cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel

What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel.

It is the investigators' hypothesis that a peel of the subscapularis will result in greater strength, a higher healing rate, and a greater improvement in shoulder function and quality of life following shoulder replacement.

The primary research question is to determine the difference in subscapularis strength between two different methods of subscapularis mobilization in shoulder arthroplasty: intra-substance division of the tendon "tenotomy" versus direct detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel". The primary outcome is strength as measured by a hand-held dynamometer in the belly-press position at one-year post operative. Secondary research questions include determination of the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy versus subscapularis peel, as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), Constant score and the ASES score at one year post-operatively. Finally, the healing rate of the subscapularis, as measured by ultrasound at 1 year post-operative will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Imaging, and intra-operative findings confirming advanced humeral head cartilage loss, and/glenoid cartilage loss.
* Ability to understand and adhere to rehab protocols and testing procedure
* Persistent pain and functional disability for at least 6 months and failure of 6 months of conservative treatment
* surgical arthroplasty patients

Exclusion Criteria:

* Active joint of systemic infection
* Significant muscle paralysis
* Rotator cuff tear arthropathy
* Pregnancy
* Charcot's arthropathy
* Major medical illness ( life expectancy less then 1 year or unacceptably high operative risk)
* Patients unable to provide informed consent due to language barrier or mental status
* Unable to speak or read English/French
* Psychiatric illness that precludes informed consent
* Patients unwilling to be followed for the duration of the study.
Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery

This study will evaluate what is the impact of laparoscopy and Trendelenburg position on lung regional ventilation distribution in obese patients, focusing on the differences between the different phases of surgery.

Electrical impedance tomography (EIT) is a non invasive monitoring technique that allows to evaluate the regional distribution of ventilation. EIT has been used in different contexts, such as acute respiratory failure or intraoperative ventilation settings. Obesity, by increasing intrabdominal pressure, may reduce functional residual capacity after anesthesia and therefore require a more aggressive intraoperative ventilatory setting. In addition, laparoscopy, by increasing the volume of the abdomen, further pushes the diaphragm and increase the probability of lung collapse.

The aim of the current study is to describe the effect of 1) anesthesia and of 2) laparoscopy and trendelenburg position on regional ventilation distribution. Moreover, the investigators will evaluate if the best ventilatory parameters set after anesthesia induction are confirmed also when the condition changes (i.e. during pneumoperitoneum and trendellenburg).

Finally, the investigators will explore if the different parameters which can be provided by EIT agree in suggesting the best level of positive-end expiratory pressure in both moments of surgery.

Eligibility Criteria:
Inclusion Criteria:

* age 18-90 years
* Body mass index \> 30 kg/m2
* Major surgery
* Predicted duration of surgery \> 2 hours
* Predicted presence of invasive arterial pressure monitoring

Exclusion Criteria:

* emergency surgery
* Refuse to participate from patient
* presence of Implantable cardiac device or pacemaker
* thoracic wounds
* thoracic surgery
Promoting Family Health, Happiness, and Harmony Through a Community-based "Learning Family" Campaign

According to the Social Welfare Department statistics, Kwun Tong has been ranked as the highest for the reported cases of elderly abuse (12.3%), the second and fourth highest for the reported cases of battered spouse (9.2%) and child abuse (7.9%) respectively. To strengthen family well-being in the Kwun Tong community, the investigators adopt a community-based participatory (CBP) approach and implement a community-based "Learning Family" campaign in Kwun Tong district with the investigators collaborator, the Christian Family Service Centre (CFSC). The campaign aims to promote family health, happiness, and harmony (3Hs) through cultivating cooperative and self-regulated family learning culture in Kwun Tong district.

Family well-being, which has been conceptualized as "family-life satisfaction", "sense of well-being" and "family function", is associated with outcomes such as hypertension, self-rated health, depression, and self-esteem in family members. Interpersonal harmony in the family is believed to be crucial for the Chinese who see it as contributing not only to each individual member's welfare but also to a well-organized and peaceful world. According to traditional Confucius ideals, family harmony is the basis for an individual's happiness. The investigators qualitative studies in Hong Kong have also found that family health, happiness and harmony (3Hs) are three major themes of family well-being. Family health includes physical and mental health of family members, which is strongly related to psychological capital and family unity. Family happiness can be enhanced by spending time with family members and building connection with friends and relatives. Family harmony means absence of conflicts and effective communication with family members. Forbearance and spending time with family are important in forming a harmonious family.

Learning Families Project was initiated based on the social ecological model. Social ecological model is a framework to examine the dynamic interrelations among various personal and environmental factors. This model emphasizes people's behaviors are affected by factors of different levels including intra-personal, inter-personal, community and societal factors. These programs promoted the concepts of Learning Family and family 3Hs to the participants (intra-personal level). The concepts of Learning Family indicated that family relationship could be improved when family members learnt something together. These programs also provided a platform for family members to learn together and communicate with each other (inter-personal level), as well as for residents to interact in these community activities (community level).

Eligibility Criteria:
Inclusion Criteria:

* Residents living in the intervention estate
* Hong Kong residents
* Older than 10 years of age
* Could communicate in Chinese (Cantonese or Putonghua)

Exclusion Criteria:

* Participants who fail to meet the inclusion criteria
A Study of LY3127760 in Healthy Participants

The main purposes of this study are to evaluate the safety and how well the body handles single and multiple doses of increasing strength of study drug, LY3127760. This study includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or females as determined by medical history and physical examination
* Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
* Female participants not of child-bearing potential
* Have a body mass index of 18.5 to 32 kilograms per square meter (kg/m\^2) inclusive
* Are normotensive (defined as supine systolic blood pressure \[BP\] less than 140 millimeters of mercury \[mm Hg\] and diastolic BP less than 90 mm Hg) without use of any antihypertensives

Exclusion Criteria:

* Have known allergies to LY3127760, related compounds or any components of the formulation, celecoxib or sulfonamides, or history of significant atopy. Participants with known aspirin allergy or allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded
* Have any current or prior history of a significant gastrointestinal illness such as peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea
* Have evidence of other chronic liver disease, including but not limited to chronic alcoholic disease, nonalcoholic steatohepatitis, recent history (within 3 months of screening) of acute viral hepatitis or chronic autoimmune hepatitis
* Have used any NSAIDs, celecoxib, aspirin or acetaminophen (at doses greater than 1 gram per day), anticoagulants or antiplatelet agents within 14 days of admission

Part 2 and Part 3 only

* Have 1 plus pretrial pitting edema or 2 plus ankle or pedal edema
Prophylaxis of Gastrointestinal Infections With EcN

This interventional trial shall investigate the efficacy and tolerance of a suspension with non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. coli bacteria of the non-pathogenic Nissle 1917 strain at a concentration of 10exp8 cells per ml.

Newborns (treatment-group E) and infants at the age of 6 months (treatment-group L) shall be treated with 1 x 1 ml ECN-SUSPENSION for 10 days and observed until the age of 12 months.Treatment-group E (newborn) will receive EcN-Suspension on the first 10 days of life and will be observed for the next 12 months. Treatment-group L (infants at the age of 6 months) will receive EcN-Suspension on the first 10 days of their seventh month of life and will be observed for the next 6 months.The corresponding control group will remain untreated and will be observed only for 12 months. According to the hospitals daily routine the inclusion and exclusion criteria will be checked. All newborns meeting the inclusion criteria will be included into the trial. Patients' anamnestic data and general health status are recorded at the initial control.Controls are performed according to the time schedule normally used in the hospital functioning as a trial site. According to this, during each monthly control data on the efficacy and safety are recorded. The final control for assessing the tolerance and efficacy of the trial medication is conducted along with a physical examination after an observation period of 12 months.In this study, diarrhea is defined as increase of stool frequency to \>3 watery or loose stools in 24 hours on at least two or more consecutive days.The prophylaxis against gastrointestinal infections with EcN-Suspension is expected to result in a decrease of the number episodes of diarrhea in comparison to the untreated control. The primary efficacy criterion is the number of episodes of diarrhea caused by gastrointestinal infection within the first 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed by the patient's parents or legal guardians.
* Term born infants.

  * Age \< 2 days
  * Gestational age from 38-42 weeks of gestation
  * Birth weight from 2500-3750 gr.
  * Normal delivery (eutocia)

Exclusion criteria:

* Simultaneous participation in another clinical study
* Consumption of food supplements or medicines containing live micro-organisms or their metabolic products or components during the study
* Other reasons which in the opinion of the investigator provide a reason against the inclusion of the patient in the study.
* Autoimmune disease·Severe sepsis or severe systemic injury
* Immunosuppressive treatment
* Severe co-morbidities diseases of the:

  * Heart
  * Liver
  * Kidney
* Genetic disease
* Other serious associated diseases, which in the opinion of the investigator, cast a doubt on the implementation of the test according to the study protocol.
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes

This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for \>=3 months prior to screening;
* stable weight +/-10% for \>=3 months before screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* acute gastrointestinal symptoms at screening and/or day -1;
* clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.
Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)

The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects at least 18 years of age
* Subject has a diagnosis of Rheumatoid Arthritis (RA) as defined by either the 1987-revised American College of Rheumatology (ACR) classification criteria or the new ACR/ European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider
* Subject must meet the following criteria:

  1. Disease Activity Score of C-reactive Protein (DAS28\[CRP\]) ≥ 3.2 (at the Baseline visit only)
  2. At least 6 swollen joints out of 66 assessed (at the Screening and Baseline visits)
  3. At least 8 tender joints out of 68 assessed (at the Screening and Baseline visits)
  4. C-reactive protein (CRP) ≥ 1.5 mg/dL (at the Screening visit only), or erythrocyte sedimentation rate (ESR) ≥ 28 mm/1h (at the Screening and Baseline visits)
  5. Fulfill at least one of the following three criteria: Rheumatoid Factor (RF) positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide (anti-CCP) antibody positive
* Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during Screening

Exclusion Criteria:

* Subject has previous exposure to any systemic biologic therapy including adalimumab
* Subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (DMARDs) or with methotrexate (MTX)
* Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study)
* Subject has chronic arthritis diagnosed before age 17 years
* History of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB)
* Hepatitis B virus: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the hepatitis B virus DNA (HBV DNA) polymerase chain reaction (PCR) qualitative test
* Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline visit
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of strontium or radiation therapy in treating patients with prostate cancer that is refractory to hormone therapy who have painful bone metastases.

OBJECTIVES: I. Compare, in a randomized Phase III setting, the subjective response rate, time to progression, and survival of patients with hormone-refractory prostate cancer with painful osseous metastases treated with either strontium-89 or palliative local radiotherapy. II. Compare the quality of life achieved on these two regimens. III. Determine the toxicity and morbidity of treatment on these two regimens. IV. Compare the cost effectiveness of these two regimens.

OUTLINE: Randomized study. Arm I: Radioisotope therapy. Strontium-89 chloride, Strontium-89. Arm II: Radiotherapy. Involved-field irradiation (equipment unspecified).

PROJECTED ACCRUAL: 200 patients will be entered over 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven carcinoma of the prostate that has relapsed subsequent to chemical or surgical castration and/or antiandrogen therapy Painful, unirradiated osseous metastasis required Documentation by bone scan and x-ray required Number and extent of metastases determined according to Soloway and fitting grades 1-3 Prior hormonal therapy must have lasted at least 3 months and must be continued until completion of this study No imminent paraplegia related to metastases No uncorrectable urinary incontinence

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Hematopoietic: WBC greater than 3,500 Platelets greater than 150,000 Hepatic: Not specified Renal: Creatinine no greater than 2.2 mg/dl (200 micromoles/liter) Other: No calcium supplementation No second malignancy except basal cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No restriction Endocrine therapy: Prior and concurrent hormonal therapy required Radiotherapy: No prior strontium-89 No prior hemibody or total-body irradiation Prior local-field irradiation for bone metastases allowed provided new site of painful metastases exists Surgery: Surgical castration allowed
Newcastle Low Back Pain Intervention Study

The aim of this study is to investigate if six-weeks of exercise intervention, 3 times per week on the Functional Re-adaptive Exercise Device (FRED) reduces non-specific mechanical low back pain in adults ages 18-60.

The aim of this study is to investigate whether an six-week FRED exercise intervention reduces low back pain (LBP) and improves a range of related outcomes.

The objectives of this study are to examine

1. whether FRED exercise reduces mechanical LBP ( low back pain);
2. whether FRED exercise improves functional and static balance in people with LBP;
3. whether FRED exercise has an effect on cross-sectional area (CSA) of relevant lumbo-pelvic muscles;
4. whether FRED exercise has an effect on TrA (Transversus Abdominis), LM ( Lumbar Multifidus), lumbar Erector Spinae, External and Internal Oblique muscle activity and function in individuals with LBP;
5. whether FRED exercise has an effect on TrA and internal oblique muscle thickness;
6. the rate of muscle physiology change in response to FRED exercise in people with LBP;
7. whether FRED exercise affects the analgesic intake, need for intervention and physical activity level of individuals with LBP;
8. whether FRED exercise affects wellbeing and every-day function in people with LBP;
9. the rate of change of level of pain, wellbeing and of function (incl. balance) in response to FRED exercise in people with LBP.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical LBP for 8 weeks or longer
* Score of \< 15 on FABQ
* Age 18-60
* Commitment to taking part in the study for its full duration

Exclusion Criteria:

* Presence of "red flags" - indicative of non-mechanical LBP
* Score of \> 15 on FABQ or other indicators of a likely poor response to a solely physical approach to treatment incl. seeking compensation for LBP
* Exercise contraindicated as per Physical Activity Readiness Questionnaire
* Inability to exercise safely on the FRED
* Pregnancy
* Surgery within the previous nine months
* Difficulty to exercise safely in standing for 30 mins 3x/week
* Cardio/respiratory disease
* Neurological disorders
* BMI \> 28 where adipose tissue infringes on ultrasound imaging and intramuscular electrode placement
A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.


Eligibility Criteria:
Inclusion Criteria:

* CLL requiring treatment
* Participants receiving a chemotherapy in combination with rituximab (decision taken by doctor prior to and independent from inclusion in this non-interventional study)
* After this trial started, an amendment to the study protocol was introduced, adding a further inclusion criterion: Comorbidities according to cumulative illness rating scale (CIRS) score greater than (\>) 6 and/or creatinine clearance less than (\<) 70 milliliters per minute (mL/min)

Exclusion Criteria:

* Participants with contraindication to rituximab treatment
Apatinib in Recurrent or Refractory Intracranial Central Nervous System Malignant Tumors

The patient was given a daily dose of apatinib 500mg (or based on weight). Individualized chemotherapy regimens were given based on molecular expression and prior chemotherapy.

The patient was given a daily dose of apatinib 500mg (or based on weight). Individualized chemotherapy regimens were given based on molecular expression and prior chemotherapy. Brain MRI+MRS was examined every 3 months; Blood routine, urine routine and liver and kidney function were examined once a week.

Eligibility Criteria:
Inclusion Criteria:

* (1) 18 years \< the age of patients \> 70 years. (2) Karnofsky performance scale (KPS) ≥ 60. (2) Histologically confirmed diagnosis of GBM World Health Organization \[WHO\] Grade IV. (3) They were required to have measurable or evaluable disease by magnetic resonance imaging (MRI) confirmation and a minimum life expectancy of 8 weeks. (4) Definition of relapse: all patients must have progressive disease on MRI defined by Response Assessment in Neuro-Oncology (RANO) criteria after the standard Stupp protocol. The time interval for the start of treatment was at least 12 weeks from prior radiotherapy unless there was either histopathologic confirmation of recurrent tumor or new contrast enhancement on MRI outside of the radiotherapy treatment field. (5) Adequate bone marrow function (leukocyte count ≥ 4000/μL, neutrophil count ≥1500/µL, platelet count ≥100 000/µL, hemoglobin ≥8.0g/dL), adequate renal function (serum creatinine ≤ 150μmol/L, 24 hours urine protein ≤3.4g), and liver function (total bilirubin ≤34μmol/L and aspartate and alanine aminotransferase ≤120U/L).

Exclusion Criteria:

* (1) extracranial metastatic disease, (2) Gliadel wafer treatment, (3) severe cardiopulmonary insufficiency, (4) status epilepticus, (5) pregnancy, (6) gastrointestinal bleeding, (7) uncontrolled blood pressure with medication (\>140/90 mm Hg), (8) swallowing difficulties. (9) HIV positivity with a combination antiretroviral therapy.