cyrilzakka/clinical-trials huggingface dataset:
Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure

Mesenchymal stem cells (MSC) has been reported to improved outcomes of acute-on-chronic liver failure(ACLF). More randomization controlled studies are needed to confirm the effect of MSC treatment for ACLF. This study aimed to investigate the efficacy of mesenchymal stem cells in ACLF patients. This study is an double-blind multicenter randomized and placebo-controlled study. Patients with with ACLF will be randomly assigned to receive MSC treatment (experimental) or standard medical treatment (control). Three times of MSC infusion (0.1-1x10E6cells/kg body weight) via peripheral vein will be given to the experimental group (once per week). The primary outcome is 12 week mortality. Secondary outcomes are clinical remission rate and changes of liver function indices and liver function scores.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years old
* Meeting the criteria of ACLF defined as: 1. definitive chronic liver diseases, acute decompensation within 4 weeks; 2. Significant GI symptom as such fatigue, jaundice,; 3. total bilirubin (TBIL) ≥170 µmo1/L or daily increase of TBIL ≥17.1 µmo1/L; 4. PTA≤40% or INR≥ 1.5; 5. Decompensation of liver functions such as ascites or hepatoencephalopathy;
* MELD score between 17-30. (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643)
* Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
* Informed consent

Exclusion Criteria:

* Sever complications with 30 days ( GI bleeding, severe infection)；

  --liver cancer or other malignancies
* patients on liver transplantation list
* patients with uncontrolled infections
* severe renal failure
* Severe chronic obstructive pulmonary disease COPD (GOLD III-IV)
* Extrahepatic cholanstasis patients due to biliary obstruction.
* HIV infection
* Pregnant or breast-feeding females.
* Enrolled in other clinical trials with 3 months
* other conditions considered inappropriate for the study
TAP Block Alone Versus TAPblock With Rectus Sheath Block in Liposuction Surgery

The transversus abdominis plane (TAP) block is an effective regional nerve block for the anterior abdominal wall. An anesthesiologist typically administers the TAP block preoperatively with ultrasound guidance. It is not yet commonly used during anterior abdominal wall liposuction, where postprocedural pain remains a major concern for patients and surgeons.

The author investigated the feasibility of administering the TAP block under direct vision and compared postoperative narcotic use in patients who received analgesia by TAP block vs with TAP block i addition to rectus sheath block, both performed under direct vision during anterior abdominal wall liposuction.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II, consent,

Exclusion Criteria:

* allergy, coagulopathy, refusal, mentally unstable
Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

The purpose of this study is to determine whether a computer navigational unit can improve operating time and consistency during Knee arthroplasty when compared to knee arthroplasty without a computer navigational unit.

The ability to use a computerized navigational unit during knee arthroplasty can be a major benefit to surgeons that perform a small amount of knee arthroplasties. Navigational assistance can decrease surgery and anesthesia time as well as decreasing variation in posterior tibial slope and improved range of motion.

Eligibility Criteria:
Inclusion Criteria for the Oxford Knee

* symptomatic unicompartmental knee arthritis major surgery
* failed non operative treatment modalities
* willing and able to give informed consent
* skeletal maturity

Exclusion criteria for the Oxford Knee

* medical conditions that preclude general or spinal anesthetic
* ipsilateral knee avascular necrosis
* severe osteoporosis or osteopenia
* neuromuscular impairment
* ipsilateral knee infection

Patient day surgery criteria

* medically stable: an ASA category of 1 or 2
* close proximity to the hospital surgery performed for at least 36 hours
* good support system in place- someone able to stay with the patient for at least 36 hours immediately post-op.
* hemovac to be removed prior to discharge
* access to VON or other home care hospital approved services
* pain buster for pain control for 24 to 36 hours
Implementation of Climb Up Program for Children With Attention Deficit Hyperactivity Disorder (ADHD) and Dyslexia in a School in India

A multimodal intervention was rolled out at a large public school in Najibabad, Uttar Pradesh (UP). The program identified elementary school children with ADHD and Dyslexia using standard screening of all children who had performance impairment in at least one domain of the Vanderbilt questionnaire. The program consisted of play therapy, physical exercise, yoga and meditation. The program was established by High school volunteers from The US and UK over 6 weeks. Once implemented during the morning of school, high school volunteers from the school were trained to continue the program. Vanderbilt questionnaires were completed at intervals to allow follow up.


Eligibility Criteria:
Inclusion Criteria:

* All children between 6 and 11 years attending MDKV public school in Najibabad, UP who had assessment performed for ADHD or Dyslexia

Exclusion Criteria:

* Children who were not enrolled by the parents
Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

Objective: To examine the potential of dextrose injection versus lidocaine injection versus supervised usual care to change pain/function/activity levels in adolescent athletes with Osgood-Schlatter Disease (OSD).

Patients and methods: Girls ages 9-15 years old and boys ages 10-17 years old will be assigned to either therapist-supervised usual care, or to double-blind injection of 1% lidocaine solution with or without 12.5% dextrose. Injections will be administered monthly for three months. All subjects will then be offered dextrose injections monthly as needed. Change in the Nirschl Pain Phase Scale (NPPS) will serve as the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Age:9-15 year old girls and 10-17 year old boys
* Pain Location: Anterior knee.
* Sport Type: Jumping or kicking sport.
* Team Member with Coach: Member of and organized team with a coach.
* Imitation of exact pain and precise location to the tibial tuberosity with a single leg squat.
* At least 2 months of formal and gently progressive hamstring stretching, quads strengthening, and gradual sports reintroduction.
* Pain with sport at least 3 months.

Exclusion Criteria:

* Patellofemoral crepitus
* Patellar origin tenderness
Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)

This study will evaluate if Ursolic Acid supplementation may be effective in reducing muscle loss and improving blood sugar control in the SCI community.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female individuals with paraplegia having chronic (\> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from T2-T8
2. Male and female individuals wi4.th chronic (\> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7

Exclusion Criteria:

1. Pregnant or planning to become pregnant
2. Women who are breastfeeding
Effect of Liraglutide on Blood Glucose Control in Japanese Subjects With Type 2 Diabetes

This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy
* 7.0 % =\< HbA1c \< 10.0 %
* Body Mass Index (BMI) \< 30.0 kg/m\^2

Exclusion Criteria:

* Subjects treated with thiazolidinediones or insulin
* Subjects with any serious medical conditions
Behavioral Smoking Cessation Treatment - 1

Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. We will also conduct secondary analyses of mediators and moderators of treatment response.

400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All smokers will receive the same "Acute Phase Treatment" that combines nicotine patch, bupropion and intensive self-regulatory skills training. Nicotine patches will be provided for 8 weeks and bupropion and skills training will be provided for of 9 weeks. Participants will then enter a "Maintenance Treatment Phase" during which half (n=200) will receive three individualized relapse prevention training sessions spread over a 12 week period. They will also receive 12 weeks of self-administered RPT administered via written treatment modules. Finally, telephone counseling will be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=200) will be assigned to a control condition that consists of three counselor-led sessions of "supportive therapy" spread over a 12 week period. P

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult cigarette smokers smoking at least 10 cigarettes per day

Exclusion Criteria:

* Currently pregnant
* Currently breastfeeding
* Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure
* History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
* Family history of seizures
* Currently using intravenous drugs
* Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
* Currently using any over-the-counter stimulants and anorectics (diet pills)
* Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
* Currently on NRT or bupropion (Zyban)
* Current or past diagnosis of anorexia nervosa or bulimia nervosa
* Previous allergic response to bupropion or NRT
* Previous failed quit attempt using NRT and bupropion in combination
Kinesio Tape vs Neuromuscular Stimulation For Conserative of Treatment Hemiplegic Shoulder

This study aimed to compare the effects of kinesiotaping, neuromuscular electric stimulation (NMES), and neuromuscular training on pain, and motor activity and function in patients with upper extremity hemiplegia.

Hemiplegia in the shoulder complex and upper limb is a common secondary impairment as a result of a cerebrovascular event. Although most stroke survivors regain independent ambulation, many fail to regain functional use of their impaired upper limb. Actually the pathogenesis of post-stroke shoulder pain seems to be multifactorial; differential diagnosis is often difficult. Changes in the shoulder complex makes the glenohumeral joint vulnerable to subluxation, which may cause pain. Traction of capsule and soft tissue related subluxation of the shoulder may take place in the early stages; limited range of motion due to spasticity may develop in the later stages of stroke. These biomechanical problems may be the possible reason for pain. Rotator cuff tears and rotator cuff and deltoid tendinopathies are also possible symptoms related to hemiplegic shoulder observed in magnetic resonance imaging findings. These problems in the shoulder disturb the kinetic chain system that connects the segments and works sequentially from proximal to distal to achieve the targeted movement. When a biomechanical impairment happens in the shoulder or any other segment of the body, a loss in the energy produced in the body and transferred to the upper extremity occurs. This loss adversely affects the quality of the movement .

Regaining functional use of the upper limb after a stroke is a challenging task for the patient, which has a significant impact on the individual's physical, psychological, and emotional well-being. Lack of functional ability in the upper extremities after stroke restricts use and causes asymmetric posture and contracture in daily life, thus exacerbating functional limitations of the upper limb. Also, low upper limb motor function is related to the risk of soft tissue injury during rehabilitation. A patient experienced a stroke may not feel any pain due to subluxation. However, different muscle groups may be vulnerable to overstretching, increased contraction, and premature fatigue. This can decrease the coordination of muscular activity and inhibit the functional use of the upper extremity. The posterior fibers of the deltoid, the supraspinatus, and the infraspinatus are the most important muscles that prevent the subluxation of the glenohumeral joint.

Eligibility Criteria:
Inclusion Criteria:

* had unilateral ischemic brain injury or intracerebral hemorrhage at least 1 week to maximum 24 months after the onset of single stroke without other diagnosed neurological or systematic deficits.
* had enough cognition to be able to follow the training protocol as assessed by Mini Mental State Examination.
* age 30-70 years.

Exclusion Criteria:

* had a severe injury of the rotator cuff or a shoulder surgery history.
Evaluation of Procalcitonin (PCT) as a Marker of Infection Post Living Donated Liver Transplant

, the study aimed at assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.

All patients transferred from operative theatre to ICU will be sedated, intubated \& ventilated. They will receive empiric antimicrobial prophylaxis upon admission \& early immunosuppression according to the clinical practice guidelines in our center, (Appendix 1).

Preoperative patients' demographic data will be obtained. Model for end-stage liver disease (MELD) prior transplant, the primary cause of liver transplant.

Operative \& anesthetic details; operation time, units of blood, blood products transfusion, ischemic time, type of preservatives used, back table procedures, extra-hepatic procedure \& graft to recipient weight ratio will be recorded.

Postoperative patient evaluation will include; Sequential Organ Failure Assessment (SOFA) on admission \& /48h. Hemodynamic monitoring will include hourly measurement of heart rate, mean arterial pressure (MAP), temperature, central venous pressure (CVP), arterial oxygen saturation (SaO2), daily total volume of fluid infused, urine output, fluid balance daily, blood gases / 6h \& daily mean values will be recorded till hospital discharge.

Routine laboratory workup includes biochemical markers of liver, kidney function and hematological parameters (complete blood count \& coagulation profile).

Patient evaluation for infection will be done through scheduled measurements of PCT every other day during ICU stay \& upon needed during the hospital stay. Other markers of infections will be measured till hospital discharge as C-reactive protein (CRP) every other day, daily total leukocyte count (TLC) \& band cells %.

Microbiological evidence of infection will be confirmed by cultures that will be regularly sampled every other day during ICU stay \& upon any clinical or laboratory biomarker suggestive of infection.

Management of suspected infection; when PCT value rising with clinical, radiological \&/or laboratory evidence of infection (TLC, CRP, band%), culture from suspected site of infection will be withdrawn. If the source of infection is not evident, cultures from; blood, urine, sputum, surgical wound, drain \& nasal swab will be withdrawn \& empiric antimicrobial against gram +ve bacteria will be initiated. While the management of proven infection will be culture based antimicrobial initiation.

Eligibility Criteria:
Inclusion Criteria:

* including adult patients aged ≥18 years old who are recipients for living donated liver transplantation (LTx) at the Department of Liver Transplant of National Hepatology \& Tropical Medicine Research Institute (NHTMRI), between January 2014 and January 2018 \& with no contraindications for early immunosuppression.

Exclusion Criteria:

* Patients will be excluded from the study if they are readmitted or had primary graft nonfunction.
Improving Aspirin Use in Diabetes: A Cluster Randomized Trial

Our aim is to determine if a patient-directed intervention is more effective than computerized clinician reminders alone for improving aspirin use in adults with diabetes.

Many patients with diabetes do not use aspirin to prevent cardiovascular events. Quality improvement initiatives involving both patients and physicians may be more effective than physician-directed approaches alone.

In a large urban primary care internal medicine practice, this study seeks to test if a patient-directed intervention is more effective than computerized clinician reminders alone for improving the appropriate use of aspirin in adults with diabetes.

The study design is a cluster-randomized trial by physician. The frequency of self-reported regular aspirin use will be compared between patients cared for by physicians in the computerized reminder alone group and the computerized reminder plus physician-supervised, nurse practitioner intervention group.

Eligibility Criteria:
Inclusion Criteria:

Diabetes mellitus

* Age at least 40 years old
* At least 2 clinic visits in the 18 months prior to the intervention

Exclusion Criteria:

* Primary care physician declined enrollment
A Single Arm Study of Traditional Chinese Medicine for Plasma Cell Mastitis

This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis.

This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis. This study will include 50 patients with plasma cell mastitis. After providing written informed consent, the participants will receive traditional herbal medicine twice daily. Efficacy will be assessed every 15 days. If the disease progresses, the participant will withdraw from the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for plasma cell mastitis.
2. Women aged \> 20 years and ≤ 60 years.
3. Karnofsky Performance Status (KPS) Scale score ≥ 70.
4. Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups.

Exclusion Criteria:

1. Pregnant and lactating women; fertile women who provide positive results of baseline pregnancy test; women of childbearing age who are unwilling to take effective contraceptive measures during the whole study period.
2. Patients with serious underlying diseases, such as diabetes, cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system diseases.
3. Allergic constitution, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of the drugs used in this trial.
4. Recent use of antidepressants and other psychotropic drugs.
5. Hormone and immunosuppressive therapy were used one month before enrollment.
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
2. Participant has had a colonoscopy performed:

   * Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)
   * Since the onset (if applicable) of any of the following alarm features for participants of any age:

     * Participant has documented weight loss within the past 6 months
     * Participant has nocturnal symptoms
     * Participant has a familial history of first-degree relatives with colon cancer or
     * Participant has blood mixed with their stool (excluding blood from hemorrhoids).
3. Female participants must be:

   * Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
   * Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
   * Abstinent, or
   * If sexually active, be practicing an effective method of birth control.

Exclusion Criteria:

1. Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
2. Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
3. Participant has a history of diverticulitis within 3 months prior to Prescreening.
4. Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
5. Participant has any of the following surgical history:

   * Cholecystectomy with any history of post cholecystectomy biliary tract pain
   * Any abdominal surgery within the 3 months prior to Prescreening
   * Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.