cyrilzakka/clinical-trials huggingface dataset:
Effects of Task-Oriented Intervention in Children With Developmental Coordination Disorder

physical coordination is impacted by developmental coordination disorder (DCD), commonly referred to as dyspraxia. It makes a youngster appear to move clumsily and perform worse than expected in everyday tasks for their age. Fine and gross motor coordination issues are a hallmark of this neurodevelopmental disorder. Task-oriented therapies help children with DCD develop their skills, coordination, and manipulative abilities by including them in intentional, goal-directed tasks. This is noteworthy because a child's quality of life can be greatly impacted by these skills, which are essential for everyday tasks like writing, tying shoelaces, walking, and balance. The purpose of the research is to ascertain how task-oriented upper limb intervention affects children with impaired coordination and hand-eye coordination.

The task-oriented intervention aimed at the upper limbs will be administered to the intervention group. For 3 months, interventions were offered 3 days a week.Over the course of 6 months, this quasi-experimental study will be carried out in Lahore. Data will be gathered from the Harbanspura branch of The Punjab School and the Askari School System in Mughalpura. There will be 18 students in the study. The study's inclusion criteria will be children with developmental coordination disorders between the ages of 4 and 12 Youngsters needed to be able to comprehend and adhere to instructions, both boys and girls who scored between 15 and 57 overall on the Developmental Coordination Disorder Questionnaire 2007.Children with congenital respiratory, cardiovascular, or musculoskeletal disorders, as well as those with unstable seizures, will be excluded. Both before and after the operation, data will be gathered. The Movement Assessment Battery for Children (MABC-2), the Developmental Coordination Disorder Questionnaire, and the ABIL HAND KID instrument will be used to assess subjects with developmental coordination disorders.

Eligibility Criteria:
Inclusion Criteria:

* Developmental coordination disorder children aged 4 to 12 years old.
* Have a total score of 15-57 on the Developmental Coordination Disorder Questionnaire2007.
* Children had to be able to understand and follow instructions.
* Boys and girls both are included

Exclusion Criteria:

* Children with unstable seizures will be excluded.
* DCD children with any congenital cardio-respiratory condition, congenital musculoskeletal condition.
* DCD children with severe visual and/or hearing disability preventing them from completing exercises prescribed by either program.
* Children with behavioral difficulty making them unable to complete exercises prescribed by either program
Effect of Magnesium on Remifentanil Induced Cough

The hypothesis of this study is that Magnesium sulfate pretreatment (50mg/kg) will reduce the incidence of cough and chest wall rigidity caused by remifentanil administration.

The purpose of this study was to investigate the effect of magnesium sulfate administered before induction of anesthesia on thoracic stiffness and cough response caused by opioid analgesics administered for general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-75 years of age who are undergoing surgery under general anesthesia using a laryngeal mask and who have consented to participate in this study among American Society of Anesthesiologists body grade 1 or 2

Exclusion Criteria:

* When coughing may occur due to an underlying disease (upper respiratory infection, rhinitis, post nasal drip, asthma, chronic obstructive pulmonary disease, pneumonia, bronchitis, current smokers, etc.)
* If you have kidney disease that can affect magnesium metabolism (glomerular filtration rate less than 60)
* If you are taking opioid analgesics or magnesium for other reasons
* Patients with hypermagnesemia
* Patients with atrioventricular block (stages I-III) or other cardiac conduction disorders
* Pregnant or lactating women
* Patients with myasthenia gravis
* Patients taking drugs that are contraindicated or interact with magnesium (barbitalates, aminoglycoside antibiotics, isoniazid, chlorpromazine, digoxin)
* In case of hypersensitivity to magnesium
* Patients with a history of hypersensitivity to propofol and any of its components
* Patients with a history of hypersensitivity to remifentanil and other fentanyl analogues
Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1) Patients must have one or more of the following:

1. confirmed diagnosis of active SARS-CoV-2 infection, diagnosed with PCR
2. continued close contact with an individual with suspected SARS-CoV-2 infection
3. at risk for SARS-CoV-2 infection in the opinion of the treating physician or Principal Investigator.

Exclusion Criteria:

1) Patients must not have any uncontrolled disease such as:

1. cardiovascular disease
2. hepatic disease
3. renal disease
4. metabolic disease
5. other diseases or insufficiencies
Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19

The primary objectives are:

* To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo
* To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration

The secondary objectives are:

* To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo
* To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration
* To assess the immunogenicity of REGN10933 and REGN10987


Eligibility Criteria:
Key Inclusion Criteria:

1. Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study
2. Stable medication for co-morbid condition(s) for at least 6 months prior to screening
3. Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission

Key Exclusion Criteria:

1. Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization
2. Subject-reported clinical history of COVID-19 as determined by investigator
3. Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection
4. Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19
5. Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening
6. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations) in the past 6 months prior to screening
7. Received investigational or approved SARS-CoV-2 vaccine
8. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol
9. Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening

NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents

The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.

This is an uncontrolled, prospective, multicentre post-market clinical follow-up investigation that will enroll male and female children /adolescents with a need for low-volume transanal irrigation (TAI) as judged by the investigator or designee.

A total of 27 subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use. Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four (4) to six (6) weeks.

The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm device safety when used in children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male and female children/adolescents between 3 and 17 years of age at the time of inclusion
* Diagnosis of at least one of the following:

  * functional constipation not well treated with oral laxatives
  * functional fecal incontinence, either retentive or non-retentive (FNRFI: Functional Non-Retentive Fecal Incontinence) not well treated with oral laxatives
  * neurogenic bowel dysfunction due to spinal abnormalities and/or spinal cord injury or cerebral palsy
  * patient with sequelae of anorectal malformations to Hirschsprung disease
  * Fecal Incontinence (FI) due to iatrogenic injury including tumor surgery sequelae
* Symptom duration of \> 3 months
* Subject and/or their legally designated representative can communicate in written and oral Swedish language

Exclusion Criteria:

* Children/adolescents previously treated with, or currently in need of, high volume TAI, i.e., volume \> 250 ml
* Confirmed pregnancy at the time of enrollment
* Participating in another clinical investigation interfering with this investigation
* Subjects with an active, symptomatic, inflammatory bowel disease, radiation proctitis, and or active perianal fistula disease
* Rectal bleeding of uncertain origin or active hemorrhoidal bleeding
* \< 6 months after anal or colorectal surgery
* Ongoing anti-coagulant therapy (i.e., NOACS, heparin, warfarin)
* Ischemic colitis
* Active anal fissure
* Inability to use the product or anyone to assist in its usage (hand function assessment)
* Person not suitable for the investigation according to the investigator's judgment
OssDsign® Spine Registry Study ("Propel")

The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.

This multi-center study (up to 10 US study sites) is a post market, prospective, observational spine fusion registry. The outcomes of patients undergoing spine fusion with OssDsign® bone grafts will be documented and evaluated for the purposes of post market clinical follow up as part of OssDsign® post market surveillance activities. The length of study duration and number to be recruited is open-ended but initially a target of 300 subjects will be recruited and followed up for a period of 24 months ± 90 days after their index surgery in which an OssDsign® bone graft has been implanted.

Eligibility Criteria:
* The patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an OssDsign® bone graft is appropriate.
* The patient is ≥21 years old.
* The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
* The patient is willing and able to participate in post- operative clinical and radiographic follow up evaluations for 2 years.

Exclusion Criteria:

* Patients not meeting all of the inclusion criteria
Morphological Pattern of the Atrophic Posterior Maxillae

Overcoming the vertical and horizontal bone deficiency in the posterior maxillae are considered as the most challenging scenarios for implant-supported oral rehabilitation in modern implant dentistry. Therefore, a comprehensive and precise understanding of such anatomical structures are needed to avoid potential complications that ultimately might jeopardize the treatment outcome.

Cone-beam computerized tomography (CBCT) offers some advantages to conventional CT-scan such as lower-dose radiation with high isotropic spatial resolution and cost. Therefore, it offers a viable and reliable tool to study anatomical structures such as the posterior atrophic maxillae


Eligibility Criteria:
* Images were included if:

  1. Pristine maxillary posterior atrophic ridges (between premolars and molars) as a result of missing single or multiple teeth for over than 12 months.
  2. Residual ridge height (RH) was \< 10 mm.
  3. Presence of teeth adjacent to or opposing the edentulous area so the location of the edentulous ridges corresponding to the tooth site could be identified.
  4. The maxillary sinus to be measured was visible from its floor to at least 15 mm from the alveolar crest of the edentulous ridge.
* Images were excluded if:

  1. Images were unclear or incomplete due to scattering or other reasons
  2. Edentulous ridge height was more than 10 mm
  3. Ridge preservation/augmentation simultaneous/delayed to tooth extractions
  4. Grafted maxillary sinus for implant-supported prosthesis
  5. The location of the edentulous ridge cannot be determined
  6. Implants or other prosthetic device restoring the posterior ridge
  7. Presence of sinus pathology that made the measurement impossible
  8. The outline of the edentulous ridge cannot be identified due to low 'grey scale' density
Transversus Abdominis Muscle Release Versus Mesh Only Repair in the Treatment of Complex Ventral Wall Hernia

This trial was designed as a prospective randomized, controlled, intervention, with two parallel groups, and a primary endpoint of recurrence during 12 months' follow-up after initial treatment, with the randomization, was performed by an online software a 1:1 allocation.

Eligibility Criteria

* both sexes
* aged between 18 and 65 years old
* presented complex ventral wall hernia or incisional hernia

Exclusion

* pregnant
* patients on steroid therapy
* underwent their hernia repair on an emergency basis

Interventions

* Eligible patients were randomized in equal proportions between "Mesh Only Repair" and "Posterior Component Separation with Transversus Abdominis Muscle Release"

Eligibility Criteria:
Inclusion Criteria:

* patients with complex ventral-wall and incisional hernia

Exclusion Criteria:

* pregnant female
* steroid therapy
* emergency basis
Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.

Osteoarthritis (OA) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of OA.

A survey of 2000 French general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee OA. With the increasing importance of non-pharmacological treatment in recommendations for OA, orthoses will increase in use.

The use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. It can even delay the need for surgery.

The aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Medial femorotibial knee osteoarthritis grade 2, 3 or 4 according to the Kellgren Lawrence system
* Visual Analog Scale pain ≥ 40/100 in the last 48 hours
* Signed informed consent prior to any study-mandated procedure.
* Affiliated to the General regime of the Social Security or covered by a similar health insurance system

Exclusion Criteria:

* Inability to walk or dependance on a wheelchair or use of crutches.
* Diseases that do not allow participation in the study for a period of six weeks.
* Concomitant ipsilateral patellofemoral osteoarthritis associated with a more severe pain than the one for medial OA.
* Ipsilateral osteoarthritis of the hip associated with a more severe pain than the one for medial OA.
* A body mass index over 35.
* Successful Cortisone injection within the last four weeks before the start of the study.
* Participation to any other clinical study which has an impact on the different endpoints.
* Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
* Inability to communicate in German.
LCI in Chronic Atrophic Gastritis and Early Gastric Cancer

Color change is a useful marker for the endoscopic identification of chronic atrophic gastritis (CAG) and gastric cancer (GC). Several histopathological studies have suggested a correlation between certain gastrointestinal lesions and intramucosal vascularity. The aim of this study is to investigate the association between the color and mucosal microvascular density of CAG and early GC using linked color imaging (LCI). In this study, Lesions diagnosed as CAG and early GC will be observed using LCI. In each image, the color values of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

In this study, 10 patients diagnosed with CAG or early GC by esophagogastroduodenoscopy at Fifth Medical Center of Chinese PLA General Hospital between September 2023 and December 2023 will be enrolled. The following equipment will be used for the study: LCI endoscope (EG-760Z, FUJIFILM Co., Tokyo, Japan), light sources (LASEREO LL-4450; Fujifilm Co.), and video processors (AdvanciaHD VP-4450HD; FUJIFILM Co.). During esophagogastroduodenography, the atrophic or cancerous border will be identified. Following identical compositions, images will be continuously captured via LCI. Endoscopic biopsy or resection will be performed, and the mucosal microvascular density will be histopathologically analyzed using the specimens. The color values of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic atrophic gastritis (CAG) and early gastric cancer (EGC). by esophagogastroduodenoscopy

Exclusion Criteria:

* Inappropriate LCI images as a result of bleeding, ulceration, or excessive mucosal congestion
* Patients with severe anemia or portal hypertension
* Patients diagnosed as having a mixture of the differentiated and undifferentiated types of gastric carcinoma, or having helicobacter pylori infection
Is Sensorimotor Training Effective Following a Distal Radius Fracture?

The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.

The study is an interventional study investigating the effectiveness of sensorimotor activities in addition to traditional occupational therapy intervention versus traditional intervention only for patients following a distal radius fracture with volar plate fixation. A convenience sample of patients from 2 outpatient orthopedic hand therapy departments will be invited to participate in the study.

The treatment for both groups will be identical with one group receiving the addition of sensorimotor activities. Participants will be divided into one of the two groups. They will be made aware that at any point they can choose to no longer participate in the study, and it will not affect their treatment.

Eligibility Criteria:
Inclusion Criteria:

* Distal radius fracture with volar plate fixation
* Understand English
* 18 years or older
* Available to attend skilled occupational therapy visits a minimum of 1x per week.

Exclusion Criteria:

* Prior surgery to the involved wrist/hand
* Cognitive impairment
* Distal radius fracture managed by casting or by another means of fixation
Chemotherapy, Hormone Therapy, and Surgery to Remove the Prostate Gland in Patients With High Risk Prostate Cancer

In men with prostate cancer who do not have evidence of spread to bone or other sites on computed axial tomography (CAT) scan/bone scan but are still at significant risk of failing treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy is being given for 6 months followed by surgery to remove the prostate.


Eligibility Criteria:
Inclusion Criteria:

* High risk prostate cancer without evidence of bone metastasis.