cyrilzakka/clinical-trials huggingface dataset:
Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI

Colon cancer with metastase in the diagnose time account for one significant rate and has a increasing trend. The treatment result of this patient group rests modest. The biological therapeutic treatment is still expensive for major part of Vietnamese patients. So that, research on a new affordable and efficacious chemotherapy combination for these patients is extremely necessary in our country The purpose of the study is to comment somes clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable.

The second aim is to Evaluate the treatment result and toxicity of FOLFOXIRI in these patients

In the world, colorectal cancer is the third most common cancer in male and the second most common cancer in female. In VietNam, the disease is the fourth cancer in male, the sixth cancer in female and increasing recently. About 20-40% of the colon cancer patients had distant metastasis at the time of diagnose, those treatment outcome remains poor (5years survival is about 11%). The targetted therapy medications are still not affordable for majority of Vietnamese patients. So that, 3 cytotoxic drugs (5-Fluoro-Uracil, Oxaliplatin and Irinotecan) remain back-bone in the treatment of metastatic colon cancer.

According to one meta-analysis, the overall survival rate significantly correlated to the use of all 3 these drugs in the treatment time. If patients were give two drugs as the doublet in a line (FOLFOX/XELOX, FOLFIRI/XELIRI), not 100% of patients are treated with all 3 these drugs because some abandonned the following treatment lines. So, the trials that give all 3 drugs in a line (first-line) as triplet (FOLFOXIRI) were carried out and had primirily good outcome. In 2010, FOLFOXIRI were recommended in NCCN guideline.

In VietNam, FOLFOXIRI has been applied to treat patient since 2013. However, since then there was no clinical trial to evaluate the efficacy and the toxicity of this combination. Therefore, we carried out the work "Research on the treatment of metastatic colon cancer patients treated by FOLFOXIRI"

Eligibility Criteria:
Inclusion Criteria:

* 39 colon cancer patients with metastase at the diagnotic time, impossiblity of radical resection, adenocarcinoma, treated by at least 3 cylces of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department, Ha Noi medical university hospital, from September 2013 to April 2017
Effect of HICT and LIIT on Functional Strength and Weight Efficacy in Overweight and Obese Females

This study is aimed at determining the effects of high-intensity circuit training versus low-intensity circuit training on functional strength and weight efficacy in overweight and obese females.

A high-intensity circuit promotes muscle mass and as a result, potentially reduces the incidence of cardiovascular disease and reduces the risk of death in the young population. Low-intensity interval training increases muscle circulation and improving the uptake of oxygen. Both high-intensity circuit training and low-intensity interval training enhance body composition, quality of life, functional fitness and decrease body mass index. These trainings also motivate participants to continue their exercise. This study will help us determine whether high intensity or low-intensity training is more helpful in improving the functional strength and weight efficacy in overweight and obese females. As obesity is on the rise in modern society, our results will help improve the quality of life of obese and overweight females.

Eligibility Criteria:
Inclusion Criteria:

* Females with BMI \>25 kg/m2.
* Females not engaged in routine exercise programs in last 6 months

Exclusion Criteria:

* Females who are using weight loss products.
* Females having uncontrolled diabetes, thyroid disease, arthritis, cardiac diseases, asthma, hypertension, and recent trauma would not be included in the study.
* Females who are pregnant would not be included in the study.
Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital

The aim of this research study is to compare two different fluids (Human Albumin Solution (HAS) and Balanced Crystalloid that are given via a drip to patients with severe infection (sepsis). The investigators plan to see which fluid is better, and to see if they have a role in improving a patient's recovery time, reducing complications and the length of time they stay in hospital. This study plans to find out if there is evidence that one fluid is better overall to determine the need for a subsequent definitive trial.

This trial will be an open label two-arm, multicentre, pragmatic, parallel group randomised trial of adult patients with community acquired sepsis recruited from the Emergency Department and Medical and Surgical Assessment Units across \~10 UK NHS Hospitals. The treatment phase will be the first 6 hours following randomisation. 30-day and 90-day follow up will be conducted using routine data only. The exception to this will be the first 50 patients enrolled in the study, Health Related Quality of Life (HRQoL) will be measured using the EQ-5D-5L at baseline, 7 days and at 180 days. At baseline, the participant or their relative will be asked to recall the quality of life 4 weeks prior to the index hospital admission. Questionnaires will be administered by direct patient completion or, postal or email survey with telephone follow up for non-responders after two mailings two weeks apart.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (18 years or older) who present to UK NHS hospitals with community acquired sepsis meeting all of the 4 criteria:

1. Clinically suspected or proven infection resulting in principal reason for acute illness;
2. NEWS score ≥5 (or NEWS2 if adopted in recruitment site);
3. Hospital presentation within last 12hrs; and
4. Clinician decision has been made that immediate (within 1 hour) intravenous fluid resuscitation is needed.

Exclusion Criteria:

1. \>1 litre of intravenous crystalloid fluid or any intravenous HAS administered prior to eligibility assessment;
2. Requirement for immediate surgery (within one hour of eligibility assessment);
3. Chronic renal replacement therapy;
4. Known allergy/adverse reaction to HAS;
5. Balanced crystalloid or HAS not available;
6. Known adverse reaction to blood products;
7. Palliation/end of life care (explicit decision by patient/family/carers in conjunction with clinical team that any active treatment beyond symptomatic relief is not appropriate);
8. Religious beliefs precluding HAS administration;
9. Previous recruitment in the trial;
10. Known recent severe traumatic brain injury (within 3 months);
11. Patients with permanent incapacity;
12. Known recruitment in another CTIMP studies within the last 30 days where co-enrolment has not been agreed.
A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants

The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Body weight less than 100.00 kg inclusive at Screening and Check-In Day.
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.

Exclusion Criteria:

* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1

This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 1.1
* Patient who has not had any major protocol violation in Study CT-P13 1.1

Exclusion Criteria:

* Patient who has been withdrawn from Study CT-P13 1.1 for any reason
* Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events(SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the option of the investigator
* Patient who plans to participate in a study with an investigational drug during the period of this extension study
A Retrospective Validation Study To Identify Chart-Based Clinical Diagnosis Of Wild-Type Transthyretin Amyloid Cardiomyopathy (Attrwt-CM) And Non-Amyloid Heart Failure Among Patients With Heart Failure (HF).

This is an observational, retrospective non-inferiority study with a study sample from a large national database.

A machine learning (ML) model will use a national database to predict the clinical diagnosis of ATTRwt-CM among HF patients. This study will include HF patients ≥50 years old.


Eligibility Criteria:
Inclusion Criteria:

* HF patients (defined as having ≥1 claim for HF or HF treatment) ≥50 years old with clinical diagnosis of ATTRwt-CM or non-amyloid HF ascertained by charts. Patients will be required to have ≥12 months of continuous activity in the EHR or claims prior to the Index Date.

Exclusion Criteria:

* Patients with any of the following diagnoses:

  * Light chain (AL) amyloidosis
  * Intracranial hemorrhage
  * Cerebral amyloid angiopathy
  * End stage renal disease
  * Blood cancer
POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis

Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their childbearing years. It is an autoimmune disease of the central nervous system (CNS), which results in a chronic focal inflammatory response with subsequent demyelination and axonal loss. Recent prospective studies reported a significant decline by two-thirds in the rate of relapses during the third trimester of pregnancy and a significant increase by two-thirds during the first three months post-partum by comparison to the relapse rate observed during the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the relapse rate occur at a time when the impregnation of many substances (among which, sexual steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels, immediately following delivery.

It may be hypothesized that sexual steroids could exert beneficial effects through a modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They may also play a direct role in the remyelination of central nervous system lesions, as they do in the peripheral nervous system. The POPART'MUS study is a European, multicentre, randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS relapses related to the post-partum condition, by administering high doses of progestin (nomegestrol acetate), in combination with endometrial protective doses of estradiol. Treatment will be given immediately after delivery and continuously during the first three months post-partum. Assuming the results of the trial to be positive, this new treatment could be considered in the relapsing-remitting phase of the disease in women afar from pregnancy and post-partum.


Eligibility Criteria:
Inclusion Criteria:

* MS according to MacDonald criteria (including clinically isolated syndromes fulfilling magnetic resonance imaging \[MRI\] criteria for MS diagnosis)
* Relapsing-remitting or secondary progressive MS
* Expanded disability status scale (EDSS) ≤ 6.0
* Pregnancy ≤ 36 weeks of amenorrhea

Exclusion Criteria:

* Age \< 18 years
* Clinical isolated syndrome not fulfilling MacDonald criteria for MS
* Primary progressive MS
* Possible MS or no MS according to MacDonald criteria
* Ongoing or previous myocardial infarction, stroke or venous thromboembolism
* Ongoing or previous breast cancer, or cancer of the uterus
* Severe liver disorder
* Undiagnosed genital bleeding
* Hypersensitivity to one of the study treatments
* Desire for lactation
* Desire for an MS disease-modifying treatment in the 24 weeks after delivery
* Women participating in another trial with a drug
* Refusal of non-hormonal contraception in the 12 weeks following delivery
* Consent form not signed
NSAA NON-Interventional Study Protocol

The purpose of this non-interventional study is to evaluate the feasibility of remotely administering the North Star Ambulatory Assessment (NSAA) to participants with Duchenne muscular dystrophy (DMD). The iTakeControl (iTC) software platform will be utilized to remotely administer and score the NSAAs.


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of a signed and dated informed consent document indicating that the participant's legally authorized representative (LAR) has been informed of all pertinent aspects of the study, along with evidence of age-appropriate child assent.
2. Confirmed diagnosis of DMD
3. Participant with DMD aged 4 to12 (inclusive) at t Enrollment date
4. Participant with DMD is ambulatory without assistive devices, braces, or aids throughout the study
5. Caregiver has access to and/or willingness to learn use of a smart phone and the iTC study mobile application
6. Participant and caregiver are based in the US throughout study
7. Participant and caregiver are fluent in the English language (verbally and in writing)

Exclusion Criteria:

1. Non-ambulatory DMD participant at any study timepoint
2. Caregiver/participant unwilling or unable to administer/perform the NSAA
3. Anticipated deterioration of participant's ambulatory status during the study
MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO

The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

Medial Patellofemoral Ligament (MPFL) injury occurs in more than 95% of lateral patellar dislocations. Most of these injuries result in subsequent lateral patellar instability. Therefore, MPFL reconstruction (MPFLR) is often necessary. The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.

Eligibility Criteria:
Inclusion Criteria:

* Lateral patellar dislocation with subsequent instability
* Failure of non-operative treatment

Exclusion Criteria:

* Active inflammation of the knee;
* Previous surgeries on the patellofemoral joint;
* Fractures around the knee
Short-term Fat Overfeeding on the Effects of Liver Metabolism

Despite work showing the overconsumption of saturated fatty acids (SFA) to be metabolically deleterious, debate continues about whether there is a link between SFA and cardiovascular disease risk. To explore this, we are undertaking a human in vivo parallel-design study, comparing two isocaloric high-fat diets; one enriched with SFA and the other enriched with unsaturated fatty acids (UFAs), to determine the impact of dietary fat composition on postprandial metabolism, liver fat, cardiac fat and cardiac function.

The investigators will recruit men and women with no medical condition or relevant drug therapy that affects lipid, glucose or liver metabolism.

Purpose and design:

The investigators are asking the research question: "How does the amount and type of fat consumed, influence liver fat content, cardiac function and postprandial fatty acid and liver fat metabolism when someone is not gaining or losing body weight?"

To address this research question investigators want to undertake detail physiological studies, in a parallel dietary intervention, where individuals will have an MRI/S scans to assess liver fat, cardiac fat and cardiac function, along with a postprandial study day to assess how their metabolic response to a experimental test meal, before and then 28 days after consumption of a eucaloric, high fat intervention diet that will be either enriched in saturated or unsaturated fat.

Eligibility Criteria:
Inclusion Criteria:

* The participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged ≥18 or ≤65 years.
* Body Mass Index ≥19 ≤35 kg/m2
* No medical condition or relevant drug therapy that is known to affect liver or adipose tissue metabolism.
* Weight stable for the previous 3 months

Exclusion Criteria:

* The participant is unwilling or unable to give informed consent for participation in the study. - Aged ≤18 or ≥65 years
* Body Mass Index ≤19 or ≥35kg/m2
* Blood haemoglobin \<135mg/dL for men and \<120mg/dL for women
* Donated (or lost) ≥250 ml of blood in the previous two months.
* On a weight loss diet or have decreased their body weight by \>5% in the previous 3 months.
* Have increased their body weight by \>5% in the previous 3 months.
* Any metabolic condition or relevant drug therapy
* Current smoker
* History of alcoholism or a greater than recommended alcohol intake (\>30 g of alcohol daily for men and \>20 g of alcohol daily for women)
* Haemorrhagic disorders
* Anticoagulant treatment
* History of albumin allergy
* Pregnant or nursing mothers
* Women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months History of severe claustrophobia
* Presence of metallic implants, pacemakers, or are unwilling to remove any piercings
* History of an eating disorder or any other psychological condition that may affect the participant's ability to adhere to study intervention/experimental diets.
Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time.

IVH occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal subarachnoid hemorrhage cases. Evidence supports a strong contribution of IVH to morbidity and mortality after cerebral hemorrhage. External ventricular drainage (EVD) is required clinical management; however, EVD via intraventricular catheter alone fails to prevent much of the morbidity and mortality of IVH. This study seeks to demonstrate the safety and efficacy of intraventricular thrombolysis, using rt-PA, as a method of removing this blood and altering morbidity and mortality. Patients will receive intraventricular injections of rt-PA or placebo every 12 hours. They will be followed prospectively with daily head CT scans during the acute-treatment phase and again between Days 28 and 32.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Inclusion criteria:

* Intraventricular hemorrhage (IVH) confirmed by CT scan
* More than 12 hours post bleed
* Hematoma size stable by CT scan
* Post-IVH catheter CT scan
* Able to begin study within 24 hours of bleed

Exclusion criteria:

* Infratentorial bleed
* Supratentorial bleed greater than 30 cc
* Unclipped aneurysm suspected
* Arteriovenous malformation suspected
* Any severe, complicating illness (e.g., AIDS or DNR)
* Cardiovascular parameters that could confound study (e.g., myocardial infarction, pulmonary emboli, systemic fibrinolysis)
* Active internal bleeding
* Requirement for heparin doses greater than 10,000 U/day
* Concurrent coumadin
* Known allergy to rt-PA
* Pregnancy
Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study

The purpose of the study is to determine whether addition of electroconvulsive therapy to antipsychotic treatment improves the mental health of patients with treatment-resistant schizophrenia.

The purpose of the study is not achieved.

Eligibility Criteria:
Inclusion Criteria:

* An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9
* PANSS total score \>= 70
* CGI-S \>= 4 (Clinical Global Impression)
* PANSS score \>= 4 on minimum 2 og the following items: Delusions, Conceptual disorganization,Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness, Hostility, Disorientation.
* Previous/current treated with clozapine or refused clozapine treatment
* Lack of response to at least three different antipsychotics
* New antipsychotic medication prescribed more than 8 weeks before inclusion
* Fixed dosage of antipsychotics 1 month before inclusion
* No chance of additional neurotropic 4 weeks before inclusion
* Signed informed consent and power of attorney

Exclusion Criteria:

* Significant substance abuse
* Somatic disease that increases the risk of complications of ECT/anesthesia
* Epilepsy
* For women: Pregnancy or breast-feeding
* Homelessness
* Use of benzodiazepines (apart from tbl. oxazepam 10 mg., max 30 mg. daily)
* Use of antiepileptic
* Previous no effect on psychotic symptoms after ECT treatment (minimum 15 ECT- treatments)
* Concrete suicidal plans
Computerized Anxiety Treatment for Suicide

The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.

CATS is a newly developed computerized treatment targeting specific risk factors associated with anxiety symptoms and suicidal thoughts. Individuals will be asked to complete four appointments, where they will complete various self-report questionnaires as well as a newly developed computerized treatment targeting risk factors associated with anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria for a primary Axis 1 anxiety disorder or meet diagnostic criteria for a unipolar mood disorder along with an Axis 1 anxiety disorder.
* Show evidence of current suicidal ideation (BSS above 6.
* Show elevated AS indicated by scoring at or above the community sample mean on the ASI-Cog (above 9.

Exclusion Criteria:

* No significant medical illness (e.g. sig cardiovascular disease, epilepsy, stroke).
* Current or past psychotic-spectrum disorders or uncontrolled bipolar disorder
* No current substance dependence
* Must be an English speaker.
* Must be 18 years or older.
* Must have normal or corrected vision
* Cannot begin treatment/therapy within 1 month of baseline.
* Cannot begin a new medication within 3 months of baseline.