cyrilzakka/clinical-trials huggingface dataset:
Radiofrequency in Onychomycosis

Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies.

Treatments with antifungals may not be successful due to several factors, including the long time required to apply topical medications, the side effects of systemic drugs, and the application of insufficient medication to the target area. Non-ablative radiofrequency devices can be used to treat onychomycosis without harming the nail matrix cells.

Eligibility Criteria:
Inclusion Criteria:

* Onychomycosis patients

Exclusion Criteria:

Patients with excessive manual work
Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides

The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose TSEBT (12 Gy total) over a period of two weeks. After a 30 day observation period and confirmation that their disease stage has been downgraded to IA or IB, subjects will use Valchlor as a maintenance therapy over the course of one year. The efficacy of Valchlor as a maintenance drug will be followed clinically through Modified Severity Weight Assessment Tool (mSWAT) and percent body surface area measurements (%BSA). Furthermore, subjects will be followed histopathologically through skin biopsies performed at the screening visit, immediately after observation period, one month after the start of the maintenance period, and twelve months after the start of the maintenance period (4 biopsies total).


Eligibility Criteria:
Inclusion Criteria:

* 1. Male or Female
* ≥ 18 years of age
* Documentation of diagnosis as evidenced by one or more clinical features consistent with Mycosis Fungoides cutaneous T-Cell lymphoma
* Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with requirements of the study
* Skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of Mycosis Fungoides by principal investigator
* Eligible, in the opinion of the investigator, for low dose TSEBT over the course of two weeks.
* Availability of subject to be observed for up to 18 months post-screening evaluation.
* Life Expectancy greater than 6 months

Exclusion Criteria:

* Pregnant or breast-feeding females
* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
* Patients diagnosed with Sezary Syndrome. Sezary Syndrome is equivalent to mycosis fungoides that develops to Stage IVA/B with B2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than Valchlor or TSEBT.
* Patients who do not have their disease downgrade to stage IA or IB 30 days following low dose TSEBT.
* Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment
* Minimum 3 weeks since prior systematic treatment or phototherapy
* Decisionally-impaired individuals, prisoners, and vulnerable populations
NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients

This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 to 79 (inclusive)
* Have mild to moderate COVID-19-like symptoms based on the symptom list from CDC (updated May 13, 2020) and the severity categorization from FDA \[18\]:

  a) Mild COVID-19
* Fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea
* No clinical signs indicative of moderate, severe, or critical illness severity

  b) Moderate COVID-19
* Symptoms of moderate illness with COVID-19 could include any symptom of mild illness or shortness of breath with exertion
* Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths/min, oxygen saturation level \> 93% on room air at sea level, heart rate ≥ 90 beats/min
* No clinical signs indicative of severe or critical illness severity
* Directed to home isolation by study physician
* Confirm study enrollment within 7 days of symptom onset
* Practice acceptable contraception, i.e., continue with current methods if participants are already practicing contraception, otherwise participants must agree to practicing contraception with a barrier method (male or female condom) or abstinence, from Day 1 to Day 35 or 7 days after the last dose of NBT-NM108 if they do not complete the 28-day intervention.
* Have access to a smartphone, tablet, computer, or other qualifying internet-enabled device and daily internet access
* Understand and be able to follow written and oral instructions in English
* Provide informed consent

Exclusion Criteria

* Have tested positive for COVID-19 and recovered
* Receiving vancomycin monotherapy or oral broad-spectrum antibiotics
* Inability to receive oral fluids
* Self-reported allergy or intolerance to any ingredients in NBT-NM108
* Surgery involving the intestinal lumen within the last 30 days
* Documented diagnosis of celiac disease, inflammatory bowel disease or irritable bowel syndrome
* Pregnancy or breastfeeding
* Bariatric surgery
* Immunocompromised, e.g., cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled HIV/AIDS, prolonged use of steroids or other immunosuppressant medications
Intravitreal Injections of Melphalan for Retinoblastoma

Retinoblastoma treatment has become more and more focused in the last years. New treatments developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials.

Intra-arterial chemotherapy with Melphalan has shown success in some patients but with limited response when there is marked vitreal seeding. For these cases Intravitreal injections of Melphalan have been successful in Japan.

In this study the same chemotherapy (melphalan) will be administered intravitreally (directly through the eye wall) and the response (short and long term) will be monitored.

Intravitreal injections of Melphalan will be given to cases unresponsive to chemotherapy or with vitreal seeding of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Retinoblastoma that has not responded to chemotherapy
* Retinoblastoma that has vitreal seeding

Exclusion Criteria:

* previous failure of IVit Melphalan
Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation

The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. The therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of these products in the ACS with or without ST elevation, associated or not to coronarography, has clearly been demonstrated. This profit is more marked when patients are at high risk of complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high risk" for whom a coronarography is planned, in the last international recommendations of the European Cardiology Society (ESC), the American Heart Association and the American College of Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on coronarography with discordant results. The ideal delay of realization of this coronarography is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again, patients at high risk seem to benefit the more of such a strategy if it is set precociously.

Objective To compare an invasive strategy associating an early administration of tirofiban and a coronarography achieved in the 6 hours after the randomization to a conservative strategy in a population of high risk patients with ACS without ST elevation.

Design Multicentric, prospective, randomized study.

Patient's selection Patient of more than 18 years with a ACS defined by a thoracic pain of more than 20 minutes that occurred during the last 24 hours, anomalies on EKG and one of the following criteria : diabetes; recurrence of coronary pain; precocious pain post-myocardial infarction; falling of the ST segment of \> 1 mm; transient elevation of the ST segment \> 1 mm; elevation of the I troponin, T troponin or CPK MB; hemodynamic instability; ventricular arrhythmia; TIMI score \> 5

Therapeutic modes All patients receive : aspirin, clopidogrel, enoxaparine. Trinitrin and analgesics are at the clinician's appreciation. Besides, either they receive an anti GP IIb/IIIa: tirofiban (Agrastat®) and are oriented in cardiology to have a coronarography in the six hours or they are oriented in cardiology to receive the classical treatment, guided by the investigations searching for signs of myocardial ischemia.

Eligibility Criteria:
Inclusion Criteria:

* High risk ACS without ST elevation

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Persistence of the ST elevation
* Recent left branch block
* Cardiac failure or cardiogenic shock (Kilip 3 or 4)
* Treatment by anti-vitamin K
* Contra-indication to the use of one of the following treatments: aspirin, clopidogrel, enoxaparine, anti GP IIb/IIIa (tirofiban)
Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill

Evaluation of the equivalence of 6-minute walking test performed on a non-motorized treadmill to the reference test : a 6-minute walking test on a corridor.

The Six-Minute Walk Test (6-WT) is a standardized test to assess a person's functional ability to walk as far as they can in six minutes. It is widely used in the assessment of functional disability in response to medical intervention in respiratory and cardiac conditions.

This test requires a corridor measuring between 20 and 30 metres and does not require any special technical equipment or training.

While the test appears simple to set up, factors such as the length or width of the corridor, and external disruptive elements, may affect the results. Indeed, the configuration of the test site plays a role in the test result. For example, the distance traveled in a 6-minute walking test is greater on a continuous circuit than in a lane that requires people to walk back and forth or when others are using the lane (zigzags, slowdowns). In a hospital setting, while it is easy to find a corridor that is long enough, it is not always possible to dedicate it exclusively to walking tests.

An alternative would be to perform this test on a non-motorized treadmill to avoid these biases. The main objective of this study is to evaluate the equivalence of a 6-minute walking test performed on a non-motorized treadmill to the reference test in healthy subjects. In addition, a small number of patients will be invited to perform a 6-minute CT scan on a non-motorized treadmill in order to first evaluate the perception and acceptability of this new method in this population (seniors, pathologies). If the results are conclusive, a similar study with patients only will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject 18 years of age or older
* Have signed a consent form
* Be affiliated with a Health Insurance Plan
* Having a pathology requiring the monitoring of the evolution of the distance performed by 6-WT (patients only)

Exclusion Criteria:

* Being unable to walk for several minutes for physical, neurological or psychological reasons
* Recent acute coronary syndrome
* Rest tachycardia greater than 120 pulses/min.
* Resting blood pressure greater than 180/100 mmHg
* Pregnant, Parturient or Nursing Women
* Persons deprived of liberty: minors or adults who are subject to a legal protection measure or who are unable to express their consent.
* Subjects under guardianship or curatorship.
Online Exercise Program During Perioperative Treatment in Adults With Gastric Cancer

Perioperative chemotherapy with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT4) is the standard perioperative treatment for resectable and advanced gastric adenocarcinoma. Although the FLOT4 regimen have shown increases in the overall survival, response rate, and progression-free survival, it is also associated with substantial toxicities. Prehabilitation is an effective strategy to improve physical fitness in cancer patients and reverse functional limitations and inadequate levels of physical activity that are associated with worse postoperative outcomes and treatment response. Therefore, the main objective of this study is to evaluate the effects of an online, supervised exercise-based prehabilitation program on the cardiorespiratory fitness level, functional fitness and quality of life among adults with gastric cancer undergoing neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Willingness to participate in the study.
* Referral for surgical treatment for gastric cancer.
* Diagnosis of gastric cancer for curative intent - stage II/III
* Referall to the perioperative FLOT4 chemotherapy regimen
* ECOG PS 0-1.
* Receptiveness and availability to use the proposed technology for exercise sessions

Exclusion Criteria:

* Inability to provide informed consent
* Inability to engage in physical training or perform the baseline walking test
* Presence of distant metastatic disease
* History of previous or concurrent malignancy
* Diagnosis of heart failure, ischemic heart disease, or sinus node valvular disease
* Pregnancy.
A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci120 in Healthy Adults.

This study is designed to evaluate the safety, tolerability, PK and PD of GenSci120 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, between 18 and 55 years of age (inclusive) at the date of signed informed consent form (ICF), each cohort must include at least 3 participants of a single gender.
2. Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and total body weight ≥ 50 kg (Male) / ≥ 45 kg (Female) at screening.
3. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, tumor biomarker, et al.), electrocardiogram (ECG) and pulmonary imaging tests, or value beyond normal reference range considered not clinically significant.
4. Ability to understand the trial procedures, volunteer to participate in the trial, and could provide written informed consent.

Exclusion Criteria:

1. Known allergy to any component in the GenSci120 formulation, or a history of severe allergic reactions to any drugs, compounds, foods, or other substances, or a history of hypersensitivity.
2. The proposed injection site has tattoos, sunburn, scarring, or other factors that may interfere with the evaluation of the injection site.

(3) History of serious metabolic, allergic, dermatological, hepatic, renal, hematological, cardiovascular, gastrointestinal, neurological, respiratory, or other significant medical history that, in the investigator's opinion, may affect the assessment of this study.

（4）Severe infection, chronic infection, opportunistic infection, etc., within 3 months before screening, or systemic antimicrobial treatment for infections (including but not limited to viral, bacterial, fungal, parasitic infections) within 4 weeks prior to randomization.

（5）Use or intend to use any prescription medication to manage chronic/ongoing condition, and any acute medication use (including prescription medication, over-the-counter medication, or dietary supplements) within 14 days prior to administration.

（6)Participated in any clinical trials of investigational drugs (including investigational vaccines) and used investigational drugs within 3 months or within 5 terminal elimination half-lives (whichever is longer) prior to administration; participated in any clinical trials of medical devices within 3 months prior to screening (not including failed screening participants); currently participating in other clinical trials.

（7) Any other medical condition (at the investigator's discretion) that would impair the participant's ability to tolerate the IMP or proceed with the planned study procedures.
Hemostatic Profiles of Endocrine Therapies for Breast Cancer

The aim of this prospective cohort study is to evaluate the modifications of the biological hemostatic profile associated with the use of endocrine therapy in women with breast cancer (tamoxifen or aromatase inhibitors).

In this cohort study, women with breast cancer and an indication for endocrine therapy will be prospectively enrolled. At the 1st visit (before the start of endocrine therapy (tamoxifen or aromatase inhibitor)) and at the 2nd visit (at \~3 months after the start of treatment), demographical / clinical data and blood samples will be collected. We will evaluate the hemostatic biological profiles associated with the use of endocrine therapy by comparing hemostatic biomarkers before and during its use.

Eligibility Criteria:
Inclusion Criteria: adult women with a diagnosis of non-metastatic breast cancer and an indication for adjuvant endocrine therapy

Exclusion Criteria:

* lack of consent
* planned chemotherapy
* personal history of venous thromboembolism
* ongoing anticoagulant treatment
Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA

High flow, humidified, temperature-regulated nasal insufflation is not a new concept. It is used widely in the treatment of hypoxaemic respiratory failure in critically ill patients, as an alternative to non-invasive positive ventilation via face or nasal mask. Recently, its use has been extended to the perioperative setting for pre-oxygenation and prolonging apnoeic time to desaturation. Both CPAP and high flow nasal cannula insufflation devices are licensed for use clinically in Singapore. We conduct this pilot study because its perioperative use in our adult OSA population is currently not well-defined.

Continuous positive airway pressure (CPAP) therapy is the only treatment for obstructive sleep apnoea (OSA) shown to reduce its long-term adverse effects on the cardiovascular system. However, due to difficult patient-mask interface and discomfort, compliance rate amongst patients with OSA is low, and reported to be only between 20-50%. High flow, humidified, temperature-regulated nasal cannula insufflation (of air or oxygen) is a well-documented and safe treatment in intensive care, paediatrics and respiratory medicine for patients with hypoxaemic respiratory failure. Its use in adult patients with obstructive sleep apnoea, especially in the perioperative setting is not well studied. Our hospital has a ''fast-track'' protocol for OSA patients who require surgery. They are started on CPAP therapy 2 to 5 days prior to surgery and in the immediate post operative period (ie. perioperatively). If these patients are non-compliant to the CPAP mask device, high flow nasal insufflation is a possible alternative treatment. We aim to randomise these patients into 4 groups, receiving conventional CPAP face mask or high flow nasal cannula at 3 flow rates, and study them with respect to incidence and number of documented desaturations. In addition, patient satisfaction, compliance to device and any adverse events will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21-85 years old presenting for elective surgery.
* Suspected/possible OSA patients who are enrolled in the "fast-track OSA protocol" in the pre-assessment clinic
* Patients started on CPAP therapy at least one day pre-operatively
* Patients who are admitted to the High Dependency unit for postoperative monitoring.

Exclusion Criteria:

* Patients with nasal obstruction.
* Patients undergoing nasal or facial surgery, or surgery to treat OSA (eg. uvulopalatopharyngoplasty).
* Patients who already require a higher oxygen concentration (FiO2 \> 0.21) preoperatively.
Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.

The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women ≥ 18 years of age
* Diagnosed with stage IV Non-Small Cell Lung Cancer
* Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.

Exclusion Criteria:

* Subjects with untreated CNS metastases are excluded.
* Subjects with carcinomatous meningitis
* Subjects with an active, known or suspected autoimmune disease.
* Subjects with a condition requiring systemic treatment with either corticosteroids ( \> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.
* Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.

Other protocol defined inclusion/exclusion criteria apply
Impacts of Application of Virtual Reality on Gait and Balance for Stroke Patients

The goal of this clinical trial is to learn about effects of virtual reality combined with conventional therapy on the balance, gait, and quality of life in stroke patients in the subacute and chronic stages. The main questions it aims to answer are:

• Virtual reality combined conventional therapy interventions can improve the gait, balance and functional status of stroke patients or not?

Participants will asked to do about 3 tasks in virtual reality intervention

* Walk in the flat ground
* Cross the obstacle on the ground
* Cross to moving obstacles

The investigators referred to the scenes designed by previous studies to develop the three virtual environments employed in this study and made slight modifications according to Taiwan's conditions. Google Earth Virtual Reality (Google Inc., Mountain View, California, U.S., 2017) was uesd for the first and second task and Street Champ Virtual Reality (Zynk Software Srl , Cluj, Romania, 2016) was used for the third task.

Time constraints, terrain changes, and moving obstacles were set to increase the difficulty of the walking task. The speed obtained by the 10-m walking pretest was used as the training benchmark. The participants had to complete a task three times to proceed to the next level.

For Patient Registries: on-site audit.The subjects were referred from the rehabilitation Clinic of Kaohsiung Municipal Ta-Tung Hospital

Eligibility Criteria:
Inclusion Criteria:

* 1. Clinical diagnosis of Stroke. 2. Must be able to ambulation with or without devices. 3. Were able to communicate and follow instructions. 4. Were rehabilitated at Kaohsiung Municipal Ta-Tung Hospital.

Exclusion Criteria:

* 1. Limb apraxia. 2. Any vision impairments. 3. Any hearing impairments. 4. Any vestibular impairments. 5. Any comorbidities that affected movements.