cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB3, IIA2).

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB3, IIA2), by a multicenter stratified randomized controlled study, mainly including the following aspects:

1. To compare the differences in PFS and OS between patients receiving LRH and ARH.
2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).
3. To assess postoperative complications and quality of survival.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB3,IIA2).
2. Age ≥ 21 years and ≤ 70 years.
3. Surgery type B and C (refer to Q-M surgical staging)
4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin \> 60g/L Platelets \> 70\*109/L Leukocytes \> 3\*109/L Creatinine \< 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.
5. No history of other malignancies.
6. Non-pregnancy.
7. Physical strength classification: Karnofsky score ≥ 60;
8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI)

Exclusion Criteria:

1. Those who are contraindicated for various surgeries and cannot undergo surgery.
2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
3. Patients with recurrent cervical cancer
4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter \>2cm after further improvement of preoperative examination.
The Effectiveness of Cross-training on an Immobilised Forearm

The cross-training phenomenon is the increase in muscle strength in the contralateral limb when one limb is exercised. Limited studies have shown that it prevents immobilisation-induced muscle weakness in healthy volunteers. The aim of this study was to evaluate the effect of strengthening the contralateral extremity on muscle strength and range of motion in the immobilised extremity in patients who had undergone immobilisation for forearm fractures.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic unilateral forearm fracture (treated surgically or conservatively and immobilised in a cast)

Exclusion Criteria:

* Previous upper limb surgery/joint disease - deformity affecting hand-wrist function
* Any neurological condition affecting the upper extremity (stroke, Parkinson's disease; multiple sclerosis, reflex sympathetic dystrophy, peripheral nerve injury)
Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

This observational study is a large-scale, prospective, and multi-institutional observational study.

Patients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.

Data will be collected based on patient's medical records from daily visit. Enrolled subjects will take a Patient Reported Outcome (PRO) survey including Quality of life evaluation (GERD-HRQL) and self-awareness symptom (RDQ).

The survey will be done twice (before and after the administration of Fexuclue tablet) electronically through an application (e-PRO).

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged 19 years to 75 years (on registration date)
2. Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
3. Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
4. Patient who agreed to participate in this observation study and signed Informed Consent Form

Exclusion Criteria:

1. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet

   * Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof
   * Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations
   * Pregnant and lactating women
   * Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
2. A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
3. In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study
Observational Study to Assess a 6-months Treatment With Gladem

* Evaluation of a 6-months treatment with Gladem
* Experiences with the internet for performing a postmarketing study (PMS) trial


Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years old
* De novo prescription of Gladem
* Treatment with Gladem intended for at least 6 months
* Depressive disorders

Exclusion Criteria:

* Known hypersensitivity against sertraline
* Concomitant treatment with monoamine oxidase (MAO)-inhibitors, selegiline, moclobemide (washout for at least 14 days necessary)
* Concomitant treatment with other serotoninergic substances like tryptophan or fenfluramine
* Instable epilepsy

According to product information (October 1998) Gladem prescription was possible with precautions in the following cases:

* Patients with stable epilepsy
* Patients with restricted liver functions
* Suicidal patients
* Patients in emotional state and marked sleeping disorders

According to product information (October 1998) Gladem should only be prescribed during pregnancy and lactation period, if the expected benefit was greater than the risk. Women of childbearing age should use Gladem only in combination with sufficient contraception.
An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.


Eligibility Criteria:
Key Inclusion Criteria:

* Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
* Complete resection within 13 weeks prior to the first dose of pembrolizumab
* Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
* Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Normal organ and marrow function reported at screening

Key Exclusion Criteria:

* Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry
* Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted)
* Live vaccine within 30 days prior to the first dose of pembrolizumab
* Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample
* Active autoimmune disease
* Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
* Solid organ or allogeneic bone marrow transplant
* Pneumonitis or a history of (noninfectious) pneumonitis that required steroids
* Prior interstitial lung disease
* Clinically significant heart failure
* Known history of human immunodeficiency virus (HIV)
* Known active hepatitis B or C
* Active infection requiring treatment
UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

UV1 is a therapeutic cancer vaccine that has been explored in prostate and lung cancers, and in combination with ipilimumab in malignant melanoma. This study will explore the safety, tolerability and efficacy of UV1 administered with GM-CSF in melanoma patients who are also receiving pembrolizumab.


Eligibility Criteria:
Key Inclusion Criteria:

1. Stage IIIB, IIIC or IV melanoma
2. Previously untreated and eligible for pembrolizumab treatment (prior treatment with BRAF and MEK inhibitors permitted) 3) Adequate blood, liver and kidney function 4) Consent to undergo tumor biopsies during the study

Exclusion Criteria:

1. Uveal or ocular malignant melanoma
2. History of hematologic or primary solid tumor malignancy with the exception of patients in remission for at least 5 years, as judged by the investigator are allowed
3. Prior systemic treatment for unresectable or metastatic melanoma. Exception: Prior treatment with BRAF and MEK inhibitors permitted. A washout period of at least 3-half-lives (median terminal half-life) prior to the first dose of trial treatment must have elapsed.
4. Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or oncolytic virus.
5. Known hypersensitivity to GM-CSF
6. Women who are breastfeeding, pregnant or expect to be pregnant during the study through 6 months after the last dose
7. Men who plan to become a father during the study through 4 months after the last dose of study medication
8. Known history of, or any evidence of active, non-infectious pneumonitis
9. History of cardiac disease
Comparison of Duloxetine Versus Pregabalin

Chronic post mastectomy pain syndrome (PMPS) is a chronic post-surgical neuropathic pain following breast cancer surgeries and lasting more than three months after surgeries. Pregabalin is originally used as an antiepileptic drug and identiﬁed as treatment for neuropathic pain .There are several recent reviews have revealed that it reduces post-operative opioid consumption and improves pain scores after breast surgeries. Duloxetine is a serotonin and norepinephrine reuptake inhibitor. Its mechanism of action is related to the potentiation of serotonergic and noradrenergic activity in the descending inhibitory pain pathways of the central nervous system and used for treatment of neuropathic pain conditions as painful diabetic neuropathy, neuropathic pain of lung cancer and chemotherapy induced sensory neuropathy

Patients with of 3 months of chronic neuropathic pain after breast surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection is considered as post mastectomy pain syndrome which is defined as pain involving the anterior aspect of the chest, axilla, and/or upper arm with the classical features of neuropathic pain including numbness, tingling, burning, shooting, stinging, or stabbing pains, and hyperesthesia.

* They are divided to 2 equal groups: ( Group A) receive duloxetine for 12 weeks and (Group B) control group receive pregabalin for 12 weeks .
* Dosing and administration Group A) Duloxetine 30 mg /day at bed time and (Group B) control group Pregablin 150mg /day( 75 mg /12 hours )
* Randomization and blinding: Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.
* Concomitant therapy :opioid therapy according to WHO step ladder in cancer pain

Eligibility Criteria:
Inclusion Criteria:

* Female, history of breast surgery and patients with post mastectomy pain

Exclusion Criteria:

* pregnancy,history of allergy to Pregabalin or duloxetine, pregnancy or lactation, history of pregabalin or gabapentin intake in the preceding three months, history of radiotherapy and history of drug abuse
Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis

This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

Chronic rhinosinusitis (CRS) is a chronic inflammatory disease of the sinus mucosa. Chronic rhinosinusitis can be clinically divided into chronic rhinosinusitis without nasal polyps (CRSsNP) and chronic sinusitis with nasal polyps (CRSwNP), with an incidence ratio between the two of about 4:1. Patients with CRSwNP usually show more severe clinical symptoms and are more likely to relapse after surgery. The overall prevalence of chronic rhinosinusitis in our country is 8%, of which 11.2% are accompanied by asthma. The prevalence of chronic rhinosinusitis with nasal polyps (CRSwNP) is 1.1%. With changes in the living environment and acceleration of urbanization in China, the overall morbidity is estimated to keep rising.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged between 18 and 75 years old (inclusive).
* Subjects who are capable of understanding the nature of the study and voluntarily signing the Informed consent form (ICF).
* Prior treatment with systemic corticosteroids (SCS) within two years before screening, and/or contraindicate to or intolerance to systemic corticosteroids, and/or with prior surgery to nasal polyps 6 months before the screening.

Exclusion Criteria:

* Allergic or intolerant to mometasone furoate spray or CM326.
* Have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period.
* Participated study of CM326.
* Systemic immunosuppressive therapy for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to baseline (whichever is longer).
* Starting leukotriene receptor antagonist therapy within 4 weeks prior to baseline.
* With antrochoanal polyps.
* With severe deviation of the nasal septum occludes at least one nostril.
* With persistent rhinitis medicamentosas.
* With acute sinusitis, nasal infection, or upper respiratory tract infection at screening.
* Have symptoms or whose CT scan suggests allergic fungal sinusitis.
* With malignant or benign neoplasm of nasal cavities.
* With other uncontrolled serious diseases or recurrent chronic diseases.
* Have severe hepatic and renal impairment.
Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Stroke
* Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm

Exclusion Criteria:

* Acute Stroke
* Contracture or orthopedic problems limiting the movement of the affected arm
* Visual deficit such that the participant cannot see the test pattern on the robot trainer
* Serious complicating medical illness
* Botox treatment to the involved arm within three months of enrollment
Management of Myopia in University Students Using Dual Focus Soft Contact Lenses

The purpose of the study is to quantify the effectiveness of Coopervision MiSight contact lenses in slowing the rate of myopia progression in university students.

MiSight contact lenses have been shown to be a safe and effective way of managing myopia progression in children aged 8-12 years. However, myopic progression is not limited to children of this age group and MiSight lenses have also been shown to be effective in older children aged 11-16 years. There is evidence that progression also occurs in university students. The researchers are therefore investigating the effectiveness of this intervention in a group of UK-based University students.

Eligibility Criteria:
Inclusion Criteria:

* Be a myopic students studying at university
* Be aged 18-21 years at the start of the study
* Show evidence of recent myopia progression prior to commencement of Stage 2 of the study.
* Have read the patient information sheet and be happy to sign the consent forms
* Be willing to adhere to the visit schedule and wearing times described in this protocol
* Agree to lens wearing times of at least 10 hours per day, 6 days per week
* Agree to accept either the control or test lens as assigned by the randomisation
* Have BCVA of +0.10 logMAR or better in each eye

Exclusion Criteria:

* Previous myopia control use (optical or pharmacological)
* Amblyopia
* Ocular pathology such as keratoconus or recurrent corneal infections
* Myopic Rx \> 10D
* Astigmatism \>1D
* Anisometropia \>1.75D
* Binocular Vision anomalies (such as Tropia)
* Medications that affect pupil size or accommodation
* A known allergy to fluorescein or tropicamide
* Biomicroscopic findings that would contraindicate contact lens wear
* The investigator considers that it is not in the best interest of the subject to participate in the study.
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia

The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.

Febrile neutropenia remains a major cause of morbidity in solid cancer patients. There is an unresolved question regarding the appropriate duration of antibiotic treatment for patients with febrile neutropenia of unknown origin. Current guidelines recommend at least seven days of antibiotic treatment. Several studies have demonstrated the safety of early antibiotic discontinuation in patients with febrile neutropenia. We plan an open label randomized controlled trial to compare early antibiotic discontinuation to the accepted prolonged antibiotic treatment protocol

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years providing signed informed consent
* Patients with solid tumors, lymphoma, multiple myeloma or chronic lymphocytic leukemia, regardless of disease status or previous chemotherapy
* Documented febrile neutropenia
* No clinically or microbiologically documented infection after 72 hours

Exclusion Criteria:

* Previous enrollment in this study
* Concurrent participation in another interventional trial
* Severe sepsis or septic shock
* Acute leukemia, autologous or allogeneic hematopoietic stem-cell transplantation
* Diarrhea suspected by treating physician to be Irinotecan induced
* Any antibiotic treatment for \>48h in the last week before enrollment
TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

This prospective, randomized controlled trial aims to evaluate the efficacy and safety of Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) for patients with frequent premature ventricular coomplexes (FPVCs). Ninety participants will be randomized to TAVNS group and sham-TAVNS group with the ratio of 1:1. They will receive TAVNS plus usual care or sham-TAVNS plus usual care for 6 weeks, and then be followed up for 12 weeks after the treatment. The primary outcome was the proportion of participants with a 50% decrease of the 24 hour (24h) premature ventricular complexes (PVCs) after 6-week treatment. Secondary outcomes include the proportion of participants with a 75% decrease of the 24h-PVCs; the decrease from baseline of 24h-PVCs, total 24h-heartbeat, and the frequency of supraventricular arrhythmia; the score change from baseline in PVCs-related symptoms; the score change from baseline in SAS and SDS. Subgroup analyses will be performed in age, gender, and the severity of PVCs. Safety assessment will be documented during the whole trial.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as frequent premature ventricular contractions;
* 2 ≤ Lown level ≤ 4A;
* 18 ≤ age ≤ 75;
* Volunteered to participant

Exclusion Criteria:

* Severe valvular disease, congenital heart disease, pericardial disease, hypertrophic cardiomyopathy, unstable angina pectoris, acute myocardial infarction, myocarditis, aneurysm, congestive heart failure decompensation period (NYHA grade III or VI), cardiogenic shock, cerebrovascular disease, hematopoietic system disease, severe mental disease;
* Bradycardia, including pathologic sinus node syndrome, degree II or greater atrioventricular block;
* Those who have already had pacemaker or percutaneous coronary intervention, or who plan to have pacemaker or percutaneous coronary intervention;
* Pregnant or lactating women;
* Local sensory deficit, or allergic to current;
* May be allergic to percutaneous patches；
* Blood pressure ≤ 90/60 mmHg;
* Those who have participated in other clinical trials within 3 months.
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis

This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic OA pain of shoulder (gleno-humeral)

Exclusion Criteria:

* Patients with current or prior conditions or treatment that would impede measurement of efficacy or safety
Vilazodone for Treatment of Geriatric Depression

The purpose of this study is to examine the effects of vilazodone for the treatment of depression in older adults.

This is a 12-week double-blind comparison of a novel antidepressant, vilazodone, to the gold-standard drug, paroxetine, for the treatment of geriatric depression. We are interested in assessing the difference in response to vilazodone (VLZ) compared to paroxetine (PAR). We hope to detect difference in response in primary outcomes (depressed mood) and secondary outcomes cognition. We are seeking to examine this directly in 80 older adults (60 years of age or older) with major depression with anticipated 60 completers. This proposed trial will serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and use this project for dose-finding in this population.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
* A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline
* Mini-Mental State Exam (MMSE) score \> 24.

Exclusion Criteria:

* Subjects will be excluded if they had any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or recent unstable medical or neurological disorders; any disabilities preventing their participation in the study; diagnosis of mild cognitive impairment (MCI)/dementia; those with known allergic reactions to paroxetine or vilazodone.