cyrilzakka/clinical-trials huggingface dataset:
Risk Factors of Delirium in Sequential Sedation Patients in Intensive Care Unit

Delirium is one of main adverse events in ventilated patients who receive long-term usage of mono-sedative. Sequential sedation may reduce these adverse effects. This study aimed to evaluate incidence and risk factors for delirium in sequential sedation patients.

Previous studies have showed that patients under mechanical ventilation have a higher risk for experiencing delirium than nonmechanically ventilated patients (20%-50%). Its occurrence is also more frequent in elder patients. More than that, it is often hard to identify delirium by physicians, leading to unreasonable management of ICU patients.

And delirium is one of main adverse events in ventilated patients who receive long-term usage of mono-sedative. Sequential sedation may reduce these adverse effects.

However, few present studies focus on delirium in sequential sedation patients. Thus, in this study, we aimed to determine the factors of delirium in patients who received sequential sedation in ICU.

Eligibility Criteria:
Inclusion Criteria:

1. Intubated patients;
2. Age≥18 years old;
3. Anticipated Ventilation and sedation duration of at least 72 hours.

Exclusion Criteria:

1. Allergy to the study drug;
2. suspected pregnancy;
3. gross obesity;
4. Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite plasma volume expansion and continuous infusions of vasopressors before the start of study drug infusion;
5. Uncontrolled abnormal hypertension, such as systolic blood pressure more than 180 mmHg or diastolic more than105 mmHg;
6. Heart rate less than 50 bpm;
7. Second or third degree heart block;
8. moribund state;
9. history of alcoholism or intake of anti-anxiety drugs or hypnotics;
10. chronic renal failure;
11. coma by cranial trauma or neurosurgery or unknown etiology or epileptic state;
12. History of neuromuscular disease;
13. unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission.
Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme

The objective of this study is to assess the efficacy and safety of TLN-4601 used to treat patients with Glioblastoma Multiforme(GBM) that recur/progress after receiving first line systemic therapy post surgery/radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Glioblastoma Multiforme (GBM)
* Prior treatment with radiation and one first line systemic therapy (including temozolomide or other chemotherapy, immunotherapy, targeted therapy or combination therapies), followed by measurable and unequivocal evidence of tumor progression or recurrence
* Age ≥ 18 years
* ECOG ≤ 2
* Normal organ and marrow function as defined below:

  * leukocytes ≥3 x 109/L
  * absolute neutrophil count ≥1.5 x 109/L
  * platelets ≥100 x 109/L
  * hemoglobin ≥90 g/L
  * total bilirubin ≤2.5 X institutional upper limit of normal
  * AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
  * creatinine ≤1.0 X institutional upper limit of normal

Exclusion Criteria:

* Patients with a life expectancy \< 12 weeks
* Patients with a documented history of HIV, active hepatitis B or C infections
* Female patients who are pregnant or lactating
* Patients in whom a proper central line (Portacath-like device) cannot be established
* Patients with a known hypersensitivity to farnesylated dibenzodiazepinone or polysorbate 80
* Patients with uncontrolled hypotension
* Patients with concomitant therapy of therapeutic coumadin
Operational Research for Cryptococcal Antigen Screening

This will be a stepped wedge randomized trial design to evaluate the implementation of cryptococcal antigen (CRAG) screening and preemptive anti-fungal therapy of HIV-infected persons entering antiretroviral therapy (ART) outpatient treatment in Uganda. Those who are ART eligible with a CD4≤100 cells/mcL will have a serum/plasma CRAG performed by lateral flow assay. Those who are CRAG-positive and asymptomatic will be treated with high dose fluconazole. After 6 months survival with retention-in-care will be compared between those who are CRAG+ and CRAG negative


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* CD4≤100 cells/mcL
* Cryptococcal antigen (CRAG) positive
* age \>14 years

Exclusion Criteria:

* Suspected Cryptococcal meningitis
* Prior known history of cryptococcal meningitis
* currently receiving HIV antiretroviral therapy
* Allergy to any azole antifungal medication
* Persons with known serious hepatic co-morbidities, transaminitis, or clinical jaundice who should not receive fluconazole in the opinion of the study investigator.
* Current known pregnancy
Egg Intervention During Pregnancy in Indonesia

The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old

The study aims to assess the impact of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes in infants. The open-label intervention study would be conducted alongside the observational study in the same study setting by recruitment of additional number (n=153) of pregnant women. Thus, a total of 653 pregnant women would be enrolled in the study; 153 women would be randomized to intervention arm and 500 to the control arm who would form an observational cohort of women and newborns as described above. The intervention group women will be provided one egg three times per week from recruitment (2nd trimester) until term. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives or Public Health Centre (IFA tablet, calcium tablet, nutrition counselling).

Eligibility Criteria:
Inclusion Criteria:

* Woman is between 16 and 20 weeks of pregnancy based on the date of the first day of her last menstrual period.
* She is 18-40 years of age.
* She is planning to remain in the study area over the next 30 months.
* She is of Sasak ethnicity

Exclusion Criteria:

* She is expecting multiple births.
* She has a known egg allergy.
ProViS (Prolift+M and Vita Sexualis) Study

Transvaginal meshes (TVM) are indicated for the treatment of pelvic organ prolapse (POP) where surgical intervention is necessary. Due to a potential risk of de novo dyspareunia, TVM are mainly used in postmenopausal women and in case of recurrent POP. PROLIFT+M (Trademark) is based on a highly flexible material which is partially absorbable. We suggest that PROLIFT+M has less impact on the vita sexualis than conventional TVM and could also be used for the treatment of younger and/or sexually active women. This study observes women who are routinely treated with PROLIFT+M with regard to their sexual function before and after the surgery. The hypothesis is that there is no worsening in vita sexualis with PROLIFT+M.


Eligibility Criteria:
Inclusion Criteria:

* The patient understands the nature and content of the trial
* POP ≥ stage II (according to the POP-Q system (18))
* Sexual intercourse ≥ 2x/4 weeks
* Written informed consent
* Negative pregnancy test in women of childbearing potential
* Women ≥ 18 years

Exclusion Criteria:

* Concomitant surgery at the inner genitalis (e.g. colporrhaphy, sacrocolpopexy, sacrospinous fixation, hysterectomy); concomitant suburethral slings and bulking agents are allowed
* Unable to read or speak German
* Women \< 18 years
* Women who are pregnant or breastfeeding or planning future pregnancies
* Acute infection(s), e.g. untreated urogenital infections
BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty

The goal of this study is to compare the anesthetic combination iPACK with femoral triangle block versus surgical LIA for unilateral TKA. We hypothesize that an iPACK block with femoral triangle block is non-inferior to surgical LIA. Furthermore, due to visualization of the relevant neural and vascular structures, the risk of accidental popliteal block, nerve damage or LAST with (a blindly performed) LIA could theoretically be reduced.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* BMI 17-35 kg/m2
* Patient is able to give informed consent
* Patient is scheduled for TKA

Exclusion Criteria:

* Refusal of patient
* Inability to communicate due to language or neurologic barriers
* Bilateral TKA or unilateral knee arthroplasty
* Chronic opioid use (including partial opioid agonists) + chronic pain patients:
* Use of atypical analgesics (gabapentin, pregabalin, ...)
* History of Sudeck atrophy
* History of \>3 chronic pain consultations
* Contraindications for spinal anesthesia
* Patient refusal
* Local infection
* Aberrant coagulation (according to the latest ESRA guidelines)
* Severe spinal canal stenosis
* Intracranial hypertension
* History of neurological injury in the affected limb
* Contraindications for local anesthetics
* Allergy for local anesthetics
* Absolute contraindications for NSAIDs or paracetamol
* Proven allergy for NSAID's (including ASA syndrome) or paracetamol
* Severe renal function impairment (eGFR \<30 ml/min/1.73 m2)
* Active or recent (\<6 months) history of gastric ulcera/perforations/bleeding
* Crohn disease or colitis ulcerosa
* Liver function impairment or severe renal function impairment (eGFR \<30 ml/min/1.73 m2)
* Pregnancy or breast-feeding
Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men

The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. The secondary aim of this study is to assess the influence of the treatment with Levitra on self-esteem (depressive symptomology) in men with ED.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Erectile dysfunction untreated or ineffectively treated with other than vardenafil PDE5 inhibitors

Exclusion Criteria:

* Treatment with nitrates
* Allergy to vardenafil or other tablets ingredients
* Treatment with CYP3A4 inhibitors (e.g. indinavir, ritonavir, ketoconazole, itraconazole, erythromycin)
* Cardiovascular status excluding any sexual activity
Clinical and Microbiological Comparison of 0.12% CHX and 0.05% CHX+0.05%CPC Mouthwashes in TPS Patients

The present study compares the effectiveness of two mouthwash formulations (0.12% CHX and 0.05% CHX+0.05%CPC) in reducing gingival inflammation and microbial colonization in individuals with gingivitis and in preventing periodontitis recurrence. The main focus is on assessing the clinical impact of the mouthwashes over six months, with a secondary goal of evaluating their effect on systemic blood pressure.

This study aims to assess the impact of at-home use of 0.05% CPC + 0.05% chlorhexidine or 0.12% chlorhexidine, combined with professional plaque removal, on gingival inflammation and microbial quantity and quality in individuals diagnosed with gingivitis and reduced periodontium. It seeks to identify the most effective mouthwash formulation for reducing microbial colonization and preventing periodontitis recurrence. Comparing the commonly used 0.12% chlorhexidine with the alternative formulation of 0.05% chlorhexidine + 0.05% CPC over one month, with no reported side effects, is the main focus. The study does not pose risks to participants, with the main inconvenience being tooth enamel darkening, which can be easily resolved with professional dental cleaning. The primary objective is to evaluate the additional clinical effect of both formulations after professional plaque removal over six months in patients undergoing supportive periodontal therapy. The secondary objective is to assess the impact of these antimicrobials on systemic blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Bleeding on probing (BOP) ≥10%,
* No more than 4 sites with pocket depth (PPD) \>5mm
* Presence of attachment loss (AL) and radiographic bone loss (RBL)
* A minimum of 20 teeth

Exclusion Criteria:

* Intolerance or allergy to antimicrobials
* Systemic therapy with anticoagulants/beta-blockers
* Local/systemic antibiotic therapy 3 months before
* Inability to understand and sign the written informed consent
A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers

This single center, open-label, non-randomized, one-treatment, one-period study will evaluate the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in male healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, 45 to 65 years of age inclusive
* Body mass index (BMI) between 18 and 32 kg/m2 inclusive

Exclusion Criteria:

* Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the subject
* Clinically significant abnormal laboratory values
* Infrequent bowel movements (e.g. less than one movement per 24 h on average)
* An intent to father children within 3 months of dosing
* Any external or internal radiotherapy with open (nuclear medicine) or sealed sources (brachy therapy)
* External irradiation (radiological examination) or internal radiation (diagnostic nuclear medicine procedure) within one year before study drug dosing; dental radiography and plain X-rays of the extremities are allowed before dosing
Prevention of Post Operative Bone Loss in Children

Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density

Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or saline. Repeat DXA scan will determine bone lost after end of immobilization or nonweightbearing.

Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora

Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D

Following surgery of hip(s) or lower extremities, randomization into treatment with low dose IV pamidronate (one dose) v placebo group

Repeat DXA scan after end of immobilization or non-weightbearing

Eligibility Criteria:
Inclusion Criteria:

* chronic condition predisposing to low bone density, such as cerebral palsy, osteogenesis imperfecta
* lower extremity surgery proposed that will require post op nonweightbearing, casted or not, for a minimum of 4 weeks

Exclusion Criteria:

* creatinine \>1.2
* prior bisphosphonate exposure
* orthopaedic implants in distal femoral precluding DXA scan
* inability to cooperate with DXA scan
Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue

The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on retinal and choroidal ocular tissue.

The study objectives are to:

1. assess the changes from pre- to post- oral supplementation on retinal and choroidal thickness and blood flow, retinal oxygen saturation, ocular perfusion pressure, and retinal function

Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 - 55 years, inclusive
* Good general and ocular health
* Corrected visual acuity of 20/40 or better
* No gingko biloba supplementation within the last 3 months

Exclusion Criteria:

* All significant ocular and any systemic disorders considered likely to affect the systemic or ocular vasculature
* History of ocular surgery, including refractive surgery
* Use of ocular medications
* Conditions where ginkgo supplementation is contraindicated
* Any eye or systemic disease that affect vision or refractive error
* Current smokers
* Subjects who are pregnant, breastfeeding, or planning conception
Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery

The purpose of this study is to compare the analgesic profile of modified pectoral nerves block and serratus plane block in patients undergoing mastectomy.

This study includes three groups. The first group will receive ultrasound-guided modified pectoral nerves block prior to induction of general anesthesia. The second one will receive ultrasound-guided serratus plane block prior to induction of general anesthesia. The third one will not receive any block preoperatively.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists( ASA) I or II and scheduled for major breast cancer surgery( modified radical mastectomy or conservative mastectomy with axillary evacuation).

Exclusion Criteria:

* Local infection at the site of the block, coagulations abnormalities, allergy to local anesthetics or morphine, body mass index\> 35, patient refusal, severe respiratory or cardiac disorders, pre-existing neurological deficits, hepatic or renal insufficiency, chronic pain syndrome, chronic analgesic use and psychiatric disorders.
Maintaining Independence in Everyday Life Among Seniors With Subjective Cognitive Complaints

The purpose of this study is to determine the effectiveness of cognitive strategies in improving participation in daily activities within older adults who report subjective cognitive decline.

The planned project explores the effects of several interventions designed to promote independence in everyday life, with older adults who identify cognitive complaints. Evidence suggests that 25-50% of community dwelling older adults report cognitive difficulties, such as reduced memory or concentration, in the absence of any diagnosed condition. Cognitive skills are crucial to living independently. The investigators plan to examine two approaches in a randomized controlled trial. Based on our successful pilot study, the investigators hypothesize that this training which combines education on healthy lifestyles and problem solving training to address everyday life difficulties, will be effective in maximizing and maintaining independence of older adults.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults aged 60+
* Fluent in written and spoken English
* Have subjective cognitive complaints (SCC)
* Performance within normal limits on a neuropsychological assessment battery
* Participants must also be able to self-identify specific areas of difficulty in their everyday life that they would like to improve

Exclusion Criteria:

* Significant neurological or psychiatric history (e.g., multiple sclerosis, psychiatric illness requiring hospitalization)
* Concurrent depression
* Anaesthesia in previous 6 months; and substance abuse
Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy

Loop formation is the most frequent cause of cecal intubation failure during colonoscopy. To reduce the loop formation, external abdominal pressure is widely used and proved to be helpful. Properly applied pressure can also decrease patients discomfort and shorten the cecal intubation time.

The loop formation during water exchange is less severe as compared with during air insufflation and can be reduced quite readily. Traditionally an assistant is not asked to administer abdominal compression until the endoscopist has struggled for some time and failed to reduce the loops by withdrawal. The colonoscopist can administer the abdominal compression whenever the scope is not advancing smoothly, probably in the early stage of loop formation. We test the hypothesis that colonoscopist administered abdominal compression to remove loops in their early stage of formation hastens cecal intubation.

A total of 120patients will be randomized in a 1:1 ratio (n=60 per group). When the tip of the scope doesn't advance or paradoxical movements occur, loop reduction by withdrawal of the scope will be implemented. If looping persists, abdominal compression will be applied. In the endoscopist-administered abdominal compression (endoscopist) group, the colonoscopist will apply the compression with his right hand and counter the pressure by pushing the back of the patient with his left forearm with the colonoscope in his left hand. The compression will be administered at left lower quadrant when the scope is in the sigmoid colon and at left lower quadrant and upper abdomen, respectively, when the scope tip reaches the transverse or ascending colon. If the formation of loop cannot be overcome, an assistant will apply the abdominal compression instead. In the assistant-administered abdominal compression (assistant) group, an endoscopic assistant will apply abdominal compression when a loop is formed. The assistant will apply the compression at the left lower quadrant initially, but quickly shift to other parts as needed depending on the tip location of colonoscope. If manual compressions fail, then the patients' position will be changed.


Eligibility Criteria:
Inclusion Criteria:

* In the Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.
* Patients who undergo WE colonoscopy performed by the two endoscopists (YHH and CWT) at the endoscopic suite will be included.

Exclusion Criteria:

* Included patient declined to give consent,
* age \<20 years old,
* age \>80 years old,
* previous partial colectomy, not completely consumed bowel prep regimen, massive ascites, or known colonic obstruction, morbid obesity (BMI ≥ 35).
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty

It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients.

PURPOSE:

1. To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects.
2. To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
* ASA I - III
* Spinal anesthesia
* All patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. A tourniquet will be used in all cases
* Male and Female over 18 who are willing and able to provide informed consent

Exclusion Criteria:

* Opioid use within 3 months preoperatively
* Inability to take the protocol medications
* Anticoagulant other than aspirin
* Contraindication to regional anesthesia
* Non-english speaking
* ASA IV or greater
* Psychiatric or cognitive disorders
* Allergy/contraindications to protocol medications.
* Renal insufficiency with Cr \> 2.0 or hepatic failure
* General anesthesia
* Sensory/motor disorder involving the operative limb