cyrilzakka/clinical-trials huggingface dataset:
A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy

This study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy.

This study is designed to primarily examine how pregabalin affects the autonomic nerve or sympathetic-parasympathetic regulation in patients with diabetic neuropathy and its relationship to neuropathic pain. The goals of this study include (1) assessing the change of parameters of autonomic nerve function such as heart rate variability (HRV), respiratory sinus arrhythmia (RSA), minute ventilation, and changes in objective sleep parameters measured by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo; (2) assessing the symptom change of neuropathic pain upon treatment of pregabalin in comparison to placebo; (3) assessing the change of anxiety symptoms upon treatment of pregabalin in comparison to placebo; (4) assessing the change of depressive symptoms upon treatment of pregabalin in comparison to placebo; (5) assessing the relationship of autonomic nerve function with neuropathic pain at baseline prior to treatment and the correspondences to the study drug; (6) assessing the relationship of autonomic nerve function with anxiety and depressive symptoms at baseline prior to treatment and their correspondences to the study drug; (7) identifying sensitive and reliable parameters of autonomic nerve regulation as predictor(s) of the severity and improvement of neuropathic pain and/or anxiety; and (8) to assess the change in objective sleep parameters (EEG/EOG) by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo

Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged 18 years or older
* Meet criteria for diagnosis of diabetic neuropathy
* Average daily pain scores greater than or equal to 4 by Visual Analog Scale
* Ability to give informed consent
* No pregnancy

Exclusion Criteria:

* Patients with clinically significant psychiatric disorders requiring vigorous interventions, i.e., moderate to severe depressive disorder, psychotic disorders, PTSD, obsessive compulsive disorder, panic disorder, substance abuse, or personality disorders, or active suicidal/homicidal ideations, or past history of active suicidal ideation and/or attempts
* Patients on gabapentin which cannot be discontinued, meaning a dose greater than 1200mg. If a patient is on a dose of gabapentin that is less than 1200mg and he or she is willing to stop taking the medication, he or she can participate in the study. These patients must take the last dose of gabapentin the night before starting the study.
* Patients being non-compliant with diabetic control
* Inability to wear the LifeShirt
* Unable to participate or answer questions using a personal digital assistant input device
Close Obstructive Sleep Apnea (OSA) Trial

The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals diagnosed with severe OSA, defined as an apnea-hypopnea index (AHI) greater than 30, associated with nocturnal saturation below 90%, as determined by a sleep medicine specialist using polysomnography.
2. Individuals need to have a patent foramen ovale documented by echocardiography.

Exclusion Criteria:

1. Individuals unable to take aspirin, clopidogrel, and/or ticagrelor.
2. Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis

This study will compare the efficacy of CellCept \[0.5-2 grams per day (g/day) orally (p.o.)\] and cyclophosphamide \[0.5-1 grams per square meter (g/m2) quarterly\] as maintenance treatment for patients with lupus nephritis. All patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free follow-up. The anticipated time on study treatment is 12 months.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* diagnosis of systemic lupus erythematosus and lupus nephritis (class III, IV or V).

Exclusion Criteria:

* patients who have received cytotoxic drugs in previous 8 weeks;
* systemic infections;
* hepatitis B or C, or HIV.
Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors

This Trial evaluated the extent of pulp survival following pulpotomy in the permanent tooth pulp exposed by caries and identify potential risk factors for pulpal complications.

Healthy patients ≥ 21 years old were recruited with informed consent. Inclusion criteria were symptomatic and asymptomatic periodontally sound teeth, positive response to pulp sensibility tests, pulp exposure by caries with bleeding, haemostasis achieved within 10 minutes and normal apical tissues. Under local anaesthesia and rubber dam isolation, caries was removed before pulpotomy. Pain complaint, clinical and radiographic data were collected during recalls for up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

Patient factors:

* Male and female at least 21 years of age
* Healthy and ambulant
* Mild diseases only and without substantive functional limitations
* Able to return for scheduled recalls

Tooth factors:

* Deep caries leading to pulp exposure
* With or without pre-operative spontaneous and/or aggravated pain
* Positive response to Cold and Electric Pulp Tests
* Positive bleeding on pulp exposure
* Haemostasis within 10 minutes
* Intact and continuous periodontal ligament space and dental lamina dura on radiograph

Exclusion Criteria:

Patient factors:

* Younger than 21 years of age
* Pregnant female
* Poorly controlled systemic diseases e.g. diabetes mellitus, hypertension

Tooth factors:

* Extensive tooth structure loss requiring post and core retained restoration
* Uncontrolled periodontal disease
* Cracked tooth
* Traumatized tooth
* Haemostasis not achieved within 10 minutes
SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice

This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe obstructive jaundice.

PRIMARY OBJECTIVES:

I. To compare the 30-day overall complication rates between patients with severe obstructive jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents (SEMS) and patients undergoing direct surgical resection.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department of Surgery per their standard of care
* Serum bilirubin \> 10 mg/dl
* Adequate birth control

Exclusion Criteria:

* Patients with evidence of distant metastasis on computed tomography (CT) or magnetic resonance imaging (MRI)
* Patients anticipated to require vascular reconstruction
* Patients with cholangitis
* Patients for whom surgery is deemed inappropriate by surgeon
* Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL
* Patients who previously underwent biliary decompression for cholangitis by ERCP or percutaneous transhepatic cholangiography (PTC)
* Patients with low performance score (Karnofsky performance status scale \< 50)
* Patients with known preexisting liver disease with associated elevated bilirubin
* Patients who are pregnant or actively breast feeding
Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer

Evidence of implementation of laparoscopic total gastrectomy (LTG) for locally advanced gastric cancer (GC) remains inadequate. This study aimed to compare short- and mid-term outcomes of LTG versus open total gastrectomy (OTG) for cT2-4a GC.

Gastric cancer (GC) is a significant public health issue worldwide. Surgical resection and lymphadenectomy is the first option for curative treatment of this disease. For tumors located in the middle and/or upper third of the stomach, open total gastrectomy (OTG) has long been the standard surgery.

While the advantage of laparoscopic distal gastrectomy over open distal gastrectomy for not only early gastric cancer (EGC) but also locally advanced gastric cancer (AGC) had been proven, the use of laparoscopic total gastrectomy (LTG) for GC, particularly for AGC, has not been widely accepted due to technical challenges with lymphadenectomy at the distal pancreas and the splenic hilum as well as the complexity of the esophago-jejunal reconstruction. Recently, there has been advancement in laparoscopic techniques and improved surgical experience, a standard procedure of LTG has been established, leading to increase utilization of LTG, especially for EGC. Two large RCTs, KLASS-03 in Korea and CLASS-02 in China, provided good evidence for the advantages of LTG for EGC. However, for AGC, some prior studies have demonstrated the safety of LTG compared to OTG but lacked significant data for survival. Until now, there have been no completed RCTs to determine the short- and long-term outcomes of LTG for AGC.

In the research center, LTG has been accepted as a standard procedure for EGC since 2008 and for AGC since 2013. In Vietnam and other low-to-middle-income countries, most GC was diagnosed in an advanced stage. It is needed to have evidence of the feasibility, safety, and oncological results of LTG for locally advanced GC. Investigators performed this study to compare the technical feasibility, short- and long-term outcomes of LTG versus OTG for stage T2-4a GC.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
* Age: 18 - 80 year old
* Tumor required total gastrectomy for radical treatment
* Preoperative cancer stage (CT scan stage): cT2-4aNanyM0
* ASA score: ≤ 3
* Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Exclusion Criteria:

* Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer
* Bulky lymph node andd/or Para-aortic lymph node metastasis
* Combined esophagectomy due to invading to the esophagus
* Pregnant patient
Post Hematopoietic Stem Cell Transplantation

This was a prospective, single-arm, multicenter, national, phase II clinical study. The purpose of this Phase II study was to examine the safety and efficacy of deferasirox to decrease iron overload (IOL) in the posttransplant period in patients with beta-thalassemia major.


Eligibility Criteria:
Inclusion Criteria

* Patients who had hematopoietic stem cell transplantation (HSCT) for beta-thalassemia major
* hematopoietic stem cell transplantation (HSCT) was performed minimum 6 months and maximum 2 years ago
* The washout period after the immunosuppressive therapy should be at least 3 months.
* Signifacant IOL should be present including:

A. Serum ferritin \>1000 μg/L or B. cardiac MRI \<20 ms or C. liver iron concentration ≥ 5 mg/g dry weight measured by R2\* MRI

Exclusion Criteria

* Patients who had any contraindication for treatment with deferasirox according to the prescribing information

  •Patients who depended on transfusion
* Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)
* Patients who were experiencing severe complication of HSCT e.g. acute Graft-versus host disease (GVHD)
* Significant proteinuria / Increase in serum creatinine
Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects

Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its metabolites including excretion and mass balance of parent compound and radioactivity; to isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine and feces


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening. Health is confirmed by medical history, physical examination, laboratory testing and 12-lead electrocardiogram (ECG)
* Signed written informed consent in accordance with Good Clinical Practice
* Age ≥ 18 and ≤ 45 years
* Subjects within 10% of the normal height: weight range defined by the Metropolitan Life Insurance Company Tables

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, and ECG) deviating from normal and of clinical relevance
* History of clinically significant disease including metabolic, endocrinologic, immunological, hepatic, renal, gastrointestinal, respiratory, cardiovascular, psychiatric or neurological
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Subjects with a history of drug abuse or alcoholism
* Chronic or relevant acute (within 1 month of screening) infections
* Subjects who have taken prescription within one month or over-the-counter drugs within two weeks of the start of the trial
* Participation in another trial with an investigational drug (≤ 2 months prior to administration or during trial)
* Inability to refrain from smoking on trial days
* Blood donation \> 400 mL (within 1 month prior to administration or during the trial)
* Any laboratory value outside 10% of the reference range of clinical relevance (but not exclusive to) total white cell count ≥ 10 x 10\*\*9/L, any hemoglobin \< 12 mg/dl or \>15 mg/dl. Protein on urine dipstick
* Positive urine drug screen, positive HIV or Hepatitis C antibodies
* History of any familial bleeding disorder
The Role of Extracellular pH on Spermatozoa's Directional Movement in Vitro

The purpose of this research project is to determine whether or not the directional movement of spermatozoa is influenced by a pH gradient by examining spermatozoa in vitro.


Eligibility Criteria:
Inclusion Criteria:

* Normal semen sample
Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)

60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type 2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio urinary excretion. Intestinal and colonic biopsies will be also provided for studying permeability. For only patients, samples from the gastric resection will be provided for analysing the enteric nervous system and motricity.


Eligibility Criteria:
Patients:

Patients must be aged between 18 and 65 years old with a BMI\>40kg/m2 for non complicated patients or with a metabolic syndrome and with a BMI\>35kg/m2 for patients with type 2 diabetes or hypertension. They must be eligible for bariatric surgery.

Patients with a type 1 diabetes, neurologic or neuro-degenerative disease will be excluded.

Volunteers:

Volunteers must be aged between 18 and 65 years old with a BMI between 20 and 25kg/m2 Men and women are eligible.
Tools for Wellbeing COVID-19 National Study of Undergraduate Students

The study evaluates the effectiveness of yoga practices on reducing stress, negative emotion, anxiety, and depression and on increasing positive emotion, wellbeing and resilience. The study uses randomized wait-list control. All U.S. undergraduate students in 4-year universities and colleges age 18 or older are eligible to participate.

The purpose of this project is to widely disseminate a system of yoga tools to university students, faculty, and staff internationally to buffer the psychological impact of the COVID-19 pandemic. A recent study finds that stress, anxiety, and depression are the major psychological responses to COVID-19 during the early outbreaks in China (Wang et al., 2020). Globally, universities have closed campuses and moved learning, teaching, and working online with a very short notice. CDC suggests that keeping physically active and meditation are among the key activities to maintain a strong immune system and mental health during quarantine. Studies have documented physical and mental benefits of yoga practices (Balasubramaniam, Telles, \& Doraiswamy, 2013; Brems, 2015; Brunner, Abramovitch, \& Etherton, 2017; Büssing, Michalsen, Telles, Sherman, \& Khalsa, 2012) This project introduces a system of yoga tools to buffer the psychological impact of COVID-19. This system of yoga tools is designed by Sadhguru Jaggi Vasudev, a yogi, mystic, author, and founder of the Isha Foundation. The Isha foundation is a volunteer-based international non-profit organization, offering yoga and meditation programs for human wellbeing and global harmony. In partnership with the Isha Foundation and Harvard University Medical School, the study will document the short-term and long-term effects of these yogic practices on stress, mood, wellbeing, resilience, and academic engagement for students and work engagement for faculty and staff during this challenging time.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Enrolled in 4-year universities/colleges in 2020
* Not graduate in May 2020

Exclusion Criteria:

* Younger than 18
* Not enrolled in 4-year universities/colleges in 2020
* Graduate in May 2020
CLIP-IT Post-Market Study

The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.

Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ Left Atrial Appendage (LAA) Exclusion Clip at up to 25 sites in the United States.

Subjects will be followed at 30 days, 3 months, 12-months and annually for 36-months.

Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated to be treated with the Penditure™ left atrial appendage (LAA) Exclusion System
* Greater than or equal to 18 years of age
* The subject is willing and able to provide written informed consent and comply with study visit requirements

Exclusion Criteria:

* Prior left atrial appendage (LAA) isolation attempt(s)
* Need for emergent cardiac surgery
* Subject is contraindicated for multi-detector computed tomography (MDCT) and/or transesophageal echocardiogram (TEE)
* Life expectancy of less than 12 months
* History of cardiac surgery
* Pericarditis
* Presence of thrombus in the left atrium or left atrial appendage (LAA), prior to or during the procedure
* Patients requiring a heart transplant, insertion of a ventricular assist device or total artificial heart, and/or ascending aortic aneurysm or dissection repair requiring circulatory arrest
* Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score greater than 4 or subject deemed to be high or extreme risk per surgeon assessment
* Ejection fraction less than 30%
* Chronic Kidney Disease Stage IV or V (estimated glomerular filtration rate (eGFR) \<30 ml/min)
* New York Heart Association (NYHA) Class IV heart failure symptoms
* Patient has a documented history of substance (drug or alcohol) abuse
* Known allergy to device components (Nickel and/or Titanium)
* In the opinion of the investigator, the subject is not a suitable candidate for LAA isolation due to risks outweighing potential benefits including, complexity of planned concomitant procedures, or other pre-existing medical conditions
* Currently participating in an investigational drug or another device trial or study (excluding registries)
Fulvestrant 500mg in Patients With Advanced Breast Cancer

Fulvestrant 500mg in Patients With Advanced Breast Cancer

A multicenter, prospective study real-world to evaluate the safety profile and effectiveness in Chinese patients who received Fulvestrant 500mg as first-line endocrine treatment for Advanced breast cancer

Eligibility Criteria:
Inclusion Criteria:

1. Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer who has already received Fulvestant 500mg treatment as determined by treating physician. Ovarian suppression in premenopausal women is permitted, including ovarian ablation and LHRHa.
2. Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.
3. Prior endocrine therapy for advanced disease was not permitted.
4. The prescription of the Fulvestant is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Fulvestant injection.
5. Provision of subject informed consent.

Exclusion Criteria:

1. If participating in any controlled clinical trial, the subject cannot take part in this study.
2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
3. Pervious regimen of endocrine therapy for advanced disease.
4. More than one regimen of chemotherapy for advanced disease.
5. Pregnancy and lactation.
6. Severe hepatic impairment.
Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion

Maxillary expansion was performed for adult female patients suffering from maxillary constriction with bilateral posterior cross-bite using fixed Quad-helix appliance, for about 8 months. The appliance was delivered and activated at the day of corticotomy and bone graft. The activation was made half-molar unit each side. The patient was scheduled each month to activate the appliance or reactivate if needed. Corticotomy was performed at area of maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was performed, before appliance activation and corticotomy, at the end of expansion (8 months) and after finishing orthodontic treatment (average 2.5 years from start of treatment).

Maxillary expansion was performed for adult female patients suffering from maxillary constriction with bilateral posterior cross-bite \& dental arch discrepancy average 12 mm using fixed Quad-helix appliance, for about 8 months. The appliance was delivered and activated at the day of corticotomy and bone graft (demineralized freeze-dried bone allograft). The activation was made half-molar unit each side. The patient was scheduled each month to activate the appliance or reactivate if needed. Corticotomy was performed at area of maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was performed at three stages.

T1 (baseline) Before appliance activation and corticotomy. T2 At the end of expansion. (about 8 months of expansion). T3 At the finishing stage of orthodontic treatment (average 2.5 years from start of treatment).

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients (18-22 years) suffering from maxillary constriction with bilateral posterior cross-bite.
* Dental arch discrepancy average 12 mm.

Exclusion Criteria:

* Having any given systemic disease.
* Taking any type of medication and/or antibiotic therapy during the 3 months before the study.
* Didn't perform previous orthodontic treatment.
* Current or former smokers.