cyrilzakka/clinical-trials huggingface dataset:
Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma

This is a randomized, prospective, multicenter study.

This is a randomized, prospective, multicenter study. The aim of this study was to compare the changes of body weight,survival,toxicity,quality of life and opportunistic infection frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after chemoradiotherapy with or without enteral nutrition therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years old
* male or femalePathologically or cytologically proven esophageal squamous cell carcinoma
* Clinical stage II or stage III
* PG-SGA≧2
* Karnofsky performance score(KPS) ≧70
* Estimated life expectancy of at least 12 weeks
* Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times upper limit of normal,bilirubin normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Patients have good compliance to treatment and follow-up of acceptance
* Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value
* the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications

Exclusion Criteria:

* Patients with severely bowel function impaired or can not tolerate enteral nutrition
* Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted
* Patients have no risk of malnutrition
* Patients have severe malnutrition (weight loss \>10% or \<30 g/L, BMI\<18.5 kg/m2 or hemoglobin\<90 g/L before the treatment
* Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction
* Patients can not tolerate chemotherapy and radiotherapy
* Patients who have distant metastasis
* The primary tumor or lymph node already received surgical treatment (except for biopsy);
* Patient who received radiotherapy for primary tumor or lymph node;
* Patient who received chemotherapy or immunotherapy;
* Patient who suffered from other malignant tumor;
* Patient who have taken other drug test within 1 month;
* Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
* Subject with a severe allergic history or idiosyncratic;
* Subject with severe pulmonary and cardiopathic disease history;
* Refuse or incapable to sign the informed consent form of participating this trial;
* Drug abuse or alcohol addicted;
* Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct;
Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans

Exposure to heat stress can compromise the physiological and cognitive function and be life threatening, particularly in a military setting. Various strategies of precondition to heat stress that have been explored in the past proved to be inapplicable. We aim to examine the influences of Astaxanthin supplementation as a preconditioning strategy to heat stress in a human model using a heat tolerance test. This will be achieved by a double-blind, placebo controlled supplementation trial, exposing human subjects, before and after consuming Astaxanthin or a placebo, to a controlled heat strain environment, while performing moderate exercise in a heated chamber.

34 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination and an interview with a nutritionist to assess their dietary intake of Astaxanthin. They will then undergo 3 days of training on the cognitive testing software.

During the first stage, while consuming an Astaxanthin free diet, the subjects will participate in the physiological tests:heat tolerance test (HTT), thermo-neutral test (TTT) and maximal oxygen consumption test (VO2max) on 3 separate days.

During the second stage, the subjects will be randomly and blindly assigned to either the placebo or the Astaxanthin supplementation arms, and undergo 35-40 days of supplementation.

Physiological testing of the second stage will take place between the 31st and 35th (up to 40th - optional) days of supplementation and will include HTT, TTT and VO2max on 3 separate days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy civilian volunteers.
* Aged 20-30 years.
* Without known medical illness or medication use.

Exclusion Criteria:

* The existence or suspicion of existing cardiac or respiratory disease.
* Hypertension.
* Diabetes.
* Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
* Infectious disease 3 days prior to the experiment.
Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease

The current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease that requires intravenous iron maintenance therapy.

This will be a multicenter, observational, prospective registry collecting long-term (12-month) safety, tolerability, and laboratory data. Subjects will be screened for inclusion criteria if on hemodialysis (HD), peritoneal dialysis (PD) or have non-dialysis dependent (NDD) chronic kidney disease (CKD).

Treatment-emergent adverse events (adverse events starting from the time of the 1st dose of Venofer administered on study) will be collected via site entry of data into a web-based system. Each research investigator will be responsible for entering adverse event information on the appropriate clinical research form as well as reporting such events to the sponsor.

Number of Subjects: 50 evaluable subjects (i.e., took at lease one dose of Venofer and have safety data recorded at the 12 month time point).

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 2 to less than or equal to 17 years
* Subjects must have a diagnosis of either NDD-CKD, PD-CKD or HD-CKD
* Dialysis patients must be on a stable periotoneal (PD) or hemodialysis (HD) regimen for 1 month
* Patient agrees to participate in the registry (i.e., provide adverse event information) for 12 months

Exclusion Criteria:

-
Efficacy of a Novel Hemostatic Powder in GI Bleeding

Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study is to determine effectiveness of Hemospray™ on short and medium term in different clinical situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of the application of hemostatic powder in routine clinical practice studying in a large sample of patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 and over who need the use of Hemospray® under their care in an emergency.
* Upper gastrointestinal hemorrhage.
* Patients who received the information note of the study and agreeing to participate (non-oral opposition gathered in the patient's medical record)

Non Inclusion Criteria:

* Patient under guardianship, curatorship.
* Pregnant woman.
Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis

To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis.

Lumbar canal stenosis is a disease caused by the compression of the dural sac and nerve root due to various factors such as hypertrophy of the ligamentum flavum (LF), facet joint hypertrophy, disc herniation, and spondylolisthesis, resulting in low back pain, leg pain with or without numbness, intermittent claudication, and bladder and bowel dysfunction in which intermittent neurogenic claudication is the main feature (1, 2).

Traditional surgical approaches include open laminotomy decompression, foraminotomy, discectomy, and fusion. Conventional open lumbar decompression has a long history and has the advantages of adequate decompression and clear visualization of neural structures, while surgical invasiveness and extensive stripping of paraspinal muscles and soft tissues may lead to a series of problems such as postoperative low back pain, spinal instability, and prolonged hospital stay and time to return to normal life after the operation (3).

Minimally invasive spine surgery has become increasingly popular in recent years. Unilateral bi-portal endoscopy (UBE) was proposed by Heo in 2017 to treat degenerative lumbar spinal diseases with less damage to the paraspinal muscles (4).

Minimally invasive decompression was introduced as a tissue-sparing alternative and applied to lumbar central stenosis. Minimally invasive decompression revealed good clinical outcomes comparable to those of conventional surgery (5, 6). It also showed a reasonable operative time, shorter hospital stay, and reduced blood loss, time to mobilization, postoperative pain, and narcotic use when compared to that seen with conventional surgery (7).

However, it presents some disadvantages, including poor visualization, difficulty of instrument manipulation, potential to induce inadequate decompression, and longer operative time than other minimally invasive surgeries (8).

Eligibility Criteria:
Inclusion Criteria:

* Patients with acquired degenerative lumbar canal stenosis. Age \>40 years. Single or Double level stenosis

Exclusion Criteria:

* Post-traumatic lumbar canal stenosis. Previous spine surgery. Multi-level stenosis more than 2 levels. Associated instability e.g. spondylolisthesis. Spinal diseases (e.g., ankylosing spondylitis, infection, spine tumor, fracture, or neurologic disorders).
Ologen (OculusGen)-Glaucoma MMC Control in Pakistan

The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.

1. Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
2. Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with OculusGen implant or trabeculectomy with mitomycin-C.
3. Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over.
* Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
* Subject able and willing to cooperate with investigation plan.
* Subject able and willing to complete postoperative follow-up requirements.
* Subject willing to sign informed consent form.

Exclusion Criteria:

* Known allergic reaction to mitomycin-C or Bovine collagen.
* Subject is on warfarin and discontinuation is not recommended.
* Normal tension glaucoma.
* Participation in an investigational study during the 30 days preceding trabeculectomy.
* Ocular infection within 14 days prior to trabeculectomy.
* Pregnant or breast-feeding women.
A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia

This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2 subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients who have relapsed or are refractory after at least one cytarabine/anthracycline containing regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2 intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4 cycles of therapy, patients in Arm A who achieve hematologic response may continue additional cycles until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients with histologically or cytologically documented acute myelogenous leukemia appropriate for cytarabine therapy including:
* Arm A: Patients who have not received prior standard induction chemotherapy, considered unsuitable for standard induction therapy
* Arm B: Patients who have failed their 1st or greater line of standard induction chemotherapy (primary refractory) or patients who originally achieved a complete response but are currently in first or greater relapse
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to NCI-CTC AE Grade \</=2
* Adequate hepatic and renal function
* Patient must be willing to submit the blood sampling and bone marrow sampling for PK and PD analyses and exploratory biomarkers

Exclusion Criteria:

* History of allergic or toxic reactions attributed to cytarabine or a history of allergic reactions to components of the formulated product
* Current evidence of CNS leukemia
* Any severe and/or uncontrolled medical condition or other conditions that could affect the participation in the study
* Pregnant or breastfeeding women
* HIV-positive patients receiving combination anti-retroviral therapy
Smartmesh Technology in Pelvic Floor Repair Procedures

Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.

Between January 2013 and December 2016, in the participating centers, all adult women who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis are eligible. Collected data are about the peri-operative period and the data available at the last consultation.

Eligibility Criteria:
Inclusion Criteria:

* Over 18
* woman who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis
* informed and not opposed to the use of her data

Exclusion Criteria:

* Opposed to the use of her data
Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease

The aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.

A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain, pathological corneal epithelium regeneration, inflammation reaction and seriously visual loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells require immune suppressive medications, it can cause side effects in the body. Over the past 10 years, the clinical trials of application of cultured autologous oral mucosal epithelial cell sheet to treat LSCD have been emerged as a promising strategy in many countries. However, little study has been reported in China. This study investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease in China.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged\>=18 years old
* Normal intraocular pressure
* Normal Eyelid
* No cataract and retinal disease
* No ulcers and tumor in the mouth

Exclusion Criteria:

* Severe Systemic infection
* History of acute phase of ocular and oral inflammation
* History of hyper sensibility or allergy to antibiotics or serum
* Women who are or may be pregnant
* Patients with infectious diseases
* Patients with other complications
Sleep's Influence on the Treatment of Intrusive Emotional

Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent psychiatric disorders following trauma. Exposure therapy is amongst the most successful treatments of PTSD that is recommended by most of the current national and international guidelines. The current study aims to test whether sleep as adjunct to written exposure sessions, a type of exposure- based treatment for PTSD, may boost the effectiveness of the therapy.

Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent psychiatric disorders following trauma. Exposure therapy is amongst the most successful treatments of PTSD that is recommended by most of the current national and international guidelines. However, not all patients benefit equally and only about 50% show sustained response. There is thus room for improvement in terms of (i) better understanding who benefits from this type of therapy and (ii) possible ways of augmenting existing trauma-focused therapies. The current study aims to contribute to these endevours. Specifically, the study aims to test whether sleep as adjunct to written exposure sessions, a type of exposure- based treatment for PTSD, may boost the effectiveness of the therapy.

Eligibility Criteria:
Inclusion Criteria:

* DSM V criteria of PTSD (at least moderate symptoms in two categories)
* Currently receiving Written Exposure Therapy at one of the psychotherapy centers at the Psychiatric University Clinic (PUC).
* Not more than moderate alcohol consumption (not more than 5 alcoholic drinks/week).
* Ability to understand the study instructions

Exclusion Criteria:

* Travel over \> 3 time zones in \< 3 months
* head injury
* shift work
* current substance abuse
* neurological disease
* drug addiction
* Current suicidality

Specific exclusion criteria for the fMRI:

* Acute psychotic symptoms
* Pregnancy
* Claustrophobia
* Magnetic resonance imaging incompatibility:
* Cardiac pacemaker or other metallic implants (e.g. metallic cardiac valve, insulin pump)
* Metallic foreign particles (e.g. after bullet wound, shell splinter, clips, metal prostheses)
CT-95 in Advanced Cancers Associated with Mesothelin Expression

This is a Phase 1 open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.

This Phase 1 dose escalation trial will enroll subjects into one of approximately 8 dose escalation cohorts to assess safety, tolerability and to determine the maximum tolerated dose or recommended dose. CT-95 is to be administered once weekly (Q1W) for each cycle. A cycle is defined as 28 days. Subjects will be dosed until documentation of disease progression, unacceptable toxicity, or subject/physician decision.

Eligibility Criteria:
Inclusion Criteria:

* ECOG 0 or 1
* Subjects with evaluable disease per RECIST 1.1 or mRECIST
* Subjects with adequate organ function.
* Subjects with advanced cancers associated with mesothelin expression

Exclusion Criteria:

* Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study.
* Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy
* Concurrent participation in another investigational clinical trial.
* Evidence of leptomeningeal disease
An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer

AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Eligibility Criteria:
Inclusion Criteria:

* At least 20 years of age
* Patients who were in the AZD9291 Early Access Program
* Received at least one dose of AZD9291 treatment as mono-therapy, supported by available source documents
* Patient who discontinued the single use of AZD9291, had disease progression, or died under AZD9291 treatment, whichever comes last, during the period from October 01, 2015 to December 31, 2018
* Patients agree to provide the written informed consent or the informed consent is waived by IRB.

Exclusion Criteria:

• Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC
Reproducibility Study of Overactive Bladder Symptom Score [OABSS]

The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms OAB for 3 months or longer
* At least 1 urgency episode in last 3 days
* Symptoms of OAB as verified by 3-day micturition diary prior to Visit 1, defined by:

  * Number of micturition per day ≥8
  * Number of urgency episodes in 3 days ≥1

Exclusion Criteria:

* Significant stress incontinence or mixed stress/urge incontinence
* Subjects with indwelling catheters or practicing intermittent self-catheterization
* Symptomatic urinary tract infection, chronic inflammation
* Diabetic neuropathy
* Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
* Participation in any clinical trial in 30 days