cyrilzakka/clinical-trials huggingface dataset:
Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.

In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults over 18 years old
* At least one adenocarcinoma of colon and/or rectum, histologically proven.
* No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion)
* At least one hepatic metastasis which R0 resection is possible through a conventional simple resection
* Informed written consent.

Non inclusion criteria:

* Heart, Respiratory or Renal failure
* Physical or psychological dependence
* Chronic liver disease
* Extra-hepatic metastases

Exclusion Criteria (at time of surgery)

* Localized or diffuse peritoneal carcinomatosis
* Non resectable lymph node metastases
* Colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately
* Other hepatic lesions diagnosed with ultrasound making liver R0 resection impossible immediately
Efficacy of Premixed Nitrous Oxide and Oxygen in Patient With Out-of-hospital Moderate Acute Pain

Less than 10% of patients with a traumatic pain have been managed by a physician before to be admitted in an emergency service. 50 % of those patients have been carried by paramedics. Premixed nitrous oxide and oxygen is often used by paramedics, but no scientific studies have demonstrated its efficacy. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen in patients with out-of-hospital moderate acute pain.

The study will evaluate the efficacy of premixed nitrous oxide and oxygen (MEOPA) in patients with out-of-hospital moderate acute pain.

The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower) 15 minutes after randomisation. Secondary endpoints are treatment safety and adverse events, time to analgesia and duration of analgesia. This study will expect 60 patients assigned in two parallel groups, defined by a randomization scheme. Group assignments were sealed in opaque envelopes and will be open sequentially by the dispatcher when the paramedic is ready to include the patient. The letter contained in the envelope corresponds to the cylinder to use. Eligible patients with a numeric rating scale (NRS) score between 3 and 6/10 are randomly allocated to receive either MEOPA, or medical air. Fifteen minutes after the randomisation, all patients will receive MEOPA from a distinct cylinder. Pain score will be measured at baseline and every 5 minutes until pain relief will be obtained. The paramedic blinded to the analgesic treatment groups will do all assessments of patients. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, oxygen saturation by pulse oximetry (SpO2) and adverse events collection.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years old
* Patients with a moderate acute pain (NRS score between 3 and 6)

Exclusion Criteria:

* Contraindication of premixed 50% nitrous oxide and oxygen
* Recent treatment of analgesic (less than 6 hours)
Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule

Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history.

aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule to treat type II diabetes mellitus.

---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes

Preliminary evaluation on the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes, and provides basis for determining optimal dosage of Tangning Tongluo capsule.

Eligibility Criteria:
Inclusion Criteria:

1. Fulfilled diagnostic criteria for type II diabetes and TCM syndrome diagnostic criteria.
2. Age between 18-70 years.
3. The blood sugar meet the following criteria: fasting blood glucose ≥ 7.0mmol/L, ≤ 13 mmol/L and (or) ≥ 2 hour postprandial blood glucose 11.1 mmol/L, ≤ 16 mmol/L; eligible conditions in blood glucose, glycosylated hemoglobin to ≤ 10%.
4. Traditional Chinese medicine symptom score ≥ 4 points.
5. Participated in the experiment voluntarily, and signed the informed consent form.

Exclusion Criteria:

1. Durring the cleaning period, blood sugar dropped to below detection diagnosis value through diet, increasing activity.
2. Secondary diabetes mellitus or nearly a month using insulin; or is the use of insulin sensitizers (thiazolidine two ketones), repaglinide, Bernard Glenn Nai, alpha glucoside enzyme inhibitor (acarbose, voglibose), other traditional Chinese medicine.
3. Within the past 1 months, with diabetic ketoacidosis and other acute metabolic disorders.
4. ALT is 2 times higher than the upper limit of the normal value, Cr is higher than the upper limit of normal persons.
5. Has severe heart, liver, renal, hematopoietic system disease, or other serious diseases and mental disease patients.
6. Pregnant, lactating women and prepare for pregnancy.
7. The allergic constitution and the drug allergy known composition.
8. For nearly a month with severe infection or other emergency state, such as trauma, operation etc..
9. within the past 3 months, participated in the other drugs.
RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)


Eligibility Criteria:
Inclusion criteria

Inclusion criteria (selected):

* Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement
* Written Informed Consent

Exclusion criteria

Exclusion criteria (selected):

* Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
* Active malignant disease or current cytostatic treatment
* Known severe renal insufficiency
* Liver disease expected to have any potential impact on survival, or elevated aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 2x upper limit of normal
* Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
* Pre-menopausal women who are pregnant or nursing, or are of child-bearing pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control
* Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced thrombocytopenia) or dabigatran
* Contraindications to enoxaparin
* Participation in a clinical trial during the last 30 days
Metabolic Effects of High-amylose Wheat-based Rusks.

Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese;
* 30-60 years.

Exclusion Criteria:

* age \<30 and \>60 years;
* fasting triglycerides ≥400 mg/dl;
* fasting cholesterol \>270 mg/dl;
* cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study;
* established diabetes mellitus or any chronic disease;
* renal and liver failure (creatinine \>1.7 mg/dl and transaminases \>2 times than normal values, respectively);
* anaemia (Hb \<12 g /dl);
* any chronic disease.
Red Blood Cell Transfusion in the Ambulatory Setting: Impact on Home Functional Status

Do ambulatory RBC transfusions improve home functional status?

Background: Red blood cell (RBC) transfusion is frequently employed in both ambulatory and hospital environments with the aim of improving patient functional status. The efficacy of this 10.5 billion dollar per year practice however has been increasingly called into question. The Investigators propose to directly measure the impact of outpatient RBC transfusions on at-home functional status by recording several physiological parameters and quantifiable physical activity metrics, e.g. daily energy expenditure and daily total step count, using the ActiGraph wGT3X-BT. This device is an accelerometer-based wearable similar in size to a small watch and is worn at the waist. Study participants will wear the device during the course of their daily activities giving the investigators quantifiable insight into activity levels in the home environment.

Methods/Design: This will be a randomized crossover pilot clinical trial with participant study duration of 28 days. The crossover nature allows each patient to serve as his/her own control. Details of the study design are provided in the text. Briefly, patients presenting at Mayo Clinic Scottsdale's Ambulatory Infusion Center (AIC) will be randomized to one of two arms: 1) receive an RBC transfusion as scheduled (transfuse), or 2) abstain from the scheduled transfusion (no-transfuse). After an appropriate washout period, patients will cross from the transfuse arm to the no-transfuse arm or vice-versa. Activity levels will be recorded continuously throughout the study with no need for intervention by the patient. In addition to device data, survey data will be collected via a weekly telephone interview. The primary outcome measures will include both technical performance metrics such as daily energy expenditure as well as practical performance metrics such as changes in step count. A variety of secondary outcome measures include daily sedentary time and PROMIS Global 10 scores.

Discussion: This trial will directly assess the impact of red blood cell transfusion on patient functional status in the location most important - the home. Patient recruitment will begin in August 2016 and is due to be completed in August 2017.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* At least on prior encounter in the AIC
* Planned RBC transfusion

Exclusion Criteria:

* Refusal to provide informed consent
* Refusal by the health care team
* Acute ischemia (e.g. MI, CVA)
* Hemoglobin \< 7.0 g/dL
* Active bleeding
* Symptomatic anemia (hypotension, tachycardia, angina, syncope/pre-syncope believed related to anemia
* Non-ambulatory functional status
* Established or Uncertain Pregnancy Status
ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

The overall aims of the study are:

* To assess the bioavailability of single doses of ALX-0061, administered s.c. at three dose levels, using 2 corresponding single i.v. dose levels as reference.
* To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061.
* To further determine the safety and tolerability of ALX-0061.
* To further evaluate the systemic (serum) immunogenicity of ALX-0061.


Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy volunteers.
2. Gender: male or female.
3. Age 18 to 55 years.
4. Body mass index (BMI): 18.0 ≥ BMI \< 30.0 kg/m2.

Key Exclusion Criteria:

1. Any active inflammatory condition, or autoimmune disorder such as lupus erythematosus, multiple sclerosis or rheumatoid arthritis (RA).
2. Any current or recent (within 4 weeks prior to dose) signs or symptoms of infection that requires parenteral antibiotic administration.
3. Symptomatic infection, or suspicion thereof in the last 1 week prior to dosing.
A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)


Eligibility Criteria:
Inclusion Criteria:

* Manifest HD diagnosis, defined as a DCL score of 4
* Independence Scale (IS) score \>= 70
* Genetically confirmed disease by direct DNA testing with a CAP score \>400
* Clinical assessment to ensure individual has intact functional independence at baseline to maintain self-care and core activities of daily living (ADLs).

Exclusion Criteria:

* Any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia at screening that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug
Dexmedetomidine Versus Midazolam for Peribulbar Block

50 patients of both sexes, ages 18 to 75, who were scheduled for cataract surgery and had physical status I or II according to the American Society of Anesthesiologists were included in this study.

After induction of general anesthesia, all patients received peribulbar block. In group A (midazolam group), 25 patients received midazolam. In group B (dexmedetomidine group), 25 patients received dexmedetomidine.

Background: Peribulbar blocks are commonly used for cataract surgery, providing effective anesthesia with reduced recovery time. The addition of sedative agents, such as dexmedetomidine or midazolam, may enhance the anesthetic effect and patient comfort while maintaining hemodynamic stability. However, the optimal sedative agent for use in this context remains uncertain.

Objective: This study aimed to compare the efficacy and safety of dexmedetomidine and midazolam as adjuvants to local anesthetic in peribulbar blocks for cataract surgery.

Methods: A randomized, double-blind clinical trial included 50 patients aged 18-75 years with the American Society of Anesthesiologists physical status I-II who were scheduled for cataract surgery under peribulbar block. Participants were randomly allocated to two groups: Group A received midazolam (1 mg), and Group B received dexmedetomidine (50 µg), combined with a standard mixture of local anesthetics. The primary outcomes included the onset and duration of motor and sensory block and lid akinesia. Secondary outcomes assessed the quality of motor and sensory block, lid akinesia using the Ocular Anesthesia Scoring System, sedation levels using the Ramsay Sedation Score, the occurrence of local or systemic complications, and satisfaction levels reported by both patients and surgeons.

Keywords: dexmedetomidine; midazolam; peribulbar block; cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cataract Disease
* Scheduled for cataract surgery
* American Society of Anesthesiologists physical status I or II.

Exclusion Criteria:

* History of allergy to any of the study medications
* Had impaired mental status
* Had coagulation abnormalities
* Had severe cardiac disease
* Had chronic obstructive lung disease
* Had a history of sleep apnea
* Refused to participate.
PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies

The objective of the study is to prospectively generate real-life data in patients aged ≥70 years treated in first line for a thoracic tumor (Non-Small-Cell Lung Carcinoma) according to best standard of care as defined by the European Society for Medical Oncology (ESMO). This cohort will aim to:

* characterize participants in terms of geriatrics, biology and carcinology
* describe the treatment modalities by stage, as well as the results in terms of efficacy, safety and impact on quality of life.

At the same time, exploratory sub-cohorts will be identified including participants treated uniformly with the same molecule, and/or the same innovative strategy.

Participants will be followed in accordance with investigator's usual clinical practice at the corresponding site. They will be asked to:

* visit the clinic as per physician's request for checkups and tests for assessing general condition and clinical efficacy and tolerance of current treatment.
* perform the necessary regular para-clinical examinations (lab testing, imaging, re-biopsy).
* provide blood samples for bio-bank repository
* perform assessments specific to older adults
* answer three quality of life questionnaires


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥70 years
* Non-small-cell lung cancer for which the multidisciplinary consultation required systemic treatment regardless of Tumor-Node-Metastasis (TNM) stage
* Patient naïve to systemic anticancer treatment for bronchial neoplasia
* Patient covered by social security
* Patient eligible for systemic treatment
* Systemic treatment with marketing authorization in the indication, available in routine care early access or compassionate access.
* Patient able to understand the protocol
* Patient not opposed to the collection of data concerning him/her
* Signature of study consent form.

Exclusion Criteria:

* Patients under guardians or curators
* Patient not under the care of the investigating center and not monitored by the investigating center
* Patient already treated with systemic therapy for NSCLC
Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging

This Protocol is intended to facilitate development and testing of new cardiovascular MRI software capabilities by UC Davis Research Faculty, as well as to facilitate the evaluation of new software capabilities provided by GE and Siemens.

This protocol will permit normal subjects, as well as patients with suspected or proven medical conditions, to undergo MRI studies using the new software capabilities. This Protocol is not restricted to imaging of a particular organ system or disease. The Protocol does not involve injection of any contrast agent, or other minimally-invasive or invasive procedure. It is intended only for those cases for which the only requirement of the subject is to relax and lie still while imaging is being performed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Ability to give informed, written consent
* Not Pregnant or breastfeeding

Exclusion Criteria:

* Electrically, magnetically, or mechanically activated implants (for example, cardiac-pacemakers)
* Ferromagnetic implant, such as an aneurysm clip, surgical clip, or prosthesis
* History of uncontrolled claustrophobia
The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy

This study was designed to assess the effectiveness of epidural patient-controlled analgesia compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain control than IV PCA even for laparoscopic gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma in stomach
* Males or Females, aged≥19 years and ≤80 years
* Scheduled as laparoscopic gastrectomy
* Patient has given their written informed consent to participate in the study

Exclusion Criteria:

* History of hypersensitivity for analgesics
* Recent history of narcotic analgesics
* Disability of central nerve system
* Uncontrolled co-morbidity
The Effect of the E-Mobile Health Application on Postpartum Adaptation

The purpose of this research is to determine the effect of the e-mobile health application on postpartum adaptation. The study will consist of two groups: Experimental group and control group.

This is a randomized controlled trial. A questionnaire and The Postpartum Self-Evaluation Questionnaire will be used to collect data. The main hypothesis of the research: Postpartum Self-Evaluation Questionnaire total mean score of women who use e-mobile health application created according to Roy's Adaptation Model is not different from the total mean score of women in the control group.

Research sample will consist of a total of 62 pregnant women, 31 in the experimental group and 31 in the control group. The data will be evaluated with the SPSS (Statistical Package of SocialSciences) 24.0 package program.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous
* Being in the 32nd week of pregnancy and above
* Not getting any diagnosis that poses a risk for pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation)
* Speaking Turkish
* To be at least a primary school graduate
* Having a smart phone with Android operating system

Exclusion Criteria:

* Multiparous
* Being under 32 weeks of pregnancy
* Getting any diagnosis that poses a risk to pregnancy (Multiple pregnancy, Gestational Diabetes, Preeclampsia, Eclampsia, Placenta Previa, Fetal Anomaly, Intrauterine Growth Retardation)
* Not speaking Turkish
* Having a smartphone with an operating system other than Android