cyrilzakka/clinical-trials huggingface dataset:
Changes in Ingestive Behaviour Following Gastric Bypass

The gastric bypass procedure is known to be one of the most successful treatments for morbid obesity and Type 2 diabetes mellitus, and has been shown to decrease appetite, energy intake, body weight and glycemia both in the short and long term. A number of reports hypothesise that these changes may be driven, at least in part, by positive shifts in food preferences following surgery. However, findings are drawn from self-reported dietary intakes which are beset with measurement bias, thus precluding definite conclusions.

The current work aims to directly observe food intake to test the hypothesis that after gastric bypass food intake changes in a manner which leads to beneficial outcomes on body weight when compared to weight stable control participants. Patients (n=32) with a planned gastric bypass procedure will be recruited from Phoenix Health (Ireland and England) and Letterkenny University Hospital (Ireland), alongside control participants (n=32) with no planned weight loss. All subjects will attend the Human Intervention Studies Unit (HISU), Ulster University on five occasions (1-month pre-surgery and 3, 12, 24 and 60 months post-surgery, with controls being time-matched). Study visits will be fully residential involving two overnight stays within the facility during which participants' 24-hour food intake will be covertly measured (7am-11pm Day 2 and breakfast Day 3) and the following procedures undertaken; basal metabolic rate, body composition, bone health, assessment of liking/wanting high fat foods and post-meal gut hormone responses. On each study visit participants will have ad lib access to a range of foods of varying macronutrient composition and which are compatible with their stated food preferences (assessed prior to the start of the study). Changes in all ingestive behaviours will be evaluated over time as compared to the control participants.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Planned gastric bypass surgery (patients only)
* No planned weight loss/gain (controls only)

Exclusion Criteria:

Patients

* Significant dysphagia, gastric outlet obstruction or any other factor which prevents consumption of a meal
* Systemic or gastrointestinal condition which may affect food intake or preference
* Pregnancy / lactation
* Significant food allergy or dietary restriction
* Medication with documented effect on food intake or food preference
* Any other physical or psychological condition which would affect the outcome of the study as determined by Phoenix Health care team.

Controls

* Medication with documented effect on food intake / preference or study outcomes
* Pregnancy / lactation
* Significant food allergy or dietary restriction
* Undertaking a weight-loss programme or planning to.
Genetic Regulators of Bone Health That Are Unique to Vertebral Bone

Osteoporosis is an age related disease in which a person's bone slowly becomes weaker with time. The bones may become so weak that they break easily such as a fall from standing height. The most commonly broke bones in osteoporosis are those of the hip, the spine or the wrist. Osteoporosis runs in families meaning that genetic differences explain why some people break bones in old age and other do not. Genetic studies have been done that show the the genes associated with spine (vertebral) fractures (broken bones) and hip fractures are different, suggesting that osteoporosis of the spine is not the exact same disease as osteoporosis of the hip. Genetic studies tell us what part of the genome (i.e. genes) are associated with a disease, but do not tell us how these genes act biologically to cause that disease. In this study, we seek to determine how the genes uniquely associated with spine osteoporosis behave in normal and aged bone, to determine how they interact with each other as a team to impact spine bone. In this study, we will measure gene activity (so called gene expression) in bone samples taken from people undergoing major spine deformity surgery. We will using genetic data from these patients to determine how gene activity is controlled in bone and how that relates to measures of bone health such as bone mineral density data. The results of this study will provide critical data regarding how osteoporosis of the spine happens, and these data will be used to find better and safer treatments to prevent bone fractures of the spine that happen with age.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18 and 85 undergoing a multi-level spinal fusion (i.e. a T10 (or higher) fusion to the pelvis) -OR- a 3 column osteotomy with a corpectomy from for short segment surgeries -OR- a vertebral column resection (VCR) involving a corpectomy -OR- any deformity correction surgery wherein the attending surgeon determines that a large amount of bone containing trabecular elements will be removed and discarded.
* Willing and able to provide informed consent

Exclusion Criteria:

* End stage renal disease.
* Any history of cancer.
* Reliance on a wheelchair for 70% or greater of their mobility for longer than 12 months.
* Quadra or paraplegia due to spinal cord injury.
* Current use of epilepsy medications.
* Confirmed Marfans, osteogenesis imperfecta or other genetic syndrome known to impact bone formation (Guacher's, Vit D independent rickets, etc).
* Current glucocorticoid use lasting longer than 3 months, or greater than 6 months lifetime use.
* Current or suspected current infection associated with orthopedic hardware.
* HIV or Hep C positive and or currently on anti-viral medications.
* History of gastric bypass surgery and or weigh loss exceeding 100 pounds.
* Primary or secondary hyperparathyroidism.
* Paget's disease
Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance

Comparing the effect of HBOT and IHT on aerobic performance of athletes.

Enhanced physical performance is the goal of all professional and non-professional athletes. There are many intervention methods aim to enhance physical performance from 2 intervention related to change in the environment partial oxygen pressure have been demonstrated to have beneficial effect: IHT and HBOT.

This study offers one of the two interventions to athletes with a pre and post intervention objective evaluation of the physiological performance - Maximal exercise test for evaluating VO2MAX and ventilatory thresholds, time to exhaustion, 30 seconds Wingate test, agility test, muscle biopsy, blood tests, brain MRI, cognitive tests and exercise cognitive test.

After signing an informed consent form, eligible subjects will be randomized to one of the study groups at a ratio of 1:1. The IHT group will receive three hypoxic guided training sessions per week, according an individualized training protocol, 24 sessions in total.

The HBOT group will receive 40 daily hyperbaric sessions, five days per week. Each session will include 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Three times per week, as the IHT group, the HBOT group will have a guided training session, according an individualized training protocol.

Both groups, IHT and HBOT, will have the same relative intensity guided training protocols for 8 weeks, to stimulate the same exercise load. The IHT group will train for 60 minutes, 3 times a week in a normobaric hypoxia environment, at O2 concentration of 15.2% that stimulates a 2500-2600m height. The HBOT group will train for 60 minutes after the HBOT sessions, 3 times per week, in a normobaric normoxic environment

Physical performance evaluations will be conducted on 3 different times post interventions - a day last intervention, 3 weeks after and 2 months after - in order to analyze the long term effect of each intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Vo2max above 3500 ml or Vo2max/kg above 50 ml/kg
2. Age 18-45
3. Subjects are active aerobic athletes, training regularly more than 4 exercise sessions per week.
4. Subject willing and able to read, understand and sign an informed consent

Exclusion Criteria:

1. Inability to attend scheduled clinic visits and/or comply with the study protocol
2. Active malignancy
3. Active smokers
4. Previous treatment of HBOT for any reason prior to study enrollment.
5. Chest pathology incompatible with pressure changes
6. Major orthopedic injury at the past 3 months
7. Inner ear disease
8. Lung pathology
9. The inability to perform an awake brain MRI
10. Claustrophobia
11. Previous neurologic conditions (e.g., Epilepsy, Brain tumors or s/p neurosurgery etc.)
12. Comorbidities and medications that rule out the subject
Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.

OBJECTIVES:

Primary

* To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
* To determine safety
* To determine overall survival
* To determine time to progression

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* At most one prior chemotherapy regimen for unresectable or metastatic disease. Any adjuvant chemotherapy must have been completed more than 12 months prior to beginning protocol therapy
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* At least one measurable lesion according to RECIST criteria that has not been irradiated
* Adequate laboratory parameters as outlined in protocol
* Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely, given the drug-drug interaction between coumadin and capecitabine
* Negative serum pregnancy test within 14 days prior to registration

Exclusion Criteria:

* Pregnant or lactating women
* Life expectancy \< 3 months
* Serious, uncontrolled, concurrent infection(s)
* Any prior oxaliplatin or fluoropyrimidine therapy
* More than one prior chemotherapy regimen for unresectable or metastatic disease
* Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or platinum compounds
* Any active second malignancy
* Clinically significant cardiac disease or myocardial infarction within the last 12 months
* Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability
* Other serious uncontrolled medical conditions
* Major surgery within 4 weeks of the start of study treatment, without complete recovery
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
* Known, existing uncontrolled coagulopathy
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* age between 19 and 55 years
* relapsing course of multiple sclerosis (relapsing-remitting or secondary progressive MS with relapses
* duration of the disease of at least 1 year
* no disease modifying therapy or unchanged immunomodulatory therapy for the last 3 months
* at least 2 documented relapses during the last 24 months with the last relapse within the last 12 months

Exclusion Criteria:

* pregnancy or period of breastfeeding or missing adequate contraceptive protection for female premenopausal patients
* relapse in the last month prior enrolment
* treatment with steroids in the last 30 days
* previous treatment with mitoxantroneduring the last year
* previous treatment with cyclophosphamide or other intensive immunosuppression, total irradiation
* treatment with glatiramer acetate, azathioprine, IVIG or any other immunosuppressive or immunomodulatory drug apart from interferon-beta in the 6 months prior to enrolment
* cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension
* diabetes mellitus and other autoimmune diseases
* history of renal insufficiency
* stay in tropical areas during the last 3 months
* eosinophilia in the blood (\> 0,45 billion/l)
* concurrent systemic infections
ROCO - Self-help for People With Psychological Distress Due to the Covid-19 Situation

As part of the ROCO project, the University of Bern is investigating an online self-help program for people who are psychologically distressed due to the situation surrounding Covid-19. The ROCO program offers support in overcoming this psychological distress. ROCO stands for a 3-week online self-help program comprising 6 modules.

The aim of the study is to investigate the efficacy of an online self-help intervention for people with psychological distress due to the situation surrounding Covid-19. All participants will be randomized to one of two groups: The first group receives direct access to the online self-help intervention and the second group is a waiting control group that receives access to the program 3 weeks later. In both conditions additional care or treatment is allowed.

There are 4 assessments, which all take place online: baseline, post assessment (after 3 weeks) and two follow-up assessments (after 6 and 18 weeks). All participants from both groups are asked to fill out all assessments.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Give a declaration of consent to participate in the study
* Have access to the internet
* Understand and master the German language to the degree that they understand the contents and instructions of the study
* Exceed a cut-off value of 4 points on the Brief Patient Health Questionnaire (PHQ-9; Löwe, Spitzer, Zipfel, \& Herzog, 2002)
* Be able to specify an emergency address in the event of an acute crisis

Exclusion Criteria:

* Suicidal tendencies (SBQ-R Score ≥ 8)
* Existence of a known diagnosis of a psychotic or bipolar disorder
Patterns of Neurodevelopmental Disorders

The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.

Although neurodevelopmental disorders are very prevalent (for example Autism affects 1 out of every 36 children and dyslexia affects up to 15% of the population), the etiology of such disorders is not known. The purpose of this investigation is to identify common etiologies of neurodevelopmental disorders (i.e., speech delay, global developmental delay, autism) and determine if it is possible to find early indicators of the diagnosis and foster the potential for a better prognosis of these disorders. At this time the investigators examine patients with neurodevelopment disorders with various medical investigations, but the results of these investigations are not systematically evaluated. One of the goals of this research is to systematically examine this information in order to identify patterns of test abnormalities that have not been previously described. Another goal of this research is to identify the common etiologies typically identified by the medical evaluation, so we can further refine our approach. In addition, the investigators now have the ability to evaluate biological samples for biomarkers that have potential to be diagnostically useful.

Eligibility Criteria:
Inclusion Criteria:

Neurodevelopmental delays Clinical visit at an Rossignol Medical Center

Exclusion Criteria:

-
Study Comparing the Role of the Laparoscopy Surgical Staging in the Peritoneal Carcinomatosis to Laparotomic Approach

The peritoneum is the second most common site of recurrence in patients with colorectal cancer. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy improve the prognosis of these patients and incorporates surgical removal of all visible disease followed by chemical destruction of microscopic disease through chemoperfusion. The most validated predictors of outcome are preoperative tumor burden measured in terms of the peritoneal carcinomatosis index (PCI) and completeness of cytoreduction (CC score). Diagnostic laparoscopy prior to resection is widely used in hepatopancreaticobiliary and colorectal cancer and has been shown to be effective in excluding unnecessary laparotomy associated with higher morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Colorectal cancer with a resected minimal synchronous peritoneal carcinomatosis, or ovarian metastases, tumour rupture in the abdominal cavity.
* Patients received six months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified)

Exclusion Criteria:

* None
Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .

A Cochrane review of prospective randomized trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF ET outcomes in patients with hydrosalpinges. Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity and previous multiple laparotomies. Other less invasive options for patients with hydrosalpinges as ultrasound guided aspiration of hydrosalpingeal fluid, antibiotics and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy. Although these methods are simple and getting popular,current data are inadequate to recommend these treatment options instead of salpingectomy. The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral or bilateral hydrosalpinges visible by ultrasound
* Age between 18 - 37 years
* Period of infertility \> 1 year
* Body mass index between 19-29
* Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations
* Normal recent semen analysis (according to World Health Organization criteria)

Exclusion Criteria:

* Uterine fibroid requiring surgical removal
* Endometriosis
* Male factor of infertility requiring ICSI
* Previous IVF cycles
* History of recurrent miscarriage
* Endocrinologic disorders
* Presence of systemic disease contraindicating pregnancy
RituxiMab INDuction in Renal Transplantation

Hypothesis:

* That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival.

Aim:

* To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration.

Objectives:

* To assess whether B cell depletion affects graft function, acute rejection and complication rates
* To assess whether the T cell response to allotransplantation is impaired by B cell depletion.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
* Patients who have given written informed consent
* Women of child bearing potential taking adequate contraception.

Exclusion Criteria:

* Previous other organ transplants lost through acute rejection
* Patients undergoing antibody incompatible transplantation
* Patients with other organ transplants
* Patients previously treated with cyclophosphamide, ATG, OKT3 or rituximab
* Patients with white cell count below 4.0x10\^9/L.
* Patients with platelet count below 100x10\^9/L
* Patients who are treated with drugs that are strong inhibitors or inducers of cytochrome P450, or treated with terfenadine, astemizole, cisapride or lovastatin
* Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant
* Pregnant or breastfeeding women
* Patients with a documented history of malignancy and its origins and treatment in the last five years. (Localised basal cell carcinoma of the skin is permitted)
* Patients known to be HIV, Hepatitis B surface antigen or Hepatitis C antibody positive
* Patients who in the opinion of the Investigator would not be a suitable candidate for study participation
* Women of child bearing potential not willing to take adequate contraception
Dynamic Taping in Symptomatic Rotator Cuff Tendinopathy

This study was conducted to compare the efficacy of two different therapeutic bands in symptomatic rotator cuff tendinopathy. One of the tapes was kinesio tape and the other was dynamic tape. The study was in a parallel group randomized controlled trial design.

This study was planned to compare the effectiveness of dynamic taping and kinesio taping combined with a rehabilitation program on the symptomatic shoulder in patients with symptomatic rotator cuff tendinopathy (RCT). The study was carried out on 60 patients who applied to Muğla Training and Research Hospital Physical Therapy and Rehabilitation outpatient clinic with symptoms of RCT. The patients were divided into 3 groups by randomization method. Dynamic taping was applied to the symptomatic shoulder in the first group and kinesio taping was performed in the second group. The third group was the control group and no taping was done. A standard rehabilitation program was applied for the individuals in the whole group. Evaluations were made before and after treatment (6 weeks). Evaluation parameters were acromiohumeral distance (primary outcome), shoulder joint range of motion, muscle strength, proprioception measurements, and function evaluations. The acromiohumeral distance was measured by the radiologist, and all other measurements and treatments were performed by the physiotherapist. Standard goniometer was used for shoulder joint range of motion measurement, manual muscle dynamometer was used for muscle strength measurement, and digital inclinometer was used for proprioception measurement. Timed arm-shoulder function test was performed for function evaluation. The arm, shoulder, and hand disability (DASH) questionnaire and the Western Ontario Rotator Cuff Index (WORC) were used for the self-function report. The data obtained from the research will be analyzed using the SPSS program. Statistical significance level will be accepted as p\<0.05. In the statistical difference analysis between groups, one-way ANOVA test will be used for parametric data and Kruskal-Wallis test will be used for non-parametric data.

Eligibility Criteria:
Inclusion Criteria:

* Those with a diagnosis of RCT
* Those with subacromial pain
* At least two of the three impingement tests are positive (empty-can test, Hawkins-Kennedy test, modified Neer test)
* 18-65 years old

Exclusion Criteria:

* Those with open wounds at the taping area
* Those who have allergic reactions to taping
* Those who have had shoulder surgery before
* Those with total rotator cuff tendon rupture
* Those with a history of fractures in the upper extremity or glenohumeral joint subluxation -- Presence of adhesive capsulitis (those with more than passive shoulder joint motion loss 70%)
* Presence of congenital or acquired deformity involving the upper extremity
* Those with rheumatic or neurologic disease
* Those with cervical radiculopathy
* Those with a history of neoplasm or cognitive impairment (MMSE\<24)
* Those who received corticosteroid injection to the shoulder region in the last 3 months
* Those who received physiotherapy treatment in the last 3 months