cyrilzakka/clinical-trials huggingface dataset:
Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01

Ratiotherapy alone is the current standard treatment for elderly esophageal or esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly patients. This study aimed to assess the efficiency and safety of simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric cancer patients


Eligibility Criteria:
Inclusion Criteria:

* ≥70 years
* Esophageal or Esophagogastric cancer
* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as IIa-IVb (UICC 2002, IVb only with supraclavicular or celiac trunk lymph nodes metastasis)
* Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
* No distant metastasis other than supraclavicular lymph nodes
* No prior history of thoracic radiation
* Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
* Informed consent

Exclusion Criteria:

* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
* With any distant metastasis out of regional lymphatic drainage or in liver,lung,bone,CNS,etc
* History of allergic reactions attributed to similar chemical or biologic complex to S-1
* With esophageal fistula, perforation, cachexia prior to treatment
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* Pregnant or lactating females
The Frequency Forward Head Posture in Subjects With Temporomandibular Disorder

The aim of this study was to verify the frequency of the forward head posture in subjects with temporomandibular disorder and to compare them with control group

Postural habit is defined as "the attitude of the body" being characterized as good when the parts of the body muscles and bones are lined up and work together in a harmonious form protecting the body of injury or gradual deformity and independently the attitude. The bad posture is a bad habit, but it can be which results in the disagreement of some parts of the body. These are at risk of injury or pain due to and increased tension that the disagreement imposes to the support structures. Several study confirm this occurrence relating that this the attitude can alter itself principally if a discomfort occurs. When it occurs there will be the installation of alterations, limitation of movements or even deformity, leading it to the development of an abnormal of posture of the body which will be able to reduce the functional capacity of various structures and organs of the human body.

The forward head posture is a common abnormality in cervical spine that can contribute to perpetuation the trigger points in muscles of the head as well as some kinds of temporomandibular disorder. It was suggested its influence in the treatment of patients with orofacial pain and TMD the FHP may occur a result of an acute trauma or if develop itself gradually because of an inadequate position.

Eligibility Criteria:
Inclusion Criteria:

Study group

The criteria of inclusion of the individuals for this group were:

* Individuals whose main complaint were pain in the muscles of the chew or the TMJ
* To present pain of the muscle or to articulate during the functional tests
* Maximum opening interincisal equal or minor than 40 mm

Crontrol group

The criteria of inclusion of the individuals for this group were:

* Individuals who underwent routine dental treatment
* Individuals without TMD complaint
* Maximum opening interincisal bigger than 40 mm

Exclusion Criteria:

* There are not
Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis

Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

Eligibility Criteria:
Inclusion Criteria:

• Chronic or recurrent pouchitis

Exclusion Criteria:

* Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
* History or current evidence of colonic or abdominal abnormalities.
* Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.
The Effect of Orthopedic Face Mask Use on Head Posture and Pharyngeal Airway

The aim of this study was to evaluate the changes in head posture, position of the hyoid bone, pharyngeal airway and cervical posture after the use of Petit type face mask in patients with skeletal class III malocclusion (ANB angle \< 0) with ongoing growth.

No other study was found in the literature in which head posture, cervical posture, and hyoid bone position were evaluated after the use of a face mask and compared with a control group consisting of patients of the same age group and the same malocclusion.

All radiographic assessments, including cephalometric, pharyngeal airway and craniocervical measurements were performed by the same researcher and she was blind to all the treatment details, orthodontic records, and information of the subjects to prevent bias. Lateral cephalometric radiographs were taken digitally with an X-ray unit (OP300; Instrumentarium Dental, Tuusula, Finland) according to the manufacturer and same technician. Subjects were positioned at the natural head position, teeth in centric occlusion, and lightly closed lips for lateral cephalometric radiographs. Skeletal development of individuals was evaluated using cervical vertebra maturation method (Ref: Bacetti T., An Improved Version of the Cervical Vertebral Maturation (CVM) Method for the Assessment of Mandibular Growth. Angle Orthod.). The skeletal development of individuals was evaluated using the cervical vertebra maturation method and it was determined that all patients were in the prepubertal stage (CS1-CS3). (Ref: Cevidanes L., Comparison of two protocols for maxillary protraction: bone anchors versus face mask with rapid maxillary expansion. Angle Orthod.)

Eligibility Criteria:
Inclusion Criteria:

* For the study group it is as follows:

  1. Patients with skeletal Class III association (ANB \< 0°)
  2. Maxillary insufficiency patients
  3. Patients with ongoing growth development
  4. Patients who have used a 'Petit type face mask' for anterior positioning of the maxilla
* For the control group it is as follows:

  1. Patients with skeletal Class III association (ANB \< 0°)
  2. Maxillary insufficiency patients
  3. Patients with ongoing growth development
  4. Patients who have not had any orthodontic treatment

Exclusion Criteria:

1. Patients with a congenital anomaly or a craniofacial deformity
2. Patients who have undergone orthodontic treatment
3. Patients with tooth extraction or tooth loss
4. Patients with a history of trauma
5. Patients who have completed growth development (patients with Ru on wrist film)
Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment

Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma previously exposed to taxanes for early stage.

The primary objective of the study is to determine the median time to progression achieved with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic breast cancer HER2 negative, stage IIIb/IV
* Previous history of early disease (stage I-IIIb), surgically resected and treated with standard chemotherapy for at least 12 weeks at which included a taxane or ixabepilone
* Patients must have progressed in the 36 months after treatment with taxanes or ixabepilone.
* Age ≥ 18 years
* Given written informed consent
* Index of Eastern Cooperative Oncology Group (ECOG) of 0 or 1
* Patients must have recovered from toxicities related with previous treatment (CTC ≥ 1)
* Measurable or evaluable disease (RECIST 1.1)
* Adequate bone marrow function
* Adequate hepatic function
* Adequate renal function
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Breast cancer patients initially diagnosed with local disease advanced or metastatic disease.
* Patients who have previously received cytotoxic therapy Hormone therapy permitted if the patients have interrupted it at least two weeks before the start of the study treatment.
* Major surgery or significant traumatic injury during the 4 weeks prior to study treatment or patients who may require major surgery during the assay.
* Brain metastases or leptomeningeal uncontrolled.
* Serious medical condition and / or not properly controlled (unstable angina, lung function severe impaired, uncontrolled diabetes, active serious infection,liver disease, HIV seropositivity, active bleeding diathesis)
* Other malignancies in the last three years, except: cervical carcinoma in situ, basal cell carcinoma or squamous cell skin carcinoma,that have been properly treated
* Patients who are pregnant or breastfeeding, or adults with reproductive capacity wich are not using effective contraception.
* Patients receiving chronic treatment with systemic corticosteroids or other immunosuppressive drugs (except corticosteroids with a daily dose equivalent to prednisone ≤ 20mg on a stable dose regimen one minimum of 4 weeks prior to study entry. Topical and inhaled corticosteroids are allowed
* Active alcoholism or drugs addiction documented.
* Prior history of noncompliance with medical regimens
* Patients who do not want or can not comply with the study protocol
Gut Microbiota, Anastomotic Leak and Colorectal Cancer

This is a prospective study evaluating the relation between the gut microbiota composition, intestinal healing after colorectal surgery and colorectal cancer behavior.

Our hypothesis is that the gut microbiota composition could predict poor intestinal healing in colorectal surgery, and that the gut microbiota might have an impact on colorectal cancer clinical behavior and may predict disease outcomes.

No more details required

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* CRC diagnosis
* Upcoming colonic and/or rectal resection with/without anastomosis
* Individuals without diseases of the colon and rectum (healthy controls)

Exclusion Criteria:

* Pregnancy
* Previous stoma
* Bowel surgery in the last 4 weeks prior to the surgery

Secondary objectives, inclusion criteria are as follows:

* Age 18 years and older
* Rectal cancer diagnosis with histopathological confirmation
* Abdominoperineal resection with terminal colostomy
* Expectative non-surgical management ("Watch and wait approach")
Evaluating Dynamic Arterial Elastance in Septic Shock Patients.

Assess the effectiveness and safety of using dynamic arterial elastance as a tool for weaning vasopressor support in patients with septic shock, compared to a control group

An open-label, randomized controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using dynamic arterial elastance (EaDyn) as a tool to guide vasopressor weaning can reduce the duration of vasopressor support. Eligible patients will be randomly assigned to either the EaDyn weaning arm or the mean arterial pressure (MAP) weaning arm in a 1:1 ratio. Blinding of participants and investigators will not be possible due to the study's methodology. The analysis will be conducted on an intention-to-treat basis.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* Admission to the ICU.
* Septic shock defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
* Hypotension requiring vasopressor support to maintain a MAP ≥ 65 mmHg.
* SOFA score ≥ 4.
* Vasopressor support duration ≥ 4 hours.
* Patients requiring mechanical ventilation.
* Patients who have reached the hemodynamic stabilization phase and are ready to begin the vasopressor weaning process with norepinephrine, defined as: mean arterial pressure (MAP) \> 75 mmHg, cardiac index (CI) \> 2.5 L/min/m², and lactate level \< 2 mmol/L.

Exclusion Criteria:

* Pregnant individuals.
* Hemodynamic instability due to cardiac arrhythmias.
* Hepatic cirrhosis.
* Kidney or liver transplant.
* High probability of mortality within 24 hours, according to medical judgment.
* Left ventricular ejection fraction (LVEF) less than 50%.
* Right ventricular dysfunction, defined as a TAPSE (Tricuspid Annular Plane Systolic Excursion) measurement of less than 1.6 cm.
* Patients spontaneously breathing.
A Research Study To Compare Two Kinds Of Daily Headache

Chronic daily headache has been classified into several categories. One category is of sudden onset and is called New Daily Persistent Headache (NDPH). Another category of daily headache evolves gradually and is called Transformed Migraine (TM). This research study is being conducted to compare people with these two kinds of daily headache in order to improve our understanding of these conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 14-65, inclusive
* Diagnosis of NDPH or TM according to the Silberstein-Lipton criteria.
* Ability to read and understand an informed consent form and study procedures

Exclusion Criteria:

* Pregnancy
* Subjects with any disease or condition that would result in unreliable data or confound the data obtained for this study, as determined by the principal investigator.
Digital Storytelling in Symptom Management Pediatric Oncology

The aim of this clinical study is to evaluate the effectiveness of the digital storytelling method in symptom management in children diagnosed with oncology. It will also provide information about children's experiences with Digital Storytelling and the use of the method. The main questions it aims to answer are:

* Is there a difference between the anxiety scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the fatigue scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the nausea scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the pain scores of children who applied and did not apply the Digital Storytelling Method?

Participants:

Complete the first stage data forms. Visit the clinic every 7-15 days for the digital storytelling process, which consists of 4 stages. After the storytelling process is completed, have a process evaluation meeting with the researcher.

Participants; Enterprise Group,

1. Interview (Week 1); Meeting the child, conducting a qualitative interview for needs analysis and introducing the forms
2. Interview (Week 2); Finding a digital story topic
3. Interview (Week 3); Writing a story on the specified topic
4. Interview (Week 4); Converting the story into digital form
5. Interview (Week 5); Showing the created story
6. Interview (Week 6); Conducting a qualitative interview regarding the digital storytelling process.

Each meeting will be held in 1-week periods. Primary outcome tools will be applied as pretest and posttest once in the 1st and 6th interviews, and twice in the other interviews.

Control Group;

1. Interview (Week 1); Meeting the child, introducing and applying the forms
2. Interview (Week 6); Conducting a qualitative interview regarding the digital storytelling process. Showing the videos prepared by the children in the initiative group. Application of primary outcome tools.

Eligibility Criteria:
Inclusion Criteria:

* 7-18 years old,
* Having received at least 1 cure of treatment,
* Completed the induction phase and is in the consolidation phase,
* Children who and their parents agree to participate in the study.

Exclusion Criteria:

* who cannot speak Turkish,
* Having a secondary chronic disease
* Having a second disease that will affect the cognitive process,
* Children/adolescents who cannot complete the 4 stages of the digital storytelling process.
* Children/adolescents who cannot complete the 4 stages of the digital storytelling process.
* Children/adolescents who take a break of more than 3 weeks between storytelling processes.
Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters.

Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 15 subjects will be enrolled.

The specific aims include:

Primary aims:

1. Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
2. Examine the efficacy of salsalate in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score.

Secondary aims:

1. Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years;
* Diagnosis of schizophrenia or schizoaffective disorder;
* Stable dose of the current antipsychotic drug for at least one month;
* Well established compliance with outpatient treatment per treating clinician's judgment;
* Able to complete the cognitive assessment battery (must be English speaking);
* Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.

Exclusion Criteria:

* Inability to provide informed consent;
* Current substance abuse;
* Psychiatrically unstable per treating clinician's judgment;
* Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases;
* Currently on immunosuppressant medication including oral steroids;
* Use of anti-coagulants (heparin, LMWH, warfarin, cilostazol, clopidogrel, dabigatran);
* History of chronic infection (including, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition;
* Experienced asthma, urticaria or allergic type reaction after taking aspirin, salsalate, or other NSAIDS;
* Pregnancy or breastfeeding;
* Pre-existing chronic tinnitus.
* Known hypersensitivity to salsalate.
The Metabolite Identification and Material Balance Study of SP2086

The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.

All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index(BMI) between 19 and 25 Kg/m2,and weight ≥50kg.
* Lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible.
* Had signed the informed consent himself or herself voluntarily.

Exclusion Criteria:

* Has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.).
* Has a history of allergy or intolerance to SP2086 OR other DPP-IV.
* The subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks.
* Did not take effective contraceptive measures or planning of the subjects in half a year.
* Researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.
National Survey on Dyslipidemic Patients

The purpose of this observational study is to describe the time to lipid-lowering drug implementation in the management of dyslipidemic patients, according to the cardiovascular risk level.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dyslipemia made less than 2 years
* Treated by a lipid-lowering drug
* Agree to take part in the survey

Exclusion Criteria:

* Patient included in a clinical trial
Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity

The aim of the project is to decrease the inflammatory status of pregnant women with preterm premature rupture of membranes to delay the initiation of labour that would inevitably lead to premature delivery. The main objective is to measure the mean duration between the initiation of the treatment and delivery in the two groups treated either with MAG-DHA or with the placebo.

This randomized controlled trial will be conducted in two hospitals in the province of Quebec (CHUS, CHUQ- Site mère-enfant Soleil).

Patients between 24 and 33 weeks of gestation with a diagnosis of preterm premature rupture of membranes (PPROM) who meet all inclusion and none of the exclusion criteria will be approached to participate. Once they have signed the IFC, participants will be randomized and begin a supplementation with either MAG-DHA or the placebo until delivery or for up to 2 weeks (14 days). A total of 70 patients will be recruited.

Principal outcome: To compare the difference in duration between the start of treatment and delivery between the group receiving MAG-DHA and the group receiving placebo.

Secondary outcomes: 1) Evaluate the difference in neonatal outcome between children in the MAG-DHA group and those in the placebo group. 2) Determine the inflammatory status of the patients associated with the exposure to either MAG-DHA or the placebo.

This regimen could potentially represent an innovative approach in the management of women with a diagnosis of PPROM.

Eligibility Criteria:
Inclusion Criteria:

* PPROM diagnosis, gestational age between 24 and 33 weeks of gestation.

Exclusion Criteria:

* multiple pregnancy, placenta previa, preeclampsia, retroplacental hematoma, chorioamnionitis, intrauterine growth retardation, severe fetal malformations