cyrilzakka/clinical-trials huggingface dataset:
Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement

The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal postoperative analgesia. However, many adverse effects and complications have been reported due to its proximity to vital structures. Because of these shortcomings, an alternative to block the LP nerves is required.

In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the efficacy of LPB and SFIB in this setting.

Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after THA. The hypothesis is that both blocks would result in similar postoperative opioid (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence trial.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35 (kg/m2)

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy (assessed by history and physical examination)
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* Allergy to local anesthetics (LAs) or morphine
* Pregnancy
* Prior surgery in the corresponding side of the lumbar o suprainguinal area
* Chronic pain syndromes requiring opioid intake at home
Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients

For non-diabetic patients undergoing gastrointestinal surgery, preoperative oral carbohydrate improves postoperative recovery. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.

Studies show that avoiding long-time fasting by oral carbohydrates 2 hours before surgery attenuates discomfort and anxiety; it also reduces stress, insulin resistance and catabolism in patients undergoing gastrointestinal surgery, resulting in earlier recovery of gastrointestinal function and short length of hospital stay after surgery. However, for diabetic patients scheduled to undergo gastrointestinal surgery, the risks and benefits of preopertive oral carbohydrate remain unclear. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 years and beyond;
2. Diagnosed with type 2 diabetes before surgery;
3. Scheduled to undergo elective gastrointestinal surgery with anticipated duration of 2 hours or more;
4. Provide signed writen informed consents.

Exclusion Criteria:

1. Refuse to participate in the study;
2. Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy;
3. Previous history of total or partial gastrectomy;
4. Preoperative New York Heart Assocition (NYHA) class IV, renal failure (requirement of renal replacement therapy), severe hepatic disease (Child-Pugh class C), or American Society of Anesthesiologists (ASA) class IV or higher;
5. Preoperative pyloric and/or intestinal obstruction;
6. Combined surgery on other intra-abdominal organs or other parts of the body.
NoL Index Variations Before and After a Stellate Ganglion Block

To evaluate and compare the NoL index variations after a painful physiotherapy exercise in patients with upper limb CRPS, before and after a stellate ganglion block.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of upper limb CRPS according to the Budapest criteria12, for more than 6 months;
* Significant pain relief from stellate ganglion block;
* Undergoing physical therapy;
* 18 years and older.

Exclusion Criteria:

* Patients taking beta blockers

  * Bilateral/generalized CRPS
  * Patients needing sedation for the procedure
  * Inability to understand a Numeric Pain rating Scale due to cognitive dysfunction or linguistic barrier
  * Movement disorder making a person unable to lie still for the duration of the evaluation period.
  * Patient refusal
Relative Bioavailability of BMS-931699 From Prefilled Syringe Compared to Drug in Vial

A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to drug in vial


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
* All participants must have hemoglobin, hematocrit, and platelets within normal limits at screening
* All participants must have activated partial thromboplastin time, prothrombin time, and international normalized ratio within normal limits at screening

Exclusion Criteria:

* Any current or past history or risk for tuberculosis:
* Active tuberculosis requiring treatment within the previous 3 years. All participants will be required to have a QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed at screening. Also excluded are participants with evidence of a past tuberculosis infection without documented adequate therapy. Participants with a positive QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test at screening will not be eligible for the study. A QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed within 4 weeks of dosing on Day 1 is acceptable as long as there is documentation of a negative result.
* Current clinical, radiographic, or laboratory evidence of active tuberculosis
* A history of herpes zoster
Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing

This is an observational, controlled, single-centre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for disproportionate breathlessness. The core methodology involves capturing of data during a short period of measurement of breathing using SLP.

Cohort A: This study is a pilot study with four study visits (Screening, Baseline, week 13 and week 26) to generate data to characterise the tidal breathing patterns and parameters with Thora3Di™. Subjects will have a screening visit within 0 to 14 days prior to the first study visit. For each study visit, subjects will be seen in the clinical research facility and have two 5-minute SLP measurements (at rest and on exertion). The SLP measurement should be performed prior to standard lung function tests with minimal impact on clinical time and not change to hospital attendance. Also, each visit subjects will be asked to report concomitant medications and adverse events, and fill several questionnaires forms as outlined in the SOAs.

Cohort B: Healthy subjects will have only one visit for this study. After signing the informed consent form, subjects will undergo two 5-minutes SLP measurements (at rest and on exertion).

Eligibility Criteria:
Inclusion Criteria:

* • Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO).

  * Cohort B: Any adult who is in good respiratory health will be considered for inclusion as a normal in the study.

Exclusion Criteria:

* Subject unable to sit in an upright position for required period

  * Subjects with significant co morbidities (assessed by the clinician at screening only):
  * Chest wall or spinal deformity e.g. scoliosis OSA, Apnoea hypopnoea index \> 30 (if known)
  * Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participants' ability to participate in the study
  * BMI \> 40
  * Height \> 194 cm
  * Female participant who is pregnant, lactating or planning pregnancy during the course of the study
  * Inability to consent/comply with trial protocol
Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size.

The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects.

This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic cancer will be treated in this trial, which is estimated to be carried out during a time period of 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Cytohistological diagnosis of ductal pancreatic adenocarcinoma .
* Stage III disease (see above).
* The patient is not a candidate for continued chemotherapy or (chemo)radiotherapy due to lack of demonstrable efficiency or to the side effects of the drugs.
* Age between 18 and 80 years.
* Anticipated compliance with treatment and follow-up.
* Double informed consent for both imILT and possible surgery with radical intent (in the event of pre-operative overstaging).
* At least a part of the tumor can be treated with imILT without damage to surrounding vital structures.
* Have an ECOG performance status \< 1 (l'Eastern Cooperative Oncology Group)

Exclusion Criteria:

* Not a candidate for laparotomy.
* Becoming resectable after neoadjuvant chemotherapy.
* Other simultaneous treatments for the same neoplasm.
* Simultaneous other malignancies except for basal cell carcinoma.
* HIV positive.
* Active autoimmune disease.
* Systemic corticosteroid medication.
* Pregnancy or nursing.
Oral Anticoagulation and Self-management

An intervention program targeting patients and caregivers based on education about their condition and training in the use of portable coagulomenter to self monitor and training on the treatment adjustment to self manage, can be effective to enable patients in OACs to self manage as well as to identify determinant factors associated with the success and failure of the program.

BACKGROUND: The skills of patients on oral anticoagulants are critical for achieving good outcomes with this treatment. Self-management, or the capacity of patients to control their INR (International Normalized Ratio)level and adjust their treatment, is an effective strategy of treatment. Capacity of patients to self manage is determined by a range of factors. The identification of these factors would improve the design of self management programmes and in turn increase the number of patients able to self-manage. The objective of our study is to identify those factors that determine the ability of patients on oral anticoagulant therapy to achieve self-management of their treatment.

METHOD: This will be a three year quasi- experimental prospective study with a control group. 333 patients on anticoagulant therapy from five health centres of the Basque Health Service are to be followed up for a period of six months each after the intervention, to assess their ability to self-test and self-manage. The intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose.

DISCUSSION: Training programmes for self-management are effective in terms of enabling patients to acquire the necessary skills, though the level of success seems to depend on various patient-related factors. Given the proven benefits of self-management, it would be useful to properly characterise these factors and use this information to successfully increase the percentage of patients on on oral anticoagulants able to self-manage their own treatment.

Eligibility Criteria:
Inclusion Criteria:

* Anticuagulated
* Living in the study area

Exclusion Criteria:

* Older than 16 years old
* More than one year cuagulated
Effects of a Single-bout of Moderate-intensity Aerobic Exercise on Mood and Mental Health Biomarkers in Adults with Depressive And/or Anxiety Symptoms

This study investigates whether a single session of aerobic exercise (like running) can improve the participants' mood and whether such benefits can be explained by changes in the blood factors (like hormones) and brain activity.

The main questions this study aims to answer are:

* Can a single session of aerobic exercise improve mood?
* Which changes in the blood and brain could explain the effects of exercise on mood?

Researchers will compare the participants' mood states before and after exercise to see whether exercise can improve mood.

The participants will:

* Answer questionnaires, collect blood, and undergo magnetic resonance imaging (MRI) before exercise.
* Perform 30 minutes of running on a treadmill.
* Answer the same questionnaires, collect blood, and undergo magnetic resonance imaging (MRI) after exercise.

The entire assessment will last for about 2h45min and will be performed on a single day.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects within the stipulated age range

Exclusion Criteria:

* Acute injury or illness that impairs the ability to safely exercise and/or inability to exercise with a moderate intensity;
* Metabolic and/or neurologic disorders;
* Iron implants;
* People who cannot stay still, are intolerant of noise or fearful of enclosed spaces (due to the small space inside the scanner).
Endometrial Local Injury and Implantation Failure

The purpose of this study is to evaluate the influence of endometrial biopsy on increasing implantation rate in patients with recurrent implantation failures, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group. The results suggest that in vitro fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy outcome.

In a randomized control trial study, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group.

The implantation rate was determined as 10.9% in biopsy group compared with 3.38% in controls. Clinical pregnancy rate was significantly higher in case group than controls (27.1% and 8.9% respectively

Eligibility Criteria:
Inclusion Criteria:

* women with recurrent implantation failure which was defined as 2-6 cycles unsuccessful of IVF-ET in which more than 10 high grade embryo were transferred

Exclusion Criteria:

* age over than 40 years old
* poor responders to ovarian stimulation
The Effect of Esmolol on Patients With Sepsis

The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

Severe sepsis, septic shock, and their complications have become the major healthcare problem that affects millions of people each year, resulting in high mortality rates. Septic responses have an extremely complex chain of events including inflammatory and anti-inflammatory processes, humoral and cellular reactions, and cardiocirculatory abnormalities. Esmolol may have some potential in treating septic shock and sepsis. The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

Eligibility Criteria:
Inclusion Criteria:

* sepsis patients
* HR\>100bpm 6h after admission
* with CVC and ScvO2\>65%

Exclusion Criteria:

* age \<18 years,
* used β-blocker before,
* cardiac dysrhythmias,
* need for an inotropic agent,
* valvular heart disease,
* hemoglobin\>6g/L
* pregnancy.
Budesonide 9 mg Capsules in Active UC

The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent,
* Men or women aged 18 to 75 years,
* Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
* Established disease,

Exclusion Criteria:

* Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
* Toxic megacolon or fulminant colitis,
* Colon resection,
* Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
* Malabsorption syndromes,
* Celiac disease,
* Bleeding hemorrhoids,
* Active peptic ulcer disease
* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
* Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
* Any severe infectious disease (e.g., tuberculosis, AIDS),
* Severe co-morbidity substantially reducing life expectancy,
* History of colorectal cancer,
* History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma
A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain

The purpose of the study is to see if stereotactic radiosurgery/SRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer/SCLC.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of small cell lung cancer
* Radiographic diagnosis of up to 10 brain metastases on contrast-enhanced MRI
* Age 18 and above
* Performance status KPS 60-100/ECOG 0-2
* Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment
* The patient or legally authorized representative is able to provide informed consent

Exclusion Criteria:

* Unable to undergo contrast-enhanced MRI brain or spine
* Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine
* Pregnant or lactating women
* Prior brain-directed radiotherapy
* Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET/CT imaging, no more than 3 months before study enrollment
PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma

This is a prospective, multicenter, open label Phase II Clinical Trial. 30 advanced poorly differentiated thyroid carcinoma patients who were histopathologically confirmed inoperable were enrolled in this study.

Subjects will receive the treatment regimen as follow:

intravenous infusion of liposomal doxorubicin 35 mg/m2, d1; cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles. Stop the treatment if the patients have progressed or intolerated to the toxicity. The primary endpoint is disease control rate(DCR), the secondary endpoint is overall survival (OS), progression-free survival (PFS), safety and quality of life assessment(QoL).

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate and sign the informed consent form;
2. Age :18-70 years old;
3. Histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma;
4. Previously received surgery, I131 treatment, radiotherapy, chemotherapy patients can be enrolled；
5. At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST 1.1);
6. Expected survival time ≥ 3 months;
7. Karnofsky score ≥70;
8. Blood test：ANC ≥1.5×109/L； PLT ≥75×109/L；Hb ≥90g/L;
9. Liver function:Serum bilirubin (SB) level:≤ normal upper limit（ULN）2 times; aspartate aminotransferase(AST) and alanine aminotransferase(ALT) ≤ ULN 2.5times; or ≤ ULN 5times if Liver metastases are present;
10. Renal function: Serum creatinine ≤ ULN 1.5times;
11. LVEF ≥ 50%;
12. No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, noncancerous fever \> 38℃;
13. Subjects are well-behaved, able to undergo the follow-up efficacy and adverse reactions according to the program requirements.

Exclusion Criteria:

1. Active or uncontrolled severe infection (≥CTCAE grade 2 infection)；
2. Previously received anthracycline-based regimen: the cumulative dose of doxorubicin at or above 500 mg / m2 or the cumulative dose of epirubicin reached or exceeded 800 mg / m2;
3. The New York Heart Association (NYHA) graded class II or above heart disease patients previously or at present;
4. Patients with CNS disorders or CNS metastases;
5. Allergic to chemotherapeutic drugs or their excipients or intolerant patients;
6. Received any other test drug treatment within 30 days of the first chemotherapy administration;
7. Pregnant or lactating women;
8. Arterial/venous thrombosis occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism;
9. History of aneurysm;
10. Neurological disorders with a history of epilepsy or ataxia require treatment;
11. A history of drug abuse and incapable of abstinence or mental disorder;
12. A history of peripheral neuropathy and the muscle strength is below level 3;
13. Suffering from other diseases and complications of hand-foot syndrome;
14. Researchers think it is not suitable for enrolling.