cyrilzakka/clinical-trials huggingface dataset:
Barrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers

This study is designed to perform a explorative search of the transcriptome to detect new circulating diagnostic sensitive and specific biomarkers in patients with Barrett's esophagus or esophageal adenocarcinoma.

By developing new tools for risk-assessing of Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) in a population at risk, the investigators expect that diagnosis can be done in an earlier stage resulting in an improved 5-year survival. A proof-of-concept RNA profiling study will be done in 20 BE and EAC patients where 2 biomaterials (tissue and plasma) and 2 RNA biotopes (micro RNA and messenger RNA) will be compared. Previously validated methodology on small RNA and messenger RNA capture sequencing on both tissue and plasma will be used to obtain high-quality data. Differential expression analysis will be done on tissue and plasma sample data. Additional in-depth data-mining will be done, amongst other focusing on structural information encoded in the transcriptome and building a multifeature classifier. These findings will be validated in a large validation cohort, followed by development of a clinical-grade quantitative Polymerase Chain Reaction (qPCR) test, ready for testing in an independent cohort.

Eligibility Criteria:
Inclusion Criteria:

* Barrett's Esophagus with length \> 3cm OR esophageal adenocarcinoma histologically proven
* Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
* Age over 18 years
* No other concurrent malignant disease
* No inclusion in other clinical trials interfering with the study protocol
* No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy
* Absence of any severe organ insufficiency
* No pregnancy or breast feeding
* Written informed consent

Exclusion Criteria:

* Pregnancy or breast feeding
* Active bacterial, viral or fungal infection
* Parenchymal liver disease (any stage cirrhosis)
* High risk of bleeding during biopsy (anticoagulants, esophageal varices)
* Esophageal squamous cell carcinoma
* Helicobacter pylori positive at the time of biopsy sampling
* Radiofrequency ablation of the oesophagus
* Psychiatric pathology capable of affecting comprehension and judgement faculty
Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face

The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe, effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or severe expression lines (wrinkles) in the upper third of the face. The main outcome was the change in appearance of the wrinkles two weeks (visit 3) after product application as compared with baseline assessment.

Ageing is a dynamic and unchangeable process involving all individuals and affecting the several organic systems. This process is expressed through multiple symptoms and signs, the wrinkles and flaccidity being the most common and visible ones.

In both developed and emerging countries, the interest in skin ageing is, to a greater extent, the result of the progressive increase in the absolute number and the proportion of people experiencing the ageing process in the last century. The psychosocial, as well as the physiological effects of the skin ageing raised a huge demand for a better understanding of this process and, in particular, of the effective interventions.

The use of the botulinum toxin type-A (BTX/A) for aesthetic indication emerged as a result of the clinical observation of those patients treated for facial different dystonia and who presented additional improvement of their expression lines.

The expression lines are most easily noted on the upper third of the face, where surgical treatments are fully invasive and show lesser noticeable results. The upper third of the face was targeted for BTX/A treatment and reported in several scientific literature articles as well succeeded.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 30 to 50 years old, inclusive.
* Mild, moderate or severe expression wrinkles.
* Patients who had understood and signed the Informed Consent Form.

Exclusion Criteria:

* Subjects treated with botulinum toxin on the upper third of the face within the previous 6-month period;
* Former implantation of permanent material and surgery (scars).
* Use of any anticoagulant agent up to 7 days prior to the investigational product application;
* Concomitant use of aminoglycosides or of any other drug that may impair in the neuromuscular transmission;
* Coagulopathies and local inflammation/ infection at the application site.
* Diseases which do impact on the neuromuscular function, such as: myasthenia gravis, Eaton Lambert Syndrome;
* Pregnancy or breast feeding, women with potential to become pregnant or who do not agree to use an effective contraception method (Pearl Index \< 1%);
* Allergy or known sensitivity to any of the components of the investigational drug;
* Subjects who were enrolled in other clinical trial for the last 12-month period prior to the present study, as per Resolution 251/97;
* Subjects who disagree with the study procedures, who do not sign the Informed Consent Form or who are not committed to participate in the trial.
Evaluation of the Irritation Potential of Products in Human Eyes.

To evaluate the human eye irritation potential of two test sunscreen formulation


Eligibility Criteria:
Inclusion Criteria:

* Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes.
* Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period.
* Willing to report any medications taken during the study.
* Willing to have the test materials instilled into the eyes and follow all protocol requirements.
* Have been informed and have given written consent to participate in the study.

Exclusion Criteria:

* Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome.
* Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, acquired immune deficiency syndrome (AIDs), severer rheumatoid arthritis. results as determined by the investigator.
* Must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
* Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.
Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction in size of localized areas of the body.

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm.

At investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Female or Male
* Minimum age of 18 years
* Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study.
* Post-menopausal, or on birth control with no plans to become pregnant for the duration of the study (female only)
* Minimum Body Mass Index of 20
* Visible fat in the area to be treated Area to be treated to measure at least 20.0mm in vertical fold, as measured with industry standard fat caliper
* Subject must be able to read, understand and sign the Consent Form
* Subject must adhere to the follow-up schedule and study instructions
* Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of initial weight)

Exclusion Criteria:

* Significant weight fluctuation (+/-10 lbs) in the past 6 months
* Taking weight-loss medications/supplements
* Participation in any other clinical study
* Cellulite treatment within 3 months of the treatment
* Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
* Prior treatment to the target area within the last 12 months
* Arteriosclerosis or weakened blood vessels
* Heart disease
* Thromboembolic disease
* Diagnosed or documented immune system disorders
* Bleeding disorders.
* Presence of uncontrolled hypertension
* Taking prescription anticoagulants
* History of keloid formation
* Malignant tumors in the target area
* Diabetes
* Any disease or condition that could impair wound healing
* Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles
* Infection in the target area
* Implanted electrical device(s)
* Pregnant or lactating
A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus

The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by an acute and rapid deterioration of liver function in a patient with previously well-compensated liver disease owing to the effects of a precipitating event. In this condition two insults act simultaneously, one being the preexisting liver injury (chronic liver disease) and the other acute injury which is responsible for the acute decompensation. HEV being a major factor responsible for this clinical entity and has a very high mortality rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can be an important drug in the treatment of these patients. Therefore the present study is designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.


Eligibility Criteria:
Inclusion Criteria:

* All ACLF due to HEV
* Consent to participate in trial and collection of blood.

Exclusion Criteria:

* Pregnant and nursing mothers.
* Severe anemia
* Other etiologies of ACLF (eg. Alcohol, drugs, reactivation of hepatitis B and hepatitis C, variceal bleeding, surgical intervention and sepsis)
* Hepatocellular carcinoma (HCC)
* Hepatorenal syndrome (HRS) at admission
* Presence of life threatening cardiovascular, respiratory and neurological disease
* Acquired Immunodeficiency Syndrome
* Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
* Refusal to provide consent to participate in the study
Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer

This study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.

This study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.

Two groups, parallel, randomly assigned clinical trials, long-term follow-up, repeated measurement (pre-test, 6th week, 12th week, 6th month, 12th month, five times in total), and a design of single center recruitment. The experimental group receiving an intervention comprised six weeks of light exposure combined with exercise training. The active control group receiving six weeks of stretching exercise. With a double-blind study design of participant blind and outcomes assessor blind, subjects were recruited from the thoracic surgery clinic and thoracic surgery ward of a medical center in northern Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed primary lung cancer or esophageal cancer, from the first stage to the third stage.
2. At least 20 years of age.
3. Able to communicate in Mandarin Chinese or Taiwanese.
4. Literate and free from cognitive disabilities.
5. The attending physician agrees to participate in the study.
6. Those who can connect to the Internet with mobile devices such as computers, mobile phones, and tablets, or those whose family members can assist in the operation.
7. Those with Karnofsky Performance Scale (KPS) greater than or equal to 70 points.
8. Those who are hospitalized for lung cancer or esophageal cancer lesion resection.

Exclusion Criteria:

1. Congestive heart failure.
2. Orthopedic diseases of the lower extremities that limit one's walking ability.
Pharmacogenetics in Non Small Cell Lung Cancer

Study the effect of genetic polymorphism in the membrane copper transporter 1 protein \[CTR1; encoded by the solute carrier family 31 member 1 gene (SLC31A1 gene)\] and its genetic expression levels on the clinical outcome of cisplatin-based regimen used in the treatment of Non-Small Cell Lung Cancer (NSCLC) in terms of :

* Treatment response : partial response (PR) / complete response (CR) and Progression-free survival (PFS)
* Treatment resistance : stationary disease (SD) or progressed disease
* Frequency and severity of regimen related toxicity

The cisplatin-based regimen is an effective treatment for advanced NSCLC, showing significant beneficial outcomes such as prolong survival, improve clinical symptoms, and improve quality of life (QOL) . Although platinum-based therapy shows several benefits, but the five-year survival rate still less than 20%.

Pt resistance is an inevitable occurrence with rare exception. Aside from germ cell tumors, metastatic solid tumors are generally thought to be incurable with cytotoxic chemotherapy due to the development of resistance and subsequent disease progression.

Despite the multifactorial nature of Cisplatin resistance, intracellular accumulation of Pt appears to be a major source of drug resistance . Reduced intracellular drug accumulation is one of the most consistently identified features of cisplatin-resistant cells.

Many evidences indicated that alteration of copper transporter protein 1 (CTR1) which is the major plasma membrane transporter responsible for platinum uptake, was associated with platinum sensitivity and toxicity.

Genetic polymorphisms of CTR1 also have effects to platinum treatment response. Therefore, CTR1 might be a potential prognostic factor for survival in cancer patients underwent chemotherapy and a treatment target for overcoming platinum resistance.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed with immunohistochemically and pathologically confirmed non- small cell lung cancer (NSCLC).
2. ECOG PS 0-2.
3. Chemotherapy naïve.
4. Age \>18 years.
5. Adequate bone marrow reserve.

Exclusion Criteria:

1. Presence of central nervous system metastases.
2. Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[ULN\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3.0 ULN or up to 5.0 UNL in the presence of hepatic metastases).
3. Inadequate renal function (creatinine \> 1.25 times ULN, creatinine clearance \< 50mL/min).
4. Serious comorbid systemic disorder incompatible with the study.
5. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
6. Pregnancy
Microecology and Host Immunity in Patients With Severe COVID-19 Infection

The purpose of this study was to analyze the relationship between the microbial community, host immunity and the prognosis of patients with severe COVID-19.

Methods: Bronchoalveolar lavage specimens of patients with severe COVID-19 were collected and studied to analyze the relationship between the composition of patients' microecology and the occurrence and development of disease.

Eligibility Criteria:
Inclusion Criteria:

* 1) Respiratory distress, respiratory rate ≥ 30 times/minute

  2) At rest, oxygen saturation ≤ 93%

  3）PaO2/FiO2 ≤300mmHg

  4) Shock

  5) Respiratory failure requires mechanical ventilation

  6) Complicated with other organ failure requires ICU monitoring and treatment

  7) Or in case of any of the following conditions, even if none of the above conditions is found, it is also managed as a critical case: ① pulmonary imaging shows that the lesion has significantly progressed more than 50% within 24-48 hours; ② Age\>60 years old; ③ Complicated with serious chronic diseases (including diabetes, hypertension, coronary heart disease, malignant tumor, structural lung disease, pulmonary heart disease and immunosuppressed population)

Exclusion Criteria:

* 1) Pregnant women

  2) Age\<18

  3) Mental disorders

  4) Patients with long-term mechanical ventilation for more than 60 days

  5) Disagreement group researcher
A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects with NAMD

The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained prior to study participation;
2. Male or female ≥ 50 years of age at the time of signing the informed consent;
3. Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid involving the fovea;
4. BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline.

Exclusion Criteria:

1. Ocular disease:

   * Any concurrent intraocular condition/systemic disease in the study eye at screening or baseline that, in the judgment of the investigator, may cause the participant fail to respond to the treatment or confuse the interpretation of study results;
   * Total lesion area(including blood, atrophy, fibrosis, PED and neovascularization)\> 12 optic disc area (DA) on FFA;
   * Subretinal hemorrhage area \> 50% of the total lesion area, or subretinal hemorrhage area involving macular fovea ≥ 1 DA;
   * Fibrosis or atrophy area \> 50% of the total lesion area, or involving the fovea; Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg after standard treatment);
   * Presence of active intraocular or periocular infection or inflammation;
2. Ocular treatment:

   * Anti-VEGF or anti-complement therapy in the study eye within 90 days prior to baseline;
   * Fundus laser photo-coagulation in the study eye within 90 days prior to baseline;
   * Photodynamic Therapy (PDT) in the study eye within 90 days prior to baseline;
   * History of vitreoretinal surgery, penetrating keratoplasty in the study eye;
3. General condition or treatment:

   * Uncontrolled hypertension (defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg after standard treatment);
   * HbA1c \> 8% within 28 days prior to baseline; Systemic anti-VEGF drug and anti-complement drug therapy within 90 days prior to baseline;
   * History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye, povidone-iodine;
   * Pregnant or lactating women; Inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow the trial protocol), as judged by the investig.
Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain

\*Aim of the Work This study aims to assess the efficacy of intravenous injection of dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women undergoing cesarean section.

\*Research Hypothesis: In women undergoing cesarean section, intravenous injection of dexamethasone prior to spinal anesthesia may reduce post-cesarean section pain.

\*Research Question: In women undergoing cesarean section, does injecting intravenous dexamethasone prior to spinal anesthesia reduce post-cesarean section pain?

Eligibility Criteria:
* Inclusion Criteria:

  * A gestational age of 38 weeks or more and planned for elective cesarean section.
  * Living fetus.
  * Any number of previous cesarean section.
  * Intact amniotic membranes.
  * No history of bleeding tendency.
* Exclusion Criteria:

  * Refuse to participate after counseling.
  * Contraindication to spinal anesthesia (coagulopathy significant hypovolemia systemic or local sepsis - increased intracranial pressure - local anesthetic or fentanyl allergy).
  * High risk pregnancies as pre-eclampsia, any medical disorder (diabetes mellitus, cardiac disease or and thyroid disease).
  * Contraindication to corticosteroids e.g. systemic fungal infection
  * Steroid medication one week before the operation.
  * Chronic pain or daily intake of analgesic.
  * Abnormal placentation e.g. placenta previa.
  * Intrauterine infection.
Three Types of Papilla Incision in Periodontal Surgery

Three types of papilla incision in periodontal reconstruction techniques will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with periodontal disease.
* Active residual pockets associated with intraosseous defects that did not resolve with non-surgical treatment after 1 year of maintenance.
* Intraosseous lesions with probing depth greater than 5 mm or extension of the radiographic defect greater than 4 mm.
* Plaque index and bleeding index less than 30%.

Exclusion Criteria:

* Systemic disease that contraindicates periodontal surgery.
* Pregnant women.
* Third molars or teeth with incorrect endodontic or restorative treatment.
Meal Texture and Satiety

The aim of the present study is to compare the nutritional compensation between iso-caloric meals of various textures (liquid vs solid) in health young adults.

The present study will compare the potential energy intake compensations, appetite feelings response, food reward variations and satiating responses after the ingestion of three different lunch meals: i) one classical cooked meal; ii) one iso-energetic meal consumed using a pre-prepared liquid meal; iii) one iso-energetic meal consumed using a prepared liquid meal. This will be the first study to assess all these nutritional factors after such meals.

Eligibility Criteria:
Inclusion Criteria:

* being aged 18 to 25 years old
* Being normal weight with a BMI between 20 and 25 kg/m²
* Being registered with a social security number

Exclusion Criteria:

* Eating disorders
* Specific food allergies or habits
* being under diet