cyrilzakka/clinical-trials huggingface dataset:
Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting

Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.

This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.

Eligibility Criteria:
Inclusion Criteria:

* With histologically or cytologically confirmed malignant disease;

  -. Be scheduled to receive the first course of MEC to be administered on Day 1
* Using reliable contraceptive measures;
* negative serum pregnancy test (if potentially child bearing)

Exclusion Criteria:

* Received investigational drugs within 30 days before the start of study treatment or scheduled to receive a highly or moderately emetogenic chemotherapeutic agent;
* Have a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication;
* Have severe renal or hepatic impairment;
* Have positive serology test results;
* Have a known contraindication to 5-HT3 receptor antagonists;
* Treated with commercially available or investigative palonosetron formulation within 2 weeks prior to start of study treatment;
* Allergic to palonosetron or any other 5-HT3 antagonist;
* Currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence as determined by the investigator;
* Will be receiving stem cell rescue therapy in conjunction with study related course of emetogenic chemotherapy;
* Received or will receive total body irradiation or radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period.
Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

BACKGROUND: Lymphedema is a pathologic soft tissue swelling that arises secondary to disruption of the lymphatic system. Lymphedema affects approximately 250 million people worldwide and causes significant physical and psychological morbidity. There is no definitive treatment for lymphedema. Lymphovenous bypass - microsurgically anastomosing lymphatic channels and venules - has demonstrated promising results in the treatment of lymphedema. PURPOSE: The purpose of this study is to determine the efficacy of lymphovenous bypass in treating extremity lymphedema. METHODS: This is a prospective, single-arm, cohort study. Eligible patients between 18-70 years of age with extremity lymphedema will undergo lymphovenous bypass. The primary outcome measure will be extremity volume and the secondary outcome measure will be quality of life assessed by a validated assessment tool for lymphedema of the limbs (LYMQOL). Patients will be assessed preoperatively and at 3, 6, 9, and 12-months postoperatively. Each participant will serve as their own control.

Primary and secondary outcome measures will be assessed with paired t-tests. With a sample size of 9 patients we will have at least 80% power to reject the null hypothesis assuming an alpha level of 0.01. To further increase the power and to account for patients lost to follow-up the investigators will target a patient recruitment of 20.

The findings of this study will help further elucidate the role of lymphovenous bypass in the treatment of extremity lymphedema.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years.
2. Lymphedema of the upper or lower extremity.
3. International Society of Lymphology Stage I-II.

Exclusion Criteria:

1. Significant comorbidities that would preclude a patient from receiving a general anesthetic.
A Multi-Center Clinical Trial in Individuals with Spinal Cord Injury

The overall objective of this project is to investigate the effectiveness of daily acute intermittent hypoxia therapy (dAIH), coupled with massed practice training, to improve upper-extremity function in individuals with chronic incomplete cervical SCI.

Specific Aim 1: Evaluate the effectiveness of a combined intervention utilizing dAIH and massed practice upper extremity training on arm and hand function in individuals with incomplete tetraplegia.

Specific Aim 2: Evaluate the effectiveness of a combined intervention utilizing dAIH therapy and robotic rehabilitation device-administered upper-extremity training on arm and hand function in persons with incomplete tetraplegia.

Eligibility Criteria:
Inclusion:

1. History of a non-progressive spinal cord injury, at or below C2, and at or above T1.
2. Between the ages of 18 - 75 years.
3. Time since injury must be at least 6 months if the injury was traumatic in nature. If the spinal cord injury is non-traumatic, participants must meet at least the initial 6-month criteria in addition to either no regression in symptoms for at least two years, per self-report or per medical monitor discretion.
4. Demonstrate voluntary motor activation in hand muscles, with a score of at least a 2 on at least one of the Prehension Ability grasp patterns of the GRASSP assessment (cylindrical grasp, lateral key pinch, and tip to tip pinch), on at least one upper extremity.
5. Ability to understand and the willingness to sign an informed consent.
6. At least a 10% change in isometric elbow strength above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during screening.

Exclusion:

1. Diagnosed with any of the following medical conditions: congestive heart failure, cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known carotid/intracerebral artery stenosis.
2. Women who are currently pregnant/nursing or planning on becoming pregnant.
3. Individuals with a tracheostomy or who utilize mechanical ventilation.
4. Individuals who are currently enrolled in another interventional research study or in therapy related to upper extremity function.
5. Participants will be excluded if they have had a botulinum toxin injection to upper extremity musculature within the last 3 months. Participants will need to refrain from upper extremity botulinum toxin injections for the duration of the study. If participants wean off antispasticity medications to successfully complete the responsiveness to AIH screening session, they will need to refrain from the medications for the duration of the study.
6. Documented sleep apnea.
7. Orthopedic injuries or surgeries that would impact an individual's ability to use the upper extremity.
8. Traumatic brain injury or other neurological conditions that would impact the study.
9. Blood hemoglobin levels less than 10g/dL.
Platelet-Rich Plasma in Acute Muscle Injuries

OBJECTIVE: To evaluate the effect of Platelet Rich Plasma (PRP) injection in muscle injuries. The investigators check football players in the acute phase of hamstrings or quadriceps injuries.

Efficacy and safety are evaluated. There are two intramuscular infiltration of PRP (Ortho pras ® system) or a homeopathic product (Traumeel ®) in each of the football players. The number of days between the date of injury and the return to play, the pain, the recurrence and the adverse reactions are registered.

STUDY DESIGN: Randomized Clinical Trial.

METHODS:

41 football players are included in the study. It is used randomly PRP injection or a homeopathic product in muscle injuries (hamstring), in the early stage (first 48-72 hours).

One week later, the investigators do a second infiltration with the same product, always ultrasound guided. 3-4 weeks after the injury, different variables are evaluated: the injurie with ultrasounds , self-perception test, muscle strength, flexibility, jump and run. It is compared the elapsed time in days in each of the groups: RETURN TO PLAY.

Furthermore, the PAIN, RECURRENCE RATE and ADVERSE REACTIONS are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old.
* Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles
* Informed consent signed

Exclusion Criteria:

* Hamstring injury (last 6 months).
* Previous infiltration in hamstring.
A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC

This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.


Eligibility Criteria:
Inclusion criteria:

1. Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
2. All lesions located in the thoracic esophagus. Secondary lesions with an absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus.
3. Clinical N0M0 with cervical to abdominal contrast-enhanced CT.
4. The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM1.
5. Aged 20 years and older.
6. ECOG Performance status 0 or 1.
7. No previous therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM (pM2) / pT1a-MM (M3) disease or pT1a-MM (M3) disease without vascular infiltration.
8. No history of radiotherapy for the neck, chest, and upper abdomen for any cancers. No chemotherapy or hormone therapy with less than 3 years of disease-free interval for any cancers.
9. Major organ function is preserved. 1) WBC\<=12,000/mm3 2) ANC\>=1,500/mm3 3) Hb\>=10.0 g /dL 4) PLT\>=10,000/mm3 5) T-bil\<=1.5 mg /dL 6) AST\<=100 IU/L 7) ALT\<=100 IU/L 8) SpO2\>=95% 9) Ccr\>=60 mL/min
10. Patients do not have a preference to receive a surgical resection as an initial therapy after receiving explanations.
11. Written informed consent is obtained.

Exclusion criteria:

1. Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curable with local therapy.
2. Active infection requiring systemic therapy.
3. Fever over 38 degrees Celsius
4. Female during pregnancy, within 28 days of post parturition, or during lactation. Male who wants a partner's pregnancy.
5. Psychological disorder, which is difficult to participate in this clinical study.
6. Receiving continuous systemic corticosteroid or immunosuppressant treatment.
7. Positive for HBs antigen or HIV antigen.
8. Diabetes mellitus, which is uncontrollable with continuous use of insulin or hypoglycemic agents.
9. Uncontrolled arterial hypertension.
10. History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
11. Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
12. Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
13. With a history of cerebrovascular disorder within 6 months.
14. Drug allergy for iodic drugs.
Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men

There are currently no published studies addressing drug-drug interactions (DDI) between masculinizing hormone therapy (MHT) and pre-exposure prophylaxis (PrEP) among transgender men (TGM). This could lead to concerns and subsequent prioritizing MHT over PrEP among TGM. Because tenofovir alafenamide (TAF) can achieve higher intracellular tenofovir diphosphate (TFV-DP) levels with lower tenofovir plasma concentrations, it is promising that both plasma tenofovir (TFV) and intracellular TFV-DP levels might not be significantly affected by MHT. The current study aims to determine the pharmacokinetics (PK) DDI between MHT and daily PrEP among TGM.


Eligibility Criteria:
Inclusion Criteria:

1. Thai nationality
2. Age 18-40 years old
3. Female-to-Male transgender individual
4. HIV-negative
5. Body mass index 18.5-24.9 kg/m2
6. Negative urine pregnancy test
7. Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft-Gault equation
8. Alanine aminotransferase (ALT) ≤2.5 x ULN
9. Signed the informed consent form

Exclusion Criteria:

1. Known history of allergy to hormonal component to be used in the study
2. Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days
3. Use of injectable MHT in the past 3 months
4. Evidence of current hepatitis B virus infection (HBV) - i.e. hepatitis B surface antigen \[HBsAg\] positive
5. Evidence of current hepatitis C virus infection (HCV) - i.e. HCV antibody positive
6. History of myocardial infarction or coronary artery disease
7. Current use of any of the following:

   * Anticonvulsants: carbamazepine, oxcarbazepine, phenytoin, or phenobarbital
   * Herbs: gingko biloba, St John's wort or milk thistle
   * Anti-infective agents: protease inhibitors, rifampicin or rifabutin
8. History of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption
9. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
The Effect of Obstructive Sleep Apnea on Medical Outcomes After Gastric Bypass Surgery

Obstructive sleep apnea (OSA) is a syndrome characterized by repetitive episodes of airway obstruction during sleep, which result in low oxygen level in the blood and bad sleep quality. Both of these effects are implicated in medical, neurological and cognitive disorders in subjects with OSA. The purpose of this study is to examine how OSA affects medical and neurobehavioral outcomes after gastric bypass surgery for weight loss in morbidly obese patients.


Eligibility Criteria:
Inclusion Criteria:

Scheduled for Laparoscopic roux-en-Y gastric bypass (RYGB) surgery Presence or absence of OSA confirmed by polysomnography Comprehension of spoken and written English

Exclusion Criteria:

Major psychiatric, neurological, or neuromuscular disorder History of untreated thyroid disease Known diabetes mellitus History of stroke with or without apparent neurological deficits Alcohol consumption which exceeds 2 drinks per day or drug abuse. Undergone a sleep study in the past
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).
* Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
* Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

Exclusion Criteria:

* History of or with active interstitial lung disease or pulmonary fibrosis.
* Active, known, or suspected autoimmune disease.
* Serious uncontrolled medical disorders.
* New onset, non-catheter-associated venous thromboembolism within the past 6 months.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions

Superb Micro-vascular Imaging (SMI) based on the iBeam platform is used to evaluate the blood supply of solid tumors. Compared with color Doppler technology, the sensitivity, accuracy and consistency of the ability of SMI to display blood flow are evaluated. Thus, the investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for diagnosing hepatic lesions, which enable to detect slow micro vascular flow inside the tumor

To evaluate the diagnostic accuracy of SMI (primary outcome) when applying on the hepatic lesion.

Each US findings during exam for patients with hepatic lesion were recorded by radiologist.

Sample size calculation according to the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Visible hepatic lesion on US
2. Agree to participate in the study
3. Accessible follow-up imaging or pathological results

Exclusion Criteria:

1. Pregnant women
Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients

This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.

Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.


Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 80 years;
* Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);
* Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA \<0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;
* No distant metastases (M0) diagnosed with PSMA-PET-CT;
* Informed consent to trial's participation and personal data treatment.

Exclusion Criteria:

* Age \<18 years old;
* Adjuvant radiotherapy;
* Previous radiation in the same anatomical site.
Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens

This will be a prospective, open-label, 125 subject (maximum), two-year multicentre investigation to assess the safety, effectiveness and rotational stability of the modified 600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥21 years of age.
* Cataract for which phacoemulsification extraction and posterior IOL implantation has been planned for the operative eye.
* Best corrected distance visual acuity (BCDVA) projected to be better than 20/30 (+0.18 logMAR) in the operative eye after cataract removal and IOL implantation.
* Calculated IOL power requirement within the range +8.0 to +34.0D
* If present, subject must have corneal astigmatism of \<1.50 D in the operative eye.
* Expected dilated pupil size ≥ 5.0 mm in diameter to visualise the axis markings
* Subject must provide written informed consent.
* Subject must be able to return for scheduled follow-up examinations for 24 months after surgery.

Exclusion Criteria:

* History of ocular trauma or prior ocular surgery in the operative eye.
* Microphthalmia
* Corneal decompensation or endothelial insufficiency
* Pseudo exfoliation
* Pars planitis
* Subjects with diagnosed degenerative visual disorders in the operative eye (e.g.,macular degeneration or other retinal disorders) that are predicted to cause future visual acuity losses to a level of 20/30 (+0.18 logMAR) or worse.
* Inability to achieve secure placement in the designated location e.g. absence of a secure peripheral anterior capsule, zonule laxity or dehiscence; posterior synechiae to the capsular bag
* Active ocular disease in the operative eye, e.g., clinically significant dystrophy, chronic severe uveitis, proliferative diabetic retinopathy, or chronic glaucoma.
* Concurrent participation in another drug or device investigation.
* Patients who are expected to require retinal laser treatment.
* Females who are pregnant, nursing or plan to become pregnant during the study.
A Disease Area Study on the Awareness and Perceptions of Systemic Inflammation and hsCRP as a biomARKer in Patients With ASCVD and CKD in China Among Cardiologists and Nephrologists

This is a survey-based study with the objective to understand the awareness, perceptions and potential clinical management patterns among Chinese cardiologists and nephrologists towards the role of systemic inflammation in patients with ASCVD and CKD in real-world clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Work in cardiology, internal medicine, or nephrology department
* Specialize in one of the following: coronary interventional cardiology, HF, general cardiology, preventive cardiology, cardiac rehabilitation or nephrology
* Practice at consultant level for 3+ years after standardized training for resident physicians or 3+ years' working experience as a specialist
* Manage at least 20 adult patients with ASCVD and CKD (not dialysis-only) every month

Exclusion Criteria:

* Unwilling to provide informed consent
* Insufficient number of patients with ASCVD and CKD
* Do not fulfil inclusion criteria.
Stabilometry and Plantar Pressures Changes After Progressive Pressure Release in Flexor Digitoum Brevis in Latent Trigger Points

The aim of this clinical trial is to check the effects of progressive pressure release in the Flexor digitorum Brevis

Eighteen subjects with bilatereal lantent myofascial trigger points wil be recruited for a pre- test post-test study. Participants will be from 18 to 40 years old, not obese. Participants will be measured before and after bilateral dry needling in Flexor digitorum Brevis. The investigators will measure stabilometry variables and static footprint. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.

Stabilometry will be measured by displacement of the center of pressures in X and Y with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with eyes open and closed, and COP speed. Two trials will be recorded for each condition and the order of the conditions will be randomized across subjects, eyes open and eyes closed. Foot plantar pressure and surface area of two static footprints will be measured during bipedal standing. Static plantar pressure will be evaluated by means of maximum pressure, medium pressure and surface area of each aspect of the foot (rearfoot, midfoot, and fore foot).

Eligibility Criteria:
Inclusion Criteria:

* Asyntomatic subjects with flat foot

Exclusion Criteria:

* Previous lower extremities surgery. History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.

Leg-length discrepancy more than 1 cm Balance deficits (determined by oral questionnaire regarding falls)