cyrilzakka/clinical-trials huggingface dataset:
High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents

High sensitivity to targeted agents has been observed in patients whose tumor cells present a genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR mutations) together with addiction to the given target. More recently, activation of "alternative pathways" (Kras mutation, PI3K mutations) have been reported as a common resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab).

From these data has emerged the hypothesis that identification of the deregulated pathway through new molecular tools could allow to propose a more tailored targeted regimen.

Based on these concepts, numbers of phase I/II trials enrich their populations in patients presenting specific molecular alterations.

High throughput technologies (array CGH, sequencing, gene expression array) identify deregulated genes. In addition, these technologies determine whether such genomic alterations are single (expected efficacy of single agent) or multiple (rationale for combination). In a pilot study that included 135 patients, we recently performed a combination of array CGH and hot spot mutation array in order to drive patients into phase I/II clinical trials. This study led to the conclusions that high throughput technologies i. are feasible (80%) and robust, ii. identify "targetable" genomic alterations in around 40% of samples.

In the present study, the investigators will perform high throughput technologies to drive 400 metastatic breast cancer patients into specific phase I/II trials.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women with histologically diagnosed breast cancer
* Metastatic relapse or stage IV breast cancer at diagnosis
* Metastases amenable to biopsy
* Age \<70 years old
* PS 0/1
* No restriction regarding the number of previous chemotherapy or endocrine therapies

Exclusion Criteria:

* Age \<18
* Life expectancy \<3 months
* Symptomatic or progressing brain metastases
* Progressive patients at the time of biopsy
* LVEF \<50% (MUGA or ultrasonography)
* Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
* Absolute neutrophil count \< 1.5 x 109/L
* Platelet count \< 100 x 109/L
* Haemoglobin \< 90 g/L
* ASAT/ALAT \> 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or \> 5 times ULN in the presence of liver metastases
* Total bilirubin \> 1.5 times ULN
* Creatinine \>1.5 times ULN
* Corrected calcium \> ULN
* Phosphate \> ULN
* Abnormal blood coagulation that contra-indicates biopsy
* Patients deprived of liberty or placed under the authority of a tutor
Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

letrozole administration with misoprostol raises the rate of complete abortion

Hypothesis:

In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age less than 64 days gestation (\<9 wks).
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 25 kg/m2.
* Missed abortion.

Exclusion Criteria:

* Molar pregnancy.
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.
Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer

RATIONALE: Use of a web-based risk assessment tool may help improve screening rates for colorectal cancer.

PURPOSE: This randomized clinical trial is studying personal electronic health records to see how well they work in improving screening rates for colorectal cancer.

OBJECTIVES:

* To assess whether screening rates for colorectal cancer (CRC) can be substantially increased among adults in primary care through the use of a personal electronic health record that provides a link to a validated web-based tool to estimate an individual's risk of CRC and electronic scheduling of CRC screening exams.

OUTLINE: This is a multicenter study. Participants are stratified according to participating Harvard Vanguard Medical Associates (HVMA) center. Participants are randomized to 1 of 2 arms.

* Intervention arm: Participants receive an electronic message within their MyHealth account on behalf of their primary care physician providing a link to a web-based tool to allow them to assess their personal risk of colorectal cancer (CRC). The tool provides an estimate of an individual's personal risk of developing different types of cancer over the next 10 years relative to others of the same age and sex. The tool also recommends steps that individuals can take to reduce their risk. The tool includes questions about family history; prior screening tests; dietary habits (red meat, fruits, and vegetables); weight and height; and use of folate, aspirin, estrogen therapy, alcohol, and tobacco. In addition, the electronic message provides information regarding options for CRC screening, emphasizing colonoscopy every 10 years per the current HVMA guidelines, followed by the secondary recommendation of annual fecal occult blood testing. Detailed information is provided in the form of a link to online educational materials. Participants may request either colonoscopy or fecal occult blood testing by responding to the electronic message and indicating their preference. Participants who request colonoscopy are contacted by the gastroenterology department to proceed with CRC screening; participants who request fecal occult blood testing will receive a stool card test kit in the mail from their primary care physician.
* Control arm: Participants receive no intervention.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Overdue for colorectal cancer screening (identified using automated extracts from the electronic medical record), as defined by the following criteria:

  * No fecal occult blood test within the past 12 months
  * No flexible sigmoidoscopy within the past 5 years
  * No colonoscopy within the past 10 years
* Receiving primary care at a Harvard Vanguard Medical Associates (HVMA) center
* Registered to use the HVMA patient portal (MyHealth) AND has an active MyHealth account

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Implementing an Intervention to Foster Resident and Family Engagement in Care Planning

This study is a pilot test of an intervention to engage residents and their family and the healthcare team in a collaborative approach to decisions about care planning in long-term care. The intervention includes leadership coaching with the management team, an educational bundle that includes a one-day education session for staff and managers on communication strategies and ways to engage family and residents in care planning and follow-up visits, and a series of resident and family led huddles (brief, 15 minute meetings) to discuss a care related topic with staff to foster proactive communication and information sharing for care planning.

This study is a pilot test of an intervention to engage residents and their family and the healthcare team in a collaborative approach to decisions about care planning in long-term care. The intervention includes leadership coaching with the management team, an educational bundle that includes a one-day education session for staff and managers on communication strategies and ways to engage family and residents in care planning and follow-up visits, and a series of resident and family led huddles (brief, 15 minute meetings) to discuss a care related topic with staff to foster proactive communication and information sharing and care planning.

The study aims are to describe the feasibility and acceptability of the resident and family engagement intervention, and to evaluate the following outcomes: resident quality of life, resident and family satisfaction with care, and staff quality of work life. The investigators aim to recruit 20 staff, the leadership team, and 12 resident-family dyads from four long-term care facilities who will receive the intervention and complete the survey measures. The expected outcome from this study is an increased understanding of how to engage residents and family in care decisions impacting quality of life.

Amendment: Due to the COVID-19 pandemic, the anticipated sample size is smaller and as a result, our outcomes will be explored qualitatively through interviews.

Eligibility Criteria:
Inclusion Criteria for Residents:

* residents who can communicate in English
* residents (aged 65 or older) who have a visiting family member who is their substitute decision maker- both the resident and their family member will participate in the huddles

Exclusion Criteria:

* residents with severe cognitive impairment
* residents who do not speak English
Ultrasound Guided Axillary Venous Cannulation in Pediatrics

The purpose of this prospective randomized study was to compare landmark-subclavian venous access to ultrasound-guided axillary venous access when performed by pediatric anesthesiologists.

Objective: Subclavian vein catheterization may cause various complications. The investigators will compare the real-time ultrasound-guided axillary venous access vs. the landmark method- subclavian venous access in pediatric paticipants. (the needle insertion point of ultrasound-guided axillary venous is axillary vein. and the needle insertion point of landmark method is infraclavicular subclavian vein)

Design: Prospective randomized study.

Setting: Operating room of a tertiary medical center.

Interventions: The investigators will compare the ultrasound-guided axillary vein cannulation (66 paticipants) vs. the landmark method (66 pa- ticipants).

Eligibility Criteria:
Inclusion Criteria:

* surgery under general anesthesia require central venous catheterization

Exclusion Criteria:

* hematoma in central vein central vein anomaly catheterization site infection
Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

This study aims to investigate the safety of serum product containing low dose of alpha hydroxy acid (AHA) i.e. 1% Glycolic acid and Lactic acid and Polyglutamate acid derivatives (PGA) for post-inflammatory hyperpigmentation skin in Malaysia. The study duration is 8 weeks and the skin assessment will be carried out at baseline, week 4 and week 8.The main questions this study aims to answer are:

1. To investigate the safety of serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA for post-inflammatory hyperpigmentation skin among Malaysian.
2. To assess the patient satisfaction after using serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA among Malaysian.


Eligibility Criteria:
Inclusion Criteria:

* Malaysian from 18 to 40 years old.
* Participants with post-inflammatory hyperpigmentation (PIH).

Exclusion Criteria:

* Participant with known systemic or skin disease and any underlying medical illness
* Pregnant, breastfeeding women or planned pregnancy during the study period.
* Had reported history of dermatologic conditions (i.e. Atopic dermatitis, psoriasis) or known allergies to any ingredients that may be found in the product.
* Had any cosmetic procedures such as Botox, laser and light treatment, facial surgery, chemical peel and any procedures that may improve skin texture 1 month before the study.
* Had history of taking isotretinoin for the past 6 or 12 month and AHA (alpha hydroxyl acids) containing products or any other products for treating hyperpigmentation skin or melasma 1 month prior to study.
A Comparative Study on Trans-umbilical Single-port Laparoscopic Extra-peritoneal Approach Versus Conventional Repair for Inguinal Hernia in Children

Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly performed hernia repair in children. The conventional approach this is done with2small trocars to 1trocar . however the wound complications of infection and pain and the recurrent rate have not been resolved. The aim of the study was to described a new way of extra-peritoneal high ligation of hernia sac. This method combines the single-port laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia repair in children. The investigators hoped that this study will prove that the extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as the conventional technique in the cure of inguinal hernia and may results in lower recurrence and reduce incidence of wound complications.


Eligibility Criteria:
Inclusion Criteria:

unilateral inguinal herina age between 6 months and 13 years no history of abdominal or inguinal operations of male patients ,only those with completely descended testes were included

Exclusion Criteria:

the bilateral heina the recurrence herina
Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?

This study will be conducted to evaluate the protective effects and mechanisms of antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.

The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine. The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI.

Eligibility Criteria:
Inclusion Criteria:

1. Well functioning kidney (serum creatinine \<1.2 mg/dl).
2. Solitary renal stone.
3. Size: 25 mm or less in the largest diameter.

Exclusion Criteria:

1. Contraindications to ESWL
2. Previous surgical treatment of renal stones.
3. Congenital renal anomalies.
4. Pediatric patients (age \<18 years).
5. Patients with Diabetes or hypertension
Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR
* aged 8-80 years old
* with no more than 3 lesions
* ulcerative and non-ulcerative ulcers less than 4 cm diameter.
* allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia)
* capable of signing an informed consent or having capable guardians (in the case of minors).
* Children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians.

Exclusion Criteria:

* lesions less than 2cm from the nose, mouth, ears, or eyes.
* clinically diagnosed with mucosal involvement.
* evidence of lymph node involvement on exam.
* unable or unwilling to commit to the treatment and follow-up plan.
* prior CL treatment within last 1 month.
* pregnant or lactating
* uncontrolled severe systemic illness or immunocompromised state.
Search a Correlation Between Lp(a) Rate and TFPI Activity in Obese Patients With Chest Pain Like Angina

Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is influenced by cardiovascular risk factors which obesity (Body Mass Index\>30). Obesity is associated with an increase risk of cardiovascular complications.

Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is a risk factor for recurrent coronary events in obese patient.

Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .

The aim of this study is to research reverse association between Lp(a) and TFPI activity in obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and effect of aspirin.


Eligibility Criteria:
Inclusion Criteria:

* Major
* Men
* Obese BMI\>30
* No aspirin treatment before inclusion
* Coronary exploration: coronary angiography or tomography coronary angiography
* Chest pain like stable angina

Exclusion Criteria:

* Women
* Severe hepatic insufficiency
* Inflammatory disease
* Neoplasia
* Protein S deficiency
* Aspirin treatment 10 days before inclusion
* Oral anticoagulant treatment at inclusion
* Heparin or low molecular weight heparin treatment at inclusion
Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children

This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.

At public sector clinics in Lusaka, Zambia, approximately 4,000 HIV-exposed infants between 4 and 12 weeks of life will be randomized in this trial of point-of-care virologic testing to improve outcomes of HIV-infected children in Zambia. There is a standard of care (SOC) or control arm and an intervention arm known as the Alere arm. In both study arms, early infant diagnosis (EID) will be provided at 6 weeks of life. Infants randomized to the SOC arm will receive EID through the existing prevention of mother-to-child-transmission (PMTCT) program, with samples sent to an off-site laboratory for DNA PCR testing. Infants randomized to the intervention arm will receive POC diagnostic Alere Q qualitative test (along with a dried blood spot (DBS) drawn for confirmatory DNA PCR).

HIV-infected infants will be followed for 12 months. The acceptability of point-of-care testing for EID will also be determined through the use of cross-sectional surveys of clinicians, laboratory personnel, and parents/guardians.

The feasibility will be assessed by a time-in-motion (TIM) and value stream mapping (VSM) analyses will also be conducted to compare the Alere Q to two additional testing technologies.

Eligibility Criteria:
Inclusion Criteria:

* 4 to 12 weeks of life
* documented HIV exposure through seropositive maternal or infant HIV antibody test
* with a parent or guardian will and able to provide written informed consent and to have the participant followed for 12 months after study enrolment

Exclusion Criteria:

* Infants will be excluded from participation if they have major congenital anomalies or other medical conditions that would require management at a referral facility or otherwise interfere with study procedures
Midazolam Additive to Local Anesthetic in Peribulbar Block

Regional eye blocks are usually preferred for ophthalmic procedures. Peribulbar block (PBB) is a safe alternative for patients undergoing cataract surgery. Many studies tried to solve this issue by means of prolonging the duration of action of the local anesthetics used. Several drugs were tried as adjuncts to local anesthetics, and their effects have been studied. Midazolam added to the list of adjuvant used in the subarachnoid or epidural block can produce analgesia, probably mediated by the benzodiazepine-Gamma Amino-Butyric Acid(GABA) receptor complex.

The investigators hypothesized that the addition of midazolam to lidocaine will improve the quality of the peribulbar block; fasten the onset and prolonging its anesthetic and analgesic duration.


Eligibility Criteria:
Inclusion Criteria:

* 90 adult patients with ASA physical status I to III
* Aged 40-70 years
* Scheduled for elective extracapsular or phacoemulsification cataract surgery with peribulbar block
* No history of allergy to local anesthetics
* Axial length less than 28 mm.

Exclusion Criteria:

* Patient's refusal to share in the study
* communication barrier (e.g. impaired hearing, disturbed conscious level, impaired mental status)
* uncontrolled tremors
* morbidly obese patients
* allergy to lidocaine
* coagulation abnormalities
* glaucoma
* recent surgical procedure on the same eye.