cyrilzakka/clinical-trials huggingface dataset:
A 14 Day Early Bactericidal Activity Study of Nitazoxanide for the Treatment of Tuberculosis

This research is being done to determine if Nitazoxanide (NTZ) will cause a significant decrease in the number of M. tuberculosis bacteria in sputum after 14 days of treatment. The study is being conducted at the GHESKIO Centers in Port au Prince Haiti

This is a prospective randomized two-arm 14-day, early bactericidal activity study in treatment-naive, drug-susceptible patients with uncomplicated pulmonary tuberculosis (TB). The study will be conducted at the GHESKIO Centers in Port au Prince Haiti. Twenty patients will be randomized to receive NTZ 1 gram orally twice daily for 14 days. Ten patients will be randomized as positive controls to receive standard 4 drug tuberculosis therapy with isoniazid (H), rifampin (R), ethambutol (E), and pyrazinamide (PZA). Patients' sputum will be collected before and then every two days during 14 days of treatment, and the primary endpoint will be the change in the number of M. tuberculosis in patients' sputum. Our primary hypothesis is that NTZ will result in a significant decrease in the number of M. tuberculosis in sputum during14 days of treatment. The number of M. tuberculosis will be quantified by the time to positive (TTP) signal in hours in an automated liquid media culture system (BACTEC MGIT 960, Becton Dickinson).

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 - 65
* Diagnosed with pulmonary tuberculosis via: sputum-microscopy smear-positive (2+ or 3+) within 14 days plus Sputum GeneXpert positive within 14 days plus Chest radiograph consistent with M. tuberculosis within 14 days
* TB treatment naïve at time of enrollment
* Bodyweight \> 40kg
* Negative HIV test within 30 days
* Able to complete activities of daily living (ADLs)
* All participants must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization)
* All female participants must agree to use barrier methods such as condoms as well as hormonal contraception for dual prophylaxis.
* Able to give informed consent and demonstrate understanding of this study and willingness to participate in this study
* Willing to be hospitalized for 2 weeks

Exclusion Criteria:

* Pregnancy
* Evidence of complications of M. tuberculosis such as hemoptysis or shortness of breath
* Extrapulmonary manifestations of M. tuberculosis
* History of prior active tuberculosis
* Evidence of rifampin resistance via GeneXpert
* Previous diagnosis of diabetes or suggestion of impaired glucose metabolism via random plasma glucose
* Previous diagnosis of HIV by any rapid HIV test or by ELISA
* Any of the following lab abnormalities: Creatinine \> 1.5 times the ULN; Random glucose \> 2 times the ULN; ALT, AST, or alkaline phosphatase \> 2 times the ULN; Hemoglobin \< 7.5 g/dL
* Any participant currently taking antimycobacterial therapy or within the past 30 days
* Any concomitant illness that could compromise patient safety in this trial such as renal failure, chronic liver disease or alcoholic dependency
* Enrolled in another clinical trial
Effect of Topical Nepafenac 0.1% on Pain Related to Intravitreal Injections

The analgesic effect of Nepafenac 0.1% Ophthalmic Drops on ocular pain related to intravitreal injections will be evaluated.

Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.

Intravitreal injection (IVI) is a preferred route of administration of drugs in the posterior segment of the eye. Intravitreal injection of anti-VEGFs constitutes the mainstay for the treatment of various retinal diseases such as AMD, RVO, DME etc.

The procedure of the IVI is, however, associated with a level of discomfort for the patient.

Ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) constitute an established and effective treatment option for the management of inflammation and pain associated with cataract surgery and of pain associated with corneal refractive surgery, for inhibition of intraoperative miosis and for the treatment of seasonal allergic conjunctivitis.

The primary goal of this study is to assess the analgesic effect of Nepafenac 0.1% Eye Drops a topical NSAID on pain related to intravitreal injections immediately after and up to six hours post-IVI.

A number of patients scheduled to undergo IVIs will be divided in two groups. All patients must have already undergone at least one IVI. In patients receiving IVIs in both eyes only one eye will be included in the study.

The patients of the first group will be randomized to receive Nepafenac 0.1% Eye Drops in the first appointment and then crossover to receive the placebo (Artificial Tears) in their next appointment for an IVI.

The patients of the second will be randomized to receive the placebo (Artificial Tears) in the first appointment and then crossover to receive Nepafenac 0.1% Eye Drops in their next appointment for an IVI.

All drugs will be administered prior to the injection by a member of the Department's personnel (a staff nurse).

Patients will be required to complete the greek version of the short form McGill Pain Questionnaire (SF-MPQ) comprising of the Visual Analogue Scale, the main component of the SF-MPQ and the Present Pain Intensity Scale immediately after the injection and 6 hours post-IVI.

Eligibility Criteria:
Inclusion Criteria:

* All participants will be patients of the Medical Retina Department of our Clinic, who are scheduled to receive IVIs of ranibizumab (Lucentis; Novartis Pharma S.A.S., Huningue, France) or aflibercept (Eylea; Bayer Healthcare Pharmaceuticals, Berlin, Germany) in one eye and had already undergone at least one IVI of an anti-VEGF agent.

Exclusion Criteria:

* History of previous eye surgery other than cataract extraction surgery, herpetic eye disease, uncontrolled glaucoma, uveitis, active conjunctivitis, keratitis and bullous keratopathy, a previously known allergic response to bromfenac or other NSAIDs and salicylates, any systemic or topical use of NSAIDs or any use of sedative medications within 7 days from the visit and during the day of IVI.
* Patients with poor cooperation in understanding and answering the questions of the SF-MPQ, including the visual analogue scale (VAS).
* Unsuccessful blinding
Single Rising Dose Study of BI 201335 ZW in Healthy Male Subjects

The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW following administration of single rising doses from 5 mg to 1500 mg. In addition Two stage intra-subject bioavailability comparison of 600 mg BI 201335 ZW as a liquid formulation given with and without food.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs ((blood pressure (BP), pulse rate (HR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
* Age ≥18 and Age ≤55 years
* BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
* Willingness to abstain from alcohol from screening period until conclusion visit

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range and of clinical relevance
* History of any familial bleeding disorder
Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh

This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.

A randomised double-blind controlled intervention of 36 weeks duration was conducted in a rural community located 40kms north-west of Dhaka, the capital of Bangladesh. Infants aged between 3 and 11 months were randomly assigned to either receiving anti-Giardia and antihelmintic treatment, or anti-Giardia treatment only, or a control group receiving placebos. Weight and supine length were recorded every 4 weeks. Every 12 weeks intestinal permeability (L/M ratio), haemoglobin, plasma albumin, alpha-1-acid glycoprotein, immunoglobulin G and Giardia intestinalis specific IgM titre (GSIgM) and eggs of the three common geohelminths and Giardia intestinalis cysts were determined.

Eligibility Criteria:
Inclusion Criteria:

* infants living in the study area
Health in Motion- A Pragmatic Clinical Trial- Home

Falls among older adults are a serious public health concern and injuries resulting from falls can cause significant loss of independence, premature death, and higher caregiver burden. Home-based fall prevention programs, such as the Otago Exercise Program, educate older adults about the importance of identifying fall risk and provide strategies for reducing fall risk; however, many are costly and are not scalable, accessible, or sustainable. This project will evaluate the use of a digital solution that translates evidence-based fall prevention programs (such as Otago Exercise Program and Matter of Balance) to a digital solution (Health in Motion Fall Prevention Platform), as an alternative to home-based fall prevention programs that is affordable, scales to the millions of older adults across the country at risk for falls and is sustainable for the older adult's life.

This study will involve 2 groups. Both groups will be followed for 12 months. The investigators will use a comparative prospective longitudinal (12-months) observational cohort study to compare the Health in Motion Fall Prevention Program with a no-intervention group. Metrics of effectiveness include the rate of falls, fall risk, fear of falling, and falls efficacy. Economic benefit will be measured using the EQ-5D-5L, along with hospital and clinical visits. The primary outcome is the incidence of falls (rate in person-months).

Eligibility Criteria:
Inclusion Criteria:

* age of 55 and older
* if history of 2 or more falls in the past year with a physician or physical therapist approval
* Score \>31 on the TICS (Telephone Interview for Cognitive Screen)
* Easy for Me screen for inclusion

Exclusion Criteria:

* any person who has been told by their physician that they should not exercise
Antioxidants in Gestational Diabetes

Fasting and two hours postprandial blood sugar were done to all cases between 28 and 32 weeks and high blood sugar levels were found so Cases were controlled by both diet and insulin.

The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet \& insulin). Group2 received only the treatment of diabetes

The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid oral once daily (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet \& insulin). Group2 received only the treatment of diabetes (diet and insulin

Eligibility Criteria:
Inclusion Criteria:

* Women with the diagnosis of GDM

Exclusion Criteria:

* Women with multiple pregnancies
* Chronic medical disorders e.g. anemia
* Hypertension
* Liver disease or renal disease
* Those with obstetric problems other than GDM (e.g. pre-eclampsia \& antepartum hemorrhage) or smokers and women with preexisting type I or II diabetes mellitus were excluded from our study
IMFINZI Specific-Clinical Experience Investigation in Patients With NSCLC After Definitive Chemoradiation Therapy

To investigate the impact of presence/absence or grade of radiation pneumonitis before starting IMFINZI, on the onset of interstitial lung disease (including radiation pneumonitis) after starting IMFINZI, in the real world in patients with locally advanced unresectable non-small cell lung cancer who are treated with the product as maintenance therapy after definitive chemoradiation therapy.


Eligibility Criteria:
Inclusion Criteria:

-Patients with locally advanced unresectable non-small cell lung cancer who are treated with IMFINZI for the first time as maintenance therapy after definitive chemoradiation therapy

Exclusion Criteria:

-No past history of hypersensitivity to the components of IMFINZI
Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

The purpose of this study is to compare intravenous furosemide (125 to 250 mg), isolated or in combination with hypertonic saline solution (2.6% to 3.4%) in the outpatient heart failure patient. The hypothesis is that the combination therapy will increase the diuresis volume at 3 hours and improve congestion parameters at 7 days.

This is a randomized, double-blind, multicenter study of all consecutive patients with decompensated heart failure and signs of volume overload who do not require hospital admission but require intravenous diuretic for relief of congestion.

Patients meeting the inclusion criteria, with prior informed consent, will be randomized to treatment with furosemide with hypertonic saline versus isolated furosemide (control group).

Complete clinical evaluation, echocardiography, and blood and urinary tests will be performed before the treatment. After 3 hours, diuresis volume, weight and urinary parameters will be evaluated. Efficacy and safety visits will be performed at 7 and 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Previous heart failure diagnosis (according to current European Guidelines)
* Stable treatment in the previous 4 weeks (except diuretic).
* Home oral treatment of ≥80 mg of furosemide/day or equivalent (40 mg furosemide = 20 mg of torasemide).
* Transthoracic echocardiogram performed in the last year.
* Congestive signs.The presence of two of the following congestion criteria will be required: jugular pressure\> 10 cm, lower limb edema, ascites, or pleural effusion
* Elevation of natriuretic peptides (NTproBNP\> 1000 pg / mL or B-type natriuretic peptide\> 250 pg / ml) performed in a previous period of no more than 24 hours.
* Need for intravenous diuretic therapy to relieve congestion according to the responsible physician.

Exclusion Criteria:

* Hospital admission criteria in the opinion of the responsible physician.
* Systolic blood pressure \<90 mmHg or\> 180 mmHg.
* Heart rate\> 150 bpm or \< 40 bpm
* Basal oxygen saturation less than 90%.
* Cardiogenic shock.
* Acute Pulmonary Edema.
* Clinically significant arrhythmia.
* Acute myocardial ischemia.
* Patients in hemodialysis or peritoneal dialysis program.
* Serum sodium \<125 milliequivalent / L or\> 145 milliequivalent / L.
* Serum potassium \< 3.5 milliequivalent/ L.
* Hemoglobin \< 9 g / dL
* Acute coronary syndrome or cardiological procedure in the previous 2 weeks.
* Severe uncorrected valve disease except tricuspid regurgitation.
* Moderate or severe dementia, active delirium or psychiatric problems.
* Patients in whom cardiac surgery or device implantation is planned in the following 30 days.
* Pregnancy or breastfeeding.
* Inability to give informed consent in the absence of a legal officer.
* Patients on tolvaptan.
* Inability to collect the urine.
Hypotension Prediction Index in Patients Undergoing Liver Transplantation

A prospective, open-label and single-center study to determine whether the use of Acumen Hypotension Prediction Index software predicts the occurrence of hypotension.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥ 20 years;
* Scheduled liver transplantation
* Planned pressure monitoring with an arterial line;
* General anesthesia

Exclusion Criteria:

* Contraindication for invasive blood pressure monitoring
* End-staged renal disease
* pre-operative MAP \<65 mmHg
* Severe heart failure
* Severe cardiac shunt
* Severe aortic stenosis
* Severe atrial fibrillation
Sevoflurane In Acute Myocardial Infarction

Ischemic postconditioning can reduce myocardial injury following myocardial infarction.

A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will reduce infarct size.

Patients with first STEMI that will be treated by primary PCI, will be randomized to sedation with Sevoflurane during the procedure or to usual care.

Eligibility Criteria:
Inclusion Criteria:

* First STEMI, presenting within 6 hours after the onset of chest pain
* Symptoms lasting \> 30 minutes
* Persistent ST-segment elevation \> 0.1 mV in 2 or more contiguous leads

Exclusion Criteria:

* Hypersensitivity to sevoflurane or other halogenated agents
* Malignant hyperthermia
* Cardiac arrest
* Cardiogenic shock
* Previous myocardial infarction or coronary bypass surgery
* Pre-infarction angina
* Heart failure (NYHA III/IV)
* Chronic inflammatory disease
* Severe renal impairment
* Hepatic dysfunction
* Use of Glyburide
East-West Collaborative Medicine Using Bee-Venom Acupuncture on Whiplash-Associated Disorders

1. Purpose of study

   1. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using VAS scale
   2. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using NDI, BDI, SF-36, and EQ-5D.
2. Interventions \& Groups

   1. group 1: Bee-Venom Acupuncture Therapy
   2. group 2: zaltoprofen
   3. group 3: Bee-Venom Acupuncture Therapy \& zaltoprofen


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Whiplash injuries
* Must have cervicalgia of more than VAS 5

Exclusion Criteria:

* cancer, osteoporosis, ankylosing spodylitis, cauda equina syndrome, infection
* spinal operation
* other musculoskeletal pain
* physicological or mental disorders
Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.

Consumers are increasingly encouraged to consume more plant-based foods and lower their consumption of foods from animal origin. However, the consequences of such a transition on muscle mass still remains to be explored. This is of particular importance in the older population, where sarcopenia is highly prevalent. The aim of this randomized controlled cross-over study is to investigate the short-term effect of a 10-day controlled vegan diet on daily muscle fractional synthesis rates in comparison to a 10-day controlled omnivorous diet in 35 community-dwelling older adults.

Participants will follow a fully controlled vegan diet, directly followed by a fully controlled omnivorous diet for 10 days, or vice versa. Researchers will compare the effect of the vegan diet to the effect of the omnivorous diet.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65-79 years old;
* Community-dwelling;
* BMI 20-35 kg/m\^2.

Exclusion Criteria:

* Following a vegetarian or vegan diet during the six months prior to the study;
* Following a diet that affects protein intake during the six months prior to the study;
* Participating in a structured exercise training program in the past three months;
* 5% or more body weight loss during three months before the start of the study;
* Being diagnosed with one of the following: diabetes; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer; chronic obstructive lung disease (COPD);
* Chronic use of medication that affects muscle function, e.g. corticosteroids, metformin, insulin;
* The use of the following medicines: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole.
* Allergic or intolerant to any product included in the diets;
* Not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin D;
* Not willing or afraid to give blood or undergo a muscle biopsy during the study;
* Unwilling to eat a vegan and an omnivorous diet for ten days each;
* Currently a research participant in another trial or participated in a clinical trial during three months before the start of the measurement period;
* Not being able to understand Dutch;
* Not having a general physician.
Changes in Thoracolumbar Fascia Stiffness and Pain Parameters in Young Patients With Chronic Low Back Pain

This study aims to investigate the biomechanical parameters of thoracolumbar fascia (TLF) and pain-related properties including pain intensity, pressure pain threshold (ppt) and pain sensitivity in young adults with non-specific chronic low back pain (LBP), both those experiencing chronic low back pain (LBP) and without LBP.

Non-specific low back pain has become a serious public health problem in latest years. The prevalence of low back pain is reported to be 84% in lifetime (1). Recently, an increasing number of studies have reported that fascia, due to its rich nociceptive innervations, may play a role in chronic pain, especially in some non-specific low back pain conditions .

This study will conducted with a total of 50 participant, including those with chronic lower back pain in the experimental group and the control group.

Both groups underwent assessments related to pain properties. Specifically, the Numerical Pain Scale(NMS) will be used to assess subjective pain intensity(4), the Digital Algometer for assessing pressure pain treshold(5), the Pain Sensitivity Scale(PSS) pain sensitivity(6) and the Myotonometer MyotonPRO biomechanical parameters, including stiffness(s), elasticity(d) and tonus (f) of the TFL at the level of Lumbal 1,3 vertebrae(L1,L3) and under 12th costa (7-10). SPSS 23.0 will be used for statistical analysis. p\<0.05 is considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* chronic back pain participants more than 3 months

Exclusion Criteria:

* Those with orthopaedic, neurological and systemic diseases will be excluded from the study.