cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)

In this study, we aim to analyse the effect of phosphate supplementation on donors undergoing partial hepatectomy for LDLT. In Group A, we are going to supplement phosphate in donors postoperatively from day 1 to day 5. We will analyse the trend of serum phosphate levels in donors postoperatively, its correlation with occurrence of postoperative complications and status of liver regeneration by CT volumetry on Day 7. Group B will constitute the controls for the study and hence attempt to find out the effect of phosphate supplementation in all donors postoperatively. We will analyse the data and elucidate the value of phosphate supplementation in reducing the occurrence of complications and effect on liver regeneration in donors in LDLT.


Eligibility Criteria:
Inclusion Criteria:

* All donors evaluated as per institutional protocol for donor hepatectomy and found fit
* Those who consent.

Exclusion Criteria:

* Patients refusing to consent for inclusion in the study.
* Minor hepatectomy
* Those who develop profound hypophosphatemia in the control group
Osteosarcoma Study #2: A Randomized Trial of Pre-Surgical Chemotherapy vs. Immediate Surgery and Adjuvant Chemotherapy in the Treatment of Non-Metastatic Osteosarcoma. A Pediatric Oncology Group Phase III Study

The study is designed to determine if the administration of multi-drug adjuvant chemotherapy for patients with primary non-metastatic osteogenic sarcoma, both prior to and after the definitive surgical procedure for their primary tumor is superior as a treatment strategy to the current approach of giving drugs only after the definitive surgical procedure has been performed. An effort will be made as well to determine if the administration of pre-definitive surgery, chemotherapy leads to an increase in the proportion of the patients suitable for a limb salvage primary surgical procedure.

The study is designed to determine if the administration of multi-drug adjuvant chemotherapy for patients with primary non-metastatic osteogenic sarcoma, both prior to and after the definitive surgical procedure for their primary tumor is superior as a treatment strategy to the current approach of giving drugs only after the definitive surgical procedure has been performed. An effort will be made as well to determine if the administration of pre-definitive surgery, chemotherapy leads to an increase in the proportion of the patients suitable for a limb salvage primary surgical procedure.

Eligibility Criteria:
Must be less than or equal to 30 years of age.

No prior history of cancer.

No prior therapy-other than biopsy.

Informed consent according or institutional guidelines (Agreement to randomization to either presurgical chemotherapy or immediate surgery-physicians must also agree).

Less than or equal to 21 days since initial diagnosis and eligible to have surgery within 3 weeks of randomization.

Must have a high grade osteosarcoma.

Must not have low grade osteosarcoma, periosteal and parosteal

osteosarcoma, or multi-focal sclerosing of osteosarcoma.

Tumor must be confined to extremity or expendable and resectable bone of axial skeleton (i.e., ilium, scapula, clavicle, rib).

No evidence of metastases by PE, CXR, chest CT, and bone scans. (Chest CT must be normal within 2 weeks of randomization). Abnormalities on chest CT must be biopsy-negative or thoracotomy negative. Suspicious lesions on bone scan should be biopsied.

LDH level and surgical intent (i.e., amputation, resection, or limb replacement) must be known before patient is registered.
Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study

This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence

The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk.

PRIMARY OBJECTIVE:

To evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.

SECONDARY OBJECTIVE:

Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy.

EXPLORATORY OBJECTIVE:

Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C and/or RAD51D gene germline mutation.
2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D
3. Childbearing completed or no longer requires fallopian tubes
4. Presence of at least one fallopian tube
5. Participants may have a personal history of non-ovarian malignancy.
6. Informed consent must be obtained and documented.

Exclusion Criteria:

1. Postmenopausal status (natural menopause or due to (cancer) treatment)
2. Wish for second stage RRO within two years after RRS (if clear at enrollment)
3. Legally incapable
4. Prior bilateral salpingectomy
5. A personal history of ovarian, fallopian tube or peritoneal cancer
6. Current clinicals signs, diagnosis or treatment for malignant disease
Motivational Interviewing and Addiction

The increasing use of the internet makes understanding games among adolescents different by moving it to the virtual environment and increases the digital game addiction risk. Especially among adolescents, digital games have become a popular activity and often a means of socialization. With the widespread use of smartphones, digital gaming has transformed from computer and console-based to a multi-platform activit. In addition, long-term digital games cause symptoms such as anxiety and depression through increased interpersonal loneliness and decreased relationships. This situation has caused recent research to focus on the effects of digital gaming activities on individuals.

Internet addiction and digital game addiction, which are the negative side of rapidly developing digital technologies and increasing internet accessibility, are of global concern. Therefore, implementing interventions for internet and digital game addiction can be an effective approach to prevent physical, mental, environmental, and social problems caused by addiction. In this context, it is predicted that motivational interviewing may be an appropriate approach in combating internet and digital game addiction. Motivational interviewing is a client-centered psychotherapeutic approach that helps the person with ambivalence make positive decisions, achieve specific and better goals, and increase internal motivation for change. It is thought that motivational interviewing could contribute to reducing addictive behaviors by evaluating the effect of motivational interviewing on both internet addiction and digital game addiction at the same time.

Eligibility Criteria:
Inclusion Criteria:

* Being a ninth-grade student
* Being in the intention or pre-intention stage according the change assessment form
* Being addicted to digital games
* Having family approval
* Volunteering to participate in the research

Exclusion Criteria:

• Having any physical and mental illness
Biomarkers for Early Screening of Gestational Diabetes Mellitus

Gestational Diabetes Mellitus (GDM) refers to the abnormal glucose metabolism first detected during pregnancy. It is estimated that approximately 7% of pregnant women worldwide and their offspring are affected by GDM. The incidence of GDM in China is as high as 18.9%. A number of studies have shown that GDM complicates 3%-25% of pregnancies and poses serious health and life threats to the mother and child. In fact, due to the lack of physical activity during pregnancy and the decrease of insulin sensitivity compared with non-pregnancy, the optimal time for intervention has long been lost until the diagnosis of GDM in the second trimester. However, it is a pity that no authoritative screening method for GDM in early pregnancy has been established, and the pathogenesis of GDM is still unclear. This study intend to search for biomarkers used for screening of GDM in early pregnancy and explore the pathogenesis of GDM, so as to provide new ideas for prevention measures and treatment targets of GDM.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age: 20-49 years
* Plan to have routine prenatal examinations and give birth in the research center
* Willing to cooperate with the hospital to follow up

Exclusion Criteria:

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases, autoimmune diseases, malignant tumors, AIDS, etc.
* Fetus has a known deformity or genetic defects
* Incomplete clinical data
Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh

Investigator is studying the effects of Lidocaine and Adrenaline Soaked Gauze vs Normal Saline Soaked Gauze at Skin Graft Donor Site of Thigh.

Haemostatic effect, epithelization and post operative pain will be assessed on follow up.

After admission participants will be randomized either to be in Group A or Group B. Closed envelop technique will be used for random assignment of the patients.

Group A will be receiving 2% lidocaine and 1:100,000 adrenaline soaked gauze while group B will be given only normal saline soaked gauze at donor-site for ten minutes.

The primary end point of study is intraoperative bleeding. The secondary end points of study include no. of dressings required in first 24 hours after surgery, donor site epithelization at 14th post-operative day, post-operative pain in first 24 hours after surgery along with systemic analgesia requirement after surgery.

Eligibility Criteria:
Inclusion Criteria:

* • Patients of both the gender of age \> 15 years

  * Multiple donor-sites

Exclusion Criteria:

Bleeding disorder

* Concomitant injuries
* Donor site other than thigh
* Previously harvested donor-site
* Patients on antiplatelet medications
Development of a New Immunochemistry Method Using Antibodies of Proteins Related Bile Duct Cancer

The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to develop a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer related protein expressed only in bile duct cancer.

Hypothesis: The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method.

Clinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by new staining method and compare with the results of conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography)
* Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy
* Patients who underwent surgical treatment with biliary cancer
* Patients with bile duct stenosis

Exclusion Criteria:

* Minors under the age of 19, vulnerable subjects such as illiteracy
* Necrotic specimens
* Samples with non-diagnostic cytology results and insufficient cells for further evaluation
* Samples classified as neoplastic (benign or other)
* Patient with cholangitis in the bile duct
Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.

The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared to placebo improves ADHD symptoms and is well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of ADHD
* Patient understands and is willing to comply with all study requirements
* Adults between the ages of 18-65 inclusive

Exclusion Criteria:

* Current psychiatric disorder other than ADHD
* Previous randomization into this study
* Women with a positive pregnancy test
Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer

Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed for its complicated anatomy. But laparoscopic distal pancreatectomy (LDP) has been widely accepted as a standard treatment for body and tail pancreatic cancer because there is no anastomosis in it, and LDP has gradually become the first choice for these cancers in clinical work. Although there are several studies about the comparison between LDP and ODP, most are retrospective and there is no agreement in surgical margin, lymph node numbers and prognosis to identify the oncological differences between the two surgical approaches. The investigators' pilot study showed that patients with body and tail pancreatic cancer underwent LDP had a better prognosis compared with the ones undergoing ODP, with no statistics differences in postoperative complications and mortality. This perspective RCT study is performed to confirm whether LDP would improve the prognosis for patients with body and tail pancreatic cancer compared with ODP.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 19 years and ≤ 80 years, no gender limitation
2. Resectable body and tail pancreatic cancer (refer to NCCN 2018)
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Tumor locates at the body and tail of the pancreas without distant metastasis
5. No celiac trunk and superior mesenteric artery invasion
6. No operation contraindication, fit for laparoscopic surgery
7. The expected survival after surgery ≥ 3 months
8. Patients who are willing and able to comply with the study procedure
9. Signed informed content obtained prior to treatment

Exclusion Criteria:

1. Locally advanced unresectable body and tail pancreatic cancer
2. Multi-organ and vascular resection needed
3. Patients undergoing total pancreatectomy
4. Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas
5. Distant metastasis or ascites detected by imaging
6. Severe important organ function impairment (heart, liver, kidney)
7. Patients who are with other primary malignancy or haematological disorders
8. Pregnant or nursing women
9. Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy
10. Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months
Mandibular Overdenture Retained by 1 or 2 Implants: a Cost-effectiveness Analysis

The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants, based on a randomized clinical trial.

This randomized clinical trial alongside a cost-effectiveness analysis will include 48 edentulous individuals who meet eligibility criteria. New maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. Then, participants will be randomized into one of the treatment groups: mandibular overdenture retained by two implants group or single-implant mandibular overdenture group. Each participant allocated to the single-implant mandibular overdenture group will then receive a Straumann® Standard Plus SLActive® regular neck implant (Straumann 0.33.051S/052S/053S Institute Straumann AG, Basel, Switzerland) in the mandibular midline, and the mandibular overdenture retained by two implants group will receive two implants of the same specification, in the interphoramen region. A healing abutment will be connected and the implant will be allowed to heal for approximately 3 weeks. Then, a 3.4mm retentive titanium anchor abutment (Straumann 048.439, Institute Straumann AG, Basel, Switzerland) will be connected and tightened to 35 N.cm with a torque wrench. The matrix will be incorporated to the denture using self-curing acrylic resin and the patient will be instructed to keep the upper and lower dentures firmly occluded in the habitual position until the final polymerization of the resin. Outcomes (satisfaction with the dentures and oral health-related quality of life) will be measured at baseline and at the 6- and 12-month follow-up. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.

Eligibility Criteria:
Inclusion Criteria:

* No contraindications for implant surgery (mainly related to uncontrolled systemic diseases)
* Present enough bone volume in the mandibular midline area for implant placement without the need of bone augmentation procedures.
* Be able to understand and answer the questionnaires used in the study
* Agree to participate by providing a written informed consent.

Exclusion Criteria:

* Noncompliant participants
* Individuals who do not agree to be randomly allocated to the treatment study group
* Presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments
Dietary Advanced Glycation End-products and Insulin Resistance in Overweight and Obese Humans

We hypothesize that reduction in dietary advance glycation endproducts (AGE) intake will increase insulin sensitivity and normalise insulin secretion in overweight and obese individuals through reduction of chronic low grade inflammation.

We propose to test this hypothesis by performing euglycemic hypeinsulinemic glucose clamp and intravenous glucose tolerance test before and after low AGE diet and normal Australian diet in a cross-over design. This study will provide information relevant to the development and prevention of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* weight stable overweight and obese (BMI ≥ 25kg/m2) non-diabetic individuals, aged 18-50 years and healthy according to medical history, blood biochemistry and physical examination.

Exclusion Criteria:

* Participants will be excluded if they:

  * are aged \<18 years or \> 50 years;
  * currently smoke, have high alcohol use; or a positive urine drug screening test;
  * have a history of: diabetes, cardiovascular and hematological disease, respiratory, gastrointestinal, endocrine, renal or central nervous system disease, psychosis or psychiatric disorder, active cancer within last 5 years.
  * are actively seeking to lose weight, or if their weight has changed by more than 10 kilograms in the previous 12 months.
  * have been taking medication within one month prior to commencing the study;
  * have acute inflammation (by history, physical or laboratory examination)
  * are on hormonal contraceptives, or pregnant (by HCG urine pregnancy screening test) or lactating
  * have highly unusual dietary habits or follow vegan diets (because of the difficulty in complying with the assigned diet).
  * have current diabetes (determined by history and/or 75g glucose OGTT)
  * are unable to provide informed consent
Modifying Exercise for the COPD Patient

This study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve participation in a pulmonary rehab program compared to the Nustep elliptical. The main outcome of participation will be measured by the number of exercise sessions the patient is able to complete during their pulmonary rehabilitation program. In addition, distance walked in six minutes, dyspnea score, rate of perceived exertion (RPE) score, Pain Scale Index score, and finally, the Dartmouth Quality of Life index (DQL) will be assessed in both groups. It is believed that the new machine will provide better overall outcomes compared to the traditional machine.

A Prospective cohort study of 25 COPD patients with osteoarthritis undergoing an exercise plan in a pulmonary rehab program. Patient pain level, clinical outcomes, and ultimately, quality of life outcomes will be assessed in order to assess whether future compliance for COPD arthritic patients will occur in an exercise rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* COPD Patient
* Osteoarthritic limitations in upper or lower extremities, or spine
* Forced Expiratory Volume (FEV)1 less than 70%
* Forced Expiratory Volume/Forced Vital Capacity (FEV/FVC) ratio less than 70%

Exclusion Criteria:

* Patients with rheumatoid arthritis
Prevention of Lateral Epicondylalgia in Handgun Olympic Shooting Athletes

Lateral epicondylalgia is one of the most common pathologies suffered by Olympic gun shooting athletes. In Spain, there is hardly any research carried out in this sport, so there are no injury prevention protocols available. Preventing these injuries would be fundamental to improve the performance of athletes and to be able to continue adding successes to national honors.

It has also been evidenced that if exercise is combined with stretching, the benefits of physical therapy are increased. High-quality studies have stated that it is not necessary for this exercise protocol combined with stretching to be very prolonged over time, as they affirm that significant improvements can be achieved with only four weeks of exercise.

This study aimed to test the hypothesis that Olympic handgun shooting athletes who perform a four-week multimodal exercise program combined with stretching have a lower risk of suffering from lateral epicondylalgia than athletes who do not perform this program, determining its effectiveness for pain prevention.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged \>35 years
* Present a risk of suffering from lateral epicondylalgia
* Be in possession of a federation Olympic shooting license
* Practice Olympic shooting with handgun and carry out at least one Olympic shooting training session a week or have participated in the last three months in an official competition

Exclusion Criteria:

* Subjects who had serious uncontrolled illnesses
* Who had undergone surgery as a treatment for lateral epicondylalgia
* Who had received treatment for lateral epicondylalgia in the last month or injections of corticosteroids or steroids for this pathology in the last 6 months
* Who had suffered a serious upper limb injury in the last year or present a risk of suffering epicondylalgia due to a cause other than Olympic shooting