cyrilzakka/clinical-trials huggingface dataset:
Doxycycline in Acute Traumatic Brain Injury

evaluate the impact of Doxycycline on both clinical outcome and blood levels of NSE in patients with TBI.

1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damnhour University.
2. All Participants agreed to take part in this clinical research and provide informed consent. for unconscious participants, the informed consent was obtained from their legally authorized representative.
3. Patients with moderate to severe TBI will be enrolled from Tanta university hospitals.
4. Serum samples will be collected for measuring the biomarkers.
5. Our design is randomized, controlled study.
6. All enrolled patients will be divided into 2 groups, Group (1) 25 patients that receive doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 days, and group (2) will be 25 patients will receive placebo in addition to the standard treatment.
7. All patients will be followed up during ICU period.
8. Statsicial tests appropriate to the study design will be conducted to evaluate the significance of the results.
9. Measuring outcome: the primary outcome is the change in the serum level of acute brain injury biomarkers.
10. Results, conclusions, discussion and recommendations will be given.

Eligibility Criteria:
Inclusion Criteria:

1. Hospital admission in the first 24 h of injury,
2. 18 to 90 years of age and
3. Both sexes with moderate to severe traumatic brain injury (GCS score ≤ 12).
4. Able to tolerate enteral feeding and drug administration within the first 24 hours of TBI

Exclusion Criteria:

1. Hypersensitivity to tetracyclines
2. Pregnant and breast feeding women,
3. History of autoimmune disease.
4. History of receiving chronic steroid treatment and isotretinoin,
5. Pre-existing hepatic (AST, ALT greater than 3 times the upper limit of normal) or renal failure (BUN/ Creatinine 20:1; creatinine \> 2 mg/dL),
6. Known malignancies
Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause

Genitourinary syndrome of menopause (GSM) is a collection of symptoms and signs caused by hypoestrogenic changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder that occur in menopausal patients.

Platelet-rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patient's arm. The blood is spun using a centrifuge that separates the plasma and red blood cells.

The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet-rich plasma, etc. The observational cohort study will be used for the study design. Questionnaires, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used to evaluate the effectiveness and side effects.

PRIMARY OBJECTIVE:

To determine the safety and feasibility of using platelet-rich plasma (PRP) treatment in menopausal patients with genitourinary syndrome

SECONDARY OBJECTIVE:

To determine the preliminary efficacy in the treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms

VSQ, Vaginal health index, Vaginal maturation index, and Day-to-Day Impact of Vaginal Aging score will be used for assessments.

OUTLINE:

Patients receive platelet-rich plasma via injection into the vaginal area after obtaining plasma into PRP tubes

After 3 sessions of PRP treatment, patients are followed up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Women with menopause
* Patients with symptoms of genitourinary syndrome of menopause

Exclusion Criteria:

* Genitourinary bleeding or infection without a definitive diagnosis
* Coagulopathy
* Allergy to medication or therapy related to the treatment
* Chronic disease that might influence the outcome
* Using medication that might influence the outcome in 30 days
* Using hormone or steroid within 8 weeks
* Personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus, vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent urinary tract infection, genital infection, history of vaginal or pelvic radiation
* Chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity
* Pelvic organ prolapse greater than stage II
* Pelvic surgery within 6 months
* Known allergy to lidocaine or prilocaine
* Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of therapy
* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients

The aim of this study is to examine the impact of implementing a standardized pain therapy protocol and their components on postoperative pain trajectories and postoperative outcomes such as increased opioid consumption and to compare it for different orthopaedic operations, i.e. major shoulder, hip, knee und spine surgery.

A multimodal standardized pain management was implemented at the Schulthess Clinic in 2002, followed by the gradual introduction of a standardized ultrasound-guided perioperative regional anaesthesia program. Along with these measures, an improved preoperative screening process for patients at risk of increased post-operative pain has been installed and an improved individual pain assessment in the perioperative period has been introduced. This allowed for the creation of pain trajectories, which the pain team started to use to identify gaps in the management of different patient groups. An example of a trajectory group is shown in Figure 1. These pain trajectories have not yet been evaluated for the overall implementation cycle of the multimodal standardized pain management in order to further improve postoperative care especially for patients with a history of chronic pain and those prone to opioid overconsumption.We hypothesise that pain trajectories have changed significantly over the study period as standardised pain management has been implemented. We also hypothesise that patients with chronic pain and increased opioid consumption will have different pain trajectories compared to all other patients. However, we believe that the pain trajectories for different orthopaedic surgeries do not show much variation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary hip and knee arthroplasties or revision surgery:CHOP Code: 81.51, 81.52, 81.52, 81.54
* Patients undergoing primary shoulder or revision surgery: CHOP codes: 81.80.11, 81.80.12, 83.64.11, 81.82.35, 81.82.45, 81.82.46, 81.82.47
* Patients undergoing major spine surgery: CHOP Code: 7A.6, 7A.7

Exclusion Criteria:

- Patients who did not sign general informed consent (for the Schulthess Clinic).
Controlled Education Of Patients After Stroke

The main objective of the study is to compare the benefit of optimised follow-up by nursing personnel from the vascular neurology department, including therapeutic follow-up and an educational program directed to the patient and a caregiving member of his social circle, with that of a typical follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 60 years of age
* Patients who have had a first stroke, transient or permanent, ischaemic or haemorrhagic, justifying hospitalisation
* Patients with high blood pressure already treated or discovered at the time of the stroke and justifying the start of a treatment
* Patients who have had a stroke with sequelae allowing immediate return home or justifying a stay of less than one month in rehabilitation
* Patient having a member of his social circle who has agreed to provide follow-up for two years in association with the assigned nursing personnel in case of randomisation into the "optimised follow-up" group.

Exclusion criteria

* Patients less than 60 years of age
* Patients with a history of stroke
* Patients who do not have high blood pressure discovered by a treatment prior to the stroke or by abnormal blood pressure figures during hospitalisation
* Patients who have had a stroke causing serious sequelae, justifying an extended stay in a rehabilitation department
* Patient who has no one in his social circle capable of working with the assigned nursing personnel, or patient living in an institution
Inherited CAncer REgistry

The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals interested in participating in studies focused on inherited cancer predisposition the opportunity to enroll in a research registry. Efforts through the registry include, but are not limited to, contribution of data to observational studies, targeted gene-specific studies, and education and outreach efforts for both participants and recruiting healthcare providers. Participants are given the opportunity to learn about and participate in other efforts for which they may be eligible.

All participants and recruiting healthcare providers receive educational newsletters twice per year which contain research and clinical updates in the field of cancer genetics. Providers who recruit patients can also access monthly web-based genetics case conferences which focus on different topics each month and are generally attended by a guest expert who provides background information on the topic as well as comments on the case presentations.

Participation in ICARE involves completion of an informed consent form, baseline questionnaire, follow-up questionnaires every two years, and medical record/tumor releases, as applicable. There is no cost to participate and all correspondence can be facilitated through phone, email, or mail.

Enrollment can be completed either through a traditional paper-based consenting method (i.e. postal mail) or through the online enrollment option available on the ICARE website (InheritedCancer.net). If you are a patient interested in learning more or a provider interested in recruiting to ICARE, please visit our website where you may complete an online contact form requesting a study team member contact you.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Able and willing to provide informed consent
Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product

An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis

* Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis.
* Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating females 12-17 years of age.

Exclusion Criteria:

* Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
Evaluation of Endoscopic Thyroidectomy Via Axillo-breast Approach in Thyroid Nodules

Evaluation of Endoscopic Thyroidectomy via Axillo-breast Approach in Thyroid Nodules regarding safety and cosmetic outcomes


Eligibility Criteria:
Inclusion Criteria:

* benign thyroid nodules unilateral or bilateral Normal thyroid function

Exclusion Criteria:

* malignant Thyroid Nodules Recurrent goitre Toxic goitre
Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer

This is a two-part study. Part I is an observational study. Part II is a randomized clinical trial to see how well medical nutrition therapy works compared with standard care in treating patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer.

In Part II of the study, patients are stratified according to tumor type (pancreatic vs lung vs prostate). Patients are then randomized to 1 of 2 arms.

* Arm I (Medical nutrition therapy): intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule.
* Arm II (standard care): Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during \& after treatment".

In both arms, patients' weight, fat free mass, and Patient Generated Subjective Global Assessment Score (PG-SGA) score will be assessed before, during, and after the intervention. The PG-SGA includes a patient report of symptoms and a healthcare professional assessment of medical, metabolic, and physical parameters.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with one of the following:

  * Pancreatic cancer
  * Lung cancer
  * Stage III or IV prostate cancer
* Undergoing treatment at The Cancer Institute of New Jersey

  * Are undergoing chemotherapy (part 2 only)
* Has lost ≥ 5% of their usual body weight in the previous 6 months (part 2 only)

PATIENT CHARACTERISTICS:

* Life expectancy \> 60 days
* Must speak and read English
* Accessible in person or by phone for completing questionnaires
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring

The Psychiatric Emergency Services (PES) is an under researched area of clinical practice, largely in the management of acutely agitated and violent patients. The goal of this pilot randomized clinical trial (RCT) is to assess the benefit of medically monitoring patients that present with extreme agitation and/or violent behaviour to PES. Placing them in physical restraints and immediately administering chemical restraint, will enable medical monitoring of these potentially medically unstable patients. Investigators believe that this practice will provide safer management of patients, reduce risk to staff and other patients, reduce risk of undiagnosed medical conditions that underly the agitation, and increase clinical management and quality of care. Patients that come into the Emergency Department that are agitated and violent, where verbal-deescalation will not suffice, will be randomly treated with either immediate placement in seclusion (current practice) or be placed in physical restraints and given chemical restraint (as outlined in the BETA project guidelines). The same time interval assessments will be performed on both groups of patients including; medical monitoring and agitation scale assessment. Data will also be collected on number of violent episodes, code whites, required increase in the use of physical restraints, length of intervention, and more. This assessment will enable a comparison between the current practice and the proposed practice to establish evidence based clinical guidelines for the management of acute agitation in PES, where de-escalation techniques are ineffective and the lack of medical monitoring is harmful to the patient and can negatively effect their outcome. In order to best assess the importance of medical monitoring for such patients, a pilot study must be performed to assess the feasibility of such a phase III RCT study.


Eligibility Criteria:
Inclusion Criteria:

* Was agitated or violent upon entry into PES.
* Is 18+ years of age.
* Verbal de-escalation techniques are not useful for management of this patient.
* BETA Project techniques alone are not useful for management of this patient.
* The patient is assigned a CTAS1 or CTAS2 score.

Exclusion Criteria:

* The patient scores a "Low" or "Moderate" level of risk on the Violence/Aggression Screening Tool (VAST) that is used at ER triage.
* The point of agitation or violence began after the patient was already admitted to PES.
A New Syndesmotomy Technique for Tooth Extractions to Preserve the Alveolar Bone

In both surgical and nor surgical tooth extractions, the first phase is done by syndesmotomy. This procedure allows to interrupt the fibers of the periodontal ligament. Traditionally, syndesmotomy is done by manual instruments. Usually, the manual approach leads to the loss of the vestibular cortical plate due to the size of those instruments.

The piezoelectric surgery device provides an alternative to manual instruments. Its advantages are: selectivity for hard tissues; better cut control; protection of soft tissue, vessels and nerves; post-op pain and discomfort reduction.

The aim of this study is to evaluate a piezosurgery driven syndesmotomy technique during tooth extraction.

Piezoelectric bone surgery is a recent and innovative technology, permitting a selective cut of mineralized tissue while sparing soft tissue. Similar to a dental scaler, a high frequency vibration, in the range of 25-35 kHz, is transmitted to a metallic tip. The handpiece of the instrument is equipped with a sterile irrigation system and light-emitting diode (LED) light, which improves visibility and overall safety. Piezoelectric surgery is particularly useful when performing delicate bone procedures such as periodontal or endodontic surgery. It is also indicated when performing more invasive bone surgery such as maxillectomy, mandibulectomy, and condylectomy, where preservation of neurovascular structures is important. Piezoelectric surgery is still employed in tooth extraction of third lower molars. In literature, there are low evidence of the use of piezoelectric surgery for single-rooted tooth extraction.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Single-rooted tooth to extract that:
* has mobility grade 0 or 1
* is considered hopeless or needs to be extracted due to orthodontic indication
* Sign of informed consent

Exclusion Criteria:

* Age lower than 18 years old
* Pregnancy
* Heavy smokers (more than 10 cigarettes a day)
* Uncompensated systemic diseases
* Drugs that influence wound healing (radiotherapy in the last year, bisphosphonates)
* Low compliance due to psychiatric diseases
* Mobility grade 2 or 3
* Refusal of informed consent
The Leaflex™ Early Feasibility Study

A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.

Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patient with symptomatic, severe aortic stenosis who are operable, but not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement.
* Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent.

Exclusion Criteria:

* Inoperable for emergency surgery.
* Moderate or greater aortic regurgitation.
* Anatomic contraindications.
* Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure.
* Aortic balloon valvuloplasty ≤ 3 months prior to index procedure.
* Stroke ≤ 12 months prior to index procedure.
* History of a myocardial infarction ≤ 6 weeks prior to index procedure.
* Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy.
* Hemodynamic instability.
* Hypertrophic cardiomyopathy with obstruction.
* Left ventricle ejection fraction \<30%.
* Ongoing severe infection, including endocarditis, or sepsis.
* Life expectancy ≤ 12 months.
Effect of Gynostemma Pentaphyllum Tea in Insulin Sensitivity in Type 2 Diabetic Patients

The aim of the present study was to investigate the effects of Gynostemma Pentaphyllum tea on insulin sensitivity in drug-naïve type 2 diabetic patients.

In Vietnam, traditional herbal medicines have played a major role in the management of diabetes for centuries. Gynostemma Pentaphyllum (GP) Makino (Family Cucurbitaceae) is a perennial creeping herb growing wild in the mountainous regions of Vietnam, China and some other Asian countries and was widely used in Southeast Asian countries as an herbal medicine and being beneficial for the prevention and treatment of diabetes. We have previously published the evidences that GP tea possessed anti-diabetic effect with good safety data in newly diagnosed T2D patients, and had effect on insulin sensitivity. In addition extract of GP had been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker Fatty rats. So the present study was to investigate the effects of Gynostemma Pentaphyllum tea in insulin sensitivity in type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, drug-naive patients with type 2 diabetes
* Fasting plasma glucose: 7-11 mmol/l
* HbA1C: 7-9%.

Exclusion Criteria:

* Type 1 diabetes
* Liver and kidney failure
Cerebral Oxygenation Values in Healthy Adults Volunteers Measured With RheoPatch and NIRO-200NX

Noninvasive measurement of cerebral tissue oxygen saturation levels by near infrared spectroscopy (NIRS) is clinical routine in perioperative medicine. One of the main technical challenges of NIRS measurements is to eliminate the influence of signals of the skin and skull. A new device (RheoPatch, Luciole Medical AG, Zurich) has been developed by a company that also developed an intracranial NIRS probe, which allowed measurements directly in the brain and thus improved algorithms for elimination of the extracranial signals. The investigators aim to determine baseline values and performance of the new device (RheoPatch) compared with a more established NIRS device (NIRO-200NX, Hamamatsu Phototonics, Hamamatsu City, Japan)

Primary objective is to compare the RheoPatch NIRS device with the NIRO-200NX NIRS device in volunteers at rest in supine position. As secondary objectives, repeatability of the measurements will be tested with optode reapplications. With measurements in Trendelenburg position, the investigators evaluate the influence of body (head) position on the NIRS signals.

Primary outcome are the baseline values of cerebral oxygenation levels measured by RheoPatch (SbtO2 (%)) and NIRO-200NX (Tissue oxygenation index: TOI (%)).

Secondary endpoints are the repeatability of the measurements with sensor reapplications (coefficient of repeatability, 5 repeats with each device) and changes of the measurements of cerebral oxygenation saturation level in the Trendelenburg position.

Measurements of baseline cerebral oxygenation values are obtained in supine position with 10 measurements, alternating between devices. Combined with 5 min measurement phase for equilibration and power adjustment, this will require 33 minutes per participant.

Eligibility Criteria:
Inclusion Criteria:

Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:

* Informed Consent signed by the subject
* Subjective good health

Exclusion Criteria:

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject

* Age (\<18, \> 65 yrs.)
* Forehead skin disease
* Allergy to skin contacting components of NIRS-sensors
* Known cerebrovascular and heart diseases