cyrilzakka/clinical-trials huggingface dataset:
Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse

This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (\> 6 months).

The main purpose of this research study is to find out if treatment of late relapse of ovarian or fallopian tube or primary peritoneal cancer with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin. And it is hoped that substituting paclitaxel with Caelyx in combination with carboplatin will improve the tolerance of the treatment program with at least the same efficacy and fewer side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18
* Histologically proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors
* Measurable disease (Response Evaluation Criteria in Solid Tumor \[RECIST\] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup \[GCIG\] criteria) or with histologically proven diagnosis of relapse
* Disease in progression \> 6 months after a first or second platinum-based line. Patients should have previously received a taxane derivative.
* ECOG performance status \< 2
* Life expectancy of at least 12 weeks
* Adequate bone marrow, renal, and hepatic function

Exclusion Criteria:

* Ovarian tumors of low malignant potential
* Non-epithelial ovarian or mixed epithelial/non-epithelial tumors
* Previous radiotherapy
* Prior diagnosis of malignancy
* Bowel obstruction, sub-occlusive disease, or presence of symptomatic brain metastases
* Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade \> 1
* History of congestive heart failure (New York Heart Association \[NYHA\] classification \> 2), history of myocardial infarction within the last 6 months, or history of atrial or ventricular arrhythmias
* Severe active infection
* Severe hypersensitivity to products containing Cremophor EL and/or to compounds chemically related to paclitaxel, carboplatin or Caelyx
* Fertile women not using adequate contraceptive methods
* Pregnant or breast feeding women
Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer

Recurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme Q10 gel to treat the lesion and more safe for the participants.

Double randomized clinical trial study using two parallel group suffer from oral aphthous ulcer one take antioxidant topical q10gel and other group take placebo carpabol gel two times per day for seven days measuring outcome at fourth and seventh day including pain; healing period and clinical parameters.

Sample size of study include 26 in each group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with free medical history and no systemic diseases16.
* Patients clinically diagnosed as suffering from symptomatic oral minor aphthous ulcers.
* Patients who agreed to take medications.

Exclusion Criteria:

* Patients suffering from any systemic disease as Crohn's disease, Behcet's disease and others.
* Anemic and leukemic patients (using complete blood count investigation)
* Patients taking systemic drugs such as systemic steroids and other immunosuppressive therapy.
* Patients treated with any oral topical medications 48h before the study27.
* Pregnant and lactating mothers.
Sleep Disordered Breathing and Diabetes

The hypothesis of this study is: sleep disordered breathing (SDB), specifically, obstructive sleep apnea, is associated with poorer glucose in the existing type 2 diabetic condition.

In an exploration of this hypothesis, the investigators hope to provide evidence linking SDB to increased severity of disease in the type 2 diabetic patient. By doing so, the investigators ultimately seek to support investigating the use of SDB interventions as an additional method of care in the treatment of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* adult female and male patients with type 2 diabetes who are followed by University of Chicago physicians

Exclusion Criteria:

* patients with the diagnosis of type 1 diabetes (DM); newly diagnosed Type 2 DM patients
* patients with the diagnosis of OSA using CPAP for either 4 or more hours per night or 5 nights per week
The Association Between Pulmonary Function Tests and Difficult Airway

The airflow moving from mouth to the lungs, which can be measured by pulmonary function tests, may be affected by the anatomic disorders of the upper airway. Difficult airway can be considered as the anatomic disorder of the upper airway as well. Therefore, there can be a relationship between difficult airway and pulmonary function tests. The purpose of this study is to elucidate the association between the pulmonary function tests and difficult airway.

After approval of the Gaziosmanpasa University Clinical Trials Ethics Committee, patients those admitted to the anesthesiology outpatient unit will informed about the study. And pulmonary function tests by using Spirodoc® will be performed to those willing to participate in the study. Measurements of the pulmonary function tests, and measurements belong to difficult airway will be recorded.

In the operating theatre, after induction of anesthesia, the difficult intubation measurements will be recorded.

Normality and variance will be tested using One Sample Kolmogorov-Smirnov test, skewness, kurtosis and histograms for each variable. Quantitative data will present as means and standard deviation, and qualitative data as frequency and percentage. Depending on these results, Spearman's correlation analysis will perform to show the association between pulmonary function tests and difficult airway measurements. Analyses were conducted using the Statistical Package for Social Sciences program (SPSS Inc., Chicago, IL), version 20.0. Statistical significance for all analyses was set at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose admitted to the Gaziosmanpasa University, Medical Faculty, Anesthesiology and Reanimation outpatient unit
* Patients whose will be planned to undertake a surgical operation under general anesthesia and those performed tracheal intubation to secure the airway.
* An American Society of Anesthesiologists score of 1 or 2

Exclusion Criteria:

* Patient whose planned to undertake a surgical operation in the departments of ear-nose-throat, cardiac and vascular surgery, plastic and reconstructive surgery
* Patients with a history of chronic obstructive lung diseases
* Patients with a history of surgery on the neck
* Patients with a history of mandibular surgery
The Effectiveness of Lavender Aromatherapy Combined With Slow Breathing Exercises in Improving Occupational Burnout and Sleep Disorders Among Nursing Staff

This study investigates the effects of breathing exercises combined with lavender essential oil inhalation on occupational burnout and sleep disturbances in rotating shift nurses.

This study will adopt a randomized controlled trial (RCT) design targeting rotating shift nurses with at least six months of clinical experience at a regional teaching hospital in northern Taiwan. Eligible participants who consent to join the study will be randomly assigned into five groups using block randomization. The randomization process will be conducted via sealed envelopes to allocate participants into the following groups: Experimental Group 1, Experimental Group 2, Experimental Group 3, Breathing-Only Group, and Control Group.

Experimental Group 1: Participants will receive slow breathing training (6 breaths per minute) once daily before bedtime, combined with the inhalation of 3 drops of natural lavender essential oil on a towel, for 3 minutes, over a 4-week period.

Experimental Group 2: Same breathing protocol as above, with 3 drops of linalyl acetate-containing essential oil.

Experimental Group 3: Same breathing protocol, with 3 drops of linalool-containing essential oil.

Breathing-Only Group: Participants will perform slow breathing training (6 breaths per minute) for 3 minutes daily before bedtime, without any essential oil inhalation, for 4 weeks.

Control Group: Participants will maintain their usual lifestyle without any intervention.

The outcomes will be evaluated using a nurse burnout scale and a sleep quality scale. Measurements will be taken at three time points: baseline (pre-test), 4 weeks after the intervention (post-test 1), and 8 weeks after the intervention (follow-up/post-test 2).

The study is co-led by Yao-Hsiang Chen, Assistant Head Nurse at Tri-Service General Hospital Songshan Branch, and Professor Chia-Hui Lin, School of Nursing, National Defense Medical Center.

Eligibility Criteria:
Inclusion Criteria:

Aged between 20 and 65 years Registered nurses with at least 6 months of clinical experience and currently working rotating shifts Scores ≥1 in each of the three dimensions (emotional exhaustion, reduced personal accomplishment, depersonalization) on the Nursing Burnout Scale (NBS) Willing to participate in the study and accept random assignment

Exclusion Criteria:

Nurses with less than 6 months of clinical experience Individuals with anosmia or reduced sense of smell Diagnosed with psychiatric disorders Allergic to lavender essential oil Not currently working rotating shifts
A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients with Leukocyte Adhesion Deficiency Type II

The primary objective of this study is to evaluate the efficacy and safety of AVTX-803 compared to withdrawal in patients with Leukocyte Adhesion Deficiency, Type II (LAD II).


Eligibility Criteria:
Inclusion Criteria:

* Subject must be between 6 months and 75 years old
* Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)
* Subject has a documented history of Lewis antigen deficiency
* Subject has a history of recurrent infections, opportunistic infections or infections that did not respond well to standard of care treatment
* Subject or parent (for subjects under legal age for consent) has provided written informed consent for this study. Additionally, written informed assent has been provided, as appropriate, for minors of older age, per local institutional review board (IRB)/ethics committee (EC) policy and requirements
* Subject is willing and able to comply with the protocol
* Women of childbearing potential (WOCBP) meeting the criteria below:

  1. Non-lactating and has a negative pregnancy test at screening -AND-
  2. Uses an acceptable double-barrier method of contraception as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug.
* Male subjects must agree to use an acceptable double-barrier method of contraception with their partner as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug.

Exclusion Criteria:

* Subject has severe anemia defined as hemoglobin \<8.0 g/dL (\<4.9 mmol/L)
* Subject has impaired renal function as defined by an eGFR \<90 mL/min
* Subject has a total absence of fucosylation on red blood cells and the presence of anti-H antigen
* Subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product
* In the investigator's opinion, subject has a history of failure to respond to fucose at adequate dosing
* In the investigator's opinion, subject is not able or not willing to comply with the study requirements.
* Subject is pregnant
Video Screening for Visual Impairment of Infants

An individual senses the world and reflects feedbacks via independent behaviors. Such precise collaboration of the sensory and behavioral systems is fundamental to survival and evolution. When a sensory modality is altered, the behavioral system has the potential to fit in a substitute modality. However, the specific dynamics of human behaviors in response to sensory loss remain largely unknown due to the paucities of representative situations and large-scale samples.

Here, the investigators focused on thousands of human infants who suffered varying degrees of visual stimuli deficiency in early stages, while their behavioral systems remained sensitive and thus retained high behavioral plasticity. Having access to this unique population provides an unprecedented opportunity to investigate the effect of diverse visual conditions on the behavioral system and develop a domestic apparatus for screening visual impariment of infants.


Eligibility Criteria:
Inclusion Criteria:

* Younger than 4 years of age

Exclusion Criteria:

* Any brain and mental illnesses, or other known illnesses that may affect the behavioral patterns
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes
* Subject has a diabetic foot ulcer 5cm squared or greater
* Subject's diabetic foot ulcer is chronic

Exclusion Criteria:

* HgbA1c of 12% or greater
* Presence of cellulitis
* Presence of osteomyelitis
Association of Probiotics With Neurostimulation of Dermatome T6: Effect on Weight Loss in Obese Patients

Patients will be randomized into 2 groups:

* Group 1:Patients undergoing PENS T6, who also received Probiotics, during 10 weeks.
* Group 2: Patients undergoing PENS T6 during 10 weeks. They will not received Probiotics

Weight loss after 10 weeks of treatmente will be assessed.

Patients will be randomized into 2 groups:

* Group 1:Patients undergoing percutaneous electrical stimulation of dermatome T6 (PENS T6), who also received Probiotics (Adomelle 1 caps/12h), during 10 weeks.
* Group 2: Patients undergoing PENS T6 during 10 weeks. They will not received Probiotics

Weight loss after 10 weeks of treatmente will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 Kg/m2

Exclusion Criteria:

* Patients with pacemakers or implanted electrical devices.
* Pregnant women
* History of allergy to Probiotics
Observational Study of Type 1 Diabetics Switching From Human Insulins to Modern Insulin Analogues

This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania.


Eligibility Criteria:
Inclusion Criteria:

* Any subject with type 1 diabetes who is treated with human rapid and intermediate (NPH) insulin in basal-bolus regimen

Exclusion Criteria:

* Subjects currently being treated with insulin aspart and insulin detemir
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to insulin aspart or to any of the excipients
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients
* Women who are pregnant or have the intention of becoming pregnant within next 6 months
IMN Diameter to Femoral Canal Diameter and Union

To Detect the Relation Between the Intramedullary Nail Diameter to Canal Ratio and the Incidence of Non-union

Femoral intramedullary nail fixation is currently considered the ''gold standard'' for treatment of femoral shaft fractures in adult population. Clinical outcomes after operative treatment of proximal femur fracture have been shown to be dependent on achieving optimal mechanical alignment and union. Patient independent risk factors associated with nonunion after intramedullary fixation includes: open fracture, undreamed intramedullary nailing, fracture comminution, non-isthmal and particularly infra-isthma fracture location and infection. Patient dependent risk factors include smoking, diabetes, nonsteroidal anti-inflammatory medications, closed head injury and delayed weight. Unreamed nailing allows for better maintenance of the endosteal circulation at the expense of smaller diameter implants; in contrast, reamed applications permit a larger diameter nail, resulting in stronger fixation constructs and earlier fracture union. After reaming, a larger diameter intramedullary nail is placed. When initially reported, this treatment resulted in high success rates.

Eligibility Criteria:
Inclusion Criteria:

1. Age (20_60) years old
2. Closed fracture and open grade one
3. Midshaft fractures type3\\2 according to the OA classification
4. pattern of the fracture (simple transverse,oblique ,spiral)
5. Retrograde and Antigrade nail

Exclusion Criteria:

1. Open fractures grade two and three.
2. patient with comorbidities eg(DM.HTN...)
3. severe osteoporosis with wide medulla .
4. patient on regular steroid therapy.
5. patient refused to be enrolled in the study
Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

The purpose of this study is to determine if corticosteroid injection modifies the natural course of de Quervain tendinopathy compared to a toradol injection.

If steroids are effective for Dequervain tenosynovitis because of their anti-inflammatory properties, then there is a reasonable and rational argument to be made for the local injection of NSAIDS (non-steroidal anti-inflammatory drugs) into the first dorsal extensor compartment. Ketorolac is an NSAID that has been proven efficacious in the treatment of another musculoskeletal condition. Moreover, compared to betamethasone (or other injectable corticosteroids), injection of ketorolac decreases the patient exposure to the potential side-effects of corticosteroids, especially that of elevation of blood sugar levels in diabetics.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DeQuervain tendinopathy
* Understands the local language and is willing and able to follow the requirements of the protocol
* Understands the informed consent and signs the institutional review board/independent ethics committee (IRB/IEC) approved informed consent form

Exclusion Criteria:

* Patients who have an allergy to lidocaine, celestone, or ketorolac, nonsteroidal anti-inflammatory drugs (NSAIDs), or acetylsalicylic acid (ASA)
* Patients who have an adverse reaction to lidocaine, celestone, or ketorolac (such as severe elevation of blood sugars in diabetics that caused medical complication)
* Patients who have received a prior steroid injection within the past three months
* Patients who have had a prior ipsilateral surgery for DeQuervain Tenosynovitis
* Patients that have a skin lesion at the location of injection (such as trauma, eczema, rash)
* Patients who have a current infection at the location of injection
* Patients who have had iontophoresis within three months
* Patients who are breast feeding, pregnant, or who plan to become pregnant in the next six months
Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia

Outcomes for children with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) are dismal. Therefore, the investigators performed this multicenter, phase II study to evaluate the efficacy and , safety and pharmacokinetic of clofarabine in Chinese pediatric patients with R/R ALL


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (younger than 21 years old) with acute lymphoblastic leukemia confirmed by histology
* Refractory or relapsed acute lymphocytic leukemia who had received at least two drugs treatment
* No prior chemotherapy within 2 weeks before entry and resolution of toxic effects from prior therapy
* Normal cardiac function, adequate hepatic function \[total bilirubin ≤1.5× upper limit of normal (ULN), aspartate aminotransferase (AST) alanine aminotransferase (ALT) ≤ 3ULN\] and renal function (serum creatinine ≤ 2 ULN)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy more than 3 months

Exclusion Criteria:

* AEs not recovered from prior therapy
* Within 3 months from allogeneic or autologous stem cell transplantation
* With central nervous involvement or uncontrolled infection
* Patients who used clofarabine before or allergic to fludarabine or cladribine
PD-L1 Expression on CTCs in HNSCC Patients Underwent Curative CCRT

Head and neck squamous cell carcinoma (HNSCC) is the 4th highest incidence of cancer and 6th of cancer death of the males in Taiwan. Because the patients were mainly middle-aged male, the disease eventually resulted in a huge loss of labor force, productivity and a huge burden of family supports and medicinal costs. Unfortunately, the incidence and death of HNSCC seemed to be increasing in Taiwan. Currently, the primary treatments of HNSCC are mainly surgery, radiotherapy, chemotherapy or targeted therapy or concurrent chemoradiotherapy. Immune checkpoint inhibitors become an emerging treatment in recent days. However, how to select adequate patient by using biomarkers remains an unsolved problem. Therefore, investigator have developed a new method for isolation and detection of circulating tumor cells (CTCs) in HNSCC patients. Moreover, the expression of immune markers (such as PD-L1, PD-L2, PD-1) on CTCs or immune cells might be a good target to study. Investigator's preliminary data found CTCs and circulating cancer stem-like cells but not PD-1 expression levels on peripheral T cells in patients with recurrence or metastasis HNSCC did not associated with overall survival. Therefore, investigators are wondering if PD-L1 more specific due to it expression on cancer cells. Therefore, in the 3-year project, investigators will utilize developing device and protocol in first year and then enroll 40 freshly diagnosed participants with head and neck cancer at stage III-IV with intent to receive curative concurrent chemo-radiotherapy (CCRT), and then analyze CTCs, PD-L1 expression levels on CTCs. Blood sample will be taken before, during (definition: 3-6 weeks after start RT) and after (definition: 4 +/-2 weeks after complete CCRT) completion of CCRT. Investigators will also enroll 10 health participants and taking blood sample for 3 times and follow up. Further statistical tests with clinical conditions (disease status, treatment effects, progression or distant metastasis and death) will be performed to elucidate their clinical significance. Hopefully, investigators will clarify the correlation between clinical outcomes and expression of PD-L1 on CTCs in head and neck patients. This could be a new biomarker for clinical cancer care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck squamous cell carcinoma with age at diagnosis ≥ 20 years
* Stage III-IV according to AJCC 8th ed.
* Intent to receive curative concurrent chemoradiotherapy (CCRT)
* 10 healthy donors without any cancer diagnosis within 5 years

Exclusion Criteria:

* P16 positive oropharyngeal cancer
* Non-Platinum based CCRT
* Previous diagnosed with cancer within 3 years
* Synchronous cancer
* Poor compliance, cannot cooperate for blood sampling for CTCs isolation as time schedule or clinical treatment or follow-up