cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma

The purpose of this study is to assess the overall response rate (ORR) of persistent, recurrent or metastatic leiomyosarcoma in patients treated with ARQ 501.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide signed and dated informed consent prior to study-specific screening procedures.
* Histologically or cytologically confirmed leiomyosarcoma that is persistent, recurrent or metastatic.
* Measurable disease as defined by RECIST.
* Karnofsky performance status \>= 70%
* Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of ARQ 501.
* Hemoglobin (Hgb) \>= 10 g/dL.
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (\>= 1,500/mm3).
* Platelet count \>= 100 x 10\^9/L (\>= 100,000/mm3).
* Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than or equal to 3.0 x ULN with metastatic liver disease.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN less than or equal to 5.0 ULN with metastatic liver disease.
* Creatinine less than or equal to 1.5 x ULN.

Exclusion Criteria:

* Received three or more prior anticancer chemotherapy regimens.
* Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
* Have received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or investigational agents within four weeks of first infusion.
* Have symptomatic or untreated central nervous system (CNS) involvement.
* Are pregnant or breastfeeding.
* Previous exposure to ARQ 501.
T-Wave Alternans in Dialysis Patients

Sudden cardiac death due to arrhythmia is the leading cause of death in end-stage renal disease (ESRD) patients treated with hemodialysis (HD). As it is anticipated that the number of individuals with ESRD will exceed 1.2 million in the next 20 years, sudden death in this population has enormous public health impact. Research has shown that arrhythmic events are temporally associated with longer periods between HD with a three-fold risk of events in the 12 hours preceding the longest inter-dialysis interval. The exact cause of these findings is unknown.

The purpose of this study is to assess the degree of cardiac electrical instability at various times in the dialysis cycle. The hypothesis is that longer time intervals between hemodialysis results in sympathetic and electrolyte-induced alterations in ventricular repolarization that can be measured non-invasively using microvolt T-wave alternans (TWA). This increase in cardiac electrical instability may serve as a link between the clinically observed periods of increased risk and the occurrence of sudden cardiac death.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic ESRD who have been on HD for at least 3 months
* Subjects 18 to 90 years of age with one or more risk factors for coronary artery disease or sudden cardiac death, including diabetes, peripheral vascular disease, known coronary artery disease, or ejection fraction \< 40% by any imaging modality.

Exclusion Criteria:

* Subjects unwilling or unable to give written informed consent.
* Patients unable to return for regularly scheduled dialysis treatments
* Atrial fibrillation or flutter at screening
* Major surgical procedure two months prior to enrollment
* High grade heart block or a permanent pacemaker in situ
* Patients with known allergies to adhesive tape
Depression Symptoms Among Ever Married Females Attending Primary Health Care Units in Dairut City

Depression is defined as a cluster of specific symptoms with associated impairment. The clinical and diagnostic features of the disorder are broadly similar in adolescents and adults.

Nevertheless, depression in adolescents is more often missed than it is in adults, possibly because of the prominence of irritability, mood reactivity, and fluctuating symptoms in adolescents.

While depression is the leading cause of disability for both males and females, the burden of depression is 50% higher for females than males. In fact, depression is the leading cause of disease burden for women in both high-income and low- and middle-income countries.

The prevalence of depression in children is low (\<1% in most studies) with no sex differences, and then rises substantially throughout adolescence.

Okasha found that the lifetime prevalence of depression in urban and rural Egyptian populations to be 11.4 and 19.7% Several studies show that depression during adolescence is a risk factor of academic failures, marriage struggles, suicide attempts, interpersonal conflicts, unemployment, drug abuse; it is also a strong predictor of adulthood depression.

Girls married too early are also more likely to experience domestic violence, abuse and forced sexual relations.

Similarly early married females when interact with new individuals after marriage are unable to deal them psychologically which is mostly due to the bad behaviours shown from in-laws towards them thus leading to lower self-esteem, increasing their risk of clinical depression which on extreme aspect can cause suicidal attempts.

Eligibility Criteria:
Inclusion Criteria:

* Married
* Divorced
* Separated
* Widow

Exclusion Criteria:

* Cases diagnosed with mental disorders
* History of mental disorders
* Family history of mental disorders
A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making

The overall goal is to improve shared decision-making (SDM) about treatment options and thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with rheumatoid arthritis (RA). The objective of this study is to engage patients in using the ArthritisPower application on a weekly basis during the time between clinic appointments for collection of data on self-reported disease activity and patient-reported outcomes (PROs), and to display the data using an iPad to the patients and their rheumatology health care providers (HCPs) at the point of care for SDM.


Eligibility Criteria:
Inclusion criteria:

1. Age ≥ 18 years.
2. Fulfillment of the ACR/EULAR 2010 classification criteria for RA \[9\].
3. Moderate or high disease activity, according to CDAI ≥ 10, at the baseline visit.
4. Intent to modify DMARD therapy (i.e., adding a DMARD, switching to a new DMARD, or changing DMARD dosage) by the patient and HCP.

Exclusion criteria:

1. Current or previous use of ArthritisPower™ by the patient.
2. Lack of access to an ArthritisPower™ compatible device (e.g., smartphone, tablet, or computer)
3. Inability or unwillingness to participate with using the ArthritisPower™ app for this study
A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer

This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who have completed a prior study with IV Herceptin.


Eligibility Criteria:
Inclusion Criteria:

* Ongoing participants from any completed global Roche-sponsored Herceptin trial
* Participants enrolled in any Roche-sponsored Herceptin trial who have at least stable disease (or whose disease has not recurred) during Herceptin therapy at the end of the lead-in trial
* Available study termination data (including tumor assessment and laboratory data) on the Case Report Form for the lead-in trial
* Judged eligible by the investigator following a thorough risk/benefit assessment, if signs of chronic heart failure developed during the lead-in trial

Exclusion Criteria:

* Pregnant or nursing women
* Women of childbearing potential unless using effective contraception as determined by the investigator
* Severe dyspnea at rest requiring supplementary oxygen therapy
* Severe uncontrolled systemic disease
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Protease-Inhibitors ("PI") Failures

The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie adults with chronic hepatitis C virus ("HCV"), who have not responded to prior treatment with protease inhibitors.

The "Triple therapy" of AbbVie attacks various sites of the viral genome, thus increasing the potential efficacy of the treatment, especially for patients who have failed PI treatment.

Patients with genotype 1 HCV, who underwent past triple therapy (Telaprevir, Boceprevir or Simeprevir with Pegylated interferon / Ribavirin) and are non-responders, partial responders or in relapse - will be screened in all research centers up to 30 days before the first treatment.

At the end of the initial assessment - the recruited participants will be allocated to different treatment groups in accordance with the hepatitis virus subtype 1a, 1b and presence of cirrhosis, as follows:

* Group A - genotype 1b without cirrhosis - 12 weeks of treatment \*
* Group B - genotype 1b with cirrhosis - 12 weeks of treatment
* Group C - genotype 1a without cirrhosis - 12 weeks of treatment
* Group D - genotype 1a with cirrhosis - 24 weeks of treatment

(\* Only this group will not get Ribavirin)

During the treatment period, participants will be asked to describe the treatment's tolerability (in terms of side effects) using self-administered questionnaires: SF-36, and WPAI Hep C v2.0.

The follow up will also include physical assessments, side effects documentation, blood tests, abdominal Ultrasound and Fibroscan.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hepatitis C, genotype 1A or 1B.
* Documentation of PI failure of treatment at least 12 months prior to study entry.
* Patients with cirrhosis - (only patients with cirrhosis Child A with only 5 points).

Exclusion Criteria:

* Inability to stay in the study for 36 weeks.
* Diagnosis of cross-contamination by HIV or Hepatitis B virus.
* Renal disfunction (creatinine clearance \<30 ml / min).
* Evidence of hepatic carcinoma.
* Another serious disease, which may interfere with the study.
* Pregnant / breast-feeding women.
* Men with pregnant partners.
* Drug or alcohol abuse in the six months preceding the study.
* Chronic liver disease other than hepatitis C (such as Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis).
* Current other treatment for HCV.
* Past PI Failure due to adverse events.
* Patients with cirrhosis Child B.
* Patients with cirrhosis, who were at child B and improved to child A after treatment.
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)

The purpose of this study is to compare the safety and effectiveness of three doses of intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration following initiation of anti-VEGF therapy with three doses of Lucentis®.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be age 50 years or older
* Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration.
* The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent).
* Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.

Exclusion Criteria:

* Prior pharmacologic treatment for AMD in the study (patients can not have previously received Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroid treatments, PDT, radiation treatment, or any experimental therapies for AMD in the study eye)
* Any intraocular surgery of the study eye within 12 weeks of screening
* Previous posterior vitrectomy of the study eye
* Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.
Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy

The purpose of this study is to evaluate the incidence of complications with the isolated Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of complications with isolated Roux-en-Y reconstruction with those of Billroth-II-type reconstruction after pancreaticoduodenectomy.

The purpose of this study is to clarify whether isolated Roux-en-Y reconstruction declines the incidence of postoperative complications after pancreaticoduodenectomy compared with Billroth-II-type reconstruction. Especially, it is important to decline the incidence of pancreatic fistula, because pancreatic fistula affects a postoperative course. However, there is no report that demonstrated postoperative complications of isolated Roux-en-Y compared with those of Billroth-II-type reconstruction. We conducted a prospective randomized trial on patients who underwent pancreaticoduodenectomy.

Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Wakayama Medical University Hospital.

The primary endpoint was defined as the incidence of pancreatic fistula. The secondary endpoints were the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital (WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent.

Eligibility Criteria:
Inclusion Criteria:

* the patients had undergone pancreatic head resection at Wakayama Medical University the patients obtained appropriate informed consent

Exclusion Criteria:

* young patients (less than 20-years-old)
* patients with severe complications which were possible to prolong hospital stay
* patients undergone hemodialysis
* patients combined resection of other organs
* patients who were diagnosed inadequacy for this study by a physician
* patients without an informed consent
Protein Source, Nutrition Messaging, and Food Intake

The objective of this study is to determine how the protein source and the physical form of food consumed at breakfast impact food intake. Research will be conducted by assessing feelings of hunger, food preference and blood glucose in healthy adults following the ingestion protein-based (animal versus plant) drinks similar calorie and protein content.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, no known health conditions

Exclusion Criteria:

* Taking medication, excluding hormonal birth control
* Food allergies
* Food intolerances
Magnesium Treating Subarachnoid Hemorrhage Vasospasm

A randomized clinical trial investigating magnesium sulphate ability to reduce risk of cerebral vasospasm after acute subarachnoid hemorrhage hence improving outcome particularly in haptoglobin 2-2 patients who are highly susceptible for severe complications after subarachnoid hemorrhage.

Study Design and Location:

Investigators propose a double blinded, randomized (1:1), placebo-controlled, multicenter, clinical trial including patients with acute aSAH. Participants will be allocated either to MgSO4 or placebo. The permission to conduct the study protocol will be considered for approval by the ethics committee of General Committee of Teaching Hospitals and Institutes (GCTHI), Egypt. The study will be conducted in 3 centers; El-Materia Educational Hospital, Ain Shams University Hospitals and Nasr City Insurance Hospital. The assigned centers for this study represent large-volume referral stroke centers that provide comprehensive management protocols for aSAH.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders
* age over 18 years old
* diagnosis of acute aSAH (≤ 48 hours) confirmed with angiographic evidence of cerebral aneurysm and CT brain on admission.

Exclusion Criteria:

* subarachnoid hemorrhage due to non-aneurysmal causes
* cerebral stroke of any type during past month
* decompensated heart failure, renal failure or hepatic failure
* difficult bilateral transtemporal transcranial Doppler (TCD) insonation of intracranial arteries due to thick temporal bone of the skull.
Cardiovascular Effects of Carbetocin Given During Elective Cesarean

The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.

Patients undergoing elective cesarean under spinal are included in the study. These patients are treated with carbetocin to reduce blood loss from the lining of the womb after delivery of the baby. The study is a randomised double blind controlled trial with 2 groups. One group will receive carbetocin quickly, the second group will receive carbetocin slowly. The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.

Eligibility Criteria:
Inclusion Criteria:

* elective cesarean delivery under spinal,
* low risk for post partum hemorrhage,
* able to understand english

Exclusion Criteria:

* cesarean under general anesthesia,
* bleeding condition,
* placenta previa,
* unable to understand english
A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients

This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients with advanced or metastatic solid tumors.

Phase 1b Study:

Indication of phase 1b study is the advanced or metastatic solid tumors (including, but not limited to, colorectal cancer, gastric cancer, and ovarian cancer).

Phase 2 Study:

Indication of phase 2 study is unresectable advanced, metastatic or recurrent biliary tract cancer (BTC) (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma).

Eligibility Criteria:
Key Inclusion Criteria:

* P1b only: Patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
* P2 only: Patients with histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, ampullary carcinoma)
* P2 only: Patients who have shown disease progress or recurrence of disease after receiving first-line or second-line systemic chemotherapy, including treatment with gemcitabine in combination with a platinum agent
* Patients aged 19 years or older
* At least one lesion measurable defined by response evaluation criteria in solid tumors (RECIST) version 1.1.
* Life expectancy ≥ 12 weeks
* ECOG performance status 0 or 1
* Women of childbearing potential must have a negative pregnancy test outcome
* Patients must provide written informed consent to voluntary participation in this study

Key Exclusion Criteria:

* History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody) and irinotecan or paclitaxel
* Less than 4 weeks have elapsed since a surgery
* History of cardiac illness: New York Heart Association (NYHA) class ≥ II congestive heart failure (CHF), uncontrolled hypertension, hypertension crisis, pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina
* Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the previous anticancer therapy
* Severe infections or major and unhealed injury (active ulcer, untreated fracture)
* Symptomatic or uncontrolled central nervous system (CNS) metastasis
* Pregnant or lactating women or patients planning to become pregnant during the study
* Participation in another clinical trial within 30 days prior to initiation of study treatment and received an investigational drug treatment
* Administration of antiplatelets or anticoagulants within 2 weeks prior to screening
* Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
* HIV or other severe diseases that warrant the exclusion from this study
Impact of a Dedicated Geriatric Sector on the Loss of Functional Autonomy at 1 Month for Patients Admitted to Emergencies and Non-hospitalised

Several studies have shown that going to the emergency room is a risk factor for loss of independence in the elderly. It has been shown that the period following an emergency room visit without hospitalization is a period of vulnerability for the elderly.

The functional decline, or loss of functional autonomy, of the elderly is associated with an increase in institutionalization, mortality and costs to society.

Studies have highlighted the risk factors for functional decline in the elderly, such as pre-existing functional and cognitive decline, undernutrition, but no model of care has yet prevented the risk of loss of autonomy after a stay in the emergency room.

A full and early geriatric assessment could prevent functional decline after the emergency room visit.

The primary objective of the study is to assess the impact of a dedicated geriatric sector on the functional decline at 1 month of patients admitted to emergencies without hospitalization by comparing an intervention group (patient having benefited from the geriatric sector) and a group witness ("classic" emergency patient).

The secondary objective is to evaluate the impact of this sector on the number of falls at home as well as the readmission rate within 1 month of going to the emergency room.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 75 years
* Emergency room consultation between 7:30 a.m. and 5:30 p.m.
* Relevant to the adult emergency department
* Return home after consultation

Exclusion Criteria:

* Age less than 75 years
* Arrival time between 5.30 p.m. and 7.30 a.m.
* Need to take care of unhooking
* Belonging to the short sector, versatile sector
* Patients hospitalized after consultation
Efficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension

The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension

Patients with primary and secondary pulmonary hypertension will be recruited and admitted to the ICUs of the National Taiwan University Hospital. Each patient will undergo Swan-Ganz catheterization and hemodynamic monitoring during administration of sildenafil. Efficacy of inhaled NO and Iloprost will also be compared.

Eligibility Criteria:
Inclusion Criteria:Patients with primary and secondary pulmonary arterial hypertension

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Exclusion Criteria:Unstable patients or patients with allergy to sildenafil