cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.

The purpose of this trial is to evaluate the safety and efficacy of once daily orally administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days screening period followed by a 2-week titration period and 12-week maintenance double-blind treatment period and a 10-14 day safety follow up period. Patients who are eligible for the double-blind treatment period will be randomized to one of the following treatment groups: GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Low Back Pain of non-malignant origin and present for at least 3 months.
* Signed informed consent.
* Pain intensity score of 5 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "as bad as you can imagine").
* On stable analgesic medications (non-opioid and/or opioid medications) for chronic low back pain with regular intake for at least 3 months and dissatisfied with current analgesic treatment.

Exclusion Criteria:

* Female subjects who are pregnant or are breastfeeding.
* Presence of risk factors for Torsade de Pointes.
* Any clinically significant disease or laboratory findings that may affect efficacy or safety assessments or may compromise the safety during trial participation, e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, metabolic, neurological, or psychiatric disorders.
* History of acute hepatitis within the past 3 months or chronic hepatitis or a positive result on anti-hepatitis A antibody, hepatitis B surface antigen, or anti-hepatitis C antibody. History of human immunodeficiency virus (HIV) infection.
* History of seizure disorder.
* Chronic low back pain potentially associated with a specific spinal cause.
* Surgery or painful procedure during or within 3 months of enrollment.
* Conditions that contribute and confound the assessment of pain.
* Subjects with impaired renal function.
* Subjects with impaired hepatic functionality.
* Neuromodulation.
* Cancer.
* Clinically relevant history of hypersensitivity, allergy or contraindications to any of the Investigational Medicinal Products' excipients, paracetamol/acetaminophen, tapentadol Hydrochloride, or opioid analgesics (or excipients).
Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to determine whether the investigators can predict which patients are at risk of a re-exacerbation of COPD within 30 and 90 days using changes in lung capacity during the initial exacerbation.

Patients admitted to hospital with an acute exacerbation of COPD will be approached to participate in the study.

The investigators will analyse changes in lung capacity (through measurement of spirometry and inspiratory capacity) and physical activity level over the first three days of admission, at discharge and at a day 30 follow-up visit. The investigators will record quality of life and symptom scores at these time points and again at a day 90 telephone visit. Data relating to the patients overall health status -disease severity, co-morbidity, cognition, psychological status, home environment and adherence to inhaled medication will be collected. The investigators will look for any relationship between these changes and a further exacerbations within 30 and 90 days.

The central hypothesis of this proposal is that the clinical course following an exacerbation of COPD may be monitored through measurement of inspiratory capacity(IC), a marker of lung hyperinflation. Resolution of an exacerbation is related to an increase in inspiratory capacity above a threshold level of improvement, after which the risk of re-exacerbation within the subsequent 30 and 90 days is low. The investigators will assess the accuracy of IC as a predictor of exacerbation and the feasibility of measuring IC during the early stages of a COPD exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* Within 72 hours of admission with an Acute Exacerbation of COPD (AE COPD) defined as "an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy" as per ATS/ERS consensus guidelines\[ \] where "a change in therapy" includes the following: Prescription of antibiotics and / or systemic steroids
* Diagnosis of COPD based on GOLD criteria
* Able to give informed consent
* Willing to participate in the study

Exclusion Criteria:

* Admission reason other than AE COPD or breathlessness primarily caused by another pathology
* Already enrolled in the study
* Receiving palliative care
* Severe cognitive impairment or psychological disorder that results in inability to give informed consent or complete investigations required for the study
* Physical impairment resulting in inability to complete physiological tests
Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia

This is a multicenter retrospective study (Reims and Nancy), with data collection over 12 years from 01/01/2010 to 12/31/2022 Patients included are children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in the 2 centers.

Patients will be categorized into 3 groups:

* No nutritional support
* Support by enteral nutrition
* Parenteral nutrition support Their nutritional status will be assessed at the end of induction, at 6 months and then at 12 months from diagnosis.

The main objective of this study is therefore to compare the nutritional status of children with acute lymphoblastic leukemia depending on whether they received enteral or parenteral nutritional support during their treatment.

The secondary objective is to evaluate the occurrence of complications during treatment according to the nutritional support received.


Eligibility Criteria:
Inclusion Criteria:

* Children between 1 and 18 years old diagnosed with Medium risk/ High Risk B acute lymphoblastic leukemia or Standard/ High Risk T acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims.

Exclusion Criteria:

* Patients less than 1 year old
* leukémia with philadelphia chromosome
* standard risk B acute lymphoblastic leukemia
* bone marrow transplant during treatment
* death during the year following diagnosis
* refusal of the patient (parents) to participate in the study
A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)

This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis

The study consists of a Screening Period (Day -28 to Day -1), a 24-week treatment period (Part A and Part B), a 52 week open label extension and an expected 12-week Follow-up Period. Patients with Relapsing Multiple Sclerosis will be randomized in 2:1 ratio to obexelimab or placebo. Randomization will be stratified by Gd lesion status at screening (≥ 1 vs 0).

Part A is the 12-week Randomized Placebo-Controlled Period (RCP), during which obexelimab or placebo will be administered as weekly subcutaneous (SC) injections. Following Part A, all patients will enter the Part B, a 12-week Open-Label Period (OLP), during which all patients will receive obexelimab administered as weekly SC injections. After Part B, patients will enter Part C, a 52-week Open-Label Extension (OLE), after which they will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part C (i.e. Week 88). If at this time, B cells have not returned to baseline or above the lower limit of normal (LLN), patients will be asked to return every 12 weeks until B cells return to baseline or above the LLN (at minimum). The maximum expected duration of the study is 92 weeks (Screening Period = 4 weeks, Parts A, B and C = 76 weeks, Follow-up Period = 12 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria
2. An EDSS of ≤ 5.5 at the Screening Visit
3. Must have documentation of:

   1. . at least 1 relapse within the previous year OR
   2. . ≥ 2 relapses within the past 2 years OR
   3. . ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening
4. Not of childbearing potential or willing to follow contraceptive guidance

Exclusion Criteria:

1. Primary progressive MS or secondary progressive MS without relapses
2. Meet criteria for neuromyelitis optica spectrum disorder
3. Relapse in the 30 days prior to randomization
4. ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
5. Has \> 20 Gd+ lesions on brain MRI at screening
Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation

The aim of this clinical trial is to prove that acupuncture therapy combined with standard therapy can optimize hemodynamics and reduce pain in post-craniotomy patients with mechanical ventilation. The main questions it aims to answer are:

* Is there a difference in mean arterial pressure, pulse rate, respiratory rate, oxygen fraction and pain in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy and compared to before therapy?
* Is there a difference in changes in ventilator mode in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy?
* Are there any side effects in the acupuncture therapy group combined with standard therapy?

Researchers will compare acupuncture therapy combined with standard therapy to standard therapy only

Participants will:

* receive acupuncture therapy for 3 consecutive days
* outcomes will be assessed after 3 days of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years old
* Subjects who received craniotomy with vascular etiology
* Conscious patients with GCS over 9 before craniotomy
* Using SIMV mode mechanical ventilation
* Family willing for the patient to participate in the study until completion and signed informed consent

Exclusion Criteria:

* History of neuromusculoskeletal diseases such as myasthenia gravis or multiple sclerosis
* Treatment for lung cancer and COVID-19
* There is infection, scarring or malignancy in the acupuncture stabbing area
* Patients with blood clotting disorders, platelets under 50. 000/µl, patients on anticoagulant therapy with INR over 2.0
Efficacy of Local Overpressure Treatment for Meniere's Disease

The purpose of this study to date, is that no causal therapy for Meniere's disease has been discovered. Local overpressure treatment for Meniere's disease is a new treatment form that has been shown in animal and human experiments to reduce the endolymphatic hydrops, a condition that is generally believed to be the pathologic hallmark of Meniere's disease. This study analyzes the efficacy of local overpressure treatment by measuring subjective vertigo severity and objective audiovestibular function parameters.

Randomized double-blind controlled trial. Patients with unilateral Meniere's disease that suffer from recurring vertigo attacks are allocated to either a verum or a placebo device and are treated for 4 months. Before during and after the treatment period, subjective and objective audiovestibular function parameters are measured.

Eligibility Criteria:
Inclusion Criteria:

* unilateral definite Meniere's disease according to the AAO-HNS criteria

Exclusion Criteria:

* previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy
Adipose Cellular Kinetics of Lipedema

Lipedema is characterized by an abnormal deposition of adipose tissue, resulting in fluid accumulation, limb enlargement, and pain. Lipedema is often misdiagnosed as simply obesity. A major challenge with diagnosis is the poorly understood biology underlying the disease. Limited studies suggest that the development of lipedema may involve adipocyte hypertrophy, increased commitment of adipose progenitor cells, hypoxia, adipocyte necrosis and macrophage recruitment. There remains an urgent need to investigate novel characteristics of adipose remodeling that may contribute to the pathogenesis of lipedema. The study investigators have reported quantitative measures of in vivo adipose kinetics using an 8-week incorporation of deuterium (administered as 2H2O) into the adipose tissue of women with obesity. The objective of this proposal is to utilize the metabolic 2H-labeling approach to measure, for the first time, in vivo adipocyte formation and triglyceride synthesis in the adipose tissue of participants with lipedema. Imaging approaches will provide a range of measurements to characterize the lipedema depots. The investigators hypothesize that lipedema adipose depots will have higher rates of adipocyte formation and triglyceride synthesis than both non-lipedema depots and those of women with traditional obesity. Lipedema may involve adipose tissue remodeling, characterized by adipocyte hypertrophy and increased commitment of preadipocytes and differentiation of adipocytes (adipogenesis), yielding an abundance of adipocytes with limited capacity to expand and accommodate lipid, resulting in hypoxia, macrophage recruitment, and local/systemic inflammation. Findings from this proposal will contribute to a better understanding of the pathogenesis of lipedema and may provide insight for the future development of therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≤50 kg/m2
* Waist/hip ratio \<0.86 (standing position)
* Clinical diagnosis of lipedema (mostly Stage 3 but Stage 2 will not be excluded)
* Willing to drink deuterated water (2H2O)

Exclusion Criteria:

* Have major organ disease (heart, kidney, lung, thyroid, liver) or abnormal liver enzymes that represent a problem for study inclusion
* Chronic use of systemic glucocorticoids, atypical anti-psychotic medications, or medications that cause clinically significant changes in weight
* Pregnancy or breastfeeding in the next 3 months
* Partial and/or full hysterectomy (due to estrogen effects on adipogenesis)
* PCOS
* Self-reported positive test for HIV, hepatitis B and hepatitis C
* Smoking or use of tobacco products in the last 6 months
* Any medical, psychiatric or behavioral factors that may interfere with study participation
Foot Plantar Pressure Changes After Plantar Dry Needling

The aim of this clinical trial is to check the effects of dry needling in the Flexor digitorum Brevis.

Twenty healthy subjects wil be recruited for a quasi-experimental study. Participants will be from 18 to 40 years old, not obese. Participants will be measured before and after bilateral dry neddling in Flexor digitorum Brevis. The investigators will measure static footprint variables. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.


Eligibility Criteria:
Inclusion Criteria:

* Flat foot grade II or II with
* Must have latent trigger point in Flexor Brevis Digitorum muscles

Exclusion Criteria:

* Previous lower extremities surgery.
* History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
* Leg-length discrepancy more than 1 cm
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks

This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged ≥ 12 years
* Diagnosed with clinically confirmed C1-INH HAE
* Experienced ≥ 3 HAE attacks during the 3 months before Screening
* Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
* Experienced at least an average of 1 HAE attack per month during the Run-in Period

Exclusion Criteria:

* Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
* Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period
* Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
* Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening
* Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of the last dose of CSL312
* Pregnant, breastfeeding, or not willing to cease breastfeeding
Inpatient Diabetes Mellitus (DM) Management With Continuous Glucose Monitoring Devices, a Pilot Study.

Several observational studies have shown that uncontrolled hyperglycemia in hospitalized patients in the non-critical care, non-Intensive Care Unit (non-ICU) setting is associated with prolonged length of stay, increased mortality and an increased incidence of infections. Randomized clinical trials in both the critical and the non-ICU settings have shown that by improving glucose control there is a decrease in the incidence of infections, length of stay and inpatient health care costs.

Continuous glucose monitoring (CGM) systems have evolved as useful devices providing excellent clinical care in patients with Diabetes Mellitus (DM). These systems detect glucose in subcutaneous interstitial fluid using a glucose sensor that transmits glucose measurements to a receiving device that reads out average glucose levels every couple of minutes.

In this clinical trial the investigators propose to examine the clinical use of CGM in hospitalized patients with Diabetes Mellitus type 2 (DM2). CGM use may improve glucometric values and clinical outcomes in hospitalized individuals with Diabetes Mellitus type 2 (DM2).

We use CGM devices to monitor but also to transmit glucose values wirelessly to monitoring devices that are in the nursing station. Half of the participants are placed on Real Time CGM (alarms turned on) and half of them are placed on blinded CGM values (alarms turned off). Nursing staff will be notified when glucose is \<85 mg/dl , in order to treat and potentially prevent a potential hypoglycemic episode.


Eligibility Criteria:
Inclusion Criteria:

* History of Diabetes Mellitus type 2 (DM2) on insulin

Exclusion Criteria

* Patients that are expected to require a hospital stay ≤3 days
* Pregnant patients
* Subjects that have significant hyperglycemia or Diabetic Ketoacidosis (DKA) that requires treatment with intravenous insulin infusion
* Patients receiving glucocorticosteroids in doses (equivalent) to ≥ 20 mg of hydrocortisone/day
* Any mental condition rendering the subject incapable of understanding the objectives and potential consequences of the study
* Patients that need hospitalization in the critical care (ICU) setting.
* History of Diabetes Mellitus type 1 (DM1)
Effectiveness of Balance Training in Chronic Low Back Pain Patients

Balance problems are addressed in low back pain patients. Dearth of literature available to prove core strengthening or any form of back exercises improving functional outcomes or balance in chronic back pain patients. No studies focus on balance training in improving balance of low back pain patients. The authors are conducting a randomised trial comparing balance exercises and routine back exercise program in improving pain, functional outcomes and balance of the patients

Background: Balance deficits are common in low back pain. Current literature fail to prove the effectiveness of routine back exercises in improving balance of back pain patients. No study has concentrated on balance training in back pain patients.

Objective: Compare balance exercises and routine back exercises in improving balance and other functional outcomes.

Procedure: Back pain patients attending physiotherapy department of tertiary care teaching hospitals will be recruited voluntarily. Randomised to either balance and routine program based on simple lottery method. Balance training comprises of 5 exercises - single leg squats, dead lift, single leg raises, lateral step-ups and forward reach outs. Routine back exercises includes 5 sets - pelvic bridges, dynamic dead bug, prone planks, situps, lateral planks. 10Repetition Maximum, 2 Sets/ day, five days a week, 2 weeks. Baseline balance (star Edward, berg balance) and functional test (sit to stand) and pain (Visual analogue score) and post 2 weeks outcome scores will be analysed through paired and unpaired for between and within groups.

Eligibility Criteria:
Inclusion Criteria:

* non specific low back pain diagnosed by orthopedical surgeon or physiatrist
* Both genders
* Age 25 - 45 years (to avoid age related balance deficit)
* Should have balance deficit percentage (\> 20%) through balance assessment scale

Exclusion Criteria:

* H/O Benign Paroxysmal Positional Vertigo
* Neuromuscular disorders(Stroke, Polio, Potts spine, spinal stenosis) affecting balance
* any form of ear infection
* Recent ear, nose, throat surgery
* Recent surgery in abdomen, thorax, head (\< 2 years)
* Recent lower limb surgeries, injuries (\< 6 months)
* Any form of walking aids (cane, walker)
Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-70 years old;
* Hepatic hemangioma patients who will undergo laparotomy surgery: diameter of hepatic hemangioma between 5-15cm, located in the right liver;
* Child score 5-6;
* BMI: 19-25;
* ASA: Ⅰ \~ Ⅱ grade;
* No comorbidities such as diabetes, hypertension, cardio renal or respiratory dysfunction, mental illness;
* No known allergies;
* No participation in other clinical trials within 2 months;
* Have been informed consent.
* Surgery-related: right subcostal incision, surgical time\< 4 hours, hepatic pedicle occlusion time\< 20 minutes, bleeding\< 1000ml, no blood transfusions.

Exclusion Criteria:

* History of chronic pain，long-term use of analgesic drugs or alcohol abuse;
* Allergic to NSAIDs, opioids or sulfa drugs;
* Coagulopathy or other hematological disorder；
* Active peptic ulcer, gastrointestinal bleeding, inflammatory bowel disease;
* Pregnant or lactating;
* Mentally unstable to use PCA;
* Preoperative pain caused by other disease;
* Analgesic drugs or NSAIDs intake one week before surgery;
* Preoperative systemic inflammatory response syndrome;
* Preoperative chemotherapy or radiotherapy;
* Preoperative or postoperative use of steroids;
* Operative time\> 4 hours, hepatic pedicle occlusion time\> 20 minutes, blood loss\> 1000ml, or intraoperative blood transfusion;
* TBil\> 34 umol/L、PT prolongation\> 3S、ALB\< 30 g/L、or Child score\> 7 within 42 hours after surgery；
* Bleeding、biliary fistula, intra-abdominal infections or other postoperative complications.