cyrilzakka/clinical-trials huggingface dataset:
Effect of Massage Therapy and Occlusal Splint Therapy on the Electromyographic Activity and Mandibular Range of Motion in Individuals With Temporomandibular Disorder

The objectives of this study were to investigate the effects of massage therapy and occlusal splint therapy in the electromyographic activity and mandibular range of motion (ROM) in individuals with temporomandibular disorder (TMD) and compare the results with those obtained in a group of individuals without this disorder. Twenty-eight volunteers with TMD were randomly distributed into two groups, massage therapy and occlusal splint. Both treatments lasted 4 weeks. Fourteen individuals without TMD were consecutively allocated to the control group. The Fonseca's anamnestic index was used to characterize TMD and allocate the volunteers to either the intervention groups or control group. The electromyographic activity and Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way analysis of variance with the Bonferroni test was used for inter and intragroup comparisons (level of significance was set to 5%). Cohen's d was used to calculate the effect size.


Eligibility Criteria:
Inclusion Criteria:

* male and female volunteers
* aged 18 to 40 years

Exclusion Criteria:

* occurrence of missing teeth
* current use of orthodontic appliance
* history of systemic or joint disease
* current use of analgesic, anti-inflammatory agent or muscle relaxant and currently undergoing physical therapy.
Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab

IMC-C103C is an immune mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen MAGE-A4. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-C103C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for MAGE-A4.

The IMC-C103C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases.

1. To identify the maximum tolerated dose (MTD) and/or expansion dose of IMC-C103C as a single agent administered intravenously (IV) and subcutaneously (SC) once weekly (Q1W) and administered Q1W in combination with once every 3 weeks (Q3W) atezolizumab.
2. To assess the preliminary anti-tumor activity of IMC-C103C in one or more selected indications, as a single agent administered Q1W.

Eligibility Criteria:
Inclusion Criteria:

1. HLA-A\*02:01 positive
2. MAGE-A4 positive tumor
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 0 or 1
4. Selected advanced solid tumors
5. Relapsed from, refractory to, or intolerant of standard therapy
6. Measurable disease per RECIST v1.1 (expansion)
7. If applicable, must agree to use highly effective contraception

Exclusion Criteria:

1. Symptomatic or untreated central nervous system metastasis
2. Inadequate washout from prior anticancer therapy
3. Significant ongoing toxicity from prior anticancer treatment
4. Impaired baseline organ function as evaluated by out-of-range laboratory values
5. Clinically significant cardiac disease
6. Active infection requiring systemic antibiotic therapy
7. Known history of human immunodeficiency virus (HIV)
8. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
9. Ongoing treatment with systemic steroids or other immunosuppressive therapies
10. Significant secondary malignancy
11. Pregnancy or lactation
Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder

Relapses in bipolar disorders are associated with a significant proportional functional impact, as well as worsening of the course of bipolar disorder, with impairment of the quality of functional remission, as well as the development of addictive, anxiety and suicidal comorbidities.The functional deficit and the instability of the mood disorder increase with thymic relapses. Currently, these relapses (transition from the state of remission, to a depressive or hyperthymic state) are difficult to predict and to treat because of the absence of correlation between the degree of severity of the stressful event (intensity associated stress) and the occurrence of relapse, taking into account the mediation of this relationship by the stress compensation / adaptation capacities, which are very individual.

This project proposes to develop tools based on artificial intelligence technologies to monitor the level of stress and adaptation to life events as well as identifying relapse predictive factors of a patient by using portable and connected devices recording different physiological signals in order to alert him/her when there is a risk of relapse, thus anticipating therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary subjects responding to the diagnosis of bipolar I or II disorder according to the criteria of the DSM-5
* Agreement to benefit from connected objects required for study and able to understand their use
* Age between 18 and75 years old
* Affiliated to the Social Security system (beneficiary or entitled)
* No opposition signed

Exclusion Criteria:

* Subject included in clinical and/or therapeutic experimentation with exclusion period
* Primary psychiatric pathology other than bipolar type I or II disorder
* Patient hospitalized without consent
* Subject deprived of liberty by judicial or administrative decision
* Pregnant, parturient, breastfeeding woman
* Known allergy to one of the materials of the bracelets
A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent

Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.

Eligibility Criteria:
Inclusion Criteria:

* Adults with 19 years of age or older
* Those who voluntarily consented to the trial and signed a written consent
* Inoperable malignant biliary obstruction

Exclusion Criteria:

* Previous surgical biliary drainage
* Patients continuosly requiring percutaneous transhepatic biliary drainage
* History of biliary drainage with metal stent
* Biliary obstruction located in hilum or intrahepatic duct
* Patients with life expectancy of 3 months or less
* On pregnancy
* Unable to underwent endoscopic procedures
A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors

This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases. The primary objective of Phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors. The primary objective of Phase 2 is to evaluate the efficacy of AB-201.

Subjects will receive up to 3 doses of AB-201, followed by scheduled assessments of overall health and tumor response.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0 to 1.
* Histologically confirmed HER2 expressed breast or gastric/GEJ cancer IHC ≥ 2+ within 6 months prior to study entry.
* Confirmed diagnosis of an advanced/unresectable or metastatic HER2+ breast or gastric/GEJ cancer that is refractory to, or intolerable of standard treatment, or for which no standard treatment is available.
* Must have received prior cancer therapy: Subjects with breast cancer must have received ≥ 2 prior systemic therapies; subjects with gastric/GEJ cancer must have received ≥ 1 prior systemic therapy(ies); subjects with IHC 3+ or IHC 2+/ISH+ cancers must have received previous treatment with a HER2-targeting therapy.

Exclusion Criteria:

* Known past or current malignancy other than inclusion diagnosis.
* Known clinically significant cardiac disease.
* Active central nervous system (CNS) metastases, or involvement of the CNS, unless there is a history of at least 3 months of sustained remission.
* Unresolved toxicities from prior anticancer therapy.
* Ongoing uncontrolled systemic infections requiring antibiotic, anti-fungal, or anti-viral therapy.
* History of sensitivity or intolerance to cyclophosphamide or fludarabine.
* Pregnant or lactating females and subjects of both sexes who are not willing to practice birth control from the time of consent through 6 months after administration of the last AB-201 dose.
* Severe disease progression or health deterioration within 2 weeks prior to lymphodepletion regimen.
Effects of Core Stability Training on the Function and Control of Deep Stabilizing Muscles

This study investigates the effects of core stability training on the functionality and control of deep stabilizing muscles in healthy adults. Core stability exercises focus on strengthening the transversus abdominis and related core muscles to prevent and manage low back pain. Participants are randomly assigned to either the experimental group, performing core stability exercises on unstable surfaces such as a reformer, or the control group, performing aerobic exercises. Outcomes are measured by changes in muscle thickness and contraction time using rehabilitative ultrasound imaging, aiming to demonstrate the potential of core stabilization for enhancing spine support and reducing lower back pain.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 29 years
* Healthy adults who can understand and complete the planned training program
* Individuals who have signed informed consent to participate in the study

Exclusion Criteria:

* Individuals with balance disorders due to orthopedic or neurological conditions
* Those with cardiopulmonary diseases
* Individuals who have undergone surgery within the past 6 months
* Persons with other physical disabilities that could interfere with the study
* Individuals who have participated in similar studies recently
* Pregnant individuals
Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System

The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion using autograft with posterior stabilization.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-cervical spinal stenosis; spondylolisthesis (grade 1 or 2); and/or degenerative disc disease (DDD) with one or two contiguous levels requiring surgical intervention between L1-S1. Qualified patients will be confirmed for inclusion by patient history and radiographic studies
* Willing and able to comply with the requirements of the protocol including follow-up requirements
* Willing and able to sign a study specific informed consent
* Skeletally mature and I 18 years old at time of enrollment

Exclusion Criteria:

* Previous spine surgery at the index level
* Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine
* Active systemic infection or infection at the operative site
* Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
* Metabolic bone disease such as osteoporosis and osteopenia that contradicts spinal surgery
* History of an osteoporotic fracture
* History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
* Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
* Known allergy to titanium or cobalt chrome
* Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C, or fibromyalgia
* Insulin-dependent type 1 or type 2 diabetes
* Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
* Pregnant, or intends to become pregnant, during the course of the study
* Severe obesity (Body Mass Index \> 40)
* Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain, or quality of life.
* Involved in current or pending spinal litigation where permanent disability benefits are being sought
* Incarcerated at the time of study enrollment
* Current participation in an investigational study that may impact study outcomes
Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients

This study provided a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.

This was a randomized, double-blind, placebo-controlled, multicenter design. Patients with moderate to severe plaque psoriasis received secukinumab 300 mg or placebo, with randomization stratified by body weight (\< 90 kg, ≥ 90 kg). There were 5 periods to the study: Screening (1 to 4 weeks), Double-blind Treatment Period (12 weeks), Double-blind Induction Period (4 weeks), Open-label Treatment Period (36 weeks), and Follow-up Period (1 week).

During the Double-blind Treatment Period, all patients attended study visits at Baseline, Weeks 1, 2, 3, 4, 8, and 12, and all doses of study treatment were self-administered at the study site. Patients underwent lesional (LS) and non-lesional (NL) skin biopsies at Baseline and Week 12. Assessments for the primary efficacy variable were performed at Week 12 before patients received their Week 12 dose. During the Double-blind Induction Period, patients randomized to placebo were switched to secukinumab 300 mg for the remainder of the study.

K16 and skin histology/biomarkers were assessed from skin biopsies. The Psoriasis Assessment and Severity Index (PASI) and the Investigator's Global Assessment modified 2011 scale (IGA mod 2011) were performed at specified study visits. Safety was monitored by vital signs, weight, waist circumference, body mass index (BMI), and clinical laboratory tests (serum chemistry, hematology, highsensitivity C-reactive protein (hs-CRP), hemoglobin A1c (HbA1c), homeostatic assessment of insulin resistance (HOMA-IR), viral serology, serum and urine pregnancy).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization
* Moderate to severe plaque psoriasis as defined at baseline by:

  * ≥10% Body Surface Area (BSA) involvement and
  * PASI total score of ≥12 and
  * IGA mod 2011 score of ≥3 (based on a scale of 0-4)

Exclusion Criteria:

* Forms of diagnosed psoriasis other than chronic plaque psoriasis
* Medication-induced or medication exacerbated psoriasis
* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors
* Ongoing use of prohibited treatments
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy

PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone.

This is a single-site prospect triple-blind, randomized controlled trial, that evaluates the efficacy of erector spinae plane (ESP) block with Bupivacaine in reducing pain after medical thoracoscopy (MT). The study aims to compare the effectiveness of ESP block with monitored anesthesia care (MAC) vs MAC alone for patients undergoing MT. Patient will be evaluated post operatively in the post anesthesia care unit and 24 hours after the procedure.

Eligibility Criteria:
Inclusion criteria:

* Referral for medical thoracoscopy
* Age ≥ 18

Exclusion criteria:

* Inability to provide informed consent.
* Study subject has any disease or condition that interferes with safe completion of the study including:

  * Allergic reaction to Bupivacaine.
  * Need for pleurodesis.
  * Allergies to lidocaine or other local anesthetics.
  * Pregnancy.
  * Advanced liver disease where the clinician deems the procedure unsafe.
Evaluation of Remnant Cholesterol Levels and Monocyte-to-HDL-cholesterol Ratio As Predictors of Coronary Artery Disease Severity in Patients with Acute Coronary Syndrome

1. Evaluation of serum level of remnant cholesterol and monocyte/HDL ratio as predictors of severity of coronary artery disease in patients with acute coronary syndrome.
2. Evaluate predictive value of remnant cholesterol serum level and monocyte/HDL ratio to detect in-hospital worse clinical outcomes and 45 days major adverse cardiac events (MACE) after acute coronary syndrome.

Acute coronary syndrome (ACS) refers to a group of conditions that include ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina. It is a type of coronary heart disease (CHD), ACS is the most common cause of death in patients with CAD and it is estimated that about 661,000 people in the United States suffer from ACS in 2016 ,which highlights the importance of risk assessment for ACS.

Elevated remnant cholesterol, including cholesterol carried in VLDL and chylomicron remnants, is emerging as a causal risk factor for ASCV in addition to elevated LDL-cholesterol ,Studies of the general population have shown that risk of myocardial infarction, ischemic stroke and peripheral artery disease is increased in individuals with elevated remnant cholesterol. High-density lipoprotein-cholesterol (HDL-C) exhibits anti-atherosclerotic effects by neutralizing the pro-inflammatory and pro-oxidant effects of monocytes via inhibiting the migration of macrophages and LDL oxidation in addition to the efflux of cholesterol from these cells. Furthermore, HDL plays a role in suppressing the activation of monocytes and proliferation-differentiation of monocyte progenitor cells. Thus, accumulation of monocytes and reduction of HDL-C may participate in atherosclerosis and cardiovascular diseases (CVD) .

Global Registry of Acute Coronary Events (GRACE) score is a risk assessment system for ACS based on risk factors summarized from clinical cases.

The Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score is a scoring system for risk stratification based on the anatomical characteristics of coronary artery lesions to help cardiologists, interventionists and surgeons to grade the complexity of coronary artery lesions .

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute coronary syndrome presented to ER of Assiut university hospital scheduled for primary PCI and able to provide informed consent.

Exclusion Criteria:

* Patients on previous statin therapy.
* Patients with severe renal dysfunction (creatinine clearance \<30 mL/min) or other contraindications to PCI.
* Patients with missed data or who couldn't be followed up
JAVLOR® Online Non-Interventional Trial

Documentation of data concerning tolerability and efficacy of the intravenous treatment with vinflunine performed under daily routine conditions in Germany. The trial focusses on tolerability including the assessment of the usage of anti-emetic and anti-obstipative concomitant treatment as well as on the efficacy of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Legally competent male and female patients
* Advanced or metastatic transitional cell carcinoma of the urothelium
* Failure of a prior Cisplatinum-containing treatment
* Performance Status 0 or 1
* Signed patient informed consent

Exclusion Criteria:

* Missing signed patient informed consent
* Performance Status 2 or higher
* Life expectancy \< 2 months
* Brain metastases
* Creatinine-clearance \< 20 ml/min
* Child-Pugh-stadium C
* Prothrombin time \< 50%
* Bilirubin \> 5 x ULN
* Transaminases \> 6 x ULN
* Gamma-Glutamyl-transferase \> 15 x ULN
* Pregnant or breast-feeding women
* Known/suspected hypersensitivity against vinflunine or other vinca-alkaloids
* Recent (within the last 2 weeks) or current severe infections
* Baseline ANC \< 1,500/mm3 or platelets \< 100,000/mm3
* Patients being institutionalised due to court/regulatory order
Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas

GMX1777 is a water-soluble, intravenously-administered prodrug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.

This is a single-center, open-label, Phase I study of single-agent GMX1777 administered every 3 weeks to patients with CLL, MM, refractory solid tumors or lymphomas. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically or cytologically confirmed solid tumor or lymphoma
* No limitations on allowable type and amount of prior therapy.
* Patients must have a life expectancy of greater than 8 weeks
* Patients must have normal organ and marrow function
* Patients must be willing to submit blood sampling for planned PK analysis
* Patients must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

* No other agents or therapies administered with the intent to treat malignancy
* Patients with prior exposure to GMX1777 or GMX1778
* Uncontrolled, intercurrent illness
* Pregnant women and women who are breast feeding