cyrilzakka/clinical-trials huggingface dataset:
Local Excision Versus Total Mesorectal Excision In Pathological Complete Response (ypT0-1cN0) Mid- Or Low-Rectal Cancer After Neoadjuvant Therapy

Patients with cT2-4aN0-2M0 mid- or low-rectal cancer received neoadjuvant chemotherapy or combined chemoradiotherapy. Good responders (cT0-1N0) patients received local excision 4-8 weeks after treatment. Pathologically verified ypT0-1 patients are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). The composite end points include 3 year disease-free survival (DFS), overall survival (OS), recurrence, major morbidity and quality of life.

Total mesorectal excision is still the standard surgical treatment of mid-and low advanced rectal cancer after neoadjuvant treatment. This radical procedure inevitably has the risk of major short and long term morbidity and anorectal function impairment. Additionally, abdominal perineal resection(APR) with permanent stoma is still applied to some low rectal cancer patients, even though major response had been achieved after neoadjuvant treatment. Previous studies have proposed "wait and see" strategy in clinical complete response patients. The local recurrence rate is still high due to residue adenocarcinoma lesion.

Local excision is a conservative alternative approach associated with low mortality and morbidity and high quality of life. In this study, the investigators proposed local excision in good responders (cT0-1N0) 4-8 weeks after neoadjuvant treatment. Patients with pathologically verified complete response (ypT0-1cN0) are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). The purpose of this prospective randomized controlled study is to compare local excision versus total mesorectal excision in pathological complete response (ypT0-1cN0) mid- or low-rectal cancer after neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

* 1、Willing and able to provide written informed consent. 2、Histological or cytological documentation of adenocarcinoma of the rectum (≤8 cm from the anal verge).

  3、ypT0-1cN0 after neoadjuvant therapy 4、No metastatic disease. 5、Patient is at least 18 years of age. 6、Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7、Non complicated primary tumor (obstruction, perforation, bleeding).

Exclusion Criteria:

* 1、T1, T4 tumour or anal sphincter invasion 2、Metastatic disease (M1) 3、Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy 4、Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study 5、History of cancer
Single Dose Study of PF-04991532 in Healthy Subjects

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK) and preliminary food effect of PF-04991532 following single escalating oral doses in healthy adult subjects.

Safety/Tolerability and PK

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Self-reported history of hypoglycemia, or fasting laboratory glucose value \</=80 mg/dL at screening or Day 0 of Period 1, confirmed by a single repeat if deemed necessary.
Diet and Exercise in Pompe Disease

This study examines the effects of individualized diet and exercise plans on muscle strength, quality of life and respiratory function in Pompe disease. Subjects will be given a diet and exercise plan based on their individual needs, which will be followed for 16 weeks. Participants will also be provided with an activity tracker in order to track their exercise activities, access to an app that will allow them to input their daily food intake, and they will also come to the University of Florida for exercise tests, respiratory tests and questionnaires.

Pompe is a rare disease, which occurs in approximately 1 in 40,000 births. It is a progressive and often fatal neuromuscular disorder resulting from a mutation in the gene for acid alpha- glucosidase (GAA), an enzyme necessary for the degradation of glycogen. Common symptoms include skeletal and smooth muscle myopathy, resulting in respiratory insufficiency, peripheral muscle weakness and generalized fatigue.

The progressive myopathy in Pompe disease seems to be influenced by increased muscle protein breakdown. The increased muscle protein breakdown leads to muscle wasting, weakness, increased resting energy expenditure and, consequently, increased fatigue. Our hypothesis is that a high protein, low carbohydrate diet associated with regular physical exercise will improve respiratory and peripheral muscle functions in Pompe disease.

In this study, we will investigate the effects of 16 weeks of planned diet and exercise in adolescent and young adult (15-55 years old) individuals with Pompe disease using an activity tracker.

The participant will be asked to come to the University of Florida 4 times throughout the study (screening, baseline, +/- 15 days of completing the diet and exercise plan and a follow up three months later) for exercise testing, quality of life questionnaires, respiratory function testing and blood draws.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 15-55 years of age;
* Have a diagnosis of Pompe disease, as defined by protein assay and/or DNA sequence of the acid alpha-glucosidase gene, with present clinical symptoms of the disease;
* Be naïve to ERT or receiving ERT for at least eighteen months prior to beginning study;
* Be able to walk at least 40m in the 6 minute walk test.
* Willing to comply with study requirements

Exclusion Criteria:

* Be pregnant;
* Be in the lower limit for pulmonary function; FVC \< 30% predicted;
* Be dependent on assisted ventilation;
* Be dependent on wheelchair;
* Have evidence of clinical heart failure;
* Have any contraindication to exercise
Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant

This clinical trial studies the feasibility of implementing a telehealth exercise platform to reduce frailty in patients after bone marrow transplant.

The exercise program uses a telehealth platform (e.g. smart phones, tablets or computers) to view pre-recorded exercise videos on coordination, posture, stretching, balance and resistance/aerobic training.

Physical activity may help to improve physical function, including frailty, after bone marrow transplant. Information from this trial may help researchers design future telehealth exercise routines for treating people with cancer.

PRIMARY OBJECTIVE:

I. Determine the feasibility of the telehealth exercise program, as evaluated by participation and completion rates.

SECONDARY OBJECTIVE:

I. Explore the effects of the telehealth exercise program on physical functioning.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients participate in telehealth exercise sessions at home over 30 minutes with a trainer 3 days a week for 8 weeks (24 total sessions).

ARM B: Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age at the time of study enrollment
* \>= 2-years from hematopoietic cell transplantation (HCT) and in clinical remission
* Identified as pre-frail or frail based on Bone Marrow Transplant Survivorship Study (BMTSS) questionnaire (i.e. clinically underweight, exhaustion, low energy expenditure, slow walking speed, and muscle weakness), with the presence of \>= 3/5 indices classified as frail and 2/5 indices classified as prefrail
* Able to understand and sign the informed consent document
* Physically able and willing to complete all study procedures
* Has access to the internet and a smartphone
* English speaking

Exclusion Criteria:

* Overt cardiovascular disease (e.g. myocardial infarction, stroke, angina)
* Contraindications to exercise (acute infectious disease, physical disability preventing safe performance \[assistive devices\], cognitive impairment or inability to cooperate)
* Participation in regular exercise (\> 60 minutes per week)
* Female who are pregnant or planning to become pregnant
Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

The aim of this study is to compare the success rates of vaginismus therapy using a tampon or a dilator during exposure

Tampon Group

Exercises will be performed with tampon

Dilator Group

Exercises wil be performed with dilator

Eligibility Criteria:
Inclusion Criteria:

* non-pregnant/non lactating women aged between 18-50
* diagnosed with primary vaginismus of Lamont level II or higher

Exclusion Criteria:

* hymenal abnormalities, congenital vaginal abnormalities, vulvodynia, secondary vaginismus following physical or psychological trauma, infection, menopausal period or pelvic pathology and with any psychiatric or physiological disease.
* Patients with husbands possessing a history of sexual dysfunction (erectile dysfunction or premature ejaculation, for example)
Tonsillotomy or Follow-up in PFAPA Syndrome

Children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) -syndrome diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months follow up. At follow up visit 3 months after randomisation the children from either groups with ongoing symptoms will be sent to tonsillectomy.

Children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) -syndrome diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months follow up.

In both groups the symptoms are monitored with symptom diaries. At follow up visit 3 months after randomisation the children from either groups with ongoing symptoms will be sent to tonsillectomy (total remove of palatine tonsil).

The design is sequential trial. From the previous trials we know that the effect of tonsillectomy is about 90% and that during follow up for six months as much as 50% of the patients will recover. Because the syndrome is rare and because the rescue operations of the tonsils (tonsillectomy in a person who has gone through tonsillotomy), the sample size has to be as low as possible. That is the reason why we chose sequential design, with assessments after every 8 patient.

Randomization is made in blocks of four. In sequential design we use the following assumptions:

* We are looking for a 40% absolute difference in cure rate between tonsillotomy (90%) and follow up (50%) groups.
* Two sided Whitehead design
* Maximum likelihood estimation (MLE)
* Five assessments (sample size 4+4, 8+8. 12+12, 16+16 and 19+19)
* type 1 error 5 % and power 80%
* The sample size will be from 8 to 38 patients depending on when the trial can be stopped along assessments.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed PFAPA syndrome: regularly occurring fever episodes for 3-5 days for at least five times or for 6 months

Exclusion Criteria:

* prior tonsil surgery
Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia

The purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural labor analgesia, and find out the optimal dose of hydromorphone.

Participants will be randomly allocated to four groups : Group 1, Group 2, Group 3 and Group 4. For those in Group 1 : they will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 2 : they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine for epidural labor analgesia.

The goal of this clinical trial is to provide a new treatment option for pregnant women in epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine in epidural labor analgesia.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status II
* a single fetus
* competent to provide informed consent

Exclusion Criteria:

* severe respiratory diseases including hypoxemia, respiratory failure and severe pneumonia
* severe circulatory diseases including acute decompensated heart failure and peripartum cardiomyopathy
* placenta previa
Pediatric Intubation

The aim of the study was to compare time and success rates of TruView PCD video laryngoscope and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios in a standardized manikin model.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* inexperienced in pediatric intubation paramedics

Exclusion Criteria:

* not meet the above criteria
* participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience
The Feasibility of Using the PulsePoint to Facilitate Overdose Education and Naloxone Distribution

This study is a feasibility trial to assess whether, in a random sample of 180 agencies where PulsePoint is already active, revised procedures (hereinafter PulsePoint-OD) to facilitate opioid overdose and naloxone distribution (OEND) can successfully recruit first responder agencies and layperson responders. For this study, agency refers to a single implementation site where PulsePoint is active and that is bound by the service area or jurisdiction of the first responder agency collaborating with PulsePoint.

The study will test the following hypotheses:

H1: more first responder agencies will be successfully recruited by arm 2 than by arm 1.

H2: more layperson responders will report engaging with OEND programming in arm 2 than in arms 1 or 3 and in arm 1 than in arm 3 \[only this hypothesis is covered by the IRB, hypothesis 1 is not human subjects research\].

A full, detailed description of the study protocol and preregistered procedures is located in our formal protocol paper (https://doi.org/10.2196/57280) which is also cited at the end of this specific registration.

All specific language throughout this document is derived directly (verbatim) from the protocol paper, which is our controlling, planned preregistration document for this project.

Eligibility Criteria:
Layperson responders who are part of the PulsePoint system register with a local first responder agency using their smartphone. Anyone who is registered with a PulsePoint agency randomly selected for this project is included. Most layperson responders (eg, those who are not also off-duty first responders themselves) are only alerted to incidents in public spaces. No identifying information is collected from these users except the unique ID of the device.
The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye

The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment.

The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment. At the same time, this study further observed whether 0.05% cyclosporine eyedrops combined with artificial tear eyedrops were more beneficial to ocular surface repair and tear film homeostasis compared with traditional artificial tears alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients who suffering from dry eye after refractive surgery with age between 18 and 45 years old.
* Any gender.
* Provision of written informed consent.

Exclusion Criteria:

* active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
* Pregnant and lactating women, or those planning a pregnancy over the course of the study.
* Uncontrolled systemic disease.
* Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.
Medical Abortion for Emergency Contraception Failure

The purpose of this study is to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical termination of pregnancy by mifepristone EC failure.

Women usually request an abortion when they have experienced an emergency contraception (EC) failure; this population represents 13% of all early pregnancy terminations in China. Many women would prefer to choose a medical abortion in order to avoid anesthesia, over a surgical operation. However, medical termination of a pregnancy after mifepristone EC failure has not been studied although it has already been extensively practiced by empirical means in China. There is no clarification in literature as to whether mifepristone is still effective in medical abortion with its previous failure experience in EC. This randomized study was aimed to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical termination of pregnancy by mifepristone EC failure.

Eligibility Criteria:
Inclusion Criteria:

* Participants included in the study were women aged 16 years or older
* with good general health,
* experiencing a mifepristone emergency contraception failure,
* presenting an intrauterine singleton pregnancy confirmed by pelvic ultrasound scan, with a crown-rump length compatible within 56 days of gestation at the enrolled day, and
* seeking a medical abortion for unwanted pregnancy.
* Women who had a threatened abortion or a failure pregnancy were also included.
* Participants were required to sign an informed consent form before enrolment, willing to comply with the schedule of follow-up visits and willing to undergo surgical aspiration if indicated.

Exclusion Criteria:

* The exclusion criteria included suspected or proven ectopic pregnancy,
* allergy or contraindications for mifepristone (chronic systemic corticosteroid therapy, adrenal insufficiency) or misoprostol (hypertension, mitral stenosis, severe asthma, glaucoma, sickle cell anemia and hypotension),
* history or evidence of thromboembolism, cardiovascular disease or liver disease, hemoglobin ≤ 90 g/l, heavy smoking (more than 10 per day),
* presence of an intrauterine device, and breastfeeding.
* Other exclusion criteria included participants who had EC failure because incorrect use, for example, having further unprotected intercourse after EC.
Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)

Deep vein thrombosis (DVT) is a vascular disease characterized by the formation of a thrombus within the venous system, mainly the lower limbs. The clot structure directly influences both its location, but also its progressive profile expansion material or regression and embolic migration.

Few data are available regarding the evolution of structural properties of thrombus after an acute episode of DVT. Thrombus formation is due to the polymerization of fibrinogen into fibrin. Fibrin is a viscoelastic polymer. Its mechanical properties directly determine how the thrombus responds to forces which it is subjected.

Determining the mechanical properties of the thrombus in vivo and ex vivo is expected to study its evolutionary properties.

The main objective of the study is to characterize the in vivo properties of elastographic thrombus in patients with proximal deep vein thrombosis (DVT), for quantitative elastography performed at D0, D7, D30.

The ability to analyze the structural properties of the thrombus should allow us to then correlate these properties to the evolving nature of the thrombus (embolic migration or not, recanalization or not), and the effect of different treatment on the evolution of the thrombus

Eligibility Criteria:
Inclusion Criteria:

* Patient with proximal DVT, provoked or not, the symptomatology is less than 3d, with or without pulmonary embolism treated with heparin or oral anticoagulant
* Signed informed consent
* Patient affiliated to a social security scheme,

Exclusion Criteria:

* pregnant or lactating
* Life expectancy \<1 month
* Patient with distal DVT or asymptomatic DVT accidental discovery
* Patient who underwent venous unclogging in acute phase
* exclusion period in another study,
* under administrative or judicial oversight, under guardianship
Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine responsiveness in advance before the appearance of the drug effect until 4-6 weeks after administration of Mirtazapine.

The purpose of this study is

1. to determine whether genomic differences between drug responders and nonresponders predict the response of Mirtazapine and
2. to construct the prediction model for Mirtazapine treatment in depressed patients in order to aid to select the genetically matching drug.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.