cyrilzakka/clinical-trials huggingface dataset:
A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania

HIV antiretroviral therapy (ART) has the potential to dramatically decrease HIV transmission worldwide. In Tanzania, HIV prevalence is \~5%, with 1.6 million people living with HIV/AIDS; it is the leading cause of hospitalization and death among Tanzanian adults. However, less than 50% of HIV-infected Tanzanian adults know their status.Successful implementation of community-based services requires an understanding of the social and cultural context that influence community engagement with HIV services. Specifically, many HIV endemic regions are also medically pluralistic communities, where multiple explanatory frameworks for health and disease co-exist. In these areas, HIV testing and ART clinical care do not occur in isolation; traditional healers are commonly utilized instead of or concurrently with biomedical services. Therefore, the success of decentralized, community-based HIV services must be founded upon a thorough understanding of medical pluralism, and engagement with traditional healers as stakeholders in community health.

This study will investigate the feasibility of involving traditional healers in HIV testing, and pilot an intervention to expand HIV testing within communities that use traditional medicine in Mwanza, Tanzania.

This study has two specific aims.

Specific Aim 1:

Tailor a point of care HIV testing intervention for delivery in northwestern Tanzania, using data from 1) qualitative interviews and 2) community engagement strategies. Interviews with traditional healers, traditional and biomedical clients, and HIV clinic staff will illustrate local variables impacting HIV testing engagement. A community advisory board with stakeholder members will guide program implementation, tailoring protocols to maximize uptake.

Specific Aim 2:

Conduct a cluster-randomized pilot of the HIV testing intervention. This pilot will offer HIV testing at five traditional healer practice sites, compared with a control group of five healers providing education on community HIV resources..

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Not known to be HIV-infected
* Client of a traditional healer practice
* Willing to be contacted for monthly follow-up for three months
* Willing to complete an exit survey at the end of three months
* Able to provide informed consent

Inclusion specific to point-of-care HIV testing intervention:

* Willing to have point of care HIV test
* Willing to receive results of HIV test

Exclusion Criteria:

* less than 18 years of age
* Known to be HIV-infected
* Unable to provide informed consent
* Unwilling to participate in follow-up

Exclusion specific to point-of-care HIV testing intervention:

* Unwilling to have point-of-care HIV test
* Unwilling to receive the results of HIV test
Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

Patients diagnosed with posterolateral bladder tumors will be invited to participate in the study. Subjects will be randomized to receive an ultrasound-guided obturator block or a neuromuscular blocking agent after the induction of general anesthesia in an attempt to block the obturator reflex during surgery.

The purpose of this research is to compare the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents versus obturator block. Transurethral resection of bladder tumor(s) (TURBT) is a commonly performed procedure to diagnose and treat bladder cancer. The obturator nerve is located lateral to the bladder wall in the pelvis prior to innervating the adductor muscles of the thigh. Depending on the location of the tumor(s), electrocautery or surgical stimulation may result in stimulation of the obturator nerve, resulting in adduction of the leg, which is called the adductor reflex or spasm. This may occur violently and unexpectedly, and result in bladder perforation, bleeding, or cancer dissemination.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Planned TURBT for unilateral or bilateral posterolateral bladder tumors
* Ability to understand and provide informed consent

Exclusion Criteria:

* Patient refusal or inability to provide informed consent
* True allergy, not sensitivity, to local anesthetics
* True allergy, not sensitivity, Propofol
* True allergy, not sensitivity, general anesthetic agents
* Pregnancy
* Severe hepatic impairment
* Evidence of infection at or near the proposed needle insertion site
* Any sensorimotor deficit of the lower extremity, whether acute or chronic
* Inability to walk without assistance
* Lower extremity joint replacement surgery in the preceding six months
A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction

This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.


Eligibility Criteria:
Inclusion Criteria:

* Methamphetamine dependence
* Treatment seeking
* Urine sample (+) for methamphetamine

Exclusion Criteria:

* Pregnancy
* Dependence on other drugs (except nicotine)
* DSM-IV axis I disorder unrelated to drug abuse
* Serious medical condition in clinicians opinion.
* AIDs
* Untreated syphilis
* Allergy to acamprosate
* Methadone, or other ORP, maintenance
Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection

Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.


Eligibility Criteria:
Inclusion Criteria:

Subject has signed informed consent Subject is an adult older than 18 yrs old and requires an upper endoscopic evaluation If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.

Patient has not received prior treatment for H pylori Subject is able to understand and comply with study procedures

Exclusion Criteria:

Recent use (within 4 weeks) of any of the medications used in the treatment of H pylori(Amoxicillin, Clarithromycin, Metronidazole) Subject undergoing endoscopy for acute gastrointestinal bleeding Subject has an allergy to any of the medications used in the treatment of H pylori Subject has a history of esophageal or gastric carcinoma including lymphoma Subject has esophageal varices or undergoing endoscopy for esophageal banding Subject is taking warfarin or clopidogrel Subject has coagulopathy that precludes safe biopsy of the biopsy areas Subject has comorbidity that precludes safe participation in the study Subject is a pregnant female Subject has a history of H. pylori infection. Patient is already enrolled in GI Study. History of UGI surgery other than Nissen Fundoplication
Effect of Ultrasound Cavitation Versus Electrolipolysis on Obese Infertile Women With Polycystic Ovarian Syndrome

This study aims to determine the difference between the effect of ultrasound cavitation and electrolipolysis on obese infertile women with polycystic ovarian syndrome.

Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy among women during reproductive age . PCOS affects 5-10% of women in reproductive age. It has an effect on quality of life , fertility and pregnancy.

Obesity plays a significant role in reproductive disorders, particularly in women. It is associated with anovulation, menstrual disorders, infertility, difficulties in assisted reproduction, miscarriage, and adverse pregnancy outcomes.

The treatment of obesity and infertility causes some harm to women, due to the danger of some operations and medications other than the high cost of these operations, so it is necessary to use a therapeutic alternative that is non invasive, with lower risk and lower cost.

Both ultrasound cavitation (UC) and electrolipolysis are non invasive modalities with many positive effects on obesity and PCOS outcomes. The effect of both the UC and electrolipolysis has been separately investigated in previous studies. Though, no studies were found to compare the effect of both modalities in the management of infertile women with PCOS. Therefore, this study will be conducted to explore the effect of UC versus electrolipolysis on infertile women with PCOS.

Eligibility Criteria:
Inclusion Criteria:

* Infertile married PCOS women, diagnosed by Rotterdam criteria .
* Their ages will be ranged between 25-35 year old.
* Their BMI will be ranged from 30-40 kg/ m2.
* Their waist/hip ratio equal to or more than 0.85

Exclusion Criteria:

* Thyroid dysfunction (hypothyroidism).
* Chronic and/or systemic illnesses (e.g. diabetes mellitus, liver, renal respiratory failure and cardiovascular disorders).
* Malignant tumors.
* Tubal adhesions as well as uterine abnormalities.
* Skin diseases in the abdominal and gluteal regions.
* Conditions that may prevent the use of electrical stimulation.
A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides

This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.


Eligibility Criteria:
Major Inclusion Criteria:

* Provision of written informed consent prior to any study-specific procedure
* Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements
* Fasting triglyceride \<400 mg/dL following wash-out of all lipid regulating medications and supplements
* BMI between 18 and 35 mg/kg2

Major Exclusion Criteria:

* Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
* Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)
OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry

Prospective, observational, multicenter, national study of adult patients with HF to assess prescription and adherence to evidence-based Guideline-Directed Medical Therapy (GDMT) in patients with Heart Failure (HF).

Prospective, observational, multicenter, national study designed to evaluate the care and outcomes of patients with HF, to understand reasons for lack of implementation of evidence-based treatment and the impact of adherence to treatment on clinical outcomes in patients with HF across the full spectrum of left ventricular ejection fraction (LVEF).

The study will enroll consecutive patients with symptomatic HF, aged ≥ 18 years from at least 30 Italian tertiary HF care centers. Both outpatients and in-patients with chronic and acute decompensated HF will be consecutively recruited. Patients will be followed for a maximum duration of 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Signed patient informed consent form (ICF)
* Diagnosis of chronic or acute decompensated HF according to ESC guidelines and the universal definition of HF.
* Receiving at least one drug for management of HF at study enrollment (including diuretics, β-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosterone antagonists).

Exclusion Criteria:

* Planned participation or participation in a clinical trial;
* Life expectancy \< 1 year because of non-cardiac causes;
* Previous heart transplant or left ventricular assist device implantation.
Early Vitrectomy for Impending Macular Hole

This study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole.

In a study conducted 15 years ago, the 'Vitrectomy for Prevention of Macular hole Study Group' was not able to prove the benefits and advantages of vitrectomy for impending macular hole; however, during the interim period, notable improvements have been achieved with regard to diagnosis and efficacy of treatment.

Therefore, we designed this study to identify the effect of current vitreous surgery for symptomatic impending macular hole.

Characteristics of this study is as below

* Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole occurs)
* Non-randomized study (decision was made by patients after full explanation)
* After 1 year follow up, functional change(visual acuity)and anatomical change(development of full-thickness macular hole) would be evaluated

Eligibility Criteria:
Inclusion Criteria:

* male or female with impending macular hole(identified with OCT)
* Age: over 45 years
* Symptom duration \< 6 Months
* Visual acuity on trial: less than 73 letters in ETDRS chart Visual acuity of worsened eye: over 24 letters in ETDRS chart

Exclusion Criteria:

* Any vision disturbing disease other than impending macular hole
* Diabetic maculopathy or other retinal vascular disease
* Prior history of major trauma: If symptom begins after trauma
* Myopia over -6.5Dioper or eyes with axial length \> 28mm
* Evidence of scar, degeneration or exudation of macula
* active intraocular inflammation
* History of intraocular surgery other than uncomplicated cataract extraction 3months before
* Uncontrolled IOP \> 25mmHg
A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe

The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects

Exclusion Criteria:

* Clinically significant diseases or disorders
* Positive screens for drug and alcohol
* Pregnant or breast-feeding females
* Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption
Multimodal Imaging in Rectal Cancer & Pancreatic Cancer

Most digestive cancers show (over)expression of the tumour marker carcinoembryonic antigen (CEA). Therefore, interest in CEA-targeting tracers has increased over the past years. CEA-targeting tracers can be used for preoperative, intra-operative and postoperative imaging purposes. This study focusses on both preoperative and intraoperative multimodal imaging and image-guided surgery in patients with rectal cancer or pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rectal cancer where a (beyond) TME resection is planned for OR Clinical suspicion of PDAC
* Scheduled for surgical resection
* Age over 18 years
* Signed informed consent

Exclusion Criteria:

* Any medical condition present that in the opinion of the investigator will affect patients' clinical status
* Administration of a radionuclide within 10 physical half-lives prior to study enrollment
* Pregnancy or lactation
* Known CEA negative tumor: If a patient had a primary tumor which did not express CEA determined immunohistochemically on the resection specimen of a prior operation or biopsy.
Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas

The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas (HNSCC). Dual-energy computerized tomography could easily replace a standard CT neck with the added benefit of providing functional information that would only be possible with advanced computerized tomography perfusion, magnetic resonance diffusion (MRI) or positron emission tomography (PET) imaging techniques.

Patients with head and/or neck tumors routinely have head and neck imaging completed with a computerized tomography scan, commonly called a CT scan. A CT scan combines a series of x-ray views that are taken from many different angles and uses computer processing to create cross-sectional images inside your body. These cross-sectional images are very thin slices, often less than 1 mm thick and allow the radiologist to examine parts of your tissue very closely.

Dual energy computed tomography (DECT) is a fairly new technology that uses both the normal x-ray and also a second less powerful x-ray to make the images. The Ottawa Hospital has scanners in use that are able to take the images that oncologists typically order for patients and can also be set to obtain DECT images at the same time.

The purpose of this study is to investigate whether DECT images can provide helpful information to better predict how the tumor will respond to treatment and the likely course of head and neck tumors.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* untreated, histologically confirmed head and neck squamous cell carcinoma

Exclusion Criteria:

* paranasal sinus involvement of head and neck squamous cell carcinoma
A Clinical Trial of BAT8001 on Safety, Tolerability and Pharmacokinetics for Patients

An Open-Label, Dose Escalation Phase I Clinical Trial on Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients with HER2-Positive Solid Tumors (breast cancer or gastric cancer)。

This is an open-label, dose escalation Phase I clinical study in two stages. Stage 1 consists of the first four cycles where the tolerability, safety, pharmacokinetics and immunogenicity of BAT8001 for injections will be studied and preliminary efficacy will be evaluated. Efficacy and safety assessments continue from the fifth cycle until disease progression or intolerable toxicities.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced solid tumors refractory to standard treatment or of intolerable or no standard treatment.
2. Patients with breast cancer or gastric cancer (including gastroesophageal junction adenocarcinoma) histopathologically or cytologically diagnosed and tested HER2-positive (IHC 3+ and/or ISH+);
3. At least one measurable lesion according to RECIST version 1.1;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Absence of severe hematopoietic abnormalities, and basically normal heart, lung, liver and kidney functions;
6. Expected survival ≥ 3 months;
7. Left ventricular ejection fraction (LVEF) by ultrasound examinations higher than the lower limit of normal range defined by the study site;
8. The cumulative dose of anthracyclines should meet the following: the cumulative dose must not exceed the equivalent dose of 360 mg/m2 doxorubicin.

Exclusion Criteria:

1. Have active hepatitis B virus or hepatitis C;
2. Patients who are positive for the human immunodeficiency virus;
3. Patients with a history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation;
4. Patients with clinically significant active infection as determined by the investigator;
5. Other concurrent, severe or uncontrollable systemic diseases (such as clinically significant metabolic disorders, poor wound healing, ulcers, etc.);
6. Moderate or severe dyspnea at rest caused by advanced malignant tumors or complications or serious primary lung diseases, or currently requiring continuous oxygen therapy, or currently having interstitial lung disease or pneumonia;
7. Cardiac insufficiency within the past 6 months before enrollment based on the following definitions: Grade ≥ 3 symptomatic congestive heart failure (CHF) according to CTCAE v4.03, or a history of Grade ≥ 2 symptomatic congestive heart failure, transmural myocardial infarction, unstable angina according to New York Heart Association (NYHA) Functional Classification, or severe arrhythmia without proper medicinal control, severe heart block, uncontrolled hypertension, or clinically significant cardiovascular disease;
8. Patients with central nervous system or brain metastasis symptoms, or who have received treatment for central nervous system or brain metastasis within 3 month before the first dose;
9. Grade ≥ 2 peripheral neuropathy ;
Spinal Anaesthesia and Severe Preeclampsia

The use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as these patients present particular hazards with general anaesthesia, such as concerns for rapid airway control and cerebral blood flow alterations during induction of general anaesthesia and intubation However, the incidence of hypotension is high during spinal anesthesia for Cesarean section and it may approach values up to 95 %.

The parturient will be allocated into one of two equal groups (n=30), a severe preeclampsia group (A) and a normotensive group (B). All will receive colload (500 ml voluven) as a coload via wide bore (16 Gauge ) cannula within 5-10 minutes during induction of spinal anesthesia. Standard monitoring with electrocardiography, automated non-invasive arterial pressure (NIAP) measurement, and pulse oximetry will be performed. Systolic arterial pressure (SAP), mean arterial pressure (MAP) and diastolic arterial pressure (DAP) will be monitored. Baseline values will be recorded in the supine position. Central venous line will be inserted in severe preeclampsia group and central venous pressure will be measured every 10 minutes.

Spinal anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 40 years
* Severely Pre-eclamptic females, severe pre-eclampsia is defined as hypertension( BP \> 159/109) ,proteinuria ( urinary protein excretion of greater than 5 gm per day) and oliguria(\<500 ml in 24 hours) with at least one maternal organ dysfunction .

Exclusion Criteria:

* Age : \<18 years
* Obese patients with BMI \> 35 Kg/m2
* Preterm delivery
* Patients with contraindication to spinal anesthesia.
* Patients in active labor