cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Hemoglobin Monitoring in Cesarean Section

Non-invasive hemoglobin monitoring will be performed in patients who underwent cesarean section with placenta previa and this will be compared with actual laboratory findings.

The investigators will investigate whether noninvasive hemoglobin monitoring can adequately reflect the massive bleeding that occurs within a short period of time and find out if it matches the actual laboratory findings.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* Elective Cesarean section
* Placenta previa

Exclusion Criteria:

* Decline of consent
* Peripheral vascular disease
* Cyanosis due to congenital heart disease
* Refusal of transfusion
* Mental retardation
T1D Closed-loop and Physical Activity

"Physical activity is recognized as beneficial for patients living with type 1 diabetes (T1DM), with a demonstrated effect not only on HbA1c control \[1\] but also on reducing the incidence of diabetes-related complications \[2,3\]. It is recommended that patients living with T1DM perform 150 minutes of accumulated physical activity per week, without exceeding two consecutive days without physical activity \[4\]. Indeed, one meta-analysis reported that moderately vigorous activity (≥4.5 METs) was beneficial compared with lower-intensity activity, while three other studies noted that only vigorous physical activity (≥6 METs) predicted lower all-cause mortality rates \[5\]. However, T1DM can represent a major obstacle to physical activity because of the occurrence of fairly frequent hypoglycemia, including after physical effort, the need for early resugaring but also the risk of hyperglycemia (rebound or with certain activities) \[6\]. The advent of automated insulin delivery systems has led to a significant improvement in time on target and a reduction in the frequency of hypoglycemia, including during physical activity in some studies \[7-9\]. The aim of this study is therefore to evaluate, in a cohort of patients with T1DM, whether the implementation of a closed-loop automated insulin delivery system increases physical activity in patients with T1DM. Based on the interpretation of the ONAPS-PAQ \[10\], the investigator hypothesize that the implementation of the closed-loop system enables an individual to reach the 3000 MET/min/week threshold (considered ""Active+"" from this threshold onwards).


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes defined by clinical history and positive measurement of autoantibodies (anti-GAD or IA2), evolving for more than 6 months and treated by insulin pump for at least 6 months, for whom an indication for automated insulin delivery is retained, by criteria of glycemic control (HbA1c ≥ 8% and/or significant glycemic variability and/or severe hypoglycemia) or poor quality of life, in accordance with reimbursement criteria validated by the CNAM for available systems.
* For women, existence of effective contraception (hormonal or mechanical) and no plans for pregnancy during the study period.
* Having a Health Care insurance."" "

Exclusion Criteria:

* Patient already involved in another experimental study
* Patient in a particular situation deemed incompatible with the study by the investigator
* Patient living in a department other than Alpes-Maritimes or Var
* Pregnant women
* Presence of a contraindication to physical activity
* Patient with linguistic or psychological incapacity to understand written information
* Patient refusing to give consent
* Patient deprived of liberty by administrative or judicial decision, under guardianship or trusteeship"" "
Evaluation of ORTHOPUS Partner Arm in People With Disabilities Needing for Robotic Assistance to Compensate for Upper Limb Deficiency

The study is a prospective, multicenter, interventional, open clinical trial, in Single Case Experimental Design (SCED) in multiple introduction withdrawal, controlled, randomized.

The function of the upper limb associated with gripping is essential for carrying out activities of daily living (ADL): personal care, productive activities, leisure, etc. The upper limbs therefore have not only a functional dimension (bringing together, moving away, holding, taking, bringing to the mouth, scratching, etc.) but also a social and anthropological one. As such, a limitation of functionality of the upper limb will have a very significant impact on the quality of life, independence, autonomy and participation of the subjects. When the impairment of a function is irreversible, rehabilitation care may involve the use of aids that either optimize or replace the function. Thus, the orthoses or devices used can either assist the movement if a minimum of muscular strength and control is still present, or completely replace the function if the functional deficit is complete. Using the proprietary robotic actuator, ORTHOPUS has developed the Partner for people with disabilities, with residual strength in the arm. This device is therefore intended for people with a loss of function in the upper limbs. It supports the mobility of the arm by anti-gravity compensation and must help to regain autonomy during ADLs. The Partner is CE marked and classified as a class 1 MD. The hypothesis of the Clinical Investigation is that the Partner medical device is effective in improving the functional capacities of the equipped upper limb (LM), in patients, children and adults, eligible for a robotic compensation Upper Limb Technical Aid, after a period of use of said technical aid in ecological conditions.

Eligibility Criteria:
Inclusion Criteria:

* Have a loss of mobility in the upper limb (UL).
* Have minimal functional capacities in the upper limb, defined by a score between 1 and 4 on the Lovett scale for all muscle groups of the arm, except for the hand and wrist.
* Demonstrate effective distal motor skills in the upper limb to be fitted.
* Be an informed patient who has provided signed consent, or in the case of minors, have given assent along with the signed consent of legal guardians.
* A relative must be available for the installation visit, and either the patient or the relative must have the necessary equipment to record videos in ecological conditions (smartphone or tablet).)

Exclusion Criteria:

* Patients with cognitive or behavioral dysfunctions that may compromise adherence to instructions and procedures required for the trial (at the discretion of the investigator clinician).
* Patients already enrolled in an interventional clinical trial.
* History of fractures in the upper limb to be fitted within the six months preceding the inclusion visit in the trial.
* Any conditions or injuries that may interfere with functional assessments.
* Patients under legal guardianship or curatorship.
* Lack of health insurance coverage.
Allogeneic Stem Cell Therapy in Heart Failure

The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem Cell Centre - Adipose Stem Cells (CSCC_ASC) study in heart failure patients to investigate the regenerative capacity of the CSCC_ASC treatment.

The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic CSCC_ASCs in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure in a double-blind placebo-controlled design.

A total of 81 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline).

The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. 30 to 80 years of age
2. Signed informed consent
3. Chronic stable ischemic heart disease
4. Symptomatic heart failure - New York Heart Association (NYHA) class II-III
5. EF ≤45%
6. Plasma NT-pro-BNP \> 300 pg/ml (\> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP \> 422 pg/ml (\> 450 pmol/L) in patients with atrial fibrillation
7. Maximal tolerable heart failure medication
8. Medication unchanged two months prior to inclusion
9. No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
10. Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis
11. Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device

Exclusion Criteria:

1. Heart Failure (NYHA I or IV)
2. Acute coronary syndrome with elevation of creatine kinase (CK) isoenzyme MB (CKMB) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
3. Other revascularisation treatment within four months of treatment
4. If clinically indicated the patient should have a coronary angiography before inclusion
5. Moderate to severe aortic stenosis (valve area \< 1.3 mm2) or valvular disease with option for surgery.
6. Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) \<1 L/min, moderate to severe claudication or morbid obesity
7. Clinical significant anaemia (haemoglobin \< 6 mmol/L), leukopenia (leucocytes \< 2 109/L), leucocytosis (leucocytes \>14 109/L) or thrombocytopenia (thrombocytes \< 50 109/L)
8. Anticoagulation treatment that cannot be paused during cell injections
9. Patients with reduced immune response
10. History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
11. Pregnant women
12. Other experimental treatment within four weeks of baseline tests
13. Participation in another intervention trial
Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®

This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
* Received at least one injection of OZURDEX® in the study eye

Exclusion Criteria:

* None
Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement

We propose a randomized, double-blind controlled trial comparing arthroscopic release with arthroscopic debridement for the management of chronic tennis elbow in an effort to definitively determine whether arthroscopic tennis elbow release is an effective treatment of tennis elbow, and to further provide better recommendations for the use of this procedure, in an effort to improve patient care.

Lateral epicondylitis (tennis elbow) is a common occurrence in the general population with an incidence of 4-7/1000/year. More recent literature describes a 1-3% rate over the course of a lifetime, most typically affecting individuals between the ages of 35 and 50.

Tennis elbow is a common occurrence in the general population that causes lateral elbow pain and diminished grip strength, which may be debilitating. Most affected individuals achieve symptom resolution within 6 months to 1 year with measures such as physiotherapy, anti-inflammatories and corticosteroid injections, but a small subset will go on to develop chronic symptoms. Chronic tennis elbow can be treated surgically, by arthroscopic tennis elbow release (ATER), which has gained popularity in recent years as it presents a less invasive option, allows for direct visualization of the elbow joint for other pathology and has a faster return-to-work time compared to other surgical procedures. Despite its promise there have been no high quality studies evaluating the efficacy of arthroscopic tennis elbow release, bringing the actual efficacy of this procedure into question. A randomized controlled trial on arthroscopic tennis elbow release would provide much needed evidence in order to define its role in the management of tennis elbow and to help refine treatment protocols.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms consistent with lateral epicondylitis persisting for \>6 months, and have failed conservative management
* Adult, skeletally mature (\>18yrs)
* Provision of informed consent

Exclusion Criteria:

* Alternative diagnosis that better explain their symptoms
* Previous elbow trauma or surgery
* Case involving workplace insurance claims (e.g. WSIB)
* Unwilling, or unlikely in the opinion of the investigator to be followed for the duration of the study (e.g., patient refusal, unfixed address, plans to move...etc.)
* Cognitive difficulties that prevent ability to provide informed consent and reliable completion of questionnaires
* Bilateral lateral epicondylitis
Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy

The purpose of the research is to: develop an educational website to empower Black and African American cancer patients to make informed decisions about personalized cancer treatment and clinical trials. The sample size for the qualitative interviews was (n=48) when saturation was achieved. With a goal of (n=30) for the pilot trial, the overall target sample size for the study is (n=78).

The website offers tools for discussing innovative treatments with their clinicians, finding clinical trials, and locating support groups. We are conducting key informant interviews, testing the website with pilot tester and asking volunteers from our Community Advisory Board to review our website prototype to further improve its design and features.

Eligibility Criteria:
Inclusion Criteria

Patient Key Informant:

* Age 18 and older
* Self-identify as Black/African American
* Diagnosed with solid tumor
* Able to read and speak English fluently
* Able to provide informed consent
* Able to complete 1 survey and an in-depth interview

Relative Key Informant:

* Age 18 and older
* Spouse, blood relative, or caregiver of a cancer patient who identifies as Black/African American
* Able to read and speak English fluently
* Able to provide informed consent
* Able to complete 1 survey and an in-depth interview

Provider Key Informant:

* Age 18 and older
* Physician, nurse, social worker, patient navigator, or financial counselor
* Work in oncology setting
* Able to read and speak English fluently
* Able to provide informed consent
* Able to complete 1 survey and an in-depth interview

Pilot Tester:

* Age 18 and older
* Self-identify as Black/African American
* Able to read and speak English fluently
* Able to provide informed consent
* Newly diagnosed with solid tumor cancer (Stage I-IV)
* Have not yet consulted with an oncologist regarding treatment
* Able to complete 2 surveys and an in-depth interview

Exclusion Criteria

Key informants will be excluded from the study if they do not meet the inclusion criteria. Pilot testers will be excluded from the study if they previously participated as key informants and do not meet inclusion criteria.
The Effect of the COVID-19 Epidemic Process on the Nutritional Habits and Body Weights of Adults

During the COVID-19 epidemic, the time spent by adults on the stomach has increased. Therefore, the likelihood of adverse changes in lifestyles has increased. In this study, the changes in nutritional habits, physical activities and body weights of adult individuals during the epidemic will be evaluated. A questionnaire including questions about nutritional habits, physical activity status and changes in body weights will be administered to individuals. The results will be evaluated with the appropriate statistical method. The survey will be administered once. The estimated time to reach the total number is 3 months.


Eligibility Criteria:
Inclusion Criteria: Adult individuals wishing to participate in the study -

Exclusion Criteria: Individuals outside the age range of 19-70 years, all individuals who did not agree to participate in the study.

-
Effectiveness of Play Interventions on Anxiety Among Hospitalized Children

The study evaluates the effectiveness of play interventions on anxiety among hospitalized children in selected hospital of Yamuna Nagar, Haryana. Quasi experimental approach was adopted. 60 (30 in experimental and 30 in comparison)hospitalized children were selected by purposive sampling technique.Hospitalized children in experimental group were provided play interventions whereas the children in Comparison group received only usual medical and nursing care.

TSetting was selected by randomization (by lottery method) first selected two rooms from General Pediatric Wards were coded as E1 (Experimental 1) and E2 (Experimental 2) whereas next two were coded as C1 (Comparison 1) and C2 (Comparison 2).

From the selected settings 60 subjects (30 in experimental and 30 in Comparison) were selected by purposive sampling technique. Assessment of anxiety (Pre-test) of the hospitalized children admitted in Aashirwad Hospital was done in experimental group and Comparison group on 1st day. In Experimental group after taking pretest play interventions were introduced to the children and instructions regarding the way to play with all the interventions were provided to the children. Though all the children were free to choose the play yet the younger children were given simple and easy play interventions such as drawing, coloring etc. to obtain more sensory experience whereas the older children were offered play interventions such as puzzle, building blocks, ludo etc. with high cognitive demand. The play interventions were administered for 1 hour daily from day 1 to day 5 whereas in Comparison group all the subjects were given usual general nursing and medical care for continuous 5 days. No intervention was administered to the comparison group. Posttest anxiety was assessed on 5th day.

Intervention to the control group was given after the accomplishment of Post test for ethical consideration.

Eligibility Criteria:
Inclusion Criteria:

* The study include hospitalized children who were:

  1. aged 6-12 yrs. admitted in the pediatric general medical unit.
  2. anxious due to hospitalization.
  3. willing to participate in the study.
  4. alert, oriented, comprehend and able to speak and understand Hindi language.

Exclusion Criteria:

The study exclude hospitalized children who were:

* 1. treated as outpatient
Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy

Evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a multi-center population of children with a post-chemotherapy febrile neutropenia


Eligibility Criteria:
Inclusion Criteria:

* Child aged 1 to 18 years
* Child with hematology or cancer
* Child with a febrile neutropenia post-chemotherapy
* Child with social security
* No opposition from the child and/or parents, in case of absence, the holder of the parental authority present, can consent, alone, to the participation of the unemancipated minor.

Exclusion Criteria:

* Febrile neutropenia at diagnosis of tumor disease
* Child with palliative care
* Child having had a hematopoietic stem cell allo-graft in the preceding year
* Febrile neutropenia immediately post auto-transplant
* Antibiotherapy prior to admission
* Initial care in a non-investigative center.
A Study of Ruxolitinib in Pancreatic Cancer Patients

This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 270 participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were to be randomized (1:1) to one of the following treatment groups:

* Treatment A (N = 135): Capecitabine + ruxolitinib
* Treatment B (N = 135): Capecitabine + placebo

Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered during the entire cycle. Treatment for all participants was to continue as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued treatment continued to be followed for subsequent anticancer treatments and survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas.
* Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
* ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
* Radiographically measurable or evaluable disease
* An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

  * Criteria:

    1. mGPS of 1: C-reactive protein (CRP) \> 10 mg/L and albumin ≥ 35 g/L
    2. mGPS of 2: CRP \> 10 mg/L and albumin \< 35 g/L

Exclusion Criteria:

* Received more than 1 prior regimen for advanced or metastatic disease.
* Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment
* Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
* Current or previous other malignancy within 2 years of study entry without sponsor approval
* Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), ruxolitinib, or any of their excipients.
* Prior treatment with a JAK inhibitor for any indication.
Effectiveness of Mulligan Mobilization Technique And Cervical Stabilization Training in Patients With Chronic Neck Pain

The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively.

The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively.

The hypotheses we will test for this purpose; H1. Home exercise program will improve positively after treatment in patients with chronic neck pain compared to before treatment.

H2. Mulligan mobilization will improve positively after treatment in patients with chronic neck pain compared to before treatment.

H3. Cervical stabilization training will improve positively after treatment in patients with chronic neck pain compared to before treatment.

H4. Mulligan mobilization will provide more effective results in patients with chronic neck pain compared to other applications.

Eligibility Criteria:
Inclusion Criteria:

* Having neck pain lasting more than 3 months
* Expressing neck pain at least 3,5/10 points and above on a Visual Analog Scale
* Being 18-65 years old
* Agree to participate in the study
* Having obtained 5/50 points and above in Neck Disability Index

Exclusion Criteria:

* Having had spinal surgery
* Other musculoskeletal problems that may affect the cervical region such as impingement, thoracic outlet and scoliosis.
* Having a diagnosed psychiatric illness
* Having benefited from physiotherapy and / or another treatment method due to spinal pain problem in the last 1 year.
* The presence of specific pathological conditions such as malignant condition, fracture, systemic rheumatoid disease.
* Any health problem that may prevent the application of evaluations and / or treatment other than those mentioned above.
* Difficulty in communication at a level that prevents the application of evaluations and / or treatment.