cyrilzakka/clinical-trials huggingface dataset:
The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB)

3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing FDCs vs a single drug comparator in healthy volunteers

In this study the 4- and 2-drug FDCs (for intensive and continuation phases respectively) widely used within the South African treatment program will be evaluated in a comparative bioavailability study against a single drug rifampicin product registered by the South African Medicines Control Council. A three-way, single dose, cross-over study will be conducted in 24 healthy volunteers

Eligibility Criteria:
Inclusion

* You need to be between the ages of 18-55 years
* Have a Body mass index (BMI) of 19-30 kg/m2
* Weigh 45 kg or more
* Be a non-smoker
* Be found to be in normal health on history and examination
* To have normal blood and urine test results
* If you are a woman of child-bearing age, you need to be prepared to not have sexual intercourse, or use a safe form of contraception, until the end of the study

Exclusion

* You are unable to fully understand and comply with the study procedures, requirements and time commitments.
* Are currently enrolled in any other study evaluating drugs, biologics or devices
* You have TB, or have had TB before
* You abuse or have abused drugs or alcohol
* You have, or have had, drug allergy, severe asthma, or active or recurrent allergic disease
* You are pregnant
Empowering Girls: Health-seeking Behavior, Staying in School, and Preventing Risky Sex

This study will test the effectiveness of a phone-based big sister/big brother program designed to provide health information and support, reduce school dropouts, and promote safer relationships.

The program's goal is to create a phone-based safe space, to ensure adolescents remained connected with access to support and health information during COVID lockdowns.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent who provided their phone number to Young 1ove staff when prompted by their school; or their siblings/ other adolescents living in the same household.
* Parents and students consented to participate.

Exclusion Criteria:

-
Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 to 70 years of age
2. Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions
3. Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy
4. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1
5. Patients had to have recovered from any toxic effects of therapy
6. Patients with brain/meninges metastasis should keep stable disease for 2 months before randomisation
7. Adequate hematologic and biochemical values were required

Exclusion Criteria:

1. Presence of small-cell lung cancer alone or with NSCLC
2. Pregnant or breast-feeding women
3. Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure \> 140 mmHg，diastolic pressure \> 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency
4. Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction)
5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy
6. ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks
7. Bone fracture or wounds that was not cured for a long time
8. Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents
9. Mental diseases and psychotropic substances abuse
10. Previous treatment with an experimental agent within 4 weeks
11. Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS
12. Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)
Group B Strep Correlates of Protection Study

Streptococcus agalactiae or Group B Streptococcus (GBS) is a leading cause of neonatal sepsis in developed and developing countries.

The study aims to bolster the evidence base of establishing a sero-correlate of protection against invasive GBS disease in infants.

These sero-correlates of protection will be used to study the effectiveness of GBS vaccine against invasive disease.

Observational Case-Control Study

* A cohort of 15,000 mother-infant dyads will be enrolled at Chris Hani Baragwanath Academic Hospital (n=10,000) and Rahima Moosa Mother and Child Hospital(n=5,000) over an 18-24-month period, anticipated to start in the first quarter of 2019.
* Enrolment into the cohort study will occur at antenatal clinic, during the early stages either of labour or immediately post-delivery.
* In parallel, enrolment of GBS cases will occur at the time of diagnosis of invasive GBS disease. These "retrospective cases" will be enrolled at multiple facilities across South Africa.
* Infants will be followed up until 89 days of age to identify cases of suspected sepsis and hospitalizations.

Determine the infant GBS serotype Ia and III specific capsular serum IgG antibody level associated with 80% reduced odds of invasive GBS disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women attending for antenatal care at one of the participating antenatal-clinics and/or delivering at CHBAH or RMMCH.
2. Subjects aged ≥18 years.
3. Able to understand and comply with planned study procedures.
4. Provides written informed consent.

Exclusion Criteria:

1. Refusal to consent to study participation.
2. Receipt of any blood products in the past 4 weeks or anticipated during labour.
Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831

This research study is looking at tissue samples from women with breast cancer who were treated on clinical trial NCCTG-N9831. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PRIMARY OBJECTIVES:

I. To determine the association between the primary breast tumor protein expression of MYC, IGF-1R, and PTEN and disease-free survival (DFS) in patients randomized on clinical trial NCCTG-N9831.

II. To determine the association between the primary breast tumor amplification status of MYC and TOP2A and DFS in patients randomized on NCCTG-N9831.

III. To determine the association between the primary breast tumor mutation status of PIK3 and DFS in patients randomized on NCCTG-N9831.

SECONDARY OBJECTIVES:

I. To determine the association between the primary breast tumor marker protein expression/amplification/mutation status of the aforementioned markers and overall survival in patients randomized on NCCTG-N9831.

II. To investigate the predictive potential of multiple marker analyses on DFS and overall survival using multivariate analysis.

III. To determine the correlation between the protein expression and amplification status of MYC in patients randomized on NCCTG-N9831.

IV. To determine the correlation between marker protein expression/amplification/mutation status and known clinicopathological characteristics of the tumors.

Eligibility Criteria:
Inclusion Criteria

* Diagnosed with breast cancer and treated on clinical trial NCCTG-N9831

  \* Randomized to treatment
* HER-2 positive disease
* Whole tissue blocks and/or tissue microarray sections available
* Hormone receptor status:

  \* ER/PR status known
* Any menopausal status
Comparison Between Conventional vs. Endoscopic Lumbar Discectomy

This study is aimed to compare between the results of conventional lumbar discectomy and the newly used technique in our department; endoscopic lumbar discectomy in neurosurgery department Assiut university hospitals, so that we can offer our patients the best service in an updated and minimally invasive way.

Lumbar discectomy is one of the most common operation performed worldwide for lumbar-related symptoms. Lumbar disc herniation accounts for only 5% of all low back pain problems but is the most common cause of radiating nerve root pain, sciatica.

Mixter and Barr described the first surgical procedure to remove the herniated lumbar disc in 1934 through a laminectomy and durotomy, with later enhancement by Semmes, who described approaching the herniated disc through hemilaminectomy and retraction of the dural sac. This became popularized as the "classical discectomy technique.

During the latter half of the 19th century, more techniques were developed to remove the herniated disc with minimal invasiveness. The first herniated disc excision using a microscope (microdiscectomy) was performed by Yasargil in 1977, which was the standard surgical procedure at the time In 1993, Mayer and Brock and then in 1997, Smith and Foley described endoscopic discectomy techniques. With these minimally invasive techniques, authors demonstrated decreased soft tissue manipulation, operative time, blood loss, and hospital stay, allowing early recovery.

In this study we try to evaluate clinical and radiological outcomes of percutaneous endoscopic translaminar discectomy at our hospital.

Eligibility Criteria:
Inclusion Criteria:

* single level, postero-lateral, denovo lumbar disc herniation including those with migrated and/or sequestrated discs.
* L4,5 \&L5,S1 disc prolapse
* Failure of conservative management after 12 weeks.

Exclusion Criteria:

* central, far lateral, recurrent and/or multiple level disc herniation.
* Lateral recess stenosis or spondylolisthesis.
* presence of neurological deficit.
Intravenous VAL-1221 Lafora Expanded Access Protocol

Only qualified physicians treating a Lafora Disease patient may request VAL-1221 Expanded Access treatment under the Parasail Lafora Expanded Access Protocol (LEAP). According to FDA guidance, this protocol can enroll up to 10 patients. However, individual patient inclusion will ultimately be dependent on protocol eligibility, site geography, treatment requirements, and available supply of the investigational therapy. Inquiring physicians can submit a request by contacting the Central Contact personnel listed below in Contacts/Locations.


Eligibility Criteria:
Inclusion Criteria:

* Documented genetic diagnosis of Lafora Disease (LD) based on likely pathogenic or pathogenic variants in both alleles of either the EPM2A or the EPM2B gene
* Mid-stage in evolution of LD between 12 and 28 years of age
* Able and willing to comply with the protocol, including travel to Protocol Center, procedures, measurements and visits, including:

  * Adequately supportive psychosocial circumstances, in the opinion of the Investigator
  * Caregiver/trial partner committed to facilitate patient's involvement in the study who is reliable, competent, at least 18 years of age

Exclusion Criteria:

* Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the participant unsafe for inclusion or could interfere with the participant participating in or completing the protocol
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 80 years of age.
* Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
* Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
* Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

Exclusion Criteria:

* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study

(There are additional exclusion criteria)
Dynamic Gait Index in Hemiplegic Cerebral Palsy

The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI) in patients with unilateral spastic cerebral palsy

Cerebral Palsy (CP) is a childhood onset, lifelong neurological disorder, attributed to non-progressive injury of the fetal or immature brain. It causes movement deterioration and activity limitation. In CP patients increase in slow walking speed, shorter step length, and longer duration in the double support phase are common. Such gait changes are thought to reflect the unbalanced walking pattern seen in these children. Although children with CP are well known to have poor balance and high fall incidence, little effort has been made to quantify the dynamic walking stability of these children.

The Dynamic Gait Index (DGI) is a performance-based tool developed by Shumway-Cook and Woollacott to quantitatively measure dynamic balance capabilities. It also evaluates the individual's ability to modify gait in response to changing gait task requirements. Despite it's widespread use in the elderly population, DGI has not yet been investigated in children with neurological conditions. Considering that it takes a little time to apply the test, it may be advantageous for children in terms of simplicity and ease of administration.

In this study the investigators aim to validate and assess interrater and test - retest reliabilities of Turkish version of Dynamic Gait Index in children with unilateral, spastic cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of spastic unilateral cerebral palsy
* Age between 4 - 16
* Able to stand and walk without any orthosis or special equipment
* Volunteer to study

Exclusion Criteria:

* Being unable to walk
* Having cognitive disorder
* History of orthopedic surgery or any intervention for spasticity within the previous 12 months
* Uncontrolled epilepsy
* Visual conditions that prevent full participation to assessments
* Lower extremity contracture that may affect assessments
Adverse Events During Upper Gastrointestinal Endoscopy

The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population


Eligibility Criteria:
Inclusion Criteria:

* Patients will undergo upper gastrointestinal endoscopy
* Age \> 18 years old
* Signed informed consent form

Exclusion Criteria:

* Pregnant
* Allergy to propofol or soybean or albumen
Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

This is a randomized, multi-center, evaluator-blinded, no-treatment controlled study to evaluate the efficacy and safety of Restylane Perlane Lidocaine for correction of Midface Volume Deficit and/or Midface Contour Deficiency.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Men or women aged 18 years of age or older of Chinese origin
3. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
4. Subjects seeking augmentation therapy for the midface
5. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable HA gel/local anaesthetics, e.g.lidocaine or other amide-type anaesthetics.
2. Previous surgery or tattoo in the area to be treated
3. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.
4. Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim or neurotoxin within 12 months before treatment.
5. Scars or deformities, active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne psoriasis and herpes zoster near or in the area to be treated.
6. Other condition preventing the subject from entering the study in the Investigator's opinion.
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)

The investigators propose to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown, 2012).

Background: Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). There are limited evidence-based suicide prevention interventions that have been developed for military personnel and veterans who are experiencing suicide ideation or who have made a suicide attempt.

Objectives: To evaluate the efficacy of the Safety Planning for Military (SAFE MIL) on suicide ideation, suicide-related coping, and attitudes toward help seeking for hospitalized military personnel at high suicide risk.

Methodology: To test the efficacy of the adapted intervention, the investigators will randomize 186 patients to one of two conditions: Safety Planning for Military (SAFE MIL) or Enhanced Usual Care (E-CARE). The SAFE MIL condition (intervention) will consist of the Safety Planning Intervention to help the suicidal individual with a collaboratively generated personal plan to mitigate or prevent a future suicidal crisis. The E-Care will consist of the usual care patients receive at an inpatient facility during their hospitalization in addition to assessment services provided by independent evaluators who work directly with our research team. Primary outcomes include suicide ideation, suicide-related coping, and attitudes toward help-seeking \[acceptability and initiation of services\]. Patients in both conditions will be assessed on the dependent measures at the time of hospital admission (i.e., baseline), at the time discharge (Follow-Up Interval 1 \[FU-1\]), at 1-month (Follow-Up Interval 2 \[FU-2\]) and at 6-month (Follow-Up Interval 3 \[FU-3\]).

Eligibility Criteria:
Inclusion Criteria:

* Patient Admitted Due to Recent Suicide Intent and/or Suicide Attempt within past month
* Baseline Assessment Completed within 48 Hours of Hospital Admission
* Age of 18 years or older.

Exclusion Criteria:

* Medical Incapacity to Participate and/or Serious Cognitive Impairment
* Expected Discharge within 72 Hours of Admission
* Expected Deployment within 1-Month
* Inability to read or understand English
* Inability to provide Informed Consent
Prevalence of Osteoporosis in Sickle Cell Disease

Sickle cell disease is the most common single-gene disease in the world. Its prevalence is increasing in France, with patients' life expectancy increasing into developed countries. It mainly affects populations originating from sub-Saharan Africa. Among the chronic bone complications associated with sickle cell disease, osteoporosis has previously been highlighted but remains a poorly known complication in this very particular context. A dedicated evaluation of osteoporosis and associated risk factors in sickle cell disease patients living in France may enable better bone management of these patients in the future, as this problem, specific to their disease, is likely to become more frequent as their life expectancy increases.

This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteoporosis in black patients with sickle cell disease in France


Eligibility Criteria:
Inclusion Criteria:

* Black-skinned men and women
* Aged 20 to 40 years old
* Sickle cell patients
* Non-opposition to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
* Hemoglobinopathy other than sickle cell disease
* Severe or End Stage Renal Failure
* Long-term corticosteroid therapy (\>3 months)
* History of solid cancer or malignant haemopathy
* History of organ transplantation
* Pregnant or breastfeeding woman
* Psychiatric pathology seriously impeding understanding
* Difficulty understanding oral French
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.

IT001-310 is a Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. Approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. The primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on Day 12 (± 1 day)/Test of Cure (TOC).

Eligibility Criteria:
Inclusion Criteria:

* Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI
* Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
* A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine

Exclusion Criteria:

* Presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature \> 38° Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
* Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
* Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.
* Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis
* Ongoing urinary retention
* Neurogenic bladder
* Current resident of a long-term care facility
* Instrumentation of urinary tract in the previous 30 days
* An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract
* Any history of trauma to the pelvis or urinary tract
* Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant
* History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients