cyrilzakka/clinical-trials huggingface dataset:
Quadratus Lumborum Versus Placebo in Open Ventral Hernia Repair

The purpose of this study is to determine whether using a QL block is better than placebo (a look-alike substance that contains no drug) in lowering the amount of opioids you need for pain relief in the first 24 hours and if it improves your recovery following a ventral hernia repair.

Participants will be asked to complete a questionnaire before surgery and again at their 30-day follow up. You will also be asked to complete a pain diary 24 hours after surgery and attend a follow-up visit approximately 30 days after surgery.

The following information will be collected from you or your medical record:

1. Pain medications given to you during surgery.
2. Pain medications prescribed to you after surgery, including medication name, dose, units, and frequency.
3. Pain levels during the first 24 hours after surgery.
4. Your total hospital length of stay after surgery.
5. Any complications that you may have experienced after surgery.
6. Demographic information, medical history as well as details about your hernia repair surgery.

Quadratus Lumborum (QL) blocks have provided analgesia for abdominal surgery. These blocks involve ultrasound-guided local anesthetic injection deep into the anterior fascia of the quadratus lumborum into the thoracolumbar fascia, resulting in widespread abdominal and pelvic pain control. QL blocks extend that coverage from T4 to L1 in the paravertebral space. At this local institution, QL blocks have demonstrated the ability to provide complete sensory analgesia for most patients from T9-L1 up to an estimated 17 hours after surgery. Therefore the goal of this study is to evaluate the effectiveness of QL block in this patient population.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Able to read and understand study procedures
3. Willing to participate and sign an informed consent form
4. Open approaches to ventral hernia repair
5. Clean (CDC Class I), clean-contaminated (CDC Class II)
6. Elective surgery
7. Mesh placed in the retromuscular position

Exclusion Criteria:

1. Dirty-Infected cases (CDC Class IV): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
2. Patient has a contraindication to receiving the drug and/or procedure: allergy/sensitivity to the drug, coagulopathy, abdominal wall infection at the drug administration site, systemic infection, anatomical distortion, neuropathy
3. Emergent procedure
4. Mesh not placed
MRI Analysis and Degenerative Spine

Analysis of MRI advanced techniques in degenerative spinal disease.

The main questions it aims to answer are:

* Can we assess microstructural integrity of compressed nerve roots in degenerative spinal disease
* What are the image biomarkers affected by disease
* How they evolve with disease progression and treatment


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 85 years
* Diagnosis of spinal disease by clinical and imagiological criteria
* More than 3 months duration of disease
* Ability to give consent
* Fluent portuguese speaker

Exclusion Criteria:

* Previous spine surgery
* Spinal instability
* Neurological disease that might interfere with walking
* Known orthopedic conditions that causes significant gait impairment
* Dementia or development disorder with cognitive impairment
* Inability to give consent
Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest

Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Several studies have already shown that early interventions performed after ROSC, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. However, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. Consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. Overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. Indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.


Eligibility Criteria:
Inclusion Criteria:

* all adult patients, major, admitted to intensive care after cardiac arrest (after both in and out-of hospital cardiac arrest),
* comatose (defined by Glasgow score ≤ 8) on admission,

Exclusion Criteria:

* cardiac arrest occurring intra-hospital,
* minor patient,
* major patient under guardianship,
* protected persons,
* prior inclusion in the study
Aprepitant for Post-operative Nausea

Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy patients.
* Must be able to swallow a pill.

Exclusion Criteria:

* Liver failure,
* Age less than 18.
* Pregnancy, breast-feeding.
* Pre-op vomiting.
* Allergy to aprepitant.
* Need for post-op gastric drainage.
* Use of drugs that interact with aprepitant.
Evaluation of Patients With Blood Disorders

The Hematology Service provides hematology consultations for patients at the Clinical Center and participates in the training of hematology fellows. Patients with a broad range of hematologic disorders must be available in order for the senior staff of the Service to maintain clinical expertise and to provide the breadth of experience necessary for the fellowship program. The purpose of this protocol is to meet these needs by allowing the Hematology Service to see patients with a spectrum of hematologic diseases not studied on existing research protocols at the NIH. These patients will be evaluated over the course of several outpatient visits and returned to the care of their referring physicians.This study was developed to evaluate and possibly treat patients with blood disorders. The Hematology Service of the National Institutes of Health is responsible for the care of patients participating in research studies. In addition the Hematology Service also provides consultation for small groups of patients with blood disorders that have not been diagnosed or that may need special testing.

This study will also provide doctors at the NIH the opportunity to learn more about a wide range of blood disorders and conditions. Patients participating in this study will be evaluated over the course of several outpatient visits and will continue to be cared for by their regular physician.

The Hematology Service provides hematology consultations for patients at the Clinical Center and participates in the training of hematology fellows. Patients with a broad range of hematologic disorders must be available in order for the senior staff of the Service to maintain clinical expertise and to provide the breadth of experience necessary for the fellowship program. The purpose of this protocol is to meet these needs by allowing the Hematology Service to see patients with a spectrum of hematologic diseases not studied on existing research protocols at the NIH. These patients will be evaluated over the course of several outpatient visits and returned to the care of their referring physicians.

Eligibility Criteria:
* INCLUSION CRITERIA:

The patient must have or be suspected of having a blood disorder.

The patient must be clinically stable enough for outpatient evaluation.

The patients must be referred from a physician outside the NIH who will continue to provide the patient's primary medical care.

EXCLUSION CRITERIA:

Inability of patient, parent or legal gaurdian to provide informed consent.
Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement

Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement

The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, or III
* Planning to undergo primary unilateral Total Knee Arthroplasty (TKA)

Key Exclusion Criteria:

* A body mass index (BMI) greater than 43
* Known bleeding disorder or is taking agents affecting coagulation preoperatively
* Use of medications or a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments
* Diabetes mellitus with a known HbA1C\>9.5 or a history of prolonged uncontrolled diabetes
* Previous knee arthroplasty (partial or total) of the same knee
* Participated in another clinical trial within 30 days prior to the planned TKA surgery
The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser

The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-60 years old, regardless of gender;
2. Clinical diagnosis of atrophic acne scars;
3. Planning to undergo ultra-pulsed CO2 lattice laser therapy;
4. The patient agrees to participate in this experiment and signs an informed consent form

Exclusion Criteria:

1. Those who take sedative drugs for a long time;
2. Patients with sleep apnea syndrome, previous history of hypertension, and blood pressure greater than 160/100mmHg
3. People with severe heart and lung diseases, liver and kidney diseases, psychosis, pregnancy, and communication disorders;
4. Persons who are known to be allergic to the main drug or any of the excipients in Dezocine injection;
5. Increased intracranial pressure or head injury;
6. Acute and chronic alcoholism;
7. People with hypotension, hypothyroidism, acute episodes of asthma, and epilepsy

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Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer

The primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.

Laparoscopic surgery represents a milestone for treatment of gastric and rectal cancer, with advantages of minimal invasion and rapid recovery compared to open approach. However, for progressive gastric and rectal cancer, laparoscopic approach has not been officially promoted by NCCN guideline (2015).

Over the past decade, circulating tumor cells (CTCs), originated from a tumor cell, have been identified as potential blood-based biomarkers capable of providing prognostic and predictive Information.

In the present study, the investigators utilize the CTCBIOPSY® system (YZYBIO Company, Wuhan, China), which has been approved by CFDA (Chinese Food and Drug Administration), to detect CTCs, and try to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.

Eligibility Criteria:
Gastric cancer

Inclusion Criteria:

* Gastric cancer of stage II/III

Exclusion Criteria:

* History of malignant tumors
* Gastric cancer of stage Ⅳ
* Preoperative neoadjuvant chemotherapy
* History of upper abdominal surgery
* Severe other contradictions of surgery

Rectal cancer

Inclusion Criteria:

* Primary rectal carcinoma
* Single lesion
* No metastasis
* Sphincter-saving surgery available

Exclusion Criteria:

* History of malignant tumors
* Acute bowel obstruction, bleeding or perforation
* Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
* Severe other contradictions of surgery
Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer

The investigators hypothesize that the implementation of a Web-application in patients initiating adjuvant hormone therapy for breast cancer brings a benefit on treatment adherence and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years old
* Breast cancer patient candidate for adjuvant hormone therapy
* Mastery of the French language
* Patient with a cell phone and an Internet connection
* Patient able to use a computer, smartphone, or tablet.
* Patient affiliated to a social security system
* Signing of informed consent prior to any specific study-related procedure

Exclusion Criteria:

* Patient who has previously received hormone therapy for cancer.
* Patient not trained in the use of the application
* Any associated medical or psychiatric condition that might compromise the patient's ability to participate in the study
* Patients with locoregional or metastatic recurrence
* Other history of cancer.
* Patient deprived of liberty, under guardianship or curatorship
* Simultaneous participation in a therapeutic clinical trial or other clinical study involving a connected tool
* Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons
Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of multiple intravenous (IV) doses of ravulizumab administered to complement inhibitor treatment-naïve participants with PNH.

The study consisted of a screening period of up to 30 days and a Treatment Period of up to 253 days for Cohorts 1-3 and 281 days for Cohort 4. After completion of the Treatment Period, all participants had the opportunity to enter the Extension Period, wherein participants continue to receive ravulizumab for up to 5 years. The first dose in the Extension Period occurred on Day 253 for Cohorts 1-3 and on Day 281 for Cohort 4.

The data presented includes the Primary Completion date of the study for the Treatment Period. The results for the Extension Period will be reported after study completion.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age
2. PNH diagnosis confirmed by documented high-sensitivity flow cytometry
3. Documented meningococcal vaccination not more than 3 years prior to dosing
4. Female participants of childbearing potential were to use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
5. Willing and able to give written informed consent and comply with the study visit schedule

Exclusion Criteria:

1. Treatment with a complement inhibitor at any time
2. Female participants who are planning to become pregnant, or are pregnant, breastfeeding or who had a positive pregnancy test at screening or Day 1
3. Participation in an interventional clinical study within 30 days before initiation of dosing on Day 1, or use of any experimental therapy within 30 days prior to dosing on Day 1, or within 5 half-lives of the investigational product, whichever was greater
4. History of allergy to any drug, allergen, excipients of ravulizumab or known allergy to Chinese hamster ovary cell proteins
5. Inability to comply with study requirements
6. History of any clinically significant cardiac, hepatic, immunologic, pulmonary, or rheumatoid disease that, in the Investigator's judgment, would preclude participation
7. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrollment
Determining the Microbiota Composition of the Middle Meatus in Parkinson's

The exact cause of PD remains unknown, but current theories suggest that it results from a combination of hereditary or genetic factors (i.e. family traits ) and exposure to unknown substances in the environment. The purpose of this study is to investigate whether toxins produced by bacteria that live within the nasal canal (nose) and the intestines of people with PD might have a role in causing the disease. The investigators in this study would like to look at the types of bacteria that live in the nasal canals and intestines of PD subjects and compare them with those of subjects who do not have PD.


Eligibility Criteria:
Inclusion Criteria:

- 1. Patients with a clinical diagnosis of Parkinson's disease by United Kingdom Parkinson Disease Society Brain Bank criteria will be recruited.

2. Hoehn \& Yahr stage 1-3 3. Parkinson's disease symptomatic treatment will be allowed. 4. Subjects with deep brain stimulation are allowed.

Exclusion Criteria:

* 1. Occupation expected to change intestinal flora pattern (e.g. sanitation worker) 2. Treatment with medications that may induce parkinsonism (metoclopramide, typical, or atypical antipsychotic agents) 3. Treatment within 12 weeks with systemic antibiotics 4. Known diagnosis of inflammatory bowel disease 5. Symptomatic organic GI disease other than hemorrhoids and hiatal hernia or abdominal surgeries for symptomatic GI disease such as bowel resection, diverticular surgery, colostomy, etc (subjects with a history of an appendectomy or cholesytectomy for benign disease more than 5 years prior to presentation are allowed).

  6. Symptomatic functional GI disease that significantly impairs intestinal motility such as scleroderma or use of GI motility drugs 7. Acute illness requiring immediate hospitalization 8. Pre-existent organ failure or comorbidities as these may change GI flora:
  1. Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X\> normal);
  2. Kidney disease (creatinine\>2.0 mg/dL);
  3. Uncontrolled psychiatric illness;
  4. Clinically important lung disease or heart failure;
  5. HIV disease;
  6. Alcoholism, unreliable drinking history; or consumption of alcohol more than 3 times a week or binge drinking or drinking more than or equal to 3 drinks per occasion;
  7. Transplant recipients;
  8. Diabetes;
  9. Clinically significant dehydration or clinically detectable ascites or peripheral edema or cardiac failure 9. Presence of short bowel syndrome or severe malnutrition with ideal body weight \< or = 90% or 10. Estimated survival \<1 year and Karnofsky performance status \<50%; 11. Use of immunosuppressive medications within 3 months of enrollment 12. Chronic use of diuretics
CLUSTER Trial for Outbreak Detection and Response

Despite the critical importance of identifying hospital-associated outbreaks as early as possible in order to limit their spread, there are currently no standardized methods for cluster detection. The CLUSTER Trial (Cluster Linkage Using Statistics to Trigger and Evaluate Response) will assess whether a statistically-based automated cluster detection method coupled with a robust response protocol will enable rapid containment of hospital clusters as measured by a reduction in cluster size and duration as compared to routine hospital cluster detection methods coupled with the same response protocol.

Note: that enrolled "subjects" represents 82 individual HCA Healthcare hospitals that have been randomized


Eligibility Criteria:
Facility Inclusion Criteria:

* All U.S. HCA Healthcare hospitals that provide inpatient care.
* Facilities that are reporting to the centralized data warehouse during the study period.

Facility Exclusion Criteria:

-

Note: unit of randomization is the hospital.
Eyelash Growth From Application of Bimatoprost in Gel Suspension to the Base of the Eyelashes

Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled. Each participant received two vials of gel suspension, which contained bimatoprost and normal saline, respectively, each mixed 1:1 with GonakTM gel and labeled "right eye" and "left eye" according to randomization. The suspension was applied to the eyelashes every evening on the designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly intervals during the study and at 1 and 3 months after study completion. Visual acuity, ocular symptoms, intraocular pressure and photographs were documented at these same intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control average of 1.13mm) which was a statistically significant difference (p=0.009). The average intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity or iris discoloration was noted in any of the subjects. Discussion: Our data showed an increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have eyelash lengthening properties.

Study completed

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 20 and less than 90 and patients who have previously used and are comfortable with applying mascara.

Exclusion Criteria:

* History of glaucoma, uveitis, pregnancy, allergic reaction to prostaglandins or the gel suspension, alopecia, and previous usage of other eyelash growth enhancement.
Comparison of Two ECG Guided PICC Insertion Techniques

The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.

One technique uses ECG signal transmission with saline water and allows external catheter length adjustment while the other technique uses a guidewire for signal transmission thus requiring prior catheter length adjustment

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Adult \> 18 years
* Referred to the interventional radiology department for PICC insertion

Exclusion Criteria:

* Known or suspected non-compliance
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Impairment of the heart rhythm changing the presentation of the P wave (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm)
* Enrolled in conflicting research study
* Weight\> 150 kg, technical limit for the fluoroscopy table
* Impossibility of obtaining informed consent
* Refusal to be informed in the event of a chance discovery