cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety and Performance of CMF Porous Titanium Implants

The goal of this retrospective study is to evaluate the clinical characteristics, efficiency, safety, and long-term performance of craniomaxillofacial (CMF) Porous Titanium Implants within the standard of care across children (0 - \<12 years old), adolescent (12 - \<22 years old), and adult (≥ 22 years old) populations.

The loss of bone substance or continuity in the cranial and/or facial region can result from trauma, infection, benign or malign tumor resection, and therapeutic side effects (e.g., radiotherapy). CMF Porous Titanium Implants are patient-specific solutions matched with the patient's anatomy to reconstruct bone defects accurately. Following a premarket clinical evaluation and considering long-term risk management, the decision to conduct a retrospective post-market clinical follow-up study was based on identifying possible residual risks and uncertainty about long-term safety and clinical performance that may impact the benefit/risk ratio of the CMF porous titanium devices, thereby ensuring the continued safety and efficacy of these CMF devices.

Eligibility Criteria:
Inclusion Criteria:

* Age: Patients of any age are eligible for this study.
* Patients treated with Materialise patient-specific CMF Porous Titanium Implants for facial and/or cranial reconstruction.
* Patients who have followed Standard of Care, as determined in each case by the treating surgeon.

Exclusion Criteria:

* Known hypersensitivity to Titanium at the time of surgery.
* Patients who had or will receive the TMJ Total Arthroplasty System.
* Pregnancy at the time of surgery.
Lubiprostone for Children With Constipation

This study is for children with constipation.

Children who completed 3 months of treatment in the earlier study (NCT02042183):

* were invited to participate
* will receive lubiprostone for 9 more months
* will see if lubiprostone safely relieves their constipation if taken for a whole year


Eligibility Criteria:
Inclusion Criteria:

* Has completed the 3-month placebo-controlled study (NCT02042183)
* Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility

Exclusion Criteria:

* Has untreated faecal impaction at the time of rolling over into study
* Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease
* Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)
Prospective Observational Study of Difficult Intravenous Access in the Operating Room

This is an observational study only, where number of attempts to establish peripheral IV catheter placement will be recorded during procedures in all anesthetizing location on the main campus of Nationwide Children's Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients 0-18 years of age
* Having surgery at Nationwide Children's Hospital

Exclusion Criteria:

* Pre-existing IV upon arrival to the operating room
Tecovirimat for Treatment of Monkeypox Virus - Study Extension Providing Standard of Care Only

The purpose of the PALM007 extension is to further characterize the clinical and natural history of mpox, and to provide standard of care (SOC) during the ongoing outbreaks.

This open-label extension to the PALM007 protocol began in July 2024 after enrollment into the main study ended. It will further clinically characterize the natural history of mpox, and continue to identify recrudescent cases. Participants were initially provided SOC as well as open-access tecovirimat. The results of PALM007 were unblinded in August 2024, and although no safety concerns were observed with tecovirimat use, efficacy, defined by improvement in days to complete mpox skin lesion resolution, was not observed for tecovirimat compared to placebo. Therefore, the administration of tecovirimat in the extension amendment was discontinued in early August 2024, once these results were known, and only SOC continues to be provided.

Participants are admitted to the hospital and receive SOC for mpox until they have recovered. Recovery is defined as resolution of all lesions and a negative blood test for MPXV. Participants will remain on study through day 59 but will not have a scheduled study visit unless they present with new mpox symptoms. Sick visits will be available for participants who reach full body lesion resolution but subsequently develop at least 1 new lesion consistent with mpox after discharge and on or before day 59, at which time viral PCR and clinical laboratory testing will be performed and participants will be offered standard of care.

Eligibility Criteria:
This study has no age restriction

Inclusion Criteria:

* Laboratory-confirmed mpox infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
* Mpox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
* Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study
* Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so
* Individuals previously enrolled in PALM007 will be included.

Exclusion Criteria:

* Severe anemia, defined as hemoglobin \<7 g/dL
* Current or planned use of another investigational drug at any point during study participation
* Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
Incidence and Associated Factors of Persistent Postoperative Incision Scar Pain Following C/s in Mulago Hospital

prospective cohort study of women who underwent caesarean section in mulago hospital. followed up for 2 months and assessed for development of persistent post operative pain at the incision site and its effect on quality of life. incidence of persistent postoperative pain and associated factors determined.

prospective cohort study of 277 women who underwent caesarean section in mulago hospital. demographic, medical history, intraoperative, postoperative details, and perioperative levels of pain collected. followed up by telephone interviews for 2 months and assessed for development of persistent post operative pain at the incision site and its effect on quality of life. incidence of persistent postoperative pain and associated factors determined.

Eligibility Criteria:
Inclusion Criteria:

- ASA I, II, and III.

* patient who has given informed consent.

Exclusion Criteria:

* patients who have no telephone contact
Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis

Amputation of a limb may result from trauma or surgical intervention. The amputation traumatically alters the body image, but often leaves sensations that refer to the missing body part. In 50-80% amputees, neuropathic pain develops, also called phantom limb pain (PLP). Both peripheral and central nervous system factors have been implicated as determinants of PLP. Also, PLP may be triggered by physical (changes in the weather) and psychological factors (emotional stress). Recent evidence suggests that PLP may be intricately related to neuroplastic changes in the cortex, and that these changes may modulated by providing sensory input to the stump or amputation zone.

A non-invasive clinical trial will test the effectiveness of non-invasive pressure sensory feedback build into a hand prosthesis to alleviate phantom limb pain.

During the pre-screen phase the investigators will assess whether the patient experiences referred phantom limb sensations or pain. In the case that the patient does experience referred sensations on the stump the investigators will map the areas where the sensation occurs on the stump and utilize this for placement of the surface actuators. In the opposite case, actuators will instead be placed in a matrix structure at the residual limb.

As a first step towards applying mechanical stimulation, the sensation thresholds (the level of stimulation where the subject first reports a sensation) have to be determined. The outcome of this procedure is a minimum of stimulation amplitude that can be applied for each stimulation site.

A first choice would be to use the referred map to place actuators. However, amputees have different phantom maps and also the number of areas varies.

A therapy will be defined based on the use of sensory feedback system integrated with the amputees hand prosthesis. The subject should use the hand prosthesis, with sensory feedback, for a duration of minimum 2 h per day during a 4 week period.

Preferably, the system should be used actively in normal daily activities.

Eligibility Criteria:
Inclusion Criteria:

* Transradial amputation
* Amputation should be in a stable phase
* Other treatments for PLP tried with poor result
* PLP experienced as over 6 on a visual analogue scale

Exclusion Criteria:

* Cognitive impairment
* Pregnancy
* History of active substance abuse disorder
* Acquired brain injury with residual impairment
* Intelligence disability
* Neurologic or musculoskeletal disease or other diseases that may affect the function of nervous system
* Pacemaker
* dermatologic condition
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients aged 5 to 17 years.
* Written consent / assent.
* Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
* Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
* Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.

Exclusion Criteria:

* Patients who have received any desensitisation treatment for grass pollen.
Clinical and Radiological Outcomes Following Insertion of a Novel Removable Percutaneous Interspinous Process Spacer: an Initial Experience.

Purpose To evaluate clinical and radiologic outcome of a series of patients treated with a removable percutaneous interspinous process spacer (IPS) (LobsterProject® Techlamed®) for symptomatic degenerative lumbar spinal stenosis (DLSS).

Methods All patients treated in the two considered Centres with this IPS during 2019 were retrospectively reviewed. Patients with incomplete clinical or radiological documentation were not included. Procedures were performed under deep sedation or general anaesthesia by two interventional radiologists. Patients were clinically evaluated before intervention and at 3-month follow-up with Visual Analog Scale for pain (VAS), Oswestry Disability Index (ODI) and radiologically with MRI or CT scans. Neural foramina were independently measured for each patient on pre- and post-procedural CT scans by two radiologists.


Eligibility Criteria:
Inclusion Criteria:

* removable percutaneous IPS treatment
* attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment

Exclusion Criteria:

* PS positioning included cauda equina syndrome
* permanent motor deficit,
* previous spine surgery,
* spondylolisthesis greater than Meyerding grade I,
* local or systemic infection and severe osteoarthritis with pronounced osteophytosis or bone bridges
Water-based Versus Land-based Exercise for Breast Cancer Survivors

Physical activity and exercise have demonstrated to be an integral part of the cancer-continuum care. Despite strong evidence suggesting that both endurance and strength training should be encourage in cancer patients, there is still controversy regarding exercise dosage, frequency, volume and optimal environment of delivery. In this randomised controlled trial we aim to compare water-based versus land-based exercise in breast cancer survivors to decrease cancer-related fatigue (CRF), improve Health-Related Quality of Life (HRQoL), exercise tolerance, muscle strength and physical activity levels.


Eligibility Criteria:
Inclusion Criteria:

* Breast Cancer patients post cancer treatment (at least for 6 months)
* Cancer-free at the time of recruitment
* Signed informed consent
* Living in the metropolitan area of Barcelona

Exclusion Criteria:

* Fear of water
* Receiving cancer therapy at the time of recruitment
* Not willing to participate/Refuse to sign informed consent
* Physical of cognitive impairments precluding the patient to perform the exercises
Study of Venous Endothelial Cells in Rheumatoid Arthritis

Heart disease is the major contributor of early death in rheumatoid arthritis (RA) and is not influenced by traditional risk factors. Blood vessel dysfunction has been associated with heart disease and complications such as heart attack. The vessel dysfunction is thought to be mediated in part to inflammation. RA patients have evidence of vessel dysfunction seen on ultrasound that improves after medications are given.

The purpose of this study is to evaluate patients with controlled or uncontrolled rheumatoid arthritis to determine if there is a difference in the protein expression in the cells that line the blood vessels compared to healthy people.

The study will consist of a cross sectional analysis of venous endothelial cells in rheumatoid arthritis patients who have controlled or uncontrolled disease and healthy controls. We will collect venous endothelial cells by placing an IV in antegrade position in the forearm and a thin wire will be inserted to collect the cells from the inner lining of the vein. The cells will processed and stained for markers of endothelial function and oxidative stress including endothelial nitric oxide synthase (eNOS), phospho-eNOS, nuclear factor kappa B (NFκB), and nitrotyrosine using immunofluorescence technique. Flow mediated dilation (FMD) by ultrasound of the brachial artery on the contralateral arm will be used as an additional marker of endothelial function. A blood sample will be taken for analysis of inflammatory markers (sedimentation rate, C-reactive protein) and cytokine analysis (IL-1, IL-6, TNFa) by cytokine bead array and flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

Rheumatoid arthritis:

* Age 18-75 years
* Rheumatoid arthritis defined by 1987 American College of Rheumatology criteria
* Attending clinic at University of Texas Southwestern Aston Clinic for Rheumatology or Parkland Arthritis Clinic.

Healthy controls:

- Age 18-75 years.

Exclusion Criteria:

Rheumatoid arthritis:

* Insulin dependent diabetes
* Cardiovascular or Cerebrovascular disease
* Tobacco use in last 24 months
* Uncontrolled blood pressure
* Uncontrolled cholesterol
* Pregnant or nursing
* Prednisone greater than 10mg per day
* Stable methotrexate dose for less than 4 weeks
* Undergoing Infliximab infusions

Healthy controls:

* Insulin dependent diabetes
* Cardiovascular or Cerebrovascular disease
* Tobacco use in last 24 months
* Uncontrolled high blood pressure
* Uncontrolled cholesterol
* Pregnant or nursing
Iron Supplementation Among Low-Income Postpartum Women

Anemia is common among low-income women after they have given birth. Anemia, or low hemoglobin in the blood cells, is usually caused by not having enough iron. Blood cells usually carry oxygen to other parts of the body. Without enough hemoglobin, the ability of blood cells to carry oxygen is decreased. Memory and work may be impaired. The purpose of this study is to evaluate three methods of giving iron to prevent anemia among low-income women after they have given birth.

Currently the Centers for Disease Control and Prevention recommendations to prevent iron deficiency advocate selective screening and treatment of anemia at about 6 weeks postpartum. However, among some groups, such as low income women, data suggest that anemia and iron deficiency are common. This study aims to evaluate the effectiveness of three stategies to prevent iron deficiency among low income postpartum women in Mississippi.

Comparisons: Clinics will be randomized to one of three strategies: 1)Selective anemia screening and treatment of anemic women, 2)universal anemia screening and treatment of anemic women, or 3)universal iron supplementation of 65 mg a day for three months.

Eligibility Criteria:
Inclusion Criteria:

* postpartum girls and women, 2-6 weeks after birth
* age 13 years or more
* WIC certified

Exclusion Criteria:

* sickle cell anemia
* Hemoglobin \< 7 g/dL
Study Examining Parker-Flex Endotracheal Tube for Obese Patients

A recent article examined the use of Parker Flex-Tip tubes to standard ETTs for oral fiberoptic intubation and concluded that there was a significant benefit in terms of difficulty encountered when using the Parker Flex-Tip. The Parker Flex-Tip tracheal tube has a flexible, curved, and tapered tip design different from traditional endotracheal tubes. The design allows the tube to lie closely against the fiberoptic scope that is often used to facilitate intubation, resulting in a smaller gap between the ETT and the fiberoptic scope. This may allow the ETT to clear anatomic obstructions more easily. The patients they examined had an average body mass index (BMI) categorized as normal weight. To our knowledge, there have not been any studies that have investigated the use of the Parker Flex-Tube for fiberoptic intubations in patients categorized as obese by BMI. Our hypothesis is that the Parker Flex-Tip ETT results in easier passage of the ETT over a fiberoptic scope during elective fiberoptic intubation of obese patients in comparison to a traditional ETT.

This is a randomized, double-blinded study. Neither the patient nor the anesthesia practitioner advancing the ETT will know the group to which the patient has been assigned. On the day of surgery, participants will be randomized 1:1 to one of two groups. Both groups will be electively intubated with a fiberoptic scope. One group will be intubated using a Parker-Flex endotracheal tube and the second group of will be intubated with a standard endotracheal tube. There will be an equal probability of being assigned to either group. No placebo or control group will be used. Randomization will be computer-generated and assignments will be enclosed in sealed envelopes to provide allocation concealment. The anesthesiology technician involved in the case will open the envelope at the start of the case and will not be blinded to the study, due to the fact that the technician must prepare the endotracheal tube for the fiberoptic intubation.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 30 or greater
* American Society of Anesthesiologists (ASA) Physical Status Classification I- III
* Patients scheduled for elective procedures requiring general anesthesia and endotracheal intubation.

Exclusion Criteria:

* Predicted difficult airway based on physical exam and patient's history
* Rapid sequence intubation indicated (patients who require to be intubated as quickly as possible)
* Prior trauma or surgery in the oropharynx/larynx
* Known abnormal laryngeal structures (tumors)
* Infectious and toxic conditions
* Cervical spine instability
* Emergency surgery
Prevalence of Tongue Anomalies in Egyptian Children

The purpose of the study is to determine the prevalence of tongue anomalies in a group of Egyptian children and to relate the presence of malocclusion in cases of macroglossia, tongue tie and microglossia.

The tongue is an important and accessible muscle in the oral cavity, it has many functions which includes speech, chewing, swallowing, sucking, control of breathing, growth and developments of the jaws and perception to pain.

Also, many systemic disorders and diseases affect the tongue which makes it a great reflector of the general health.

Tongue anomalies has different frequencies and prevalence between different countries, these differences may be due to geographic, ethnic, gender and age variability, for example a study in Iran in 2003 found that the prevalence of tongue anomalies 34.3%, while another study in Colombia in 2013 found that the prevalence of tongue anomalies on their study population was 79.9%.

The knowledge of the prevalence of tongue anomalies among Egyptian children is missing in the literature which could compromise the quality of dental care, increase the occurrence of orthodontic problems and decrease the chances of early detection of some systemic diseases, since tongue anomalies could help in early determination of some systemic diseases in cases of fissured tongue and geographic tongue as well as early prevention and early intervention of malocclusions and speech defects that might be caused in cases of microglossia, macroglossia and ankyloglossia.

Hence, the knowledge of prevalence of tongue anomalies among Egyptian children can aid in setting a reference which will then help in public health planning and prevention policies.

Eligibility Criteria:
Inclusion Criteria:

* Participants' age between 6-12 years.
* Co-operative child
* Positive participants' acceptance for participation in the study.
* Participants having responsible care giver answered by approval on the previously sent informed consent which describes the aim \& importance of the study

Exclusion Criteria:

* Patients with history of significant medical conditions
* Participants undertaken anti-fungal drugs in the previous 12 months
Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis

The purpose of the study is to evaluate the effect of homeopathy as an adjuvant to Anti tuberculosis treatment on sputum conversion, hematological, clinical sign and symptoms of relapsed Pulmonary TB.


Eligibility Criteria:
Inclusion Criteria:

relapse pulmonary tuberculosis patients with acid-fast bacilli smear positive by microscopy, using ZiehlNieelsen staining as recommended by WHO, unfit for DOTS -

Exclusion Criteria:

pregnancy, clinical sign of any concomitant disease such as diabetes mellitus, acute renal failure or infectious disease including TB/HIV and HIV positive, currently or taken any alternative therapies in past 6 months
Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation

This pilot study proposes to perform measurements of approved thoracic impedance technology that will help answer questions in patients with decompensated heart failure.

Improved metrics derived from the transthoracic impedance (Z) available from implanted Medtronic devices may provide more sensitive indicators of the state of compensation for heart failure patients. Quantification of specific data may provide new information that can improve quality of life for patients and offer vital information to clinicians regarding the adequacy of inpatient and outpatient assessment and management of acute decompensated heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with systolic dysfunction
* Able to provide informed consent
* Have a Medtronic manufactured device with Thoracic Impendence Monitoring capabilities

Exclusion Criteria:

* Patients with severe congestive heart failure who are intubated
* Patients who are oxygen dependent on continuous positive or bilevel positive ventilation
* Inability to tolerate postural variations due to congestive heart failure or other medical or surgical condition.Unable to complete proposed testing
* Subjects who cannot giveWill not give written, informed consent on their own behalf