cyrilzakka/clinical-trials huggingface dataset:
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

The purpose of this study is to continue evaluating how well the RSV vaccines work as they are currently being used in routine clinical practice. Some of the questions that the investigators hope to answer with this study are: 1) What is the overall effectiveness of these vaccines? 2) How long does immunity last? 3) How effective are the vaccines against new strains? 3) Does the vaccine's effectiveness vary by age?

This will be a large-scale case-control study aiming to evaluate the effectiveness of perinatal RSV immunoprophylaxis. Cases and controls will be identified using active surveillance in both inpatient and outpatient clinical sites of the Yale New Haven Health System. Investigators will enroll patients seeking health care for acute respiratory illness and confirm RSV infection using approved molecular assays. Data will be collected from multiple sources, including health records, interviews, immunization registries, and population-based surveys. Investigators will generate estimates of effectiveness for each type of immunization used, disaggregated by time from immunization, disease severity, and sociodemographic characteristics (Aim 1). Investigators will also perform genetic characterization of all RSV viruses in the study, monitor the genetic diversity of the virus over time, and quantify the relative effectiveness of immunoprophylaxis against various viral lineages (Aim 2). Finally, investigators will collect acute and convalescent blood from a subset of infants and employ a single-cell and multi-omics approach to study the dynamics of the innate and adaptive immune responses during RSV infection and explore the molecular mechanisms that contribute to immunoprophylaxis failure (Aim 3).

Eligibility Criteria:
Inclusion Criteria:

* ≤ 12 months of age at the time of presentation for evaluation for an acute respiratory infection (ARI).
* Documentation of an ARI, which is defined as an acute onset (\<10 days) illness that includes: At least two of the following symptoms: fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, nausea or vomiting, diarrhea, fatigue, congestion OR any one of the following: cough, shortness of breath, difficulty breathing, olfactory disorder, taste disorder, confusion, persistent chest pain, pale, gray, hypoxia, clinical or radiographic evidence of pneumonia or respiratory distress syndrome.
* Residents of Connecticut

Exclusion Criteria:

* Illness duration of \>10 days at the time of respiratory specimen collection, measured from the date of the first symptom of the current acute illness.
* Parents/guardians are not able to provide informed consent

To be eligible for inclusion in the study as a healthy control, an individual must meet all of the following criteria:

* Immunized against RSV ≤ 12 months of age
* Residents of Connecticut
* Match an enrolled case that was a vaccine failure by date of birth (±1 month), sex, and immunoprophylactic agent received (i.e., maternal vaccine vs mAb).
Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.

This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial endovascular intervention.

This study is a multicentre, parallel-group, prospective, randomized open-label, blinded-endpoint adjudication, proof-of-concept, and exploratory trial. Two hundred patients will be randomized in a 1:1 ratio, 72 hours after successful infrapopliteal angioplasty for critical limb ischemia. In the study group, patients will receive oral apixaban 2.5mg twice daily plus aspirin 100 mg once-daily for 12 months. In the control group, aspirin 100 mg once-daily will be taken for 1 year on a background of clopidogrel (75mg daily) for the first three months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation or restenosis/occlusion (RAS) plus MACE (myocardial infarction, stroke, and cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding and clinically relevant non-major bleeding at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Age\>18 years old.
* Negative serum pregnancy test (in women of childbearing only).
* Patients submitted to endovascular procedures below-the-knee by not exclusively.
* Patient understands and is willing and able to comply with the study instructions and follow-up visit.
* More than 70% stenosis or occlusion of the three distal arteries including or not the tibiofibular trunk (TFT).
* Tissue loss (Rutherford 5).
* One or more patent vessel of pedal arch.

Exclusion Criteria:

* TASC II D femoral and/or popliteal occlusion.
* Life expectancy less than 1 year.
* Allergy or contraindication to apixaban treatment.
* Allergy or contraindication to dual antiplatelet treatment.
* Creatinine clearance less than 30mL/min.
* Planned major amputation before procedure.
* Hybrid procedure (open and endovascular).
* Use of fibrinolytic in the past 10 days.
* Known HIV infection.
* Liver disease (acute or chronic hepatitis and cirrhosis).
* Drug addiction or alcohol abuse 12 months before the randomization.
* Concomitant medications thatinhibit the CYP 3A4 cytochrome and P glycoprotein (ketoconazole, Iitraconazole, ritonavir).
* Platelets count inferior to 100x109/L.
* INR more than 1.5.
* History or condition with high risk of bleeding: Eg. Trauma within 30 days before randomization, gastrointestinal bleeding 6 month before the randomization, intra-ocular, spinal, intra-articular bleeding (any time before), AV malformation, cerebral aneurysm and hypertension without control.
Mass-balance Study of [14C]-APD421 in Healthy Volunteers

Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Age 18 to 65 years of age at time of signing informed consent
* Body mass index (BMI) of 18 to 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator
* Must be willing and able to communicate and participate in the whole study
* Must provide written informed consent
* Must agree to use an adequate method of contraception (as defined in Section 8.4)
* Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)

Exclusion Criteria:

* Prior participation in another study with a radiation burden of \> 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of \> 1 mSv and ≤ 2 mSv in the period of 2 years prior to screening; a radiation burden of \> 2 mSv and ≤ 3 mSv in the period of 3 years prior to screening, etc (add 1 year per 1 mSv)
Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study

This study aims to compare scar outcomes between rapidly absorbable and non-absorbable sutures (stitches) for the closure of wounds after skin cancer removal on the face.


Eligibility Criteria:
Inclusion Criteria:

* Mohs surgical wound on the face
* Wound greater than or equal to 4 cm in length
* Subject is willing and capable of cooperating to the extent and degree required by the protocol and will be able to come for follow-up assessments
* Subject has read and signed Subject Information and Informed Consent Form

Exclusion Criteria:

* Surgical wound less than 4 cm in length
* Surgical site outside of face
* Subject to be be treated with radiation therapy after surgery
* Subject is not willing or able to attend for follow-up assessments
CHOICE to AVOID or RESIST

This trials will formally test whether participants' active choice of self-regulatory strategies (AVOID or RESIST) leads to greater adherence to weight management strategies by comparing the CHOICE arms to the randomized arms of the parent intervention, AVOID/RESIST (IRB STUDY00001652: AVOID-RESIST).

Since we initiated recruitment for the AVOID/RESIST trial (IRB STUDY00001652: AVOID-RESIST), we have noted that some participants have a strong initial inclination for one of the self-regulatory strategies. Some individuals have clearly expressed which strategy they believed would work for them, while others have voiced dislike or skepticism for an assigned intervention component. While attrition in the last 18 months (12.5%) is comparable to trials of similar size and scope, over 56% (n=18) of withdrawals were explicitly (n=3) or tangentially (n=15) related to intervention assignment.

This pilot study (CHOICE) seeks to leverage our ongoing R01 to test whether participants' active choice of behavior change pathways and strategies leads to better adherence, retention, and engagement. Consistent with ongoing procedures, women, and men with overweight or obesity (BMI between 25-45 kg/m2) will be enrolled in the WW digital program for 12 months. R01 participants will continue to be randomized to one of the 4 study arms: (1) WW alone, (2) WW + AVOID, (3) WW + RESIST, (4) WW + AVOID + RESIST. CHOICE participants will be asked to choose which self-regulatory strategy (AVOID or RESIST) they want to receive to promote behavior change consistent with WW recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* BMI between 25-45 kg/m2
* Read, write, and speak English with acceptable visual acuity

Exclusion Criteria:

* Currently enrolled in weight loss interventions or undergoing bariatric surgery
* Pregnant women
* Individuals for whom weight loss may be contraindicated (e.g., unstable coronary artery disease, end-stage disease, active cancer treatment, uncontrolled insulin-dependent diabetes, portal hypertension, drug/alcohol abuse)
* Individuals who have pacemakers or other electronic medical device implantations
* Individuals with severe cognitive delays or visual/hearing impairment
* Individuals who are unable or unwilling to complete the study assessments / measurements
* Individuals currently subscribed to a meal delivery service who are unwilling to pause their subscription for the duration of the study
A Study of OPC-262 in Patients With Type 2 Diabetes

The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in patients with type 2 diabetes by repeated administration orally for 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes patients with HbA1C above 6.5% and below 10% at both of the time of the 1st and the 2nd screening examinations and who have been undergoing diet and exercise therapies only for at least 8 weeks prior to the 1st screening examination
2. Patients who are capable of giving informed consent
3. Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion Criteria:

1. Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
2. Patients with a medical history of diabetic coma
3. Patients with poorly-controlled hypertension
4. Patients with heart failure
5. Patients with a complication of active hepatitis or hepatic cirrhosis
6. Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
7. Patients with a history or complication of malignant tumor
rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors

The study evaluates the efficacy and safety of a prophylactic treatment with recombinant activated FVII in reducing the frequency of joint bleeds and the development of joint damage in children with hemophilia A who develop high-titer inhibitors.

This is a multicentre, randomised, controlled study designed to gain evidence of the advantage of the prophylactic, daily treatment with recombinant activated FVII as compared to the conventional on demand therapy in reducing the bleeding frequency and preserving the orthopaedic status in hemophilic children with inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia A who have been treated with factor VIII on demand or on prophylaxis and who have developed inhibitors to factor VIII
* ≤ 2 years from the time of first inhibitor detection.
* High-responding inhibitors (historical peak \> 5 BU/mL)and known anamnestic response in case of negative inhibitor titre.
* Candidates to start daily ITI with FVIII doses ranging from 50 IU/Kg/day to 200 IU/Kg/day
* Maximal two bleedings in the same joint within the last 6 months before entering the study or maximal six joint bleeds in the same joint within 2 years
* Adequate venous access for daily infusion and capable (caregiver) of reconstituting and injecting the study drug
* Informed consent by parents or legal guardians.

Exclusion Criteria:

* ITI already started
* Known or suspected hypersensitivity to the active substance or to any of the excipients of the study drug
* Administration of any investigational product within 30 days prior to randomisation
* Other coagulation disorders than congenital hemophilia A.
* Family history of thrombosis at an early age (\< 40 years), known thrombophilia, any previous thrombosis including catheter-related deep vein thrombosis, previous neonatal thrombosis.
* Known pseudo tumours
* Known severe liver disease
* Platelet count \< 50,000 platelets/µL at screening
* Surgery within one month or planned major and/or orthopaedic surgery.
Reconstruction of the Pelvic Floor After Total Pelvic Exenteration Using the TMG Flap

Total pelvic exenteration (TPE) is a rare operation, which is the only possible curative intervention to treat central residual or recurrent tumors of the vulvar, vaginal, cervical, or uterine malignancies after initial surgery, radiation therapy and chemotherapy. Several options for pelvic floor and vaginal reconstruction have been described. The transverse musculocutaneous gracilis (TMG) flap has been introduced for breast reconstruction as a free flap. The investigators adopted the pedicled TMG flap for reconstruction after TPE.

Between November 2011 and February 2014, twelve patients underwent TPE and reconstruction with unilateral (6 patients) or bilateral (6 patients) pedicled TMG flaps. Five patients had vaginal reconstruction with bilateral TMG flaps. The investigators describe the operative procedure and the outcome of the operation in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the department of Gynecology in the University hospital of Tampere, who underwent total pelvic exenteration with reconstruction of the pelvic floor.

Exclusion Criteria:

-
Tolerability and Quality of Life Study in Participants Who Switched to Avonex Pen

To evaluate treatment tolerability, adherence and quality of life (QoL) over 1 year in MS (Multiple Sclerosis) participants who have been switched - due to persistent tolerability issues, particularly injection problems - from a subcutaneous injectable disease-modifying treatment (DMT) given several times a week (Rebif, Betaferon or Copaxone) to once weekly Avonex 30 μg given intra-muscularly. Avonex will be applied by the injection device Avonex Pen.


Eligibility Criteria:
Key Inclusion Criteria:

* Continuous treatment with Rebif, Betaferon or Copaxone over at least the past year.
* Injections site tolerability issues documented in medical records or by a nurse at inclusion.
* Clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on therapy.
* Documented neurological history at least for the year prior to study entry.
* Qualification for Avonex® (Avonex Pen) according to the approved indication (Clinical Isolated Syndrome) or Relapsing Remitting Multiple Sclerosis (RRMS).
* Acceptance of magnetic resonance imaging.

Key Exclusion Criteria:

* Patients who have previously entered this study.
* Treatment with Avonex during the 12 months prior to the study.
* One or more relapses and/or 6-month confirmed disability progression during the 6 months prior to the study.
* Patient on Betaferon with Neutralizing Antibodies (NAbs) more than 400 TRU (tenfold reduction units) and patients on Rebif with NAbs with more than 100 TRU.
* Secondary progressive multiple sclerosis.
* Primary progressive multiple sclerosis.
* Pregnancy or breast feeding.
* History of severe depression or attempted suicide or current suicidal ideation.
* Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study.
* Uncontrolled seizure disorder.
* Myopathy or clinically significant liver disease.
* Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study.
* Known hypersensitivity to interferon-beta or other human proteins including albumin.
* A history of drug abuse in the 6 months prior to screening.
* Treatment with any of the following in the 30 days before day 1: systemic corticosteroids, ACTH, or other investigational drugs.
* Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.


Eligibility Criteria:
Inclusion Criteria:

* Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant
* If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

* Recipients of a kidney from a donor over 65 years of age
* Recipient of non-related donor kidney with peak pre-transplant PRA \> 50
* Subject has lost a previous graft to rejection less than one year from transplant
* Subject who has received an investigational drug within three months prior to randomization
* Subjects who are pregnant or breastfeeding
* Subject receives a kidney lacking a pre-implantation biopsy
* Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol
A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India

The purpose of this study is to assess the safety and efficacy of nivolumab combined with ipilimumab in intermediate and poor-risk participants with previously untreated advanced renal cell carcinoma (RCC) or metastatic RCC (mRCC) in India.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may have sarcomatoid features
* Qualifies as intermediate or poor risk by meeting at least one of the prognostic factors as per the International Metastatic RCC Database Consortium (IMDC) criteria
* Indian participants with Indian ethnicity living in India
* No prior systemic therapy for RCC
* Measurable disease lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Exclusion Criteria:

* Participants with active, untreated, symptomatic central nervous system (CNS) metastases
* Major surgery less than 28 days prior to the first dose of study treatment
* Participants with an autoimmune disease, or any other condition, requiring systemic treatment with either corticosteroids or other immunosuppressive medications

Other protocol-defined inclusion/exclusion criteria apply
Breastfeeding Education Support Tool

The proposed project seeks to evaluate the effectiveness and implementation of the Breastfeeding Education Support Tool for Baby (BEST4Baby) intervention, an mHealth-supported community-based peer counselor breastfeeding intervention for mothers in India. Given that rates of optimal infant feeding practices have remained stagnant over the past two decades in India, and that India is the most populous country and icontributes one-fifth of all global live births, this project could have major global health implications if the intervention is found to improve maternal breastfeeding practices and infant clinical outcomes. The project will also provide evidence needed to adopt BEST4Baby nationally and in other low resource communities.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age,
* pregnant and 20-27 weeks of gestation at study enrollment,
* singleton pregnancy,
* no major antepartum complications,
* living in a research site,
* planning to deliver in the cluster area,
* capable of giving informed consent,
* willing to be visited by a PC and research personnel for up to 12 months post-delivery.

Exclusion Criteria:

comorbidities impacting breastfeeding,

- severe psychological illness that could interfere with consent and study participation. Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences: illness or clinical complications warranting prolonged hospitalization, stillbirth, low birth weight (\< 2500 g), congenital abnormality, or neonatal death.