cyrilzakka/clinical-trials huggingface dataset:
A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma

The purpose of this study is to evaluate the safety of olaratumab plus pembrolizumab in participants with previously treated advanced or metastatic soft tissue sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of advanced unresectable or metastatic STS, not amenable to curative treatment and after available standard therapies have failed to provide clinical benefit. Note: Participants with a diagnosis of Grade 1 liposarcoma (atypical lipomatous neoplasms) are eligible if there is histological or radiographic evidence of evolution to more aggressive disease.
* Presence of measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Must be able to provide tumor tissue obtained within 6 months of study enrollment. If such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed.
* Have an anticipated life expectancy of ≥3 months.

Exclusion Criteria:

* Have received any previous systemic therapy (including investigational agents) targeting PD-1/programmed cell death ligand 1 (PDL-1) or PD-1/PDL-2 signaling pathways (including previous participation in Merck MK-3475 trials). Prior treatment with olaratumab is allowed. Prior therapy with other immune checkpoint inhibitors, including but not limited to, anti-CD137 antibody or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody, is not permitted.
* Have known active central nervous system (CNS) metastasis and/or carcinomatous meningitis. Participants with treated CNS metastases are eligible for this study if they have not received corticosteroids and/or anticonvulsants within 7 days of study treatment, and their disease is asymptomatic and radiographically stable for at least 60 days.
* Have active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents in the past 2 years.
* History of interstitial lung disease or non-infectious pneumonia.
* Have received a live-virus vaccine within 30 days prior to planned treatment start.
* Have histologically or cytologically confirmed Kaposi's sarcoma or gastrointestinal stromal tumor (GIST).
* Have inflammatory bowel disease for which the participant has used immunosuppressive agents within the last 2 years.
Quality of Life After Transanal Endoscopic Microsurgery (TEM)

This is a observational cohort study to determine the influence of Transanal endoscopic microsurgery (TEM) on patients Quality of Life

Patients who planning Transanal Endoscopic Microsurgery (TEM) for rectal neoplasms should undergoing fecal incontinence quality of life scale and Wexner score before and after surgery for measurement their quality of life. For objectification data sphinctrometry will be perform.

Eligibility Criteria:
Inclusion Criteria:

* Have a planned of Transanal endoscopic microsurgery (TEM)
* Have signed approved informed consent form for the study

Exclusion Criteria:

* non epithelial malignancy
* recurrent neoplasm
* stoma formation
Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2

Currently one in five high school students smoke. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will examine whether reducing smoking will facilitate quitting smoking in adolescents who have unsuccessfully attempted to quit smoking

Among adolescents, the short-term health effects of smoking include damage to the respiratory system, addiction to nicotine, and the associated risk of other drug use. Adolescents are at greater risk for long-term health problems, including several types of cancer. This study will examine whether reducing smoking will facilitate smoking cessation in adolescents who have unsuccessfully attempted to quit smoking. The study will also assess whether reduction of smoking leads to continued involvement in treatment, less toxic cigarette exposure, and improved motivation and self-efficacy to quit.

Participants in this open-label study will undergo 2 weeks of baseline measurements, followed by 2 weeks of smoking cessation treatment. Treatment will involve a nicotine patch, for those who are eligible, and a standardized behavioral intervention aimed at supporting smoking cessation. Those who are ineligible to receive a nicotine patch will only receive the standardized behavioral intervention. Participants who quit smoking during the first phase of treatment will continue to receive the nicotine patches and/or the standardized behavioral intervention. Those who are still smoking after the first treatment will be randomly assigned to one of two conditions and will continue to use nicotine patches for 4 weeks. Group 1 will receive standardized behavioral therapy and will set a specific quit date. Group 2 will be encouraged to decrease smoking by 50% the first week and 75% the second week. During Week 3, participants will be encouraged to completely quit smoking. Study visits will occur weekly, at which time nicotine patches will be dispensed, standardized behavioral therapy will be provided, and standard physiological measurements will be taken. A urine sample will also be collected. Follow-up visits will be held 2 weeks, 3 weeks, and 6 months following completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Has smoked at least 5 cigarettes a day for at least 6 months
* Does not regularly use other tobacco products
* Motivated to quit smoking
* Not currently using medications to quit smoking
* Willing to use an effective form of contraception throughout the study

Exclusion Criteria:

* Informed that nicotine replacement therapy is medically inadvisable
* Diagnosed with a psychiatric disorder within 3 months prior to enrollment
* Currently taking an unstable dose of psychoactive medications
* Currently taking medications that may react with a nicotine patch
* History of alcohol or drug abuse within 3 months prior to enrollment
* Pregnant
GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles

A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles was reported to increase pregnancy and birth rates. This study was done to evaluate the reproducibility of previous findings.

GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the long GnRH agonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol, oocyte pick-up and ICSI.
* Embryo transfer performed on day 3.

Exclusion Criteria:

* Participation in another trial that was being conducted in our unit at the same time.
* Preimplantation genetic screening cycles.
* Day 5 embryo transfers.
Efficacy and Safety of Endoscopic Variceal Ligation (EVL) Versus EVL Plus Non-selective B-blockers (NSBB) For Prevention of Variceal Rebleed and Non-bleed Related Complications in Patients With Advanced Cirrhosis

The patients will be randomized into two groups

1. Endoscopic Variceal Ligation with Non Selective Beta Blocker
2. Placebo with Endoscopic Variceal Ligation


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 80 years old.
* Clinical criteria and/or analytical, ultrasound and/or liver biopsy consistent with the diagnosis of liver cirrhosis.
* Endoscopic Diagnosis of esophageal variceal bleeding within 5 days prior to study inclusion.
* Written informed consent to participate in the study.
* Child C status, CTP \>10

Exclusion Criteria:

* Pregnancy or lactation
* Serum Creatinine \> 2 mg/dl
* Bleeding due to gastric varices.
* Active infection or recent infection \< 2 weeks
* Presence of hepatocellular carcinoma or portal vein thrombosis
* Active alcoholism
* Pregnancy
* HIV infection
* Severe heart, respiratory or contraindications for beta blockers(severe chronic obstructive pulmonary disease, severe asthma, severe insulin-dependent diabetes mellitus, Brady arrhythmia)
* Not giving consent
Ginseng HRG80 in Stress and Fatigue

This study evaluates the effects of a specific herbal preparation of Panax ginseng in preventing symptoms of stress in healthy individuals.

HRG80 is an herbal preparation of Panax ginseng with a higher concentration of bioavailable ginsenosides than typical Korean ginseng. This study will test whether HRG80 is effective at preventing symptoms of stress, such as fatigue, impaired memory, difficulty in concentration, attention deficit, restlessness, and irritation related to daily work situations of healthy individuals in comparison to placebo and a standard Pananx ginseng with a lower concentration of ginsenosides.

Eligibility Criteria:
Inclusion Criteria:

* Individuals experiencing at least one symptom of stress and fatigue during 8 hours of mental work with a computer.
* Men and women ages 18-65 (all races and ethnicities)
* Able to understand and participate in an 11-week study

Exclusion Criteria:

* Taking medicine or dietary supplements which may have potential effects on cognitive function
* Consuming more than 1 cup of coffee daily (in the morning).
STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)

This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.

A large lipid core is the hallmark of coronary plaques at risk of rupture and subsequent atherothrombosis. Although statin-based medical treatment is known to regress and stabilize lipid-rich coronary plaques, it takes time for such beneficial effects to appear. This study aims to investigate whether DCB angioplasty can effectively modify de novo coronary atherosclerotic plaque and lead to reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with significant multivessel coronary artery disease requiring revascularization
* Any De novo lesions (reference vessel diameter of 2.25mm\~4.0mm) suitable for DCB angioplasty
* Lesion suitable for intravascular imagings
* Written informed consent

Exclusion Criteria:

* Hemodynamically unstable or cardiogenic shock
* Left main stenotic lesion or graft vessel lesion
* Visible angiographic thrombus, not resolved by balloon angioplasty
* Pregnancy or breastfeeding
* Comorbidities with life expectancy \< 12 months
* Severe coronary calcification or tortuosity, hindering timely DCB delivery
Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients

Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU outcome.

Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU survival.

A single-centre prospective observational cohort will be performed with consecutive patients, elective and non elective, admitted to the ICU between 1st June 2018 and 1st June 2019. Demographic data, APACHE III, comorbidity and phase angle are collected and the ICU- , hospital- and 6 months survival will be registered.

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to the ICU, elective and acute.

Exclusion Criteria:

* age below 18
* Length of stay at ICU \< 6 hours
* All invalid bio-impedence analysis (BIA) measurements
Erector Spinae Plane Block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic Subcostal transverse abdominis plane block (STAP) is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and STAP in laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II-III
* Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* obesity
* ASA IV
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs
* Inability to provide informed consent
* Severe kidney or liver disease
* Inability to operate PCA system
* Patient with psychiatric disorders
Do It Yourself (DIY) Coffee Study; Test Effect of Coffee on Cognition in an at Home Setting

Subjects will perform experiments in an at home-setting. The effect of caffeine in coffee will be tested in subjects with computer tests on attention and alertness. Comparison of the results with published results from controlled experiments will indicate the effectiveness of home experiments.

There is increasing interest in the general public in measuring health parameters at home, instead of in a medical setting. Many tests for measuring health parameters are commonly available in drug stores as well as online. When structured, this trend may also be used for performing a randomized intervention trial.

The current study is aimed to evaluate the procedure of performing a non invasive intervention study by subjects themselves performing the tests at home.

The study is designed as a randomized, placebo-controlled, double blind, crossover study.

Subjects have to consume a cup of coffee after an overnight fast. Coffee will be prepared from instant coffee containing either regular coffee or decaff coffee. Each intervention will be given twice.

Effects on alertness and attention will be established by three computerized tests provided by Quantified Mind. The tests will be performed by the subjects at t=0 (baseline, prior to coffee consumption) and t=1h, one hour after coffee consumption, in one go. Each test will be performed during 5 minutes. During the training session the participants will be instructed to get acquainted with the task.

The evaluation of the study concerns the effect of caffeine in the at home setting versus published results, as well as reproducibility of the results.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy as assessed by the:

   * health and lifestyle questionnaire
2. Adult age (\>18y)
3. Able to perform computerized tests
4. Voluntary participation
5. Having given written informed consent
6. Willing to comply with the study procedures
7. Moderate caffeine users
8. Able to use a desk top or laptop with internet access at home
9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data 10 Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

1. Having a history of medical or surgical events that may significantly affect the study outcome, including attention (ADHD etc), psychological or psychiatric disorders
2. Physical, mental or practical limitations in using computerized systems
3. Use of concomitant medication including medication known for its effects on mood and/or attention (anti-depressives, sleep medication, etc)
4. Alcohol consumption \> 28 units/week for males and \> 21 units (drinks)/week for females
5. Personnel of TNO of location Zeist or of location Soesterberg, their partner and their first and second-generation relatives
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine

This is a randomised, placebo controlled, double blind, crossover proof of concept study to investigate the efficacy and safety of oral LAT8881 in acute migraine, with or without aura.

Subjects enrolled in the study will be randomised to receive investigational medicinal product (LAT8881 60 mg or placebo), to be taken at the onset (within one hour from the onset of pain) of a migraine headache of moderate to severe intensity \[Numeric rating scale greater than 4\]. Rescue medication should not be taken until at least 2 hours post dose. Subjects will be given a single dose of either active or placebo, to treat one migraine headache.

After treatment of one migraine headache (or a maximum 28 days) the subject will return to the clinic for re-evaluation and crossover to the second treatment. After treatment of one migraine headache in the second treatment period or a maximum of 28 days from commencement of the second treatment period, the subject will return to the clinic for re-evaluation. An End of study visit (telephone) will occur 7 days after the end of the second treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18 to 75 years at the time of consent
2. Diagnosis of episodic migraine headache at least 12 months ago with or without aura as defined in International Classification of Headache-3
3. Onset of migraine headache before age 50
4. Medical history of 2 - 8 migraine headache attacks per month for the previous 12 months; ≥ 75% of attacks progress to moderate or severe pain within 2 hours (ie, rapidly-escalating)
5. Minimum 48 hours on average between migraine headache attacks
6. Acute headache medication on ≤ 14 days/month in the 3 months prior to screening
7. Willing and able to comply with all study procedures including completion of a headache diary and a migraine diary on the day of a migraine headache

Exclusion Criteria:

1. Unable to distinguish migraine from other primary headache conditions
2. Average of 15 or more headache (migraine or nonmigraine) days per month or history of more than 25% of headaches occurring at time of wakening (wake up headaches)
3. History of aura lasting more than 60 minutes
4. History of vomiting within 2 hours of onset of a migraine headache in more than 25% of migraine headaches
5. Medication overuse headache, defined as:

   1. use of opioids, triptans or ergot alkaloids or any combination of these medications for treatment of headaches 10 or more days per month during the 90 days prior to screening OR
   2. Non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics for treatment of headaches on more than 14 days per month during the 90 days prior to screening
6. Recent (3 years) history of frequent or chronic hemiplegic/ basilar migraine, tension headache, retinal migraine, ophthalmoplegic migraine as per ICHD classification, or treatment resistant atypical migraine
7. Hospital admission for status intractable migraine or medication overuse headache within 6 months of screening
PMRA and Shapley-Based Machine Learning for Predicting Lymph Node Metastasis in Central Subregions of Clinically Node-Negative Papillary Thyroid Microcarcinoma: a Prospective Multicenter Validation and Development of a Web Calculator

Background:Management of clinically node-negative(cN0) papillary thyroid microcarcinoma (PTMC) is complicated by high occult lymph node metastasis (LNM) rates. We aimed to develop and validate a prediction model for central LNM using machine learning (ML) and traditional nomograms through Probability-based Ranking Model Approach (PMRA).

Methods: We conducted a prospective multicenter study involving 4,882 patients across 3 hospitals (2016-2023). After applying inclusion criteria, 1,953 patients from the primary center were allocated to model train and test (7:3 ratio). External validation included prospective cohorts of 286 and 176 patients from two independent centers.13 ML algorithms and traditional nomogram models were systematically evaluated using PMRA.We compared models using preoperative features alone versus those incorporating both preoperative and intraoperative frozen section pathology data. Feature selection utilized six methods, with L1-based selection proving optimal for most predictions.Model interpretability was enhanced through SHapley Additive exPlanations (SHAP) visualization.


Eligibility Criteria:
Inclusion Criteria:

* First-time thyroid cancer surgery patients
* cN0-PTMC patients diagnosed through fine-needle aspiration and imaging.

Exclusion Criteria:

* Secondary surgery
* Other pathological types of thyroid cancer
* Incomplete clinical data
* Distant metastasis or history of cervical radiation exposure.