cyrilzakka/clinical-trials huggingface dataset:
Integration of Hypertension Management Into HIV Care in Nigeria

This study evaluates a tailored-practice facilitation (PF) strategy for integrating a task strengthening strategy for hypertension control (TASSH) for the care of patients living with HIV (PWH) within primary health centers (PHCs) in Lagos, Nigeria.

Although access to antiretroviral therapy has led to increased survival among people living with HIV (PWH) in Africa, this population now has higher cardiovascular disease (CVD) - mortality than the general population largely due to an increased burden of hypertension. In Nigeria, the acute shortage of physicians limits the capacity to control hypertension among PWH at the primary care level where the majority receive treatment. This study proposes the use of practice facilitation (PF) - which will provide external expertise on practice redesign and a tailored approach to delivery of the evidence-based task strengthening strategy - to integrate hypertension into the HIV care model. Using a clinical-effectiveness implementation design, we will evaluate the effect of a PF strategy for integrating an evidence-based intervention for hypertension (HTN) control into HIV care among 960 patients with uncontrolled HTN in 30 primary health centers (PHCs) in Nigeria. Study is in 3 phases: 1) a pre-implementation phase that will develop a tailored PF intervention for integrating TASSH into HIV clinics; 2) an implementation phase that will compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and 3) a post- implementation phase to evaluate the effect of PF vs. self-directed condition on the adoption and sustainability of TASSH. The PF intervention comprises: (a) an advisory board to provide leadership support for implementing TASSH in HIV clinics; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses

Eligibility Criteria:
Inclusion Criteria:

* Be an adult aged 18 years and older.
* Attends one of the 30 HIV clinics.
* Have a diagnosis of HTN with uncontrolled blood pressure, i.e. BP is 140-179/90-100 mm Hg.
* Ability to provide consent.

Exclusion Criteria:

* BP\>180/110 mm Hg;
* history of chronic kidney disease, heart disease, diabetes or stroke, pregnancy
* Inability to provide informed consent.
* Refusal to participate in the study.
Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia

GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is poor. Quantification of postpartum insulin sensitivity and secretion in women at high risk for T2DM will inform strategies to improve diagnostic strategies. Continuous glucose monitoring (CGM) is a new technology that may be useful to identify women with persistent hyperglycemia. Understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. Completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt T2DM.


Eligibility Criteria:
Inclusion Criteria for early GDM women:

* Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
* Gestational diabetes mellitus identified at \< 20 weeks' gestation requiring pharmacologic treatment (class A2)

Exclusion Criteria for early GDM women:

* History of prediabetes or polycystic ovarian syndrome
* History of pregestational type 2 diabetes mellitus
* Skin conditions which prevent wearing a continuous glucose monitor

Inclusion Criteria for 3rd trimester GDM women:

* Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
* Gestational diabetes mellitus identified at \>= 24 weeks' gestation requiring pharmacologic treatment (class A2)

Exclusion Criteria for 3rd trimester GDM women:

* History of prediabetes or polycystic ovarian syndrome
* History of pregestational type 2 diabetes mellitus
* Skin conditions which prevent wearing a continuous glucose monitor
Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients (TAPAS)

In this prospective observational study, the investigators want to document pharmacokinetic/pharmacodynamic (PK/PD) target attainment of frequently used antimicrobials in an adult non critically ill surgery population (abdominal surgery, traumatology and septic orthopedic surgery). Furthermore, the investigators want to identify risk factors for not attaining predefined PK/PD targets.

The antibiotics of interest are amoxicillin(-clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem and clindamycin.

In this research proposal, the primary objective is to describe PK parameters (area under the curve (AUC), clearance (Cl), distribution volume (Vd) and half life (T1/2)) for the antibiotics of interest (amoxicillin(-(clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem and clindamycin) for this adult non critically ill surgery population.

Besides, the investigators want to document pharmacokinetic/pharmacodynamic (PK/PD) target attainment of frequently used ABs in this population and to identify risk factors, for example augmented renal clearance (ARC), for not attaining predefined PK/PD targets.

Eligibility Criteria:
Inclusion Criteria:

Every adult non-critically ill surgery patient admitted at the abdominal, trauma or septic orthopaedic surgery wards from the University Hospitals Leuven treated with multiple doses of one of the antimicrobials of interest (i.e. intravenous (IV) amoxicillin(-clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem, oral or IV clindamycin) is eligible for inclusion.

Exclusion Criteria:

* age ≤ 18 years
* treatment restrictions corresponding to a Do Not Reanimate code
* pregnancy
* lactation
* renal replacement therapy
* planned discharge or surgery in the coming antimicrobial dosing interval making sampling impossible
Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy

Bile duct injury following cholecystectomy is an iatrogenic catastrophe associated with significant peri operative morbidity and mortality(1, 2) reduced long term survival(3) and quality of life(4, 5) and high rates of subsequent litigation6. It should be regarded as preventable.

The advent of laparoscopic cholecystectomy has resulted in a resurgence of interest in bile duct injury and its subsequent management. Population based studies(6.7) suggest a significant increase in the incidence of injury (0•1 to 0•5 per cent) following the implementation of the laparoscopic approach(8) Bile duct injury should be regarded as preventable, but over 70 per cent of surgeons regard it as unavoidable(9). Although most injuries occur within the surgeon's first 100 laparoscopic cholecystectomies, one third happen after the surgeon has performed more than 200; it is more than inexperience that leads to bile duct injury(10). It has been suggested that the commonest cause of common bile duct injury is misidentification of biliary anatomy (70-80 per cent of injuries)(11,12),a reduction in risk if surgeons perform routine intraoperative cholangiography Recognition of bile duct injury at the time of cholecystectomy allows an opportunity for the hepatobiliary surgeon to assess its severity and the presence of any vascular injury

Bile duct injury following cholecystectomy is an iatrogenic catastrophe associated with significant peri operative morbidity and mortality(1, 2) reduced long term survival(3) and quality of life(4, 5) and high rates of subsequent litigation6. It should be regarded as preventable.

The advent of laparoscopic cholecystectomy has resulted in a resurgence of interest in bile duct injury and its subsequent management. Population based studies(6.7) suggest a significant increase in the incidence of injury (0•1 to 0•5 per cent) following the implementation of the laparoscopic approach(8) Bile duct injury should be regarded as preventable, but over 70 per cent of surgeons regard it as unavoidable(9). Although most injuries occur within the surgeon's first 100 laparoscopic cholecystectomies, one third happen after the surgeon has performed more than 200; it is more than inexperience that leads to bile duct injury(10). It has been suggested that the commonest cause of common bile duct injury is misidentification of biliary anatomy (70-80 per cent of injuries)(11,12),a reduction in risk if surgeons perform routine intraoperative cholangiography Recognition of bile duct injury at the time of cholecystectomy allows an opportunity for the hepatobiliary surgeon to assess its severity and the presence of any vascular injury

Eligibility Criteria:
Inclusion Criteria:

* All patients with post cholecystectomy biliary tract injury admitted at Assuit university hospital at the period of the study

Exclusion Criteria:

* Any case with biliary leakage not post cholecystectomy
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer

The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary advanced inoperable disease who were refractory to chemotherapy
* Patients with recurrent disease following post-operative adjuvant chemotherapy
* Patients who were not amenable to post-recurrence chemotherapy

Exclusion Criteria:

* Patients with serious, uncontrolled medical illness
* Patients with previous therapy with taxanes
A Component Analysis of Acceptance and Commitment Therapy

The purpose of this study is to determine whether a specific component of Acceptance and Commitment Therapy (ACT) called 'Self as Context' is an important and necessary part of this therapeutic approach.


Eligibility Criteria:
Inclusion Criteria:

* Adults of working age (18-65)
* Patients with a primary positive diagnosis of a long-term health condition (The most common conditions referred to the service are Diabetes, Chronic Obstructive Pulmonary Disease \[COPD\], Rheumatoid Arthritis and Epilepsy) where there is a verifiable medical diagnosis supported by the patients General Practitioner (GP) and/or secondary care physician
* Patients with concurrent mental health difficulties (defined as mild - moderate anxiety and/or depression, see table one).

Exclusion Criteria:

* Patients with a primary diagnosis of 'medically unexplained symptoms' (MUS) including somatoform disorders (e.g. pain disorder, conversion disorder, body dysmorphic disorder, hypochondriasis) and functional somatic syndromes (e.g. irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, non-cardiac chest pain, non-epileptic seizures)
* Mental health diagnoses in addition to mild - moderate anxiety / depression (e.g. personality disorder, bipolar disorder, psychosis etc.)
* Patients in receipt of secondary care mental health services
* Patients with severe and enduring mental health difficulties
* Significant risk issues, or current substance misuse
* Previous contact with mental health services (defined as two or more prior episodes of contact without significant change)
* Inpatient admission for mental health difficulties within the last five years
* History of overdoses or other self-injury
* Stated reluctance to engage in psychotherapy
Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Related Cirrhosis: A Prospective Clinical Trial

Minimal hepatic encephalopathy (MHE) is an important clinical variant of hepatic encephalopathy (HE), which occurs in up to 60-70% of patients with cirrhosis. The condition comprises a cognitive impairment, observed in patients with cirrhosis who have no clinical evidence of overt hepatic encephalopathy (OHE). It is associated with an increased incidence of road traffic accidents, reduced quality of life and it affects the ability to perform tasks of daily living. Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. In addition, studies have shown that viral eradication may improve cognition when given interferon based regimens for HCV. With the available of safe, efficacious, all oral regimens for HCV, we plan to prospectively analyse the change in mood, depression and cognitive function in response to DAA therapy, in relation to outcomes of treatment.

Investigations will be performed according to the Declaration of Helsinki and approval of the enrolment as well as the usage of patient blood samples for research purpose will be obtained from the institutional ethics committee, and written informed consent will be obtained from all patients.The primary analysis upon which the sample size consideration was based involved the comparison of the SVR subgroup and the subgroup of patients without SVR. For the sample size calculation, we a two-factorial design (time course × SVR) with the use of a two-way analysis of variance (ANOVA) analysis, a significance level of 5% and a statistical power of at least 80% to detect a medium effect size (d = 0.5) and thus to show a significant group difference. Based on this background, the optimal sample size is calculated to be a total of 102 subjects. To consider asymmetric subgroups and to allow for a moderate dropout rate and additional calculations (secondary study objectives), we aim to include a total of at least 150 study participants in each group with 25 healthy volunteers as controls.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years and chronic HCV infection.
* Group A: Patients with hepatitis C (Non-cirrhotic) \[n= 150\]
* Group B: Patients with hepatitis C related compensated-cirrhosis \[n= 150\]
* Group C: Healthy volunteers \[n= 25\]

Exclusion Criteria:

* Current overt hepatic encephalopathy or during the last 1 month
* TIPS (transjugular intra- hepatic porto-systemic shunt)
* elective surgery planned within the next 8 weeks
* unable to give informed consent
* HIV infection
* chronic respiratory insufficiency
* current infection and receiving antibiotics
* renal failure (serum creatinine ≥ 1.5 mg/l)
* hepatocellular carcinoma,
* patient with other neurological disease
* intake of sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil, neuromuscular blocking agents)
Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer

The current hypothesis is that robotic-assisted surgery results in a reduced systemic and peritoneal inflammatory response (SIRS) compared to laparoscopic surgery in the treatment of colon cancer. The purpose is to evaluate differences in the peritoneal and systemic inflammatory response in robot-assisted and laparoscopic surgery of patients undergoing resection for colon cancer in a randomized, blinded controlled trial.


Eligibility Criteria:
Inclusion criteria

* Elective robotic-assisted or laparoscopic surgery for right-sided, left-sided and sigmoid colon cancer
* Aged ≥ 18
* ASA-score ≤ 3
* Tumor-stage (Tx-T4a)
* Endoscopic suspected colon cancer
* Histological verified adenocarcinoma, signet ring cell carcinoma, undifferentiated cancer, medullary carcinoma, or another malignant tumor type originating from colon
* Patients must give informed written consent
* Patients must be able to understand Danish language

Exclusion criteria

* Carcinoma of the transverse colon or synchronous colorectal cancer
* Previous history of colon cancer
* Previous open major abdominal surgery with exception of open appendectomy and cholecystectomy.
* Metastatic disease
* Pregnancy
* History of psychiatric or addictive disorder that would prevent the patient from participating in the trial
* Emergency colon surgery
* Co-existing inflammatory bowel disease
* Co-existing immunological disease that requiring ingestion of systemic immunomodulatory drugs (DMARD - disease modifying anti-rheumatic drugs), corticosteroids and biologic disease-modifying anti-rheumatic drugs.
* Daily consumption of NSAID drugs
HIFU in Patients With Non-malignant Thyroid Nodules

Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient 18 years or older.
* Patient presenting with at least one thyroid nodule with no signs of malignancy:

  1. Non suspect clinically and at ultrasonography imaging
  2. Benign cytological diagnosis at fine-needle aspiration biopsy (FNAB) from the last 6 months
  3. Normal serum calcitonin
  4. No history of neck irradiation
* Normal thyroid-stimulating hormone (TSH).
* Targeted nodule accessible and eligible to HIFU
* Absence of abnormal vocal cord mobility at laryngoscopy.
* Nodule diameter ≥ 10mm measured by ultrasound.
* Nodule volume inferior to 10 cc
* Composition of the targeted nodule(s) : no more than 30% cystic

Exclusion Criteria:

* Head and/or neck disease that prevents hyperextension of neck.
* Known history of thyroid cancer or other neoplasias in the neck region.
* History of neck irradiation.
* Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
* Posterior position of the nodule if the thickness of the nodule is \<15mm
* Pregnant or lactating woman
* Any contraindication to the assigned analgesia/anaesthesia.
EFFECTS OF TRANEXAMIC ACID IN TUMESCENT SOLUTION FOR LIPOSUCTION PROCEDURES

The goal of this trial is to evaluate the effect of adding Tranexamic Acid (TXA) to the tumescent solution used in arm liposuction on postoperative outcomes. Study population includes healthy volunteer adults undergoing Liposculpture procedures. The main question it aims to answer is:

1. Does Tranexamic acid exert benefit on postoperative outcomes after liposuction? Researchers will compare TXA versus traditional tumescent solution to see if there are benefits on adding it to the tumescent solution.

Participants will undergo High Definition Liposculpture involving arms, legs and their torso. One arm will be infiltrated with traditional Klein's tumescent solution and the other one with the same one but adding Tranexamic Acid.

Study Design:

Allocation: Randomized (one arm with TXA, one without) Intervention Model: Crossover assignment (each subject serves as their own control with one arm receiving TXA and the other not) Masking: Double-blind (Participant and Outcomes Assessor)

Interventions:

Experimental Arm (TXA): Infiltration with Klein's tumescent solution (1000 ml of Ringer's Lactate + Epinephrine 1 mg + Lidocaine 1 mg) plus 250 mg of tranexamic acid.

Control Arm: Infiltration with Klein's tumescent solution (1000 ml of Ringer's Lactate + Epinephrine 1 mg + Lidocaine 1 mg) without tranexamic acid.

Recruitment Information:

Adults aged 18-60 undergoing elective High Definition liposuction. No known allergies to TXA or lidocaine. BMI of 30 kg/m\^2.

Study Start Date: January 2022. Primary Completion Date: January 2024. Study Completion Date: June 2024. Study Locations: Clinica Dhara, Bogota DC, Colombia.

Data Collection: Photomicrographic analysis with ImageJ (Fiji): Photos taken on days 1, 3, and 7 will be processed to calculate the surface area of ecchymosis.

Manual arm circumference measurements: Measurements will be taken with a tape measure to monitor local swelling/inflammation.

Ethical Considerations:

Informed Consent: Participants will be provided with detailed information about the study and will be required to provide informed consent prior to participation.

IRB Approval: The trial will be conducted in compliance with ethical standards and will be reviewed and approved by an Institutional Review Board (IRB).

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-60 undergoing elective arm liposuction.
* No known allergies to TXA or lidocaine.
* BMI \&lt; 30.

Exclusion Criteria:

* Previous surgery or trauma to the arms.
* Known coagulation disorders.
* History of thromboembolic events.
* ASA \&gt; II.
Bevacizumab Plus MFOLFOXIRI As First-line Treatment for Patients with Unresectable Metastatic Colorectal Cancer

The current clinical trials and data on the triplet regimen combined with bevacizumab for first-line treatment of metastatic colorectal cancer were from European and American populations. The triplet regimens recommended by the NCCN and ESMO guidelines using irinotecan and 5-FU at a higher dose intensity cause a high incidence of adverse events in Asian population, and there was no high-quality data on efficacy in Chinese population, both of which have limited the clinical applications of the regimens in China. This study intends to conduct an improved triplet regimen (mFOLFOXIRI) combined with bevacizumab versus mFOLFOX6 combined with bevacizumab as a first-line multicenter, randomized, controlled phase III clinical trial in patients with advanced colorectal cancer. Progression-free survival (PFS), observable response rate (ORR), overall survival (OS), disease control rate (DCR), surgical resection rate, and safety and health-related quality of life (HRQoL) were assessed in the two groups of subjects.


Eligibility Criteria:
Inclusion Criteria:

- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.

Subjects with metastatic colorectal cancer(CRC) (Stage IV). Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 12 months of completion of adjuvant therapy.

Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study.

Metastatic CRC subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.

Exclusion Criteria:

- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.

Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.

Heart failure grade III/IV (NYHA-classification). Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.

Subjects with known allergy to the study drugs or to any of its excipients. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.

Breast- feeding or pregnant women Lack of effective contraception.