cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Biomarkers for Radiation Therapy

The purpose of this study is to determine whether specific assays of DNA damage repair proteins can be used in patients undergoing radiation therapy. The ultimate goal of this research is to develop clinically useful biomarkers from blood samples that could be used to customize radiation treatment for individuals, leading to reduced side effects and improved outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years of age with primary lung, esophageal or rectal cancer receiving neo-adjuvant chemoradiotherapy before planned resection
* patients with clinically localized prostate cancer receiving definitive radiation therapy with external beam treatment. brachytherapy as a boost and/or hormonal therapy are allowed.
* patients with head and neck, lung, esophageal or cervical cancer who will receive definitive radiotherapy

Exclusion Criteria:

* prior history of chemotherapy given within 6 months before enrollment.
* prior radiotherapy or radionuclide treatment and/or brachytherapy within 6 months prior to enrollment.
* unwillingness to comply with tests, protocol, or informed consent.
* concurrent enrollment on any protocol that would require non-compliance with treatment procedures.
* chemotherapy required within 2 hours following first dose of XRT.
* PET scan done within 48 hours of first blood draw.
* nuclear medicine exposure within 4 days prior to first draw.
Long-term Survival After Single-ventricle Palliation

A nationwide observational study. Children operated with single-ventricle palliation between January 1994 and December 2017 operated in Sweden will be included retrospectively. Patients born with a functionally single ventricle but not undergoing surgery will not be included. Data regarding preoperative clinical characteristics and operative details will be obtained by medical records review and from The Swedish Registry of Congenital Heart Disease (SWEDCON). Using unique personal identity numbers assigned to all residents of Sweden, data from SWEDCON will be linked with dates of death.


Eligibility Criteria:
Inclusion Criteria:

* Operated with single-ventricle palliation between January 1994 and May 2017 in Sweden.

Exclusion Criteria:

* None.
Microdevice for Evaluating Drug Response in Site in Lung Lesions

This is a pilot study for placement of a tiny microdevice into lung tumors to more precisely predict tumor-specific drug sensitivity, and to help inform systemic therapeutic decisions. The microdevice will provide a novel technique for interrogating human lung tumor tissue in situ, and will uniquely facilitate assessment of response to multiple drugs simultaneously. This will not only increase the specificity of a particular participant's chosen systemic therapy, it will also augment the speed and efficiency with which investigators are able to make clinical decisions regarding choice of therapy.

The initial aims in this pilot study will focus on the safety and feasibility of microdevice placement and retrieval in participants with suspicious lung lesions. The microdevice, which is 5.5 mm in length and approximately 750 µm in diameter (i.e., comparable in size and shape to commonly used fiducial markers), will be placed in the suspected tumor tissue at the time of surgical resection. Multiple agents will passively diffuse into local, confined regions (several microns) of the surrounding microenvironment. The agents are released at approximately one millionth of a systemic dose. The device(s) will be removed for analysis at the time of resection, which will be performed for clinical indications independent of enrollment in this study. The investigators will collect data regarding the safety and feasibility of the placement and retrieval of the microdevices, and perform detailed tissue analysis of drug response. Investigators hope to compile preliminary data regarding correlations between in situ drug response and the genetic and histopathologic features of tumors, systemic treatment response, and ultimately, clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a suspicious lung lesion for which surgery is indicated for either diagnostic or therapeutic purposes, as determined by the treating thoracic surgeon
* Masses with a minimum longest dimension of 1 cm
* 18 years of age or older
* Documented, signed, dated informed consent for both the surgical resection as well as the proposed research study obtained prior to any procedures

Exclusion Criteria:

* Subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection in the opinion of the treating surgeon
* Women of childbearing potential without a negative pregnancy test; or women who are lactating
Circadian Variations of Prostaglandin in Sleep Apnea

The purpose of this study is to evaluate the associations of circadian variations, sleep architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction during sleep that provoke frequents arousals, sleep fragmentation, oxygen desaturation, and excessive daytime sleepiness. OSA may contribute to the development of systemic hypertension, cardiovascular disease. Many studies has reported a crucial role for the prostaglandin D system in sleep regulation. In addition, it has been described urinary or blood levels of prostaglandins was higher in the patients with hypertension, diabetes mellitus, and these values were associated with the severity of coronary artery disease. However, the relation between alterations of prostaglandin D system and sleep architecture, sleepiness, and clinical outcomes such as hypertension, arteriosclerosis in the patients with OSA are not known. Additionally, after CPAP treatment, we will investigate the association between change of prostaglandin system and sleep architecture, sleepiness, clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
* Subjects diagnosed with OSA (apnea hypopnea index \>=5/hour) by overnight polysomnography.

Exclusion Criteria:

* Subjects treating for acute infections or malignancy.
* Subjects with severe cardiovascular disease, diabetes,and renal failure.
* Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants.
Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

This is a prospective observational study of patients undergoing planned surgery for intestinal failure. The aims of the study are:

* To prospectively characterise preoperative bacterial populations amongst patients undergoing surgery for intestinal failure
* To examine the relationship between preoperative bacteriology and surgical site infection (SSI) in this patient group
* To investigate the effect of surgery and surgical site infection on generic and wound specific quality of life measures


Eligibility Criteria:
Inclusion Criteria:

* Adults aged \>18 year
* Diagnosis of intestinal failure or enterocutaneous fistula
* Undergoing elective surgery within St Mark's hospital IF unit

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Pregnant
Daratumumab to Treat Active Lupus Nephritis

The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in patients with active lupus nephritis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age.
* Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria.
* Renal biopsy confirming the diagnosis of active class III/IV (± class V) LN (based on International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003) within 12 months of enrollment.
* Proteinuria ≥ 500 mg over 24 hours.
* eGFR ≥ 30 ml/min/SA.
* Subjects should be able to give informed consent.

Exclusion Criteria:

* Pregnancy.
* Hepatitis B or C, HIV
* Anemia with Hgb \< 8.0 g/dL.
* Thrombocytopenia with platelet count \< 100'000.
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication.
* Unable to provide consent.
* Patients receiving \> 10 mg of oral prednisone or glucocorticoid equivalent if on corticosteroids for \> 2 weeks (patients would be allowed to be on \> 10 mg of prednisone or its oral equivalent as long as the duration is ≤ 2 weeks).
* Patients who had received immunosuppressive therapy including cyclosporine, tacrolimus or azathioprine in the last 3 months.
* Patients who have received cyclophosphamide in the last 6 months.
* Patients who received rituximab previously with CD20 count of zero at the time of enrollment.
* Patient are allowed to be on MMF at time of enrollment but no higher than total of 1500mg/day.
* For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 12 months after the last dose of study drug.
* For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period.
* Patients with diagnosis of glaucoma.
EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet Obstruction Caused by Malignant Neoplasms

The objective of this investigation is to compile clinical experience on the use of the Evolution® Duodenal Stent (Cook Ireland), a CE marked device intended for the palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms. It is not the goal to change the usual treatment practice of the investigator or the center, nor to collect information on uses outside the product's indications. Patients will be treated as per usual medical practices.


Eligibility Criteria:
Inclusion Criteria:

* Patients for whom this device would be chosen in standard practice

Exclusion Criteria:

* Patients for whom this device would not normally be chosen in standard practice
A Digital Intervention (ACT on Vaping App) for Vaping Cessation in Young Adult E-Cigarette Users

This clinical trial evaluates a smartphone application (app) called Acceptance and Commitment Therapy (ACT) on Vaping for helping young adults quit using electronic cigarettes (e-cigarettes). E-cigarettes pose numerous risks, particularly to youth and young adults. Addressing the high prevalence of e-cigarette use by young adults requires effective and accessible treatments to support current users to quit. Research shows this group prefers and benefits from newer methods of treatment delivery such as digital interventions. ACT on Vaping is a digital therapeutic intended to deliver behavioral therapy to young adults who vape to motivate and support abstinence from all nicotine and tobacco products. The app contains sessions that promote awareness of cues that trigger tobacco use and teach skills for responding to these triggers in a way that is tailored for the participant's readiness to quit. Receiving access to the ACT on Vaping app may be effective in helping young adults quit vaping.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use the ACT on Vaping app (Version A) and receive a text messaging program to motivate and support quitting. Participants also receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status.

ARM II: Participants use the ACT on Vaping app (Version B) and receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status.

After completion of study intervention, participants are followed up at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-30
* Age of majority (to provide informed consent) in current state/territory of residence
* Current weekly user of e-cigarette product(s) for the last 30 days
* Has a smartphone; either an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)
* Experience downloading and using one or more apps on their smartphone
* Have a mobile data plan and/or access to WiFi to support the use of the ACT on Vaping app
* Has access to text messaging
* Has an email address
* United States (US) resident, with a US mailing address
* Willing to complete all study procedures
* Comfortable reading and writing in English

Exclusion Criteria:

* Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatment is allowable during trial participation)
* Member of the same household as another research participant
* Currently in prison
* Google voice number as sole phone number, due to its association with fraudulent study entry attempts
* Is ineligible per fraud prevention protocol
* Employees/family of investigator or study center
Impact of Hot Flashes on Sleep and Mood Disturbance

We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-45 years old
* Premenopausal
* Willingness to use barrier methods of contraception during study and after completion of study until menses resume
* Good general health

Exclusion Criteria:

* Pregnancy or currently breastfeeding
* Hot flushes
* Mid-luteal phase progesterone \<3ng/mL
* Clinically significant abnormalities in screening blood tests
* BMI \> 35 kg/m2
* Previously diagnosed osteoporosis or osteopenia
* Clinically significant depressive symptoms
* Psychiatric illness
* Sleep apnea or periodic limb movement of sleep (PLMS)
* Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
* Current or recent use of centrally active medications
* Current or recent use of systemic hormone medications
* Night shift workers
* Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood
* Abnormal vaginal bleeding
* History of any medical diseases that may put subject at risk when treated with study medication.
Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

This study will examine a proposed research treatment which evaluates the addition of oxaliplatin, a chemotherapy agent, to gemcitabine, another chemotherapy agent, and radiation therapy for the treatment of patients with pancreatic cancer. The researchers have already done studies using gemcitabine and radiation therapy together. They want to build on the information they have from this previous research. The researchers believe that the combination chemotherapy with radiation is worth investigating to treat pancreatic cancer. They will use this study to determine what type of side effects occur with this treatment and to assess how effective the treatment is at controlling the cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
* Patients may have any stage of pancreatic cancer but if metastatic, systemic disease burden should be asymptomatic and small in volume.
* Determination of resectability must be made prior to registration.
* Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod performance status of \< = 2.
* Patients must have adequate organ function defined as follows: absolute neutrophil count of \> = 1500/mm3, platelets \> = 100,000/mm3, serum Cr \< = 1.5 mg/dl, bilirubin \< 3.0 mg/dl, with relief of biliary obstruction if present (PTC tube or endobiliary stent).
* Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
* Patients of reproductive potential must have agreed to use an effective contraceptive method during participation in this trial and for 6 months after trial.
* Patient must be aware of the investigational nature of the therapy and provide written informed consent.

Exclusion Criteria:

* Patients with neuroendocrine tumors are excluded.
* Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
* Patient must not have used any investigational agent in the month before enrollment into the study.
Evaluation of the Effectiveness of New Management Techniques in Reducing Dental Anxiety for Children Undergoing Pulpotomy

The goal of this clinical trial is to reduce dental anxiety for sixety six children undergoing pulpotomy in primary molars by using kaleidoscope glasses and Tell-Show-Play-Doh techniques and evaluation of behavior and anxiety achieved by using FLAAC scale, measuring heart rate and RMS-Pictorial scale.


Eligibility Criteria:
Inclusion Criteria: 1. Children attended the dental clinic for their first time.

2. Children aged between 4 to 6 years including both boys and girls. 3. Healthy Children with Frankl's behavior rating score 2,3 and 4 of Frankl's behavior rating scale and no prior dental experience.

4. Children with carious lesions in lower restorable primary molars and indicated for pulpotomy.

- Exclusion Criteria: 1.Children with known significant visual impairments or psychological problems.

2. Children suffering from systemic diseases or special health care needs.
The Effects of Serratus Anterior Plane Block on Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery

Postoperative pain still remains a challenging problem in patients undergoing video-assisted thoracoscopic surgery (VATS). However, there is no gold standard for regional analgesia for VATS. Serratus anterior plane block (SPB) under ultrasound guidance has been described recently to achieve complete paresthesia of the hemithorax. Therefore, SPB has the possibility to provide analgesia following thoracic surgery. Pain following surgery is a critical side effect of surgery, which increases the risk of complications and delays a recovery. Therefore, SPB may help not only reduce pain following VATS, but also increase the quality of recovery. This study aims to investigate the effectiveness of ultrasound-guided SPB on the quality of recovery and pain in patients undergoing VATS.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (20-65 years of age) scheduled for elective video-assisted thoracoscopic surgery
2. ASA class I and II

Exclusion Criteria:

1. Allergy to local anesthetics or contraindication to use of ropivacaine
2. Pregnancy
3. Neurologic and psychologic disease
4. Severe cardiovascular disease
5. Liver failure
6. Renal failure
7. Chronic treatment with analgesics
Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients. The main question it aims to answer are: 1. if the wound related events, including wound dehiscence, infection, delayed healing is significant less often in patients receiving second stage operation via axillary approach compared with primary breast approach; 2. if the aesthetic outcome is comparable between patients receiving different approach for second stage operation. To answer these questions, the breast cancer patients have received nipple-sparing or skin-sparing mastectomy and had breast tissue expander insertion via breast incision, will be prospectively recruited, and randomized into two groups while receiving implant exchange operation: (1) operate via axillary incision; (2) operate via primary breast incision.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 + (inclusive)
* Female
* Invasive breast cancer or ductal carcinoma in situ was confirmed by preoperative pathology
* SSM/NSM (skin sparing/nipple and areola sparing mastectomy) combined with expander implantation has been performed within a year
* An incision on the surface of the breast is used to place an expander in the first-stage surgery
* There is no clinical or radiological evidence of distant metastasis
* Expander removal combined with prosthesis implantation is planned
* Able and willing to sign an informed consent

Exclusion Criteria:

* The first SSM/NSM combined expander implantation was performed via axillary approach
* Patients participate in other clinical trial, which could potentially affect their participation in this trial
* Adjuvant radiotherapy was planned post-operation
* Patient who is pregnant and lactating
* The expander is not sufficiently expanded pre-surgery (does not reach more than 90% of its volume)
Suprascapular and Axillary Versus Interscalene Blocks Regarding Phrenic Affection in Shoulder Surgeries

This study is aims to compare between combined suprascapular and axillary nerve blocks versus interscalene nerve block regarding phrenic nerve affection assessed by ultrasound guided diaphragmatic excursion in shoulder arthroscopy surgeries.

Interscalene approach of brachial plexus nerve block is recognized as the gold standard technique for postoperative pain control after shoulder arthroscopy surgeries . However, it is associated with major adverse effects and possibly critical complications including phrenic nerve affection. Combined suprascapular and axillary nerve blocks are considered to be a safe and effective alternative to interscalene nerve block for shoulder surgery. Futher studies had been done regarding postoperative analgesia after shoulder arthroscopy surgeries using intersalene nerve block versus suprascapular and axillary nerve blocks.

In this study, we will Compare between combined suprascapular and axillary nerve blocks vs interscalene nerve block regarding objective phrenic nerve affection known as a serious complication of interscalene nerve block.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 - 60 years old.
* Both sexes.
* ASA physical status classes I - II.
* Body mass index: 18-35 kg/ m2.

Exclusion Criteria:

* Infection at site of injection.
* Psychiatric illness.
* Central Nervous System Diseases like (epilepsy, stroke ...etc.) or neurological disease affecting patient's upper limb.
* Dependence on opiates and psycho-dynamic medications.
* Moderate to severe pulmonary disease.
* Coagulopathy and bleeding disorders.
* Allergies to drug used (Bupivacaine 0.5%).
* Previous surgery at site of injection and history of radiotherapy.