cyrilzakka/clinical-trials huggingface dataset:
Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation

The aim of our study is to prevent unnecessary intensive care unit hospitalizations by developing a scoring system to detect low-risk patients after elective intracranial neurosurgery operation.

In this study, the data of patients who are planned to undergo craniotomy by neurosurgery will be collected as a file scan (medical histories, drugs used, demographic features, additional diseases, ASA class, pre-operative routine parameters, operation history, GCS, tumor histology, location, dimensions and intracerebral radiological data, laboratory values). The pre-operative Quality of Recovery-15 (QoR-15) score will be recorded before the patient is taken into operation. Intraoperative; hemodynamic data of patients; highest and lowest values of heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products given, anesthetic and other drugs administered, duration of anesthesia, duration of surgery, surgical position, blood loss, urine output and blood gas samples will be written from the anesthesia document after the operation is over. For the study, the application of the anesthesiologist for the patient will not be interfered. After the operation; extubation time, MAS score, use of mechanical ventilation, post-operative complications (moderate to severe intracerebral hemorrhage on brain CT, intracranial hypertension requiring post op surgical drainage, development of status epilepticus or seizures, the need for tracheal intubation and mechanical ventilation after surgery, decrease in GKS, unmanageable agitation that requires restriction or sedation, need for respiratory failure and oxygen therapy, serious motor deficit and exitus) will be recorded in the service where the patient is sent. The post-operative QoR-15 score will be calculated 24 hours after the operation. Pre-operative and post-operative calculated scores of the patient will be evaluated and anesthesia recovery score will be created. With this recovery score, post-operative mortality and morbidity estimates will be made. The length of hospital stay of the patient will be recorded. Glasgow Result Scale (GOS) score will be determined 30 days after the patient operation. In this way, 1 month morbidity and mortality of the patient will be evaluated. The collected results will be statistically associated with anesthesia recovery and operation complications.

As a result, in our study; post-operative risk prediction score will be created in patients undergoing intracranial surgery with elective craniotomy.

Eligibility Criteria:
Inclusion Criteria:

1. To undergo intracranial operation with elective craniotomy
2. No history of congestive heart failure
3. No kidney and liver dysfunction
4. Not pregnant
5. To be over 18 years old

Exclusion Criteria:

1. To undergo an intracranial operation with emergency craniotomy
2. Patients with a history of congestive heart failure
3. Patients with kidney and liver dysfunction
4. Pregnant patients
5. Patients under 18 years old
Randomized Study of Photodynamic Therapy Using Dihematoporphyrin in Patients With Corneal Neovascularization

OBJECTIVES:

I. Demonstrate the safety and efficacy of dihematoporphyrin derivative (DHP) in laser photodynamic therapy (PDT) in patients with corneal neovascularization.

II. Document the histopathologic mechanism of action in selected patients undergoing penetrating keratoplasty following PDT therapy for corneal neovascularization.

III. Facilitate FDA product approval of DHP as a photosensitizing agent for laser treatment in these patients.

IV. Explore the use of this photosensitizer for ocular and cutaneous basal cell and squamous cell carcinoma.

PROTOCOL OUTLINE:

This is a randomized, placebo controlled study.

Patients are randomized to 1 of 3 treatment arms:

Arm I: Patients receive topical dihematoporphyrin derivative (DHP) every 3 hours on days -3 and -2. Patients undergo laser surgery on day 0. After photodynamic (PDT) therapy, patients receive topical prednisolone phosphate four times a day for 90 days. Ninety days following PDT, patients may undergo corneal transplantation.

Arm II: Patients receive placebo topical gel and undergo sham laser surgery following arm I schedule, then receive topical prednisolone phosphate four times a day for 90 days. Patients may be crossed over to arm I if disease progression is observed.

Arm III: Patients receive a compressed 1 day schedule of DHP with 5 doses in the morning and then undergo laser surgery in the evening.

Patients are assessed on days 1, 7, 30, and 90 after PDT therapy.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
* Histologically proven corneal neovascularization (CNV): Must have at least 1 quadrant of significant CNV, which is due to bacterial, viral, parasitic, or fungal keratitis; alkaline acid or hydrocarbon chemical burns; ocular trauma and injury; severe ocular surface disease; or previous surgery with complications such as corneal allograft rejection are eligible
* No concurrent systemic steroids
* No concurrent immunosuppressive therapy
* Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; HIV negative; No rheumatoid arthritis; No congenital corneal scars; No active ocular infection or inflammation; No other active systemic collagen vascular disease; No uncontrolled glaucoma; No history of porphyrin allergies; Visual acuity of 20/400 or better in contralateral eye
EPO906 in Carcinoid and Other Neuroendocrine Tumors

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause metastatic carcinoid and other neuroendocrine tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas) with at least one measurable lesion (other than bone) that has either not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy
* The patient has no major impairment of renal or hepatic function, as defined by the following laboratory parameters: total bilirubin \<1.5 X ULN; AST, ALT\<2.5X ULN (\<5 X ULN if liver metastases are present)
* Patients on Sandostatin Lar (long acting somatostatin analogue) must be on a stable dose for 30 days prior to study entry and short acting somatostatin analogues must be judged to be on a clinically stable dose by the investigator prior to study entry
* Must have a life expectancy of greater than three (3) months
* Karnofsky Performance Status \> 60
* Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.)

Exclusion Criteria:

* Patients with symptomatic CNS metastases or leptomeningeal involvement
* Patients with known brain metastases, unless these metastases have been treated and/or have been stable for at least six months prior to study start. Subjects with a history of brain metastases must have a head CT with contrast to document either response or progression.
* Patients with bone metastases as the only site(s) of measurable disease
* Patients with hepatic artery chemoembolization within the last 6 months (one month if there are other sites of measurable disease)
* Patients who have been previously treated with radioactive directed therapies
* Patients who have been previously treated with epothilone
* Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
* Patients with severe cardiac insufficiency patients taking Coumadin or other warfarin-containing agents with the exception of low dose warfarin (1 mg or less) for the maintenance of in-dwelling lines or ports
* Patients taking any experimental therapies history of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ
* Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
* Patients with a medical or psychiatric illness that would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
* HIV+ patients
* Pregnant or lactating females.
Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy

A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots
* Age \> 16 (if under 18, patients parents must sign consent).

Exclusion Criteria:

* Inability to lie supine for simulation \& treatment
* Inability to visualize the target nerve on either CT or MRI imaging
* Patients with confirmed pregnancy (all women of child-bearing age with intact uterus \& ovaries will be required to undergo a pregnancy test prior to simulation)
Single and Multiple Dose Safety, Tolerability, and Pharmacokinetics Study of PF-04805712 in Healthy Volunteers

To assess the safety and tolerability of escalating single and multiple doses of the compound in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females of non-childbearing potential.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer

This study aims to evaluate whether allowing unprotected vaginal intercourse 24 hours after frozen embryo transfer will result in higher ongoing clinical pregnancy rates in comparison to having participants abstain from unprotected vaginal intercourse until pregnancy test (10-14 days after frozen embryo transfer).

Given the overwhelming evidence suggesting beneficial effect of seminal plasma on embryo implantation, we sought to explore this benefits in in vitro fertilization treatments by limiting the study cohort to those having frozen embryo transfer with programmed hormone replacement for endometrial preparation and some form of parenteral progesterone supplementation. This design will enable us to overcome the concerns and limitations of all previous studies. In this study, patients will be randomized into two groups, group 1 will have their frozen embryo transfer followed by current standard of care (no unprotected vaginal intercourse until pregnancy test) and group 2 will have their frozen embryo transfer followed by unlimited unprotected vaginal intercourse starting 24 hours after transfer. The primary endpoint of the study will be ongoing clinical pregnancy

rates in the two groups while secondary endpoints will include implantation, positive pregnancy, miscarriage and live birth rates. Overall, this study aims to investigate whether the elimination of current universal pelvic rest protocol in patients undergoing frozen embryo transfer will help optimize pregnancy outcomes.

This study aims to evaluate whether allowing unprotected vaginal intercourse 24 hours after frozen embryo transfer will result in higher ongoing clinical pregnancy rates in comparison to having participants abstain from unprotected vaginal intercourse until pregnancy test (10-14 days after frozen embryo transfer).

Eligibility Criteria:
Inclusion Criteria:

* female fertility patients having frozen embryo transfer
* programmed hormone replacement (Oral Estrace, Vivelle dot (patch), intravenous Estradiol) with and without gonadotrophin releasing hormone analogue pretreatment and some form of parenteral progesterone supplementation (daily or every 3 days intramuscular Progesterone) for luteal support

Exclusion Criteria:

* unable to provide informed consent
* not undergoing programmed hormone replacement for frozen embryo transfer (natural cycle frozen embryo transfer)
* undergoing fresh embryo transfer
* not able to engage in heterosexual intercourse (same sex couple, partner with severe sexual dysfunction)
* cannot undergo unprotected vaginal intercourse (infected with hepatitis B, C, or human immunodeficiency virus).
Application of Digital Infrared Thermal Imaging (DITI) in Graves' Disease

Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy. Pathogenesis involves autoimmune process. The investigators think temperatures of the area involved in the inflammation may change. Thus the investigators plan to take temperature pictures of Graves' patients using digital infrared thermal imaging system and observe the change.

We will recruited patients of Graves' disease from out patient clinics. We will perform thyroid echo and soft tissue echo first. Then we let patients sit before the thermal camera and take thermal images of eyes necks and tibia. After data collection, we analyse the relation between temperature and laboratory data such as thyroid function and autoimmune profiles.

Eligibility Criteria:
Inclusion Criteria:

* Graves' disease patients. Healthy people

Exclusion Criteria:

* Pregnancy. \<16 years old or \> 60 years old
Diagnostic Importance of the C-reactive Protein From Blood and Saliva in Children With Acute Appendicitis

Diagnosing acute appendicitis in children is still a challenge even for experienced clinicians. Failure to recognize this acute condition can result in perforation, with consequent peritonitis, or misdiagnosis can result in negative appendectomies. C-reactive protein in blood can be elavated in children with acute appendicitis. The aim of this research is to compare the diagnostic value of C-reactive protein from the blood and saliva of children with acute appendicitis and to prove wheter the analysis of biomarker from saliva as a minimally invasive procedure can be sufficient for diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* children with age from 5 to 17 with acute abdominal pain
* children with clinical signs of appendicitis

Exclusion Criteria:

* previous diagnosis of chronic and/or malignant disease
* children wich had previous abdominal surgery
* pregnancy
Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System

This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central catheter (PICC) tip confirmation technology. The study was to promote the development of a software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform. All study participants received PICCs as their standard of care.

The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients.

In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. developed a software package, MODUS, which can accurately define the maximum p-wave on an ECG waveform. This software provides visual and/or audio queues to notify the PICC placer of the location of the tip of the PICC relative to the cavoatrial junction of the patient.

Subjects who required bedside PICC placement as standard of care and met eligibility criteria were enrolled. The software package was not used in the guidance or placement of the PICC tip. PICCs were placed per standard of care procedure using anthropometric measurements with the SHERLOCK 3CG™ TCS System. Data from the placements was sent back to Bard for analysis.

Eligibility Criteria:
Inclusion Criteria:

A subject must have met the following criteria to be enrolled in the study:

1. Male or female, age ≥ 21 years
2. Subject required PICC placement as part of standard of care
3. Subject had signed an Informed Consent Form (ICF) or had an ICF signed by the subject's legally authorized representative

Exclusion Criteria:

* A subject was excluded if any of the following criteria were met:

  1. Subject had a contraindication to PICC placement as listed in the Instructions for Use (IFU)
fMRI Study to Investigate Hemodynamic Changes in Brain Resulting From Supplementation of Bacopa Monnieri Extract and Multiple Micronutrient Supplementation.

The study will aim to compare the effects of a beverage powder fortified with multiple micronutrients and Bacopa monnieri extract (test product) to a non-fortified isocaloric beverage powder (control product) on cognitive outcomes of attention and working memory.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent from participant's parents/ legally acceptable representative (LAR) and voluntary written assent from the subject and a signed, dated copy of the informed consent and assent forms.
* Right handed, School going children (participants) aged 11-12 years, inclusive
* Satisfactory completion of baseline imaging scan basis participant's ability to stay still, with acceptable MRI/fMRI image quality as determined by technical expert at the imaging centre
* Compliance of participant and participant's parents/LAR with all study procedures and restrictions.
* Participant is able to read and comprehend one of the languages used for cognitive assessment (English or Hindi)
* Participant with Z-scores of Body Mass Index (BMI) for age of \>-2 to \<+1

Exclusion Criteria:

* Child in Care (CiC); A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. A CiC does not include a child who is adopted or has an appointed legal guardian.
* Known or suspected intolerance or hypersensitivity to the study materials, any of their stated ingredients or any known food allergies like nut allergy, gluten allergy or lactose intolerance.
* Severe anemia with hemoglobin\<8g/Dl, Attention Deficit Hyperactivity Disorder (ADHD), reading dyslexia or any other behavioral disorder.
* Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit or previous participation in this study.
* Participation in any nutritional study within 6 months prior to the screening visit.
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder
* Health conditions affecting food metabolism including food allergies, kidney disease, liver disease and/or gastrointestinal diseases.
* Use of concomitant medication that might interfere with the outcome of the study or increases the risk to the participant.
* Currently taking any other health food drinks/beverages or supplements (including nutritional supplements) or has been on supplements within a month prior to study start.
* Participant whose sibling is already a participant of this study.
Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)

This study will evaluate the efficacy, immunogenicity, and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese men 20 to 45 years of age. It will enroll heterosexual men (HM) and men who have sex with men (MSM), will be stratified by age and sexual orientation, and will have two stages. The primary hypothesis of Stage I is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related external genital and intra-anal 12-month persistent infection (PI) compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative from Day 1 through one month post-Dose 3 to the relevant HPV type. The primary hypothesis of Stages I and II combined is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), or penile/perianal/perineal cancer compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and PCR negative from Day 1 through one month post-Dose 3 to the relevant HPV type.


Eligibility Criteria:
Inclusion Criteria:

* Is a Chinese male.
* Has no more than 5 lifetime sexual partners.

Exclusion Criteria:

* Has a history of known prior vaccination with an HPV vaccine.
* Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.
* Has a history of severe allergic reaction that required medical intervention.
* Has received immune globulin or blood-derived products in the past 3 months or plans to receive any before Month 7 of the study.
* Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
* Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.