cyrilzakka/clinical-trials huggingface dataset:
Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects

The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.

The surgery performed will be the same for all patients

The length of follow up and schedule of post-operative MRI will be the same for all patients.

The only difference in groups will be presence of absence of brace wear.

The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.

The surgery performed will be the same for all patients

The length of follow up and schedule of post-operative MRI will be the same for all patients.

The only difference in groups will be presence of absence of brace wear.

Eligibility Criteria:
Inclusion Criteria:

* isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
* age 15-40
* neutral knee alignment

Exclusion Criteria:

* prior cartilage procedures performed in the same knee
* other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis
Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment

The structural and functional alterations of high density lipoproteins (HDL) levels in type 2 diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance, inflammation and oxidation, play a major role in the increased macrovascular risk in these patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL concentrations.

Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the impact of HDL increasing drugs on HDL qualitative changes.

Groups of subjects: a) Diabetic patients with low HDL; b) Non-diabetic patients with low HDL; c) Diabetic patients with normal HDL levels; and d) Non-diabetic patients with normal HDL levels. The studies will be performed after washing out lipid lowering drugs. Intima media thickness (IMT) will be performed in all groups. Main biochemical techniques will be centralised. Isolation and characterisation of HDL subclasses and remnant HDL, as well as a determination and preβ1 HDL will be performed. HDL studies examining HDL proteomic and metabolomic profiles will be performed. Functional studies will determine the effects on the endothelium, inflammation, cholesterol efflux and oxidation according the qualitative changes. These HDL measurements will be repeated in group (a), after they are treated with fibrates or Niacin. HDL metabolism in adipocytes will be extensively studied, and the clinical associations between HDL alterations and plasma AT-derived molecules will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients
* Age from 30 years to 70 years
* HDL not exceeding 50 mg/dl in men or 60 mg/dl in women

Exclusion Criteria:

* to be a smoker
* To be diagnosed with diabetes less than three months before
* To have triglyceride levels above 400 mg/dl
* Glycated hemoglobin higher than 9%
* Albuminuria above 300 mg/mg creatinine
* Chronic kidney disease (eFGR \<30 ml/min/1.73 m2)
* Advanced retinopathy
* Neuropathy
* Cardiovascular disease in the last three months
* Chronic liver insufficiency
* Neoplastic disease or any chronic or incapacitating disease
A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects

To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron Deficiency Anemia.


Eligibility Criteria:
Inclusion Criteria:

* An iron deficiency anemia patient with Serum Ferritin \< 12 ng/mL, serum Hb-values \>60 and \< 120 g/L in males, \< 110 g/L in females

Exclusion Criteria:

* With any Mal-absorption Syndrome
* With a history of Thalassemia or Sickle Cell Anemia
* With untreated concurrent Vitamin B12 or Folate deficiency at Baseline
A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-SELECT)

Several studies suggest that advanced multi-modal imaging with CTP should be used to screen late time window stroke patients for thrombectomy. However, NCCT is more accessible when comparing with CTP. It is unclear whether the NCCT-based ASPECTS can be used as an imaging criterion to screen patients for thrombectomy.

The newly published MR CLEAN-LATE and TENSION trials used NCCT or CTA, but still relied on ASPECTS scores to evaluate and select patients for endovascular therapy. However, different trials have different time windows. The aim of this trial was to assess the clinical outcomes of stroke patients with anterior large vessel occlusion who selected by simple imaging (NCCT) comparing via standard imaging screening strategy (CTP/MRI). The hypothesis is that simple imaging is non-inferior to standard imaging selection strategy in terms of achieving favorable outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older;
2. The interval time from last known well to hospital arrival is within 24 hours;
3. Acute stroke confirmed by clinical symptoms or imaging examination;
4. Field Assessment Stroke Triage for Emergency Destination (FAST ED) ≥4;
5. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

1. Allergy to radiographic contrast agents, or nitinol devices;
2. Currently pregnant or lactating (women patients);
3. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
4. Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
5. Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
6. Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
7. Intracranial aneurysm, arteriovenous malformation;
8. Any terminal illness with life expectancy less than 6 months;
9. Unlikely to be available for 90-day follow-up.
Effects of Physical Therapy on the Multisystems of Children With Cerebral Palsy: a Longitudinal Study

Cerebral Palsy (CP) refers to childhood movement and posture disorders, whose severity, patterns of motor involvement and associated impairments are very varied. It is the most prevalent type of physical disability in children. Any non-progressive central nervous system (CNS) lesion that occurs in the prenatal, perinatal and postnatal period up to 2 years of life is considered CP. Thus, the present work aims to evaluate, monitor and verify the effects of physical therapy interventions on gross motor function, spasticity, balance, muscle activation, fatigue, respiratory system, functionality and social participation in children with cerebral palsy. This work will use some evaluation scales such as the Gross Motor Function Measure (GMFM-66), the Modified Ashworth Scale (MAS), the Early Clinical Assessment of Balance (ECAB), electromyography, the Fatigue Severity Scale and the Pediatric Functional Status. Scale. In addition to questionnaires, which will be applied directly to parents/caregivers, such as the Young Children's Participation and Environment Measure (YC-PEM), the PEDI (Pediatric Evaluation Disability Inventory) and the Goal Attainment Scaling (GAS).


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Cerebral Palsy
* aged between 0-12 years
* classified in all the levels of the GMFCS
* those responsible agree to release the minor to participate in the study and sign the Free and Informed Consent Form (FICT)

Exclusion Criteria:

* have had botulinum toxin applied 6 months before the intervention
* recent surgery
* other physical abnormalities, genetic or severe syndromes.
A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy
* ECOG Performance status 0-1
* Adequate organ functions
* Measurable disease

Exclusion Criteria:

* Suspected or known CNS metastasis
* Participants with active, known, or suspected autoimmune disease
* Uncontrolled or significant cardiovascular disease
* Prior exposure to selected immune cell-modulating antibody regimens
Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care

The primary objective is to investigate differences in the alcohol consumption pattern between alcohol addicts receiving conventional treatment and those who receive a combination of conventional treatment and TripleA.

The study is a 12-month open-label and randomised comparison between the control group receiving only conventional treatment and the intervention group receiving conventional treatment enhanced with TripleA.

The studies have been designed to reflect as far as possible the conventional care for alcohol dependence. The TripleA product is intended to strengthen the existing methods used during the assessment phase, treatment phase and aftercare of alcohol dependence.

Eligibility Criteria:
Inclusion Criteria:

* Patients in care at Addiction and Neuropsychiatry Uppsala University Hospital and at Nämndemansgården Uppsala
* 18 years or older
* Meets at least 2 of the criteria for addiction/substance syndrome according to Diagnostic and statistical manual of mental disorders-5 (DSM-5)
* Ability to understand and communicate in Swedish
* Ability to handle the technical equipment used in the study (alcoholometer and Smartphone)
* Access to a fixed place (living, place for sleeping, place where the phone can be charged

Exclusion Criteria:

* Schizophrenia
* Substance syndrome related to other substances than alcohol and nicotin
* Lowered lung function (not able to reach acceptable expiration volume for the alcoholometer function)
* The patient is taken care of within the frame for The Act on Care of Addicts
* Not suitable to participate according to the Investigator
* Has not consumed any alcohol during the 4 weeks defined as baseline timeline follow back
* Normalized Carbohydrate Deficient Transferrin (CDT) and Phosphatidyl-Ethanol (PEth)-values in blood samples at visit 1
Energy CT in Imaging and Diagnosis of Gastric Cancer

Accurate preoperative prediction of risk stratification, treatment response, and survival prognosis in gastric cancer is important for improving clinical treatment decisions, prolonging patient survival, and improving patient quality of life. The purpose of this study is to investigate the performance of the multi-parametric magnetic resonance imaging (mpMRI) and Dual-/Muti-energy CT and photon-counting Detector CT(PCD-CT) in the diagnosis and management of gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological biopsy confirmed gastric cancer;
2. Surgery: patients undergoing radical gastrectomy. Patients undergoing exploratory abdominal surgery or palliative tumor resection were still included in the study when peritoneal metastasis or adjacent organ invasion was identified intraoperatively and radical surgical resection was not possible.

Exclusion Criteria:

1. Refusal or inability to sign informed consent;
2. CT or MRI images are poor or the focus is small and CT images are not clear;
3. Patients with other tumors complicated with patients with important organ dysfunction.
Benefits of Tablet-based Serious Games to Promote Speech Production in Young Children With Hearing Disabilities

Learning to speak is a major challenge for children with hearing impairments. Nowadays, special devices such as conventional hearing aids, bone-anchored hearing aids (BAHA) or cochlear implants (CI) allow successful rehabilitation of patients with hearing disabilities. To obtain maximum benefit from these technical aids, instrumented hearing impaired children require specific and intensive speech therapy to compensate for speech development delays. In addition, it is also of primary importance that during daily life (e.g., at home, at school) children are provided with sufficient and good quality auditory stimulation.

The main goal of this project is to encourage speech production with an edutainment tool that can be used at home and that is adapted to the specific needs of young hearing impaired children. For this purpose, the investigators have recently designed an innovative educational solution: FunSpeech, a tablet-based set of video games that respond exclusively to sound and speech. The aim of this serious game is to encourage hearing impaired children to produce controlled sounds in terms of rhythm, intensity, and pitch. These are the main abilities required for controlled speech production. Finally, this serious game aims to support the parents' key role in the speech learning process by offering an effective solution that is easy to use at home with young children.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mild to profound hearing loss,
* Optimum instrumented hearing (hearing aids, BAHA or CI),
* Language development delay confirmed by a speech therapist,
* Enough sensorimotor, cognitive and communication skills to play with tablet-based games,
* French mother tongue

Exclusion Criteria:

* Additional impairments which affect language development or the use of FunSpeech (e.g. motor, orofacial, sensory, cognitive),
* Refusal of the participant's representative(s) to participate in the study,
* Refusal of the participant's representative(s) to participate in a modality of the study,
* If the child/participant refuses to collaborate in two measures of language level.
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, DCF) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.

This study was designed as a single arm, phase II trial. Subjects will receive 3 cycles of Sintilimab combined with DCF as neoadjuvant therapy. The primary endpoint is pathologic complete response(pCR).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old and ≤75 years old
* Esophageal squamous cell carcinoma diagnosed biopsy histopathology
* The primary tumor is located in the middle of the esophagus and T1b-3N1-3M0 /M1 or T3N0M0 diagnosed by CT/MRI/EUS (AJCC 8th)
* At least one measurable lesion
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1
* With adequate organs function

Exclusion Criteria:

* Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
* Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
* Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
Medium-Term Follow-Up of Alpha-D Cervical Disk Prosthesis

Prostheses use subsequently became prevalent and a number of studies were conducted. However, prosthesis-associated heterotropic ossification (HO) in the segments with prostheses was reported in 2005, which disrupted mobility and caused fusion.

In the present study, we aimed to investigate the clinical outcomes, HO incidence, and prosthesis mobility in the patients following the operative use of Alpha-D disc prosthesis as developed and used by the authors to treat cervical disk diseases.


Eligibility Criteria:
Inclusion Criteria:

* cervical disc hernia
* underwent cervical discectomy and received cervical disc prostheses

Exclusion Criteria:

* history of cervical surgery,
* kyphotic deformity,
* rheumatological or other systemic diseases,
* severe osteophytes caused by advanced degenerative disc disease
* severe spinal stenosis
A Study of TRK-950 in Patients with Advanced Solid Tumors

The main purpose of this study is to determine the safety and tolerability of TRK-950 alone and in combination with Nivolumab in patients with advanced solid tumors

This is an open-label phase I study and consists of two parts. In the Part 1, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists will receive two dose level of TRK-950. In the Part 2, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with Nivolumab 240 mg alone administered at 2-week intervals will receive two dose level of TRK-950 in combination with Nivolumab. The objectives of this study are to determine the safety, tolerability, pharmacokinetic (PK) profile and the incidence of the development of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against TRK-950.

Eligibility Criteria:
Inclusion Criteria:

* Part 1: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists. Part 2: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals.
* Patients with life expectancy of at least 3 months after the start of study drug administration
* Patients aged \>=18 years at the time of consent
* Patients who are able to provide written consent in person to be a subject of this study
* A negative pregnancy test before enrollment (if female of childbearing potential)

Exclusion Criteria:

* Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
* Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed)
* Patients who are unwilling or unable to comply with the protocol specified procedures
* Patients who are positive for human immunodeficiency virus (HIV) antibody
* Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing

  * Patients who are positive for hepatitis B surface antigen (HBsAg)
  * Patients who are positive for HCV RNA
The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes

A randomized controlled study to evaluate the effect of 3 months use with interactive computer game- "My Diabetic Friend"- comparing to conventional diabetes education on metabolic control, quality of life and diabetes knowledge.Patients will be randomized into two groups- one group will be supplied with interactive computer game, "My Diabetic friend", installed on a computer designed for children's educational needs for a period of three months and the other group will be supplied with the same computer without the interactive computer game for three months. Metabolic control, quality of life and diabetes knowledge will be evaluated before and after the use of the computer.

The trial is consisting of two main periods: 3 months of the main study period and an optional extension period consisting of the following 3 months :

The study will include two main periods;

1. Period 1 which will last 3 months, in a randomized controlled manner, this period will serve as the main study period to assess the primary and secondary endpoints of the study.
2. Period 2: this extension period will not be an integral part of the study, and only patients who are willing will take part at this period, will continue to participate at the optional extension period. During the extension period, patients in the intervention group will be offered to continue the use of the Computer game -"My diabetic friend) for the following 3 months, and patients who participated at the control group during period 1, will be offered to start to use the Computer Game - "My Diabetic Friend" for the following 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes diagnosed at least one year prior to study entry.
2. Age:7-11 years old.
3. Treatment either with CSII or MDI.
4. HbA1c\>8.0%
5. Signing an informed consent form.

Exclusion Criteria:

1. Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to affect subject compliance or subject's ability to complete the study.
2. Inability to understand/ complete the questionnaires.