cyrilzakka/clinical-trials huggingface dataset:
Pilot of AbStats /AEGIS System for Detecting Motility Abnormalities

When compared to existing analyses: manometry, Smart Pill and lactulose breath testing, external Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) may identify unique audible patterns characteristic of features of gastroinestinal (GI) motility, gastric and small bowel contractions and emptying and small intestinal bacterial overgrowth (SIBO). This research study is designed to test the capabilities of AbStats/AEGIS to identify and associate symptoms and traditional diagnostics with sound readings and correlate this data with treatment outcomes and successes in standard of care.

In partnership with Dr. William Kaiser and the UCLA Wireless Health Institute, our research groups are developing and validating the diagnostic capabilities of device that conducts AEGIS. A belt (AbStats) fits externally around the abdomen and is embedded with acoustic sensors, similar to "electronic stethoscopes." The investigational software is designed to continuously, safely, and comfortably monitor acoustic signals emanating from the esophagus, stomach, and intestines, and stores the data in a HIPAA compliant hard drive. Through the study of associating these readings with current diagnostics and treatments we anticipate that the AEGIS device will eventually provide clinically interpretable information that is immediately actionable. In this study, the Abstats sensor will track signals in tandem with current techniques and standard of care treatments based on those diagnostics. AEGIS analysis could potentially refine, support, or even replace, existing costly and invasive techniques in the diagnosis of gastroparesis, intestinal psueodo-obstruction, colonic inertia, and disorders related to small intestinal bacterial overgrowth (SIBO).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Scheduled for a small bowel manometry, SmartPill, or lactulose hydrogen breath test in the Cedars-Sinai Motility Program

Exclusion Criteria:

* Body mass index that is incompatible with placement of the belt (typically BMI greater than 45)
* Abdominal wall condition that disallows topical coverage as deemed by treating physician (eg abdominal wound, advanced cellulitis, draining ostomy etc)
* Inability to consent
* Have cognitive inability to follow directions
Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

Chronic back and neck pain is the most common chronic condition worldwide. Unfortunately, the current available treatment options are limited and largely unsuccessful, which is considered as one of the primary drivers for the high cost of back pain management. Systematic reviews show that the results of common treatments including pain medications, surgery, exercise and psychological therapies for back pain demonstrate inconsistent results and moderate improvement. Therefore, non-invasive adjunct therapies can be a useful addition to traditional back pain management.

Focused vibroacoustic treatment for back and neck pain is a non-invasive procedure that applies low frequency sound waves to the spine (50Hz-110Hz), and has shown consistent and positive results in early clinical and animal studies. The goal of this project is to test vibroacoustic sound waves delivered to the spine in a double blind randomized controlled trial to demonstrate the efficacy of focused vibroacoustics in treating chronic back pain.

Participants with back pain will be recruited and divided into a treatment and placebo group and will undergo treatment at a clinic over a one month period. Outcome measures will be collected before and after the intervention period. Placebo participants will be offered the full treatment without charge after the experiment is over.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic low back pain with a disease duration of more than 3 months (further diagnostic results were not required)
* Aged 18-75.
* Scored at least 4/10 in pain scale (VAS or Numerical)
* Written consent

Exclusion Criteria:

* Acute back pain (\< 4 weeks)
* History of spinal or vertebral surgery
* History of any vertebral or spinal infection
* History of significant trauma related to the spine
* History of IV drug use
* History of malignancy
* Congenital deformation of the spine (except mild scoliosis or kyphosis)
* Pregnancy
* Previous KKT Treatment
* Undergoing concurrent treatment Unable to complete all 12 treatment sessions due to travel, distance or transportation issues, etc.
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.

The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation.


Eligibility Criteria:
Key Inclusion Criteria:

1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.
2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.
3. Participant achieved CR, or PR suitable for observation at the end of first line therapy based on PET/CT evaluation
4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
5. Adult participants ≥18 years of age.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function
8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.

Key Exclusion Criteria:

1. LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL.
2. Prior treatment with anti-CD19 targeted therapies.
3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
4. Active and clinically significant autoimmune disease.
5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment (e.g., HIV).
6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
Effects of Combined Segmental Vibrator and Neuromuscular Electrical Stimulation in Subacute Stroke

Stroke is leading cause of death and disability worldwide, resulting in significant functional limitations and disabilities experienced by stroke survivors, particularly in the upper limb. There is a need for more effective interventions targeting upper limb sensory motor impairments. The aim of this study is to study combined effect of segmental vibrator and neuromuscular electrical stimulation for flexor and extensor muscle groups on upper limb function in sub-acute stroke.

This study will be a randomized clinical trial and will be conducted in physiotherapy department of Allama Iqbal Memorial Teaching Hospital Sialkot, National Bone and Joint Hospital and Bashir Hospital Sialkot. Forty stroke patients will be recruited through non-probability convenience sampling technique and will be randomly divided in two equal groups Group A and group B through lottery method. Group A will receive high frequency segmental vibration on flexor and extensor muscle groups while group B will receive neuromuscular electrical stimulation along with high frequency segmental vibration(100Hz) on flexor and extensor muscle groups Data will be collected from patients of sub-acute stroke by using screening tool MoCA(for cognition) and assessment tools Fugl-Meyer Assessment Scale(for upper limb function), Wolf Motor Functional Test(for motor function), Modified Ashworth Scale(for spasticity) , Barthel Index(for ADLs), Maximal Hand Grip Strength(for manual dexterity), Maximal Pinch Grip(for manual dexterity), Nottingham Sensory Assessment(for somatosensory function). An informed consent will be taken. Outcome measures will be assessed at baseline, at 4th week and at 8th week. Follow up will be performed at 12th week. Data analysis will be done by SPSS version 28.0.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders
* Aged between 45 and 65 years old
* First ever ischemic stroke experienced more than 3 months before the enrollment
* Spasticity of spastic agonist muscles ranging from 0-2 on the MAS

Exclusion Criteria:

* Patients with bilateral brain lesions
* Ischemic involvement of cerebellum or basal ganglia
* Psychiatric disease and cognitive impairment
* Previous history of other neurological diseases,rheumatic and orthopaedic conditions
* Patients under anti-spastic therapy or other clinical trials
* Metal implants e.g. cardiac pacemakers
Comparison of MAPI+Camrelizumab Versus API+Apatinib Versus MAPI in Patients With a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcoma

Treatment strategies for high-grade osteosarcoma with multidrug chemotherapy and resection result in 3-year event-free survival of 60-70%. The most common factors predicting survival are presence of metastases, histological response to preoperative chemotherapy and complete surgical resection. Four of the active drugs in osteosarcoma include cisplatin, doxorubicin, high-dose methotrexate and ifosfamide and this combination (MAPI), given preoperatively and postoperatively, is widely used for the treatment of osteosarcoma in China. Apatinib also has activity in advanced setting and when incorporated into the treatment of patients with metastatic disease seemed to improve progression-free survival. Combination of apatinib and camrelizumab resulted in durable therapuetic effect in selected cases. Though EURAMOUS-1 suggested that changing chemotherapy postoperatively on the basis of histological response did not improve outcomes. The exploratory study with radomised design to compare combination of chemotherapy with target drug or combination of chemotherapy with anti-PD-1 antibody versus standard chemotherapy has not been tried yet. Thus we aim to investigate the efficacy and toxicity of these combiantions versus standard chemotherapy in this study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed high-grade osteosarcoma, including second malignancies
* Tumor (primary, metastatic, or both) resectable OR is expected to become resectable after neoadjuvant induction chemotherapy
* Suitable for neoadjuvant chemotherapy and adjuvant chemotherapy
* Performance status - Lansky 50-100% (for patients under 16 years of age); Performance status - WHO or ECOG 0-2 with a life expectancy \>3 months
* normal cardiac function (shortening fraction \>28%), normal hearing, normal bone marrow as shown by an absolute neutrophil count of at least 1·5 × 10⁹ cells per L (or a white blood cell count of at least 3 × 10⁹ cells per L if neutrophil count is not available), and a platelet count of at least 100 000 platelets per μL
* Patients were also required to have a serum bilirubin concentration of at most less than 1·5 times the upper limit of normal and a normal creatinine concentration for their age as per protocol
* Women of child-bearing potential had to take adequate contraceptive measures and have a negative pregnancy test within 7 days of study entry.

Exclusion Criteria:

* patients who have recieved anti-angiogenic TKIs or anti-PD-1/PD-L1 antibodies
* allergy to chemotherapy or apatinib or camrelizumab
* other severe illness (eg, psychosis or previous history of cardiovascular disease)
* symptomatic or known CNS metastases
* previous or concurrent second primary malignant tumours
* had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++, and so on
* had other infections or wounds
* pregnant or breastfeeding.
Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines

The purpose of the study is to investigate the safety and duration of effect following different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines (GFL).

This prospective, randomized, double-blind, multi-Center clinical study consists of a two stage experimental main period comparing different dose groups, followed by an optional open-label extension period (20 Units follow-up treatment).

Eligibility Criteria:
Inclusion Criteria:

* Male or female participant 18 years or over.
* Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by investigator on the 4-point facial wrinkle scale (FWS).
* Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant on the 4-point FWS.

Exclusion Criteria:

* Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area within the last 12 months before injection.
* Previous treatment with any facial cosmetic procedure (example, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of eyebrows) in the glabellar area within the last 12 months before injection.
* Previous treatment with any biodegradable filler in the glabellar area within the last 12 months before injection.
* Inability to substantially reduce GFL by physically spreading them apart as assessed by the investigator.
* Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face.
* Any surgery or scars in the glabellar area.
* Marked facial asymmetry.
* Eyelid ptosis.
* Marked brow ptosis and/or dermatochalasis.
* Ongoing severe or unstable medical conditions, example, systemic infection, or pulmonary disease, at the discretion of the investigator.
PIO Laser Sclerectomy IOP SLT Sclerectomy

The main objective of this study is to characterize the changes in IOP over 24 hours after selective trabeculoplasty SLT (before and 1 and 6 months after treatment, decreased IOP, type of rhythm, mesor, acrophase, amplitude). The secondary objective is to evaluate changes in ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after selective laser trabeculoplasty.


Eligibility Criteria:
Inclusion Criteria:

* Primary Open-Angle Glaucoma
* IOP more than 21 mmHg
* Progression under maximal medical therapy
* aged more than 18 years

Exclusion Criteria:

* Pregnant woman
Feasibility and Efficacy of the Ketogenic Diet in Alzheimer's Disease

The purpose of the KDRAFT study is to assess the feasibility and preliminary cognitive efficacy of a ketogenic diet therapy in patients with Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease (CDR 0.5, 1, \& 2)
* Active study partner
* BMI \> 21
* English speaking

Exclusion Criteria:

* BMI \< 21
* Consume greater than 14 drinks of alcohol per week
* Insulin Dependent Diabetes Mellitus
* Diagnosis of active cancer
* Myocardial infarction or symptoms of coronary artery disease (e.g. angina) in last year
Progesterone on the Day of Ovulation Induction is Associated With Pregnancy Outcome

Progesterone levels measured in blood/serum of patients on the day of ovulation induction following controlled ovarian stimulation for in vitro fertilization may be associated with pregnancy outcome. The hypothesis is that higher progesterone levels are associated with lower implantation rates due to changes in the endometrial receptivity.


Eligibility Criteria:
Inclusion Criteria:

* IVF/ICSI following controlled ovarian stimulation
* progesterone measured on the day of ovulation induction
* informed consent

Exclusion Criteria:

* missing consent
Intensive Care Unit Activity in France From the National Database Between 2013 and 2019

Using data from the French National Uniform Hospital Discharge Database (systematically collecting administrative and medical information related to all hospitalized patients in France for care reimbursement purposes), the present study retrospectively assesses the activity of the French Intensive Care Unit (ICU)(1,594,801 ICU admissions):

* In-ICU and in-hospital mortality rates
* Length of stay in ICU and hospital
* Mortality-associated factors during the study period.
* Number of organ failures
* Bed occupancy,
* Regional variations in previous indicators


Eligibility Criteria:
Inclusion Criteria:

All adults patients admitted in French ICU between January 1st, 2013, to December 31st, 2019
Study to Evaluate the Safety/Tolerability, PK and PD After Intravenous DWJ1521 Administration in Healthy Volunteers

A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged ≥ 19 and ≤ 50 years at screening
2. Subjects with a body weight of ≥ 55.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 and ≤ 28.0 at screening

   ☞ BMI(kg/m2) = weight (kg) / {Height (m)}2
3. Subjects who have given written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
4. Subjects eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, investigator questioning, etc.

Exclusion Criteria:

1. Present or prior history of clinically significant hepatic, renal, nervous system, immune, respiratory, and endocrine diseases, hematologic and oncologic diseases, cardiovascular diseases, or mental diseases
2. Gastrointestinal diseases (gastric ulcer, gastritis, gastric cramps, gastroesophageal reflux, Crohn's disease, etc.) that may affect the safety and pharmacokinetic evaluation results of investigational drugs and those with a history of gastrointestinal surgery (except for appendix surgery and hernia surgery alone).
3. Helicobacter pylori positive.
Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow

The aim of this study was to investigate the exploration history, key theories, methods, and techniques involved in the evolution from the intracapsular method to the extracapsular method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety of extracapsular method on the basis of retrospective analysis of 43 cases.

Background: Arthroscopic surgery is widely used in the treatment of refractory tennis elbow due to its advantages of minimally invasive, safe and direct vision. Intra-capsular arthroscopy(intracapsular method), which is performed via natural cavity, is the mainstream arthroscopic procedure. However, intracapsular method requires the damage of joint capsule and may cause intraoperative neurovascular injury and other complications. In view of the defects of intracapsular method, the surgical scheme of the extracapsular arthroscopy (referred to as "extracapsular method") has emerged. The aim of this study was to investigate the exploration history, key theories, methods, and techniques involved in the evolution from the intracapsular method to the extracapsular method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety of extracapsular method.

Methods: Qualitative data were collected via focus group interview. 7 surgeons who were selected through purposive sampling discussed on the theories, methods, and technical specifications of the transition from intracapsular method to extracapsular method. Qualitative data were analysed using NVivo11. Quantitative data of consecutive 43 patients were analysed to evaluate the effectiveness and safety of the extracapsular method. Descriptive analysis was conducted to analyse the demographic characteristics and clinical outcomes after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis was refractory tennis elbow;
2. Standard extracapsular method was used for surgery.

Exclusion Criteria:

1. Patient had past history of joint infection, joint tuberculosis, or osteomyelitis, or the upper limb had undergone surgery within the past 6 months;
2. Diagnosis was combined with severe heart, brain, kidney, or another organ dysfunction;
3. Case was complicated with other serious elbow joint diseases or injuries;
4. Patient did not sign the informed consent form.
Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN

Sub arachnoid hemorrhage consecutive to intracranial aneurysm rupture is a devastating disease. Predictors of intracranial aneurysm rupture are limited and focus mainly on size and location. Platelet activation may have a deleterious role on aneurysm rupture. The assumption is that patients with ruptured intracranial aneurysm will present a higher rate of platelet activation compared to patients with non ruptured aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and over
* Patient presenting a single or multiple aneurysm
* Patient presenting an intracranial aneurysm for which an intervention is planned (endovascular treatment or surgery) : elective intervention for an unruptured aneurysm or emergency surgery for a broken aneurysm

Exclusion Criteria:

- Pregnant or breast feeding woman