cyrilzakka/clinical-trials huggingface dataset:
The Cost-effectiveness of Screening for Diabetic Retinopathy in Hong Kong

Introduction: There is no debate that people with diabetes should be screened for the development of retinopathy which can threaten their sight. However, there is no routine screening for retinopathy in Hong Kong at present. Many overseas countries find that they miss a large proportion of their target population and, with reliance on co-payments for screening, as is the case with the limited opportunistic screening at present, the cost-effectiveness of any routine service in Hong Kong could be reduced as is predicted by Hart's inverse care law.

Aim: This study will determine the potential cost-effectiveness of screening for retinopathy in Hong Kong under a free system and one in which a co-payment is charged.

Methods: Primary care patients attending General Outpatient Clinics on Hong Kong Island for their routine diabetic care will randomly be offered screening either at no charge or with the normal co-payment of $65. Those who are willing and unwilling to be screened will be compared for their clinical, lifestyle and socioeconomic characteristics and those unwilling will be asked their reasons. The uptake of screening at no fee and with a payment will be compared as will the prevalence of retinopathy in the two fee groups. Subsequent screening at one year will be offered at the same fee and uptake again compared.

The principal analyses will (a) identify the characteristics of those willing to be screened and reasons for not being screened (b) the uptake of screening when a co-payment is charged compared to when it is free (c) whether there is a difference in the prevalence of retinopathy between the group willing to pay and those who accept free screening and (d) the uptake of re-screening in year 2.

The resulting cost-effectiveness model will use these data, the cost data collected during the study and overseas data on benefits of treatment to model the cost-effectiveness of screening for retinopathy in Hong Kong if it were to be offered free or with a co-payment. This information will be important to determine the most cost-effective means of implementing this preventative strategy to preserve sight and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* All diabetic patients who attend the clinic during the study period.

Exclusion Criteria:

* Only if not competent to give informed consent
Azithromycin Combination Therapy for the Treatment of Severe Malaria

A randomized controlled trial to assess the safety and efficacy of azithromycin combination therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated malaria patients in southeastern Bangladesh.


Eligibility Criteria:
Inclusion Criteria:

Male and female participants with a diagnosis of acute falciparum malaria meeting all criteria listed below may be included in the study:

1. Acute symptomatic falciparum malaria infection with a parasite density of 100 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5ºC), or reported history of fever within the last 48 hours.
2. Age: 8-65 years old
3. Males or females. All females over the age of 12 are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception, such as implant, injectable, oral contraceptive(s) with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study
4. Written informed consent obtained
5. Willing to stay under close medical supervision for the study duration
6. Otherwise healthy outpatients

Exclusion Criteria:

Participants presenting with any of the following will not be included in the study:

1. Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception (as described in Inclusion Criteria, #3)
2. Mixed malaria infection on admission by malaria smear
3. A previous history of intolerance or hypersensitivity to the study drugs artesunate, azithromycin or to drugs with similar chemical structures
4. Malaria drug therapy administered in the past 30 days by history
5. History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
6. Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
7. Signs or symptoms of severe malaria (as defined by WHO 2003)
8. Unable and/or unlikely to comprehend and/or follow the protocol
Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study was to compare the proportion of patients with a reduction of mean GH level to \<2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients could proceed into the study extension.

Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.


Eligibility Criteria:
Inclusion criteria:

* Patients with active acromegaly (based on elevated GH and IGF-1 levels)
* Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
* Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity

Exclusion criteria:

* Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization
* Patients with compression of the optic chiasm causing any visual field defect
* Patients who have received pituitary irradiation within the last ten years prior to visit 1
* Poorly controlled diabetic patients

Other protocol-defined inclusion/exclusion criteria may apply
Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions

The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions.

This study will be a Thailand, clinic-based, cross-sectional, questionnaire study. Approximately 151 female participants will be enrolled. Study staff will interview the subject to collect basis demographic data and self reported medical history. And the subjects will be given the questionnaire packet for self-administration. After subjects complete the packet, study staff will review the questionnaires for completeness prior to the study subject leaving the clinic.

Eligibility Criteria:
Inclusion Criteria:

* female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months.

Exclusion Criteria:

* has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
* has other concurrent/active STD's
* has a history of known prior vaccination with an HPV vaccine
* has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse.
The Trajectory of Physical Activity Following Pulmonary Rehabilitation

Pulmonary rehabilitation clearly increases exercise capacity, but its effect on physical activity in the home and community settings is less clear. It may take a longer time for this increase in physical activity to occur. It has been stated in an editorial that it takes 3 months to train the muscles but 6 months to train the brain. The Investigators will first evaluate the change in physical activity following pulmonary rehabilitation using state-of-the-science motion detectors, then Investigators will follow the trajectory of physical activity over the next several months.

This study will follow physical activity following pulmonary rehabilitation longitudinally over 48 weeks. Investigators will use a state-of-the-art accelerometer, to analyze minutes walking per day as the primary outcome, rather than vector magnitude units (VMU) or estimated steps per day. Investigators will explore potential factors influencing this important outcome, including baseline activity levels, demographic variables, changes in exercise capacity, psychological variables, and self-efficacy scores. Finally, Investigators will evaluate the rate of change (trajectory) in physical activity over approximately six months after pulmonary rehabilitation. There are limited data suggesting it takes time for the translation of increased exercise capacity into increased physical activity to occur.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (≥ 40 years) with a primary clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
2. A post-bronchodilator forced expiratory volume in one second(FEV1)/forced vital capacity (FVC) \< 0.70 from spirometry performed within the preceding 12 months (no specific FEV1 percent-predicted requirement, although we anticipate the FEV1 will average around 45% of predicted, based on previous studies of pulmonary rehabilitation)
3. The patient was referred to pulmonary rehabilitation
4. The patient is clinically-stable: no exacerbation in preceding 4 weeks
5. Modified Medical Research Council (mMRC) dyspnea rating of at least 2 out of 5.

Exclusion Criteria:

1. Disease severity or co-morbidity that would make the patient be at-risk for participation this study
2. A significant movement disorder, such as hemiplegia, etc.
3. Inability to read and comprehend the questionnaires, which will be in English
4. A history of poor wound healing or chronic skin conditions that might predispose to local problems from wearing the DynaPort. (The DynaPort can be worn outside a thin garment, such as a tee shirt, and is relatively thin, without protruding parts. However, since the device may be worn overnight, and there is a remote risk of pressure problems, this exclusion criterion was added).
HFSRT With Concurrent TMZ for Large BMs

A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

A previous single arm phase II trial and propensity- matched study of our institution have shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than HFSRT alone group. Thus, the investigator conducted this randomized phase III trial to broad the sample size and verify our previous results. To finish the study in time, the investigator designed a multi-center trial.

Eligibility Criteria:
Inclusion Criteria:

* histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;
* the number of BMs ≤ 3
* the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm;
* Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs;
* Age: 18-75 years old;
* Adequate function of major organs, and blood test reached the following level: WBC≥4.0x109/L, NEU≥1.5x109/L Hemoglobin≥110 g/L, Platelets≥100 x109/L; Liver function test results\<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range.

Exclusion Criteria:

* patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);
* unable or unwilling to comply with the study protocol;
* patient whose survival expectancy was less than 3 months;
* the large BM locates in brainstem;
* patient who anticipated in other clinical trials of brain metastases;
* the large lesions have been treated with SRT in other hospitals;
* pregnant patients or female patients whose HCG is positive.
Carnitine Levels and Carnitine Supplementation in Type I Diabetes

The purpose of this study is to determine whether type I diabetics with carnitine deficiency exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour glucose monitoring.

Hypoglycemia is a clinical marker of carnitine deficiency. Thus carnitine may compound the risk of hypoglycemia for children on insulin therapy. Currently, one of the limitations in the management of diabetes is hypoglycemia. The problem of hypoglycemia is of even greater significance in the pediatric population because children have smaller glycogen stores.

In this study, we will determine if there is a group of children with increased frequency of hypoglycemia and carnitine deficiency. If there is a correlation from the initial 200 children, we will compare two groups of type I diabetic children between the ages of 7 to 21 years. We will take 20 children with the highest carnitine levels (found in a previous study) and 20 children with the lowest carnitine levels and perform continuous glucose monitoring for a 72-hour period. Those who have at least one episode of hypoglycemia will be asked to undergo repeat testing, after a 2-week period of oral carnitine supplementation. Supplementation will start at 50 mg/kg body weight for the first week and then increase to 100 mg/kg body weight the second week. Laboratory studies obtained at baseline include Hemoglobin A1c, carnitine panel, and lipid panel. These will be repeated prior to the second continuous glucose monitoring. Insulin doses will not be changed between glucose monitoring sessions. A comparison will be made between individuals with hypoglycemia, to see if the number of hypoglycemic events has decreased.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus, Type I for greater than 2 years between the ages of 7 and 21
* currently on insulin replacement therapy

Exclusion Criteria:

* Patients with newly diagnosed Type I diabetes
* Patients already taking L-carnitine
* Patients who come to clinic without glucose monitors
* Patients with known seizure disorders not including hypoglycemic seizures
* Patients on metformin
* Patients with compromised renal function.
DAW1033D in Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of DAW1033D administered before sleep on OSA phenotype traits and OSA severity during sleep.


Eligibility Criteria:
Inclusion Criteria:

- AHI \> 15

Exclusion Criteria:

* Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia
* Any medication known to influence breathing, sleep/arousal or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to lidocaine, Oxymetazoline HCl, DAW1033D.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, or any of the studied medications for medical care.
* History of seizures
* For women: Pregnancy.
* History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism
A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer

The overarching long-term goal of the Integrative Medicine for Patient-reported Outcomes Values and Experience (IMPROVE) research program is to evaluate whether integrating a virtual mind-body programming, Integrative Medicine at Home (IM@Home), will improve patient perceived values, outcomes, and experiences as they undergo systemic cancer treatment such as chemotherapy, immunotherapy, radiotherapy, targeted agents, cytoreductive surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or older
* Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer
* Actively receiving systemic oncological treatment or radiotherapy, or within 4 weeks of radiotherapy completion or primary cytoreductive surgery
* Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale) (Patients in the ovarian basket will not be required to meet fatigue criteria in order to be enrolled. Patients in the ovarian basket will be eligible for enrollment prior to commencement of chemotherapy)
* Karnofsky score 60 or greater
* Life expectancy greater than six months
* English speaking

Exclusion Criteria:

* Cognitive impairment that would preclude response to study assessments or require the use of Legally Authorized Representatives
* Unwilling to accept random assignment
* Concurrently enroll onto ongoing competing trials of integrative medicine interventions with symptom/toxicity as primary outcome. Note, however, patient will be allowed to enroll on other therapeutic protocols
Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF

This study evaluates the clinical effect of regenerative endodontic procedure using PRF in immature permanent teeth with apical periodontitis. Half of participants will receive the PRF instead of blood clots in the regenerative endodontic procedure, while the other half will receive a blood clots in the regenerative endodontic procedure.

The conventional method of regenerative endodontic procedure using a blood clot as scaffold materials has shown successful results. However, it is very difficult to induce bleeding and place mineral trioxide aggregate over a blood clot. Platelet-rich fibrin (PRF), a second-generation platelet concentrate. PRF is a matrix of autologous fibrin containing a large quantity of platelets, growth factors and leukocytes. PRF preparation technique is very simple, inexpensive and doesn't require any chemical agents. The purpose of this study is to test the hypothesis that the use of PRF in regenerative endodontic procedure of immature permanent teeth with apical periodontitis will accelerate periapical bone healing and stimulate the root maturation.

Eligibility Criteria:
Inclusion Criteria:

* Between 6 and 18 years of age
* Provision of Informed Consent
* Cooperative in the dental chair
* Permanent immature teeth with apical periodontitis and incomplete root development

Exclusion Criteria:

* Have a medical history that may complicate treatment
* Unlikely to be able to comply with the study procedures
A Study to Collect Information About HIV-Positive Pregnant Women and Their Babies

The purpose of this study is to collect medical information about HIV-positive pregnant women and their babies who have been (or are being) seen at study sites. This information will be used to help design future research studies for these patients.

The population of HIV-positive pregnant women and their babies who are seen at study sites has not been officially examined. In order to design future studies to research the best care for these patients, this study will examine important characteristics and the general number of women in these trials.

The population served at affiliated ACTG sites has not been officially described. Anecdotal evidence, however, has surfaced regarding the characteristics of HIV-infected pregnant women and the current standard of care during pregnancy. This chart abstraction study is designed to define, more accurately, the pertinent characteristics and general numbers of women in these trials.

In this medical chart abstraction study, pertinent information is collected on all HIV-infected pregnant women and their infants who receive primary or consultative care at PACTG 367 study sites. Part A profiles all HIV-infected women who received care or consultation at study sites and who had a pregnancy outcome between January 1, 1998 through July 1, 1998. \[AS PER AMENDMENT 04/12/02: Part A is closed to enrollment.\] Part B profiles HIV-infected pregnant women who receive primary or consultative care and a pregnancy outcome following July 1, 1998.

Eligibility Criteria:
Inclusion Criteria

A patient may be eligible for this study if she:

* Is an HIV-positive woman.
* Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available.
* Had a baby on or after January 1, 1998.
Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

This study is being conducted to study light scattering properties of maternal-fetal tissue.

The ISS customized commercial frequency domain oximeter is used to obtain light scattering information from the maternal abdomen for 10-20 minutes preoperatively and postoperatively in subjects who are having a scheduled C-section.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with singleton pregnancies, vertex or breech presentation, scheduled for non-emergent cesarean delivery, including cesarean delivery for failure to progress with reassuring electronic fetal heart rate tracing
2. Age greater than or equal to 18 years of age.
3. Healthy women at equal to or greater than 36 weeks gestation undergoing non-emergency cesarean delivery
4. Spinal or epidural anesthesia

Exclusion Criteria:

1. Emergency cesarian delivery
2. Non-reassuring fetal heart rate tracing
3. Less than 18 years of age
4. Multiple gestation (twins, triplets)
5. Presentation other than vertex or breech
6. Less than 36 weeks of gestation
7. General anesthesia