cyrilzakka/clinical-trials huggingface dataset:
CardioInsight 2 - Non-responder

Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. However, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to CRT. Purpose of the clinical investigation. The purpose of the Electrical Activation Guided CRT for Nonresponders Study is to study the effectiveness of an addition of Hisbundle pacing approach to CRT nonresponder by direct His-bundle pacing to improve the responder rate of nonresponder of conventional CRT and a tailored made approach to CRT procedure by using a noninvasive globally mapping system studying the electrical conduction under different approaches to delivery CRT. The pacing approach that optimally corrects conduction abnormality will be determined before the actual addition of new lead procedure.

Conduct of the Investigation This study will include 18 patients already implanted with device delivering conventional CRT that known to have no response to the conventional CRT after 6 months of the CRT therapy from Prince of Wales Hospital, Hong Kong. You will be followed in the device clinic as per usual care after your participation in the study is completed.


Eligibility Criteria:
Inclusion Criteria:

* Adult (aged 18 or above) of both sexes
* Ischemic or non-ischemic cause of heart failure
* QRS duration \> 120 ms, non -LBBB type of conduction disturbance
* NYHA class III or above
* Informed consent by the patient
* Already received stable dose of guideline directed medical therapy for at least 3 months

Exclusion Criteria:

* LBBB patients
* Pregnant women
* Participation in another study
* Patient with contraindication to left ventricle catheterization by a retrograde aortic approach
HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma

This is a single center, single arm, phase II, prospective study to evaluate the safety and effectiveness of HAIC combined with TAE plus an ICI and an TKI in adult patients (aged ≥18 years) with unresectable intrahepatic cholangiocarcinoma.

Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of increasing local drug concentration and reducing systemic toxic and side effects. All patients were treated with HAIC (Oxaliplatin and Raltitrexed ). Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time； Tislelizumab was given 200mg every 3 weeks. The treatment continued until the patient developed the disease or met the other criteria for terminating the study.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent for the trial.
2. Aged ≥18 years.
3. Histologically confirmed intrahepatic cholangiocarcinoma.
4. No other previous systematic treatment for BTC.
5. At least one measurable lesion (RECIST 1.1).
6. Eastern Cooperative Oncology Group performance status 0 or 1.
7. Life expectancy of 3 months or greater.
8. Child-Pugh classification score ≤7.

Exclusion Criteria:

1. Recurrent patients.
2. Eastern Cooperative Oncology Group performance status ≥ 2.
3. Life expectancy of less than 3 months.
4. Child-Pugh classification score \> 8.
5. History of hepatic encephalopathy or liver transplantation.
6. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
7. Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage.
8. Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus.
9. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-CTLA4, etc.).
10. History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
11. The researcher considers it inappropriate to enter this study.
Foot Perfusion Analysis to Predict Limb Salvage

This study aims at evaluating the correlation between foot perfusion on angiographies performed before and after revascularization and limb salvage in patients with critical limb ischemia.

Critical limb ischemia (CLI) in diabetic patients is increasing drastically worldwide, and is already recognized as a major health issue. CLI is frequently leading to major amputations. Therefore, one of the key point to prevent limb loss is to restore a good vascularization to the foot, usually thanks to endovascular means.

No consensual indicator is currently available to estimate if the limb revascularization will be sufficient or not to prevent amputation, and to help physicians decide if they should be more aggressive during the endovascular procedure. Transcutaneous oximetry and value of the ankle-brachial index (ABI) are commonly used in the ward (not available in the operating room), but have shown poor correlation to wound healing or limb salvage and results are frequently biased because of the arterial wall calcifications due to diabetes. Value of the first toe systolic pressure is currently under evaluation to predict survival without amputation, with promising results, but cannot be applied to patients with wounds at this level or previous minor amputation.

The emergence of hybrid rooms in the operating theater offer access to high quality imaging and image post-treatment. Those capabilities could be used to analyze the flow and the tissue perfusion in the foot, and correlate those imaging parameters to positive clinical outcomes, such as wound healing, thus creating a useful tool to guide physicians in daily practice.

Differences between foot angiographies performed before and after revascularization could be used to estimate the quality of the revascularization and predict wound healing and limb salvage. This method would be directly available in the operating room and could help physicians to optimize their strategy during the procedure

Eligibility Criteria:
Inclusion Criteria:

* Patients with critical limb ischemia Rutherford 4, 5 and 6, with at least one pre-operative exam (CTA, magnetic resonance angiography or ultrasound) demonstrating a peripheral arterial disease, and requiring an endovascular or hybrid (meaning combined with a surgical technique) revascularization of the lower limb.

Exclusion Criteria:

* Patients not willing to give their consent to study enrollment
* Patients under 18 years old
* Patients with severe renal insufficiency (estimated creatinine clearance \< 30 mL/min), without dialysis
* Patients with life threatening septic wounds who would require an amputation at the initial presentation
Changes Of Sleep on the Sensoriomotor and Cytokine In Patients With Osteoarthritis

Osteoarthritis (OA) is one of the major health problems and their prevalence has increased in recent decades. It has been shown that OA causes negative effects on sleep and that these changes in sleep see to be correlated with the function and physical performance of patients with OA. However, no study to date has demonstrated the effects of sleep changes in sensorimotor control and systemic inflammatory response in patients with OA. The objective of this study is to assess the influence of sleep changes in sensorimotor control (postural and neuromuscular control) and inflammatory markers (cytokines) in patients with knee OA grade I or II. Participate in this study, 60 male volunteers, aged between 40 and 65. These volunteers will be divided into four groups: Group 1 (n = 15): Osteoarthritis and good quality sleep, Group 2 (n = 15): Osteoarthritis and poor quality sleep, Group 3 (n = 15): Without good and Osteoarthritis quality of sleep, Group 4 (n = 15): Without Osteoarthritis and poor quality of sleep. All volunteers will perform a polysomnography to detect the presence or not of changes in sleep. Further testing on the isokinetic dynamometer to evaluate the acceleration time, maximum isometric torque and isokinetic concentric and eccentric maximum quadriceps muscle strength and a submaximal test to evaluate neuromuscular control. Also there will be a test on the force platform to assess the uni-and bipedal postural control, as well as respond to the WOMAC questionnaire that assesses the quality of life in patients with OA. Blood will be collected for analysis of inflammatory cytokines (TNF-alpha, IL-1alpha, IL-1beta, IL-6, IL-8, IL-12, IL-10, TGF-beta). The significance level is 5% (p ≤ 0.05).

The experimental design of each volunteer (all groups) will be evaluated by a physician before beginning the study and posteriomente will perform a polysomnography. The day after polysomnography voluntary blood will be collected. A week after the volunteer will perform the balance test (force platform) and the test of strength (isokinetic).

Eligibility Criteria:
Inclusion Criteria:

* with and without osteoartrhitis
* no other health problems
* sedentary

Exclusion Criteria:

- other clinical and neurobiological conditions
Combination of the Vaginal Laser With a Moisturizing and Repairing Niosomal Gel in the Treatment of Genitourinary Syndrome in Oncology Patients

Vaginal laser together with the use of moisturizing and repairing gels could be an effective therapy for the treatment of genitourinary syndrome in women with a history of neoplasia in whom the use of estrogens is not recommended.

The purpose of this study is to evaluate the effectiveness of vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an established SGM diagnosis.
* Patients with a history of neoplasia in whom the use of estrogens as the first alternative for the treatment of GMS is not recommended.

Exclusion Criteria:

* Patients with concomitant vulvovaginal pathology.
* Patients with a diagnosis of pelvic organ prolapse grade II or greater.
Vitamin D Supplementation in Pediatrics. Oral or Parenteral! D2 or D3

A study will be performed on Vitamin D deficient/ insufficient Egyptian children to compare the efficacy of oral and parenteral forms of Ergocalciferol and cholecalciferol in raising serum 25(OH) D levels in these subjects


Eligibility Criteria:
Inclusion Criteria:

* laboratory evidence of vitamin D deficiency or insufficiency without clinical signs of rickets

Exclusion Criteria:

* vitamin D or calcium supplementation within the last 6 months before inclusion, patients with diabetes mellitus, chronic liver disease and kidney disease, congenital or rheumatic heart disease, malabsorption syndromes, thyroid disease, juvenile rheumatic diseases, or other bone disorders.
Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation

Prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating supraglottic airway. Video will be collected during resuscitation as well as written documentation. Primary outcome will be time to spontaneous breathing, length of resuscitation, and need for endotracheal intubation.

Mothers who are close to delivery of a term or near term infant with estimated fetal weight of 2500gms will be approached for consent to randomize their infant to resuscitation with mask or non-inflatable supraglottic airway (NISGA) if resuscitation is required. Study personnel in delivery will open sequential envelopes with randomized code to indicate which device is to be used if necessary. The resuscitator will be blinded until determination of need of respiratory support. At that time, the appropriate randomized device (face mask or NISGA) will be handed to the resuscitator for use along with T-Piece resuscitator. Video data capture will be used to record type, length and response to resuscitation. This information will be translated to a database prior to destruction of video.

Eligibility Criteria:
Inclusion Criteria:

* Newborns \> or = 2000gms requiring positive pressure ventilation within the first 2 minutes of life

Exclusion Criteria:

* Newborns with expected fetal weight \<2000 grams
* Known congenital malformations
* Multiple gestation (twins and above)
* History of meconium stained fluid
Simplified Severe Sepsis Protocol-2 (SSSP-2) in Zambia

This study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis with hypotension in Zambia. This is a follow-up study to the Simplified Severe Sepsis Protocol (SSSP) study. The intervention protocol consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. It is hypothesized that the protocol will significantly decrease in-hospital mortality in patients with severe sepsis and hypotension.

In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. In sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Studies of fluid interventions in the region, however, have demonstrated conflicting results. Outcomes in septic patients may be further affected by delays in the diagnosis of tuberculosis-associated severe sepsis.

The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis with hypotensionor septic shock, (2) To evaluate the cost of implementation for a simplified severe sepsis protocol, (3) To develop a clinical diagnostic score for identifying tuberculosis in HIV positive patients with severe sepsis, and (4) To assess the performance of the Xpert TB/RIF rapid PCR system and urine lipoarabinomannan assay for diagnosing tuberculosis in HIV positive patients with severe sepsis.

Eligibility Criteria:
Inclusion Criteria:

* infection suspected by the treating physician
* 2 or more of the following SIRS criteria:
* - Heart rate \>90/min
* Respiratory rate \>20/min
* - Temperature ≥ 38° C or \< 36° C
* White blood count \> 12,000 or \< 4,000/µL
* 1 of the following:
* Systolic blood pressure (SBP) ≤ 90 mm Hg
* Mean arterial blood pressure (MAP) ≤ 65 mm Hg

Exclusion Criteria:

* Gastrointestinal bleed in the absence of fever
* Need for immediate surgery
* Respiratory rate greater than 40/min with oxygen saturation less than 90%
* Suspected congestive heart failure exacerbation
* End-stage renal disease
* Raised jugular venous pressure (JVP) at baseline
* Currently incarcerated
Intervention for Postpartum Infections Following Caesarean Section

The purpose of this study is to examine whether Negative Pressure Wound Therapy is an effective wound treatment compared to conventional wound treatment in the period of time from reoperation to re-suturing in women having surgical wound rupture after Caesarean Section.

This study is a non-blinded randomized controlled trial and a concurrent Health Economic. The study examines the effect on wound healing using NPWT compared with conventional wound treatment in women, who experience spontaneous dehiscence or where a surgeon deliberately opens the wound after Caesarean Section (CS).

Women, who have given informed consent, will be randomized to either intervention or control group via a computer-generated randomization program. It is not possible to blind either participants or therapists. The analysis will be carried out on an intention to treat basis.

Women with post-CS wound infection will be hospitalized and the wound will be reopened and cleaned under general anaesthesia. In the intervention group women will be treated with NPWT. The change of wound dressing on the second day takes place in the obstetrical or plastic surgery ward. On the fourth day, the NPWT material will be removed and the wound evaluated before re-suturing. In the control group the wound will be treated with a hydrofiber or alginate dressing. Changes of wound dressing will take place on the second and fourth days as in the intervention group. In both groups, when the wound is evaluated on the second and fourth day, it will be described and measured (depth, width, length). After four days of treatment, the wound will be re-sutured in both groups. It is expected that some wounds are not suitable for re-suturing on the fourth day. If a woman does not want to participate, she will receive the conventional treatment, which corresponds to the treatment in the control group. Women, who do not wish to participate, will be asked for permission to use their data in the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year
* Women, who can read and understand Danish

Exclusion Criteria:

* Serious illness requiring medical treatment, such as cancer
* Stillborn child
* If the fascia is ruptured
Effectiveness of Ziprasidone for Patients With Schizophrenia

This study is designed with the aim to evaluate the clinical effect of the overlapped switching to ziprasidone as well as the efficacy and safe metabolic profile of ziprasidone.

Patients with schizophrenia or schizoaffective disorder were recruited in this 12-week, multicenter, non-comparative, open-label trial. Prior antipsychotics were allowed to be maintained for up to 4 weeks during the titration of ziprasidone. Efficacy was primarily measured using the 18-item Brief Psychotic Rating Scale (BPRS) at baseline, 4 weeks, 8 weeks, and 12 weeks. Efficacy was secondarily measured by the Clinical Global Impression - Severity (CGI-S) scale and the Global Assessment of Functioning (GAF) scale at each visit. Regarding the metabolic effects of switching to ziprasidone, weight, body mass index (BMI), waist-to-hip ratio (WHR), and lipid profile-including triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol levels-were measured at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 18-55 years treated with risperidone, olanzapine, amisulpride, quetiapine and typical antipsychotics.
* Both in- and outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia or schizoaffective disorder.
* Their primary psychiatric clinician determined that they would benefit from a change in their medications, either because of suboptimal efficacy or because of side effects.

Exclusion Criteria:

* Those who are treated with medications that prolong the QTc interval.
* Those who have any other axis I DSM-IV diagnoses.
* Those who have a history of substance abuse or dependence within 1 month.
* Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results.
* Those who have a past history of hypersensitivity or intolerance to ziprasidone.
* Those who have history of clozapine use within 1 month.
* Those who participated in clinical trials within 1 month before entering the study entry.
* Those who have used depot antipsychotics within one cycle before entering the study.
* Those who are pregnant or are breast feeding.
* Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study.
* The patients unable/unlikely to comprehend/follow the protocol.
Compassionate Use of Stanate (TM) [Stannsoporfin]

The purpose of this protocol is to make Stanate (TM) \[stannsoporfin, tin-mesoporphyrin\] available to infants who meet the following criteria:

1. the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
2. the infant requires an exchange transfusion; and
3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.


Eligibility Criteria:
* Term or near term neonate
* Elevated serum bilirubin
* Failing phototherapy
* Requires exchange transfusion
* Family refuses exchange transfusion on religious grounds
WaveLight® EX500 Excimer Laser System for the Correction of Myopia Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap

The purpose of this study is to evaluate the safety and effectiveness of the WaveLight EX500 excimer laser system for the correction of myopia with and without astigmatism using InnovEyes in conjunction with InnovEyes sightmap.

Qualified subjects will receive treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Day 0 Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Year 1). The primary endpoints will be assessed at refractive stability, defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. Total expected duration of subject participation is approximately 1 year. This study will be conducted in the United States.

Eligibility Criteria:
Key Inclusion Criteria:

* Myopia up to and including -11.00 D with or without astigmatism up to -4.50 D, with MRSE no more than -12.00 D
* Best corrected photopic distance visual acuity of 20/20 or better
* Uncorrected photopic distance visual acuity of 20/40 or worse
* Stable refraction (within ± 0.50 D) as determined by MRSE for a minimum of 12 months prior to surgery

Key Exclusion Criteria:

* History or evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma (or suspect)
* Previous intraocular or corneal surgery
* Intent to have monovision treatment

Other protocol-specified inclusion and exclusion criteria may apply.
Serum Prostatic Specific Antigen Changes After Bipolar and Monopolar TURP

To use PSA levels after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia as an indicator of the quality of resection .

PSA is a protein produced from the prostate epithelium and secreted in semen in huge amounts , small amount find its way to the circulation ,its function is to allow mobility of the sperms by interacting with the Semenogelin . clinical BPH can be defined as prostate adenoma/adenomata, causing a varying degree of BOO, which may eventually cause harm to the patients ,Treatment of this condition varies from conservative, medical and surgical depending on factors related to the patient and the surgeon preference . The early reports of minimally invasive treatment of the prostate dated back to 1937, since then and remarkable development is noticed . TURP is the golden treatment in the BPH . Studies compare between the methods according the blood transfusion , operation time retention after catheter removal , urethral complications , TUR syndrome and hospital-stay which show that bipolar is better. To our knowledge after few studies compare between the techniques according PSA also these studies show weakness in their statistically analysis with no difference between the methods .investigators aim is to study the effect of the operations on PSA levels as an indicator of the quality of resection.

Eligibility Criteria:
Inclusion Criteria:

* Patients agreeing to participate, clinically fit, age from 50 to 80 years with LUTS related to benign prostate enlargement with no neurological disorder

Exclusion Criteria:

* Prostate cancer
* Previous urethral or prostate surgery
* Neurogenic bladder
* Urethral stricture
* Patient unfit for surgery