cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo

* Study in proof of concept;
* Double blind study;
* Comparative study, versus placebo in intra-individual
* Three parallel groups testing different dosages / combinations of treatments
* Randomized.

This study has as objectives:

Primary objective :

• Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;

Secondary objectives:

Evaluate:

* the percentage of repigmentation observed after one, two and three months of treatment measured on an objective layer by image analysis;
* the ability of the product to maintain the human body in good condition (cutaneous acceptability) by clinical examination by the dermatologist;
* Patient satisfaction using a visual analogue scale from 0 to 10.
* The illustrative effect using standardized photographs;
* The quantity of product by weighing the tubes.
* The occurrence of possible adverse effects.

Population:

* Sexe: female and male;
* Age: over 18 years old;
* Patients with stable non-segmental vitiligo lesions (defined as no new lesions or lesions that have been present for at least 3 months, lack of hypochromic margins in Wood's lumen and absence of confetti depigmentation);
* Patients with 2 to 6 symmetrical lesions (1 to 3 on each side). These lesions (macules) will be treated for a minimum surface of 2 cm² and a maximum surface of 100 cm².

Eligibility Criteria:
•Inclusion Criteria: Sexe: female and male;

* Age: over 18 years old;
* Patients with stable non-segmental vitiligo lesions (defined as no new lesions or lesions that have been present for at least 3 months, lack of hypochromic margins in Wood's lumen and absence of confetti depigmentation);
* Patients with 2 to 6 symmetrical lesions (1 to 3 on each side). These lesions (macules) will be treated for a minimum surface of 2 cm² and a maximum surface of 100 cm².
* Healthy volunteer;
* Volunteer having given in writing his free, informed and express consent;
* Volunteer willing to abide by the protocol and procedures of the study.

Exclusion Criteria:

* Pregnant woman or woman who is breastfeeding or planning for early pregnancy during the study;
* Patient with segmental or mixed vitiligo;
* Patient with vitiligo of the external genitalia;
* Patient with vitiligo touching hands and feet only
* Patient with a history of skin cancer or pre-cancerous skin lesions;
* Patient taking topical or systemic vitiligo treatments in the month prior to the start of the study;
* Patient taking concomitant local or general corticosteroid therapy or immunomodulatory therapy;
* Patient with a history of photodermatoses or taking photosensitizing medications;
* Patient having planned to expose himself (artificial sun or UV) during the study at the level of the zones to be treated and / or having been exposed during the month preceding the beginning of the study and having an acquired pigmentation (tanning) obvious;
* Patient who had been treated with phototherapy within 4 weeks before randomization;
* Patient with lithium allergy.
The Interaction Between Oxytocin and Serotonin

The primary objective of this study is to identify any interaction between oxytocin and serotonin on neural and behavioral activity related to social reward and decision making by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design

Serotonin and oxytocin have been proved to play an important role in social reward processing and decision making in human. The aim of this study is to determine whether they interact in those essential human behaviors by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design, in which 4 groups of healthy males will be administered with a random combination of nasal oxytocin (24 international units, IU) or placebo and acute tryptophan depletion (ATD, 75.2g) or placebo (a tryptophan-balanced mixture, 78.2g). The social-reward related neural activity and behavior will be assessed by a series of social reward task in and out of fMRI scanner and the decision making will be assessed by reversal learning task, ultimatum game (UG) and loss aversion task. The interaction between serotonin and oxytocin on brain networks will also be tested by resting state.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders
* Right-handedness

Exclusion Criteria:

* History of head injury;
* Medical or psychiatric illness.
* High blood pressure, general cardio-vascular alterations
* History of drug or alcohol abuse or addiction.
* Allergy against medications or general strong allergies
* Sleep disorders.
* Visual or motor impairments
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics

This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.

This is a Phase 1, single center, single-ascending dose, sequential, randomized, and crossover study.

Following a Screening period of up to 21 days, eligible subjects will be randomized different dosing sequences, with approximately 4 subjects allocated to each dosing sequence. The total in-clinic duration for each subject will be 24 days (including the admission day prior to the first dosing period).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.

Exclusion Criteria:

Clinically significant history of unstable medical abnormality. Inability to cooperate with study procedures. Female subjects with a positive pregnancy test result, nursing or lactating. Participation in any other investigational drug trial within 90 days prior to screening. A history of prescription drug abuse, or illicit drug or known drug dependence within last 5 years prior to screening. Use of any prescription medication within 14 days prior to dosing. A history of alcohol abuse or dependence.
Mean Systemic Filling Pressure Trends in Liver Transplant Recipients

Patients with end stage liver disease undergoing liver transplantation have varying degrees of intraoperative haemodynamic unstability during various phases of transplantation. It is difficult to determine the cause for hemodynamic instability in these patients and to predict the best treatments. Currently, cardiovascular resuscitation options are triggered by arterial pressure and cardiac output (CO) measures, focusing on the oxygen delivery side of the circulation. The primary determinants of cardiac output reside on the venous side. Veins are 30-50 times more compliant than arteries and contain approximately 75% of the total blood volume. Mean systemic filling pressure provides vital information on this venous side of the circulation. Mean systemic filling pressure , which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. We would study the Mean systemic filling pressure in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 7 days for respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between Mean systemic filling pressure and these outcomes will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing liver transplantation 18-65 years

Exclusion Criteria:

* pregnant patients acute liver failure, acute on chronic liver failure
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates

This research aims to identify which behavioral science strategies are most effective at increasing flu vaccination rates overall and based on patients' individual characteristics. Past behavioral science interventions have shown promise in increasing flu vaccinations. For example, successful interventions have encouraged people to make concrete plans for when they will get a flu vaccination (Milkman et al. 2011), sent automated calls or text messages reminding patients to get a flu vaccination (Cutrona et al. 2018; Regan et al. 2017), or provided financial incentives for getting vaccinated (Nowalk et al. 2010). Although these results are promising, these studies have been conducted in isolation on different populations, which makes it difficult to compare their interventions' effectiveness or to have enough power to reliably detect differing responses to interventions based on individual characteristics.

This research will simultaneously test 19 different SMS interventions to increase flu vaccinations in a "mega-study" and apply machine learning to identify which interventions work best for whom. The interventions are designed by behavioral science experts from the Behavior Change for Good Initiative (BCFG), Penn Medicine Nudge Unit (PMNU), and Geisinger Behavioral Insights Team (BIT). We expect to include at least 80,000 participants.

The specific aims of this research are to identify (1) which behavioral science strategies effectively increase flu vaccination rates overall, and (2) which strategies are most effective for different subgroups (e.g., based on age, gender, race).


Eligibility Criteria:
Penn Medicine and Geisinger patients will be included if they:

Inclusion Criteria:

* Have a cell phone number recorded in a Penn Medicine or Geisinger database
* Have a new or routine primary care appointment during the study recruitment period (not a sick visit)

Exclusion Criteria:

* Have documentation of allergy or adverse event to influenza vaccination in medical records
* Have documentation of already receiving their 2020 influenza vaccination prior to randomization in medical records
* Have opted out of receiving text message appointment reminders
* Have asked not to be contacted for research purposes
* Have an appointment with someone other than their primary care physician
* Have an appointment with someone other than a physician, resident, nurse practitioner, or physician assistant

We will recruit as many patients as possible starting in September 2020. We will stop enrolling participants with appointments scheduled to occur after December 31, 2020 if we have reached 4,000 participants per condition. If we do not have 4,000 participants per condition by December 31, 2020, we will continue enrolling participants until we have reached 4,000 per condition, or until March 31, 2021 (discontinuing enrollment at whichever milestone arrives sooner - 4,000 people enrolled or 3/31/21).
Nutrient Levels Alter Transplant Outcome

The purpose of this study is to look at lipid profiles of plasma and RBC and amino acid profiles in plasma to determine if they are associated with allograft rejection, calcineurin inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving dietary supplements with arginine and omega-3 fatty acids.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipient
* Appropriate blood samples drawn and analyzed
Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief

Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV) lidocaine infusion for postoperative pain control after cesarean section.

Study design: prospective randomized, double-blind, placebo-controlled study. Patients and methods: Initially, 165 pregnant full-term females, indicated to be underwent elective cesarean delivery for various indications were randomized equally to either group C (control, IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV (intravenous lidocaine infusion).Five patients were excluded from each group for various reasons. The outcome measures were postoperative pain scoring, total pethidine consumption and the need for postoperative analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy, more than or equal completed 37 gestational weeks, indicated to undergo elective cesarean delivery for various indications

Exclusion Criteria:

* extreme of age (below 18 or above 40 year), uncooperative patients, women under spinal anesthesia, previous abdominal scars, including previous cesarean or myomectomy, multiple gestation, BMI \>35 kg/m², chorioamnionitis, hypersensitivity or contraindications to lidocaine, bronchial asthma, bleeding diathesis, pregnancy induced-hypertension, liver or kidney diseases, diabetes mellitus, and patients with psychological disturbance, or any form of chronic pain before or during pregnancy.
A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients with malignant bone disease;
* patients with moderate to severe pain.

Exclusion Criteria:

* patients who have received a bisphosphonate within 3 weeks from the signing of the informed consent;
* patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
* untreated esophagitis or gastric ulcers;
* recent or pre-scheduled radiotherapy to bone;
* patients who are pregnant or breast-feeding.
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women 45 years or older. No period for at least two years.
* History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator).
* Minimum of one moderate spinal bone fracture.
* Beginning pain level of at least four on an eleven point scale.
* Bone Mineral Density (BMD) must meet criteria
* Able to read, understand, and administer self-questionnaires.
* Be willing and able to use a pen-injector to deliver the medication.

Exclusion Criteria:

* Are at increased risk for osteosarcoma.
* Have an active or suspected diseases that affects bone metabolism other than osteoporosis.
* Participants that already know that they will require procedures to repair their spinal bone fractures.
* Abnormal values of certain lab tests.
* Anything that would make it difficult to determine if the back pain was due to the fracture.
* Poor medical or psychiatric condition.
* Alcohol or drug abuse within a year of the study start.
* Certain malignant neoplasms in the 5 years prior to enrollment.
* Active liver disease or clinical jaundice.
* Significantly impaired renal function.
* History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.
* Known contraindication or intolerance to risedronate and/or teriparatide therapy.
* Treatment with oral strontium or certain therapeutic doses of fluoride.
Targeting CD19/CD20/CD22 Triple-targeted Cell in Patients With Relapsed/Refractory B-cell Lymphoma

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation targeting CD19/CD20/CD22, in patients with relapsed/refractory B-cell lymphoma.

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LCAR-AIO in the patient ≥ 18 years of age with relapsed or refractory B cell lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LCAR-AIO injection. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment, and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell lymphoma that expresses at least one of CD19/CD20/CD22.
5. At least one measurable tumor lesion determined according to Lugano 2014 criteria.
6. Response to prior therapy is consistent with one of the following:

   1. Primary refractory: it means that the best response to first-line therapy (at least 2 cycles) is PD, or best response to first-line therapy (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;
   2. Relapsed or refractory after 2 or more lines of therapy. Refractory is defined that best respond to the most recent treatment regimen (at least 2 cycles) is PD, or best response to the most recent treatment regimen (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;
   3. Progression or relapse within 12 months after hematopoietic stem cell transplantation; if salvage therapy is applied after transplantation, the patient must be unresponsive or relapsed to the last line of therapy;
7. Life expectancy≥ 3 months
8. Clinical laboratory values meet screening visit criteria
9. Adequate organ function;

Exclusion Criteria:

Subject eligible for this study must not meet any of the following criteria:

1. Prior antitumor therapy with insufficient washout period ;
2. Patients who received dual-targeted CAR-T cell therapy (including but not limited to sequential infusion) at any time in the past, or who received CAR-T cell therapy of cameloid origin;
3. With acute or chronic graft-versus-host disease (GvHD);
4. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
5. Known life-threatening allergies, hypersensitivity, or intolerance to LCAR-AIO CAR-T cell or its excipients, including DMSO (refer to Investigator's Brochure).
6. Pregnant or lactating women;
Improvement and Application of New Closed Drainage Device

According to the problems of traditional closed thoracic drainage in clinical work, this study aims to further improve and improve the new closed thoracic drainage system by changing the material of drainage tube, increasing the regulating valve of external fixator and increasing the gas flow monitoring kit for special patients, so as to expand its clinical application scope and formulate its operation. Standardize. At the same time, through a randomized controlled study, the simplicity, effectiveness and safety of the new minimally invasive thoracic closed drainage system developed by the research group were deeply studied.

The traditional closed thoracic drainage method has complex operation and high technical requirements. It has obvious pain during and after operation. Operational complications such as tissue organs, intercostal vessels and nerve injury may occur during the operation. Accidents may also occur after catheterization, including leakage around thoracic drainage tube, thoracic drainage tube prolapse, subcutaneous emphysema and accumulation. Liquid; To solve these problems, we have invented "minimally invasive thoracic closed drainage system" through a number of patent designs, including: thoracic closed drainage tube implantation expansion forceps, double-chamber thoracic drainage device with side balloon, guide wire, puncture needle, various types of dilators, chest tube fixation devices, etc. The system has the characteristics of minimally invasive puncture and implantation of drainage tube, safe, fast operation, no need of suture and fixation, good position of drainage tube after implantation, less pain for patients, and closing incision in the medial part of patients, avoiding leakage and subcutaneous emphysema and hydrops.

Eligibility Criteria:
The selection criteria were as follows:

* age 18-70 years, gender is not limited;
* subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study and sign the informed consent;
* 18 Kg/m2 \< BMI \< 25 Kg/m2;
* patients who need thoracic closed drainage for exhaust and drainage because of pneumothorax volume \> 30%;
* subjects did not have serious chest wall deformities.

Exclusion criteria:

* Patients at high risk of bleeding, including patients with congenital hemophilia, thrombocytopenia (PLT \< 50 \*109/L), platelet dysfunction (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet dysfunction);
* Cardiopulmonary function is poor, which is not suitable for the participants.
* Patients with other infectious diseases (inflammation, tuberculosis) or empyema in the thoracic cavity;
* Infection of skin around puncture and drainage;
* Participated in other clinical trials within 30 days;
* Other reasons why the researchers think it is inappropriate to participate in the experiment.
Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

The purpose of this study is to help us learn what is the best amount of fluid to administer to patients during liver surgery. Patients will receive either an amount for this surgery based on weight, blood pressure, heart rate and urine output or an amount guided by a computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on real time information like blood pressure, pulse and the ability of the heart and blood vessels to maintain normal vital signs.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years old or greater) who are able to provide informed consent.
* Patients who undergo an open, elective liver resection. Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.

Exclusion Criteria:

* Active coronary disease.
* Patients with a history of coronary disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 3 months of operation.
* Active symptomatic cerebrovascular disease.
* Active congestive heart failure and ejection fraction \<35%.
* Active severe restrictive or obstructive pulmonary disease and resting SpO2 \<90%.
* Active renal dysfunction (Cr \>1.8)
* Abnormal coagulation parameters (INR \> 1.8 not on Coumadin, or platelet count \< 100,000 per mcL)
* Presence of active infection including HIV
* Patients with active atrial fibrillation or flutter.
* Preoperative hypoalbuminemia (Albumin \< 2g/dl).
* Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery).
* Presence of ascites.
* BMI \> 45 or \<17