cyrilzakka/clinical-trials huggingface dataset:
A Herbal Compound for Psoriasis

The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:

• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.

Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of the disease by a doctor
* Age range between 18 and 60 years
* Both sexes (male and female)
* Having written informed consent to participate in the study
* Lack of allergy to food and health products
* Only local tissue involvement and no need to take oral medications
* Absence of underlying diseases and immune deficiency
* Absence of pregnancy and breastfeeding
* Absence of blisters and infection caused by the disease

Exclusion Criteria:

* Non-consent of the doctor directly responsible for the patient
* Incidence of drug product allergy
* Occurrence of symptoms of skin, digestive, liver or kidney diseases
* Patient\&#39;s lack of consent to continue for any reason
Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

A prospective, single center, open-label, randomized trial of Thymoglobulin induction and sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased donor kidney transplant recipients.

Calcineurin inhibitor-associated nephrotoxicity may exacerbate chronic allograft nephropathy and reduce long-term kidney graft survival. Complete avoidance of calcineurin inhibitors may improve graft function as measured by serum creatinine and calculated GFR and improve long-term outcomes following kidney transplantation. We conducted a prospective, randomized, single-center study comparing sirolimus versus tacrolimus in kidney transplantation. Primary cadaver of non-HLA identical living donor recipients are randomized to received either sirolimus 5 mg QD (target level 8-12 ng/ml) or tacrolimus 0.075 mg/kg BID (target level 8-12 ng/ml). All patients also received Thymoglobulin 1.5 mg/kg x 4 doses, mycophenolate 1 gm BID, and prednisone. Main outcome measures are patient and graft survival, biopsy-proven acute rejection, serum creatinine, hyperlipidemia, post-transplant diabetes, and surgical and wound complications.

Eligibility Criteria:
Inclusion Criteria:

Primary cadaver or non-HLA identical living donor kidney transplant. -

Exclusion Criteria:

HIV HCV Pregnancy Age \< 18 years Malignancy

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A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of PCUR-101 in combination with androgen suppression therapy in the patients with metastatic CRPC


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of metastatic CRPC
* standard of care androgen deprivation treatment
* castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)
* progressive disease while receiving androgen deprivation therapy
* previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria
* adequate hematologic, renal and hepatic function
* KPS of ≥ 70 or ECOG of 0 to 1

Exclusion Criteria:

* pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
* use of opiate analgesics for prostate cancer pain within 4 week of treatment start
* more than one sequential second generation AR-directed therapy
* received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks
* history of bleeding disorder
* history of seizure disorder
* concomitant use of therapeutic anticoagulation
* history of or current cardiac issues
* received external beam radiation therapy within 4 weeks
* CTCAE Grade \> 2 neuropathy
Impact of External Factors(Brexit and Covid-19) on Retention and Turnover in the NHS

Problems with retention and staff turnover in the health sectors of many western countries have a long history and have thus attracted research attention over the years. The National Health Service (NHS) in the United Kingdom (UK) is not immune to this problem as it is reported that the NHS as an organisation is struggling to meet staffing demands particularly with its nursing and medical workforce. One of the ways to tackle this problem has been to recruit staffs from European union countries. With the exit of UK from the EU, there are concerns on the this departure on staffing. While the UK was still coming to terms with BREXIT and its effect on the NHS, the current COVID 19 pandemic struck and has intensified workload and demands on the health sector, particularly the NHS. As a result of this, many NHS employees believe more should be done to show they are valued and appreciated for all their hard work. Turnover is already high among clinical occupations in the NHS as people leave for various reasons. It is therefore important to study the combined effect of these external factors (BREXIT and COVID 19) on turnover and retention in the NHS Grampian. It is hoped that this study will be beneficial to NHS Grampian management and policy makers as it will aid early identification of intention to leave and possibly enhance staff retention. The study will be carried out in Scotland and will be limited to NHS Grampian. Nurses and consultants who have been in employed in NHS Grampian prior to BREXIT and COVID 19 will be invited participate. Participants will voluntarily take part in a semi structured interview which may last for about 45 to 60 minutes. The project is self-funded for the award of a PhD in management studies.


Eligibility Criteria:
Inclusion Criteria:

* Must be employed in NHS Grampian prior to January 2020.
* Must be a Nurse or Consultant

Exclusion Criteria:

* Limited to Nurses and Consultants.
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.

An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Age 19\~45 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
4. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator
Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia

The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled Analgesia (PCA) after open colorectal surgery.

Dexmedetomidine is a selective alpha-2 adrenoceptor agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing effects. Besides, Dexmedetomidine has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. Many studies had been conducted to reduce the side effect of opioid analgesic. The current trend of reducing opioid analgesic side effect is direct combination of other drugs in PCA. The advantages of this method are convenient in clinical use and preventive for side effects.

In this study, 50 patients who is undergoing elective colorectal surgery will be randomly allocated into two groups (Control group and Dexmedetomidine group). Patients in both groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit (PACU) after surgery.

The PCA protocol of Control group is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min. The PCA protocol of Dexmedetomidine group is dezocine 0.6mg/kg, flubiprofen 3mg/k and dexmedetomidine 6μg/kg diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing open colorectal surgery
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18～30kg/m2

Exclusion Criteria:

1. Mental illness or cannot communicate.;
2. A second operation during the study;
3. Slow-type arrhythmias or hypotension;
4. Lung infection or sleep apnea syndrome;
5. Renal failure;
6. Alcohol or drug abuse;
7. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
8. Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history;
Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (POLAR)

Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.

This investigation is planned to investigate the performance and clinical benefits of features that are new to the CP 1170 Sound Processor. This study will build on the evidence previously collected on OTE (off the ear) sound processors and ForwardFocus, with particular focus on the acceptance and satisfaction of the automation of ForwardFocus in the CP1170 Sound Processor and associated components in general.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older
2. Post lingually deafened
3. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522); Freedom Series (CI24RE(CA), CI24RE(ST), CI422) or N24 Series (CIC3).
4. At least 6 months experience with a cochlear hearing implant
5. At least 3 months experience with any Nucleus sound processor and SCAN program
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
7. Willingness to participate in and to comply with all requirements of the protocol
8. Fluent speaker in English as determined by the investigator
9. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Additional disabilities that would prevent participation in evaluations
2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures
3. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation, as determined by the Investigator.
6. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Evaluation of Efficacy and Accuracy of a Cordless Ultrasonic Dissection System

The purpose of this study is to test the efficacy of a new cordless ultrasonic dissection system.

The Sonicision device offers the ability to achieve hemostasis and vessel dissection with a cordless system. The ultrasonic device yields coagulation and transection of vessels by conversion of electrical energy into ultrasonic vibration through a piezoelectric or magnetic transducer, which is the causation of heat induction at the jaws of the instrument through friction. The Sonicision device is able to seal vessels up to 5 mm and transection division of 10 cm segments. The Sonicision device features the following:

1. Cordless design to improve freedom and movement;
2. Simplified set up that may possibly increase operating room efficiency;
3. Dual-mode energy control to increase procedure focus;
4. Improved mobility secondary to cordless system.

Currently all devices are connected to a generator by a cable, which can lead to the cable wrapping around the device, tangle with other instruments and become inadvertently contaminated. There are several advantages with regards to utilization of a cordless device to include: improved intra-operative storage, avoidance of bundling multiple cords from various instruments that may limit instrument mobility and portability which may lead to the ability to operate with advanced surgical equipment in third world settings, trauma and surgery centers.

The study group will consist of 150 patients, male and female adults, who present with the need for general surgery in which an ultrasonic dissection device and/or a vessel sealing device will be utilized. Patients will be identified prospectively via consultation with the general surgeon. Data will be collected addressing the following variables: versatility, dissection time, vessel diameter, reliability, efficiency, tissue response, steam production, blood loss, tissue response, thermal spread, desiccation and sealing time. A tentative total of ten individual tissue specimens will be obtained by the surgeon during surgery and after the utilization of the Sonicision Cordless Ultrasonic Dissection System. The patient's histologic sample will be followed after surgery in order to determine efficacy of the vessel seal. Subsequently, the patient's information will be deidentified and the patient assigned a study number to which all further analysis will be tied. Patient participation will include time of surgery through discharge from the hospital. Study data will be collected and managed utilizing an electronic database.

Eligibility Criteria:
Inclusion Criteria:

General surgery in which an ultrasonic dissection device will be utilized Adult male and females age 18 and older

Exclusion Criteria:

Surgery involving bone Surgery involving contraceptive tubal occlusion Indication for emergency surgery Suspected inability or the inability to comply with trial procedures Employee at the investigational center, sponsor or sponsor's representative, relative or spouse of the investigator Emergency Surgery
Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial

The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone \> 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.

Each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. Eligible patients who agreed to participate will be randomized to either long acting standard COS with corifollitropin alpha or standard COS with daily FSH in a fixed GnRH antagonist protocol. All patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment.

The endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (E2), FSH and LH at different time points: basal condition, during stimulation, at the hCG day and at pick-up.

Transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hCG administration. The day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. Follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy.

The entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Indication to IVF treatment
* Normal BMI (18.5-24.9 kg/m2)
* AMH level \< 1.1 ng/ml and/or AFC \< 5 follicles and/or \< 3 oo-cytes retrieved in previous cycle
* Regular menstrual cycles
* Signed informed consent

Exclusion Criteria:

* Freeze all cycles for abnormal bleeding
* PCOS
* History of untreated autoimmune
* Endocrine or metabolic disorders
* Ovarian cystectomy or oophorectomy
* FSH ≥ 20 lU/L
A Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH）

This is a multicenter, randomized, open-label phase 2 study. Adult Patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HSK39297 for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants ≥ 18 years of age;
2. Diagnosis of PNH based on flow cytometry with clone size \> 10% by granulocytes;
3. Have not received complement inhibitor treatment;
4. Blood lactate dehydrogenase(LDH) values \> 1.5 ×upper limit of the normal range (ULN) ;
5. Hemoglobin level \< 100 g/L during the screening period.

Exclusion Criteria:

1. Hereditary or acquired complement deficiency;
2. Active primary or secondary immunodeficiency;
3. History of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants;
4. History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis;
5. Patients with laboratory evidence of bone marrow failure (reticulocytes \< 100x10\^9/L, or platelets \< 30x10\^9/L or neutrophils \< 0.5x10\^9/L) ;
6. Active systemic infection within 2 weeks prior to study drug administration;
7. History of serious comorbidities that have been determined to be unsuitable for participation in the study.
8. Pregnant or Lactating women.
The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery

This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.

The research team will be investigating the use of a novel type of local drug administration as well as assessing whether a non-opioid based drug will result in more positive pain outcomes while reducing reliance on narcotics (opioid-based drugs) following surgery.

The drug administration tool, called the Pecs blocks types I and II, utilizes ultrasound to help guide anesthetic injection for local anesthesia. This has been an effective way to deliver local anesthetic during breast surgeries. Meanwhile, a non-opioid analgesic drug (similar to an anesthetic, meaning it is used during surgery to reduce pain) called Exparel has been shown to reduce post-operative use of narcotics, length of stay in hospitals, and pain compared to the current standards in breast reconstruction surgery. Exparel is approved by the FDA for use in surgical sites during breast reconstruction surgery. Exparel has shown to reduce pain and post-surgical nausea and vomiting in breast reconstruction patients. However, the combination of Exparel with Pecs blocks has not been examined in breast reconstruction surgery, and the research team suspects that breast reconstruction patients who are administered Exparel with Pecs blocks will experience less pain, increased mobility, and less nausea following surgery. Furthermore, the researchers hope to show that this non-opioid based drug successfully reduces the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery.

The reason the project has three different groups in this study is to show if each group has different outcomes. First, the project hopes to see a difference between the Pecs blocks and normal anesthesia delivery. Then, researchers hope to see a difference between the two Pecs blocks group where the use of Exparel will result in less narcotic use, pain, nausea, and increase mobility.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects greater than 18 years of age.
2. Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.

Exclusion Criteria:

1. Subjects undergoing flap breast reconstruction.
2. Subjects who are undergoing direct-to-implant surgery.
3. Subjects who have previously undergone radiation therapy.
4. Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
5. Subjects who are pregnant at the date of surgery.