cyrilzakka/clinical-trials huggingface dataset:
A Cohort of Predictive Factor of Pathologic Complete Response After Preoperative Neoadjuvant in Rectum Cancer

Due to colorectal cancer is the fourth most common malignancy in the world. Some patients had present locally advance stage and need to preoperative concurrent chemoradiation (CCRT) before radical surgery. But predictor for pathologic complete response (pCR) after preoperative CCRT remain unclear.

Objectives: To identify possible factor for predict of pCR of rectal cancer after preoperative CCRT.

After permission was obtained from our institutional review board, a cohort of patients who were diagnosed with rectal cancer and received chemoradiation between January 2011 to December 2017 at Ramathibodi hospital, Bangkok were analyzed. Patients who were not received neoadjuvant chemoradiation therapy, loss follow-up, incomplete data in the record, distant organ metastasis and who was not received colorectal surgery were excluded as study flow diagram. Age, sex, performance status, smoking, initial Hb level (g/mL), CEA level (ng/dL), distance of tumor from anal verge, diagnostic variables, clinical T staging, preoperative thickness and length from computer tomography scan (CT scan), organ metastasis before treatment, histology, treatment course, and outcomes after treatment were collected and analyzed.Total dose of radiation, interval time from CCRT to operation, and chemotherapy regimens were also collected between and after treatment. After preoperative CCRT, the radical rectal surgery was performed by eight experienced general surgeons and surgical oncologist using open and laparoscopic techniques. Perioperative data were collected and histology was evaluated by an experienced pathologists. For pathological classification, pathological responses were divided in 2 groups i.e., pathologic complete response (pCR group) and non-pCR group, (partial response, stable disease, and disease progression). Margin of lesions were classified as proximal, distal and circumferential margins. Lymph nodes status after surgery were specified as total lymph nodes harvested and positive lymph nodes.

Eligibility Criteria:
Inclusion Criteria:

* rectal cancer and received preoperative chemoradiation

Exclusion Criteria:

* distant organ metastasis
* previous colorectal surgery
Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia

To observe and compare the short-term and long-term effects of different biliary and intestinal reconstruction methods for the treatment of congenital cystic dilatation of bile duct .

The purpose of the study： length of operation time, postoperative intestinal function recovery time as the main index, application prospective clinical study to observe the differences were followed by two different laparoscopic biliary intestinal kiss the short-term and long-term effect of the treatment of congenital cystic dilatation of the bile duct, provide a higher level of evidence based medicine dilatation of patients for congenital bile duct cysts. The choice of second is based on the study, effective, objective evaluation of different laparoscopic biliary enteric reconstruction for the treatment of congenital cystic dilatation of the bile duct is feasible, clear surgical indications, contraindications and summarized the technical points, establish guidelines for clinical diagnosis and treatment of congenital cystic dilation of the bile duct disease.

Eligibility Criteria:
Inclusion Criteria:

1. gender, age 5-70 years old (the disease can occur at any age, but in 80% cases of childhood onset, such as children's height and weight of endoscopic treatment for the standard, by parents as guardians into the group);
2. preoperative congenital cystic dilatation of the bile duct (I, II, IV) clear diagnosis; preoperative assessment of liver function
3. : Child-Pugh = B;
4. bile duct without canceration;
5. recurrent cholangitis, biliary calculi in the biliary tract infection was controlled in acute pancreatitis; control of inflammation;
6. the treatment of choledochal cyst, without any surgical treatment;
7. the general condition of the patient, heart and lung function can tolerate surgery, no absolute contraindication abdominal laparoscopic operation;
8. voluntarily participated in the study, informed consent.

Exclusion Criteria:

1. congenital cystic dilatation of the bile duct of III type, V type (III type feasible endoscope end of bile duct duodenal sphincterotomy, V type partial resection of the liver);
2. patients who cannot tolerate pneumoperitoneum or serious abdominal adhesions, unable to carry out laparoscopic surgery;
3. bad general condition or heart pulmonary dysfunction cannot tolerate surgery;
4. severe cholestatic cirrhosis, severe portal hypertension;
5. high risk patients with general anesthesia.
A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC
* No prior systemic treatment for metastatic NSCLC
* High tumor tissue PD-L1 expression
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
* Adequate hematologic and end-organ function
* For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.

Exclusion Criteria:

* Known mutation in the EGFR gene or an ALK fusion oncogene
* Symptomatic, untreated, or actively progressing central nervous system metastases
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
* Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
* Severe infection within 4 weeks prior to initiation of study treatment
* Positive test result for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.
Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing

This pilot study will evaluate the impact and overall experience of an interprofessional chronic low back pain patient care approach for people in rural and remote areas using Telehealth technology compared to secure laptop based videoconferencing (Vidyo).

People with chronic low back pain will be recruited to participate in a team assessment with a local rural nurse practitioner and an-urban based physiotherapist linking through telehealth. The assessment will include a detailed history, physical examination and jointly-delivered education and recommendations for further community-based management. Pre and post measures of self-reported pain, back-specific function, quality of life, and satisfaction will be completed 2-4 weeks after the assessment. Comparison of short-term outcomes will be made with a group of participants from another study using the a different telehealth technology (secure laptop based videoconferencing) same inclusion criteria, measures and health care providers (Clin Trials.gov NCT02225535). The health care providers will be interviewed to get feedback on their preference and experience using the different type of telehealth technology.

Eligibility Criteria:
Inclusion Criteria:

chronic low back pain localized below costal margins and above gluteal folds and/or related leg pain, which is bad enough to limit their usual activities or daily routine and has been present for at least 3 months

Exclusion Criteria:

* People with: third party payer insurance (i.e.worker's compensation board) for their back related complaints, with primarily neck or thoracic pain, and/ or with language, reading or comprehension barriers that would limit their ability to adequately complete the required study paperwork will be excluded from participating in the study.
Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction

Recent studies have found that pelvic floor muscle training can relieve pelvic organ prolapse related symptoms. However, the rate of cure or improvement of symptoms with exercise prescription, different compliance of the patient's behavior have great differences. Biofeedback is an instrument used to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and provide feedback in auditory or visual form (a louder sound with a stronger squeeze or an increasing number of lights on a visual display as the strength of the squeeze increased). Therefore, this study would explore the efficacy of biofeedback-assisted pelvic floor muscle training in women with pelvic floor dysfunction with or without organ prolapse.

Treatment options for pelvic floor dysfunction (PFD) vary depending on symptom severity. Conservative approaches such as pelvic floor muscle (PFM) exercises, biofeedback, and lifestyle advice are usually suggested for urgency incontinence (UI), overactive bladder (OAB), and mild-to-moderate pelvic organ prolapse (POP). Conservative management remains the gold standard of treatment for female UI and OAB. There is Level 1, Grade A evidence supporting pelvic floor muscle training (PFMT) as an effective treatment for UI and OAB, and Grade B evidence that pelvic floor muscle training (PFMT) reduces the symptoms of urogenital prolapse, although topographic changes are not expected. Most of the past literatures focused on the effectiveness of PFMT on single disease, but seldom explored its effectiveness on complex disease (i.e. women presenting with more than one type of PFD). In the real world, some degree of POP was present in 41% to 50% of women on physical examination, but only 3% of patients reported symptoms such as bearing down sensation of vagina. Besides, there was a number of studies that assessed the efficacy of PFMT as a treatment for women with POP, but rarely explored its effectiveness in both subjective and objective (anatomic) improvement of prolapse severity.

Biofeedback provides positive reinforcement to patients performing PFMT, therefore improves the quality of life of women with PFD. It can be achieved via several methods, including electromyography (EMG), manometry, or ultrasonography. A systematic review confirmed the benefit of adding of biofeedback to PFMT, but it was not clear whether this was the effect was related to another variable, such as the amount of health professional contact rather than the biofeedback.

Eligibility Criteria:
Inclusion Criteria:

1. pelvic organ prolapse for more than 3 months
2. more then 20 year old,less then 85 year old and acceptable to receive vaginal examination
3. need to match schedule with the investigator's clinic for 5 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 12 weeks of pelvic floor muscle exercises

Exclusion Criteria:

1. women who were unable to contract their PFMs due to cognitive deficit
2. had a neurological disorder
3. pregnant
Pulse Corticosteroid Therapy and Effect on Brain Water Diffusivity

In daily clinical use, pulse high dosis corticosteroids are used to treat cerebral edema in different pathological situations ( surgery, trauma, tumors...). Dehydration can theorically concern extra-cellular or intracellular water, or both.

The relative proportion of those two components are not known, as well their kinetics.

Diffusion Weighted Imaging ( DWI) is a none invasive and none toxic technique to study those phenomena.We can also study the diffusivity anisotropy not using a Gaussian distribution but rather a non- gaussian one, more close to the reality ( q Space Imaging ).

Finally, we can study the compartment redistribution between slow and rapid water molecules diffusion by bi-exponential decomposition of the diffusion signal, corresponding, theorically, respectively to the intra- and extra-cellular component.

Hypothesis : The high dosis steroid pulse therapy modifies or not the water free diffusion in DWI and qSI ? Is there a modification in the diffusivity of both rapid and slow component ?


Eligibility Criteria:
Inclusion Criteria:

* Systemic Lupus Erythematosus
* normal neurological exam
* informed consent
* 18 yo or more

Exclusion Criteria:

* abnormal neurological exam
* younger than 18 years old
Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis

Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Relapsing Remitting Multiple Sclerosis (RRMS), and treated with Betaferon, with the decision for treatment made at the discretion of the attending physician, documented with a prescription of Betaferon by the physician
* EDSS 0 - 6
* Written informed consent

Exclusion Criteria:

* Patients who do not meet the local indication criteria for Betaferon treatment.
* Contraindications listed in the local SmPCs have to be considered.
* Patients with a history of severe head trauma.
* Patients with alcohol and/or drug abuse.
* Patients with mental retardation.
* Patients with learning disability.
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities

The purpose of this study is to:

1. Development of culturally sensitive videos for enhance informed consent with neurostimulation and determination of factors that influence minority interest in participating in neurostimulation research.
2. Examination of the influence that video enhanced informed consent has on expectations with transcutaneous auricular vagus nerve stimulation (taVNS) and on treatment intended effects.


Eligibility Criteria:
Inclusion Criteria:

1. between the ages of 18-80 years
2. neuropathic pain lasting longer than 3 months (i.e., complaint of sensation of burning, stabbing or pressing pain, shooting or shock like pain, or paresthesias)
3. Neuropathic Pain Symptom Inventory score ≥10.
4. self identifies as Black or Hispanic

Exclusion Criteria:

1. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
2. pregnancy
3. currently taking Buprenorphine or recently stopped taking (within 1 month)
4. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
5. implants in the head or neck, cochlear implants, or pacemaker
6. head or neck metastasis or recent ear trauma
7. history of seizures.
Effects of Whole Body Vibration in People With Chronic Stroke

The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone health, physical fitness and neuromotor performance in patients with chronic stroke.

Subjects in the experimental group will undergo whole body vibration therapy (1 session per day, 3 sessions per week) for 8 weeks. The vibration frequency used in this study will be 30Hz. The total duration of exposure to vibration for the experimental group will be 10 minutes. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The control exercise group, on the other hand, will perform the same exercise program on the platform, but no vibration will be given. The training will be conducted by a qualified personnel with physiotherapy background.

The outcome measurement will be performed 4 times: (1) immediately before the commencement of intervention, (2) immediately after termination of treatment, (3) at 1 month after termination of treatment. Each subject will be evaluated for bone markers, leg muscle strength, balance, spasticity, and walking ability.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of stroke more than 6 months
* medically stable
* able to understand verbal commands
* Abbreviated mental test score 6 or above
* age \>18
* able to stand with or without aids for at least 1.5 minutes

Exclusion Criteria:

* neurological conditions other than stroke
* significant musculoskeletal conditions (e.g. amputations)
* metal implants in the lower extremity
* previous fracture of the lower extremity
* are currently taking bone resorption inhibitors or were taking the same before stroke.
* significant peripheral vascular disease
* vestibular disorders
* pregnancy
* Other serious illnesses that preclude the person from participating in the study
Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes

Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face this health problem. The goal of this trial is to evaluate the effect of empagliflozin + linagliptin + metformin + lifestyle on physiopathological parameters, sush as glucose metabolism, insulin resistance, pancreatic beta cell function and cardiovascular function in patients with impaired fasting glucose plus impaired glucose tolerance, during 12 months

The main goal of this clinical trial is to compare the effect of two different treatments during 12 months:

1. Lifestyle modification program + metformin 850 mg twice daily
2. Lifestyle modification program empagliflozin (12.5 mg) + metformin (850 mg) once daily plus linagliptin (2.5 mg) + metformin (850 mg) once daily On the following parameters, after 12 months of treatment

1) Glucose metabolism, evaluated by oral glucose tolerance test 2) Insulin resistance evaluated by the oral glucose tolerance 3) Insulin secretion, evaluated by the oral glucose tolerance 4) Pancreatic beta cell function, evaluated by the oral glucose tolerance test 5) Cardiovascular function, evaluated by standard echocardiography by left ventricular ejection fraction

All the patients will have a basal evaluation with an oral glucose tolerance test, lipid profile and body composition measurement by dual energy X-ray absorptiometry (DEXA). After the basal evaluation, if the patients results with impaired fasting glucose and impaired glucose tolerance, they will be invited to the intervention phase where they will be randomized to one of the two treatment groups.

Patients will have a follow-up visit every month to review the adherence to the lifestyle modification program and to the medication, and every 6 months an OGTT. After 12 months , patients will repeat the same evaluation performed at basal.

Eligibility Criteria:
Inclusion Criteria:

* Patients with prediabetes, defined for the existence impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2 hours of the Oral Tolerance Glucose Test (OGTT) with impaired fasting glucose (fasting glucose between 100 and 125 mg/dL)
* Patients who accept to participate in the study and sign the informed consent letter.

Exclusion Criteria:

* Patients with diagnosed Type 2 Diabetes previously or detected during the OGTT
* Patients in actual treatment or during the last 3 months with metformin, pioglitazone or another antidiabetic drug, including insulin
* Serum creatinine \> 1.6 mg/dL
* Hypertriglyceridemia very high (\>500 mg/dL)
* Pregnant women
* Altered arterial hypertension (Systolic \>180 mmHg or Diastolic \>105 mmHg)
* Excessive alcohol intake, acute or chronic
* Medications or medical conditions that affect glucose homeostasis (thiazides, beta blockers, glucocorticoids for systemic use, weight-reducing drugs or anorexigenics, Cushing´s syndrome, thyrotoxicosis
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study

The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Medical history and symptoms of knee osteoarthritis

Exclusion Criteria:

* Any other disease or medication affecting the bone or cartilage.
* Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.
Dilution of Verapamil During Intraarterial Administration

This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups:

1. Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
2. Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL)

The investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms.


Eligibility Criteria:
Inclusion Criteria

* English Speaking patients who are age 18 or older
* Patient must be able to provide own consent and communicate with staff
* Patient's undergoing transradial access (TRA) for the left heart catheterization (LHC)

Exclusion Criteria

* Intubated or sedated patients
* Agitated patients requiring moderate sedation prior to TRA
* Patient's undergoing femoral access for the LHC
* Non-English speaking patients
* Contraindications to Verapamil or Nicardipine: including allergies to these medications, hypotension (mean arterial pressure \<65), Bradycardia (heart rate\<40)
* Emergent cardiac catheterization
* Inability to obtain radial artery access
* Conversion to radial artery access from another access site