cyrilzakka/clinical-trials huggingface dataset:
Analgesia After Cesarean Section

Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an effective as an analgesic adjuvant. The investigators evaluated the analgesic effect of magnesium in parturients undergoing Cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* parturients undergoing Cesarean section
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females


Eligibility Criteria:
Inclusion Criteria:

* Virginal Female Subject Aged 9 To 17 Years

Exclusion Criteria:

* Male Subject
Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion in Cancer Patients

There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have immunomodulatory effects. The aim of this randomized single-center trial is to compare immune responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC) or a leuko-reduced RBC (LR-RBC) transfusion perioperatively.

This single-center study is conducted to compare the effect of peroperative transfusion of allogeneic unmodified RBC (UN-RBC) versus leuko-reduced RBC (RED-RBC) on recipient immunity. Patients undergoing cancer surgery are randomly assigned peroperatively to receive UN-RBC or RED-RBC. Groups are stratified for age, sex, tumor characteristics, prior transfusion and prior cancer treatment. Blood sampless are collected before anesthesia (d0) and at days 3, 7, 14 , 28 after transfusion/surgery and analyzed for complete cell blood count, lymphocyte subsets, cytokine production (IL4, IL10, IFNgamma, IL12), T-cells repertoire (TCR) analysis and detection of circulating donor cells. Main study endpoint is the influence of the treatment arm on IL4/IFNgamma ratio. The effect of transfusion type on any given biological parameters is also tested (peripheral blood mononuclear cell phenotyping (PBMC), cytokine production by stimulated PBMC, T cell repertoire analysis and microchimerism assessment).

Eligibility Criteria:
Inclusion Criteria:

* Surgery for cancer with a transfusion during surgery risk greater than 30%
* Surgery in curative intent
* Written informed consent

Exclusion Criteria:

* contraindications to the use of allogeneic unmodified red blood cell concentrate
* any anti-RBC and/or anti-HLA and/or anti-granulocyte alloimmunization
Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Endometriomas

Endometriosis is a benign chronic gynaecological disease that affects 10% of women of reproductive age and takes 40% of them to assisted reproduction techniques.

The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular count (AFC) , with the most common serological markers of ovarian reserve. The investigators intend to confirm their clinical utility in the assessment of ovarian function, and to promote their use in predicting decreased ovarian reserve.

The work therefore moreover arises the objective to validate the bibliographic data about using the laser for haemostasis after stripping endometriomas, to amplify knowledge available in the literature on the surgical treatment of ovarian endometriomas and on the diode laser application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the possible surgical implications on fertility .


Eligibility Criteria:
Inclusion Criteria:

* regular menstrual cycles
* unilateral endometrioma greater than 35 mm
* no gynecological surgery 3-6 months before surgery
* no hormonal therapy 1 month before surgery

Exclusion Criteria:

* previous surgery for endometriosis
* hormone therapy in the month before the current surgery
* coagulation disorders
* ongoing pregnancy
* pelvic inflammatory disease
* malignant disorders
* cysts otherwise
* Gonadotropin-releasing hormone analogues or contraceptive therapy during the follow-up
* BMI≥ 30 kg/m2
* endocrinological disorders
* unable or unwilling to give written consent
A Geriatric Oncology Collaborative Care Intervention for Older Adults With Advanced Cancer

The purpose of this research study is to develop a geriatric oncology collaborative care intervention to enhance the quality of life, symptom burden, and functional outcomes of older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancers.

Cancer disproportionately affects older adults, and the number of older adults with cancer is expected to grow as the population ages. Older adults with advanced cancer often possess a distinct set of medical and psycho-social issues that makes caring for the geriatric oncology population challenging for oncologists. Currently, a critical knowledge gap exists regarding how best to deliver comprehensive cancer care targeting the unique geriatric and palliative care needs of these individuals. The investigators propose to develop a geriatric oncology collaborative care intervention to improve supportive care outcomes for older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancer. GI and GU cancers are among the leading causes of cancer death in the geriatric cancer population, and patients with advanced GI and GU cancers experience a high symptom burden. The intervention will entail visits with an oncology advanced practice nurse trained to address patients' unique needs, who will meet regularly with a supervising team of geriatric, palliative care, social work, and pharmacy clinicians for feedback and iterative reevaluation of the care plan. Using nurses who are already integrated into the oncology setting represents a scalable model that addresses the workforce shortage of geriatric and palliative care clinicians. The investigators used conceptual models for collaborative care and geriatric interventions to develop an initial intervention framework, and prior research to develop a preliminary intervention manual. In Aim 1, the investigators will refine and finalize both the intervention and the intervention manual based on qualitative data from patients, caregivers, and clinicians to ensure the intervention targets the unique needs of older adults with advanced cancer. In Aim 2, the investigators will modify the intervention and study methods with an open pilot study (n=10). In Aim 3, the investigators will conduct a pilot randomized trial (n=75) to assess the feasibility and preliminary efficacy of the geriatric oncology collaborative care intervention for improving patients' QOL, symptom burden, and functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* Diagnosed with advanced (defined as metastatic or receiving therapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, renal, bladder, or prostate cancer within the past 8 weeks (includes patients with a new diagnosis, progression or recurrence).
* ECOG performance status of 0-2
* Ability to read and respond to questions in English
* Planning to receive care at MGH

Exclusion Criteria:

- Uncontrolled psychiatric illness or impaired cognition
Endovascular Treatment for eXtra-Large Ischemic Stroke

The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Several randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, six randomized controlled trials demonstrated the efficacy and safety of endovascular thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] ≥3 or infarct core \<100ml). Patients with extra-large infarct core (volume greater than 100 mL, ASPECTS score of 0 to 2) accounted for a small proportion of these trials. Therefore, the role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. That is to say, exactly where the lower limit of endovascular thrombectomy is unknown. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
2. Acute ischemic stroke within 6 hours from last known well to randomization, or with negative MRI-FLAIR (no change on FLAIR sequence and presence of infarct on MRI-DWI) if \> 6 hours or unknown last known well time;
3. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
4. Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
5. The patient or patient's representative signs a written informed consent form.

Exclusion Criteria:

1. CT or MR evidence of hemorrhage;
2. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
3. Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
4. History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
5. Currently participating in another investigational drug study;
6. Any terminal illness with life expectancy less than 6 months.
Measurement of Pulse Wave Velocity

Optically-based data will be compared to tonometry to determine correlation of pulse wave velocity measurement.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of18-25 and 65-90 will be studied.
* Normotensive and hypertensive subjects
* Willing to provide informed consent

Exclusion Criteria:

* has finger deformities or amputations that will prohibit proper sensor placement
* pregnant or actively trying to get pregnant
* Cardiogreen or other intravascular/tissue dyes less than 5 hours prior to the study.
Artificial Intelligence/Computer Guided Ridge Splitting for Treating Horizontal Ridge Defects

Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided ridge splitting approach assisted by artificial intelligence versus conventional approach combined with simultaneous implant Placement.

Ridge split technique is considered one of the successful horizontal bone augmentation procedures especially in maxilla for the management of horizontal ridge defects. This was adapted by Summers in 1994.

Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.

Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.

Eligibility Criteria:
Inclusion Criteria:

* The target population with inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges.
* Age ranges from 25-40 years of both sexes.
* No gender restrictions were considered for initial screening.
* Absence of any complicating systemic condition that may contraindicate surgical procedures and implant placement.
* Adequate oral hygiene.
* Eligible participants should present good general health and agree to random assignment to any of the two parallel study groups.
* Participants had minimum 3 months as post extraction healing period and horizontal maxillary anterior ridge defects with at least bone width of 3 mm and bone height of 13 mm.

Exclusion Criteria:

* Vertical ridge defect.
* Undercut on the labial/buccal side.
* Thick cortical bone without cancellous bone inside.
* Uncontrolled systematic disorders as, diabetes mellitus, uncontrolled periodontal disease, history of head and neck radiotherapy, smokers, pregnancy, noncompliant patients, allergy to the used medications, uncooperative individuals or those unable to attend the study follow-up appointments.
Efficacy of Antiviral Therapy in Pregnancy in Preventing Vertical Transmission of HBV in Mothers With a High Viral Load

Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV) infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg positive mothers with high serum HBV DNA loads.

This study contain 600 patients and compose groups as follow: (ⅰ) infants born to a HBsAg positive mothers with high HBV DNA load before delivery receive standard immunoprophylaxis( injection of HBIG 200IU at birth plus HBV vaccine at 0,1 and 6month); (ⅱ) infants born to a HBsAg positive mother with high HBV DNA load before delivery, and based on standard immunoprophylaxis receive addition injection of HBIG 200IU at 1 month after birth; (ⅲ) infants born to a HBsAg positive and high HBV DNA load mothers but treated with antiviral therapy in late pregnancy, receive standard immunoprophylaxis; (ⅳ) infants born to a HBsAg positive mothers treated with antiviral therapy during entire pregnancy for hepatitis receive standard immunoprophylaxis; (ⅴ) infants born to a HBsAg positive mother with serum HBV DNA negative receive standard immunoprophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* infants born to HBsAg positive mother HBsAg positive mother

Exclusion Criteria:

* mothers coinfected HIV or HCV
The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.

This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.

There will be approximately 50 eyes with two groups:

Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.

Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD.

Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible for study participation if they:

  1. Are an adult subject aged 65 years or older
  2. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes
  3. Are willing and able to comply with clinic visits and study related procedures
  4. Are willing and able to sign the informed consent form

Exclusion Criteria:

* Subjects are not eligible for study participation if they:

  1. Have active infectious systemic disease
  2. Have active infectious ocular or extraocular disease
  3. Have unobstructed nasolacrimal duct in the study eye(s)
  4. Have known hypersensitivity to dexamethasone or are a known steroid responder
  5. Have a history of ocular inflammation or macular edema
  6. Are currently being treated with immunomodulating agents in the study eye(s)
  7. Are currently being treated with immunosuppressants and/or oral steroids
  8. Are currently being treated with corticosteroid implant (i.e. Ozurdex)
  9. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
  10. Have a history of complete punctal occlusion in one or both punctum
  11. Currently use topical ophthalmic steroid medications
  12. Are unwilling or unable to comply with the study protocol
  13. Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty

The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.

This is a randomized, double-blind, placebo-controlled, one-time application study of DMTS or matching placebo over a 4-day treatment period (Day 1 Time 0 occurs when the DMTS or matching placebo systems have been applied). Subjects scheduled for an abdominoplasty will be screened up to 28 days prior to surgery. Eligible subjects will be randomized equally to treatment with DMTS or matching placebo. An independent safety monitoring committee will periodically review unblinded safety data to confirm the safety/tolerability of the dose or recommend a dose reduction.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥ 18 years of age.
* Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias, but not including liposuction).
* Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
* Have a body weight \> 58 kg, and body mass index of 20 to 38 kg/m2, inclusive.

Exclusion Criteria:

* Known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo or to any peri- or postoperative medication whose use is required in this study.
* Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
* History of deep vein thrombosis or factor V Leiden deficiency.
* History of syncope or other syncopal attacks.
* Present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator.
* Evidence of a clinically significant 12-lead ECG abnormality.
Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)

The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe, with ABI \< 0.6 or/and TBI \< 0.4
2. Rutherford category 4-5
3. Non candidate for revascularization or endovascular intervention based on unfavorable vascular anatomy or significant co-morbid medical conditions as confirmed by vascular study (e.g., angiogram, MRA) obtained within 3 months prior screening visit and signed approval of vascular surgeon. The decision to classify the subject as a non-candidate will be made by the investigator and confirmed by an independent third party vascular surgeon who is not participating in the study.
4. In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.
5. Those diabetic subjects who are on optimal diabetes medication, with an HbA1c \< 8%

Exclusion Criteria:

1. Uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg during screening).
2. Wounds with severity greater than Grade 2 on the Wagner Scale
3. Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged.
4. ST segment elevation myocardial infarction and/or TIA/CVA within six (6) months prior to enrollment.Patients with severe congestive heart failure (i.e. NYHA Stage IV)
5. In the opinion of the investigator, the patient is unsuitable for cellular therapy.
Monitoring Response to Antiplatelet Therapy

Antiplatelet therapy plays a key role in the prevention of complications related to coronary angioplasty and stenting (PCI) including procedure related myocardial damage. Aspirin and clopidogrel are now universally prescribed in patients undergoing these procedures. However, loading and maintenance doses have not been established and variation in individual response is emerging. New tests to assess the effects of these drugs are being developed but have yet to be incorporated into routine clinical practice. We will assess the effects of aspirin and clopidogrel in a consecutive series of patients undergoing angioplasty using new assays which can be carried out at the bedside. We will compare the results with alternative laboratory based tests and look for an association between the results, peri-procedural myocardial necrosis and subsequent cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18-80 undergoing intended PCI for conventional indications. Informed written consent.

Exclusion Criteria:

Administration of GPIIbIIIa therapy prior to PCI, Oral anticoagulation, ticlopidine, dipyridamole, NSAID therapy, Pregnancy, Troponin I \>0.2mcg/l on day of procedure, Chest pain in the 24 hrs prior to PCI. Anaemia (Hb\<10g/dl). Platelet Count \<150 or \>450 x10\^9/l, Personal or family history of bleeding disorder.