cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Tolerability of Toremifene or Tamoxifen Therapy in Premenopausal Estrogen and Progesterone Receptor Positive Breast Cancer Patients

In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated derivative of tamoxifen, but with a superior risk-benefit profile. In this trial, we sought to compare the efficacy and tolerability of toremifene and tamoxifen therapy in premenopausal patients with operable,estrogen and/or progesterone receptor positive breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Breast cancer
* Received standard treatment (chemotherapy, operation, or radiotherapy)
* premenopausal
* estrogen and/or progesterone receptor positive

Exclusion Criteria:

* Metastatic tumors
* During pregnancy or lactation
American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients

Among the symptoms referred by cancer patients, cancer related fatigue (CRF) is one of the most disabling symptom with a relevant impact on the quality of life.

CRF can occur before, during and after anti-cancer treatment. The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in breast cancer women receiving adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

Cancer related fatigue (CRF) can occur before, during and after anti-cancer treatment. In fact, up to 40% of patients report fatigue at diagnosis, 80%-90% during chemotherapy and radiotherapy, respectively and 20%-50% in the post-treatment phase.

All cancer patients should be screened for the presence of CRF at the first oncological visit and subsequently during and after the anticancer therapies.

If the patient refers CRF, it could be quantified with one of the validate instruments available; the possible determinants could be identified and corrected if possible, to reduce their impact on patients CR.

The most evaluated pharmacological treatments of CRF include psychostimulants (methylphenidate, modafinil, armodafinil) and dexamethasone. Non-pharmacological treatments include physical exercise, psychological therapies and complementary therapies such as agopuncture, yoga, ginseng.

The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in a homogeneous population of breast cancer women submitted to adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

Eligibility Criteria:
Inclusion Criteria:

* submitted for the first time to adjuvant chemotherapy with anthracyclines and cyclophosphamide after surgery for breast cancer;
* not presenting CRF or at least with o al massimo CRF lieve (NRS \< 4);
* 18 year old, who have given written informermed consent;
* who accept to use adequate contraceptive methods, if they are of child-bearing potential.

Exclusion Criteria:

* previously submitted to chemotherapy;
* with concomitant not-correctable alterations, present before chemotherapy, possible determinants of fatigue (NRS ≥ 4), such as anemia, not well controlled pain, insomnia, electrolyte imbalance, dehydration, anorexia/cachexia, hepatic, renal or heart failure, adrenocortical failure, neurological deficit, hypothyroidism, not-controlled diabetes mellitus;
* submitted to raitherapy during the 15 days before the randomization;
* presenting moderate-severe fatigue (NRS ≥ 4) at basaline;
* receivind opioids or corticosteroids (except if admimistered at phisiological doses or to prevent emesis on the chemotherapy day);
* with with blood cell count \< 3000/mm3, platelets \< 70000 mm3, hemoglobin \< 8 g/dL;
* unable to understand the procedures of the study or to collaborate with them;
* pregnant or breastfeeding.
A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium

The purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.

The efficacy and safety of E0671 in combination with Rabeprazole Sodium (i.e., 10 mg/day of rabeprazole sodium and 150 mg/day of E0671) will be investigated in patients with gastric ulcer in a multicenter, randomized, double-blind, parallel-group comparative study using a placebo control group (10 mg/day of rabeprazole sodium and placebo for E0671).

Eligibility Criteria:
Inclusion criteria:

1. Patients with gastric ulcer (A1-and A2-stage)
2. Patients with gastric ulcer who meet all of the following items. Gender and treatment class (in-patient or out-patient) are not asked.

   * Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification).
   * Patients who are not younger than 20 years of age at the time of obtaining informed consent.
   * Patients who meet any of the following conditions:

     * H. pylori-negative
     * H. pylori-positive and not requiring eradication therapy
     * H. pylori-positive and unsuccessful eradication
3. Patients who are given a full explanation about the study objective and design, and able to give prior consent for study participation.

Exclusion criteria:

1. Patients with a complication of duodenal ulcer (excluding cicatrix).
2. Patients with reflux esophagitis
3. Patients with acute gastric mucosal lesions (AGML).
4. Patients with NSAID-induced ulcer.
5. Patients with linear ulcer.
6. Patients with ulcer injured by endoscopy.
7. Patients who underwent gastrectomy or vagal nerve resection.
8. Patients who are not applied to pharmacotherapy, i.e., perforation, pyloric stenosis, major bleeding (exposed blood vessels in the base of ulcer), etc.
9. Patients receiving proton pump inhibitor (PPI) and/or teprenone preparation(s) within 1 week prior to the study administration.
10. Patients with serious cardiovascular diseases (e.g., angina pectoris, heart failure, acute myocardial ischemia, severe tachyarrhythmia), serious hematological disorders (e.g., aplastic anemia), serious renal disorders (e.g., acute, chronic renal failure), serious hepatic disorders (e.g., cirrhosis, severe hepatitis), serious pancreatic disorders (e.g., severe pancreatitis), serious psychoneuroses (e.g., schizophrenia, alcoholic dependency, drug dependency, severe depression), or cancer.
11. Patients with a current or a history of drug allergy to teprenone preparation(s).
12. Patients with a current or a history of drug allergy to PPI.
13. Patients requiring antacid(s) containing digoxin or aluminum hydroxide/magnesium hydroxide that are suspected to exert drug interaction with rabeprazole sodium.
The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.

Exclusion Criteria:

* Previous/current treatment and medical history.
Lower Limb Performance, Balance and Coordination Differences Between the Muay Thai Athletes and Recreational Bodybuilders

Purpose: The aim of this study was to compare balance, coordination and lower extremity functional performances of Muay Thai (MT) athletes and bodybuilders (BB).

Method: Seventeen athletes (14 men and 3 women; mean age: 20.65 + 2.34) engaged in MT and 18 (13 men and 5 women, mean age: 25.89 + 4.83) engaged in BB were included in the study. The Flamingo Balance Test and Y Balance Test were used to evaluate static and dynamic balance, respectively. Coordination was assessed using the Hexagon Test. Lower extremity functional performance was evaluated using the Single Leg Hop Test.


Eligibility Criteria:
Inclusion Criteria:

* age between 18-35 years
* Making MT and BB at least for 5 year as a professional athletes
* currently free of any lower limb injuries within the last three months
* no previous history of injury or surgery that may affect their lower limbs

Exclusion Criteria:

* trained less than 3 sessions per week
* having lower limb injury for more than 1 month
* having a history of surgery, or chronic and progressive disease in their lower limb
* having scoliosis or any other orthopaedic or neurological problems
Changes of Biomarkers in Response to Training and Antioxidant Treatment

The aim of the study is to compare the effects of an intensive 4 weeks exercise training program with or without additional treatment with antioxidants. 16 volunteers are included into the study and randomized into a treatment (n=8,Vitamine E 400 IU od + vitamine C 1g twice daily) and a non-treatment (n=8, training only) group. Before and after the training program, skeletal muscle biopsies will be taken to measure PGC-1alpha and PPARgamma mRNA expression. In addition before and after the training program individuals will have the following measurements: body weight, waist circumference, body fat content (DEXA scan), euglycemic-hyperinsulinemic clamps, ergospirometer (VO2 max), routine laboratory measurements, serum malondialdehyde concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to swallow tablets
* signed informed consent
* no concommitant medication
* male
* age between 25 - 35 years

Exclusion Criteria:

* drug, tobacco or alcohol abuse
* any chronic disease
* any acute or chronic inflammatory disease as determined by a leucocyte count \> 7000 Gpt/l, C-reactive protein (CrP) \> 5.0 mg/dl or clinical signs of infection
* systolic blood pressure (SBP) \> 140mmHg and diastolic blood pressure (DBP) was \> 85mmHg
* cardiovascular or peripheral artery disease
* thyroid dysfunction
Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia

Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.

Overall, 232 patients with acute DILI with hyperbilirubinemia will be enrolled. They will be randomly assigned at a ratio of 1:1 to the conventional treatment alone or combined with glucocorticoids groups. The primary endpoint is the improvement of DILI after treatment on second week. Secondary endpoints include the improvement of DILI on fourth week, rates of progressive liver injury, liver failure, liver transplantation, survival, and adverse events. Exploratory endpoints will assess the beneficial population and changes of inflammatory factors following glucocorticoid treatment.

Eligibility Criteria:
Inclusion Criteria:

* A definite diagnosis of acute DILI;
* 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
* Age 18-80 years old;
* Sign the informed consent form.

Exclusion Criteria:

* Other causes of liver injury, including viral hepatitis, cytomegalovirus infection, Epstein-Barr virus infection, Herpes virus infection, autoimmune liver disease, alcoholic liver disease, hypoxic/ischemic liver disease, Budd-Chiari syndrome, biliary tract disease, Wilson's disease, hemochromatosis, and α1-antitrypsin deficiency;
* Immune checkpoint inhibitors or gynura segetum induced DILI;
* Absolute contraindications to glucocorticoids, such as systemic mold infections or allergies;
* A history of glucocorticoid therapy within 3 months before enrollment;
* A history of diseases requiring glucocorticoid maintenance therapy, such as rheumatoid arthritis, systemic lupus erythematosus, systemic dermatomyositis, etc;
* A history of liver transplantation;
* Received artificial liver therapy before enrollment;
* Malignant tumor of the liver, bile duct, pancreas or liver metastasis
* Acute liver failure;
* Renal dysfunction, creatinine Cr≥133μmol/L;
* Neutrophil count \<1,000,000,000/L;
* Active tuberculosis;
* Severe cardiopulmonary diseases;
* Recent surgery or trauma;
* Mental illness;
* Pregnancy or lactation;
* Participated in other clinical studies within 3 months before enrollment;
* Other conditions judged by the clinician to be inappropriate for study participation.
Assertive Community Treatment (ACT) in Schizophrenia Spectrum Disorders

The study examined the 12-month effectiveness of continuous therapeutic assertive community treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with quetiapine IR.

Two catchment areas in Hamburg, Germany with similar population size and health care structures were assigned to offer 12-month ACT (\& IC; Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf) or SC (Asklepios Hospital, Department of Psychiatry and Psychotherapy) to 120 first-episode and negatively selected multiple-episode patients with SSD. Primary outcome was the time to Service Disengagement. Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, satisfaction with care from patients and relatives perspectives, and service use data.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Met the diagnostic criteria of a first- or multiple episode of a schizophrenia spectrum disorders, i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder NOS
* New initiation or current treatment with quetiapine Immediate Release (IR)

Exclusion Criteria:

* Other psychotic disorders (e.g., due to medical condition)
* Mental retardation (IQ lower than 70 points)
Assessment of the Behavior of the Preterm Newborns

The project presented here aims to evaluate the discrimination capacity of the Observation of Sensory-Motor Behavior (OSMB) grid of the preterm infant, as well as its predictive capacity for the child's later psychomotor development.

To do this, OSMB grids will be completed during dystimulant care and during stabilizing care in 65 preterm infants. In addition, an OSMB grid will also be completed during a sensorimotor assessment at 37 weeks gestational age and at 1 month corrected for prematurity in 100 preterm infants. The OCSM scores will then be compared to the Bayley III scale scores at 6 months of age corrected for prematurity.

The project presented here aims to evaluate the discrimination capacity of the Observation of Sensory-Motor Behavior (OSMB) grid of the preterm infant, as well as its predictive capacity for the child's later psychomotor development.

To do this, OSMB grids will be completed during dystimulant care and during stabilizing care in 65 preterm infants. In addition, an OSMB grid will also be completed during a sensorimotor assessment at 37 weeks gestational age and at 1 month corrected for prematurity in 100 preterm infants. The OCSM scores will then be compared to the Bayley III scale scores at 6 months of age corrected for prematurity.

Eligibility Criteria:
Inclusion Criteria:

* \<37weeks
* Hospitalized in Geneva Hospital NICU
* At least one parent speaking french

Exclusion Criteria:

* No exclusion cirteria
Evaluation of Efficacy and Safety of SPARC1401 in Acute Low Back Pain

A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three dose levels in patients with acute low back pain


Eligibility Criteria:
Inclusion Criteria:

* Gives informed and written consent and is able to comply with all study assessments scheduled in the protocol
* Males or females aged 18 to 80 years (inclusive).
* Female subjects should be surgically sterile (bilateral tubal ligation at least 6 months prior to randomization, bilateral oophorectomy or hysterectomy performed) or if they are of child-bearing potential, should be willing to practice an acceptable method of birth control from screening to completion of study.
* Subjects will be considered eligible for this trial based on medical evaluation, electrocardiogram and laboratory values at screening, and laboratory values outside normal range considered of no clinical significance by the investigator

Exclusion Criteria:

* History or presence of clinically significant or uncontrolled cardiovascular, respiratory, neurological, psychiatric, hepatic, renal, gastrointestinal, hematological, or sleep disorder
* History or clinical signs or symptoms suggestive of stenosing peptic ulcer, pyloroduodenal obstruction, or inflammatory bowel disease
* History of diagnosis of cancer within 5 years prior to screening
* History of narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder-neck obstruction
Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate

The primary working hypothesis of this study is whether wrist arthrodesis leads to an improvement in functional status in both rheumatoid arthritis and post-traumatic osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire no earlier than 1 year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-90
* Wrist fusion took place between 2014 and 2022 using Aptus 2.5 TriLock Total Wrist Fusion Plate, Medartis at Hospital Waldfriede
* rheumatoid Arthritis
* post-traumatic osteoarthritis patterns: 1. scapholunate advanced collapse (SLAC) or 2. scaphoid nonunion advanced collapse (SNAC)

Exclusion Criteria:

* post surgery bone fracture of the same limb
* Pregnancy, lactation
* active malignant tumor
Interleukin-4 (IL-4) as a Marker of Atherosclerosis

In recent years, medical research into the cause and progression of heart disease due to narrowing and blockage of blood vessels to the heart muscle has improved the understanding of ischemic heart disease. It is now accepted that both the development and later progression with sudden blockage of blood vessels are associated with inflammation, although it remains unknown exactly what triggers this inflammatory process. It is possible that new blood tests which measure markers of inflammation in the bloodstream may be useful to help identify patients at risk of heart damage and assess response to treatment.

The study plans to assess a new blood test for a known marker of inflammation (IL-4) in patients with heart disease.

The hypothesis of this study is that, the cytokine, IL-4, measured by a new assay, is abnormally elevated in the blood of patients with coronary artery disease.

Also hypothesized is that the degree of abnormality of blood IL-4, is related to important clinical events in such patients, including severity of disease, acute complications, and treatment.

This is a single centre, prospective, non randomised, non controlled, pilot study of the potential abnormality of a new test group of patients in whom the results are postulated to be abnormal.

The specific aims of the study are:

1. To measure IL-4 by a new rapid on-site technique in patients with documented coronary artery disease presenting in a variety of acute clinical circumstances
2. To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complication and newly prescribed medications.

It is proposed to study 4 small groups of patients with ischemic heart disease.

1. Patients with unstable coronary artery disease admitted to the Coronary Care Unit. They will be studied on admission and then daily until coronary angiography is performed.
2. Patients having coronary angioplasty. They will be studied before, immediately after and 24 hours after the procedure.
3. Patients having coronary artery bypass grafting will be studied immediately after and 24 hours post surgery.
4. Patients with stable coronary artery disease about to receive a statin and or angiotensin-converting enzyme inhibitor therapy will be studied before and twice weekly after commencement of therapy for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All patients (either sex and any age) presenting in the settings described will be eligible to participate.

Exclusion Criteria:

* An unwillingness to participate.
Geolocation Positional System (GPS) Experience

The purpose of this study is to use smartphone technology to capture individual location emotional and cognitive data, to examine how real-world behaviors thoughts, emotions, and brain activity are related to one another.

The observational portion of this study was initially approved in 2015, this is a subset of the initially approved study and it is a clinical trial of 100 participants.

Eligibility Criteria:
Inclusion Criteria:

* Must agree to give informed consent
* Must be willing to have an functional Magnetic Resonance Imaging (FMRI) scan
* Must be able to receive and respond to daily text messages assessing current emotion
* Must be willing to download and run a GPS tracking application (FollowMee) onto their smartphone for a four-month period

Exclusion Criteria:

* history of head trauma, seizures, or neurological disorders
* severe/unstable medical conditions
* conditions that interfere with MRI
* pregnancy
* lifetime psychotic/bipolar disorder
* chronic/severe substance or alcohol abuse/dependence
* antipsychotic medication
IPACK Block in Total Knee Arthroplasty

100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for total knee arthroplasty

Exclusion Criteria:

* Previous operation on same knee
* Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol
* BMI above 32
* Serious psychiatric, mental and cognitive disorders
* Language barrier
* Block failure
* Chronic opioid, gabapentinoid use
* Severe kidney disfunction