history of chemical injury or delayed epithelial healing in the eye to be treated.

   4. Pregnancy (including plan to become pregnant) or lactation during the course of the study 5. A known sensitivity to study medications 6. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment 7. Inability to cooperate with diagnostic tests. 8. Patients with a concomitant condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.

   9. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.

   10. Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.

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Efficacy and Tolerability of BAF312 in Patients With Polymyositis

This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic drugs).

This study was stopped prematurely due to overall slow recruitment and no evidence for efficacy in a parallel study in dermatomyositis with an assumed similar pathophysiology. With very small sample sizes per group the overall results for this study including primary and all other efficacy and PD data are inconclusive

Eligibility Criteria:
Inclusion Criteria:

* "definite" or "probable" for polymyositis at least three months before Baseline
* active disease as defined by elevated CK levels, or other enzymes, or MRI/biopsy if enzymes are normal, and persisting muscle weakness
* stable dose of corticosteroid for at least 2 weeks prior to Baseline and should not have received a medium or high dose in the last 8 weeks prior to study entry.
* patients treated with methotrexate must have been on a stable dose for at least 6 weeks prior to Baseline.

Exclusion Criteria:

* Patients with overlap polymyositis, late-stage polymyositis, or other types of myositis.
* Preexisting severe cardiac or pulmonary involvement, malignancy of any organ system or significant eye diseases.
* Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.
* Pregnant or nursing (lactating) women
Effects of Acapella With Conventional Chest Physiotherapy Techniques in Post CABG Patients.

To determine the effects of using Acapella as an oscillatory positive expiratory pressure device in combination with conventional chest physiotherapy for secretion removal and revival of pulmonary functions in hospitalized post coronary artery bypass grafting patients.

Acapella is one of the Oscillatory Positive Expiratory Pressure (OPEP) device used in mobilization of peripheral secretions to the central trachea. It consists of a mouth piece and metal strip that is attached to a magnet which oscillates upon exhalation of the patient into the device results in oscillations. This helps in generating positive expiratory pressure (PEP) and oscillations of the magnetic ball assist in mucus collection and expectoration. Pulmonary functions are greatly reduced in patients undergone CABG surgery due to prolong effects of anesthesia and muscle relaxants administered prior to surgery. Ciliary motion along the pathway of pulmonary tract is depressed which results in decrease expectoration capacity, causes mucus retention and reduces pulmonary volumes and capacities. Chest physiotherapy is the treatment option for such patients that is being practiced over years. In recent years certain respiratory aids or devices are also in use to relieve secretion retention along with standard chest physiotherapy techniques.

The purpose of this study is to find the effects of using Acapella as an OPEP device along with conventional chest physiotherapy techniques in post-CABG surgery patients to relieve mucus retention and improving pulmonary functions post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders within age range of 45-65 years
* Elective CABG surgery patients
* Patients undergoing Phase 1 cardiac rehabilitation post CABG
* Patients who are vitally stable post operatively

Exclusion Criteria:

* Patient having prolong intubation period post-operatively
* Patients having long term arrythmias prior to surgery
* Patients having an implanted pacemaker
* Patients having uncontrolled diabetes, sepsis or any metabolic condition
* Patients with impaired cognition.
Puzzle Game Strategy on Older Adults

One innovative approach uses puzzle game strategies, including crosswords, Sudoku, and other brain-teasing activities. These strategies have been shown to help maintain attention, improve memory, and keep older adults' thoughts clear and sharp. Additionally, engaging in these activities can provide psychological benefits by offering a sense of achievement, reducing stress, and fostering social interactions.

Cognitive abilities naturally decline as people age, one factor leading to deteriorating psychological health among older adults. Therefore, it is crucial to develop interventions to enhance this population's cognitive abilities and psychological well-being through non-pharmacological complementary treatments. Such interventions should focus on improving these symptoms while replacing traditional therapies.

One innovative approach uses puzzle game strategies, including crosswords, Sudoku, and other brain-teasing activities. These strategies have been shown to help maintain attention, improve memory, and keep older adults' thoughts clear and sharp. Additionally, engaging in these activities can provide psychological benefits by offering a sense of achievement, reducing stress, and fostering social interactions.

Given puzzle games' potential to enhance cognitive and psychological health, exploring their effectiveness as a non-pharmacological intervention for community-dwelling older adults is essential. This research aims to fill the gap by empirically investigating the impact of puzzle game strategies on cognitive functioning and psychological well-being in this demographic.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years and above.
* Able to communicate effectively.
* Have mild or moderate cognitive impairment,

Exclusion Criteria:

* Have rheumatoid arthritis.
* Hand tremors that could limit their ability to use puzzles.
Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 3)

This is a single center phase 1 trial to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab to treat hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens.

This study is one of the cohorts of a multi-cohort trial called Combination of Metronomic capecitabine with Camrelizumab for treatment of refractory solid tumor (McCrest) trial.

Hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens will be treated by metronomic capecitabine plus camrelizumab. Metronomic capecitabine will be given as fixed dose (500mg bid) orally. Camrelizumab will be given two-weekly (200mg once) intravenously. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Eligibility Criteria:
Inclusion Criteria:

1. Male/female patients aged≥18 years.
2. Histologically confirmed hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi), without uncontrolled pleural effusion or ascites.
3. Patients with advanced or metastatic disease who have disease progression after all standard regimens, with measurable or unmeasurable lesions.
4. MSS or pMMR.
5. ECOG performance status 0 or 2, expected lifetime≥3 months.
6. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
7. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml).
8. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
9. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

1. Pregnancy or children bearing potential.
2. Brain or meningeal metastasis.
3. With second primary malignant diseases.
4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone).
5. With uncontrollable complications
6. Inadequate organ function
7. Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
8. known hypersensitivity reaction to any of the study drugs or components.
9. Other unsuitable conditions determined by investigators.
Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP)
3. Subject has altered gastric anatomy
4. Subject must be able to give informed consent.

Exclusion Criteria:

1. Any contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with overtube
2. The subject is unable to give informed consent
The Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems

In the literature, there are studies conducted to determine the effect of simulation-based and different training techniques models given in the prenatal period on postpartum breastfeeding self-efficacy. However, no study was found that evaluated the effects of simulation-based and different training techniques given in the prenatal period on breastfeeding self-efficacy and breastfeeding problems. Therefore, this study was planned to determine the effect of simulation-based breastfeeding education on breastfeeding self-efficacy and breastfeeding problems in the prenatal period.


Eligibility Criteria:
Inclusion Criteria:

* Pregnants between32nd-36th gestational weeks,
* Primigravida,
* Planning to breastfeed,
* Can speak and understand Turkish,
* Pregnant women who agreed to participate in the study were included.

Exclusion Criteria:

* Breastfeeding contraindications,

  * Having a risky pregnancy, Having received a planned breastfeeding training before,
  * Premature birth (before 37th weeks of gestation),
* Having a systemic/chronic disease
Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy

From January 2017 to January 2022, we looked at patients who had primary LSG and developed GERD. Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study. Patients with morbid obesity, defined as a BMI of more than 40 or less than 35 with at least one comorbidity and ages ranging from 16 to 65, were patients' eligibility criteria for LSG. Patients under the age of 16 or over 65, as well as those with severe GERD, pregnancy, or inflammatory bowel disease, were excluded from the trial.

The data were recorded in a prospective manner in a computerized file, all patients signed the informed consent form after the description of the technique and possible postoperative morbidities.

Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

The study's purpose was to determine the prevalence of GERD symptoms, as well as potential predictors of GERD symptoms following LSG and how GERD symptoms were managed after LSG.

Eligibility Criteria:
Inclusion Criteria:

* Patients with morbid obesity defined as a BMI of more than 40 or
* BMI less than 35 with at least one comorbidity and
* ages ranging from 16 to 65, were patients'

Exclusion Criteria:

* Patients under the age of 16 or over 65,
* those with severe GERD,
* pregnancy, or
* inflammatory bowel disease,
Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19 Compared to the Placebo

To evaluate the efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 19 as of the signed date in written consent
* Subjects with mild or moderate COVID-19 according to RT-PCR test (Total score of NEWS is 0-6 or if one item is 3 points)
* Subjects who have symptoms within 7 days or 72 hours after diagnosis

Exclusion Criteria:

* Subjects who cannot orally administer the investigational products
* Subjects who need administration of immunosuppressants
* Subjects who are allergic or sensitive to investigational products or its ingredients
* Subjects who have a history of drug and/or alcohol abuse within 52 weeks before screening
* Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
A Study of KL340399 in Patients With Advanced Solid Tumors

This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 injection in patients with advanced solid tumors.

This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 injection in patients with advanced solid tumors.The dose increasing method of "BLRM" is used to explore the safety, tolerance and determine the maximum tolerated dose(MTD).

Eligibility Criteria:
Inclusion Criteria:

1. Patient is at least ≥18 years of age (male or female);
2. Patients with histologically and/or cytologically confirmed advanced solid tumors who have failed standard of care, or who have no available standard of care regimen, or who are unqualified for standard of care. Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1, estimated survival ≥ 3 months;
4. Adequate organ and bone marrow function (no blood components and cytokines are allowed within 14 days prior to the first dose) ;
5. More than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment, target therapy, and toxicity from previous antitumor therapy returned to baseline or CTCAE≤ grade 1;
6. Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 3 months after the end of dosing;
7. Patients voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

Exclusion Criteria:

1. Known history of severe allergies, or allergy to any component of KL340399;
2. Received any previous therapy of STING-activating, or received any immunostimulant therapy within 28 days；
3. Have other malignancies within 5 years;
4. Concomitant or known metastases to brain or central nervous system;
5. Active autoimmune disease;
6. History of major cardiovascular diseases;
7. Uncontrolled systemic diseases；
8. Known of coagulation disorders, hemorrhagic disease;
9. Confirmed serious lung disease or lung disease;
10. Subjects with third space fluid that can not be controled by drainage or other methods;
11. Known active infection;
12. Known HIV, active hepatitis B/C virus;
13. Pregnant or lactating women;
14. Received immunotherapy and had immune related adverse reactions ≥ grade 3;
15. Have received stem cell transplantation or organ transplantation;
16. Receive any live or attenuated live vaccine within 4 weeks;
17. History of serious dementia, altered mental status, or any psychiatric disorder;
18. Evidence of alcohol or drug abuse;
19. Participated in any other clinical trials and received treatment within 4 weeks;
20. Have other factors based on which the investigator considers that the subjects are not appropriate to participate in the study.