cyrilzakka/clinical-trials huggingface dataset:
Age of Exposure and Immunity to Malaria in Infants

The overall objective is to evaluate the effect of exposure to Plasmodium (P.) falciparum erythrocytic stage antigens during different periods of infancy on the development of naturally acquired immunity (NAI).

Hypothesis: Exposure to P. falciparum prior to 5 months of age does not result in the development of NAI, while exposure to P. falciparum after 5 months of age leads to the development of NAI. The risks of clinical malaria and anaemia during the second year of life will be compared between cohorts, as well as their correlations with the type and quality of immune responses (antibodies to several P. falciparum antigens, cytokines), oxidative stress markers and host genetic factors. These results should shed light on the determinants of the development of anti-P. falciparum responses early in life and the potential constraints to early life immunisation.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for pregnant women:

* Healthy HIV-negative pregnant females less than 50 years of age who attend the voluntary counseling and testing (VCT) center at the Maragra or Manhiça antenatal clinic,
* Permanent residents of the Manhiça area and expecting to be living in the area with their infant for at least 2 years.

Inclusion criteria for newborn infants:

* Healthy infants, weighing \>= 2 kg and having an alive mother.

Exclusion Criteria:

Exclusion criteria for pregnant women:

* Plan to leave the area in less than 2 years from the start of the study;
* Women not willing to get tested for HIV infection at the VCT center;
* Test positive for HIV;
* Not willing to provide informed consent;
* Cannot understand either Portuguese or Changana (consent forms are written in these languages).

Exclusion criteria for newborn infants:

* Any obvious congenital malformation;
* Any signs of cerebral asphyxia;
* Any obvious neonatal infection;
* Same gender Twins;
* Low birth weight (\<2 kg).
Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device.

The purpose of this study is to detect new ischemic lesions after carotid artery stenting (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by diffusion-weighted magnetic resonance imaging (DW-MRI), using the endovascular proximal flow blockage (Mo.Ma device) for cerebral protection.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old;
2. Eligibility for carotid artery revascularization;
3. A significant stenosis in symptomatic patients with ≥ 50% Diameter Stenosis (%DS) or asymptomatic ≥ 80 %DS as defined by angiography.

   Symptomatic is defined as a carotid artery stenosis associated with ipsilateral TIA, amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
4. Suitable clinical conditions to perform DW-MRI.
5. Written informed consent as approved by the Ethics Committee of the respective clinical site.

Exclusion Criteria:

1. Female with childbearing potential without a negative pregnancy test.
2. Life-expectancy less than 6 months.
3. Underlying disease of the carotid artery other than atherosclerosis (e.g. vasculitis, traumatic dissection, fibromuscular dysplasia).
4. Prior stenting in the target vessel;
5. Patients with chronic or re-current atrial fibrillation.
6. Patient has had a Myocardial Infarction within 72 hours prior to the procedure.
7. Patient experienced a stroke within 4 weeks prior to the procedure.
8. History of severe disabling stroke according to the modified Rankin scale \> 4.
9. Severe renal failure (serum creatinine \> 2.0 mg/dL).
10. Severe peripheral arterial occlusive disease, which might impede a safe introduction of a 9F-sheath for the use of a Mo.Ma-device.
11. Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Statins, Heparin, Nitinol, contrast agents (that cannot be adequately pre-medicated).
12. Patient currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the DESERVE study endpoints.
13. Any planned major surgery within 30 days after the study procedure.
14. In the investigators opinion patient has a severe co-morbid condition(s) that could limit the ability to participate in the study.

    Angiographic exclusion criteria:
15. Totally occluded internal carotid artery considered as the target vessel.
16. Multiple internal carotid artery stenoses or lesion longer than 4 cm (whichever occurs) that cannot be covered by one (1) stent.
17. Severe ostial stenosis of the common carotid artery.
18. The presence of ipsilateral intracranial stenosis that requires treatment.
19. Contralateral occlusion of the internal carotid arteries associated with a poor collateral flow through the circle of Willis.
20. An aortic arch anatomical complexity that may preclude the safe placement of the Mo.Ma device including particularly, the impossibility to navigate a stiff guide wire into the external carotid artery.
Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China

The purpose of this study is to develop the electronic management platform for children with epilepsy, establish large data of Chinese children with epilepsy and explore its biological etiology.

The establishment of the electronic management platform for children with epilepsy and large data of epilepsy in Chinese children as well as the epidemiological study its biological etiology.

Eligibility Criteria:
Inclusion Criteria:

* Children with epilepsy diagnosis, seizure types and causes of disease classification in accordance with the International Association for the diagnosis and treatment of epilepsy in 2015 guidelines
* Epilepsy children Included 0-14 years old from outpatients and inpatients by the Children's epilepsy specialist using iGrowSys management platform and clinical research, and medical records data entry complete in all China

Exclusion Criteria:

* The patients that recorded data is not complete, telephone and communication address unknown
* The patients that families do not have Internet or children and families will not access the Internet, can not be online operation
Screening of Microalbuminuria Using a Semi-quantitative UACR Test

Microalbuminuria is an important biomarker for the development of diabetic nephropathy and cardiovascular complications. Since microalbuminuria is not easily detected on routine urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio (uACR) annually in a patient with diabetes mellitus. While the standard method is quantitative measurement using turbidimetric immunoassay, it requires high cost and special laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and inexpensive, could be used as a substitute to the current standard quantitative measurement. The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* diabetes

Exclusion Criteria:

* microscopic hematuria
* pyuria
* urinary cast
Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism

The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).


Eligibility Criteria:
Inclusion Criteria:

* Must sign an Informed Consent document;
* Wear toric soft contact lenses within the protocol-specified range;
* Cylinder equal or higher than -0.75 diopters (D) in both eyes;
* Have an acceptable fit with both study contact lenses;
* Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
* Best corrected visual acuity (BCVA) of 20/30 Snellen;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Require presbyopic correction;
* Any ocular condition observed during examination at the enrollment visit;
* History of herpetic keratitis, ocular surgery or irregular cornea;
* Pregnant or lactating;
* Participation in any clinical trial within 30 days of the enrollment visit;
* Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
* Other protocol-specified exclusion criteria may apply.
Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca

This is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube cancer patients.

Day 1 of each 21 day Cycle:

Paclitaxel 175 mg/m2 IV (infused over 3 hours)

Day 1 or 2 of each Cycle Adequate IV hydration with normal saline (1000 ml recommended)followed by intraperitoneal infusion of 500 ml normal saline through the IP port.

Cisplatin 75 mg/m2 reconstituted in 500 ml NS warmed to 37 degrees Celsius is infused IP (30 minute infusion)followed immediately by whole abdominal hyperthermia

Abdominal hyperthermia will be delivered using the BSD 2000 ellipse system to target temperatures of 40-42 degrees Celsius monitored via rectally and vaginally continuing for no greater than 60 minutes after maximal 30 minute warm-up phase. Total duration of hyperthermia will be no greater than 90 minutes.

Day 8:

Paclitaxel 60 mg/m2 IP. Paclitaxel will be diluted and filtered initially in 1000 ml of normal saline or D5W warmed to 37 degrees Celsius. For IP administration, the patient must receive an additional 1000 ml of normal saline degrees Celsius in the peritoneal cavity.

Cycles will be repeated every 3 weeks x 6 cycles. Patients will be followed until disease progression/recurrence or death.

Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed Stage III or Stage IV advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
* Optimal debulking (\< 1cm residual disease) of their disease within 6 weeks of the start of the study
* Patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy
* GOG performance status 0, 1, or 2
* Patients must have normal organ and marrow function defined as:
* absolute neutrophil count \>1,500/mcL
* platelets \>100,000/mcL
* total bilirubin and creatinine \<1.5 X institutional upper limit of normal(ULN)
* AST(SGOT)/ALT(SGPT)\<3 X institutional ULN

Exclusion Criteria:

* Patients with biochemical recurrences or evidence of measurable disease
* Patients with suboptimal (\>1 cm) residual disease
* Patients who have had chemotherapy within 4 weeks prior
* Receiving any investigational agents
* Known brain metastases
* Epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
* Uncontrolled intercurrent illness
* Prior radiation therapy
* History of other invasive or pre-invasive malignancies (except non-melanoma skin cancer) within the past 5 years
HEALS (Healthy Eating And Lifestyle After Stroke)

This lifestyle intervention plan will improve healthy lifestyle practices (diet, exercise, and smoking cessation) among stroke survivors and result in a reduction in measures of general and abdominal obesity.

Study data collection will consist of a baseline and outcome study visit. Each visit will consist of a survey and physical exam to collect height, weight and body measurements.

Outcome measures include:

1. Physical Activity: Collected via survey using a version of the International Physical Activity Questionnaire
2. Diet: Collected via survey using the Brief Dietary Assessment Tools for Hispanics
3. Body Mass Index (BMI): Collected via physical exam following the Alaska State Department of Health and Social Services BMI Guidelines
4. Abdominal Obesity: Collected via physical exam following the NIH Standard Circumference methods.

Eligibility Criteria:
Inclusion Criteria:

* Phase I: Completed 12 month SUSTAIN trial (SUSTAIN criteria: age ≥ 40 years, acute TIA or ischemic stroke within the prior one month and systolic blood pressure (SBP) \>120 mm Hg).
* Phase II: Stroke or TIA \> 3 months prior to screening date, age \> 20 years, blood pressure (SBP) \> 120 mm Hg.

Exclusion Criteria:

* Phase I and Phase II: Same as SUSTAIN criteria: medical condition limiting participation in follow up assessments, severe cognitive impairment (MMSE ≤24), and severe global disability (modified Rankin ≥3).
A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas

This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study.
* Aged \> 18
* Male and female participants
* Patients willing and able to attend follow up visits over a period of 6 months

Exclusion Criteria:

* Patients who require revision surgery.
* Having had previous arteriovenous fistula surgery is not a contraindication to recruitment provided the new procedure is not revision surgery
* Target arteries smaller than 3 mm in diameter
* Target vein smaller than 3 mm in diameter
* Stenotic veins on the side of surgery as diagnosed on pre-op ultrasound
* Patients with prior central venous stenosis or obstruction on the side of surgery
* Depth of vein greater than 8 mm (on US) on side of surgery
* Known coagulation disorder
* Prior steal
* Known allergy to nitinol
* Life expectancy less than 6 months
* Inability to give consent and/or comply with the study follow up schedule
* Women of child bearing age
Pharmacological Treatment of Presbyopia

In this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. The right eyes of 45 patients will be treated by Biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. In another case group, the right eyes of 30 patients will received Vuity® eye drops and their left eyes will be considered as controls.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with the best corrected visual acuity (BCVA) better than 0.3LogMAR
* Patients with the symptom of blurred vision at near distance

Exclusion Criteria:

Patients with amblyopia, cataract, corneal opacity, glaucoma, intraocular surgery, eye troma, congenital pupil anomalies and those with the history of headache and allergy to the eye drop will be excluded from the study.
The Impact of Covid-19 on Patients Waiting for Knee Surgery

The Covid-19 pandemic has led to the postponement and cancellation of elective orthopaedic surgeries worldwide. These delays to elective procedures combined with ongoing demand have led to increasingly longer waiting list times.

This cross-sectional pilot study aims to investigate the change in patients' perceptions of knee pain and function since being waitlisted for surgery. A bespoke survey will be administered to eligible patients over the phone from Trafford General Hospital, Manchester. The survey will also investigate the coping mechanisms and the preventative measures patients are taking to manage symptoms during the pandemic, and question what kinds of communication and support patient would like to be offered whilst waiting for treatment.

This study will improve clinicians' and researchers' understanding of how patients are coping with symptoms during this pandemic, and provide information on how to better support patients who are waiting for knee surgery. This information could be used to enhance orthopaedic care during, and in the aftermath, of this pandemic. The information gathered in this study may also be used to inform a larger multi-centre study.


Eligibility Criteria:
Inclusion Criteria:

* Patients identified by a consultant orthopaedic surgeon as being on a waiting list for surgery on their knee.
* Patients identified by a consultant orthopaedic surgeon who are experiencing a delay to their knee surgery as a result of the COVID-19 pandemic.
* Patients over 18 years old.

Exclusion Criteria:

* Patients who are no longer waiting for their surgery (e.g. surgery performed elsewhere or patient has changed their mind about undergoing surgery).
* Patients who are on a waiting list for any surgery other than surgery of the knee.
* Patients who are on a waiting list for surgery at a hospital which is not a part of Manchester University NHS Foundation Trust.
* Patients who cannot read and speak English.
* Patients who cannot complete the survey over the phone.
* Patients who cannot give informed consent due to cognitive impairment (e.g. dementia or similar cognitive condition).
Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery

In the everyday clinical practice the incidence of minor complications is approximately 15-20% of the total number of third molar removals. Alveolitis (dry socket syndrome) may arise in 30-40% of the surgical tooth removals. Several preventive approaches are known, such as the use of iodoform gauze, zink-oxide eugenol paste, platelet rich fibrin (PRF), different medicine containing pastes, like antibiotics containing, non-steroid pain killer containing, steroid containing, or the application of chlorhexidine gel and solutions. In the case of a manifest alveolitis these methods can be used as well. The aims of this research are: i) to identify the important pathogens which play role in the development of alveolitis (microbiological methods), ii) to analyze the in vitro effectivity of the different antiseptic materials in case of infections (inhibitory zones) iii) to compare the effectivity of different alveolitis preventive methods in a prospective clinical study, iv) to compare the different treatment options in alveolitis in a prospective clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Pell-Gregory II/B impaction
* mesioangular impactions
* tooth sectioning is not necessary for removal
* without local infection of third molar

Exclusion Criteria:

* no general diseases or following treatments (DM, steroids, bleeding risk, chemotherapy, radiotherapy, bisphosphonates, immunosuppressive conditions)
Reproductive Outcomes After Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.

This research project explores how the source of sperm affects outcomes in assisted reproductive technologies (ART), focusing on children conceived through intracytoplasmic sperm injection (ICSI) with surgically retrieved sperm (SRS). Outcomes will be compared to those from ICSI with ejaculated sperm and conventional IVF. Using national registry data from all IVF and ICSI treatments in Sweden between 2007 and 2023 (Q-IVF), the study applies artificial intelligence (AI) and machine learning (ML) to identify factors influencing success rates. The aim is to improve prediction models and support more personalized fertility treatments. Special emphasis is placed on understanding the potential risks and long-term health outcomes for children conceived using SRS, which may be associated with higher rates of genetic abnormalities. The results may help optimize care strategies for infertile couples.

This research project aims to improve our understanding of how different sources of sperm affect outcomes in assisted reproductive technologies (ART). The focus is on children conceived through intracytoplasmic sperm injection (ICSI) using surgically retrieved sperm (SRS), compared to ICSI with ejaculated sperm and conventional in vitro fertilization (IVF).

The study has three main goals:

1. To compare reproductive outcomes following ICSI with SRS, ICSI with ejaculated sperm, and conventional IVF.
2. To investigate whether artificial intelligence (AI) and machine learning (ML) algorithms can predict cumulative reproductive outcomes, including results from both fresh and frozen embryo transfer cycles.
3. To evaluate how AI/ML-based models perform in comparison to traditional statistical methods in terms of accuracy and predictive value.

Method: National Population-Based Registry Study: This includes all IVF and ICSI treatments performed in Sweden from January 1, 2007, to December 31, 2023, using data from the Swedish National Quality Registry for Assisted Reproduction (Q-IVF). AI will be used to analyze large datasets, detect patterns, and help identify key factors-such as sperm source, number of retrieved oocytes, and patient characteristics-that may influence treatment success. This approach could lead to personalized treatment plans and better predictions of successful pregnancy outcomes.

Special attention is given to outcomes in children born after ICSI with surgically retrieved sperm, as these sperm may be less mature and carry a higher risk of genetic abnormalities. The findings are expected to provide valuable insights into the reproductive and long-term health outcomes of these treatments, ultimately helping to improve care and treatment strategies for infertile couples.

Eligibility Criteria:
Inclusion Criteria:

* All IVF treatments performed in Sweden during the study period.
* IVF treatments will be identified from the National register Q-IVF.

Exclusion Criteria:

* Children born from multiple pregnancies
* Children conceived through oocyte and sperm donation
Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer

The purpose of this study is to assess the safety and effectiveness of Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Posterior Advanced Non-small Cell Lung Cancer

This efficacy and safety research plan to explore the use of Apatinib combined with Vinorelbine to driven gene mutation negative three line and three line later non-small cell lung cancer.According to the result of TAX317,the investigators expect the effective rate is 20% and 80% of degree of assurance.Single arm bilateral experiment's sample size is calculated 27, according to 10% censoring,the expected sample size is 30.

Eligibility Criteria:
Inclusion Criteria:

* 18，Pathologically proven non small cell lung cancer

  * Adenocarcinoma，No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
  * Squamous cell carcinoma，no gene detection
  * Progress after second line
  * PS score \>2

Exclusion Criteria:

* Patients received apatinib or Vinorelbine treatment before
* EGFR, ALK or ROS1 mutation
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women