cyrilzakka/clinical-trials huggingface dataset:
The Effect Thoracolumbar Fascia on the Abdominal Muscle

The aim of this study was to evaluate the changes in the thickness of abdominal muscles during activation of thoracolumbar fascia through contracting the gluteus maximus and latissimus dorsi muscles. The hypothesis was that the thickness of transversus abdominis and internal oblique would show greater increase when abdominal contraction was performed with simultaneous contraction of gluteus maximus and latissimus dorsi (bridge with arm extension) than that of abdominal contraction alone (abdominal hollowing) or abdominal contraction with simultaneous activation of only gluteus maximus (bridge). Thirty healthy subjects (15 women, 15 men) were enrolled in this cross-sectional study. Thickness of transversus abdominis, internal oblique and external oblique muscles were evaluated using ultrasound at rest and during three exercise positions: abdominal hollowing in neutral spine, bridge, and bridge with isometric arm extension using ultrasound device equipped with 55 mm convex array transducer

Spinal stabilization is crucial in maintaining healthy posture. Core muscle activation could be enhanced using thoracolumbar fascia for this stability.

Core, also called 'power house', is a muscular box built from abdominal muscles in the front, paraspinal, and gluteal muscles at the back, diaphragm at the top, and pelvic floor muscles at the bottom. Deep core muscles control intersegmental motion and respond to postural and extrinsic load changes and consist of transversus abdominis, internal oblique, multifidi and pelvic floor muscles.

Myofascial system links latissimus dorsi and gluteus maximus through thoracolumbar fascia causing tensegrity-like network in the whole body.

The aim of this study was to evaluate the changes in the thickness of abdominal muscles during activation of thoracolumbar fascia through contracting the gluteus maximus and latissimus dorsi muscles. The hypothesis was that the thickness of transversus abdominis and internal oblique would show greater increase when abdominal contraction was performed with simultaneous contraction of gluteus maximus and latissimus dorsi (bridge with arm extension) than that of abdominal contraction alone (abdominal hollowing) or abdominal contraction with simultaneous activation of only gluteus maximus (bridge).

Thirty healthy subjects (15 women, 15 men) were enrolled in this cross-sectional study. Thickness of transversus abdominis, internal oblique and external oblique muscles were evaluated using ultrasound at rest and during three exercise positions: abdominal hollowing in neutral spine, bridge, and bridge with isometric arm extension using ultrasound device equipped with 55 mm convex array transducer.

Eligibility Criteria:
age of \>18 years absence of back or abdominal problems.
The REgistry of Very Early Estrogen and AnovuLation

The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition.


Eligibility Criteria:
Inclusion Criteria:

* 3 or more months of consecutive amenorrhea with a diagnosis of functional hypothalamic amenorrhea or screening hormones consistent with functional hypothalamic amenorrhea including but not limited to:

  * Estradiol: \< 50pg/mL
  * LH: \< 10 IU/mL
  * FSH: \< 10 IU
  * Testosterone: 2 - 45 ng/dL
  * Free Testosterone: 0.1 - 6.4 pg/mL
  * FT4: 0.93 - 1.70 ng/dL
  * Prolactin: \< 20 ng/mL
  * AMH: \> 1 ng/mL
  * Urine or serum human chorionic gonadotropin: Negative
* LH:FSH Ratio \<1
* No signs of male-like hair growth on the upper lip, chin, chest, abdomen, buttocks, or back
* Does not have a diagnosis for secondary amenorrhea, including prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction
* Premenopausal status determined by WISE criteria
* Able to give informed consent
* Able to read English

Exclusion Criteria:

* Parturition/lactating in the last 6-12 months
* Lack of consent
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma

This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.

This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment.

R/R MCL patients will be enrolled in dose level of 1.0 x 10\^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old;
* Sign on the informed consent;
* Subject must have histologically confirmed mantle cell lymphoma;
* Relapsed/refractory patients;
* Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Expected survival is greater than 12 weeks;
* Adequate organ function;
* Adequate vascular access for leukapheresis procedure;
* Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
* Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
* Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029.

Exclusion Criteria:

* Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma;
* History of another primary malignancy that has not been in remission for at least 2 years;
* Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
* Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
* Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
* Presence of acute or chronic graft-versus-host disease (GVHD);
* History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
* Pregnant or nursing women;
* Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
* Received allo-hematopoietic stem cell transplantation therapy previously.
* Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
* Received CAR T-cell or other genetically-modified T-cell therapy previously.
High Order Spectral Analysis of Local Field Potential Data on a Subgroup of Parkinson's Disease Patients Who Are Carriers of Mutations in the Glucocerebrosidase (GBA) Gene Undergoing DBS Electrode Placement

The aim is to study a specific group of PD patients, carriers of mutations in the glucocerebrosidase (GBA) gene, which is the most common genetic risk factor for PD and is a harbinger of aggressive cognitive and motor decline. Approximately 12-17% of PD patients undergoing DBS are GBA mutation carriers. GBA mutation carriers with PD have a specific phenotype characterized by more significant motor dysfunction and reduced short-term visual memory function compared with their non-GBA counterparts. Thus as GBA mutation carriers have a "signature" phenotype, the investigators hypothesize that these GBA mutation carriers have a unique "signature" of oscillatory activity that can be distinguished from non-mutation carriers during motor activation and during cognitive tasks. Identification of this "signature" will provide critical information that is required to: 1) understand the underlying neurophysiological mechanisms responsible for the aggressive disease course of GBA associated PD, and 2) further develop customized adaptive DBS systems.


Eligibility Criteria:
Inclusion Criteria:

* undergoing bilateral STN-DBS
* diagnosis of Parkinson's disease

Exclusion Criteria:

* no Parkinson's disease
Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis

The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months
2. Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg\~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit

Exclusion Criteria:

1. History of following diseases

   * Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment
   * Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.）
   * Severe infectious disease（hepatitis, pneumonia、sepsis）
   * History of demyelinating disease or multiple sclerosis
   * Congestive heart failure
   * lymphoproliferative disorder or myelodysplastic syndrome
   * History of malignancy
   * Interstitial lung disease
2. Patients with active or latent tuberculosis or history of tuberculosis
Patient-based Care Versus Standard Care for Patients With hEDS/HSD and Multidirectional Shoulder Instability

For hEDS or HSD patients with MDI, a multidisciplinary treatment approach is suggested. As follows, physiotherapy plays a key role in this integrative management. Nevertheless, knowledge regarding EDS is limited among health care professionals. Consequently, evidence-based treatment approaches for the hEDS/HSD population are scarce. Therefore, the aim of this study is to compare two different home-based exercise programs in order to increase our knowledge regarding treatment options, and to gain insight in safe, effective exercises for the unstable shoulder in this study population.

The main purpose of this study was to evaluate the value of two telerehabilitation exercise programs for treating multidirectional shoulder instability (MDI) in patients diagnosed with the hypermobile type of The Ehlers-Danlos syndrome (hEDS) or Hypermobility Spectrum Disorders (HSD). Patients were randomly assigned to either the control group (B: evidence-based tailored care) or the experimental group (A: evidence-based standard care). Both groups received a home-based exercise program of 24 weeks. The primary outcome measure was the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH), Tampa Scale for Kinesiophobia (TSK), Patient-Specific Functional Scale (PSFS), Global Rating of Change (GROC), and pain pressure thresholds (PPTs). Outcomes were assessed at baseline, after 6 weeks, 12 weeks, and at the end of the study (24 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-65 years
* Patients diagnosed by a medical doctor with generalized HSD or hEDS, according to the diagnostic criteria for hEDS and HSD as stated in the recently published international classification for the Ehlers-Danlos syndromes
* Patients diagnosed with multidirctional shoulder instability (MDI): The diagnosis of MDI was confirmed when 1) patients reported symptoms of shoulder instability in daily life (e.g. recurrent subluxations) without a traumatic onset; 2) patients scored positive on shoulder laxity and instability tests (i.e. sulcus sign, anterior and posterior load and shift, posterior jerk, Gagey hyperabduction test, passive and active external rotation in supine, apprehension and relocation test) in at least two directions; 3) patients had shoulder pain for at least three months prior to the study.

Exclusion Criteria:

* pregnancy during study participation
* patients who started a new physiotherapeutic treatment in the 2 weeks prior to the study
Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

The long-term goal is to transform the diagnosis and treatment of dysphonia by elucidating cervical and cranial neuromuscular mechanisms underlying typical and disordered voicing. The overall objective of this application is to propose and evaluate a novel objective spectrotemporal diagnostic tool measuring functional cervical-cranial muscle network activity in typical and disordered speakers.The purpose of this study is to improve our understanding of how the vocal tract and the muscles of the larynx and the head work at baseline and after vocal fatigue.

Three experiments will be conducted over the 2-year award period. Experiment 1 (Aim 1) will utilize a 16-channel EMG array to characterize cervical-cranial muscle activity networks in typical speakers at baseline and after a vocal loading task. Aim 2 will quantify how cervical muscle networks are perturbed in patients with two different types of dysphonia and examine if standard-of-care treatment restores cervical-cranial muscle networks to more typical states. In Experiment 2 (Aim 2), we will measure muscle networks in patients with muscle tension dysphonia before and after a course of voice therapy. Patients with muscle tension dysphonia represent an intact butpotentially maladaptive network. In Experiment 3 (Aim 2), we will measure patients with unilateral vocal fold paralysis, representing a neurologically impaired network, before and after a vocal fold injection medialization procedure.

Eligibility Criteria:
Inclusion Criteria:

Experimental Group

* Age \>18 years;
* Patient cohorts diagnosed with muscle tension dysphonia with a recommended treatment of voice therapy.
* Patient cohorts diagnosed with unilateral vocal cord paralysis with a recommended treatment of vocal fold injection medialization.
* Willingness to complete all clinical/research assessments
* Ability to give informed consent

(Control Group)

* Age \>18 years;
* Absence of any organic vocal lesion as determined on flexible laryngoscopy.
* Willingness to complete all clinical/research assessments
* Ability to give informed consent

Exclusion Criteria:

Experimental Group:

* Any contraindication for wearing the device, such as a known or reported (at any time including during the study):
* allergy;
* history of head and neck surgery in the past 3 months;
* presence of open wound or/and ulcer in close proximity to sEMG sensors;
* 'smart' implant with a microcontroller (such as a pain pump or nerve stimulator);
* participation in additional clinical research studies using investigational treatments.

Control group:

* Any contraindication for wearing the device, such as a known or reported (at any time including during the study) allergy;
* Abnormal laryngeal structure and function as determined via laryngeal endoscopic exam;
* History of head and neck surgery in the past 3 months;
* Presence of open wound or/and ulcer in close proximity to sEMG sensors;
* 'Smart' implant with a microcontroller (such as a pain pump or nerve stimulator);
* Participation in additional clinical research studies using investigational treatments.
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)

Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) and who completed the follow-up in the P02538 Part 1 study (NCT00104052). No study drug therapy will be administered during the P02538 Part 2 study. Durability of virologic response will be assessed for participants who attained sustained virologic response (SVR) in Part I of this study by performing annual Hepatitis C Virus ribonucleic acid (HCV-RNA) testing. In addition, this study will characterize long-term safety in all participants who received PEG-IFN plus RBV treatment.

During the Part 2 LTFU, participants will be evaluated at Years 1, 2, 3, 4, and 5. Each participant's first LTFU visit will be scheduled approximately 1 year after the post-treatment Follow-up Week 24 visit in Part 1 of this study (NCT00104052).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent must be obtained from the participant or the participant's parent or legal guardian prior to any long-term follow-up study-related procedures. According to local laws and/or IRB/IEC requirements, participants may also need to provide written assent.
* The participant must have received at least one dose of peginterferon alfa-2b and ribavirin in the Protocol No. P02538 study.
* The participant must have completed the 24-week post-treatment follow-up in the P02538 Part 1 study. All participants whether sustained responders, relapsers, or nonresponders are eligible to participate.

Exclusion Criteria:

* Concurrent participation in any other clinical study.
* Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuation from, the treatment phase of the P02538 Part 1 study.
* Any condition that in the opinion of the Investigator would make the participant unsuitable for enrollment.
LOWER: Lomitapide Observational Worldwide Evaluation Registry

This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.

To evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.

Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages, including minors, who have initiated commercial treatment with lomitapide prior to or at time of registry enrolment.
* Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures or paediatric patients with the consent of a parent or legal guardian.

Patients ≥7 years of age (or above the age determined by the IRB/EC and in accordance with the local regulations and requirements) must also provide written informed assent forms.

Exclusion Criteria:

* Patients who are receiving lomitapide in clinical trials or through compassionate use, where patients are followed under a separate protocol.
* Patients receiving an investigational agent, defined as any drug or biologic agent other than lomitapide that has not received market authorization in the country of participation, at time of lomitapide initiation and continuing to receive an investigational agent at time of registry enrolment. These patients may be enrolled if receiving lomitapide when the investigational agent is discontinued..
Candesartan Cilexetil/Amlodipine Besilate Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"

The purpose of this survey is to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) low dose (LD), high dose (HD) in participants with hypertension in the normal clinical setting.

This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) in participants with hypertension in the routine clinical setting.

The usual adult dosage is one tablet (8 mg/2.5 mg or 8 mg/5 mg as candesartan cilexetil/amlodipine besilate) administered orally once daily.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with hypertension

Exclusion Criteria:

1. Participants in whom Candesartan cilexetil/Amlodipine besilate is contraindicated \[Contraindications\]
2. Participants with a history of hypersensitivity to the ingredients of Candesartan cilexetil/Amlodipine besilate or any other dihydropyridine formulations
3. Women who are pregnant or of child-bearing potential
Dual Thrombolytic Therapy With Mutant Pro-urokinase and Low Dose Alteplase for Ischemic Stroke

Randomized controlled phase II trial to test the safety and preliminary efficacy of a dual thrombolytic treatment consisting of a small intravenous (IV) bolus of alteplase followed by IV infusion of mutant pro-urokinase against usual treatment with IV alteplase in patients presenting with ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of ischemic stroke;
* A score of at least 1 on the NIH Stroke Scale;
* CT ruling out intracranial hemorrhage;
* Treatment possible within 4.5 hours from symptom onset or last seen well;
* Meet the criteria for standard treatment for IV alteplase according to national guidelines27;
* Age of 18 years or older;
* Written informed consent (deferred).

Exclusion Criteria:

* Candidate for endovascular thrombectomy (i.e., a proximal intracranial large artery occlusion on CTA);
* Contra-indication for treatment with IV alteplase according to national guidelines27:

  * Arterial blood pressure exceeding 185/110 mmHg and not responding to treatment
  * Blood glucose less than 2.7 or over 22.2 mmol/L
  * Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
  * Head trauma in the previous 4 weeks
  * Major surgery or serious trauma in the previous 2 weeks
  * Gastrointestinal or urinary tract hemorrhage in the previous 2 weeks
  * Previous intracerebral hemorrhage
  * Use of anticoagulant with INR exceeding 1.7 or APTT exceeding 50 seconds
  * Known thrombocyte count less than 90 x 109 /L
  * Treatment with direct thrombin or factor X inhibitors, unless specific antidotum has been given, i.e. idarucizumab in case of dabigatran use.
* Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS \> 2;
* Known pregnancy or if pregnancy cannot be excluded, i.e. did not have intercourse for \> 6 months and no clinical signs of pregnancy, adequate use of any contraceptive method (e.g. intrauterine devices) or sterilization of the subject herself.
* Contra-indication for an MRI scan, i.e.:

  * an MRI incompatible pacemaker, ICD, pacing wires and loop records
  * metallic foreign bodies (e.g. intra-ocular)
  * prosthetic heart valves
  * blood vessel clips, coils or stents
  * an implanted electronic and/or magnetic implant or pump (e.g. neurostimulator)
  * cochlear implants
  * mechanical implants (implanted less than 6 weeks ago)
  * a copper intrauterine device
* Current Participation in any medical or surgical therapeutic trial other than DUMAS.