cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma

The aim of this study is to assess the results of subliminal subthreshold transscleral diode cyclophotocoagulation in refractory glaucoma using the standard technique of 360 degree application and to compare the outcome with a modified technique both in terms of efficacy and safety.

Refractory glaucoma is glaucoma that doesn't respond favorably to surgical and/or medical treatment to lower intraocular pressure. It can include primary open angle glaucoma, primary angle closure glaucoma, neovascular glaucoma or silicone oil-induced glaucoma. Cyclophotocoagulation (CPC) is a form of cycloablation using laser to treat glaucoma. It involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting in a reduction in aqueous secretion and hence intraocular pressure. Transscleral cyclophotocoagulation using a continuous diode laser has been a treatment option in advanced glaucoma cases with s¬¬uboptimal IOP control, for a long time. High treatment energy used by diode laser cyclophotocoagulation was argued to be associated with increased frequency of serious complications such as vision loss, hypotony, and phthisis. These concerns necessitate modulation of the parameters of laser treatment used.

Micropulse transscleral cyclophotocoagulation (MP-TSCPC), which is a variation of conventional continuous-wave CPC, has emerged as an attractive alternative for the treatment of many types of glaucoma. It breaks the continuous wave laser into multiple short and repetitive pulses that allow the tissue to cool down between applications, thus reducing thermal damage. This strategy delivers very short energy pulses followed by rest periods, which is known as "duty cycle" and is defined as the ratio of time that a laser is delivering energy vs resting (ON/OFF). For this procedure, an infrared diode laser is used to stimulate the ciliary body structures and the uveoscleral pathway. This way it reduces the production of the aqueous humour and facilitates the uveoscleral outflow, with IOP reduction as a final effect.

Despite promising results, only few clinical studies are published on MP-TSCPC and most of them are retrospective studies refer to patients having previous continuous wave transscleral cyclophotocoagulation. Moreover, Several parameters and protocols have been studied in other reports in an attempt to refine the standard technique aiming to improve the outcomes without increasing the adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* patients with refractory glaucoma (IOP \> 21 mmHg unresponsive to maximally tolerated antiglaucoma medications, previously failed surgical treatment, or both)

Exclusion Criteria:

* Ocular inflammation.
* Ocular infection.
* Recent ocular surgery in the study eye in the 2 months prior to enrolment.
Continuous Spinal Anesthesia Versus Epidural Anesthesia in Geriatric

60 patients aged older than 60 years, American Society of Anesthesiologists (ASA) class II or III and scheduled for major hip surgery will be randomized, in to two groups anesthetized using continuous spinal anesthesia or using continuous epidural anesthesia.

60 patients aged older than 60 years, American Society of Anesthesiologists (ASA) class II or III and scheduled for major hip surgery will be randomized, in to two groups anesthetized using continuous spinal anesthesia or using continuous epidural anesthesia.

In continuous spinal anesthesia group 22 G catheter with priming volume0.1m The Catheter will be then fed over the needle into the intrathecal space and Inserted 3cm cephalad into the subarachnoid space.The spinal needle and the modified Tuohy needle will be then removed, and a Luer connector and A filter previously filled with the anesthetic solution will be attached to the Catheter (priming volume 0.6ml). Plain bupivacaine 0.5% in 20ml vials will Be used CSA group received 1 ml(5 mg) of plain bupivacaine (0.5%) Together with fentanyl l25μg injected via the catheter at a rate of 0.2ml/15s. The level of the resulting sensory blockade will be tested using pin prick.

Continuous epidural anesthesia Group A Perifix 401filter epidural set.It is composed of Tuohy epidural needle1.3×80 mm (18G);an epidural catheter with three lateral openings 0.85×0.45×1000 mm (20G); loss-of-resistance syringe, 10 ml; a Perifix flat filter 0.2μm; and Perifix screw connector. The needle is advanced until the epidural space is identified by the loss-of-resistance technique, and then a 20G catheter is inserted 3 cm cephalad into the epidural spac e. a test dose of 3ml of 2% lignocaine with adrenaline (1:200000) will be injected into the catheter. Three minutes later, 10 ml of plain bupivacaine (0.5%) together with fentanyl l50μg will be injected via the catheter. If the sensory blockade don't reach T10 within 20 min of the administration of the initial dose, additional doses of 5 ml of plain bupivacaine 0.5% will be injected epidurally every10 min until the level of T10 or amaximum of 25 ml of plain bupivacaine 0.5 % will be achieved. If the sensory blockade don't not reach T10, anesthetic failure will be considered, and the patients will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* patients aged older than 60 years
* American Society of Anesthesiologists (ASA) class II or III
* scheduled for major hip surgery

Exclusion Criteria:

* -Refusal
* Infection at the injection site
* Spinal deformity
* Neuropathy
* Allergy to local anesthetics
* Coagulopathy
The Effect of Osteopathic Manipulative Treatment on Recovery of Coronary Bypass Patients

The purpose of the study was to determine the effect on recovery after surgery of patients who received a standardized daily protocol of osteopathic manipulative treatment.Patients undergoing elective coronary artery bypass surgery were voluntarily enrolled in the study and assigned to one of three groups.One group received a standardized daily treatment protocol along with conventional care, another received daily similar placebo treatment with conventional care, and a final group received only conventional post surgical care.The research hypothesis was that daily treatment with osteopathic manipulative treatment would reduce hospital stay and hasten recovery from surgery.Persons in the treatment group had earlier discharge, and faster recovery of bowel function and basic mobility.

Fifty-three persons were voluntarily enrolled into this randomized, double-blinded placebo controlled trial to examine the effects of osteopathic manipulative treatment (OMT) on the post operative recovery of persons undergoing elective coronary artery bypass graft (CABG) surgery. Participants were assigned randomly to one of three cohorts: one with only conventiobnal treatment, one with a daily standardized protocol of OMT and a third with a daily time matched placebo OMT protocol.All patients received standard state of the art care consistent with national standards of post CABG care. The study showed favorable trends in terms of hospital length of stay , return of bowel function, and mobility.

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing elective coronary artery bypass graft surgery who were patients of the same surgeon

Exclusion Criteria:

* prior coronary artery bypass graft procedure
* unstable psychiatric illness
* chronic pain
* open chest phenomenon
* unforeseen peri or postoperative complications
A Brief Mindfulness-Based Intervention for Suicidal Ideation

The primary aim of this study is to determine whether a Brief Mindfulness-Based Intervention for Suicidal Ideation (MB-SI) is feasible and safe to implement. The secondary aims are short and longer-term reduction in suicidal ideation (SI) and/or suicide-related behaviors (SRBs) as well as improvements in mindfulness and emotional regulation measures compared to Treatment as Usual (TAU).

The study feasibility will be assessed through participant enrollment and retention numbers. The safety be monitored by the study personnel and include reporting any adverse effects. The intervention fidelity will be aided by standardizing the intervention and ensuring study personnel has the appropriate trainings. Participants will completed questionnaires assessing their SI and SRB as well as mindfulness and emotional regulation measures at three time points (preintervention, immediately postintervention, and 1-month postintervention) and their results will be compared between MB-SI and TAU groups. Additionally, the comparisons will also be conducted for the Emergency Department (ED) admissions, Inpatient Psychiatric Unit (IPU) admissions, and psychiatric ED admissions.

Eligibility Criteria:
Inclusion Criteria:

* Admitted with suicidal ideation and any active psychiatric or addictive disorder diagnosis.

Exclusion Criteria:

* Diagnosis of psychotic spectrum illness and current psychotic symptoms or significant cognitive impairment.
Saline Against Lactated Ringers or Plasmalyte in the Emergency Department

This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A) for intravenous fluid administration in the emergency department.

The administration of intravenous fluids is ubiquitous in the care of the acutely ill. Commonly available isotonic crystalloid solutions contain a broad spectrum of electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SaLt-ED will be a large, cluster-randomized trial enrolling adults requiring intravenous isotonic crystalloid administration and hospital admission from the Vanderbilt University Emergency Department from January 1st 2016 until April 30 2017. The primary endpoint will be hospital-free days to day 28.

Eligibility Criteria:
Inclusion Criteria:

1. Patient in the Vanderbilt Adult Emergency Department
2. Felt by treating clinician to require intravenous isotonic crystalloid
3. Felt by treating clinician to require inpatient hospital admission

Exclusion Criteria:

1. Age \< 18 years
Feasibility and Safety of Fasting in Fertility Treatment

This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility

This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in infertility. The participants will be randomized in two groups: fasting and waiting list. All groups will be trained and accompanied by medical experts and dieticians. In addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 25 to 45 years
* Unfulfilled desire to have children \>1 year
* declaration of consent
* 20 kg/m² ≤ BMI ≤ 40 kg/m²

Exclusion Criteria:

* Language barriers
* Previously known serious mental illness or cognitive impairment
* Patients with anatomical/organic damage and proven uterine abnormalities
* Eating disorders in the medical history
* Serious previous internal diseases
* Lack of internet access
* No consent to randomisation
* Participation in other studies
Different Targeted Antibody-drug Conjugates For HER2 Ultra-low or No Expression Advanced Breast Cancer（GALAXY）

This is a phaseⅠb/Ⅱ, open-label, two-arm parallel study evaluating the efficacy and safety of different targeted antibody-drug conjugates for HER2 ultra-low or no expression advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

ECOG Performance Status of 0 or 1

Pathologically documented breast cancer that:

1. is advanced or metastatic
2. is histologically confirmed to be HER2 IHC 0 (ISH- or untested)
3. was never previously HER2-positive (IHC 3+ or ISH+) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.

Disease progression on at least 1 previous line of chemotherapy for recurrent/metastatic breast cancer. Subjects with HER2-negative and hormone-receptor positive tumors must have progressed after at least 1 line of endocrine therapy with or without CDK4/6 inhibitor.

Has protocol-defined adequate organ and bone marrow function. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

Has previously been treated with any anti-HER2 therapy. Known prior severe hypersensitivity to investigational product or any component in its formulation and other monoclonal antibodies.

Any major surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.

History of other malignancy than breast cancer within 5 years prior to screening (except for cured skin basal cell carcinoma and cervical carcinoma in situ).

Meningeal metastasis or active brain parenchymal metastasis. Any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of \> 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration.

Has uncontrolled intercurrent illness or significant cardiovascular disease. History of clinically significant lung diseases. History of immunodeficiency, including HIV positive. Known active hepatitis B virus or hepatitis C virus infection. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study.
Acalabrutinib in Patients With Chronic Lymphocytic Leukemia With Direct Oral Anticoagulation (CICERO)

The goal of CICERO is to investigate the clinical outcome with a particular focus on prospective data on safety using acalabrutinib (+/- obinutuzumab) in CLL patients receiving co-medication with DOACs (edoxaban, rivaroxaban, dabigatran, apixaban) irrespective of treatment line.

The non-interventional study (NIS) CICERO will collect real-world data to explore acalabrutinib (+/- obinutuzumab) in adult CLL patients (irrespective of treatment line) who receive co-medication with DOACs. The primary focus of the study is to investigate the incidence proportion of bleeding events. Due to the mostly elderly CLL patient population, CLL patients often suffer from multiple cardiovascular comorbidities including atrial fibrillation (AF), deep vein thrombosis (DVT) or pulmonary embolism (PE) which make anticoagulation mandatory.

Up to now, no systematic and prospective evaluation on interactions of BTKis and DOACs has been conducted.

In Order to assess bleeding events, a questionnaire will be used to document if bleeding events occurred in-between visits in routine care. Patients will be asked at each visit if distinct events occurred in the time between the last visit until the current visit and discuss the questionnaire with the physician to determine of any (S)AE occurred until end of acalabrutinib treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients with chronic lymphocytic leukemia (CLL) and decision for treatment with acalabrutinib (+/- obinutuzumab) according to current SmPC as assessed by the treating physician or already started treatment with acalabrutinib (+/- obinutuzumab) according to current SmPC no longer than 6 weeks ago
* Other concomitant disease resulting in medical need of or already under treatment with direct oral anticoagulant (DOAC) treatment with edoxaban (Lixiana®) or rivaroxaban (Xarelto®) or dabigatran (Pradaxa®) or apixaban (Eliquis®) according to the respective current SmPC.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Signed, written informed consent.

Exclusion Criteria:

* Combination of acalabrutinib with other substances than obinutuzumab for CLL treatment
* Participation in an interventional clinical trial with acalabrutinib
Early Detection of Cardiac Damage With CMR in Women With Breast Cancer

With this study the investigators will assess early cardiac damage by means of Global Longitudinal Strain (GLS) in newly diagnosed breast cancer (BC) patients treated with anthracycline-based chemotherapy, and to investigate whether myocardial damage as measured with T1 / T2 Cardiovascular Magnetic Resonance (CMR) mapping and plasma hs-Troponin T is related to changes in GLS.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥ 18 years
* A diagnosis of primary breast cancer
* Starting (neo-) adjuvant chemotherapy treatment within 2 months after screening
* Cardiotoxicity risk score of intermediate, high or very high risk

Exclusion Criteria:

* Previous radiotherapy or systemic cancer treatment
* Cancer metastasis
* Life expectancy of less than 6 months
* History of myocardial infarction or heart failure
* Known contra-indications for CMR
* Refusal or inability to provide informed consent
Antibiotic Study for Dental Implants

This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

At Visit 1, the dentist will:

* do an oral exam
* ask some questions
* decide if the person qualifies for being in the study
* make an appointment for Visit 2 if they qualify

At Visit 2 (Baseline), the dentist will:

* do a special cleaning of the implants
* examine the whole mouth
* collect some fluid
* take x-rays
* put the people into one of two groups (taking into account whether or not they smoke)

  1. one group will have the study antibiotic put on all the areas in their mouth with gum problems
  2. the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.

At Visit 4 (about 3 months later), the dentist will:

* collect fluid samples
* examine the whole mouth
* apply the antibiotic again for people in that group

At Visit 5 (about 6 months later), the dentist will:

* collect fluid samples
* examine the whole mouth
* take x-rays

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age and good general health
* appropriately documented Informed Consent
* willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol
* female subjects must meet the pregnancy and contraceptive requirements
* must have oral health appropriate for study inclusion

Exclusion Criteria:

* oral health inappropriate for study inclusion
* females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
* reporting any of the following conditions:
* allergy to a tetracycline-class drug
* systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
* active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
* diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
* participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
* employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
* anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results
Sinomenine Versus Glucocorticoid for Knee OA

Both glucocorticoid and sinomenine are widely used in the routine clinical treatment of osteoarthritis, but there is still a lack of high level of clinical evidence for the direct comparison of efficacy between the two drugs. This trial aims to evaluate whether intraarticular injection of sinomenine was noninferior to intraarticular injection of glucocorticoid for symptom relief in patients with early knee arthritis, and whether intraarticular injection of sinomenine was superior to intraarticular injection of glucocorticoid for changes in tibial cartilage volume (measured by mean thickness) from baseline compared with intraarticular injection of glucocorticoid. 326 people will participate in the study at 3 different research/medical institutions, with centres competing for inclusion. This trial was designed by random blind method. This trial will last for 2 years and participants will receive 6 injections every 4 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 40 and \<70.
2. Bilateral knee pain lasting for more than 6 months and most of the last month;
3. X-rays showed that Kellgren and Lawrence had grade 2 or 3 knee osteoarthritis.

Exclusion Criteria:

1. Kellgren and Lawrence Level 1 or 4.
2. Radiographs showed that the reduction of the lateral joint space was greater than or equal to the medial joint space.
3. The affected knee had been injected with glucocorticoid or hyaluronic acid within the past 6 months.
4. Have had knee surgery or plan to have joint surgery on the affected knee.
5. Other medical conditions such as: systemic or inflammatory joint diseases (rheumatoid arthritis), history of crystalline or neurological joints, other muscular, joint or nervous system diseases affecting lower limb function.
6. Have a needle phobia.
7. Immunosuppression or acute infection is present.
8. Patients are allergic to the drugs involved in the study.
9. Have or have had cancer or tumours.
10. Have a hemorrhagic disease or are receiving anticoagulant or antiplatelet therapy.
11. History of hyperlipidemia, or plasma total cholesterol ≥6.2mmol/L and triglycerides \>2.3mmol/L
12. Have any other medical conditions that do not participate in the study, including contraindications to MRI, such as pacemakers.
13. Pregnancy.
14. Body mass Index (BMI) \> 40 kg/m2.
15. Unable to attend all study appointments within 24 months;
16. Inability to understand written and spoken Chinese.
17. Any history of mental and psychological illness.
Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.

In the latest guidelines for abdominal wall closure in emergency surgery published in the World Journal of Emergency Surgery (WJES) in 2023, no specific recommendations are made in this regard.

Current literature does not provide any articles comparing these two types of mesh materials (PP vs PVDF) in emergency colorectal surgery. It is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. This study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain.

It is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential subsequent complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy.
* Patients undergoing urgent laparoscopic surgery but requiring conversion to midline laparotomy.
* Need for urgent surgical treatment involving the colon and/or rectum, even in the presence of other abdominal pathologies.
* Age over 18 years.
* Signed informed consent (IC) from both the patient and the investigator
* Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
* BMI ≥ 35 kg/m2.
* Re-laparotomies.

Exclusion Criteria:

* Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent.
* Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).