cyrilzakka/clinical-trials huggingface dataset:
Impact Evaluation of the Nigeria Result-Based Financing Project

The World Bank and the government of Nigeria are implementing a results-based financing (RBF) project for the states of Nasarawa, Adamawa, and Ondo. This project provides incentives for improving performance at critical levels within the Nigerian health system and aims to address some of these challenges. The primary goal of the impact evaluation of this project is to determine if providing financial incentives linked directly to performance increases the quantity and quality of maternal and child health (MCH) services.

In each of the three selected States,the project finances the following interventions:

1. Performance incentives to State Government and Local Government (LGA) agencies that are triggered by Disbursement Linked Indicators (DLIs) that reflect strengthened supervision and enhanced operational support for improving health systems performance. These performance incentives would be paid out on an annual basis.
2. In half of the LGAs in each state, one facility per ward will receive Performance-Based Financing (PBF) wherein payments are made directly to individual health facilities based on the quantity and quality of a set of pre-defined services provided by each facility. These performance incentives would be paid out on a quarterly basis.
3. In the other half of the LGAs in each state one facility per ward will receive Decentralized Facility Financing (DFF) or equivalent financing that is not be linked to any service delivery targets. These payments would be made on a quarterly basis.

The evaluation of the PBF arm, which consists of making payments to health facilities conditional on performance, but within an environment of comparable levels of overall financing, will rely on experimental assignment. The effect of the PBF intervention will be identified by comparing outcomes in the LGAs receiving PBF versus those receiving DFF in the three project states. In each of these three States, the LGAs will be randomly assigned to either the PBF package or to the DFF package.

A detailed description can be found in the attached project concept note.

Eligibility Criteria:
Inclusion Criteria:

1. All health facility staff in the states of Nasarawa, Adamawa and Ondo attending to maternity patients in the study period.
2. Selected mothers recently utilizing the same facilities if consent is provided.

Exclusion Criteria:

1. None.
Influence of Tobacco Use on Cannabis Use

Cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis relapse relative to those who do not use tobacco. There is a clear need to develop and evaluate interventions for dual tobacco and cannabis users. The investigators of this study have previously shown that the co-use of tobacco cigarettes contributes to the maintenance of daily cannabis use, and that age of cigarette onset is a critical predictor of treatment outcome. Short-term tobacco cessation may suffice in altering cannabis relapse rates in later-onset cigarette smokers, while a longer period of tobacco cessation may be needed for earlier-onset smokers. In the current study, a human laboratory model will be utilized to determine whether cannabis relapse varies as a function of tobacco cessation duration and age of tobacco use onset.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant females aged 18-60 years old
* Use cannabis
* Smoke tobacco cigarettes
* Medically and psychologically healthy

Exclusion Criteria:

* Regular drug use other than cannabis
* Current pregnancy/lactation
Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer

The purpose of this study is to find out whether people who have had thyroid cancer develop resistance to treatment with thyroid hormones after having received high doses of thyroid drugs for many years.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Due to a diagnosis of thyroid cancer, patient underwent a total thyroidectomy based on pathology.
* No evidence of active disease based on routine surveillance testing showing no suspicious findings on neck ultrasound and low thyroglobulin levels (≤1.0 ng/ml) with negative thyroglobulin antibodies within one year of study enrollment. For the study patients, this response can be evaluated after five years of TSH suppression. For control subjects, this response can be evaluated after two years of surveillance.
* Two groups:

  * 8 patients with a history of thyroid hormone suppression (TSH\<0.5 mU/L) for at least 5 years
  * 8 patients with no history of TSH suppression
* Normal TSH level based on the laboratory reference range for at least 6 months at the time of study enrollment.
* Blood pressure range of \>90/60 and \<180/100. Patients may be included in the study if blood pressure has been treated with medication and normalized.

Exclusion Criteria:

* Patient reported history of symptomatic heart disease including unstable angina or NYHA stage III or IV heart failure.
* Patient reported history of one of the following cardiac arrhythmias: atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, ventricular fibrillation, or ventricular tachycardia.
* Patient reported history of uncontrolled hypotension (\<90/60) or hypertension (\>180/100).
* History of renal dysfunction with creatinine more than 1.5 times the upper limit of normal based on recent laboratory testing
* Known hypersensitivity to the drug
* Pregnant or breast feeding
* Prior history of seizures or brain damage
* Patients on chronic therapy with levodopa
* Patients on therapeutic doses of acetylsalicylic acid (2 - 3.6 gm/day)
* Patients with conditions that result in disruption of the hypothalamic-pituitary axis (i.e. hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma).
Ultrasound-guided Genicular Nerves Block

Most of arthroscopic ACL repairs are day case surgeries associated with moderate postoperative pain and discomfort. So , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay.

in this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.

In this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.

Eligibility Criteria:
Inclusion Criteria:

* both genders
* age 18 - 65
* ASA i, ii, iii

Exclusion Criteria:

* ROM less than 90
* advanced renal or liver diseases
* patient refusal
* substance abuse
* site infection
* known sensitivity to any of study drugs
ClearPath DS-120 Clinical Study Protocol

The goal of this study is to measure lens fluorescence in normal subjects at various chronological ages that could serves as a guide to clinicians in determining changes in eye health. A measure of lens fluorescence can be used by clinicians as an indication of degenerative changes occurring in the lens of the eye.


Eligibility Criteria:
Inclusion Criteria:

* Persons between the ages of twenty-one (21) and seventy (70). Best efforts shall be made to include as many patients as possible between the ages of thirty-five (35) and sixty (60).
* Subject must be able to read or understand and give informed consent.
* Pass the medical health history and comprehensive ophthalmic examination (which is determined by the investigator if the test subject has a normal ophthalmic examination and is in overall good health). Ophthalmic examination includes a clinical evaluation of the subject's eyes and a complete manifest refraction producing a best aided visual acuity of \<20/40.

Exclusion Criteria:

* Subject has had the crystalline lens removed from the study eye or has had the crystalline lens removed and replaced with an intraocular lens (IOL) implant in the left eye.
* Subject has been clinically diagnosed with cataracts in the study eye.
* Subject has had a fluorescence angiogram within the last six months.
* Subject has undergone a treatment using photodynamic drugs within the last year.
* Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam.
* Subject was fit with contact lens within the last 30 days.
* Subject has ocular surface (dry eye) disease.
* Subject is unable to cooperate with or understand clinical instructions.
* Subject is unable to complete test sequence
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis

PandrTB is a study of the pharmacokinetics(PK) and pharmacodynamics(PD) of bedaquiline, delamanid, clofazimine, linezolid, moxifloxacin, levofloxacin and pyrazinamide used in novel combinations to treat multidrug-resistant tuberculosis(MDR-TB).

PandrTB is an observational study nested in the endTB (a randomized study that will evaluate five 9-month, injectable-sparing regimens) and endTB-Q (and RCT evaluating a 4 drug oral regimen given for 6 or 9 months) trials. These trials are providing evidence to support the transformation of MDR-TB treatment. As part of PandrTB: the plasma concentrations of the experimental arm drugs (the new and repurposed drugs bedaquiline, delamanid, clofazimine and linezolid, as well as levofloxacin, moxifloxacin and pyrazinamide) will be measured; MICs will be determined in baseline isolates; and MGIT cultures, additional to those in the endTB study, will be performed at weeks 6 and 10. Nonlinear mixed-effects models will describe the population PK of the drugs and a pharmacodynamic (PD) model of treatment response of Mycobacterium tuberculosis(Mtb) load over time. Recursive partitioning methods will evaluate baseline MICs and PK measures as drivers of treatment response (as described by the parameters of the PD model of initial treatment response of Mtb load over time, and the endTB trial endpoints: time to culture conversion, longer-term outcomes, and acquisition of phenotypic resistance). Thus the key drugs and plasma drug exposure thresholds for activity will be defined, and exposure-dependent synergy or antagonism identified. The risks of toxicities (as assessed in the endTB study) will be estimated, by plasma drug exposure and important comorbidity (including HIV infection). In this way, the PK-efficacy and PK-toxicity analyses will allow definition of target plasma drug exposures. Simulations will predict optimal doses. To advance the understanding of drug penetration, we will develop approaches to measure free drug plasma concentrations. Drug-drug interactions will be described. Thus PandrTB will inform how best to use these new and repurposed drugs in combination, to create the most effective and least toxic regimens while minimizing the development of further drug resistance.

Eligibility Criteria:
Inclusion Criteria:

All patients enrolled to the experimental arms of the endTB study and provide their written informed consent to participate in the PandrTB study.

Exclusion Criteria:

-
Impact of Twin Block and Motion Class II Appliances on Hyoid Bone Position - A Retrospective Clinical Study

Analyse the impact Twin block appliance and Motion on Hyoid Bone

Patients were selected, divided en two homogenous groups and underwent preoperative and postoperative lateral teleradiograph scans. The datasets were subsequently uploaded into a digital treatment planning software to record the position changes of the hyoid bone at horizontal, vertical, angular, and airway complex level; additionally, the effect of gender, age at onset, treatment time, biotype, and their interactions with the group, have been also statistically evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 10 and 16 years old, with sketelal class II, a ANB angle ≥4° according to the Steiner cephalometric analysis, with Twin block or Motion appliance

Exclusion Criteria:

* without previous orthodontic treatment, without systemic disesases and adenotonsillar hypertrophy.
Irofulven in Treating Patients With Metastatic Colorectal 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 irofulven in treating patients with metastatic colorectal cancer.

OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene (MGI-114) when given daily for 5 days every 28 days to patients with metastatic adenocarcinoma of the colon or rectum. II. Evaluate the qualitative and quantitative toxicities of MGI-114 given on this schedule in this patient population.

OUTLINE: Patients receive 6-hydroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 consecutive days. Courses are repeated every 28 days. The minimum treatment period is 2 courses. Treatment continues indefinitely in the absence of unacceptable toxic effects or disease progression. Patients are followed at the end of every other course while on the study, and then every 3 months thereafter until death.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 6-10 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the colon or rectum Bidimensionally measurable lesions Sentinel lesions outside the field of any prior radiation therapy No confirmed or suspected brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No active congestive heart failure No uncontrolled angina At least 6 months since prior myocardial infarction No uncontrolled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No overt psychosis or mental disability No life threatening illness (unrelated to tumor)

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiation therapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: At least 28 days since prior administration of any investigational drug No other concurrent anticancer therapy
SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease

This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.

In this study, we hypothesize that metabolomics changes that occur in patients with T2DM after initiating SGLT2i (sodium-glucose cotransporter 2 inhibitors) treatment may be responsible for the beneficial cardiovascular and kidney effects observed in clinical trials with SGLT2i. Also, we propose that the study of the specific metabolome associated with the treatment with SGLT2i could help identify the possible metabolites and molecules that reduce CVD (cardiovascular disease) and renal disease in patients with T2DM.

The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily of for 12 weeks. Besides, all participants will be advised to engage in 150 min or more of moderate-to vigorous intensity physical activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity and to engage in 2-3 sessions/week of resistance exercise on nonconsecutive days. Moreover, these patients will be advised to follow a lifestyle program that achieve a 500-750 kcal/day energy deficit or provide≈1,200-1,500 kcal/day for women and 1,500-1,800 kcal/day for men, adjusted for the individual's baseline body weight.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75.
* BMI 27-39.9 kg/m2.
* T2DM on treatment with metformin and inadequate metabolic control (defined as HbA1c≥6.5 -7%).

Exclusion Criteria:

* Pregnancy (all women of child-bearing age, unless on treatment with contraceptive methods, will undergo a pregnancy test)
* Breastfeeding
* Intolerance/allergy to dapagliflozin.
* Treatment with antidiabetic drug other than metformin.
* Impaired kidney function: Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 (calculated using the CKD-EPI formula).
* Patients with established cardiovascular disease.
* Previous or current history of cancer of any kind.
* Uncontrolled hypertension (systolic blood pressure≥160 mmHg or diastolic blood pressure≥110 mmHg, despite adequate antihypertensive treatment).
* History of liver tumour or acute or chronic liver disease with impaired liver function: total bilirubin levels\> 2.0 mg / dl or GOT/GPT levels three times higher than normal upper limit.
* Known HIV infection or active HBV or HCV infection.
* Other serious underlying diseases, which could affect the patient's ability to participate in the study.
* Reduced life expectancy (\<12 months) due to advanced or terminal concomitant diseases.

In addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice.
University of Virginia Natural History Study

Data and specimens will be collected longitudinally from patients seen in the UVA Interstitial Lung Disease (ILD) clinic in order to describe the phenotypic expression of various interstitial lung diseases. Samples will also be collected from a control group for comparison purposes.

All data will be entered into a repository for future research purposes or screening for new studies that become available. This data will help identify trends and hopefully lead to a better understanding of the disease progression, treatment options, and outcomes.

Following the clinical course of patients with ILD will allow description of the natural history of these diseases and prospective analysis of the following specific questions:

1. Can surrogate physiological markers of disease progression be used in place of mortality? Mortality of a defined cohort of patients will be developed. The surrogate markers include but are not limited to serial cardiopulmonary exercise testing, pulmonary function testing, 6-minute walk testing, HRCT scanning and echocardiography.
2. Do alternative assessments such as quality of life (QOL) questionnaires provide early prediction of physiological change as measured by the previously described parameters? Periodic QOL questionnaires are regularly conducted in clinic and will be followed
3. Does rate of deterioration as measured by these previously described parameters affect response to therapy? If we pre-identify rapid decliners from stable subjects, does this variable affect the response to whatever therapy is applied?
4. Can genetic analysis, genomics, proteomics, microbial and other biomarkers in the blood and cheeks provide insight into the polymorphisms and other elements related to the etiology and pathology of the lung damage?

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting to University of Virginia ILD or Pulmonary clinic
* Family members accompanying patients (as control subjects)

Exclusion Criteria:

* Control subjects cannot have ILD
Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service.

Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service.

Patients' clinical data (recruited from the outpatient clinics and wards of Hospital das Clínicas from the Faculty of Medicine of Botucatu) will be collected in a specific form, developed to this work, containing the following data: demographic characteristics (name, age, sex, race, profession, marital status, monthly income and education), main diagnosis and diseases associated, assessment of comorbidities using the Charlson Index, and Hospital Health Scale.

Anxiety and Depression (HAD Scale), use of maintenance medications, history of smoking (active or not, calculation of smoking load), body composition (mass index body- BMI calculation) and pulse oximetry measurement. All patients included will undergo low-dose radiation tomography and spirometry. All patients active smokers, who wish to stop smoking, will be referred to the outpatient clinic smoking cessation. Specific measurements will be applied if there is a diagnosis of COPD by spirometry (the BODE Index questionnaires, Dyspnea Index-Medical Modified Research Council, TC6) and patients will be referred to the outpatient clinic specific COPD for follow-up in the service. Subsequently, the anxiety and depression assessments. The tracking protocol will follow the recommendations of repeat the low-dose radiation chest tomography every year, if normal, until complete two years of follow-up. In this case, the patient will be discharged from the tracking. If the patient presents changes in the tomography, follow-up protocol according to the size of the lesions will be carried out. Morbidity and mortality assessment will be carried out in patients diagnosed with lung cancer.

Eligibility Criteria:
Inclusion Criteria:

Age between 45 and 74 years old; Smoker with a smoking history of at least 30 pack-years or former smoker who has quit smoking for less than 15 years; Never having participated in a lung cancer screening program; Signing of the free and informed consent form.

Exclusion Criteria:

Patients with chronic diseases (cardiovascular, pulmonary, hepatic, renal or metabolic) at an advanced stage that limit life expectancy or make it impossible to perform a curative surgical procedure; Patients being treated for tuberculosis or other granulomatous diseases; Patients diagnosed with previous neoplasm(s) that could develop lung metastases; Pregnant women; Patients who, for some reason, are unable to undergo low-dose chest computed tomography; Patients previously submitted to thoracic radiotherapy.
Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury

Preliminary evaluation of depth electrode recording and novel algorithms to determine Cortical Spreading Depolarization's (CSD) following traumatic brain injury (TBI) requiring neurosurgical intervention.

During the standard of care External Ventricular Drain (EVD) placement, a depth electrode with minimal modification to the standard surgical procedure will be placed. This will allow electrocorticogram (ECoG) recordings. An ECoG will be reviewed by a study Neurosurgeon to understand the association between cortical spreading depression and pathological findings on imaging. The recordings help create a novel algorithm in order to detect CSD's. This may ultimately provide significant benefit to society through the diagnosis and treatment of secondary injury associated with traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Patient recommended to undergo EVD placement for the monitoring and possible treatment of Intracranial pressure (ICP) after TBI

Exclusion Criteria:

* Contaminated scalp lacerations
* Known systemic infection
* Non-English speaking
* Fixed, uncorrectable coagulopathy