cyrilzakka/clinical-trials huggingface dataset:
Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients

The purpose of this multi-center clinical trial is to verify more effective on local control of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar) compared with cisplatin perfusion, with acceptable side effects.

Malignant pleural effusion, which can malfunction of circulatory and respiratory systems, is a common complication in advanced NSCLC, finally decreases the quality of life and lifespan. Nowadays, it is still a challenge to effectively control malignant pleural effusion. In this multi-center randomized and controlled clinical trial, 134 NSCLC patients diagnosed as malignant pleural effusion in the first time will enroll. Based on systemic chemotherapy and pleural cavity perfusion, all eligible patients are randomly assigned into treatment group (recombinant human adenovirus type 5 and Endostatin injections) and control group (cisplatin) with ratio 1:1. Local control rate and side effects are record respectively. The anticipation is that treatment group obtains faster and longer control of pleural effusion.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 yrs;
2. Kamofsky score (KPS) ≥70, and a predicted lifespan \>3 months;
3. Enough function of vital organs, such as heart, liver and kidney;
4. Advanced NSCLC diagnosed by cytology or pathology
5. Unilateral or bilateral of malignant pleural effusion in the first time;
6. Patients who are considered as malignant pleural effusion by cytology or biomarkers (CEA, CA199, CA125) in pleural effusion;
7. Without systemic infection or high fever;
8. Without active EGFR mutation or unwilling to targeted molecular therapy;
9. NO Anti tumor Radiotherapy chemotherapy and molecular targeted therapy,or Received Anti tumor Radiotherapy chemotherapy and molecular and clinical remission more than three months and in the past month ,disease progress with pleural cavity effusion but haven't use systemic or local anti tumor treatment.
10. No pleural cavity injection of antineoplastic drugs.

Exclusion Criteria:

1. Non-malignant pleural effusion;
2. Pleural effusion cause by other malignant tumors;
3. Allergic to Recombinant human adenovirus type 5 injection or Endostar;
4. Pregnant or lactation women;
5. Previously using Medicine for treating NSCLC with pleural cavity effusion by Systemic or pleural cavity perfusion treatment one month prior to enrollment;
6. Previously using the diuretics, albumin and anti-angiogenesis drugs, or dexamethasone one month prior to enrollment.
Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting

The purpose of this study is to investigate the prevalence of tissue homologous recombination repair (HRR)-related gene mutations (positive/negative/Variant of uncertain significance (VUS)), clinical outcome such as prostate-specific antigen-progression free survival (PSA-PFS), overall survivals (OS) and treatment pattern in mCRPC patients.

\<Methods\> Study design: multi-center, prospective cohort study

Data Source(s):

In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20\~30 sites in Japan. Study Population: mCRPC patients who diagnosed between 2014 and 2018. Exposure(s): N.A Outcome(s): Prevalence of tissue HRR-related gene mutations, clinical outcomes such as Over survival and PSA-PFS, Treatment pattern

Sample Size Estimations:

The target population is 155 patients based on the prevalence of HRR-related genes (BRCA1, BRCA2 and ATM) which is reported in previous global study (PROfound study).

Statistical Analysis:

This study is not intended to verify specific hypotheses, and the results are evaluated descriptively. There is no plan of interim analyses before the final analysis.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 20, Japanese men at the time of informed consent.
* Patients who provided informed consent. If the patient has died, opt-out will be applicable.
* Patients who are diagnosed as mCRPC between January 1st in 2014 and December 31st in 2018.
* Patients who have a FFPE tumor sample (primary or metastatic) with Formalin Neutral Buffer Solution.
* Patients which the investigator judges to secure the enough amount of tumor samples for future laboratory test.

Exclusion Criteria:

* Patients who have failed HRR-related gene mutation testing with the myChoice HRD plus in screening period.
* Patients who have an only FFPE primary tumor sample (primary or metastatic) with unbuffered formalin including acidic formalin.
* Patients who have taken an investigational medical product for prostate cancer from Jan 1st , 2014 to Dec 31st 2020.
Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy

This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female adults aged 19 or older.
2. Sighting, facilitation measurement are judged by the investigator to be the ratio of Benign Masseteric Hypertrophy.
3. Subject who understand and willing to perform with the procedures and visiting schedules of clinical trial.
4. Subject who voluntarily agree to participate in this clinical trial.

Exclusion Criteria:

1. Subject who is clinically significant facial asymmetry in visual measurement by the investigator.
2. Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
3. Subject who is deemed unable to participate in a clinical trial under the judgement of a Investigator.
OCT Measures Predicting FFR

Background: the decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Fractional-flow-reserve (FFR) represents the gold standard to evaluate ICL but optical-coherence-tomography (OCT) is a novel, promising, high resolution coronary imaging technique.

Objectives:

1. Investigate the relation between OCT and FFR parameters in ICL and understand if OCT measures may predict FFR.
2. Understand if OCT parameters may predict clinical outcome of patients with ICL not underwent revascularization on the bases of negative FFR.

Study design: multicentre, international, individual patient's level data pooled analysis.

Principal investigators that enrolled stable or unstable patients with ICL who underwent both FFR and OCT assessment of the same lesion, will be contacted to participate the study. Agreeing investigators will be asked to complete a structured database by providing a series of key baseline clinical and angiographic data, OCT and FFR parameters.

Collected dataset will include: sex, age, hypertension, diabetes, hypercholesterolemia, current smoking, family history of CAD, clinical presentation, previous PCI, previous MI, previous CABG, non-invasive ischemia, angina, n° of diseased vessels, diseased vessel, percentage diameter stenosis at quantitative coronary angiography (QCA% stenosis), length of stenosis at quantitative coronary angiography, presence of thrombus or ulceration, MLA, area stenosis at OCT, FFR protocol (intracoronary adenosine, endovenous adenosine, contrast) results and long term clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with angiographically-intermediate coronary lesion
* Patients who underwent both FFR and OCT assessment of the same lesion
Gene Polymorphisms Influencing Steroid Synthesis and Action

The extend of steroid biosynthesis and action is mainly dependent on underlying genetic polymorphisms and gene mutations. These sequence variations in multiple genes involved in steroid biosynthesis and action cause different diseases (for example congenital adrenal hyperplasia or disorders of sex development). In addition, sequence variations in several other genes may influence the severity of a genetically caused disease of steroid biosynthesis or action. By this, the differences in an observed phenotype may be explained. Within the study all genes necessary for adrenal and gonadal steroid biosynthesis and several genes which are known to influence the action of steroid hormones will be analysed in patients with congenital disorders of adrenal and gonadal steroid biosynthesis, disorders of steroid action and disorders of sex development. The primary aim is to set up a correlation of the disease phenotype with the different genotypes detected.


Eligibility Criteria:
Inclusion Criteria:

* Disorders of Sex Development
* Congenital Adrenal Hyperplasia
* Congenital Adrenal Hypoplasia
* Adrenal Insufficiency
* Mineralocorticoid Deficiency
* Salt-loss
Observation of the Natural Course of Age-related Macular Degeneration

This research will study natural course of dry AMD in Chinese population, screen fundus imaging indicators for patients with Chinese dry AMD, describe the clinical features of Chinese patients with dry AMD, and obtain a biological sample library of dry AMD mainly in China.


Eligibility Criteria:
Inclusion Criteria:

* 50-85 yrs male or female AMD patients
* Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus examinations.

Exclusion Criteria:

* Any eye with disease that would interfere with the retinal examinations
* Research eye with CNV or high myopia
* Surgeries that may interfere with AMD evaluation
* Long-term uses of medications that are associated with retinal or neural toxicities.
* IOP more than 26 mmHg
* Received cataract surgery in 3 months.
* Other conditions: diseases that causes less than 5 years survival; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer.
* Other conditions not suitable for the current study
Gender Specific Differences in Postoperative Sore Throat for Ambu® AuraGain™ Laryngeal Mask

The purpose of this study is to evaluate gender specific risk factors and the influence of cuff pressure in the occurrence of postoperative sore throat and hoarseness following general anaesthesia using Ambu® AuraGain™ Laryngeal Mask.

The history and physical examinations of all patients scheduled for surgery are screened preoperatively for exclusion criteria. Patient recruitment is conducted by one of the study physicians. After eligibility is confirmed and written informed consent is obtained, enrolled participants are randomized depending on their gender (400 men, 400 women) in a single-blinded manner (patients) 24 hours before the intervention in a 1:1 ratio to low cuff pressure (45 cmH2O) or normal cuff pressure (60 cmH2O). Patient questioning via questionnaire is conducted in postoperative anaesthetic care unit, 24h, 48h and 72h until freedom of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery in ophthalmology under general anaesthesia with laryngeal mask
* Age \> 18
* informed written consent

Exclusion Criteria:

* Anticipated difficult airway with indication for awake tracheal intubation
* Indication for RSI or elevated risk for aspiration;
* Pregnant or breastfeeding;
* Age \< 18 years;
* Obesity
* Out-patient surgery (Geb. 505);
* Limited mouth opening;
* Pre-existing hoarseness and sore throat
* Participant in other studies
* Unable to provide informed written consent or under guardianship
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy volunteers under fasting condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 19 years of age or older
* BMI ≥ 18.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of childbearing or non-childbearing potential

Exclusion Criteria:

* Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults

The study is aimed to assess a new system for the automatic detection, quantification and treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The system is comprized of a treadmill and a virtual reality simulation which provides a motor-cognitive challenge to provoke NF. The challenges provided by the system are individualized and using machine learning algorithms will enable the identification and detection of NF under different conditions and allow for the most suitable treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy older adults with a history of falls or complaints of gait instability
2. Able to walk independently for at least 10 minutes

Exclusion Criteria:

1. Systemic chronic or acute pathologies:

   1. Ischemic heart disease
   2. Orthopedic or Rheumatic diseases
   3. Severe vision problems
   4. Neurological disease: PD, AD, CVA
2. Patients who underwent brain surgery in the last 6 months prior to the study
Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair

background Operation for small umbilical hernias is one of the most common surgical procedures, but the best surgical technique, including the choice of suture or mesh remains unknown.

It is well known that using non-absorbable sutures in closure of the abdomen, diminishes the risk of incisional hernias and wound healing problems.It has also been found that the use of resorbable suture in fixation of the mesh in Lichtesteins procedure leads to greater risk of recurrence of the hernia. Furthermore, it has been stated in smaller studies, that the use of the mesh in open operation for a small umbilical hernia has lower risk of recurrence (approx. 1-3%) than sutured repair (10-12 %). However, the scientific literature is deficient, with few patients.

The purpose of this study is to describe reoperation rate of recurrence after small umbilical hernias, depending on choice of sutures in both regular repair and in mesh repair.

Hypothesis: sutured repair with non-absorbable suture has lower recurrence rates than with other types of sutures, whereas mesh repair has even lower recurrence rates in small umbilical hernia repairs.

National prospective registry study with data from the Danish ventral hernia Database (DVHD) and the National Patient Register (LPR) in patients undergoing open to umbilical or epigastric hernia repair during the period 1 January 2007 to 31 December 2010.

Apart from operator-registered perioperative data from DVHD, operations can be characterized with different types of sutures, choice of mesh and other relevant information, with possible impact on long-term outcome after surgery, including recurrence.

There will be used frequency analyzes and Kaplan Meyer statistics, supplemented by multivariate Cox regression analysis, as well as non-parametric statistics.

Eligibility criteria: OPen mesh or sutured repair for small umbilical hernias from 1th of January 2007 to 31th of December 2010.

Outcome measures: Reoperation as a surrogate for recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Mesh or non-mesh umbilical hernia repair hernia defect size max. 2 cm.

Exclusion Criteria:

* bigger defect than 2 cm. laparoscopic repair
Effect of Nurse-led Supportive Care on Caregiver Burden and Well-being

Breast cancer is the most common type of cancer in women with a high mortality rate in the world. Women may experience many different physiological and psychological symptoms (such as pain, nausea-vomiting, fatigue, stress, anger, and isolation) during diagnosis and treatment process. Family members often become caregivers at the time of diagnosis, and treatment of breast cancer patients. Therefore, family caregivers experience burden and poor health-related quality of life.

This a pragmatic, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on caregiver burden and well-being among primary caregivers of women with breast cancer. This trial was conducted in the chemotherapy outpatient clinic of training and research hospital located in Turkey. All primary caregivers were family members.

Eligibility Criteria:
Inclusion Criteria:

* Being the primary caregiver of breast cancer patients
* Literate
* Able to understand and complete the questionnaires
* Willingness to participate in the study

Exclusion Criteria:

* Having communication problems
* Having psychological diseases
* Receiving any supportive care
Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD

This study is designed to evaluate the safety, tolerability and clinical activity of RXI-109 administered by intravitreal injection to reduce the progression of subretinal fibrosis in subjects with advanced neovascular age-related macular degeneration (NVAMD).

Evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple doses of RXI-109 when administered by intravitreal injection. Evaluate the clinical activity of single and multiple doses of RXI-109 when administered by intravitreal injection. Study participation is intended to be seven months from time of initial treatment with RXI-109.

Eligibility Criteria:
Inclusion Criteria:

* Subjects presenting with advanced NVAMD in the study eye with BCVA ≤20/100 potentially due to subretinal fibrosis involving the fovea
* BCVA ≥20/800 in the contralateral eye and better than the study eye
* ≥50 years of age
* Subfoveal choroidal neovascularization (CNV) of any type

Exclusion Criteria:

* Presence of other causes of CNV including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis
* Evidence of inflammation (Grade 1 or higher) in the anterior or posterior chamber
Improving Body Image in Middle Schoolers

The focus of this study is the development of a school-based multimedia product for the prevention of body dissatisfaction and unhealthy weight control behaviors in adolescents. The program is being designed for early adolescents, age 12-14, and will include information on maturation, healthy eating and exercise, skill building modules and media literacy awareness.


Eligibility Criteria:
Adolescents will be recruited from participating schools. Participants must be between the ages of 11-14 years.
Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple Sclerosis

It is a multicentric randomized and controlled study comparing a Scheme therapy program versus local practice in RRMS patients with anxiety. Patients will assist to twenty once-weekly group sessions with a 6-month follow up after the end of the programme. The main criteria is the impact of schema therapy on anxiety evaluated by the questionnaires at the end of the program and at the end of the 6-month follow-up.

A parallel arm randomized controlled trial comparing a group receiving Scheme Therapy plus current usual practice versus a group receiving current local practice only. The trial will take place in KASHANI Hospital (in Isfahan).Recruitment of the participants will be identified and recruited by the neurologists of the hospitals who take part in the programme, when they come for a medical examination.

After giving their informed consent, the patients will be entered onto the trial database and randomized to either the schema therapy or control using software allocated The intervention is the schema therapy focuses on the management of anxiety and is based on self-efficacy, self-management . It consists of 20 once-weekly sessions of 90 minutes (with a 15 Min break), with homework activities between the sessions. It is designed for groups of 8 people and will be delivered by two psychologists. The programme is standardized: Power Points presentations support each session and a detailed therapist manual and companion patient workbook accompany the programme.

For the ST group an evaluation will be administered pretest and post-test six months after the end of the schema therapy programme and at the same times for those in the control group. Socio-demographic and medical data, age, sex, level of education, marital status, number of children and professional status; date of diagnosis, disease type, level of disability (EDSS, Kurtzke, 1983) and information on relapses and treatments, are evaluated. The main criteria is the impact of schema therapy on anxiety evaluated by the BAI (beck anxiety inventory ) and level of cortisol at 6 month after the start program . Secondary criteria are: impact on the psychological dimensions assessed by Hospital Anxiety and Depression Scale (HADS), intensity of fatigue assessed by Fatigue Severity Scale (FSS), sleep quality evaluated by the Pittsburgh Sleep Quality Index(PSQI) depression by BDI (beck depression inventory ) and quality of life evaluated by (Multiple sclerosis impact scale) MSIS29.

Eligibility Criteria:
Inclusion Criteria:

* subject has relapsing remitting MS
* anxiety (score \>26 at the BAI scale)
* history of psychotic disorders
* history of cognitive deficiency
* use anti-depressant in the past 3 months
* history of relapse in the past 3 month
* expanded Disability Status Scale score less than 6
* ability reading and writing Persian
* Non hospitalized

Exclusion Criteria:

* history of psychotic disorders
* history of cognitive deficiency
* use anti-depressant in the past 3 months
* history of relapse in the past 3 month
Effects of Two Doses of Thylakoids on OGTT

This cross-over intervention study aims to investigate the effect of two doses of thylakoids to an oral glucose tolerance test (OGTT) on glucose and insulin homeostasis as well as appetite regulating hormones in healthy volunteers.

A minimum of twenty healthy volunteers are recruited to participate in an OGTT at three different occasions separated by one week. At two of the occasions a green leaf extract, thylakoids, is added to a glucose solution; 5 gram or 10 gram in randomized order. The third occasion, without added thylakoids, serve as control.

Blood samples are taken fasting and 15, 30, 45, 60, 90, 120 and 180 minutes after the glucose load.

Blood samples are analysed for p-glucose, p-insulin, p-C-peptide, p-ghrelin, p-CCK and p-GLP-1.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Adult
* Normal-weight and weight stable
* Not pregnant or breast-feeding
* No use of medication that can affect glucose- and insulin homeostasis (for example corticosteroids).

Exclusion Criteria:

* Diabetes,
* Impaired glucose tolerance and/or insulin resistance
* Anaemia
* Use of tobacco or drugs.