cyrilzakka/clinical-trials huggingface dataset:
The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer

This is the prospective, observational cohort study (G-Distress) to explore the associations of psychological stress with treatment and prognosis of gastric cancer. The participants including the patients diagnosed with gastric cancer who received surgery, chemotherapy and immune checkpoint inhibitors.


Eligibility Criteria:
Cohort 1

Inclusion Criteria:

1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1
2. Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
3. R0 gastrectomy with D2 lymphadenectomy
4. Receiving adjuvant chemotherapy

Exclusion Criteria:

1. History of chemotherapy, radiotherapy, immunotherapy or target therapy
2. Multiple primary tumors
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
4. Unavailable for R0 resection and D2 lymph node dissection.
5. Patients with stage IV gastric cancer

Cohort 2

Inclusion Criteria:

1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1
2. Be proven to be primary adenocarcinoma of gastric cancer and staged III-IV by pathological evidences
3. Receiving gastrectomy
4. Receiving preoperative chemotherapy

Exclusion Criteria:

1. Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
2. Multiple primary tumors
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
4. Unavailable for gastrectomy

Cohort 2

Inclusion Criteria:

1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1
2. Be proven to be primary adenocarcinoma of gastric cancer and staged IV by pathological evidences
3. Unavailable for gastrectomy
4. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1

Exclusion Criteria:

1. Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
2. Multiple primary tumors
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
Measuring Herpes Zoster and PHN Associated Burden of Illness and Health Care Utilization Costs in Thailand

Total 7 institutions will be recruited i.e. Clinical Infectious Disease Research Unit Department of Clinical Tropical Medicine, Faculty of Tropical Medicine Mahidol University,Bamrasnaradura Infectious Disease Institute

,Pramonkutklao Hospital,Rajavithi Hospital,NationalCancerInstitute,Institute of Dermatology,Raj Pracha Samasai Institute

OBJECTIVES

* Measure the burden of illness due to herpes zoster (Zoster) and post-herpetic neuralgia (PHN) (severity and duration);
* Assess the quality of life (QoL) and quality adjusted life years (QALY) lost due to Zoster and PHN;
* Describe health care resource utilization associated with Zoster and PHN;
* Describe the direct and indirect costs per case of Zoster and PHN

This will be a prospective cohort study of patients presenting with Zoster rash in 7 specialized institutions in Thailand.

Subjects will be entered in the cohort at the time of presentation with Zoster rash. After the baseline assessment (day 0) that will be conducted at the investigator's office there will be 4 assessments (prospective part of the study) that will be conducted at day 7, month 1, month 3 and month 6.

We expect that there will be approximately 150 patients included in the study cohort. Cohort assembly will take place between April 2007 and October 2007.

The study will be conducted in 3 groups

Eligible patients for each group will include

* Group A: Both male and female patients ≥ 50 years of age with Zoster rash.
* Group B: Both HIV infected male and female patients ≥ 20 years of age with Zoster rash.
* Group C: Both Oncology male and female patients ≥ 20 years of age who on chemotherapy with Zoster rash.

Key exclusion criteria includes patient who refuses to sign informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Physician confirmed diagnosis of Zoster rash
* of onset of Zoster rash must be documented in the patient's chart.
* Patient is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent.
* Patient will be available for the study follow up period

Exclusion Criteria:

* no specific exclusion criteria
Efficacy and Physiology of Nasal High Flow Therapy

The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive hypercapnic respiratory failure are still not sufficiently known yet.

The aim of this study is a step-by-step generation of physiological data about gas exchange and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise capacity, quality of life and gas exchange in a long term home treatment compared to a standard low flow long term oxygen therapy (LOT).

Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous carbon dioxide partial pressure (PCO2) after four weeks of treatment.

Stage 1: Respiratory Physiology. Aim of this Stage is to investigate the effects of nasal High Flow (NHF) therapy in patients in progressed stages of COPD, by measuring physiologic parameters like tidal volume, breathing frequency and expiratory PCO2 concentration.

Stage 2: Efficacy of short term NHF. Aim of this Stage is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two PSG sleep studies during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.

Stage 3: Home Care monitoring. Aim of this Stage is to compare long term influences of NHF and LOT on PCO2 levels randomised crossover, 4 weeks each treatment.

Stage 4: Long Term Home Care monitoring . Aim of this stage is the long term follow up (12 month) of patients to examine the compliance of a sufficient NHF therapy. Patients will retain the NHF therapy if they are responders (PCO2 improvement in stage 3 of at least 2 mmHG with NHF versus LOT) and willing and able to use NHF and a patient log.

All patients will be monitored for the next 12 month. After 6 month there will be a control phone call.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-80
* Male and female
* COPD patients with chronic respiratory insufficiency (pH \>7.35 and PCO2 \> 50mmHg)
* Stable respiratory situation

Exclusion Criteria:

* Decompensated heart, liver or kidney failure.
* Pregnancy or nursing period
* Participation in another clinical trial within the last 4 weeks
* Drug abuse
* Incapable of giving consent
* Known obstructive sleep apnea syndrome (OSA) (AHI\>10)
* noninvasive ventilation (NIV) therapy
Prospective Quality of Life Study in Pituitary Surgery

Post-operative assessment and debridement are key components in patient care for surgery patients. However, a standardized protocol for management after endoscopic skull base surgery is unavailable. In this study, investigators will observe the effect of various follow-up schedules on the patient's quality of life after surgery. Patients who received surgery for pituitary adenoma will be placed randomly in 1 of 3 groups (short-term = follow-up in 2 weeks and 8 weeks after surgery; intermediate = 4 weeks and 8 weeks; long-term = 8 weeks). At each visit, patients will be asked to complete a packet of surveys and questionnaires that provide metrics on their quality of life in addition to receiving standard patient care (post-operative assessment and nasal debridement). Researchers hope to find that a follow-up schedule that has patients visiting the clinic closer to their surgery date will increase the patient's quality of life after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Has surgery for pituitary adenoma at UVA after May 1st, 2018
* Has sellar and parasellar pathology
* ≥ 18 years old
* Can complete all parts of study in English

Exclusion Criteria:

* Extended approaches
* Use of naso-septal flap during the current surgical procedure
* Septoplasty
* Prior history of Chronic Rhinosinusitis (CRS)
* Prior history of sphenoidotomy
* \< 18 years old
* Prisoner
Combination of Oral Fludarabine, Mitoxantrone Und Rituximab Induction Therapy and Rituximab Maintenance Therapy in Follicular B-Cell Lymphoma

Immunotherapy with the monoclonal anti-CD20 antibody rituximab has become standard of care for patients with follicular lymphoma. However, there are still open questions regarding dosing and scheduling of rituximab, optimal type of chemotherapeutic combination partners during induction as well as the best interval and length of rituximab maintenance treatment. Fludarabine-mitoxantrone combinations have shown strong debulking activity as initial therapy followed by rituximab maintenance. While rituximab maintenance with a standard dose of 375 mg/m2 prolongs clinical remissions, administration schedules still vary: Three-monthly infusions for 2 years and two-monthly infusions for one or 2 years are most frequently used. A few pharmacokinetic data for rituximab have been reported for induction treatment. These studies have proposed a presumptive "active" level of 25.000 ng/ml in anti-lymphoma treatment. However, there is only limited information regarding maintenance treatment in patients who are in remission and have no remaining tumor load.

The aim of this trial is to investigate the effect of treatment with oral Fludarabine, Mitoxantrone und Rituximab and Rituximab maintenance on the depth of remission measured by BCL2/IgH PCR.


Eligibility Criteria:
Inclusion Criteria:

* a positive BCL2/IgH rearrangement in peripheral blood (PB) and/or bone marrow (BM)
* clinical stage III or IV, requiring treatment with one or more of the following criteria: symptoms related to the disease, hemoglobin less than 12 g/dL, platelets less than 100 G/L, progressive disease, bulky tumor of more than 10 cm

Exclusion Criteria:

* pretreatment
Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis

TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis, minimizing complications, predictors of outcomes and approach preference is still an area of study. Here we decided to study the outcomes of patients undergoing TAVI, different approaches used and their subsequent results and complications.

Severe symptomatic aortic stenosis in elderly patients represents a surgical challenge for cardiac surgeons due to heavy calcifications and associated comorbidities. Such conditions usually are associated with dramatic intra and postoperative complications leading to many cases being declined for open surgical replacement. Many treatment modalities were described including trans-catheter valvotomy but with only temporary improvements and high rates of recurrence.

Transcatheter Aortic Valve Implantation (TAVI) has offered an alternative solution to such cases in which open surgery is deemed too risky or prohibited. Percutaneous Heart Valves (PHV) implantations have been experimented on animals since the early 1990s. Yet the first human case was not reported till 2002, in which a percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed and implanted through the antegrade trans-septal approach in a patient presenting with severe calcific aortic stenosis associated with many noncardiac comorbidities including leg ischaemia. Despite Patient's death after 17 weeks due to noncardiac causes, his follow-up showed significant improvement of left ventricle (LV) function and aortic valve area after implantation of the percutaneous valve.

This case was followed by several single-center and small multicenter registries and series that included inoperable or very-high-risk patients, which were associated with promising results that confirmed the feasibility of TAVI.

Many approaches are used for TAVI with the transfemoral approach being the primary option. Abnormalities of the iliofemoral anatomy have led to the emergence of other approaches including transapical, subclavian, axillary, and transaortic routes. Potential advantages of such approaches would be the avoidance of using large catheters though the iliofemoral system, aortic arch, ascending aorta, and aortic valve. Yet, their main disadvantage would be the need for general anaesthesia.

As any surgical procedure, TAVI carries some risk of complications, major vascular injuries, stroke, conduction abnormalities, myocardial infarction, coronary obstruction and acute kidney injury have been reported. Although, careful planning, patient selection, perioperative workup and individualised approach choice play an important role in avoiding such problems.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe symptomatic aortic stenosis undergoing TAVI.

Exclusion Criteria:

* Patients with concomitant valvular heart disease.
The Effect of Honey on Nocturnal Cough and Sleep Quality

Cough is a common symptom in pediatric practice. It can be particularly troubling to children and their parents.It often results in discomfort to the child and loss of sleep to both the child and the parent. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo

Cough is a common symptom in pediatric practice.As a result, children miss daycare or school and parents miss a day of work. In an attempt to threat cough, caregivers frequently administer OTC medication to their children,with their attendant risks, kack of proven efficacy and the disapproval of professional organizations such as the AAP and the FDA. The WHO has noted honey as a potential treatment for cough and cold symptoms. Honey has antioxidant properties and increases cytokine release. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo

Eligibility Criteria:
Inclusion Criteria:

* 1-5 years of age complying of nocturnal cough that was attributed to a URI.

Exclusion Criteria:

* asthma,
* pneumonia,
* laryngotracheobronchitis,
* sinusitis,
* allergic rhinitis,
* use of cough or cold medication on the night before entering the study.
The Efficacy of Surgical Site Treatment With Ropivacaine in Laparoscopic Surgery

Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs.

At the end of laparoscopic surgery the investigators will spray ropivacaine in the surgical site; and later the investigators will monitor pain intensity and use of analgesic drugs

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic bariatric surgery
* Laparoscopic inguinal hernia surgery

Exclusion Criteria:

* Cardiac arrythmias
* Active ischemic heart disease
* pregnancy
Listening to Mom in the NICU: Neural, Clinical and Language Outcomes

The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.

Children born preterm are at-risk for developmental language delays. Language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. There is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development.

Participants will be randomly assigned to one of two study groups. Each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. Mother's of participating infants will have her voice recorded as she reads a common children's storybook. Recordings will be played to infants each day until s/he is discharged from the hospital. Participation in this study requires that all infants receive up to an additional 10 minutes of brain scans as part of his/her routine clinical magnetic resonance imaging (MRI).

Eligibility Criteria:
Inclusion Criteria:

* Infants born preterm at Stanford Children's Hospital between 27 0/7 - 31 6/7 weeks gestational age

Exclusion Criteria:

* Congenital anomalies
* Recognizable malformation syndromes
* Active seizure disorders
* History of Central Nervous System infections
* Hydrocephalus
* Major sensori-neural hearing loss
* Likelihood to be transferred from NICU to alternate care facility or home environment prior to 36 weeks PMA
* Intraventricular Hemorrhage Grades III-IV
* Cystic periventricular leukomalacia (PVL)
* Surgical treatment for necrotizing enterocolitis
* Small for gestational age (SGA) \<3 percentile and/or Intra-uterine growth restriction (IUGR) no head sparing
* Twin-to-twin transfusions
Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Retrospective Study

This is a nationwide, multicenter and retrospective cohort study. The purpose of this study is to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.

About 9.2%-45.8% of Chinese patients with Non-small cell lung cancer were positive for EGFR gene mutation. Gefitinib, Erlotinib, Icotinib, Afatinib showed efficacy superior to that of chemotherapy in the treatment of EGFR mutation positive advanced NSCLC, and lower rates of serious adverse events. However, after a median of 8 to 13 months of disease control, patients ultimately progress due to acquired resistance of EGFR-TKIs. Elemene, a chemotherapeutic isolated from the Chinese medicinal herb Rhizoma Zedoariae, has been shown to have a comprehensive anti-tumor effect and the potential effect on reversing drug resistance.

The study is a real-world study and the case records of patients with advanced non-small cell lung cancer who visited the research centers from January 2014 to December 2017 and met the inclusion criteria will be collected. Medical data including patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, and so on will be extracted to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed advanced non-small cell lung cancer(stage IIIB\~IV).
2. Patients with EGFR mutation.
3. Received EGFR-TKIs at least once.
4. Received Elemene Injectable Emulsion and/or Elemene Oral Emulsion at least once ( only for Elemene plus TKIs group).
5. Completeness of important outcome measures and medical records related to the study.

Exclusion Criteria:

1. Accompanied by other active tumors.
2. The researchers did not consider it appropriate to participate in this study for other reasons.
ACL Reconstruction With the TLS Technique

This is a non-interventional study to retrospectively validate the technical use TLS (Tape Locking Screw) in the anterior cruciate ligament. The investigators goal is to test the validity of the technique and its positive influence on the resumption of sporting activities in relation to the existing literature.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.

Exclusion Criteria:

* Patients under 18 years
Benefits of Intrahospital Exercise Program in Pediatric HSCT

This randomized control study examines the effect of an intrahospital exercise regimen on the physical deconditioning that occurs due to hematopoietic stem cell transplant in the pediatric population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ages 4-21 years of age who present for hematopoietic stem cell transplant.
2. Karnofsky (if ≥16 years) or Lansky (if \<16 years) score \>60 at enrollment and prior to each testing point
3. Parental/guardian permission (informed consent) and child assent prior to transplant.

Exclusion Criteria:

1. Patients with any preexisting need for gait assistance such as crutches, wheelchair, braces, or walker
2. Previous stem cell transplant in the last 6 months
3. Patients with grade 3 or greater sensory/motor neuropathy
A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)

This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.

The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.

Eligibility Criteria:
Inclusion Criteria:

* Bunion removal

Exclusion Criteria:

* Any known allergies to the study design
Studies of Mothers With Postnatal Depression

This study investigates the effects of a single dose of oxytocin (OT) delivered via a nasal spray in women with and without traits of postnatal depression (PND).

A double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design will be conducted.

Participants will include mothers and their infant in the postnatal period. All participants will be screened for symptoms of low mood on the Edinburgh Postnatal Depression Scale (EPDS) and then assigned into 2 groups comprising probable PND cases and controls.

All participants will take part in 3 conditions at Baseline (before nasal spray administration), Condition 1 (after first OT/Placebo administration) and Condition 2 (after second OT/Placebo administration), and will complete the same order of tasks.

Eligibility Criteria:
Inclusion Criteria:

* All mothers will be aged ≥18 years old.
* Mothers in the clinical group will score above the clinical cut-off point on the EPDS.
* Mothers in the control group will score below the clinical cut-off point on the EPDS.
* Mothers must be able to read and write English at a level sufficient to complete study related assessments.

Exclusion Criteria:

* If the mother is younger than 18 or post-menopausal
* If the pregnancy was a result of fertility treatment
* If the mother is pregnant
* If the mother has history of psychotic illness
* If the mother is at risk of self-harm
* If the mother is involved in other active drug trials