cyrilzakka/clinical-trials huggingface dataset:
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m\^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m\^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m\^2 po bid on Days 1-7, oxaliplatin 85 mg/m\^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic or inoperable locally advanced colorectal cancer
* \>=1 measurable target lesion

Exclusion Criteria:

* Previous systemic therapy for advanced or metastatic disease
* Previous treatment with bevacizumab
Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome

AUDs are difficult to treat, and relapse rates are high, with an estimated 80% of individuals with AUDs returning to alcohol use after completing addictions treatment. Novel treatment approaches are needed to enhance long term sobriety. The investigator's research team has been investigating the use of acamprosate to prevent relapse to alcohol use. Unfortunately despite being FDA approved and endorsed by the American Psychiatric Association only 10% of patients treated for AUD are prescribed acamprosate or other antidipsotropic medications. The number is higher for patients treated in programs affiliated with Mayo Clinic Addiction Services (approximately 20%) but is way less than expected. The most common reasons behind these low numbers are the understanding that not every patient benefits from the use of specific medication and the lack of biomarkers predictive of response. The purpose of this project is to identify such biomarkers by discovery of genomic and metabolomic markers associated with response to acamprosate treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to85; DSM-5 diagnosis of AUD determined by PRISM;
2. Completion of alcohol detoxification (CIWA score \< 5) and no alcohol for at least 7 days (but no more than 35 days);
3. Ability to provide informed consent
4. Ability to speak English
5. Willingness to use the study medications for 3 months and attend follow-up visits.
6. No chronic/daily use of benzodiazepines, opioids, or stimulants for a period of time which is determined by 3 x the medication half-life value (see addendum A) to be completed before the initiation of study medication (acamprosate or placebo).
7. Willingness to discontinue previously prescribed acamprosate for a period of at least 3 days before randomization to study medication (acamprosate or placebo).

Exclusion Criteria:

1. Hypersensitivity or allergy to acamprosate
2. Current use of wellbutrin and not willing to switch to an acceptable antidepressant medication
3. Renal impairment (creatinine level \>1.5 mg/dL);
4. Diagnosis of advanced liver disease indicated in the medical record or by a MELD score of above 10;
5. Women who are pregnant, breastfeeding, or planning to become pregnant during the next year;
6. Primary diagnosis of substance use disorder other than alcohol as determined by PRISM or in medical record review or secondary diagnosis of active (within the past year) benzo/sedative dependence, opioid dependence, stimulant dependence, heroin dependence, and/or cocaine dependence
7. Refusal to abstain from any chronic/daily use of prescribed benzodiazepines, opioids, stimulants, cannabis related medication such as CBD or medical marijuana, during the course of participation.
8. Current use of Naltrexone and not willing to stop and switch to Acamprosate/Placebo
9. Current use of Antabuse.
10. Active suicidal ideation or any unstable medical or psychiatric condition as determined by responses to PRISM or by the investigator.
11. Status of involuntary or court-ordered admission at time of consent.
Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy

The treatment of anemia depends on its cause. Patients with underlying iron-deficient anemia should be treated or referred to a specialist (eg gynecologist, gastroenterologist) for treatment.deficiency anemia are global health problems and common medical conditions seen in everyday clinical practice.

Iron is vital for biological functions, such as breathing, energy production, DNA synthesis, and cell proliferation.

Iron deficiency refers to the reduction of iron stores and precedes the occurrence of iron deficiency anemia.

Iron deficiency anemia is a more severe condition in which low levels of iron are associated with anemia and the presence of small cellular red blood cells.

The diagnosis of anemia is based on the patient's symptoms and blood tests. Blood tests refer to hemoglobin, hematocrit, and the number of red blood cells (per cubic centimeter or millet of blood). Also, the status of iron stores in the body can be measured by measuring ferritin. With these blood tests it can be determined Per os treatment: The dosage of elemental iron required to treat anemia due to iron deficiency in adults is 120 mg per day for three months. An increase in hemoglobin by 1g / dl after one month of treatment shows an adequate response to treatment and confirms the diagnosis. In adults, treatment should be continued for three months after correction of anemia to allow replenishment of iron stores.

Patient noncompliance may be an obstacle to oral therapy due to the occurrence of gastrointestinal side effects such as epigastric discomfort, nausea, diarrhea and constipation. These effects can be reduced when iron is taken with meals but its absorption can be reduced by 40%.

In addition, taking medications such as proton pump inhibitors and agents that reduce gastric acid hypersecretion (eg chronic atrophic gastritis, recent gastrectomy or abdominal incision) reduce iron absorption.

Eligibility Criteria:
Inclusion Criteria:

* 16-90 yers
* Iron deficiency anemia
* Treatment with iron succinylate
* Fatigue symptoms
* Informed Consent
* Compliance with study procedures

Exclusion Criteria:

* Anemia caused by other parameters (non-iron-deficiency)
the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

According to previous studies, IFN-β has strong antiviral activity and also has an acceptable safety profile. Based on possible therapeutic effects, we decided to lead an Investigation into Beneficial Effects of high-dose Interferon Beta 1a, Compared to low-dose Interferon Beta 1a (the base therapeutic regimen) in Moderate to Severe COVID-19.

Previous studies demonstrate that IFN-β 1a could be used against some coronaviruses including avium infectious, bronchitis virus, murine hepatitis virus, and SARS- CoV because they are susceptible in vitro or in vivo. In a current study, the efficacy of IFN-β 1a in COVID-19 patients were evaluated, and they found than IFN-β 1a reduced the disease symptoms.

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed)
* at least one of the following: radiation contactless body temperature ≥37.5, cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission.
* Time of onset of the symptoms should be acute (Days ≤ 14)
* NEWS2 ≥ 1 on admission (National Early Warning Score 2)

Exclusion Criteria:

* Refusal to participate expressed by patient or legally authorized representative if they are present
* Patients using drugs with potential interaction with Lopinavir/Ritonavir or Interferon-β 1a
* Pregnant or lactating women.
* History of alcohol or drug addiction in the past 5 years.
* Blood ALT/AST levels \> 5 times the upper limit of normal on laboratory results.
* The patients who were intubated less than one hours after admission to the hospital
A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)

The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 years or older
* Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least one systemic treatment regimen
* Measurable disease as defined by the 2014 Lugano Classification
* Normal hepatic function or hepatic impairment as defined by the National Cancer Institute Organ Dysfunction Working Group hepatic impairment classification:

  * Arm A Normal hepatic function: bilirubin and aspartate aminotransferase (AST) ≤ upper limit of normal (ULN)
  * Arm B Moderate hepatic impairment: bilirubin \> 1.5 × to 3 × ULN (any AST)
  * Arm C Severe hepatic impairment: bilirubin \> 3 × ULN (any AST)
* ECOG performance status 0 to 2 for participants with normal hepatic function. ECOG 0 to 3 for participants with moderate or severe hepatic impairment
* Adequate organ function
* Women of childbearing potential (WOCBP)\* must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of the first dose until at least 7 months after the last dose of study drug.

Exclusion Criteria:

* Previous therapy with loncastuximab tesirine
* Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1)
* Human immunodeficiency virus (HIV) seropositive
* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
* History of Stevens-Johnson syndrome or toxic epidermal necrolysis
* Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease
* Breastfeeding or pregnant
* Significant medical comorbidities
* Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor
C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients

Transesophageal echocardiography (TEE) is commonly used in operating room (cardiac surgery), as well as in other critical care settings. A recent meta-analysis including only three randomized studies demonstrated that the use of a videolaryngoscope for transesophageal echocardiography probe insertion in anesthetized patients undergoing open cardiac surgery was associated with a significant reduction in the number of attempts. insertion and complications rate, compared with blind insertion or a laryngoscope-assisted insertion.

ICU patients are usually intubated, with multiple complications, requiring high doses of catecholamines, and with frequent coagulation disorders. Many of these patients, during their stay in the ICU, require a transesophageal echocardiogram. On multiple occasions, due to the critical situation of the patients, due to edema, and coagulation alteration, the placement of the echocardiography probe can be difficult, leading to complications, such as gastric bleeding or lesions in the oropharyngeal mucosa.

To avoid complications during the insertion of the TEE tube, the investigators consider it necessary to introduce it in the fewest possible attempts.

The primary aim of the present study was to compare the success rate of TEE probe insertion at the first attempt betweenn the C-MAC videolaryngoscope assisted insertion and the blind insertion technique.

The secondary aim was to compared differences between the 2 groups in the incidence of complications ( oropharyngeal mucosal injury, hematoma, ....), overall success rate, the number of insertion attempts, and the duration of insertions.

One hundred intubated ICU adult patients that require transesophageal echocardiography insertion, will be randomized by means of a computer-generated randomization order into two groups: Conventional group (Group Blind), and videolaryngoscope group (group C-MAC).

Success rate of the selected technique (first attempt), overall success rate, number of attempts, complications, and duration of insertion for technique will be noted.

Eligibility Criteria:
Inclusion Criteria:

* ICU intubated patients that require transesophageal echocardiography probe insertion

Exclusion Criteria:

* patients younger than 18 years and older than 85 years
* oropharengeal infection
* esophageal injury and anatomic abnormalities
* Consent refusal for participating in the trial.
Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder

The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.


Eligibility Criteria:
Inclusion Criteria:

* Primary Diagnosis of GAD (DSM IV, 300.02) as established by the clinician using all sources of data including the MINI structured interview
* HAM A score ³20 at the Screening (Study Day -7) and Baseline (Study Day 1) Visits by observer rating
* Good health as determined by medical history, physical examination, vital signs, electrocardiography (ECG), and clinical laboratory measurements
* Covi Anxiety Scale total score ³9 and Raskin Depression Scale total score £7 at the Screening Visit (to ensure predominance of anxiety symptoms over depression symptoms)
* Age 18 to 65 (inclusive)

Exclusion Criteria:

* Patients with most other current DSM-IV Axis I disorders.
* Patients with current or past schizophrenia, Psychotic disorder
* Delirium, dementia, amnestic, and other clinically significant cognitive disorders
* Bipolar or schizoaffective disorder
* Benzodiazepine abuse or dependence; and/or Factitious disorder.
Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

The study is a pilot study where adolescents 12 - 18 years of age with mild to moderate depression will be randomized to receive either hypericum 250mg twice daily or fluoxetine 10mg daily increased to 20mg daily after 1 week and the option to increase to 40mg daily after 4 weeks. Patients will be treated for a total of 8 weeks. Efficacy will be measured using the CDRS-R, BDI-II and the CGI scales. Safety parameters include blood tests, urinalysis and ECG.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Adolescents aged 12 to 18 years
* Patients meeting the criteria for mild to moderate depression according to the DSM-IV scale
* Physical and laboratory examination at baseline compatible with study criteria
* ECG at baseline compatible with study criteria
* Score of at least 40 on the Children's Depression Rating Scale - Revised (CDRS-R) at baseline

Exclusion Criteria:

* Patients with psychosis, bi-polar disease, schizophrenia or significant developmental disorder
* Patients with epilepsy
* Patients with a history of alcohol or substance abuse in the past year
* Initiation of psychotherapy or behavioral therapy in the 2 months prior to screening or during the study.
* Patients who have previously failed to respond to SSRI's or SRNI's
* Patients who have been treated with antidepressants within 2 weeks of screening (4 weeks if fluoxetine)
* Patients with a contraindication to taking either Remotiv or fluoxetine or taking medication contraindicated when taking Remotiv or fluoxetine
Prevention of Depression in At-Risk Adolescents

This study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression.

Depression is a prevalent, chronic, and impairing condition that is often undetected and becomes more difficult to treat as chronicity increases. There is an increasing need to conduct large-scale depression prevention studies in adolescents. This study evaluates a cognitive-behavioral prevention (CBP) program to determine its effectiveness in preventing depressive disorders in at-risk adolescents. The study also will ascertain the costs this intervention to inform attempts at future dissemination of the program in "real world" settings.

Participants in this study are randomly assigned to receive either CBP for eight weekly and 6 monthly continuation sessions or usual care. Depressive symptoms and disorders, levels of functioning, and medical and mental health care utilization are assessed at baseline and again at 2, 8, 20, and 32 months after intake.

Eligibility Criteria:
Inclusion Criteria:

* A parent has had a depressive disorder during child's life
* Adolescent has had a past depressive episode or has current subsyndromal depressive symptoms measured on the Center for Epidemiological Studies Depression Scale (CES-D)

Exclusion Criteria:

* adolescent or parent ever diagnosed with bipolar I or schizophrenia;
* adolescent has a current DSM-IV mood disorder diagnosis
A Randomized Controlled Trial on the Efficacy and Safety of Butylphthalide in Reducing Myocardial Infarction Size and Improving Outcomes in STEMI Patients After Primary PCI

This study is a prospective, randomized, placebo-double-blind, multicenter clinical trial. The purpose of this study is to investigate whether "butylphthalide +PCI" combined treatment mode on the basis of traditional drug therapy could reduce myocardial infarct size, improve cardiac function and long-term prognosis of patients with acute myocardial infarction, and verify the drug safety of butylphthalide in the treatment of STEMI within the window period of 12 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Age range of 18-75 years, encompassing both genders;
2. Patients presenting with an initial clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI), within a maximum time frame of 12 hours from the onset of pain to consideration for trial inclusion, who fulfill the criteria for percutaneous coronary intervention (PCI) and express their intention to undergo PCI;
3. The subject and their legal representative possess the capacity and willingness to provide informed consent by signing.

Exclusion Criteria:

1. Uncontrolled hypertension (systolic blood pressure≥200mmHg and/or diastolic blood pressure≥110mmHg);
2. Previous PCI or CABG;
3. Long-term use of loading doses of anticoagulant or antiplatelet drugs;
4. History of hemorrhagic stroke or ischemic stroke within 6 months, peptic ulcer, prolonged cardiopulmonary resuscitation (more than 10 minutes) within the last 6 weeks, surgery, or major trauma;
5. Known allergy to butylphthalide or excipients;
6. Patients with any of the following conditions: cardiogenic shock, chronic congestive heart failure NYHA class ≥III, severe hypotension, pulmonary insufficiency, severe hepatic and renal insufficiency;
7. History of congenital or acquired hemorrhagic diseases, coagulation factor deficiency diseases, thrombocytopenic diseases, etc. Or any of the following laboratory tests (INR \> 2.0, platelet count \< 100×109/L, Hb \< 10g/dl);
8. Pregnancy, lactation, and planning to become pregnant within 30 days;
9. Severe mental disorder, alcohol dependence or inability to cooperate with informed consent and follow-up due to dementia;
10. Concurrent malignant tumor or severe systemic disease with expected survival time less than 30 days;
11. Have participated in or are currently participating in another clinical intervention study within 30 days before randomization;
12. Other reasons for not being eligible for the study.
Cancer Control Following Polypectomy

This study evaluates strategies for the surveillance of post-polypectomy patients for the control of bladder cancer


Eligibility Criteria:
Inclusion Criteria:

* referral for colonoscopy or
* referral for proctoscopy or for a complete colonoscopy after a proctoscopy or flexible sigmoidoscopy

Exclusion Criteria:

* prior history of colon cancer, unrelated polypectomy, inflammatory bowel disease, family history of familial polyposis
Optimized Acupuncture Treatment for Female Stress Urinary Incontinence

This multicenter randomized controlled trial is designed to explore a relatively suitable application of acupoint combinations and to provide certain clinical evidence for the optimization of acupuncture treatment of female SUI.

Stress urinary incontinence (SUI) mainly refers to the involuntary leakage of urine when abdominal pressure increases, such as sneezing, coughing, laughing or exercise. According to epidemiological studies, the global median prevalence of female urinary incontinence is 27.6% (4.8%-58.4%), of which SUI accounts for more than 50%. Previous study have demonstrated that acupuncture intervention can reduce the urine leakage in pad test, decrease the ICIQ-SF score, so as to help the patients alleviate the symptoms and improve their quality of life. This multicenter randomized controlled trial set 3 groups. Patients will receive 3 different applications of acupoint combinations so that the optimization of acupuncture treatment of female SUI will be find.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate SUI mentioned in the diagnostic criteria above;
* Aged 40～75 years;
* Sign the informed consent.

Exclusion Criteria:

* Other types of urinary incontinence (urgent, overflow or mixed).
* History of urinary incontinence surgery or pelvic floor surgery;
* Pelvic organ prolapse ≥ stage II;
* Symptomatic urinary tract infection;
* Residual urine volume \> 30 mL;
* Maximum urinary flow rate \< 20ml/s.
* Limitation of movement (walk and/or run and/or climb stairs);
* Patients who have been using drugs that may affect bladder function or receiving SUI specialized treatment;
* Severe cardiovascular, cerebral, liver, kidney and hematopoietic system disease, mental disorders, diabetes, multiple system atrophy, cauda equina neuropathy and spinal cord disease;
* Pregnancy or lactation period.
* With cardiac pacemaker, acupuncture phobia or metal allergies;