cyrilzakka/clinical-trials huggingface dataset:
Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

In sub-Saharan Africa, cervical cancer is the leading cause of cancer death among women because of the difficulty in implementing screening programs. The main obstacles in these countries are poverty, lack of healthcare infrastructures and trained practitioners. With the availability of new technologies, researchers are looking for new strategies adapted to low- and middle-income countries to identify cervical precancerous lesions.

Current evidence shows that Human Papilloma Virus (HPV) testing is more effective than cytology (Pap smear) for cervical cancer screening in resource-limited settings. Indeed, the GeneXpert® HPV test offers the opportunity to prevent cervical cancer (CC) in a single visit: rapid detection of high-risk HPV (HPV) infection followed by same day treatment of HPV-positive women during the same visit (screen-and-treat approach).

However only a small proportion of HPV-positive women will develop cervical (pre)cancer, making it important to select those to treat. This triage can be achieved by colposcopy, cytology and visual inspection after application of acetic acid (VIA). Though VIA is the triage test recommended by WHO for resource-limited countries, it has not yet been widely assessed in sub-Saharan Africa (SSA).

The main objective of the investigators is to assess the performance of HPV-test followed by Visual Inspection after application of Acetic acid and Lugol's iodine VIA/VILI to detect cervical precancerous lesions in a screen-and-treat strategy in Cameroon (sub-Saharan Africa) where there is no cervical cancer-screening program.

The investigators organized a successful free screening campaign in Cameroon in 2015 that allowed to identify the expectations of women and their eagerness to benefit from prevention of gynecological cancers and sexually transmitted diseases.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 30-49 years, able to comply with the study protocol

Exclusion Criteria:

* Pregnancy
* Previous total hysterectomy
* Conditions impairing examination of the cervix
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases

The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy, membranous nephropathy, lupus-related kidney disease (lupus nephritis). or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis to determine if povetacicept is safe and potentially beneficial in treating these diseases.

During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52 week treatment extension period .


Eligibility Criteria:
Key Inclusion Criteria Summary:

1. Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN) 2.

Indication-specific criteria:

a. IgAN

* Biopsy-confirmed diagnosis less than or equal to (≤)10 years prior to the start of screening AND Screening UPCR greater than or equal to (≥)0.5 g/g.
* No background immunosuppression therapies.

pMN

* A historical biopsy-confirmed diagnosis with positive anti-PLA2R1 antibodies or anti-THSD7A antibodies at screening AND Screening UPCR ≥1 g/g
* Inadequate reduction of proteinuria determined by the Principal Investigator (PI) despite optimal supportive care for at least 12 weeks.
* No background immunosuppression therapies except for optional calcineurin inhibitors.

LN

* A Biopsy-confirmed diagnosis of active, proliferative Class III, IV, (with or without Class V) LN ≤6 months prior to the start of screening AND
* Screening UPCR ≥1 g/g,
* Positive anti-dsDNA at screening
* On stable background immunosuppression ≥ 8 weeks prior to Day 1

AAV

•

Past diagnosis of renal AAV, defined as either of the following:

* History of renal biopsy consistent with renal AAV.
* History of clinically diagnosed renal AAV.
* Myeloperoxidase (MPO)-ANCA or proteinase 3 (PR3)-ANCA positive by enzyme-linked immunosorbent assay at screening.
* At least 4 weeks since initiation of AAV induction therapy, if applicable.

  3. On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1

Key Exclusion Criteria Summary:

1. Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease
2. eGFR \<30 (milliliter per minute per square meter (mL/min/1.73m\^2) or rapidly progressive glomerulonephritis
3. Recent serious or ongoing infection; risk or history of serious infection
4. Receipt of B cell depleting therapies or anti-BAFFand/or APRIL therapies within protocol specified timeframes
Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies

The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.


Eligibility Criteria:
1. Currently participating or participated recently in a BeiGene parent study
2. Intent to continue or start zanubrutinib treatment after any of the following:

   1. At time of final analysis or study closure of the eligible BeiGene parent study
   2. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
   3. At an alternative timepoint for an alternative reason
3. Patient who is currently on zanubrutinib treatment:

   Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment
4. Zanubrutinib-naive patient:

   Must meet the following criteria ≤ 15 days before first dose of study drug:
   1. Platelets ≥ 50,000/mm3
   2. Absolute neutrophil count ≥ 750/mm3
   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
   4. Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome)
   5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
   6. No known New York Heart Association (NYHA) Class III or IV congestive heart failure
   7. Creatinine clearance ≥ 30 mL/min
5. Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.

Key Exclusion Criteria:

1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent
2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
3. Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk
4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
5. Pregnant or lactating woman
6. Inability to comply with study procedures
7. Concurrent participation in another therapeutic clinical study
8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Ruxolitinib in Combination With Autotransplant

To determine the safety of the approach of giving RUXOLITINIB before and after an autologous stem cell transplant, as measured by graft failure or death.

This is a pilot, single arm, single center study with no stratification to assess the safety (measured by graft failure or death) and feasibility (measured by adequacy of stem cell collection) of combining ruxolitinib with autologous Hematopoeitic Stem Cell Transplantation (HSCT) in patients with advanced myelofibrosis (MF). Patients will receive a short course of ruxolitinib prior to and during mobilization of HSCT with Filgrastim. Conditioning for the autologous HSCT will consist of Bulsulfan. Post-transplant patients will receive ruxolitinib maintenance.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented diagnosis of MF (idiopathic or post PV/ET)
* Age 18-75 years
* Intermediate-2/ high-risk disease as per Dynamic IPSS (DIPSS) criteria or Intermediate-1 risk disease with one of the following features within one year from screening:

  1. Red cell transfusion dependency
  2. unfavorable Karyotype
  3. platelet count \<100 x 109/L
  4. symptomatic splenomegaly
  5. PB blasts \> 1%
  6. Blasts in PB \<20% prior to study enrollment
  7. No available suitable matched related (6/6 or 5/6) or unrelated donor (8/8 or 7/8 allele matched) or unwilling or unable to pursue allogeneic stem cell transplant
  8. WBC \<50,000/ml at screening
* Able to give informed written consent
* ECOG Performance status of 0-2
* Life expectancy \>6 months
* Off all myelofibrosis-related investigational or standard agents (except for ruxolitinib) for at least 4 weeks prior to study enrollment and recovered from all toxicities. If patient is already on ruxolitinib for a minimum of 16 weeks prior to study enrollment, patient can proceed to mobilization and collection
* Adequate organ function defined as the following (\*unless clearly disease related):

  1. Adequate renal function - creatinine \<2 x ULN
  2. Adequate hepatic function - AST/ALT \<3 x ULN, Total Bilirubin \<3 x ULN, exception is elevated indirect bilirubin attributed to Gilbert's syndrome or hemolysis
  3. Adequate hematopoietic function - Platelet ≥50 x 109/L (without transfusion) and ANC ≥1.0 x 109/L
  4. LVEF \>40% (MUGA or echocardiogram)
  5. Adequate pulmonary function with DLCO \>40%

Exclusion Criteria:

* Hypersensitivity to JAK inhibitor
* Clinical evidence of cirrhosis
* Leukemic transformation (\>20% blasts in PB or BM any time prior to HCT)
* Platelet count \<50 x 109/L
* Active uncontrolled infection
* History of another malignancy within 5-years of date of HCT except history of basal cell or squamous cell carcinoma of skin or PV or ET
* Known HIV positive
* Woman of childbearing potential unwilling or unable to use adequate contraception Pregnant or nursing females Known active infection with hepatitis A, B or C virus
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome

To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment.

To evaluate the performance and safety of T2769 versus Vismed® Multi.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated (obtained prior to initiating any procedures).
* Patient aged ≥18 years old.
* Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit.
* Surface Disease Index (OSDI) Score ≥ 23.
* Ocular discomfort evaluated by VAS ≥ 40 mm.

Exclusion Criteria:

* Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study).
* Severe blepharitis according to the judgment of the investigator
* Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
Contrast Enhanced Ultrasound (CEUS) in Atypical Liver Nodules in Patients With Chronic Liver Disease

The present study aims to investigate the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS classification.

This retrospective study investigates the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. All CEUS exams were performed, recorded, and analyzed by two experienced operators (\>10 years of experience with abdominal US and CEUS). Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS (LR) classification. If the analyzed nodule shows a typical hallmark on CEUS (LR-5), that is arterial phase hyperenhancement with late-onset (\>60 s) washout of mild intensity, it is definitively considered HCC and have been treated appropriately. Categories LR-3 and LR-4 comprise nodules with different combinations of arterial and venous phase enhancement features, expected to correspond to an intermediate or high probability of lesions to be HCC. Patients with LR-3 or LR-4 nodules underwent follow-up; in some cases they underwent biopsy.

LR-M is used to classify high-probability malignant lesions but nonspecific for HCC; these nodules underwent biopsy for further characterization.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of liver cirrhosis or chronic liver disease with increased risk of HCC
* diagnosis of atypical nodules on contrast-enhanced CT or MRI

Exclusion Criteria:

* less than 18 years of age
* pregnancy
* typical nodules on contrast-enhanced CT or MRI
* non-visualized nodule on B-mode US
* CEUS not performed or performed more than three months after CT or MRI
Protein Requirements for Active Adolescent Males (IAAO-AM)

Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adolescents have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data.

The purpose of this study is to measure the protein requirement in adolescent, males using the IAAO technique in the presence of a variable intensity exercise stimulus.


Eligibility Criteria:
Inclusion Criteria (Adolescents):

* Healthy, active adolescent who regularly participates in moderate to vigorous physical activity 5 times a week for a minimum of 1 hour.
* Being -0.5 to +1.0 years from peak height velocity, determined by the ratio of standing to sitting height, with the maximal age for adolescents being 16 years.
* Obtaining a minimum level of 8.3 on the Beep Test

Exclusion Criteria (All Subjects):

* Inability to meet health and physical activity guidelines according to the Physical activity readiness questionnaire (PAR-Q+) and Physical Activity Questionnaire,
* an inability to adhere to any of the protocol guidelines (i.e. caffeine consumption)
* a biological age falling outside of the aforementioned ranges
Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients

Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the key target for COVID-19 infection.

DX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression under therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old; both sex;
* ECoG 0 or 1;
* Patients that would undergo biopsy or surgical operation with high ACE2 expression tumors such as colorectal cancer, renal cancer, pancreatic cancer, gastric cancer, liver cancer, lung cancer, brain cancer or suspected tumor.
* use 18F-FDG PET/CT as baseline evaluation

Exclusion Criteria:

* Significant hepatic or renal dysfunction;
* Is Pregnant or ready to pregnant;
* Cannot lie on their back for half an hour;
* Suffering from claustrophobia or other mental diseases;
* Refusal to join the clinical study;
A Study of VGL101 in Patients with Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia

This is a multicenter, open-label study to assess the safety and tolerability of iluzanebart (also referred to as VGL101) in subjects with documentation of a gene mutation in the CSF1R gene for the treatment of adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) and to evaluate the effects of iluzanebart on imaging and biomarkers of disease progression in subjects with ALSP. Participants will receive infusions of iluzanebart approximately every 4 weeks for 1 year. The study includes a 52-week, open-label Core Study, followed by a Long-Term Extension (LTE), which provides subjects who complete the original 52-week study (Core Study) with the option to continue treatment for up to an additional 2 years.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants who have documentation of a gene mutation in the CSF1R gene
* Participants fulfill both (Parts A and B) of the following criteria:

  1. The participant has more than 2 findings of clinical signs or symptoms in the following categories:

     1. Cognitive impairment or psychiatric problem
     2. Pyramidal signs on neurological examination
     3. Extrapyramidal signs, such as rigidity.
     4. Epilepsy
  2. MRI findings consistent with ALSP, specifically, bilateral cerebral white matter lesions with or without thinning of the corpus callosum, on the Screening MRI.
* The participant must have a study partner (i.e., caregiver, family member, friend, etc.) who, in the investigator's judgment, has frequent and sufficient contact with the subject so as to be able to provide accurate information about the participant's health and cognitive and functional abilities. The study partner must be willing to sign a study partner ICF.

Key Exclusion Criteria:

* The participant has any neurological disease that poses a risk to the participant or can produce cognitive, motor, or behavioral impairment similar to ALSP, including, but not limited to, brain tumor, hydrocephalus, Alzheimer's disease, frontotemporal dementia (FTD), ALS, stroke, Huntington disease, multiple sclerosis, Parkinson's disease, and Down syndrome.
* Participant with any condition or situation that, in the opinion of the investigator or sponsor medical personnel, may place the subject at significant risk, confound the study results, or interfere significantly with the participant's participation in the study.
Azacitidine in Treating Patients With Myelofibrosis

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis.

OBJECTIVES:

Primary

* Determine the efficacy of azacitidine in patients with myelofibrosis (MF) with myeloid metaplasia.
* Evaluate the safety of azacitidine in these patients. Secondary
* Evaluate pertinent biologic characteristics of MF before and during therapy with azacitidine.
* Assess the effects of study treatment on constitutional symptoms in these patients.
* Estimate time to event distributions for overall survival and progression. OUTLINE: Patients receive azacitidine subcutaneously once daily on days 1-5. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed myelofibrosis with myeloid metaplasia (MMM), including any of the following subtypes:

  * Agnogenic myeloid metaplasia
  * Post-polycythemic myeloid metaplasia
  * Post-thrombocythemic myeloid metaplasia
* Evaluable and symptomatic disease, defined as 1 of the following:

  * Anemia (hemoglobin \< 10 g/dL or erythrocyte transfusion-dependent, requiring 1 transfusion ≤ 8 weeks)
  * Treatment required\* for symptomatic palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) NOTE: \*Subjective but painful enough to mandate intervention
* Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics (by peripheral blood or marrow)

  - Previous demonstration of a lack of this translocation (at any point) is sufficient
* No advanced malignant hepatic tumors

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 50,000/mm³
* Creatinine ≤ 2.0 mg/dL
* Total bilirubin ≤ 2.0 mg/dL OR direct bilirubin ≤ 2.0 mg/dL if total bilirubin elevated (unless attributed to underlying disease)
* AST and ALT ≤ 2 times upper limit of normal (unless clinically attributed to hepatic extramedullary hematopoiesis)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No baseline peripheral or autonomic neuropathy ≥ grade 2
* No condition, including the presence of laboratory abnormalities, that would preclude study compliance
* No hypersensitivity to mannitol or azacitidine
* Not incarcerated in a municipality (i.e., county, state, or federal prison)

PRIOR CONCURRENT THERAPY:

* At least 14 days since prior chemotherapy, including interferon alfa, anagrelide, or other myelosuppressive agents
* At least 14 days since prior systemic corticosteroids
* At least 14 days since prior investigational agents
Ultrasound Guided Supraclavicular Brachial Plexus Block, Volume Comparison of Local Anaesthetics and Diaphragmatic Motility.

Brachial plexus block as done by landmark technique use large volume of local anaesthetics (at least 30-40 ml), leading to higher incidence of phrenic nerve involvement and diaphragmatic dysfunction. With use of ultrasound dose of local anaesthetic can be reduced. Volume as low as 20 ml when use by ultrasound guidance has shown to provide successful block with no hemidiaphragmatic palsy when compared with nerve stimulation technique. But no study has compared the different volumes of drug on success rate and diaphragmatic motility.So in this study , the investigators want to compare the incidence of hemidiaphragm paralysis and success of block with different volumes of local anaesthetic , so that the lowest effective dose with higher safety profile can be determined.


Eligibility Criteria:
Inclusion

* Age between 18 and 60 years undergoing distal arm surgery
* American Society of Anesthesiologists physical status 1 to 3
* Able to give informed consent
* Body weight greater than 50 kg

Exclusion

* Patient refusal for supraclavicular block.
* Inability to obtain informed consent.
* Contraindication to Brachial plexus block
* Pulmonary and cardiac disorders
* Pregnancy
* Allergy to local anesthetic
* Chest or shoulder deformities