cyrilzakka/clinical-trials huggingface dataset:
Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants

The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children using a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers.

The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children through a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers. The knowledge generated from this study will enable the Zambia Ministry of Health (MOH) to make informed policy decisions about the implementation and scale up of point of care (POC) diagnostic tools for early infant diagnosis and pediatric HIV treatment programs in Zambia and the region.

Eligibility Criteria:
Inclusion criteria include IYCs:

1. 0 days (at birth) - 17 months of age;
2. Probable or known HIV exposure documented through maternal sero-positivity or reactive infant HIV antibody test;
3. The IYC must be born to mothers who:

   1. attended ≥1 ANC visits without HIV testing; or
   2. delivered at home and did not return for post-natal care at a health facility, and thus the mother or their child were not tested for HIV; or
   3. were documented as HIV-infected but never initiated ART; or
   4. disengaged from HIV care after ART initiation/have not returned for ARV refills; or
   5. have not returned to the facility with their infant for initial EID testing or follow-up EID testing (after a negative test at birth or 6 weeks); or
   6. IYC not tested 6 weeks after cessation of breastfeeding.
4. With a parent/guardian ≥18 years of age, and willing and able to provide written informed consent in a study language (English, Nyanja, or Bemba).

Exclusion criteria include IYCs:

1. With documented age-appropriate, guideline-adherent receipt of DBS-based EID HIV PCR testing;
2. Already known to be HIV-infected / receiving ART.
The Effect of Environmental Factors on Colorectal Cancer Based on Macrogenomes

The aim of this study is to investigate the effects of environmental factors, such as air pollution, on the occurrence, development and prognosis of colorectal cancer; to identify metabolic markers specific to colorectal cancer patients, which will provide a basis for early diagnosis, early intervention and individualized treatment; and to comprehensively understand the mechanism of the occurrence and development of colorectal cancer by integrating the data of environmental factors and the macro-genome, and to develop new predictive and therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Patients diagnosed with colorectal cancer by pathologic biopsy before surgery;
* Patients did not undergo chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;
* Willing to participate in the study and sign an informed consent form. Complete clinical data.

Exclusion Criteria:

* Concurrent primary malignant tumor other than colorectal cancer;
* Patients with severe cardiopulmonary insufficiency or other systemic diseases that affect the choice of treatment plan;
* Inappropriate for enrollment as assessed by the investigator;
* Incomplete clinical data.
DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia

This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.

Background. The number of persons living with dementia is increasing in Denmark and worldwide because the population is generally growing older. Dementia with Lewy bodies (DLB) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia.

DLB is characterized by many prodromal symptoms years before dementia is evident. Currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of DLB can be clinically challenging, especially in the early stages. A novel technique for the measurement of misfolded alpha-synuclein (aSyn) is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process.

Objective: Determining which biospecimen alone or in conjunction with other biospecimens can most accurately discriminate patients with DLB from Alzheimer's disease (AD) assessed by RT-QuIC for aSyn.

Design: Cross-sectional case-control study of the diagnostic accuracy of pathological alpha-synuclein assessed by RT-QuIC in different biospecimens (CSF, skin, olfactory mucosa, saliva, feces, and urine) from patients with DLB versus AD.

Patients will also be scored with tests for cognitive function, dysautonomia, and movement disorders.

Eligibility Criteria:
Inclusion criteria for healthy controls (HC):

* Age 18 - 40 years of age
* Able to cooperate as evaluated by the primary investigator (PI)
* Able to give informed consent

Exclusion criteria

* Signs of neurological/psychiatric conditions
* Known genetic neurodegenerative disease in close family

Inclusion criteria for patients with Dementia with Lewy Bodies (DLB):

* Probable DLB (McKeith et al., 2017) or MCI-LB (McKeith et al., 2020)
* Age \> 50 years of age
* Able to give informed consent
* Able to cooperate as evaluated by the PI
* MCI, mild or moderate dementia, and MMSE \> 18

Exclusion criteria for patients with DLB:

* Patients not able to give informed consent.
* Current alcohol or drug abuse
* Terminal illness
* Diagnosed with major neurological/psychiatric conditions other than DLB.

Inclusion criteria for controls (patients with Alzheimer's disease (AD)):

* Probable AD (McKhann et al., 2011) or MCI-AD (Albert et al., 2011)
* Age \> 50 years of age
* Able to give informed consent
* Able to cooperate as evaluated by the PI
* MCI, mild or moderate dementia, and MMSE \> 18

Exclusion criteria for controls (patients with AD):

* Patients not able to give consent.
* Current alcohol or drug abuse
* Terminal illness
* Diagnosed with major neurological/psychiatric conditions other than AD.
Gustave Roussy Cancer Profiling

The objective of STING study is to perform high throughput molecular analysis (next generation sequencing +/- immunological profiling) to estimate the proportion of patients with cancer presenting at least one targetable genomic alteration.

STING is a biology driven, multicenter study designed to identify actionable molecular alterations in cancer patients and to explore mechanisms of sensitivity and resistance to anti-cancer treatment

* In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling
* Patients included in the STING study and for whom a targetable genomic alteration had been identified might be subsequently included in a clinical trial running at Gustave Roussy or another participating center.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Histology: solid malignant tumor or hematological malignancy.
3. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
4. Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

1. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol
2. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
3. Pregnant or breast-feeding women
4. Minors (Age \< 18 years)
A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis

The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR) tablets administered orally, twice daily are effective and safe in the treatment of patients with osteoarthritis of the knee or hip.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants between 40 and 80 years of age
* Diagnosis of moderate to moderately-severe osteoarthritis (OA) of either the knee or hip with respect to the following:

  * Pain in one knee/hip over 3 months immediately before screening visit
  * Use of non steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (paracetamol) or any other analgesic for 3 or more days per week for at least 3 months prior to screening visit
  * Clinical diagnosis of osteoarthritis of knee/hip for minimum 6 month duration prior to screening visit
  * Therapeutic benefit with acetaminophen use with a score of ≥ 1 on 5-point categorical scale
  * Radiological evidence of ≥ Grade 2 osteoarthritis according to Kellgren-Lawrence radiographic criteria
* Increased WOMAC Pain Subscale score of at least 20 % following untreated run-in period
* Moderate to moderately-severe self-reported pain on a 5-point categorical scale following untreated run-in period
* Historical self-reported positive therapeutic benefit with paracetamol use for osteoarthritis pain relief

Exclusion Criteria:

* History of surgery or major trauma to the study joint
* Clinically significant signs or symptoms of inflammation upon completion of run-in period
* Required ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments know to interfere with pain perception
* History of hepatic or renal or liver or biliary disease or gastrointestinal surgery
* Participants with alanine aminotransferase (ALT) \>2 times Upper Limit Normal (2xULN) and bilirubin \> 1.5 times Upper Limit Normal (1.5xULN) (However, if direct bilirubin is \<35% and fractioned, isolated bilirubin \>1.5xULN is acceptable)
* Other arthritis type, fibromyalgia or collagen vascular disease or secondary OA of study joint or chronic pain condition
Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors

The purpose of this study is to determine the maximum tolerated dose and recommended phase 2 dose of PF-03814735 administered orally as single agent in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic solid tumor resistant to standard therapy or for which no standard therapy is available
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Brain metastases that are symptomatic and/or require treatment with steroids and/or anticonvulsants, or brain metastases that have been treated within 3 months prior to study start
* Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months
Evaluation of Tadalafil Combined with LIPUS for Treating Erectile Dysfunction

This study aims to evaluate the clinical efficacy and histological changes of tadalafil combined with low-intensity pulsed ultrasound (LIPUS) in patients with erectile dysfunction (ED) through a randomized controlled trial.

Erectile dysfunction (ED) is defined as the persistent inability to achieve and maintain a sufficient erection for satisfactory sexual performance for more than six months. Low-intensity pulsed ultrasound (LIPUS), a non-invasive therapy, improves the pathological changes in the corpora cavernosa and penile hemodynamics by promoting the regeneration of connective tissue, blood vessels, and cavernous nerves, as well as reducing inflammation.

This study will recruit 114 patients diagnosed with ED and use simple random sampling to allocate them into a treatment group and a control group in a 1:1 ratio. The treatment group will receive daily 5mg tadalafil combined with LIPUS therapy twice a week for 4 weeks, followed by a 4-week interval without LIPUS treatment, and then repeat the treatment. The control group will receive only daily 5mg tadalafil.

Efficacy will be evaluated primarily through the minimal clinically important difference (MCID) of the International Index of Erectile Function-5 (IIEF-5) at each follow-up point, combined with Erectile Hardness Score (EHS), penile blood flow parameters, and elasticity values for comprehensive assessment.

This trial may provide additional clinical evidence for the efficacy, safety, and cost-effectiveness of tadalafil combined with LIPUS in treating ED patients. The inclusion of penile blood flow parameters and two-dimensional shear wave elastography will help establish a comprehensive evaluation system combining ED symptoms with histological assessment, providing new methods for efficacy evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Age between 21 and 65 years old.
* An International Index of Erectile Function-5 (IIEF-5) score of 21 or less.
* First-time diagnosis of erectile dysfunction (ED) without prior treatment from traditional Chinese or Western medicine.
* A stable heterosexual relationship for at least 3 months.
* Agreement to attempt sexual intercourse at least four times every four weeks during the study period.
* Signing of an informed consent form.

Exclusion Criteria:

* Erectile dysfunction caused by spinal/neural injury or radical prostatectomy.
* History of priapism or penile anatomical abnormalities.
* Use of a penile prosthesis.
* Severe and poorly controlled psychological disorders.
* Untreated endocrine disorders, such as hypogonadism, hypothyroidism, or pituitary dysfunction.
* History of myocardial infarction, stroke, life-threatening arrhythmias, or potential cardiovascular risks during sexual activity within the six months prior to enrollment.
* Inability to complete the participant records required for the trial.
* Allergic constitution and multiple drug allergies.
Efficacy/Safety of Cilnidipine Plus Valsartan Versus Valsartan in Patients With Hypertension

The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy


Eligibility Criteria:
Inclusion Criteria:

* essential hypertension patients whose blood pressure is not controlled before the study (sDBP≥90mmHg for drug-treated patients, sDBP≥95mmHg for drug-naive patients)

Exclusion Criteria:

* sSBP≥80mmHg after 4weeks of valsartan 160mg treatment
* has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
High Dose CVVHDF Compared to Standard Dose CVVHDF

In the last three decades, the mortality associated with acute renal failure (ARF) in the ICU has remained unchanged at greater than 50%, despite improvements in dialysis technology.

The primary objective is to determine whether Continuous Veno-Venous Hemodiafiltration (CVVHDF) using an ultrafiltration rate of 35 ml/hr/kg (high dose) leads to a greater reduction in all-cause ICU mortality compared to standard CVVHDF using an ultrafiltration rate of 20 ml/hr/kg.

Although the worldwide standard for renal replacement therapy is intermittent hemodialysis(IHD), continuous renal replacement therapy (CRRT) has emerged as an alternative form of renal replacement therapy in the critical care setting due to its advantages of slow continuous fluid removal, steady acid-base correction, and hemodynamic stability.

There are no standard protocols for initiating or administering CRRT, and practice patterns vary widely among institutions, with less than 25% of patients with ARF in the ICU receiving this therapy in the United States.

Various CRRT modalities are available that use diffusion, convection, or a combination of both to obtain adequate solute clearance. However, there is no consensus as to the optimal dialysis modality, adequate dialysis dose, or optimal clearance modality (convection vs. diffusion). Clinical trials are needed to determine the optimal method of administering CRRT, with respect to modality, dose of dialysis, and time of initiation of therapy.

Although some studies suggest that a higher dose of dialysis improves survival, there have been no prospective randomized studies comparing the effectiveness of diffusion and convection, combined together, for solute clearance.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \> or equal to 19 yrs of age
* ARF defined by at least one of the following:

  * Volume overload from inadequate urine output despite diuretic agents.
  * Oliguria (urine output \< 200 ml/12hrs) despite fluid resuscitation and diuretic administration.
  * Anuria (urine output \< 50 ml/12 hrs).
  * Acute azotemia (BUN \> or equal to 80 mg/dl).
  * Acute hyperkalemia not responsive to medication (K+ \> or equal to 6.5mmol/L)
  * An increase in serum creatinine of \> 2.5 mg/dl from normal values or a sustained rise in serum creatinine of \> or equal to 1 mg/dl over baseline.

Exclusion Criteria

* Patients with end stage renal disease
* Patients who have had more than one previous dialysis session for acute or chronic renal failure during the current hospitalization
* Patient weight greater than 125 kg
* Patient weight less than 50 kg
* Pregnancy
* Prisoner
* Non-candidacy for continuous renal replacement therapy (CRRT)
* Patient/surrogate refusal
DX-8951f in Treating Patients With Liver Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have liver cancer.

OBJECTIVES: I. Evaluate the antitumor activity of DX-8951f in terms of antitumor response, response duration, and survival in patients with hepatocellular carcinoma. II. Assess the quantitative and qualitative toxicities of this treatment regimen in this patient population. III. Evaluate the pharmacokinetics of DX-8951 in plasma.

OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed hepatocellular carcinoma with or without evidence of unresectable extrahepatic metastasis Previously untreated disease OR Progressive disease after first line chemotherapy Bidimensionally measurable disease by CT scan, chest x-ray, or MRI of the abdomen No brain metastases

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 80,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL Albumin at least 2.8 g/dL SGOT/SGPT no greater than 5 times upper limit of normal (ULN) PT/INR no greater than 1.5 times ULN if not on coumadin therapy Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: No concurrent serious infection No other life threatening illness No overt psychosis or mental disability that would preclude informed consent No other malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 1 month prior to and during the study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No prior camptothecin analogues No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No other concurrent anticancer therapy At least 4 weeks since prior investigational drugs (including analgesics or antiemetics) No other investigational drugs during or within 28 days after final dose of study drug
Data on Oral Contraceptives Compliance in Non Stop Regimen

Adherence to the dosing scheme is the principal element of COC efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study is to evaluate in everyday practice the relation between dosage errors and indicated factors, potentially influencing the compliance with the dosing scheme.


Eligibility Criteria:
Inclusion Criteria:

* Patients at the age of 18-50 requiring contraception, treated with oral contraceptives designed for the scheme 28 pills for 28 days. The decisions would be made at the discretion of the attending physician.

Exclusion Criteria:

* Patients were not valid for analysis if the initial visit was before start of study in the country (retrospective documentation), or if they did not take oral contraceptives designed for the scheme 28 pills for 28 days.
Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting

The primary objective of this exploratory cohort study is to describe levels of platelet reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (CABG).

The recent emergence of platelet reactivity testing as a potential option for evaluating the degree of platelet inhibition promises to add another level of understanding to our concept of CABG-related bleeding. There is an emerging literature that links high levels of platelet reactivity with adverse clinical events, primarily in patients on clopidogrel.

For example, studies of the VerifyNow P2Y12 platelet function assay have shown that Platelet Reactivity Units (PRU) \> 235-240 in patients on clopidogrel therapy appears to predict cardiovascular events.15,16 There is a paucity of literature, however, on the use of platelet reactivity testing to predict bleeding events and complications. In other words, if excessively high levels of platelet reactivity predict ischemic events, do excessively low levels of platelet reactivity predict bleeding events? This is an especially relevant question, given the emergence of prasugrel as a therapeutic option.

The investigators therefore propose an exploratory cohort study of patients receiving a thienopyridine (clopidogrel or prasugrel) and undergoing CABG, in order to describe levels of platelet reactivity in such patients by using a variety of platelet function tests.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old from both genders.
2. Taking maintenance thienopyridine therapy within 5 days of surgery OR received a loading dose of thienopyridine therapy within 48 hours of surgery for CABG.
3. Referred for CABG (which is scheduled to be performed during the current admission).

Exclusion Criteria:

1. Known allergies to aspirin, clopidogrel, or prasugrel.
2. Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of initial platelet reactivity testing.
3. Patient known to be pregnant or lactating.
4. Patient with known history of bleeding diathesis or currently active bleeding.
5. Platelet count \<100,000/mm the day of initial blood draw.
6. Hematocrit \<25% the day of initial blood draw.
7. On warfarin therapy at the time of initial blood draw.
8. Known blood transfusion within the preceding 10 days of the blood draw.
9. Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
10. Plan for patient to be discharged before undergoing CABG.
11. Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.