cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"

Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer


Eligibility Criteria:
Inclusion Criteria:

* First intention of the rotator cuff
* Repairable supraspinatus and infraspinatus type 2 rupture (according to the PATTE classification, tendon retraction at the top of the humeral head)
* No surgical history
* Patient who has given his participation agreement to participate in the observational study after information by the surgeon,
* Patient living in France and having the capacity to answer alone to the survey.
* Subject affiliated to a social security scheme
* Lack of participation in another clinical study

Exclusion Criteria:

* Major subject protected by law, under curatorship or tutorship
* Known allergy to Inspace medical device materials (PLA and -θ-caprolactone copolymer)
* Osteoporosis
* Damaged cartilage
* Isolated rupture of the suprascapularis
* Glenohumeral instability
* Pseudo-paralytic shoulder- Infection
* Necrosis
* Major joint trauma
* Pregnant or breastfeeding women
Clinical Performance of AFGen1

AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of AFGen1 on human participants.

The primary purpose of this study is to demonstrate the ECG signal acquired by the AFGen1 device is of adequate quality and is suitable to support its intended use for the detection of Afib. This will be evaluated by comparing the ECG data acquired by AFGen1 to that acquired by an FDA cleared 12-lead ECG device. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires over the maximum 7-day wear period that it can be prescribed for use.

The secondary purpose of this study is to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ANSI AAMI EC12-1 .

Eligibility Criteria:
Inclusion Criteria:

1. 18+ willing to sign the consent form

Exclusion Criteria:

1. Implanted pacemakers
2. Implanted cardioverter defibrillators
3. Implanted cardiac resynchronization devices
4. Potential life-threatening arrythmias
5. Physical or mental health conditions that would prevent the person from being able to follow instructions regarding participation in the study
6. Open wounds, abraded or irritated skin at the application site
7. Planned to undergo a MRI during the course of the study duration
8. Known or suspected to be pregnant
9. Student or employee of TriVirum
Visibility - Classification of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks

We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.

We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.

VIS(visibility) 1 easy identification and instant visualisation of all structures VIS 2 identification and visualisation of all structures after some corrections VIS 3 identification and visualisation of structures only unsure VIS 4 identification and visualisation of all structures impossible VIS 5 no structures seen. We amended a sub-project in which assessed the visibility in protective nerve stimulated nerve blocks in 46 patients.

Eligibility Criteria:
Inclusion Criteria (study sample N=1200):

* peripheral nerve block by ultrasound guidance
* age ≥ 18 years

Exclusion Criteria:

* contraindications for regional anesthesia

Inclusion Criteria (study sample as of amendment n=46):

* peripheral nerve block by ultrasound guidance
* age ≥ 18 years

Exclusion Criteria:

* contraindications for regional anesthesia (study sample n=46)
* using not the standard ultrasound machine
* performing not a standard regional anesthesia
Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients

The purpose of this study is to determine whether either a peripheral nerve block under ultrasound (u/s) guidance of the lateral femoral cutaneous nerve (LFCN), versus an u/s guided block of the nerve followed by continuous catheter infusion of local anesthetic, offers better post-operative analgesia in pediatric burn patients undergoing reconstructive surgery, than the current analgesic regimen of subcutaneous local anesthetic infiltration.

Eligible subject, pediatric patients having reconstructive surgery for burns, having skin graft donor sites of the lateral thighs, will be randomized into three groups: control (having local infiltration of site), ultrasound guided nerve block, or ultrasound guided nerve block with catheter placement --fascia iliac.

Post-operative comfort will be assessed over the next 48 hours.


Eligibility Criteria:
Inclusion Criteria:

* going for reconstructive surgery requiring split thickness skin graft
* patient's donor site will be in distribution of lateral femoral cutaneous nerve
* age \>=2 and \<22
* patient emotionally/intellectually able to describe intensity of post-op pain using VAS or Wong- Baker faces scale.

Exclusion Criteria:

* potential block/catheter site infected or burned.
* intolerance/allergy to local anesthetics
* BMI \> 30
* American Society of Anesthesiologists (ASA) score \> 2
Assessing the Impact of Pioglitazone on Skin Barrier Function in Atopic Dermatitis Patients

Many patients with eczema (atopic dermatitis) have an inherent defect in their skin barrier as demonstrated by high water loss. In laboratory conditions, studies have shown that pioglitazone restores the skin barrier function in skin from eczema patients. The purpose of this study is to determine if taking pioglitazone improves the skin barrier function in people with eczema.

Enrolled patients will be randomized to either placebo or pioglitazone. Each randomized subject will have a skin biopsy and skin irritancy assay performed prior to treatment and at the end of 12 weeks of treatment. Noninvasive barrier measurements including transepidermal water loss will be recorded at all study visits.

Eligibility Criteria:
Inclusion Criteria:

* i. Moderate to Severe AD: EASI ≥ 10 ii. Active Atopic Dermatitis: Subjects must have within the last 3 months according to medical records or by medical exam of the investigator:

  * Pruritus
  * Eczema (acute, subacute, chronic)

I. Typical morphology and age-specific patterns - Patterns include (1) facial, neck, and extensor involvement in infants and children, (2) current or prior flexural lesions in any age group, (3) sparing groin and axillary regions.

II. Chronic or relapsing history

iii. Extrinsic they must also meet both of the following: serum total IgE ≥ 1.5 S.D. greater than the age-matched norms and positive multi-allergen RAST (Phadiatop).

Additionally, subjects must have TEWL of nonlesional skin of upper arm that is ≥ 8 gm/m2/h at screening visit. This is to ensure that we are in fact studying the subset of AD subjects who have a skin barrier defect.

Exclusion Criteria:

* Unwillingness or inability to complete the Informed Consent process
* Subjects with a history of keloid formation
* History of lidocaine or Novocain allergy
* Subjects with a systemic infection requiring a course of systemic antibiotics or antivirals within the last 2 weeks
* Subjects with MD diagnosed Type 1 or 2 diabetes mellitus
* Subjects with NYHA class III or IV cardiac status
* Subjects with a history of liver disease (EtOH, viral hepatitis, drug-induced hepatitis or other)
* Subjects with evidence of an underlying systemic disease based on history and physical (other than the above diagnostic categories (and associated allergic disorders), or well-controlled hypertension, or hyperlipidemia).
* History of cancer other than nonmelanomatous skin cancer or cervical dysplasia
* Participants enrolled while on a systemic treatment for their atopic dermatitis (e.g. cyclosporine, mycophenolate mofetil) must remain on a stable dose for the duration of the study
Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of transplant-related complications in eligible alloHCT patients


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years old
* Presence of a hematologic malignancy for which an alloHCT is indicated with a reduced toxicity or reduced intensity conditioning regimen
* Patients with polynuclear neutrophils \> 0.5 G/L
* Patients having received wide spectrum antibiotics within the last 90 days prior to inclusion
* Karnofsky index ≥ 70%
* Availability of a sibling donor, an unrelated stem-cell donor or a familial haploidentical donor
* Written informed consent

Exclusion Criteria:

* Patients planned to receive a non-myeloablative conditioning regimen (2 Gray total body irradiation (TBI) +/- purine analog, fludarabine + cyclophosphamide or equivalent)
* Patients planned to receive a conventional myeloablative conditioning regimen (e.g. high dose cyclophosphamide and high dose TBI (≥10Gy); high dose busulfan (12.8 mg/kg IV) + high dose cyclophosphamide)
* Patients receiving a manipulated graft (in-vitro T-cell depletion)
* Patients planned to receive a conditioning regimen with alemtuzumab
* Patients planned to receive alloHCT with cord blood cells
* Patients planned to receive alloHCT from unrelated donor with \>= 3/10 HLA-mismatches
* Patients receiving a large spectrum antibiotic at time of randomization
* Patients planned to receive vedolizumab or abatacept for GvHD prophylaxis
* Creatinine clearance \<30 mL/min
* Bilirubin or amino-transferases abnormalities contra-indicating alloHCT
* Cardiac ejection fraction less than 40%
* Pulmonary impairment with \<50% lung carbon monoxide diffusing capacity (DLCO)
* Pregnancy
* Confirmed or suspected intestinal ischemia
* Confirmed or suspected toxic megacolon or gastrointestinal perforation
* Any history of gastro-intestinal surgery in the past 3 months
* Any history of chronic digestive disease (Crohn's disease, ulcerative colitis, inflammatory bowel disease or other relevant digestive condition according to physician's judgement)
* Known allergy or intolerance to trehalose or maltodextrin
* Patients with EBV-IgG negative serology
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
* Vulnerable patients such as: persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.
Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients

Regorafenib is currently the standard of care for refractory mCRC patients. Pivotal studies of regorafenib have proven the efficacy and safety, with a 28-day cycle (21 days on, 7 days off) and 160 mg dose given once daily.

In the clinic, patients often have some complicated condition. This study aims to perform retrospective medical chart review of mCRC patients who received regorafenib treatment in two medical centers in Taiwan to examine treatment effectiveness in the routine clinical practice setting.


Eligibility Criteria:
Inclusion Criteria:

* mCRC patients who received at least one dose of regorafenib treatment

Exclusion Criteria:

* \<=20 y/o
* Patients who did not receive regorafenib treatment will be excluded from the analysis
* Patients with incomplete medical records that are deemed ineligible for analysis by investigator
R3® Acetabular System in Patients With Degenerative Hip Disease

This is a prospective, non-randomized, consecutive series, multicenter clinical study that will include patients who will have total hip replacement with the R3 Acetabular System.

The study design was selected to assess the safety and effectiveness profile of the R3 Acetabular System in patients with degenerative joint disease requiring primary total hip replacement. A non¬-randomized, consecutive series of up to 158 patients will be enrolled, and a maximum of 8 sites will participate in the study. Each site is allowed to enroll up to 22 patients. When 158 patients are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. The clinical data from this study will be compared with a historical control. The study will include follow up through 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient is of legal age to consent and skeletally mature.
* Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia/DDH)
* Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk.
* The patient will be available for follow-up throughout the duration of the study.

Exclusion Criteria:

* Patient has active infection or sepsis (treated or untreated)
* Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
* Patient is pregnant or plans to become pregnant during the course of the study Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
* Patient has inflammatory joint disease (e.g. rheumatoid arthritis)
* Patient has known moderate to severe renal insufficiency.
* Patient has a known or suspected metal sensitivity.
* Patient is immunosuppressed or receiving high doses of corticosteroids.
* Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
* Patient has BMI \>40.
* Patient is a prisoner
The Effect of Alginate Encapsulated Supplements on Athletic Performance and Recovery

Endurance sport is often characterized by high training loads and significant metabolic demands, including depletion of endogenous fuel stores (e.g. liver and muscle glycogen) and damage to the skeletal muscle proteins. Nutritional interventions that enhance the restoration of endogenous fuel stores and improve muscle damage repair have received a lot of attention. The primary aim of this project is to clinically test the effect of alginate encapsulation technology on performance. Furthermore, we will investigate the substrate utilization profile during exercise and subsequent recovery.

The encapsulation technology presents a nutrient delivery solution, which results in a sustained or slow-release of the nutrients encapsulated. Thus, potentially optimizing the digestion and absorption by promoting an easy ingestion of high concentrations of fx carbohydrates without negatively affecting the gastrointestinal comfort.


Eligibility Criteria:
Inclusion Criteria:

* males between 18-50 years of age
* moderate to trained individuals with a VO2max \> 50 ml/min/kg
* accustumed to exercising on a bike
* healthy volunteers

Exclusion Criteria:

* persons diagnosed with metabolic diseases (i.e. Type 2 Diabetes) which relates to the carbohydrate metabolism.
* persons ingesting prescribed drugs/medicin, supplements or a special diet (i.e. low carbohydrate), which might affect the glycogen synthesis and/or performance.
Lacticaseibacillus Rhamnosus GG Pili Study

The aim of this study was to investigate the host-microbe interaction effects of various Lacticaseibacillus rhamnosus GG strains, with different binding capacities to the mucus in the small intestine, in healthy individuals

The project consisted in the supplementation of a) a wild-type LGG strain, b) a low-producing pili LGG strain or c) a high-producing pili LGG strain to study subjects. The individuals received the three treatment combinations in a randomised order. Each supplementation was given to the individuals every 30 min over a period of 6 hours. Eight biopsies from the duodenum were collected at the end of 6 h-solutions administration by flexible gastroduodenoscopy, likewise the routine procedure during this endoscopic investigation. Faecal samples were collected by the study subjects at home 1 day before, 2, 7 and 14 days days after administrations of each oral supplementation. The supplementations were separated by a 3-week wash-out period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females aged 18-65 years.
* Willing to abstain from any probiotics or medication known to alter gastrointestinal function during the study.
* A signed informed consent.

Exclusion Criteria:

* Recent or current treatment with drugs affecting intestinal function, immune function or mood (e.g. antidepressants). In addition use of all drugs during the study should be recorded.
* Recent (\< 6 weeks) use of probiotics\*.
* Diagnosis of major psychiatric or somatic disorders.
* Pregnancy or breastfeeding.
* Abuse of alcohol or drugs.
* Smokers and chewable tobacco users.
* Lactose intolerance.

  * Any kind of probiotics and with special attention on products containing LGG:

Dairy products:

* Valio Kefir
* Valio Gefilus yoghurt

Dietary supplements:

* Bifiform Daily
* Bifiform Travel
* Bifiform Daily Caps
Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening

This research will compare the absolute volumes of the upper extremity using both the LymphaTech Scanner and Perometer in a cohort of patients with a history of invasive or in-situ carcinoma of the breast.

Our trial seeks to assess the efficacy of the LymphaTech Scanner as compared to the Perometer, which is currently used to screen for breast cancer-related lymphedema. The focus of the study is to compare the absolute volumes of the upper-extremity as measured by each device and to compare the time it takes to measure both arms of a patient using each device to assess clinical feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast and will undergo unilateral breast cancer surgery
* Age \>18 years.
* Ability to understand and the willingness to verbally consent to the trial

Exclusion Criteria:

* History of primary lymphedema.
* Any patient with a current case of cellulitis.
* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Participants unable to abduct upper-extremity perpendicular to body or to stand comfortably without aid for several minutes, both of which are necessary to perform a LymphaTech Scan
TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia

To evaluate the effect of dexmedetomidine as an adjuvant of ropivacaine in the TAP block on cesarean section parturients under multimodal analgesia, optimize the multimodal analgesia program for cesarean section, and guide perioperative analgesia managemen。This is a single center, double-blind, randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* 1) 37-42 weeks of gestation

  2) Plan cesarean section

  3) Receiving patient controlled intravenous analgesia

  4) Age\>18 years

  5) ASA（American Society of Anesthesiologists) grade I-III

  6) Voluntary participation and informed consent

Exclusion Criteria:

* 1)The anesthesia method for cesarean section is general anesthesia or intraspinal anesthesia, and epidural administration is used

  2) Combined with other opioids during operation

  3) High risk pregnancy (multiple pregnancy, in vitro pregnancy, etc.) or pregnancy related complications (hypertension, preeclampsia, chorioamnionitis, etc.)

  4) Times of previous cesarean section ≥ 3

  5) BMI ≥ 50kg/m2 is not suitable for TAP block

  6) Allergies or contraindications to the drugs involved in the study

  7) Combined with operations other than tubal ligation and ovariectomy

  8) Severe renal function impairment (SCR\>176 µ mol/L and/or blood urea nitrogen\>17.9 mmol/L), severe liver function impairment (ALT and/or aspartate aminotransferase exceed 3 times the upper limit of normal value)

  9) Increased risk of coagulation dysfunction or bleeding (PLT\<80 × 109/L or international normalized ratio\> 1.5)

  10) History of chronic pain or opiate abuse

  11) Other clinical trials in the last three months
Perianal Operating Scope Feasibliity

This protocol will test a new prototype of a peri-anal access device, with increased flexible length and a captured operative field, for feasibility in patients immediately prior to their scheduled peri-anal procedure.

Research Methods: The insertion of the modified access device in five patients before their planned peri-anal procedure, which will subsequently be performed with standard instruments, will allow us to observe the ease of insertion, the expansion of the blades, and the creation of the operative field achieved. If necessary, we will modify our design based on these findings. When a successful, operating room prototype is established, the device will be suitable for clinical use and the stated benefits thereof.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18 to 80
* In good health status
* Patients scheduled for a transanal procedure other than for anal lesions, e.g., hemorrhoids, fissures, abscesses

Exclusion Criteria:

* Patients with physical characteristics that distort the rectal sigmoid anatomy, e.g., spinal lesions.
* Patients considerable unsuitable for inclusion in the study by their colorectal surgeon.
* Patients considered too frail or ill by their physician to undergo a 5-10 minute prolongation of their procedure.
* Patients with known rectosigmoid infections.
* Patients with known rectosigmoid wall fragility.
* Patients with known rectosigmoid perforations.
Arm Spasticity - Non-Interventional Study Early BIRD (BoNT Treatment: Initial and Repeated Documentation)

Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms.

The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the "early" start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the "late" start of treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to data collection
* Hemiparesis and clinically relevant upper limb post-stroke spasticity
* Treated with Dysport® or with the intention to be treated with Dysport® according to local SmPC
* BoNT naïve or pre-treated with any BoNT product

Exclusion Criteria:

* Recurrent stroke
* Sensitivity to Dysport® or to its excipients or any other contraindications as given in the local SmPC for Dysport®