cyrilzakka/clinical-trials huggingface dataset:
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer

It is a trial to compare the efficacy and safety of Nab-paclitaxel plus Cisplatin vs Gemcitabine plus Cispatin as first line chemotherapy in advanced biliary tract cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 70 years;
2. Diagnosis of unresectable or recurrent or metastatic biliary tract cancer (Ampulla of Vater, gallbladder, intra or extra-hepatic biliary ducts);
3. Adequate bone marrow, liver and kidney function: absdute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelet count (PLT) ≥75 x 10\^9/L, hemoglobin (HB) ≥ 75 g/L, White blood cell(WBC) ≥ 3.0 x 10\^9/L, no bleeding symptoms or bleeding tendency; Total bilirubin (TBIL) ≤ 3 x upper limit of normal range (ULN), alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤ 5 x upper limit of normal range (ULN); creatinine(Cr) ≤ 1.5 x upper limit of normal range(ULN) or creatinine clearance rate（CCR）≥ 45ml/min;
4. At least one measurable lesion;
5. Karnofsky Performance Status(KPS) ≥ 70;
6. Estimated life expectancy of at least 3 months;
7. Resolution of all acute clinical toxic effects of any prior treatment to grade ≤ 1, with the exception of alopecia;
8. Be able to understand and willingness to sign IRB-approved informed consent; (If the patient cannot sign the informed consent due to consciousness disorder, upper limbs paralysis or inability to write, the legal representative shall sign the informed consent on behalf of the patient).

Exclusion Criteria:

1. Ongoing uncontrolled infections, or have received systemic antibiotic therapy within 72 hours prior to registration;
2. Myeloproliferative disorder or any other hematopoietic function disorder;
3. Have an untreated second malignancy or brain metastasis;
4. Allergic to the chemotherapy drugs of this protocol;
5. Unable to cooperate due to neurologic diseases or psychiatric illness;
6. Pregnant or lactating female patients; Women of child-bearing age who refuse to accept contraceptive measures;
7. Have other significant medical illness, for example,active tuberculosis, active pneumonia, uncorrected electrolyte disturbance, uncontrolled tumor associated pain, uncontrolled hydrothorax or seroperitoneum and so on;
8. Patients need to receive other antitumor therapy at the same time;
9. Have received any other experimental treatment or participated in another interventional clinical trial within 30 days prior to registration;
10. Any other situation that the researcher considered patients are unsuitable for the trial.
Investigation of Scapular Dyskinesia, Shoulder Mobilization and Serve Speed Variables in Asymptomatic Adolescent Tennis Players

Tennis is a sport where high performance, strokes and wide ranges of motion around the court must be created and high-strength movements are repeated repeatedly. Speed and control are important in terms of sportive performance during the serve throw in tennis. While these actions are taking place, a dynamic load that exceeds the physiological limits of the joint is placed on the shoulder. Disruption in the kinetic chain can cause injury to the shoulder. In this regard, the incidence of tennis injuries is approximately 21.5 injuries per 1000 training hours. The glenohumeral joint creates a wide range of motion for the shoulder and is also biomechanically related to the scapula. Scapular dyskinesia, the pathological position of the scapula, has been associated with common pathologies such as rotator cuff tears, labral tears, and shoulder impingement. Although there are studies with different opinions about the causality of scapular dyskinesia, the current literature has reported that scapular dyskinesia is indirectly associated with shoulder pain in overhead athletes. Achieving maximum shoulder performance in sports that require overhead activities such as tennis largely depends on the delicate balance between the scapula and the clavicle, humerus and rib cage joints. Tennis, which is an increasingly widespread sport in our country, exposes the shoulder joints to high stresses. If changes are not detected and necessary precautions are not taken, the shoulder structure may be at risk of injury. In the current literature review, no study was found that evaluated the relationship between scapular dyskinesia, shoulder mobility and serving speed in tennis players. The aim of our study is to evaluate the effects of scapular dyskinesia, glenohumeral joint mobility and posterior capsule tension on serving speed in tennis players. It is thought that the results to be obtained from our study will guide the creation of appropriate exercise programs in athlete training by determining the effects on sportive performance by determining the changes seen or to be seen in the shoulder complexes of tennis athletes.


Eligibility Criteria:
Inclusion Criteria:

* 12-20 ages
* Volunteer
* Does not have any cognitive, mental and psychological problems,
* Does not have any systemic diseases such as rheumatoid arthritis,
* Does not have any neurological problems,
* Additionally, the criteria for the tennis players included more than 1 years of tennis experience.

Exclusion Criteria:

* Having severe neurological, visual and auditory problems that may prevent the application of assessment parameters
* Children and their families who cannot obtain written consent from their families.
* Having communication problems
Clinical Performance and Wear Resistance of Highly Translucent Nano Zirconia Reinforced Glass Ionomer Filling Versus Conventional Resin Composite Restorations in Patients With Proximal Carious Teeth. (A One-year Randomized Clinical Trial).

This randomized clinical study aims to evaluate the clinical performance and occlusal wear resistance of nano-zirconia reinforced glass ionomer restorations in comparison to Nano-hybrid resin composite in proximal cavities.

Statement of the problem:

The glass ionomer restorations have a wide use in dental community. Proximal restoration is a challenge, due to the high forces present in this area that require more high fracture resistance restoration material which is not obtained in the most of the versions of glass ionomer restorations that are available in dental market.(Safy, 2019)

Rationale for choice of intervention:

Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor, zirconomer. Zirconomer is commercialized as a white amalgam as it features mechanical properties similar to amalgam restorations. In this generation also, translucency is improved to be similar to the tooth structure.(Shetty et al, 2017) As Zirconomer improved is reinforced material, it is expected that has high wear resistance than the conventional glass ionomer restorations. (Hesse et al., 2018)

Eligibility Criteria:
Inclusion Criteria:

* Age group 18-55
* Presence of occluding tooth.
* Good oral hygiene

Exclusion Criteria:

* Poor periodontal status
* Adverse medical history.
* Potential behavioral problems
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer

This study is a phase I clinical trial aimed to determine the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria specific to group 1:

- Patient with painful unilateral osteoarthritis of the knee as femorotibial pattern defined by a radiographic score of 0/1 from Kellgren / Lawrence and an average WOMAC score\> or equal to 4 and by minor disorders at MRI (MOCART 2.0 score\> 70).

Inclusion criteria specific to group 2:

* Patient with non-metastatic breast cancer, hormone receptor positive, HER2 negative, with indication for adjuvant therapy with aromatase inhibitor; treatment not yet started.
* Age \<60 years

Common inclusion criteria:

* Patient with at least 31 healthy joints (based on clinical assessment)
* signed written informed consent.
* Affiliation to a health insurance scheme.
* For women of childbearing age : negative serum pregnancy test at inclusion (less than 7 days prior injection of 99mTc-NTP 15-5).
* Willing and able to comply with study visits, treatment, exams and the protocol.

Exclusion Criteria:

* Patients \<18 years of age.
* Pregnant or lactating patient.
* BMI\> 30
* History of known allergy to excipients contained in the solution of 99mTc-NTP 15-5
* Chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthropathy, psoriatic arthritis, etc.) diffuse arthritis (at least 3 joints affected), autoimmune connectivitis, fibromyalgia.
* Known chronic joint pathology: osteoarthritis affecting at least 3 joints, autoimmune disease, inflammatory rheumatism (except unilateral knee arthritis).
* Persons deprived of their liberty, under guardianship / curatorship, or safeguard of justice.
* Treatment with NSAIDs or cessation of less than 48 h.
* Inability to comply with medical requirement / follow-up of the trial for geographic, family, social or psychological reasons. These conditions should be discussed with the patient before registration in the study.
Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses

To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 6-14 years old;
2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D\~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
3. Within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;
4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.

Exclusion Criteria:

1. Diagnosed constant strabismus;
2. Diagnosed pathological myopia;
3. Other congenital eye diseases;
4. Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
Distortion Product After Stapedotomy Surgery

This study aims at capturing for the first time at which frequencies and sound intensities hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

If the stapes footplate is fixed in position, e.g. by otosclerosis, rather than being normally mobile, a conductive hearing loss results. This conductive hearing loss is usually compensated with hearing aids or through stapedotomy. During stapedotomy, the diseased stapes bone is removed and is replaced with a piston prosthesis that conveys the sound stimulus from the incus to the footplate of the removed stapes.

After surgery subjects sometimes state that the quality of sound is suboptimal, even though their hearing ability has improved significantly. Some subjects subjectively hear distorted sounds, which often disappear several weeks after surgery.

This study aims at capturing for the first time at which frequencies and sound intensities these distortions are perceived. Additionally, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

Eligibility Criteria:
Inclusion Criteria:

* indication for stapedotomy
* written consent given

Exclusion Criteria:

* not mentally able to give written consent
Optimizing Current and Electrode Montage for Transcranial Direct Current Stimulation in Stroke Patients

The purpose of this study is to determine the optimal transcranial direct current stimulation (tDCS) amplitude and electrode montage that is both safe and efficacious

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate cortical excitability of targeted brain regions. Various studies have investigated tDCS use in stroke patients with motor impairments (cumulatively about 200 cases). Although these studies are mostly "proof of concept" with small sample size, they do suggest that tDCS may improve motor function. However these two questions have not been addressed systematically:

1. What is the optimal current for stroke patients?
2. What is the optimal tDCS electrode montage for stimulation?

This proposal lays the scientific foundation for systematic application of tDCS in stroke recovery research by progressively increasing tDCS currents and montages that are both safe and efficacious in population with stroke.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old with a first-ever ischemic stroke that occurred at least 6 months ago;
* Finished rehabilitation therapy(including inpatient or outpatient Physical Therapy (PT) / Occupational Therapy (OT) / Speech Therapy (SP)) at least one month ago;
* Unilateral limb weakness with Fugl Meyer-Upper Extremity Scale score less than 56 (out of 66);
* Motor Evoked Potentials (MEP) is inducible on abductor pollicis brevis (APB) muscle on the affected side by TMS.

Exclusion Criteria:

* Primary intracerebral hematoma, or subarachnoid hemorrhage,
* Bihemispheric ischemic strokes;
* History of prior stroke or old infarct demonstrated on the CT or MRI or documented in medical records;
* Other concomitant neurological disorders affecting upper extremity motor function;
* Documented history of dementia before or after stroke;
* Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
* Uncontrolled hypertension despite treatment, specifically Systolic blood pressure (SBP)/ Diastolic Blood Pressure (DBP) \>= 180/100 mmHg at baseline;
* Presence of any MRI/tDCS/TMS risk factors: a) an electrically, magnetically or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; b) non-fixed metal in any part of the body, including a previous metallic injury to eye; c) pregnancy, since the effect of tDCS on the fetus is unknown; d) history of seizure disorder or post-stroke seizure; e) preexisting scalp lesion, bone defect or hemicraniectomy.
High-intensity Interval Training and Vitamin D Effects on Bone Metabolism Among Women Diagnosed With Osteoporosis

The effects of 16-week high-intensity interval training (HIIT) and vitamin D supplements on bone mineral density (BMD) in women with osteoporosis. The participants assigned for HITT exercise training with or without vitamin D supplements for 16 weeks, and the levels of serum bone parameters like, Osteocalcin (OC), Ca, and s-BAP were estimated in women with osteoporosis at baseline and after post-training interventions. In addition, the levels of Vitamin D were also identified in all women's accordingly.

our study aimed to investigate the effects of 16-week high-intensity interval training (HIIT) and vitamin D supplements on bone mineral density (BMD) in women with osteoporosis. thus, Serum levels of 25-Hydroxy-vitamin D (OH-D), Osteocalcin (OC), Ca, and s-BAP were estimated in women with osteoporosis at baseline and after post-training interventions. One-hundred twenty sedentary women aged (30-50 years) were diagnosed with osteoporosis. Patients were classified into four groups, 30 patients in each group; Control group (normal daily activities); Exercise group (HIIT-exercise for 16 weeks); Vitamin D group (vitamin D 800IU/ day for 16 weeks), and Concurrent group (HIIT exercise plus vitamin D for 16 weeks). Anthropometric measurements, BMD, serum levels of vitamin 25-(OH) D, Osteocalcin, s-BAP, and calcium were estimated in all participants' pre- and post-exercise training.

Eligibility Criteria:
Inclusion Criteria:

* A healthy non-smoker premenopausal women's
* Age are 30-50 years old
* subjects who diagnosed with osteoporosis based on the clinical features of bone mineral density (BMD) measured from both lumbar spine L2 to L4, and from the right and left sides of the hip region by Dual Energy X-ray Absorptiometry (DEXA, UNIGAMMA PLUS AC 230V 50/60Hz 400w, USA) scan method.

Exclusion Criteria:

* Women with; physical disability,
* abnormal hormonal levels
* severe disease complications such as chronic kidney and liver diseases,
* rheumatoid and osteoarthritis diseases
* significant overweight (BMI ≥25) and obesity (≥30 kg/m2) per recommended by the World Health Organization
* history of receiving calcium, multivitamin supplements, corticosteroids, anticonvulsants, and heparin which might affects up on the assessment of bone markers and BMD measurements were excluded from this study.
Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients

The purpose of this study was to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.

This was a multi-center, non-randomized, open-label study in patients with high-risk neuroblastoma to assess the immunogenicity, safety and tolerability of Unituxin combination therapy. Patients enrolled in the study were prescribed Unituxin for the treatment of high-risk neuroblastoma.

Eligibility Criteria:
Inclusion Criteria:

* Patient had been diagnosed with high-risk neuroblastoma.
* Patient had been prescribed Unituxin and plans to start Unituxin therapy within 30 days of study entry.
* Patient started Unituxin therapy no later than 200 days after Autologous Stem Cell Transplantation (ASCT).
* Written informed consent / assent was obtained in accordance with institutional and International Conference on Harmonisation (ICH) guidelines.

Exclusion Criteria:

* Patient had received prior anti-disialoganglioside (anti-GD2) antibody therapy.
* Patient had participated in an investigational clinical trial with tumor therapeutic intent within 30 days of informed consent.
* Patient underwent Autologous Stem Cell Transplantation (ASCT) more than 200 days prior to receiving Unituxin therapy.
Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
* Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
* HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
* BMI (Body Mass Index) no higher than 45.0 kg/m\^2

Exclusion Criteria:

* Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
* Suffer from a life threatening disease (e.g. cancer)
* Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise \[for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner\])
Development of DBT/Parent Training Group Intervention

This treatment development study is aimed at developing and pilot testing a 24-week remotely delivered group intervention that integrates three evidence-based treatments: 1) Dialectical Behavior Therapy (DBT) Skills - targeting adult emotion dysregulation, 2) Parent Management Training (PMT) - targeting parenting behaviors linked to child behavioral dysregulation, and 3) Emotion Coaching (EC) - targeting parental emotion socialization practices linked to child emotion dysregulation.

The aims of the study are to:

1. Evaluate the feasibility of the intervention, specifically with respect to its acceptability and its implementation with 4 families in which a parent has elevated levels of emotion dysregulation and their child has elevated levels of emotion or behavioral dysregulation.
2. Examine change patterns in parent and child mental health and parenting quality using a Single Case Experimental Design (SCED) to evaluate both pre-post and weekly changes in these outcomes.


Eligibility Criteria:
Inclusion Criteria:

* parent must be 18+ years of age
* parent must have at least partial custody of a 3-6 year old child
* neither parent nor child may have any known developmental disability
* parent must be proficient in English
* parent must endorse elevated emotion dysregulation and report their child meets a cutoff for emotional and/or behavioral difficulties.
* parent must have access to the internet and Zoom software

Exclusion Criteria:

* parent with developmental disability
* psychotic disorder
* actively suicidal with an active plan