cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) HCC

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related mortality and the sixth most prevalent cancer in the world. Standard treatments for early-stage HCCs include resection, liver transplantation, and percutaneous ablation, with 5-year survival rates of over 50 percent. Less than one-third of patients, however, are candidates for hepatic resection, and the use of radiofrequency ablation (RFA) may be significantly limited in cases with unfavorable tumor location and poor visibility on images, which increase the risk of technical failures and complications after RFA.

Recent advancements in radiotherapy and imaging have made it possible to deliver optimal radiation doses on the tumor site while minimizing exposure to normal organs. Stereotactic body radiation therapy (SBRT) is a method of high-precision radiation therapy that concentrates high-dose radiation to HCC in a short period of time to maximize the therapeutic effect on the tumor and minimize the side effects on normal tissues. Prospective and retrospective studies on SBRT for HCC have demonstrated its efficacy for local tumor control in small HCC. On the basis of these promising clinical results, a number of studies have compared the efficacy of RFA and SBRT. However, there is no strong evidence from randomized controlled trials comparing SBRT and RFA.

In order to evaluate and compare the local efficacy and clinical outcomes of SBRT and RFA in patients with recurrent HCC, we conduct this non-inferiority trial.

A total of 178 subjects are randomly assigned to one of two treatment groups (89 patients in the body stereotactic radiotherapy group and 89 patients in the radiofrequency ablation group). If the assigned treatment method is technically infeasible, patients are allowed to be treated with the other method.

* RFA: When localization of the lesion is difficult under image guidance, when it is difficult to secure a safe needle path, when there is a risk of collateral thermal damage to adjacent organs, and when it is difficult to prevent it.
* SBRT: When irradiation with 45 Gy (daily dose of 15 Gy) is infeasible due to the maximum tolerance dose of normal organs.

Eligibility Criteria:
Inclusion Criteria:

1. patient over the age of 18
2. primary or recurrent HCC that is not suitable for surgery
3. HCCs with a longest diameter of ≤3cm and ≤2 lesions
4. no evidence of intrahepatic or extrahepatic residual disease except for target lesions
5. Child-Pugh class A or B hepatic function
6. no macroscopic vascular invasion or extrahepatic metastasis
7. written informed consent

Exclusion Criteria:

1. Eastern Cooperative Oncology Group performance status score 3 or 4
2. uncontrolled ascites, variceal bleeding, or hepatic encephalopathy
3. previous history of liver transplantation
4. an active gastric or duodenal ulcer within 3 months before screening
5. pregnant woman
6. uncontrolled other malignancies except for HCC within 2 years before screening
7. platelet count \<50,000/µl
8. Patients who are judged by the researcher to be difficult to conduct clinical research
Effects of Active Release Technique and Instrument Assisted Soft Tissue Mobilization in Patients With Migraine

Rationale of this research is to evaluate the outcome of active release technique and Instrument assisted soft tissue mobilization on trigger points in subjects with Migraine. The significance of this study is to identify which technique is superior in alleviating the symptoms of migraine. This study will help gather evidence on the practice of incorporating trigger point therapy in the treatment of Migraine.

Migraine is a neurological condition that typically causes painful headache attacks lasting from four to 72 hours that occur with additional symptoms, such as sensitivity to light, sound, smell, or touch. Migraines occur most frequently in the morning, especially upon waking. Migraines can be triggered by stress or hormones. Migraine attacks are debilitating and can hinder the day to day activities and productivity of the patient. The purpose of the study was to evaluate the effects of active release technique and instrument assisted soft tissue mobilization on trigger points. It was a randomized, controlled trial, conducted among migraine patients. Sample size was 54 by using Epitool software. Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope.All participants in both groups were evaluated on baseline and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

Both male and female 18-30 years Trigger points in Trapezius , Sternocleidomastoid and Sub-occipitals (Identified using Travel and Simmons Criteria) Migraine without Aura Subjects were cognitively capable and competent to follow the instructions

Exclusion Criteria:

Dysfunctions in the temporomandibular joint. Participant with a history of basilar migraine or hemiplegic migraine Fracture of Cervical Spine Currently on Medication for Migraine
Effect of Retro-walking on Postpartum Low Back Pain

This study will be conducted to determine the effect of retro walking on post partum low back pain.

Postpartum LBP is a common musculoskeletal disorder. It occurs due to ligament laxity and postural changes that started during pregnancy or within 3 weeks of childbirth and continue for 3 months after delivery. When all forms of non-specific LBP were considered, approximately 33% of postpartum women had some LBP within 3 months after childbirth, and approximately 40% described moderate to severe disability.

Postpartum LBP stresses the sacroiliac joints and lumbosacral spine. Previous studies of Swedish women with postpartum LBP reported impairments to their daily activities with a prevalence ranging between 20-90%, but they seldom sought health care assistance or treatment.

Many researchers and clinicians have suggested that an increase in core strength and improvement in pelvic alignment are keys to resolve or avoid LBP. During backward walking, the typical heel-strike associated with ground contact is eliminated because the toe contacts the ground first and the pelvis is anteriorly aligned. This may open up the facet joints in the vertebral column and help in alleviating the pressure on intervertebral discs and the associated LBP.

Previous studies investigated the effect of retro walking on other types of LBP (non-specific and chronic) but till now, there is no previous study investigate the effect of retro walking on postpartum LBP related to C.S delivery. So, this study will be the first one in this issue. Therefore, this study will be of valuable benefits for medical service organization and increase the body of knowledge in physical therapy field.

Eligibility Criteria:
Inclusion Criteria:

* Multi parous women suffering from postpartum low back pain after cesarean delivery (from 6 weeks to 6 months after delivery).
* Their ages will range from 25-35 years old.
* Their body mass index will be less than 30 Kg/m2.
* They should have mild to moderate low back pain as scored on VAS (represented by cut points on the scale recommending mild pain (5- 44mm), moderate pain (45- 74mm))

Exclusion Criteria:

* Recent surgeries, trauma or fractures of the lower limb or in the back region.
* Morbid cardiovascular disease.
* Liver or kidney dysfunction.
* Any neurological disorders including balance issues or motor and sensory loss.
* Any musculoskeletal disorders such as disc prolapsed, lumbar canal stenosis and spondylysthesis or severe knee osteoarthritis.
* Taking intra-articular injection for knee for the last 6 months.
* Those having visual dysfunction or refractory errors not corrected with glasses or contact lenses.
Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology

Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients. Current procedures available demand difficult invasive procedures and hence these parameters are not measured with enough frequency and are also limited to certain patients. The new COstatus system is capable of using the already existing arterial and venous lines placed in critically ill patients and thus provides an opportunity to measure these parameters less invasively and with enough frequency.

The purpose of this study is to measure cardiac output and blood volumes using ultrasound dilution technology (COstatus system)in post cardiac surgery adult patients and compare the cardiac output measurements with a current clinical reference method, thermodilution.


Eligibility Criteria:
Inclusion Criteria:

* Post cardiac surgery adult patients
* Patients with heart catheter and arterial catheter

Exclusion Criteria:
9 Minutes for Tandem Colonoscopy Withdrawal

A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose age is between 40-75.
* Patients who have indications for screening
* Patients who have signed inform consent form.

Exclusion Criteria:

* Patients who have undergone colonic resection or polypectomy
* Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
* Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days
* Patients with inflammatory bowel diseases
* Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests
* Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
* Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
* Patients with failed cecal intubation
* Patients with poor BPQ that necessitated a second bowel preparation
* Patients with therapeutic colonoscopy for existing lesions
* Patients refusing to participate or to provide informed consent
Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia


Eligibility Criteria:
Inclusion Criteria:

1. Adults patients, between 18 and 55 years of age
2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year
3. The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:

   * Aripiprazole
   * Aripiprazole long-acting injectables:

     * Abilify Maintena®
     * Aristada®
   * Risperidone
   * Risperidone long-acting injection
   * Olanzapine
   * Lurasidone
   * Cariprazine
   * Brexpiprazole
   * Asenapine
4. Has had a partial but inadequate response to antipsychotic treatment
5. Has a history of response to antipsychotic treatment other than clozapine

Exclusion Criteria:

1. Patient has a psychiatric disorder other than schizophrenia
2. Patient has a history of resistance to antipsychotic treatment
3. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

   a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
4. Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
5. Patient has had a myocardial infarction in the last six months
6. Patient is taking a medication or drug that prolongs the QT interval or has a family or personal history or symptoms of long QT syndrome

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
The Quality Of Life Of Cerebral Palsy Child Carers

Cerebral Palsy (CP) is characterized by a sensory-motor deficiency, involving disturbance of muscle tone, posture and voluntary movement. Children who are afflicted need special intense care for their carers

INTRODUCTION: Cerebral Palsy (CP) is characterized by a sensory-motor deficiency, involving disturbance of muscle tone, posture and voluntary movement. Children who are afflicted need special intense care for their carers. OBJECTIVE: The objective of this study was to analyze the quality of life of CP child carers attended in the physiotherapy sector of a philanthropic institution on Maceió - AL. METHODS: 62 carers were assessed in the period from the 18th to the 29th of February 2008, in which 96.7% were female carers and 3.7% male. The form for the collection of data from the carers, elaborated by the researchers and the WHOQOL-26 quality of life questionnaire were utilized as as instruments.

Eligibility Criteria:
Inclusion Criteria:

* Children who were attended by Associação dos Pais e Amigos dos Excepcionais (APAE), Maceió, Alagoas
* They had cerebral palsy

Exclusion Criteria:

* Child who had not cerebral palsy
* Child under 2 years old
Levobupivacaine for Epidural Analgesia in Labour

In a prospective randomised study involving primiparous women in spontaneous uncomplicated labour with cervical dilatation \> 7 cm, epidural analgesia will be given with an initial volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual injections to achieve analgesia, then by a patient-controlled regimen with 5-mL self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic solution will be levobupivacaine presented in 100-mL bags from the market, 0.0625%, or 0.125%, in which 10 mL (50 µg) of sufentanil will be added. The final concentrations will be 0.568 and 1.136 mg.mL-1 respectively, both with sufentanil 0.45 µg.mL-1. Parturients and midwifes assessing pain during labour will be blinded to the design

Since epidural analgesia has been developed to relieve labour pain, many solutions have emerged to lower risk / efficacy ratio, by using low-concentrated and/or less toxic local anaesthetics. Levobupicaine emerges as a safer alternative than its racemic parent . It is available on the French market in pre-filled bags with two different concentrations (0.625 and 1.25 mg.mL-1), both indicated for analgesia in postoperative context and in labour, without more precision. Presentation in bags allows preparing once at the initiation of epidural analgesia a solution usable throughout labour, leading the anaesthetist to a univocal choice, mostly following his/her personal beliefs. Our aim is to compare the effects of epidural analgesia under these two presentations. Sufentanil will be added to levobupicaine whatever the concentration used. This trial is conducted in primiparous, in which pain during labour is commonly more resistant to relief.

Eligibility Criteria:
Inclusion Criteria:

* Parturient \> 18 years old
* ASA physical status 1 or 2
* Primiparity
* Singleton
* Gestational age \> 36 weeks
* Spontaneous labour with cervical dilatation \> 7 cm

Exclusion Criteria:

* Gestational age \< 36 weeks
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors

The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L

At present, clinical efficacy and safety data is available for iron isomaltoside 1000 administered to patients with IDA requiring iron therapy. However, there is a need for clinical efficacy and safety data within iron deficiency without anaemia which is e.g. observed in blood donors. Thus, this study is planned to compare the efficacy and safety of parenteral iron isomaltoside 1000 with placebo in female blood donors with a p-ferritin below 30 µg/L.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥ 18 years
2. First-time donor
3. P-ferritin \< 30 µg/L
4. Willingness to participate and signed the informed consent form

Exclusion Criteria:

1. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
2. Known hypersensitivity to any excipients in the investigational drug products
3. History of drug related allergies
4. History of severe asthma
5. Decompensated liver cirrhosis and hepatitis (defined as ALAT \> 3 times upper limit of normal)
6. Active acute or chronic infections (assessed by clinical judgement supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP))
7. Rheumatoid arthritis with symptoms or signs of active inflammation
8. Subjects who are pregnant or nursing. In order to avoid pregnancy, women have to be postmenopausal (at least 12 months since last menstruation), surgically sterile, or use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, vaginal devices, or hormonal injections with prolonged release)
9. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening
10. Untreated vitamin B12 or folate deficiency
11. Treated with other IV or oral iron products within 4 weeks prior to the screening
12. Treated with Erythropoietin (EPO) within 4 weeks prior to the screening
13. Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study
Neural Tensioner Exercise on Conditioned Pain Modulation

Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain there is no activation of CPM.

Objectives: The purpose of this study is to measure the CPM response and determine whether neural tensioner exercise in patients with chronic neck pain is effective in the improvement of neck pain intensity, neck disability and cervical range of motion.

Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the sham technique (ST) group.

Individuals will be included in the study if they meet the following inclusion criteria: aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head. Neck pain intensity with a visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion will be measured pre and port intervention.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years.
* neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head, trunk, and/or the upper limbs.
* the ability to understand, write, and speak Spanish fluently

Exclusion Criteria:

* development of systemic or degenerative diseases;
* symptoms of depression according to Beck's questionnaire.
* pain in any area between the lower back and the head in the last 9 months.
* neck pain associated with whiplash injuries.
* medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis). - neck pain with cervical radiculopathy.
* neck pain associated with externalized cervical disc herniation.
* fibromyalgia syndrome.
* previous neck surgery.
* neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches due to a traumatic event in the past 12 months.
* and history of neck or face pain in the last 6 months.
Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol Compared With That With Partially Tubeless Protocol

Previous studies have shown the feasibility of ERAS on minimally invasive lung surgery, but it is unknown whether completely tubeless protocol is safe and better. This study aimed to determine whether completely tubeless protocol is feasible and beneficial for minimally invasive lung surgery, compared with partially tubeless protocol.


Eligibility Criteria:
Inclusion Criteria:

(I) Wedge resection or sub-lobar resection or lobectomy is considered as the primary surgical strategy. The operation ideally should not exceed 2 hours; (II) No absolute age limit; (III) Patients with Eastern Cooperative Oncology Group (ECOG) physical performance score of ≤2 points; (IV) P a t i e n t s w i t h a n A m e r i c a n S o c i e t y o f Anesthesiologists Standard (ASA) grade of ≤ III; (V) Body mass index (BMI) \<30 kg/m2; (VI) Patients with no clinically significant cardiac history, such as ischaemic heart disease, valvular heart disease, rhythm disturbances such as frequent atrial fibrillation or premature ventricular contractions (PVCs). Patients with significant cardiac history should be optimized according the relevant guidelines before surgery is considered; (VII) Normal cardiopulmonary function \[predicted forced expiratory volume in the first second (FEV1%) \>50% and ejection fraction (EF) \>50% of predicted value\]. Resting blood gas analysis showing arterial partial pressure of oxygen (PaO2)≥75 mmHg and arterial partial pressure of carbon dioxide (PaCO2) \<45 mmHg; (VIII) Normal renal function and no history of urological problems.

Exclusion Criteria:

(I) Patient-related factors: (i) Patients who refuse surgery and/or the anesthesia protocols; (ii) Coagulopathy, hypoxemia (PaO2 \<60 mmHg), hypercapnia \[arterial carbon dioxide tension (PaCO2) \>50 mmHg\], or elevated risk of regurgitation (\<6 hours of fasting) preoperatively or combined with gastroesophageal reflux disease; neurological disorders; (iii) Severe acute pulmonary infection or tuberculosis; (iv) Relative contraindications: upper airway secretions or persistent cough, spinal deformity, or brain edema (if thoracic epidural anesthesia is to be used); (v) History of ipsilateral surgery and other conditions which can result in extensive pleural adhesion; (vi) Phrenic nerve paralysis on the non-operated side should be viewed as a contraindication to VATS; (vii) History of urological conditions increasing the need for urinary catheterization; (viii) Significant cardiac history. (II) Anesthesia-related factors: (i) Allergy to local anesthesia; (ii) Any contraindication to the regional anesthesia.