cyrilzakka/clinical-trials huggingface dataset:
Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Pulse Oximeter

The aim of the study is to compare the efficacy of T2, T3 sympathetic block using thermal radiofrequency versus chemical neurolysis in postmastectomy pain syndrome using perfusion index derived from pulse oximetry.

Postmastectomy pain is a chronic pain condition with neuropathic nature. Several drugs and methods are used for its management. This study was designed to compare the efficacy of both thermal radiofrequency and chemical neurolysis in management of postmastectomy pain through using perfusion index derived from pulse oximetry.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with postmastectomy pain syndrome
* ≥ Age 18 years
* ASA II-III

Exclusion Criteria:

* patient refusal
* coagulation defects
* abnormal kidney or liver functions
* local infection at site of injection
* bone metastases
* severe cardiorespiratory disease
Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy.

The main objective of the present study is the evaluation of the clinical efficacy of the intra-articular administration of polynucleotides in association with hyaluronic acid in the improvement of the subjective and objective manifestations of arthrosis of the temporomandibular joint compared to normal clinical management which involves Physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* patients who signed the informed consent
* age \>18;
* male and female sex;
* affected by temporomandibular arthrosis

Exclusion Criteria:

* Patients treated with painkillers and anti-inflammatories;
* patients suffering from rheumatoid arthritis with TMJ involvement;
* patients with a positive history of allergies to products of fish origin;
* patients suffering from alteration of the internal TMJ;
* patients suffering from mandibular condylar hyperplasia;
* patients suffering from myofascial pain syndrome;
* patients unable to express their consent for participation in the study;
* patients suffering from psychiatric and behavioral disorders;
* patients suffering from oncological and onco-haematological pathologies with compromised general clinical status.
Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients

The study will investigate if non-invasive continuous transcutaneous blood gas monitoring can detect tissue perfusion and hypoxemia and the relation to other circulatory parameters such as pulse, blood pressure, cardiac output and arterial saturation.

Macro circulatory parameters such as cardiac output, mean arterial pressure and arterial oxygen saturation are used to monitor the hemodynamic function and tissue perfusion in surgical patients. Though none of the methods are directly monitoring changes in the metabolism of the tissue. Arterial blood gas analysis is used as the golden standard for the detection of metabolic disturbances before, during and after surgery. Disadvantages of the method are 1) the fact that the technique is invasive to the patient, 2) that the method measures the "total gas" (each tissue's contribution to the blood gas in the total circulating blood) and 3) that the methods only provide a snapshot of the patient's blood gas status. Transcutaneous monitoring can be used as a continuous monitoring of the underlying tissue's carbon dioxide and oxygen levels in patients. The method is already used in neonates as a surrogate for the arterial blood gas analysis. Reduced tissue oxygenation due to inadequate perfusion, will initiate an anaerobic tissue metabolism resulting in low oxygen levels and high carbon dioxide levels. The transcutaneous monitoring can therefore potentially be used to detect tissue hypoxia and become a direct measurement of the underlying tissue metabolism.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing surgery for abdominal cancer
* patients undergoing femoral endarterectomy

Exclusion Criteria:

* patients not able to give a informed consent
AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184

To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the study drug. Further, the study will determine how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it when given as a single dose to healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male subjects aged between 18 and 65 years inclusive

Exclusion Criteria:

-
Study of the Safety, Tolerability and Immunogenicity of an Intranasal Influenza Vaccine Administered to Healthy Adults

The objectives of this study were to assess the safety and tolerability of DCB07010 when given intranasally at escalating dose levels of 7.5μg, 15μg, 30μg and 45μg, in combination with 22.5μg of influenza HA antigen (7.5μg HA of each of three strains) and to generate sufficient immunogenicity data to enable dose selection for larger and more definitive Phase 2 studies.

This was a single center, double-blind, randomized (2:1), dose-escalation study to assess the safety, tolerability and immunogenicity of 4 different vaccine-adjuvant doses in comparison to influenza HA alone. The 4 treatment cohorts were given DCB07010 in a dose- escalating manner.


Eligibility Criteria:
Inclusion Criteria:

1. Non-smoking adult aged between 20-40 years old;
2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest X-rays, ophthalmoscopy, cardiac echo, and electrocardiogram;
3. Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]);
4. Normal hematology, biochemistry and urinalysis determinations;
5. Subject is willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

1. Subject with serious underlying chronic illness;
2. Documented evidence of allergic rhinitis;
3. Subject with acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to enrollment;
4. Immunosuppressed subjects as result of illness or treatment;
5. Female subject of childbearing potential who:

   * is lactating; or
   * has positive urine pregnancy test at Visit 2 or Visit 3; or
   * refuse to adopt reliable method of contraception during the study;
6. Subject received blood products or immunoglobulin within 3 months prior enrollment;
7. Subjects with long-term use of steroids, including parenteral steroids or high dose inhaled steroids within 28 days prior to enrollment;
8. Subject has received any intranasal medication or nasal topical treatment within 7 days prior to enrollment;
9. Subject has received any investigational agent within 28 days or 5 half- lives, whichever is longer, prior to the first dose of investigational product;
10. Subject has previously experienced anaphylaxis;
11. Subject has allergy to eggs or prior influenza vaccine;
12. Subject with laboratory-confirmed influenza or has been vaccinated against influenza within 6 months prior to enrollment;
13. Subject with acute respiratory illness or administered antibiotics or antivirals within 7 days prior to enrollment;
14. Subject with body temperature high than 38°C within 3 days prior to enrollment;
15. Subject with documented history of Bell's palsy or neurological disorder.
16. Subject with documented history of diarrhea within one month prior to study enrollment
17. A positive test for HIV antibody.
18. Subject has received Chinese medication or herbal medication within 28 days prior to enrollment
Mobile App for Symptoms Monitoring in Cancer Patients: a Pilot Study

With the growing number of cancer survivors, challenges to deal with comorbidities and impacted quality of life of cancer survivors by the disease and treatments also surge. Symptoms and Adverse Events are common and insufficiently monitored in real time / real life, which leads to increased symptom burden, treatment delays and unplanned hospital admissions. Remote monitoring apps have been shown to improve quality of life, symptom control and survival in published clinical trials, but no data with such interventions exists on the Portuguese population.

We will conduct a pilot study to explore the feasibility of a mobile app for remote symptom monitoring in cancer patients. Patients will be recruited in Portuguese hospitals and will be invited to test the app for one month. Patient experience and satisfaction will be assessed via a weekly survey.

The results of this pilot study will inform subsequent randomized clinical trials to test safety and efficacy of remote monitoring and lifestyle interventions to improve symptoms control and quality of life.

This is a single cohort study on cancer patients to explore the feasibility of mobile app for symptom monitoring and inform future randomized clinical trials and implementation. Patients will be screened at oncology visits for inclusion criteria and will be invited to use a mobile app to monitor and track treatment side-effects.

We will recruit a minimum of 10 cancer patients under systemic anti-neoplasic treatment being followed in medical oncology departments in portuguese hospitals. between February 1st and March 30th.

Participants will be invited to register their treatment side effects and symptoms on a health app designed for this purpose.

The Mentora Health App include a PRO-CTCAE™ based tool (a patient-reported outcome measurement system developed by the National Cancer Institute), version 1.1, that includes 80 symptoms (attachment 1) and has been translated and validated to Portuguese (Portugal) by the authoring entity. These symptoms are graded on a five-point scale from 0 (not present) to 4 (disabling) based on clinical criteria.

Eligibility Criteria:
Inclusion Criteria:

* adults (18 years old or older)
* with a cancer diagnosis at any stage of any primary tumor (solid or hematologic)
* in systemic oncologic treatments of any type (including but not limited to immunotherapy, chemotherapy and targeted therapies) expected to continue for at least 4 weeks after enrolment, except when single treatment with hormone therapy for prostate cancer or breast cancer
* fluent in written Portuguese
* with a personal mobile smartphone (android or iphone)
* willing to give informed consent for study participation

Exclusion criteria:

* Cognitive impairment or disability that limits capacity to comply with study interventions and assessments as per attending physician's evaluation
* Having a life expectancy \< 3 months as determined by the attending oncologist ECOG performance status greater than 2
* Unable to read and comprehend written portuguese language
Effects of Intervention on Hope, Anxiety, and Attitudes and Behavioral Intentions of Advance Care Planning in Older Adults With Cancer

The study aims to explore the impact of advance care planning on the attitudes, behavioral intentions, hopes, and anxiety of elderly people with cancer on advance care planning with the assistance of the "Advance Care Consultation for the Elderly" manual.

The experimental group used the cartoon version of the "Advance Care Consultation for the Elderly" manual to guide the ACP process. The process included three parts: an introduction to ACP, an introduction to terminal medical care, and a discussion of what the participants wanted to do about their own health in the past, present, and future required medical care. The estimated time to lead and conduct the ACP conversation is approximately 40 minutes. The control group maintained routine care. The measurement tools are the Advance Care Planning Attitude Scale, Behavioral Intention Scale, Chinese version of Situational Anxiety Inventory-Situational Anxiety Inventory (STAI-S), and Hope State Inventory (Herth Hope Index, HHI) ). There are three measurement time points: pre-test, two weeks after intervention, and one month after intervention. Expected research results: It is expected that intervention measures can improve the positive attitudes and behavioral intentions of elderly people with cancer towards ACP while maintaining their sense of hope without increasing anxiety. It is hoped that the intervention of ACP can enhance the exploration of their own medical preferences and values by the elderly with cancer, and help them become more aware of their own choices and needs when facing treatment decisions in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients aged 65 years or older.
2. Patients currently undergoing cancer treatment.
3. Clear consciousness and able to communicate in Mandarin or Taiwanese.
4. Score of 8 points or higher (inclusive) on the Short Portable Mental State Questionnaire (SPMSQ).

Exclusion Criteria:

1. Individuals with a score of 7 points or lower (inclusive) on the Short Portable Mental State Questionnaire (SPMSQ).
2. Individuals who have not been informed about their cancer diagnosis.
Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

A surgery made by an external incision requires to stitch the subcutaneous plans, usually performed using absorbable synthetic sutures hold on wire needle. This national, prospective, multicentric, and randomized study is devoted to estimate a technique of suture of the subcutaneous plans based on an implantable medical device delivering automatically absorbable staples. This particularly innovative technique lets to expect a tolerance and an efficiency at least equivalent to the reference technique (main objective). Moreover, this technique allows to anticipate a reduction of the duration of surgical procedure and anesthetic time while limiting the risks of blood wounds of the medical staff.The medical economic part of this study will check, from the point of view of the health care hospital, wether the technique is likely to reduce the costs and time consuming theater room procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 yrs to 75 yrs
* Patient supported for a scheduled surgery :

For abdominoplasty, cervicotomy or suprapubic surgery With a open incision necessary for operative exposition of 10 cm or more with a straight or curved surgery incision

* Person covered by Health Insurance
* ECOG Performance Status 0 or 1
* Patient's informed and written consent

Exclusion Criteria:

* Incision imposing a very angular or sinuous scar for which the use of the medical device is deemed unsuited (sinuous or bayonet incisions)
* Known history of intolerance to any component of the medical device
* Immunocompromised patients or undergoing a long term treatment by corticosteroids or immunosuppressants
* Known or anticipated presence of a skin infection (due to the infected skin condition, or because of underlying surgery conducted in infected territory or likely to be)
* Dermatological disease or skin treatment in progress
* History of radiation therapy on the surgical site or antimitotic treatment in progress
* Pregnancy at the time of suture
* Patients simultaneously included in another treatment protocol
* Patients under legal guardianship
* Non French speaking patients, refusing or unfit for the monitoring proposed in the study
Chemotherapy for Patients With Osteosarcoma

The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition.

* To assess how well treatment with pemetrexed works for patients with your type of cancer
* To assess for any side effects that might be associated with pemetrexed.
* To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of high grade locally advanced or metastatic osteosarcoma
* Must have one prior chemotherapy regimen for advanced disease
* At least 1 unidimensional measurable lesion by computed tomography (CT) scan
* Have a good performance status
* Adequate organ function

Exclusion Criteria:

* Have a serious concomitant systemic disorder (for example active Human Immunodeficiency Virus infection)
* Have brain metastases not adequately treated
* Significant weight loss (that is more than 20%) over the previous 6 weeks before study entry
* Inability or unwillingness to take folic acid or vitamin B12 supplementation and corticosteroids
* Pregnant or breast-feeding
Cryoanalgesia Aplication Time Optimization During Nuss Procedure

This study compared standard therapy (multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in subject undergoing minimal invasive modyfied Nuss procedure with thoracoscopy.

Funnel chest deformation may be a great challenge for therapeutic teams due to severe pain in the postoperative period as well as chronic pain.

2 minutes per one intercostal nerve aplication cryoanalgesia as a part of multimodal analgesia is a standard protocol in many countries.

This Prospective Non-Randomized Study is a single institution pilot study designed to compare standard therapy (control side: multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in each patient to address the need for better management of acute and long-term pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method.

All of the patients will receive a standard care according to Polish guidelines: multimodal analgesia with regional analgesia (bilateral erector spine plane block) with cryoanalgesia. The right intercostal nerves will be treated with 2 minutes cryoanalgesia (control side). The left side of the chest (left intercostal nerves) will be treated with 1 minute cryoanalgesia (intervention side).

The intraoperative cryoanalgesia will be performed using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited).

The study will assess the effectiveness of shorter aplication duration time of cryoanalgesia as a method of acute and long-term pain control and safety of the method.

Specific Aim: To determine if, compared with current 2 minutes cryoanalgesia protocol, 1 minute aplication time of cryoanalgesia is effective at the same level when consider pain control and postoperative functioning in each patient.

The results were compared in terms of demographics, right versus left side of the chest pain levels, quality and length of rehabilitation and patient satisfaction using the Quality of Life by modyfied Nuss questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic Nuss technique
* informed concent signed for cryolesia

Exclusion Criteria:

* age 9 years or below
* refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief
Patient-reported Outcomes in the Treatment of Schizophrenia

Patient-reported health economic outcomes for patients enrolled in S1543003 and S1543004 protocols


Eligibility Criteria:
Inclusion Criteria:

* Participate in S1543003 and S1543004 in the U.S. sites

Exclusion Criteria:

* Participate in S1543003 and S1543004 other than U.S. sites
A Study of EDP-297 in Healthy Subjects

This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.

The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects.

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo

Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -2.
* Current tobacco smokers or use of tobacco within 1 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.
BIOFLOW-III Austria Satellite Registry

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences.

Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration.

These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease
* Subject has signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow-up assessments
* Subject is ≥ 18 years

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Pregnancy
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint is not reached yet.
D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound

To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700


Eligibility Criteria:
Inclusion Criteria:

* Healthy young men \>=25 and \<=45 years of age with a Body Mass Index (BMI) \>=18.5 kg/m2 and \<=30 kg/m2.

Other protocol-defined Inclusion and Exclusion criteria may apply.