cyrilzakka/clinical-trials huggingface dataset:
To Compare the Analgesic Effects of Different Nerve Block Analgesia Methods in Thoracoscopic Surgery

Comparison of analgesic effects of ultrasound-guided thoracic paravertebral block, erector spinae muscle block, thoracic paravertebral block combined with erector spinae muscle block, and intercostal nerve block in thoracoscopic surgery

120 patients undergoing elective thoracoscopic surgery were randomly divided into ESPB group (E group, n=30), TPVB group (T group, n=30), ESPB combine with TPVB group (ET group, n=30), ICNB group (I group, n=30). Patients in ESPB group underwent erector spinal block under ultrasound after anesthesia induction; Patients in TPVB group received thoracic paravertebral nerve block after anesthesia induction; Patients in ESPB group combined with TPVB group received thoracic paravertebral nerve block combined with erectoralis muscle block after anesthesia induction; Patients in INB group received intraoperative intercostal nerve block by the operator. All groups of patients received postoperative controlled intravenous analgesia (PCIA). Visual analogue scale (VAS) was used to evaluate the degree of pain 1h (T1), 24h (T2) and 48h (T3) after surgery. The mean arterial pressure (MAP), heart rate at T1-T3 were recorded, as well as the number of effective analgesic pump compression, the amount of sufentanil and the number of relief analgesia within 48h after surgery. The occurrence of postoperative adverse reactions such as nausea, vomiting, dizziness, retention time of thoracic drainage tube, postoperative hospital stay and postoperative pulmonary complications (pneumonia, atelectasis, pleural effusion, respiratory failure, etc.) were recorded.

Eligibility Criteria:
Inclusion Criteria:

* (1) American Society of Anesthesiologists (ASA) Grade I-II; (2) Age: 18-70 years old (3) double-hole thoracic surgery was performed; (4) Agree to participate in this study and sign the informed consent.

Exclusion Criteria:

* (1) People who are allergic to anesthetics used in this study; (2) Patients with coagulation disorders (3) patients with severe heart disease, liver or renal insufficiency; (4) have a history of chronic pain or chronic opioid users (5) have a co-existing mental illness and are not fully capable of cooperating
Locomotor Learning in Infants at High Risk for Cerebral Palsy

The objective of this project is to characterize the evolution of locomotor learning over the first 18 months of life in infants at high risk for cerebral palsy (CP). To characterize how locomotor skill is learned (or not learned) during this critical period, the investigators will combine established protocols using robust, unbiased robotic and sensor technology to longitudinally study infant movement across three consecutive stages during the development of impaired human motor control - early spontaneous movement, prone locomotion (crawling), and upright locomotion (walking).

Early spontaneous leg movements will be measured monthly from 1-4 months of age. Infants who remain at high risk for CP by month 4 as measured by the General Movements Assessment and the Test of Infant Motor Performance (TIMP) at 4 months of age will continue to locomotor training phases. Prone locomotor training using the Self-Initiated Prone Progression Crawler (SIPPC) will be delivered from 5-9 months of age. Upright locomotor training with dynamic weight support (DWS) will be delivered from 9-18 months of age. Repeated assessments of locomotor skill, movement quality, training characteristics, and variables that may mediate locomotor learning will be collected at time points from 1 month to 18 months of post-term age.

Investigators will examine the relationships between motor error and locomotor skill acquisition over time, anticipating that experiencing and correcting movement errors is critical to skill acquisition in infants at risk for CP; the contribution of other training characteristics (movement time, movement variability, and postural control) to locomotor learning; and how learning is mediated by neurobehavioral factors outside of training. Investigators will develop comprehensive models of training predictors and mediators for prone and upright locomotor learning.

Eligibility Criteria:
Inclusion Criteria:

* less than 6 weeks of age (corrected for prematurity, if applicable)
* have a history of an early brain injury associated with high risk for cerebral palsy including periventricular leukomalacia, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, hydrocephalus, stroke, neonatal seizures, or intracranial cystic lesion
* family is able to commit to study visits

Exclusion Criteria:

\* known genetic condition unrelated to cerebral palsy (CP) or congenital abnormalities

Infants with fidgety movements on the General Movements Assessments (GMA) at 3 months of age or a score greater than -0.5sd below the mean on the Test of Infant Motor Performance at 4 months of age will not progress in the study because these infants are unlikely to have CP.
RCT Comparing Remimazolam With Propofol Under EEG DSA Guidance During Cardiac Electrophysiology Studies and Ablation

Brief Summary:

The goal of this RCT is to compare the Safety and efficacy of remimazolam compared with propofol under EEG DSA guiding during cardiac electrophysiology studies and ablation. The main questions it aims to answer are:

* Is Remimazolam as efficacy as propofol in cardiac electrophysiology studies and ablation?
* Is Remimazolam lower hypotension episodes or lower vasopressor dosages compare with propofol in cardiac electrophysiology studies and ablation? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\].

Researchers will compare Remimazolam to Propofol to see if Remimazolam is more feasible in cardiac electrophysiology studies and ablation.

Participants will receive either Remimazolam or Propofol sedation during study period.


Eligibility Criteria:
Inclusion Criteria:

* Patient receives scheduled cardiac electrophysiology studies and ablation by the same cardiologist(one of the study investigator).

Exclusion Criteria:

* With existing vasopressor or shock status
* Patient refusal or cannot finish Mini-Cog or QoR-15 preoperatively
* Canceled by cardiologist
* Allergy history to the anesthetics used in this study
* History of abnormal lung function or required oxygen therapy preoperative
Resting Energy Expenditure of the COronaVirus (COVID19) Patient in Reanimation Context

Compare the resting energy expenditure of COVID-19 patients (obese or non-obese) in intensive care unit with mechanical ventilation to a control group of non-COVID-19 intensive care patients.


Eligibility Criteria:
Inclusion Criteria:

For the Ambulatory Obese Control Group, the inclusion criteria are:

* Age ≥ 18 years;
* Patient followed in the nutrition service;
* Patient who benefited from an indirect calorimetry whatever the indication between 01/01/20 and 31/12/2020;
* BMI\> 30.

For the COVID Group and the Resuscitation Control Group, the inclusion criteria are:

* Age ≥ 18 years;
* Patient having undergone a resuscitation stay
* Patient on mechanical ventilation (intubated or tracheotomized) during their stay in intensive care;
* Patient having benefited from an indirect calorimetry upon arrival in intensive care;

Only for the COVID Group:

* Patient hospitalized in intensive care for COVID 19 infection diagnosed by a positive PCR via nasopharyngeal sampling or endotracheal aspiration.
* Patient who has not yet carried out his post-resuscitation visit;

Only for the Resuscitation Control Group:

- Patient hospitalized in intensive care for an indication other than an infectious cause.

Exclusion Criteria:

Non-inclusion criteria for the Ambulatory Obese Control Group:

* Person deprived of liberty;
* Person subject to legal protection measures;
* Patient's opposition to participate in research.

The non-inclusion criteria for the COVID Group and the Resuscitation Control Group:

* For patients intubated during the resuscitation stay Fi02\> 70% which does not allow a correct interpretation of the calorimetry;
* Pregnancy ;
* Person deprived of liberty;
* Person subject to legal protection measures;
* Opposition of the patient or the person of trust to participate in the research.

Only for the COVID Group:

* Contraindication to indirect calorimetry (claustrophobia for post-resuscitation patients where calorimetry is performed with a mask);
* Contraindication to bioimpedancemetry (electronic implants, limb amputation, weight \<30kg or\> 300kg);
Effectiveness of Atkins Diet for Weight Loss

Dr. Atkins' New Diet Revolution has sold over 10 million copies and has been on the New York Times best seller list for 158 weeks. This and other low-carbohydrate diets, such as the ZONE, Sugar Busters, and the Carbohydrate Addicts Diet, have attracted much popular attention but little scientific evaluation. Given the widespread use of these diets, it seems prudent to evaluate them both for safety and efficacy. Therefore, the purpose of the study is to compare the effectiveness of two different weight control programs over the course of 52 weeks. These two programs are 1) the Atkins' New Diet Revolution, a low-carbohydrate, high-protein diet, and 2) Brownell's LEARN Program, a high carbohydrate, low fat diet based on behavior modification. Specifically, this study will compare short-term changes in weight, food intake, blood chemistries and mood in adult males (n=10) and females (n=10) who are randomized to either the Atkins' Diet or the LEARN Program for a period of one year. During this year, they will be under medical supervision. We will examine the effect of the two weight loss plans on changes in lipids, blood pressure, insulin sensitivity and ketones, and eating behavior. This is a feasibility study and thus the data will ultimately be used to design a large randomized trial with adequate statistical power.


Eligibility Criteria:
- BMI 25-40 kg/m2 inclusive
Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy.

The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria,
* Able to walk 25 feet unassisted or with minimal assistance;
* On stable doses of Parkinson's medications for at least 2 weeks prior to study onset;
* Endurance sufficient to stand at least 20 minutes unassisted per patient report.

Exclusion Criteria:

* Other significant neurological or orthopedic problems.
Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR) results to a high cancer cure rate and a good functional recovery. However, this long complex procedure is accompanied with considerable complications. Excessive fluid administration during this type of surgery has been connected with poor results. There is growing evidence that goal-directed fluid management (GDFM) might improve the results in high-risk patients.

Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume administered to patients undergoing head and neck reconstructive surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Signed informed consent

Exclusion Criteria:

* History CHF
* Severe valvular heart defects, intra cardiac shunts
* Irregular heart rhythm
* Allergy to hydroxyethyl starch solutions
* Coagulation abnormalities (INR\>1.5, aPTT\>40s, platelet count\<100x10 9/L
* History of severe bleeding disorders
* Renal insufficiency with creatinine \>200Umol/L
* Pregnant of nursing women
* History of skin disorders that are accompanied by chronic puritis
Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention

The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.

A pragmatic cluster randomised control trial will be conducted to evaluate the effectiveness of the IMA intervention in comparison to usual care, in the increase of initiation of medicines for CVD and diabetes (antihypertensive, lipid-lowering, antidiabetic and antiplatelet medications) prescribed in Primary Care (PC). The impact of the IMA intervention on secondary adherence and clinical indicators will be evaluated.

A multicenter pragmatic RCT, with cluster allocation and 2 parallel branches (IMA intervention vs. usual care) based on health records or RWD will be conducted.

PC centres' personnel, including general practitioners (GP), nurses and community pharmacists, from different areas around Catalonia (Spain), will be cluster randomised 1:1 into intervention and control groups, stratified according to the type of PC centre, either rural or urban and taking into consideration the size and localization of the PC centre and the main predictors of non-initiation (socioeconomic status, mean age, % immigrant population of the PC centre).

The IMA intervention will provide clinicians with knowledge, skills and tools to help the patient make an informed decision. PC centre personnel in the intervention group will receive training on medication non-initiation, communication abilities, health literacy, shared decision making and the use of support tools such as leaflets and the IMA website.

Eligibility Criteria:
Inclusion Criteria:

* Primary Care health professionals and pharmacists who:
* Agree to participate in the clinical trial and process evaluation.
* Attend the training course
* Are not plannig to be on sick leave during the study period (e.g. maternity leave).
* Patients who:
* Are prescribed a new treatment of cardiovascular disease o diabetes by a doctor who participates in the clinical trial.
* Are \>18 years old
* Do not reject to participate
Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. It has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of colon and rectum
* No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy
* Advanced, metastatic or recurrent not amenable to curative local therapy
* Measurable lesion(s)
* ECOG performance status 0 to 2
* Normal marrow, hepatic and renal function
* Provision of written informed consent

Exclusion Criteria:

* Active infection and/or severe comorbidity
* Known history of anaphylaxis of any origin
An Observational Study of Statin Treatment Induced HDL Changes

The aim with this study is to investigate the effect of statin induced changes in HDL-C on all cause mortality and CVD with adjustment for changes in other blood lipids and clinical parameters in Sweden, UK and the Netherlands.

An observational study of statin treatment induced HDL changes - effect on cardiovascular disease

Eligibility Criteria:
Inclusion Criteria:

* Started treatment with statins within the observation period (2004-2010)
* The patient must have valid baseline and follow-up measurements for HDL-C and LDL-C.

Exclusion Criteria:

* Malignancy Alcohol abuse/alcohol dependence
Usefulness of Post-Operative Radiotherapy in High-grade Cutaneous Squamous Cell Carcinoma: an Observational Study

Post-operative radiotherapy (PORT) is currently considered as the second most important therapy to treat high-grade cutaneous squamous cell carcinoma. Nonetheless, only few studies evaluate its impact on recurrence rate and the major part of those ones do not include a proper control group of patients.

Most recent guide lines from NCCN, Sidemast and British associations of dermatologists suggest clinicians to offer or consider PORT in selected patients but class nor level of evidence of those guide lines are provided.

This project evaluates impact of post-operative radiotherapy on recurrence rate and overall survival by comparing two cohort of patients, the former who accepted PORT and the latter who, nonetheless its necessity, decided to not undergo it.

The hypothesis which this project will answer concerns the effectiveness of post-operative radiotherapy in preventing local and regional recurrences. We expect a significant decrease of recurrence rate in patients who undergo this therapeutic option as compared to those with clinical indication but do not undergo PORT.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of high-grade cutaneous squamous cell carcinoma
* patients eligible for post-operative radiotherapy
* minimum follow-up of 24 months

Exclusion Criteria:

* lack of clinical of histological data
* impossibility of a proper follow-up
* occurrence of intermediate events (i.e., pregnancy)
Outpatient Service for Mid-trimester Termination of Pregnancy

This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours until the abortion is achieved.


Eligibility Criteria:
Inclusion Criteria:

* Have an ongoing pregnancy of 13-18 weeks gestation
* Meet legal criteria to obtain an abortion at 13-18 weeks gestation (legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman)
* Has access to a phone where she can be reached at the 2-week follow-up
* Be willing to follow study procedures

Exclusion Criteria:

* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery
* More than one prior cesarean delivery
* Living more than 2 hours away from the hospital
Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment

To determine the response rate in patients with metastatic colorectal cancer who failed treatment with a 5-Fluorouracil/Leucovorin regimen and up to one other chemotherapeutic regimen (not including adjuvant chemotherapy).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
* Stage IV or recurrent disease
* Measurable disease
* Disease progression or recurrence during or after completion of prior first-line chemotherapy with fluorouracil and leucovorin calcium (5-FU/LV)
* Prior irinotecan or oxaliplatin as part of the 5-FU/LV regimen or as subsequent therapy allowed
* Only 2 prior regimens for metastatic disease allowed
* One additional regimen as adjuvant therapy allowed provided patient remained disease-free for \> 6 months after completion of therapy\*
* Newer, targeted investigational agents (e.g., cetuximab or bevacizumab) are not

counted as a chemotherapeutic regimen unless used in combination with a cytotoxic regimen NOTE: \*If evidence of failure occurred within \< 6 months after completion of adjuvant therapy, patients may have received only 1 additional regimen for metastatic disease

* No active brain metastases (requiring treatment or progressing)

Exclusion Criteria:

* History of blood transfusion within 14 days
* Need of concurrent Administration of allopurinol
* History of Radiotherapy or Chemotherapy within 4 weeks
* Any psychological or sociological condition, addidtive disorder or family problems that might preclude compliance with the protocol
* Any unstable or severe intercurrent medical condition that in the opinion of th einvestigator might interfere with achievement of study objectives
* Receipt of an investigational agent within 28 days prior to first day of dosing with AG-2037
* Pregnant or breast feeding
* Previous treatment with GARFT inhibitors
* History of a malignancy (other than colorectal cancer) excpet those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
* Active brain metastases (requiring treatment or progression)
Family History Study of Alcohol Consumption Using Memantine

The purpose of this study is to evaluate the effects of the study medication, memantine (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. We hypothesize that memantine will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period. We will also evaluate the influence of family history of alcoholism on the efficacy of memantine in reducing alcohol drinking behavior.


Eligibility Criteria:
Inclusion Criteria:

* Ages 21-50
* Able to read English at 6th grade level or higher and to complete study evaluations
* Regular alcohol drinker

Exclusion Criteria:

* Individuals who are seeking alcohol treatment
* Medical conditions that would contraindicate the use of memantine
* Regular use of other substances