cyrilzakka/clinical-trials huggingface dataset:
Mindfulness and Chronic Low Back Pain

The purpose of this study is to see if mindfulness, a form of mental training, or listening to a book alters brain activation in response to raising your leg that may produce the feeling of pain. A technique called functional magnetic resonance imaging (fMRI) allows scientists to determine which parts of the brain are active during a particular task. This study will provide new information about how mindfulness affects the brain.

To determine if mindfulness meditation-induced reductions in chronic low back pain (cLBP) patients will be associated with greater anterior insula (aINS), orbitofrontal cortex (OFC), subgenual anterior cingulate cortex (sgACC), and/or thalamic deactivation when compared to rest, the sham-mindfulness meditation and the book-listening control groups. One-hundred and twenty individuals will be randomized to a mindfulness meditation (n=40), non-mindfulness meditation (n=40) and book-listening-control (n=40). Each participants will be administered noxious heat and the chronic low back pain evoking, straight leg raise test during fMRI.

Eligibility Criteria:
Inclusion criteria are:

* Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis. This will be determined over the phone during the (pre) screening and at study session 1, and will not be contingent on MRI.
* Participants must be between the ages of 18-65 years.
* Participants must rate their daily chronic pain intensity at a 3 or greater on 0-10 visual analog scale.
* Participants must have experienced their radicular pain for at least 3 months duration.
* Participants must be right-handed.
* Participants must have no prior meditative experience

Exclusion criteria:

* Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period.
* Participants must not have had back surgery within the last year before their enrollment into the study.
* Participants must not have had any other sensory or motor deficits that precludes participation in this study.
* Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, a personal history of psychosis.
* Participants must not have metal implants including ferrous arterial stints or coils, spinal stimulators, pacemakers, or defibrillators, permanently implanted hearing aides, bullets, BBs, or pellets, retinal eye implants, infusion pump for insulin or other medicines, ferrous surgical clips, staples, metal sutures, orthopedic hardware above or including the shoulders, body piercings that cannot be removed.
* Participants must not be claustrophobic.
* Participants must not produce negative straight leg test (i.e. a test is considered positive when the person reports reproducible pain at 40 degrees of hip flexion or less).
* Participants must not be pregnant
* Participants must not be over 275 pounds
DMBSS-A Randomized Trial of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM

The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2

The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2. This program will determine the relative effectiveness among LMGB 、RYGB and SADJB .The primary end point including HbA1C\<6.0%, LDL-C\<100mg/dl and SBP\<130mmHg at one year after surgery. Through this study, the investigators may understand which gastric bypass is the best for type 2 diabetic's treatment. The investigators also hope some new treatment modulation may be developed.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 67 years
* Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, HbA1c ≥ 7.5 %
* Body Mass Index (BMI) ≥ 27.5 kg/m 2 and ≤ 34.9 kg/m 2
* Willingness to accept random assignment to either treatment group.
* Willingness to comply with the follow-up protocol
* Written informed consent.

Exclusion Criteria:

* Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
* Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
* Cardiac stress test indicating that surgery would not be safe.
* Pulmonary embolus or thrombophlebitis in the past six months
* Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years
* Serum creatinine ≥ 1.5 mg/dl
* History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection
* Previous organ transplantation.
* History of alcohol or drug dependency
* Current participation in a conflicting research protocol.
Clinical Trials of Regeneration for Periodontal Tissue

Adult periodontitis is a chronic infective disease affecting the periodontium. Periodontitis induce the destruction of attachment apparatus of teeth, resulting in periodontal pocket formation and teeth loss. This study will test the safety and efficacy of alveolous bone reproduction by the transplantation of mixture named periodontium injectable gel for the adult periodontitis patients. Injectable gel is the mixture of ex-vivo cultured mesenchymal stem stem cells, ex-vivo cultured osteoblast-like cells differentiated from mesenchymal stem cells and scaffold (include, platelet rich plasma, human thrombin and calcium chloride).

Periodontal disease is an infectious disease. Gingivitis and periodontitis are the 2 major forms of this. Their primary etiology is bacterial plaque, which can induce destruction of the periodontal apparatus. Gingivitis is inflammation of the gingival that does not result in clinical attachment loss. Periodontitis is inflammation of the gingival and is characterized by loss of connective tissue attachment and alveolar bone.

Therapeutic approaches for periodontitis are divided into two categories: 1) anti-infective treatment; 2) regenerative therapy.

Several surgical techniques have been developed to regenerate periodontal tissues including guided tissue regeneration, bone grafting, the use of enamel matrix derivative. However, these techniques are not reached for complete regeneration of the periodontium.

This study will test the safety and efficacy of alveolous bone reproduction by the transplantation of mixture named periodontium injectable gel for the adult periodontitis patients. Injectable gel is the mixture of ex-vivo cultured mesenchymal stem stem cells, ex-vivo cultured osteoblast-like cells differentiated from mesenchymal stem cells and scaffold (include, platelet rich plasma, human thrombin and calcium chloride).

Eligibility Criteria:
Inclusion Criteria:

* 1.Patient with adult periodontitis. 2. There are ４mm or more pocket using . 3.There are ten existing tooth or more of the lower jaw. 4.The brushing instruction is received, and the plaque control is maintained excellently. 5.The recovery by an existing periodontal operation cannot be expected. 6.The age is from 35 to 60 years old. 7.Blood clot function is normal. 8.The liver function is normal. 9.The intention and the ability of going to hospital regularly are possessed. 10.Agreement by the document is obtained.

Exclusion Criteria:

* 1.Patient who has acute symptom of periodontitis. 2.Patient that decayed tooth is on teeth or the next teeth to be treated. 3.Patient who has contracted diabetic or autoimmune disease. 4.Patient who has contracted infectious disease. 5.Patient who has contracted osteoporosis. 6.Patient who has smoking habit within six months before it registers. 7.Patient who is taking treatment of hypertension and/or epilepsy. 8.Patient who has pregnancy or doubt of pregnancy. 9.Patient who has heavy allergic disease.
The EMPA-FIT Study

This multicenter, open-label, prospective study randomized 46 drug-naïve adults with T2D (HbA1c 6.5%-10.0%) to receive empagliflozin (10 mg/day) or metformin (1,000 mg/day) for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants were eligible if they had T2D with an HbA1c between 6.5% and 10.0%, were between 20 and 75 years of age, and had not received any anti-diabetic medications for at least eight weeks prior to screening.

Exclusion Criteria:

* individuals with a body mass index (BMI) \<18.5 kg/m² or ≥40 kg/m², clinically significant hepatic impairment (e.g., hepatic cirrhosis, portal hypertension, chronic active hepatitis), or a history of acute cardiovascular events (e.g., coronary artery disease, cerebrovascular disease, peripheral arterial disease) within two months prior to enrollment. Participants with CKD (eGFR \<60 mL/min/1.73 m²) or end-stage renal disease (eGFR \<15 mL/min/1.73 m² or on dialysis) were also excluded.

Additional exclusion criteria included uncontrolled hypertension (BP ≥160/100 mmHg), New York Heart Association (NYHA) class III or IV heart failure, chronic oral corticosteroid use (\>30 consecutive days), a history of cancer (except basal cell carcinoma) within the past five years, or significant dyslipidemia (triglycerides \>1,000 mg/dL or LDL cholesterol \>250 mg/dL).
Acupuncture for Pain Control After Elective Caesarean Section

The study entitled "Acupuncture vs. placebo acupuncture and vs. standard therapy for pain control after elective caesarian section - a randomized controlled trial" aims to investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement as compared to placebo and standard therapy in patients after after elective caesarian section (CS) in the period from January 2015 to May 2016.

For that purpose 180 adult patients scheduled to elective elective CS in spinal anesthesia will be recruited according to eligibility criteria. 120 patients will be randomized either to verum or placebo acupuncture, 60 patients will be included in non-randomized "standard therapy" arm. The outcome measures are: postoperative analgesic requirement, pain intensity, incidence of side effects and physiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an American Society of Anaesthesiologists physical status of I to III scheduled for elective caesarean section in spinal anaesthesia
* Surgery time does not exceed 60 minutes
* Patients without previous opioid and psychotropic medication
* Patients ranged 19-45 years old
* Patients who have given written informed consent

Exclusion Criteria:

* Recidivist alcoholics
* Local skin infection at the sites of acupuncture
* Age \< 19 and \> 45 years
* Switching to general anaesthesia in cases where spinal anaesthesia fails
* Surgery time more than 60 minutes
* Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines except for short hypotension after induction of spinal anaesthesia )
* Patients who consumed opioid medication at least 6 months before surgery
* Patients who are unable to understand the consent form and fill in the study questionnaire
* History of psychiatric disease
Global Study of Del-desiran for the Treatment of DM1

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Global Study to Evaluate the Efficacy and Safety of Intravenous Delpacibart Etedesiran (abbreviated del-desiran, formerly AOC 1001) for the Treatment of Myotonic Dystrophy Type 1

The study consists of a Screening Period of up to 6 weeks and 54-week Treatment Period. The anticipated duration is approximately 60 weeks.

Participants will be randomized to receive an intravenous infusion of either del-desiran or placebo at the clinical study site every 8 weeks for a total of 7 doses. The final dose will occur at Week 48, followed by a final assessment at Week 54.

After completion of Week 54 assessments, eligible participants will have the option to enroll into an open label extension (OLE) study, pending regulatory approval.

An Independent Data Monitoring Committee (IDMC) comprised of members independent and external to the Sponsor will review safety, tolerability, and efficacy (as needed) data of this study at regular intervals.

Eligibility Criteria:
Key Inclusion Criteria:

* Clinical and genetic diagnosis (CTG repeat ≥ 100) of DM1
* Ability to walk independently (orthoses and ankle braces allowed) for at least 10 meters at screening

Key Exclusion Criteria:

* Breastfeeding, pregnancy, or intent to become pregnant during the study
* Unwilling or unable to comply with contraceptive requirements
* Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study
* Diabetes that is not adequately controlled
* History of decompensated heart failure within 3 months of screening. Participants with preexisting pacemaker/ICD are not excluded.
* Body Mass Index \> 35 kg/m2 at Screening
* Recently treated with an investigational drug or biological agent
* Treatment with anti-myotonic medication within 5 half-lives or 14 days of baseline, whichever is longer, prior to baseline.

Note: Additional protocol defined Inclusion and Exclusion criteria apply
Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation

The purpose of this study is to assess the changes in language processing of patients with chronic aphasia after receiving non-invasive brain stimulation.Previous research using traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has shown that persons with aphasia show more improvement after treatment when that treatment is accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver current to more specific locations in the brain. This new delivery method is called high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse current delivery) or HD-tDCS (more focal current delivery) will be the better approach for enhancing treatment outcomes. To answer this question, computerized speech-language treatment will be administered during the application of the different forms of brain stimulation.


Eligibility Criteria:
Inclusion Criteria:

1. one-time ischemic stroke in the left hemisphere
2. greater than 6-months post-stroke onset
3. between 25 and 80 years of age
4. aphasia diagnosis (as determined by pre-treatment language-based testing)
5. right-handed (before the stroke)
6. native speaker of English
7. ability to provide informed written or verbal consent

Exclusion Criteria:

1. clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
2. factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
3. prior history of epileptic or unprovoked seizures occurring during the previous 12 months.
Vitamin Supplementation After Bariatric Surgery

The objectives in this study are to provide information on the efficacy of transdermal supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric patients, and to determine short-term body composition, HbA1c and fasting plasma glucose outcomes for patients after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients currently approved for vertical sleeve or gastric bypass bariatric surgery
* female patients should not be pregnant or plan to become pregnant

Exclusion Criteria:

* metal objects in the body
* current weight greater than 600lbs
* previous bariatric (revision) surgery
Vitamin D 2 to Dialysis Patients

Vitamin D is necessary for healthy bones. Vitamin D is made in our skin when we are exposed to sunlight, but it is also found in foods that we eat and in vitamin pills. Low levels of vitamin D are common in many groups of people, because we do not get enough sun during the winter and because we eat few foods that have vitamin D in them. Some foods with vitamin D are salmon, mackerel, tuna, and fortified milk, which has had vitamin D added to it.

We know that nearly all kidney disease patients on dialysis do not have enough vitamin D in their bodies. We believe this condition can cause muscle weakness, leading to falls and broken bones. These are common problems for patients who are receiving dialysis. For example, dialysis patients have a much higher risk of hip fractures (broken hips). However, no formal research has been done on patients with low vitamin D levels receiving dialysis, to see if they actually have muscle weakness and related problems.

There are two goals of this study. First, we want to see if patients on dialysis who have low vitamin D levels are actually at risk for muscle weakness, muscle pain, and broken bones. We also want to find out if giving vitamin D pills to these patients will result in better muscle strength, less muscle pain, and fewer falls.

In this study, we will compare vitamin D to placebo. Placebo capsules look exactly like vitamin D capsules but contain no active ingredients. We use placebos in research studies to be sure that the study results are due to the study drug and not to other reasons.

Inclusion criteria:

Age ³ 18, CKD on hemodialysis, men and women, hemoglobin ³ 9g/dl, albumin ³ 3.0g/dl, no recent (in the last three months) admissions to the hospital, ability to walk ten feet with or without a walking aid.

Exclusion criteria:

Subjects who are pregnant or lactating; subjects with history of kidney stones, malabsorption syndromes, tertiary hyperparathyroidism defined by a parathyroid hormone of \>500pg/ml, current use of corticosteroids, non-ambulatory subjects (for example paraplegic subjects), serious fracture in the last three months, and corrected calcium levels of 10.5 mg/dl or greater.

Eligibility Criteria:
Inclusion criteria:

* Age ³ 18
* CKD on hemodialysis
* Men and women
* Hemoglobin ³ 9g/dl, albumin ³ 3.0g/dl,
* No recent (in the last three months) admissions to the hospital
* Ability to walk ten feet with or without a walking aid.

Exclusion criteria:

* Subjects who are pregnant or lactating
* Subjects with history of kidney stones
* Malabsorption syndromes
* Tertiary hyperparathyroidism defined by a parathyroid hormone of \>500pg/ml, current use of corticosteroids
* Non-ambulatory subjects (for example paraplegic subjects)
* Serious fracture in the last three months, and
* Corrected calcium levels of 10.5 mg/dl or greater.
Standard Duodenal Switch vs. Single Anastomosis Duodeno-Ileostomy Duodenal Switch

The aim of the Torsby I Trial is to identify differences and similarities between a standard duodenal switch (DS) and a single-anastomosis duodeno-ileostomy (SADI) regarding effect on weight, comorbidities and malnutrition.


Eligibility Criteria:
Inclusion Criteria:

* BMI over 45
* Ability to understand the legal background of a study

Exclusion Criteria:

* Previous bariatric or anti-reflux surgery
* Drug-abuse
* Inflammatory bowel disease
* Complex psychiatric situation
An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)

The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in subjects with hyperuricemia in an inpatient, controlled setting.

This is a Phase II, 7-day, randomized, double-blind, placebo-controlled study of orally administered ALLN-346 in subjects with hyperuricemia, with subpopulations to include generally healthy hyperuricemic subjects with normal kidney function and those with mild to moderate chronic kidney disease (CKD). Study will take place at a clinical pharmacology unit (CPU). The study will have two Parts. Part 1 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR ≥ 60 mL/minute/1.73 m2 (subjects with eGFR of stage 2 CKD and with normal kidney function). Part 2 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR 45-100 mL/minute/1.73 m2 (eGFR of CKD Stages 2- 3a).

The study will evaluate safety, tolerability, pharmacokinetics (lack of absorption) and pharmacodynamics of ALLN-346.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 55 years
* sUA level ≥ 6.8 mg/dL at Screening (hyperuricemia), with or without a diagnosis of gout
* Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
* Normal non-clinically significant abnormalities in vital signs
* Normal clinical laboratory test results and ECG, which are not considered to be clinically significant

Exclusion Criteria:

* Screening eGFR of \<60 mL/minute/1.73 m2 for Part 1, and for Part 2 Screening eGFR outside the range of 45-100 mL/minute/1.73 m2.
* History or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, urological, or psychiatric disorders.
* Presence or history of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines
* Currently taking any urate-lowering medication within 4 weeks prior to Day 1 (first dosing day)
* Prior uricase therapy or exposure to recombinant uricase
* Clinically significant abnormal findings on electrocardiogram (ECG)
* Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody
* Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening
* Prior dosing in ALLN-346 clinical study
* Per Investigator judgment, is not an ideal clinical study candidate
Validating a Modified COMPASS 31questionnaire for Treatment Outcomes

Eligible participants will complete the COMPASS 31 (year), modified COMPASS 31(one month) and the NSI (one month) questionnaires at baseline and complete the modified COMPASS 31 and the NSI after usual care of treatment.

The investigators will

1. Compare results for the COMPASS 31(year) to the modified COMPASS 31(month) at baseline.
2. Compare modified COMPASS 31(month) to the NSI at baseline and post intervention.

The Composite Autonomic Symptom Score (COMPASS 31) is a validated questionnaire designed to measure self reported autonomic symptoms in the last year in individuals with migraine and post-concussive symptoms. In order to use this questionnaire to measure response to treatment it would be preferable to determine if the results of the COMPASS 31 are similar if the patient is asked to complete this thinking about symptoms in the last year as per the usual questionnaire, compared to a modified COMPASS 31 where symptoms in the past month will be assessed.

This prospective trial will compare results of the COMPASS 31 (year) to the modified COMPASS 31 (month). Since the present gold standard for outcome measures in post-concussive treatment is the neurobehavioral symptom inventory (NSI), this study will also compare results of the modified COMPASS 31(month) to the NSI outcome measure at baseline and post treatment to validate the utilization of the modified version of the COMPASS 31(month) for use in the post-concussive population as an outcome measure for self-reported autonomic nervous system symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present to the BAMC_BIRS clinic for treatment of headache between the ages of 18-64.

Exclusion Criteria:

* Normal composite autonomic symptom score.