cyrilzakka/clinical-trials huggingface dataset:
Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever. Three hundred patients at Patan Hospital will be enrolled in the study. Patients will be assigned to one of the two treatments by chance and followed for 6 months. The two treatment groups will be compared to see which treatment is more likely to make the patient better.

With the study hypothesis that Gatifloxacin is superior to Ceftriaxone in terms of treatment failure in patients with enteric fever, a comparative study will be conducted at Patan Hospital. 300 patients who are diagnosed with enteric fever will be enrolled into the study. The patients will be randomized to one of two groups. One group will receive treatment with Gatifloxacin for 7 days, and the other with Ceftriaxone. The patients will be followed during the treatment courses and at several points of 6 months after initial presentation. The endpoints then will be compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or culture proven enteric fever
* \>= 2 \<= 45 years of age
* Fever \>= 38°C for \>= 4 days
* Informed consent to participate in the study

Exclusion Criteria:

* Pregnancy
* Obtundation
* Shock
* Visible jaundice
* Presence of signs of gastrointestinal bleeding
* Evidence of severe disease
* Diabetes
* History of hypersensitivity to either of the trial drugs
* Known previous treatment with a quinolone antibiotic or 3rd generation cephalosporin or macrolide within one week of hospital admission.
Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness

Volume expansion is one of the main treatments for shock. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary.PEEP test would be an easy alternative to the tests used in current practice.

Volume expansion is one of the main treatments for shock, with the goal of increasing cardiac preload and, consequently, cardiac output. However, this increase only occurs if there is a preload-dependence of cardiac output, which is present in 50% of cases. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary. The end-expiratory pressure test (PEEP) would be to vary the PEEP in patients in shock conditions placed under mechanical ventilation. PEEP is the positive pressure maintained in the airways at the end of expiration. It opposes systemic venous return and lowers cardiac preload. It also distends the pulmonary vessels, increases their resistance and opposes the ejection of the right ventricle. The decrease in PEEP could alleviate the obstacle to venous return and thus increase cardiac preload, mimicking a volume expansion, increasing cardiac output only in the case of preload dependence. This test would be an easy alternative to the tests used in current practice. To evaluate the ability of the PEEP test to detect a preload-dependence condition, defined by a passive passive leg raising test, in patients in shock.

The primary endpoint will be the area under the receiver operating characteristic (ROC) curve constructed to describe the ability of the PEEP test to detect a preload-dependency condition. We measure cardiac output by analysis of the pulse wave contour before and after the passive leg raising and PEEP test tests, then according to these tests, measurement of the cardiac output before and after volume expansion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

  * Coverage by a health insurance scheme
  * Patient under mechanical invasive ventilation (tracheal intubation)
  * PEEP level ≥10 cmH2O
  * Cardiac flow monitoring device in place by the PiCCO2 system (Pulsion Medical Systems, Feldkirch, Germany).
  * Decision by the doctors in charge of carrying out a passive leg raising test and / or a volume expansion

Exclusion Criteria:

* Pregnancy
* Participation in another interventional study
* Patients under the protection of justice
* Thoracic drainage (preventing PEP changes from inducing intrathoracic and transpulmonary pressure changes from their hemodynamic effects).
The Effect of Tamoxifen on Clinical Outcome in Women With Thin Endometrium Undergoing Frozen Thawed Cycle.

Cryopreservation of embryos created during fresh IVF cycles provides a less expensive and time-intensive opportunity for pregnancy. Ideal endometrium thickness is the key point to optimization FET cycle. Researches show that when endometrial thickness is less than 7mm, pregnancy rate dropped significantly. Tamoxifen has been reported to be oestrogenic on the lower genital tract. Several study on intrauterine insemination or ovulation induction suggest that tamoxifen may be a promising alternative for patients with thin endometrium. Based on this ,we want to evaluate the effects of tamoxifen on endometrial thickness and pregnancy outcome in women who failed to develop an adequate endometrial thickness in previous frozen embryo transfer cycle twice or even more times and willing to have another attempt.

Objective: To investigate the effects of tamoxifen on endometrial thickness and pregnancy outcome in women with thin endometrium undergoing frozen thawed cycle.

Study design: This is a single center, randomize control clinical trial. We plan to recruit 100 patients from Mar 2017 to Dec 2019, who failed to develop an adequate endometrial thickness in previous frozen embryo transfer cycle twice or even more times and willing to have another attempt, dividing into two group, one prepare the endometrium through ovulation induction with tamoxifen and progesterone(Study Group), the other is hormone replacement cycle (control group).

Intervention: Study Group will give endometrial preparation with tamoxifen and progesterone, control group will prepared with estrogen and progesterone supplementation.

Main outcome measures: The primary outcome of the study was endometrium thickness and clinical pregnancy rate, the secondary outcomes are cycle duration, cycle cancellation rate, implantation rate, miscarriage rate, live birth rate.

Eligibility Criteria:
Inclusion Criteria:

1. Women age ≥20 years and ≤40 years;
2. patients that have at least 1 high quality blastocysts;
3. patients who are observed endometrial thickness ≤ 7mm in the past natural cycles or hormone replacement cycles repeatedly (twice or even more);
4. patients intends to continue to attempt another frozen embryo transfer cycle.

Exclusion Criteria:

1. patients diagnosed intrauterine adhesions, uterine scarring diverticulum via Hysteroscopy or ultrasonography and have history of uterine cavity operation for the above indication;
2. patients have congenital uterine anomalies such as Gemini, the mediastinum in the uterus and so on.
Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Fasting blood low density lipoprotein cholesterol level as defined by the protocol
* Diagnosed carotid arterial stenosis

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Heavy or total occlusion of the carotid artery or recent stroke
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse
Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions

This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
* Lesions of 20 mm and larger.
* All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
* Patients who were able to provide written informed consent

Exclusion Criteria:

* Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
* Lesions with a wide Paris 0-Is component (\>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
* Pedunculated polyps
* Active/quiescent colitis
* Rectal lesions
* Residual or recurrent adenoma after endoscopic mucosal resection
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 \[NCT01465997\]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.


Eligibility Criteria:
Inclusion Criteria:

* An Institutional Review Board /Institutional Ethics Committee approved written Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
* Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator
* Subject has completed the Termination Visit of SP0994 \[NCT01465997\] and has been treated with lacosamide monotherapy

Exclusion Criteria:

* Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
* Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during SP0994
* Subject required another Anti Epileptic Drug (AED) for the treatment of seizures
* Subject meets a "must" withdrawal criteria for SP0994
* Subject is experiencing an ongoing Serious Adverse Event from SP0994
* Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception, unless sexually abstinent, for the duration of the study
Efficiency and Efficacy of the Distress Thermometer in the Burn and Wound Population (Research Mentoring High Student Project)

The purpose of the study is to test the efficiency and efficacy of the Distress Thermometer of patients admitted to the tertiary Burn and Wound Center. The American Cancer Society and the National Comprehensive Cancer Network published treatment guidelines in 2005 adopting the use of the Distress Thermometer as the preferred adjunct assessment tool of a patient's emotional well-being. A literature search provided extension of the tool to a Cardiac Follow-up Clinic. The Distress Thermometer is currently used with oncology patients at Saint Elizabeth.

The emotional well being of patients and their significant others is a hallmark of wholistic care. The simple Likert scale of 0-10 has a trigger for further assessment and/ or intervention at four. The validity testing of the tool was done against the Hospital Anxiety and Depression Scale (HADS) and the Brief Symptom Inventory (BSI-18).

The purpose of this study is to measure the efficiency and efficacy of the documentation of the Distress Thermometer to patients admitted to a tertiary Burn and Wound Care Center. The frequency of the documentation will be counted and type of documentation will be categorized.


Eligibility Criteria:
Inclusion Criteria:

* nursing staff will be nurses working the evening/night shift beginning at 1900.

Exclusion Criteria:

* all patients on the ventilator.
A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure

The purpose of this study is to evaluate the safety and blood pressure lowering effect of different doses of PF-00489791 in patients with mild to moderate high blood pressure


Eligibility Criteria:
Inclusion Criteria:

1. Males and/or Females of non-childbearing potential between 18 and 70 years of age
2. History of mild to moderate hypertension

Exclusion Criteria:

1. Type 1 or 2 diabetes on prescribed medications
2. Secondary, severe, or malignant hypertension
3. History of a significant cardiovascular event within the last 12 months of enrollment
Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children.

Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic strategies allow healing of over 80% of children. However these treatments are associated with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during treatment initiation, are the thromboembolic complications.

The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no efficacy in the prevention of these thromboembolic complications. Therefore most authors consider that a multifactorial mechanism is behind these events, involving both treatment and malignant cells. The interaction of these two factors participate in the damage of the vascular endothelium.

The microparticles are membrane fragments derived from budding from the membrane of activated cells or apoptosis. Their thrombogenic role is linked to the expression of coagulation activators such as tissue factor. It is also associated with their role in the modulation of signaling pathways involved in the invasiveness and angiogenesis in endothelial cells.

In acute lymphoblastic leukemia, the presence and role of microparticles have not been studied. Our hypothesis is that of production of microparticles upon lysis of blasts then upon activation of endothelial cells induced by the induction therapy, participating in a procoagulant phenotype.

The aims of this study are

* quantify the microparticles in children receiving induction therapy for Acute lymphoblastic leukemia at diagnosis and during treatment
* study the origin of these particles and the expression and activity of the tissue factor on their surface, at diagnosis and during treatment

Eligibility Criteria:
Inclusion Criteria:

* children with acute lymphoblastic leukemia
* children and their parents consenting to participate to the study
* children enrolled in the national healthcare insurance program
Clinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children

This study aimed to evaluate the clinical and radiographic outcomes of photobiomodulation pulpotomy compared to MTA pulpotomy in primary molars in children.


Eligibility Criteria:
Inclusion Criteria:

* Children with dental behavior score of 3 or 4 according to the Frankel behavior rating scale.
* Patients whom their maxillary primary molars are indicated for pulpotomy and SSC restoration.
* Lack of history of allergy to the materials used for anesthesia and sulfite.
* Children free of any systemic disease or special health care needs (ASA 1).
* Completion of the written informed consent form by parents/guardian.

Exclusion Criteria:

* Children who receive any analgesic drugs at least 24 hours before treatment.
* Any inflammation or lesion in the injection site
* Patients who have previous bad experience of dentistry were excluded to eliminate the possible impact of the child's previous painful or stressful experiences
* Child coming for emergency treatment of pain.
* If hemostasis is not achieved within five minutes after application of moist cotton pellet directly to the pulp stumps
* If radicular pulp tissue was not vital due to the presence of suppuration or purulent necrosis (pus discharge).
Topical Hydromorphone for Wound Healing

The hypothesis is that topical opioids will hasten wound healing in humans.

This is based on our published data that morphine is a powerful stimulant of angiogenesis and our preclinical study of wounds in rats which demonstrate that topical opioids (morphine, hydromorphone and fentanyl) hasten healing of punch biopsy wounds. This study will focus on hydromorphone which was more powerful than morphine as a wound-healer in the rat study.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as normal, healthy volunteers age 18-65.

Exclusion Criteria:

* Known bleeding disorder.
Home-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence

This 12-week, exercise study will assess the feasibility of a home-based high-intensity interval training (HIIT) program among colorectal cancer survivors and explore the impact of home-based HIIT compared to a standard home-based moderate-intensity continuous aerobic exercise program on physical outcomes linked with survival from colorectal cancer and surrogate blood markers of colorectal cancer recurrence.

HIIT is a type of aerobic exercise that includes short bursts (i.e. 1-4 minutes) of vigorous exercise followed by longer periods of moderate to lower intensity exercise (i.e. 1-10 minutes). Participants in this study will be randomly assigned into a personalized home based exercise program - either high-intensity interval training (HIIT) or moderate-intensity continuous aerobic exercise (MICE).

This pilot study will provide us with preliminary evidence for a larger trial aimed to compare the effectiveness of these two different types of home-based exercise programs on physical outcomes linked with survival, quality of life, and surrogate blood markers of colorectal cancer recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are no more than five years post resection and/or adjuvant therapy for stage II-III Colorectal cancer (CRC).
2. Age 19-75 years old.
3. Engaging in less than 90 minutes per week of structured moderate- or vigorous-intensity aerobic exercise in the past three months
4. No known cardiovascular, metabolic or renal disease, and no signs/symptoms suggestive of cardiovascular, metabolic, or renal disease.
5. Must be able to read, speak and understand English
6. Willing to complete two assessment sessions (at baseline and 12 weeks).
7. Willing to engage in moderate- or vigorous-intensity aerobic exercise at home and use mobile health technology to track exercise adherence to the exercise prescription.
8. Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
9. Have regular access to a smart phone and willing to download a free application for device tracking

Exclusion Criteria:

1. Functional limitations requiring a walker, scooter, or wheelchair.
2. Clinically evident recurrent disease.
3. Resting blood pressure ≥140/90 at the time of baseline testing.
4. No access to smart phone and/or not willing download the device app
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant

This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis that qualifies them for UCBT
* Adequate organ function
* Availability of eligible donor material

Exclusion Criteria:

* Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
* Human immunodeficiency virus (HIV) infection
* Active infection
Bone Mass Accrual in Children With Autism Spectrum Disorder

This is a observational study to investigate the degree to which bone mineral density is impaired in boys with autism compared with typically developing controls.

Studies have shown that bone cortical thickness is decreased in children with autism and other developmental disabilities. However it is not known whether bone mineral density (BMD) of these children is lower; neither is it known whether there is any correlation between BMD and the child's diet. The overall goal of this study is to improve the long term health of children and adolescents with autism spectrum disorder; more specifically the investigators aim to develop a pilot study to investigate the degree to which BMD is impaired in boys with autism and to explore specific additional risk factors. In addition, the aim is to investigate the degree to which BMD is impaired in boys with Autism Spectrum Disorder (ASD) and to explore specific contributing risk factors including nutritional analysis.

Eligibility Criteria:
Inclusion Criteria:

* Boys 8-17 years chronological age
* BMI between the 3rd and 97th percentiles
* Meets DSM-IV criteria for Autism Spectrum Disorder (ASD group)
* Scores \<15 on the Social Communication Questionnaire (control group)

Exclusion Criteria:

* Use of medications directly affecting bone metabolism including estrogen/ progesterone preparations and glucocorticoids except local application of glucocorticoid
* Use of anticonvulsants which affect bone density including diphenylhydantoin, phenobarbital, topiramate carbamazepine and valproic acid and also use of lithium
* Children with diseases known to affect bone mineral density including Crohn's disease, celiac, thyroid and renal
* Children who will not tolerate lying still for 30 seconds