cyrilzakka/clinical-trials huggingface dataset:
Lower Extremity Neuromuscular Assessment in Children with Cerebral Palsy

The purpose of this study is to evaluate the reliability (intra-rater and inter-rater) of the K-Pull dynamometer and the K-Myo non-invasive electromyography sensor (assessing neuromuscular activity) in the evaluation of the lower limbs in children with cerebral palsy.

Specific objectives include:

* Examining differences in neuromuscular activity among children with CP classified at functional levels I to III on the GMFCS scale.
* Deriving conclusions from the correlation between electromyographic activity, muscle tone, and generated muscle strength.
* Assessing the applicability of neuromuscular activity assessment devices in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* children with spastic type cerebral palsy (CP),
* aged between 5 and 16 years,
* classified at GMFCS levels I to III,
* voluntary motor control,
* ambulatory, with or without the use of mobility aids,
* can understand and execute verbal commands.

Exclusion Criteria:

* have previously undergone interventions that affect neuromuscular performance (such as surgery or botulinum toxin injections)
* have sustained an injury,
* demonstrate a low level of compliance.
Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining carboplatin and topotecan in treating patients with relapsed acute myelogenous leukemia.

OBJECTIVES: I. Determine the efficacy of a 5-day continuous infusion of carboplatin and topotecan in patients with relapsed and refractory acute myelogenous leukemia (AML). II. Assess the toxic effects of this treatment in these patients.

OUTLINE: Patients receive continuous intravenous infusions of topotecan and carboplatin for 5 days. Treatment repeats every 3-4 weeks during induction (two courses) and every 6-10 weeks during consolidation. No more than four courses of treatment are given. Patients are followed every 6 months for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Previously established diagnosis of acute myelogenous leukemia: Failure to achieve a complete remission with initial induction regimen First relapse within 1 year of initial complete remission Failure to achieve complete remission with one or two courses of reinduction therapy at first relapse Second relapse after no more than two different induction regimens Chemotherapy-related leukemia with unfavorable cytogenetics No active CNS leukemia Not eligible for allogeneic bone marrow transplant from related donor

PATIENT CHARACTERISTICS: Age: 18 to 74 Performance status: ECOG 0-2 Life expectancy: At least 4 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than upper limit of normal (ULN) (unless elevation due to AML) Renal: Creatinine no greater than 0.3 mg/dL above ULN Cardiovascular: No myocardial infarction within the past 3 months No congestive heart failure No poorly controlled cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use adequate contraception No psychosis No active systemic infections

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from the toxic effects of previous chemotherapy At least 3 days since hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior or concurrent aminoglycosides or amphotericin B within past 7 days
Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma

The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.

This was a multicenter, double-blind, randomized, phase 2 study of pegfilgrastim given either the same day as or the day after a chemotherapy regimen consisting of cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP).

Chemotherapy was administered every 21 days for up to 6 cycles in subjects with aggressive non-Hodgkin's lymphoma (NHL; mantle cell or diffuse large B-cell lymphoma). Subjects were administered R-CHOP on day 1 of each cycle. All subjects were randomized to 1 of 2 treatment arms: arm A subjects were administered pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion); arm B subjects were administered pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion). All subjects were administered placebo on the day they did not receive pegfilgrastim. A total of 77 subjects were enrolled at 24 centers across the US. Protocol treatment duration for subjects was up to 18 weeks (6 three-week cycles).

Eligibility Criteria:
Inclusion Criteria: - Histologically proven mantle cell lymphoma or histologically proven diffuse large B-cell non-Hodgkin's lymphoma (NHL) according to the REAL classification - Measurable and/or evaluable disease - Previously untreated patients Exclusion Criteria: - Burkitt's or B-lymphoblastic lymphoma - Central nervous system (CNS) involvement - Active infection requiring treatment with systemic anti-infectives within 72 hours of chemotherapy - Prior malignancy within the last 5 years - T-cell lymphoma or history of indolent lymphoma - Prior bone marrow or stem cell transplantation - Known sensitivity to E. coli derived drug products
To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand

Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request).

The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses).

The protocols will be used for the first 48 hours following surgery.


Eligibility Criteria:
Inclusion Criteria:

* women that underwent cesarean section

Exclusion Criteria:

* Women suffering from chronic pain
* Women using chronic pain medications
* Allergy to any drug used in the study
* Women underwent general anesthesia during the surgery
* women with elevated liver enzymes
UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma

Traditional ciliary body photocoagulation treatment uses the photocoagulation of long-wavelength laser to destroy the ciliary body tissue that can produce aqueous humor. Therefore, it is a kind of palliative treatment which has proved efficacy but causes great pain to patients. The "ultrasonic glaucoma treatment instrument" produced by French EYE TECH CARE company is referred to as EyeOP1. It uses high-intensity focused ultrasound technique to make target part of the ciliary coagulative necrosis, reduce the production of aqueous humor and thereby lower the intraocular pressure. EyeOP1 is ergonomic and suitable for the human eye, making the treatment process more accurate, simple and fast.

1. Efficacy: 1. Main objective: (1)Assess the decrease in postoperative intraocular pressure from baseline and evaluate the final results (the percentage of patients whose conditions have significant improved and the variation of the percentage of median intraocular pressure. (2)Assess the amount of medication after surgery.
2. Secondary goals:(1) Compare median intraocular pressure with baseline at each postoperative follow-up and access the variation of median intraocular pressure from baseline at each postoperative follow-up. (2) Count the number of intraocular pressure lowering drugs at each postoperative follow-up.

b.Safety: Investigate the incidence of all device-related(or procedure-related) adverse events during the study (intraoperative and postoperative follow-up).

Eligibility Criteria:
Inclusion Criteria:

* The target eye was diagnosed as primary open-angle glaucoma; diagnostic criteria: IOP(intraocular pressure)≥ 21, open angle, typical glaucoma visual field and optic disc damage;
* Patients treated with glaucoma medications cannot control intraocular pressure effectively;
* Patients with 21mmHg ≤ IOP ≤ 30mmHg;
* VA(visual acuity)≥HM(hand motions);
* Patients that have failed conventional glaucoma surgery (trabeculectomy) or are not suitable for surgery;
* Patients who have not received intraocular surgery or laser treatment 90 days before receiving HIFU;
* Aged from 18 to 90 years old;
* Sign informed consent and be willing to provide visit data;

Exclusion Criteria:

* Either eye have any infections two weeks before the surgery;
* The target eye has history of ciliary surgery, intraocular or retrobulbar tumor;
* The target eye is neovascular glaucoma;
* The target eye is aphakic eye;
* Anterior anatomical abnormalities cause scleral expansion or ciliary body ectopic;
* Non-glaucoma intraocular diseases that affect intraocular pressure;
* Within 30 days, the patient participated in or was simultaneously included in other clinical trials;
* Patients during pregnancy or lactation;
* Any systemic disease that may affect patient follow-up.
In-hospital and Post-discharge Training of Older Medical Patients

The project aims to investigate the clinical value of simple strength training during hospitalization and after discharge as part of an enhanced recovery programme for acutely admitted older medical patients, in order to prevent mobility decline following acute hospitalization.

Note 11/23/16: As noted in the protocol (doi: 10.1186/s13063-016-1309-1) we have obtained funding and ethical approval (H-2-2012-115/09-12-2016) to extend the study to achieve sufficient power to look more deeply into our secondary outcomes. This will constitute a secondary part of the trial (started Nov. 2016). The primary trial report will include data for the pre-specified sample size for which the last patient was assessed Oct. 2016. Hence, the primary completion date for part 1 was April 2016 and the study completion date for part 1 was Oct 2016. The trial status is still "recruiting" although this applies to part 2 of the study.


Eligibility Criteria:
Inclusion Criteria:

* \>=65 years of age
* admitted from own home

Exclusion Criteria:

* Terminal illness
* In treatment for diagnosed cancer
* Assigned to physical rehabilitation in community
* Chronic Obstructive Pulmonary Disease (COPD) patients participating in organized rehabilitation
* Living outside of the municipalities of Copenhagen and Broendby
* Not able to talk and understand danish
* Not able to cooperate on tests/exercises
* Hospitalized \< 24 hours
* A Cumulated Ambulation Score (CAS) of 0 in the sit-to-stand item
Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer

A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy

Ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. Serum cancer antigen 125 (CA125) is widely used in ovarian cancer. An elevation in CA125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18F-FDG PET/CT can modify management in approximately half of these patients. However. 18F-FDG PET/CT may yield false negative results. 68Ga-FAPI-46 PET/CT shows potential here. This study is to assess the diagnostic performances of 68Ga-FAPI-46 and 18F-FDG PET/CT for ovarian cancer recurrence in patients with CA125 elevation from complete response after therapy.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven ovarian cancer with complete response after therapy
* Age between 30 and 80
* Elevation of serum CA125 value above the normal range (\>35 U/mL) or doubling of serum CA125 value within the normal range
* ECOG performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed
* Willing to enter this prospective study with signed informed consent form

Exclusion Criteria:

* Patients with history of other malignancy
* Patients who are pregnant or lactating
* Patients with fasting fingerstick glucose level higher than 200 mg/dl
* Known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68Ga-FAPI-46 or 18F-FDG imaging studies
* Patients who are incapable of lying still for 30 minutes to receive the PET/CT scan as assessed by investigators
Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration

The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal Spray as compared to an IM injection of cyanocobalamin (European reference product).

This is an open-label, randomized, single-dose, two-way crossover study. The study consists of a screening visit, two 4-days confinement periods and a follow-up telephone call. The two confinement periods will be separated by a washout period of at least 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male voluteers
* 18-40 years of age
* BMI between 18.5 and 30.0 kg/m2

Exclusion Criteria:

* Females who are pregnant or lactating
* History of clinically significant metabolic, hepatic, renal, haematological, pulmondary, cardiovascular, gastrointestinal, urological, neurological or phychiatric disorders
* Serum vitamin B12 \<=250 pmol/L or MMA \>=0.40 umol/L
* Evidence of significant intranasal pathology
* Nasal congestion, allergic rhinitis or upper respiratory tract infection
Predictors of Non-accESs to therapeutiC EducAtion Programs Among Patients With Type 2 Diabetes, and/or Asthma, and/or Chronic Heart Failure in an Emergency Setting

Chronic diseases are frequent and potentially severe. Type II diabetes, asthma and heart failure affect 3.3 million, 4 million and 1 million people respectively in France. They are sources of avoidable mortality as well as disabilities leading to a loss of years of full health life (DALYS). Cumulatively, they were responsible for the loss of more than 1 million DALYS in 2019 in France. National and international recommendations also include TVE in the management of these three diseases.

This severity can be reduced by better management underpinned by therapeutic education. By improving their knowledge of the disease, it allows a better adherence of patients to the care project, the achievement of clinical and biological objectives, a decrease in the number of emergency room visits and unscheduled hospitalizations, and an improvement in the quality of life during the course of three frequent chronic diseases such as type 2 diabetes, asthma and heart failure.

However, participation in a therapeutic education program remains highly variable depending on many parameters. Lack of information seems to play a major role in this context.

In the Ile de France region, the density of available TEP programs is high, particularly in Paris. The three chronic diseases that are managed by an advanced practice nurse with a PCS mention have the largest number of TVE programs in Paris: type 2 diabetes (32, and 6 for diabetic foot), asthma and heart failure.

In an urban area with a good supply of TVE facilities, how can investigators explain the lack of integration of these facilities into the care pathway? Among the diverse patient population consulting an emergency department suffering from type II diabetes, asthma or heart failure, investigators wish to determine the proportion of patients who have not been offered TVE during their care.

Investigators will then try to identify demographic, socioeconomic, and medical factors statistically associated with the absence of FTE proposal.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patient consulting the GHPSJ emergency department for any reason
* Patient with a chronic disease among type 2 diabetes and/or asthma and/or heart failure
* Francophone patient

Exclusion Criteria:

* Diagnosis of the chronic disease in the context of its current management in the emergency room
* Patient being followed outside of Ile de France for the chronic disease studied
* Patient with dementia or cognitive disorders
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under legal protection
* Patient opposing the use of his data for this research
Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.

Use of informed algorithm for patients selection of prophylactic mesh aplication after midline laparotomy in emergency surgery.

Midline laparotomy complications have a high rate. When midline laparotomy is performed complications rate is even higher. One of the commons complications is incisional hernia, reaching up to 40%- 50% of cases in High risk groups.

Prophylactic mesh use has been proved to be useful preventing midline laparotomy in elective surgery. Despite this, there is not enough data to recommend its use in emergency surgery.

Aim of the study is to investigate if use of an algorithm of informed decision for use of prophylactic mesh in emergency midline laparotomy reduces incisional hernia incidence.

Prospective cohort study of all consecutive midline laparotomy performed at our emergency surgery department. Compare correct application of algorithm outcomes versus non correct application.

Eligibility Criteria:
Inclusion Criteria:

* Emergency midline laparotomy.

Exclusion Criteria:

* Surgical infection present at the moment of surgery.
* Ventrla or incisional hernia present at the moment of laparotomy .
* Open abdomen.
* Preoperative American Society of Anesthesiologist score (ASA) of V.
Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test

This is a diagnostic validation study for a combined Syphilis/HIV test made by MBio Diagnostics, Inc (MBio, Boulder, CO, USA). Although the MBio Syphilis/HIV diagnostic platform is designed for use at point of care (POC), it is made to provide similar performance as reference standards. Diagnosing HIV and syphilis accurately with a single POC test will save time for clinic health workers and technicians, reduce loss-to follow-up caused by lengthy delays for lab-based tests, and save costs by eliminating the need for multiple tests. For this study, the sensitivity and specificity of the MBio HIV/Syphilis Serology System point-of-care diagnostic test will be determined using reference tests performed under controlled laboratory conditions. For this, clients receiving routine care in the ANCs at the New Nyanza Provincial General Hospital (NNPGH) and Kisumu District Hospital (KDH) will be consented to provide blood for the proposed study. Study volunteers will receive HIV and syphilis rapid tests provided as part of routine care, and will donate an additional blood for evaluating the MBio test against the reference tests in a laboratory setting. This study is an investigational prototype, not for product registration. The results from this study will be used to inform product development of a second iteration of the MBio device design. At the time that the device is ready to be registered, it will undergo another field evaluation at which time it will be submitted to the appropriate regulatory body. Because the MBIO device is an HIV test, the device would be submitted to National AIDS \& STI Control Program (NASCOP), which is the appropriate regulatory body for HIV tests in Kenya.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Attending her first routine ANC visit and willing to undergo tests for HIV/syphilis
* Able and willing to legally consent for enrollment
* Able to demonstrate-comprehension of study details as they are explained in the consent process by passing all the test questions of understanding. The subject is only allowed two attempts at passing the test of understanding.

Exclusion Criteria:

* Unwilling to provide written informed consent.
* Unable to legally consent (minor without guardian)
* Opt out of HIV or syphilis test
* Previously diagnosed with autoimmune disorder (lupus, Lyme disease), as determined by client recollection or clinical record.
Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition

This study will investigate the clinical performance of a novel restorative glass ionomer (DeltaFil, DMG) in comparison to an established restorative glass ionomer (Riva Self Cure HV, SDI) in the restoration of Class II cavities in primary molars.

Dental caries (tooth decay) remains one of the most prevalent diseases worldwide. It is a dynamic and continuous process that, if uncontrolled, eventually leads to cavitation and the need for restorative treatment to maintain the form and function of the tooth.Today there are many possibilities for direct restorations, e.g. resin composites, compomers, resin-modified glass ionomer cements (RMGICs) and glass ionomer cements (GICs), which all offer their own advantages and disadvantages.

GIC are particularly suitable for treatments in young patients due to their high biocompatibility, fluoride release, less moisture and technique sensitivity as well as compatibility with Atraumatic restorative treatment (ART) treatment. However, these materials have lower mechanical properties compared to other restorative materials, which negatively affects the survival rate when placed in load bearing areas. Fracture, loss and wear being the most common causes for failure.

This randomized, controlled non-inferiority trial aims to evaluate the performance of the new restorative glass ionomer DeltaFil, that offers an increased fracture toughness, in comparison to an established restorative glass-ionomer (Riva Self Cure HV).

Eligibility Criteria:
Inclusion Criteria:

* At least 1 and up to 3 primary molars with either International Caries Detection and Assessment System (ICDAS) lesions stage 2-5 or preexisting restorations requiring placement/replacement of Class II restorations
* Defects limited to occlusal-proximal surface, with cavity sizes smaller than 3 mm mesio-distally and 3 mm in the occluso-cervical and bucco-lingual directions measured with a World Health Organization (WHO)-graded periodontal probe
* Teeth should have both adjoining and their antagonist teeth present. After restoration the restored tooth should enable appropriate proximal contacts on both mesial and distal surfaces after setting of the class II restoration and be in occlusion with the antagonist tooth
* Good access
* Good general health (ASA I, II)
* Good oral hygiene (OHI-S \< 1.9)
* Guardians have given informed consent
* Child is cooperative and assented

Exclusion Criteria:

* Known allergy/ sensitivity to GIC or other materials used in this study
* Space maintainers or orthodontic appliances
* Tooth has a caries lesion or restoration other than those included in the study
* Tooth has pathological mobility
* Tooth has preexisting developmental defects
* Tooth with pulp exposure or indication for endodontic treatment
* Pain, fistula or abscess related to the selected tooth
* Obvious signs of parafunctional habits (e.g. bruxism)
* Participation in another study
* Incapable to participate in the recall visits at the university hospital