cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia

The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in Colombia. The benefit will be assessed in terms of:

* Efficacy
* Tolerability
* Time of fever clearance
* Time of parasite clearance
* Proportion of gametocyte carriers


Eligibility Criteria:
Inclusion Criteria:

1. pure P. falciparum infection
2. parasitaemia \>500 and \<50,000 asexual parasites/μL (subsequently the lower limit was modified to \>250 asexual parasites/μL)
3. age between 1 and 65 years old
4. availability to return for follow-up

Exclusion Criteria:

1. Pregnancy
2. history of allergy to the study drugs
3. history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week
4. have a medical history of untreated hypertension or chronic heart, kidney or liver disease
5. present any danger signs of severe malaria.
A Randomized Controlled Trial to Assess the Role of Emergent vs Early Endoscopy in Child B and C Cirrhotic Patients With Acute Variceal Bleed (AVB)-EARLY - AVB

Summary-Variceal bleeding - 70% of all upper gastro-intestinal bleeding episodes in patients with portal hypertension, and they result from esophageal varices (EVs), gastric varices (GVs), or ectopic varices.

Management of Acute variceal bleeding includes endoscopic variceal ligation (EVL) along with vasoactive agents. Inspite of successful hemostasis, this is associated with high variceal rebleeding (VRB) in Child B and C cirrhosis and have higher 6-week mortality rates and liver related adverse events. From time of presentation to emergent endoscopy that is 4 hours can reduce the mortality when compared early endoscopy within 4-12 hours so that mortality rate related to bleed can reduced and early hemostasis can be achieved.

1. Aim and Objectives -To assess the role of Emergent Endoscopy vs Early endoscopy in patients with Acute variceal bleed in CHILD B\&C Cirrhosis.
2. Hypothesis - Early use of endoscopy along with adequate resuscitation and medical optimization in patients with Child B/C cirrhosis would lead to higher rates of endoscopic hemostasis thereby associated with better clinical outcomes, in terms of in hospital mortality rate and Liver failure related mortality in post bleed, recurrent bleeding rates.

Study population- Patient presenting with AVB as per definition in Child B \&C cirrhotics.

Study design- Randomized Control Trial Non Inferior Trial. Study area- ILBS , Delhi Intervention: Patient after screening for all exclusion criteria will be randomized into either Emergent endoscopy or Early endoscopy

Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will undergo the Endoscopy procedure.Post procedure patient will be followed and evaluated for rebleed, mortality, liver related events if any like Hepatic encephalopathy, Ascites, Ischemic hepatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Child B and C cirrhotic patients with history of AVB
2. \>18YRS and \<75 yrs.
3. Fluid responsive within 1 hour after resuscitation

Exclusion Criteria:

1. EHPVO / NCPH
2. Lack of consent Pregnancy
3. Child A cirrhotics
4. Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours).
5. Need of Dual vasopressors at presentation In Hospital patients with Bleed
6. HCC patients with AVB
7. Patients presented with AVB on going antiplatelets/anticoagulants.
Evaluation of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers

This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females between the ages of 18 and 70 years
* Body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
* Females could not be pregnant or breast feeding and had to be using birth control

Exclusion Criteria:

* Positive drug screen for substances of abuse
* Positive results for HIV, hepatitis B, or hepatitis C
* Screening 12-lead ECG demonstrating QTc interval \>430 msec for males and \>450 msec for females, or any cardiac rhythm disorder considered by the Investigator to be clinically relevant
Fibroblast Growth Factor 23 in Chronic Respiratory Failure

Fibroblast growth factor 23 (FGF23) is a key hormone of the mineral metabolism produced in bone and acting on the kidney to lower phosphatemia. FGF23 is subject to inactivating proteolytic cleavage which results in the presence of C-terminal and N-terminal fragments heretofore described as inactive.

We recently showed an increase in FGF23Ct in sickle cell patients, its association with left ventricular mass as well as a direct, pro-hypertrophic effect of FGF23Ct on rat cardiomyocytes. Data from the literature suggest that hypoxia (linked or not to anemia) is responsible for an increase in the production and cleavage of FGF23, either via the hypoxia inducible factor (HIF1α) or via the increase in erythropoietin (EPO).

We hypothesize that the FGF23Ct / FGF23i ratio is increased in response to chronic tissue hypoxia, in the absence of anemia, in patients with chronic respiratory failure (CRF) either due to a direct response to hypoxia via the stimulation of HIF1α, or indirectly via the increase in the circulating concentration of EPO. This elevation, if proven, could contribute to the increased risk of heart disease seen in some populations of CRF.

We propose to test this hypothesis by assaying FGF23Ct and FGF23i in a cohort of adult CRF patients before and after initiation of oxygen therapy.

The object of the present study is to study the FGF23Ct / FGF23i ratio in incident patients presenting with a non treated CRF as well as the modifications of this ratio under oxygen therapy and to study the correlations between FGF23 Ct and FGF23 and i) oxygen saturation and PaO2 ii) echocardiographic parameters and iii) EPO concentrations.

Three visits are planned: Baseline (before initiation of oxygen therapy), and two visits after initiation of oxygen therapy, at 3 months (M3) and at 12 months (M12).

For each visit, anthropometric and clinical data, treatment and biological results will be collected. FGF23 intact , FGF23 C-terminal and Erythropoietin will be measured. A cardiac ultrasound will be performed at baseline and at M12.


Eligibility Criteria:
Inclusion Criteria:

* Patient informed and not opposed to participating in the research
* Age ≥ 18 years old
* Severe chronic respiratory failure defined by PaO2 \<60 mmHg, whatever the cause, and justifying the initiation of long-term oxygen therapy
* Not yet treated or with stopping oxygen therapy for at least 6 weeks
* Be affiliated with a social security scheme or be a beneficiary of such a scheme
* Be able to understand the interest and the constraints of the study

Exclusion Criteria:

* Exacerbation of respiratory failure in the 6 weeks prior to inclusion
* Chronic kidney disease defined by a glomerular filtration rate (GFR) estimated by CKD-EPI \<60 mL / min / 1.73m2
* Anemia at the time of inclusion whatever the cause (sickle cell anemia, thalassemia, hemolytic anemia, chronic iron deficiency, others)
* Pregnancy
* Breastfeeding women
* Simultaneous participation in another therapeutic trial
* Patient under guardianship or curatorship
* Patient under medical help from the French government
Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer

Fatigue is one of the most common and distressing symptoms in teenage and young adult cancer patients. Despite this, there has been virtually no research evaluating treatment for cancer-related fatigue in this young patient group. The investigators are undertaking a small qualitative study to co-design a fatigue intervention, that will then be evaluated in future research to assess its effectiveness.

This small qualitative study will involve 7-10 patients who are within one year of completing cancer treatment, as well as some parents. Participants will be recruited from one centre, the Cambridge Teenage and Young Adult cancer Principal Treatment Centre. The three phases will involve a) participants being interviewed individually and attending a focus group, b) patients receiving the prototype co-designed intervention, and c) participants being interviewed after the intervention to provide feedback to allow further refinement of the intervention. The intervention will be delivered by an Allied Health Professional in the setting that participants have chosen. It is likely to involve, at a minimum, education about fatigue and support with increasing activity. It will not include administration of any medication.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Aged 16-27 with a diagnosis of cancer
* Currently or previously known to the Cambridge Teenage and Young Adult cancer service
* Primary cancer treatment completed within one year of recruitment OR on maintenance treatment for leukaemia.
* A screening score of ≥5 in a 10-item numerical rating scale of fatigue severity over the last month
* Able to give informed consent

Parents:

* The parent of a patient participant or a patient who would be eligible to participate
* The patient consents to the parent being approached about the study
* The parent is able to give informed consent

Exclusion Criteria:

* Current participation in another clinical trial
The Effect of Final Exam Preparation on Anxiety Level, Self-Perception, Ocular Symptoms, Accommodation and Vergence in Myopia

To evaluate the effects of exam preparation on anxiety level, self perception, ocular symptoms and oculomotor responses in myopes

Twenty two first year optometry students were evaluated towards the end of their first academic year on a battery of Oculomotor and Survey tests. This occurred during two sessions, one Low Stress session and one High Stress session. Sessions were separated by one month.

Low Stress Session (LS), No Exams or Minor Exams High Stress Session (HS), Final Exam Preparation week

Battery of Surveys:

Adult Manifest Anxiety Scale for College Students (AMAS-C):

36 items which probe 4 types of anxiety

* Worry/Oversensitivity
* Test Anxiety
* Physiological Anxiety (Somatic responses to anxiety)
* Social Concerns

Self Perception Profile (SPP):

45 items which probe 9 domains

* Scholastic Competence
* Social Acceptance
* Athletic Competence
* Physical Appearance
* Job Competence
* Romantic Appeal
* Behavioral Conduct
* Close Friendship
* Global Self-worth

CI Symptom Survey (CISS-15):

15 items which probe ocular and aesthenopic signs and symptoms

Students also reported Hours of daily near work (NWhrs).

Battery of Oculomotor Tests:

(20/30 ETDRS target used for all) Vergence Tests

* Phorias Near and Far (Neutralized Alternate Cover Test)
* Vergence Ranges Near and Far (Prism Bar)
* Vergence Facility Near and Far (3BI/12BO)
* Near Point of Convergence

Objective Accommodative Tests (SRW-5000autorefractor)

Monocular Accommodative Responses to:

* Near Target (33cm)
* Minus Lens (-3D) while viewing distant (6m) target

Subjective Accommodative Tests:

Monocular Accommodative Responses to:

* Donder's Push Up Amplitude test
* Near Accommodative Facility (+/-2.00, five practice trials)
* Distant Accommodative Facility (plano/-2.00, five practice trials)

Eligibility Criteria:
Inclusion Criteria:

* Any first year optometry student

Exclusion Criteria:

* Previous Refractive surgery, amblyopia, strabismus, RGP wearer
Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia

It will be hypothesized that strengthening the calf muscles will improve standing efficiency in children with spastic diplegia.


Eligibility Criteria:
Inclusion Criteria:

* Children age will be ranging between 2 and 4 years.
* They are classified at level III by GMFCS-ER, i.e. they can stand with minimal support.
* Full mobile lower limbs joints.
* Children with mild and moderate spasticity ( i.e. grade 1 and 2, according to Modified Ashworth Scale).

Exclusion Criteria:

* Children with severe spasticity ( i.e. grade 4, according to Modified Ashworth Scale).
* Fixed deformities.
* Uncontrolled seizures.
Investigating Proximal Muscle Strength Effects by Incorporating Proximal Muscle Lengthening

The purpose of this study is to assess strength gains of proximal musculature in the nondominant upper extremity after implementing blood flow restriction (BFR) and myofascial release (MFR) with the supplementation of whey protein.

The purpose of this study is to assess strength gains of proximal musculature in the nondominant upper extremity after implementing blood flow restriction (BFR) and myofascial release (MFR) with the supplementation of whey protein. Blood flow restricted (BFR) exercise is the brief and non-continuous blockage of venous blood flow using a device that restricts the flow of blood while exercising. This technique is used to produce hypertrophy (muscle growth) and strength responses while exercising at a lighter load than traditionally required to produce a similar response. Myofascial release (MFR) is a technique that involves applying gentle sustained pressure into the myofascial connective tissue restrictions to eliminate pain and restore motion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the age of 18 and 30

Exclusion Criteria:

* Individuals with uncontrolled high blood pressure
* Individuals with sickle cell anemia, current pregnancy
* Individuals with a history of deep vein thrombosis
* Individuals with diabetes
* Individuals with active infection
* Individuals with less than normal range of motion or muscle strength
* Individuals with moderate to severe upper extremity injury in the past 12 months
* Individuals with a current diagnosis of cancer.
Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch

This study is aimed to compare the results and operating characteristics of liver stiffness measurement with the use of Fibroscan (EchoSens, France) and iLivTouch (Wuxi Hisky Medical Technologies Co., China) in patients with chronic liver diseases.

This is prospective comparative trial to assess diagnostic characteristics of non-invasive methods of liver fibrosis and steatosis assessment based on the measurement of liver stiffness. The null hypothesis is that novel device, iLivTouch FT100/FT200 and standard probe allows to obtain similar results of liver stiffness and controlled attenuation parameter compared to FibroScan 530 and probes M+ and XL+ in patients with chronic liver diseases. According to the study protocol, standard examination will be performed to eligible subjects on the same day with the use of both devices. At least 10 measurements will be performed with the use of each device to each subject after overnight fasting. The medians of liver stiffness and controlled attenuation parameter measurements, their interquartile range, success rate of measurements and related interpretations of the results (grades of liver fibrosis and steatosis) will be compared. To assess the variability of the results, demographic data (age, biological sex, ethnicity) will be collected; weight and height of the subjects will be measured on the day of examination. Medical history of the subjects will be examined to extract data, confirming the presence of chronic liver diseases and ensure eligibility.

Eligibility Criteria:
Inclusion Criteria:

* willingness to participate on the basis of the signed informed consent form;
* availability of the medical records

Exclusion Criteria:

* pregnancy and breastfeeding;
* narrow intercostal spaces making standard examination of the liver stiffness possible;
* extreme obesity, in cases when amount of the fat tissue in right lower part of chest makes impossible to perform measurements;
* ascites;
* focal lesions of the liver (including, but not limited to liver cancer or metastases of cancer regardless of their origin, parasitic invasions, cysts) in projection of the measurements;
* impossibility to perform evaluation with both devices due to any reasons;
* any health-related conditions of a subject that put him/her at risk in case the procedures required per study protocol are performed or making him/her ineligible on the discretion of the investigator
Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation

This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D\&E) to paracervical block.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 and older
* Intrauterine pregnancy ≥16 weeks gestation
* English speaking competency
* Willing and able to sign consent forms
* Agree to comply with study procedures

Exclusion Criteria:

* Women less than 18 years of age
* IV conscious sedation
* Known allergy to study medication (lidocaine)
* Any women not meeting inclusion criteria above will be excluded from participation
A Hospital-Based Registry of Preventive Cardiology Clinics

More research is needed to articulate the most effective ways to use these tools as screening tests in cardiovascular risk assessments and how they ultimately affect CVD mortality and morbidity outcomes. Clinicians are encouraged to continue sharing decision-making with patients to combine their unique cardiovascular risk factors and develop a comprehensive, effective treatment plan.

Study Design: observational study Duration of Study: ongoing. Sample Size: All patients presenting to preventive cardiology clinics at the National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan..

Sampling Technique: Non-probability consecutive sampling Data Collection Procedure: Verbal informed consent will be obtained from all the patients regarding their participation in the study and publication of study findings while maintaining confidentiality. Consecutive patients presenting preventive cardiology clinics at the National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan, will be included in this registry. Demographic characteristics, physical examination, clinical history, risk modification, lab assessment, and ASCVD risk score at presentation and at every follow-up will be recorded using a structural questionnaire.

Data Analysis Procedure: The Tentative analysis plan uses collected data for research publications. The statistical package for social sciences (SPSS 21) will be used to analyze baseline characteristics. The Shapiro-Wilk test will be applied to check the hypothesis of normality for quantitative (continuous) variables. Descriptive statistics such as mean ± SD, median (IQR), skewness, maximum, and minimum will be calculated for quantitative (continuous) variables. Frequency and percentages will be calculated for categorical variables.

Eligibility Criteria:
Inclusion Criteria:

* All individuals attending the preventive cardiology clinics.

Exclusion Criteria:

* • Individuals who refused to give consent.
Preventing the Obturator Nerve Reflex

The key objective of this study is to compare success rates of ultrasound guided obturator nerve block and anatomic landmark guided obturator nerve block as determined by neuromonitoring endpoints and surgeon observations.

Transurethral resection of bladder tumor (TURBT) is a urologic surgery used in the treatment of non-muscle invasive bladder cancer. A potential complication of this procedure is bladder rupture or injury secondary to adductor muscle contraction from obturator nerve stimulation. This risk is increased in resection of lateral wall tumors, as electrosurgical resection of these lesions is more likely to inadvertently stimulate the obturator nerve.

There are several mechanisms for preventing the obturator reflex. Pharmacologic paralysis can reliably inhibit thigh adduction. However, TURBT is often a short procedure that is not amendable to intermediate duration neuromuscular blocking medications. The use of succinylcholine is another option but is limited by its short duration of action which may not be adequate for the time needed to resect the tumor. Additionally, many patients have contraindications to the use of succinylcholine. Spinal anesthesia does not reliably prevent the obturator reflex.

Regional anesthesia is another potential treatment modality to prevent the obturator reflex during TURBT. Motor blockade of the obturator nerve will prevent this adduction in the event of inadvertent nerve stimulation. Peripheral blockade of the obturator nerve can be combined with either general or spinal anesthesia. Historically, obturator nerve block (ONB) has been considered a technically challenging procedure. Recently, however, successful ultrasound guided ONB techniques have been reported. To the best of our knowledge there has been no study to date comparing the effectiveness of ONB achieved by anatomic landmarks (with nerve stimulation) versus ultrasound guided ONB (with nerve stimulation) at preventing the obturator reflex during TURBT surgery.

The key objective of this study is to compare success rates of ultrasound guided obturator nerve block and anatomic guided obturator nerve block as determined by neuromonitoring endpoints and surgeon observations.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing TURBT for lateral wall bladder tumors at risk for electrical stimulation as determined by the attending surgeon.

Exclusion Criteria:

* Pre-existing obturator nerve injury
* Thigh adductor muscle weakness
* Neuropathy
* Local anesthetic allergy
* Infection at the site of injection
* Abnormal coagulation studies
* use of neuromuscular blocking medications (if deemed necessary by attending anesthesiologist caring for the patient).
A Meta-analysis of Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease

A meta-analysis to compare outcomes of drug eluting stents (DES) versus bare metal stent (BMS) in saphenous vein graft (SVG) disease.

To compare outcomes (death, myocardial infarction, target vessel revascularization) of drug eluting stent versus bare metal stent in saphenous vein graft disease.

Eligibility Criteria:
Inclusion Criteria:

* CABG disease
* randomized studies
* not randomized studies

Exclusion Criteria:

* studies reporting composite and not single endpoints, duplicate reporting
Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM

The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in patients with tuberous sclerosis complex or lam.

The study design was an open label, phase I/II trial of sirolimus for one year followed by one year off therapy.Patients were seen at baseline,at two weeks to four weeks, and at 2,4,6,9,12,18 and 24 months. Angiomyolipomata imaging was performed at all but the two to four week visit. Complete pulmonary function tests and six-minute walk were obtained at baseline,6 or 9 month, 12 and 24 month visits, while simple spirometry only was performed at all other visits.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with angiomyolipomas and have either Tuberous Sclerosis complex or Lymphangioleiomyomatosis
* Between the gaes of 18 and 65 years
* Competency to voluntarily consent
* Clinically definite diagnosis of tuberous sclerosis or S-LAM
* Adequate contraception
* At least one angiomyolipoma of 1 cm or greater in largest diameter

Exclusion Criteria:

* Use of continuous supplemental oxygen
* Concurrent infection
* Recent surgery
* Ongoing or planned pregnancy
* Lactation
* Use of an investigational drug within the last 30 days of study entrance