cyrilzakka/clinical-trials huggingface dataset:
Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy

This was a randomized unblinded single-centre trial. The main hypothesis of the study was that pylorus-preserving pancreatoduodenectomy reduces the incidence of delayed gastric emptying . Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of surgical technique: pylorus-preserving pancreatoduodenectomy versus stardard pancreatoduodenectomy with antrectomy. The primary endpoint was the incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative morbidity and mortality, length of hospital stay, and nutritional status and quality of life.

This was a randomized unblinded single-centre trial without masked evaluation of the main outcome.The authors decided to compare pancreatoduodenectomy with antrectomy versus pancreatoduodenectomy with pyloric preservation. The primary aim of this randomized clinical trial was to determine whether pancreatoduodenectomy with pyloric preservation is associated with a lower incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative complications, postoperative mortality and duration of hospital stay. Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of gastroenteric anastomosis for reconstruction. Analytical parameters such as C-reactive protein, prealbumin, and albumin; as well as anthropometric measures (mean) as preoperative arm circumference mean and tricipital skinfold mean were registered preoperatively, at 5th week, and at 6th mounth. Scintigraphic study had performed following a specific protocol for gastric emptying. At the end, quality of life was also analized with a quality of life questionnaire (QLPAN26) preoperativelly and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent surgical resection of the head of the pancreas at the authors' institution from August 2003 to August 2008. Adults of either sex aged over 18 years were included.

Exclusion Criteria:

* Associated resections of other organs, except for the portal or superior mesenteric vein
* Total pancreatectomy
* Previous gastrectomy or other gastric surgeries
* Neoadjuvant treatment
* Liver cirrhosis.
Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).

The purpose of this study is to:

1) to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6 months after randomization, to the respective treatment arms to determine the differences between the 2 treatment modalities.

Eligibility Criteria:
Inclusion Criteria:

* Age 10 - 20 years
* Pubertal level of Tanner stage III-V and menarchal
* BMI percentile for age and sex greater than or equal to 85%ile

Exclusion Criteria:

* Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
* Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
* Established diagnosis of diabetes
* Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
* Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)
* Vitamin D deficiency (\<10ng/mL)
* Hyperkalemia (K\>5.0 meq/L)
* Positive pregnancy test (serum)
Effect of Intake of Whey Protein in Elderly Osteopenic Patients. Implications for Metabolism and Physical Function.

The aim of this study is to investigate potential metabolic effects of whey protein high in protein and high in leucine(HPHL) compared to soy protein high in protein and low in leucine(HPLL) in osteopenic patients in a randomized controlled intervention study.

The investigator hypothesize that HPHL will increase physical function and the ratio muscle mass / fat mass in this condition.

With an increase in the older population in Denmark and most other countries there is an increase in the rate of patients with age related bone and muscle weakness. Proteins with a high content in ketogenic amino acids e.g. leucine have been investigated in relation to these conditions. Generally acute studies in animals and some in human have been conducted and have demonstrated positive effects in relation to prevention and treatment of bone and muscle weakness. We want to investigate these tendencies with supplementation of proteins in a randomized, blinded, 4 month intervention study with three arms - 1) the control group. 2) soy protein(high protein, low leucine). 3) Whey protein(high protein, high leucine). To increase any possible effect of the supplementation the subjects will complete a resistance training program concurrently. The study will focus on the anabolic properties of the ketogenic amino acids in animal whey protein compared to vegetable soy protein.

The investigator will study changes in:

* Gait speed related to muscle strength
* Walk distance in a Six-minute walk test related to sub maximal physical capacity
* Body composition (LBM/FM ratio) by a DEXA-scanner
* Biochemical markers on bone metabolism
* Bone-mineral-density(BMD) and -content(BMC)(DEXA scans)
* Muscle strength
* Body balance
* Protein and amino acid balance
* Nitrogen balance
* Gene-expression in muscle tissue
* Biochemical markers on fat- sugar- and protein-metabolism
* Biochemical markers on inflammation
* Blood pressure
* Insulin sensitivity by HOMA index
* Estimated maximal physical capacity by a bicycle ergometer test.

The perspective in this study is to develop a nutritional supplement with a high content of ketogenic amino acids (e.g. Leucine) that can be useful and beneficial in treatment and prevention of patients with bone and muscle weakness.

Eligibility Criteria:
Inclusion Criteria:

* Osteopenia defined as BMD T-score \<-1

Exclusion Criteria:

* Vitamin D deficiency defined as 25-hydroxyvitamin D (25-OH-D) below 30 nmol/l.
* Liver and kidney disease.
* Known diabetes or Hgb1c ≥6,5% (≥48mmol/l).
* Severe heart disease (NYHA-Class \>2).
* Oral corticosteroid treatment within the last 3 month.
* Anamnestic information of hip fracture or vertebral fracture.
* Any antiosteoporotic treatment.
* participation in other intervention studies within the last 4 weeks.
Plegridy Satisfaction Study in Participants

The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants' satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants' adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on participants' injection-system satisfaction; Evaluate the relationship between participants' satisfaction and adherence; Evaluate the relationship between participants' satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (annualized relapse rate \[ARR\], disability, etc.) and to evaluate the treatment safety and tolerability.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects diagnosed with Relapsing Remitting MS according to 2010 McDonald criteria.
* Subjects with EDSS score between 0.0 and 5.0 at baseline.

Key Exclusion Criteria:

* Pregnancy or breast-feeding.
* Have any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Effectiveness of Abdomino-pelvic Muscle Contraction Education Programme in Healthy Male University Students

This research study investigates the effectiveness of an educational intervention aimed at improving awareness and control of pelvic floor (PF) and abdominal muscle contractions in healthy young male university students. Using ultrasound imaging, the study measures abdominal wall muscle thickness at rest and during pelvic floor contraction, Active Straight Leg Raise (ASLR) test, and hollowing maneuvers in a randomized control trial.

The study addresses the largely overlooked area of male PF health, aiming to increase awareness and improve muscle control in healthy young men. A two-group design will be used to compare abdominal and PF muscle activation between a control group and an intervention group that receives online educational content. The intervention group will participate in a telematic program covering topics such as PF anatomy, muscle function, and the importance of proper muscle activation.

The study will use diagnostic ultrasound to measure thickness changes in the transverse abdominis (TrA), internal oblique (IO), and external oblique (EO) muscles before and after the intervention in both groups under different conditions: PF rest, PF contraction, single-leg raise (ASLR) test, and the hollowing maneuver.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18-30 years
* Healthy men
* Informed consent submitted, accepted and signed

Exclusion Criteria:

* Patients undergoing abdominal cavity surgery
* Patients with cognitive/proprioceptive impairments
* Patients who have had physiotherapy interventions of PFM
* Patients with low scores on the Spanish-validated SHIM sexual health questionnaire for males.
The Role of Hyperoxia in Acute Ischemic Stroke

This study is being conducted to evaluate the potential therapeutic role of hyperoxia when applied in the immediate ischemic period following a stroke in the controlled Emergency Department setting. The study will evaluate the effects of hyperoxia in stroke patients on the production of markers of free radical damage and inflammatory markers associated with hyperoxic lung injury.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form from patient or legal authorized representative (LAR)
2. Subject or LAR stated willingness to comply with all study procedures and availability for the duration of the study
3. Males and females (of unlikely childbearing capacity) aged over 18 years.
4. Exhibiting signs and physical examination findings suggestive of an acute ischemic infarction (either a or b)

   1. A target mismatch profile of CT-perfusion or MRI determined by RAPID automated software to have a ratio of PWITmax\>6 lesion volume/DWI lesion volume \>1.2 and an NIHSS \>/=1
   2. A RAPID automated software calculated non-contrast CT-head ASPECT score of 10 and LKW ≤12 hours (in patients with symptoms discovered upon waking, the LKW is defined at the midpoint between going to sleep and awakening based on previous studies that suggest most strokes during sleep occur close to awakening)
5. Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen

Exclusion Criteria:

1. Current use of supplemental oxygen
2. Prisoner
3. Documented blood glucose \<70mg/dL
4. Concurrent treatment with another investigational drug or other intervention
5. Documented history of any of the following chronic respiratory illness that require pulmonary vasodilators or supplemental oxygen at baseline: Chronic Obstructive Pulmonary Disorder (COPD), Emphysema, Interstitial Lung Disease, Restrictive Lung Disease, Pulmonary Hypertension
6. Documented history of any of the following autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, primary biliary cholangitis, multiple sclerosis, inflammatory bowel disease
7. Currently being treated for an acute myocardial infarction and/or decompensated heart failure at the onset of initial ED presentation as reported by the ED provider
8. Plans for treatment with either IV tPA (alteplase) or endovascular therapy
A Prospective Study of Outcome After Therapy for Acromegaly

The purpose of this study is to evaluate hormone values and other markers of disease activity in a cohort of patients with acromegaly at the time of diagnosis and then prospectively after surgical or other treatment. This study is designed to determine blood levels of growth hormone and related hormones and cardiovascular risk markers as well as signs and symptoms of the disease at diagnosis and how these parameters change over time after surgical or other therapy. The investigators will also obtain hormonal data in a group of 50 healthy subjects who will each be studied just once with an oral glucose tolerance test (OGTT). These data will provide a comparison group to the acromegaly subjects.

Surgical removal of the pituitary tumor is the usual first form of treatment offered, but this is curative in only approximately 70% of patients. If not adequately treated, the disease can have significant morbidity largely due to the development of hypertension, diabetes and malignancy as well as possible loss of vision or other neurologic complications of a large pituitary mass. Inadequately treated acromegaly is also associated with a mortality rate 2-3 fold over the general population. All the mechanisms responsible for the increased morbidity and mortality in acromegaly as well as what biochemical criteria should be used during treatment in order to normalize the increased morbidity and mortality are not known. This study aims to follow patients with acromegaly prospectively from active disease through treatment in order to identify these factors.

Eligibility Criteria:
Acromegaly Subjects

Inclusion Criteria:

* Adult males and females.
* Ages 18 and over.
* Presenting to the PI or one of the sub-investigators for evaluation of acromegaly.
* Must have a biochemical diagnosis of acromegaly consisting of an elevated serum insulin-like growth factor 1 (IGF-1) level. Supportive although not required for entry are an elevated growth hormone (GH) level and a failure of GH to suppress normally after oral glucose administration.
* Willingness to participate in this study's procedures.

Exclusion Criteria:

* Subjects who are unwilling to comply with the procedures outlined in the study.
* Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures
* Are unwilling to provide informed consent to participate in the study.

Healthy Subjects

Inclusion Criteria:

* Adult males and females.
* Ages 18 and over.
* Responding to ads for participation or by word of mount.
* No medical problems, no medications, stable weight for 3 months prior to study.
* Willingness to participate in this study's procedures.

Exclusion Criteria:

* Subjects who are unwilling to comply with the procedures outlined in the study.
* Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures
* Are unwilling to provide informed consent to participate in the study.
* Failure to meet the inclusion criteria.
A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

Five participants randomized to the docetaxel 100 mg/m\^2 plus placebo group actually received docetaxel 100 mg/m\^2 plus bevacizumab 7.5 mg/kg and are included in the docetaxel 100 mg/m\^2 plus bevacizumab 7.5 mg/kg group for the adverse event results. Sixteen participants randomized to the docetaxel 100 mg/m\^2 plus placebo group actually received docetaxel 100 mg/m\^2 plus bevacizumab 15.0 mg/kg and are included in the docetaxel 100 mg/m\^2 plus bevacizumab 15.0 mg/kg group for the adverse event results.

Eligibility Criteria:
Inclusion criteria:

* Female patients ≥ 18 years of age.
* Human epidermal growth factor receptor 2 (HER2)-negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy.
* No adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion criteria:

* Previous chemotherapy for metastatic or locally recurrent breast cancer.
* Radiotherapy for treatment of metastatic disease.
* Other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix.
* Spinal cord compression or brain metastases.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization.
* Inadequate bone marrow, liver, or renal function.
* Uncontrolled hypertension.
Transcranial Direct Current Stimulation for Pain Treatment in Gulf War Illness.

The goal of this study is to investigate long-term modulation of pain pathways leading to a suppression of pain symptoms in Gulf War Illness patients by applying transcranial direct current stimulation.

Gulf War Illness is a chronic and multisymptomatic disorder affecting returning military veterans of the 1990-1991 Gulf war. Pain is a major complaint of Gulf War Illness patients and is a leading cause of disability in veterans diagnosed with musculoskeletal ailments including joint and muscle pain, muscle fatigue, difficulty with lifting objects, and extremity paresthesia's. As a result, the target of the present study is the treatment of the pain symptoms, as this is detectable across all Gulf War Illness case classification systems.

Transcranial Direct current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has already demonstrated to improve pain symptoms in other patient populations, e.g. fibromyalgia patients. To investigate whether we can improve pain symptoms in GWI patients with pain complaints, we will compare behavioral (questionnaires) and electrophysiological (Electroencephalography) measures before and immediately after 10 sessions of tDCS and on several follow up sessions after the last tDCS from 2 groups.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female US military veterans serving during the 1990-1991 Gulf War.
2. Men and women between the ages of 18 and 50 years old during service in the Gulf War (born between 1940 and 1973).
3. English speakers.

Exclusion Criteria:

1. Non-English speakers.
2. History of a neurological disorder, including dementia of any type, moderate to severe traumatic brain injury (TBI), brain tumors, present or past drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, Huntington's disease, or multiple sclerosis. Traumatic brain injury will be screened by history.
3. No subjects will be enrolled who are cognitively or clinically incompetent to give informed consent.
4. Subjects cannot be taking medications that include: amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole,or citalopram.
5. Subjects with cardiac pacemakers, implanted medication pumps of any sort, or a history of bad heart disease, a history of seizures and/or family members with a history of seizures, and/or the presence of any metal objects in or near the head which cannot be safely removed for the duration of this study.
Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Iodine I 131 Tositumomab

This is a multi-center study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on Studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long-term safety. Additionally Laboratory evaluations consisting of a TSH level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have enrolled in one of the following Corixa sponsored clinical trials: CP-97-011, CP-98-025, CP-99-032, or CP-99-036 and are \>2 years post treatment with Iodine I 131 Tositumomab.
* Patients must give written informed consent by signing an IRB/ethics committee approved consent form prior to entry on this follow-up study.

Exclusion Criteria:

* Inability to meet above referenced inclusion criteria.
Zika and Neurodevelopment Among Infants in Grenada

Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children.

The intervention group received up to twelve 1-hour weekly visits by trained and experienced Grenadian parent and infant relationship specialists who provided home-based interventions as part of the Saving Brains Grenada project.

The environmental enrichment intervention is a brain-based program that teaches parents about brain development in young infants and skills for building a strong social-emotional connection that stimulates brain development and maximizes neurocognitive function. A detailed intervention manual was developed and used as a guide for the intervention specialists. Neurocognitive outcomes in the intervention and control group were assessed pre and post intervention by a separate and blinded assessment team.

Eligibility Criteria:
Inclusion Criteria:

* Must be actively enrolled in the pre-existing Zika Cohort Study
* Infant must be alive and living with a parent/guardian at the time of recruitment
* Infant must be between 24-27 months at the time of recruitment

Exclusion Criteria:

* Any infants older than 27 months
* Persons not enrolled in the pre-existing Zika Cohort Study