cyrilzakka/clinical-trials huggingface dataset:
Testing myWHI: Online Self-help Programs for Headaches

This randomized controlled trial will compare the effectiveness of two online self-guided programs for youth and young adults with migraine against usual care.


Eligibility Criteria:
Inclusion criteria:

* aged 14-40 years
* fluent in the English language (i.e., speaking, reading and writing);
* for 14-17 year olds: suffer from headaches for a minimum of three months
* for 18-40 year olds: suffer from headaches for a minimum of one year
* suffer from migraine headaches as indicated with a score of 2 and above on the ID Migraine
* have a Smartphone as PRISM has been designed to be accessed from a Smartphone and SPHERE encompasses the myWHI diary which has also been designed to be used from a Smartphone
* use the Smartphone for activities other than texting and calling (e.g., email, Facebook) as the programs are designed for migraineurs who are familiar with using Smartphones and use them in their daily life
* have daily Internet access from their Smartphone, because running the programs require an Internet connection
* minimum of four headache days during 4 weeks that they are asked to use an electronic headache diary

Exclusion criteria:

* health care professional has not ruled out any underlying medical condition related to their headaches (e.g., head trauma, meningitis)
* are pregnant, planning to get pregnant (in the next 4 to 6 months), or breastfeeding, as hormonal changes are known to exert potent influences on migraine headaches
* have an impairment which compromises their ability to give informed consent
* having been diagnosed with psychosis and/or schizophrenia, because a past or current diagnosis may likely interfere with the participants ability to fully participate in the study
* have participated in our recent three-armed pilot RCT (i.e., any participant who consented and was randomized)
* they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy when they asked to use it for 4 weeks
* More than 15 headache days during the 4 weeks that they are asked to use an electronic headache diary
Testing the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion

the purpose of this study is to examine the success rates of Karman curettage in completing the abortion after failed recurred treatment with Misoprostol for women with missed abortion.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women diagnosed with missed abortion treated in Meir Medical Center.
* The abortion occured during the first trimester of pregnancy.
* Patients who chose drug therapy (Misoprostol), after retained products of conception were evident on ultrasound.

Exclusion Criteria:

* patients with mullarian abnormality (i.e. septal uterus, myoma etc.)
* patients with significant bleeding
* Endometrial wall (residua) greater than 20 mm.
* known or suspected infection
* known clotting defect
* women after cesarean section
* closed cervix
Effectiveness of Remote Self-care Education for Ostomy Patients

The primary aim of this study is to evaluate whether remote education is as effective as in-person education in improving self-care behaviors of ostomy patients.

After signing the informed consent form, patients with ostomy will be assigned to the intervention or active control group (1:1). The intervention group will receive a total of four remote educational sessions over 2 months. The control group will receive the standard care, consisting of in-person standard education.

Eligibility Criteria:
Inclusion Criteria:

1. having undergone a surgical operation with subsequent ostomy placement;
2. being at least 18 years old of age;
3. absence of cognitive decline,
4. absence of any
5. being able to manage the software on the smartphone
6. be willing to participate to the trial and sign the informed consent form.

Exclusion Criteria:

1. presence of a cognitive decline, assessed with a score \> 4 at the Six-item Screener
2. presence of any stomal or peristomal complication
3. not being able to read and speak Italian language
Hepatic Vein-sparing Hepatectomy for Colorectal Liver Metastases at the Caval Confluence

Major hepatectomies are generally selected for tumors involving the hepatic vein (HV) at the caval confluence (CC). As alternative, HV reconstruction has been proposed. The present study aimed to evaluate the feasibility and safety of a HV-sparing policy guided by intraoperative ultrasonography (IOUS) in a cohort of patients having at least one colorectal liver metastasis (CLM) in contact with a HV at CC. HV section can be avoided in the large majority of cases thanking to CLMs detachment or to HV partial resection or reconstruction: this policy seems feasible, safe, reduces the need of major hepatectomies, and oncologically provides an adequate local control.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of at least one CLM in contact with HV at caval confluence and HV patency at preoperative imaging
* at least 6 months of follow-up after surgery

Exclusion Criteria:

* suspected or ascertained thrombosis or full tumoral involvement of HV at preoperative imaging
* portal pedicle infiltration and/or thrombosis
* unresectability at laparotomy for any extra-hepatic or intrahepatic reason not related to tumor-vessel relations
Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck

maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine


Eligibility Criteria:
Inclusion Criteria:

1. male and female patients aged 18 years or older
2. patients with histologically confirmed squamous cell carcinoma of the head and neck
3. patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
4. measurable tumour deposits by one or more radiological techniques (MRI, CT)
5. life expectancy of at least 6 months
6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
7. patients must have given written informed consent (which must be consistent with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)

Exclusion Criteria:

1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
2. known secondary malignancy requiring therapy
3. active infectious disease
4. brain metastases
5. neuropathy grade 2 or above (excluding pre-existing neuropathy of cranial nerves due to surgery, radiotherapy or tumour growth)
6. absolute neutrophil count less than 1,500/mm3
7. platelet count less than 100,000/mm3
8. bilirubin greater than 1.5 mg/dl (\> 26 μmol/L, système internationale (SI) unit equivalent)
9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
10. serum creatinine greater than 1.5 mg/dl (\> 132 μmol/L, SI unit equivalent)
11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
12. chemo- or immunotherapy within the past three weeks prior to treatment with the trial drug or during the trial
13. radiotherapy to head and neck region within the past four weeks before inclusion or during the trial
14. men and women who are sexually active and unwilling to use a medically acceptable method of contraception
15. pregnancy or lactation
16. treatment with other investigational drugs or participation in another clinical trial within the past three weeks before start of therapy or concomitantly with this trial
17. patients unable to comply with the protocol
STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients

Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks

This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Stage 3-5 CKD not on dialysis
* Patients ≥ 70 years of age
* Haemoglobin \< 110g/L at screening
* Transferrin saturation ≥ 15% at screening

Exclusion Criteria:

* Clinical history of type 2 diabetes mellitus
* Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant
* Uncontrolled hypertension on two separate measurements during screening
* Use of any erythropoietic protein within 12 weeks of screening
Mobile Apps for the Treatment of Depression

Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for increasing the adherence of individuals to psychotherapy treatments which may subsequently increase symptom reduction and improve clinical outcomes. Apps offer the opportunity for real-time tracking of behavior and have the ability to provide prompt feedback and reminders in a convenient, readily available technology. The immediacy and convenience of apps may be responsible for the observed improvements in adherence on the part of the patients relative to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy. These features are relevant to behavioral activation (BA) protocols, the effects of which are often attenuated by failure to adhere to regular practice and tracking of behavior. The Mood Coach app is a BA protocol developed to provide a convenient means of planning and tracking activity, and monitoring mood responses to scheduled increases in activity. This project evaluates the utility of this app as an adjunct to standard BA treatment. The investigators predict that participants assigned to the BA+app condition will demonstrate greater adherence to the BA treatment compared to the standard BA condition. The investigators also predict that the participants in the BA+app condition will report greater satisfaction with the app compared to the standard BA protocol that utilizes paper and pencil materials.


Eligibility Criteria:
Inclusion Criteria:

* Veterans aged 18 and older
* Speak and understand English
* Meet criteria for major depressive disorder
* Willing to participate in psychotherapy for depression

Exclusion Criteria:

* Current psychotic disorder diagnosis
* Current bipolar disorder
* Diagnosed with a substance use disorder that is not currently being addressed by a non-study provider
* Patients receiving a concurrent evidence-based psychotherapy for depression or PTSD
Emergency/Compassionate Use - Muscular VSD Occluder

Expanded access to the AMPLATZER Muscular VSD Occluder


Eligibility Criteria:
Inclusion Criteria:

* Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER Muscular VSD clinical trial
A Study to Evaluate the Effectiveness and Safety of Multiple Applications of Imiquimod 5% Cream for the Treatment of Actinic Keratoses in Organ Transplant Recipients

The purpose of the study is to compare effectiveness and safety of multiple applications of imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.


Eligibility Criteria:
Inclusion Criteria:

* Have a total of 4-10 actinic keratosis (AK) lesions located on either face or scalp
* If female and of childbearing potential, have a negative urine pregnancy test at treatment initiation, and willing to use a medically acceptable method of contraception during the treatment period
* Renal, liver or heart transplant recipients

Exclusion Criteria:

* Graft rejection with loss of the graft in the medical history
* Unstable status of organ transplant disease during the last 12 months
* Known to be pregnant or lactating
Psychotherapy and Cardiovascular Risk Factors in Depression

Prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. Depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure alterations. These hemodynamic alterations may explain in part the increased cardiovascular risk associated with depression.

The purpose of this study is to determine whether treatment for depression with cognitive behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors. Hemodynamic assessments including heart rate, heart rate variability, continues blood pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular resistance will be conducted at baseline, after treatment and 2-month follow up. In addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood pressure dipping and immunological biomarkers will be assessed. Eighty patients with Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long, weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic parameters without any intervention and the impact of repeated-measurement.


Eligibility Criteria:
Inclusion Criteria:

* patients with Major Depression (DSM IV), BDI \>=14
* age:18-65 years
* patients without antidepressive medication (stable for at least 2 weeks)
* comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating

Exclusion Criteria:

* current psychotherapy
* psychotic disorder
* serious drug-addiction
* drugs which seriously affect immune status (except contraceptives) or central
* nervous system functions (except antidepressants)
* infections during the last 2 weeks
* injuries during the last 2 weeks
* neurological disorders
* diseases which affect immune status or central nervous system functions (e.g. rheumatoid arthritis, CVD,etc.)
GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results

Evaluate the safety and tolerability of GH35 in patients with KRAS mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects greater than or equal to 18 years old.
2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
3. Expected survival time ≥12 weeks.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
6. Have documented disease progression or intolerance after first-line treatment.

Exclusion Criteria:

1. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
2. Previous accept with KRAS G12C inhibitor.
3. Uncontrollable general infection.
4. Serious cardiovascular disease.
5. Left ventricular ejection fraction (LVEF) \<50 %.
6. Known history of hypersensitivity to any of the excipients of GH35 tablets
7. Pregnant or nursing (lactating) women.
Dynamic Changes in Circulating Tumour Cells Protein Expression

This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4).

The investigators enroll patients with histologically confirmed advanced stage (T3 or T4, N1/2, M0/1) colorectal adenocarcinoma with molecular analysis on RAS mutant status. The participants are enrolled within 3 weeks at the time of progression disease (PD) from any line of therapy. Blood samples were collected from each participant after obtaining informed consent. Permission to perform CTCs analysis from blood was obtained from the Regional Ethical Committee (No.2013/34) and the study is conducted in accordance with the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2 (scores range from 0 to 5, with higher numbers reflecting greater disability) ,
* medically able to receive chemotherapy.

Exclusion Criteria:

* evidence of infective disease before enrollment ,
* a history of another primary cancer within the previous 3 years,
* the presence of synchronous primary colorectal cancer.
Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.

This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.

Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S. Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and is clinically promising. It is expected that the addition of Cytoxan in patients with previously untreated CLL and patients who have relapsed or failed prior therapy may benefit from combined therapy using Nipent, Cytoxan and Rituxan. It is unknown how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent regimen, however, patients will be monitored for toxicities. It is expected that bone marrow toxicities will not increase to unreasonable levels.

The primary objective of the study is to determine the overall efficacy response rate following treatment with Nipent, Cytoxan and Rituxan of patients with previously untreated or treated CLL. The secondary objectives of the study are to determine the duration of response, time to progression, time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Stage II, III or IV Chronic Lymphocytic Leukemia
* Disease requires chemotherapeutic treatment
* CT or MRI scan confirming measurable tumor size
* Documentation of CD markers
* Up to one prior treatment regimen
* Expected survival greater than 6 months
* ECOG performance status of 0-2
* Adequate renal, bone marrow and liver functions
* Negative pregnancy test (females of childbearing potential)
* Must agree to use acceptable birth control, if fertile
* Must complete Informed Consent
* No heart disease and must have adequate cardiac function
* Must test negative for viral Hepatitis B and C

Exclusion Criteria:

* More than one prior treatment for Chronic Lymphocytic Leukemia
* Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs
* Known HIV or AIDS illness
* Thyroid disease requiring medication
* History of any malignancy that could affect the diagnosis or assessment of the study treatment
* Pregnancy or breast feeding
* Evidence of Hepatitis B or C infection
* Inability to comply with the requirements of the study
Post Intravitreal Injection Topical NSAID vs. Patching

A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.

This is a single masked, randomized, placebo-controlled study that will enroll approximately 60 subjects with recent active retina related disease requiring intravitreal agents. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive nepafenac 0.3% suspension or a sham procedure. Subjects will have a one in three (33%) chance of receiving active treatment (no sham procedure), a one in three (33%) chance of receiving patching procedure (no active treatment) or a one in three (33%) chance of receiving placebo (no active treatment).

Study participants will then complete the Visual Analog Scale immediately following injection and then after 1 hour, and, 24 hours. The VAS data along with relevant data related to each subject's injection will also be compiled, including, but not limited to: drug injected, diagnosis, co-morbid conditions, history of previous injections, visual acuity, age, and gender.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Already scheduled for anti-VEGF injection based on standard of care for disease process.
* Ability to provide written informed consent
* Capable of complying with study protocol.
* Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care

Exclusion Criteria:

* History of past intraocular injection of steroid medication.
* Experiencing baseline eye pain
* Monocular; non-study eye with VA\<20/100.
* Unwilling or unable to follow or comply with all study related procedures
Congenital Aniridia Patient Questionnaire

Congenital aniridia is a pan-ocular genetic disease characterized by a partial or complete absence of the iris, hence its name. The prevalence ranges from 1 / 40,000 to 1 / 96,000 births, but it may be underestimated. This condition combines several types of eye damage and could associate systemic manifestations, with a variable phenotype and genotype.

This study aims to identify eye and systemic manifestations in congenital aniridia and to determine the patients' knowledge of their own disease through a survey prepared by ophthalmologists from the Ophthalmology Department of Necker-Enfants Malades Hospital, reference center in France for this pathology. The patient fills it out only once.

Congenital aniridia is a pan-ocular genetic characterized by partial or complete absence of the iris, hence its name. The prevalence ranges from 1 / 40,000 to 1 / 96,000 births, but it may be underestimated. This condition combines several types of eye damage :

* Partial or complete absence of iris, iris abnormalities
* Glaucoma
* Cataract
* Corneal opacifications with neovascularization
* Foveal hypoplasia with nystagmus
* Hypoplasia of the optic nerve The signs of the disease vary from one individual to another, even within the same family. Iris abnormalities and foveolar hypoplasia are the most constant signs. Affected patients have a highly compromised visual prognosis in adulthood, and are very often considered visually impaired with criteria for legal blindness.

Congenital aniridia can also be associated with several severe systemic manifestations, including syndromic aniridia (WAGR syndrome and Gillespie syndrome).

The major gene responsible for autosomal dominant forms of congenital aniridia is PAIRED BOX GENE 6 (PAX6) (MIM#607108) with over 500 pathogenic variants reported to date.

Congenital aniridia is therefore a rare, pan-ocular disease associating systemic manifestations, with a variable phenotype and genotype.

This study aims to identify eye and systemic manifestations in congenital aniridia and to determine the patients' knowledge of their own disease through a survey prepared by ophthalmologists from the Ophthalmology Department of Necker-Enfants Malades Hospital, reference center in France for this pathology. The patient fills it out only once.

Eligibility Criteria:
Inclusion Criteria:

* Any patient ≥ 18 years old with congenital aniridia and able to respond independently to the study survey,
* or patients under 18 years old with congenital aniridia, whose parents can answer the study survey,
* adult patients or holders of parental authority and minor patients informed and not opposed to participation in the study.

Exclusion Criteria:

- Patients with neurological disorders preventing them from answering the survey, except in the case of minor patients, if the parents can answer for the patient.