cyrilzakka/clinical-trials huggingface dataset:
Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination

Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm and seminal plasma linking the success or failure of the artificial insemination (IUI)

Analyze lipid profiles in samples of sperm and seminal plasma of three populations:

1. male sperm donors
2. men assigned to a program of assisted reproduction with normal sperm / slightly abnormal successfully in the IUI;
3. attached to a program of assisted reproduction with male semen Normal / slightly abnormal unsuccessfully in IUI

Establish partnerships between the composition of fatty acids, especially fatty acids polyunsaturated (PUFA) of the omega-3 (w3) series of samples analyzed parameterssemen and results of the IA to identify biochemical markers of fertility.

Assess markers found by checking the increase in the rate of success in the IA.

Eligibility Criteria:
Inclusion Criteria Group A women donor group

* Fallopian unobstructed Men donor group
* Appear as sperm donor
* Age between 18-35 years
* Sexual abstinence 3-5 days

Exclusion Criteria Group A:

* Uterine malformations (fibroids, adenomyosis, uterine malformations or acquired congenital) and fallopian tubes (tubal occlusion)
* Obesity BMI (Body Mass Index)\> 30 kg / m2
* Presence of altered tubal toxic habits (smoking\> 15 cigarettes per day, alcohol or drug abuse).

Inclusión / Exclusion Criteria Group B and C:

* ≤ 38 years
* Natural cycles and stimulated
* The criteria inclusion / exclusion group A
* Time sterility not exceeding three years.
A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis

Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).

This is a randomized, double-blind, two arm, parallel-group, vehicle-controlled, multi-center study of NB-001. The study is designed to demonstrate the safety and efficacy of NB-001 in subjects with RHL. Approximately 850 subjects who meet all eligibility criteria will be randomized in the study. Subjects will begin treatment as soon as they experience the onset of cold sore symptoms. Treatment will be applied 5 times daily, approximately 3-4 hours apart while awake. Treatment will continue until the investigator assesses the primary lesion complex as healed or a maximum of 4 days.

Clinic visits will occur on a daily basis until the investigator determines that the primary lesion complex has healed or a maximum of 15 clinic visits. At daily clinic visits, the investigator will make efficacy assessments of the primary lesion complex; safety and tolerability assessments of NB-001 following topical administration will also be assessed daily. Subjects will make daily assessments of therapy.

At the End of Study, the investigator will make a global assessment of therapy. The subject will make global assessments of therapy and social impact.

Eligibility Criteria:
Inclusion Criteria:

* A Healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigator's discretion) be included in the study.
* Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous 12 months;
* Have the majority of their cold sore recurrences proceeded by a well defined history of prodromal symptoms.

Exclusion Criteria:

* Subjects with severe chronic illness
* Received (within the last 6 months) or receiving chemotherapy;
* Significant skin disease on the face
* Previously received herpes vaccine;
* Active alcohol or drug abuse;
* Prior randomization into any NanoBio study;
* Known allergies to topical creams, ointments or other topical medications.
Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD

This open-labeled, one-center study is designed to evaluate the efficacy and safety of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5 who are receiving dialysis or not. The study will enroll patients between the ages of 2 to \<18 years. Approximately 30 patients will be enrolled.

This study is to evaluate the use of roxadustat for renal anemia in pediatric patients with CKD

Eligibility Criteria:
Inclusion Criteria:

1. Estimated glomerular filtration rate (Bedside Schwartz formula) of \< 60 ml/min/1.73 m2 (stage 3, 4 and 5 CKD) for dialysis or non-dialysis patients.
2. For ESA-naïve patients, mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be \< 11.0 g/dL. For patients currently receiving stable ESA dosing who will discontinue ESA and convert to roxadustat during study, mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be ≥ 9.0 g/dL and ≤ 12.5 g/dL
3. Ferritin \>50 ng/mL and transferrin saturation \>10%

Exclusion Criteria:

1. Uncontrolled hypertension as judged by the principal investigator prior to screening.
2. Known hematologic disease related anemia (including PRCA)
3. Known malignancy within the past 5 years before screening.
4. History of severe anaphylaxis or known allergic to ingredient of roxadusta.
5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN) and total bilirubin (Tbili) ≤2x ULN(obtained from screening visit).
6. Serum folate and vitamin B12 \> LLN and cannot be corrected (obtained from screening visit).
7. Any RBC transfusion during the past 4 weeks before screening.
8. Weight\<10kg
9. Any prior exposure to roxadustat or any other HIF-PH inhibitor.
Brain Connectivity in Age-Related Macular Degeneration

This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function. The study team will assess whether the "brain signatures" associated with specific cognitive deficits differ in older adults with and without AMD.


Eligibility Criteria:
Inclusion Criteria:

AMD

- Vision loss attributable to AMD

Controls

* Age match (± 5 yrs)
* Gender match
* Education match (± 4yrs)
* Normal macular exam

Exclusion Criteria:

AMD

* Other significant eye pathology
* Mod/severe dementia
* Communication barrier that precludes testing

Controls

* Other significant eye pathology
* Mod/severe dementia
* Communication barrier that precludes testing

MRI subset

* Devices or material incompatible with 3.0 Tesla MRI
* Conditions that may interfere with interpretation of fMRI (e.g. history of stroke, brain tumor or previous brain surgery; psychoactive medications; seizure disorder)
* Claustrophobia
* Left-handed
* Body weight \> 300 lbs
* Pregnant women
Massage and Electroacupuncture in Chronic Lumbar Pain

The aim of this study is to evaluate and compare in patients with chronic back pain two therapeutic interventions: a) the combination of massage and electroacupuncture; and b) the application of epidural analgesia in pain, functioning-incompetence, quality of life and mood.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from lumbar pain of benign etiology
* Age 20 to 65 years

Exclusion Criteria:

* Ages over 65 or below 20 years
* Neoplasms (benign or malignant etiology)
* Contagious or infectious disease
* Dermopathy
* Pregnancy
* Alcohol or drug use
* Previous use of epidural analgesia
* Systemic opioid use
* Severe heart disease
* Fever for more than one sessions
* Allergy to the oil which will be used and its derivatives
* Thrombi or varicose veins
* Psychiatric disease
Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic

Telemedicine is a solution to overcome distance and ensure the provision of healthcare services. This study aims to investigate the effects of conducting outpatient clinic visits remotely, for patients living with insulin pumps.

Telemedicine also has the potential to be a cost-effective solution due to reductions in travelling costs and saved working days, as well as increased patient satisfaction due to the reduction in transportation time.

Several studies have evaluated telemedicine for use in Diabetes Mellitus patients with an insulin pump. In all of these studies, the telemedicine group scheduled more contacts with the health care professionals than in the standard care group. To the investigator's knowledge, no one has investigated telemedicine, compared to standard care with the same number of scheduled contacts. The investigators believe telemedicine should increase the level of service and not increase the workload for health care professionals. A telemedical solution can provide patients with a more flexible alternative for visiting their health care provider rather having the burden of extra telemedicine appointments plus regular treatment.

Patients in rural Denmark may have a travelling time of 70 km (1 hour by car or several hours by public transport) to a specialised Diabetes Mellitus specialist centre. This may result in some patients choosing not to start or not being offered insulin pump treatment despite indications that an insulin pump is an optimal treatment choice. The challenge of distance also poses problems for patients in relation to technical problems or medical issues with the insulin pump. Telemedicine should be a solution for both patients and their Health Care Providers.

In this randomised controlled study, the effects of conducting clinical visits remotely, for patients living with insulin pumps will be investigated. Participants will be allocated to either Intervention (Standard care provide by video consultations) or standard care.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age
* Diagnosed with diabetes Type 1
* Patient has used insulin pump for at least 6 months

Exclusion Criteria:

* No internet access
* Unable to adhere to protocol.
* Unable to speak or read Danish.
Influence of Sensory Block Duration on Rebound Pain After Outpatient Foot Surgery Under Popliteal Sciatic Nerve Block.

Rebound pain after surgeries under peripheral nerve block is defined as the appearance of severe acute postoperative pain after regression of the sensory block. The incidence of this condition can reach up to 40-50% in patients undergoing ambulatory surgeries. Rebound pain represents a clinically significant issue that may outweigh the benefits of regional anaesthesia. This is particularly significant for painful outpatient surgeries, where inadequately managed pain can result in distress, potentially affecting patient satisfaction and recovery. It may also lead to unplanned utilization of healthcare resources or readmissions.

Orthopaedic foot surgery is a prevalent outpatient surgery, potentially painful, where rebound may be a difficult challenge. However, to date, prospective studies focusing specifically on rebound pain in outpatient foot surgery are limited. Identifying conditions associated with rebound pain or at-risk patients could facilitate the development of preventive and treatment strategies, thereby enhancing pain management or relief. Younger age, female sex and bone surgery are non-modifiable factors associated with severe rebound pain. Perioperative intravenous dexamethasone has been identified as a modifiable independent risk factor associated with a reduced incidence of rebound pain. Regarding anaesthetic factors, the duration of the peripheral block has been proposed as a potentially modifiable factor influencing rebound pain; however, current evidence does not support this hypothesis.

The goal of this prospective observational study is to evaluate the incidence of rebound pain specifically in outpatient orthopaedic foot surgery involving bone under popliteal sciatic nerve block and to assess the possible association between sensory block duration and the incidence of rebound pain.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (\>18 years old), ASA physical status 1 to 3, scheduled for elective outpatient orthopaedic foot surgery involving bone under popliteal sciatic nerve block.

Exclusion Criteria:

* age younger than 18 years, ASA physical status greater than 3, surgery not performed under popliteal sciatic nerve block or cases of failed sciatic nerve block, patients with type-1 diabetes or those under treatment for chronic pain.
Dexmedetomidine As an Adjuvant to Bupivacaine in Bilateral PECs for Pain Control After Cardiac Surgeries

the study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.

Background: Good postoperative analgesia in cardiac surgical patients helps in early recovery and ambulation. An alternative to parenteral, paravertebral, and thoracic epidural analgesia can be pectoralis nerve (Pecs) block, which is a novel, less invasive regional analgesic technique.

The study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.

sixty adult patients between the age groups of 25 and 65 years undergoing coronary artery bypass grafting or valve surgeries through midline sternotomy under general anesthesia were enrolled in the study. Patients were randomly allocated into two groups with 30 ineach group. Group 1 patients will receive bilateral Pecs block, whereas Group 2 patients will receive bilateral Pecs block with dexameditomedine postoperatively. Patients will be extubated once they fulfilled extubation criteria. Ventilator duration will be recorded. Patients will be interrogated for pain by visual analog scale (VAS) scoring at rest and cough. Inspiratory flow rate will be assessed using incentive spirometry.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients between the age groups of 25 and 65 years undergoing either coronary artery bypass grafting (CABG) or valve surgeries through midline sternotomy under general anesthesia

Exclusion Criteria:

* Skin erosions, hematomas or infection at the injection site.
* coagulopathy, ACT more than 150 seconds
* History of hypersensitivity to bupivacaine or Dexametomedine.
* The Patients who are unable to use the pain score.
* patients who will need prolonged post-operative ventilation or inotropic support.
Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids

Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for therapy of bullous pemphigoid will be evaluated the score using pemphigus disease area index (PDAI) and pemphigoid activity score involving skin lesion area and Number of new blisters.

As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 57 days after the start of the study treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with corticosteroids over 0.4mg/kg/day(Prednisolone) at informed consent.
2. Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
3. Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more before study medication received.
4. Patients who the score using Pemphigus Disease Area Index(PDAI) is not improve before study medication received.
5. Patients with twenty years old at informed consent.
6. Patients with hospitalization during five consecutive days of study medication and seven consecutive days after administration of study medication .

Exclusion Criteria:

1. Patients treated with plasmapheresis at 28 days before informed consent.
2. Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent.
3. Patients treated with intravenous immunoglobulin at 56 days before informed consent.
4. Patients who receive or adjust in increments immunosuppressants at 14 days before informed consent.
5. Patients with malignancy or a history of this disease.
6. Patients with history of shock for NPB-01.
7. Patients with history of hypersensitivity for NPB-01.
8. Patients with IgA deficiency.
9. Patients with impaired liver function.
10. Patients with impaired renal function.
11. Patients with cerebro- or cardiovascular disorders.
12. Patients with high risk of thromboembolism.
13. Patients with hemolytic/hemorrhagic anemia.
14. Patients with decreased cardiac function.
15. Patients with decreased platelet.
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast cancer
* No previous treatment with taxanes, and vinca alkaloids
* Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

* More than 2 previous chemotherapies
* Previous participation in another trial within the last 4 weeks
* Breast feeding
* Active infections
Screening for Genes in Patients With Congenital Neutropenia

Syndromic congenital neutropenia (SCN) includes a heterogeneous group of diseases characterized by congenital neutropenia associated with the involvement of other organs. Most patients have syndromic congenital neutropenia, which does not correspond, either clinically or genetically, to any other previously described form. A large number of genes still have to be identified in these syndromic forms.

The aim of this study is to identify the molecular bases of congenital neutropenias that have not yet been classified, by taking advantage of high-throughput exome sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Persons who have provided written consent
* Patients with congenital neutropenia and mental retardation and/or a development anomaly (malformation, facial dysmorphism)
* Patients who accept a clinical evaluation, and to give at least one blood sample
* Screening for chromosomal microrearrangements by normal array-CGH

Exclusion Criteria:

* Persons without national health insurance cover
* Patients who do not meet the clinical and/or biological criteria
* Refusal to give written consent to take part in the study
* Refusal to give a blood sample
* Blood samples from parents not available
Specimen Collection Study Protocol

The specimens collected will be used to evaluate matrix equivalency in an immunoassay in development for the detection of IgG or IgA or IgM antibodies to SARS - CoV2 in human serum. These reagents are for in vitro diagnostic use only.

The objective of this study is to acquire paired serum, plasma and whole blood collected on a collection card from subjects with no known history of COVID-19 infection. The specimens will be collected at Biomerica in Irvine CA for specimen collection, banking, and matrix equivalency studies for projects in development at Biomerica for detection to IgG or IgA or IgM antibodies to Sars-CoV2 antibodies. Subject will also be asked to self-collect a nasal swab for COVID-19 PCR

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 and older
* Able to read, speak, and understand English
* Must weigh a minimum of 110 pounds
* Willing and able to donate 20 mLs of whole blood via venipuncture. \[approximately ˂ 2 tablespoons\]
* Willing and able to donate 0.040 mLs of whole blood via fingerstick
* Willing and able to sign the informed consent (self or authorized representative)
* Willing and able to self-collect a nasal swab per the provided instruction shee

Exclusion Criteria:

* Aged less than 21 years old
* Unable to provide consent.
* Unable to donate blood via venipuncture and fingerstick.
* Unable to self-collect a nasal swab
Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial

The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp \& suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.

Patients booked for total abdominal hysterectomy in Southern Health will be offered participation in the trial, and randomised to two groups: one group undergoing the procedure with the gyrus forceps \& the other group with the traditional clamp \& suture method. Each patient will receive detailed information regarding the study both in document form as well as verbally by the Gynaecology doctors in the pre-admission clinic prior to obtaining consent.

The researcher will collect relevant data including age of patient, medical \& surgical history and data relating to both the primary \& secondary outcome measures, which include length of operation, intra-operative blood loss,post-operative pain measures as well as length of hospital stay \& cost.

A qualified statistician will perform power calculations and analyse the data collected, looking at the outcome measures mentioned above.

Electrical surgery has been used extensively in surgery, especially in laparoscopic surgery, and the use of these newer electrocoagulation forceps that can simultaneously haemostatically seal \& cut tissue is again well established in laparoscopic surgery but only more recently introduced to open surgical procedures. To date, except for 1 pilot study, there are no randomised control trials that confirm the proposed benefits of these newer device in abdominal hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Any patient already on waitlist in Southern Health for abdominal hysterectomy with suspected benign pathology

Exclusion Criteria:

* Patients without consent and/or with suspected malignant pathology