cyrilzakka/clinical-trials huggingface dataset:
Comparing the Safety and Cosmetic Outcomes Between Laparoscopic Versus Traditional Open Breast-conserving Surgery

In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.

In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required to ensure the efficiency of cure. Also, less scars and breast preservation has becoming more and more important for patients' acceptance to the treatment. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female over the age of 18
* Preoperative pathologically confirmed invasive breast cancer or ductal carcinoma in situ
* Clinical classification T1, T2 (maximum tumor diameter ≤5cm)
* Single-center tumor (preoperative confirmation by B-ultrasound, MRI and other imaging examinations)
* No clinical or imaging evidence of distant metastasis
* Able and willing to sign informed consent

Exclusion Criteria:

* Tumor in the lower inner quadrant
* Tumor in multiple quadrants
* Imaging or intraoperative pathology indicates tumor invasion of the nipple areola, skin, or pectoralis major
* Locally advanced breast cancer patients are undergoing neoadjuvant therapy
* Tumor in multiple quadrants
* Have been participating in other clinical trials, which may affect the participation in this trial
* Previous history of breast cancer (patients with recurrence after ipilateral breast-conserving surgery)
* Pregnant and lactating women
* Patients with severe cardiopulmonary disease or severely impaired lung function are not suitable for surgical establishment of an air cavity
Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality

Spatial navigation refers to the ability to maintain a sense of direction/location while moving around the environment so to find one's way. It includes abilities such as orienting in complex environments,perceiving distance and planning routes to distant locations as well as mentally representing the reciprocal relations of landmarks in space (Lawton, 2010; Wolbers \& Hegarty 2010. Spatial navigation involves the precision in encoding multisensorial (visual, vestibular, proprioceptive)experiences, as well as to form mental representations to be used to guide behavior (Bianchini et al.,2014).

Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by movement and posture disorders causing activity limitation. Impairment in many other functions is common in CP including visual spatial competences and spatial organization. In this study the investigators meant to explore the navigation and learning strategies in children with CP.


Eligibility Criteria:
Inclusion Criteria:.

* diagnosis of bilateral CP;
* age between 8 and 14 years old;
* severity of motor impairment classified in levels I, II and III, according to the Gross Motor Function Classification System (GMFCS) (Palisano et al., 1997)
* or according to the Manual Ability Classification System (MACS) (Eliasson et al., 2006);
* ability to follow instructions.

Exclusion Criteria:

* severe muscle spasticity and/or contracture,
* a diagnosis of severe learning disability,
* behavioral problems,
* visual or hearing difficulties that would affect the feasibility of proposed activities and/or compliance
Clinical Study to Evaluate the Efficacy of Ectoin® Containing Eye Spray for Treatment of Dry Eye Disease

Subjective and objective evaluation of the efficacy and tolerability of preservative-free "Ectoin® Eye Spray - Colloidal" and comparison of the efficacy and tolerability between "Ectoin® Eye Spray - Colloidal" and Tears Again® in patients with mild-moderate dry eye disease

"Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neuro- sensory abnormalities play etiological roles." (DEWS II Report, 2017).

For the treatment and prevention of dry eye disease (DED) there are a number of treatment modalities available, depending on the severity and classification (aqueous deficient / evaporative) of the disease. The liposomal eye spray Tears Again® (TA, Optima Medical Swiss AG - medical device with CE marking) represents an option to treat mild to moderate evaporative DED. A novel preservative-free eye spray, Ectoin® Eye Spray - Colloidal (EES09; bitop AG -medical device with CE marking), was developed, in which colloids (colloidal lecithin emulsion) serve as a carrier for Ectoin. Ectoin is known as a natural cell-protective and inflammatory-inhibiting molecule. The principle mode of action of Ectoin is based on the physical interaction of this compatible solute with water and the resulting effects of the Ectoin-Hydro-Complex on the tissue treated.

The aim of this study is to subjectively and objectively evaluate the efficacy and tolerability of preservative-free "Ectoin® Eye Spray - Colloidal" and to compare the efficacy and tolerability between "Ectoin® Eye Spray - Colloidal" and Tears Again® in patients with mild-moderate dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age 18 years
* OSDI Score of at least 18
* NIBUT smaller or equal to 10s in at least one eye

Exclusion Criteria:

* Post-operative trauma or injury
* Ocular disease with exception of DED
* Hypersensitivity to any of the ingredients in the products used for this study
* Contact lens wear 24h before or on the day of study visits
* Use of eye drops / other eye sprays on the day of visit 1 or during the duration of the study period
Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration

Assess the effectiveness of externally applied micro current electrical stimulation on improving the ETDRS visual acuity in subjects with vision loss from dry age-related macular degeneration (AMD)

Micro-current electrical stimulation will be used to treat /each eye in a group of subjects with dry AMD. 60 subjects will be randomly divided into two groups. A ratio of 1:3 will be maintained between control and the experimental groups. In the treatment group, subjects will undergo a treatment session to the enrolled eyes daily for three days during week 1, followed by a single treatment session during weeks 2, 14 and 26 with the Nova Oculus device. A second group of subjects will act as the control group. This group will undergo sham treatment at the same treatment intervals with a non-functional Nova Oculus device. ETDRS visual acuity will be performed on all subjects at enrollment prior to each treatment and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the ETDRS visual acuity of subjects with dry AMD will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Fifty years of age or older
* Male or female
* Best-corrected vision 20/50 to 20/200 for each enrolled eye
* Confirmed diagnosis of dry AMD
* Vision loss attributable to dry AMD
* Subjects must be highly motivated, alert, oriented, mentally competent and able to understand and comply with the requirements of the study, abide by the restrictions, return for all required visits, and provide voluntary informed consent

Exclusion Criteria:

* Any visually significant retinal pathology other than dry AMD
* Previous intravitreal injection
* Seizure disorders
* Previous vitreo-retinal surgery. (ERM, PPV, RD etc)
* Dense cataract
* Eyelid pathology at the treatment sites
* Glaucoma patients with a visual field mean defect of greater than 10dB on Humphrey visual field testing
* Glasses are up to date (prescription \<1 year old)
* Any prior electrical micro-stimulation treatment to the eyes
* Poor general health
* Active cancer
* Life expectancy less than 12 months
* Non-ambulatory
* Not considered suitable for participation for any other reason
30-Second Sit-to-Stand Test for Assessing Functional Capacity in Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA) is a heterogeneous, idiopathic, chronic inflammatory, rheumatic disease that is most common in childhood and is thought to involve immunological mechanisms in its etiopathogenesis. The physiology of children and adolescents is constantly changing due to the development and maturation of their systems. At the same time, the changes that this population shows, especially during the growth spurt and adolescence, can affect their performance in frequently used functional tests such as the 6-Minute Walk Test (6MWT). At the same time, it is emphasized that alternative tests are needed because the evaluation procedures of the 6MWT are not practical enough. The aim of this study is to investigate whether 30 Second Sit to Stand Test (30SST) is an alternative tool for assessing functional capacity in patients with JIA.

H0: 30SST is not an alternative tool for assessing functional capacity in patients with JIA.

H1: 30SST is an alternative tool for assessing functional capacity in patients with JIA.

The study will include 60 adolescent patients with oligoarticular/polyarticular JIA between the ages of 12-18. The 6MWT, 30SST and 10 Stair Climb Test (10SCT) will be applied to the cases that meet the inclusion criteria to evaluate their functional capacity. Demographic data and test results of the participants will be recorded and evaluated with statistical analysis methods. We believe that alternative tests that can be used to evaluate functional capacity in patients with JIA will contribute to the literature as a result of this study.


Eligibility Criteria:
Inclusion Criteria:

* Being 12-18 years old
* Having been diagnosed with JIA at least 6 months ago at the Istanbul Medical Faculty Pediatric Rheumatology Clinic
* Having a diagnosis of Oligoarticular/Polyarticular JIA
* Volunteer to participate in the study

Exclusion Criteria:

* History of trauma or surgery affecting the musculoskeletal system within the last 6 months
* Having an additional chronic disease affecting the musculoskeletal system
* Having vision or hearing problems
* Having cognitive impairment at a level where the person cannot understand the commands given.
* Having vision or hearing problems
* Having had a corticosteroid injection into the knee or ankle within the last week
* Difference in length in the lower extremities
Circadian Rhythms and Sleep in Familial DSPS and ASPS

The purpose of this study is to determine the properties of circadian rhythms and sleep propensity in familial advanced and delayed sleep phase syndrome (DSPS).

BACKGROUND:

Tremendous progress in the past few years has led to the identification of several circadian clock genes. This now makes it possible to determine how alterations of human circadian clock genes and their expression could lead to differences in circadian and sleep/wake cycle phenotypes. Of particular interest for understanding genetics of the human circadian system are individuals with sleep phase disorders, such as DSPS and advanced sleep phase syndrome (ASPS), because recent studies indicate a genetic basis for these disorders. While it is assumed that both ASPS and DSPS are disorders of circadian timing, little is known about how the circadian clock system, or its interaction with sleep processes, are affected in these individuals.

DESIGN NARRATIVE:

Participants will complete questionnaires and actigraphy to determine sleep patterns and quality.

Eligibility Criteria:
Inclusion Criteria for ASPS Participants:

* Morning type score on the Horne-Ostberg questionnaire
* Advanced melatonin onset

Inclusion Criteria for DSPS Participants:

* Evening type score on the Horne-Ostberg questionnaire
* Delayed melatonin onset

Inclusion Criteria for Controls:

* A stable sleep/wake pattern with a normal phase relationship to the environment and no history of sleep disorders

Exclusion Criteria for all subjects:

* Sleep disorder, other than DSPS or ASPS, as assessed by the Pittsburgh Sleep Quality Index and/or by polysomnogram
* History of cognitive or other neurological disorders
* History of Diagnostic and Statistical Manual-IV criteria for any major psychiatric disorder, alcohol or substance abuse
* Abnormal mood as assessed by the Hamilton Depression Scale
* History of, or concurrent, unstable or serious medical illness
* Current use of psychoactive medications, including antidepressants, anxiolytics, neuroleptics, anticonvulsants, hypnotics, and stimulant medications
* Shift work
* Having a daily caffeine intake greater than 4 cups per day
* Smoking
* Travel across more than 2 time zones within 90 days of the study
* Pregnancy or the desire to become pregnant during the study period
Register Study of the Neoadjuvanten Treatment by Patients With Rectumcarcinoma

goal of this study is to check the effecivity, feasibility and toxicity of the chemoradiotherapy and hyperthermia

Radiation: 5x1,8Gy until 50,4 Gy Hyperthermia: 2x/week

Chemotherapy:

neoadjuvant= day 1-5 and day 29-33 5FU 1000mg/m2 adjuvant = 4 Cycles 5FU 500mg/m2 all 4 weeks

Eligibility Criteria:
Inclusion Criteria:

adenocarcinoma until 10 cm until ano UICC II+III 18-80 years old ECOG PS 0-2 Informed Consent

Exclusion Criteria:

cardiac insufficiency last 6 month heartattack nodal AV pressure III° hip prothesis cardiac pacemaker others contraindikations against the therapie radiation of pelvis chronic gestrointestinal desaese gestation or lactation previous radiotion pelvis previous Chemotherapie second carcinoma beside baslioma infiltation in analarea
Prediction Model of Response for CCRT in Esophageal Cancer

1. Retrospective review of old patients

   * Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015
2. Prospective case-control study: RNA sequencing \& miRNA microarray

   * naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy

     * acquirement of tissue, blood, clinical information
     * isolation of RNA, DNA, serum database of clinical \& demographic information

   \*\*\*Analysis of mRNA sequencing / miRNA sequencing\*\*\*\* first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator
3. Experimental set for qPCR (esophageal tissue) study group
4. TMA for screened exon gene
5. validation set for qPCR (esophageal tissue)
6. follow-up of circulating miRNA in blood (baseline blood \& post-CCRT blood 3M, 6M, 12M)
7. Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors
8. Validate the prediction model.

1. Retrospective review of old patients

   * Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015

   Study Group
   1. non responder
   2. CR but recurrence
   3. CR and survival loner than 2 years
2. Prospective case-control study: RNA sequencing \& miRNA microarray

   * naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy --\> acquirement of tissue, blood, clinical information --\> isolation of RNA, DNA, serum database of clinical \& demographic information

study group

1. non-responder (N=14)
2. Complete Remission (N=14)

   For considering the drop rate, 2-fold screening

   \*\*\*Analysis of mRNA sequencing / miRNA sequencing\*\*\*\* first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator

   3) Experimental set for qPCR (esophageal tissue) study group
   1. non-responder (N=40)
   2. complete remission (N=40)

   4) TMA for screened exon gene

   5) validation set for qPCR (esophageal tissue) new esophageal cancer set
   1. non-responder (N=30)
   2. complete remission (N=30)

   6) follow-up of circulating miRNA in blood (baseline blood \& post-CCRT blood 3M, 6M, 12M)

   7) Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors

   Test several combination models
   1. gene + gene combination,
   2. gene + clinical information combination,
   3. gene + gene + clinical information combination

   8) Validate the prediction model.

   9) primary organoid culture and prediction of chemoradiotherapy response

Eligibility Criteria:
Inclusion Criteria:

1. locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy
2. persons who assigned the written informed consents.

Exclusion Criteria:

1. persons who did't assign the informed consents
2. other organ cancer
3. heavy alcoholics
Comparing the Clinical Characteristics of Male LADA, T1DM and T2DM Patients

Diabetes is a common chronic disease in most parts of the world. Diabetes-related complications are harmful to the human body. Different types of diabetes have different levels of harm to the human body. There are also fewer studies on the relationship between specific types of diabetes and clinical diseases such as osteoporosis and Hypogonadism. Therefore, clarifying the differences in the clinical characteristics of adult men with late-onset autoimmune diabetes (LADA) ,Classical type 1 diabetes (T1DM) and type 2 diabetes (T2DM) will help to further understand the effects of diabetes on bone metabolism and sex hormones.

Diabetes is a common chronic disease in most parts of the world. Diabetes-related complications are harmful to the human body. There are also fewer studies on the relationship between specific types of diabetes and clinical diseases such as osteoporosis and Hypogonadism. This study aimed to compare the prevalence of hypogonadism and osteoporosis among male patients with latent autoimmune diabetes (LADA), type 1 diabetes (T1DM) and type 2 diabetes (T2DM) and investigate the protective factors for hypogonadism and osteoporosis in these patients. This cross-sectional study evaluated male patients with LADA, T1DM, and T2DM who visited the endocrinology department of Shanghai Tenth People's Hospital for diabetes management. Sex hormones, lipid profiles, sex hormone-binding globulin (SHBG), glycosylated hemoglobin A1c, beta-cell function, uric acid, and osteocalcin were determined in serum samples. Therefor，clarifying the differences in the clinical characteristics of adult men with LADA, T1DM and T2DM will help to further understand the effects of diabetes on bone metabolism and sex hormones.

Eligibility Criteria:
Inclusion Criteria:

1. 30 \~ 80 years old male;
2. Meet the American Diabetes Association (ADA) definition and standards for diabetes

Exclusion Criteria:

1. having diseases that affect bone and calcium metabolism, such as hyperthyroidism, hyperparathyroidism, hypogonadism, cushing syndrome, rheumatoid arthritis, cirrhosis, or malignant tumor;
2. the use in the past 6 months of drugs that interfere with bone and calcium metabolism, such as sex steroids, vitamin D metabolites, calcitonin, bisphosphonates, and thyroid hormone;
3. moderate or severe liver and renal dysfunction, including serum alanine aminotransferase of 120 IU/L, aspartate aminotransferase of 80 IU/L, and serum creatinine of 120 μmol/L.

4）a history of congenital/hypogonadotropic hypogonadism or hyperthyroidism, or those who received testosterone replacement therapy in the past 6 months were excluded.
Events Before Death

Previous studies of the patients treated in RRI clinics suggest that hemodialysis patients undergo a certain consistent predictable pattern at the initiation of dialysis and before death. This pattern can be described as a group of patterns of patients' biological markers over a few months after starting dialysis and several months prior to death. Additional patterns can be observed that occur with changes in seasons or time of day. The aim of this study is to compare these patterns in patients treated in FMC-Asia, FMC-Europe, FMC-South America, and RRI-US populations. Noting that patterns in patient parameters are similar across continents, climates, and geographic variations only further accentuates the importance in the models that can predict patients' survival and provide an opportunity for timely intervention.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis vintage 2+ months
Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment

Randomized, blinded vehicle-controlled multicenter clinical trial (MAT072017) to determine the effect of vaginal ovules containing 2 mg of the tea extract Matuzalem on the subjective symptoms (5-point scale pruritus (itching), dolor (pain), rubor (redness), fluor (discharge), and fetor (odor)), and objective symptoms (pH, Nugent score) of bacterial vaginosis. An ovule containing only the vehicle (polyethylene glycol 3000 S) was used as a control. The study was blinded from the perspective of the subject, investigator, laboratory personnel and data analyst.

The objective was to determine whether vaginal ovule with tea extract once-daily for 5-7 days improves symptoms of intermediate vaginal flora and prevents the development of bacterial vaginosis.

Composite primary endpoint designed as a drop in the Nugent score, vaginal pH, or improvement of subjective symptoms was compared between the active and vehicle (polyethylene-glycol) arm after 7 days of application and following 7 days after the application.

Secondary outcome measures were (1) Correction of the vaginal environment (as previously defined) 7 days after the completion of the prescribed 7-day regimen (day 14); (2) change in each parameter separately; (3) change in individual subjective symptoms, (4) exploratory analysis of the microbial environment at each subject visit.

The study was approved and supervised by the National authority and Ethics committee and prospectively registered in the Czech national medical device trial registry RZPRO and the European medical device trial registry EUDAMED.

Eligibility Criteria:
Inclusion Criteria:

* premenopausal participants
* disturbed vaginal environment
* not in need of antibiotic or antimycotic treatment
* participants were citizens of the Czech Republic
* age between 18 and 55 years
* either a vaginal pH \> 4.5 or/and vaginal discomfort
* able to follow the prescribed regimen
* informed consents prior to any intervention, including diagnostic procedures.

Exclusion Criteria:

* no vaginal bleeding of unknown aetiology
* hypersensitivity
* pregnancy
* lactation
* period during enrollment
* antibiotics in the previous 30 days
* treated with any products with similar indication
* acute urogenital infection
* diabetes mellitus
* advanced oncologic disease
* participant to other trial
* Nugent score above 6