cyrilzakka/clinical-trials huggingface dataset:
Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.

It is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption.

Nasal septoplasty is a surgery procedure which needs to have decrease the bleeding during the surgery for the visibility of surgical site.And postoperative pain is very usual after the surgery, so an effective postoperative analgesia procedure reduces the complications and helps to be discharged earlier from the hospital. An alpha 2 agonist Dexmedetomidine has an analgesic effect and vasoconstructive effect on the periferal blood vessels. Our hypothesis was dexmedetomidine makes a better surgecal conditions during the surgery and reduce the postoperative analgesic consumption. We administered the infiltrated dexmedetomidine or lidocaine plus adrenaline to the both side of the nasal septum 10 minutes before the surgery. Bleeding scores (Fromm and Boezaart Bleeding Scores) were recorded during the surgery. And postoperative analgesic consumptions were recorded in first 24 hours after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for the nasal septoplasty surgery
* ASA 1-2 patients
* 18-60 yo patients

Exclusion Criteria:

* Pregnant patients
* ASA 3-4 patients
* Under 18 yo childrens
Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN)

The communication between the lungs and the brain has drawn a lot of attention recently. Animal studies have shown that the breathing cycle is coupled with brain activity, showing that the greater the volume of air delivered to the lungs via a breathing machine greater the brain activity and also the greater the injury to the brain cells.

There is no study in humans that investigates the physiological communication between the volume of air delivered to the lungs and brain activity. This is important because really sick patients receive breathing assistance using breathing machines to keep their oxygen levels within a normal range. Although these machines are life-saving tools, they might result in brain cell injury, leading to cognitive impairment. So, establishing the existence of a physiological communication between the volume of air delivered using these breathing machines and brain activity is the first step to investigating therapies to prevent brain cell injury due to the use of breathing machines to assist breathing.

Demonstration of a physiological relationship between tidal volume set on the ventilator and hippocampal activity measured as changes in blood-oxygenation level-dependent (BOLD) in the regions of interest (ROIs). The results from this pilot study might assist in creating the foundation for explaining the mechanism of action of ventilation-associated brain injury.

Mechanically ventilated patients who are undergoing MRI examinations under general anesthesia in isocapnic and isoxic conditions will have brain activity investigated under two different tidal volumes, 6 ml/kg and 12 ml/kg applied for 3-5 minutes. Positive end-expiratory pressure will be adjusted to maintain plateau pressure \<30 cm H2O.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled to undergo an MRI scan of their head under general anesthesia
2. Age \> 18 years

Exclusion Criteria:

1. Stroke, and/or brain tumor in the regions of interest that has not been diagnosed before the MRI scan
2. Previous medical history of dementia
3. Previous medical history of brain surgery
4. Acute or chronic spinal cord Injury
5. Previous Vagotomy
6. Phrenic nerve injury
A Research Study to Compare the Treatments of a Combination of Elzasonan With Zoloft, to Zoloft Alone, or Placebo in People With Major Depressive Disorder (MDD)

The major purpose of the study is to help determine whether giving the combination of Elzasonan with Zoloft to people with depression is a better treatment than taking Zoloft alone. This study will also compare the safety and tolerability of Elzasonan and Zoloft combination to Zoloft alone or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects, 18 years of age or older with a diagnosis of recurrent, moderate-to-severe MDD without psychotic features (DSM-IV 296.3x, with a HAMD17 score \>= to 22 and CGI-S \>=4.
* MDD must be the primary psychiatric disorder that motivated the subject to seek treatment and the current episode must be at least 1 month in duration but no longer than 6 months in duration.

Exclusion Criteria:

* Subjects who, in the investigator's judgement, would require treatment with electroconvulsive therapy (ECT), or antipsychotics, or would require a change in intensity of psychotherapy, or subjects who would require treatment with any other psychotherapeutic drugs during the course of the trial.
* Subjects who have ever been diagnosed with Panic Disorder, Post-Traumatic Stress Disorder, Obsessive-Compulsive Disorder, Bipolar Affective Disorder, Schizophrenia, Schizoaffective Disorder or othe Psychotic Disorder, MDD with a seasonal pattern, or Dissociative Disorders per DSM-IV criteria.
A Study of ARRY-520 in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-520.

This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 15 patients (per schedule) from the US will be enrolled in Part 1 (Completed).

In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15 patients from the US will be enrolled in Part 2 (Completed).


Eligibility Criteria:
Key Inclusion Criteria:

* Histological or cytological evidence of malignancy.
* Advanced solid tumors that have recurred or progressed following standard therapy(ies).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Adequate hematology counts and serum chemistry values.
* Additional criteria exist.

Key Exclusion Criteria:

* Treatment with an investigational product or device, or anti-neoplastic therapy (with the exclusion of hormone therapy where the therapy will continue at a standard dose throughout the study) within 28 days prior to the first dose of study drug.
* Major surgery within 28 days prior to the first dose of study drug.
* Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if local RT to \<5% of the bone marrow).
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
* Additional criteria exist.
Virtual Mom Power With High-Adversity Mothers and Children (MPHAMC)

This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention.

This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily intervention with previously demonstrated effectiveness improving maternal mental health and parenting stress in randomized controlled trials. vMP targets 5 core components: 1) enhancing social support; 2) attachment-based parenting education; 3) self-care, including affect regulation; 4) guided parent-child interactions, and 5) connecting to care. Eligible and enrolled participants will be randomized to receive the 10 week group-based intervention or 10 weeks of informational mailings; both groups will receive individual home-based sessions. Outcomes include maternal social support, psychopathology, sensitive parenting, child psychopathology, two-generational biobehavioral self-regulation targets (Respiratory Sinus Arrhythmia), parent and child emotion and behavior regulation, and dyadic behavioral and physiological synchrony. Assessments will occur at intake, post, and 6 months following the group.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment status in one of the following services: Supplemental Nutrition Assistance Program (SNAP), Family Independence Temporary Assistance Program (FITAP), Medicaid, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), or Head Start
* Maternal age of at least 18 years
* Mother is primary caregiver of child
* Mother speaks English
* Child age is between 3-5 years
* Family resides within 8 parish New Orleans metro area

Exclusion Criteria:

* Mother is not biological mother
* Diagnosis of a heart condition in the mother or the child
* Presence of a pacemaker in the mother or the child
* Child diagnosis of autism or global developmental delay
* Active maternal substance use
* Active maternal psychosis
Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Evaluation of Vaginal Microbiome As a Biomarker for the Improvement of Vaginal Health in Women with Breast Cancer, ARISE Study

This study evaluates vaginal microbiome as a biomarker to improve vaginal and sexual health in women with breast cancer receiving endocrine therapy. Breast cancer is the most common cancer in United States women, aside from skin cancers. Endocrine therapy is standard treatment for 70% of invasive breast cancers, significantly affecting sexual health and often causing women to change their course of treatment or cease sexual activity. Changes in the vaginal microbiome, which is the collection of all microorganisms, such as bacteria, fungi, and viruses, that naturally live on and inside the body, are implicated in menopausal-related sexual health symptoms, but the vaginal microbiome (and associated immune responses) has not been explored as a biomarker for sexual health changes in hormone-related sexual health symptoms in breast cancer. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. Ribonucleic acid (RNA)-sequencing is a cost-effective method to analyze both human and microbial transcripts. The RNA that is sequenced from a standard biological sample such as a swab is a snapshot of the expression of many different cells and can be used to simultaneously measure the quantities of microbes, the overall expression of the human host, and the quantities of immune cells. Information gathered from this study may help researchers establish the vaginal microbiome as a biomarker and therapeutic target to improve the vaginal and sexual health of women with breast cancer receiving endocrine therapy.

PRIMARY OBJECTIVE:

I. Determine whether individuals who experience vaginal dryness have a distinct microbiome prior to treatment from those who do not in a sample of breast cancer survivors initiating endocrine therapy.

EXPLORATORY OBJECTIVE:

I. Explore potential mechanisms of microbiome-associated vaginal toxicity through correlation with host gene expression and deconvolved immune cell abundances.

OUTLINE: This is an observational study.

Participants undergo vaginal specimen self-collection via vaginal swab collection kit, complete questionnaires, and have medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18 years and older
* Non-metastatic, estrogen and/or progesterone positive, human epidermal growth factor (HER) 2 negative breast cancer who will be receiving endocrine therapy, including tamoxifen, aromatase inhibitor, or ovarian suppression
* Endocrine positive women who have received chemotherapy (adriamycin and cytoxan + taxol; taxotere and cytoxan) will still be eligible but must have completed their treatment

Exclusion Criteria:

* Triple negative breast cancer patients
* Human epidermal growth factor (HER) 2 positive breast cancer patients
* Metastatic disease
Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery

The purpose of this study is to compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.

Patients scheduled to undergo phacoemulsification will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group) for three days preoperatively and four weeks postoperatively. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema.

Purpose:

To compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.

Methods:

This will be a masked single-center, randomized clinical study comprising 80 patients undergoing phacoemulsification cataract surgery. Patients scheduled to undergo phacoemulsification and with no recognized cystoid macular edema (CME) risks (diabetic retinopathy, retinal vascular disease or macular abnormality) will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group;n=40) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group;n=40) for three days preoperatively and four weeks postoperatively. In both groups topical gatifloxacin will be administered to the treated eye QID, starting three days before surgery and continuing for seven days. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema. Other included outcomes will be best corrected visual acuity (BCVA), intraocular pressure (IOP), CME incidence, retinal thickness as measured by spectral-domain optical coherence tomography (OCT).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with nuclear cataract, density 1 and 2 classified by LOCS II, scheduled to undergo phacoemulsification cataract surgery.

Exclusion Criteria:

* Patients with:

  * Diabetes,
  * Hypertension,
  * uveitis,
  * macular disease,
  * congenital ocular abnormalities,
  * cataract density 0 and 3 by LOCS II,
  * pseudoexfoliation syndrome.

Patients under treatment with nonsteroidal antinflammatory drugs or topical eye drops were excluded.
A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A

Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Ongoing participation in pathfinder™2
* Male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)

Exclusion Criteria:

* FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7
* Planned surgery during the trial
* Major surgery performed within 4 weeks prior to screening
* Previous participation in this trial. Participation is defined as signed informed consent
* Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol
Effect of Restriction of Foods Containing Phosphorus Additives

Hyperphosphatemia is related to the increase in morbidity and mortality. There is greater risk for cardiovascular disease, atherosclerotic disease, secondary hyperparathyroidism, and bone disease .

The serum phosphorus level can be controlled by a combination of factors, such as: reduction of ingestion, reduction of intestinal absorption with chelating agents and increase in elimination by dialysis.

The purpose of this study is to evaluate the effect of dietary intervention consisting of the restriction of industrialized foods with phosphorus additives in chronic kidney disease patients treated with hemodialysis.

The consumption of foods which contain phosphorus by patients on hemodialysis should be monitored in order to reflect the current reality, due to the increase in ingestion of industrialized foods rich in phosphorus additives. Data from studies performed in the USA shows a reduction in phosphatemia with nutritional orientation to reduce foods containing additives from restaurants in the region of the study . In another study, also conducted in the USA, the researchers evaluated the phosphorus content and presence of additives in appetizers and side orders served at fast food restaurants in Cleveland. The results showed that of the appetizers, 52% were accepted by the traditional criteria for the renal diet (low content of sodium, potassium and organic or natural phosphorus), but only 16% were also free of phosphorus additives; of the side orders, 23% were accepted by the traditional criteria and 17% were exempt of phosphorus additives. Thus, only a small proportion of appetizers and side orders served at fast food restaurants were compatible with the renal diet. Considering that alimentary phosphorus has an important role in the control of phosphatemia, there is a lack of studies which evaluates the effect of foods containing phosphorus additives on phosphatemia and which, at the same time, evaluated the alimentary ingestion and the nutritional state of the chronic kidney disease patients treated with hemodialysis.

Can the elimination of foods containing phosphorus additives and their substitution for foods without additives reduce phosphatemia without altering the nutritional state of hyperphosphatemic patients on hemodialysis?

Eligibility Criteria:
Inclusion Criteria:

* males or female ≥ 18 years of age
* Chronic kidney disease in stage 5, on hemodialysis for at least 6 months
* Serum phosphorus (P) greater than 5.5 mg/dL persistent in 3 previous months
* Preserved cognitive capacity and able to read and write
* Signed informed written consent

Exclusion Criteria:

* Use of enteral or parenteral therapy
* Presence of physical or cognitive limitation
* Malabsorption diseases.
A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients

48 PD patients (age 35-75y; H\&Y 1-3) testing positive in a stool PD-dysbiosis test will be randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal infusion. The main outcome measure will be the sum of MDS-UPDRS I-III at 6 months to cover motor and non-motor symptom changes. A wide array of secondary clinical outcome measures will be assessed longitudinally and a large array of measurements, biospecimens (stool, urine, blood, colonic biopsies), and imaging data will be collected for further analysis at baseline, 1, 6, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD (Clinically Probable PD)
* H\&Y OFF 1-3 at Baseline Visit

Exclusion Criteria:

1. Chronic gastrointestinal disease (IBS allowed, celiac disease allowed if on gluten free diet, gastritis allowed)
2. Any previous major gastrointestinal surgery that may alter gastrointestinal physiology
3. Any abdominal surgery in the last 3 months
4. Major genital and/or rectum prolapse
5. Active autoimmune disease
6. Active cancer within 5 years (allowed: basalioma and successfully removed carcinoma in situ)
7. Immune deficiency
8. HIV infection
9. Antibiotic use in last 3 months before baseline visit
10. Dementia as indicated by Moca \<21p
11. Psychosis
12. Active significant impulse control disorder (by interview and medical records)
13. Major depression as indicated by BDI-II \>28
14. Pregnancy
15. Alcohol or drug abuse
16. Negative dysbiosis test result
17. Iodine allergy
18. Deep brain stimulation or Duodopa/Lecigon treatment
19. Inability to interrupt regular use of NSAIDs for at least one month before permeability assessments
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.


Eligibility Criteria:
Inclusion Criteria:

* Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* LVEF ≥ 50% by either ECHO or MUGA
* Has adequate renal and hepatic function
* Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment

Exclusion Criteria:

* History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
* Known hereditary or acquired bleeding and thrombotic tendency