cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon

There is substantial evidence that early childhood development (ECD) programming can improve child health and development outcomes. An important component of ECD programming is supporting positive parenting and early stimulation practices. While many parents could benefit from such programming, mothers that are HIV-infected may particularly benefit given the higher risks of poorer child development among HIV-exposed children. Catholic Relief Services (CRS) in Cameroon is implementing the Key Interventions to Develop Systems and Services (KIDSS) ECD program for HIV-exposed children. This impact evaluation will ascertain to what extent the KIDSS home-based component of the ECD model affects attainment of age-appropriate developmental milestones (measured by the Ages and Stages Questionnaire 3 (ASQ-3)) in HIV-exposed children in Cameroon. The study design is a cluster-randomized controlled trial with a cohort of 200 mother/child dyads across 10 study clinics. HIV+ mothers will be recruited during pregnancy and their children will be followed up until 18 months of age. The intervention group will receive regular home-based ECD services focused on positive parenting and early stimulation. The control group will not have any exposure to ECD services, though they may receive home-based services focused on HIV care and treatment, hygiene, and nutrition. Randomization occurs at the clinic (cluster) level.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* Pregnant and currently in 3rd trimester
* Must reside in Nkoldongo district or Djoungolo district
* Willing to be followed up for up to 21 months (pregnancy + postpartum periods)
* Agrees to voluntary participation
Autonomic Testing in Subclinical Carotid Atherosclerosis

Background: Atherosclerotic carotid intima-media thickness (IMT) may be associated with alterations in the sensitivity of carotid and subclavian baroreceptors.

Aim: The aim of this study is to investigate if carotid IMT is associated with changes in the autonomic modulation of the heart rate variability (HRV).

Methods: This is a prospective cross-sectional study. The carotid IMT is determined by B-mode and duplex ultrasonography. The cardiovagal function was determined through linear and nonlinear measures of HRV. Linear regression models, adjusted for demographics, comorbidities, body mass index, waist-hip-ratio, and left ventricular ejection fraction will be used to evaluate the association between HRV parameters and carotid IMT.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic patients aged 18 years and older without a history of transient ischemic attack, stroke, or other neurologic signs or symptoms are selected to participate in the study.

Exclusion Criteria:

* Patients with symptomatic carotid artery stenosis were excluded if the patient had transient or permanent focal neurologic symptoms related to the ipsilateral retina or the cerebral hemisphere.
* Patients with heart rhythm disorders, pacemaker, heart failure, ejection fraction less than 0.45, chronic renal failure on hemodialysis, severe liver failure, myocardial infarction, endarterectomy, carotid angioplasty, carotid dissection and carotid occlusion were excluded.
* Patients receiving drugs known to interfere with autonomic function, such as beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, vasodilators, statins, neuroleptics and nasal vasoconstrictors, were discontinued for 24 hours before the tests.
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis

Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.

Phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (PK) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the prevention of staphylococcal sepsis in VLBW infants (600 -1200 grams). Subjects monitored for treatment related adverse events and tolerability to infusion of study drug. Neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for S. aureus or two blood cultures positive for Coagulase Negative Staphylococci (CoNS). The study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

1. In-patient at a Neonatal Intensive Care Unit (NICU)
2. Informed consent obtained from the legally authorized representative
3. Less than 48 hours old at the time of first infusion
4. Birth weight between 600 grams and 1200 grams
5. Estimated gestation age ≤33 weeks

For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group.

Exclusion Criteria:

1. Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation.
2. Infants with proven staphylococcal infection prior to randomization.
3. Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
4. Immunodeficiency other than due to prematurity.
5. Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study.
6. Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study
7. Uncontrolled seizures
PRIORITI-MTF Study- Testing Patient Response to the IDEO

The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed brace, called the IDEO ™ along with a physical therapy program, called Return to Run, improves physical function. This brace was developed for wounded warriors who wanted to return to an active lifestyle.

The primary objective of this study is to examine the benefits (and cost-benefits) of an integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but designed for scalability in the broader military environment (i.e. beyond San Antonio Military Medical Center where the program was developed)


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-60
2. Currently two or more years out from a traumatic unilateral lower extremity injury at or below the knee
3. Healed fractures and able to fully weight bear
4. Evidence of either:

   * Weakness of ankle dorsiflexors and /or plantarflexors resulting from leg injury (defined as less than 4 out of 5 on manual muscle test)
   * Limited ankle dorsiflexion (\< 10 degrees) and /or limited ankle plantarflexion (\< 20 degrees) resulting from leg injury
   * Mechanical pain with loading to hindfoot/midfoot (\>= 50 mm on a 0-100 mm visual analogue scale assessing average daily pain)
   * Ankle or Hindfoot fusion or candidate for ankle or hindfoot fusion
   * Candidate for amputation secondary to ankle/foot impairment

Exclusion Criteria:

1. Ankle plantarflexion or dorsiflexion weakness as a result of spinal cord injury or central nervous system pathology.
2. Non-ambulatory
3. Surgery on study limb anticipated in next 6 months
4. Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia)
5. Neurologic, musculoskeletal or other conditions affecting contralateral extremity preventing the study of a healthy control limb
6. Unable or unwilling to participate in two 4-week PT programs
7. Pregnancy
8. Non-English speaking
Submerged vs. Nonsubmerged Single Laser-microgrooved Dental Implants.

Aim: to evaluate and compare radiographic marginal bone loss (MBL) and soft tissue parameters around submerged/two-stage and nonsubmerged/one-stage single implants with same tapered body design and surface, same thread design and distance, and same collar surface (laser-microgrooved), after 3 years of loading.

Materials and methods: 20 submerged/two-stage implants and 20 nonsubmerged/one stage implants were placed randomly with a split mouth design, in 20 partially edentulous patients. Radiographic and clinical examinations were carried out at the implant placement (Baseline, BSL), at the delivery of prosthetic restorations (T0), and at each year of the follow-up period (T1, T2, T3). Plaque index (PI), probing depth (PD), bleeding on probing (BOP), and gingival recession (REC) were recorded. Radiographic marginal bone levels (MBL) were assessed at the mesial (MI) and distal (DI) aspect of implant sites. In addition, the influence of keratinized tissue thickness (KTT) on MBL was investigated.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were: age ≥ 18 years, good general health, without contraindications to implant surgery, presence of at least two non-adjacent edentulous sites requiring implant therapy. Each implant site had to be located in the left or right hemi-posterior mandible or in the left or right hemi- posterior maxilla.

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Exclusion Criteria:

* Exclusion criteria were: implants placed into regenerated bone, lack of a periodontal chart and periapical radiograph at the beginning and at the end of follow-up period, alcohol and drug abuse, pregnancy, or uncontrolled metabolic disorders, tobacco smoking (\> 10 cigarettes/day), full mouth plaque score (FMPS), and full mouth bleeding score /FMBS) ≥25%, periodontally compromised patients (with attachment loss of 3 mm and/or radiographic bone loss of 30% of root length in 30% of sites), teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.
Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients

Labour is a very painful experience and epidural analgesia is considered the gold standard for pain relief in labour. Epidural scarcity, cost and shortage of skilled personnel to administer it is a limitation to it's usage in developing countries. Parenteral opioid analgesics such as pethidine and pentazocine are effective labour analgesia commonly used in developing countries but are limited by their side effects. This limitation in their use call for the need for alternative analgesic with similar or superior analgesic effect but with minimal side effects.The study is aimed at evaluating the efficacy and safety of combined tramadol and paracetamol in reducing labour pain among parturients.

There is paucity of data in our environment looking at the efficacy and safety of combined tramadol and paracetamol in relieving labour pain. This study will offer us great opportunity to evaluate their synergistic effect in labour when compared to the commonly used single opioids such as pethidine or pentazocine.

It would be a double blinded randomized controlled trial. One hundred and sixty-six pregnant eligible women in labour would participate in this study. Participants will be randomized equally into two study arms ( Tramadol plus Paracetamol study arm and Pentazocine study arm) after informed consent. The Tramadol plus Paracetamol study arm will receive 100mg of tramadol plus 600mg of paracetamol intramuscularly in a 2ml and 5ml syringe respectively while the pentazocine study arm will receive 30mg of Pentazocine and 2 milliliters of water for injection as placebo intramuscularly in a 2l and 5 ml syringes respectively. Both drugs will be administered to the participants at 4-6cm cervical dilatation during labour. The outcome measures will be evaluated within 5 hours in labour and an hour immediately after delivery. The need for additional rescue analgesia will be assessed as well. Fetal outcome on both arms will be noted too.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who presented in spontaneous labour at term, carrying Singleton Live Fetus in Active Phase of Labour with Cervical dilatation of 4-6cm who gave consent to participate in the study

Exclusion Criteria:

* Women with severe medical conditions such as diabetes mellitus, severe pre-eclampsia, cardiac, liver and renal disease
* Preterm Labour
* Intrauterine Fetal Death
* Fetal presentation other than cephalic
* Patients with previous caeserean section
* History of hypersensitivity to paracetamol, tramadol and pentazocine
* Complications such as antepartum haemarrhage, polyhydramnious, premature rupture of membrane
* Use of any kind of analgesia before recruitment
* Multiple gestation
* All other delivery except spontaneous vertex delivery Labour that was induced or augmented
Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

Pancreatic cancer is the 5th leading cause of death from cancer in France. When chemotherapy can be proposed, the choice of treatment is currently based on the patient's profile and expected tolerance. The endpoints currently used in trials, such as time to therapeutic failure, do not take into account the patient's experience of the disease. The use of quality of life questionnaires is often proposed, but frequent missing data and filling time can be a problem. In oncology, some studies have demonstrated, through questionnaires, the link between physical activity and quality of life. In this situation, ambulatory measurement of physical activity by wrist actimetry could be an integrative reflection of the impact of the disease and treatment (efficacy, tolerance) on patients. This type of evaluation, if accepted by patients, could usefully complement the measurement of quality of life in this population. No study has specifically looked at the use of devices of this type in the context of digestive cancer. The investigators propose to evaluate the acceptance of this type of device by pancreatic cancer patients receiving chemotherapy before evaluating its potential interest.


Eligibility Criteria:
Inclusion Criteria:

* Patient with unresectable pancreatic adenocarcinoma for whom an indication for chemotherapy has been decided upon after a multidisciplinary consultation meeting;
* Adult patient;
* Patients able to understand spoken and written French,
* Patient has given consent.

Exclusion Criteria:

* WHO ECOG stage III or IV ;
* Patient suffering from a major physical disability (hemiplegia, paraplegia, myopathy, amputation of a limb);
* Any alteration of comprehension capacities making self-evaluation impossible;
* Protected adult;
* Patient not affiliated to a national health insurance scheme;
* Pregnant or nursing women.
Precision Medicine for L/GCMN and Melanoma 2

The primary objective is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases. The secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients.

This is a unicentric national prospective observational study aimed at evaluating the use of two devices (skin patch and breath analyzer) for the non or minimally invasive diagnosis of metastatic melanoma with a total duration of 24 months. The study will be based on the obtention of different patterns of volatile organic compounds using the aforementioned devices for melanoma patients with and without metastasis. The results will be compared with the standard procedures for the detection of metastatic melanoma (standard imaging techniques such as PET, MRI, etc.) and correlated with standard prognostic biomarkers (cfDNA mutations in BRAF, NRAS, etc.) obtained using liquid biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old
* Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)

Exclusion Criteria:

* Not signing the informed consent form
* Present other cancers or chronic diseases (such as diabetes, asthma, etc.), which may affect the volatile organic compound profiles
Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery

A prospective randomized open-label study that will evaluate the effectiveness of the pliable and absorbable bone hemostats (BoneSeal®) on the reduction of bleeding from the sternal bone marrow in patients undergoing cardiothoracic surgery.

A prospective randomized open-label study that will evaluate the effectiveness of the pliable and absorbable bone hemostats (BoneSeal®) composed of synthetic materials and hydroxyapatite on the reduction of bleeding from the sternal bone marrow in patients undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair. This product will be compared to the similar, currently used product, Ostene®. Bleeding will be evaluated qualitatively by the surgeon as well as quantitatively by comparing pre- and post-operative hemoglobin levels, intra-operative and post-operative blood product usage, and post-operative chest tube output. A 30 day follow-up will be conducted to evaluate the patient's tolerance of the product, possible complications, or infection. Additionally, surgeons will be asked to comment on the ease of use of the product.

Eligibility Criteria:
Inclusion Criteria:

1. Consent given by patient prior to surgery
2. Adult patients over 45 years
3. Subjects requiring elective, prescheduled or urgent open heart surgery requiring a sternotomy including, but not limited to CABG, valve repair, valve replacement

Exclusion Criteria:

1. An immune system disorder
2. Known hypersensitivity to components in BoneSeal® or Ostene®
3. Patients undergoing emergency surgery
4. Patients undergoing aortic dissection
5. No consent given
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)

The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR Documented CCyR by bone marrow or BCR-ABL\<1% IS in the past 12 months Persistent disease demonstrated by two PCR positive tests 3 months apart both during the past 6 months.

Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose No other current or planned anti-leukemia therapies

Exclusion Criteria:

Patient has evidence of rising PCR (a confirmed \>1 log increase in previous 6 months) Patient has received another investigational agent within last 6 months or tyrosine kinase inhibitors (TKIs) other than imatinib Prior allogeneic stem cell transplantation

Impaired cardiac function including any one of the following:

Inability to monitor the QT interval on electrocardiogram (ECG) Long QT syndrome or a known family history of long QT syndrome. Clinically significant resting brachycardia (\<50 beats per minute) QTc \> 450 msec on baseline ECG (using the QTcF formula). If QTcF \>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc Myocardial infarction within 12 months prior to starting study Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension) History of or presence of clinically significant ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry
Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures

The purpose of this study is to gather information about a device used to help fix broken ribs.

Hypothesis: Rib fracture repair with the U-plate system is clinically durable and safe for the indications of flail chest repair, acute pain control, chest wall defect repair, and rib fracture non-union.

Rib fractures are a painful and disabling injury commonly found among trauma patients. According to the National Center for Health Statistics, approximately 300,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2004. Rib fracture patients are significantly more disabled at 30 days post-injury than patients with chronic medical illness and lose an average of 70 days of work or usual activity during their acute recovery.

The rationale for conducting this study is to demonstrate in a prospective study that the U-plate repair system is durable and safe. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that in order for the U-plate to be widely accepted, prospectively collected outcome data are necessary.

With the goal of improving the durability of fixation of rib fractures over the techniques currently available and with the additional goal of developing a minimally invasive technique, a U-shaped plate was developed. The design of the U-plate theoretically overcomes the inherent softness of the human rib by grasping the rib over its superior margin and by securing the plate with anterior to posterior locking screws that do not rely on screw purchase in bone. Thus much of the strength and durability of the fixation is transferred from the relatively soft rib to the plate itself.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age
* Subjects must have one of the four clinical indications listed below:

  1. Flail chest with failure to wean from ventilator (\> 5 days post-injury) and Paradoxical chest wall movement visualized; no significant pulmonary contusion and no significant brain injury
  2. Painful, displaced rib fractures (acute pain control) and failure of narcotics or epidural pain catheter to control pain; fracture movement exacerbates pain (after 7 - 10 days) and minimal associated injuries
  3. Chest wall defect/severely displaced fractures and non-repair defect may result in pulmonary hernia and severely displaced fractures are significantly impeding lung expansion in hemi-thorax
  4. Symptomatic rib fracture non-union and CT scan evidence of fracture non-union at least 2 months post-injury

Exclusion Criteria:

* Subjects who are enrolled in another investigational treatment trial
* Subjects who have received an investigational drug or device within 30 days of enrollment
* Subjects who are unable to complete the follow-up questionnaires
* Subjects with severe head injuries or other severe associated injuries
* Subjects who are not expected to survive the follow-up period
* Female subjects who are pregnant
* Non-English or English as Second Language speakers