cyrilzakka/clinical-trials huggingface dataset:
The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda

The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control.

The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart.

In Uganda, schistosomiasis affects approximately 10% of the population and transmission takes place along all large water bodies (rivers and lakes).

Morbidity control should aim at increasing the length of time before morbidity reappears and decrease the time during which morbidity regresses in a situation with continued transmission and re-infection. It is proposed to test this by comparing the standard treatment with a double treatment (2 x 40 mg/kg) two weeks apart.

The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control.

The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart. Two groups of participants, with 270 people in each, will be randomly selected and randomly assigned to the two treatment regimens. Three consecutive stool samples will be from the cohort and blood samples for malaria will be examined. Clinical and ultrasonographic examinations will be performed. After all the examinations, the whole cohort will be treated with a single standard dose of praziquantel and albendazole. Two weeks later all members of one of the groups will receive another standard dose of praziquantel. Follow-up examinations will be performed 8 weeks, 6 months and two years later.

Eligibility Criteria:
Inclusion Criteria:

* age \> 7 years Residence in project village

Exclusion Criteria:

* persons treated with praziquantel within 2 weeks before recruitment
Cannabidiol for the Treatment of Pelvic Pain in Endometriosis (DREAMLAND)

The objective of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabis extract in women with endometriosis who have already undergone hormonal contraceptive treatment and surgery without satisfactory response.

The Dreamland study is a two-arm, parallel-group, individually randomized (1:1 allocation ratio), controlled by disease stage, participant and investigator blinded, single-site superiority trial of oral cannabis extract (CBD). CBD will be given orally starting at 10 mg daily and up-titrated to a maximum dose of 150 mg daily. Dose up-titration will be based on clinical response or side effects, whichever comes first. After 63 days of treatment, gradual withdrawal will be performed during one week. Then, at 70 days, there will be an open-label extension wherein all participants from control group will be offered a course of CBD according to the same previous protocol.

This research intends to :

1. Assess whether the daily use of CBD, for nine weeks, will reduce the pain level of these women.
2. Assess whether the daily use of CBD, for nine weeks, will modify pain threshold.
3. Assess whether the daily use of CBD, for nine weeks, will interfere in psychological symptoms.
4. Assess the possible adverse effects of using CBD

Eligibility Criteria:
Inclusion Criteria:

* Women with chronic pelvic pain secondary to endometriosis surgically treated, with refractory symptoms, and who are taking complementary hormone therapy;
* Women over 18 years of age who wish to participate in the clinical trial;
* Willingness to voluntarily participate in the study to accept randomization to either of the two treatment arms;
* Participating exclusively in this clinical trial during the study period;
* Possess a telephone (cell or landline) that may be available to receive daily calls throughout the study period;
* Signature of the Free and Informed Consent Term (TCLE) approved by the Local Research Ethics Committee.

Exclusion Criteria:

* Chronic, severe or uncompensated medical conditions, such as: insulin-dependent diabetes (types 1 or 2); uncontrolled high blood pressure, lung disease such as asthma or other chronic obstructive pulmonary disease; hematological diseases, liver diseases, chronic kidney disease in advanced stage (grade 3, 4 and 5), metabolic disturbances and immunosuppression;
* Use of any medication with potential interaction with CBD/THC (such as chloroquine, clobazan, warfarin, or valproic acid) or history of undesirable reactions prior to the use of this medications;
* Inability to use oral medication;
* Pregnancy or lactation;
* History of alcohol or drug addiction;
* Smoking in the last three years;
* Marijuana use in the past three months or a lifetime history of dependence;
* Inability to cooperate with investigators due to cognitive impairment or mental status.
An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)

Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel disease. A successful recanalization of foot artery was related to a higher ulcer healing and a reduction of major amputation. Moreover absence of revascularization in a patient with critical limb ischemia is an independent risk factor for mortality. Despite the introduction of new devices dedicated to below the knee vessel disease treatment, with the development of guides and conical balloons, long term patency outcomes are still poor. Restenosis was observed in more than two thirds of patients within 3 months after angioplasty of tibial arteries with a high target lesions revascularization. These re-interventions are characterized by a higher morbidity and mortality due to several comorbidities associated to these patients. These data confirm the need to obtain more lasting results in order to improve long-term outcomes of these patients.

Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty have shown controversial results.

The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb ischemia.


Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria :

* Age ≥18 years and ≤85 years
* Patient signed an approved consent form
* Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6
* Menopausal or under contraception for women
* Negative serum β-HCG for women of childbearing age

Angiographic Inclusion Criteria :

* Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main below the knee vessels
* Intraluminal recanalization of the target lesion with successful traversal of the target lesion and placement of the guidewire into the distal true lumen
* Reference vessel reference diameter comprised between 2 and 4 mm

Exclusion Criteria:

General non-inclusion criteria:

* Patient with known hypersensitivity to paclitaxel
* Patient unwilling or unlikely to comply with Follow-Up schedule
* Life expectancy \<1 year (investigator's appreciation)
* Planned major index limb amputation
* Pregnant or breast feeding women

Angiographic exclusion criteria:

* Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, superficial femoral or popliteal artery that cannot be treated successfully in the same session
* Previously implanted stent in the target lesions(s)
* Aneurysm in the target vessel
* Acute thrombus in the target limb
* Failure to cross the target lesion
Predictors of Outcome in t-PA Treated Stroke.

Stroke is among the most disabilitating diseases worldwide in terms of numbers affected and its consequences. A relatively new and well documented treatment of acute ischemic stroke today is tPA (tissue plasminogen activator; will be called thrombolysis from now on) Unfortunately only a minority of patients is given this treatment.

The large randomised controlled trials that investigated the safety and efficacy of thrombolytic therapy in treatment of acute stroke did not include patients over 80 years. In an aging population in the western world it will be of importance to investigate whether this treatment is safe and effective in this group.

Both Sorlandet hospital Kristiansand Norway and Bergen hospital have administered thrombolysis to selected patients over 80 years the last years. In addition there has been a registration of patients in stroke registers at both locations. This lays a foundation for further investigation. In association with Bergen the investigators have included 77 patients over 80 years treated with thrombolysis. In addition the investigators have 85 patients treated with tpa below 80 years. In our cohort the investigators are going to compare outcome in the 2 groups. In addition the investigators are going to perform a regression analysis of selected variables to see if there is an association of those variables with predefined outcome measures. Our outcome measures is as follows: mRS=6 (death)and mRS 0-1(good outcome) on 3 months control. The third outcome measure will be developement of sICH secondary to tPA treatment. As definition of sICH we have chosen the same definition as Ecass.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke treated with thrombolysis over 80 years between 01.01.2007-28.02.2010 from predefined centers.
* Patients with acute ischemic stroke treated with thrombolysis at Sorlandet hospital Kristiansand below 80 years in the same defined period.

Two patients were excluded due to missing data at three months control
The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms

Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
* Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels \>40 mIU/mL.

Exclusion Criteria:

* History of a seizure disorder other than a single childhood febrile seizure.
* History or presence of clinically important hepatic or renal disease or other medical disease.
* Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
Mixed-species Biofilms and Silicone Device Longevity

The purpose of this study is to determine whether the mix of microbial species isolated from biofilm-clogged voice prostheses is specific to each participant, whether the microbes are orally-derived and whether the presence of specific species is a predictor of the frequency with which patients discard devices due to malfunction. The microbes isolated from discarded devices will be used to test the antimicrobial properties of newly-developed medical silicones.

This study has three primary objectives and one secondary objective:

Primary Objectives

* To understand variation in the composition of mixed-species biofilms on voice prostheses, both between patients and over time within patients. This will enable us to target resistance to specific microbes using chemistry-based approaches in the design of new medical silicones and develop realistic in vitro models using relevant clinical isolates with which to test them.
* To explore the association between the incidence of specific microbes in biofilms, patient factors (use of antimicrobials, antacids and dentures), and increased device-replacement frequency.
* To explore whether the colonising microbes originate from the participants's oral flora.

Secondary Objective

• To study the interactions that occur within the social group of microbes isolated from each voice prosthesis to learn a) whether these species are interdependent, b) whether they cooperate with each other in order to build biofilms and b) which species produce compounds that physically degrade medical polymers.

STUDY DESIGN

Four hypotheses will be addressed by this study:

1. There is a correlation between the presence of certain microbes, or mixes of microbes, and the frequency of device replacement;
2. The source of the problem microbes is the participants's oral flora;
3. Participant-related factors such as continuous exposure of the microbes to antimicrobial or antacid treatments, or the use of dentures, may alter the composition of device biofilms.
4. Identification of problem microbes may assist in the development of new medical silicones that are specifically designed to resist these species.

These hypotheses will be addressed by collection of discarded devices from participants who are users of voice prostheses and registered at the Speech and Voice Clinic, Aberdeen Royal Infirmary (up to 27 people). Participants will be requested to donate discarded devices, mouthwash samples and simple data on recent antimicrobial or antacid treatments, and the use of dentures. The microbes colonising prostheses and contained within mouthwash samples will be isolated and identified and the association between microbial species and patient data over time will be analysed. Microbes will be stored as clinical isolates and used to test biofilm establishment and maintenance on silicones with modified surfaces designed to reduce biofouling.

Eligibility Criteria:
Inclusion Criteria:

* Total larygectomy patients.
* Must be registered at Speech and Voice Clinic, Aberdeen Royal Infirmary

Exclusion Criteria:

* Under 18 years of age
Abnormal Coronary Vasomotion in Patients With Suspected Coronary Artery Disease (CAD)

In patients with chest pain and/or shortness of breath coronary artery disease (CAD) is suspected depending on the pattern of symptoms and the electrocardiogram (ECG). Coronary angiography is the method of choice to verify this suspicion. If the patient coronary arteries on coronary angiography are totally normal or unobstructed, one can only speculate if the patients' discomfort is from the heart or not. A possibility to get further information about the healthiness of the coronary arteries is the acetylcholine test (ACH-test). When injecting this natural, body produced-substance into the coronary arteries one can test if the vessels develop coronary spasm which can be the reason for the patient's symptoms. The investigators therefore use this test in this study to look for coronary spasm in patients with suspected CAD but normal/unobstructed coronary arteries. In case of a positive test, the patient profits from having found a cause for his/her symptoms making treatment with special tablets possible. Furthermore, the investigators want to analyze blood samples of every patient to look for signs of inflammation, vasoconstriction and genetic variants that seem to be linked with coronary spasms. On the basis of these results the ACH-test could probably be avoided in the future.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 35 and 95 years old with angina pectoris and/or dyspnea suggestive of coronary artery disease with non-invasive proof of coronary ischemia or high pre-test probability for CAD who will be referred for coronary angiography
* Serum creatinine \< 1,4 md/dl
* Left ventricular ejection fraction \> 50%

Exclusion Criteria:

* Patients under 35 years and above 95 years of age
* Severe chronic obstructive pulmonary disease (contraindication for acetylcholine-testing)
High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

The study will compare two different size MRI's of a brain tumor.

The study is designed to directly compare the MR images of a brain tumor obtained on the 3T and then 7T MRI in approximately 150 patients followed serially with MR imaging to evaluate for tumor progression.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or older
* Patient must meet at least one of the four following criteria regarding brain tumor diagnosis:
* Histological diagnosis of a brain tumor
* Histological diagnosis of systemic cancer and brain MR imaging suggestive of metastatic disease to the brain
* Pre-operative brain MR imaging suggestive of a brain tumor
* Radiographic diagnosis of brain tumor in an inoperable location (e.g., brainstem)
* Patient able and willing to provide informed consent
* Karnofsky Performance status \> 70%
* Life expectancy greater than 3 months
* Negative serum or urine pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
* Patients who are excluded from 7T MR imaging because of titanium implants that are not yet established to be safe at 7T remain eligible for the imaging at 3T \* Spanish speaking participants will be enrolled for this study

Exclusion Criteria:

* Body weight \>137 Kg (300 lbs)
* Patient unable to provide informed consent
* Karnofsky Performance status \< 70%
* Patients who are claustrophobic or have other contraindications to MRI, such as implanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants
* NYHA class III and IV congestive heart failure
* Psychiatric or addictive disorders that preclude obtaining informed consent
* Unstable angina
* Sexually active patients of childbearing potential not using a reliable contraceptive method
* Pregnant or lactating women
* Women of childbearing potential who refuse a pregnancy test (performed during screening)
Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction

This study aimed to determine the therapeutic effectiveness of different machines in intense pulsed light (IPL) treatment of meibomian gland dysfunction (MGD). Subjects diagnosed with MGD underwent three sessions of IPL treatment in a control (M22) treatment group or experimental (OPL-I) treatment group and were followed up three to four weeks after each session. Tear breakup time (TBUT), meibomian gland secretion scores (MGSS), meibomian gland meibum scores (MGMS), corneal fluorescein staining (CFS) scores, and the Standard Patient Evaluation of Eye Dryness (SPEED) was used to assess eye dryness signs and symptoms at baseline and follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

1. Fitzpatrick skin type I-IV according to sun sensitivity and skin appearance
2. A Standard Patient Evaluation of Eye Dryness (SPEED) score of ≥6
3. Tear breakup time (TBUT) of ≤10 s in the studied eye
4. Corneal fluorescein staining (CFS) score of ≥1 (it is not necessary to consider this criterion if the TBUT is ≤5 s)
5. Meibomian gland secretion score (MGSS) of ≥6 in the studied eye.

Exclusion Criteria:

1. Use of prescription eye drops (excluding artificial tears) within 48 hours of recruitment
2. Facial IPL treatment within the prior 12 months
3. Any surgery of the eye or eyelids within the prior six months
4. Ocular surface and eyelid abnormalities
5. Any systemic condition that might cause eye dryness
6. Use of photosensitive drugs within the prior three months
7. Precancerous lesions
8. Skin cancer or pigmented lesions in the treatment area
9. Overexposure to the sun within the previous month
10. Ocular infections within the previous six months
11. Uncontrolled infections or immunosuppressive diseases
Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA.
* Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio \> 0.9
* Patient is 18 years of age or older

Exclusion Criteria:

* tPA use within 14 days prior to baseline CTA
* Systolic BP \< 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg
* Pulmonary hypertension with peak PA \> 70 mmHg by right heart catheterization
* History of severe or chronic pulmonary hypertension
* Fi02 requirement \> 40% or \>6 LPM to keep oxygen saturations \>90%
* Hematocrit \< 28%
* Platelets \< 100,000µL
* Serum creatinine \> 1.8 mg/dL
* INR \> 3
* aPTT (or PTT) \> 50 seconds on no anticoagulation
* History of heparin-induced thrombocytopenia (HIT)
* Contraindication to systemic or therapeutic doses of anticoagulants
* Major trauma \< 14 days
* Presence of intracardiac lead
* Cardiovascular or pulmonary surgery within last 7 days
* Cancer requiring active chemotherapy
* Known serious, uncontrolled sensitivity to radiographic agents
* Life expectancy \< 90 days
* Female who is pregnant
* Intracardiac Thrombus
* Patients on ECMO
* Current participation in another investigational study