cyrilzakka/clinical-trials huggingface dataset:
Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome

The purpose of this study is to examine the effects of eccentric exercise to the shoulder muscles for people with shoulder pain. Identifying specific exercise protocols for individuals with shoulder pain will provide evidence to help clinicians select the best interventions.

Prior investigations for eccentric training of the shoulder have primarily utilized a pain provocation model for exercise progression. This method of progressing resistance training load and volume assumes that pain must be increased during the exercise movement for clinical benefit to occur. When the individual reports a reduction in pain, load is increased so that the provoking pain level returns. The contrast to this approach would be a performance based progression as utilized in the Blume et al study for shoulder eccentric training. This method progresses a patient based on ability to perform a higher number of repetitions at a given load without increasing symptoms which could be favorable in many clinical settings.

Further investigation on the role of eccentric training, specifically to the shoulder external rotators, in patients with SAPS is warranted. Thus, the aim of this investigation was to compare outcomes, for individuals diagnosed with SAPS, performing a six week protocol of eccentric training to the shoulder external rotators compared to a general exercise protocol.

Eligibility Criteria:
Inclusion Criteria:

* Presence of non-acute shoulder pain (greater than 3 months duration)
* 3 out of the 6 following tests positive, Neer impingement, Hawkins-Kennedy impingement, empty can test, resisted external rotation test, palpable tenderness at the insertion of the supraspinatus or infraspinatus, and painful arc from 60° to 120° during active abduction.
* Age over 18 years old
* Sufficient ability to read English as required for completing questionnaires

Exclusion Criteria:

* Red flags noted in the patient's Medical Screening Questionnaire (MSQ) (ie. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use)
* Full thickness supraspinatus or infraspinatus tendon tear as determined by a positive drop arm test, lag sign or rent test.
* Shoulder adhesive capsulitis as evidenced by a limitation in passive motion for all shoulder planes of movement.
* Having an upper extremity amputation.
* Individuals having a history of surgery to the cervical spine or involved upper extremity for a musculoskeletal, neurological or dermatological condition for which they are at the time of data collection receiving post-operative care.
* Pending legal action regarding their shoulder pain
* Inability to comply with treatment and follow up schedule
* Insufficient English language skills to complete all questionnaires
Nasal Intubation：a Comparison of Different Endotracheal Tubes

Either uses two different endotracheal tubes to pass the nasal cavity and to compare the effects on the secretion and bleeding volume of patients during intubation to facilitate nasotracheal tube advancement.

1. Assess the patient's airway before intubation. EKG, blood pressure and SPO2 are monitored during the process.
2. Randomly divided into two groups：Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal tubes.
3. Sedation process：Give Fentanyl 1 ug/kg according to the patient's weight via IV.
4. Give 1.5ml of Lidocaine without Epinephrine and 0.5ml of Lidocaine with Epinephrine to reduce intranasal bleeding.
5. Sedative injection：give Fentanyl 1ug/kg + Thiamylal 5mg/kg + Rocuronium 1mg/kg
6. Anesthesia intubation inducer：Propofol 1mg/kg
7. Intubation
8. Record the bleeding of the oropharyngeal and nasal mucosa、intubation time、Intubation Difficult Scale (IDS score) and number of intubations during intubation.
9. Record oropharynx、nostril and oropharynx bleeding in 3 minutes after completion of intubation.
10. Evaluate the patient's sore throat, hoarse voice, dysphagia, nasal congestion, nose bleeding, and nasal pain every other day.

Eligibility Criteria:
Inclusion Criteria:

* Age:20-65 years
* Undergoing oro-maxillofacial surgery
* Opening mouth \> 3 cm
* Denied any systemic disease.
* American Society of Anesthesiologists (ASA) class:I-III

Exclusion Criteria:

* Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance \< 6cm)
* Previous head and neck surgery history
* Upper abnormal airway diagnosed
* Easily epistaxis
* Both sides nasal cavities obstruction
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

The purpose of this study is to evaluate patients with tibial plateau fractures.

The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins.

Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and above (adult population)
* All open and closed tibial plateau fractures

Exclusion Criteria:

* 17 years of age and less (pediatric population)
* Quadriplegic patients
* Vascular Injury to Extremity
* Ipsilateral femur fractures
* Ipsilateral Hip fractures
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure

This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.

Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing meshes exist.

The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
* 18 years or older
* Patient has a life expectancy of at least 12 months.
* Patient signs the Informed consent and agrees to attend all study visits

Exclusion Criteria:

* Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
* Patients with concurrent or previous malignant tumors within 5 years before study enrollment
* Patients with T4b tumors which imposed a multi-organ resection
* Patient undergone emergency procedures
* Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
* Metastatic disease with life expectancy of less than 12 months
* Pregnancy or suspected pregnancy
Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).


Eligibility Criteria:
Key Inclusion Criteria:

* Must be healthy based on medical history, laboratory work, and physical exam
* Be ≥18 and ≤65 years of age
* Females of childbearing potential must not be pregnant and be using an acceptable form of birth control
* Must be free of any systemic or dermatologic disorder

Key Exclusion Criteria:

* Use of prescription medication within 14 days or over-the-counter products within 7 days prior to study medication
* Current use of opioids
* Known hypersensitivity or allergy to any of the components of the product formulations
* Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization
Vasopressin and V2 Receptor in Meniere's Disease

Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to physical and/or psychogenic stress in their daily life. Meniere's disease is also a common inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized people under stressed life style. Its oto-pathology was firstly revealed in 1938 to be inner ear endolymphatic hydrops through the temporal bone study. To elucidate the neuroscientific relationship between "stress" and "inner ear", we examined plasma vasopressin (the anti-diuretic "stress" hormone) and its receptor, V2R in the endolymphatic sac (the "inner ear" endo-organ for endolymph absorption) in Meniere's patients.

Methods: Between 1998 and 2006, we enrolled and assigned 105 intractable Meniere's patients to examine plasma vasopressin during remission of vertigo attacks (controls: 30 patients with chronic otitis media). Using the real-time PCR method, we examined V2R mRNA expression in the endolymphatic sac in 12 patients (controls: 6 patients with acoustic neurinoma). By means of cell culture and cyclic AMP assay, we also examined cyclic AMP activity in the endolymphatic sac in 3 patients (controls: 3 patients with acoustic neurinoma).

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible for enrollment if they had received a clinical diagnosis of Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These criteria can be briefly described as follows:

  1. Repeated attacks of vertigo: A definitive spell is spontaneous vertigo lasting at least 20 minutes. A mixed type of spontaneous nystagmus is observed during attacks.
  2. Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range.

Exclusion Criteria:

* Any other neuro-otologic diseases.
Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children

Tooth decay is one of the most common chronic infectious disease found in children worldwide and if left untreated, is rapidly progress. Severe tooth decay in children is not only affect child's health and school performance, but also has impact on the family well-being. Oral rehabilitation in children requires time, resources and effort of dental specialists, the child and parents. Caries is a destructive condition of organic and inorganic components of the tooth structures but reversible and most importantly, preventable. Topical fluoride therapy, delivered by dentists has been effectively used to speed up the repair process as well as to strengthen the surface of intact tooth structure. Topical fluoride is available in various preparations. Regular application of sodium fluoride varnish is every three months, by far, considered as effective method in preventing new caries, particularly in the high-risk children. It has the advantage of containing therapeutic concentration of fluoride and ability to flow over and stick to the tooth surface. Whereas silver ion and relatively higher fluoride concentration in Silver Diamine Fluoride (SDF) has been shown to be the most effective in harden the decay, stop the caries progress and eliminate pathogenic bacteria. It can be hypothesize that when use in combination in school children, both reagents might have synergistic effect on arresting existing caries as well as preventing new caries.

Fluoride varnish is a good choice to consider. For caries prevention in young children, It has high efficacy in caries prevention.

Fluoride varnish has a high F concentration and prolong contact time with enamel, So it can prevent new caries and remineralize initial enamel caries. Silver diamine fluoride solution is effective in arresting dentine caries. Silver diamine fluoride has high fluoride concentration and contain silver ion. when apply dentine caries or cavitated caries can increase hardness of dentine and arresting caries.

When use in combination, it might enhance, the Efficacy in Arresting and Preventing Dental Caries in children

Eligibility Criteria:
Inclusion Criteria:

* School children aged 6- 7 years old.
* Have at least one or more active dentin caries lesions in primary canine/molar.
* Parents give consent.

Exclusion Criteria:

* Uncooperative child
* Allergic reaction to silver or materials containing adhesive.
* Received topical fluoride 3 months prior to enrollment.
* Primary carers are unable to response to questionnaire.
Outcomes in CF Patients Accessing Their Registry Health Records

A multifactorial, parallel group, randomised control study in cystic fibrosis (CF) patients aged 13-30 years over an 18 month period. Patients will be offered read-only access to their CF registry electronic health record (CF View), or educational videos on CF (videos), or videos and CF View, or usual standard of care. The study aims are to examine the effect of patient access to C View on a range of clinical outcomes, health service usage, health literacy and patient reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with CF
* registered with their national CF patient registry
* FEV1pp ≥40
* aged 13-30 years

Exclusion Criteria:

* organ transplantation
* FEV1pp \<40
Study of CM310 in Patients With Allergic Rhinitis

This study is a multicenter, single arm, open-label phase II clinical study mainly evaluating the safety of CM310 in patients with allergic rhinitis.

Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-65.
* Understand the study and sign the Informed Consent Form voluntarily.
* Take effective contraception measures throughout the study period.

Exclusion Criteria:

* Used other investigational drugs.
* Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM310.
* Plan to participate in other studies during this clinical trial.
* With malignant or benign tumors of the nasal cavity.
* Other reasons the researcher believes that the subject is not suitable to participate in this study.
Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance

This study aims to examine the effects of cognitive fatigue on heart rate variability and skin conductance and develop a machine learning model.

We hypothesize that increased cognitive fatigue would vary as a function of heart rate variability and skin conductance. A machine learning model will be developed that predicts cognitive fatigue through these physiological responses (Lee et al., 2021). Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, sleep quality, baseline physiology and behavioural performance) will be examined and accounted for.

Eligibility Criteria:
Inclusion Criteria:

* Singapore-based
* Non-clinical
* 18-35years

Exclusion Criteria:

* Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing
* Individuals with a history of ear, developmental, neurological, or psychiatric disorder
Navigation Surgery for Bone and Soft Tissue Tumor

Bone tumor near the articular cartilage is hard to remove sufficiently without damaging adjacent joint. The purpose of this study was to evaluate the feasibility of navigation-assisted surgery for saving joint in bone tumor resection or curettage. In this study, the investigators hypothesized that computer-assisted surgery is feasible method to get both enough margin and joint salvage. Each of them is important intermediate factor for either oncologic outcome or functional outcome respectively. The investigators designed this study to find what proportion of patients who underwent computer-assisted resection could get enough margins using some criteria obtained by overlapping preoperative and postoperative images. The investigators also evaluated whether computer-assisted surgery can be feasible for joint saving using some criteria including functional outcome.


Eligibility Criteria:
Inclusion criteria:

1. First condition is that the benign tumor is located deeply in bones of extremities, or pelvis, so we anticipate the difficulty to find the tumor and to assess the adequacy of resection without the aid of computer-assisted navigation during operation.
2. Second condition is when the violation of joint or growth plate is expected during removal of tumor due to its close proximity to joint or growth plate.

In case of malignant bone tumor, the sufficient preservation of joint anatomy should be required even with resection margin of 1.5 cm away from reactive zone of tumor. The sufficient preservation of joint is defined when at least 1 cm subchondral bone is remained after tumor resection, because 1 cm subchondral bone is required for fixation with allograft in subsequent reconstruction. The sufficient preservation of joint is also defined when articular surface is removed, but more than 50% of articular surface has to be saved.

Exclusion criteria were

1. Patients who denied to perform navigation surgery after explanation of navigation surgery protocol
2. Medically high-risk patients who could not withstand long surgical time for joint reconstruction
3. Patients whose feasibility of joint preservation was not fulfill the above inclusion criteria at initial presentation, although the tumor size was decreased enough to fulfill the inclusion criteria in MRI after completion of neoadjuvant chemotherapy.
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG)

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

Myasthenia gravis (MG) is an autoimmune disease that affects the neuromuscular junction on the postsynaptic membrane. The predominant manifestation is muscle weakness, which typically worsens with repeated muscle exertion, such that function is usually the best in the morning with more pronounced weakness at the end of the day. A major challenge in MG is the lack of therapies that cure the disease.

Telitacicept is a fully human TACI-Fc fusion protein that targets B-lymphocyte stimulator (BLyS) and A proliferating-inducing ligand (APRIL), neutralizing their interactions with receptors on B cells. The blockage of BLyS and APRIL interaction with their respective cell membrane receptors (transmembrane activator and CAML interactor \[TACI\], B-cell maturation antigen, and BLyS receptors) by telitacicept would inhibit B-cell proliferation and maturation. This suppression at the proximal portion of the immune response could alleviate autoimmune symptoms.

This study is a randomized, double-blind, placebo-controlled Phase 3 study with an open-label extension to evaluate the efficacy and safety of telitacicept in a global patient population with gMG.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female patient aged ≥18 years at screening.
2. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV.
3. Patients have positive antibodies against AChR or MuSK at screening.
4. MG-ADL score ≥6 points at screening and baseline with ocular-related score \<50% of the total score.
5. QMG score ≥11 points at screening and baseline.

Key Exclusion Criteria:

1. Patients have been diagnosed with any other autoimmune disease.
2. Patients having acute or chronic infection.
3. Patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening.
4. Patients having current or history of primary immunodeficiency.
5. Patients having history of malignancy within the last 5 years.
6. Patient having prior or continuing diagnosis of serious cardiovascular disease.
Lyme Borreliosis and Early Cutaneous Diagnostic

Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans).

This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).


Eligibility Criteria:
Inclusion Criteria:

* Erythema migrant as criteria EUCALB or atypical form associated to tick's sting
* Patient having signed a consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Prior treatment with antibiotics
* Erythema migrans on the face
* Bleeding disorders
* Anticoagulant treatment
* Inability to give clear information (subject in an emergency situation, understanding of the topic difficulty, ...)
Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery

With 6.5 million obese recorded in France in 2009, obesity is a major public health: it is a chronic disease associated with many respiratory, cardiac, metabolic, musculoskeletal complications. The risk of mortality and morbidity are directly proportional to the importance of overweight and medical treatment alone is only moderately effective weight loss. Bariatric surgery is the only treatment with proven efficacy in patients with a body mass index above 40 kg/m2. As with any surgery, there is a risk of surgical site infection (SSI). The SSI are the third most common nosocomial infection after urinary tract infections and airway. The fight against the ISO requires the administration of antibiotic prophylaxis acting on the main bacteria found in bariatric surgery. There are several studies in the literature interested in the dose of cefazolin in bariatric surgery. However, no published pharmacokinetic studies defines an optimal dose to obtain tissue and plasmatic concentrations of cefazolin higher than minimum inhibitory concentrations of the main germs encountered in these surgery. Only empirical recommendations are published, including the SFAR and the National Institute of Health in 2010. This study aims to determine whether the dose of 4 grams of cefazolin can achieve these goals of concentration and estimate an injection time of preoperative ideal for an adequate tissue concentration at the time of the incision.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged \> 18 years.
* BMI ≥ 40 and ≤ 65 kg/m2.
* The patient has given informed consent in writing.

Exclusion Criteria:

* Age less than 18 years and above 70 years.
* Major Trust.
* Pregnancy.
* Moderate to severe renal insufficiency or clearance creatinine clearance \<60 ml / min
* Hypersensitivity to cephalosporins and beta-lactams.
Effects of Energy Density and Portion Size of Milk in Preschool Children

In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of milk energy density and portion size on preschool children's intake of the milk and the simultaneously served meal. The effect of milk energy density and portion size on children's total energy intake at the meal will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Children must be enrolled in participating childcare centers

Exclusion Criteria:

* Allergy or intolerance to any of the foods or beverages served