cyrilzakka/clinical-trials huggingface dataset:
PT003 MDI Dose Confirmation Study

The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Key Inclusion Criteria:

* Signed written informed consent
* 40 - 80 years of age
* Clinical history of COPD with airflow limitation that is not fully reversible
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
* A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
* Able to change COPD treatment as required by protocol

Key Exclusion Criteria:

* Women who are pregnant or lactating
* Primary diagnosis of asthma
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Active pulmonary diseases
* Prior lung volume reduction surgery
* Abnormal chest X-ray (or CT scan) not due to the presence of COPD
* Hospitalized due to poorly controlled COPD within 3 months of Screening
* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
* Cancer that has not been in complete remission for at least 5 years
* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other inclusion/exclusion criteria as defined in the protocol
Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia

There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs.

There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia.

The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Full-term children, gestational age\> 36 weeks of amenorrhea
* Between the 1st of January 2012 and the 31st of December 2016
* Hospitalized in the neonatal resuscitation department of Croix Rousse in Lyon
* Perinatal asphyxia with clinical signs of encephalopathy
* Indication of therapeutic hypothermia not retained because EAI mild
* Where parents were informed and did not object to participation in the study

Exclusion Criteria:

* Dysmorphic syndrome
* Stroke
* Children transferred for other criteria (respiratory distress, heart failure ...)
Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT

The main aim of this study is to test the efficacy of a Compassive Acceptance Intervention protocol (developed by the research team) for Chronic Insomnia in comparison with the standard treatment (CBT-I).


Eligibility Criteria:
Inclusion Criteria:

* Insomnia Diagnosis (ICSD-3; DSM-5)

Exclusion Criteria:

* Comorbidity with severe psychiatric/psychological disorder (e.g. severe depression; psychotic disorder)
* Comorbidity with other untreated sleep disorder
* Altered Sleep patterns due to factors different from insomnia (e.g. shift-work; pregnancy)
Decision Aids Upper and Lower Extremity

This study aims to assess differences in choice of treatment (and the rationale behind it), physical function, pain intensity, satisfaction, and decision regret between orthopedic patients who review a decision aid during their visit and those that do not. Decision aids for 23 different conditions are included.

Patients visiting an orthopeadic surgeon in one of our 4 affiliated offices in a large urban area in the United States are invited to participate over a 4 month period. All English-speaking patients, between 18 and 89 years old, visiting an orthopeadic surgeon with a new problem, for which either invasive or non-invasive treatment is possible and a DA is available are asked to participate in this study. Exclusion criteria are non-English speakers or a clear preference for a treatment option by surgeon or patient. Patients will be randomly assigned to either the intervention or the control group in a 1:1 ratio using an Excel random number generator. Patients in the intervention group go over the DA during the visit, once the surgeon has identified the diagnosis. After the diagnosis is set, the surgeon steps out of the visit and steps back in when the patients has reviewed the DA. The surgeon and the patient go over the treatment options and a decision will be made. After the visit, all patients, both in the intervention and control group, are asked to fill out a survey. Two weeks after enrollment a research assistant calls all patients for a follow up questionnaire.

Eligibility Criteria:
Inclusion Criteria:

English-speaking, adult patients seeing an upper or lower extremity surgeon for a new visit regarding diagnoses that can be treated invasively and non-invasively:

Shoulder

* Clavicle fracture in the middle
* Clavicle fracture close to the shoulder
* Proximal humerus fracture
* Humerus shaft fracture
* Distal humerus fracture

Elbow

* Lateral epicondylitis
* Ruptured biceps at the elbow
* Olecranon fracture
* Radial head fracture
* Olecranon bursitis

Hand/wrist

* Distal radius fracture
* Carpal tunnel syndrome
* Scaphoid fracture
* Thumb arthrosis
* Trigger finger
* Mallet fracture
* de Quervain tendinopathy
* Wrist ganglion
* Dupuytren

Knee • Knee arthritis: cortisone injection

Hip

• Hip arthritis: total hip arthroplasty

Exclusion Criteria:

* Obvious indication for one treatment approach, either from the surgeon or the patient perspective.
* Patients who do not want to be contacted for follow-up.
* Non-English speaking patients, because the decision aids used in this study are not currently validated to non-English language.
the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer

The purpose of this study was to observe the relationship between ctDNA as a molecular marker of colorectal cancer and the risk of postoperative recurrence.

In this clinical study, ctDNA will be detected in postoperative patients with stage Ⅱ and Ⅲ colorectal cancer to evaluate the correlation between ctDNA and the risk of postoperative recurrence. According to the dynamic changes of ctDNA after adjuvant chemotherapy, the correlation between ctDNA and postoperative DFS will be compared, and the feasibility of ctDNA as a molecular marker to evaluate the risk of postoperative recurrence of colorectal cancer will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with colorectal cancer diagnosed pathologically as stage Ⅱ and stage Ⅲ.
* 2. The patient underwent radical surgical treatment.
* 3. The patient has the results of genetic genetic testing for gastrointestinal tumors, including the genetic mutation status of MMR genes and related genes (MLH1, MSH2, MSH6, PMS2, MLH3, EPCAM).
* 4. The patient understands and is willing to sign a written informed consent document.
* 5. During the treatment process, the patient can cooperate to provide samples of each node.
* 6. The patient can provide corresponding clinical materials, including but not limited to case diagnosis, imaging evaluation, and serum protein marker test results.

Exclusion Criteria:

* 1. The patient cannot provide a complete and qualified specimen.
* 2. The patient has other primary malignant tumors or serious medical illnesses.
* 3. The patient cannot cooperate with the follow-up.
* 4. Conditions that other researchers deemed inappropriate for continuing to participate in the study.
Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

The Competence Centre for Transcultural Psychiatry is a clinic specialised in the treatment of traumatised refugees. There is a lack of studies on treatment effect in traumatised refugees. There are several studies indicating an effect of cognitive behavioural therapy (CBT) in Posttraumatic Stress Disorder (PTSD). A few studies point to that CBT could be effective in traumatised refugees. There are no studies examining if some methods used in CBT are more useful than others in traumatised refugees. The aim of this study is to examine the effect of CBT with focus on Stress Management versus cognitive restructuring. Patients included in this study will be randomised to either Stress Management or cognitive restructuring. All referred patients will receive medical treatment as usual (described in the clinic's manual for medical doctors, 2011). All patients that fulfill the inclusion criteria will be included in the study. Hopefully this study will contribute to improve the psychotherapeutic treatment offered to traumatised refugees.


Eligibility Criteria:
Inclusion Criteria:

* Refugee or patient that has been reunified with family member being a refugee.
* Symptoms of PTSD in accordance with International Classification of Diseases-10 (ICD-10) research criteria.
* Trauma in the past such as imprisonment, torture (according to UN definition), war experiences.
* Referred by a medical doctor.
* Motivated for treatment.
* Informed consent.

Exclusion Criteria:

* Severe psychotic illness such as schizophrenia or bipolar disorder
* Drug abuse
* Patients admitted to in ward treatment
* No informed consent
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock

The goal of this clinical trial is to investigate whether methylene blue injection can safely and effectively improve the survival rate of patients with severe septic shock, shorten the duration of norepinephrine use, reduce the dosage of vasopressors, promptly correct hemodynamics, and improve tissue perfusion and organ function impairment.

Researchers will compare methylene blue to a placebo (a look-alike substance that contains no drug) to see if methylene blue works to treat severe septic shock.

Participants will:

Administer a loading dose of 2.5 mg/kg via micro-pump over 15 minutes, followed by a maintenance infusion at a rate of 0.25 mg/kg/hour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours, whichever comes first. If norepinephrine needs to be increased to 0.25 μg/kg/min before the 12-hour period ends, continue using methylene blue until the 12-hour infusion is completed.

Primary Study Endpoint

- 28-day all-cause mortality rate starting from the diagnosis of septic shock.

Secondary Study Endpoints

* Time from the start to the discontinuation of norepinephrine after the diagnosis of septic shock.
* Total dose of norepinephrine used (from enrollment to 72 hours).
* Number of days without norepinephrine within 28 days.
* Duration of mechanical ventilation.
* Rate of CRRT (Continuous Renal Replacement Therapy).
* Length of ICU stay.
* Total hospital stay.

Record the following indicators before methylene blue intervention and at 24 hours, 72 hours, and 5 days after the intervention:

* Highest serum lactate level.
* Lowest mean arterial pressure.
* Alanine aminotransferase (ALT).
* Total bilirubin.
* Creatinine.
* Oxygenation index (P/F ratio).
* Creatine kinase-MB (CK-MB).
* Troponin I (TNI).
* Systemic vascular resistance index (SVRI).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Meets the Sepsis 3.0 criteria for septic shock: patients with infection who, despite adequate fluid resuscitation, require vasopressor therapy to maintain a mean arterial pressure (MAP) of ≥ 65 mmHg and have a blood lactate concentration \> 2 mmol/L.
3. Diagnosed with septic shock and started on norepinephrine within 24 hours.
4. Requires a norepinephrine dose of ≥ 0.1 μg/kg/min to maintain a MAP of ≥ 65 mmHg.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Individuals allergic to methylene blue or any components of the methylene blue injection.
3. Individuals with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
4. Patients with an expected survival time of less than 48 hours.
5. Patients who have been on norepinephrine for more than 24 hours.
Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer

In this study, clinical impacts of shared decision making between physicians and patients in strategy of surveillance for asymptomatic patients who ended the primary treatments on quality of life would be investigated

\[Background\]

1. Shared decision making between patients and physicians when breast cancer patients encounter decision making in the initial treatment process has already been included in the recommendations for breast cancer treatment in each country. However, in the follow-up stage using various imaging tests after the initial breast cancer treatment, the evidence of decision making is very poor and the patient who understands this well and actively participates in the process of deciding the follow-up strategy are almost none.
2. Major guidelines including NCCN, ASCO and ESMO recommend surveillance with routine imaging such as sonography and mammography, and does not recommend advanced imaging tests for asymptomatic patients. These guidelines are based on two prospective randomized trials conducted in 1994. Despite many international medical recommendations, many institutions around the world are increasingly using distant metastasis tests in belief of improving the survival rate through early detection of distant metastasis and of improving the emotional stability of doctors and patients.
3. In this study, clinical impacts of shared decision making in strategy of surveillance for asymptomatic patients on quality of life would be investigated by prospective randomized pragmatic trial. Additionally, oncological results would be analyzed and real world data of patients preference would be gathered

\[Study design\] Prospective, single-institutional, randomized pragmatic trial

\[Statistical considerations\] With 5% significance level and 90% power, 132 patients are needed in each group. Assuming a 28% drop out rate, 368 patients need to be recruited.

\[Randomizations\] Web-based randomization would be conducted stratified to subtypes.

\[Objectives\]

1. Primary objective

   - QoL (when enrollment, after 1 and 2 year - FACT-B score)
2. Secondary objectives

   * Depression - anxiety scale (HADS score)
   * Recurrence-free survival
   * Patients' preference for surveillance in SDM group
   * Cross over rate in SDM group

Eligibility Criteria:
Inclusion Criteria:

* Women between 20-70 years
* Invasive unilateral breast carcinoma with histological confirmation
* History of invasive breast cancer
* TMN stage I-II according to AJCC 7th
* Histologically or radiologically no suspicion of distant metastases
* Performance status corresponding to ECOG grade 0-2
* No psychological and geographical restriction in follow-up
* Written informed consent

Exclusion Criteria:

* History of any cancer in the previous 5 years
* Bilateral breast cancer
* Male breast cancer
* Patients who are planning for surveillance in other institutions
* Unable to understand and fill out questionnaires
Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia

Arthroscopic rotator cuff repair is a commonly performed procedure but is known to cause significant postoperative pain. Effective analgesia after rotator cuff repair is crucial in improving the well-being of the patient but also to ensure long-term rehabilitation. The most commonly used analgesic for acute postoperative pain is opioids. However, the use of opioids is accompanied by several side effects which include but are not limited to nausea/vomiting, urinary retention, itching sensation and sometimes dizziness, respiratory depression and hypotension in higher doses. As of late, many efforts are aimed toward decreasing the use of opioids by using multimodal analgesia. Among such methods, intravenous lidocaine has been reported to be effective, safe and economic in various procedures. However, the existing evidence is mostly focused on laparoscopic procedures. The present study aims to find whether perioperative infusion of lidocaine is able to decrease opioid requirements after surgery and also improve postoperative pain compared to placebo in patients undergoing arthroscopic rotator cuff repair.


Eligibility Criteria:
Inclusion Criteria:

1. ASA class 1-3 adults over 19 years scheduled for elective arthroscopic rotator cuff repair

Exclusion Criteria:

1. Known allergies to lidocaine or propofol
2. Cardia arrhythmia
3. History of epilepsy or seizures
4. Liver/kidney failure
5. History of recent strong opioid use
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons

The effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17 spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs. The LTS improved significantly the functional scoliotic spinal alignment in the frontal and sagittal planes regardless of the severity of scoliosis.

SCI patients often develop progressive scoliosis due to loss of muscular support to maintain good sitting posture. Special seating with LTS has been widely used in clinical practice to improve their sitting postures. However, little is known as to how this can affect the scoliotic curve.The purpose of this study was to investigate the effects of lateral trunk supports (LTS) in special seating on the spinal alignment of spinal cord injured (SCI) individuals with scoliosis.

Ten male and seven female SCI subjects with scoliosis sat on an experimental chair with and without LTS while radiographs of the spine in the anteroposterior and lateral directions were taken. Radiographs of the spine in the A-P and lateral directions were taken with a digital radiographic imaging system (Saturn 9000 M, Comed., Korea). For each direction, the complete image of the spine was obtained from separate x-ray images of the upper and lower trunk due to the limited field of view of the x-ray machine. The Cobb angles and scoliotic indices based on the anteroposterior radiographic images and the angles of the thoracic and lumber spine based on lateral were calculated.

Eligibility Criteria:
Inclusion Criteria:

* (1) C4-T12 SCI, (2) onset over 1 year, (3) sitting on the wheelchair more than 4 hours per day, (4) diagnosed thoracic or lumbar scoliosis through A-P radiographs, (5) flexible scoliosis, confirmed by supine and side-lying bending radiographs.

Exclusion Criteria:

* inflexible scoliosis
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in ME/CFS

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by patient
2. Male or female patients age 18 and older.
3. Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) based on the proposed diagnostic criteria of the National Academy of Medicine

Exclusion Criteria:

1. Refusal by patient to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud
INSIGHT - Post Marketing Surveillance

In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.


Eligibility Criteria:
Inclusion Criteria:

* In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information
Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality

The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF) distributions have a greater impact on children's health than the standard RUSF distributions during the hunger gap period (june to september). We estimated that the 12 month RUSF will decrease the incidence of severe acute malnutrition by 33% compared to an administration only during the hunger gap period (4 month a year).


Eligibility Criteria:
Inclusion Criteria:

* children between 6 months and 24 months of age

Exclusion Criteria:

* children who can 't swallow
* children from parents who does not want to be in the study
Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease

Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.

After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

The clinical trial will include a control group (waiting list).

Patients who meet eligibility requirements will be assigned to control group or intervention group.

Psychological intervention will consist in an 8-session individual face-to-face delivered ACT-based treatment.

The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease on haemodialysis
* Older than 18 years-old
* At least 3 months on haemodialysis
* HADS Global Scale Score ≥14

Exclusion Criteria:

* Diagnosis of severe or chronic mental disorder, mental retardation and cognitive impairment, or disabling illness.
* Antidepressant drugs consume
* Insufficient understanding of Spanish.
* Patients who are in the Advanced Chronic Kidney Disease Unit
* Receiving other psychological treatment