cyrilzakka/clinical-trials huggingface dataset:
Analgetic and Anxiolytic Effect of Preoperative Pregabalin

The purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain.

Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.

The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that gabapentin can be effective to reduce sensitization and postoperative pain. Pregabalin (S-aminomethyl-5-methylhexaninacid) is a further development of gabapentin. Pregabalin has a fewer side-effects compared with gabapentin.

The purpose of this study is to compare the analgetic and anxiolytic effect of pregabalin and placebo used as premedication.

The hypothesis is that a single-dose pregabalin (150 mg postoperatively (p.o.)) gives significant better anxiolysis and analgesia than placebo.

The study is including patients undergoing surgery of the vertebral columna.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of disc prolapse
* Age 18+
* ASA (American Association in Anesthesiology) I-III
* written consent

Exclusion Criteria:

* Age \< 18
* ASA \> III
* liver failure
* renal failure
* allergic reaction against gabapentin and/or pregabalin
* pregnancy
ECigs, Inflammation and Oxidative Stress

Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress and inflammation.

Participants will have an acute e-cig exposure on 2 occasions 1) e-cigarette 2) sham e-cig (empty e-cig) control. Blood will be collected before and after E-cig use and analyzed for biomarkers of inflammation and oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Cardiac disease Respiratory disease Diabetes
"Living Low - Training High" Methods and Physiological Responses in Well-trained Swimmers

To overcome the lack of knowledge regarding the impact of different "living low, training high" methods on swimming performance, a 4-week intervention will be carried out to determine and compare the effects of three Repeated Sprints in Hypoxia (RSH) methods with each other and with a control group. Our goal is to characterize and compare the adaptations in swimming performance and in cardiorespiratory, metabolic, and muscle oxygenation responses that can arise after a 4-week training period of RSH and RSH-voluntary hypoventilation (VHL) performed in a ski-ergometer.

Recently, several new "living low training high" (LLTH) methods involving repeated sprints in hypoxia have shown promising results, especially in team sports. However, the underlying mechanisms remain mostly unclear, as does its effectiveness in improving swimming performance.

Hypoxemia can be induced by exposure to ambient hypoxia conditions, by voluntary hypoventilation at low lung volume, or by vascular occlusion (namely, blood flow restriction). Swimming performance is influenced by aerobic and anaerobic metabolism and could benefit from these different LLTH methods.

This project aims to compare the effects of repeated sprint training performed with a ski-ergometer 1) in a hypoxic chamber and 2) with voluntary hypoventilation on the performance of swimmers, as well as to characterize cardiorespiratory, metabolic, and muscle oxygenation adaptations that may contribute to the improvements achieved after four weeks of each of these types of training.

All groups will be evaluated before and after the supervised training period in three testing sessions in normoxia, separated by at least 24 hours within 7 days. Swimmers will perform: 1) time-trial (100 m front crawl) in the swimming pool to determine performance, V̇̇O2 peak, and lactate concentration following the test; 2) incremental test to exhaustion in the swim-ergometer to determine aerobic peak power, cardiorespiratory responses (V̇̇O2max, ventilatory thresholds), and maximal tissue deoxygenation; 3) time-trial test in the ski-ergometer (100 m) to access performance, muscle and pulmonary oxygen uptake kinetics, and the relative contribution of energetic systems.

Training sessions will be performed in the ski-ergometer and consist of 4 sets of 5x6s all-out sprints with 24s and 5 min of passive rest between the sprints and sets, respectively. In all testing and training sessions, pulse oxygen saturation will be measured for safety purposes.

Eligibility Criteria:
Inclusion Criteria:

* Swimmers from both sexes;
* With regular participation in National Championships;
* More than five years of training experience;
* No recent exposure/acclimatization to altitude;
* No recent exposition to Blood Flow Restriction training.

Exclusion Criteria:

* athletes who had an acclimatization experience or exposure to altitude lasting more than 10 days in the last 6 months;
* pregnant or postpartum women;
Lactation Education Study in Mothers of Very Low Birth Weight Infants

This study will test the effectiveness of breast milk expression discharge instructions in digital video disc (DVD) format for home use by mothers of very low birth weight infants on the dose and duration of mother's breast milk feeding in their infants compared to breast milk expression discharge instructions in printed format. The investigators hypothesize that infants whose mothers receive breast milk expression discharge instructions via DVD will receive a larger dose of maternal breast milk and for longer duration during the initial neonatal intensive care unit hospitalization than infants whose mothers receive discharge instructions in printed format.

Very low birth weight (VLBW; \<1500 g) infants who receive maternal breast milk, as opposed to infant formula, are less likely to experience the serious illnesses and poor developmental outcomes associated with VLBW. However, a disparity exists in breast milk feeding. Infants whose mothers have low educational attainment and low income are less likely to receive maternal breast milk than infants whose mothers who do not have low educational attainment and low income. The primary objective of this proposed research is to determine the effect of lactation discharge instructions in an audio-visual format provided to mothers for home viewing on the dose and duration of maternal breast milk received by their VLBW infants during the neonatal intensive care unit hospitalization.

Methods. Forty mothers of VLBW infants will be randomly assigned to receive a breast milk expression instruction digital video disc (DVD) in addition to standard of care lactation education or assigned to receive written instructions in addition to standard of care lactation education. In addition to comparing infant intake of maternal breast milk intake, pre and post intervention lactation and breast milk expression knowledge will be compared between groups and DVD viewing frequency and acceptability will be determined with a log and questionnaire to be completed by the intervention group and collected the first month after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Infant birth weight less than 1500 grams
* Maternal educational attainment less than/equal to 12 years
* Maternal low income status (Medicaid participant prior to delivery)

Exclusion Criteria:

* Non-English speaking
* Illicit drug use during pregnancy
Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries

Postoperative nausea and vomiting (PONV) is considered one of the most unpleasant postoperative discomforts and lead to serious complications of aspiration of gastric contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. The incidence of PONV is 30-40% in normal population and touches a peak of 75-80% in certain high-risk groups. PONV is associated with delayed recovery and prolonged hospital stay and is associated with significant morbidity. It may also result in delayed discharge, which is particularly significant after potentially ambulatory surgery. Women are 2 to 3 times more susceptible to PONV than men and breast surgery, which is primarily done in an outpatient setting, is associated with high incidence of PONV, ranging between 15% and 84% in the absence of prophylactic treatment.

Nitrous oxide (N2O) has analgesic and sedative properties but may potentially increase the incidence of PONV. N2O might increase the incidence of PONV by several potential mechanisms: (1) increase in middle ear pressure (2) bowel distension, (3) activation of the dopaminergic system in the chemoreceptor trigger zone and (4) interaction with opioid receptors. N2O has been demonstrated to increase the incidence of PONV in some studies but not in others. The present study is undertaken to evaluate the effect of nitrous oxide- free general anesthesia on the undesirable clinical outcome of PONV.


Eligibility Criteria:
Inclusion Criteria:

1. ASA I and II female patients aged 18 years or over posted for Breast Surgeries under General Anesthesia in the main operating rooms

Exclusion Criteria:

1. ASA III, IV, V female patients
2. Age less than 18 years
3. Patients undergoing Breast Reconstructive Surgery
4. Patients with contraindications to Fentanyl, Diclofenac, Paracetamol, Atracurium
5. Chronic pain patients on long-term opioid medication
6. Use of regional anesthetic technique (e.g. Paravertebral Block)
Short-term Working Memory and Executive Training

Cognitive remediation (CR) therapies refer to a number of recent developments to use behavioural strategies to improve neurocognitive abilities and improve everyday functioning in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study, we aim to examine whether we can observe CR effects on measures of neuroplasticity, cognition, and functioning when using a rigorous control comparison group. We hypothesize that the active group will exhibit improvements in executive functioning composite scores, improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of a chronic mental disorder (defined herein as bipolar disorder, major depressive disorder, or a schizophrenia-spectrum disorder)
* between the ages of 18 and 65
* speak and read fluent English
* able to use a computer

Exclusion Criteria:

* active substance abuse or dependence diagnosis
* sensory or motor issues that would preclude completion of study procedures
* enrollment in a cognitive remediation program or use of cognitive training programs (e.g. lumosity.com) within the past 6 months
Project CASCADE: Community and Academic Synergy for Cancer Survivorship Care Delivery Enhancement

The purpose of this study is to implement a clinic-level cancer survivorship care delivery intervention in partnership with community health center clinicians, patients, and community representatives to test effectiveness of the intervention to improve patient and clinician outcomes and to evaluate implementation of the intervention using an iterative, concurrent mixed-methods approach guided by the Practice Change Model.


Eligibility Criteria:
Inclusion Criteria (participants):

-at least one visit to the Community Health Centers (CHCs) in the prior year

Exclusion Criteria (participants):

- no history of cancer recorded in the problem list or past medical history in the medical record

Inclusion Criteria (clinicians):

-employed clinicians (e.g. physicians, nurses, pharmacists, or other allied health professionals) and non-clinician staff of the participating CHC clinics
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s

To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects whose age is over 18 years old and under 65 years old
2. Subjects whose WSRS grade is equal or greater than 2
3. Subjects must be willing and able to provide written informed consent form
4. Subjects who are scheduled to be treated with YVOIRE volumes for facial tissue augmentation to correct the nasolabial folds

Exclusion Criteria:

1. Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE volume s
2. Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds
3. Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening
4. Subjects who have received face lifting or plastic surgery on face within 9 months before screening
5. Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening
6. Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites
7. Subjects who tend to have hypertrophic scars
8. Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders.
9. Women in pregnancy or lactation
Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC

This study is conducted to evaluate the efficacy and safety of lenvatinib plus iodine-125 seed brachytherapy (Len-I) compared with lenvatinib (Len) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).

This is a single-center, prospective and randomized controlled trial to evaluate the efficacy and safety of Len-I versus Len alone for patients with TACE-refractory HCC.

187 patients with TACE-refractory HCC will be enrolled in this study. The patients will receive either Len-I or Len alone using an 2:1 randomization scheme.

Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the Len-I arm, iodion-125 seeds will be implanted into the the target lesions (viable intrahepatic tumor and/or vascular tumor thrombus) under CT guidance according to the pre-operative planning within 7 days after lenvatinib administration. Iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

The primary end point of this study is overall survival (OS). The secondary endpoints are progression-free survival (PFS), time to progression (TTP), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* HCC confirmed by histopathology and/or cytology, or diagnosed clinically
* Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
* Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
* At least one measurable intrahepatic target lesion
* Child-Pugh class A/B
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 3 months

Exclusion Criteria:

* Extrahepatic metastasis
* Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
* Vena cava invasion
* Patients who received prior systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy (HAIC) or radiotherapy for HCC
* History of organ and cell transplantation
* History of bleeding from esophagogastric varices
* History of hepatic encephalopathy
* Hematologic examination: platelets \<50×10\^9/L
* Prothrombin time prolongation ≥ 4s
* Severe organ (heart, lung, kidney) dysfunction
* History of malignancy other than HCC
A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma

The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.


Eligibility Criteria:
Inclusion Criteria:

* having histologically confirmed NHL expressing CD20 antigen
* having obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
* signed an informed consent form which was approved by the institutional review board of the respective medical center
* aged from 18 to 75 years
* ECOG performance status of 0 to 1
* expected survival of at least ≥ 3 months

Exclusion Criteria:

* had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
* having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy
* participating in other clinical trial within 30 days before enrolment
* with serious hematologic dysfunction (white blood cell count of \<3.0×103/uL; absolute neutrophil count of \<1.5×103/ uL; platelet count of \< 75×103/uL; hemoglobin level of \< 8.0 g/dL); hepatic dysfunction (total bilirubin level of \> 1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \>2.5 × ULN; renal dysfunction (serum creatinine level of \> 1.5×ULN ); and International normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT) \> 1.5 × ULN (unless on therapeutic coagulation)
* had received live vaccine within 4 weeks prior to study entry
* with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease
* seropositive for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated
* recent major surgery (within 28 days prior to study entry )
* with a history of allergic reaction or protein product allergy including murine proteins
* pregnant or lactating or not accepted birth control methods including male patients
* patients considered unsuitable by PI
* previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer
* active opportunistic infections and other serious non neoplastic diseases
Inferior Vena Cava Index in Patients Undergoing Liver Resection

The aim of this study was to evaluate whether IVC index measured intraoperatively was affected by fluid administration and could add any helpful information about the hemodynamics during hepatic resection. In addition, the investigators evaluated whether IVC index was somehow correlated with the risk of postoperative complication.


Eligibility Criteria:
Inclusion Criteria:

Patients who underwent hepatectomy for primary and secondary liver tumors

Exclusion Criteria:

Patients with tumoral thrombosis or full tumoral involvement/compression of IVC were excluded. Patients unresectable at laparotomy for any extra-hepatic or intrahepatic reason and patients previously submitted to hepatectomy were not included
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.

This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in high-risk patients. The purpose of this study is to determine whether this endovascular prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram, intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1 month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.

Eligibility Criteria:
Inclusion Criteria:

* The aneurysm is \>/= 5 cm or larger, or with a high risk of rupture due to its shape, history of growth, symptoms, or the presence of a large (\>2 cm) iliac aneurysm
* Anticipated mortality greater than 10 percent with conventional surgery
* Life expectancy greater than 2 years
* Suitable arterial anatomy
* Absence of systemic disease or allergy that precludes an endovascular repair
* Capable of giving informed consent and willingness to comply with the follow-up schedule

Exclusion Criteria:

* Pregnancy
* History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
* Allergy to stainless steel or polyester
* Unwilling to comply with the follow-up schedule
* Serious or systemic groin infection
* Coagulopathy, other than coumadin therapy
* Inability to give informed consent
Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients

Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who are 18\~70 years of age on the day of signing informed consent,
* Have a diagnosis of RA meeting the 1987 ACR/EULAR criteria of RA and ACR functional class I-III,
* Body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 30,
* Have agreed to not use any anti- rheumatic drug except for study drugs during the study period.

Exclusion Criteria:

* Current therapy with any disease modifying anti-rheumatic drug (DMARD), with the exception of Methotrexate (MTX), Leflunomide, sulfasalazine, antimalarials, gold preparations, penicillamine, which must have discontinued for a period of at least 7 t1/2s prior to dosing,
* Previous RA treatment with DMARDs or drugs with strong immunosuppressive effect in 3 months prior to dosing (12 months for rituximab or other B cell depleting agents),
* Previous therapy with NSAIDs or oral glucocorticoids in 2 weeks before dosing,
* Any parenteral (intramuscular or intravenous injection) or intra-articular corticosteroids therapy in 4 weeks before dosing,
* Previous treatment with interferons in 4 weeks before dosing.
Intradural Disc Herniation: a Case Report and Review of Complications

This observational study collects clinical data as well as pathological reports from a patient with an intradural disc herniation, reports on the course of the patient's recovery through surgical treatment, summarizes the complications of this type of disease, and provides new ideas for improving the chances of preoperative diagnosis.

We collect the patient's personal history, family history, reason for visit, visit flow, clinical data, pathology reports, and surgical images and videos.

Eligibility Criteria:
Inclusion Criteria:

* IDH patients

Exclusion Criteria:

* no