cyrilzakka/clinical-trials huggingface dataset:
Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment

Objective and Hypotheses: This project has the overall objective of implementing and evaluating new approaches to reducing the current and future burden of urinary schistosomiasis in young children using the antihelminthic drug Praziquantel. The project aims to (1) determine the operational health benefits of treating schistosome infections early on re-infection and morbidity reduction, (2) determine if gut or urine microbiome structure (species diversity or abundance) is a risk factor for S. haematobium infection or morbidity, and (3) elucidate the factors and underlying mechanisms mediating the reduction/reversal of schistosome-related morbidity and resistance against infection/re-infection in young children.

This study aims to refine current paediatric treatment of schistosomiasis using the drug Praziquantel (PZQ) to improve the current and future health of pre-school children and infants. Praziquantel is cheap, highly efficacious and safe, presenting a realistic opportunity of using a pre-existing tool in a modified way to benefit child health and development. The study will focus on children aged 3 to 5 years of age, comparing the impact of early vs. later treatment with PZQ on the current and future health status of the children. By killing worms PZQ stops the morbidity related to the presence of worms and eggs such as anaemia, abdominal pain, diarrhoea and blood in the urine as well as induced immune responses associated with reduced re-infection rates. Therefore the study will investigate the immediate health benefits of treating pre-school children and infants and the effects of treatment on re-infection rates.

Eligibility Criteria:
Inclusion Criteria:

1. lifelong residents of the area
2. have provided at least 2 urine and 2 stool for parasitological examination
3. have given a blood sample before and after each treatment episode
4. be negative for schistosomes, hookworm, Trichuris and Ascaris
5. have frequent contact with infective water

Exclusion Criteria:

1. clinical signs of tuberculosis or malaria
2. presenting with fever
3. have had a recent major operation, illness or vaccination
4. have previously received antihelminthic treatment
5. are infected with any helminths
Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes

This trial is conducted in Oceania.

The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Current treatment with any insulin in any regimen
* Body mass index (BMI) below 38.0 kg/m2
* HbA1c below or equal to 13.0%

Exclusion Criteria:

* Total daily insulin dosage more than 100 IU/day
* Current acute or chronic pulmonary disease (excluding asthma)
* Recurrent major hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment
* Smoker
* Chest X-ray with clinically significant abnormalities
Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.

This is a safety study.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.
* Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.
* Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.

Exclusion Criteria:

* PANSS score \>70 at Screen or Baseline Visit.
* Subjects hospitalized within the past six months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past six moth.
* Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or Baseline Visit.
* Subjects taking Bupropion.
Study of Herbal Formula Corresponding to Syndrome in Treating Post Percutaneous Coronary Intervention (PCI) Patients With Coronary Heart Disease (CHD)

We conduct this clinical trial to determine the effects of Xuefu Zhuyu capsule (based on TCM "Zheng Hou" theory) in helping recovery from coronary heart disease(CHD)after PCI and find out whether this kind of effecacy is much better within patients administered with TCM syndrome-based individualized medication.

The effectiveness of a Chinese herbal formulae is not completely based on the disease or some biomedical indexes, but much more on the TCM syndrome(Chinese name:Zheng Hou)which is generalized from patients' TCM signs and symptoms. Thus, conventional medical curative effecacy evaluation system seems not to so fit for TCM clinical studies. Although many clinical studies from Chinese literature have reported the beneficial effects of various of TCM herbal agents in improving symptoms and signs as well as antagonism of specific pathological changes in CHD patients, most of these trials are lack of well-designed methodologies and the reliability of results still remains unclear. Therefore, we designed this clinical trial, with a randomized, placebo controlled way, to evaluate the curative effects of Xuefu Zhuyu capsule(a Chinese herbal medicine)in patients with Post-PCI CHD patients and find out whether this effects will be better displayed within subjects administered with syndrome-based individualized medication.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Clinical diagnosis of coronary heart disease (confirmed by coronary angiography)
* Successfully received interventional therapy (PTCA or PCI)
* belong to TCM blood-stasis syndrome
* Must be able to swallow tablets
* Able to give written informed consent

Exclusion Criteria:

* Symptomatic congestive heart failure(New York Heart Association class III-IV)
* Females during pregnancy or lactation
* Serious dysfunction in important organs (liver, lung, kidney，et al)
* Use of concomitant Chinese herbal medicine
* Already attend other clinical trial
Occupational Hand Eczema - Testing of a Prevention-concept

Randomised controlled trial examining the effect of decreased waiting time for the first doctors' appointment, patient education, glove counselling and counselling at departments of social or occupational medicine on severity of hand eczema, quality of life, use of corticosteroids, and jobsituation 3-12 months after intervention in patients with suspected occupational contact dermatitis of the hands.

Patients with suspected occupational hand eczema are recruited to the study on basis of their referral from general practitioner to dermatologist. Patients are randomised to either control or intervention group. The control group is treated and followed-up by the dermatologist they have been referred to, while the intervention group is treated and followed-up at Gentofte Hospital skin department with a maximum waiting time of 3 weeks. At the skin department at Gentofte Hospital, the patients in the intervention group receive patient education in prevention and treatment of hand eczema, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema. Patients in both the control and intervention group are asked to fill out a questionnaire at 3, 6, 9 and 12 months after inclusion in the study. The questionnaire contains questions about quality of life, severity of hand exzema, jobsituation, use of healthcare service and use of medicine. Furthermore, prescriptions of medicine are registered in both control and intervention group at 3, 6, 9 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Referred from a general practitioner to a dermatologist
* Hand eczema within the last 3 months
* Suspicion that the hand eczema is work-related (either patient and/or doctors suspicion)

Exclusion Criteria:

* Does not read and write danish
* Severe psychiatric illness
* Pregnancy
E3 Diabetes - Closing the Gap in Diabetes Control

This study aims to decrease the racial gap in type 2 diabetes control in African American and Latinx patients in Rush University Medical Center clinics.

Cardiovascular disease (CVD) is the leading cause of death in the US as well as in Chicago. Risk factors for CVD include hypertension, diabetes, and lifestyle factors such as smoking, diet, and obesity. Among the critical social and structural determinants of cardiovascular health are food access, neighborhood safety, education, poverty, and chronic stress. Chicago and its surrounding region suffer from longstanding racial disparities in both social conditions and chronic disease burden, contributing to stark racial gaps in cardiometabolic disease mortality. Life expectancy is as high as 84 years on Chicago's North Side, but only 68 years on the West Side - a gap of 16 years. Cardiometabolic disease accounts for 40 to 50% of this lifespan gap. The diabetes-related death rate is 70% higher among Chicago's African Americans than among non-African Americans. In Rush primary care clinics, under conditions of usual clinical care, African American and Latinx patients with diabetes have worse glycemic control than white patients, raising the question whether modifying the model of diabetes care from intermittent clinic-based care to more frequent home-based care remote monitoring might reduce these stubborn disparities. We are proposing a feasibility trial of a remote diabetes monitoring, social care, medication adherence and dietary intervention to improve diabetes control among African American and Latinx patients attending primary care clinics at Rush University Medical Group locations with the eventual aim of closing the racial/ethnic disparity in diabetes control. The proposed feasibility trial will use a randomized-control, four-pronged approach to improve glycemic control. The intervention group will receive the following: 1) remote glucose monitoring, 2) a multidisciplinary team to address social needs, 3) medication titration and adherence support, and 4) culturally tailored diabetes self-management and dietary education. The control group will receive standard of care diabetes primary care in addition to dietary education around diabetes through written materials. We hypothesize that E3 Diabetes program participants will achieve a change in A1c of 0.5 in at least 30% of the participants in 6 months, and will be a greater percentage than seen with the propensity matched control of African American and Latinx patients receiving usual care for Diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and older
* African American and/or Latinx
* Uncontrolled Type 2 Diabetes, A1C \>/= 8.0 within the last 3 months
* Following with Rush primary care provider in eligible Rush primary care clinics
* Access to cellphone

Exclusion Criteria:

* Patient has Type 1 Diabetes
* Patient is already participating in another remote diabetes monitoring program
* Patient is not interested in participating in the program
* Patient has already participated in the E3 hypertension program
A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment

This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of OAB for 3 months or longer
* At least 1 urgency episode in last 3 days
* Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

  * a. Number of micturition ≥8 times/day
  * b. Number of urgency episodes in 3 days ≥3

Exclusion Criteria:

* Significant stress incontinence or mixed stress/urge incontinence
* Subject with indwelling catheters or practicing intermittent self-catheterization
* Symptomatic urinary tract infection, chronic inflammation
* Diabetic neuropathy
* Subjects who are prohibited from taking solifenacin as contraindications
* Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
* Participation in any clinical trial in 30 days except for Part-1 of RESORT
* Diabetic neuropathy
3TC (Lamivudine; GR109714X) Open-Label Program

To make lamivudine (3TC) available to patients with progressive, symptomatic HIV disease who cannot participate in a controlled clinical trial and who are refractory or unable to tolerate other therapies. To collect data pertaining to the safety of 3TC at two dose levels. To evaluate the effect of 3TC on markers of hepatitis B in co-infected patients at five to ten selected sites.

Patients 12 years and older are randomized to receive one of two doses of 3TC for a duration determined by the patient's physician or until termination of the program. Patients \< 12 years receive a lower dose of 3TC. Patients are followed monthly. For selected sites only, serum samples are collected every 3 months from patients identified as HBsAg positive.

PER 02/28/95 AMENDMENT: Patients enrolled prior to 3/1/95 may remain on their assigned monotherapy dose or change to combination therapy with 3TC and zidovudine.

Eligibility Criteria:
Patients must:

* Have progressive, symptomatic HIV disease.
* Have a mean CD4 count \<= 99 cells/mm3 for adults and \<= 300 cells/mm3 for children (original design was CD4 count \<= 300 cells/mm3 for both adults and children).
* Be unable to participate in a controlled trial.
* Be refractory to or unable to tolerate other therapies.
* Be able to attend clinic on a monthly schedule.
* Have consent of parent or guardian if under the age of consent.

NOTE:

* If a pregnant or breast-feeding woman requests enrollment, her physician should contact Glaxo staff directly to discuss the case.

Practice of unsafe sex.
Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings

This randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings.

This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. The app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. All participants will be assessed at study intake and every month during the 3-month intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Opioid use disorder
* Eligible for buprenorphine treatment
* Has reSET-O compatible mobile device

Exclusion Criteria:

* Pregnancy
* Significant psychiatric comorbidity
Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men

The study compares the effects of ultrasound lipolysis and cryo lipolysis on cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, body mass index, skin thickness, waist circumference, and waist hip ratio in centrally obese middle aged men. It also investigates the impact of ultrasound lipolysis on skin thickness, waist circumference, and waist hip ratio.

Obesity has become a key risk factor for the development of cardiovascular diseases and dyslipidemia. Overweight and abdominal obesity has increased in men more than in women.

For young individuals, intra-abdominal fat is the important component of the body fat for six of the eight metabolic risk factors. Intra-abdominal fat might contribute to that most patients with acute myocardial infarction at a young age are men.

Abdominal lipolysis by ultra sonic is a safe and efficacious method and can effectively decrease waist circumference, waist hip ratio and blood cholesterol.

Adding cryolipolysis to a low-calorie diet is protocol from other methods to improve the body profile, in form of body mass index, waist-to-hip ratio, as well subcutaneous fat tissues thickness, but also leads to improvement in lipid profile and liver enzymes

Eligibility Criteria:
Inclusion Criteria:

1. Obese men with middle age range will be 40-60 years.
2. Obese men with central obesity.
3. Body mass index (BMI) greater than 30 Kg \\m2.
4. Waist circumference will be \>94 cm.
5. Waist to hip ratio more than 0.9

Exclusion Criteria:

1. Chronic respiratory disorders and cardiovascular problems.
2. Diabetic patients.
3. Presence of skin diseases in abdominal regions that prevent the use of ultra sound or cryolipolysis therapy.
4. Men with kidney or liver diseases.
5. Tumor diseases
6. Lesions of higher center leading to obesity.
7. History of active or chronic infectious, autoimmune disease.
8. History of abdominal surgeries.
Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.

Past research suggests that over 75% of alcohol dependent individuals in early alcohol recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in this population. Many alcohol dependent individuals in early recovery are interested in smoking cessation treatment; however, studies indicate that these smokers find it very difficult to quit smoking. More effective treatment methods are needed for smokers in early alcohol recovery. Bupropion is a dopaminergic antidepressant that may be effective in treating nicotine dependent individuals. The purpose of this study is to evaluate the effectiveness of bupropion in nicotine dependent individuals receiving treatment for alcohol dependence. In addition, this study will investigate the psychological mechanisms that may mediate the efficacy of bupropion in smoking cessation. We will also collect DNA from subjects in order to explore whether response to bupropion is mediated by particular genetic variants in the dopaminergic, metabolic and nicotinic receptor systems of smokers.

Participants will be randomly assigned to receive either 300 mg of bupropion or placebo, daily for 8 weeks. In addition, all participants will receive a nicotine patch for 7 weeks. This will consist of a 21-mg nicotine patch for 4 weeks, a 14-mg nicotine patch for 2 weeks, and a 7-mg nicotine patch for 1 week. All participants will undergo seven counseling sessions. Follow-up visits will occur at Weeks 7, 12, and 24. Pre-quit variables (e.g., smoking satisfaction) and three post-quit variables (craving, nicotine withdrawal, and negative effects) will be evaluated at all study visits.

Eligibility Criteria:
Inclusion Criteria:

* Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry
* Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at time of study entry
* Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry

Exclusion Criteria:

* History of seizures, head trauma and/or severe hepatic cirrhosis
* Current use of medications known to affect smoking behavior and/or cessation
* Use of tricyclic antidepressant medication and monoamine oxidase inhibitors
* Major depressive disorder within the month prior to study entry
* Eating disorder within the year prior to study entry
* History of bipolar or psychotic disorder
* Pregnant or breastfeeding
* Unstable serious medical disorder
* History of migraines
* Currently using smokeless tobacco, pipes, or cigars
Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage

Decompressive craniectomy has been reported for the treatment of patients with aneurysmal subarachnoid hemorrhage (aSAH). But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy combine aneurysm clipping surgery or endovascular coiling will improve clinical outcomes of poor-grade aSAH patients.

Aneurysmal subarachnoid hemorrhage (aSAH) is a worldwide health burden with high fatality and permanent disability rates. Decompressive craniectomy, which is beneficial in patients with malignant middle cerebral artery infarction, may indirectly relieve the mass effect, decrease perihematomal tissue pressure, improve blood flow, reduce secondary brain damage and improve outcome without further damage to the brain due to surgery. Early therapy with either surgical clipping or neuroradiologic intervention with endovascular coiling is the primary treatment for aSAH. But whether decompressive craniectomy should be employed during the clipping surgery or immediately after coil embolization still have considerable controversy. 80 patients will be recruited to the trial over 12 months. Follow-up will take 6 months with analysis and reporting taking 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18yrs and age\<60yrs
* It shows subarachnoid hemorrhage (SAH) based on computed tomography (CT) scan on admission
* Aneurysmal subarachnoid hemorrhage confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
* Presentation to our institution in World Federation of Neurological Societies (WFNS) Grade III to V neurological condition with Lateral hematoma
* Duration from onset to admission is within 48 hours

Exclusion Criteria:

* Traumatic subarachnoid hemorrhage
* Patients with cerebral herniation or highly possible to occur before surgery
* Neurosurgery contraindicated
* Patients with obvious evidence of acute hydrocephalus on admission
* Intracranial aneurysm combined with cerebral arteriovenous malformation
* Patients with obvious evidence of irreparable brainstem or thalamic injury
* Duration from onset to admission is more than 48 hours
* Disturbance of communication or poor compliance to blood collection, imageological examination and follow-up