cyrilzakka/clinical-trials huggingface dataset:
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial

Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age.


Eligibility Criteria:
Inclusion Criteria:

1.) Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating TOWAR trial site that meet requirements for initiation of blood or blood component transfusion

AND

2A.) Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital or during transport OR

2B.) Systolic blood pressure ≤ 70mmHg at scene, at outside hospital or during transport

Exclusion Criteria:

1. Wearing NO TOWAR opt-out bracelet
2. Age \> 90 or \< 18 years of age
3. Isolated fall from standing injury mechanism
4. Known prisoner or known pregnancy
5. Traumatic arrest with \> 5 minutes of CPR without return of vital signs
6. Brain matter exposed or penetrating brain injury (GSW)
7. Isolated drowning or hanging victims
8. Objection to study voiced by subject or family member at the scene
9. Inability to obtain IV or intraosseous access
10. Isolated burns without evidence of traumatic injury
Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease

The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.

Current studies have shown that repetitive transcranial magnetic stimulation can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with stroke. The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years, regardless of gender;
2. Diagnosed with CSVD, and neuroimaging presented as recent small subcortical infarcts;
3. Initiated transcranial magnetic stimulation within 7 days of onset;
4. Subject or legal representative agreed to the treatment and signed the informed consent;

Exclusion Criteria:

1. Vascular stenosis \> 50% diagnosed by Transcranial Doppler (TCD) and carotid ultrasound;
2. Previous history of atrial fibrillation or myocardial infarction within 6 months;
3. Moyamoya disease or hereditary cerebral small vessel disease, such as CADASIL;
4. White matter hyperintensities (WMH) of non-vascular origin;
5. Severe hepatic and renal diseases, cancer or other major diseases related to integral medical and surgical procedures;
6. Patients with contraindications to transcranial magnetic stimulation, such as metal or electronic devices in the brain;
7. Pregnant or breastfeeding women;
8. The patients with disorders of consciousness, agitation or insufficient bilateral temporal bone windows for insonation who cannot cooperate to dynamic cerebral autoregulation monitoring;
9. Previous history of epilepsy or family history of epilepsy;
10. Previous treatment with transcranial magnetic stimulation or its equivalent;
11. Unwillingness to be followed up or poor adherence to treatment;
12. Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment, or who have participated in this study;
13. Other conditions that the investigators deemed unsuitable for enrollment.
Chemotherapy Related Anemia

This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a non-myeloid malignancy
* Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug
* Screening hemoglobin concentration less than or equal to 11.0g/dL
* ECOG performance status of 0 to 2
* Adequate renal and liver function

Exclusion Criteria:

* History of seizure disorder
* Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1
* More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1
Combined Compared to Sequential Cognitive and Physical Training in Anterior Cruciate Ligament Reconstructed Individuals

The goal of this clinical trial is to investigate changes in cognitive and physical performance after 10 weeks of dual or single task training in anterior cruciate ligament (ACL) reconstructed individuals. The main questions it aims to answer are:

* Does cognitive performance in ACL reconstructed individuals change after multiple training sessions incorporating single versus dual-task?
* Does physical performance and intrinsic motivation for training change over the course of 10 weeks when performing single versus dual-task training sessions?
* What movement patterns do ACL reconstructed individuals show during a dual-task training in an immersive environment?

Researchers will compare a combined dual-task training (combined physical and cognitive training) to a single task training (physical and cognitive training separately) to see if there are changes on cognitive performance depending on the training type.

Participants will:

* Perform dual-task or single task training twice per week for 10 weeks
* Visit the clinic before and after the training period for tests
* Visit the movement laboratory once for analysis of movement patterns


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* At least 6 months after ACL injury
* Surgically reconstructed ACL
* At least 2 hours of sports participation before the injury
* Written consent of the attending surgeon to perform intensified training methods including one-legged jumps at 6 months after surgery after the first visit
* Ability to give informed consent as documented by signature
* Ability to understand instructions in German or English
* BMI \< 28 kg/m\^2
* Availability to take part in at least 70% of all training sessions

Exclusion Criteria:

* Surgery on the contralateral leg during the last 12 months
* Acute or chronic musculoskeletal, neurological, or cardiopulmonary disorders
* Unadjusted vision problems
* Concussion during the last 6 months
* Pregnancy
* Breastfeeding
* Amputation
* Inflammatory pain or swelling during exercising
Magnetic Stimulation to Treat VT Storm

Ventricular Tachycardia storm is a medical emergency characterized by three or more episodes of ventricular arrhythmia within 24 hours and associated with a significantly increased mortality and massive health resource utilization. Several therapies are utilized including sympathetic blockade (through deep sedation and beta blockers), antiarrhythmic drugs, implantable cardioverter defibrillator (ICD) reprograming where applicable, and catheter ablation. Despite standard intervention, mortality rates remain high and additional therapeutic options are actively being investigated.

The overall objective of this proposal is to investigate whether transcutaneous magnetic stimulation designed to inhibit the left stellate ganglion can be used in this population. This is a single-center, randomized, sham-controlled trial to assess the efficacy of transcutaneous magnetic stimulation of the left stellate ganglion to treat patients with ventricular tachycardia storm.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 3 episodes of VT in 24 hours

Exclusion Criteria:

* Pregnancy
* Implanted ventricular assist device
* Metal implanted in head or neck (except the mouth)
* Implanted medication pumps
* Cochlear implant
* Implanted brain stimulator
* Ocular implant
* History of active malignancy in region of stimulation (neck)
Laparoscopic Transversus Abdominis Plane (TAP) Block to Reduce Post-operative Opioids

In this study we aim to investigate the efficacy of laparoscopic-guided TAP block in reducing post-operative opioid use following minimally invasive foregut and bariatric surgeries. We will also compare and report the analgesia produced by Bupivacaine HCL vs Exparel ®, a prolonged slow release Liposomal Bupivacaine formulation. Secondary outcomes assessed will be VAS pain scores, length of stay, and PONV dosage administered.


Eligibility Criteria:
Inclusion Criteria:

* gastric bypass \& sleeve gastrectomy, duodenal switch and minimally invasive elective anti-reflux foregut surgeries such as - hiatal hernia repair, fundoplication and Heller myotomy.

Exclusion Criteria:

* Subjects who are known to be i. Allergic to Bupivacaine ii. Chronic opioid users Page 4 iii. Had/have neurological conditions iv. Have a diagnosis of chronic pain syndrome which requires them to consume regular analgesics \> 3-months v. American Society of Anesthesiologists (ASA) Class IV \& V patients with severe systemic disease that is a constant threat to life.

vi. Patients with abdominal drain use vii. Patients with significant cardiovascular, liver or renal disease viii. Presence of contraindications for bariatric or foregut surgery. ix. Patients presenting postoperative complications will be excluded from final analysis \& final data set x. History of bariatric or foregut surgery xi. Patients who are pregnant xii. Patients who are under the age of 18
Does Protein and Fat Content of Meal Increase Glucose Concentrations

The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients with type 1 diabetes (T1D) on basal-bolus insulin therapy.

In this single center, crossover, randomized, controlled study, control meal (SM: standard meal using carbohydrate counting method) and three test meals (HPM: high protein meal using carbohydrate counting method, HPFM-a: high protein-fat meal using carbohydrate counting method and HPFM-b: high protein-fat meal using carbohydrate and fat-protein counting method) were compared on postprandial early (0-120 minutes), late (120-240 minutes) and total (0-240 minutes) glucose response.

Eligibility Criteria:
Inclusion Criteria:

Subjects:

* had Type1 Diabetes for at least 1 years;
* use multiple dose (basal-bolus) insulin therapy;
* use fast-acting insulin analogs (lispro, glulisine, and aspart) and basal insulin analogs (detemir, glargine);
* daily inslin dose ≥0.5 IU/kg/day.

Exclusion Criteria:

Subjects:

* had any restrictive food intake disorders (eg celiac disease or food allergy);
* had any diabetes complications (eg neuropathy, nephropathy or retinopathy);
* diagnosed for \<1 year;
* were using corticosteroid or any medication that could effect gastric emptying;
* did exercise or had hypoglycemia or ketoacidosis within 24 hour before the test meals;
* had overweight or obese (BMI z score: ≥ 1SD and ≥ 2SD respectively);
* had not on follicular or peri-ovulatory phases of their menstrual cycles (for females).
Validity and Reliability Study of the Muscle Excitability Scale in Spinal Cord Injury Patients

The aim of the study is to verify validity and reliability of the Muscle excitability scale (MES), which has been developed to access muscle susceptibility to spasms and/or clones as part of spastic motor behavior in spinal cord injured patients.

The muscle excitability scale (MES) is intended for patients after spinal cord injury. The objective is to evaluate a motor response (muscle spasms or clones) to a sensory or motor stimulus. A sensory stimulus is created by thumb and pointfinger compression of cutaneous tissue on the inside part of the middle thigh and calf. A motor stimulus is created by passive movement of the lower limb to flexion and extension. The MES grades from 0 to 4 reflect the muscle spastic or clonic tendency and the extent of this motor response (from isolated to generalized). Two investigators will examine a spastic motor behavior in 50 chronic SCI subjects using MES, Modificated Ashworth Scale (MAS) and Penn Spasms Frequency Scale (PSFS) to verify the validity and reliability of the MES.

Eligibility Criteria:
Inclusion Criteria:

* Spasticity in Spinal Cord Injury

Exclusion Criteria:

* Parallel brain injury
* Cognitive deficit affecting cooperation
* Acute infection or other sudden complication
* Recent change of antispastic medication
Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)

The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).

The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older
* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned
* Visual potential in both eyes of 20/30 Snellen or better after cataract removal and IOL implantation
* Preoperative corneal astigmatism of 1.5 diopters or less

Exclusion Criteria:

* Use of systemic or ocular medications that may affect vision
* Uncontrolled systemic or recurrent ocular disease
* Requiring an intraocular lens \<15.0 or \>26.0 diopters
* Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates
* History of ocular trauma or prior ocular surgery
* Known pathology that may affect visual acuity or visual field
* Corneal abnormalities
* Pupil abnormalities
* Capsule or zonular abnormalities
Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children

At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Researchers have clarified that the addition of dexamethasone to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of dexamethasone to local infiltration for patients receiving craniotomy. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.


Eligibility Criteria:
Inclusion Criteria:

* An elective craniotomy under general anesthesia;
* American Society of Anesthesiologists (ASA) physical status of I or II;
* Participates with an anticipated fully recovery within 2 hours postoperatively;
* Informed consent by parent(s) and/or legal guardian.

Exclusion Criteria:

* History of allergies to any of the study drugs;
* Drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids;
* Psychiatric disorders;
* Uncontrolled epilepsy;
* Chronic headache;
* Peri-incisional infection;
* Body mass index exceeded the 99th percentile for age;
* Children who must use a patient-controlled analgesia (PCA) device;
* Children who cannot understand an instruction of pain scales before surgery.
FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women

Urethral pain syndrome (UPS) is defined by the occurrence of persistent or recurrent episodic urethral pain in the absence of proven infection or other obvious pathology. The objective of this study is to determine the effect of an intraurethral and vaginal laser therapy for the treatment of UPS. The hypothesis is that a significant reduction of urethral pressure pain can be achieved.

Urethral pain syndrome (UPS) is characterized by recurrent or persistent symptoms such as urethral or pelvic pain, daytime frequency and nocturia with unclear aetiology are diagnosed as UPS. Chronic infection by fastidious bacteria leading to chronic inflammation and pain may also cause UPS. Due to the unclear aetiology, the optimal treatment is challenging. It is therefore essential to find new and effective treatment options for patients suffering from UPS. Over the last few years, the use of lasers has become more popular to treat gynaecological and urogynecological conditions including stress urinary incontinence (SUI), genitourinary syndrome of menopause (GSM), vaginal prolapse and other conditions. In several trials, vaginal laser therapy has been shown to have a very good effect on SUI and GSM. Very few publications are available on the use of intraurethral laser therapy for the treatment of SUI and GSM with promising results. This is the first study to test the effect of intraurethral and vaginal laser therapy for the treatment of UPS. The hypothesis is that symptoms can be relieved in patients with UPS i.e. a reduction of urethral pressure pain upon palpation can be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Adult female, 18 years of age or older
* Urethral pressure pain upon palpation, VAS Score ≥ 2
* Intermittent or chronic pain in the urethra and/or the small pelvis (independent of micturition) for at least 6 months
* No significant improvement of UPS from at least one previous conservative treatment (pessary, antibiotics, local oestrogens etc.)
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Treatment with Isotretinoin (Acne, Rosacea) within last 6 months
* Acute urinary tract infection or other acute infection of the bladder, vagina, vulva or urinary tract detected by routine urine analysis
* Positive urethral swab for Ureaplasma, Mycoplasma or Chlamydia ≤ 6 weeks. Exception: Patients with chronic and persistent fastidious bacteria can be included six weeks after two unsuccessful treatments with antibiotics. Antibiotics therapy must also include sexual partners.
* Pre-existing bladder or urethra pathology
* Interstitial Cystitis
* Endometriosis
* Diagnosis of collagen disorders, e.g. benign joint hypermobility / Elhers-Danlos / Marfans etc.
* Vesicovaginal fistula
* Unwillingness or inability to complete follow-up schedule
* Unwillingness or inability to give informed consent
* Unwillingness or inability to complete questionnaires
Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose and Related Hormones

The investigators aimed to explore effects of dexmedetomidine on modulation of perioperative blood glucose and relevant hormone during the general anesthesia with surgery time ≥ 4 hours, and the effects on postoperative complications. 75 participants (American Society of Anesthesiologists grades I or II, of both sexes,aged 40-80 yr,with BMI of 18.5-27 kg/m2) scheduled for elective surgery under general anesthesia with surgery time ≥ 4 hours were enrolled in this study. The participants were divided into four groups: group C (control saline group, no dexmedetomidine use), group D1 (dexmedetomidine loading dose 1 mcg/kg, maintenance dose 0.25 mcg/kg/h), group D2 (dexmedetomidine loading dose 1 mcg/kg, maintenance dose 0.5 mcg/kg/h).10 minutes before anesthesia induction, all participants were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group. Blood samples were taken at the beginning of dexmedetomidine (T0), the beginning of skin incision (T1), 1 h after skin incision (T2), the end of the surgery (T3) and 1 h after patient transfer to PACU (T4) for the value of blood glucose,lactate and relevant hormones. Also, investigators also record the total amount of propofol and sufentanil at the end of surgery,and the complications within 24 h after the surgery.


Eligibility Criteria:
Inclusion Criteria:

- patients undergoing operations over 4 h under general anesthesia,ASA physical status I or II, irrespective of showing gender bias, aged between 50-75 years old, and having a body mass index (BMI) between 18.5-28 kg/m2.

Exclusion Criteria:

* the patients with bradycardia, hypoglycemia, heart disease, adrenal tumor,diabetes or showed ≥7.0 mmol/L, or HbA1c level ≥6.5%.