cyrilzakka/clinical-trials huggingface dataset:
Effect of Propofol Midazolam on Cerebral Oxygenation and Metabolism During Clipping of Ruptured Cerebral Aneurysm

Despite the theoretical benefits of i.v. agents, volatile agents remain popular. In a study comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and ICP were least with sevoflurane.

Propofol is the most commonly used intravenous anesthetic. It has many theoretical advantages by reducing cerebral blood volume (CBV) and ICP and preserving both autoregulation and vascular reactivity. Neurosurgical patients anaesthetized with propofol were found to have lower ICP and higher CPP than those anaesthetized with isoflurane or sevoflurane.

The well known pharmacodynamic advantages of intravenous anesthetics may give this group of drugs superior cerebral effects when compared with inhalation anesthetics.

The aim of this study is to evaluate the cerebral hemodynamics and global cerebral oxygenation as well as the systemic hemodynamic changes using midazolam and propofol as total intravenous anesthetics (TIVA) in comparison with sevoflurane anesthesia in clipping of ruptured cerebral aneurysm.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status III or IV.

Exclusion Criteria:

* Morbid obese patients.
* Severe or uncompensated cardiovascular diseases
* Severe or decompensated renal diseases
* Severe or decompensated hepatic diseases
* Severe or decompensated endocrinal diseases.
* Pregnancy
* Postpartum
* Lactating females
* Allergy to one of the agents used.
* Severely altered consciousness level.
* Sitting or prone position during surgery.
FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD)

Hypothesis:

Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to colonoscopy in the management of patients with Inflammatory Bowel Disease.

Objectives:

By means of a survey from the ordering physician we would assess:

Primary Endpoint

1. The Percentage of time that the Fecal Calprotectin result caused the physician to change the management of a patient.

Secondary Endpoints

1. To determine if the Fecal Calprotectin result influenced the number of endoscopies performed
2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when endoscopy was performed.
3. To assess the correlation between the Fecal Calprotectin level and symptoms as measured by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if endoscopy was performed).

Patients will be identified as eligible by the attending Gastroenterologist during the course of a usual consultation. Patients will be referred to the research nurse in the doctor's office for further information regarding the study and informed consent will be obtained by the research nurse.

Upon enrollment, the physician or the research nurse will complete an online requisition form with a unique code which will provide the baseline data. The patient will be provided with the Easy Sampler™ collection kit and instructions on the use of this kit and location on where to send the specimen.

The nurse will then send an email to the research nurse in the originating physician's office with the result of the calprotectin assay. The research nurse will review the result with the physician. After physician review, either the physician or the research nurse will then complete a follow up survey online.

After completion of the assays and surveys, the data will be tabulated electronically from the online website and analyzed by the PI and/or co-investigators.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 19 years of age or older, they must be able to read and provide written consent in English.

Subjects will have gastrointestinal symptoms or be known to have Inflammatory Bowel Disease whereby the clinician feels that obtaining Fecal Calprotectin may be useful in the care of the patient. Patients must be able to collect a feces sample and return it for analysis within 3 days

Exclusion Criteria:

* Known Ischemic colitis, infectious enteritis or colitis, known colorectal cancer, history of extensive bowel resection, ostomy, current daily use of NSAIDs (aspirin, ibuprofen, naproxen, etc) or the inability to collect sample and return it within 3 days
Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic injections of 2 different dose levels of the investigational short and tall ragweed product. Biomarkers will be assessed at baseline and at multiple time points post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 16 and 65 years old
* Seasonal Allergic Conjunctivitis (with or without Allergic Rhinitis) to ragweed pollen
* Positive skin test reaction at screening visit to short ragweed extract
* Avoid disallowed medications
* Females of childbearing potential must have pregnancy test and must agree to use an acceptable method of birth control
* Have blood and urine analysis within normal limits
* Manifest a positive reaction to a conjunctival allergen challenge with ragweed pollen
* Have a specific IgE ≥ 0.70 kU/L to short ragweed

Exclusion Criteria:

* Have ocular or nasal conditions that could affect subject safety or trial parameters
* Have a presence of an active sinus, nasal, or ocular infections
* Have had allergy immunotherapy to ragweed pollen
* Have a compromised lung function ≤80% of predicted
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
* Tumor Specimen availability

Exclusion Criteria:

* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab
* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
* Active hepatitis B or C or tuberculosis
* Positive test for human immunodeficiency virus (HIV) infection
* Acute or chronic active Epstein-Barr virus (EBV) infection at screening
* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Active or history of autoimmune disease
* Prior allogeneic stem cell or organ transplantation
Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes

Premacular Subhyaloid hemorrhage is a sudden profound loss of vision in eyes with proliferative diabetic retinopathy (PDR). Pars plana vitrectomy is the treatment of choice for premacular hemorrhage in eyes with proliferative changes. Nd:YAG laser hyaloidotomy has been used to evacuate the premacular hemorrhage


Eligibility Criteria:
Inclusion Criteria:

* Eyes with premacular subhyaloid hemorrhage of more than 3 disc diameters, involving the fovea.
* Eyes with proliferative diabetic retinopathy

Exclusion Criteria:

* Dense media opacity (corneal/cataract)
* Patients with bleeding tendency or on anti-coagulant drugs
The Effects of Sex Hormones on Cognition and Mood in Older Adults

This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.

Double-blind, placebo-controlled, crossover study investigating the effects of estrogen replacement and testosterone replacement on cognition and mood in older adults. Women who have not had a hysterectomy will be given Prempro (estrogen with progesterone to protect the uterine lining), and hysterectomized women will be given Premarin (estrogen only).

Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 65-90 who have not received hormone replacement for the last three months.

Exclusion Criteria:

* Previous head injury with loss of consciousness for more than one hour.
* Men with a history of prostate cancer.
* Men on testosterone replacement within the past three months.
* Women with a history of breast or uterine cancer.
* Women on estrogen replacement within the past three months.
Optimization of the Acquisition Sequence to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam

The purpose of this study is to evaluate the optimization of MRI acquisition sequences.


Eligibility Criteria:
Inclusion Criteria for all subjects :

* to be over 18 year-old,
* to be able to understand the instructions given,
* to be enrolled in a social security plan,
* to have underwent a pre-inclusion medical examination,
* to give a written consent.

Inclusion Criteria especially for Patients :

* to perform a MRI examination of the head, neck, spine, thorax, abdomen, pelvis, retroperitoneum, lower limbs, upper limbs or whole body during clinical follow-up care.

Exclusion Criteria for all subjects :

* any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, ... ),
* subject under a measure of legal protection.

Exclusion Criteria especially for Healthy Subjects :

* to have a pathology in the anatomical area to be imaged
* to be employed by the CHRU of Nancy or having the slightest link of subordination with the CHRU of Nancy.

Exclusion Criteria especially for Patients :

* to have a limited MRI examination time due to a sensitive clinical situation (sedation, unstable hemodynamic state, postoperative).
The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities

pelvic congestion is the most recognized consequence of pelvi-perineal venous insufficiency .

chronic pelvic pain prevalence is about 26.6 %in egypt. this research is going to evaluate the effectiveness of foam sclerotherapy and to conclude diagnostic and therapeutic algorithm for this problem.

this study includes clinical and imaging and interventional aspects. detailed history and comprehensive examination of the patient. duplex ultrasonography to detect pelvic varices and presence of reflux. renal and left iliac venogram is usually the first step in the evaluation of compressive syndrome. then cannulate the gonadal and internal iliac veins selectively. contrast medium injected , the incompetent gonadal veins are generally dilated and the contrast pools in the pelvis after injection. embolization by injecting afoam sclerosant as distally as possible to occlude the pelvic venous plexus using occlusion balloon proximal.

follow up assessment by VAS score and duplex imaging.

Eligibility Criteria:
Inclusion Criteria:

* premenopausal women ovarian point tenderness post coital pain atypical lower limb varices

Exclusion Criteria:

* endometriosis diverticulitis fasciitis psychosexual dysfunction
Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin

This study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary grafting. This grafting is done from the patient's chin using a computer-guided stent that is customized for each patient, and the cleft volume is analysed at first to estimate the needed amount of bone to be harvested.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.
2. Patients seeking treatment and accepting to be enrolled in the study, so as their guardians.
3. Patients who will age 9-14 years old by the surgery day.
4. Patients with adequate chin bone volume that could be harvested without marked donor site morbidity, as pre-determined by cone beam computed tomography.

Exclusion Criteria:

1. Patients with systemic illness, i.e. ASA(22) classes II, III, IV, and V.
2. Patients with previously operated alveolar clefts and seeking revision for the same cleft.
3. Patients that wouldn't be able to attend the recalls.
4. Patients with other craniofacial anomalies and associated syndrome conditions.
5. Edentulous maxilla, atypical or non-described cleft diagnosis.
6. Patients with history of chemotherapy or radiotherapy.
Efficacy of an Intranasal Stent on Nasal Obstruction at Night

This study aims to demonstrate a decrease with normalization of nasal resistance in the forward decubital position and with an intra-nasal stent in patients with nasal obstruction.

All patients consulting for nasal obstruction at night and who have functional nasal test with pathological resistance in decubitus position are included.

Functional nasal test (non invasive tests) will be performed before and after intranasal introduction of a stent: anterior rhinomanometry to measure nasal function by the measure of resistance and acoustic rhinometry to measure the geometry of nasal fossa by the measure of minimal sectional cross area sitting, after 30 minutes of decubitus then new measurements with a stent in decubitus position in each nostril .

Eligibility Criteria:
Inclusion Criteria:

1. Volontary patient
2. Over 18 years old or more.
3. Complain of a nasal obstruction more important (or only) at night (in decubitus position)

Exclusion Criteria:

1. Unability to sign the consent form
2. Allergy of stent component
3. Perforation of nasal septum
4. Haemostasis disorder or anticoagulant therapy
5. Bilateral obstructive septal deviation ou polyposis induce inability to introduce the stent in the nasal cavities
Efficacy of Extract of Trigonella Foenum-graceum as Topical Phytoestrogen in Skin Aging Treatment of Post Menopausal Women

Skin is subjected to intrinsic aging and extrinsic aging. Intrinsic aging is influenced by genetic and hormonal factors. Estrogen has significant role in modulating skin physiology. In post menopausal women, skin aging is accelerated because of hypoestrogenism. Administration of estrogen can delay the process of skin aging. Phytoestrogens are estrogen-like compounds which can be found naturally in plants. The investigators intend to study the efficacy of Trigonella foenum-graceum extract as topical phytoestrogen in skin aging treatment of post menopausal women.

In this double-blinded unmatched randomized controlled trial, the investigators intend to study the efficacy of Trigonella foenum-graceum extract as topical phytoestrogen in skin aging treatment of post menopausal women. The investigators have gathered 21 participants that will be divided into 2 groups, experimental group and control group. Experimental group will get treatment with topical cream containing Trigonella foenum-graceum extract, while control group will get treatment with placebo cream.

The study will be held in esthetic cluster, Kencana Cipto Mangunkusumo Hospital, and radiology cluster, Kencana Cipto Mangunkusumo Hospital from August 2019 until November 2019.

Eligibility Criteria:
Inclusion Criteria:

* Women with minimum 2 years post menopausal and maximum 8 years post menopausal
* Have skin aging problems that manifested as wrinkles on forehead, crow's feet, and nasolabial fold region
* Estradiol level \< 30 pg/mL
* Willing to terminate the routine use of facial cream or treatment during the study duration and at least for 30 days before the study commence
* Willing to follow the study protocol and sign the informed consent

Exclusion Criteria:

* Dermatitis in the region of face
* Using oral/topical hormonal supplement in the last 12 months
* Using products containing retinoic acid or it's derivatives in the last 30 days
* Underwent radiotherapy, facelift, dermabrasion, botox, or facial filler procedures in the last 5 years
* Breast lump or other breast abnormality
* History of cancer or malignancy
* Vein thrombosis
* History of hormonal contraception allergy
* History of ovariectomy
Effect of Antireflux Therapy on the Expression of Genes in Patients With GERD

Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux therapy are well known and extensively studied, little is known of the genetic events occurring in response to proton pump inhibitor therapy. Preliminary data from our laboratory has shown, for example, that COX-2 expression is not only elevated in patients with gastroesophageal reflux disease but also can be correlated with pathologic esophageal acid exposure on 24 hour pH monitoring. Similar studies have suggested that antireflux surgery may normalize COX-2 gene expression. In contrast studies following ablation of dysplastic Barrett's epithelium have shown persistence of genetic changes associated with altered cellular function, despite the return of the histologic appearance to normal. Several key mediators of inflammation, metaplasia (Barrett's) and neoplasia have now been well characterized and shown to be important factors in the pathogenesis of esophageal injury. It is likely that successful antireflux therapy returns altered expression of these mediators toward normal although this hypothesis remains largely unexplored. The aim of this study is to investigate gene expression of key mediators of the spectrum of esophageal mucosal injury and the response to antireflux therapy.

Hypothesis: Antireflux therapy (proton pump inhibitor and surgical fundoplication) normalizes the expression of genes known to be involved in the pathogenesis of inflammation (esophagitis), metaplasia (Barrett esophagus) and neoplasia (adenocarcinoma).

Aims: To determine the effects of antireflux therapy (pump inhibitor and surgical fundoplication) on gene expression of:

1. inflammation: IL-8, IFN-g, TNF-a.
2. intestinal metaplasia: CDX-1/2, MUC2 and Sonic hedgehog.
3. Neoplasia: Cox-2, VEGF, and EGFR.

Eligibility Criteria:
Inclusion Criteria:

For patients with GERD

* Patients referred for anti-reflux surgery
* On PPI therapy for at least 6 months
* Positive ambulatory pH monitoring (%time pH\<4 \> 4.7)
* Age greater than 18 years old.
* Both genders

For non-GERD controls

* Negative ambulatory pH monitoring OR
* Upper endoscopy performed for non-GERD symptoms.
* Age greater than 18 years old.
* Both genders

Exclusion Criteria:

* Prior foregut surgery
* Contra-indications for operation (poor clinical status, etc.)
* Contra-indications for endoscopy and biopsy (esophageal or gastric varices, therapeutic anticoagulation with Coumadin or Heparin, etc.)
* Unwillingness to participate in all of the follow-up studies
* Pregnancy
* Patients using medications that may interfere with PPIs pharmacokinetics (sucralfate, ketoconazole (Nizoral), ampicillin (Omnipen, Principen), digoxin (Lanoxin, Lanoxicaps), and iron (Feosol, Mol-Iron, Fergon, Femiron).
* Patients using medications that may interfere with gene expression (Immunosuppressants, Aspirin, NSAIDs, Corticosteroids).
* Patients with diseases that may interfere with gene expression (autoimmune diseases, diseases that course with immunosuppression).
Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock

There is a knowledge gap regarding the optimal initial fluid to achieve effective resuscitation and improved outcomes in septic shock. The purpose of this study is to compare initial resuscitation with plasma to initial resuscitation with balanced crystalloids.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the following criteria will be enrolled: Have a Sepsis Screening Score (SSS) ≥ 4 with a suspected source of infection (Table 1); and Written informed consent obtained
* Patients meeting any of the following criteria will be randomized: Hypotension with MAP \< 65 mmHg; Lactic acid \> 4 mmol/L; Altered mental status; and Decreased urine output of \< 0.5 mL/kg in the past hour.

Exclusion Criteria:

* Pregnancy
* Prisoners
* Traumatic brain injury
* Evidence of ongoing hemorrhage, history of congenital bleeding disorders, therapeutic anticoagulation
* History of myocardial infarction or congestive heart failure
* History of acute cerebral vascular event
* Major burns (\>20% total body surface area)
* History of adverse reactions to blood product transfusion
* Contraindications to blood transfusions (eg. Jehovah's Witness)
* Contraindications to central venous line and arterial line placement
* On intermittent hemodialysis
* Do-Not-Resuscitate or Comfort Care status
* Participation in another interventional study
* Pending transfer to another unit within the hospital that is not STICU or SIMU
Endoscopic Band Ligation Versus Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial

The investigators goal is to compare the standard argon plasma coagulation (APC) treatment with endoscopic band ligation (EBL) in patients with Gastric Antral Vascular Ectasia.

Gastric antral vascular ectasia (GAVE) is a vascular structural malformation in the stomach that can lead to active or chronic intermittent gastrointestinal bleeding or chronic iron-deficiency anemia.

The current standard endoscopic treatment is with APC. There have been multiple reports and case series in the literature about successful treatment with EBL for GAVE, even in cases where APC was unsuccessful for treatment of GAVE. Our goal is to compare the standard APC treatment with EBL in patients with Gastric Antral Vascular Ectasia.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with GAVE identified at endoscopic examination, patients may have active GI bleeding, chronic anemia or drop in hemoglobin levels.

Exclusion Criteria:

* Patients with previous endoscopic treatment for GAVE within the last 3 months, patients with GAVE without chronic anemia or active bleeding, patients in whom another possible source of GI bleeding is found