cyrilzakka/clinical-trials huggingface dataset:
Laser Treatment of Basal Cell Carcinoma

Laser treatment of Basal cell carcinoma

The purpose of this pilot study is to examine the treatment of superficial basal cell carcinoma (BCC) with laser technology. The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects 18 years of age or older
2. Lesion is biopsy-proven superficial BCC \<= 2.0 cm in largest diameter
3. BCC is on trunk or extremities
4. Seeks and is scheduled for treatment of BCC
5. Willing to have photographs taken of the treatment area
6. Ability to understand and the willingness to sign a written informed consent document
7. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion Criteria:

1. Subjects with a BCC lesion that requires excision. This would include relatively larger lesions (\>2.0 cm in diameter), high risk lesions as defined by American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
2. Pregnancy
3. Subjects unable to follow-up for the full 12-months
4. Subjects not willing to have biopsy taken from the treatment area
5. Subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome
Endo-Band: Endoscopic Band Ligation for Weight Loss

To the best of our knowledge, this is the first study to use endoscopic band ligation for weight loss. All ligatures will be performed in the gastric body starting at the distal body; 5 parallel rows, with the last one in the proximal body.The entire procedure can be completed in 30 min. Oxygen is used for endoscopic air insufflation.Endoscopy is performed using propofol for sedation.

The idea of band ligation of the gastric body is to induce multiple gastric ulcers that forms a fibrotic scars which can lead to marginal narrowing of the lumen; same as that occurred in the esophagus following band ligation of esophageal varices or in the antrum following band ligation of GAVE.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 27

Exclusion Criteria:

* Any contraindication for endoscopy
* Any gastric bleeding lesions
* Uncontrolled use of anticoagulants or NSAID's
Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.


Eligibility Criteria:
Inclusion Criteria:

* Advanced/metastatic solid tumors, for which no effective standard therapy exist
* Adult patients (age \>/= 18)
* ECOG performance status (PS) 0 or 1
* Life expectancy of at least 3 months
* Adequate renal, liver function and bone marrow reserve
* Prior cancer therapy allowed, with max 4 regimens of chemotherapy. Washout: at least 4 wks (6 wks for nitrosoureas, mitomycin C and liposomal doxorubicin) and all toxicities recovered to CTC Grade \</=1
* Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
* Women and men of child producing potential should agree to use effective contraception
* Capability to swallow capsules intact

Exclusion Criteria:

* Known uncontrolled/symptomatic brain metastases
* Currently active second malignancy
* Major surgery in the last 4 wks
* Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
* Pregnancy or breast-feeding women
* Known active infections
* History of drug allergic reactions
* Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption.
* Documented gastrointestinal ulcer
* Other severe concurrent acute or chronic medical or psychiatric condition that could compromise protocol objectives
Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-Up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins

This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison.

The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.

The interest \& relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.

Eligibility Criteria:
Inclusion Criteria:

* male or female subjects of Chinese origins
* aged 21 years or older
* with healthy skin;

Exclusion Criteria:

* skin pigmentation which interferes with the reading of skin reactions
* with sunburn, eczema, atopic dermatitis, perioral dermatitis, or rosacea on the area to be treated
* with a washout period for the following topical treatment(s) Corticosteroids, oher anti-inflammatory drugs, retinoids
* with a washout period for the following systemic treatment(s): Medications that may increase photosensitivity, corticosteroids, anti-inflammatories, retinoids
Topical Psoriasis Study for Patients Receiving Biologic Therapy

A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks.

Adult male and female subjects with moderate to severe chronic plaque psoriasis All patients will receive Topicort® BID for 4 weeks.

After week 4 patients will receive Topicort® BID on two consecutive days a week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults ≥ 18 years of age.
2. Diagnosis of chronic plaque-type psoriasis.
3. Able to give written informed consent prior to performance of any study related procedures.
4. Treated with a biologic agent for a minimum of 24 weeks at baseline.
5. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
6. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
7. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

1. \>5% Body Surface Area
2. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
3. Pregnant or breast feeding, or considering becoming pregnant during the study.
4. Malignancy or history of malignancy, except for:

   1. treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas;
   2. treated \[ie, cured\] malignancy with no evidence of recurrence within the previous 5 years.
5. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
6. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
7. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
8. Patient received UVB phototherapy within 2 weeks of Baseline.
9. Patient received PUVA phototherapy within 4 weeks of Baseline.
10. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
Assessing Fitting Guides in Alcon Multifocal Contact Lenses

The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent;
* Normal eyes;
* Current full-time soft contact lens wearer needing presbyopia correction;
* Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
* Eye conditions (past or present) as specified in the protocol;
* Currently wearing Alcon multifocal (MF) contact lenses;
* Only one eye with functional vision;
* Contact lens wear in one eye only;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Other protocol-defined exclusion criteria may apply.
Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes

to compare methods of induction of labor in fetal growth restriction and its effect on maternal and neonatal outcome

Intra uterine growth restriction (FGR) is a condition in which the fetus does not realize its growth potential in uterus. The excepted definitions of this condition are fetal weight estimation below the 10th percentile per gestational week. Severe growth restriction is defined as estimated weight below the 3rd percentile. It is well known that fetuses which are growth restricted are subjected to a higher degree of complications during pregnancy and delivery such as fetal distress, hypoxic damage, intra uterine fetal demise and complications in the neonatal period including prolonged NICU hospitalization, cerebral palsy, hypoxic ischemic encephalopathy and also long term affects such as neuro developmental complications.

Common practice in managing these cases is induction of labor at term around 37 weeks of gestations to prevent these complications as it established that during this time there is a substantial rise in pregnancy complications including fetal demise.

There are no clear guide lines how to induce labor in such cases and it is not known what is the safest and the most effective way to induce labor in these cases. Prior studies have found the rate of successful vaginal birth in these cases vary between 50 and 80%. There are a number of methods of labor induction and delivery available including the use of vaginal prostaglandins (PGE2) for cervical ripening, intracervical balloon catheter or planned cesarean. In most cases when aiming for vaginal delivery the choice is between ripening of the cervix with balloon catheter in combination with Pitocin or ripening with prostaglandins. It is not known which method is safer and more successful in growth restricted fetuses.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* fetal growth restriction defined as estimated fetal weight between the 3rd and 10th percentile per gestational age and are intended to deliver vaginally
* Gestational age between 36 and 42 weeks
* No known fetal anomalies

Exclusion Criteria:

* Fetal estimated weight below the 3rd percentile
* Known fetal anomalies
* Contraindications for vaginal delivery: breech presentation, abnormal Doppler flow velocimetry of fetal ductus venosus.
* Oligohydramnios defined as amniotic fluid index below 5 cm
* Contraindication to the use of prostaglandins
* Fetal distress requiring emergent cesarean section
* All other condition preventing vaginal delivery as decided by a senior physician
Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI

The purpose of the study is to quantitatively characterize the flow in the pelvic venous structures using 2D and 4D flow MRI with the objective of establishing physiologic and pathologic parameters for downstream computational fluid dynamics analysis.

Arm 1: To establish the baseline flow characteristics of the iliac veins in patients with no imaging evidence of iliac venous disease.

Arm 2: To assess the flow characteristics of the iliac veins in patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome).

Arm 3: To assess the flow characteristics of the iliac veins in patients status post iliac stent placement.


Eligibility Criteria:
Arm 1: Inclusion Criteria:

• No self-reported history of pelvic or iliac venous disease or associated symptoms

Exclusion Criteria:

* History of pelvic or iliac venous disease or intervention
* Contraindication to MRI examination
* Prisoners
* Subjects ≤ 18 years of age
* Pregnant women
* Adults unable to provide informed consent

Arm 2: Inclusion Criteria:

• Clinical symptoms or imaging findings compatible with left iliac vein compression syndrome

Exclusion Criteria:

* History of pelvic or iliac venous intervention
* Contraindication to MRI examination
* Prisoners
* Subjects ≤ 18 years of age
* Pregnant women
* Adults unable to provide informed consent

Arm 3: Inclusion Criteria:

• History of left iliac vein stent placement

Exclusion Criteria:

* Contraindication to MRI examination
* Prisoners
* Subjects ≤ 18 years of age
* Pregnant women
* Adults unable to provide informed consent
Development of Upper Aerodigestive Tract Splint

The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.

This is a pilot study of 30 patients. We will tabulate the data for efficacy, there will be no statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Require a procedure involving the upper aerodigestive tract (UADT)

Exclusion Criteria:

* Prior surgery to tongue or mouth that precludes the use of the splint
* Trismus with mouth opening that does not allow for use of the splint
* TMJ dysfunction that precludes the use of the splint
* Allergy to local anesthetic
Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery

The investigators' hypothesis is that restriction of circulating fluids in comparison to a liberal fluid administration policy would lead to a reduction of allogenic red blood cells exposure in patients undergoing cardiopulmonary bypass (CPB) for primary coronary artery bypass graft supported by reinfusion of washed shed blood from thoracic cavities.

192 patients operated under equal conditions were assigned prospectively and randomly either for a restrictive protocol for intravenous fluid administration (group A, 100 patients) or not (group B, 92 patients). Transfusion guidelines were common for the two groups. The volumes of intravenous fluids, priming, "extra" volume on pump and cardioplegic solution and the volume of urine were recorded. Net erythrocyte volume loss was calculated. The number of the transfused PRC was analyzed as a continuous variable. "Transfusion" was analyzed as a categorical characteristic. Analysis employed Student's two-tailed t-test, t-paired test and chitest.

Eligibility Criteria:
Inclusion Criteria:

* Ejection fraction (EF) of left ventricle (LV) \> 35%
* Preoperative serum Creatinine \< 150 μmol/l
* Preoperative Haemoglobin \> 10/dl
* Peripheral anastomosis scheduled =\< 3

Exclusion Criteria:

* redo bypass-emergency operations
* prior coronal stenting
* active congestive heart failure
* documented Myocardial Infraction within the previous 6 weeks
* NYHA class \> 3
* Carotid stenosis \> 50%
* CVA
* INR \> 1.5
* chronic obstructive pulmonary disease (COPD)
* Steroid therapy-chronic inflammatory process
* Use of aprotinin or tranexamic acid
Comparative Trial of Home-Based Palliative Care

Background: To effectively alleviate suffering and improve quality of life for patients with serious illness and their caregivers, palliative care (PC) services must be offered across multiple settings. Research is needed to determine how best to optimize home-based palliative care (HBPC) services to meet the needs of individuals with high symptom burden and functional limitations.

Aim: The investigators will compare a standard HBPC model that includes routine home visits by a nurse and provider with a more efficient tech-supported HBPC model that promotes timely inter-professional team coordination via synchronous video consultation with the provider while the nurse is in the patient's home. The investigators hypothesize that tech-supported HBPC will be as effective as standard HBPC.

Design: Cluster randomized trial. Registered nurses (n\~130) will be randomly assigned to the tech-supported or standard HBPC model so that half of the patient-caregiver dyads will receive one of the two models.

Setting/Participants: Kaiser Permanente (15 Southern California and Oregon sites). Patients (n=10,000) with any serious illness and a prognosis of 1-2 years and their caregivers (n=4,800)

Methods: Patients and caregivers will receive standard PC services: comprehensive needs assessment and care planning, pain and symptom management, education/skills training, medication management, emotional/spiritual support; care coordination, referral to other services, and 24/7 phone assistance.

Results: Primary patient outcomes: symptom improvement at 1 month and days spent at home in the last six months of life; caregiver outcome: perception of preparedness for caregiving.

Conclusion: Should the more efficient tech-supported HBPC model achieves comparable improvements in outcomes that matter most to patients and caregivers, this would have a lasting impact on PC practice and policy.


Eligibility Criteria:
Patient Inclusion Criteria:

* Serious illness with 12-24 month life expectancy
* Homebound
* Need for skilled nursing care (only at KP Southern California)
* English or Spanish speakers

Patient Exclusion Criteria:

- Currently receiving HBPC

Caregiver Inclusion Criteria:

* Non-professional family, friend or other caregiver
* English or Spanish speakers
Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week


Eligibility Criteria:
Inclusion Criteria:

* Males and females 12 - 75 years of age with a diagnosis of persistent asthma
* Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent
* FEV1 at Visit 1 at least 50% of the predicted normal value
* FEV1 reversibility at least 15%

Exclusion Criteria:

* Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years
* Chronic Obstructive Pulmonary Disease (COPD)
* Seasonal allergy where asthma is likely to deteriorate during the period of the study
* Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months
* A respiratory tract infection within the previous 6 weeks Other protocol-defined exclusion criteria may apply
Application of Telemedicine to the Management of Aggressive Lymphomas

The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started
* a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP).
* Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible.
* accepting the study

Exclusion Criteria:

* Patient with another type of lymphoma (including transformed follicular forms)
* Patient having already started his treatment.
* Life expectancy \<3 months.
* Carcinologic history
* Serum positive for HIV or hepatitis B virus (HBV).
A Survey About Trade-offs When Choosing Menopause Treatments

This study is an online survey of women in menopause with moderate to severe hot flashes. Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.

This study is about collecting information only. There will be no treatment in this study. This study will provide information on the trade-offs women are willing to make when deciding which treatment or treatments work best for them.

Women from Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden and the United Kingdom (UK) will take part in this study.

Women will be recruited through a third-party recruitment company.

Most women will be asked to complete an online survey. Before the survey is sent to the women in the study, it will be tested by a small group of women. This group will be asked to take part in a telephone interview while taking the survey. They will be asked to say their thoughts aloud while completing the survey. Researchers will record this and also take notes. The aim of the interview is to check that the survey is understood by the women before it is sent out to the rest of the women.

The survey will have 3 sections: Firstly, the women will answer questions about their experience with menopause and their symptoms. Next, they will be shown pros and cons for specific treatments for their menopause symptoms. The women will be asked to choose which treatment they would prefer, based on this information. Finally, they will answer questions on how their menopause symptoms have impacted their lives.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden, or the United Kingdom
* Experience at least 14 moderate or severe VMS episodes associated with menopause per week (or 2 to 3 episodes per day)
* Self-reported completion of natural menopause (post-menopausal)
* Willing and able to provide consent to take part in the study; Speak native language of country of participation
* Telephone interview only: Willing and able to participate in a telephone interview, and be audio recorded

Exclusion Criteria:

* Experienced treatment related menopause either as a result of medical or surgical intervention
* Difficulty understanding or communicating in the language(s) of Australia, Canada, Denmark, France, Italy, Spain, Sweden, or the United Kingdom
* Online survey only: Participation in the Telephone interview