cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Chemotherapy for High Malignant Prostate Cancer

This study aims to evaluate the efficacy of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Eligible participants include those diagnosed with prostate cancer confirmed by biopsy or surgical pathology, with a Gleason score of 9-10 or containing a Gleason 5 component, and no evidence of distant metastasis. Patients will be divided into two groups: the standard treatment group receiving only radical treatment (radiotherapy or surgery), and the standard treatment plus chemotherapy group, receiving four to six cycles of docetaxel chemotherapy after standard treatment. The primary endpoint is Failure-Free Survival (FFS), with secondary endpoints including Biochemical Relapse-Free Survival (BRFS), Metastasis-Free Survival (MFS), Overall Survival (OS), and assessment of adverse events The study aims to better understand the impact of adjuvant chemotherapy on the prognosis of patients with high-risk prostate cancer and determine whether it improves survival outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components.
2. No evidence of distant metastasis confirmed by imaging.
3. Expected to receive standard radical treatment or postoperative radiotherapy.
4. Estimated survival time greater than 12 months.
5. Aged ≥ 18 years.
6. Karnofsky Performance Status (KPS) ≥ 80.
7. Adequate blood count: white blood cell ≥ 3.5 × 10\^9/L, neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100.0 × 10\^

Exclusion Criteria:

1. History of malignant tumors (except those cured for more than 5 years).
2. Previous abdominal radiation therapy.
3. Weight loss \> 10% within the past 6 months.
4. Pre-existing or concomitant bleeding disorders.
5. Active infections.
6. Significant cardiovascular disease (e.g., controlled hypertension, unstable angina, NYHA class ≥ II congestive heart failure, unstable symptomatic arrhythmias, or ≥ II peripheral vascular disease) or any condition deemed intolerable to chemotherapy by the oncology department.
Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women

Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, first-generation (born in Japan, living in the US for less than 5 years)
* Japanese female subjects
A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials

The aim of this study is to compare the effectiveness of using heat-activated NiTi with superelastic NiTi archwires during the initial phase of orthodontic treatment.

Primary Objective:

To compare the difference in the amount of crowding in the lower incisors after 4 and 8 weeks from the start of treatment.

Secondary Objectives:

1. To compare the amount of orthodontically-induced inflammatory root resorption (OIIRR) in the apical region of mandibular central incisors between the two groups of archwires
2. To compare the amount of pain perception between the two groups of archwires during the 1st week after each wire placement.

Objectives: To compare the heat-activated nickel titanium (HANT) with superelastic nickel titanium (SENT) archwires in terms of their effectiveness in aligning teeth, possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment.

Subjects and Methods: Orthodontic patient aged 12 years or over with lower anterior crowding of 3-6 mm. who need treatment without extraction, were randomly allocated to the HANT and SENT archwires groups with a 1:1 allocation ratio. Archwire sequence in both groups was 0.014-inch and 0.016-inch, respectively. Each archwire was placed for 4 weeks. Outcome measures included the amount of crowding using Little's irregularity index (LII), apical root resorption, and pain perception. The effectiveness of alignment was tested using 2X2 mixed factorial ANOVA, while root resorption and pain perception were tested by the Mann-Whitney U test, and Wilcoxon signed-rank test (P\<0.05).

Eligibility Criteria:
Inclusion Criteria:

1. Patients indicated for fixed appliance orthodontic treatment who have a moderate crowding (3-6mm) according to the Little's irregularity index (LII).
2. Full set of lower permanent dentition excluding the third molars.
3. No history of trauma or root resorption in the lower incisors.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. Less than 3mm of lower incisor crowding (LII) or with spaced incisors.
3. Severe crowding in the lower arch (greater than 7mm) which requires extraction.
4. Blocked-out teeth that cannot be engaged with the aligning archwire.
5. Patients with periodontally compromised teeth.
Use of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock

Hemorrhagic shock is a pathologic state in which intravascular volume and oxygen delivery are impaired. During circulatory failure associated with hypovolemia and low cardiac output, redistribution of blood flow caused by increased vasoconstriction results in decreased perfusion of the skin.

Skin temperature and capillary refill time has been advocated as a measure of peripheral perfusion.

Perfusion index (PI) is a non-invasive numerical value of peripheral perfusion obtained from pulse oximetry, it is an indicator of the pulse strength at the sensor site. The PI's values range from 0.2% for very weak pulse to 20% for extremely strong pulse according to patient's physiological conditions and monitoring sites.

Large increases in lactate (i.e. \> 5 mmol/L) usually only occur due to hypoperfusion or muscle activity such as exercise or seizures.

This study will investigate the role of nitroglycerine patch in improving the peripheral perfusion in poly traumatized patient with hemorrhagic shock for the first time.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-60 years old. With the patient fully conscious or slightly drowsy.
* Blood pressure: Systolic blood pressure below 90mmhg ,mean blood pressure below70mmhg or decrease of systolic blood pressure 40mmhg below normal value.
* Metabolic acidosis: PH less than 7.35 due to hypoperfusion.
* Capillary refill time \> 4 seconds.
* Normal body core temperature.

Exclusion Criteria:

* Age: below 20 and above 60 years old.
* Head trauma with Glasco coma score below 14 due to increased intracranial pressure (stroke, subarachnoid hemorrhage or brain trauma injury).
* Severe hypotension not responding to fluid therapy.
* Patient with bilateral ischemic arm injury.
* Patient with hepatic cell failure
* Patients admitted to the emergency trauma department after 6 hours of the trauma event.
* Preexisting conditions as severe cardiovascular disease, uncontrolled hemorrhage, failure of central venous catheterization, dialytic procedure anticipated during the study period.
Potentially Inappropriate Prescription Associated to Multimorbidity

A prospective multicenter cohort study in 5 hospitals in Spain will be initiated in 2016.

Objectives:

1. To estimate and describe patterns of multimorbidity and polypharmacy in patients over 64 admitted for a chronic disease exacerbation.
2. To analyze the potentially inappropriate prescribing (PPI) drugs according to STOPP / START (SS) criteria.
3. To evaluate the relationship between multimorbidity and PPI and adverse medication (RAM) preventable reaction.

The cohort will include 800 patients \>64 years admitted in internal medicine and / or geriatric department of 5 hospitals of the National Health Service. Application of the SS criteria (released in 2015) on admission and at discharge, and collection of demographic and clinical variables including comorbidities, baseline chronic medication, geriatric syndromes, functional capacity and RAM. Descriptive analysis and bivariate parametric or nonparametric tests will be applied to analyze relationship between morbidity, polypharmacy, SS criteria and RAM. Intraobserver agreement will be assessed for SS criteria. Multiple regression techniques will be applied, where the dependent variable will be the PPI or the RAM.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the Internal Medicine or Geriatrics department
* Admitted to hospital because of an exacerbation of any previous chronic condition

Exclusion Criteria:

* Terminal ill patients at admission
* Patients with lower forecast life than 1 year
* Patient admitted to the hospital only because an acute problem
* In patient home care
Administration of Arginine Supplementation in Preterm Infants

Calprotectin is a cytosolic component of neutrophils .Fecal calprotectin(FC) is a useful marker for exacerbation of inflammatory bowel disease in children .FC may be a useful marker for necrotizing enterocolitis (NEC).

NEC is one of the most common ,deadliest and enigmatic intestinal problems encountered mostly in premature infants. The precise pathophysiology of NEC is unclear ,but major factors thought to play an important role include an immature intestine ,an inflammatory response to intestinal microbes,enteral feedings and intestinal ischemia-reperfusion injury.Diagnosis of NEC is not easy clinically and up to now there is not a simple laboratory test to differentiate NEC at an early stage from other conditions in the neonate.

Arginine is the substrate for NO production in the gut and its deficiency may cause vasoconstriction and gut injury and thus predispose to NEC. In previous studies arginine supplementation was found to reduce the incidence of NEC in premature infants but more studies are needed for the use of arginine supplementation for the prevention of NEC.

The investigators aim is to measure the fecal calprotectin in very low birth weight (VLBW) infants during the first month of life as an inflammatory marker of the bowel and evaluate whether premature infants receiving arginine supplements had lower calprotectin values compared to the premature infants that did not .

The investigators hypothesize that arginine supplementation in preterm infants reduces the inflammation of the gut which will be shown by the lower fecal calprotectin values of the premature infants receiving arginine supplementation.


Eligibility Criteria:
Inclusion Criteria:

* preterm neonates born at Alexandra hospital during the study period
* \< 34 weeks gestational age
* \< 1500gr birth weight

Exclusion Criteria:

* major congenital abnormalities
* inborn errors of metabolism
* parents not consent
Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450

The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.

This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.

Eligibility Criteria:
Inclusion Criteria

* Overall healthy subjects
* Non-childbearing potential females included

Exclusion Criteria

* Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
* Use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration
* Abnormal screening laboratory results that are considered clinically significant by the investigator
* Pregnant or breastfeeding female; requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
* Previous exposure to ABT-450
Effectiveness of Narrow Margins in Patients With Low-Risk Basal Cell Carcinoma Undergoing Surgery

This clinical trial studies the effectiveness of narrow margins in patients with low-risk basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the area of normal tissue around a tumor taken out during surgery to make sure all of the cancer is removed. This clinical trial studies tissue samples to determine the least amount of tissue that must be removed to give an acceptable cure rate. This may allow less normal tissue to be removed from patients and may be a less expensive surgery.

PRIMARY OBJECTIVES:

I. To determine the success rate of narrow margin excisions of low-risk facial basal cell carcinoma (BCC).

SECONDARY OBJECTIVES:

I. To determine the narrowest excision margin for low-risk facial BCC that gives an acceptable (95%) cure rate over a 3 year follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Location

   1. Area M (cheeks, forehead, scalp \& neck) tumor size \< 10 mm
   2. Area H (central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear) tumor size \< 6 mm
2. Well-defined borders
3. Primary BCC
4. Patient is not immunosuppressed
5. There has not been prior radiotherapy to the site
6. Nodular subtype
7. No perineural involvement-(no neurological deficits grossly) -

Exclusion Criteria:

1. Location

   1. Area M tumor size \> or = to 10 mm
   2. Area H tumor size \> or = to 6 mm
2. Poorly defined borders
3. Recurrent BCC
4. Patient is immunosuppressed
5. There has been prior radiotherapy to the site -
Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection

Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection

Investigators designed an open, two-arm study to compare to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection.

From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Fecal samples are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years With recurrent CDI

Exclusion Criteria:Older than 18 years

-
Interactive Informed Consent and Decision Conflict

Informed consent for surgery can address the legal aspects while also being simple, informative, and empathic. It can help people confirm that the potential harms are acceptable in light of the potential benefits. Standard consent forms just document this process, while a computer-based, interactive consent process can also standardize and potentially enhance it.

It's not clear that the current informed consent process adequately addresses common misconceptions and adequately confirms patient understanding of potential harms and potential benefits. Thoughtful patient consideration of potential benefits and potential harms of surgery might be facilitated by a step-by-step, iterative, interactive electronic consent process designed to help patients: 1) become aware of their values, 2) understand the actual and potential harms of surgery, 3) understand the potential benefits of surgery, and 4) guide people away from common misconceptions and towards decisions based on their values.

Eligibility Criteria:
Inclusion Criteria:

1. English and Spanish-speaking adults
2. Older than 18 years of age
3. One of six common upper extremity conditions including carpal tunnel release, cubital tunnel release, trigger finger release, plate and screw fixation of a distal radius fracture, removal of a benign lump including a ganglion cyst, and Dupuytren contracture release.

Exclusion Criteria:

People with cognitive deficits were excluded.
Acupuncture and Post-Operative Ileus

Postoperative ileus, the transient cessation of normal bowel function, is a universal aspect of colon surgery. Its occurrence may lead to increased patient discomfort and additional time and cost to hospital stay. Evidence from previous studies indicate that acupuncture may be beneficial in decreasing time to recovery of bowel function and decrease the body's inflammatory response. However, this has not been studied in a randomized, prospective fashion in colon surgery. The goal of this study is to determine if acupuncture may be utilized as a therapeutic modality to decrease time to return of bowel function and discharge from the hospital.

The pathogenesis of post-operative ileus is not completely known. It is thought that post-operative ileus involves trauma to the bowel. This traumatizing of the intestine and peritoneal surfaces results in production and release of inflammatory mediators. These in turn, lead to inactivation of inhibitory neural reflexes. There is also an additive effect of opioids used for post-operative pain, aggravating and adding to the duration of post-operative ileus. Acupuncture has shown promise in both human and animal model studies to reduce post-operative nausea and vomiting and post-operative ileus. It is the investigator's hypothesis that acupuncture will minimize or reduce both post-operative ileus and nausea following elective colon surgery and will lead to a decrease in inflammatory markers that are known to be elevated following abdominal surgery.

The study goals are to determine if acupuncture:

* Leads to earlier return of bowel function
* Leads to earlier time to discharge following colon surgery
* Leads to earlier return of colonic motility
* Leads to decreased postoperative nausea and vomiting
* Leads to a decrease in inflammation

Eligibility Criteria:
Inclusion Criteria:

* male or female
* age 18-89
* colorectal pathology requiring standard elective open or laparoscopic colectomy

Exclusion Criteria:

* pregnancy
* pacemaker or implantable electronic devices
* bowel obstruction
* intra-abdominal abscess or sepsis
* colorectal tumors invading other organs or surrounding tissues
* diverticulitis complicated by fistula
* known immunodeficiency disorders
* tumors requiring an anastomosis below 7cm above the anal verge as measured by rigid proctosigmoidoscope exam at surgery
* chronic pain medications
* surgeries requiring temporary or permanent ostomies
* emergent operations
* receiving preoperative radiation/chemotherapy
* major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupunctural treatment areas
the Efficacy and Safety of CLAE in R/R T-ALL/LBL

To evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL.

This study is a prospective, open, multiple -centered, sing-arm trial. The major aim of this studies to evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL. The study will include 50 subjects to receive CLAE regimen for reinduction chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T-acute lymphoblastic leukemia/lymphoblastic lymphoma according to World Health Organization (WHO) criteria which has relapsed or is refractory to chemotherapy.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* The expected survival period is more than 12 weeks.
* At least one measurable nidus
* Adequate organ function defined as:

  * Calculated creatinine clearance ≥ 50 ml/min using the cockcroft -Gault formula
  * AST, ALT, total bilirubin ≤ 2 x upper limit of normal (ULN) except for Gilbert's disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia), in which case ALT and AST may be elevated up to ≤ 5 x ULN.
* Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.

Exclusion Criteria:

* Previous treatment with nelarabine or clofarabine or fludarabine or cladribine was ineffective.
* Pregnant or nursing.
* Received any other investigational agent or systemic cytotoxic chemotherapy within the preceding 2 weeks.
* Active HIV or hepatitis B or C infection.
* Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator's judgment.
ADCC Against Gastric Cancer Cells

Peripheral blood will be taken from the enrolled patients at National University Hospital and from healthy volunteers. ADCC assay will be performed for evaluating efficacy of new medicine candidates.


Eligibility Criteria:
Inclusion Criteria:

For the gastric cancer patients, patients with 21 years of age and above and younger than 80 years old who have gastric cancer can enroll in this study. For the healthy donors, healthy volunteers with 21 years of age and above and younger than 80 years old can enroll in this study.

Exclusion Criteria:

(A) Age of \<21 and \>80 years old (B) Pregnancy (C) Decision of unsuitableness by Principal Investigator or physician-in-charge
Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy

The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months after operation.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesia physical status class I \& II
2. Age ≥ 20 and ≤ 65 years
3. Robot- assisted endoscopic thyroidectomy

Exclusion Criteria:

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
2. Body mass index ≥ 40 kg/m2
3. History of seizure disorder
4. Current therapy with pregabalin, gabapentin, or any opioid
5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
6. Insulin-dependent diabetes mellitus
7. Renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2)