cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus

For the patients with early gastric cancer (T1), preoperative evaluation (gastroscope, ultrasound gastroscope and abdominal enhanced CT) showed that the tumor was located in the body of the stomach, and the margin was enough to retain the pylorus and non lymph node metastasis (N0). Lappg (D1 + lymph node dissection) and traditional laparoscopic distal gastrectomy (BII type anastomosis, D1 + lymph node dissection) were included A control study was conducted to evaluate the influence of two surgical methods on the long-term quality of life of patients after operation


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old \< age \< 75 years old;
2. primary gastric lesions were diagnosed as gastric adenocarcinoma by biopsy;
3. the preoperative clinical stage was T1N0M0 according to ajcc-7thtnm;
4. it is predicted that R0 can be obtained by pylorogastric gastrectomy and D1 + lymph node dissection;
5. preoperative ECoG physical state score 0 / 1;
6. preoperative ASA score I-III;
7. informed consent of patients.

Exclusion Criteria:

1. pregnant or lactating women; suffering from serious mental illness;
2. the history of upper abdominal surgery (except laparoscopic cholecystectomy);
3. history of gastric surgery (including ESD / EMR for gastric cancer);
4. preoperative imaging examination showed regional enlarged lymph nodes;
5. having other malignant diseases within 5 years;
6. patients with gastric cancer who have received new adjuvant therapy or recommended new adjuvant therapy;
7. there was a history of unstable angina or myocardial infarction within 6 months;
8. have a history of cerebral infarction or cerebral hemorrhage within 6 months;
9. there was a history of continuous systemic corticosteroid therapy within 1 month;
10. simultaneous surgical treatment of other diseases is needed;
11. gastric cancer with complications (hemorrhage, perforation, obstruction) requires emergency surgery;
12. FEV1 of pulmonary function examination was less than 50% of the predicted value.
Intralesional Bevacizumab Injection on Primary Pterygium

The purpose of this study is to evaluate that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms.

To evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment

Eligibility Criteria:
Inclusion Criteria:

* primary pterygium

Exclusion Criteria:

* previous ocular surgery
Microcurrent Therapy and Low-Level Laser Therapy on Wound Healing

The study aiming to compare between the Microcurrent and Low-Level Laser Therapy on wound healing

The study designed to compare between the Microcurrent and Low-Level Laser Therapy on wound healing

Eligibility Criteria:
Inclusion Criteria:

* patient recently undergo appendectomy

Exclusion Criteria:

* patient with neurological disorders
* patient with metabolic disorders
Clinical Study of Smoke-Break Liquid Cigarettes

The purpose of this study is to determine whether the Smoke-Break nicotine delivery device can help smokers quit smoking, while avoiding many of the side effects associated with other smoking cessation products.

The study has been completed and published. The published study manuscript can be found here: http://www.biomedcentral.com/1471-2458/10/155

Eligibility Criteria:
Inclusion Criteria:

* Volunteer is at least 18 years of age.
* Volunteer currently smokes cigarettes, cigars or other forms of tobacco products for at least one year.
* Volunteer wants to quit smoking.
* Volunteer will be fully informed as to the nature of the study.
* Volunteer will have no known allergy to any product ingredients as listed in the informed consent.
* Volunteer agrees to a confidential pretest questionnaire and periodic monitoring as to the effectiveness of the smoking cessation regimen.
* Volunteers are not currently using another nicotine replacement therapy.
* Volunteer will agree to use birth control measures while on the study.

Exclusion Criteria:

* Volunteer has a known allergy or hypersensitivity to nicotine or other related ingredients as outlined in the informed consent.
* Volunteer does not desire to quit smoking.
* Volunteer is using another nicotine replacement therapy.
* Volunteer is pregnant or breast-feeding.
* Volunteer has a history of heart disease or advanced diabetes.
* Volunteer indicates on the application that they smoke ten (10) or fewer cigarettes per day.
* Volunteer is using a daily prescription medicine for depression or asthma.
* Volunteer is using a non-nicotine smoke cessation drug, such as Zyban or Chantix.
* Volunteer is an employee of Smoke-Break Inc., or is personally known to an employee of Smoke-Break Inc.
Lumbar Erector Spinae Plane Block in Knee Prosthesis

To determine the postoperative analgesic efficiency of ultrasound-guided lumbar erector spinae plane block, patients are divided into two groups. Study group received ultrasound-guided lumbar erector spinae plane block, where control had none. Visual analog scale and opioid consumption are recorded.

Erector spinae plane block has successfully been demonstrated to provide an efficient analgesia in patients with rib fracture, open thoracotomy, breast surgery. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of erector spinae plane block in patients with knee prosthesis. After approval, patients enrolled in the study are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, erector spinae plane block is performed to study group and no intervention to control group.

In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 1,3,6,12 and 24 hours, Patients with VAS≥4 will be given 0.03mg / kg morphine as salvage analgesia.After 30 minutes, the patients' VAS will be re-evaluated,If VAS≥4 the same dose will be repeated.

Eligibility Criteria:
Inclusion Criteria:

Over 18 years of age Planned to knee prosthesis An American Society of Anesthesiologists score of 1,2 or 3

Exclusion Criteria:

Severe cardiovascular disease Psychiatric diseases Rejected to participation Those who have chronic pain
CalFitness Smartphone-Delivered Physical Activity Intervention

The overall goal of this study is to test personalized mobile phone-based physical activity interventions among staff members at the University of California, Berkeley. Most physical fitness applications for smartphones and activity trackers use a constant goal for the number of steps each day. However, if the step goals are dynamically adjusted according to past behavior, then the corresponding goals may encourage individuals to increase their physical activity level. This study consists of a randomized controlled trial in which we are assessing the efficacy of two different algorithms for calculating personalized goals for the number of steps each day.


Eligibility Criteria:
Inclusion Criteria:

* intent to become physically active
* own an iPhone
* willing to keep the iPhone in pockets during the day
* willing to install and use the intervention app every day for 4 months
* ability to speak and read English.

Exclusion Criteria:

* known medical conditions or physical problems that require special attention in an exercise program
* planning an international trip during the next 4 months, which could interfere with daily server uploads of mobile phone data
* pregnant/gave birth during the past 6 months
* severe hearing or speech problem
* history of an eating disorder
* current substance abuse
* current participation in lifestyle modification programs or research studies that may confound study results
* history of bariatric surgery or plans for bariatric surgery in the next 12 months.
Meditation-Based Treatment for Binge Eating Disorder

The purpose of this study is to assess the relative effectiveness of a mindfulness meditation-based intervention for binge eating disorder in comparison to a psycho-educational intervention and a waiting-list control group.

As many as 30% of individuals seeking treatment for obesity meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for binge eating disorder (BED). BED is marked by recurrent episodes of bingeing, accompanied by feelings of loss of control, and involves chronic disregulation of physiological, emotional and behavioral systems. Meditation-based interventions have been used successfully to treat disorders with similar addictive and disregulatory characteristics, but have not been applied to treating BED. Data from an uncontrolled pilot study suggests that such an intervention can have marked immediate impact on decreasing episodes of binge eating and other associated characteristics in obese women. Therefore, this study incorporates appropriate comparison conditions to further investigate the efficacy of a mindfulness meditation-based intervention as a treatment component for treating BED symptoms. Exploratory aspects include further development of a manual, establishment of effect size (in comparison to appropriate comparison groups), inclusion of a more diverse population, and of measures that address: 1) individual differences in treatment response, 2) possible mechanisms, 3) time course of response, and 3) impact on medical/health variables.

Women from two communities will be randomly assigned to 3 conditions: 1) an 8-week manualized meditation-based group intervention, 2) a psychoeducational comparison condition, or 3) a waiting-list control. Primary outcome variables will be changes in binge eating behaviors, and associated measures of depression, anxiety, self-esteem, and diet; secondary variables include medical variables sensitive to dietary change (i.e., weight; blood pressure; lipid profile; blood glucose levels), and process variables related to meditation practice, such as the Tellegen Absorption Scale, perceived value and use of the meditation practice, and experiences of increased control and awareness. Participants will be evaluated pre- and post-treatment, and at 1, 3, and 6 months followup. This data would then support the further investigation of a meditation-based intervention as part of a more comprehensive treatment program for BED.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of binge eating disorder;
* BMI at least 30;
* Fluent English speaker/reader;
* Able and willing to attend 9 weekly group sessions over two months, plus followup for 6 months, either in geographic area of Terre Haute, Indiana, or Durham, North Carolina.

Exclusion Criteria:

* Psychiatric or other condition that would preclude appropriate group participation;
* On a structured diet program;
* Unstable related medical syndrome (e.g., diabetes, hypertension);
* Medication that affects weight or appetite that is still being adjusted or that is likely to change during the course of the study.
Evaluation of Symbicort® Turbuhaler® (Budesonide/Formoterol) in Chronic Obstructive Pulmonary Disease (COPD)

This non-interventional study is to analyse the therapeutic effectiveness in patients with severe COPD following a generally accepted 12-week treatment period with Symbicort Turbuhaler, which could anyhow be shortened or extended at physician's discretion.


Eligibility Criteria:
Inclusion Criteria:

* non pregnant female
* COPD with persistent symptoms in spite of regular bronchodilator therapy
* Naive or fixed combination treated patients including patients already on Symbicort Turbuhaler

Exclusion Criteria:

* Hypersensitivity to budesonide, formoterol or inhaled lactose
Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis

Nearly 60% of Amyotrophic Lateral Sclerosis (ALS) patients have a low level of diagnostic certainty (possible, probable) at the time of diagnosis. In the absence of biomarkers, this diagnosis is based, among other things, on the demonstration of the diffusion of signs of denervation by electroneuromyography (ENMG). The objective of this study is to improve the earliness and the level of diagnostic certainty by better demonstrating the diffusion of the denervation process by whole body muscular MRI.

The objective of this study is to show that the combination of ENMG and whole body muscle MRI (WB-MRI) can increase the diagnosis of definite ALS at the onset of the disease For 50 consecutive patients with suspected ALS, the present study will prospectively perform needle electromyography (EMG) and muscle analyses on whole body MRI. The diagnostic category will be determined by revised El Escorial criteria and Awaji criteria. On whole body MRI acquisition, for 83 muscles, will be explored fatty infiltration and atrophy on fat images (chronic denervation) and muscle edema on water images (acute denervation). EMG studies will be performed in at least 10 muscles (tongue, biceps brachii, first dorsalis interosseous, T10 paraspinalis, vastus lateralis, and tibialis anterior). Diagnostic classification according EMG and/ or MRI abnormalities in bulbar and the 3 spinal regions will be compared independently.

Eligibility Criteria:
Inclusion Criteria:

* Consent form signed by the patient
* Patients suspected ALS defined according Awaji Shima criteria (possible, probable, defined)
* Clinical assessment of upper motor neuron involvement
* Electrophysiologic assessment of lower motor neuron involvement

Exclusion Criteria:

* inability to give informed consent
* a contraindication to MRI
* respiratory failure impairing ability to lie flat in the scanner.
* Patient placed under judicial protection or under another protective regime,
* Females who are pregnant
Psychosocial Group Interventions for Depression

A total of 384 patients suffering from chronic depressive disorder will be randomized to receive treatment as usual, CBASP, or befriending for a period of five months. The primary outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and neurophysiological parameters. The data gathering is performed at pre- and post intervention stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the participants six months after the intervention.

The efficacy of 20-week group-CBASP as compared to TAU is evaluated by RCT in a psychiatric outpatient clinics. The recruition is completed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Moderate or severe major depression with duration of a minimum of two years OR "double depression" (dysthymia and moderate/severe major depression simultaneously) OR moderate or severe major depression with duration of a minimum of two years, only partially remitted during the time period

Exclusion Criteria:

* Psychotic disorder
* Bipolar disorder
* Current substance abuse (excluding nicotine)
Combination of Cryosurgery and NK Immunotherapy for Advanced Liver Cancer

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced liver cancer.

By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for advanced liver cancer.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers

Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. The cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research Unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.

Cold pain methodology development

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers having given consent to participate in the study who have no clinically significant anomalies and whose vital signs are within normal range.
* Subject having performed the cold pain test reproducibly ie, if the area under the pain-time curve (AUC) must be within 20% during successive tests within one cold pain test screening visit and within 30% between the two cold pain test screening visits.

Exclusion Criteria:

* Subject who have had a serious adverse reaction or significant hypersensitivity to any of the study drugs.
* Subjects with a history of or evidence of any neurological condition which could affect pain sensation.
* Subjects with an AUCcpt 0-120 sec in the cold pain test of \<1000 in any of the screening tests (excluding familiarization).
Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy

To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* are at least 18 years of age at index date
* Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period
* Had at least 1 claim with diagnosis of AF anytime in their records

Exclusion Criteria:

* Have a record that is indicative of Valvular Atrial Fibrillation during this period
* Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA)
* Have more than one OAC exposure which starts on the same date
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

This is a feasibility study without a primary study hypothesis or statistical comparison.

The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken.

Post-operative pain will be noted. Additionally, biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.

Evaluations include, but are not limited to the following:

* Deployment ease/scope compatibility.
* Device malfunctions.
* Time of catheter deployment.
* Adverse events.
* Stricture formation at 6 to 8 weeks.
* Patient Pain.
* Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual Barrett's Esophagus.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for ablation, EMR, and/or surveillance for BE (with or without dysplasia). Patient is 18 to 80 years of age at the time of consent (inclusive).
2. Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
3. Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
4. Patient is deemed operable per standard institutional criteria.

Exclusion Criteria:

1. Patient with endoscopically active inflammation in the treatment zone
2. Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
3. Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
4. Patient refuses or is unable to provide written informed consent.
5. Patients that are pregnant.
IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism

Secondary hyperparathyroidism (SHPT) is a multisystemic syndrome that affects calcium and bone homeostasis in patients with chronic kidney disease (CKD). Despite medical treatment, 1-2% of patients require parathyroidectomy anually. The use of an intraoperative paratohormone protocol (IOPTH) to predict cure still in debate, due to the lack of standardized protocols, the use of different assays and uneven PTH clearance. The aim of this study was to determine the diagnostic accuracy of an IOPTH in patients with SHPT for predicting successful surgery after parathyroidectomy.

A prospective observational study (cohort) was performed in patients who were submitted to parathyroidectomy by an endocrine surgeon for SHPT. All were submitted to a bilateral neck exploration with a subtotal parathyroidectomy. Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection. Another sample was taken 24 hours after the procedure (PTH24), values \<150pg/mL defined a successful surgery and patients were assigned to the successful or unsuccessful group. IOPTH drop was analyzed to predict successful surgery with drops of 70% and 90% at 15 and 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* PTH \>800pg/mL and SHPT symptoms, or
* Asymptomatic patients with PTH \>1000pg/mL who were resistant to treatment
* compliance with the signature of the informed consent

Exclusion Criteria:

* patients who respond adequately to medical treatment
* incomplete IOPTH protocol