cyrilzakka/clinical-trials huggingface dataset:
Effect of Abstinence Duration on Embryo Development

The aim the investigators study is to analyze the embryo development if oocytes of the participants are injected with sperm from a longer or shorter (2 hours) abstinence duration.

Participants undergoing an IVF treatment, are asked to respect an abstinence duration of 2-7 days. This is to obtain a sufficient number of motile sperm. A recent investigation, analyzed the quality (number and motility) of a sperm sample produced after an abstinence duration of 4 to 7 days, followed by a second sperm sample 2 hours later. The second sample (after 2 hours) was able to produce sperm cells with a higher motility. Not only has this short abstinence duration of 2 hours a positive effect on the motility, it will also reduce the sperm DNA damage, which again has a positive effect on embryo development. Because participants need gametes of high quality to obtain embryos with a high quality, the investigators want to investigate what the effect is of abstinence duration on embryo development.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for embryo development up to day 5
* at least 6 mature oocytes
* fresh ejaculates
* ICSI
* fresh embryo transfer or freeze all strategy
* all stimulation protocols
* concentration of \>1x10\^6 /ml sperm

Exclusion Criteria:

* IVF
* IVF versus ICSI patients
* chirurgical sperm
* acceptors of donor oocytes
* patients with PGD
* patients already enrolled in another study
Evaluation of Optical Coherence Tomography.

Determination of the sensitivity and specificity of different combinations of imaging techniques (spectral domain optical coherence tomography, fundus photography and fluorescein angiography) used for the diagnosis of choroidal neovessels complicating age -related macular degeneration. This information will help to determine the choice of the most suitable combination for the above diagnosis.

The following combinations will be studied: spectral domain optical coherence tomography (OCT) + fundus photography; fluorescein angiography + fundus photography and the combination of all three techniques (OCT+ fundus photography + fluorescein angiography).The sensitivity and specificity of the latter combination will be assessed by comparison with the results for this combination reported by several readers. Inter- and intra-observer reproducibility of the different combinations will also be studied.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 50 years
* First visit for suspicion of choroidal neo-vessels complicating age related macular degeneration
* Fundus color photographs , FLUORESCEIN angiography and OCT prescription

Exclusion Criteria:

* Age \< 50 years
* Diabetes
* Central vein occlusion Macular hole Epi-retinal membrane Retinal detachment Macular hemorrhage more than the 1/3 of the lesion
* History of macular laser, PDT or intra-vitreal injection
of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).

An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who was diagnosed as diabetes
* Subjects who was diagnosed as dyslipidaemia or takes lipid lowering medication
* Clinic visit in the past 6 months more than once

Exclusion Criteria:

* Subjects who are unwilling or unable to provide their examination and lab result of medical chart.
Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis

a randomized controlled single-blinded study. the hypothesis of this clinical trial is that disjunctive use of diode laser improve the clinical parameters of periodontists , and there are significant difference between the conventional treatment and diode laser as an adjunct

A total of 240 sites with deep pocket in 30 systemically healthy patients with chronic periodontitis, from subjects attending Jordan University of Science and Technology (JUST) Postgraduate Dental Clinic (PDC), the age range were (28-55) year, between Apr 2017 and Oct 2017. Those patients were enrolled in a randomized controlled single-blinded study. For each patient, full medical and dental history and periodontal examination were recorded. Clinical parameters such as pocket depth (PD), clinical attachment loss (CAL), gingival index (GI) and plaque index (PI) were evaluated at the baseline. All Patients underwent initial periodontal therapy; SRP which was performed using a sonic device and hand instruments and the sites were divided randomly into two groups SRP alone and SRP with adjunctive diode 810 nm laser in the contralateral sites in the same jaw. The Clinical parameters have been re-evaluated at 1, 3 and 6 months to test the effectiveness of (810 nm, 2 W, pulsed mode, for 20 sec) in treatment of CP. Diode laser therapy was applied to periodontal pockets in the same day of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients having periodontitis in at least two quadrants each quadrant should have at least 4 sites with PD \>4mm.
* Both male and female patients.
* Patient who are ready to cooperate with diode laser treatment.
* Patient who can comply with 3 visits for follow up (three times).

Exclusion Criteria:

* Subjects with systemic diseases that may interfere with wound healing (such as diabetes) or any systemic disease that complicates the treatment.
* Pregnant women and breast feeding.
* Smokers, alcohol or drug dependent.
* Patients who received any form of periodontal treatment within the last 6 months.
* Patients who are currently taking or were on antibiotic treatment within the last 6 months.
* Presence of faulty restoration at teeth involved in the disease.
* Teeth indicated for extraction at sites that will be part of the study.
* Patient under 18 years of age.
Accuracy Evaluation of Artificial Intelligence Assisted Liver Tumor Ablation Path Planning

CT-guided microwave ablation is one of the important treatment methods for primary or metastatic liver tumors. It has the advantages of minimally invasive, safe, and economical. For liver tumors with a diameter of less than 3 cm, it can be comparable to surgical resection. However, different doctors have different levels of experience, leading to a high risk of residues after ablation and even complications. The key is to fail to plan the needle placement reasonably. The past research on path planning was mostly conducted by the engineering team, so that the actual clinical needs were not considered comprehensively, and the sample size of verified cases was small, which limited the application of existing models in the clinical application. In previous study, we used artificial intelligence to segment the upper abdominal organs and construct the constraint function to establish the ablation path planning model, and initially verified the effectiveness of the path planning model in a small number of cases. Now it is planned to expand the number of patients enrolled to evaluate the accuracy of the ablation path planning model that we have established.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old patients with liver tumors, not limited to primary liver cancer or secondary liver metastases;
2. The number of tumors is less than 5;
3. The diameter of the tumor is less than 3 cm;
4. No local treatment of intrahepatic tumors has been done in the past.

Exclusion Criteria:

1. Diffuse liver tumor;
2. Multiple lesions in the liver\> 3cm, which cannot be completely ablated;
3. Patients with lymph node metastasis and distant metastasis outside the liver;
4. Other situations where the researcher believes that it is necessary to withdraw from the study
Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases

This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.

This is an investigator-initiated trial to evaluate the safety and efficacy of universal CD19/BCMA CAR T-cells in Relapsed or Refractory Neurological Autoimmune Diseases.

Study intervention consists of a single infusion of universal CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

Interim analysis will be performed when participants finish the visit 90 days after CAR T-cell infusion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.
* Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).
* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
* Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.

Exclusion Criteria:

* Subjects with a history of severe drug allergies or allergic tendencies.
* History of malignancy within five years.
* Subjects with insufficient cardiac function.
* Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.
* Pregnant women or women planning to conceive.
18F-DTBZ for l Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET Imaging

The primary objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of Parkinson's Disease (PD) and normality. Secondary, the investigators will analyze the correlation between the 18F-DTBZ binding and the severity of disease of PD and the role of 18F-DTBZ PET in the monitoring disease severity.

25 age-matched healthy volunteers will be enrolled. For assessing the correlation between the 18F-DTBZ binding and the severity of disease, the patients with PD will be divided into three groups according to their motor scores: mild, moderate, and advanced. We will enroll 25 patients in each group. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit.

Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders and 50\~80 years old.
2. Written and dated informed consent by self or by legal representative, to be obtained before any of the study procedures
3. Healthy male or female subjects with no evidence of significant neurologic impairment by history.
4. Seventy-five PD subjects will be divided as three subgroups according to the severity of disease: mild (Modified Hoehn and Yahr stage 1 to 2), moderate (Modified Hoehn and Yahr stage 2.5 to 3), and advanced (Modified Hoehn and Yahr stage 4 to 5).
5. All the PD subjects should be fulfilled the UK Parkinson's Disease Society Brain Bank criteria of "possible" or "probable" PD. The age of disease onset should be older than 50 years.

Exclusion Criteria:

1. Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.
2. Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
3. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
4. History or presence of QTc prolongation.
5. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
6. Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus, multiple infarction and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed.
7. Patients who have the evidence of secondary
Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring

This study aims to compare the time difference between radial arterial line placement and use of the EndoPhys sheath, as well as, assess the cost effectiveness of the EnoPhys sheath vs. use of a radial arterial line based on device and operating room costs.


Eligibility Criteria:
Inclusion Criteria:

* All elective neuro endovascular procedures requiring general anesthesia and continuous invasive blood pressure monitoring
* Adequate access to both the radial or femoral artery

Exclusion Criteria:

* Pre-operative identification of contra-indication for radial arterial line placement
* Hemodynamic instability
* Need for continued post-operative invasive blood pressure monitoring
* Failure to obtain informed consent
Comparison of Fiberoptic Intubation With Fiberoptic Intubation Through an Air-Q Intubating Laryngeal Airway in Infants and Small Children

The goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The question the investigators are trying to answer is: Does the operator experience make a significant difference in the time for successful fiberoptic guided tracheal intubation with and without the use of an air-Q intubating laryngeal airway?

The aim of this study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The ease and time for placement of the air-Q, fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, and peri-operative complications will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (ASA I to III) children who will be intubated as part of their general anesthesia plan for their scheduled surgeries
* Age 1 month - 2 years
* Weight 1-20 Kg

Exclusion Criteria:

* Children with active respiratory infection
* Known history of difficult mask ventilation
* Diagnosis of a congenital syndrome associated with difficult airway management
* Airway abnormalities (e.g., laryngomalacia, subglottic stenosis).
A Study of Oral Contraception Under Simulated OTC Conditions

This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting.

Subjects will be primarily recruited via passive recruiting methods, such as in-store posters, direct mail postcards, and digital space advertising.

Respondents to advertisements will either call Clinical Research Organization (CRO) call center or visit the study website for initial screening (during which data regarding age, gender, and minimal study exclusion criteria will be collected) and scheduling of an in-person enrollment visit at a local participating research site.

During the face-to-face enrollment visit, potential subjects who meet the inclusion and exclusion criteria for the study will be given an (empty) study medication package and will be allowed as much time as they need to review the information on the outside of the entire package. Subjects will then be asked if the product is OK or not OK for them to use.

Qualified subjects then will be allowed to purchase (pharmacy sites) or be given (clinic sites) the study product.

Approximately 47 sites will be used, comprising retail pharmacy research sites and women's health clinics or adolescents' clinics.

Eligibility Criteria:
Inclusion Criteria:

-Women who are willing purchase (in the pharmacies) or be provided (in the clinics) oral contraception for their own use for the purposes of the study

Exclusion Criteria:

* Cannot read, speak and understand English
* Cannot see well enough to read information on the label
Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.

To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.


Eligibility Criteria:
Inclusion Criteria:

* Integral buccal mucous (without oral pathologies);
* Normal odontological exams;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Antiinflammatory or immunosuppression drugs 15 days before the study;
* Being in odontological treatment;
* Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
* Personal history of allergic disease in the area to be treated;
* Allergic or atopic history;
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002

An observational study to prospectively follow-up the patients enrolled in the ISS T-002 clinical trial up to 132 weeks. The primary endpoint of this study is to evaluate the persistence, in term of frequency, magnitude and quality, of the anti-Tat humoral and cellular immune response in the HIV-1 infected individuals who participated to the ISS T-002 and who have received at least 3 immunizations. The secondary endpoint is to define and validate novel laboratory tests for future efficacy clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in the ISS T-002 trial, having received at least 3 immunizations;
* A follow-up of at least 48 weeks during the ISS T-002 study;
* Availability to participate in the extended follow-up study;
* Signed informed consent.

Exclusion Criteria:

* The absence of any of the above criteria will exclude the subjects from the study.
The Effect of an Exercise Program on Physical Function After a Spinal Cord Injury

This study would focus on adding a group exercise program to the usual therapy delivered in the hospital. We propose to design an exercise program that would be 30 minutes in length, 3 times per week. A medical doctor and physiotherapist would oversee the design and monitoring of the program.

We believe that this program will: 1) Increase the potential for better health, thus improving independence and quality of life; 2) Help people make the move from therapist run exercise to self management of exercise; 3) Engage the patient in the therapy process and place an expectation of active participation on the client; and 4) Promote physical activity as part of a healthy lifestyle.

In total 30 participants admitted for spinal cord injury rehabilitation at GF Strong Rehabilitation Centre will be randomly assigned to either cardiovascular training group or balance training group. The cardiovascular training group will receive their usual therapy plus 3 days of 30 minutes of exercise per week. This program will last for 6 weeks while the participant is in the hospital. The cardiovascular training program will include pushing and pulling on pulleys, wheeling over mats, punching a boxing bag, and using an arm ergometer. The balance training group will receive their usual therapy plus 3 days of 30 minutes of sitting balance activities. This program will last for 6 weeks while the participant is in the hospital. The balance training program will include sitting on mats - moving arm support from in front of the body to behind body, moving from sitting to lying and back up, and catching soft foam ball thrown directly to centre of chest and throwing it back.

Eligibility Criteria:
Inclusion Criteria:

1. Sustained a traumatic spinal cord injury,
2. 16-50 years of age,
3. Able to push a manual wheelchair and arm ergometer,
4. Able to participate in exercise three times per week for 30 minutes,
5. Able to follow English instructions.

Exclusion Criteria:

1. Unstable cardiovascular status (congestive heart failure, uncontrolled hypertension, uncontrolled atrial fibrillation, or left ventricular failure),
2. Significant musculo-skeletal problems (e.g., rheumatoid arthritis) or neurological conditions (e.g., Parkinson's disease) due to conditions other than spinal cord injury,
3. Increased pain with exercise.
Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression

There have been reports suggesting that continuous administration of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is advantageous for patients in which gradual disease progression was observed after the establishment of clinical benefit from EGFR-TKIs. However, whether EGFR TKI with or without chemotherapy provides more survival benefit has not been formally evaluated.

We design this clinical trial to compare the efficacy of continuation of EGFR TKI with or without chemotherapy in patients beyond gradual progression.

Eligibility Criteria:
Inclusion criteria:

Patient who was confirmed stage IV NSCLC by pathologic histology or cytology. Males or females aged ≥18 years, \< 75 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.

Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.

Definition of gradual progression:

1. Slow PD (6 months of partial response/stable disease),
2. Asymptomatic minimal PD,
3. New brain metastasis controlled locally. Patients with asymptomatic, treated brain metastases are eligible for trial participation.

Adequate bone marrow, renal, and liver function are required. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion criteria： Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.

Female subjects should not be pregnant or breast-feeding. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.

Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT )and Aspartate Aminotransferase (AST )\< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases.

Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.