cyrilzakka/clinical-trials huggingface dataset:
Lower Limb Surveillance During VA-ECLS

Temporary cardiac support by VA-ECLS can lead to lower limb ischemia. The aim of this study is to evaluate a multi-modal strategy (physical examination, NIRS monitoring and angiography through the reperfusion canula) of lower limb surveillance.

VA ECLS is used as a temporary circulatory support during cardiogenic shock and refractory cardiac arrest. Complications of VA ECLS include hemorrhagic, infectious and ischemic events. VA ECLS requires arterial and venous canules which are frequently positioned in the femoral artery and vein, which carries the risk of lower limb ischemia due to retrograde flow and obstruction of the femoral artery lumen. VA ischemia during VA ECLS is frequent (11-52%) and requires the use of reperfusion canula in the femoral common artery on VA ECLS implantation in a primary prevention strategy, before lower limb ischemia occurs. Even with this strategy, lower limb ischemia can occur due to arterial thrombosis, arterial spasm or insufficient blood flow through the reperfusion canula. Lower limb complications are prevented by monitoring of regional oxygen saturation, control of the reperfusion canula position (ultrasound, angiography) and rapid management when lower limb ischemia is suspected. There are no clear recommendations regarding prevention of lower limb complications during VA ECLS and arterial angiography has been described to diagnose ischemic events and evaluate the effectiveness of an intervention such as injection of vasodilators. This study is a prospective evaluation of a strategy to prevent lower limb complications during VA ECLS with a systematic arterial angiography on VA ECLS implantation and when lower limb ischemia is suspected (regional oxygen tissue saturation \<50% or a differential \>15% between both lower limbs) in addition to continuous NIRS monitoring of lower limbs during VA ECLS.

Eligibility Criteria:
Inclusion Criteria:

* Temporary circulatory support with VA ECLS
* Age \> 18 years

Exclusion Criteria:

* Pregnancy
* History of iodinated contrast allergy
* History of lower limb amputation above the ankle
* Lower limb ischemia before starting of VA-ECLS
* Femoro-axillary VA-ECLS
* Absence of the lower limb reperfusion canula
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541)

The purpose of this study is to evaluate the ability of injections of Ji Gami(TM) N and Ji Gami(TM) NDO to induce hair growth in male and female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18 to 65 years old, inclusive
* Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
* Able to provide informed consent after risks and benefits of the study have been explained.
* Be willing to undergo all study procedures.
* Ability to communicate effectively with study personnel.
* Have no clinically significant disease or abnormal laboratory evaluations taken at the screening visit.
* Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study.

Exclusion Criteria:

* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used minoxidil or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Participation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Clinically significant dermatologic condition in donation or study areas.
* Prior surgery in the donor or study areas.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program

The purpose of this study is to measure the impact of a checklist-based childbirth safety program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in north India.

The WHO Safe Childbirth Checklist Program is a quality improvement program designed to support health workers to deliver evidence-based practices to women and newborns around the time of institutional childbirths. At the program's core is the Safe Childbirth Checklist, a 31-item list of essential practices that target the major causes of maternal and newborn mortality in low-resource settings globally. The program was developed over 3 years by a partnership of WHO and HSPH, working with a large international network of experts and stakeholders in maternal, fetal, and newborn health. Pilot testing of the program at a public-sector birth center in south India demonstrated dramatic improvements in health worker adherence to essential childbirth-related clinical care standards. The current study is a matched-pair, cluster randomized trial to measure the efficacy of the program in reducing severe maternal and newborn harm. This trial will be conducted at approximately 120 health facilities in Uttar Pradesh, India.

Eligibility Criteria:
Inclusion Criteria:

* For measuring outcomes, inclusion criteria are all mothers admitted to a study site for childbirth and newborn babies who are to be followed-up. In case a mother or baby from an enrolled site is referred out to another facility (before or after delivery) the mother-baby dyad will be included in the study and the outcome will be allocated to the referring facility
* For a smaller subset of birth events (approximately 4,650 deliveries total), health worker practices will be observed to measure the impact of the SCC program on delivery of essential practices, as a secondary outcome. A convenience sample of women who agree to observation and their babies cared for by the health workers around the time of childbirth at the facility during data collectors' duty hours will be included in this component of the study.

Exclusion Criteria:

* Mothers who have been referred into the facility by an inter-facility transfer.
* Mothers being managed for abortion.
* Mothers who refuse consent for follow-up
Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit in Treating Patients With Adhesive Capsulitis

This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus hydrodilatation with steroid with axillary nerve injection for treating patients with adhesive capsulitis.

Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis.

Design: a prospective, single-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided hydrodilatation with steroid via posterior approach) and group 2 (ultrasound guided hydrodilatation with steroid via posterior approach as well as axillary nerve injection). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, and Shoulder Pain And Disability Index.

Eligibility Criteria:
Inclusion Criteria:

1. age 35-65 years (to prevent the inclusion of patients with secondary AC),
2. onset of shoulder stiffness since over a month
3. limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion Criteria:

1. ultrasound findings of rotator cuff tears
2. plain radiography findings of significant glenohumeral joint arthritis
3. accompanying cervical radiculopathy
4. systemic inflammatory joint disease
5. intra-articular injection into the glenohumeral joint within the past 3 months
6. history of surgery on the affected shoulders
7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids
8. allergy to corticosteroid or lidocaine. -
Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS

To explore the efficacy and safety of prolonged low-dose decitabine (10 days of 6mg/m2) plus venetoclax (3 weeks/cycle) regimen in primary diagnosed elderly or frail AML/ high-risk MDS.

Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are hematological malignancies. Some patients are over 65 years old, have poor response to traditional chemotherapy, and rarely have the opportunity to receive allogeneic hematopoietic stem cell transplantation, resulting in poor prognosis and short survival.

In recent years, with the advent of molecular targeted drugs Bcl-2 inhibitors, the treatment of elderly AML/ high-risk MDS has achieved breakthrough progress. In particular, the combination of demethylated drugs (decitabine/azacidacidin) and Bcl-2 inhibitors of chemotherapy-free regimen has been recommended by NCCN as the first-line treatment for elderly and frail patients.

However, how to achieve the optimal combination of decitabine and Bcl-2 inhibitors is an urgent problem to be solved.

Our previous pilot trial showed that prolonged low-dose decitabine combined with venetoclax (Bcl-2 inhibitor) resulted in higher complete remission rate, longer disease-free survival, and lower treatment-related risks.

The purpose of this study was to expand the multi-center sample to explore the efficacy and safety of prolonged low-dose decitabine plus venetoclax regimen in primary diagnosed elderly or frail AML/ high-risk MDS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be diagnosed with acute myeloid leukemia (non-acute promyelocytic leukemia)/high-risk myelodysplastic syndrome before admission.

   Diagnostic criteria refer to 2016 WHO classification.
2. Age 60 or older.
3. The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1).
4. Creatinine clearance ≥30 mL/min(as assessed by the Cockcrod-Gault formula \[Cockcroft et al 1976\] \[13\] or the estimated glomerular filtration rate \[eGFR\] from the Kidney Drink adjustment formula .
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN.
6. Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50% (AHA 2016).
7. Life expectancy \>8 weeks.
8. Sign the informed consent voluntarily, and understand and comply with the requirements of the study.

Exclusion Criteria:

1. Age \<60 years old.
2. Treated patients who had received various chemotherapy regiments.
3. Present clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale (see Appendix 2), or history of myocardial infarction in the 6 months prior to screening.
4. Other serious diseases that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes).
5. Those who cannot understand and follow the research plan or sign the informed consent.
Ablation for ICD Intervention Reduction in Patients With CAD

The aim of this study is to assess the role of ablation in appropriate ICD interventions reduction in patients with coronary artery disease. The group will consist of 200 patients with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The patients will be randomized into ablation arm and conventional treatment. Number of appropriate ICD interventions is the primary endpoint of this study. All patients will have control follow-up visits every 3 months. The follow-up will be based on ICD memory.


Eligibility Criteria:
Inclusion Criteria:

* Coronary Artery Disease
* ICD implanted
* Appropriate ICD intervention during the 3 months prior to enrollment
* Coronary angiography during the 6 months prior to enrollment
* Possible revascularization
* Age over 18 years
* Signed informed consent

Exclusion Criteria:

* Age less then 18 years
* Pregnancy
* Active participation in other trial
* Heart failure (NYHA IV)
* Contraindications for ablation procedure: i.e. left ventricular thrombus, artificial aortic or mitral valve, no vascular access.
* Monomorphic, incessant, ventricular tachycardia
* Revascularization or other cardio-surgical procedure scheduled in the next 6 months
Control of MRSA in Nursing Homes: Decolonization vs Standard Precautions

The purpose of this study is to determine the better approach between the currently procedure (i.e. standards precautions) and a reinforced strategy to control MRSA transmission in the institutionalized population of nursing homes in Canton of Vaud, Switzerland.

MRSA carriage among nursing homes residents of Canton Vaud, Switzerland, is increasing, despite use of standard precautions. Recommendation to prevent MRSA transmission in long term care facilities are lacking. We aim to reinforce the current infection control strategy by general MRSA screening of institutionalised residents and decolonisation of MRSA carriers. Because the uncertainties in the impact of this reinforced strategy, we aim to compare this action to the policy actually applied.

Eligibility Criteria:
Inclusion Criteria:

* all nursing homes of canton Vaud, Switzerland, that give the consent of participation

Exclusion Criteria:

- refusal to participate

Inclusion criteria for decolonisation in intervention nursing homes:

- all MRSA positive residents living in a Nursing Home included in the intervention group

Exclusion Criteria for decolonisation:

* residents that refuse to be screened or refused the decolonisation
* life expectancy shorter of 7 days
* known intolerance of disinfectant/ topical antibiotics used in the protocol
* active MRSA infection
* asymptomatic MRSA bacteriuria
* stage IV wound (according to National Pressure Ulcer Advisory Panel)
Glaucoma Adherence Study, Spain

The purpose of this study is to evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid.

This study was conducted in Spain. An identical study was conducted in France, UK, Italy, and Netherlands under Protocol ID EMD-07-01. A combined enrollment number is presented.

Eligibility Criteria:
Inclusion:

* Provide informed consent.
* Able to follow instructions and be willing and able to attend required study visits.
* Able to read and complete study questionnaires.
* Clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye.
* Intraocular pressure considered safe, in both eyes, assuring clinical stability of vision and the optic nerve throughout the trial.
* Currently treated with DuoTrav alone, dosed in the evening for at least for 30 days, at Visit 1.
* Best corrected visual acuity of 20/200 Snellen or better in each eye.
* Intraocular pressure ≤ 30 mm Hg in both eyes.
* Evidence causing the investigator to consider the patient to be non-adherent, at some level, to their glaucoma medication.
* Agree that their adherence could be improved by the intervention with the dosing aid described in this study.
* Other protocol-defined inclusion criteria may apply.

Exclusion:

* Presence of other primary or secondary glaucoma not listed in inclusion criterion.
* Any abnormality preventing reliable applanation tonometry in the study eye(s).
* Any known opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of the study eye(s).
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
* Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1.
* Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
* Progressive retinal or optic nerve disease from any cause.
* Women of childbearing potential not using reliable means of birth control.
* Women who are pregnant or lactating.
* A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
* Participation in any other investigational study within 30 days prior to Visit 1.
* Known medical history of allergy, sensitivity or poor tolerance to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator.
* Unwillingness to risk the possibility of darkened irides, eyelash changes or periocular pigmentation.
* History of, or at risk for uveitis or cystoid macular edema (CME).
* Any physical disability which prevents the accurate use of the Travalert™ dosing aid.
* Unable to accurately instill the travoprost/timolol fixed combination in the evening.
* Other protocol-defined exclusion criteria may apply.
Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

The goal of this study is to learn how to engage individuals with bipolar disorder in long-term monitoring of daily patterns of mood, stress, sleep, circadian rhythm, and medical adherence. Knowledge gained will be used to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder into an effective adaptive intervention.

Bipolar disorder is a chronic illness of profound shifts in mood ranging from mania to depression. Bipolar disorder is successfully treated by combining medication with psychosocial therapy, but care can prove inadequate in practice. With gaps in coverage and medication, along with imprecise guidelines on when, where, and how to intervene, promising psychosocial therapies require adaptive strategies to better address the specific needs of individuals in a timely manner. To accomplish this, however, requires evidence-based practices for adapting a psychosocial therapy. The long-term goal of this study is to address this knowledge gap, by establishing a mobile health platform for translating a psychosocial therapy in bipolar disorder into an effective adaptive intervention.

An important first step and the specific goal of this study is to answer the question of how to engage individuals with bipolar disorder in long-term monitoring of their daily patterns of mood, stress, sleep, circadian rhythm, and medical adherence. To answer this question, individuals with bipolar disorder will interact with a smart-phone application and activity tracker over six weeks. Individuals will record their symptoms twice-daily with the smart-phone application while activity, sleep, and heart rate are recorded with their activity tracker. In addition, individuals will be interviewed on a weekly basis. The study focuses on testing three engagement strategies: using activity trackers rather than self-reports; reviewing recorded symptoms with another person on a weekly basis; and synthesizing a person's data into charts and graphs.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with bipolar disorder
* Individuals with a smart-phone

Exclusion Criteria:

* None
Different Approaches for the Management of Post-dural Puncture Headache

Detecting the efficacy and safety of trans-nasal sphenopalatine ganglion block using either lidocaine 2% or bupivacaine 0.5 % as a treatment line for post-dural puncture headache


Eligibility Criteria:
Inclusion Criteria:

* The ASA physical condition І-П
* the patient underwent CS under spinal anesthesia
* The headache developed within 5 days after the dural puncture
* There is no different explanation for the headache

Exclusion Criteria:

* coagulopathy
* history of nasal bleeding
* nasal polyp
* septal deviation
* local anesthetics reaction
Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis

This study is intended to evaluate the potential to relieve the symptoms associated with gastroparesis during 12 weeks of treatment with oral tablets given twice a day of GM-611 5mg, 10mg or placebo to type I or II diabetics who require insulin.

Additionally the study will evaluate the safety and tolerability of GM-611 compared to placebo, the levels of GM-611 in the blood, and the possible effect of GM-611 on diabetic control.


Eligibility Criteria:
Inclusion Criteria:

Major Inclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you have/are:

* Must be at least 18 years of age and have diabetes mellitus requiring insulin, which may be in addition to oral anti-diabetic agents.
* At least a three month history of the symptoms of gastroparesis that may include: early satiety (feeling full soon after beginning a meal), persistent fullness (long after eating), abdominal distention or bloating, nausea and vomiting. - No evidence of mechanical gastric obstruction, or other gastric problems since the onset of gastroparesis symptoms.
* You may be required to under go a Gastric Emptying Test (GET) procedure.
* You must be willing and able to maintain a daily telephone diary and consent to participate in this study.

Exclusion Criteria:

Major Exclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you do not have/are not:

* Prior history of gastric surgery, excluding reflux surgery.
* Inability to withdraw from current prokinetic agents (e.g., metoclopramide, erythromycin, others) prior to, and during the study.
* Unstable current medical or surgical condition, or a recent history of frequent hospitalizations.
* A history of: HIV, recurring infection affecting the gastrointestinal track, cirrhosis, acute or chronic liver disease, active pancreatitis, cholecystitis, psychosis, severe depression, Parkinson's disease, myopathy, scleroderma, eating disorder, or organ transplant.
* Evidence or history of QT-prolongation, or use of drugs that are, or may be associated with QT-prolongation are prohibited.
* May not be pregnant, breast-feeding or not using approved methods of contraception.
* An allergy or intolerance to macrolide antibiotics (e.g., erythromycin).
* Use of any investigational drug within 30 days prior to screening.